WO2007142830A2

WO2007142830A2 - Vertebral treatment device , system and methods of use

Info

Publication number: WO2007142830A2
Application number: PCT/US2007/012262
Authority: WO
Inventors: Joseph W. Yedlicka; Robert A. Till, Jr.; Nancy S. Yedlicka; Patricia M. Till
Original assignee: Osteo Innovations, Llc
Priority date: 2006-06-01
Filing date: 2007-05-23
Publication date: 2007-12-13
Also published as: EP2023823A2; CA2653976A1; EP2023823A4; WO2007142830A3

Abstract

A radiolucent bone drill and/or impact drill is provided, which includes a first portion connected to a second portion. The first portion defines a first axis and the second portion defines a second axis. The second axis is disposed at an angle relative to the first axis. A third portion is connected to the second portion. The third portion has a shaft extending therefrom. The shaft includes a distal end configured to engage bone. The bone drill may include a radiation protection guard mounted to the first portion. A cavity drill is provided, which is configured for use with a bone drill. A forceps and a fluid transfer device are provided, which are adapted to treat a vertebral body. A vertebral treatment system and methods of use are also provided.

Description

VERTEBRAL TREATMENT DEVICE, SYSTEM AND METHOD OF USE

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims priority to and is a continuation of U.S. Patent Application No. 11/788,413, filed April 20, 2007, U.S. Patent Application No. 11/788,415 filed April 20, 2007, U.S. Patent Application No. 1 1/788,414 filed April 20, 2007, and U.S. Patent Application No. 11/788,403 filed April 20, 2007, and claims the benefit of U.S. Provisional Patent Application Serial No. 60/809,945, filed on June 1, 2006, the contents of each of these disclosures being incorporated herein by reference in its entirety.

I. BACKGROUND OF THE INVENTION

A. Field of the Invention

The present invention relates to medical devices, components, and methods for use thereof, such as bone drills, bone drill assemblies, bone impact drills, bone cavity creation/enlargement devices, guide forceps, and fluid transfer device, especially those for treating vertebral body and sacral fractures, as well as lytic (destructive) tumor deposits in bone, for use in bone biopsies/bone infusions, for procedures requiring bone access and for use in medical procedures requiring a drill driven screwdriver or similar tools especially when there is a need for an off-angle, largely radiolucent bone access device having radiation protection for the operator designed to be used with X-ray (fluoroscopic) guidance and when there is a need for an improved device for creating/enlarging a cavity in a bone.

B. Background Information

Throughout the years and most recently in particular, various instruments have been developed for use in and for particular medical procedures and/or techniques requiring bone access. In some bone access procedures, it is necessary to create one or more holes in a bone or bone sections or to bore through the bone, Medical instruments known as bone drills have been developed for creating such holes and bores. Other instruments such as catheters, needles, guide needles, curettes and the like may then be introduced into the hole. On occasion, a cavity needs to be created or enlarged to facilitate treatment of a bone lesion.

Examples of medical procedures or techniques that require drilling into bone (and thus the use of a bone drill) often require creating a cavity or enlarging a cavity in the bone including vertebroplasty and/or vertebral augmentation procedures, sacroplasty, osteoplasty and bone biopsies/infusions. Other medical procedures require the use of drill-driven screwdrivers or similar tools which may need to be used with X-ray (fluoroscopic) guidance.

Vertebroplasty is a procedure for treating vertebral body (spinal) compression fractures. Sacroplasty is a procedure for treating sacral fractures. Osteoplasty is a procedure for treating painful lytic (destructive) tumor deposits in bone. Osteoporosis is the most common cause for vertebral compression fractures and sacral fractures but tumors involving the spine such as multiple myeloma and metastatic disease can also cause these fractures. A vertebral body compression fracture (VCF) is a fracture involving the vertebral body which causes the vertebral body to be compressed or to collapse. This can lead to shortening and tilting of the spinal column with a forward curvature. This forward curvature can lead to pulmonary and gastrointestinal complications. These fractures are extremely painful and debilitating with many of these patients needing wheelchairs for less painful ambulation; many of these patients are bedridden. Vertebroplasty is designed to stabilize VCFs and relieve pain. Vertebral height restoration and deformity reduction are also desired.

In vertebral augmentation and vertebroplasty, access needles are manually pushed or hammered into the fractured vertebral body using fluoroscopic (X-ray) guidance. Various instruments such as a curette may then be inserted through the access needles or tubes. At that point in vertebroplasty, an orthopedic bone filler/cement (e.g. PMMA) is instilled into the fractured bone. However, in vertebral augmentation, before the bone cement is instilled, balloon catheters are inserted through the access needles or tubes into the fractured vertebral body and inflated in an attempt to restore the compressed/collapsed vertebral body to its original height and also to create a cavity in the fractured bone. Following the balloon dilation, the balloons are removed and thicker bone cement is instilled into the fractured vertebral body through the access needles or tubes. The cement hardens quickly for both procedures, providing strength and stability to the vertebra. The progress of both procedures is continually monitored in real time with fluoroscopic (X-ray) guidance.

In sacroplasty, access needles are manually pushed or hammered into the fractured sacrum using fluoroscopic (X-ray) or computed tomographic (CT) guidance. Various instruments such as curettes or balloons may then be inserted through the access needles. An orthopedic bone filler/cement (e.g. PMMA) is then instilled through the access needles/tubes into the fractured sacrum. This has been found to provide pain relief and stability. Procedural progress is continually monitored with CT and/or fluoroscopic guidance.

In osteoplasty, access needles are manually pushed or hammered into the lytic (destructive) bone tumor deposit using fluoroscopic (X-ray) or computed tomographic (CT) guidance. Various instruments such as curettes, balloons, or radiofrequency (RF) probes may be inserted through the access needles. An orthopedic bone filler/cement (e.g.) PMMA is then instilled through the access needles/tubes into the lytic deposit. This has been found to provide pain relief and stability. Procedural progress is continually monitored with CT and/or fluoroscopic guidance. It has been recognized, however, that filler, such as the cement for the treatment procedures described above, can flow out through cracks in the targeted bone into undesired areas adjacent to the targeted bone such as the intervertebral disc, spinal canal, neural foramina, or blood vessels. This disadvantageously can result in undesirable health risks to a patient.

In bone biopsies, needles are manually pushed or hammered into the bone in order to obtain a specimen. In bone infusions, needles are manually pushed or hammered into the bone in order to achieve bone access.

It has been recognized that it is desirable for a bone drill / impact drill to place the access needles in the targeted bone in a single step using fluoroscopic (X-ray) or CT guidance. It has also been recognized that it is desirable for this bone drill / impact drill to have a guide tube or access needle/conduit in conjunction with a drill bit, the guide tube surrounding the drill bit. The guide tube/access needle may then be used as a conduit into the targeted bone. Placing the access sheath/conduit/tube/needle in a single step increases speed and accuracy of access placement thus improving safety and decreasing radiation exposure to the operator. This drill/impact drill can also be used with various bits (such as a screwdriver) for various medical procedures. However, existing drills suffer from various design defects that make them unsuitable to be used with fluoroscopic (X-ray) or computed tomographic (CT) guidance for these procedures. It is often difficult to place needles or access devices into bone by manually pushing or hammering; also the currently used devices result in excessive radiation exposure to the operator (particularly the hands). Also, currently available bone curettes do not reliably create a cavity in the accessed bone and also result in excessive radiation exposure to the operator (particularly the hands).

It is thus evident from the above that there is a need for an improved bone drill and/or impact drill and related methods of use. It is evident that there is a need for improved drill bits to be used for these applications. It is evident from the above that there is a need for improved cavity creation/enlargement in the targeted bone. It is also evident that there is a need for operator radiation protection when using these devices. It is further evident that there is a need for a guide forceps to be used with these devices. It is also evident that there is a need for a fluid-transfer device to be used with these devices. It would also be desirable to overcome the disadvantages and drawbacks of the prior art with improved vertebral treatment devices and related methods of use. It would be desirable if the vertebral treatment device and methods disclosed include an improved fluid injection device that instills artificial materials, such as cement, into targeted bone to treat maladies of the vertebral body and sacrum. It would be highly desirable if such a fluid injection device reduced leakage of filler materials from a bone and the consequent health risks to a patient. It would also be desirable if a vertebral treatment system is provided, which includes a bone drill and/or a cavity drill. Desirably, the vertebral treatment system has a forceps that facilitates guidance and stability during a drilling procedure. It would be most desirable if the vertebral treatment system has a largely radiolucent forceps that facilitates guidance and stability during a drilling procedure, particularly those performed using fluoroscopic (X-ray) guidance.

II. SUMMARY OF THE INVENTION

An off-angle, largely radiolucent bone access drill and/or impact drill for placing in one step an access needle/tube/conduit into the targeted bone has been invented by applicant. The drill also has radio opaque markers allowing more accurate alignment of the bone drill during use under fluoroscopic guidance. These attributes allow more accurate, rapid, and safe placement of the access needle/tube/conduit into the targeted bone. The present invention also reduces radiation exposure to the physician by allowing his/her hands to be further from the radiation source and patient. Radiation protection to the operator's hand is also provided by a radiation protection guard on the drill handle. The drill / impact drill is also designed to be used with various bits (e.g. screwdriver) for various medical procedures.

In one form, there is provided a bone drill / impact drill for performing the. various medical procedures (e.g., vertebroplasty and/or vertebral augmentation procedures, sacroplasty, osteoplasty, bone biopsies/infusions, and other procedures requiring the use of such a drill/impact drill). Portions of the bone drill are radiolucent, while radio opaque markers allow alignment of the bone drill during use (e.g. under fluoroscopy). At least a head portion of the bone drill is formed of the radiolucent material while a drill bit and access needle/sheath/conduit are formed of a radio opaque material. The drill is off-angle reducing radiation exposure by allowing for the operator's hands to be kept out of and further away from the path of the primary X-rays. A radiation protection hand guard on the drill handle provides additional radiation protection to the operator's hand.

In one form, there is provided a bone drill / impact drill assembly especially for performing the above described bone procedures. The bone drill assembly includes a drilling assembly including a drill bit and sheath assembly extending over/outside the drill bit. The sheath assembly is rotated independent of the drill bit and subsequent to drilling of a hole to a partial depth by the drill bit. An oversized hole is created that retains the sheath assembly for use as an instrument tube/conduit.

In one form, there is provided a method of use of the above bone drill / impact drill and bone drill assembly. In one form, there is provided various embodiments of drilling assemblies for an off-angle bone drill including rotating and non-rotating (cutting and non-cutting) sheaths and two-part drill bits.

The present invention thus provides an off-angle bone drill / impact drill that reduces radiation exposure to the operator by allowing his/her hands and body to be further from the primary radiation source and the patient (scatter radiation). A radiation protection hand guard on the drill handle also provides radiation protection to the operator's hand(s). The bone drill / impact drill is also largely radiolucent with radio opaque markers for aligning the bone drill. Moreover, the drill and sheath assembly provide bone drilling and conduit insertion in one step. The present invention also provides a cavity creation/enlargement tool or device (curette). The curette may be used in conjunction with the present bone drill assembly. The present invention also includes a guide forceps to be used with the devices. The present invention also includes a fluid transfer device. A kit containing some or all of the devices (bone drill, sheath, drill bit, curette, forceps, fluid transfer device and other components all in one or more sizes) may be provided.

In one particular embodiment, in accordance with the principle of the present disclosure, a bone drill / impact drill is provided, which includes a first portion connected to a second portion. The first portion defines a first axis and the second portion defines a second axis. The second axis is disposed at an angle relative to the first axis. A third portion is connected to the second portion. The third portion has a shaft extending therefrom. The shaft includes a distal end configured to engage bone. The bone drill may include a radiation protection guard mounted to the first portion.

At least a portion of the bone drill / impact drill can be radiolucent. The bone drill may include radio opaque markers configured for alignment of the bone drill during a fluoroscopy procedure. The third portion may be formed of the radiolucent material and the shaft formed of a radio opaque material. The third portion may include a drilling assembly having a drill bit and a sheath of the shaft extending about the drill bit. The sheath can be configured to rotate independent of the drill bit and subsequent to drilling of a hole to a partial depth by the drill bit. The shaft may be configured to rotate relative to the third portion. The third portion can define a third axis, the third axis being disposed at an angular orientation relative to the second axis.

The sheath can be configured to rotate in either direction such that the distal end rotates in a clockwise direction or a counterclockwise direction. The shaft may be configured for axial movement relative to the third portion. The axial movement can be spring driven to facilitate an impact engagement of the distal end and the bone. This impact engagement helps to facilitate starting the hole in the desired location. When starting holes with rotary bits, especially on uneven surfaces as would be found on bone, the drill bit tends to walk along the surface instead of biting in. The impact energy directed along the axis of the drill bit helps to imbed the bit in the bone allowing it to bite and start the hole without wandering out of position.

In an alternate embodiment, a method for treating a vertebral body is provided, the method including the steps of: providing a bone drill, similar to those described; exposing an area including the bone drill and the bone to radiation to facilitate alignment, via the radiolucent markers, of the sheath with the bone while protecting a user by maintaining the second axis at the angular orientation relative to the first axis; engaging the distal end of the shaft with the bone; rotating the drill bit and engaging the drill bit with the bone to create a cavity in the bone; driving the sheath into engagement with the bone to further define the cavity in the bone; and treating the bone.

The step of treating may include treating vertebral compression fractures. The step of treating may include treating includes treating sacral fractures. The step of treating may include treating lytic tumor deposits in the bone. The step of treating may include providing access for bone biopsies and/or infusions. The step of treating may include using the drill/impact drill device for use with different bits (such as screwdrivers) for performing various medical procedures. The step of treating may include driving an access needle into the bone using fluoroscopic guidance. The step of treating may include inserting a curette through the access needle in order to create a cavity in the bone. The step of treating may include inserting balloon catheters through the access needle into the bone and inflating the balloon catheter to restore the bone to a desired height and create a cavity in the bone. The step of treating may include instilling filler/cement into the targeted bone. The method for treating a vertebral body may include the step of inserting an access needle into a sacrum using guidance. The method for treating a vertebral body may include the step of inserting an access needle into the lytic bone tumor deposit using guidance.

The method for treating a vertebral body may include the step of irrigating the cavity. The method for treating a vertebral body may include the step of suctioning the cavity. The method for treating a vertebral body may include the step of inflating the cavity.

In one form, there is provided a bone drill having a cavity drill assembly especially for performing the above described bone procedures. The bone drill assembly includes a drilling assembly including a drill bit and sheath assembly extending over/outside the drill bit. The sheath assembly is rotated independent of the drill bit and subsequent to drilling of a hole to a partial depth by the drill bit. An oversized hole is created that retains the sheath assembly for use as an instrument tube/conduit.

Also provided is a cavity creation/enlargement device designed to be inserted into the bone drill and driven by the bone drill. In one particular embodiment, in accordance with the principles of the present disclosure, a cavity drill/creation/enlargement device is provided, which is configured for use with a bone drill. The cavity drill includes a body. The bone drill has a first portion movably connected to a second portion. A third portion is movably connected to the second portion. The body is mounted with the third portion of the bone drill. A cavity drill is affixed to the third portion of the bone drill. The cavity drill includes a tubular body/pusher/cutter within an outer tube and an end cap. The other end includes a plastic molded handle with snapping features to lock and release from the bone drill. Inside the outer tube is a pusher/cutting tube having its end cut to create a plurality of cutting blades. Holes allow the curette blades to be pushed out from the outer tube. A pusher controls the extension of the curette blades. Guides in the end cap aid in directing the blades. The tubular shaft assembly is inserted into the bone drill with the bone drill causing the blades to turn and create/enlarge a cavity in the targeted bone. The cutting blades may have radio opaque markers to increase conspicuity. The body supports gearing that operatively couples the sheath to a motor of the bone drill for rotation of the sheath. The sheath may be configured to rotate continuously in one direction or the other, or in an oscillating configuration such that the sheath rotates in a clockwise direction and in a counterclockwise direction.

At least a portion of the cavity creation/enlargement drill may be radiolucent. The cavity drill may include radio opaque markers configured for alignment of the sheath during a fluoroscopy procedure. The body can be formed of the radiolucent material and the sheath formed of a radio opaque material. The curette may be introduced into the targeted bone through the access conduit/sheath/tube placed into the bone with the bone drill.

The cavity drill may include a handle extending from the body. The handle is connected with the curette wherein the handle is manipulable in a configuration that causes movement of the curette's cutting blades. The handle can be connected to the curette in a gearing disposed with the body.

The sheath may be configured to rotate in an oscillating configuration such that the distal end rotates in a clockwise direction and a counterclockwise direction. The sheath can be configured for axial movement relative to the body. The third portion may be disposed at an angular orientation relative to the first portion of the bone drill. The cavity drill may include a radiation protection guard mounted to the bone drill.

In another embodiment, a bone drill configured for treating bone of a vertebral body is provided. The bone drill includes a handle connected to a drive housing. The drive housing is connected to a head portion. The head portion includes a shaft extending therefrom. The shaft includes a drill bit and a sheath disposed about the drill bit. The shaft is coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath. A cavity drill is mounted with the head portion and includes the sheath. The sheath has a curette disposed at a distal end thereof. Specific drill bits designed for use with the drills disclosed herein are also described.

The head portion may include radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

In another embodiment, a cavity drill configured for use with a bone drill is provided. The cavity drill includes a body having a sheath extending therefrom and being mounted with the bone drill. The body supports gearing that operatively couples the sheath to a motor of the bone drill for rotation of the sheath. A cutting blade extends from the sheath and is configured to rotate in an oscillating configuration such that the cutting blade rotates in a clockwise direction and a counterclockwise direction.

The sheath can be configured for axial movement relative to the body. The axial movement may be spring driven to facilitate impact engagement of the sheath with bone of vertebral body. The cavity drill can include a handle extending from the body. The handle is connected with the curette wherein the handle is manipulable in a configuration that causes movement of a curette being disposed with a distal end of the sheath.

The gearing may be configured to convert a rotation of the motor to oscillation of the cutting blade. The cutting blade may excise a defined arc in bone. The defined arc is approximately 60 degrees.

The present disclosure provides an off-angle bone drill that reduces radiation exposure to the operator by allowing his/her hands and body to be further from the primary radiation source and the patient (scatter radiation). A radiation protection hand guard on the drill handle also provides radiation protection to the operator's hand(s). The bone drill is also largely radiolucent with radio opaque markers for aligning the bone drill. Moreover, the drill and sheath assembly provide bone drilling and conduit insertion in one step. The present disclosure also provides a cavity creation/enlargement tool or device (curette). The curette may be used in conjunction with the present bone drill assembly.

In another embodiment, an improved vertebral treatment device and related methods of use are provided for overcoming the disadvantages and drawbacks of the prior art. Desirably, the vertebral treatment device and methods disclosed include an improved bone drill and related methods of use. Desirably, a vertebral treatment system is provided that advantageously protects an operator from radiation to minimize the consequent health risks to a patient. Most desirably, the vertebral treatment system has a largely radiolucent forceps that facilitates guidance and stability during a drilling procedure. The forceps may have a radiation protection guard on its handle.

In one particular embodiment, in accordance with the principles of the present disclosure, a radiolucent forceps is provided, which is adapted for treating a vertebral body. The forceps may have a radiation protection guard on its handle. Radiation exposure to the operator's hand is decreased by increasing the distance between the patient/X-ray beam and the operator's hand and is also decreased by a radiation protection guard. The forceps has a handle including an actuator pivotably connected therewith. A shaft extends from the handle. A proximal end of the shaft operatively engages the actuator. An elongated member extends through the shaft and has a proximal end and a distal end. The proximal end is affixed to the handle and the distal end includes opposing arms configured to grasp. Alternatively, the actuator may operatively engage the shaft to cause axial movement thereof relative to the elongated member. The shaft can be axially moveable between a retracted position, whereby the arms are in a substantially open position, and an extended position, whereby the arms are in a substantially closed position. The arms may define a cylindrical cavity in the closed position. The arms may be outwardly biased.

In another alternate embodiment, a vertebral treatment system is provided. The vertebral treatment system includes a bone drill configured for treating bone of a vertebral body. The bone drill includes a handle connected to a drive housing. The drive housing is connected to a head portion.. The head portion includes a shaft extending therefrom. The shaft includes a drill bit and a sheath disposed about the drill bit. The shaft is coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath.

Alternatively, the vertebral treatment system may further include a cavity drill having a body with a sheath extending therefrom and being mounted with the bone drill. The body supporting gearing that operatively couples the sheath to a motor of the bone drill for rotation of the sheath. The vertebral treatment system may further include a forceps, similar to those described herein. The head portion of the bone drill may include radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

In another embodiment, the vertebral treatment device and methods disclosed include an improved fluid/transfer injection device that instills artificial materials, such as cement, into targeted bone to treat maladies of the vertebral body and sacrum. The fluid/transfer injection device may be advantageously employed to reduce leakage of filler materials from a bone and minimize the consequent health risks to a patient. It would also be desirable if a vertebral treatment system is provided. Desirably, the vertebral/bone treatment system has a largely radiolucent, off-angle bone drill, cavity creation/enlargement device as well as a forceps that facilitates guidance and stability during a drilling procedure.

In one particular embodiment, in accordance with the principles of the present disclosure, a fluid transfer device is provided, which is adapted to treat a vertebral body, sacrum, or other bony lesion. The fluid transfer device includes a first cavity having a first plunger disposed therewith. The first plunger is configured to draw a first fluid into the first cavity. A second cavity has a second plunger disposed therewith. The second plunger is configured to expel a second fluid from the second cavity. An actuator is connected to the first plunger and the second plunger. The fluid transfer device may have a pressure gauge and automatic stop designed to prevent excessive pressure buildup in the targeted bone and to minimize the risk of cement/filler/fluid leak.

The configuration of the fluid transfer device creates a preferred pathway between the second cavity, such as, for example, a delivery syringe and bony cavities to improve the flow of filler/cement in order to get more uniform filling/distribution of the filler/cement throughout the targeted bone; the configuration also minimizes undesired filler/cement leak into undesired adjacent structures such as the inter-vertebral disc, spinal canal, neural foramina, and blood vessels.

The fluid transfer device may further include a body having a first cylinder. The first cylinder defines the first cavity and supports the first plunger. The body may have a second cylinder, which defines the second cavity and supports the second plunger. The first cavity and the second cavity can communicate with a vertebral cavity of the vertebral body. The actuator may be operatively coupled to the first plunger and the second plunger via a gearing assembly.

The first plunger can include a shaft having teeth axially disposed therealong. The teeth engage the gearing assembly to facilitate movement of the first plunger. The second plunger may include a shaft having teeth axially disposed therealong. The teeth of the second plunger engages the gearing assembly to facilitate movement of the second plunger. The actuator may be rotatable such that the gearing assembly engages the shafts of the plungers to facilitate movement thereof. The body may include a handle.

The gearing assembly can include a first pinion gear that engages the teeth of the first plunger and a second pinion gear that engages the teeth of the second plunger. The pinion gears engage a gear that is operatively connected to the actuator.

In an alternate embodiment, a method for treating a vertebral body having a vertebral cavity is disclosed. The method includes the steps of: providing a fluid transfer device; and simultaneously withdrawing a first fluid from the vertebral cavity and instilling cement into the vertebral cavity.

In another alternate embodiment, a vertebral treatment system is provided. The vertebral treatment system includes a bone drill configured for treating bone of a vertebral body. The bone drill includes a handle connected to a drive housing. The drive housing is connected to a head portion. The head portion includes a shaft extending therefrom. The shaft includes a drill bit and a sheath disposed about the drill bit. The shaft is coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath. A fluid transfer device is provided, similar those described herein.

Alternatively, the vertebral treatment system may further include a cavity drill having a body with a sheath extending therefrom and being mounted with the bone drill. The body supporting gearing that operatively couples the sheath to a motor of the bone drill for rotation of the sheath. The vertebral treatment system may further include a forceps. The head portion of the bone drill may include radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

The various aspects of the present inventions will be more apparent upon reading the following detailed description in conjunction with the accompanying drawings.

III. BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and objects of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

Figure 1 is a perspective view of one particular embodiment of a bone drill constructed in accordance with the principles of the present invention;

Figure 2 is a bottom, side perspective view of the bone drill shown in Figure 1;

Figure 3 is a perspective view of the bone drill shown in Figure 1 having a guide/stabilizer; Figure 4 is an enlarged top, side perspective cutaway view of a head portion of the bone drill shown in Figure 1;

Figure 5 is an enlarged bottom, side perspective cutaway view of the head portion shown in Figure 1 ;

Figure 6 is an enlarged bottom, side perspective cutaway view of a portion of a boring assembly of the bone drill shown in Figure 1;

Figure 7 is a perspective view of the bone drill shown in Figure 1, with a body portion removed;

Figure 8 is an enlarged perspective cutaway view of the head portion shown in Figure 7;

Figure 9 is the enlarged perspective cutaway view of the head portion shown in Figure 8 with a gear portion removed;

Figure 10 is a side perspective view in cross section of the bone drill shown in Figure 1 ;

Figure 11 is an enlarged perspective view of the head portion shown in Figure 10;

Figure 12 is an exploded perspective view of the bone drill shown in Figure 1;

Figure 13 is an exploded bottom perspective view of the bone drill shown in Figure 1;

Figure 14 is an enlarged perspective view of coupling portions of the drill bit assembly of the bone drill of Figure 1;

Figure 15 is an enlarged perspective cutaway view of coupling portions of the drill bit assembly of the bone drill shown in Figure 1;

Figure 16 is an enlarged perspective cutaway view of one embodiment of a boring end of the drill bit assembly shown in Figure 1 with an inner bit retracted;

Figure 17 is an enlarged perspective view of the boring end shown in Figure 16 with the inner bit extended; Figure 18 is an enlarged perspective cutaway view of an alternate embodiment of the drill bit assembly shown in Figure 1;

Figure 19 is an enlarged perspective cutaway view of an alternate embodiment of the drill bit assembly shown in Figure 1 ;

Figure 20 is a perspective view of an alternate embodiment of the bone drill constructed in accordance with the principles of the present invention;

Figure 21 is a bottom perspective view of the bone drill shown in Figure 20;

Figure 22 is an enlarged bottom perspective cutaway view of a head portion of the bone drill shown in Figure 20;

Figure 23 is an enlarged top perspective cutaway view of the head portion shown in Figure 20;

Figure 24 is an enlarged top perspective view of the head portion shown in Figure 20 with parts separated;

Figure 25 is a side perspective view of the bone drill shown in Figure 20 with a cover removed;

Figure 26 is an enlarged cutaway view of a rear portion of the bone drill shown in Figure 25;

Figure 27 is an enlarged cutaway view of the head portion shown in Figure 25;

Figure 28 is an enlarged cutaway view of the head portion shown in Figure 27 with a gear removed;

Figure 29 is a perspective view of an alternate embodiment of the bone drill shown in Figure 20;

Figure 30 is a side view of the bone drill shown in Figure 29; Figure 31 is a perspective view, in cross section of the bone drill shown in Figure 29;

Figure 32 is a bottom perspective cutaway view of an alternate embodiment of the head portion of the bone drill shown in Figure 20;

Figure 33 is an enlarged bottom perspective view of the head portion shown in Figure 32;

Figure 34 is a perspective cutaway view of a sheath shown in Figure 32;

Figure 35 is an enlarged side perspective sectional view with cover removed, of an alternate embodiment of the head portion shown in Figure 20 constructed in accordance with the principles of the present invention;

Figure 36 is an enlarged side perspective view, in cross section of the head portion shown in Figure 35;

Figure 37 is an enlarged perspective exploded view of separated components of the head portion shown in Figure 35;

Figure 38 is a side perspective view of an alternate embodiment of the bone drill shown in Figure 20 constructed in accordance with the principles of the present invention;

Figure 39 is a side perspective sectional view with cover removed of the bone drill shown in Figure 38;

Figure 40 is an enlarged side perspective view, in cross section of the head portion shown in Figure 38;

Figure 41 is an enlarged side perspective view, in cross section of the head portion shown in Figure 38;

Figure 42 is an enlarged side perspective view, in cross section of the head portion shown in Figure 38;

Figure 43 is an enlarged front perspective view, in cross section of the head portion shown in Figure 38; Figure 44 is a side perspective sectional view with cover removed of the bone drill shown in Figure 38;

Figure 45 is a side perspective sectional view with cover removed of the head portion of bone drill shown in Figure 38;

Figure 46 is a perspective view of one particular embodiment of a bone drill having a cavity drill constructed in accordance with the principles of the present disclosure;

Figure 47 is an enlarged top perspective cutaway view of a head portion of the bone drill shown in Figure 46;

Figure 48 is a perspective cutaway view of a distal portion of a bone curette constructed in accordance with the principles of the present disclosure;

Figure 49 is a perspective view of a cavity drill shown in Figure 46, separated from the bone drill;

Figure 50 is a side perspective view of the cavity drill shown in Figure 49;

Figure 51 is a side enlarged view, in cross section of a head portion of the cavity drill shown in Figure 49;

Figure 52 is a side enlarged view, in cross section of the head portion shown in Figure 49;

Figure 53 is an enlarged view of the head portion shown in Figure 49, with a body portion removed;

Figure 54 is an exploded perspective cutaway view of a distal portion of a bone curette constructed in accordance with the principles of the present disclosure;

Figure 55 is a perspective view of the curette shown in Figure 54 in a retracted position;

Figure 56 is a perspective view of the curette shown in Figure 54 in a minimally extended position; Figure 57 is a perspective view of the curette shown in Figure 54, in an intermediately extended position;

Figure 58 is a perspective view of the curette shown in Figure 54 in a maximally extended position;

Figure 59 is a perspective view of an alternate embodiment of the cavity drill constructed in accordance with the principles of the present disclosure;

Figure 60 is a perspective view of an alternate embodiment of a bone curette constructed in accordance with the principles of the present disclosure;

Figure 61 is an enlarged top perspective cutaway view of the cavity drill shown in Figure 59;

Figure 62 is an enlarged top perspective view of the cavity drill shown in Figure 59 with a body portion removed;

Figure 63 is an enlarged top perspective view of the cavity drill shown in Figure 59 with parts removed;

Figure 64 is an enlarged top perspective view of the cavity drill shown in Figure 59 with parts removed;

Figure 65 is an enlarged top perspective view of the cavity drill shown in Figure 59 with parts removed;

Figure 66 is a perspective view of the cavity drill shown in Figure 59 with parts separated in an exploded view;

Figure 67 is a side perspective view of an alternate embodiment of the bone drill shown in Figure 46 constructed in accordance with the principles of the present invention;

Figure 68 is a side perspective sectional view with cover removed of the bone drill shown in Figure 67; Figure 69 is an enlarged side perspective view, in cross section of the head portion shown in Figure 67;

Figure 70 is an enlarged side perspective view, in cross section of the head portion shown in Figure 67;

Figure 71 is an enlarged side perspective view, in cross section of the head portion shown in Figure 67;

Figure 72 is an enlarged front perspective view, in cross section of the head portion shown in Figure 67;

Figure 73 is a side perspective sectional view with cover removed of the bone drill shown in Figure 67;

Figure 74 is a side perspective sectional view with cover removed of the head portion of bone drill shown in Figure 67;

Figure 75 is a perspective view of a device employed in a vertebral treatment procedure constructed in accordance with the principles of the present disclosure;

Figure 76 is a side perspective view of the device shown in Figure 75;

Figure 77 is a side perspective view, in cross section, of the device shown in Figure 75;

Figure 78 is an enlarged perspective view, in cutaway, of a distal end of the device shown in Figure 75;

Figure 79 is a perspective view of a bone drill constructed in accordance with the principles of the present disclosure;

Figure 80 is a perspective view of an alternate embodiment of a bone drill / cavity drill constructed in accordance with the principles of the present disclosure;

Figure 81 is a perspective view of one particular embodiment of a vertebral treatment device constructed in accordance with the principles of the present disclosure; Figure 82 is a rear perspective view of the vertebral treatment device shown in Figure 81 ;

Figure 83 is a front perspective view of the vertebral treatment device shown in Figure

81;

Figure 84 is a front perspective view of the vertebral treatment device shown in Figure 81, with the cylinder bodies removed;

Figure 85 is a top perspective view of the vertebral treatment device shown in Figure 81, with a body portion removed;

Figure 86 is a rear perspective view of the vertebral treatment device shown in Figure 81, with the body portion removed;

Figure 87 is a perspective view of a bone drill constructed in accordance with the principles of the present disclosure;

Figure 88 is a perspective view of an alternate embodiment of the bone drill shown in Figure 87, constructed in accordance with the principles of the present disclosure;

Figure 89 is a perspective view of a device employed in a vertebral treatment procedure constructed in accordance with the principles of the present disclosure; and

Figure 90 is a diagram of a procedure employing the vertebral treatment device shown in Figure 81.

Like reference numerals,indicate the similar parts throughout the figures.

IV. DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The exemplary embodiments of the bone drill and/or impact drill and methods of use disclosed are discussed in terms of medical apparatus and more particularly, in terms of bone drills, bone drill assemblies and bone cavity drills that can be employed for treating vertebral body and sacral fractures. The bone drill may also be employed to treat lytic tumor deposits in bone. It is envisioned that the present disclosure may be employed with a range of applications including vertebroplasty and/or vertebral augmentation procedures, sacroplasty and osteoplasty. It is envisioned that the present disclosure may be used to provide access for bone biopsies and bone infusions. It is also envisioned that these devices may be used with different drill bits (such as screwdrivers) for various medical procedures. It is further envisioned that the present disclosure may be used with other medical applications such as diagnosis, treatment and surgery.

The following discussion includes a description of the bone drill, related components and exemplary methods of operating the bone drill in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to FIG. 1, there is illustrated a bone drill 10, in accordance with the principles of the present disclosure.

The components of bone drill 10 are fabricated from materials suitable for medical applications, such as, for example, polymeries and/or metals, depending on the particular application and/or preference. Semi-rigid and rigid polymeries are contemplated for fabrication, as well as resilient materials, such as molded medical grade polyurethane, etc. The motors, gearing, electronics and power components of bone drill 10 may be fabricated from those suitable for a medical application. Bone drill 10 may also include circuit boards, circuitry, processor components, etc. for computerized control. One skilled in the art, however, will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate.

Detailed embodiments of the present disclosure are disclosed herein, however, it is to be understood that the described embodiments are merely exemplary of the disclosure, which may be embodied in various forms. Therefore, specific functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed embodiment.

Referring to Figures 1-13, bone drill 10 includes a drill body 12 and a drilling assembly 20. Bone drill 10 is adapted to bore a hole into bone such as, for example, into a vertebra or vertebral body during a vertebroplasty procedure and under fluoroscopy. As such, various components, as desired, of bone drill 10, are formed of a radio translucent (radiolucent) material. Thus, only those components that are not radiolucent will show up under x-ray and/or during real time fluoroscopy. It should be appreciated that bone drill 10 is adapted to perform various surgical drilling procedures other than for a vertebroplasty procedure.

In one form, bone drill 10 is adapted to create or drill a bore in bone of a vertebral or sacral body, and to introduce and temporarily leave a tube, tubular sheath or the like of bone drill 10 in the bore. A tubular sheath of bone drill 10 is configured to allow an instrument, component, tool or the like to pass therethrough and provide access to an area at or adjacent to the distal end of the tubular sheath.

Drilling assembly 20 includes a sheath assembly 56 having a tubular sheath 57 and a proximal end terminating in a drive head 60. Drive head 60 includes multiple projections on an outer periphery thereof. Sheath assembly 56 (and thus sheath 57) has a proximal end (see, e.g. Figure 6) that is preferably serrated or includes drilling teeth 84. Drilling assembly 20 further includes a drill bit 58 having a tipped body 86 and two spiral cutting edges 88, 90. Drill bit 58 is fashioned of a suitable metal. Sheath 57 is also fabricated from metal and thus drilling assembly 20 is not radiolucent.

Body 12 is formed of two (a first and second) portions, sections or halves 25 and 27. The two halves 25, 27 may be considered as upper and lower halves 25, 27. The two halves 25 and 27, when joined, define a first portion, such as, for example, a handle portion 14, a second portion, such as, for example, a drive portion 16 and third portion, such as, for example, a head portion 18. A connecting portion 40 is defined between handle portion 14 and drive portion 16 while a neck 48 is defined between drive portion 16 and head portion 18. Upper and lower halves 25, 27 are formed of a surgically-acceptable material such as a plastic, composite or the like.

Upper and lower halves 25, 27 forming handle portion 14 define a generally tubular body 24. Upper half 25 of the body has a palm area 26. Body 24 also includes an opening 31 (see Figure 13) on another side thereof (in lower half 27) through which a trigger switch or on/off button 30 extends. In a preferred form, bone drill 10 has a trigger style switch for variably controlling rotational speed of the shaft. Bone drill 10 may also include a reversing (rotation direction) switch. As shown in Figures 7, 12 and 13, button 30 pivots and is operatively coupled with and actuates speed controller 96 for bone drill 10. A finger grip area 28 is disposed adjacent to control button 30. As shown in Figure 2, finger grip area 28 includes three finger indentions 33, 34, 35 that each accommodate a finger of a user's hand as the user is gripping handle portion 14. The two halves 25, 27 form an interior cavity or area 92, which houses a battery or battery pack 94.

Body 12 includes a projection 42 formed on connecting portion 40 and particularly upper half 25, that is adjacent handle portion 14. Projection 42 is generally arc-shaped and defines first and second sides 43, 44 that are generally perpendicular (to slightly angled inwardly toward an apex of projection 42) to the longitudinal axis of first portion 14. An operator or user of bone drill 10 may utilize projection 42 to position the operator's thumb onto bone drill 10.

Drive portion 16 is defined by a generally tubular body 38 defined from appropriate portions of upper and lower halves 25, 27. As shown, for example, in Figures 7, 10, 12 and 13, a motor 98 is disposed within tubular body 38. Motor 98 is appropriate for power supply 94 (e.g. batteries) and can be an AC or DC motor. Motor 98 is electrically coupled to batteries 94 and speed controller 96 such that depressing trigger 30 actuates controller 96. The more trigger 30 is depressed the greater the speed of the shaft of bone drill 10.

The upper and lower halves 25, 27 define a neck or neck portion 48 that provides connection between the drive portion body 38 and head portion 18. Head portion 18 has a generally cylindrical/annular body 52 that is defined by a top head section 53 and a bottom head section 54. As shown in Figures 8 and 9, for example, body 52 defines an interior cavity 55 that houses the drilling assembly drive gearing.

Motor 98 includes gearing 99 (see, e.g., Figure 11) that is operatively coupled to the motor and to an output assembly 101 such that rotation of the motor shaft via gearing 99 rotates output shaft 101. An output drive sleeve 100 is connected to output shaft 101 for rotation therewith. Output drive sleeve 100 is retained for rotation in a mount 118 formed on the inside of neck 48 (see, e.g. Figures 8 and 11). A bevel gear 102 is connected to the output drive sleeve for meshing/engaging with the drilling assembly gearing in head portion 18. As shown in Figure 8, bevel gear 102 meshes with an input gear 104 of the drilling assembly gearing. Input gear 104 is retained on shaft end 106 of drill bit 58 via a retention washer 107 and includes teeth on an outer radial periphery thereof that meshes with the teeth of bevel gear 104. Thus, as bevel gear 102 rotates input gear 104, input gear 104, coupled to drill bit 58 via retention washer 107, rotates drill bit 58. As shown in Figures 9 and 11, input gear 104 consists of a larger bevel gear mated to a smaller spur gear. The spur gear meshes with the three planetary gears 112, 114, and 116 which in turn mesh with lower gear ring 110. Lower gear ring 110 is fixed against rotation and includes teeth on the radially inside periphery thereof. An annular plate 108 carrying three gears 112, 114 and 116 via respective gear shafts 113, 115 and 117 is situated radially inside input/lower gears 104/110. Gears 112, 114, 116 are rotated by input gear 104 and process along the lower gear ring 110. The procession of the planet gears along ring gear 110 rotates plate 108. A drive cylinder 78 is connected to the lower portion of plate 108 so as to rotate therewith. Drive cylinder 78 is adapted to engage and drive (rotate) sheath assembly 56 of drilling assembly 20 via the head.

It is envisioned that sheath 57 rotates at a first speed and drill bit 58 rotates at a second speed. The planetary gear drive (plastic and radiolucent portions of head portion 18) in head portion 18 meshes with the gear head of motor 98 to spin drill bit 58 at a first speed. The gear head on motor 98 reduces the speed, used to spin drill bit 58, to a second speed for rotating sheath 57. The planetary gear set in the drill head is used to drive the sheath at the second or reduced speed for better feed rate control. The drill bit spins at the first or faster speed to do the bulk of the bone removal while the slower sheath cutting speed keeps the drill bit from "digging in" and bogging down motor 98. It is contemplated that the first and second speeds may vary in range, may be equal and/or the first speed may be less than the second speed.

Optionally, if the ring gear of the planetary gear train in the gear head is left free to rotate (i.e. it is not fixed to the housing), the drive for the sheath will remain stationary. To then engage the sheath, a braking force is applied to the ring gear through a trigger on the handle. Slowing and/or stopping the ring gear will cause the sheath drive to rotate at a variable rate. This configuration is a feed rate or speed control for the sheath rotation giving the user a finer control on how fast the sheath/drill plunges into the bone. It is envisioned that sheath 57 rotates in a first direction and drill bit 58 rotates in a second direction, such as clockwise and counter-clockwise. The sheath may be moved in a counter direction (counter rotation) to the drill bit. This is accomplished by holding the planetary gear plate 108 stationary and attaching the sheath drive plate to the ring gear, which is now free to rotate. The ring gear will spin hi the opposite direction as the sun gear (drill bit), at a reduced speed.

Referring to Figure 5, end 80 of drive cylinder 78 of bone drill 10 is adapted to frictionally engage an upper surface 61 of drive head 60. Thus, when end 80 of drive cylinder 78 engages drive head 60 of sheath assembly 50, sheath 57 rotates to ream the bore started by and/or being cut by drill bit 58. Thus, a bore is created that allows sheath 57 to extend therein. Thus, one mode of driving sheath assembly 50 is by friction via a friction plate.

Cutting sheath 57 is, thus, not driven initially. It remains stationary to guide drill bit 58 when starting a hole. As drilling progresses, drive head 60 is frictionally engaged by drive cylinder 78 such that the sheath assembly is subsequently (after the start of drill bit rotation), rotated. This cuts a hole large enough for the sheath to follow the drill bit into the bone.

Referring to Figures 14 and 15, an alternate mode of driving sheath assembly 20 by bone drill 10 is shown, illustrating an embodiment of a direct engagement manner of driving the sheath. Top surface 61 of drive head 60 includes a plurality of notches 140. Notches 140 are depicted as trapezoidal and radiating from a longitudinal axis of sheath 57. The drive gearing for head portion 18 includes an annular drive gear 130 with angled teeth for engaging bevel gear 104. A shaft 134 extends from an undersurface 131 of gear 130 and terminates in a drive wheel 136. Drive wheel 136 has a plurality of teeth 137 corresponding in number and configuration to notches 140 of the drive head. In this manner, once teeth 137 engage notches 140, rotation of drive wheel 37 will be imparted to the sheath assembly through direct engagement.

In this instance, cutting sheath 57 is, thus, not driven initially. It remains stationary to guide drill bit 58 when starting a hole. As drilling progresses, the sheath assembly is subsequently (after bit rotation) engaged to start rotating the sheath assembly.

As shown in Figure 1, by the respective x-y coordinate arrows, handle portion 14 defines a longitudinal axis (x-axis), drive portion 16 defines a longitudinal axis (x-axis), and head portion 18 defines a longitudinal axis (x-axis). Head portion 18 defines a y-axis (which is co axial with drill bit 58). It can be appreciated from Figure 1 that drive portion 16 is offset from handle portion 14, along with head portion 18. Head portion 18 may be offset from drive portion 16. It is envisioned that the longitudinal axis of drive portion 16 may be coaxial with the longitudinal axis of handle portion. 14, and the longitudinal axis of head portion 18 offset from the drive/handle portions. These configurations allow a safe distance between a doctor's hand and radiation. A range of relative angular offset may be employed.

In an alternate embodiment, Figure 3 shows bone drill 10 with an optional drilling guide 70 that may be used to hold and/or stabilize drilling assembly 20 during use. Drilling guide 70 is preferably formed of a radiolucent material. Drilling guide 70 includes a frustoconical shaped body 74 having a central bore 76. A rod 72, in a handle configuration, extends generally perpendicular to the axis of bore 76. Bore 76 is sized to allow the sheath 76 to extend there through.

Figure 4 provides a perspective view of head portion 18 showing four radio opaque markers 64 (i.e. 64a, 64b, 64c, 64d) radially surrounding the longitudinal axis of drill bit 58, the longitudinal axis thereof forming a center point for radio opaque markers 64. The four radio opaque markers provide reference points for aligning the drill bit. Other configurations and/or scales may be provided as radio' opaque markers.

It should be appreciated that drilling assembly 20 (drill bit 58 and sheath 57) is sized to provide a full sized hole in a single pass. Moreover, drilling assembly 20 is sized such that drill bit 58 extends beyond end 84 of sheath 57 (see, e.g. Figures 1 and T). Particularly, the length of sheath assembly 56 (sheath 57 and drive head 60) allows an end 86 of drill bit 58 to extend beyond end 84 of sheath 57 while drive head 60 does not abut or engage drive surface 80 of drive unit 78. It is contemplated that sheath 57 may include a plurality of cutting tines configured to engage and cut bone. It is further contemplated that the tines are moveable relative to the distal end of sheath 57.

Referring to Figures 16 and 17, there is depicted another alternate embodiment of a bone drill bit assembly designated 170 for use with bone drill 10. Assembly 170 includes a non- rotating sheath 172 having a distal end 174, an oversized drill bit 176, and a small inner drill bit 177. Drill bit 176 includes a shank 178 that is sized for receipt in sheath 172, and a head 176 extending from shank 178. Shank 178 and, thus, head 176 are formed of two spiral cutting edges 180 and 184 with a central bore therein. Inner drill bit 177 is formed of 2 spiral cutting edges whose outside bore is sized to fit within the inside bore 186 of drill bit 176. It is inserted into 178 after 178 is inserted into sheath 172. During drilling, head section 184 cuts a larger bore allowing the sheath to follow it into the hole. Once the hole is complete, inner drill 177 is removed. Without the inner drill, head section 184 will collapse and pass through the inner bore of sheath 172 and can be completely withdrawn leaving the sheath in place.

Referring to Figure 18, there is depicted an alternative sheath embodiment 190 wherein sheath 192 has, beginning at an end 194 thereof, an upper shank portion 196 with external threads 198 thereon. End teeth or serrations 200 are provided on shank 198. A drill bit 202 includes cutting spirals 204, 206 configured to extend through, sheath 196. This alternate design controls depth feed rate. By controlling the drill/sheath speed (e.g. variable speed control) or the sheath speed alone (e.g. ring gear brake), the user knows how fast the drill bit plunges into the bone based on the thread pitch of external threads 198.

Referring to Figure 19, there is depicted another alternative embodiment of a sheath assembly generally designated 210. In this embodiment, sheath assembly 210 includes a proximal tubular sheath portion 212 and a distal tubular sheath portion 216. An oversized drill bit 220 is shown extending from non-serrated end 218 of distal tubular sheath portion 216. Oversized drill bit 220 includes a shank 222 with a head 224 extending from shank 222 via a taper portion 230. First and second spiral cutting edges 226, 228 are oversized at head portion 224 and expand after exiting sheath 216. Cutting edges 226, 228 include a central bore that allows an inner drill bit 232 to extend therethrough.

Sheath 216 includes external threads 217 in like manner to external threads 198 of sheath 196 of sheath assembly 190 shown in Figure 18. A radially extending stop 214, however, is provided between proximal and distal sheath portions 214, 216. Stop 214 is used as a depth control. Offset to the drill bit to sheath is a control mechanism on the drill head. Once the sheath's stop bottoms out on the outer surface on the bone, the drill will not be able to plunge any deeper. If it isn't deep enough, the doctor would back up the drill, adjust the depth setting, re-engage and finish drilling to the proper depth.

A bone curette/cavity drill may be used with a bone drill, particularly during the above described procedures wherein the drill has been removed and the access sheath/conduit remains in the bone. The curette can have a four-blade cutter that attaches and rotates with bone drill 10. It should be appreciated that the curette may have more or less blades as desired. Bone drill 10 is adapted to receive replaceable bits/tools. This may be accomplished by providing a releasable catch or the like.

Referring to Figures 20-28, in an alternate embodiment similar to that described with regard to Figures 1-13, a bone drill 410 is provided in accordance with the principles of the present disclosure. Bone drill 410 includes a drill body 412 and a drilling assembly 420. Bone drill 410 is configured for hole boring in bone, as described herein, and various components of bone drill 410, may be formed of a radiolucent material. It is envisioned that bone drill 410, or components thereof, are disposable after a vertebral body or sacral body procedure. Bone drill 410 and its components may also be reused. It is further envisioned that bone drill 410 is formed by radiolucent and radio opaque materials, similar to bone drill 10. Bone drill 410 may also include radio opaque markers for aligning the shaft, sheath and drill bit, similar to radio opaque markers 64 described with regard to bone drill 10.

Bone drill 410 is adapted to create or drill a bore in the bone, and to introduce and temporarily leave a tube, tubular sheath or the like of drilling assembly 420 in the bore. It is contemplated that the tubular sheath is configured to allow an instrument, component, tool or the like to pass therethrough and provide access to an area at or adjacent to the distal end of the tubular sheath.

Drilling assembly 420 includes a sheath assembly 456 having a sheath 457 and a proximal end terminating in a drive head 460. Drive head 460 includes multiple projections on an outer periphery thereof. Sheath 457 has a distal end. It is envisioned that the distal end of sheath assembly 456 may be serrated or include drilling teeth. Drilling assembly 420 includes a drill bit 458, similar to that described above. It is contemplated that sheath 457 is fabricated from metal. Body 412 is formed of a first portion 425 and a second portion 427. It is contemplated that portions 425, 427 may be symmetric halves, offset, non-symmetric, etc. Body 412 defines a handle 414, a drive housing 416 and a head portion 418. A connecting portion 440 is defined between handle 414 and motor housing 416. A neck 448 is defined between motor housing 416 and head portion 418.

Handle 414 defines a tubular body 424, which has a palm area 426. Body 424 also includes an opening 431 (Figure 25) in second portion 427 through which a switch 430 extends. It is contemplated that switch 430 may comprise a button configuration, which may include a trigger style for variably controlling the rotational speed of bone drill 410. It is further contemplated that switch 430 facilitates a reversing rotation.

As shown in Figures 25 and 26, button 430 is operatively coupled with a speed controller 496 for actuation of drill 410. A finger grip area 428 is disposed adjacent to button 430, which includes three finger indentions that accommodate fingers of a user's hand for gripping handle 414. Portions 425, 427 form an interior cavity 492 in which a battery 494 is housed. Body 412 also includes a projection 442, similar to that described.

Drive housing 416 includes a motor assembly 498 disposed within tubular body 438. Motor 498 is electrically coupled to batteries 494 and speed controller 496 such that depressing trigger 430 actuates controller 496. It is contemplated that button 430 may be variably depressed to increase drill speed.

Head portion 418 has a body 452 including a drill bit handle 453 and a bottom support 454. Body 452 defines an interior cavity 455 that supports the drilling assembly drive gearing.

Motor assembly 498 is operatively coupled to an output shaft 501 for rotation thereof via gearing. Output shaft 501 is retained for rotation in a mount 518 formed on the inside of neck 448 (see Figures 27 and 28). A bevel gear 502 is connected to the output shaft 501 for meshing/engaging with the drilling assembly gearing in head 418.

As shown in Figures 27 and 28, bevel gear 502 meshes with an input gear 504 of the drilling assembly gearing. Input gear 504 is retained about a support cylinder 514, which is connected to drill bit 458. Input gear 504 includes teeth on an outer radial periphery thereof that meshes with the teeth of bevel gear 502. A gear 516 is mounted with support cylinder 514. Thus, as bevel gear 502 rotates input gear 504, input gear 504 rotates support cylinder 514 and gear 516, which rotates planetary gears 512. As shown in Figures 27 and 28, lower gear ring 510, which includes teeth on the radially inside periphery thereof, is held stationary inside head 418. A drive cylinder 508 carries gears 512 via respective gear shafts 513, which are situated radially inside lower gear ring 510. Gears 512 are rotated by the teeth of gear 516. As they rotate, they process around lower gear ring 510, which is held stationary, causing cylinder 508 to rotate. Gear 516 rotates drill bit 458. Drive cylinder 508 is adapted to engage and drive (rotate) sheath assembly 456 of drilling assembly 420.

An end 480 of drive cylinder 508 is adapted to frictionally engage a surface 461 of drive head 460. Surface 461 is formed of rubber or the like to facilitate frictional engagement with end 480. Thus, when end 480 is caused to rotate with drive cylinder 508, as described, end 480 engages surface 461 and sheath 457 rotates thereby effecting reaming the bore started by and/or being cut by drill bit 458. Thus, a bore is created that allows sheath 457 to extend therein. Thus, one mode of driving sheath assembly 420 is by friction via a friction plate or surface 461.

Drill bit handle 453 is affixed to drill bit 458 and is used to position the drill bit in the support cylinder 514 and lock it in place. Splines on the lower section of handle 453 are inserted into corresponding grooves in support cylinder 514 providing a radial interface the carries the rotational load from the drill bit to the support cylinder. Features on the handle 453 slide over and lock onto the 2 of the 4 tangs extending radially on the outside perimeter of the support cylinder 514 thus affixing drill bit 458 and drill bit handle 453 to support cylinder 514.

Cutting sheath 457 is, thus, not driven initially. It remains stationary to guide drill bit 458 when starting a hole. As drilling progresses, drive head 460 is frictionally engaged by drive cylinder 508 such that the sheath assembly is subsequently (after the start of drill bit rotation) rotated. This cuts a hole large enough for the sheath to follow the drill bit into the bone. To facilitate a robust frictional engagement between surface 461 and end 480, end 480 includes a plurality of notches 540 (Figure 22). The configuration of bone drill 410 can advantageously provide a one step bone access device that positions a user's hand a greater distance away from a radiation source employed with bone drill 410, thereby increasing safety and minimizing injury to the user.

As shown in Figure 20, handle portion 414 defines a longitudinal axis r. Drive portion 416 defines a longitudinal axis s, which is co-axial with a longitudinal axis t defined by head portion 418. Longitudinal axes s, t, and correspondingly drive portion 416 and head portion 418, are offset from longitudinal axis r, corresponding to handle portion 414. Longitudinal axes s, t are disposed at an angular orientation α relative to longitudinal axis r. It is contemplated that α is in a range of 0 to 45 degrees. It is further contemplated that α is most desirably 15 degrees. This advantageous configuration provides a safe distance between a physician and radiation emitted during a procedure employing bone drill 410.

Longitudinal axis s of drive portion 16 may also be separately offset and disposed at angular orientation α from longitudinal axis r of handle portion 14, relative to longitudinal axis t of head portion 18, such as longitudinal axis / being disposed at angular orientation α' and shown in phantom. Longitudinal axis 5 of drive portion 16 may be coaxial with longitudinal axis r of handle portion 14, and longitudinal axis / of head portion 18 may be offset from the drive/handle portions, or co-axial with one and offset from the other axis. It is contemplated that the various and multiple offset and angular relative configurations of handle portion 14, drive portion 16 and head portion 18 are provided via fixed fabrication of the component parts, pivoting components, ratcheting components, etc. and various combinations of the same. It is further contemplated that these attachments are assembled as is known to one skilled in the art.

In operation, a bone drill, similar to bone drill 10 and bone drill 410 described herein, is employed with a method for treating bone of a vertebral body or a sacral body. The components of bone drill 410, for example, are fabricated, properly sterilized and otherwise prepared for use. Bone drill 410 is provided with handle portion 414, drive portion 416 and head portion 418 in a configuration that provides a safe distance between a physician and radiation emitted during the procedure, as described above.

Head portion 418 includes radiolucent markers disposed in a configuration to facilitate alignment of sheath 457 with bone (not shown) of the vertebral body. During fluoroscopy, an area is exposed to radiation, which includes bone drill 410 and the bone of the vertebral body. The exposure of radiation to bone drill 410 and the radiolucent markers allows the user to identify the location of sheath 457 and drill bit 458 relative to the targeted bone. This configuration facilitates alignment, via the radiolucent markers, for cutting the bone while protecting the user by maintaining the offset angular orientation of bone drill 410, discussed above. A guard 710, discussed herein, may also be used during the procedure.

Drill bit 458 engages the bone and rotates via motor 498 to bore a cavity in the bone. Sheath 457 is driven into engagement with the bone to further define the cavity in the bone. After a cavity is created, according to the requirements of a particular treatment procedure, the targeted bone area is treated. In one embodiment, the step of treating includes treating vertebral compression fractures, which employs bone drill 410. Bone drill 410 allows the operator to place an access conduit/sheath/needle into a fractured vertebral body in a single step. Once the access conduit/sheath/needle is positioned in the fractured vertebral body, various devices including the bone curettes described can be inserted through the access conduit/sheath/needle into the bone. The bone curette, which has been configured to be inserted into the drill, creates a cavity in the fractured bone. Next, a bone cement mixture is instilled through the access conduit/sheath/needle. Cavity creation with the curette decreases the risk of cement leakage and also allows the placement of a greater cement volume.

In another embodiment, the step of treating includes treating sacral fractures, which employs bone drill 410. Bone drill 410 allows the operator to place an access conduit/sheath/needle into the fractured sacrum in a single step. Once the access conduit/sheath/needle is positioned in the fractured sacrum, various devices including the bone curettes described can be inserted through the access conduit/sheath/needle into the sacrum. The bone curette, which as been configured to be inserted into the drill, creates a cavity in the fractured bone. Next, a bone cement mixture is instilled through the access conduit/sheath/needle. Cavity creation with the curette decreases the risk of cement leakage anc also allows the placement of a greater cement volume.

In another embodiment, the step of treating includes treating lytic tumor deposits in the bone, which employs bone drill 410. Bone drill 410 allows the operator to place an accesi conduit/sheath/needle into the lytic bone tumor deposit in a single step. At that point a biopsy can be obtained. Once the access conduit/sheath/needle is positioned in the lytic tumor, various devices including the bone curettes described are configured to be inserted into the drill and can be inserted through the access conduit/sheath/needle into the tumor deposit. The curette can be used to create a cavity in the lytic tumor deposit. Next, a bone cement mixture is inserted through the access conduit/sheath/needle into the lytic tumor deposit. Cavity creation with the curette decreases the risk of cement leakage and also allows placement of a greater cement volume.

In another embodiment, the step of treating allows the operator to place an access conduit/sheath/needle into bone in order to obtain bone biopsy specimens or to obtain access foi bone infusions. In another embodiment, the step of treating includes bone drill 410, which can be used with different bits (such as various screwdriver bits) to facilitate/perform various surgical procedures requiring such tools that need to be used with fluoroscopic guidance.

In another embodiment, the step of treating may include the step of irrigating the cavity, suctioning the cavity and/or inflating the cavity with appropriate medical instrumentation as is known to one skilled in the art. A fluid-transfer device may be provided and used as a one-step device for simultaneously irrigating and aspirating material from the cavity. The fluid-transfer device may also be used for instilling bone cement into the cavity. The fluid-transfer device allows a greater and more uniform cement distribution by simultaneously instilling cement and aspirating the cavity. This configuration creates a preferred pathway that allows the cement to follow the path of least resistance resulting in more even cement distribution within the bone. Also, the step of treating may include various devices used for inflating the cavity.

Referring to Figures 29-31, an alternate embodiment of bone drill 410, similar to that described above, includes a guard 710. Guard 710 is configured to protect a user's hand from radiation. It is contemplated that guard 710 is integral to bone drill 410 or alternatively detachable. Guard 710 is designed to protect the user's hand from both primary beam and scatter radiation by centering inferiorly and laterally. Guard 710 may fabricated from flexible or rigid radio-protective materials, such as lead, tin, etc.

Bone drill 410 is relatively rotatable to guard 710 so that the user can rotate guard 710 to different positions, depending on the concentration of the primary beam and scatter radiation, and the origination of radiation. Guard 710 can be separate and permanently affixed to the bone drill 410. Alternatively, guard 710 could be snapped in place, slidably mounted in a flexible arrangement of thin shielding material such as lead, tin, etc., or in a boot, or sleeve, wrapped in a fabric such as nylon, etc., and mounted with Velcro fasteners in a configuration that allows the user to wrap it around the hand and drill 410.

Referring to Figures 32-34, an alternate embodiment of bone drill 410 is shown, which includes a sheath 810, similar to that described with regard to Figures 20-28. Sheath 810 has a proximal end including a drive head 812 and a distal end (not shown). Drive head 812 includes multiple projections on an outer periphery thereof. A drive cylinder 814 of head portion 418, similar to drive cylinder 508 described above, has an end 816, which includes openings 818. Openings 818 are configured to receive flexibly resilient projections 820 to mount sheath 810 with drive cylinder 814. As shown in Figure 33, tabs 822, mounted with drive head 812 and connected with projections 820, are manipulated inwardly such that the clasp portion of projection 820 can pass through opening 818. As drive head 812 engages end 816, tabs 822 are released such that sheath 810 is fixed with head portion 818 in a locking configuration. Such a locking configuration is releasable, and sheath 810 can be released from end 816 by depressing tab 822 so that the clasp portion of projections 820 can pass through and withdraw from opening 818. It is envisioned that sheath 810 may be permanently affixed to head portion 818, or integrally formed therewith. This snap configuration of sheath 810 facilitates continuous rotation with the drill bit and allows the user to flex projections 820 and detach sheath 810 from bone drill 410, once in a desired location during a procedure.

Referring to Figures 35-37, an alternate embodiment of bone drill 410 is shown, similar to that described above, which includes a head portion 910 and sheath 810, described above with regard to Figures 32-34.

Head portion 910 has a body 912 that defines an interior cavity 918 that supports the drilling assembly drive gearing. Motor assembly 498 is operatively coupled to an output shaft 501 , described above with regard to Figures 20-28, for rotation thereof via associated gearing. A bevel gear 502 is connected to output shaft 501 for meshing/engaging with the drilling assembly gearing in head portion 910. Bevel gear 502 meshes with an input gear 920 of the drilling assembly gearing. Input gear 920 is retained with a support cylinder 514 (see figure 28), which is connected to drill bit 458 through drill bit handle 914. Input gear 920 includes teeth on an outer radial periphery thereof that meshes with the teeth of bevel gear 502. A gear 924 is mounted with support cylinder 514 which is turn drives the planetary gear system used to rotate sheath 810 as described in the previous embodiment. Thus, as bevel gear 502 rotates input gear 920, input gear 920 rotates support cylinder 922 and gear 924, causing the planet gears 928 to rotate and process along the fixed lower gear ring 926.

Drive cylinder 814, described with regard to Figures 32-34, carries gears 928 via respective gear shafts 930 disposed radially inside lower gear ring 926. Gears 928 are rotated by the teeth of gear 924. Support cylinder 514 rotates drill bit 458 by coupling through drill bit handle 914. Drive cylinder 814 is mounted with drive head 812 of sheath 810, as described above with regard to Figures 32-34. Thus, when drive head 812 is caused to rotate with drive cylinder 814, as described, sheath 810 rotates thereby effecting reaming the bore started by and/or being cut by drill bit 458. A bore is created that allows sheath 810 to extend therein via a friction plate or surface 461 (Figure 23).

Input gear 920 has radially disposed cams 932 on an upper surface 934, which are correspondingly configured to engage radially disposed followers 936. Followers 936 are disposed on a lower surface 938 of an impact ram 940 / 922. Each cam 932 projecting from surface 934 has a constant slope to a crest or amplitude, and then a downward slope to a baseline, which begins the upward slope for the adjacent cam 932. Each follower 936, in a cooperative configuration with cams 932, has a constant downward slope to a baseline, which begins the downward slope for the adjacent follower 936.

A fixed rib 937 prevents rotation of impact ram 940 as input gear 920 rotates. Cams 932 and followers 936 are disposed in moveable engagement relative to each other. Input gear 920 may be rotated in both clockwise and counter-clockwise directions relative to ram 940. These alternative rotations are facilitated by the upward and downward slope portion on each of cams 932 and followers 936.

In operation, as input gear 920 rotates, cams 932 similarly rotate and engage followers 936. Such rotation and engagement cause followers 936 to displace about cams 932, causing impact ram 940 to move up and down according to the contact points of cam 932 and follower 936. As the crests or amplitude of the engaging cam 932 and follower 936 contact, ram 940 compresses a spring 942, mounted with support cylinder 922 of impact ram 940, within head portion 910, as shown in Figure 36.

Upon continued rotation past the crest contact point, the spring energy of spring 942 is released such that the force applied to spring 942 drives 940, as shown in Figure 37, which is connected to drill bit 458. Accordingly, drill bit 458 (Figure 21) is driven into bone during a procedure. The upward and downward slope for each of cams 932 and followers 936 are of a steep ascent/descent. This configuration facilitates a greater force or impact being applied to drill bit 458 in that the slope of the cam 932/follower 936 does not slow impact ram 940 travel as compared to a gradual slope. It is contemplated, however, that the slope or incline of cam 932/follower 936 may be variously angled according to the requirements of a particular procedure.

It is further contemplated that, alternative to the configuration of impact ram 940 discussed, impact ram 940 may be disposed 90 degrees from the drill bit axis and redirect the impact energy down and through the drill. It is envisioned that alternative to fixed rib 937, a sliding pin may be used. Such a configuration initiates and terminates the hammer / impact actions by retracting the pin back out of the slot in ram 940. This allows ram 940 to rotate with the bevel gear instead of being forced up against the spring pressure. When the pin is released, it will engage the slot in ram 940 causing it to cease rotation and begin repetitively moving axially against the spring pressure and releasing to impart impact energy into the drill bit.

Referring to Figures 38-45, an alternate embodiment of bone drill 410 is shown, similar to that described above, which includes a head portion 1510 and sheath 810, described above with regard to Figures 32-34. Bone drill 410 includes a forward/reverse switch 1511, which is connected to the power supply, the variable speed trigger switch, and the motor. It is contemplated that bone drill 410 may employ nine volt batteries as a power source, as shown in Figure 44. It is further contemplated that bone drill 410 may employ various battery or portable power arrangements, AC or DC power sources, etc. Head portion 1510 has a body 1512 that defines an interior cavity 1518, which supports the drilling assembly drive gearing. Motor assembly 498 is operatively coupled to an output shaft 501, described above with regard to Figures 20-28, for rotation thereof via associated gearing. A bevel gear 502 is connected to output shaft 501 for meshing/engaging with the drilling assembly gearing in head portion 1510.

Bevel gear 502 meshes with an input gear 1520 of the drilling assembly gearing. Input gear 1520 is retained with a sheath drive plate 1514 (see figure 45). The inner bore of sheath drive plate 1514 has axial spline grooves that slidably mate with drill bit lock 1515. Drill bit 458, with drill bit lock 1515, is inserted into the sheath drive plate, with the splines sliding in the grooves, until the groove on the end of the drill bit lock is captured by the spring wire catch 1564. The rotation of bevel gear 502 induces rotation in drill bit 458 through sheath drive plate 1514 and drill bit lock 1515. After locking the drill bit in place, sheath 810 is inserted over drill bit 458 until it locks onto sheath drive plate 1514 by two locking tabs 1517. In this particular embodiment, the sheath and the drill bit rotate at the same speed.

Input gear 1520 has radially disposed cams, which are correspondingly configured to engage radially disposed followers of an impact ram 1540, similar to input gear 920 and impact ram 940 described above with regard to Figures 35-37 and operate in a similar manner.

Impact ram 1540 rotates with input gear 1520. Alternatively, an impact switch 1570 is moved to provide a stop for impact ram 1540 to stop rotation and cause impact ram 1540 to move up and down. Impact ram 1540 includes a ram weight 1523 to increase impact force. Ram weight 1523 has 3 holes configured for supporting compression springs that provides return force.

A knob 1542 extends laterally from body 1512 via a shaft 1544. Knob 1542 is configured to facilitate remote manipulation of a knob 1546 from a distance that allows the users hands to remain away from the radiation beam while adjusting the sheath extension. Knob 1542 is knurled to facilitate manipulation thereof. Rotating knob 1546 directly or remotely using knob 1542, causes the components of drill bit 458 to extend or retract relative to sheath 810 for creating a cavity in targeted bone. Shaft 1544 includes an output shaft 1548, mounted with a bevel gear 1550, which translates rotation of knob 1542 and shaft 1544 to the gearing of body 1512. Bevel gear 1550 meshes with an input gear 1552 of the gearing of body 1512. Input gear 1552 is mated to knob 1546 through the upper housing of body 1512. Input gear 1552 includes teeth radially disposed thereabout that mesh with teeth of bevel gear 1550. As bevel gear 1550 rotates, as caused by rotation of shaft 1544 described above, input gear 1552 is caused to rotate, which in turn rotates knob 1546.

Knob 1546 is knurled to facilitate manipulation thereof. Knob 1546 is disposed for extension and retraction of the components of drill bit 458. Knob 1546 is slidably mounted to push rod 1554. As knob 1546 rotates, a shuttle 1556 rotates, via splines that threadably engage input gear 1552. The sliding splines allow the shuttle 1556 to translate axially relative to gear 1552 as it rotates. Shuttle 1556 is fixed in position along the drive axis of body 1512 by guide balls 1558 that ride in helical grooves 1560 of shuttle 1556. Guide balls 1558 are fixed in position with recesses 1562 of housing 1512. Thus, rotation of shuttle 1556 causes shuttle 1556 to translate up or down due to the threaded engagement of helical grooves 1560 with the fixed guide balls 1558.

Shuttle 1556 locks the proximal end of drill bit lock 1515 via a spring wire form 1564 that springs out and then back into a groove on the proximal end of drill bit 1515. To remove drill bit 1515, drill bit 1515is retracted completely so that push rod 1554 engages spring wire form 1564. An eject button 1566, connected to push rod 1554, is depressed such that push rod 1554 engages and spring wire form 1564 opens, releasing the proximal end of drill bit 1515.

A slide 1568 translates impact energy from impact ram 1540 to shuttlel556. Slide 1568 translates the impact energy through guide balls 1558. As impact ram 1540 moves downward, impact ram 1540 engages the flange on slide 1568. Slide 1568 moves downward, pulling guide balls 1558 in the same direction. Guide balls 1558 in turn cause shuttle 1556 to move downward, transferring the impact energy through drill bit 1515 into the bone. If impact switch 1570 is slid vertically toward knob 1546, it removes the rotational stop from impact ram 1540 allowing it to preferentially rotate with bevel gear 502 instead of translating axially against the spring forces. This stops the impact function allowing pure rotation of the drill bit. An alternate embodiment for a body of a bone drill fashioned in accordance with the present principles separates the handle portion from the drive or motor portion. Thus, the drive portion would extend from one radial side of the head portion while the handle portion would extend from another radial side of the head portion, preferably, but not necessarily at 180° therefrom to provide a balance in weight about the drill bit or weight distribution relative to the drill bit. This reduces any torque or moments that cause twisting and thus possible bone damage.

Referring to Figure 46, there is illustrated a cavity drill 610 configured for use with bone drill 410, similar to that described above with regard to Figures 20-45, in accordance with the principles of the present disclosure. It is envisioned that cavity drill 610 may be employed with other bone drills described.

Cavity drill 610 and bone drill 410 are adapted to bore a hole into bone such as, for example, into a vertebra or vertebral body during a vertebroplasty procedure and under fluoroscopy. As such, various components, as desired, of cavity drill 610 and bone drill 410, are formed of a radio translucent (radiolucent) material. Thus, only those components that are not radiolucent will show up under x-ray and/or during real time fluoroscopy. It should be appreciated that bone drill 410 including cavity drill 610 is adapted to perform various surgical drilling procedures other than for a vertebroplasty procedure.

In one form, bone drill 410 is adapted to create or drill a bore in bone of a vertebral oi sacral body, and to introduce and temporarily leave a tube, tubular sheath or the like in the bore. A tubular sheath of the bone drill assembly is configured to allow an instrument, component, tool or the like to pass therethrough and provide access to an area at or adjacent to the distal end oJ the tubular sheath.

In operation, a bone drill having a cavity drill, similar to those described herein, is employed with a method for treating bone of a vertebral body or a sacral body, such as those described herein.

Referring to Figures 46-53, cavity drill 610 includes a body 612, a sheath 614 and t handle 616. It is also envisioned that cavity drill 610, or components thereof, are disposable after a vertebral body or sacral body procedure. Cavity drill 610 and its components may also be reused.

Cavity drill 610 is assembled by removing a drill bit handle and a sheath of bone drill 410, and attaching cavity drill 610 thereafter. The cavity drill may then be inserted through the access sheath/conduit/tube previously placed by the off-angle bone drill to reach the affected bone area. Body 612 mounts to head 418 via tabs 618, which are snapped or inserted with corresponding slots of head 418. Upon attachment, sheath 614 extends through a support cylinder of bone drill 410. Cavity drill 610 is mounted for rotation relative to head 418.

The cavity drill is powered by the drill motor of bone drill 410. The act of mounting cavity drill 610 to the head 418 connects the drive mechanism within head 418 to the sheath 614 through a spline type interface. Activating the drill motor causes the sheath 614 to rotate which in turn rotates the cutter 622. As the cutter is rotating, the blades 642 stored within the cutter 622 can be extended or retracted as desired to cut the desired cavity diameter.

Handle 616 extends laterally from body 612 to a knob 620. Handle 616 is configured to facilitate remote manipulation of knob 632 from a distance that allows the users hands to remain away from the radiation beam while adjusting the cutter extension. Knob 620 is knurled to facilitate manipulation thereof. Rotating knob 632 directly or remotely using knob 620, causes the cutter blades to extend or retract thereby defining the size of the cavity being cut for creating and/or enlarging a cavity in targeted bone.

Referring to Figure 51, handle 616 includes an output shaft 624, mounted with a bevel gear 626, which translates rotation of handle 616 to the gearing of body 612. Bevel gear 626 meshes with an input gear 638 of the gearing of body 612. Input gear 638 is mated to knob 632 through the upper housing of body 612. Input gear 638 includes teeth radially disposed thereabout that mesh with teeth of bevel gear 626. As bevel gear 626 rotates, as caused by rotation of handle 616 described above, input gear 638 is caused to rotate, which in turn rotates knob 632. Knob 632 is knurled to facilitate manipulation thereof. Knob 632 is disposed for extension and retraction of cutter blades 642 of bone curette 622. Knob 632 is slidably mounted to push rod 615 through a male gear 634, which mates with a female gear 636 of support cylinder 630. Male gear 634 and female gear 636 are correspondingly threaded for reciprocal rotation and relative axial movement. As knob 632 is manipulated for rotation, male gear 634 threadably engages with female gear 636. The reciprocal rotation of gears 634, 636 causes relative axial translation of male gear 634 and thus push rod 615 inside of sheath 614, which freely rotates within a cavity 640 of gear 634. This configuration advantageously facilitates driving of cutter blades 642 within bone curette 622 into the targeted bone for a procedure. For example, as shown in Figure 51, push rod 615 is in a retracted position. Knob 632 is rotated to cause axial movement of push rod 615 to an extended position as described, as shown in Figure 52.

Bone curette 622 includes blades 642, as shown in Figure 48. Blades 642 have a wide, thin design to facilitate cutting of the targeted bone. Blades 642 rotate to cut the targeted bone. Rotation is controlled and powered by motor 498. Blades 642 are advanced and retracted by manipulating knob 632, as described above. Blades 642 are flexible in one direction, allowing them to deflect out of the holding position at an angle as they extend. The length of extension and the deflection angle define the diameter of the cutting action. The blades are wider and thereby stiffer / stronger in the circumferential direction to facilitate cutting of the bone without deflection. The ends of the blades may have a plurality of different cutting edges defined as desired. Blades 642 may have radio-opaque markers to facilitate alignment of cavity drill 610 and visual determination of cavity size / length being created.

As shown in Figure 54, curette 622 includes a tubular body/pusher/cutter 644 within the outer tube 614, and an end cap 648. The other end (not shown) of outer tube 614 includes a plastic molded handle with snapping features to lock and release from bone drill 410. Inside outer tube 614 is pusher/cutting tube 644 having its end cut as shown to create a plurality (four, 4) cutting tines, blades or the like, 642a, 642b, 642c, and 642d. An end cap 648 having conical body 654 and a ball top 650, has four slots or openings 652a, 652b, 652c, and 652d. It is rigidly affixed to the distal end of outer tube 614. The four tines 642a, 642b, 642c,and 642d line up with slots 652a, 652b, 652c, and 652d. The four (4) holes or openings 652a, 652b, 652c, and 652d allow curette blades 642 to be pushed out from outer tube 614 through holes 652. Pusher 644 controls the extension of curette blades 642. Configured guides 656a, 656b, 656c, and 656d of end cap 648 aid in directing blades 642. The tubular shaft assembly is inserted into bone drill 410 with the bone drill causing the blades to turn and create/enlarge a cavity in the targeted bone. It is contemplated that the bone drill 410 may have a variable speed control and may also have a control allowing forward/reverse rotation.

The other end of tube 614, extending from the handle of the outer tube, is molded to interface with the outer tube handle in such a way to allow the user to force inner tube/cutter 644 toward distal end 643 of outer tube 614. As the inner tube is forced distally (axially), tines 642 slide through grooves 652 of tip 650 of end cap 648 and out of outer tube 614 directed by the shape of the slots to project tines 642 in the radial direction. The ends of the tines act as cutting edges to create a cavity.

The user extends tines 642 a short distance (see, e.g. Figure 56), turns on bone drill 410 and then moves the drill axially through the sheath to enlarge the cavity. As the tines are moved outward (see, e.g. Figure 57), the drill is moved axially again to enlarge the cavity (see, e.g. Figure 58) until the cavity is the desired size. The ends of tines 642 may be flat, as shown, or other shapes. Tines 642 are thin in the dimension that is forced to bend by the slots and wider in the dimension that resists deflection during the cutting action. Nitinol may be used as the tine material.

As represented by the double-headed arrows shown in Figure 54, cutting tube 644 is axially movable relative to tube 614. In this manner, through axial adjustment of cutting tube 644 relative to tube 614, the length of the cutting blades that extend from slots or openings 652a, 652b, 652c, and 652d in the tip 650 of end cap 648 are adjusted and/or controlled. Moreover, in this manner, through radial movement or rotation of outer tube 614 it causes radial movement or rotation of cutting tube 644, cutting tines 642 are radially rotated to cut as desired. Sides and tips of tines 642 are shaped to provide edges or blades as appropriate. These may also include serrations. The serrations may comprise one or more configurations as appropriate for the material to be cut.

Figure 55 shows curette 622 with four cutting tines 642a, 642b, 642c, and 642d fully retracted into tip 650/tube 614. In this position, curette 622 may be fed through the sheath 56. Figure 56 shows curette 622 with four cutting tines 642a, 642b, 642c, and 642d in a minimally extended position from tip 650/tube 614. In this position, blades 642a, 642b, 642c, and 642d cut a minimal diameter swath during rotation thereof.

Figure 57 shows curette 622 with four cutting tines 642a, 642b, 642c, and 642d in an intermediately extended position from tip 650. In this position, blades 642a, 642b, 642c, and 642d cut an intermediate diameter swath.

Figure 58 shows curette 622 with four cutting tines 642a, 642b, 642c, and 642d fully extended from tip 650. In this position, a maximum cutting diameter (maximum diameter swath) is achieved during rotation of cutting tube 614/tip650. It should be appreciated that blades 642a, 642b, 642c, and 642d are continuously extendable from the position shown in Figure 55 through the position of Figure 58.

Bone drill 410, including cavity drill 610, may include a guard configured to protect a user's hand from radiation. It is contemplated that the guard can be integral to bone drill 410 or alternatively detachable.

Referring to Figures 59-66, in an alternate embodiment, bone drill 410 includes a cavity drill 1010, similar to cavity drill 610 described above. Cavity drill 1010 includes a body 1012, a sheath 1014 and a handle 1016. Cavity drill 1010 is assembled by removing the drill bit handle and the sheath 457 of bone drill 410 and attaching cavity drill 1010 thereafter. Body 1012 mounts to head 418 via tabs 1018, which are snapped or inserted with corresponding slots of head 418. Upon attachment, sheath 1014 extends through the support of bone drill 410. Cavity drill 1010 is mounted for rotation relative to head 418. Handle 1016 extends laterally from body 1012 to a knob 1020.

Cavity drill 1010 is similar to cavity drill 610 with respect to the cutter blades being extended and retracted through manipulation of knob 1032 directly, or knob 1020 remotely using the same bevel gear set, male and female internal gears, and the support cylinder. The difference described in this embodiment relates to the method for rotating sheath 1014. For example, sheath 614 in the previous embodiment rotated continuously in one direction or the other, this embodiment creates an oscillation motion through a defined arc for a cutter assembly 1022 that has only one cutter blade. This allows the formation of an asymmetric cavity. As the rotating blades sweep out a cavity defined by the arc of the oscillation, the entire drill assembly can be rotated around to effectively increase the described arc as desired to create an asymmetric cavity as needed.

A motor assembly and output shaft for bone drill 410 is operatively coupled to a gearing assembly of cavity drill 1010 to cause an oscillating rotation of shaft 1014. The gearing assembly is operatively coupled to output shaft 1014 for rotation thereof to perform a cavity creation procedure, similar to those described herein. The gearing assembly of cavity drill 1010 is disposed with body 1012 and includes a wheel gear 1042 operatively coupled to support cylinder 514 (defined previously). This configuration translates rotation of the motor / gearhead assembly through the support cylinder to rotation of wheel gear 1042.

Wheel gear 1042 engages/meshes with a pinion gear 1044 causing corresponding rotation thereof. A cylinder 1046 is mounted with pinion gear 1044 and simultaneously rotates therewith. A connecting link 1048 is mounted to cylinder 1046 and drive link 1054. Connecting link 1048 has a first end 1050 attached to cylinder 1046 and a second end 1052 attached to drive link 1054 which is mounted about output shaft 1014. This configuration advantageously provides an asymmetric volume center around output shaft 1014, which oscillates bone curette 1022 back and forth as an alternative to rotating continuously in one direction.

As shown in Figure 63, second end 1052 is in a downward position, relative to the perspective view of the Figure. As cylinder 1046 is caused to rotate, as discussed above, in foi example, a counter clockwise direction, first end 1050 rotates about the center of pinion geai 1046. Rotation of first end 1050 translates motion of link 1048, which causes second end 1052 to move from the downward position to an upward position, as shown by arrow A in Figure 65.

As first end 1050 continues in a counter-clockwise direction about the center of piniof gear 1046, motion of link 1048 causes second end 1052 to move from the upward position to the downward position, as shown by arrow B in Figure 64. This advantageous design converts th. continuous rotation of the output shaft and motor assembly of bone drill 410, to an oscillating motion of bone curette 1022 during a cavity creation procedure. By eliminating all but one o: the cutting blades, this design can now cut an asymmetric volume in the vertebral body. The user would extend the single blade and excise a defined arc, for example, about 60 degrees. The user then rotates bone drill 410 (or possibly the cavity drill body only) to excise a different area around output shaft 1014. This design is useful, for example, if the access hole into a vertebral body is too close to an outside wall or a top / bottom plate.

Referring to Figures 67-74, an alternate embodiment of bone drill 410 is shown, similar to that described above, which includes a head portion 1510 and a cavity drill assembly 1610, similar to cavity drill 610 described above and alternatively mounted to bone drill 410, for creating and/or enlarging a cavity in targeted bone. Bone drill 410 includes a forward/reverse switch 1511, which is connected to the power supply , the variable speed trigger switch, and the motor. It is contemplated that bone drill 410 may employ nine volt batteries as a power source, as shown in Figure 68. It is further contemplated that bone drill 410 may employ various battery or portable power arrangements, AC or DC power sources, etc.

Head portion 1510 has a body 1512 that defines an interior cavity 1518, which supports the cavity drill assembly drive gearing. A motor assembly 498 is operatively coupled to an output shaft 501 for rotation thereof via associated gearing, such as that described above with regard to Figures 20-45. A bevel gear 502 is connected to output shaft 501 for meshing/engaging with the cavity drill assembly gearing in head portion 1510.

Bevel gear 502 meshes with an input gear 1520 of the cavity drill assembly gearing. Input gear 1520 is retained with a sheath drive plate 1514 which is connected to cavity drill assembly 1610, as will be described.

Input gear 1520 has radially disposed cams, which are correspondingly configured to engage radially disposed followers of an impact ram 1540, to translate impact energy to targeted bone for creating and/or enlarging a cavity, similar to that described with regard to Figures 38-45 above.

Impact ram 1540 rotates with input gear 1520. Alternatively, an impact switch 1521 is moved to provide a stop for impact ram 1540 to stop rotation and cause impact ram 1540 to move up and down. Impact ram 1540 includes a ram weight 1523 to increase impact force. Ram weight 1523 has 3 holes configured for supporting compression springs that provide return force. A knob 1542 extends laterally from body 1512 via a shaft 1544. Knob 1542 is configured to facilitate remote manipulation of a knob 1546 from a distance that allows a user's hands to remain away from the radiation beam while adjusting the sheath extension. Knob 1542 is knurled to facilitate manipulation thereof. Rotating knob 1546 directly, or remotely using knob 1542, causes the components of cavity drill assembly 1610 to extend or retract for creating and/or enlarging a cavity in targeted bone.

Shaft 1544 includes an output shaft 1548, mounted with a bevel gear 1550, which translates rotation of knob 1542 and shaft 1544 to the gearing of body 1512. Bevel gear 1550 meshes with an input gear 1552 of the gearing of body 1512. Input gear 1552 is mated to knob 1546 through the upper housing of body 1512. Input gear 1552 includes teeth radially disposed thereabout that mesh with teeth of bevel gear 1550. As bevel gear 1550 rotates, as caused by rotation of shaft 1544 described above, input gear 1552 is caused to rotate, which in turn rotates knob 1546.

Knob 1546 is knurled to facilitate manipulation thereof. Knob 1546 is disposed for extension and retraction of the components of cavity drill assembly 1610, Knob 1546 is slidably mounted to push rod 1554. As knob 1546 rotates, a shuttle 1556 rotates, via splines that threadably engage input gear 1552. The sliding splines allow the shuttle 1556 to translate axially relative to gear 1552 as it rotates. Shuttle 1556 is fixed in position along the drive axis of body 1512 by guide balls 1558 that ride in helical grooves 1560 of shuttle 1556. Guide balls 1558 are fixed in position with recesses 1562 of housing 1512. Thus, rotation of shuttle 1556 causes shuttle 1556 to translate up or down due to the threaded engagement of helical grooves 1560 with the fixed guide balls 1558.

Shuttle 1556 locks the proximal end of cavity drill assembly 1610 via a spring wire form 1564 that springs out and then back into a groove on the proximal end of cavity drill assembly 1610. To remove cavity drill assembly 1610, cavity drill assembly 1610 is retracted completely so that push rod 1554 engages spring wire form 1564. An eject button 1566, connected to push rod 1554, is depressed such that push rod 1554 engages and spring wire form 1564 opens, releasing the proximal end of cavity drill assembly 1610.

A slide 1568 translates impact energy from impact ram 1540 to shuttle 1556. Slide 1565 translates the impact energy through guide balls 1558. As impact ram 1540 moves downward, impact ram 1540 engages the flange on slide 1568. Slide 1568 moves downward, pulling guide balls 1558 in the same direction. Guide balls 1558 in turn cause shuttle 1556 to move downward, transferring the impact energy through cavity drill assembly 1610 into the bone.

Cavity drill assembly 1610 includes a body 1612, a sheath 1614 and a flange 1616. Flange 1616 mounts to head portion 1510 via tabs 1617, which are snapped or inserted with corresponding slots of sheath drive plate 1514.

Cavity drill assembly 1610 is powered by motor assembly 498. Activating the motor causes sheath 1614 to rotate, which in turn rotates bone curette 1622, similar to bone curette 622 described above. As bone curette 1622 rotates, blades 1642, stored therewith, rotate and can be extended and retracted for creating and/or enlarging a cavity in targeted bone. Blades 1642 are extended and retracted through the rotation of knob 1546, which causes translation of the shuttle 1556 thereby causing translation of a push rod inside sheath 1614 relative to sheath 1614 forcing the blades out through the openings in the tip, as in the previous embodiment.

In an alternate embodiment, a vertebral treatment device and methods of use disclosed are discussed in terms of medical apparatus and more particularly, in terms of vertebral treatment devices, bone drills, bone drill assemblies and bone cavity drills that can be employed for treating vertebral body and sacral fractures. The vertebral treatment devices may also be employed to treat lytic tumor deposits in bone.

Referring to FIG. 75, a vertebral treatment device, such as, for example, a forceps 1300 is provided, in accordance with the principles of the present disclosure. The components of forceps 1300 are fabricated from materials suitable for medical applications, such as, for example, polymeries and/or metals, depending on the particular application and/or preference. These materials may be radiolucent. Semi-rigid and rigid polymeries are contemplated for fabrication, as well as resilient materials, such as molded medical grade polyurethane, etc. It is contemplated that any motors, gearing, electronics and power components employed with forceps 1300 may be fabricated from those suitable for a medical application. Forceps 1300 may also include circuit boards, circuitry, processor components, etc. for computerized control. One skilled in the art, however, will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate.

Referring to Figures 75-78, forceps 1300 is configured for use with a bone drill such as, for example, those bone drills described above. Forceps 1300 is adapted to stabilize and guide a shaft, sheath and/or drill bit of a bone drill during treatment of a vertebral body, as will be described. Forceps 1300 is radiolucent such that at least a portion thereof is formed of a radiolucent material. It is contemplated that various components of forceps 1300 may be formed by radiolucent material and/or radioopaque material.

Forceps 1300 has a handle 1302 configured for grasping by a user's hand. A radiation protection guard may be attached to the handle. This guard may be fabricated from flexible or rigid radio-protective materials such as lead, tin, etc. The guard may be rotatable and/or removable. Handle 1302 has an actuator 1304, which is pivotably connected therewith. Actuator 1304 is manipulable inward towards handle 1302, in the direction shown by arrow D in Figures 75 and 76, by having a user's hand grasp or squeeze actuator 1304 with handle 1302. Actuator 1304 is manipulable outwardly away from handle 1302 by having a user's finger drive or push actuator 1304 at finger portion 1306, in the direction shown by arrow E.

A shaft 1308 extends from handle 1302 from a first end 1310 slidably mounted therewith to a second end 1312. Shaft 1308 has a tubular configuration to support an elongated member 1314. It is contemplated that shaft 1308 may be variously configured and dimensioned, for example, the length of shaft 1308 may be extended to protect the user from radiation. It is further contemplated that shaft 1308 may have various cross sectional configurations such as rectangular, elliptical, etc. It is envisioned that shaft 1308 may be fabricated from radiolucent material, as well as other components of forceps 1300, or alternatively, only shaft 1308 is fabricated from radiolucent material.

Elongated member 1314 extends through shaft 1308 and has a proximal end 1316 and a distal end 1318. Elongated member 1314 is fixed relative to handle 1302 at proximal end 1316. Distal end 1318 includes opposing arms 1324, 1326, which are configured to grasp. Shaft 1308 slides relative to handle 1302 and elongated member 1314. Proximal end 1310 is operatively engageable with actuator 1304. Actuator 1304 includes a tab 1320 configured for disposal within an opening 1322 defined in the proximal end 1310. It is envisioned that elongated member 1314 may be fabricated from radiolucent material, as well as other components of forceps 1300, or alternatively, only elongated member 1314 is fabricated from radiolucent material.

Tab 1320 engages a proximal end of opening 1322 to drive shaft 1308 in a proximal direction relative to elongated member 1314, in the direction shown by arrow F in Figure 3. Tab 1320 engages a distal end of opening 1322 to drive shaft 1308 in a distal direction relative to elongated member 1314, in the direction shown by arrow G. A user manipulates actuator 1304 with handle 1302, as described to cause axial movement of shaft 1308 relative to elongated member 1314.

When shaft 1308 is forced distally (direction arrow G) it pushes on the angled sides of arms 1324, 1326 of jaws 1328, 1329 forcing them together thereby gripping whatever shaft is positioned within the jaws. A spring mounted within the cylindrical cavity of handle 1302 whose proximal side pushes against the inside wall of said cavity and whose distal end presses against the proximal end 1310 of shaft 1308 biases shaft 1308 distally applying a slight closing pressure on arms 1324, 1326. This allows the jaws to snap open and then closed around a shaft that is forced into the distal ends of jaws 1328, 1329. It is envisioned that arms 1324, 1326 and/or jaws 1328, 1329 may be fabricated from radiolucent material, as well as other components of forceps 1300, or alternatively, only arms 1324, 1326 and/or jaws 1328, 1329 are fabricated from radiolucent material.

Shaft 1308 is axially moveable between a retracted position whereby arms 1324, 1326, which include jaws 1328, 1329 and define a cylindrical cavity 1330, are in a substantially open position, and an extended position whereby arms 1324, 1326 are in a substantially closed position.

Opposing arms 1324, 1326 are pivotably connected at distal end 1318 by hinge 1332. Jaws 1328, 1329 may be biased outwardly by a resilient hinge connection of arms 1324, 1326 at hinge 1332. It is contemplated that arms 1324, 1326 may be biased via a spring, elastics, etc. It is further contemplated that arms 1324, 1326 may be manually moveable or moveable through mechanical advantage via the engagement of the components of forceps 1300. In the retracted position, shaft 1308 is in its proximal most position relative to elongated member 1314. Actuator 1304 is in its forward most position with tabs 1320 engaging the proximal end of opening 1322. Arms 1324, 1326 are extended from shaft 1308 and jaws 1328, 1329 are in the open position.

To grasp an object, such as a shaft, sheath, drill bit, etc., the user grasps handle 1302 and engages finger portion 1306 to drive it forward, in the direction shown by arrow E. This causes tab 1320 to drive shaft 1308 rearwardly such that arms 1324, 1326 are extended from shaft 1308 in an open position allowing the jaws to slide over the object that is to be grasped. As the user then squeezes actuator 1304 and handle 1302, tab 1320 moves axially to engage the distal end of opening 1322. Shaft 1308 is driven forward to the extended position. This causes arms 1324, 1326 to be forced together into the closed position. The inner wall of the shaft 1308 engages arms 1324, 1326, overcoming their outward bias, and drawing jaws 1328, 1329 together to the closed position to grasp an object. Cylindrical cavity 1330 is configured to fit with the object being grasped. This advantageous configuration of forceps 1300 facilitates guidance and stabilizes various instruments that may be employed during a vertebral treatment procedure. It is envisioned that jaws 1328, 1329 may define a cylindrical cavity having alternate configurations such as elliptical, transverse, polygonal, etc.

In another particular embodiment, in accordance with the principles of the present disclosure, a vertebral treatment system is provided. The vertebral treatment system includes components such as a bone drill, forceps and a cavity drill for treating fractured bone of a vertebral body and/or a sacral body. It is envisioned that the vertebral treatment system may include one or all of the components discussed herein. It is further envisioned that the vertebral treatment system may include other components applicable to a vertebral treatment procedure and in accordance with the present disclosure.

The vertebral treatment system employs, for example, a bone drill 410, as shown in Figure 79 and described above with regard to Figures 20-45, and a cavity drill 610, as shown in Figure 80 and described above with regard to Figures 46-74. It is envisioned that the vertebral treatment system may employ alternative components. Other uses of the described components of the vertebral treatment system are also contemplated. In operation of the vertebral treatment system, bone drill 410 is employed with a method for treating fractured bone of a vertebral body or a sacral body. The components of bone drill 410 are fabricated, properly sterilized and otherwise prepared for use. Bone drill 410 is provided with handle portion 414, drive portion 416 and head portion 418 in a configuration that provides a safe distance between a physician and radiation emitted during the procedure.

Head portion 418 includes radioopaque markers 464 disposed in a configuration to facilitate alignment of sheath 457 with bone of the vertebral body. During fluoroscopy, an area is exposed to radiation, which includes bone drill 410 and the bone of the vertebral body. The exposure of radiation to bone drill 410 and radioopaque markers 464 allows the user to identify the location of sheath 457 and drill bit 458 relative to the targeted bone. This configuration facilitates alignment, via radioopaque markers 464, for cutting the bone while protecting the user by maintaining the offset angular orientation of bone drill 410. A guard 710 may also be used during the procedure.

Forceps 1300 is provided to stabilize and guide bone drill 410 during drilling of bone of the vertebral body. Forceps 1300 includes radiolucent arms 1324, 1326 having jaws 1328, 1329. This allows the user to see drill bit 458 and sheath 457, which are radioopaque, and the underlying bone structures. This configuration facilitates guidance for drilling and protects the user from radiation by maintaining the hands of the user a safe distance therefrom.

Arms 1324, 1326 are moveable between a closed position and an open position, as discussed above. When jaws 1328, 1329 are in the open position, sheath 457 is free to rotate. To grasp sheath 457 for guidance and stabilization of bone drill 410 during the vertebral drilling procedure, the user grasps handle 1302 and squeezes on actuator 1304. Shaft 1308 moves to the extended position and jaws 1328, 1329 move to the closed position to grasp sheath 457. Cylindrical cavity 1330 is configured to snugly fit and snap onto sheath 457. Sheath 457 is firmly held in position by forceps 1300, which advantageously operates as a drill guide.

Drill bit 458 engages the bone and rotates via motor 498 to bore a cavity in the bone. Sheath 457 is driven into engagement with the bone to further define the cavity in the bone. After drill bit 458 has reached a desired depth within the targeted bone, according to the requirements of a particular procedure, actuator 1304 of forceps 1300 can release jaws 1328, 1329 from sheath 457. Sheath 457 is free to rotate. If desired, forceps 1300 may be removed from sheath 457.

Cavity drill 610, which is an alternate embodiment of bone drill 410, is provided for enlarging and/or further defining the cavity bored in the bone by bone drill 410. Cavity drill 610 includes a knob 620, which is manipulated for rotation to drive a bone curette 622, which reams the targeted bone and cavity. Cavity drill 610 also includes a knob 632, which is manipulated for rotation to cause relative axial translation of bone curette 622. Knobs 620, 632 are rotated, in cooperation to ream the targeted bone area and further define the targeted bone cavity. It is contemplated that cavity drill 610 may include radioopaque markers to facilitate alignment thereof with the targeted bone. A radiation protection guard 710 may be fabricated from flexible or rigid radio-protective materials such as lead, tin, etc.; the guard may be rotatable and/or removable.

After the cavity is created in the targeted vertebral bone, according to the requirements for the particular fracture and treatment procedure, the targeted vertebral body or sacral body is treated. See, for example, the description of the methods of use described above. It is contemplated that one or a plurality of cavities may be created to allow for access tubing, cannulas, etc. in the targeted area. It is further contemplated that balloon catheters, etc., may be inserted through the access tubing, cannulas, etc. into the targeted fractured vertebral body. It is envisioned that the access tubing, cannulas, etc. may be fabricated from radiolucent material and/or radioopaque material. It is contemplated that bone cement may be instilled through the access tubing, cannulas, etc. into the targeted bone.

Referring to FIG. 81, there is illustrated a vertebral treatment device, such as, for example, a fluid transfer device 1200, in accordance with the principles of the present disclosure.

The components of fluid transfer device 1200 are fabricated from materials suitable for medical applications, such as, for example, polymeries and/or metals, depending on the particular application and/or preference. Semi-rigid and rigid polymeries are contemplated for fabrication, as well as resilient materials, such as molded medical grade polyurethane, etc. It is contemplated that any motors, gearing, electronics and power components employed with fluid transfer device 1200 may be fabricated from those suitable for a medical application. Fluid transfer device 1200 may also include circuit boards, circuitry, processor components, etc. for computerized control. One skilled in the art, however, will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate.

Referring to Figures 81-86, fluid transfer device 1200 is adapted for treating vertebral and sacral fractures to facilitate, for example, instilling orthopedic bone filler/cement into fractured bone. Various components, as desired, of fluid transfer device 1200 may be formed of a radio translucent (radiolucent) material and/or radioopaque material. Fluid transfer device 1200 is adapted to treat a vertebral body having a vertebral cavity, as will be discussed. It is envisioned that fluid transfer device 1200, or components thereof are disposable after a vertebral body or sacral body procedure. Fluid transfer device 1200 and its components may also be reused.

Fluid transfer device 1200 has a body 1202. Body 1202 includes a first section 1204, a second section 1206 and a handle 1208. First section 1204 and second section 1206 are integrally assembled to support components of fluid transfer device 1200. It is contemplated that first section 1204 and second section 1206 may be adhered as a unit, retained by mechanical structure such as, clips, pins, etc., or by other methods known to one skilled in the art. Portions of body 1202 may be monolithically formed. It is further contemplated that sections 1204, 1206 may be symmetric halves, offset, non-symmetric, etc.

Handle 1208 is connected with second section 1206 and facilitates grasping/manipulation of fluid transfer device 1200 by a user. Handle 1208 has a tubular body 1210, which is configured for a user's hand to wrap around. It is envisioned that tubular body 1210 may include a finger grip area. Tubular body 1210 may also be pivotable relative to body 1202 to facilitate manipulation and use of fluid transfer device 1200 for a particular application, as well as protecting a user from radiation during fluoroscopy.

Body 1202 supports a first cylinder, such as, for example, syringe 1212 and a second cylinder, such as, for example, syringe 1214. Syringe 1212 defines a first cavity 1216 and supports a first plunger 1218. First plunger 1218 is disposed for axial movement within first cavity 1216 in a configuration such that a first fluid, such as, for example, body fluid, including blood and/or bone fragments, is drawn into first cavity 1216 from a vertebral cavity of a vertebral body (Figure 90).

Syringe 1212 has a tubular body 1220 that extends from a first end 1222 to a second end 1224. First end 1222 includes a flange 1226, which is releasably mounted with body 1202 via brackets 1228. Flange 1226 has tabs 1230 that can be rotated into and out of position with brackets 1228 for retaining and releasing syringe 1212 from body 1202. It is contemplated that syringe 1212 may also be releasably mounted with body 1202 by other structure such as a spring mechanism, insertion with body 1202, clips, threaded engagement, luer lock, etc. It is further contemplated that syringe 1212 may be permanently fixed with body 1202 via adhesive, locking assembly, monolithically formed components, etc. It is envisioned that tubular body 1220 may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative cross section such as elliptical, polygonal, etc.

Second end 1224 has a nozzle 1232 configured to receive the body fluid being drawn from the vertebral cavity. Nozzle 1232 is connected to an access tube or the like, discussed below, which is a conduit for the drawn body fluid. It is contemplated that nozzle 1232 and its opening may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative opening sizes to regulate fluid flow.

Syringe 1214 defines a second cavity 1234 and supports a second plunger 1236. Second plunger 1236 is disposed for axial movement within second cavity 1234 in a configuration such that a second fluid, such as, for example, an orthopedic bone filler/cement, or other type of desirable medication/material is, for example, instilled into a fractured bone for treating vertebral and sacral fractures, as will be discussed.

Syringe 1214 has a tubular body 1238 that extends from a first end 1240 to a second end 1242. First end 1240 includes a flange 1244, which is releasably mounted with body 1202 via brackets 1246. Flange 1244 has tabs 1248 that can be rotated into and out of position with brackets 1246 for retaining and releasing syringe 1214 from body 1202. It is contemplated that syringe 1214 may also be releasably mounted with body 1202 by other structure such as a spring mechanism, insertion with body 1202, clips, threaded engagement, luer lock, etc. It is further contemplated that syringe 1214 may be permanently fixed within the body 1202 via adhesive, locking assembly, monolithically formed components, etc. It is envisioned that tubular body 1238 may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative cross section such as elliptical, polygonal, etc.

Second end 1242 has a nozzle 1250 configured to expel the bone filler/cement to the vertebral cavity. Nozzle 1250 is connected to an access tube or the like, discussed below, which is a conduit for the bone filler/cement to the vertebral cavity. It is contemplated that nozzle 1250 and its opening may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative opening sizes to regulate fluid flow.

An actuator 1252 is supported by a rearward portion 1254 of body 1202. Actuator 1252 includes a shaft 1256, which is operatively coupled to a gearing assembly 1258. Gearing assembly 1258 is supported by a forward portion 1260 of body 1202. Actuator 1252 is connected to first plunger 1218 and second plunger 1236 via gearing assembly 1258. It is contemplated that actuator 1252 may be directly connected to plungers 1218, 1236 using, for example, an axial force to move the plungers. It is further contemplated that a plurality of actuator may be employed to facilitate movement of the plungers, such as dedicated actuator for each plunger.

As shown in Figures 86 and 87, shaft 1256 extends to an end 1262, which has a bevel gear 1264 mounted thereto. Bevel gear 1264 is operatively coupled to a wheel gear 1266 having teeth disposed on an outer radial periphery thereof. The teeth of wheel gear 1266 mesh/engage with the teeth of bevel gear 1264. As actuator 1252 is manipulated for rotation in a particular direction, for example, clockwise or counterclockwise, shaft 1256 rotates bevel gear 1264 in a corresponding direction. In turn, bevel gear 1264 meshes with wheel gear 1266 to cause rotation thereof. Clockwise rotation of actuator 1252 causes clockwise rotation of wheel gear 1266. Counterclockwise rotation of actuator 1252 causes counterclockwise rotation of wheel gear 1266. Rotation of wheel gear 1266 causes corresponding and simultaneous rotation of a gear 1268, which is mounted with wheel gear 1266. Gear 1268 meshes/engages with a pinion gear 1270 and a pinion gear 1272, which rotate on respective shafts 1274, 1276 mounted with gearing assembly 1258.

Plunger 1218 includes a shaft 1278 having teeth 1280 axially disposed therealong. Teeth 1280 engage pinion gear 1270 to facilitate movement of first plunger 1218 relative to body 1220. For example, as actuator 1252 is manipulated for clockwise rotation, in the direction shown by arrow C, gear 1268 rotates in a clockwise direction. Gear 1268 causes pinion gear 1270 to rotate in a counterclockwise direction. Pinion gear 1270 meshes with teeth 1280 causing shaft 1278 to move first plunger 1218 within first cavity 1216 in a forward axial direction relative to body 1220, in the direction shown by arrow A. Such clockwise rotation of actuator 1252 causes plunger 1218 to expel a fluid, or prepare for drawing fluid, into first cavity 1216. Plunger 1218 includes a gasket 1282 that sealingly engages the inner wall of body 1220. This configuration establishes a vacuum pathway to create suction or expulsion pressure in the communication between first cavity 1216, the vertebral cavity and second cavity 1234, which includes intermediary access lines, tubing or devices.

Conversely, in an example such that actuator 1252 is manipulated for counterclockwise rotation, in the direction shown by arrow CC, gear 1268 rotates in a counterclockwise direction. Gear 1268 causes pinion gear 1270 to rotate in a clockwise direction. Pinion gear 1270 meshes with teeth 1280 causing shaft 1278 to move first plunger 1218 within first cavity 1216 in a rearward direction relative to body 1220, to draw fluid out of the vertebral cavity, facilitating the flow of filler/cement to the vertebral cavity from syringe 1214.

Plunger 1236 of syringe 1214 includes a shaft 1284 having teeth 1286 axially disposed therealong. Teeth 1286 engage pinion gear 1272 to facilitate movement of second plunger 1236 relative to body 1238. For example, as actuator 1252 is manipulated for clockwise rotation, in the direction shown by arrow C, gear 1268 rotates in a clockwise direction. Gear 1268 causes pinion gear 1272 to rotate in a counterclockwise direction. Pinion gear 1272 meshes with teeth 1286 causing shaft 1284 to move second plunger 1236 within second cavity 1234 in a rearward axial direction relative to body 1238, in the direction shown by arrow B. Such clockwise rotation of actuator 1252 causes plunger 1236 to draw a fluid into second cavity 1234. Plunger 1236 includes a gasket 1288 that sealingly engages the inner wall of body 1238. This configuration establishes a preferred vacuum pathway to create suction or expulsion pressure in the communication between first cavity 1216, the vertebral cavity and second cavity 1234, which includes intermediary access lines, tubing or devices.

Conversely, in an example such that actuator 1252 is manipulated for counterclockwise rotation, in the direction shown by arrow CC, gear 1268 rotates in a counterclockwise direction. Gear 1268 causes pinion gear 1272 to rotate in a clockwise direction. Pinion gear 1272 meshes with teeth 1285 causing shaft 1284 to move second plunger 1236 within second cavity 1234 in a forward direction relative to body 1238, in the direction shown by arrow A. Such counterclockwise rotation of actuator 1252 causes plunger 1236 to expel bone filler/cement out of second cavity 1234. Expulsion of the bone filler/cement is facilitated by the sealing engagement of gasket 1288 with the inner wall of body 1238, as discussed. This configuration facilitates a preferred pathway between second cavity 1234 and the vertebral cavity for the flow of filler/cement to the vertebral cavity from syringe 1214. This advantageously reduces the risk of filler/cement flowing out from the vertebral body. The preferred pathway discussed, prevents leakage of filler/cement and undesired filler/cement flow into adjacent structures such as intervertebral disc, spinal canal, neural foramina, and blood vessels.

Fluid transfer device 1200 includes syringes 1212, 1214 such that their respective plungers 1218, 1236 are linked. As plunger 1236 is driven forward, plunger 1218 is driven rearward, as discussed, to create a suction for drawing fluid out of the vertebral cavity of the vertebral body. This advantageous configuration of fluid transfer device 1200 and the methods described, creates a space in the vertebral cavity and a preferred pathway for instilling the bone filler/cement in the vertebral cavity. It is contemplated that alternative to a user manipulated actuator, plungers 1212, 1214 may be moveable via motors, which may include electronic circuitry and microprocessor control. Such control can be employed to monitor and regulate, via adjustment and calibration, the delivery of the bone filler/cement and pressure.

It is envisioned that fluid transfer device 1200 includes a pressure monitoring gauge (not shown), which is connected to the preferred pathway discussed. The pressure monitoring gauge is employed to monitor pressure in the preferred pathway and is connected to an automatic stop mechanism (not shown). The automatic stop mechanism can be activated to discontinue operation of fluid transfer device 1200 to advantageously prevent buildup of excessive pressure in the targeted bone to minimize the likelihood of filler/cement leak. It is further envisioned that such a pressure monitoring gauge may be connected at other locations of the preferred pathway such as with tubing or other devices employed. In one method of using fluid transfer device 1200, a bore may be created in bone of a vertebral or sacral body, to introduce and temporarily leave a tube, tubular sheath or the like. A tubular sheath may be used, which is configured to allow an instrument, component, tool or the like to pass therethrough and provide access to an area at or adjacent to the vertebral cavity of the vertebral body. Fluid transfer device 1200 may include radiolucent and radio opaque materials. Fluid transfer device 1200 may also include radio opaque markers for aligning components such as tubing, cannulas, needles, sheaths, etc., during a procedure for treating a vertebral body.

In another particular embodiment, in accordance with the principles of the present disclosure, a vertebral treatment system is provided. The vertebral treatment system includes components such as a bone drill, forceps, a cavity drill and a fluid transfer device for treating fractured bone of a vertebral body and/or a sacral body, similar to those described herein. It is envisioned that the vertebral treatment system may include one or all of the components discussed herein. It is further envisioned that the vertebral treatment system may include other components applicable to a vertebral treatment procedure and in accordance with the present disclosure.

The vertebral treatment system employs, for example, a bone drill 410, as shown in Figure 88 and described above with regard to Figures 20-45, and a cavity drill 610, as shown in Figure 90 and described above with regard to Figures 46-74. The vertebral treatment system also employs a fluid transfer device, similar to that described above with regard to Figures 82-87, and a forceps 1300, as shown in Figure 90 and described above with regard to Figures 75-81. It is envisioned that the vertebral treatment system may employ alternative components. Other uses of the described components of the vertebral treatment system are also contemplated.

In operation of the vertebral treatment system, bone drill 410 is employed with a method for treating fractured bone of a vertebral body or a sacral body. The components of bone drill 410 are fabricated, properly sterilized and otherwise prepared for use. Bone drill 410 is provided with handle portion 414, drive portion 416 and head portion 418 in a configuration that provides a safe distance between a physician and radiation emitted during the procedure.

Head portion 418 includes radioopaque markers 464 disposed in a configuration to facilitate alignment of sheath 457 with bone of the vertebral body (Figure 90). During fluoroscopy, an area is exposed to radiation, which includes bone drill 410 and the bone of the vertebral body. The exposure of radiation to bone drill 410 and radioopaque markers 464 allows the user to identify the location of sheath 457 and drill bit 458 relative to the targeted bone. This configuration facilitates alignment, via radioopaque markers 464, for cutting the bone while protecting the user by maintaining the offset angular orientation of bone drill 410, discussed above. A guard 710, discussed herein, may also be used during the procedure.

Forceps 1300 is provided to stabilize and guide bone drill 410 during drilling of bone of the vertebral body. Forceps 1300 includes radioopaque arms 1324, 1326 having jaws 1328, 1329. The exposure of radiation to forceps 1300 and radioopaque arms 1324, 1326 allows the user to identify the location of jaws 1328, 1329 relative to sheath 457 and drill bit 458 of bone drill 410. This configuration facilitates guidance for drilling and protects the user from radiation by maintaining the hands of the user a safe distance therefrom.

Drill bit 458 engages the bone and rotates via motor 498 to bore a cavity in the bone Sheath 457. is driven into engagement with the bone to further define the cavity in the bone After drill bit 458 has reached a desired depth within the targeted bone, according to the requirements of a particular procedure, actuator 1304 of forceps 1300 can release jaws 1328 1329 from sheath 457. Sheath 457 is free to rotate. If desired, forceps 1300 may be removec from sheath 457.

Cavity drill 610, which is an alternate embodiment of bone drill 410, is provided foi enlarging and/or further defining the cavity bored in the bone by bone drill 410. Cavity drill 61( includes a knob 620, which is manipulated for rotation to drive a bone curette 622, which ream: the targeted bone and cavity. Cavity drill 610 also includes a knob 632, which is manipulated fo rotation to cause relative axial translation of bone curette 622. Knobs 620, 632 are rotated, in cooperation to ream the targeted bone area and further define the targeted bone cavity. It is contemplated that cavity drill 610 may include radioopaque markers to facilitate alignment thereof with the targeted bone.

After the cavity is created in the targeted vertebral bone, according to the requirements for the particular fracture and treatment procedure, the targeted vertebral body or sacral body is treated. See, for example, the description of methods of use described herein. It is contemplated that one or a plurality of cavities may be created to allow for access tubing, cannulas, etc. in the targeted area. It is further contemplated that balloon catheters, etc., may be inserted through the access tubing, cannulas, etc. into the targeted fractured vertebral body. Bone fillers/cement may then be instilled into the bone. It is envisioned that the access tubing, cannulas, etc. may be fabricated from radiolucent material and/or radioopaque material.

A fluid transfer device 1200 is provided for treating a fracture of a vertebral body 1400 having a vertebral cavity 1402, as shown in Figure 10. Bone drill 410, forceps 1300 and cavity drill 610, as discussed, create drilled access cavities 1404, 1406. Access cannulas 1408, 1410 are inserted for positioning with access cavities 1404, 1406.

Tubing 1412, 1414 are connected with access cannulas 1408, 1410. Tubing 1412 is connected to nozzle 1232 and tubing 1414 is connected to nozzle 1250. Syringes 1212, 1214, tubing 1412, 1414, cannulas 1404, 1406 and vertebral cavity 1402 are in fluid communication to establish a preferred vacuum pathway to create suction and expulsion pressure between syringes 1212, 1214 and vertebral cavity 1402 for treating a fracture of vertebral body 1400.

To instill an orthopedic bone filler/cement such as PMMA (Polymethyl methacrylate) into vertebral cavity 1402, fluid transfer device 1200 draws body fluid out of vertebral cavity 1402 and instills PMMA therein. Actuator 1252 is manipulated for counterclockwise rotation, in the direction shown by arrow G. First plunger 1218 is caused to move within first cavity 1216 in a rearward direction, in the direction shown by arrow H, discussed above. Accordingly, body fluid is drawn out of vertebral cavity 1402, in the direction shown by arrows I. As actuator 1252 is rotated counterclockwise, second plunger 1236 is caused to move within second cavity 1234 in a forward direction, in the direction shown by arrow J. Accordingly, plunger 1236 expels PMMA out of second cavity 1234, in the direction shown by arrows K, and into vertebral cavity 1402. This advantageous configuration removes body fluid and instills bone filler/cement simultaneously, as facilitated by the preferred communication pathway between syringe 1212 and syringe 1214. This design of the vertebral treatment system and fluid transfer device 1200 has several benefits including increased patient safety by reducing the risk of leakage of bone filler/cement and undesired flow of filler/cement into adjacent structures such as the intervertebral disc, spinal canal, neural foramina, and blood vessels.

The PMMA instilled in vertebral cavity 1402 hardens to provide strength and stability to the vertebra. It is envisioned that the vertebral treatment system employing fluid transfer device 1200 may be continuously monitored using fluoroscopy guidance. It is further envisioned that the vertebral treatment system may be employed with various treatment procedures such as vertebral augmentation, vertebroplasty, sacroplasty, osteoplasty, etc.

While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that embodiments have been shown and described and that all changes and modifications that come within the spirit of this invention are desired to be protected.

Claims

WHAT IS CLAIMED IS:

1. A bone drill comprising:

a first portion connected to a second portion, the first portion defining a first axis and the second portion defining a second axis, the second axis being disposed at an angle relative to the first axis; and

a third portion being connected to the second portion, the third portion having a shaft extending therefrom, the shaft including a distal end configured to engage bone.

2. A bone drill as recited in claim 1, further comprising radio opaque markers configured for alignment of the bone drill during a fluoroscopy procedure.

3. A bone drill as recited in claim 1, wherein the third portion is formed of the radiolucent material and the shaft is formed of radiolucent and radio opaque materials.

4. A bone drill as recited in claim 1, wherein the third portion includes a drilling assembly having a drill bit and a sheath of the shaft extending about the drill bit.

5. A bone drill as recited in claim 4, wherein the sheath is configured to rotate independent of the drill bit and subsequent to drilling of a hole to a partial depth by the drill bit.

6. A bone drill as recited in claim 1, wherein the shaft is configured to rotate relative to the third portion.

7. A bone drill as recited in claim 4, wherein the sheath is configured to rotate in an oscillating configuration such that the distal end rotates in a clockwise direction and a counterclockwise direction.

8. A bone drill as recited in claim 1, wherein the shaft is configured for axial movement relative to the third portion.

9. A bone drill as recited in claim 8, wherein the axial movement is spring driven to facilitate an impact engagement of the distal end and the bone.

10. A bone drill as recited in claim 1, wherein the third portion defines a third axis, the third axis being disposed at an angular orientation relative to the second axis.

11. A method for treating a vertebral body, the method comprising the steps of:

providing a bone drill, the bone drill comprising:

a first portion connected to a second portion, the first portion defining a first axis and the second portion defining a second axis, the second axis being disposed at an angle relative to the first axis, and

a third portion being connected to the second portion, the third portion having a shaft extending therefrom, the shaft including a distal end configured to engage bone, wherein the third portion includes a drilling assembly having a drill bit and a sheath of the shaft extending about the drill bit, the third portion further including radio-opaque markers disposed in a configuration to facilitate alignment of the sheath with bone of the vertebral body;

exposing an area including the bone drill and the bone to radiation to facilitate alignment, via the radio-opaque markers, of the sheath with the bone while providing radiation protection for a user by maintaining the second axis at the angular orientation relative to the first axis, thus increasing the distance of the user from the primary radiation source and scatter radiation from the patient;

engaging the distal end of the shaft with the bone;

rotating the drill bit and engaging the drill bit with the bone to create a cavity in the bone;

driving the sheath into engagement with the bone to further define the cavity in the bone; and

treating the bone.

12. A method for treating a vertebral body as recited in claim 11, wherein the step of treating includes treating vertebral compression fractures.

13. A method for treating a vertebral body as recited in claim 11, wherein the step of treating includes treating sacral fractures.

14. A method for treating a vertebral body as recited in claim 11, wherein the step of treating includes treating lytic tumor deposits in the bone.

15. A method for treating a vertebral body as recited in claim 11, further comprising the step of providing access for bone biopsies and bone infusions using imaging guidance.

16. A method for treating a vertebral body as recited in claim 11, further comprising the step of providing a drill driven screwdriver for use with imaging guidance.

17. A bone drill as recited in claim 1, further comprising a radiation protection guard mounted to the first portion.

18. A bone drill configured for treating bone of a vertebral body, the drill comprising:

a handle connected to a drive housing, the drive housing being connected to a head portion, the head portion including a shaft extending therefrom,

the shaft including a drill bit and a sheath disposed about the drill bit,

the shaft being coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath.

19. A bone drill configured for treating bone of a vertebral body as recited in claim 18, wherein the handle defines a first axis and the drive housing defines a second axis, the second axis being disposed at an angular orientation relative to the first axis.

20. A bone drill configured for treating bone of a vertebral body as recited in claim 18, wherein the head portion defines a third axis, the third axis being disposed at an angular orientation relative to the second axis.

21. A bone drill configured for treating bone of a vertebral body as recited in claim 18, wherein the head portion includes radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

22. A bone drill as recited in claim 1, wherein the angular orientation is in a range of 0 to 45 degrees.

23. A bone drill as recited in claim 10, wherein the third axis is disposed at an angular orientation relative to the second axis in a range of 0 to 45 degrees.

24. A bone drill as recited in claim 4, wherein the sheath rotates at a first speed and the drill bit rotates at a second speed.

25. A bone drill as recited in claim 4, further comprising a brake configured to control rotation of the sheath.

26. A bone drill as recited in claim 4, wherein the sheath includes external threads that are. configured to control feed rate of the drill bit.

27. A bone drill as recited in claim 26, wherein the sheath includes a radially extending stop.

28. A bone drill as recited in claim 4, wherein the drill bit has an outer drill bit and an inner drill bit.

29. A bone drill as recited in claim 4, wherein the outer drill bit is removable from the sheath for implanting with bone.

30. A bone drill as recited in claim 1, wherein the distal end of the shaft includes a plurality of cutting tines.

31. A bone drill as recited in claim 1, wherein the distal end of the shaft includes a plurality of cutting tines, which are movable relative to the distal end of the shaft.

32. A method for treating a vertebral body as recited in claim 11, wherein the steps oi engaging, rotating and driving are performed simultaneously.

33. A bone drill as recited in claim 4, wherein the components of the drilling assembly independently rotate at variable speeds.

34. A bone drill as recited in claim 4, wherein the components of the drilling assembly independently axially movable.

35. A cavity drill configured for use with a bone drill comprising:

a body;

the bone drill having a first portion being movably connected to a second portion, and a third portion being movably connected to the second portion, the body being mounted with the third portion of the bone drill; and

a sheath extending from the third portion to a distal end, a continuously rotatable curette being connected with the distal end and configured for engaging bone.

36. A cavity drill as recited in claim 35, wherein at least a portion of the cavity drill is radiolucent.

37. A cavity drill as recited in claim 35, further comprising radio opaque markers configured for determination of size and length of a cavity being created during a fluoroscopy procedure.

38. A cavity drill as recited in claim 35, wherein the body is formed of the radiolucent material and the sheath and the curette are formed of a radio opaque material.

39. A cavity drill as recited in claim 35, further comprising a handle extending from the body, the handle being connected with the curette wherein the handle is manipulable in a configuration that causes movement deployment and retraction of the curette blades.

40. A cavity drill as recited in claim 39, wherein the handle is connected to the curette in a gearing disposed with the body.

41. A cavity drill as recited in claim 35, wherein the sheath is configured to rotate in an oscillating configuration such that the distal end rotates in a clockwise direction and a counterclockwise direction.

42. A cavity drill as recited in claim 35, wherein the sheath is configured for axial movement relative to the body such that cutting blades of the curette move continuously in one direction or the other

43. A cavity drill as recited in claim 35, wherein the third portion is disposed at an angular orientation relative to the first portion of the bone drill.

44. A cavity drill as recited in claim 35, further comprising a radiation protection guard mounted to the bone drill.

45. A bone drill configured for treating bone of a vertebral body, the drill comprising:

the shaft including a drill bit and a sheath disposed about the drill bit,

the shaft being coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath; and

a cavity drill mountable with the head portion and including the sheath, the sheath having a curette disposed at a distal end thereof.

46. A bone drill configured for treating bone of a vertebral body as recited in claim 45, wherein the head portion includes radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

47. A cavity drill configured for use with a bone drill, the cavity drill comprising;

a body having a sheath with cutting blades extending therefrom and being mounted with the bone drill, the body supporting gearing that operatively couples the sheath to a motor of the bone drill for rotation of the sheath and the cutting blades.

48. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the cutting blades extend from the sheath and is configured to rotate in an oscillating configuration such that the cutting blade rotates in a clockwise direction and a counterclockwise direction.

49. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the sheath is configured for axial movement relative to the body such that the cutting blades move continuously in one direction or the other.

50. A cavity drill configured for use with a bone drill as recited in claim 49, wherein the axial movement is spring driven to facilitate impact engagement of the sheath with bone of vertebral body.

51. A cavity drill configured for use with a bone drill as recited in claim 47, further comprising a handle extending from the body, the handle being connected with the curette wherein the handle is manipulable in a configuration that causes movement of a curette being disposed with a distal end of the sheath.

52. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the gearing is configured to convert a rotation of the motor to oscillation of the cutting blade.

53. A cavity drill configured for use with a bone drill as recited in claim 52, wherein the cutting blade excises a defined arc in bone.

54. A cavity drill configured for use with a bone drill as recited in claim 53, wherein the defined arc is approximately 60 degrees.

55. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the body has a handle with snapping features to lock and release from the bone drill.

56. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the cutting blades extend continuously from minimal to full extension in a radial configuration.

57. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the cutting blades are pushed out from an outer tube by a pusher, the cutting blades being forced to slide through the outer tube in a predetermined configuration.

58. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the cutting blades have radio opaque markers to increase conspicuity.

59. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the cutting blades are configured to resist deflection during cutting.

60. A cavity drill configured for use with a bone drill as recited in claim 47, wherein the cutting blades are driven at variable speeds.

61. A radiolucent forceps adapted for treating bone, the forceps comprising:

a handle including an actuator pivotably connected therewith;

a shaft extending from the handle, a proximal end of the shaft being operatively engageable with the actuator; and

an elongated member extending through the shaft and having a proximal end and a distal end, the proximal end being affixed to the handle and the distal end including opposing arms configured to grasp.

62. A forceps as recited in claim 61, wherein the actuator operatively engages the shaft to cause axial movement thereof relative to the elongated member.

63. A forceps as recited in claim 62, wherein the shaft is axially moveable between ε retracted position, whereby the arms are in a substantially open position, and an extendec position, whereby the arms are in a substantially closed position.

64. A forceps as recited in claim 63, wherein the arms define a cylindrical cavity ir the closed position.

65. A forceps as recited in claim 61, wherein the arms are outwardly biased.

66. A forceps as recited in claim 61, wherein the arms are outwardly biased via i spring.

67. A forceps as recited in claim 61, wherein the elongated member and the shaft ar< fabricated from a radiolucent material.

68. A forceps as recited in claim 61, wherein the arms are fabricated from a radiolucent material.

69. A forceps as recited in claim 61, wherein the arms are configured to support a bone drill shaft.

70. A vertebral treatment system comprising:

a bone drill configured for treating bone of a vertebral body, the bone drill including a handle moveably connected to a drive housing, the drive housing being moveably connected to a head portion, the head portion including a shaft extending therefrom, the shaft including a drill bit and a sheath disposed about the drill bit, the shaft being coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath, wherein the head portion is disposed at an angular orientation relative to the handle.

71. A vertebral treatment system as recited in claim 70, further comprising a cavity drill including a body having a sheath extending therefrom and being mounted with the bone drill, the body supporting gearing that operatively couples the sheath to a motor of the bone drill for rotation of the sheath.

72. A vertebral treatment system as recited in claim 70, further comprising a forceps including a handle including an actuator pivotably connected therewith, a shaft extending from the handle with its proximal end being operatively engageable with the actuator, and an elongated member extending through the shaft and having a proximal end and a distal end, the proximal end being affixed to the handle and the distal end including opposing arms configured to grasp.

73. A vertebral treatment system as recited in claim 70, wherein the head portion includes radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

74. A vertebral treatment system as recited in claim 70, wherein at least a portion of the bone drill is radiolucent.

75. A vertebral treatment system as recited in claim 71, wherein the cavity drill includes radio opaque markers disposed in a configuration to facilitate alignment during a fluoroscopy procedure.

76. A vertebral treatment system as recited in claim 71, wherein at least a portion ol the cavity drill is radiolucent.

77. A vertebral treatment system as recited in claim 72, wherein at least a portion oJ the elongated member of the forceps is radiolucent.

78. A vertebral treatment system as recited in claim 72, wherein the jaws are configured to grasp the shaft of the bone drill.

79. A largely radiolucent forceps device designed to provide radiation protection foi the operator's hand by increasing the distance between the patient/X-ray beam and the operator's hand.

80. The forceps as recited in claim 79, wherein the forceps may have a radiatior protection guard on its handle; the guard may be rotatable and/or removable.

81. A vertebral treatment system adapted for treating bone lesions including vertebra: and sacral fractures, bone tumors, for performing bone biopsies/infusions, and for facilitating other medical procedures requiring fluoroscopic guidance comprising:

a bone drill configured for treating bone of a vertebral body, the bone drill including ε handle moveably connected to a drive housing, the drive housing being moveably connected to ∑ head portion, the head portion including a shaft extending therefrom, the shaft including a dril bit and a sheath disposed about the drill bit, the shaft being coupled to a motor disposed with tht drive housing via gearing such that the motor rotates the drill bit and the sheath, wherein th« head portion is disposed at an angular orientation relative to the handle;

a cavity drill including a body having a sheath extending therefrom and being mountec with the bone drill, the body supporting gearing that operatively couples the sheath to a motor o: the bone drill for rotation of the sheath; and a forceps including a handle including an actuator pivotably connected therewith, a shaft extending from the handle with its proximal end being operatively engageable with the actuator, and an elongated member extending through the shaft and having a proximal end and a distal end, the proximal end being affixed to the handle and the distal end including opposing arms configured to grasp.

82. A forceps as recited in claim 61 , wherein the forceps is configured for use with X- ray (fluoroscopic) guidance.

83. A fluid transfer device adapted to treat a vertebral body, the fluid transfer device comprising:

a first cavity having a first plunger disposed therewith, the first plunger being configured to draw a first fluid into the first cavity;

a second cavity having a second plunger disposed therewith, the second plunger being configured to expel a second fluid from the second cavity; and

an actuator being connected to the first plunger and the second plunger.

84. A fluid transfer device as recited in claim 83, further comprising a body having a first cylinder, the first cylinder defining the first cavity and supporting the first plunger.

85. A fluid transfer device as recited in claim 84, wherein the body has a second cylinder, which defines the second cavity and supports the second plunger.

86. A fluid transfer device as recited in claim 83, wherein the first cavity and the second cavity communicate with a vertebral cavity of the vertebral body.

87. A fluid transfer device as recited in claim 83, wherein the actuator is operatively coupled to the first plunger and the second plunger via a gearing assembly.

88. A fluid transfer device as recited in claim 87, wherein the first plunger includes a shaft having teeth axially disposed therealong, the teeth engaging the gearing assembly to facilitate movement of the first plunger.

89. A fluid transfer device as recited in claim 88, wherein the second plunger includes a shaft having teeth axially disposed therealong, the teeth of the second plunger engaging the gearing assembly to facilitate movement of the second plunger.

90. A fluid transfer device as recited in claim 89, wherein the actuator is rotatable such that the gearing assembly engages the shafts of the plungers to facilitate movement thereof.

91. A fluid transfer device adapted to treat a vertebral body having a vertebral cavity, the fluid transfer device comprising:

a body supporting a first cylinder and a second cylinder, the first cylinder defining a first cavity and supporting a first plunger disposed for axial movement within the first cavity such that a first fluid is drawn into the first cavity, the first cavity having a shaft including a plurality of axially disposed teeth,

the second cylinder defining a second cavity and supporting a second plunger disposed for axial movement within the second cavity such that a second fluid is expelled from the second cavity, the second plunger having a shaft including a plurality of axially disposed teeth; and

an actuator being supported by the body and operatively coupled to a gearing assembly supported by the body, the gearing assembly being operatively coupled to the teeth of the firsi plunger and the second plunger,

wherein the actuator causes movement of the first plunger and the second plunger via the gearing assembly, and the first and second cavities being in communication with the vertebra cavity.

92. A fluid transfer device as recited in claim 91, wherein the body includes a handle.

93. A fluid transfer device as recited in claim 91, wherein the actuator is rotatable.

94. A fluid transfer device as recited in claim 91, wherein the gearing assembly includes a first pinion gear that engages the teeth of the first plunger and a second pinion gea that engages the teeth of the second plunger, the pinion gears engaging a gear that is operativeh connected to the actuator.

95. A fluid transfer device as recited in claim 91, wherein the second plunger is configured to instill a bone filler into targeted bone.

96. A method for treating a vertebral body having a vertebral cavity, the method comprising the steps of:

providing a fluid transfer device; and

simultaneously withdrawing a first fluid from the vertebral cavity and instilling cement into the vertebral cavity in a configuration to create a preferred pathway from the fluid transfer device to the vertebral cavity allowing uniform distribution of the cement throughout targeted bone.

97. A vertebral treatment system comprising:

an off-angle, radiolucent bone drill configured for treating bone of a vertebral body, the bone drill including a handle connected to a drive housing, the drive housing being connected tc a head portion, the head portion including a shaft extending therefrom, the shaft including a drill bit and a sheath disposed about the drill bit, the shaft being coupled to a motor disposed with the drive housing via gearing such that the motor rotates the drill bit and the sheath; and

a fluid transfer device including a first cavity having a first plunger disposed therewith the first plunger being configured to draw a first fluid into the first cavity, a second cavity having a second plunger disposed therewith, the second plunger being configured to expel a second fluic from the second cavity, and an actuator being connected to the first plunger and the seconc plunger.

98. A vertebral treatment system as recited in claim 97, further comprising a cavirj drill including a body having a sheath extending therefrom and being mounted with the bon< drill, the body supporting gearing that operatively couples the sheath to a motor of the bone dril for rotation of the sheath and cutting blades having radio opaque markers.

99. A vertebral treatment system as recited in claim 97, further comprising i radiolucent forceps including a handle including an actuator pivotably connected therewith, i shaft extending from the handle, and an elongated member extending through the shaft and having a proximal end and a distal end, the proximal end being operatively engageable with the actuator and the distal end including opposing arms configured to grasp.

100. A vertebral treatment system as recited in claim 97, wherein the head portion includes radio opaque markers disposed in a configuration to facilitate alignment of the shaft during a fluoroscopy procedure.

101. A fluid transfer device as recited in claim 83, wherein the second plunger is configured to instill a bone filler into targeted bone.

102. A fluid transfer device as recited in claim 83, wherein the second plunger is configured to instill medication into targeted bone.

103. A fluid transfer device as recited in claim 91, wherein the second plunger is configured to instill medication into targeted bone.

104. A fluid transfer device as recited in claim 83, wherein the first cavity and the second cavity are connected to a vertebral cavity of the vertebral body via a preferred pathway, the fluid transfer device further comprising a pressure monitoring device connected to the preferred pathway.

105. A fluid transfer device as recited in claim 104, wherein the pressure monitoring gauge is connected to a stop mechanism configured for activation to discontinue operation of the fluid transfer device.

106. A fluid transfer device as recited in claim 91, wherein the first cavity and the second cavity are connected to the vertebral cavity via a preferred pathway, the fluid transfer device further comprising a pressure monitoring device connected to the preferred pathway.

107. A fluid transfer device as recited in claim 106, wherein the pressure monitoring gauge is connected to a stop mechanism configured for activation to discontinue operation of the fluid transfer device.