WO2007121059A2

WO2007121059A2 - Volumetric measurement and visual feedback of tissues

Info

Publication number: WO2007121059A2
Application number: PCT/US2007/065346
Authority: WO
Inventors: Jeffrey H. Nycz; Carlos E. Gil; William T. Donofrio; Jettendra Bharadwaj
Original assignee: Warsaw Orthopedic, Inc.
Priority date: 2006-04-11
Filing date: 2007-03-28
Publication date: 2007-10-25
Also published as: US7918796B2; US8137277B2; US20070238998A1; WO2007121059B1; US20110160587A1; WO2007121059A3

Abstract

Apparatus and methods for assessing tissue characteristics such as the dimensions and volume of an osteolytic lesion are disclosed. The apparatus may utilize ultrasound to provide visual and volumetric feedback related to a lesion or other tissue. Further the apparatus may be utilized to determine whether the lesion has been completely removed and filled with the appropriate amount of graft material.

Description

LlIMETRIC MEASUREMENT AND VISUAL FEEDBACK OF TISSUES

5 TECHNICAL FI ELD

The present disclosure is directed to improved instrumentation and methods for assessing characteristics of a tissue. More particularly, in one aspect the present disclosure is directed toward instruments and methods for assessing characteristics of a lesion.

IO BAC KGROUND

The present disclosure relates to the assessment of various characteristics of tissues, including the size and dimensions of osteolytic lesions. Joint prostheses often include an articulating surface composed of a material designed to minimize the friction between components of the joint prostheses For example, in a hip prosthesis the femoral

15 component h comprised of a head (or ball) and a stem attached to the femur The acetabular component is comprised of a cup (or socket) attached to the acetabulum and most often includes a polyethylene articulating surface. The ball-in-socket motion between the femoral head and the acetabular cup simulates the natural motion of the hip joint and the polyethylene surface helps to minimize friction during articulation of the ball

20 and socket However, this articulation has been shown to release submicron particle wear debris, often polyethylene wear debris The release of this debris into the body has been shown to lead to the development of osteolytic lesions.

Current techniques for treating lytic and cancerous lesions include deforiding the lesion and filling the remaining defect with graft materials Currently surgeons lack a

25 convenient and accurate way to confirm the exact location of the lesion, whether the lesion has been completely removed, and whether the remaining void has been property filled with graft material. Further, advanced treatment options use osteoinductive and osteoinductive materials to heal the lesion. These materials require an accurate assessment of the volume and shape of the lesion to ensure that the appropriate amount of

30 biological agent is introduced into the lesion to promote rapid bone growth and healing.

Therefore, there remains a need for improved instruments and methods of evaluating characteristics of tissue and, in particular, bone lesions. SUMMARY

In one embodiment, a system for determining a characteristic of a lesion of a bone is provided. The system includes a hand-held ultrasound device for defecting indicators of a lesion, a processor for determining a characteristic of the lesion based on the detected 5 indicators, and a display for displaying a representation of the characteristic In one aspect, a coupling attachment is provided to enable effective conductive coupling between the ultrasound device and the bone

In another embodiment, a method of treating a lesion of a bone is provided The method includes providing an ultrasound device, a processor, and a display. The method So includes sensing the signals of the ultrasound device reflected from the bone and lesion, determining a lesion model based on the sensed signals, and displaying at least one characteristic of the lesion model.

Further aspects, forms, embodiments, objects, features, benefits, and advantages of the present invention shall become apparent from the detailed drawings and descriptions i 5 provided herein

BRIEF DESCRIPTION OF THE DRAWINGS

Fig Hs a front \iew of one embodiment of a system for determining a characteristic of a lesion of a bone in use with an artificial acetabular cup.

20 Fig 2 is an enlarged front view of a portion of Fig 1

Fig. 3 is an enlarged side view of a portion of Fig. 1

DESCRIPTION

For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and 25 specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended Any alterations and further modifications in the described devices, instruments, methods, and any further application of the principles of the disclosure as described herein are contemplated as would normally occur to one skilled in the art to which the disclosure relates. 3

Referring now to Figs I -3, there is shown a system 100 for assessing the volume and dimensions of an osteolytic lesion Fig 1 shows the system 100 being utilized to assess an osteolytic lesion 12 of a patient's acetabulum 10 where the patient has an artificial hip prosthesis The hip prosthesis includes an artificial acetabular cup 20. The 5 system 100 includes a hand-held ultrasonic device ! 10, a processor 140, and a display 150

Although shown separately, the processor may be incorporated into the hand-held device 1 10, the display 150, or be a stand alone unit. For example, in one embodiment the display and the processor are parts of a desk top computer or similar device Further, in some embodiments, the display 150 is incorporated into the hand-held device 1 10. Thus,

K) in at least one embodiment the system 100 consists of a hand-held device that incorporates both the processor 140 and the display 150 Examples of similar systems are disclosed in U.S. Patent Applications tiled February 17, 2006 as Serial No. \ 1 ''356,643 entitled "Surgical Instrument to Assess Tissue Characteristics,^" and Serial No. 1 1/336,687 entitled "^"Sensor and Method for Spinal Monitoring,^*' that are herein incorporated by reference in ϊ5 their entirety.

The hand-held device 1 10 has a body 112, a proximal end 1 14, a distal end 1 16 and a cable 1 15 connecting the device to the processor 140 In Fig 1 , the body 1 12 is shown as being substantially cylindrical and elongated. This is merely for illustrative purposes. The body 112 may take any shape, including non-cylindrical and non-elongated

20 designs, capable of holding the electrical and mechanical components of the hand-held device 100 The body 1 12 includes a gripping surface 1 18 for grasping by the user or engagement with another instrument. The gripping surface 1 18 may include protrusions, recesses, or other features to facilitate engagement with another instrument. In one embodiment the gripping surface 1 18 is disposed closer to the proximal end 1 14 than to

25 the distal end 1 10 A transmitter 120 is disposed adjacent the distal end 1 K>,

In some embodiments the transmitter 120 is an ultrasound device, In that regard, the transmitter 120 is adapted to ρro\ ide informati on or data to the processor 140 through cable 1 15 that may be processed to create 3 dimensional ("3-D") models and volumetric data related to osteolytic lesion 10 using ultrasound. In some embodiments the transmitter 30 120 is adapted to produce ultrasound waves that \\t\\ pass through a portion of an artificial implant, such as the acetabular cup 20. In one embodiment, the transmitter 120 consists of an acoustic transducer that is adapted for emitting acoustic signals and detecting the 4 ieflected acoustic signals The acoustic transducer may function as a pulse-echo transducer having a single element for emitting and receh ing acoustic signals The tiammitter 120 includes an energy souice foi pϊodυcing oi emitting the acoustic oi ultrasound signal and a sensor for detecting the echo or reflected signal In one 5 embodiment, the functions of the energy source and the sensor aie performed by a single component switched between a transmit mode and a listen mode In another embodiment, the transmitter 120 includes two components The first component is configured for emitting signals and a second component is configured to receh e or detect the returned signals id It is to be understood that ultrasound i s a form of transmitted energy In alteroati v e embodiments other forms of energ\ and different frequencies are used, such as other types of acoustics, lasers, visible Sight, radio frequency, microχsa\es, etc , provided the> can be transmitted into the lesion and/or tissue For instance, the signals disclosed in the present embodiment are in the frequency range of ultrasonic signals In some high resolution ϊ5 <Λ stems of the present disclosure, the frequency can range from 20 KH/ up to and exceeding 3(KJ MHz I- or example, these frequencies may be used in acoustic microscopic instrument applications In one aspect of the present disclosure, the frequency iange is between 1 \lf ϊ/ to 15 MHz Still further, the energy source ina\ be any source capable of transmitting energy into the affected region to obtain characteristics of the tissue For

20 example, in some embodiments the energy source utilizes RF energy in the range from

400 KHz up to IO GHz Still further, in some embodiments the energ> source utilizes a light source generating non-coherent light, coherent (laser) light, or a combination of the two

The strength and frequency of the signal can be varied depending on the type of 25 tissue being e\aluated Further, the strength and frequency of the signal ma> be varied to enhance the accuracy of evaluation of a lesion boundary For instance, in one aspect the system 100 evaluates the lesion void with multiple energy beams with different frequencies and then integrates or combines the sensed signal information utilizing the processor to best approximate the size and location of the void Further, in another aspect "iθ the energ\ beam or signal is shaped for optimum performance and in some embodiments are focused beams, such as beams with a substantially cylindrical or conical shape As shown in Figs 2 and 3, the osteo!>tic lesion 12 may have an irregular boundary 14 5 between the good bone and the lesion In still another aspect, the signal is adapted to precisely detect the contours of the boundary 14. This is accomplished by such means as using a phased array of transducers, utilizing fiducial markers in combination with the signals, or any other suitable means in an additional embodiment, one or more 5 secondary or ancillary acoustic energy sources separate from the transmitter 120 are applied to the body near the honey area of interest The energy transmitted by these secondary sources passes through or reflects from the bone and lesion and is sensed by the transmitter 120. This additional information is included in the data used to create a 3-D model representative of at least a portion of a lesion. id To increase the efficiency and accuracy of the transmitter 120, and in particular the transmission of signals into the tissue, the distal end 1 !(> of the hand-held device 1 10 is shaped to substantially match the contours of a surface of the tissue or a corresponding implant such that the hand-held device and the tissue or implant are in conductive contact. That is, the hand-held device and implant are in sufficient conductive contact, not f 5 necessarily direct contact, to facilitate transmission of energy signals into the osteolytic lesion and surrounding tissue In one embodiment, the exterior of the distal end 1 iό of the hand-held device 1 10 is adapted to selectively engage a coupling attachment 122 formed of an ultrasonic conductive materia! that is shaped to mate with the acetabular cup 20, as shown in Fig. 1. The coupling attachment 122 has an internal cavity adapted to receive at

20 least a portion of distal end 1 16 This internal cavity may have a fixed geometry or may include a malleable material such as an elastomeric material such that the internal cavity can conform to different sizes and shapes of distal ends 1 IO on the hand-held device as may occur from different manufacturers. Further., in another aspect the system 100 includes a plurality of coupling attachments 122 having different shapes and sizes

25 corresponding to different types and sizes of acetabular cups to effectively transmit acoustic energy through the coupler while generating few, if any, unwanted artifacts The appropriate shape and size of coupling attachment 122 is chosen based on the patient and/or the size of the artificial implant. In a further aspect, a series of coupling attachments 122 are shaped to precisely mate with a specific type model of acetabular cup

>o from a specific manufacturer. A series of coupling attachments 122 is provided to matchup with more than one model of acetabular cup, including those made by different manufacturers. Further, although the illustrated implant appears to have a substantially 6

uniform curvature, it ia contemplated thai in alternative embodiments the coupling attachment will have an asymmetrical form to match a similar asymmetrical form on the implant. hi some embodiments the coupling attachment 122 is at least partially malleable to 5 facilitate more intimate coupling with the implant or tissue of the patient by conforming to the surface The malleable material may be a moldable putty type material, an elastomeric material such as PORON® foam or silicon, a gel or other suitable materials. Thus, the coupling attachment 122 need not always be specifically designed to match a particular implant Rather, in these embodiments the coupling attachment 122 has at least an io external surface that is malleable to mate with numerous implants of different shapes and sizes In a further embodiment, a coupling fluid (not shown) is provided between the coupling attachment 122 and the artificial implant. In this form, the coupling attachment 122 is in enhanced conductive communication with the implant via a coupling fluid. The coupling fluid may be used to increase the efficiency of the transmission of energy signals, ϊ5 including ultrasound, from the instrument through the implant and info the bone Also, in some embodiments the distal end 1 16 itself of the hand-held device 1 10 is shaped to match, the corresponding surface without the need for a coupling attachment.

The coupling attachment 122 is adapted for placement at the distal end 1 16 such that when the system 100 is in use the hand-held unit 100 can emit a signal or other type of

20 energy wave into the tissue being monitored and receive an echo or return signal. To this end, in one embodiment, the coupling attachment 122 includes a conductive surface. Conductive surface in this context does not require, but may include electrical conductivity Conductive surface in this context is intended to mean a surface configured to facilitate the emitting and receh ing of the ultrasound or other energy signals. Thus, the

25 surface may serve as a transducer to emit the signals or receive the signals, or the surface may simply be transrøissi\ e allowing the signals to pass through. In some embodiments, the acetabular cup 20 or other artificial implant is utilized as the conductive surface to facilitate transmission of the signals into the tissue. In this way, the acetabular cup 20 is a part of the system 100 in some embodiments That is, in some embodiments the hand-held

30 device 1 10 is coupled to the acetabular cup 20 via coupling attachment 122 such that the acetabular cup is utilized to transmit and receive the signals Other types of implants 7 besides acetabular cups may be used to transmit and receive the signals, In some embodiments, the signals merely pass through the acetabular cup 20.

Consider the case of an osteolytic lesion 12 of the acetabulum 10, as shown in Figs, 1 and 2 An appropriately sized coupling attachment 122 is mounted on distal end 5 ! 16 and is placed in conductive contact with a surface 22 of the artificial acetabular cup

20 Conductive contact implies that the coupling attachment 122 and, therefore, the transmitter 120 of the hand-held device i 10 are in sufficient contact, either direct or indirect, with the acetabular cup 20 to emit a signal or beam into the lesion and receive a reflected signal from a boundary 14 between the lesion and the healthy bone of the io acetabulum 10 As discussed above, in some embodiments the acetabular cup 20 facilitates the emission or receiving of signals In other embodiments, the signals merely pass through the acetabular cup 20 In one aspect, the coupling attachment 122 is adapted for conductive contact with the acetabular cup 20 using a coupling medium, such as coupling liquid or other substance In another aspect, the coup! ing attachment 122 is ϊ 5 adapted for di rect contact with the lesion 12 after removal of the artificial acetabular cup

20. Further, in some embodiments the transmitter 120 is adapted for direct contact with the acetabular cup 20 or the lesion 12 In other embodiments, particularly where the osteolytic lesion 12 or other tissue feature is located within the acetabulum 10 or other tissue, the coupling attachment 122 is formed from an appropriate material and shaped to

20 pierce through a portion of the acetabulum to become in direct conductive contact with the osteolytic lesion 20 as shown more fully in U.S. Patent Application Serial No. 11/356,687 filed February 1 7, 2006 incorporated herein by reference.

The transmitter 120 emits an ultrasound signal 130 into the osteolytic lesion 12 through coupling attachment 122 and the acetabular cup 20 The ultrasound signal 130

25 will pass through the lesion 12 until it arrives at the interface between the lesion and healthy bone, illustrated by boundary 14. At that point, a portion of the ultrasound signal 130 will reflect off of the boundary 14. This reflected signal is the echo or return signal 132 that will be received by the system 100 for determining the characteristics of the lesion, including size, volume and shape In one embodiment, based on the time delay of

30 the return signal 132 and the assumed constant speed of the acoustic signal in the lesion, the depth of the osteolytic lesion 12 at various points may be determined by the signal processor. This can be utilized to determine the shape and position of the lesion 12. The δ

signal processor may also utilize this information to determine the volume of the lesion 20 !t should be noted that determining volumetric measurements are intended to include approximations, and estimations of the actual volume as well as precise determinations of volume. Further, the volume estimation may be based on the corresponding amount of 5 bone filler required to fill the void once the lesion is removed, such as a small INFUSE® bone graft kit from Medtronic, lnc or other similar bone growth stimulators, rather than a numerical representation, such as 36 cc.

The reflected signals 132 are used by the signal processor to determine the boundary of the lesion and to determine the volume based on the points defining the lesion id boundary In one embodiment, the boundaries are compared to one or more known geometric shapes of known volume to determine the best fit and thereby determine the best approximation of the volume of the lesion. For example, but without limitation to other shapes, the geometric shapes include spheres, cylinders, cubes, pyramids and cones. Further, more than one shape of different sizes may be used to approximate the lesion ϊ5 shape and volume For example, a series of small cubes may be stacked in virtual space within the \ oid boundaries to closely approximate the actual sensed \ olume. hi one embodiment, the volume determination is made by the surgeon based upon the boundaries of the lesion. In another embodiment, the signal processor calculates both the boundaries and the volume of the lesion 12.

20 In some embodiments the transmitter 120 first emits a broad signal that travels into a wide area of the acetabulum H) Then based upon the reflected signal from the broad signal, a narrower signal is focused upon an area where indicators of an osteolytic lesion were detected This process is iterated until a beam of appropriate size is transmitted to detect the features of the osteolytic lesion. Where multiple lesions are detected the signal

25 may focus upon one lesion at a time, repeating the process for the additional lesions after obtaining features of the first lesion. Focusing the signal on a specific location may be automatically performed based on calculations performed by the signal processor, manually performed by the operator, or a combination of the two For example, the operator may utilize a 3-D display, discussed below, to identity generally the presence of a

30 lesion and then focus the signal to obtain more information about the lesion such as its size, shape, and density. In these ways, the system 100 may focus in on the osteolytic lesion to obtain the most precise data and information available Further, in other aspects, 9

the user moves the location of transducer 120 to various points in three dimensional space and the processor determines volume and boundaries of the lesion based on the difference in reflected signals from the plurality of locations In a further embodiment, the user applies a compressive force to the hand held probe that is transmitted to the bone and the 5 lesion. A first ultrasonic reading is taken with the hand held probe or other tool compressing the bone and/or lesion with a first pressure. A second ultrasonic reading is taken with the hand held probe or other tool compressing the bone and/or lesion with a second pressure. The first and second ultrasonic readings are compared and the difference in the sensed characteristics under varying pressure is utilized to create at least a portion of

10 a 3-D model representing the lesion. In still a further embodiment, a plurality of coupling attachments are provided with different surface contact areas. The user initial starts with a large surface contact coupler for the general ultrasonic survey of the area of interest. The user then selects a coupler having a smaller surface contact area, much less than the surface area of the implant such as shown in Fig. 1 , and applies the coupler to the area of

15 interest. If still further more detailed information is desired, a still smaller contact surface area coupler may be attached to the hand held probe and utilized to interrogate the lesion. lii some embodiments, the system 100 is used to create a 3-D image or model of the osteolytic lesion and surrounding bone from which the lesion may then be evacuated. The 3-D image may be viewed by the surgeon on the display 150 A second reading may

20 be taken after debridement of the lesion. Then, based on the second reading, any remaining lesion may be identified and removed In this way, the system 100 not only allows the physician to determine if any lesion remains, but also know precisely where any unwanted tissue remains This process can be iterated until the lesion is completely removed. This process allows for successful removal of all of the undesirable tissue,

25 which in the case of osteolytic, lesions has been difficult to determine in the past.

Where the electronic instamientation 100 is utilized to check for the complete removal of the lesion 20 after debridement, a coupling media or filler material is used to fill the void For example, in one embodiment the void is filled with a saline solution or other conductive substance such that the electronic instrumentation 100 may detect the 30 boundaries between the saline and the lesion 20 to determine if the lesion has been fully removed. In one embodiment, the coupling media is a fϊowabie material with known acoustic properties that are easily distinguishable from the lysis and surrounding bone 10

For example, but without limitation to other materials, the coupling media includes saline solution, blood, plasma, bone paste, bone wax, allograft, autograft, demineralized bone, BMP in a carrier matrix, mineralized granules, and bone cement. In an additional aspect, the system 100 is used to detect proper packing of the completely debrided void 5 with bone filler material disposed between the bone filler material and the boney boundary To this end the system may detect any remaining voids or the presence of foreign materials- such as the filler materials in comparison to the original lesion.

Alternatively, for less defined lesion boundaries, reflected energy signals are processed to determine a gradient profile for the transitional tissue between the healthy io bone and the homogenous lesion material to determine bone integrity or condition information from the reflected signals is used to by the health care provider to determine the extent of debridement desired for a successful procedure, In one embodiment the system evaluates the boundary of the lesion to determine the gradient between the natural healthy tissue well outside the lesion, the substantially homogenous lesion material, and ϊ5 the transitional tissue of potentially compromised tissue extending between the lesion and the healthy tissue, hi one form, the processor is programmed to select a debridement and volume boundary where the transitional tissue gradient is between 100% and 50% healthy tissue In another form for cancerous lesion removal, the processor is programmed to set the debridement boundary so it includes a buffer of healthy tissue outside of the sensed

20 lesion boundary to ensure that all of the cancerous and precancerous cells are removed.

The system 1 (XJ includes a display 150 Depending on the type of data being obtained by the system 100 the display i 50 may take on different forms Where the system 100 is configured to create 3-D models of the tissue and lesion the display 150 must have sufficient resolution to show the details of the image. Thus, where 3-D images

25 are utilized the display 150 may be a computer monitor, television, projector, or other display with sufficient output capabilities. In some embodiments, the system 100 will be adapted to create 3-D models of the tissue and the display 150 is adapted accordingly. In such cases, the 2-D images may be derived from the 3-D models In some embodiments, views of a 3-D model will not be required arid therefore the display 150 may have much

30 lower resolution. For example, if the display 150 is adapted to show the estimated size of the lesion, such as "36 cc," a small liquid crystal display may be sufficient. Without 1 1

limitation to detecting smaller or larger lesions. it is contemplated that the system 100 detects lesion sizes ransins from 5 cc - 100 cc.

In some embodiments, it will not be necessary' for the display 150 to show even the volume of a lesion In those situations, the system 100 and the display 150 are adapted to 5 show an indication of the general size of the lesion, such as small, medium, large, or extra large. Each size will have a corresponding range of volumes and possibly an associated surgical kit based on the amount of grafting material required in such a case, the display 150 may be adapted to show a color, an appropriately sized bar, or a letter (e.g. S, M, L, or XL) corresponding to the size of the lesion Thus, there are numerous simple visual id displays that may be used to indicate the size or other data obtained by the system 100 In addition, in one embodiment the system 100 does not include a display.

In lieu of or in addition to display 150, alternative embodiments of the system include other means of outputting tissue data in human intelligible form For example, in one embodiment the system includes an audible output, such as a speaker, adapted to 15 provide information to the caretaker In one embodiment the audible output beeps or otherwise indicates the genera! size of the lesion or other tissue roalfoimity. Other human intelligible forms, such as vibrations, are also contemplated as means of outputting tissue data

In one embodiment the system may classify the size of the lesion based on a kit 20 size related to the amount of grafting material — such as autograft, allograft, osteoinductive, or osteoinductive materials needed to fill the lesion. For example, but without limitation, in one embodiment the void is filled with a mixture of bone morphogenic protein (BMP) carrier matrix and mineralized granules. The carrier is a collagen sponge or paste including bi-caSciuni phosphate. The BMP may be included in a 25 platelet gel or may be recombinant BMP. The mineralized granules are a homogenous substance or mixture of autograft, allograft, xenograft, hydroxyl appetite, bi-calcium phosphate, coral or other materials suitable for implantation In one aspect a small kit w ould be a small INFUSE® bone graft kit from Medtronic, Inc. containing a 2.5 mm collagen sponge and a vial of BMP to reconstitute in solution of 1.5 mg/ml of saline 30 solution A medium INFUSE® bone graft kit would contain a 5 6 mm collagen sponge and a larger vial of BMP. while a large INFUSE® bone graft kit would contain an 8 0 mm 12

collagen sponge and a larger vial of BMP to reconstitute a solution at 1 5 mg/ml of saline solution

As shown in Fig. 1 , the hand-held device 1 10 is wired by cable 1 15 to processor 140, which in tern is connected to the display 150 This wired communication is utilized 5 to transfer data from the hand-held device 1 10 to the display 150 and signal processor. In some embodiments the hand-held device 1 10 is adapted for wireless communication with the signal processor 140 and display 150 In this regard, the hand-held device 1 10 is configured to transfer data using RFID, inductive telemetry, acoustic energy, near infrared energy, "Bluetooth," or computer networks The hand-held device U O transfers data to id offload tasks such as the computing performed by the signal processor, displaying the data, or storing the data. This is particularly true where the signal processor and the display are part of a computer system or other apparatus specifically adapted for processing, storing, and displaying the information. The hand-held device 1 10 also includes a memory and a port for transferring data in one embodiment. In such an ϊ5 embodiment, the hand-held device 1 tO may be utilized to obtain data and then selectively connected to the signal processor or display.

The wired communication is also utilized to provide power to the hand-held device 1 10 In one aspect, the hand-held device 1 10 receives power via a Universal Serial Bus ("USB" } system. In this way the hand-held device 1 10 may be adapted to communicate 20 over a USB cable with the signal processor and display so as to both receive power and transmit data. In this w ay, the hand-held device 100 utilizes the external device to receive power, perform the signal processing, store data, and display information. Thus, the external device may be handheld device such as a cell phone, PDA₅ or similar type device as well as a laptop or desktop computer.

25 In an alternative embodiment the hand-held device 1 10 is adapted to receive power from an external source dedicated solely to providing power. For example, the hand-held device 1 10 receives power from a wall socket or other common power source through a wired connection in some embodiments To this end, the hand-held device 1 10 may itself include a wire adapted to plug into the pow er source. On the other hand, the hand-held

30 device 1 10 may include an adapter or receiver for selectively connecting to a wired power supply, such that the instrumentation is not permanently attached to the wire. In one embodiment, the power supply of the hand-held device 1 10 is an internal power source 13

That is, the power supply is fully disposed within the hand-held device 1 10 In such an embodiment, the internal pow er source is a battery or a plurality of batteries

It is fully contemplated that the hand-held device 1 10 he configured to include as few parts as needed, utilizing the features of external devices to the full extent possible 5 This can be very beneficial where the hand-held device 1 10 is adapted to he disposable such that cost is kept to a minimum. In at least one embodiment the coupling attachment 122 is disposable so that the coupling attachment is discarded after each use and the remaining portions of the hand-held device 1 10 and system 100 are reusable. In other embodiments the entire hand-held device UO is disposable. That is, the hand-held device io i 10 is designed for use in only one røedica! procedure or for a limited amount of time. For example, in one aspect the hand-held device 1 10 includes a circuit that breaks or disconnects if the instrumentation is subjected to autoclaving or other types of sterilization procedures. The hand-held device 1 10 may also include a batten¹ with a predetermined life For example, the battery may be designed to provide power to operate the hand-held ϊ5 device 1 10 for 12 hours after initiation. This would give the hand-held device sufficient power for long surgical procedures, yet limit the useful life of the instrumentation to a single procedure

Further, the data from the system 100 may be transmitted to an image guided surgery (IGS) system such that the data concerning the tissue properties and Ihree- 20 dimensional void boundaries may be integrated with the positioning data of the IGS system. Thus, a composite three-dimensional model showing the tissue type and/or void boundaries is calculated and may be displayed separately or as part of a composite image with the IGS display The data from the system 100 may be transmitted wirelessly or by wired communication, or through a data storage device to the IGS system.

25 In a further embodiment, the system 100 itself is a component of an ΪGS system, in this embodiment, the system 100 is utilized to map the three-dimensional void boundaries and the three-dimensional location of the lesion relative to the patient^'s body The IGS system then guides the user to remove all or substantially all of the lesion based on the sensed data. In an alternative embodiment, the IGS system includes an automated

30 bone removal device in communication with the IGS system. The automated bone remov al device is advanced to the lesion site under computer control, activated to remove the lesion under computer control, and removed from the lesion site In a further 14

embodiment, the IGS system automatically locates the lesion void after debridement and fills the void with a filler materia! . Finally, in another embodiment a sensor is placed in the filler material to verify complete filling of the void.

Though the system 100 has been described primarily in connection with detecting 5 the size of lesions in bone and determining whether removal of the lesion was successful the system according the present invention has many other applications In one application., the system i00 is used after filling of the void with bone fil ling material to evaluate completeness of the filling. For example, the difference in materia! properties between the native bone, the bone filler and any substance left in the void can be sensed id by the system i 00 If a foreign substance, such as blood, air, saline solution Jesion, tumor, etc., remains after filling the void the system can detect it, display the information, and alert the user. In another application, the system 100 is configured to determine the actual density of tissue, rather than simply distinguishing between different types of tissue This may be particularly advantageous in the treatment of patients with osteoporosis.

15 Although lesion has often been referred to in regards to an osteolytic lesion, lesion is intended to include any type of abnormal tissue, malformation, or wound related to a bone or other tissue, including cancers, voids, tumors, missile injuries, projectiles, puncture wounds, fractures, etc. For example, in some embodiments the disclosed system is useful to detect and determine the size of bone cancer voids, cancer cells, and tumors. Further,

20 the system is also adapted to detect the presence of healthy tissue as well Thus, the electronic instrumentation is adapted to determine the shape and volume of tissue features, both good and bad.

In another aspect, the system is used to remotely probe suspect tissue and alert the user to the presence of anomalous tissue based on reflected energy indicating different

25 densities. In still a further aspect, the system is used to monitor the growth and healing of soft tissues in 3-D space, such as tendons and ligaments, as well as bone. In yet a further embodiment, the system is utilized to detect the location in 3-D space of foreign bodies, such as bullets, nails, glass, or other objects, in various types of tissue and particularly- associated with penetration wounds. In one embodiment, the features of the hand-held

30 device are combined with a grasping instrument such that the detected foreign bodies may be located, grasped by the instrument, and withdrawn from the patient. 15

Finally, the electronic instrumentation may be configured to perform a plurality of the various applications described above in combination Specifically, the system may include two or more of the previously described features.

The foregoing outlines features of several embodiments so thai those skilled in the art may better understand the aspects of the present disclosure. Those skilled in the art should appreciate thai they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes anchor achieving the Mime advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions and alterations herein without departing from the spirit and scope of the present disclosure.

Claims

16

WH VT IS CLAIMED IS:

1 A coupling apparatus for use v\ ith an ultrasonic probe in evaluation of a lesion of a bone having an aiufidai implant comprising

5 a coupling attachment having a body formed of an ultrasonic conductive material, said body ha\iπg an internal \s aJ1 defining a cavity adapted to receiv e a portion of the ultrasonic probe and an external surface, w herein ^aid externa! surface is configured to engage a substantial portion of the artificial implant

id 2 Hie apparatus of claim K wherein the artificial implant is an acetabular cup

3 The apparatus of claim I . wherein said coupling attachment mates with a handheld ultrasound device for detecting indicators of a lesion

ϊ5 4 The apparatus of claim >, wherein the hand -held ultrasound de\ ice removably mates with the coupling attachment

5 The apparatus of claim 4, wherein the coupling attachment is disposable

20 6 The apparatus of claim 3, wherein at least a portion of the surface of the coupling attachment is malleable to conform to the implant

7 The apparatus of claim 3, wherein the artificial implant has an internal socket and said external surface of the coupling attachment is sized to mate with a specific size socket

25 of the artificial implant

8 The apparatus of claim 6, wherein the malleable surface of the coupling attachment is adapted for conductive contact with the artificial implant

>o ^c> The apparatus of claim 8. wherein the artificial implant is adapted to transmit or receive ultrasound signals when in conductive contact with the coupling attachment 17

SO, The apparatus of claim 8, further including a flowable coupling media, wherein the conductive contact between the coupling attachment and the artificial implant is facilitated by a coupling media.

5 1 1 , The apparatus of claim 10, wherein the coupling media is a liquid.

12. The apparatus of claim 7, further including a plurality of coupling attachments of varying sizes.

K) 13, The apparatus of claim 3, wherein a portion of the hand-held ultrasound device is disposable.

14. A system for providing visual feedback of a lesion of a bone, comprising:

15 a hand-held ultrasound device adapted to transmit a signal into a bone, receive reflected signals indicative of inconsistency in the bone and produce a corresponding output signal; a processor in communication with said hand-held ultrasound device and adapted to receive said output signal, said processor configured to formulate a 3-D model of the 20 lesion based on the output signal, said processor providing a display signal; and a display device in communication with said processor and responsive to said display signal to display at least one view of the 3-D model of the lesion.

15. The system of claim 14, wherein the processor is further configured to calculate a 25 volumetric measurement of the lesion.

16. Hie system of claim 1 5, wherein the display is adapted for displaying the volumetric measurement

30 ϊ 7. The system of claim 14, wherein the ultrasound device is further adapted to determine a location of a surgical instrument relative to the lesion. 18

S 8 The system of claim 17, wherein the display is adapted to show the relative location of the surgical instrument to the lesion

19 The system of claim 18. further including an image guided surgery s> stem adapted 5 to guide the surgical instrument to the lesion based upon the location of the surgical instrument relative to the lesion

20 The system of claim 28. wherein the surgical instalment is adapted to remove at least a portion of the lesion

10