WO2009100200A1

WO2009100200A1 - Devices, systems and methods for creating a surgical plane in a vertebral body

Info

Publication number: WO2009100200A1
Application number: PCT/US2009/033192
Authority: WO
Inventors: Kieren Murphy
Original assignee: Vexim Sas
Priority date: 2008-02-08
Filing date: 2009-02-05
Publication date: 2009-08-13

Abstract

Methods and devices for cutting a cleft within a vertebral body, which then can be used to receive an expandable device to restore and/or stabilize the height of the vertebral body, are described. The methods and devices can be implemented by creating a bi-lateral opening in each side of a vertebra, establishing a curved passage within the body of the vertebra connecting the bi-lateral passages to one another, directing a flexible cutting device through at least one of the openings and curved passage, such that a cutting surface of the cutting device may cut material located between the two bi-lateral passages, cutting the material located between the two bilateral passages with the cutting device to create a cleft, e.g., a surgical plane/area, removing the cut material from the vertebral body; and removing the cutting device. Thereafter, the height of the vertebra can be restored by expanding an expansion device within the cleft.

Description

DEVICES, SYSTEMS AND METHODS FOR CREATING A SURGICAL PLANE IN A VERTEBRAL BODY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to United States Provisional Application Serial No. 61/065,143 filed February 8, 2008, which is herein incorporated by reference in its entirety.

FIELD

[0002] Methods and devices described herein relate generally to the field of medical devices. More particularly methods, systems and devices described herein may be used to create a surgical plane (e.g., a cavity, a cleft) within a vertebral body, which may be used to implant an expandable device or material for restoring a height of a vertebra.

BACKGROUND

[0003] A vertebra is an individual irregular bone in the spinal or vertebral column. Vertebral compression fracture is an injury that can take place, inter alia, due to osteoporosis. FIG. 2A-2B illustrate a comparison of a normal vertebra shape (FIG. 2A) to a healed wedge-shaped compression fracture of a vertebra shape (FIG. 2B). There are several vertebra height restoration techniques.

[0004] Wedge shaped fractures similar to the one illustrated in FIG. 2B may not respond to current height restoration techniques that primarily directed toward creating a cleft (may also be referred to as a void) in the body of the vertebra. Examples of height restoration techniques include verteplasty, which includes a particularly well known procedure called "Kyphoplasty", involving the use of an inflatable balloon (Kyphon, Inc.). Kyphoplasty is designed to stop the pain caused by the bone fracture, to stabilize the bone, and to restore some or all of the lost vertebral body height due to the compression fracture. Using the Kyphoplasty procedure, the original height and angle of kyphosis of a fractured vertebra can be restored. The fractured vertebra can also be stabilized using injected bone filler material. Height and angle restoration techniques currently involve either hydraulic or mechanical intravertebral expansion.

[0005] Other expandable devices are also known which are placed within according to an unexpanded configuration, then expanded to a second configuration, which is used to either stabilize and/or move cortical bone to restore bone height.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 illustrates an exemplary method for restoring the height of the vertebra according to some embodiments of the present disclosure.

[0007] FIG. 2A - 2B illustrates a comparison of a normal vertebra shape to the healed wedge- shaped compression fracture of a vertebra.

[0008] FIGs. 3A-B illustrate exemplary bi-lateral insertion of a trans-pedicular, hollow needle using a standard steel Murphy style needle in each side of the vertebra according to some embodiments of the present disclosure.

[0009] FIG. 4A illustrates introduction of a guidewire into the vertebra according to some embodiments of the present disclosure.

[0010] FIG. 4B illustrates one example of a saw element attached to a guidewire according to some embodiments of the present disclosure.

[0011] FIG. 5A illustrates an exemplary insertion of the saw element into the body of the vertebra according to some embodiments of the present disclosure.

[0012] FIG. 5B illustrates the beginning of the removal of at least one of the hollow, flexible (which may be shape-memory) needles (preferably both), such that the saw element, after removal of the flexible needle(s) is now ready to cut material within the body of the vertebra, according to some embodiments of the present disclosure. [0013] FIG. 6 illustrates an exemplary withdrawal of the nitinol needles according to some embodiments of the present disclosure.

[0014] FIGs. 7A-B illustrate back and forth movement of the saw element through the Murphy needles according to some embodiments of the present disclosure.

[0015] FIGs. 8A-B illustrate creation of a plane within the body of the wedge-shaped vertebra according to some embodiments of the present disclosure.

[0016] FIG. 9 illustrates an exemplary removal of the saw element according to some embodiments of the present disclosure.

[0017] FIG. 1OA illustrates an exemplary removal of the Murphy needles according to some embodiments of the present disclosure.

[0018] FIG. 1OB illustrates restoration of the height of the vertebra by an expansion device according to some embodiments of the present disclosure.

[0019] FIG. 11 illustrates an exemplary method for creating a cleft according to some embodiments of the present disclosure.

SUMMARY OF THE EMBODIMENTS

[0020] Systems, methods and devices for establishing a cleft or plane in a bone for incorporation of a device or method for restoring the height of a vertebra are provided. In some embodiments, the cleft/plane can be created by inserting a flexible cutting element into a vertebra, cutting a cleft within the vertebra by moving the flexible cutting element. The created cleft/plane can then be used to house a device for restoring the height of the vertebra (e.g., an expandable device).

[0021] Throughout the present disclosure it is noted that where the term "needle" is used, that such an element may also comprise a cannula having an appropriate size and configured to accomplish the functionality required of it. Thus, one or more of the transpedicular needles may comprise a transpedicular cannula, and one or more of the flexible, shape-memory needles may comprise a flexible cannula of similar size and configuration to carry out the necessary functionality.

[0022] For example, the flexible cutting element can be inserted through a transpedicular needle positioned in a side of the vertebra. The flexible cutting element can also be inserted into a shape-memory (and preferably flexible) hollow needle or cannula (flexible "needle" or "cannula"), the shape-memory hollow needle can be inserted into a transpedicular needle positioned in a side of the vertebra. The flexible cutting element can be attached to a guidewire, and, the flexible cutting element can be inserted into the vertebra by threading the guidewire through the shape-memory hollow needle. In some embodiments the cleft can be created (e.g., cut) by moving the flexible cutting element back and forth and removing debris. For example, the debris can be removed by using a liquid. Preferably, the flexible, shape-memory needles are removed prior to movement of the cutting element (at least one of the shape-memory needles are removed, and preferably both).

[0023] In some embodiments, the flexible cutting element can be inserted into the bone by inserting two transpedicular needles into each side of the vertebra, inserting two shape-memory hollow needles into the two transpedicular needles, inserting a guidewire into the two shape- memory hollow needles, where an end of the guidewire is attached to the cutting element, and pulling the guidewire to inset the flexible cutting element into the vertebra.

[0024] For example, a first of two shape-memory hollow needles can comprise a first proximal end and a first remote end, a second of the two shape-memory hollow needles can comprise a second proximal end and a second remote end, and the first and the second needles can be inserted such that the first remote end is facing the second remote end. The guidewire can be pulled consecutively through the first proximal end, the first remote end, the second remote end and the second proximal end.

[0025] In some embodiments, the two transpedicular needles may be inserted using a fluoroscopy. Moreover, in some embodiments, the flexible cutting element can be a saw, and may also be a wire with a cutting surface.

[0026] A system (e.g. a kit) for creating a cleft in a vertebral body can also be provided. The system can comprise two transpedicular needles for insertion into a vertebra; two shape-memory alloy needles for insertion into the corresponding transpedicular needles, wherein the ends of the shape-memory needles are configured to face one another within the vertebral body; and, a guidewire for insertion into the two shape-memory alloy needles, wherein the guidewire is coupled to a flexible cutting element.

[0027] Some embodiments of the present disclosure are related to a method for establishing a cavity within a vertebral body comprising: inserting a first hollow needle or cannula transpedicularlly via a first pedicle of a first side of a vertebral body; inserting a second hollow needle or cannula transpedicularlly via a second pedicle of a second side of the vertebral body; inserting a first flexible cannula or needle within the first hollow needle; inserting a second flexible cannula or needle within the second hollow needle, wherein the distal ends of the first and second flexible cannulas meet within the vertebral body; inserting a flexible cutting element within either the first or second flexible cannula, wherein a first end of the flexible cutting element can be guided from the distal end of the first flexible cannula into the distal end of the second flexible cannula; the first end of the cutting element can be guided through the second flexible cannula, such that, a gripping area for each end of the cutting element can be provided outside of proximal ends of both the hollow needles and flexible cannulas is established; removing at least one of the flexible cannulas from the respective hollow tubes; applying a tensile/pulling force to at least one end of the cutting element such that cancellous bone interacting with the cutting element within the interior of the vertebral body is cut and results in the establishment of a cleft of predetermined height within the vertebral body.

[0028] In some embodiments the method can further comprise threading a guidewire through the first flexible cannula, wherein as a result of such threading, the guidewire is threaded entirely through both flexible cannulas, and wherein, one end of the guidewire is removable affixed to an end of the cutting element, allowing the cutting element to be placed from one flexible cannula to the other.

[0029] In some embodiments, both the first and second flexible cannulas can be removed from their respective hollow needles. A fluid can be injected into one of the hollow needles to flush out cut bone and other debris from within the vertebral body as a result of movement of the cutting element. [0030] Some embodiments of the present disclosure are related to a bone cavity cutting system (which may be a kit) for establishing a cavity within a vertebral body comprising: a first hollow needle or cannula for transpedicular placement via a first pedicle of a first side of a vertebral body; a second hollow needle or cannula for transpedicular placement via a second pedicle of a second side of the vertebral body; a first flexible cannula or needle for placement within the first hollow needle; a second flexible cannula or needle for placement within the second hollow needle, wherein the distal ends of the first and second flexible cannulas are configured to meet within the vertebral body; a flexible cutting element, wherein a portion of the cutting element is placed for placement within either the first or second flexible cannula, wherein a first end of the flexible cutting element is configured to be guided from the distal end of the first flexible cannula into the distal end of the second flexible cannula; and the first end of the cutting element is configured to be guided through the second flexible cannula, such that, a gripping area for each end of the cutting element is provided outside of proximal ends of both the hollow needles and flexible cannulas is established; and wherein upon removal of at least one of the flexible cannulas, a tensile/pulling force applied to at least one end of the cutting element cuts cancellous bone interacting with the cutting element within the interior of the vertebral body and results in the establishment of a cleft of predetermined height within the vertebral body.

[0031] In some embodiments the system can further comprise a fluid flushing component configured to inject fluid in one of the hollow needles to flush out bone and other debris created by the cutting element.

DETAILED DISCLOSURE

[0032] Systems, methods and devices for creating a cleft having a predetermined height or plane of predetermined height (hereinafter referred to as either a "cleft" or "plane" or "surgical plane"), or of predetermined shape and size, are provided. The methods and devices can be used for enabling the restoration of the height of a vertebral body via verteplasty techniques. In some embodiments, the cleft can be created by inserting a flexible cutting element into a vertebral body, and cutting away at the cancellous bone within the vertebra by moving the flexible cutting element, preferably back and forth (e.g., in at least one preferably two directions). The height of the vertebra may then be restored by inserting and expanding an expandable device within the cleft. [0033] FIG. 1 illustrates an exemplary method 100 for some embodiments of the present disclosure. At 110, a flexible cutting element (e.g. a saw) can be inserted into the body of the vertebra. At 120, the flexible cutting element can be used to cut out a cleft. At 130, an expandable device can be inserted within the cleft which can be expanded to restore (and/or stabilize) the height of the vertebra.

[0034] FIG. 3A illustrates a vertebra 300 and two needles 310 and 320. The vertebra 300 can be an individual irregular bone in a flexuous and flexible column that is a defining characteristic of vertebrate animals and humans. The needles 310 and 320 can be stainless steel needles (for example). The needles 310 and 320 can also be Murphy type needles. In some embodiments, the needles 310 and 320 can be inserted using the fluoroscopy technique. Fluoroscopy is an imaging technique that can obtain real-time moving images of the internal structures of a patient through the use of a fluoroscope.

[0035] Fig. 3B illustrates two transpedicular, hollow needles 310 and 320 which may be inserted bi-laterally in each side of the vertebra 300. FIG. 3B also illustrates two needles 330 and 340, which are preferably flexible, and which may be made of a shape-memory material (e.g., nitinol). The needles 330 and 340 can be hollow, and, in some embodiments, the needles 330 and 340 can be inserted using the two trans-pedicular hollow needles 310 and 320.

[0036] Fig. 4A illustrates two memory-shaped needles 450 and 460, which may include a curved shape, two transpedicular, hollow needles 420 and 430, and, a guide wire 410. In some embodiments, the memory-shaped needles 450 and 460 can be nitinol needles. The needles 450 and 460 can be introduced through the inserted vertebra needles 420 and 430, and preferably positioned until the tips of the nitinol needles 420 and 430 meet within the body of the vertebra being treated. Each of the nitinol needles 420 and 430 are preferably hollow. A guide wire 410 may be introduced into the vertebra, preferably through one of the inserted Murphy/nitinol needle combination, and threaded through the tips of the adjacently positioned nitinol needles. Preferably, the gauge of the guidewire can be approximately between 0.018 - and about 0.038 inches (e.g., 0.018, 0.022, 0.035 and 0.038). Other gauge guide wire may also be used, depending upon the circumstances and the method being used and the design.

[0037] FIG. 4B illustrates an embodiment of the disclosure comprising a guide wire 480 and saw element 470. The end/tip 460 of the guidewire 480 can be hollow, similar to a coronary TAD guidewire provided by the TAD Guidewire Systems and Mallinckrodt Corporation

herein incorporated by reference). The end of the guidewire 460 can be detachably attached to the end 465 of the saw element 470. For example, the guidewire 480 can be used to insert the saw element 470 inside a vertebra. The guidewire can subsequently be withdrawn from within the vertebral body and detached from the saw element 470. In other embodiments, the guidewire can remain attached to the saw element throughout the procedure. The guidewire can also be used to extract the saw element from the body of the vertebra.

[0038] FIG. 5A illustrates an exemplary insertion of the saw element into the body of the vertebra. The saw element 550 is attached to the guidewire 510. The guidewire 510 is threaded through the memory-shaped needles 520 and 570. The memory shaped needles 570 and 520 are, in turn, threaded through the hollow needles (e.g. Murphy needles) 560 and 530 respectively. FIG. 5B illustrates the saw element 540 positioned inside the vertebra, for example, by pulling the guidewire 510.

[0039] FIG. 6 illustrates the vertebra 600, the saw element 630 positioned inside the vertebra 600, and, the two memory-shaped needles 610 and 620. FIG. 6 also illustrates that memory- shaped needles 610 and 620 can be withdrawn from the vertebra 600 once the saw element 630 is in place.

[0040] In some implementations, the saw element 630 may be an elongated member, having a circular, rectangular, or triangular cross section (or other cross-sectional shape), which includes, for example, serrations along a portion of its surface. For example, if the saw element 630 had a rectangular cross section, the surface of one of the longer sides may include such serrations (alternating height, sharpened areas, e.g., teeth). The saw element may be positioned such that the "saw" surface faces the pedicle portions of the vertebra.

[0041] In some embodiments, the "blades" of the saw element 630 may be positioned close enough so that the saw element may be easily removable from within the vertebral body. In one such embodiment, the saw element 630 may be a wire-saw, where wire is notched, to create a cutting surface. The wire can be strong enough so that the notches can cut/break through cortical bone. [0042] FIGs. 7 A - B illustrates back and forth movement of the saw element 720 through the Murphy needles 730 and 740. The movement of the saw element 720 may create a plane 750 (e.g., a cleft) within the body of the wedge-shaped vertebra 700. As vertebra's material is dislodged, it can be carried into one or the other of the Murphy needles 730 and 740. As the teeth of the saw element 720 slide out one or the other of the Murphy needles, cut material trapped by one or more of the teeth can move out of the proximal end of the corresponding Murphy needle, where it can fall and be collected. A liquid solution (e.g., saline) may be used to loosen debris (e.g., cut cancellous bone, blood, marrow, and the like) off of the saw teeth to speed up removal of the material as the saw teeth are positioned outside of the Murphy needles.

[0043] FIGs. 8A-B illustrate creation of the surgical plane 810 within the body of the wedge- shaped vertebra 800 using the saw element . In some embodiments, a determination can be made that the cavity/cleft in a plane within the body of the vertebra has been created based on either occurrence of minute particles of debris and/or the lengthening of the length of the saw element outside of the Murphy needles. The adequacy or completeness of the cleft or cavity may be determined to be substantially complete upon a lack of debris coming off of the saw element.

[0044] FIG. 9 illustrates a removal of the saw element 920 from the vertebra 900. FIG. 9 also illustrates the plane 910 created using the saw element 920. In some embodiments, the saw element 920 can be removed by angling the Murphy/verteplasty needles so that the edges of the particular needle does not come into contact with the teeth of the saw element 920. The Murphy needles 930 and 940 may subsequently be removed from the vertebra.

[0045] 1OA illustrates an exemplary removal of the Murphy needles 1030 from the vertebra 1000. FIG. 1OA also illustrates the cleft 1010 that, in some embodiments, was created by using a saw element. FIG. 1OB illustrates the vertebra, wherein the cleft section 1020 has been expanded in order to adjust the angle of the upper portion of the vertebra 1050, thereby restoring the height of the vertebra.

[0046] In one implementation, the cleft section 1020 can receive an expandable, implantable device. For example, the devices disclosed in published U.S. patent application no. 20060004455, herein incorporated by reference in its entirety, can be used to restore the height of the vertebra. [0047] FIG. 11 illustrates an exemplary method 1100 for creating a cleft. At 1100, a transpedicular needle can be bilaterally inserted into each side of a vertebra. At 1120, a shape- memory alloy needle can be introduced within each transpedicular needle. At 1130, the ends of the shape-memory needles can be directed toward one another within the vertebral body. For example, the ends can be directed such that the ends are positioned adjacent one another. At 1140, a guidewire can be threaded through the shape-memory alloy needles. For example, the guidewire can be threaded such that an end of each shape-memory alloy needle positioned outside the vertebral body corresponds to an end of the guidewire. At 1150, a flexible saw can be attached to one end of the guidewire. At 1160, the saw can be directed within the vertebral body using the guidewire, and a portion of the vertebra can be cut using the saw. The saw can be moved relative to the body of the vertebra such that material from within the vertebral body is cut. This is preferably accomplished with at least one of the shape-memory needles/cannulas removed, and may also be accomplished by removing one or more of the transpedicular needles/cannulas. At 1170, the cut material and the saw can be removed from the vertebral body. Consequently, an expandable device can be expanded within the created cleft in order to restore the height of the vertebra.

[0048] It will thus be seen that embodiments of the present disclosure attain objects made apparent from the preceding description. Since certain changes may be made without departing from the scope of the present disclosure, it is intended that all matter contained in the above description or shown in the accompanying drawings be interpreted as illustrative and not in a literal sense (and thus, not limiting). Practitioners of the art will realize that the method, device and system configurations depicted and described herein are examples of multiple possible system configurations that fall within the scope of the current disclosure.

[0049] While the disclosure has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the disclosure. All such modifications are intended to be within the scope of the claims appended hereto.

Claims

What is claimed is:

1. A method for restoring a height of a vertebra comprising: inserting a flexible cutting element into a vertebra, cutting a cleft within the vertebra by moving the flexible cutting element; and restoring the height of the vertebra by expanding an expandable device within the cleft.

2. The method of claim 1, wherein the flexible cutting element is inserted through a transpedicular needle positioned in a side of the vertebra.

3. The method of claim 1, wherein the flexible cutting element is inserted into a shape- memory hollow needle, the shape-memory hollow needle is inserted into a transpedicular needle positioned in a side of the vertebra.

4. The method of claim 3, wherein the flexible cutting element is attached to a guidewire, and, wherein the flexible cutting element is inserted into the vertebra by threading the guidewire through the shape-memory hollow needle.

5. The method of claim 4, wherein the cleft is cut by moving the flexible cutting element back and forth and removing debris.

6. The method of claim 5, wherein the debris are removed by using a liquid.

7. The method of claim 1 , wherein the flexible cutting element is inserted by: inserting two transpedicular needles into each side of the vertebra; inserting two shape-memory hollow needles into the two transpedicular needles; inserting a guidewire into the two shape-memory hollow needles; and pulling the guidewire to inset the flexible cutting element into the vertebra.

8. The method of claim 7, wherein a first of the two shape-memory hollow needles comprises a first proximal end and a first remote end, a second of the two shape-memory hollow needles comprises a second proximal end and a second remote end, and the first and the second needles are inserted such that the first remote end is facing the second remote end.

9. The method of claim 8, wherein the guidewire is pulled consecutively through the first proximal end, the first remote end, the second remote end and the second proximal end.

10. The method of claim 1, wherein the expandable device comprises plastically deformable implant.

11. The method of claim 9, wherein the two transpedicular needles are inserted using a fluoroscopy.

12. The method of claim 9, wherein the flexible cutting element is a saw.

13. A system for creating a cleft in a vertebral body comprising:

two transpedicular needles for insertion into a vertebra;

two shape-memory alloy needles for insertion into the corresponding transpedicular needles, wherein the ends of the shape-memory needles are configured to face one another within the vertebral body; and

a guidewire for insertion into the two shape-memory alloy needles, wherein the guidewire is coupled to a flexible cutting element.

14. The system of claim 13, wherein the two transpedicular needles are Murphy needles.

15. The system of claim 13, wherein the flexible cutting element is a notched wire comprising a cutting surface.

16. The system of claim 13, wherein the two transpedicular needles are inserted using a fluoroscopy.

17. The system of claim 13, wherein the flexible cutting element is a saw.

18. The system of claim 17, wherein the saw is detachably attached to the guidewire.

19. A method for establishing a cavity within a vertebral body comprising:

inserting a first hollow needle or cannula transpedicularlly via a first pedicle of a first side of a vertebral body;

inserting a second hollow needle or cannula transpedicularlly via a second pedicle of a second side of the vertebral body; inserting a first flexible cannula or needle within the first hollow needle;

inserting a second flexible cannula or needle within the second hollow needle, wherein the distal ends of the first and second flexible cannulas meet within the vertebral body;

inserting a flexible cutting element within either the first or second flexible cannula, wherein

a first end of the flexible cutting element is guided from the distal end of the first flexible cannula into the distal end of the second flexible cannula;

the first end of the cutting element is guided through the second flexible cannula, such that, a gripping area for each end of the cutting element is provided outside of proximal ends of both the hollow needles and flexible cannulas is established;

removing at least one of the flexible cannulas from the respective hollow tubes;

applying a tensile/pulling force to at least one end of the cutting element such that cancellous bone interacting with the cutting element within the interior of the vertebral body is cut and results in the establishment of a cleft of predetermined height within the vertebral body.

20. The method according to claim 19, wherein both the first and second flexible cannulas are removed from their respective hollow needles.

21. The method according to claim 19, where a fluid is injected into one of the hollow needles to flush out cut bone and other debris from within the vertebral body as a result of movement of the cutting element.

22. The method according to claim 19, further comprising threading a guidewire through the first flexible cannula, wherein as a result of such threading, the guidewire is threaded entirely through both flexible cannulas, and wherein, one end of the guidewire is removable affixed to an end of the cutting element, allowing the cutting element to be placed from one flexible cannula to the other.

23. A bone cavity cutting system for establishing a cavity within a vertebral body comprising: a first hollow needle or cannula for transpedicular placement via a first pedicle of a first side of a vertebral body;

a second hollow needle or cannula for transpedicular placement via a second pedicle of a second side of the vertebral body;

a first flexible cannula or needle for placement within the first hollow needle;

a second flexible cannula or needle for placement within the second hollow needle, wherein the distal ends of the first and second flexible cannulas are configured to meet within the vertebral body;

a flexible cutting element, wherein a portion of the cutting element is placed for placement within either the first or second flexible cannula, wherein

a first end of the flexible cutting element is configured to be guided from the distal end of the first flexible cannula into the distal end of the second flexible cannula; and

the first end of the cutting element is configured to be guided through the second flexible cannula, such that, a gripping area for each end of the cutting element is provided outside of proximal ends of both the hollow needles and flexible cannulas is established;

and wherein upon removal of at least one of the flexible cannulas, a tensile/pulling force applied to at least one end of the cutting element cuts cancellous bone interacting with the cutting element within the interior of the vertebral body and results in the establishment of a cleft of predetermined height within the vertebral body.

24. The system according to claim 23, further comprising a fluid flushing component configured to inject fluid in one of the hollow needles to flush out bone and other debris created by the cutting element.