Adjustable drilling device and method of use

Abstract

To provide bone removal tools, for example, a device which can change an effective diameter.SOLUTION: A bone removal device includes: an elongated shaft 102 having a longitudinal axis 107, a distal end 106 and a proximal end 104; a bone borer having a distal drilling tip configured to drill into a bone tissue; and at least one proximal reamer. The bone borer is movably coupled to the distal end of the elongated shaft. The bone borer is configured to move between a drilling state, in which the drilling tip is placed in contact with the bone tissue, and reaming states, in which the at least one proximal reamer is placed in contact with the bone tissue.SELECTED DRAWING: Figure 19A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 713,014, filed August 1, 2018, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] FIELD OF THE INVENTION The present invention relates generally to bone removal tools, such as tools that vary the effective diameter, and particularly to drilling.

[0003] During various arthroscopic procedures, drilling holes is required within the patient's bone. Often, the holes must have various diameters, such as enlarged diameters for one or more of the following surgical procedures: insertion of anchors, administration of drugs, insertion of grafts, and insertion of implants in AVN treatment procedures. Summary of the Invention

[0004] Some examples of some embodiments of the present invention are listed below: Example 1. An elongate shaft having a longitudinal axis, a distal end, and a proximal end; a bone drill having a distal drilling tip configured to drill into bone tissue and at least one proximal reamer; a bone drill tool movably coupled to a distal end of the elongate shaft, the bone drill tool configured to move between a drilling state in which the drilling tip is positioned in contact with bone tissue and a reaming state in which the at least one proximal reamer is positioned in contact with bone tissue. Example 2. The device of Example 1, comprising a pusher element mechanically coupled to the elongate shaft and the bone drill, the pusher element configured to tilt the bone drill relative to the longitudinal axis of the elongate shaft to provide the distal drilling tip in a forward-facing position during the drilling state and to provide the at least one reamer in a radially extending position during the reaming state. Example 3. The apparatus of Example 2, wherein the pusher element is configured to tilt the bone drill at 30 degrees relative to the longitudinal axis of the elongate shaft. Example 4. The device of Example 2 or 3, comprising a rotatable adjuster coupled to the pusher element, the rotatable adjuster configured to rotate between two or more predetermined stop states, each state defining a different angle of inclination of the bone drill relative to the longitudinal axis of the elongate shaft. Example 5. The device of example 4, wherein the rotatable adjuster rotates along an axis different from the axis of rotation of the device.

[0005] Example 6. The device of Example 4 or 5, wherein the rotatable adjuster is configured to rotate about an axis different from the axis of rotation of the bone removal device. Example 7. The apparatus of any one of Examples 4 to 6, wherein the adjuster includes one or more visual indicators for marking the two or more predetermined stop states. Example 8. The device of any one of Examples 4 to 7, wherein the rotatable adjuster includes a plurality of recesses, each of the plurality of recesses corresponding to a single stop state, and the device includes at least one resilient element configured to engage the plurality of recesses. Example 9. The apparatus of Example 8, wherein the adjuster is a disc-shaped adjuster and the plurality of recesses are disposed on at least one sidewall of the disc-shaped adjuster. Example 10. The device of example 8 or 9, wherein the elastic element comprises a leaf spring or a spring plunger.

[0006] Example 11. The device of any one of Examples 2 to 10, comprising a crank having a longitudinal axis, a distal end having two distal protrusions shaped and sized to be pivotally connectable to the bone drill, and a proximal end having two spaced apart protrusions shaped and sized to be pivotally connectable to the pusher element. Example 12. The device of Example 11, wherein the two distal protrusions are angled relative to the longitudinal axis of the crank. Example 13. The device of any one of Examples 1 to 12, comprising a bit connector mechanically coupled to the proximal end of the elongate shaft, the bit connector shaped and sized to connect to an electric or manual drive unit of the device. Example 14. The device of any one of Examples 1 to 13, wherein the elongate shaft includes an opening at the distal end, and the bone drill is movably coupled to the elongate shaft within the distal opening. Example 15. The device of any one of Examples 1 to 14, wherein the movable bone drill is configured to be tilted at an angle of up to 90° relative to the longitudinal axis of the shaft.

[0007] Example 16. The device of any one of Examples 1 to 15, wherein the bone drill extends radially from the elongate shaft at a maximum bevel angle to a distance of up to 6 mm. Example 17. The device of any one of Examples 1 to 16, wherein the length of the elongate shaft between the distal end and the proximal end is in the range of 5 to 30 cm. Example 18. The device of any one of Examples 1 to 17, wherein the maximum width of the elongate shaft is in the range of 1 to 7 mm. Example 19. The device of any one of Examples 1 to 18, comprising a crank having two side walls configured to mechanically couple the bone drill to the elongate shaft. Example 20. The device of Example 19, wherein the crank includes at least two spaced apart, angled protrusions shaped and sized to retain the movable bone tunneling tool against both of the two side walls.

[0008] Example 21. An elongate shaft having a longitudinal axis, a distal end, and a proximal end; a movable bone tunneling tool movably coupled to the distal end of the elongate shaft, the movable bone tunneling tool configured to rotate about the longitudinal axis; a rotatable bone tunnel drill adjuster adjuster coupled to the elongate shaft and the movable bone tunnel drill, the adjuster configured to rotate about an axis different from the axis of rotation of the movable bone tunnel drill. Example 22. The device of Example 21, wherein the axis of rotation of the adjuster is perpendicular to the axis of rotation of the bone removal device. Example 23. The device of Example 21 or 22, wherein the rotatable bone drill adjuster is configured to rotate between a plurality of stop positions, each of the plurality of stop positions defining a respective angle of inclination of the bone drill relative to the longitudinal axis of the elongate shaft. Example 24. The device of any one of Examples 21 to 23, comprising a crank having two side walls configured to mechanically couple the movable bone drill to the elongate shaft. Example 25. The device of Example 24, wherein the crank includes at least two spaced apart, angled protrusions shaped and sized to retain the movable bone tunneling tool on both of the two side walls.

[0009] Example 26. An elongate shaft having a longitudinal axis, a distal end having an opening through said longitudinal axis and intersecting a side surface, and a proximal end; a movable bone drill tool comprising a proximal reamer and movably connected to the distal end and at least partially within the opening; 10. A bone removal device, wherein the movable bone tunnel drill is configured to move between a closed state in which the movable bone tunnel drill closes at least 90% of the opening in the shaft and one or more open states in which the movable bone tunnel drill moves to define a window in at least 10% of the opening. Example 27. The device of Example 26, wherein the opening is shaped and sized to allow bone fragments to move from one side of the shaft through the opening to the opposite side of the shaft during reaming. Example 28. The device of Example 26 or 27, wherein the movable bone tunneling tool includes one or more curved reaming edges at a proximal end of the movable bone tunneling tool configured to contact a bone tissue surface when the movable bone tunneling tool is in the one or more open states. Example 29. The device of Example 28, wherein the one or more curved reaming edges have an angle of less than 45° relative to the bone tissue surface. Example 30. A bone drill of an osteotomy device having a longitudinal axis, a distal end, and a proximal end, at least one forward-facing drilling tip at said distal end having a width of less than 10 mm and shaped and sized to drill into bone; a proximal reamer spaced from said drilling tip shaped and sized to remove bone fragments during reaming.

[0010] Example 31. The bone drilling tool of Example 28, wherein the reamer includes two or more bone-cutting edges, each of the two bone-cutting edges being positioned on opposite sidewalls of the proximal end. Example 32. The bone drill according to Example 31, wherein at least some of the two or more bone cutting edges meet at a single location. Example 33. The bone tunneling tool according to any one of Examples 30 to 32, wherein the maximum width of the distal end of the bone tunneling tool is in the range of 1 to 8 mm. Example 34. An elongate body having a longitudinal axis, a distal end including an opening, and a proximal end; a bone drill movable within the opening; a crank having two side walls configured to mechanically couple the movable bone drill to the elongate body; The crank includes at least two spaced apart projections shaped and sized to retain the movable bone tunnel tool against both of the two side walls. Example 35. The device of Example 34, wherein each of the at least two spaced apart protrusions is attached to a different side wall of the movable bone drill.

[0011] Example 36. The device of Example 34 or 35, wherein the at least two spaced apart protrusions are curved. Example 37. A removable elongate shaft having a longitudinal axis, a distal end, and a proximal end, the shaft including a movable bone drill coupled to the distal end; a bone tunneling tool travel adjuster configured to adjust travel of the bone tunneling tool relative to the elongate shaft; at least one reversible interlocking connector coupled to the elongate shaft and / or the bone drill travel adjuster; The proximal end of the elongate shaft is removably coupled to the bone drill travel adjuster by the at least one reversible interlocking connector. Example 38. The kit of Example 37, wherein the at least one reversible mating connector comprises a snap connector. Example 39. The kit of Example 37 or 38, wherein the removable elongate shaft includes a pusher element coupled to the bone tunnel drill, the pusher element configured to be removably coupled to the bone tunnel drill travel adjuster. Example 40. Drilling a bone using a bone drilling tool of a drilling device to create a bone opening; tilting the bone drill tool relative to the drilling device; reaming the bone opening by rotating the angled bone drill tool.

[0012] Example 41. The method of Example 40, including locking the angled bone drill at a selected angle prior to the reaming. Example 42. Providing a movable cutting tooth and a cutting tooth inclination angle adjuster; aligning the movable cutting tooth and the adjuster in alignment; and operatively coupling said cutting teeth with said adjuster in said aligned position. Example 43. The method of Example 42, wherein the aligning includes positioning the cutting teeth at a selected inclination angle relative to the device, and positioning the adjuster to a selected stop condition while maintaining the cutting teeth at the selected inclination angle. Example 44. The method of example 42 or 43, wherein the operatively coupling includes locking a screw for coupling the cutting tooth to the adjuster. Example 45. Determining the treatment type and / or treatment area; selecting an elongate shaft including a bone drill according to the determined treatment type and / or the determined treatment area; releasably coupling the elongate shaft to a bone drill travel adjuster of the bone removal device.

[0013] Example 46. 46. ​​The method of example 45, wherein the releasably coupling comprises releasably coupling a pusher element that controls a tilt angle of the bone drill to the bone drill travel adjuster. Example 47. The method of example 45 or 46, including decoupling the elongate shaft from the bone punch travel adjuster. Example 48. Determining the treatment type and / or treatment area; selecting an elongate shaft including a bone drill according to the determined treatment type and / or the determined treatment area; and removably coupling the elongate shaft to a bone drill travel adjuster of the bone removal device. Example 49. The method of Example 48, wherein the releasably coupling includes releasably coupling a pusher element that controls the tilt angle of the bone drill to the bone drill travel adjuster. Example 50. The method of example 48 or 49, including decoupling the elongate shaft from the bone drill travel adjuster.

[0014] The present invention seeks to provide an improved adjustable drilling device.

[0015] Thus, in accordance with one embodiment of the present invention, an adjustable drilling device is provided that includes a pusher element disposed along a longitudinal axis and having a proximal end and a distal end, an adjusting element operably attached to the proximal end of the pusher element and having an adjustment path, and a cutting tooth operably and pivotally connected to the pusher element, wherein upon axial displacement of the adjusting element, the pusher element is positionable in a distal operating orientation, thereby causing the cutting tooth to assume an at least partially open operating orientation.

[0016] Preferably, the drilling device also includes a shaft element at least partially surrounding the pusher element. More preferably, the cutting teeth are disposed distally relative to the shaft element. More preferably, the adjustment element is operably engageable with an adjustment retainer, such as a plunger element, thus defining a range of radial extension of the cutting teeth relative to the shaft element. More preferably, the axial displacement of the adjustment element is biased by a spring.

[0017] According to one embodiment of the present invention, an adjustable drilling device is provided that includes a shaft element disposed along a longitudinal axis and having a proximal end and a distal end, a cutting tooth operably and pivotally coupled to the shaft element, an adjustment element operably associated with the cutting tooth, and a spring configured to axially displace the adjustment element in a distal operating direction.

[0018] Preferably, the axial force of the spring allows radial extension of the cutting teeth relative to the shaft element, and more preferably the extent of the radial extension is defined by the extent of rotation of the adjustment element.

[0019] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will prevail. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. [Brief explanation of the drawings]

[0020] Some embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings, it is emphasized that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description with reference to the drawings will make apparent to those skilled in the art how embodiments of the present invention may be practiced. [Figure 1A] 1 is a flowchart of a drilling and reaming process according to some embodiments of the present invention. [Figure 1B] 10A-10C are state diagrams illustrating the states of a bone tunnel drill during drilling, reaming, and retraction states, according to some embodiments of the present invention. [Figure 1C] 1 is a schematic diagram of a bone removal device, according to some embodiments of the present invention. [Figure 1D] 1 is a schematic diagram of a bone removal device, according to some embodiments of the present invention. [Figure 1E] 1 is a schematic diagram of a bone removal device, according to some embodiments of the present invention. [Figure 1F] 1 is a schematic illustration of a bone drill, e.g., a cutting tooth, according to some exemplary embodiments of the present invention. [Figure 1G] 1 is a schematic illustration of a bone drill, eg, a cutting tooth, according to some exemplary embodiments of the present invention. [Figure 1H] 1A-1C are schematic diagrams of shafts with distal notched openings, according to some embodiments of the present invention. [Figure 1I] 1H is a schematic diagram of a bone punch within the distal notched opening of the shaft shown in FIG. 1H, according to some embodiments of the present invention. [Figure 1J] 1H is a schematic diagram of a bone punch within the distal notched opening of the shaft shown in FIG. 1H, according to some embodiments of the present invention. [Figure 1K] 10A-10C illustrate transitions between positions of a given bone punch relative to the shaft of a bone removal device, according to some embodiments of the present invention. [Figure 1L] 1 is a simplified pictorial illustration of an assembled view of a drilling device constructed and operative in accordance with certain embodiments of the present invention; [Figure 1M] 1 is a simplified pictorial illustration of an exploded view of a drilling device constructed and operative in accordance with certain embodiments of the present invention; [Figure 2A] 1C is a simplified pictorial diagram of a cutting tooth forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 2B] 1B is a plan view of a cutting tooth forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 2C] 1B is a plan view of a cutting tooth forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 3A] 1C is a simplified pictorial diagram of a crank forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 3B] 1B is a plan view of a crank forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 3C] 1B is a plan view of a crank forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 4A] 1C is a simplified pictorial diagram of a pusher element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 4B]1B is a plan view of a pusher element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 4C] 1B is a plan view of a pusher element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 5A] 1C is a simplified pictorial diagram of a shaft element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 5B] 1B is a plan view of a shaft element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 5C] 1B is a plan view of a shaft element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 5D] 1B is a plan view of a shaft element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 6A] 1C is a simplified pictorial diagram of a cover element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 6B] 1B is a plan view of a cover element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 6C] 6B through a cross-sectional view of a cover element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. [Figure 7A] 1C is a simplified pictorial diagram of a guide element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 7B] 1B is a plan view of a guide element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 7C] 7B through a cross-sectional view of a guide element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. [Figure 8A]1C is a simplified pictorial diagram of an adjustment element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 8B] 1B is a plan view of an adjustment element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 8C] 1B is a plan view of an adjustment element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 8D] 1B is a plan view of an adjustment element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 8E] 8C of an adjustment element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. [Figure 9A] 1C is a simplified pictorial diagram of a stopper element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 9B] 1B is a plan view of a stopper element forming part of the perforation device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 10A] 1C is a simplified pictorial diagram of a rotating element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 10B] 1B is a plan view of a rotating element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. FIG. [Figure 10C] 10B through line CC of FIG. 10B of a rotating element forming part of the drilling device of FIGS. 1L and 1M, according to some embodiments of the present invention. [Figure 11A] 1L and 1M, without showing the adjustment elements of FIGS. 8A-8E, according to some embodiments of the present invention. FIG. [Figure 11B] 1L and 1M, without showing the adjustment elements of FIGS. 8A-8E, according to some embodiments of the present invention. FIG. [Figure 11C] 1B is a cross-sectional view of a subassembly of the drilling device of FIGS. 1L and 1M along line CC in FIG. 11B, without showing the adjustment element of FIGS. 8A-8E, according to some embodiments of the present invention. [Figure 12A] 1L and 1M shown in a closed operational orientation prior to insertion into a patient's bone, according to some embodiments of the present invention. [Figure 12B] 1B is a cross-sectional view along line BB of the drilling device of FIGS. 1L and 1M shown in a closed operational orientation prior to insertion into a patient's bone, according to some embodiments of the present invention. [Figure 13A] 1B is a simplified plan view of the drilling device of FIGS. 1L and 1M shown in a closed operating orientation after forward drilling into a patient's bone, according to some embodiments of the present invention. FIG. [Figure 13B] 13A along line BB of the drilling device of FIGS. 1L and 1M shown in a closed operating orientation after forward drilling into a patient's bone, according to some embodiments of the present invention. [Figure 14A] 1A is a simplified plan view of the drilling device of FIGS. 1L and 1M shown in a first partially open operating orientation inserted into a patient's bone, according to some embodiments of the present invention. [Figure 14B] 14A along line BB of FIG. 14A of the drilling device of FIGS. 1L and 1M shown in a first partially open operating orientation inserted into a patient's bone, according to some embodiments of the present invention. [Figure 15A] 1L and 1M shown in a second, partially open operating orientation inserted into a patient's bone, according to some embodiments of the present invention. [Figure 15B] 15A along line BB of FIG. 15A of the drilling device of FIGS. 1L and 1M shown in a second, partially open operating orientation inserted into a patient's bone, according to some embodiments of the present invention. [Figure 16A]1B is a simplified plan view of the drilling device of FIGS. 1L and 1M shown in a fully open operational orientation inserted into a patient's bone, according to some embodiments of the present invention. FIG. [Figure 16B] 16A along line BB of FIG. 16A showing the drilling device of FIGS. 1L and 1M inserted into a patient's bone in a fully open operational orientation, according to some embodiments of the present invention. [Figure 17A] 1A is a simplified plan view of the drilling device of FIGS. 1L and 1M shown in a closed operational orientation prior to removal from a patient's bone, according to some embodiments of the present invention. FIG. [Figure 17B] 17A along line BB of FIG. 17A shows the drilling device of FIGS. 1L and 1M shown in a closed operational orientation prior to removal from a patient's bone, according to some embodiments of the present invention. [Figure 18A] 1L and 1M shown in a closed operating orientation after removal from a patient's bone, according to some embodiments of the present invention. [Figure 18B] 18A along line BB of FIG. 18A of the drilling device of FIGS. 1L and 1M shown in a closed operational orientation after removal from a patient's bone, according to some embodiments of the present invention. [Figure 19A] 1 is a simplified pictorial illustration of an assembled view of a drilling device constructed and operative in accordance with certain embodiments of the present invention; [Figure 19B] 1 is a simplified pictorial illustration of an exploded view of a drilling device constructed and operative in accordance with certain embodiments of the present invention; [Figure 19C] 1 is a simplified pictorial illustration of an exploded view of a perforation device having one or more plungers constructed and operative in accordance with certain embodiments of the present invention; [Figure 19D] 1 is a simplified pictorial diagram of an exploded view of a drilling device having a pin with an interference lock for securing an adjustment element, according to some embodiments of the present invention; [Figure 19E] 1 is a simplified pictorial diagram of a pin having an interference lock coupled to a retainer of a drilling device, according to some embodiments of the present invention. [Figure 19F] 1 is a simplified pictorial diagram of a pin having an interference lock coupled to a retainer of a drilling device, according to some embodiments of the present invention. [Figure 19G] 1 is a simplified pictorial diagram of a drilling device having an interchangeable shaft, according to some exemplary embodiments of the present invention; [Figure 19H] 1 is a simplified pictorial diagram of a drilling device having an interchangeable shaft, according to some exemplary embodiments of the present invention; [Figure 20A] 19C is a simplified pictorial diagram of a cam connector forming part of the punching device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 20B] 19C is a plan view of a cam connector forming part of the punching device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 20C] 19C is a plan view of a cam connector forming part of the punching device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 21A] 19C is a simplified pictorial diagram of a retainer forming part of the drilling device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 21B] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 21C] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 22A] 19C is a simplified pictorial diagram of a cam element forming part of the drilling device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 22B] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 22C] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 22D]19D is a simplified pictorial diagram of an adjuster, e.g., adjustment element, configured to interact with one or more adjustment retainers, e.g., plungers, forming part of the drilling device of FIG. 19C, according to some embodiments of the present invention. [Figure 22E] 19D is a plan view of an adjuster, eg, an adjustment element, configured to interact with one or more adjustment retainers, eg, plungers, forming part of the drilling device of FIG. 19C, according to some embodiments of the present invention. [Figure 22F] 19D is a plan view of an adjuster, eg, an adjustment element, configured to interact with one or more adjustment retainers, eg, plungers, forming part of the drilling device of FIG. 19C, according to some embodiments of the present invention. [Figure 23A] 19C is a simplified pictorial diagram of a bit connector forming part of the drilling device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 23B] 19C is a plan view of a bit connector forming part of the drilling device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 23C] 19C is a plan view of a bit connector forming part of the drilling device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 24A] 19C is a simplified pictorial diagram of a cover element forming part of the perforation device of FIGS. 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 24B] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 24C] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 24D] 24B through a cross-sectional view of a cover element, taken along line EE of FIG. 24B, that forms part of the perforation device of FIGS. 19A and 19B, according to some embodiments of the present invention. [Figure 24E]24B through a cross-sectional view of a cover element, taken along line EE of FIG. 24B, that forms part of the perforation device of FIGS. 19A and 19B, according to some embodiments of the present invention. [Figure 24F] 19D is a simplified pictorial diagram including a top view of a cover element forming part of the perforation device of FIG. 19C, according to some embodiments of the present invention. [Figure 24G] 19D is a simplified pictorial diagram including a top view of a cover element forming part of the perforation device of FIG. 19C, according to some embodiments of the present invention. [Figure 24H] 19D is a simplified pictorial diagram including a top view of a cover element forming part of the perforation device of FIG. 19C, according to some embodiments of the present invention. [Figure 24I] 19D is a simplified pictorial diagram including a cross-sectional view of a cover element forming part of the perforation device of FIG. 19C, according to some embodiments of the present invention. [Figure 24J] 19D is a simplified pictorial diagram of a spring plunger and the interaction between the spring plunger and the adjuster and socket of the cover forming part of the punching device of FIG. 19C, according to some embodiments of the present invention. [Figure 24K] 19D is a simplified pictorial diagram of a spring plunger and the interaction between the spring plunger and the adjuster and socket of the cover forming part of the punching device of FIG. 19C, according to some embodiments of the present invention. [Figure 24L-M] 19D is a simplified pictorial diagram of a spring plunger and the interaction between the spring plunger and the adjuster and socket of the cover forming part of the punching device of FIG. 19C, according to some embodiments of the present invention. [Figure 25A] FIG. 19C is a simplified pictorial diagram of a leaf spring forming part of the drilling device of FIGS. 19A and 19B, according to some embodiments of the present invention. [Figure 25B] 19A and 19B, according to some embodiments of the present invention. FIG. [Figure 25C]19A and 19B, according to some embodiments of the present invention. FIG. [Figure 26A-C] 26A and 26B are two different plan views of the drilling device of FIGS. 19A and 19B shown in a closed operating orientation before insertion into a patient's bone, according to some embodiments of the present invention. [Figure 27A-C] 27B along line BB in FIG. 27B, showing two different plan views of the drilling device of FIGS. 19A and 19B in a closed operating orientation after forward drilling into a patient's bone, according to some embodiments of the present invention. [Figure 28A-C] 28B are two different plan views of the drilling device of FIGS. 19A and 19B shown in a first partially open operating orientation inserted into a patient's bone, according to some embodiments of the present invention, and a cross-sectional view along line BB of FIG. [Figure 29A-C] 29A and 29B are two different plan views of the drilling device of FIGS. 19A and 19B shown in a second, partially open operating orientation inserted into a patient's bone, according to some embodiments of the present invention, and a cross-sectional view along line BB of FIG. [Figure 30A-C] 30A and 30B are two different plan views of the drilling device of FIGS. 19A and 19B shown in a fully open operating orientation inserted into a patient's bone, according to some embodiments of the present invention. [Figure 31A-C] 31B along line BB in FIG. 31B, showing two different plan views of the drilling device of FIGS. 19A and 19B in a closed operating orientation prior to removal from the patient's bone, according to some embodiments of the present invention. [Figure 32A-C] 32A and 32B are two different plan views of the drilling device of FIGS. 19A and 19B shown in a closed operating orientation after removal from a patient's bone, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0021] FIELD OF THE INVENTION The present invention relates generally to bone removal tools, such as tools that vary the effective diameter, and particularly to drilling.

[0022] One aspect of some embodiments relates to a bone removal device, e.g., a drilling device, having a bone drill for both drilling and selective reaming, e.g., retro-reaming. In some embodiments, the bone drill comprises at least one drilling tip and at least one separate reamer with one or more reaming edges. In some embodiments, the bone drill moves between a drilling state and one or more reaming states by changing the orientation of the bone drill relative to the drilling device. In some embodiments, in each state, one or both of the at least one drilling tip and the at least one reaming edge are positioned in contact with tissue, e.g., bone tissue, cartilage tissue, muscle tissue, or any other soft tissue of the body.

[0023] According to some embodiments, in the drilling state, the bone drill tool is axially aligned with the longitudinal axis of the drilling device. Optionally, in the drilling state, only at least one drilling tip is positioned in contact with tissue. In some embodiments, in one or more hole enlarging states, e.g., the reaming state, the bone drill tool is angled, e.g., at least a portion of the bone drill tool extends transversely to the longitudinal axis of the drilling device. In some embodiments, in one or more hole enlarging states, at least one reaming edge extends transversely and is positioned in contact with tissue. Optionally, in one or more hole enlarging states, only at least one reaming edge is positioned in contact with tissue. In some embodiments, when the bone drill tool is angled, the bone drill tool or the longitudinal axis of the bone drill tool is positioned at an angle relative to the body, e.g., the shaft of the bone removal device, or relative to the longitudinal axis of the shaft.

[0024] According to some embodiments, the bone drill tool moves between two or more lateral extension states, e.g., radial extension states, e.g., 2, 3, 4, 5, 6, or any greater number of lateral extension states. In some embodiments, the lateral extension states are predetermined extension states. In some embodiments, each of the extension states is used to generate potential bone openings having different widths, e.g., diameters of the openings in the bone tissue. In some embodiments, when the bone drill tool is axially aligned with the longitudinal axis of the device, the width of the bone opening is similar to the maximum width of the forward-facing end of the bone drill tool. Alternatively, when the bone drill tool is axially aligned with the longitudinal axis of the device, the width of the bone opening is greater than the maximum width of the forward-facing end of the bone drill tool by up to 10%, e.g., by up to 10%, up to 5%, up to 2%, up to 1%, or any intermediate, smaller, or greater value.

[0025] According to some embodiments, extension of the bone drill laterally relative to the longitudinal axis of the drilling device, e.g., while the drill is rotating, increases the width of the bone opening by up to five times, e.g., up to three times, or up to two times, compared to the maximum width of the forward-facing end of the bone drill. In some embodiments, the bone drill is angled at an angle ranging from 0 to 180°, e.g., 0 to 45°, 15 to 90°, 45 to 135°, or any intermediate, lesser, or greater angle range. In some embodiments, the bone drill extends laterally up to 10 mm, e.g., up to 8 mm, up to 6 mm, or any intermediate, lesser, or greater distance from the drilling device.

[0026] A potential advantage of having a bone removal device with angled bone drills is that this may allow for a one-size-fits-all instrument useful for creating openings in bones of different sizes using a single device.

[0027] One aspect of some embodiments relates to a bone drill for both anterior drilling and lateral bone cutting. According to some embodiments, the bone drill comprises one or more drilling sections, also referred to herein as "drilling tips" or "drilling ends," e.g., one, two, three, or any greater number of drilling sections. Additionally, the bone drill comprises a reaming portion having one or more reaming edges, e.g., one, two, three, or any greater number of reaming edges, spaced apart from the drilling section. In some embodiments, the drilling section is located at the distal end of the bone drill, e.g., the drilling section that optionally faces anteriorly when the bone drill is axially aligned with the longitudinal axis of the drilling device. In some embodiments, the reaming edges are located at the proximal end of the bone drill.

[0028] According to some embodiments, the one or more reaming edges are shaped and sized to remove bone fragments, for example, when the bone drill is in one or more open states. In some embodiments, the one or more reaming edges are shaped and sized to remove bone fragments when the bone drill is in an open state and retracted into bone tissue. In some embodiments, the one or more drilling sections are configured to remove bone fragments, for example, when the bone drill is advanced axially into bone tissue. In some embodiments, the one or more drilling sections are integral elements of the bone drill and, optionally, are stationary relative to the bone drill.

[0029] According to some embodiments, the one or more reaming edges are an integral part of the bone drill. In some embodiments, the one or more reaming edges are stationary relative to the bone drill. In some embodiments, the one or more reaming edges are lateral reaming edges, optionally located on the circumference of the bone drill, e.g., up to 5 mm from the proximal end of the bone drill, e.g., 4 mm, 3 mm, 2 mm, 1 mm, or any intermediate, smaller, or larger distance. In some embodiments, the reaming edges are shaped and sized to cut bone fragments when the bone drill is rotated and tilted. In some embodiments, when the bone drill is tilted, at least some of the one or more reaming edges are placed in contact with bone tissue. Optionally, when the bone drill is tilted, e.g., when the bone drill is retracted into bone tissue, at least some of the reaming edges extend laterally relative to the bone tissue.

[0030] An aspect of some embodiments relates to tilting the bone drill tool of the bone removal device to a closed position during or after retroreaming. In some embodiments, the bone drill tool is easily tilted to a closed position within the opening in the body of the bone removal device by removing bone debris from the body opening. Alternatively or additionally, the bone drill tool is easily tilted into the opening in the shaft by pressing one or more curved drilling edges at the proximal end of the bone drill tool against the bone tissue surface contacting the curved drilling edges as the device is retracted from the bone tissue.

[0031] According to some embodiments, the opening is located near the bone cut site. In some embodiments, the opening is configured to move between a closed position and an open position. In some embodiments, the opening is closed during axial drilling. In some embodiments, during reaming (also referred to herein as "widening"), removed bone fragments accumulate on one side of the bone removal device and the opening is opened, e.g., to allow at least some of the removed bone fragments to pass through the opening to the opposite side of the bone removal device.

[0032] According to some embodiments, a bone drill is at least partially disposed within the opening. Optionally, the bone drill is pivotally connected to the bone cutting device at least partially within the opening. In some embodiments, during drilling, e.g., axial drilling, the opening is closed, e.g., at least 95%, at least 97%, or at least 99% of the opening is optionally closed by the bone drill. In some embodiments, during reaming, the opening is at least partially opened, e.g., at least 10%, at least 30%, at least 50%, or any intermediate, smaller, or larger percentage value of the opening. In some embodiments, the opening is opened by movement, e.g., tilting, of the bone drill relative to the device. In some embodiments, the bone drill is tilted at least 5° relative to the device, e.g., at least 10°, at least 25°, at least 40°, or any intermediate, smaller, or larger tilt angle relative to the device.

[0033] According to some embodiments, the bone tunnel tool comprises one or more curved reaming edges located at a proximal end of the bone tunnel tool, hi some embodiments, the one or more curved reaming edges have an angle of less than 90°, e.g., less than 45°, less than 30°, or any intermediate, lesser, or greater angle, relative to the surface of the bone tissue that contacts the bone tunnel tool during retraction of the bone tunnel tool from the bone.

[0034] An aspect of some embodiments relates to applying a force to a drilling device to adjust the cutting width of the bone opening in a direction different from the direction of rotation of the drilling device. In some embodiments, the bone drill adjustment mechanism, e.g., the bone cutting teeth adjustment mechanism of the drilling device, rotates about an axis different from the drilling rotation axis of the device. In some embodiments, the cutting teeth adjustment mechanism rotates about an axis that is substantially perpendicular to the drilling rotation axis of the device. In some embodiments, the cutting teeth adjustment mechanism rotates about an axis located at an angle of 10 to 90 degrees, e.g., 10 to 45 degrees, 30 to 70 degrees, 40 to 90 degrees, or any intermediate, smaller, or larger angle range, relative to the drilling rotation axis of the device.

[0035] A potential advantage of rotating the bone cutting adjustment mechanism about an axis different from the axis of rotation of the drilling device may be to reduce the risk of the rotation of the drilling device affecting the bone cutting adjustment mechanism.

[0036] One aspect of some embodiments relates to alignment of a bone cutting adjustment mechanism of a drilling device, where the drilling device includes a cutting tooth inclination angle adjuster that is arranged in a discrete holding state, e.g., a discrete stop state, at a selected position relative to a selected inclination angle of a bone drill tool, e.g., a bone cutting tooth of the drilling device. As used herein, the term "discrete" is distinct. In some embodiments, an adjustment mechanism formed at least partially from a polymer is aligned with a bone cutting tooth made from a metal. In some embodiments, the bone cutting adjustment mechanism is fixedly coupled to the cutting tooth when the tooth is in the selected position and the adjustment mechanism is in the discrete holding state. In some embodiments, the bone cutting adjustment mechanism is aligned with the selected position of the cutting tooth during manufacture of the drilling device.

[0037] According to some embodiments, a pusher element coupled to the cutting tooth is fixedly connected to the bone cutting adjustment mechanism when the tooth is in a selected position and the adjustment mechanism is in a discrete holding state. In some embodiments, the bone cutting adjustment mechanism includes a rotational adjuster. In some embodiments, the rotational adjuster moves between a plurality of discrete holding states, e.g., discrete stop states. In some embodiments, the pusher element is fixedly connected to the rotational adjuster when the rotational adjuster is positioned in a selected discrete holding state and the cutting tooth is positioned at the selected position.

[0038] According to some embodiments, for example, during manufacture of the bone removal device, a movable cutting tooth positioned at a selected tilt angle relative to an axis of the bone removal device is aligned with a cutting tooth tilt angle adjuster positioned at a selected stop. In some embodiments, once the cutting tooth is aligned with the tilt angle adjuster, the aligned cutting tooth is operably coupled to the aligned tilt angle adjuster. Optionally, the aligned cutting tooth and the aligned tilt angle adjuster are mechanically coupled to a pusher element.

[0039] One aspect of some embodiments relates to holding a bone drill, e.g., an osteotomy tooth, by at least two spaced apart protrusions of the tooth-holding element, each of which is attached to a sidewall of the bone drill so that the bone drill is held from two sides, e.g., two opposing sides. In some embodiments, the portion of the spaced apart protrusions that contact the sidewall of the osteotomy tooth is curved or angled. In some embodiments, the tooth-holding element, e.g., a crank, is, for example, axially coupled, coupled to the tooth on a first end and to a movable rod, e.g., a pusher element, on a second end. In some embodiments, the crank is pivotally coupled to the movable rod by two spaced apart protrusions. Optionally, the two spaced apart protrusions connecting the movable rod to the crank are straight.

[0040] A potential advantage of retaining the movable tooth with two angled prongs may be to increase the resistance of the bone drill to torsional forces, for example, torsional forces applied to the bone drill during rotation of the bone drill while in contact with bone tissue.

[0041] According to some embodiments of the present invention, the drilling device drills a hole in bone with the forward-facing drilling tips when the bone-cutting teeth are in a closed position, e.g., axially aligned with the longitudinal axis of the device. In some embodiments, the width of the hole drilled in the bone is defined by the maximum width of the drilling tips or the maximum width of the distal ends of the cutting teeth. In some embodiments, the cutting teeth are used as a reamer to increase the width of the hole.

[0042] According to some embodiments, for example, during reaming, the cutting teeth are tilted between two or more predetermined retention positions, e.g., predetermined rest positions. In some embodiments, during reaming, e.g., during retrograde reaming, the teeth are tilted to position a lateral bone cutting edge, e.g., a proximal bone cutting edge, in contact with the bone. In some embodiments, each predetermined retention position defines a different lateral extension distance of the bone cutting edge. In some embodiments, rotation of the drilling device, e.g., rotation of the cutting teeth in the closed position, creates a bone opening having a width ranging from 2 to 4.5 mm, e.g., 2 to 3 mm, 2.5 to 4 mm, 3.5 to 4.5 mm, or any intermediate, smaller, or larger diameter. In some embodiments, rotation of the drilling device allows for the creation of a bone opening having a width ranging from 9 to 16 mm, e.g., 9 to 12 mm, 11 to 14 mm, 12 to 16 mm, or any intermediate, smaller, or larger diameter, for example, when the cutting edge is at its maximum lateral extension distance.

[0043] According to some embodiments, each predetermined holding state of the bone cutting teeth is associated with a different selected width of the opening, e.g., the bone opening. In some embodiments, a movable adjuster of the drilling device, which controls the angle of inclination of the teeth, moves between the discrete, predetermined holding states. In some embodiments, moving the adjuster between two successive holding states changes the width of the bone opening by 0.5-3 mm, e.g., 0.5-1.5 mm, 1-2 mm, 1.5-3 mm, or any intermediate, smaller, or larger value.

[0044] An aspect of some embodiments relates to adjusting the size of the drilling and reaming portions of a drilling device by exchanging the bone drill and / or the bone drill adjustment mechanism. In some embodiments, the drilling and / or reaming portions of the drilling device are removably coupled to the adjustment mechanism of the drilling device. In some embodiments, the bone drill is removably coupled to the body or adjustment mechanism of the drilling device, e.g., to allow for easy exchange of the bone drill. Additionally or alternatively, the body of the drilling device, e.g., a shaft optionally comprising the bone drill, is removably coupled to the adjustment mechanism of the drilling device, e.g., to allow for easy exchange of the body with the bone drill.

[0045] A potential advantage of having interchangeable bone tunneling tools or shafts may be to allow for easy adjustment of the tunneling device to different pediatric and / or veterinary applications that require having a shorter and / or wider body or a different size bone tunneling tool.

[0046] Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0047] Exemplary Process for Drilling and Reaming a Bone Opening According to some exemplary embodiments, an opening is formed in a bone, for example, a femur / tibia, scapula, clavicle, humerus, or any other type of bone for that matter. In some embodiments, the opening is formed in two stages: a drilling stage, in which a drill hole is penetrated into the bone, for example, to form an initial hole in the bone, and a reaming stage, in which the hole is widened to a desired width. Reference is now made to FIG. 1A, which illustrates a process for forming an opening in a bone by drilling and reaming using a bone drill, according to some exemplary embodiments of the present invention.

[0048] According to some exemplary embodiments, at block 101, desired bone opening dimensions are determined. In some embodiments, the desired bone opening characteristics are determined based on the clinical application, the anatomical location of the bone opening, its relative distance to other tissues, e.g., blood and nerve tissue, and the patient's clinical condition. In some embodiments, the bone opening characteristics include a maximum depth of the bone opening, a minimum and / or maximum width of the bone opening, and / or a shape of the bone opening, and / or are based on the size of the ligament or meniscus root.

[0049] According to some exemplary embodiments, a bone drill, such as a bone drill of a bone removal device, is used to drill an initial hole in the bone at block 103. In some embodiments, the bone drill drill drills into the bone to a desired depth. In some embodiments, a drilling tip, such as a distal, forward-facing drilling tip of the bone drill, is used for drilling at block 103.

[0050] According to some exemplary embodiments, at block 105, the lateral extension of the bone drill is adjusted. In some embodiments, the lateral extension of the bone drill is adjusted by modifying the inclination angle of the bone drill relative to the drilling device, e.g., relative to the longitudinal axis of the drilling device. In some embodiments, a portion of the bone drill extends laterally, e.g., radially, relative to the periphery of the drilling device, e.g., relative to the shaft of the drilling device. In some embodiments, the lateral extension of the bone drill determines the reaming width, e.g., the reaming diameter of the bone opening. In some embodiments, the lateral extension of the bone drill places one or more reaming edges on, optionally near, the periphery of the bone drill or at the proximal end of the bone drill in contact with bone tissue.

[0051] According to some exemplary embodiments, at block 109, a bone drill tool is used, e.g., to widen (ream) the bone opening. In some embodiments, during reaming, the bone drill tool is rotated while at least a portion of the bone drill tool extends laterally to contact bone tissue. Optionally, at block 109, during reaming, the bone drill tool is retracted. In some embodiments, during reaming, the lateral extension of the bone drill tool is adjusted, e.g., to modify the reaming width, e.g., to increase or decrease the reaming width.

[0052] According to some exemplary embodiments, the bone tunnel drill is retracted at block 111. In some embodiments, the bone tunnel drill is retracted during the reaming process, for example, as described at block 111. Alternatively, the bone tunnel drill is retracted when the reaming process is completed, for example, when forming a wide interior void in bone tissue with a narrow opening. In some embodiments, once the bone tunnel drill is retracted, the reaming is repeated at block 109.

[0053] Example cutting conditions during drilling and reaming According to some exemplary embodiments, the bone drill, e.g., cutting teeth, of the bone removal device is mechanically coupled to a body, e.g., an elongated shaft, having a distal end, a proximal end, and a longitudinal axis of the bone removal device. In some embodiments, the bone drill is movable relative to the body. In some embodiments, the bone drill is configured to move between a closed state in which the bone drill is aligned with the longitudinal axis of the body and one or more laterally extending states, e.g., one or more radially extending states, in which the bone drill is angled relative to the longitudinal axis of the body. In some embodiments, in the closed state, the bone drill is positioned within a perimeter defined by the outer surface of the body. In some embodiments, in the one or more laterally extending states, the bone drill extends outward from the perimeter. Referring now to FIG. 1B, a change in orientation of the bone drill relative to the body of the bone removal device during a bone drilling process is shown, according to some exemplary embodiments of the device.

[0054] According to some exemplary embodiments, the cutting teeth are in a closed position while drilling through bone tissue, e.g., during the drilling state in block 113. In some embodiments, in the closed position, the cutting teeth are aligned, e.g., aligned with the longitudinal axis of the device body. In some embodiments, in the closed position, the cutting teeth are positioned within a perimeter defined by the outer surface of the device body. Alternatively, in the closed position, the cutting teeth are axially aligned with the device body and extend from the perimeter defined by the device body, e.g., if the width of the distal end of the cutting teeth, including one or more drilling heads, is greater than the width of the device body. In some embodiments, during the drilling state, the cutting teeth rotate, and the width of the hole is determined by the maximum width of the distal end of the cutting teeth.

[0055] According to some exemplary embodiments, during the reaming state in block 115, the cutting teeth are in one or more open positions, e.g., two, three, four, or five open positions. Optionally, the one or more open positions are predetermined open positions. In some embodiments, when the cutting teeth are in the open positions, the cutting teeth are inclined relative to the body of the device, e.g., relative to the longitudinal axis of the body of the device. In some embodiments, each open position corresponds to a selected inclination angle of the cutting teeth. In some embodiments, when the cutting teeth are in one or more open positions, at least a portion of the cutting teeth extends laterally from the body of the device. In some embodiments, the cutting teeth are retracted during reaming.

[0056] According to some exemplary embodiments, during the retracted state in block 117, the cutting teeth are in a closed position, for example, when forming a void in bone with a narrow opening or entry point. Alternatively, during the retracted state, the cutting teeth are in one or more open positions, for example, when forming a void in bone with a wide opening or entry point. In some embodiments, when the cutting teeth are in the closed position, the cutting teeth are axially aligned with the body of the device, for example, as described as block 113. In some embodiments, when the cutting teeth are in one or more open positions, the cutting teeth are angled relative to the body of the device or the longitudinal axis of the body.

[0057] Exemplary General Bone Removal Device According to some exemplary embodiments, a bone removal device, e.g., a drilling device, is used both to drill an initial hole in the bone and to ream the hole, e.g., to form an opening in the bone. In some embodiments, the device is moved between a drilling state and an expanding state, e.g., a reaming state, by changing the orientation of the device's bone drill tool, e.g., the bevel angle of the bone drill tool relative to the device body. In some embodiments, the bevel angle of the drilling end or drill tip of the drilling portion, e.g., the bone drill tool, is changed between a drilling state, where the drilling end is axially aligned with the device body, and a reaming state, where the drill tip is beveled at an angle relative to the device body. Reference is now made to FIGS. 1C and 1D, which depict a bone removal device with a movable bone drill tool, according to some exemplary embodiments of the present invention.

[0058] According to some exemplary embodiments, a bone removal device, e.g., device 119, comprises a body, e.g., an elongated shaft 121 having a longitudinal axis 123, a distal end 125, and a proximal end 127. As used herein, distal refers to a location closer to the bone tissue, and proximal refers to a location further from the bone tissue. In some embodiments, the elongated shaft 121 is hollow. Optionally, the elongated shaft is shaped as a cylinder. In some embodiments, the maximum width of the distal end 125 of the shaft 121 is in the range of 1.5-4.5 mm, e.g., 1.5-2.5 mm, 2-4 mm, 3-3.5 mm, or any intermediate, smaller, or larger value.

[0059] According to some exemplary embodiments, device 119 includes a bone drill, e.g., cutting teeth 131, mechanically coupled to distal end 125 of body 121. In some embodiments, bone drill includes one or more distal drilling portions 133, e.g., drilling tips. In some embodiments, one or more distal drilling portions include Nirosta, titanium, or any other hardened biocompatible material. In some embodiments, one or more drilling portions are forward-facing portions to enable drilling into bone tissue, e.g., when teeth 131 are axially aligned with longitudinal axis 123 of shaft 121. Optionally, one or more drilling portions are also used to widen the bone opening, e.g., during a reaming process. Additionally, teeth 131 include one or more proximal bone-cutting edges, e.g., cutting edges 135 and 137. In some embodiments, the bone-cutting edge is located on one of the peripheries of cutting teeth 131. In some embodiments, one or more proximal bone-cutting edges are angled edges. Optionally, bone cutting edges are located at opposing positions on the periphery of cutting teeth 131 .

[0060] According to some exemplary embodiments, the length of shaft 121, e.g., the elongate shaft between its distal and proximal ends, is 5-40 cm, e.g., 5-20 cm, 15-30 cm, 25-40 cm, or any intermediate, smaller, or larger range value. In some embodiments, the maximum width of shaft 121 is in the range of 0.5-8 mm, e.g., 0.5-3 mm, 1-5 mm, 3-8 mm, or any intermediate, smaller, or larger range value.

[0061] According to some exemplary embodiments, the maximum width 143 of the cutting teeth 131 is equal to or greater than the maximum width of the distal end 125 of the shaft 121. In some embodiments, the maximum width 143 is in the range of 1.5 to 4.5 mm, e.g., 1.5 to 2.5 mm, 2 to 4 mm, 3 to 3.5 mm, or any intermediate, smaller, or larger value. In some embodiments, the length 145 of the cutting teeth 131 is in the range of 1 to 12 mm, e.g., 1 to 4 mm, 2 to 8 mm, 5 to 12 mm, or any intermediate, smaller, or larger value. In some embodiments, the length 145 is in the range of 6 to 9.5 mm, e.g., 7 mm, 8 mm, 9 mm, or any intermediate, smaller, or larger value. In some embodiments, the cutting teeth 131 are formed from nilostachys, titanium, or zirconium. Optionally, both drilling tip 133 and one or more bone cutting edges, eg, cutting edges 135 and 137 , are integral parts of incisor 131 .

[0062] According to some exemplary embodiments, bone removal device, e.g., device 119, includes a transversely extending adjuster of the bone drill, e.g., adjuster 129, mechanically coupled to shaft 121 and operatively coupled to cutting teeth 131. In some embodiments, adjuster 129 is configured to adjust the transverse extension and / or inclination angle of the bone drill, e.g., cutting teeth 131, optionally by rotating the adjuster through selected rotational angles. In some embodiments, each rotational angle corresponds to a selected bone drill extension distance or a selected bone drill inclination angle of cutting teeth 131. Optionally, adjuster 129 is rotated to a predetermined rotational angle corresponding to a predetermined bone drill extension distance or a predetermined bone drill inclination angle.

[0063] According to some exemplary embodiments, the axis of rotation of the adjuster 129 is parallel to the longitudinal axis 123 of the device body. Optionally, the axis of rotation of the adjuster is the longitudinal axis 123 of the device body. Alternatively, the axis of rotation of the adjuster 129 intersects with or is perpendicular to the longitudinal axis of the device body 123. In some embodiments, the device 119 rotates about the longitudinal axis 123 of the device body during drilling and / or reaming. A potential advantage of rotating the adjuster 129 about an axis that intersects with or is perpendicular to the axis of rotation of the device 119 is that it can help avoid rotation of the adjuster when the device rotates during drilling and / or reaming.

[0064] According to some exemplary embodiments, the adjuster 129 is operatively coupled to the cutting tooth 131 by a movable coupler 139, e.g., a pusher element. In some embodiments, a pusher element is used as a puller element. In some implementations, the movable coupler 139 is coaxially coupled to the elongated shaft 121. Optionally, the movable coupler 139 is positioned within the elongated shaft, e.g., coaxially coupled within the elongated shaft 121. In some embodiments, the movable coupler 139 is configured to translate rotational movement of the adjuster 129 into movement of the cutting tooth 131, e.g., into lateral extension and / or tilting of the cutting tooth 131. In some embodiments, the movable coupler 139 moves forward toward the cutting tooth 131 or retracts toward the adjuster 129, e.g., in response to rotation of the adjuster 129. Alternatively or additionally, the movable coupler 139 rotates clockwise or counterclockwise in response to rotation of the adjuster 129.

[0065] According to some exemplary embodiments, adjuster 129 includes one or more markings, e.g., marking 141, configured to provide a human-detectable indication, e.g., a visual indication regarding the rotation state, range of rotation, and / or angle of rotation of the adjuster. Alternatively or additionally, marking 141 is configured to deliver a human-detectable indication regarding the open state, lateral extension, e.g., radial extension, and / or inclination angle of cutting teeth 131. Optionally, the human-detectable indication is provided by alignment between marking 141 and additional markings on device 119, e.g., on the body of the device.

[0066] According to some exemplary embodiments, as shown, for example, in FIG. 1D , rotation of adjuster 129 changes the orientation of cutting teeth 131 from axial alignment along longitudinal axis 123, as shown, for example, in FIG. 1C , to an inclined orientation relative to longitudinal axis 123 or body of the device, e.g., to an open position for the cutting teeth. In some embodiments, in the inclined orientation, distal perforating portion 133 rotates in a first direction while cutting edges, e.g., cutting edges 135 and 137, rotate in opposite directions. In some embodiments, in the open position, one or both of distal perforating portion and cutting edges 135 and 137 extend at least partially laterally, optionally in a different direction. In some embodiments, further rotation of adjuster in the same or opposite rotational direction increases the extension distance of the cutting edges from shaft 121.

[0067] 1E , cutting teeth 131 extend laterally up to a maximum extension distance of one or more cutting edges 135 and 137 from shaft 121 of up to 10 mm, e.g., up to 7 mm, up to 5 mm, or any intermediate, smaller, or larger value. In some embodiments, the extension distance of one or more cutting edges is greater than the extension distance of distal perforated portion 133. Alternatively, the extension distances of cutting edges 135 and 137 and distal perforated portion 133 from shaft 121 are similar, e.g., with a deviation of less than 5%, e.g., less than 3%, less than 2%, or any intermediate, smaller, or larger deviation percentage. In some embodiments, cutting teeth 131 are substantially perpendicular to shaft 121 and / or longitudinal axis 123 when one or more cutting edges, e.g., cutting edges 135 and 137, are at their maximum extension distance.

[0068] According to some exemplary embodiments, as shown, for example, in FIG. 1F , a bone drill, e.g., a cutting tooth 161 having a distal end and a proximal end, includes one or more distal drilling portions, e.g., drilling tips 163, at the drilling end, and at least one reaming edge, e.g., reaming edge 165, at the proximal end. Optionally, the cutting tooth includes one or more additional reaming edges 167. In some embodiments, the reaming edges 165 and 167 are disposed on opposite sides of the cutting tooth 165. Optionally, the reaming edges 165 and 167 converge to a single point. In some embodiments, as shown, for example, in FIG. 1F , the cutting tooth 161 includes an additional reaming edge at the distal end of the cutting tooth 161, e.g., a reaming edge 169 connecting the two reaming edges 165 and 167. Alternatively, the reaming edge 169 is connected to either the reaming edge 165 or the reaming edge 167.

[0069] 1G , a bone drill, e.g., cutting tooth 171, having a distal end and a proximal end, includes one or more distal drilling portions, e.g., drilling tip 173, at the drilling end, and at least one reaming edge, e.g., reaming edge 175, at the proximal end. In some embodiments, the cutting tooth, e.g., cutting tooth 171, includes an additional reaming edge 177 at the proximal end of cutting tooth 171. In some embodiments, reaming edges 175 and 177 optionally meet at a single point that is a contact point between the two reaming edges, e.g., contact point 179.

[0070] According to some exemplary embodiments, reaming edges located at or near the proximal ends of the cutting teeth form the reaming portions of the cutting teeth, and in some embodiments, when the cutting teeth are angled relative to the shaft or body of the device, different reaming edges are placed in contact with the bone as the device is retracted.

[0071] Exemplary Bone Fragment Removal Opening According to some exemplary embodiments, when the cutting teeth are in the open position, at least a portion of the cutting teeth extend laterally from the body of the bone removal device and are positioned in contact with bone tissue. In some embodiments, during the reaming stage, the cutting teeth, which are pivotally connected to the body, rotate and accumulate the cut bone fragments. In some embodiments, an opening is formed in the body of the bone removal device for removing the bone fragments from the cut site. Reference is now made to FIGS. 1H-1J, which depict a side-to-side cross window, according to some exemplary embodiments of the present invention.

[0072] According to some exemplary embodiments, as shown, for example, in FIG. 1H, the body of the bone removal device, e.g., elongated shaft 147, comprises a distal end 149 and a proximal end 151. In some embodiments, shaft 147 comprises a side-to-side traversing opening, e.g., opening 153. In some embodiments, opening 153 is formed by two or more opposing notches in distal end 149 of shaft 147.

[0073] According to some exemplary embodiments, as shown, for example, in FIG. 1I , a bone drill, e.g., cutting tooth 155, is pivotally coupled to the distal end 149 of shaft 147 at least partially within opening 153. In some embodiments, when the cutting tooth is in a closed position, e.g., during drilling, the opening, e.g., the volume of the opening, is at least 90% closed, e.g., at least 90%, at least 95%, at least 98%, or any intermediate, lesser, or greater percentage of the opening is closed.

[0074] According to some exemplary embodiments, in the open position, as shown, for example, in FIG. 1J , the cutting teeth 155 are angled, with at least a portion of the cutting teeth extending laterally from the shaft 147. In some embodiments, the angle of the cutting teeth 155 opens the opening 153 by at least 20%, e.g., at least 25%, at least 40%, at least 50%, or any intermediate, smaller, or larger value. In some embodiments, when the opening 153 is open, bone fragments cut on one side of the shaft 147, e.g., during reaming, can traverse through the shaft to the other side of the shaft 147. Alternatively or additionally, if the shaft is hollow, bone fragments cut by the cutting teeth, e.g., during reaming, can pass through the opening and enter the lumen of the hollow shaft.

[0075] Exemplary Predetermined Aperture Width Selection According to some exemplary embodiments, during the drilling process, e.g., to form an initial hole, the hole width is based on the width of the drill hole or one or more drilled portions. In some embodiments, when enlarging, e.g., when reaming the initially formed hole to a desired opening width, a predetermined state of the adjuster extending laterally across the bone hole associated with the desired bone opening width is selected. In some embodiments, the adjuster rotates incrementally when moving between the predetermined states. Referring now to FIG. 1I, selection of an adjuster state corresponding to a predetermined bone opening width or bone drill extension distance is shown, according to some exemplary embodiments of the present invention.

[0076] According to some exemplary embodiments, the bone hole is closed during drilling, e.g., to form an initial hole. In some embodiments, during drilling, the bone punch is positioned within a perimeter defined by the outer surface of the shaft. In some embodiments, once the bone punch is closed, the adjuster is in a first state, e.g., state #0. In some embodiments, when the adjuster is in the first state, rotation of the bone punch forms a bone opening having a width in the range of 3-4 mm, e.g., 3 mm, 3.5 mm, 4 mm, or any intermediate, smaller, or larger value.

[0077] According to some exemplary embodiments, when the adjuster is moved to a second predetermined state, for example by rotating the adjuster to state #1, the bone punch opens to a predetermined extension distance associated with a predetermined width #2 of the bone opening. In some embodiments, when the adjuster is in the second state (state #1), rotation of the bone punch creates a bone opening having a width #2 that is in the range of 5-7 mm, e.g., 5 mm, 5.5 mm, 6 mm, or any intermediate, smaller, or larger value.

[0078] According to some exemplary embodiments, when the adjuster is moved to a third predetermined state, for example, by rotating the adjuster to state #2, the bone punch is opened to a predetermined extension distance. In some embodiments, when the adjuster is in the third state (state #2), rotation of the bone punch creates a bone opening having a width #3 in the range of 6-8 mm, e.g., 6 mm, 7 mm, 8 mm, or any intermediate, smaller, or larger value.

[0079] According to some exemplary embodiments, when the adjuster is moved to a fourth predetermined state, for example, by rotating the adjuster to state #3, the bone punch opens to a predetermined extension distance. In some embodiments, when the adjuster is in state #3, rotation of the bone punch creates a bone opening having a width #4 in the range of 7-9 mm, e.g., 7.5 mm, 8 mm, 8.5 mm, or any intermediate, smaller, or larger value.

[0080] According to some exemplary embodiments, when the adjuster is moved to a fifth predetermined state, for example, by rotating the adjuster to state #4, the bone punch opens to a predetermined extension distance. In some embodiments, when the adjuster is in state #4, rotation of the bone punch creates a bone opening having a width #5 in the range of 10-12 mm, e.g., 10 mm, 11 mm, 12 mm, or any intermediate, smaller, or larger value.

[0081] According to some exemplary embodiments, at the final predetermined position of the adjuster, the bone punch moves to be substantially perpendicular to the shaft of the device, as shown, for example, in Figure IE. In some embodiments, when the bone punch is substantially perpendicular to the shaft of the device, the bone punch extends to a maximum distance, which, for example, allows the bone punch to form a bone opening having a width of up to 15 mm, e.g., up to 14 mm, up to 13 mm, up to 12 mm, or any intermediate smaller or larger width, when the bone punch is rotated.

[0082] Exemplary Bone Removal Devices and Portions Thereof Disclosed herein are bone removal devices, such as drilling devices, that are particularly useful for drilling holes in a patient's bone, the diameter of which can be adjusted by the user.

[0083] Reference is now made to Figures 1L and 1M, which are simplified pictorial illustrations of assembled and exploded views, respectively, of a drilling device constructed and operative in accordance with certain exemplary embodiments of the present invention.

[0084] According to some exemplary embodiments, a drilling device, e.g., drilling device 100, is seen in FIGS. 1L and 1M. In some embodiments, as seen, for example, in FIGS. 1L and 1M, drilling device 100 includes a shaft element 102 having a proximal end 104 and a distal end 106. In some embodiments, shaft 102 is disposed along a longitudinal axis 107. In some embodiments, shaft element 102 includes visual scale markings, e.g., visual scale marking 108, on an outer surface thereof to, for example, allow for identification of the depth of penetration of drilling device 100 into the patient's bone.

[0085] According to some exemplary embodiments, for example, as shown in FIG. 1L, device 100 includes a pusher element, e.g., pusher element 110. In some embodiments, pusher element 110 is adapted to be coaxially received within shaft element 102 and defines a proximal end 112 and a distal end 114.

[0086] According to some exemplary embodiments, device 100 comprises a crank, e.g., crank 120, pivotally connected to both distal end 106 of shaft element 102 and distal end 114 of pusher element 110, e.g., by means of pivot pin 122. In some embodiments, crank 120 is in turn pivotally connected to a bone drill, e.g., cutting tooth 130, e.g., by means of pivot pin 132. In some embodiments, the cutting tooth is additionally pivotally connected to distal end 106 of shaft element 102, e.g., by means of an additional pivot pin 134.

[0087] According to some exemplary embodiments, the proximal end 104 of the shaft element 102 is fixedly connected to the cover element 140. In some embodiments, the proximal end 104 of the shaft element 102 is movably connected to a pusher element displacer, such as, for example, a pusher element displacer mechanism 150.

[0088] According to some exemplary embodiments, pusher element displacement mechanism 150 comprises a guide element, e.g., guide element 160, fixedly attached to and optionally coaxially disposed at proximal end 112 of pusher element 110. In some embodiments, guide element 160 is adapted to be partially received within cover element 140. In some embodiments, guide element 160 comprises a plunger encasement socket 162 adapted to receive a plunger 164 therein.

[0089] According to some exemplary embodiments, device 100 includes an adjuster, e.g., an adjustment element, e.g., adjustment element 170, disposed coaxially with and / or at least partially surrounding guide element 160. In some embodiments, adjustment element 170 has visual scale markings 172 on its periphery, e.g., to indicate a desired hole diameter to be formed in the patient's bone.

[0090] According to some exemplary embodiments, device 100 includes a stopper, e.g., stopper element 180, configured to support against a portion of adjustment element 170 and optionally be held in place by means of a nut 182. In some embodiments, nut 182 is biased distally under the force of a spring 184.

[0091] According to some exemplary embodiments, as seen in, for example, FIG. 1M , the device comprises a spring, e.g., spring 184, arranged coaxially with guide element 160 and optionally configured to be received within a socket formed in rotation element 190, e.g., arranged along mutual longitudinal axis 107. In some embodiments, rear cover 192 is adapted to be attached to a portion of rotation element 190 and, optionally, is partially received within adjustment element 170.

[0092] According to some exemplary embodiments, the rotational element 190 is adapted to be attached to a power tool that imparts rotational motion.

[0093] According to some exemplary embodiments, the drilling device 100 provides for forming undercut holes of various diameters, for example, by opening the cutting teeth 130 of the drilling device 100 to different radial extents, as described in detail below. In some embodiments, the adjustment element 170 is rotatable by a user and is adapted to cooperate with the guide element 160 and the pusher element 110, for example, to enable the cutting teeth 130 to open to different radial extents, and thus, optionally, to form undercut holes of various diameters in the patient's bone.

[0094] Exemplary Cutting Teeth Reference is now made to Figures 2A-2C, which are simplified pictorial diagrams and two different plan views, respectively, of cutting teeth, e.g., cutting tooth 130, forming part of the drilling device 100 of Figures 1L and 1M, the drilling device 600 of Figures 19A and 19B, and the drilling device 1000 of Figure 19C, according to some exemplary embodiments of the present invention.

[0095] According to some exemplary embodiments, the cutting teeth, e.g., cutting tooth 130, are integrally fabricated into a generally planar element, e.g., from a biocompatible metal, and optionally disposed along a longitudinal axis 201. In some embodiments, as seen, for example, in FIGS. 2A-2C , cutting tooth 130 has a drilling tip 200 at its distal end and a reaming tip 202 at its proximal end. In some embodiments, drilling tip 200 preferably includes multiple facets 204, which optionally facilitate effective drilling of the patient's bone while advancing distally. In some embodiments, reaming tip 202 preferably has two cutting edges 206, which generally face in opposite directions from one another. In some embodiments, at least one of these cutting edges 206 is adapted to facilitate reaming of a hole resulting from drilling in the bone, e.g., while drilling device 100 is advanced distally. In some embodiments, optionally, hole reaming is provided to enlarge the diameter of the hole drilled in the bone, for example, while the drilling device 100 is being retracted proximally.

[0096] According to some exemplary embodiments, an aperture 210 is formed in the cutting tooth 130 and optionally extends along an axis 212 that is generally perpendicular to the longitudinal axis 201. In some embodiments, the aperture 210 serves as a seat for a pivot axis of the cutting tooth 130. In some embodiments, a pivot, such as the pivot pin 134 shown in FIG. 1M, serves as the pivot axis of the cutting tooth 130. In some embodiments, the aperture 210 is positioned generally closer to the drilling end 200 than to the reaming end 202.

[0097] According to some exemplary embodiments, an additional aperture 212 is formed in the cutting tooth 130, which is adapted to receive the pivot pin 132 shown in FIG. 1M and configured to pivotally connect the cutting tooth 130 to the crank 120.

[0098] Exemplary crank Reference is now made to Figures 3A-3C, which are simplified pictorial views and two different plan views, respectively, of a crank, e.g., crank 120, forming part of the drilling device 100 of Figures 1L and 1M, the drilling device 600 of Figures 19A and 19B, and the drilling device 1000 of Figure 19C, according to some exemplary embodiments of the present invention.

[0099] According to some exemplary embodiments, crank 120 is a unitarily constructed element, for example, made of a biocompatible metal. In some embodiments, crank 120 has a distal end 220 and a proximal end 222. In some embodiments, distal end 220 has a pair of spaced-apart hooks 224. In some embodiments, each of hooks 224 has an aperture 226 therein. In some embodiments, proximal end 222 also includes a pair of spaced-apart hooks 228. In some embodiments, each of hooks includes an aperture 230 therein.

[0100] According to some exemplary embodiments, aperture 226 is configured to receive pivot pin 132 to connect it with cutting tooth 130, as shown, for example, in FIG. 1M. In some embodiments, aperture 230 is configured to receive a pivot, e.g., pivot pin 122, for connection with, for example, pusher element 110 and shaft element 102, as shown in FIG. 1M.

[0101] Exemplary Pusher Reference is now made to Figures 4A-4C, which are simplified pictorial diagrams and two different plan views, respectively, of a pusher element, e.g., pusher element 110, forming part of the punching device 100 of Figures 1L and 1M, the punching device 600 of Figures 19A and 19B, and the punching device 1000 of Figure 19C, according to some exemplary embodiments of the present invention.

[0102] According to some exemplary embodiments, the pusher, e.g., pusher element 110, is a unitarily formed cylindrical element, optionally made of a biocompatible metal. In some implementations, pusher element 110 is disposed along longitudinal axis 107. In some embodiments, pusher element 110 comprises proximal end 112, distal end 114, and optionally flange 240. In some embodiments, flange 240 extends distally from distal end 114 along longitudinal axis 107. In some embodiments, aperture 242 is formed through flange 240 and optionally extends along an axis that is generally perpendicular to axis 107. In some embodiments, aperture 242 is configured to receive pivot pin 122, for example, for connection of pusher element 110 to crank 120, and thus, optionally, cutting tooth 130.

[0103] Exemplary Shaft Reference is now made to Figures 5A-5D, which are respectively a simplified pictorial view and two different plan views of a shaft element, e.g., shaft element 102, forming part of the drilling apparatus 100 of Figures 1L & 1M, the drilling apparatus 600 of Figures 19A & 19B, and the drilling apparatus 1000 of Figure 19C, according to some exemplary embodiments of the present invention.

[0104] According to some exemplary embodiments, the shaft, e.g., shaft element 102, is a unitarily fabricated hollow cylindrical element, optionally made of a biocompatible metal, disposed along a longitudinal axis 107. In some embodiments, shaft element 102 has a proximal end 104 and a distal end 106, e.g., as described above. In some embodiments, shaft element 102 includes visual scale markings 108 on its outer surface, e.g., to allow for identification of the depth of penetration of drilling device 100 into the patient's bone.

[0105] According to some exemplary embodiments, the shaft element 102 has a relatively long first notch 250 disposed at its distal end 106 and optionally extending proximally from the distal end 106. In some embodiments, a second notch 252, which is optionally shorter than the first notch 250, is disposed generally diametrically opposite the first notch 250. In some embodiments, a pair of apertures 254 are formed in the distal end 106 of the shaft element 102 disposed between the notches 250 and 252. In some embodiments, the pair of apertures 254 are disposed along an axis generally perpendicular to the longitudinal axis 107. In some embodiments, the openings 254 are adapted to receive a pivot, e.g., a pivot pin 122, for connection of, e.g., the crank 120 to the pusher element 110 and the shaft element 102, as shown, for example, in FIG. 1M .

[0106] According to some exemplary embodiments, the distal end of the shaft, e.g., distal end 106 of shaft 102, includes a separate distal portion having an opening shaped and sized to position a movable bone drill within the opening. In some embodiments, the separate distal portion is fixedly coupled to the shaft by welding, adhesive bonding, and / or soldering. In some embodiments, the separate distal portion is formed from a material different from the material used to form the shaft. In some embodiments, the distal portion is formed from a hardened material, e.g., to increase the distal portion's resistance to torsional forces. In some embodiments, the separate distal portion is made from a different Nirosta, Titanium, Zarconium, or other medical-grade metal.

[0107] Exemplary Cover Reference is now made to Figures 6A-6C, which are respectively a simplified pictorial view, a plan view, and a cross-sectional view along line CC of Figure 6B of a cover element, such as cover element 140, forming part of the perforation device 100 of Figures 1L and 1M, according to some exemplary embodiments of the present invention.

[0108] According to some exemplary embodiments, the cover, e.g., cover element 140, is a unitarily formed element, optionally made of plastic. In some implementations, cover 140 is disposed along longitudinal axis 107. In some embodiments, cover element 140 has a distal generally conical portion 270 and a proximal generally cylindrical portion 272. In some embodiments, cylindrical portion 272 has markings 274 formed on an outer surface thereof. In some embodiments, markings 274 are configured to cooperate with scale markings 172 formed on adjustment element 170.

[0109] According to some exemplary embodiments, as seen in, for example, Figure 6C, a bore, e.g., bore 280, is formed in conical portion 270 and extends along longitudinal axis 107, e.g., to receive proximal end 112 of pusher element 110. In some embodiments, bore 280 has a first diameter sized for the shaft.

[0110] According to some exemplary embodiments, bore 282 is formed proximal to bore 280, optionally within cylindrical portion 272, and in communication with bore 280. In some embodiments, bore 282 has a second diameter.

[0111] In some embodiments, the second diameter is generally larger than the first diameter. In some embodiments, the bore 282 extends along the longitudinal axis 107 and is adapted to partially receive the guide element 160.

[0112] According to some exemplary embodiments, an additional bore 284 is disposed transversely to bore 282. In some implementations, bore 284 extends partially along the longitudinal extent of bore 282 and along an axis generally parallel to axis 107. In some embodiments, bore 284 is configured to communicate with bore 282 and is optionally adapted to receive plunger-enclosed socket 162 of guide element 160.

[0113] Exemplary Guide Elements Reference is now made to Figures 7A-7C, which are simplified pictorial and plan and cross-sectional views, respectively, of a guide element, such as guide element 160, forming part of the drilling device 10 of Figures 1L & 1M, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line CC of Figure 7B.

[0114] According to some exemplary embodiments, the guide elements, for example guide element 160, are integrally made elements, optionally made from metal, and are disposed along longitudinal axis 107.

[0115] In some embodiments, guide element 160 is a generally cylindrical element having a distal end 290, a proximal end 292, and optionally a plunger entrapment socket 162. In some embodiments, plunger entrapment socket 162 is formed on the outer periphery of guide element 160, optionally adjacent its distal end 290.

[0116] In some embodiments, the plunger encapsulation socket 162 defines a through hole 294, which is optionally adapted to securely hold the connector 164 therein, for example, for cooperation with the adjustment element 170.

[0117] 7C , guide element 160 has two diametrically opposed guide notches 296 extending distally from its proximal end 292. In some embodiments, the two diametrically opposed guide notches 296 are adapted to receive a portion of stop element 180. In some embodiments, at least one of the notches terminates in an arcuate end surface 297.

[0118] According to some exemplary embodiments, as seen in FIG. 7C , bore 298 extends proximally from distal end 290 of guide element 160. In some embodiments, bore 298 extends along longitudinal axis 107. In some embodiments, bore 298 has a first diameter and is optionally adapted to receive a portion of proximal end 112 of pusher element 110. In some embodiments, bore 300 is formed proximal to and in communication with bore 298. In some embodiments, bore 300 extends proximally along longitudinal axis 107 from bore 298 toward proximal end 292 of guide element 160 and has a second diameter, optionally larger than the first diameter. In some embodiments, the second diameter of bore 300 is adapted to receive a portion of rotation element 190. In some embodiments, a wider bore portion 302 is formed at the proximal end of bore 300, which optionally defines a proximally facing shoulder 304.

[0119] Exemplary Adjustment Factors Reference is now made to Figures 8A-8E, which are respectively a simplified pictorial view, three different plan views, and a cross-sectional view of an adjustment element, such as adjustment element 170, forming part of the drilling device 100 of Figures 1L and 1M, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line EE of Figure 8C.

[0120] According to some exemplary embodiments, the adjuster, e.g., adjustment element, e.g., adjustment element 170, is an integrally made element, optionally made from plastic, that is positioned along the longitudinal axis 107.

[0121] In some embodiments, the adjustment element 170 is a generally cylindrical or barrel-shaped element having a distal end 320 and a proximal end 322. In some embodiments, the adjustment element has an outer gripping surface 324 with scale markings 172 formed thereon, for example, to indicate the desired diameter of the resulting hole. In some embodiments, there is also a scale mark 326 adjacent the distal end 320 of the adjustment element 170, which is adapted to optionally cooperate with the markings 274 on the cover element 140, for example, to indicate to a user what the selected diameter is.

[0122] According to some exemplary embodiments, a variable diameter hole, such as variable diameter hole 330, is formed along adjustment element 170 and optionally extends along longitudinal axis 107. In some embodiments, hole 330 has a distal hole portion 332, a central hole portion 334, and a proximal hole portion 336.

[0123] In some embodiments, the proximal bore portion 336 and the distal bore portion 332 both have a substantially similar first diameter, and the central bore portion 334 optionally has a second diameter that is generally smaller than the first diameter.

[0124] In some embodiments, the proximal bore portion 336 defines a proximally-facing circumferential shoulder 340 optionally adapted to engage the stopper element 180. In some embodiments, the distal bore portion 332 defines a distally-facing helical adjustment path 350. In some embodiments, the helical adjustment path 350 includes a plurality of steps 352, each successive step having a different height, and each successive step 352 optionally being spaced a different distance from the distal end 320 of the adjustment element 170. In some embodiments, the adjustment path 350 includes a first step 352 closest to the distal end 320 of the adjustment element 170, and optionally, each successive step 352 is progressively further away from the distal end 320. In some embodiments, the range of height difference between any successive steps is in the range of 0.5 mm to 5 mm, e.g., 0.5 mm to 3 mm, 2 mm to 4 mm, 2 mm to 5 mm, or any intermediate, smaller or larger range of values. Alternatively, the range of height difference between each step 352 is smaller or larger depending on the required medical application.

[0125] In some embodiments, as seen, for example, in Figures 8A and 8B, each step 352 includes a recess 354 optionally adapted to engage a portion of plunger 164, as shown in Figure 1M.

[0126] Exemplary Stopper Elements Reference is now made to Figures 9A-9B, which are simplified pictorial and plan views, respectively, of a stopper element, e.g., stopper element 180, forming part of the drilling rig 100 of Figures 1L and 1M, according to some exemplary embodiments of the present invention.

[0127] According to some exemplary embodiments, the stopper element, for example stopper element 180, is an integrally made flat element, optionally made from plastic, and arranged along longitudinal axis 107.

[0128] According to some exemplary embodiments, stop element 180 has a central, generally annular portion 370 having a hole 372 formed therethrough, optionally extending along longitudinal axis 107. In some embodiments, two longitudinal arms 374 extend radially from annular portion 370. In some embodiments, stop element defines a distally facing surface 376 and a proximally facing surface 378.

[0129] Exemplary Rotational Elements 10A-10C, which are simplified pictorial, plan, and cross-sectional views of a rotating element 190 forming part of the drilling device 100 of FIGS. 1L and 1M, according to some embodiments of the present invention, the cross-sectional view being taken along line CC of FIG. 10B.

[0130] According to some exemplary embodiments, the rotational elements, for example, rotational element 190, are integrally fabricated elements, optionally fabricated from and positioned along longitudinal axis 107.

[0131] In some embodiments, the rotation element 190 has a proximal portion 390 of a first diameter and is optionally adapted to be connected to a power tool, for example, to impart rotational motion from the power tool to the drilling device 100. In some embodiments, the rotation element 190 further has a central portion 392 of a second diameter substantially larger than the first diameter, and a distal portion 394 of a third diameter, optionally substantially smaller than the second diameter and optionally larger than the first diameter. In some embodiments, the distal portion 394 is adapted to be fixedly connected to the guide element 160, for example, to enable imparting rotation from the power tool to the drilling device 100.

[0132] According to some exemplary embodiments, a distally facing shoulder 396 is defined between the central portion 392 and the distal portion 394. In some embodiments, the distal end portion further defines a distally facing end surface 397.

[0133] In some embodiments, as seen, for example, in FIG. 10C , a longitudinal blind bore 398 is formed in rotating element 190 and extends longitudinally along axis 107 through distal portion 394 and at least a portion of central portion 392. In some embodiments, bore 398 is adapted to receive spring 184 therein, as shown, for example, in FIG. 1M .

[0134] Exemplary Perforation Device Referring now to Figures 11A-11C, Figures 11A-11C are two different simplified plan and cross-sectional views, respectively, of the drilling device 100 of Figures 1L and 1M according to some exemplary embodiments of the present invention, not showing the drilling device subassembly, e.g., the adjustment element 170 of Figures 8A-8E, where the cross-sectional views are taken along line CC of Figure 11B.

[0135] According to some exemplary embodiments, as seen, for example, in FIGS. 11A-11C, the cutting teeth 130 are in their closed operating orientation.

[0136] According to some exemplary embodiments, guide element 160 is optionally partially received within cover element 140 such that distal end 290 of guide element 160 seats within bore 282 of cover element 140. In some embodiments, plunger encasement socket 162 of guide element 160 seats within bore 284 of cover element 140. In some embodiments, proximal end 292 of guide element 160 is fixedly connected to distal portion 394 of rotation element, and rear cover 192 is optionally fixedly coupled to central portion 392 of rotation element 190. In some embodiments, shaft element 102 is optionally fixedly connected to cover element 140 such that proximal end 104 of shaft element 102 is inserted into bore 280 of cover element 140. In some embodiments, pusher element 110 is partially enclosed within shaft element 102 and optionally positioned such that proximal end 112 of the pusher element extends proximally relative to proximal end 104 of shaft element 102 .

[0137] According to some exemplary embodiments, as seen in FIG. 11C , stopper element 180 is fixedly connected to pusher element 110, with pusher element 110 optionally extending through bore 372 in stopper element 180. In some implementations, stopper element 180 is threaded onto pusher element 110 (not shown) and optionally fixedly attached thereto by means of nut 184 that engages a proximally-facing surface 378 of stopper element 180. In some embodiments, spring 184 is seated within bore 398 in rotating element 190 and configured to distally bias stopper element 180. In some embodiments, distal end 106 of shaft 106 and distal end 114 of pusher element 110 are connected to crank 120, for example, by means of pivot pin 122. In some embodiments, crank 120 is pivotally connected to cutting tooth 130, for example, by means of pivot pin 132. In some embodiments, the cutting teeth 130 are pivotally connected to the distal end 106 of the shaft element 102, which optionally has two notches 250 and 252 that allow for, for example, radial extension of the cutting teeth 130.

[0138] According to some exemplary embodiments, stopper element 180 and pusher element 110 are fixedly attached and, therefore, in some embodiments, movable together, and stopper element 180 and pusher element 110 are slidably axially movable together relative to guide element 160. Optionally, longitudinal arm 374 of stopper element 180 is slidably movable along notch 296 in the guide element. In some embodiments, when longitudinal arm 374 engages end face 297 of notch 296, cutting tooth 130 is positioned in its fully open operating orientation.

[0139] According to some exemplary embodiments, the cutting teeth 130 are the distal-most components of the drilling device 100 and extend distally relative to the distal end 106 of the shaft element 102. In some embodiments, the cutting teeth 130 function as drilling tips.

[0140] Reference is now made to Figures 12A and 12B, which are plan and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, e.g., the drilling device 100 of Figures 1L and 1M shown in a closed operating orientation prior to insertion into a patient's bone, the cross-sectional view being along line BB of Figure 12A.

[0141] According to some exemplary embodiments, Figures 12A and 12B show the drilling device in a closed operating orientation, in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, and are optionally adapted in this orientation to drill an initial hole in the patient's bone 500, optionally while advancing the drilling device 100 distally through the patient's bone 500, for example, using the drilling end 200.

[0142] In some embodiments, all spatial relationships between the different components of the punching device 100 remain substantially the same as those described with reference to FIGS. 11A-11C, except for the following relationships:

[0143] In some embodiments, adjustment element 170 is coaxially mounted on guide element 160 such that guide element 160 extends through distal bore portion 332, central bore portion 334, and proximal bore portion 336 of adjustment element 170. In some embodiments, proximally-facing circumferential shoulder 340 of adjustment element 170 optionally always bears against three distally-facing surfaces 376 of stopper element 180, and longitudinal arm 374 of stopper element 180 is disposed within, and optionally slidably movable along, notch 296 of guide element 160. In some embodiments, stopper element 180 is biased into engagement with shoulder 340 of adjustment element 170, for example, under the force of spring 184 exerting a force on proximally-facing surface 378 of stopper element 180.

[0144] According to some exemplary embodiments, the axial displacement of the adjustment element 170, and in turn the axial displacement of the stop element 180, is biased by an axial force applied by the spring 184 to the stop element 180, and thus also to the pusher element 110. In some embodiments, the axial force of the spring 184 allows the cutting teeth 130 to extend radially relative to the shaft element 102, and optionally, the range of radial extension of the cutting teeth is defined by the range of rotation of the adjustment element 170.

[0145] In some embodiments, the adjustment element 170 is mounted above the guide element 160 so that the plunger 164 seated in the plunger-encapsulated socket 162 of the guide element 160 engages with one of the steps 352 of the spiral adjustment path 350 of the adjustment element 170.

[0146] According to some exemplary embodiments, plunger 164 includes a housing 502 within which is disposed a ball 504 that is optionally proximally biased under the force of a spring 506, and thus securely engaged with a particular step of helical adjustment path 350. It is understood that any other type of plunger may be used to selectively operably engage one of the steps 352 of adjustment path 350.

[0147] According to some exemplary embodiments, the adjustment element 170 is freely rotatable relative to other components of the drilling apparatus 100. In some embodiments, as the adjustment element 170 rotates relative to the guide element 160, the plunger 164 engages another one of the steps 352 of the helical adjustment path 350 of the adjustment element 170, optionally positioned at a different height than the previous step 352, thus providing axial displacement of the adjustment element 170 relative to the guide element 160.

[0148] In some embodiments, with each incremental rotation of the adjustment element 170 by the user, the plunger 164 engages another one of the steps 352 of the adjustment path 350, for example, by the ball 504 of the plunger 164 engaging a recess 354 formed in the step 352. Thus, in some embodiments, the height of the step 352 with which the plunger 164 is operatively associated at any given moment defines the extent of the radial extension of the cutting teeth relative to the outer periphery of the shaft element 102.

[0149] According to some exemplary embodiments, upon axial displacement of the adjustment element 170 relative to the guide element 160, the stop element 180, which is operably engaged with the shoulder 340 of the adjustment element 170, is optionally biased to be displaced along with the adjustment element 170, such that the longitudinal arm 374 of the stop element 180 is slidably movable along the notch 296 of the guide element 160. In some embodiments, the axial displacement of the stop element 170 in turn prompts axial displacement of the pusher element 110, which optionally causes corresponding pivoting of the crank 120, which in turn causes pivoting of the cutting teeth 130, which, upon proximal displacement of the drilling device 100 within the patient's bone 500, defines the resulting diameter of the hole in the patient's bone 500.

[0150] According to some exemplary embodiments, adjustment element 170 is disposed between stopper element 180 and plunger 164 formed on guide element 160. In some embodiments, while rotating adjustment element 170, and thus changing the axial position of adjustment element 170 relative to guide element 160 due to engagement of plunger 164 with helical adjustment path 350, adjustment element 170 biases axial displacement of stopper element 180 along notch 296 of guide element 160, and thus, optionally, causes axial displacement of pusher element 110, which in turn controls the radial orientation of cutting teeth 130.

[0151] In some embodiments, the pusher element displacement mechanism 150 of the adjustable punching device 100 is based on axial displacement of components of the punching device 100 along the longitudinal axis 107 .

[0152] 12A and 12B , in the closed operating orientation, the stop element 180 is spaced proximally from the edge 297 of the notch 296 in the guide element 160, and thus, optionally, the pusher element 110 is disposed in its distal position, and optionally, the cutting teeth 130 in this position are closed and do not extend from the outer periphery of the shaft element 102. In some embodiments, this position is adapted to advance the drilling device 100 distally to form an initial hole in the patient's bone 500.

[0153] According to some exemplary embodiments, alignment between the markings 274 formed on the cover element 140 and the scale markings 172 on the adjustment element 170 indicates to the user the currently adjusted diameter.

[0154] In some embodiments, during assembly of the drilling device, the stop element 180 is threaded onto the pusher element 110 to allow for any desired longitudinal range, for example, to allow for initial calibration of the adjustable drilling device 100.

[0155] Reference is now made to Figures 13A and 13B, which are simplified plan and cross-sectional views, respectively, of a drilling device, e.g., the drilling device 100 of Figures 1L and 1M, shown in a closed operating orientation following forward drilling into a patient's bone 500, in accordance with some exemplary embodiments of the present invention, the cross-sectional view being taken along line BB of Figure 13A.

[0156] 13A and 13B show the drilling device 100 in a closed operating orientation, in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, and are adapted in this orientation to optionally drill an initial hole in the patient's bone 500, for example, using the drilling end 200, while the drilling device 100 is advanced distally through the patient's bone 500. In some embodiments, for example, as shown in FIGS. 13A and 13B, the drilling device 100 is advanced distally through the patient's bone 500, and an initial hole 510 of a first diameter is formed in the bone 500.

[0157] It should be noted that in some embodiments, all other spatial relationships between the different components of the punching device 100 remain substantially the same as those described with reference to Figures 12A and 12B.

[0158] In some embodiments, the drilling of the initial hole 510 is performed using the drilling end 200 of the cutting tooth 130 .

[0159] Now, reference is made to Figures 14A and 14B, which are simplified plan and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, for example, the drilling device 100 of Figures 1L and 1M shown in a first partially open operating orientation inserted into a patient's bone 500, the cross-sectional view being taken along line BB of Figure 14A.

[0160] According to some exemplary embodiments, as seen, for example, in Figures 14A and 14B, the drilling device 100 is in a first partially open operating orientation, in which the cutting teeth 130 extend slightly radially from the outer surface of the shaft element 102, and in this orientation is adapted to, for example, use the reaming end 202 to ream an undercut hole having a diameter of 6 mm in the patient's bone 500, while optionally advancing the drilling device 100 proximally backward through the patient's bone 500.

[0161] 14A and 14B, the adjustment element 170 is rotated by the user, so that the scale markings 326 on the adjustment element indicate that the desired diameter is 6 mm. This is because the markings 326 corresponding to 6 mm are aligned with the markings 274 on the cover element 140. In some embodiments, once the adjustment element 170 is rotated, the plunger 164 operably engages another one of the steps 352 of the adjustment path 350, as described in detail with reference to FIGS. 12A and 12B, and thus the adjustment element 170 is slightly axially displaced in the distal direction, thereby optionally causing a distal axial displacement of the stopper element 180 under the force of the spring 184, and optionally also displacing the pusher element 110, which moves with the stopper element 180, distally.

[0162] In some embodiments, as seen for example in FIG. 14B, the stop element 180 is now not spaced distally from the edge 297 of the notch 296 in the guide element 160 as compared to FIG. 12B.

[0163] According to some exemplary embodiments, upon distal displacement of pusher element 110, crank 120 is pivoted about pin 122, and optionally, cutting tooth 130 is pivoted about its pivot axis, which is pivot pin 134. In some embodiments, pivoting of cutting tooth 130 about pivot pin 134 causes reaming end 202 of cutting tooth 130 to engage patient's bone 500, thus optionally widening the diameter of initial hole 510 to undercut hole 520 during proximal advancement of drilling device 100. Undercut hole 520 has a diameter of 6 mm in this particular example.

[0164] It should be noted that in some embodiments, the pivot axis 134 is positioned closer to the drilling end 200 than the reaming end 202, and therefore the reaming end of the cutting tooth is longer than the drilling end 200, thereby enabling, for example, effective engagement of the reaming end 202 with the initial hole 510.

[0165] In some embodiments, pivoting the cutting teeth about pivot axis 134 causes the cutting teeth 130 to extend radially from the outer periphery of the shaft element 102. In some embodiments, the drilling end 200 of the cutting teeth 130 extends radially through a notch 250 in the shaft element 102, and the reaming end 202 simultaneously extends radially through a notch 252 in the shaft element 102.

[0166] It should be noted that in some embodiments, the fact that the cutting teeth 130 are the most distal component of the drilling device 100 allows for precise formation of the undercut holes 520 .

[0167] It should be noted that in some embodiments, all other spatial relationships between the different components of the punching device 100 remain substantially the same as those described with reference to Figures 12A and 12B.

[0168] Reference is now made to Figures 15A and 15B, which are simplified plan and cross-sectional views, respectively, of a drilling device, e.g., the drilling device 100 of Figures 1L and 1M, shown in a second, partially open operating orientation inserted into a patient's bone 500, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line BB of Figure 15A.

[0169] According to some exemplary embodiments, as seen, for example, in Figures 15A and 15B, the drilling device 100 is in a second, partially open operating orientation, in which the cutting teeth 130 optionally extend more radially from the outer surface of the shaft element 102, and in this orientation is adapted to, for example, use the reaming end 202 to ream an undercut hole having a diameter of 9 mm in the patient's bone 500, while optionally advancing the drilling device 100 proximally backward through the patient's bone 500.

[0170] According to some exemplary embodiments, as seen in, for example, FIGS. 15A and 15B , adjustment element 170 is now rotated by the user so that, for example, marking 326 corresponding to 9 mm aligns with marking 274 on cover element 140, and thus scale marking 326 on adjustment element 170 indicates that the desired diameter is 9 mm. In some embodiments, once adjustment element 170 is rotated, plunger 164 optionally operably engages another one of steps 352 of adjustment path 350, as described in detail with reference to, for example, FIGS. 12A and 12B , and thus adjustment element 170 is optionally slightly more axially displaced distally, thereby optionally causing distal axial displacement of stop element 180 under the force of spring 184, which in turn displaces pusher element 110, which moves with stop element 180, distally as well.

[0171] In some embodiments, as seen for example in FIG. 15B, stop element 180 is now spaced less distally from edge 297 of notch 296 in guide element 160 compared to FIG. 14B.

[0172] In some embodiments, distal displacement of pusher element 110 causes crank 120 to pivot about pin 122, which in turn causes cutting tooth 130 to pivot about its pivot axis, which is pivot pin 134. In some embodiments, as cutting tooth 130 pivots about pivot pin 134, reaming end 202 of cutting tooth 130 optionally engages the patient's bone 500, thus widening the diameter of initial hole 510 to undercut hole 530 during proximal advancement of drilling device 100. Undercut hole 530 has a diameter of 9 mm in this particular example.

[0173] In some embodiments, the pivot axis 134 is positioned closer to the drilling end 200 than the reaming end 202, and therefore the reaming end of the cutting tooth is optionally longer than the drilling end 200, thereby enabling effective engagement of the reaming end 202 with the initial hole 510.

[0174] In some embodiments, pivoting the cutting tooth 130 about the pivot axis 134 causes the cutting tooth 130 to extend radially from the outer periphery of the shaft element 102. In some embodiments, the drilling end 200 of the cutting tooth 130 extends radially through a notch 250 in the shaft element 102, and the reaming end 202 optionally simultaneously extends radially through a notch 252 in the shaft element 102.

[0175] In some embodiments, the fact that cutting teeth 130 are the most distal component of drilling device 100 allows for precise formation of undercut holes 530, for example.

[0176] It should be noted that in some embodiments, all other spatial relationships between the different components of the punching device 100 remain substantially the same as those described with reference to Figures 12A and 12B.

[0177] Reference is now made to Figures 16A and 16B, which are simplified plan and cross-sectional views, respectively, of a drilling device, e.g., the drilling device 100 of Figures 1L and 1M, shown in a fully open operating orientation inserted into a patient's bone 500, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line BB of Figure 16A.

[0178] According to some exemplary embodiments, as seen, for example, in FIGS. 16A and 16B , the drilling device 100 is in a fully open operating orientation, with the cutting teeth 130 optionally extending radially further from the outer surface of the shaft element 102 and, in this orientation, adapted to ream an undercut hole having a diameter of 12 mm in the patient's bone 500 using the reaming end 202 while advancing the drilling device 100 rearwardly in a proximal direction through the patient's bone 500.

[0179] 16A and 16B, adjustment element 170 is now rotated by the user so that, for example, marking 326 corresponding to 12 mm is aligned with indicia 274 on cover element 140, thereby causing scale marking 326 on adjustment element 170 to indicate that the desired diameter is 12 mm. In some embodiments, once adjustment element 170 is rotated, plunger 164 operably engages another one of steps 352 of adjustment path 350, as described in detail with reference to FIGS. 12A and 12B, and thus adjustment element 170 is axially displaced distally, thereby optionally causing distal axial displacement of stop element 180 under the force of spring 184, which in turn displaces pusher element 110, which moves with stop element 180, distally as well.

[0180] In some embodiments, for example, as seen in FIG. 16B, compared to FIG. 15B, the stopper element 180 now engages with an edge 297 of a notch 296 in the guide element 160.

[0181] In some embodiments, upon distal displacement of pusher element 110, crank 120 is pivoted about pin 122, and cutting tooth 130 is optionally pivoted about its pivot axis, which is pivot pin 134. In some embodiments, pivoting of cutting tooth 130 about pivot pin 134 causes reaming end 202 of cutting tooth 130 to engage patient's bone 500, thus optionally widening the diameter of initial hole 510 to undercut hole 540, for example, during proximal advancement of drilling device 100. In some embodiments, undercut hole 540 has a diameter of 12 mm in this particular example.

[0182] In some embodiments, the pivot 134 is positioned closer to the drilling end 200 than the reaming end 202, and therefore the reaming end of the cutting tooth is optionally longer than the drilling end 200, thereby, for example, enabling effective engagement of the reaming end 202 with the initial hole 510.

[0183] In some embodiments, the cutting tooth 130 optionally extends radially from the outer periphery of the shaft element 102 upon pivoting the cutting tooth about the pivot axis 134. In some embodiments, the piercing end 200 of the cutting tooth 130 extends radially through a notch 250 in the shaft element 102, and the reaming end 202 simultaneously extends radially through a notch 252 in the shaft element 102.

[0184] It should be noted that in some embodiments, the fact that cutting teeth 130 are the most distal component of drilling device 100 allows for precise formation of undercut holes 540, for example.

[0185] It should be noted that in some embodiments, all other spatial relationships between the different components of the drilling apparatus 100 remain substantially the same as those described with reference to Figures 12A and 12B.

[0186] Reference is now made to Figures 17A and 17B, which are simplified plan and cross-sectional views, respectively, of a drilling device, e.g., the drilling device 100 of Figures 1L and 1M, shown in a closed operating orientation prior to removal from the patient's bone 500, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line BB of Figure 17A.

[0187] According to some exemplary embodiments, as seen in Figures 17A and 17B, for example, in a fully closed operating orientation in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, the drilling device 100 is adapted to be retracted proximally while being withdrawn from the patient's bone 500. Figures 17A and 17B show the drilling device 100 prior to retraction from the patient's bone 500.

[0188] 17A and 17B, the adjustment element 170 is rotated by the user so that the marking 326 corresponding to 3.5 mm aligns with the marking 274 on the cover element 140, thereby causing the scale marking 326 on the adjustment element to indicate that the desired diameter is 3.5 mm. In some embodiments, once the adjustment element 170 is rotated, the plunger 164 operably engages another one of the steps 352 of the adjustment path 350, as described in detail with reference to FIGS. 12A and 12B, and thus, optionally, the adjustment element 170 is axially displaced proximally, thereby causing a proximal axial displacement of the stopper element 180, which in turn displaces the pusher element 110, which moves with the stopper element 180, proximally as well.

[0189] In some embodiments, as seen for example in FIG. 17B, the stop element 180 is now spaced proximally from the edge 297 of the notch 296 in the guide element 160 as compared to FIG. 16B.

[0190] It should be noted that in some embodiments, all other spatial relationships between the different components of the punching device 100 remain substantially the same as those described, for example, with reference to Figures 12A and 12B.

[0191] Reference is now made to Figures 18A and 18B, which are simplified plan and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, for example, the drilling device 100 of Figures 1L and 1M shown in a closed operating orientation after removal from the patient's bone 500, the cross-sectional view being along line BB of Figure 18A.

[0192] According to some exemplary embodiments, as seen in, for example, Figures 18A and 18B, the drilling device 100 is in a fully closed operating orientation, in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, and is adapted to withdraw the drilling device 100 from the patient's bone 500, while optionally retracting the drilling device 100 proximally. Figures 18A and 18B show the drilling device 100 after retraction from the patient's bone 500, while the resulting initial hole 510 and undercut hole 520 are clearly visible as they are formed in the patient's bone 500.

[0193] Reference is now made to Figures 19A and 19B, which are simplified pictorial illustrations of assembled and exploded views, respectively, of a drilling apparatus constructed and operative in accordance with certain exemplary embodiments of the present invention.

[0194] In some embodiments, a perforation device 600 is shown in Figures 19A and 19B.

[0195] According to some exemplary embodiments, as seen in, for example, Figures 19A and 19B, drilling device 600 includes a shaft element 102 having a proximal end 104 and a distal end 106. In some embodiments, shaft 102 is disposed along a longitudinal axis 107. In some embodiments, shaft element 102 includes visual scale markings 108 on its outer surface to, for example, allow for identification of the depth of penetration of drilling device 600 into the patient's bone.

[0196] According to some exemplary embodiments, the pusher element 110 is adapted to be coaxially received within the shaft element 102 and defines a proximal end 112 and a distal end 114. In some embodiments, the crank 120 is pivotally connected to the cutting teeth 130 and the distal end 114 of the pusher element 110, for example, by means of a pivot pin 122. In some embodiments, the crank 120 is pivotally coupled to the cutting teeth 130, for example, by means of a pivot pin 132. In some embodiments, the cutting teeth are additionally pivotally connected to the distal end 106 of the shaft element 102, for example, by means of an additional pivot pin 134.

[0197] According to some exemplary embodiments, the proximal end 104 of the shaft element 102 is fixedly connected to the retainer 660 and is optionally partially inserted into the cover element 640. In some embodiments, the proximal end 112 of the pusher element 110 is fixedly connected to at least a portion of the pusher element displacement mechanism 650, while the pusher element 110 is movable relative to the shaft element 102.

[0198] According to some exemplary embodiments, pusher element displacement mechanism 650 includes a retainer 660. In some embodiments, proximal end 112 of pusher 110 is at least partially inserted through an opening formed in retainer 660. In some implementations, pusher element 110 is movable relative to, and optionally coaxial with, retainer 660. In some embodiments, retainer 660 is adapted to be received between two portions of cover element 640. In some embodiments, retainer 660 is adapted to receive a cam connector 662 therein. In some embodiments, cam connector 662 is movable relative to, and optionally coaxial with, retainer 660. In some embodiments, cam connector 662 is adapted to be fixedly attached to proximal end 112 of pusher element 110, for example, by means of a fastener 664.

[0199] According to some exemplary embodiments, an adjuster, e.g., adjustment element 670, is partially mounted within cam connector 662 and, optionally, coupled thereto in a cam interface manner by means of pin 674. In some embodiments, adjustment element 670 has visual scale markings 672 around its periphery, e.g., to indicate the desired hole diameter to be formed in the patient's bone. In some embodiments, the center of adjustment element 670 is fixedly attached to retainer 660 by means of pin 676. In some embodiments, the device comprises one or more adjuster retainers, e.g., leaf springs 680, adapted to be disposed on each side of adjustment element 670 and configured to hold adjustment element 670 securely in place. Alternatively, one or more adjuster retainers comprise plungers, which may be adapted to be disposed on each side of adjustment element 670 and configured to hold adjustment element 670 securely in place.

[0200] In some embodiments, bit connector 690 is adapted to be fixedly connected at its distal end to retainer 660 and adapted to be attached at its proximal end to a power tool. In some embodiments, the power tool is configured to impart rotational motion to the bit connector and further to shaft element 102.

[0201] In some embodiments, the drilling device 600 forms undercut holes of various diameters, for example, by opening the cutting teeth 130 of the drilling device 600 to different radial ranges, as described in detail below. In some embodiments, an adjustment element 670 is preferably rotatable by a user in the direction of the longitudinal axis 107 and is optionally adapted to cooperate with the cam connector 662 and thereby the pusher element 110, which cooperation enables the cutting teeth 130 to open to different radial ranges, and thus form undercut holes of various diameters in the patient's bone.

[0202] Reference is now made to FIG. 19C, which is a simplified pictorial illustration of an exploded view of a drilling device having an adjuster retainer, eg, a plunger, interacting with an adjustment element, according to some exemplary embodiments of the present invention.

[0203] According to some exemplary embodiments, as seen, for example, in FIG. 19C, a perforation device, e.g., perforation device 1000, includes a shaft, e.g., a shaft element 102 having a distal end 106 and a proximal end 104, as further described in FIGS. 19A and 19B.

[0204] According to some exemplary embodiments, the device 1000 further comprises a movable coupler, e.g., a pusher element 110 coupled to the shaft element 102. In some embodiments, the pusher element 110 is adapted to be coaxially received within the shaft element 102 and defines a proximal end 112 and a distal end 114. In some embodiments, the device 1000 comprises a crank, e.g., crank 120, pivotally connected to a bone drill, e.g., a cutting tooth 130. In some embodiments, the crank 120 is pivotally connected to the distal end 114 of the pusher element 110, e.g., by means of a pivot pin 122. In some embodiments, the crank 120 is pivotally coupled to the cutting tooth 130, e.g., by means of a pivot pin 132. In some embodiments, the cutting tooth is additionally pivotally connected to the distal end 106 of the shaft element 102, e.g., by means of an additional pivot pin 134.

[0205] According to some exemplary embodiments, shaft 102, e.g., proximal end 104 of shaft 102, is fixedly connected to a retainer, e.g., retainer 660. Optionally, proximal end 104 is at least partially inserted into a cover formed from optionally complementary cover portions, cover portions 1008 and 1014, e.g., cover 1029 shown in FIG. 24I. In some embodiments, proximal end 112 of pusher element 110 is connected, e.g., fixedly connected, to at least a portion of a pusher element displacement mechanism that comprises retainer 660. In some implementations, pusher element 110 is movable relative to, and optionally coaxial with, retainer 660.

[0206] According to some exemplary embodiments, the pusher element displacement mechanism further includes a cam connector, e.g., cam connector 662. In some embodiments, retainer 660 is adapted to receive cam connector 662 therein. In some embodiments, cam connector 662 is movable relative to, and optionally coaxially disposed with, retainer 660. In some embodiments, cam connector 662 is adapted to be fixedly attached to proximal end 112 of pusher element 110, e.g., by means of fasteners 664.

[0207] According to some exemplary embodiments, an adjuster, e.g., adjustment element 1002, is at least partially mounted within cam connector 662 and optionally coupled thereto in a cam interface manner by means of pin 674. In some embodiments, adjustment element 1002 has visual scale markings 1016 and 1018 disposed around one or two of the periphery of the sidewalls of adjustment element 1002, e.g., to provide a visual indication as to the desired hole diameter to be formed in the patient's bone. In some embodiments, the center of adjustment element 1002, e.g., adjustment element 670, is fixedly attached to retainer 660 by means of pin 676.

[0208] According to some exemplary embodiments, at least one plunger, e.g., a spring plunger, is disposed on one or both sides of adjustment element 1002, as described, for example, in connection with device 600. In some embodiments, device 1000 includes two plungers, e.g., spring plungers, as shown, for example, in FIG. 19C . In some embodiments, each of the plungers includes a plunger housing, e.g., plunger housings 1004 and 1010, and a spring, e.g., springs 1006 and 1012, respectively. In some embodiments, each of the plunger housings includes a tip disposed in contact with a sidewall of the adjustment element, e.g., adjustment element 1002. In some embodiments, the tip of the housing is shaped and sized to at least partially fit into multiple, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or any greater number of, recesses formed in the sidewall. In some embodiments, each of the plungers is disposed between a cover portion, eg, cover portions 1008 and 1014 , and a sidewall of the adjustment element 1002 .

[0209] According to some exemplary embodiments, the adjustment element, e.g., adjustment element 1002, is a movable, optionally rotatable, adjustment element. In some embodiments, rotation of the adjustment element repositions the plunger housing tip from one recess in the sidewall of adjustment element 1002 to another recess. In some embodiments, a spring in each plunger presses the plunger housing tip against the sidewall of adjustment element 1002, e.g., against the recess in adjustment element 1002. In some embodiments, frictional force exerted by the plunger against the sidewall of the adjustment element, e.g., the recess in the sidewall of adjustment element 1002, holds the adjustment element in a selected rotational orientation. In some embodiments, each selected rotational orientation corresponds to a distinct position of the bone drill, e.g., the shaft 102 or the cutting teeth 130 relative to the longitudinal axis of shaft 102.

[0210] According to some exemplary embodiments, the device, e.g., device 1000, is connectable to a power tool, e.g., a motor, configured to rotate the device 1000, or at least the cutting teeth 130, at up to 2000 rounds per minute (RPM), e.g., 500 RPM, 1000 RPM, 1500 RPM, or any intermediate, lesser, or greater value. In some embodiments, the device includes a bit connector, e.g., bit connector 1020, shaped and sized to be fixedly connected to the retainer 660 at a distal end and adapted to be attached to the power tool at a proximal end. In some embodiments, the proximal end of the bit connector 1020 has a rectangular cross-section, which optionally is complementary to the cross-section of the drilling device connector of the power tool. In some embodiments, as previously described, the power tool is configured to impart rotational motion to the bit connector and, in turn, to the shaft element 102.

[0211] According to some exemplary embodiments, the drilling device 600 is for forming undercut holes of various diameters, for example, by opening the cutting teeth 130 of the drilling device 600 to different radial extents, as described in detail below. In some embodiments, the different radial extents of the cutting teeth are predetermined by alternative positions of the cutting teeth and a selected rotational orientation of the adjustment element 1002. In some embodiments, the adjustment element 1002 is configured to be rotatable by a user in the direction of the longitudinal axis of the shaft and is optionally adapted to cooperate with the cam connector 662 and thereby the pusher element 110, thereby enabling the cutting teeth 130 to be opened to different radial extents, for example, different predetermined radial extents, and thus enabling undercut holes of various diameters to be formed in the patient's bone.

[0212] According to some exemplary embodiments, as shown, for example, in Figures 19D-19F, the drilling device includes a pin, for example, pin 677, for coupling adjustment element 670 to retainer 660, for example, in place of pin 676. In some embodiments, as shown, for example, in Figures 19E and 19F, pin 677 includes one or more interference stops, for example, Christmas tree locks 679 and 681 on opposite ends of pin 677. In some embodiments, the interference stops are spaced apart and configured to secure pin 677 within retainer 660.

[0213] Exemplary Drilling Device with Interchangeable Shafts Reference is now made to Figures 19G and 19H, which illustrate a drilling device having a removable, eg, replaceable, shaft, according to some exemplary embodiments of the present invention.

[0214] According to some exemplary embodiments, a drilling device, e.g., drilling device 680, is provided as a kit and has an interchangeable shaft 682, removably coupled to an adjustment mechanism, and optionally disposed within a cover 684, e.g., a cover formed from cover portions 1008 and 1014 shown in FIG. 19C . In some embodiments, the removable shaft comprises a pusher element and a movable bone drill. In some embodiments, the removable shaft is configured to be removably coupled to the cover and / or adjustment mechanism by at least one reversible mating connector, e.g., a snap connector or at least one screw. In some embodiments, the snap connector is part of a retainer, e.g., retainer 660. Alternatively, the snap connector is part of the cover. In some embodiments, the snap connector is part of cam element 662. Alternatively, the removable shaft 682 is configured to be coupled to the cover 684 via threads 686 located at the proximal end of shaft 682.

[0215] According to some exemplary embodiments, each interchangeable shaft has a different shaft length and / or a different shaft diameter. Additionally or alternatively, each interchangeable shaft has bone drills of different sizes, e.g., different widths, different lengths, different drilling tips, and / or different reamers.

[0216] According to some exemplary embodiments, a user of the drilling device determines a treatment type, e.g., ACL / PCL reconstruction and meniscus root repair, and / or a treatment area, e.g., bone, knee, shoulder, and other joint. In some embodiments, the user selects a removable shaft according to the determined treatment type and / or according to the determined target area.

[0217] According to some exemplary embodiments, the selected shaft and / or bone drill tool is removably coupled to an adjustment mechanism of the bone drill tool, such as a bone drill tool travel adjuster or a bone drill tool tilt adjuster, and / or a cover of the drilling device. Additionally, a pusher mechanism in the shaft is removably coupled to the adjustment mechanism. In some embodiments, a different shaft is selected for pediatric and / or veterinary use. In some embodiments, the selected shaft is configured for single use. In some embodiments, the adjustment mechanism is configured to be reused. In some embodiments, the selected shaft and / or the bone drill tool of the selected shaft are disconnected from the adjustment mechanism, for example, when the bone opening is formed and / or the reaming process is completed. Alternatively, the selected shaft and / or the bone drill tool of the selected shaft are disconnected from the adjustment mechanism, for example, when a different shaft or a different bone drill tool is needed during the reaming process.

[0218] Reference is now made to Figures 20A-20C, which are simplified pictorial views and two different plan views, respectively, of a cam connector, e.g., cam connector 662, forming part of the drilling device 600 of Figures 19A and 19B, according to some exemplary embodiments of the present invention.

[0219] According to some exemplary embodiments, cam connector 662 is optionally an integrally formed element disposed along longitudinal axis 107 .

[0220] In some embodiments, the cam connector 662 is generally U-shaped and has a distal hub portion 700 and, optionally, two proximally extending longitudinal arms 702 extending therefrom, with each arm terminating in a proximally facing edge 704. In some embodiments, the hub portion 700 has a distally facing surface 706 and an opening 708 extending along the longitudinal axis 107. In some embodiments, the hub portion 700 further defines an upwardly facing surface 710 and a downwardly facing surface 712. In some embodiments, a hole 714 extends downwardly from the upwardly facing surface 710 and is disposed generally transverse to the opening 708.

[0221] According to some exemplary embodiments, an opening 720 is formed through each of the longitudinal arms 702 and is positioned generally adjacent the proximally facing edge 704. In some embodiments, the opening 720 extends generally transverse to the longitudinal axis 107.

[0222] 21A-21C, which are simplified pictorial views and two different plan views, respectively, of a retainer, such as retainer 660, forming part of the drilling device 600 of FIGS. 19A and 19B, according to some exemplary embodiments of the present invention.

[0223] According to some exemplary embodiments, retainer 660 is an integrally formed element, optionally positioned along longitudinal axis 107 .

[0224] In some embodiments, the retainer 660 is generally U-shaped and has a distal hub portion 740 and two proximally extending longitudinal arms 742 extending therefrom, with each arm terminating in a proximally facing edge 744. In some embodiments, the hub portion 740 has a distally facing wall 746 and a sleeve 748 extending distally therefrom. In some embodiments, a bore 750 extends through the sleeve 748 and the hub portion 740 and is disposed along the longitudinal axis 107. In some embodiments, the longitudinal arms 742 are arcuate and define an inwardly facing arcuate wall 752 and an outwardly facing arcuate wall 754, respectively. In some embodiments, two elongated tunnels 756 are formed between the longitudinal arms 742.

[0225] According to some exemplary embodiments, an opening 760 is formed through each of the longitudinal arms 742 and is located approximately midway along the longitudinal extent of the arms 742. In some embodiments, the openings 720 extend generally transverse to the longitudinal axis 107.

[0226] Reference is now made to Figures 22A-22C, which are simplified pictorial diagrams and two different plan views, respectively, of a cam element, such as cam element 670, forming part of the drilling device 600 of Figures 19A-19B, according to some exemplary embodiments of the present invention.

[0227] According to some exemplary embodiments, cam element 670 is an integrally formed, disc-shaped element having first and second side walls 780 and a circumferential rim gripping surface 782. In some embodiments, gripping surface 782 is corrugated to facilitate interaction with a user's fingers. In some implementations, as described above, visual scale markings 672 are provided on both side walls 780 of cam element 670, and optionally, markings 672 are located near rim gripping surface 782.

[0228] According to some exemplary embodiments, a central opening 790 is formed in the center of the cam element. In some embodiments, a cam tunnel 800 is formed through the cam element 670 and is preferably disposed at least partially around the central opening 790, optionally forming an eccentric shape relative to the central opening 790. In some embodiments, the cam tunnel 800 includes a first end 801 and a second end 802.

[0229] Additionally, it can be seen in FIGS. 22A and 22B that a plurality of recesses 803 are formed in each of the side walls 780 and are disposed at least partially around and concentric with the central opening 790 .

[0230] Reference is now made to Figures 22D-22F, which illustrate an adjuster, eg, adjustment element, configured to interact with one or more plungers, according to some exemplary embodiments of the present invention.

[0231] According to some exemplary embodiments, the adjuster, e.g., adjustment element 1002, is optionally shaped as a disk having a thin cross-section, as shown, for example, in FIG. 22E. In some embodiments, adjustment element 1002 comprises two opposing sidewalls, e.g., sidewalls 1021 and 1023, and a circumferential rim, optionally having a gripping surface 1017. In some embodiments, adjustment element 1002 comprises an opening 1019, e.g., a central opening, traversing the adjustment element and connecting the two opposing sidewalls 1021 and 1023. In some embodiments, the opening is shaped and sized to allow insertion of a pivot, such as, for example, pin 676 shown in FIG. 19C, to connect adjustment element 1002 to a punching device, e.g., punching device 1000 shown in FIG. 19C.

[0232] According to some exemplary embodiments, adjustment element 1002 comprises a plurality of recesses or sockets on at least one sidewall, e.g., recesses 1015 and 1017 on sidewall 1021 and recesses 1016 and 1018 on sidewall 1023. In some embodiments, the recesses are arranged around the circumference of the sidewall, e.g., in an arcuate or circular pattern. In some embodiments, the recesses are shaped and sized to fit over the tip of a plunger, e.g., placed in contact with the recess.

[0233] According to some exemplary embodiments, the adjustment element 1002 includes one or more human-detectable markings, such as marking 1013, on at least one sidewall of the adjustment element 1002. In some embodiments, the one or more markings are used to mark a particular rotational orientation or position of the adjustment element 1002, e.g., relative to fixed markings on the device. In some embodiments, each particular rotational orientation and marking indicates a distinct position of the bone punch of the device, e.g., cutting teeth 131, relative to the shaft, e.g., shaft 106. In some embodiments, the distinct positions include a closed position of the bone punch, where the bone punch is aligned with the longitudinal axis of the shaft, e.g., during drilling into tissue, and multiple open positions, where the bone punch is angled relative to the shaft, e.g., during reaming, optionally reverse reaming, of an opening in tissue. In some embodiments, each of the one or more human-detectable markings, e.g., marking 1013, indicates a particular width of the tissue opening formed by the perforation device when the cutting teeth are positioned at a distinct position that correlates with the particular human-detectable marking on the adjustment element 1002.

[0234] According to some exemplary embodiments, as shown, for example, in FIG. 22E , adjustment element 1002 comprises a circumferential rim comprising a gripping surface 1017. In some embodiments, gripping surface 1017 is optionally corrugated to facilitate interaction with a user's fingers. In some embodiments, markings, such as marking 1013, are disposed near rim gripping surface 1017.

[0235] Reference is now made to Figures 24F-24I, which are simplified pictorial illustrations, respectively, of covers forming part of the perforation device 1000 of Figure 19C, according to some exemplary embodiments of the present invention.

[0236] According to some exemplary embodiments, a cover, e.g., cover 1029, includes two generally identical cover portions, e.g., cover portions 1008 and 1014, also shown in Figure 19C. In some embodiments, each of cover portions 1008 and 1014 is optionally made of plastic. In some embodiments, the cover portions are adapted to be fastened to one another, for example, by screws, snaps, or any other suitable fastening means.

[0237] In some embodiments, each cover portion of cover 1029 extends generally along longitudinal axis 107 and defines an outer surface, eg, outer surface 1045 , and an inner surface, eg, inner surface 1047 .

[0238] In some embodiments, when the cover portions are fastened together, they form a cover 1029 that defines a proximal end 1049 and a distal end 1051. In some embodiments, an opening 1024 is formed through the proximal end 1049 and extends along the longitudinal axis 107. In some embodiments, an additional opening 1022 is formed through the distal end 1051 and also extends along the longitudinal axis 107. In some embodiments, an aperture 1041 is formed at an intermediate position of each cover portion and, together, is adapted to receive a portion of an adjuster, e.g., the adjustment element 1002. In some embodiments, at least one of the covers includes a visual marking, e.g., a marking 1043 on an exterior surface of at least one of the covers, proximate to or disposed at the opening 1041. In some embodiments, the visual marking is configured to be at least partially aligned with markings on a sidewall of the adjustment element 1002, e.g., markings 1013 to indicate distinct positions of the cutting teeth and / or a particular tissue opening width setting of the punching device.

[0239] According to some exemplary embodiments, one or more inwardly extending flexible protrusions, e.g., protrusions 1042 and 1044, are formed on and extend from an inner surface of at least one of the cover portions. Optionally, the protrusions are snap-fit ​​protrusions. In some embodiments, the protrusions, e.g., protrusions 1042 and 1044, are configured to couple the two cover portions 1014 and 1008 together.

[0240] According to some exemplary embodiments, an inwardly facing socket, e.g., socket 1026, is formed on the interior surface of at least one or both of the cover portions, e.g., cover portions 1008 and 1014. In some embodiments, the socket is shaped and sized to hold a plunger, e.g., a spring plunger. In some embodiments, socket 1026 comprises an inwardly extending protrusion shaped and sized to pass through the inner lumen of the plunger spring, while, optionally, a plunger housing is disposed within socket 1026.

[0241] 24J-24M, which show a spring plunger disposed within a socket formed in a cover portion and interacting with an adjuster, e.g., an adjustment element, according to some exemplary embodiments of the present invention;

[0242] According to some exemplary embodiments, as shown, for example, in FIG. 24K, an adjuster, e.g., adjustment element 1002, is positioned within cover 1029 while at least a portion of adjustment element 1002 extends through opening 1041. In some embodiments, adjustment element 1002 is held securely within cover 1029 by one or more plungers, e.g., one or more spring plungers, pressed against sidewalls of adjustment element 1002.

[0243] According to some exemplary embodiments, a plunger, e.g., a spring plunger comprising a spring 1012 and a plunger housing, is shaped and sized to be disposed within a socket, e.g., a socket 1026 formed on the inner surface of the cover portion. In some embodiments, an inward protrusion, e.g., protrusion 1025, within the socket 1026 is shaped and sized to at least partially extend through a central lumen of the spring 1012. In some embodiments, as shown, for example, in FIGS. 24L and 24M , a plunger housing 1010 having a tip 1032 is disposed around the spring between the spring and the wall of the socket 1026, while the tip 1032 is directed inwardly toward the adjuster, e.g., adjustment element 1002.

[0244] According to some exemplary embodiments, as shown, for example, in Figures 24L and 24M, the spring 1012 is configured to press the housing tip 1032 against a sidewall of the adjusting element 1002, for example, against a recess 1016 formed in the sidewall. In some embodiments, rotation of the adjusting element 1002 pushes the plunger until the housing tip 1032 penetrates the new recess in the sidewall of the adjusting element 1002, allowing rotation of the adjusting element 1002.

[0245] According to some exemplary embodiments, as shown, for example, in FIG. 24L, at least two plungers press against side walls of the adjustment element 1002. In some embodiments, each of the plungers presses a plunger housing tip against both recesses in opposite walls of the adjustment element 1002.

[0246] Reference is now made to Figures 23A-23C, which are simplified pictorial views and three different plan views, respectively, of a bit connector, e.g., bit connector 690, which forms part of the drilling apparatus 600 of Figures 19A and 19B and which is in accordance with some exemplary embodiments of the present invention.

[0247] According to some exemplary embodiments, the bit connector 690 is a unitary element that is disposed along the longitudinal axis 107 .

[0248] In some embodiments, bit connector 690 has a proximal portion 810 of a first diameter adapted to be connected to a power tool, for example, to impart rotational motion from the power tool to drilling device 600. In some embodiments, bit connector 690 further has a generally circular distal portion 812 of a second diameter, optionally substantially larger than the first diameter. In some embodiments, distal portion 812 defines a distal-facing surface 814, a proximal-facing surface 815, and two generally diametrically opposed protrusions 816 extending distally from distal-facing surface 814.

[0249] Reference is now made to Figures 24A-24E, which are a simplified pictorial view, two different plan views, and two cross-sectional views, respectively, of a cover element, e.g., cover element 640, forming part of perforation device 600 of Figures 19A-19B, according to some exemplary embodiments of the present invention (the cross-sectional views are taken along line EE of Figure 24B).

[0250] According to some exemplary embodiments, the cover element 640 includes two generally identical cover portions, optionally made of plastic, adapted to be fastened to one another, for example by screws, snaps, or any other suitable fastening means.

[0251] In some embodiments, each cover portion of cover element 640 extends generally along longitudinal axis 107 and defines an outer surface 830 and an inner surface 832 .

[0252] In some embodiments, when the cover portions are fastened together, they form a cover element 640 that defines a proximal end 834 and a distal end 836. In some embodiments, an opening 838 is formed through the proximal end 834 and extends along the longitudinal axis 107. In some embodiments, an additional opening 840 is formed through the distal end 836 and also extends along the longitudinal axis 107. In some embodiments, an aperture 841 is formed at an intermediate position of each of the cover portions that are adapted together to receive a portion of the adjustment element 670.

[0253] According to some exemplary embodiments, a radially inwardly extending protrusion 842 is formed on each of the cover portions and is optionally located adjacent the proximal end 834. In some embodiments, an additional radially inwardly extending protrusion 844 is formed on each of the cover portions and is spaced generally distally from the protrusion 842.

[0254] Reference is now made to Figures 25A-25C, which are a simplified pictorial illustration and two different plan views, respectively, of a leaf spring, e.g., leaf spring 680, which forms part of the perforation apparatus 600 of Figures 19A and 19B and which is in accordance with some exemplary embodiments of the present invention.

[0255] According to some exemplary embodiments, the leaf spring 680 is an integrally made element and has two retaining portions 860, each having an opening 862 formed thereon adapted to allow attachment of the spring leaf 680 to, for example, the cover element 640.

[0256] In some embodiments, the protruding curved portion 864 is formed between the two retaining portions 860 .

[0257] It should be noted that in some embodiments, the remaining components of the drilling device 600 are generally identical to the components of the drilling device 100, such as the cutting teeth 130, crank 120, pusher element 110, and shaft element 102, as detailed herein.

[0258] Referring now to Figures 26A-26C, which are two different plan and cross-sectional views, respectively, of the drilling device 600 of Figures 19A and 19B shown in a closed operating orientation prior to insertion into a patient's bone, with the cross-sectional views taken along line BB of Figure 26B, in accordance with some exemplary embodiments of the present invention.

[0259] According to some exemplary embodiments, for example as seen in Figures 26A-26C, the drilling device 600 is positioned in a closed operating orientation, while the cutting teeth 130 are positioned in a closed operating orientation.

[0260] According to some exemplary embodiments, cam connector 662 is adapted to be slidably and coaxially mounted within retainer 660. In some embodiments, adjustment element 670 is configured to be partially rotatably positioned within both retainer 660 and cam connector 662, optionally extending between longitudinal arms 742 of cam connector 662 and between longitudinal arms 742 of retainer 660. In some embodiments, retainer 660 is fixedly attached to adjustment element 670, for example, by means of pin 676, such that pin 676 extends along axis 850, which is generally perpendicular to axis 107 and optionally extends through the center of adjustment element 670. In some embodiments, pin 676 extends through opening 760 in retainer 660 and through a central opening 790 in adjustment element 670.

[0261] Additionally, as seen, for example, in FIGS. 26A-26C , cam connector 662 is movably coupled to adjustment element 670, for example, by means of pin 674. In some embodiments, pin 674 extends through opening 720 in cam connector 662 and through cam tunnel 800 in adjustment element 670. In some embodiments, cam connector 662 is further fixedly attached to proximal end 112 of pusher element 110, for example, by means of fastener 664.

[0262] Additionally, as seen, for example, in FIGS. 26A-26C, the protrusion 816 of the bit connector 690 is inserted into an elongated tunnel 756 formed between the longitudinal arms 742 of the retainer 660, such that the bit connector 690 is adapted to transmit rotation from the power tool to the shaft 102.

[0263] According to some embodiments, the pusher element displacement mechanism 650 is generally mounted and enclosed inside the cover element 640, while the rim gripping surface 782 of the adjustment element 670 optionally extends outwardly through an opening 841 formed in each cover element 640 portion. In some embodiments, the longitudinal arm 742 of the retainer 660 is supported by a protrusion 844 of the cover element 640 such that the proximally facing surface 815 engages a distally facing wall of the protrusion 842, thus preventing the bit connector 690 from being displaced in the proximal direction.

[0264] According to some exemplary embodiments, the leaf springs 680 are supported between each of the cover element 640 portions and one of a plurality of recesses 803 formed on each side of the adjustment element 670 and are adapted to hold the adjustment element 670 in a single, distinct position at each given time.

[0265] Alternatively, a plunger such as plunger 164 is supported between each of the cover element 640 portions and one of a plurality of openings formed through adjustment element 670 and is adapted to hold adjustment element 670 in a single, separate position at each given time.

[0266] According to some exemplary embodiments, the shaft element 102 is fixedly connected to the cover element 640, and the proximal end 104 of the shaft element 102 is inserted into the opening 840 of the cover element 640. In some embodiments, the pusher element 110 is partially enclosed within the shaft element 102 and is positioned such that the proximal end 112 of the pusher element extends proximally relative to the proximal end 104 of the shaft element 102.

[0267] According to some exemplary embodiments, as seen, for example, in Figures 26A-26C, the distal end 106 of the shaft and the distal end 114 of the pusher element 110 are connected to a crank 120, for example, by means of a pivot pin 122. In some embodiments, the crank 120 is pivotally connected to the cutting teeth 130, for example, by means of a pivot pin 132. In some implementations, the cutting teeth 130 are pivotally connected to the distal end 106 of the shaft element 102, optionally with two notches 250 and 252 that allow for radial extension of the cutting teeth 130.

[0268] According to some exemplary embodiments, cam connector 662 and pusher element 110 are fixedly attached and therefore optionally movable together. In some embodiments, cam connector 662 and pusher element 110 are slidably movable together axially relative to the center of adjustment element 670. In some embodiments, when adjustment element 670 is rotated by a user, displacement of pin 674 along cam tunnel 800 optionally urges longitudinal displacement of cam connector 662 along longitudinal axis 107. In some implementations, longitudinal displacement of cam connector 662 in turn urges longitudinal displacement of pusher element 110. In some embodiments, displacing the pusher element distally pivots cutting tooth 130, thereby enlarging the diameter of the resulting hole.

[0269] According to some exemplary embodiments, the cutting teeth 130 are the distal-most components of the drilling device 600. In some embodiments, the cutting teeth 130 extend distally relative to the distal end 106 of the shaft element 102. In some embodiments, the cutting teeth 130 function as drilling tips.

[0270] In some embodiments, the adjustment element 670 is rotatable in the direction of the longitudinal axis 107 .

[0271] According to some exemplary embodiments, as seen, for example, in Figures 26A-26C, the drilling device is positioned in a closed operating orientation, in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, and is optionally adapted in this orientation to drill an initial hole in the patient's bone 500, for example, using the drilling end 200, while advancing the drilling device 600 distally through the patient's bone 500.

[0272] According to some exemplary embodiments, rotation of the adjustment element 670, and in turn rotation of the cam connector 662, urges axial displacement of the pusher element 110, which optionally causes radial extension of the cutting teeth 130 relative to the shaft element 102. In some embodiments, the degree of radial extension of the cutting teeth is defined by the degree of rotation of the adjustment element 670.

[0273] In some implementations, leaf spring 680 is biased radially inward to seat within one of multiple recesses 803 in adjustment element 670, thus optionally holding adjustment element 670 in a single, distinct rotational orientation, and thus, in turn, holding cutting teeth 130 that extend to a distinct radial extent. In some embodiments, one or more other types of biasing mechanisms are used to hold adjustment element 670 in position.

[0274] According to some exemplary embodiments, adjustment element 670 is freely rotatable relative to other components of drilling apparatus 600. In some embodiments, once adjustment element 670 is rotated relative to cam connector 662, pin 674 coupling adjustment element 670 and cam connector 662 is displaced along cam tunnel 800, thus optionally biasing axial displacement of cam connector 662.

[0275] According to some exemplary embodiments, with each incremental rotation of the adjustment element 670 by the user, the cam connector 662 is displaced axially along the axis 107, thus optionally displacing the pusher element 110 and defining the range of radial extension of the cutting teeth 130 relative to the outer periphery of the shaft element 102.

[0276] According to some exemplary embodiments, axial rotation of adjustment element 670 displaces cam connector 662 relative to retainer 660. In some embodiments, axial displacement of cam connector 662 in turn prompts axial displacement of pusher element 110, which optionally causes corresponding pivoting of crank 120 and, in turn, cutting teeth 130, which, for example, defines the resulting diameter of the hole in patient's bone 500 upon proximal displacement of drilling device 600 within patient's bone 500.

[0277] According to some exemplary embodiments, as seen in FIGS. 26A-26C , for example, in the closed operating orientation, distal hub 700 of cam connector 662 is spaced proximally from distal hub portion 740 of retainer 600, thus disposing pusher element 110 in its distal position, with cutting teeth 130 in this position closed and not extending from the outer periphery of shaft element 102. In some embodiments, this position is adapted to advance drilling device 600 distally to form an initial hole in patient's bone 500. In some embodiments, as seen in FIG. 26C , for example, pin 674 is disposed in first end 801 of cam tunnel 800 of adjustment element 670 in this closed operating orientation, thus positioning the cam connector in its proximal operating orientation.

[0278] According to some exemplary embodiments, alignment between marks that may be formed on the cover element 640 with the scale markings 672 on the adjustment element 670 indicates to the user the currently adjusted diameter.

[0279] 27A-27C, which are two different plan and cross-sectional views, respectively, of a drilling device, e.g., drilling device 600 of FIGS. 19A and 19B, shown in a closed operating orientation following forward drilling into a patient's bone 500, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line BB of FIG. 27B.

[0280] According to some exemplary embodiments, as seen, for example, in Figures 27A-27C, the punching device 600 is positioned in a closed operating orientation, while the cutting teeth 130 are positioned in a closed operating orientation.

[0281] According to some exemplary embodiments, as seen, for example, in Figures 26A-26C, the drilling device is positioned in a closed operating orientation, in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, and in this orientation an initial hole 510 of a first diameter is formed in the patient's bone 500, for example using the drilling end 200, while optionally advancing the drilling device 600 distally through the patient's bone 500.

[0282] In some embodiments, rotation of the adjustment element 670, and in turn rotation of the cam connector 662, urges axial displacement of the pusher element 110, thereby causing radial extension of the cutting teeth 130 relative to the shaft element 102. In some embodiments, the degree of radial extension of the cutting teeth is defined by the degree of rotation of the adjustment element 670. In some embodiments, in this operating orientation, the diameter of the initial hole 510 is set in the range of 1.5 mm to 5.5 mm, e.g., 3 mm, 3.5 mm, 4 mm, 4.5 mm, or any intermediate, smaller, or larger diameter or range of diameters. In some embodiments, any other suitable diameter for the initial hole can be formed using the drilling device 600 in the closed operating orientation.

[0283] According to some exemplary embodiments, alignment between marks that may be formed on the cover element 640 with scale markings 672 on the adjustment element 670 indicates to the user the currently adjusted diameter, as seen, for example, in Figure 27A. In some embodiments, all other spatial relationships between the different components of the drilling device 600 remain substantially the same as those described, for example, with reference to Figures 26A-26C.

[0284] Referring now to Figures 28A-28C, Figures 28A-28C are two different plan views and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, for example, the drilling device 600 of Figures 19A and 19B shown in a first partially open operating orientation inserted into a patient's bone 500, the cross-sectional view being along line BB of Figure 28B.

[0285] According to some exemplary embodiments, as seen, for example, in FIGS. 28A-28C , the drilling device 600 is in a first partially open operating orientation, in which the cutting teeth 130 extend slightly radially from the outer surface of the shaft element 102, and in this orientation is adapted to ream an undercut hole having a diameter of 4 to 8 mm, e.g., 5 mm, 5.5 mm, 6 mm, or any intermediate, smaller, or larger diameter or diameter range, in the patient's bone 500, using, for example, the reaming end 202, while optionally advancing the drilling device 600 rearward in a proximal direction through the patient's bone 500.

[0286] According to some exemplary embodiments, rotation of the adjustment element 670, and in turn rotation of the cam connector 662, axially displaces and pivots the crank 120, which in turn biases the axial displacement of the pusher element 110, causing radial extension of the cutting teeth 130 relative to the shaft element 102, the range of radial extension of the cutting teeth being defined by the range of rotation of the adjustment element 670. In some embodiments, in this particular operating orientation, the diameter of the undercut hole 520 is set in the range of 4 to 8 mm, e.g., 5 mm, 5.5 mm, 6 mm, or any intermediate, smaller or larger diameter or range of diameters. In some embodiments, any other suitable diameter for the undercut hole can be formed using the drilling device 600 in the first partially open operating orientation.

[0287] According to some exemplary embodiments, as seen, for example, in FIG. 28A, alignment between marks that may be formed on the cover element 640 with scale markings 672 on the adjustment element 670 indicates to the user the currently adjusted diameter.

[0288] According to some exemplary embodiments, as seen in FIG. 28A , for example, distal hub portion 700 of cam connector 662 is spaced proximally from distal hub portion 740 of retainer 660. In some embodiments, as seen in FIG. 28C , for example, pin 674 is slightly displaced along cam tunnel 800 away from its first end 801. Optionally, due to a fixed connection between pin 674 and cam connector 662, following displacement of pin 674 along cam tunnel 800, cam connector 662 is displaced distally, thereby, for example, biasing distal displacement of pusher element 110 and thus biasing the opening of cutting teeth 130 to a diameter set by the user.

[0289] According to some exemplary embodiments, adjustment element 670 is held in a particular orientation by means of leaf spring 680, which optionally seats in one of recesses 803 of adjustment element 670 and thus optionally prevents its inadvertent rotation.

[0290] According to some exemplary embodiments, upon distal displacement of the pusher element 110, the crank 120 is pivoted about the pin 122, and the cutting tooth 130 is then pivoted about its pivot axis, which is the pivot pin 134. In some embodiments, as the cutting tooth 130 pivots about the pivot pin 134, the reaming end 202 of the cutting tooth 130 engages the patient's bone 500, thus widening the diameter of the initial hole 510 to the undercut hole 520 during proximal advancement of the drilling device 100. In some embodiments, the undercut hole 520 has a diameter of 6 mm in this particular example.

[0291] According to some exemplary embodiments, the pivot 134 is positioned closer to the drilling end 200 than the reaming end 202, and therefore, optionally, the reaming end of the cutting tooth is longer than the drilling end 200, thereby enabling effective engagement of the reaming end 202 with the initial hole 510.

[0292] According to some exemplary embodiments, pivoting the cutting tooth 130 about the pivot axis 134 causes the cutting tooth 130 to extend radially from the outer periphery of the shaft element 102. In some embodiments, the piercing end 200 of the cutting tooth 130 extends radially through a notch 250 in the shaft element 102, and the reaming end 202 simultaneously extends radially through a notch 252 in the shaft element 102.

[0293] In some embodiments, the fact that cutting teeth 130 are the most distal component of drilling device 600 allows for precise formation of undercut holes 520, for example.

[0294] In some embodiments, all other spatial relationships between the different components of the punching device 600 remain substantially the same as those described, for example, with reference to Figures 27A-27C.

[0295] Referring now to Figures 29A-29C, Figures 29A-29C are two different plan views and cross-sectional views, respectively, of a drilling device, e.g., drilling device 600 of Figures 19A and 19B, shown in a second, partially open operating orientation inserted into a patient's bone 500, according to some exemplary embodiments of the present invention, the cross-sectional view being taken along line BB of Figure 29B.

[0296] According to some exemplary embodiments, as seen, for example, in FIGS. 29A-29C , the drilling device 600 is in a second partially open operating orientation, in which the cutting teeth 130 extend more radially from the outer surface of the shaft element 102, and is optionally adapted in this orientation to ream an undercut hole having a diameter or diameter range of 8 to 10 mm, e.g., 8.5 mm, 9 mm, 9.5 mm, or any intermediate, smaller, or larger diameter, within the patient's bone 500 using the reaming end 202 while advancing the drilling device 600 rearwardly in a proximal direction through the patient's bone 500.

[0297] According to some exemplary embodiments, rotation of adjustment element 670, and in turn rotation of cam connector 662, optionally urges axial displacement of pusher element 110, thereby causing radial extension of cutting teeth 130 relative to shaft element 102. In some embodiments, the degree of radial extension of the cutting teeth is defined by the degree of rotation of adjustment element 670. In some embodiments, in this particular operating orientation, the diameter of undercut hole 530 is set to 9 mm. In some embodiments, any other suitable diameter for undercut hole can be formed using drilling apparatus 600 in the second partially open operating orientation.

[0298] In some embodiments, as seen, for example, in FIG. 29A, a match between marks that may be formed on the cover element 640 with scale markings 672 on the adjustment element 670 indicates to the user the currently adjusted diameter.

[0299] In some embodiments, as seen, for example, in FIG. 29A, the distal hub portion 700 of the cam connector 662 is spaced less proximally from the distal hub portion 740 of the retainer 660 compared to FIG. 28A.

[0300] According to some exemplary embodiments, as seen in, for example, FIG. 29C , pin 674 is further displaced along cam tunnel 800 away from its first end 801, as compared to FIG. 28C . Optionally, due to a fixed connection between pin 674 and cam connector 662, following further displacement of pin 674 along cam tunnel 800, cam connector 662 is further displaced distally, thereby optionally urging further distal displacement of pusher element 110, axially displacing and pivoting crank 120, and thus further opening cutting tooth 130 to a diameter set by the user.

[0301] According to some exemplary embodiments, adjustment element 670 is held in a particular orientation by means of leaf spring 680, which optionally seats in one of recesses 803 of adjustment element 670, thus optionally preventing its inadvertent rotation.

[0302] According to some exemplary embodiments, upon distal displacement of the pusher element 110, the crank 120 is pivoted about the pin 122 and the cutting tooth 130 is pivoted about a pivot axis, which is the pivot pin 134. In some embodiments, as the cutting tooth 130 pivots about the pivot pin 134, the reaming end 202 of the cutting tooth 130 engages the patient's bone 500, thus further widening the diameter of the initial hole 510 to the undercut hole 530 during proximal advancement of the drilling device 100. In some embodiments, the undercut hole 530 has a diameter in the range of 8-10 mm, e.g., 8 mm, 8.5 mm, 9 mm, or any intermediate, smaller, or larger diameter or range. In some embodiments, the pivot axis 134 is positioned closer to the drilling end 200 than the reaming end 202, so that, for example, the reaming end of the cutting tooth is longer than the drilling end 200, thereby optionally allowing effective engagement of the reaming end 202 with the initial hole 510.

[0303] According to some exemplary embodiments, pivoting the cutting tooth 130 about the pivot axis 134 causes the cutting tooth 130 to extend radially from the outer periphery of the shaft element 102. In some embodiments, the piercing end 200 of the cutting tooth 130 extends radially through a notch 250 in the shaft element 102, and the reaming end 202 simultaneously extends radially through a notch 252 in the shaft element 102.

[0304] In some embodiments, the cutting teeth 130 are the most distal component of the drilling device 100 , optionally allowing for precise formation of the undercut holes 530 .

[0305] In some embodiments, all other spatial relationships between the different components of the punching device 600 remain substantially the same as those described, for example, with reference to Figures 28A-28C.

[0306] Referring now to Figures 30A-30C, Figures 30A-30C are two different plan views and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, for example, the drilling device 600 of Figures 19A and 19B shown in a fully open operating orientation inserted into a patient's bone 500, the cross-sectional view being along line BB of Figure 30B.

[0307] According to some exemplary embodiments, as seen, for example, in FIGS. 30A-30C , the drilling device 600 is in a fully open operating orientation, where the cutting teeth 130 optionally extend further radially from the outer surface of the shaft element 102, and in this orientation is adapted to ream an undercut hole having a diameter of 10-14 mm, e.g., 11 mm, 12 mm, 12.5, or any intermediate, smaller, or larger diameter or diameter range, within the patient's bone 500, optionally using the reaming end 202 while advancing the drilling device 600 proximally backward through the patient's bone 500.

[0308] According to some exemplary embodiments, rotation of the adjustment element 670, and subsequently rotation of the cam connector 662, prompts axial displacement of the pusher element 110, axially displacing and pivoting the crank 120, thereby, optionally, causing radial extension of the cutting teeth 130 relative to the shaft element 102. In some embodiments, the degree of radial extension of the cutting teeth is defined by the degree of rotation of the adjustment element 670. In some embodiments, in this particular operating orientation, the diameter of the undercut holes 540 is set to 12 mm. Note that in some embodiments, any other suitable diameter for the undercut holes can be formed using the drilling device 600 in a fully open operating orientation. In some embodiments, in this fully open operating orientation, the cutting teeth 130 extend transversely to the longitudinal axis 107.

[0309] In some embodiments, as seen, for example, in FIG. 30A, alignment between marks that may be formed on the cover element 640 with scale markings 672 on the adjustment element 670 indicates to the user the currently adjusted diameter.

[0310] In some embodiments, as seen, for example, in FIG. 30A, the distal hub portion 700 of the cam connector 662 is displaced further distally, where it is positioned adjacent to the distal hub portion 740 of the retainer 660, as compared, for example, to FIG. 29A.

[0311] 30C , as compared to, for example, FIG. 29C , pin 674 is further displaced along cam tunnel 800 away from its first end 801, where it is now positioned adjacent second end 802. Optionally, due to a fixed connection between pin 674 and cam connector 662, following further displacement of pin 674 along cam tunnel 800, cam connector 662 is further displaced distally, thereby optionally urging further distal displacement of pusher element 110 and axially displacing and pivoting crank 120, and thus, optionally, further opening cutting tooth 130 to a diameter set by the user.

[0312] In some embodiments, the adjustment element 670 is held in a particular orientation by means of a leaf spring 680 that optionally seats within one of the recesses 803 of the adjustment element 670, thus preventing its inadvertent rotation.

[0313] According to some exemplary embodiments, upon distal displacement of pusher element 110, crank 120 is pivoted about pin 122, and cutting tooth 130 is then pivoted about its pivot axis, which is pivot pin 134. In some embodiments, pivoting of cutting tooth 130 about pivot pin 134 causes reaming end 202 of cutting tooth 130 to engage patient's bone 500, thus optionally widening the diameter of initial hole 510 to undercut hole 540 during proximal advancement of drilling device 600. Undercut hole 540 has a diameter of 12 mm in this particular example and in some embodiments of the present invention.

[0314] In some embodiments, the pivot 134 is positioned closer to the drilling end 200 than the reaming end 202, and thus optionally the reaming end of the cutting tooth is longer than the drilling end 200, thereby, for example, enabling effective engagement of the reaming end 202 with the initial hole 510.

[0315] In some embodiments, pivoting the cutting tooth 130 about the pivot axis 134 causes the cutting tooth 130 to extend radially from the outer periphery of the shaft element 102. In some embodiments, the drilling end 200 of the cutting tooth 130 extends radially through a notch 250 in the shaft element 102, and the reaming end 202 simultaneously extends radially through a notch 252 in the shaft element 102.

[0316] In some embodiments, cutting teeth 130 are the distal-most components of drilling device 100, allowing for precise formation of undercut holes 540, for example.

[0317] In some embodiments, all other spatial relationships between the different components of the punching device 600 remain substantially the same as those described, for example, with reference to Figures 29A-29C.

[0318] Referring now to Figures 31A-31C, Figures 31A-31C are two different plan views and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, for example, the drilling device 600 of Figures 19A and 19B shown in a closed operating orientation prior to removal from the patient's bone 500, with the cross-sectional views taken along line BB of Figure 31B.

[0319] According to some exemplary embodiments, as seen in Figures 31A-31C, for example, the drilling device 600 is in a fully closed operational orientation in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102, adapted to withdraw the drilling device 600 from the patient's bone 500 while retracting the drilling device 600 proximally. Figures 31A-31C show the drilling device 600 prior to retraction from the patient's bone 500.

[0320] In some embodiments, rotation of the adjustment element 670 and subsequent rotation of the cam connector 662 urges axial displacement of the pusher element 110 proximally, which optionally causes radial retraction of the cutting teeth 130 relative to the shaft element 102.

[0321] In some embodiments, as seen, for example, in FIG. 30A, a match between markings that may be formed on the cover element 640 with a scale 672 on the adjustment element 670 indicates to the user the currently adjusted diameter.

[0322] In some embodiments, as seen, for example, in FIG. 31C, the pin 674 is positioned adjacent to the first end 801 of the cam tunnel 800, thereby optionally urging the pusher element 110 to move proximally, thus closing the cutting teeth 130.

[0323] In some embodiments, the adjustment element 670 is held in a particular orientation by means of a leaf spring 680 that optionally seats within one of the recesses 803 of the adjustment element 670, thus preventing its inadvertent rotation.

[0324] Referring now to Figures 32A-32C, Figures 32A-32C are two different plan views and cross-sectional views, respectively, of a drilling device according to some exemplary embodiments of the present invention, for example, drilling device 600 of Figures 19A and 19B shown in a closed operating orientation after removal from the patient's bone 500, with the cross-sectional views taken along line BB of Figure 32B.

[0325] According to some exemplary embodiments, as seen in, for example, Figures 32A-32C, the drilling device 600 is in a fully closed operating orientation in which the cutting teeth 130 do not extend radially from the outer surface of the shaft element 102. Figures 32A-32C show the drilling device 100 after retraction from the patient's bone 500, while the resulting initial hole 510 and undercut holes 520 / 530 / 540 are clearly seen as formed in the patient's bone 500.

[0326] It will be appreciated by those skilled in the art that the present invention is not limited by what has been particularly shown and described above, but rather the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not present in the prior art.

[0327] As used herein, the term "about" in relation to amounts and values ​​means ±20%.

[0328] The terms "comprises," "comprising," "includes," "including," "has," "having," and combinations thereof, mean "including but not limited to."

[0329] The term "consisting of" means "including and limited to."

[0330] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0331] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the terms "compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof. Throughout this application, embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, recitation of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0332] Whenever a numerical range is given herein (e.g., "10-15," "10to15," or any pair of numbers connected by these or another such range designation), it is meant to include any number (fractional or integer) within the stated range limit, inclusive of the range limit, unless the context clearly dictates otherwise. The terms "range / ranging / ranging between" a first stated number and a second stated number, "range / ranging from" a first stated number, "to," "up to," "until," or "through" (or other "range-indicating"-like terminology) a second stated number, are used interchangeably herein and are meant to include the first and second stated numbers, and all decimals and integers therebetween.

[0333] Unless otherwise indicated, numbers used herein, and any numerical ranges based thereon, are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0334] As used herein, the term "treating" includes eliminating, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0335] It will be understood that particular features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as appropriate, with any other described embodiment of the invention. Particular features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment is inoperable without those elements.

[0336] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0337] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. To the extent section headings are used, they should not be construed as necessarily limiting.

[0338] Additionally, any priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. an elongate shaft having a longitudinal axis, a distal end, and a proximal end, the elongate shaft having a side-to-side intersecting opening therethrough; a movable bone drill having a distal drilling tip and at least one proximal reamer, the movable bone drill being movably coupled to a distal end of the elongate shaft; a rotatable bone drill adjuster adjuster attached to the proximal end of the elongate shaft and to the movable bone drill, the rotatable bone drill adjuster configured to move the movable bone drill between a drilling state in which the drilling tip is disposed in contact with bone tissue and a plurality of reaming states in which the at least one proximal reamer is disposed in contact with bone tissue; the movable bone tunnel drill is at least partially within the opening, and in the drilling state, the movable bone tunnel drill closes the opening by a first percentage, and in each of the plurality of reaming states, the movable bone tunnel drill closes the opening by a second percentage, the second percentage being less than the first percentage.

2. The apparatus of claim 1 , wherein the movable bone drill is configured to rotate about the longitudinal axis.

3. The device of claim 1 or 2, wherein in the drilling state, the movable bone punch is positioned proximally relative to the distal end of the longitudinal axis.

4. 4. The apparatus of claim 1, wherein in each of the plurality of reaming states, the movable bone drill has a preselected angle of inclination relative to the longitudinal axis, and the movable bone drill is in a predetermined reaming state in which the movable bone drill is configured to ream.

5. 5. The device of claim 1, wherein the opening is sized and shaped to allow bone fragments resulting from the movable bone tunnel drill in the drilling state and / or one of the plurality of reaming states to be moved through the opening from one side of the longitudinal axis to the opposite side of the longitudinal axis during reaming.

6. The device of claim 5 , wherein the opening is sized and shaped to allow bone fragments to be displaced through the opening as the device is advanced axially into bone tissue.

7. The apparatus of any one of claims 1 to 6, wherein the movable bone tunneling tool has a closed state in which the movable bone tunneling tool is positioned within the opening.

8. The apparatus of claim 7 , wherein the bone punch is configured to be in the closed state during the drilling state.

9. The movable bone tunneling tool includes: removing bone fragments from the opening caused by the movable bone drill tool in the drilling state and / or one of the plurality of reaming states; and pressing the proximal end of the movable bone drill against the longitudinal axis; The device according to any one of claims 1 to 8, wherein the device is tiltable into the opening by at least one of:

10. The device of any one of claims 1 to 9, wherein in the drilling state, the movable bone punch closes at least 90% of the opening with the elongate shaft.

11. The apparatus of any one of claims 1 to 10, wherein in each of the plurality of reaming conditions, the movable bone drill defines a window of at least 10% of the opening.

12. The apparatus of any one of claims 1 to 11, wherein the movable bone drill is a movable cutting tooth.

13. The device of any one of claims 1 to 12, wherein the rotatable bone drill adjuster is configured to adjust the angle of inclination of the movable bone drill relative to the elongate shaft.

14. The device of any one of claims 1 to 13, wherein the opening is formed by at least two opposing lateral notches in the distal end of the elongate shaft.

15. The apparatus of any preceding claim, wherein the rotatable bone drill adjuster includes markings that indicate an open state of the movable bone drill relative to the opening.

16. 16. The device of claim 15, wherein the markings are configured to convey a human-detectable indication regarding at least one of an open state, a lateral extension, a radial extension, and an inclination angle of the movable bone drill.

17. A method for manufacturing a bone removal device according to any one of claims 1 to 16, comprising the steps of: The bone removal device comprises: an elongate shaft having a longitudinal axis, a distal end, and a proximal end, the elongate shaft having a pair of opposed transverse notches forming a side-to-side intersecting opening therethrough; a movable bone drill movably coupled to a distal end of the elongate shaft; the movable bone drill tool is configured to move between a drilling state in which the drilling tip is configured to be placed in contact with bone tissue and a plurality of reaming states in which the at least one proximal reamer is in a predetermined reaming position in which the movable bone drill tool is configured to be placed in contact with bone tissue; the movable bone tunnel drill is at least partially within the opening, and in the drilling state, the movable bone tunnel drill closes a first percentage of the opening, and in each of the plurality of reaming states, the movable bone tunnel drill closes a second percentage of the opening, the second percentage being less than the first percentage; The bone removal device further comprises: a rotatable bone drill adjuster on a proximal end of the elongate shaft and attached to the movable bone drill; The method comprises: providing an elongate shaft having a movable bone tunnel drill movably coupled to a distal end thereof and the rotatable bone tunnel drill adjuster, the rotatable bone tunnel drill adjuster configured to adjust an angle of inclination of the movable bone tunnel drill relative to the elongate shaft; aligning the movable bone drill and the rotatable bone drill adjuster in alignment; operatively coupling the movable bone drill to the rotatable bone drill adjuster in the aligned position.

18. 18. The method of claim 17, wherein the movable bone drill is configured to rotate about the longitudinal axis.

19. 19. The method of claim 17 or 18, wherein in each of the plurality of reaming conditions, the movable bone drill is at a preselected angle of inclination relative to the longitudinal axis.

20. 20. The method of any one of claims 17 to 19, wherein the aligning comprises placing the movable bone drill at one of the predetermined reaming positions, and positioning the rotatable bone drill adjuster at a selected stop while holding the movable bone drill at the one of the predetermined reaming positions.

21. 21. The method of any one of claims 17 to 20, wherein said operatively coupling comprises locking a screw to couple said movable bone drill to said rotatable bone drill adjuster.

22. A method for assembling a bone removal device according to any one of claims 1 to 16, comprising the steps of: The bone removal device comprises: an elongate shaft having a longitudinal axis, a distal end, and a proximal end; a movable bone drill having a distal drilling tip and at least one proximal reamer, the movable bone drill being movably coupled to a distal end of the elongate shaft; a rotatable bone drill adjuster on the proximal end of the elongate shaft and attached to the movable bone drill; The method comprises: determining a treatment type and / or treatment area; selecting the elongate shaft having the movable bone drill coupled thereto according to the determined treatment type and / or the determined treatment area; selecting a rotatable bone drill adjuster; and removably coupling the elongate shaft to the bone drill travel adjuster.

23. 23. The method of claim 22, wherein the movably coupling comprises removably coupling a pusher element that controls the tilt angle of the movable bone drill to the rotatable bone drill adjuster.

24. 24. The method of claim 22 or 23, comprising disconnecting the elongate shaft from the rotatable bone punch adjuster.

25. 1. A bone removal kit comprising a device, The device comprises: an elongate shaft having a longitudinal axis, a distal end, and a proximal end, the elongate shaft having a pair of opposed transverse notches forming a side-to-side intersecting opening therethrough; a movable bone tunnel drill having a distal drilling tip and at least one proximal reamer, the movable bone tunnel drill coupled to a distal end of the elongate shaft; an adjustment mechanism including a bone drill travel adjuster on a proximal end of the elongate shaft and attached to the movable bone drill, the bone drill travel adjuster configured to adjust travel of the movable bone drill relative to the elongate shaft between a drilling state in which the drilling tip is positioned in contact with bone tissue and a multiple reaming state in which the at least one proximal reamer is positioned in contact with bone tissue; the movable bone drill is removably coupled to one of the elongate shaft and the adjustment mechanism; the movable bone tunnel drill is at least partially within the opening, and in the drilling state, the movable bone tunnel drill closes the opening by a first percentage, and in each of the plurality of reaming states, the movable bone tunnel drill closes the opening by a second percentage, the second percentage being less than the first percentage.

26. 26. The kit of claim 25, wherein the movable bone drill is configured to rotate about the longitudinal axis.

27. 27. The kit of claim 25 or 26, wherein the elongate shaft includes a pusher element coupled to the movable bone drill, the pusher element configured to be removably coupled to the adjustment mechanism.

28. 28. The kit of any one of claims 25 to 27, comprising at least one reversible coupling connector coupled to the elongate shaft and / or the bone drill travel adjuster, wherein the proximal end of the elongate shaft is removably coupled to the bone drill travel adjuster by the at least one reversible coupling connector.

29. 30. The kit of claim 28, wherein the at least one reversible mating connector comprises a snap connector.

Images