Bone material removal device

Abstract

A bone material removal device is provided. [Solution] The bone material removal device 300 comprises a cannula, a drilling tip 314, and a hole widening element 304 having a bone-chisel portion that slides axially relative to the cannula and extends circumferentially, and axial movement of the hole widening element relative to the cannula causes the chisel portion to extend radially and circumferentially beyond the surface of the cannula and chisel bone from the wall of the hole.

Description

[Technical Field]

[0001] The present invention, in some embodiments thereof, relates to bone removal devices, and more particularly, but not exclusively, to devices for varying the effective diameter of a hole. [Background technology]

[0002] Various orthopedic reconstructive procedures, particularly ligament or tendon reconstructive procedures such as anterior cruciate ligament (ACL) reconstruction, require the implantation of a surgical tissue graft (e.g., a ligament graft) that is inserted into bone to replace damaged tissue, which is removed from the bone before the graft is inserted through a hole created by drilling.

[0003] In some ligament or tendon reconstruction procedures, it is useful to drill an undercut deep into the surface of the bone to accommodate an anchor for the graft.

[0004] Some common devices for creating undercuts in bone employ a tool with a single scraping edge that circumferentially scrapes and widens a portion of the wall of the drill hole.

[0005] Such techniques utilize high friction between the blade and the bone, which not only makes them laborious to operate, but also creates debris, primarily consisting of small particles, that can interfere with anchor placement, making removal a challenge.

[0006] The various drilling tools used to form undercuts along drilled holes in bone can be expensive to manufacture and prone to wear and failure over time because they rely on moving components such as hinges, springs, etc. Additionally, operation of such tools can be somewhat cumbersome and require multiple operational steps to function. Summary of the Invention [Means for solving the problem]

[0007] According to an aspect of some embodiments of the present invention there is provided a bone material removal device comprising: a forward tip; a cannula; and a hole widening element having a bone chiseling portion, the hole widening element operating to slide axially relative to the cannula and extend at least partially circumferentially, wherein overall axial movement of the hole widening element relative to the cannula causes radially extending, advancing radially extending chiseling portions to extend the hole widening element from a closed, retracted position where the bone chiseling portion is retracted within a diameter of the cannula or an imaginary axial extension thereof, to an open, extended position where the bone chiseling portion extends circumferentially beyond the diameter of a surface of the cannula or an imaginary axial extension thereof to chisel bone from a wall of the hole.

[0008] In accordance with an aspect of some embodiments of the present invention, at least one resilient arm is provided having at least one chiseling feature at an end thereof, such that axial movement causes the at least one arm to engage a fixed surface that geometrically interferes with the axial movement and flexes the arm to deflect the chiseling feature that extends radially and circumferentially beyond the surface of the cannula and chisels bone from the wall of the hole.

[0009] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device having a hole widening element that is a single elastic member, the hole widening element having at least one engraved portion at a distal end and at least two distal extension arms separated by a longitudinal recess having a proximal closed end and a distal open end.

[0010] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device having a hole widening element that is a single resilient member having one or more arms defining a widening portion at a distal end of the hole widening element, the widening portion having a carving portion and defining a distally facing inner proximal tapered surface on the distal surface of the carving portion.

[0011] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a cutting portion including at least one cutting blade.

[0012] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a cutting portion with at least two first and second cutting blades angled relative to one another and joined at least at one end.

[0013] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device having a first chisel blade that cuts a major portion of a bone fragment to form a first surface of the fragment and a second chisel blade that cuts a second adjacent surface of the fragment to remove the bone fragment.

[0014] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device having a hole widening element having at least one chiseling portion at a distal end and comprising at least two distally extending arms separated by a longitudinal recess, wherein the first chiseling blade, the second chiseling blade, and the angle therebetween define a rake angle that provides an upwardly facing surface against which removal residue rises and collects in the recess.

[0015] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device having a cutting portion bounded on one side by a first cutting edge and further comprising a radially positioned curved surface forming an end relief or clearance curve that prevents friction of the cutting portion against the bone.

[0016] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a chiseled portion joined to an outer surface of an arm by a generally proximal inwardly tapered surface.

[0017] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having prongs.

[0018] According to one aspect of some embodiments of the present invention, a bone material removal device is provided in which axial movement of the hole widening element engages at least one resilient arm with a protrusion that geometrically interferes with the axial movement of the hole widening element, and the arm bends to extend and advance radially and circumferentially beyond the surface of the cannula and deflect a cutting portion that chips bone from the wall of the hole.

[0019] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device having a protrusion extending proximally from a proximal-facing surface between the forward tip and the hole widening element, and at least one resilient arm further having a distal-facing inclined surface on the distal surface of its cutting portion, wherein axial movement of the hole widening element engages the protrusion, which geometrically interferes with the axial movement, with the inclined surface of the cutting portion, and bending of the arm causes radial deflection of the cutting portion.

[0020] Of course, in this and other embodiments, one or both of the two mating surfaces may be angled.

[0021] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device wherein at least one resilient arm has centrally facing surfaces with protrusions adjacent the centrally facing surfaces such that axial movement of the hole widening element relative to the cannula biases the centrally facing surfaces against the protrusions that geometrically interfere with the axial movement of the arms, and the arms bend and deflect, causing the cutting portion to extend radially beyond the surface of the cannula and scrape bone from the wall of the hole.

[0022] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein the resilient arm further comprises a non-carving portion that extends distally beyond at least one carving portion and abuts proximally, terminating in an inclined surface, and wherein axial movement of the hole widening element engages the inclined surface of the non-carving portion with a protrusion that geometrically interferes with the axial movement, and the arm bends, causing the carving portion to extend radially beyond the surface of the cannula and carve bone from the wall of the hole.

[0023] According to an aspect of some embodiments of the present invention there is provided a bone material removal device comprising a chiseled portion that extends radially due to a bending force applied to a single face of at least one arm of a spreader element.

[0024] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device having a cannula with a hollow portion and at least one through opening in its wall, with a bone chiseling portion extending circumferentially through the at least one opening.

[0025] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein the carving portion comprises at least one proximal inward tapered surface, the hole widening element is housed in the cannula in a stressed state, and axial movement urges the ramp surface upward against a distally facing shoulder of the at least one opening, disengaging the ramp surface and causing radial extension of the at least one carving portion.

[0026] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device wherein the radial extension of at least one engraving portion is caused by the tendency of the stressed hole widening element to return to its original resting state.

[0027] According to an aspect of some embodiments of the present invention there is provided a bone material removal device further comprising a counter support for supporting the carving portion in an extended position.

[0028] According to an aspect of some embodiments of the present invention there is provided a bone material removal device further comprising a counter support that resists radial forces directed towards the center and prevents the cutting portion from backing out into the cannula.

[0029] According to an aspect of some embodiments of the present invention there is provided a bone material removal device further comprising a protrusion acting as a counter support.

[0030] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein at least one arm, when fully deflected, is generally parallel to a longitudinal axis of the bone material removal device and a blade supported by a counter support.

[0031] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, the tip being a bone drilling tip.

[0032] According to an aspect of some embodiments of the present invention there is provided a method of removing bone material from a bone, the method comprising the steps of: Axial moving a hole widening element having at least one resilient arm and at least one engraved portion at an end thereof; biasing a resilient arm against a surface that geometrically interferes with the axial movement of the hole widening element to apply a radial force to the arm; bending the arm and radially deflecting the engraving portion to an extended circumferential position; scraping bone from the wall of the hole to form an undercut in the bone; A method is provided, comprising:

[0033] In accordance with an aspect of some embodiments of the present invention, there is provided a method for converting an axial force applied to a surface by axial movement of a hole widening element into a radial force to radially deflect a cutting portion to an extended circumferential position.

[0034] According to an aspect of some embodiments of the present invention there is provided a method of removing bone material from a bone, the method comprising the steps of: receiving, in a stressed state, a hole widening element having at least one engraving including at least one beveled surface in the cannula; axially moving the hole widening element; biasing the ramp upwardly against a shoulder of at least one opening in the wall of the cannula that geometrically interferes with axial movement of the hole widening element; disengaging the surface from the shoulder; allowing the hole widening element to return to a resting state by radially advancing and extending the engraving through the opening and beyond the surface of the cannula; scraping bone from the walls of the hole, A method is provided, comprising:

[0035] According to an aspect of some embodiments of the present invention there is provided a method of removing bone material from a bone, the method comprising the steps of: Axial moving a hole widening element having at least one resilient arm and at least one engraved portion at an end thereof; disposing a geometric interference surface in a travel path of the at least one resilient arm; Engaging the arm with an interference surface to cause bending and deflection; causing the engraved portion to extend radially; scraping bone from the walls of the hole, A method is provided, comprising:

[0036] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device comprising a cannula, a hole widening element having a carving portion and a forward tip, and a single elastic member operable to slide axially relative to the cannula and extend circumferentially, wherein axial movement of the widening element relative to the cannula causes the carving portion to resiliently extend radially to an extended carving position.

[0037] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a single resilient member movably housed in a cannula.

[0038] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein the forward tip is a hole drilling tip.

[0039] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a carving portion attached to at least one barrel portion.

[0040] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a single resilient member displaceably housed within a cannula.

[0041] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein the cannula has a proximal portion having an inner circumference substantially greater than the outer diameter of the thickest portion of the single member.

[0042] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein the cannula further comprises an inner tapered section and a cylindrical section located adjacent a distal end thereof.

[0043] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device in which the inner diameter of the cylindrical portion located at the distal end of the cannula is substantially equal to the outer diameter of the thickest portion of the single member, and which supports primarily axial and rotational movement, but at least non-radial movement, of the single elastic member.

[0044] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device wherein, in operation, the drilling tip acts as a first shaft capture point and a contact point with the hole widening element, and the inner circumference of the cannula acts as a second shaft capture point.

[0045] According to one aspect of some embodiments of the present invention, a bone material removal device is provided in which axial movement of the elastic member relative to the cannula shortens the distance between the first shaft capture point and the second shaft capture point, increasing the stiffness of the hole widening element and radially translating the cutting portion.

[0046] According to an aspect of some embodiments of the present invention, a bone material removal device is provided in which contact of the elastic member with the tip of the cannula creates a third shaft capture from the first shaft capture below a threshold length at which the distal end of the hole widening element loses its elasticity and becomes rigid, causing the cutting portion to translate radially.

[0047] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein the cannula includes an elastic member in a stressed state in which the first and second cylindrical portions are not aligned with the longitudinal axis of the bone material removal device.

[0048] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device in which the elasticity of the elastic member supports the accommodation of the widening element into a hole drilled by a hole drilling tip that matches the hole diameter.

[0049] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein at least an apex of a carved portion does not protrude radially and remains generally aligned with a longitudinal axis of the bone material removal device.

[0050] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, the carving portion comprising at least one carving blade.

[0051] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, wherein the cutting portion comprises at least two first and second cutting blades angled relative to one another and joined at least at one end.

[0052] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein a first chisel blade cuts a major portion of a bone fragment to form a first surface of the fragment and a second chisel blade cuts a second adjacent surface of the fragment to remove the bone fragment.

[0053] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein the hole widening element has at least one chisel at a distal end and comprises at least two distally extending arms separated by a longitudinal recess, the first chisel blade, the second chisel blade, and the angle therebetween defining a rake angle that provides an upwardly facing surface against which removal residue rises and collects in the recess.

[0054] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein the carving portion has a radially positioned curved surface on one side of which a first carving blade abuts and which forms an end relief or clearance curve that prevents friction of the carving portion against the bone.

[0055] According to an aspect of some embodiments of the present invention, there is provided a method of removing bone material from a bone, the method including: drilling a hole in the bone; introducing a single resilient member having a hole widening element having a chiseled portion and a tip through a cannula into the hole, stressing the member to conform to the diameter of the hole; decreasing the distance between a shaft capture point on the member and the tip to reduce the bending moment acting on the chiseled portion and increase the stiffness of the member; and applying a radial force to the chiseled portion to urge it to extend radially to an extended position, chiseling bone from the wall of the hole and forming an undercut in the bone.

[0056] According to an aspect of some embodiments of the present invention, there is provided a method of removing bone material from bone, the method including drilling a hole in the bone; introducing a single elastic member having a hole widening element having a chiseled portion and a tip through a cannula into the hole, stressing the member to conform to the diameter of the hole; reducing the distance between a shaft capture point on the member and the tip to relieve stress on the member; allowing the member to return to a rest position; and providing a radial force to the chiseled portion to urge it to extend radially to an extended position, chiseling bone from the wall of the hole to form an undercut in the bone.

[0057] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device comprising: a forward tip; a cannula; and a widening element configured to slide axially relative to the cannula to move between a rest state and a stressed state and including a bone chiseling portion configured to extend circumferentially; An apparatus is provided in which axial movement of the spreader element relative to the cannula causes the blade to resiliently extend radially to an extended cutting position.

[0058] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device comprising a cannula, a hole widening element having at least one bone chiseling portion and a ramped surface, and a pusher rod, wherein the hole widening element is restricted to radial movement only, and the pusher rod moves axially and engages the ramped surface to actuate the hole widening element in a purely radial direction, thereby causing the chiseling portion to extend radially beyond the surface of the bone material removal device.

[0059] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein movement of the hole widening element is limited by a radial guide mechanism.

[0060] According to one aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein the radial guide mechanism comprises an elongated slot-like notch cut across the width of the hole widening element, the length of the notch being oriented radially from the longitudinal axis of the bone material removal device, and at least one pin is fixed to a wall of the device and protrudes radially inward through the notch.

[0061] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, wherein a hole widening element is resiliently attached to a wall of the device by an elastic attachment that optionally applies a constant tension radially inward.

[0062] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein the resilient mount resists radial outward expansion of the hole widening element.

[0063] According to an aspect of some embodiments of the present invention there is provided a bone material removal device comprising a forward tip and at least one aperture located a predetermined distance proximal to the forward tip.

[0064] According to an aspect of some embodiments of the present invention there is provided a bone material removal device wherein the forward tip is a bone drilling tip.

[0065] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device further comprising a lumen communicating with the atmosphere through an opening, wherein, when at rest, the bone chiseling portion is at least partially retracted into the lumen and disposed within the edge of the opening so as not to protrude.

[0066] According to an aspect of some embodiments of the present invention there is provided a bone material removal device having a beveled tip of a pusher rod.

[0067] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, the carving portion comprising at least one carving blade.

[0068] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, wherein the carving portion further comprises a radially positioned curved surface on one side of which the first carving blade abuts and which forms an end relief or clearance curve that prevents friction of the carving portion against the bone.

[0069] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, wherein the cutting portion comprises at least two first and second cutting blades angled relative to one another and joined at least at one end.

[0070] According to an aspect of some embodiments of the present invention, there is provided a bone material removal device, wherein a first chisel blade cuts a major portion of a bone fragment to form a first surface of the fragment and a second chisel blade cuts a second adjacent surface of the fragment to remove the bone fragment.

[0071] According to an aspect of some embodiments of the present invention there is provided a bone material removal device, wherein a hole widening element has at least one chisel at a distal end and comprises at least two distally extending arms separated by a longitudinal recess, wherein the first chisel blade, the second chisel blade and the angle therebetween define a rake angle that provides an upwardly facing surface along a clearance curve over which removal residue rises and collects in the device.

[0072] According to an aspect of some embodiments of the present invention there is provided a method of removing bone material from a bone, the method comprising the steps of: moving the pusher rod axially while restricting the movement of the hole widening element having the engraved portion and the ramp surface to radial movement only; engaging a pusher rod with the ramp surface to actuate a hole widening element that advances in a purely radial direction; causing the chiseled portion to extend radially beyond the surface of the bone material removal device; Removing part of the bone, A method is provided, comprising:

[0073] According to an aspect of some embodiments of the present invention there is provided a method of axially moving a pusher rod through a lumen of a cannula.

[0074] According to an aspect of some embodiments of the present invention there is provided a method of extending a cutting radially through an opening in a wall of a cannula.

[0075] According to an aspect of some embodiments of the present invention, there is provided a method for radially expanding a cutting against an inward radial tension force caused by a resilient attachment of a hole widening element to a wall of a cannula.

[0076] The present invention, in some embodiments thereof, seeks to provide an improved bone material removal device.

[0077] Thus, in accordance with one embodiment of the present invention, there is provided a bone material removal device comprising a cylindrical element disposed along a longitudinal axis and having a proximal end and a distal end, the distal end having a first cylindrical portion, a second cylindrical portion, and a radially extending projection joining the first and second cylindrical portions and extending radially outward from the longitudinal axis.

[0078] Preferably, the projections extend outward from the longitudinal axis by 0.1 mm to 0.2 mm.

[0079] According to one embodiment of the present invention, a drilling device comprises a cannula having a proximal cylindrical portion of a first diameter and a distal cylindrical portion of a second diameter, the first diameter being substantially larger than the second diameter, and a bone material removal device configured to be inserted and longitudinally displaced relative to the cannula, the bone material removal device having a cylindrical element, the diameter of the cylindrical element being substantially equal to the second diameter.

[0080] According to one embodiment of the present invention, a method for drilling holes of various diameters comprises: The method includes the steps of: providing a cannula; providing a cylindrical element disposed along a longitudinal axis and having a proximal end and a distal end, the cylindrical element configured to be inserted and longitudinally displaced relative to the cannula, the distal end having a radial extension protrusion extending outward from the longitudinal axis; forming a longitudinal hole in the patient's bone by distally advancing the cylindrical element relative to the cannula; and forming an undercut using the radial extension protrusion by further advancing the cylindrical element distally relative to the cannula.

[0081] According to one embodiment of the present invention, a bone material removal device configured for advancement in two stages includes a cylindrical element disposed along a longitudinal axis and having a proximal end and a distal end, the distal end having a first cylindrical portion, a second cylindrical portion, and a radial extension protrusion joining the first and second cylindrical portions and extending outward from the longitudinal axis, wherein in the first stage, the radial extension protrusion deflects and the first cylindrical portion, the second cylindrical portion, and the radial extension protrusion coincide along the longitudinal axis to form a straight hole in the bone.

[0082] In a second step, the radial distraction projections project radially from the longitudinal axis, thereby creating undercuts in the bone.

[0083] According to another embodiment of the present invention, a bone material removal device comprises a drilling element having an outer surface and a widening element arranged along a mutual longitudinal axis, the drilling element and the widening element being longitudinally displaceable relative to each other, the widening element selectively assuming a closed position enabling the drilling of a first hole of a first diameter and an open position enabling the drilling of a second hole of a second diameter, the second diameter preferably being larger than the first diameter.

[0084] The widening element preferably includes a cutting blade that, in the closed position, preferably extends radially to conform to the outer surface of the piercing element.

[0085] More preferably, in the open position, the cutting blades extend radially outward from the outer surface of the piercing element to form an undercut in the patient's bone.

[0086] More preferably, the length of the undercut is a function of the length of the cutting blade.

[0087] According to one embodiment of the present invention, the drilling element further comprises an internal protrusion and the widening element further comprises deflectable arms spaced apart from one another and having at least one widening portion defining a cutting edge, the bone material removal device assuming the open position when the deflectable arms are further spaced apart from one another by sliding over the internal protrusion.

[0088] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of this invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, shall control. Additionally, the materials, methods, and examples are illustrative only and are not necessarily limiting.

[0089] Certain embodiments of the invention are herein described, by way of example, with reference to the accompanying drawings. Reference will now be made specifically to the drawings in detail, and it will be emphasized that the particulars shown are by way of example and for the purpose of illustrating embodiments of the invention. In this regard, the description taken in conjunction with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Brief explanation of the drawings]

[0090] [Figure 1] 1 is a simplified side and enlarged illustration of a bone material removal device outside a patient's bone, constructed and operative in accordance with an embodiment of the present invention, shown in an unstressed orientation; [Figure 2] 2 is a side view and enlarged view of the bone material removal device of FIG. 1 outside the patient's bone shown in a deflected orientation. [Figure 3] 2 is a partial cutaway side view and an enlarged view of the bone material removal device of FIG. 1 inserted into a cannula, showing the cannula positioned on a patient's bone; [Figure 4A] 2 is a partial cutaway side view and enlarged view of the bone material removal device of FIG. 1 inserted into a cannula, showing a first operable drilling orientation within a patient's bone; [Figure 4B] 2 is a simplified cross-sectional view of the cannulated bone material removal device of FIG. 1 illustrating a first operable drilling orientation within a patient's bone; [Figure 5A] 2 is a partial cutaway side view and enlarged view of the bone material removal device of FIG. 1 inserted into a cannula, illustrating a second operable drilling orientation within a patient's bone. [Figure 5B] 2 is a simplified cross-sectional view illustrating a second operable drilling orientation within a patient's bone for the bone material removal device of FIG. 1 inserted into a cannula. [Figure 5C] 2 is a simplified cross-sectional view of the cannulated bone material removal device of FIG. 1 illustrating a second operable drilling orientation within a patient's bone. [Figure 6]2 is a partial cutaway side view and enlarged view of the bone material removal device of FIG. 1 inserted into a cannula, illustrating removal of the bone material removal device from a patient's bone. [Figure 7] 1 is a simplified diagram of a bone material removal apparatus constructed and operative in accordance with an embodiment of the present invention; [Figure 8A] 8 is a simplified diagram of a drilling element of the bone material removal device of FIG. 7. [Figure 8B] 8B is a simplified cross-sectional view and enlarged view of the piercing element of FIG. 8A taken along line BB of FIG. 8A. [Figure 9A] 8A and 8B are simplified and cross-sectional views of a hole widening element of the bone material removal device of FIG. 7. [Figure 9B] 9B is a simplified cross-sectional view of the hole widening element of FIG. 9A taken along line BB of FIG. 9A. [Figure 10A] 8A-8C are two different simplified plan views (front and side views, respectively) showing the assembled bone material removal device of FIG. 7 in a closed operating orientation. [Figure 10B] 10B is a simplified partial cross-sectional view of the assembled bone material removal device of FIG. 7 in a closed operational orientation along line BB of FIG. 10A. [Figure 10C] 1 is a simplified side view of an assembled bone material removal device in a closed operational orientation within a patient's bone. [Figure 10D] FIG. 10D is an enlarged view of FIG. 10C showing the assembled bone material removal device in a closed operating orientation within the patient's bone. [Figure 11] 13 is a simplified front and partial cross-sectional view of the example assembled bone material removal device of FIG. 7 in a transitional operating orientation between the closed orientation position of FIG. 10 and the open orientation of FIG. 12. [Figure 12A] 8A-8C are two different simplified plan views (front and side views, respectively) showing the assembled bone material removal device of FIG. 7 in an open operating orientation. [Figure 12B] 12B is a simplified partial cross-sectional view of the assembled bone material removal device of FIG. 7 in an open operating orientation along line BB of FIG. 12A. [Figure 12C] 1 is a simplified side view of an assembled bone material removal device in an open operating orientation within a patient's bone. [Figure 12D] 12D is an enlarged view of FIG. 12C showing the assembled bone material removal device in an open operating orientation within the patient's bone. [Figure 13A] 10 is a simplified cross-sectional view of another embodiment of a bone material removal device. [Figure 13B] 10 is a simplified cross-sectional view of another embodiment of a bone material removal device. [Figure 14A] 10 is a simplified cross-sectional view of another embodiment of a bone material removal device. [Figure 14B] 10 is a simplified cross-sectional view of another embodiment of a bone material removal device. DETAILED DESCRIPTION OF THE INVENTION

[0091] The term "bone material removal device" as used in this disclosure should be taken to mean a device that separates some bone material from bone in any form, whether or not the separated material is removed from the bone.

[0092] The term "chisel blade" as used in this disclosure should be taken to mean an edge of a portion of a bone material removal device that operates to separate some bone material in any form from the bone.

[0093] As used in this disclosure, the term "chisel" should be taken to mean the portion of the bone material removal device that includes the chisel blade.

[0094] In this disclosure, the terms "shaft capture" and "shaft capture point" are used interchangeably and refer to a point of contact between a shaft and a surrounding surface that temporarily restricts radial movement of the shaft at that location.

[0095] Disclosed herein is a bone material removal device that is particularly useful for drilling small diameter holes having one or more portions with different diameters.

[0096] One aspect of some embodiments of the present invention relates to a bone material removal device in which axial movement of at least a portion of the device is converted into radial extension of one or more cutting portions. In some exemplary embodiments of the present invention, this conversion does not constrain the axial movement of the portion of the removal device. Optionally or alternatively, this conversion is due to a geometric interference with the axial movement, where the interference converts the axial movement into radial extension, while, optionally, axial movement past the interference is possible and therefore unconstrained. In some exemplary embodiments of the present invention, the bone removal device is a single, integral element constructed entirely of one material (e.g., metal). In some exemplary embodiments of the present invention, the bone removal device is constructed of two or more portions, one that moves axially and one that moves radially.

[0097] In some exemplary embodiments of the invention, the radial movement extends the chiseled portion from a reduced diameter smaller than (or no more than 10%, 20%, or any intermediate percentage larger than) the hole in the bone and / or the diameter of an imaginary axial extension of the surrounding cannula or distal cannula, to an enlarged diameter extending radially beyond the surface of the cannula and / or the surface of said imaginary extension (e.g., extending 10%, 20%, 30%, 40%, 50%, or any intermediate percentage or more of the radius (e.g., normal diameter without the widening portion) of the cannula or its imaginary axial extension and / or hole).

[0098] In some exemplary embodiments of the invention, the bone removal device includes a carving portion that translates to a new radial position. In some exemplary embodiments of the invention, this portion does not pivot and / or rotate about an axial hinge. As a particular feature of some embodiments of the invention, the carving portion is rigid. Optionally, the carving portion has a cross-section that is, for example, at least 20%, 40%, 60%, 70%, or any intermediate percentage or greater of the cross-section of the lumen of the cannula in which it is located. Optionally or alternatively, this portion is rigid and does not flex upon deployment, with any flexing occurring in portions other than the carving portion of the device. In some exemplary embodiments of the invention, rigidity is provided by the material of the portion that optionally extends in a purely radial direction from the inside of the cannula to the outside of the cannula that it supports. Optionally, such extension is provided over at least 50%, 60%, 80%, or more, or any intermediate percentage, of the axial length of the carving blade of the carving portion.

[0099] In some exemplary embodiments of the invention, the translation is relative or substantially pure radial translation, including, for example, less than 75%, 60%, 30%, 20%, 10% or less of the axial translation as a percentage of the radial translation distance, or any intermediate percentages thereof.

[0100] In some exemplary embodiments of the invention, radial movement includes bending of the bone removal device, but excludes bending at the chisel blade and / or bending at angles greater than 10°, 20°, 30°, 40°, 50°, or any intermediate angles. Optionally or alternatively, any bending is at a bend radius greater than 1 mm, 3 mm, 5 mm, 10 mm, intermediate angles, or greater.

[0101] In some exemplary embodiments of the invention, any bending is due to a force applied radially to the engraved portion, rather than an axially applied force.

[0102] An aspect of some embodiments of the present invention relates to a method for converting an axial force applied against a surface by axial movement of a hole widening element into a radial force to radially deflect a cutting portion into an extended circumferential position.

[0103] One aspect of some embodiments of the present invention relates to a resilient bone material removal device that is a single member movably housed in a cannula. The bone material removal device may include a hole drilling tip and a hole widening element that is a protrusion with a chiseled portion disposed between two cylindrical portions. In operation, the drilling tip may act as a contact point with the first shaft capture and the hole widening element, and the inner circumference of the cannula may act as a second shaft capture point. Axial movement of the device relative to the cannula changes the position of the second shaft capture and shortens the distance between the first and second shaft captures, increasing the stiffness of the hole widening element. Further axial movement brings the hole widening element into contact with the tip of the cannula and creates a third shaft capture that is the shortest distance from the first shaft capture (hole drilling tip) relative to the distance of the second shaft capture from the drilling tip. When the distance between the third and first shaft captures falls below a maximum hole widening element distal end threshold length at which the distal end of the hole widening element loses its elasticity, stiffness increases and the cutting portion translates radially, thereby achieving, for example, an undercut.

[0104] One aspect of an embodiment of the present invention relates to a resilient bone material removal device comprising a widening element having a carving portion at an end thereof and one or more resilient arms that are biased to move axially and engage a fixed surface that bends to radially deflect the carving portion. Alternatively and optionally, the hole widening element comprises one or more arms with a carving portion that can be fixed in position and are biased by a movable surface that moves axially and engages the hole widening element to bend the arms and radially deflect the carving surface.

[0105] One aspect of an embodiment of the present invention relates to a hole widening element comprising one or more cutting portions that can be limited to radial movement only, and a pusher rod that engages the hole widening element by axial movement and activates the hole widening element in a purely radial direction, thereby causing the cutting portions to advance and extend radially beyond the surface of the bone material removal device.

[0106] One aspect of an embodiment of the present invention relates to a resilient bone material removal device comprising one or more cutting portions having a proximal inward tapered or beveled surface and a hole widening element receivable in a cannula under stress, wherein axial displacement of the hole widening element along the cannula causes the proximal inward tapered or beveled surface to slide over and against a shoulder of an opening in the cannula wall, eventually disengaging from the shoulder and allowing gradual radial extension of the one or more cutting blades through the opening caused by the tendency of the hole widening element to return to its original rest state.

[0107] One aspect of an embodiment of the present invention relates to a bone material removal device that includes a movable hole widening element that is a single resilient member having a carving portion, wherein axial movement of the hole widening element relative to a fixed deflection surface causes a non-carving end of the hole widening element to contact and deflect against the fixed surface, thereby advancing and extending the carving portion radially beyond the surface of the cannula and scraping bone from the wall of the hole. Alternatively and optionally, the hole widening element may be fixed and the deflection surface may be movable and move axially to engage the fixed hole widening element and flex the arms to radially deflect the carving portion.

[0108] In addition to the above and optionally, some embodiments of the present invention relate to a bone material removal device comprising a hingeless mechanism that enables transition of the device from a rest state to a stressed state and vice versa and that operates to translate axial movement of a hole widening element having one or more cutting blades relative to a cannula into radial movement and extension of the cutting blades.

[0109] Additionally and alternatively to the above, some embodiments of the present invention relate to a cannulated bone material removal device that includes a mechanism that operates to collect and remove residue and debris, such as bone fragments, from the formed undercut and store the debris in the cannula.

[0110] 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 drawings, and / or examples. The invention is capable of other embodiments and of being practiced or carried out in various ways.

[0111] Reference is now made to FIG. 1, which is a simplified side and enlarged illustration of a bone material removal device constructed and operative in accordance with one embodiment of the present invention and located outside a patient's bone in an unstressed or resting state.

[0112] 1 illustrates a bone material removal device 100 that may be a single resilient member having both a hole-punching tip 116 and a radially protruding circumferential hole widening element 110 having a chiseled portion. The bone material removal device 100 may have a proximal end 102 and a distal end 104. The device 100 may be primarily disposed along a longitudinal axis 105 and may be constructed of a biocompatible shape memory alloy, such as Nitinol.

[0113] 1, bone material removal device 100 may optionally be configured as a cylinder across a majority of its longitudinal extent, with the cylinder optionally having a diameter ranging from 0.5 mm to 3 mm, alternatively and optionally ranging from 0.5 mm to 2.5 mm, alternatively and optionally ranging from 1 mm to 2 mm.

[0114] As a particular feature of one embodiment of the present invention, the distal end 104 of the bone material removal device 100 may optionally have a first generally cylindrical portion 106 terminating in a distally opposed shoulder 107, a second generally cylindrical portion 108, and a hole widening element that extends slightly radially so that the hole widening element does not deviate from the diameter of the hole drilled by the hole drilling tip 116. In some embodiments, the hole widening element may extend radially relative to the longitudinal axis 105 in, for example, a conical, arcuate, triangular, or any other shape.

[0115] In the embodiment of FIG. 1 , the hole widening element is a slightly radially extending eccentric protrusion 110 having a generally convex outer surface 112 with engravings along its entire length and a generally concave inner surface 114. In other embodiments, the inner surface 114 may have other geometric shapes. For example, the inner surface 114 may be flat, forming a triangular protrusion 110. The protrusion 110 optionally joins the first cylindrical portion 106 and the second cylindrical portion 108. In the unstressed position of the embodiment shown in FIG. 1 , the protrusion 110 may optionally extend outward from the longitudinal axis 105 by 0.05 to 0.4 mm, alternatively and optionally 0.075 to 0.3 mm, alternatively and optionally 0.1 to 0.2 mm.

[0116] It should be noted that in the embodiment of FIG. 1, the outer diameter of the distal end 104 of the bone material removal device 100 is smaller than the outer diameter of the remainder of the bone material removal device 100 .

[0117] In the unstressed position of the embodiment shown in FIG. 1, the majority of the longitudinal extent of the bone material removal device 100 is disposed along the longitudinal axis 105, with the exception of the protrusions 110 which may extend radially outward.

[0118] A hole drilling tip 116 at the distal end 104 of the bone material removal device 100 may be located distally from the second cylindrical portion 108 .

[0119] Optionally, the length of distal tip 104 is greater than a threshold length, e.g., 10 mm, such that it is not rigid. As will be explained in more detail below, this feature allows the stiffness of distal tip 104 to be varied as needed by increasing or decreasing the distance between hole-punching tip 116 and a shaft capture point located along device 100. In other words, as the distance between hole-punching tip 116 and a shaft capture point located along device 100 decreases, the stiffness of distal tip 104 increases toward a threshold length (e.g., 8 mm) at which distal tip 104 becomes completely rigid.

[0120] Optionally, the length of distal end 104 may range from 10 mm to 25 mm, alternatively and optionally from 13 mm to 23 mm, alternatively and optionally from 15 mm to 20 mm.

[0121] Of course, in the unstressed or resting state of the bone material removal device 100 seen in FIG. 1, the first cylindrical portion 106 and the second cylindrical portion 108 are aligned with each other along the longitudinal axis 105.

[0122] Referring now to Figure 2, which is a side view and close-up of the embodiment of the bone material removal device 100 of Figure 1 under stress. The example shown in Figure 2 highlights the elastic nature of the bone material removal device 100, which stems from the material properties of, for example, a shape memory alloy. As shown in Figure 2, when the bone material removal device 100 is outside the patient's bone, it can elastically deform into a biased orientation when stressed. However, due to its elastic and shape memory properties, the bone material removal device 100 can return to its original, unstressed, or resting, shape shown in Figure 1 when the stress is released.

[0123] 2, the distal end 104 of the bone material removal device 100 is deflected radially due to the elastic properties of the bone material removal device 100. The first cylindrical portion 106 and the second cylindrical portion 108 are not aligned with the longitudinal axis 105. At this stage, the elasticity of the distal end 104 of the elastic member that is the bone material removal device 100 accommodates the distal end 104 being accommodated in the hole drilled by the hole drilling tip 116, which matches the hole diameter, and at least the apex, if not all, of the engraved portion of the convex outer surface 112 does not protrude radially and remains generally aligned with the longitudinal axis 105.

[0124] Reference is now made to FIG. 3, which is a partial cutaway side view and enlarged view of the bone material removal device 100 of FIG. 1 inserted into a cannula, with the cannula positioned on a patient's bone.

[0125] The embodiment of the bone material removal device in FIG. 3 illustrates an example of a bone material removal device 100 having a handle 122 at a proximal end 124 and a longitudinal cannula 126 at a distal end 128, inserted into a drilling guide tool 120 disposed along a longitudinal axis 105. The cannula 126 has a toothed tip 130 at its distal end that securely positions the cannula in position on a patient's bone 200. The drilling guide tool 120 is positioned on the patient's bone 200 such that the toothed tip 130 of the cannula 126 engages the bone 200 and the bone material removal device 100 inserted in the cannula 126, and may extend along a proximal cylindrical portion 134 and terminate proximal to an inner tapered portion 136. In the example of FIG. 3, the bone material removal device 100 is shown positioned in an unstressed or stationary state similar to that of FIG. 1.

[0126] Referring now to FIG. 4A, this is a partially cut-away side view and enlarged view showing a first operable drilling orientation within a patient's bone 200 for the bone material removal device 100 of FIG. 1 inserted into a cannula 126.

[0127] The cannula 126 may have a proximal cylindrical portion 134 having an inner periphery 132 of a first diameter (d1), an inwardly tapered portion 136 located adjacent the distal end 128 of the cannula 126, and a cylindrical portion 138 located at the distal end 128 of the cannula 126, the cylindrical portion 138 having an inner periphery of a second diameter (d2). Of course, the first diameter of the inner periphery 132 of the portion 134 may be substantially larger than the second diameter (d2) of the distal-most cylindrical portion 138 at the distal end 128. The outer diameter (d3) of the bone material removal device 100, excluding the distal end 104, may be substantially equal to the second diameter (d2) of the inner periphery of the cylinder 138 at the distal end 128 of the cannula 126, thereby accommodating primarily radial, axial, and rotational movement of the device 100, at least fixation, at the inner periphery (d2) of the distal portion 128 of the cylindrical portion 138.

[0128] 4A, 4B, 5A, 5B, and 5C, which are simplified cross-sectional views of example operational stages of bone material removal device 100 at various times during distal advancement into a patient's bone 200. It will be apparent to those skilled in the art that the operational stages of FIGS. 4A-5B disclosed below illustrate the conversion of bone material removal device 100 from a hole-punching device to an undercut-generating device, e.g., by converting axial movement of device 100 into radial translation and extending one or more cutting edges of protrusions 100 as bone material removal device 100 transitions from a resting state to a stressed state, or vice versa. These steps may generally be performed sequentially.

[0129] 4A and as described above, there is a degree of freedom between bone material removal device 100 and cannula 126, and the elastic properties of bone material removal device 100 allow bone material removal device 100 to be advanced distally longitudinally along longitudinal axis 105. This degree of freedom is provided by the fact that the outer diameter (d3) of the remainder of bone material removal device 100, excluding distal end 104, i.e., the thickest portion of device 100, is substantially smaller than the first diameter (d1) of proximal cylindrical portion 134 of cannula 126.

[0130] As shown in FIG. 4B , during the insertion phase of the bone material removal device 100 shown in FIG. 4A , the device 100 is free to move radially about the inner circumference 132 of the cannula 126, so that a contact point (not shown) of the inner circumference 132 of the portion 134 with the bone material removal device 100 can constitute a first shaft capture, and the bone surrounding the drilling tip 116 (i.e., hole 202 in FIG. 5 ) can constitute a second shaft capture. The specific location of the first contact point (capture) can vary throughout the drilling process. Additionally, the distance between the first and second shaft captures can create a first bending moment in the bone material removal device 100, causing the device 100 to elastically deform into the stressed state shown in FIG. 2 . In this state, the elastic properties of the device 100 cause the protrusions 110 to bend under bending forces, aligning with the longitudinal axis 105 and the first and second cylindrical portions 106, 108 to match the diameter of the hole drilled by the hole drilling tip 116, thereby allowing the device 100 to be advanced longitudinally within the patient's bone 200, forming a small diameter hole therein.

[0131] As a particular feature of one embodiment of the present invention, in some embodiments, at this stage the first cylindrical portion 106, the second cylindrical portion 108, and the protrusion 110 are aligned with one another along the longitudinal axis 105 and have a diameter less than or equal to the radius of the hole drilled by the hole drilling tip 116 in the operating orientation shown in Figures 4A and 4B, while the distal opposing shoulder 107 is still not engaged with the distal-most cylindrical portion 138 of the cannula 126.

[0132] 4A and 4B, a straight longitudinal hole 202 is formed in the patient's bone 200 by distal advancement of the bone material removal device 100. In FIG.

[0133] The longitudinal hole 202 formed in this operating orientation optionally has a diameter in the range of 2 mm to 4 mm, alternatively and optionally in the range of 1.5 mm to 3 mm, alternatively and optionally in the range of 1 mm to 2 mm, corresponding to the outer diameter of the first cylindrical portion 106 and the second cylindrical portion 108.

[0134] Reference is now made to Figures 5A, 5B, and 5C, which are partially cut-away side views, enlarged views, and simplified cross-sectional views illustrating a second operable drilling orientation within a patient's bone 200 for an embodiment of the bone material removal device 100 of Figure 1 inserted into a cannula 126.

[0135] 5A, the bone material removal device 100 has been advanced further distally into the patient's bone 200. The further distal advancement of the bone material removal device 100 can range from about 1 mm to 8 mm, alternatively and optionally 1.5 mm to 7 mm, alternatively and optionally 2 mm to 6 mm.

[0136] As a particular feature of one embodiment of the present invention, at this stage shown in FIG. 5A and more particularly in FIG. 5B, shoulder 107 and the adjacent portion of device 100 have moved further axially into the distal-most cylindrical portion 138 of cannula 126, and there is no longer any radial degree of freedom between bone material removal device 100 and cannula 126.

[0137] This degree of freedom is lost due to the fact that the outer diameter of the remainder of the bone material removal device 100 , except for the distal end 104 , mates with a substantially equal outer diameter of the distal-most cylindrical portion 138 of the cannula 126 .

[0138] At this point, the bone surrounding drilling tip 116 (i.e., hole 202) may remain in the second shaft capture, but distal-most cylindrical portion 138 becomes the third shaft capture, replacing the second shaft capture located at the contact point along inner circumference 132 of portion 134. Additionally, the distance between the first and third shaft captures being shorter than the distance between the second and first shaft captures creates a second, smaller bending moment in bone material removal device 100, resulting in a threshold length (e.g., the tip of a cannula) designated by the letter (L) in FIG. 5B where distal end 104 becomes completely rigid.

[0139] Due to the increased stiffness (reduced bending moment) and shape memory properties of the material comprising bone material removal device 100, device 100 tends to return to its original resting state as shown in Figure 1, so that a radial force, indicated by the arrows labeled with reference numeral 550 in Figure 5B, is applied to protrusion 110, urging protrusion 110 to extend radially. Thus, as a particular feature of one embodiment of the present invention, axial movement of a hole widening element in the form of protrusion 110 relative to cannula 126 increases the stiffness of distal end 104, causing the chiseled portion of protrusion 110 to extend radially to a radially extended position.

[0140] 5C , as the rigidity of distal end 104 increases, protrusions 110 extend radially and rotate about longitudinal axis 105 to create an undercut in patient's bone 200, increasing their diameter and forming hole (undercut) 204 with a diameter substantially larger than that of hole 202. The rigidity of bone material removal device 100 at this stage causes protrusions 110 to protrude radially outward from longitudinal axis 105, allowing bone material removal device 100 to advance longitudinally within patient's bone 200 to create a larger diameter hole corresponding to the outer diameter created by protrusions 110.

[0141] As a particular feature of one embodiment of the present invention, at this point, in the operational orientation shown in Figures 5A-5C, first cylindrical portion 106 and second cylindrical portion 108 are aligned with one another along longitudinal axis 105, and distal opposing shoulder 107 engages distal-most cylindrical portion 138 of cannula 126, preventing protrusion 110 from losing rigidity, thereby causing protrusion 110 to extend radially outward relative to longitudinal axis 105.

[0142] The undercuts 204 formed in the operating orientation shown in Figures 5A-5C optionally have a diameter ranging from 0.6 mm to 3.2 mm, alternatively and optionally from 1 mm to 2.8 mm, alternatively and optionally from 1.2 mm to 2.4 mm, corresponding to the outer diameter of the protrusions 110 in their most radially extended configuration.

[0143] 5A-5C, further distal advancement of bone material removal device 100 has created an undercut 204 approximately in the middle of a straight longitudinal bore 202 formed in the patient's bone 200. In FIG.

[0144] Referring now to FIG. 6, this is a partial cutaway side view and enlarged view of the embodiment of the bone material removal device of FIG. 1 inserted into the cannula 126, illustrating the removal of the bone material removal device 100 from the patient's bone 200.

[0145] In FIG. 6, the bone material removal device 100 is withdrawn from a patient's bone 200, which has been formed with holes of different diameters: a small longitudinal hole 202 and a large undercut 204.

[0146] Reference is now made to FIG. 7, which is a simplified diagram of a bone material removal apparatus 300 constructed and operative in accordance with another embodiment of the present invention.

[0147] 7, bone material removal device 300 optionally includes a drilling element 302 having a proximal end 310 and a distal end 312, optionally in the form of a cannula, and constructed of a biocompatible metal. Distal end 312 may be sealed by a tapered drilling tip 314. Drilling element 302 may optionally have a diameter ranging from 2 mm to 4 mm, alternatively and optionally from 1.5 mm to 3 mm, alternatively and optionally from 1 mm to 2 mm. Device 300 may also include a hole widening element 304 disposed between and at least partially inserted into distal end 312 and proximal end 310 of drilling element 302.

[0148] The drilling element 302 is connected at its proximal end 301 to a handle 306 into which a pushing element 308 is inserted, which is in contact with the hole widening element 304. Alternatively and optionally, the drilling element 302 and the hole widening element 304 are connectable to a power tool (e.g., a power drill). The drilling element 302 and the hole widening element 304 are arranged along a mutual longitudinal axis 309.

[0149] As a particular feature of one embodiment of the present invention, the hole widening element 304 may be at least partially inserted into the drilling element 302 and selectively positionable between a closed position capable of drilling a hole of a first diameter in the patient's bone and a radially extending open position capable of drilling a hole of a second diameter in the patient's bone, the first diameter optionally being equal to the outer diameter of the tubular or cannulated portion of the drilling element 302 and the second diameter being greater than the first diameter to form an undercut in the patient's bone.

[0150] Reference is now made to Figure 8A, which is a simplified diagram of the drilling element 302 of the bone material removal device 300 of Figure 7. Reference is also made to Figure 8B, which is a simplified cross-sectional and enlarged view of the drilling element 302 of Figure 8A taken along line BB of Figure 8A.

[0151] Piercing element 302 may optionally be integrally constructed of a biocompatible material (eg, metal) and disposed along longitudinal axis 309 .

[0152] 8A and 8B , one or more through apertures 320 in a wall 335 of the piercing element 302 extend radially through the piercing element 302, transverse to the longitudinal axis 309. An inner surface 336 of the wall 335 of the piercing element 302 defines a hollow portion of the piercing element 302 proximal to the apertures 320 and, optionally, a solid portion distal to the apertures 320.

[0153] Each of the apertures 320 extends longitudinally from a distally opposed shoulder 322 to a proximally opposed shoulder 324 .

[0154] Of course, the piercing tip 314 can be fixedly coupled to or integral with the piercing element 302 .

[0155] In the example seen in FIG. 8B , the solid portion of the piercing element 302 extends proximally from the piercing tip 314 to approximately adjacent the proximally-facing shoulder 324, defining a proximal-facing surface 326 at this location. An optional protrusion 328 extends proximally from this surface 326. The protrusion 328 shown in FIG. 8B optionally includes a cylindrical portion 330 and a proximal portion 332 having one or more angled surfaces (e.g., conical or tapered) extending proximally therefrom. Of course, the protrusion 328 can alternatively be configured as a cone or any other widening shape (e.g., pyramidal or any other suitable shape) along its entire longitudinal extent. According to the exemplary embodiment of the invention shown in FIG. 8A , the conical portion 332 defines one or more radially extending, distally extending tapered or angled surfaces 334. For example, conical portion 332 may define two distally extending tapered or inclined surfaces 334 that extend in opposite radial directions.

[0156] The hollow portion of the piercing element 302 defines a wall 335 having an outer surface 337 and an inner surface 336. do.

[0157] Reference is now made to Figure 9A, which is a simplified diagram and cross-sectional view of one example of the hole widening element 304 of the bone material removal device 300 of Figure 7. Reference is also made to Figure 9B, which is a simplified cross-sectional view of the hole widening element 304 of Figure 9A taken along line BB of Figure 9A.

[0158] The hole widening element 304 optionally has a proximal end 350 and a distal end 352, can be integrally constructed of an elastic biocompatible material (e.g., metal) with shape memory properties, and can be positioned along a longitudinal axis 309.

[0159] 9B, a generally cylindrical recess 354 is formed in proximal end 350 for engagement with pusher element 308 (FIG. 7). Recess 354 extends distally from proximal end 350 and terminates in a proximally facing surface 356.

[0160] Optionally, one or more distally extending arms 358 extend from approximately the middle of the longitudinal extent of the hole widening element 304 to the distal end 352, and a longitudinal recess 360 having a proximal closed end and a distal open end abuts and separates centrally facing surfaces of the distally extending arms 358. Each arm 358 defines an outer surface 362.

[0161] As shown in Figures 9A and 9B, the arms 358 of the hole widening element 304 are not parallel to one another but may gradually converge, and in some instances may contact one another distally from the proximal closed end of the longitudinal recess 360. As described in more detail below, in one embodiment, the hole widening element 304 shown in Figures 9A and 9B may be in an unstressed, resting state such that the arms 358 may deflect inward toward one another when a radially inward force is applied to the outer surface 362. When a radially outward force is applied to the inner surfaces of the arms 358, the arms 358 may deflect outward and further separate from one another. In another embodiment, the hole widening element 304 shown in Figures 9A and 9B may be in a stressed or loaded state.

[0162] Each arm 358 defines a widened portion 364 at the distal end 352 of the widened element 304. Each widened portion 364 preferably defines a distally facing (preferably inward-proximal) tapered or beveled surface 366. The inward-proximal tapered or beveled surface 366 defines a distal surface of a carving portion 368 extending proximally therefrom. The carving portion 368 is widened generally longitudinally to define an outer carving blade 370 or blades 370, described in more detail below, and a radially positioned curved surface 921 on one side where the carving blade 370 abuts, forming an end relief or clearance curve that prevents friction of the carving portion 368 against bone, thereby reducing the force (e.g., torque) required to operate the device 300. The longitudinal engraving 368 is joined to the outer surface 362 of the arm 358 by a generally proximal inward tapered or beveled surface 372. Of course, the longitudinal engraving 368 can be cylindrical or conical or any other suitable shape.

[0163] Of course, the widened portions 364 may be positioned generally at an angle to one another.

[0164] In some embodiments, the hole widening element 304 may have a single arm 358 with one or more engravings 368. In other embodiments, the hole widening element 304 may have two or more arms, only one of which may have one or more engravings 368.

[0165] 10A-10D, 11, and 12A-12D, collectively referred to as FIG. 10, which are simplified illustrations of example operational stages of bone material removal device 300 at various times during distal advancement into patient's bone 200. It will be apparent to those skilled in the art that the operational stages disclosed below illustrate the conversion of bone material removal device 300 from a hole drilling device to an undercut generating device, for example, by converting axial movement of device 300 into radial translation and extending one or more cutting portions of arms 358 of hole widening element 304 through one or more apertures 320 as bone material removal device 300 transitions from a resting state to a stressed state, or vice versa. These steps may generally be performed sequentially.

[0166] Reference is now made to Figure 10A, which is two different simplified plan views (front and side views, respectively) illustrating one example of the assembled bone material removal device 300 of Figure 7 in a closed operating orientation. Reference is also made to Figure 10B, which is a simplified partial cross-sectional view of the assembled bone material removal device 300 of Figure 7 in a closed operating orientation along line BB in Figure 10A. Reference is also made to Figure 10C, which is a simplified side view of the assembled bone material removal device 300 in a closed operating orientation within a patient's bone. Reference is also made to Figure 10D, which is an enlarged view of Figure 10C showing the assembled bone material removal device 300 in a closed operating orientation within a patient's bone.

[0167] In the example of FIGS. 10A-10D, hole widening element 304 is inserted into drilling element 302 so that they are mutually aligned along longitudinal axis 309.

[0168] Also, because the pusher element 308 is not yet fully inserted into the handle 306, the hole widening element 304 is positioned proximally and stationary (FIG. 10B), providing a closed operating orientation for the bone material removal device 300. In this proximal position, the pusher element 308 does not engage the proximally facing surface 356 of the recess 354 of the hole widening element 304.

[0169] The widening portions 364 of the arms 358 of the hole widening element 304 are each positioned within a respective opening 320 of the piercing element 302, with a proximal inward tapered or inclined surface 372 positioned adjacent to a distal opposing shoulder 322 defined by the opening 320 of the piercing element 302.

[0170] Because the distally facing (preferably inward proximal) tapered or beveled surface 366 of the hole widening element 304 does not engage the distally extending tapered or beveled surface 334 of the protrusion 328 of the piercing element 302, the arms 358 of the hole widening element 304 are positioned in a closed rest-state operating orientation. At this point, the arms 358 may optionally be biased radially inward toward one another, approximately slightly, by a radially inward force applied by the inner surface 336 of the piercing element 302 to the proximal inward tapered or beveled surface 372 of the widened portion 364 of the arms 358 of the hole widening element 304.

[0171] As a particular feature of one embodiment of the present invention, in the closed operating orientation of the bone material removal device 300, the scraping blade 370 of the hole widening element 304 may extend slightly radially to coincide only with the outer surface 337 of the drilling element 302. Thus, the drilling radius of the outer surface of the drilling element 302 is substantially equal to the drilling radius formed by the scraping blade 370 of the hole widening element 304, thereby forming an initial hole 400 of a first diameter in the patient's bone 402, as can be seen particularly in Figures 10C and 10D.

[0172] The radius of the initial drilled hole can be, for example, between 0.2 mm and 1.4 mm, alternatively and optionally between 0.4 mm and 1.2 mm, alternatively and optionally between 0.5 mm and 1 mm, or any other radius, and is preferably equal to the outer diameter of the drilling element 302.

[0173] FIG. 11 is a simplified front and partial cross-sectional view of one example of an embodiment of the assembled bone material removal device 300 of FIG. 7 in a transitional operating orientation between the closed orientation position of FIGS. 10A-10D and the open orientation of FIGS. 12A-12D.

[0174] At the time shown in FIG. 11, a portion of the pushing element 308 has advanced axially distally and a portion has been inserted into the handle 306, so that its distal end engages with the hole widening element 304 and displaces the hole widening element 304 axially and distally, with the tapered or inclined surface 334 of the protrusion 328 engaging this portion.

[0175] The pushing element 308 may be attached and locked into the recess 354 by a quick release system, alternatively or optionally by a screw mechanism, and by rotating the pushing element 308 the widening element 304 can be moved incrementally axially as required.

[0176] The axially and distally displaced hole widening element 304 may move axially to engage the distally extending tapered or inclined surface 334 of the protrusion 328 which geometrically interferes with the axial movement of the hole widening element 304 and apply a radial bending force to the arms 358 of the hole widening element 304 causing the cutting portion to progress and extend radially outward through one or more openings 320.

[0177] Reference is now made to Figure 12A, which is two different simplified plan views (front and side views, respectively) of the assembled bone material removal device 300 of Figure 7 in a fully open operational orientation. Reference is also made to Figure 12B, which is a simplified partial cross-sectional view of the assembled bone material removal device 300 of Figure 7 in a fully open operational orientation along line BB of Figure 12A. Reference is also made to Figure 12C, which is a simplified side view of the assembled bone material removal device 300 in a fully open operational orientation within a patient's bone. Reference is also made to Figure 12D, which is an enlarged view of Figure 12C showing the assembled bone material removal device 300 in a fully open operational orientation within a patient's bone.

[0178] 12A-12D, hole widening element 304 remains inserted into piercing element 302 so that they are aligned relative to one another along longitudinal axis 309. In FIGS.

[0179] As a particular feature of one embodiment of the present invention, the hole widening element 304 is fully axially displaced relative to the drilling element 302 .

[0180] In particular, at this stage, the pusher element 308 is fully inserted into the handle 306, and a distal end (not shown) engages the proximally facing surface 356 of the recess 354 in the hole widening element 304, thereby displacing the hole widening element 304 axially and distally and positioning it distally to an open operating orientation of the bone material removal device 300. Of course, instead of utilizing the handle 306 and pusher element 308, a power tool can alternatively and optionally be used that selectively changes the closed and open operating orientations of the bone material removal device 300 by changing the direction of rotation of the power tool without requiring manipulation of a mechanical means, such as the pusher element 308.

[0181] Distal displacement of the hole widening element 304 causes the widening portions 364 of the arms 358 of the hole widening element 304 to slide longitudinally relative to the opening 320 of the piercing element 302, with the distally facing (preferably inwardly proximal) tapered or inclined surfaces 366 of the hole widening element 304 engaging and sliding along the distally extending tapered or inclined surfaces 334 of the projections 328 of the piercing element 302. This causes the tapered or inclined surfaces 334 to enter longitudinal recesses 360 formed between the arms 358 of the hole widening element 304, geometrically interfering with the axial movement of the arms 358 of the hole widening element 304, thereby deflecting the arms 358 of the hole widening element 304 radially outward. As the arms 358 succumb to the applied bending force, they are forced apart by the radially outward force applied by the distally extending tapered or inclined surface 334 and enter the longitudinal recess 360 formed between the arms 358 of the hole widening element 304, causing radial displacement and extension of the cutting portion 368 through the one or more openings 320, thereby positioning the cutting portion 368 in a fully extended position and the bone material removal device 300 in a fully open operating orientation.

[0182] 12A-12D , a distally facing (preferably inward proximal) tapered or inclined surface 366 may be positioned adjacent to a proximally facing shoulder 324 defined by the opening 320 of the piercing element 302 and the engraving portion 368 and engraving blade 370 locked in a radially extended position by the cylindrical portion 330 of the projection 328. The cylindrical portion 330 of the projection 328 thereby supports the engraving portion 368 in the extended position and acts as a counter-support to counteract radial forces directed toward the center and prevent the engraving portion 368 from retracting into the piercing element 302.

[0183] Thus, as a particular feature of one embodiment of the present invention, axial movement of the hole widening element 304 relative to the protrusion 328 causes one or more of the engraved portions 368 of the arms 358 of the hole widening element 304 to resiliently extend radially to a radially extended position.

[0184] As a particular feature of one embodiment of the present invention, in the open operating orientation of the bone material removal device 300, the chisel blades 370 of the hole widening element 304 extend radially outward from the outer surface 337 of the drilling element 302 through one or more apertures 320, such that the chisel blades 370 operate to chip bone from the wall of the hole and form undercuts in the bone. As such, the diameter of the drilled hole formed by the chisel blades 370 of the hole widening element 304 is substantially larger than the diameter of the drilled hole initially formed by the drilling tip 314 of the drilling element 302.

[0185] 12C and 12D, an undercut 404 of a second diameter is formed over an initial hole 400 of a first diameter in a patient's bone 402, the second diameter being substantially larger than the first diameter. The radius of the undercut can range, for example, from 1.5 mm to 2.5 mm, alternatively and optionally from 1 mm to 2 mm, alternatively and optionally from 0.75 mm to 1.25 mm.

[0186] While the shaving blade 370 may be tapered or angled to a point, as a more particular feature of one embodiment of the present invention, the shaving blade 370 has a length, and the length of the undercut 404 formed in the patient's bone 402 is a function of the length of the shaving blade 370 of the hole widening element 304.

[0187] It will be appreciated that engagement of the two tapered or inclined surfaces, i.e., the distally opposing (optionally inner proximal) tapered surface 366 of the hole widening element 304 and the distally extending tapered surface 334 of the piercing element 302, can remove drilling residue into the recess 360 and act as a lubricant, thereby allowing smooth displacement of the hole widening element 304 relative to the piercing element 302.

[0188] As shown in FIGS. 12A-12D, the engravings are optionally radially extended by a bending force applied to a single surface of the arms 358 of the hole widening element 304.

[0189] Referring again to Figures 9A and 9B, in another embodiment, the hole widening element 304 shown in Figures 9A and 9B may be in a stressed or loaded state inside the drilling element 302, with the arms 358 of the hole widening element 304 under stress and at an angle to each other.

[0190] 10B, the generally proximal inward tapered surface 372 of the chisel 368 is biased against the opening 320 and extends longitudinally from the distally facing shoulder 322, preventing radial extension of the chisel 368. At this point, an initial hole 400 of a first diameter can be formed in the patient's bone 402 (FIGS. 10C and 10D).

[0191] 11 , the pusher element 308 has been partially advanced axially distally and partially inserted into the handle 306, such that its distal end engages the hole widening element 304 and displaces it axially and distally. The axial displacement of the hole widening element 304 relative to the drilling element 302 also causes the proximal inner tapered surface 372 to gradually engage and slide over the distal opposing shoulder 322. Due to its resilience and shape memory properties, the bone material removal device 300 tends to return to its original, unstressed, or resting, shape shown in FIGS. 9A and 9B when stress is released, allowing the arms 358 of the hole widening element 304 to extend radially outward through one or more apertures 320.

[0192] 12A-12D, the hole widening element 304 has been fully axially displaced relative to the piercing element 302, and the proximal inner tapered surface 372 is no longer in contact with and is no longer restricted by the distal opposing shoulder 322. At this stage, the hole widening element 304 can fully return to its original unstressed or resting shape shown in FIGS. 9A and 9B, and the arms 358 of the hole widening element 304 can fully extend radially outward through the aperture(s) 320.

[0193] Optionally, the protrusion 328 may act as a counter support to support the engraving portion 368 in an extended position, countering radial forces directed toward the center and preventing the engraving portion 368 from retracting into the drilling element 302.

[0194] Thus, as a particular feature of one embodiment of the present invention, axial movement of the hole widening element 304 relative to the protrusion 328 allows the hole widening element 304 to fully return to its original unstressed or resting shape, displacing one or more cutting edges of the arms 358 of the hole widening element 304 to a radially extended position.

[0195] Referring again to FIG. 9A, the carving portion 368 may comprise one or more carving blades 902 and 904, respectively, angled relative to one another and joined at least at one end.

[0196] The first or primary chisel blade 902 may operate to cut a major portion of the bone fragment to form a first surface of the fragment, and the second or secondary chisel blade 904 may operate to chip away the bone fragment by cutting along a second adjacent surface of the fragment.

[0197] 9A , the direction of rotation and the leading wall defined by the primary reaming blade 902, the secondary reaming blade 904, and the angle therebetween may define a rake angle 906 that provides an upwardly facing surface for removal residue (i.e., bone fragments) to rise above the end relief or clearance curved surface 921 (dashed arrow 952) or to collect in the recess 360 along the distally facing inner proximal tapered surface 366 (dashed arrow 954). Additionally, engagement of the two tapered or angled surfaces, i.e., the distally facing inner proximal tapered surface 366 of the hole widening element 304 and the distally extending tapered surface 334 of the drilling element, allows drilling residue to enter the recess 360 and act as a lubricant to smoothly displace the hole widening element 304 relative to the drilling element 302.

[0198] 13A and 13B, which are simplified cross-sectional views of another embodiment of a bone material removal device. Figure 13A shows an embodiment of a bone material removal device 1300 that is similar to the embodiment of Figure 7, except that the uncut ends 1310 of one or more arms 1302 of the hole widening element 1304 extend distally beyond one or more cuts 1306 and meet proximally, terminating in an inner proximal tapered or beveled surface 1308 of the arm 1302.

[0199] Axial movement of the hole widening element 1304 relative to the drilling element 302 engages the inner proximal tapered or inclined surface 1308 of the non-cutting end 1310 of the arm 1302 with the protrusion 328 that geometrically interferes with the axial movement of the hole widening element 1304, and causes the arm 1302 to bend and deflect, thereby causing the cutting portion 1306 to extend radially beyond the surface of the cannula and cut bone from the wall of the hole.

[0200] 13B, an embodiment of a bone material removal device 1350 similar to the embodiment of FIG. 7 differs from the embodiment of FIG. 7 in that a recess 360 is narrow proximally and wide distally and is defined by and bounded by centrally facing surfaces 1314 of arms 1302, with a locking protrusion 1352 disposed adjacent the centrally facing surfaces 1314 and / or within a distal portion of the recess 360 between two or more centrally facing surfaces 1314 of arms 1312. One or more non-carved proximal portions 1312 of arms 1302 originate from a proximal boundary of recess 360 and extend from arm 1302 to and distally bounded by carved portion 1306. Axial movement of the hole widening element 1304 biases one or more surfaces of the non-cutting proximal portion 1312 of the arm 1302 that define the recess 360 against the protrusion 1352 that geometrically interferes with the axial movement of the hole widening element 1304, and the arm 1302 bends and deflects, causing the cutting portion 1306 to extend radially beyond the surface of the cannula and cut bone from the wall of the hole.

[0201] 10B, 11, 12B, 13A, and 13B, each of the chiseled portions 364 / 1306 is radially extended by a bending force applied to a single face of one or more arms 358 / 1302 of the spreader element 304 / 1304. Also, in some embodiments, when the one or more arms 358 / 1302 are fully deflected and the one or more chiseled portions 364 / 1306 are fully radially extended, the one or more arms 358 / 1302 are generally parallel to the longitudinal axis of the device, and the chiseled portions 364 / 1306 are supported by a counter-support, such as a protrusion 328.

[0202] As shown in Figures 14A and 14B, which are simplified cross-sectional views of one embodiment of a bone material removal device 1400, the hole widening element 1402 having one or more cutting portions 1404 may be limited to radial movement only, and a pusher rod 1426 may be biased to move axially to engage the hole widening element 1402 and actuate the hole widening element 1402, which moves in a purely radial direction, thereby causing the cutting portions 1404 to extend radially beyond the surface 1406 of the bone material removal device 1400.

[0203] As shown in FIG. 14A , the bone material removal device 1400 may include a lumen 1428 in communication with the atmosphere through an opening 1408 in a wall 1410 thereof. A distal edge 1412 of the opening 1408 may be located a predetermined proximal distance from a bone drilling tip 1414, from which the opening 1408 extends in a longitudinal proximal direction. The longitudinal hole widening element 1402 may include a bone chiseling portion 1404 that may be widened generally longitudinally to define an outer chiseling 1416 or multiple chiselings 1416. The bone chiseling portion 1404 may also define a radially positioned curved surface 1418 on one side that abuts the chiseling blade 1416 and forms an end relief or clearance curve that prevents friction of the chiseling portion 1404 against the bone, thereby reducing the force (e.g., torque) required to operate the hole widening device 1400.

[0204] The longitudinal hole widening element 1402 may be elastically attached to the wall 1410 of the hole widening device 1400 by an elastic attachment that resists radial outward extension of the hole widening element 1402, applying a constant radially inward tension so that, at rest, the bone carving portion 1414 is at least partially retracted into the lumen 1420 of the bone material removal device 1400 and disposed within the edge of the opening 1408, not protruding.

[0205] One or more elongated slot-like notches 1422 may be cut across the width of the element 1402, with the lengths of the notches oriented radially from the longitudinal axis of the bone material removal device 1400. Movement of the hole widening element 1402 in the longitudinal direction may be limited only radially by a radial guide mechanism including one or more pins 1424 fixed to the wall 1410 and projecting radially inward, optionally perpendicular to and through the notches 1422. The hole widening element 1402 may also include a beveled surface 1424 along its boundary or projecting from a surface of the element 1402.

[0206] The bone material removal device 1400 may also include a pusher rod 1426 that moves axially within a lumen 1428 of the bone material removal device 1400. Optionally, a tip 1430 of the pusher rod 1426 may be beveled.

[0207] In operation, the pusher rod 1426 moves axially and the tip 1430 engages and slides along the ramp surface 1424, applying a radially outward force that acts to counteract and overcome the radially inward tension created by the resilient attachment of the hole widening element 1402 to the wall 1410, causing the hole widening element 1402 to progress in a purely radial direction and be limited by the radial guide mechanism, thereby causing the bone chiseling portion 1404 to protrude circumferentially through the opening 1408 to the fully extended bone chiseling position shown in FIG. 14B.

[0208] As the pusher rod 1426 retracts, the radially outward force applied to the inclined surface 1424 against the tension created by the elastic attachment of the hole widening element 1402 to the wall 1410 decreases, and the radially outward reaction force does not return to its resting state, urging the hole widening element 1402 radially and centrally to a retracted position within the lumen 1428, with the bone chiseling portion 1414 disposed within the edge of the opening 1408 and no longer protruding.

[0209] The carving portion 1404 may be similar in structure to the widening carving portion 368 and similarly comprises a first carving blade 902, a second carving blade 904, and an angle therebetween that may define a rake angle 906 that provides an upwardly facing surface from which removal residue (i.e., bone fragments) can rise above the end relief or clearance curved surface 921 and be collected in the bone material removal device 1400.

[0210] The first chisel blade 902 may cut through a major portion of the bone fragment to form a first surface of the fragment, and the second chisel blade 904 may chip away the bone fragment by cutting along a second adjacent surface of the fragment.

[0211] It is anticipated that many related bone removal mechanisms will be developed during the life of the patent based on this application, and the scope of the term "bone sculpting" is intended to a priori include all such new technologies.

[0212] When referring to an amount or value herein, the term "about" means "within ±15% thereof."

[0213] The terms "comprises", "comprising", "includes", "including", "has", "having" and their conjugations mean "including but not limited to".

[0214] The term "consisting of" means "including but not limited to."

[0215] The term "consisting essentially of" means that the composition, method, or structure may include other ingredients, steps, and / or components, provided that these other ingredients, steps, and / or components do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0216] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly indicates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0217] Throughout this application, embodiments of the invention may be presented with reference to a range format. It is understood that the description in range format is for convenience and simplicity only and should not be construed as an absolute limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges and individual numerical values ​​within that range. For example, a description 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 numerical values ​​within that range, such as 1, 2, 3, 4, 5, and 6. This is true regardless of the breadth of the range.

[0218] Whenever a numerical range is specified herein (e.g., "10-15," "10 to 15," or any pair of numbers connected by another range designator), it is intended to include any number (decimal or integer) within the specified range boundary, inclusive, unless the context clearly indicates otherwise. As used herein, the terms "range / ranging / ranges" between a first designated number and a second designated number and "range / ranging / ranges" from a first designated number to a second designated number ("to," "up to," "until," "through," or another range designator) are used interchangeably and include the first and second designated numbers and all decimals and integers therebetween.

[0219] Unless otherwise indicated, the numerical values ​​used herein and any numerical ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors that one of ordinary skill in the art would understand.

[0220] As used herein, the term "method" refers to manners, means, techniques, and procedures for accomplishing a given task, and includes, but is not limited to, manners, means, techniques, and procedures that are known or readily developable from known manners, means, techniques, and procedures to those skilled in the arts of chemistry, pharmacology, biology, biochemistry, and medicine.

[0221] As used herein, the term "treating" includes abrogating, substantially arresting, 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.

[0222] It will be understood that certain features of the invention, which are, for clarity, described in the context of individual embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for clarity, described in the context of a single embodiment, may also be provided separately, in any suitable subcombination, or as appropriate with any other above-described embodiment of the invention. A particular feature described in the context of various embodiments should not be considered an essential feature of that embodiment unless it would be invalid without that element.

[0223] While the present invention has been described in conjunction with specific embodiments, it will be apparent to those skilled in the art that many alterations, modifications, and variations will be apparent. Accordingly, it is intended to embrace all such alterations, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0224] All publications, patents, and patent applications mentioned herein are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. Section headings, to the extent that they are used, should not be construed as necessarily limiting.

[0225] [Related Applications] This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 144,991, filed April 9, 2015, and U.S. Provisional Patent Application No. 62 / 151,375, filed April 22, 2015, the entire contents of which are incorporated herein by reference.

Claims

1. A hollow cannula; a piercing protrusion fixed to the tip of the cannula and filling the interior of the cannula; a bore widening element movable within the cannula in an axial direction of the cannula between a first position and a second position; an interference element positioned within the hollow interior of the cannula spaced from the piercing projection; Equipped with the hole widening element has two arms, each with a bone-chisel blade facing outward from the cannula; the interference element contacts each of the two arms and is disposed between the two arms when the hole widening element is in the first position; In the first position, the bone chisel blade resides within the cannula; In the second position, the bone chisel blade projects outside the cannula. Bone material removal device.

2. The two arms form a recess. The bone material removal device according to claim 1 .

3. The distance between the two arms is narrow at the proximal end and wide at the distal end. The bone material removal device according to claim 2 .

4. The bone-carving blade is provided at the tip of each of the two arms. The bone material removal device according to claim 1 .

5. As the hole widening element moves from the first position to the second position, each of the two arms is urged outwardly of the cannula by the interference element. The bone material removal device according to claim 1 .

6. The hole widening element is integrally formed of metal. The bone material removal device according to claim 1 .

7. The cannula has an opening through which the bone-carving blade protrudes outside the cannula in the second position. The bone material removal device according to claim 1 .

8. The interference element is fixed to the side of the cannula and centrally in a cross section of the cannula. The bone material removal device according to any one of claims 1 to 7.

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