COMPLIANT INSERTER FOR IMPLANTS

Abstract

An improved implant inserter, and method of using same, with an elongated, substantially rigid shaft having a proximal surface which is capable of receiving a driving force, and a substantially rigid tip portion having a distal end and a proximal end. At least the distal end of the tip portion is capable of being placed within an implant such as a suture anchor. The inserter further includes a compliant region disposed between the tip portion and the shaft which requires less lateral force to bend than the tip portion, at least when the tip portion has been placed within the implant.

Claims

1-25. (canceled)

26. A method of inserting a suture anchor into bone, comprising: coupling a suture anchor, having a distal end and a proximal end, and defining a lumen open at the proximal end, to an inserter including an elongated, substantially rigid shaft having a proximal surface which is capable of receiving a driving force, a substantially rigid tip portion having a distal end and a proximal end, by placing the distal end within the lumen of the suture anchor to provide internal support for the suture anchor during insertion into bone, and abutting a distal-facing shoulder at the proximal end of the tip portion against the proximal end of the suture anchor, and wherein the inserter further comprises a compliant region disposed between the shoulder and the shaft which requires less lateral force to bend than the tip portion, at least when the tip portion has been placed within the suture anchor, the compliant region being selected from a) a material more malleable than the tip portion, b) a bellows-type structure, and c) a smaller cross-section region of the shaft; and driving the suture anchor into the bone.

27. The method of claim 26 further including maintaining sterility of the suture anchor and the inserter until the suture anchor is inserted into the bone.

28. The method of claim 26 further including forming a hole in the bone to receive the suture anchor.

29. The method of claim 26 wherein the compliant region comprises the material more malleable than the tip portion, and wherein the method further comprises the step of, prior to driving the suture anchor into the bone, bending the material more malleable the tip portion to move the shaft off axis with respect to the tip portion.

30. The method of claim 26 wherein the compliant region comprises the bellows-type structure, and wherein the method further comprises the step of, prior to driving the suture anchor into the bone, bending the bellows-type structure to move the shaft off axis with respect to the tip portion.

31. The method of claim 26 wherein the compliant region comprises the smaller cross-section region of the shaft, and wherein the method further comprises the step of, prior to driving the suture anchor into the bone, bending the smaller cross-section region of the shaft to move the shaft off axis with respect to the tip portion.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In what follows, preferred embodiments of the invention are explained in more detail with reference to the drawings, in which:

[0019] FIG. 1 is a schematic side view of an inserter according to the present invention releasably attached to a suture anchor which has been driven into bone;

[0020] FIG. 2 is an enlarged view of a portion of the inserter of FIG. 1 featuring a bellows-type compliant region;

[0021] FIG. 3 is a side view of an alternative inserter according to the present invention having a reduced-diameter neck region;

[0022] FIG. 4 shows the inserter of FIG. 3 internally supporting a suture anchor;

[0023] FIG. 5 is a schematic perspective view of yet another inserter according to the present invention having an anchor retention element;

[0024] FIG. 6 is an enlarged cross-sectional view of the inserter of FIG. 5;

[0025] FIG. 6A is an enlarged view of a portion of FIG. 6; and

[0026] FIG. 7 is a schematic cross-sectional view of an anchor retention element interacting with an internal wall of an implant.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

[0027] This invention may be accomplished by an implant inserter with an elongated, substantially rigid shaft having a proximal surface which is capable of receiving a driving force, and a substantially rigid tip portion having a distal end and a proximal end. The tip portion is capable of being placed within an implant. The inserter further includes a compliant region disposed between the tip portion and the shaft which requires less lateral force to bend than the tip portion, at least when the tip portion has been placed within the implant. The term “bend” includes elastic, plastic and irreversible deformations of the compliant region, but does not include fracture or other breakage thereof.

[0028] FIG. 1 illustrates a compliant inserter 10 according to the present invention having an elongated rigid shaft 12, a substantially rigid tip portion 14, and a compliant region 16. Shaft 12 has a proximal surface including a handle 18 to which an axial and/or rotational driving force is applied. Tip portion 14 is shown substantially within a lumen of a suture anchor 15, illustrated in phantom, that has been driven by inserter 10 into a hole or bore 17 in bone B of a patient.

[0029] Shaft 12, with centerline 26, is shown off-axis by an angle A relative to tip portion 14 and anchor 15 in hole 17, represented by bore axis 22. This orientation may be caused by an approach during insertion that is not perpendicular to the axis of the hole 17 in bone B, or by lateral force, represented by arrow 20, applied to handle 18. It is desirable to accommodate misalignment during insertion of up to thirty degrees off-axis.

[0030] Compliant region 16 is shown in greater detail in FIG. 2 in an unstressed, axially-aligned condition relative to shaft 12 and tip portion 14. Compliant region 16 serves as a flexure between shaft 12 and tip portion 14 to provide strain relief between these components, that is, it provides greater structural compliance to bending than the other components, especially the tip portion 14, at least when tip portion 14 has been placed within an implant to be inserted. In this construction, compliant region 16 is a hollow bellows 28 which includes a series of convolutions 32, 34 and 36. Inner bellows wall 30 is shown in phantom.

[0031] In some constructions, bellows 28 is a cylindrical symmetrical metal bellows such as a sylphon formed by metal spinning onto a mandrel or by hydrostatic forming within a mold. In other constructions, the compliant region is an asymmetric bellows or other structure, and includes corrugations and other variations in cross-sectional shapes to provide a region that bends or otherwise yields more readily than does the tip portion 14 of the inserter 10, at least when tip portion 14 has been placed within an implant to be inserted. Corrugations, channels or other structures may be helical, parallel or with variable skew in orientation. Corrugations and other structures may be circular, oval or polygonal cross-section, or any combination thereof. In one construction, the compliant region includes a helical spring-type element.

[0032] In certain constructions, compliant region 16 transmits torque in at least one rotational direction to enable a helically threaded anchor to be driven into bone. Anchor 15 has a hexagonal cross-sectional shape in one construction, such as disclosed by Cauldwell et al. in U.S. Patent Publication No. 2008/0147063. Suitable implant materials include those disclosed by Cauldwell et al. and in U.S. Pat. No. 7,381,213 by Lizardi, both of which are incorporated herein by reference in their entireties.

[0033] An alternative inserter 40 is shown in FIGS. 3 and 4 having a shaft 42, a compliant region 44 formed by a reduced-diameter neck, a shoulder 46, and a tip portion 48. The shoulder 46 is shown in FIG. 4 abutting the proximal end 62 of anchor 60, with tip portion 48 fully occupying a lumen within anchor 60. The proximal end of shaft 42 is not illustrated.

[0034] In this construction, all components are hollow metal cylinders with a central lumen extending therethrough, and shaft 42 has a transition region 50 which is approximately the diameter of shoulder 46. Tip portion 48 has a wall thickness of 0.006 inches and neck 44 has a length of 2 millimeters and a wall thickness the same or slightly greater than that of tip portion 48, preferably about 0.010 inches. A currently preferred material for neck 44 and tip portion 48 is stainless steel 304 annealed. A suitable material for shaft 42 is stainless steel 17-4 hardened to H900.

[0035] Although neck 44 may appear to be less bendable than tip portion 48 when inserter 40 is viewed alone as shown in FIG. 3, the relative lengths, wall thicknesses and materials of inserter 40 are selected relative to dimensions and material of a chosen implant to ensure that bending will first occur along the length of neck 44 when the implant has been combined with, that is, assembled with, the inserter 40, while still providing sufficient columnar strength to transfer enough force to drive the implant into bone. Thus, when tip portion 48 has been placed within an implant lumen, preferably substantially along its entire length, and more preferably fully placed such that shoulder 46 abuts a feature on the implant such as proximal end 62 of suture anchor 60, FIG. 4, the combination of tip portion 48 and the implant provide mutual support and reinforcement during insertion into bone.

[0036] Preferably, compliant region 44 provides a flexible bending zone and reduces the rigidity of the inserter against side loading during hammering of shaft 42 to drive anchor 60 into bone. Typical glenoid bone has a hardness of 55-D. It is desirable to have the compliant region 44 yield before the anchor or the bone become damaged. In other constructions, compliant region 44 is formed of a more malleable material, with dimensions adjusted to deliver the performance characteristics described above.

[0037] A distal portion of another inserter 70 according to the present invention is shown in FIGS. 5 and 6 having a tip portion 72 attached to a cylinder 74 with a shoulder 76. Cylinder 74 and a reduced-diameter portion 78 are shown as solid but may be cannulated in other constructions. Also, portion 78 may define an internal socket or external threads to mate with an elongated drive shaft. Portion 78 serves as a compliant region in one construction and, in another construction, a separate, more bendable element is connected to serve as the compliant region.

[0038] Tip portion 72 defines an opening 82 and faces 84, 86, 88, 90 and 92 for engaging corresponding features within the lumen of an implant. In other constructions, opening 82 is a solid face so that tip 72 defines a hexagonal shape or other polygon in cross-section.

[0039] Tip portion 72 further defines an implant retention element 100 which is shown enlarged in FIG. 6A as a projection having a smooth leading distal edge 102, a facet 104, and a sharply-defined transition 106 at a trailing edge. Similarly, FIG. 7 is a schematic cross-sectional view of a barb-like anchor retention element 112 of a tip portion 110 interacting with an internal wall 122 of an implant 120. Features 100 and 112 are examples of one or more possible additions to the distal tip portions of the inserters of FIGS. 1 and 3.

[0040] As shown in FIG. 7, barb 112 is of sufficient height to provide an interference fit against the inside wall 122 of the implant 120. Preferably, tip portion 110 and barb 112 are constructed with high stiffness in comparison to the implant 120. In response to the interference fit of the two objects, the implant 120 deforms, preferably elastically, as shown by deformation 124 in the vicinity of barb 112. A smooth lead-in, such as for leading edge 102, FIG. 6A, and leading edge 114, FIG. 7, permits releasable joining of tip portion 110 and implant 120 without skiving or plastic deformation of implant 120. Frictional reaction loading between tip portion 110 and implant 120 is increased by element 112 to minimize unintended separation. Further, the sharp transition edge 106, FIG. 6A, and edge 116, FIG. 7, “bites” into wall 122 at deformation 124 to further resist separation.

[0041] After implant 120 is fully installed into bone or other hard substrate, a user of the inserter must provide sufficient proximally-directed withdrawal force on tip portion 110 to overcome frictional resistance and any resistance to shear imparted from implant 120 onto element 112. Preferably, the withdrawal force is less than the force required to separate implant 120 from its substrate or to reduce the fixation between the implant 120 and the substrate. The geometric dimensions and tolerances of elements 100 and 112 may be tailored as desired to optimize these factors.

[0042] Thus, while there have been shown, described, and pointed out fundamental novel features of the invention as applied to a preferred embodiment thereof, it will be understood that various omissions, substitutions, and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all combinations of those elements and/or steps that perform substantially the same function, in substantially the same way, to achieve the same results be within the scope of the invention. Substitutions of elements from one described embodiment to another are also fully intended and contemplated. It is also to be understood that the drawings are not necessarily drawn to scale, but that they are merely conceptual in nature. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.

[0043] Every issued patent, pending patent application, publication, journal article, book or any other reference cited herein is each incorporated by reference in their entirety.