Method, system and apparatus for instability repair

Abstract

The present invention is entitled "Methods, systems and devices for instability repair". The present invention provides various exemplary methods, systems and devices for instability repair. Generally speaking, a surgical device is configured to drill a hole in a bone and deliver a suture anchor into the hole. In this way, a single surgical device can drill a hole and deliver an anchor into the hole to secure soft tissue to the bone. The anchor can be configured to allow the soft tissue to be secured to the bone using a suture coupled to the suture anchor without the need to knot or otherwise tie the suture to secure the soft tissue in place relative to the bone.

Description

Technical Field

[0001] The present disclosure generally relates to methods, systems, and apparatus for instability repair. Background Art

[0002] Complete or partial detachment of ligaments, tendons, and / or other soft tissues in the body from their associated bones is a relatively common injury, particularly among athletes. Such injuries are often caused by excessive stress imposed on these tissues. By way of example, tissue detachment may occur as a result of an accident, such as a fall or overexertion during work-related activities, during an athletic event, or in any of a number of other situations and / or activities.

[0003] In terms of partial detachment, if the injury is given enough time and attention is paid to make the injury no longer exposed to further excessive stress, the injury will heal itself in many cases. However, in the case of complete detachment, surgery may be required to reattach the soft tissue to one or more bones associated with it. A variety of devices can be used to reattach the soft tissue to the bone. The examples of these currently available devices include screws, staples, suture anchors and tacks. In the soft tissue reattachment surgery using screws, the separated soft tissue is usually moved back to its original position on the bone. The screw is then screwed into the bone through the soft tissue, wherein the handle and head of the screw fix the soft tissue to the bone. Similarly, in the soft tissue reattachment surgery using staples, the separated soft tissue is usually moved back to its original position on the bone. The staples are then advanced into the bone through the soft tissue, wherein the legs and bridges of the staples fix the soft tissue to the bone.

[0004] In soft tissue reattachment procedures employing suture anchors, an anchor receiving hole is typically first drilled in the bone at the desired point of tissue reattachment. The suture anchor is then deployed in the hole using a suitable tool. This effectively locks the suture to the bone, with the free end(s) of the suture extending from the bone. The free end of the suture passes through or around the soft tissue and is used to securely tie the soft tissue to the bone. Similarly, a non-knotted suture anchor may be used by first passing the suture through or around the soft tissue, then passing the suture through the suture anchor, and finally securing the construct in the bone hole. Some systems incorporate the use of a hollow guide, in which drilling and anchor placement are performed within the hollow guide.

[0005] Although current suture anchors can effectively anchor soft tissue to bone, one disadvantage of current suture anchors is that it can be difficult to locate the hole drilled in the bone after the hole is removed due to the small size of the hole and / or due to tissue and / or other substances blocking the visualization of the hole. Therefore, the surgical procedure is delayed while the surgeon attempts to find the hole. Even if the hole is located, it can be difficult to properly align the anchor at an angle to deliver it into the hole. If the anchor is not delivered into the hole at the proper angle, the anchor may break by pushing against the bone at an improper angle, and / or the anchor may damage the tissue and / or other substances near the hole by pushing against the tissue and / or other substances due to the misalignment of the anchor with the bone.

[0006] Therefore, there remains a need for improved devices, systems, and methods for instability repair. Summary of the invention

[0007] Generally speaking, methods, systems, and apparatus for instability repair are provided.

[0008] In one aspect, a surgical system is provided, which in one embodiment includes an elongated shaft having an inner cavity, an anchor, and a drill bit, the elongated shaft having an inner cavity, the anchor being configured to be implanted in a bone. The anchor has a channel extending therethrough. The drill bit is disposed within the inner cavity of the shaft, disposed within the channel of the anchor, wherein the distal end of the drill bit is located distal to the anchor, and is configured to rotate relative to the shaft and the anchor to allow a hole to be formed in the bone. The drill bit is configured to be removed from the anchor after the hole is formed by sliding the drill bit proximally within the inner cavity of the shaft and the channel of the anchor, so that the end of the drill bit is not located distal to the anchor.

[0009] The surgical system may have any number of variations. For example, the drill bit may be configured to move from an extended position to a retracted position, wherein the drill bit in the extended position may be disposed within the lumen of the shaft and within the channel of the anchor, wherein the distal tip of the drill bit is distal to the anchor and is configured to rotate relative to the shaft and anchor to allow a hole to be formed in the bone, and when the drill bit is in the retracted position, the anchor and shaft can be moved distally relative to the drill bit to insert the anchor into the hole.

[0010] In at least some embodiments, the anchor may have a slot therein that communicates with the passage, the drill bit may have a protrusion extending therefrom, and the drill bit may be configured to move relative to the anchor to align the protrusion with the slot so that the protrusion can slide within the slot when the drill bit is moved from an extended position to a retracted position. In at least some embodiments, the slot may be formed on an inner surface of the anchor that defines the passage, the protrusion may abut a distal surface of the anchor when the protrusion and the slot are not aligned, and / or the anchor may have an opening in a sidewall thereof. The opening may be in communication with the passage, the opening and the protrusion may be misaligned when the protrusion and the slot are not aligned, and the opening and the protrusion may be aligned when the protrusion and the slot are aligned.

[0011] In at least some embodiments, the surgical system may include a handle and an alignment mechanism. The handle may be at the proximal end of the shaft and may include a first alignment feature. The alignment mechanism may include a second alignment feature. The alignment mechanism may be configured to move relative to the handle to align the first alignment feature and the second alignment feature, and the alignment mechanism may be operably coupled to the drill bit so that the movement of the alignment mechanism relative to the handle also moves the drill bit relative to the handle. When the first alignment feature and the second alignment feature are not aligned, the drill bit may be prevented from moving from the extended position to the retracted position, and when the first alignment feature and the second alignment feature are aligned, the drill bit may be allowed to move from the extended position to the retracted position. In at least some embodiments, a biasing element may be disposed in the handle and configured to automatically move the drill bit from the extended position to the retracted position in response to the first alignment feature and the second alignment feature becoming aligned, and / or the anchor may have a slot formed therein, when the slot and the protrusion are not aligned, the drill bit may be prevented from moving from the extended position to the retracted position, and when the slot and the protrusion are aligned, the drill bit may be allowed to move from the extended position to the retracted position.

[0012] In at least some embodiments, the surgical system can include a biasing element configured to automatically move the drill bit from an extended position to a retracted position.

[0013] As another example, a drill bit may have a protrusion formed thereon and extending therefrom at a location proximal to the distal tip of the drill bit, and the protrusion may be configured to form a hole in a bone.

[0014] As another example, the surgical system may include a drill tip disposed on a drill bit distal to the anchor and proximal to the anchor, and the drill tip may be configured to form a hole in the bone, and the drill bit is configured to be removed from the drill tip after the hole is formed so that the drill tip is disposed in the hole distal to the anchor.

[0015] As another example, the anchor may have an opening formed therein that communicates with the passage, the drill bit may have a protrusion extending therefrom, and the drill bit may be prevented from sliding proximally within the lumen of the shaft and the passage of the anchor unless the protrusion is aligned with the opening. In at least some embodiments, the biasing element may be configured to automatically move the drill bit from the extended position to the retracted position in response to the protrusion becoming aligned with the opening.

[0016] As another example, a suture may be coupled to an anchor and releasably secured to a handle at the proximal end of the shaft.

[0017] In another embodiment, a surgical system includes an elongated shaft having a handle at its proximal end, a drill bit configured to drill a hole in a bone, and an anchor disposed on the drill bit distal to the shaft. The handle includes a first alignment feature. The drill bit is movably disposed within the shaft. The surgical system also includes an alignment mechanism movably coupled to the handle and operatively coupled to the drill bit such that movement of the alignment mechanism relative to the handle moves the drill bit relative to the shaft. The shaft and the anchor are configured to move distally as a unit to insert the anchor into the hole. When the alignment mechanism and the alignment feature are not aligned, the drill bit is prevented from moving proximally within the shaft, and when the alignment mechanism and the alignment feature are aligned, the drill bit is allowed to move proximally within the shaft.

[0018] The surgical system can be varied in any number of ways. For example, the alignment mechanism can include a rotatable knob. For example, a biasing element can be disposed in the handle, and the biasing element can be configured to automatically move the drill proximally relative to the shaft in response to the alignment mechanism and the alignment feature becoming aligned. For another example, the proximal surface of the anchor can abut the distal surface of the shaft.

[0019] In another aspect, a surgical method is provided, which in one embodiment includes drilling a hole in a bone using a drill bit disposed in a shaft of a surgical tool. The drill bit has an anchor thereon at a location proximal to a distal end of the drill bit. The method also includes adjusting an alignment mechanism at a proximal end of the shaft until the alignment mechanism is aligned with an alignment feature of a handle, thereby moving the drill bit proximally within the shaft. The method also includes advancing the shaft and anchor as a unit relative to the drill bit to move the anchor distally in the hole.

[0020] The method can be varied in any number of ways. For example, the handle can have a biasing element therein that automatically moves the drill bit proximally within the shaft in response to the alignment mechanism being aligned with an alignment feature of the handle. As another example, adjusting the alignment mechanism can cause movement of the drill bit relative to the anchor, and the alignment of the alignment mechanism with the alignment feature can direct a protrusion extending from the drill bit to align with a slot extending along the anchor, within which the protrusion slides proximally during proximal movement of the drill bit within the shaft. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present invention will be more fully understood through the following detailed description made in conjunction with the accompanying drawings, in which:

[0022] Figure 1 is a perspective view of one embodiment of a surgical device including a suture anchor coupled thereto;

[0023] Figure 2 for Figure 1 A perspective view of an anchor;

[0024] Figure 3 for Figure 1 Another perspective view of the anchor;

[0025] Figure 4 is a perspective view of one embodiment of a suture;

[0026] Figure 5 To attach to Figure 1 Anchor Figure 4 A perspective view of the suture line;

[0027] Figure 6 is a perspective view of another embodiment of a suture anchor;

[0028] Figure 7 for Figure 6 Another perspective view of the anchor;

[0029] Figure 8 To attach to Figure 6 and Figure 7 A perspective view of another embodiment of a suture anchor of the invention;

[0030] Fig. 9 for Figure 1 A perspective view of a distal portion of the device;

[0031] Fig.10 for Figure 1 Another perspective view of a distal portion of the device;

[0032] Fig.11 for Figure 1 Another perspective view of a distal portion of the device;

[0033] Fig.12 for Figure 1 Still another perspective view of a distal portion of the device;

[0034] Fig.13 for Figure 1 A partially cross-sectional, partially transparent view of a proximal portion of a device;

[0035] Fig.14 for Figure 1 A partial cross-sectional and partial transparent view of the middle portion of the device;

[0036] Fig.15 for Fig.14 part of the middle portion of

[0037] Fig.16 for Figure 1 A perspective view of the device with the drill head and its shaft moving proximally;

[0038] Fig.17 for Fig.16 Another perspective view of the device;

[0039] Fig.18 for Figure 1 a partially transparent view of another middle portion of the device;

[0040] Fig.19 for Figure 1 A distal end view of the device;

[0041] Fig. 20 is a perspective view of another embodiment of a surgical device including a suture anchor coupled thereto;

[0042] Fig.21 for Fig. 20 A perspective view of a suture anchor and a distal portion of a surgical device;

[0043] Fig. 22 for Fig.21 A cross-sectional view of a suture anchor and distal portion of a surgical device;

[0044] Fig.23 To connect surgical sutures to Fig. 20 A perspective view of a suture threading kite of a suture anchor;

[0045] Figure 24 shows the positioning relative to the bone Figure 1 A schematic diagram of a device;

[0046] Fig.25 is a schematic diagram of the device of FIG. 24 with the drill bit thereof partially bored into the bone;

[0047] Fig.26 for Fig.25 A schematic diagram of a device in which the drill bit is retracted and a hole is formed in the bone; and

[0048] Figure 27 Fig.26 Schematic diagram of the device with the anchor released therefrom and in the hole. DETAILED DESCRIPTION

[0049] Certain exemplary embodiments will now be described to understand the principles of the structure, function, manufacture and use of the devices, systems and methods disclosed herein as a whole. One or more examples of these embodiments are shown in the accompanying drawings. It will be appreciated by those skilled in the art that the devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present invention is limited only by the claims. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0050] In addition, in the present disclosure, components with the same name in each embodiment generally have similar features, so in a specific embodiment, each feature of each component with the same name is not necessarily fully set forth. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. The size and shape of the systems and devices and their components can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of the components with which the systems and devices will be used, and the methods and surgeries in which the systems and devices will be used.

[0051] The present invention provides various exemplary methods, systems and devices for instability repair. Generally speaking, a surgical device is configured to drill a hole in a bone and deliver a suture anchor into the hole. In this way, a single surgical device can drill a hole and deliver an anchor into the hole to secure soft tissue to a bone. The anchor can be configured to allow the soft tissue to be secured to the bone using a suture coupled to the suture anchor without the need to tie a knot or otherwise tie the suture to secure the soft tissue in place relative to the bone.

[0052] Using the same device to drill the hole and deliver the anchor into the hole can facilitate delivering the anchor into the hole at an appropriate angle, for example, where the longitudinal axis of the anchor is substantially coaxial with the longitudinal axis of the hole, because the same device is doing the drilling and delivery. Those skilled in the art will appreciate that the axes may not be exactly coaxial, but are considered to be substantially coaxial due to any number of factors, such as the sensitivity of the measuring equipment and manufacturing tolerances of the anchor.

[0053] Using the same device to drill the hole and deliver the anchor into the hole, rather than using one surgical device for drilling the hole and another surgical device for anchor delivery, reduces the number of instruments used in the surgical procedure, which can reduce the overall cost of the procedure and / or reduce operating room clutter. The surgical device can be configured to remain within the patient's body after the hole is drilled so that the anchor can be delivered into the hole without removing the surgical device from the patient's body, which can facilitate the anchor being delivered into the hole at the proper angle because the surgical device can be in a position relative to the hole to properly angularly align the anchor with the hole when drilling is complete.

[0054] Using the same device to drill the hole and deliver the anchor into the hole eliminates the need for the surgeon or other medical personnel to locate the hole prior to delivering the anchor into the hole, thereby saving time.

[0055] Generally speaking, the suture anchors discussed herein (also referred to herein as anchors) are configured to be implanted in a patient's body. The anchors are configured to be coupled to sutures and used in tissue repair surgeries such as arthroplasty at a joint such as a hip, knee, or shoulder, meniscus repair surgery to repair a torn meniscus at the knee, rotator cuff repair surgery to repair a rotator cuff injury at the shoulder, and the like.

[0056] The anchor may be absorbable or non-absorbable. The anchor may be made of any of a variety of materials, for example, polyetheretherketone (PEEK), polylactic acid or polylactide (PLA), Stainless steel, etc. The anchor may be formed by a variety of techniques, for example by an injection molding process such as overmolding, or by a post-molding process such as post-molding. The anchor may have any of a variety of sizes suitable for use, for example, in a particular anatomical location and for a particular patient.

[0057] Figure 1 One embodiment of a surgical device 10 is shown that is configured to drill a hole in a bone and deliver a suture anchor 12 into the hole. The anchor 12 is disposed in a Figure 2 and Figure 314 is shown as a separate element in the figure. The anchor 12 is hollow and has a passage 14 extending through it. The anchor 12 has a slot 16 extending longitudinally thereof and formed in the inner surface of the anchor 12 defining the passage 14. Therefore, the slot 16 is in communication with the passage 14. The anchor 12 has a keyhole opening 18 formed through its side wall at the distal end of the anchor 12. The opening 18 is in communication with the slot 16, and therefore with the passage 14, and is located at the distal end of the passage 14. The anchor 12 has a bone engagement feature 20 on its outer surface to help fix the anchor 12 in the bone. In the illustrated embodiment, the bone engagement feature 20 includes a plurality of barbs, each extending around a portion of the periphery of the anchor 12, but the bone engagement feature 20 may have other configurations. The anchor 12 has an interrupted perimeter at its proximal end due to a pair of opposing openings 22 formed through the sidewalls of the anchor extending distally from the proximal end of the anchor along a portion of the longitudinal length of the anchor 12. Various embodiments of suture anchors and bone engaging features thereof are further described in U.S. Pat. No. 8,114,128, entitled “Cannulated Suture Anchor,” issued Feb. 14, 2012, and U.S. Pat. No. 2009 / 0076544, entitled “Dual Thread Cannulated Suture Anchor,” filed Sept. 14, 2007, which are incorporated herein by reference in their entirety.

[0058] The anchor 12 has a suture engagement groove 26 on its exterior that extends circumferentially around the entire periphery of the anchor 12. The groove 26 is configured to place a suture therein to attach the suture to the anchor 12, thereby allowing the suture to be anchored in the bone using the anchor 12. The suture can be placed in the groove 26 by, for example, being tied around or wrapped around the anchor 12, molded to the anchor 12, sutured thereon, etc. Because the suture is located outside the drill bit 36 ​​and the anchor 12, placing the suture in the groove 26 can help protect the suture from damage during drilling. The suture placed in the groove 26 can be a tethered suture, to which one or more surgical sutures attached to the soft tissue are connected, such as by piercing the tethered suture using a suture threading kite or other means, as understood by those skilled in the art. For clarity, the anchor 12 is not shown in FIG. Figure 1 1 is shown with a suture attached thereto, but the suture may be attached to the anchor 12 and extend proximally therefrom.

[0059] In an exemplary embodiment, the suture has holes formed therein to facilitate placement of the suture within the groove 26 . Figure 4One embodiment of a suture 28 is shown having a hole 30 formed therein, which can be attached to the anchor 12 and other anchors described herein, for example, due to bifurcation of the suture 28 at a portion thereof. In the illustrated embodiment, the suture 28 is braided, which can facilitate bifurcation of the suture 28 to form the hole 30. The anchor 12 can be disposed within the hole 30 such that the portion of the suture 28 defining the perimeter of the hole 30 is disposed in the groove 26, as shown in FIG. Figure 5 Suture 28 is flexible, which may facilitate positioning of suture 28 within groove 26. A kite or other suture passing instrument may be used to facilitate attachment of suture 28 to anchor 12. In the illustrated embodiment, suture 28 is flat, but may alternatively be rounded.

[0060] Figure 6 and Figure 7 Another embodiment of the anchor 12a is shown. The construction and use of the anchor 12a is similar to Figure 1-3 The anchor 12 of the present invention is provided with a plurality of holes 14a, 16a, 18a, 20a, 26a, 27a, 28a, 30a, 36a, 37a, 38a, 39a, 40a, 41a, 42a, 43a, 44a, 46a, 47a, 48a, 49a, 50a, 51a, 52a, 53a, 54a, 56a, 57a, 58a, 59a, 60a, 61a, 62a, 63a, 64a, 66a, 67a, 68a, 69a, 70a, 71a, 72a, 73a, 74a, 76a, 77a, 78a, 79a, 80a, 81a, 82a, 83a, 84a, 85a, 86a, 87a, 88a, 89a, 90a, 91a, 92a, 93a, 94a, 95a, 96a, 97a, 98a, 99a, 100a, 101a, 102a, 103a, 104a, 105a, 106a, 107a, 108a, 109a, 110a, 111a, 112a, 113a, 114a, 115a, 116a, 117a, 118a, 119a, 120a, 121a, 122a, 123a, 124a, 125a Figure 8 One embodiment of a suture 28a is shown, with the suture 28a being attached to the anchor 12a by positioning the anchor 12a in the hole of the suture 28a, with one tail of the suture 28a being fed through the hole of the suture 28a to tighten the suture 28a around the anchor 12a, but as described herein, the suture may be attached to the anchor 12a in other ways. In the illustrated embodiment, the suture 28a is flat, but as described above, the suture 28a may alternatively be rounded. Figure 5 Unlike suture 28 of FIG. 1 , suture 28a in the illustrated embodiment does not have a hole therein.

[0061] See again Figure 1 The surgical device 10 includes an elongated shaft 32, a handle 34 at the proximal end of the shaft 34, a drill bit 36 ​​movably disposed in the shaft 32, an alignment mechanism 38 operably coupled to the drill bit 36, and a drill bit connector 40 operably coupled to the drill bit 36 ​​and configured to be releasably attached to a motor or other mechanism to rotate the drill bit 36 ​​for drilling. Figure 1 and Figure 9-12As shown, the anchor 12 is disposed at a drill bit 36 ​​distal to the shaft 32, wherein the drill bit 36 ​​extends through the channel 14 of the anchor, and the distal portion of the drill bit 36 ​​includes a distal tip 36t of the drill bit 36 ​​located distal to the anchor 12. The proximal surface abuts the distal surface of the shaft 32, wherein the distally extending opposing arms 38 of the shaft 32 are releasably seated in the opposing openings 22 of the anchor 12. The anchor 12 can be released from the drill bit 36 ​​and the shaft 32 for implantation in bone, as further described below.

[0062] The shaft 32 is an elongated member having a lumen 42 extending therethrough (see Fig. 9 ), wherein the drill bit 36 ​​is movably disposed in the inner cavity 42. Fig.13 and Fig.14 As shown, the proximal end of the shaft 32 is disposed within the handle 34. The shaft 32 has a window 32w formed in a sidewall thereof, the window 32w being configured to allow visualization of the drill bit 36 ​​therethrough, which can help provide visual confirmation that the drill bit 36 ​​has been retracted and / or that the drill bit 36 ​​is aligned relative to the anchor 12 in a position that allows the drill bit 36 ​​to be moved proximally through the anchor 12, such as by having markings on the drill bit 36 ​​visible through the window when the drill bit 36 ​​is aligned to be moved proximally through the anchor 12.

[0063] As described above, the shaft 32 has a pair of opposed arms 38 extending distally therefrom. The arms 38 are sized and shaped to be received within a pair of opposed openings 22 of the anchor by a press fit or snap fit. As further described below, when the anchor 12 is disposed in the bone hole, proximal movement of the shaft 32 releases the opposed arms 38 from the opposed openings 22 to release the shaft 32 from the anchor 12. Fig.16 and Fig.17 The shaft arms 38 are shown released from the opening 22 of the anchor. In some embodiments, the shaft 32 does not have the pair of opposing arms 38. For example, an elongated shaft without a pair of opposing arms may be used with Figure 6 and Figure 7 The invention can be used with an anchor 12a that does not have a pair of opposing openings.

[0064] The handle 34 is configured to be held by a user to facilitate manipulation of the device 10. The handle 34 may have a variety of sizes and shapes. Figure 1 , Fig.13 and Fig.14As shown, the handle 34 has a suture engagement feature 44 configured to releasably engage a suture attached to the anchor 12. The suture attached to the anchor 12 and extending proximally from the anchor 12 can have each of its tails engaged by the suture engagement feature 44. In the illustrated embodiment, the suture engagement feature 44 includes a pair of slits on each side of the handle 34 to allow each of the two tails of the suture to be secured in one of the pair of slits. The suture engagement feature 44 can have other configurations, such as a single slit, one slit on each side of the handle, a protrusion configured to have a suture wrapped around it or tied around it, a clamp, etc.

[0065] like Figure 13-15 As shown, the handle 34 is hollow and has a lumen 46 extending therethrough. The lumen 46 is sized and shaped so that various components of the device 10 are at least partially disposed therein. The proximal end of the shaft 32 is disposed within the lumen 46 at a fixed position relative to the handle 34. The drill bit 36 ​​extends at least partially through the lumen 46 of the handle. The proximal end of the drill bit 36 ​​can be disposed within the lumen 46, in which case the connector 40 can be inserted into the lumen 46 through the proximal opening of the lumen in the proximal end of the handle to operably engage the drill bit 36 ​​for drilling. Alternatively, the proximal end of the drill bit 36 ​​can be located proximal to the handle 46, in which case the connector 40 can be inserted into the proximal end of the drill bit and then inserted into the lumen 46 through the proximal opening of the lumen in the proximal end of the handle.

[0066] The distal portion of the alignment mechanism 38 is disposed within the lumen 46 of the handle. The lumen 46 has an enlarged portion 46e in which a corresponding enlarged portion 38e of the alignment mechanism 38 is disposed to help non-releasably secure the handle 34 and the alignment mechanism 38 and facilitate smooth rotation of the alignment mechanism 38 relative to the handle 34 about the longitudinal axis A of the handle 34 when the shaft 32, drill bit 34, alignment mechanism 38, anchor 12 and connector 40 are as shown. Figure 1 When assembled together as shown, the longitudinal axis A is also their longitudinal axis. Figure 1 and Fig.18 As shown, the handle 34 includes an alignment feature 48 that is configured to selectively align with a corresponding alignment feature 50 of the alignment mechanism 38. The alignment feature 48 of the handle is a protrusion, and the alignment feature 50 of the alignment mechanism is a recess, but the alignment features 48, 50 can each have other configurations that are the same or different from each other, such as surface markings (e.g., symbols, lines, dots, letters, numbers, arrows, etc.), colored areas that are different colors from the surrounding material (e.g., the colored area on the handle 34 is a different color from the rest of the handle 34, etc.), etc. The alignment features 48, 50 are Figure 1 and Fig.18The alignment mechanism 38 is configured to rotate relative to the handle 34 to allow the alignment features 48, 50 to move from misaligned to aligned, as further described below.

[0067] The drill bit 36 ​​includes an elongated shaft 54 ​​having a distal tip 36t at its distal end. The distal tip 36t is configured to penetrate into the bone to provide a stable position for the drill bit 36 ​​to begin drilling the bone. The tip shape of the distal tip 36t facilitates such penetration. The drill bit 36 ​​is configured to rotate about the longitudinal axis A relative to the anchor 12, the shaft 32, the handle 34, and the alignment mechanism 38 to allow the drill bit 36 ​​to use its protrusion 52 to drill a material such as bone.

[0068] like Figure 9-12 , Fig.16 , Fig.17 and Fig.19 As shown, the drill bit 36 ​​has a protrusion 52 located proximal to the distal end 36t. The protrusion 52 extends radially outward from the elongated shaft 54 ​​of the drill bit. The protrusion 52 is located distal to the anchor 12. The surface of the protrusion 52, such as its distal surface and / or its edge, is sharp or otherwise configured as a cutting surface to cut into the bone and form a hole in the bone. Therefore, the size and shape of the protrusion 52 define the size and shape of the bone hole. The size and shape of the protrusion 52 are set to slide into the keyhole opening 18 of the anchor 12 and slide within the slot 16 of the anchor 12. Therefore, the protrusion 52 is configured as a key that can enter the keyhole opening 18. The proximal end of the protrusion 52 is rounded, which can facilitate smooth entry of the protrusion 52 into the keyhole opening 18, but other shapes of the protrusion 52 are possible. The protrusion 52 is sized such that when the protrusion 52 is not aligned with the keyhole opening 18, the protrusion 52 is configured to abut the distal surface of the anchor 12, thereby preventing the drill bit 36 ​​from moving proximally. Thus, the protrusion 52 is configured as a stop member that is configured to block proximal movement of the drill bit 34 beyond a certain stop point, such as the point at which the protrusion 52 abuts the anchor 12. When the protrusion 52 is aligned with the keyhole opening 18, as shown in FIG. Figure 9-12 As shown, the keyhole opening 22 allows the protrusion 52 to enter the anchor 12 and allows the drill bit 36 ​​to move proximally beyond the stop point, as shown in FIG. Fig.16 and Fig.17 The drill bit 36 ​​can be moved proximally beyond its Fig.16 and Fig.17 to allow the distal tip 36t to exit the anchor 12 through the proximal end of the anchor.

[0069] The drill bit 36 ​​is movable from an extended position to a retracted position. In the extended position, the drill bit 36 ​​is disposed within the lumen 42 of the shaft 32, within the channel 14 of the anchor 12, with the distal tip 36t of the drill bit located distal to the anchor 12, having a protrusion 52 located distal to the anchor 12, and configured to rotate about the longitudinal axis A. Figure 1 , Figure 9-15 and Fig.19 , the drill bit 36 ​​is shown in an extended position. In the retracted position, the drill bit 36 ​​is not disposed within the channel 14 of the anchor 12. The drill bit 36 ​​in the retracted position allows the anchor 12 to be implanted in the bone, as further described below.

[0070] like Figure 13-15 1 , the device 10 includes a biasing element 56 configured to facilitate movement of the drill bit 36 ​​from the extended position to the retracted position. In the illustrated embodiment, the biasing element 56 is a coil spring, but may have other configurations, such as another type of spring, a rubber band or other elastic element, etc. The biasing element 56 is disposed within the housing 34, coiled around the drill bit 36, has a proximal end attached to the proximal support member 58, and has a distal end attached to the distal support member 60. When the drill bit 36 ​​is in the extended position, the biasing element 56 is compressed. The biasing element 56 can move from compressed to uncompressed, thereby retracting the drill bit 36, for example, moving proximally, and moving from the extended position to the retracted position.

[0071] The device 10 includes a lock 62 configured to be actuated to move the biasing element 56 from the compressed configuration to the uncompressed configuration, and thereby allow the drill bit 36 ​​to move from the extended position to the retracted position. Figure 13-15As shown, the flange 64 of the lock 62 engages the proximal surface of the proximal support member 58 to maintain the biasing element 56 in the compressed configuration. In the unlocked position, the flange 64 of the lock 62 is released from engagement with the proximal support member 58, thereby releasing the biasing element 56 and allowing the biasing element 56 to be deployed within the lumen 46 of the handle, and thus the proximal support member 58 is pushed or slid proximally within the lumen 46 of the handle. The proximal support member 58 is attached to the drill bit 36 ​​so that the proximal movement of the proximal support member causes the drill bit 36 ​​to move proximally, thereby retracting the drill bit 36. In the unlocked position, the flange 64 will abut against one side of the proximal support member 58, thereby preventing the flange 64 from re-compressing the biasing element 56 and thus preventing distal movement of the drill bit 36. In the exemplary embodiment, in the unlocked position, as a safety feature, the flange 64 engages the distal surface of the proximal support member 58, thereby preventing the biasing element 56 from being recompressed and thus preventing distal movement of the drill bit 36. The lock 62 is configured to automatically move from the initial position to the unlocked position in response to the drill bit 36 ​​drilling and pushing downward (distalward). The device 10 includes a second biasing element 70 attached to the handle 34 and the lock 62 to facilitate the pivoting of the lock 62. In the illustrated embodiment, the second biasing element 70 is a torsion spring, but may have other configurations as described above with respect to the biasing element 56.

[0072] The drill bit 36 ​​cannot be moved from the extended position to the retracted position unless the protrusion 52 of the drill bit is aligned with the opening 18 of the anchor to allow the protrusion 52 to enter and slide with the slot 16 of the anchor before exiting the anchor 12. As described above, if the protrusion 52 is not aligned with the opening 18 of the anchor, the protrusion 52 abuts against the distal surface of the anchor, thereby preventing retraction of the drill bit 36. Therefore, if the lock 62 is actuated with the protrusion 52 not aligned with the opening 18, the drill bit 36 ​​will not retract. Due to the spatial constraints and / or position of the anchor 12 and the drill bit 36 ​​within the patient's body, it may be difficult to see the protrusion 52 and / or the opening 18 when disposed within the patient's body, and therefore it may be difficult to align the protrusion 52 and the opening 18 by viewing the protrusion and the opening 18. The alignment mechanism 38 is configured to facilitate alignment of the protrusion 52 with the opening 18 of the anchor so as to enable retraction of the drill bit 36 ​​even when the protrusion 52 and / or the opening 18 are not visible to the user.

[0073] The alignment mechanism 38 is configured to move the position of the drill bit 36 ​​relative to the anchor 12, and thus move the protrusion 52 relative to the anchor 12. As described above, the alignment mechanism 38 is configured to rotate relative to the handle 34. The alignment mechanism 38 includes a knob 70 to facilitate manipulation of the alignment mechanism 38 for rotation. The alignment mechanism 38 can be rotated relative to the handle 34 to align the alignment features 48, 50. Alignment of the alignment feature 50 of the alignment mechanism with the alignment feature 48 of the handle indicates that the protrusion 52 is aligned with the opening 18. Similarly, misalignment of the alignment feature 50 of the alignment mechanism with the alignment feature 48 of the handle indicates that the protrusion 52 is misaligned with the opening 18. Therefore, when it is necessary to retract the drill bit 36, the alignment features 48, 50 can be aligned, thereby indicating that the drill bit 36 ​​is positioned relative to the anchor 12 to allow the drill bit 36 ​​to move proximally through the anchor 12, wherein the protrusion 52 slides within the slot 62 of the anchor in response to actuation of the lock 16.

[0074] Figure 20-22 Another embodiment of a surgical device 100 is shown, which is configured to drill a hole in a bone and deliver a suture anchor 102 into the hole. The construction and use of the device 100 is generally similar to Figure 1 The device 10 includes an elongated shaft 104, a handle 106 at the proximal end of the shaft 104, a drill bit 108 movably disposed in the shaft 104, and a drill bit connector 110 operably coupled to the drill bit 108 and configured to be releasably attached to a motor or other mechanism to rotate the drill bit 108 to perform drilling. Figure 1 Unlike the drill bit 36 ​​in the embodiment shown, which has a protrusion 52 thereon that is configured to cut bone, in the illustrated embodiment, the drill bit 108 does not have a protrusion thereon that is configured to cut bone. Fig.21 and Fig. 22 Best shown in Figure 20-22 The drill bit 108 of the embodiment of the present invention has a drill tip 112 configured to cut bone removably disposed thereon. The drill tip 112 is disposed on the drill bit 108 at a position distal to the anchor 102 disposed on the drill bit 108 and proximal to the distal tip 108t of the drill bit 108, which is configured to penetrate the bone to provide a stable position for the drill bit 108 to start drilling the bone. The anchor 102 is configured to push the drill tip 112 from the drill bit 108 into the drilled bone hole when the anchor 102 is pushed away from the drill bit 108 and inserted into the bone hole. Therefore, the drill tip 112 is configured to be implanted in the patient's body.

[0075] The drill tip 112 may be absorbable or non-absorbable and may be made of a variety of materials such as PEEK, PLA, The drill tip 112 may be made of any of stainless steel, stainless steel, etc. The absorbable drill tip 112 allows for unstable repairs without leaving material in the patient's body that cannot be removed without further surgical intervention. The non-absorbable drill tip 112 may allow for more effective cutting because non-absorbable materials can generally cut bone more effectively than absorbable materials. The drill tip 112 may be a composite member including both absorbable and non-absorbable materials, such that a portion of the drill tip 112 is configured to be bioabsorbable. As an example, the edge 112e of the drill tip 112 may be a non-absorbable metal to facilitate cutting, and the remainder of the drill tip may be absorbable.

[0076] The construction and use of anchor 102 is generally similar to Figure 1 The anchor 102 has a channel 114 extending therethrough, a bone engagement 116 on its outer surface, and a suture engagement channel feature 118 extending circumferentially around the entire periphery of the anchor 102 on its exterior. Figure 1 The anchors 12 are different, Figure 20-22 The anchor 102 does not have a slot or keyhole opening because the drill bit 108 does not have a keyhole opening similar to the Figure 1 Thus, the surgical device 100 does not include an alignment mechanism or alignment feature because the drill bit 108 does not need to be aligned in a particular rotational orientation relative to the anchor 102 to pull the anchor 102 outwardly proximally.

[0077] In the illustrated embodiment, the anchor 102 and the drill end 112 are disposed on the drill bit 108 with a gap 120 therebetween, which can help protect the anchor 102 during drilling of the bone. In other embodiments, the anchor 102 and the drill end 112 can be disposed on the drill bit 108 without a gap therebetween.

[0078] The anchor 102 is disposed on the drill bit 108 with a gap 122 between the anchor 102 and the shaft 104, which can help prevent premature distal movement of the anchor 102 along the drill bit 108. The device 100 includes a reduced diameter shaft extension 124 extending distally from the shaft 104 and disposed within the enlarged diameter proximal portion 118a of the lumen 114 of the anchor 102. The reduced diameter shaft extension 124 is configured to facilitate insertion of the anchor 102 into a drilled bone hole by pushing the anchor 102 from within the anchor 102, wherein the distal surface of the reduced diameter shaft extension 124 abuts the inner proximal surface of the anchor 102, as shown. Fig. 22 shown.

[0079] Fig.23One embodiment of a tether suture 126 disposed in the groove 118 of the anchor 102 and a suture threading kite 128 for threading a surgical suture 130 through the tether suture 126 is shown. In the illustrated embodiment, the tether suture 126 is flat.

[0080] 24-27 illustrate one embodiment of a method of drilling a hole in a bone and delivering a suture anchor into the hole. Figure 1 The device 10 is described with reference to FIG. 1 , but other devices described herein may be similarly used.

[0081] As shown in FIG. 24 , the distal portion of the device 10 is advanced into the patient's body. Figure 1 The device 10 is shown in a configuration in which the distal portion of the device can be advanced into the patient's body, but as described above, sutures are also present and the connector 40 may not yet be coupled to the drill bit 36. Similarly, Fig. 20 The device 100 is shown in a configuration in which the distal portion of the device may be advanced into the body of a patient, but as described above, sutures are also present and the connector 110 may not yet be coupled to the drill bit 108 .

[0082] With the distal portion of the device in the patient's body, the drill bit 36 ​​is in the extended position and the distal tip 36t is positioned relative to the bone 72 in which the anchor 12 is desired to be implanted. The connector 40 is then coupled to the drill bit 36, if not already coupled. The drill bit 36 ​​then drills a hole 74 in the bone 72, such as Fig.25 As shown. The cutting surface of the protrusion 52 cuts into the bone 72 and forms the hole 74. In this way, the protrusion 52 cuts the bone 62 to form the hole 74, wherein the distal end 36t of the drill bit 36 ​​is used to penetrate the bone 62 to begin forming the hole 74 and to help hold the drill bit 36 ​​in place before and during the initial rotation of the drill bit 36. In the embodiment of the present invention, the drill bit does not have a protrusion configured to cut bone but instead includes a releasable drill bit end such as a protrusion having a protrusion configured to cut bone. Figure 20-22 In embodiments of the drill bit 108 and the releasable drill tip 112, the drill tip cuts bone.

[0083] In the case where the device 10 is used to form a hole 74 in a bone 72, the device 10 can be used to insert the anchor 12 into the hole 74. First, the drill bit 36 ​​is moved from the extended position to the retracted position. If the alignment features 48, 50 are not aligned, thereby indicating that the protrusion 52 of the drill bit is not aligned with the opening 18 of the anchor, the alignment mechanism 38 is rotated until the alignment features 48, 50 are aligned, thereby indicating that the protrusion 52 of the drill bit is aligned with the opening 18 of the anchor, and the drill bit 36 ​​is in a position where the drill bit 36 ​​can be retracted. The lock 62 is actuated by drilling through the connector 40, thereby causing the biasing element 56 to compress within the handle 34 and once the drilling is completed, the drill bit 36 ​​is moved proximally relative to the anchor 12, the shaft 32 and the handle 34. After drilling, the connector 40 is removed from the drill bit 36.

[0084] With the drill bit 36 ​​in the retracted position, as shown Fig.26 As shown, the anchor 12 can be inserted into the hole 74. In an exemplary embodiment, the drill bit 36 ​​and the anchor 12 are aligned before the anchor 12 is inserted into the hole 74, because inserting the anchor into the hole 74 can deform the anchor 12, making alignment more difficult. The proximal surface of the handle 34 can then be used as a hammer surface on which a hammer can be struck to push the device 10 distally relative to the bone 72, thereby moving the anchor 12 into the hole 64. However, as will be appreciated by those skilled in the art, it is not necessary to use a hammer to push the anchor 12 into the hole 64, but rather another type of tool to manually push or strike the device 10. The bone engaging feature 20 of the anchor 12 (shown in Figure 2 for clarity) is shown in Figure 24. Fig.26 27 ) will engage the bone 72 to help retain the anchor 12 within the bone hole 64. With the anchor 12 inserted into the hole 64, as shown in FIG. 27 , the shaft 32 is moved proximally to disengage from the anchor 12. The device 10 can then be removed from the patient's body with the anchor 12 released from the device 10. After the anchor 12 is inserted into the hole 74, the suture attached to the anchor 12 is disengaged from the suture engagement feature 44 of the device before or after the device 10 is removed from the patient's body. In a case including a releasable drill tip such as Figure 20-22 In an embodiment of the drill tip 112, the drill tip is disposed in a bone hole that is distal to an anchor implanted in the bone hole.

[0085] Those skilled in the art will appreciate that the present invention has application in conventional minimally invasive and open surgical instrumentation, as well as in robotic-assisted surgery.

[0086] According to the above-described embodiments, those skilled in the art will recognize the additional features and advantages of the present invention. Therefore, the present invention should not be limited by the content specifically shown and described, unless the attached claims indicate otherwise. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. A surgical system comprising: an elongated shaft having an inner lumen; an anchor configured to be implanted in a bone, the anchor having a passage extending therethrough; and a drill bit configured to move from an extended position to a retracted position, the drill bit in the extended position being disposed within the lumen of the shaft and within the passageway of the anchor, wherein a distal tip of the drill bit is positioned distal to the anchor, and the drill bit is configured to rotate relative to the shaft and the anchor to allow a hole to be formed in the bone, and the drill bit is configured to be removed from the anchor after the hole is formed by sliding the drill bit proximally within the lumen of the shaft and the passageway of the anchor such that the tip of the drill bit is not distal to the anchor, and when the drill bit is in the retracted position, the anchor and the shaft are movable distally relative to the drill bit to insert the anchor into the hole; wherein the anchor has a slot therein in communication with the passage; and The drill bit has a protrusion extending therefrom, and the drill bit is configured to move relative to the anchor to align the protrusion with the slot so that the protrusion can slide within the slot when the drill bit is moved from the extended position to the retracted position. 2 . The system of claim 1 , wherein the slot is formed in an inner surface of the anchor defining the channel.

3. The system of claim 1, wherein the protrusion abuts a distal surface of the anchor when the protrusion and the slot are not aligned.

4. The system of claim 1 , wherein the anchor has an opening in a side wall thereof, the opening communicating with the channel, the opening and the protrusion being misaligned when the protrusion and the slot are not aligned, and the opening and the protrusion being aligned when the protrusion and the slot are aligned.

5. The system of claim 1 , further comprising a handle at the proximal end of the shaft, the handle comprising a first alignment feature; and an alignment mechanism including a second alignment feature, the alignment mechanism being configured to move relative to the shank to align the first alignment feature with the second alignment feature, the alignment mechanism being operatively coupled to the drill bit such that movement of the alignment mechanism relative to the shank also moves the drill bit relative to the shank; in, The drill bit is prevented from moving from the extended position to the retracted position when the first alignment feature and the second alignment feature are not aligned, and the drill bit is allowed to move from the extended position to the retracted position when the first alignment feature and the second alignment feature are aligned.

6. The system of claim 5, wherein the anchor has a slot formed therein; preventing the drill bit from moving from the extended position to the retracted position when the slot and the protrusion are not aligned; and When the slot and protrusion are aligned, the drill bit is permitted to move from the extended position to the retracted position.

7. The system of claim 5, further comprising a biasing element disposed in the shank and configured to automatically move the drill bit from the extended position to the retracted position in response to the first alignment feature and the second alignment feature becoming aligned.

8. The system of claim 1, wherein the drill bit has a protrusion formed thereon and extending therefrom at a location proximal to the distal tip of the drill bit, the protrusion being configured to form the hole in the bone.

9. The system of claim 1, further comprising a drill tip disposed on the drill bit distal to the anchor and proximal to the anchor, the drill tip being configured to form the hole in the bone, and the drill bit being configured to be removed from the drill tip after the hole is formed so that the drill tip is disposed in the hole distal to the anchor.

10. The system of claim 1 wherein the anchor has an opening formed therein communicating with the passageway, the drill bit having a protrusion extending therefrom configured to form the hole, and the drill bit is prevented from sliding proximally within the lumen of the shaft and the passageway of the anchor unless the protrusion is aligned with the opening.

11. The system of claim 1 further comprising a suture coupled to the anchor and releasably secured to a handle at a proximal end of the shaft.

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