WO2013113041A1

WO2013113041A1 - Methods and devices for attaching soft tissue to bone

Info

Publication number: WO2013113041A1
Application number: PCT/US2013/023658
Authority: WO
Inventors: Charles HORRELL; Trevor Lofthouse; Paul Sand; John Avi Roop; Nicholas MOURLAS
Original assignee: Tarsus Medical Inc.
Priority date: 2012-01-29
Filing date: 2013-01-29
Publication date: 2013-08-01

Abstract

The invention disclosed is an apparatus to attach soft tissue to bone. The invention incorporates, by reference, other Tarsus Medical Inc. intellectual property and proposes a new apparatus and method for anchoring within bone. A bone anchor, provided herein, can include an anchor body having a proximal end and a distal end and having an internal diameter, where the anchor body includes two or more anchor arcs connected to an anchor base at the proximal end of the anchor body and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body.

Description

METHODS AND DEVICES FOR ATTACHING SOFT TISSUE TO BONE

Cross-Reference to Related Application

[0001] This application claims the benefit of Provisional Application No. 61/591 ,928, filed January 29, 2012, which is herein incorporated by reference in its entirety.

Field of the Invention

[0002] The various embodiments disclosed herein relate to methods and devices for attaching soft tissue to bone. More specifically, certain embodiments relate to systems and methods for anchoring suture to bone and tissue.

Background of the Invention

[0003] Myriad orthopedic and plastic surgery procedures require the anchoring or reattachment of soft tissue to bone. The clinical determinants for bone anchor selection are the type of bone at the target implant site, the type of soft tissue to be attached, the potential load on the anchor, the speed requirements of that step of the operation and the long term anchoring requirements after soft tissue healing is complete.

Brief Summary of the invention

[0004 j The invention disclosed is an apparatus to attach soft tissue to bone. The invention incorporates, by reference, other Tarsus Medical Inc. iniellectual property and proposes a new apparatus and method for anchoring within bone.

[0005] A bone anchor, provided herein, can include an anchor body having a proximal end and a distal end and having an internal diameter, where the anchor body includes two or more anchor arcs connected to an anchor base at the proximal end of the anchor bod and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body; and an anchor cap adjacent the distal end of the anchor body and slidably received in the anchor body, the anchor cap including a web cutting surface positioned adjacent an anchor web and configured such that when the anchor cap is moved toward the proximal end of the anchor body, the web cutting surface cuts the web.

[0006] The anchor cap can include an anchor cap base including a retention feature, such as a barb or an interference fit of at least a portion of the anchor cap with the internal diameter of the anchor body. [0Θ07] The bone anchor can further include a suture hole, a suture, and/or a needle.

[0008] The bone anchor can farther include a plate.

[00091 The bone anchor can be a knot-less anchor design

[0010] A bone anchor delivery system, provided herein, can include a delivery tube having a proximal end and a distal end; an anchor stem slidably received within the delivery tube, the anchor stem having a proximal end and a distal end; an anchor body having a proximal end and a distal end. the proximal end of the anchor body abutting the distal end of the delivery tube, the anchor body having two or more anchor arcs connected to an anchor base at the proximal end of the anchor body and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body; and an anchor cap adjacent the distal end of the anchor body and slidably received in the anchor body, the anchor cap comprising an anchor stem attachment portion attached to the distal end of the anchor stem and a web cutting surface positioned adjacent an anchor web and configured such that when the anchor cap is moved toward the proximal end of the anchor body, the web cutting surface cuts the web.

[0011] The anchor stem attachment portion is attached to the anchor stem via a release feature, such as a fracture notch.

[0012] The bone anchor delivery system can include a deployment tool attached to the proximal end of the anchor stem. The deployment tool can be configured to move the anchor cap toward the proximal end of the anchor body by actuating the anchor stem, using, for example, a handle configured to facilitate actuation of the anchor stem.

[0013] The bone anchor delivery system can further include a hex handle plug attached to the proximal end of the delivery tube, the hex handle plug configured to engage with the deployment tool to prevent movement of the delivery tube; and a deployment stop attached to the proximal end of the anchor stem, where the deployment stop is configured to engage with the deployment tool to facilitate actuation of the anchor stem.

[0014J A bone anchor delivery kit, provided herein, can include a bone anchor delivery system and a deployment tool is configured to move the anchor cap toward the proximai end of the anchor body by actuating the anchor stem. The bone anchor delivery system can include a delivery tube having a proximal end and a distal end; an anchor stem slidably received within the delivery tube, the anchor stem having a proximal end and a distal end; an anchor body having a proximal end and a distal end, the proximal end of the anchor body abutting the distal end of the delivery lube, the anchor body comprising two or more anchor arcs connected to an anchor base at the proximal end of the anchor body and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body; and an anchor cap adjacent the distal end of the anchor body and slidably received in the anchor body, the anchor cap comprising an anchor stem attachment portion attached to the distal end of the anchor stem and a web cutting surface positioned adjacent an anchor web and configured such that when the anchor cap is moved toward the proximal end of the anchor body, the web cutting surface cuts the web.

[0015] The kit can further include a suture, a needle, a plate, a guide wire, a bone awl, and/or a delivery handle.

[0016] A method for deploying a bone anchor into a bone, provided herein, can include delivering a bone anchor comprising an anchor body in a pre-deployed state into a hole in a bone, where the anchor body comprises two or more anchor arcs, wherein the anchor arcs are in a substantially linear shape in the pre-deployed state; and transitioning the bone anchor into a deployed state, wherein the anchor arcs form arcuate shapes within the bone in the deployed state.

[0017] The anchor arcs can be connected by anchor webs in the pre-deployed state and the transitioning step can comprise splitting the anchor webs.

[0018| The bone anchor can further include an anchor cap slidably received in the anchor body, where the anchor cap is configured to split the anchor webs when moved relative to the anchor body.

[0019] A method for attaching a tissue to bone, provided herein, can include delivering a first bone anchor having a first anchor body in a pre-deployed state into a hole in a bone, where the first anchor body includes a first plurality of anchor arcs, and where the first plurality of anchor arcs are in a substantially linear shape in the pre-deployed state; transitioning the first bone anchor into a deployed state, where the first plurality of anchor arcs form arcuate shapes within the bone in the deployed state; and attaching the tissue to the first bone anchor.

[0020] The attaching step can include suturing a tissue to the bone anchor. The attaching step can include attaching a plate to the bone anchor.

[0021] The attaching step can include delivering a second bone anchor having a second anchor body in a pre-deployed state into a hole in the bone, the second anchor body comprising a second plurality of anchor arcs, where the second plurality of anchor arcs are in a substantially linear shape in the pre-deployed state; transitioning the second bone anchor into a deployed state, where the second plurality of anchor arcs form arcuate shapes within the bone in the deployed state; and attaching the second bone anchor to the first bone anchor.

[0022] A method, provided herein, can be used to attach hard or soft tissue to bone.

[0023] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0024] FIG, I depicts bone anchors placed in the calcaneus for exemplary re- ttachment of the Achilles tendon according to some embodiments.

[0025J FIG, 2. depicts the suture path after bone anchor implantation according to some embodiments.

[0026] FIG, 3 depicts the suture path after attachment to soft tissue according to some embodiments.

[0027] FIG, 4 depicts an implanted exemplary bone anchor as attached to soft tissue according to some embodiments.

[0028J FIG, 5 depicts a deployed bone anchor according to some embodiments,

[Θ029] FIG. 6 depicts a kit containing a bone anchor delivery system according to some embodiments..

[0030] FIG. 7 depicts an exemplary bone anchor in a pre-deployed state and attached to a delivery system according to some embodiments.

[0031] FIG. 8 depicts a bone anchor delivery system with sutures and needles attached to said bone anchor according to some embodiments.

[0032] FIG. 9 depicts a cross section of a bone anchor delivery system demonstrating component routing according to some embodiments. [0033] FIG. 10 depicts a close up of an exemplary bone anchor in a pre-deployed state and attached to a delivery system according to some embodiments.

[ΘΘ34] FIG. 10a depicts a schematic of an exemplary bone anchor demonstrating size relationships according to some embodiments.

[ΘΘ35] FIG. 1 1 depicts an exemplary attachment element on the proximal end of the bone anchor delivery system according to some embodiments.

[0036] FIG. 12 depicts a guide wire placed in a bone according to some embodiments.

[0037] FIG. 13 depicts an awl guided into a bone according to some embodiments.

[0038] FIG. 14 depicts a bone anchor delivery system being loaded into a delivery handle according to some embodiments,

[0039] FIG. 15 depicts a bone anchor deployment tool attached to the proximal end of a bone anchor delivery system and a close up of the bone anchor sitting inside bone before deployment according to some embodiments.

[0040] FIG. 16 depicts clockwise rotation of the deployment tool to deploy bone anchor and a close up of exemplary bone anchor expanding within bone according to some embodiments.

[0041] FIG. 17 depicts a cross section of an exemplary bone anchor incorporating release and retention features according to some embodiments.

[0042] FIG. 18 depicts an anchor cap and anchor stem incorporating a fracture notch and barbs according to some embodiments.

[0043] FIG. 19 depicts an exemplary deployed anchor after anchor stem fracture and anchor cap retention according to some embodiments.

[0044] FIG. 20 depicts an exploded view of an exemplary knot-less anchor design according to some embodiments.

[0045] FIG. 21 depicts a schematic of an exemplary knot-less anchor design according to some embodiments.

[0046] FIGS. 22, 22A, B, C, & D depict schematics of exemplary knot-less anchor designs according to some embodiments. [0047] FIGS. 23 depicts a knot-less configurations where multiple anchors are connected by central sutures according to some embodiments.

[0048] FIG. 24 depicts an anchor interfacing with a plate to trap soft tissue according to some embodiments.

[0049] FIG. 25 depicts a second sleeve incorporated to lock suture in place according to some embodiments.

[0Θ5Θ] FIG. 26 depicts an external hook and lasso for soft tissue attachment to the anchor according to some embodiments.

[0051] FIG. 27 depicts a suture path that is through and underneath the anchor cap according to some embodiments.

[0052] FIGS. 28 & 28A depict a proximal wedge that is depressed into the suture path to lock the suture in place according to some embodiments.

[0053] FIGS. 29 & 29A depict a proximal wedge that traps all suture lines and locks in place as it abuts the anchor according to some embodiments.

Detailed Description

[0054] Various embodiments disclosed herein relate to methods and devices attaching suture to bone, such as, for example, rotator cuff repair. More specifically, various embodiments herein relate to deploying and seating an anchor within the bone. Certain implementations relate to the specific design of a bone anchor that changes from a first state to a second state through the peeling or tearing of previously joined material. Other implementations relate to systems that do not require the surgeon to tie knots in the suture to affix the soft tissue. A device that is "knotless" is a device that allows for the suture to be looped through the soft tissue and then locked in place once the anchor is deployed. That is, a 'locking" feature of the anchor as described herein is a component or mechanism that allows for first passage of the suture relative to the anchor followed by non-passage of the suture relative to the anchor after anchor seating and deployment within the bone.

[0055] Provided herein are bone anchors that can be used, for example, to attach a soft tissue to bone. FIG. 10 depicts a bone anchor 2 having a proximal end 2a and a distal end 2b in a pre-deployed state and attached to a delivery system 26 at the proximal end 2a of bone anchor 2. Bone anchor 2 includes an anchor cap 20 at distal end 2b, and an anchor body 16 at proximal end 2a.

[0Θ56] Anchor body 16 is generally tube-shaped, and includes anchor arcs 18 (shown in

FIGS. 10 and 10a in a pre-deployed state) that are connected by anchor webs 24 at the distal end and an anchor body base 16a at the proximal end (shown in FIG. 5). The anchor arcs 18 can be made of any suitable biocompatible material, such as titanium, titanium alloy (e.g., nickel- titanium), stainless steel, cobalt-chromium, or other suitable plastically deformable biocompatible material. Anchor webs 24 are configured to hold anchor arcs 18 until the webs 24 are split during deployment, and can be made from any suitable material. For example, in some embodiments, anchor webs 24 can be thin metal or a weld. In some embodiments, anchor webs can be made from an adhesive. As shown in FIG. 10a, if the anchor arcs 18 and anchor webs 24 are made from the same material, the pre-deployed anchor arcs 18 are substantially thicker in cross section than the anchor webs 24 and that the arcs 18 are designed to separate and peel along anchor webs 24 as the anchor cap 20 is pulled proximaiiy. In contrast, anchor body base 16a is configured to remain attached to and connect anchor arcs 1 8 when deployed. When in an pre-deployed state, the anchor arcs 18 held by the anchor web 24s in a substantially linear shape.

[0057] The anchor cap 20 shown in FIGS. 10 and 17 is positioned adjacent to pre- deployed anchor arcs 18. As shown in FIGS. 17 and 18, anchor cap 20 has a proximal surface 19, a distal surface 21, a base 20a, and an anchor stem attachment portion 20b. Anchor cap base 20a, having surface 19b, and anchor stem attachment portion 20b are dimensioned to be siidable within the tube shape formed by anchor body 16. .Anchor cap 20 is configured to cover the ends of anchor arcs 18 prior to deployment. The distal surface 21 of anchor cap 20 can be configured in any suitable manner. For example, distal surface 21 can be configured as a pyramidal shape as shown in FIG. 10. In some embodiments, the distal surface can be configured in other shapes, such as a dome or a flat surface (not shown). The proximal surface 19 of anchor cap 20 includes a web cutting surface 19a. As shown in FIG. 10, web cutting surface 19a is located on the proximal surface of anchor cap 20 at corners 22. Web cutting surface 19a is positioned adjacent to anchor webs 24 and is configured to split a web 24 upon deployment of anchor 2.

[0058] In some embodiments, an anchor cap 20 is configured to be retained with anchor body 16 upon deployment of the bone anchor 2. For example, as shown in FIGS. 17, 18, and 19, an anchor cap 20 can include a retention feature (e.g., a barb) 60 that attaches the anchor cap 20 to an anchor body 16 when deployed via, for example, engaging a notch 60a (FIG. 19) in anchor body 16. In some embodiments, a retention feature 60 provides anchor cap retention 20 by an interference fit with the internal diameter of the anchor body 16. [0059] FIG. 7 depicts a bone anchor 2 in a pre-deployed state and attached to a delivery system 26 having a proximal end 25 and a distal end 27. Bone anchor 2 is pictured at the distal end 27 of delivery system 26 and a deployment stop 38 is pictured at the proximal end 25.

[006 J FIG, 8 depicts a bone anchor delivery system 26 with sutures 8 and needles 14 attached to a bone anchor 2. FIG. 9 depicts a cross section of a bone anchor delivery system 26 along line C demonstrating component routing as shown in FIG. 8. Bone anchor delivery system 26 includes an anchor stem 42 having a proximal end 41, a distal end 43, and a body 42a, delivery tube 44, having a proximal end 44a and a distal end 44b, deployment stop 38, and hex handle plug 40.

[0061] The anchor stem body 42a is slidably positioned inside delivery tube 44 and hex handle plug 40, which is attached to the proximal end 44a of delivery tube 44. Distal end 43 of anchor stem 42 is configured to detachably connect to anchor cap base 20a via anchor stem attachment portion 20b. A release feature (e.g., a fracture notch or a weld) can be associated with the distal end 43 of anchor stem 42 and/or anchor stem attachment portion 20b of anchor cap 20. For example, in some embodiments, as shown in FIGS. 17 and 18, anchor stem 42 and anchor stem attachment portion 20b are formed as a continuous rod that are demarcated by a fracture notch 58. Upon deployment of bone anchor 2, the release feature can be used to detach anchor stem 42 from anchor cap 20. For example, as shown in FIG. 19, fracture notch 58 can be used to facilitate detachment of the anchor stem 42. from anchor cap 20 by pro viding a weak point that can be broken by, for example, increasing the proximal force on anchor stem 42 (via, for example, engagement of a retention feature on the anchor cap 20 with anchor body 16) or by twisting anchor stem 42.

[0062] A deployment stop 38 is attached to the anchor stem 42 near proximal end 41.

Deployment stop 38 and hex handle plug 40 are configured to engage with deployment tool 34 (shown in FIG. 15) and connect to anchor body base 16a and anchor cap 20 via anchor stem 42. When bone anchor 2 is attached to delivery system 26, the distal end 44b of delivery tube 44 abuts anchor body 16. In use, force is transmitted from deployment tool 34 to deployment stop 38 and along anchor stem 42 that connects to anchor cap 20 via anchor body base 16a to pull anchor cap 20 proximally to separate and deploy arcs 18 along anchor webs 24.

[0063] FIG. 1 1 depicts an embodiment of a deployment stop 38 on the proximal end 41 of anchor stem 42. In the upper part of FIG. 1 1 , deployment stop 38 includes a notch 46 and is attached to anchor stem 42 via a weld 48. In some embodiments, a notch 46 and weld 48 can be designed to maximize weld area along stem 42 to withstand the delivery loads imparted by the deployment tool 34. For example, the lower part of FIG. 1 1 shows the length 47 of notch 46 relative to the length 51 of the un-notched portion of the anchor stop 50. Generally, it is desirable that a deployment stop 38 be attached to anchor stem 42 in such a way that the attachment point (e.g., weld 48) has a tensile strength greater than that of stem 42. In some embodiments, a deployment stop 38 can be configured such that the notched length 47 and un-notched length 51 as a percentage of total stop length 52 are a balance between material properties of the stop 38 and the load carrying capacity of the welds 48. In some embodiments, the length of weld 48 can be adjusted relative to the cross sectional area of stem 42 such that the ratio of the length of weld 48 to the cross sectional area of stem 42 results in greater tensile strength of the weld 48 than that of stem 42.

[0064] FIG. 5 depicts an embodiment of a deployed bone anchor 2 including anchor body base 16a and anchor arcs 18 in a deployed state. After deployment, the anchor arcs 18 are still attached to anchor body base 16a, and form an arcuate shape or hook- like shape. Anchor webs 24 that have been split by the web catting surface of anchor cap 20 are attached to the sides of anchor arcs 18. In some embodiments, as shown in FIG. 17, the angle formed between anchor cap base surface 19b and anchor cap proximal surface 19 (angle D), can be adjusted to result in a desired shape for the deployed anchor arcs 18. Angle D can range from about 125° to about 170° (e.g., from about 130° to about 160°, from about 135° to about 150°, from about 125° to about 150°, from about 135° to about 170°, from about 140° to about 150°, and the like). Angle D can be adjusted to be smaller in order to increase the curvature of anchor arcs 18. Conversely, angle D can adjusted to be larger in order to reduce the curvature of anchor arcs 18.

[0065] A bone anchor can be configured to attach or retain a suture in any appropriate manner. FIGS. 10, 10A, 20, 22, 22A-D, 25, 26, 27, 28, 28A, 29, and 29A show various bone anchor configurations that facilitate suture attachment and/or retention. As shown in FIGS. 10 and 10A, in some embodiments, anchor body base 16a includes suture holes 28 in which a suture 8 can be inserted and/or attached to the anchor body base 16a. In some embodiments, a suture 8 can be retained in a suture hole 28 via one or more knots in suture 8. it is to be understood that a knot can be positioned along any location in a suture such that it retains the suture on the bone anchor 2. For example, a knot can be positioned adjacent a suture hole 28, or can connect two ends of a suture 8 to form a loop in order to retain suture 8 in suture hole 28.

[0066] In some embodiments, a suture can be attached to a bone anchor by wrapping the suture around the bone anchor. For example, FIG. 26 depicts an external hook 70 and lasso 72 for soft tissue attachment to the anchor 2. [0067] in some embodiments, a suture can be attached and/or retained to a bone anchor without a knot (i.e., a knot-less anchor design). For example, FIGS. 2.0, 21, and 22, 22.A, and 22B depict an embodiment of a knot-less anchor design, FIG. 2.0 shows an exploded view of a knot- less anchor design in which bone anchor 2 retains suture 8 without a knot. FIG. 22B shows a similar view to FIG. 20 with some elements depicted as transparent, and a cross section of suture retention flanges 62 along cross section A. Proximal to anchor cap 20 are suture retention flanges 62 that project from the anchor stem 42. Upon anchor 2 deployment, the suture retention flanges 62. translate proximally to capture suture 8 residing within the open suture path 64, FIG. 2.1 depicts a schematic of the knot-less anchor design of FIG. 20. This schematic shows the placement of the anchor 2 relative to the anchor cap 20. The retention flanges 62 (not visible in FIG. 21) reside within the un-deployed anchor arcs 18. FIGS. 22A shows potential placement of suture 8 in suture paths 64 prior to deployment. In use, a surgeon can place the suture through adjacent soft tissue prior to introducing the anchor in bone. Then the suture, attached to soft tissue, can be placed through the open suture paths 64 or tensioned within suture paths 64. Subsequent to anchor deployment, the suture 8 with then be captured and a knot-less effect shall be delivered. FIG, 22 depicts a schematic of the knot-less anchor design of FIG. 20 after anchor deployment. The suture retention flanges 62 are pulled proximally as the anchor deploys into the anchor body 16. Flanges 62 crimp on to the suture 8 residing in the open suture path 64.

[0068] FIG. 22C depicts a schematic of another embodiment of a knot-less anchor design in which suture 8 is retained to anchor body 16 with a screw 80 that can be tightened onto suture 8 by the surgeon,

[0069] FIG. 22D depicts a schematic of another embodiment of a knotless anchor design in which anchor body 16 comprises an anchor body base 16a and anchor arcs 18 as separate pieces that fit together along joint 16b. Upon deployment anchor body base 16a and anchor arcs 18 compress together in order to trap and retain suture 8 in suture holes 28.

[0070] FIG, 25 depicts another embodiment of a knot-less anchor design in which a sleeve or cap 68 coaxial to anchor body 16, Cap 68 can be used to trap suture 8 against the anchor body 16 and locks it in place so the surgeon does not have to tie a knot, in some embodiments, the anchor 2 can be deployed (upper) prior to placement of cap 68 (lower). A cap 68 can be made of any suitable material, such as, for example, polyethylene, polyether ether ketone,

[0071] FIGS. 28 and 28A depict another embodiment of a knot-less anchor design in which a proximal wedge 76 is depressed into the suture path 84 to lock suture 8 in place. [0Θ72] FIGS. 29 and 29A depict another embodiment of a knot-less anchor design in which a proximal wedge 78 traps sutures 8 and locks in place as it abuts the anchor 2. In some embodiments, proximal wedge 78 can be placed on a suture 8 when anchor 2 is in a pre-deployed state (as shown in FIG. 29) and then moved adjacent to the anchor body base 16a when anchor 2 is in a deployed state (as shown in FIG. 29A).

[0073] As shown in FIG. 27, in some embodiments, a suture path 74 can be positioned through and underneath the anchor cap 20. In this embodiment, when the anchor 2 is deployed, suture 8 is trapped between the anchor cap 20 and the anchor body 16.

[0074] In some embodiments, a structure other than a suture can be associated with a bone anchor provided herein. For example, FIG. 24 depicts an anchor interfacing with a plate 66 to trap soft tissue against bone 9. In some embodiments, piate 66 can be absorbable,

[0075] FIG. 6 depicts an embodiment of a kit 30 containing various components for delivering a bone anchor. Kit 30 includes an awl 32 designed to clear a hole in bone, a deployment tool 34 designed to retract anchor cap 20 and peel anchor 2, a delivery handle 36 designed to facilitate introduction of delivery system 26 and bone anchor 2 into a hole in bone, a guide wire 54 to facilitate alignment, a bone anchor 2, and suture 8 and a suture spool 8a. In use, the components of kit 40 are used for delivering a bone anchor into bone.

[0Θ76] A method for delivering a bone anchor into bone is provided herein. Generally, a bone anchor is placed into a hole made in bone and then the anchor is deployed as described herein. The bone anchor can then be used, for example, to attach a tissue (e.g., a soft tissue or bone) to bone.

[0077] FIG, 13 depicts an awl 32 clearing an implant hole (not visible) in bone 9. In some embodiments, a guide wire 54 is placed in the bone 9 to guide awl 32 to the desired location in the bone, as shown in FIG. 12. In some embodiments, awl 32 can be used to clear an implant hole without the use of a guide wire,

[0078] FIG. 14 depicts a bone anchor delivery system 26 being loaded into a delivery handle 36. Delivery handle 36 facilitates introduction of bone anchor 2 into bone hole 12 (shown in FIGS, 1 and 2). In some embodiments, delivery handle 36 is removed from bone anchor delivery system 26 and replaced with deployment tool 34 prior to deployment of anchor 2. FIG. 15 shows bone anchor 2 in bone 9 prior to deployment of bone anchor 2. [0079] Once bone anchor 2 is delivered into hole 12, bone anchor 2 is deployed by pulling deployment stop 38, anchor stem 42, and anchor cap 20 proximally (e.g., by rotation R of deployment tool knob 56, shown in FIG. 15) to peel anchor arcs 18. FIGS, 4 and 16 show a bone anchor 2 in a deployed state in bone 9. FIG. 2 depicts a suture 8 and needle 14 associated with bone anchor 2 after the bone anchor 2 is implanted in hole 12 in bone 9.

[0080] A bone anchor provided herein and deployed in a bone can be used to attach a soft tissue (e.g., muscle or tendon) or hard tissue (e.g., bone) to the bone. FIGS. 3 shows a soft tissue 7 being sutured to bone 9 using needles 14 and sutures 8. FIG. 4 shows a cross section of a bone 9 showing bone anchor 2. deployed in cortical bone 4 and cancellous bone. Suture 8 holds soft tissue 7 against the bone.

[0081] In some embodiments, a bone anchor provided herein can be used for reattachment of the Achilles tendon to the calcaneus. As shown in FIG. 1, a bone anchor 2 is placed in a hole 12 drilled into the calcaneus 5. Sutures 8, pre-loaded onto bone anchors 2 connect the Achilles tendon 6 to the anchor 2. Bone anchors 2 can be placed in cancellous bone 10 or cortical bone 4. It is understood device embodiments disclosed in U.S. Application 12/793,429, entitled ''Methods and Devices for Treating Hallux Valgus" and filed on June 3, 2010, which is hereby incorporated by reference in its entirety, could be used with the methods, systems, and devices disclosed herein.

[0082] In some embodiments, two or more bone anchors can be connected by a suture.

For example, FIG. 23 depicts a plurality of anchors 2 that are implanted and connected by a suture 8. In some embodiments, a suture 8 connecting a plurality of anchors is designed and implanted in a fashion to trap soft tissue and hold it in apposition to bone. In some embodiments, a suture 8 connecting two or more anchors 2 can be used to hold two bones in a fixed position relative to one another.

[0083] Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

Claims What is claimed is:

1. A bone anchor, comprising: a. an anchor body having a proximal end and a distal end and having an internal diameter, the anchor body comprising two or more anchor arcs connected to an anchor base at the proximal end of the anchor body and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body; and b, an anchor cap adjacent the distal end of the anchor body and slidably received in the anchor body, the anchor cap comprising a web cutting surface positioned adjacent an anchor web and configured such that when the anchor cap is moved toward the proximal end of the anchor body, the web cutting surface cuts the web.

2. The bone anchor of claim 1, wherein the anchor cap comprises an anchor cap base including a retention feature.

3. The bone anchor of claim 2, wherein the retention feature is a barb.

4. The bone anchor of claim 2, wherein the retention feature is an interference fit of at least a portion of the anchor cap with the internal diameter of the anchor body.

5. The bone anchor of claim 1 , farther comprising a suture hole.

6. The bone anchor of claim 1 , further comprising a suture.

7. The bone anchor of claim 1, farther comprising a needle.

8. The bone anchor of claim 6, wherein the bone anchor is a knot-less anchor design.

9. The bone anchor of claim 1, further comprising a plate.

10. A bone anchor delivery system, comprising: a. a delivery tube having a proximal end and a distal end; b. an anchor stem slidably received within the delivery tube, the anchor stem having a proximal end and a distal end; c. an anchor body having a proximal end and a distal end, the proximal end of the anchor body abutting the distal end of the delivery tube, the anchor body comprising two or more anchor arcs connected to an anchor base at the proximal end of the anchor body and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body; and d. an anchor cap adjacent the distal end of the anchor body and slidably received in the anchor body, the anchor cap comprising an anchor stem attachment portion attached to the distal end of the anchor stem and a web cutting surface positioned adjacent an anchor web and configured such that when the anchor cap is moved toward the proximal end of the anchor body, the web cutting surface cuts the web.

1 1. The bone anchor delivery system of claim 10, wherein the anchor stem attachment portion is attached to the anchor stem via a release feature.

12. The bone anchor delivery system of claim 1 1 , wherein the release feature is a tracture notch.

13. The bone anchor delivery system of claim 10, further comprising a deployment tool attached to the proximal end of the anchor stem.

14. The bone anchor delivery system of claim 13, wherein the deployment tool is configured to move the anchor cap toward the proximal end of the anchor body by actuating the anchor stem.

15. The bone anchor delivery system of claim 14, wherein the deployment tool comprises a handle configured to facilitate actuation of the anchor stem.

16. The bone anchor delivery system of claim 14, further comprising: a. a hex handle plug attached to the proximal end of the delivery tube, the hex handle plug configured to engage with the deployment tool to prevent movement of the delivery tube; and b. a deployment stop attached to the proximal end of the anchor stem, the deployment stop configured to engage with the deployment tool to facilitate actuation of the anchor stem.

17. A bone anchor delivery kit, comprising: a. a bone anchor delivery system, comprising: i. a delivery tube having a proximal end and a distal end; ii. an anchor stem slidably received within the delivery tube, the anchor stem having a proximal end and a distal end; iii. an anchor body having a proximal end and a distal end, the proximal end of the anchor body abutting the distal end of the delivery tube, the anchor body comprising two or more anchor arcs connected to an anchor base at the proximal end of the anchor body and anchor webs connecting the two or more anchor arcs at the distal end of the anchor body; and iv. an anchor cap adjacent the distal end of the anchor body and slidably received in the anchor body, the anchor cap comprising an anchor stem attachment portion attached to the distal end of the anchor stem and a web cutting surface positioned adjacent an anchor web and configured such that when the anchor cap is moved toward the proximal end of the anchor body, the web cutting surface cuts the web; and b. a deployment tool is configured to move the anchor cap toward the proximal end of the anchor body by actuating the anchor stem.

18. The kit of claim 17, further comprising a suture.

19. The kit of claim 17, further comprising a needle.

20. The kit of claim 17, further comprising a plate.

21. The kit of claim 17, further comprising a guide wire.

22. The kit of claim 17, further comprising a bone awl.

23. The kit of claim 17, further comprising a delivery handle.

24. A method for deploying a bone anchor into a bone, the method comprising: a. delivering a bone anchor comprising an anchor body in a pre-deployed state into a hole in a bone, the anchor body comprising two or more anchor arcs, wherein the anchor arcs are in a substantially linear shape in the pre-deployed state; and b. transitioning the bone anchor into a deployed state, wherein the anchor arcs form arcuate shapes within the bone in the deployed state.

25. The method of claim 24, wherein the anchor arcs are connected by anchor webs in the pre- deployed state and the transitioning step comprises splitting the anchor webs.

26. The method of claim 25, wherein the bone anchor further comprises an anchor cap slidabiy received in the anchor body, the anchor cap configured to split the anchor webs when moved relative to the anchor body.

27. A method for attaching a tissue to bone, the method comprising: a. delivering a first bone anchor comprising a first anchor body in a pre-deployed state into a hole in a bone, the first anchor body comprising a first plurality of anchor arcs, wherein the first plurality of anchor arcs are in a substantially linear shape in the pre-deployed state; b. transitioning the first bone anchor into a deployed state, wherein the first plurality of anchor arcs form arcuate shapes within the bone in the deployed state; and c. attaching the tissue to the first bone anchor.

28. The method of claim 27, wherein the attaching step includes suturing a tissue to the bone anchor.

29. The method of claim 27, wherein the attaching step includes attaching a plate to the bone anchor.

30. The method of claim 27, wherein the attaching step comprises: a. delivering a second bone anchor comprising a second anchor body in a pre- deployed state into a hole in the bone, the second anchor bod comprising a second plurality of anchor arcs, wherein the second plurality of anchor arcs are in a substantially linear shape in the pre-deployed state; b. transitioning the second bone anchor into a deployed state, wherein the second plurality of anchor arcs form arcuate shapes within the bone in the deployed state; and c. attaching the second bone anchor to the first bone anchor.

31. The method of claim 27, wherein the tissue is a soft tissue.

32. The meihod of claim 27, wherein the tissue is a hard tissue.