ALL-SUTURE SUTURE ANCHOR SYSTEMS AND METHODS

Abstract

A method of anchoring soft tissue to a suitable bone site, using a soft suture anchor, includes steps of disposing the soft suture anchor on a shaft of an inserter, and securing a proximal end of a tensioning suture limb, extending proximally from the soft suture anchor, to structure in a handle of the inserter, so that it is maintained in place at a first level of holding tension (T.sub.hold). The inserter shaft is inserted into a hone hole at a desired procedural site, so that the soft suture anchor is positioned at a location where it is to be anchored. A further step involves actuating a control mechanism in the inserter handle to move the structure proximally to apply a second level of deployment tension (T.sub.load) to the tensioning suture limb.

Claims

1. (canceled)

2. A method of manufacturing a bone anchor device, comprising: folding a first suture back and forth upon itself to create a folded section of the first suture in which a first plurality of folds face in a first direction and a second plurality of folds face in a second direction opposite the first direction, the folded section located along the first suture between a first free end of the first suture and a second free end of the first suture; moving an elongated snare device along a path through the folded section so that the first plurality of folds are located on a first side of the elongated snare device and the second plurality of folds are located on a second side of the elongated snare device opposite the first side, wherein said passing forms a separate loop between the elongated snare device and each fold in the first plurality of folds and a separate loop between the elongated snare device and each fold in the second plurality of folds; passing a first free end of a second suture through each of said separate loops; and pulling the first free end of the first suture back along the path through the folded section with the elongated snare device.

3. The method of claim 2, wherein the folded section is created in an assembly fixture.

4. The method of claim 3, wherein the first suture is folded back and forth upon itself around pins in the assembly fixture.

5. The method of claim 2, wherein the elongated snare device comprises a needle.

6. The method of claim 2, wherein the elongated snare device comprises a snare loop.

7. The method of claim 2, wherein the first suture is a size 2 suture.

8. The method of claim 2 further comprising removing a portion of the first free end of the first suture after said pulling step.

9. The method of claim 8 further comprising removing a portion of the second free end of the first suture after said pulling step.

10. The method of claim 2, wherein said moving of the elongated snare device along said path includes initially passing the elongated snare device laterally through the first suture at a first location along the first suture that is proximate the second free end of the first suture so that said pulling of the first free end of the first suture back along the path with the elongated snare device pulls the first free end of the first suture laterally back through the first suture at the first location.

11. The method of claim 2, wherein said pulling of the first free end of the first suture back along the path through the folded section causes the first free end of the first suture to be pulled laterally through the first suture multiple times.

12. The method of claim 2, wherein said pulling of the first free end of the first suture back along the path through the folded section causes the first free end of the first suture to exit the first suture a final time proximate the second free end of the first suture.

13. The method of claim 2, wherein the first suture provides an anchoring element of the bone anchor device, and wherein the second suture provides a tensioning element of the bone anchor device.

14. The method of claim 13 further comprising engaging the first suture with a leading end of a delivery shaft and having the first free end of the second suture and a second free end of the second suture extend back along the delivery shaft away from the first suture.

15. The method of claim 14, wherein the anchoring element provided by the first suture is loaded onto the leading of the delivery shaft in a folded delivery configuration.

16. A bone anchor device manufactured in accordance with claim 2.

17. The bone anchor device of claim 16, wherein the first suture provides an anchoring element of the bone anchor device, and wherein the second suture provides a tensioning element of the bone anchor device.

18. The bone anchor device of claim 17, wherein the first suture is loaded onto a leading end of a delivery shaft, and wherein the first free end of the second suture and a second free end of the second suture extend back along the delivery shaft away from the first suture.

19. The bone anchor device of claim 18, wherein the anchoring element provided by the first suture is loaded onto the leading of the delivery shaft in a folded delivery configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIGS. 1-9 are views illustrating the construction of a suture anchor according to a first embodiment, of the invention;

[0029] FIGS. 10-18 are views illustration the construction of a suture anchor according to a second embodiment of the invention;

[0030] FIG. 19 is an isometric view of a suture anchor insertion system including an inserter constructed in accordance with the principles of the invention;

[0031] FIG. 20 is an isometric view of a distal end of the inserter of FIG. 19;

[0032] FIG. 21 is a schematic cross-sectional view showing the use of the inserter system of FIGS. 19-20 and/or FIGS. 28-29 to insert a suture anchor into a bone tunnel;

[0033] FIG. 22 is a schematic top view of the handle portion of tire inserter of FIGS. 19-20 and/or FIGS. 28-29, illustrating its inner mechanical features;

[0034] FIG. 23 is a schematic side view of the handle portion shown in FIGS. 21-22;

[0035] FIGS. 24-27 are views illustrating the construction of a suture anchor according to a third embodiment of the invention; and

[0036] FIGS. 28 and 29 are schematic views illustrating an alternative embodiment of the inserter handle of the present invention, which is similar in all respects to the embodiment illustrated in FIGS. 22-23 except for the addition of an ability to adjust tension control of the inserter system.

DETAILED DESCRIPTION OF THE INVENTION

[0037] Referring now more particularly to the drawings, there is shown in FIG. 1 a suture anchor 10 comprised entirely of a suture material, as well as a floating suture 12. It should be noted, at this juncture, that the invention comprises an inserter that applies tension to the floating sutures of an all-suture anchor in order to expand it within the hone tunnel to produce an interference fit of the anchor with the walls of the bone tunnel. The construction of the anchor itself also helps to provide a strong and secure anchor point, in the bone. There are two particularly preferred methods of constructing the anchor 10 that result in a large change between the aspect ratio of the non-deployed anchor and the deployed anchor. It is desirable for the anchor 10 to be short and think for the insertion step of the procedure so that it can fit into a shallow, small diameter hole. This results in the least volume of bone removed from the patient. During deployment, the anchor 10 should expand as much as possible to provide compression against the walls of the bone tunnel, and to prevent it from pulling through the small diameter hole in the cortical bone at the tunnel entrance.

[0038] Thus, FIG. 1 illustrates a first, embodiment of a suture anchor 10 constructed in accordance with the principles of the present, invention. This embodiment is a single-loaded anchor. FIG. 2 illustrates an assembly fixture 14, wherein a piece of size 2 suture 16 (anchor suture) is wrapped around pins 18 of the fixture 14, as shown. As shown in FIG. 3, a cap 20 is placed on the fixture 14 and a needle 22 with a snare loop 24 on one end is pierced through the anchor suture 16. Then, the assembly 26 is removed from the fixture, as shown in FIG. 4.

[0039] Referring to FIG. 5, one free end of the floating suture 12 is passed back and forth through, loops 28 formed between the suture 16 and the needle 22 in the previous step. As shown in FIGS. 6 and 7, one end of the anchor suture 16 is placed in the snare loop 24 and pulled back through the suture strand.

[0040] FIG. 8 illustrates a step wherein the floating suture 12 has been pulled tight, and the ends of the anchor suture have been cut off to complete the anchor construct 10.

[0041] Now with reference to FIG. 9, a second embodiment of a suture anchor 10 constructed in accordance with the present invention is illustrated. This embodiment is a double-loaded anchor. This embodiment 10 is constructed as shown in FIGS. 10-18, FIG. 10 illustrates a first step in the method of constructing the double-loaded anchor 10 of FIG. 9, wherein a needle 22 with a snare loop 24 on the end is passed through the core of a size 2 piece of suture 16 (anchor suture). The step is repeated with a second needle 30 having a snare loop 32 being passed through a second piece of suture 16, as shown. In FIG. 11, the long end of second r anchor suture 16 is placed into the snare loop 24. The needle 22 is pulled to pull the suture end through the core of the second anchor suture 16. FIG. 12 illustrates the result of this step. Then, the long end of the first anchor suture 16 is placed in the snare loop 32 and pulled through the core of the second anchor suture 16. FIG. 13 illustrates the resulting anchor loop 33.

[0042] As shown in FIG. 14, to load the floating sutures 12, the loop 33 is placed over a suture snare 34. The anchor loop 33 is twisted in alternating directions around the suture snare 34, as shown in FIG. 15. Referring to FIG. 16, one free end of a floating suture 12 and two ends of the suture loop 33 are passed through the suture snare 34. The suture snare 34 is then pulled to pull the floating suture 12 and suture loop 33 through, the loops in the anchor.

[0043] A second floating suture end is then passed through the suture loop 33, as shown in FIG. 17. The loop is pulled in the opposite direction to pull the second floating suture through the loops in the anchor.

[0044] As represented in FIG. 18, the anchor suture ends are then trimmed to length, completing the assembly of the second embodiment of the suture anchor 10.

[0045] The two suture anchor embodiments 10 disclosed herein result in anchors that can be placed into a shallow, small diameter hole, and then when deployed by the inserter can be deployed into a large ball which is securely anchored in the bone tunnel.

[0046] Now with reference to FIGS. 19-23, the inserter 36 of the present invention will be described. The inserter 36 has two primary functions. A first function is to deliver the anchor 10 into the bone tunnel, and a second function is to apply tension on the floating sutures 12 to deploy the anchor 10. One embodiment of the inserter 36 is illustrated in FIG. 19, comprising several components required to deploy the anchor. The following describes the anchor 10 loaded with one floating suture.

[0047] Inside the inserter 36, which comprises an inner shaft 38 housed within an outer shaft 39, as well as a handle 44 disposed at a proximal end of the outer shaft 39, the floating suture ends are wrapped around a crossbar 46 (FIG. 22). Wrapping the suture around the crossbar 46 provides friction in order to tension the floating suture 12 and deploy the anchor 10. After wrapping around the crossbar 46, the suture ends pass through a hole in the crossbar 46 and are compressed between a pinching pin 48 (FIG. 23) and an inner diameter of a hole in the crossbar 46. Compressing the sutures between the crossbar hole and the pinching pin 48 provides the small holding tension required to keep the sutures from slipping around the crossbar 46. The crossbar works like a capstan used in sailing. The tension to deploy the anchor (T.sub.load) is counteracted by the sum of: 1) the friction of the suture wrapped around the crossbar, and 2) the friction of the suture compressed by the pinching pin 48 (T.sub.hold). The relationship of these opposing forces is described by Eytelwein's formula: [0048] T.sub.load=T.sub.hold e.sup.ϕμ where ϕ=total angle swept around the Crossbar [0049] μ=coefficient of friction between the suture and the crossbar materials
The design of the illustrated embodiment results in a range of T.sub.hold to achieve the desired deployment tension T.sub.load (60-150N). The sutures are wrapped two times (ϕ=720°=2π radians) around the crossbar and the coefficient of friction is determined by the suture and crossbar materials. The size and length of the pinching pin 48, as well as the hole diameter in the crossbar 46 were chosen to achieve a specific range of holding tension, T.sub.hold. The suture is pinched enough so that the minimum T.sub.hold is high enough to result, in a minimum T.sub.load of 60N and the maximum T.sub.hold is low enough to result in a maximum T.sub.load of 150N. The suture will begin to slip between the crossbar and the pinching pin when enough force is applied, keeping T.sub.load below the desired value.

[0050] Clearly, there are other methods of pinching the suture to provide the holding tension T.sub.hold, such as spring clips, suture cleats, and the like. The suture ends are then wrapped inside the handle in such a way to allow them to unwrap and pay out of the inserter smoothly as it is removed after deployment.

[0051] After the inserter tip and anchor are inserted into the bone tunnel, the anchor is deployed by turning a knob 50 on the proximal end of the inserter 36. The knob 50 has an internal screw thread 51 that engages with an external thread 51a on the proximal end of the inner shaft 38. When the knob is rotated, the inner shaft is moved proximally. The inner shaft 38 also has a cross pin 52 that prevents it from rotating within the inserter 36 and pulls the crossbar 46 along with the inner shaft 38. For the first 9 mm of travel, the inner shaft 38 tip is pulling out of the bone tunnel and out from between the two sides of the folded-over anchor. This allows the anchor to move proximally dining deployment and provides space in the bone j-tunnel for the anchor to deploy. After the inner shaft 38 moves 9 mm, the cross pin 52 contacts the crossbar 46 and begins to pull it proximally in conjunction with the inner shaft. This travel of the crossbar pulls tension on the floating sutures 12 which enlarges the anchor and causes it to compress inside the bone tunnel. The inner shaft and crossbar travel for an additional 16 mm, which results in 60-150N of tension (T.sub.load) in the floating sutures.

[0052] When the inner shaft reaches 20 mm of travel, the pinching pin 48 in the crossbar 46 contacts a smaller diameter fixed pin 54 in the handle 44 (FIG. 23). As it travels from 20 to 25 mm, the pinching pin 48 is pushed out of the crossbar to release the holding tension (T.sub.hold) on the suture ends. When, the holding tension drops to zero, the tension on the floating sutures in the anchor (T.sub.load) drops to zero and the sutures can slide and unwrap easily from the crossbar. At this point, the inserter is pulled proximally from the insertion site and the sutures unwrap and pay out of the inserter handle and deployment tube 42.

[0053] As noted above, the second anchor configuration. 10 is loaded with two floating sutures 12. In this case, two suture ends are routed up the deployment tube 42, with two limbs on either side of the inner shaft 38. One set of floating suture ends 12 are wrapped around the crossbar 46 and then routed through the handle 44 without capturing the ends with the pinching pin 48. The other set of floating sutures are wrapped around, the crossbar 46, captured by the pinching pin 48, and then, routed through the handle 44, as described previously. This allows one floating suture 12 to provide the tension required to deploy the anchor and pulls the other floating suture 12 along with the anchor 10 as it deploys. This helps to ensure proper deployment and ensures that both floating sutures 12 can slide easily within the anchor after if is deployed.

[0054] An additional feature is provided in the handle 44 to assist the practitioner. In the event that the floating suture 12 ends become tangled and caught in the handle during payout, suture access slots 56 (FIG. 23) are provided in the handle 44 to allow the practitioner to cut the suture ends with a scalpel. Tills leaves enough r length of floating suture 12 for the practitioner to complete the procedure. Reviewing FIG. 23, which is a depiction of the handle portion 44 of the inserter 36, the handle top 44a and handle bottom 44b are illustrated for clarity.

[0055] Another consideration for the design of the inserter shaft 39 is the ability to pass through a curved drill guide. In order to reach some locations (i.e. low on the glenoid rim), and to provide an angle as close to perpendicular to the surface as possible, a drill guide 58 (FIG. 21) with an approximately 25 degree curve is used. The inserter shaft 39 is flexible enough to pass through this curved guide.

[0056] The drill guide 58 is designed to work in conjunction with the inserter 36 to deploy the anchor 10. The large surface area at the distal tip of the drill guide 58 lowers the pressure exerted on the hone surface 60 during anchor deployment (FIG. 21). There are, in certain embodiments, two sizes of drill guides for the two anchor configurations, though, of course, the inventive system contemplates the usage of more than two different anchor configurations with a corresponding number of suitable drill guides. The single-loaded anchor drill guide, in one illustrative embodiment, has a tip surface area of 8.65 mm.sup.2, compared to approximately 4.25 mm.sup.2 for a typical drill guide tip, an approximate 2:1 ratio. This reduces the pressure on the bone by about one half for the same applied force and greatly reduces the risk of the tip cutting into the bone during anchor deployment or practitioner over-malleting. It also provides an opposing force over a large surface area on the bone surface, above the deploying anchor, to prevent the anchor from pulling out of the bone during tension.

[0057] Another alternative suture anchor embodiment 10 is illustrated in FIGS. 24-27. This anchor is constructed by wrapping anchor suture around a pin and tying two alternative half-hitches 62 (FIG. 25). The two limbs are then wrapped around another pin, and more half-hitches 62 are tied. The center loop 64 is wrapped around a larger pin to allow for easier loading onto the inserter inner shaft 38. The floating suture or sutures are then passed through the loops 66 (created by the pins) to complete the construct.

[0058] This anchor is constructed by forming a double loop of suture, then wrapping one of the free ends around the loop approximately twenty times. The loop is then tightened around two posts a distance apart by pulling both free ends. This creates a loop, similar to the anchor loop of the previous double-loaded anchor embodiment 10 of FIGS. 10-18. The remaining construction steps are the same as previously described—the anchor is wrapped around a snare with alternating twists and a floating suture is pulled through the openings to complete the construct.

[0059] In the foregoing described embodiments of the inserter 36, the crossbar 46 travels a fixed distance before the sutures are released, resulting in a predetermined tension range to deploy the anchor 10. If desired, however, this distance—and therefore, the deployment tension—can be adjusted by the practitioner. For example, the practitioner may be concerned about deploying in very soft or poor bone quality, and may want to deploy the anchor with a lower tension. The lower pullout force can be compensated for by implanting more anchors or further restricting the patient's post-operative activity. An embodiment of this modified design is illustrated in FIGS. 28 and 29. In this embodiment, adjustable deployment tension requires an adjustable tension control knob or switch 68 that the user can adjust as desired. In FIG. 28, the adjustable tension control 68 serves as a backstop and determines the position of the fixed pin 54. In this first position, the fixed pin 54 is in a proximal position a distance x from the control 68, which in one illustrative embodiment is approximately 12 mm, and contacts the pinching pin 48 when the crossbar 46 reaches 20 mm of travel. The pinching pin 48, and thus the deployment tension (T.sub.load) is released when the crossbar travels 25 mm, in the illustrated example. This is the high deployment tension position (the same as in the fixed embodiment described above).

[0060] However, when the adjustable tension control 68 is actuated to its second position, as shown in FIG. 29, a ramp 70 pushes the fixed pin distally, so that the fixed pin is in a distal position a distance y from the tension adjustment control 68. In the same illustrative embodiment, this distance y is approximately 14 mm. In this position, the pinching pin 48 contacts the fixed pin when the crossbar 46 reaches 18 mm of travel. The pinching pin, and thus, the deployment tension (T.sub.load), is released when the crossbar 46 travels 23 mm. This reduced travel results in a lower maximum tension (T.sub.load) applied to the floating sutures to deploy the anchor.

[0061] The tension adjustment control 68 may have two positions, as illustrated, comprising a “hard bone” position and a “soft bone” position, or if may alternatively be infinitely adjustable. The same function may be achieved with a slider or any other actuator which changes the position of the fixed pin with respect to the crossbar and the pinching pin.

[0062] In the foregoing embodiments, the maximum tension applied by the inserter is limited by the fit of the fixed pin inside the crossbar-. The floating sutures are pinched between these two components. When the tension becomes too high, the sutures will slip, placing a limit on the holding tension T.sub.hold, and thus, on the deployment tension T.sub.load. If a more precise maximum deployment force were desired, the deployment tension applied to the floating sutures could be limited by utilizing a compression spring between the cross pin and the crossbar. In such a design, when the tension in the floating sutures exceeds the force exerted by the spring at the given length, proximal movement of the cross pin would simply compress the spring and not continue to move the crossbar proximally. Because the crossbar would not move, the only additional tension applied to the floating sutures would be through the spring. By choosing the proper spring parameters (length, spring rate) and distances between the cross pin and crossbar, a maximum force may be applied to the crossbar by the cross pin (through the spring), resulting in a maximum tension applied to the suture to deploy the anchor.

[0063] In the described inserter embodiments, the suture is wrapped mound a round crossbar in order to pull considerable tension on the floating sutures. There are other methods, however, which may be used to secure the floating sutures, including spring clips, suture cleats, and the like. A pinching pin is provided to secure the suture ends. This pin is released automatically when the inner shall moves the designed distance. This pin may be replaced by a simple suture cleat on the crossbar and rely on the user to release the holding tension manually. This would require the suture ends to be accessible outside the handle.

[0064] Accordingly, although exemplary embodiments of the invention has been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from, the spirit and scope of the invention.