Soft Tissue Fixation Using A Looped Suture Construct
A looped suture construct is formed by looping a suture on itself and slidably connecting the suture through an anchoring structure such that a looped end and a free end of the suture are on opposite sides of the slidable connection. The anchoring structure may be bone, a suture anchor, or another structure securely attached to bone. The looped end and the free end are passed through the soft tissue to be repaired. The free end is then passed through the looped end. Tension is applied to the free end to draw the soft tissue into contact with the desired bone, whereupon the free end is secured to maintain the tension. The looped suture end remains open and positioned on one side or surface of the soft tissue. Suture anchors of the invention are pre-loaded with at least one suture having a looped end and at least one free end.
This claims the benefit of U.S. Provisional Application No. 61/318,344, filed Mar. 28, 2010, the entire disclosure of which is incorporated by reference herein.
FIELD OF THE INVENTIONThe invention relates to surgical fixation of soft tissue. More particularly, the invention relates to methods and apparatus for soft tissue repair using a looped suture construct.
BACKGROUND OF THE INVENTIONSoft tissues, such as, for example, tendons, ligaments, muscles, and the like, are attached to bone throughout the human body. Various injuries and conditions may result in soft tissue separating or tearing away from bone. When this occurs, surgery is required to mechanically reattach the soft tissue to bone to allow the soft tissue to naturally reattach itself to the bone. Surgical repair of soft tissue typically involves passing one or more strands of suture through the soft tissue, applying tension to the suture strands to draw the soft tissue into contact with the bone, and then securing the one or more suture strands ultimately to bone usually via one or more devices implanted in the bone to complete the repair.
A major source of failure of such surgical repairs occurs at the tissue-suture interface and is known as “suture pull-through.” That is, one or more strands of suture may pull through the soft tissue. This can occur because a significant amount of tension is usually applied to the sutures to draw the soft tissue into contact with the bone, and because the individual suture strands, which are strong relative to the soft tissue, typically engage the tissue for only a short length. Suture pull-through is even more likely to occur when the suture strands run parallel to the soft tissue fibers. When pull-through occurs, the repair fails because the soft tissue is either no longer attached to the bone or not in sufficient contact with the bone to promote healing.
SUMMARY OF THE INVENTIONSoft tissue fixation according to the invention includes the passing of at least one suture through the tissue to be repaired. The passed suture is either preferably already in the form of a loop, or a loop is formed after the suture is passed through the soft tissue. The looped suture remains open and positioned on one side or surface of the soft tissue such that it is able to grab a large surface portion of the tissue in the loop. This improves the suture's grip on the tissue and decreases the likelihood that the suture will pull through the tissue, thus increasing the likelihood of surgical success.
In one embodiment of the invention, a suture is looped on itself yielding a looped end and at least one free end. The looped end is passed through a soft tissue to be repaired. The at least one free end is slidably connected through an anchoring structure. Such a structure may be a bone or suture anchor (referred to hereinafter as a suture anchor). The at least one free end is then passed through the soft tissue adjacent the looped end and then through the looped end, creating a grasping-type stitch, which also may be referred to as a cinch or loop-type stitch. Tension is applied to the at least one free end to pull the soft tissue into contact with the bone. The looped end remains open, grasping a large portion of the soft tissue surface opposite the bone. The at least one free end is then fastened ultimately to bone to maintain the tension, forming a looped suture construct that completes the repair.
In another embodiment of the invention, a suture anchor is pre-loaded with at least one looped suture, the looped suture having a looped end and one or two free ends. Pre-loaded suture anchors (i.e., suture anchors threaded with suture prior to implantation in bone) save the surgeon valuable time in the operating room. In those embodiments with one free end of suture, the original two free ends may be temporarily or permanently attached to each other to form the single free end, which in some instances may facilitate the surgical repair procedure. In other embodiments, one of the original two free ends may be tied off to the suture anchor, leaving one free end and one looped end for completing the looped suture construct. And in still other embodiments, the looped end may be formed by attaching one of the original free ends back on the suture itself and then slidably connecting the remaining free end through the suture anchor, leaving a looped end and a free end. Suture anchors of the invention may be pre-loaded with from one to six looped sutures.
The above and other advantages of the invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
The invention relates to apparatus and methods of fixing soft tissue to bone that improve the tissue-grasping strength of the suture and thus the likelihood of surgical success. In particular, by forming a looped suture construct in accordance with the invention, a larger surface area of soft tissue can be grabbed by the suture, which decreases the chance of suture pull-through.
Suture strands 106a-d are each individually passed through tendon 108 with a specialized handheld surgical tool known variously as, for example, a sharp grasper, suture passer, tissue penetrator, passer instrument, or suture passing instrument. A wide variety of such specialized tools capable of passing suture through soft tissue are known, and each tool usually includes a handle, a tissue-grasping component (e.g., tongs), and a needle to pass the suture through the tissue. After suture strands 106a-d are passed through the soft tissue, tension is applied to the strands to pull tendon 108 into contact with bone 104, as shown in
One of the disadvantages of this suture construct is that one or both of suture sections 106a,b or 106c,d may pull through tendon 108 (particularly if they run parallel to the tendon fibers), because each section is likely under significant tension and each section engages topside tendon surface 109 for only a short length. An ideal rotator cuff repair should have a strong tissue grip that minimizes the formation of gaps between the tendon and bone and that maintains mechanical stability until healing occurs. Accordingly, even a partial suture pull-through may cause the repair to fail.
As shown in
As shown in
Note that other fastening techniques and configurations (including knotless fixation) of free ends 206y and 206z are possible. For example, in other embodiments of the invention, only one of free ends 206y and 206z is passed through tendon 208 and looped end 206x. The other free end may be tied off to the anchor or passed around the end of tendon 208 and fastened to the free end pulled tight through looped end 206x, as shown in
In another embodiment of the invention, suture 206 may not be pre-loaded into anchor 202. Instead, a surgeon may pass in situ a first free end of suture 206 through tendon 208 from underside surface 211 through topside surface 209, and then back through tendon 208 from topside surface 209 through underside surface 211, leaving a looped end on topside surface 209. The first free end, a second free end of suture 206, or both may then be slidably connected through suture anchor 202 or other suitable structure, whereupon one or both free ends may be passed back through tendon 208 from underside surface 211 through topside surface 209 adjacent the looped end. The two free ends may then be manipulated as described above.
Comparing the known suture construct of
Suture anchors have a generally cylindrical body that may be tapered and have one or more surface features for engaging bone or another implanted device, depending on the manner in which the suture anchor is to be implanted into bone. For example, suture anchors may be screwed, twisted, friction or press-fitted, punched, or otherwise fastened to the bone. Suture anchors can be of various lengths and may range in diameter from 1 mm to 15 mm.
Suture anchors also have a suture attaching mechanism. Such mechanisms are known and can vary widely as to configuration and features for connecting and securing suture to the anchor. A suture attaching mechanism may be made up of one or more separate parts assembled together and attached to the body of the anchor, or it may be formed integrally with the anchor body. For use in accordance with the invention, a suture attaching mechanism should at least initially provide a slidable connection for one or more sutures attached thereto. That is, a suture connected to the suture attaching mechanism should be able to be pulled easily through the suture anchor from at least one side of the suture attaching mechanism at least initially. For example, some known suture anchors may have an internal locking device that initially allows the suture to slide through the attaching mechanism and thereafter allows a surgeon to lock the suture in place. Another known anchor allows the suture to slide through when pulled in one direction and locks the suture in place when the suture is pulled in the opposite direction.
Suture anchors of the invention may be made of one or more biocompatible materials and/or composites thereof as is known in the art. Such materials may include various non-absorbable materials such as metals and metal alloys including, but not limited to, stainless steel, titanium, Nitanol, cobalt, and non-absorbable polyesters. Suture anchor materials may also include various bioabsorbable plastics and other materials including, but not limited to, polyglycolic or polylactic acid polymers. Furthermore, still other materials, such as carbon fiber and other suitable polymers, may be used. Suture anchors of the invention may be made as a single unit using conventional shaping or molding techniques, or they may be made in separate parts assembled together also using conventional methods and techniques.
Note that the invention is not limited to only those suture anchors shown in the FIGS. Various other types of suture anchor configurations, including those configured with any suitable combination of features disclosed herein as well as others known in the art, may be used in accordance with the invention, provided that they include a slidable suture connection operative to receive at least one suture having a looped end and one or two free ends as described above.
In addition to rotator cuff surgery, the looped suture constructs and pre-loaded suture anchors of the invention may be used in a variety of other medical procedures throughout different areas of the body. For example, the invention may be used in biceps tenodesis (proximal or distal), labral and other soft tissue repairs in the shoulder and hip joints, ACL (anterior cruciate ligament) procedures, ligament repairs and reconstruction in the upper and lower extremities, and ligament repairs and reconstruction in the hand/wrist and elbow. The looped suture constructs of the invention advantageously can be of different sizes to accommodate different sized soft tissue fixation.
While a preferred embodiment of the invention has been described and disclosed, modifications to the methods and apparatus described herein are still possible within the scope of the invention. For example, although reference has been made throughout this disclosure to the attachment of suture anchors and suture constructs to bone, the suture anchors and constructs described herein are not limited to attachment to only bone. Alternatively, they may be attached to other structures, such as, for example, suitable implanted devices or constructs. Such implanted devices and constructs may include, for example, hip and knee replacement parts and various types of bone clamps, plates, rods, pins, and related connecting devices.
Note that some embodiments of the invention may not require a suture anchor. For example, a looped suture construct in accordance with the invention may be anchored directly to bone at a surgical site where the bone has features that allow one or more suture free ends to be slidably connected thereto and ultimately secured. The bone features may be natural or surgeon created (e.g., a drilled through-hole through a section of bone to slidably connect a suture). Accordingly, the term “suture attaching mechanism” as used herein is not necessarily limited to a mechanical device, but may also refer to a suitable bone feature that can be used as such.
Note also that the methods and apparatus disclosed herein are not limited to the medical treatment of humans but, alternatively, may be applied to the treatment of animals or used in various educational and/or research activities. For example, the methods and apparatus may be used on cadavers, nonliving animal parts, and/or synthetic parts (that, e.g., simulate soft tissue and bone) for teaching purposes and/or laboratory studies.
Thus it is seen that apparatus and methods of soft tissue fixation using a looped suture construct and, where needed, pre-loaded suture anchors are provided. One skilled in the art will appreciate that the invention can be practiced by other than the described embodiments, which are presented for purposes of illustration and not of limitation, and the invention is limited only by the following claims.
Claims
1. A method of suturing soft tissue comprising:
- passing a loop of suture through soft tissue, the loop of suture exiting the tissue through a first tissue surface;
- passing a free end of the suture through the soft tissue adjacent the loop of suture, the free end of the suture exiting the tissue through the first tissue surface, wherein the suture is slidably connected to a suture attaching mechanism of an anchoring structure such that the attaching mechanism is between the loop of suture and the free end of the suture;
- passing the free end of the suture through the loop of suture;
- applying tension to the free end of the suture such that the soft tissue is pulled into contact with a desired structure and the loop of suture remains open and positioned on the first tissue surface; and
- securing the free end of the suture to maintain the applied tension.
2. The method of claim 1 further comprising prior to the passing of a free end of suture through the soft tissue:
- passing the free end of the suture through the suture attaching mechanism of the anchoring structure.
3. The method of claim 1 further comprising:
- passing a second free end of the suture through the soft tissue adjacent the loop of suture, the second free end of suture exiting the tissue through the first tissue surface, wherein the suture attaching mechanism is between the loop of suture and the second free end of the suture;
- passing the second free end of the suture through the loop of suture;
- applying tension to the second free end of the suture such that the soft tissue is pulled into contact with the desired structure and the loop of suture remains open and positioned on the first tissue surface; and
- securing the second free end of the suture to maintain the applied tension on the second free end.
4. The method of claim 1 wherein the securing of the free end of the suture to maintain the applied tension comprises:
- securing a second free end of the suture to the free end of the suture to maintain the applied tension, wherein the suture attaching mechanism is between the loop of suture and the second free end of the suture.
5. The method of claim 4 further comprising before the securing of the second free end of the suture to the free end of the suture:
- passing the second free end of the suture through the soft tissue adjacent the loop of suture, the second free end of the suture exiting the tissue through the first tissue surface.
6. The method of claim 1 wherein the securing of the free end of the suture to maintain the applied tension comprises attaching the free end of the suture to a suture anchor implanted in the desired structure.
7. The method of claim 1 further comprising implanting the anchoring structure into the desired structure.
8. The method of claim 1 wherein the anchoring structure has the loop of suture and the free end of the suture pre-loaded therein such that the suture attaching mechanism is between the loop of suture and the free end of the suture.
9. The method of claim 1 wherein the anchoring structure comprises a suture anchor.
10. The method of claim 1 wherein the suture attaching mechanism comprises an eyelet.
11. The method of claim 1 wherein the desired structure comprises bone.
12. The method of claim 1 wherein the anchoring structure and the desired structure are the same.
13. The method of claim 1 wherein the soft tissue comprises a tendon, ligament, or muscle.
14. A method of suturing soft tissue comprising:
- passing a first free end of suture through soft tissue, the first free end exiting the tissue through a first tissue surface;
- passing the first free end of suture back through the soft tissue to form a loop of suture on the first tissue surface, the first free end exiting the tissue through a second tissue surface;
- passing a second free end of the suture through the soft tissue adjacent the loop of suture, the second free end exiting the tissue through the first tissue surface, wherein the suture is slidably connected to a suture attaching mechanism of an anchoring structure such that the attaching mechanism is between the loop of suture and the second free end;
- passing the second free end of the suture through the loop of suture;
- applying tension to the first and second free ends of the suture such that the soft tissue is pulled into contact with a desired structure and the loop of suture remains open and positioned on the first tissue surface; and
- securing the first and second free ends of the suture to maintain the applied tension.
15. The method of claim 14 further comprising passing the first free end of the suture through the suture attaching mechanism of the anchoring structure after forming the loop of suture.
16. The method of claim 15 wherein the securing of the first and second free ends comprises:
- passing the first free end of suture through the soft tissue after passing the first free end through the suture attaching mechanism, the first free end exiting the tissue through the first tissue surface; and
- tying the first and second free ends of the suture together into a knot.
17. The method of claim 14 further comprising pre-loading the anchoring structure with the suture such that the suture attaching mechanism is between the first and second free ends of the suture.
18. The method of claim 17 further comprising implanting the anchoring structure into the desired structure.
19. A method of forming a suture anchor comprising:
- forming a body configured to be implanted into bone;
- connecting to or integrating with the body a suture attaching mechanism configured to provide a slidable connection to suture attached thereto;
- looping a suture on itself to create a looped end of the suture and at least one free end of the suture; and
- connecting the suture to the attaching mechanism such that the attaching mechanism is between the looped end and the at least one free end.
20. The method of claim 19 wherein the suture looped on itself has two free ends, the method further comprising after the looping of a suture on itself:
- bonding one of the two free ends to the suture itself to form the looped end and the at least one free end.
21. The method of claim 20 wherein the connecting of the suture to the attaching mechanism comprises connecting the suture to the attaching mechanism such that the looped end and the bonding of one the two free ends to the suture is on one side of the attaching mechanism and the at least one free end is on another side of the attaching mechanism.
22. The method of claim 20 wherein the connecting of the suture to the attaching mechanism comprises connecting the suture to the attaching mechanism such that the looped end is on one side of the attaching mechanism and the bonding of one the two free ends to the suture and the at least one free end are on another side of the attaching mechanism.
23. A suture anchor comprising:
- a body configured to be implanted into bone;
- a suture having a looped end and at least one free end; and
- a suture attaching mechanism connected to or integrally formed with the body and configured to provide a slidable connection to suture connected thereto, the suture attaching mechanism connected to the suture between the looped end and the at least one free end.
24. The suture anchor of claim 23 wherein:
- the suture has two free ends; and
- the suture attaching mechanism is connected to the suture between the looped end and the two free ends.
25. The suture anchor of claim 23 wherein the suture attaching mechanism comprises an eyelet.
26. The suture anchor of claim 23 further comprising a plurality of sutures slidably connected to the suture attaching mechanism, each of the plurality of sutures having a looped end and at least one free end, the suture attaching mechanism connected between each looped end and its respective at least one free end.
27. The suture anchor of claim 23 wherein the body comprises self-tapping threads.
28. A looped suture construct comprising:
- a suture having a looped end and at least one free end; and
- a suture anchor slidably connected to the suture such that the suture anchor is between the looped end and the at least one free end; wherein:
- the looped end is open and positioned on a surface of a soft tissue;
- the at least one end is passed through the soft tissue and the looped end and is tensioned such that the looped end remains open and positioned on the soft tissue surface; and
- the at least one free end is secured to maintain the tension.
29. The looped suture construct of claim 28 wherein:
- the suture has a second free end;
- the suture anchor is between the looped end and the second free end; and
- the at least one free end is secured to the second free end to maintain the tension.
30. The looped suture construct of claim 28 wherein:
- the suture has a second free end;
- the suture anchor is between the looped end and the second free end;
- the second free end is passed through the looped end and tensioned such that the looped end remains open and positioned on the soft tissue surface; and
- the second free end is secured to maintain the tension.
Type: Application
Filed: Mar 25, 2011
Publication Date: Sep 29, 2011
Inventor: Joshua B. Frank (New York, NY)
Application Number: 13/071,771
International Classification: A61L 17/00 (20060101);