Suture lock

[0001] This application claims the benefit of U.S. Provisional Application Ser. No. 60/941,086 filed on May 31, 2007, entitled “SUTURE LOCK,” the entire contents of which are incorporated herein by reference.

[0002] The present invention relates generally to suture locks for fixing the strands of one or more sutures relative to bodily tissue, such as for closing perforations in the tissue.

[0003] Perforations in the walls of internal organs and vessels may be naturally occurring, or formed intentionally or unintentionally. In order to permanently close these perforations and allow the tissue to properly heal, numerous medical devices and methods have been developed employing sutures, adhesives, clips, staples, anchors and the like. Many of these devices typically employ one or more sutures, the strands of which must be brought together and fixed in place in order to close the perforation.

[0004] Manually tying sutures strands together to close a perforation can be very complex and time consuming. For example, a significant level of skill and coordination is required by the medical professional, especially when the perforation and sutures are difficult to access within the body, such as in endoscopic or laparoscopic procedures. The numerous difficulties with manually tying sutures are well documented. In order to address these and other issues of manual suture tying, various automatic suture tying systems have been developed. Unfortunately, such automatic systems are often complex and costly, difficult to use, and limited to use in certain situations.

[0005] The present invention provides suture locks, as well as related systems and methods, for fixing strands of one or more sutures relative to tissue. The suture locks are simple and reliable in use, facilitate complete perforation closure and adjustment of the suture strands, and are adaptable to a variety of suture fixation and perforation closure situations. According to one embodiment of a suture lock constructed in accordance with the teachings of the present invention, the suture lock generally includes a locking pin and a retaining sleeve. The locking pin has a main body and a grip. The grip extends radially from the main body and defines an annular edge. The retaining sleeve has a tubular body within an internal wall defining an internal passageway sized to receive the locking pin therein. The suture lock is operable between a locked configuration and unlocked configuration. In the locked configuration, the suture strands are compressed between the grip and the internal wall of the tubular body.

[0006] According to more detailed aspects of the suture lock, the suture strands are compressed between the annular edge of the grip and the internal wall of the tubular body in the locked configuration. Preferably, the suture strands are also compressed between the main body and the internal wall of the tubular body in the locked configuration. The locking pin and retaining sleeve are connected in the locked configuration through their respective frictional engagement of the suture strands. In the locked configuration, the grip is structured to permit translation of the suture strands in a proximal direction (i.e. away from the tissue) and prevent translation of the suture strands in a distal direction (i.e. towards the tissue). The grip is preferably formed at a distal tip of the locking pin, and most preferably is dome-shaped.

[0007] Another embodiment of the present invention includes a system for fixing strands of one or more sutures relative to tissue. The system generally comprises a suture lock, a first pushing catheter, and a second pushing catheter. The suture lock includes a locking pin and a retaining sleeve. The retaining sleeve has a tubular body and includes a peripheral rim extending radially from the tubular body to define a first shoulder facing proximally. A stop extends radially from the main body to define a second shoulder facing proximally. The first pushing catheter defines a first lumen sized to receive the tubular body of the retaining sleeve and abut the first shoulder. The second pushing catheter defines a second lumen sized to receive the main body of the locking pin and abut the second shoulder.

[0008] According to more detailed aspects of the system, the first lumen of the first pushing catheter is sized to receive the second pushing catheter. Relative translation of the first pushing catheter and the second pushing catheter controls the relative positions of the retaining sleeve and the locking pin to operate the suture lock between a locked configuration and an unlocked configuration. The stop of the locking pin is sized to abut against the tubular body of the retaining sleeve to limit the relative positions of the locking pin and the retaining sleeve. The stop is also positioned relative to the grip to prevent the grip from passing completely through the internal passageway of the retaining sleeve. The suture strands pass through the second lumen of the second pushing catheter to a location outside of the body for manipulation thereof.

[0009] Another embodiment of the present invention provides a method for fixing strands of one or more sutures relative to tissue. The method generally comprises providing a suture lock, a first pushing catheter and a second pushing catheter, such as those described above. The retaining sleeve is engaged with the first pushing catheter, and the retaining sleeve is positioned proximate the tissue with the suture strands extending through the internal passageway of the retaining sleeve. The suture strands are placed in tension. The locking pin is engaged with the second pushing catheter and positioned within the internal passageway of the retaining sleeve such that the suture strands are compressed between the locking pin and the tubular body.

[0010] According to more detailed aspects of the method, the suture strands may be pulled in the proximal direction while pushing the second pushing catheter and the locking pin distally. The second pushing catheter and the locking pin are pushed distally relative to the first pushing catheter and retaining sleeve. The method may further include the steps of adjusting the tension on the suture strands. Preferably, the one or more sutures are placed around a perforation in the tissue, and the suture strands are placed in sufficient tension to close the perforation. The tension on the suture strands is maintained while the second pushing catheter and locking pin are pushed distally relative to the first pushing catheter and retaining sleeve. The frictional engagement of the locking pin with the suture strands, and of the retaining sleeve with the suture strands, is reinforced by the tension of the suture strands and the natural elasticity of the tissue.

[0018] Turning now to the figures, FIGS. 1-4 depict one embodiment of a suture lock 20 and its components, constructed in accordance with the teachings of the present invention. The suture lock 20 generally comprises a locking pin 22 and a retaining sleeve 24 which are used to fix the strands 12 of one or more sutures relative to bodily tissue 14, such as for closing a perforation 16 in the tissue 14. Preferably, the suture is formed of nylon 2-0 and of the monofilament variety, although any suture material or construction may be used with the suture lock 20 of the present invention. Generally, the suture strands 12 will be placed through the tissue 14 and connected thereto using standard suturing techniques or devices such as T-anchors, staples or the like, leaving the strands 12 on one side of the tissue 14 for tying them together. Although the retaining sleeve 24 and locking pin 22 have been depicted as having circular cross-sections, it will be recognized that other cross-sectional shapes may be used including triangular, square, etc.

[0019] As best seen in FIG. 4, the retaining sleeve 24 generally comprises a tubular body 26 having an interior surface 28 defining an interior passageway 30. A peripheral rim 32 is formed at a distal end of the tubular body 26, and defines a shoulder 34 which is used for placement of the retaining sleeve 24, as will be discussed in further detail herein. Generally, the retaining sleeve 24 receives the suture strands 12 within the interior passageway 30. The suture strands 12 are then fixed in place using the locking pin 22, which is designed to fit within the passageway 30 and pinch or compress the suture strands 12. It will also be recognized that the locking pin 22 may have many configurations (e.g. solid, hollow, regular or irregular shapes), and constructions (e.g. cast, molded, machined, wound (such as with wire), etc.) so long as a portion of the locking pin 22 cooperates with the retaining sleeve 24 to fix the suture strands 12.

[0020] As best seen in FIG. 3, the locking pin 22 generally comprises a main body 36, a grip 38, and a stop 40. The main body 36 defines a longitudinal axis 18, and both the grip 38 and stop 40 extend radially from the main body 36. In the illustrated embodiment, the grip 38 is formed at a distal end of the locking pin 22, although it could be moved proximally along the length of the main body 36. The grip 38 defines an annular edge 42 that is used to engage the suture strands 12, as will be discussed in more detail herein. The grip 38 includes a leading surface 44 located distally of the annular edge 42, and a trailing surface 46 located proximally of the annular edge 42. The leading surface 44 tapers, and most preferably is curved such as the dome-shaped surface (e.g., semi-spherical) shown in FIGS. 1-3. At the same time, the trailing surface 46 is generally transverse to the longitudinal axis 18. While the trailing surface 46 has been shown as perpendicular to the longitudinal axis 18 in the figures, any shape or angle relative to the leading surface 44 which is sufficient to define the annular edge 42 suitable for gripping the suture strands 12 is encompassed herein and by the use of the term “transverse.” As shown in FIG. 3, the main body 36 also includes a tapered portion 36a and reduced diameter portion 36b located between the grip 38 and stop 40.

[0021] The stop 40 is longitudinally spaced from the grip 38 and is used to control the position of the locking pin 22 within the retaining sleeve 24. The stop 40 generally includes a distally facing surface 48 and a proximally facing surface 50. The proximally facing surface 50 and main body 36 define a shoulder 52 which is used to position the locking pin 22, as will be discussed in more detail herein. The stop 40 is positioned relative to the grip 38 to prevent the grip 38 from passing completely through the internal passageway 30 of the retaining sleeve 24.

[0022] Interconnection of the locking pin 22 and retaining sleeve 24 will now be described with reference to FIGS. 5 and 6, which depict a locked configuration of the suture lock 20 (the unlocked configuration being shown in FIGS. 1 and 2). Generally, the interior passageway 30 of the retaining sleeve 24 is sized to receive at least a portion of the locking pin 22 therein. In the locked configuration, the main body 36 and grip 38 are received within the interior passageway 30 of the retaining sleeve 24. As best seen in FIG. 6, the suture strands 12 are compressed between the grip 38 and the interior surface 28 of the tubular body 26. As the locking pin 22 is advanced (i.e. distally) from left to right in FIG. 6, the tapered leading surface 44 of the grip 38 allows the locking pin 22 to be translated distally relative to the suture strands 12 and retaining sleeve 24. However, due to the generally sharp annular edge 42, it is more difficult to move the suture strands 12 distally relative to the locking pin 22. In this manner, the suture strands 12 are maintained in a fixed relationship relative to one another and to the tissue 14.

[0023] As will be described in more detail herein, the suture strands 12 are generally in tension, due in part to the natural elasticity of the bodily tissue 14, which generally attempts to pull the suture strands 12 distally. Accordingly, while the locking pin 22 may be advanced through the retaining sleeve 24 and slid along the suture strands 12, the tension on the suture strands 12 also exerts a distally directed force on the locking pin 22 via the grip 38 and its annular edge 42. As such, the suture lock 20 is a form of self-motivating locking device that promotes secure fixation of the suture strands 12 relative to the tissue 14. At the same time, the suture strands 12 may be pulled in the proximal direction to adjust suture tension, suture lock position, and/or perforation closure, even when the suture lock 20 is in the locked configuration.

[0024] It can also be seen in FIG. 6 that the main body 36 is sized to at least partially compress the suture strand 12 against the interior surface 28 of the tubular body 26. At the same time, the tapered portion 36a and reduced diameter portion 36b provide an area of limited or no contact with the suture strand 12. These areas may be sized to adjust the level of friction between the suture strands 12 and the suture lock 20, for example based on the type and size of suture material. The stop 40 abuts against a proximal end surface 54 of the tubular body 26, thereby limiting the position of the locking pin 22 within the retaining sleeve 24. The distally facing surface 48 of the stop 40 is generally tapered to slightly compress the suture strands 12 against the tubular member 26, while still allowing the suture strands 12 to exit the suture lock 20 and be translated in a proximal direction.

[0025] The components of the suture lock may be constructed of various materials, such as stainless steel, titanium, nitinol or other metals/alloys, although various ceramics or plastics can also be employed, such as polycarbonates (PC), polyamides including Nylon(TM), polytetrafluorethylenes (i.e. PTFE and EPTFE), polyethylene ether ketones (PEEK), polyvinylchlorides (PVC), polyimides, polyurethanes, and polyethylenes (high, medium or low density), including multi-layer or single layer constructions with or without reinforcement wires, coils or filaments.

[0026] A system and method for employing the suture lock 20 will now be described with reference to FIGS. 7-9. As shown in FIG. 7, the suture strands 12 have been placed through the tissue 14 in proximity to the perforation 16, such as by using T-anchors 13. T-anchors are well known in the art, exemplary T-anchors being disclosed in U.S. Pat. No. 5,123,914 and U.S. patent application Ser. No. 11/946,565 the disclosures of which are incorporated herein by reference in their entireties. The retaining sleeve 24 is fitted onto a distal end of a first pushing catheter 60. The pushing catheter 60 may take the form of any catheter or cannula known in the art, but preferably has sufficient strength and rigidity for both longitudinal and rotational force transmission, while still providing flexibility for navigation of a patient's body. Exemplary pushing catheters are sold by Cook Incorporated and Wilson-Cook Medical, Inc. It will also be recognized that other pushers or pushing elements may be employed, such as solid wires or wire guides, clamps, graspers and the like. Magnets could likewise be employed to releasably connect the pusher to the retaining sleeve 24.

[0027] The pushing catheter 60 has a distal end surface 62 and a first lumen 64. The first lumen 64 is sized to receive the tubular body 26 of the retaining sleeve 24, while the distal end surface 62 of the pushing catheter 60 abuts against the shoulder 34 of the retaining sleeve 24. Generally, the pushing catheter 60 and retaining sleeve 24 are loosely press fit such that the retaining sleeve 24 may be readily controlled and positioned using the catheter 60. Likewise, the retaining sleeve 24 maintains its connection to the catheter during placement of the locking pin 22 within the sleeve 24, while at the same time the retaining sleeve 24 is also readily disconnected from the pushing catheter 60 at the end of the procedure. It will be recognized that the pushing catheter 60 and retaining sleeve 24 need not be sized to frictionally engage, as the tensioned suture strands 12 and the tissue 14 will generally maintain the position of the retaining sleeve 24 on the pushing catheter 60 during placement of the locking pin 22, such as is shown in FIGS. 8 and 9.

[0028] With reference to FIG. 7, the suture strands 12 are threaded through the interior passageway 30 of the retaining sleeve 24 and through the first lumen 64 of the first pushing catheter 60. The pushing catheter 60 is used to distally translate the retaining sleeve 24 over the suture strands 12 to a position proximate the tissue 14 and perforation 16. The suture strands 12 are tensioned in order to draw the perforation 16 closed and press the tissue against the peripheral rim 32 of the retaining sleeve 24.

[0029] As shown in FIG. 8, a second pushing catheter 70 is loosely press fit with the locking pin 22, although the two structures may simply abut each other for longitudinal translation. The second pushing catheter 70 may have a construction similar to the first pushing catheter 60 or other pusher described above. In the depicted embodiment, the second pushing catheter 70 includes a distal end 72 and second lumen 74 which are sized to abut against the shoulder 52 and receive the main body 36 of the locking pin 22, respectively. Accordingly, the second pushing catheter 70 is connected to the locking pin 22 and together they are translated distally through the first lumen 64 of the first pushing catheter 60. The locking pin 22 is pressed into engagement with the retaining sleeve 24 to fix the suture strands 12 therebetween. With the suture strands 12 in tension (e.g. by pulling them in a proximal direction), the locking pin 22 is advanced through the interior passageway 30 of the retaining sleeve 24, whereby the suture strands 12 are compressed between the grip 38 and the interior surface 28 of the retaining sleeve 24. It can therefore be seen that relative translation of the first pushing catheter 60 and the second pushing catheter 70 controls the relative positions of the retaining sleeve 24 and locking pin 22 to operate the suture lock 20 between a locked configuration and an unlocked configuration.

[0030] As previously discussed, the leading surface 44 of the grip 38 is slid along the suture strands 12 as the locking pin 22 is distally advanced through the interior passageway 30. With further advancement, the main body 36 also engages the suture strands 12 and at least partially compresses them against the interior surface 28 of the retaining sleeve 24. The annular shape of the grip 38 allows the suture strands 12 to be positioned anywhere around the outer periphery of the grip 38 and locking pin 22. Distal movement of the locking pin 22 is eventually limited by the stop 40, and namely the distally facing surface 48 of the stop 40 abutting against the proximal end surface 54 of the retaining sleeve 24. The tension on the suture strands 12 grips into the annular edge 42 of the grip 38, and serves to promote movement of the locking pin 22 in the distal direction, as well as resist proximal movement and unlocking of the suture lock 20.

[0031] When in the locked configuration (and when partially locked such as when the locking pin 22 partially placed within the retaining sleeve 24 but not fully seated), the grip 38 is structured to permit further translation of the suture strands 12 proximally, i.e. away from the tissue 14, and prevent translation of the suture strands 12 distally, i.e. towards the tissue 14. Further, the suture strands 12 may be individually pulled or tensioned in order to orient the suture lock 20 relative to the bodily tissue 14 and perforation 16, even when the suture strands 12 are compressed by the locking pin 22 and retaining sleeve 24, such as when the suture lock 20 is in the locked configuration. As such, tension on the suture strands 12 may be modified to adjust how the perforation 16 is closed. This represents a marked improvement over existing suture locks, which typically are permanently fixed in position along the sutures such that adjustment during and after the locking procedure, i.e. in partially locked and finally locked configurations, is not possible.

[0032] In the fully locked condition, as shown in FIG. 9, the tension on the suture strands 12, as well as the natural elasticity of the tissue 14, result in a force being transmitted through the suture strand 12 to the grip 38 biasing it in the distal direction. In this manner, the retaining sleeve 24 and locking pin 22 are interconnected through their respective frictional engagement with the suture strands 12 and compression thereof. In the locked condition, the first and second pushing catheters 60, 70 are easily removed from the retaining sleeve 24 and locking pin 22, respectively, and may be withdrawn from the patient. The suture strands 12 may be trimmed as necessary. To release the suture lock, the suture strands 12 may be cut, or the first pushing catheter 60 may be used to hold the retaining sleeve 24 while the retaining pin 22 is grasped (such as with a snare, forceps, or similar device) and physically withdrawn against the friction and tension of the suture strands 12.

[0033] Accordingly, the present invention provides a suture lock, as well as a system and method for deploying the suture lock, which is simple and reliable in use, provides complete perforation closure, and which is adaptable to a variety of suture fixation and perforation closure applications. For example, any number of suture strands may be employed and the relative sizes of the locking pin and retaining sleeve may be adjusted based on suture size, perforation size and the like. The interconnection of the locking pin and retaining sleeve is such that the suture lock is self-motivated and biased towards a locked configuration, thereby assisting and promoting complete perforation closure as well as control over the position of the suture lock relative to the tissue being sutured through adjustment of the suture strands even when they are compressed. Adjustment of individual suture tension and location of the suture lock are also possible during and after placement of the suture lock. At the same time, the two pushing catheters provide a simple system for deployment of the suture anchor that can be traversed through the body of a patient to even the most remote locations.

[0034] The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.