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.
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.
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 can be complex and difficult to use, and can be limited to use in certain procedures or situations.
The present invention provides a suture lock and related methods for fixing the strands of one or more sutures relative to tissue that is simple and reliable in use, facilitates complete perforation closure and adjustment of the suture strands, and that is adaptable to a variety of suture fixation and perforation closure situations. According to one embodiment of the suture lock, constructed in accordance with the teachings of the present invention, the suture lock generally includes a locking cylinder and a retaining sleeve. The locking cylinder has a tubular body defining an interior surface and an exterior surface. The interior surface defines a first interior passageway. The tubular body defines a first aperture and a second aperture that are spaced apart and in communication with the first interior passageway, and adapted for threading suture strands therebetween. The retaining sleeve defines a second interior passageway sized to receive the tubular body of the locking cylinder. The second interior passageway is sized to compress the suture strands between the tubular body and the retaining sleeve.
According to more detailed aspects of the suture lock, the first and second apertures are located between the ends of the locking cylinder. The suture strands extend along the exterior surface of the tubular body between the first and second apertures, and the suture strands are compressed between the exterior surface of the tubular body and the interior surface of the retaining sleeve when the second interior passageway receives the tubular body of the locking cylinder. The locking cylinder also includes a peripheral rim projecting from the tubular body that defines a shoulder sized and positioned to abut a distal end of the retaining sleeve. The distal end of the retaining sleeve is tapered, and preferably defines an end surface that is angled relative to a longitudinal axis of the retaining sleeve. The angled end surface facilitates the capture of the suture strands between the locking cylinder and the retaining sleeve. The locking cylinder and retaining sleeve compress the suture strands along sections of their length, the compressed sections extending between the first and second apertures.
According to another embodiment of the suture lock constructed in accordance with the teachings of the present invention, the suture lock generally includes a locking cylinder and a retaining sleeve. The locking cylinder has a tubular body defining a first interior passageway. The tubular body also defines a first aperture and a second aperture in communication with the first interior passageway. The retaining sleeve defines a second interior passageway sized to receive the tubular body of the locking cylinder. The suture lock is operable between an unlocked configuration and a locked configuration. The locking cylinder and retaining sleeve are connected in the locked configuration and are separated in the unlocked configuration. The locking cylinder and retaining sleeve compress elongate sections of the suture strands in the locked configuration. The elongate sections of the suture strands extend between the first and second apertures. According to further details, the suture strands extend through the first interior passageway, the first aperture, and the second aperture. The elongate sections of the suture strands are located outside of the tubular body in the locked configuration. The first and second apertures are sized and positioned to frictionally engage the suture strands with the locking cylinder when sufficient tension is placed on the suture strands.
A method for fixing strands of one or more sutures relative to tissue is also provided in accordance with the teachings of the present invention. According to the method, a suture lock is provided that generally includes a locking cylinder and a retaining sleeve, such as those described above. The suture strands are threaded through the locking cylinder. Specifically, the suture strands extend through the first internal passageway, through the first aperture, along the exterior of the tubular body, through the second aperture, and again through the first internal passageway. The locking cylinder is translated distally along the suture strands. The suture strands are threaded through the second internal passageway of the retaining sleeve, and the retaining sleeve is translated distally along the suture strands. The suture strands are placed in tension, and the retaining sleeve is translated over the locking cylinder to compress the suture strands between the retaining sleeve and locking cylinder.
According to more detailed aspects of the method, tension on the suture strands is maintained during the step of distally translating the locking cylinder. Tension on the suture strands is also maintained during the step of translating the retaining sleeve over the locking cylinder. The suture strands may be tensioned sufficiently to frictionally retain the locking cylinder at a desired position along the suture strands. The friction between the locking cylinder and suture strands may be overcome to adjust the position of the locking cylinder. Similarly, different tension may be placed on different suture strands, and the position of the locking cylinder adjusted. The locking cylinder and retaining sleeve are connected through their respective frictional engagement of the suture strands. When the tissue includes a perforation and the suture strands are connected to the tissue around the perforation, the step of placing the suture strands in tension includes substantially closing the perforation. The perforation is preferably closed against a distal end surface of the locking cylinder.
Turning now to the figures,
The locking cylinder 22 generally comprises a tubular body 26 having an interior surface 28 and an exterior surface 30. The tubular body 26 and its interior surface 28 define a first interior passageway 32. A first aperture 34 and a second aperture 36 are formed in the tubular body 26 and extend from the exterior surface 30 to the interior surface 28. The first and second apertures 34, 36 are longitudinally spaced apart, although it will be recognized by those skilled in the art that the first and second apertures 34, 36 may be circumferentially spaced apart, or both longitudinally and circumferentially spaced apart. The first and second apertures 34, 36 are located between the proximal end 38 and the distal end 40 of the locking cylinder 22. The distal end 40 of the locking cylinder 22 also includes a peripheral rim 42 projecting radially from the tubular body 26 and defining a shoulder 44 for abutting against the retaining sleeve 24, as will be described further hereinbelow.
The retaining sleeve 24 generally includes an interior surface 48 and an exterior surface 50. The interior surface 48 defines a second interior passageway 52 that is sized to receive the tubular body 26 of the locking cylinder 22 therein. The retaining sleeve 24 includes a proximal end 54 and a distal end 56. The distal end 56 is preferably tapered, such as a chamfer, and defines an end surface 58 that is angled (preferably less than 90 degrees) relative to the longitudinal axis 18 of the retaining sleeve 24. The angled end surface 58 prevents interference when the locking cylinder 22 is inserted through the retaining sleeve 24, and facilitates the capture of the suture strands 10 between the locking cylinder 22 and sleeve 24.
The suture strands 10 extend from the tissue 12 to the locking cylinder 22, through the first interior passageway 32, through the first aperture 34, along the exterior surface 30 of the tubular body 26, through the second aperture 36, and again through the first interior passageway 32. As best seen in
It will be recognized that the locking cylinder 22 may have a discontinuous first interior passageway 32. For example, the cylinder 22 may be solid between the first and second apertures 34, 36, or may have cross members or other elements extending across the interior passageway 32 (as shown by the dotted lines in
Turning now to
A first pushing catheter 60 is used to distally translate the locking cylinder 22 along the suture strands 10, as indicated by arrow 64 in
Notably, the proximal ends of the suture strands 10 may be pulled in a proximal direction in order to place the suture strands 10 in tension, as indicated by arrow 66 in
With the suture strands 10 in tension, the locking cylinder 22 is translated distally to a position proximate the tissue 12, as shown in
The suture strands 10 are also threaded through the retaining sleeve 24, and in particular through the second interior passageway 52. As best seen in
As the retaining sleeve 24 is distally translated over the tubular body 26 of the locking cylinder 22, the elongate sections 10a of the suture strands 10 are compressed, and the locking cylinder 22 and retaining sleeve 24 are connected through their respective frictional engagement of the suture strands 10. The tension on the suture strands 10 is preferably maintained while the retaining sleeve 24 is translated over the locking cylinder 22. The relative positions of the locking cylinder 22 and retaining sleeve 24 are limited by the peripheral rim 42 and shoulder 44 of the locking cylinder 22, which abuts the distal end 56 of the retaining sleeve 24 as shown. Preferably, the perforation 14 in the tissue 12 is closed against a distal end surface 46 of the locking cylinder 22. To release the suture lock 20, the suture strands 10 may be cut, or the first pushing catheter 60 may be used to hold the locking cylinder 22 while the retaining sleeve 24 is grasped (such as with a snare, forceps or similar device) and physically withdrawn against the friction of the suture strands 10.
It will be recognized by those skilled in the art that prior to interconnection of the locking cylinder 22 and retaining sleeve 24, the tension in the suture strands 10 may be modified to facilitate adjustment of the position of the locking cylinder 22. Similarly, different tension may be placed on different suture strands 10, and the position of the locking cylinder 22 adjusted accordingly. The components of the suture lock 20 may be constructed of many materials, such as stainless steel, titanium, nitinol or other metals/alloys, as well as various ceramics or plastics such as polycarbonates (PC), polyamides including Nylon(™). 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.
Preferably, the method is performed under direct visualization, such as through the use of an endoscope or other fiber optic-based visualization systems including catheter-based systems. As such, positioning of the locking cylinder 22 may be viewed and adjusted. In some situations, the size of the suture lock 20 and the pushing members (e.g. catheters 60, 62) are such that the suture lock system may be employed through the working channel of an endoscope, although the system may also be employed in parallel with an endoscope or other visualization system. Thus the pushing members, and preferably the suture lock, are sized for delivery through the working channel of an endoscope. It will also be recognized that other visualization techniques, such as ultrasound, fluoroscopy and the like may be employed in conjunction with the devices and methods of the present invention. For example roughing certain portions of the suture lock 20 may be ideal for use with an ultra-sound capable endoscope. Finally, an appropriate handle or actuator for controlling the relative translation of the pushing members such as the pushing catheters 60, 62 will be readily envisioned by one of ordinary skill in the art.
While the disclosed suture locks and methods are applicable to a variety of suturing situations, the suture locks are especially useful in closing perforations in internal bodily walls, such as those formed in transluminal procedures. In such procedures, a perforation or opening is formed in the wall of one lumen, say the gastric wall, and a medical device such as an endoscope is placed through that opening for access to an adjacent structure or cavity, such as the peritoneal cavity. While there are many benefits of such minimally invasive procedures, complete and proper closure of the opening is essential to the success of such procedures. The suture locks and methods of the present invention are particularly well suited for closing these perforations since they are simple and reliable in use, and are adaptable to a variety of suture fixation and perforation closure applications. For example, any number of sutures and their suture strands may be employed, and the relative sizes of the locking cylinder and retaining sleeve may be adjusted based on suture size, perforation size and the like. Superior control over the positioning of the suture lock is provided, while at the same time providing a device or method that is easy to use and deploy. The suture locks may be used in open surgery, endoscopically, laparoscopically, or in other minimally invasive interventional procedures.
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.
This application claims the benefit of U.S. Provisional Application Ser. No. 60/956,575, filed on Aug. 17, 2007, entitled “SUTURE LOCK”
Number | Date | Country | |
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60956575 | Aug 2007 | US |