Suture clip deployment devices

Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place.

FIELD

This disclosure relates to devices and methods for securing sutures using clips.

BACKGROUND

Sutures are used for a variety of surgical purposes, such as approximation of tissue and ligation of tissue. When placing sutures, the strand of suture material to be used typically has a needle affixed to one end which is passed (looped) through the tissue to be approximated or ligated, forming a stitch. The stitch is then tensioned appropriately, and the two free ends of the suture loop, the needle end and the non-needle end, are knotted to retain the desired tension in the stitch. Forming knots in suture during open surgery is a simple matter, though time-consuming, but forming knots in sutures during endoscopic surgery can require two surgeons to cooperate in a multi-step process which is performed with multiple instruments to pass the needle and suture back and forth to tie the suture knot.

Suture locking devices that eliminate the need to tie knots in order to speed up heart valve replacement are known, as are suture locking devices in general. Suture retainers or locks are used in place of suture knots to prevent passage of a suture end into and through tissue and to maintain the tension applied to the suture material during the suturing procedure.

When using a method that employs a clip to secure the suture, the clip can be delivered by advancing the clip along a suture line to the area of interest, and then deploying the clip such that the clip secures the suture in place. With the clip thus secured, the excess suture can be cut and removed from the patient. An example of such a clip as well as methods and devices for use therewith are disclosed in U.S. Patent Pub. No. 2007/0005081 and U.S. Pat. No. 7,628,797, the entire contents of which are expressly incorporated herein by reference.

Despite the existence of knotless suture locking devices in the art, there is a need for improved devices that enable easy access to the suture, accurate tensioning of the suture and are simple to use. In light of the foregoing, there is presently a need for improved systems for securing sutures with clips.

SUMMARY

Disclosed herein are improved suture clip delivery devices and systems that are especially useful for securing heart valve repair or replacement prostheses in or near the heart. The devices and methods are particularly well suited for traditional surgery or minimally invasive surgery. The devices disclosed herein can eliminate the need for surgical knots thus reducing surgical time and exposure. Further, the devices can improve the ease of implantation because the clinician need not tie knots in the limited space in and around the heart.

Some embodiments of suture clip delivery systems described herein utilize a suture clip having a generally tubular shape, with an inner lumen passing through the tube and a handheld vacuum-assisted device for deploying the suture clips. The inner lumen of the device and clip is sized and configured so that one or more lines of suture may pass therethrough. The clip has an open configuration wherein the inner lumen is generally unobstructed, and a closed configuration wherein the inner lumen is at least partially obstructed so that suture line(s) passing therethrough are prevented from moving in one or more directions.

An exemplary system disclosed herein includes a device having a generally tubular main body with a proximal end, a distal end, a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, a suture recess located in the generally tubular main body, and at least one suture clip configured to frictionally fit on an outer surface of the inner body. The main body further comprises a mechanical advancer button and clip deployment occurs when the device is mechanically actuated via the mechanical advancer button. Multiple clips can be loaded onto the inner body for deployment. The clips are preferably made of a shape memory material.

Also disclosed herein is are methods for anchoring an implant to soft tissue, the implant having been advanced to the soft tissue down a plurality of suture lines, comprising providing a delivery device having a generally tubular main body with a proximal end, a distal end, a vacuum port located at the distal end, an inner body longitudinally slidable within the main body and extending from the main body at its distal end, a suture recess located in the generally tubular main body, and at least one suture clip configured to frictionally fit on an outer surface of the inner body; connecting a vacuum source to the vacuum port; approaching the suture lines with a distal end of the inner body of the device; applying a vacuum so as to draw the suture lines into the distal end of the delivery device and through the main body; retrieving the suture lines through the suture recess; adjusting tension in the suture lines; and actuating the device so as to force the suture clip off the inner body and onto the suture lines so as to lock the suture lines in place.

Some disclosed devices for deploying a suture clip onto a suture comprise a proximal handle portion comprising an actuation mechanism and a generally tubular main shaft having an inner lumen, a proximal end portion coupled to the actuation mechanism, a distal end portion having a distal opening in communication with the inner lumen, and an intermediate portion having a radial opening in communication with the inner lumen. The main shaft is configured to hold one or more annular suture clips loaded on the distal end portion of the main shaft and the main shaft is also configured to receive at least one suture extending through the distal opening, through the inner lumen, and through the radial opening. The device further comprises a pusher positioned at least partially around the main shaft and coupled to the actuation mechanism independently of the main shaft. The pusher is configured to be positioned proximal to the one or more suture clips when the one or more suture clips are loaded on the main shaft. The actuation mechanism is configured to cause the main shaft to move proximally relative to the handle portion, the pusher, and the one or more suture clips loaded on the main shaft, such that a distal-most one of the one or more suture slips slides distally off of a distal end of the main shaft and onto a suture extending through the distal opening of the main shaft.

In some embodiments, the inner lumen of the main shaft is fluidly couplable to a vacuum source that reduce pressure within the inner lumen such that a suture can be drawn into the inner lumen through the distal opening of the main shaft.

In some embodiment, the handle portion comprises a vacuum source that is fluidly coupled the inner lumen of the main shaft to assist in drawing a suture through the distal opening and into the inner lumen. The handle portion can further comprise a manual vacuum controller that controls the vacuum in the inner lumen.

In some embodiments, the device is configured such that, after a suture clip is deployed onto the suture, the actuation mechanism causes the main shaft, the pusher, and any suture clips remaining on the main shaft to move distally together relative to the handle portion.

Some embodiments further comprise an outer shaft positioned around the main shaft and the pusher and coupled to the handle portion. The outer shaft comprises a blade at a distal end portion that is configured to cut the suture after the suture clip is deployed onto the suture. The cutting of the suture occurs between the distal end of the main shaft and a proximal end of the deployed suture.

In some embodiments, the actuation mechanism causes the outer shaft to rotate relative to the main shaft and the handle portion, and wherein the rotation of outer shaft causes the cutting of the suture.

Some embodiments further comprise a cover member slidably mounted over the radial opening of the main shaft, the cover member being configured to selectively open and close the radial opening of the main shaft.

In some embodiments, the pusher comprises a ratcheting mechanism that allows the pusher to slide distally relative to the main shaft but prevents the pusher from sliding proximally relative to the main shaft.

In some embodiments, the device is configured to be loaded with a plurality of suture clips that are deployable without reloading the device.

Some embodiments further comprise a suture tension monitoring system configured to determine and display the amount of tension in a suture positioned within the inner lumen of the main shaft.

Some embodiments further comprise a suture clip monitoring system configured to determine and display the number of suture clips that are currently loaded on the main shaft.

Some embodiments further comprise a lighting system configured to provide light near the distal end of the main shaft. The lighting system can comprise one or more light fibers that extend along the length of the main shaft and are configured to conduct light from a proximal light source to near the distal end of the main shaft.

Some embodiments further comprise a visual monitoring system configured to capture visual information from the near the distal end of the main shaft and transfer the captured visual information to a proximal visual display.

In some embodiments, the one or more suture clips are comprised of a shape-memory material, wherein the one or more suture clips are held in a resiliently deformed annular configuration when loaded onto the main shaft, and wherein the one or more suture clips resiliently return toward a natural collapsed configuration when deployed onto the suture, thereby becoming frictionally secured to the suture.

An exemplary method for deploying a suture clip onto a suture comprises causing a free end of at least one suture to enter into a distal end portion of an inner lumen of a main shaft of a suture clip deployment device, and then causing the main shaft to move proximally relative to a suture clip mounted around an outer surface of the main shaft such that the suture clip slides distally off of a distal end of the main shaft and onto the at least one suture such that the suture clip resiliently secures to the suture.

In some methods, inserting a free end of the suture into the distal end portion of the inner lumen comprises reducing the air pressure within the inner lumen in order to draw the free end of the suture into the inner lumen.

In some methods, inserting a free end of the suture into the a distal end portion of the inner lumen comprises drawing the free end of the suture out of the inner lumen through a lateral opening in the main shaft.

Some methods further include applying tension to the free end of the suture projecting from the lateral opening.

Some methods further include causing a blade of the suture clip deployment device to cut off the free end of the suture after the suture clip is secured to the suture. Such methods can further include, after the suture is cut, causing the main shaft and suture clips remaining mounted on the main shaft to move distally relative to a handle portion of the suture clip deployment device. After the main shaft and suture clips remaining mounted on the main shaft to move distally relative to a handle portion, the method can include repeating process to deploy another suture clip onto another suture.

A further understanding of the features and advantages of the present invention will become apparent from a consideration of the following detailed description.

DETAILED DESCRIPTION

Described herein devices and methods for securing sutures with suture clips.FIG. 1depicts a suture clip delivery device10according to one embodiment. The handheld suture clip delivery device10has a generally tubular main device body12having a proximal end14and a distal end16. The proximal end14includes a vacuum port80and a suture recess82. The distal end16includes a mechanical advancer button84. Extending past the distal end16of the device is an inner body26, shown here having multiple suture clips20positioned thereon. The inner body26is longitudinally slidably positioned within the main body12of the delivery device. The inner body26includes a distal end28which extends distally out of the main body distal opening24. The vacuum port80located at the proximal end14of the device12is configured to be attached to a vacuum source (not shown). When the user attaches the vacuum port80to any vacuum source, suction is created within the device10. The suction assists the user in drawing the suture lines into the distal end28of the inner body26thereby threading the sutures through the device. The suture lines exit the device10at the suture recess82. It should be noted that the suture clip delivery device10can be manufactured in a variety of shapes, sizes, lengths, widths, and biologically-compatible materials as desired for a particular application.

The device10and the inner body26both feature at least one lumen to allow passage of a suture therethrough as well as to allow for suction via the vacuum port80. Some embodiments may include more than one lumen within the device10. For example, one lumen may extend from the distal end28of the inner body26to the vacuum port80, and another separate lumen may extend from the distal end28of the inner body26to the suture recess82. In either case, suction is used to draw the suture into the device10; the ends of the sutures exit the device10via the suture recess82which enables the user to tension the sutures prior to clip deployment.

FIGS. 2A and 2Billustrate the distal portion of the suture clip delivery device10. As shown, multiple clips20are loaded onto the outer surface of inner body26and are held onto the inner body26by a friction fit, thus preventing the clips20from inadvertently falling off the distal end16of the device10prior to deployment. The inner body26is slidably coupled within the main body of the device12to allow at least partial retraction of the inner body26into the distal end16of the device10.FIG. 2Aspecifically shows the position of the inner body26relative to the clips20and distal end16of the device10prior to actuation using the mechanical advancer button84.FIG. 2Bshows the position of the inner body26relative to the clips20and distal end16of the device10after actuation. Actuation of the delivery device10using the advancer button84will be described in more detail below.

As can be seen inFIGS. 2A and 2B, the inner body26of the delivery device10is slidably positioned within main device body12. A suture clip20is positioned on the inner body distal end28, which protrudes from the main body distal opening24. As depicted inFIG. 2B, the suture clip20is placed on inner member distal end28in its open configuration wherein the clip body is generally straight (i.e., unbent). The suture clip20is secured to the inner body distal end28by means of the frictional engagement of the clip body against the outer surface of inner body26.

Note that a clip according to this particular invention may have a (relatively gentle) curve along its length but still be considered “generally straight.” The term “generally straight” is used to refer to a configuration wherein the clip does not have a relatively tight bend sufficient to cause crimping of the inner lumen.

FIGS. 3A through 3Dillustrate a suture clip20in an “open” configuration, whileFIG. 4depicts the suture clip20in a “closed” or “locked” configuration. The suture clip20can be manufactured from a variety of materials including, for example, nickel-titanium alloys, shape-memory alloys, stainless steel, titanium, various plastics, and other biologically-compatible materials. Suture clip20has a generally tubular body44and an outer wall46, and includes a distal opening50leading to an internal attachment lumen48extending axially through the suture clip20to a proximal opening52. The suture clip20includes one or more engagement tab(s)54a,54bformed in the suture clip20and configured to leave the inner lumen relatively unobstructed when in the “open” configuration as depicted inFIGS. 3A-3D, and to at least partially obstruct the inner lumen48when in a “closed” configuration, as depicted inFIG. 4. The suture clip20includes notches53a,53bformed adjacent the tabs54a,54b, with the notches53a,53bhelping to create a hinge-point55about which the proximal half57aand distal half57bof the clip body44can bend.

The clip body44, distal opening50, proximal opening52, inner lumen48, and engagement tabs54a,54bare sized and configured (when the clip body44and engagement tabs54a,54bare in the “open” configuration as shown inFIGS. 3A-3D) to slidingly receive one or more suture leads therethrough. Prior to deployment, the clip body44is in its open (i.e., straightened) configuration, and the engagement tabs54a,54bare moved to their “open” configuration by being deflected radially out of the inner lumen48such that the engagement tabs54a,54bare essentially flush with the suture clip outer wall46, thereby leaving the inner lumen48essentially unobstructed, or at least unobstructed to the extent necessary for the suture lines to slidingly pass within the lumen48. As depicted inFIG. 3A, the inner lumen48(with the clip body44straightened and the engagement tabs54a,54bin their open configuration) provides a relatively large and unobstructed passage sufficient to permit suture leads to slide therethrough.

Upon deployment, i.e. after the suture leads have been retracted through the delivery device by means of a vacuum applied to the device, and tightened to their desired position, the suture clip20is advanced to its desired deployment position and forced off the end of the delivery device. The clip body44is bent (which may include stressing a plastically deformable clip to assume the bent configuration, or permitting a biased clip to spring back to the bent configuration), with clip bending occurring along a hinge point55. The engagement tabs54a,54bare deflected or permitted to spring back into the inner lumen48toward the hinge point55such that the inner lumen48is at least partially blocked, as depicted inFIG. 4. Suture lines56a,56bare held fast within the closed clip20, with the engagement tabs54a,54bengaging against and securing the suture lines56a,56bagainst the clip body44. The “closed” engagement tabs54a,54band bent clip body44cause the suture lines56a,56bpassing therethrough to adopt a “serpentine” path through the clip inner lumen48. This serpentine path, combined with the friction on the suture from the clip body44and engagement tabs54a,54b, serves to lock the suture56a,56bin place and prevent longitudinal movement thereof within the clip lumen48. The suture56a,56bis thus held secure by the combination of tab54a,54bto clip inner wall interaction/forces and by the tortuous path that the bent clip body44and tabs54a,54bforce the suture lines56a,56bto follow, which provides more surface area contact with the suture56a,56bto increase retention. Note also that the bending of the clip body44holds the tabs54a,54bagainst each other, so that neither of the tabs54a,54bcan bend back outwardly without engaging against the other tab.

As shown inFIG. 4, the suture lines56a,56bare relatively thin as compared to the clip lumen48. However, depending on the particular application, suture that is of a much greater thickness can be used with a clip according to the invention. If used with thicker suture(s), a clip20, and particularly the tabs54a,54b, might assume a somewhat different shape once deployed. With a thicker suture line or lines, the tabs54a,54bwould each be forced back outward (i.e., toward their “open” configuration”) by the suture, but the bending of the clip body44and the resulting interaction between the tabs54a,54bwill prevent excessive tab movement, and the suture will still be held securely within the clip body44.

Depending on the particular embodiment, including the materials from which a particular suture clip is made, the clip body (and the bend therein) as well as the engagement tab(s) may be biased to spring toward a desired position, which may be either the closed configuration or the open configuration, depending on the particular application.

FIGS. 5A-5Cdepict, in various configurations, deployment of a clip20from the distal end16of the suture clip delivery device10according to an embodiment of the invention. FIG.5A depicts the device inner body distal end28extending from device main body distal opening24, with a suture clip20positioned on the inner body distal end28. A suture line56extends through material or tissue portions58a,58band vacuum is used to draw the suture line into the distal end of the device. In the particular embodiment depicted, the clip20is biased towards its closed configuration, and the inner body distal end28of the device10physically holds the clip20in its open configuration. Suture56extends from the suture clip20, with suture leads56aand56bextending through the clip inner lumen48via the clip distal opening50, engagement tab54, and proximal opening52. By virtue of the vacuum, the suture leads56a,56bpass through device inner member distal opening30and inner member lumen32, exiting the inner member26of the device via suture recess82, and exiting the side of main body12(not shown). The user is then able to manually adjust the tension in the suture prior to securing the suture in place.

Clip deployment occurs when the device10is mechanically actuated by the user via the mechanical advancer button84. In one embodiment, the button84is depressed causing the inner body26to be at least partially retracted within the device10. During actuation, as shown inFIGS. 2A-B, the inner body26begins to move proximally toward the distal end16of the device10. With this action, the length of the inner body28outside of the device10is decreased and the proximal end of the most proximal clip20abuts the distal end16of the device10forcing the most distal clip20to edge off of the distal end28of the inner body26. Once the clip20is completely off of the inner body28and strung onto suture56, the clip assumes its “closed position” as described above with reference toFIG. 4and locks the suture in place. The user then withdraws the suture clip device10from the patient, leaving the suture56and suture clip20in place in the desired tissue.

The device inner body distal end28retracts into the main body distal opening24by manipulation of the mechanical advancer button84. With the inner body distal end28retracted, the suture clip20is released from the device10, as shown inFIG. 5B. As the inner body distal end28is retracted, the suture clip20is engaged against the distal edge25of the main body distal opening24and is forced off of the inner body distal end28at a position adjacent the material portions58a,58b. With the suture clip20freed from the device, the clip20assumes its closed (i.e., bent) configuration, with the clip body44bent and the engagement tabs54a,54bprojecting inward to at least partially obstruct or even to completely close the clip inner lumen48while engaging the suture lines56a,56b. With the suture clip20in this closed configuration, the suture lines56a,56bare held fast and cannot move longitudinally within the suture clip20. The suture lines56a,56bare thus held by the combination of tab to inner wall interaction/forces and by the tortuous path that the tabs54a,54band bent clip body44force the suture lines56a,56bto follow, which provides more surface area contact with the suture lines56a,56bto increase retention. Note that the suture lines56a,56bstill pass into the device10, exiting the inner body26via suture recess82and exiting the side of main body12through suture recess82.FIG. 5Cdepicts the device inner body26retracted even further within the device main body12.

FIGS. 6A and 6Billustrate a particular use for the device10to secure with a clip sutures used to attach two layers together, wherein one layer is a cardiac implant78, such as an artificial valve implant and the other is a heart valve annulus. In the embodiment depicted, the suture56has previously been passed through the desired material structures within the patient's body. After suturing the implant78to the heart tissue88with suture56, the user approaches the suture lines with the distal end28of the inner body26of the device10. Vacuum is applied to the device; in some cases, the user covers the suture recess82with his finger to enable suction throughout the length of the device. With the vacuum source connected to the vacuum port80, negative pressure is created within the inner body26of the device along its length from the vacuum port80to the distal end28. The suture lines56are drawn into the distal end28of the inner body26and through the device10, exiting the device10at the suture recess82. The user can then adjust the tension in the suture56using the portions of the suture that are outside the device10. The user can verify the effectiveness of the tightened suture56by monitoring various patient functions. For example, the user may confirm the result by monitoring blood flow using radiopaque dyes combined with fluoroscopy. If the user is dissatisfied with the results when the suture56is initially tightened, the user can remove the suture56entirely from the patient's body and repeat the suture deployment to try to achieve a better positioning of suture. If, however, the user is satisfied with the results, the user deploys the suture clip20from the device10.

Referring still toFIGS. 6A and 6B, after placement of the suture at the desired location and achieving the desired tension, the suture clip20is deployed from the delivery device10. The suture clip20is released from the distal end of the device10, securely holding the suture56in place. The user can then cut the free end(s) of the suture56and remove any excess suture by simply pulling the excess suture out of the patient's body. The user then withdraws the suture clip device10from the patient, leaving the suture56and suture clip20in place.

Note that the number, shape, and configuration of the engagement tabs and hinge points on a particular clip can vary, depending on the particular application. For example, the engagement tabs can be positioned on opposing sides of the clip, on the same side of the clip, in a spiral pattern about the clip body, etc. Similarly, the hinge points can be positioned on opposing sides of the clip, on the same side of the clip, in a spiral pattern, etc.

Various methods and/or systems can be used to pass the suture through the desired material, as is well known in the art. Moreover, althoughFIGS. 6A and 6Bdepict the device used to replace a heart valve, the device can also be used in other procedures, including material treatments such as so-called “edge-to-edge” mitral valve repairs involving edge-to-edge suturing of adjacent mitral valve leaflets. Embodiments of the system may be used to occlude a left atrial appendage for decreasing the risk of arterial embolism, for example. In another procedure, material along the ostium of the left atrial appendage is sutured together to prevent blood from flowing in and out. This procedure is preferably performed using a transeptal approach and may be performed after delivering an expandable device into the left atrial appendage for filling the volume and further preventing the formation of thrombus. In another method of use, the system may be used for occluding fallopian tubes in a minimally-invasive sterilization technique. In this procedure, the system is advanced into a fallopian tube and suture is applied to pull opposing walls together, thereby blocking the tube. In still other applications, the system may be used to treat organ prolapse, such as uterine or bladder prolapse. This procedure may be used to pull tissue together in a percutaneous procedure to treat prolapse by providing additional support at locations wherein muscles and/or ligaments have become stretched or have been otherwise damaged.

Additional information on procedures for which the surgical clip delivery device can be useful are disclosed in the following references, the entire contents of which are expressly incorporated herein by reference: U.S. Pat. No. 6,626,930 issued to Allen et al.; U.S. patent application Ser. No. 10/106,583, filed Mar. 26, 2002 and entitled, “Sequential Heart Valve Leaflet Repair Device and Method of Use”; U.S. patent application Ser. No. 10/233,879, filed Sep. 3, 2002 and entitled “Single Catheter Mitral Valve Repair Device and Method”; U.S. patent application Ser. No. 10/389,721, filed Mar. 14, 2003 and entitled “Mitral Valve Repair System and Method of Use”; and U.S. patent application Ser. No. 11/174,143, filed Jun. 30, 2005 and entitled “System, Apparatus, and Method for Repairing Septal Defects.”

FIGS. 7A-7Fand8A-8E depict, in open and closed configurations, respectively, additional clip configurations. The suture clip20is initially formed from a generally tubular body44, such as a portion of nitinol hypotube into which the desired pattern of tabs54a,54b, tab stress cutout windows66, bending notches53, and stress-relief cuts68, etc., is formed.

Note that the clip20including the pattern of tabs54a,54b, etc., can be formed in various ways, depending on the particular application. For example, injection molding, die and coining, laser cutting, machining, and shape setting can be used, alone or in combination, depending on the particular clip configuration and materials. In one embodiment, the pattern is formed by laser cutting the desired pattern into a portion of a hypotube or other generally tubular body.FIGS. 7A-7Fdepict the generally tubular body44after the desired pattern has been cut into the generally tubular body, but before the tubular body has been bent and before the tabs54a,54bhave been bent or otherwise moved and set into position to block the inner lumen48. The configuration depicted inFIGS. 7A-7Falso corresponds with the “open” configuration of the clip20.

FIGS. 8A-8Edepict the clip20ofFIGS. 7A-7F, but with the clip body44bent and the tabs54a,54bbent into and set in their “closed” position, wherein the inner lumen48is at least partially blocked. The notches53on either side of the clip20create a hinge point55about which the clip20can easily bend. (Note that, although the term “hinge point” is used herein, the actual bending may occur over a relatively large area, as is shown in the embodiment ofFIGS. 8A-8E.) The tab stress cutout windows66enhance the flexibility while maintaining strength of the tabs54a,54b, and also reduce stress on the hinge-like portion where each tab54a,54bconnects to the generally tubular body44of the clip20. The stress relief lines68, which are on the same side of the clip20as the hinge point55, help to relieve stress that might build up on that side of the clip body44as the clip20assumes its bent configuration. In the embodiment ofFIGS. 8A-8E, the free ends of the engagement tabs54a,54bare directed toward each other, and are both on an opposite side of the clip body44from the hinge point55.

FIG. 9depicts, in cross section, a side view of a further embodiment of a clip20. The clip20includes a single tab54positioned across from a hinge point55. The clip20includes a beveled inner edge70at one or more of the clip openings, such as the clip distal opening50as depicted. The beveled inner edge70, which in the embodiment depicted is at an angle of about 45 degrees, can assist in threading suture into the clip20through the clip distal opening50. The clip20can also include one or more generally semi-circular openings72at one or more openings such as the clip proximal opening52. The semi-circular openings72can aid in processing of the clip during manufacture, e.g., permitting easy alignment and holding of the clip20during bending and/or shape setting of the clip body44and tabs54a,54b, etc. After clip manufacturing is complete, the semi-circular openings72can interact with corresponding structure on the device distal end to assist in alignment and positioning of the clip20on the device distal end.

The clip20depicted inFIG. 9also includes a window-like opening74aligned opposite to the free edge of the tab54, positioned so that when the tab54extends into the inner lumen48the free edge of the tab54can rest within the window-like opening74, but without extending out of the clip20itself. The window-like opening74permits tab54to be bent or otherwise positioned so that the tab free edge extends across and just beyond the inner lumen48, thereby compensating for any backward tab movement (either through material recovery or outward pressure from the suture lines, etc.) that might occur after the tab20is initially deployed to its closed configuration. Note that a window-like opening such as element74fromFIG. 9could be positioned at or near a hinge point, so that the window-like opening serves multiple purposes: receiving the tab free edge, relieving stress that might develop adjacent the hinge point, and providing for relatively easy bending or flexing of the clip body about the hinge point.

FIG. 10depicts a cutout pattern (in flattened or unrolled configuration) for creating the suture clips. The generally elliptically-shaped portion76of each the tabs54a,54b(with54bhaving a dashed portion depicting an imaginary completion of the “ellipse” that forms the actual tab) has a width W (i.e., minor axis) that is approximately equal to (but still slightly less than) the diameter of the clip inner lumen48. The generally elliptical shaped portion76has a length L (i.e., major axis) that is greater than the diameter of the clip inner lumen48. These dimensions permit each tab54a,54b, when in the closed configuration, to fit within the clip inner lumen48and still close off essentially the entire diameter of the clip inner lumen48, thereby securely holding any suture passing therethrough.

Note that because the pattern of tabs and windows may have been cut in a radial manner into the generally tubular body44of the clip20, the tabs54a,54beach have an inner surface having an “inner” elliptically-shaped portion that is somewhat smaller in width than its corresponding “outer” elliptically-shaped portion76discussed above. Accordingly, the relatively narrow width of each tab's respective inner elliptically-shaped portion may only partially obstruct the inner lumen48. However, the tab outer surface has the full width W of the elliptically-shaped portion76shown inFIG. 10, and it is this width (W) of the “outer” elliptically-shaped portion76that obstructs the remaining diameter of the inner lumen48when a tab54a,54bextends into the inner lumen48.

The dimensions of the clip can vary depending on the particular application. In one embodiment, a clip20such as that depicted inFIGS. 7A-7Fhas a length of about 0.13 inches, an inner lumen diameter of about 0.030 inches, and an outer diameter of about 0.046 inches. A clip of this size can receive and secure multiple suture lines having various diameters, including sutures having diameters ranging from 0.006 to 0.008 inches. Other clip dimensions are also within the scope of the invention, with the clip dimensions varying depending on aspects of the particular application, e.g., suture type and diameter, the type of material to be repaired, the number of suture lines being secured by the clip, etc. Additionally, although the particular embodiments depicted have used the clip to secure two suture lines, the clip could be used to secure a single suture line or multiple suture lines. For multiple suture lines, two or more of the multiple suture lines could be portions of a common suture line. For example, a clip could be used to secure four suture lines, with two of those suture lines being opposing portions of a first common suture line and the other two suture lines being opposing portions of a second common suture line. Note that the embodiments depicted are only a few examples of many that are within the scope of the invention. Depending on the particular embodiment, the tab and other cut-outs could be formed in various shapes, and they could be aligned in a common direction with other cutouts, be in opposite directions of alignment, and/or could be positioned in various directions along the clip outer wall.

FIGS. 11A-11Cdepict in cross-section an engagement tab54in various configurations. In the embodiment ofFIG. 11A, the engagement tab54is generally aligned with the clip outer wall46, so that the clip inner lumen48is generally unobstructed. InFIG. 11Bthe engagement tab54is positioned to extend partially into the lumen48, with the angle80between the engagement tab54and adjacent portion of the clip outer wall46being on the order of 45 degrees.FIG. 11Cdepicts the engagement tab54extending to a maximum extent into the clip lumen48, with the angle80between the engagement tab54and adjacent portion of the clip outer wall46being on the order of 90 degrees. Note that various angles80are within the scope of the invention, depending on the particular embodiment and such factors as the size of the suture, the size of the clip, the percentage of the inner lumen that is desired to be obstructed, the length of the engagement tab with respect to the inner diameter of the lumen, the bend added to the clip body44, etc.

FIGS. 12A-12Cdepict clips20having various lengths82of engagement tabs54. Although the embodiments ofFIGS. 12A-12Care all depicted as having an angle80of about 90 degrees, it is noted that other angles are within the scope of the invention, as discussed above with respect toFIGS. 11A-11C. InFIG. 12A, the engagement tab54A has a length82A equal to about 50% of the clip inner lumen diameter84. InFIG. 12B, the engagement tab54bhas a length82bof about 75% of the clip inner lumen diameter84, while inFIG. 12Cthe engagement tab54chas a length82cof about 100% of the clip inner lumen diameter84. Note that, as with the angle80, the engagement tab length82for a particular clip can vary depending on the particular application and still fall within the scope of the invention.

Note that the bending of the clip body44itself can effectively block a clip inner lumen, with or without engagement tabs such as those (54,54b,54c) depicted inFIGS. 12A-12C, etc.FIGS. 13A-13Band14A-14B depict a clip20having a hinge point55, but without tabs or other projections inside the inner lumen48. InFIGS. 13A-13B, the clip body44is in its straight or open configuration, without any bending about the hinge point55. The inner lumen48is seen inFIG. 13Bas being essentially open and unobstructed adjacent the hinge point55. InFIGS. 14A-14B, the clip20is in its bent or closed configuration, with a relatively sharp bend in the clip body44adjacent the hinge point55. The inner lumen48is seen inFIG. 14Bas being almost entirely blocked adjacent the hinge point55. Note that although a single hinge point55and associated bend is depicted inFIGS. 14A-14B, a suture clip according to the invention could include multiple hinge points and associated bends along the length of the suture clip.

FIGS. 15A-15Band16A-16B depict a clip having a hinge point55with inward-facing obstructions in the form of inner bumps86that extend into the clip inner lumen48at or adjacent the hinge point55. InFIGS. 15A-15B, the clip20is in the open configuration, with the inner lumen48being generally unobstructed adjacent the hinge point55except for minimal areas covered by the inner bumps84, as depicted inFIG. 15B, so that the inner lumen48has a size sufficient for suture to slidingly pass therethrough.FIGS. 16A-16Bdepict the same clip20in its closed configuration, wherein the clip body44is bent and has an almost flattened shape adjacent the hinge point55, as depicted inFIG. 16B. With the bumps86engaging against each other and/or the clip wall, the inner lumen48is generally obstructed adjacent the hinge point55so that suture lying within the inner lumen48will be held fast.

Clips can be formed from various biocompatible materials, including shape memory and/or pseudoelastic materials such as nitinol. In one embodiment a suture clip is formed from nitinol (such as an alloy of nickel at 54.5-57% by weight with titanium accounting for the balance except for residual amounts (less than 0.05% each) of oxygen, carbon, and hydrogen) or another shape memory and/or pseudoelastic material, with the suture clip formed so that the clip assumes its closed position (i.e., with the clip body in the bent configuration and the clip engagement tabs extending into the clip inner lumen) when in the austenite condition (i.e., when generally unstressed at body temperature). The nitinol can have an austenite finish temperature selected to match the particular application. In a medical suture clip, an austenite finish temperature of −5 degrees to +15 degrees Celsius may be selected.

A suture clip can be formed from material that will assume its martensite condition when subjected to sufficient stress, such as the stress applied to the clip engagement tabs54and clip body44when the suture clip20is mounted onto the device inner body distal end28, as depicted inFIG. 5A. In such an embodiment, the device inner body distal end28applies stress to the clip body44and clip engagement tabs54, forcing the clip body44to be straight and the clip engagement tabs54into general alignment with the clip outer wall46. The stressed material, including the bent material where the clip engagement tabs54meet the rest of the clip outer wall46, is forced into its martensite condition. Then the stress is removed, such as where the suture clip20is removed from the device10and device inner body distal end28as depicted inFIGS. 5B and 5C, the material returns to its austenite condition so that the clip body44assumes its bent shape and the clip engagement tabs54are biased inwardly to at least partially block the clip inner lumen48.

FIGS. 17-25illustrate an exemplary suture clip deployment device100. The device100can be loaded with one or more suture clips and can be used to deploy the suture clips onto sutures, such as during implantation of prosthetic device within the heart. The device100comprises a handle portion102that can be held and actuated by a user and a shaft portion104that can be inserted into the body, at least partially, to deploy suture clips onto sutures in hard to reach regions within the body in a minimally invasive manner. The device100can be used with any of the suture clips described herein or their equivalents, which are collectively referred to with the reference number130below.FIG. 17Ashows the device100with exemplary sutures131inserted into the distal end of the device.FIG. 17Bshows the shaft portion104of the device100with a suture131passing through an inner lumen of the device100with a free end of the suture projecting out through a lateral opening in the device, as describe in more detail below.

The handle portion102includes one or more actuation mechanisms that control functions of the device100. For example, the trigger106and associated mechanisms within the handle portion102can control a vacuum system either in the device100or remotely coupled to the device, and the lever108and associated mechanisms within the handle portion can control suture clip deployment, suture cutting, and/or advancement of remaining suture clips loaded on the device100.

As shown inFIGS. 18A-18F, the shaft portion104can comprise a main shaft or hypotube120, a vacuum tube122, a clip plow or pusher126, one or more clips130, an outer tube132, a clip guide138, a knife tube140, a suture door152, and/or other components. The shaft portion104is also shown assembled inFIGS. 23A-23F.

The hypotube120can be a tubular shaft having an inner lumen with distal opening, as shown inFIG. 18B. The clips130are mounted in axial alignment on the outer surface of a distal end portion of hypotube120, as shown inFIG. 18C. The device can be configured to be loaded with any number of clips130, such as up to 10 or 15 clips. As shown inFIG. 18B, the vacuum tube122can comprise a vacuum chamber124at a distal end. The vacuum chamber124is partially open on an upper side to expose a lumen within the vacuum tube122. A cross-sectional view of the vacuum chamber124and adjacent components is shown inFIGS. 23C and 23D. A distal end of the vacuum chamber124is attached to a proximal end of the hypotube120such that an inner lumen of the hypotube is in fluid communication with the inner lumen of the vacuum chamber122and the open portion at the vacuum chamber124. The suture door152can cover the vacuum chamber124to close off the opening and the inner lumen when a vacuum is applied to the inner lumen, as described below. When the suture door152is open, one or more sutures131drawn through the inner lumen from the distal opening of the hypotube120can be drawn out laterally from the inner lumen through the opening in the vacuum chamber124, as shown inFIG. 17B.

The clip plow126is positioned around the hypotube120and configured to drive the clips130distally along the hypotube120, as shown inFIG. 23E. The hypotube120passes between two split distal portions166of the clip plow, as shown inFIG. 18B, which are frictionally engaged with the outer surface of the hypotube120. This frictional engagement causes the clip plow126to tend to move axially along with movement of the hypotube120via the actuation mechanisms in the handle portion102unless the frictional engagement between the clip plow and the hypotube is overcome by another axial force on the clip plow.

The clip plow126is positioned within the clip guide138, as shown inFIGS. 18B and 23E. The clip guide138comprises a channel160in which the plow126, the hypotube120and the clips130travel axially. The channel160can include a keyed geometry that corresponds to the shape of a key portion168of the plow (seeFIG. 18B) to maintain rotational orientation. The channel160further comprises a plurality of grooves162on either side of the channel that are spaced apart axially about the length of one clips130. The grooves162engage with prongs164at the proximal end of the plow126to create a ratcheting mechanism that allows the plow126to move distally relative to the guide138but not proximally. When the hypotube120and vacuum tube122are moved distally by the actuation mechanism in the handle portion, the frictional engagement between the plow126and the hypotube120pulls the plow126distally. Because the prongs164have a sloped distal surface, the prongs164can flex inwardly and exit the grooves162of the guide132in response to the distal friction force exerted on the plow126by the hypotube120. When the prongs164disengage from the grooves162, the plow126can be pulled distally along the guide132by the hypotube until the prongs164reach the next pair of grooves162in the guide132, at which point the prongs164recoil outwardly into those grooves162. However, the prongs164can have blunt or otherwise not sloped proximal surfaces such that when the hypotube120is pulled proximally, the prongs164do not disengage from the grooves162and therefor prevent the plow126from moving proximally along with the hypotube120. This breaks the frictional engagement between the plow126and the hypotube120and allows the hypotube to move proximally relative to the plow126. In so doing, the plow126prevents the clips130from moving proximally along the hypotube120as the most proximal of the clips130abuts the distal end of the plow126. This breaks the frictional engagement between the clips130and the hypotube120and allows the hypotube to also move proximally relative to the clips130. In so doing, as distal end of the hypotube120can slide proximally out from within the most distal clip130, allowing that clip to resiliently return toward its natural crimped configuration and become secured onto one or more sutures131inserted into lumen of the hypotube120, as shown inFIG. 17A. The number of pairs of grooves162in the clip guide132can correlate to the maximum number of clips130that can be loaded into the device100. The device100is shown fully loaded with clips130inFIGS. 23C-23F, with the prongs164positioned in the most proximal pair of grooves162. The plow126can ratchet forward along the guide132one clip length after each clip130is deployed. The vacuum tube122, plow126, hypotube120, and clip guide138can all be fixed rotationally such that they maintain a fixed rotational alignment to one another and to the handle portion102.

The outer tube132can be positioned around the vacuum tube122and the clip guide138. A proximal end of the outer tube132can be fixed to the handle portion102via the adapter136(seeFIGS. 24 and 25) such that the outer tube132does not rotate or translate relative to the handle portion. The outer tube132can comprise a lateral opening134that is axially aligned with the opening in the vacuum chamber124to allow access to the inner lumen to draw out the free end of the suture, as shown inFIG. 17B.

As shown inFIGS. 18E and 18F, the shaft portion104can also include a knife portion140positioned around the outer tube132. The knife portion140also includes a lateral opening142that is axially aligned with the opening in the vacuum chamber124to allow access to the inner lumen to draw out the free end of the suture. The knife portion140can also comprise a cut-away distal end portion144and cutting blade146positioned at the distal end and oriented perpendicular to the longitudinal axis. When assembled, as shown inFIG. 17B, the blade146is positioned just distal to the distal end of the outer tube132and the distal end of the clip guide138. The blade146can cover more than 50% of the cross-sectional area of the knife portion140such that when the knife portion140rotates, the blade146shears across the distal end of the clip guide138can cuts any sutures passing into the inner lumen of the hypotube120, the distal end of which can be located just proximal to the distal end of the clip guide138. The knife portion140can further comprise a slot148located near the proximal end of the knife portion. The slot148can engage with the actuation mechanism of the handle portion102to allow the knife portion to be rotated. The adapter150can couple the proximal end of the knife portion140to the handle portion102to prevent axial motion of the knife portion (as shown inFIGS. 24 and 25).

The longitudinal axis of the hypotube120can be offset upward from the longitudinal axis shared by the vacuum tube122, the outer tube132, and the knife portion140. This allows the blade146to be positioned below the clips130and the suture when the knife portion is not actuated, and then allows the blade146to rotate across the axis of the suture and hypotube when the knife portion is actuated.

The suture door152can be mounted around the knife portion140in order to cover and uncover the vacuum chamber124and lateral openings134and142. The suture door152can be slidable along the outer surface of the knife portion140, either manually or via mechanical actuation, to selectively open and close the lateral access to the inner lumen of the vacuum tube122. When the suture door152in the closed position (e.g., inFIG. 17A) a low pressure can be maintain in the inner lumen of the hypotube120, allowing a suture131to be drawn into the distal opening of the hypotube. When the suture door152is moved to an open position (seeFIG. 17B), the vacuum in the hypotube is reduced as air can be drawn directly through the lateral openings142,134, through the vacuum chamber124and into the vacuum tube, bypassing the narrowing lumen of the hypotube. When the suture door152in the open position, a suture131drawn through the hypotube can be manually accessed and drawn laterally out through the lateral openings134,142, as shown inFIG. 17B. This can allow a user to grasp the free end of the suture131and adjust the tension in the suture prior to deploying a clip130onto the suture.

The handle portion102of the device100is shown inFIG. 17A(perspective view),FIGS. 19A-19C(exploded views),FIGS. 21-22(side and top views),FIGS. 23A-23B(cross-sectional top views), andFIGS. 24-25(cross-sectional side views). The handle portion102can comprise housing portions180that enclose most of the actuation mechanisms, provide a hand grip, and mounting locations for some other components of the device100.

In the illustrated embodiment, the proximal end of the vacuum tube122is coupled to a vacuum hose adapter184mounted within the housing180. A spring188is positioned around the vacuum hose adapter184and mounted within the housing such that the vacuum hose adapter184and the vacuum tube122can be actuated axially but prevented from rotating. The vacuum hose adapter184is coupled to a vacuum hose186, which can be coupled to an external vacuum source adapter112and/or be coupled to a vacuum source included within the housing180. A proximal end of the spring188abuts a collar stop190mounted in fixed position within the housing. The vacuum hose adapter184passes through the collar stop190and is fixed to a pivot collar192. The pivot collar192includes lateral pins198that pivotally engage openings196at one end of links194. Openings200at opposite ends of links194pivotally engage pivot pins202that extend fixedly from an upper portion of the lever108. Roller bearings208are rotatably attached to the ends of the pins202outside of the links194. The roller bearings208are positioned within horizontal slots206of plates204, which are mounted to the housing180.

The lever108can include a lower extension that protrudes outside of the housing and provides a manual actuation location. An upper portion of the lever108adjacent to the pins202can comprise opening212that is mounted around an intermediate portion of an anti-rotation pin210via one or more roller bearings216. The ends of the pivot pin210are slidably engaged in the notches214in the plates104.

The lever108can further comprise a slot234to the rear of and below the opening212. The slot234is mounted around a pin232that can slide transversely along the slot. The pin232is rotatably engaged with openings230at lower-rear end of respective links226on either side of the lever108. The lateral ends of the pin232are slidably engaged via roller bearings238within horizontal slots236in the plates204.

Openings228in upper-front ends of the links226are pivotally coupled to pins224of a knife actuator220, as shown inFIGS. 19C and 24. The pins224are also slidably engaged in horizontal slots225(FIGS. 24,25) in the housing180. The knife actuator220comprises a forward collar222positioned outside of the housing180and mounted around the knife portion140of the shaft assembly. The collar222includes a vertical pin223that extends downwardly into the slot148in the knife portion140.

The vacuum trigger106can be mounted to the housing180, such as via pivot axis242and spring arm243, such that depressing the trigger106mechanically and/or electrically controls the level of vacuum applied to the vacuum tube122. The vacuum trigger106can be used to initially draw a suture or sutures131into the hypotube and optionally out through the lateral openings134,142to tension the suture as desired. When the suture131is tensioned as desired and ready to be secured with a clip, the vacuum trigger106can be released and the lever108can be actuated.

When the lever108is pulled rearwardly relative to the housing180, the lever is initially prevented from pivoting due to the anti-pivot pin210being constrained in the notches214of the plates204. Thus, the lever108is initially only allowed to translate rearwardly about the length of one clip130. During this initial rearward translation, the pins202slide rearwardly along substantially the entire length of the slots206, which can be about the length of one clip130. The pin232also moves partially along the horizontal slots236in the plates204but does not translate along the vertical slot234in the lever yet. This initial horizontal translation of the lever108causes the links194to pull the vacuum hose adapter184rearwardly, compressing the spring188, and causing the vacuum tube122and hypotube120to also move proximally about the length of one clip130. The clip plow is held still due to the positive engagement of the prongs164in the notches162, and the hypotube is pulled out from within the most distal clip130, causing the clip to deploy off the hypotube and onto a suture.

Also during the initial horizontal translation of the lever108, the links226move rearwardly and pull the knife trigger220rearwardly about the length of a clip130. This causes the pin223in the collar222to move proximally along an axial portion170of the slot148(seeFIG. 18E). As the pin223moves along the axial portion170of the slot148, the knife portion140is not caused to rotate. However, subsequent proximal movement of the pin233along the helical portion of the slot148causes the knife portion140to rotate and cut the suture after a clip130is deployed.

The subsequent proximal movement of the pin223can be caused by further pulling of the lever108. After the initial rearward translation, the anti-rotation pin210exits the notches214as is free to move upwardly and rearwardly. This allows the lever108to begin to rotate about the pins202while the slots206prevent the lever from translating any further rearwardly. As the lever pivots about the pins202, the pin232continues to translate rearwardly along the slots236of the plates204and being translating along the slot234in the lever108. As the pin232translates further rearwardly, it pulls the links226further rearwardly, which pulls the knife trigger220further rearwardly, causing the pins224to slide rearwardly along the slots226and causing the collar222and pin223to move further rearwardly, which rotates the knife portion140, as discussed above.

After the knife portion140is sufficiently rotated to cut the suture131, the lever108can be released. A spring240can be attached between the housing and the lever108(e.g., at the point241) to cause the lever to rotate back to the point where the anti-rotation pin210reaches the plates204, and then the spring188can urge the lever108to translate forward as the anti-rotation pin210re-enters the notches214and the actuation process reverses itself.

As the lever translates forward, the vacuum tube122and hypotube120move distally. The clip plow126and clips130also move distally the same amount, about the length of one clip130, and the prongs164move up one notch in the clip guide138such that the next clip is ready to be deployed the next time the lever is pulled.

In some embodiments, the device100can comprise a clip monitoring system that tracks/determines and displays the number of clips remaining loaded in the device. The device can comprise a display, such as a rear display114(seeFIGS. 21-22), that shows how many clips remain. In some embodiments, when the last clip has been deployed, the clip monitoring system can cause the device to become locked such that lever108cannot be pulled. In some embodiments, the clip monitoring system can also display a lock-out indicator on the display. The display can be mechanical or electronic, analog or digital.

In some embodiments, the device can comprise a suture tension monitoring system that includes a sensor to measure tension in the suture and a display, such as the display114or otherwise, that shows a tension value, such as in pounds or Newtons.

In some embodiments, the device can comprise a vacuum monitoring system that determines and displays the pressure in the inner lumens and/or the amount or status of vacuum being generated or applied from a vacuum source. In some embodiments, an indicator on a display can indicate simply whether the vacuum is being applied, while in other embodiments, a level of vacuum or pressure can be displayed.

The embodiment shown inFIG. 25includes an internal vacuum source250mounted within the housing. The internal vacuum source250can be used in lieu of an external vacuum source or as a secondary option to an external vacuum source. In some embodiments, the internal vacuum source250can be coupled to the vacuum house adapter184that is separate from the hose186shown, and in other embodiments, a forked hose can be used the branches to both internal and external vacuum sources. A switch252, shown inFIG. 25, can be used to switch between the external vacuum source and the internal vacuum source250. The internal vacuum source250can be powered by a battery source housed within the handle portion102. If the battery dies, for example, the switch252can be used to switch to an external vacuum source. Conversely, the user can switch from an external vacuum source to the battery powered internal vacuum source250. The battery can also power the monitoring systems and displays discussed above.

In some embodiments, the device100can be disposable after being used during a surgery and/or when all the loaded clips have been deployed. In other embodiments, the device100can be cleaned and reloaded with clips and reused. This can include moving the clip plow126back a more proximal position in the clip guide138.

FIG. 26shows another exemplary suture clip deployment device300. The device300includes a handle302, an outer tube304, and an inner tube306. A suture clip322(which can comprise any of the clips disclosed herein or equivalents) can be loaded onto a distal end portion of the inner tube306, which extends about one clip length past the distal end of the outer tube304. A free end of a suture or sutures334can be threaded through a lumen of the inner tube306and out through a lateral port307,308that passes through both the inner tube306and the outer tube304. The lateral port can comprise a slot307in the sidewall of the inner tube306and a slot308in the sidewall of the outer tube304that are aligned prior to actuation. A user can then grasp the free end of the suture324projecting out from the lateral port and apply a desired tension before deploying the clip322onto the suture.

An actuation mechanism320can then be manually actuated (e.g., pulled proximally) to cause the inner tube306to move proximally relative to the loaded clip322in order to deploy the clip off the distal end of the inner tube306onto the suture324. As the inner tube306moves proximally relative to the outer tube304, the distal end of the outer tube304can abut the clip322and force the clip to move distally relative to the retracting inner tube306.

Further, as the inner tube306moves proximally relative to the outer tube304, the slot308in the outer tube move across the slot307in the inner tube and can thereby cut or shear off a free end of a suture324that extends out through the port after that clip has been deployed onto the suture. The slot308in the outer tube and/or the slot307in the inner tube can be sharpened to help cut the suture324. In some embodiments, the distal end of the inner tube can be sharpened or include a blade to cut off the free end of the suture324just proximal to where the clip322is deployed onto the suture.

The handle302can have any configuration, such a gun handle configuration like the device100. The handle302houses the actuator320and optionally a spring to urge the actuator to return to the forward position after it is pulled rearward to deploy a clip322. The handle302can further include various ports and/or displays, such as for the systems described below.

In some embodiments, the device300can include a vacuum system for drawing a suture into the inner tube, while the device300does not include a vacuum system in other embodiments. In embodiment including a vacuum system, the device300can optionally include an internal vacuum source and/or can include a connector for coupling the device to an external vacuum source.

In some embodiments, the device300can include a tension monitoring system, a clip monitoring system, a vacuum monitoring system, and/or a display similar to those described with regard to the device100.

In some embodiments, the device300can include a lighting system. The lighting system can comprise one or more light conductors, such as optical fibers310, that transfer light from a light source to near the distal end of the outer tube304. The light source can be external to the device300or can be included in the handle302as part of the device300. As shown inFIG. 26, the fibers310can extend through the handle302and through an extension arm311to an adaptor312configured to be coupled to an external light source314. In some embodiments, the fibers310can be positioned between the inner tube306and the outer tube308, as shown in the cross-sectional view ofFIG. 27. In other embodiments, the light fibers can be positioned between the outer tube304and another tube (not shown) surrounding the outer tube and the light fibers in order to isolate the light fibers from the motion between the inner and outer tubes. The distal ends of the fibers310can provide light near the clip deployment location within otherwise dark regions within the body to assist the user during the clip deployment process. Some embodiments of the device100can similarly include such a lighting system.

In some embodiments, the device300can include a visual monitoring system configured to capture visual information from the near the distal end of the outer tube304and transfer the captured visual information to a proximal visual display. For example, the device300can include a camera or endoscope positioned near the distal end of the outer tube304that is coupled via wiring to an adaptor316extending from the handle302and configured to be coupled to an external monitor that a user can view to assist in the clip deployment process. Some embodiments of the device100can similarly include such a visual monitoring system as well.