Tissue anchors and medical devices for rapid deployment of tissue anchors

Medical devices and related methods are provided for closing a perforation in a bodily wall. The medical device generally includes a set of tissue anchors and an elongate tensioning member. Each anchor includes a crossbar having opposing ends and defining a longitudinal axis. A strand is connected to the crossbar at a location between the opposing ends and projects away from the longitudinal axis. The strand includes a distal end connected to the crossbar and a proximal end having a first connector. The elongate tensioning member is structured to selectively engage and disengage the first connector. The strands of the anchor are capable of being tensioned and fixed together for closing the perforation. The tensioning member is removed after the strands are fixed together.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and more particularly relates to tissue anchors for closing perforations in tissue.

BACKGROUND OF THE INVENTION

Perforations in bodily walls 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 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, and thereafter cut and removed from within the patient's body.

Manually tying suture 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 and cutting sutures are well documented. In order to address these and other issues of manual suture tying and cutting, 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.

BRIEF SUMMARY OF THE INVENTION

The present invention provides tissue anchors, as well as related devices and methods, for closing perforations in bodily walls. The tissue anchors are simple and reliable in use, facilitate perforation closure, and are adaptable to a variety of perforation closure situations. One embodiment of a tissue anchor, structured for engagement with a tensioning member, for closing a perforation, constructed in accordance with the teachings of the present invention, generally comprises a crossbar and a strand. The crossbar has first and second opposing ends and defines a longitudinal axis. The strand is connected to the crossbar at a location between the opposing ends. The strand has a length in the range of about 5 mm to about 50 mm extending from a distal end connected to the crossbar to a proximal end having a first connector. The strand and its first connector project away from the longitudinal axis.

Another embodiment of the present invention includes a medical device for closing a perforation. The medical device generally comprises a set of tissue anchors and an elongate tensioning member. Each tissue anchor includes a crossbar and a strand. The crossbar has first and second opposing ends and defines a longitudinal axis. The strand is connected to the crossbar at a location between the opposing ends and projects away from the longitudinal axis. A distal end of the strand is connected to the crossbar and a proximal end of the strand includes a first connector. The elongate tensioning member is structured to selectively engage and disengage the first connector. The strands are capable of being tensioned and fixed together for closing the perforation.

According to more detailed aspects of this embodiment of the medical device, the strand has a length in the range of about 20 mm to about 30 mm.

A method for closing a perforation in a bodily wall of a patient is also provided in accordance with the teachings of the present invention. A medical device, such as the device described above, is provided. Each tissue anchor is passed through the bodily wall adjacent the periphery of the perforation such that the crossbar of each tissue anchor is on a distal side of the bodily wall and the first connector of each tissue anchor is on a proximal side of the bodily wall for selectively engaging and disengaging the elongate tensioning member. The elongate tensioning member engages with the first connector of each strand and the elongate tensioning member is manipulated to position the strands close to one another. The strands are secured together on the proximal side of the bodily wall. The elongate tensioning member disengages from the first connector and is removed from within the patient.

DETAILED DESCRIPTION OF THE INVENTION

Turning now to the figures,FIG. 1adepicts a tissue anchor20constructed in accordance with the teachings of the present invention. The anchor20is utilized for closing a perforation10in a bodily wall12(FIGS. 5-7). The anchor20may also be used for apposing tissue, for example, in gastroesophageal reflux disease (GERD) therapy, or bariatric surgery in which an anastomosis is formed, or for use in other procedures. The anchor20generally includes a crossbar24having opposing ends26and28and defining a longitudinal axis22. A flexible strand30is connected to the crossbar24at a location between the opposing ends26and28of the crossbar24. The strand30includes a distal end32connected to the crossbar24and extending away from the longitudinal axis22of the crossbar24to a proximal end34which terminates in a connector36, discussed in further detail below.

The crossbar24is preferably elongated, but may take any form suitable for closing the perforation10in the bodily wall12, including rods, tubes, disc shapes or other elongated or planar shaped members. The crossbar24is preferably formed of a tubular cannula, although the crossbar24may be a solid cylinder, a metal bar, a plastic molded piece, or any stock materials. The strand30is preferably formed from a flexible suture material, although the strand30can have other constructions such as a metal wire, including single filament and multi-filament wires, and wound and braided wires, plastic strings, rope and the like.

It will be recognized by those skilled in the art that the strand30may be secured to the crossbar24using any now known or hereinafter developed attachment means, including mechanical fasteners, adhesives or various welding or soldering techniques. In one preferred construction, the crossbar24is formed of a cannula having an opening formed therethrough between opposing ends26and28and the distal end32of the strand30is received within the opening in the cannula and crimped in place. Alternatively, the strand30may be unitarily and integrally formed with the crossbar24as a single piece. Accordingly, the entire tissue anchor20may be formed of a single plastic or metal material, and most preferably a resorbable material. For example, the anchor20, including the crossbar24and strand30, may be injection molded of a permanent material, such as nylon, or a resorbable material. The material of the anchor20could also be made radiopaque or echogenic, e.g., by embedding particles within the plastic or selecting a suitable material having inherent or formed radiopaque or echogenic properties.

As used herein, the term “resorbable” refers to the ability of a material to be absorbed into a tissue and/or body fluid upon contact with the tissue and/or body fluid. A number of resorbable materials are known in the art, and any suitable resorbable material can be used. Examples of suitable types of resorbable materials include resorbable homopolymers, copolymers, or blends of resorbable polymers. Specific examples of suitable resorbable materials include poly-alpha hydroxy acids such as polylactic acid, polylactide, polyglycolic acid (PGA), or polyglycolide; trimethlyene carbonate; polycaprolactone; poly-beta hydroxy acids such as polyhydroxybutyrate or polyhydroxyvalerate; or other polymers such as polyphosphazines, polyorgano-phosphazines, polyanhydrides, polyesteramides, poly-orthoesters, polyethylene oxide, polyester-ethers (e.g., poly-dioxanone) or polyamino acids (e.g., poly-L-glutamic acid or poly-L-lysine). There are also a number of naturally derived resorbable polymers that may be suitable, including modified polysaccharides, such as cellulose, chitin, and dextran, and modified proteins, such as fibrin and casein.

The strand30preferably has a length in the range of about 5 mm to about 50 mm, and most preferably about 20 mm to about 30 mm. The strand30preferably has a diameter less than about 50% of a diameter of the crossbar24, and most preferably less than about 35%. The strand30preferably has a diameter in the range of about 0.20 mm to about 0.35 mm, and most preferably about 0.254 mm. The crossbar24preferably has a diameter in the range of about 0.5 mm to about 1.0 mm, and most preferably about 0.8 mm. The crossbar24typically has a length in the range of about 3.0 mm to about 10.0 mm. The crossbar24and/or the strand30may be coated with a low-friction material such as known plastic or hydrophilic coatings.

As illustrated inFIG. 1a, the connector36most preferably takes the form of an eyelet or closed loop at the proximal end34of the strand30. The closed loop connector36preferably has a diameter in the range of about 0.5 mm to about 1.5 mm. The connector36can have an alternative shape, such as that depicted inFIG. 1b.FIG. 1bdepicts an embodiment of a tissue anchor220in accordance with the teachings of the present invention and having a description similar to that ofFIG. 1a, and in which similar components are denoted by similar reference numerals increased by200. In this embodiment, the connector236takes the form of a J-shaped hook.

The connector36is structured to receive a tensioning member38(FIGS. 2a-c) for aiding in deployment of the anchor20. The connector36may be formed from a flexible suture material, metal wire, plastic, rope or any suitable resorbable material. As shown inFIG. 1a, the closed loop connector36is preferably formed integrally with the strand30. The closed loop connector36is flexible and is capable of stretching or adjusting its shape and orientation when tensioned by the tensioning member38. Alternatively, the connector36may be formed from a different material than the strand30, may have a greater thickness than the strand30, and may be secured to the strand30using any suitable means, including mechanical fasteners, tying, bonding, welding, or adhesives. For example, in order for the J-shaped hook connector236ofFIG. 1bto maintain its shape when tensioned by a tensioning member, the connector236is preferably made of a stronger, more rigid material than the strand230such as a rigid plastic or metal material. In addition, the connector36preferably has a smooth, rounded shape so that the anchor20is atraumatic to other surrounding tissues.

Turning now toFIGS. 2a-c, a pair of tissue anchors20aand20bis depicted with various embodiments of tensioning members38,138, and238configured to selectively engage and disengage the connectors36. As depicted inFIG. 2a, the tensioning member38includes a suture52in combination with an elongate holding member40. The suture52and elongate holding member40ofFIG. 2aare shown in use with anchors20aand20bhaving connectors36in the form of a closed loop, as depicted in the embodiment ofFIG. 1a.

The suture52includes first and second ends54and56which are preferably located and maintained outside of the body. The first and second ends54and56can be fixed within a handle (not shown) at a proximal end of the tissue anchor delivery device (FIG. 4), for example, by a tuohy borst connector or clamp. The suture52is preferably pre-loaded through the closed loop connectors36such that a section of the suture52is pulled through each of the closed loops connectors36and maintained by the elongate holding member40. Thus, the suture52preferably passes through each closed loop connectors36twice to form folded over looped sections58and60. These folded over looped sections58and60are of a sufficient length to provide adequate slack in the suture52during distal advancement and separate positioning of the tissue anchors20aand20b.

As depicted inFIG. 2a, the suture52extends from the first end54and is folded over to form the first looped section58; the suture52extends from the first looped section58and is folded over to form the second looped section60; and the suture52extends from the second looped section60to the second end56. The first looped section58is slidably received within the closed loop connector36of the first anchor20aof the pair of anchors and the second looped section60is slidably received within the closed loop connector36of the second anchor20bof the pair of anchors. The elongate holding member40includes a proximal end42and a distal end44terminating with a connector46structured to selectively engage and disengage the first and second looped sections58and60of the suture52. The suture52may be of a single filament or multi-filament constructions and preferably has a diameter in the range of about 0.20 mm to about 0.35 mm.

It will be recognized by those skilled in the art that the connector46may take on any suitable shape or form suitable for selective engagement and disengagement with the looped sections58and60. Preferably, the connector46at the distal end44of the elongate member40is hook shaped, e.g., a J-shaped hook as shown.

As depicted in the alternate embodiment ofFIG. 2b, the tensioning member138includes a suture152having first and second ends154and156which extend through the tissue anchor delivery device and are located and maintained outside of the body proximate a proximal end of the delivery device for manipulation by the physician. In this embodiment, the suture152extends from the first end154through the first and second closed loop connectors36of the pair of anchors20aand20b, respectively. The tensioning member138including the suture152may be used in conjunction with anchors having connectors other than the closed loop connectors36illustratedFIG. 2b. For example, the suture152may selectively engage hooked connectors, such as the J-shaped hook connector236illustrated inFIG. 1b, in which the suture152would be threaded through the hooked connector236. The suture152may be of a single filament or multi-filament constructions.

As depicted in the alternate embodiment ofFIG. 2c, the tensioning member238includes an elongate holding member240having a proximal end242and a distal end244terminating with a connector246structured to selectively engage and directly disengage the first and second closed loop connectors36of the pair of anchors20aand20b, respectively. Preferably, the connector246at the distal end244of the elongate member240is a J-shaped hook. The elongate holding member240having the connector246may be used in conjunction with anchors having connectors other than the closed loop connectors36illustrated inFIG. 2c. For example, the connector246of the holding member240may selectively engage a hook shaped connector, such as the J-shaped hooked connector236ofFIG. 1b. It will be recognized by those skilled in the art that the connector246may take on any suitable shape or form suitable for selective engagement and disengagement with the various connectors36. For example, the connector246could be a ringlet or closed loop, while the connectors36could be hook shaped (seeFIG. 1b). These and other variations will be readily apparent to the skilled artisan.

Turning now toFIGS. 3 and 4, the tissue anchors20are preferably deployed as a set of anchors including at least two anchors20aand20b. The tensioning member38aids in positioning the anchors20aand20bduring delivery of the anchors20aand20bthrough tissue of the bodily wall12and is removed thereafter, as will be described in more detail below. As best seen inFIG. 3, the crossbars24of the anchors20aand20bare positioned on a distal side of the bodily wall12, while the majority of the strands30connected to the crossbars24, including the connectors36, are positioned on a proximal side of the bodily wall. After the anchors20aand20bare positioned through the tissue of the bodily wall12, the strands30of the anchors20aand20bare brought together, via the tensioning member38, and fixed in place, via a suture lock62, in order to close the perforation10. Thereafter, the tensioning member38is removed. Thus, rather than employing a separate suture or a plurality of individual sutures to fix the anchors to the bodily wall (which must be fixed in place in order to close the perforation, and thereafter manually cut and removed) the anchors20aand20bare fixed together directly, via the strands30and the suture lock62. Thus, the construction of the anchors20aand20b, including strands30with connectors36, alleviates the many difficulties associated with manually cutting sutures used to fix the anchors together.

Referring toFIG. 4, a medical delivery device100for employing the anchors20aand20band the lock62, in accordance with the teachings of the present invention, includes a needle86having a needle lumen88sized to slidably receive the tissue anchors20aand20b. Preferably, a resorbable spacer member50is positioned between the anchors20aand20bwithin the needle lumen88near the distal end89of the needle86. The needle86includes a needle slot87sized to receive the strands30of the anchors20aand20b. The medical delivery device100may include a set of more than two anchors and more than one spacer members. The longitudinal length of the needle slot87is dependent upon the number of anchors and the length of the crossbars and the number of spacer members positioned between the anchors and the length of the spacer members such that the needle slot87is capable of receiving the strands30connected to each of the crossbars24positioned within the needle lumen88. A pusher98is slidably received within the needle lumen88to engage the proximal-most anchor, the anchor20binFIG. 4, and deploy the anchors20aand20b, and the spacer member50positioned therebetween, from the delivery device100.

The medical device100further includes an inner sheath90having a lumen92sized to slidably receive the needle86and an outer sheath94having a lumen96sized to slidably receive the inner sheath90. The strands30of the anchors20aand20bextend away from the longitudinal axis22of the crossbars24of the anchors20aand20b, through the needle slot87and proximally within the outer sheath lumen96. A tensioning member38, in accordance with the teachings of the present invention, is slidably received within the outer sheath lumen96to selectively engage and disengage the connectors36of the strands30of the anchors20aand20b. While the tensioning member38ofFIG. 2a, including the suture52and the elongate holding member40, is illustrated as part of the medical delivery device100inFIGS. 4-9, the tensioning members138or238ofFIGS. 2band2c, respectively, may be employed as part of the medical delivery device100. Similarly, the anchor220ofFIG. 1bhaving a J-shaped connector236may be delivered using the medical delivery device100in accordance with the teachings of the present invention.

The inner and outer sheaths90and94are preferably formed of a plastic such as polytetrafluorethylene (PTFE), expanded polytetrafluorethylene (EPTFE), polyethylene ether ketone (PEEK), polyvinylchloride (PVC), polycarbonate (PC), polyamide including nylon, polyimide, polyurethane, polyethylene (high, medium or low density), or elastomers such as Santoprene®, including multi-layer or single layer constructions with or without reinforcement wires, coils or filaments. The needle86, inner and outer sheaths94and90, the pusher98, and the tensioning member38, including the suture52and the holding member40, are preferably elongated structures that are flexible, allowing navigation within a patient's body such as during endoscopic or laparoscopic procedures. As such, a suitable handle or control mechanism will be connected to the proximal ends of the needle86, sheaths90and94, and pusher98for relative translation of these components by the medical professional, as is known in the art.

Preferably, the medical device100further includes an over-the-needle suture lock62for fixing the strands30of the anchors20aand20bafter delivery of the anchors20aand20bthrough the bodily wall12. An over-the-needle suture lock62, in accordance with the teachings of the present invention, allows the strands30of the set of anchors20aand20bto be preloaded within the suture lock62during delivery of the anchors20aand20bthrough the bodily wall12. The suture lock62generally includes a locking pin or plug64and a retaining sleeve66which cooperate to fix the strands30of the anchors20aand20brelative to tissue of the bodily wall12for closing the perforation10in the bodily wall12. The retaining sleeve66and plug64may have a circular cross-section, or any other cross-sectional shapes including triangular, square, etc.

As best seen inFIGS. 4-9, the retaining sleeve66generally includes a tubular body68having an interior surface69defining an interior passageway70. A peripheral rim72is formed at a distal end of the tubular body68, and defines a shoulder74which is used for placement of the retaining sleeve68, as will be discussed in further detail herein. Generally, the retaining sleeve68receives the strands30of the anchors20aand20bwithin the interior passageway70. The strands30are then fixed in place using the plug64, which is designed to fit within the passageway70and pinch or compress the strands30of the anchors20aand20b. It will also be recognized that the plug64may have many configurations (e.g. regular or irregular shapes), and constructions (e.g. cast, molded, machined, wound (such as with wire), etc.) so long as a portion of the plug64cooperates with the retaining sleeve66to fix the strands30. Preferably, the plug64and the retaining sleeve66are formed from stainless steel or any other suitable metal or plastic material known in the art.

As best seen inFIGS. 4-9, the plug64generally includes a main body76having an interior surface77defining an interior passageway78sized to slidably receive the needle86. The main body76includes a grip80and a stop82, each extending radially from the main body76. In the illustrated embodiment, the grip80is formed at a distal end of the plug64, although it could be moved proximally along the length of the main body76. The grip80defines an annular edge79that is used to engage the strands30of the anchors20aand20b. The stop82is longitudinally spaced from the grip80and is used to control the position of the plug64within the retaining sleeve66. The stop82generally includes a proximally facing surface83defining a shoulder84which is used to position the plug64. The stop82is positioned relative to the grip80to prevent the grip80from passing completely through the internal passageway70of the retaining sleeve66. While the length of the strands30of the tissue anchors20is preferably between about 5 mm and 50 mm, the length of the strands30should be such that the connectors36of the strands30exit the suture lock62to provide sufficient engagement of the strands30between the plug64and retaining sleeve66.

As depicted inFIGS. 4-7the inner sheath90is sized and positioned to abut the shoulder84of the plug64and the outer sheath94is sized and positioned to abut the shoulder74of the retaining sleeve66. Translation of the inner sheath90relative to the outer sheath94causes the plug64to slide over-the-needle86and to be received within the passageway78of the retaining sleeve66to engage the strands30of the anchors20aand20bbetween the main body76of the plug64and the interior surface77of the retaining sleeve66to fix the strands30.

Further details of the needle assembly and the over-the-needle suture lock62may be found in U.S. Provisional Application No. 61/166,361 entitled “Medical Devices, Systems, and Methods for Rapid Deployment and Fixation of Tissue Anchors” to Ducharme, the entire contents of which are incorporated by reference herein.

The medical device100may be sized to be used through an accessory channel of an endoscope or alongside an endoscope, or in combination with other devices used in conjunction with endoscopes, for example, endoscopic suction devices or fluid injection devices.

A method of closing the perforation10, in accordance with the teachings present invention, includes passing each tissue anchor20aand20bthrough the tissue of the bodily wall12adjacent the periphery of the perforation10, as shown inFIGS. 5-7. Preferably, the anchors are sequentially positioned around the perforation10. As shown, the anchors20aand20bare positioned on opposing sides of the perforation10. As previously noted, a plurality of anchors including more than the two anchors20aand20bmay be sequentially positioned around the perforation10.

As illustrated inFIG. 5, the medical delivery device100, in accordance with the teachings of the present invention, is delivered to a position proximate the tissue of the bodily wall12. The anchors20aand20bare disposed within the needle lumen88at the distal end89of the needle86and a resorbable spacer member50is disposed between the anchors20aand20b. Spaces between the spacer member50and the anchors20aand20bhave been shown for clarity, but the spacer member50and the anchors20aand20bwould generally be abutting end-to-end within the needle lumen88. The strands30of the anchors20aand20bare received within the needle slot87and project away from the longitudinal axis22of the anchor crossbars24. Preferably, the needle86is slidably received within the inner sheath lumen92, and the tensioning member38is pre-engaged with the connectors36of the anchor strands30extending from the needle lumen88, prior to being slidably received within the outer sheath lumen96. Thus, the needle86within the inner sheath90and the tensioning member38are preferably pre-engaged and loaded into the outer sheath94together and advanced toward a distal end95of the outer sheath96prior to positioning of the medical delivery device100. Thus, as depicted inFIGS. 4-7, the tensioning member38is disposed within the outer sheath lumen96and is in selective engagement with the connectors36of the strands30of the anchors20aand20b.

The method illustrated inFIGS. 5-7depicts a medical delivery device100including, as an example, the tensioning member38ofFIG. 2a. In this example, once positioned near the distal end95of the outer sheath96, the elongate holding member40maintains its hold on the connectors36of the anchor strands30via the first and second looped sections58and60of the suture52. The first and second ends54and56of the suture52are preferably maintained within a proximal handle (not shown) of the device100while the physician maintains a hold of and manipulates the elongate holding member40. The folded over looped sections58and60are preferably of a sufficient length to provide adequate slack in the suture52during separate positioning of the tissue anchors20aand20b.

As illustrated inFIG. 5-6, the needle86is deployed through the tissue of the bodily wall12by translating the needle86relative to the inner and outer sheaths90and94. The distal-most tissue anchor, the anchor20ainFIGS. 4-5, is then deployed from the needle86by translating the anchor20arelative to the needle86so that the anchor20aexits the needle lumen88. As shown inFIGS. 4-5, the anchors20aand20b, and the spacer member50positioned therebetween, are shown aligned within the needle lumen88along a longitudinal axis of the needle lumen88such that the pusher98may be slidably received within the inner sheath lumen92and used to engage and press on the proximal-most anchor, anchor20binFIGS. 4-7, which will in turn transmit force through the spacer member50and the distal-most anchor20a, thus advancing the distal-most anchor20aout of the needle lumen88. As the anchor20aexits the needle lumen88, the strand30of the anchor20ais released from the needle slot87.

Accordingly, it will be recognized that a large number of tissue anchors and spacer members may be employed within the medical device100, and the longitudinal length of needle slot87can be sized to accommodate any number of anchor strands30. In this manner, the medical device100need not be withdrawn to be reloaded. The method may therefore include withdrawing the needle86from the bodily wall by translating the needle86proximally, and then repeating the steps of translating the needle86through the tissue12and deploying a tissue anchor therethrough.

Turning toFIG. 7, the needle86is retracted back through the bodily wall12by translating the needle86proximally, repositioned at a different position about the perforation10, and redeployed back through the tissue of the bodily wall12by translating the needle86relative to the inner and outer sheaths90and94. The pusher98is then further advanced distally to deploy the spacer member50and the proximal anchor20b, wherein the strand30of the anchor20bis released from within the needle slot87. The spacer member50is then resorbed within the patient's body.

After the anchors20aand20bare deployed on the distal side of the bodily wall12, the needle86is retracted back through to the proximal side of the bodily wall12and removed from within the inner sheath lumen92. The elongate holding member40is used to tension the strands30of the anchors20aand20bto bring the strands30together to close the perforation10. Preferably, the elongate holding member40is retracted, applying a pulling force on the first and second looped sections58and60of the suture52, which in turn applies a pulling force on the connectors36, thus tensioning the strands30of the anchors20aand20bto reduce the distance between the anchors20aand20band compress the bodily wall12around the perforation10, as depicted inFIGS. 8 and 9.

As best seen inFIG. 9, the strands30of the anchors20aand20bare secured to maintain the compression of the bodily wall10, such as through the use of a suture lock. Preferably, the stands30are fixed through the use of an over-the-needle suture lock62, in accordance with the teachings of the present invention, described in detail above and illustrated inFIGS. 4-9. Alternatively, other suture locks may be employed to fix the strands30, such as the suture locks disclosed in copending U.S. patent application Ser. Nos. 12/125,525 and 12/191,001, the disclosures of which are incorporated herein by reference in their entirety. It will be recognized that any now known or future developed method for securing the strands30of the anchors20aand20bmay be employed, such as knotting, tying, clamps, rivets and the like. After the anchors20aand20bhave effectively closed the perforation10in the bodily wall12and the stands30are secured, the delivery device100, including the tensioning member38, is removed from within the patient. In the example inFIGS. 8-9, the holding member40is unhooked from the first and second looped sections58and60and the suture52is removed by opening or releasing the tuohy borst connector or clamp of the proximal handle of the delivery device and pulling one end of the suture52while releasing the opposing end of the suture. In this manner, the suture52slides through the closed loop connectors36as it is removed from the patient.