[0001] The disclosed invention relates generally to devices used to secure sutures. More particularly, the invention relates to suture clips and suture clip delivery devices used in conjunction with sewing devices used in flexible endoscopy; though it is also applicable to devices used in rigid endoscopy.
[0002] It is estimated that as many as 15,000,000 individuals in the United States suffer from stomach acid reflux into the lower esophageal region, commonly referred to as GERD (gastroesophageal reflux disorder). Although the illness may result from a wide variety of causes, it is ultimately the failure of the cardiac sphincter located above the stomach that enables a reflux event to occur. A surgical method developed to reduce reflux episodes involves forming tissue folds in the walls of the stomach to reduce the cross-sectional area of the gastroesophageal juncture to mimic the function of the cardiac sphincter. To perform these types of procedures, sewing devices used to suture the stomach wall into folds are used. The procedure typically involves a fiber optic endoscope introduced into the lower esophageal area. A sewing instrument is advanced down the working channel of the endoscope that has an aspiration port for generating negative pressure to suction stomach wall tissue into the sewing instrument where one or more sutures are implanted to hold the suctioned tissue in a folded condition known as a plication.
[0003] Sewing devices for this procedure are described in, for example, GB-A-2165559 and U.S. Pat. No. 5,080,663. According to these references, a sewing device is used for passing a thread through a tissue fold. The sewing device comprises a hollow needle movable between a first pre-tissue penetration position and a second position in which it passes through the tissue, with a thread carrier adapted to be attached to the thread and being receivable within the hollow needle.
[0004] Preferably, the sewing device comprises a body that defines a cavity within which the substrate portion can be held, for example, by means of suction. The hollow needle is mounted for movement in the body between the first and second positions. In some versions of the procedure, a suture is inserted into the tissue with a needle, the two ends of which are fed back out of the patient. Typically, a physician fashioned a series of half hitches to secure the suture to the subject tissue.
[0005] In other embodiments of the procedure, a tag attached to a distal end of the suture and contained within a lumen of the needle is inserted into and past the tissue. With the needle in an advanced position, i.e., with the needle distal tip extending distally beyond the pierced tissue, a pusher forces the tag out of the needle. After retraction of the needle from the tissue, the suture is retracted so that the tag contacts the tissue. The tag functions as an anchor that enables the suture to be secured to the tissue from the proximal end and also disperses the force applied to the tissue by the suture to prevent tearing of the tissue. Such a device and procedure is described in U.S. Pat. No. 5,080,663 to Mills et al., the contents of which are incorporated herein by reference.
[0006] One of the significant problems associated with these procedures is the time and number of intubations needed to perform the various procedures endoscopically. Due to a number of concerns, a patient is typically anesthetized for no more than approximately 40 minutes. In this period of time, procedures such as the GERD procedure must be performed to completion. In the GERD procedure, several intubations are performed to create several plications. As many as nine intubations are required to create just one plication. This is the case when half hitches are used to secure the suture. Each half hitch requires the hitch to be made outside the endoscope and then advanced down the endoscope with a pusher. Typically, six half hitches are used per suture thus six intubations are needed to secure the half hitches. The time needed for each intubation substantially reduces the working time to complete a GERD procedure.
[0007] One approach to solving this problem is disclosed in U.S. Pat. No. 5,584,861 to Swain. The Swain patent discloses a suture clip and suture clip delivery device that is used in place of half hitch knots. The disclosed suture clip is a cylinder with a plug that can be releasably secured in the cylinder. The disclosed suture clip delivery device includes a tube, the distal end of which has a recess for receiving the suture clip. An axially movable stirrup is provided at the distal end that has the capacity to be moved from a first position that secures the suture clip to the tube and a second position that allows for the suture clip to be removed from the recess.
[0008] An aperture is provided in the cylinder to receive the suture. The cylinder is advanced over the suture that exits from a proximal end of the cylinder and enters the tube. An aperture in a sidewall of the tube provides egress for the suture. The plug is then advanced down the tube and into the cylinder. The interfacing walls of the cylinder and plug capture the suture. A pusher is used to force the plug into the cylinder while the stirrup maintains the suture clip in the recess. Following plug insertion, the stirrup, which is offset from the center axis of the tube, is advanced distally from the distal end of the tube to release the suture clip from the tube.
[0009] Although the Swain device solves the problem of multiple half hitches, the overall design of the device has certain drawbacks. First, to successfully join the cylinder to the plug to form the suture clip, the stirrup must be physically maintained in a retracted position while an opposing force is applied with a pusher to the plug. Second, the presence of the stirrup inevitably prevents the tube and therefore, the suture clip from being placed tight against the sutured tissue. This opens the possibility for slack to develop between the clip and the tissue, which can potentially lead to a relaxation of the desired tissue fold.
[0010] Suture anchors or clips and the means to deliver and secure them are quite common in the medical industry as they play a significant role in simplifying the tedious task of securing tissue previously accomplished by tying knots on sutures. Quite common are metallic twist tie, staples and various forms of plastic or metallic permanent or temporary mechanical means to prevent the suture from slipping through the tissue. As a result of their function, the clips are typically designed to be large to overcome the stresses expected of them. Disclosed are several single and multi-component suture clips as well as a variety of relatively simple compact suture clip delivery devices that can be inserted into a natural body orifice or through the working channel of an endoscope to cinch a suture clip into the desired position in close proximity to or against the plication.
[0011] It is to be appreciated that the suture clips and suture clip delivery devices disclosed herein have a potentially wide range of applications including, but not limited to, the attachment of devices, e.g., pH monitor to the gastrointestinal wall, the closure of perforations or ulcers and the creation of anastomoses. Another useful application involves the use of radiopaque clips as fluoroscopic markers.
[0012] It is an object of the invention to provide a variety of suture clip designs that effectively disburse the forces applied to sutured tissue to prevent tearing. It is a further object of the invention to provide a suture clip delivery device that eliminates the need to manually apply opposing forces to construct a suture clip. Another object of the invention is to provide a suture clip delivery device that enables the user to place the clip tight against the sutured tissue to eliminate or at least minimize any slack development in the suture. A further object is to provide a suture-severing device that severs suture ends proximal to the suture clip. A still further object is to reduce the number of steps needed to assemble and cinch a suture clip and sever the excess suture material. These and other objects of the invention will become apparent from a reading of the following sections.
[0013] One of the suture clip delivery and locking systems described herein includes a tool designed to be attached to the distal end of an endoscope or catheter among other possibilities. The tool has a body from which finger-like segments project distally. The finger-like projections are made of a material that allows the finger-like projections to flex or spring from a first closed position to a second open position and back to the first position. The finger-like projections define a chamber within which a suture clip is premounted or introduced by being advanced through the endoscope or catheter. The chamber is defined axially at a distal end by tangs extending radially inwardly from the distal ends of the finger-like projections and at a proximal end by proximal tangs or cam followers that extend radially inwardly from inner walls of the finger-like projections. A pusher, adapted to slide within the tool's body, is provided having a head that is adapted to mate with the cam follower to move the finger-like projections to the second open position when the pusher is advanced distally in and through the endoscope or catheter.
[0014] The suture clips described herein are designed to allow the suture to interwind through the clips in such a manner that the clips move with minimal friction while in an open position. In a closed position, the clip captures the suture, by the increased friction. The suture passes proximally through the chamber between the pusher head and mating tang and then outward through a lumen in the chamber and continues proximally outside the endoscope or catheter to the proximal end of the entire system. The user may thread a suture through a clip and then load the clip into the tooling. The clip may, in certain designs, already be premounted and then require the final advance by the physician to the site. At the site the physician activates the handle to apply a force to the clip, thereby locking it to the suture. The application of force first secures the clip and captures the suture material within the mating surfaces, and then expels the clip from the tool to remain within the patient.
[0015] Suture clips disclosed herein include friction fit embodiments where the components of the clips capture the suture with friction, alignable finger embodiments that involve unaligned rails with apertures formed in each rail that provide a tortuous path for suture engagement that captures the suture and cylinder embodiments including locking cap embodiments, locking inner rod embodiments, inner wedge embodiments, opposing eyelets embodiments and wrapped cylinder embodiments that capture the suture with a mating semicircular sleeve.
[0016] The present invention pertains to improvements to an endoscopic suturing device such as that disclosed in U.S. Pat. Nos. 5,792,153 and 5,080,663, the contents of which are incorporated by reference herein in their entirety. The improved suturing device and methods of the present application can be used to suture tissue internally via an endoscope for a wide variety of purposes such as: attaching a feeding tube to small intestine; closing intestinal openings in the case of a fistula, repairing esophageal tears and suturing tissue sites of localized bleeding. However, the invention is especially useful in the endoscopic suturing procedures to treat gastroesophageal reflex disease (GERD).
[0017] Another embodiment of the suture delivering, locking and severing systems described herein includes a multi-coaxial catheter with a three or four finger collet jaw affixed at a distal end. The catheter has a distal end from which the collect fingers distally project. The collet fingers are made of a material such as stainless steel or an engineering grade of plastic that allow the collet fingers to flex or spring from a pre-biased first open position to a second closed position and back to the first position. Alternatively, the collet fingers can be designed to flex or spring from a pre-biased first closed position to a second open position and back to the first position. The collet fingers define a cage within which a suture clip assembly is premounted. The cage is defined proximally by a distal end of the collet body and distally by flanges extending radially inwardly from the distal ends of the collet fingers. The case is sized so that a plurality of suture clip plugs can be preloaded into the cage along with a single suture clip ring. By biasing the collet fingers in an open position, the need for cam surfaces and cam followers is eliminated.
[0018] In one embodiment, a single pusher, adapted to slide within the catheter body, is provided to engage loaded suture clip components and to disengage an outer sliding sleeve that is used to radially constrain the collet fingers into a closed position. In another embodiment, a separate control surface provided coaxially about the collet cage is employed to slide the outer sliding sleeve relative to the collet cage and the pusher.
[0019] With any of the embodiments, the outer sliding sleeve is provided to secure the collet fingers in a closed position when placed in a distally advanced position. The outer sliding sleeve performs the additional function of severing the suture at a point proximal to the suture clip after engagement of the suture upon proximal retraction. One or more sutures slot are provided in the distal end of the outer sliding sleeve to provide suture exits. A distal end of the suture slots are sharpened to sever the suture. Upon proximal retraction of the outer sliding sleeve, the distal end of suture slot engages the suture and severs it when the distal end of the suture slot travels proximally to the proximal end of the collet fingers. Optionally, a fixed metallic ring can be affixed to the outer surface of the collet at a point proximal to the collet fingers and inside the outer sliding sleeve. The metallic ring is formed with a sharp distal tip that engages and severs the suture when the outer sliding sleeve is proximally retracted. The design enables the suture clip to be cinched in close proximity to the sutured tissue as well as allow for the severing of the suture tails and release of the suture from the delivery device in one step.
[0020] The suture clips designed for use with the referenced suture clip delivery systems are comprised of a plug and a ring that are configured to allow a suture to interwind through the clip in such a manner that the clip components move with minimal friction while in an open position. The plug is a headless design that has features that allow for a positive lock with the ring. Channels are provided in the plug to provide access ways for the suture to lessen the effort needed to thread the suture into the plug. The locking features of the plug are compressible so that when in a locked state, the suture is captured via a combination of frictional engagement and the locking surfaces The plugs have features built into their proximal and distal ends to allow stacking of the plugs to enhance alignment for the delivery of axial forces to set the plugs in rings. Additionally, a diverter for channeling the suture into axial slots formed in the plug is provided in one embodiment to extend distally of the distal end of the ring, when assembled with the plug, to interrogate the tissue and cause fibrosis. The fibrosis causes the tissue to become more bulky which is though to enhance the therapeutic effect of this technique.
[0021] In another embodiment, the plug and ring are formed with inter-locking ribs or scales that enhance the advancement of the plug into the ring and prevent disengagement. The ribs are fashioned to allow one-way movement of the suture through the suture clip.
[0022] Once threaded into the ring and plug, the suture is passed through finger slots formed between adjacent collet fingers and out the suture slot of the outer sliding sleeve. This enables the suture tails to be channeled externally of the catheter for removal at the proximal end of the catheter outside the patient after the tails have been severed at a point proximal to the now assembled suture clip. The catheter operator may thread a suture through a clip and then load the clip into the tooling or thread the suture through a premounted clip. At the site the physician activates the handle to apply a force to the clip, thereby locking it to the suture. The application of force would first secure the clip components capturing the suture material within the mating surfaces, and then expel the clip from the tool to remain within the patient.
[0023] Suture clips disclosed herein include combination friction fit and positive locking embodiments where the components of the clips capture the suture with friction and lock the suture in place with inter-locking surfaces. It is to be appreciated that a wide variety of suture clip configurations can be formed from the basic ring/plug configuration that employs a friction fit/positive lock securing means.
[0024] A yet further suture locking and severing system described herein includes, in one general embodiment, a multi-coaxial catheter, and in a second general embodiment, a system dimensioned for use in the working channel of an endoscope. Each general embodiment has a two, three or four finger collet jaw affixed at a distal end. The collet jaw has a collet body from which the collet fingers distally project. The collet fingers are made of a material such as stainless steel or high modulus plastics that allow the collet fingers to flex or spring from a first closed position to a second open position and back to the first position. Alternatively, the collet fingers can be designed to flex or spring from a first open position to a second closed position and back to the first position. This is accomplished by providing a radial bias in either the open or closed position. The collet fingers define a cage within which a suture clip assembly is premounted. The cage is defined proximally by a distal end of the collet body or by ramps formed on the inside walls of the collet fingers distal to the collet body and distally by flanges extending radially inwardly from the distal ends of the collet fingers. A further spatial restriction is provided toward the proximal end of the cage by the ramps that extend radially inwardly from the inner walls of the collet fingers and that additionally function as cams to open the collet fingers.
[0025] In one embodiment, a single pusher, adapted to slide within the catheter body, is provided to engage loaded suture clip components. In this embodiment, the collet fingers are biased in an open position. In another embodiment, a two-pusher system is employed that utilizes an inner pusher to secure a plug to a ring that together comprise the suture clip. A second pusher provided coaxially about, and in sliding engagement with, the inner pusher has a tapered distal end that interacts with the proximal ramps when advanced distally to cause the collet fingers to move from a closed position to an open position.
[0026] With any of the single or double pusher embodiments, an outer sliding sleeve can be provided to secure the collet fingers in a closed position when placed in a distally advanced position. The outer sliding sleeve performs the additional function of severing the suture at a point proximal to the suture clip after engagement of the suture. A suture slot is provided in the distal end of the outer sliding sleeve to provide a suture exit. Upon proximal retraction of the outer sliding sleeve, the distal end of the suture slot engages the suture and severs it when the distal end of the suture slot travels proximal to the proximal end of the collet fingers. Optionally, a fixed metallic ring can be affixed to the outer surface of the collet at a point proximal to the collet fingers and inside the outer sliding sleeve. The metallic ring is formed with a sharp distal tip that engages and severs the suture when the outer sliding sleeve is proximally retracted. The design enables the suture clip to be cinched in close proximity to the sutured tissue as well as allow for the severing of the suture tails and release of the suture from the delivery device in one step.
[0027] In yet a further embodiment, a head of the plug portion of the suture clip can be chamfered to engage the aforementioned ramps or ramps formed on the inner surfaces of the distal ends of the collet fingers to open the collet segments when a single pusher is distally advanced. This allows for the engagement of the plug and ring and release of the joined plug and ring in one step. The dimensions of the suture clip and collet segments are optimized to allow for full engagement of the plug and ring prior to clip release from the delivery device.
[0028] The suture clips designed for use with the suture clip delivery system are comprised of a plug and a ring that are configured to allow a suture to inter-wind through the clip in such a manner that the clips move with minimal friction while in an open position. In a closed position, the clip captures the suture by frictional engagement. Once threaded into the ring and plug, the suture is passed through finger slots formed between adjacent collet fingers and out the suture slot of the outer sliding sleeve. This enables the suture tails to be channeled externally of the catheter for removal at the proximal end of the catheter outside the patient after the tails have been severed at a point proximal to the now assembled suture clip. The catheter operator may thread a suture through a clip and then load the clip into the tooling or thread the suture through a premounted clip. After positioning the delivery system at the sutured tissue site, the device operator activates the handle to apply a force to the clip, thereby locking it to the suture. The application of force first secures the clip components thus capturing the suture material within the mating surfaces, and second expels the clip from the delivery system tool to remain within the patient.
[0029] Suture clips disclosed herein include friction fit embodiments where the components of the clips capture the suture with friction. It is to be appreciated that a wide variety of suture clip configurations can be formed from the basic ring/plug configuration that employs a friction fit securing means. Of course, the ring and plug components of the clip can be provided with interlocking features for enhancing the suture capturing effect.
[0030] In a still further embodiment, a suture clip delivery device having pivoting collet fingers is disclosed. The collet fingers rotate about a pin secured to a collet cage body. A pusher, suture clip component or other component radially restrains the pivoting collet fingers from pivoting radially outwardly at a distal end when proximal to a cinched position. Another embodiment employs a ring secured about the collet cage body. A distal edge of the ring provides a pivot point and eliminates the need to secure the pivoting collet fingers to the collet cage with pins.
[0031] Also disclosed is a suture clip loader used to deliver the suture clip components into the collet cage. The suture clip loader has two main components, a main body through which a hypotube is secured and a plunger comprising a plunger head and a plunder rod. The plunger rod is dimensioned to slide freely within the hypotube. A suture clip ring is placed over a first end of the hypotube that is situated within a cavity formed in the loader main body. The distal end of a suture clip plug is loosely fit within the lumen of the first end for delivery into a collet cage. A collet cage with the collet fingers in an open position is advanced over the plug, hypotube and ring. Advancement of the plunger into the hypotube from a second hypotube end causes disengagement of the suture clip plug into the collet cage. The collet cage fingers are then moved into a closed position by advancing the outer sliding sleeve so as to grasp the suture clip ring that is retained in the collect cage when the collet cage is removed from the hypotube
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[0222] Referring to FIGS.
[0223] Device
[0224] Fingers
[0225] Extending radially inwardly from fingers
[0226] A pusher
[0227] An alternative to the delivery device shown in
[0228] To operate device
[0229] Referring to
[0230] Referring to FIGS.
[0231] Disk post
[0232] In the embodiment shown in
[0233] To use this embodiment of suture clip assembly
[0234] Before securing suture disk
[0235] Once suture clip assembly
[0236] In an alternative embodiment shown in
[0237] A further embodiment is shown in
[0238] FIGS.
[0239] The offset nature of suture apertures
[0240]
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[0246] A snare
[0247] To operate delivery tube
[0248] To place suture clip
[0249] FIGS.
[0250] With this suture clip embodiment, cylinder
[0251]
[0252] FIGS.