Endoscopic tissue approximation system and methods

Abstract

To improve an endoscopic tissue approximation system and methods.SOLUTION: A deployment system includes: a sheath; a torque able shaft having a handle positioned at its proximal end; a detachable helical first suture anchor positioned at the shaft distal end; and an elongate suture fixedly coupled to the suture anchor. The deployment system can be positioned in a first tissue, and causes the shaft to rotate to advance the helical first suture anchor into engagement with the first tissue. The shaft is detached from the first suture anchor, thereby deploying it in the first tissue location. Then, the deployment system is removed from the patient, and a second suture anchor is coupled to the distal end of the shaft. The deployment system is re-inserted into the patient, the distal end of the system is moved adjacent a second tissue location, and the process is repeated for a second suture anchor at the second tissue location. The suture extends between the first and second fasteners, and tension is applied to the suture to draw the first and second tissues toward each other to reconfigure the tissue.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This application claims priority to U.S. Patent Application No. 16 / 701,276, filed December 3, 2019, U.S. Provisional Application No. 62 / 928,516, filed October 31, 2019, and U.S. Provisional Application No. 62 / 775,542, filed December 5, 2018, all of which are incorporated by reference herein in their entireties.

[0002] The present disclosure relates to surgical instruments and methods, and more particularly to instruments for placing fasteners and hemostatic clips, as well as suturing methods and devices used in endoscopic, laparoscopic, and other surgically or minimally invasive procedures. [Background technology]

[0003] The gastrointestinal tract is home to numerous conditions requiring intervention, including gastrointestinal ("GI") bleeding and perforation. GI bleeding is often associated with peptic ulcer disease and can be fatal if left untreated. When a patient experiences a suspected GI bleeding event, the endoscopist can perform a diagnostic endoscopy to identify the lesion and determine the best course of treatment. From an endoscopic perspective, the endoscopist has several options available to treat the patient. In cases of minor bleeding, the endoscopist can utilize thermal cauterization to cauterize the lesion and achieve hemostasis. Thermal cauterization treatments are typically used for well-identified, localized lesions and carry the risk of perforation by the cauterization probe. Rebleeding is a common outcome of this treatment.

[0004] Another method for achieving hemostasis involves the use of endoscopically placed hemostatic clips. When properly placed, hemostatic clips exert compressive force on the bleeding site, causing hemostasis. Although clips are easy to use, they are difficult to position precisely in relation to the lesion, and once "fired," they lack the ability to be removed and repositioned. For this reason, multiple clips are often used to control bleeding or close a perforation. Furthermore, each clip is small and has a surface area that affects only a localized area of ​​tissue.

[0005] Another method for endoscopically controlling gastrointestinal bleeding is to use a suturing instrument, such as the system disclosed in U.S. Patent No. 8,287,556 to Gilkey et al. This suturing instrument is coupled to a dual-channel endoscope and is capable of interrupted or continuous suturing. The bleeding site can be sutured and tightened to achieve hemostasis. Furthermore, if bleeding is accompanied by perforation, the suturing instrument can be used to suture and close the perforation. While capable of controlling gastrointestinal bleeding, this suturing system is quite complex and must be used with specialized dual-channel therapeutic endoscopes that are not widely available. Therefore, a less complex solution is needed for the treatment of gastrointestinal bleeding and perforations.

[0006] Other gastrointestinal procedures, such as the creation of anastomoses, closure of gastrointestinal perforations, and tissue remodeling procedures for ulcer treatment, require the ability to precisely and selectively target intended tissues for remodeling or approximation while excluding non-target tissues and organs. These requirements also hinder other endoscopic procedures involving the stomach and other organs. For example, many effective surgical procedures have been developed to inhibit gastroesophageal reflux disease. Illustratively, one such procedure creates a loop around the proximal stomach that acts as a barrier to the resolution of the lower esophageal sphincter. However, when performing these procedures endoscopically, limitations of endoscopic suturing procedures make them difficult.

[0007] One solution is proposed in U.S. Patent Application Publication No. 2007 / 0276408 to Filipi et al., which describes an instrument that can be removably or permanently attached to the end of an endoscope or made integral with the endoscope. The instrument includes a belt with multiple slots that carries a circumferentially arranged array of T-fasteners. The T-fasteners are connected to each other with a running suture. The belt can be rotated around the end of the endoscope, causing the multiple slots and T-fasteners to move into alignment with a pusher rod positioned within the working channel of the endoscope. Actuating the pusher rod advances the aligned T-fasteners from the belt into tissue, while the deployed T-fasteners remain connected to the suture. After each deployment of a T-fastener, the belt is rotated to displace an adjacent T-fastener into alignment with the pusher rod, and the pusher rod is again actuated to deploy the subsequent T-fastener. This process is repeated to deploy additional T-fasteners. After the T-fasteners are deployed into the tissue, tension can be applied to the sutures to draw the clamped tissue together, clamping against the tissue and maintaining tension, permanently reducing the space between the fasteners. Thus, one procedure can reduce stomach volume to treat obesity, while another can strengthen the lower esophageal sphincter to reduce gastroesophageal reflux.

[0008] However, the Filipi et al. system has several drawbacks that make its use impractical. First, in various embodiments, the system may require modification of a standard endoscope, either by permanent attachment thereto or by integral fabrication of the system at its distal end. However, surgeons are known to prefer using endoscopes they are familiar with and would not readily permanently modify a very expensive endoscope for limited use. Second, the system in all embodiments has a diameter larger than the distal end of a standard endoscope. This results in a bulky instrument that is difficult to manipulate and cumbersome when maneuvering in tight spaces or small body cavities. Third, the system requires that the onboard belt and all fasteners be driven by a rotational motion at the distal end of the endoscope, so that the belt and each subsequent T-fastener can be advanced and aligned with the pushrod for T-fastener deployment. Such mechanical motion is difficult to achieve at the distal end of an endoscope. Misalignment could result in a T-fastener not deploying or an incorrect T-fastener being used. Fourth, the T-fasteners are placed without knowing what tissue is behind the target tissue. Therefore, the deployed T-fasteners may puncture and injure unintended tissue behind the target tissue. Fifth, to be practical, this system would require all of the T-fasteners loaded into the belt slots to be deployed before the endoscope is pulled away from the excess sutures to secure them with the cinch. Therefore, this system is not particularly suitable for flexible surgical procedures. For these and other reasons, there is a need for novel devices and methods. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent No. 8,287,556 [Patent Document 2] US Patent Application Publication No. 2007 / 0276408 Summary of the Invention

[0010] Provided herein are suture anchors, placement of multiple suture anchors, deployment systems, and methods for deploying one or more suture anchors along with sutures into tissue. A suture anchor is a type of fastener having a helical portion adapted to engage and be retained in tissue. The suture anchor has a distal helical portion and a proximal receiving portion. The suture anchor has a longitudinal axis extending through the receiving portion and the helical portion. A suture eyelet is fixedly coupled to the suture anchor between the proximal and distal portions and is rotatable about the longitudinal axis of the suture anchor. The suture anchor receiving portion includes a tubular member having a retention member adapted to engage with a post member of a deployment system, such that when the post member of the deployment system is inserted into the receiving portion, the retention member engages with the post member, retaining the suture anchor on the deployment system. The helical portion of the suture anchor is typically formed from a coiled wire having a sharp tip that, when rotated, pierces and engages tissue. The coiled wire is preferably formed of a biocompatible, implantable material. Many suitable materials exist, including metals such as stainless steel and cobalt chromium (CoCr), and biodegradable materials such as nylon, polyetheretherketone (PEEK), polyethylene terephthalate (PET), acrylonitrile butadiene styrene (ABS), polycarbonate, PDO, PGA, PCL, composites, and bioglass. An elongated suture having a proximal end and a distal end is fixedly coupled to the suture eyelet, such that rotation of the suture anchor by an attached deployment system rotates the receiving portion and helical portion without rotating the eyelet portion to prevent wrapping and tangling of the elongated suture on the deployment system.

[0011] Multiple similar suture anchors may be used to perform a tissue reconstruction procedure. The distal end of a suture is fixedly secured to a first suture anchor, while additional suture anchors are attached to the suture through the suture anchoring eyelet. The distal end of the suture is provided with an end structure that limits its movement relative to the suture retainer of the first, most distal suture anchor. The end structure may have an enlarged knob or attached bead that acts as a stop for the suture retainer. Alternatively, the end structure may be directly attached to the suture retainer by tying it to the suture retainer.

[0012] A suture anchor is provided having a proximal portion and a distal portion in the form of a coil. The distal-most portion of the coil has a sharp tip capable of piercing tissue. The coil has a longitudinal length preferably selected for the tissue in which it is to be placed. For example, the thickness of stomach tissue can range from 5 mm to 8 mm, including the mucosal and muscular layers. A corresponding suture anchor coil portion can have a longitudinal length of approximately 8 mm, so that when tissue is engaged by the coil portion, the coil portion can be securely anchored to the muscular layer without extending through the stomach wall and engaging tissue beyond the stomach wall. In another example, the suture anchor has a length suitable for use in the colon. Typically, colon tissue can have a thickness of approximately 0.2 mm to 5 mm, including the mucosal and muscular layers. A corresponding suture anchor coil suitable for colon tissue can have a longitudinal length of approximately 2 mm to 3 mm.

[0013] A suture anchor is provided having a proximal portion and a distal portion in the form of a coil containing a beneficial coating. The coating can be in the form of a swellable material. For example, as a suture anchor coil (without a beneficial coating) is anchored in tissue, the distal portion of the coil pierces the tissue with the more proximal portion of the coil following. This process can enlarge the passageway in the tissue taken by the coil, loosely anchoring the suture anchor to the tissue. With a suture anchor coil having a swellable coating, a loosely anchored suture anchor becomes more firmly anchored as the coating expands and fills the enlarged passageway created by the coil. Furthermore, if the coil portion of the suture anchor extends beyond the tissue wall, the swellable coating will reduce or eliminate the risk of fluid passing through the passageway created by the suture anchor. Alternatively, the beneficial coating can include therapeutic compounds or agents, such as antibacterial, antifungal, antiviral, and antibiotic agents, to prevent or minimize infection. Another form of beneficial coating may include therapeutic compounds or substances that may accelerate the healing response of the associated tissue and defect.

[0014] A suture anchor deployment system is provided for deploying multiple suture anchors in series during a surgical procedure. The deployment system is preferably suitable for endoscopic or laparoscopic use, although it can also be used in open surgery.

[0015] The deployment system includes a proximal handle, a delivery member having a proximal end and a distal end rotatably coupled to the handle, and a suture anchor engagement post at the distal end of the delivery member. The delivery member preferably takes the form of an elongated, torqueable shaft. The elongated shaft can be formed from a flexible cable, wire, tubular catheter, or advanced structure, as described in commonly owned U.S. Pat. No. 10,238,411 to Mitelberg et al. The suture anchor is removably coupled to the delivery member post for delivery to the target site. The deployment system can also include a sheath extending over the delivery member and the attached suture anchor to prevent the sharp edges of the suture anchor from damaging the flexible endoscope channel when delivering the suture anchor to the internal target site. The sheath can be retractably coupled to the deployment system and can be a separate liner inserted through the endoscope's instrument channel to act as a protective barrier between the sharp edges of the suture anchor and the walls of the instrument channel. Once the suture anchor is positioned adjacent to the target tissue site, the handle is manipulated to rotate the elongate shaft, thereby rotating the helical portion of the suture anchor, thereby engaging tissue at the target site. After engaging the tissue, a different target site can be selected by manipulating the handle to rotate the shaft in the opposite direction, thereby rotating the suture anchor in the opposite direction and disengaging it from the previously engaged tissue. At this point, the suture anchor can be repositioned at the new target site and rotationally engaged with tissue. Once the suture anchor is properly positioned, the suture anchor and delivery member post can be moved relative to one another to separate the delivery member post from the suture anchor. A second sheath extending over the elongate shaft, but not over the suture anchor, can be advanced over the elongate shaft, with the distal end of the second sheath exerting a force against the proximal end of the suture anchor to separate the suture anchor from the delivery member post. Once the first suture anchor has been deployed at the target site, a second suture anchor engaging the post member of the delivery member can be reloaded into the deployment system. As previously described, a second suture anchor is attached to the elongate suture through the suture eyelet.A second suture anchor can then be positioned at the target site and rotated to engage the tissue (without the suture wrapping around the delivery member). After deployment of the second suture anchor, additional suture anchors can be loaded onto the delivery member and deployed as needed. Once the final suture anchor has been deployed, a clamping device (as disclosed in U.S. Pat. No. 8,540,735 to Mitelberg et al., incorporated herein by reference) is attached to the suture and used to apply the appropriate tension to the suture (drawing the suture anchor and associated tissue together) to reconfigure the tissue, and can then be used to maintain the tension and cut off any excess suture.

[0016] Additional suture anchors may be removably attached to a card or other member that attaches to the endoscope. In the attached configuration, the suture anchors are pre-attached with sutures. The suture anchors are each provided on a removable plug that can be individually released from the card and manipulated to load the suture anchor onto the delivery member post.

[0017] In one embodiment, the delivery member and attached suture anchor are sized to extend within the working channel of an endoscope, and in the same embodiment, the delivery member and any sheath are all sufficiently flexible for use within the working channel of an endoscope that extends through a tortuous path, particularly a curved endoscope.

[0018] In use, the deployment system loaded with a first suture anchor is advanced through or pre-positioned within the working channel of an endoscope or lumen. In one method, the endoscope is positioned within a natural body cavity, such as the stomach or esophagus, with the distal end of the endoscope positioned within the stomach. The distal end of the deployment system is advanced through the working channel, and a sheath protecting the distal end of the suture anchor is retracted, positioning the distal-most end of the suture anchor relative to a first target tissue location where the first suture anchor is to be deployed. Once the helical portion of the suture anchor contacts the first target tissue location, the first suture anchor is rotated so that the helical portion of the suture anchor pierces and engages the tissue. If the suture anchor is satisfactorily positioned, the suture anchor is removed from the deployment system and retained in its tissue-engaging position.

[0019] The deployment system is then removed from the working channel of the endoscope, and a second suture anchor is loaded into the distal end of the deployment system. The deployment system is then reinserted into the endoscope working channel, and the distal end of the deployment system is moved to a second target tissue location, and the process is repeated to engage the tissue and deploy the next suture anchor. This process is repeated as necessary to place multiple suture anchors at various locations appropriate for the therapeutic procedure.

[0020] Suture anchors can be deployed in a variety of patterns to provide various tissue approximations. For example, they can be positioned in a zigzag pattern, a rectangular pattern, a circular pattern, or partially inside and partially outside the defect, and then cinch-tightened to close the defect. Additionally, suture anchors can be deployed to secure implants such as feeding tubes, stents, gastric balloons, etc., or can be used as markers without suturing.

[0021] Once the suture anchors are deployed within the tissue, the deployment system can be withdrawn from the working channel over the suture. A clamping device is advanced over the suture, preferably through the same working channel. Tension is applied to the suture, pulling it through the suture anchors, thereby approximating the first, second, etc. target tissue location. Once the appropriate tension is applied to achieve tissue remodeling, a cinch is fastened to the suture to hold it in place. Alternatively, a cinch may not be required and the suture may be tied to maintain its tension.

[0022] The suture anchor deployment system offers several advantages: it can be deployed through the working channel of a conventional endoscope, requiring no modifications to the endoscope; and the deployment system does not increase the overall diameter of the distal end of the endoscope. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 is a cutaway side view of a suture anchor deployment system. [Figure 2] FIG. 2 is a partially enlarged cross-sectional side view of a distal portion of a suture anchor deployment system. [Figure 3] FIG. 3 is an enlarged side view of a suture anchor extending from a distal sheath of a suture anchor deployment system. [Figure 4A] FIG. 4A is an enlarged side view of the distal end of the delivery member and suture anchor. [Figure 4B] FIG. 4B is an enlarged perspective view of the distal end of the delivery member and the suture anchor. [Figure 4C] FIG. 4C is a partial cross-sectional perspective view of an enlarged view of the delivery member and suture anchor. [Figure 5A] FIG. 5A is an enlarged, partial cross-sectional side view of the distal end of a delivery member and an alternative embodiment suture anchor. [Figure 5B] FIG. 5B is an enlarged partial cross-sectional view of the distal end of the delivery member and suture anchor of another alternative embodiment. [Figure 6A] FIG. 6A is an enlarged view of yet another embodiment of a suture anchor. [Figure 6B] FIG. 6B is a partial cross-sectional side view of the suture anchor of the embodiment shown in FIG. 6A. [Figure 7A] FIG. 7A illustrates use of a suture anchor deployment system with the distal end of the deployment system extending through an endoscope adjacent tissue having a tissue defect. [Figure 7B] FIG. 7B shows use of the suture anchor deployment system with the deployment system retracted to expose the connected suture anchor. [Figure 7C] FIG. 7C illustrates use of the suture anchor deployment system and rotation of the deployment system such that the suture anchor engages tissue in a first position. [Figure 7D] FIG. 7D illustrates use of the suture anchor deployment system, with the release of a first suture anchor and the distal end of the deployment system having a second suture anchor extending from an endoscope. [Figure 7E] FIG. 7E illustrates use of the suture anchor deployment system with the deployment system having a second suture anchor positioned adjacent to a second tissue location. [Figure 7F] FIG. 7F illustrates use of the suture anchor deployment system with a second suture anchor engaged with tissue in a second position removed from the deployment system. [Figure 7G] FIG. 7G illustrates the use of a suture anchor deployment system where the suture anchor tensions the suture to close the tissue defect. [Figure 7H] FIG. 7H shows the use of a suture anchor deployment system to close a tissue defect using an approximated suture anchor maintained under tension applied using a cinch. [Figure 8] FIG. 8 is a top perspective view of a suture anchor deployment kit. [Figure 9A] FIG. 9A is a side elevational view of a suture anchor deployment system according to another embodiment. [Figure 9B] FIG. 9B is a longitudinal cross-sectional view of the suture anchor deployment system taken along line 9B-9B of FIG. 9A. [Figure 10] FIG. 10 is a partially transparent side elevational view of the delivery device distal end of the suture anchor deployment system of FIG. 9A, shown without the suture anchor and sutures. [Figure 11] FIG. 11 is a partially transparent side elevational view of the distal end of the delivery device of the suture anchor deployment system of FIG. 9A, showing the suture anchor and suture. [Figure 12] FIG. 12 is a longitudinal cross-sectional view taken along line 12-12 of FIG. [Figure 13] FIG. 13 is a side elevational view of one embodiment of a suture anchor. [Figure 14] FIG. 14 is an end view of the suture anchor embodiment of FIG. [Figure 15] FIG. 15 is a side elevational view of a laser cut tubular element of one embodiment of a suture anchor. [Figure 16] FIG. 16 is a side elevational view of an eyelet ring for a suture anchor according to one embodiment. [Figure 17] FIG. 17 is an end view of the eyelet ring of FIG. [Figure 18] FIG. 18 is a side elevational view of a laser cut tubular element for a suture anchor according to another embodiment. [Figure 19] FIG. 19 is a diagram of an endoscope with a mounting for a suture anchor deployment system. [Figure 20] FIG. 20 is a diagram of a card storing plugs that hold additional suture anchors. [Figure 21] 21 is a view of the card of FIG. 20 shown attached to the mount of FIG. [Figure 22] FIG. 22 illustrates a method for correcting a defect in the digestive tract using a suture fixation system. [Figure 23] FIG. 23 illustrates a method for correcting a defect in the digestive tract using a suture fixation system. [Figure 24] FIG. 24 illustrates a method for correcting a defect in the digestive tract using a suture fixation system. [Figure 25]FIG. 25 illustrates another method of using a suture anchor deployment system to correct defects in the digestive tract. [Figure 26] FIG. 26 illustrates another method of using a suture anchor deployment system to correct defects in the digestive tract. [Figure 27] FIG. 27 illustrates another method of using a suture anchor deployment system to correct defects in the digestive tract. [Figure 28] FIG. 28 illustrates another method of using a suture anchor deployment system to correct a defect in the digestive tract. [Figure 29] FIG. 29 illustrates another method of using a suture anchor deployment system to correct a defect in the digestive tract. [Figure 30] FIG. 30 illustrates a method for implanting a feeding tube in the digestive tract using a suture anchor deployment system. [Figure 31] FIG. 31 illustrates a method for implanting a stent in the digestive tract using a suture anchor deployment system. [Figure 32] FIG. 32 illustrates a method of implanting a gastric balloon within the digestive tract using a suture anchor deployment system. [Figure 33] FIG. 33 illustrates a method for marking tissue regions in the digestive tract using a suture anchor deployment system. [Figure 34] FIG. 34 illustrates a method for marking tissue regions in the digestive tract using a suture anchor deployment system. DETAILED DESCRIPTION OF THE INVENTION

[0024] With reference to the following description, the terms "proximal" and "distal" are defined relative to the hand of a user of the device, with "proximal" being closer to the user's hand and "distal" being further away from the user's hand, as the device is often located further within a patient's body during use. Furthermore, in accordance with a general description of the system and its exemplary uses, detailed below, a system is provided and used to target tissue, deploy suture anchors into the tissue, and reconstruct the secured tissue. The targeting, fixation, and reconstruction described above are preferably, but not necessarily, performed in conjunction with a surgical scope, such as a laparoscope or endoscope. In the embodiments described herein, steps for reconstructing tissue through or with an endoscope may be used, in which the instruments acting to reconstruct the tissue are inserted through a lumen, i.e., the gastroesophageal pathway, preferably without an incision into either the patient's skin or internal tissue, to allow for the necessary instrument passage. It is specifically recognized that puncturing tissue to insert fasteners does not result in an incision in the tissue.

[0025] 1-3, one embodiment of a tissue approximation system 2 is shown. The tissue approximation system 2 is intended to be delivered sterile for use during a single medical procedure and then discarded at the end of the procedure. The tissue approximation system 2 is particularly suited for catheter-based endoscopic access of soft tissue in the gastrointestinal tract. The tissue approximation system 2 includes a plurality of tissue anchors 42, an anchor delivery system 10 for implanting the anchors 42 at respective tissue locations within the gastrointestinal tract, and a suture element 46 for joining the plurality of tissue anchors 42. The tissue approximation system 2 preferably also includes a suture cinch system for applying tension to the suture 46, thereby drawing the plurality of implanted tissue anchors 42 toward one another and further holding the suture 46 in a cinched configuration, as described in U.S. Pat. Nos. 8,540,735 and 9,788,831, or U.S. Patent Application Publication No. 2017 / 0086818, the entire contents of which are incorporated herein by reference. These elements are described in more detail below.

[0026] In one embodiment, delivery system 10 includes an elongate sheath member 20 having a distal region 12, a proximal region 14, a distal end 22, a proximal end 24, and a lumen 26 extending therethrough. A delivery member 30, having a distal end 32 and a proximal end 34, is slidably disposed within lumen 26 of sheath member 20. Delivery member 30 takes the form of an elongate, flexible, torque-transmitting shaft having a handle member 40 coupled to proximal end 34. Delivery member 30 is preferably formed in the form of a cable, although other torque-transmitting configurations such as those found in catheters and guidewires may also be suitable. A suture anchor 42 is removably coupled to distal end 32 of delivery member 30. Suture anchor 42 has a distal end 44 and a proximal end 45 and is coupled to an elongate suture 46. The suture 46 has a distal end 47 connected to the suture anchor 42 and a proximal end 48 adjacent the proximal region 14 of the system 10 .

[0027] 2 and 3 show enlarged views of the distal region 12 of the deployment system 10. The distal end 32 of the delivery member 30 has an engagement post 50 with a rotation key 52. ​​The delivery member rotation key 52 is adapted to engage an anchor rotation key 54 of the suture anchor 42 when the suture anchor is attached to the delivery member.

[0028] In one embodiment of the suture anchor 42, the anchor 42 has a distally disposed coil 60 having a distal end 62, a proximal end 64, and a distal end 66. The coil 60 is preferably formed from stainless steel wire, although other metals such as cobalt chromium (CoCr), nitinol, titanium, nylon, PEEK, PET, ABS, polycarbonate, and biodegradable materials such as PDO, PGA, PCL, blends, bioglass, etc. may also be suitable.

[0029] The wire used to form the coil is preferably round, although other non-circular cross-sections, such as "D" shaped, oval (elliptical), rectangular, triangular, and polygonal shapes, may be suitable for forming the coil. The wire diameter may range from 0.025 mm (0.001 in.) to approximately 1.27 mm (0.050 in.) and is highly dependent on the characteristics of the particular tissue with which the coil will engage. The coil diameter generally depends on the diameter of the wire and the diameter of the mandrel used for winding. The coil diameter generally ranges from 0.76 mm (0.030 in.) to approximately 3.8 mm (0.150 in.) and is also dependent on the type of tissue and the dimensions of the endoscope channel. The suture anchor 42, located proximal to the coil 60, also includes a collar 68 fixedly coupled to a suture eyelet 70. The collar 68 and suture eyelet 70 are configured to be rotatable about the longitudinal axis of the suture anchor. The suture eyelet 70 is connected to the distal end 47 of the suture 46 and is preferably held in place through a knuckle 72 or other equivalent means such as adhesive or heat forming.

[0030] 4A-4C show various close-up views of the distal end of the delivery member 30 and the detached suture anchor 42. As shown in FIG. 4A, the engagement post 50 of the delivery member 30 has an engagement post head 80 with a tapered distal end 82 and an engagement post neck 84. The engagement post head 80 is bulbous and has a diameter larger than the diameter of the neck 84. FIG. 4C shows the alignment of the engagement post 50 and suture anchor 42 prior to engagement. The suture anchor 42 has an engagement receiver 90 extending proximally from the coil 60, with the distal portion 92 secured to the coil proximal end 64, preferably by laser welding or other suitable joining technique. The proximal portion 94 of the engagement receiver 90 is shown adjacent to the anchor rotation key 54. The engagement receiver 90 is a tubular member having a retention tab 96 cut from its wall. The retention tab 96 is generally angled toward the central axis of the engagement receiver. The retention tab 96 functions as a living hinge so that when the engaging post head 80 is inserted into the receiver 90, the tab 96 deflects upward, allowing the head 80 to pass over it. The retention tab 96 then moves to a perpendicular position in which it rests on the engaging post neck 84. This alignment between the retention tab and the post head and post neck, when engaged, releasably couples the suture anchor and delivery member. The anchor rotation key 54 is fixedly coupled to the engaging receiver 90, preferably by welding or other suitable joining technique.

[0031] An alternative embodiment suture anchor configuration is shown in Figures 5A and 5B. Figure 5A shows a partial cross-sectional side view of a suture anchor 100 that shares many similarities with anchor 42. Anchor 100 has a proximally positioned engagement receiver 102 and a distally positioned coil 104. An anchor rotation key 106 is fixedly coupled to engagement receiver 102. A collar 108 and suture eyelet 110 are distal to rotation key 106 and proximal to coil proximal end 112 and are positioned on and rotatable on engagement receiver 102. Coil 104 has a distal end 114 with a sharpened distal tip 116. Coil 104 is fixedly coupled to engagement receiver 102 via a spacer member 118. Spacer member 118 is preferably welded to receiver 102 and coil proximal end 112. The coil proximal end 112 has a closer winding pitch than the distal end 114, facilitating attachment to the receiver 102. The distal end 114 has a more open pitch so that the coil can easily engage tissue when rotated. The spacer member 118 is formed from a biocompatible material, and modifications to the suture anchor allow for the use of coils having diameters significantly larger than the diameter of the engaging receiver. The ability to vary the diameter of the coil and coil pitch allows for the creation of suture anchors suitable for different tissue stiffnesses and thicknesses.

[0032] FIG. 5B shows a suture anchor 120 of similar structure to suture anchor 100. Anchor 120 has a proximally positioned engagement receiver 122 and a distally positioned coil 124. An anchor rotation key 126 is fixedly coupled to engagement receiver 122. A collar 128 and suture eyelet 130 are positioned on and rotatable about engagement receiver 122, distal to rotation key 126 and proximal to coil proximal end 132. Coil 124 has a distal end 134 with a sharp distal tip 136. Coil 124 is fixedly coupled to engagement receiver 122 via a spacer member 138. Spacer member 138 is preferably welded to receiver 122 and coil proximal end 132. As shown in FIG. 5B, coil 124 tapers toward distal tip 136. This taper may aid in deploying the suture anchor 120 in tissue that is dense or has a tough consistency.

[0033] Referring to Figures 6A and 6B, another embodiment of a suture anchor having a configuration similar to previous suture anchors is shown. Figure 6A shows a perspective view of a suture anchor 200 having a coil 202. The coil 202 has a distal region 204 and a proximal region 206. The distal region 204 has a distal tip 208 suitable for piercing tissue. The proximal region 206 has a cross member 210 that generally traverses the diameter of the coil 202, creating a "D"-shaped opening. The cross member 210 has an opening 212 positioned at or near the center of the diameter of the coil 202. An eyelet shank 214, having a distally located suture eyelet 216 and a proximally located retention bead 218, is positioned through the opening 212. As shown in Figures 6A and 6B, the suture eyelet 216 is positioned within the coil 202 and is rotatable relative to the coil 202. The suture eyelet 216 can also be repositioned along the longitudinal length of the coil 202 by the sliding configuration of the eyelet shank 214 relative to the cross member 210. The ability of the eyelet shank to slide and the ability of the suture eyelet to rotate are important features for successful deployment of the suture anchor 200. Deployment of the suture anchor 200 requires a deployment system similar to deployment system 10, with some modifications. The engagement post of the delivery member would be modified to have a "D" shape to engage with the "D" shape formed by the cross member (not shown). This configuration allows the suture anchor to be placed on the engagement post, but additional retention features can be added to further secure engagement between the delivery member and the suture anchor. Other embodiments of suture anchors are described below.

[0034] When used at a target tissue location, the suture anchor disposed on the delivery member has an elongate suture fastened to the suture eyelet. In one embodiment, the suture is a 3-0 polypropylene suture, but may be any other suitable suture material, including polymer monofilament, polymer multifilament, polymer braid, metal wire, metal multistrand construction, metal braid, combinations of polymer and metal, natural biomaterials, and any other suitable suture material.

[0035] Rotating the handle of the delivery member rotates the engagement post, rotating the coil of the suture anchor. As the coil rotates, the distal tip of the coil engages the tissue and advances deeper into the tissue. The suture secured to the suture eyelet follows the helical gaps between the coil turns as the coil rotates within the tissue. When the suture eyelet contacts tissue, the suture eyelet remains generally stationary as the rotating proximal coil end approaches the suture eyelet. The rotational ability of the suture eyelet prevents the suture adjacent to the deployment system from wrapping around or otherwise becoming entangled with the delivery member. The sliding ability of the eyelet shank allows the suture eyelet to move from the distal end of the coil to the proximal end of the coil, meaning the coil is fully secured within the tissue.

[0036] According to one method of using deployment system 10 (other methods are described below), an endoscope is advanced through a natural body orifice, such as the stomach or esophagus, with the distal end of the endoscope positioned within a body cavity, such as the stomach. The distal portion of deployment system 10 is advanced through or pre-positioned within the working channel of the endoscope. Alternatively, the deployment system can be advanced through a peripheral canal external to the endoscope.

[0037] 7A, 7B, and 7C, the distal end of the deployment system extends from the working channel of the endoscope 140, and the sheath is retracted, revealing the first suture anchor 42 fixedly coupled to the suture 46 positioned near the target tissue adjacent to a gastrointestinal defect 142. The gastrointestinal defect 142 may incorporate a mucosal layer 144 or may protrude deeper to include a muscle layer 146. The distal-most end of the first suture anchor 42 is positioned relative to a first target tissue location 148 where the first suture anchor is to be deployed. Once the suture anchor coil portion contacts the first target tissue location, the first suture anchor is rotated by rotating the proximal handle of the delivery member, causing the coil portion of the suture anchor to pierce and engage the tissue. Once the first suture anchor 42 is properly positioned, the first suture anchor 42 is then detached from the delivery member 30, leaving it fixed within the tissue. If placement of the first suture anchor is not satisfactory, the delivery member can be rotated in the opposite direction to rotate the coil of the suture anchor in the opposite direction and disengage it from the tissue, allowing the suture anchor to be repositioned and deployed at another location.

[0038] After deploying the first suture anchor, the deployment system 10 is removed from the working channel of the endoscope 140, and a second suture anchor 42 (slidably coupled to the suture 46) is coupled to the distal end of the deployment system. The deployment system is then reinserted into the endoscope working channel, and the distal end of the deployment system is moved to a second target tissue location 150, and the process is repeated, engaging the tissue and deploying the second suture anchor 42, as shown in Figures 7D, 7E, and 7F. This process can be repeated as necessary to deploy additional suture anchors (slidably coupled to the suture 46) at various locations appropriate for the therapeutic procedure.

[0039] As shown in Figures 7G and 7H, once the suture anchors are deployed within the tissue, the deployment system can be withdrawn from the working channel. A clamping device (not shown) is then advanced over the suture to the last deployed suture fixation site. Tension is then applied to the suture 46, pulling the suture through the suture anchors, thereby approximating the first target tissue location, the second target tissue location, etc. Once the appropriate tension is applied to achieve the desired tissue reconstruction (closure of defect 142), the cinch 152 is fastened to the suture, holding the tissue reconstruction in place.

[0040] Referring to FIG. 8 , another embodiment of a tissue access system 302 is shown. The tissue access system 302 includes an anchor delivery device 310 for delivering multiple anchors 342 (one pre-mounted at the distal end of the delivery device and the others mounted in multiple holders 500 on a card 502) and a suturing element 346 for joining the multiple tissue anchors. The system may also include an endoscope attachment 504 for attaching the delivery device to an endoscope (not shown) during a medical procedure. The tissue access system also preferably includes an endoscope channel liner 480, which serves as a flexible, tubular protective barrier between the working channel of the endoscope and the anchor delivery system, and in particular, serves as a sharp anchor at the distal end of the delivery system. The delivery device, sutures, suture anchors, attachment, and channel liner are preferably provided in kit form 304 in a single-use package suitable for single use. The packaged kit is preferably provided pre-sterilized and ready for use.

[0041] 9A and 9B, delivery system 310 includes a proximal actuation handle 510 having a stationary shaft 512 and a longitudinally displaceable spool portion 514. Shaft 512 includes a thumb ring 516 and an axial slot 518. A worm gear 520 is rotatably mounted within axial slot 518. Spool portion 514 defines a finger grip 515 and a drive bar 521 that extends within slot 518. Drive bar 521 defines an inner bore 522 having a helical shape. Spool portion 514 is coupled in a closely spaced relationship across worm gear 520. Displacing spool portion 514 across worm gear 520 causes worm gear 520 to rotate about its longitudinal axis A. Torque-transmitting shaft 522 is fixed to the distal end of worm gear 520. As the worm gear rotates, the torque-transmitting shaft 522 rotates an equal degree of rotation.

[0042] 9A-10 , a longitudinally stiff sheath 524, such as a flat-wound coil, is disposed over a torquable shaft 522. A proximal end 525 of the sheath 524 is coupled to a ferrule 526, and a distal end 528 of the sheath has a substantially flat end 530. The ferrule 526 is threaded onto the distal end of the shaft 512 of the actuation handle 510 at threads 529. Rotation of the ferrule 526 causes longitudinal displacement as the ferrule 526 is advanced or retracted through the threads, resulting in longitudinal displacement of the flat end 530 of the sheath 524 relative to a suture anchor engagement post 350 fixed to the distal end of the torquable shaft 522. As described below, this allows for controlled disengagement of the suture anchor 542 from the engagement post 350.

[0043] As an alternative to deployment via threaded displacement of the ferrule, and thus the sheath, a spring release can be provided that, upon actuation, causes automatic longitudinal displacement of the sheath a predetermined distance sufficient to deploy the suture anchor from engagement post 350. The spring release is preferably actuated by a push button located on the proximal handle.

[0044] Referring to FIG. 10, engagement post 350 has a generally cylindrical proximal first portion 534, a reduced diameter second portion 536 that receives the proximal portion of the suture anchor, a shoulder 538 between the first and second portions that functions as a stop for the suture anchor, a third portion 540 that defines a plurality of opposing recesses 542 that function as keyways for receiving a rotation key in the suture anchor for applying a rotational force, and a bulbous distal fourth portion 544 that prevents undesired deployment until the suture anchor is disengaged.

[0045] 11-17, in one embodiment, the suture anchor 342 includes a laser-cut tube 550 and an eyelet ring 552. The laser-cut tube 550 defines a distal open helical coil 554 having a sharpened distal end 556, and a proximal post receiver 558. In one embodiment, the distal open helical coil 554 has a length of approximately 2.5 mm. As shown in FIGS. 11 and 12, the proximal post receiver 558 is sized to be received over the second, third, and fourth portions 534, 536, and 538 of the post 350, but is sized to rest against the shoulder 538 formed between the first and second portions. The receiver 558 includes a pair of recesses 560 adapted to receive the bulbous distal fourth portion 544 of the post, and a pair of radially inwardly extending first tabs 562 that form anti-rotation keys that extend into opposing recesses 542 on the post. The receiver also has two pairs of radially outwardly biased second tabs 564, each pair diametrically opposed from one another, that form a circumferential channel 566. The eyelet ring 552 has a circular first opening 568 and a second opening 570 located outside the periphery of the first opening. The circular first opening 568 is substantially the same diameter as the outer diameter of the tube 550. During assembly of the suture anchor 542, the proximal end 572 of the tube is pushed through the first opening 568 until the proximal ends of the outwardly biased second tabs 564 are displaced inward, allowing the ring 552 to seat within the channel 566. The proximal tabs are then released and moved back outward, securing the ring 552 in its longitudinal position on the tube (i.e., between the two pairs of tabs 564). While secured on the tube 550, the ring 552 can rotate around the tube 550. The second opening 570 receives the suture 546 therethrough. In this manner, the tube 550 can be rotated by rotating the deployment post 350, but the eyelet ring 552 and suture 346 are independent of and do not follow such rotation.

[0046] As shown in FIG. 15 , the laser-cut tube 550 can be formed with a variety of features. According to one embodiment, the windings of the coil 554 have a flat cross-section that corresponds to the wall of the tube 550; however, other cross-sectional shapes, including round and D-shaped, can be formed during the manufacturing process. Additionally, the coil can be formed with a constant or variable pitch. Additionally, one or both surfaces of the coil can be laser-textured or textured by other means to facilitate insertion and / or tissue retention. As an example, the laser-cut coil 554 a can be formed with a plurality of integral barbs 576, as shown in FIG. 18 .

[0047] In one embodiment, the suture anchor is comprised of only two elements: a tube and an eyelet ring. In a further embodiment, assembly requires only pressing the eyelet ring onto the tube; that is, no welding, brazing, adhesive, or other joint is required between the two components to hold them together. In another embodiment, the eyelet ring is rotatable on the tube but is retained longitudinally on the tube. In yet another embodiment, all of the features that retain the eyelet ring to the tube, as well as the assembled suture anchor to the deployment post, are formed by laser cutting appropriate structures into the tube.

[0048] It is recognized that the various configurations of the engagement post and laser cut tube can be reversed, i.e., the engagement post can be formed from a tube and cut with various tabs, and the suture anchor can be solid and form a recess that can be engaged by the post.

[0049] 9A, 9B, and 11, movement of spool portion 514 along worm gear 520 from one end to the other is suitable to cause sufficient rotation of helical coil 554 to fully embed the coil in tissue. That is, if coil 554 extends through 1140° of rotation, movement of spool portion 514 along worm gear through the length of slot 518 will cause flexible shaft 522 to rotate 1140°. If the procedure requires anchor 542 having coil 554 with a smaller angular rotation for full implantation, then spacer 580 (FIG. 9A) can be inserted at or over one end of the spool portion, which can function as a stop and travel limiter for the spool portion relative to the worm gear to limit the effective rotation caused by movement of the spool portion.

[0050] As described above, tissue access system 302 includes endoscope channel liner 480. Channel liner 480 is a flexible tube suitable for insertion into a 2.8 mm or larger working channel of an endoscope, such as a gastroscope or colonoscope, to protect the inner surface of the working channel from damage caused by the sharp distal end of the suture anchor. The proximal end of the channel liner may have an enlarged opening 482 to help guide the distal end of a delivery device therethrough. Channel liner 480 is preferably made from a combination of high-density polyethylene (HDPE) and low-density polyethylene (LDPE), more preferably from a combination of 80% HDPE and 20% LDPE. Alternatively, the deployment system may incorporate a retractable sheath that covers the sharp end of the helical coil until deployment of the anchor, as described above.

[0051] 8 and 19-21, all embodiments may provide a removable mounting portion 504 that temporarily secures the delivery device 310 to the endoscope 140 and allows for the placement of additional suture anchors 342 (suture anchors not mounted on the deployment post 350 in the delivered configuration of the access system) at a location convenient for the surgeon. The mounting portion 504 includes a support 600 adapted to be received over the endoscope adjacent the endoscope handle 602, a bracket 604 having several opposing retainers 606, and an arm 608 for displacing the bracket from the support. Additionally, an elastic band 610 is provided, which is attached to several side buttons 612 on the mounting portion 504 (FIG. 8). The suture anchors 342 are held within several disposable plugs 614 and mounted within spaces 616 on a card 618. The card 618 is mounted within the bracket 604, which is held by the retainers 606 (FIG. 21). In the card-mounted configuration, some anchors 342 are pre-threaded with sutures 346. Plugs 614 can be individually released from spaces 616 within card 618 and manually manipulated to load each suture anchor onto delivery member post 350 after delivery of the previous anchor.

[0052] In a method of use herein, the components of the access system are provided together as a kit in sterile packaging, as generally shown in FIG. 8. The kit is opened, and channel liner 480 is removed and advanced through the working channel of an endoscope. (It will be appreciated that deployment of one or more suture anchors via the delivery device will occur under endoscopic visualization.) Delivery device 310 is preloaded with suture anchor 342 at its distal end, with suture 346 securely attached to eyelet 552. As noted above, suture 346 extends rearward along delivery system 310 and is preferably pre-threaded through the eyelets of the other suture anchors.

[0053] The distal end of the delivery device 310 is advanced toward the target tissue location through the channel liner 480 in the working channel, out the tip of the endoscope. Once the tissue anchor is at the target location, the spool portion 514 is displaced toward the thumb ring 516, causing the worm gear 520, and thus the flexible shaft 522, to rotate in a direction that causes the helical coil 554 of the anchor 342 to engage the target tissue. The speed of rotation and engagement is controlled by the rate of translation of the spool portion 514 along the shaft 512 of the handle 510. If the engaged position is not ideal, the direction of the spool portion 514 can be reversed, causing rotation of the suture anchor 342 in the opposite direction, thereby disengaging the anchor from the tissue. The suture anchor 342 can then be repositioned accordingly. After the first suture anchor 342 successfully engages the tissue, the ferrule 526 is advanced relative to the handle 510. As mentioned above, in one embodiment, the advancement is accomplished by helically rotating the ferrule 526 relative to the shaft 512. As the ferrule 526 advances, the distal end 530 of the flat-wound coil 524 advances over the flexible shaft 522 and contacts the proximal end of the suture anchor 342. Further advancement of the ferrule 526 applies sufficient force to the suture anchor 342 to deploy the suture anchor 342 from the deployment post 350, thereby separating the suture anchor 342 from the delivery system 310.

[0054] The delivery system 310 is then retracted through the channel liner 480. The plug 614 with the second suture anchor 342 is removed from the card 618 and, if necessary, advanced along the suture 346 and pushed into engagement with the deployment post 350. The plug 614 is then removed from the suture anchor 342 and discarded. The delivery system 310 is then moved back down through the channel liner 480 to deploy the second suture anchor 342. This process is repeated as necessary for subsequent suture anchors until all target tissue locations have received a suture anchor. The delivery system is then finally removed from the channel liner 480, which can also be removed from the working channel of the endoscope.

[0055] The tissue approximation system 302 is then preferably used with a suitable cinch system to apply tension to the sutures, thereby drawing the implanted suture anchors together into a clamped configuration and then holding the sutures in the clamped configuration. The cinch system has numerous uses beyond this application and may be packaged with the approximation system kit or packaged separately. Exemplary suture cinch systems include those described in previously incorporated, commonly owned U.S. Pat. Nos. 8,540,735 and 9,788,831, or commonly owned U.S. Patent Application Publication No. 2017 / 0086818.

[0056] Thus, according to the next step method, the cinch system is threaded onto the suture and delivered through the working channel adjacent to the last-delivered suture anchor. Under endoscopic visualization, tension is applied to the suture, drawing the tissue anchors together to achieve the intended tissue manipulation. In most cases, the intended tissue manipulation involves approximating the tissue anchors so that the portions of the tissue associated with the anchors are in direct contact with each other to aid in the healing process. The cinch device is activated, crimping the cinch onto the suture and severing the suture, thereby securing the tissue manipulation.

[0057] All of the above allows for various tissue manipulations. In one embodiment, several anchors can be placed around a gastric defect 700, as shown in FIGS. 22 and 23. For example, the gastric defect 700 can be a submucosal resection site or a tissue perforation. The gastric defect 700 is closed by positioning four suture anchors so that the sutures extend in a zigzag configuration around the defect. The sutures are then tightened and secured with a cinch 702, as shown in FIG. 24, to approximate the surrounding tissue. In another example, shown in FIGS. 25-27, a defect 710 can be closed by placing several anchors around the defect and tightening the sutures in a "purse string" fashion. In a further example, shown in FIGS. 28 and 29, the suture anchors can be positioned partially inside the defect (FIG. 28) or completely inside the defect (FIG. 29), preferably with one or more suture anchors positioned outside the defect. Additionally, as shown in FIG. 29, suture paths 720 can extend transversely in two directions through and / or across the defect.

[0058] In yet another method, suture anchors can be used to anchor implants within the digestive tract. One such method is shown in FIG. 30 , in which several suture anchors 342 are implanted into the soft tissue on either side of a gastric feeding tube 800, and then sutures 346 are tensioned and cinch 802 are fastened to the tube. In another method, shown in FIG. 31 , suture anchors 342 are positioned through an open mesh of struts within a stent 810, and the sutures are tensioned through the anchors and cinch 802 to fasten the tensioned sutures to the tissue. In yet another method, as shown in FIG. 32 , single or multiple suture anchors 342 can be used to anchor a gastric balloon 820 to soft tissue within a stomach 822. Referring to FIGS. 33 and 34 , suture anchors 342, which can also be used individually or in an array, can also be used without sutures to endoscopically mark tissue within the digestive tract. For example, locations for further or later investigation in the stomach 832 can be marked with suture anchors 342a, 342b. The locations of the anchors can then be identified by fluoroscopic imaging, palpation, or subsequent endoscopic examination.

[0059] Described and illustrated herein are an endoscopic tissue access system for deploying one or more suture anchors, embodiments of the suture anchors, and embodiments of methods for deploying one or more anchors, securing tissue, and reconstructing tissue. While specific embodiments of the invention have been described, it is not intended that the invention be limited to specific embodiments, as the scope of the invention is as broad as the art and the specification is intended to be readable in a similar manner. It is specifically contemplated that aspects of various embodiments can be combined with one another. By way of example only, multiple barbs on the coil of one of several anchors can be provided on any of several anchors. Furthermore, the term "suture" is intended to encompass any suitable tether capable of connecting and fastening multiple anchors together and is not intended to be limiting, as it may include materials not typically considered "suture" materials. Accordingly, those skilled in the art will recognize that still other modifications can be made to the provided invention without departing from the scope of the claims. The present invention also includes the following inventions. A first aspect of the present invention is An endoscopic deployment system for placing a suture anchor at a site in a mammal, comprising: the endoscope deployment system includes: an elongate flexible delivery member having proximal, intermediate and distal regions and a proximal end and a distal end; an elongate shaft member having a proximal end and a distal end; a handle coupled to the proximal end of the shaft member, wherein rotation of the proximal end of the shaft member rotates the distal end of the shaft member; and a coupling assembly fixedly coupled to the distal region of the delivery member, the coupling assembly having an engagement post; a suture anchor having a proximal end and a distal end; a tubular receiver having a central longitudinal axis; a coil member located at the distal end; a suture eyelet rotatable relative to said tubular receiver; the delivery member having a first actuatable configuration and a second actuatable configuration; In the first operable configuration, the suture anchor is releasably coupled to the coupling assembly whereby the engagement post couples with the tubular receiver and rotation of the distal end of the shank causes the coil member of the suture anchor to engage tissue when the suture anchor is in contact with tissue; In the second actuatable configuration, the suture anchor is detached from the suture anchor and the delivery member is operable between the first actuatable configuration and the second actuatable configuration, the endoscopic deployment system. A second aspect of the present invention is The endoscopic deployment system of the first aspect, wherein the handle is operable to rotate the proximal end of the shaft member to effect rotation of the distal end of the shaft member. A third aspect of the present invention is The handle i) a stationary member defining a longitudinal slot; ii) a movable member longitudinally displaceable across said stationary member, said movable member having a drive portion received within said slot; iii) a worm gear rotatably mounted within the slot, the worm gear having a proximal end and a distal end, the drive portion of the movable member having a bore with an opening that closely accommodates the worm gear, rotating the worm gear to rotate the shaft member when the movable member is displaced over the stationary member, in the first aspect of the endoscopic deployment system. A fourth aspect of the present invention is The endoscopic deployment system of a first aspect further comprises a sheath having a proximal end and a distal end, the sheath extending over the axial member such that the distal end of the sheath is positioned proximal to the suture anchor, and the handle is operable to move the sheath distally over the axial member to remove the suture anchor from the engagement post. A fifth aspect of the present invention is In a first aspect of the endoscopic deployment system, the endoscopic deployment system further includes a suture anchor release surface positioned proximal to the suture anchor, and the handle is operable to move the suture anchor release surface distally into contact with the proximal surface of the suture anchor to disengage the suture anchor from the engagement post. A sixth aspect of the present invention is In a fifth aspect of the endoscopic deployment system, the handle is actuated to move the suture anchor release surface by manipulating a spring release or by helically advancing a coupler to which the suture anchor release surface is coupled. A seventh aspect of the present invention is The endoscopic deployment system of the first aspect, wherein the flexible delivery member is sufficiently flexible to be positioned through a tortuous path. An eighth aspect of the present invention is The endoscopic deployment system of the first aspect, wherein the flexible delivery member and the suture anchor in the first operable configuration are disposed within a lumen of an elongate sheath having a proximal end and a distal end. A ninth aspect of the present invention is a method for manufacturing a semiconductor device comprising: The endoscopic deployment system of an eighth aspect, wherein the elongate sheath is detached from the proximal handle. A tenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: An endoscopic deployment system in a first aspect, wherein the distal region of the delivery member has a first rotation key and the suture anchor has a second rotation key, and the first rotation key and the second rotation key rotationally interfere with each other. An eleventh aspect of the present invention is a method for manufacturing a semiconductor device comprising: An endoscopic deployment system in a first aspect, wherein the engagement post has at least one recess and the suture anchor has at least one tab, and when the engagement post is coupled to the tubular receiver, the at least one tab and the at least one recess rotationally interfere to cause axial rotation of the engagement post to rotate the suture anchor. A twelfth aspect of the present invention is a method for manufacturing a semiconductor device comprising: An endoscopic deployment system in a first aspect, wherein the engagement post has one of a recess and a tab, the suture anchor has the other of the recess and the tab, and when the engagement post connects to the tubular receiver, the tab and the recess rotationally interfere such that axial rotation of the engagement post causes rotation of the suture anchor. A thirteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: The endoscopic deployment system of a first aspect, wherein the suture anchor comprises a tubular member and the suture eyelet, the tubular member forming both the tubular receiver and the coil member. A fourteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1 is an endoscopic deployment system according to a first embodiment, wherein the coil member of the suture anchor is tapered. A fifteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1 is an endoscopic deployment system according to a first embodiment, wherein the coil member of the suture anchor has a variable pitch. A sixteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1. A method of deploying a suture anchor in tissue, comprising: The method comprises: a) an endoscope deployment system having a proximal end and a distal end, the endoscope deployment system comprising: i) a handle; ii) an elongate shaft member having a proximal end and a distal end and defining a longitudinal axis, the proximal end being coupled to the handle; and iii) providing an endoscopic deployment system comprising: a suture anchor removably coupled to the distal end of the shank, the suture anchor having a coil distal end with a tissue-piercing distal end, wherein rotation of the shank results in rotation of the coil, and when the distal end of the coil is brought into contact against tissue, the distal end of the coil pierces and engages the tissue; b) positioning the distal end of the endoscopic deployment system adjacent a first tissue location; c) rotating the coil about a longitudinal axis to advance the coil into engagement with the first tissue location; d) retracting the elongate shaft member to move the suture anchor away from the shaft member, thereby depositing the suture anchor at the first tissue location. A seventeenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: The method comprises: after rotating the coil about its longitudinal axis, advancing the coil to engage the first tissue location and disengaging the suture anchor from the elongate shaft member before retracting the elongate shaft member, thereby depositing the suture anchor at the first tissue location; rotating the coil in an opposite direction about the longitudinal axis to withdraw the coil from engagement with the first tissue location; repositioning the distal end of the endoscopic deployment system adjacent a second tissue location; A method according to a sixteenth aspect, comprising the step of rotating the coil about a longitudinal axis to advance the coil into engagement with the second tissue location. An eighteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: the endoscopic deployment system includes a plurality of suture anchors; The method comprises: For each suture anchor to be deployed: positioning the distal end of the endoscopic deployment system adjacent each tissue location and rotating the coil about a longitudinal axis to engage each tissue location; A method according to a sixteenth aspect, further comprising the step of retracting the axial member to move the suture anchor away from the axial member, thereby depositing the suture anchor at the respective tissue location. A nineteenth aspect of the present invention is a method for producing a medicament for a medicament comprising: connecting the plurality of suture anchors to a common suture; A method in an eighteenth aspect, comprising applying tension to a suture between the deposited suture anchors to reconfigure the first tissue position and each tissue position relative to one another, and then maintaining the tension applied to the suture. A twentieth aspect of the present invention is a method for manufacturing a semiconductor device comprising: An endoscopic suture anchor for tissue approximation, The endoscopic suture anchor for tissue approximation comprises: a coil having a proximal end and a distal end; a distal tip disposed on said distal end adapted to pierce tissue; a coupling assembly disposed at the proximal end of the coil; a suture eyelet coupled with the coupling assembly, the suture eyelet being rotatable relative to and independent of the coil; and A 21st aspect of the present invention is a method for manufacturing a semiconductor device comprising: A twentieth aspect of the present invention is an endoscopic suture anchor, wherein the coil has a longitudinal length and a uniform pitch over the longitudinal length. A 22nd aspect of the present invention is a method for manufacturing a semiconductor device comprising: In a twentieth aspect of the present invention, the coil has a longitudinal length, and the coil has at least two different pitches across the longitudinal length. A 23rd aspect of the present invention is a method for manufacturing a semiconductor device comprising: In a twentieth aspect of the endoscopic suture anchor, the coil has a longitudinal length, and the coil has a uniform diameter across the longitudinal length. A 24th aspect of the present invention is a method for manufacturing a semiconductor device comprising: In a twentieth aspect, the coil is an endoscopic suture anchor having a longitudinal length and a tapered diameter. A 25th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A twentieth aspect of the present invention is an endoscopic suture anchor, wherein the coupling assembly is integrally formed with the coil. A 26th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A twentieth aspect of the present invention is an endoscopic suture anchor, wherein the coupling assembly has a rotation key that, when rotated, results in rotation of the coil. A 27th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A twentieth aspect of the endoscopic suture anchor, wherein the coil comprises a bioactive material. A 28th aspect of the present invention is a method for manufacturing a semiconductor device comprising: The endoscopic suture anchor according to a twentieth aspect, wherein the coil comprises a hydrogel. A 29th aspect of the present invention is a method for producing a medicament for use in a pharmaceutical composition comprising: A twentieth aspect of the present invention is an endoscopic suture anchor, wherein the coil comprises a bioabsorbable material. A 30th aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1. An endoscopic suture anchor for tissue approximation, comprising: The endoscopic suture anchor for tissue approximation comprises: A tubular member, the tubular member comprising: (i) a receiver for coupling to a deployment device; (ii) a coil having a distal tip adapted to penetrate tissue; (iii) a suture eyelet ring disposed about said tubular member and forming said coil rotatable relative to said coil and independent of said coil. A 31st aspect of the present invention is a method for manufacturing a semiconductor device comprising: The endoscopic suture anchor of a thirtieth aspect, wherein the tubular member is laser cut to form tabs and open recesses for engaging structures on the deployment device. A 32nd aspect of the present invention is a method for manufacturing a semiconductor device comprising: The endoscopic suture anchor according to a thirty-first aspect, wherein at least one tab extends radially outward and at least one tab extends radially inward. A 33rd aspect of the present invention is a method for manufacturing a semiconductor device comprising: A thirtieth aspect of the present invention is an endoscopic suture anchor, wherein the coil is formed as a wall thickness of the tubular member. A 34th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A thirtieth aspect of the endoscopic suture anchor is that the coil has multiple barbs. A 35th aspect of the present invention is a method for manufacturing a semiconductor device comprising: In a method of approaching the tissue, The method comprises: a) initially engaging a first tissue anchor with tissue at a first location at least partially inside the wound; b) then engaging a second tissue anchor with the tissue at a second location, the first tissue anchor and the second tissue anchor being connected by a suture; c) applying tension to the suture between the first tissue anchor and the second tissue anchor to approximate the tissue between the first tissue anchor and the second tissue anchor; and d) securing the tensioned suture to maintain the approximation. A 36th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A method according to a thirty-fifth aspect, wherein the first tissue anchor has a tissue engaging coil, and the first engaging comprises rotationally engaging the first tissue anchor within tissue. A 37th aspect of the present invention is a method for manufacturing a semiconductor device comprising: The method of embodiment 35, wherein the second location is outside the wound. A 38th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A method according to a thirty-fifth embodiment, wherein the second location is at least partially inside the wound. A 39th aspect of the present invention is a method for manufacturing a pharmaceutical composition comprising: The method further comprises engaging at least a third tissue anchor at at least a third location; A method according to a 37th aspect, wherein the tensioning step comprises tensioning a suture between the first tissue anchor, the second tissue anchor, and at least the third tissue anchor. A fortieth aspect of the present invention is a method for producing a composition comprising: In a method of approaching the tissue, The method comprises: a) a first rotational engagement step of rotatably engaging a first coil anchor with tissue at a first position relative to the wound; b) a second rotational engagement step of rotatably engaging a second coil anchor with tissue at a second position relative to the wound; c) a third rotational engagement step of rotatably engaging at least a third coil anchor with tissue at at least a third position relative to the wound, wherein the first coil anchor, the second coil anchor, and the at least third coil anchor are connected by a suture; d) tensioning the suture between the first coil anchor, the second coil anchor, and the at least third coil anchor to approximate the tissue between the first coil anchor, the second coil anchor, and the at least third coil anchor; e) securing the tensioned suture to maintain the approximation. A 41st aspect of the present invention is a method for producing a medicament for use in a medicament comprising: A method according to a fortieth aspect, wherein prior to the tensioning step, the suture extends in a zigzag path across the wound. A 42nd aspect of the present invention is a method for producing a medicament for use in a medicament comprising: A method according to a fortieth aspect, wherein the suture extends in a path around the wound prior to the tensioning step. A 43rd aspect of the present invention is a method for producing a medicament for use in a medicament comprising: A method according to claim 40, wherein prior to the tensioning step, the sutures extend in a crossing path across the wound. A 44th aspect of the present invention is a method for producing a medicament for use in a medicament comprising: The method of the fortieth aspect, wherein the suture extends through or around an implant positioned against tissue. A 45th aspect of the present invention is a method for producing a medicament for use in a medicament comprising: The method of embodiment 40, wherein at least one of the first coil anchor, the second coil anchor, and the third coil anchor extends through an implant into tissue. A 46th aspect of the present invention is a method for producing a medicament for use in a pharmaceutical composition comprising: 1. A method of deploying a suture anchor in tissue, comprising: The method comprises: a) an endoscope deployment system having a proximal end and a distal end, the endoscope deployment system includes: i) a handle; ii) an elongate shaft member having a proximal end and a distal end and defining a longitudinal axis, the proximal end being coupled to the handle and the distal end having an engagement post; iii) a sheath having a proximal end connected to the handle and a distal end, the sheath extending over the shaft; iv) a suture anchor having a coil distal end with a tissue-piercing tip removably coupled to the engagement post at the distal end of the shank, wherein rotation of the shank results in rotation of the coil, the distal end of the coil adapted to pierce and engage tissue when the distal end of the coil is rotated relative to the tissue; b) positioning the distal end of the deployment system adjacent a first tissue location; c) rotating the coil about a longitudinal axis to advance the coil into engagement with the first tissue location; and d) advancing the sheath relative to the elongate shaft member to press the distal end of the sheath against the suture anchor, thereby disengaging the suture anchor from the engagement post, thereby depositing the suture anchor at the first tissue location. A 47th aspect of the present invention is a method for producing a medicament for use in a medicament comprising: 46. ​​The method of claim 46, wherein the sheath is longitudinally rigid. A 48th aspect of the present invention is a method for producing a medicament for use in a medicament comprising: A method according to a 46th aspect, wherein the deployment system includes a connecting member between the proximal end of the sheath and the handle, the connecting member being helically advanceable relative to the handle. A 49th aspect of the present invention is a method for producing a medicament for use in a pharmaceutical composition comprising: 1. A kit for tissue access through a working channel of an endoscope, comprising: The kit comprises: a) an endoscope deployment system, the endoscope deployment system comprising: i) a handle; ii) an elongate shaft member having a proximal end and a distal end and defining a longitudinal axis, the proximal end coupled to the handle and the distal end having an engagement post, the elongate shaft member dimensioned for insertion through the working channel of the endoscope; and b) a plurality of suture anchors, each suture anchor having a distal end of a coil with a tissue-piercing distal tip removably connectable to the engagement post at the distal end of the axial member, wherein rotation of the axial member results in rotation of the coil, and the distal end of the coil is adapted to pierce and engage tissue when rotated relative to the tissue; and c) a suture pre-extending through said plurality of anchors. A 50th aspect of the present invention is a method for manufacturing a semiconductor device comprising: A kit in a 48th aspect, wherein one of the suture anchors is mounted on the engagement post and at least one of the suture anchors is provided in a device for separate handling and subsequent mounting on the engagement post. A fifty-first aspect of the present invention is a method for manufacturing a semiconductor device comprising: A kit according to a fiftieth aspect, wherein a plurality of suture anchors are held in respective holders, and the respective holders are mounted on a card. A 52nd aspect of the present invention is a method for manufacturing a semiconductor device comprising: A kit in a 51st aspect, further comprising an endoscope bracket suitable for connecting the deployment system to the endoscope, the endoscope bracket supporting the card. A 53rd aspect of the present invention is a method for manufacturing a semiconductor device comprising: A kit in a 49th aspect, further comprising a channel liner suitable for extending through the working channel of the endoscope prior to insertion of the deployment system and suitable for forming a barrier between the deployment system and the working channel when the deployment system is subsequently inserted into the working channel.

Claims

1. An endoscopic deployment system for placing a suture anchor at a site in a mammal, comprising: the endoscope deployment system includes: a delivery member having proximal, intermediate and distal regions and a proximal end and a distal end; an elongate shaft member having a proximal end and a distal end; a first rotary key in the distal region of the delivery member; a coupling assembly fixedly coupled to the distal region of the delivery member and having an engagement post; a suture anchor having a proximal end and a distal end, the suture anchor comprising: a receiver having a central longitudinal axis; a coil member located at the distal end of the suture anchor; and a second rotation key; the first rotary key and the second rotary key rotationally interfere with each other, the delivery member is actuatable between a first actuatable configuration and a second actuatable configuration; when the delivery member is in the first operable configuration, the suture anchor is releasably coupled to the coupling assembly whereby the engagement post couples with the receiver and rotation of the distal end of the elongate shaft member causes the coil member of the suture anchor to engage tissue when the suture anchor is in contact with the tissue; the suture anchor is removed from the coupling assembly when the delivery member is in the second operable configuration; the endoscope deployment system includes: a suture anchor release surface disposed proximally relative to the suture anchor; a handle operable to move the suture anchor release surface distally into contact against a proximal face of the suture anchor to disengage the suture anchor from the engagement post.

2. An endoscopic deployment system for placing a suture anchor at a site in a mammal, comprising: the endoscope deployment system includes: a delivery member having proximal, intermediate and distal regions and a proximal end and a distal end; an elongate shaft member having a proximal end and a distal end; a first rotary key in the distal region of the delivery member; a coupling assembly fixedly coupled to the distal region of the delivery member and having an engagement post; a suture anchor having a proximal end and a distal end, the suture anchor comprising: a receiver having a central longitudinal axis; a coil member located at the distal end of the suture anchor; and a second rotation key; the first rotary key and the second rotary key rotationally interfere with each other, the delivery member is actuatable between a first actuatable configuration and a second actuatable configuration; when the delivery member is in the first operable configuration, the suture anchor is releasably coupled to the coupling assembly whereby the engagement post couples with the receiver and rotation of the distal end of the elongate shaft member causes the coil member of the suture anchor to engage tissue when the suture anchor is in contact with the tissue; the suture anchor is removed from the coupling assembly when the delivery member is in the second operable configuration; The endoscopic deployment system, wherein the engagement post has one of a recess and a tab, and the suture anchor has the other of the recess and the tab.

3. The endoscopic deployment system of claim 2 , wherein when the engagement post couples to the receiver, the tab and the recess rotationally interfere such that axial rotation of the engagement post results in rotation of the suture anchor.

4. 3. The endoscope deployment system of claim 2, further comprising a handle operable to rotate the proximal end of the elongate shaft member to effect rotation of the distal end of the elongate shaft member.

5. The endoscopic deployment system of claim 4 , wherein the coil member has a sharpened tip such that rotation of the distal end of the elongate shaft member causes the coil member to pierce and engage tissue.

6. 3. The endoscopic deployment system of claim 2, wherein the suture anchor further comprises a suture eyelet for attachment of a suture and is rotatable relative to the coil member such that axial rotation of the coil member does not result in axial rotation of the suture eyelet.

7. 7. The endoscopic deployment system of claim 6, further comprising a suture secured to the suture eyelet, wherein rotation of the suture eyelet relative to the coil member prevents tangling of the suture.

8. 8. The endoscopic deployment system of claim 6 or 7, wherein the suture eyelet is positioned around the receiver of the suture anchor distal to the second rotation key and proximal to the coil member.

9. The endoscope deployment system of claim 2 , wherein the second rotary key is fixedly coupled to the receiver.

10. The endoscope deployment system of any one of claims 2 to 9, wherein the engagement post includes the first rotation key.

11. An endoscopic deployment system for placing a suture anchor at a site in a mammal, comprising: the endoscope deployment system includes: a delivery member having proximal, intermediate and distal regions and a proximal end and a distal end; an elongate shaft member having a proximal end and a distal end; a first rotary key in the distal region of the delivery member; a coupling assembly fixedly coupled to the distal region of the delivery member and having an engagement post; a suture anchor having a proximal end and a distal end, the suture anchor comprising: a receiver having a central longitudinal axis; a coil member located at the distal end of the suture anchor; and a second rotation key; the first rotary key and the second rotary key rotationally interfere with each other, the delivery member is actuatable between a first actuatable configuration and a second actuatable configuration; when the delivery member is in the first operable configuration, the suture anchor is releasably coupled to the coupling assembly whereby the engagement post couples with the receiver and rotation of the distal end of the elongate shaft member causes the coil member of the suture anchor to engage tissue when the suture anchor is in contact with the tissue; the suture anchor is removed from the coupling assembly when the delivery member is in the second operable configuration; the engagement post extends distally from the distal end of the elongate shaft member and includes an engagement post head having a tapered distal end configured to be inserted into the receiver.

12. the engagement post extends distally from the distal end of the elongate shaft member and includes an engagement post head having a tapered distal end configured to be inserted into the receiver; The endoscope deployment system of claim 2 , wherein the first rotation key is positioned on the engagement post proximal to the engagement post head.

13. 3. The endoscopic deployment system of claim 2, further comprising a suture eyelet for attachment of a suture, the suture eyelet rotatable relative to the coil member proximal to the coil member and rotatably disposed about the retainer distal to the second rotation key.

14. The endoscopic deployment system of claim 1 , wherein the delivery member is sufficiently flexible to extend through tortuous paths within a patient.

15. The endoscope deployment system of claim 11 , wherein the delivery member is sufficiently flexible to extend through tortuous paths within a patient.

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