Endoscopic tissue approach system and method

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] The present application claims priority to U.S. Patent Application Serial No. 16 / 701,276 filed December 3, 2019, U.S. Provisional Application Serial No. 62 / 928,516 filed October 31, 2019, and U.S. Provisional Application Serial No. 62 / 775,542 filed December 5, 2018, all of which are hereby incorporated by reference in their entireties into this specification.

[0002] The present disclosure relates to surgical instruments and methods. More particularly, the present disclosure relates to instruments for deploying fasteners and hemostatic clips, as well as suturing methods and apparatus for use in endoscopic, laparoscopic, and other surgically effective or minimally invasive procedures.

Background Art

[0003] Numerous pathologies requiring intervention occur in the gastrointestinal tract, including bleeding and perforation of the gastrointestinal ("GI") tract. Gastrointestinal bleeding is often associated with peptic ulcer disease and can be fatal if left untreated. When an event occurs that raises suspicion of gastrointestinal bleeding in a patient, an endoscopist can perform diagnostic endoscopy to identify the lesion and determine the best course of treatment. From an endoscopic standpoint, the endoscopist has several options available for treating the patient. For minor bleeding, the endoscopist can use thermal coagulation to ablate the lesion and achieve hemostasis. Thermal coagulation therapy is typically used for well-identified localized lesions and carries a risk of causing perforation with the ablation probe. Rebleeding is a common outcome with this treatment modality.

[0004] Another method for achieving hemostasis involves the use of endoscopically positioned hemostatic clips. When properly positioned, hemostatic clips apply compressive force to the bleeding site, causing hemostasis. While clips are easy to use, precisely positioning them relative to the lesion is difficult, 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 perforations. Furthermore, each clip is small and has a surface area that acts only on a localized area of ​​tissue.

[0005] Another method for endoscopically controlling gastrointestinal bleeding is to use suturing devices, such as the system disclosed in Patent Document 1 by Gilkey et al. (U.S. Patent No. 8,287,556). This suturing device is connected to a dual-channel endoscope and allows for interrupted or continuous suturing. The bleeding site can be sutured and tightened to stop the bleeding. Furthermore, if the bleeding is accompanied by perforation, the suturing device can be used to suture and close the perforation. While this can suppress gastrointestinal bleeding, this suturing system is quite complex and must be used with a specialized dual-channel therapeutic endoscope that is not widely available. Therefore, a less complex solution is needed for the treatment of gastrointestinal bleeding and perforation.

[0006] Other gastrointestinal procedures, such as anastomosis formation, closure of perforations in the gastrointestinal tract, and tissue reconstruction for ulcer treatment, require the ability to precisely and selectively target the intended tissue for reconstruction or approach while excluding unintended tissues and organs. These requirements also hinder other endoscopic procedures, including those involving the stomach and other organs. For example, many effective surgical procedures have been developed to control gastroesophageal reflux disease. Exemplarily, one of these procedures involves creating a ring around the proximal stomach that acts as a barrier to the dissolution of the lower esophageal sphincter. However, when these procedures are performed endoscopically, the limitations of endoscopic suturing make the procedure difficult.

[0007] One solution is proposed in Patent Document 2 by Filipi et al. (U.S. Patent Application Publication No. 2007 / 0276408), which describes a device that is removable or permanently attached to the end of an endoscope or manufactured integrally with the endoscope. The device has a belt with a number of slots carrying a number of T-fasteners arranged in a circumferential direction. These T-fasteners are connected to each other by continuous sutures. The belt can be rotated around the end of the endoscope, so that the number of slots and T-fasteners are moved to align with a push rod positioned within the working channel of the endoscope. When the push rod is activated, the aligned T-fasteners can be advanced from the belt into the tissue, but the deployed T-fasteners remain connected to the sutures. After each deployment of a T-fastener, the belt is rotated to displace adjacent T-fasteners to align with the push rod, and the push rod is activated again to deploy subsequent T-fasteners. This process is repeated to deploy additional T-shaped fasteners. After deploying the T-shaped fasteners within the tissue, tension is applied to the sutures to pull and tighten the constricted tissue, maintaining tension and permanently reducing the space between the fasteners. Thus, in one procedure, gastric capacity can be reduced to treat obesity, and in another procedure, the lower esophageal sphincter can be reinforced to reduce gastroesophageal reflux.

[0008] However, Filipi et al.'s system has several drawbacks that make its use impractical. Firstly, in various embodiments, the system may require modification of a standard endoscope, either by permanent attachment or by the integrated manufacture of the system at its distal end. However, surgeons are known to prefer using endoscopes they are familiar with and are unlikely to readily permanently modify an endoscope that would be very expensive for a limited use. Secondly, in all embodiments, the system has a larger diameter than the end face of a standard endoscope. As a result, it becomes a bulky instrument that is difficult to handle and has poor maneuverability when operating in narrow spaces or small body cavities. Thirdly, the system requires that the mounted belt and all fasteners be driven by rotational motion at the distal end of the endoscope, and that the belt and each subsequent T-fastener be advanced and aligned with a push rod for deploying the T-fasteners. Such mechanical motion is difficult to operate at the distal end of the endoscope. If the alignment is incorrect, the T-fasteners may not deploy or may be used incorrectly. Fourth, the T-fasteners are positioned without knowing what tissue lies behind the target tissue. Therefore, the deployed T-fasteners may puncture unintended tissue behind the target tissue, causing damage. Fifth, in practice, this system seems to require all T-fasteners loaded in the belt slots to be deployed before the endoscope is pulled away from the excess suture to secure the suture with the scintigraphy. 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] U.S. Patent Application Publication No. 2007 / 0276408 [Overview of the project]

[0010] This specification provides a suture anchor, an arrangement of multiple suture anchors, a deployment system for deploying one or more suture anchors into tissue together with sutures, and a method for doing so. A suture anchor is a type of fastener having a helical portion suitable for engaging with and being retained by tissue. A suture anchor has a distal helical portion and a proximal receiving portion. A suture anchor has a longitudinal axis extending through the receiving portion and the helical portion. A suture eyelet is fixedly connected to the suture anchor between the proximal and distal portions and is rotatable around the longitudinal axis of the suture anchor. The suture anchor receiving portion has a tubular member having a retaining member suitable for engaging with a post member of the deployment system, the retaining member engaging with the post member when the post member of the deployment system is inserted into the receiving portion, and the suture anchor is held on the deployment system. The helical portion of the suture anchor is typically formed from a coiled wire having a sharp tip, which, when rotated, perforates the tissue and engages with it. The coiled wire is preferably formed from a biocompatible and implantable material. Numerous suitable materials exist, including metals such as stainless steel and cobalt-chromium (CoCr), nylon®, polyetheretherketone (peek), polyethylene terephthalate (PET), acrylonitrile butadiene styrene (ABS), polycarbonate, PDO, PGA, PCL, mixtures, and biodegradable materials such as bioglass. The elongated suture, having proximal and distal ends, is fixedly connected to a suture eyelet, and the rotation of the suture anchor by the attached deployment system rotates the receiving portion and the helical portion without rotating the eyelet portion on the deployment system, so as not to wrap around or tangle the elongated suture.

[0011] Multiple similar suture anchors may be used to perform tissue reconstruction procedures. Further suture anchors are attached to the suture through suture fixing eyelets, with the distal end of the suture fixed to a first suture anchor. The distal end of the suture is provided with an end structure that restricts its movement relative to the suture holder of the most distal first suture anchor. This end structure may have an enlarged node or an attached bead that functions as a stopper for the suture holder. Alternatively, the end structure may be directly attached to the suture holder by tying it to the holder.

[0012] A suture anchor is provided having a proximal portion and a distal portion in the form of a coil. The distal portion of the coil has a sharp tip that can perforate tissue. The coil has a longitudinal length preferably selected for the tissue in which it is to be placed. For example, the thickness of gastric tissue may range from 5 mm to 8 mm, including the mucosal and muscular layers. The corresponding suture anchor coil portion may have a longitudinal length of about 8 mm, so that when the tissue is engaged by the coil portion, the coil portion can be securely fixed to the muscular layer without extending through the gastric wall and engaging with tissue beyond the gastric wall. In another example, the suture anchor has a length suitable for use in the colon. Typically, colonic tissue may have a thickness of about 0.2 mm to 5 mm, including the mucosal and muscular layers. The corresponding suture anchor coil suitable for colonic tissue may have a longitudinal length of about 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 including a beneficial covering. The covering may be in the form of a swellable material. For example, if a suture anchor coil (without a beneficial covering) is fixed in tissue, the distal portion of the coil, together with the more proximal portion of the following coil, perforates the tissue. This process expands the pathway in the tissue taken by the coil, and the suture anchor may be loosely fixed to the tissue. With a suture anchor coil having a swellable covering, the loosely fixed suture anchor becomes more firmly fixed as the covering expands and fills the expanded pathway created by the coil. Furthermore, if the coil portion of the suture anchor extends beyond the tissue wall, the swellable covering will reduce or eliminate the risk of fluid passing through the pathway created by the suture anchor. Alternatively, the beneficial covering may have therapeutic compounds or drugs such as antibacterial, antifungal, antiviral, and antibiotics to prevent or minimize infection. Other forms of beneficial coverings may include therapeutic compounds or substances that can accelerate the healing response of the associated tissue and defect.

[0014] A suture anchor deployment system is provided for deploying multiple consecutive suture anchors in surgical procedures. The deployment system is preferably suitable for endoscopic or laparoscopic use, but can also be used in open surgery.

[0015] The deployment system comprises a proximal handle, a delivery member having a proximal and distal end rotatably connected 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, torque-transmitting shaft. The elongated shaft can be formed from a flexible cable, wire, tubular catheter, or sophisticated structure, as described in U.S. Patent No. 10,238,411, jointly published by Mitelberg et al. The suture anchor is detachably connected to the delivery member post for delivery to a target site. The deployment system may also have a sheath extending over the delivery member and the attached suture anchor to prevent the sharp end of the suture anchor from damaging the flexible endoscope channel when delivering the suture anchor to a target site in the body. The sheath may be retractably connected to the deployment system and may be a separate liner inserted through the endoscope's instrument channel, acting as a protective barrier between the sharp portion of the suture anchor and the wall of the instrument channel. Once the suture anchor is positioned adjacent to the target tissue site, operating the handle rotates the elongated shaft, causing the helical portion of the suture anchor to rotate, thereby engaging with the tissue at the target site. After engaging with the tissue, if another target site is selected, the handle is operated 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 to the new target site and rotationally engaged with the tissue. Once the suture anchor is properly positioned, the suture anchor and the delivery member post can be moved relative to each other to separate the delivery member post from the suture anchor. A second sheath, which extends along the elongated shaft but not along the suture anchor, can be advanced along the elongated shaft, and the distal end of the second sheath applies force to the proximal end of the suture anchor, separating the suture anchor from the delivery member post. Once the first suture anchor has been deployed to the target site, the second suture anchor, which engages with the post member of the delivery member, can be reloaded into the deployment system. As mentioned above, the second suture anchor is attached to a long suture thread through a suture eyelet.Next, the second suture anchor can be positioned at the target site and rotated to engage with the tissue (without the suture wrapping around the delivery member). After the deployment of the second suture anchor, further suture anchors can be loaded into the delivery member and deployed as needed. Once the last suture anchor is deployed, a tightening device can be attached to the suture (as disclosed in U.S. Patent No. 8,540,735 by Mitelberg et al., incorporated herein by reference) and used to apply appropriate tension to the suture (pulling the suture anchor and associated tissue together) to reconstruct the tissue, and then used to maintain tension and cut off excess suture.

[0016] Further suture anchors can be detachably attached to a card or other component to be attached to the endoscope. In the attached configuration, the suture anchors are pre-attached with sutures. Each suture anchor is provided on a removable plug that can be individually released from the card and operated to load the suture anchor into the delivery member post.

[0017] In one embodiment, the delivery member and the attached suture anchor are sized to extend into the working channel of the endoscope. In the same embodiment, the delivery member and any sheath are all flexible enough to be used in the working channel of an endoscope that extends through a winding path, particularly in the working channel of a curved endoscope.

[0018] For use, the deployment system, loaded with the first suture anchor, is advanced through the working channel of the endoscope or lumen, or pre-positioned within the working channel. In one method, the endoscope is positioned in a natural bodily cavity such as the stomach or esophagus, with the distal end of the endoscope positioned in the stomach. The distal end of the deployment system is advanced from the working channel, the sheath protecting the distal end of the suture anchor is retracted, and the most distal end of the suture anchor is positioned relative to the first target tissue location where the first suture anchor is to be deployed. When 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 perforates and engages with the tissue. If the position of the suture anchor is satisfactory, the suture anchor is removed from the deployment system and left in its tissue engagement position.

[0019] Next, the deployment system is removed from the endoscope's operating channel, and a second suture anchor is loaded into the distal end of the deployment system. Then, the deployment system is reinserted into the endoscope's operating channel, and the distal end of the deployment system is moved to the second target tissue location. This process is repeated to engage with the tissue and deploy the next suture anchor. This process is repeated as needed to position multiple suture anchors at various locations suitable for the treatment procedure.

[0020] Suture anchors can be deployed in various patterns, allowing for diverse tissue access. For example, they can be positioned in zigzag, rectangular, or circular patterns, or partially inside and partially outside the defect, after which the scintigraphy can be tightened to close the defect. Furthermore, suture anchors can be deployed to secure implants such as feeding tubes, stents, and gastric balloons, and can also be used as markers without suturing.

[0021] Once the suture anchor is deployed within tissue, the deployment system can be withdrawn from the actuation channel over the suture. A tightening device is advanced over the suture, preferably through the same actuation channel. Tension is applied to the suture, and the suture is drawn through the suture anchor, thereby bringing the first, second and other target tissue locations into close contact. Once appropriate tension is applied to achieve tissue reconfiguration, a cinch is secured to the suture and retained in the tissue reconfiguration. Alternatively, no cinch is required, and the suture may be knotted to maintain the tension.

[0022] The suture anchor deployment system provides several advantages. The suture anchor deployment system can be deployed through the actuation channel of a conventional endoscope, with no need to modify the endoscope. The deployment system does not increase the overall diameter of the distal end of the endoscope. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] [Figure 1] FIG. 1 is a broken side view of a suture anchor deployment system. [Figure 2] FIG. 2 is a partially enlarged cross-sectional side view of the distal portion of the suture anchor deployment system. [Figure 3] FIG. 3 is an enlarged side view of a suture anchor extending from a distal end sheath of the suture anchor deployment system. [Figure 4A] FIG. 4A is an enlarged side view of a distal end of a delivery member and a suture anchor. [Figure 4B] FIG. 4B is an enlarged perspective view of a distal end of a delivery member and a suture anchor. [Figure 4C] FIG. 4C is a partially cross-sectional perspective view of an enlarged view of a delivery member and a suture anchor. [Figure 5A] FIG. 5A is an enlarged partial cross-sectional side view of a distal end of a delivery member and a suture anchor according to an alternative embodiment. [Figure 5B] FIG. 5B is an enlarged partial cross-sectional view of a distal end of a delivery member and a suture anchor according to another alternative embodiment. [Figure 6A] FIG. 6A is an enlarged view of a suture anchor according to yet another embodiment. [Figure 6B] Figure 6B is a cross-sectional side view of the suture anchor portion of the embodiment shown in Figure 6A. [Figure 7A] Figure 7A shows the use of a suture anchor deployment system, with the distal end of the deployment system extending through an endoscope adjacent to the tissue having a tissue defect. [Figure 7B] Figure 7B shows the use of a suture anchor deployment system, illustrating a retracted deployment system that exposes connected suture anchors. [Figure 7C] Figure 7C shows the use of a suture anchor deployment system, illustrating the rotation of the deployment system such that the suture anchor engages with the tissue in a first position. [Figure 7D] Figure 7D shows the use of a 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 the endoscope. [Figure 7E] Figure 7E shows a placement system for the use of a suture anchor deployment system, the system having a second suture anchor positioned adjacent to the location of a second tissue. [Figure 7F] Figure 7F shows the use of a suture anchor deployment system, with a second suture anchor engaging with the tissue in a second position after being removed from the deployment system. [Figure 7G] Figure 7G shows the use of a suture anchor deployment system, illustrating how tension is applied to the suture so that the suture anchor closes the tissue defect. [Figure 7H] Figure 7H shows the use of a suture anchor deployment system, illustrating a tissue defect closed using close suture anchors maintained under tension applied using a scintillator. [Figure 8] Figure 8 is a top perspective view of the suture anchor deployment kit. [Figure 9A] Figure 9A is a side elevation view of a suture anchor deployment system according to another embodiment. [Figure 9B] Figure 9B is a longitudinal cross-sectional view of the suture anchor deployment system along line 9B-9B in Figure 9A. [Figure 10] Figure 10 is a partially transparent side elevation view of the distal end of the delivery device of the suture anchor deployment system of Figure 9A, shown without the suture anchor and sutures. [Figure 11] Figure 11 is a partially transparent side elevation view of the distal end of the delivery device of the suture anchor deployment system of Figure 9A, showing the suture anchor and suture thread. [Figure 12] Figure 12 is a longitudinal cross-sectional view along line 12-12 in Figure 11. [Figure 13] Figure 13 is a side elevation view of a suture anchor according to one embodiment. [Figure 14] Figure 14 is an end view of the suture anchor according to the embodiment shown in Figure 13. [Figure 15] Figure 15 is a side elevation view of a laser-cut tubular element of a suture anchor according to one embodiment. [Figure 16] Figure 16 is a side elevation view of an eyelet ring for a suture anchor according to one embodiment. [Figure 17] Figure 17 is an end view of the eyelet ring shown in Figure 16. [Figure 18] Figure 18 is a side elevation view of a laser-cut tubular element for a suture anchor in another embodiment. [Figure 19] Figure 19 shows an endoscope equipped with a mounting section for a suture anchor deployment system. [Figure 20] Figure 20 shows a card that stores a plug to hold additional suture anchors. [Figure 21] Figure 21 is a diagram of the card shown in Figure 20, which is attached to the mounting part in Figure 19. [Figure 22] Figure 22 shows a method for correcting a defect in the digestive tract using a suture fixation system. [Figure 23] Figure 23 shows a method for correcting a defect in the digestive tract using a suture fixation system. [Figure 24] Figure 24 shows a method for correcting a defect in the digestive tract using a suture fixation system. [Figure 25]Figure 25 shows another method using a suture anchor deployment system to correct defects in the gastrointestinal tract. [Figure 26] Figure 26 shows another method using a suture anchor deployment system to correct defects in the gastrointestinal tract. [Figure 27] Figure 27 shows another method using a suture anchor deployment system to correct defects in the gastrointestinal tract. [Figure 28] Figure 28 shows another method using a suture anchor deployment system to correct defects in the gastrointestinal tract. [Figure 29] Figure 29 shows another method using a suture anchor deployment system to correct defects in the gastrointestinal tract. [Figure 30] Figure 30 shows a method for implanting a feeding tube into the digestive tract using a suture anchor deployment system. [Figure 31] Figure 31 shows a method for implanting a stent in the digestive tract using a suture anchor deployment system. [Figure 32] Figure 32 shows a method for implanting a gastric balloon into the digestive tract using a suture anchor deployment system. [Figure 33] Figure 33 shows a method for marking tissue areas in the digestive tract using a suture anchor deployment system. [Figure 34] Figure 34 shows a method for marking tissue areas in the digestive tract using a suture anchor deployment system. [Modes for carrying out the invention]

[0024] Refer to the following description; the terms “proximal” and “distal” are defined relative to the user’s hand of the device, with “proximal” being closer to the user’s hand and “distal” being further away from the user’s hand, often being further away within the patient’s body during use. Furthermore, the system is provided and used to target tissue, deploy suture anchors into the tissue, and reconstruct the fixed tissue, in accordance with the general description of the system and its exemplary use, which is described in detail below. The above targeting, fixation, and reconstruction are not necessarily performed with a surgical scope such as a laparoscope or endoscope, but are preferably performed together. In the embodiments described herein, in order to allow the passage of the necessary instruments, the instrument acting to reconstruct the tissue may be inserted through a lumen, i.e., the gastroesophageal pathway, preferably through or using an endoscope inserted without incision into either the patient’s skin tissue or internal tissue. Specifically, it is recognized that perforating tissue to insert fasteners does not involve making an incision in the tissue.

[0025] Referring to Figures 1 to 3, one embodiment of the tissue access system 2 is shown. The tissue access 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 access system 2 is particularly suitable for endoscopic access to soft tissue catheter systems in the gastrointestinal tract. The tissue access system 2 comprises a plurality of tissue anchors 42, an anchor delivery system 10 for embedding the anchors 42 at each tissue location in the gastrointestinal tract, and a suture element 46 for joining the plurality of tissue anchors 42. The tissue access system 2 preferably further comprises a suture scintigraphy system for applying tension to the suture 46, thereby pulling the plurality of embedded tissue anchors 42 toward each other and further holding the suture 46 in a tightened configuration, as described in U.S. Patent No. 8,540,735 and U.S. Patent No. 9,788,831 or U.S. Patent Application Publication No. 2017 / 0086818, which are incorporated herein in their entirety by reference.

[0026] In one embodiment, the delivery system 10 has an elongated 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 through it. A delivery member 30 having a distal end 32 and a proximal end 34 is slidably positioned within the lumen 26 of the sheath member 20. The delivery member 30 takes the form of an elongated, flexible, torque-transmitting shaft having a handle member 40 connected to the proximal end 34. The delivery member 30 is preferably formed in the form of a cable, however, other torque-transmitting components, such as those found in catheters and guidewires, may also be suitable. A suture anchor 42 is detachably connected to the distal end 32 of the delivery member 30. The suture anchor 42 has a distal end 44 and a proximal end 45 and is connected to an elongated suture 46. The suture thread 46 has a distal end 47 connected to the suture anchor 42 and a proximal end 48 adjacent to the proximal region 14 of the system 10.

[0027] Figures 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 rotating key 52. ​​The rotating key 52 of the delivery member is suitable for engaging with the anchor rotating 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 positioned 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, blend, and bioglass may also be suitable.

[0029] The wire used to form the coil is preferably round, but other non-circular cross-sections such as "D" shape, oval (elliptical), rectangular, triangular, and polygonal shapes may also be suitable for forming the coil. The wire diameter can range from 0.025 mm (0.001 inches) to about 1.27 mm (about 0.050 inches) and depends largely on the specific tissue characteristics to which the coil will engage. The coil diameter generally depends on the wire diameter and the diameter of the mandrel used for winding. The coil diameter can generally range from 0.76 mm (0.030 inches) to about 3.8 mm (about 0.150 inches) and also depends on the type of tissue and the dimensions of the endoscope channel. The suture anchor 42 located proximal to the coil 60 also has a collar 68 fixedly connected to a suture eyelet 70. The collar 68 and suture eyelet 70 are configured to be rotatable around the longitudinal axis of the suture anchor. The suture eyelet 70 is preferably connected to the distal end 47 of the suture thread 46 and held in place by a knot 72 or by other uniform means such as adhesion or thermoforming.

[0030] Figures 4A-4C show various enlarged views of the distal end of the delivery member 30 and the removed suture anchor 42. As shown in Figure 4A, the engagement post 50 of the delivery member 30 has an engagement post head 80 having 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. Figure 4C shows the alignment of the engagement post 50 and the suture anchor 42 before engagement. The suture anchor 42 has an engagement receiving portion 90 extending proximal to the coil 60, the distal portion 92 being fixed to the proximal end 64 of the coil, preferably by laser welding or other suitable joining technique. The proximal portion 94 of the engagement receiving portion 90 is shown adjacent to the anchor rotation key 54. The engagement receiving portion 90 is a tubular member and has a retaining tab 96 cut from the wall. The retaining tab 96 is usually angled toward the central axis of the engagement receiving portion. The retaining tab 96 functions as a living hinge, so that when the engaging post head 80 is inserted into the receiving portion 90, the tab 96 is deflected upward, allowing the head 80 to pass through the tab 96. Subsequently, the retaining tab 96 moves to a right-angle position, in contact with the engaging post neck 84. This arrangement of the retaining tab between the post head and post neck, when engaged, detachably connects the suture anchor and the delivery member. The anchor rotation key 54 is preferably fixedly connected to the engaging receiving portion 90 by welding or other suitable joining technique.

[0031] The configuration of an alternative embodiment of the suture anchor 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. The anchor 100 has a proximal engagement receiving portion 102 and a distally positioned coil 104. An anchor rotation key 106 is fixedly connected to the engagement receiving portion 102. The collar 108 and suture eyelet 110 are distal to the rotation key 106 and proximal to the coil proximal end 112, and are positioned on and rotatable on the engagement receiving portion 102. The coil 104 has a distal end 114 with a sharp distal end 116. The coil 104 is fixedly connected to the engagement receiving portion 102 via a spacer member 118. The spacer member 118 is preferably welded to the receiving portion 102 and the coil proximal end 112. The proximal end 112 of the coil has a closer winding pitch than the distal end 114, facilitating attachment to the receiving portion 102. The distal end 114 has a considerably wider pitch so that the coil can easily engage with the tissue when rotated. The spacer member 118 is formed from a biocompatible material, and by modifying the suture anchor, a coil with a diameter considerably larger than the diameter of the engagement receiving portion can be used. If the diameter of the coil and coil pitch can be varied, suture anchors suitable for different tissue stiffness and thickness can be created.

[0032] Figure 5B shows a suture anchor 120 with a structure similar to that of the suture anchor 100. The anchor 120 has a proximal engagement receiver 122 and a distally positioned coil 124. An anchor rotation key 126 is fixedly connected to the engagement receiver 122. The collar 128 and suture eyelet 130 are positioned on the engagement receiver 122, distal to the rotation key 126 and proximal to the proximal end 132 of the coil, and are rotatable around the engagement receiver 122. The coil 124 has a distal end 134 with a sharp distal tip 136. The coil 124 is fixedly connected to the engagement receiver 122 via a spacer member 138. The spacer member 138 is preferably welded to the receiver 122 and the proximal end 132 of the coil. As shown in Figure 5B, the coil 124 tapers toward the distal tip 136. This tapering can be helpful in deploying the suture anchor 120 in dense or tough tissue.

[0033] Referring to Figures 6A and 6B, another embodiment of a suture anchor having a configuration similar to the previous suture anchor 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 perforating tissue. The proximal region 206 has a cross member 210 that roughly 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 shaft 214, having a distally located suture eyelet 216 and a proximally located retaining bead 218, is positioned through the opening 212. As shown in Figures 6A and 6B, the suture eyelet 216 is positioned inside 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 shaft 214 relative to the crossing member 210. The sliding ability of the eyelet shaft and the rotational ability of the suture eyelet are important features for the successful placement of the suture anchor 200. Deployment of the suture anchor 200 requires a deployment system similar to the deployment system 10, with some modifications. The engagement post of the delivery member will be modified to have a "D" shape to engage with the "D" shape formed by the crossing member (not shown in the figure). This configuration allows the suture anchor to be placed on the engagement post, but further retaining functions can be added to make the engagement between the delivery member and the suture anchor more secure. Other embodiments of suture anchors are described below.

[0034] When used at a target tissue site, the suture anchor positioned on the delivery member has an elongated suture thread secured to a suture eyelet. In one embodiment, the suture is a 3-0 polypropylene suture, but may be any other suitable suture material, including polymer monofilaments, polymer multifilaments, polymer braids, metal wires, metal multistrand configurations, metal braids, polymer and metal combinations, natural biomaterials, and any other suitable suture material.

[0035] When the handle of the delivery member is rotated, the engagement post rotates, causing the coil of the suture anchor to rotate. As the coil rotates, the distal end of the coil engages with the tissue and advances deeper into the tissue. The suture, secured to the suture eyelet, follows the spiral gap between the coil windings as the coil rotates within the tissue. When the suture eyelet is in contact with the tissue, the suture eyelet remains largely stationary as the rotating proximal coil end approaches the suture eyelet. The rotational capability of the suture eyelet prevents the suture adjacent to the deployment system from wrapping around or becoming entangled with the delivery member. The sliding capability of the eyelet shaft allows the suture eyelet to move from the distal end of the coil to the proximal end of the coil, meaning that the coil is completely fixed within the tissue.

[0036] Here, according to one method using the deployment system 10 (the other method will be described below), the endoscope is advanced through a natural bodily opening such as the stomach or esophagus, and the distal end of the endoscope is positioned within the body cavity such as the stomach. The distal portion of the deployment system 10 is advanced through the working channel of the endoscope, or is pre-positioned within the working channel of the endoscope. Alternatively, the deployment system can be advanced through a peripheral tube located outside the endoscope.

[0037] Referring to Figures 7A, 7B, and 7C, it is clear that the distal end of the deployment system extends from the working channel of the endoscope 140, the sheath is retracted, and the first suture anchor 42 is fixedly connected to a suture 46 positioned near the target tissue adjacent to the gastrointestinal defect 142. The gastrointestinal defect 142 may incorporate a mucosal layer 144 or protrude more deeply to include a muscular layer 146. The distal end of the first suture anchor 42 is positioned relative to the first target tissue location 148 where the first suture anchor is to be placed. When the coil portion of the suture anchor 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 perforate and engage with the tissue. Once the first suture anchor 42 is properly positioned, the first suture anchor 42 is then removed from the delivery member 30 and left fixed in the tissue. If the placement of the first suture anchor is unsatisfactory, the delivery member can be rotated in the opposite direction to rotate the coil of the suture anchor in the opposite direction, disengaging it from the tissue, and the suture anchor can be repositioned and deployed in a different location.

[0038] After deploying the first suture anchor, the deployment system 10 is removed from the operating channel of the endoscope 140, and the second suture anchor 42 (slidably connected to the suture 46) is connected to the distal end of the deployment system. Next, the deployment system is reinserted into the endoscopic operating channel, and the distal end of the deployment system is moved to the second target tissue position 150. This process is repeated to engage with the tissue and deploy the second suture anchor 42, as shown in Figures 7D, 7E, and 7F. This process can be repeated as needed to deploy further suture anchors (slidably connected to the suture 46) at various positions suitable for the treatment procedure.

[0039] As shown in Figures 7G and 7H, once the suture anchor is deployed into the tissue, the deployment system can be withdrawn from the operating channel. Next, a tightening device (not shown in the figure) is advanced along the suture to the last deployed suture fixation site. Then, tension is applied to the suture 46, pulling it through the suture anchor, resulting in close contact with 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 the defect 142), the scintillator 152 is secured to the suture and holds the tissue reconstruction in place.

[0040] Referring to Figure 8, another embodiment of the tissue access system 302 is shown. The tissue access system 302 comprises an anchor delivery device 310 for delivering a plurality of anchors 342 (one of which is pre-mounted on the distal end of the delivery device, and the others are mounted on a plurality of holders 500 on a card 502), and a suture element 346 for joining the plurality of 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 has an endoscope channel liner 480, which acts as a flexible tubular protective barrier between the working channel of the endoscope and the anchor delivery system, and in particular acts 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, held in a single-use package suitable for single use. The packaged kit is preferably provided pre-sterilized for use.

[0041] Referring next to Figures 9A and 9B, the delivery system 310 has a proximal operating handle 510 having a stationary shaft 512 and a longitudinally displaceable spool 514. The shaft 512 has a thumb ring 516 and an axial slot 518. A worm gear 520 is rotatably mounted in the axial slot 518. The spool 514 forms a finger grip 515 and a drive bar 521 extending into the slot 518. The drive bar 521 forms an inner bore 522 having a helical shape. The spool 514 is connected in close contact with the worm gear 520. Displacing the spool 514 across the worm gear 520 causes the worm gear 520 to rotate around its longitudinal axis A. A torque-transmitting shaft 522 is fixed to the distal end of the worm gear 520. As the worm gear rotates, the torque-transmitting shaft 522 rotates by the same degree of rotation.

[0042] Next, referring to Figures 9A to 10, a longitudinally rigid sheath 524, such as a flattened coil, is provided across a torque-transmitting shaft 522. The proximal end 525 of the sheath 524 is connected to a ferrule 526, and the distal end 528 of the sheath has a substantially flat end 530. The ferrule 526 is screwed at a threaded portion 529 on the distal end of the shaft portion 512 of the operating handle 510. As the ferrule 526 rotates, it is displaced longitudinally as it moves forward or backward through the threaded portion, and as a result, the flat end 530 of the sheath 524 is displaced longitudinally relative to the suture anchor engagement post 350 fixed to the distal end of the torque-transmitting shaft 522. This allows the suture anchor 542 to be controlled and disengaged from the engagement post 350, as described below.

[0043] As an alternative to deployment via ferrule and, consequently, sheath thread displacement, a spring release can be provided that, during operation, results in an automatic longitudinal displacement of the sheath by a predetermined distance sufficient to deploy the suture anchor from the engaging post 350. The spring release is preferably activated by a push button located on the proximal handle.

[0044] Referring to Figure 10, the 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 portion 538 between the first and second portions that functions as a stopper for the suture anchor, a third portion 540 that forms a plurality of opposing recesses 542 that function as keyways for receiving a rotating key within the suture anchor for applying rotational force, and a bulbous distal fourth portion 544 that prevents undesirable deployment until the disengagement of the suture anchor is activated.

[0045] Referring to Figures 11-17, in one embodiment, the suture anchor 342 has a laser-cut tube 550 and an eyelet ring 552. The laser-cut tube 550 forms a distally open helical coil 554 having a sharp distal end 556 and a proximal post receiver 558. In one embodiment, the distally open helical coil 554 has a length of approximately 2.5 mm. As shown in Figures 11 and 12, the proximal post receiver 558 is dimensioned to receive across the second portion 534, third portion 536 and fourth portion 538 of the post 350, but to stop at a shoulder 538 formed between the first and second portions. The receiver 558 has a pair of recesses 560 suitable for receiving the bulbous distal fourth portion 544 of the post, and a pair of radially inwardly extending first tabs 562 that form anti-rotation keys extending into several opposing recesses 542 on the post. The receiver also has two pairs of radially outward biased second tabs 564, each pair facing opposite each other in the diametrical direction, forming a circumferential channel 566. The eyelet ring 552 has a circular first opening 568 and a second opening 570 located outside the first opening. The circular first opening 568 has substantially the same diameter as the outer diameter of the tube 550. During the assembly of the suture anchor 542, the proximal end 572 of the tube is pushed through the first opening 568 until the proximal end of the outwardly biased second tab 564 is displaced inward, allowing the ring 552 to seat in the channel 566, and then the proximal tab is released and returned outward, fixing the ring 552 in its longitudinal position on the tube (i.e., between the two pairs of tabs 564). While fixed on the tube 550, the ring 552 can rotate around the tube 550. The second opening 570 receives the suture 546 through it. Thus, the tube 550 can be rotated by the rotation of the unfolding post 350, but the eyelet ring 552 and the suture 346 are independent of the above rotation and do not follow the above rotation.

[0046] As shown in Figure 15, the laser-cut tube 550 can be formed with a variety of features. According to one embodiment, the winding of the coil 554 has a flat cross-section corresponding to the wall of the tube 550, however, other cross-sectional shapes, including round and D-shaped, can be formed during the manufacturing process. Furthermore, the coil can be formed with a constant pitch or a variable pitch. In addition, one or both surfaces of the coil can be formed with a laser texture or texture by other means to facilitate insertion and / or tissue retention. As an example, the laser-cut coil 554a can be formed to have a plurality of integrated barbs 576, as shown in Figure 18.

[0047] One embodiment of the suture anchor consists of only two elements: a tube and an eyelet ring. A further embodiment is one in which assembly is simply a matter of pressing the eyelet ring onto the tube. That is, no welding, brazing, bonding, or other joining is required between the two components in order to hold them together. Another embodiment is one in which the eyelet ring is rotatable on the tube but is held longitudinally on the tube. Yet another embodiment is one in which all features for holding the eyelet ring on the tube, and for holding the assembled suture anchor to the deployment post, are formed by laser cutting the appropriate structure into the tube.

[0048] It is recognized that various structures of the engagement post and laser-cut tube can be reversed, namely, the engagement post can be formed from the 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] Referring to Figures 9A, 9B, and 11, the movement of the spool portion 514 along the worm gear 520 from one end to the other is suitable for causing sufficient rotation of the helical coil 554 to fully embed the coil in the tissue. That is, if the coil 554 extends through a rotation of 1140°, the movement of the spool portion 514 along the worm gear through the length of the slot 518 causes the flexible shaft 522 to rotate 1140°. If the procedure requires an anchor 542 with a coil 554 having a smaller angular rotation for full embedding, then a spacer 580 (Figure 9A) can be inserted at or on one end of the spool portion, and the spacer 580 can function to stop and limit the movement of the spool portion relative to the worm gear in order to limit the effective rotation caused by the movement of the spool portion.

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

[0051] Referring to Figures 8 and 19-21, in all embodiments, a removable mounting section 504 can be provided to temporarily fix the delivery device 310 to the endoscope 140 and to position additional suture anchors 342 (suture anchors not mounted on the deployment post 350 in the delivered configuration of the approach system) in a position convenient for the surgeon. The mounting section 504 comprises a support 600 suitable for being received across the endoscope adjacent to the endoscope handle 602, a bracket 604 having several opposing retainers 606, and an arm 608 for displacing the bracket from the support. Furthermore, an elastic band 610 is provided, which is attached to several side buttons 612 on the mounting section 504 (Figure 8). The suture anchors 342 are held in several disposable plugs 614 and mounted in a space 616 on a card 618. The card 618 is mounted in a bracket 604 held by retainers 606 (Figure 21). In the configuration with the card attached, some anchors 342 have sutures 346 pre-threaded through them. The plugs 614 can be individually released from the space 616 within the card 618 and manually operated to load each sutured anchor onto the delivery member post 350 after the delivery of the previous anchor.

[0052] Here, in the method of use, the components of the access system are provided together as a kit in a sterile package, as generally shown in Figure 8. The kit is opened, and the channel liner 480 is removed and advanced within the working channel of the endoscope. (It is recognized that the deployment of one or more suture anchors via the delivery device is performed under endoscope visualization.) The delivery device 310 is pre-loaded with a suture anchor 342 at its distal end, and the suture thread 346 is securely attached to the eyelet 552. As described above, it is preferable that the suture thread 346 extends posteriorly along the delivery system 310 and is pre-threaded through the eyelets of other suture anchors.

[0053] The distal end of the delivery device 310 is advanced toward the target tissue location by passing through the channel liner 480 in the working channel, extending the tip of the endoscope. Once the tissue anchor is in the target position, 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 with the target tissue. The speed of rotation and engagement is controlled by the speed of the parallel movement of the spool portion 514 along the shaft portion 512 of the handle 510. If the engaged position is not ideal, the direction of the spool portion 514 can be reversed, causing the suture anchor 342 to rotate in the opposite direction, thereby disengaging the anchor from the tissue. The suture anchor 342 can then be repositioned as appropriate. After successful engagement of the tissue by the first suture anchor 342, the ferrule 526 is advanced toward the handle 510. As described above, in one embodiment, the advancement is performed by helically rotating the ferrule 526 relative to the shaft 512. As the ferrule 526 advances, the distal end 530 of the flattened coil 524 advances across 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 it from the deployment post 350, thereby separating the suture anchor 342 from the delivery system 310.

[0054] Next, the delivery system 310 is retracted through the channel liner 480. The plug 614 with the second suture anchor 342 is removed from the card 618 and advanced along the suture 346 as needed, and pushed in to engage with the deployment post 350. Next, the plug 614 is removed from the suture anchor 342 and discarded. The delivery system 310 is then retracted downward through the channel liner 480 to deploy the second suture anchor 342. This process is repeated as needed for subsequent suture anchors until all target tissue locations accept the suture anchors. The delivery system is then finally removed from the channel liner 480, and the channel liner 480 can also be removed from the working channel of the endoscope.

[0055] Next, the tissue access system 302 is preferably used in conjunction with a scinch system suitable for applying tension to the suture, thereby drawing the embedded suture anchors into a tightened configuration, and then holding the suture in the tightened configuration. Since the scinch system has numerous other uses, it may be packaged with the access system kit or packaged separately. Exemplary suture scinch systems include those described in the previously incorporated shared U.S. Patent Nos. 8,540,735 and 9,788,831, or the shared U.S. Patent Application Publication No. 2017 / 0086818.

[0056] Thus, following the next step, the scintigraphy system is threaded through the suture and delivered through an operating channel adjacent to the suture anchor, which is the last to be delivered. Under endoscopic visualization, tension is applied to the suture, pulling the tissue anchors toward each other to achieve the intended tissue manipulation. In most cases, the intended tissue manipulation involves a step to bring the tissue anchors closer together so that the tissue portions associated with the anchors come into direct contact with each other, thereby aiding the healing process. The scintigraphy device is activated, and the scintigraphy is pressed onto the suture to cut it, thereby ensuring the tissue manipulation.

[0057] All of the above allows for various tissue manipulations. In one embodiment, several anchors can be positioned around the gastric defect 700, as shown in Figures 22 and 23. For example, the gastric defect 700 may be a submucosal resection site or a tissue perforation. The gastric defect 700 is closed by positioning four suture anchors so that the suture extends in a zigzag configuration around the defect. The suture is then tightened and secured with a cinch 702, as shown in Figure 24, bringing the surrounding tissues closer together. In another example shown in Figures 25-27, the defect 710 can be closed by positioning several anchors around the defect and tightening the suture in a “purse string” manner. In further examples shown in Figures 28 and 29, the suture anchors can be positioned together with one or more suture anchors preferably located outside the defect, either partially inside the defect (Figure 28) or completely inside the defect (Figure 29). Furthermore, as shown in Figure 29, the suture path 720 can extend transversely in two directions, through and / or across the defect.

[0058] In yet another use, suture anchors can be used to secure implants within the gastrointestinal tract. One such method, shown in Figure 30, involves embedding several suture anchors 342 into the soft tissue on both sides of a gastrointestinal tube 800, and then securing the tube by applying tension to the sutures 346 and securing them with a scintillator 802. In another method, shown in Figure 31, the suture anchors 342 are positioned through a coarse mesh of struts within a stent 810, tension is applied to the sutures through the anchors, and the stent is secured to the tissue by securing the tensioned sutures with a scintillator. In yet another method, as shown in Figure 32, a gastric balloon 820 can be secured to the soft tissue within the stomach 822 using one or more suture anchors 342. Referring to Figures 33 and 34, the suture anchors 342 can also be used individually or in arrangement, but without suturing, to endoscopically mark tissue within the gastrointestinal tract. For example, the location for further or subsequent investigation in the stomach 832 can be marked with suture anchors 342a, 342b. The location of the anchors can then be identified by fluoroscopy, palpation, or subsequent endoscopy.

[0059] This specification describes and illustrates an endoscopic tissue access system for deploying one or more suture anchors, embodiments of suture anchors, and embodiments of a method for deploying one or more anchors, fixing tissue, and reconstructing tissue. Although specific embodiments of the present invention are described, the present invention is not intended to be limited to specific embodiments, as the scope of the present invention is as broad as that of the art and the specification is intended to be read as similarly. It is particularly intended that the aspects of various embodiments can be combined with one another. For example, multiple barbs on a coil of one of several anchors can be provided for any of several anchors. Furthermore, the term “suture” is intended to encompass any suitable tether that can connect to and tighten multiple anchors together, and is not intended to be limiting, as it may include materials that are not typically considered “suture” materials. Accordingly, it will be recognized by those skilled in the art that further modifications to the provided invention can be made without departing from the technical scope of the claims. Furthermore, this invention also includes the following inventions. A first aspect of the present invention is: In an endoscopic deployment system for placing suture anchors in mammalian tissues, The aforementioned endoscope deployment system, An elongated, flexible delivery member having a proximal region, an intermediate region, and a distal region, and a proximal end and a distal end, An elongated shaft member having a proximal end and a distal end, A handle connected to the proximal end of the shaft member, the handle rotating the distal end of the shaft member by the rotation of the proximal end of the shaft member, A coupling assembly having an engaging post, which is fixedly connected to the distal region of the delivery member, A suture anchor having a proximal end and a distal end, A tubular receiver having a central longitudinal axis, The coil member located at the distal end, The tubular receiver is equipped with a rotatable suture eyelet, The delivery member has a first operable configuration and a second operable configuration, In the first operable configuration, the suture anchor is releasably connected to the coupling assembly, thereby connecting the engaging post to the tubular receiver, and the rotation of the distal end of the shaft member engages the coil member of the suture anchor with the tissue when the suture anchor is in contact with the tissue. In the second operable configuration, the suture anchor is detached from the suture anchor, and the delivery member is operable between the first operable configuration and the second operable configuration, in which case the endoscope deployment system is configured. A second aspect of the present invention is: The endoscope deployment system in the first embodiment is operable to rotate the proximal end of the shaft member so as to cause rotation of the distal end of the shaft member. A third aspect of the present invention is: The aforementioned handle, i) A stationary member forming a longitudinal slot, ii) A movable member that can be displaced longitudinally across the stationary member, and having a drive unit located within the slot, iii) A worm gear rotatably mounted within the slot, the worm gear having a proximal end and a distal end, the drive unit of the movable member having a bore having an opening that closely accommodates the worm gear, and the worm gear is rotated when the movable member is displaced across the stationary member, thereby rotating the shaft member, in a first embodiment of an endoscope deployment system. A fourth aspect of the present invention is: The endoscope deployment system in the first embodiment further comprises a sheath having a proximal end and a distal end, the sheath extending over the shaft 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 across the shaft member to disengage the suture anchor from the engagement post. A fifth aspect of the present invention is: The endoscope deployment system further comprises a suture anchor release surface located proximal to the suture anchor, and the handle is operable to move distally so as to bring the suture anchor release surface into contact with the proximal surface of the suture anchor, thereby disengaging the suture anchor from the engagement post, in a first embodiment of the endoscope deployment system. A sixth aspect of the present invention is: The handle is operated to move the suture anchor release surface by operating a spring release or by spirally advancing the coupler to which the suture anchor release surface is connected, in a fifth embodiment of the endoscope deployment system. A seventh aspect of the present invention is: The first embodiment of the endoscope deployment system is such that the flexible delivery member is flexible enough to be positioned along a winding path. An eighth aspect of the present invention is: The first embodiment of the endoscopic deployment system is characterized in that the flexible delivery member and the suture anchor in the first operable configuration are arranged within the lumen of an elongated sheath having a proximal end and a distal end. A ninth aspect of the present invention is: The endoscopic deployment system in the eighth embodiment is characterized in that the elongated sheath is separated from the proximal handle. A tenth aspect of the present invention is: This is an endoscope deployment system in a first embodiment, wherein the distal region of the delivery member has a first rotation key, the suture anchor has a second rotation key, and the first rotation key and the second rotation key rotate in a manner that interferes with each other. An eleventh aspect of the present invention is: The endoscopic deployment system in a first embodiment is characterized in that the engaging post has at least one recess, the suture anchor has at least one tab, and when the engaging post is connected to the tubular receiver, the at least one tab and the at least one recess rotationally interfere with each other such that the axial rotation of the engaging post causes the suture anchor to rotate. A twelfth aspect of the present invention is: The first embodiment of the endoscopic deployment system is a system in which the engaging post has one of a recess and a tab, the suture anchor has the other of a recess and a tab, and when the engaging post is connected to the tubular receiver, the tab and the recess rotationally interfere with each other such that the axial rotation of the engaging post causes the suture anchor to rotate. A thirteenth aspect of the present invention is: The endoscope deployment system in the first embodiment comprises a tubular member and a suture eyelet, wherein the tubular member forms both the tubular receiver and the coil member. A fourteenth aspect of the present invention is: This is an endoscope deployment system in a first embodiment in which the coil member of the suture anchor is tapered. A fifteenth aspect of the present invention is: This is an endoscope deployment system in a first embodiment, wherein the coil member of the suture anchor has a variable pitch. A sixteenth aspect of the present invention is: In the method of deploying suture anchors into tissue, The aforementioned method, a) An endoscope deployment system having a proximal end and a distal end, wherein the endoscope deployment system is i) Handle and ii) An elongated shaft member having a proximal end and a distal end and defining a longitudinal axis, wherein the proximal end is connected to the handle, iii) Providing an endoscopic deployment system comprising: a suture anchor having a coil distal end having a tissue-perforating distal end, which is detachably connected to the distal end of the shaft member, wherein rotation of the shaft member causes rotation of the coil, and when the distal end of the coil is in contact with the tissue, the distal end of the coil perforates the tissue and engages with the tissue; b) The step of positioning the distal end of the endoscope deployment system adjacent to the first tissue location, c) The step of rotating the coil around its longitudinal axis to advance the coil and engage it with the first tissue position, d) A method for deploying a suture anchor into tissue, comprising the steps of retracting the elongated shaft member to separate the suture anchor from the shaft member, thereby depositing the suture anchor at the first tissue location. A 17th aspect of the present invention is: The aforementioned method, The steps include: rotating the coil around its longitudinal axis, advancing the coil to engage with the first tissue position, and before retracting the elongated shaft member, separating the suture anchor from the elongated shaft member, thereby depositing the suture anchor at the first tissue position; The steps include: rotating the coil in opposite directions around its longitudinal axis to withdraw the coil from engagement with the first tissue position; The steps include: repositioning the distal end of the endoscope deployment system adjacent to the second tissue location; A method in a sixteenth embodiment, comprising the steps of rotating the coil around its longitudinal axis to advance the coil and engage it with the second tissue position. An eighteenth aspect of the present invention is: The aforementioned endoscope deployment system has multiple suture anchors, The aforementioned method, For each suture anchor to be deployed, The steps include: positioning the distal end of the endoscope deployment system adjacent to each tissue location, and rotating the coil around its longitudinal axis to engage with each tissue location; The method in the 16th embodiment further comprises the step of retracting the shaft member to separate the suture anchor from the shaft member, thereby depositing the suture anchor at each tissue location. A 19th aspect of the present invention is: The aforementioned multiple suture anchors are connected to a common suture thread, A method in an 18th embodiment, comprising applying tension to the sutures between the multiple deposited suture anchors to reconstruct the relative first tissue position and the respective tissue positions, and then maintaining the tension applied to the sutures. A 20th aspect of the present invention is: In endoscopic suture anchors for tissue access, The endoscopic suture anchor for tissue access is, A coil having a proximal end and a distal end, A distal tip positioned at the distal end, which is suitable for perforating tissue, A coupling assembly positioned at the proximal end of the coil, A suture eyelet for endoscopic suturing anchor for tissue access, comprising a suture eyelet connected to the coupling assembly, wherein the suture eyelet is rotatable relative to the coil and independent of the coil. A 21st aspect of the present invention is: The coil is an endoscopic suture anchor in a 20th embodiment, wherein the coil has a longitudinal length and a uniform pitch over the longitudinal length. A 22nd aspect of the present invention is: The coil is an endoscopic suture anchor in a 20th embodiment, having a longitudinal length and having at least two different pitches along the longitudinal length. A 23rd aspect of the present invention is: The coil has a longitudinal length and a uniform diameter along the longitudinal length, in a 20th embodiment, which is an endoscopic suture anchor. A 24th aspect of the present invention is: The coil is an endoscopic suture anchor in a 20th embodiment, having a longitudinal length and a tapered diameter. A 25th aspect of the present invention is: The coupling assembly is integrally formed with the coil, and is an endoscopic suture anchor in a 20th embodiment. A 26th aspect of the present invention is: The coupling assembly is an endoscopic suture anchor in a 20th embodiment, having a rotary key such that the coil rotates as a result when the rotary key is rotated. A 27th aspect of the present invention is: The coil is a bioactive material, and this is a 20th embodiment of an endoscopic suture anchor. A 28th aspect of the present invention is: The coil is a hydrogel-containing endoscopic suture anchor in a 20th embodiment. A 29th aspect of the present invention is: The coil is a bioabsorbable material, and this is a 20th embodiment of an endoscopic suture anchor. A 30th aspect of the present invention is: In endoscopic suture anchors for tissue access, The endoscopic suture anchor for tissue access is, A tubular member, wherein the tubular member is (i) A receiver for connecting to the deployment device, (ii) A coil having a distal tip suitable for perforating tissue, (iii) An endoscopic suture anchor for tissue access, comprising a tubular member that forms a suture eyelet ring, which is rotatable relative to the coil and independent of the coil, arranged around the tubular member. A 31st aspect of the present invention is: The tubular member is an endoscopic suture anchor in a 30th embodiment, which is laser-cut to form a tab and an open recess for engaging with the structure of the deployment device. A 32nd aspect of the present invention is: An endoscopic suture anchor in a 31st embodiment, wherein at least one tab extends radially outward and at least one tab extends radially inward. A 33rd aspect of the present invention is: This is a 30th embodiment of an endoscopic suture anchor, wherein the coil is formed as the wall thickness of the tubular member. A 34th aspect of the present invention is: The coil has a plurality of barbs, in a 30th embodiment, which is an endoscopic suture anchor. A 35th aspect of the present invention is: In methods of approaching an organization, The aforementioned method, a) First, the step of engaging a first tissue anchor with the tissue at a first location that is at least partially inside the wound, b) Next, a step of engaging a second tissue anchor with tissue at a second position, wherein the first tissue anchor and the second tissue anchor are connected by suture, c) Applying tension to the suture between the first tissue anchor and the second tissue anchor to bring the tissue between the first tissue anchor and the second tissue anchor closer together; d) a method comprising the step of fixing the tensioned suture to maintain the proximity. A 36th aspect of the present invention is: The method in the 35th embodiment is characterized in that the first tissue anchor has a tissue engagement coil, and the first engagement includes a step of rotationally engaging the first tissue anchor within the tissue. A 37th aspect of the present invention is: The method in the 35th embodiment is such that the second position is located outside the wound. A 38th aspect of the present invention is: The method in the 35th embodiment is such that the second position is at least partially inside the wound. A 39th aspect of the present invention is: The method further comprises the step of engaging at least a third tissue anchor at at least a third position, The step of applying tension is a method in the 37th embodiment, comprising the step of applying tension to the suture between the first tissue anchor, the second tissue anchor, and at least the third tissue anchor. A 40th aspect of the present invention is: In methods of approaching an organization, The aforementioned method, a) A first rotational engagement step, in which a first coil anchor is rotatably engaged with the tissue at a first position relative to the wound, b) A second rotational engagement step, in which the second coil anchor is rotatably engaged with the tissue at a second position relative to the wound, c) A third rotational engagement step, wherein at least a third coil anchor is rotatably engaged with the tissue at at least a third position relative to the wound, the first coil anchor, the second coil anchor and at least the third coil anchor are connected by sutures, d) Applying tension to the suture between the first coil anchor, the second coil anchor, and at least the third coil anchor, bringing the tissue between the first coil anchor, the second coil anchor, and at least the third coil anchor closer together; e) a method comprising the step of fixing the tensioned suture to maintain the proximity. A forty-first aspect of the present invention is: The fortyth embodiment of the method is characterized in that, prior to the step of applying tension, the suture extends in a zigzag path across the wound. A 42nd aspect of the present invention is: The method in the 40th embodiment is such that, prior to the step of applying tension, the suture extends in a path around the wound. A forty-third aspect of the present invention is: The fortyth embodiment of the method is characterized in that, prior to the step of applying tension, the suture extends in a cross path that traverses the wound. A 44th aspect of the present invention is: The fortyth embodiment of the method is characterized in that the suture extends through or around an implant positioned in relation to the tissue. A forty-fifth aspect of the present invention is, The method in the 40th embodiment is such that at least one of the first coil anchor, the second coil anchor, and the third coil anchor extends into the tissue through the implant. A forty-sixth aspect of the present invention is: In the method of deploying suture anchors into tissue, The aforementioned method, a) An endoscope deployment system having a proximal end and a distal end, The aforementioned endoscope deployment system, i) Handle and ii) An elongated shaft member having a proximal end and a distal end and defining a longitudinal axis, wherein the proximal end is connected to the handle and the distal end has an engagement post, iii) A sheath having a proximal end and a distal end connected to the handle, the sheath extending over the shaft member, iv) A suture anchor having a distal end of a coil with a tissue-perforating tip, which is removably connected to the engagement post at the distal end of the shaft member, wherein rotation of the shaft member causes rotation of the coil, and the distal end of the coil is suitable for perforating the tissue and engaging with the tissue when the distal end of the coil is rotated relative to the tissue, b) The step of positioning the distal end of the deployment system adjacent to the first tissue location, c) The step of rotating the coil around its longitudinal axis to advance the coil and engage it with the first tissue position, d) a method comprising the steps of advancing the sheath relative to the elongated shaft member, pressing the distal end of the sheath against the suture anchor, thereby separating the suture anchor from the engagement post, thereby depositing the suture anchor at the first tissue location. A forty-seventh aspect of the present invention is: The sheath is rigid in the longitudinal direction, according to the 46th embodiment of the method. A forty-eighth aspect of the present invention is: The deployment system is a method in a 46th embodiment, wherein the deployment system has a connecting member between the proximal end of the sheath and the handle, the connecting member being able to advance spirally relative to the handle. A 49th aspect of the present invention is: In a kit for tissue access through the operating channel of an endoscope, The aforementioned kit is a) Endoscope deployment system, wherein the endoscope deployment system is i) Handle and ii) An endoscope deployment system comprising an elongated shaft member having a proximal end and a distal end and defining a longitudinal axis, wherein the proximal end is connected to the handle, and the distal end has an engagement post, and the elongated shaft member is sized for insertion through the operating channel of the endoscope, b) A plurality of suture anchors, each suture anchor having a distal end of a coil having a distal tip for perforating tissue, which is detachably connectable to the engagement post at the distal end of the shaft member, and the rotation of the shaft member causes the rotation of the coil, and when the distal end of the coil is rotated relative to the tissue, the distal end of the coil is suitable for perforating and engaging with the tissue, c) A kit for tissue access through the operating channel of an endoscope, comprising sutures that extend in advance through the plurality of anchors. A 50th aspect of the present invention is: A kit in a 48th embodiment, wherein one of the suture anchors is mounted on the engagement post, and at least one of the suture anchors is provided in the device for separate handling and subsequent mounting to the engagement post. A 51st aspect of the present invention is: A kit in a 50th embodiment, wherein multiple suture anchors are held in their respective holders, and each of the holders is mounted on a card. A 52nd aspect of the present invention is: A kit in a 51st embodiment, comprising an endoscope bracket suitable for connecting the deployment system to the endoscope, further comprising an endoscope bracket for supporting the card. A 53rd aspect of the present invention is: A kit in a 49th embodiment further comprising a channel liner suitable for extending through the operating channel of the endoscope before insertion of the deployment system and suitable for forming a barrier between the deployment system and the operating channel when the deployment system is subsequently inserted into the operating channel.

Claims

1. An endoscopic deployment system for positioning suture anchors in a mammalian body, wherein the endoscopic deployment system is An elongated shaft member having a proximal end and a distal end, An engagement post extending distally from the distal end of the elongated shaft member, A suture anchor having a proximal end and a distal end, an engagement receiving portion defined at the proximal end, and a coil member located at the distal end, A sheath having a proximal end and a distal end, the sheath extending over the shaft member such that the distal end of the sheath is located proximal to the suture anchor, In the first operable configuration, the engaging post is connected to the engaging receiving portion, and the rotation of the distal end of the shaft member causes the suture anchor to rotate, thereby engaging the coil member of the suture anchor with the tissue when the suture anchor is in contact with the tissue. An endoscope deployment system in a second operable configuration, wherein the sheath is advanced distally, covering the axial member, to disengage the suture anchor from the engagement post.

2. The endoscope deployment system according to claim 1, further comprising a handle, wherein the sheath is separated from the handle.

3. The endoscope deployment system according to claim 2, wherein the handle is operable to rotate the proximal end of the shaft member so as to cause rotation of the distal end of the shaft member.

4. The suture anchor release surface is further located proximal to the aforementioned suture anchor, The endoscopic deployment system according to claim 2 or 3, wherein the handle is operable to move distally so as to bring the suture anchor release surface into contact with the proximal surface of the suture anchor, thereby disengaging the suture anchor from the engagement post.

5. The endoscope deployment system according to claim 4, wherein the handle is operated to move the suture anchor release surface by operating a spring release or by spirally advancing the coupler to which the suture anchor release surface is connected.

6. The endoscopic deployment system according to any one of claims 1 to 5, further comprising a flexible delivery member that is flexible enough to extend through a winding path within the patient's body.

7. The endoscopic deployment system according to any one of claims 1 to 5, further comprising an elongated delivery member having a proximal region, an intermediate region, and a distal region, wherein the distal region of the delivery member includes a first rotation key, the suture anchor includes a second rotation key, and the first rotation key and the second rotation key rotationally interfere with each other.

8. The endoscope deployment system according to claim 7, wherein the engagement post is provided in the distal region of the elongated delivery member.

9. The aforementioned suture anchor further includes a suture eyelet, The endoscope deployment system according to any one of claims 1 to 8, wherein the suture eyelet is rotatable with respect to the engagement receiving portion such that the axial rotation of the suture anchor does not cause the axial rotation of the suture eyelet.

10. The endoscope deployment system according to any one of claims 1 to 9, wherein the engagement post includes one of a recess and a tab, and the suture anchor includes the other of the recess and the tab, and when the engagement post is connected to the engagement receiving portion of the suture anchor, the tab and the recess rotationally interfere to cause rotation of the suture anchor by the axial rotation of the engagement post.

11. An elongated, flexible delivery member having a proximal region, an intermediate region, and a distal region, and a proximal end and a distal end, The endoscope deployment system according to any one of claims 1 to 10, further comprising a coupling assembly fixedly connected to the distal region of the elongated flexible delivery member, the coupling assembly including the engaging post.

12. The engagement post has at least one recess, The suture anchor has at least one tab, The endoscopic deployment system according to claim 1 or 10, wherein when the engaging post is connected to the engaging receiving portion, the at least one tab and the at least one recess rotationally interfere with each other, thereby causing the axial rotation of the engaging post to result in the rotation of the suture anchor, and when the suture anchor is in contact with tissue, the rotation of the distal end of the axial member causes the coil member of the suture anchor to engage with the tissue.

13. The endoscope deployment system according to any one of claims 1 to 12, wherein the suture anchor comprises a tubular member that defines both the engagement receiving portion and the coil member.

14. The endoscopic deployment system according to any one of claims 1 to 12, wherein the coil member of the suture anchor is tapered.

15. The endoscopic deployment system according to any one of claims 1 to 12, wherein the coil member of the suture anchor has a variable pitch.

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