Tightening system and tightening device

Abstract

The method includes providing a cinch having a suture capture portion configured to capture the suture, a cinch lock coupled to the suture capture portion, and a cinch anchor having an internal lumen. The suture capture portion extends outward from the internal lumen to capture the suture. The suture is captured by the suture capture portion. The suture capture portion is retracted into the internal lumen of the cinch anchor. The suture is cinched between the cinch lock and the cinch anchor.

Description

[Technical Field]

[0001] STATEMENT REGARDING FEDERALLY FUNDED RESEARCH This invention was made with government support under Award #1912944 from the National Science Foundation (NSF) SBIR Phase I. The U.S. Government has certain rights in this invention. Priority This patent application claims priority to U.S. Provisional Patent Application No. 63 / 104,585, filed October 23, 2020, entitled "ENDOSCOPIC SUTURE CINCH AND METHOD OF APPLYING," with Azadeh Khanicheh and Amos G. Cruz as inventors, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Exemplary embodiments of the present invention relate generally to endoscopic devices, and more particularly, various embodiments of the present invention relate to a suture cinch delivered through a working channel of an endoscope. [Background technology]

[0003] Suture cinches are an alternative method for tying knots to secure and anchor sutures for wound closure and tissue approximation. Cinching devices can be utilized for both interrupted and continuous stitching. Such cinching devices generally affix the suture by compression between two concentric cylindrical components. Currently available flexible endoscopic cinching devices load the suture into the cinch outside the patient's body. The free end of the suture (this is the end of the suture that is not attached to the needle) must be loaded into the cinching device outside the working channel of the endoscope. Such devices often utilize a suture threader to thread the suture into the cinch, allowing the cinch to be advanced through the working channel of the endoscope.

[0004] Endoscopic snares are typically used to remove polyps, adenomas, or foreign bodies from inside the gastrointestinal tract through the working channel of an endoscope, or endoscopic hooks are currently used for endoscopic submucosal dissection. Summary of the Invention [Means for solving the problem]

[0005] According to one embodiment of the present invention, a method for cinching a suture includes providing a cinch having a suture capture portion configured to capture the suture, a cinch lock coupled to the suture capture portion, and a cinch anchor having an internal lumen. The suture capture portion extends outward from the internal lumen to capture the suture. The suture is captured by the suture capture portion. The suture capture portion is retracted into the internal lumen of the cinch anchor. The suture is cinched between the cinch lock and the cinch anchor.

[0006] The method can position the cinch within a working channel of an endoscope. In various embodiments, the suture trap extends out of the working channel of the endoscope. The method can deploy the cinch anchor within the patient by pushing the handle to overcome a threshold deployment force. The method can also disengage the suture trap from the cinch lock by pulling the handle to overcome a threshold disengagement force. The cinch can be coupled to a delivery shaft of a handheld cinching device. The delivery shaft can be positioned within an accessory port of the endoscope. The accessory port can lead to a working channel inside the insertion tube. The suture trap can be rotatable (e.g., using the handle) relative to the lumen and / or the insertion tube.

[0007] The suture capture portion may include a snare. In various embodiments, the suture capture portion may be flexible. In various embodiments, the suture capture portion may expand after or as it is extended from the delivery housing and / or anchor. In various embodiments, the suture capture portion defines an opening that is larger than the diameter of the lumen. This advantageously allows the snare / hook to easily capture the suture. Due to its flexibility, the snare / hook (capturing portion) may be retracted into the delivery catheter and anchor housing. To that end, the suture capture portion may be formed from a wire. The wire may be formed from stainless steel, nitinol, nylon, braided polyester, polypropylene, and / or silk. The suture capture portion may have a thickness of between about 0.005 inches and about 0.025 inches.

[0008] The method may stitch the suture within the patient prior to capturing the suture. The method may also capture the suture inside the patient's body. The suture may be cinched by an interference fit between the cinch anchor and the cinch lock.

[0009] According to another embodiment, a cinching system includes an endoscope having an insertion tube. The insertion tube has multiple channels. The system further includes a cinching device having a handle movably coupled to a flexible drive wire. The handle is configured to move the drive wire proximally or distally within a working channel of the endoscope. The cinching device includes a suture trap coupled to a distal end of the drive wire. Distal movement of the drive wire causes distal movement of the suture trap. The cinching device includes a cinch anchor having a lumen, the suture trap moving through the lumen. The cinching device also includes a cinch lock coupled to the suture trap. Distal movement of the suture trap causes distal movement of the cinch lock. Similarly, proximal movement of the suture trap causes proximal movement of the cinch lock. The inner diameter of the lumen is configured to achieve an interference fit with the cinch lock when the cinch lock enters the lumen.

[0010] In various embodiments, the cinch lock is releasably coupled to the suture capture portion. The cinch anchor may also be releasably coupled to the delivery housing. Among other things, the system can include a suture that can be stitched within the patient (e.g., before the suture capture portion captures the suture). The scintillator anchor can also have a fixation portion configured to couple the scintillator anchor with the delivery housing.

[0011] According to another embodiment, a cinching device includes a delivery housing configured to fit within a working channel (e.g., of an endoscope). A cinch anchor is coupled to the delivery housing. The cinch anchor has an inner lumen extending from a proximal end to a distal end. A suture trap is movably positioned within the lumen. The suture trap is configured to trap a suture. A cinch lock is coupled to the suture trap. The cinch lock is configured to achieve an interference fit with an inner diameter defined by the lumen when the cinch lock enters the lumen.

[0012] Among other things, the device may include a user-operated drive wire coupled with the suture capture portion. In various embodiments, the suture capture portion is flexible. The suture capture portion may include a snare and / or a wire.

[0013] Those skilled in the art will more fully appreciate the advantages of various embodiments of the present invention from the following detailed description, discussed in conjunction with the drawings summarized immediately below. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a diagram that schematically illustrates a patient lying on a table in a hospital environment, according to an exemplary embodiment of the present invention; [Figure 2A] 1 is a diagram illustrating a schematic diagram of an endoscope according to an exemplary embodiment of the present invention; [Figure 2B]FIG. 10 is a diagram that schematically illustrates a partially exposed view of an insertion tube, according to an exemplary embodiment. [Figure 2C] 1A and 1B are schematic diagrams illustrating a distal end of an insertion tube, in accordance with an exemplary embodiment of the present invention; [Figure 3] 1A and 1B are diagrams illustrating a cinching device according to an exemplary embodiment. [Figure 4] 10A-10C illustrate a process for cinching a suture, according to an exemplary embodiment of the present invention. [Figure 5A] 10A-10C are schematic diagrams illustrating a delivery shaft being advanced into an access port suture, according to an exemplary embodiment of the present invention. [Figure 5B] 10A-10C are schematic diagrams illustrating a delivery shaft being advanced into an access port suture, according to an exemplary embodiment of the present invention. [Figure 5C] 10A-10C are schematic diagrams illustrating a suture capture portion extending from a working channel, according to an exemplary embodiment of the present invention. [Figure 6A] 10A-10C are schematic diagrams illustrating a portion of a suture capture portion beginning to extend from a delivery housing. [Figure 6B] 1A-1C are schematic diagrams illustrating cross-sectional views of a cinch deployment system according to exemplary embodiments. [Figure 7A] 1A-1C are schematic diagrams illustrating a suture capture portion capturing a suture, according to an exemplary embodiment of the present invention; [Figure 7B] 10A-10C are schematic diagrams illustrating a captured suture being pulled into a working channel of an insertion tube, according to an exemplary embodiment. [Figure 7C] 10A-10C are schematic diagrams illustrating a captured suture being pulled into a working channel of an insertion tube, according to an exemplary embodiment. [Figure 7D] 10A-10C are schematic diagrams illustrating a captured suture being pulled into a working channel of an insertion tube, according to an exemplary embodiment. [Figure 7E] 10A-10C are schematic diagrams illustrating a captured suture being pulled into a working channel of an insertion tube, according to an exemplary embodiment. [Figure 8]Figure 8A is a schematic diagram illustrating a cross-sectional view of the distal end of a cinch deployment system according to an exemplary embodiment of the present invention, and Figure 8B is a schematic diagram illustrating the cross-sectional view of Figure 8A after the cinch lock has disengaged from the capture portion. [Figure 9] 9A and 9B are schematic diagrams illustrating perspective and cross-sectional views of a cinch anchor when a suture is held by a cinch lock, in accordance with an exemplary embodiment of the present invention; [Figure 10] Figures 10A, 10B, 10C, and 10D are schematic diagrams illustrating alternative configurations of a cinch according to an exemplary embodiment of the present invention. [Figure 11] 10B and 10C are schematic diagrams illustrating the process of capturing and locking a suture to an anchor using the cinch shown in FIG. 10A. [Figure 12] 10D and 10E are schematic diagrams illustrating the process of capturing and locking a suture to an anchor using the cinch shown in FIG. 10C. [Figure 13] 10C and 10D are schematic diagrams illustrating the process of capturing and locking a suture to an anchor using the cinch shown in FIG. 10B. [Figure 14] 10E and 10F are schematic diagrams illustrating the process of capturing and locking a suture to an anchor using the cinch shown in FIG. 10D. [Figure 15A] 10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 15B] 10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 15C] 10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 15D]10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 15E] 10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 15F] 10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 15G] 10A-10C are schematic diagrams illustrating alternative embodiments of suture capture portions, according to exemplary embodiments of the present invention; [Figure 16] 10A-10C are schematic diagrams illustrating rotation features of a cinching device according to an exemplary embodiment of the present invention. [Figure 17A] 10A-10C are diagrams illustrating schematically the operation of the handle of a cinching device, according to an exemplary embodiment of the present invention. [Figure 17B] 10A-10C are diagrams illustrating schematically the operation of the handle of a cinching device, according to an exemplary embodiment of the present invention. [Figure 17C] 10A-10C are diagrams illustrating schematically the operation of the handle of a cinching device, according to an exemplary embodiment of the present invention. [Figure 17D] 10A-10C are diagrams illustrating schematically the operation of the handle of a cinching device, according to an exemplary embodiment of the present invention. [Figure 17E] 10A-10C are diagrams illustrating schematically the operation of the handle of a cinching device, according to an exemplary embodiment of the present invention. [Figure 17F] 10A-10C are diagrams illustrating schematically the operation of the handle of a cinching device, according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0015] It should be noted that the foregoing figures, and the elements shown therein, are not necessarily drawn to consistent scale or to any scale. Unless the context suggests otherwise, like elements are designated by like numerals. The drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein.

[0016] In an exemplary embodiment, the endoscope has a flexible insertion tube including a working channel, and a cinch extends through the working channel to capture and cinch the suture. To that end, a cinching device is configured to deliver and deploy the cinch. The cinch deployment system includes a delivery housing coupled to a cinch anchor. The cinch anchor has a central lumen extending therethrough. A snare (or other hooked wire) extends out of the anchor's lumen and captures one or more free ends of the suture. When the snare is retracted into the anchor's lumen, a locking mechanism of the snare secures the suture to the anchor. The locking mechanism is then disengaged from the snare, and the anchor can be disengaged from the delivery device and deployed within the patient. Thus, the anchor and locking device can be used to cinch the suture, and the anchor can be left in the patient's body. Details of an exemplary embodiment are discussed below.

[0017] In currently available flexible endoscopic cinching devices known to the inventors, the suture is loaded into the cinch outside the patient's body. Such devices often utilize a suture threader to thread the suture through the cinch, allowing the cinch to advance through the working channel of the endoscope. In contrast, the exemplary embodiments capture the suture inside the patient's body at the treatment site (also called the tissue site or surgical site), advantageously allowing the physician more flexibility to use tools that do not have pre-loaded sutures.

[0018] FIG. 1 schematically illustrates a patient 12 lying on an operating or examination table in a hospital environment 10, in accordance with an exemplary embodiment of the present invention. Environment 10 may be, for example, within an endoscopy department of a hospital. The endoscopy department may include a physician 14 (e.g., a gastroenterologist or surgeon), a registered nurse 16, and various medical devices. For example, the medical devices may include an endoscope 18, a video display 20, and other equipment. Procedures performed within the endoscopy department may include gastrointestinal endoscopy (such as gastroscopy, colonoscopy, ERCP, and endoscopic ultrasound), bronchoscopy, cystoscopy, or other more specialized procedures.

[0019] 2A-2C schematically illustrate an endoscope 18 in accordance with an exemplary embodiment of the present invention. As known to those skilled in the art, a flexible endoscope 18 (e.g., a colonoscope, a gastroscope) is positioned within the body of a patient 12 through a natural orifice (e.g., the mouth, the anus) of the body. To that end, the endoscope 18 has a long, flexible insertion tube 22 that can conform to the body's natural pathways. Additionally, the endoscope 18 has multiple channels extending through the insertion tube 22. One of these channels is a working channel through which a tool can be advanced to the distal end 23 of the insertion tube 22.

[0020] The endoscope 18 may be contrasted with other devices, such as a laparoscope, which are not inserted into a natural orifice of the patient 12. Instead, the laparoscope is inserted into one of several access holes made in the patient 12 during a laparoscopic procedure. Typically, three access holes are made in a laparoscopic procedure: one for the rigid scope and two for ports for tools such as forceps, scissors, and sutures. The laparoscope has a short, rigid, inflexible insertion tube that is passed into the body through one of the access holes. Generally, laparoscopes do not have a working channel for advancing tools therethrough. In contrast, the insertion tube 22 of the endoscope 18 (e.g., colonoscope, gastroscope) is flexible and has a working channel for movement through a natural orifice in the body. Various embodiments may be used with various scopes, such as a laparoscope. However, a preferred embodiment uses a flexible insertion tube 22.

[0021] The endoscope 18 has a control section 26 to assist in guiding the insertion tube 22 through the patient's 12 body passages (e.g., the tortuous digestive tract). To that end, the endoscope 18 includes control dials 26 that allow control of the position and orientation of the insertion tube 22 (e.g., turning the distal end 23 up or down and left or right). Like many endoscopes, the endoscope 18 may have multiple imaging controls, such as an image freeze button and an image capture button. There may also be a control chromoendoscopy button that can change the color of the image in the display 20. The control section 24 may also include a suction button 28 and an air / water button 30. The endoscope 18 may be connected to a light source via a light guide 31, an air source via an air supply connector 32, a water source via a water supply connector 34, and a suction source via a suction connector 36. Thus, light, air, water, and / or suction may be delivered through the various channels described above, through umbilical cord 35, and to distal end 23 of insertion tube 22.

[0022] Water, air, suction, and other functions may be selectively applied at the distal end 23 through separate channels within the insertion tube 22. For example, a user may press a water button 30 to selectively spray water out of the distal end 23. To do so, water is drawn from an external water source through a water supply connector 34, passes through an umbilical cord 35 of the endoscope 18, and down the insertion tube 22 and out of the distal end 23. A similar process occurs for other functions, including light and suction. Each of these functions may have a dedicated channel within the endoscope 18.

[0023] FIG. 2B schematically illustrates a partially exposed view of the insertion tube 22 according to an exemplary embodiment. The insertion tube 22 has multiple channels 38-41 and wires 42-45 configured to provide various functions for the endoscope 18. For example, the insertion tube 22 includes a biopsy channel 38, an air channel 39, a water channel 40, and a water jet channel 41. The insertion tube 22 may also include, among other components, a light guide fiber 42, a wire 43 for adjustable stiffness, an angulation wire 44, and a CCD signal wire 45. These channels 38-41 and wires 42-45 are located within the housing of the insertion tube 22. The housing of the insertion tube 22 may include an outer polymer topcoat and a base layer 46. Beneath the polymer topcoat 46 may be a stainless steel wire mesh 47, along with an outer spiral metal band 48 and an inner spiral metal band 49.

[0024] 2C schematically illustrates the distal end 23 of the insertion tube 22 with a tool 50 extending out of the working channel 38, according to an exemplary embodiment of the present invention. The tool 50 may be positioned within the working channel 38 by passing through the accessory port 37 (shown in FIG. 2A). For example, FIG. 2C schematically illustrates a biopsy forceps 50 extending out of the working channel 38. Various embodiments use a cinching delivery device 54 to deliver the cinch through the working channel 38.

[0025] FIG. 3 schematically illustrates a cinching device 54 according to an exemplary embodiment. The cinching device 54 includes a handle slider 56 having an opening configured to receive the thumb of the practitioner 14. During use, the handle slider 56 slides along a handle frame 58. Movement of the handle slider 56 relative to the handle frame 58 moves a drive wire inside the delivery shaft 74 proximally or distally along the delivery shaft 74. In various embodiments, the drive wire 60 (also referred to as a pull wire 60) may be movable axially (e.g., along A1) within the delivery shaft 74. The drive wire 60 may be a long pull wire, such as a Bowden cable, inside a Bowden coil 65 for support. The Bowden coil (or spring guide) supports the pull wire 60. The pull wire 60 has a small diameter and generally does not have its own structural support. In various embodiments, the Bowden coil 65 provides structural support to the pull wire 60 (while passing through a working channel, etc.). Although A1 is shown as a straight axis, it should be understood that in various embodiments, the delivery shaft is configured to bend and / or twist in a manner similar to the insertion tube 22. Thus, movement along axis A1 may not be a linear axial movement.

[0026] The suture cinching device 54 includes a cinch deployment system 62 configured to deploy a cinch 64. The cinch 64 is configured to cinch one or more sutures passed through the patient 12 (e.g., within the patient's digestive tract). The cinch 64 includes a cinch lock 66, a suture capture portion 68 (e.g., a snare or wire), and a cinch anchor 70. The cinch anchor 70 is located within a delivery housing 72 at the distal end of a delivery shaft 74. In some embodiments, a first anchor fastener 83 is configured to couple the anchor 70 to the delivery housing 72. In some embodiments, the cinch anchor 70 includes an anchor fastener 83 (see FIG. 6A ) configured to couple the cinch anchor 70 to the delivery housing 72. To that end, the delivery housing 72 may include a mating anchor fastener therein. In some embodiments, the first anchor fastener 83 is configured to permanently couple to a second anchor fastener within the delivery housing 72. In some embodiments, the first anchor fastener 83 is configured to removably couple to a mating anchor fastener 113 within the delivery housing 72. For example, the first anchor fastener 83 may include a circular protrusion, and the second anchor fastener may be a cavity configured to receive the protrusion. The circular protrusion may fit into the cavity by deforming or by deforming a portion of the periphery of the cavity. Alternatively, the first anchor fastener 83 and / or the mating second anchor fastener may include snaps, hooks, welds, adhesives, screws, pins, or any combination thereof. However, in some embodiments, the scinch anchor 70 and the delivery housing 72 may be formed as a single component.

[0027] 4 illustrates a process 400 for cinching a suture, according to an exemplary embodiment of the present invention. It should be noted that this process has been simplified from a longer process that would typically be used to cinch a suture. Thus, the process 400 for cinching a suture would have many steps that one skilled in the art would use. Additionally, some of the steps may be performed in a different order than shown. Additionally, or alternatively, some of the steps may be performed simultaneously. Thus, one skilled in the art can modify the process 400 as needed.

[0028] Process 400 begins at step 402, in which physician 14 sutures a perforation inside patient 12. The process of suturing a perforation is known in the art and therefore will not be described in further detail. Generally, the process involves grasping tissue near the perforation (e.g., using tissue grasping tool 50), retracting the tissue, passing a needle coupled to a suture through the tissue, and repeating stitches as desired. Thus, in the above example, the suture has two ends: a first end coupled to the needle and a second, free end. Various embodiments may cinch the free end of the suture and / or the first end coupled to the needle together or separately. In some other embodiments, the suture is coupled to a needle that is part of a needle assembly (e.g., which passes through and grasps the tissue). Thus, the suture is considered to have a single free end and a second, tethered end. Thus, some embodiments may cinch only a single end of the suture. However, some other embodiments may cinch in multiple locations along the suture (e.g., both ends of one or more sutures). The suture may be formed of any material commonly used for surgical sutures, such as stainless steel, nitinol, nylon, braided polyester, polypropylene, and / or silk.

[0029] The process proceeds to step 404, where an endoscopic suture cinching device 54 is provided. The device 54 may be provided to the physician 14 during and / or after a medical procedure, such as a polypectomy. During the medical procedure, the physician 14 may perform a biopsy from the patient 12 by removing a polyp using a biopsy tool 50 (e.g., biopsy forceps). The biopsy tool 50 may be placed within the working channel 38 of the endoscope 18. The physician 14 may then use an optional suturing tool to suture the perforation. In various embodiments, the suturing tool may be attached to the exterior of the distal end 23 of the insertion tube 22. Various embodiments of the endoscope 18 may include one or more working channels 38.

[0030] The exemplary embodiment works with a variety of sutures and / or endoscopic suturing devices. For example, the exemplary embodiment advantageously does not require pre-loading the suture into the suture cinching device 54 or threading the suture through the accessory port 37 of the endoscope 18. Advantageously, the suture cinching device 54 may be used to cinch a suture that has previously been applied to the patient 12 (e.g., to a perforation) using an integrated or separate stitching tool.

[0031] The process proceeds to step 406, in which the cinch deployment system 62 is positioned within the working channel 38 of the endoscope 18. To that end, the distal end of the delivery shaft 74 may be positioned with the access port 37 of the endoscope 18. FIGS. 5A-5B schematically show the delivery shaft 74 advancing into the access port 37. The delivery shaft 74 may be plunged into the access port 37. As shown, the delivery shaft 74 may advantageously bend in a manner similar to the insertion tube 22. It should further be understood that the endoscope 18 and cinching device 54 are not necessarily drawn to scale; however, the various components are shown here for purposes of discussion.

[0032] In step 408, the process extends the suture capture portion 68 from the working channel of the endoscope 18. Based on the technique of the physician 14 and how much space is available within the body of the patient 12, the delivery housing 72 may also be extended completely out of the working channel 38, partially outside the working channel, or even inside the working channel 38. FIG. 5C schematically illustrates the suture capture portion 68 extended from the working channel 38, according to an exemplary embodiment of the invention. In FIG. 5C, the suture capture portion 68 is shown as a snare. However, some embodiments may include hooks and / or other shapes configured to capture the suture. In preferred embodiments, the suture capture portion 68 is flexible. In various embodiments, the suture capture portion 68 may expand after or as it is extended out of the delivery housing 72 and / or anchor 70. In various embodiments, the suture capturing portion 68 defines an opening 79 that is larger than the diameter of the lumen 73. This advantageously allows the snare / hook to easily capture the suture 78. Due to its flexibility, the snare / hook (capturing portion) can be retracted into the delivery catheter (e.g., delivery housing 72) and / or anchor 70.

[0033] To that end, the suture capture portion 68 may be formed from a wire. For example, the suture capture portion 68 may be a thin nitinol or stainless steel wire. The capture portion 68 (e.g., a wire) may have a thickness between about 0.005 inches (0.0127 cm) and about 0.025 inches (0.0635 cm). Among other shapes, the capture portion 68 may have a circular, rectangular, square, oval, or hexagonal cross-section. The capture portion may be formed from solid wire, multi-strand wire, stamped material, injection-molded plastic such as PEEK, polycarbonate, polypropylene, and / or ABS, among others. However, the suture capture portion 68 can take a variety of forms. For example, the suture capture portion and the suture may be magnetically attractive to one another. Alternatively, the suture capture portion may have an adhesive configured to grip the suture.

[0034] In various embodiments, the capturing portion 68 can be formed as a snare or loop that is biased toward an open configuration (e.g., the open position shown in FIG. 5C). FIG. 6A schematically illustrates a portion of the suture capturing portion 68 beginning to extend from the delivery housing 72. In this view, the insertion tube 22 has been omitted for clarity. However, it should be understood that the delivery housing 72 is positioned within the working channel 38 of the insertion tube 22. (See, e.g., FIG. 2C). As shown, when the loop is within the delivery housing 72, the delivery housing 72 holds the loop in a closed position.

[0035] FIG. 6B schematically illustrates a cross-sectional view of a cinch deployment system 62 according to an exemplary embodiment. As shown, the suture capture portion 68 is extended further than shown in FIG. 6A. The cinch anchor 70 has a lumen 73 through which the suture capture portion 68 extends. To this end, the suture capture portion 68 can be extended out of the working channel 38 by the physician 14 pushing on the handle frame 58, which is coupled to the proximal end of the drive wire 60. As the drive wire 60 is pushed, the suture capture portion 68 is advanced and extended out of the lumen 73 of the anchor 70.

[0036] In various embodiments, the suture capture portion is coupled to a cinch lock 66. The cinch lock 66 is configured to retain the captured suture within the cinch anchor 70. To that end, the inner diameter of the lumen 73 may be configured to provide an interference fit with the cinch lock 66. Specifically, the suture is captured between the cinch lock 66 and the cinch anchor 70 when the suture capture portion 68 is fully retracted into the cinch anchor 70. The cinch anchor 70 may also have a mating shoulder 76 that prevents the cinch lock 66 from being further retracted into the working channel 38, as will be described in more detail below. The cinch lock 66 may have a cross-sectional shape that is rectangular, square, circular, triangular, diamond-shaped, or any combination thereof.

[0037] After the suture capture portion 68 is extended, the suture is captured in step 410. FIG. 7A schematically illustrates the suture capture portion 68 capturing a suture 78, according to an exemplary embodiment of the present invention. As shown in FIG. 7A, the suture 78 may be threaded through an opening 79 in the suture capture portion 68. Alternatively, the suture capture portion 68 may be positioned over the free end of the suture 78. In some other embodiments, the suture 78 may be hooked, clipped, wrapped, or otherwise retained within the suture capture portion 68. Additionally, various embodiments may capture the suture 78 using a tool 50 to facilitate capturing. For example, a needle, clamp, and / or forceps may be used to assist the capture portion 68 in capturing the suture 78.

[0038] The process then proceeds to step 412, where the suture capture portion 68 is retracted into the cinch anchor 70 to cinch up the suture 78. Figures 7B-7E schematically illustrate the captured suture 78 being retracted into the anchor 70, according to an exemplary embodiment. As shown in Figure 7B, the delivery housing 72 may be positioned within the working channel 38 (shown in dashed lines) of the insertion tube 22. However, as shown in Figure 7C, the delivery housing 72 may extend out of the working channel 38. Thus, in some embodiments, the suture 78 may be retracted into the cinch anchor 70 and / or the delivery housing 72, which may or may not be inside or extending from the working channel 38. The physician 14 pulls on the handle frame 58 to retract the drive wire 60. The drive wire 60 is coupled to the suture capture portion 68, and therefore, when the drive wire 60 is retracted, the suture capture portion 68 is also retracted. As the suture capture portion 68 captures the suture 78, the suture 78 is also pulled toward the delivery housing 72 and anchor 70. Eventually, as shown in FIG. 7E, the suture 78 is pulled into the anchor 70. Additionally, the cinch lock 66 is also pulled into the cinch anchor 70. In various embodiments, the suture 78 is tensioned by pulling back on the suture 78 or the insertion tube 22 and then moving the delivery housing 72 closer to the tissue at the incision to ensure the cinch is tight.

[0039] 8A schematically illustrates a cross-sectional view of the distal end of a cinch deployment system 62 in accordance with an exemplary embodiment of the present invention. As shown, the suture capture portion 68 and cinch lock 66 are retracted into the cinch anchor 70. The cinch lock 66 rests against a shoulder 76 formed by the inner diameter of the lumen 73. Additionally, or alternatively, the inner diameter of the lumen may be tapered. The physician 14 pulls the handle frame 58 tight enough so that the suture 78 is sandwiched between the cinch lock 66 and the cinch anchor 70. Thus, the suture 78 is cinched by the cinch mechanism.

[0040] The process then proceeds to step 414, where the cinch lock 66 is disengaged from the capturing portion 68. Figure 8B schematically illustrates the cross-sectional view of Figure 8A after the cinch lock 66 has disengaged from the capturing portion 68. The physician 14 can pull the drive wire 60 coupled with the capturing portion 68. The capturing portion 68 and cinch lock 66 are configured such that the capturing portion 68 disengages after a threshold force is met. Thus, the suture capturing portion 68 can be removed from the patient 12.

[0041] The process then proceeds to step 416, which deploys the cinched suture 78. Specifically, the cinch anchor 70, which is currently coupled to the cinch lock 66 and suture 78, is deployed. The physician can press the drive wire 60 against the cinch anchor 70 and / or cinch lock 66 (before or after disconnecting the suture capture portion 68 from the drive wire 60). In some embodiments, the cut / disengaged capture portion 68 may be positioned between the drive wire 60 and the cinch anchor 70 and / or cinch lock 66. Nevertheless, exemplary embodiments may consider the drive wire 60 to be “squeezing” the cinch anchor 70 and / or cinch lock 66 when deploying the cinch anchor 70, even if the cut snare wire 68 is physically present between the drive wire 60 and the anchor 70 or lock 66. After the threshold force is met, the cinch anchor 70 is removed from the delivery housing 72 and remains within the patient 12.

[0042] Figure 9A schematically illustrates a perspective view of the cinch anchor 70 when a suture 78 is held by the cinch lock 66, in accordance with an exemplary embodiment of the present invention. Figure 9B schematically illustrates a cross-sectional view of the cinch anchor 70 when a suture 78 is held by the cinch lock 66, in accordance with an exemplary embodiment of the present invention. As shown, the inner diameters of the cinch lock 66 and the cinch anchor 70 create an interference fit 80. The interference fit 80 crushes the suture 78 therein, forming a crimp and holding the suture 78 against the suture anchor. Thus, the suture 78 is now cinched up.

[0043] The process proceeds to step 418, which asks whether there are more sutures to be cinched. If yes, the process returns to step 404, which provides an endoscopic suture cinching device (e.g., including a suture capture portion 68 and an engaged cinch lock 66). In some embodiments, the suture cinching device is removed from the working channel 38, and endoscopic scissors may be used to cut the suture 78. The process is then repeated substantially as described above until the suture 78 is cinched. In some embodiments, both ends of the suture 78 are cinched, one at a time. In some other embodiments, both ends of the suture 78 may be cinched using a single anchor 70, capture portion 68, and cinch lock 66. If there are no more sutures 78 to be cinched, the process ends.

[0044] It will be apparent to those skilled in the art that the exemplary embodiment provides multiple advantages to the physician 14 and the patient 12. Specifically, the exemplary embodiment advantageously allows for cinching of the suture 78 anywhere along its length inside the body of the patient 12. The exemplary embodiment allows for cinching of the suture 78 as many times as necessary. Furthermore, the exemplary embodiment advantageously reduces the steps required by the physician to perform the suturing process. The exemplary embodiment advantageously allows for suturing with or without pre-loading the suture 78 outside the patient's body. Furthermore, the exemplary embodiment allows for the use of short sutures so that the free ends of the suture do not extend outside the patient's body. The sutures can be, for example, 1 inch to 10 inches. Thus, the exemplary embodiment can work with short or long sutures because the cinch does not need to be loaded proximal to the working channel.

[0045] 10A-10D schematically illustrate alternative configurations of a cinch 64 according to exemplary embodiments of the present invention. For example, FIG. 10A schematically illustrates an exemplary hook suture capture portion 68. The hook may be formed from snare wires 68 and may include a first snare wire 68A, a second snare wire 68B, and a third snare wire 68C. In some embodiments, the third snare wire 68C may be normally closed but may be biased open by a portion of the anchor 70.

[0046] FIG. 10B schematically illustrates an exemplary ball-snare suture capturing portion 68. Lock 66 is shown as a ball crimp configured to wrap around suture 78 to capture it. FIG. 10C schematically illustrates an exemplary wrap snare suture capturing portion 68. Lock 66 may be a crimp configured to wrap around suture 78 to capture it. FIG. 10D schematically illustrates suture capturing portion 68 as an exemplary forked snare 500. Lock 66 is a forked crimp 130B configured to capture suture 68. In some embodiments, forked crimp 130B may include two prongs, as shown. Alternatively, in some embodiments, forked crimp 130B may include one or more prongs (e.g., four prongs separated by a 90-degree rotation). In some embodiments, anchor 70 may include prong crimp cavity 114 to receive at least a portion of forked crimp 130B.

[0047] 11-14 schematically illustrate the process of capturing and locking a suture 78 to an anchor 70 using various cinches 64 shown in FIGS. 10A-10D, respectively. As shown in FIG. 14, in some embodiments, the suture capture portion may be integrated with and / or extend beyond the cinch lock 66.

[0048] 15A-15G schematically illustrate alternative embodiments of a suture capture portion 68 in accordance with exemplary embodiments of the present invention. As shown in FIG. 15A, the suture capture portion 68 may be a stretched and bent wire. In various embodiments, the suture capture portion 68 may be formed so that it is biased toward a bent configuration when uncompressed. The capture portion 68 may be flexible and / or resilient. While the capture portion 68 is inside the delivery housing 72, its maximum dimension D3 in a direction perpendicular to the axis A1 is smaller than the diameter D1 of the delivery housing 72 and the diameter D2 of the lumen 73. However, when the capture portion 68 is outside the delivery housing 72 and / or the anchor 70, the resilient portion 68 returns to its normal bent configuration. This normal configuration may have a maximum dimension D3 that is greater than the diameter D1 of the housing 72 or the diameter D2 of the lumen 73.

[0049] 15B schematically illustrates a fully extended snare wire 68. The wire 68 may form an opening 79 configured to entrap and guide a suture 78 toward the cinch lock 66. FIGS. 15C-15E schematically illustrate the rotated suture capture portion 68, including the captured suture 78, being gradually retracted into the housing 72.

[0050] FIG. 15F schematically illustrates a perspective view of the delivery housing 72 of FIGS. 15A-15E. The cinch lock 66 is retracted and seated within the lumen 73 of the anchor 70. As shown, the maximum dimension D3 of the suture capture portion 68 is smaller than the diameter D1 of the delivery housing 72 and the diameter D2 of the lumen 73 (particularly the diameter D2 of the lumen 73 at the location where the cinch lock 66 forms an interference fit with the lumen 73, such as at the shoulder 76). It should also be understood from FIGS. 15A and 15F that in various embodiments, the dimension D3 of the capture portion 68 can expand to exceed the diameter of the lock 66 when extended. Similarly, the dimension D3 of the capture portion 68 can return to being smaller than the diameter of the lock 66 when retracted.

[0051] 15G schematically illustrates a cutaway view of the delivery housing 72 of FIGS. 15A-15E after the snare wire 68 has disengaged from the locking mechanism. The snare wire 68 disengages from the crimp formed by the lock 66 when the handle slide 56 is used to pull the puller wire 60. The hook crimp and short wire 68 can remain within the anchor 70, but the suture 78 becomes jammed and deformed between the snare crimp formed by the lock 66 and the anchor housing 70.

[0052] FIG. 16 schematically illustrates the rotation feature of the cinching device 54 in accordance with an exemplary embodiment of the present invention. As previously described, the cinching device 54 may be coupled to the endoscope 18. In the exemplary embodiment, the handle 51 may be rotated (e.g., relative to the coupler 61) to rotate the cinch 64. As shown, the coupler 61 does not rotate. In some embodiments, the coupler 61 may couple to the accessory port 37. However, in some other embodiments, the coupler 61 does not couple to the accessory port 37. The coupler 61 maintains its orientation (e.g., relative to the endoscope 18) as the handle 51 and cinch 64 (as well as the rod 60) rotate. Thus, the capturing portion 68 is advantageously rotatable to facilitate easy capture of the suture 78. For example, rotation allows for repositioning the orientation of a snare loop or hook to an ideal position for capturing the suture 78. To that end, in various embodiments, the puller wire 60 is attached to the handle slider 56 and the outer coil 65 (shown in FIG. 6B) is attached to the coupler 61. This allows for relative rotation of the drive wire 60, and therefore the cinch 64, with respect to the flexible tubing 22 and coil 65.

[0053] In various embodiments, handle 51 is external to working channel 38 and is operated by physician 14. To fit through working channel 38, the delivery shaft is preferably long for endoscopic procedures (e.g., about 150 cm to about 250 cm).

[0054] 17A-17F schematically illustrate the operation of the handle of the cinching device 54 according to an exemplary embodiment of the present invention. FIG. 17A schematically illustrates the capturing portion 68 inside the delivery housing 72. FIG. 17B illustrates the handle slider 56 fully depressed and the capturing portion 68 extending outward from the delivery housing 72. FIG. 17C schematically illustrates a captured suture 78. For example, in the case of a snare, an exemplary embodiment uses a needle to thread the suture 78 through the snare 68. In the case of a snare hook, an exemplary embodiment uses a hook 68 to capture the suture 78. Although not shown, the handle 51 can be rotated to facilitate capturing the suture 78.

[0055] FIG. 17D schematically shows the capturing portion 68 being partially retracted inside the delivery housing 72 to begin bringing the suture 78 inside the anchor 70. As shown, the handle slider 56 is partially retracted to partially retract the capturing portion 68. FIG. 17E schematically shows the handle slider 56 further retracted. Thus, the suture 78 becomes caught between the crimp and the anchor 70. As the pull wire 60 is further pulled, the snare wire, or a portion thereof, is released (e.g., severed) from the crimp. FIG. 17F schematically shows the cinch lock 66 being deployed by again pushing the handle slider 56 to cause the drive wire 60 to place the anchor 70.

[0056] While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions described herein and / or obtaining one or more of the results and / or advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application for which the teachings of the present invention are used. Those skilled in the art will recognize many equivalents to the specific inventive embodiments described herein, or will be able to ascertain such equivalents using no more than routine experimentation. It is therefore to be understood that the foregoing embodiments have been presented by way of example only, and that, within the scope of the appended claims and their equivalents, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the inventive scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0057] Various inventive concepts may be embodied as one or more methods, examples of which are provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed in which actions are performed in an order different from that illustrated, and such embodiments may include performing some actions simultaneously, even though shown as sequential actions in the exemplary embodiments.

[0058] While the foregoing discussion discloses various exemplary embodiments of the present invention, it will be understood that those skilled in the art could make various modifications which would obtain some of the advantages of the present invention without departing from the true scope of the invention. (Item 1) 1. A method of cinching a suture, comprising: a suture capture portion configured to capture the suture; a cinch lock coupled to the suture capture portion; and Scintigraphic anchor with a lumen providing a cinch comprising: extending the suture capture portion out of the lumen to capture the suture; retracting the suture capture portion into the lumen of the scintillator anchor; cinching the suture between the cinch lock and the cinch anchor; A method comprising: (Item 2) deploying the scintillator within the patient by pushing the handle to overcome a threshold deployment force; disengaging the suture capture portion from the cinch lock by pulling the handle to overcome a threshold disengagement force; Item 1, the method of claim 1 further comprising: (Item 3) extending the suture trap out of a working channel of an endoscope; positioning the cinch within a working channel of an endoscope; Item 1, the method of claim 1 further comprising: (Item 4) Item 10. The method of item 1, wherein the suture capture portion comprises a snare. (Item 5) Item 10. The method of item 1, wherein the suture capture portion is flexible. (Item 6) Item 10. The method of item 1, wherein the suture capture portion comprises a wire. (Item 7) 2. The method of claim 1, further comprising stitching the suture within the patient prior to capturing the suture. (Item 8) Item 10. The method of item 1, wherein the suture is cinched by an interference fit between the cinch anchor and the cinch lock. (Item 9) Item 10. The method of item 1, wherein the cinch is coupled to a delivery shaft of a handheld cinching device, the method including the step of positioning the delivery shaft within an accessory port of the endoscope. (Item 10) Item 10. The method of item 1, further comprising rotating the suture capture portion relative to the lumen. (Item 11) 1. A tightening system comprising: an endoscope having an insertion tube, the insertion tube having at least one working channel; 1. A cinching device comprising: a handle movably coupled to a flexible drive wire, the handle configured to move the drive wire proximally or distally within a working channel of an endoscope; a suture capture portion coupled to a distal end of the drive wire, wherein movement of the drive wire in a distal direction causes movement of the suture capture portion in a distal direction; a scintillator having a lumen through which the suture capture portion travels; a cinch lock coupled to the suture capture portion, wherein movement of the suture capture portion in a distal direction causes movement of the cinch lock in a distal direction and movement of the suture capture portion in a proximal direction causes movement of the cinch lock in a proximal direction; Equipped with a cinching device, wherein the inner diameter of the lumen is configured to provide an interference fit with the cinch lock when the cinch lock enters the lumen; A tightening system comprising: (Item 12) Item 12. The cinching system of item 11, wherein the cinch lock is releasably coupled to the suture capture portion. (Item 13) Item 12. The cinching system of item 11, wherein the cinch anchor is releasably coupled to the delivery housing. (Item 14) Sutures stitched within the patient Item 12. The tightening system of item 11, further comprising: (Item 15) Item 12. The cinching system of item 11, wherein the scinch anchor has a securing portion configured to couple the scinch anchor to a delivery housing. (Item 16) a delivery housing configured to fit within a working channel of an endoscope; a scintillator coupled to the delivery housing, the scintillator having a lumen extending from a proximal end to a distal end; a suture capture portion movably positioned within the lumen, the suture capture portion configured to capture a suture; a cinch lock coupled to the suture capture portion, the cinch lock configured to provide an interference fit with an inner diameter defined by the lumen when the cinch lock enters the lumen; A tightening device comprising: (Item 17) Item 17. The cinching device of item 16, further comprising a user-operated drive wire coupled with the suture capture portion. (Item 18) Item 17. The cinching device according to item 16, wherein the suture capture portion is flexible. (Item 19) Item 17. The cinching device of item 16, wherein the suture capture portion comprises a wire. (Item 20) Item 17. The cinching device according to item 16, wherein the suture capture portion comprises a snare.

Claims

1. 1. A tightening system comprising: an endoscope having an insertion tube, the insertion tube having at least one working channel; 1. A cinching device comprising: a handle movably coupled to a flexible drive wire, the handle configured to move the drive wire proximally or distally within a working channel of an endoscope; a suture capture portion coupled to a distal end of the drive wire, wherein movement of the drive wire in a distal direction causes movement of the suture capture portion in a distal direction; a scintillator having a lumen through which the suture capture portion travels; a cinch lock coupled to the suture capture portion, wherein movement of the suture capture portion in a distal direction causes movement of the cinch lock in a distal direction and movement of the suture capture portion in a proximal direction causes movement of the cinch lock in a proximal direction; Equipped with a cinching device, wherein the inner diameter of the lumen is configured to provide an interference fit with the cinch lock when the cinch lock enters the lumen; A tightening system comprising:

2. The cinching system of claim 1 , wherein the cinch lock is releasably coupled to the suture capture portion.

3. The cinching system of claim 1 , wherein the cinch anchor is releasably coupled to a delivery housing.

4. Sutures stitched within the patient The cinching system of claim 1 further comprising:

5. The cinching system of claim 1 , wherein the cinch anchor has a securing portion configured to couple the cinch anchor with a delivery housing.

6. a delivery housing configured to fit within a working channel of an endoscope; a scintillator coupled to the delivery housing, the scintillator having a lumen extending from a proximal end to a distal end; a suture capture portion movably positioned within the lumen, the suture capture portion configured to capture a suture; a cinch lock coupled to the suture capture portion, the cinch lock configured to provide an interference fit with an inner diameter defined by the lumen when the cinch lock enters the lumen; A tightening device comprising:

7. The cinching device of claim 6 , further comprising a user-operated drive wire coupled with the suture capture portion.

8. The cinching device of claim 6 , wherein the suture capture portion is flexible.

9. The cinching device of claim 6 , wherein the suture capture portion comprises a wire.

10. The cinching device of claim 6 , wherein the suture capture portion comprises a snare.

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