Tissue collection spiral device

Abstract

A tissue grasping device for use with an endoscope may include a sheath, a control wire slidably disposed within the sheath, and a helical coil disposed on and attached to the control wire. The helical coil may include a proximal region where adjacent windings touch and a distal region where adjacent windings are spaced apart. The helical coil may have a sharp distal tip.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 62 / 930,700, filed on November 5, 2019, entitled “Tissue Collection Auger,” the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to devices for suturing tissue, and more particularly to devices that work with an endoscope or similar device for endoscopic suturing of tissue. Background Art

[0004] Various endoscopic procedures may result in defects (or wounds) that are too large for hemostatic clips to easily bridge and thus help close the defect. Examples of such endoscopic procedures include resection of large lesions, tunneling beneath the mucosal layer, full-thickness resection of tissue, parenteral treatment of other organs, and repair of post-operative problems such as post-operative leaks, failed surgical sutures, and anastomotic leaks. Endoscopic procedures also include bariatric revision procedures. Each of the known devices and methods for endoscopically closing large defects has advantages and disadvantages. Summary of the Invention

[0005] The present disclosure relates to several alternative designs, materials, and methods for devices for endoscopically closing large defects. In one example, a tissue grasping device for use with an endoscope includes a sheath defining a sheath lumen, a control wire slidably disposed within the sheath lumen, a tubular connector attached to a distal portion of the control wire, and a helical coil disposed on and attached to the tubular connector such that the tubular connector is positioned between an outer surface of the control wire and an inner surface of the helical coil, the helical coil including a proximal region where adjacent windings are in contact and a distal region where adjacent windings are spaced apart, the helical coil having a sharp distal tip.

[0006] Alternatively or additionally to any of the above examples, the tubular connector is secured against axial movement relative to the control line.

[0007] Alternatively or additionally to any of the above examples, the tissue grasping device further includes an inner sheath slidably disposed within the sheath lumen, the inner sheath having a lumen configured to receive a control wire.

[0008] As an alternative or in addition to any of the above examples, the inner jacket has a star-shaped cross-section.

[0009] Alternatively or additionally to any of the above examples, the inner sheath is not attached to the helical coil.

[0010] Alternatively or additionally to any of the above examples, the control wire includes a visual indicator configured to indicate rotational movement of the control wire.

[0011] Alternatively or additionally to any of the above examples, the sheath lumen includes a proximal portion having a first inner diameter and a distal portion having a second inner diameter greater than the first diameter, wherein the helical coil is disposed within the distal portion of the sheath lumen.

[0012] Alternatively or additionally to any of the above examples, the helical coil has an outer diameter that is greater than an inner diameter of the proximal portion.

[0013] Alternatively or additionally to any of the above examples, the control wire is not secured to any structure proximal to the helical coil.

[0014] As an alternative or in addition to any of the above examples, the tissue grasping device further includes a heat shrink tubing disposed over at least a portion of the proximal region of the helical coil and over at least a portion of the control wire adjacent to the helical coil.

[0015] In another example, a tissue grasping device for use with an endoscope includes a sheath defining a sheath lumen, a control wire slidably disposed within the sheath lumen, a helical coil disposed on and attached to a distal portion of the control wire, the helical coil including a proximal region where adjacent windings are in contact and a distal region where adjacent windings are spaced apart, the helical coil having a sharp distal tip, and

[0016] The control wire is not secured to any structure proximal to the helical coil.

[0017] Alternatively or additionally to any of the above examples, the helical coil is attached to the control wire by an adhesive.

[0018] Alternatively or additionally to any of the above examples, the proximal region of the helical coil includes a first region where adjacent windings touch and a second region proximal to the first region, wherein adjacent windings in the second region are spaced apart.

[0019] Alternatively or additionally to any of the above examples, the tissue grasping device further includes a connecting element disposed within the second region, the connecting element configured to connect the helical coil to the control wire.

[0020] As an alternative or in addition to any of the above examples, the connecting element is a weld.

[0021] Alternatively or additionally to any of the above examples, the control wire includes a visual indicator configured to indicate rotational movement of the control wire.

[0022] Alternatively or additionally to any of the above examples, the sheath lumen includes a proximal portion having a first inner diameter and a distal portion having a second inner diameter greater than the first diameter, wherein the helical coil is disposed within the distal portion of the sheath lumen.

[0023] Alternatively or additionally to any of the above examples, the outer diameter of the helical coil is greater than the inner diameter of the proximal region.

[0024] Alternatively or additionally to any of the above examples, the proximal region fits tightly over the control wire.

[0025] In another example, a tissue grasping device for use with an endoscope includes an outer sheath defining a sheath lumen, a control wire slidably disposed within the sheath lumen, an inner sheath slidably disposed within the sheath lumen, the inner sheath having a lumen configured to receive the control wire, a tubular connector attached to a distal portion of the control wire, and a helical coil disposed on and connected to the tubular connector such that the tubular connector is positioned between an outer surface of the control wire and an inner surface of the helical coil, the helical coil including a proximal region where adjacent windings are in contact and a distal region where adjacent windings are spaced apart, the helical coil having a sharp distal tip, wherein the tissue grasping device is free of any structure secured to the proximal end of the helical coil.

[0026] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] A more complete understanding of the present disclosure may be obtained from the following description considered in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a side partial cross-sectional view of an illustrative tissue grasping device according to an example of the present disclosure;

[0029] Figure 2 yes Figure 1 a cross-sectional view of a distal portion of an illustrative tissue grasping device;

[0030] Figure 3 yes Figure 1 a perspective view of an illustrative tissue grasping device shown in an extended position;

[0031] Figure 4 is with Figure 1 a perspective view of a handle assembly for use with an illustrative tissue grasping device;

[0032] Figure 5 is a perspective view of a portion of an illustrative tissue grasping device according to another example of the present disclosure;

[0033] Figure 6 yes Figure 5 a cross-sectional view of an illustrative tissue grasping device taken along line 6-6;

[0034] Figure 7is a side partial cross-sectional view of a portion of an illustrative tissue grasping device according to another example of the present disclosure;

[0035] Figure 8 is a side view of a portion of an illustrative tissue grasping device according to another example of the present disclosure;

[0036] Figure 9 is a perspective view of a portion of an illustrative tissue grasping device according to another example of the present disclosure;

[0037] Figure 10 yes Figure 9 a cross-sectional view of an illustrative tissue grasping device;

[0038] Figure 11 is a perspective view of a portion of an illustrative tissue grasping device according to another example of the present disclosure;

[0039] Figure 12 yes Figure 11 a cross-sectional view of an illustrative tissue grasping device;

[0040] Figure 13 is a side cross-sectional view of a portion of an illustrative tissue grasping device according to another example of the present disclosure;

[0041] Figure 14 is a side view of a portion of an illustrative tissue grasping device according to another example of the present disclosure; and

[0042] Figures 15 to 19 A tissue grasping device is shown used with a suturing device in a tangential approach according to an example of the present disclosure, which can be used to sew thicker tissues and / or larger wounds, such as those encountered during bariatric surgery.

[0043] Although the present disclosure is susceptible to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the present disclosure is not intended to limit the present disclosure to the particular embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0044] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0045] Definitions for certain terms are given below and should be used unless a different definition is given in the claims or elsewhere in this specification.

[0046] Whether or not explicitly stated, all numerical values ​​herein are assumed to be modified by the term "about". The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" can be expressed as including numbers rounded to the nearest significant figure.

[0047] The recitations of numerical ranges by endpoints include all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0048] Although some suitable sizes, ranges and / or values ​​are disclosed with respect to various components, features and / or specifications, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may deviate from those explicitly disclosed.

[0049] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to singular as well as plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" generally includes "and / or" unless the content clearly dictates otherwise.

[0050] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different figures are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the present disclosure. The depicted illustrative embodiments are intended to be examples only. Selected features of any illustrative embodiment may be incorporated into additional embodiments unless expressly stated to the contrary.

[0051] The present disclosure relates to devices configured for use in conjunction with an endoscope or similar delivery device to close wounds within the body. In some cases, the tissue grasping devices described herein can be configured so that they can be used within a single working or available channel of an endoscope and, in some cases, can be operated by a single person, although in some cases a second person may be involved. In some cases, the tissue grasping devices described herein can be viewed as operating along a single operating line. The device itself can translate distally and proximally within the working channel, and the handle portion itself can translate distally and proximally along the same operating line as the tissue grasping device is advanced and retracted. The device can be configured to enable tissue to be held in a position suitable for suturing.

[0052] The tissue grasping devices described herein can be used with suturing devices, such as those described in U.S. Patent Publication No. 2018 / 0235604, published on August 23, 2018, the entire contents of which are incorporated herein by reference. In addition, the tissue grasping devices can be used in addition to suturing systems for any application requiring tissue grasping and / or collection.

[0053] Figure 1 An exemplary tissue grasping device 100 is shown, which may be considered to be configured for use in conjunction with a delivery system including a lumen extending through the delivery system. For example, the delivery system may be an endoscope having a working channel. The delivery system may also be a catheter. The tissue grasping device 100 may be configured to grasp tissue for suturing through an endoscope. It should be understood that the tissue grasping device may stabilize a selected portion of tissue for suturing. The tissue grasping device 100 may include a sheath 10 having a proximal end 12, a distal end 14, and a sheath lumen 18 extending therebetween. The sheath 10 may be a flexible tube shaped and configured for insertion through an endoscope. In some examples, the proximal end 12 of the sheath may be flared to attach a handle, such as Figure 1 As shown. The distal end 14 (including the lumen 18) may also be flared (not shown). In other examples, the proximal end 12 may be cylindrical. The control wire 20 is slidably disposed within the sheath lumen 18. The control wire 20 may be an elongated flexible elastic wire, a flexible torque-transmitting multifilament cable, a laser-cut hypotube, or a catheter. The control wire 20 may be a solid structure. In other examples, the control wire 20 may have an inner lumen. The control wire 20 can slide freely longitudinally and rotate within the sheath 10. The control wire 20 may be nitinol, stainless steel, or other metal that provides the desired flexibility. Nitinol allows flexibility but does not kink.

[0054] A helical coil 30 having a plurality of windings may be disposed on and attached to a distal portion of the control wire 20, such as Figure 1As shown. The helical coil 30 can be attached to the control wire 20 by welding, adhesive, or other connection methods to provide a permanent connection. The helical coil 30 may include a proximal region 32, a distal region 34, and an intermediate region 36 therebetween. In the proximal region 32, adjacent windings may be in contact with each other, while in the distal region 34, adjacent windings may be spaced apart. The contacting windings in the proximal region 32 of the coil provide stiffness to prevent the helical coil 30 from bending under vertical loads. The windings in the intermediate region 36 may have a non-constant pitch, resulting in a gradual increase in spacing from adjacent windings in contact in the proximal region 32 to spaced-apart windings in the distal region 34. The distal end 24 of the control wire 20 may extend into the distal region 34 of the helical coil 30 to prevent tissue from being trapped in the small spaces between the windings in the intermediate region 36. The helical coil 30 may have a sharp distal tip 38. The helical coil 30 may be a solid round metal wire and may be formed to have a diameter larger than that of the control wire. When used together with a closure system, the spiral shape generally provides superior tissue gripping capabilities. The closure device needs to grasp the tissue and then pull it into the suture window. By rotating the control line 20 in a first direction, the sharp distal end 38 of the spiral coil 30 is easily rotated into the tissue and is well maintained on the tissue when pulled. In some examples, the distal region 34 of the spiral coil 30 may include one to ten or three to five complete spiral turns, which may help to fasten the tissue for suturing. Compared to standard forceps-type graspers that have a tendency to slide in the presence of fluid, the spiral coil 30 may also be advantageous for obtaining tissue in the presence of fluid, particularly in the stomach. After suturing, the spiral coil 30 is removed from the tissue by rotating the control line 20 in the opposite direction.

[0055] In some examples, the tissue grasping device 100 may include a tubular connector 40 attached to a distal portion of the control wire 20, just proximal to the distal end 24. The tubular connector 40 may be secured against axial movement relative to the control wire 20. In some examples, the tubular connector 40 may be welded or brazed to the control wire 20, or attached with an adhesive. In other examples, the tubular connector 40 may be crimped onto the control wire 20. The helical coil 30 may be disposed on and attached to the tubular connector 40 such that the tubular connector 40 is located between an outer surface of the control wire 20 and an inner surface of the helical coil 30. The tubular connector 40 may have a length such that it extends only below portions of the proximal region 32 and the intermediate region 36 of the helical coil 30, as shown. Figure 2As shown. The tubular connector 40 can be an elongated hollow tube, but can also be solid and include slots, slits, grooves, etc. In some examples, the helical coil 30 can be attached to the control wire 20 only via the tubular connector 40. In other examples, the helical coil 30 can be attached to the tubular connector 40 and also directly attached to the control wire 20. In some examples, the control wire 20 may not have any structure fixed to the control wire 20 on the proximal side of the helical coil 30. In particular, the control wire 20 may not have any structure attached to the proximal end of the helical coil 30. In such an example, the helical coil 30 is attached to the distal end of the control wire 20 without any structure provided at the proximal end of the helical coil 30 at the distal region of the control wire 20, such as a tubular element, sleeve, support, or additional member.

[0056] In some examples, the tissue grasping device 100 may include an inner sheath 50 slidably disposed within the sheath lumen 18 and over the control wire 20. The inner sheath 50 may have a lumen configured to receive the control wire 20 in a close-fitting manner such that the control wire 20 is free to slide longitudinally and rotate within the inner sheath 50 with minimal radial movement while maintaining the control wire 20 within the center of the sheath 10 and preventing the control wire 20 from kinking. The length of the inner sheath 50 may be less than the distance between the proximal region 32 of the helical coil 30 and the proximal end 12 of the sheath 10. The inner sheath 50 is not attached to the helical coil 30. The inner sheath 50 may be a cylindrical tube having an outer diameter that provides a close fit with the inner surface of the sheath lumen 18. In other examples, the inner sheath 50 may be formed as a single, unitary component with the sheath 10, as described below with reference to Figure 7 Descriptive.

[0057] The control line 20 can move longitudinally and rotationally within the sheath 10. Figure 3 As shown, pushing the control wire 20 causes at least a portion of the helical coil 30 to longitudinally move beyond the distal end 14 of the sheath 10. Because at least the distal region 34 of the helical coil 30 is distal to the distal end 14 of the sheath 10 and in contact with the tissue, rotation of the control wire 20 in a first direction causes the sharp distal tip 38 of the helical coil to penetrate the tissue. When the helical coil 30 is positioned substantially perpendicular to the tissue, continued rotation of the helical coil 30 in the first direction causes the sharp distal tip 38 to be driven deeper into the tissue in a spiral motion. If the helical coil 30 is positioned tangentially to the tissue, continued rotation in the first direction causes the sharp distal tip 38 to repeatedly enter and exit the tissue, temporarily holding two adjacent edges of the tissue together. Either position holds the tissue and allows the suturing device to sew the tissue together. The control wire 20 can then be rotated in the opposite direction to withdraw the helical coil 30 from the tissue. The presence of the control wire 20 passing through the intermediate region 36 prevents tissue from becoming trapped between the densely packed windings.

[0058] Figure 4An example of a user interface handle 90 for actuating the tissue grasping device 100 to longitudinally and rotationally move the control wire 20 is shown. The handle 90 may include a handle portion 92 having a proximal finger ring 94 and a translation handle 95 connected to the control wire 20. The translation handle 95 may slide along the handle portion 92 to advance and retract the helical coil 30 from the sheath 10. Figure 4 As shown, the translation handle 95 is in the forward position, indicating that the helical coil 30 is in the Figure 3 Sliding the translation handle 95 toward the finger ring 94 moves the helical coil 30 proximally into the sheath 10, as shown. Figure 1 As shown. Retracting the helical coil 30 into the sheath 10 while advancing along the working channel protects the sharp distal tip 38 from damage and protects surrounding tissue from damage from the sharp tip. The handle 90 may also include a rotatable control knob 96 directly connected to the control wire 20. Rotating the control knob 96 rotates the control wire 20 and the helical coil 30 at the distal end of the device.

[0059] In some examples, the inner sheath may have a non-circular cross-section. For example, the inner sheath 150 may have a star-shaped cross-section, such as Figure 5-6 As shown. The star-shaped inner sheath 150 can reduce friction with the inner surface of the sheath 10, thereby improving sliding properties. In other examples, the outer surface and / or inner surface of the inner sheath 150 can include a lubricating coating. Figure 6 The cross section shown in shows the flared region 15 on the proximal end 12 of the sheath 10 .

[0060] In another example, the tissue grasping device 200 may have inner and outer sheaths defined by a single integral piece. Figure 7 As shown, the sheath 210 may include a proximal portion 212 and a distal portion 214, wherein the inner diameter of the distal portion 214 is larger than the inner diameter of the proximal portion 212. The sheath 210 may include a step 211 from the inner diameter of the proximal portion 212 to the larger inner diameter of the distal portion 214, as shown. Figure 7 The step can be a gradual and uniform slope or a sudden step 211. Figure 7 The tissue grasping device 200 shown in FIG has an abrupt step 211. The proximal portion 212 of the sheath 210 can have an inner diameter that forms a tight fit around the control wire 220, which can provide smooth actuation and rotation of the control wire 220. The helical coil is disposed within the distal portion 214. In some examples, the distal portion 214 can include a flared distal end 215, including, for example, Figure 7 An enlarged lumen 218 is shown, which may facilitate proximal reinsertion of the coil 230 into the sheath 210 after the coil 230 has been fully extended distally out of the sheath 210. It will be appreciated that a flared distal end may be incorporated into any of the devices described herein.

[0061] Another example of a tissue grasping device 300 does not include an inner sheath, stepped extrusion, or outer sheath, such as Figure 8 As shown in FIG. The device consists solely of a control wire 320, a tubular connector 340, and a helical coil 330, without any sheath. The control wire 320 and helical coil 330 are always exposed. The tissue grasping device 300 is passed through the working channel of an endoscope and actuated by advancing the helical coil 330 out of the working channel. The working channel acts as an outer sheath.

[0062] exist Figure 9 and 10 In the example shown, the tissue grasping device 500 may include an outer sleeve 560 secured to the proximal end of the helical coil 530. The outer sleeve 560 may extend proximally of the proximal region 532 and may be secured to the control wire 520 via a connector 562. The connector 562 may be an adhesive, such as an epoxy, or welded, soldered, or a separate tubular connector. The tubular connector 540 may extend proximally of the helical coil 530 such that it extends into the lumen of the outer sleeve 560, as shown. Figure 10 The outer sleeve 560 can be attached to the tubular connector 540 using adhesive, solder, or welding. When in the extended position, the combination of the outer sleeve 560 and the tubular connector 540 can provide additional support for the helical coil 530.

[0063] In the above example, the transition between the proximal end of the helical coil and the control wire can be a steep step. In other examples, the tissue grasping device 600 can have a smoother transition by placing heat shrink tubing or wrap 670 on at least the proximal region 632 of the helical coil 630, on a portion of the tubular connector 640 extending proximally of the helical coil 630, and on a portion of the control wire 620 adjacent the proximal end of the helical coil 630. Figure 11 and 12 Heat shrink wrap 670 can provide a smooth, gradual ramp 672 between the outer diameter of helical coil 630 and control wire 620. If helical coil 630 extends too far out of the catheter, heat shrink wrap 670 can act as a smooth transition ramp when helical coil 630 is retracted into sheath 610.

[0064] In some examples, the control line 620 may also include markings or other visual indicators to visualize the rotation. Figure 11 As shown, the control wire 620 has a visual indicator comprising a spiral stripe pattern of two contrasting colors, which provides an indication of how much the control wire 620 has been rotated, and therefore the degree of rotation of the helical coil 630. In some examples, the markings may comprise spiral stripes of different colors extending along at least the proximal portion of the control wire 620. In other examples, the markings may be provided along the entire length of the control wire 620. When the heat shrink wrap 670 is present, the markings may be provided on the heat shrink wrap 670.

[0065] In some examples of tissue grasping device 700, tubular connector 40 may be eliminated and helical coil 730 may be configured such that the contraction force generated by the helical coil around control wire 720 secures helical coil 730 to control wire 720, such as Figure 13 In this example, the tissue grasping device 700 consists only of a control wire 720 and an attached helical coil 730. The helical coil 730 may have Figure 1 The tissue grasping device 700 may have a similar structure to the helical coil 30 shown, including a proximal region 732 where adjacent windings contact each other and a distal region 734 where adjacent windings are spaced apart. The control wire 720 may have features thereon that facilitate engagement with the helical coil 730. For example, the control wire 720 may include one or more grooves or ridges (not shown) configured to receive the windings of the control wire 720. In some examples, solder or adhesive may be added to secure the helical coil 730. Alternatively, if the material permits, direct welding may be used to secure the helical coil 730 to the control wire 720. In some examples, the tissue grasping device 700 may include the sheath 10 and / or inner sheath 50 discussed above.

[0066] In order to provide an increased bonding surface area for welding or adhesive connection, the proximal region 832 of the helical coil 830 can be divided into a first region 833 and a second region 835 disposed proximal to the first region 833, as shown in FIG. Figure 14 The windings in the first region 833 may remain in contact with each other, while the windings in the second region 835 may be separated, similar to the windings spaced apart in the distal region 834. A connecting element, such as solder or adhesive 839 may be applied to the second region 835, as shown. Figure 14 shown.

[0067] Figures 15 to 19 An illustrative, but non-limiting, example of a distal assembly 14c for performing tissue repair using a tangential approach is provided. For example, a tangential approach may be used when repairing a larger wound requiring suturing through thicker or more tissue. Bariatric procedures are examples of procedures that may benefit from a tangential approach. The distal assembly 14c and associated suture translation assembly are described in U.S. Patent Publication No. 2018 / 0235604, the entire contents of which are incorporated herein by reference. It should be understood that when performing the illustrated procedure, the distal assembly 14c may be secured to the distal end of an endoscope or other delivery device and may be used in conjunction with any of the suture translation assemblies described in the aforementioned patent publications.

[0068] Figure 15Defect 400 is shown within tissue 402. In some cases, defect 400 may include a remaining open portion 404 along staples or sutures 405. In some cases, a portion of defect 400 has been closed using staples 406, and in some cases, the remaining open portion 404 may be positioned such that stapling is inappropriate or difficult to perform, requiring suturing to close defect 400.

[0069] from Figure 16 Initially, distal assembly 14c is positioned relative to defect 400. Tissue grasping device 100 extends through tubular member 412, which is fixed relative to guide structure 27a and can be positioned so that sharp distal tip 38 of helical coil 30 can be rotated into tissue 414 adjacent to the remaining open portion 404 of defect 400. Since helical coil 30 is embedded in tissue 414, tissue 414 can be pulled upward by retracting tissue grasping device 100, as shown by arrow 416. As tissue 414 is pulled upward, as shown in FIG. Figure 17 As shown, suturing can begin. Figure 18 In FIG, it can be seen that the spiral coil 30 has reversed out of the tissue and the needle 16 has passed through the tissue 414 and has been captured by the end cap 34a, thereby pulling the suture 420 through the tissue 414. Figure 19 4, the suture 420 now extends through the tissue 414 on the first side 430 of the remaining open portion 404 of the defect 400. The suturing process can continue by repeating the above steps on the second side 432 of the remaining open portion 404 of the defect 400.

[0070] It should be understood that a variety of different materials can be used to form the devices described herein. In some cases, a variety of different metals can be used. Illustrative but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt chromium, and the like. For example, in some embodiments, the devices described herein can include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Other suitable polymers include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available, for example, from DuPont), and polyoxymethylene (POM). ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those available from DuPont ), polyamide (e.g., available from Bayer Or purchased from ElfAtochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, sold under the trade name Sold), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g., ), polysulfone, nylon, nylon-12 (e.g. available from EMS American Grilon ), perfluoro(propyl vinyl ether)

[0071] (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers thereof, polymer / metal composites, etc.

[0072] Those skilled in the art will recognize that the present disclosure may be embodied in a variety of forms in addition to the specific embodiments described and contemplated herein. Accordingly, departures may be made in form and detail without departing from the scope and spirit of the present invention as described in the appended claims.

Claims

1. A tissue grasping device for use with an endoscope, comprising: a sheath defining a sheath lumen; a control wire slidably disposed within the lumen of the sheath; a tubular connector fixedly attached to the distal portion of the control wire proximal to the distal end of the control wire; and A helical coil is disposed on and fixedly attached to the tubular connector so that the tubular connector is located between an outer surface of the control wire and an inner surface of the helical coil, the helical coil including a proximal region where adjacent windings are in contact and a distal region where adjacent windings are spaced apart, the helical coil having a sharp distal tip.

2. The tissue grasping device of claim 1, wherein the tubular connector is secured against axial movement relative to the control wire.

3. The tissue grasping device of claim 1 or 2, further comprising an inner sheath slidably disposed within the sheath lumen, the inner sheath having a lumen configured to receive the control wire. The tissue grasping device of claim 3 , wherein the inner sheath is not attached to the helical coil.

5. The tissue grasping device of claim 1, wherein the control wire includes a visual indicator configured to indicate rotational movement of the control wire.

6. The tissue grasping device of claim 1, wherein the sheath lumen comprises a proximal portion having a first inner diameter and a distal portion having a second inner diameter greater than the first inner diameter, wherein the helical coil is disposed within the distal portion of the sheath lumen.

7. The tissue grasping device of claim 6, wherein the outer diameter of the helical coil is greater than the inner diameter of the proximal portion.

8. The tissue grasping device of claim 1, wherein the control wire is not secured to any structure proximal to the helical coil.

9. The tissue grasping device of claim 1, further comprising a heat shrink tubing disposed over at least a portion of a proximal region of the helical coil and over at least a portion of the control wire adjacent the helical coil.

10. A tissue grasping device for use with an endoscope, comprising: an outer sheath defining an inner lumen of the sheath; a control wire slidably disposed within the lumen of the sheath; an inner sheath slidably disposed within the sheath lumen, the inner sheath having a lumen configured to receive the control wire; a tubular connector fixedly connected to the distal portion of the control wire proximal to the distal end of the control wire; and a helical coil disposed on and fixedly attached to the tubular connector such that the tubular connector is positioned between an outer surface of the control wire and an inner surface of the helical coil, the helical coil including a proximal region where adjacent windings are in contact and a distal region where adjacent windings are spaced apart, the helical coil having a sharp distal tip; The control wire is not fixed to any structure at the proximal end of the helical coil.

11. The tissue grasping device of claim 10, wherein the tubular connector is secured against axial movement relative to the control wire.

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