Recovery device
The method of attaching a mesh to a surgical snare loop using a heated polymeric layer addresses sliding and interference issues, ensuring secure and efficient object capture.
Patent Information
- Application Number
- JP2023193669
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2015-05-17
- Filing Date
- 2023-11-14
- Publication Date
- 2025-07-31
- Estimated Expiration
- 2035-09-18
AI Technical Summary
Existing surgical snare devices face issues with web members sliding or gathering at the tip of the loop, and clips or ringlets interfering with the capture of objects, making the procedure difficult and time-consuming.
A method of attaching a mesh to a loop member using a coated wire with a polymeric layer, where the mesh is adhered to the loop by heating the layer to make it sticky, and then cutting off excess mesh, allowing the loop to be compressed within a sheath and deployable for object capture.
The method provides a secure and efficient attachment of the mesh to the loop, preventing interference during object capture, enhancing the snare's functionality and ease of use.
Smart Images

Figure 0007716460000001 
Figure 0007716460000002 
Figure 0007716460000003
Abstract
Description
Technical Field
[0001] <Cross - Reference to Related Applications> This application claims priority and is dependent on both U.S. Provisional Patent Application No. 62 / 052,538, filed on September 19, 2014, with the title "Method of Attaching a Mesh to a Coated Loop Member of a Surgical Snare Device" and U.S. Provisional Patent Application No. 62 / 162,786, filed on May 17, 2015, with the title "Method of Attaching a Mesh to a Coated Loop Member of a Surgical Snare Device".
[0002] The entire contents of the above - mentioned applications are incorporated herein by reference.
[0003] This specification generally relates to surgical instruments. More specifically, this specification relates to a surgical snare device used to remove an object from a body lumen, and more particularly to a surgical snare device in which a mesh or net is fused and adhered to a coated loop member of the surgical snare device. This application also relates to a method of attaching a mesh to a loop member for a surgical snare device.
Background Art
[0004] Existing surgical devices for grasping and removing foreign objects from human organs or body cavities include mechanically - actuated forceps, mechanically - actuated snares, or mechanically - actuated baskets. Each of these surgical instruments is placed inside the body under visualization by endoscopy, fluoroscopy, and direct visualization.
[0005] A mechanically actuated snare comprises an assembly of a flexible web member attached to a loop of wire surrounded by a sheath. The loop of wire can automatically extend into an opening formed beyond the sheath, and as a result, the attached web member is opened into a capture pocket. The dimensions of the opening are controlled by the length of the wire advanced beyond the end of the sheath. In use, after the snare is positioned adjacent to the object, the wire is advanced beyond the end of the sheath until a loop larger than the object is formed. Then, the loop is positioned until the web member and the face of the loop surround the object. Then, the sheath is advanced to retract the wire so that the loop and the web member tighten and engage / capture the object.
Summary of the Invention
Problems to be Solved by the Invention
[0006] The web member is generally attached to the loop of wire by weaving and / or using clips or ringlets along the perimeter of the loop of wire. When retracting the loop into the sheath to tighten the object, the strand of the instrument that connects the web member to the loop may slide along the loop and compress at the tip-side end of the loop. Also, the web members may gather and be inserted between the object and the tip-side end of the loop. Similarly, the presence of clips or ringlets that join the web member to the loop may impede, make more difficult, and time-consuming the capture of the object.
[0007] Therefore, in this technical field, there is a need for an improved method of attaching or connecting a web member, mesh, or net to a loop member of a surgical snare device without interfering with the procedure.
Means for Solving the Problems
[0008] The following embodiments and aspects of embodiments related to systems, devices, and methods are described and illustrated. The embodiments and aspects are intended to be exemplary and explanatory and not limiting in scope. This application discloses a number of embodiments.
[0009] This specification is a method of attaching a mesh to a loop member. The method includes operating a wire made of a first material to form a loop member having a certain shape, applying a layer of adhesive to the loop member, placing the mesh made of a second material, at least partially covering the periphery of the loop member and having a part extending beyond the periphery of the loop member, on the loop member, exposing the adhesive to ultraviolet irradiation while holding the mesh on the loop member, adhering the mesh to the adhesive, and cutting off the part of the mesh extending beyond the periphery of the loop member. The loop member together with the attached mesh is compressible by being stored in the lumen of a sheath and deployable to the shape when extending from the sheath. A method is disclosed.
[0010] The shape of the loop can be any one of an elliptical shape, a circular shape, a teardrop shape, a rectangular shape, a square shape, or a polygonal shape.
[0011] The loop member can have a first size along a longitudinal axis passing through the center of the loop member and a second size along another axis perpendicular to the longitudinal axis and also passing through the center of the loop member. The first size can be made larger than the second size. Optionally, the first size ranges from 30 millimeters to 70 millimeters and the second size ranges from 15 millimeters to 40 millimeters. Alternatively, the first size is equal to the second size. Or, the first size is smaller than the second size.
[0012] The first material of the wire can be composed of at least one of nitinol, steel, or stainless steel.
[0013] The second material of the mesh can be composed of a polymer. Optionally, the second material of the mesh can be composed of at least one of nylon, polyethylene terephthalate, or Pebax (registered trademark).
[0014] After bonding, the mesh can have a port at the center of the loop member.
[0015] This specification discloses a recovery device comprising a loop of a flexible wire, a binder laminated on the loop of the flexible wire, and a mesh creating an opening surrounded by the loop of the flexible wire and bonded to the binder. The binder is heated to be slightly adhesive, partially moistened, or adhesive, and the outer edge of the mesh is placed on the binder, and the binder is fixedly bonded to the binder through a step of cooling the binder. The recovery device further comprises a tubular sheath including a long body, a proximal end portion, and a distal end portion, and having a lumen inside. By operating a transmission link disposed at the distal end portion of the tubular sheath, the loop of the flexible wire can be stored in the lumen together with the bonded mesh and can be extended from the lumen through an opening existing at the distal end portion of the tubular sheath.
[0016] This specification is a method for attaching a mesh to a loop member. The method includes coating a wire made of a first material with a layer made of a second material, manipulating the wire and the layer to form the loop member having a certain shape and having a first size along a longitudinal axis passing through the center of the loop member and a second size along another axis perpendicular to the longitudinal axis and also passing through the center of the loop member, placing the mesh made of a third material and at least partially covering the periphery of the loop member and having a part extending beyond the periphery of the loop member on the loop member, applying heat to the layer while holding the mesh on the loop member to partially melt the second material to make the second material sticky, slightly adhesive or partially wet, adhering the mesh together with the second material of the layer that is partially melted and sticky along the periphery of the loop member to firmly adhere upon cooling, and cutting off the part of the mesh extending beyond the periphery of the loop member. The loop member together with the attached mesh is configured to be compressible by storing it in the lumen of a sheath and expandable to the shape when extending from the sheath.
[0017] The shape of the loop member can be any one of an elliptical shape, a circular shape, a teardrop shape, a square shape, a rectangular shape, a quadrilateral shape or a polygonal shape.
[0018] Optionally, the first size is larger than the second size. Further optionally, the first size ranges from 30 millimeters to 70 millimeters and the second size ranges from 15 millimeters to 40 millimeters. Alternatively, the first size is equal to the second size. Or alternatively, the first size is smaller than the second size.
[0019] The first material of the wire can be composed of at least one of nitinol, steel, or stainless steel. Optionally, the second material of the mesh is composed of a polymer. Further optionally, the second material of the mesh is composed of at least one of nylon, Pebax, or polyethylene terephthalate.
[0020] Optionally, the third material of the mesh is composed of a polymer. Further optionally, the third material of the mesh is composed of at least one of nitinol or polyethylene terephthalate.
[0021] The layer can cover the wire.
[0022] Optionally, the layer includes a hollow tube into which the wire is inserted.
[0023] Optionally, the mesh has a shape approximating the shape of the loop member.
[0024] By heating the wire, the heat can be transferred to the second material of the layer. The wire can be electrically heated using an external power source. By heating the loop member while holding the mesh on the loop member, the heat can be transferred to the second material of the layer. Optionally, by exposing the loop member to hot air, the loop member is heated, and the hot air has a temperature within the range of 120°C to 180°C, or within the range of the melting temperature of the second material.
[0025] Optionally, the layer has a thickness in the range of 0.05 millimeters to 0.6 millimeters.
[0026] After adhesion, the mesh can have a port at the center of the loop member.
[0027] This specification is a method of attaching a mesh to a loop member. The method includes the steps of: operating a wire made of a first material to form a shaped wire; coating the shaped wire with a layer made of a second material to form the loop member; placing the mesh, made of a third material and at least partially covering the periphery of the loop member with a portion extending beyond the periphery of the loop member, on the loop member; while holding the mesh on the loop member, applying heat to the layer to partially melt the second material and make it sticky, slightly adhesive, or partially wet; partially melting the mesh and adhering it to the second material of the sticky layer; and cutting off the portion of the mesh that extends beyond the periphery of the loop member. The loop member is compressible by storing the loop member together with the attached mesh in the lumen of a sheath and deployable to a certain shape when extended from the sheath. A method is also disclosed.
[0028] The shape of the wire can be any one of an elliptical shape, a circular shape, a teardrop shape, a square shape, a rectangular shape, a quadrilateral shape, or a polygonal shape.
[0029] The loop member can have a first size along a longitudinal axis passing through the center of the loop member and a second size along another axis perpendicular to the longitudinal axis and also passing through the center of the loop member. The first size can be made larger than the second size. Optionally, the first size ranges from 30 millimeters to 70 millimeters and the second size ranges from 15 millimeters to 40 millimeters. Alternatively, the first size is equal to the second size. Or alternatively, the first size is smaller than the second size.
[0030] The first material of the wire can consist of at least one of nitinol, steel, or stainless steel.
[0031] The second material of the layer can be made of a polymer. Optionally, the second material of the layer consists of at least one of nylon, polyethylene terephthalate or Pebax.
[0032] The third material of the mesh can be made of a polymer. Optionally, the third material of the mesh is at least one of nitinol or polyethylene terephthalate.
[0033] The layer can coat the formed wire.
[0034] Optionally, the layer is a hollow tube into which the formed wire is inserted.
[0035] By heating the formed wire, heat can be transferred to the second material of the layer. Optionally, the formed wire is electrically heated using an external power source.
[0036] By heating the loop member while holding the mesh on the loop member, heat can be transferred to the second material of the layer. Optionally, the loop member is heated by exposing it to the hot air of hot gas, and the hot gas has a temperature in the range of 120°C to 180°C or within the melting temperature range of the second material.
[0037] Optionally, the layer has a thickness in the range of 0.05 millimeters to 0.6 millimeters.
[0038] After adhesion, the mesh can have a port at the center of the loop member.
[0039] This specification is a method of attaching a mesh to a loop member. The method includes covering a wire made of a first material with a layer made of a second material, manipulating the wire together with the layer to form the loop member having a certain shape and having a first size along a longitudinal axis passing through the center of the loop member and a second size along another axis perpendicular to the longitudinal axis and also passing through the center of the loop member, placing the loop member at least partially on a base fixture and holding it by a plurality of magnets received in the base fixture, where the held loop member circumscribes a hollow portion formed in the base fixture and the hollow portion is configured to receive a port-shaped fixture, holding the loop member; placing the mesh, made of a third material and at least partially covering the periphery of the loop member together with the hollow portion and having a part extending beyond the periphery of the loop member, on the loop member; pressing the mesh into the hollow portion by placing the port-shaped fixture on the mesh; transferring heat to the layer while holding the mesh on the loop member to partially melt the second material of the layer to make the second material sticky, slightly adhesive or partially wet; melting the mesh along with the partially melted second material of the layer along the periphery of the loop member and firmly adhering upon cooling; and cutting off the part of the mesh extending beyond the periphery of the loop member. A method is also disclosed where the loop member together with the attached mesh is compressible by being stored in the lumen of a sheath and deployable to the shape when extending from the sheath.
[0040] The shape of the loop member can be any one of an elliptical shape, a circular shape, a teardrop shape, a square shape, a rectangular shape, a quadrilateral shape or a polygonal shape.
[0041] The first size can be made larger than the second size. Optionally, the first size ranges from 30 millimeters to 70 millimeters, and the second size ranges from 15 millimeters to 40 millimeters. Alternatively, the first size is equal to the second size. Or alternatively, the first size is smaller than the second size.
[0042] The first material of the wire can be nitinol, steel, or stainless steel. [[ID=⑤]] [[ID=⑥]]
[0043] [[ID=⑦]] [[ID=⑧]]The second material of the layer can be made of a polymer. Optionally, the second material of the layer is nylon, Pebax, or polyethylene terephthalate. [[ID=⑨]] [[ID=⑩]]
[0044] [[ID=⑪]] [[ID=⑫]]The third material of the mesh can be made of a polymer. Optionally, the third material of the mesh is nitinol or polyethylene terephthalate. [[ID=⑬]] [[ID=⑭]]
[0045] [[ID=⑮]] [[ID=⑯]]The layer can cover the wire. [[ID=⑰]] [[ID=⑱]]
[0046] [[ID=⑲]] [[ID=⑳]]Optionally, the layer is a hollow tube into which the wire is inserted. [[ID=㉑]] [[ID=㉒]]
[0047] [[ID=㉓]] [[ID=㉔]]The mesh can have a shape approximating the shape of the loop member. [[ID=㉕]] [[ID=㉖]]
[0048] [[ID=㉗]] [[ID=㉘]]By heating the wire, heat can be transferred to the second material of the layer. Optionally, the wire is electrically heated using an external power source. [[ID=㉙]] [[ID=㉚]]
[0049] [[ID=㉛]] [[ID=㉜]]Optionally, by heating the loop member while holding the mesh on the loop member, heat is transferred to the second material of the layer. Optionally, the loop member is heated by exposing it to the hot air of hot gas, and the hot gas has a temperature in the range of 120°C to 180°C, or a temperature within the melting temperature range of the second material. [[ID=㉝]] [[ID=㉞]]
[0050] [[ID=㉟]] Optionally, the layer has a thickness in the range of 0.05 millimeters to 0.6 millimeters.
[0051] After adhesion, the mesh can have a port at the center of the loop member.
[0052] This specification is a method of attaching a mesh to a loop member, the method comprising the steps of: manipulating a wire made of a first material to form a shaped wire; covering the shaped wire with a layer made of a second material to form the loop member; placing the loop member at least partially on a base fixture and holding it by a plurality of magnets received within the base fixture, the held loop member surrounding a hollow portion formed in the base fixture between the base fixture and the loop member, the hollow portion being configured to receive a port-shaped fixture, the step of holding the loop member; placing the mesh, made of a third material and at least partially covering the perimeter of the loop member together with the hollow portion, with a portion extending beyond the perimeter of the loop member, on the loop member; placing the port-shaped fixture on the mesh and pressing the mesh into the hollow portion; applying heat to the layer while holding the mesh on the loop member to partially melt the second material, making the second material sticky, slightly adhesive or partially wet; joining the mesh with the partially melted second material of the layer; and cutting off the portion of the mesh that extends beyond the perimeter of the loop member. Also disclosed is a method wherein the loop member together with the attached mesh is compressible by being stored in the lumen of a sheath and deployable to the shape when extended from the sheath.
Brief Description of the Drawings
[0053]
Figure 1A
Figure 1B
Figure 2
Figure 3
Figure 4
Figure 5A
Figure 5B
Figure 6
Figure 7A
Figure 7B
Figure 7C
Figure 8
Figure 9
Figure 10
Figure 11
Figure 12
Figure 13
DETAILED DESCRIPTION OF THE INVENTION
[0054] The above-described and other embodiments of the present specification will be further described in greater detail with reference to the drawings and the following detailed description.
[0055] These and other configurations and advantages of the present invention will be further appreciated by referring to the following detailed description while understanding better in the context of the accompanying drawings.
[0056] Disclosed is a surgical snare or retrieval device for retrieving an object from within a human subject. The snare device is designed for use with an endoscope and can be used to retrieve a relatively heavy object within a relatively rigid lumen (e.g., to retrieve a food bolus obstructing the esophagus). When discussing the device, the terms "distal side" and "proximal side" are used with respect to the operator's hand. In other words, when the device is used within the working / service channel of an endoscope or similar device, the distal side direction and the proximal side direction are with respect to the surgeon or the operator of the device, the proximal side position represents a part of the device closer to the surgeon or the operator of the device, and the distal side position represents the distal tip of the device in the direction towards the patient.
[0057] This specification is directed to multiple embodiments. The following disclosure is provided to enable those skilled in the art to practice the present invention. The language used in this specification should not be construed as a general negation of any specific embodiment, nor should it be used to limit the scope of the claims beyond the meaning of the terms used in the claims. The general principles characterized in this specification can be applied to other embodiments and applications without departing from the spirit and scope of the present invention. Also, the technical terms and expressions are used to explain exemplary embodiments and should not be regarded as limiting. Accordingly, the present invention is in line with the broadest scope that encompasses numerous alternative means, modifications, and equivalents that are consistent with the disclosed principles and configurations. For clarity, details regarding technical items known in the technical field related to the present invention are not described in detail so as not to unnecessarily obscure the present invention.
[0058] In the specification and claims of the present application, each of the words "comprise", "include", and "have", and their forms, are not necessarily limited to the elements of the list that can be associated with the term.
[0059] As used in this specification, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly indicates a different meaning.
[0060] Note that the term "endoscope" as referred to in this specification can refer to, in particular, a colonoscope and a gastroscope according to some embodiments, but is not limited to only a colonoscope and a gastroscope. The term "endoscope" can refer to any instrument used to examine the inside of a hollow organ or cavity of the body.
[0061] Figures 1A and 1B are respectively bottom and side perspective views of the snare loop 101, while Figures 2 and 3 are respectively a perspective view and a longitudinal cross-sectional view of the target capture and recovery snare device 100 according to the embodiments of the present specification. Referring now to Figures 1A, 1B, 2, and 3, the snare loop 101 includes a flexible and stretchable coated loop member 105 (hereinafter also interchangeably referred to as a "loop"), and a mesh or net 110 is detachably and removably but firmly attached or connected to the loop member 105. As will be discussed below with reference to Figure 3, since the wire of the loop 105 is coated or wrapped by a binder, the loop member 105 is described as "coated". The snare device 100 includes a tubular member or sheath 115 having a long body with a proximal end 115a and a distal end 115b, and a conduit or lumen 120 that can recoverably store the coated loop member 105 to which the mesh or net 110 is attached in a fully compressed (collapsed) and stored posture as shown in Figure 3.
[0062] In one embodiment, the mesh or net 110 is formed by a process of wrapping and braiding a plurality of strands of a polymeric material such as, for example, nylon or PET (polyethylene terephthalate) or other polymers described hereinafter in this specification (but not limited thereto). And the tubular member or sheath 115 is made of an insulating flexible material including high-density polyethylene (HDPE), tetrafluoroethylene (TFE) resin, or a polytetrafluoroethylene (PTFE) polymer such as Teflon (registered trademark) or Fluon (registered trademark). According to one embodiment, the polymeric material of the mesh, net or web 110 has elastomeric properties, and the polymeric material advances, elongates or stretches by at least 10% to 40% in the machine direction (MD) and at least 20% to 70% in the cross machine direction (CMD). Those skilled in the art can understand that the term "machine direction (MD)" used in this specification refers to the direction in which the material flows through the process, while the term "cross machine direction (CMD)" used in this specification refers to the direction generally perpendicular to the longitudinal direction. In various embodiments, the mesh 110 is 1 cm 2It has porosity with holes in the range of 15 to 40 per unit area. In certain embodiments, the thickness of the polymeric material forming the mesh or net 110 ranges from 0.05 mm to 0.3 mm. Alternatively, the mesh or net 110 can be a continuous film or web of polymeric material. Also, in various embodiments, the mesh, net or web 110 can be made fine or non-uniform. According to certain embodiments, the mesh, net or web 110 includes a pouch or bend 145 to which a mesh 110 having a covering loop member 105 is adhered.
[0063] The sheath 115 has a distal opening 122 that communicates with the lumen 120. Through the distal opening 122, the covering loop member 105 can be partially or fully extended for deployment and can be partially or fully retracted for storage. In one embodiment, the deployment of the covering loop member 105 from the lumen 120 of the sheath and the retraction of the covering loop member 105 into the lumen 120 of the sheath are performed using a motion transfer link 170 that is connected to the proximal end 107 of the covering loop member 105 through the proximal opening 124 of the sheath 115. In various embodiments, the motion transfer link 170 is a hollow tube of a suitable rigid material (such as stainless steel), a twisted strand wire or a braided wire. When the operator pulls the link 170 out of the proximal opening 124, the covering loop member 105 is retracted into the sheath 115, while when the operator pushes the link 170 into the proximal opening 124, the covering loop member 105 extends beyond the distal opening 122 of the sheath 115.
[0064] As shown in FIG. 2, the sheath 115 extends in the distal direction from the distal end side portion 196a of the handle assembly 196. In one embodiment, the length of the sheath 115 closest to the distal end side portion 196a of the handle assembly 196 includes the strain relief 197 of the shaft. The strain relief 197 of the shaft covers the sheath 115 and relieves the strain on the rigid motion transmission link 170 (shown in FIG. 3) when the motion transmission link 170 advances into the sheath to deploy the snare loop. The strain relief 197 of the shaft ensures smooth movement of the motion transmission link 170 and promotes proper deployment of the snare loop.
[0065] FIG. 4 is a schematic cross-sectional view of the covered loop member 105 of the target capture and recovery device manufactured according to the aspects of the present specification. Referring now to FIGS. 1A, 1B, 2, 3, and 4, the wire 130 having a diameter of “d” present in the core of the covered loop member 105 is composed of an elastic, durable, and conductive material suitable for forming a desired loop shape. According to one embodiment, the diameter “d” of the wire 130 ranges from 0.2 millimeters to 0.6 millimeters. When the covered loop member 105 extends from a compressed or contracted posture (FIG. 3) within the tubular member or sheath 115 (FIGS. 1A, 1B, and 2), the covered loop member 105 automatically deploys to maintain a desired loop shape configuration, thereby providing an opening for the attached mesh or net 110. Similarly, when the covered loop member 105 is stored within the tubular member or sheath 115, the covered loop member 105 contracts together with the attached mesh or net 110 and is compressed within the lumen 120 of the sheath. In various embodiments, the wire 130 is made of braided steel, a metal shape memory alloy (such as Nitinol), or any other suitable flexible material that is a conductor of heat and electricity and is sufficiently elastic to maintain the desired loop shape upon deployment.
[0066] In one embodiment, the desired shape of the wire 130 upon deployment, and thus the desired shape of the covered loop member 105 upon deployment, is a teardrop shape (as represented in FIG. 6 showing the covered loop member 105 with the mesh / net removed). On the other hand, in an alternative embodiment, the desired shape upon deployment is an elliptical shape (FIGS. 1A, 1B), circular shape, square shape, rectangular shape, quadrilateral shape, polygonal shape, or any other suitable shape that would be apparent to one of ordinary skill in the art as advantageous. Referring to FIG. 1A, in one embodiment for describing an elliptical or teardrop shape, the loop has a first size L1 along a longitudinal axis 150 passing through the reference center 155 of the loop, and a second size L2 along another axis 165 that is substantially perpendicular to the longitudinal axis 150 and also passes through the reference center 155 of the loop. In various embodiments, the first size L1 is greater than the second size L2. In one embodiment, the first size L1 is equal to the second size L2. In still other embodiments, the first size L1 is less than the second size L2. In accordance with various embodiments, when the desired shape of the wire 130 is a teardrop or elliptical shape, the range of the first size L1 is from 30 millimeters to 70 millimeters, and the range of the second size L1 is from 15 millimeters to 40 millimeters.
[0067] Referring again to FIG. 4, according to an aspect of the present specification, wire 130 is coated or encapsulated by layer 135 composed of a polymeric material having a thickness “t” and functioning as an “adhesive adhesive” in one embodiment. As used herein, the term “adhesive adhesive” is defined to mean a material that can be changed (or partially melted) by applying heat or a solvent to become sufficiently adhesive or tacky and that adheres strongly to other polymeric materials and / or metals upon cooling. The “adhesive adhesive” can adhere the mesh to the loop in these contact areas and can provide a strong connection after the adhesive has cooled. For the purposes of the present specification, tackiness is defined as having slight tack characteristics or being partially wet or not completely dry. The polymeric material becomes thermoplastic when heated to a temperature below its decomposition temperature or ignition temperature, has sufficient tackiness or tack characteristics, and adheres to similar or dissimilar surfaces (such as metals). Examples of polymeric materials include polyolefins, polyethylene terephthalate (PET), polyurethanes, polynorbornenes, polyethers, polyacrylates, polyamides (polyether block amides also called Pebax), polysiloxanes, polyether amides, polyether esters, trans-polyisoprene, polymethyl acrylate (PMMA), cross-linked trans-polyethylene, cross-linked polyethylene, cross-linked polyisoprene, cross-linked polycyclooctene, inorganic-organic hybrid polymers, copolymer blends including polyethylene and Clariant® (registered trademark), styrene-butadiene copolymers, urethane-butadiene copolymers, polycaprolactone or oligocaprolactone copolymers, polylactic acid (PLLA) or polylactide (PL / DLA) copolymers, polylactic acid-polyglycolic acid (PGA) copolymers, and photocrosslinkable copolymers.
[0068] In one embodiment, the polymeric material of layer 135 is nylon or Pebax. In one embodiment, layer 135 is formed by coating wire 130 with a polymeric material (such as Pebax) using conventional methods (such as extrusion, overmolding, or dipping). In other embodiments, layer 135 is a hollow tube of polymeric material (such as Pebax), wire 130 is inserted into the hollow tube, and the hollow tube wraps or coats wire 130 like a sheath. In one embodiment, layer 135 in the form of a hollow tube has an inner diameter in the range of 0.3 millimeters to 1.0 millimeter and an outer diameter in the range of 0.5 millimeters to 1.50 millimeters. In various embodiments, the thickness "t" of the coating of polymeric material (such as Pebax) or layer 135 in the form of a hollow tube is in the range of 0.05 millimeters to 0.6 millimeters.
[0069] Figure 5A represents an embodiment of a snare loop 101a in which layer 135 (in the form of a coating or a hollow tube) continuously wraps or covers wire 130. In an alternative embodiment, as shown as snare loop 101b in Figure 5B, layer 135 is divided into a plurality of segments, and a plurality of portions 130' of wire 130 remain exposed or without a coating or hollow tube (layer 135). This discontinuous or segmented layer 135 provides a more flexible mesh 110 that deforms when the snare loop 101 expands or contracts. According to one aspect, layer 135 (in the form of a coating or a hollow tube) has a light color (such as, but not limited to, blue, green, red). The light color of layer 135 can improve the visibility of the boundaries of the loop during (such as during an endoscopic procedure) when loop 101 is in fluid communication with body fluid.
[0070] In one embodiment, during the process of manufacturing or assembling the snare loop 101 of this specification, first the wire 130 is bent or folded into a desired loop shape, and then the wire 130 is coated or wrapped with the layer 135. However, in an alternative embodiment, first the wire 130 is coated or wrapped with the layer 135, and then the wire 130 is bent or folded into a desired loop shape. In some embodiments, as shown in FIG. 7A, the wire 130 that has already been bent or folded into the desired loop shape includes a fastener, string or clip 140 at the proximal end of the loop 105. In various embodiments, the fastener, string or clip 140 includes at least one joint, hypodermic tube, at least one clip or any other fixture, and joins the proximal arms 141, 142 generated by bending the wire 130 into the loop 105. However, in embodiments where it is necessary to wrap the wire 130 inside the hollow tube 135, the fastener, string or clip 140 becomes an obstacle. Therefore, in one embodiment, the fastener 140 (for example, at least one joint) is cut without damaging the wire 130 and while maintaining a smooth cut region or cut surface. As shown in FIG. 7B, an inappropriately or carelessly cut fastener or string (for example, a joint) has a wavy or jagged surface 143, while as shown in FIG. 7C, an appropriately cut fastener or string (for example, a joint) has a smooth surface 143'. In various embodiments, the internal channels of the wire 130 and / or the hollow tube 135 can be coated with a dry lubricant to reduce friction during the process of wrapping the wire 130 inside the hollow tube 135. Non-limiting examples of dry lubricants include powders of PTFE (polytetrafluoroethylene), McLube or silicone oil, etc. However, in certain embodiments, the wire 130 is bent or folded into the desired shape without providing a joint point. In such embodiments, it is easily achieved to wrap the wire 130 inside the hollow tube 135.
[0071] Referring simultaneously to FIGS. 1A, 1B, 2-4, 5A and 5B and FIGS. 7A, 7B, 7C and 8-12, according to an embodiment of the present specification, in order to attach the mesh or net 110 to the covering loop member 105, the mesh or net 110 is placed and held on the covering loop member 105, and the wire 130 is heated. The shape of the mesh 110 approximates the shape of the covering loop member 105. Also, the dimensions of the mesh 110 are selected such that a portion of the mesh 110 extends beyond the perimeter along the edge of the covering loop member 105 where the mesh 110 is located below. In one embodiment, the mesh 110 has an intentional sag while being placed on the covering loop member 105. Due to this sag, after attaching or connecting the mesh 110 to the covering loop member 105, a pouch 145 is preferably formed at the center 155 of the covering loop member 105.
[0072] FIG. 8 shows an embodiment of a base fixture 175 used to attach the mesh 110 to the covering loop member 105. The base fixture 175 includes a loop holding region 176 on its upper surface 177 that approximates the shape of the covering loop member 105. In one embodiment, the loop holding region 176 includes a plurality of magnets 178 that firmly hold the covering loop member 105 in place after the covering loop member 105 is placed on the loop holding region 176. The loop holding region 176 defines a hollow portion formed between the loop holding region 176 of the base fixture 175 and the covering loop member 105. This hollow portion is configured to receive a pouch-shaped fixture 180 therein.
[0073] For assembly, the coated loop member 105 is placed over the loop retaining area 176 and a plurality of magnets 178 firmly hold the coated loop member 105. In one embodiment, the plurality of magnets 178 are embedded in the base fixture 175 and are located generally along the perimeter or boundary defined by the loop retaining area 176. Next, the mesh 110 is placed over the retained coated loop member 105. Here, the mesh 110 covers the coated loop member 105 such that portions along the edges of the mesh 110 extend beyond the perimeter of the underlying coated loop member 105. Thereafter, the mesh 110 is positioned, pressed or forced into the cavity by placing the port-shaped fixture 180 over the portion of the mesh 110 located over the cavity. Pressing of this mesh 110 fills the cavity and forms the port 145 (shown in FIG. 1B). In some aspects, the mesh 110 is held in place by at least the weight of the port-shaped fixture 180. A plurality of guide pin holes 182 can guide corresponding guide pins to be inserted into the guide pin holes 182 to align, hold and / or maintain the mesh 110, loop 105 and port-shaped fixture 180 together.
[0074] To attach and connect the mesh 110 to the covering loop member 105, the wire 130 is heated to an appropriate temperature to partially melt, soften, and make sufficiently sticky or adhesive a layer 135 of a polymeric material (such as nylon or Pebax, etc.) without burning or decomposing it. This appropriate temperature depends at least on the specific polymeric material used. In one embodiment, heat is transferred to the layer 135 by electrically heating the wire 130 using an external electrical circuit / power source. In an alternative embodiment, heat is transferred to the layer 135 by blowing hot air onto the covering loop member 105 while firmly holding the mesh 110 located above it on the covering loop member 105. In various embodiments, the temperature of the hot air is in the range of 120°C to 180°C, or within the melting temperature range of the binder. As shown in FIG. 9, in still other embodiments, a soldering iron, a heat press 185 (or any other heat source obvious to those skilled in the art) is used to solder, heat press, or thermally weld the mesh 110 along an edge located above the periphery of the covering loop member 105 to transfer heat to the layer 135. As a result, a plurality of polymeric strands (such as nylon or PET strands) of the mesh 110 are adhered to the loop wire by the adhesive or adhesive layer 135, and thus a strong adhesion is formed upon cooling.
[0075] When firmly adhering the mesh 110 to the layer 135 (and thus to the coated loop member 105), as shown in FIG. 10, a portion 186 of the mesh 110 that extends beyond the perimeter of the coated loop member 105 is cut or trimmed to remove the loose end or portion 186 (also referred to as the "extending portion"). In one embodiment, as shown in FIG. 10, a laser beam 187 is used to cut or trim the extending portion 186. In an alternative embodiment, as shown in FIG. 11, a mesh cutting die 190 is used. As shown, the assembled, adhered, or fused mesh 110 and coated loop member 105 (hereinafter also referred to as the "adhesive assembly") are positioned and aligned between guide or alignment pins 192 and 194. The shape of the cutting die 190 approximates the shape of the loop member 105 and also has a hollow portion 195 that surrounds the port 145 formed when the die 190 is pressed onto the "adhesive assembly". By pressing or pressing the die 190 onto the "adhesive assembly", the extending portion 186 is cut or trimmed. When the cutting die 190 is pressed onto the "adhesive assembly", the mating hole 192' receives the alignment pin 192, enabling proper alignment of the die 190 with the "adhesive assembly", thereby allowing the extending portion 186 to be accurately cut or trimmed. In yet another embodiment, ultrasonic welding is used to cut or trim the extending portion 186. Heat is generated by the ultrasonic welding to melt the area of the mesh to cut the area.
[0076] As shown in FIG. 12, according to one embodiment, the portion of the mesh 110 that extends over the proximal length 198 of the loop 105 is fused or adhered to the corresponding portion of the layer 135 along the proximal length 198. After cutting or trimming the extending portion 186 (shown in FIGS. 10 and 11), the proximal length 198 retains the melted portion of the mesh 110 that forms a shrink tube over the proximal length 198, thereby holding the proximal length 198 and the melted portion of the mesh 110 together and sufficiently reinforcing the proximal arms 141, 142 (visible in FIG. 7A).
[0077] According to an alternative embodiment of the present specification, the mesh 110 is directly adhered to the wire 130 to eliminate the layer 135. In such an embodiment, the mesh 130 is adhered to the wire 130 using an adhesive that is then dried, ultraviolet welding, laser welding, thermal welding, thermal staking, or any other method known to those skilled in the art. In one embodiment, an ultraviolet (UV) curable adhesive is used to directly adhere the mesh 110 to the wire 130 (eliminating the need for the layer 135) in a curing process that accelerates the curing or drying of the adhesive by using high-intensity ultraviolet light or ultraviolet irradiation (by exposing or irradiating the adhesive with ultraviolet irradiation). An example of an ultraviolet curable adhesive is Loctite®, a brand of adhesives sold by Henkel.
[0078] In use, a tubular member or sheath 115 having a flexible and stretchable covered loop member 105 compressed therein is inserted through the working or service channel of an endoscope and positioned near a target (such as a polyp in a body lumen, detached human tissue, foreign object, or obstructed food bolus, etc.). When attempting to capture the target, the covered loop member 105 extends out of the tubular member or sheath 115 and automatically deploys in this process, thereby providing an opening to the attached mesh 110 and thus the port 145. In one embodiment, when the target is captured by the mesh 110, the covered loop member 105 is partially retracted to secure the target within the mesh portion 110. In other embodiments, when the target is captured by the mesh 110, the recovery device and the target are removed from the patient without retracting the covered loop member 105 into the sheath 115. In one embodiment, the presence of the port further serves to hold the target firmly.
[0079] Figure 13 is a flowchart showing exemplary steps of a method of forming a coated loop member and attaching, adhering, or connecting a mesh or net to the coated loop member in accordance with various embodiments of the present specification. In step 1310, a wire is obtained. The wire has a diameter “d” and is made of braided steel, stainless steel, nitinol, or any other shape memory alloy known to those skilled in the art. In one embodiment, in step 1315a, the wire is coated or encapsulated with a layer of a polymeric material (such as, but not limited to, nitinol or Pebax) having a thickness “t”. The layer can be formed by coating the wire with the polymeric material or inserting the wire into a hollow tube of the polymeric material. In step 1320a, the wire coated or encapsulated with the layer of the polymeric material is then manipulated (e.g., by bending or folding) into a loop of a desired shape or dimension to form a coated loop member. In other embodiments, in step 1315b, the wire is first manipulated (e.g., by bending or folding) into a loop of a desired shape and dimension. Then in step 1320b, the wire of the formed loop is coated or encapsulated with a layer of the polymeric material to form a coated loop member.
[0080] In some embodiments, the wire first bent or folded into a desired loop shape in step 1315b includes a fastener, cord, or clip at the proximal end of the loop and holds together the proximal arms created by bending the wire. In various embodiments, the fastener, cord, or clip comprises at least one fitting, hypo tube, at least one clip, or any other attachment means apparent to those skilled in the art. In such embodiments, the fastener (such as at least one fitting, etc.) is first cut or removed before step 1320b of coating or encapsulating the wire with a layer of the polymeric material (a hollow tube in one embodiment) to form a coated loop member.
[0081] In various embodiments, the desired shape of the loop is elliptical, circular, teardrop-shaped, square-shaped, rectangular, quadrilateral, or polygonal. In one embodiment, the loop has a first size along a longitudinal axis passing through the center of the coated loop member and a second size along another axis perpendicular to the longitudinal axis and also passing through the center of the coated loop member. In various embodiments, the first size is greater than the second size. In certain embodiments, the first size is equal to the second size. In still other embodiments, the first size is less than the second size. It should be understood that the coated loop member is formed using step 1315a and subsequent step 1320a, or using step 1315b and subsequent step 1320b.
[0082] Next, in step 1325, a mesh, web, or net of a polymeric material (such as, but not limited to, nylon, polyethylene terephthalate) is obtained. The shape of the mesh approximates the shape of the coated loop member, and the dimensions of the mesh are somewhat larger than the dimensions of the coated loop member. In step 1330, the coated loop member is placed on a base fixture having a plurality of magnets to hold the coated loop member in a fixed position. Then, the mesh or net is placed or held over the coated loop member such that a portion of the mesh along the edge of the coated loop member extends beyond the perimeter of the coated loop member. In certain embodiments, the mesh partially covers the perimeter of the coated loop member. In other embodiments, the mesh completely covers the perimeter of the coated loop member. In one embodiment, a port-shaped fixing portion is used to press or push a portion of the mesh covering the center of the coated loop member into a hollow portion defined in the base fixture, such that the mesh is held in a fixed position at least by the weight of the port-shaped fixing portion. Thereby, while the mesh is being placed over the coated loop member, an intentional sag is imparted to the mesh. Due to this sag, after the mesh is connected to the coated loop member, a port is formed at the center of the coated loop member.
[0083] Next, in step 1335, heat is transferred to the layer of polymeric material. In one embodiment, the wire of the coating loop member is heated to an appropriate temperature that partially melts, softens, and provides sufficient tackiness, slight adhesiveness, or partial wetting of the layer of polymeric material without burning or decomposing it. For example, heat can be transferred to the polymeric material layer using an external electrical circuit or power source to electrically heat the underlying wire, by exposing the coating loop member to hot air (while blowing hot air onto both the coating loop member and the mesh and firmly holding the mesh placed on the loop in a fixed position), by applying a soldering iron, by thermally pressing around the coating loop member that exists above the mesh along the mesh boundary from above the mesh, or by any other method that may be found advantageous by those skilled in the art (but not limited to these). As a result, in step 1340, a plurality of strands of the mesh located on the surface around the coating loop member fuse with or adhere to the adhesive layer or adhesive using an adhesive and adhere firmly to the coating loop member upon cooling. Finally, in step 1345, the portion of the adhered mesh that extends beyond the perimeter of the coating loop member is cut or trimmed using a laser beam, ultrasonic welding, or a mesh cutting die. Loose ends or strands that extend beyond the coating loop member can potentially damage or harm surrounding tissue when used in endoscopic procedures, but the above methods ensure the elimination of such loose ends or strands.
[0084] The above examples are merely illustrative of a number of applications of the methods and systems described herein. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention can be embodied in many other specific forms without departing from the spirit or scope of the present invention. Accordingly, these examples and embodiments are considered illustrative and not restrictive, and the present invention can be modified within the scope of the appended claims.
Claims
1. A wire loop having a first side portion and a second side portion, wherein the first side portion faces a direction opposite to the direction in which the second side portion faces; An adhesive material laminated on the wire loop and including a first portion on the first side portion of the wire loop and a second portion on the second side portion of the wire loop; A mesh bonded to the adhesive material and having an opening surrounded by the wire loop, the mesh being bonded to the first portion rather than the second portion; The mesh includes a plurality of strands surrounding a plurality of holes, and some portions of the plurality of strands are bonded to the first portion of the adhesive material along the outer periphery of the mesh. The mesh has 15 to 40 holes per 1 cm2. A recovery device.
2. The mesh is fixedly bonded to the adhesive material by a process of heating the adhesive material to an adhesive state, disposing an outer edge of the mesh on the adhesive material while the adhesive material is in the adhesive state, and cooling the adhesive material. The recovery device according to claim 1.
3. The recovery device further includes a sheath, and the sheath includes A lumen; A proximal end; A distal end; A distal opening, the lumen extends between the proximal end and the distal end, and the lumen communicates with the distal opening; The recovery device includes a driving element extending through the lumen of the sheath to the wire loop. The driving element moves within the lumen of the sheath to Move at least a part of the wire loop and at least a part of the mesh outward from the distal opening of the sheath to the distal side, and The recovery device according to claim 1, configured to move at least the part of the wire loop and at least the part of the mesh toward the proximal side into the distal opening of the sheath.
4. Some of the plurality of strands remain fixed to the material layer when the wire loop and the mesh move through the distal opening of the sheath. The recovery device according to claim 3.
5. The wire of the wire loop is bisected into the first side portion and the second side portion by a bisecting plane, and the bisecting plane at least partially extends in a plane on which the wire loop lies. The recovery device according to claim 1.
6. The wire loop is made of at least one of nitinol, steel, or stainless steel, and the mesh is made of at least one of nylon or polyethylene terephthalate (PET). The recovery device according to claim 1.
7. The recovery device according to claim 1, wherein the mesh has a port at the center of the wire loop.
8. The recovery device according to claim 1, wherein the shape of the wire loop is any one of an elliptical shape, a circular shape, a teardrop shape, a square shape, a rectangular shape, a quadrangular shape, and a polygonal shape.
Citation Information
Patent Citations
Improved snare ablation surgical instrument assembly and method of manufacture
JP2000513616A
Recovery device
JP2010528785A
Surgical retrieval device and method using a semi-rigid, expandable, and foldable basket
JP2014527849A
JPP6634440B
JPP7139306B