Braided hemostatic shaft for improved torsional response

Abstract

A medical insertion device (100) includes an elongated shaft (101) extending from a proximal end to a distal end and having sufficient flexibility to be inserted through a working channel of an endoscope along a tortuous path. The elongated shaft includes a coil (102) extending from the proximal end to the distal end and having a channel (106) extending longitudinally therethrough, and a braided portion (110) extending around the coiled portion, the braided portion including a plurality of wires (112, 114) wound together such that a first (112) and a second (114) wire intersect to enclose a preset angle therebetween, the angle being between 25 and 55 degrees.

Description

[0001] priority

[0002] The present invention claims the benefit of U.S. Provisional Application No. 61 / 867,935, filed on August 20, 2013. The entire description of the above application is incorporated herein by reference. Background Art

[0003] Conditions of the gastrointestinal tract ("GI"), biliary tract, vascular system and other body cavities are generally treated by endoscopic surgery, many of which require active and / or preventive hemostasis to control internal bleeding. Tools that place hemostats through an endoscope are often used to clamp the edges of a wound or incision together to control internal bleeding. These tools are inserted into the body through the working channel of the endoscope. Specifically, these tools can be attached to an elongated coil that is inserted through the endoscope to provide the flexibility required to allow insertion through a tortuous path in the body. However, the elongated coil often fails to provide sufficient torsional stiffness to transfer the required rotation applied to the proximal end of the coil (e.g., at the proximal handle) to a hemostatic device (e.g., forceps, etc.) connected to the distal end of the coil. Specifically, because the coil compresses or expands when subjected to a torsional load until the outer diameter of the spring is subjected to a reaction force, much of the energy input to the coil is dissipated before being transferred to the distal end of the coil. Therefore, most of the rotation applied to the proximal end of the spiral only results in expansion / compression of the coil, and the corresponding rotation cannot be transferred to the distal end of the spiral. Summary of the invention

[0004] The present invention relates to a medical insertion device, the medical insertion device comprising an elongated shaft extending from a proximal end to a distal end and having sufficient flexibility to be inserted through an endoscope working channel along a tortuous path. The elongated shaft comprises a coil extending from the proximal end to the distal end and having a channel extending longitudinally therethrough, and a braided portion extending around the coiled portion, the braided portion comprising a plurality of wires wound together, so that the first and second wires intersect to enclose a preset angle between them, the angle being between 25 and 55 degrees. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 A perspective view of a shaft according to a first exemplary embodiment of the present invention is shown;

[0006] Figure 2 A perspective view of a shaft showing a first alternative embodiment of the present invention;

[0007] Figure 3 shows a perspective view of a shaft according to a second alternative embodiment of the present invention;

[0008] Figure 4 A perspective view of a shaft showing a third alternative embodiment of the present invention;

[0009] Figure 5 shows a perspective view of a shaft according to a fourth alternative embodiment of the present invention;

[0010] Figure 6 shows a perspective view of a shaft according to a fifth alternative embodiment of the present invention;

[0011] Figure 7 shows a perspective view of a shaft according to a sixth alternative embodiment of the present invention;

[0012] Figure 8 Shown is a Figure 1 a perspective view of an exemplary shaft clamping device;

[0013] Fig. 9 Shows Figure 8 Partial cross-sectional view of the clamping device. DETAILED DESCRIPTION

[0014] The present invention may be better understood with reference to the following description and accompanying drawings, wherein like reference numerals represent similar elements. The present invention relates to a flexible shaft that allows rotation applied to the proximal end of the shaft to be transmitted as a corresponding rotation of the distal end of the shaft, such that the rotation can affect a device connected to the distal end of the shaft when the device is inserted into the body along a tortuous path, for example, to perform hemostasis. However, it should be noted that an exemplary shaft according to the present invention can be used with any device used to perform endoscopic surgery, including but not limited to, banding, injection therapy, thermoelectric hemostasis, combination therapy needles, biopsies, fine needle aspiration, and therapeutic procedures of the upper and lower gastrointestinal tract ("GI"). As will be described in more detail below, an exemplary shaft according to the present invention includes an elongated pre-wound coil having a predetermined diameter, length, number of turns, etc. As will also be described in more detail subsequently below, the shaft further includes a braided element wound around the coil, the braided element being a predetermined plurality of wires wound together in a predetermined pattern relative to each other. The angle at which the wires are braided can be selected to be within 25-55 degrees, including the endpoints. As will be described in more detail below, this range provides the shaft with the desired torsional stability to impart rotation to a device connected to the distal end of the shaft, while still allowing the shaft to be flexible to permit insertion through tortuous anatomical structures. It should be noted that the terms "proximally" and "distally", as used herein, are intended to indicate directly toward (proximally) a user of the device and away from (distally) a user of the device.

[0015] like Figure 1As shown, a device 100 according to an exemplary embodiment of the present invention includes an elongated body 101 extending longitudinally from a proximal end (not shown) to a distal end (not shown), wherein the proximal end is in an operational form that can be contacted by a physician or other user, and the distal end, in use, is inserted into a living body to a position adjacent to a target tissue. As can be appreciated by those skilled in the art, the device includes a first portion 102 formed as a coil, wherein the coil includes an elongated wire or filament 104 wound into a coil-shaped configuration and has a preset elastic constant. The size of the first portion 102 is determined to allow it to be inserted into a working channel (not shown) of an endoscope (for example, the outer diameter of the device 100 is smaller than the inner diameter of the operating channel). A cavity 106 extends through the device along a longitudinal axis 108 of the device 100. In an exemplary embodiment, the first portion 102 is formed by winding a coil. Figure 1 The first portion 102 is formed of a single wire or filament 104 of a structure. However, it should be noted that any number of wires 104 and any arrangement of the wires 104 may be used without exceeding the scope of the present invention. For example, the first portion 102 may include a plurality of coils arranged to overlap each other, each coil being wound in a direction opposite to that of an adjacent coil.

[0016] The second portion 110 of the device 100 presents a braided exterior that envelops the first portion 102. The second portion 110 comprises a plurality of wires or threads 112 wound together on the coil-shaped first portion 102 in a braided manner. Figure 1 The exemplary embodiment of the present invention shows eight wires or carriers 112. However, it should be noted that any number of wires may be used without exceeding the scope of the present invention. In the exemplary embodiment, each wire 112 includes four individual strands 114, so that a total of 32 strands form the second portion 110. However, it should be noted that each wire 112 may include any number of wires without exceeding the scope of the present invention, wherein the number of wires used may depend on the outer diameter of each wire 114. As will be described in more detail below, for example, each wire 112 may include one, two, three, four, five or more strands 114.

[0017] In addition, each wire 112 may include a different number of individual strands 114 to affect the overall stiffness of the second portion 110 and thus the device 100, as will be appreciated by those skilled in the art and will also be described in more detail in subsequent embodiments. In another embodiment, the braided second portion 110 may be unbalanced in order to simulate a double coil formed by counter-winding wires, as will be appreciated by those skilled in the art. For example, the braided second portion 110 may include a first wire 112, and a second wire 112 wound therewith, the first wire being composed of one or more strands 114 having a first diameter, and the second wire being composed of one or more strands 114 having a second diameter different from the first diameter. In an exemplary embodiment, the diameters of the plurality of individual strands 114 forming the wire 112 are substantially the same. The strands 114 according to this exemplary embodiment have a substantially circular cross-section, although any other cross-section shape, including but not limited to rectangular and elliptical, may be used without exceeding the scope of the present invention.

[0018] The threads 112 are braided relative to each other at a predetermined braiding angle. Figure 1 As shown in , the wires 112 intersect each other at the intersection 116. Multiple portions of the wires 112 extending from each intersection constitute an angle α. In a first exemplary embodiment, the angle α is 40.5°. In another exemplary embodiment, the angle α is 37.5°. Still in another exemplary embodiment, the angle α can be any angle between 25°-55° including the endpoints. In order to provide a proper balance between the bending and torsional stiffness of the device 100 so that it can perform operations in a tortuous path, an exemplary braiding angle α can be selected. Specifically, the present invention determines that a braiding angle of about 55° or more increases the bending stiffness to a level higher than the bending stiffness suitable for bending through a tortuous path. The present invention further determines that when the device 100 is bent along a tortuous path, a braiding angle of less than 25° cannot provide sufficient torsional stiffness to transfer rotation along the coil. An exemplary range according to the present invention provides a balance of torsional stiffness and rotation transfer to allow the device 100 to be inserted through a tortuous path while transferring the rotation applied to the proximal end of the coil along the coil to its distal end. However, in applications where low tortuosity is encountered, a braid angle = 55° may be used. Likewise, in applications where high tortuosity is encountered, a braid angle = 25° may be used.

[0019] It should be noted that although Figure 1The embodiment depicts that the braiding angle α is the same over the entire length of the device 100, but the braiding angle α can be modified in different parts of the device 100 without exceeding the scope of the present invention. Although it is not suitable to use a braiding angle less than 25° or greater than 55° for most of the length of these coils, a small portion of the coil that requires additional flexibility or increased stiffness can be formed by a braiding angle outside the range. For example, a first section length of the second portion 110 adjacent to the distal tip of the device 100 can be formed by a braiding angle α less than 25° to increase flexibility, and the first section has a high warp density. The length of the first section depends on the specific application (e.g., the tortuosity of the target anatomical structure). When the tortuosity of the anatomical structure increases, the deflection ability of the first section decreases to achieve the desired torsional / rotational performance. In another embodiment, instead of setting the first section to have a braiding angle α less than 25°, the braid can be omitted in this area to further increase the flexibility of the first section 102. In an exemplary embodiment, the first section can extend to 15.24cm from the distal end of the first section 102. Likewise, when additional stiffness is desired, the second segment of the second portion 110 can be formed with a braid angle α greater than 55°. Similar to the first segment, the length of the second segment depends on the tortuosity of the target anatomical structure and other factors, including, but not limited to, the length of the first portion 102 remaining outside the endoscope during the procedure, the stroke length required for the procedure of inserting the working channel of the endoscope, etc. For example, when used with an upper gastrointestinal (GI) endoscope, the length of the second segment can be larger because the distance between the proximal handle of the endoscope and the endoscope entrance is relatively large when compared to procedures performed on other parts of the anatomical structure. In another embodiment, the second segment can be positioned near the proximal end of the second portion so that it remains outside of any tortuous anatomical structure in an operational state.

[0020] The torsional stability and bending stiffness of the second braided portion 110 can also be modified by changing its warp density. The warp density refers to the number of braid intersections formed per unit length of the coil. In an exemplary embodiment, as Figure 1 As shown in , the warp density can include 17 intersections per unit length of 10 mm. However, it should be noted that any other warp density can be used without exceeding the scope of the present invention. As can be appreciated by those skilled in the art, the warp density varies according to the number of individual wires 114 forming the woven second portion 110, the number of lines 112, and the type of weaving pattern selected.

[0021] The braided second portion 110, exemplified in the exemplary embodiment, is formed of a biocompatible material (e.g., stainless steel, or other biocompatible metals and alloys), a biocompatible polymer, a plastic coated guide wire, or a hybrid material. In one embodiment, each individual strand 114 is formed with a plastic coating that can be reflowed (e.g., by heating) to lock the braided second portion 110 in a desired configuration. The proximal and distal ends of the braided second portion 110 can be tapered to seamlessly fit the first portion 102. This taper can be formed with the wire 112 or can be machined after braiding (e.g., by grinding, etc.).

[0022] The device 100 can be formed such that the first portion 102 includes a reduced diameter portion 105 at its distal end. As can be appreciated by those skilled in the art, this configuration increases the flexibility of the distal end of the device, for example to assist the device 100 in passing through a tortuous path in the body. The reduced diameter portion 105 can be provided in more than one place, including the distal end of the body 101, the proximal end of the body, or any position in between. In an exemplary embodiment, the reduced diameter portion 105 is ground to have a smaller diameter than the peripheral portion of the first portion 102. It should be noted that since the reduced diameter portion 105 increases flexibility, the portion may not include a second portion 110 extending thereon. In such an embodiment, the second portion may terminate at a position close to the reduced diameter portion 105. The diameter of the terminal end of the wire 112 including the second portion 110 may be tapered to prevent damage to the working channel of the endoscope. In another embodiment, the first portion 102 has the same diameter along its length, and the proximal end of the second portion 110 terminates at the distal end of the first portion 102 to increase flexibility at the distal end. In yet another embodiment, the first portion 102 may be equipped with a plurality of second portions 110 along its length, the plurality of second portions 110 being separated from one another to define regions of increased flexibility along the length of the device 100 .

[0023] like Figure 8As shown in , the exemplary device 100 can be used in a clamping device 800. The clamping device 800 includes a cylindrical capsule 810 that can be releasably connected to the distal end of the elongated body 101 of the device 100. As described in more detail above, the outer diameter of the second portion 110 of the device 100 can be tapered toward the distal end of the elongated body 101. The capsule 810 accommodates the proximal end of a single hemostat 812. The forceps 812 are connected to a proximal actuation handle 816 that remains outside the body by a control guide wire 814, and the forceps 812 include a pair of tissue clamping arms 818 that bring separated tissue parts together (e.g., close a wound). Typically when used with a closing device, the forceps 812 are designed to remain in place after the operation is completed to clamp the edges of the tissue together while the natural healing process brings them together. When the process has progressed enough that the tissue is able to hold itself together without the assistance of forceps 812, forceps 812 may be removed (eg, by a separate procedure) or may be left in place to fall away naturally as the clamped tissue falls away.

[0024] In the operative configuration, the elongated body 101 is inserted into a living body (e.g., after passing through a natural body orifice along a tortuous path) such that its distal end is positioned adjacent to a target location. In this position, the forceps 812 are moved distally out of the capsule 810 such that the arms 818 separate under the action of a natural bias into a tissue receiving configuration. At any time before or after advancing the forceps 812 out of the capsule 810, rotation may be applied to the proximal end of the elongated body 101 to rotate the capsule 810 and forceps 812 to orient the arms 818 relative to the target tissue as desired. The control guide wire 814 is then actuated to pull the forceps 812 proximally into the capsule 810, which closes the forceps arms 818 on the target tissue. When the forceps 812 are pulled into the capsule 810 to the maximum proximal extent, the capsule 810 constrains the arms 818 to remain in a closed position while the distal ends of the arms 818 are pulled together. At this point, additional proximal force is applied to the control wire 814, increasing the tension on the control wire until a predetermined tension is reached, causing the bond between the two portions 820a, 820b of the core member 822 connected between the control wire 814 and the forceps 812 to fail. This releases the capsule 810 and forceps 812 from the elongated body 101 and locks the forceps 812 in a closed position on the clamped tissue.

[0025] In this exemplary embodiment, the capsule 810 is removably connected to the elongated body 101 via a sleeve 822. When the severed proximal portion 820a of the core member 820 is pulled proximally out of the capsule 810, it pushes the sleeve support 824 out of the protrusion 826 connecting the sleeve 822 to the capsule 810, thereby removing the capsule 810 from the elongated body 101. That is, when the sleeve support 824 is moved out of its radially outward position supporting the protrusion 826, the protrusion 826 pops out radially inward out of the corresponding window on the proximal end of the capsule 810. This allows the capsule 810 to separate from the sleeve 822 connected to the elongated body 101, allowing the forceps 812 to remain on the target tissue while the device 800 is withdrawn from the body.

[0026] like Figure 2 As shown in , a device 200 according to an alternative embodiment of the present invention is substantially identical to the device 100, and like elements are referenced with like reference numerals except as noted below. The device 100' includes a plastic extrusion 220 formed on the braided second portion 110. The plastic extrusion 220 is positioned on the braided second portion 110 and is remelted (e.g., by heating) to lock the braided second portion 110 on the first portion 102 in a desired configuration. In another embodiment, the plastic extrusion 220 can be positioned between the first and second portions 102, 110 and then remelted (e.g., by heating) to move the device 200 to a locked configuration in which the first and second portions 102, 110 cannot move relative to each other. By disposing the plastic extrusion 220 on the outer surface of the braided second portion 110, a protective coating is provided to protect the working channel (not shown) of the endoscope (not shown) from damage, while also preventing / minimizing kinking when the device 200 is inserted into the working channel, as will be appreciated by those skilled in the art. The exemplary plastic extrusion 220 can be formed as a heat shrink tubing.

[0027] Figure 3 A device 300 according to another embodiment of the present invention is depicted, wherein the device 300 can be moved to a locked configuration without the use of plastic extrusion. The device 300 is substantially identical to the device 100, and like elements are referenced by like numbers except as noted below. Specifically, the braided pattern design of the braided second portion 310 can be formed to lock onto the first portion 102 using a braided locking pattern along a single portion, multiple portions, or the entire length of the device 100. That is, the intersections 116 of the wires 312 of the device 300 interlock with the peaks and valleys formed by the wound wire 104 forming the coil first portion 102. The braided crossovers can be formed such that some crossovers 330 occur in the valleys 340 of the coil first portion 102, while other crossovers 332 occur at the peaks 342 of the coil first portion 102. As Figure 3As shown in, a cross can be formed on one of the peaks, valleys, or at a combination of the two to lock the second portion 310 to the coil first portion 102. This construction can be used to simulate a tear-resistant fabric so that the second portion 310 can be prevented from unwinding or other damage. If a section of the second portion 310 is damaged, the exemplary structure will prevent the damage from extending to other parts of the second portion. In addition, the exemplary structure disclosed above helps to disperse the stress load on a single intersection 330 to further prevent the application of stretching that may cause it to break.

[0028] In the exemplary embodiment, the device 300 is formed by four wires or carriers 310, each wire or carrier 310 comprising four strands 112. However, it should be noted that the number of wires 310 and strands 112 per wire may vary without exceeding the scope of the present invention.

[0029] In still another embodiment, the second portion 110 , 210 , 310 may be locked in place by mechanical processing, including but not limited to crimping, welding, and riveting the second portion 110 , 210 , 310 to the first portion 102 .

[0030] Figure 4 Device 400 is depicted in accordance with another embodiment of the present invention. Device 400 is substantially the same as device 100 except as noted below. Device 400 includes a braided second portion 410 formed from a plurality of groups of wires 412, each group of wires including two wires 414. The warp density of second portion 410 over length L1 may be greater than the warp density of device 100 to increase the stiffness of device 400. The warp density may be selected to meet the requirements of a particular procedure and may vary along the length of device 400. As shown in FIG. Figure 5 In the illustrated device 500, the warp density over the length L1 may be reduced, resulting in a corresponding increase in the angle α.

[0031] The braiding pattern is selected to form the second portion 410 so that the size of the first female void 440 (e.g., a substantially diamond-shaped opening) formed between the first group of adjacent wires 412 is different from the size of the second female void 442 formed between the second group of adjacent wires 412. The pattern is imparted to the second portion 410 during the braiding process. The pattern allows the device 400 to expand and compress longitudinally during use, thereby assisting the insertion of the device 400 into the body. In this embodiment, the first female void 440 is initially larger than the second female void 442. It should be further noted that any number of female voids 440, 442 of different sizes can be braided to impart the desired flexibility to the device 400. In addition, the braiding can be patterned so that only female voids of different sizes are included over a predetermined length. For example, in a non-limiting example, only the distal tip of the device 400 can include female voids of different sizes. The exemplary features of the device 400 can be used in combination with any other features disclosed herein to impart the desired flexibility to a selected portion of the device. It should be noted that the weaving patterns disclosed above are merely exemplary and variations thereof are contemplated within the scope of the present invention.

[0032] like Figure 6 , a shaft 600 according to yet another embodiment of the present invention is substantially the same as shaft 100, except as noted below. Shaft 600 includes a plurality of individual wires or strips 612 that are braided together. Each individual wire 612 is formed with a flat, substantially rectangular cross-section. However, it should be noted that any other cross-section shape, including but not limited to circular and elliptical, may be used without exceeding the scope of the present invention.

[0033] Figure 7An apparatus 700 according to another embodiment of the present invention is depicted. The apparatus 700 is substantially the same as the apparatus previously discussed except as noted below. A second portion 710 of the apparatus 700 includes a first wire 712a having strands 714a of a first diameter, and first and second wires 712a, 712b are braided to form an unbalanced braid pattern. The second portion 710 also includes a second wire 712b having strands 714b of a second diameter, the second diameter being less than the first diameter. That is, each of the four strands 714a of the first wire 712a has the same first diameter, while each of the four strands 714b of the second wire 712b has the same second diameter. As a result of this structure, although the first and second wires 712a, 712b are braided, the tension on each wire can be varied to increase and decrease the tension on portions of the second portion 710. Specifically, as will be appreciated by one skilled in the art, the tension on the larger diameter first wire 712a is greater than the tension on the second wire 712b. In another embodiment, an unbalanced braid can be achieved by braiding the first wire 712a in a clockwise direction while braiding the second wire in a counterclockwise direction. This unbalanced braid can be formed by the first and second wires 712a, 712b having the same diameter or different diameters. It should be noted that although the device 700 is described with the first and second wires 712a, 712b, any number of wires can be used in the device 700 without exceeding the scope of the present invention.

[0034] Exemplary embodiments of the present invention allow external rotation to be applied to device 100-700, wherein the entire device 100-700 can be rotated to impart corresponding rotation to a mechanism (e.g., a clamping device) connected to its distal end. With or without a handle disposed on the proximal end of the device, a surgeon or other user can apply the rotation. In contrast, a control guide wire mechanism, as used in current devices, requires the use of a handle so that rotation is imparted to the mechanism connected thereto. The exemplary external rotation of device 100-700 according to the present invention provides a further beneficial effect, transmitting rotation without bending or winding. Specifically, the rotation mechanism based on the control guide wire is susceptible to the influence of agitation and uncontrolled motion caused by winding during the rotation process and its distal end. This exemplary device is formed to prevent such winding or bending, and can effectively and accurately transmit rotation.

[0035] An exemplary braided second portion according to the present invention may be formed on the spiral first portion during the manufacturing process and may be formed by a braiding or crocheting pattern.

[0036] It will be appreciated by those skilled in the art that individual technical features of the embodiments described above may be omitted and / or combined to form alternative embodiments. In addition, it will be appreciated by those skilled in the art that various modifications may be made to the structure and method of the present invention without departing from the spirit or scope of the present invention. For example, although the present invention relates to a clamping device, the exemplary systems and methods may also be used to perform a biopsy operation or any other medical operation in which the rotation of the element needs to be improved by combining the opening / closing function of the device, the function of extending / withdrawing the device into the tissue, etc., as will be appreciated by those skilled in the art. Therefore, without departing from the spirit and scope of the present invention, the exemplary shaft according to the present invention may be used with any other medical device requiring precise rotational control, or may be installed in such devices for use. Therefore, the present invention is intended to cover modifications and variations of the present invention that fall within the scope of the appended claims and equivalents thereof.

Claims

1. A clamping device, comprising: the sac, which extends from the proximal end to the distal end; a forceps comprising two arms at least partially received within the capsule; a cannula having a distal end releasably coupled to the proximal end of the balloon; an elongated shaft coupled to the proximal end of the cannula, the elongated shaft comprising: a coil extending from a proximal end of the elongated shaft to a distal end of the elongated shaft, the coil having a passage extending longitudinally therethrough; and a braided portion extending around a portion of the coil, the braided portion comprising a plurality of wires intertwined so that a first wire and a second wire intersect to enclose a predetermined angle therebetween, the angle being at least 25 degrees and less than 55 degrees when viewed from a direction orthogonal to the axis of the elongated shaft, wherein each of the first wires comprises one, two or three wires and each of the second wires comprises one, two or three wires; a handle coupled to the forceps via a control guidewire; and a core member coupled between the control guidewire and the arms of the forceps; wherein the elongated shaft is configured to rotate and impart rotation to the forceps and the capsule to orient the two arms to a desired position; wherein the control guidewire is configured to be actuated to draw the forceps proximally into the sac; and The core member is configured to separate when subjected to a preset tension to release the forceps from the control guide wire and the elongated shaft.

2. A clamping device as described in claim 1, wherein the arms are capable of moving between an insertion form and a tissue receiving form, wherein in the insertion form, the arms are pulled proximally into the sac to pull the arms together; in the tissue receiving form, the arms extend distally from the sac to allow the arms to be separated from each other.

3. The clamping device of claim 1, wherein each wire comprises the same number of wire filaments.

4. The clamping device of claim 1, wherein the braided portion comprises eight wires twisted together.

5. The clamping device of claim 1, wherein a diameter of the wire of the first wire is the same as a diameter of the wire of the second wire.

6. The clamping device of claim 1, wherein a diameter of the wire of the first wire is different from a diameter of the wire of the second wire.

7. The clamping device of claim 1 further comprising a plastic extrusion on the braided portion to lock the orientation of the braided portion relative to the coil.

8. The clamping device of claim 7, wherein the plastic extrusion extends either over an outer surface of the braided portion or over an inner surface of the braided portion adjacent the coil.

9. The clamping device of claim 1, wherein the wire is wound at a preset warp and weft density.

10. The clamping device of claim 9, wherein the wire is wound in a locking braid pattern so that the crossing of the wire occurs either at the valleys of the coils, or at the peaks of the coils, or where the valleys and peaks of the coils meet.

11. The clamping device of claim 1, wherein the wire has a cross-section that is either rectangular or circular.

12. The clamping device of claim 1, wherein the handle is a proximal actuation handle configured to rotate the elongated shaft, the elongated shaft transmitting the rotation along its length such that the rotation of the elongated shaft rotates the forceps.

13. The clamping device as described in claim 1 further includes a sleeve support member, which is configured to be detachably engaged with one or more protrusions connecting the sleeve to the balloon, wherein when the separated portion of the core component is pulled proximally out of the balloon when subjected to the preset tensile force, the sleeve support member is pushed to disengage from the one or more protrusions, thereby removing the balloon from the slender shaft.

14. The clamping device according to claim 1, wherein: When the core members are separated, the arms of the forceps are locked in a closed position.

15. The clamping device according to claim 1, wherein: The coil includes a portion of reduced diameter at its distal end.

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