Method for coupling device components and related device having such components

Abstract

To provide a method for coupling an improved device element to another device element, and an instrument or a medical device including the elements coupled by the method.SOLUTION: A method for coupling a first medical device element to a second medical device element comprises: altering the first medical device element from a natural state to an altered state, by diameter reduction of a cross-sectional dimension of the first medical device element; and fitting a first portion of the first medical device element in the altered state into a first opening of the second medical device element. The first medical device element includes a second portion not disposed within the first opening of the second medical device element, and allows the second portions of the first medical device element to revert back to the natural state.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] The present invention relates to connecting device elements to other device elements. Examples of the present invention relate to a method of connecting a nitinol wire to another element, such as another element of a medical device formed of a different material, such as a therapeutic or diagnostic instrument. Another example of the present invention relates to an instrument or medical device comprising elements connected by the method described herein.

Background Art

[0002] Nitinol has superelastic properties that impart high flexibility, shape memory, kink resistance, high fatigue strength, corrosion resistance, and heat resistance. Therefore, nitinol is an ideal material for medical devices and instruments, particularly those having a wire shape. A medical device including a nitinol component can be assembled by adhering, welding, crimping, and / or caulking the nitinol component to another component of the medical device. However, these methods can be difficult due to the hard oxide outer layer of nitinol, and the bonding / connection during and after joining is limited. A filler material may be required to weld or solder nitinol to stainless steel, which generally creates a weak point within the bond. Also, it may reduce the thermal properties of nitinol that give it shape memory characteristics.

Summary of the Invention

[0003] According to one example, a method for connecting a first medical device element to a second medical device element includes changing the first medical device element from a natural state to a modified state by reducing the cross-sectional dimension of the first medical device, fitting a first portion of the first medical device element in a modified state into a first opening of the second medical device element, the first portion of the first medical device element in the modified state including a second portion that is not disposed within the first opening of the second medical device element, and making the second portion of the first medical device element recoverable to the natural state.

[0004] In another example, the method may further include, after the fitting step, a step of increasing the cross-sectional dimension of the first portion of the first medical device element to the dimension of the opening. In another example, the changing step includes applying a force to the medical device element in a direction transverse to the direction of the cross-sectional dimension, and the enabling step includes removing the force. In the natural state, the first medical device element may be dimensionally restricted from entering the first opening. The first medical device element may be a wire. The wire may contain nitinol. The changing step may include a step of stretching the wire so that the diameter of the wire is less than or equal to the width of the first opening. The second medical device element may be disk-shaped, and the first opening may include a slot extending from the outer edge of the second medical device element to a point radially inward.

[0005] In another example, the first medical device element may be a wire, and the fitting step may include a step of sliding the second medical device element on the wire through the slot. The second medical device element may include a second opening, and the method may further include fitting a third portion of the first medical device element in the changed state into the second opening.

[0006] In another example, the method may further include a step of fitting a third portion of the first medical device element into the first opening of the second medical device element. In another example, the first medical device element may be connected to the second medical device element so that the first medical device element does not rotate relative to the second medical device element. The first medical device element may be a drive element for driving an end effector of the medical device. A single wire may include the drive element and the end effector, and the end effector may include a snare loop. The single wire may contain nitinol, and two portions of the single wire may be fitted into the second medical device element.

[0007] According to another example, the medical device may include a nitinol wire defining a loop, a first strand, and a second strand, the first strand and the second strand each extending proximally to the loop and may include a receiving element coupled to the first strand and the second strand, the receiving element having a first opening, a portion of the first strand extending into the first opening, the diameter of a portion of the first strand being smaller than the diameter of the remaining portion of the first strand. A portion of the second strand extends into the first opening, and the diameter of a portion of the second strand is smaller than the diameter of the remaining portion of the second strand. The receiving element may further include a second opening, a portion of the second strand extending into the second opening, and the diameter of a portion of the second strand is smaller than the diameter of the remaining portion of the second strand. The diameter of a portion of the first strand may be smaller than the diameter of the portion of the nitinol wire defining the loop.

[0008] According to another example, the medical device may include a shaft, a handle connected to the proximal portion of the shaft, a nitinol wire extending from the handle to the shaft, and a receiving element, the receiving element being disposed within the handle or the shaft, a portion of the nitinol wire extending through the receiving element, and the diameter of a portion of the nitinol wire being smaller than the diameter of the remaining portion of the nitinol wire.

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description serve to explain the principles of the disclosed embodiments.

Brief Description of the Drawings

[0010]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 4

DETAILED DESCRIPTION OF THE INVENTION

[0011] Here, aspects of the present invention will be referred to in detail, and examples thereof are shown in the accompanying drawings. As far as possible, the same or similar reference numerals are used throughout all the drawings to refer to the same or similar components. The term "distal" refers to the part that is farthest from the user when the device is introduced into the body of a subject (e.g., a patient). In contrast, the term "proximal" refers to the part that is closest to the user when the device is placed in the body of the subject.

[0012] Both the above general description and the following detailed description are merely illustrative and explanatory and do not limit the claimed features. As used herein, the terms "comprising", "containing", "having", "including", or other variations thereof mean that a process, method, article, or device comprising a list of elements does not include only those elements but may include other elements not explicitly listed or other elements specific to such a process, method, article, or device. In the present invention, for example, relative terms such as "about", "substantially", "generally", and "approximately" are used to indicate possible variations of ±10% in the described value or characteristic.

[0013] Aspects of the present invention can solve one or more of the limitations in the art. However, the scope of the present invention is defined by the appended claims and not by the ability to solve a particular problem. The present invention relates to a method for connecting device elements to other elements and a medical device / instrument including the elements connected by this method. In an exemplary embodiment, the device element is a wire, for example, a wire containing nitinol, a nickel-titanium alloy having superelastic properties. However, the present invention is not limited to wires containing nitinol. The device element, for example, a wire suitable for use in the methods and devices according to the present invention, may include any material that can be stretched / elongated when a force is applied and return to its original non-stretched form when the force is removed. Throughout this specification, embodiments refer to wires made of nitinol. However, any material mentioned in this specification and other suitable materials may be used in the methods and devices according to the embodiments of the present invention.

[0014] In the exemplary embodiments described herein, the element that is modified to connect to another device element is a wire. Another element that can be stretched in one direction and shortened in another direction can be used in the devices and methods according to the embodiments of the present invention.

[0015] According to an exemplary embodiment, a nitinol element can be modified to connect to other materials and elements via a receiver. Thus, in the method described in more detail below, the nitinol component can be connected to other materials without using a filler or adhesive or performing heat exposure. Such a receiver can be implemented in various medical devices or instruments containing nitinol, such as endoscopes, instruments having end effectors, and the like.

[0016] Referring to FIGS. 1A-2D, an example of a method for connecting / fixing a Nitinol wire 100 to a receiver 200 will be described. The Nitinol wire 100 has a diameter D. The diameter D is not particularly limited and can be in the range of about 0.02 inches (about 0.51 millimeters) to 0.04 inches (about 1.02 millimeters), for example, about 0.029 inches (about 0.74 millimeters). The Nitinol wire 100 has a circular cross-section, but is not particularly limited thereto. The diameter D is larger than the width W of the opening 210 of the receiver 200. The receiver 200 is disk-shaped and is made of any suitable material such as stainless steel. The receiver 200 is formed of a material different from that of the wire 100. The opening 210 communicates with a slot 215 having a width W over its entire length. The width W should be smaller than the diameter D of the wire 100, but is not particularly limited and can be, for example, about 0.028 inches (about 0.71 millimeters). The slot 215 extends from the outer surface to an end point 220, and the end point 220 can be located at or around the center point of the disk-shaped receiver 200. The end point 220 can be shaped to correspond to the cross-sectional shape of the Nitinol wire 100. However, the Nitinol wire 100 does not fit into the receiver 200 as shown by the dotted outline representing the outer periphery of the wire 100 in FIG. 1B in its unaltered state without force being applied.

[0017] To couple the Nitinol wire 100 to the receptacle 200, the Nitinol wire 100 can be modified by any suitable method to conform to the opening 210 and slot 215 of the receptacle 200. For example, the Nitinol wire 100 can be stretched to form a reduced-diameter Nitinol wire 100' having a diameter D' as shown in FIG. 2A. The extent to which the Nitinol wire 100 is reduced in diameter to the Nitinol wire 100' is not particularly limited as long as the Nitinol wire 100' has a diameter D' that is less than or equal to the width W of the opening 210 of the receptacle 200. For example, the diameter D' ranges from about 0.02 inches (about 0.51 millimeters) to 0.04 inches (about 1.02 millimeters), such as about 0.028 inches (about 0.71 millimeters), and is equal to or less than 0.028 inches (about 0.71 millimeters) of the width W. Further, the Nitinol wire 100 can be modified / stretched in any suitable manner. For example, one or both ends of the Nitinol wire 100 can be secured to a hydraulic press or any other suitable pulling fixture. Next, the Nitinol wire 100 can be drawn out by elastically stretching the Nitinol wire 100 using a hydraulic press or a pulling fixture. The Nitinol wire 100 can be stretched to the above extent prior to the Nitinol wire 100 reaching the breaking point.

[0018] Since the elongated Nitinol wire 100' has a diameter D', the elongated Nitinol 100' can then be fitted / inserted into the receiver 200 through the opening 210 (shown in FIGS. 2A-2B). Due to the shape recovery characteristics of Nitinol, the Nitinol wire 100' is fitted / slid into the opening 210 and the slot 215 before recovering to its original dimensions, e.g., diameter D. Thus, the Nitinol wire 100' can be connected to the receiver 200 while maintaining the diameter D'. The method by which the Nitinol wire 100' is attached to the receiver 200 is not particularly limited. For example, the receiver 200 may be slid over the Nitinol wire 100' through the opening 210 until the Nitinol wire 100' reaches the end 220 of the slot 215. Further, the receiver 200 is not limited to receiving one Nitinol element, e.g., a single Nitinol wire, and may be configured to receive a plurality of Nitinol wires. For example, a plurality of Nitinol wires can be stacked within the slot 215 and / or the receiver 200 may include a plurality of openings and slots radially disposed around the receiver 200. The opening 210 of the receiver 200 is not particularly limited to a slot. The opening 210 may be any suitable opening capable of receiving the wire 100'. For example, the opening 210 of the receiver 200 may be a through-hole through which the wire 100' can be passed in its elongated state instead of a slot.

[0019] When the Nitinol wire 100' is attached to the receiver 200, the force applied to the Nitinol wire 100' is removed, and the Nitinol wire 100' can move to a relaxed state. As a result, the portion of the Nitinol wire 100' that is not fitted into the slot 215 can return to its original dimensions, for example, diameter D. The portion of the Nitinol wire 100' fitted into the slot 215 expands to a diameter corresponding to the width W. For example, when the diameter D' is smaller than the width W, the portion of the Nitinol wire 100' fitted into the slot 215 of the receiver 200 can expand to fill the width W. As a result, the Nitinol wire 100' is securely fitted into the slot 215 of the receiver 200. In an exemplary embodiment, the receiver 200 can be connected to the Nitinol 100' so as not to be rotatable relative to the Nitinol wire 100'. The remaining portion of the Nitinol wire 100' returns to its original diameter D, for example, about 0.029 inches (about 0.74 millimeters), due to its shape recovery characteristics. As a result, the receiver 200 is restrained from moving along the longitudinal axis of the Nitinol wire 100' due to the interference fit between the wire 100' and the receiver 200.

[0020] As described above, the device element that is modified and connected to another device element is not limited to being a wire. The device element can be of any suitable shape or form having a first form that prevents the element from being fitted into the receiver 200 through the opening 210 and a second form that is modified to be fitted into the opening 210.

[0021] Similarly, the receiver 200 is not limited to a disk shape, and the opening 210 and the slot 215 are not limited to those shown in the drawings. The receiver 200 can be of any suitable material and form / shape. The opening 210 and the slot 215 can be of any suitable width and shape as long as they are configured to receive the device element in its second modified form. In some examples, the receiver 200 can include a plurality of openings and slots having different shapes and / or dimensions. Further, as described above, the modification of the device element from the first form to the second form is not limited to elongation. The device element can be modified in any suitable manner to conform to the opening 210.

[0022] The above method can be used to connect a device element, such as a nitinol component, to another medical device element, such as a medical device or a receiver of a medical device. With reference to FIGS. 3A-4, examples of such medical devices and devices are described below.

[0023] FIG. 3A shows a medical device 50 including a single nitinol wire 100'' used for a drive element 51 and an end effector 54. The wire 100'' extends distally from another medical device element, such as a handle (not shown). The drive element 51 forms the proximal side of the end effector 54. The drive element 51 can be connected to a handle (not shown) at the proximal end of the device in any suitable manner. The drive element 51 and the end effector 54 can move linearly along the longitudinal axis of the element 51. Both the element 51 and the end effector 54 can extend through a sheath (not shown) of the device. The loop of the end effector 54 can open and close as the end effector 54 enters and exits the sheath (not shown).

[0024] The Nitinol wire 100’’ is in the shape of a wire, cable, or ribbon and is formed in any suitable cross-sectional shape or dimension that adapts to the receiver 61. The portion of the wire 100’’ proximal to the end effector 54 is the first strand 52 of the drive element 51. The portion of the Nitinol wire 100’’ distal to the drive element 51 defines the end effector 54, for example, a distal loop in a plane. The dimensions and shape of the end effector 54 are not particularly limited and can be, for example, circular, elliptical, teardrop-shaped, etc. The most distal end of the end effector 54 can include the tip 55. The tip 55 can be a distal protrusion, thereby forming a traumatic distal end. However, the tip 55 is not particularly limited in the end effector 54 and is not necessary. In some other embodiments, the end effector 54 can have a non-traumatic distal end.

[0025] The distal portion of the Nitinol wire 100’’ forms a loop of the end effector 54 by looping back on itself and changing direction. The remaining portion of the wire 100’’ distal to the portion of the wire 100’’ forming the end effector 54 extends linearly to form the second strand 53. The first strand 52 and the second strand 53 are parallel to each other and both are proximal to the loop 54. The length of the second strand 53 is not particularly limited. The strands 52, 53 can be arranged in contact with each other or spaced apart by any suitable distance corresponding to the opening of the receiver 60.

[0026] Continuing to refer to FIGS. 3A-3B, the medical device 50 further includes a receiver 60. The receiver 60 can be formed of any suitable material, such as stainless steel for example. The receiver 60 is an annular / ring-shaped element that includes an opening 61. However, the receiver 60 is not particularly limited to being a ring and can be of any suitable shape and / or dimensions as described above. The receiver 60 is a complete closed ring. However, in another exemplary embodiment, the receiver 60 can be a partial ring that includes a break in its annular structure. The break can be any suitable distance that allows the receiver 60 to receive and hold the strands 52, 53. The opening 61 can be of any suitable shape, such as circular, rectangular, etc., and can be a shape that conforms to the cross-sectional shape of the strands 52, 53. The opening 61 should have a width or diameter that is smaller than the combined total diameter of the strands 52, 53, but is not particularly limited. In another exemplary embodiment, the receiver 60 can have two separate openings for the corresponding strands 52, 53. In such an embodiment, both openings can have a diameter that is smaller than the respective diameter of the strands 52, 53.

[0027] The strands 52, 53 of the Nitinol wire 100'' are connected to the receiver 60 by the above-described connection method. The strands 52, 53 have an unchanged state, for example, in a first form, a total width / diameter that is larger than the width / diameter of the opening 61. The strands 52, 53 are changed to a second form, for example, elongated / reduced in diameter, and are connected to the receiver 60. As shown in FIG. 3B, the strands 52, 53 are reduced in diameter so that they fit within the opening 61. In some examples, the strands 52, 53 are elongated and inserted into the opening 61 sequentially or simultaneously. In another example, since the Nitinol wire 100'' is elongated before forming the distal loop 54, the strands 52, 53 are already in a reduced diameter / elongated state when connected to the receiver 61. Regardless of the method implemented, the change to the second form involves a reduction in the cross-sectional dimensions of the device elements, such as the strands 52, 53.

[0028] After the strands 52, 53 are reduced in diameter, the receiver 60 is attached over the reduced-diameter strands 52, 53 (or Nitinol wire 100'' reduced in diameter prior to forming the loop 54) via the opening 61. The method by which the receiver 60 is attached over the strands 52, 53 is not particularly limited. In some examples, the receiver 60 is attached over the reduced-diameter strands 52, 53 before the drive element 51 is coupled to another device element, such as a handle (not shown). In another example, the receiver 60 is attached over the reduced-diameter Nitinol wire 100'' before forming the loop of the end effector 54. Subsequently, during or after formation of the end effector 54, the portion of the Nitinol wire 100'' (forming the second strand 53) that turns loop-like can be slid into the opening 61. In another exemplary embodiment where the receiver 60 is a partial ring, the receiver 60 can be slipped over the reduced-diameter strands 52, 53 through the break of the partial ring. The receiver 60 can be mounted over the strands 52, 53 in a variety of other ways beyond the above examples.

[0029] After the receiver 60 is attached to the strands 52, 53, the force applied to the strands 52, 53 can be removed so that the strands 52, 53 can transition to a relaxed state. Thereby, the portion of the strands 52, 53 attached within the opening 61 can expand to the extent permitted by the opening 61. However, the mating portions of the strands 52, 53 do not expand back to their original diameter due to the spatial constraints of the opening 61. On the other hand, the remaining portions of the strands 52, 53 that are not fitted within the opening 61 return to their original dimensions, such as diameter, due to the shape memory characteristics of the Nitinol wire 100''. Thus, the receiver 60 can be inhibited from moving along the longitudinal axis of the strands 52, 53 by an interference fit between the strands 52, 53 and the receiver 200.

[0030] Figures 3C to 3D show an apparatus similar to that shown in Figures 3A to 3B, except that the receiver 60' is different from the receiver 60. The receiver 60' includes two openings 61', 62. The openings 61', 62 are configured to receive the first and second strands 52, 53, respectively. Thus, the opening 61' can be disposed directly below the opening 62. The openings 61', 62 are spaced apart according to the distance from the strands 52, 53. The opening 61' is a clamp-shaped opening for receiving the first strand 52. The opening 61' can be of any suitable shape adapted to the first strand 52. The opening 61' can be of any suitable width that is less than or equal to the width / diameter of the first strand 52 when unchanged. The opening 62 receives the second strand 53. The opening 62 is within the structure of the receiver 60 and extends longitudinally. Thus, unlike the opening 61', the opening 62 is a completely enclosed opening. The opening 62 can be of any suitable shape adapted to the second strand 53. The opening 62 can be of any suitable width / diameter that is smaller than the width / diameter of the second strand 53 when in the unchanged state.

[0031] The strands 52, 53 of the nitinol wire 100'' are also connected to the receiver 60' via the above-described connection method. For example, since the second strand 53 is modified, e.g., stretched / reduced in diameter, the receiver 60' can be slid onto the second strand 53 through the opening 62. The receiver 60' is attached to any portion of the second strand 53 as long as it is proximal to the distal loop 54. In some examples where the width of the opening 61' is smaller than the width / diameter of the first strand 52, the first strand 52 is also modified, e.g., stretched / reduced in diameter, so that the first strand 52 can be fitted into the clamp-shaped opening 61'. In other examples where the width of the opening 61' is equal to or approximately equal to the width / diameter of the first strand 52, the unmodified first strand 52 is fitted into the clamp-shaped opening 61' by any suitable method.

[0032] Figure 4 shows an example of a medical device, such as an endoscope, that includes Nitinol components connected to other medical device elements, such as receivers. Endoscope 10 includes a flexible shaft 20, a tip 30 at the distal end of endoscope 10, and an articulating joint 50 disposed between and connecting flexible shaft 20 and tip 30. A handle 40 or other device for driving or controlling endoscope 10, and any tools or devices associated with endoscope 10, are connected to the proximal end of flexible shaft 20.

[0033] A plurality of drive elements, such as Nitinol operating wires 48, 49 suitable for medical procedures, may extend distally from handle 40. Wires 48, 49 may be supported and fixed by medical device elements, such as a plurality of receivers 45, 47, 25, and 27, etc., by the above connection method. Thus, wires 48, 49 can be securely fitted into receivers 45, 47, 25, and 27 by an interference fit between the wire and the receiver. Proximal receivers 45, 47 are disposed at appropriate positions within handle 40. The method of disposing receivers 45, 47, such as molding, adhesion, etc., is not particularly limited. Receivers 45, 47 can be any of the above receivers or a modification thereof. Distal receivers 25, 27 are disposed within shaft 20. Additionally or alternatively, distal receivers 25, 27 can be disposed at any appropriate location within tip 30 or articulating joint 50. The method of disposing receivers 25, 27, such as molding, adhesion, etc., is not particularly limited. Receivers 25, 27 can be any of the above receivers or a modification thereof.

[0034] Nitinol wires 48, 49 can be indirectly connected to a first drive device 42 and a second drive device 43 that control the articulating movement of articulating joint 50 in multiple directions. Devices 42, 43 can be, for example, rotatable knobs that rotate about their axes to push or pull Nitinol operating wires 48, 49.

[0035] Alternatively or additionally, the user may operate the control wires 48, 49 independently of the handle 40. The distal ends of the control wires 48, 49 extend through the flexible shaft 20 and terminate at the articulation joint 50 and / or the tip 30. For example, one or more of the control wires 48, 49 can be coupled to the articulation joint 50 and one or more other control wires 48, 49 can be attached to the tip 30. Driving the control wires 48, 49 can control elements attached to the tip 30, such as the articulation joint 50, the tip 30, and / or an end effector (not shown). Further, one or more electrical cables (not shown) extend from the proximal end of the endoscope 10 to the tip 30 to provide electrical control to imaging devices, lighting devices, and / or other electrical devices on the tip 30 and to deliver imaging signals from the tip 30 in the proximal direction for processing and / or display on a display. The handle 40 may include ports 44, 46 for introducing and / or removing instruments, fluids, or other substances from the patient. Port 44 may be used for introducing instruments. Port 46 may be connected to an umbilicus for introducing fluid aspiration and / or wiring of electronic components.

[0036] Those skilled in the art will appreciate that various modifications and variations can be made to the disclosed staple fastening mechanism without departing from the scope of the invention. For example, the configuration of the coupler, actuator, and stapler can be changed to fit any medical device and is not limited to the examples described herein. Other embodiments of the invention will be apparent to those skilled in the art in view of the specification and practice of the invention disclosed herein. The specification and examples are to be considered exemplary only, and the scope and spirit of the invention are intended to be indicated by the following claims.

Claims

1. Changing the first medical device element from a natural state to an altered state by reducing the cross-sectional dimension of the first medical device element; Inserting a first portion of the first medical device element in the altered state into a first opening of a second medical device element, the first medical device element including a second portion that is not disposed within the first opening of the second medical device element; Returning the second portion of the first medical device element to the natural state; A method for connecting a first medical device element to a second medical device element, comprising:

2. The method of claim 1, further comprising, after the inserting step, increasing the cross-sectional dimension of the first portion of the first medical device element to the dimension of the first opening.

3. The method of claim 1 or 2, wherein the changing step includes applying a force to the medical device element in a direction orthogonal to the direction of the cross-sectional dimension, and the returning step includes removing the force.

4. The method according to any one of claims 1 to 3, wherein in the natural state, the first medical device element is dimensionally restricted from entering the first opening.

5. The method according to any one of claims 1 to 4, wherein the first medical device element is a wire.

6. The method of claim 5, wherein the wire comprises nitinol.

7. The method of claim 6, wherein the changing step includes stretching the wire such that the diameter of the wire is less than or equal to the width of the first opening.

8. The method according to any one of claims 1 to 7, wherein the second medical device element is disc-shaped and the first opening includes a slot extending radially inwardly from an outer edge of the second medical device element to a point.

9. The method of claim 8, wherein the first medical device element is a wire and the inserting step includes sliding the second medical device element over the wire through the slot.

10. The method according to any one of claims 1 to 9, wherein the second medical device element includes a second opening and the method further includes inserting a third portion of the first medical device element in the altered state into the second opening.

11. The method according to any one of claims 1 to 10, further comprising inserting a third portion of the first medical device element into the first opening of the second medical device element.

12. A Nitinol wire defining a loop, a first strand, and a second strand, wherein the first strand and the second strand each extend proximally to the loop, and the Nitinol wire, a receiving element coupled to the first strand and the second strand comprising: the receiving element includes a first opening, and a portion of the first strand extends through the first opening, a diameter of the portion of the first strand is smaller than a diameter of a remaining portion of the first strand, a medical device.

13. A portion of the second strand extends through the first opening, and a diameter of the portion of the second strand is smaller than a diameter of a remaining portion of the second strand, the medical device according to claim 12.

14. The receiving element further includes a second opening, a portion of the second strand extends into the second opening, and a diameter of the portion of the second strand is smaller than a diameter of a remaining portion of the second strand, the medical device according to claim 13.

15. A diameter of the portion of the first strand is smaller than a diameter of a portion of the Nitinol wire defining the loop, the medical device according to any one of claims 12 to 14.

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