Disposable FURLOW surgical insertion device

Abstract

According to a general aspect, an insertion device includes an elongate member defining a lumen extending from a first end of the elongate member to a second end of the elongate member; a coupler configured to be coupled to the first end portion of the elongate member, the coupler defining a lumen; and an obturator having a first end portion, the first end portion of the obturator configured to be disposed within the lumen defined by the elongate member and to move from a first position within the lumen defined by the elongate member to a second position within the lumen defined by the elongate member.

Description

[0001] Cross Reference to Related Applications

[0002] This application is a continuation of and claims priority to U.S. Non-Provisional Patent Application No. 18 / 643,576, filed April 23, 2024, entitled “DISPOSABLE FURLOW INSERTION DEVICE,” which claims priority to U.S. Provisional Patent Application No. 63 / 498,926, filed April 28, 2023, entitled “DISPOSABLE FURLOW INSERTION DEVICE,” the disclosures of which are incorporated by reference herein in their entireties.

[0003] This application also claims priority to U.S. Provisional Patent Application No. 63 / 498,926, filed April 28, 2023, the disclosure of which is incorporated by reference herein in its entirety. TECHNICAL FIELD

[0004] The present disclosure relates generally to devices for insertion of a body implant, and more particularly, to disposable insertion devices for body implants, such as penile prostheses. BACKGROUND

[0005] One treatment for chronic, organic male erectile dysfunction is the implantation of a penile prosthesis that mechanically causes the penis to become erect. Such prostheses can have different physical configurations (e.g., materials, mechanical structures, and functions, etc.) and configurations (e.g., physical dimensions, etc.). For example, such penile prostheses can be in the form of a cylinder (e.g., malleable, inflatable, etc.) that is selected based on the physical requirements of the intended recipient (patient). For example, an appropriate penile prosthesis can be implanted into a single corpora (pair of corpora) of the penis of a patient by a medical professional who is trained in and knowledgeable about the implantation and use of penile prostheses.

[0006] Insertion devices (e.g., Furlow insertion devices) can be used to facilitate the insertion of a penile prosthesis into a single corpora of a patient. Such Furlow insertion devices can be used for the measurement of the length of insertion into a single corpora, as well as for facilitating the insertion of a penile prosthesis by deploying a needle carrying a suture, where the needle and / or suture are used to introduce (draw, pull, insert, implant, etc.) the prosthesis into the single corpora. SUMMARY

[0007] According to a general aspect, an insertion device includes an elongated member defining a lumen extending from a first end portion of the elongated member to a second end portion of the elongated member, a coupler configured to be coupled to the first end portion of the elongated member, the coupler defining the lumen, and an obturator having a first end portion configured to be disposed within the lumen defined by the elongated member and to move from a first position within the lumen defined by the elongated member to a second position within the lumen defined by the elongated member.

[0008] In some embodiments, the obturator has an end portion defining a receiving portion. In some embodiments, the obturator has an end portion defining a receiving portion configured to receive a portion of a needle. In some embodiments, the obturator has an end portion and the end portion of the obturator defines a recessed portion. In some embodiments, the obturator has an end portion and the end portion of the obturator defines a recessed portion having a tapered shape. In some embodiments, the obturator has a first end portion defining a recessed portion and a second end portion opposite the first end portion comprising a handle portion.

[0009] In some embodiments, the obturator includes an engagement member configured to engage the coupler to help prevent removal of the obturator from the lumen defined by the coupler. In some embodiments, the coupler includes an engagement member configured to engage the elongated member to couple the coupler to the elongated member. In some embodiments, the lumen of the coupler is configured to receive a portion of the elongated member, the coupler includes an engagement member extending into the lumen defined by the coupler, the engagement member configured to engage the elongated member to couple the coupler to the elongated member.

[0010] In some embodiments, the coupler includes an engagement member configured to engage the obturator. In some embodiments, the lumen of the coupler is configured to receive a portion of the obturator, the coupler includes an engagement member extending into the lumen defined by the coupler, the engagement member configured to engage the obturator. In some embodiments, the coupler includes a first engagement member configured to engage the elongated member to help couple the coupler to the elongated member and a second engagement member configured to engage the obturator. In some embodiments, the coupler includes a first engagement member extending into the lumen defined by the coupler and a second engagement member extending into the lumen defined by the coupler, the first engagement member configured to engage the elongated member to help couple the coupler to the elongated member, the second engagement member configured to engage the obturator.

[0011] In some embodiments, the obturator includes a tapered portion. In some embodiments, the elongated member defines a slot.

[0012] According to another aspect, a kit includes: a body implant; a delivery needle configured to be coupled to the body implant; and a delivery device having: an elongated member defining a lumen extending from a first end of the elongated member to a second end of the elongated member; a connector configured to be coupled to a first end portion of the elongated member; and an occluder having a first end portion configured to be disposed within the lumen defined by the elongated member and to move from a first position within the lumen defined by the elongated member to a second position within the lumen defined by the elongated member.

[0013] In some embodiments, an elongated member defines a slot configured to receive at least a portion of the delivery needle.

[0014] In some embodiments, the occluder includes a distal end portion configured to engage a portion of the delivery needle. In some embodiments, the occluder has an end portion defining a recessed portion that is initially configured to receive at least a portion of the delivery needle. In some embodiments, the occluder has an end portion defining a tapered recessed portion that is configured to receive at least a portion of the delivery needle. Attached Figure Description

[0015] Figure 1 A system according to one embodiment is illustrated schematically.

[0016] Figure 2 This is a perspective view of an insertion device according to one embodiment.

[0017] Figure 3 and Figure 4 yes Figure 2 A cross-sectional view of the insertion device.

[0018] Figure 5 and Figure 6 yes Figure 2 A cross-sectional view of a portion of the insertion device.

[0019] Figure 7 yes Figure 2 A perspective view of the slender component of the insertion device.

[0020] Figure 8 yes Figure 7 A cross-sectional view of a slender member.

[0021] Figure 9 yes Figure 2 Side view of the connector of the insertion device.

[0022] Figure 10 is a cross-sectional view of the coupler of Figure 9

[0023] Figure 11 is a side view of the obturator of the insertion device of Figure 2

[0024] Figure 12 is a side view of a portion of the obturator of Figure 11

[0025] Figure 13 is a side view of the obturator according to another embodiment.

[0026] Figure 14 is a side view of a portion of the obturator of Figure 13

[0027] Figure 15 and Figure 16 is a cross-sectional view of the obturator of Figure 13

[0028] Figures 17-19 A method of using an insertion device according to an embodiment is shown. DETAILED DESCRIPTION

[0029] Detailed embodiments are disclosed herein. It should be understood, however, that the disclosed embodiments are merely examples and can be practiced in various forms. Thus, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure. Furthermore, terms and phrases used herein are not intended to be limiting, but rather to provide an understandable description of the concepts.

[0030] As used herein, the term "a" or "an" is defined as one or more than one. As used herein, the term "another" is defined as at least a second or more. As used herein, the terms "includes" and / or "including" are defined as including (i.e., open transition). As used herein, the term "coupled" or "movably coupled" is defined as connected, although not necessarily directly and mechanically.

[0031] ​​​​​Generally, embodiments relate to medical devices, such as insertion devices for penile prostheses or other body implants. The term patient can be used hereafter for a person who benefits from the medical devices or methods disclosed in the present disclosure. For example, a patient can be a person whose body is implanted with a medical device or a person who benefits from the disclosed methods for operating the medical devices of the present disclosure. For example, in some embodiments, a patient can be a human male, a human female, or any other mammal.

[0032] The terms proximal and distal as described with respect to various devices, apparatuses, and components as discussed in the subsequent text of the present disclosure are referenced using a point of reference. As used in the present specification, the point of reference is the perspective of a person using the disclosed insertion device to implant a body implant, such as a penile prosthesis. The person can be a surgeon, physician, nurse, practitioner, technician, or the like who can perform the implant procedure. The term proximal refers to an area or portion that is closer or closest to the person during the implant procedure. The term distal refers to an area or portion that is further or furthest from the person.

[0033] Embodiments discussed herein can provide improvements to penile prosthesis insertion devices (e.g., Furlow procedure insertion devices, Furlow procedure insertion tools, insertion tools, devices, tools, etc.). For example, such insertion devices can be configured to be used in a single procedure and then discarded or disposed of. Some such insertion devices can have components that are coupled together that, when removed from one another, ruin the insertion device.

[0034] Figure 1 A system according to one embodiment is schematically illustrated. The system includes a delivery or insertion device 100, an implant 195, and a needle 190 coupled to the implant 195. In some embodiments, the implant 195 can be a penile implant or another type of implant configured to be placed in the pelvic region of a patient. In other embodiments, the implant 195 is configured to be placed at a different location within a patient’s body. In some embodiments, the needle 190 is coupled to the implant 195 via a suture. In other embodiments, the needle 190 is directly coupled to the implant 195 or coupled to the implant 195 via another mechanism.

[0035] The insertion device 100 includes an elongate member 110, a coupler 140, and an obturator 170. The elongate member 110 is coupled to the coupler 140, and the obturator 170 is coupled to the coupler 140. In some embodiments, the elongate member 110 is fixedly coupled to the coupler 140. In some embodiments, the obturator 170 is movably (such as slidably) coupled to the coupler 140. The obturator 170 has a portion configured to be disposed within a lumen defined by the elongate member 110.

[0036] In use, the needle 190 or a portion of the needle 190 can be placed or disposed within a lumen defined by the elongated member. The delivery device 100, including the needle 190, can be placed to a desired location within a patient's body. The obturator 170 can then be advanced or moved distally within the lumen defined by the elongated member 110. The obturator 170 is configured to engage the needle 190 and push the needle 190 out of the lumen defined by the elongated member 110. The delivery device 100 can then be removed from the patient's body and the needle can then be pulled or otherwise moved within the patient's body until the implant 195 is disposed at the desired location.

[0037] Figures 2-6 An insertion device 200 is shown in accordance with one embodiment. Figure 2 is a perspective view of the insertion device 200. Figure 3 and Figure 4 is a cross-sectional view of the insertion device. Figure 5 and Figure 6 is a cross-sectional view of a portion of the insertion device.

[0038] The insertion device 200 includes an elongated member 210, a coupler 240, and an obturator 270. The elongated member 210 is coupled to the coupler 240 and the obturator 270 is coupled to the coupler 240. In the illustrated embodiment, the elongated member 210 is fixedly coupled to the coupler 240.

[0039] As best shown in Figures 3-6 , the coupler 240 defines a lumen 242. A proximal end portion 212 of the elongated member 210 is configured to be disposed within the lumen 242 defined by the coupler 240. The proximal end portion 212 of the elongated member 210 includes an engagement portion or member 217. The engagement portion or member 217 extends from an outer surface 211 of the elongated member 210. The coupler 240 also includes an engagement member 244. The engagement member 244 of the coupler 240 extends into the lumen 242 defined by the coupler 240. The engagement member 244 of the coupler 240 is configured to engage or interact with the elongated member 210 to couple the elongated member 210 to the coupler 240. As Figure 6 best shown in , the engagement member 244 of the coupler 240 is configured to engage or interact with the engagement member 217 of the elongated member 210. In some embodiments, the engagement member 244 of the coupler 240 is configured to bend or flex to provide a snap-type coupling with the elongated member 210. In other embodiments, the elongated member 210 is coupled to the coupler via a different mechanism or a different type of coupling.

[0040] Figures 3-5As best shown, in the illustrated embodiment, the obturator 270 is movably coupled to the coupler 240. At least a portion of the obturator 270 is disposed within the lumen 242 defined by the coupler 240 and is configured to slide, translate, or otherwise move relative to the coupler 240. In the illustrated embodiment, the coupler 240 includes an engagement member 246. As will be discussed in greater detail below, the engagement member 246 extends into the lumen 242 defined by the coupler 240 and is configured to engage or contact a portion of the obturator 270.

[0041] At least a portion of the obturator 270 extends into the lumen 216 defined by the elongated member 210. The obturator 270 is configured to slide or otherwise move within the lumen 216 defined by the elongated member 210.

[0042] In use, a needle coupled to a body implant can be placed or disposed within the lumen 216 defined by the elongated member 210. The delivery device 200, including the needle, can be placed to a desired location within a patient's body. The obturator 270 can then be advanced or moved distally within the lumen 216 defined by the elongated member 210. The obturator 270 is configured to engage the needle and push the needle out of the lumen 216 defined by the elongated member 210. The delivery device 200 can then be removed from the patient's body and the needle can then be pulled or otherwise moved within the patient's body until the implant is disposed or positioned at the desired location.

[0043] Figure 7 and Figure 8 The elongated member 210 is shown. The elongated member 210 includes or defines a slot 218. The slot 218 is disposed at the distal end portion 214 of the elongated member 210 and is in communication with the lumen 216 defined by the elongated member 210. The slot 218 is configured to receive a needle to facilitate placement of the needle into the lumen 216 defined by the elongated member 210. The elongated member 210 also includes a tapered or constricted portion 213 of the lumen 216 at the distal end portion 214 of the elongated member 210. In some embodiments, the tapering or narrowing of the lumen 216 (the inner diameter of the lumen decreases toward the end of the elongated member 210) facilitates more accurate ejection or placement of the needle according to a user's desires. For example, the narrowing or tapering of the lumen 216 of the elongated member 210 can limit or minimize the exit angle of the needle from the lumen 216.

[0044] In the illustrated embodiment, the elongated member 210 includes a handle portion 215. The handle portion 215 extends from the outer surface 211 of the elongated member 210. The handle portion 215 can be grasped by a user during insertion of the delivery device 200 into a patient's body and during advancement or movement of the obturator 270 relative to the elongated member 210.

[0045] The elongated member 210 includes measurement markings 219. The measurement markings 219 can be configured to indicate to a user how far the elongated member 210 (or the delivery device 200) has been inserted into a patient. In some embodiments, the measurement markings 219 are laser etched onto the material of the elongated member 210. In such embodiments, the surface of the elongated member 210 including the measurement markings 219 can be smooth. In other embodiments, the measurement markings 219 can be formed in different ways. For example, the measurement markings 219 can be painted, colored, or otherwise marked on the surface of the elongated member 210.

[0046] Figure 9 and Figure 10 The coupler 240 is shown. In the illustrated implantation, the coupler 240 defines a lumen 242. The lumen 242 is configured to receive at least a portion of the elongated member 210 and at least a portion of the occluder 270. The coupler includes an engagement member 244 that is configured to engage the elongated member 210 to couple the elongated member 210 to the coupler 240. The engagement member 244 extends into the lumen 242 defined by the coupler 240. In some embodiments, the engagement member 244 is configured to bend or flex.

[0047] The coupler includes an engagement member 246. The engagement member 246 extends into the lumen 242 defined by the coupler 240 and is configured to engage the occluder 270. In some embodiments, the engagement member 246 is configured to contact or engage the occluder 270 to help prevent the occluder 270 from being removed from the coupler 240. Accordingly, the occluder 270 can move or slide within the lumen 242 defined by the coupler 240, but can not be completely removed from the lumen 242 of the coupler 240 in some embodiments.

[0048] In the illustrated embodiment, the coupler 240 includes a ridge or protrusion 248 that extends from an outer surface of the coupler 240. The ridge or protrusion 248 can facilitate grasping or holding the coupler 240 or the delivery device 200 during use of the device.

[0049] Figure 11 and Figure 12An obturator 270 of the delivery device 200 is shown. The obturator 270 includes ramps or elevations 272A and 272B. The ramps or elevations extend from an outer surface 271 of the obturator 270 and are configured to engage the coupler 240. For example, in some embodiments, the ramps or elevations 272A and 272B are configured to engage the engagement members 246 of the coupler 240. For example, in the illustrated embodiment, the proximal ramp 272A can engage the engagement members 246 of the coupler 240 when the obturator is placed in its most distal position. The distal ramp 272B can be configured to engage the engagement members 246 of the coupler 240 when the obturator is placed in its most proximal position. Additionally, in some embodiments, the distal ramp 272B can engage the engagement members 246 of the coupler 240 to help prevent removal of the obturator 270 from the coupler 240. In the illustrated embodiment, the obturator 270 includes two proximal ramps or elevations 272A and two distal ramps or elevations 272B. In other embodiments, the obturator includes a different number of ramps or elevations.

[0050] In the illustrated embodiment, the obturator 270 includes an association ramp or elevation 274. The association ramp or elevation 274 is configured to facilitate association of the obturator 270 and the coupler 240 and is configured to help prevent removal of the obturator 270 from the coupler 240. For example, in some embodiments, the association ramp or elevation 274 is configured to contact or engage the coupler 240 to prevent removal or disassociation of the obturator 270 from the coupler 240.

[0051] The distal end 276 of the obturator 270 includes or defines a recess 277. The recess 277 is configured to receive a portion of a needle. In some embodiments, the recess 277 is configured to receive a portion of a needle such that the needle can then be advanced by the obturator 270 in a linear manner within the lumen of the elongated member 210 (rather than pushing or advancing the needle at an angle). Linear advancement of the needle can facilitate more accurate placement of the needle within the body of a patient. In the illustrated embodiment, the recess 277 has a conical shape. In other embodiments, the recess 277 has a different shape, such as a rectangular or spherical shape.

[0052] In the illustrated embodiment, the obturator 270 also includes a groove 275. The groove 275 is disposed near the distal end 276 of the obturator 270. The groove 275 allows a smaller surface area of the outer surface of the obturator 270 to contact the inner surface of the lumen of the elongated member 210. Accordingly, there is less friction between the surfaces to facilitate movement of the obturator 270 relative to the elongated member 210.

[0053] The proximal end portion 278 of the obturator 270 includes a handle portion 279. The handle portion 279 can be grasped by a user to move the obturator 270 relative to the coupler 240 and the elongated member 210.

[0054] Figures 13 to 16 An obturator 370 according to another embodiment is shown. As shown in Figure 16 The proximal end portion 378 of the obturator 370 includes an extension portion 382. The extension portion 382 extends from a surface of the obturator 370 and is configured to engage the coupler. The engagement of the extension portion 382 with the coupler provides tactile feedback to the user. Accordingly, the user can more precisely move or slide the obturator 370 relative to the coupler.

[0055] Figures 17 to 19 Steps of placing an implant within a patient’s body using a delivery device are shown. As shown in Figure 17 The needle 290 can be associated with or coupled to the implant 195. In some cases, the needle 290 can be associated with the implant 195 via a suture. As shown in Figure 18 The needle 290 can be placed within a lumen defined by the elongated member 210 of the delivery device 200. In some cases, the needle can be inserted into the lumen via a slot defined through the elongated member 210. As shown in Figure 19 The delivery device 200 can be inserted into the patient’s body, such as into the patient’s penis P. Once the delivery device 200 (including the needle 290) is placed at a desired location within the patient’s body, the obturator 270 can then be moved distally or within the lumen defined by the elongated member 210. The obturator 270 is configured to engage the needle 290 and push the needle 290 out of the lumen defined by the elongated member 210. The delivery device 200 can then be removed from the patient’s body, and the needle 290 can then be pulled or otherwise moved within the patient’s body until the implant 295 is disposed at the desired location.

[0056] While certain features of described implementations have been illustrated as described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the examples.

Claims

1. An insertion device, comprising: An elongated member defining a lumen extending from a first end of the elongated member to a second end of the elongated member; A connector configured to be coupled to a first end portion of the elongated member, the connector defining a lumen; and A closure device having a first end portion configured to be disposed within a lumen defined by the elongated member, and to move from a first position within the lumen defined by the elongated member to a second position within the lumen defined by the elongated member.

2. The insertion device according to claim 1, wherein, The blocker has an end, and the end defines a receiving portion.

3. The insertion device according to claim 1, wherein, The blocker has an end, and the end of the blocker defines a receiving portion, which is configured as part of a receiving needle.

4. The insertion device according to claim 1, wherein, The occluder has an end, and the end of the occluder defines a recessed portion.

5. The insertion device according to claim 1, wherein, The occluder has an end, and the end of the occluder defines a conical recessed portion.

6. The insertion device according to claim 1, wherein, The occluder has a first end and a second end opposite to the first end, the first end defining a recessed portion, and the second end including a handle portion.

7. The insertion device according to any one of claims 1-6, wherein, The occluder includes an engaging member configured to engage the connector to help prevent the occluder from being removed from the lumen defined by the connector.

8. The insertion device according to any one of claims 1-6, wherein, The connector includes a coupling member configured to engage the elongated member to attach the connector to the elongated member.

9. The insertion device according to any one of claims 1-6, wherein, The lumen of the connector is configured to receive a portion of the elongated member, the connector including an engaging member extending into the lumen defined by the connector, and the engaging member being configured to engage the elongated member to attach the connector to the elongated member.

10. The insertion device according to any one of claims 1-6, wherein, The connector includes an engagement member configured to engage the occluder.

11. The insertion device according to any one of claims 1-6, wherein, The lumen of the connector is configured to receive a portion of the occluder, the connector including an engagement member extending into the lumen defined by the connector, and the engagement member being configured to engage the occluder.

12. The insertion device according to any one of claims 1-6, wherein, The connector includes a first engaging member and a second engaging member, the first engaging member being configured to engage the elongated member to facilitate connecting the connector to the elongated member, and the second engaging member being configured to engage the occluder.

13. The insertion device according to any one of claims 1-6, wherein, The connector includes a first engagement member extending into a lumen defined by the connector and a second engagement member extending into a lumen defined by the connector, the first engagement member being configured to engage the elongated member to facilitate coupling the connector to the elongated member, and the second engagement member being configured to engage the occluder.

14. The insertion device according to claims 1-13, wherein, The occluder includes a tapered portion.

15. The insertion device according to any one of claims 1-14, wherein, The elongated member defines a slot.

16. An insertion device, comprising: An elongated member that defines a lumen extending from a first end of the elongated member to a second end of the elongated member; A connector configured to be coupled to a first end portion of the elongated member, the connector defining a lumen; and A closure device having a first end portion configured to be disposed within a lumen defined by the elongated member, and to move from a first position within the lumen defined by the elongated member to a second position within the lumen defined by the elongated member.

17. The insertion device according to claim 16, wherein, The blocker has an end, and the end defines a receiving portion.

18. The insertion device according to claim 16, wherein, The blocker has an end, and the end of the blocker defines a receiving portion, which is configured as part of a receiving needle.

19. The insertion device according to claim 16, wherein, The occluder has an end, and the end of the occluder defines a recessed portion.

20. The insertion device according to claim 16, wherein, The occluder has an end, and the end of the occluder defines a conical recessed portion.

21. The insertion device according to claim 16, wherein, The occluder has a first end and a second end opposite to the first end, the first end defining a recessed portion, and the second end including a handle portion.

22. The insertion device according to claim 16, wherein, The occluder includes an engaging member configured to engage the connector to help prevent the occluder from being removed from the lumen defined by the connector.

23. The insertion device according to claim 16, wherein, The connector includes a coupling member configured to engage the elongated member to attach the connector to the elongated member.

24. The insertion device according to claim 16, wherein, The lumen of the connector is configured to receive a portion of the elongated member, the connector including an engaging member extending into the lumen defined by the connector, and the engaging member being configured to engage the elongated member to attach the connector to the elongated member.

25. The insertion device according to claim 16, wherein, The connector includes an engagement member configured to engage the occluder.

26. The insertion device according to claim 16, wherein, The lumen of the connector is configured to receive a portion of the occluder, the connector including an engagement member extending into the lumen defined by the connector, and the engagement member being configured to engage the occluder.

27. The insertion device according to claim 16, wherein, The connector includes a first engaging member and a second engaging member, the first engaging member being configured to engage the elongated member to facilitate connecting the connector to the elongated member, and the second engaging member being configured to engage the occluder.

28. The insertion device according to claim 16, wherein, The connector includes a first engagement member extending into a lumen defined by the connector and a second engagement member extending into the lumen defined by the connector, the first engagement member being configured to engage the elongated member to facilitate coupling the connector to the elongated member, and the second engagement member being configured to engage the occluder.

29. The insertion device according to claim 16, wherein, The occluder includes a tapered portion.

30. The insertion device according to claim 16, wherein, The elongated member defines a slot.

31. A kit comprising: Body implants; Delivery needles, which are configured to attach to body implants; and A delivery device having: an elongated member defining a lumen extending from a first end of the elongated member to a second end of the elongated member; A connector configured to be coupled to a first end portion of the elongated member; And a closure device having a first end portion, the first end portion of which is configured to be disposed within a lumen defined by the elongated member, and to move from a first position within the lumen defined by the elongated member to a second position within the lumen defined by the elongated member.

32. The kit according to claim 31, wherein, The elongated member defines a slot configured to receive at least a portion of the delivery needle.

33. The kit according to claim 31, wherein, The occluder includes a distal end portion configured to engage a portion of the delivery needle.

34. The kit according to claim 31, wherein, The occluder has an end portion that defines a recessed portion configured to receive at least a portion of the delivery needle.

35. The kit according to claim 31, wherein, The occluder has an end portion that defines a tapered recess that is configured to receive at least a portion of the delivery needle.

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