Occlusive implants for hollow anatomical structures, delivery systems, and related methods

• US 9,119,948 B2
• Filed: 02/20/2013
• Issued: 09/01/2015
• Est. Priority Date: 02/20/2013
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Lee, Stephen, Stevens, Walter
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/771,133
• Publication Number:
  US 20140236127A1
• Time in Patent Office: 923 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence

Abstract

An implant and delivery system including a female coupler at a proximal end of the implant and a male coupler at a distal end of an elongate tubular delivery member. The male coupler is insertable within the female coupler and expandable under the influence of an elongate control member that is slidable within the tubular delivery member. Expansion of the male coupler locks the implant to the tubular delivery member. Withdrawal of the control member unlocks the implant from the tubular delivery member, enabling placement of the implant within a body.

Claims

1. Apparatus for delivering an occlusive implant in a hollow anatomical structure, the apparatus comprising:

an elongate flexible delivery tube having a proximal end and a distal end, and defining an internal delivery tube lumen having an inner lumen diameter;

a male coupler at the distal end of the delivery tube and defining an internal male coupler lumen, the male coupler including a plurality of cantilevered flexible legs each including a distal end, each of the legs including an internal surface that defines at least a portion of the male coupler lumen and tapers inwardly toward the distal end of each leg such that an interior diameter of the male coupler lumen decreases in the proximal-to-distal direction; and

an elongate control member received within the delivery tube lumen of the delivery tube and translatable therein proximally and distally, the control member having an outer diameter less than the inner lumen diameter of the internal delivery tube lumen and the internal male coupler lumen but greater than the interior diameter of the male coupler lumen adjacent the distal end of the legs, such that when the control member is advanced distally within the male coupler lumen the control member contacts the internal surfaces of the legs to cause them to flex outwardly,

wherein the male coupler defines a constant outer diameter over its length without the control member contacting the internal surfaces of the legs to cause them to flex outwardly.

2. The apparatus of claim 1, wherein the control member extends distally of the male coupler to support the implant and resist deformation of the implant from a delivery configuration.

3. The apparatus of claim 1, wherein the male coupler is integral with the delivery tube.

4. The apparatus of claim 1, wherein the male coupler and the delivery tube are discrete components secured to one another.

5. The apparatus of claim 4, wherein a proximal portion of the male coupler is received within the internal delivery tube lumen of the delivery tube.

6. The apparatus of claim 5, wherein the legs of the male coupler extend distally of the delivery tube.

7. The apparatus of claim 5, wherein the distal end of the delivery tube comprises a position limiter configured to limit an extent of penetration of the male coupler into a female coupler of the implant.

8. The apparatus of claim 1, wherein the outer diameter of the male coupler is equal to an outer diameter of the delivery tube.

9. The apparatus of claim 1, further comprising a position limiter on an exterior of the delivery tube, the position limiter being configured to limit an extent of penetration of the male coupler into a female coupler of the implant.

10. A system for occluding a hollow anatomical structure, the system comprising:

an occlusive implant including an occluding portion and a tubular female coupler, the female coupler defining a female coupler lumen whose internal diameter increases in the proximal-to-distal direction;

an elongate flexible delivery tube defining a delivery tube lumen and having a distal end comprising a male coupler, the male coupler defining a male coupler lumen and including a plurality of cantilevered flexible legs configured to be received within the female coupler lumen, each of the legs including an internal surface that defines at least a portion of the male coupler lumen; and

an elongate control member received within the delivery tube lumen and translatable therein proximally and distally, the control member having an outer diameter greater than an interior diameter of the male coupler lumen adjacent a distal end of the male coupler lumen, such that when the control member is advanced distally within the male coupler lumen the control member contacts the internal surfaces of the flexible legs to cause the flexible legs to flex outwardly and contact an inner surface of the female coupler lumen to releasably secure the implant to the delivery device,

wherein an outer diameter of the male coupler is constant along its length without the control member contacting the internal surfaces of the flexible legs to cause the flexible legs to flex outwardly.

11. The system of claim 10, wherein the control member extends distally of the male coupler to support the implant and resist deformation of the implant from a delivery configuration.

12. The system of claim 10, wherein the implant is a braided mesh material shaped as a tubular coil.

13. The system of claim 10, wherein each of the legs includes an internal surface that tapers inwardly toward the distal end of each leg.

14. The system of claim 13, wherein a taper angle of the female coupler lumen matches a taper angle of the internal surface of the legs.

15. The system of claim 10, wherein the male coupler is integral with the delivery tube.

16. The system of claim 10, wherein the male coupler and the delivery tube are discrete components secured to one another.

17. The system of claim 10, wherein the outer diameter of the male coupler is equal to an outer diameter of the delivery tube.

18. The system of claim 10, further comprising a position limiter on an exterior of the delivery tube, the position limiter being configured to limit an extent of penetration of the male coupler into the female coupler.

19. The system of claim 10, wherein a proximal portion of the male coupler is received within the lumen of the delivery tube.

20. The system of claim 19, wherein the legs of the male coupler extend distally of the delivery tube.

21. The system of claim 19, wherein a distal end of the delivery tube comprises a position limiter configured to limit an extent of penetration of the male coupler into the female coupler.

22. A method for delivering an occlusive implant to a treatment site in a vessel of a body using an elongate flexible delivery device, the method comprising:

accessing vasculature of the body at an access site remote from the treatment site;

introducing the implant and the delivery device into the vasculature at the access site;

advancing the implant and the delivery device through the vasculature toward the treatment site;

positioning the implant at the treatment site;

expanding the implant to contact an interior wall of the vessel and at least partially occlude the vessel;

disengaging the implant from the delivery device; and

withdrawing the delivery device;

wherein the implant includes a tubular female coupler defining a female coupler lumen, the delivery device includes a distal end comprising a male coupler, and the male coupler is received within the female coupler lumen, the male coupler defining a male coupler lumen therethrough and including a plurality of cantilevered flexible legs extending distally,

wherein disengaging the implant from the delivery device comprises withdrawing an elongate flexible control member received within a lumen of the delivery device and the male coupler lumen, the control member having an outer diameter greater than an interior diameter of the male coupler lumen at a distal end of the male coupler, such that as the control member is withdrawn from the male coupler lumen radially outwardly directed force is released from internal surfaces of the legs to cause the legs to relax and retract radially inwardly, and

wherein an outer diameter of the male coupler is constant along its length when the elongate control member is withdrawn.

23. The method of claim 22, wherein expanding the implant comprises withdrawing an introducer sheath in which the implant is contained and compressed, thereby enabling the implant to self-expand.

24. The method of claim 22, wherein expanding the implant comprises withdrawing the control member from the implant, the control member, prior to its withdrawal, supporting the implant and resisting deformation of the implant from a delivery configuration.

25. The method of claim 22, wherein the implant is a braided mesh material shaped as a tubular coil.

26. The method of claim 22, wherein each of the legs includes an internal surface defining at least a portion of the male coupler lumen that tapers inwardly toward the distal end of each leg.

27. The method of claim 26, wherein the female coupler lumen is tapered and increases in diameter in the proximal-to-distal direction.

28. The method of claim 27, wherein a taper angle of the female coupler lumen matches a taper angle of the internal surface of the legs.

29. The method of claim 22, wherein the male coupler is integral with the delivery device.

30. The method of claim 22, wherein the male coupler and the delivery device are discrete components secured to one another.

31. The method of claim 22, wherein the outer diameter of the male coupler is equal to an outer diameter of the delivery device.

32. The method of claim 22, further comprising a position limiter on an exterior of the delivery device, the position limiter being configured to limit an extent of penetration of the male coupler into the female coupler.

33. The method of claim 22, wherein a proximal portion of the male coupler is received within the lumen of the delivery device.

34. The method of claim 33, wherein the legs of the male coupler extend distally of the delivery device.

35. The method of claim 33, wherein a distal end of the delivery device comprises a position limiter configured to limit an extent of penetration of the male coupler into the female coupler.