Medical implant maintaining gaps upon crimping, method and delivery device

• US 10,292,843 B2
• Filed: 02/16/2011
• Issued: 05/21/2019
• Est. Priority Date: 02/17/2010
• Status: Active Grant

• Current Assignee: Venus Medtech (Hangzhou), Inc.
• Original Assignee: Venus Medtech (Hangzhou), Inc.
• Inventors: Goetz, Wolfgang, Lim, Hou-Sen
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Knauss, Christian D
• Application Number:
  US13/579,916
• Publication Number:
  US 20130096664A1
• Time in Patent Office: 3,016 Days
• Field of Search: 623 111, 623 112, 623 124, 623 211
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An implant, intended to be detachably fixed or crimped on a portion or an outer surface of a catheter for being delivered to an implantation site, includes a longitudinal axis, or an inner space or inner volume longitudinally extending within the implant, and a radial direction perpendicular to the longitudinal axis, space or volume. The implant includes a first structural element having a first portion, a second structural element having a second portion, and one or more interconnecting elements arranged between the first and the second structural elements. In the implant, the first portion and/or the second portion is/are located less radially as regards the longitudinal axis, inner space, or volume than a third portion of the one or more interconnecting elements.

Claims

1. An implant attachable to a catheter which has an outer surface, the implant having a longitudinal axis and is coaxial with the catheter, the implant having a radial direction perpendicular to the longitudinal axis, and the implant being positioned between a crimped state and an expanded state, the implant comprising:

a first structural element having a first bending portion, the first bending portion having two longitudinal ends located one above another along a direction parallel to the longitudinal axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinal axis;

a second structural element spaced apart from the first structural element along the longitudinal axis, the second structural element having a second bending portion, the second bending portion having two longitudinal ends located one above another along a direction parallel to the longitudinal axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinal axis; and

at least one interconnecting element arranged between the first structural element and the second structural element, and connecting the first bending portion to the second bending portion,

wherein the at least one interconnecting element is disposed generally parallel to the longitudinal axis along an entire length of the at least one interconnecting element, and

wherein in any state of the implant, the curved portion of the first bending portion and the curved portion of the second bending portion are both located radially closer to the longitudinal axis than the interconnecting element.

2. An implant according to claim 1, wherein the at least one interconnecting element comprises at least two equally spaced posts.

3. An implant according to claim 1, wherein the interconnecting element is a mesh.

4. An implant according to claim 1, wherein the at least one interconnecting element is provided more radially as regards to the longitudinal axis, than the curved portion of the first bending portion and/or the curved portion of the second bending portion, when a diameter of the implant is reduced due to external pressure put on the implant.

5. An implant according to claim 4, wherein the state in which the diameter of the implant is reduced due to external pressure put on the implant in a fully crimped state or in a state in which the implant has been crimped or would be crimped upon crimping for being implanted.

6. An implant according to claim 4, wherein a state in which the diameter of the implant is reduced due to external pressure put on the implant is a crimped state of the implant in which at least one of the first and second bending portions contact the outer surface of the catheter.

7. An implant according to claim 1, wherein at least one of the first structural element and the second structural element is a guiding structure for guiding strings for amending a diameter of the implant within a part of a body vessel or a patient heart.

8. An implant according to claim 1, wherein in a crimped state on a catheter there remains a gap between the at least one interconnecting element and an inner surface of a sleeve covering the implant.

9. An implant according to claim 8, wherein the sleeve is located more radially to the longitudinal axis than at least a portion of the first structural element and a portion of the second structural element.

10. An implant according to claim 1, being or comprising a heart valve.

14. The implant of claim 1, wherein the at least one interconnecting element is further configured such that there is a first gap between the interconnecting element and the outer surface of the catheter.

15. The implant of claim 1, wherein a smaller value of a smallest distance between the first bending portion and the longitudinal axis and a smallest distance between the second bending portion and the longitudinal axis is smaller than a distance between the at least one interconnecting element and the longitudinal axis.

11. A method of attaching an implant to a catheter, wherein the implant includes:

a longitudinal axis;

a first structural element having a first bending portion, the first bending portion having two longitudinal ends located one above another along a direction parallel to the longitudinal axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinal axis;

a second structural element spaced apart from the first structural element along the longitudinal axis, the second structural element having a second bending portion, the second bending portion having two longitudinal ends located one above another along a direction parallel to the longitudinal axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinal axis; and

at least one interconnecting element arranged between the first structural element and the second structural element, and connecting the first bending portion to the second bending portion,

the method comprising;

crimping the implant such that there remains a first gap between the at least one interconnecting element and an outer surface of the catheter,

wherein the at least one interconnecting element is disposed generally parallel to the longitudinal axis along an entire length of the at least one interconnecting element, and

wherein in any state of the implant, the curved portion of the first bending portion and the curved portion of the second bending portion are both located radially closer to the longitudinal axis than the interconnecting element.

12. The method of claim 11, further comprising:

covering the crimped implant with a sleeve such that there remains a second gap between the at least one interconnecting element and an inner surface of the sleeve covering the implant.

13. A catheter comprising:

an implant having a longitudinal axis longitudinally extending within the implant, and a radial direction perpendicular to the longitudinal axis, the implant comprising;

a first structural element having a first bending portion, the first bending portion having two longitudinal ends located one above another along a direction parallel to the longitudinal axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinal axis;

a second structural element spaced apart from the first expandable structural element along the longitudinal axis, the second expandable structural element having a second bending portion, the second expandable structural element having two longitudinal ends located one above another along a direction parallel to the longitudinal axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinal axis;

at least one interconnecting element arranged between the first structural element and the second structural element, and connecting the first bending portion to the second bending portion; and

a catheter portion configured to carry the implant,

wherein the at least one interconnecting element is disposed generally parallel to the longitudinal axis along an entire length of the at least one interconnecting element, and

wherein in any state of the implant, the curved portion of the first bending portion and the curved portion of the second bending portion are both located radially closer to the longitudinal axis than the interconnecting element.