Expandable medical implant

• US 10,493,573 B2
• Filed: 10/14/2016
• Issued: 12/03/2019
• 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): Lynch, Robert A
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US15/294,091
• Publication Number:
  US 20170028518A1
• Time in Patent Office: 1,145 Days
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0073 Force-limiting means
• CPC Class Codes: B23P 11/005 by expanding or crimping
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/53709 Overedge assembling means

Abstract

A method for crimping a medical implant includes at least one foldable and/or unfoldable structure on or around or over a portion or outer surface of a catheter or of a catheter tip. No pressure beyond a predetermined pressure is exerted on the structure during and/or after crimping of the implant.

Claims

1. A method for crimping a medical implant on a catheter, the medical implant comprising:

a foldable and unfoldable structure having one or more heart valve leaflets or replacements or substitutes thereof,

a proximal ring and a distal ring, and

at least one interconnecting element for maintaining a distance between the proximal ring and the distal ring of the implant,

wherein the method comprises;

determining a predetermined pressure;

crimping the medical implant on an outer periphery of the catheter in such a way that the catheter is positioned at a longitudinally central axis of the medical implant, and a gap is maintained between the at least one interconnecting element and the outer periphery of the catheter, and the foldable and unfoldable structure is located in the gap;

measuring a pressure exerted on the foldable and unfoldable structure during crimping of the implant; and

terminating crimping of the implant once the measured pressure has reached or exceeded the predetermined pressure; and

wherein in any steps of the method,

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

the distal ring is spaced apart from the proximal ring along the longitudinally central axis, the distal ring having a second bending portion, the second bending portion having two longitudinal ends located one above another along a direction parallel to the longitudinally central axis and a curved portion between the two longitudinal ends, with the curved portion being convex radially inwardly toward the longitudinally central axis;

the at least one interconnecting element is arranged between the proximal ring and the distal ring, and connects the first bending portion to the second bending portion, the at least one interconnecting element being disposed generally parallel to the longitudinally central axis along an entire length of the at least one interconnecting element; and

the curved portion of the first bending portion and the curved portion of the second bending portion are both located radially closer to the longitudinally central axis than the interconnecting element.

2. The method according to claim 1, wherein the predetermined pressure is 0 N per square millimetre, and the method further comprises

terminating crimping of the implant once the measured pressure has reached or exceeded 0 N per square millimetre.

3. The method according to claim 1, wherein the predetermined pressure is 5 N per square millimetre, and the method further comprises

terminating crimping of the implant once the measured pressure has reached or exceeded 5 N per square millimetre.

4. The method according to claim 1, wherein the method further comprises

placing a force sensor in direct contact with the structure before the crimping procedure.

5. A method for crimping a medical implant on a catheter, the medical implant comprising:

a foldable and unfoldable structure having one or more heart valve leaflets or replacements or substitutes thereof,

a proximal ring and a distal ring, and

at least one interconnecting element for maintaining a distance between the proximal ring and the distal ring of the implant,

wherein the method comprises;

determining a predetermined pressure;

crimping the medical implant on an outer periphery of the catheter in such a way that the catheter is positioned at a longitudinally central axis of the medical implant, and a gap is maintained between the at least one interconnecting element and the outer periphery of the catheter, and the foldable and unfoldable structure is located in the gap;

measuring a pressure exerted on the foldable and unfoldable structure during crimping of the implant; and

terminating crimping of the implant once the measured pressure has reached or exceeded the predetermined pressure; and

wherein in any steps of the method,

the proximal ring has a C-shaped first bending portion, the first bending portion having a middle section protruding radially toward the longitudinally central axis;

the distal ring is spaced apart from the proximal ring along the longitudinally central axis, the distal ring having a C-shaped second bending portion, the second bending portion having a middle section protruding radially toward the longitudinally central axis;

the at least one interconnecting element is arranged between the proximal ring and the distal ring, and connects the first bending portion to the second bending portion, the at least one interconnecting element being disposed generally parallel to the longitudinally central axis along an entire length of the at least one interconnecting element; and

the middle section of the first bending portion and the middle section of the second bending portion are both located radially closer to the longitudinally central axis than the interconnecting element.

6. The method according to claim 5, wherein the predetermined pressure is 0 N per square millimetre, and the method further comprises

terminating crimping of the implant once the measured pressure has reached or exceeded 0 N per square millimetre.

7. The method according to claim 5, wherein the predetermined pressure is 5 N per square millimetre, and the method further comprises

terminating crimping of the implant once the measured pressure has reached or exceeded 5 N per square millimetre.

8. The method according to claim 5, wherein the method further comprises placing a force sensor in direct contact with the structure before the crimping procedure.