SET COMPRISING AN APPARATUS AND A MEDICAL IMPLANT

• US 20160166383A1
• Filed: 07/16/2014
• Published: 06/16/2016
• Est. Priority Date: 07/16/2013
• Status: Active Grant

• Current Assignee: Venus Medtech (Hangzhou), Inc.
• Original Assignee: Transcatheter Technologies Gmbh
• Inventors: Lim, Hou-Sen, GOETZ, Wolfgang
• Granted Patent: US 10,064,720 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2002/9511 the retaining means being filaments or wires

Abstract

The present invention relates to set comprising an apparatus (100) for folding or unfolding at least one medical implant (300) by means of at least one tension thread (11, 11′), wherein the apparatus (100) comprises a shaft (1) and a tensioning device for altering a form or shape of the foldable and/or unfoldable implant (300) by means of the tension thread (11, 11′). In at least one shaft section thereof, the shaft (1) comprises a plurality of individual shaft fibers (13).

Claims

1. A set comprising:

an apparatus (100) for folding or unfolding at least one medical implant (300) by means of at least one tension thread (11, 11′

, 11″

, 11′

″

, 11″

″

); and

at least one implant (300) connected with tension threads (11, 11′

, 11″

, 11′

, 11″

″

) for the purpose of folding and/or unfolding or provided or prepared for being connected with tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

);

wherein the apparatus (100) comprises;

a shaft (1);

a tensioning device for altering a form or shape of the foldable and/or unfoldable implant (300) by means of the tension thread (11, 11′

, 11″

, 11′

″

, 11″

″

); and

wherein the shaft (1) comprises in at least one shaft section thereof a plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

);

the individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) have each at least one shaft opening for passing through the tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

);

wherein the implant (300) comprises;

apertures (a′

, a″

, am and a′

″

) through which tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) are guided;

and wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) which pass through one or more shaft opening(s) of a particular individual shaft fiber (13, 13′

, 13″

, 13′

″

, 13″

″

) also pass together through a common aperture (a′

, a″

, a′

″ and

a″

″

) of the implant (300).

2. The set according to claim 1, wherein, during use of the apparatus (100), shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are always present in bundled form in at least one first section (3) of the shaft section, whereas, in a second section (5), the shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are provided or intended for moving away from each other during use of the apparatus (100).

3. The set according to claim 1, wherein shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) each comprise one or more shaft openings (9) by means of which the one or more tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) can exit from and/or enter into the respective shaft fiber (13, 13′

, 13″

, 13′

″

, 13″

″

).

4. The set according to claim 1, wherein, during a state of use of the apparatus (100), shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are arranged movably in or forth from at least the second section (5) of the shaft (1) independently of each other and/or independently of the position of the implant (300) relative to the apparatus (100) for folding or unfolding.

5. The set according to claim 1, wherein the shaft (1) comprises in at least one section thereof at least one device (19, 21) for bundling individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

).

6. The set according to claim 5, wherein the at least one device (19, 21) for bundling individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) is arranged to be shiftable or movable along a longitudinal extension of the apparatus (100) or is otherwise alterable or manipulatable or engineerable and/or is provided or intended for being used at or on different sections of the apparatus (100) along the longitudinal extension thereof.

7. The set according to claim 1, wherein individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are designed or embodied and intended or provided for moving towards a rim portion (301′

, 301″

, 301′

″

, 301″

″

) of the implant (300) when applying tension onto the implant (300) by means of the tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) extending through these individual shaft fibers (13, 13′

, 13′

, 13′

″

, 13″

″

).

8. The set according to claim 1, wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) exiting from individual shaft fibers (13) are connected with a rim portion (301′

, 301″

, 301′

″

, 301″

″

) of the implant (300) for applying a force onto the rim portion, in particular wherein the rim portion (301′

, 301″

, 301′

″

, 301″

″

) only comprises the entire circumference of the foldable and/or unfoldable periphery of the implant (300).

9. The set according to claim 1, wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) exiting from individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are connected with a rim portion for applying a force onto the rim portion (301′

, 301″

, 301′

″

, 301″

″

) of the implant (300), in particular wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) exiting from at least two individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are connected with the rim portion (301′

, 301″

, 301′

″

, 301″

″

) or parts thereof.

10. The set according to claim 1 designed or embodied as a catheter, in particular a heart catheter, or comprising such a catheter.

11. The set according to claim 1, wherein the implant (300) is a stent or a heart valve arrangement.

12. The set according to claim 1, wherein individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) and the implant (300) are adapted such that, during a process of folding the implant, a first force required for moving the shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) in a section thereof, in particular in a section comprising shaft openings (9) for tensions threads (11, 11′

, 11″

, 11′

″

, 11″

″

), from their longitudinal alignment or for moving them in a direction of radial extension of the implant (300), is lower than a second force required for effecting folding of the implant (300) by means of the tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) connected with the implant (300) and which exit from the shaft openings (9).

13. The set according to claim 2, wherein shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) each comprise one or more shaft openings (9) by means of which the one or more tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) can exit from and/or enter into the respective shaft fiber (13, 13′

, 13″

, 13′

″

, 13″

″

).

14. The set according to claim 2, wherein, during a state of use of the apparatus (100), shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are arranged movably in or forth from at least the second section (5) of the shaft (1) independently of each other and/or independently of the position of the implant (300) relative to the apparatus (100) for folding or unfolding.

15. The set according to claim 2, wherein the shaft (1) comprises in at least one section thereof at least one device (19, 21) for bundling individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

).

16. The set according to claim 2, wherein individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are designed or embodied and intended or provided for moving towards a rim portion (301′

, 301″

, 301′

″

, 301″

″

) of the implant (300) when applying tension onto the implant (300) by means of the tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) extending through these individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

).

17. The set according to claim 2, wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) exiting from individual shaft fibers (13) are connected with a rim portion (301′

, 301″

, 301′

″

, 301″

″

) of the implant (300) for applying a force onto the rim portion, in particular wherein the rim portion (301′

, 301″

, 301′

″

, 301″

″

) only comprises the entire circumference of the foldable and/or unfoldable periphery of the implant (300).

18. The set according to claim 2, wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) exiting from individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are connected with a rim portion for applying a force onto the rim portion (301′

, 301″

, 301′

″

, 301″

″

) of the implant (300), in particular wherein tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) exiting from at least two individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are connected with the rim portion (301′

, 301″

, 301′

″

, 301″

″

) or parts thereof.

19. The set according to claim 2, wherein individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) and the implant (300) are adapted such that, during a process of folding the implant, a first force required for moving the shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) in a section thereof, in particular in a section comprising shaft openings (9) for tensions threads (11, 11′

, 11″

, 11′

″

, 11″

″

), from their longitudinal alignment or for moving them in a direction of radial extension of the implant (300), is lower than a second force required for effecting folding of the implant (300) by means of the tension threads (11, 11′

, 11″

, 11′

″

, 11″

″

) connected with the implant (300) and which exit from the shaft openings (9).

20. The set according to claim 3, wherein, during a state of use of the apparatus (100), shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) of the plurality of individual shaft fibers (13, 13′

, 13″

, 13′

″

, 13″

″

) are arranged movably in or forth from at least the second section (5) of the shaft (1) independently of each other and/or independently of the position of the implant (300) relative to the apparatus (100) for folding or unfolding.