Apparatus and set for folding or unfolding a medical implant and method

• US 9,433,502 B2
• Filed: 11/26/2010
• Issued: 09/06/2016
• Est. Priority Date: 11/27/2009
• 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:
  US13/512,324
• Publication Number:
  US 20120277734A1
• Time in Patent Office: 2,111 Days
• Field of Search: 606/108, 606/151, 606/153, 606/200, 606/139, 606/140, 606/141, 606/142, 606/143, 606/146, 606/148, 606/213, 606/232, 606/138, 623/1.11, 623/1.12, 623/1.23, 623/2.11, 623/23.72
• US Class Current: 1/1
• 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 2/2439 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

The present invention relates to an apparatus (100) for folding or unfolding at least one medical implant (300) by using at least one tension thread (11, 11′), wherein the apparatus (100) includes a shaft (1) including a reception area for receiving the implant (300), a tensioning device (19) for altering a shape of the foldable and/or unfoldable implant (300) by means of the tension thread (11, 11′), and a separation device for separating the tension thread (11, 11′) from the implant (300) and/or for cutting through the tension thread (11, 11′). The invention further relates to a set and a method.

Claims

1. An apparatus (100) for folding or unfolding at least one medical implant (300) by using tension threads (11, 11′

), wherein the apparatus (100) comprises;

a shaft (1) comprising a reception area for receiving the implant (300), wherein the shaft comprises at least two lateral shaft apertures (9) on different planes of the shaft through which the tension threads can be led between an interior of the shaft and an exterior of the shaft and wherein the threads are led within an interior of the shaft in a longitudinal direction thereof;

a tensioning device (19) for altering a shape of the implant (300) via the tension threads (11, 11′

), wherein the tensioning device (19) comprises at least one pulling device which is arranged to apply tension on the implant (300) via the tension threads (11, 11′

) to alter the shape of the implant (300), and to reduce the tension applied on the implant (300) from the tension threads (11, 11′

); and

a separation device for separating the tension threads (11, 11′

) from the implant (300), wherein the separation device comprises a cutting device (86) for cutting through the tension threads (11, 11′

), wherein the separation device is part of a sleeve aperture (83) in a wall of a sleeve (81) of the apparatus (100), the sleeve aperture (83) comprising a first recess (83b), in which a first tension thread is guided during use, and a second recess (83c), in which a second tension thread is guided during use, wherein the first recess (83b) and the second recess (83c) are separated by a bar (85) to space the first tension thread and the second tension thread apart from each other and wherein the separation device is disposed within the shaft and is configured to be slidable relative to the shaft (1).

2. An apparatus (100) according to claim 1, wherein the pulling device is arranged and/or provided for interacting with the tension threads (11, 11′

) in order to transfer force or tension, wherein the pulling device and the tension threads (11, 11′

) are intricate with each other.

3. An apparatus (100) according to claim 1, wherein the pulling device comprises at least one pulling thread (17).

4. An apparatus (100) according to claim 3, wherein the tension threads (11, 11′

) and/or the at least one pulling thread (17) constitute a bundle or a plurality of threads or thread elements.

5. An apparatus (100) according to claim 1, wherein the sleeve aperture (83) connects an exterior of the sleeve (81) with an interior of the sleeve (81).

6. An apparatus (100) according to claim 5, wherein the interior of the shaft (1) is permeable or can be passed in at least sections thereof in a longitudinal direction of the shaft (1), wherein the shaft (1) has a wall (3), and wherein tension threads (11, 11′

) for folding and/or unfolding the implant (300) can enter and/or leave one of the at least two shaft apertures, and wherein the sleeve (81) is arranged in the interior (5) or in the exterior (7) of the shaft (1) of the apparatus (100) in a state of use of the apparatus (100) such that tension threads (11, 11′

) can be led through both the shaft (1) and the sleeve (81) from the exterior of the apparatus (100) into an interior of the apparatus (100).

7. An apparatus (100) according to claim 6, wherein recesses (83b, 83c) are arranged in the sleeve (81) such that at least three different openings between an exterior (7) of the shaft (1) and the interior (82) of the sleeve (81) can be established by superposing one of the at least two shaft apertures (9) and the sleeve aperture (83).

8. An apparatus (100) according to claim 5, comprising a pre-tensioning device (87) which is arranged for exerting tension onto the sleeve (81) in at least one state of use.

9. An apparatus (100) according to claim 1, wherein the first recess (83b) comprises a portion (84b) without a cutting device.

10. An apparatus (100) according to claim 1, wherein the first recess (83b) has a first extension in a dimension of the apparatus (100) which differs from a second extension of the second recess (83c) in a same dimension of the apparatus (100).

11. An apparatus (100) according to claim 1, wherein the implant (300) is a stent or a cardiac valve assembly.

12. A set comprising at least one apparatus (100) according to claim 1;

and

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

) for the purpose of being folded and/or unfolded.

13. A method comprising:

using an apparatus (100) according to claim 1 to fold or unfold at least one medical implant (300) by using the tension threads.

14. A method according to claim 13, further comprising:

altering a tension having been applied on the implant (300) via tension threads (11, 11′

) by altering a length of a pulling device branching off the interior (5) of the shaft (1).

15. A method according to claim 13, further comprising:

cutting through tension threads (11, 11′

) via the separation device by inducing, enabling or allowing a relative movement between the shaft (1) and a sleeve (81).