Release device for releasing a medical implant from a catheter and catheter having a release device and method for clamping an implant therein

• US 10,729,412 B2
• Filed: 01/16/2013
• Issued: 08/04/2020
• Est. Priority Date: 02/16/2012
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Fargahi, Amir
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Xie, Dacheng
• Application Number:
  US13/742,499
• Publication Number:
  US 20130218138A1
• Time in Patent Office: 2,757 Days
• Field of Search: 623 111- 112
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

An embodiment of the invention relates to a release device for releasing a medical implant from an insertion device, in the case of which the implant can be released by way of a relative motion between a first and a second insertion element, comprising a clamping element for clamping the implant in the insertion device, having a proximal end which is distant from a distal end of the insertion device in the state of use, and a distal end which faces the distal end of the insertion device in the state of use, wherein the clamping unit comprises a first component and at least one second component, which clamp the implant there between in the clamped state. The invention further relates to an insertion device comprising such a release device and a method for clamping an implant in an insertion device.

Claims

1. A release device for releasing a medical self-expanding implant from an insertion device, in the case of which the self-expanding implant can be released by way of a relative motion between inner and outer shafts, comprising a clamping unit for clamping the self-expanding implant in the insertion device, having a proximal end which is distant from a distal end of the insertion device, and a clamping unit distal end which faces the distal end of the insertion device, wherein the clamping unit comprises a cup-shaped socket that accepts a proximal end of the self-expanding implant, wherein the cup-shaped socket is configured to withstand radial forces of the self-expanding implant, and a plug connector is fixed on the inner shaft that presses the self-expanding implant against the outer shaft and is separated by an axial distance from the cup-shaped socket, wherein the plug connector and the cup-shaped socket cooperate to clamp the self-expanding implant there between in a clamped state when the self-expanding implant is within the outer shaft and to release the self-expanding implant via proximal retraction of the outer shaft to release a distal end of the self-expanding implant followed by retraction of the inner and outer shafts to release a proximal end of the self-expanding implant.

2. The release device according to claim 1, wherein, in the clamped state, a form-fit connection is defined between the cup-shaped socket and the self-expanding implant to hold the self-expanding implant in position, or friction between the plug connector and the self-expanding implant holds the self-expanding implant in position.

3. The release device according to claim 1, wherein the plug comprises a material having sufficient static friction to hold the self-expanding implant in position in the clamped state and during the proximal retraction of the outer shaft.

4. The release device according to claim 3, wherein the material is selected from the group consisting of polyamide, polyester, polyether block amide, silicone, polyurethane.

5. The release device according to claim 3, wherein the cup-shaped socket comprises a material that is harder than the material of the plug connector and is a material selected from the group consisting of a plastic, perfluoroethylene propylene, high density polyethylene, polytetrafluorethylene, poly-amide, a metal, a ceramic, a rubber or a glass.

6. The release device according to claim 5, wherein the material of the cup-shaped socket is a metal.

7. The release device according to claim 1, wherein the cup-shaped socket and the plug connector each have a passage for receiving the inner shaft.

8. The release device according to claim 1, wherein the cup-shaped socket is disposed on the proximal end of the clamping unit, and the plug connector is disposed on the distal end of the clamping unit.

9. The release device according to claim 1, wherein an inner diameter (Di16) of the cup-shaped socket is wider by a maximum of 0.2 mm than an outer diameter (Da106) of a proximal end of the self-expanding implant in when the self-expanding implant is in a compressed state within the outer shaft.

10. The release device according to claim 1, wherein one or both of the cup-shaped socket and the plug connector have a conical contour.

11. The release device according to claim 1, further comprising a stopper formed as a proximal portion of the cup-shaped socket.

12. The release device according to claim 1, wherein the self-expanding implant lacks fastening elements.

13. The release device of claim 1, wherein the cup-shaped socket comprises a material that is harder than a material of the plug connector.

14. The release device of claim 13, wherein the material of the cup-shaped socket is selected from the group consisting of a polyehteretherketone (PEEK), perfluoroethylene propylene, high density polyethylene, polytetrafluorethylene, polyamide, a metal, a ceramic, a hard rubber or a glass.

15. The release device of claim 14, wherein the material of the plug connector is an elastic or resilient polyether block amide.

16. The release device of claim 1, wherein the plug connector comprises a multilayer material with an inner layer of low friction material selected from the group consisting of perfluoroethylene propylene (FEP), high density polyethylene (HDPE), polytetrafluorethylene (PTFE, Teflon) or hydrophobically/hydrophilically coated polyamides (PA), including PA-6, -6.6, -6.10, -6.12, -11, -12, and an outer layer of high friction material selected from the group consisting of polyamide, polyester, polyether block amide (PEBAX), silicone, polyurethane (PUR), and rubber.