Covered self-expanding vascular occlusion device

• US 6,221,086 B1
• Filed: 05/18/1999
• Issued: 04/24/2001
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: Scion Medical Ltd. (Siemens AG)
• Original Assignee: B Braun Medical SAS (B. Braun Holding GmbH & Co. KG)
• Inventors: Forber, Simon J.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/314,237
• Time in Patent Office: 707 Days
• Field of Search: 606/191, 606/108, 606/151, 606/198, 606/194, 606/200, 606/213, 128/898
• US Class Current: 606/151
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

A covered self-expanding vascular occlusion device and a method of making and using the device. The device comprises a braided wire member with at least two axially spaced securing members affixed to the braided wire member and a thin film covering at least half of the device. The braided member can be moved between a larger diameter ball-like shape or conical shape in its relaxed position, and a smaller diameter cylindrical shape in its stretched position. The film covering is applied to the device by first stretching a portion of film to form a shape similar to a portion of a device to be covered by the film, then inserting the device into the shape formed in the film so that the film covers at least half of the device, and trimming the film to separate the covered device from the remaining film. The device is used by installing it on the end of a tubular introducer where it is held in its relaxed position until needed. A sliding member inside of the introducer tube then pulls the device into the tube, moving the device to its stretched position as it does so. The sliding member is pulled out of the tube, releasing the device and leaving it inside of the tube and in its stretched condition. The tube is installed in a catheter and the device pushed from the tube into, through, and out of the catheter where upon exiting the catheter the device then opens to its relaxed condition, lodges in the blood vessel, and immediately and completely occludes the vessel.

Claims

1. A method of making a covered vascular occlusion device, comprising the steps of:

(a) stretching a portion of film to form a shape similar to a portion of a device to be covered by the film, the device comprising a braided wire member and at least first and second securing members affixed to the braided wire member at axially spaced locations, the first and second securing members being moveable axially to shape a portion of the braided wire member intermediate the first and second securing members;

the device being movable between a first stretched position in which the braided wire portion extends in an essentially cylindrical configuration to a maximum axial length and a minimum diameter, and a second relaxed position in which the axial length of the braided wire portion is reduced and its diameter is increased;

(b) inserting the device into the shape formed in the film so that the film covers at least a portion of the device; and

(c) trimming the film to separate the covered device from the remaining film.

2. The method of claim 1, wherein step (a) is accomplished by providing a pin having an upper portion with a tip contoured similar to that of a portion of the device, then pushing the pin into the film to stretch the film to substantially conform to the upper portion of the pin.

3. The method of claim 2, further comprising the step of:

(a1) removing the pin after the film has been stretched.

4. The method of claim 3 further comprising the step of:

(a2) reinverting the stretched film if it has inverted during removal of the pin.

5. The method of claim 4, wherein reinvertion of the film is accomplished by blowing gas into the stretched film.

6. The method of claim 1, wherein step (b) is accomplished by fixturing a device to be covered on an end of a mandrel, then inserting the mandrel with the device into the stretched film.

7. The method of claim 6, wherein the mandrel has a pin which passes through one part of the fixtured device and contacts and supports another part of the fixtured device.

8. The method of claim 6, further comprising the step of

(b1) further inserting the mandrel into the stretched film to further stretch the film tight around at least a portion of the device.

9. The method of claim 6, further comprising the step of:

(d) removing the covered device from the mandrel.

10. The method of claim 6, further comprising the step of:

(b1) further tightening the film around the fixtured device.

11. The method of claim 1, further comprising an initial step of fixturing a piece of film.

12. The method of claim 1, further comprising a step of melting a predetermined portion of the film to the device.

13. The method of claim 12, wherein the step of melting includes the steps of:

(a) pulling the film around an end of the device;

(b) pushing the device through a guide in an extended configuration;

(c) heating the film at a predetermined point, whereby the film melts onto the device at a predetermined region.

14. A method of making a covered vascular occlusion device, comprising the steps of:

(a) stretching a portion of film to form a shape similar to a portion of a device to be covered by the film;

(b) inserting the device into the shape formed in the film so that the film covers at least a portion of the device;

(c) melting a predetermined portion of the film to the device; and

(d) trimming the film to separate the covered device from the remaining film.