Covered self-expanding vascular occlusion device

• US 5,925,060 A
• Filed: 03/13/1998
• Issued: 07/20/1999
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: B. Braun Celsa, Scion Medical Ltd. (Siemens AG)
• Original Assignee: B. Braun Celsa
• Inventors: Forber, Simon J.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Philogene, Pedro
• Application Number:
  US09/042,108
• Time in Patent Office: 494 Days
• Field of Search: 606/1, 606/151, 606/191, 606/198, 606/200, 606/213, 606/194, 604/107, 604/104, 604/105, 623/1, 623/12
• US Class Current: 606/191
• 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 self-expanding vascular occlusion 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 and a film covering at least a portion of the device, wherein the portion of the device covered is at least half of the device.

2. A self-expanding vascular occlusion device, comprising:

(a) a braided wire member;

(b) 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; and

(c) a film covering at least a portion of the device.

3. The device of claim 2, wherein the film is polyethylene.

4. The device of claim 2, wherein the film is a bioresorbable material.

5. The device of claim 2, wherein the film is surface modified.

6. A self-expanding vascular occlusion device, comprising:

a braided wire member;

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; and

the braided wire portion having a conical shape in the relaxed position and a film covering at least a portion of the device.

7. 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; and

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

8. The method of claim 7, 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.

9. The method of claim 8, further comprising the step of:

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

10. The method of claim 9 further comprising the step of:

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

11. The method of claim 10, wherein reinvertion of the film is accomplished by blowing gas into the stretched film.

12. The method of claim 7, 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.

13. The method of claim 12, 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.

14. The method of claim 12, 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.

15. The method of claim 12, further comprising the step of:

(d) removing the covered device from the mandrel.

16. The method of claim 7, further comprising the step of (bl) further tightening the film around the fixtured device.

17. The method of claim 7, further comprising an initial step of fixturing a piece of film.

18. 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 by inserting a contoured pin into the film to stretch the film to substantially conform to the contour of the pin;

(b) removing the pin after the film has been stretched;

(c) fixturing a device to be covered on an end of a mandrel, then inserting the device on the mandrel into the stretched film so that the film covers at least a portion of the device;

(d) further tightening the film around the fixtured device;

(e) separating the covered device the remaining film; and

(f) removing the covered device from the mandrel.

19. A method of making a film-covered vascular occlusion device having 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 method comprising the steps of:

(a) fixturing a piece of film;

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

(c) removing the pin after the film has been stretched;

(d) reinverting the stretched film if it has inverted during removal of the pin;

(e) inserting the device into the shape formed in the film by fixturing a device to be covered on an end of a mandrel, then inserting the mandrel with the device into the stretched film so that the film covers at least a portion of the device;

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

(g) trimming the film to separate the covered device from the remaining film; and

(h) removing the covered device from the mandrel.

20. A method of using a film-covered vascular occlusion device having 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 method comprising the steps of:

(a) installing a covered vascular occlusion device on an introducer, the introducer having an outer tube and an inner member slidable within the outer tube, the inner member having an end which grips an end of the device, the end of the inner member being disposed within a first end of the outer tube of the introducer so that most of the device is held in a relaxed position outside of the outer tube;

(b) sliding the inner member within the outer tube to pull the device inside of the first end of the outer tube, the device moving to a stretched position upon entering the outer tube;

(c) releasing the device from the inner member leaving a majority of the device inside of the outer tube;

(d) installing an end of the outer tube into a first end of a catheter; and

(e) pushing the device from the outer tube, into the catheter, through the catheter and out of a second end of the catheter where the device moves to its relaxed shape upon exiting the catheter.

21. The method of claim 20, wherein step (c) is accomplished by continuing to slide the inner member inside of the outer tube until the inner member has been removed from the outer tube and releases the device when the end of the inner member gripping the device has exited the outer tube, such movement of the inner member thereby moving the device from the first end to a second end of the outer tube and leaving the device disposed at the second end of the outer tube.

22. The method of claim 21, wherein in step (d) the second end of the outer tube is installed in the end of the catheter.

23. A method of using a vascular occlusion device comprising the steps of:

(a) associating a vascular occlusion device with an introducer, the vascular occlusion device having a braided wire member with at least two axially spaced securing members affixed to the braided wire member and a thin film covering a portion of the device; and

(b) operating the introducer to release the vascular occlusion device into a blood vessel of a patient so that the vascular occlusion device is deployed with a radial expanding force on the blood vessel, and whereby the radial expanding force is related to blood flow.