APPARATUS FOR OCCLUDING BODY LUMENS

• US 20090018569A1
• Filed: 03/03/2008
• Published: 01/15/2009
• Est. Priority Date: 07/13/2007
• Status: Active Grant

• Current Assignee: Takai Hospital Supply Co., Ltd.
• Original Assignee: Percutaneous Systems Inc.
• Inventors: Hodor, Jennifer, Desai, Rupesh, Yee, Steven, Huang, Alexander L.
• Granted Patent: US 8,475,489 B2
• Time in Patent Office: Days
• 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 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration

Abstract

A luminal occlusion device comprises a tension member, an elongate shaft, and a flat film having an axial receptacle which is received over a distal portion of the tension member. The flat film has proximal and distal ends which are attached to the distal ends of the tension member and the elongate shaft, respectively. Thus, distal advancement of the tension member relative to the shaft will cause the flat film to assume a low profile configuration, while proximal retraction of the tension member relative to the elongate shaft will cause the flat film to assume a foreshortened, compacted configuration. The film usually includes one or more radioopaque markers which help shape the compacted film.

Claims

1. A luminal occlusion device comprising:

a tension member having a proximal end and a distal end;

an elongate shaft having a guide structure along at least a distal portion thereof for receiving the tension member and permitting the tension member to shift between a distally extended position and a proximally retracted position relative to the shaft; and

a flat film having an axial receptacle for receiving a distal portion of the tension member wherein a distal end of the film is attached to a distal location on the tension member and a proximal end of the film is attached to a distal end of the elongate shaft,

wherein proximally translating the tension member relative to the shaft compacts the flat film and distally translating the tension member relative to the shaft stretches the film.

2. A device as in claim 1, wherein the flat film has parallel axial edges spaced apart by a distance in the range from 2 mm to 15 mm.

3. A device as in claim 2, wherein the flat film has a length in the axial direction in the range from 10 mm to 100 mm.

4. A device as in claim 3, wherein prior to compacting, the flat film comprises a polymeric sheet structure having a total thickness in the range from 0.1 mm to 0.5 mm.

5. A device as in claim 1, wherein the flat film comprises at least one radioopaque marker formed on a surface thereof.

6. A device as in claim 5, wherein the flat film comprises at least two radioopaque markers, with one disposed on each side of the axial receptacle.

7. A device as in claim 5, wherein the flat film comprises a plurality of individual markers arranged on each side of the axial receptacle.

8. A device as in claim 7, wherein the radioopaque markers comprise gold foil strips.

9. A device as in claim 6, wherein the flat film includes a first wing portion on one side of the axial receptacle and a second wing portion on the other side of the axial receptacle, wherein a first elongate element is disposed along an outer edge of the first wing and a second elongate element is disposed along an outer edge of the second wing.

10. A device as in claim 6, wherein the first and second elongate elements are radioopaque.

11. A device as in claim 6, wherein the first and second elongate elements bias the flat film radially outward from the axial receptacle.

12. A device as in claim 11, wherein the first and second elongate elements assume a helical configuration as the tension member is proximally translated.

13. A device as in claim 9, wherein the flat film includes a third wing portion aligned with but spaced proximally apart from the first wing portion and a fourth wing portion aligned with but spaced proximally of the second wing portion.

14. A device as in claim 13, wherein the first elongate element is disposed continuously along the outer edges of the first and third wing portions and the second elongate element is disposed continuously along the outer edges of the second and fourth wing portions.

15. A device as in claim 14, wherein the first and second elongate members assume two axially spaced-apart helical configurations as the tension member is proximally translated.

16. A device as in claim 1, further comprising a distal tip extending distally from the distal end of the tension member.

17. A device as in claim 16, wherein the distal tip comprises a polymeric tube which tapers down in the distal direction.

18. A device as in claim 17, wherein the polymeric tube comprises polyurethane having a durometer in the range from 25 D to 55 D.

19. A device as in claim 1, wherein the tension member comprises a solid core wire.

20. A device as in claim 19, wherein the wire comprises stainless steel with a width in the range from 0.2 mm to 0.6 mm.

21. A device as in claim 1, wherein the elongate shaft comprises a polymeric tube having an outside width in the range from 0.5 mm to 1.5 mm and a length in the range from 50 cm to 250 cm.

22. A device as in claim 21, wherein the polymeric tube comprises polyether block amide having a durometer in the range from 50 D to 80 D.

23. A device as in claim 22, wherein at least a portion of the polymeric tube is reinforced.

24. A device as in claim 23, wherein the entire length of the polymeric tube is reinforced with a steel braid.

25. A device as in claim 1, further comprising a handle assembly at the proximal end of the elongate shaft.

26. A device as in claim 25, further comprising a grip at the proximal end of the tension member.

27. A device as in claim 26, wherein the handle is removably attached to the proximal end of the shaft and the grip can be covered by the handle when the tension member is positioned fully distally relative to the shaft.

28. A device as in claim 1, further comprising a detent near the proximal end of the tension member, wherein the detent expands when the tension member is proximally retracted to deploy the film and wherein the expanded detent inhibits inadvertent distal movement of the tension member after deployment.

29. A device as in claim 28, wherein the detent comprises one or more bend in the tension member.

30. A device as in claim 1, further comprising at least one reinforcement element on the flat film, wherein the reinforcement element causes the film to collapse in a high volume configuration as the film is compacted.

31. A device as in claim 30, wherein the reinforcement comprises radioopaque markers.

32. A device as in claim 1, wherein the flat film has one or more slits.

33. A device as in claim 32, wherein the slits are oriented axially to facilitate radial expansion when the film is compacted.

34. A device as in claim 32, wherein the slits are oriented laterally to facilitate stretching as the tension member is distally translated.

35. A device as in claim 1, wherein the flat film is arranged symmetrically on either side of the axial receptacle.

36. A device as in claim 1, wherein the flat film is arranged asymmetrically on either side of the axial receptacle.

37. A device as in claim 1, wherein the flat film has a tapered profile.