Mechanical clot treatment device

• US 5,972,019 A
• Filed: 06/05/1997
• Issued: 10/26/1999
• Est. Priority Date: 07/25/1996
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Wong, Rose Y., Nguyen, Kim, Engelson, Erik T., Samson, Gene
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/869,346
• Time in Patent Office: 873 Days
• Field of Search: 606/200, 606/180, 606/170, 606/159, 604/107, 604/108, 604/104, 604/105, 604/106
• US Class Current: 606/200
• 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

This is a medical device. In particular, it is a surgical device usually delivered through an intravascular catheter. It may be used in several ways. It may, for instance, be used to open a clear passageway adjacent thrombus to allow both blood and medication to bypass the clot. It may be used to pierce and to remove thrombus. These thrombus are often found in tortuous vasculature. The device includes several sections. The device has a core element, typically a core wire. Placed around the distal end of the core element is a collapsible but preferably self expanding cage assembly. The cage assembly is preferably radio-opaque. The proximal end of the cage is typically is affixed to an actuator in such a way as to allow expansion of the cage after deployment. The cage assembly may have a generally conical distal or "trailing" portion when expanded and also a proximal section. The cage assembly may be used for collecting emboli or for displacing them to allow blood flow to resume. The proximal section may have various uses, e.g., for centering the collector assembly in the vascular lumen or for gathering larger amounts of the targeted clot or to act as a passageway for fluid flow. The assembly further may have an actuator which permits or causes the collector assembly to expand after deployment.

Claims

1. An embolism treatment device comprising a core element and a cage assembly:

a. said core element having a distal end and a proximal end and comprising at least a rotatable core wire adapted to pass through, to be rotatable with respect to, and to be non-removable from said cage assembly, and

b. said cage assembly having a distal end and a proximal end, and comprising a super-elastic alloy braid substantially coaxial to said core element, said cage assembly coaxial to said core element and having a first deployment shape and a second larger expanded shape, said second larger expanded shape being different from the first deployment shape, and said cage assembly distal end being rotatably attached to said rotatable core wire.

2. The embolism treatment device of claim 1 wherein said first deployment shape is coaxially adjacent said core element.

3. The embolism treatment device of claim 1 further comprising an actuator element connected proximally to said cage assembly and wherein said cage assembly has a first deployment shape adjacent said core element when said actuator element is in a first deployment position and said second expanded shape when said actuator element is in a second deployment position.

4. The embolism treatment device of claim 1 wherein the cage assembly second expanded shape comprises a cylindrical section between said distal end and said proximal end.

5. The embolism treatment device of claim 1 wherein said cage assembly is radio-opaque under fluoroscopy.

6. The embolism treatment device of claim 5 wherein said superelastic alloy braid is comprised of a member selected from the group consisting of wires and ribbons covered by a radio-opaque covering.

7. The embolism treatment device of claim 6 wherein the radio-opaque covering comprises radio-opaque wire wrapped around said braid members.

8. The embolism treatment device of claim 1 wherein the braid is relatively more tightly woven distally.

9. The embolism treatment device of claim 8 wherein the braid is relatively less tightly wound proximally.

10. The embolism treatment device of claim 1 wherein the cage assembly is braided proximally.

11. The embolism treatment device of claim 1 wherein the cage assembly is not braided proximally.

12. The embolism treatment device of claim 1 wherein the cage assembly is self deploying.

13. The embolism treatment device of claim 1 wherein the cage assembly has a decreasing radius distally.

14. The embolism treatment device of claim 1 wherein the core element further comprises a helically wound radio-opaque coil fixedly attached to said rotatable core wire distally of the cage element.

15. The embolism treatment device of claim 1 wherein the cage assembly comprises a nickel-titanium alloy.

16. The embolism treatment device of claim 1 wherein the cage assembly comprises a minor number of ribbons comprised of radio-opaque alloys.

17. The embolism treatment device of claim 2 wherein the actuator comprises a tubular member fixedly attached to the cage assembly.

18. The embolism treatment device of claim 17 wherein said tubular member further comprises a braid.

19. The embolism treatment device of claim 18 wherein said tubular element braid comprises a super-elastic alloy.

20. The embolism treatment device of claim 17 wherein said tubular member further has an inner lumen and an outer surface and has at least one fluid flow orifice from said inner lumen to said outer surface.

21. An embolism treatment device comprising:

(a) a core wire element having a distal end and a proximal end and a longitudinal axis;

(b) a cage assembly comprising at least one spirally wound, metallic member having a distal end and a proximal end, wherein said cage assembly is generally coaxial to said core wire element and wherein said distal end of said cage assembly is fixedly attached to said core wire element;

(c) an actuator fixedly attached to said proximal end of said spirally wound metallic member; and

(d) a radiopaque tip fixedly attached to said core wire element distally of said cage assembly,

wherein said cage assembly has a first deployment shape when said actuator is in a first deployment position and a second larger expanded shape different from the first deployment shape when said actuator is in a second deployment position.

22. The embolism treatment device of claim 21 wherein said cage assembly is fixedly attached to said core element distally.

23. The embolism treatment device of claim 21 wherein said first deployment shape is adjacent said core wire element.

24. The embolism treatment device of claim 21 wherein said second expanded shape comprises a trailing conical collector section.

25. The embolism treatment device of claim 21 wherein the cage assembly further comprises a cylindrical section proximally of said distal end.

26. The embolism treatment device of claim 21 wherein the cage assembly comprises at least two spirally wound superelastic alloy members selected from the group consisting of ribbons and wires, said members being wound respectively clockwise and counter-clockwise about the axis of the core wire element.

27. The embolism treatment device of claim 21 wherein the cage assembly comprises a plurality of ribbons woven into a braid.

28. The embolism treatment device of claim 21 wherein the cage assembly is self deploying.

29. The embolism treatment device of claim 21 wherein the cage assembly comprises a nickel-titanium alloy.

30. The embolism treatment device of claim 21 wherein the cage assembly is contained in a first deployment shape by an electrolytically severable band.

31. The embolism treatment device of claim 30 wherein the actuator comprises a tubular member fixedly attached to the cage assembly.

32. The embolism treatment device of claim 21 wherein the core element further comprises a spring element adapted to deploy said cage assembly to said second shape.

33. The embolism treatment device of claim 21 wherein said cage assembly is radio-opaque under fluoroscopy.

34. The embolism treatment device of claim 21 wherein said spirally wound metallic member is selected from the group consisting of wires and ribbons covered by a radio-opaque covering.

35. The embolism treatment device of claim 34 wherein the radio-opaque covering comprises radio-opaque wire wrapped around said spirally wound metallic member.