Mechanical clot treatment device with distal filter

• US 6,066,149 A
• Filed: 09/30/1997
• Issued: 05/23/2000
• Est. Priority Date: 09/30/1997
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Samson, Gene, Carrison, Harold F.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US08/941,514
• Time in Patent Office: 966 Days
• Field of Search: 606/159, 606/194, 606/200, 606/113, 606/114, 606/127, 606/193, 606/195, 604/22, 128/1 R
• US Class Current: 606/159
• 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 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

This 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 proximal cage assembly and a distal filter, preferably a self-expanding cage assembly or other filter component. The various portions of those components are preferably radio-opaque. The proximal end of the proximal cage is typically is affixed to an actuator in such a way as to allow expansion of the cage after deployment. The proximal cage assembly may be used for collecting emboli or for displacing them to allow blood flow to resume, either with or without concurrent clot-dissolving drug treatment. The distal sector, whether a self-expanding cage or fan, is placed distally of the thrombus to collect portions of the thrombus which may loosen during the treatment or removal procedure.

Claims

1. An embolism treatment device comprising a core element, a proximal cage assembly, a distal collector element, and an actuator element:

a. said core element comprising at least an elongated core wire having a distal end and a proximal end and passing through said distal collector element and said proximal cage assembly,

b. said proximal cage assembly having a distal end and a proximal end substantially coaxial to said core element, said proximal cage assembly having a first deployment shape and a second expanded shape, said second expanded shape being different from the first deployment shape, and

c. said distal collector element having a distal end and a proximal end and spaced from and distal of said proximal cage assembly and having a first deployment shape and a second expanded shape, said second expanded shape being different from the first deployment shape, and

d. an actuator element located proximally to said proximal cage assembly and wherein said proximal cage assembly and said distal collector element are each in said respective first deployment shape when said actuator element is in a first position and said proximal cage assembly and said distal collector element are each in said respective second expanded shapes when said actuator element is in a second position.

2. The embolism treatment device of claim 1 wherein said respective proximal cage assembly and said distal collector element first deployment shapes are coaxially adjacent said core wire.

3. The embolism treatment device of claim 1 further comprising a separator element axially separating said distal collector element from said proximal cage assembly.

4. The embolism treatment device of claim 1 wherein said core wire is rotatable.

5. The embolism treatment device of claim 1 wherein said core wire is rotatable with respect to and non-removable from said proximal cage assembly.

6. The embolism treatment device of claim 1 wherein said core wire is axially movable within said distal collector element and said proximal cage assembly.

7. The embolism treatment device of claim 1 wherein the distal collector element and said proximal cage assembly are self deploying when said actuator element moves from said first position to said second position.

8. The embolism device of claim 1 wherein the distal collector element and the proximal cage assembly are self-collapsing when said actuator element moves from said second position to said first position.

9. The embolism treatment device of claim 1 wherein at least one of the said distal collector element and said proximal cage assembly is comprised of elongated elements comprising a super-elastic alloy.

10. The embolism treatment device of claim 9 wherein a minor number of said distal collector element and said proximal cage assembly elongated elements comprise stainless steel.

11. The embolism treatment device of claim 9 wherein a minor number of said distal collector element and said proximal cage assembly elongated elements comprise a radio-opaque material.

12. The embolism treatment device of claim 1 wherein the core element comprises a core wire having an external and fixedly attached braid.

13. The embolism treatment device of claim 1 wherein at least the proximal cage assembly and the distal collector element are radio-opaque under fluoroscopy.

14. The embolism treatment device of claim 13 wherein said at least proximal cage assembly and distal collector element are comprised of members selected from the group consisting of wires and ribbons covered by a radio-opaque covering.

15. The embolism treatment device of claim 13 wherein the radio-opaque covering comprises radio-opaque wire wrapped around said members.

16. The embolism treatment device of claim 1 wherein the core element comprises a tubular member fixedly attached to the proximal cage assembly and a removable core wire interior to the tubular member.

17. The embolism treatment device of claim 1 wherein said proximal cage assembly comprises a plurality of ribbons woven into a braid.

18. The embolism treatment device of claim 1 wherein said proximal cage assembly comprises a plurality of wires woven into a braid.

19. The embolism treatment device of claim 1 wherein said distal collector element comprises a plurality of ribbons woven into a braid.

20. The embolism treatment device of claim 1 wherein said distal collector element comprises a plurality of wires woven into a braid.

21. The embolism treatment device of claim 1 wherein said distal collector element comprises a plurality of collector elements extending radially from said core wire.

22. The embolism treatment device of claim 1 further comprising a delivery catheter adapted to deliver said proximal cage assembly, and said distal collector element to an embolism in a blood vessel.

23. The embolism treatment device of claim 22 wherein said delivery catheter has a distal end and orifices in said delivery catheter distal end adapted to deliver fluids through said orifices.

24. A method for treating an embolism in a blood vessel comprising the steps of:

1.) introducing into a blood vessel containing an embolism, an embolism treatment device comprising a core element, a proximal cage assembly, a distal collector element, and an actuator element;

a. said core element comprising at least an elongated core wire having a distal end and a proximal end and passing through said distal collector element and said proximal cage assembly,

b. said proximal cage assembly having a distal end and a proximal end substantially coaxial to said core element, said proximal cage assembly having a first deployment shape and a second expanded shape, said second expanded shape being different from the first deployment shape, and

c. said distal collector element having a distal end and a proximal end and spaced from and distal of said proximal cage assembly and having a first deployment shape and a second expanded shape, said second expanded shape being different from the first deployment shape, and

d. an actuator element located proximally to said proximal cage assembly and wherein said proximal cage assembly and said distal collector element are each in said respective first deployment shapes when said actuator element is in a first position and said proximal cage assembly and said distal collector element are each in said respective second expanded shapes when said actuator element is in a second position,

2.) passing said distal collector element past said embolism in said vessel and generally aligning said proximal cage assembly with said embolism, and

3.) moving said actuator element from said first position to said second position and expanding said distal collector element and said proximal cage assembly respectively to said second expanded shapes.

25. The method of claim 24 further comprising the step of introducing a thrombolytic agent proximally of said embolism.

26. The method of claim 24 further comprising the step of withdrawing said embolism treatment device into said delivery catheter.

27. The method of claim 24 further comprising the steps moving said actuator element from said second position to said first position and collapsing using said distal collector element and said proximal cage assembly respectively to said first shapes and withdrawing said embolism treatment device into said delivery catheter.