INTRAVASCULAR GUIDEWIRE FILTER SYSTEM FOR PULMONARY EMBOLISM PROTECTION AND EMBOLISM REMOVAL OR MACERATION

• US 20100268264A1
• Filed: 10/27/2008
• Published: 10/21/2010
• Est. Priority Date: 10/26/2007
• Status: Active Grant

• Current Assignee: Surmodics MD, LLC (Surmodics Incorporated)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Prather, Richard, Ansel, Gary, Bonnette, Michael, Ball, Douglas L., Morris, David B., Kozak, Debra M., Weisel, Stephen E., Thor, Eric J.
• Granted Patent: US 9,827,084 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• 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 2/012 Multiple filtering units
• 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 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2230/0097 : Harpoon-shaped
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/004 : differing in coefficient of thermal expansion, e.g. dilation, dilatation
• CPC Class Codes: A61F 2250/0042 : differing in shape-memory transition temperatures, e.g. in martensitic transition temperature, in austenitic transition temperature

Abstract

An intravascular emboli capture and retrieval system for intravascular embolism protection and embolism removal or maceration. Guidewire mounted proximally and distally located multiple opening filters are deployed within the vasculature and used to part, divide and macerate embolic debris and to capture such embolic debris within the confines thereof. A deployable flexible preformed memory shaped capture sleeve is alternatively used to collapse one or more filters and embolic debris therein for subsequent proximal withdrawal from the vasculature.

Claims

1. An intravascular guidewire filter system comprising a manifold having a central elongated tubular body, said central elongated tubular body having a proximal end and a distal end, an elongated flexible delivery tube having a proximal end and a distal end, said proximal end of said elongated flexible delivery tube being fixed within said distal end of said central elongated tubular body, an apertured seal within said proximal end of said central elongated tubular body, a guidewire having a proximal end and a distal end, said guidewire extending through said apertured seal, through said elongated tubular body, and through said elongated flexible delivery tube, a flexible preformed memory shaped distal filter being attached to said guidewire, a flexible preformed memory shaped proximal filter being attached to said guidewire proximal to said distal filter.

2. The intravascular guidewire filter system of claim 1, wherein said proximal filter has a concave basket shaped configuration having a concave shaped side, which proximal filter has said concave shaped side facing in a proximal direction and said distal filter has an angulated circumferential configuration.

3. The intravascular guidewire filter system of claim 2, wherein each of said proximal filter and said distal filter is made from strands of nitinol.

4. An intravascular guidewire filter system comprising a first manifold and a second manifold, each of said manifolds having a central elongated tubular body, each of said central elongated tubular bodies having a proximal end and a distal end, said first manifold being proximal to said second manifold, an apertured sealing element being secured within said proximal end of said central elongated tubular body of said first manifold, an elongated flexible delivery tube having a proximal end and a distal end, said proximal end of said elongated flexible delivery tube being connected through said distal end of said central elongated tubular body of said second manifold, said distal end of said elongated flexible delivery tube extending a predetermined distance beyond said distal end of said central elongated tubular body, an elongated flexible capture positioning tube having a proximal end and a distal end, said proximal end of said elongated flexible capture positioning tube being secured within said distal end of said central elongated tubular body of said first manifold, a guidewire having a proximal end and a distal end, said proximal end of said guidewire extending coaxially through said apertured sealing element, through said central elongated tubular body, through said elongated flexible capture positioning tube, and extendable a predetermined distance beyond said distal end of said elongated flexible capture positioning tube, a first flexible preformed memory shaped distal filter being attached to said guidewire, a second flexible preformed memory shaped proximal filter being attached to said guidewire proximal to said first flexible preformed memory shaped distal filter, an elongated flexible capture sleeve having a proximal end and a distal end, said proximal end of said elongated flexible capture sleeve being attached to said distal end of said elongated flexible capture positioning tube, said elongated flexible capture sleeve being proximal to said proximal filter.

5. The intravascular guidewire filter system of claim 4, wherein said flexible preformed memory shaped proximal and distal filters are similarly constructed, each of said preformed memory shaped proximal and distal filters has an angulated circumferential configuration with a substantial open proximal end and a distal filter end and wherein each of said proximal and distal filters being oriented in the same direction.

6. The intravascular guidewire filter system of claim 5, wherein each of said flexible preformed memory shaped proximal and distal filters is made from multiple strands of nitinol with said substantial open proximal end having large openings and said distal filter end having a plurality of small openings smaller than said large openings.

7. The intravascular guidewire filter system of claim 6, wherein said large and small openings formed by said multiple strands of nitinol are substantially diamond shaped.

8. The intravascular guidewire filter system of claim 7, wherein each of said proximal and distal filters has a proximal tube surrounding and attached to said guidewire and to said proximal end of each of said filters and a distal tube attached to said distal end of each of said filters and surrounding and slideable along said guidewire.

9. The intravascular guidewire filter system of claim 8, wherein said elongated flexible capture sleeve has a flared tubular shape with a memory expanded flared midsection and a memory expanded flared distal section with an increasing diameter greater than said increasing diameter of said memory expanded midsection.

10. The intravascular guidewire filter system of claim 9, wherein said elongated flexible capture sleeve is made from a woven mesh of single nitinol strands and multiple polymer strands.

11. The intravascular guidewire filter system of claim 10, wherein said elongated flexible delivery tube is made from a flexible spiral or woven plastic material.

12. The intravascular guidewire filter system of claim 11, wherein said elongated flexible delivery tube has a hydrophilic coating.

13. The intravascular guidewire filter system of claim 12, wherein a preformed memory shaped fine filter with small orifices therein surrounds and is attached to said distal end of each of said proximal and distal filters.

14. The intravascular guidewire filter system of claim 4, wherein said flexible preformed memory shaped proximal and distal filters are similarly constructed, each of said preformed memory shaped proximal and distal filters has an angulated circumferential configuration with a substantial open end and a filter end and wherein said proximal and distal filters are oriented in an opposing direction to each other.

15. The intravascular guidewire filter system of claim 4, wherein said flexible preformed memory shaped proximal filter has a concave basket shaped configuration having a concave shaped side which proximal filter has said concave shaped side facing in a proximal direction and said flexible preformed memory shaped distal filter has an angulated circumferential configuration.

16. The intravascular guidewire filter system of claim 15, wherein each of said proximal filter and said distal filter is made from strands of nitinol.

17. The intravascular guidewire filter system of claim 16, wherein said nitinol strands of said proximal filter form small openings.

18. The intravascular guidewire filter system of claim 17, wherein said distal filter has a substantial open proximal end and a distal filter end.

19. The intravascular guidewire filter system of claim 18, wherein said substantial open proximal end of said distal filter has substantially large openings and said distal filter end of said distal filter has a plurality of small openings smaller than said substantially large openings.

20. The intravascular guidewire filter system of claim 19, wherein said large and small openings formed by said strands of nitinol are substantially diamond shaped.

21. The intravascular guidewire filter system of claim 19, wherein said small openings in said proximal filter correspond to said plurality of small openings in said distal filter.

22. The intravascular guidewire filter system of claim 16, wherein each of said proximal and distal filters has a proximal tube surrounding and attached to said guidewire and to said proximal end of each of said filters and a distal tube attached to said distal end of each of said filters and surrounding and slideable along said guidewire.

23. The intravascular guidewire filter system of claim 14, wherein each of said flexible preformed memory shaped proximal and distal filters is made from multiple strands of nitinol with said substantial open proximal end having large openings and said distal filter end having a plurality of small openings smaller than said large openings.

24. The intravascular guidewire filter system of claim 23, wherein said large and small openings formed by said multiple strands of nitinol are substantially diamond shaped.

25. The intravascular guidewire filter system of claim 4, wherein said elongated flexible capture sleeve has a flared tubular shape with a memory expanded flared midsection and a memory expanded flared distal section with an increasing diameter greater than said increasing diameter of said memory expanded midsection.

26. The intravascular guidewire filter system of claim 25, wherein said elongated flexible capture sleeve is made from a woven mesh of single nitinol strands and multiple polymer strands.

27. An intravascular guidewire filter system comprising a manifold having a central elongated tubular body, said central elongated tubular body having a proximal end and a distal end, an elongated flexible delivery tube having a proximal end and a distal end, said proximal end of said elongated flexible delivery tube being fixed within said distal end of said central elongated tubular body, an apertured seal within said proximal end of said central elongated tubular body, a guidewire having a proximal end and a distal end, said guidewire extending through said apertured seal, through said elongated tubular body, and through said elongated flexible delivery tube, and two or more flexible preformed memory shaped filters being attached to said guidewire.

28. The intravascular guidewire filter system of claim 27, wherein each of said filters are made from strands of nitinol.

31. The intravascular guidewire filter system of claim 27 wherein each of said filters has a proximal tube surrounding and attached to said guidewire and to a proximal end of each of said filters and a distal tube attached to a distal end of each of said filters and surrounding and slideable along said guidewire.

29. An intravascular guidewire filter system comprising a manifold having a central elongated tubular body, said central elongated tubular body having a proximal end and a distal end, an elongated flexible delivery tube having a proximal end and a distal end, said proximal end of said elongated flexible delivery tube being fixed within said distal end of said central elongated tubular body, an apertured seal within said proximal end of said central elongated tubular body, a guidewire having a proximal end and a distal end, said guidewire extending through said apertured seal, through said elongated tubular body, and through said elongated flexible delivery tube, an elongated flexible capture sleeve having a proximal end and a distal end, said distal end of said elongated flexible capture sleeve being proximal to one or more flexible preformed memory shaped filters being attached to said guidewire.

30. The intravascular guidewire filter system of claim 29, wherein each of said capture sleeve and said filters are made from strands of nitinol.

32. The intravascular guidewire filter system of claim 29, wherein said elongated flexible capture sleeve has a flared tubular shape with a memory expanded flared midsection and a memory expanded flared distal section with an increasing diameter greater than said increasing diameter of said memory expanded midsection.