Intravascular guidewire filter system for pulmonary embolism protection and embolism removal or maceration

• US 9,827,084 B2
• Filed: 10/27/2008
• Issued: 11/28/2017
• Est. Priority Date: 10/26/2007
• Status: Active Grant

• Current Assignee: Surmodics MD, LLC (Surmodics Incorporated)
• Original Assignee: Embolitech LLC
• Inventors: Bonnette, Michael, Prather, Richard, Thor, Eric J., Weisel, Stephen E., Ball, Douglas L., Morris, David B., Kozak, Debra M., Ansel, Gary
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): OBU, KENDRA NNEAMAKA
• Application Number:
  US12/738,702
• Publication Number:
  US 20100268264A1
• Time in Patent Office: 3,319 Days
• Field of Search: 606191-192, 606194, 606200, 623 111, 623 123
• 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 for prostheses A61F2210/0014
• 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 delivery tube;

a positioning tube having a proximal end and a distal end;

a flexible capture sleeve having an expanded conformation and an unexpanded conformation and a proximal end and a distal end, said proximal end of said flexible capture sleeve is attached to said distal end of said positioning tube, the flexible capture sleeve being constructed of a woven mesh;

a guidewire having a proximal end and a distal end; and

at least two flexible preformed memory shaped filters attached to said guidewire, wherein said delivery tube, said flexible capture sleeve, and said guidewire form a telescopic system, and wherein distal progressive distal positioning of the delivery tube forcibly compresses the flexible capture sleeve, an underlying proximal filter and embolic debris which has been captured within the proximal filter, thereby dividing and macerating the embolic debris.

2. The intravascular guidewire filter system of claim 1, further comprising a first and second flexible preformed memory shaped filters attached to said guidewire, wherein said first flexible preformed memory shaped filter is attached to said guidewire proximal to said second flexible preformed memory shaped filter.

3. The intravascular guidewire filter system of claim 1, wherein said guidewire is slideable within said flexible capture sleeve and said flexible capture sleeve is slideable within said delivery tube.

4. The intravascular guidewire filter system of claim 1, said delivery tube, said flexible capture sleeve, and said guidewire are selectively telescopic.

5. The intravascular guidewire filter system of claim 1, wherein each of said flexible preformed memory shaped filters have an angulated circumferential configuration with a substantial open proximal end and a distal filter end.

6. The intravascular guidewire filter system of claim 5, wherein each of said flexible preformed memory shaped filters are configured with said substantial open proximal end having large openings and said distal filter end having a plurality of openings smaller than said large openings.

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

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

9. The intravascular guidewire filter system of claim 1, wherein said 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 1, wherein the woven mesh consists of single nitinol strands and multiple polymer strands.

11. The intravascular guidewire filter system of claim 1, wherein the woven mesh comprises multiple polymer strands.

12. The intravascular guidewire filter system of claim 1, wherein the flexible capture sleeve has a flared midsection and a flared distal section wherein the degree of flare of the flared distal section exceeds the degree of flare of the flared midsection in order to readily accommodate entry of embolic debris or a filter into the capture sleeve.

13. The intravascular guidewire filter system of claim 1, wherein the woven mesh consists of single nitinol strands and multiple polymer strands, and wherein a distal annular edge of the flexible capture sleeve is prevented from fraying by melting the ends of the polymer strands.

14. The intravascular guidewire filter system of claim 1, wherein a proximal portion of the flexible capture sleeve has a substantially constant diameter.

15. The intravascular guidewire filter system of claim 1, wherein the flexible capture sleeve has a flared distal section, a flared midsection, and a proximal section, and the degree of flare of the flared midsection is less than the degree of flare of the flared distal section and the proximal section has a substantially constant diameter so that reduction of the flare of each capture sleeve section beneficially resists proximal movement of an impinging large piece of embolic debris.

16. An intravascular guidewire filter system comprising,

a delivery tube;

a positioning tube having a proximal end and a distal end;

a flexible capture sleeve having an expanded conformation and an unexpanded conformation and a proximal end and a distal end, said proximal end of said flexible capture sleeve is attached to said distal end of said positioning tube, the flexible capture sleeve being constructed of a woven mesh;

a guidewire having a proximal end and a distal end; and

at least two flexible preformed memory shaped filters attached to said guidewire, wherein said delivery tube, said flexible capture sleeve, and said guidewire form a telescopic system, and wherein distal progressive distal positioning of the delivery tube forcibly compresses the flexible capture sleeve, an underlying proximal filter and embolic debris which has been captured within the proximal filter, thereby elongating the embolic debris.