METHODS, SYSTEMS, AND DEVICES FOR DEPLOYING AN EMBOLIC PROTECTION FILTER

• US 20100241156A1
• Filed: 06/04/2010
• Published: 09/23/2010
• Est. Priority Date: 07/02/2001
• Status: Abandoned Application

• Current Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Edmiston, Daryl R., Linder, Richard J., Johnson, Steven W.
• Application Number:
  US12/793,858
• Publication Number:
  US 20100241156A1
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/015 Stop means therefor
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility

Abstract

A filter device is adapted to function as a guidewire, an exchange guidewire, and provide embolic protection during a procedure. The filter device includes a filter assembly that is either integral with or coupled to a guide member. The filter assembly includes a plurality of struts that expand outwardly to deploy a filter that collects or captures material flowing along the blood vessel within which the filter device is deployed. The plurality of struts are constrained by a restraining member or mechanism that prevents the plurality of struts from expanding or extending outwardly to deploy the filter. Cooperating with the restraining member or mechanism is an actuating assembly that is adapted to release the restraining member or mechanism and enable the filter to be deployed from the guide member. A capture catheter is cooperates with the filter device and substantially surrounds the filter during removal of the filter device.

Claims

1. A medical device for use in a body, comprising:

an elongate member having a distal end and a proximal end;

an expandable therapeutic portion of the medical device disposed on the elongate member, said therapeutic portion having an expanded configuration and a contracted configuration where the therapeutic portion is biased to the expanded configuration;

a releasable restraining member, fixedly attached to the therapeutic portion of the medical device, having a first configuration where the releasable restraining member is in a generally tubular configuration having a first lateral section abutting a second lateral section and where at least a portion of the releasable restraining member that includes the first and second sections is disposed about the therapeutic portion and applies a restraining force to the therapeutic portion to restrain the therapeutic portion in the contracted configuration and a second configuration that permits the therapeutic portion to expand to the expanded configuration in which the releasable restraining member remains fixedly attached to a portion of the therapeutic device and where the first section is spaced away from the second section; and

at least one actuating member configured to release the releasable restraining member from the first configuration to the second configuration, where at least a portion of the actuating member is disposed between the first and second sections.

2. The medical device of claim 1 wherein the actuating member is at least partially interwoven with the releasable restraining member.

3. The medical device of claim 1 wherein the releasable restraining member has a preferential separation region between the first and second sections.

4. The medical device of claim 3 wherein said at least one actuation member cooperates with said preferential separation region and is adapted to preferentially separate said releasable restraining member at said preferential separation region.

5. The medical device of claim 1 wherein said releasable restraining member includes a plurality of apertures adapted to receive a actuating member.

6. The medical device of claim 1 wherein said releasable restraining member comprises a first end and a second end, each of said first end and second end comprising one or more of said plurality of apertures.

7. The medical device of claim 6 wherein said apertures in said first end and said second end alternately receive said actuating member to apply said restraining force against the therapeutic portion.

8. The medical device of claim 7, wherein said actuating member is adapted to be removed from said plurality of apertures to allow the therapeutic portion to expand into the expanded configuration.

9. The medical device of claim 1 wherein said actuating member is stitched through the releasable restraining member.

10. The medical device of claim 1, wherein said releasable restraining member comprises a first end and a second end, each of said first end and said second end comprising a plurality of extensions.

11. The medical device of claim 10, wherein one or more extensions of said plurality of extensions on said first end are offset from one or more extensions of said plurality of extensions on said second end.

12. The medical device of claim 10, wherein each of said plurality of extensions are folded to form an channel through which said at least one actuating member is disposed to apply the restraining force against the therapeutic portion.

13. The medical device of claim 1, wherein said releasable restraining member further comprises a plurality of hoops, each of said plurality of hoops being adapted to receive said at least one actuating member.

14. The medical device of claim 1, wherein said first section and said section being maintained substantially together in the first configuration by stitching said at least one actuating member through said releasable restraining member substantially at said first section and said second section.

15. A method for releasing a plurality of struts of a filter device during a procedure, comprising:

positioning a medical device in a vasculature of a patient, distal of a portion of a blood vessel to be accessed during a procedure, to collect emboli, the filter device comprising;

a therapeutic portion disposed on the elongate member having an expanded configuration and a contracted configuration where the therapeutic portion is biased to the expanded configuration;

a releasable restraining member having a first configuration where the releasable restraining member is in a generally tubular configuration having a first section abutting a second section and where at least a portion of the releasable restraining member that includes the first and second sections is disposed about the therapeutic portion and applies a restraining force to the therapeutic portion to restrain the therapeutic portion in the contracted configuration and a second configuration that permits the therapeutic portion to expand to the expanded configuration and where the first section is spaced away from the second section; and

actuating an actuating member at least partially interwoven through at least a portion of said restraining member, wherein actuating said actuating member in a proximal direction releases said therapeutic portion, wherein said therapeutic portion and said actuating member are removed from the blood vessel.

16. The method as recited in claim 15, wherein actuating said actuating member comprises moving said actuating member in a proximal direction.

17. The method as recited in claim 15, wherein actuating said actuating member further comprises moving said actuating member in a proximal direction to remove said actuating member from cooperating with said releasable restraining member.

18. A medical device comprising:

a guide member having a proximal end, a distal end, and a lumen extending therebetween, the distal end of the guide member including an outer diameter having a step configuration;

a filter assembly disposed adjacent to the distal end of the guide member, the filter assembly having an expanded configuration and a contracted configuration;

a sheath having a proximal end, a distal end, and a lumen therebetween, the sheath coupled to the step configuration of the guide member;

a securing member for securing the sheath to the guide member;

one or more grooves extending entirely or partially through the distal end of the guide member and/or sheath, wherein the one or more grooves provide flexibility to the distal end of the medical device.

19. A medical device comprising:

a guide member having a proximal end, a distal end, and a lumen extending therebetween;

a filter assembly disposed adjacent to the distal end of the guide member, the filter assembly having an expanded configuration and a contracted configuration, the filter assembly including a filter and a plurality of struts, wherein the filter includes a proximal portion, an intermediate portion, and a distal portion, wherein the proximal portion is attached to the plurality of struts, wherein the intermediate portion and the distal portion of the filter are configured to float freely when deployed in a vessel; and

an actuator member for actuating the filter assembly between the expanded configuration and the contracted configuration, wherein the plurality of struts extend from the proximal portion of the filter to the actuator member.

20. A medical device comprising:

a guide member having a proximal end, a distal end, and a lumen extending therebetween;

a filter assembly disposed adjacent to the distal end of the guide member, the filter assembly having an expanded configuration and a contracted configuration, the filter assembly including a filter and a plurality of struts, wherein the plurality of struts bias the filter assembly to the expanded configuration; and

a capture member including a proximal end, a distal end, and a lumen therebetween, wherein the lumen of the capture mechanism is configured to pass over the guide member, wherein the distal end of the capture member is configured to engage the plurality of struts and, when moved distally, radially compress the plurality of struts to actuate the filter assembly from the expanded configuration to the contracted configuration.

21. The medical device of claim 20 wherein the capture member includes a radiopaque marker adjacent to the distal end and a locking mechanism adjacent to the proximal end, the locking mechanism configured to engage the proximal end of the guide member.

22. A medical device comprising:

a guide member having a proximal end, a distal end, and a lumen extending therebetween;

a filter assembly disposed adjacent to the distal end of the guide member, the filter assembly having an expanded configuration and a contracted configuration, the filter assembly including a filter and a plurality of struts;

wherein at least one of the plurality of struts is biased towards a longitudinal axis of the guide member and at least a second of the plurality of struts biased away from the longitudinal axis of the guide member; and

wherein the at least one of the plurality of struts that biased towards the longitudinal axis of the guide member includes a coil disposed about at least a portion of the strut.

23. A medical device comprising:

a guide member having a proximal end, a distal end, and a lumen extending therebetween;

a filter assembly disposed adjacent to the distal end of the guide member, the filter assembly having an expanded configuration and a contracted configuration, the filter assembly including a filter and a plurality of struts;

a core member disposed through at least a portion of the lumen of the guide member and extending distally of the distal end of the guide member, the filter including an aperture therein and the core member extending through the aperture of the filter and secured thereto; and

a coil disposed about at least a portion of the core member.

24. A medical device comprising:

a guide member having a proximal end, a distal end, and a lumen extending therebetween;

a filter assembly disposed adjacent to the distal end of the guide member, the filter assembly having an expanded configuration and a contracted configuration, the filter assembly including a filter, a plurality of struts, and a spring member, wherein the spring member includes a coil-type configuration and is biased to actuate the actuate the filter assembly to the expanded configuration.

25. A medical device deployment system comprising:

An elongate member having a distal end and a proximal end;

an expandable therapeutic medical device fixedly attached to the distal end of the elongate member, said expandable therapeutic medical device having an expanded configuration and a contracted configuration wherein the therapeutic device is biased to the expanded configuration;

a restraining member fixedly attached to a portion of the medical device, said restraining member comprising first and second lateral sections; and

at least one actuating member,

wherein the restraining member fixedly attached to a portion of the medical device has a first generally tubular configuration in which the first and second lateral sections surround at least a portion of the therapeutic portion of the medical device and apply a restraining force to the therapeutic portion of the medical device to restrain the therapeutic portion of the medical device in the contracted configuration and a second configuration in which a portion of the first and second lateral sections of the restraining member are spaced apart allowing the therapeutic portion of the medical device to assume the expanded configuration,

further wherein the actuating member has a first engaged configuration and a second at least partially disengaged configuration, wherein in the engaged configuration, the actuating member joins the first and second lateral sections of the restraining member to maintain them in the first generally tubular configuration and wherein in the second at least partially disengaged configuration, the first and second lateral sections of the restraining member are spaced apart allowing the therapeutic portion of the medical device to assume the expanded configuration.

26. The medical device deployment system of claim 25, wherein the therapeutic portion of the medical device is free of a restraining member which may be removed from the therapeutic portion of the medical device.

27. The medical device deployment system of claim 25, wherein said releasable restraining member includes a plurality of apertures adapted to receive the actuating member.

28. The medical device deployment system of claim 25, wherein the actuating member is at least partially interwoven with the releasable restraining member in the first generally tubular configuration.