Vascular device for emboli and thrombi removal and methods of use

• US 8,486,105 B2
• Filed: 07/08/2011
• Issued: 07/16/2013
• Est. Priority Date: 07/30/1999
• Status: Expired due to Fees

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Demond, Jackson F., Khosravi, Farhad, Krolik, Jeff A., Ramee, Stephen, Renati, Richard J., Salahieh, Amr, Young, Kirk Hsueh-Kai
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/178,547
• Publication Number:
  US 20110264135A1
• Time in Patent Office: 739 Days
• Field of Search: 606/159, 606/194, 606/198, 606/200, 604/96.01, 604/104, 604/164.05
• 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 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Abstract

Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device disposed on a guidewire comprises a support hoop disposed from a suspension strut. Alternately, a support hoop having an articulation region may be directly connected to a region proximate the distal end of the guidewire. A blood permeable sac is affixed to the support hoop to form a mouth of the blood permeable sac. The support hoop is disposed obliquely relative to the longitudinal axis of the guidewire and is capable of being properly used in a wide range of vessel diameters. The vascular device collapses during removal to prevent material from escaping from the sac. A delivery sheath and introducer sheath for use with the vascular device of the present invention are also provided.

Claims

1. Apparatus suitable for filtering emboli, comprising:

a guide wire having a proximal region, a distal region, and a floppy distal tip;

a filter attached to the distal region of the guide wire, the filter having a contracted configuration and an expanded configuration;

wherein the filter includes a support hoop having an articulation region and a blood permeable sac forming a proximal-facing mouth; and

a sheath comprising;

a lumen extending therethrough; and

a distal end having a locking wedge;

wherein the filter is disposed within the lumen of the sheath in the contracted configuration.

2. The apparatus of claim 1, wherein the filter further comprises a spinner tube slidably and rotatably disposed about the guide wire.

3. The apparatus of claim 2, wherein the blood permeable sac is attached along its length to the spinner tube.

4. The apparatus of claim 2, wherein the spinner tube further comprises a nose cone.

5. The apparatus of claim 1, the support hoop further including a first curved region and a second curved region;

wherein the articulation region is disposed between the first curved region and the second curved region.

6. The apparatus of claim 5, wherein first curved region and the second curved region articulate at the articulation region and the support hoop folds to a predetermined shape in the contracted configuration.

7. The apparatus of claim 5, wherein the first curved region opposes the second curved region about the guide wire.

8. The apparatus of claim 7, wherein retracting the sheath relative to the guide wire deploys the filter from the distal end of the sheath.

9. The apparatus of claim 5, wherein the wedge of the locking distal end of the sheath is configured to engage the first curved region and the second curved region when the filter is in the expanded configuration, thereby inhibiting articulation of the support hoop and maintaining the support hoop in the expanded configuration.

10. The apparatus of claim 1, wherein the support hoop tapers to a minimum thickness at the articulation region.

11. The apparatus of claim 1, wherein the support hoop comprises a super elastic material.

12. Apparatus suitable for filtering emboli, comprising:

an elongated member having a distal region having a longitudinal axis;

a filter frame disposed on the elongated member, the filter frame having a hoop portion at least partially forming a filter mouth and a curved strut portion extending longitudinally in a proximal direction,

wherein the hoop portion includes a reduced thickness articulation region; and

a polymeric blood permeable sac affixed to the hoop portion so that the filter mouth is a proximally facing mouth of the blood permeable sac.

13. The apparatus of claim 12, wherein the curved strut portion includes a first strut curving in a first direction and a second strut curving in a second direction opposite the first direction.

14. The apparatus of claim 12, wherein the curved strut portion is a multi-turn helical suspension strut.

15. The apparatus of claim 12, wherein the apparatus includes a rotation tube mounted between a proximal stop and a distal floppy tip that acts as a stop,

wherein the sac is disposed on the rotation tube.

16. The apparatus of claim 15, further including a nose cone distal of the rotation tube.

17. The apparatus of claim 12, further comprising a second filter frame slideably disposed on the elongated member, the second filter frame having a hoop portion at least partially forming a filter mouth;

and

a polymeric blood permeable sac affixed to the hoop portion.

18. Apparatus suitable for filtering emboli, comprising:

a guidewire having a proximal region and a distal region;

a first support hoop attached to the distal region of the guidewire, the first support hoop having a contracted configuration and an expanded configuration,

wherein the first support hoop forms a mouth for a first blood permeable sac attached thereto;

a second support hoop slideably attached to the guidewire, the second support hoop having a contracted configuration and an expanded configuration,

wherein the second support hoop forms a mouth for a second blood permeable sac attached thereto;

the lumen of the sheath adapted to contain the first support hoop in the contracted configuration as well as the first blood permeable sac; and

a second sheath comprising a lumen adapted to contain the second support hoop in the contracted configuration as well as the second blood permeable sac,

wherein the second support hoop and second blood permeable sac are adapted to be advanced and retracted relative to the guidewire independently of the first support hoop and first blood permeable sac.

19. The apparatus of claim 18, wherein the first support hoop includes first and second curved regions and a reduced thickness articulation region disposed between the first and second curved regions.

20. The apparatus of claim 18, wherein the second support hoop includes first and second curved regions and a reduced thickness articulation region disposed between the first and second curved regions.

21. The apparatus of claim 18, wherein the first sheath is adapted to be removed from the first support hoop and first blood permeable sac independently of the removal of the second support hoop and second blood permeable sac from the second sheath.

22. The apparatus of claim 18, wherein the first support hoop is adapted to expand from the contracted configuration to the expanded configuration upon removal of the first sheath therefrom.

23. The apparatus of claim 18, wherein the second support hoop is adapted to expand from the contracted configuration to the expanded configuration upon removal of the second sheath therefrom.

24. The apparatus of claim 18, wherein the first support hoop is attached to the distal region of the guidewire by a support tube adapted to slide and rotate about the guidewire.