Axial lengthening thrombus capture system

• US 9,579,116 B1
• Filed: 08/05/2016
• Issued: 02/28/2017
• Est. Priority Date: 08/06/2015
• Status: Active Grant

• Current Assignee: Vascular Medcure Incorporated (Medtronic Plc)
• Original Assignee: KP Medcure, Inc.
• Inventors: Nguyen, Thanh Van, Nguyen, Duy, Ngo, Tung Hoang
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/230,109
• Publication Number:
  US 20170035445A1
• Time in Patent Office: 207 Days
• US Class Current: 1/1
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00938 hydrophobic
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22081 Treatment of vulnerable plaque
• 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 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• 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

Abstract

Axial lengthening thrombus capture systems and methods can remove materials of interest, including blood clots, from a body region. These can involve the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions.

Claims

1. A clot capture system, comprising:

a first, outer tubular shaft comprising a central lumen, the first outer tubular shaft comprising a proximal portion and a distal portion, the distal portion more radially expandable than the proximal portion;

a second tubular shaft configured to be positioned within the central lumen of the first shaft;

a third tubular shaft configured to be positioned within a central lumen of the second shaft;

a shape memory tubular body comprising a first end, a second end, and an axial length therebetween, the first end having a proximal-facing opening and a ring-shaped capture guide attached to a circumference of the proximal-facing opening, the capture guide operably attached to the second tubular shaft, the second end attached to an outer wall of the third tubular shaft,

wherein the shape memory tubular body is compressed within the central lumen of the second tubular shaft in a first delivery configuration,

wherein the shape memory tubular body is transformable to a second configuration in which the first end and the capture guide are radially expanded but the second end and a majority of the shape memory tubular body remains radially compressed within the central lumen of the second tubular shaft and the second end is positioned proximal to the first end and the shape memory tubular body has a first expanded axial length,

wherein the shape memory tubular body is transformable to a third configuration in which the shape memory tubular body has a second expanded axial length greater than the first expanded axial length, wherein a width of the shape memory tubular body along its second expanded axial length is substantially the same as a width of the shape memory tubular body along its first expanded axial length,

wherein the first tubular shaft is configured to be reversibly coupled with respect to the second tubular shaft in the first delivery configuration and axially movable with respect to the third tubular shaft in the second configuration.

2. The clot capture system of claim 1, wherein the second expanded axial length is at least about 110% of the first axial length.

3. The clot capture system of claim 1, wherein the second expanded axial length is at least about 125% of the first axial length.

4. The clot capture system of claim 1, wherein the shape memory tubular body is porous.

5. The clot capture system of claim 1, wherein the shape memory tubular body comprises an impermeable, non-porous polymer.

6. The clot capture system of claim 1, wherein the shape memory tubular body comprises a semi-permeable porous polymer.

7. The clot capture system of claim 1, wherein the shape memory tubular body comprises nitinol braided, woven, or non-woven mesh.

8. The clot capture system of claim 1, wherein the shape memory tubular body is uncoated.

9. The clot capture system of claim 1, wherein the shape memory tubular body is coated with a thrombogenic agent.

10. The clot capture system of claim 1, wherein the shape memory tubular body is coated with a hydrophilic or hydrophobic agent.

11. The clot capture system of claim 1, wherein the shape memory tubular body comprises nitinol wire.

12. The clot capture system of claim 1, wherein the shape memory tubular body is configured to invert, evert, or roll out with respect to the third tubular shaft.

13. The clot capture system of claim 1, further comprising a control line extending proximally from the capture guide.

14. The clot capture system of claim 1, further comprising a suction element configured to operably connect with the proximal opening of the shape memory tubular body.

15. The clot capture system of claim 14, further comprising a filter collection chamber configured to collect and filter blood obtained from the suction element.

16. The clot capture system of claim 1, further comprising a mechanical thrombectomy element.

17. The clot capture system of claim 16, wherein the mechanical thrombectomy element comprises a macerator.

18. The clot capture system of claim 1, further comprising an expanding guide element configured to receive the capture assembly.

19. The clot capture system of claim 18, wherein the expanding guide element comprises an open funnel distal tip.

20. The clot capture system of claim 19, wherein the open funnel distal tip is porous to allow flow.

21. A clot capture system, comprising:

a first, outer tubular shaft comprising a central lumen;

a second tubular shaft configured to be positioned within the central lumen of the first, outer tubular shaft, the second tubular shaft comprising a proximal portion and a distal portion, the distal portion more radially expandable than the proximal portion;

a third tubular shaft configured to be positioned within a central lumen of the second tubular shaft;

a tubular mesh comprising a first end, a second end, and an axial length therebetween, the first end having a proximal-facing opening and a ring-shaped capture guide attached to a circumference of the proximal-facing opening, the capture guide operably attached to the second tubular shaft, the second end attached to an outer wall of the third tubular shaft,

wherein the tubular mesh is compressed within the central lumen of the second tubular shaft in a delivery configuration,

wherein the tubular mesh is transformable to a second configuration in which the first end and the capture guide is radially expanded but the second end and a majority of the tubular mesh remains radially compressed within the central lumen of the second tubular shaft and the second end is positioned proximal to the first end and the tubular mesh has a first expanded axial length,

wherein the tubular mesh is transformable to a third configuration in which the tubular mesh has a second expanded axial length greater than the first expanded axial length, wherein a width of the tubular mesh along its second expanded axial length is substantially the same as a width of the tubular mesh along its first expanded axial length, wherein the third tubular shaft extends distally through the proximal-facing opening as well as the second axial expanded length of the tubular mesh.

22. A clot capture system, comprising:

a first, outer tubular shaft comprising a central lumen;

a second tubular shaft configured to be positioned within the central lumen of the first, outer tubular shaft, the second tubular shaft comprising a proximal portion and a distal portion, the distal portion more radially expandable than the proximal portion;

a third tubular shaft configured to be positioned within a central lumen of the second tubular shaft;

a shape memory tubular body comprising a first end, a second end, and an axial length therebetween, the first end having a proximal-facing opening and a ring-shaped capture guide attached to a circumference of the proximal-facing opening, the capture guide operably attached to the second tubular shaft via a sleeve circumscribing a portion of the second tubular shaft, the second end attached to an outer wall of the third tubular shaft,

wherein the shape memory tubular body is compressed within the central lumen of the second tubular shaft in a delivery configuration,

wherein the shape memory tubular body is transformable to a second configuration by axial movement of the second tubular shaft with respect to the first tubular shaft, in which the first end and the capture guide is radially expanded but the second end and a segment of the shape memory tubular body remains radially compressed within the central lumen of the second tubular shaft and the second end is positioned proximal to the first end and the shape memory tubular body has a first expanded axial length,

wherein the shape memory tubular body is transformable to a third configuration by movement of the second tubular shaft with respect to the third tubular shaft, in which the shape memory tubular body has a second expanded axial length greater than the first expanded axial length, wherein a width of the shape memory tubular body along its second expanded axial length is substantially the same as a width of the shape memory tubular body along its first expanded axial length, wherein the third tubular shaft extends distally through the proximal-facing opening as well as the second axial expanded length of the shape memory tubular body.

23. The clot capture system of claim 22, wherein the shape memory tubular body is transformable to a fourth configuration by movement of the second tubular shaft with respect to the third tubular shaft, wherein the shape memory tubular body has a third expanded axial length greater than the second expanded axial length, wherein a width of the shape memory tubular body along its third expanded axial length is less than the width of the shape memory tubular body along its second expanded axial length.

24. The clot capture system of claim 22, wherein the sleeve comprises a metal or polymer.

25. The clot capture system of claim 22, wherein the sleeve is at least partially radiotranslucent under fluoroscopy.