System for deploying a device to a distal location across a diseased vessel

• US 9,545,298 B2
• Filed: 05/09/2014
• Issued: 01/17/2017
• Est. Priority Date: 11/10/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Transaortic Medical, Inc
• Inventors: Ginn, Richard S., Carley, Michael T.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/274,563
• Publication Number:
  US 20140336752A1
• Time in Patent Office: 984 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 606/200
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction coatings A61M2025/0046
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

Configurations are described for assisting execution of a percutaneous procedure while protecting the vascular pathway to the operational theater. One embodiment is directed to a system for deploying a device to a distal location across a diseased vessel, comprising a sheath comprising an expandable distal portion comprising a porous wall defining a lumen therethrough, the distal portion having a collapsed configuration, wherein the sheath has a first cross sectional outer diameter and a first lumen inner diameter, and an expanded configuration, wherein the sheath has a second cross sectional outer diameter and a second lumen inner diameter; wherein in the collapsed configuration, the sheath is configured to be advanced across at least a portion of the diseased vessel to a position adjacent the distal location without substantial size interference between the first cross sectional outer diameter of the sheath and an inner diameter profile of a lumen of the vessel.

Claims

1. A system for deploying a device to a distal location across a diseased vessel comprising:

a sheath comprising an expandable distal portion comprising a porous wall defining a lumen therethrough, the distal portion having a collapsed configuration, wherein the sheath has a first cross sectional outer diameter and a first lumen inner diameter, and an expanded configuration, wherein the sheath has a second cross sectional outer diameter and a second lumen inner diameter;

a removable expansion retention member configured to retain the expandable sheath in the collapsed configuration; and

said expansion retention member comprises a corset and tensile member assembly wherein the tensile member may be tensioned proximally to release the corset and allow expansion to the expanded configuration;

wherein in the collapsed configuration, the sheath is configured to be advanced across at least a portion of the diseased vessel to a position adjacent the distal location without substantial size interference between the first cross sectional outer diameter of the sheath and an inner diameter profile of a lumen of the diseased vessel;

wherein upon positioning the collapsed configuration to the desired position adjacent to the distal location, the sheath may be expanded to the expanded configuration to facilitate passage of one or more relatively large diameter structures through the lumen that are larger in diameter than the first cross sectional outer diameter, the expanded configuration diverting at least a portion of the flow of blood through the diseased vessel across the porous wall of the sheath;

wherein the expandable sheath is self-expanding from the collapsed configuration to the expanded configuration; and

wherein upon completion of passage of the one or more relatively large diameter structures, the sheath may be collapsed back to the collapsed configuration.

2. The system of claim 1, wherein the first lumen inner diameter is equal to between about 0 mm and about 3 mm.

3. The system of claim 1, wherein the second lumen inner diameter is equal to between about 20 mm and about 50 mm.

4. The system of claim 1, further comprising one or more radiopaque markers coupled to the sheath and configured to assist an operator observing fluoroscopy with positioning of the sheath relative to the diseased vessel.

5. The system of claim 1, wherein the porous wall comprises one or more holes created across a sheetlike member.

6. The system of claim 5, wherein the holes have a diameter of about 100 microns.

7. The system of claim 1, wherein the porous wall is configured to filter blood flowing through it to prevent passage of emboli that may be present within the lumen.

8. The system of claim 1, wherein the sheath comprises one or more radiopaque markers located adjacent the porous wall and being configured to allow an operator to visualize relative positioning of the porous wall relative to one or more anatomical features using fluoroscopy.

9. The system of claim 1, further comprising a guidewire inserted through at least a portion of the lumen and configured to assist with guidance of the sheath through the diseased vessel.

10. The system of claim 1, further comprising a balloon dilation probe configured to complete the reconfiguration of the expandable sheath from the collapsed configuration to the expanded configuration.

11. The system of claim 1, wherein the device comprises an implantable prosthesis selected to be passed through the expandable sheath to the distal location across the diseased vessel.

12. The system of claim 1, wherein the relatively large diameter structure comprises a cardiac valve prosthesis.

13. The system of claim 1, wherein the expandable sheath is configured to be twisted longitudinally to form the collapsed configuration, and untwisted longitudinally to form the expanded configuration.

14. The system of claim 1, wherein the sheath comprises a proximal portion having a stiffer structural modulus than the distal portion.

15. The system of claim 1, wherein:

an embolic protection component housed in said expandable sheath and adapted to be moved distally out of said sheath;

said embolic protection component comprising a distal hoop, which is expandable and collapsible and configured to expand into contact with the inner wall of a blood vessel;

said embolic protection component comprising, when moved distally and expanded, a tubular porous mesh having an open distal end and a proximal portion housed in said sheath and a distal portion extending to said hoop with at least one elongated structural member supporting said mesh.

16. The system of claim 15, wherein said distal hoop that is controllably closeable by an operator through tensioning of a manipulation member operatively coupled to the distal hoop.

17. The system of claim 15, wherein the embolic protection component is coupled to a manipulation element which is adapted to cause the embolic protection component to collapse.

18. The system of claim 17, wherein said manipulation element is coupled to said hoop.

19. The system of claim 18, wherein said manipulation element is adapted to exert tension on said hoop.

20. The system of claim 17, wherein collapse of said embolic protection component is effective to capture emboli within said mesh.

21. The system of claim 1, wherein:

said sheath comprises an expandable distal portion comprising a first non-porous region distal to said porous wall, said distal portion having a lumen therethrough, the distal portion having a collapsed configuration, wherein the sheath has a first cross sectional outer diameter and a first lumen inner diameter, and an expanded configuration, wherein the sheath has a second cross sectional outer diameter and a second lumen inner diameter.