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

• US 9,370,438 B2
• Filed: 11/09/2012
• Issued: 06/21/2016
• Est. Priority Date: 11/10/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Transaortic Medical, Inc
• Inventors: Ginn, Richard S.
• Primary Examiner(s): McEvoy, Thomas
• Application Number:
  US13/673,911
• Publication Number:
  US 20130131787A1
• Time in Patent Office: 1,320 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Configurations are described for assisting in the execution of a percutaneous procedure while protecting the vascular pathway to the operational theater, which may comprise diseased tissue. A railed sheath may be utilized which is controllably expandable and collapsible, and may comprise two or more elongate rail structures configured to assist in the distribution of loads to associated diseased tissue structures, while also contributing to the deployment of percutaneous tools by maintaining alignment of such tools with the railed catheter and associated anatomy.

Claims

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

a. inserting an expandable protective sheath system comprising an obturator assembly removably coupled to the distal portion of a sheath into a diseased vessel at a point of entry, the sheath defining a lumen therethrough, said obturator assembly being configured to pass through said lumen, the sheath having a collapsed configuration, wherein the sheath has a first cross sectional outer diameter defines a first lumen inner diameter, and an expanded configuration, wherein the sheath has a second cross sectional outer diameter and second lumen inner diameter,

said system comprising an embolic capture assembly coupled to said sheath and extending from the distal and of said sheath,

said embolic capture assembly housed in said obturator assembly and comprising rail members which are coupled to a tubular porous filter mesh configured to capture particles in a blood vessel; and

the distal portions of said rail members and said tubular porous filter mesh being coupled to a collapsible hoop structure;

said hoop structure having a collapsed configuration and an expanded configuration, said expanded configuration being dimensioned to engage the walls of a blood vessel; and

b. advancing the sheath in its collapsed configuration through said vessel and 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;

c. causing said obturator assembly to move distally away from said sheath to unhouse said embolic capture assembly,

d. causing said hoop structure to expand into its expanded configuration, whereby said hoop structure comes into contact with the inner wall of said blood vessel lumen and said tubular porous filter mesh is expanded to permit blood to flow throughout and is capable of catching particles in the blood,

e. advancing and deploying a device through said sheath and said embolic capture assembly whereby the sheath is expanded to the expanded configuration with incremental pushing of the device longitudinally through the lumen,

f. causing said hoop structure to collapse after said device passes therethrough thereby capturing such particles as may have been caught by said tubular porous filler mesh, and

g. withdrawing said embolic capture assembly and said sheath from said vessel.

2. The method of claim 1, wherein said obturator assembly has an atraumatic distal tip.

3. The method of claim 1, wherein the diseased vessel is an aorta.

4. The method of claim 1, wherein the device is an implantable prosthesis.

5. The method of claim 4, wherein the implantable prosthesis is a cardiac valve.

6. The method of claim 1, wherein said embolic capture assembly is housed in a jacket removably coupled to said embolic capture assembly with said jacket constraining said hoop structure in its collapsed configuration and further comprising the step of fracturing said jacket to allow said hoop structure to assume its expanded configuration.

7. The method of claim 6 wherein said sheath system comprises a proximal manipulation structure coupled to a tension-applying element which is coupled to said hoop structure and is capable of collapsing said hoop structure when placed under tension to capture particles in said tubular porous filter mesh and further comprising the step of collapsing said hoop structure by pulling on said tension-applying element.

8. The method of claim 6 wherein said obturator jacket is fractured by advancing a device through said tubular porous filter mesh.

9. The method of claim 6, wherein said jacket is fractured by applying tension to a tensile member coupled to the outer surface of said jacket.

10. The method of claim 6, wherein said jacket is fractured by self-expansion of said embolic capture assembly.

11. The method of claim 1, wherein said obturator assembly is withdrawn from said sheath prior to deployment of said device.

12. The method of claim 1, wherein said obturator assembly is moved proximally and removed from said sheath after being moved distally to unhouse said embolic capture assembly.