Paravalvular leak closure devices and methods

• US 8,801,706 B2
• Filed: 04/30/2010
• Issued: 08/12/2014
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul T., Bergin, Cathleen A., Clague, Cynthia T., Green, Michael M., Hill, Alexander J., Keogh, James R., Laske, Timothy G.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SCOTT, AMANDA L
• Application Number:
  US12/771,031
• Publication Number:
  US 20110054466A1
• Time in Patent Office: 1,565 Days
• Field of Search: 606 32- 45
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00

Abstract

An ablation catheter including an inner tube having a length, a distal end and a longitudinal axis, a plurality of needles extending from the distal end of the inner tube and biased away from the longitudinal axis, an outer sheath slideably moveable relative to the inner tube to surround at least a portion of the length of the inner tube and its extending needles, and a radio frequency energy source electrically connected to the plurality of needles.

Claims

1. An ablation catheter comprising:

an inner tube comprising a length, a distal end having a distal tip, and a longitudinal axis;

a plurality of needles extending from the distal tip of the inner tube and biased away from the longitudinal axis;

an outer sheath slideably moveable relative to the inner tube to surround at least a portion of the length of the inner tube and its extending needles; and

a radio frequency energy source electrically connected to the plurality of needles,

wherein at least one of the needles comprises a distal portion, a proximal portion, and a hinge between the distal and proximal portions, and wherein the distal portion of the needle is biased outwardly relative to the proximal portion of the needle and the longitudinal axis.

2. A method of reducing the size of a space between an implanted device and an adjacent tissue within a patient, the method comprising the steps of:

inserting an outer sheath into the patient until a distal end of the outer sheath is positioned adjacent to the space;

inserting an inner tube into a proximal end of the outer sheath, wherein the inner tube comprises a plurality of needles extending from its distal end;

guiding the inner tube through the outer sheath until the needles extend at least partially from the distal end of the outer sheath;

positioning the tips of the needles adjacent to the tissue and the implanted device;

advancing the needles until they penetrate the tissue and interface with the implanted device;

retracting the needles at least partially relative to the sheath to pull the tissue an dim planted device closer to each other and reduce the size of the space;

applying radio frequency energy to at east one of needles;

retracting the needles from the tissue; and

removing the inner tube and outer sheath from the patient.

3. The method of claim 2, further comprising the step of inserting a guide wire into the patient prior to the step of inserting the outer sheath, and then removing the guide wire after the step of inserting the inner tube.

4. The method of claim 2, wherein the step of inserting the outer sheath into the patient comprises using visualization techniques.

5. The method of claim 2, wherein the step of retracting the needles comprises advancing the outer sheath toward the distal end of the needles to compress the needles toward the longitudinal axis of the inner tube.

6. The method of claim 2, wherein the step of applying radio frequency energy comprises applying the radio frequency energy to at least one of the needles with at least two sequential applications.

7. The method of claim 2, wherein the implanted device comprises a stented valve, wherein the tissue adjacent to the stented valve comprises aortic tissue adjacent an aortic annulus, and wherein the space comprises a paravalvular leak location.

8. The method of claim 2, wherein the steps of inserting the outer sheath and inserting the inner tube into the patient comprise percutaneous insertion through an aorta of the patient.

9. A method of reducing the size of a space between an implanted device and an adjacent tissue within a patient, the method comprising the steps of:

providing an ablation catheter comprising;

an inner tube comprising a distal end and a longitudinal axis;

a plurality of needles extending from the distal end of the inner tube and biased away from the longitudinal axis;

an outer sheath slideably moveable relative to the inner tube to surround at least a portion of the length of the inner tube and its extending needles; and

a radio frequency energy source electrically connected to the plurality of needles;

inserting the outer sheath into the patient until a distal end of outer sheath is positioned adjacent to the space;

inserting the inner tube with extending needles into a proximal end of the outer sheath and guiding the inner tube through the outer sheath until the needles extend at least partially from the distal end of the outer sheath;

positioning the tips of the needles adjacent to the tissue and the implanted device;

advancing the needles until they penetrate the tissue;

retracting the needles at least partially, relative to the sheath to pull the tissue and implanted device closer and reduce the size of the space;

applying radio frequency energy to at least one of needles;

retracting the needles from the tissue; and

removing the catheter from the patient.