Fossa ovalis penetration using balloons

• US 9,545,265 B2
• Filed: 05/27/2014
• Issued: 01/17/2017
• Est. Priority Date: 04/15/2013
• Status: Expired due to Fees

• Current Assignee: Transseptal Solutions Ltd.
• Original Assignee: Transseptal Solutions Ltd.
• Inventors: Maisano, Francesco, Sapir, Elad, Zipory, Yuval, Teichman, Eyal
• Primary Examiner(s): Miles, Jonathan
• Assistant Examiner(s): OBU, KENDRA NNEAMAKA
• Application Number:
  US14/287,470
• Publication Number:
  US 20140309678A1
• Time in Patent Office: 966 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/348 Means for supporting the trocar against the body or retaining the trocar inside the body
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices

Abstract

Apparatus and methods are described, including apparatus for puncturing a fossa ovalis of a heart. The apparatus comprises a catheter shaped to define a catheter lumen. A puncturing element is slidably disposed within the catheter lumen and configured to (a) be deployed from a distal portion of the catheter, and (b) puncture the fossa ovalis. A balloon is configured to be deployed from the distal portion of the catheter, be radially expanded, and upon being deployed and expanded, facilitate positioning of the puncturing element, by contacting at least a portion of the fossa ovalis. Other applications are also described.

Claims

1. A method for puncturing a fossa ovalis of a heart, the method comprising:

inserting a catheter into a right atrium of the heart;

advancing a distal portion of the catheter toward an interatrial septum of the heart;

deploying a balloon from the distal portion of the catheter;

identifying a puncture site for puncturing the fossa ovalis, in response to a manner in which the balloon contacts the septum; and

using a puncturing element, puncturing the fossa ovalis at the puncture site,

wherein deploying the balloon further comprises deploying a non-compliant balloon, and

wherein deploying the balloon further comprises expanding the balloon by;

distally sliding at least one slider disposed along an outer surface of the catheter, the slider being coupled to a plurality of ribs coupled to a surface of the balloon, and

filling the balloon with fluid.

2. The method according to claim 1, wherein deploying the balloon from the distal portion of the catheter further comprises passing a contrast agent through a filling tube and into the balloon, and wherein the method further comprises using imaging to view the contrast agent during and following the deployment of the balloon.

3. The method according to claim 1, further comprising, while the balloon is in contact with the septum, and before the puncturing of the fossa ovalis, using a stabilization of the catheter provided by the balloon being in contact with the septum to steer the distal portion of the catheter toward the puncture site,

wherein puncturing the fossa ovalis comprises sliding the puncturing element from the distal portion of the catheter.

4. The method according to claim 1, further comprising, while the balloon is in contact with the septum, and before the puncturing of the fossa ovalis, using a stabilization of the catheter provided by the balloon being in contact with the septum to adjust an orientation of the distal portion of the catheter,

wherein puncturing the fossa ovalis comprises sliding the puncturing element:

from the distal portion of the catheter, and

through the fossa ovalis, at an angle with respect to the fossa ovalis that is determined by the orientation of the distal portion of the catheter.

5. The method according to claim 1, wherein the balloon includes an at least partially radiopaque surface thereof, and wherein the method further comprises using fluoroscopic imaging to view the at least partially radiopaque surface during and following the deployment of the balloon.

6. The method according to claim 1, wherein deploying the balloon further comprises deploying the balloon at an internal pressure of 10-70 mmHg.

7. The method according to claim 1, wherein deploying the balloon further comprises deploying the balloon such that a volume thereof is between 0.5 and 4 mL.

8. The method according to claim 1, wherein the balloon covers a distal tip of the catheter.

9. The method according to claim 8, wherein the balloon comprises an inner surface of which is attached to the distal tip of the catheter.

10. The method according to claim 8, further comprising using the puncturing element to puncture the balloon immediately prior to puncturing the fossa ovalis.

11. The method according to claim 1, wherein deploying the balloon further comprises deploying the balloon that contains a contrast agent, and wherein the method further comprises using imaging to view the contrast agent during and following the deployment of the balloon.

12. The method according to claim 1, wherein deploying the balloon further comprises deploying the balloon such that a surface area thereof that is not in contact with the catheter is between 300 and 1250 mm2.

13. The method according to claim 1 wherein deploying the balloon further comprises deploying an annular balloon, shaped to define a hole, the distal portion of the catheter passing through the hole.