Fossa ovalis penetration

• US 10,398,503 B2
• Filed: 10/14/2015
• Issued: 09/03/2019
• Est. Priority Date: 10/14/2015
• Status: Active Grant

• Current Assignee: Transseptal Solutions Ltd.
• Original Assignee: Transseptal Solutions Ltd.
• Inventors: Sapir, Elad, Teichman, Eyal
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Good, Samantha M
• Application Number:
  US14/882,687
• Publication Number:
  US 20170105761A1
• Time in Patent Office: 1,420 Days
• 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 18/1477 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 2025/0095 being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

A method is provided, including transvascularly inserting a guidewire into a right atrium of a subject. Apparatus is provided that includes (a) a catheter, and (b) a hollow needle disposed within a lumen of the catheter, the hollow needle including a proximal portion and a distal portion that is more flexible than the proximal portion. The apparatus is passed into the right atrium by passing the needle over the guidewire. Following the passing of the apparatus into the right atrium, the guidewire is partially withdrawn into the needle, while keeping a distal end of the guidewire within the needle and in a body of the subject. Thereafter, a hole is formed through an interatrial septum of the subject with the needle. Other embodiments are also described.

Claims

1. A method comprising:

transvascularly inserting a guidewire into a right atrium of a subject;

providing an apparatus that includes (a) a catheter and (b) a hollow needle disposed within a lumen of the catheter, the hollow needle including a proximal portion and a distal portion that is more flexible than the proximal portion;

passing the apparatus into the right atrium by passing the needle over the guidewire;

following the passing of the apparatus into the right atrium, partially withdrawing the guidewire into the needle, while keeping a distal end of the guidewire within the needle and in a body of the subject; and

after the partially withdrawing of the guidewire into the needle, forming a hole through an interatrial septum of the subject with the needle.

2. The method according to claim 1, further comprising, after the forming of the hole through the interatrial septum, advancing the guidewire into a left atrium of the subject.

3. The method according to claim 2, further comprising, after the advancing of the guidewire into the left atrium, proximally withdrawing the needle from the right atrium.

4. The method according to claim 3, further comprising, after the proximally withdrawing of the needle from the right atrium, introducing, over the guidewire, a left-side therapeutic delivery system into the left atrium.

5. The method according to claim 4, wherein the proximally withdrawing of the needle from the right atrium comprises leaving the catheter in the right atrium, and wherein the introducing of the left-side therapeutic delivery system comprises introducing the left-side therapeutic delivery system through the catheter.

6. The method according to claim 4,

wherein the method further comprises, before the introducing of the left-side therapeutic delivery system into the left atrium, advancing the catheter distally through the hole into the left atrium, and

wherein the introducing of the left-side therapeutic delivery system into the left atrium comprises advancing the left-side therapeutic delivery system through the catheter into the left atrium.

7. The method according to claim 1, wherein the forming of the hole through the interatrial septum comprises forming the hole through a fossa ovalis of the subject.

8. The method according to claim 1, wherein the forming of the hole through the interatrial septum comprises puncturing the interatrial septum with a sharp distal tip of the needle.

9. The method according to claim 1, wherein the forming of the hole through the interatrial septum comprises applying energy to the interatrial septum with the needle.

10. The method according to claim 1, further comprising, before the forming of the hole through the interatrial septum:

deploying at least one fossa-ovalis-finding loop from a wall of the catheter; and

moving the fossa-ovalis-finding loop along the interatrial septum, until the fossa-ovalis-finding loop contacts a fossa ovalis of the subject.

11. The method according to claim 1, wherein the partially withdrawing of the guidewire comprises partially withdrawing the guidewire a distance of less than 50 cm.

12. The method according to claim 1, wherein the apparatus further includes a fluid-impermeable cover surrounding the distal portion of the needle.

13. The method according to claim 12, further comprising measuring, using a pressure sensor disposed in fluid communication with a proximal end of the needle, a pressure at a distal tip of the needle.

14. The method according to claim 1,

wherein the apparatus further includes a dilator element, which is shaped to define a dilator lumen and to be slidably disposed within the lumen of the catheter,

wherein the needle is slidably disposed within the dilator lumen, and

wherein the method further comprises dilating the hole using the dilator element.

15. The method according to claim 14, further comprising, after the dilating of the hole, advancing the catheter distally through the dilated hole into a left atrium of the subject.

16. The method according to claim 1, wherein the hollow needle further includes a distal-most end portion that is (a) disposed distal to the flexible distal portion and (b) less flexible than the flexible distal portion.

17. The method according to claim 1, wherein the catheter is a puncture-tool catheter, and wherein the passing of the apparatus into the right atrium comprises:

inserting a delivery catheter of a left-side therapeutic delivery system into the right atrium; and

advancing the puncture-tool catheter through the delivery catheter into the right atrium.

18. The method according to claim 17, further comprising, after the forming of the hole:

withdrawing the puncture-tool catheter from the body through the delivery catheter; and

using the delivery catheter to introduce a left-side therapeutic device into a heart.

19. The method according to claim 18,

wherein the apparatus further includes a dilator element, which is shaped to define a dilator lumen and to be slidably disposed within the lumen of the puncture-tool catheter,

wherein the needle is slidably disposed within the dilator lumen,

wherein the method further comprises dilating the hole using the dilator element, and

wherein the using of the delivery catheter to introduce the left-side therapeutic device into the heart comprises:

advancing the delivery catheter over the dilator element while the dilator element is disposed within the hole through the interatrial septum, until a distal end opening of the delivery catheter is disposed in a left atrium; and

after the withdrawing of the puncture-tool catheter from the body through the delivery catheter, using the delivery catheter to introduce the left-side therapeutic device into the left atrium.

20. The method according to claim 1, wherein the distal portion of the hollow needle is helical.