Hydraulic auto crossing balloon/catheter

Patent metadata

Field	Value
Publication number	US-10864354-B2
Application number	US-201715814851-A
Country	US
Kind code	B2
Filing date	Nov 16, 2017
Priority date	Nov 17, 2016
Publication date	Dec 15, 2020
Grant date	Dec 15, 2020

Abstract

Apparatuses, systems, and methods for crossing a tissue region may include a catheter and a tip section arranged therewith. The tip section may be configured to puncture the tissue region and create an opening therein, dilate the opening in the tissue region, and pass through the opening.

First claim

We claim:

1. An apparatus for crossing a tissue region, the apparatus comprising:
a catheter sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal end; and
a tip section arranged at the distal end of the elongate body, the tip section including:
a needle portion arranged at a distal end of the tip section and configured to puncture the tissue region to create an opening therein and retract within the elongate body, and
a balloon arranged proximally of the needle portion having a first section and a second section with at least a portion of the second section being coupled to the tip section, and the balloon is configured to dilate the opening in the tissue region and pass the tip section through the opening with the first section being configured to inflate prior to the second section; and

a hydraulic actuator coupled to a proximal end of the catheter and configured to drive the needle portion through the tissue region and assist in the balloon passing the tip section through the opening.

2. The apparatus of claim 1 , wherein at least a portion of the first section of the balloon comprises a first diameter and the second section of the balloon comprises a second diameter, the first diameter is less than the second diameter.

3. The apparatus of claim 2 , wherein the first section tapers from the second diameter to the first diameter.

4. The apparatus of claim 1 , wherein the balloon is configured to inflate to a substantially spherical shape to dilate the opening in the tissue region.

5. The apparatus of claim 1 , wherein the balloon is configured to asymmetrically inflate.

6. The apparatus of claim 5 , wherein a distal portion of the balloon is configured to inflate at a greater rate than a proximal section of the balloon thereby asymmetrically inflating the balloon.

7. The apparatus of claim 1 , wherein the tip section comprises a first tip section having a first tip section diameter and a second tip section having a second tip section diameter, and the first tip section diameter is less than the second tip section diameter.

8. The apparatus of claim 7 , further comprising a visualization element arranged at a distal end of the second tip section.

9. The apparatus of claim 7 , further comprising a radiopaque marker arranged approximately at a transition between the first tip section and the second tip section.

10. The apparatus of claim 1 , further comprising a hydraulic actuator configured to assist in passing the tip section through the opening in the tissue region.

11. The apparatus of claim 1 , wherein the balloon is configured to concurrently dilate the opening in the tissue region and pass the tip section through the opening.

12. An apparatus for crossing a tissue region, the apparatus comprising:
a catheter sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal end;
a tip section arranged at the distal end of the elongate body, the tip section including:
a needle portion arranged at a distal end of the tip section and configured to puncture the tissue region in a first configuration to create an opening therein and retract within the tip section in a second configuration, and
a balloon arranged proximally of the needle portion and configured to dilate the opening in the tissue region and pass a portion of the tip section through the opening while in a partially inflated configuration; and

a hydraulic actuator coupled to a proximal end of the catheter and configured to drive the needle portion through the tissue region and assist in the balloon passing the tip section through the opening.

13. The apparatus of claim 12 , wherein the balloon is configured to concurrently dilate the opening in the tissue region and pass the portion of the tip section through the opening in the partially inflated configuration and transition to a fully inflated configuration after passing through the opening in the tissue.

14. The apparatus of claim 12 , wherein the tip section comprises a first tip section having a first tip section diameter and a second tip section having a second tip section diameter, and the first tip section diameter is less than the second tip section diameter, and a first section of the balloon is arranged to surround the first tip section and a second section of the balloon is attached to the second tip section.

15. The apparatus of claim 14 , wherein the first section of the balloon comprises a tapered diameter decreasing toward the distal end of the tip section.

16. A method for crossing a tissue region, the method comprising:
arranging a tip section of a catheter on the tissue region, the catheter being sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal, the tip section including a needle portion and a balloon having a first section and a second section with at least a portion of the second section being coupled to the tip section;
puncturing the tissue region using the needle portion to create an opening using a hydraulic actuator coupled to a proximal end of the catheter to drive the needle portion through the tissue region;
retracting the needle portion within the tip section;
advancing the balloon within the opening in the tissue region;
dilating the opening in the tissue region by inflating the balloon with the first section being configured to inflate prior to the second section; and
passing at least a portion of the tip section through the opening in the tissue region using the hydraulic actuator.

17. The method of claim 16 , wherein dilating the opening and passing the at least a portion of the tip section through the opening occurs concurrently with inflation of the balloon.

18. The method of claim 16 , wherein retracting the needle portion within the tip section occurs prior to advancing a first section of the balloon within the tissue region.

19. The method of claim 16 , wherein dilating the opening in the tissue region by inflating the balloon comprises asymmetrically inflating the balloon section.

20. The method of claim 19 , wherein asymmetrically inflating the balloon comprises inflating a distal portion of the balloon at a greater rate than a proximal section of the balloon.

Assignees

• Boston Scient Scimed Inc
• Mayo Found Medical Education & Res

Inventors

• Adriaens Joseph E
• Pagoria Douglas D
• Eggert Joel T
• Rohl James P
• Mcgowan Roger W
• Baldwin Katherine L
• College Todd
• Cawthra Jr James K
• Petersen Eric M
• Klos James A
• Pennington Douglas

Classifications

• A61M25/0133

  Tip steering devices · CPC title

• A61B2017/3486

  Balloon · CPC title

• A61M2025/0687

  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 title

• A61B17/3478

  Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067) · CPC title

• A61B2017/00247

  Making holes in the wall of the heart, e.g. laser Myocardial revascularization · CPC title