Stent deployment and postdilatation non-compliant balloon catheter and methods of use

• US 10,278,850 B2
• Filed: 06/05/2017
• Issued: 05/07/2019
• Est. Priority Date: 03/27/2014
• Status: Active Grant

• Current Assignee: Clever Cath Technologies Llc
• Original Assignee: Clever Cath Technologies Llc
• Inventors: Majano, Romeo
• Primary Examiner(s): Dang, Anh T
• Application Number:
  US15/613,937
• Publication Number:
  US 20170281380A1
• Time in Patent Office: 701 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• 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 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A method of inserting a stent includes inserting a unitary, monolithic catheter assembly into a cardiac artery. The catheter assembly includes a body having a proximal end and a distal end, a distal balloon mounted on the distal end, and a proximal balloon mounted on the body, proximally of the distal balloon. A balloon expandable stent is mounted on the distal balloon. The method further includes the steps of advancing the catheter assembly to a blockage in the artery until the distal balloon and the stent both extend across the blockage; inflating the distal balloon and expanding the stent; deflating the distal balloon; advancing the catheter body distally until the proximal balloon extends within the stent; expanding the proximal balloon to post-dilate the stent; deflating the proximal balloon; and withdrawing the catheter body from the artery.

Claims

1. A method of inserting a stent comprising the steps of, in order:

(a) inserting no more than a single, monolithic catheter over a single guide wire into a cardiac artery, the catheter comprising;

(i) a unitary catheter body having a proximal end and a distal end, and a first lumen, a second lumen, and a third lumen formed in the body;

(ii) a distal balloon directly attached to the distal end of the catheter body, the distal balloon being in fluid communication with the first lumen;

(iii) a proximal balloon directly attached to the catheter body, proximally of the distal balloon, the proximal balloon being in fluid communication with the second lumen; and

(iv) a balloon expandable stent having a proximal end, the stent being mounted on the distal balloon such that the proximal end of the stent is located distal of the proximal balloon;

(b) advancing the catheter over the single guide wire to a blockage in the artery until the distal balloon and the stent both extend across the blockage;

(c) inflating the distal balloon and expanding the stent;

(d) deflating the distal balloon and disengaging the distal balloon from the stent;

(e) further advancing the catheter body distally until the proximal balloon extends within the stent;

(f) expanding the proximal balloon to post-dilate the stent;

(g) deflating the proximal balloon; and

(h) withdrawing the catheter body from the artery.

2. The method according to claim 1, wherein step (a) comprises the stent being a bio-absorbable stent.

3. The method according to claim 1, wherein step (a) comprises the proximal balloon being constructed from a non-compliant material.

4. The method according to claim 3, wherein step (a) comprises the proximal balloon being constructed from polytetrafluoroethylene nylon material.

5. The method according to claim 1, wherein step (h) further comprises withdrawing the catheter over the single guide wire.

6. A method of inserting a catheter into a single blood vessel, the method comprising the steps of:

(a) providing a catheter having;

(i) a unitary catheter body having a proximal end and a distal end;

(ii) a distal balloon directly attached to the distal end of the catheter body;

(iii) a proximal balloon directly attached to the catheter body, proximally of the distal balloon;

(iv) a first lumen extending only partially through the body and in fluid communication with the distal balloon;

(v) a second lumen extending only partially through the body and in fluid communication with the proximal balloon;

(vi) a third lumen extending to the distal end of the body; and

(vii) a balloon expandable stent having a proximal end, the stent being mounted on the distal balloon such that the proximal end of the stent is located distally of the proximal balloon;

(b) inserting the guide wire into the third lumen and advancing the catheter assembly over the single guide wire to a blockage in the single blood vessel until the distal balloon and the stent both extend across the blockage;

(c) inflating the distal balloon and expanding the stent;

(d) deflating the distal balloon and disengaging the distal balloon from the stent;

(e) further advancing the catheter body distally until the proximal balloon extends within the stent;

(f) expanding the proximal balloon to post-dilate the stent;

(g) deflating the proximal balloon; and

(h) withdrawing the catheter body from the artery.

7. A method of inserting a catheter into a single blood vessel, the method comprising the steps of:

(a) providing a catheter having;

(i) a unitary catheter body having a proximal end and a distal end;

(ii) a distal balloon directly attached to the distal end of the catheter body, the distal balloon having a distal balloon length;

(iii) a proximal balloon directly attached to the catheter body, proximally of the distal balloon;

(iv) a first lumen extending only partially through the body and in fluid communication with the distal balloon;

(v) a second lumen extending only partially through the body and in fluid communication with the proximal balloon;

(vi) a third lumen extending to the distal end of the body; and

(vii) a balloon expandable stent disposed on the distal balloon, a proximal end of the stent at a proximal end of the distal balloon;

(b) inserting the guide wire into the third lumen and advancing the catheter assembly over the single guide wire to a blockage in the single blood vessel until the distal balloon and the stent both extend across the blockage;

(c) inflating the distal balloon and expanding the stent;

(d) deflating the distal balloon and disengaging the distal balloon from the stent;

(e) further advancing the catheter body distally until the proximal balloon extends within the stent;

(f) expanding the proximal balloon to post-dilate the stent;

(g) deflating the proximal balloon; and

(h) withdrawing the catheter body from the artery.