Apparatus and method for advancing catheters or other medical devices through a lumen

Patent metadata

Field	Value
Publication number	US-12048820-B2
Application number	US-202117221448-A
Country	US
Kind code	B2
Filing date	Apr 2, 2021
Priority date	Aug 14, 2019
Publication date	Jul 30, 2024
Grant date	Jul 30, 2024

Abstract

Devices, systems, and methods are disclosed that help deliver catheters or other medical devices to locations within a patient's body. The device includes a transporter catheter having a proximal end and a distal end, at least a first balloon located at the distal end, substantially at a tip of the transporter catheter, and at least a second balloon located between the distal end and the proximal end of the transporter catheter. The first balloon is an orienting balloon and the second balloon is an anchor balloon. The transporter catheter may include a single lumen or more than one lumen. The transporter catheter may include a shaft including an inner layer and an outer layer, the inner layer may be made of a material more flexible than the material of the outer layer. The outer layer may also include a braided-wire assembly, said braided-wire assembly being formed by braiding a plurality of flat wires or circular wires. The braided-wire assembly may wrap around the inner layer. The transporter catheter may include a shaft that may include a plurality of segments of varying degrees of hardness. The degree of hardness of the segment of the shaft of the transporter catheter located between the first balloon and the second balloon may be less than the degree of hardness of the segment of the shaft between the second balloon and the proximal end of the catheter.

First claim

The invention claimed is:

1. A method for intravascular treatment using a transporter catheter in an intravascular treatment system, comprising: a) assembling the intravascular treatment system comprising the transporter catheter and an outer catheter; the transporter catheter comprising a shaft, at least one anchor balloon, and an orienting balloon; the outer catheter comprising a lumen, a proximal region and a distal region; b) inflating the at least one anchor balloon, and anchoring the transporter catheter inside the lumen of the outer catheter, the anchoring of the transporter catheter being performed at least in the distal region of the outer catheter; c) inflating the orienting balloon situated proximal to a distal end of the transporter catheter; d) adjusting a pressure of a fluid inside the orienting balloon and/or the at least one anchor balloon to adjust a stiffness of the intravascular treatment system at least in the distal region of the outer catheter; e) pushing and/or torqueing the transporter catheter in a vessel to advance the intravascular treatment system while the orienting balloon is inflated and f) advancing the intravascular treatment system such that the outer catheter slidably engages a vessel wall of the vessel as the intravascular system is advanced to a desired location proximal to a treatment site in the vessel.

2. The method of claim 1 , wherein adjusting the stiffness of the intravascular treatment system comprises variation and control of stiffness of the intravascular treatment system using the orienting balloon and/or the at least one anchor balloon, wherein the pressure of the fluid inside the anchor balloon and/or the orienting balloon is increased to increase the stiffness of the intravascular treatment system and the pressure of the fluid inside the at least one anchor balloon and/or the orienting balloon is decreased to decrease the stiffness of the intravascular treatment system.

3. The method of claim 1 , wherein the intravascular treatment system is steerable using a steering mechanism, said steering mechanism connected to the transporter catheter and/or the outer catheter.

4. The method of claim 1 , wherein the transporter catheter comprises at least one radiopaque marker on at least a distal region of the transporter catheter.

5. The method of claim 1 , wherein the shaft of the transporter catheter comprises at least one internal channel for a guidewire.

6. The method of claim 1 , wherein the transporter catheter comprises a proximal region and a distal region, and the at least one anchor balloon is located on the distal region of the transporter catheter, and upon inflation, the at least one anchor balloon anchors to the outer catheter by pressing against an inner surface of the lumen of the outer catheter in the distal region of the outer catheter.

7. The method of claim 1 , further comprising advancing a medical device, said medical device positioned in the intravascular treatment system at a location selected from a group of locations including (a) the orienting balloon, and (b) a third balloon formed on the shaft between the orienting balloon and the at least one anchor balloon.

8. The method of claim 7 , wherein the medical device is a prosthetic heart valve and the method further comprises advancing the prosthetic heart valve proximal to a native diseased valve, disengaging the transporter catheter from the outer catheter by deflating the anchor balloon, and advancing the transporter catheter distally relative to the outer catheter to position the prosthetic valve proximal to the treatment site.

9. The method of claim 8 , wherein the prosthetic heart valve is crimped and/or expandable.

10. A method for intravascular treatment using a transporter catheter in an intravascular treatment system, comprising: a) assembling the intravascular treatment system comprising the transporter catheter and an outer catheter; the transporter catheter comprising a shaft, at least one anchor balloon, and an orienting balloon; the outer catheter comprising a lumen, a proximal region and a distal region; b) extending the guidewire along the at least one internal channel of the transporter catheter with a proximal end of the guidewire extending beyond a proximal end of the of the transporter catheter and a distal end of the guidewire extending beyond a distal end of the transporter catheter; c) advancing the distal end of the guidewire towards a desired location proximal to a treatment site in a vessel of interest; d) inflating the at least one anchor balloon and anchoring the transporter catheter inside the lumen of the outer catheter; e) inflating the orienting balloon situated proximal to the distal end of the transporter catheter; f) pushing and torqueing the transporter catheter to advance the intravascular treatment system through a patient's vasculature while the orienting balloon is inflated; g) adjusting a pressure of a fluid inside the orienting balloon and/or the anchor balloon to adjust a stiffness of the intravascular treatment system at least in the distal region of the outer catheter; and h) advancing the intravascular treatment system to the desired location in the vessel of interest proximal to the treatment site such that the outer catheter slidably engages a vessel wall of the vessel of interest during the advancing.

11. The method of claim 10 , wherein adjusting the stiffness of the intravascular treatment system comprises variation and control of stiffness of the intravascular treatment system using the orienting balloon and/or the at least one anchor balloon, wherein the pressure of the fluid inside the anchor balloon and/or the orienting balloon is increased to increase the stiffness of the intravascular treatment system and the pressure of the fluid inside the at least one anchor balloon and/or the orienting balloon is decreased to decrease the stiffness of the intravascular treatment system.

12. The method of claim 10 , wherein the intravascular treatment system is steerable using a steering mechanism, said steering mechanism connected to the transporter catheter and/or the outer catheter.

13. The method of claim 10 , wherein the transporter catheter has at least one radiopaque marker on at least a distal region of the transporter catheter.

14. The method of claim 10 , wherein the anchoring the transporter catheter is performed at least in the distal region of the outer catheter.

15. The method of claim 14 , wherein the transporter catheter comprises a proximal region and a distal region, and the at least one anchor balloon is located on the distal region of the transporter catheter, and upon inflation the at least one anchor balloon anchors to the outer catheter by pressing against an inner surface of the lumen of the outer catheter in the distal region of the outer catheter.

16. The method of claim 10 , further comprising advancing a medical device, said medical device positioned in the intravascular treatment system at a location selected from a group of locations including (a) the orienting balloon, and (b) a third balloon formed on the shaft between the orienting balloon and the at least one anchor balloon.

17. The method of claim 16 , wherein the medical device is a prosthetic heart valve and the method further comprises advancing the prosthetic heart valve proximal to a native diseased valve, disengaging the transporter catheter from the outer catheter by deflating the anchor balloon, and advancing the transporter catheter distally relative to the outer catheter to position the prosthetic valve proximal to the treatment site.

Assignees

• Sardesai Rajendra Gurudas
• Pancholy Samir Bipin
• Patel Tejas Madhusudan
• Vasoinnovations Inc

Inventors

• Sardesai Rajendra Gurudas
• Pancholy Samir Bipin
• Patel Tejas Madhusudan

Classifications

• A61F2/958

  Inflatable balloons for placing stents or stent-grafts · CPC title

• A61M2025/1088

  having special surface characteristics depending on material properties or added substances, e.g. for reducing friction · CPC title

• A61M2025/015

  Details of the distal fixation of the movable mechanical means · CPC title

• A61M25/0102

  Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod · CPC title

• A61M25/0116

  self-propelled, e.g. autonomous robots (A61M25/0122 takes precedence) · CPC title