Method for treating a target site in a vascular body channel

• US 9,114,031 B2
• Filed: 03/31/2014
• Issued: 08/25/2015
• Est. Priority Date: 08/13/2009
• Status: Active Grant

• Current Assignee: Nfinium Vascular Technologies, LLC
• Original Assignee: Quadra Endovascular, Inc.
• Inventors: Fulton, Richard E. III
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US14/231,014
• Publication Number:
  US 20140214146A1
• Time in Patent Office: 512 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 606191-199, 606/200, 604/96.01, 604/101.01, 604/101.02, 604/101.03
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method of treating a target site within a vascular channel of the body uses a catheter assembly having proximal and distal occluders which are positioned in occluding states at positions proximal and distal of a target site to define an occluded region therebetween. An agent is injected into the region. An intervention is performed at the target site while the vessel is occluded and the agent is in the region. The catheter assembly is removed from the channel. Intervention may include expanding a balloon within a temporary stent structure against the channel, collapsing balloon and then removing the collapsed balloon and stent structure from the channel. A balloon stent assembly comprises a catheter assembly, a temporary stent surrounding a balloon, the temporary stent placeable in a contracted state by the catheter assembly and in an expanded state by inflation of the balloon.

Claims

1. A method of treating a target region within a vascular channel, the method comprising:

introducing an agent into the target region;

expanding a stent structure against an inner wall of the target region;

leaving the stent structure expanded against the inner wall for a period of time to maintain pressure against the inner wall and allow the introduced agent to infuse into the target region, wherein the expanded stent structure maintains sufficient pressure against the inner wall to inhibit elastic recoil thereof; and

collapsing the stent structure.

2. The method of claim 1, further comprising occluding the target region of the vascular channel between a proximal occluder and a distal occluder, the proximal and distal occluders being in expanded states to occlude the target region.

3. The method of claim 2, further comprising removing the proximal and distal occluders.

4. The method of claim 2, wherein occluding the region of the vascular channel comprises positioning the proximal occluder in a vascular channel-occluding state within the vascular channel at a first position proximal of the target region and advancing the distal occluder through a lumen of the proximal occluder to position the distal occluder in a vascular channel-occluding state within the vascular channel at a second position distal of the target region.

5. The method of claim 2, further comprising advancing an interventional catheter over a wire of the distal occluder to position the stent structure between the proximal and distal occluders, wherein the interventional catheter comprises the stent structure.

6. The method of claim 1, wherein expanding the stent structure against the inner wall of the target region comprises expanding a balloon in the target region, the stent structure being disposed over the balloon.

7. The method of claim 6, wherein leaving the stent structure expanded against the inner wall for a period of time comprises collapsing the expanded balloon.

8. The method of claim 7, further comprising removing the collapsed balloon.

9. The method of claim 6, wherein introducing the agent into the target region comprises introducing the balloon into the target region.

10. The method of claim 9, wherein the balloon comprises a drug-eluting balloon or a drug-coated balloon.

11. The method of claim 1, wherein the introduced agent comprises one or more of a diagnostic agent or a therapeutic agent.

12. The method of claim 11, wherein the therapeutic agent comprises an anti-proliferative drug.

13. The method of claim 1 wherein the stent structure is left expanded against the inner wall for longer than 3 minutes.

14. The method of claim 13, wherein the stent structure is left expanded against the inner wall for more than 90 minutes.

15. The method of claim 1, further comprising performing an intervention to the target site prior to introducing the agent into the occluded region.

16. The method of claim 1, wherein one or more of maintaining pressure against the inner wall with the expanded stent structure or allowing the introduced agent to infuse into the target prevents elastic recoil of the inner wall.

17. The method of claim 16, wherein maintaining pressure against the inner wall with the expanded stent structure and allowing the introduced agent to infuse into the target region combine to prevent elastic recoil of the inner wall.

18. A method of treating a target region of a vascular channel, the method comprising:

occluding the target region of the vascular channel between a proximal occluder and a distal occluder, the proximal and distal occluders being in expanded states to occlude the target region;

introducing an agent into the occluded target region;

expanding a balloon in the occluded target region to (i) dilate the target region, (ii) expand a stent structure disposed over the balloon against an inner wall of the target region, and (iii) force the introduced agent into the inner wall;

collapsing the balloon to leave the stent structure expanded against the inner wall to maintain pressure against the inner wall;

removing the introduced agent from the occluded target region, wherein at least a portion of the introduced agent remains forced into the inner wall;

leaving the stent structure expanded against the inner wall for a period of time to inhibit elastic recoil of the inner wall, allowing the introduced agent forced into the inner wall to infuse therein;

collapsing the proximal and distal occluders while the stent structure is left expanded to restore blood flow through the dilated target region; and

collapsing the stent structure.