Method for treating a target site in a vascular body channel

• US 8,740,961 B2
• Filed: 06/10/2010
• Issued: 06/03/2014
• Est. Priority Date: 08/13/2009
• Status: Active Grant

• Current Assignee: Nfinium Vascular Technologies, LLC
• Original Assignee: Richard Eustis Fulton, III
• Inventors: Fulton, Richard Eustis III
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/813,339
• Publication Number:
  US 20110040319A1
• Time in Patent Office: 1,454 Days
• Field of Search: 606191-200, 604/96.01, 60410101-10103, 623 111- 116
• US Class Current: 623/1.11
• 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 site within a vascular channel of the body using a catheter assembly, the catheter assembly comprising (1) a proximal occluder having an inner lumen and an occlusion element at its distal end and (2) a distal occluder comprising a wire having an occlusion element at a distal end of the wire, the method comprising:

positioning the proximal occluder in a vascular channel-occluding state within the vascular channel with its occlusion element at a first position proximal of a target site thereby occluding the vascular channel at the first position, the vascular channel having an inner wall;

advancing the distal occluder through the lumen of the proximal occluder to position the occlusion element of the distal occluder in a vascular channel-occluding state within the vascular channel at a second position distal of the target site thereby occluding the vascular channel at the second position and thereby defining a region between the distal and proximal occluders;

injecting an agent into the region;

advancing an interventional catheter over the wire of the distal occluder to position an interventional element between the two occlusion elements, the interventional element comprising a stent structure configured to support and maintain pressure against the inner wall and an expandable balloon located within the stent structure;

performing an intervention at the target site with the interventional element while the occlusion elements of the distal and proximal occluders are in their vascular channel-occluding states and the agent is in the region, wherein performing the intervention comprises;

(i) expanding the balloon to expand the stent structure against the inner wall of the vascular channel,

(ii) collapsing the balloon leaving the stent structure expanded against the inner wall to maintain pressure against the inner wall,

(iii) leaving the stent structure expanded against the inner wall for a period of time to inhibit elastic recoil of the inner wall while the balloon is collapsed to allow the occluded region to be bathed by the injected agent through the stent structure, and

(iv) collapsing the stent structure; and

removing the interventional catheter, including the collapsed balloon and the collapsed stent structure of the interventional element, and the catheter assembly from the vascular channel.

2. The method according to claim 1, further comprising aspirating the region prior to injecting the agent into the region.

3. The method according to claim 1, wherein the agent injecting step comprises injecting at least one of a diagnostic agent and a therapeutic agent.

4. The method according to claim 1, wherein said intervention performing step comprises application of electric current to the inner wall of the vascular channel, whereby pores may be created in cell membranes of the inner wall.

5. The method according to claim 1, wherein said intervention performing step comprises application of electric current to the inner wall of the vascular channel through the temporary stent structure, whereby transient pores may be created in cell membranes of the inner wall.

6. The method according to claim 1, wherein the expanding step comprises expanding the balloon against an occlusion on the inner wall.

7. The method according to claim 1, wherein the stent structure is left expanded against the inner wall for longer than 3 minutes.

8. The method according to claim 1, wherein the stent structure is left expanded against the inner wall for 3 to 90 minutes.

9. The method according to claim 1, wherein the stent structure is left expanded against the inner wall for more than 90 minutes.

10. The method according to claim 1, wherein the intervention performing step carried out before the agent injecting step.

11. The method according to claim 1, wherein the intervention performing step comprises performing a first intervention procedure, followed by the agent injecting step, followed by a second intervention procedure.

12. The method according to claim 11, wherein the first and second intervention procedures are substantially the same.

13. The method according to claim 1, further comprising selectively repositioning at least one of the distal and proximal occluders during the intervention performing step.

14. A method of treating a target site within a vascular channel of the body using a catheter assembly, the catheter assembly comprising (1) a proximal occluder having an inner lumen and an occlusion element at its distal end and (2) a distal occluder comprising a wire having an occlusion element at the distal end of the wire, the method comprising:

positioning the proximal occluder in a vascular channel-occluding state within the vascular channel with its occlusion element at a first position proximal of a target site thereby occluding the vascular channel at the first position, the vascular channel having an inner wall;

advancing the distal occluder through the lumen of the proximal occluder to position the occlusion element of the distal occluder in a vascular channel-occluding state within the vascular channel at a second position distal of the target site thereby occluding the vascular channel at the second position and thereby defining a region between the distal and proximal occluders;

injecting an anti-proliferative drug into the region;

advancing an interventional catheter over the wire of the distal occluder to position an interventional element comprising a stent structure configured to support and maintain pressure against the inner wall and an expandable balloon within the stent structure between the two occlusion elements;

performing of a therapy using the interventional element while the distal and proximal occluders are in their vascular channel-occluding states and the anti-proliferative drug is in the region, wherein the performed therapy comprises;

(i) expanding the balloon to expand the stent structure against the inner wall of the vascular channel;

(ii) collapsing the balloon leaving the stent structure expanded against the inner wall to maintain pressure against the inner wall,

(iii) leaving the stent structure expanded against the inner wall for a period of time to inhibit elastic recoil of the inner wall while the balloon is collapsed to allow the occluded region to be bathed by the injected agent through the stent structure, and

(iv) collapsing the stent structure;

removing the intervention catheter, interventional element, anti-proliferative drug, and other material from the region; and

removing the catheter assembly from the vascular channel.