Dilating and support apparatus with disease inhibitors and methods for use

• US 6,450,989 B2
• Filed: 04/23/1999
• Issued: 09/17/2002
• Est. Priority Date: 04/27/1998
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Inventors: Fulton, Richard E., Dubrul, William Richard
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/298,279
• Publication Number:
  US 20010016726A1
• Time in Patent Office: 1,243 Days
• Field of Search: 604/96.01, 604/101.01, 604/101.05, 604/104, 604/530-532, 604/509, 604/103.01, 604/103.02, 604/103.05, 604/103.06, 604/103.07, 604/103.08, 604/107, 604/174, 606/108, 606/191-198, 623/1, 623/12
• US Class Current: 604/104
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A dilating and support apparatus with disease inhibitors and methods for use is disclosed that is particularly useful for repairing and/or serving as a conduit for body passageways that require reinforcement, dilatation, disease prevention or the like. Such apparatuses are utilized to deliver a therapy, that therapy being from a family of devices, drugs, or any of a variety of other elements to a specific location within the body. The instant disclosure provides a system of combining a novel radial deployment and/or drug delivery therapy with existing balloon dilatation therapy into one device. This combination will yield a significant decrease in cost to the healthcare system as well as providing a therapy to the patient with increased safety and efficacy. Further, the instant invention provides a novel and improved platform for synthetic/tissue interface between the device and the body.

Claims

1. A removable therapy delivery device for placement into, use in and removal from a passageway of the body comprising

a catheter shaft;

a radially-expandable and contractible drive element along the catheter shaft;

a radially-expandable and contractible, tubular braid surrounding the drive element; and

the tubular braid comprising absorbent fibers and a contact-dispensable agent absorbed into said absorbent fibers, whereby;

when the drive element expands the tubular braid against body tissue, the tubular braid makes intimate contact with the body tissue to permit the agent to be dispensed into the body tissue; and

when the agent has been dispensed, the drive element and tubular braid may be placed in radially-contracted state and removed from the body.

2. The device of claim 1 wherein the catheter shaft is hollow and has a distal end, the drive element is at the distal end, and the drive element comprises a balloon.

3. The device of claim 1 wherein the tubular mesh comprises hollow tubular fibers and at least a portion of said agent is contained within said hollow fibers.

4. The device of claim 1 wherein said agent is dispensable by at least one of (a) radial pressure exerted by the tubular braid, and (b) iontophoresis.

5. The device of claim 1 wherein the agent comprises at least one of a drug, a genetic material and a radiation source.

6. A removable therapy delivery device for placement into, use in and removal from a passageway of the body comprising

a catheter shaft;

a radially-expandable aid contractible drive element along the catheter shaft;

a radially-expandable and contractible, tubular mesh surrounding the drive element; and

the tubular mesh comprising a bioabsorbable material and a contact-dispensable agent, whereby;

when the drive element expands the tubular mesh against body tissue, the tubular mesh makes intimate contact with the body tissue to permit the agent to be dispensed into the body tissue; and

when the agent has been dispensed, the drive element and tubular mesh the may be placed in radially-contracted states and removed from the body.

7. A device for use in a passageway of the body comprising:

a catheter shaft;

a first radially-expandable element, comprising an inflatable balloon, at a first position along the catheter shaft; and

a second radially-expandable element, comprising;

an axially-compressible, radially-expandable, tubular braid scaffolding, at a second position along the catheter shaft; and

a radially-expandable, tubular mesh surrounding the scaffolding, the tubular mesh comprising a contact-dispensable agent,whereby a region in the passageway may be enlarged by positioning said balloon at said region and inflating said balloon to create a dilated region, and wherein after deflating said balloon said scaffolding may be positioned at the dilated region and radially expanded by axially compressing said scaffolding.

8. The device of claim 7 wherein at least one of the tubular mesh and the scaffolding is releasable from the catheter shaft when the scaffolding is axially compressed.

9. A device for use in a passageway of the body comprising:

a catheter shaft comprising proximal and distal ends, the proximal and distal ends locatable outside of the body and within a passageway of the body, respectively;

an inflatable balloon at a first position along the distal end of the catheter shaft;

an axially-compressible, radially-expandable, tubular braid scaffolding at a second position along the distal end of the catheter shaft;

a radially-expansible, tubular mesh surrounding the scaffolding, the tubular mesh comprising a contact-dispensable agent;

means for selectively axially compressing the tubular braid scaffolding and the tubular mesh from the proximal end;

whereby a region in the passageway may be enlarged by positioning said balloon at said region and inflating said balloon to create a dilated region, and wherein after deflating said balloon said scaffolding may be positioned at the dilated region and radially expanded by axially compressing said scaffolding, and wherein at least one of the tubular mesh and the scaffolding is releasable from the catheter shaft when the scaffolding is axially compressed.

10. A device used at a body exit site of an indwelling catheter comprising:

a catheter having a proximal end, which remains outside of the body, and a distal end, which is positional through an exit site and is locatable within the body;

an axially compressible, radially-expandable, tubular braid scaffolding positioned along the catheter towards the proximal end, the braid scaffolding being made of a bioabsorbable material; and

a scaffolding actuator operably coupled to the scaffolding to permit the scaffolding to be placed into an axially-compressed, radially expanded condition, whereby the scaffolding can be radially expanded at the exit site to secure the catheter in place.

11. The device of claim 10 wherein the scaffolding actuator comprises means for selectively axially-compressing the tubular braid from the proximal end.

12. A device for use in a passageway of the body comprising:

a catheter shaft;

a first radially-expandable element, comprising an inflatable balloon, at a first position along the catheter shaft;

a second radially-expandable element, comprising an axially-compressible, radially-expandable, tubular braid scaffolding, at a second position along the catheter shaft; and

a radially-expansible stent surrounding the scaffolding, said stent placeable in a stable, radially-expanded state when the scaffolding is radially expanded;

whereby a region in the passageway may be enlarged by positioning said balloon at said region and inflating said balloon to create a dilated region, and wherein after deflating said balloon said scaffolding may be positioned at the dilated region and radially expanded by axially compressing said scaffolding.

13. A device for use in a passageway of the body comprising:

a catheter shaft comprising proximal and distal ends, the proximal and distal ends locatable outside of the body and within a passageway of the body, respectively;

an inflatable balloon at a first position along the distal end of the catheter shaft;

an axially-compressible, radially-expandable, tubular braid scaffolding at a second position along the distal end of the catheter shaft;

a radially-expansible stent surrounding the scaffolding, said stent placeable in a stable, radially-expanded state when the scaffolding is radially expanded; and

means for selectively axially compressing the tubular braid scaffolding and the radially-expansible stent from the proximal end;

whereby a region in the passageway may be enlarged by positioning said balloon at said region and inflating said balloon to create a dilated region, and wherein after deflating said balloon said scaffolding may be positioned at the dilated region and radially expanded by axially compressing said scaffolding.

14. A removable therapy delivery device for placement into, use in and removal from a passageway of the body comprising

a catheter shaft;

a radially-expandable and contractible drive element along the catheter shaft;

radially-contracted state and removed from the body.