DELIVERY OF THERAPEUTIC AND MARKING SUBSTANCE THROUGH INTRA LUMEN EXPANSION OF A DELIVERY DEVICE

• US 20090187144A1
• Filed: 01/18/2008
• Published: 07/23/2009
• Est. Priority Date: 01/18/2008
• Status: Active Grant

• Current Assignee: Swaminathan Jayaraman
• Original Assignee: Swaminathan Jayaraman
• Inventors: Jayaraman, Swaminathan
• Granted Patent: US 8,162,880 B2
• Time in Patent Office: Days
• US Class Current: 604/103.20
• 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: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

A balloon catheter is formed with a plurality of depressions. The balloon is coated with a matrix incorporating a therapeutic substance, which additionally fills the depressions. When the balloon is expanded within a body lumen, the therapeutic substance may diffuse into the lumen wall, or all or a portion of the coating transfers to the lumen wall. A lattice frame may surround the balloon, applied prior to coating if the coating is to transfer, operative to maintain a more linear balloon profile during inflation, promoting more even transfer pressure. A contrast dye is incorporated into the transferred coating, enabling ready location and inspection of the treated lumen area. Projections may alternately be formed in the balloon surface, operative to urge the coating and therapeutic substance between cells, or past cell layers of the lumen, to the interior of the lumen wall. Prior to transfer, an extended inflation period, possibly including the use of perfusion ports to maintain blood supply, enables a larger initial quantity of therapeutic substance to diffuse into the body lumen, prior to transfer of the coating and withdrawal of the catheter, balloon, and frame.

Claims

1. A device for delivering a therapeutic substance to the interior of a body lumen wall, comprising:

a catheter including a catheter lumen;

a balloon connected to said catheter, the interior of said balloon in communication with said catheter lumen, said balloon operable to be inflated by an inflation pressure exerted by a gas or liquid passed through said catheter lumen;

a flexible lattice frame encircling at least a region including the central one third of said balloon, said frame requiring substantially more force to expand than said balloon; and

a coating applied over at least a portion of said lattice frame and the exterior of said balloon including a therapeutic substance and a substance operative to adhere to the interior of the body lumen wall;

wherein said balloon expands said lattice frame when inflated by said inflation pressure; and

wherein said balloon and encircling lattice contact said body lumen wall with a substantially more linear inflated profile than if said balloon were not encircled by said lattice; and

wherein said coating is transferred from said balloon and encircling frame to said body lumen wall upon contact of said coating with said body lumen wall after expansion of said balloon and encircling frame; and

wherein said therapeutic substance within said coating diffuses into the body lumen wall through contact with said body lumen wall by said coating.

2. The device of claim 1, wherein said frame encircles more than half of the balloon surface.

3. The device of claim 1, wherein said coating comprises at least two layers, including:

a first layer proximate said balloon, adhered to said balloon;

a second layer above said first layer;

wherein said second layer, when pressed against said body lumen wall, adheres against said body lumen wall with greater strength than the strength with which said first layer adheres to said balloon.

4. The device of claim 1, wherein said coating contains more than one therapeutic substance.

5. The device of claim 1, wherein said frame shrinks to maintain engagement with said balloon after said balloon has been deflated after inflation, whereby said frame is removed with said balloon as said catheter is removed from the body.

6. The device of claim 1, wherein said frame remains within the body lumen after said catheter and said balloon are removed from the body.

7. The device of claim 6, wherein said frame biodegrades after a period of diffusion of said therapeutic substance from said coating into the body lumen wall.

8. The device of claim 1, wherein said coating contains a contrast agent operative to be readily viewable cooperative with medical imaging apparatus.

9. The device of claim 1, further including perfusion ports within the catheter body, operative to permit fluid to flow from the body lumen, through said catheter, past an inflated balloon.

10. The device of claim 1, wherein said catheter further includes:

at least one additional balloon, at least one of which having at least one of said coating.

11. The device of claim 1, wherein said coating is resilient, and serves to cushion the impact of the balloon surface with the body lumen wall during inflation, and while the balloon remains inflated.

12. A device for delivering a therapeutic substance to the interior of a body lumen wall, comprising:

a catheter including a catheter lumen;

a balloon connected to said catheter and having an outer surface including a plurality of depressions formed therein, and an interior in communication with said catheter lumen, said balloon operable to be inflated by an inflation pressure exerted by a gas or liquid passed through said catheter lumen;

a coating applied over at least a portion of the exterior of said balloon, filling a plurality of said depressions, said coating including a therapeutic substance and a substance operative to adhere to the interior of the body lumen wall;

wherein said coating is transferred from said balloon to said body lumen wall upon contact of said coating with said body lumen wall after inflation of said balloon; and

wherein said therapeutic substance within said coating diffuses into the body lumen wall through contact with said body lumen wall by said coating.

13. The device of claim 12, wherein said coating comprises at least two layers, including:

a first layer proximate said balloon, adhered to said balloon;

a second layer above said first layer;

wherein said second layer, when pressed against said body lumen wall, adheres against said body lumen wall with greater strength than the strength with which said first layer adheres to said balloon.

14. The device of claim 12, wherein said coating contains more than one therapeutic substance.

15. The device of claim 12, wherein said coating contains a contrast agent operative to be readily viewable cooperative with medical imaging apparatus.

16. The device of claim 12, further including perfusion ports within the catheter body, operative to permit fluid to flow from the body lumen, through said catheter, past an inflated balloon.

17. The device of claim 12, wherein said balloon is inflated for at least 5 seconds.

18. The device of claim 12, wherein said balloon is inflated multiple times before being removed from the body.

19. The device of claim 12, wherein said catheter further includes:

at least one additional balloon, at least one of which having at least one of said coating.

20. A device for delivering a therapeutic substance into the interior of a body lumen wall, comprising:

a catheter including a catheter lumen;

a balloon connected to said catheter and having an outer surface including a plurality of projections formed thereon sized to penetrate into the body lumen wall, and an interior in communication with said catheter lumen, said balloon operable to be inflated by an inflation pressure exerted by a gas or liquid passed through said catheter lumen;

a coating applied over at least a portion of the exterior of said balloon, said coating including a therapeutic substance and a substance operative to adhere to the interior of the body lumen wall;

wherein said coating is transferred from said balloon to said body lumen wall upon contact of said coating with said body lumen wall after inflation of said balloon; and

wherein said therapeutic substance within said coating diffuses into the body lumen wall through contact with said body lumen wall by said coating, said diffusion into the body lumen wall accelerated by said projections, operative to urge said coating into the interior of the body lumen wall.

21. The device of claim 20, wherein said projections are operative to urge said coating into the interstices between cells.

22. The device of claim 20, wherein said projections have a height dimension which is greater than the dimension of the thickness of the intima of the body lumen at a location of intended use in the body.

23. The device of claim 20, wherein said projections have a height dimension which is greater than the combined dimensions of the thickness of the intima and the thickness of the media of the body lumen at a location of intended use in the body.

24. A device for delivering a therapeutic substance to the interior of a body lumen wall, comprising:

a catheter including a catheter lumen;

a balloon connected to said catheter and having an outer surface including a plurality of depressions formed therein, and an interior of said balloon in communication with said catheter lumen, said balloon operable to be inflated by an inflation pressure exerted by a gas or liquid passed through said catheter lumen;

a flexible lattice frame encircling at least a region including the central one third of said balloon, said frame requiring substantially more force to expand than said balloon; and

a coating applied over at least a portion of said lattice frame and the exterior of said balloon, filling a plurality of said depressions, including a therapeutic substance and a substance operative to adhere to the interior of the body lumen wall;

wherein said balloon expands said lattice frame when inflated by said inflation pressure; and

wherein said balloon and encircling lattice contact said body lumen wall with a substantially more linear inflated profile than if said balloon were not encircled by said lattice; and

wherein said coating is transferred from said balloon and encircling frame to said body lumen wall upon contact of said coating with said body lumen wall after expansion of said balloon and encircling frame; and

wherein said therapeutic substance within said coating diffuses into the body lumen wall through contact with said body lumen wall by said coating.