METHOD AND DEVICE FOR VASCULAR THERAPY

• US 20090143851A1
• Filed: 11/26/2008
• Published: 06/04/2009
• Est. Priority Date: 11/30/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Paul, Ram H. JR.
• Granted Patent: US 8,192,479 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Medical devices, as well as methods of treatment and manufacturing such devices, are provided for applying vascular therapy locally within the body vessel. The medical devices include an expandable tubular frame and a sleeve. The medical devices can be used for local delivery of a therapeutic agent within a body vessel or a tamponade for a lacerated body vessel, while simultaneously allowing perfusion of fluid or blood flow distal of the implanted medical device. The tubular frame of the medical device can have a middle region with a plurality of members. The members can expand radially outward away from a longitudinal axis of the tubular frame, which can urge the sleeve to contact the wall of the body vessel. In the expanded configuration, a portion of the device allows fluid flow to continue while the sleeve is against the body vessel wall.

Claims

1. A medical device for applying vascular therapy locally within a body vessel at a point of treatment, the medical device comprising:

a tubular frame defining a lumen about a longitudinal axis, the tubular frame having a distal end, a proximal end, and a middle region, the middle region of the tubular frame including a plurality of members defining a series of slots therebetween, the members being circumferentially spaced around the tubular frame, where the middle region of the tubular frame is moveable from a compressed configuration to an expanded configuration, where in the compressed configuration the members lie in immediate contiguous proximity to each other, and in the expanded configuration the members are displaced radially outward from the longitudinal axis to form interstices between the members in the expanded configuration; and

a sleeve encompassing a portion of the middle region of the tubular frame, where the sleeve is configured to be maintained in contact with at least a portion of the members,

where in the expanded configuration the members urge the sleeve to contact said body vessel, while the interstices permit fluid flow to areas distal to the point of treatment.

2. The medical device of claim 1, where, in the expanded configuration and the compressed configuration, the distal end and the proximal end of the tubular frame have a similar diameter.

3. The medical device of claim 2, where the middle region of the tubular frame has a first diameter in the compressed configuration and a second diameter in the expanded configuration that is greater than the first diameter, where the first diameter of the middle region is substantially identical to the diameter of the proximal and distal ends of the tubular frame.

4. The medical device of claim 3, where the slots are oriented substantially parallel to one another, and in the expanded configuration each of the members has two bends and a contacting portion therebetween, where the contacting portion is configured to substantially align with said body vessel wall.

5. The medical device of claim 1, where the tubular frame is formed from a shape memory alloy, and the middle region of the tubular frame is biased toward the expanded configuration.

6. The medical device of claim 1, further comprising a means for translating the distal end of the tubular frame along the longitudinal axis relative to the proximal end of the tubular frame to urge the members to move between the compressed configuration and the expanded configuration.

7. The medical device of claim 1, where the sleeve is elastic and is configured to exert a radially compressing restoring force on the middle region of the tubular frame in the expanded configuration.

8. The medical device of claim 1 further comprising a therapeutic agent disposed on the sleeve.

9. The medical device of claim 1, where the sleeve comprises a foamed extracellular matrix.

10. The medical device of claim 1, where the tubular frame is formed by a process comprising cutting a series of circumferentially spaced slots in a middle region of a cannula, wherein the cannula comprises a shape memory alloy.

11. A system for applying vascular therapy locally within a body vessel at a point of treatment, the system comprising:

a medical device comprising a tubular frame defining a lumen about a longitudinal axis, the tubular frame having a distal end, a proximal end, and a middle region, the middle region of the tubular frame including a plurality of members defining a series of slots therebetween, the members being circumferentially spaced around the tubular frame, where the middle region of the tubular frame is moveable from a compressed configuration to an expanded configuration, where in the compressed configuration the members lie in immediate contiguous proximity to each other, and in the expanded configuration the members are displaced radially outward from the longitudinal axis to close proximity to the body vessel to form interstices between the members, and a sleeve encompassing a portion of the middle region of the tubular frame, where the sleeve is configured to be maintained in contact with at least a portion of the members, where in the expanded configuration the members urge the sleeve to contact said body vessel, while the interstices permit fluid flow to areas distal to the point of treatment; and

a catheter shaft attached to the proximal end of the tubular frame of the medical device.

12. The system of claim 11 further comprising a sheath disposed radially outward from the catheter shaft and slidably engaged thereto, the sheath being movable and sized to compress the medical device.

13. The system of claim 11 further comprising a dilator attached to the distal end of the tubular frame of the medical device.

14. The system of claim 11 further comprising a therapeutic agent disposed on the sleeve.

15. The system of claim 11, where the sleeve comprises a foamed extracellular matrix.

16. A method of applying vascular therapy to a wall of a body vessel, the method comprising:

radially compressing a middle region of a medical device to deliver the medical device to a point of treatment within said body vessel, the medical device comprising a tubular frame defining a lumen about a longitudinal axis, the tubular frame having a distal end, a proximal end, and the middle region, the middle region of the tubular frame including a plurality of members with slots therebetween, where the middle region of the tubular frame is moveable from a compressed configuration to an expanded configuration, where in the compressed configuration the members lie in immediate contiguous proximity to each other, and in the expanded configuration the members are displaced radially outward from the longitudinal axis to close proximity to said body vessel wall to form interstices between adjacent members, and a sleeve encompassing a portion of the middle region of the tubular frame,

radially expanding the members of the middle region of the tubular frame from the compressed configuration to the expanded configuration to urge the sleeve to contact the wall of said body vessel; and

maintaining the sleeve in contact with the wall of said body vessel to apply vascular therapy at the point of treatment within the body vessel, while the interstices permit fluid flow to areas distal to the point of treatment.

17. The method of claim 16, where in the expanded configuration each of the members has two bends and a contacting portion therebetween, where the contacting portion is configured to substantially align with said body vessel wall.

18. The method of claim 16, where the tubular frame is self-expanding and formed from a shape memory alloy, and where the middle region of the tubular frame is compressed by disposing a sheath about said middle region to urge the members to the compressed configuration, and the middle region is expanded by removing the sheath from said middle region.

19. The method of claim 16, where the point of treatment comprises a lacerated hole extending through the wall of said body vessel, and the sleeve comprises a foamed extracellular matrix, where the sleeve is sized suitably to cover the lacerated hole to promote hemostasis when the sleeve is in contact with the wall of said body vessel.

20. The method of claim 16, where the medical device further comprises a therapeutic agent disposed on the sleeve, where the therapeutic agent is configured to be delivered when the sleeve is in contact with the wall of said body vessel.