Devices and methods for disruption and removal of luminal occlusions

• US 20050033334A1
• Filed: 05/12/2004
• Published: 02/10/2005
• Est. Priority Date: 05/12/2003
• Status: Active Grant

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Inventors: Batich, Christopher D., Santra, Swadeshmukul, Mericle, Robert A., Stanley, Jessie T., Eskioglu, Eric
• Granted Patent: US 7,618,434 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop

Abstract

The subject invention pertains to an elastic sheath, device, and methods for disrupting and/or removing occlusive material from lumens, particularly biological lumens, such as the vasculature, ureter, urethra, fallopian tubes, bile duct, intestines, and the like. The subject invention provides for effective disruption and removal of occlusive material, such as a thrombus, from the body lumen with minimal risk of injury to the lumen wall. Advantageously, the invention can be used to achieve a high degree of removal while minimizing the amount of occlusive material that is released into the body lumen. The subject invention further pertains to methods for disrupting and removing occlusive material from a biological lumen. In another aspect, the present invention concerns a device useful as an in vitro model of luminal occlusion and methods for using the device to test the efficacy of devices and methods for treating luminal occlusions.

Claims

1. A device for occlusion removal and/or disruption comprising:

a rod;

an elastic sheath that ensheaths a segment of said rod, wherein said sheath has a plurality of slits; and

means for expanding said elastic sheath, and wherein said elastic sheath is displaced from said segment of said rod when said expansion means is activated, and wherein said rod and said elastic sheath cooperate to form a compartment when said expansion means is activated.

2. The device of claim 1, wherein said expansion means comprises an expandable balloon, wherein at least a portion of said expandable balloon is covered by said elastic sheath.

3. The device of claim 1, wherein said plurality of slits are longitudinally arranged around at least a portion of the circumference of said elastic sheath, and wherein each slit is separated from adjacent slits by a longitudinal band of elastic material.

4. The device of claim 3, wherein said longitudinal bands are cross-linked with a plurality of lateral bands that bridge said longitudinal slits, thereby forming a mesh.

5. The device of claim 2, wherein said expandable balloon comprises at least one radially constrained portion and at least one radially unconstrained portion.

6. The device of claim 5, wherein when pressure is applied to said expandable balloon, said at least one radially unconstrained portion expands to form at least one sphere or spheroid shape.

7. The device of claim 6, wherein said at least one radially constrained portion is constrained with a fiber that is wrapped around said at least one radially constrained portion.

8. The device of claim 6, wherein the compartment is substantially conical in shape.

9. The device of claim 1, wherein the elastic sheath comprises a flexible polymer tube.

10. The device of claim 1, wherein the elastic sheath comprises a thermoplastic elastomer.

11. The device of claim 1, wherein the elastic sheath comprises a flexible polymer selected from the group consisting of silicone, polyurethane, silicone-polyurethane copolymer, and styrene-ethylene-butylene-styrene (copolymer).

12. The device of claim 1, wherein said device is at least partially composed of an imageable material.

13. A method for disruption and/or removal of occlusive material from a conduit, said method comprising:

(a) inserting the device of claim 1 into the conduit;

(b) positioning the device at a target site within or adjacent to the occlusive material;

(c) activating the expansion means, thereby displacing the elastic sheath from the rod, and wherein the rod and the elastic sheath cooperate to form a compartment when the expansion means is activated; and

(d) capturing the occlusive material within the compartment by allowing the occlusive material to pass through the slits of the elastic sheath.

14. The method of claim 13, wherein said method further comprises:

(e) deactivating the expansion means after capturing the occlusive material within the compartment, thereby collapsing the compartment; and

(f) withdrawing the device from the conduit.

15. The method of claim 13, wherein the expansion means comprises an expandable balloon.

16. The method of claim 15, wherein said method further comprises:

(e) at least partially deflating the balloon after capturing the occlusive material within the compartment, thereby collapsing the compartment; and

(f) withdrawing the device from the conduit.

17. The method of claim 13, wherein the conduit is a biological conduit.

18. The method of claim 13, wherein the conduit is a biological conduit within a human.

19. The method of claim 13, wherein the conduit is a biological conduit within a non-human animal.

20. The method of claim 13, wherein the conduit is a biological conduit selected from the group consisting of a blood vessel, ureter, urethra, fallopian tube, bile duct, and intestine.

21. The method of claim 13, wherein the conduit is an artificial conduit.

22. The method of claim 13, wherein the conduit is an artificial conduit selected from the group consisting of a catheter, stent, graft, and fistula.

23. The method of claim 13, wherein the conduit is an intracranial artery within a human patient.

24. The method of claim 13, wherein the occlusive material is deposited on the inner wall of the conduit, and wherein said method further comprises bringing the device into searing contact with the occlusive material after activating the expansion means.

25. The method of claim 13, wherein at least one portion of the device is impregnated or coated with a biologically active agent.

26. The method of claim 13, wherein the occlusive material is selected from the group consisting of thrombus, calcification, cholesterol, and plaque.

27. The method of claim 13, wherein the occlusive material is an embolic agent selected from the group consisting of adhesive, gel, silicone rubber, organic elastomer, polymerizable protein solution, silk suture, polyvinyl alcohol particles, polyvinyl alcohol foam, polyurethane foam, acrylic polymer, polyethylene foam, silicone foam, fluorinated polyolefin foam, and ethylene-vinyl-alcohol copolymer.

28. A sheath comprising an elastic tube having a plurality of slits.

29. The sheath of claim 28, wherein the elastic tube comprises a flexible polymer selected from the group consisting of silicone, polyurethane, silicone-polyurethane copolymer, and styrene-ethylene-butylene-styrene (copolymer).

30. The sheath of claim 28, wherein each slit of said plurality of slits is within the range of about 5 μ

m and about 20 μ

m in length.

31. The sheath of claim 28, wherein adjacent slits of said plurality of slits are separated from one another by about 200 μ

m to about 1000 μ

m.

32. The sheath of claim 28, wherein said sheath has a length in the range of about 5 millimeters to about 5 centimeters.

33. The sheath of claim 28, wherein said sheath has a diameter within the range of about 1 millimeter to about 1 centimeter.

34. The sheath of claim 28, wherein the sheath has a thickness within the range of about 0.05 millimeters to about 2 millimeters.

35. A device for modeling a luminal occlusion in vitro, said apparatus comprising:

(a) a flexible hollow tube having at least a first end and a second end; and

(b) an occlusion site within said tube, wherein said occlusion site comprises a receptacle for depositing occluding material.

36. The device of claim 35, wherein said tube comprises a polymer.

37. The device of claim 35, wherein said tube has a plurality of bends, and wherein each of said bends is separated by at least one of said occlusion site.

38. The device of claim 35, wherein said receptacle has two or more ports connecting said receptacle with said tube.

39. The device of claim 35, wherein said receptacle has an access port that does not connect said receptacle with said tube, and wherein occluding material can be deposited within said receptacle through said access port.

40. A method for testing the efficacy of devices and treatments for treating luminal occlusions, said method comprising:

(a) providing the device of claim 35, wherein the receptacle contains occluding material;

(b) inserting a test device into the tube, or administering a treatment into the tube; and

determining the efficacy of the device or treatment in removing, degrading, or otherwise reducing the pathological potential of the occluding material.