THROMBUS PENETRATING DEVICES, SYSTEMS, AND METHODS

• US 20130060269A1
• Filed: 09/07/2011
• Published: 03/07/2013
• Est. Priority Date: 09/07/2011
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Roorda, Wouter E., Fortson, Aaron M.
• Granted Patent: US 8,852,220 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing

Abstract

A device for penetrating occlusive material in a body lumen is provided that may include an outer tube, an intermediate tube, and an inner tube. At least a portion of the intermediate tube may be moveably disposed within the outer tube. At least a portion of the inner tube may be moveably disposed within the intermediate tube. A first dynamic member may be operably connected to the intermediate tube and the inner tube. The first dynamic member may be configured to penetrate the occlusive material and to anchor the first dynamic member within the occlusive material. A second dynamic member may be operably connected to the outer tube and the intermediate tube. The second dynamic member may be configured to penetrate the occlusive material and to anchor the second dynamic member within the occlusive material and to support movement of the first dynamic member.

Claims

1. A device for penetrating occlusive material in a body lumen comprising:

an outer tube;

an intermediate tube, at least a portion of the intermediate tube being moveably disposed within the outer tube;

an inner tube, at least a portion of the inner tube being moveably disposed within the intermediate tube, the inner tube including a penetrating member;

a first dynamic member operably connected to the intermediate tube and the inner tube, the first dynamic member being moveable between a first position in which the first dynamic member is substantially elongated to penetrate the occlusive material with the penetrating member and a second position in which the first dynamic member is substantially radially expanded to anchor the first dynamic member within the occlusive material; and

a second dynamic member operably connected to the intermediate tube and the outer tube, the second dynamic member being moveable between a first position in which the second dynamic member is substantially elongated to penetrate the occlusive material and a second position in which the second dynamic member is substantially radially expanded to anchor the second dynamic member within the occlusive material and to support movement of the first dynamic member.

2. The device of claim 1, wherein the first dynamic member is moveable between the first position and the second position by relative movement of the intermediate tube and the inner tube relative to one another.

3. The device of claim 1, wherein the second dynamic member is moveable between the first position and the second position by relative movement of the intermediate tube and the outer tube relative to one another.

4. The device of claim 1, wherein the first dynamic member and the second dynamic member are interconnected by an elastomeric section configured to move the first dynamic member between the first position and the second position in response to movement of the second dynamic member between the first position and the second position.

5. The device of claim 1, wherein the first dynamic member comprises an accordion-like structure having a plurality of segments pivotally connected at pivots, the plurality of segments concentrically surround at least a portion of the inner tube, wherein the plurality of segments are substantially rigid and configured to have a predetermined radial strength to selectively exert a force against the occlusive material when the first dynamic member is in the second position.

6. The device of claim 5, wherein a stretchable casing is disposed over the plurality of segments, the casing being configured to conform to the shape of the first dynamic member in the first position and the second position.

7. The device of claim 5 wherein the segments are pivoted relative to one another along the pivots to form a saw-tooth configuration with the pivots outwardly extending to form an enlargement when the first dynamic member is in the second position.

8. The device of claim 5, wherein the segments are substantially parallel with the inner tube when the first dynamic member is in the first position.

9. The device of claim 1, wherein the first dynamic member is rotatably connected to the inner tube and the intermediate tube, and wherein the first dynamic member is configured to rotate relative to the inner tube and the intermediate tube.

10. The device of claim 1, wherein the first dynamic member comprises a coil spring concentrically surround at least a portion of the inner tube, the coil spring having a plurality of coil segments in a conical configuration, the coil segments being configured to move through the occlusive material when the first dynamic member moves toward the first position.

11. The device of claim 1, wherein the second dynamic member comprises an inflatable member having a predetermined radial strength in the second position to selectively exert a force against the occlusive material within the body lumen.

12. The device of claim 1, wherein the first dynamic member comprises an expandable stent-like structure.

13. The device of claim 1, wherein the penetrating member comprises a generally conical shape with a rounded tip.

14. The device of claim 1, wherein the penetrating member includes a heating element configured to selectively heat the occlusive material.

15. The device of claim 1, further comprising:

a proximal handle operatively connected to the first dynamic member;

an intermediate handle operatively connected to the first dynamic member and the second dynamic member; and

a distal handle operatively connected to the second dynamic member.

16. The device of claim 1, wherein the inner tube is configured to move radially and axially relative to the intermediate tube, and wherein the intermediate tube is configured to move radially and axially relative to the outer tube.

17. The device of claim 1, wherein the first dynamic member in the second position is further configured to support movement of the second dynamic member.

18. A device for penetrating occlusive material in a body lumen comprising:

an outer tube;

an intermediate tube, at least a portion of the intermediate tube being moveably disposed within the outer tube;

an inner tube, at least a portion of the inner tube being moveably disposed within the intermediate tube;

an elastomeric member surrounding at least a portion of the inner tube, the elastomeric member having a distal end and a proximal end;

a first dynamic member connected to the inner tube and the distal end of the elastomeric member, the first dynamic member being moveable between a first position in which the first dynamic member is substantially elongated to penetrate the occlusive material and a second position in which the first dynamic member is substantially radially expanded to anchor the first dynamic member within the occlusive material; and

a second dynamic member connected to the outer tube and the proximal end of the elastomeric member, the second dynamic member being moveable between a first position in which the second dynamic member is substantially elongated to penetrate the occlusive material and a second position in which the second dynamic member is substantially radially expanded to anchor the second dynamic member within the occlusive material and to support movement of the first dynamic member.

19. The device of claim 18, wherein the second dynamic member is further connected to the intermediate tube.

20. A system for recanalizing a vessel comprising:

a sheath having a distal end for being disposed in the vessel and a proximal end for being disposed externally of the vessel;

at least a portion of a penetrating device moveable disposed in the sheath, the penetrating device comprising;

an outer tube having a proximal end portion with an inner threaded portion;

an intermediate tube having a proximal end portion with an outer threaded portion configured to engage the inner threaded portion of the outer tube, the proximal end portion of the intermediate tube further having an inner threaded portion;

an inner tube having a proximal end portion with an outer threaded portion configured to engage the inner threaded portion of the intermediate tube, wherein at least a portion of the inner tube is moveably positioned within at least a portion of the intermediate tube and wherein at least a portion of the intermediate tube is moveably positioned within at least a portion of the outer tube;

a first dynamic member connected to a distal portion of the intermediate tube and a distal portion of the inner tube, the first dynamic member comprising an accordion-like structure having a plurality of segments pivotally connected to one another and being moveable between a first position in which the first dynamic member is substantially elongated to penetrate a thrombus and a second position in which the first dynamic member is substantially radially expanded to anchor the first dynamic member with the thrombus;

a second dynamic member connected to the distal portion of the intermediate tube and a distal portion of the outer tube, the second dynamic member comprising an accordion-like structure moveable between a first position in which the second dynamic member is substantially elongated to penetrate the thrombus and a second position in which the second dynamic member is substantially radially expanded to anchor the second dynamic member within the thrombus and to support movement of the first dynamic member; and

a penetrating member connected to the distal portion of the inner tube for penetrating the thrombus.

21. The system of claim 20, wherein rotational movement between the inner tube and the intermediate tube is configured to move the first dynamic member between the first position and the second position.

22. The system of claim 20, wherein rotational movement between the intermediate tube and the outer tube is configured to move the second dynamic member between the first position and the second position.

23. The system of claim 20, wherein the second dynamic member in the second position has a radial dimension greater than a radial dimension of the first dynamic member in the second position.

24. The system of claim 20, wherein the first dynamic member in the second position is further configured to support movement of the second dynamic member.

25. A method for penetrating occlusive material in a body lumen with a device including a first dynamic member connected to an inner tube and an intermediate tube, the first dynamic member being movable between a penetrating position and an anchoring position, a second dynamic member connected to an outer tube and the intermediate tube, the second dynamic member being moveable between a penetrating position and an anchoring position, and a penetrating member connected to the inner tube, the method comprising:

positioning the penetrating member of the device within the body lumen adjacent a proximal end of the occlusive material;

inserting at least the penetrating member and at least a portion of the first dynamic member into the proximal end of the occlusive material;

moving the first dynamic member into the anchoring position, wherein the first dynamic member is radially expanded to anchor at least a portion of the first dynamic member within the occlusive material, and wherein at least a portion of the second dynamic member is pulled into the occlusive material by the first dynamic member;

moving the second dynamic member into the anchoring position, wherein the second dynamic member is radially expanded to anchor to at least a portion of the second dynamic member within the occlusive material;

moving the first dynamic member into the penetrating position, wherein the first dynamic member axially extends to further penetrate the occlusive material with the penetrating member, wherein the second dynamic member in the anchoring position is configured to support movement of the first dynamic member toward the penetrating position; and

moving the second dynamic member between the penetrating position and the anchoring position and moving the first dynamic member between the anchoring position and the penetrating position until the penetrating member passes through a distal end of the occlusive material.

26. The method of claim 25, further comprising moving the first dynamic member between the penetrating position and the anchoring position and moving the second dynamic member between the penetrating position and the anchoring position until the second dynamic member passes through the distal end of the occlusive material.

27. The method of claim 25, further comprising removing the device from the occlusive material after the penetrating member has passed through the distal end of the occlusive material and inserting a stent through the occlusive material to maintain a flow path between the proximal end and the distal end of the occlusive material.