INTRACRANIAL BLOOD VESSEL DILATION DEVICE

• US 20100160951A1
• Filed: 12/19/2008
• Published: 06/24/2010
• Est. Priority Date: 12/19/2008
• Status: Abandoned Application

• Current Assignee: Michael T. Madison
• Original Assignee: Michael T. Madison
• Inventors: Madison, Michael T.
• Application Number:
  US12/340,109
• Publication Number:
  US 20100160951A1
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method of treating cerebral vasospasm includes delivering at least a first blood vessel including an expandable segment to a position within a blocked or constricted portion of a vessel and transitioning the expandable segment from a collapsed configuration to an expanded configuration to dilate the vessel and to restore adequate blood flow through the vessel. The expandable segment has a pre-set outer diameter substantially equal to or less than an inner diameter of the vessel. Additionally, the expandable segment is configured to expand with a minimal amount of radial force necessary to contact and expand the inner walls of the vessel. After dilation of the vessel, the device is removed from the patient'"'"'s body. If necessary, additional blood vessel dilation devices each including an expandable segment having a pre-set outer diameter greater than the previous device'"'"'s expandable segment can be used in order of increasing pre-set outer diameter of the expanded segment to further dilate the blocked or constricted portion of the vessel and restore blood flow through the vessel. Once adequate blood flow through the vessel has been restored, the blood vessel dilation device is withdrawn.

Claims

1. A method for re-establishing a blood flow channel in a blocked or constricted portion of an affected vessel within a patient'"'"'s body, the method comprising:

selecting at least a first blood vessel dilation device including an elongated microwire having a expandable segment configured to transition from a collapsed configuration to an expanded configuration, the expandable segment comprising at least two struts having a configuration allowing blood flow through the vessel and a pre-set outer diameter substantially equal to or less than an inner diameter of the vessel;

advancing a delivery catheter including at least one lumen to a position within the blocked or constricted portion of the vessel;

delivering the first blood vessel dilation device through the delivery catheter lumen to the blocked or constricted portion of the vessel, wherein the delivery catheter lumen is configured to retain the expandable segment in the collapsed configuration during delivery;

transitioning the expandable segment from the collapsed configuration to the expanded configuration to dilate the blocked or constricted portion of the affected vessel;

evaluating blood flow through the vessel;

collapsing the expandable segment; and

removing the first blood vessel dilating device from the patient'"'"'s body.

2. The method according to claim 1, further comprising dilating the blocked or constricted portion of the vessel by an amount sufficient to re-establish a blood flow channel in the vessel.

3. The method according to claim 1, further comprising dilating the blocked or constricted portion of the blood vessel by at least 10%.

4. The method according to claim 1, wherein the step of transitioning the expandable segment from the collapsed configuration to the expanded configuration comprises moving the catheter in a proximal direction relative to the blood vessel dilation device which is held in a fixed position relative to the catheter.

5. The method according to claim 1, wherein the step of transitioning the expandable segment from the collapsed configuration to the expanded configuration comprises moving the blood vessel dilation device in a distal direction relative to the catheter which is held in a fixed position.

6. The method according to claim 1, wherein the step of collapsing the expandable segment comprises retracting the expandable segment into the delivery catheter, wherein the catheter is held in a fixed position relative to the blood vessel dilation device.

7. The method according to claim 1, wherein the step of collapsing the expandable segment comprises holding the blood vessel dilation device including the expandable segment in a fixed position and moving the catheter in a distal direction relative to the blood vessel dilation device such that the expandable segment transitions from the expanded configuration to the collapsed configuration and is retained in the collapsed configuration within the catheter.

8. The method according to claim 1, further comprising:

selecting at least a second blood vessel dilation device including elongated microwire having an expandable segment comprising a pre-set outer diameter greater than the pre-set outer diameter of the expandable segment of the first blood vessel dilating device and substantially equal to or less than the inner diameter of the vessel;

delivering the second blood vessel dilation device through the delivery catheter lumen to the blocked or constricted portion of the vessel;

transitioning the expandable segment from the collapsed configuration to the expanded configuration to further dilate the blocked or constricted portion of the vessel;

collapsing the expandable segment from the expanded configuration to the collapsed configuration;

evaluating blood flow through the vessel; and

removing the second blood vessel dilating device from the patient'"'"'s body.

9. The method according to claim 1, wherein the expandable segment further comprises a tether coupled to a distal end of the expandable segment, and wherein the step of transitioning the expandable segment from the collapsed configuration to the expanded configuration comprises manipulating the tether in a proximal direction.

10. The method according to claim 9, wherein manipulating the tether coupled to a distal end of the expandable portion comprises moving the tether by a specified distance in the proximal direction to controllably expand the expandable portion by a proportional amount.

11. The method according to claim 9, wherein the step of collapsing the expandable segment comprises releasing the tether to transition the expandable segment from the expanded configuration to the collapsed configuration for removal from the patient'"'"'s body.

12. The method according to claim 9, further comprising expanding the expandable segment to a first pre-set outer diameter by moving the tether a first predetermined distance in a proximal direction.

13. The method according to claim 9, further comprising expanding the expandable segment to a second pre-set outer diameter by moving the tether a second predetermined distance in a proximal direction.

14. A method of dilating a blocked or constricted portion of an affected vessel within a patient'"'"'s body, the method comprising:

delivering a blood vessel dilation device to the blocked or constricted portion of the blood vessel, the blood vessel dilation device comprising an elongated microwire including an expandable segment having a distal end and comprising at least two struts having a configuration for allowing blood flow through the vessel, and a tether coupled to the distal end of the expandable segment;

moving the tether at least a first pre-determined distance in a proximal direction to expand the expandable segment to a first pre-set outer diameter to dilate the blocked or constricted portion of the vessel; and

evaluating blood flow through the vessel.

15. The method according to claim 14, further comprising moving the tether at least a second predetermined distance in a proximal direction to expand the expandable segment to a second pre-set outer diameter to further dilate the blocked or constricted portion of the vessel.

16. The method according to claim 14, further comprising releasing the tether to collapse the expandable segment.

17. The method according to claim 14, further comprising removing the blood vessel dilation from the patient'"'"'s body.

18. The method according to claim 14, wherein the expandable segment comprises a maximum pre-set outer diameter substantially equal to or less than an inner diameter of the vessel.

19. A blood vessel dilation device for dilating a blocked or constricted portion of a vessel in a patient'"'"'s body, the device comprising:

an elongated microwire having a proximal end and a distal end and including a lumen extending from the proximal end to the distal end and an expandable segment configured to transition from a collapsed configuration to an expanded configuration, the expandable segment comprising at least two struts having a configuration allowing blood flow through the vessel extending from a proximal end to a distal end of the expandable segment and a maximum pre-set outer diameter substantially equal to or less than an inner diameter of the vessel;

a tether coupled to the distal end of the expandable segment and extending within the lumen to a distance beyond the proximal end of the microwire; and

a handle portion coupled to the proximal end of the microwire and including an incremental adjustment feature coupled to a proximal end of the tether for controllably expanding the expandable segment.

20. The device according to claim 19, wherein the adjustment feature includes a slot having a plurality of equally spaced teeth configured to cooperate with a post coupled to the proximal end of the tether.

21. The device according to claim 19, wherein the adjustment feature includes an outer portion having threadably engaged with an inner portion coupled to the proximal end of the tether, wherein rotation of the outer portion results in movement of the tether in a proximal or distal direction.

22. The device according to claim 19, wherein the adjustment feature further comprises a locking feature for securing the proximal end of the tether at a desired position.

23. The blood vessel dilation device according to claim 19, wherein the expandable segment and the tether are configured such that when the tether is moved a specified distance in a proximal direction, the outer diameter of the expandable segment increases by a proportional amount.

24. The blood vessel dilation device according to claim 19, wherein moving the tether in a proximal direction transitions the expanded segment from the collapsed configuration to the expanded configuration.

25. The blood vessel dilation device according to claim 19, wherein the expandable segment and the tether are configured such that when the tether is moved a predetermined distance in a proximal direction the expandable segment expands to a corresponding pre-set outer diameter.

26. The blood vessel dilation device according to claim 19, wherein the device is deliverable through a delivery catheter.