Locator and closure device and method of use

• US 8,088,144 B2
• Filed: 10/05/2005
• Issued: 01/03/2012
• Est. Priority Date: 05/04/2005
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Ensure Medical, Inc. (Cardinal Health, Inc.)
• Inventors: Ginn, Richard S., Palermo, Thomas J.
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US11/244,944
• Publication Number:
  US 20060253037A1
• Time in Patent Office: 2,281 Days
• Field of Search: 606/213, 606/108, 606192-194, 606/1, 606/66, 606/167, 606/190, 606/216, 604/22, 604/164.01, 604/264, 74/29, 741/09, 744/20, 744/22, 744/246, 600/585
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2090/0807 Indication means

Abstract

A device which is capable of both locating a punctured blood vessel wall and sealing the puncture in the vessel and a method of using the device. In one embodiment, the device includes an elongate deployment member having a releasable sealing element disposed within a distal end and an elongated indicator member having a proximal end and a distal end. The deployment member is coupled to a first actuator configured to retract the deployment member relative to the sealing element. The indicator member extends through a lumen in the deployment member such that the distal end of said the indicator member extends distally of the distal end of the deployment member. The indicator member is also coupled to a second actuator configured to retract the indicator member relative to the deployment member.

Claims

1. A device for sealing a puncture in the wall of the body lumen comprising:

an elongate deployment member having a sealing element releasably disposed within a distal end thereof, the deployment member being coupled to a first actuator configured to retract the deployment member relative to the sealing element, and an elongated indicator member having a proximal end and a distal end configured to provide resistance to a withdrawal force when the distal end engages the wall of the body lumen, the indicator member extending through a lumen in the deployment member such that the distal end of the indicator member extends distally of the distal end of the deployment member and can be completely withdrawn to a location proximal of the sealing element, and the indicator member being coupled to a second actuator configured to retract the indicator member relative to the sealing element, wherein the first and second actuators are encased in a housing having a trigger configured to actuate the first and second actuators in one movement.

2. The device of claim 1, wherein the first and second actuators are first and second gears, further wherein the first and second gears form first and second rack and pinion mechanisms respectively.

3. The device of claim 2, wherein the diameter of the first gear is substantially smaller than the diameter of the second gear.

4. The device of claim 2, wherein the rack and pinion mechanisms each have a mechanical advantage and the ratio of mechanical advantages for the first rack and pinion mechanism to the second rack and pinion mechanism is 2 to 1.

5. The device of claim 2, wherein the rack and pinion mechanisms each have a mechanical advantage and the ratio of mechanical advantages for the first rack and pinion mechanism to the second rack and pinion mechanism is 3 to 1.

6. The device of claim 1, wherein the first and second actuators are hydraulic devices.

7. The device of claim 1, wherein the housing further includes an indicator configured to notify an operator when the distal end of the indicator member is positioned at a desirable location within the puncture.

8. The device of claim 7, wherein the indicator includes an LED that emits a light when the distal end of the indicator member is positioned at a desirable location within the puncture.

9. The device of claim 7, wherein the indicator includes a window and the proximal end of the indicator member is coupled to an indicator marker located below the window, wherein the indicator marker moves to a predetermined position within the window when the distal end of the indicator member is positioned at a desirable location within the puncture.

10. The device of claim 1, wherein the housing includes an audio alarm operatively coupled to the indicator member that emits a sound when the distal end of the indicator member is positioned at a desirable location within the puncture.

11. The device of claim 10, wherein the desirable location is adjacent to an edge of the puncture.

12. The device of claim 1, wherein said device comprises a bleed back conduit defined in the deployment member.

13. The device of claim 1, wherein the first and second actuators are configured to withdraw the deployment member and indicator member respectively at different rates, wherein the rate of withdrawal for the indicator member is greater than the rate of withdrawal for the deployment member.

14. The device of claim 1, further comprising:

a lock out plate coupled to the trigger and configured to prevent the trigger from substantial movement; and

an indicator spring coupled to the lock out plate and configured to disengage the lock out plate from the trigger when the distal end of the indicator member is positioned at a desirable location within the puncture.

15. The device of claim 1, wherein the indicator member is a wire that includes a distal end that is configured to form a loop when extended out of the deployment tube.

16. The device of claim 1, further comprising a pusher received by the deployment member, wherein the pusher supports the sealing element at a particular location within the deployment member.

17. The device of claim 1, further comprising an inlet port coupled toward the distal end of the deployment member, configured to take in blood when exposed to a vessel, and an outlet port communicatively coupled to the inlet port configured to allow the blood that entered the inlet port to exit.

18. The device of claim 1, wherein the sealing element is expandable.

19. The device of claim 1, wherein the sealing element is comprised of bioabsorbable material.

20. The device of claim 1, further comprising a wire actuator coupled to a distal section of the housing and engaged to the indicator member such that when the wire actuator is pushed toward the housing, the indicator member is pushed in the distal direction.

21. The device of claim 1, wherein the device is configured to be engaged with an introducer sheath.

22. A method for sealing a puncture, having an edge, in the wall of a lumen of a body comprising:

deploying a deployment member of a sealing device through the puncture, wherein the sealing device includes a sealing element and an indicator wire having a distal tip;

extending the indicator wire out of the deployment member when the sealing device is deployed through the puncture;

adjusting the position of the sealing device until the indicator wire is adjacent to the edge of the puncture by engaging the wall of the body lumen with the distal tip of the indicator wire such that it resists a withdrawal force;

retracting the indicator wire into the device so that the distal tip is positioned proximal of the sealing element, wherein the indicator wire is retracted within the deployment member by the use of a first actuator prior to retracting the deployment member relative to the sealing element by the use of the second actuator; and

retracting the device from the puncture.

23. The method of claim 22, wherein the indicator wire is retracted at a faster rate than the rate of retraction of the deployment member.

24. The method of claim 22, wherein the distal tip of the indicator wire forms a loop when deployed out of the sealing device.

25. The method of claim 22, wherein the first and second actuators are first and second gears, further wherein the first and second gears form first and second rack and pinion mechanisms respectively.

26. The method of claim 25, wherein the diameter of the second gear is substantially smaller than the diameter of the first gear.

27. The method of claim 22, wherein the first and second actuators are hydraulic devices.

28. The method of claim 22, further comprising the step of notifying an operator when the distal end of the indicator wire is positioned at the edge of the puncture.

29. The method of claim 28, wherein notifying the operator includes emitting an LED light.

30. The method of claim 28, wherein notifying the operator includes invoking an audio alarm.