Locator and delivery device and method of use

• US 7,361,183 B2
• Filed: 05/21/2004
• Issued: 04/22/2008
• Est. Priority Date: 10/17/2003
• 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.
• Primary Examiner(s): Dawson; Glenn K.
• Application Number:
  US10/850,795
• Publication Number:
  US 20050085856A1
• Time in Patent Office: 1,432 Days
• Field of Search: None
• US Class Current: 606/194
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• 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 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

This invention relates to apparatus and methods for use in sealing a vascular puncture site and to apparatus and methods for properly locating and deploying a sealing device. The locating apparatus includes a lumen which extends from an opening in the distal region of the apparatus but located proximally of the sealing device, which lumen extends to another opening in the proximal region of the device. When the distal opening is in communication with blood in a blood vessel, blood flow through the lumen and out of the proximal opening signifies such location to the user. When the sealing device is withdrawn such that the sealing device is deployed such that it blocks the blood flow into the distal port, the user will know the location of the sealing device. In a preferred embodiment, the sealing device is then withdrawn proximally a predetermined distance to assure that no part of the sealing device extends into the blood vessel lumen. The sealing device is then detached from the delivery device.

Claims

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

an elongate member having a lumen therein and a distal port in a distal region thereof and a proximal port in a proximal region thereof, each of said ports communicating with said lumen in said elongate member,

an obturator housed in said elongate member, a distal portion of said obturator having a relatively large external dimension which is coupled to a shaft which extends proximally from the distal portion thereof, said obturator being provided with a central lumen which extends from the distal end of said obturator proximally through said shaft, a groove in the external surface of the distal portion of the obturator, and

a guidewire extending through said lumen in said elongate member and through said groove, said guidewire having a distal region capable of resisting proximal movement, but being sufficiently flexible to be withdrawn proximally through said groove.

2. The device of claim 1 which is provided with a sealing element in the distal region of the elongate member which is located distally of the distal and of the obturator.

3. The device of claim 2, further comprising

a guidewire tube extending through said lumen in said elongate member, wherein said guidewire is retained within said guidewire tube.

4. The device of claim 3, further comprising

a means for positioning said sealing element in a location near the puncture in the wall of the body lumen.

5. The device of claim 4, wherein said means for positioning comprises a first member attached to said guidewire tube and a second member attached to said guidewire, said first and second members having a spatial relationship that is used to position said sealing element.

6. The device of claim 2, further comprising

a tether extending through the central lumen of said obturator and attached to the sealing element.

7. The device of claim 1, further comprising

an actuator coupled to said elongate member, said actuator adapted to facilitate movement of said elongate member relative to said obturator.

8. A method for substantially sealing an opening in a body lumen, comprising:

inserting at least a distal end of a closure device through a tissue tract into said body lumen,

confirming that at least the distal end of the closure device is in said body lumen by observing blood flow through a lumen in said closure device,

withdrawing the distal end of the closure device from the body lumen such that the closure device remains in the tissue tract, and

deploying a sealing element from said lumen of said closure device.

9. The method of claim 8, wherein said confirming step comprises observing said blood flow out of a proximal port in said lumen of said closure device.

10. The method of claim 9, wherein said blood flow is substantially stopped after a distal port located near the distal end of the closure device is withdrawn from said body lumen.

11. The method of claim 8, further comprising:

positioning said distal end of the closure device at a location in the tissue tract, said location determined at least in part by engaging a portion of a guidewire extending through the closure device to a portion of said body lumen.

12. The method of claim 11, wherein said positioning step comprises:

engaging a distal end portion of the guidewire with a wall of said body lumen, and withdrawing the closure device a predetermined distance after the distal end portion of the guidewire is engaged with the wall of the body lumen.

13. The method of claim 12, further comprising:

confirming that the closure device is withdrawn by the predetermined distance by observing a first member attached to a guidewire tube on said closure device and a second member attached to a guidewire.

14. The method of claim 8, wherein said deploying step comprises moving an elongate member of said closure device proximally while an obturator of said device is held in place, thereby releasing said sealing element from the distal end of the closure device.

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

an elongate member having a distal port, a proximal port, and a passage connecting said distal and proximal ports,

an obturator extending through at least a portion of said elongate member, said obturator having a distal portion adapted to selectively prevent movement of a sealing member in a proximal direction when the elongate member is withdrawn proximally to release said sealing member to seal the puncture of the wall of the body lumen;

a guidewire extending through said elongate member, said guidewire having a transversely disposed portion at a distal region;

a guidewire tube extending through a lumen in said elongate member, wherein said guidewire is retained within said guidewire tube; and

means for positioning said sealing element in a location near the puncture in the wall of the body lumen.

16. The device of claim 15, wherein said means for positioning comprises a first member attached to said guidewire tube and a second member attached to said guidewire, said first member and said second member having a spatial relationship that is used to position said sealing element.

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

an elongate member having a distal port, a proximal port, and a passage connecting said distal and proximal ports,

an obturator extending through at least a portion of said elongate member, said obturator having a distal portion adapted to selectively prevent movement of a sealing member in a proximal direction when the elongate member is withdrawn proximally to release said sealing member to seal the puncture of the wall of the body lumen;

a guidewire extending through said elongate member, said guidewire having a transversely disposed portion at a distal region; and

a central lumen which extends from the distal end of the obturator, and a tether extending through the central lumen of said obturator and attached to the sealing element.