VASCULAR CLOSURE WITH MULTIPLE CONNECTIONS

• US 20140114347A1
• Filed: 10/17/2013
• Published: 04/24/2014
• Est. Priority Date: 10/19/2012
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Stanley, Cleon, Paul, Ram H. Jr., Griffin, Dennis
• Granted Patent: US 10,070,850 B2
• Time in Patent Office: Days
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor

Abstract

Among other things, methods and apparatus for inserting devices for closing a tissue opening are disclosed. An anchoring or sealing member has one or more stems and/or filaments that are offset from the center of the member, so that lateral adjustments or movements of the anchoring or sealing member do not uncover the opening, cause the anchoring or sealing member to stick through or pull through the opening. Embodiments including a valve adapted to accommodate a guide wire for addressing emergencies are also disclosed.

Claims

1. A medical treatment device for a tissue opening in a patient, comprising:

an anchoring member adapted for engagement with tissue bordering the tissue opening; and

at least first and second filaments connected to the anchoring member and adapted to extend from the anchoring member to a position outside of the patient so that pulling one or more of the filaments tends to engage or press the anchoring member against the tissue,

wherein the anchoring member has a center point inside at least one edge, and wherein the connection of the first filament and the anchoring member is offset laterally in a first direction from the center point, and the connection of the second filament and the anchoring member is offset laterally in a second direction from the center point, the first and second direction substantially opposed to each other, and wherein the distance between the first and second filaments is less than or equal to a dimension of the tissue opening.

2. The apparatus of claim 1, wherein the anchoring member includes at least first and second stems monolithic with the remainder of the anchoring member, wherein the first filament is attached to the first stem and the second filament is attached to the second stem.

3. The apparatus of claim 2, wherein the anchoring member has a major axis through the center point and extending between first and second ends of the anchoring member, and wherein the first and second stems are on the major axis.

4. The apparatus of claim 3, wherein the first and second stems are equidistant from the center point.

5. The apparatus of claim 1, wherein the anchoring member includes at least four stems, each having a respective filament, each of said stems displaced from the center point by approximately the same distance, and each of the stems separated from adjacent stems by approximately the same angle.

6. The apparatus of claim 1, wherein the anchoring member includes a hemostatic valve adapted to permit passage of a guidewire therethrough, the valve substantially preventing blood flow through the anchoring member.

7. The apparatus of claim 6, wherein the valve is substantially at the center point.

8. The apparatus of claim 6, wherein the valve is offset from each of said first and second filaments.

9. The apparatus of claim 6, further comprising a guide wire extending through the valve.

10. A medical treatment device for a tissue opening in a patient, comprising:

an anchoring member adapted for engagement with tissue bordering the tissue opening, the anchoring member including a wall, the wall having a valve portion allowing penetration through the wall and providing hemostatic control;

a guide wire inserted through the valve so that a portion of the guide wire is on either side of the wall, wherein when the anchoring member is engaged with tissue bordering the tissue opening, a portion of the guide wire extends through the opening.

11. The apparatus of claim 10, wherein the anchoring member includes at least one stem monolithic with the wall and offset from the valve.

12. The apparatus of claim 11, further comprising a pusher with a lumen, the pusher configured to move over the stem with at least a portion of the stem within the lumen, the pusher having a forward portion that is inwardly tapered.

13. The apparatus of claim 10, wherein a filament is connected with the stem, and further comprising a pusher with a lumen, the pusher configured to move over the stem and filament with at least a portion of the stem and at least portion of the filament within the lumen, and further comprising an indicator fixed with respect to at least one of the stem and filament and at least partially within the pusher, the indicator having at least a portion contrasting with the pusher, wherein the indicator is positioned to exit from the pusher as the pusher is moved along at least one of the stem and the filament so that the contrasting portion exits from the pusher at a point at which the pusher has moved a desired distance.

14. The apparatus of claim 10, wherein the anchoring member includes at least first and second stems joined to the wall and offset from the valve, wherein the first and second stems and the valve are along a line.

15. The apparatus of claim 14, wherein a first distance between the first stem and the valve and a second distance between the second stem and the valve are substantially the same.

16. The apparatus of claim 14, wherein the distance between the first and second stems is equal to or less than a dimension of the tissue opening.

17. The apparatus of claim 14, further comprising a first filament connected to the first stem and a second filament connected to the second stem.

18. The apparatus of claim 10, further comprising at least one filament connected to the anchoring member and offset from the valve.

19. A method of treating an opening in tissue, comprising:

inserting through the opening a medical treatment device having an anchoring member and at least first and second filaments connected to the anchoring member and adapted to extend from the anchoring member to a position outside of the patient, the anchoring member having a center point, with the connection of the first filament and the anchoring member offset laterally in a first direction from the center point, and the connection of the second filament and the anchoring member offset laterally in a second direction from the center point, the first and second directions substantially opposed to each other, so that the first and second filament extend to a location outside the patient;

providing tension on the first and second filaments so that the anchoring member is firmly engaged with tissue adjacent the opening, one or more of the anchoring member and the filaments preventing movement of the anchoring member with respect to the opening to the degree that an end of the anchoring member is within the hole;

locking the anchoring member in place with respect to the tissue.

20. The method of claim 19, wherein the anchoring member includes first and second stems and the first filament is attached to the first stem and the second filament is attached to the second stem, and wherein the inserting step includes placing the anchoring member so that the first and second stems both extend through the hole so that the stems limit movement of the anchoring member with respect to the hole.

21. The method of claim 19, wherein the inserting step includes the anchoring member having a hemostatic valve and a guide wire extending through the valve, and further comprising:

monitoring the treatment of the tissue opening, and where an emergency is detected, applying a medical device over the guide wire to one or both of the tissue and the hole.