Method and anchor for medical implant placement, and method of anchor manufacture

• US 7,634,319 B2
• Filed: 11/01/2007
• Issued: 12/15/2009
• Est. Priority Date: 07/25/2003
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Schneider, Richard Lee, Goetzinger, David J., Najafi, Nader
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): So; Elizabeth K
• Application Number:
  US11/933,519
• Publication Number:
  US 20080051863A1
• Time in Patent Office: 775 Days
• Field of Search: 607126-128, 600/375, 606/232, 128897-899
• US Class Current: 607/126
• 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 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An anchor and procedure for placing a medical implant, such as for monitoring physiological parameters. The anchor includes a central body in which a medical implant can be received. Arms and members extend radially from first and second ends, respectively, of the central body. Each member defines a leg extending toward distal portions of the arms to provide a clamping action. The anchor and its implant are placed by coupling first and second guidewires to first and second portions of the anchor, placing an end of a delivery catheter in a wall where implantation is desired, inserting the anchor in the catheter with the guidewires to locate the anchor within the wall, deploying the arms of the anchor at one side of the wall followed by deployment of the members at the opposite side of the wall, and thereafter decoupling the guidewires from the anchor.

Claims

1. A method of placing a medical implant, the method comprising the steps of:

inserting a medical implant (12) through an opening (17) in a body portion (16) of an anchor (10) from which a set of arms (22) extend;

coupling at least a first guidewire (40) to a first portion (32) of the anchor (10) and coupling at least a second guidewire (42) to a second portion (34) of the anchor that is disposed between the body and first portions (16,32) of the anchor (10), the anchor having an axis that is coaxial with the first and second guidewires;

placing an end of a delivery catheter (44) through an internal wall of a human body;

inserting the anchor in the delivery catheter with the first and second guidewires so as to place the anchor within the internal wall, cause the arms (22) of the anchor to protrude in a first direction from the end of the delivery catheter, and then cause the arms (22) to extend substantially radially from the anchor;

retracting the first and second guidewires through the delivery catheter in a second direction opposite the first direction, the first and second guidewires being retracted so that the arms (22) of the anchor contact a first side of the internal wall;

retracting the delivery catheter to release a plurality of members (24) coupled to the first portion (32) of the anchor (10), wherein releasing the members (24) causes the members (24) to extend substantially radially from the anchor (10), causes a leg (28) of each of the members (24) to move in the first direction into contact with an oppositely-disposed second side of the internal wall so as to secure the anchor and the medical implant received therein to the internal wall, and causes the first portion (32) of the anchor with the first guidewire (40) coupled thereto to travel toward the second portion (34) of the anchor;

decoupling the first guidewire (40) from the first portion (32) of the anchor; and

then

decoupling the second guidewire (42) from the second portion (34) of the anchor.

2. A method according to claim 1, wherein the body and first portions (16,32) of the anchor are interconnected by the members (24), and the members are collapsed before placing the anchor in the delivery catheter by moving the first and second guidewires in opposite directions.

3. A method according to claim 1, wherein the body and second portions (16,34) of the anchor are rigidly interconnected prior to inserting the medical implant and define an enclosure that contains the medical implant after the medical implant is inserted.

4. A method according to claim 1, where the opening (17) through which the medical implant (12) is inserted into the body portion (16) is located at a first end (18) of the anchor (10).

5. A method according to claim 4, further comprising the step of securing the medical implant within the anchor with fingers located on the first end (18) of the body portion (16).

6. A method according to claim 4, wherein the arms (22) extend from the first end (18) of the anchor.

7. A method according to claim 4, wherein the first portion (32) of the anchor (10) is at an oppositely-disposed second end of the anchor (10).

8. A method according to claim 1, wherein the first and second guidewires (40,42) are coupled to the first and second portions (32,34), respectively, with means (46,48,50,52) comprising at least one element selected from the group consisting of cam slots, threads, snaps, snap latches, latch fingers, spring latches, latch fingers with a catheter sheet for releasing the latch, guidewires, catheters, dissolvable glues, temporary glues, thermal glues, heated shape memory latches, unheated shape memory latches, heated mechanical means, piezoelectric release systems, hydraulic coupling systems, pneumatic coupling systems, and magnetic coupling systems.

9. A method according to claim 1, wherein the first and second portions (32,34) comprise coaxial axially-spaced first and second rings (32,34), respectively.

10. A method according to claim 9, wherein the first guidewire (40) is coupled to the first ring (32) with a cam slot (46) and the second guidewire (42) is coupled to the second ring (34) with threads.

11. A method according to claim 1, wherein the first and second guidewires (40,42) are decoupled from the first and second portions (32,34) of the anchor by moving a member (58) disposed within the first and second guidewires.

12. A method according to claim 11, wherein fingers couple the first and second portions to the first and second guidewires during the insertion step, and movement of the member releases the fingers so as to decouple the first and second portions from the first and second guidewires.

13. A method according to claim 1, wherein the first and second portions are latched together after the arms contact the first side of the internal wall.

14. A method according to claim 1, wherein the medical implant is a cardiovascular implant and the internal wall is a portion of a cardiovascular organ.

15. A method according to claim 14, wherein the internal wall is an atrial septum.

16. A method according to claim 14, wherein placement of the medical implant is used in a procedure performed to diagnose, monitor, and/or treat a cardiovascular disease.

17. A method according to claim 1, wherein placement of the medical implant is used in a procedure performed to diagnose, monitor, and/or treat an internal organ.

18. A method according to claim 1, wherein the implant is received within and secured to the body portion (16), and the implant is communicatively connected to a medical device.

19. A method according to claim 18, wherein the medical device is a pacemaker.

20. A method according to claim 18, wherein the implant is communicatively connected to the medical device by a communication connection selected from the group consisting of electrical wires, pacemaker leads, flexible cables, optical connectors, ultrasonic pads, and electrophysiology signals.