Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ

• US 9,023,065 B2
• Filed: 06/09/2011
• Issued: 05/05/2015
• Est. Priority Date: 11/28/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Aptus Endosystems Inc. (Medtronic Plc)
• Inventors: Bolduc, Lee, Chiang, Andrew L., Houle, Philip R., Laroya, Gilbert S.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US13/157,242
• Publication Number:
  US 20110238088A1
• Time in Patent Office: 1,426 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.16, 623/3.1, 623/3.16, 623/2.11, 623/2.1, 606/151, 606/153, 606/192, 606/194, 606/195, 606/198, 606/139, 606/142, 600 16- 18, 600/37
• US Class Current: 606/142
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• 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 2017/00243 cardiac
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2/2478 : Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2481 : Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall

Abstract

Devices, systems and methods support tissue in a body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques.

Claims

1. A method to reduce the volume or modify the shape of the heart, the method comprising:

providing at least one implant, wherein the implant comprises a helical fastener;

introducing a guide component from a remote access site into the interior of the heart, wherein the guide component has a deflectable distal tip;

advancing an applier instrument through the guide component, wherein the guide component and/or the applier instrument is configured to possess sufficient column strength to resolve at least a portion of an implantation force, and wherein the implantation force comprises a force necessary to cause the helical fastener to penetrate heart tissue;

bracing a distal portion of the guide component against an interior wall of the heart to apply a resolution force to counteract the implantation force; and

rotating the helical fastener into the heart tissue with the applier instrument to anchor the implant to the heart tissue.

2. The method according to claim 1, wherein the implant is configured to engage the applier instrument and the applier instrument is configured to apply the implantation force to cause the helical fastener to penetrate the heart tissue.

3. The method according to claim 2, wherein the implant comprises a tether element.

4. The method according to claim 3, further comprising anchoring at least two implants, wherein each of the at least two implants comprises a tether element.

5. The method according to claim 4, further comprising:

providing a clip;

coupling the tether elements together with the clip; and

applying a tensioning force to the tethering elements, wherein the clip maintains tension of the tethering elements.

6. The method according to claim 1, wherein the guide component is manipulated to provide at least one deflected curve in the distal tip.

7. The method according to claim 1,

wherein the interior wall is a first interior wall of the heart,

wherein the heart tissue forms a portion of a second interior wall of the heart, and

wherein the first interior wall is substantially opposite the second interior wall.