Treatments for a patient with congestive heart failure

• US 7,513,908 B2
• Filed: 11/22/2005
• Issued: 04/07/2009
• Est. Priority Date: 12/08/2001
• Status: Active Grant

• Current Assignee: Transcardiac Therapeutics Incorporated
• Original Assignee: Transcardiac Therapeutics Incorporated
• Inventors: Lattouf, Omar M.
• Primary Examiner(s): Gherbi; Suzette J
• Application Number:
  US11/285,469
• Publication Number:
  US 20060167541A1
• Time in Patent Office: 1,232 Days
• Field of Search: 607 9- 10
• US Class Current: 623/2.1
• 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 17/0401 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/22068 : Centering
• CPC Class Codes: A61B 2017/22069 : Immobilising; Stabilising
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/320064 : with tissue or sample retaining means
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61F 2/06 : Blood vessels
• CPC Class Codes: A61F 2/24 : Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 : chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 : having means for removal or extraction
• CPC Class Codes: A61N 2001/058 : Fixing tools
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient'"'"'s left ventricular wall at the apex of the patient'"'"'s heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient'"'"'s heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient'"'"'s chest and implanting the pacing lead on an exposed epicardial region of the patient'"'"'s heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

Improved devices for these procedures include a minimally invasive grasping device having an inner lumen for advancing connecting members and other instruments through the device to the distal end thereof. Other improved devices include a pacing lead implant instrument which is releasably secured by its distal end to the exposed heart wall to facilitate penetration of the pacing lead electrode into the heart wall. Other improved instruments include a leaflet connector with an artificial cordae tendenae strand secured to an end of the leaflet connector.

Claims

1. A method for treating a patient having a regurgitating heart valve leading into a heart chamber of the patient'"'"'s heart, comprising:

a. securing together free edges of the patient'"'"'s regurgitating heart valve; and

b. securing one end of an artificial cordae tendenae to the secured free edges of the heart-valve and another end of the artificial cordae tendenae to a heart wall which defines in part the heart chamber.

2. The method of claim 1 including accessing the patient'"'"'s heart chamber into which the regurgitating heart valve leads and securing the free edges of the heart valve together from within the heart chamber.

3. The method of claim 2 wherein access to the patient'"'"'s heart chamber is obtained by forming a small passageway in the patient'"'"'s wall defining in part the patient'"'"'s heart chamber.

4. The method of claim 3 wherein a grasping device having an inner lumen extending therein is advanced through the small passageway formed in the patient'"'"'s heart wall and the valve leaflet stabilizing member is passed through the inner lumen of the grasping device when the stabilizing member is advanced into the patient'"'"'s heart.

5. The method of claim 4 wherein the grasping device has opposed grasping jaws with inner grooves which taper distally to smaller dimensions and which are configured to receive a valve leaflet connecting member.

6. The method of claim 5 wherein one end of the artificial cordae tendenae strand is connected to the valve leaflet connecting member.

7. The method of claim 4 wherein the valve leaflet stabilizer is an expandable element.

8. The method of claim 7 wherein the expandable element of the valve leaflet stabilizer is an inflatable balloon.

9. The method of claim 3 wherein an accessing valve is seated into the passageway formed in the chamber wall.

10. The method of claim 9 wherein a grasping device is advanced through the accessing valve seated into the chamber wall.

11. The method of claim 10 wherein the accessing valve allows for passage of the grasping device into and out of the heart chamber while minimizing blood flow from the heart chamber.

12. The method of claim 10 wherein a valve leaflet stabilizer member is advanced through the heart valve to a location upstream from the heart chamber and then withdrawn to engage leaflets of the heart valve and guide the valve leaflets to a grasping location.

13. The method of claim 12 wherein the grasping device has an inner lumen and the valve leaflet stabilizer is advanced through the inner lumen to the upstream location.

14. The method of claim 12 wherein the valve leaflets in the grasping location are grasped with the grasping device.

15. The method of claim 14 wherein free edges of the grasped valve leaflets are secured together.

16. The method of claim 15 wherein the grasped valve leaflets are secured together with at least one connecting member.

17. The method of claim 1 wherein one end of an artificial cordae tendenae strand is connected to the secured free edges of the valve leaflets and a second end of the artificial cordae tendenae strand is secured to the wall defining in part the heart chamber to hold the valve leaflets in a desired position.

18. The method of claim 17 wherein the second end of the artificial cordae tendenae strand is secured to an exterior portion of the wall defining in part the heart chamber.

19. The method of claim 18 wherein the second end of the artificial cordae tendenae strand extends through the accessing valve in the heart chamber wall.

20. The method of claim 1 wherein the artificial cordae tendenae strand is essentially non-compliant.

21. The method of claim 20 wherein the artificial cordae tendenae strand is formed of a non-compliant material selected from the group consisting of nylon, polyethylene terephthalate and polytetrafluoroethylene.

22. The method of claim 1 wherein the free edges of the patient'"'"'s regurgitating heart valve are secured together in a “

Bow-Tie”

configuration.