Treatment for patient with congestive heart failure

• US 6,978,176 B2
• Filed: 11/15/2002
• Issued: 12/20/2005
• Est. Priority Date: 12/08/2001
• Status: Expired due to Fees

• Current Assignee: Transcardiac Therapeutics Incorporated
• Original Assignee: Omar M. Lattouf
• Inventors: Lattouf, Omar M.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/295,390
• Publication Number:
  US 20030130571A1
• Time in Patent Office: 1,131 Days
• Field of Search: 607/3, 607 9- 10, 607/119, 607126-131, 623/2.1, 623/2.11, 623/2.12, 128/897, 128/899, 600/16
• US Class Current: 607/9
• 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

Two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, may be performed separately or together. 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. 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. Improved devices for these procedures include a minimally invasive grasping device for heart leaflets, a leaflet connector with artificial cordae tendenae and a pacing lead implant instrument.

Claims

1. A minimally invasive method of treating a patient heart having mitral valve regurgitation from a left ventricle, comprising:

a. forming a small passageway in the patient'"'"'s left ventricular wall defining in part the patient'"'"'s left ventricle;

b. seating a valve into the passageway formed in the left ventricular wall;

c. advancing grasping device through the valve into the left ventricle;

d. advancing an expendable member through the valve, through the left ventricle, through the mitral valve into a left atrium distal to the mitral valve;

e. expanding the expandable member within the left atrium and engaging leaflets of the mitral valve and guiding the leaflets to a grasping location;

f. grasping the leaflets in the grasping location with the grasping device; and

g. securing together free edges of the leaflets grasped with one or more connecting members.

2. The method of claim 1 wherein the seated valve allows for passage of instrument into and out of the left ventricle and minimizes blood flow from the left ventricle.

3. The method of claim 1 wherein a strand is secured to the by one end thereof to one or more of the connecting members and by a second end to the ventricular wall to hold the mitral valve in a desired position.

4. The method of claim 1 wherein the strand is secured to the exterior of ventricular wall.

5. The method of claim 4 wherein the strand passes through the seated valve in the ventricular wall.

6. The method of claim 3 wherein the strand is relatively non-compliant.

7. The method of claim 5 wherein the strand is formed of a material selected from the group consisting of nylon, polyethylene terephthalate, polytetrafluoroethylene, and polyurethane.

8. The method of claim 1 wherein the grasping device has an inner lumen and the expandable member passes through the inner lumen of the grasping device to advanced into the patient'"'"'s heart.

9. The method of claim 8 wherein the inner lumen tapers to smaller dimension in the distal direction within the grasping elements to close a leaflet clip when distally advanced therein.

10. A minimally invasive method of treating a patient'"'"'s heart which has a left ventricle that provides insufficient output, comprising:

a. exposing an exterior region of the patient'"'"'s heart wall which defines in part the left ventricle;

b. advancing a delivery tube until a distal end of the delivery tube engages the exterior region of the patient'"'"'s heart wall;

c. releasably securing the distal end of the delivery tube to engaged exterior region of the patients'"'"'s heart;

d. advancing a pacing lead with a penetrating electrode through an inner lumen of the delivery tube to the exposed region of the patient'"'"'s heart wall;

e. securing the penetrating eletrode of the pacing lead within the patient'"'"'s heart wall; and

f. delivering electrical pulses to the penetrating electrode of the pacing lead to control the contraction of the heart wall to which the pacing lead is secured.

11. The method of claim 10 wherein a small opening is formed in the patient'"'"'s chest to gain access to the patient'"'"'s cheat cavity.

12. The method of claim 10 wherein the electrical pulses have a frequency, duration, current and voltage sufficient to control the contraction of the patient'"'"'s left ventricle to increase the output thereof.

13. The method of claim 11 wherein a trocar is seated within the small opening in the patient'"'"'s chest.

14. The method of claim 10 wherein a second pacing lead is disposed in a heartwall defining in part the right ventricle of the patient'"'"' heart and wherein electrical pulses are emitted from an electrode on a distal portion of the second pacing lead having a frequency, duration, current and voltage sufficient to control the contraction of the right ventricle to increase the output thereof.

15. The method of claim 10 wherein the distal end of the delivery tube is releasable secured to the engaged exterior region of the patients heart by vacuum.

16. The method of claim 15 wherein the distal end of the delivery tube has a housing defining a vacuum chamber with at least one opening to releasable secure the distal end of the delivery tube to the engaged exterior region of the patients heart.

17. A method of treating a patient'"'"'s heart with congestive heart failure due at least in part to regurgitation through a mitral valve and ventricular conduction delay with resulting disturbance of the synchronous ventricular contractility, comprising:

a. forming a small passageway in the patient'"'"'s left ventricular wall defining in part the patient'"'"'s left ventricle;

b. seating a valve into the passageway formed in the left ventricular wall;

c. advancing a grasping device through the valve into the left ventricle;

d. advancing an expandable member through the valve, through the left ventricle, through the mitral valve into a left atrium distal to the mitral valve;

e. expanding the expandable member within the left atrium and engaging leaflets of the mitral valve and guiding the leaflets to a grasping location;

f. grasping the leaflets in the grasping location with the grasping device;

g. securing together free edges of the leaflets grasped with one or more connecting members;

h. exposing an exterior region of the patient'"'"'s heart wall which defines in part the left ventricle;

i. advancing a pacing lead with a penetrating electrode through the patient'"'"'s chest cavity to an exposed region of the patient'"'"'s heart wall;

j. securing the pacing lead to the exposed region of the patient'"'"'s heart wall with the penetrating electrode within the heart wall; and

k. delivering electrical pulses to the pacing lead to control the contraction of the heart wall to which the pacing lead in secured.

18. A minimally invasive system for treating a patient'"'"'s heart having heart valve regurgitation, comprising:

a. a valve body which is disposed within a passageway formed through the patient'"'"'s heart wall to provide an instrument passageway into a chamber of the patient'"'"'s heart defined in part by the heart from a location within the patient'"'"'s chest cavity, which is secured to the patient'"'"'s heart wall and which has a valve element to prevent lost of blood flow through the valve body;

b. a tissue grasping device configured to extend through the valve body disposed within the passageway into the chamber of the patient'"'"'s heart and having at least two grasping members configured to grasp valve leaflets; and

c. a tissue securing assembly configured to pass through the valve body to secure a tissue connecting member to at least one free edge of a valve leaflet.

19. The minimally invasive system of claim 18 wherein the grasping laws of the grasping device grasp the valve leaflets with free edges exposed to facilitate securing the free edges together with the connecting member.

20. A minimally invasive system for treating a patient'"'"'s heart having a chamber providing insufficient output, comprising:

a. a valve configured to be secured within a passageway formed through the patient'"'"'s heart wall to provide an instrument passageway into a chamber of the patient'"'"'s heart defined in part by the heart wall through which the passageway is formed;

b. a tissue grasping device configured to extend through the valve into the chamber of the patient heart and to grasp free edges of valve leaflets;

c. a tissue securing assembly advanceable through the valve to secure one or more connecting members to at least one free edge of a valve leaflet;

d. a pacing lead configured to be advanced into the patient'"'"'s chest cavity through a small opening in the patient'"'"'s chest an to be secured to an exterior region of the patient'"'"'s heart; and

e. an elongated pulse transmitting member having one end secured to the pacing lead and another end configured to be connected to a source of energy pulses.

21. A system for treating a patient with congestive heart failure including a regurgitating heart valve, comprising:

a. at least one connecting member for securing together free edges of the patient'"'"'s regurgitating heart valve; and

b. at least one strand having one end secured to the at least one connecting member and one end configured to be secured to a heart wall.

22. A minimally invasive system for installing a pacing lead to an exterior region of a free wall of a patient'"'"'s heart, comprising:

a. a delivery tube having a proximal end, a port in the proximal end, a distal end, a port in the distal end, an inner lumen extending from the proximal end to the distal end and in fluid communication with the ports therein and a securing pod on the distal end to releasably secure the distal end of the delivery tube to the exterior region of the patient'"'"'s free heart wall;

b. a pacing lead slidably disposed within the inner lumen of the delivery tube with a distal electrode which is securable within the patient'"'"'s heart wall of the exterior region and a collar on the lead proximal to the distal electrode; and

c. configured;

d. a driving member on the distal end of the delivery tube configured to engage the collar on the lead and drive the electrode of the lead into the heart wall of the exposed region of the patient'"'"'s heart.

23. A method of treating a patient having CHF, comprising:

a. providing a pacing lead having a pulse emitting electrode on the distal end thereof;

b. advancing the pacing lead through a small opening in the patient'"'"'s chest;

c. passing the pacing lead through an inner lumen of a delivery tube which has a distal end releasably secured to a region of the patient'"'"'s heart wall defining in part the patient'"'"'s heart left ventricle;

d. securing the pulse emitting electrode on the distal end of the pacing lead within a free wall of the patient'"'"'s heart defining in part the patient'"'"'s left ventricle; and

e. emitting electrical pulses from the electrode to pace the contractions of the patient'"'"'s left ventricle to increase the blood flow out of the left ventricle.

24. A minimally invasive system for delivering a pacing lead to an exposed region of a patient'"'"'s free ventricular wall defining in part the patient'"'"'s left ventricle, comprising:

a. an elongated pacing lead having a distal end with a ventricular wall penetrating electrode and a distal end configured to be connected to an electrical conducting relationship with a suitable pacing power source;

b. an elongated delivery tube having a proximal end, a distal end configured to pass through a small opening in the patient'"'"'s chest, an inner lumen extending through the delivery tube configured to slidably receive the pacing lead and a vacuum pod on the distal end of the delivery tube to releasably secure the distal end of the delivery tube to the exposed region of the patient heart wall; and

c. a driving member on a distal portion of the delivery tube configured to engage the pacing lead and drive the tissue penetrating electrode through the exposed surface of the patient'"'"'s heart wall to secure the electrode within the heart wall.

25. The minimally invasive system of claim 24 wherein the delivery tube has an expanded distal end.

26. The minimally invasive system of claim 25 wherein the driving member is an inflatable balloon which is disposed within the expanded distal end of the delivery tube.

27. A minimally invasive system for treating a patient having CHF, comprising:

a. means for accessing a CHF patient'"'"'s left ventricle through a valved passageway in the free ventricular wall defining in part the patient'"'"'s left ventricle;

b. means for securing together free edges of the patient'"'"'s mitral valve in a “

Bow-Tie”

configuration from within the patient'"'"'s left ventricle;

c. pacing means having an electrode secured within a region of the CHF patient'"'"'s free heart wall defining in part the patient'"'"'s left ventricle; and

d. an electrical power source electrically connected to the pacing means to deliver electrical pulses to the patient'"'"'s free wall suitable to pace the patient'"'"'s left ventricle.

28. A minimally invasive method for treating a patient having CHF, comprising:

a. accessing a CHF patient'"'"'s left ventricle through a valved passageway in the free ventricular wall defining in part the patient'"'"'s left ventricle;

b. securing together free edges of the patient'"'"'s mitral valve in a “

Bow-Tie”

configuration from within the patient'"'"'s left ventricle;

c. securing an electrode of a pacing lead within a region of the CHF patient'"'"'s free heart wall defining in part the patient'"'"'s left ventricle; and

d. delivering electrical pulses from an electrical power source to the pacing lead to deliver electrical pulses to the patient'"'"'s free wall suitable to pace the patient'"'"'s left ventricle.

29. A minimally invasive system for installing a pacing lead to an exterior region of a free wall of a patient'"'"'s heart, comprising:

a. a delivery tube having a proximal end, a port in the proximal end, a distal end, a port in the distal end, an inner lumen extending from the proximal end to the distal end and in fluid communication with the ports therein and a securing pod on the distal end configured to releasably secure the distal end of the delivery tube to the exterior region of the patient'"'"'s free heart wall; and

b. a pacing lead slidably disposed within the inner lumen of the delivery tube with a distal eletrode which is securable within the patients'"'"'s heart wall of the exterior region.

30. The minimally invasive system of claim 29 wherein driving member is configured to engage the lead and drive the eletrode of the lead into the heart wall of the exposed region of the patient'"'"'s heart.

31. The minimally invasive system of claim 30 wherein the distal portion of the lead has collar configured to engage the driving member.

32. The minimally invasive system of claim 31 wherein an expandable member on the delivery tube is configured to engage the collar on the lead and to drive the distal eletrode of the lead into the heart wall of the exterior region.

33. The minimally invasive system of claim 29 wherein the delivery tube has a housing on the distal end thereof which defines a vacuum chamber having at least one opening configured to engage the exposed region of the patient'"'"'heart and be releasably secured to the exposed region upon the formation of a vacuum within the vacuum chamber.

34. The minimally invasive system of claim 33 wherein a vacuum lumen is in fluid communication with the vacuum chamber.

35. The minimally invasive system of claim 34 wherein the vacuum lumen extends to a proximal portion of the system and is configured to be connected in fluid communication with a vacuum source.

36. The minimally invasive system of claim 33 wherein the housing defining the vacuum chamber encircles the distal end of the delivery tube.

37. The minimally invasive system of claim 36 wherein the housing is an annular pod secured to the distal end of the delivery tube.

38. The method for treating a patient with a regurgitating heart valve, comprising:

a. providing connector having a connecting member and at least one strand having a first end secured to the connecting member and a free unsecured portion;

b. securing together free edges of the patient'"'"'s regurgitating heart valve with at least one connecting member; and

c. securing the free unsecured portion of at least one strand secured to the connecting member to a heart wall.