Treatments for a patient with congestive heart failure

• US 20030120264A1
• Filed: 12/06/2002
• Published: 06/26/2003
• Est. Priority Date: 12/08/2001
• Status: Active Grant

• Current Assignee: Transcardiac Therapeutics Incorporated
• Original Assignee: Transcardiac Therapeutics Incorporated
• Inventors: Lattouf, Omar M.
• Granted Patent: US 7,373,207 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• 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 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 a grasping device through the valve into the left ventricle;

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

e. expanding the stabilizer 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 grasped leaflets with at least one connecting member.

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

3. The method of claim 1 wherein one end of an artificial cordae tendenae strand is secured to the connecting member and a second end of the strand is secured to the ventricular wall to hold the mitral valve in a desired position.

4. The method of claim 3 wherein the strand is secured to the exterior of the 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 non-compliant.

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

8. The method of claim 1 wherein the grasping device has an inner lumen and the valve leaflet stabilizing member is configured to pass through the inner lumen of the grasping device when the stabilizing member is advanced into the patient'"'"'s heart.

9. The method of claim 8 wherein the grasping device has opposed grasping jaws with inner grooves which taper distally to smaller dimensions to close a leaflet connecting member when the connecting member is 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 pacing lead with a penetrating electrode through a small opening in the patient'"'"'s chest cavity to the exposed region of the patient'"'"'s heart wall;

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

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

11. The method of claim 10 wherein a trocar is disposed in the small opening in the patient'"'"'s chest to gain access to the patient'"'"'s chest 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 10 wherein a second pacing lead is disposed in the right ventricle of the patient'"'"' heart and 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.

14. 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; and

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 penetrating electrode of the pacing lead to control the contraction of the heart wall to which the pacing lead in secured.

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

a. a valve configured to be secured within a passageway formed through the patient'"'"'s heart wall to provide 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 secured 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 connecting member to connect free edges of valve leaflets.

16. The minimally invasive system of claim 15 wherein the grasping jaws of the grasping device are configured to grasp the valve leaflets with free edges disposed together to facilitate securing the free edges together with the connecting member.

17. The minimally invasive system of claim 15 including a stabilizing member for engaging valve leaflets and holding the leaflets in a grasping location.

18. The minimally invasive system of claim 17 wherein the stabilizing member is a balloon catheter.

19. The minimally invasive system of claim 18 wherein the balloon catheter has an inflatable balloon on a distal portion thereof.

20. The minimally invasive system of claim 19 wherein the balloon is formed of compliant or semi-compliant polymeric materials.

21. A minimally invasive system for treating a patient'"'"'s heart having a chamber providing insufficient output by securing a penetrating electrode of a pacing lead within an exposed region of a patient'"'"'s free ventricular wall defining in part the patient'"'"'s heart chamber providing insufficient output, comprising:

a. 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 to the distal end and configured to slidably receive a pacing lead.

b. a securing 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'"'"'s heart wall; and

c. a driving member associated with the delivery tube and configured to engage the pacing lead and drive the penetrating electrode of the pacing lead into the exposed wall of the patient'"'"'s heart to secure the penetrating electrode within the heart wall.

22. The minimally invasive system of claim 21 wherein the delivery tube has an expanded distal end.

23. The minimally invasive system of claim 22 wherein the driving member is an inflatable balloon which is disposed within the expanded distal end of the delivery tube.

24. The minimally invasive system of claim 23 wherein the balloon is longitudinally expandable.

25. 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 electrical pulse transmitting member having one end secured to the penetrating electrode of the pacing lead and another end configured to be connected to a source of electrical pulses.

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

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

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

27. The system of claim 26 wherein the strand is formed of a non-compliant polymeric material.

28. The system of claim 27 wherein the polymeric strand is formed of polytetrafluoroethylene and has transverse dimensions of about 1 to about 3 mm.

29. A minimally invasive system for installing a pacing lead to an exposed 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 penetrating electrode on a distal portion of the pacing lead which is securable within the patient'"'"'s heart wall of the exposed region and a collar on the distal portion of the lead proximal to the penetrating electrode;

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

30. The system of claim 29 wherein the driving member is an expandable member at the distal end of the delivery tube configured for distal expansion to engage the collar on the distal portion of the lead to drive the penetrating electrode into the exposed region of the heart wall.

31. The system of claim 29 wherein the delivery tube has a distal portion with larger transverse dimensions than portions of the delivery tube proximal to the distal portion.

32. The system of claim 31 wherein the internal dimension of the distal end of the delivery tube ranges from about 5 to about 15 mm.

33. The system of claim 31 wherein the distal portion of the delivery tube having enlarged transverse dimensions extends a length of about 5 to about 40 mm.

34. The system of claim 29 wherein the securing pod has an inner chamber configured to be connected in fluid communication with a vacuum source.

35. The system of claim 34 wherein the securing pod extends about the distal end of the delivery tube.

36. 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 trocar in the patient'"'"'s chest having a maximum transverse dimension not move with an inner lumen than 20 mm in transverse dimension;

c. 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

d. 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.

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

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

b. tissue grasping means configured to extend through the valve secured within the passageway into the chamber of the patient'"'"'s heart and to grasp valve leaflets; and

c. means to connect free edges of valve leaflets.

38. A minimally invasive system for treating a patient'"'"'s heart having a chamber providing insufficient output by securing a penetrating electrode of a pacing lead within an exposed region of a patient'"'"'s free ventricular wall defining in part the patient'"'"'s heart chamber providing insufficient output, comprising:

a. an elongated tubular delivery means 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 to the distal end and configured to slidably receive a pacing lead;

b. means 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'"'"'s heart wall; and

c. means associated with the delivery tube to engage the pacing lead and drive the penetrating electrode of the pacing lead into the exposed wall of the patient'"'"'s heart to secure the penetrating electrode within the heart wall.

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

a. valve means for accessing a CHF patient'"'"'s left ventricle through a 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; and

c. pacing means having a penetrating electrode secured within a region of the CHF patient'"'"'s free heart wall defining in part the patient'"'"'s left ventricle and a proximal end configured to be electrically connected to an electrical power source to the patient'"'"'s free wall through the penetrating electrode suitable to pace the patient'"'"'s left ventricle.

40. 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 by instruments passing through the valved passageway in the free ventricular wall;

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.

41. A minimally invasive grasping device to secure tissue together with a connecting member comprising:

a. at least a pair of opposed jaws configured to grasp tissue;

b. a pair of operative handles, with each handle being operatively connected to one of the jaws; and

c. an elongated shaft having an inner lumen configured to slidably receive a connecting member.

42. The grasping device of claim 41 wherein at least one of the jaws has a tapering groove to at least partially close the connecting member when the connecting member is advanced distally through the inner lumen into the opposing jaws.

43. The system of claim 41 wherein the connecting member has an open distal end and a closed proximal end.

44. The system of claim 43 wherein an artificial cordae tendenae strand is secured to the closed proximal end of the connecting member.

45. The system of claim 44 wherein the artificial cordae tendenae strand is configured to extend between connected one or more valve leaflets and a heart wall.

46. The system of claim 44 wherein the artificial cordae tendenae strand is formed of non-compliant polymeric material.

47. A pacing lead comprising an elongated electrical pulse transmitting member having a proximal end configured to be connected in an electrical conducting relationship with a source of-electrical pulses, and a distal end having a tissue penetrating electrode with one or more barbs to resist electrode removal from tissue in which the electrode is implanted.

48. The pacing lead of claim 47 wherein the tissue penetrating electrode has an arrow shape.

49. The pacing lead of claim 47 wherein the tissue penetrating electrode has a fish-hook shape.

50. A minimally invasive method for treating a patient having CHF, comprising the steps of:

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 by instruments passing through the valved passageway in the free ventricular wall;

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.

51. A minimally invasive method of treating a patient'"'"' heart having mitral valve regurgitation from a left ventricle, comprising the steps of:

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 a valve leaflet stabilizer member through the valve, through the left ventricle, through the mitral valve into a left atrium distal to the mitral valve;

e. expanding the stabilizer 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 grasped leaflets with at least one connecting member.

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

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

b. advancing a pacing lead with a penetrating electrode through a small opening in the patient'"'"'s chest cavity to the exposed region of the patient'"'"'s heart wall;

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

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

53. A method for treating a patient having a regurgitating heart valve, comprising:

a. securing together free edges of the patient'"'"'s regurgitating heart valve in a “

Bow-Tie”

configuration from within the patient'"'"'s heart; and

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

54. The method of claim 53 including accessing the patient'"'"'s heart chamber in fluid communication with the regurgitating heart valve and securing the free edges of the heart valve together from within the heart chamber.