TREATMENTS FOR A PATIENT WITH CONGESTIVE HEART FAILURE
First Claim
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.
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Accused Products
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.
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Citations
54 Claims
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1. A minimally invasive method of treating a patient'"'"' heart having mitral valve regurgitation from a left ventricle, comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A minimally invasive method of treating a patient'"'"'s heart which has a left ventricle that provides insufficient output, comprising:
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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. - View Dependent Claims (11, 12, 13)
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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.
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15. A minimally invasive system for treating a patient'"'"'s heart having heart valve regurgitation, comprising:
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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. - View Dependent Claims (16, 17, 18, 19, 20)
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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:
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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. - View Dependent Claims (22, 23, 24)
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25. A minimally invasive system for treating a patient'"'"'s heart having a chamber providing insufficient output, comprising:
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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.
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26. A system for treating a patient with congestive heart failure including a regurgitating heart valve, comprising:
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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. - View Dependent Claims (27, 28)
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29. A minimally invasive system for installing a pacing lead to an exposed region of a free wall of a patient'"'"'s heart, comprising:
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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. - View Dependent Claims (30, 31, 32, 33, 34, 35)
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36. A method of treating a patient having CHF, comprising:
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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.
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37. A minimally invasive system for treating a patient'"'"'s heart having heart valve regurgitation, comprising:
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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.
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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:
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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.
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39. A minimally invasive system for treating a patient having CHF, comprising:
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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; andc. 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.
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40. A minimally invasive method for treating a patient having CHF, comprising:
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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.
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41. A minimally invasive grasping device to secure tissue together with a connecting member comprising:
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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. - View Dependent Claims (42, 43, 44, 45, 46)
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- 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.
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50. A minimally invasive method for treating a patient having CHF, comprising the steps of:
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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.
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51. A minimally invasive method of treating a patient'"'"' heart having mitral valve regurgitation from a left ventricle, comprising the steps of:
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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.
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52. A minimally invasive method of treating a patient'"'"'s heart which has a left ventricle that provides insufficient output, comprising the steps of:
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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.
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53. A method for treating a patient having a regurgitating heart valve, comprising:
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a. securing together free edges of the patient'"'"'s regurgitating heart valve in a “
Bow-Tie”
configuration from within the patient'"'"'s heart; andb. 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. - View Dependent Claims (54)
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Specification