JP4456605B2 - Method and apparatus for improving mitral valve function - Google Patents

Description

Related applications

This application
(1) Daniel C. In a continuation-in-part of pending US application Ser. No. 10 / 068,264 filed Feb. 5, 2002 by Taylor et al., Entitled “Method and Apparatus for Improving Mitral Valve Function”. Yes,
(2) One of pending prior US patent application Ser. No. 10 / 112,354, filed Mar. 29, 2002 by John Liddicoat et al. Entitled “Method and apparatus for improving mitral valve function”. Part continuation application,
(3) Daniel C. In a continuation-in-part of pending US patent application Ser. No. 10 / 218,649, filed Aug. 14, 2002 by Taylor et al., Entitled “Method and Apparatus for Improving Mitral Valve Function”. Yes,
(4) Daniel C. In a continuation-in-part of pending US application Ser. No. 10 / 068,264 filed Feb. 5, 2002 by Taylor et al., Entitled “Method and Apparatus for Improving Mitral Valve Function”. Yes,
(5) Daniel C. In a continuation-in-part application of pending earlier US patent application Ser. No. 10 / 342,034 filed Jan. 14, 2003 by Taylor et al. Entitled “Method and apparatus for improving mitral valve function”. Yes,
(6) William E.M. In a continuation-in-part application of pending prior US patent application 60 / 391,790 filed June 26, 2002 by Cohn et al. Entitled "Method and apparatus for improving mitral valve function". is there.

  These six above-mentioned applications are hereby incorporated by reference.

Field of Invention

  The present invention relates generally to surgical methods and devices, and more particularly to surgical methods and devices for improving mitral valve function.

  Mitral valve replacement is a selective procedure to correct mitral regurgitation for all etiologies. The use of current surgical techniques can repair mitral valves that are experiencing 70% to 95% reflux. The benefits of mitral valve repair over mitral valve replacement are well documented. These benefits include better preservation of cardiac function and a lower risk of bleeding, thromboembolism and endocarditis associated with anticoagulant factors.

  In current practice, mitral valve surgery requires an incision in the chest wall, cardiopulmonary bypass, cardiopulmonary arrest, and the heart itself to gain access to the mitral valve. Such treatment is associated with high morbidity and mortality. Because of the risks associated with this procedure, many of the most severely ill patients negate the potential benefits of surgical correction of mitral regurgitation. In addition, patients with moderately symptomatic mitral regurgitation undergo surgical correction only after early intervention has been rejected and cardiac dysfunction has progressed.

  Mitral regurgitation is a common symptom in patients with cardiac defects and is an important source of morbidity and mortality in these patients. Mitral regurgitation in patients with heart defects is caused by changes in the geometry of the left ventricle, papillary muscles, and mitral annulus. These geometric changes result in incomplete jointing of the mitral valve membrane during systole. In this situation, mitral regurgitation can be performed either by suturing alone or by suturing in combination with a support ring to reduce the periphery of the elongated annulus and restore the original geometric structure of the mitral annulus. It is corrected by fanning the cap annulus.

  More specifically, current surgical procedures for mitral valve repair generally involve surgically opening the left ventricle and then securing the suture, more commonly a suture combined with a support ring. By fixing to the inner surface of the annulus, it is necessary to reduce the radius of the mitral annulus, and this structure tightens the annulus in a purse-like form to a smaller radius, thereby reducing the valve leaflet. Reduce mitral regurgitation by improving the joint.

  This mitral valve repair method is commonly referred to as “annuloplasty” and effectively reduces mitral regurgitation in patients with heart defects. Reduce heart defect symptoms, improve life quality and prolong life. Unfortunately, however, the invasiveness and associated risks of mitral valve surgery make most patients with heart defects unhappy candidates. In this way, a less invasive means of increasing valvular junctions and thereby reducing mitral regurgitation in patients with heart defects makes this treatment method available to a higher percentage of patients.

  Mitral regurgitation also occurs in almost 20% of patients suffering from acute myocardial infarction. In addition, mitral regurgitation is a major cause of heart shock in about 10% of patients with severe hemodynamic instability in acute myocardial infarction clotting. Patients with mitral regurgitation and heart shock have a mortality of about 50% etiology. The elimination of mitral regurgitation in these patients has significant advantages. Unfortunately, however, patients suffering from acute mitral regurgitation with complicated acute myocardial infarction are particularly high risk surgical candidates and are therefore good candidates for traditional annuloplasty procedures. Not a candidate. Therefore, the least invasive means to provide a temporary reduction or elimination of mitral regurgitation in these dangerously ill patients is based on myocardial infarction or other acute life-threatening phenomena. Gives time to recover and make better candidates for medical intervention or surgical treatment.

It is an object of the present invention to provide an improved method and apparatus for reducing mitral valve regurgitation.
Another object of the present invention is to provide a method and apparatus for reducing invasive mitral regurgitation.

  Yet another object of the present invention is to permanently (e.g., for a patient having a cardiac defect) or temporarily (e.g., to a patient suffering from mitral regurgitation due to acute myocardial infarction). It is to provide a method and apparatus for reducing mitral regurgitation that can be deployed.

These and other objects are achieved by the present invention including an improved method and apparatus for reducing mitral regurgitation.
In one form of the invention, a method is provided for reducing mitral regurgitation, the method comprising inserting a device near the posterior leaflet of the mitral valve in the patient's coronary sinus; The device is adapted to straighten at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, thereby moving the posterior annulus forward to improve valvular junctions.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising inserting the device near the posterior leaflet of the mitral valve in the patient's coronary sinus. The device is adapted to move at least a portion of the coronary sinus near the posterior leaflet of the mitral valve forward, thereby moving the posterior annulus forward to improve valvular junctions.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising inserting the device near the posterior leaflet of the mitral valve in the patient's coronary sinus. And the device reduces the inherent curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve, thereby moving the posterior annulus forward to improve valvular junction Has been made.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising inserting the device near the posterior leaflet of the mitral valve in the patient's coronary sinus. This device increases the natural curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve, thereby moving the posterior annulus forward to improve the valve joint Has been made.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising inserting the device near the posterior leaflet of the mitral valve in the patient's coronary sinus. The device has a distal end, a proximal end, and an intermediate portion, and the distal end and proximal end are posteriorly disposed when placed near the posterior leaflet of the mitral valve in the coronary sinus. A force is applied to the wall of the coronary sinus, and the intermediate portion applies an anterior force to the wall of the coronary sinus, thereby moving the posterior annulus forward to improve valvular junction.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising an elongated body that is generally straight near the posterior leaflet of the mitral valve in a patient's coronary sinus. The length of the substantially straight elongate body is relative to the original curve of the coronary sinus near the leaflet behind the mitral valve and the substantially straight elongate body is within the coronary sinus. When deployed, causes at least a portion of the coronary sinus to have a generally straight shape adjacent to the posterior leaflet of the mitral valve, thereby increasing the radius of curvature of the mitral annulus and The length is set to improve the joining.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising inserting the device near the posterior leaflet of the mitral valve in the patient's coronary sinus. The device has a distal end, a proximal end, and an intermediate portion, and the distal end and proximal end are posteriorly disposed when placed near the posterior leaflet of the mitral valve in the coronary sinus. A force is applied to the wall of the coronary sinus, and the intermediate portion applies an anterior force to the wall of the coronary sinus, thereby moving the posterior annulus forward to improve valvular junction.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising an elongated body that is generally straight near the posterior leaflet of the mitral valve in a patient's coronary sinus. The length of the substantially straight elongate body is relative to the original curve of the coronary sinus near the leaflet behind the mitral valve and the substantially straight elongate body is within the coronary sinus. When deployed, causes at least a portion of the coronary sinus to have a generally straight shape adjacent to the posterior leaflet of the mitral valve, thereby increasing the radius of curvature of the mitral annulus and The length is set to improve the joining.

  In another form of the invention, a method is provided for reducing mitral regurgitation, the method comprising an elongated body that is generally straight near the posterior leaflet of the mitral valve in a patient's coronary sinus. The length of the substantially straight elongate body is relative to the original curve of the coronary sinus near the leaflet behind the mitral valve and the substantially straight elongate body is within the coronary sinus. When deployed, causes at least a portion of the coronary sinus to assume a different shape adjacent to the posterior valve leaflet of the mitral valve, thereby moving the mitral annulus forward to improve valve joints It has been such a length.

  In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method being substantially straight and substantially near the posterior leaflet of the mitral valve in the patient's coronary sinus. The length of the straight, substantially robust elongated body is substantially straight relative to the original curve of the coronary sinus near the valvular posterior leaflet of the mitral valve When a substantially rigid elongated body is disposed within the coronary sinus, causing at least a portion of the coronary sinus to exhibit a generally straight shape adjacent to the posterior leaflet of the mitral valve, thereby The radius of curvature of the mitral annulus is increased to improve the valve joint.

  In another aspect of the present invention, an apparatus for reducing mitral regurgitation is provided, the apparatus having a body having a distal end, a proximal end, and an intermediate portion, wherein the monk in the coronary sinus. When positioned near the posterior leaflet of the cap valve, the distal and proximal ends exert a posterior force on the coronary sinus wall and the intermediate portion exerts an anterior force on the coronary sinus wall. , Thereby including a body configured to move the posterior annulus of the mitral valve forward to improve valve joints.

  In another aspect of the present invention, an apparatus for reducing mitral regurgitation is provided, the apparatus having a body having a distal end, a proximal end, and an intermediate portion, wherein the posterior valve leaflet of the mitral valve The distal and proximal ends exert a posterior force on the coronary sinus wall and the intermediate portion exerts an anterior force on the coronary sinus wall when placed in the coronary sinus near , Thereby including a body configured to move the posterior annulus of the mitral valve forward to improve valve joints.

  In another aspect of the present invention, an apparatus for reducing mitral regurgitation is provided that is inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve. A substantially straight elongate body made, the overall length of which is near the posterior leaflet of the mitral valve and the original curvature of the coronary sinus; Causing at least a portion of the coronary sinus to exhibit a substantially straight structure adjacent to the posterior leaflet of the mitral valve when placed in a sinus, thereby providing a radius of curvature of the mitral annulus And includes a substantially straight body that is long enough to move the annulus forward and thereby improve the valve joint.

  In another aspect of the present invention, an apparatus for reducing mitral regurgitation is provided that is inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve. A substantially rigid elongate body made, wherein the substantially rigid elongate body is disposed within the coronary sinus relative to the natural curvature of the coronary sinus near the posterior leaflet of the mitral valve When done, cause at least a portion of the coronary sinus to exhibit a different structure adjacent to the posterior leaflet of the mitral valve, thereby moving the posterior annulus forward and thereby improving valvular junction A substantially rigid elongate body that is structured to:

  In another aspect of the present invention, an apparatus for reducing mitral regurgitation is provided that is inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve. A substantially straight and substantially elongate body made, the length of which is substantially straight and substantially relative to the original curvature of the coronary sinus near the posterior leaflet of the mitral valve When a particularly rigid elongated body is disposed within the coronary sinus, at least a portion of the coronary sinus has a substantially straight structure adjacent to the posterior leaflet of the mitral valve; Includes a substantially straight body that is lengthened to increase the radius of curvature of the mitral annulus to move the annulus forward and thereby improve valve joints.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Straighten the original bend of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve into the coronary sinus near the posterior leaflet of the patient's mitral valve so that the posterior valve of the mitral valve Inserting a device adapted to move the annulus forward and thereby improve the connection of the annulus,
The device includes an elongate body having a curvature less than that of the coronary sinus in an unstressed state prior to insertion into the coronary sinus, the device between the device and the mitral valve Is more rigid than the anatomical tissue placed in, so that the placement of the device in the coronary sinus moves the posterior annulus of the mitral valve forward to improve valvular junction Yes.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Move the posterior annulus forward by moving at least a portion of the coronary sinus near the posterior leaflet of the mitral valve into the coronary sinus near the posterior leaflet of the patient's mitral valve to join the valve Consisting of inserting a device made to improve,
The device includes an elongate body having a shape that is straighter than the curvature of the coronary sinus in an unstressed state prior to insertion into the coronary sinus, the device between the device and the mitral valve It is more rigid than the anatomical tissue placed on it, thereby moving the posterior annulus of the mitral valve forward by placement of the device in the coronary sinus to improve valvular junction .

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Insert a device into the coronary sinus near the posterior valve leaflet of the patient's mitral valve to reduce the inherent curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve; By moving the posterior annulus of the mitral valve forward to improve valve joints,
The device includes an elongated body having a relatively straight shape in an unstressed state, the device being more rigid than the anatomical tissue disposed between the device and the mitral valve; Thus, the placement of the device within the coronary sinus moves the mitral valve posterior annulus forward to improve valvular junctions.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Insert a device into the coronary sinus near the posterior leaflet of the patient's mitral valve to increase the natural radius of the original curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve And thereby moving the rear annulus forward to improve the valve joint,
The device includes an elongated body having a relatively straight shape in an unstressed state, the device being more rigid than the anatomical tissue disposed between the device and the mitral valve; Thus, the placement of the device within the coronary sinus moves the mitral valve posterior annulus forward to improve valvular junctions.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Into the coronary sinus near the posterior leaflet of the patient's mitral valve, having a distal end, a proximal end, and an intermediate portion, when the device is placed in the coronary sinus proximate to the posterior leaflet of the mitral valve The distal and proximal ends exert a posterior force on the wall of the coronary sinus and the intermediate portion exerts an anterior force on the wall of the coronary sinus to move the posterior annulus forward, thereby causing the leaflet Consists of inserting a device that is shaped to improve
The device includes an elongated body having a relatively straight shape in an unstressed state, the device being more rigid than the anatomical tissue disposed between the device and the mitral valve; Thus, the placement of the device in the coronary sinus moves the posterior annulus forward to improve valve joints.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Inserting a generally straight body near the posterior leaflet of the mitral valve in the patient's coronary sinus, the total length of the straight elongate body being in the coronary sinus near the valve leaf behind the mitral valve With respect to the original curve, at least a portion of the coronary sinus exhibits a substantially straight shape adjacent to the posterior leaflet of the mitral valve when the substantially straight elongated body is disposed within the coronary sinus. , Thereby increasing the radius of curvature of the mitral annulus and improving the valve joint,
The generally straight elongated body includes a rod having a substantially straight shape in an unstressed state, the device being more rigid than the anatomical tissue disposed between the device and the mitral valve Yes, with the placement of the device in the coronary sinus, the posterior annulus is moved forward to improve valve joints.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Inserting a substantially rigid elongate body in the patient's coronary sinus near the posterior leaflet of the mitral valve, the substantially rigid elongate body comprising a coronary vein near the valve leaf behind the mitral valve When the generally rigid elongate body is positioned within the coronary sinus with respect to the original sinus curve, at least a portion of the coronary sinus assumes a different shape adjacent to the posterior leaflet of the mitral valve , Thereby moving the posterior annulus of the mitral valve forward, thereby improving the joint of the valve leaflets,
The substantially rigid elongated body includes a rod having a relatively straight shape in an unstressed state, the device being more than an anatomical tissue disposed between the device and the mitral valve It is rigid, so that the placement of the device within the coronary sinus moves the posterior annulus forward to improve valve joints.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
The insertion of a substantially straight and substantially rigid elongated body near the posterior leaflet of the mitral valve in the patient's coronary sinus, the total length of the straight and substantially rigid elongated body comprising the mitral valve At least a portion of the coronary sinus when the substantially straight and substantially rigid elongated body is positioned within the coronary sinus relative to the original curve of the coronary sinus near the posterior leaflet It is sized to exhibit a substantially straight shape adjacent to the posterior valve leaflet of the cap valve, thereby increasing the radius of curvature of the mitral annulus and improving the joint of the valve leaflet,
The substantially straight and substantially rigid elongated body includes a rod having a substantially straight shape in an unstressed state, the device comprising an anatomy disposed between the device and the mitral valve It is more rigid than the target tissue, so that the placement of the device in the coronary sinus moves the posterior annulus forward to improve valvular junction.

In another aspect of the invention, an apparatus for reducing mitral regurgitation is provided, the apparatus comprising:
A body having a distal end, a proximal end, and an intermediate portion, wherein the distal end and the proximal end are posterior to the wall of the coronary sinus when placed in the coronary sinus near the posterior leaflet of the mitral valve And the intermediate portion applies a forward force to the wall of the coronary sinus, thereby moving the posterior annulus of the mitral valve forward to improve the valve joint Including
The body includes a rod that has a relatively straight shape in an unstressed state, and the device is more robust than the anatomical tissue disposed between the device and the mitral valve. Yes, by placing the device in the coronary sinus, the posterior annulus is moved forward to improve valvular junctions.

In another aspect of the invention, an apparatus for reducing mitral regurgitation is provided, the apparatus comprising:
A substantially straight elongate body adapted to be inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve, the full length of the coronary being near the posterior leaflet of the mitral valve With respect to the original curvature of the sinus, at least a portion of the coronary sinus is substantially adjacent to the posterior leaflet of the mitral valve when the substantially straight elongated body is disposed within the coronary sinus. A substantially straight structure, thereby increasing the radius of curvature of the mitral annulus to move the annulus forward and thereby improve the joint of the valve leaflets. Including the body,
The body includes a rod having a substantially straight shape in an unstressed state, the device being more robust than the anatomical tissue disposed between the device and the mitral valve Thereby, the placement of the device in the coronary sinus moves the posterior annulus forward to improve valve joints.

In another aspect of the invention, an apparatus for reducing mitral regurgitation is provided, the apparatus comprising:
A substantially rigid elongated body adapted to be inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve, the original body of the coronary sinus near the posterior leaflet of the mitral valve Such that when the substantially rigid elongate body is positioned within the coronary sinus, at least a portion of the coronary sinus exhibits a different structure adjacent to the posterior leaflet of the mitral valve A substantially rigid elongate body configured to move the rear annulus forward and thereby improve the joint of the leaflet,
The body includes a rod having a substantially straight shape in an unstressed state, the device being more robust than the anatomical tissue disposed between the device and the mitral valve Thereby, the placement of the device in the coronary sinus moves the posterior annulus forward to improve valve joints.

In another aspect of the invention, an apparatus for reducing mitral regurgitation is provided, the apparatus comprising:
A substantially straight, substantially rigid, elongated body adapted to be inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve, the length of which is posterior to the mitral valve When the substantially straight and substantially rigid elongated body is disposed within the coronary sinus relative to the natural curvature of the coronary sinus near the leaflets, at least a portion of the coronary sinus is A substantially straight structure adjacent to the posterior valve leaflet of the mitral valve, thereby increasing the radius of curvature of the mitral valve annulus and moving the annulus forward, thereby improving valve joint bonding Including a substantially straight body that is of a length,
The body includes a rod having a substantially straight shape in an unstressed state, the device being more robust than the anatomical tissue disposed between the device and the mitral valve Thereby, the placement of the device in the coronary sinus moves the posterior annulus forward to improve valve joints.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the method comprising:
Reversing the original bend of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve into the coronary sinus near the posterior leaflet of the patient's mitral valve, thereby posterior annulus of the mitral valve Inserting a device designed to improve the joint of the annulus by moving the
The apparatus includes a rod and a stabilizing framework coupled to the rod.

In another aspect of the invention, a method is provided for reducing mitral regurgitation, the device comprising:
An elongated body adapted to be inserted into the coronary sinus near the posterior leaflet of the patient's mitral valve;
The device reverses the natural bend of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve, thereby moving the mitral annulus forward to improve mitral valve junctions, Includes a rod and a stabilizing framework coupled to the rod.

  Importantly, the present invention can be implemented in a minimally invasive or permanent manner to reduce mitral regurgitation.

DESCRIPTION OF PREFERRED EMBODIMENTS

  These and other objects and features of the invention will be more fully described or made apparent by the following detailed description of preferred embodiments of the invention considered in conjunction with the accompanying drawings. In the accompanying drawings, like reference numerals designate like elements.

  The coronary sinus is the largest vein in the human heart. In most of the pathways within the atrioventricular groove, the coronary sinus typically extends adjacent to the left atrium of the heart over a distance of about 5 to 10 centimeters. Importantly, for a portion of its length, for example typically 7-9 centimeters, the coronary sinus extends approximately adjacent to the posterior leaflet of the mitral valve. The present invention takes advantage of this fact. More specifically, by deploying the new device in the coronary sinus, the original bending of the coronary sinus adjacent to the mitral valve's posterior leaflet is deformed near the mitral valve's posterior leaflet. Thereby moving the posterior leaflet forward to improve valvular junction and, as a result, reduce mitral regurgitation.

  In one preferred embodiment of the present invention, the novel device is an elongated body having a generally straight shape, the entire length of which is located in the coronary sinus near the posterior leaflet of the mitral valve. When at least a portion of the coronary sinus assumes a straight shape adjacent to the posterior leaflet of the mitral valve, thereby moving the annulus of the mitral valve forward and thereby the leaflet It includes an almost straight body that is long enough to improve the joint.

  Further, in one preferred embodiment of the present invention, access to the coronary sinus is made percutaneously, for example, the elongate body is connected to the patient's vasculature via the jugular vein or via the left subclavian vein. It is inserted into the system and passed down through the superior vena cava, through the right atrium, then into the coronary sinus and deployed in the coronary sinus. Alternatively, the elongate body can be introduced into the coronary sinus via a small incision in the heart or into the patient's vasculature via some other incision.

  Further, in one preferred embodiment of the invention, the elongate body is passed (i) through a pre-positioned catheter and / or (ii) along the circumference of a pre-positioned guidewire. And / or (iii) is guided into place in the coronary sinus by passing it through the surgical site by passing it unguided (eg, on the end of an operable delivery instrument). The

  Once deployed, the new device may be permanently left in place (eg, for patients suffering from mitral regurgitation associated with a cardiac defect) or the new device may be It may be left in place only temporarily (eg, for patients suffering from mitral regurgitation associated with acute myocardial infarction).

  Visualization of this procedure can be obtained by fluoroscopy, echocardiography, intravascular ultrasound angioscope, real-time nuclear magnetic resonance imaging, and the like. The efficacy of this procedure can be measured by echocardiography, although other imaging physiotherapy may also be suitable.

  Referring to FIG. 1, the configuration of the patient's circulatory system 3 is shown. More specifically, the circulatory system 3 generally includes a heart 6, a superior vena cava 9, a right subclavian vein 12, a left subclavian vein 15, a jugular vein 18, and an inferior vena cava 21. It is out. The superior vena cava 9 and the inferior vena cava 21 communicate with the right atrium 24 of the heart. The coronary ostium 27 is connected to the coronary sinus 30. At the distal end 31 (FIG. 2) of the coronary sinus 30, the vasculature is connected to a vertically descending interventricular vein (“AIV”) 32 (see FIGS. 1 and 2). For the purposes of the present invention, the term “coronary sinus” is generally conveniently considered to mean the vasculature extending between the coronary ostium 27 and the AIV 32.

  As shown in FIG. 2, between the coronary ostium 27 and the AIV 32, the coronary sinus 30 extends substantially adjacent to the rear outer periphery of the annulus 33 of the mitral valve 36. The mitral valve 36 includes a posterior leaflet 39 and an anterior leaflet 42. When the mitral valve regurgitates, the posterior leaflet 39 and the anterior leaflet 42 cannot generally join properly during systole, thereby leaving an intervening space 45 that can cause unwanted regurgitation.

  With continued reference to FIG. 3, an apparatus 100 is shown that includes one preferred embodiment of the present invention. More specifically, the device 100 generally includes a guide wire 103, a delivery catheter 106, and a push rod 109.

  Guidewire 103 includes a flexible body 112 having a distal end 115 and a proximal end 118. The distal end 115 of the guidewire 103 is a spring tip that allows the distal end of the guidewire 103 to move around without damaging the vasculature while the guidewire 103 is passing through the patient's vasculature. 121 is included.

  Delivery catheter 106 includes a flexible body 124 having a distal end 127 and a proximal end 130 and is preferably fitted with an adjustable valve 133. A central lumen 136 extends from the distal end 127 to the proximal end 130. In some situations, it may be preferable to provide an anchoring mechanism within the vasculature for anchoring the distal end 127 of the delivery catheter 106. As a non-limiting example, the inflatable balloon 139 has an inflation lumen 142 between the balloon 139 and the inflation fitting 145 on the outer periphery of the flexible body 124 at a location immediately adjacent to the distal end 127. You may arrange | position in the state extended between.

  Push rod 109 includes a flexible body 148 having a distal end 151 and a proximal end 154. A substantially straight and substantially rigid elongated body 157, which may have a variety of different lengths, is formed on the flexible body 148 adjacent the distal end 151. A removable proximal reinforcement (or handle) 160 is disposed between the elongated body 157 and the proximal end 154 to provide manual gripping of the flexible body 148, for example for entry or withdrawal purposes. It may be easy.

The device 100 can be used as follows to reduce mitral regurgitation.
First, the distal end 115 of the guidewire 103 is passed down through the patient's jugular vein 18 (or left clavicular vein 15), down through the superior vena cava 9, and through the right atrium 24 of the heart. Then, it is advanced along the coronary sinus 30 (see FIG. 4). It can be seen that as the flexible guidewire 103 is passed down through the coronary sinus 30, the guidewire tends to exhibit the original curved shape of the coronary sinus due to its flexibility. The atraumatic spring tip 121 of the guide wire will help ensure minimal damage to the vasculature when the guide wire 103 is maneuvered into place.

  The distal end 127 of the delivery catheter 106 is then placed around the proximal end 118 of the guidewire 103 and advanced downward until the delivery catheter 106 is placed in the coronary sinus 30 (see FIG. 5). ). Similarly, when the flexible delivery catheter 106 is advanced down the coronary sinus, the delivery catheter 106 tends to exhibit the original curved shape of the coronary sinus due to the flexibility of the delivery catheter. You will understand that.

  Once the delivery catheter 106 is placed in the coronary sinus, the guidewire 103 is removed (see FIG. 6). Before or after the guidewire 103 is removed, the balloon 139 can be inflated to secure the distal end 127 of the delivery catheter 106 in place within the coronary sinus 30.

  The push rod 109 is then advanced downward within the central lumen 136 of the delivery catheter 106. As the push rod's generally straight and substantially rigid elongate body 157 is advanced downward within the central lumen 136 of the delivery catheter 106, the substantially straight and substantially rigid elongate body 157 becomes disengaged. Would be urged to assume a substantially straight shape where the substantially straight and substantially rigid elongated body 157 currently exists (FIG. 7). As push rod 109 is advanced down through delivery catheter 106, balloon 139 serves to hold distal end 127 of delivery catheter 106 in place within coronary sinus 30.

  The push rod 109 is positioned adjacent to the posterior annulus 33 of the mitral valve 36 with a generally straight and substantially rigid elongated body 157 utilizing a proximal handle 160 (FIG. 3) as required. Until it is pushed down in the delivery catheter 106 (see FIG. 7). When this action is made, the generally straight and substantially rigid elongated body 157 in the delivery catheter 106 causes the mitral valve to have at least a portion of the coronary sinus 30 assume a generally straight shape at this location. The 36 rear valve annulus 33 is pushed forward. This also moves the mitral valve posterior leaflet 39 forward also to improve mitral valve leaflet junction, thereby reducing (or completely eliminating) mitral valve regurgitation. In this regard, the posterior annulus is displaced forward so that the valvular engagement or valvular and annulus is to an anatomically possible extent (eg, where the valve is anchored by left ventricular deformation). Attempt to achieve or attempt to achieve engagement. Both of these types of engagements or targeted engagements are intended to be encompassed by terms such as “improved valve joint” and / or “enhanced valve joint”. In order to reduce (or completely eliminate) mitral valve 36 regurgitation using standard visualization means (eg, echocardiography and / or fluoroscopy), it is substantially straight and substantially free. The exact position of the rigid elongated body 157 is adjusted.

  In this regard, the elongated body 157 that is substantially straight and substantially rigid is preferably somewhat shorter than the length of the coronary sinus between the coronary ostium 27 and the AIV 32. However, in some circumstances, it may be desirable to dimension the generally straight and substantially rigid elongated body 157 to extend from the coronary sinus 30 to the right atrium 24.

  Furthermore, it should also be understood that this device provides some tactile feedback to the user during deployment. More specifically, a substantially straight and substantially rigid elongated body 157 will typically experience significant resistance as it is pushed from the right atrium 24 into the coronary sinus 30. The resistance will then typically drop as the body 157 is moved through the coronary sinus. Then, when the distal end 151 (FIG. 3) of the push rod 109 and / or the leading edge of the body 157 reaches the distal end 31 of the coronary sinus, the resistance will typically increase significantly again. In this way, there is some tactile “sweet spot” when the elongate body 157, which is substantially straight and substantially rigid, is placed in the coronary sinus between the coronary ostium 27 and the AIV 32. This tactile “sweet spot” can help the user in properly positioning the substantially straight and substantially rigid elongated body 157 within the coronary sinus.

  At this point in the procedure, the substantially straight and substantially rigid elongated body 157 is locked in place by, for example, closing the delivery valve adjustable valve 133 (FIG. 3) to decompress the balloon 139. can do.

  The device 100 (smaller because the guidewire 103 has already been removed) remains in this position until it is no longer needed. In some cases (eg, for patients suffering from mitral regurgitation associated with acute myocardial infarction), this may leave the device 100 in place for hours, days or weeks. Is meant to be. In other cases (eg, for a patient suffering from mitral regurgitation associated with a cardiac defect), the device 100 may be substantially permanent. When the device 100 is removed and when it is to be removed, the push rod 109 is removed from the delivery catheter 106 and then the delivery catheter 106 is withdrawn from the patient.

  Thus, in the present invention, it will be seen that the substantially straight and substantially rigid elongated body 157 is basically press fit into the normal curved portion of the posterior leaflet of the mitral valve. . By sizing the length of the substantially straight and substantially rigid elongated body 157 to the proper curvature of the patient's anatomy and the substantially straight and substantially rigid elongated body 157 Is positioned substantially within the coronary sinus of the patient so that at least a portion of the coronary sinus is substantially straight adjacent to the posterior leaflet 39 of the mitral valve 36 by a substantially straight and substantially rigid elongated body. Will be presented. This action then moves the mitral valve's posterior annulus forward to improve valvular junction and thereby reduce mitral regurgitation. Thus, the mitral valve annulus 33 was enlarged by inserting a generally straight and substantially rigid elongated body 157 into the coronary sinus 30 adjacent to the posterior leaflet 39 of the mitral valve 36. It is efficiently operated to exhibit a radius of curvature.

  As described above, the substantially straight and substantially rigid elongated body 157 is sized appropriately for the natural curvature of the patient's anatomy and the substantially straight and substantially rigid elongated body 157 is By properly positioning in the coronary sinus of the coronary sinus, the substantially straight and substantially rigid elongated body 157 has a substantially straight shape adjacent to the posterior leaflet 39 of the mitral valve 36 in at least a portion of the coronary sinus. , Thereby driving the mitral valve posterior annulus forward to improve valvular junction and reduce mitral regurgitation. For this purpose, a push rod 109 is provided as part of a kit with a plurality of different push rods 109 each having an elongated body 157 of a different size so that the physician can analyze the anatomy of a particular patient. Preferably, an elongated body 157 sized appropriately for the structure can be selected and deployed. Further, if it is discovered (eg, by echocardiography and / or fluoroscopy) that different sized elongated bodies 157 are required during deployment, the first push rod 109 may be replaced by a second push rod 109 having an elongated body 157 of the desired size.

  In one preferred form of the invention, the diagnostic push rod 109 is initially inserted into the coronary sinus for the purpose of initially determining the appropriate length of the elongated body 157 for a particular patient anatomy. Similarly, a series of different sized diagnostic push rods 109 are subsequently inserted into the patient's coronary sinus to determine the preferred size for the elongated body 157. Thereafter, an appropriately sized therapeutic pushrod 109 can be inserted into the coronary sinus to improve valvular junctions and reduce mitral regurgitation.

  Further, prior to inserting the diagnostic push rod 109 into the patient's coronary sinus, the physician may determine the size of the coronary sinus in order to determine the initial expected length for the elongated body 157 of the diagnostic push rod 109. A temporary assessment can be made. This may be due to fluoroscopy using a guidewire 103 having a radiopaque marker on its surface, by using a delivery catheter 106 having a radiopaque marker on its surface, or by radiopacity. This can be done by inserting another device (eg, a flexible member) having a sex marker on the surface into the coronary sinus or other methods that will be apparent to those skilled in the art. Using the radiopaque marker, the physician performs a tentative assessment of the size of the coronary sinus, thereby determining the initial expected length for the elongated body 157 of the diagnostic pushrod 109. The diagnostic push rod 109 is then replaced as necessary until the appropriate length of the elongated body 157 is determined, and the appropriately sized diagnostic push rod 109 is replaced by the therapeutic push rod 109. .

  By inserting a substantially straight and substantially rigid elongated body 157 into the coronary sinus adjacent to the mitral posterior leaflet, the patient's left ventricle is also remodeled to help alleviate congestive heart failure. I knew it was possible.

  In the present invention, the distal and proximal ends of the substantially straight and substantially rigid elongated body 157 are posterior forces on the wall of the coronary sinus 30 (eg, as indicated by arrow P in FIG. 7). While the substantially straight and substantially rigid elongated body 157 applies a forward force to the wall of the coronary sinus 30 (eg, as shown by arrow A in FIG. 7). It is important to describe it.

  In some cases, the proximal end 130 (FIG. 3) of the delivery catheter 106 is secured to the patient's skin using standard patient management methods such as adhesive tape, purse string sutures, skin staples, and the like. be able to. In other cases, the proximal end 130 of the delivery catheter 106 may include a seam cuff that allows the delivery catheter to be secured to the patient's tissue by stitching. See, for example, FIG. 8 where a seam cuff 166 is shown attached to the proximal end 130 of the delivery catheter 106. If desired, a member 169 is provided at the proximal end of the adjustable valve 133 so that the flexible push rod 109 can be quickly delivered to the catheter 106 without using the adjustable valve 133 (FIG. 3). May be sent. For example, the member 169 may include a clippable member for securing the flexible push rod 109 to the delivery catheter 106, which is then secured to the patient, for example by a seam cuff 166. Is done. If desired, the proximal end of the assembly may be implanted under the patient's skin, for example in the case of permanent implantation.

  As noted above, it is convenient to secure the distal end of the delivery catheter 106 in place in the coronary sinus before pushing the push rod 109 into the delivery catheter. Such a configuration would maintain the delivery catheter in place as the substantially straight and substantially rigid elongated body 157 rotates within the right atrium and enters the coronary sinus. In the absence of such a fixation member, the push rod can move the delivery catheter down in the inferior vena cava 21. More specifically, by securing the distal end of the delivery catheter 106 to the wall of the coronary sinus 30, the delivery catheter rotates the generally straight and substantially rigid elongated body 157 within the coronary sinus. When receiving an initial resistance to this, the inferior vena cava 21 can be stabilized against branching downward. The balloon 139 is one method for performing such fixation. However, other types of securing mechanisms, such as spring clips, ribs, etc., for securing the distal end 127 of the delivery catheter 106 in place within the coronary sinus 30 may be utilized.

  If desired, the distal end 151 of the push rod 109 may itself be provided with a distal anchor, such as the distal anchor 172 shown in FIG. Such a distal anchor on the push rod 109 can help hold the generally straight and substantially rigid elongated body 157 in place within the coronary sinus 30.

  It is also possible to prevent the delivery catheter 106 from branching into the inferior vena cava 21 without anchoring the distal end of the delivery catheter to the wall of the coronary sinus. More particularly, referring to FIG. 10, a support catheter 173 is shown that is made of a material that is more robust than the flexible body 124 of the delivery catheter 106. The support catheter 173 can be positioned at its distal end 174 within the coronary ostium 27 and then when its push rod 109 is advanced downward into the delivery catheter 106, its side wall 174A has its inferior vena cava 21. Can be supported, thereby preventing the delivery catheter 106 from branching down into the inferior vena cava 21. FIG. 10 also shows an introducer catheter 174B located at the entrance to the jugular vein 18.

  In the description of the device 100 described above, the push rod 109 is advanced into the surgical site via the delivery catheter 106 and maintained within the delivery catheter 106 while at the surgical site, and when the push rod 109 is removed. Then, the delivery catheter 106 is described as being removed. However, if desired, once the push rod 109 has been deployed at the surgical site, the delivery catheter 106 may then be removed, leaving only the push rod 109 at the surgical site (see, eg, FIG. 11).

  It is also possible for the push rod 109 to enter the surgical site directly without passing through the delivery catheter, in which case the interventional vessel until the push rod 109 is deployed in the coronary sinus 30. You can enter the structure by yourself.

  As described above, when the push rod 109 is advanced into the region adjacent to the mitral posterior annulus, the substantially straight and substantially rigid elongated body 157 deforms the original shape of the coronary sinus. And will have an almost straight shape. Although this effect induces the desired valve remodeling, it can also induce significant stress on the coronary sinus wall, particularly the distal and proximal ends of the elongated body 157, which is generally straight and substantially rigid. The distal and proximal stresses of the elongated body 157 will be concentrated (see arrow P in FIG. 7). For this purpose, the structure of the substantially straight and substantially rigid elongated body 157 may be modified somewhat to better distribute this stress.

  More particularly, referring now to FIG. 12, the distal and proximal ends of the generally straight and substantially rigid elongated body 157 are compared to help better distribute the stress on the coronary sinus wall. A flexible portion 175 may be included. Additionally and / or alternatively, the taper applied to the distal and proximal ends of the substantially straight and substantially rigid elongated body 157 may be used to better distribute stress on the coronary sinus wall. For example, it may be longer as indicated by reference numeral 178 in FIG. In one preferred form of the invention, referring to FIG. 14, a substantially straight and substantially rigid elongated body 157 has a relatively long and relatively flexible portion 175 with a relatively long taper 178. You may have. If desired, each of the relatively long and relatively flexible portions 175 with a relatively long taper 178 may be the same length or longer than the generally straight and substantially rigid intermediate portion of the elongated body 157. good.

  Referring now to FIG. 15, there is shown an apparatus 181 that includes another preferred embodiment of the present invention. Device 181 more particularly includes guide wire 103, generally straight and substantially rigid elongated body 184 and push cannula 187.

  The guide wire 103 is as already described. A generally straight and substantially rigid elongated body 184 is provided in a variety of different lengths and includes a distal end 188 and a proximal end 190. A central lumen 193 extends between the distal end 188 and the proximal end 190. The central lumen 193 accommodates the guide wire 103.

  The push cannula 187 includes a distal end 194 and a proximal end 196. A central lumen 199 extends between the distal end 194 and the proximal end 196. Central lumen 199 houses guidewire 103.

Device 181 can be used as follows to reduce mitral regurgitation.
First, the distal end 115 of the guidewire 103 is advanced downward in the patient's jugular vein 18 (or left subclavian vein 15), advanced downward in the superior vena cava 9, and in the right atrium 24 of the heart. And is passed along the coronary sinus 30. When the flexible guidewire 103 is passed down through the coronary sinus 30, the guidewire will tend to assume the original curved shape of the coronary sinus due to its flexibility. Will be understood. The guide wire's atraumatic spring tip 121 will help minimize damage to the vasculature when the guide wire is advanced into position.

  Next, the distal end 188 of the generally straight and substantially rigid elongated body 184 is placed around the proximal end 118 of the guidewire 103 and advanced downward by a distance from the guidewire. The distal end 194 of the pusher cannula 187 is then placed around the proximal end 118 of the guidewire 103 and then the pusher cannula 187 is advanced downward from the guidewire. As the push cannula 187 is advanced downward from the guide wire, its distal end 194 pushes the substantially straight and substantially rigid elongated body 184 in its direction of travel (see FIG. 16).

  When the generally straight and substantially rigid elongated body 184 is advanced downward in the coronary sinus, the coronary sinus is biased to a location where the substantially straight and substantially rigid elongated body 184 currently exists. It is made to take an almost straight shape. The push cannula is pushed down along the guide wire as needed until a generally straight and substantially rigid elongated body 184 is positioned adjacent the posterior annulus of the mitral valve. When this happens, the presence of the generally straight and substantially rigid elongated body 184 within the coronary sinus causes the coronary sinus to assume a substantially straight shape at this location, and As a result, the posterior annulus of the mitral valve is biased forward. This causes the posterior leaflet to also be moved forward to improve valvular junction, thereby reducing (or completely eliminating) mitral regurgitation. Use standard visualization means (eg, echocardiography and / or fluoroscopy) to reduce (or eliminate) mitral regurgitation almost straight and substantially robust The exact position of the elongated body is adjusted.

  If desired, the pusher cannula 187 can be releasably attached to the pusher cannula 187 such that the cannula can releasably secure the proximal end 190 of the generally straight and substantially rigid elongated body 184 (eg, a handle ) May be provided. Such a feature would allow a substantially straight and substantially rigid elongated body to be pulled posteriorly within the coronary sinus for positioning or removal.

  Thus, in the present invention, a substantially straight and substantially rigid elongated body 184 is fitted into the normally curved portion of the coronary sinus essentially adjacent to the posterior leaflet of the mitral valve. By properly sizing the length of the substantially straight and substantially rigid elongated body 184 and by properly positioning the substantially straight and substantially rigid elongated body 184 within the patient's coronary sinus, The elongate body 184 that is substantially straight and substantially rigid will cause at least a portion of the coronary sinus to assume a substantially straight shape adjacent to the posterior leaflet 39 of the mitral valve 36. This action then drives the mitral valve's posterior annulus forward to improve valvular junction and thereby reduce mitral valve regurgitation, thus a substantially straight and substantially robust elongated body By inserting 184 into the coronary sinus 30 adjacent to the posterior leaflet of the mitral valve 36, the mitral valve annulus 33 is efficiently manipulated to exhibit a large radius of curvature.

  As described above, the length of the substantially straight and substantially robust elongated body 184 is sized appropriately for the natural curvature of the patient's anatomy and the substantially straight and substantially rigid elongated body. By properly positioning the 184 in the patient's coronary sinus, the elongate body 184 is substantially straight and substantially robust so that at least a portion of the coronary sinus is substantially straight adjacent the posterior leaflet 39 of the mitral valve 36. Shape, thereby moving the mitral valve's posterior annulus forward to improve valvular junction and thereby reduce mitral regurgitation. For this purpose, the generally straight and substantially rigid elongated body 184 is a portion of a kit having a plurality of different generally straight and substantially rigid elongated bodies 184 each having a differently sized elongated body 184. Preferably, this allows the physician to select and deploy an elongated body 184 of an appropriate size for a particular patient anatomy. Further, if it is discovered (eg, by echocardiography and / or fluoroscopy) that a different sized elongated body 184 is required at the time of deployment, the first elongated body 184 is May be replaced by a second elongate body 184 having the size required to obtain the desired therapeutic result.

  In one preferred form of the invention, a diagnostic elongate body 184 is first placed within the patient's coronary sinus for the purpose of initially determining the appropriate length of the elongate body 184 for a particular patient anatomy. Is inserted. As before, a series of different sized diagnostic elongate bodies are inserted into the coronary sinus of the patient to determine the preferred size of the therapeutic elongate body 184. Thereafter, an appropriately sized therapeutic elongated body 184 is inserted into the coronary sinus to improve valvular junction, thereby reducing mitral regurgitation.

  Further, prior to inserting the diagnostic elongate body 184 into the patient's coronary sinus, the physician may determine the initial expected length for the diagnostic elongate body 184 to determine the coronary sinus size. An initial assessment may be made. This can be done by fluoroscopy using a guidewire 103 with a radiopaque marker on its surface or another device (eg, a flexible member) with a radiopaque marker on its surface in the coronary sinus. It can be done by insertion or in other ways apparent to those skilled in the art. When using radiopaque labels, the physician makes an initial assessment of the size of the coronary sinus, thereby determining the initial expected length of the diagnostic elongate body 184, and then The diagnostic elongate body 184 is changed as needed until the appropriate length of the diagnostic elongate body 184 is determined, and once the appropriate length of the diagnostic elongate body 184 is determined, This appropriately sized diagnostic elongate body 184 is replaced with a therapeutic elongate body 184.

  As also noted above, when the generally straight and substantially rigid elongated body 184 is advanced to a region adjacent to the mitral posterior annulus, the generally straight and substantially rigid elongated body 184 is coronal. The original shape of the sinus sinus will be deformed to assume a nearly straight shape. Although this effect causes the desired valve remodeling, it can cause significant stress on the wall of the coronary sinus at the distal and proximal ends of the substantially straight and substantially rigid elongated body 184, particularly where stress is concentrated ( (See, for example, arrow P in FIG. 7). For this purpose, the shape of the elongated body 184, which is substantially straight and substantially robust, may be modified somewhat to better distribute this stress.

  More specifically, referring now to FIG. 17, the distal and proximal ends of the generally straight and substantially rigid elongated body 184 are provided to help better distribute the stress on the coronary sinus wall. Relatively flexible portions 188A, 190A may be included. Additionally and / or alternatively, a taper applied to the distal and proximal ends of the substantially straight and substantially rigid elongated body 184 may be used to better distribute the stress applied to the coronary sinus wall, e.g. 18 may be elongated as indicated by 188B and 190B. In one preferred form of the invention, referring to FIG. 19, a substantially straight and substantially rigid elongated body 184 is a relatively long and relatively flexible body with relatively elongated tapered portions 188B, 190B. Portions 188A and 190A may be provided. If desired, each of this relatively long and relatively flexible portion 188A, 190A with a relatively long taper 188B, 190B is the same as the substantially straight and substantially rigid intermediate portion of the elongated body 184. It can be long or longer. In the previous description, the elongate body 157 (or 184) has a relatively flexible portion 175 (FIG. 12) (or 188A, 190A, FIG. 17) and / or a tapered portion 178 (FIG. 13) (or 188B, 190B, FIG. 18) and / or substantially straight and substantially robust with or without an elongated, relatively flexible taper (FIG. 14) (188A, 188B, 190A, 190B, FIG. 19) As generally described. However, terms such as “substantially straight”, “substantially robust” and “relatively flexible” are to be interpreted in the context of anatomy and are interpreted in an absolute sense. It should be understood that it should not.

  Basically, the elongate body 157 (or 184) (1) applies an anterior force to the wall of the coronary sinus (1) as its middle portion (eg, as indicated by arrow A in FIG. 7) 2) The distal end and the proximal end are configured to apply a posterior force to the wall of the coronary sinus (eg, as indicated by arrow P in FIG. 7). Conversely, a large central load L1 (FIG. 20) is applied to the middle portion of the elongated body 157 (or 184) by the mitral valve annulus and a smaller end load L2 (FIG. 20) is applied to the posterior portion of the coronary sinus. To the distal and proximal ends of the elongated body 157 (or 184).

  In particular, such action is (1) straighter than the original curvature of the portion of the coronary sinus adjacent to the posterior leaflet of the mitral annulus (but need not be completely straight), Formed by using an elongated body 157 (or 184) that is more robust (but not necessarily completely robust) than the anatomy to be displaced by the deployed elongated body 157 (or 184) can do.

  As noted above, the distal and proximal ends of the elongated body 157 (or 184) are relatively flexible portions 175 (FIG. 12) to better distribute the load on the proximal portion of the coronary sinus. (Or 188A, 190A, FIG. 17) and / or a tapered portion 178 (FIG. 13) (or 188B, 190B, FIG. 18) and / or an elongated, relatively flexible tapered portion 175, 178 (FIG. 14) (188A) , 188B, 190A, 190B, FIG. 19). Further, the flexibility of these portions 175 (188A, 190A), 178 (188B, 190B) and / or 175,178 (188A, 188B, 190A, 190B) can vary along their length. Thus, this elongated, relatively flexible taper 175, 178 (FIG. 14) (188A, 188B, 190A, 190B, FIG. 19) becomes more flexible when they extend toward their outer ends. obtain.

  In fact, there is nothing in the present invention that requires the middle portion of the elongated body 157 (or 184) to be absolutely robust, in fact, the larger intermediate load imposed by the mitral valve It will function satisfactorily as long as it substantially withstands L1 (FIG. 20). This design is further enhanced by making the distal and proximal ends of the elongated body 157 (or 184) somewhat less resistant to smaller end loads L2 (FIG. 20) guided by the posterior wall of the coronary sinus. In this way, the flexibility gradient along the length (or the center or near the center is the highest and the two ends or near the two ends less rigid) (or Conversely, the flexibility at the center or near the center is the least flexible along the length of the two ends or more flexible near the two ends. A satisfactory design can be imparted by a device having a robust gradient along its length. This can be accomplished by providing a taper on the elongated body and / or by changing its composition and / or material properties and / or by other techniques that will be apparent to those skilled in the art of the present invention. Alternatively, a satisfactory design can be imparted by a device having some flexibility along its entire length, which flexibility can vary depending on the length or the elongated body 157 (or 184). ) May be substantially constant along the entire length.

  Thus, as noted above, a satisfactory design is (1) straighter than the body bend of the coronary sinus portion adjacent to the posterior leaflet of the mitral valve annulus (but not necessarily fully (2) is more robust (but not necessarily completely robust) than the anatomy that is to be displaced by the deployed elongated body 157 (or 184) ) Can be performed by the elongated body 157 (or 184). In other alternative embodiments, the elongate body 157, 184 may be formed by two or more substantially straight and substantially rigid sections R joined together by one or more flexible sections F. good. See, for example, FIGS. 21 and 22 showing such a structure. By changing the relative lengths of sections R and F and by changing the relative flexibility of flexible section F, it provides superior annulus displacement, thereby improving mitral regurgitation Can be reduced to

FIGS. 23 and 24 show that a substantially straight and substantially rigid elongated body 157, 184 includes a plurality of sections S ₁ , S ₂ , S ₃ , which section S ₁ has a selected degree of flexibility. The section S ₂ has a lower flexibility than the section S ₁ , and the section S ₃ has a higher flexibility than the section S _1. Yes. The sections S ₁ , S ₂ , S ₃ may be formed integrally with each other or connected to each other by a joint. As a result of this construction, section S ₁ will carry a load to reconstruct the mitral valve annulus, and section S ₂ will transmit this load to section S ₃ away from the center and section S 1 ₃ will distribute the load to the side wall of the coronary sinus. In one preferred form of the invention, segment S ₁ has some degree of flexibility to assist in the remodeling of the mitral valve annulus, while segment S ₁ is curved in the mitral valve annulus at this location. The section S ₂ is flexible so that almost all of the load generated by the remodeling of the mitral valve annulus is transmitted to the section S ₃ . The section S ₂ is structured so that the degree of sex is sufficiently low, so that the posterior force against the wall of the coronary sinus (eg as indicated by arrow P in FIG. 7) is It has a sufficient length to be applied substantially to the proximal and distal ends of the transverse association. In this form, the pure straightening action is the outward pressure that tensions the continuous fibers at the base of the heart rather than between the transverse associations where such forces may tend to cause reflux. multiply. In particular, such a structure has been molded to naturally conform to the curvature of the posterior leaflet. If desired, such a “five-region” elongate body can be formed from a single material having various diameters used to form various body regions.

  Thus, in various alternative embodiments, the elongate body 157 and / or 184 may be flexible along at least a portion of its length. Local flexibility and local robustness can allow selected positions of the coronary sinus and corresponding positions of the posterior annulus to be straightened. This can move the annulus area of the mitral valve forward, resulting in a local improvement in valvular junction. Further, the elongated body may be formed by two sections joined together by fibrils, by securing the two end sections to the anatomy and pulling the taught fibrils. The original bend of the coronary sinus can be straightened to move the mitral valve annulus anterior, thereby reducing mitral regurgitation.

  Altering the robustness of the elongated bodies 157, 184 can result in anatomical deformations over a range of mitral valves. More specifically, FIG. 25 shows a normal mitral valve with valve membranes 39, 42 properly joined, and FIG. 26 shows a reversing mitral valve with valve membranes 39, 42 not properly joined. 36 is shown.

  The central portion of the elongated body 157, 184 is large and substantially completely robust compared to the anatomy, and the two ends of the elongated body 157, 184 are relatively flexible portions (eg, this Such a structure ends in FIGS. 14 and 19), and the anatomical deformation can be substantially similar to that shown in FIGS. 27 and 28.

  The elongated books 157 and 184 have some flexibility in both the central part S1 and the two ends S3 and in the coupling part S2 (eg such a structure is shown in FIGS. 23 and 24). In the case of having a rod with a relatively inflexible portion, this elongated body supports the annulus and contacts the wall of the coronary sinus such as that shown in FIGS. It can be made to provide a flexible strap for loose engagement. In one preferred form of the invention, the elongate bodies 157, 184 have a flexibility formed along their length to closely match the original annulus geometry, The rear valve annulus (and the rear valve membrane) is moved toward the front valve membrane while the rear valve annulus is supported in the original bent state as shown in FIGS. 31 and 32.

  In one preferred construction, the elongate bodies 157, 184 provide a posterior force (eg, as indicated by arrow P in FIG. 7) against the coronary sinus wall, primarily in the anterior and posterior lateral associations. It has a geometric structure and flexibility designed to be applied to the proximal and distal positions, respectively. For example, reference should be made to FIGS. 30 and 32, which show that the illustrated structure is forward (as indicated by arrow A) to the patient's anatomy or coronary sinus wall. Figure 6 shows a configuration in which force is applied to the distal and proximal ends (as indicated by arrows P) to the intermediate portion and the wall of the coronary sinus to apply the force. By applying a backward force P to the lateral union region of the valve, the lateral meander of the lateral union region is minimized and an excellent valve joint is obtained.

  In addition to the above, it will be appreciated that the amount of force applied to the annulus of the mitral valve will be a function of the size and geometry of the elongated body 157, 184 and its flexibility. Let's go. In one preferred form of the invention, the size, geometry and elasticity of the elongate body 157 is a relatively large force (eg, a force of about 0.91 to 2.2 kilograms (about 2 to 5 pounds)). Is preferably applied to the central portion of the mitral valve so that almost complete remodeling is typically accomplished as soon as the elongated body 157,184 is inserted into the coronary sinus. In another preferred form of the invention, the size, geometry, and elasticity of the elongated body 157, 184 is significantly less force (e.g., about 0.45-1.36 kilograms (about 1-3 pounds)). It is preferably applied to the annulus of the mitral valve so that only partial remodeling is typically achieved as soon as the elongated body 157,184 is inserted into the coronary sinus. However, by making the elongate body 157, 184 from a sufficiently elastic or preferably superelastic material such as Nitinol, the elongate body can subsequently be moved even if the anatomy begins to move in response to the applied load. The force to remodel the mitral valve will continue to be applied, and in this way, the desired complete remodeling will gradually occur.

  In the latter case where the elongate bodies 157, 184 are made of an elastic material so that the desired valve modifications are always produced gradually, the force applied by the elongate bodies 157, 184 is always relatively constant. Often it is desirable to remain. For this purpose, certain materials may be desirable over others. More specifically, referring now to FIG. 33, there is shown a diagram illustrating force versus deformation curves for two materials such as Nitinol and Stainless Steel. As can be seen in FIG. 33, since nitinol is deformed during initial implantation and then relaxed during subsequent tissue remodeling, this applies a relatively constant force to the tissue. However, as stainless steel is deformed and then relaxed, this applies a wide range of forces to the tissue. It is generally desirable that the elongated bodies 157, 184 be made at least in part from nitinol or other superelastic material.

  In addition to the above, the elongated body 157 and / or 184 may have any of a variety of non-linear shapes along its length. For example, the elongate body may be wavy, helical or curved along all or part of its length. By way of example, the elongate body 157 and / or 184 has a curved shape to reverse the natural curvature of the coronary sinus, i.e., the elongate body is bent toward the anterior valve annulus. Also good. Alternatively, the elongate body may have a composite shape along its length, for example, it may have a “w” shape type with the center facing the front annulus. Any of these or other alternative shapes can result in a forward displacement of the posterior annulus that results in reduced mitral valve regurgitation.

  34-36, it will be appreciated that the elongated body 157 and / or 184 may be provided with a coronal rib 200 extending radially outward from the bodies 157, 184 (FIG. 34). And 35). These ribs 200 engage the wall of the delivery catheter 106, i.e., where the delivery catheter 106 is not in use or where the delivery catheter 106 has already been removed, the wall of the coronary sinus 30 is The movement of the main bodies 157 and 184 is reduced. The rib 200 is also formed by an annular groove 202 (FIG. 36) in the main bodies 157, 184, in which case the outer peripheral surface 204 of the rib 200 coincides with the outer peripheral surface 205 of the main body. The rib 200 may be provided with a substantially flat outer peripheral edge 206 (FIGS. 34 and 36) or a substantially frustoconical outer peripheral edge 207 (FIG. 35). In the latter case, the inclined surfaces 208 of some edges 207 of the ribs 200 are preferably oriented in the proximal direction, while the inclined surfaces 208 of the remaining ribs are preferably oriented in the distal direction ( FIG. 35). The elongated body 157, 184 may be a flexible portion 175 (FIG. 12) (or 188A, 190A, FIG. 17) and / or a tapered portion 178 (FIG. 13) (or 188B, 190B, FIG. 18) and / or an elongated comparison. Ribs 200 are similarly formed on these structures if they include statically flexible tapered portions 175, 178 (FIG. 14) (or 188A, 188B, 190A, 190B, FIG. 19). May be.

  FIG. 37 shows an alternative embodiment in which the stabilizing framework 210 is used in combination with the elongated bodies 157, 184 shown in FIG. In this embodiment, the stabilizing skeleton 210 includes a generally cylindrical circle disposed within the coronary sinus and is secured to the wall of the coronary sinus, after which the elongated bodies 157, 184 ( The rib 200 is provided on the surface), and is disposed in the stabilizing skeleton 210. The ribs 200 of the elongate bodies 157, 184 are adapted to engage several portions of the stabilization skeleton 210 so that the elongate bodies are secured in place within the coronary sinus 30. For example, if the stabilization skeleton 210 includes openings between the frames of its skeleton, the ribs 200 may be used to help lock the elongated body 157,184 to the stabilization skeleton 210. Can interact with materials and openings.

  More specifically, in this form of the invention, the stabilizing scaffold 210 is (eg, an outward extension and / or a spine carried by and / or by the scaffold into the stabilizing scaffold). Etc.) fixed to the wall of the coronary sinus, and the elongated body 157, 184 (with the rib 200 on the surface) is fixed to the stabilizing skeleton 210 (eg by engagement of the rib and skeleton) , Thereby providing (1) a sustainable reduction in mitral regurgitation and / or (2) a larger load L1 (helping to secure the elongate body 157, 184 from entering longitudinally 20) helps to support the coronary sinus 30 when applied over the coronary sinus and / or (3) the concentrated end load L2 (FIG. 20) of the elongate body 157, 184 is more than that of the coronary sinus. To help minimize the trauma to the host vessel and / or (4) limit the morphological changes in the cross-section of the vessel in response to a load applied inside the vessel Helps ensure high blood flow and minimize vascular trauma. In this regard, the coronary sinus generally has various properties along its length (eg, diameter, wall robustness, etc.), and the stabilizing skeleton 210 correspondingly has its own length. Can be made to exhibit different characteristics. As a non-limiting example, the stabilizing skeleton 210 can have a smaller diameter at its distal end and a larger diameter at its proximal end to accommodate the typical geometric structure of the coronary sinus. As yet another non-limiting example, the stabilizing skeleton 210 provides greater support at the proximal end of the coronary sinus (often the veins are often relatively soft) and (often the veins are often relatively stiff). It may be made to provide less support at the end of the coronary sinus.

  In one form of the invention where the elongate body 157 is positioned inside the stabilizing skeleton 210 in the coronary sinus 30, the guidewire 103 is first advanced into the coronary sinus as described above. A skeletal deployment catheter 212 (FIG. 38) having a stabilizing skeleton 210 therein is advanced along the guidewire 103 into the coronary sinus. When the stabilizing skeleton 210 is placed at a desired location within the coronary sinus, the interference member 214 resting on the guidewire 103 is engaged with the stabilizing skeleton and the skeletal deployment catheter 212 is Pulled back sufficiently to deploy 210 and then withdrawn along the cushioning member 214 leaving the stabilizing framework 210 and guidewire 103 in place within the coronary sinus 30. The delivery catheter 106 is then advanced along the guidewire 103 until the distal end of the delivery catheter is positioned within the stabilizing skeleton within the coronary sinus. Once the delivery catheter 106 is positioned within the stabilizing skeleton within the coronary sinus, the guidewire 103 is withdrawn. The push rod 109 is then advanced through the central lumen 136 of the delivery catheter 106 until the elongated body 157 is positioned within the stabilizing skeleton 210 adjacent the posterior annulus of the mitral valve 36. The delivery catheter 106 is then withdrawn, at which time the body rib 200 engages the stabilizing skeleton as described above and pushes the push rod 109 with the elongated body 157 locked into the stabilizing skeleton 210. Leave in place.

  In another form of body where the elongate body 184 is placed inside the stabilizing skeleton 210 within the coronary sinus, the guidewire 103 placed inside the skeleton 210 is, as described above, the coronary vein. You can enter the cave. A skeletal placement catheter 212 with a stabilizing skeleton 210 is mounted on the guidewire 103 and advanced into the coronary sinus 30. The skeletal deployment catheter 212 is then pulled rearward enough to deploy the stabilizing skeleton 210 with the cushioning member 214 holding the stabilizing skeleton 210 in place, and then along the cushioning member 214. The guide wire 103 and the stabilizing skeleton 210 are left in place. The body 184 and pusher cannula 187 are then advanced along the periphery of the guidewire 103 until the elongate body 184 is positioned within the stabilization skeleton 210. The push cannula 187 and guide wire 103 are then withdrawn, leaving the elongated body 184 and the stabilizing skeleton 210 in place with the elongated body 184 locked within the stabilizing skeleton.

  Referring to FIG. 39, there is the largest load (L1) on the stabilizing skeleton 210, and the elongated body 157, 184 is in the middle part and either toward the distal end or the proximal direction of the stabilizing skeleton, thus the body 157,184. You can see that the movement of is reduced.

  40 and 41, it will also be appreciated that the elongated bodies 157, 184 can have a diameter that is substantially smaller than the diameter of the stabilizing framework 210. In this case, the stabilizing skeleton 210 can be provided with a guide 211 for receiving the elongated bodies 157, 184. As an example, the guide 211 may include a hollow tube formed on the inner wall of the stabilization skeleton 210, which can accommodate the elongated bodies 157, 184 and is fixed relative to the stabilization skeleton 210. The size is such that If desired, the stabilizing skeleton 210 may terminate at a location remote from the ends of the elongated bodies 157, 184, for example as shown in FIGS. Alternatively, the stabilization skeleton 210 may terminate together at the ends of the elongated bodies 157, 184, for example, in the manner shown in FIGS. 42 and 43, or the stabilization skeleton 210 may be, for example, It may extend beyond the ends of the elongated bodies 157, 184 in the manner shown in FIGS.

  In one preferred method for using the stabilizing skeleton 210210 and the elongated body 157, 184 of FIGS. 40, 41 or 42, 43 or 44, 45, the stabilizing skeleton 210210 is initially loaded with the guidewire 103. For example, a skeletal deployment catheter 212 similar to that shown in FIG. 38 except that it has been modified to be centered to pass through the guide 211 of the stabilizing skeleton 210 in the manner shown in FIG. And can be deployed using cushioning member 214. The stabilization skeleton 210210 is initially deployed in the manner described above, and the guidewire 103 is used to load the elongate body 157, 184 at a location within the coronary sinus including within the guide 211 of the stabilization skeleton 210. The

  In another configuration, referring to FIG. 47, the elongate bodies 157, 184 are preloaded into the stabilizing skeleton guide 211 when the stabilizing skeleton is loaded into the skeletal deployment catheter 212. In this configuration, the stabilizing framework 210210 and the elongate body 157, 184 are simultaneously deployed in the coronary sinus.

  As shown in FIG. 48, the body 157, 184 may be formed as part of the stabilizing skeleton 210, the combined stabilizing skeleton portion of the coronary sinus positioned for treatment. It is arranged in the middle part of the main bodies 157 and 184 to which the largest load L1 that is the load of the venous sinus is applied. Similarly, the stabilizing skeleton 210 may terminate away from the ends of the elongated bodies 157, 184 (FIG. 48), or the stabilizing skeleton 210 may terminate together at the ends of the elongated bodies 157, 184. Alternatively, the stabilizing framework 210 may extend beyond the ends of the elongated bodies 157, 184 (FIG. 50).

  In another embodiment shown in FIGS. 51 and 42, the combination of elongated body 157, 184 and stabilizing skeleton 210 includes two or more skeleton parts, such as parts 210A and 210B. , Portion 210A is located in the middle portion of this combination, and portion 210B extends within portion 210A and extends therefrom to form an end portion having greater elasticity. Is forming. The main bodies 157 and 184 are fixed to a generally cylindrical skeleton portion 210A and a cylindrical skeleton portion 210B disposed in the middle part of the main bodies 157 and 184. The middle part 210A, which is the strongest part of the combination of the elongated body and the stabilizing skeleton, is the part that can withstand the largest load L1.

  53 and 54 show an alternative embodiment in which the elongated bodies 157, 184 are secured to a series of ribs 215 in two rows. As can be seen in FIG. 54, the lines of ribs 215 are relatively offset so that the ribs on one side of the elongated body 157, 184 do not face the ribs on the opposite side of the elongated body. It is preferable. This causes the rib 215 to deflect toward the opposite side without engaging the opposite rib. The deflection of these ribs is compressed so that the ribs are placed in the catheter.

  FIG. 55 shows an alternative structure similar to that of FIG. 54 but showing ribs 215 coupled to the spine 216, the spine 216 containing elongated bodies 157, 184 therein. The cannula has been inserted.

  In FIG. 56, an alternative combination of an elongated body and a skeleton assembly is shown, wherein the stabilizing skeleton 210210 includes elongated body portions 157, 184 in the form of rods integrated with the skeleton. In the embodiment shown in FIG. 56, at least one body portion 157, 184 extends from one end of the assembly to the other end, while the other body portion 157, 184 extends from the assembly. It extends only in the middle part. Thus, the end of the assembly is less robust than its middle portion.

  Referring to FIG. 57, the main body 157, 184 includes an intermediate portion including all three stabilizing skeletons 210 ′, 210 ″ and 210 ′ ″, and a portion away from the center of the intermediate portion is the stabilizing skeleton 210 ″, 210. It may also contain only stabilizing skeletons, for example stabilizing skeletons 210 ′, 210 ″ and 210 ′ ″, including “” while the ends contain only one stabilizing skeleton 210 ′ ″. The middle portion of the body 157, 184 is most resistant to movement, while the end has the least resistance, and the region in the stabilizing skeleton 210 "is smaller than the middle portion but greater than the end. Is granted.

Referring now to FIGS. 58-60, an alternative combination of an elongate body and a skeleton assembly is shown in which the elongate body includes five of the types shown in FIGS. Includes an elongate body 157,184 comprised of regions, the skeleton including three support skeletons, ie, each of the types shown in FIGS. 40-47 to accommodate the elongate bodies 157,184. The guide 211 is provided. More particularly, the five-region elongated body 157, 184 includes a plurality of sections S ₁ , S ₂ and S ₃ , with the section S ₁ having a selected degree of flexibility. S ₂ is a structure having a lower degree of flexibility than section S ₁ , and section S ₃ is a structure having a higher degree of flexibility than section S ₁ . As a result of this construction, division S ₁ is to carry the load to reshape the annulus of the mitral valve, division S ₂ will transmit the load away from the far center segment S _3, a partitioned S ₃ coronal The load away from the center of the sinus sidewall will be distributed. In a preferred form of the invention, the segment S ₁ has a degree of flexibility to assist in the remodeling of the mitral valve annulus, but the curved arc of the mitral valve annulus where the segment S ₁ is still engaged. The section S ₂ is sufficiently flexible so that almost all of the load generated by the remodeling of the mitral valve annulus is transmitted to the section S _3. The section S ₂ is, for example, a posterior force on the wall of the coronary sinus (as indicated by the arrow F in FIG. 7) of the lateral association of the valve. It is long enough to be applied in the area. The supporting skeleton 210 has a coronary sinus so that one skeleton 210 houses section S ₁ , one skeleton 210 houses one section S ₂ , and one skeleton 210 houses another section S _3. 30 is positioned. The elongated bodies 157, 184 may be deployed at the same time as the support skeleton 210, or may be deployed after the support skeleton 210 is deployed. Preferred segment S _3, in particular, can be elongated body 157,184 slides in skeletal guide 211 which is designed to reshape the gradually tissue for a long period of time. In particular, such a structure is automatically and naturally centered in the area surrounding the posterior leaflet and matches the curve of the posterior leaflet reasonably well. If desired, such a “5-region” elongated body can be made of a single material having different diameters used to form different body regions.

It should also be understood that the skeleton 210 may have a stent shape or may have a rib shape as shown in FIGS.
61-63, guides 211 extend between each of the skeletal regions to form an end position skeletal structure having three regions that engage the coronary sinus wall. A combination of an elongated body and a skeletal assembly is shown that is similar to that shown in FIGS.

  Thus, various stabilizing skeletons for preventing movement of the substantially straight and substantially robust body and a combination of the body and stabilizing skeleton 210 for preventing such movement are provided. Yes.

  It is understood that the present invention is by no means limited to the specific structures disclosed herein and / or shown in the drawings, but includes any variations or equivalents encompassed by the claims. Should.

FIG. 1 is a schematic diagram of a portion of the human vascular system. FIG. 2 is a schematic view of a portion of a human heart. FIG. 3 is a schematic diagram of a preferred device formed in accordance with the present invention. FIG. 4 is a series of diagrams showing how to use the apparatus of FIG. 3 to reduce mitral regurgitation. FIG. 5 is a series of diagrams showing how to use the apparatus of FIG. 3 to reduce mitral regurgitation. FIG. 6 is a series of diagrams showing how to use the apparatus of FIG. 3 to reduce mitral regurgitation. FIG. 7 is a series of diagrams showing how to use the apparatus of FIG. 3 to reduce mitral regurgitation. FIG. 8 shows an alternative form of delivery catheter. FIG. 9 shows an alternative formation of a flexible push rod. FIG. 10 illustrates another alternative form of the present invention. FIG. 11 illustrates another alternative form of the present invention. FIG. 12 is an illustration showing an alternative structure for an elongate body that includes one form of the present invention. FIG. 13 is an illustration showing an alternative structure for an elongated body including one form of the present invention. FIG. 14 is an illustration showing an alternative structure for an elongated body including one form of the present invention. FIG. 15 illustrates an alternative device formed in accordance with the present invention. FIG. 16 shows how the device of FIG. 15 is formed during deployment of the elongate body of the device. FIG. 17 is a side view of yet another alternative embodiment of an elongated body. FIG. 18 is a side view of yet another alternative embodiment of an elongated body. FIG. 19 is a side view of yet another alternative embodiment of an elongated body. FIG. 20 is a schematic diagram of the forces engaging the working portion of the assembly of the present invention. FIG. 6 is a schematic diagram of another alternative form of the present invention. FIG. 22 is a schematic diagram showing the structure of FIG. 21 deployed in the coronary sinus. FIG. 23 is a schematic diagram of another alternative form of the present invention. FIG. 24 is a schematic diagram showing the structure of FIG. 23 deployed in the coronary sinus. FIG. 25 is a schematic view of a normal mitral valve. FIG. 26 is a schematic view of a regurgitant mitral valve. FIG. 27 is a schematic diagram showing an elongate body inserted into a coronary sinus, the elongate body including a substantially straight and substantially rigid central portion. FIG. 28 is a schematic diagram showing an elongate body inserted into the coronary sinus, the elongate body including a substantially straight and substantially rigid central portion. FIG. 29 is a schematic diagram illustrating another elongate body inserted into the coronary sinus, the elongate body including a resilient central portion and ends. FIG. 30 is a schematic diagram illustrating another elongate body inserted into the coronary sinus, the elongate body including a resilient central portion and an end. FIG. 31 is a schematic diagram illustrating another elongate body inserted into the coronary sinus, the elongate body having a variable modulus of elasticity along its length. FIG. 32 is a schematic diagram illustrating another elongate body inserted into the coronary sinus, the elongate body having a variable modulus of elasticity along its length. FIG. 33 shows the deformation curves due to the forces of two materials, Nitinol and Stainless Steel. FIG. 34 is a side view of yet another alternative embodiment of the elongate body. FIG. 35 is a side view of yet another alternative embodiment of the elongate body. FIG. 36 is a side view of yet another alternative embodiment of the elongate body. FIG. 37 is a side view showing the elongate body in cooperating engagement with the stabilizing skeleton. 38 is a cross-sectional view showing one step in the deployment of the stabilizing framework of FIG. 39 is a schematic view of the elongate body of FIG. 37 shown in place within the coronary sinus. FIG. 40 is a schematic view of another embodiment of the present invention. 41 is a cross-sectional view taken along the plug 41-41 in FIG. FIG. 42 is a schematic view of another embodiment of the present invention. 43 is a cross-sectional view taken along line 43-43 in FIG. FIG. 44 is a schematic view of another embodiment of the present invention. 45 is a cross-sectional view taken along line 44-44 in FIG. FIG. 46 is a schematic diagram illustrating the structure of FIGS. 40-45 as deployed in the coronary sinus. FIG. 47 is a schematic view of another embodiment of the present invention. FIG. 48 shows an alternative structure for engaging the elongate body and the stabilizing skeleton. FIG. 49 shows an alternative structure for engaging the elongated body and the stabilizing skeleton. FIG. 50 shows an alternative structure for engaging the elongated body and the stabilizing skeleton. FIG. 51 shows an alternative structure for engaging the elongated body and the stabilizing skeleton. 52 is a perspective view of a combination of the elongated body and the stabilizing skeleton of FIG. FIG. 53 is a perspective view of an elongated body with ribs extending therefrom. 54 is a top view of the elongated body and rib assembly of FIG. FIG. 55 is a perspective view of another combination of an elongated body and a stabilizing skeleton. FIG. 56 is a perspective view of a combination of an elongated body and a stabilizing skeleton, wherein the structure of the stabilizing skeleton includes a plurality of elongated body components. FIG. 57 is a side view of an elongated body that is entirely constituted by a stabilizing skeleton member. FIG. 58 is a side view showing another combination of an elongated body and a stabilizing framework formed in accordance with the present invention. FIG. 59 is a side view showing the stabilizing skeleton of FIG. 57 deployed in the coronary sinus of the patient. FIG. 60 is a side view showing the elongate body / stabilizing skeleton combination of FIG. 57 deployed in the coronary sinus of a patient. FIG. 61 is a side view of another combination of an elongated body and a stabilizing framework formed in accordance with the present invention. 62 is a side view showing the stabilizing skeleton of FIG. 60 in a deployed state in the patient's coronary sinus. 63 is a side view showing the stabilizing skeleton of FIG. 60 in a deployed state in a patient's coronary sinus.

Claims (23)

A device for reducing mitral regurgitation,
An elongate body having a distal end, a proximal end, and an intermediate portion, wherein the distal end and the proximal end are posterior to the wall of the coronary sinus when placed in the coronary sinus near the posterior leaflet of the mitral valve The intermediate portion applies a forward force to the wall of the coronary sinus, thereby moving the posterior annulus of the mitral valve forward to improve the connection of the valve leaflets. a body includes a rod having a relatively straight shape in an unstressed state, the rod is more robust than the anatomical tissue disposed between the rod and the mitral valve The body adapted to move the posterior annulus forward to improve valvular junction by the placement of the rod in the coronary sinus ;
A stabilizing framework coupled to the rod . A device for reducing mitral regurgitation,
A substantially straight elongate body adapted to be inserted into a coronary sinus near the posterior leaflet of a patient's mitral valve, the full length of the coronary sinus being near the posterior leaflet of the mitral valve Relative to the natural curvature of the coronary sinus when the substantially straight elongated body is disposed within the coronary sinus, at least a portion of the coronary sinus is substantially straight adjacent the posterior leaflet of the mitral valve. is a structure, thereby including a substantially straight body has a length such that improve the bonding of the leaflets thereby and moves the mitral annulus forward by increasing the curvature radius of the mitral valve annulus,
The body is more robust than the anatomical tissue disposed between it and comprise and and the device rod having a substantially straight shape as the mitral valve in a non-stressed state, whereby, The placement of the device within the coronary sinus is adapted to move the posterior annulus forward to improve valve joints ;
The apparatus further comprises a stabilizing framework coupled to the rod . A device for reducing mitral regurgitation,
A substantially rigid elongated body adapted to be inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve, the original body of the coronary sinus near the posterior leaflet of the mitral valve Such that when the substantially rigid elongate body is positioned within the coronary sinus, at least a portion of the coronary sinus exhibits a different structure adjacent to the posterior leaflet of the mitral valve A substantially rigid elongate body configured to move the rear annulus forward and thereby improve the joint of the leaflet,
The body includes a rod that has a substantially straight shape in an unstressed state and is more robust than the anatomical tissue disposed between the rod and the mitral valve, thereby The placement of the device within the coronary sinus is adapted to move the posterior annulus forward to improve valve joints ;
The apparatus further comprises a stabilizing framework coupled to the rod . A device for reducing mitral regurgitation,
A substantially straight and substantially robust elongated body adapted to be inserted into the coronary sinus near the posterior leaflet of a patient's mitral valve, the length of which is the length of the posterior leaflet of the mitral valve At least a portion of the coronary sinus is located in the coronary sinus when the substantially straight and substantially rigid elongated body is disposed within the coronary sinus with respect to the natural curvature of the coronary sinus nearby. adjacent to the rear leaflet is substantially straight structure, whereby the length so as to improve the bonding of the leaflets thereby and moves the mitral annulus forward by increasing the curvature radius of the mitral valve annulus Including the almost straight body,
The body is robust than substantially and includes a bar having a straight shape are disposed between the rod and the mitral valve anatomy in a non-stressed state, it By the placement of the device in the coronary sinus, the posterior annulus is moved forward to improve valvular junction ,
The apparatus further comprises a stabilizing framework coupled to the rod . The apparatus according to claim 4 , comprising:
And further comprising a delivery catheter adapted to be placed in the coronary sinus of the patient, said delivery catheter being made of a flexible material substantially in the shape of a coronary sinus and said substantially straight A device adapted to house a substantially rigid elongated body therein. The apparatus according to claim 4 , comprising:
The apparatus further comprising a removable guide wire for positioning the delivery catheter within the coronary sinus. The apparatus according to claim 4 , comprising:
A guide wire adapted to be placed in the coronary sinus, the guide wire being made of a flexible material so as to have a substantially coronary sinus shape; A device into which a cannula is inserted such that a substantially straight and substantially rigid elongated body is carried along the guidewire. The apparatus according to claim 4 , comprising:
The coronary sinus when at least one of the distal end and proximal end of the substantially straight and substantially rigid elongated body is disposed within the coronary sinus A device that includes a flexible portion for relieving stress on the body. The apparatus according to claim 4 , comprising:
The coronary sinus when at least one of the distal end and proximal end of the substantially straight and substantially rigid elongated body is disposed within the coronary sinus A device that is beveled to relieve stress on it. The apparatus according to claim 4 , comprising:
The device wherein the substantially straight and substantially rigid elongated body is shorter in length than the coronary sinus portion disposed between the coronary ostium and the AIV. The apparatus of claim 5 , comprising:
The delivery catheter is configured to prevent delivery of the delivery catheter into the inferior vena cava when the substantially straight and substantially rigid elongated body is passed through the delivery catheter. A device further comprising a support catheter. A device for reducing mitral regurgitation,
An elongated body adapted to be inserted into the coronary sinus near the posterior leaflet of the patient's mitral valve;
The device reverses the natural bend of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve, thereby moving the mitral annulus forward to improve mitral valve junctions, A device comprising a rod and a stabilizing skeleton coupled to the rod.   A device for reducing mitral regurgitation,
  Includes an elongate rod that is adapted to be inserted into the coronary sinus near the posterior leaflet of the mitral valve, the rod having an unstressed straight shape and butts end to end Are arranged in five areas,
  A central region having a selected first degree of flexibility that provides sufficient robustness to reshape the mitral valve;
  A pair of intermediate regions each having a second degree of selected flexibility that is disposed at opposite ends of the central region and imparts a robustness greater than the robustness of the central region;
  Each of the end portions of the intermediate region is disposed at a far end opposite to the end portion disposed in the central region, and is higher than the flexibility of the central region and the intermediate region. A pair of outer regions having a third degree of flexibility,
  Thereby, when the rod is inserted into the coronary sinus, the central region functions to realign the shape of the mitral annulus, and the middle region loads to realign the shape To the outer region, the outer region functioning to distribute the load into the side wall of the coronary sinus.   An apparatus according to claim 13,
  The device wherein the central region is more robust than an anatomical tissue disposed between the coronary sinus and the mitral annulus.   An apparatus according to claim 14,
  The device wherein the central region has a length sufficient to cause a portion of the coronary sinus to have a more straight shape.   An apparatus according to claim 14,
  The central region has a straighter shape than the shape of the coronary sinus near the posterior leaflet of the mitral valve and the curvature of the coronary sinus to impart a force to straighten the wall of the coronary sinus A device with a length relative to the radius.   An apparatus according to claim 13,
  Each of the regions is made of a single material, the central region has a first diameter, each of the intermediate regions has a second diameter, and the outer region The device is given a third diameter in the area.   An apparatus according to claim 13,
  The central region is adapted to apply a forward force to the wall of the coronary sinus adjacent to the posterior leaflet of the mitral valve, and each of the outer regions is posterior to the wall of the coronary sinus. A device designed to exert power.   An apparatus according to claim 13,
  An apparatus in which each of the regions includes a uniform bar-shaped portion.   An apparatus according to claim 13,
  An apparatus in which each of the regions is coupled to at least another region of the region by a coupling unit.   An apparatus according to claim 13,
  A device in which the rod is made of a superelastic material.   An apparatus according to claim 13,
  A flexible delivery catheter adapted to be placed in the patient's coronary sinus such that the delivery catheter assumes the shape of a coronary sinus A device made of material and adapted to receive the rod therein.   An apparatus according to claim 22;
The apparatus further comprising a removable guide wire for positioning the delivery catheter within the coronary sinus.

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