CN1829485B - Method and apparatus for improving mitral valve function - Google Patents

Abstract

A method and device for reducing mitral valve regurgitation are provided herein. The device is inserted into the coronary sinus adjacent to the posterior leaflet of a patient's mitral valve and is adapted to straighten the intrinsic curvature of at least a portion of the coronary sinus adjacent to the posterior leaflet of the mitral valve to displace the posterior annulus anteriorly, thereby improving leaflet coaptation and reducing mitral valve regurgitation.

Description

Methods and devices for improving mitral valve function

Citations of pending prior patent applications

This patent application:

(1) is prior pending U.S. Patent Application No. 10/068264, filed 02/05/02 by Daniel C. Taylor et al., entitled "Method and Apparatus for Improving Mitral Valve Function" (Attorney Docket No. VIA-29) part of the continuation application;

(2) is prior pending U.S. Patent Application No. 10/112,354, filed 03/29/02 by John Liddicoat et al., entitled "Methods and Apparatus for Improving Mitral Valve Function," (Attorney Docket No. .VIA-19202122) part of the continuation application;

(3) is prior pending U.S. Patent Application No. 10/218,649, filed 08/14/02 by Daniel C. Taylor et al., entitled "Methods and Apparatus for Improving Mitral Valve Function" (Attorney Docket No. VIA-23) part of the continuation application;

(4) is prior pending U.S. Patent Application No. 10/280401, filed 10/25/02 by William E. Cohn et al., entitled "Methods and Apparatus for Improving Mitral Valve Function" (Attorney Docket No. VIA-30) part of the continuation application;

(5) is prior pending U.S. Patent Application No. 10/342034, filed 01/14/03 by Daniel C. Taylor et al., entitled "Methods and Apparatus for Reducing Mitral Valve Regurgitation" (Attorney Docket No. VIA-31) part continuation application; and

(6) Claiming Priority to Prior U.S. Patent Application, filed 06/26/02 by William E. Cohn et al., entitled "Method and Apparatus for Improving Mitral Valve Function" (Attorney Docket No. VIA -34 PROV) Interest in No. 60/391790.

The above six patent applications are incorporated herein 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.

Background of the invention

Mitral valve repair is the surgical option for the treatment of all pathogenic mitral regurgitation. With current surgical techniques, between 70% and 95% of regurgitant mitral valves can be repaired. The advantages of mitral valve repair over mitral valve replacement are well documented. These advantages include better preservation of cardiac function and reduced risk of bleeding, thromboembolism, and endocarditis associated with anticoagulants.

In current practice, mitral valve surgery requires extremely invasive procedures that include incision of the chest wall, cardiopulmonary bypass, cardiopulmonary arrest, and incision of the heart itself to gain access to the mitral valve. This surgery is associated with high morbidity and mortality. Because of the risks associated with this procedure, many frail patients do not enjoy the potential benefits of surgical management of mitral regurgitation. In addition, patients with mitral regurgitation with moderate symptoms cannot be intervened at an early stage, and surgical treatment can only be performed after the development of cardiac dysfunction to a certain extent.

Mitral regurgitation commonly occurs in patients with heart failure and is an important cause of morbidity and mortality in these patients. Mitral regurgitation in patients with heart failure is caused by changes in the geometry of the left ventricle, papillary muscle, and mitral annulus. These geometrical changes cause the mitral valve leaflets to fail to fully coapt during systole. In such cases, mitral regurgitation can be treated by crimping the mitral annulus with sutures alone or with a combination of sutures and support rings, thereby reducing the circumference of the dilated annulus and restoring the mitral valve The original geometry of the torus.

More specifically, current surgical practice for mitral valve repair typically requires the left atrium to be surgically opened and sutures, or more generally a combination of sutures and support rings, to be secured to the interior surface of the annulus, thereby Reduces the radius of the mitral annulus; this configuration is used to tighten the annulus to a smaller radius with a purse-string suture, thereby reducing mitral regurgitation by improving leaflet coaptation.

This repair of the mitral valve is commonly referred to as "annuloplasty" and is effective in reducing mitral regurgitation in heart failure patients. This in turn alleviates heart failure symptoms, improves quality of life and increases longevity. Unfortunately, however, the invasiveness of mitral valve surgery and the associated risks result in only a minority of most heart failure patients undergoing surgery. Thus, a less invasive approach to improve leaflet coaptation and thus reduce mitral regurgitation in heart failure patients could make this therapy suitable for the vast majority of patients.

Mitral regurgitation also occurs in approximately 20% of patients with acute myocardial infarction. Additionally, in recovery from acute myocardial infarction, mitral regurgitation is the major cause of cardiogenic shock in approximately 10% of patients who develop severe hemodynamic instability. Patients with mitral regurgitation and cardiogenic shock have an approximately 50% hospital mortality rate. Elimination of mitral regurgitation in these patients would be of great benefit. Unfortunately, however, patients with severe mitral regurgitation with acute myocardial infarction as a complication are particularly high-risk surgical candidates and are therefore not good candidates for conventional annuloplasty. Therefore, a non-invasive approach to temporarily reduce or eliminate mitral regurgitation in these extremely sick patients could provide them time to recover from a myocardial infarction or other serious life-threatening condition and make them a better patient. Surgical object for medical, interventional therapy or surgical therapy.

Summary of the invention

It is therefore 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 non-invasive method and device for reducing mitral valve regurgitation.

Another object of the present invention is to provide a method and device for reducing mitral valve regurgitation, which can be permanently (such as for heart failure patients) or temporarily (such as for patients with mitral valve regurgitation and patients with acute myocardial infarction).

These and other objects are achieved by the present invention, which includes an improved method and apparatus for reducing mitral valve regurgitation.

In one form of the invention there is provided a method for reducing mitral valve regurgitation comprising:

Insertion of a device into the coronary sinus near the posterior leaflet of the patient's mitral valve, the device being adapted to straighten at least a portion of the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly , thereby improving leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a device into the coronary sinus near the posterior leaflet of the patient's mitral valve, the device being adapted to move forward at least a portion of the coronary sinus near the posterior leaflet of the mitral valve to move the posterior annulus forward, thereby Improved leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting into the patient's coronary sinus adjacent to the posterior leaflet of the mitral valve a device adapted to reduce the degree of inherent curvature of at least a portion of the coronary sinus adjacent to the posterior leaflet of the mitral valve so as to anteriorly forward the posterior annulus movement, thereby improving leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting into the coronary sinus near the posterior leaflet of the patient's mitral valve a device adapted to increase the intrinsic radius of curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve to move the posterior annulus anteriorly, Thereby improving leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

Inserting a device into the coronary sinus near the posterior leaflet of a patient's mitral valve, the device having a distal end, a proximal end, and a medial portion, the device configured to be positioned in the coronary sinus near the posterior leaflet of the mitral valve , the distal and proximal portions will exert a posterior force on the wall of the coronary sinus, while the medial portion will exert an anterior force on the wall of the coronary sinus in order to move the posterior annulus forward, thereby improving leaflet coaptation .

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

A generally flat, elongated body having a length relative to the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve is inserted into the patient's coronary sinus near the posterior leaflet of the mitral valve. Dimensioned such that when the generally flat elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a generally flat configuration adjacent the posterior leaflet of the mitral valve, so as to increase the mitral annulus The radius of curvature of the body improves leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a substantially rigid elongated body into the coronary sinus near the posterior leaflet of the patient's mitral valve, the substantially rigid elongated body positioned relative to the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve such that This generally rigid elongated body, when positioned in the coronary sinus, will cause at least a portion of the coronary sinus to assume a different configuration near the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly, improving the leaflet join.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a generally flat and generally rigid elongated body into the coronary sinus near the posterior leaflet of the patient's mitral valve, the length of the generally flat and generally rigid elongated body relative to the vicinity of the posterior leaflet of the mitral valve The inherent curvature of the coronary sinus is sized so that when the generally flat and generally rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to appear generally flat near the posterior leaflet of the mitral valve. Straight configuration in order to increase the radius of curvature of the mitral annulus, thereby improving leaflet coaptation.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a body having a distal end, a proximal end, and an intermediate portion, the body being configured such that when the body is positioned in the coronary sinus near the posterior leaflet of the mitral valve, the distal and proximal ends will exert a posterior action on the wall of the coronary sinus force, while the medial portion will exert an anterior force on the wall of the coronary sinus in order to move the posterior annulus of the mitral valve anteriorly, thereby improving leaflet coaptation.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a generally straight, elongated body adapted for insertion into the coronary sinus near the posterior leaflet of the patient's mitral valve, the length of the generally straight, elongated body being relative to the coronary sinus near the posterior leaflet of the mitral valve The inherent curvature of the mitral valve is tailored so that when the generally flat elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a generally flat configuration near the posterior leaflet of the mitral valve in order to increase The radius of curvature of the mitral annulus allows it to move anteriorly, thereby improving leaflet coaptation.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a substantially rigid elongated body adapted for insertion into the coronary sinus near the posterior leaflet of the patient's mitral valve, the substantially rigid elongated body being relatively rigid with respect to the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve configured such that when the substantially rigid elongated body is positioned in the coronary sinus it will cause at least a portion of the coronary sinus to assume a different configuration adjacent the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly, Thereby improving leaflet coaptation.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a generally straight and generally rigid elongated body adapted for insertion into the coronary sinus near the posterior leaflet of the patient's mitral valve, the length of the generally straight and generally rigid elongated body being relative to the posterior leaflet of the mitral valve The inherent curvature of the coronary sinus near the posterior leaflets of the mitral valve is tailored so that when the generally flat and generally rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to appear near the posterior leaflet of the mitral valve. A generally flat configuration in order to increase the radius of curvature of the mitral annulus, allowing it to move anteriorly and thereby improve leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

Insertion of a device into the coronary sinus near the posterior leaflet of the patient's mitral valve, the device being adapted to straighten at least a portion of the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly , thereby improving leaflet coaptation;

The device includes an elongated body having a degree of curvature less than that of the coronary sinus in an unstressed state prior to insertion of the elongated body into the coronary sinus, and the device is more rigid than when the device and the two The anatomy between the cusps such that placement of the device in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a device into the coronary sinus near the posterior leaflet of the patient's mitral valve, the device being adapted to move forward at least a portion of the coronary sinus near the posterior leaflet of the mitral valve to move the posterior annulus forward, thereby Improved leaflet coaptation;

The device comprises an elongated body having a straighter structure than the coronary sinus in an unstressed state prior to insertion of the elongated body into the coronary sinus, and the device is more rigid than the The tissue is dissected such that placement of the device in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting into the coronary sinus near the posterior leaflet of the patient's mitral valve a device adapted to reduce the degree of inherent curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly , thereby improving leaflet coaptation; the device includes an elongated body with a relatively straight configuration in the unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, allowing the device to be positioned in the coronary sinus The placement in will move the posterior annulus forward and improve leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting into the coronary sinus near the posterior leaflet of the patient's mitral valve a device adapted to increase the intrinsic radius of curvature of at least a portion of the coronary sinus near the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly , thereby improving leaflet coaptation;

The device includes an elongated body with a relatively straight configuration in the unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, so that placement of the device in the coronary sinus will The annulus moves forward and improves leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a device into the coronary sinus near the posterior leaflet of a patient's mitral valve, the device having a distal end, a proximal end and an intermediate portion, the device being configured to be positioned in the coronary sinus near the posterior leaflet of the mitral valve , the distal and proximal portions will exert a posterior force on the wall of the coronary sinus, while the medial portion will exert an anterior force on the wall of the coronary sinus in order to move the posterior annulus anteriorly, thereby improving leaflet coaptation;

The device includes an elongated body with a relatively straight configuration in the unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, so that placement of the device in the coronary sinus will The annulus moves forward and improves leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

A generally flat, elongated body having a length relative to the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve is inserted into the patient's coronary sinus adjacent to the posterior leaflet of the mitral valve. Tailored so that when the generally flat elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a generally flat configuration adjacent the posterior leaflet of the mitral valve so as to increase the mitral annulus radius of curvature, thereby improving leaflet coaptation;

The generally flat elongated body includes a rod having a generally flat configuration in an unstressed state, and the device is more rigid than the anatomical tissue between the device and the mitral valve, allowing the device to remain in the coronary sinus The placement will move the posterior annulus forward and improve leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

A substantially rigid elongated body is inserted into the coronary sinus near the posterior leaflet of the mitral valve of the patient, the substantially rigid elongated body being configured relative to the inherent curvature of the coronary sinus near the posterior leaflet of the mitral valve such that when the A generally rigid elongated body that, when positioned in the coronary sinus, causes at least a portion of the coronary sinus to assume a different configuration near the posterior leaflets of the mitral valve in order to move the posterior annulus anteriorly, thereby improving leaflet coaptation ;

The generally rigid elongated body includes a rod with a relatively straight configuration in the unstressed state, and the device is more rigid than the anatomical tissue between the device and the mitral valve, allowing the device to remain in the coronary sinus. The placement will move the posterior annulus forward and improve leaflet coaptation.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a generally flat and generally rigid elongated body into the coronary sinus near the posterior leaflet of the patient's mitral valve, the length of the generally flat and generally rigid elongated body being relative to the length of the approximately posterior leaflet of the mitral valve The inherent curvature of the coronary sinus is tailored so that when this generally flat and generally rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to appear generally flat near the posterior leaflet of the mitral valve structure in order to increase the radius of curvature of the mitral annulus, thereby improving leaflet coaptation;

The generally flat and generally rigid elongated body includes a rod of generally flat configuration in an unstressed state, and the device is more rigid than the anatomical tissue between the device and the mitral valve, allowing the device to coronally Placement in the sinuses will move the posterior annulus anteriorly and improve leaflet coaptation.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a body having a distal end, a proximal end, and an intermediate portion configured such that when the body is positioned in the coronary sinus near the posterior leaflet of the mitral valve, the distal and proximal ends will exert a posterior force on the wall of the coronary sinus , and the medial portion will exert an anterior force on the wall of the coronary sinus in order to move the posterior annulus of the mitral valve anteriorly, thereby improving leaflet coaptation;

The body includes a rod with a relatively straight configuration in the unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, so that placement of the device in the coronary sinus will allow posterior The annulus moves forward and improves leaflet coaptation.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a generally straight, elongated body adapted for insertion into the coronary sinus near the posterior leaflet of the mitral valve in a patient, the length of the generally straight, elongated body being relative to the intrinsic coronary sinus near the posterior leaflet of the mitral valve The curvature is tailored so that when the generally flat elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a generally flat configuration near the posterior leaflet of the mitral valve in order to increase the The radius of curvature of the annulus, allowing it to move anteriorly, thereby improving leaflet coaptation;

The body includes a stem with a generally flat configuration in an unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, so that placement of the device in the coronary sinus will cause the posterior annulus The body moves forward and leaflet coaptation improves.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a substantially rigid elongated body adapted for insertion into the coronary sinus adjacent the posterior leaflet of the mitral valve in a patient, the substantially rigid elongated body configured relative to the inherent curvature of the coronary sinus adjacent the posterior leaflet of the mitral valve, Such that when the substantially rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a different configuration in the vicinity of the posterior leaflet of the mitral valve in order to move the posterior annulus anteriorly, thereby improving the leaflet join;

The body includes a stem with a generally flat configuration in an unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, so that placement of the device in the coronary sinus will cause the posterior annulus The body moves forward and leaflet coaptation improves.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

a generally straight and generally rigid elongated body adapted for insertion into the coronary sinus of a patient adjacent to the posterior leaflet of the mitral valve, the length of the generally straight and generally rigid elongated body being relative to the posterior leaflet of the mitral valve The inherent curvature of the nearby coronary sinus is tailored so that when this generally flat and generally rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to appear approximately A flat configuration to increase the radius of curvature of the mitral annulus, allowing it to move anteriorly, thereby improving leaflet coaptation;

The body includes a stem with a generally flat configuration in an unstressed state, and the device is more rigid than the anatomy between the device and the mitral valve, so that placement of the device in the coronary sinus will cause the posterior annulus The body moves forward and leaflet coaptation improves.

In another form of the invention, there is provided a method for reducing mitral valve regurgitation comprising:

inserting a device into the patient's coronary sinus adjacent the posterior leaflet of the mitral valve, the device being adapted to transform at least a portion of the inherent curvature of the coronary sinus adjacent the posterior leaflet of the mitral valve to anteriorly move the posterior annulus, Leaflet engagement is thereby improved, wherein the device includes a rod and a stabilizing bracket connected to the rod.

In another form of the invention, there is provided an apparatus for reducing mitral valve regurgitation comprising:

an elongated body adapted to be inserted into the coronary sinus adjacent to the posterior leaflet of the mitral valve in a patient, the device being adapted to transform the inherent curvature of at least a portion of the coronary sinus adjacent to the posterior leaflet of the mitral valve so that the posterior annulus The body moves forward to improve leaflet engagement, wherein the device includes a rod and a stabilizing bracket connected to the rod.

Importantly, the present invention can be implemented noninvasively, permanently or temporarily, in order to reduce mitral regurgitation.

Brief introduction to the drawings

These and other objects and features of the invention will be more fully disclosed or disclosed by the following detailed description of preferred embodiments of the invention considered in conjunction with the accompanying drawings, in which like reference numerals are used to designate like parts, wherein :

Figure 1 is a schematic diagram of a part of the human vascular system;

Figure 2 is a schematic diagram of a part of a human heart;

Figure 3 is a schematic diagram of a preferred system formed in accordance with the present invention;

4-7 are a set of graphs showing the reduction of mitral valve regurgitation using the system shown in FIG. 3;

Figure 8 shows an alternative form of delivery catheter;

Figure 9 shows an alternative form of flexible push rod;

Figure 10 shows another alternative form of the invention;

Figure 11 shows another alternative form of the invention;

Figures 12-14 show an alternative construction of an elongated body forming a form of the invention;

Figure 15 shows an alternative system formed in accordance with the present invention;

Figure 16 shows the configuration of the system shown in Figure 15 during deployment of the elongated body of the system for use;

17-19 are side views of other alternative embodiments of the elongate body;

Figure 20 is a schematic diagram of the forces acting on the operating portion of the assembly of the present invention;

Figure 21 is a schematic illustration of another alternative form of the invention;

Figure 22 is a schematic diagram showing the structure shown in Figure 21 deployed in the coronary sinus;

Figure 23 is a schematic illustration of another alternative form of the invention;

Figure 24 is a schematic diagram showing the structure shown in Figure 23 deployed in the coronary sinus;

Figure 25 is a schematic diagram of a normal mitral valve;

Figure 26 is a schematic diagram of a regurgitating mitral valve;

27 and 28 are schematic diagrams showing an elongated body inserted into a coronary sinus, wherein the elongated body includes a generally flat and generally rigid central portion;

29 and 30 are schematic diagrams showing another elongated body inserted into a coronary sinus, wherein the elongated body includes a resilient central portion and end portions;

31 and 32 are schematic diagrams showing another elongated body inserted into the coronary sinus, wherein the elongated body has variable elasticity along its length.

Figure 33 is a schematic diagram showing force-deformation curves for two materials, Nitinol and stainless steel;

34 and 35 are side views of other alternative embodiments of the elongated body;

Figure 36 is a schematic illustration of another alternative embodiment of an elongated body;

Figure 37 is a schematic side view showing the elongated body of Figure 35 cooperatively engaged with a stabilizing bracket;

Figure 38 is a schematic cross-sectional view of a step configured in the stabilizing bracket shown in Figure 37;

39 is a schematic illustration of the elongated body and stabilizing scaffold of FIG. 37 shown in the coronary sinus;

Figure 40 is a schematic diagram of another form of the present invention;

Figure 41 is a cross-sectional view along line 41-41 in Figure 40;

Figure 42 is a schematic diagram of another form of the present invention;

Figure 43 is a cross-sectional view along line 43-43 in Figure 42;

Figure 44 is a schematic diagram of another form of the present invention;

Figure 45 is a cross-sectional view along line 44-44 in Figure 44;

Figure 46 is a schematic diagram showing the configuration of Figures 40-45 deployed in the coronary sinus;

Figure 47 is a schematic diagram of another form of the present invention;

Figures 48-51 show alternative configurations for combining an elongated body and a stabilizing bracket;

Figure 52 is a schematic perspective view of the combination of the elongated body and stabilizing bracket shown in Figure 51;

Figure 53 is a perspective view of an elongated body having ribs extending therefrom;

Figure 54 is a top plan view of the elongated body and rib assembly shown in Figure 53;

Figure 55 is a schematic perspective view of another combination of an elongate body and a stabilizing bracket;

Figure 56 is a schematic perspective view of the combination of an elongate body and a stabilizing bracket, wherein the structure of the stabilizing bracket includes a plurality of elongate body components;

Figure 57 is a schematic side view of an elongated body constructed entirely of stabilizing frame members;

Figure 58 is a schematic side view showing another combination of an elongated body and a stabilizing bracket formed in accordance with the present invention;

Fig. 59 is a schematic side view showing the stabilizing brace of Fig. 57 deployed in a patient's coronary sinus;

60 is a schematic side view showing the combination of the elongated body and stabilizing bracket of FIG. 57 deployed in the coronary sinus of a patient;

Figure 61 is a schematic side view showing another combination of an elongated body and a stabilizing bracket formed in accordance with the present invention;

Fig. 62 is a schematic side view showing the stabilizing brace of Fig. 60 deployed in a patient's coronary sinus; and

Fig. 63 is a schematic side view showing the combination of the elongate body and stabilizing bracket of Fig. 60 deployed in a patient's coronary sinus.

Detailed description of the preferred embodiment

The coronary sinus is the largest vein in the human heart. During most of its course into the atrioventricular groove, the coronary sinus usually extends to a distance of about 5 to 10 centimeters near the left atrium of the heart. Importantly, a portion of the length of the coronary sinus, eg typically about 7-9 cm, extends approximately to the vicinity of the posterior perimeter of the mitral valve annulus. The present invention takes advantage of this fact. More specifically, by deploying a novel device in the coronary sinus near the posterior leaflet of the mitral valve, the intrinsic curvature of the coronary sinus near the posterior leaflet of the mitral valve can be modified so that the posterior annulus Move forward to improve leaflet coaptation, thereby reducing mitral regurgitation.

In a preferred embodiment of the invention, the novel device comprises an elongated body of generally flat configuration, the length of which is made such that when the elongated body is positioned in the coronary sinus near the posterior leaflet of the mitral valve, , the elongated body will cause at least a portion of the coronary sinus to appear relatively flat near the posterior leaflets of the mitral valve in order to move the posterior annulus anteriorly and thereby improve leaflet coaptation.

In a preferred embodiment of the invention, the coronary sinus is accessed percutaneously, for example, by introducing the elongated body into the patient's vasculature via the jugular vein or via the left subclavian vein, passing down the superior cavity The vein, which passes through the right atrium, then enters the coronary sinus and sets there. Alternatively, the elongated body may be introduced into the coronary sinus by making a small incision in the heart or through some other incision into the patient's vasculature.

In a preferred embodiment of the present invention, the elongate body is introduced into place in the coronary sinus by (i) passing it through a pre-positioned catheter, and/or (ii) over a pre-positioned guidewire The elongated body is delivered, and/or (iii) delivered to the surgical site in an unguided manner (eg, on the tip of a steerable delivery tool).

Once deployed, the novel device can be left in place permanently (such as in the case of patients with mitral regurgitation associated with heart failure), or it can be left in place only temporarily. Location (eg in the case of a patient with mitral regurgitation associated with acute myocardial infarction).

Visualization of the surgical procedure can be achieved by fluoroscopy, echocardiography, intravascular ultrasound, vascular microscopy, real-time magnetic resonance imaging, etc. The efficacy of the surgical procedure can be determined by echocardiography, although other imaging modalities are also suitable.

Turning now to FIG. 1 , various aspects of a patient's cardiovascular system 3 are shown. More specifically, cardiovascular system 3 generally includes heart 6 , superior vena cava 9 , right subclavian vein 12 , left subclavian vein 15 , jugular vein 18 and inferior vena cava 21 . The superior vena cava 9 and the inferior vena cava 21 communicate with the right atrium 24 of the heart. Coronary ostia 27 lead to coronary sinus 30 . At the distal end 31 (Fig. 2) of the coronary sinus 30, the vasculature opens into a vertically descending anterior interventricular vein (AIV) 32 (see Figs. 1 and 2). For purposes of the present invention, it is generally convenient to consider the term "coronary sinus" to refer to the vascular structure extending between the coronary ostium 27 and the AIV 32.

Between the coronary ostia 27 and the AIV 32, the coronary sinus 30 extends approximately to about the posterior perimeter of the annulus 33 of the mitral valve 36, as shown in FIG. The mitral valve 36 includes a posterior leaflet 39 and an anterior leaflet 42 . In the event of mitral valve regurgitation, the posterior leaflet 39 and anterior leaflet 42 will generally not coapt properly during systole, leaving an intermediate gap 45 that allows adverse regurgitation to occur.

Referring next to FIG. 3, there is shown a system 100 including a preferred embodiment of the present invention. More specifically, system 100 generally includes guidewire 103 , delivery catheter 106 and pushrod 109 .

Lead 103 includes a flexible body 112 having a distal end 115 and a proximal end 118 . The distal end 115 of the guidewire 103 preferably includes a resilient top 121 that allows the distal end of the guidewire 103 to be passed noninvasively through the vasculature, eg, when the guidewire 103 is passed through the patient's vasculature.

Delivery catheter 106 includes a flexible body 124 having a distal end 127 and a proximal end 130 , and is preferably connected to an adjustable valve 133 . Central lumen 136 extends from distal end 127 to proximal end 130 . In some cases a securing mechanism may be provided for securing the distal end 127 of the delivery catheter 106 within the vasculature. By way of example and not limitation, an inflatable balloon 139 is positioned around the exterior of flexible body 124 , just near distal end 127 , and inflation lumen 142 extends between balloon 139 and inflation joint 145 .

Pushrod 109 includes a flexible body 148 having a distal end 151 and a proximal end 154 . Formed on flexible body 148 proximate distal end 151 is a generally straight and generally rigid elongated body 157 of various lengths. A movable proximal stiffener (or handle) 160 is provided between the elongate body 157 and the proximal end 154 to facilitate manual gripping of the flexible body 148 for advancement or retraction purposes.

System 100 may be used to reduce mitral valve regurgitation as described below.

The distal end 115 of the guide wire 103 is first passed down the patient's jugular vein 18 (or left subclavian vein 15 ), down to the superior vena cava 9 , through the right atrium 24 of the heart, and then along the coronary sinus 30 . See Figure 4. It will be appreciated that as the flexible guidewire 103 is passed down into the coronary sinus 30, due to the flexibility of the guidewire, the guidewire will tend to assume the natural curved shape of the coronary sinus. The non-traumatic resilient top 121 of the lead will help ensure minimal trauma to the vascular structure when the lead 103 is steered into position.

The distal end 127 of the delivery catheter 106 is then positioned over the proximal end 118 of the guidewire 103 and passed down the guidewire until the distal end 127 of the delivery catheter 106 is positioned in the coronary sinus 30 . See Figure 5. It should also be understood that as the flexible delivery catheter 106 is passed down into the coronary sinus, due to the flexibility of the delivery catheter, the catheter will tend to assume the natural curved shape of the coronary sinus.

Once the delivery catheter 106 is positioned in the coronary sinus, the guide wire 103 is removed. See Figure 6. Balloon 139 may be inflated to secure distal end 127 of delivery catheter 106 in coronary sinus 30 before or after guidewire 103 is removed.

The push rod 109 is then passed down into the central lumen 136 of the delivery catheter 106 . The generally straight and generally rigid elongated body 157 of the pushrod forces the delivery catheter 106 in a generally straight and generally rigid position as it passes through the central lumen 136 of the delivery catheter 106 . The generally rigid elongated body 157 presents a generally flat configuration in its current position (FIG. 7). As the push rod 109 is pushed down the delivery catheter 106 , the balloon 139 will act to secure the distal end 127 of the delivery catheter 106 in the coronary sinus 30 .

The push rod 109 can be pushed down the delivery catheter 106 ( FIG. 3 ) using the proximal handle 160 as needed until the generally straight and generally rigid elongated body 157 is positioned in the posterior annulus 33 of the mitral valve 36. nearby. See Figure 7. When this occurs, the presence of the generally flat and generally rigid elongated body 157 in the delivery catheter 106 will cause at least a portion of the coronary sinus 30 to assume a generally flat configuration at this point such that the mitral valve 36 The rear ring body 33 is pressed forward. This will cause the posterior leaflets 39 of the mitral valve to also move forward, thereby improving the leaflet coaptation of the mitral valve and thus reducing (or completely eliminating) mitral valve regurgitation. It should be understood at this point that the posterior annulus can be moved forward to achieve or attempt to achieve anatomically possible leaflet-leaflet coaptation or leaflet-annulus coaptation (e.g. in the case of left ventricular distortion that binds the leaflets ). The terms "improved leaflet coaptation" and/or "enhanced leaflet coaptation" and the like are used herein to encompass both types of coaptation or target coaptation. The exact position of the generally flat and generally rigid elongated body 157 can be adjusted to reduce (or completely eliminate) regurgitation in the mitral valve 36 using standard visualization means such as echocardiography and/or fluoroscopy. .

It should be appreciated in this regard that the generally flat and generally rigid elongated body 157 is preferably dimensioned to be slightly less than the length of the coronary sinus located between the coronary ostia 27 and the AIV 32. In some instances, however, it may be desirable to dimension the generally flat and generally rigid elongated body 157 so that it extends beyond the coronary sinus 30 and into the right atrium 24 .

It should also be appreciated that the system provides a degree of tactile feedback to the user during configuration. More specifically, considerable resistance will generally be encountered as the generally flat and generally rigid elongated body 157 is pushed out of the right atrium 24 into the coronary sinus 30; and then as the distal end 151 of the pushrod 109 (FIG. 3) and/or the anterior end of the body 157 approaches the distal end 31 of the coronary sinus, the resistance will typically increase significantly again. Thus, when the generally flat and generally rigid elongated body 157 is positioned in the coronary sinus between the coronary ostium 27 and the AIV 32, there are certain tactile "effective points" that facilitate The user properly positions the generally straight and generally rigid elongated body 157 in the coronary sinus 30 .

At this point during the procedure, the generally flat and generally rigid elongated body 157 is locked and the balloon 139 deflated, eg, by closing the catheter's adjustable valve 133 (Fig. 3).

System 100 (without wire 103, which has been removed) remains in this position until it is no longer needed. In some cases (eg, in the case of a patient suffering from mitral regurgitation associated with acute myocardial infarction), this may mean that the system 100 will remain in this position for hours, days or weeks. In other cases, such as in the case of a patient suffering from mitral regurgitation associated with heart failure, the system 100 is essentially permanent. If the system 100 is to be removed, the push rod 109 is removed from the delivery catheter 106, and the delivery catheter 106 is removed from the patient.

It can thus be seen that, with the present invention, the generally flat and generally rigid elongated body 157 is generally press fit into the generally curved portion of the coronary sinus near the posterior leaflet of the mitral valve. By correctly sizing the length of the generally flat and generally rigid elongated body 157 relative to the inherent curvature of the patient's anatomy, and by properly positioning the generally flat and generally rigid elongated body 157 on the patient's coronal In the sinuses, this generally flat and generally rigid elongated body will cause at least a portion of the coronary sinus to assume a generally flat configuration near the posterior leaflet 39 of the mitral valve 36 . This action, in turn, moves the posterior annulus of the mitral valve forward, thereby improving leaflet coaptation and thereby reducing mitral regurgitation. Thus, by inserting the generally flat and generally rigid elongated body 157 into the coronary sinus 30 near the posterior leaflet 39 of the mitral valve 36, the annulus 33 of the mitral valve can be effectively manipulated to assume the Increased radius curvature.

By correctly sizing the length of the generally straight and generally rigid elongated body 157 relative to the inherent curvature of the patient's anatomy and by properly positioning the generally straight and generally rigid elongated body 157 In the patient's coronary sinus, the generally flat and generally rigid elongated body 157 will cause at least a portion of the coronary sinus to assume a generally flat configuration near the posterior leaflet 39 of the mitral valve 36, thereby driving the mitral valve The posterior annulus moves forward, improving leaflet coaptation and thus reducing mitral regurgitation. To this end, the push rod 109 is preferably provided as part of a kit having a plurality of different push rods 109, each corresponding to a different sized elongated body 157, so that the physician can adjust for a particular patient anatomy. Structural selection and placement of an appropriately sized elongated body 157 . Furthermore, if at setup it is found (e.g., by echocardiography and/or fluoroscopy) that a different sized elongated body 157 is desired, the second pushrod 109 can be replaced with a second pusher 109 having an elongated body 157 of the desired size. One putt 109.

In a preferred form of the invention, in order to initially determine the proper length of the elongated body 157 for a particular patient anatomy, the diagnostic pushrod 109 may first be inserted into the patient's coronary sinus; Having determined the preferred dimensions of the elongated body 157, a series of different sized diagnostic pushrods 109 can be sequentially inserted into the patient's coronary sinus. Thereafter, an appropriately sized therapeutic pushrod 109 may be inserted into the coronary sinus to improve leaflet coaptation and thereby reduce mitral valve regurgitation.

Additionally, prior to inserting the diagnostic pushrod 109 into the patient's coronary sinus, the physician may perform an initial assessment of the size of the coronary sinus to determine an initial estimated length of the elongated body 157 of the diagnostic pushrod 109 . This can be done in fluoroscopy using a guide wire 103 with radiopaque markers, or by using a delivery catheter 106 with radiopaque markers, or inserting another device with radiopaque markers, such as a flexible element, into the coronary sinus or other methods known to those skilled in the art. Using the radiopaque landmarks, the physician can perform an initial assessment of the size of the coronary sinus in order to determine an initial estimated length of the elongated body 157 of the diagnostic pusher 109; the diagnostic pusher 109 can then be exchanged as needed until the elongated body 157 is determined At this time, the therapeutic push rod 109 is used to replace the diagnostic push rod of suitable size.

It has also been found that by inserting the generally flat and generally rigid elongated body 157 into the coronary sinus near the posterior leaflet of the mitral valve, it is also possible to remodel the patient's left ventricle, thereby helping to relieve congestion Sexual heart failure.

Of particular note is that, in accordance with the present invention, the distal and proximal ends of the generally flat and generally rigid elongated body 157 exert a rearward force on the wall of the coronary sinus 30 (eg, indicated by arrow P in FIG. 7 ). ), and the middle portion of the generally flat and generally rigid elongated body 157 exerts a forward force on the wall of the coronary sinus 30 (eg, indicated by arrow A in FIG. 7 ).

In some cases, the proximal end 130 (FIG. 3) of the delivery catheter 106 can be secured to the patient's skin using standard patient care methods such as tape, purse-string sutures, skin staples, and the like. In other cases, the proximal end 130 of the delivery catheter 106 may include a suture sleeve so that the delivery catheter may be secured to the patient's tissue by suturing. See, for example, FIG. 8 , which shows suture cover 166 attached to proximal end 130 of delivery catheter 106 . If desired, an element 169 may be provided adjacent to the adjustable valve 133 to allow rapid delivery of the flexible pushrod 109 to the delivery catheter 106 without the use of the adjustable valve 133 (FIG. 3). As an example, element 169 includes a crimpable element that can secure flexible pusher 109 to delivery catheter 106 , such as with suture cover 166 , to secure delivery catheter 106 to the patient. If desired, such as in the case of permanent implantation, the proximal end of the assembly can be buried under the patient's skin.

As noted above, it is helpful to anchor the distal end of the delivery catheter 106 in the coronary sinus prior to advancing the pushrod 109 into the delivery catheter. This arrangement will hold the delivery catheter in place as the generally flat and generally rigid elongated body 157 is inverted within the right atrium and into the coronary sinus. In the absence of such anchoring, the push rod may drive the delivery catheter down into 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 when the generally flat and generally rigid elongated body 157 overturns in the coronary sinus against initial resistance, the catheter Stabilize without turning into the inferior vena cava 21 . Balloon 139 is one way to achieve this anchoring. However, other types of fastening mechanisms, such as spring clips, ribs, etc., may also be utilized to anchor the distal end 127 of the delivery catheter 106 in place in the coronary sinus 30 .

If desired, the distal end 151 of the push rod 109 may itself be provided with a tip anchor, such as the tip anchor 172 shown in FIG. 9 . Such end anchors on the pushrod 109 help to hold the generally flat and generally rigid elongated body 157 in place in the coronary sinus 30 .

The delivery catheter 106 is also prevented from turning down into the inferior vena cava 21 without anchoring the distal end of the delivery catheter 106 on the wall of the coronary sinus. More specifically, referring now to FIG. 10 , a support catheter 173 formed of a more rigid material than the flexible body 124 of the delivery catheter 106 is shown. The support catheter 173 is configured to position its distal end 174 in the coronary ostia 27 when the pushrod 109 is passed down through the delivery catheter 106, after which its sidewall 174A supports the delivery catheter 106 in the vicinity of the inferior vena cava 21, In order to prevent the delivery catheter 106 from turning down into the inferior vena cava 21 . FIG. 10 also shows insertion catheter 174B at the entrance to jugular vein 18 .

In the system 100 discussed above, the push rod 109 was described as being advanceable through the delivery catheter 106 to the surgical site, where it remained in the delivery catheter 106, and when the push rod 109 was to be removed, it could be removed first. Push rod 109, and then remove delivery catheter 106. However, once the pusher rod 109 is deployed at the surgical site, the delivery catheter 106 can be removed, leaving only the pusher rod 109 at the surgical site, if desired. See, for example, FIG. 11 .

The push rod 109 can also be advanced directly to the surgical site without having to be delivered through a catheter; in this case, the push rod 109 can self-advance through the interventricular vasculature until deployed in the coronary sinus 30 .

As mentioned above, when the push rod 109 is advanced into the region near the posterior annulus of the mitral valve, the generally flat and generally rigid elongated body 157 will deform the intrinsic structure of the coronary sinus to assume a generally flat shape. straight structure. While this action may induce the desired mitral valve remodeling, it may also induce extreme pressure on the walls of the coronary sinus, particularly at the distal and proximal ends of the generally flat and generally rigid elongated body 157. Stress concentration will occur in these places (see arrow P in Figure 7). To this end, the configuration of the generally flat and generally rigid elongated body 157 can be modified to better distribute these stresses.

More specifically, referring next to FIG. 12 , the distal and proximal ends of the generally flat and generally rigid elongated body 157 include relatively flexible portions 175 that contribute to better stress exerted on the walls of the coronary sinus. ground distribution. Additionally and/or alternatively, any tapers applied to the distal and proximal ends of the generally straight and generally rigid elongated body 157 may be elongated, as shown at 178 in FIG. The applied stress is better distributed on the walls of the coronary sinus. In a preferred form of the invention, referring now to FIG. 14 , the generally flat and generally rigid elongated body 157 includes a relatively long and relatively flexible portion 175 having a relatively elongated cone 178 . Each relatively long and relatively flexible portion 175 including a relatively elongated cone 178 may be as long as the generally straight and generally rigid mid-section of the elongated body 157, or longer, if desired.

Turning next to Figure 15, there is shown a system 181 comprising another preferred embodiment of the present invention. More specifically, system 181 generally includes lead wire 103 , a generally straight and generally rigid elongated body 184 , and push sleeve 187 .

The wire 103 is as described above.

The generally straight and generally rigid elongated body 184 , provided in various lengths, includes a distal end 188 and a proximal end 190 . Central lumen 193 extends between distal end 188 and proximal end 190 . Central lumen 193 may accommodate guidewire 103 .

Push sleeve 187 includes a distal end 194 and a proximal end 196 . Central lumen 199 extends between distal end 194 and proximal end 196 . Central lumen 199 can accommodate guidewire 103 .

System 181 is used in the following manner to reduce mitral valve regurgitation.

The distal end 115 of the lead 103 is first passed through the patient's jugular vein 18 (or left subclavian vein 15 ), down to the superior vena cava 9 , through the right atrium 24 of the heart, and along the coronary sinus 30 . It should be understood that when the flexible guidewire 103 is passed through the coronary sinus 30, due to the flexibility of the guidewire, the guidewire will tend to assume the naturally curved shape of the coronary sinus. The atraumatic elastic top 121 of the lead will help minimize damage to the vascular structure as the lead is advanced into place.

The distal end 188 of the generally straight and generally rigid elongated body 184 is next positioned over the proximal end 118 of the lead 103 and passed down the lead a short distance. The distal end 194 of the push sleeve 187 is then positioned over the proximal end 118 of the guidewire 103, after which the push sleeve 187 is advanced down the guidewire. As the pusher sleeve 187 is advanced along the guidewire, its distal end 194 pushes against the generally straight and generally rigid elongated body 184 in front of it. See Figure 16.

As the generally straight and generally rigid elongated body 184 is passed into the coronary sinus, it will force the coronary sinus to assume a generally flat configuration where the generally straight and generally rigid elongated body 184 currently resides . The push sleeve 187 can be pushed down the wire as needed until the generally straight and generally rigid elongated body 184 is positioned adjacent the posterior annulus of the mitral valve. When this occurs, the presence of the generally flat and generally rigid elongated body 184 in the coronary sinus will cause the coronary sinus to assume a generally flat configuration at this point, allowing the posterior annulus of the mitral valve to The body is pressed forward. This causes the posterior leaflets of the mitral valve to also move forward, thereby improving leaflet coaptation and thus reducing (or completely eliminating) mitral regurgitation. The exact position of the generally flat and generally rigid elongated body can be adjusted to reduce (or completely eliminate) regurgitation in the mitral valve using standard visualization means such as echocardiography and/or fluoroscopy.

If desired, the push sleeve 187 may be provided with a releasable connection interface (eg, a grasper) such that it releasably secures the proximal end 190 of the generally flat and generally rigid elongated body 184 . Such a feature would allow the generally flat and generally rigid elongated body to be pulled back into the coronary sinus for positioning or extraction purposes.

It can thus be seen that, in accordance with the present invention, the generally flat and generally rigid elongated body 184 is substantially press fit into the generally curved portion of the coronary sinus near the posterior leaflet of the mitral valve. By properly machining the length of the generally straight and generally rigid elongated body 184 with respect to the inherent curvature of the patient's anatomy and by properly positioning the generally straight and generally rigid elongated body 184 in the patient's coronary sinus This generally flat and generally rigid elongated body 184 will cause at least a portion of the coronary sinus to assume a generally flat configuration adjacent the posterior leaflet 39 of the mitral valve 36 . This action in turn moves the posterior annulus of the mitral valve forward, thereby improving leaflet coaptation and thereby reducing mitral regurgitation. Thus, by inserting the generally flat and generally rigid elongated body 184 into the coronary sinus 30 near the posterior leaflet 39 of the mitral valve 36, the annulus 33 of the mitral valve can be effectively manipulated to assume the Increased radius curvature.

As described above, the length of the generally straight and generally rigid elongated body 184 is properly machined with respect to the inherent curvature of the patient's anatomy, and by properly positioning the generally straight and generally rigid elongated body 184 on the patient's In the coronary sinus of the mitral valve 36, this generally flat and generally rigid elongated body 184 will cause at least a portion of the coronary sinus to assume a generally flat configuration near the posterior leaflet 39 of the mitral valve 36, which in turn will drive the mitral The posterior annulus of the valve is moved forward, improving leaflet coaptation and thus reducing mitral regurgitation. To this end, the generally straight and generally rigid elongated body 184 is preferably provided as part of a kit that includes a plurality of different generally straight and generally rigid elongated bodies 184, each with a different size In this way, the physician can select and configure the elongated body 184 of appropriate size for a specific patient anatomy. Additionally, if at configuration time it is found (e.g., by echocardiography and/or fluoroscopy) that a different sized elongated body 184 is desired, the first elongated body 184 can be replaced with a second elongated body 184 of the desired size. 184, so as to achieve the desired therapeutic effect.

In a preferred form of the invention, in order to initially determine the proper length of the elongated body 184 for a particular patient's anatomy, the diagnostic elongated body 184 may first be inserted into the patient's coronary sinus; Having determined the preferred size of the therapeutic elongated body 184, a series of different sized diagnostic elongated bodies can be sequentially inserted into the patient's coronary sinus. Thereafter, an appropriately sized therapeutic elongate body 184 may be inserted into the coronary sinus to improve leaflet coaptation and thereby reduce mitral valve regurgitation.

Additionally, prior to inserting diagnostic elongated body 184 into the patient's coronary sinus, the physician may perform an initial assessment of the size of the coronary sinus to determine an initial estimated length of diagnostic elongated body 184 . This can be done in fluoroscopy using a guide wire 103 with radiopaque markers, or inserting another device with radiopaque markers (such as a flexible element) into the coronary sinus, or using other methods known to those skilled in the art. other ways to complete. Using the radiopaque landmarks, the physician can perform an initial assessment of the size of the coronary sinus in order to determine an initial estimated length of the diagnostic elongated body 184; thereafter, exchange the diagnostic elongated body 184 as needed until the diagnostic elongated body 184 is determined The appropriate length of the diagnostic elongated body 184 is replaced by the therapeutic elongated body 184 at this time.

Also as described above, when the generally straight and generally rigid elongated body 184 is advanced into the region near the posterior annulus of the mitral valve, the generally straight and generally rigid elongated body 184 will allow the coronary sinus The intrinsic structure deforms so that it assumes a roughly flat structure. While this action may induce the desired mitral valve remodeling, it may also induce extremes on the walls of the coronary sinus, particularly at the distal and proximal ends of the generally flat and generally rigid elongated body 184. Stress concentration will occur in these places (see arrow P in Figure 7). To this end, the configuration of the generally flat and generally rigid elongated body 184 can be modified to better distribute these stresses.

More specifically, referring next to FIG. 17 , the distal and proximal ends of the generally flat and generally rigid elongated body 184 may include relatively flexible portions 188A, 190A that facilitate the application of pressure on the wall of the coronary sinus. Stress is better distributed. Additionally and/or alternatively, any tapers applied to the distal and proximal ends of the generally straight and generally rigid elongated body 184 may be elongated, as shown at 188B, 190B in FIG. The applied stress is thereby better distributed on the wall of the coronary sinus. In a preferred form of the invention, referring now to FIG. 19, the generally flat and generally rigid elongated body 184 includes a relatively long and relatively flexible portion 188A, 190A having a relatively elongated taper 188B, 190B. The relatively long and relatively flexible portions 188A, 190A, each including the relatively elongated cones 188B, 190B, may be as long as the generally straight and generally rigid mid-section of the elongated body 184, or longer, if desired.

In the previous discussion, the elongated body 157 (or 184) was generally described as being generally flat and generally rigid, with or without a relatively flexible portion 175 (FIG. 12) (or 188A, 190A, FIG. 17) and/or cone 178 (FIG. 13) (or 188B, 190B, FIG. 18) and/or elongate relatively flexible cone portion 175, 178 (FIG. 14) (188A, 188B, 190A, 190B, FIG. 19) . It should be understood, however, that the terms "substantially straight", "substantially rigid", "relatively flexible" etc. are to be read in the context of referring to anatomy and not in an absolute sense.

In general, the elongated body 157 (or 184) is configured such that (1) its middle portion exerts an anterior force on the wall of the coronary sinus (eg, as indicated by arrow A in FIG. 7), and (2) Its distal and proximal ends exert a posterior force on the wall of the coronary sinus (eg, indicated by arrow P in Figure 7). In contrast, a higher central load L1 ( FIG. 20 ) is exerted by the mitral annulus on the middle portion of the elongated body 157 (or 184 ), while the posterior portion of the coronary sinus is on the elongated body 157 ( or 184 ). A small end load L2 is applied on the distal and proximal ends of , (Fig. 20).

This effect can be produced in particular by using the elongated body 157 (or 184), wherein (1) the elongated body 157 (or 184 ) is straighter (but not necessarily perfectly straight), (2) the elongated body 157 (or 184) is more rigid (but not necessarily straight) than the anatomy moved by the configured elongated body 157 (or 184) completely rigid).

As noted above, the distal and proximal ends of the elongated body 157 (or 184) have relatively flexible portions 175 (FIG. 12) (or 188A, 190A, Fig. 17) and/or cone 178 (Fig. 13) (or 188B, 190B, Fig. 18) and/or elongated relatively flexible cone portion 175, 178 (Fig. 14) (188A, 188B, 190A, 190B, Figure 19). Additionally, the flexibility of these portions 175 (188A, 190A), 178 (188B, 190B) and/or 175, 178 (188A, 188B, 190A, 190B) may vary along their length; Body portions 175, 178 (FIG. 14) (188A, 188B, 190A, 190B, FIG. 19) become more flexible as they extend toward their outer ends.

Indeed, it is not required in the present invention that the middle portion of the elongated body 157 (or 184) be absolutely rigid; in fact, as long as it substantially exerts a higher central load L1 on the mitral valve annulus (Fig. 20) With a certain resistance, it can play a satisfactory role. The design can be further improved by having the distal and proximal ends of the elongated body 157 (or 184) offer less resistance to the small end load L2 (Fig. 20) directed by the posterior wall of the coronary sinus. Thus, a satisfactory design can be achieved with a device that has a gradient of stiffness along its length, with the highest stiffness at or near the center and lower stiffness at or near its ends (or conversely, a device with stiffness along its length). A gradient of flexibility over length, with the lowest flexibility at or near the center and higher flexibility at or near its ends). This may be accomplished by tapering the elongated body; and/or by altering its composition and/or material properties; and/or by other techniques apparent to those skilled in the art from this disclosure. Alternatively, a satisfactory design can be achieved with a device that has some degree of flexibility along its entire length; roughly constant.

Thus, as described above, a satisfactory design can be achieved with an elongated body 157 (or 184) where (1) the elongated body 157 (or 184) is relatively thin compared to the inherent curvature of the coronary sinus portion near the posterior leaflet of the mitral annulus. The elongated body 157 (or 184) is straighter (but not necessarily perfectly straight), and (2) the elongated body 157 (or 184) is more straight than the anatomy that is moved by the configured elongated body 157 (or 184) ) is more rigid (but not necessarily perfectly rigid).

In other alternative embodiments, the elongated body 157, 184 may be comprised of two or more generally flat and generally rigid portions R formed from one or more flexible portions F connected together. See, for example, Figures 21 and 22, which illustrate this configuration. By varying the relative lengths of portions R and F, and by varying the relative stiffness of the generally rigid portion R and varying the relative flexibility of the flexible portion F, good annulus movement and thus better mitral regurgitation reduction can be achieved.

Figures 23 and 24 show another preferred construction in which the generally flat and generally rigid elongated body 157, 184 comprises a plurality of sections _S1 , _S2 and _S3 , wherein section _S1 is configured to have a selected degree of Flexibility, section _S2 is configured to have a lower degree of flexibility than section _S1 , and section _S3 is configured to have a higher degree of flexibility than section _S1 . The sections S ₁ , S ₂ and S ₃ can be integral with each other, or connected together by joints. Due to this configuration, section _S1 will carry the load to remodel the mitral annulus, section _S2 will transfer this load laterally to section _S3 , and section _S3 will spread this load laterally to the side wall of the coronary sinus superior. In a preferred form of the invention, portion S ₁ is configured to have a degree of flexibility that supports remodeling of the mitral annulus while allowing portion S ₁ to engage with the mitral annulus at the commissure point. roughly coincides with the arc of curvature; section _S2 is configured to have a sufficiently low degree of flexibility that substantially all of the loads caused by the remodeling of the mitral annulus will be transferred to section _S3 ; and section _S2 has sufficient The length is long so that the backward force acting on the wall of the coronary sinus (eg, indicated by arrow P in FIG. 7 ) is substantially applied on the proximal and distal ends of the valve commissures. In this way, the pure straightening action creates outward pressure that tensions the fibrous continuum of the heart base, rather than between the valve commissures where such force would cause regurgitation. Therein, the configuration is shaped to center itself naturally in the region around the posterior leaflet and to naturally conform to the curvature of the posterior leaflet. If desired, such "five-region" elongated bodies may be formed from one material with different diameters used to form different body regions.

It can thus be seen that, in various alternative embodiments, elongated body 157 and/or 184 is flexible along at least a portion of its length. Regional flexibility and regional rigidity straighten selected locations of the coronary sinus and correspond to the location of the posterior mitral annulus. This can cause regions of the mitral annulus to move anteriorly, creating a regional improvement in leaflet coaptation. Alternatively, the elongated body can be formed by two ends of a filament joined together: by anchoring the two ends relative to the anatomy and tensioning the filament, the naturally curved walls of the coronary sinus can be straightened so that The posterior mitral annulus moves anteriorly, reducing mitral regurgitation.

By varying the rigidity of the elongated bodies 157, 184, a range of anatomical changes can be brought about in the mitral valve. More specifically, Figure 25 shows a normal mitral valve 36 with adequate coaptation of the leaflets 39, 42, while Figure 26 shows a mitral valve 36 with insufficient coaptation of the leaflets 39, 42 producing regurgitation.

The central portion of the elongated body 157, 184 is relatively large and significantly more rigid relative to the anatomy, and the ends of the elongated body 157, 184 terminate in relatively flexible portions (eg, as shown in FIGS. 14 and 19 ). configuration), the movement of the anatomy is substantially as shown in FIGS. 27 and 28 .

The elongated body 157, 184 has a rod that is somewhat flexible at its center _S1 and its ends _S3 and relatively inflexible at its connecting portion _S2 (such as the structure shown in FIGS. 23 and 24 ) In the case of an annulus, it can be made to provide a flexible sling for supporting the annulus and forming a light engagement with the wall of the coronary sinus, such as shown in FIGS. 29 and 30 . In a preferred form of the invention, the elongated body 157, 184 has tailored flexibility along its length to closely conform to the geometry of the natural annulus in order to orient the posterior annulus (and the posterior leaflets) toward The anterior leaflet moves while maintaining the posterior annulus in its natural curvature, as shown in FIGS. 31 and 32 .

In a preferred configuration, the elongated bodies 157, 184 have a tailored geometry and flexibility such that a rearward force acting on the wall of the coronary sinus (eg, indicated by arrow P in FIG. 7 ) will be applied primarily anteriorly, respectively. , The distal and proximal positions of the posterior commissure. See, for example, Figures 30 and 32, which show how the configuration shown applies its forces to the patient's anatomy, i.e. the medial portion exerts a forward force on the wall of the coronary sinus (as indicated by arrow A), while The distal and proximal ends exert a posterior force on the wall of the coronary sinus (arrow P). By applying a rearward force P in the area of the commissures of the valve, lateral jetting in the area of the commissures is minimized and good leaflet coaptation is achieved.

In addition to the foregoing, it should be understood that the amount of force acting on the mitral annulus is a function of the size and geometry of the elongated bodies 157, 184 and their flexibility. In a preferred form of the invention, the size, geometry and elasticity of the elongate body 157, 184 are preferably such that a relatively high force (such as about 2-5 pounds of force) is applied to the center of the mitral valve annulus. In part, thus when the elongate body 157, 184 is inserted into the coronary sinus, substantially complete remodeling of the mitral valve will generally be achieved immediately. In another preferred form of the invention, the size, geometry, and elasticity of the elongate bodies 157, 184 are preferably such that significantly less force (such as about 1-3 pounds of pressure) is exerted on the mitral valve annulus, Thus when the elongated bodies 157, 184 are inserted into the coronary sinus, only partial mitral valve remodeling will normally be achieved immediately; 157, 184, the elongated body will then continue to apply a remodeling force to the mitral annulus even as the anatomy begins to move in response to the load, gradually achieving the desired full remodeling.

In the latter case where the elongated bodies 157, 184 are formed of a resilient material and the desired mitral valve remodeling will be achieved over time, it is often desirable to keep the forces exerted by the elongated bodies 157, 184 relative over time. constant. For this, some materials may be better than others. More specifically, referring next to Fig. 33, a schematic diagram of force-deformation curves for two materials, Nitinol and stainless steel, is shown. As shown in Figure 33, when Nitinol deforms during initial implantation and then relaxes during subsequent tissue remodeling, it exerts a relatively constant force on the tissue; however, when stainless steel deforms and then relaxes, It exerts widely varying forces on tissues. Therefore, the elongated bodies 157, 184 generally need to be formed at least in part from Nitinol or other superelastic material.

In addition to the foregoing, elongated bodies 157 and/or 184 may have various shapes that are not straight along their length. For example, the elongated body may be undulating, helical, or curved along all or part of its length. As an example, elongate body 157 and/or 184 may have a curved configuration capable of translating the inherent curvature of the coronary sinus, ie, bending it toward the anterior annulus. Alternatively, the elongate body has a compound shape along its length, for example it may have a "w" shape with the center of the "w" pointing towards the anterior annulus. Any of these or other alternative shapes can achieve forward movement of the posterior annulus, which results in a reduction in mitral valve regurgitation.

Referring next to Figures 34-36, it can be seen that the elongate body 157 and/or 184 is provided with an annular rib 200 extending radially outwardly from the elongate body 157, 184 (Figures 34 and 35). The ribs 200 engage the walls of the delivery catheter 106, or the walls of the coronary sinus 30 if the delivery catheter 106 is not in use or has been removed, to mitigate displacement of the elongate bodies 157, 184 over time. The rib 200 is also defined by an annular groove 202 ( FIG. 36 ) in the elongate body 157 , 184 , in which case the circumferential face 204 of the rib 200 coincides with the body circumferential face 205 . The rib 200 is provided with a generally flat perimeter 206 (Figs. 34 and 36) or a perimeter 207 of generally frusto-conical configuration (Fig. 35). In the latter case, it is preferred that the bevels 208 of the edges 207 of some ribs 200 face in the proximal direction, while the bevels 208 of the remaining ribs face in the distal direction (Fig. 35). The elongated body 157, 184 includes a flexible portion 175 (FIG. 12) (or 188A, 190A, FIG. 17) and/or a cone 178 (FIG. 13) or (188B, 190B, FIG. 18) and/or an elongated relative In the case of flexible tapered portions 175, 178 (Fig. 14) (or 188A, 188B, 190A, 190B, Fig. 19), ribs 200 may also be formed on these structures.

An alternative embodiment for use with a stabilizing bracket 210 in combination with the elongate bodies 157, 184 shown in FIG. 34 is shown in FIG. In this embodiment, the stabilizing stent 210 comprises a generally cylindrical beam that is placed in the coronary sinus it engages with and is firmly anchored to the wall of the coronary sinus, after which the elongated bodies 157, 184 (and The ribs 200) are placed in the stabilizing bracket 210. The ribs 200 of the elongated bodies 157 , 184 engage portions of the stabilizing bracket 210 such that the elongated bodies are securely anchored in place in the coronary sinus 30 . For example, where stabilizing bracket 210 includes openings between its frame beams, ribs 200 may interact with the frame beams and openings to help lock elongated bodies 157 , 184 to stabilizing bracket 210 .

More specifically, with this form of the invention, the stabilizing stent 210 can be firmly anchored to the wall of the coronary sinus (e.g., by expanding outward, and/or by penetrating into the tissue in the stent hole, and/or by barbs, etc. carried by the stent), and securely anchors the elongated body 157, 184 (with the rib 200 thereon) to the stabilizing stent 210 (e.g., by rib-bracket engagement), thereby (1) helping to secure the Bodies 157, 184 are prevented from moving longitudinally so as to provide a sustained reduction in mitral valve regurgitation, and/or (2) help support coronary sinus 30 at the point where maximum load L1 ( FIG. 20 ) acts on the coronary sinus, and/or ( 3) help distribute the concentrated end load L2 (FIG. 20) of the elongated body 157, 184 over a larger area of the coronary sinus so as to minimize damage to the host vessel, and/or (4) help It is used to limit the morphological changes of the vascular section in response to the load acting on the inner surface of the blood vessel, so as to ensure reliable blood flow and minimize vascular damage. It should be appreciated in this regard that the coronary sinus typically has different characteristics (eg, diameter, wall firmness, etc.) along its length, and that the stabilizing scaffold 210 can be accordingly designed to exhibit different characteristics along its length. As a non-limiting example, the stabilizing stent 210 may have a smaller diameter at its distal end and a larger diameter at its proximal end so as to correspond to the typical geometry of the coronary sinus. As another non-limiting example, the stabilizing stent 210 can be designed to provide greater support at the proximal end of the coronary sinus (where the veins are always relatively soft) and at the distal end of the coronary sinus (where the veins are relatively soft). always relatively strong) provide less support.

In one form of the invention in which the elongate body 157 is placed within the stabilizing stent 210 in the coronary sinus 30, the lead 103 is first advanced into the coronary sinus as described above. A stent deployment catheter 212 ( FIG. 38 ) with a stabilizing stent 210 is advanced along the guidewire 103 into the coronary sinus. When the stabilizing stent 210 is in the desired position in the coronary sinus, the bumper 214 straddling the guide wire 103 engages the stabilizing stent and the stent deployment catheter 212 is pulled back enough to deploy the stabilizing stent 210, followed by The bumpers 214 are removed together, leaving the stabilizing brace 210 and guidewire 103 in place in the coronary sinus 30 . The delivery catheter 106 is then passed along the guide wire 103 until the distal end of the catheter is in the coronary sinus and the stabilizing stent. Once the delivery catheter 106 is positioned in the coronary sinus and the stabilizing stent, the guide wire 103 can be removed. The pushrod 109 is then passed through the central lumen 136 of the delivery catheter 106 until the elongated body 157 is positioned near the posterior annulus of the mitral valve 36 and in the stabilizing bracket 210 . The delivery catheter 106 is then withdrawn so that the ribs 200 of the body engage the stabilizing bracket, the pushrod 109 is left in place and the elongated body 157 is locked in the stabilizing bracket 210 as described above.

In another form of the invention in which the elongated body 184 is placed within a stabilizing stent 210 in the coronary sinus, the lead 103 is advanced into the coronary sinus as described above. A stent deployment catheter 212 with a stabilizing stent 210 therein is mounted over the guide wire 103 and advanced into the coronary sinus 30 . The stabilizer 210 is then held in place by the buffer 214, and the stent deployment catheter 212 is pulled back enough to deploy the stabilizer 210, which is then withdrawn along with the buffer 214, leaving the lead 103 and the stabilizer 210 stays in place. Body 184 and push sleeve 187 are then pushed over lead 103 until elongated body 184 is disposed in stabilizing bracket 210 . The push sleeve 187 and guide wire 103 are then withdrawn together, leaving the elongated body 184 and stabilizing bracket 210 in place and locking the elongated body 184 in the stabilizing bracket.

Referring to Fig. 39, it can be seen that the maximum load (L1) acting on the elongated bodies 157, 184 and the stabilizing bracket 210 is located at the middle portion thereof, which reduces the displacement of the stabilizing bracket and thus the body 157 , 184 to the distal or proximal displacement.

Referring next to FIGS. 40 and 41 , it can also be seen that the elongated bodies 157 , 184 may have a diameter that is significantly smaller than the diameter of the stabilizing bracket 210 . In this case, the stabilizing bracket 210 may be provided with rails 211 for receiving the elongated bodies 157,184. By way of example, rail 211 comprises a hollow tube formed on the inner wall of stabilizing bracket 210 , and rail 211 is sized to receive elongate body 157 , 184 and secure it relative to stabilizing bracket 210 . If desired, the stabilizing bracket 210 may terminate shorter than the ends of the elongated bodies 157, 184, such as shown in Figs. 40, 41 . Alternatively, the stabilizing bracket 210 terminates synchronously with the ends of the elongated bodies 157, 184, such as in the manner shown in FIGS. For example in the manner shown in FIGS. 44 and 45 .

In a preferred method of using the stabilizing bracket 210 and the elongated body 157, 184 of FIGS. , which is similar to FIG. 38, except that the wire 103 is modified to be eccentric so as to extend through the guide rail 211 of the stabilizing bracket in the manner shown in FIG. 46. The stabilizing brace 210 is first configured in the manner described above, and the guide wire 103 is used to load the elongated bodies 157, 184 into place in the coronary sinus, including the rails 211 passing through the stabilizing brace.

Referring now to FIG. 47, in another configuration, the elongated bodies 157, 184 may be preloaded into the rails 211 of the stabilizing bracket when the stabilizing bracket is loaded into the bracket deployment guide 212; Both the stabilizing brace 210 and the elongated bodies 157, 184 are deployed in the coronary sinus.

As shown in FIG. 48, the elongated bodies 157, 184 may be formed as part of a stabilizing bracket 210, the combined stabilizing bracket portion being located at the mid-portion of the elongated bodies 157, 184 where the coronary sinus applies the greatest load L1, It is the load on the coronary sinus that is displaced by the treatment. Likewise, the stabilizing bracket 210 may terminate shorter than the ends of the elongated bodies 157, 184 (Fig. 48), or the stabilizing bracket 210 may terminate synchronously with the ends of the elongated bodies 157, 184 (Fig. beyond the ends of the long bodies 157, 184 (Fig. 50).

In another embodiment shown in FIGS. 51 and 52 , the combination of elongated body 157, 184 and stabilizing bracket 210 includes two or more bracket sections, such as sections 210A and 210B, wherein section 210A is disposed at the end of the combination. The middle portion, while portion 210B extends through portion 210A and protrudes from the end thereof, defines a more resilient end portion. The bodies 157, 184 are secured to a generally cylindrical frame portion 210A located in the middle portion of the bodies 157, 184, and to a semi-cylindrical frame end portion 210B. The middle part 210A is the strongest part of the combination of the elongated body and the stabilizing bracket, and it is the part used to carry the largest load L1.

An alternative embodiment is shown in Figures 53 and 54 in which a set of ribs 215 in the form of two rows of ribs are secured to the elongated body 157,184. As shown in Figure 54, the rows of ribs 215 are preferably offset from one another such that ribs on one side of the elongated body 157, 184 are not opposite ribs on the other side of the elongated body. This allows the rib 215 to bend towards the opposite side without engaging the opposing rib. The bending of the ribs allows the ribs to be compressed for placement in the catheter.

An alternative configuration similar to that of Fig. 54 is shown in Fig. 55, however showing ribs 215 connected to spines 216 which are hollow to receive elongate bodies 157, 184 therein.

An alternative combination of elongated body and bracket assembly is shown in Figure 56, where a stabilizing bracket 210 includes elongated body portions 157, 184 in the form of rods integral with the bracket. In the embodiment shown in Fig. 56, at least one body portion 157, 184 extends from one end of the assembly to the other, while the other body portion 157, 184 extends only to the middle of the assembly. Consequently, the end sections of the assembly are less rigid than their middle sections.

，这样，中间部分包括所有三个稳定支架210′，210＂和210

，刚好位于中间部分外侧的部分包括稳定支架210＂和210

，而末端部分只包括稳定支架210

。因此，本体157，184的中间部分对移动的抵抗性最大，而末端部分的抵抗性最小，稳定支架210＂的区域产生比中间部分更少的阻力，但其阻力大于末端部分。Referring to Fig. 57, it can be seen that the bodies 157, 184 only include stabilizing brackets, such as telescopically arranged stabilizing brackets 210', 210" and 210

, so that the middle part includes all three stabilizing brackets 210', 210" and 210

, the portion just outside the middle portion includes stabilizing brackets 210" and 210

, while the end part only includes the stabilizing bracket 210

. Thus, the middle portion of the body 157, 184 is most resistant to movement and the end portions are least resistant, the region of the stabilizing bracket 210" creating less resistance than the middle portion, but greater resistance than the end portions.

Referring next to Figures 58-60, alternative combinations of elongated body and bracket assemblies are shown, wherein the elongated body includes the five-region elongated body 157, 184 shown in Figures 23 and 24, and the bracket includes three The support brackets, each as shown in FIGS. 40-47 , have rails 211 for receiving the elongated bodies 157 , 184 . More specifically, the five-region elongated body 157, 184 includes a plurality of sections S ₁ , S ₂ and S ₃ , wherein section S ₁ is configured to have a selected degree of flexibility and section S ₂ is configured to have a greater flexibility than section S . ₁ to a lower degree of flexibility, while section _S3 is configured to have a higher degree of flexibility than section _S1 . Due to this configuration, section _S1 will carry the load to remodel the mitral annulus, section _S2 will transfer this load laterally to section _S3 , and section _S3 will spread this load laterally to the side wall of the coronary sinus superior. In a preferred form of the invention, portion S ₁ is configured to have a degree of flexibility that supports remodeling of the mitral annulus while allowing portion S ₁ to engage with the mitral annulus at the commissure point. roughly coincides with the arc of curvature; section _S2 is configured to have a sufficiently low degree of flexibility that substantially all of the loads caused by the remodeling of the mitral annulus will be transferred to section _S3 ; and section _S2 has sufficient The length is long so that a backward force acting on the wall of the coronary sinus (eg, indicated by arrow P in FIG. 7 ) will be exerted in the area of the valve commissures. The supporting brackets 210 are positioned in the coronary sinus 30 such that one bracket 210 accommodates a portion S ₁ , one bracket 210 accommodates a portion S ₂ , and one bracket 210 accommodates another portion S ₃ . The elongate bodies 157, 184 may be deployed at the same time as the support bracket 210, or after the support bracket 210 is deployed. Section _S3 is preferably slidable on stent rail 211, especially if elongate body 157, 184 is designed to achieve gradual tissue remodeling over an extended period of time. Among other things, this configuration is shaped to center itself naturally in the region around the posterior leaflet and to conform well to the curvature of the posterior leaflet. If desired, such "five-region" elongated bodies may be formed from one material with different diameters used to form different body regions.

It should also be understood that the bracket 210 has a stretched configuration, or a ribbed configuration as shown in FIGS. 53 and 54 .

Referring next to Figures 61-63, there is shown an elongated body and bracket assembly combination similar to that shown in Figures 58-60, except that rails 211 extend between each bracket region so A single stent structure is formed having three regions that engage the wall of the coronary sinus.

As such, different stabilizing bracket configurations may be provided to prevent displacement of the generally flat and generally rigid elongated body, as well as various body and stabilizing bracket combinations may be provided to similarly prevent or mitigate such displacement.

It should be understood that the present invention is in no way limited to the specific constructions disclosed herein and/or shown in the drawings, but includes all modifications or equivalent constructions within the scope of the claims.

Claims (21)

1. device that is used to reduce mitral incompetence comprises:

Body with far-end, near-end and mid portion; When said body configuration becomes near the coronary sinus said body is positioned at mitral rear portion lobule; Said far-end and near-end apply active force backward to the wall of coronary sinus; And said mid portion applies active force forward to the wall of coronary sinus, so that said mitral rear portion ring body is moved forward, engages thereby improve lobule;

Said body is included in the rod member that has flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint;

Said body comprises a central area, two zone lines and two perimeters; Wherein, Said two zone lines lay respectively between a said central area and said two perimeters; Said central area is constructed with the flexibility of selected degree, and said zone line is constructed with than the said central area flexibility of low degree more, and said perimeter is constructed with the flexibility than said central area higher degree.

2. device according to claim 1 is characterized in that said device also comprises the center rest that links to each other with said rod member.

3. device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the roughly straight slender body near the coronary sinus of the mitral rear portion of patient lobule; The length of said roughly straight slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when said roughly straight slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure; So that increase the radius of curvature of Bicuspid valve ring body, it is moved forward, engage thereby improve lobule;

Said body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint;

Said body comprises a central area, two zone lines and two perimeters; Wherein, Said two zone lines lay respectively between a said central area and said two perimeters; Said central area is constructed with the flexibility of selected degree, and said zone line is constructed with than the said central area flexibility of low degree more, and said perimeter is constructed with the flexibility than said central area higher degree.

4. device according to claim 3; It is characterized in that; Said roughly straight slender body is roughly straight before in being inserted into patient, and after in being inserted into patient because of and anatomical structure between passive type elastic interaction but general curved.

5. device according to claim 3 is characterized in that said device comprises the center rest that is connected on the said rod member.

6. device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the roughly inflexible slender body near the coronary sinus of the mitral rear portion of patient lobule; Said roughly inflexible slender body is constructed with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when said roughly inflexible slender body is positioned in the coronary sinus; It causes at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate various structure, so that the rear portion ring body is moved forward, engages thereby improve lobule;

Said body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body is moved forward, and improve the lobule joint;

Said body comprises a central area, two zone lines and two perimeters; Wherein, Said two zone lines lay respectively between a said central area and said two perimeters; Said central area is constructed with the flexibility of selected degree, and said zone line is constructed with than the said central area flexibility of low degree more, and said perimeter is constructed with the flexibility than said central area higher degree.

7. device according to claim 6 is characterized in that the rigidity of said roughly inflexible slender body is higher than the anatomical tissue that is between device and the Bicuspid valve, but still is flexible.

8. device according to claim 6 is characterized in that said device comprises the center rest that is connected on the said rod member.

9. device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the roughly straight and roughly inflexible slender body near the coronary sinus of the mitral rear portion of patient lobule; Said length roughly straight and roughly inflexible slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of said Bicuspid valve rear portion; Make when said roughly straight and roughly inflexible slender body is positioned in the coronary sinus; It causes at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure; So that increase the radius of curvature of Bicuspid valve ring body, it is moved forward, engage thereby improve lobule;

Said body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body is moved forward, and improve the lobule joint;

Said body comprises a central area, two zone lines and two perimeters; Wherein, Said two zone lines lay respectively between a said central area and said two perimeters; Said central area is constructed with the flexibility of selected degree, and said zone line is constructed with than the said central area flexibility of low degree more, and said perimeter is constructed with the flexibility than said central area higher degree.

10. device according to claim 9 is characterized in that, said slender body is roughly straight in being inserted into patient before, and is general curved after in being inserted into patient.

11. device according to claim 9 is characterized in that, the rigidity of said roughly inflexible slender body is higher than the anatomical structure that is between device and the Bicuspid valve, but still is flexible.

12. device according to claim 9 is characterized in that, said device comprises the center rest that is connected on the said rod member.

13. device according to claim 9; It is characterized in that; Said device also comprises and is suitable for being positioned at the delivery conduit in patient's coronary sinus; Said delivery conduit is formed by flexible material, makes its structure that will roughly demonstrate coronary sinus, and said delivery conduit is suitable for accepting therein said straight and roughly inflexible slender body.

14. device according to claim 13; It is characterized in that; Said straight and roughly inflexible slender body is installed on the rod member; Said rod member is formed by flexible material, make said rod member will demonstrate the structure of coronary sinus, and the size of said rod member is adapted to be mounted within the said delivery conduit.

15. device according to claim 13 is characterized in that, said device also comprises the lead removed that is used for said delivery conduit is positioned at coronary sinus.

16. device according to claim 9; It is characterized in that; Said device also comprises the lead that is suitable for being positioned in the coronary sinus, and said lead is formed by flexible material, makes it will roughly demonstrate the structure of coronary sinus; And said straight and roughly inflexible slender body is a hollow, so that be enclosed within on the said lead.

17. device according to claim 9; It is characterized in that; Said far-end straight and roughly inflexible slender body and at least one in the near-end comprise flexible portion, are used for when said straight and roughly inflexible slender body is arranged on coronary sinus, alleviating the stress that is applied on the coronary sinus.

18. device according to claim 9; It is characterized in that; Said far-end straight and roughly inflexible slender body and in the near-end at least one are tapered, are used for when said straight and roughly inflexible slender body is arranged on coronary sinus, alleviating the stress that is applied on the coronary sinus.

19. device according to claim 9 is characterized in that, said straight and roughly inflexible slender body has the length that is no more than the coronary sinus part that is between coronary ostium and the AIV.

20. device according to claim 13 is characterized in that, said device also comprises supporting tube, is used for when said straight and roughly inflexible slender body passes said delivery conduit, preventing that said delivery conduit from redirecting to postcava.

21. a device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the slender body near the coronary sinus of patient's Bicuspid valve rear portion lobule; Said device is suitable for transforming near the intrinsic curvature of at least a portion coronary sinus of Bicuspid valve rear portion lobule; So that said rear portion ring body is moved forward; Engage thereby improve lobule, wherein said device is included in rod member that has flat construction under the unstress state and the center rest that links to each other with said rod member;

Said body comprises a central area, two zone lines and two perimeters; Wherein, Said two zone lines lay respectively between a said central area and said two perimeters; Said central area is constructed with the flexibility of selected degree, and said zone line is constructed with than the said central area flexibility of low degree more, and said perimeter is constructed with the flexibility than said central area higher degree.

Images