JP2008521501A - Method and apparatus for improving mitral valve function - Google Patents

Abstract

A method and apparatus for reducing mitral regurgitation. The device (90) is inserted in the patient's coronary sinus (90) in the vicinity of the mitral posterior leaflet. This device brings the original curved shape of at least the portion of the coronary sinus in the vicinity of the mitral posterior leaflet closer to a straight shape, thereby moving the annulus of the posterior leaflet forward, thereby bringing the valve leaflet into a joint state. It improves and reduces mitral regurgitation. The apparatus is further configured for use with an electrical lead (600), such as an implantable biventricular pacing device, an implantable defibrillator, and the like. Electrical lead wire for
[Selection] Figure 1

Description

The patent application is
(1) United States Patent Application No. 10 / 446,470, a pending prior patent application (filing date: May 27, 2003, inventor: Jonathan Rourke et al., Title of invention: METHOD AND APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION, agent reference number: VIA-43)
(2) United States Patent Application No. 10 / 894,676, pending prior patent application (Filing date: July 19, 2004, Inventor: Jonathan Rourke et al., Title of invention: METHOD AND APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION, agent serial number: VIA-48)
(3) US Provisional Patent Application No. 60 / 630,606, pending prior application (Filing date: November 24, 2004, Inventor: Jonathan Rourke et al., Title of invention: METHOD AND APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION, agent reference number: VIA-49 PROV).
The contents of the above three US patent applications are incorporated herein by reference.

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

  The mitral valve is located in the heart between the left atrium and the left ventricle. A normally functioning mitral valve causes blood to flow from the left atrium into the left ventricle when the left ventricle dilates (ie, diastole), and when the left ventricle contracts (ie, systole). Blocks backflow of blood from the left ventricle into the left atrium.

  Under certain circumstances, regurgitation may occur because the mitral valve does not function properly. For example, patients with heart failure often have mitral regurgitation. The occurrence of mitral regurgitation in heart failure patients is due to deformation of the left ventricle, papillary muscles, and mitral annulus. When they are deformed, the result is mitral valve leaflet joint failure during systole. Under these circumstances, in order to remove mitral regurgitation, mitral annuloplasty is generally performed, and the periphery of the expanded annulus is sewn, The method of restoring the original shape of the mitral annulus is adopted.

  More specifically, currently performed surgery to repair the mitral valve generally opens the left atrium, sutures, and more commonly to reduce the diameter of the mitral annulus. Specifically, it is necessary to sew the suture thread and the support ring to the inner peripheral surface of the annulus. This sewing structure reduces the diameter of the annulus by tightening the annulus in a form that tightens the mouth of the drawstring bag, thereby improving the joint state of the valve leaflets, and thus the mitral valve It reduces backflow.

  The method of repairing the mitral valve in this way is generally called “mitral valvuloplasty”, which can effectively reduce mitral regurgitation in patients with heart failure. And it can relieve the symptoms of heart failure, improve the quality of life and prolong life. However, this mitral valve surgery is an invasive procedure (ie, general anesthesia, thoracotomy, cardiopulmonary bypass, cardiopulmonary arrest, incision of the heart itself to access the mitral valve, etc.) Because of the risks involved, many patients with heart failure cannot be a good candy date for this surgery. Thus, for heart failure patients, if this provides a less invasive means to improve the valve leaflet junction and reduce mitral regurgitation, this method of treatment is thereby applied to more patients. It becomes possible to adapt.

  Furthermore, mitral regurgitation occurs in about 20% of patients with acute myocardial infarction. Mitral regurgitation is also a major cause of cardiogenic shock in approximately 10% of patients with severe hemodynamic instability due to acute myocardial infarction. Patients who develop mitral regurgitation and lead to cardiogenic shock account for approximately 50% of hospital deaths. Therefore, it is very beneficial for such patients to eliminate mitral regurgitation. However, patients with acute myocardial infarction complicated by acute mitral regurgitation fall into the high-risk category of surgical candy dates, and are therefore suitable for conventional mitral angioplasty. It's not a candy date. Therefore, for patients with such life-threatening symptoms, if they provide a minimally invasive means that can temporarily reduce or eliminate their mitral regurgitation, then Give patients time to recover from acute life-threatening events, such as infarctions, and thus make them suitable candydates for other interventional medical or surgical treatments .

  Accordingly, one object of the present invention is to provide an improved method for reducing mitral regurgitation.

  Another object of the present invention is to provide an improved device for reducing mitral regurgitation.

  These and other objects are achieved by the present invention. The present invention encompasses an improved method for reducing mitral regurgitation and an improved apparatus for reducing mitral regurgitation.

According to the present invention, in one embodiment thereof, an assembly for reducing mitral regurgitation is provided, the assembly comprising:
An elongate carrier member having a first shape generally along the shape of the coronary sinus when inserted into the coronary sinus and more linear than the first shape The elongated carrier member is made of a material having a sufficiently large flexibility so as to exhibit a second shape that is a shape that is closer to a linear shape when biased so as to have a shape close to Has a plurality of lumens extending through its longitudinal direction,
A plurality of linearity enhancing rods insertable into the lumen, each of the plurality of linearity enhancing rods,
(1) It has greater rigidity than that of the living tissue around the mitral posterior leaflet,
(2) the coronary sinus has a shape that is closer to a straight line than the shape of the portion near the posterior leaflet of the mitral valve; and
(3) having an appropriate length relative to the radius of curvature of the coronary sinus;
If the linearity enhancing rod is inserted into the lumen with the carrier member positioned near the mitral posterior leaflet in the patient's coronary sinus, the insertion The straightness enhancing rod acts on the wall of the coronary sinus to move the annulus of the mitral posterior leaflet forward, thereby improving the joint state of the leaflet. Mitral regurgitation is reduced,
At least one lumen of the plurality of lumens is dimensioned to allow insertion of an electrical lead.
An assembly characterized by this.

According to the present invention, as another embodiment thereof, a method for reducing mitral regurgitation is provided, which comprises:
Preparing a flexible carrier member in which a plurality of lumens extending through the longitudinal direction are formed;
An electrical lead is inserted through the patient's vasculature to place the distal end of the electrical lead into the patient's coronary sinus and a guidewire is inserted through the patient's vasculature to guide the guide Place the distal end of the wire into the patient's coronary sinus,
Inserting the carrier member along the outer circumference of the electrical lead and the guide wire to place the distal end of the carrier member into the coronary sinus of the patient;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
It is the method characterized by this.

According to the present invention, as another embodiment thereof, a method for reducing mitral regurgitation is provided, which comprises:
Preparing a flexible carrier member in which a plurality of lumens extending through the longitudinal direction are formed;
Inserting an electrical lead through the patient's vasculature and placing the distal end of the electrical lead into the patient's coronary sinus;
Inserting the carrier member along the outer periphery of the electrical lead and placing the distal end of the carrier member into the coronary sinus of the patient;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
It is the method characterized by this.

According to the present invention, as another embodiment thereof, a method for reducing mitral regurgitation is provided, which comprises:
Preparing a flexible carrier member in which a plurality of lumens extending through the longitudinal direction are formed;
Inserting the carrier member through the patient's vasculature and placing the distal end of the carrier member into the patient's coronary sinus;
Inserting an electrical lead through the carrier member to place the distal end of the electrical lead into the patient's coronary sinus;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
It is the method characterized by this.

According to the present invention, as another embodiment thereof, a method for reducing mitral regurgitation is provided, which comprises:
A plurality of lumens extending through in the longitudinal direction are formed, and a flexible carrier member having an electrical lead inserted through the lumen is prepared.
Inserting the carrier member through the patient's vasculature to place the distal end of the carrier member into the coronary sinus of the patient and localizing the electrical lead to the biological tissue of the heart;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
It is the method characterized by this.

  Various preferred embodiments of the present invention will now be described in more detail with reference to the accompanying drawings, so that the above and other objects of the present invention and the above features and other aspects of the present invention will be described. Let's clarify the characteristics of. In the accompanying drawings, the same or corresponding components are denoted by the same reference numerals.

Overview The coronary sinus is the largest of the veins in the human heart wall. A substantial portion of the coronary sinus that passes through the coronary sulcus runs along the left ventricle, and the length of that portion is typically about 5-10 cm. What is important here is that some part of the entire coronary sinus, typically 7-9 cm, for example, runs very close to the trailing edge of the mitral annulus. . The present invention takes advantage of this fact. More specifically, a novel device is placed near the mitral posterior leaflet in the coronary sinus to change the original curved shape of the portion of the coronary sinus near the mitral posterior leaflet. Thus, the posterior leaflet ring portion is moved forward to improve the joint state of the leaflet, thereby reducing the mitral valve regurgitation.

Patient's Body Structure FIGS. 1 and 2 show each part of the patient's cardiovascular system 5. More specifically, the entire cardiovascular system 5 includes the heart 10, the superior vena cava 15, the right subclavian vein 20, the left subclavian vein 25, the jugular vein 30, and the inferior vena cava 35. The superior vena cava 15 and the inferior vena cava 35 are connected to the right atrium 40. The coronary ostium 45 continues to the coronary sinus 50. At the distal end 55 (FIG. 2) of the coronary sinus 50, the above vasculature is connected to the descending interventricular vein (AIV) 60 (FIGS. 1 and 2). In the context of the present invention, for convenience, the term “coronary sinus” refers to a blood vessel structure extending between the coronary ostium 45 and the AIV 60.

  As shown in FIG. 2, a coronary sinus 50 extends between the coronary ostium 45 and the AIV 60, and this coronary sinus 50 is quite close to the trailing edge of the annulus 65 of the mitral valve 70. is doing. The mitral valve 70 includes a posterior leaflet 75 and an anterior leaflet 80. In a mitral valve that generates a backflow, normally, the posterior leaflet 75 and the anterior leaflet 80 are not properly joined in the systole, and thus a gap 85 is formed between them. It is a cause to generate.

Overview of Mitral Valvuloplasty Device FIGS. 3 and 4 show a mitral valvuloplasty device 90 according to one preferred embodiment of the present invention. The mitral annuloplasty device 90 includes an implant member 95 (FIG. 4) for remodeling the mitral annulus for therapeutic purposes (FIG. 4), and for delivering the implant member 95 to the treatment site. A catheter shaft 100. In one preferred configuration, the implant member 95 and the catheter shaft 100 are integrated into a single structure. Examples of a method for inserting the mitral valvuloplasty device 90 into the coronary sinus of a patient include a method of inserting using a standard introduction sheath 105 (FIG. 3) and a guide wire 110. is there.

Implant Member As shown in FIGS. 3-6, in one embodiment of the present invention, the implant member 95 is constructed with a lead section 115 and a treatment section 120. .

  The lead section 115 has a distal end 125 and a proximal end 130. The lead section 115 is tapered over its entire length, the tip is thin, and the diameter increases toward the proximal end. Providing such a tapered lead section 115 facilitates moving the implant member 95 distally through the vasculature. The lead section 115 is formed with at least one lumen 135 (FIG. 5) extending from the distal end to the proximal end. By providing such a lumen 135, the mitral valvuloplasty device can be delivered by a standard percutaneous delivery system using a guide wire 110, which will be described in more detail later. To do.

  As a material for producing the lead section 115, it is preferable to use a material having relatively high flexibility and flexibility, such as a low hardness silicone rubber, and the size of the lead section 115 is determined based on the proximal end portion 130 thereof. However, when the coronary sinus is located at the connection site between the coronary sinus and the anterior chamber (AIV), it is preferable that the end portion 125 enters the AIV and faces downward. . It is further preferred that one or more radiopaque markers 140 (FIGS. 3 and 4) be attached to or near the distal end 125 of the lead section 115 so that the end 125 The position can be visually confirmed with a fluoroscope or the like.

  The treatment section 120 is constituted by a carrier member 145, which has a distal end 150 and a proximal end 155. The distal end 150 of the carrier member 145 is coupled to the proximal end 130 of the lead section 115 and includes this lead section 115 to pass through the vasculature and the mitral valvuloplasty device 90. The treatment section 120 can be inserted relatively easily and without damaging living tissue. In one preferred configuration, the lead section 115 and the treatment section 120 are integrated into a single structure. Still further, one or more radiopaque markers 160 (FIGS. 3 and 4) are attached at or near the distal end 150 of the treatment section 120 and at or near the proximal end 155 of the treatment section 120. One or more radiopaque markers 165 are preferably attached so that the location of the treatment section 120 can be viewed with a fluoroscope or the like.

  The carrier member 145 is formed with at least one and preferably a plurality of main function lumens 170 (FIG. 6) extending from the proximal end 155 toward the distal end 150. When a plurality of main function lumens 170 are formed, all of the main function lumens may have the same diameter or may have different diameters. In one preferred configuration, three main function lumens 170 of the same diameter are formed at equiangular intervals around the central axis of the carrier member 145 so that the main function lumens 170 are proximal to the carrier member 145. It extends substantially over the entire length from the portion 155 to the end portion 150.

  In one preferred configuration, the carrier member 145 further includes at least one and preferably a plurality of auxiliary lumens 175 (FIG. 6) extending from its proximal end 155 toward the distal end 150. It is supposed to be formed. When a plurality of auxiliary lumens 175 are formed, all of the auxiliary lumens may have the same diameter or may have different diameters. Further, one or several auxiliary lumens 175 may have the same diameter as one or several main function lumens 170. In one preferred configuration, three auxiliary lumens 175 of the same diameter are formed at equiangular intervals around the central axis of the carrier member 145 so that the auxiliary lumens 175 are at the proximal end of the carrier member 145. It extends over almost the entire length from 155 to the end portion 150.

  At least one primary functional lumen 170 and / or at least one auxiliary lumen 175 connects to the at least one lumen 135 (FIG. 5) described above that extends through the lead section 115. I am doing so. This allows delivery of the device for mitral valvuloplasty by a standard percutaneous delivery system using guidewire 110, which will be described in more detail later. In one preferred configuration, one of the plurality of main functional lumens 170 of the carrier member 145 is connected to a single lumen 135 that extends through the lead section 115. ing.

  The material for producing the carrier member 145 is preferably a material having a relatively high flexibility, so that the biological member is damaged when the carrier member 145 is inserted into the coronary sinus of the patient. The risk is relatively small, and the coronary sinus can be inserted without significantly changing its original shape, which will be described in more detail later. The carrier member 145 is preferably made of a material with relatively little friction, so that the carrier member 145 can be easily advanced through the patient's vasculature (eg, a guide). It is easy to move along the outer circumference of the wire), and it is easy to insert and remove rods and wires into the lumens 170 and 175 of the carrier member 145. In one preferable configuration example, the carrier member 145 is formed of Teflon (trademark).

  The main function lumen 170 is a lumen for re-modeling the mitral annulus by selectively inserting a linearity enhancing rod therein, which will be described in more detail later. One specific example of a linearity enhancing rod is shown as a linearity enhancing rod 180 in FIG.

As shown in FIGS. 3, 7, and 14, each of the plurality of linearity enhancing rods 180 is
(1) It has somewhat greater rigidity than the living tissue surrounding the mitral posterior leaflet,
(2) having a shape somewhat close to a straight line compared to the shape of the portion of the coronary sinus near the mitral posterior leaflet; and
(3) having an appropriate length relative to the radius of curvature of the coronary sinus;
If the linearity enhancing rod 180 is inserted into the main function lumen 170 with the carrier member positioned near the mitral posterior leaflet in the patient's coronary sinus, The inserted linearity enhancing rod exerts a linearity enhancing force on the wall of the coronary sinus, thereby moving the annulus of the mitral posterior leaflet forward, thereby improving the joint state of the valve leaflet, Therefore, mitral regurgitation is reduced. This will be described in detail later.

  In other words, the dimensions and linearity of each of the linearity enhancing rods 180 are linear with respect to the coronary sinus to accommodate the linearity enhancing rod 180 in the curved coronary sinus. The linearity enhancing rod 180 has a dimension and linearity so that one or both of the shape of the linearity enhancing rod 180 must change, and the rigidity of the linearity enhancing rod 180 is a biological tissue facing the linearity enhancing rod 180. Because the stiffness of the linearity enhancement rod is placed in the coronary sinus, it causes a change in the shape of the biological tissue, thereby correcting the shape of the mitral valve, Therefore, mitral regurgitation is reduced. This will be described in detail later.

  In one preferred embodiment of the present invention, each of the plurality of linearity enhancing rods 180 is composed of a rod-like member having a substantially linear shape (when no stress is applied). The rod-like member has some flexibility, and due to its elasticity, a linearity enhancing force (force that brings the shape of the living tissue closer to a linear shape) acts on the wall surface of the coronary sinus.

  The plurality of linearity enhancing rods 180 may have the same linearity enhancing force acting on the wall surface of the coronary sinus every other line, or the plurality of linearity enhancing rods. May be configured so as to apply linearity enhancing forces of different magnitudes to each other. In one preferred embodiment of the present invention, a plurality of linearity-enhancing rods 180 that generate different linearity-enhancing forces are provided as a kit, and a doctor selects an appropriate one of them. Can be selected. As a method of varying the linearity enhancing force of each of the plurality of linearity enhancing rods, a method of varying the rod rigidity (for example, varying the rod material or the rod diameter), the rod Different lengths, when using multiple linearity-enhancing rods, the relative position of the rods is different (eg when using multiple rods their longitudinal positions are relative There is a method to make it different.

  Further, in one preferred embodiment of the present invention, the magnitude of the force that each linearity enhancing rod 180 exerts on the wall of the coronary sinus is ultimately required to reduce mitral regurgitation. The magnitude of the force required to move the mitral valve annulus by a movement amount corresponding to a part of the target total movement amount. In this embodiment of the present invention, the linearity enhancing force acting on the mitral annulus can be increased by inserting a further linearity enhancing rod 180 inside the carrier member 145, and / or Increasing the linearity enhancing force acting on the mitral annulus by inserting additional linearity enhancing rods into one or more auxiliary lumens 175 and / or the carrier member 145 A linearity-enhancing force that acts on the mitral annulus by equipping it with a further linearity-enhancing member that is embedded inside, formed on its outer peripheral surface, or fitted on its outer periphery. It can be larger. As a specific example, of course, the present invention is not limited to this. However, a further linearity enhancing rod is embedded in a region around the main function lumen 170 and the auxiliary lumen 175 of the body of the carrier member 145. Alternatively, and / or a linearity enhancing member as an external member in the form of a plate-like member, a shell-like member, or a tubular member may be provided on the outer peripheral surface of the carrier member 145.

  As yet another method, the device may be configured to apply an elastic linearity enhancing force to the mitral annulus, and in such a case, when the linearity enhancing force is first applied. The mitral annulus movement caused thereby is only a movement amount corresponding to a portion of the overall target movement required to alleviate mitral regurgitation, but the coronary sinus The linearity enhancing force continues to exert a therapeutic effect dynamically over a period in which remodeling (shape change) proceeds.

  In one preferred embodiment of the present invention, each of the linearity enhancing rods 180 is configured as a multi-zone bar having a plurality of regions with different flexibility sizes. As a result, the respective parts of the mitral annulus are deformed with different forces, thereby improving the joint state of the leaflets.

In one particularly preferred embodiment of the present invention, each of the linearity enhancing rods 180 is comprised of U.S. Patent Application No. 10 / 446,470, U.S. Patent Application No. 10 / 894,676, referenced at the beginning of this specification, It is constituted by a “5-zone bar” disclosed in US Provisional Patent Application No. 60 / 630,606. As shown in FIG. 7, the linearity enhancing rod 180 includes a central part (hinge part) S ₁ having flexibility of a predetermined size and an extension part (flexibility smaller than the central part S ₁ ). an arm portion), end having a greater flexibility than the central portion S ₁ (foot portion) and a S _3. Basically, in this five-zone configuration, the central portion S ₁ functions as a “saddle portion” that engages the mitral annulus portion, and the arm portion S ₂ has a predetermined distance from the central portion S _1. It functions as a rigid structure part that transmits force to the outer surface of the coronary sinus at a distance (distance taken in the longitudinal axis direction of the coronary sinus), and the foot part S ₃ acts on the wall surface of the coronary sinus. It is designed to perform the function of “soft landing” the load. This five-zone bar has been found to be a very advantageous configuration because (1) the five-zone bar, when inserted into the coronary sinus, is centered on the monk. It has a centering property that attempts to match the position of the posterior leaflet of the cap valve, which is a kind of “macroelastic energy well”, which may cause the bar to move longitudinally (2) The 5-zone bar improves the joint state of the leaflets by reducing the anteroposterior distance of the expanded mitral valve without increasing the intercommissural distance Therefore, the possibility of generating an inconvenient “lateral jet” is extremely low, and (3) the five-zone bar can cope with anatomical variations from patient to patient perfectly. Due to .

Still further, the linearity enhancing rod 180 includes a tapered end portion 185 (FIG. 7), and a ball-shaped tip for preventing the distal end portion 183 from damaging living tissue at the distal end thereof. Preferably 190 is formed. By doing so, the linearity enhancing rod 180 is easily inserted into the main functional lumen 170 of the carrier member 145 from outside the patient body with the carrier member 145 disposed in the coronary sinus of the patient. be able to. Further, with the above-described configuration, the linearity enhancing rod 180 has a tip portion S ₄ having a greater flexibility than the above-described end portion S ₃ .

It may be desirable for one or several of the plurality of linearity enhancing rods 180 to be used to be an integrally molded part of a single material (eg, Nitinol). In this case, in order to make the flexibility of the plurality of regions S ₁ , S ₂ , S ₃ , and S ₄ different, the rod diameters may be made different (see, for example, the configuration shown in FIG. 8). I want to be) Further, it may be desirable that one or several of the plurality of linearity enhancing rods 180 to be used have a composite structure in which two or more materials (for example, stainless steel and nitinol) are combined. In that case, the linearity enhancing rod may be configured by alternately arranging nitinol and stainless steel (see, for example, the configuration shown in FIG. 9), and concentrating nitinol and stainless steel. The arrangement may be a general arrangement (see, for example, the arrangement shown in FIG. 10 and FIG. 10A), and may be another arrangement.

Catheter Shaft Catheter shaft 100 (FIG. 4) is for delivering the implant member 95 to the treatment site. Catheter shaft 100 has a distal end 195 and a proximal end 200. When the catheter shaft 100 is delivering the implant member 95 to the treatment site, the distal end 195 of the catheter shaft 100 is engaged with the proximal end 155 of the implant member 95. In one embodiment of the present invention, the catheter shaft 100 is selectively separable from the proximal end 155 of the implant member 95, so that, for example, delivery of the implant member 95 to a treatment site. So that it can be separated at an appropriate time after completion. In order to make this possible, the implant member 95 is formed separately from the catheter shaft 100 and is detachably attached to the catheter shaft 100, as will be described in detail later. . In another embodiment of the present invention, the implant member 95 is formed integrally with the catheter shaft 100 so that it can be selectively separated from the catheter shaft 100 (eg, by cutting). ing. In yet another embodiment of the present invention, the implant member 95 and the catheter shaft 100 are formed as a single structure and maintained in that state during use.

  The catheter shaft 100 is an elongated structure that is sufficiently long to allow the implant member 95 to be inserted through the patient's vasculature and into the coronary sinus. And has a sufficiently large flexibility. For example, of course, but not limited to this, the length and flexibility of the catheter shaft 100 can be used to access the jugular vein in the cervix. The implant member 95 introduced into the body from the point or from the access point of the right subclavian vein or the left subclavian vein in the trunk is advanced downward through the access vein, and from there to the superior vena cava It is long and flexible so that it can be advanced further down through the right atrium and inserted into the coronary sinus.

  As shown in FIGS. 4 and 11, the catheter shaft 100 is configured with at least one and preferably multiple main function lumens 205. The main functional lumen 205 opens into the distal end 195 of the catheter shaft 100, extends through the entire length of the catheter shaft 100, and extends to the proximal end 200 of the catheter shaft 100. It is open. The main function lumen 205 provides access to the main function lumen 170 of the carrier member 145, and for this purpose, the plurality of main function lumens 205 of the catheter shaft 100 is provided with a plurality of carrier members 145. It is preferable that the number of the main function lumens 170 of the book is the same and the positions thereof are also aligned.

  In one preferred configuration, the catheter shaft 100 is further configured with at least one, and preferably multiple, auxiliary lumens 210. The auxiliary lumen 210 opens at the distal end 195 of the catheter shaft 100, extends through the entire length of the catheter shaft 100, and opens at the proximal end 200 of the catheter shaft 100. is doing. The auxiliary lumen 210 provides access to the auxiliary lumen 175 of the carrier member 145, and for this purpose, the multiple auxiliary lumens 210 of the catheter shaft 100 are the multiple auxiliary lumens of the carrier member 145. It is preferable that the number of lumens 175 is the same and the positions thereof are also aligned.

Usage Preferred usage of the mitral valve device 90 is as follows.

  First, a standard introducer sheath 105 (FIG. 3) is inserted into the patient's vasculature and advanced to the coronary vein. More specifically, of course, but not limited to, inserting the standard introducer sheath into the patient's carotid artery (or the patient's right or left subclavian vein). Advance through the superior vena cava and then pass through the right atrium and insert into the coronary ostium. Next, a guide wire 110 is inserted through the standard introduction sheath 105, and the guide wire 110 is inserted into the coronary sinus (FIG. 12). Next, the device 90 for mitral valvuloplasty is attached to the outer periphery of the guide wire 110. When the mitral valvuloplasty device 90 is formed by integrally forming the implant member 95 and the catheter shaft 100, the mitral valvuloplasty device 90 as a unit of the guide wire 110 is used. It will be attached to the outer periphery. On the other hand, when the device 90 for mitral valvuloplasty is a device in which the implant member 95 and the catheter shaft 100 are formed separately, after the implant member 95 and the catheter shaft 100 are combined, The combined member may be attached to the outer periphery of the guide wire 110. Alternatively, after the implant member 95 and the catheter shaft 100 are individually attached to the outer periphery of the guide wire 110, they are connected to each other. You may make it do. At any point in time when the implant member 95 and the catheter shaft 100 are integrated (ie, at the time of manufacture, before being attached to the outer periphery of the guide wire 110, or attached to the outer periphery of the guide wire 110) Regardless of the later time), the implant member 95 and the catheter shaft 100 are integrated, with the main functional lumen 170 of the carrier member 145 and the main functional lumen 205 of the catheter shaft 100 aligned. In addition, the auxiliary lumen 175 of the carrier member 145 and the auxiliary lumen 210 of the catheter shaft 100 are aligned. When the mitral valvuloplasty device 90 is attached to the outer periphery of the guide wire 110, the proximal end portion of the guide wire 110 is inserted into the main function lumen 170 and the main function lumen 205 aligned with each other. Preferably, the mitral valvuloplasty device 90 is advanced distally along the outer circumference of the guidewire 110 once the attachment is complete. Alternatively, however, when the mitral annuloplasty device 90 is attached to the outer periphery of the guidewire 110, the proximal end of the guidewire 110 is inserted into the auxiliary lumen 175 and the auxiliary lumen 210 that are aligned with each other. Again, once this is done, the mitral valvuloplasty device 90 is advanced distally along the outer circumference of the guidewire 110, or alternatively, the mitral valve Still another lumen for attaching the plastic surgery device 90 to the outer periphery of the guide wire may be formed in the mitral valve surgery device 90.

  Then, if the mitral valvuloplasty device 90 is advanced distally along the guidewire 110, i.e., downward, and the treatment section 120 is positioned near the mitral posterior leaflet, The lead section 115 enters the AIV and faces downward, and the junction between the treatment section 120 and the lead section 115 is located at the connection point between the coronary sinus and the AIV ( 3 and 13). Note that the radiopaque markers 140, 160, and / or 165 may be used to localize the mitral valve device 90 while observing with a fluoroscope or the like. Localization can be performed.

  When the mitral valve device 90 is inserted into the coronary sinus, which is the treatment site, the linearity enhancing rod 180 should not be inserted into the main functional lumen 170 of the treatment section 120. It is desirable to make it. Then, as the mitral valvuloplasty device 90 is advanced through the patient's vasculature, the carrier member 145 is more flexible so that the mitral valvuloplasty device 90 can be inserted more easily. It can be done easily. This is one of the important advantages of the present invention because it greatly reduces the risk of damaging living tissue and also reduces the risk of kinking in the mitral valvuloplasty device. This is because the device for mitral valvuloplasty can be inserted.

  Key features not used prior to insertion of the mitral valvuloplasty device 90 along the guidewire 110 because the carrier member 145 is made of a relatively flexible material. It may be desirable to load the lumen pair 170, 205 with an occlusive filler. If the unused main function lumen is left hollow, the lumen may be crushed especially when the carrier member 145 is bent. Such a situation can be prevented. In addition, if the unused main function lumen is left hollow, when the linearity enhancing rod is inserted into the carrier member later, the linearity enhancing rod may break through the side wall of the carrier member. Such a situation can be prevented by loading the filler. For example, when the carrier member 145 has three main function lumens 170, the filling filler loaded in the two main function lumens 170 out of the three main function lumens 170 is the remaining (third) main function lumen. It functions as a “rail” that guides the linearity enhancing rod that is inserted into the functional lumen. In this regard, however, it is preferred that such an occlusive filler be as flexible as possible, so that the mitral valvuloplasty device bends and / or mitral valvuloplasty. It is possible to prevent the unused main function lumen pairs 170 and 205 from being crushed without generating a large resistance to the insertion of the device for use.

  Similarly, the auxiliary lumen pair 175, 210 may be replaced with an unused auxiliary lumen pair 175, 210 prior to insertion of the mitral valvuloplasty device 90 along the guidewire 110. The occlusion filler may be loaded.

  A mitral valvuloplasty device 90 is inserted through the patient's vasculature, and the treatment section 120 of the mitral valvuloplasty device 90 is connected to the mitral valve posterior leaflet in the coronary sinus. If it is localized in the vicinity, the guide wire 110 may be removed. However, as an alternative, if the lumen through which the guide wire 110 is inserted need not be used for another purpose, the guide wire 110 may be left without being removed. Such may be advantageous because the guidewire 110 is inserted through the mitral valvuloplasty device 90 while the lumen through which it is inserted (eg, main function lumen pair 10, 205). This is because it fulfills the function of supporting).

  Subsequently, one or more linearity enhancing rods 180 are inserted into one or more main function lumens 170 of the carrier member 145. To do so, the linearity enhancing rod 180 is first inserted into the main function lumen 205 of the catheter shaft 100 and then further inserted into the main function lumen 170 of the carrier member 145. Also, when the mitral valvuloplasty device 90 is inserted into the coronary sinus, the linearity enhancing rod is to be inserted into the main functional lumens 205 and 170 into which the occlusive filler or guide wire has been inserted. Sometimes, the linearity enhancing rod is inserted after the plugging filler or guide wire is removed.

  As the plurality of linearity-enhancing rods 180 are successively inserted into the plurality of main function lumens 170 of the carrier member 145, the rigidity of the carrier member 145 gradually increases, and the shape of the carrier member 145 is accordingly increased. Approaching a straight line shape. That is, the linearity is enhanced. In addition, the remodeling that changes the shape of the expanded mitral valve gradually progresses, and the mitral valve posterior leaflet is pushed forward and moved accordingly, thereby reducing mitral valve regurgitation ( FIG. 14). For each additional linearity enhancing rod 180 inserted into the main functional lumen 170 of the carrier member 145, the degree of mitral regurgitation is observed and the process is repeated until the regurgitation is minimized. If it is determined that it is desirable to remove the linearity enhancing rod 180 once inserted, the rod is removed, and if it is determined that it should be replaced with another linearity enhancing rod, the replacement is performed. And thereby improve the degree of deformation of the biological tissue so that mitral regurgitation is minimized. In essence, the carrier member 145 is positioned in the coronary sinus, and the linearity enhancing rod 180 is inserted into the positioned carrier member 145, so that the implant member 95 is completed at the treatment site. Will be. This scheme provides a number of excellent advantages. Among them, in particular, since a plurality of linearity-enhancing rods are inserted into the carrier member 145 one after another, the therapeutic treatment can be applied “in stages”, so that The degree of deformation can be “precisely adjusted”, thereby enabling optimal treatment. In this regard, it may be preferable to provide the linearity enhancing rod 180 in the form of a kit having a plurality of linearity enhancing rods 180 having different linearity enhancing forces. By doing so, it is possible to easily optimize the magnitude of the deformation force that deforms the living tissue. In this regard, see, for example, FIG. 14A. The various linearity-enhancing rods shown in the figure have three types of lengths, and there are 6 types of rigidity for each length. Therefore, doctors use 18 different types of linearity-enhancing forces. can do. Furthermore, since the force applied to the patient's living tissue for therapeutic purposes can be gradually increased, the risk of damaging the living tissue can be reduced. Furthermore, since the present invention uses a device that has a low risk of damaging living tissue, system components can be manufactured in a simple manner and at low cost. This novel scheme of the present invention also has various other advantages, which can be easily understood by those skilled in the art based on the present disclosure.

  Further, since the carrier member 145 is made of a relatively low friction material such as Teflon (trademark), for example, the sliding when the linearity enhancing rod 180 is inserted into the carrier member 145 is good. The slip when inserting the carrier member 145 into the coronary sinus 30 is also good. Therefore, as the shape of this device gradually approaches the linear shape as a plurality of linearity enhancing rods 180 are successively inserted into the carrier member 145 and the posterior leaflet ring portion is gradually moved forward. The distal and proximal ends of the device must protrude, but the protrusion can be done without difficulty.

  This will be described in more detail. FIG. 14B shows the treatment section 120 of the mitral valvuloplasty device placed in the patient's anatomy. As a plurality of linearity enhancing rods 180 are inserted one after another, the treatment section 120 moves from a state where the linearity is not enhanced (solid line) to a state where the linearity is enhanced (broken line). In this case, the length of the treatment section 120 is constant while the shape of the living tissue changes, so that the distal end portion 150 and the proximal end portion 155 of the treatment section 120 extend along the living tissue. (The amount of movement is indicated by X), but there is little risk of damaging the living tissue. The reason why the biological tissue is less likely to be damaged when the device slides is that the carrier member 145 is made of a relatively low friction material (for example, Teflon (trademark) or the like). As a matter of fact, as a plurality of linearity enhancing rods are inserted one after another, the deformation of the living tissue gradually progresses, so that the sliding of this device also gradually progresses, so that the living tissue may be damaged. Is even smaller.

  The insertion of the mitral valvuloplasty device 90 may be performed by a so-called stylet delivery method. In doing so, the guide wire is utilized to insert the sheath into the coronary sinus, then the guide wire is removed, and the mitral valvuloplasty device 90 is inserted through the sheath to coronate. Stereotaxy into the sinus and subsequently the sheath is removed, leaving the mitral valvuloplasty device 90 in place in the coronary sinus. In that case, the opening of the distal end portion 130 of the mitral valvuloplasty device 90 may be sealed if it is not necessary to be used for other purposes (referred to herein as other uses). Is used for inserting an electrical lead wire, for example, which will be described later).

Further preferred configuration details The size and shape of the linearity enhancing rod 180 is such that, when placed in the coronary sinus, the shape of the coronary sinus more closely approximates that of the coronary sinus. Are sized and shaped to provide increased linearity. More specifically, each of the plurality of linearity enhancing rods 180 has (1) a somewhat greater rigidity than the biological tissue surrounding the mitral posterior leaflet, and (2) a monk in the coronary sinus. It has a shape that is somewhat close to a straight shape compared to the natural curved shape of the portion in the vicinity of the posterior leaflet of the cap valve, and (3) a length that is relatively appropriate for the radius of curvature of the coronary sinus So that the linearity enhancing rod is placed in the patient's coronary sinus, the linearity enhancing rod exerts a linearity enhancing force on the coronary sinus. A forward force is applied to the posterior leaflet of the cap valve so that mitral regurgitation is reduced.

  One important thing is that this carrier member 145 is so small that the linearity enhancing force acting on the wall of the coronary sinus due to the elasticity of the carrier member 145 itself is insignificant. It may be better to configure. This provides a significant advantage because it facilitates if the linearity enhancing rod 180 is not inserted into the carrier member 145 when the carrier member 145 is inserted to the treatment site. Further, the carrier member 145 can be advanced to the treatment site without damaging the living tissue.

  More importantly, the magnitude of the linearity enhancing force that the individual linearity enhancing rod 180 acts on the surface of the coronary sinus is such that the overall linearity enhancing force that should be applied to the wall of the coronary sinus. There are times when it can only be part of it. This can be done because the cumulative effect of the plurality of linearity enhancing rods 180 is used. This also provides significant advantages because it allows the individual linearity enhancing rods to be advanced to the treatment site easily and without damaging living tissue.

  One more important thing is that a plurality of linearity enhancing rods are individually inserted to apply a linearity enhancing force to the mitral annulus. By increasing / decreasing and / or adjusting the rigidity of the linearity-enhancing rod to be used, various linearity-enhancing forces can be applied.

  Also importantly, since the linearity enhancing rod 180 is made of an elastic material, the linearity enhancing rod 180 can gradually advance the remodeling of biological tissue, that is, it takes time. Since it is possible to dynamically affect the joint state of the leaflets, the magnitude of the straightness enhancement force that the individual straightness enhancement rods 180 act on the surface of the coronary sinus can be determined as the joint state of the leaflets. In some cases, the magnitude of the force may correspond to a portion of the overall linearity enhancing force required to achieve a substantially perfect condition. In particular, in this regard, since the living tissue has a dynamic reaction property, the living tissue can be gradually moved to the final position by using a flexible linearity enhancing rod. Therefore, the remodeling of the living tissue can be performed over time, and thereby the risk of damaging the living tissue can be reduced as compared with the case where the remodeling of the living tissue is completed at once.

  Alternatively, the straightening rod 180 may be inserted into one or more main function lumens 170 of the treatment section 120 and the mitral valvuloplasty device 90 may be advanced to the coronary sinus. In addition, the linearity-enhancing rod 180 is inserted into one or more main function lumens 205 of the catheter shaft 100 and the mitral valvuloplasty device 90 is advanced to the coronary sinus. There is also a way to go. However, as described above, the mitral valvuloplasty device 90 is usually inserted into the coronary sinus first, and then the linearity enhancing rod 180 is inserted into the main function lumen 170. It is desirable to do. By doing so, the flexibility of the mitral valvuloplasty device should be made as large as possible when the mitral valvuloplasty device is inserted into the patient's coronary sinus. Can do.

  By inserting a linearity enhancing rod into the auxiliary lumen 175 of the carrier member 145, the desired mitral annulus may be provided. In doing so, the linearity enhancing rod may be inserted into the main function lumen 170 and the linearity enhancing rod may be inserted into the auxiliary lumen 175. Instead of inserting the enhancement rod, a linearity enhancement rod may be inserted into the auxiliary lumen 175.

  In one preferred configuration, a linearity enhancing rod is inserted in both the main function lumen 170 and the auxiliary lumen 175 to provide a desired shape that approximates the shape of the proximal portion of the annulus to a more linear shape. A linearity enhancing effect is obtained.

  Further, in one particularly preferred configuration, the flexibility of the linearity enhancing rod inserted into the main function lumen 170 and the flexibility of the linearity enhancing rod inserted into the auxiliary lumen 175 are described. By setting an appropriate correlation with the size, the linearity enhancing effect of bringing the shape of the vicinity of the annulus closer to the linear shape is further improved.

More specifically, in the linearity enhancing rod 180 according to one preferred embodiment, the flexibility of the end portion S ₄ of the linearity enhancing rod 180 is relatively large as shown in FIG. Thus, the operation of inserting the linearity-enhancing rod through the living body duct to the coronary sinus of the patient is facilitated. However, thereby, since the straightness enhanced force distal portion S ₄ occurs weakens, the region corresponding to the end portion S ₄ of the coronary sinus, closer to the shape of the vicinity of the annulus more linear shape For this reason, there is a risk that the effect of increasing the linearity will be weakened. Therefore, an auxiliary linearity enhancing rod 211 as shown in FIG. 15 is used in combination, and the auxiliary linearity enhancing rod 211 has a base end portion S _{5 having} a first rigidity and a distal end portion thereof. The rigidity of S _{6 is} a second magnitude larger than the first magnitude. The flexibility of the end portion S ₆ of the auxiliary linearity enhancing rod 211 and the end portion S ₄ of the linearity enhancing rod 180 are the same. By setting an appropriate correlation with the degree of flexibility, the linearity enhancing force for bringing the shape of the vicinity of the annulus closer to a straight shape by the combined action of the two end portions Is the desired size.

  In one preferred embodiment of the present invention, the distal end portion of the auxiliary linearity enhancing rod 211 is provided with a flexibility gradient that becomes less flexible toward the proximal side, thereby being more flexible toward the proximal side. The influence of the end portion of the linearity-enhancing rod 180 having a flexible gradient that increases the flexibility is compensated. FIG. 16 illustrates this action. As a method for providing such a flexibility gradient, for example, there are a method of changing the diameter of the rod, a method of using two or more kinds of materials in combination, and other methods.

  In one preferred embodiment of the present invention, one or more auxiliary linearity enhancing rods 211 are first inserted into the auxiliary lumen 210 and then the mitral valvuloplasty device 90 is coronally shaped. One or more linearity-enhancing rods that are intended to be inserted into the sinus and after placement of the mitral valvuloplasty device 90 into the coronary sinus 180 is inserted.

  Further, the linearity enhancing rod 180 is formed of a material capable of withstanding a large stress acting on the linearity enhancing rod 180 (for example, a superelastic metal material such as nitinol), and the auxiliary linearity enhancing rod 211 is attached to the carrier member 45. You may make it form with another material (For example, stainless steel for surgical instruments etc.) which can provide the required high intensity | strength.

  As described above, it is generally desirable that the linearity enhancing rod 180 be inserted into the main function lumen 170 after the mitral valvuloplasty device 90 has been inserted into the coronary sinus, This facilitates the operation of inserting the mitral valvuloplasty device 90 into the coronary sinus.

  In one embodiment of the present invention, a simple method for moving the linearity enhancing rod 180 within the main functional lumen 205 of the catheter shaft 100 and within the main functional lumen 170 of the treatment section 120 is provided. A push rod 215 (FIG. 17) having a simple structure is used. The push rod 215 may be formed separately from the linearity enhancing rod 180 or may be formed integrally with the linearity enhancing rod 180. In one preferred embodiment of the present invention, the push rod 215 is formed integrally with the linearity enhancing rod 180, or the push rod 215 is coupled to the linearity enhancing rod 180.

  Under certain circumstances, an operation to remove the linearity enhancing rod 180 from the main function lumen 170 may be performed. For example, but not limited to this, in order to adjust the linearity enhancing force acting on the mitral valve annulus after the treatment section 120 is positioned in the coronary sinus. It may be necessary or desirable to replace the previously inserted linearity enhancing rod with another linearity enhancing rod. Alternatively, it may be necessary or desirable to remove the mitral valvuloplasty device 90 deployed in the coronary sinus from the coronary sinus, in which case the coronary sinus It may be necessary or desirable to remove the linearity enhancing rod 180 from the treatment section 120 that is positioned therein. When the linearity enhancing rod 180 is removed from the treatment section 120, if the push rod 215 is integrally formed with the linearity enhancing rod 180, or the push rod 215 is attached to the linearity enhancing rod 180. Can be easily removed. That is, in such a case, the linearity enhancing rod 180 can be easily removed simply by picking the proximal end portion of the push rod 215 and pulling it toward the proximal end side.

  When removing the linearity enhancing rod 180 from the treatment section 120, the distal end of the push rod used to insert the linearity enhancing rod 180 can be attached to and detached from the proximal end of the linearity enhancing rod 180. They may be connected and removed using the push rod.

  More specifically, the push rod 220 shown in FIG. 18 is detachably connected to the linearity enhancing rod 180. The push rod 220 has a distal end 225 and a proximal end 230. A distal end portion 225 of the push rod 220 is provided with a flexible coil spring 235, and this coil spring 235 is in contact with the proximal end portion of the linearity enhancing rod 180. A handle 240 is attached to the proximal end 230 of the push rod 220. A central lumen 255 is formed in the push rod 220. A tension wire 260 is inserted through the central lumen 255. One end of the pull wire 206 is connected to the proximal end portion of the linearity enhancing rod 180, and the other end of the pull wire 206 is connected to a pull mechanism 265 attached to the handle 240.

  In use, with the linearity enhancing rod 180 coupled to the push rod 220, the handle 240 is used to insert the linearity enhancing rod 180 into the main functional lumen 170 of the treatment section 120. In addition, the linearity enhancing rod 180 can be removed from the main function lumen 170. When the linearity-enhancing rod 180 is disconnected from the push rod 220 after they are completed, if a sufficiently large tensile force is applied to the pulling wire 260 by operating the pulling mechanism 265, the pulling wire 260 is broken, The pull wire 260 and the linearity enhancing rod 180 can be disconnected, thereby removing the push rod 220 from the mitral valvuloplasty device 90, while the linearity enhancing rod 180 can be removed from the treatment section 120. The main function lumen 170 is left as it is.

  19-21 illustrate various other mechanisms for releasably connecting the linearity enhancing rod to the push rod. The configuration shown in FIGS. 19 to 21 is the same as the configuration of FIG. 18 in the sense that the linearity enhancing rod 180 is detachably connected to the push rod. However, the configurations of FIGS. This has the further advantage that the push rod can be connected again to the linearity-enhancing rod separated from the push rod.

  FIG. 19 shows one specific example of a configuration in which the linearity enhancing rod 180 is releasably connected to the push rod 220 and the once disconnected push rod can be connected to the linearity enhancing rod again. It is an example. This will be described in detail. In the configuration according to this specific example, (1) the proximal end portion of the linearity enhancing rod 180 is provided with a recess 270, and (2) the push rod 220 is an outer cylinder portion with a split groove. 275 and an inner wedge rod 280. When the inner wedge rod 280 is pulled to the proximal end side and pulled out from the outer cylindrical portion 275 with the split groove, the outer cylindrical portion 275 with the split groove is released from the state of being radially expanded, and the inner peripheral surface of the concave portion 270 is released. The holding force is lost, so that the slotted 275 can be taken in and out of the recess 270. On the other hand, after fitting the outer cylindrical portion 275 with the groove into the concave portion 270, the inner wedge rod 280 is moved to the distal side and pushed into the outer cylindrical portion 275 with the groove, so that the outer cylindrical portion with the groove is 275 is in a state of being expanded in the radial direction, and the split grooved 275 can hold the inner peripheral surface of the recess 270, thereby fixing the linearity enhancing rod 180 to the push rod 220. Thereafter, by pulling the inner wedge rod 280 to the proximal end side and pulling it out from the outer cylinder portion 275 having the split groove, the push rod 220 can be pulled out from the linearity enhancing rod 180, thereby increasing the linearity enhancing rod. 180 can be disconnected from the push rod 220.

  FIG. 20 shows another specific example of a configuration in which the linearity enhancing rod 180 can be detachably connected to the push rod 220. This will be described in detail. In the configuration according to this specific example, (1) the proximal end portion of the linearity enhancing rod 180 includes a male portion 285, and (2) the distal end portion of the push rod 220 is A recess 290 having a spring function is provided, and (3) a closing tube 295 is concentrically fitted on the outer periphery of the push rod 220. In this configuration, when the closing tube 295 is pulled to the proximal end side and pulled away from the spring-type recess 290, the distal end of the push rod 220 is released from the state of being pressed from the outside and freely expanded by the spring function. Since the holding force for the male member 285 is lost, the concave portion 290 can be fitted to and detached from the male member 285. On the other hand, if the distal end portion of the push rod 220 is fitted to the outer periphery of the male member 285 and the closing tube 295 is moved to the distal end side and fitted to the outer periphery of the spring-type recess 290, the push rod 220 The distal end holds the male member 285, thereby securing the linearity enhancing rod 280 to the push rod 220. Thereafter, the linearity enhancing rod 130 is separated from the push rod 220 by pulling the closing tube 295 and moving it away from the spring-type recess 290 and withdrawing the push rod 220 from the linearity enhancing rod 180. be able to.

  FIG. 21 shows another specific example of a configuration in which the linearity enhancing rod 180 can be detachably connected to the push rod 220. This will be described in detail. In the configuration according to this example, one of the linearity enhancing rod 180 and the push rod 220 is equipped with one coupling mechanism of a bayonet coupling structure, and the linearity enhancing rod 180 is provided. The other connecting mechanism of the bayonet type connecting structure is provided on the other of the push rod 220 and the push rod 220 so that the linearity enhancing rod 180 can be detachably connected to the push rod 220. It is.

  It will be appreciated by those skilled in the art that various other schemes for releasably connecting the linearity enhancing rod 180 to the push rod 220 may be devised by reference to the present disclosure. .

  As described above, the catheter shaft 100 (FIG. 4) serves to deliver the implant member 95 to the treatment site. When the catheter shaft 100 is delivering the implant member 95 to the treatment site, the distal end 195 of the catheter shaft 100 is coupled to the proximal end of the implant member 95, and some of the present invention In this embodiment, the distal end 105 of the catheter shaft 100 can be disconnected from the proximal end 155 of the implant member 95 at some point after delivery is complete. For this purpose, the implant member 95 may be formed separately from the catheter shaft 100 and may be releasably connected to the catheter shaft 100. Alternatively, the implant member 95 may be connected to the catheter shaft 100. It may be formed integrally with the shaft 100 but detachable from the catheter shaft 100.

  When the implant member 95 is formed separately from the catheter shaft 100 and is releasably connected to the catheter shaft 100, there are various ways to allow selective connection between the two. Configuration can be utilized.

  In one preferable configuration example, as shown in FIG. 22, the implant member 95 and the catheter shaft 100 are detachably coupled to each other using a connecting thread 300. This will be described in detail. The end of one or more connecting threads 300 is inserted and fixed in the auxiliary lumen 175 of the treatment section 120, and the connecting thread 300 is inserted into the auxiliary lumen 210 of the catheter shaft. And pull it out to the proximal side. Subsequently, the implant member 95 and the catheter shaft 100 are integrated by pressing the distal end portion 195 of the catheter shaft 100 against the proximal end portion 155 of the treatment section 120 in a state where the connecting thread 300 is tensioned. It can be handled as if it were one unit. More specifically, when the mitral valvuloplasty device 90 is advanced along the guidewire 110 into the patient's coronary sinus, the implant member 95 is moved distally by pushing with the catheter shaft 100. Can be made. Also, if it becomes necessary to pull out the mitral valvuloplasty device 90, the connecting thread 300 can be pulled proximally, thereby causing the implant member 95 to move proximally (and thus the catheter shaft 1000 to the base). To the end side).

  When the catheter shaft 100 is removed while leaving the implant member 95 at the treatment site, first, the connecting thread 300 is pulled to the proximal end side without moving the catheter shaft 100, thereby connecting thread 300. Then, the connecting thread 300 and the catheter shaft 100 may be removed from the treatment site. FIG. 23 shows one configuration example for realizing such an effect. In this configuration example, the connecting yarn 300 is fixed to the auxiliary lumen 175 by a frictional force, and the frictional force is shown in FIG. Is such that the connecting thread 300 can be pulled out by applying a sufficiently large force (that is, the connecting thread 300 is strong while being pressed by the catheter shaft 300 so that the implant member 95 does not move). Pull it with force).

  Alternatively, only the catheter shaft 100 may be removed while leaving the connecting thread 300, in which case the connection extending from the implant member 95 left at the treatment site to the proximal end side The thread 300 is left as it is. The advantage of this method is that when the implant member 95 needs to be pulled out later, the remaining connecting thread 300 becomes a means for easily accessing the implant member 95 disposed in the body. It is. The ability to remove the implant member 95 from the patient's body is one of the great advantages of the present invention.

  Furthermore, since the connecting thread 300 extends from the implantation member 95 to the proximal end side and is exposed, a cap (not shown) is inserted along the connecting thread 300 and advanced to the implantation member 95. A cap can be attached to the proximal end of the implant member 95. By using such a cap, it is possible to prevent the living tissue from being damaged by the proximal end portion of the implant member 95, and at least some of the interior of the implant member 95 is sealed. Therefore, the risk of causing solidification is reduced.

  The implant member 95 described above is described as one preferred embodiment of the elongated members 175, 184 in the previously referenced US patent application Ser. No. 10 / 446,470. Therefore, the implant member 95 can be placed alone in the body (eg, placed in direct contact with the inner wall of the coronary sinus), and the elongated member 157 in the aforementioned US patent application. , 184, can be placed in the body with any other device, for example, with a stabilizing scaffold or the like.

  In this regard, instead of one relatively large diameter rod (eg, elongate members 157, 184, etc. described in the previously referenced US patent application Ser. No. 10 / 446,470), a plurality of By using small diameter rods (such as the linearity enhancing rods 180, 211 described above), a number of excellent advantages are obtained. This will be described in more detail with reference to FIG. FIG. 24 is a schematic diagram showing the relationship among the rod diameter (A or B), the cross-sectional profile (CP), the peak stiffness (SF), and the peak stress (ST). Here, the “cross-sectional profile” is a profile of the cross-section of the device. More specifically, by using a plurality of rods having a smaller rod diameter B instead of a single rod having a rod diameter A, the cross-sectional profile (CP) of the implant member is reduced, and Peak stiffness (SF) can be increased and peak stress (ST) can be decreased. Therefore, the composite rod type implant member (implant) according to the present invention constituted by a plurality of small-diameter rods is compared with a rod-type implant member (implant) composed of one relatively large-diameter rod. And bring greater benefits.

  Still further, according to an implant device configured in accordance with the present invention, a physician can adjust multiple variables, thereby generating various magnitudes of linearity enhancing force, and thereby Optimal results can be obtained. Adjustable variables include (1) the position of the implant member in the body, (2) the position of the rod to be inserted into the implant member, (3) the length of the rod to be inserted, (4) the rod to be inserted. Rigidity, and (5) the rigidity of the implant member as a whole.

  The mitral valvuloplasty device 90 can be configured as various embodiments, and thus can be used for various applications. For example, in one embodiment of the present invention, the mitral valvuloplasty device 90 is to be used purely as a diagnostic device, and once the diagnostic procedure is completed, The whole thing can be removed. Further, as another embodiment of the present invention, after the treatment is completed, the entire mitral valvuloplasty device 90 can be left in a position where the treatment is performed. is there. In this case, for cost reasons, the mitral valvuloplasty device 90 may be formed by integrally forming the implant member 95 on the catheter shaft 100 (for example, by molding). In yet another form of the invention, once the therapeutic procedure is complete, only the implant member 95 of the mitral valvuloplasty device 90 is left at the treatment site and the other part is removed. The device 90 for mitral valvuloplasty is configured so that In this case, the implant member 95 is formed separately from the catheter shaft 100 and is connected so as to be detachable, and is maintained in a state where both are connected while being placed in the body. Once the procedure is complete, only the implant member 95 of the mitral valvuloplasty device 90 may be left in the coronary sinus and the other portion removed.

  There are many situations in which it is necessary to flush the mitral valvuloplasty device with a cleaning solution. The flushing is performed, for example, to eliminate air emboli, or to supply contrast agent, or the flushing may be performed for other purposes. In those cases, a plurality of lumens are connected to one or more connector portions 305 at their ends, as shown in FIG. 25, to minimize the risk of foreign bodies entering the patient's body. By doing so, a closed channel may be defined. The implant member 95 is formed separately from the catheter shaft 100, and the cleaning liquid needs to flow from the main function lumen 205 of the catheter shaft 100 to the main function lumen 170 of the implant member 95. In some cases, the connection between the implant member 95 and the catheter shaft 100 needs to be a liquid-tight connection.

  The treatment section 120 may be formed to have the same circular cross-sectional shape over its entire length (for example, the cross-sectional shape as shown in FIG. 6), or the cross-sectional shape changes depending on the longitudinal position thereof. You may form so that it may do. Specific examples thereof include, but are not limited to, for example, the treatment section 120 has a circular cross-sectional shape (FIG. 26) at its end 150, and its longitudinal intermediate portion. That is, the mitral valve has a rectangular or trapezoidal cross-sectional shape (FIG. 27) at the P2 leaflet in the vicinity of the mitral valve, and a relatively flat cross-sectional shape at the base end 155 (FIG. 28). You may make it form so that it may have. Further, when the cross-sectional shape of the treatment section 120 is a shape other than a circular shape, the treatment section 120 is constrained during the operation of inserting into the surgical site, so that the treatment section 120 has a circular cross-section. It may be desirable to have a shape that facilitates insertion of the treatment section through the patient's vasculature. To achieve this, the treatment section 120 may be housed in a removable sheath 310 (FIG. 28) and removed after the treatment section 120 has been localized to the surgical site. Thereby, the shape of the treatment section 120 restores the required shape.

  FIG. 26 to FIG. 28 further illustrate that a plurality of lumens extending through the treatment section 120 may all have the same diameter.

  As already mentioned, the implant member 95 may be arranged with a stabilizing scaffold, and the stabilizing scaffold used may be of the type disclosed, for example, in the previously referenced US patent application Ser. No. 10 / 446,470. Can be. Such stabilizing scaffolds help to distribute the force that the mitral valvuloplasty device exerts on the wall of the coronary sinus, and the central portion of the treatment section 120 moves longitudinally offset. It also helps to stabilize the device (however, the distal and proximal ends of the device are the surfaces of living tissue when the linearity-enhancing rod is inserted and the shape of the device tries to be linear). It is generally preferable to be able to move while in contact with the Furthermore, a structure 315 (FIG. 29) that promotes ingrowth of living tissue may be provided on a part of the outer peripheral surface of the treatment section 120, so that the central portion of the treatment section 120 is provided. Can be more firmly fixed in the coronary sinus. Specific examples thereof include, but are not limited to, forming irregular or “fuzzy” irregularities on the outer peripheral surface of the treatment section 120 and / or the outer peripheral surface thereof. You may make it coat the ingrowth growth promoter which promotes the ingrowth of a biological tissue. In one preferred embodiment of the present invention, the surface structure 315 is a graft member, and is preferably formed of a hybrid material using Dacron (trademark) and Teflon (trademark). This is fixed to the body of the manufactured treatment section 120, and the graft member has a large static friction force and a large endothelial growth promoting property.

Corridor System The mitral valvuloplasty device 90 according to one preferred embodiment shown in FIGS. 30 and 31 is a re-accessible “extension” that extends to the implant member 95 after completion of the implantation procedure. The “corridor (passage)” is configured to remain. To achieve this, (1) the mitral valvuloplasty device 90 is a “single unit” structure in which the proximal end 155 of the treatment section 120 and the distal end of the catheter shaft 100 are integrally formed. And (2) the mitral valvuloplasty device 90 is configured to access the patient's vasculature from the subclavian vein, and (3) after completion of the implantation procedure, A cap 320 is applied to the proximal end of the catheter shaft so that it is secured in a “pocket” formed subcutaneously in the patient, which will be described in more detail below.

  More particularly, in this embodiment of the present invention, the mitral valvuloplasty device 90 is preferably inserted along the guide wire as described above, and the insertion is complete. If so, the lead section 115 goes down into the AIV and faces down, the treatment section 120 is placed in the coronary sinus in the region near the mitral posterior leaflet, and the catheter shaft 100 from there Passes through the right atrium, extends upwards through the superior vena cava, extends upwards through one of the subclavian veins, and penetrates the vessel wall of the subclavian vein And extend outside the body. In one preferred embodiment of the present invention, the diameter of the mitral valvuloplasty device 90 is about 7 French.

  The mitral valvuloplasty device 90 preferably passes through a stable support scaffold 325, which is positioned in the coronary sinus and near the coronary ostium 45. Device 90 is slidably supported. As such a support scaffold 325, the one disclosed in the aforementioned US patent application Ser. No. 10 / 446,470 may be used. In addition, the support scaffold 325 is not limited thereto, and serves to distribute the force exerted on the wall of the coronary sinus 90 by the mitral valvuloplasty device 90. Any suitable configuration can be used as long as it can slide relative to the support scaffold. The mitral valvuloplasty device 90 preferably further comprises a region 315 that allows ingrowth of biological tissue, which secures the central portion of the treatment section 120 to the coronary sinus. To help. Also, this region 315 preferably comprises a graft 330 that functions as a corrosion resistant sleeve that fits around the distal end of the treatment section 120 of the mitral valvuloplasty device 90.

  It should be noted that in the configuration described above, after the mitral valvuloplasty device 90 is properly positioned in the coronary sinus, the linearity enhancing rod 180 is inserted into the main functional lumens 205, 170, thereby The patient's anatomy is deformed to reduce mitral regurgitation.

  Once the linearity enhancing rod 180 has been inserted into the main function lumen 170, thereby deforming the patient's anatomy to reduce mitral regurgitation, the tubular bumper coil 335 is then continued. A suitable instrument such as (FIG. 31) is inserted into the main function lumen 205 to fill the gap in the main function lumen 205, thereby ensuring that the linearity enhancing rod 180 does not move within the main function lumen 170. To fix. When the linearity enhancing rod 180 includes the above-described tension wire 260 (FIG. 18), the tension wire may be passed through the tubular bumper coil 335.

  However, when the linearity enhancing rod 180 is connected to a push rod 215 (for example, a push rod as shown in FIG. 17), an instrument such as a bumper coil is usually unnecessary, because This is because the push rod 215 assumes the function of the bumper coil, fills the gap of the main function lumen 205, and securely fixes the linearity enhancing rod 180 so as not to move in the main function lumen 170.

  When the above is complete, the proximal end of the catheter shaft 100 is received in a “pocket” formed subcutaneously in the patient's torso. More particularly, the proximal end of the catheter shaft 100 is trimmed to an appropriate length (if it is too long) and received in a subcutaneous pocket with a cap 320 applied. The cap 320 may be a “single” cap having a simple structure, but it is more preferable that the cap 320 includes an inner cap 340 and an outer cap 355. The inner cap 340 in that case is preferably provided with a seal 345 and a plug 350, and the plug 350 is attached to the inner cap 340, a pull wire 260, a bumper coil 335 or a push rod 215 (straight line). The push rod 215 is connected to the degree-strengthening rod 180). On the other hand, the outer cap 355 is simply fitted and attached to cover the entire tail portion of the mitral valvuloplasty device. It is preferable that the outer cap 355 has a shape that is less likely to damage the tissue and does not give the patient a sense of incongruity.

  The “corridor system” according to this embodiment provides a number of excellent advantages. Among these benefits, it provides an easy access path to the implanted device, making it easier to adjust the degree of tissue deformation after the implantation procedure is complete. There are things you can do. To do this, for example, open the subcutaneous pocket to access the proximal end of the mitral valvuloplasty device, remove the outer cap 355, remove the inner cap 340, and remove the tubular bumper coil 335. Pull out, pull out the linearity enhancing rod 180 using the pull wire 260, insert the linearity enhancing rod 180 used instead, refit the tubular bumper coil 335, and this mitral valve The cap may be reattached to the plastic device (or if the linearity enhancing rod 180 is connected to the push rod 215, the subcutaneous pocket is opened and the proximal end of the mitral valve device Access, remove the outer cap 355, remove the inner cap 340, and use the push rod 215 to remove the linearity enhancing rod 180 The degree of linearity enhancement rod 180 to be used instead inserted through the push rod 215, and may be re-attached cap to the device for mitral valvuloplasty). Alternatively, it provides an easy access path to the implanted device so that it can be removed when the entire implanted device is to be removed from the patient's body. Open to access the proximal end of the mitral valvuloplasty device, remove the outer cap 355, remove the inner cap 340, remove the tubular bumper coil 335, and use the pull wire 260 to straighten The rest of the mitral valvuloplasty device may be removed (or increased linearity) by removing the degree enhancement rod 180 and pulling the proximal end of the catheter shaft 100 proximally. When the rod 180 is connected to the push rod 215, the subcutaneous pocket is opened to access the proximal end of the mitral valve device. Removing the outer cap 355, removing the inner cap 340, using the push rod 215 to remove the linearity enhancing rod 180 and pulling the proximal end of the catheter shaft 100 proximally To remove the remaining portion of the mitral valvuloplasty device.

  Furthermore, the mitral valvuloplasty device 90 is a “single unit” structured device that, when used, can be sized (ie trimmed) at the proximal end so that it fits within the subcutaneous pocket. As such, device dimensional issues (and hence inventory issues) are greatly reduced.

  Shown in FIGS. 32-38 is a mitral valvuloplasty device 90 according to another preferred embodiment. In this configuration, the implant member 95 is formed integrally with the catheter shaft 100 (see FIGS. 32 to 34 and FIG. 36), and the linearity enhancing rod 180 is connected to the push rod 215 ( (See FIG. 38). Further, three main function lumens 205 are formed on the catheter shaft 100 (FIG. 35), and three main function lumens 170 are formed on the implant member 95 (not shown in FIGS. 32 to 38). (Illustrated). The surface structure 315 provided for fixing the central portion of the treatment section 120 and for promoting the in-growth of living tissue is a suture wound spirally around the outer periphery of the treatment section. (FIGS. 32-34 and 36). A large diameter portion 400 (FIG. 38) may be formed on the shaft of the push rod 215 to improve the visibility when the fluoroscope is used. A cap 500 closes the proximal end of the catheter shaft 100.

  The devices in FIGS. 32 to 38 preferably adopt the “corridor” method. More particularly, the mitral valvuloplasty device 90 is preferably introduced from the subclavian vein into the patient's vasculature and inserted into the coronary sinus. Subsequently, one or more linearity enhancing rods 180 are inserted into the main function lumens 205, 170 to deform the patient's anatomy to reduce mitral regurgitation. Subsequently, a cap 500 is applied to close the proximal end of the mitral valve device. Subsequently, the proximal end of the mitral valvuloplasty device 90 is received in the subcutaneous pocket. Thereafter, if adjustments need to be made to the mitral valvuloplasty device 90 (eg, by adding, removing, or replacing one or more linearity enhancing rods 180), the subcutaneous pocket And removing the cap 500 to re-access the mitral valvuloplasty device system.

USES FOR USING A MITTERAL VALVE DEVICE WITH AN ELECTRICAL LEAD The novel mitral valve device according to the present invention can be used with an electric lead, such as an implant. Electrical leads for shaped biventricular pacing devices, implantable defibrillators, etc. The manner of using this mitral valvuloplasty device with an electrical lead can provide significant advantages because the electrical lead is typically generally a mitral valvuloplasty device. This is because it is inserted into the same body route as the body route into which 90 is inserted, that is, the body route is a body route from the normal vascular access site (for example, the left subclavian vein 25) to the AIV 60.

  Of course, but not limited to this, in one preferred embodiment of the invention, one or more electrical leads are first passed through the coronary sinus. In addition, the AIV is further passed through and inserted into an appropriate living tissue ahead. The guide wire 110 is then inserted into the coronary sinus. However, conversely, the guide wire 110 may be inserted first into the coronary sinus and then one or more electrical leads may be inserted. Subsequently, the mitral valvuloplasty device 90 is attached to the guidewire and electrical lead. In doing so, the proximal end of the guide wire is inserted into the main function lumen pair 170, 205 aligned with each other, and the main function lumen pair 170, 205 aligned with each other (or positioned relative to each other). Insert electrical leads (to other lumens such as matched auxiliary lumen pairs 175, 210). Subsequently, the mitral valvuloplasty device 90 is advanced distally along the guidewire and electrical lead. Once the mitral valvuloplasty device 90 is positioned in place in the coronary sinus, the linearity enhancing rod 180 is inserted as previously described.

  As a specific example showing such a case, FIG. 39 shows an electrical lead 600 extending from the distal end portion of the mitral valvuloplasty device.

  Alternatively, in another embodiment of the invention, an electrical lead is used in place of the guidewire to guide the mitral valvuloplasty device to a target location in the coronary sinus, and the guide Wire is not used. More particularly, in this embodiment of the invention, one or more electrical leads are first passed through the coronary sinus and further through the AIV to the appropriate living tissue beyond. I try to insert it. Subsequently, the mitral valvuloplasty device 90 is attached to the electrical lead. In doing so, electrical leads are inserted into the primary function lumen pairs 170, 205 aligned with each other (or into other lumens such as the auxiliary lumen pairs 175, 210 aligned with each other). Subsequently, the mitral valvuloplasty device 90 is advanced distally along its electrical lead. Once the mitral valvuloplasty device 90 is positioned in place in the coronary sinus, the linearity enhancing rod 180 is inserted as previously described.

  Of course, the lumens that are to be threaded through one or more electrical leads are required for use in other applications (e.g., each other required to insert a linearity enhancing rod). In the case of the aligned main function lumen pair 170, 205), more luminal devices may be pre-formed on the mitral valve device. In addition, if both the electrical lead and the linearity-enhancing rod must be housed in the same lumen, a lumen is formed on the linearity-enhancing rod itself and the electrical lead is connected to its linearity. By inserting the lumen of the reinforcing rod, the linearity enhancing rod and the electric lead wire may be arranged concentrically.

  In yet another preferred embodiment of the present invention, one or more electrical leads are inserted through the mitral valvuloplasty device previously positioned in the body. More particularly, in this embodiment of the present invention, after the mitral valvuloplasty device has been localized into the coronary sinus, one or more electrical leads are connected to the mitral valvuloplasty device. It is inserted through the lumen and extended from the distal end of the mitral valvuloplasty device to reach the appropriate biological tissue. In this embodiment of the present invention, the mitral valvuloplasty device 90 may be inserted along the guide wire for delivery to the coronary sinus, as described above. In this way, it may be inserted by a stylet delivery method.

  In yet another embodiment of the invention, one or more electrical leads are pre-installed, such as by “built in” to the mitral valvuloplasty device. In such a configuration, the mitral valvuloplasty device and the electrical lead are simultaneously inserted into the patient's body.

  Of course, those skilled in the art will envision other uses of the novel mitral valvuloplasty device in conjunction with the electrical lead based on the present disclosure.

In order to clarify the essence of the present invention, specific configurations, materials, procedures, and combinations of parts have been described and exemplified above. It is obvious that those skilled in the art can make a wide variety of modifications included in the scope, and the scope of the present invention is as specified by the description of the scope of claims.

It is the schematic diagram which showed partially the human vascular system. It is the schematic diagram which partially showed the human heart. It is the schematic diagram which showed the novel device for mitral valvuloplasty in the state inserted in the patient's body. It is the schematic diagram which showed one suitable structural example of the device for mitral valvuloplasty. FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. It is the schematic diagram which showed one form of the 1 linearity enhancement rod. It is the schematic diagram which showed another one form of the linearity enhancement rod. It is the schematic diagram which showed another one form of the linearity enhancement rod. It is the schematic diagram which showed the linearity enhancement rod of another form. It is the schematic diagram which showed the linearity enhancement rod of another form. It is sectional drawing along the 11-11 line of FIG. FIG. 6 illustrates a use for reducing mitral regurgitation using a mitral valvuloplasty device. FIG. 6 illustrates a use for reducing mitral regurgitation using a mitral valvuloplasty device. FIG. 6 illustrates a use for reducing mitral regurgitation using a mitral valvuloplasty device. It is the schematic diagram which illustrated that the linearity reinforcement | strengthening force of the various magnitude | size over a wide range can be provided with the kit which stocked multiple types of linearity reinforcement rods. Explains that the mitral valvuloplasty device slides relative to the living tissue with no risk of damaging the living tissue as the coronary sinus shape approaches the rectilinear shape to reduce mitral regurgitation It is a schematic diagram for doing. It is the schematic diagram which showed the auxiliary | assistant linearity enhancement rod. It is a schematic diagram for giving an inverse correlation between the flexibility gradient of the linearity enhancing rod and the flexibility gradient of the auxiliary linearity enhancing rod. It is the schematic diagram which showed one form of the push rod for inserting a linearity enhancing rod into an implantation member. It is the schematic diagram which showed another one form of the push rod for inserting a linearity enhancing rod into an implantation member. It is the schematic diagram which showed another one form of the push rod for inserting a linearity enhancing rod into an implantation member. It is the schematic diagram which showed another one form of the push rod for inserting a linearity enhancing rod into an implantation member. It is the schematic diagram which showed another one form of the push rod for inserting a linearity enhancing rod into an implantation member. It is the schematic diagram which showed one suitable example of the method of detachably connecting an implantation member to a catheter shaft. It is the schematic diagram which showed an example of the method of isolate | separating a connection thread | yarn from an implantation member. It is the schematic diagram which showed the relationship between a rod diameter, a cross section, peak rigidity, and peak stress. It is a schematic diagram illustrating how a plurality of lumens may be formed to define a closed flow path. It is the schematic diagram which illustrated how the treatment section of the device for mitral valvuloplasty where a cross-sectional shape changes with longitudinal positions should be formed. It is the schematic diagram which illustrated how the treatment section of the device for mitral valvuloplasty where a cross-sectional shape changes with longitudinal positions should be formed. It is the schematic diagram which illustrated how the treatment section of the device for mitral valvuloplasty where a cross-sectional shape changes with longitudinal positions should be formed. FIG. 6 is a schematic diagram illustrating how the outer surface of a mitral valve device may be formed to enhance device stability by promoting ingrowth of biological tissue. FIG. 6 is a schematic diagram illustrating another embodiment of the present invention in which the mitral valvuloplasty device has a “single unit” structure and the implantation procedure is complete. In this embodiment, the proximal end portion of the mitral valvuloplasty device is housed in a “pocket” formed subcutaneously in the chest of the patient. FIG. 31 is a schematic view illustrating a cap that is attached to the proximal end of the mitral valvuloplasty device of FIG. 30 before the proximal end is received in the subcutaneous pocket. It is the figure which showed another suitable example of the device for mitral valvuloplasty. FIG. 33 is another view showing the mitral valvuloplasty device of FIG. 32; FIG. 33 is another view showing the mitral valvuloplasty device of FIG. 32; FIG. 33 is another view showing the mitral valvuloplasty device of FIG. 32; FIG. 33 is another view showing the mitral valvuloplasty device of FIG. 32; FIG. 33 is another view showing the mitral valvuloplasty device of FIG. 32; FIG. 33 is another view showing the mitral valvuloplasty device of FIG. 32; FIG. 5 shows electrical leads extending from the distal end of the mitral valve device.

Claims (40)

In an assembly that reduces mitral regurgitation,
An elongate carrier member having a first shape generally along the shape of the coronary sinus when inserted into the coronary sinus and more linear than the first shape The elongated carrier member is made of a material having a sufficiently large flexibility so as to exhibit a second shape that is a shape that is closer to a linear shape when biased so as to have a shape close to Has a plurality of lumens extending through its longitudinal direction,
A plurality of linearity enhancing rods insertable into the lumen, each of the plurality of linearity enhancing rods,
(1) It has greater rigidity than that of the living tissue around the mitral posterior leaflet,
(2) the coronary sinus has a shape that is closer to a straight line than the shape of the portion near the posterior leaflet of the mitral valve; and
(3) having an appropriate length relative to the radius of curvature of the coronary sinus;
If the linearity enhancing rod is inserted into the lumen with the carrier member positioned near the mitral posterior leaflet in the patient's coronary sinus, the insertion The straightness enhancing rod acts on the wall of the coronary sinus to move the annulus of the mitral posterior leaflet forward, thereby improving the joint state of the leaflet. Mitral regurgitation is reduced,
At least one lumen of the plurality of lumens is dimensioned to allow insertion of an electrical lead.
An assembly characterized by that.   The assembly of claim 1, wherein the carrier member has a circular cross-sectional shape in at least a portion thereof.   The assembly of claim 1, wherein the carrier member has an oval cross-sectional shape in at least a portion thereof.   The assembly according to claim 1, wherein the linearity-enhancing rod has a different degree of rigidity depending on its longitudinal position.   2. The assembly according to claim 1, wherein the linearity-enhancing rod is selected from a kit comprising a plurality of rods having different rigidity.   2. The assembly according to claim 1, wherein the linearity enhancing rod is selected from a kit having a plurality of rods having different lengths.   The assembly according to claim 1, further comprising a guide wire, wherein the carrier member further has an opening through which the guide wire is movably inserted.   The assembly of claim 7, wherein the opening is one of the plurality of lumens.   9. The assembly of claim 8, wherein the plurality of lumens have different diameters.   9. The assembly of claim 8, wherein the stiffness of the first linearity enhancing rod is different from the stiffness of the second linearity enhancing rod.   2. The stiffness magnitude in at least a portion of the first linearity enhancing rod and the stiffness magnitude in at least a portion of the second linearity enhancing rod are inversely correlated. The assembly described.   The assembly of claim 1, further comprising a sheath for constraining the carrier member, the sheath being removable from the carrier member.   The sheath restrains the carrier member so that the carrier member exhibits a first cross-sectional shape. When the sheath is removed, the carrier member is released and the carrier member is 13. An assembly according to claim 12, wherein the assembly has a cross-sectional shape of two.   The assembly according to claim 1, wherein the linearity-enhancing rod has a substantially linear shape in an unstressed state.   The assembly of claim 1, wherein the linearity enhancing rod is substantially curved when inserted into a coronary sinus.   The linearity enhancing rod has a first end and a second end integrally connected by an intermediate portion, and the intermediate portion is a first region and a second region integrally connected by a central region. The central region, the first end, and the second end are substantially curved when the elongate member is inserted into the coronary sinus, and further, the first region The assembly of claim 1, wherein the second region has a generally straight shape after the elongate member is inserted into the coronary sinus.   The assembly of claim 16, wherein the first region and the second region are stiffer than the central region, and the central region is stiffer than the first end and the second end. .   The elongate member exerts a forward force on the wall surface of the coronary sinus in the vicinity of the mitral posterior leaflet, and in the coronary sinus in the vicinity of the mitral commissure. The lengths of the central region, the first end, the second end, the first region, and the second region are determined so that a backward force is applied to the wall surface of the portion. The assembly of claim 16.   The assembly according to claim 1, wherein at least a part of the linearity enhancing rod is formed of an elastic material.   The assembly of claim 1, wherein the linearity enhancing rod continues to act to remodel the mitral valve continuously over an extended period of time.   The assembly of claim 1, wherein at least a portion of the linearity enhancing rod is formed of a superelastic material.   The assembly of claim 1, further comprising a stabilizing scaffold, the stabilizing scaffold engaging the elongated carrier member.   The assembly of claim 1, wherein at least a portion of the elongate carrier member is structured to promote ingrowth of biological tissue.   The assembly of claim 1, further comprising an electrical lead extending through the lumen.   25. The assembly of claim 24, wherein the electrical lead is inserted through the lumen before the elongate carrier member is localized in a patient.   25. The assembly of claim 24, wherein the electrical lead is inserted through the lumen after the elongate carrier member has been localized within a patient. In a method for reducing mitral regurgitation,
Preparing a flexible carrier member in which a plurality of lumens extending through the longitudinal direction are formed;
An electrical lead is inserted through the patient's vasculature to place the distal end of the electrical lead into the patient's coronary sinus and a guidewire is inserted through the patient's vasculature to guide the guide Place the distal end of the wire into the patient's coronary sinus,
Inserting the carrier member along the outer circumference of the electrical lead and the guide wire to place the distal end of the carrier member into the coronary sinus of the patient;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
A method characterized by that.   28. The method of claim 27, wherein the guidewire is inserted into the patient's coronary sinus after the electrical lead is inserted into the patient's coronary sinus.   28. The method of claim 27, wherein the electrical lead is inserted into the patient's coronary sinus after the guidewire is inserted into the patient's coronary sinus.   28. The method of claim 27, wherein the electrical lead and the guidewire are inserted through the lumen. In a method for reducing mitral regurgitation,
Preparing a flexible carrier member in which a plurality of lumens extending through the longitudinal direction are formed;
Inserting an electrical lead through the patient's vasculature and placing the distal end of the electrical lead into the patient's coronary sinus;
Inserting the carrier member along the outer periphery of the electrical lead and placing the distal end of the carrier member into the coronary sinus of the patient;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
A method characterized by that.   The method of claim 32, wherein the electrical lead is threaded through the lumen. In a method for reducing mitral regurgitation,
Preparing a flexible carrier member in which a plurality of lumens extending through the longitudinal direction are formed;
Inserting the carrier member through the patient's vasculature and placing the distal end of the carrier member into the patient's coronary sinus;
Inserting an electrical lead through the carrier member to place the distal end of the electrical lead into the patient's coronary sinus;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
A method characterized by that.   34. The method of claim 33, wherein the flexible carrier member is inserted into the patient's coronary sinus along the circumference of the guidewire.   34. The method of claim 33, wherein the flexible carrier member is inserted into a patient's coronary sinus in a stylet delivery manner.   34. The method of claim 33, wherein the electrical lead is passed through the lumen. In a method for reducing mitral regurgitation,
A plurality of lumens extending through in the longitudinal direction are formed, and a flexible carrier member having an electrical lead inserted through the lumen is prepared.
Inserting the carrier member through the patient's vasculature to place the distal end of the carrier member into the coronary sinus of the patient and localizing the electrical lead to the biological tissue of the heart;
A plurality of linearity enhancing rods are inserted into the plurality of lumens, and a linearity enhancing force is applied to the coronary sinus by applying a linearity enhancing force to the carrier member, whereby the mitral valve Move the annulus forward to reduce mitral regurgitation,
A method characterized by that.   38. The method of claim 37, wherein the flexible carrier member is inserted into the patient's coronary sinus along the circumference of the guidewire.   38. The method of claim 37, wherein the flexible carrier member is inserted into a patient's coronary sinus in a stylet delivery manner.   40. The method of claim 38, wherein the guidewire is inserted through the lumen.

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