JP2006507104A - Method and apparatus for remodeling extravascular tissue structure - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device and method for remodeling a mitral valve annulus adjacent to a coronary vein sinus (22).SOLUTION: The medical device and method for remodeling the mitral valve annulus adjacent to the coronary vein sinus (22) is provided with an elongate body (40) having a proximal end (42) and a distal end (44). The elongate body (40) is movable from a first flexible configuration for transluminal delivery to at least a portion of the coronary vein sinus (22) to a second configuration for remodeling the mitral valve annulus. This medical device is a forming element mounted to the elongate body and is also provided with a forming element for operating the elongate body from a first supplying configuration to a second remodeling configuration.

Description

(Background of the Invention)
(Technical field)
The present invention relates to an endovascular prosthesis for remodeling extravascular anatomy.

(Description of prior art)
Dilated cardiomyopathy results from many different disease processes that impair myocardial function, such as coronary artery disease and hypertension. The left ventricle enlarges and the ejection fraction decreases. The resulting increase in pulmonary venous pressure and decrease in cardiac output cause congestive heart failure. Mitral annulus and enlargement of the left ventricular cavity results in mitral valve dysfunction. The result is an overload that exacerbates muscle damage, causes progressive hypertrophy and exacerbates mitral regurgitation.

  According to recent estimates, more than 79,000 patients each year are diagnosed with aortic and mitral valve disease in US hospitals. Within the United States, more than 49,000 mitral or aortic valve replacement procedures are performed annually, along with a vast number of heart valve repair procedures.

  Various surgical techniques have been developed to repair diseased or damaged valves. One repair technique that has been found to be effective for treatment-incompatible cases, particularly for mitral and tricuspid valves, is annuloplasty, where a prosthetic annuloplasty ring is attached to the endocardial surface of the heart around the annulus To contract the effective size annulus. Annuloplasty rings are made of a metal, such as stainless steel or titanium, or a flexible material such as a silicone rubber or dacron rope coated with a biocompatible fabric or cloth that allows the ring to be sutured to heart tissue. Including. Annuloplasty rings are rigid or flexible and are divided or continuous and have a variety of shapes such as circular, D-shaped, C-shaped or kidney-shaped. Examples are U.S. Pat. Nos. 4,917,698, 5,061,277, 5,290,300, 5,350,420, 5,104,407, 5,064, 431, 5,201,880 and 5,041,130, which are incorporated herein by reference.

  The annuloplasty ring may be used in combination with other repair techniques, such as ablation, in which case a portion of the valve leaflet is removed and the rest of the leaflet is sutured back together and then the prosthetic annuloplasty Attach a ring to the annulus to maintain the contraction size of the valve. Other valve repair techniques currently in use include incisions (cutting the valve commissures to isolate the melted valve leaflets, shortening the mitral or tricuspid tendon, or the isolated monks. A method of re-attaching the cap leaflet or tricuspid tendon or papillary muscle tissue to decalcify the valve leaflets or rings is a repair procedure where annulus ring contraction or stabilization may be desirable. Used in combination with.

  Mitral valve repair and replacement can successfully treat many patients with mitral valve dysfunction, but currently used techniques involve significant morbidity and mortality. Most valve repair and replacement procedures generally require a thoracotomy in the form of a median sternotomy in order to gain access to the patient's thoracic cavity. A saw or other cutting instrument is used to longitudinally cut the sternum to allow the two anterior or abdominal halves of the rib cage to separate. Thus, a large opening is formed in the thoracic cavity through which the surgical team can operate with the visualization of the heart and other thoracic contents directly. According to an alternative, a thoracotomy is performed on the side of the chest and a large incision is made approximately parallel to the ribs, and the ribs are separated and / or removed within the incision area to facilitate surgery. Make enough openings.

  Surgical intervention within the heart generally requires isolating the heart and coronary blood vessels from other parts of the arterial system to stop heart function. Generally, the heart introduces a lateral aortic cross clamp by sternotomy and applies the cross clamp to the aorta to occlude the aortic lumen between the brachiocephalic artery and the coronary artery entrance. Next, myocardial palsy fluid is ejected into the coronary artery directly to the coronary artery entrance or through a puncture in the ascending aorta to stop cardiac function.

  Particular benefits of this application include techniques for repairing and replacing the mitral valve. The mitral valve, located between the left atrium and the left ventricle of the heart, is most easily reached through the left atrial wall that lies on the posterior side of the heart, opposite the side of the heart exposed by a median sternotomy . Thus, to access the mitral valve by sternotomy, the heart is rotated so that the left atrium is in an anterior position. Next, an open or atrial incision is made on the right side of the left atrium in front of the right pulmonary vein. The atrial incision is contracted with a suture or contraction device to expose the mitral valve adjacent to the atrial incision. The valve is then repaired or replaced using one of the techniques that have been previously identified.

  Alternative techniques to mitral valve access have been used where median sternotomy and / or heart rotation manipulations are appropriate. In this technique, the thoracotomy is usually formed in the fourth or fifth intercostal region on the right side of the chest. One or more ribs are removed from the patient, and the other ribs near the incision are contracted outward to form a large opening in the thoracic cavity. The left atrium is then exposed behind the heart and an atrial incision is made in the left atrial wall from which the mitral valve is accessed for repair or replacement.

  Using this open chest technique, a large opening formed by a median sternotomy or thoracotomy allows the surgeon to observe the mitral valve directly from the atrial incision and approach the outside of the heart to enter the thoracic cavity. Place your hand on the aorta and / or coronary artery to induce cardiac paralysis, manipulate the surgical instrument, remove the removed tissue, introduce an annuloplasty ring, or valve from the atrial incision Can be replaced and mounted in the heart.

  Mitral valve surgery, including mitral valve annuloplasty, is generally applied to patients with inherent diseases of the mitral valve organ. As noted above, these patients may have valve leaflet scarring, regression, rupture or adhesion, and disease of the valve organ. Final repair requires direct visualization of the valve.

  Patients who develop mitral regurgitation as a result of dilated cardiomyopathy necessarily have intrinsic mitral valve disease. Backflow occurs as a result of the leaflets that run against each other by the expansion ring. The ventricles expand and become spherical, pulling papillary muscles and tendons away from the plane of the valve, further expanding the reflux orifice. For these patients, regurgitation does not require repair of the valve leaflets themselves, but simply reduces the size of the annulus and can be a true sphere of the left ventricle.

  Mitral annuloplasty without lobular or tendon repair has been found to be effective in patients with dilated cardiomyopathy and refractory to conventional medical therapy. Dr. Steve Bolling and colleagues at the University of Michigan operated on a cohort of patients with symptoms of New York Heart Association cardiac function classification III and IV. The average symptom severity decreased from 3.9 before surgery to 2.0 after surgery. Hemodynamics and ejection fraction were significantly improved. Other investigators achieved similar results. However, the mortality, risk and cost of surgical annuloplasty is very high for patients with cardiomyopathy and congestive heart failure. Accordingly, a variety of new technologies for the treatment of congestive heart failure are being sought as an adjunct to drug therapy.

  Several cardiac suppression devices have been described. US Pat. No. 5,702,343, issued to Alferness, discloses a cardiac enhancement device that is applied as a jacket over the epicardium to limit dilation of the heart. However, this requires open chest surgery for implantation and does not directly affect the mitral annulus diameter. Another method is disclosed in US Pat. No. 5,961,440 issued to Schweich, in which the tension member passes through the opposing walls of the heart so as to cross the ventricle. Be placed. Rather than being relatively invasive to repair and replace the valve, “minimal” invasive techniques continue to evolve for both stationary and beating hearts. While these techniques offer several benefits over the chest opening procedure, they are still associated with significant mortality and risk of death.

  Thus, a need continues to exist for methods and devices for treating mitral valve dysfunction, which methods and devices are achieved by significantly reducing morbidity and mortality over current techniques, and thus It would be well suited for patients with dilated cardiomyopathy. Optimally, this procedure can be accomplished by a percutaneous, transluminal approach using a simple implantable device without relying on prosthetic valve leaflets or other moving parts.

(Summary of Invention)
In accordance with one aspect of the present invention, a medical device for remodeling a mitral annulus adjacent to a coronary sinus is provided. The device includes an elongated body including a proximal end and a distal end. The elongate body is movable from a first flexible configuration for transluminally supplying at least a portion of the coronary sinus to a second configuration for remodeling the mitral annulus. The medical device also includes a forming element attached to the elongate body for manipulating the elongate body from a first delivery configuration to a second remodeling configuration. The elongated body in the second remodeling configuration includes at least a first curve that is concave in the first direction and a second curve that is convex in the second direction.

  In one embodiment, the body includes a third curve that is concave in the second direction when in the second configuration. The elongate body may comprise a tube having a plurality of transverse slots therein. In one embodiment, the medical device further comprises a lock for holding the body in the second configuration. The device is movable from a delivery configuration to a remodeling configuration in response to a proximal retraction of at least a portion of the forming element. In one embodiment, the device is movable from an implanted configuration to a remodeling configuration in response to distal advancement of at least a portion of the forming element. In one embodiment, at least a first portion of the forming element extends within the body and a second portion of the forming element extends along the outside of the body.

  In one embodiment, the medical device further comprises at least one fixation device for engaging a site within the blood vessel. The fixation device comprises at least one wing for piercing the vessel wall. In one embodiment, the medical device comprises a first tissue fixation device at the proximal end and a second tissue fixation device at the distal end. In one embodiment, the device has an axial length of about 10 cm or less, and in one embodiment, the maximum cross-sectional dimension through the device is about 10 mm or less.

  In accordance with another aspect of the present invention, an implant is provided for placement within a patient's body. The implant includes an elongated flexible body having a proximal portion, a central portion and a distal portion. The implant also includes a forming element extending through at least the proximal and distal portions of the body and a removable coupling on the body for releasably attaching the body to the deployment catheter. Operation of the forming element deflects the central portion laterally relative to at least one of the proximal and distal portions.

  In one embodiment, the body comprises a tubular wall. In another embodiment, the tubular wall is substantially incompressible along the first surface of the central portion. The implant comprises a plurality of voids in the wall along the second surface of the central portion, so that the second speed portion can be shortened and extended. In one embodiment, at least some of the voids comprise slots through the wall, and the implant comprises at least 10 transverse slots in the second side wall and at least 20 in the second side wall. With transverse slots. The forming element comprises an element movable in the axial direction. In another embodiment, the forming element comprises a pull wire. In one embodiment, the manipulation of the forming element introduces a first curve into the central portion of the body that is concave in the first direction and into one of the proximal and distal portions of the body that is concave in the second direction. At least a second curve is introduced. In one embodiment, manipulation of the forming element reshapes the body into a “w” configuration.

  A method for manipulating a mitral valve according to another aspect of the present invention, comprising providing a catheter having a prosthesis thereon having a first tissue fixation device and a second tissue fixation device; Inserting a catheter into the venous system and advancing the prosthesis transluminally into the coronary sinus; attaching first and second tissue fixation devices to the wall of the coronary sinus; Manipulating the prosthesis to apply a lateral force on the wall of the coronary sinus between the tissue fixation devices.

  In one embodiment, the method further includes the step of percutaneously accessing the venous system prior to the transluminally advancing step. In one embodiment, this approaching step approaches one of the internal jugular vein, subclavian artery and femoral vein. In one embodiment, the method further includes first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the insertion step. In another embodiment, the method further comprises the step of measuring hemodynamic function following the operating step. In another embodiment, the method further comprises the step of determining the current drug therapy taking into account the post-implantation hemodynamic function.

  In accordance with another aspect of the present invention, a method is provided for applying a therapeutic compressive force to tissue structures adjacent to a vessel wall. The method includes placing the device in a blood vessel and rotating at least one pair of forming elements within the device to move the central portion of the device laterally relative to the proximal and distal portions of the device. Applying force to adjacent tissue structures and deploying the device into a blood vessel.

  In one embodiment, the placing step is performed percutaneously. In another embodiment, the tissue structure includes a mitral annulus. In another embodiment, the tissue structure includes the left ventricle. In yet another embodiment, the blood vessel includes a vein.

  According to another aspect of the present invention, a method for performing mitral valve annuloplasty is provided. The method includes the steps of placing a prosthesis in a curved portion of the coronary sinus, engaging the proximal tissue fixation device and the distal tissue fixation device of the device with tissue on the inner radius of the curve, Manipulating one portion relative to the second portion of the device to apply a compressive force to the inner radius of the curve between the first and second fixation devices and securing the device to maintain the compressive force within the coronary sinus Steps.

  In one embodiment, the method further includes the step of percutaneously accessing the venous system prior to the placing step. In another embodiment, the approaching step is performed by approaching one of the jugular vein, subclavian artery and femoral vein. In another embodiment, the securing step includes engaging the first threaded surface with the second threaded surface. In another embodiment, the securing step includes providing an interference fit. In yet another embodiment, the fixing step includes providing a condensation bond. In another embodiment, the securing step includes providing a ligation. In yet another embodiment, the securing step includes providing a compression fit.

  In one embodiment, the method further includes first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the placing step. In one embodiment, the method further comprises measuring hemodynamic function after the operating step. In yet another embodiment, the method further comprises the step of determining current drug therapy taking into account post-implantation hemodynamic function.

  In accordance with one aspect of the present invention, a method for performing transluminal mitral annuloplasty is provided. The method includes providing a catheter having a prosthesis thereon, inserting the catheter into the venous system, advancing the prosthesis transluminally into the coronary sinus, and at least one tissue Advancing the fixation device from the retracted position to the extended position and manipulating the components of the prosthesis to force the prosthesis onto the mitral annulus.

  In one embodiment, the method further includes the step of percutaneously accessing the venous system prior to the transluminal advancement step. In one embodiment, the approaching step is accomplished by approaching one of the internal jugular vein, the subclavian artery, and the femoral vein. In one embodiment, the method further includes first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the insertion step. The method further includes measuring a hemodynamic function following the operating step. In another embodiment, the method further includes the step of measuring hemodynamic function after manipulating certain components of the prosthetic step. In another embodiment, the method further comprises the step of determining the current drug therapy taking into account the post-implantation hemodynamic function. In another embodiment, advancing the at least one tissue fixation device includes advancing the fixation device in an inclined direction from an axial orientation. In another embodiment, the tissue fixation device has a proximal end for piercing the tissue and a distal point for attaching the prosthesis, and advancing the at least one tissue fixation device comprises: Rotating the fixation device about the attachment point.

  In one embodiment, the method includes advancing at least one tissue fixation device to an extended position. The method may also include advancing at least two tissue fixation devices to the extended position. In one embodiment, the step of manipulating the components of the prosthesis includes a prosthesis in a curved configuration having a first surface facing the mitral annulus direction and a second surface facing away from the mitral annulus. Deform things. In one embodiment, the method further includes advancing at least two tissue fixation devices to the mitral annulus quartz. In another embodiment, the first tissue fixation device is inclined outwardly from the prosthesis and the second tissue fixation device is inclined outwardly from the prosthesis in a proximal direction.

  In another embodiment, the manipulating step includes moving the forming element axially relative to the prosthesis to bend the prosthesis. In another embodiment, the method further includes locking the prosthesis to maintain the force on the annulus after the operating step. In one embodiment, the locking step includes moving the engagement surface from the disengaged configuration to the engaged configuration. In another embodiment, the locking step includes providing an interference fit. In another embodiment, the locking step is accomplished by threaded engagement.

  In one embodiment, the step of monitoring hemodynamic function was performed using transesophageal echocardiography. In another embodiment, the step of monitoring hemodynamic function is performed using surface echocardiography. The step of monitoring hemodynamic function is performed using intracardiac echocardiography, fluoroscopy with a radiographic medium, or left atrial or pulmonary capillary pressure measurement.

  According to another aspect of the present invention, a method is provided for providing a therapeutic compressive force to a tissue structure adjacent to a vessel wall having a first surface and a second surface. The method includes placing the device in a blood vessel, advancing the proximal tissue fixation device from the device to the first surface, advancing the distal tissue fixation device from the device to the first surface, Manipulating the forming element to cause the device to exert a force against the first surface of the vessel wall between the proximal anchor device and the distal anchor device.

  In one embodiment, the placing step is performed percutaneously. In another embodiment, the tissue structure includes a mitral annulus or a left ventricle. In one embodiment, the blood vessel comprises a vein.

  In accordance with another aspect of the present invention, a method for performing mitral valve annuloplasty is provided. The method includes placing a prosthesis in a coronary sinus, rotating a first portion of the device relative to a second portion of the device, and a proximal concave surface that is both concave in the mitral valve direction and Bending the device into an arcuate configuration having a distal concave surface and a concave central concave surface away from the mitral valve to provide a compressive force on the mitral annulus; and an arch in the coronary sinus Securing the device within the configuration.

  In one embodiment, the method further includes the step of percutaneously accessing the venous system prior to the placing step. In one embodiment, the approaching step is performed by approaching one of the internal jugular vein, subclavian artery and femoral vein. In one embodiment, the securing step includes engaging the first threaded surface with the second threaded surface. In another embodiment, the method further comprises the step of measuring hemodynamic function after the rotating step. In one embodiment, the method further includes the step of determining current drug therapy taking into account post-implantation hemodynamic function.

  According to another aspect of the present invention, a medical device for remodeling a mitral annulus adjacent to a coronary sinus is provided. The device is an elongate body having a proximal end region and a distal end region, each proximal end region and distal end region being delivered transluminally to at least a portion of the coronary sinus. And a second remodeling configuration in which each of the proximal end region and the distal end region forms a curve that is open in the direction of the mitral valve. And a forming element for operating the elongate body between a first tubular configuration and a second remodeling configuration.

  In one embodiment, the elongate body comprises a tube having a plurality of transverse slots therein. In another embodiment, the elongated body is transformed into a remodeling configuration by changing the slot width. In another embodiment, the medical device further comprises a coating on the body. In yet another embodiment, the device is movable from an implanted configuration to a remodeling configuration in response to proximal retraction of the forming element.

  In one embodiment, the device is movable from an implanted configuration to a remodeling configuration in response to distal advancement of the forming element. In another embodiment, the device is movable from an embedded configuration to a remodeling configuration in response to rotation of the threaded shaft. In another embodiment, the medical device further comprises a fixation device for holding the device in a deployed position within the blood vessel. In yet another embodiment, the fixation device comprises a distal extension of the device, a surface structure for engaging the vessel wall, or at least one wing for piercing the vessel wall. In one embodiment, the medical device comprises a first wing on the proximal end region and a second wing on the distal end region.

  According to another aspect of the present invention, an implant for placement in a patient's body is provided. In one embodiment, the implant includes an elongated flexible body having a proximal end and a distal end, a longitudinal axis extending therebetween, an opposing first surface extending along the implant body, and A second surface, wherein the first surface has at least one constant axial length portion, and the second surface is offset axially from the constant axial length portion on the first surface. First and second surfaces having at least one axial length portion, at least a first forming element extending through the body to a distal attachment point relative to the body, and the body removably attached to the deployment catheter Removable coupling on a proximal portion of the body for attachment, wherein manipulation of the first forming element comprises a coupling that deflects at least the first portion of the body away from the longitudinal axis.

  In one embodiment, the body comprises a tubular wall. In another embodiment, the implant includes a plurality of voids in the wall along the second surface opposite the constant axial length portion on the first surface, such that the axial length of the second surface. Allows adjustment of height. In another embodiment, at least some of the voids include slots through the wall, and these slots extend generally transverse to the longitudinal axis. In another embodiment, the implant includes at least 10 transverse slots in the second surface wall or at least 20 transverse slots in the second surface wall. In one embodiment, the first forming element comprises an axially movable element or pull wire.

  In accordance with one aspect of the present invention, a system for remodeling a mitral annulus is provided. The system includes a delivery catheter, an implant, and a controller on the catheter. The implant is detachably delivered by a delivery catheter. The implant is reversibly moveable between a first flexible configuration for delivery to a location adjacent to the mitral annulus and a second rigid configuration for remodeling the mitral annulus. is there. A controller on the catheter reversibly deforms the implant between the first flexible configuration and the second remodeling configuration.

  In one embodiment, the implant comprises an arc in the remodeling configuration. In another embodiment, the constant radius curve that best fits corresponding to this arc has a radius in the range of about 10 mm to about 20 mm. In another embodiment, the implant constitutes a compound curve in the remodeling configuration. In one embodiment, the composite curve constitutes a “w” configuration.

  In one embodiment, the system further comprises a coating on the implant. In another embodiment, the system further comprises a fixation device for holding the implant in the deployed position. In one embodiment, the fixation device comprises a distal extension portion of the implant, a friction enhancing surface for engaging adjacent tissue, or at least one wing for piercing the vessel wall. In one embodiment, the wings are movable between an axial orientation and a tilted orientation.

  Other features and advantages of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of the preferred embodiment and considered in conjunction with the accompanying drawings and claims.

Detailed Description of Preferred Embodiments
A preferred embodiment of the present invention is a method for performing mitral annuloplasty and remodeling the left ventricle using a device that is introduced percutaneously into the coronary venous system of the heart. And equipment. This device applies a compressive force on the mitral annulus and the left ventricle to reduce the severity of mitral regurgitation and the size of the left ventricular cavity. Thus, this device allows for mitral annulus reduction and left ventricular cardiac dilation constraints, but without the mortality and other risks associated with open thoracic surgery. Other details are disclosed in parent application No. 10 / 066,302, filed Jan. 30, 2002, the disclosure of which is incorporated herein by reference in its entirety.

  The inventor of the present invention repositions the mitral annulus by placing an endovascular prosthesis or implant because the coronary sinus and vein are located adjacent to the mitral annulus and ventricular septum Decided to provide an ideal conduit. As used herein, “implant” is a broad term and is not limited to a permanently introduced structure or device, but may be a temporarily introduced device. The coronary sinus is contained within the atrioventricular groove and is proximate to the posterior, lateral and anterior sides of the mitral annulus. The coronary sinus and jugular vein are currently intubated when performing any of a variety of percutaneous transvenous diagnostic and therapeutic procedures. It is safe and well tolerated to place the pacemaker or defibrillator lead permanently in the coronary sinus.

  The annuloplasty system consists of several components. Desirably, there is a delivery system intended for percutaneous introduction into the central vein. The implants of the present invention are deployed from a delivery system, preferably a delivery catheter, into the coronary venous system, or within the myocardium or adjacent to the myocardium (to affect the mitral annulus). An additional tool is placed through or along the delivery catheter, placing the device in place, applying the element in place as described in detail below, and applying a tensioning element (if provided) ) And / or disconnect from the delivery system.

  Referring to FIG. 1, there is shown a schematic diagram of a heart 10 with a mitral annuloplasty and cardiac reinforcement device 40 of a preferred embodiment disposed therein. The heart 10 generally includes a right atrium 12 that communicates with the superior vena cava 14 and the inferior vena cava 16. The left ventricle 18 is positioned below the left atrial appendage 20. The relevant portion of the coronary vasculature comprises a coronary sinus 22 that extends from the ostium 24 to the junction 26 of the coronary sinus and the great cardiac vein 28. An anastomotic connection 29 exists between the major heart vein 28 and the middle heart vein 30 as is well known in the prior art.

  One embodiment of the mitral annuloplasty and cardiac reinforcement device 40 is shown generally within the coronary sinus 22. In particular, the device 40 extends from the proximal end 42 to the distal end 44. The proximal end 42 is adjacent to the posterior side of the atrial spacing membrane 46. An intermediate portion 48 of the device 40 is located within the coronary sinus 22. The transition portion 50 of the device 40 resides at the junction 26 of the coronary sinus 22 and the great heart vein 28. The distal end 44 of the device 40 is inserted into the great cardiac vein 28.

  The transition region 50 is designed to be in the proximal portion of the great cardiac vein 28. This region serves as a fixation device 52 by deflecting from the plane defined by the coronary sinus 22 and prevents the device 40 from sliding out of the coronary sinus 22 when tension is applied. This embodiment of the fixation device 52 is preferably very relaxed and flexible so that the risk of the device 40 being eroded by the great cardiac vein wall or other aspects of the coronary venous system is minimized. Limit. The proximal end 42 of the device 40 resides outside the ostium 24 of the coronary sinus 22 and preferably faces upwards in a curvilinear manner so as to be fixed adjacent to the posterior side of the atrial spacing membrane 46. Advantageously, the proximal end 42 of the illustrated device 40 is a semi-circular shape and an elliptical profile, and the edges do not promote erosion of adjacent tissue.

  Any of a variety of structures can be provided as a fixation device 52 as an alternative to the distal extension of device 40. In general, deployment device 40 contacts the wall of coronary sinus 22 along the inner diameter of the arcuate path. Accordingly, the tissue contacting surface 54 on the concave surface of the deployment device 40 may be provided with any of a variety of friction surface structures, such as a plurality of transverse ridges, teeth or other protrusions, or a modified surface texture to enhance friction. Provide. Alternatively, a tissue engaging or piercing structure, such as a wing, is provided on the surface 54 and engages the wall of the coronary sinus 22 to resist movement of the device 40 as described below.

  Although the use of a structure such as a fixation device provides some benefit for certain applications, the embodiments illustrated and described herein operate in particular without such positive tissue engagement, Certain embodiments may be particularly useful. For those skilled in the art, the disclosure of the present invention allows embodiments of the present invention to provide independent device operation and shape control, allowing sufficient force to be applied to the mitral valve, and for the remodeling process, Obviously, it does not require the detrimental effect of perforating and grasping tissue within it. In some respects, the individual effects of unfeathered structures can be adjusted in both tension and relaxation directions, reducing the risk of significant tissue damage or erosion. In other respects, the device 40 according to at least certain embodiments advantageously maintains its length throughout the shape modification range, but the sinuses and adjacent annulus reduce the dimensions subjected to the remodeling force. In yet another point, the independent operation and non-operation of the tissue drilling and grasping device allows the device to be placed in the sinus for the first time, for example if complications occur or the patient is turned into surgery. For example, it can be removed from the patient in applications intended to provide temporary therapeutic treatment. Further in this regard, depending on the response observed in vivo to the implant, devices of various shapes and sizes are required for a particular patient before finding a suitable device.

  The specific dimensions, structural details and materials of the mitral annuloplasty and cardiac augmentation device 40 may vary widely as those skilled in the art will appreciate upon considering the disclosure herein. For example, dimensional adjustments can be made to accommodate different anatomical sizes and configurations. Details of materials and structures can be altered to accommodate different tensioning mechanisms and other considerations.

  In general, device 40 defines an overall length from proximal end 42 to distal end 44. Preferably, this length is in the range of about 2 cm to about 10 cm in an embodiment as shown in FIG. 2 in which the fixation device 52 comprises a distally extending portion of the body 66 that is inserted into the great cardiac vein 28. is there. One embodiment of the device 40 comprises an elongated flexible body 66 that is approximately 8 cm in length. In such an embodiment, the body 66 may have an elliptical cross-section so that it will be bent in a single plane when a force is applied to the tensioning element in the body 66, as described below. Device 40 tapers distally and transitions to a rounded cross section.

  2A-B, one embodiment of a device having a forming element 56 such as a wire therein is shown. By manipulating the forming element 56, the device can be inserted percutaneously into the vasculature and navigated into the coronary sinus (FIG. 2B) from the mitral valve. It is possible to move to an arcuate configuration (FIG. 2A) that compresses at least a portion of the annulus. Device 40 is advanced from the first flexible configuration to the second arcuate configuration by axial proximal retraction or distal advancement of the forming element relative to body 66 depending on the particular configuration.

  Generally, the device 40 comprises a flexible support 58 that extends from the proximal end 42 to at least the location of the connection mechanism 60. The support 58 may be part of the body 66 or may be a separate component as described below. The support 58 has a fixed length and is substantially incompressible and non-expandable in the axial direction. Thus, proximal axial retraction of the forming element 56 with respect to the proximal end of the support 58 desirably causes the support 58 to deflect in a first direction and the body about an axis transverse to the longitudinal axis of the body 66. 66 is bent. Distal axial advancement of the forming element 56 relative to the support 58 deflects the support 58 laterally in the second direction, and the body 66 is straightened by the inherent elasticity of the support 58. The basic steering configuration can be implemented in many forms and can be optimized by one skilled in the art to adapt to the particular structure of the body 66 depending on the desired dimensions and clinical performance.

  Forming element 56 extends from proximal end 42 through device 40 to the location of connection mechanism 60. In the position of the connection mechanism 60, the forming element 56 is mechanically coupled to the support 58, preferably directly coupled. Alternatively, any other suitable method of connection mechanism may be used. A proximal extension portion 64 of the forming element 56 extends from the proximal end 42 of the device 40, for example, through the aperture 62. Proximal retraction of the forming element through the aperture 62 causes the device 40 to bend from the implantation or delivery direction and navigate to the coronary vasculature or remodeling direction upon implantation to coronary sinus 22 and adjacent structures. Compress and restrain.

  Device 40 preferably provides a compressive force against the mitral annulus as described above in the formation, remodeling orientation. This is desirably accomplished by forming the device in an arcuate configuration. In general, the best-fit curve of constant radius that the formed device will fit has a radius in the range of about 1.0 cm to about 2.0 cm. The forming elements can be a variety of materials and structures, such as polymers or metal wires or strands, multi-fiber braid or woven lines, metals or polymer ribbons, or others that can hold the device 40 in tension in the coronary sinus 22. Including any of the following structures.

  Device 40 further includes a support 58, which is a separate element disposed within or within body 66 of device 40. In embodiments in which the support 58 is a separate element contained within the device 40, the support 58 may be a variety of generally axially incompressible elements such as metal or polymer wires or struts, ribbons, or “minimum” It includes any of the “in position” (eg, fully compressed) springs, which facilitate lateral bending, but prevent axial compression after proximal retraction of the forming element 56. Metal ribbons including stainless steel, nitinol, or other known materials are desirable in certain embodiments due to their ability to affect the curved plane of device 40 in the forming orientation.

  In the presently illustrated embodiment, the proximal extension portion 64 of the forming element extends proximal to the entire length of the deployment catheter to a control device or free end that remains outside the patient's body during the deployment procedure. After placement of device 40 in the coronary sinus, proximal traction on proximal extension portion 64 causes device 40 to be coronary sinus as described below in connection with the method of use of the preferred embodiment. It is reconfigured in the inner formation direction. After sufficient tension has been placed on the coronary sinus 22, the forming element 56 is preferably locked in a fixed axial position relative to the device 40, so that the forming element 56 moves distally through the aperture 62. Resist. A variety of suitable locking configurations can be provided. Preferably, the lock 70 is provided on or near the proximal end 42, in particular at or around the aperture 62. The lock may be any of a variety of structures, such as suture ligatures, lock clamps or rings, interference fits, ratchet and pawl structures, threaded engagement, condensation coupling, or as will be apparent to those skilled in the art upon consideration of this specification. Consists of compression mounting.

  The lock 70 (in any of the embodiments herein) is first disengaged so that the forming element 56 can freely retract or advance through the aperture 62 when the physician Adjust 40 tensions. When the desired tension is achieved, the lock 70 is activated and engages the forming element in a manner that depends on the structure of the lock. Alternatively, the lock 70 is biased into the engaged configuration, for example by a ratchet or cam structure, so that the forming element can only be retracted proximally. Preferably, however, the lock allows the forming element to be released, so that the physician 40 can release the tensioned state of the device 40 if momentarily over-tensed.

  Forming elements 56 and 58, with or without the tubular body described below, are polyester fabrics such as ePTFE, or DACRON, or others wound or sewn onto forming element 56 to form the final device 40 Surrounded by a tubular jacket. As another alternative, the forming element 56 and, if present, the subassembly including the support 58 is placed in an appropriately length tube formed by extrusion or the like. The tube is pulled down to a reduced diameter at the distal end 44. Other steps after extrusion are used to form the desired cross-sectional configuration. The manufacturing techniques of the present invention will be apparent to those skilled in the art from consideration of the disclosure herein.

  Various other features may be added to the device 40 depending on the desired clinical performance. For example, the outer surface of the body 66 softens the surface with various coatings, heparin or other antithrombotic agents to improve lubricity, such as poly-paraxylene, PTFE or others marketed under the trademark PARALENE, Elastomers such as silicone, neoprene, latex or others are provided to reduce the risk of trauma to vascular intima and the like. Tack-enhanced surfaces, such as ePTFE patches or jackets, are formed to promote cell ingrowth and anchor for long periods of time. Further, depending on the configuration of the deployment system, the body 66 is formed with a guidewire lumen extending axially through the body 66, the body 66 over the guidewire when placed in the treatment position. Can be advanced distally.

  The device 40 may be accessed through a direct surgical procedure (eg, thoracotomy with or without a sternotomy), or percutaneous or surgical cutting, such as in combination with another surgical procedure through the port. Due to the approach to the venous system, it is implanted in the coronary sinus 22. Preferably, device 40 is implanted in a transluminal procedure, such as by percutaneous access in one of the internal jugular vein, subclavian artery or femoral vein.

  3-8B illustrate an exemplary device assembly 200. FIG. In general, FIG. 3 is an overall view of an assembly comprising a supply assembly 210 that engages a prosthesis or implant 250. According to similar overall delivery systems and methods described herein, the prosthesis 250 is at least partially delivered intravascularly in a first condition and shape by manipulating the supply assembly 210. Configured as follows. In the desired region of the target vessel, the prosthesis 250 is configured to be adjusted according to the second condition and shape within the vessel to affect adjacent tissue structure. Also, as described herein, this particularly useful mode of surgery may affect the mitral valve annulus, and more particularly, affects the shape of the annulus to prevent mitral valve regurgitation. To reduce, a prosthesis 250 is placed in the coronary sinus.

  FIGS. 4-7 illustrate a supply assembly 210 that includes a proximal surface of the device assembly 200, particularly an outer member 215 that is preferably tubular, and a lumen 216 that is preferably sized to receive the inner member 225. Various details are shown. The inner member 225 in the illustrated variation is generally tubular and preferably rotates substantially freely within the lumen 216 by providing a rotational force proximal to the inner member 225 outside the patient's body. . According to the illustrated embodiment, this rotational force is applied to the inner member 225 through a thumb wheel 205 provided on the proximal hub assembly 201 coupled to the proximal end portion 211 of the supply assembly 210. . The thumbwheel 205 is rotatably coupled to the inner member 225 in the hub assembly 201, and such rotational coupling is accomplished by a number of modification methods that will be apparent to those skilled in the art.

  The rotation of the inner member 225 is transmitted to the rotation of the rotating coupler that engages within the proximal end portion 252 of the prosthesis 250 as follows. The inner member 225 has an aperture 228 on its distal end portion that forms a female counterpart of the mating key interface between the inner member 225 and the female counterpart. The corresponding portion is desirably provided by the formed proximal end 281 of the rotary coupler 280 that also rotatably engages within the proximal end portion 252 of the prosthesis 250. The key attachment between the inner member 225 and the rotary coupler 280 allows the rotational force to be transmitted to the rotary coupler 280. To maintain such releasable axial engagement of the key coupling, a flexible member such as filament 240 is looped from aperture 283 to the proximal end 281 of rotary coupler 280 and both filament ends 242 and 244 are passed. Extends proximally through the inner member 225 to the location of the proximal end of the catheter. Filament 240 generally remains sufficiently tensioned to maintain the engagement of the distal key coupling, but the presence of the filament provides a sufficiently tight tolerance at the male / female interface of the key coupling. If present, prevents dissociation.

  The rotary coupler 280 is rotatably engaged into the proximal end portion of the prosthesis 250 through the proximal port or aperture 251, and the rotary coupler rotates within the prosthesis 250 or to the prosthesis 250. It is comprised so that it may rotate with respect to it. These relative rotations are converted to force the deflection of the prosthesis 250 at the current position to the desired shape of the second configuration as follows.

  According to one aspect of the rotational coupling, the prosthesis 250 is preferably held to resist rotation, and the rotary coupler 280 rotates within the prosthesis 250. This is accomplished simply by the frictional force of the surrounding tissue after the prosthesis 250 has been delivered into the desired vessel, such as the coronary sinus. According to another embodiment, this is accomplished by providing a releasable interface, such as a friction fit, between the outer member 215 and the proximal end portion 252 of the prosthesis 250, the outer member 215 and the prosthesis. The frictional engagement with the object 250 is held at a relatively constant position, and the inner member 225 and the rotary coupler 280 rotate. This embodiment is shown in FIG. In addition to or instead of the friction fit interface, a key interface is used as shown in FIGS. According to this method, the proximal mating portion 253 formed on the proximal end 252 of the prosthesis 250 is within the forming aperture or mating portion on the distal end 212 of the outer member 215 as a male counterpart. Configured to mate. This key interface allows rotational coupling between the parts in a manner similar to that described above with respect to the inner member 225 and rotary coupler 280, and when the member is removed axially, friction is reduced and relatively released. Possible combinations are possible.

  The rotational force from the rotary coupler 280 is converted into a deflection force on the prosthesis 250 according to one embodiment shown in FIGS. Prosthesis 250 includes a generally tubular wall or body 260 having a lumen 262 and extends from a proximal end portion 252 to a distal end portion 254 of the prosthesis 250. Along the proximal end portion 252, a nut fit 263 having a grooved inner bore 264 in communication with the lumen 262 is secured. In addition to this particular embodiment, the rotary coupler 280 is a threaded member with an outer helical thread 285 engaging within a mating thread on the inner surface of the bore lumen, the distal portion of the thread 285 being: Ends at a second key fitting 287 that extends distally into the lumen 262 and resembles the molded proximal end portion 282 and also has an aperture 288. Similar to the proximal end of the rotary coupler 280, another flexible member or filament 290 is looped from the aperture 288 and the two arms 292, 294 are distal to the prosthesis 250 from the aperture 288. Extends distally along end portion 254 to the connection point. The nut fit 263 is fixed relative to the outer tubular body 260, the tubular body being held in a relatively fixed position as described above, and the rotation of the rotating coupler 280 causes the coupler 280 to move closer to the body 260. Move to the place. Such proximal axial translation of the rotary coupler 280 places tension on the filament 290 and, as a result, tensions on the body 260 by a distal connection mechanism. Such tension on the outer body 260 deflects the body 260. Thus, the rotational force is converted to tension, resulting in a radial deflection of the body 260 relative to the longitudinal axis L of the device 250. That is, the body 260 deflects around an axis that intersects the longitudinal axis L. See FIG. 8B.

  The forced deflection described above can be controlled in a particular plane by providing a composite structure within the prosthesis 250 that is designed to react to, or yield, such forces in a defined manner. In the particular embodiment shown, a relatively incompressible strut support or spinal member 270 is provided within the lumen 262 of the tubular body 260. This spine member 270 is stiffer than the material of the outer tubular body 260 alone and resists axial forces, particularly tension. Thus, providing the spinal member 270 along only one radial position along the periphery of the prosthesis 250 creates a bias on the device 250 and moves away from the spinal column 270 toward the more compressible region direction of the device 250. To deflect. Such a composite structure further comprises a composite structure, such as a laminated structure, an embedded wire reinforced wall structure, or is designed along the outer tubular body 260, for example to another region, by designing a deformation of the device material. This is accomplished by thinning, thickening, curing, or softening the material at the location to deflect the body 260 at the desired location.

  As achieved by the other controllable embodiments described herein, the deflection according to embodiments of the present invention is adjusted according to the needs of the health care provider and tightens the radius of curvature R or curvature. It can be adjusted in either direction by opening the radius R. See FIG. 8B. However, according to this particular embodiment, the adjustability of the deflection tension and relaxation options depends on the direction and extent of rotation arranged in the rotational force transmission system.

  Once the desired deflection has been achieved and the desired treatment result has been observed, the prosthesis 250 can provide a delivery assembly by cutting the torque or torque transmission system at the key connection between the inner member 225 and the rotary coupler 280. 210 can be removed. This first releases at least one arm 242, 244 of the proximal filament 240 and pulls out the other arm, thereby passing the filament 240 out of the aperture 283 (as shown by the thick arrow in FIG. 8B). ), By completely pulling out from the aperture 283. As a result, the inner member 225 is withdrawn proximally from the rotary coupler 280 to separate the prosthesis 250 and thereby implant the prosthesis 250.

  Alternatively, like the other adjustable deflection systems described herein, the prosthesis is held in its treatment state for a temporary period (but may be extended upon admission), while In addition, mitral regurgitation is minimized for the purpose of delivering the patient in a temporarily improved state until other treatments such as annuloplasty, valve surgery, heart transplantation, etc. are performed. These alternative temporary settings, when appropriate, adjust the deflected and contracted prosthesis back to the open position from the clamped position around the valve, and then the delivery assembly is still engaged with the prosthesis. By pulling out the combined system, it was pulled out without being embedded. Further, such temporary prostheses can be modified to remove the detachment mechanism described herein to provide a simpler and lower cost device.

  The device assembly 200 is also shown in FIG. 3 and FIGS. 8A-B as including a distal guidewire tracking member having a guidewire lumen 265 that includes a guidewire lumen 265. 230 is configured to slidably engage 230 and be placed in a percutaneous transluminal procedure within a desired vascular location, such as within the coronary sinus 22. The particular guidewire lumen shown is integral in the distal face of the prosthesis 250 as a “quick exchange” or “monorail” structure, allowing for relatively independent movement of the guidewire and catheter in vivo. To do. Furthermore, this structure travels coaxially through the entire device assembly 200, as seen in the “over the wire” system embodiment. The type shown advantageously allows the prosthesis 250 to be removably engaged, preferably after the optional guidewire 230 has been withdrawn from the distal lumen 265.

  In each of the above implantation methods, the physician preferably monitors the degree of reflux in the step of tightening the implant. Although a reduction in mitral regurgitation is desirable, it is preferred that the reflux be reduced somewhat below moderate (less than 2+). In any case, it is preferable to achieve at least one grade reduction. On the other hand, it is desirable not to reconstruct the implant 250 to a degree sufficient to cause mitral stenosis or to a degree where hemodynamic flow restriction is significant.

  Accordingly, the implantation preferably further includes monitoring the degree of mitral regurgitation during the implantation and / or reconfiguration steps and preferably also before and after these steps. The degree of mitral regurgitation, as understood in the prior art, during step-limiting steps of the mitral annulus and / or left ventricle, step transesophageal echocardiography, intracardiac echocardiography, Monitor by fluoroscopy using radiography (LV grams) in the left ventricle, or by evidence of left atrial or pulmonary capillary wedge pressure. Once the physician determines that a sufficient reduction in the backflow of a particular patient has been achieved, the device 250 is locked and the supply assembly 210 is separated from the device 250 and removed from the patient.

  The method further includes measuring coronary sinus 22 and / or other arterial veins and selecting an appropriately sized implant 250 from an array of various sized implants. These parameters include the diameter, length or radius of curvature of the sinus arc. Accordingly, the implant 250 is preferably provided in a step-wise arrangement of sizes so that the optimal size can be selected for each patient. The size of the coronary sinus 22 or other veins can be measured using an echo heart rate curve, MRI, CT scan, or angiography well known in the prior art. Further, as will be apparent to those skilled in the art, the measurement of the parameters of the coronary sinus 22 provides an indication of the specific parameters of the mitral valve and its annulus, such as the diameter of the mitral valve, in which case the coronary Both sinus parameters or mitral valve parameters provide the information necessary to select an appropriately sized device 250 from the kit.

  These mitral valve parameters can also be directly measured by the various methods described above to generate values that are used to select the appropriate device 250. As described herein, after measuring the parameters of the anatomical features, the values are approximated according to the accuracy of the individual measuring instrument, which has no special medical skills or training. It is intended that a person who has not received this approximate value as a weapon can select an appropriate medical device 250 from the kit. For example, the package of each device 250 of the kit may indicate individual dimensions unique to the device 250 relative to the other devices of the kit, and a simple comparison of measured anatomical parameter estimates may be made.

  Various embodiments described herein are configured to manipulate the coronary sinus 22 to reduce the mitral annulus without substantially changing the length of the device 250 within the sinus 22. Is done. As a result, if the sinus length and / or ring diameter is reduced during remodeling from the radial deflection of the prosthetic device 250, the device 250 along the coronary sinus 22 can be Benefits can be gained by increasing the effective procurement of devices 250 at This also means that the dimensions of the device 250 in the device kit do not directly correspond to the approximate value of the anatomical parameter to be measured. For example, the measured device parameter control value may be shorter than the estimated coronary sinus 22 due to the possibility of the sinus 22 being shortened during treatment of the device 250. Alternatively, anatomical parameters are estimated from treatment or estimated from initial values based on the desired end result, and these procedurally relevant values are used to select an appropriate device (e.g., live When used in the body, the approximate final length of the diameter of the sinus or mitral valve is compared to the known dimensions of the device in the remodeling configuration).

  As yet another aspect of the present invention, the implant 250 is preferably combined with a suitable drug therapy for treating congestive heart failure. Residual reflux and other hemodynamic functions are preferably measured after implantation of the implant of the present invention. Cardiac medication is preferably adjusted to account for reduced reflux and / or reduced left ventricular volume when prescribing current medication to the patient.

  In addition, the present invention contemplates temporary use in the sinus 22 for mitral valve remodeling as an intercellular bridge system associated with relatively conventional annuloplasty or valve replacement by surgery. Such a coupling system of device 250, and further individual use methods coupled to the drug system, can provide a very beneficial result in terms of managing patients with adverse mitral regurgitation. Provide a treatment system.

  All embodiments described herein are provided with one or more conductive strips or annular bands that are electrically conductive opposite the outside and extend axially, so that the device 40 can be used for cardiac adjustment or other purposes. Allowing it to further function as a diagnostic or therapeutic cardiac electrode. The one or more conductive bands are electrically coupled to the cardiac conditioning source or diagnostic instrument by one or more conductors extending away from the device 40. This conductor is electrically connected to any of a variety of electrical heart rhythm management devices, such devices are well known in the prior art.

  As shown in one embodiment of FIGS. 9A and 9B, in the coronary sinus, the elongated body 320 is configured to remodel the mitral annulus from a first implant (flexible) configuration. And is configured to be adjusted to a second (relatively rigid) remodeling configuration having a shape. According to the embodiment shown in FIG. 9B, this shape as a whole is, for example, at least partially grasped up to a portion around the periphery of the valve, and the circular shape shown to provide a reducing force on the diameter. Is configured to apply an external force to reduce the diameter along at least one transverse axis. Also, as shown in the virtual diagram, the arc shape may take different forms, and in other very useful applications it can be controlled and selected between different degrees or across a range of consecutive degrees It is. Such controllability according to the illustrated embodiment is also selectable between the Chinese and Korean deflectable portions 360, 370, as shown in FIG. 9B and described in detail below.

  The elongate body 320 is constructed from a tubular wall 325 that extends continuously along the length of the deflectable portions 360, 370 of the elongate body 320. A row or plurality of discrete discontinuous slots or voids 330 are formed in the wall 325, each void 330 having an elongated shape transverse to the longitudinal axis. The gap 330 shortens the axial direction of one side of the tubular wall 325 and allows the curvature shown in FIG. 9B.

  Further, referring to the particular embodiment of FIGS. 9A-F, the transverse gap 330 has a central channel region where adjacent portions 332, 334 converge at the apex 333 along the longitudinal axis. . The void 330 thus formed is defined at least in part by two opposing complementary formed surfaces of two adjacent longitudinally opposing portions 340, 350 in the wall of the elongated body 320. Is done. One of these portions 340 has a convex shape in the axially distal direction, and the other portion 350 around the apex 333 is preferably concave in the axially proximal direction. The surfaces 340, 350 thus formed are preferably of a nested configuration in which the convex portion 340 is disposed within the concave portion 350. In this configuration, lateral (rotational) movement of adjacent wall portions 340, 350 relative to one other portion 340, 350 is substantially prevented by a mechanical interface with the other adjacent portions 340, 350. The relative nesting of adjacent portions 340, 350 of the elongated body 320 provides mechanical interference for radial deflection along the first plane, and after the axial bending force is applied, the second plane Substantially isolates the deflection of the elongated body 320 along the axis.

  FIG. 9D shows the grooved gap 330 in a plan view to simplify the illustration and make it easier to understand. However, as shown in FIG. 9C and with reference to FIG. 9E, these transverse gaps 330 (and substantially the entire V-shaped portion described in detail herein) are at least about the periphery of the elongated body 320. Spread 180 degrees. Preferably, the transverse gap 330 extends beyond about 300 degrees around the elongate body 320, and more preferably, the gap extends between about 300 degrees to about 315 degrees around the circumference. By arranging these grooved voids in similar alignment around the wall 325, the integral and continuous spine or spine 327 is along the wall 325 that runs axially along the length of the elongated body 320. It is formed. It has been observed that this overall arrangement of the void 330 and spine 327 provides the desired combination of bendability due to the void pattern and axial integrity, and the remaining wall structure.

  The elongated body 320 of the implant 300 shown in FIGS. 9A-F generally has three deflectable portions 360, 370, 380 and a non-deflectable portion 310 along the longitudinal axis. Each deflectable portion 360, 370, 380 has a group of voids 330 as described above, and applies a force from outside the patient's body to place the elongated body 320 in the coronary sinus. It is possible to individually deflect between the first configuration and the second configuration. In particular, the three forming elements 365, 375, 385 are coupled to the three deflectable portions 360, 370, 380, respectively, to reshape the portions between the first and second configurations. A deflection force is given to the part. Each forming element 365, 375, 385 is manually manipulated to place the elongate body 320 within the coronary sinus and provide deflection forces to the individually coupled deflectable portions 360, 370, 380. Sometimes configured to extend outward from the patient's body. The deflection of each of these combined portions provides for the overall shape of the elongated body 320 of the second configuration.

  Forming elements 365, 375, 385 are attached to the elongate body 320 at characteristic longitudinally distant positions of the connection mechanisms 361, 371, 381, respectively, each connection mechanism having a respective deflectable portion coupled thereto. Present at the distal end of 360, 370, 380 or distal to the distal end. One useful application is shown with respect to the connection mechanism of the forming members 365, 375, 385 to the body 320, where each position of the connection mechanisms 361, 371, 381 includes two axially spaced apertures. These apertures are shown as proximal and distal apertures 362, 363 at the location of the connection mechanism 361, and as proximal and distal apertures 372, 373 at the location of the connection mechanism 371, In the location of the connection mechanism 381, it is shown as proximal and distal apertures 382, 383. The shaped distal end 377 of the forming element 375 is sized to seat within the distal aperture 373, as shown in the location of the connection mechanism 371 in FIG. It is fixed in the aperture 373 by a binder or solder. The individual forming elements 365, 375, 385 are all joined to the wall through the aperture. The forming element 375 extends proximally from the distal aperture 373 and is further secured to the wall 325 by an additional fixative 374 introduced from the proximal aperture 372. Furthermore, the distal end 37 is also shaped to provide a mechanical securing means to the connection mechanism when a proximal axial force is applied, as shown in the phantom view of FIG. 9F.

  According to one particular embodiment that has been observed to be useful, the aperture for this connection mechanism embodiment is typically about 0.020 inches to about 0.022 inches in diameter, and the longitudinal feel is Similar, the distal end of the seated forming element is about 0.012 to about 0.014 inches in diameter. In addition to this embodiment, the wall 325 is generally comprised of a tubular stainless steel wall or hypotube, the interior of which is shown and described in FIG. 9D or described elsewhere herein. A plurality of grooved voids 330 are formed according to a pattern similar to the pattern being formed. In addition to this embodiment, the grooves shown and described in FIG. 9D were formed in the underlying stainless steel tube by laser cutting, but other well known techniques such as manual gripping, mechanical cutting, photolithography Can be used instead.

  As noted above, the forces applied from the forming elements 365, 375, 385 are generally against the elongated body 320 and a proximal position (not shown) along the elongated body 320 proximal to the deflectable portion. It is the force in the axial direction of the position 361, 371, 381 of the connection mechanism. According to the particular embodiment shown, this force is generally between the connection mechanism location 361, 371, 381 and the proximal end portion of the elongated body 320. The elongated body 320 is generally held to substantially secure the proximal end portion of the elongated body 320 relative to the deflectable portion upon forced deflection by a holding device (not shown), so that An axial force is applied between these parts at the current position. Proximal manipulation of the forming element 320 to apply a deflection force to the deflectable portions 360, 370, 380 is axial as described above, but may otherwise be a rotational force.

  Each deflectable portion 360, 370, 380 is substantially axially rigid and incompressible with respect to the longitudinal axis, so the overall axial length of the elongated body 320 is It remains substantially constant between the first configuration and the second configuration. However, each deflectable portion is relatively flexible along a radial axis transverse to the longitudinal axis, so that the deflectable portion is a distal position of the elongated body, An axial force is applied between the distal end of the deflectable portion or a position distal to the distal end and a proximal position along the elongated body 320 proximal to the deflectable portion. When configured, it is configured to bend in the radial direction. In some respects, the elongated body 320 is axially incompressible or non-expandable between each deflectable portion 360, 370, 380 and the proximal end portion of the elongated body 320; Each deflectable portion 360, 370, 380 has a compression or tension axis respectively between a distal position of the elongated body 320 and a proximal position that is the proximal end portion of the elongated body 320. It is configured to bend in the radial direction after the directional force is applied.

  Also, in other respects, other configurations of the elongated body 320 are controlled with respect to an integral and continuous wall 325 from the proximal end portion to the distal end portion of the body and axial compression force or tension. Prepare for combination with radial bending reaction. Further, in addition to or instead of a continuous monolithic wall that incorporates the formed void 330, the wall 325 is an engineered composite support structure that includes an engineered support element that provides an applied force. A support structure is also provided that is arranged to control the spatial strain response to stress. Other suitable shapes for the gap 330 are also acceptable.

  A gap patterned according to the embodiment of the nested V-pattern (or U-pattern) shown in FIGS. 9A-F is shown in FIG. Interfacing surfaces 342, 352 having the teeth are configured to lock into the second configuration in a radially deflected pattern. Specifically, the interface pattern of teeth 344, 354 is configured to operate in a ratchet mechanism. By placing this region along the inner radius of curvature during forced deflection bending, the compressive force fits the convexly shaped tooth region 340 formed by the concave containment region 350. Feed deeper into the well. This movement provides interference with the teeth 344, 354 to deflect the portion 340 and move further in the direction of the portion 350 to remove the teeth 354 and recover to lock the teeth 344 after the 354. The interaction movement of the adjacent part in the region having the void is further represented by a thick arrow in FIG. 9G.

  FIG. 10 illustrates another configuration of a medical device 400 configured to place an implant 402 or prosthesis in a coronary sinus or other treatment site. Similar to the embodiments described above, the medical device 400 includes a handle assembly 404 at the proximal end, while the implant 402 is located at the distal end. Handle assembly 404 and implant 402 are connected by an elongated flexible catheter body 406. Desirably, the body 406 is or includes an extrudate of material that has sufficient strut strength, i.e., resists axial compression, but the body 406 can bend radially. . Any of a variety of polymers well known in transluminal catheter technology, such as HDPE or PEBAX, can be used to form the body 406. However, other suitable materials may be used. In one embodiment, the body 406 has an outer diameter of about 0.094 inches.

  Referring to FIG. 11, a plurality of lumens or passages extend axially along the catheter body 406. The extrudate shown includes three lumens 408, 410, 412 and one relatively large lumen 414. Small lumens 408, 410, 412 are disposed substantially in one half of the circular cross section of body 406, each circular cross section having an inner diameter of about 0.024 inches. The relatively large lumen 414 is desirably disposed within substantially half of the circular cross section of the body 406 opposite the small lumens 408, 410, 412 and has a diameter of about 0.044 inches. Overall, lumens 408, 410 and 412 of medical device 400 extend from control assembly 400 (eg, forming elements 365, 375, 385 of FIGS. 9A and 9B) from handle assembly 404 to implant 402. , Allowing it to be protected within the shaft 406. Alternatively, the desired number of pull wires can provide only a single pull wire lumen, or two pull wire lumens, as required. As described in detail below, the control component translates the operable movement of the handle assembly 404 into the resulting desired movement of the implant 402. The relatively large lumen 414 is used to rotatably accommodate the driver 436 as described below. In addition, one or more lumens are used to enable coronary sinus irrigation, drug or contrast agent injection, or other desired purposes.

  Referring to FIGS. 12 and 13, the implant 402 is shown in more detail. 13 is an enlarged view of a portion of FIG. 12, showing the releasable connection between the supply assembly 401 and the implant 402. FIG. As described above, since the implant 402 is removably connected to the supply assembly 401, the supply assembly 401 and the implant 402 are suitable for insertion into a coronary sinus or other body lumen or hollow tissue. After being placed and tensioned, it comes off.

The implant 402 defines a body portion 416 that is preferably tubular in shape with at least one central lumen extending through the body portion. The total length of the implant 402 can vary depending on the intended treatment site and the desired clinical performance. In certain applications intended to place the device in the coronary sinus and reduce the diameter of the mitral annulus across a predetermined plane, the implant 402 is generally within the range of about 5 cm to about 15 cm. Is the length of For most adult patients, an axial length in the range of about 6 cm to about 12 cm is used. In one embodiment, the implant 402 is about 9 cm long and has a cross-sectional area of about 15 mm ² or less. Preferably, the implant 402 has a cross-sectional area of about 10 mm ² or less.

  The implant can be composed of materials similar to those described above, such as stainless steel, nitinol, or other known materials suitable for implantation. An atraumatic distal tip 418 is provided on the distal end of the body portion 416. Because the front end of tip 418 is rounded, atraumatic tip 418 does not cause significant tissue damage when advanced through the patient's vasculature.

  A nut 422 or other structure having a threaded aperture therein is provided at the proximal end of the body portion 416. Desirably, the nut 422 is fixed axially and rotationally relative to the body portion 416. For example, in the illustrated embodiment, the outer edge of nut 422 is circular with a flat portion 464 on one side to form a keyway 481 for pull wire 458 and is sized to fit within body portion 416. Provided. The nut 422 is thermally bonded to the main body portion 416 to form a key groove 481. Of course, other suitable configurations can be used to prevent relative rotation between the nut 422 and the body portion 416, such as other mechanical interference configurations, fasteners, solder or adhesives. Is mentioned.

  The implant 402 further includes a screw 428 having a shaft portion 430 and a head portion 432. Shaft portion 430 includes an outer thread that mates with an inner thread on nut 422. Thus, rotation of screw 428 relative to body portion 416 causes screw 428 to translate axially relative to body portion 416. This relative motion is used to move the body portion 416 of the implant 402 from the implanted configuration to the remodeling configuration by any suitable structure, such as by using a pull wire or other forming element as described above.

  The head portion 432 of the screw 428 includes a rotational coupling such as a cavity extending axially from the proximal end of the head portion 432. Desirably, the cavity 434 is shaped to accommodate a control component of the medical device 400 such as the driver 436. In the illustrated embodiment, the cavity 434 is hexagonal and is sized to receive the hexagonal distal end portion 438 of the driver 436 (FIG. 14).

  Male connector 440 includes a head portion 432 of screw 428. Male connector 440 includes a shaft portion 442 and a head portion 444. The head portion 444 of the male connector 440 has a larger diameter than the shaft portion 442. The passage 446 extends axially through the male connector 440 and defines a first portion 448 and a second portion 450. The first portion 448 of the passage 446 is located proximate to the head portion 444 of the male connector 440 and has a diameter greater than the diameter of the second portion 450 located proximate to the shaft portion 442 of the male connector 440. The transition between the first portion 448 and the second portion 450 extends substantially transverse to the longitudinal axis of the male connector 440. The first portion 448 of the passage 446 is preferably configured to be sized and shaped to accommodate the head portion 432 of the screw 428. Desirably, the head portion 432 of the screw 428 abuts the shoulder 452 of the passage 446.

  An annular collar 454 secures the head portion 432 of the screw 428 within the passage 446. Desirably, the outer diameter of the collar 454 is substantially the same as the outer diameter of the head portion 444 of the male connector 440. The collar 454 includes an inner flange portion 456 configured in a size and shape that fits in a press-fit configuration within the first portion 448 of the passage 446 of the male connector 440.

  In a manner similar to the embodiment described above, the implant 402 desirably comprises a wire 458 operable to move the implant 402 from the first delivery configuration to the second remodeling configuration. The wire 458 is preferably attached to the distal end of the implant 402 by thermal bonding as described above or in some manner, other suitable methods determined by those skilled in the art. Desirably, the proximal end of wire 458 is attached to male connector 440 and collar 454 and is preferably thermally bonded or otherwise bonded to male connector 440 and collar 454. However, other suitable attachment methods may be used, such as adhesives or mechanical fasteners. Preferably, male connector 440 and collar 454 have a slot 460 that fits the proximal end of pull wire 458, thus allowing wire 458 to be placed flat and increasing the outer diameter of collar 454 or connector 440. I won't let you. The nut 422 includes a flat portion 464 on one side surface, and the flat portion is configured in a size and shape that allows the wire to pass through the gap.

  As described above, the delivery assembly 401 is preferably releasably coupled to the implant 402. Thus, the female connector 466 is desirably coupled to the connector wire 487 at the distal end of the shaft 406, such as by thermal bonding. The female connector 466 is preferably hollow and substantially cylindrical. The distal end of the female connector 466 includes a plurality of protrusions or finger portions 468 that engage the shaft portion 442 of the male connector 440. It is desirable that the female connector 466 can securely hold the male connector 440 due to the elasticity of the material constituting the female connector 466. Desirably, the inner surface of the finger-like portion 468 defines an annular protrusion 470 corresponding to the annular groove 472 of the male connector 440. When the female connector 466 engages the male connector 440, the annular protrusion 470 is desirably located within the annular groove 472 to facilitate relative axial movement between the delivery assembly 401 and the implant 402 and To prevent.

  Supply assembly 401 further includes a cover 474 coupled to the distal end of shaft 406. The cover 474 is axially movable from a first position where the cover of the finger-like portion 468 of the female connector 466 is removed to a second position where the cover 474 covers at least a substantial part of the finger-like portion 468. Cover 474 prevents undesired shrinkage of finger-like portion 468 in the second position and facilitates maintaining a connection between female connector 466 and male connector 440.

  To prevent rotational movement between the delivery system (including shaft 406 and female connector 466) and the body portion 416 of the implant, one of the finger-like portions 468 is removed or omitted from the female connector 466, A space or keyway 483 is formed that fits within a key 485 that is thermally bonded to the shaft portion 442 of the male connector 440.

  FIG. 14 is an enlarged view of the driver 436 away from the medical device 400. Driver 436 is preferably an elongated shaft and extends from proximal end 480 to distal end 482. The driver 436 is composed of a NiTi material, but other suitable materials may be used. The proximal end 480 of the driver 436 is desirably coupled to rotate relative to the handle assembly 404, as will be described in detail below. The distal end 482 is preferably non-circular, such as a hexagonal cross section, and is sized to engage the corresponding hexagonal cavity 434 of the screw 428. Thus, rotation of driver 436 results in corresponding rotation of screw 428. Other suitable configurations that allow rotational coupling of driver 436 and screw 428 may be used, for example, complementary polygons or other non-circular cross-sectional shapes as mating components.

  Driver 436 includes a shoulder 484 disposed on the proximal side of hexagonal distal end 482. Preferably, the shoulder 484 has a diameter greater than the width of the hexagonal distal end 482 (FIG. 15). In one preferred embodiment, shoulder 484 has a diameter of about 0.032 to 0.040 inches and a width W of about 0.027 inches. Thus, the shoulder 484 effectively functions as a stop when the hexagonal distal end 482 of the driver is inserted into the cavity 434 of the screw 428. As shown, shoulder 484 and cavity 434 desirably include complementary chamfers 486, 488 to facilitate entry of hexagonal distal end 482 into cavity 434.

  The illustrated driver 436 includes one or more reduced diameter portions 490 on the proximal side of the shoulder 484. The diameter 490 of this portion is less than both the width of the shoulder 464 and desirably the diameter of the main portion 492 of the driver 436 that extends from the proximal end of the distal portion 490 to the proximal end 480. Preferably, the main portion 492 of the driver 436 has a diameter of about 0.04 inches. Reduced diameter portion 490 has a length of about 0.5 inches or more and a diameter of about 0.027 inches. However, other suitable dimensions may be used. Desirably, the transition portions between the reduced diameter portion 490 and the main portion 492 of the driver 436 each define chamfers 494, 495, respectively, to advantageously reduce stress concentrations.

  FIG. 16 is an enlarged cross-section of a handle assembly 404 consisting primarily of a proximal handle 500 and a distal handle 502. The distal handle 502 is configured to hold the medical device 400 stationary when in use, and the proximal handle 500 is configured to be rotatable relative to the distal handle 502 so that the driver As 436 rotates, the implant 402 rotates between the delivery position and the remodeling position.

  The distal handle 502 is generally cylindrical and defines an internal cavity 504. The threaded aperture 506 extends from the cavity 504 through the distal end of the distal handle 502 and is substantially coaxial with the longitudinal axis of the handle assembly 404. Proximal connector 508 is desirably retained by a threaded connection with threaded aperture 506 and extends axially from the distal end of distal handle 502. Desirably, the distal handle 502 further includes a threaded aperture 510 located substantially transverse to the longitudinal axis and intersecting the threaded aperture 506. The set screw is advantageously threaded with the threaded aperture 506 and tightened against the proximal connector 508 to prevent unwanted axial movement of the proximal connector relative to the distal handle 502.

  Proximal connector 508 includes a central aperture 514 that passes axially through the connector. The central aperture 514 is desirably substantially concentric with the longitudinal axis of the handle assembly 404 and accommodates the catheter shaft in a fixed axial position relative to the distal handle. Shaft 406 is secured to proximal connector 508 in any suitable manner, such as, for example, adhesive or thermal bonding.

  In the illustrated embodiment, the cavity 504 opens through the proximal end of the distal handle 502 and preferably accommodates the handle connector 516 through a threaded connection therebetween. Further, the set screw configuration 517 is similar to the set screw described above with respect to the proximal connector 508 and is preferably provided to prevent undesired movement of the handle connector 516. The handle connector 516 is configured to connect the proximal handle 500 and the distal handle 502 to allow relative rotation therebetween. Handle connector 516 desirably comprises a shaft portion that extends proximally away from distal handle 502. The cylindrical passage 520 extends axially through the proximal handle and is sized to be rotatably mounted on the shaft portion 518 of the handle connector 516.

  Preferably, proximal handle 500 includes a handle release assembly 522 that allows releasable engagement with distal handle 502. The release assembly desirably includes an annular release collar 524 that surrounds the proximal handle 500. Release collar 524 is sized to be axially movable relative to proximal handle 500. A plurality of wire anchors 526 (two shown) engage the shaft portion 518 of the handle connector 516 to selectively place the proximal handle 500 in a fixed axial position relative to the distal handle 502. Fix it. Each wire anchoring device 526 is circular in cross section and includes a short leg 527 that terminates at a ball end 528 and a long leg 529 that is preferably rectangular in cross section. Desirably, the short leg 527 and the long leg 529 define an angle of about 75 ° between these legs when the wire anchoring device 526 is in the relaxed position. Preferably, each wire fixing device 526 is composed of various stainless steels, and a total of two or four or more wire fixing devices 526 are used.

  In the illustrated embodiment, the long leg 529 of the fixation device 526 is retained in the groove 530 defined by the proximal handle 500, preferably between the outer surface of the proximal handle 500 and the inner surface of the release collar 524. Is done. The plurality of apertures 532 extend radially through the proximal handle 500 and near its proximal end. The outer surface of the proximal handle 500 defines a shoulder 534 between the groove 530 and the aperture 532. Shoulder 534, when secured by release collar 524, mechanically deflects wire anchoring device 526 so that the angle between short leg 527 and long leg 529 is the same as wire anchoring device 526. Increase from the relaxed position. The inner surface of the release collar 524 defines an annular groove 536 at least when the release collar 524 is in the relaxed position, and the annular groove 536 desirably straddles the shoulder 534. A short leg 527 of the wire anchoring device 526 extends through the aperture 532. The groove 536 engages a bend 538 defined by the transition between the short leg 527 and the long leg 529 of the wire anchor 526 and an annular groove 540 defined by the shaft portion 518 of the handle connector 516. The ball end 528 is held inside.

  In FIG. 16, the release collar 524 is in the first or engaged position and the ball end 528 is retained in the annular groove 540 to prevent the proximal handle 500 from detaching from the distal handle 502. . Release collar 524 is movable toward a second position or release position in the proximal end direction of proximal handle 500 to selectively allow removal of proximal handle 500 from distal handle 502. . As the release collar 524 moves toward the release position, the edge of the groove 536 engages the wire fixing device 526 to deflect the short leg 527 and move the ball end 528 out of the groove 540 in the handle connector 516, As a result, the proximal handle 500 is released from the distal handle 502.

  Driver retainer 525 is disposed within the proximal end of passage 520 and secures driver 436 for rotation relative to proximal handle 500. Accordingly, the driver retainer 525 is preferably fixed for rotation with the proximal handle 500 by having a flat portion 531 that engages the flat portion 539 at the proximal end of the passage 520 (FIG. 17). A set screw configuration similar to that described above is used to axially secure the driver retainer 525 relative to the proximal handle 500. A pair of set screws 535, 537 secures the driver 436 axially and rotatably relative to the proximal handle 500. Thus, rotation of the proximal handle 500 results in rotation of the driver 436. Desirably, end cap 541 is press fit over the proximal end of proximal handle 500 to further secure driver retainer 525. The end cap 541 includes an aperture 540 that extends in the axial direction of the end cap 541. Desirably, aperture 540 is substantially aligned with driver 436.

  With reference to FIGS. 16 and 18, the distal handle 502 allows the delivery assembly 401 to be removed from the implant 402 after it has been properly positioned and moved from its delivery position to the remodeling position. 542. The release configuration 542 includes an annular release collar 544 that surrounds the distal handle 502. Desirably, the collar 544 is concentric with the distal handle 502 and is slidable on the distal handle 502.

  Handle pin 546 is concentrically disposed within cavity 504 of distal handle 502. A fastener such as screw 548 passes through slot 550 in distal handle 502 and connects handle pin 546 to release collar 544. Preferably, the outer threaded portion of the fastener 548 fits into and securely connects the inner threaded portion of the apertures 552, 554 of the release collar 544 and the handle pin 546, respectively. The handle pin 546 is desirably substantially cylindrical and defines an inner cavity 557 that extends from the open proximal end of the handle pin 546 to the closed distal end. The closed distal end of the handle pin 546 includes a pair of apertures 558, 560 that extend axially through the handle pin 546 and open into the cavity 557. The aperture 558 is formed and arranged in a size that allows the driver 436 to pass therethrough. Aperture 560 is sized to receive the proximal end of release wire 562. The release wire 562 extends from the handle pin 546 through any of the apertures 408, 410, 412 of the shaft 406 to the cover 474 (FIG. 13). Release wire 562 is secured to cover 474 by any suitable method, such as thermal bonding, adhesive, or mechanical fasteners. A set screw configuration 564 similar to that described above is used to secure the release wire 562 within the aperture 560 and move it axially with the handle pin 546. Thus, when the release collar 544 moves toward the proximal end of the handle assembly 404, the release wire 562 pulls the cover 474 to uncover the finger-like portion 468 of the female connector 466. When the cover 474 is in this position, the female connector 466 is disconnected from the male connector 440 so that the delivery assembly 401 can be disconnected from the implant 402 as described above.

  The handle assembly 404 also preferably includes a release collar lock arrangement 566 to substantially prevent unwanted movement of the release collar 544. This locking arrangement 566 preferably comprises a threaded aperture 568 that passes radially through the distal handle 502. Lock screw 570 provides for threaded engagement with threaded aperture 568. The lock screw 570 includes a head portion 572 that allows the release collar 544 to move toward the proximal end of the handle assembly 404 when the lock screw 570 is substantially fully screwed into the aperture 568. Disturb. Lock screw 570 is partially or completely retracted from aperture 568 to allow release collar 544 to move as desired toward the proximal end of handle assembly 404.

  The operation of the medical device 400 is substantially similar to the embodiment described above. Preferably, prior to initiating the procedure, the locking screw 570 is positioned to prevent undesired movement of the release collar 544 that can cause the delivery assembly 401 to disengage early from the implant 402. When the implant 402 is desirably placed in the coronary sinus by any suitable method, such as described above, the proximal handle 500 rotates relative to the distal handle 502, causing the driver 436 to rotate. The rotation of driver 436 causes a corresponding rotation of screw 426 so that implant 402 moves from the delivery configuration to the remodeling configuration as described above. The direction of rotation of the proximal handle 500 varies depending on the orientation of the threaded connection between the screw 28 and the nut 422. However, when using the right thread orientation, the proximal handle 500 rotates counterclockwise to move the implant 402 from the delivery configuration to the remodeling configuration.

  Once the implant 402 has achieved the desired remodeling configuration, the locking screw 570 is pulled out of the locked position, allowing the removal collar 544 to move. Next, the release collar 544 moves toward the proximal end of the handle assembly 404 and retracts the cover 474 to expose the finger-like portion 468 of the female connector 466. The handle assembly 404 is then pulled with sufficient force to deflect the finger-like portion 468 of the female connector 466 radially outward so that the female connector 466 is disengaged from the male connector 440 and the supply assembly. 401 is disengaged from the implant 402. The delivery assembly 401 is then removed from the patient, leaving the implant 402 in place.

  Although specific details have been disclosed herein for a particular proximal handpiece, various alternative handpieces are readily available to enable the practice of the present invention, as will be apparent to those skilled in the art. Can be designed and configured. Generally, the proximal handpiece is provided with a tension control device for tightening and relieving the implant and a release actuator for deploying the implant from the deployment catheter. The tension control device can take any of a variety of forms, for example, to control a motor drive on a rotatable knob or wheel, slidable lever, switch, button, knob, or rotatable driver. Other electrical control devices for, or other forms that will be apparent with respect to the disclosure herein. Similarly, the release actuator can take a variety of forms depending on the structure of the release mechanism. Generally, any of a variety of types such as an axially movable slider, switch, lever or rotatable collar, wheel or knob is used to control the release actuator. As a safety feature, any of a variety of locks is provided to prevent premature release of the implant.

  In addition, the proximal controller may include any of a variety of auxiliary ports, such as a proximal guidewire port on the wire structure, and a drug, contrast agent, or other substance, depending on the function intended for the device. And an administration port for administration.

  19 and 20 show an alternative slot pattern on the implant 600 that is similar to the pattern described above, which includes a plurality of voids 602 that affect the implant 600 moving from the delivery configuration to the remodeling configuration. Including. FIG. 19 shows a plan view of a preferred void 602 configuration in which individual voids 602 are provided. In general, the first surface of the implant is generally incompressible, which is achieved through the use of a tubular wall. The first surface of the implant is radially opposed to the second surface of the implant, and a plurality of voids 602 are provided. These voids cause the implant's second surface to expand or contract in the axial direction, resulting in curvature of the implant, as will be apparent to those skilled in the art. The number and configuration of the voids 602 affects the bending properties of the implant. In general, a gap transverse to the longitudinal axis of the implant can facilitate bending of the implant plane. For most implants intended for placement in the coronary sinus and thus having an axial length in the range of about 5 cm to about 16 cm, at least about 10 and often at least about 20 voids Is provided. Depending on the desired final curvature of the device to be implanted, and the dimensions of the voids and intervening solid wall material, 30 or more voids can be provided.

  FIG. 20 is an enlarged view of a series of adjacent voids 602. Similar to the embodiment described above, the plurality of voids 602 are arranged axially along the implant 600 and arranged to substantially traverse the longitudinal axis of the implant 600. Desirably, the void 602 extends at least about 180 ° around the circumference of the implant 600, preferably around at least about 300 ° around the circumference. In some embodiments, the void 602 extends around about 300 ° to 315 ° around the implant 600. Alternatively, the annular body of the implant comprises a spring coil in which adjacent windings are arranged slightly apart. Axial strut strength at the first surface of the implant is provided by an axially extending support, such as a flexible ribbon or core that is joined or otherwise attached to a spring coil. Prevent axial compression along the supporting surface. The opposing surface of the coil is compressed or expanded to give a curve. The coil is provided with an outer polymer sleeve.

  Desirably, both ends of each gap 602 terminate in a curvilinear gap, such as a circular gap end portion 603. Advantageously, the end portion 603 of the void 602 reduces stress concentrations at both ends of the void 602, and such stress concentrations result from bending of the implant 600 from a delivery configuration to a remodeling configuration. In some applications, the end portion 603 has a diameter of about 0.018 inches and the circumferential distance between the centers of two opposing circular portions 603 of a single air gap 602 is about 0.068 inches. This feature reduces the possibility of cracking at both ends of the void 602 in the material of the implant 600.

Each gap 602 is defined as a space between two opposing edge surfaces of the body of the implant 600. Surface 604 comprises an axially extending protrusion, eg, a substantially “U-shaped” protrusion disposed within complementary substantially “U-shaped” recess 610 of surface 606. An alternative complementary configuration such as chevron may be used. Axis A _v of both protrusions 608 and complementary recess 610 is substantially parallel to the longitudinal axis of the implant 402.

A substantially axial distance between the transverse edges 604, 606 defines the width W _{v of the} air gap 602. The air gap 602W _v may be changed according to desired performance. In general, a width in the range of about 0.010 to about 0.040 inches is often used. In the illustrated embodiment, the width _{W v} is about 0.012 inch. Desirably, at least one of the protrusions 608 and recesses 610 is less than the width _{W v} of the void, to define an interference portion 612 of the pair between the surface 604 and the surface 606.

  The interference portion 612 prevents the implant 600 from moving from the plane defined by the longitudinal axis of the implant 600 as it moves from the delivery configuration to the remodeling configuration. Advantageously, the surfaces 604, 606 contact each other within the interfering portion 612 of the void 602 in response to a force that causes the implant 600 to curve out of plane. Thus, in the illustrated configuration, the implant 600 is maintained in the desired plane as it moves from the delivery configuration to the remodeling configuration. Alternatively, the air gap 602 is configured to allow a predetermined out-of-plane movement of the implant 600 if necessary, as would be understood by one skilled in the art. For example, only one interference portion 612 can be provided to provide controlled rotational bending, or the distance between the surfaces 604, 606 can be increased or decreased within the interference portion 612.

  Any of a variety of alternative implant body structures may be used, as will be apparent to those skilled in the art in view of the disclosure herein. In general, the body is deformable from a flexible embedding orientation to a curved post-implantation orientation. The particular void pattern or other structure that promotes curvature can be varied depending on the desired manufacturing technique and clinical performance. In addition, any of a variety of alignment structures may be used to affect the shape of the implant in the post-implant orientation. While the above describes a slot pattern that promotes in-plane bending of the implant, the same structure can be used to form a compound curve or other out-of-plane bending when the implant changes orientation after implantation. It is good to rearrange along.

  Referring to FIGS. 21 and 22, an implant 100 according to another aspect of the present invention is shown. The implant 100 is positioned within or adjacent to the coronary sinus and is configured to maintain a compressive force on one face of the mitral annulus. The implant 100 includes an elongated flexible body having a proximal end 104 and a distal end 106. The body 102 can be constructed in any of a variety of ways using the structures, materials, and dimensions disclosed herein above. In general, the body 102 is flexible and can be navigated transluminally to a deployment site, such as within a coronary sinus. Alternatively, the implant is advanced through the tissue to a location outside the coronary sinus, eg, a location within the heart wall, or a location adjacent to the outer surface of the heart. Thereafter, the body 102 is manipulated such that it exerts a compressive force on at least a portion of the mitral annulus and the body 102 is locked or restrained to the second configuration.

  As shown in FIG. 22, the body 102 is configured to include a proximal segment 108, a central segment 110, and a distal segment 112. In the post-implant orientation, as shown, the proximal segment 108 and the distal segment 112 are concave in the first direction and the central segment 110 is concave in the second direction. This configuration further includes at least a first transition 114 between the proximal segment 108 and the central segment 110 and a second transition 116 between the central segment 110 and the distal segment 112.

  In the illustrated embodiment, the curvature of the proximal segment, the central segment and the distal segment are in a single plane. However, the central segment 110 lies in a plane that is rotationally offset from the plane that includes the proximal segment 108 and the distal segment 112, depending on the desired clinical performance and deployment site.

  The implant 100 preferably further comprises one or more fixation devices to hold the body 102 at a deployment site. In the illustrated embodiment, at least one, and in some embodiments, two or more proximal fixation devices 118 are supported by the proximal segment 108. Further, at least one, and in certain embodiments, at least two or more than four distal fixation devices 120 are supported by the distal segment 112. In the illustrated embodiment, first and second proximal fixation devices 118 and first and second distal fixation devices 120 are provided.

  Proximal anchoring device 118 and distal anchoring device 120 are provided on the first surface of body 102, which is the same surface as the convex surface of central segment 110 when in the post-implant orientation. In this orientation, the first surface of the implant 100 is configured to lie in contact with the inner radius wall of the coronary sinus curvature. Proximal fixation device 118 and distal fixation device 120 engage the vessel wall on the mitral valve side of the coronary sinus so that central segment 110 is advanced laterally from the first surface and the mitral annulus It makes it possible to apply a compressive force to at least one part.

  A variety of engagement structures such as a proximal fixation device 118 and a distal fixation device 120 are used to hold the implant 100 against the coronary sinus wall. Alternatively, the implant 100 is configured to “push” the opposing wall of the coronary sinus to support advancement of the central segment 110 in the mitral direction. For example, the proximal segment 108 and the distal segment 112 extend across the entire diameter of the coronary sinus and are configured to contact opposing walls. This is accomplished by remodeling the device so that the amplitude is equal to or exceeds the diameter of the coronary sinus. Alternatively, proximal and distal fixation devices 118 and 120 take the form of a tubular structure, such as a self-expanding stent, or a stent that is expanded by an inflation balloon or other expanding structure. The tubular fixation device then constrains the implant 100 to the desired orientation within the coronary sinus. As yet another alternative, the proximal and distal ends of the implant extend through the wall of the coronary sinus or are sutured or otherwise adhered to the wall of the coronary sinus. Allows remodeling as disclosed in the specification. Other alternative fixing device configurations are disclosed below.

  A variety of self-expanding or mechanically expandable structures are provided on the tubular body 102 to facilitate fixation and placement of the implant. For example, referring to FIG. 23, the proximal end 104 of the tubular body 102 is provided with a radially expandable support 140. In general, the support 140 includes a plurality of axially extending ribs or elements 142, each of which is further provided with one or more wings 144. Other structural details of suitable support structures can be found in US patent application Ser. No. 10 / 033,371 “Adjustable Left Atrial Appendice Occlusion Device” filed Oct. 19, 2001. The disclosure of this application is incorporated herein by reference.

  Referring to FIGS. 21 and 22, the implant 100 includes an elongated forming element 122 described above with respect to various configurations. Forming element 122 extends between a distal one of connecting mechanism 124 and a proximal one of connecting mechanism 126 to a threaded collar or other axially movable structure. One proximal movement of the connection mechanism 126 relative to the body 102 includes a curvature within the implant 100 as described above.

  In the illustrated configuration, the forming element 122 is attached to a threaded structure, such as a nut 128, at a location proximal to the connection mechanism. Alternatively, the thread is provided directly on the proximal portion of the forming element. The nut 128 is axially movably supported by the rotatable screw 130 using a well-known complementary threaded engagement surface. The rotation of the screw 130 will cause relative axial movement of the nut 128, as will be appreciated by those skilled in the art.

  The screw 130 is provided with one or more axial retention structures to allow rotation of the screw but to prevent axial movement. In the illustrated embodiment, the screw 130 is provided with one or more radially outwardly extending protrusions, such as a flange 132, between the first bushing 134 and the second bushing 136. To prevent axial movement. The screw 130 is maintained against axial movement and allows rotation by various other structures, such as tabs or flanges extending radially inward from the inner surface of the body 102, such tabs or flanges being , And is slidably received by one or more radially inwardly extending annular grooves in the screw 130.

  A rotational coupling 138 is provided at the proximal end of the screw 130. Coupling 138 is configured to removably receive a rotatable driver supported by the deployment catheter, and rotation of the driver within the deployment catheter causes axial movement of nut 128. In some applications, the coupling 138 includes a recess having a non-circular cross-sectional configuration, such as a hexagonal wall. This cooperates with the hexagonal distal end on the driver (disclosed herein above) to produce a removable rotational coupling.

  In the embodiment illustrated by FIG. 22, the forming element 122 extends through the interior of the body 102 at each of the proximal segment 108 and the distal segment 112 and extends outside the body 102 along the central segment 110. Extending along. See also FIG. Such a configuration in which the forming element 122 extends through the first aperture 140 at or near the proximal transition 114 and the second aperture 142 at or near the distal transition 116 is: It has been found advantageous in an implant configured to take the “w” post-embedding configuration shown in FIG. Alternatively, the forming element 122 extends along its interior along its entire length. The forming element 122 extends along the outside of the body 102 along its entire length, or extends partially inward and partially outward of the body 102 depending on the desired performance characteristics of the implant. .

  In conjunction with any of the above embodiments, the implant is axial when advanced from a first flexible configuration for transluminal delivery to a second configuration for remodeling the mitral annulus. It is desirable to change to length. This can be done in a variety of ways, for example, two or more portions of the tubular body are nested, and the first portion of the body is disposed axially displaceable within the second portion of the body. . As a result, the axial length of the body can be controllably changed when the device is deformed to a post-embedding configuration or separately from such deformation. In certain applications, it is desirable to reduce the axial length of the implant when converting the implant to a post-implant configuration. Currently, it is contemplated to shorten the implant by a distance in the range of about 10% to about 95% of the axial length of the largest implant.

  In one embodiment, controlled shortening is accomplished by providing a plurality of shortening slots or chevrons on the outer wall of the tubular body. Referring to FIG. 24, a partial view of a portion of the elongated body 320 is shown. The configuration of FIG. 24 can be applied to any of the above embodiments, as will be apparent to those skilled in the art upon consideration of the disclosure herein.

  The elongated body 320 includes a plurality of transverse gaps 330 as described above. Due to the axial compression of the elongated body 320, the gap 330 closes axially, causing the elongated body 320 to deflect away from the plane. In some of the devices disclosed above, the voids 330 are arranged on the first side of the elongated body 320, and these voids are relatively uncollapsible and thus act as a long spine of the device. It faces the second surface of the main body 320.

  According to the shortening feature of the present invention, the first plurality of shortening gaps 331 are provided on the elongated body 320. The shortened gap 331 is disposed on the elongated body 320 and allows axial compression of the body when an axial compression force used to deflect the body from a plane is applied. In the illustrated embodiment, the first plurality of shortened gaps 331 are axially aligned along the “spine” or support surface of the device opposite the gap 330.

  The second plurality of shortened gaps 333 are also provided so as to be spaced apart from the first plurality of shortened gaps 331 in the circumferential direction. In the illustrated embodiment, the first and second shortened gaps 331 and 333 are aligned along the first and second longitudinal axes and spaced about 180 ° from each other around the elongated body 320. Yes.

  In general, a shortening within the range of about 1% to about 20% of the maximum length of the device is currently envisioned. The specific number and dimensions of the shortened voids can be optimized by one skilled in the art in view of the disclosure herein and taking into account the desired clinical performance.

  Referring to FIG. 25, there is shown an alternative structure of an implant 100 according to the present invention for performing the radially inward compression disclosed above in connection with FIG. Implant 100 extends between proximal end 104 and distal end 106. The implant is believed to be divided into two or more distinct regions, such as a central segment 110, proximal and distal segments 108 and 112. At least one segment on the implant 100 comprises a compression element 140 configured to generate radial compression, such as against the posterior leaflet of the mitral valve. In the illustrated structure, the compression element 140 comprises a flexible ribbon 142. The flexible ribbon 142 is configured to project radially inward from the concave surface of the device 100 after implantation when the device 100 is deformed from the implantation configuration to the post-implantation configuration. In one embodiment, the ribbon 142 comprises a flat wire having a cross section of about 0.005 inches by about 0.020 inches and having an axial length of about 3 to about 4 cm.

  Ribbon 142 is configured to provide a radially outward compressive force using any of a variety of mechanisms. In some applications, the ribbon 142 has a fixed length and is attached to first and second locations spaced along the length of the implant 100. When the concave surface of the implant 100 is shortened in the axial direction, due to the constant axial length of the ribbon 142, the preset bend is advanced laterally outward in response to the bend of the implant. Alternatively, the compression element 140 operates in response to an active control device, such as screw rotation or axial movement of the control device.

  In addition to the central compression element 140, additional compression elements are provided. In the embodiment shown in FIG. 25, a proximal compression element 139 and a distal compression element 143 are also provided. The desirability of two or more compression elements spaced axially along the implant depends on the desired clinical performance of the device.

  In addition to the compression element 140, the implant 100 shown in FIG. 25 further supports one or more proximal tissue fixation devices 118 and distal tissue fixation devices 120. Preferably, the proximal fixation device 118 and the distal fixation device 120 are placed completely within the tubular body of the implant 100 during transluminal navigation. The proximal fixation device 118 and the distal fixation device 120 extend radially outward from the tilted orientation implant 100, and during deployment, for example, at the same time the implant 100 converts from an implantation orientation to a post-implantation orientation. Engage with. Other details of the particular fixation device configuration and deployment order are described below.

  Referring to FIG. 26, an alternative structure of the compression element 140 is shown. In this configuration, the compression element 140 comprises a basket or other structure that extends radially outward in response to axial compression movement. Basket 144 includes a plurality of axially extending ribs 146 connected to the implant at proximal hub 148 and distal hub 150. When the implant is tightened to compress the mitral annulus, the distal hub 150 and the proximal hub 148 advance in the direction of each other, resulting in the wire basket 144 being axially shortened and radially expanded. . The basket comprises two or more, preferably at least about six axial ribbons 146. In one embodiment, the basket 144 is formed by providing a plurality of axially extending slots around the metal tube. For example, any of a variety of medically compatible metals such as stainless steel, nickel titanium alloys such as Nitinol can be used. A radially expandable support structure shown in FIG. 23 is also disposed on the implant in the central segment and functions as the compression element 140.

  27 and 28, yet another variation of the present invention is shown. In this configuration, implant 100 includes a proximal portion 152 and a distal portion 154. The bending mechanism is moved to the center of the device and is shown with a rotatable screw 156. The screw rotates in response to rotation of a component 157 on the deployment device that is removably connectable to the rotatable screw. The component 157 on the deployment device is coupled to a rotatable driver disposed within the implant 100 and is further rotatably coupled to the screw 156. Thus, the rotational force on component 157 is converted to a rotatable driver 159 in the deployment device, and the rotatable screw 156 in the configuration after implanting the proximal portion 152 and the distal portion 154 as shown in FIG. Move forward. As the implant 100 is advanced in the implantation configuration direction, the one or more proximal fixation devices 118 and the one or more distal fixation devices 120 are also deployed from the device 100 as described herein. Engage with tissue.

  An alternative tensioning assembly used in the device as shown in FIG. 27 is shown in the enlarged partial view of FIG. In general, device 110 includes a rotatable screw 156. The rotatable screw 156 includes a proximal coupling 158 having a recess 160 or other releasable connector as described herein. In one convenient configuration, the recess 160 has a polygonal cross-section, such as to accommodate a six-stroke coupling on the distal end of a deployment device (not shown). A variety of complementary surface structures between the proximal coupling 158 and the deployment device are used as described above.

  Proximal coupling 158 is connected to threaded shaft 162. The threaded shaft 162 extends through an aperture 166 in the proximal block 168. Block 168 is attached to the proximal pull wire 170.

  Threaded shaft 162 is threadedly engaged within threaded aperture 172 in nut 174. Nut 174 is connected to a distal pull wire 176 that extends through the distal portion of implant 100. Proximal pull wire 170 extends proximally through the device to the location of the connection mechanism relative to the tubular body, and distal pull wire 176 extends distally relative to the tubular body to the location of the connection mechanism. .

  As can be seen in view of the above disclosure herein, rotation of the proximal coupling 158 causes the threaded shaft 162 to rotate freely with respect to the aperture 166 in the proximal block 168 and the implant. In 110, the nut 174 is advanced in the axial direction. Preferably, the aperture 166 in the proximal block 168 and the inner thread of the nut 174 are threaded to face each other, and the effect of rotation of the proximal coupling 158 in the first direction is proximal Reducing the distance between the block 168 and the nut 174. Of course, the threaded shaft 162 is suitably configured with cooperating threads as will be apparent to those skilled in the art. This has the effect of bending both the proximal portion 152 and the distal portion 154 in the curved orientation shown in FIG. In the illustrated configuration, axial advancement of proximal block 168 and nut 174 relative to each other further deploys proximal tissue fixation device 118 and distal fixation device 120. Preferably, the length of the threaded shaft 162 prevents the proximal block 168 and the nut 174 from contacting each other and further rotating the screw 156 due to the previously selected maximum number of rotations in the first direction. Configured. Thus, the maximum displacement of the proximal pull wire 170 and the distal pull wire 176 is selectively controlled so that the deflection of the proximal portion 152 and the distal portion 154 is ultimately limited to the desired shape.

The rotation of the proximal coupling 158 in the second opposing direction straightens the implant again and allows it to be repositioned, re-tensioned or removed. The rotational limit of the screw 156 in the second direction can be controlled by interference of the proximal block 168 with the proximal coupling 158.
When the block 168 screw 156 rotates in the second direction and reaches its maximum rotation, the proximal block 168 contacts the proximal coupling, thus preventing the screw from further rotating in the second direction. .

  The operation of the tissue fixation device may be performed in any of a variety of ways, as will be apparent to those skilled in the art in view of the disclosure herein. One configuration can be seen with reference to FIG. In this configuration, the distal fixation device 120 is automatically deployed in response to the proximal retraction of the distal pull wire 176.

  Referring to FIG. 29, the distal pull wire 176 is provided with at least a first tissue wing 180 and optimally a second tissue wing 182. Additional wings can be provided as needed. The tissue wings 180 and 182 are laterally inclined in the proximal direction and are inclined with openings 184 and 186, respectively, in the sidewall of the implant 100. Proximal retraction of the distal pull wire 176 causes the tissue wings 180 and 182 to advance laterally through the openings 184 and 186 at an angle inclined in the proximal direction to engage the tissue. . Tissue wings 180 and 182 are provided with a sharp distal end for penetrating tissue.

  The distal pull wire 176 extends proximally to the nut 174 as described in connection with FIG. Alternatively, the distal pull wire 176 extends across the proximal end of the implant 110 depending on the structure of the clamping mechanism.

  In the embodiment shown in FIG. 29, the distal pull wire 176 exits the tubular body at the aperture 188 and extends along the outer surface of the implant 100 on the device concave surface in a post-implant orientation. Alternatively, the distal pull wire 176 extends into the implant 100 over the entire length of the distal pull wire 176. Proximal fixation device 118 can be configured in a similar manner, as will be apparent to those skilled in the art.

  Each tissue blade 180 and 182 extends a distance in the range of about 1 mm to about 5 mm upward from the side of the implant when fully deployed. By adjusting the angle between the longitudinal axis of the wing 180 and the longitudinal axis of the implant, the length of the wing 180 is maintained while maintaining the lateral distance that the wing 180 moves within a desired range. Can be adjusted.

  In certain applications of the present invention, it is desirable to control the order in which the distal fixation device and / or the proximal fixation device is deployed for deformation of the implant from an implantation orientation to a post-implant orientation. For example, the distal fixation device 120 is desirably deployed within the wall of the coronary sinus before the implant places substantial compressive pressure on the mitral valve annulus. It is desirable that the proximal anchoring device be deployed after compression of the annulus. Alternatively, it is desirable to deploy both the proximal and distal fixation devices at the beginning of the compression cycle and apply pressure to the implant on the mitral valve annulus. Further, proximal and / or distal fixation devices can be deployed prior to the compression of the annulus. This order can be controlled in any of a variety of ways, such as providing a mismatch between the angles of the wings 180 and 182 in the implant and the apertures 184 and 186 through which the wings move. . Providing friction for the deployment of the wings tends to delay the deployment of the wings until sufficient tension is applied to the distal pull wire 176. Alternatively, by configuring the pull wire 176 and the wings 180 and 182 to have minimal deployment friction, the wings tend to deploy before sufficient compressive force is applied on the mitral annulus. is there. This order is optimized by those skilled in the art in view of the desired clinical performance.

  Although the above embodiments have been described primarily with respect to a structure having a tubular housing having various components therein, the present invention is achieved using a non-tubular structure such as a pair of adjacent axial elements. be able to. In general, the lateral bending and compression functions of the present invention are achieved as long as the first elongated flexible structure provides strut strength and the second forming element is attached near the distal end of the strut strength element. Is possible. Lateral deflection of the strut strength element occurs provided that proximal axial retraction of the forming element prevents proximal movement of the strut strength element. Similarly, when the axial distal advancement of the forming element is selected to have sufficient strut strength, the strut strength element deflects laterally in the opposite direction. The strut strength element may be in the form of a ribbon, wire, fully compressed spring, or other element that resists crushing under tension. In the above embodiment, one side wall of the tubular body provides strut strength and the forming element acts as a pull wire, so that the proximal retraction of the pull wire causes lateral deflection of the strut strength element.

  Still another implementation of the present invention can be seen with reference to FIGS. 30A and 30B. In this configuration, the distal portion 154 has one or more tissue fixation devices 120 and the proximal portion 152 has one or more proximal tissue fixation devices 118. The distal tissue fixation device 120 and / or the proximal tissue fixation device 118 can be passive (shown) or active, and the fixation device is angularly adjustable by the implant. The active tissue anchoring device can be tilted in response to the placement or tightening of the device or controlled by a control element that can be rotated or moved axially. Both the proximal tissue fixation device 118 and the distal tissue fixation device 120 need not be passive or active. For example, the distal tissue fixation device can be actively engaged with adjacent tissue, for example, by manipulation of a tissue engagement control device. The proximal tissue fixation device is passively engageable with adjacent tissue. The reverse can also be done, with the distal tissue fixation device being passively engageable with adjacent tissue and the proximal tissue fixation device being adjustably engageable using a control device on the deployment catheter. . The above description regarding active or passive tissue fixation devices applies to all embodiments herein, as will be apparent to those skilled in the art in view of the disclosure herein.

  A tensioning element 190 is provided near the junction between the distal segment 154 and the proximal segment 152. The tensioning element 190 is configured to provide tension between the proximal fixation device 118 and the distal fixation device 120.

  In some configurations, at least one proximal portion 152 and distal portion 154 include a plurality of transverse engagement structures, such as slots. See FIG. 30B. The tensioning element 190 comprises a rotatable threaded shaft (not shown) oriented such that the thread engages a transverse slot on the proximal or distal portion. Rotation of the threaded shaft using any of the various rotatable engagement configurations disclosed herein will be understood by those skilled in the art, but the axial direction of the corresponding proximal or distal portion 152, 154 Cause movement.

  In one particular embodiment, proximal portion 152 is secured to tensioning element 190. The distal portion 154 is axially movable relative to the tensioning structure by engaging one or more rotatable threads in the tensioning structure 190 in a plurality of transverse slots on the distal portion 154. Match. As the rotatable driver rotates in the first direction, it pulls the distal fixation device 120 in the proximal direction, thereby reducing the distance between the proximal fixation device 118 and the distal fixation device 120. . Alternatively, the distal portion 154 is fixed with respect to the tensioning element 190 and the proximal portion 152 is advanced or retracted axially based on the rotation of the rotatable driver. In other alternatives, each of the proximal portion 152 and the distal portion 154 engages a threaded shaft in the tensioning element 190 and is axially between the proximal fixation device 118 and the distal fixation device 120. Allows adjustment of distance.

  Each of the proximal fixation device 118 and the distal fixation device 120 is actively deployed as described hereinabove or is fixed relative to the corresponding portion 152,154. In embodiments where the fixation device is fixed relative to the corresponding support portion, the fixation device is retracted within the deployment sleeve for transluminal navigation. The deployment sleeve is advanced distally through the coronary sinus to a position distal to the connection mechanism of the distal fixation device 120. Proximal retraction of the outer sleeve relative to the implant releases the distal fixation device 120, which is tilted radially outward in the proximal direction due to its own internal bias. Proximal traction on the distal fixation device 120 causes the distal fixation device to engage tissue at the distal attachment mechanism location. The outer tubular sleeve is further retracted proximally, releasing the proximal fixation device 118. The rotation of the rotatable driver after engagement of the fixation device applies a compressive force to the mitral annulus. Any of a variety of lateral engagement structures as disclosed herein above can be used to focus pressure on a particular anatomical site, such as the posterior leaflet of the mitral valve. Configured to be used for For example, see compression element 140 and the corresponding text shown in FIG.

  For example, the compression element 140 is formed from an elongated flexible ribbon that extends along the concave surface of at least one of the distal portion 154 and the proximal portion 152. The proximal end of the compression element 140 is fixed relative to the proximal portion 152 and the distal end of the compression element 140 is fixed relative to the distal portion 154. As the tensioning element 190 is manipulated to reduce the axial length of the implant, the compression element 140 extends radially inward from the concave surface of the device.

  In the following embodiments, deployment of the compression element corresponds to shortening or tensioning of the device. In an alternative implementation of the present invention, the lateral advancement of the compression element 140 is individually controlled by tensioning the tensioning element 190. In this embodiment, the tensioning element 190 is adjusted to seat the proximal anchoring device 118 and the distal anchoring device 120 to impart some tension to the mitral annulus. In the following tensioning step, the compression element 140 is deployed laterally. Lateral deployment can be accomplished by rotating a rotatable driver or axially moving an axial driver within the deployment catheter, by an inflation lumen within the deployment catheter, or for those skilled in the art as disclosed herein. This is accomplished by inflating the laterally inflatable balloon by any of a variety of structures that are apparent when consideration is given.

  31A-C show partial cross-sectional side elevational views of an alternative structure of the implant 900, similar to the view shown in FIG. 30A. Implant 900 includes a proximal portion 152, a distal portion 154, and a tensioning element 190. The tensioning element 190 is used to couple the proximal portion 152 to the distal portion 154 and to tension and release between them.

  As shown in FIG. 31A, the proximal portion 152 includes a proximal tissue fixation device 118 and a proximal ribbon 902. Proximal tissue fixation device 118 is laser cut from a stainless steel tube and has an arcuate cross-sectional shape (not shown). Alternatively, any of a variety of tissue fixation device structures and materials can be used, as described in detail above and well known to those skilled in the art. In one embodiment, the proximal tissue fixation device 118 includes an entry point 904 and two wings to securely hold the proximal tissue fixation device 118 in place after deployment. Various entry points 904 and wings 906 are used to achieve the desired bed leaving result, and the particular proximal tissue anchoring device 118 structure will vary depending on the particular clinical requirements.

  Proximal tissue fixation device 118 preferably includes two holes 908 that partially rotatably couple proximal tissue fixation device 118 to pivot 910 that couples to proximal ribbon 902. Used for. One embodiment of such a pivot 910 is shown in detail in FIG. 31C. The pivot 910 can be integral with the material of the ribbon 902 or can comprise a pin or other device that couples to the proximal ribbon 902. Proximal portion 152 is used to bias proximal tissue fixation device 118 and its entry point 904 rotates away from proximal ribbon 902 in the tissue direction upon deployment. In one embodiment, the spring 912 is cut from the same tubing used to form the proximal tissue fixation device 118 and is integral with the proximal tissue fixation device 118. In another embodiment, the spring 912 has a twisted structure that is well known to those skilled in the art.

  The total length of the proximal tissue fixation device 118 is preferably about 6 mm, although the actual length is selected according to the specific requirements of the clinical environment. In one embodiment, the length of the proximal tissue fixation device 118 is selected so as not to penetrate through the entire coronary sinus wall during deployment. Generally, the length of the proximal tissue fixation device 118 is about 1 mm to about 15 mm.

  The distal portion 154 preferably comprises a distal tissue fixation device 120, a distal ribbon 914, and a spring 912 as shown in FIG. 31A. Distal tissue fixation device 120 is similar to proximal tissue fixation device 118 and has features and dimensions similar to those described in detail above. The distal ribbon 914 preferably includes a plurality of slots 916 that couple with the tensioning element 190 as described in detail below. The pitch of the slots 916, ie the spacing between the centers of the slots 916, partially defines the resolution of the tension adjustment function applied between the proximal and distal tissue fixation devices 118, 120. In one embodiment, the slot pitch is about 1 mm. According to another method, the slot pitch is between 0.1 mm and 3 mm. In another embodiment, the slot pitch is not constant along the length of the distal ribbon 914. The distal ribbon 914 has a relatively large pitch or proximal end slot width of the distal ribbon 914 and a relatively small pitch or distal end slot width of the distal ribbon 914. Designed to. Alternatively, the distal ribbon 914 has no slots and a continuous rather than stepwise movement of the distal ribbon 914 is used to tension between the proximal and distal tissue fixation devices 118, 120. give. The proximal and distal tissue fixation devices 118, 120 are described in detail below. The distal ribbon 914 preferably comprises a pull wire disconnect 918 for releasably coupling to the tab pull wire 944, as described in detail below with respect to FIGS.

  As shown in FIGS. 31A and 31B, the implant 900 also includes a tensioning element 190. In one embodiment, the tensioning element 190 includes a housing 920, a latch 922, a spacer 924, and an insert 926. In one embodiment, the housing 920 is manufactured from stainless steel tubing, but other shapes and materials of the housing 920 may be used. In one embodiment, the housing 920 is made from nickel titanium tubing. Proximal ribbon 902 preferably uses any of a variety of methods such as bonding, gluing, or the housing 920 using any of a variety of fasteners well known to those skilled in the art. It is attached to the lumen. In one embodiment, the proximal ribbon 902 is attached to the housing 920 and the axial position of the proximal tissue fixation device 118 is fixed relative to the housing 920.

  The housing 920 also includes a latch 922 with the distal end of the latch 922 attached to the spacer 924. The latch 922 includes a tongue 928 that bends toward the distal ribbon 914 at an angle relative to the distal ribbon 914. The tongue 928 is designed to move through the opening 930 in the spacer 924 and engage the slot 916 in the distal ribbon 914. By engaging a slot 916 in the distal ribbon 914, the latch 922 prevents the distal ribbon 914 and the distal tissue fixation device 120 from moving axially in the distal direction. The opening 930 in the spacer 924 bends sufficiently to allow the tongue 928 of the latch 922 to disengage from the slot 916 in the distal ribbon 914 when the distal ribbon 914 moves in the proximal direction. Have sufficient dimensions to be possible. The ratchet mechanism allows stepwise movement of the distal ribbon 914 (described in detail below) as the distal ribbon 914 moves in the proximal direction, and further the distal ribbon 914 is distal. To move in the direction of. The amount of movement for each ratchet step is related to the pitch between the slots 916 in the distal ribbon 914 as described above.

  In another embodiment, as described above, the distal ribbon 914 does not include a slot. In such an embodiment, the friction between the tongue 928 of the latch 922 and the distal ribbon 914 causes the distal ribbon 914 to move continuously in a proximal direction, eg, non-stepwise or infinitely adjustable. That is sufficient to prevent the distal ribbon 914 from moving in the distal direction. In another embodiment, shallow recesses, ribs or other textures, or partially deep slots are added to the surface of the distal ribbon 914 to provide enhanced friction to the tongue 928. In one embodiment, movement of the distal ribbon 914 in the proximal direction is accomplished by releasing or releasing the tongue 928 of the latch 922 from the distal ribbon 914.

  In one embodiment, the housing 920 also includes a latch release ribbon 932, preferably disposed between the spacer 924 and the distal ribbon 914, as shown in FIG. 31A. Latch release ribbon 932 is also axially movable relative to housing 920 and distal ribbon 914. In one embodiment, as the latch release ribbon 932 moves proximally, the tongue 928 of the latch 922 is raised and the latch 922 is disengaged from the slot 916 in the distal ribbon 914. As the distal ribbon 914 disengages from the latch 922, it moves in the distal direction, thereby increasing the distance between the proximal and distal fixation devices 118, 120.

  In one embodiment, the lumen portion of the housing 920 is filled with an insert 926, as shown in FIG. 31B. As shown, the insert 926 fills the space between the spacer 924 of the tensioning element 190 and the housing 920. In one embodiment, the portion of the lumen between the distal ribbon 914 and the housing 920 does not include the insert 926, but in other embodiments. In one embodiment, the insert 926 between the distal ribbon 914 and the housing 920 is omitted, and the friction on the distal ribbon 914 when moving the distal ribbon 914 relative to the housing 920 is eliminated. It is advantageous to reduce it.

  FIG. 31C shows one embodiment of the distal ribbon 914 described in detail above. The distal ribbon 914 shown is about 9 cm in length, but the length of the distal ribbon 914 can be selected depending on the clinical requirements of the particular treatment. In general, the length of the distal ribbon 914 ranges from about 2 cm to about 20 cm. The length of the proximal ribbon 902 has similar dimensions, and the overall length of the implant 900 ranges from about 2 cm to about 20 cm, preferably from about 5 cm to about 15 cm, more preferably from about 7 cm to about 10 cm. is there. In one embodiment, the overall length of the implant 900 is about 9 cm.

  In the illustrated structure, the cross profile of the implant 900 is determined by the diameter of the housing 920 as shown in FIG. 31B. In one embodiment, the diameter of the housing 920 is such that the implant 900 is fed inside a catheter having a diameter lumen ranging from 6 French (about 0.079 inches) to 20 French (about 0.262 inches). Choose to In one embodiment, the length of the housing 920 ranges from about 3 mm to about 10 mm, preferably from about 5 mm to about 8 mm, more preferably from about 6 mm to about 7 mm, as shown in FIG. 31A.

  Referring to FIG. 31D, an uncoupled subassembly 936 is shown according to one embodiment of the present invention. Uncoupled subassembly 936 represents the mechanism by which implant 900 disengages from the delivery catheter and handpiece, as described in detail below. Uncoupled subassembly 936 includes distal ribbon 914, cover 938, cover pull wire 940, tab 942, and tab pull wire 944. The pull wire disconnect 918 of the distal ribbon 914 engages a flange 946 that protrudes from the tab 942, as shown in detail in FIG. 31E. Tab pull wire 944 is coupled to tab 942 so that proximal movement of tab pull wire 944 relative to catheter 948 (shown in FIG. 31F and described in detail below) is distal ribbon 914 relative to proximal tissue fixation device 118. And translate to the proximal movement of the distal tissue fixation device 120.

  Cover 938 is made of stainless steel tubing and slides over tab pull wire 944 and distal ribbon 914. The cover 938 keeps the flange 946 of the tab 942 engaged with the pull wire disconnect 918 of the distal ribbon 914 as the tab pull wire 944 moves in the proximal direction. Cover 938 is coupled to cover pull wire 940 and when cover pull wire 940 is moved in the proximal direction, cover 938 is moved in the proximal direction and tab 942 is pulled from pull wire disconnect 918 on distal ribbon 914. release. In one embodiment, cover pull wire 940 is a stainless steel hypotube or wire that is smaller in diameter than the lumen of cover pull wire 940. In one embodiment, the cover pull wire 940 and the tab pull wire 944 are substantially aligned, and the tab pull wire 944 moves from the uncoupled subassembly 936 to the handpiece 958 within the cover pull wire 940 (shown in FIG. 32A).

  The catheter 948 is removably coupled to the housing 920 of the implant 900 by a catheter coupling 950 as shown in FIG. 31F. In one embodiment, the catheter coupling 950 includes a single slot 952 and two fingers 954 extending into the slot 952. Fingers 954 are attached to catheter 948 and the axial and rotational motion of catheter 948 is converted to the axial and rotational motion of housing 920 and implant 900. The slot 952 is located on the housing 920 and, in one embodiment, is shaped to form a bayonet-type coupling between the housing 920 and the catheter 948, as is well known to those skilled in the art. . In other embodiments, two or more or less than two fingers 954 are used to removably couple the housing 920 to the catheter 948. In one embodiment, circular rings, tabs, hooks, or other devices well known to those skilled in the art are used in place of fingers 954.

  In one embodiment, finger 954 is coupled to release wire 956 and proximal movement of release wire 956 causes finger 954 to bend inward and disengage from slot 952 in housing 920. Upon disengagement, the catheter 948 rotates and moves proximally relative to the housing 920, separating the catheter 948 from the implant 900. In one embodiment, release wire 956 is also coupled to latch release ribbon 932 (shown in FIG. 31A). In one embodiment, proximal movement of the release wire 956 over the release distance causes the latch release ribbon 932 to release the latch 922 from the distal ribbon 914. Further, due to the proximal movement of the release wire 956 over the release distance, as described above, the finger 954 does not bend sufficiently and does not detach from the slot 952 of the housing 920.

  In one embodiment, release wire 956 comprises a hypotube having a lumen of sufficient diameter to accommodate cover pull wire 940 and tab pull wire 944. In one embodiment, release wire 956, cover pull wire 940 and tab pull wire 944 are all aligned substantially coaxially as they move proximally from catheter coupling 950 and uncoupled subassembly 936 to the handpiece. The cover pull wire 940 is at least partially disposed within the release wire 956 and the tab pull wire 944 is disposed at least partially within the cover pull wire 940.

  Referring now to FIG. 32A, a handpiece 958 is shown. According to another aspect of the invention, the handpiece 958 includes a strain relief device 960, a body 962, a distal actuator 964, an interlock device 966, and a proximal actuator 968. Release wire 956, cover pull wire 940, and tab pull wire 944 pass through the lumen of strain relief 960 and enter handpiece 958. Release wire 956 is coupled to distal slider 970, cover pull wire 940 is coupled to central slider 972, and tab pull wire 944 is coupled to proximal slider 974. The body 962 is formed, for example, from two or more parts machined from metal or plastic and joined together. Alternatively, the body 962 is molded from a single material such as, for example, plastic molded by injection molding.

  In one embodiment, the distal actuator 964 is threadably engaged with the body 962 and rotation of the distal actuator 964 results in axial movement of the distal actuator 964 relative to the body 962. The distal actuator 964 is coupled to the distal slider 970 by at least one pin 976 (shown in FIG. 32B) that moves freely within an axial slot 978 in the body 962. Distal slider 970 is coupled to release wire 956 by bonding, bonding, bonding, crimping, or other methods well known to those skilled in the art. Catheter 948 extends from handpiece 958 to implant 900 and is coupled to implant 900 as described above, thereby fixing the axial position of handpiece 958 relative to implant 900. As a result of multiple couplings as described above, rotation of distal actuator 964 is translated into axial movement of release wire 956 relative to handpiece 958, catheter 948, and implant 900. Accordingly, proximal movement of the distal actuator 964 over the release distance causes the latch release ribbon 932 to move sufficiently proximal and the latch 922 to move away from the distal ribbon 914, as described in detail above. Come off. Further, as distal actuator 964 moves further proximally, finger 954 of catheter coupling 950 disengages from slot 952 of housing 920 as described in detail above and below.

  In one embodiment, proximal actuator 968 is coupled to threaded rod 980 so that rotation of proximal actuator 968 causes threaded rod 980 to rotate in the same direction. The threaded portion of threaded rod 980 is a threaded portion located on the lumen of central slider 972 and engages the threaded portion through which threaded rod 980 extends. The lumen of the proximal slider 974 through which the threaded rod 980 extends does not include a thread. The interlock device 966 includes two pins 976 that engage both the central slider 972 and the proximal slider 974 and move freely in the axial direction within the second axial slot 982 of the body 962. The interlocking device 966 keeps the central slider 972 and the proximal slider 974 fixed relative to each other. Thus, as the central slider 972 moves proximally relative to the body 962 from rotation of the proximal actuator 968, the proximal slider 974 also moves proximally relative to the body 962.

  The interlock device 966 is removed from the handpiece 958 and the central slider 972 and the proximal slider 974 are no longer coupled axially. By removing the interlock 966, the central slider 972 moves proximally relative to the proximal slider 974. Such an adjustment feature is advantageous when manipulating the implant 900 and catheter 948 and when the implant 900 is removed from the catheter 948 as described in detail below.

  In one embodiment, the central slider 972 is coupled to the cover pull wire 940 such that proximal movement of the central slider 972 relative to the body 962 results in proximal movement of the cover pull wire 940 relative to the catheter 948. In one embodiment, proximal slider 974 is coupled to tab pull wire 944 and proximal movement of proximal slider 974 relative to body 962 results in proximal movement of tab pull wire 944 relative to catheter 948.

  In one embodiment, the implant 900 is delivered and deployed transluminally inside the coronary sinus of a medical patient by the following procedure. An outer sheath (not shown) is delivered transluminally to the distal region of the coronary sinus by using methods well known to those skilled in the art. The exact location within the coronary sinus is determined by the physician depending on the clinical requirements of the particular case. The outer sheath includes a lumen of sufficient diameter to accommodate the implant 900. Implant 900 is coupled to catheter 948, which is coupled to handpiece 958 as described in detail above.

  Implant 900 is advanced distally to the distal tip of the outer tube by moving handpiece 958 in the distal direction. The position of the implant 900 relative to the outer tube and the coronary sinus is determined using a fluoroscope, as is well known to those skilled in the art. When the implant 900 is correctly placed in the outer tube, the coronary sinus, the outer tube moves proximally to expose the distal tissue fixation device 120. As described above, the distal tissue fixation device 120 rotates by being biased by the force of the spring 912 of the distal tissue fixation device 120 and engages the medical wall of the coronary sinus. Next, the handpiece 958 moves proximally and presses the entry point 904 of the distal tissue fixation device 120 into the heart tissue of the coronary sinus.

  When the distal tissue fixation device 120 is properly engaged within the coronary sinus, the outer sheath moves proximally to expose the proximal tissue fixation device 118. The shape of the proximal ribbon 902 allows the proximal tissue fixation device 118 to engage tissue.

  The implant 900 reduces the distance between the proximal tissue anchoring device 118 and the distal tissue anchoring device 120, deforms the shape of the mitral annulus, and provides clinical performance as described in detail herein. Adjusted to improve. Handpiece 958 is retained and rotates proximal actuator 968. When the proximal actuator 968 is rotated, the tab pull wire 944 and cover pull wire 940 move proximally as described above. Proximal movement of tab pull wire 944 and cover pull wire 940 is converted to proximal movement of distal ribbon 914 as described above. The housing 920 of the tensioning element 190 is coupled to the catheter 948 at the catheter coupling 950, which is coupled to the handpiece 958. Thus, the proximal movement of the cover pull wire 940 and the tab pull wire 944 relative to the handpiece 958 causes the distal ribbon 914 and the distal tissue fixation device 120 to be proximal to the housing 920 and the proximal tissue fixation device 118. Moving.

  In one embodiment, the physician confirms the position of the implant 900 and the mitral annulus using visualization techniques well known to those skilled in the art, such as fluoroscopy. If the physician determines that it is necessary to move the distal tissue fixation device 120 distally, in one embodiment, the following procedure is performed. Distal actuator 964 rotates relative to handpiece 958 until distal actuator 964 moves proximally by a distance equal to the release distance, as described in detail above. By doing so, the release wire 956 moves proximally by a distance equal to the release distance, so that the opening 930 in the latch release ribbon 932 also moves proximally by a distance equal to the release distance. Such movement causes the tongue 928 of the latch 922 to rise from the slot 916 of the distal ribbon 914 so that the distal ribbon 914 can then rotate the proximal actuator 968 in the opposite direction of the above rotation. Move distally.

  Once the implant 900 is properly positioned and the distance between the proximal tissue anchoring device 118 and the distal tissue anchoring device 120 has been adjusted to the appropriate dimensions, the physician can remove the catheter from the medical patient to remove the medical Decide treatment. By doing so, in one embodiment, the catheter 948 is removed from the housing 920 of the implant 900 and the cover pull wire 940 and tab pull wire 944 are disengaged from the distal ribbon 914.

  To disengage the cover pull wire 940 and the tab pull wire 944 from the distal ribbon 914, the interlock device 966 is removed from the hand piece 958 and the proximal actuator 968 is rotated relative to the hand piece 958. As the proximal actuator 968 rotates relative to the removed interlock 966, the center slider 972 moves proximally relative to the proximal slider 974 so that the cover pull wire 940 is relative to the tab pull wire 944. Move proximally. Proximal movement of the cover pull wire 940 moves the cover 938 proximal to the tab 942 so that the tab 942 is disengaged from the pull wire disconnect 918 of the distal ribbon 914. The tab 942 is detached from the pull wire disconnect 918 by detaching from the pull wire disconnect 918 by its own biasing force, or by rotating the handpiece 958 as described below.

  To disengage the catheter 948 from the housing 920 of the implant 900, the distal actuator 964 is moved proximally relative to the handpiece 958 over a distance sufficiently greater than the release distance. 964 is rotated. In one embodiment, the distal actuator 964 rotates and is limited by interference between the pin 976 of the axial slot 978 and the proximal edge of the axial slot 978. This movement causes the finger 954 attached to the distal end of the catheter 948 to bend inward a portion of the distance to erase the slot 952 in the housing 920, and as described above, the latch release ribbon 932 is fully Pulled out. The handpiece 958 is then rotated and moved proximally so that the finger 954 of the catheter 948 rotates and moves out of the slot 952 of the housing 920. In one embodiment, rotation and proximal movement of the handpiece 958 also causes the flange 946 of the tab 942 to disengage from the pull wire disconnect 918 of the distal ribbon 914. The catheter 948 is then removed from the patient's body by pulling proximally from the outer tube.

  Referring to FIG. 33, a side elevation view of an implant according to the present invention is shown. The implant includes a distal fixation device 120, shown in more detail in FIG. Distal fixation device 120 includes a sharp proximal end 702 for penetrating tissue. The distal end 704 is pivotally attached to the wall of the implant, for example, by one or more pins 706 that are rotatably received within the aperture of the tubular wall. The distal fixation device extends parallel to the longitudinal axis of the implant to form a low cross profile, and the tissue fixation device is radially from the longitudinal axis of the implant as shown in FIG. It is tilted outward and is movable between a second position that engages the tissue. Other details of the distal anchor mechanism are shown in FIG.

  The proximal end of the implant 710 is shown in FIG. The implant includes a proximal tissue anchoring device 712 that slopes radially outward away from the implant and engages the wall of the coronary sinus on the mitral valve side of the device. Any of a variety of deployment mechanisms can be used for the proximal tissue fixation device 712.

  One or more proximal and distal fixation devices are provided with lateral alignment or biasing elements to advance the device laterally within the blood vessel, the mitral valve side of the device being the coronary sinus Placed against the wall. This allows the proximal and distal fixation devices to be deployed to fully engage adjacent tissue. The lateral alignment structure shown in FIG. 35 is in the form of a flexible wire, strip or loop 714 that is present in the coronary sinus when released from the deployment catheter and / or advanced from the implant, A lateral spring biasing force is applied to the. In the illustrated embodiment, the loop 714 is in the form of a biasing wire such as Nitinol. Any of a variety of structures are used to maintain the implant off-center within the vessel and optimize the engagement of the tissue fixation device to the vessel wall. For example, an inflatable side balloon on the distal end of the deployment catheter or on the implant is inflated in a tissue engagement step. Any of a variety of inflatable wire cages may be implemented off-center at the distal end of the implant or deployment catheter to move the implant laterally from the center within the vessel.

  Referring to FIG. 36, a schematic side elevational view of the implant shown in FIGS. 33-35 is shown. As can be seen in these figures, the distal fixation device 120 is actuated by the axial proximal proximal tension of the pull wire 720. Pull wire 720 is pivotally attached to distal fixation device 120 at a position that is laterally offset from the axis of rotation. The axis of rotation is concentric with one or more pins 706 that pivotally hold the distal fixation device 120 in place at the distal end 722 of the implant. In the illustrated embodiment, proximal axial advancement of the pull wire 720 causes the distal fixation device 120 to tilt radially outward relative to the longitudinal axis of the implant.

  A spinal support 722 is shown in the central segment of the implant. The spinal support 722 includes any of a variety of elements, such as a flexible ribbon of stainless steel, nitinol or other material, to enhance the strut strength of the implant in this region.

  The proximal end 710 of the implant is shown in detail in FIG. In the figure, a schematic representation of a fixing device hoop 714 is shown. The fixation device hoop 714 comprises any of a variety of structures, such as a loop or other elastic element shown in FIG. 35, which is biased radially outward from the longitudinal axis of the implant and on the opposite side of the vessel wall. In contact, the proximal anchor hook 712 is biased toward the mitral valve in the vessel wall.

  In all embodiments disclosed herein where a tubular body is provided, the space within the tubular body is used to support any of a variety of drug delivery means. For example, a microporous bead, filament or other structure is supported within the tubular body. Any of a variety of soluble or absorbable gels can be used to support one or more active agents and deliver them from the implant into the blood vessel or vessel wall. The active agent is supported using any of a variety of known drug delivery techniques, for example, by erosion of the support, migration of the active agent through the microporous structure, or other methods known in the drug delivery arts. Released from the body.

  The active agent support supported within the implant is provided with any of a variety of active agents. These active agents include anticoagulants, anti-inflammatory agents, other responses to smooth muscle cell proliferation or injury, antibiotics, enhancers of endothelial growth, or others known in the prior art.

  According to another aspect of the present invention, an electronically possible implant is provided. Such implants and related methods disclosed hereinabove can be modified to include the automated features described below, as will be apparent to those skilled in the art in view of the disclosure herein.

  Although the implant is primarily described herein in connection with a device that applies pressure to the posterior leaflet of the mitral valve, the implant according to the present invention can be used for all other diverse medical indications. . For example, such an implant can be modified for use when applying compressive force to other valves in the heart. A modified embodiment of the resisted device is placed adjacent to or around the left ventricle of the heart, such as to assist a CHF patient. This device is placed near any of a variety of natural sphincters, such as the lower esophageal sphincter, to treat gastroesophageal reflux disease. Implants are placed near the pylorus or somewhere in the stomach and are used to treat obesity. Modified versions of the implants disclosed herein are placed near the nerve to selectively exert pressure on nerves that affect the transmission of pain or other symptoms.

  Generally, the implant is configured to communicate wirelessly with external components. Alternatively, the one or more conductors are provided to allow direct electrical communication with the implant. The electrical conductor is advanced through the artificial tissue tube or in the access lumen in the case of transluminal implantation. The proximal end of the electrical conductor is placed under the patient's skin, for example for later touch. Alternatively, the implant has a remote receive coil or antenna generally implanted subcutaneously and connected to the implant by at least one conductor.

Telecommunications between external and internal components allows transmission of control signals to affect the internal components. Further, diagnostic or status information is read from or transmitted to the internal unit using external components. Spatial relationship information regarding the position of the implant is also communicated to the external component. The force on the implant or implant component or the relative position of the implant component is transmitted. The internal components are primarily described herein with respect to mechanical compression devices for applying pressure to extravascular tissue structures, but may further include any of a variety of on-board diagnostic sensors, such as Physiological parameters such as blood flow, blood pressure, pH, pO ₂ , pCO ₂ , the blood sample can be determined.

  Although the invention has been described with reference to certain preferred embodiments, those skilled in the art will be able to incorporate the invention into other embodiments or implement through other steps in view of the disclosure herein. . Furthermore, features from any of the embodiments disclosed herein can be incorporated into other embodiments, as will be apparent to those skilled in the art. Accordingly, the scope of the invention is not intended to be limited by the specific embodiments disclosed herein, but is intended to be defined by the following claims.

FIG. 1 is a schematic illustration of the heart, showing one embodiment of the mitral annuloplasty device of the present invention deployed in the coronary venous system. 2A and 2B are schematic illustrations of the mitral annuloplasty device shown in FIG. 1 in second and first configurations. FIG. 3 is a side elevation view of an implant and deployment catheter according to the present invention. FIG. 4 is a segmented view of the assembly shown in FIG. 3, showing an enlarged partial view of the implant attachment region of the assembly. FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. FIG. 6 is a perspective view of the proximal region of an implant according to the present invention. FIG. 7 shows a partial cross-sectional view of a region of the device assembly that is similar to the region shown in FIG. FIG. 8A shows a partial cross-sectional side view of the implant in the first configuration during the first use mode. FIG. 8B is a view similar to the implant shown in FIG. 8A, where the implant is in the second configuration during the second use mode. 9A-B are side elevation views of the distal end portion of the supply assembly coupled to the elongated body, each showing the elongated body during two modes of operation. 9A-B are side elevation views of the distal end portion of the supply assembly coupled to the elongated body, each showing the elongated body during two modes of operation. FIG. 9C shows a side view of a portion of the implant shown in FIG. 9A. FIG. 9D shows a cross-sectional view taken along line 9D-9D of FIG. 9C, showing a pattern of connected transverse slots. FIG. 9E shows a cross-sectional view through line 9E-9E of FIG. 9D. FIG. 9F is a partial cross-sectional view showing the connection between the forming or deflecting element and the elongated body. FIG. 9G shows a partial schematic view of two connecting segments according to one particular mode of the elongated body shown in FIGS. FIG. 10 is a bottom view of an alternative medical device that includes a delivery assembly comprising a handle assembly and a shaft and an implant configured to remodel the mitral valve. 11 is a cross-sectional view of the shaft of the medical device of FIG. 10 taken along line of sight 11-11 of FIG. 12 is an enlarged view of a portion of the medical device of FIG. 10 comprising an implant and a connection assembly for releasably connecting the implant assembly. FIG. 13 is an enlarged view of the connection assembly of the medical device of FIG. 13A is a cross-sectional view of the male connector of FIG. 13B is a cross-sectional view taken along line of sight 13B-13B of FIG. 13C is a partial cross-sectional view taken along line of sight 13C-13C in FIG. 13D is a cross-sectional view taken along line of sight 13D-13D in FIG. 14 is a plan view of the rotation driver of the supply assembly of the medical device of FIG. 10 viewed away from the medical device. 15 is an end elevation view of the hexagonal distal end of the driver of FIG. 14 taken along line 15-15 of FIG. 16 is a cross-sectional view of the handle assembly of the medical device of FIG. 17 is a cross-sectional view taken along line of sight 17-17 in FIG. 18 is a plan view of a portion of the handle assembly of FIG. 16 taken along line 18-18 of FIG. 19 is a plan view of a slot pattern of an implant, such as the implant of FIG. FIG. 20 is an enlarged view of the slot configuration of FIG. FIG. 21 is a cross-sectional view of another implant according to the present invention. 22 is a side elevation view of the device of FIG. 21 in the direction of operation. FIG. 23 is a side elevation view of an implant similar to the implant shown in FIG. 22 in an implanted configuration with an expandable basket thereon for securing within a blood vessel. FIG. 24 is a side elevational view of the implant showing a plurality of axially shortening voids. FIG. 25 is a side elevational view of an implant according to the present invention having a plurality of compression elements and / or fixation members thereon. FIG. 26 is a side elevational view of an implant according to the invention having an alternative compression element thereon. FIG. 27 is a side elevation view of an implant according to another method of the present invention. FIG. 28 is an enlarged partial cross-sectional view of a portion of the implant shown in FIG. FIG. 29 is a partial cross-sectional view of a distal anchor assembly according to the present invention. Figures 30A and B are schematic illustrations of an alternative implant of the present invention. FIG. 31A is a side elevation view of an alternative implant of the present invention. 31B is a cross-sectional view taken along line 31B-31B of FIG. 31A. FIG. 31C is a plan view of a ratchet strip for use in the implant of FIGS. 31A and 31B. FIG. 31D is a plan view of an uncoupled subassembly for use with the ratchet strip of FIGS. 31E is a cross-sectional view taken along line 31E-31E of FIG. 31D. FIG. 31F is a plan view showing catheter coupling of the implant of FIGS. FIG. 32A is a cross-sectional view of a proximal deployment handpiece. 32B is a partial cross-sectional view of the proximal deployment handpiece of FIG. 32A rotated 90 °. FIG. 33 is a side elevation view of an alternative implant of the present invention. FIG. 34 is a side elevational view of the distal end of the implant of FIG. FIG. 35 is a side elevational close-up view of the proximal end of the implant of FIG. FIG. 36 is a partial cutaway view of a side elevation of an implant according to another method of the present invention. FIG. 37 is a close-up view of the proximal end of the implant of FIG.

Claims (25)

A medical device for remodeling a mitral annulus adjacent to a coronary sinus,
An elongated body having a proximal end and a distal end, wherein the mitral annulus is removed from a first flexible configuration for transluminally supplying at least a portion of the coronary sinus. A long body movable to a second configuration for modeling;
A forming element attached to the elongated body for manipulating the elongated body from the first supply configuration to the second remodeling configuration;
The medical device, wherein the elongated body in the second remodeling configuration includes a first curve that is concave in at least a first direction and a second curve that is concave in a second direction. The medical device according to claim 1, wherein the main body in the second configuration includes a concave third curve in the second direction. The medical device according to claim 1 or 2, wherein the elongate body comprises a tube having a plurality of transverse slots therein. The medical device according to any one of claims 1 to 3, further comprising a lock for holding the main body in the second configuration. The medical device according to any of the preceding claims, wherein the device is movable from the delivery configuration to the remodeling configuration in response to a proximal retraction of at least a portion of the forming element. 6. The medical device of any one of claims 1-5, wherein the device is movable from an implanted configuration to the remodeling configuration in response to distal advancement of at least a portion of the forming element. The medical device according to any one of the preceding claims, wherein at least a first part of the forming element extends into the body and a second part of the forming element extends along the outside of the body. apparatus. The medical device according to any one of claims 1 to 7, further comprising at least one fixation device for engaging with a site in the blood vessel. 9. The medical device of claim 8, wherein the fixation device comprises at least one wing for piercing the vessel wall. 9. The medical device of claim 8, comprising a first tissue fixation device at the proximal end and a second tissue fixation device at the distal end. The medical device according to any one of the preceding claims, wherein the device has an axial length of about 10 cm or less. The medical device of claim 11, wherein a maximum cross-sectional dimension through the device is about 10 mm or less. An implant for placement in a patient's body,
An elongated flexible body having a proximal portion, a central portion and a distal portion;
A forming element extending through at least a proximal portion and a distal portion of the body;
A removable coupling on the body for removably attaching the body to a deployment catheter;
An implant wherein manipulation of the forming element deflects the central portion laterally relative to at least one portion of the proximal portion and the distal portion. The implant of claim 13, wherein the body comprises a tubular wall. The implant of claim 14, wherein the tubular wall is substantially incompressible along a first surface of the central portion. The implant of claim 15, comprising a plurality of voids in a wall along the second surface of the central portion so that the second surface can be shortened or expanded axially. The implant of claim 16, wherein at least some of the voids include slots extending substantially transversely through the wall. The implant of claim 17, comprising at least 10 transverse slots in the wall of the second surface. The implant of claim 18, comprising at least 20 transverse slots in the wall of the second surface. 14. Implant according to claim 13, wherein the forming element comprises an axially movable element. 21. An implant according to claim 20, wherein the forming element comprises a pull wire. Manipulation of the forming element introduces a first curve into the central portion of the body that is concave in a first direction, and at least one of the proximal and distal portions of the body that is concave in the second direction. 14. Implant according to claim 13, introducing a second curve. 23. Implant according to any one of the preceding claims, wherein manipulation of the forming element reshapes the body into a "w" configuration. 24. An implant according to any one of the preceding claims, further comprising a coating on the body. A method of operating a mitral valve,
Providing a catheter having a prosthesis thereon, the prosthesis having a first tissue fixation device and a second tissue fixation device;
Inserting the catheter into the venous system;
Transluminally advancing the prosthesis into the coronary sinus;
Attaching the first and second tissue fixation devices to the wall of the coronary sinus;
Manipulating the prosthesis such that a lateral force is applied between the first and second tissue fixation devices on the wall of the coronary sinus.

Images