Fixed anchor and pull mitral valve device and method

Information

  • Patent Grant
  • 9408695
  • Patent Number
    9,408,695
  • Date Filed
    Thursday, January 17, 2008
    16 years ago
  • Date Issued
    Tuesday, August 9, 2016
    8 years ago
Abstract
A device affects the mitral valve annulus geometry of a heart. The device includes a first anchor configured to be positioned within and anchored to the coronary sinus of the heart adjacent the mitral valve annulus within the heart and a second anchor configured to be positioned within the coronary sinus of the heart proximal to the first anchor and adjacent the mitral valve annulus within the heart. The second anchor, when deployed, anchors against distal movement and is moveable in a proximal direction. The device further includes a connecting member having a fixed length permanently attached to the first and second anchors. As a result, when the first and second anchors are within the coronary sinus with the first anchor anchored in the coronary sinus, the second anchor may be displaced proximally to affect the geometry of the mitral valve annulus and released to maintain the effect on the mitral valve geometry.
Description
FIELD OF THE INVENTION

The present invention generally relates to a device and method for treating dilated cardiomyopathy of a heart. The present invention more particularly relates to a device and method for reshaping the mitral valve annulus.


BACKGROUND OF THE INVENTION

The human heart generally includes four valves. Of these valves, a most critical one is known as the mitral valve. The mitral valve is located in the left atrial ventricular opening between the left atrium and left ventricle. The mitral valve is intended to prevent regurgitation of blood from the left ventricle into the left atrium when the left ventricle contracts. In preventing blood regurgitation the mitral valve must be able to withstand considerable back pressure as the left ventricle contracts.


The valve cusps of the mitral valve are anchored to muscular wall of the heart by delicate but strong fibrous cords in order to support the cusps during left ventricular contraction. In a healthy mitral valve, the geometry of the mitral valve ensures that the cusps overlie each other to preclude regurgitation of the blood during left ventricular contraction.


The normal functioning of the mitral valve in preventing regurgitation can be impaired by dilated cardiomyopathy caused by disease or certain natural defects. For example, certain diseases may cause dilation of the mitral valve annulus. This can result in deformation of the mitral valve geometry to cause ineffective closure of the mitral valve during left ventricular contraction. Such ineffective closure results in leakage through the mitral valve and regurgitation. Diseases such as bacterial inflammations of the heart or heart failure can cause the aforementioned distortion or dilation of the mitral valve annulus. Needless to say, mitral valve regurgitation must not go uncorrected.


One method of repairing a mitral valve having impaired function is to completely replace the valve. This method has been found to be particularly suitable for replacing a mitral valve when one of the cusps has been severely damaged or deformed. While the replacement of the entire valve eliminates the immediate problem associated with a dilated mitral valve annulus, presently available prosthetic heart valves do not possess the same durability as natural heart valves.


Various other surgical procedures have been developed to correct the deformation of the mitral valve annulus and thus retain the intact natural heart valve function. These surgical techniques involve repairing the shape of the dilated or deformed valve annulus. Such techniques, generally known as annuloplasty, require surgically restricting the valve annulus to minimize dilation. Here, a prosthesis is typically sutured about the base of the valve leaflets to reshape the valve annulus and restrict the movement of the valve annulus during the opening and closing of the mitral valve.


Many different types of prostheses have been developed for use in such surgery. In general, prostheses are annular or partially annular shaped members which fit about the base of the valve annulus. The annular or partially annular shaped members may be formed from a rigid material, such as a metal, or from a flexible material.


While the prior art methods mentioned above have been able to achieve some success in treating mitral regurgitation, they have not been without problems and potential adverse consequences. For example, these procedures require open heart surgery. Such procedures are expensive, are extremely invasive requiring considerable recovery time, and pose the concomitant mortality risks associated with such procedures. Moreover, such open heart procedures are particularly stressful on patients with a comprised cardiac condition. Given these factors, such procedures are often reserved as a last resort and hence are employed late in the mitral regurgitation progression. Further, the effectiveness of such procedures is difficult to assess during the procedure and may not be known until a much later time. Hence, the ability to make adjustments to or changes in the prostheses to obtain optimum effectiveness is extremely limited. Later corrections, if made at all, require still another open heart surgery.


An improved therapy to treat mitral regurgitation without resorting to open heart surgery has recently been proposed. This is rendered possible by the realization that the coronary sinus of a heart is near to and at least partially encircles the mitral valve annulus and then extends into a venous system including the great cardiac vein. As used herein, the term “coronary sinus” is meant to refer to not only the coronary sinus itself but in addition, the venous system associated with the coronary sinus including the great cardiac vein. The therapy contemplates the use of a device introduced into the coronary sinus to reshape and advantageously affect the geometry of the mitral valve annulus.


The device includes a resilient member having a cross sectional dimension for being received within the coronary sinus of the heart and a longitudinal dimension having an unstressed arched configuration when placed in the coronary sinus. The device partially encircles and exerts an inward pressure on the mitral valve. The inward pressure constricts the mitral valve annulus, or at least a portion of it, to essentially restore the mitral valve geometry. This promotes effective valve sealing action and eliminates mitral regurgitation.


The device may be implanted in the coronary sinus using only percutaneous techniques similar to the techniques used to implant cardiac leads such as pacemaker leads. One proposed system for implanting the device includes an elongated introducer configured for being releasably coupled to the device. The introducer is preferably flexible to permit it to advance the device into the heart and into the coronary sinus through the coronary sinus ostium. To promote guidance, an elongated sheath is first advanced into the coronary sinus. Then, the device and introducer are moved through a lumen of the sheath until the device is in position within the coronary sinus. Because the device is formed of resilient material, it conforms to the curvatures of the lumen as it is advanced through the sheath. The sheath is then partially retracted to permit the device to assume its unstressed arched configuration. Once the device is properly positioned, the introducer is then decoupled from the device and retracted through the sheath. The procedure is then completed by the retraction of the sheath. As a result, the device is left within the coronary sinus to exert the inward pressure on the mitral valve to restore mitral valve geometry.


The foregoing therapy has many advantages over the traditional open heart surgery approach. Since the device, system and method may be employed in a comparatively noninvasive procedure, mitral valve regurgitation may be treated at an early stage in the mitral regurgitation progression. Further, the device may be placed with relative ease by any minimally invasive cardiologist. Still further, since the heart remains completely intact throughout the procedure, the effectiveness of the procedure may be readily determined. Moreover, should adjustments be deemed desirable, such adjustments may be made during the procedure and before the patient is sent to recovery.


Another approach to treat mitral regurgitation with a device in the coronary sinus is based upon the observation that the application of a localized force against a discrete portion of the mitral valve annulus can terminate mitral regurgitation. This suggests that mitral valve dilation may be localized and nonuniform. Hence, the device applies a force to one or more discrete portions of the atrial wall of the coronary sinus to provide localized mitral valve annulus reshaping instead of generalized reshaping of the mitral valve annulus. Such localized therapy would have all the benefits of the generalized therapy. In addition, a localized therapy device may be easier to implant and adjust.


A still further approach to treat mitral regurgitation from the coronary sinus of the heart contemplates a device having a first anchor configured to be positioned within and fixed to the coronary sinus of the heart adjacent the mitral valve annulus within the heart, a cable fixed to the first anchor and extending proximally from the first anchor within the heart, a second anchor configured to be positioned in and fixed in the heart proximal to the first anchor and arranged to slidingly receive the cable, and a lock that locks the cable on the second anchor. When the first and second anchors are fixed within the heart, the cable may be drawn proximally and locked on the second anchor. The geometry of the mitral valve is thereby affected. This approach provides flexibility in that the second anchor may be positioned and fixed in the coronary sinus or alternatively, the second anchor may be positioned and fixed in the right atrium. This approach further allows adjustments in the cable tension after implant. The present invention provides a still further alternative for treating mitral regurgitation with a device placed in the coronary sinus adjacent to the mitral valve annulus.


SUMMARY OF THE INVENTION

The present invention provides a device that affects mitral valve annulus geometry of a heart. The device includes a first anchor configured to be positioned within and anchored to the coronary sinus of the heart adjacent the mitral valve annulus within the heart, and a second anchor configured to be positioned within the heart proximal to the first anchor and adjacent the mitral valve annulus within the heart. The device further includes a connecting member having a fixed length permanently attached to the first and second anchors. As a result, when the first and second anchors are within the heart with the first anchor anchored in the coronary sinus, the second anchor may be displaced proximally to affect the geometry of the mitral valve annulus and released to maintain the effect on the mitral valve geometry. The second anchor may be configured, when deployed, to anchor against distal movement but be moveable proximally to permit the second anchor to be displaced proximally within the coronary sinus.


The first anchor and the second anchor are preferably self-deploying upon release in the coronary sinus or may be deployable after placement. Further, the connecting member, in being of fixed length, has a maximum extended length and as such may be a rigid member, have an initial arcuate configuration, include a spring, having a maximum length or be flexible but not stretchable.


The present invention further provides a device for affecting mitral valve annulus geometry of a heart. The device includes first anchor means for anchoring in the coronary sinus of the heart adjacent the mitral valve annulus, and second anchor means for being deployed within the heart proximal to the first anchor means and adjacent the mitral valve annulus, and connecting means having a fixed length and permanently connecting the first anchor means to the second anchor means. As a result, when the first and second anchor means are within the heart with the first anchor means anchored in the coronary sinus, the second anchor means may be displaced proximally for cooperating with the first anchor means and the connecting means for affecting the geometry of the mitral valve annulus and released for maintaining the effect on the mitral valve geometry.


The invention further provides a system that affects mitral valve annulus geometry of a heart. The system includes a mitral valve device including a first anchor configured to be positioned within and anchored to the coronary sinus of the heart adjacent the mitral valve annulus within the heart, a second anchor configured to be positioned within the heart proximal to the first anchor and adjacent the mitral valve annulus within the heart, and a connecting member having a fixed length permanently attached to the first and second anchors.


The system further includes a catheter having a distal end, a proximal end and a lumen that receives the device, the catheter being guidable into the coronary sinus adjacent to the mitral valve annulus and deploying the first and second anchors of the device within the coronary sinus adjacent to the mitral valve annulus, and a tether releasably coupled to the second anchor and extending proximally through the lumen and out of the catheter proximal end. As a result, when the first anchor is deployed by the catheter in the coronary sinus, the second anchor may be displaced proximally by proximally pulling on the tether to affect the geometry of the mitral valve annulus and thereafter released for deployment to maintain the effect on the mitral valve geometry.


The present invention further provides a method of affecting mitral valve annulus geometry in a heart. The method includes the steps of fixing a first anchor within the coronary sinus of the heart adjacent to the mitral valve annulus, positioning a second anchor within the coronary sinus adjacent to the mitral valve annulus and proximal to the first anchor, fixing a fixed length connecting member between the first anchor and the second anchor, displacing the second anchor proximally to affect the geometry of the mitral valve annulus, and releasing the second anchor from further proximal displacement to maintain the effect on the mitral valve geometry.


The present invention further provides a device that affects mitral valve annulus geometry of a heart. The device includes a first anchor configured to be positioned within and anchored to the coronary sinus of the heart adjacent the mitral valve annulus within the heart, a second anchor configured to be positioned within the heart proximal to the first anchor and adjacent the mitral valve annulus within the heart, and a connecting member attached between the first and second anchors. At least one of the first and second anchors anchoring against movement in a first direction and being moveable in a second direction opposite the first direction.


The at least one anchor may be the first anchor wherein the first direction is a proximal direction and wherein the second direction is a distal direction. The at least one anchor may be the second anchor wherein the first direction is a distal direction and wherein the second direction is a proximal direction. In a preferred embodiment, the first anchor anchors against movement in a proximal direction and is moveable in a distal direction and the second anchor anchors against movement in the distal direction and is moveable in the proximal direction.


The invention still further provides a device that affects mitral valve annulus geometry of a heart and which permits a cardiac lead to be implanted in the left side of the heart. The device includes a first anchor configured to be positioned within and anchored to the coronary sinus of the heart adjacent the mitral valve annulus within the heart, a second anchor configured to be positioned within the heart proximal to the first anchor and adjacent the mitral valve annulus within the heart, and a connecting member attached between the first and second anchors. The first anchor is configured to occupy less than all of the coronary sinus to permit a cardiac lead to be passed by the first anchor.


The first anchor may include a loop through which the cardiac lead may be passed. The second anchor may be positionable within the coronary sinus and be configured to occupy less than all of the coronary sinus to permit the cardiac lead to be passed by the second anchor. The second anchor may also include a loop through which the cardiac lead may be passed.





BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further aspects and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:



FIG. 1 is a superior view of a human heart with the atria removed;



FIG. 2 is a superior view of a human heart similar to FIG. 1 illustrating a deployed mitral valve device embodying the present invention;



FIG. 3 is a superior view of a human heart similar to FIG. 2 illustrating a first step in the deployment of the mitral valve device of FIG. 2 embodying the present invention;



FIG. 4 is a view similar to FIG. 3 illustrating a further step in the deployment of the device of FIG. 2;



FIG. 5 is a view similar to FIG. 3 illustrating a final step in the deployment of the device of FIG. 2;



FIG. 6 is a superior view of a human heart similar to FIG. 1 illustrating another deployed mitral valve device embodying the present invention; and



FIG. 7 is a side view with a portion broken away illustrating further details of device anchors and the manner in which they permit an implantable lead to pass thereby.





DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, it is a superior view of a human heart 10 with the atria removed to expose the mitral valve 12, the coronary sinus 14, the coronary artery 15, and the circumflex artery 17 of the heart 10 to lend a better understanding of the present invention. Also generally shown in FIG. 1 are the pulmonary valve 22, the aortic valve 24, and the tricuspid valve 26 of the heart 10.


The mitral valve 12 includes an anterior cusp 16, a posterior cusp 18 and an annulus 20. The annulus encircles the cusps 16 and 18 and maintains their spacing to provide a complete closure during a left ventricular contraction. As is well known, the coronary sinus 14 partially encircles the mitral valve 12 adjacent to the mitral valve annulus 20. As is also known, the coronary sinus is part of the venous system of the heart and extends along the AV groove between the left atrium and the left ventricle. This places the coronary sinus essentially within the same plane as the mitral valve annulus making the coronary sinus available for placement of the mitral valve therapy device of the present invention therein.



FIG. 2 shows a mitral valve therapy device 30 embodying the present invention. As may be noted in FIG. 2, the device 30 includes a first anchor 32, a connecting member 34, and a second anchor 36. The anchors 32 and 36 and the connecting member 34 may be formed from the same material to provide an integral structure.


The first anchor 32 is located at the distal end of the device 30. The anchor 32 is hook-shaped so as to be self-deployable when released in the coronary sinus 14. More specifically, the device 30 may be formed of most any biocompatible material such as stainless steel, Nitinol, a nickel/titanium alloy of the type well known in the art having shape memory or plastic. The hook-shaped configuration of the anchor 32 thus expands when released to wedge against the inner wall of the coronary sinus 14 for anchoring or fixing the anchor 32 against at least proximal movement. The anchor 32 may however allow distal movement. Preferably, the anchor 32 is positioned just proximally to the crossover point 19 of the coronary sinus 14 and a circumflex artery 17.


The connecting member 34, by being formed of Nitinol, is relatively rigid and is predisposed to have an arcuate configuration to generally correspond to the shape of the mitral valve annulus 20. The connecting member 34 is of a fixed length and is permanently attached to the first and second anchors 32 and 36. Here it will be noted that the second anchor is positioned within the coronary sinus just distal to the ostium 21 of the coronary sinus 14. The second anchor 36 may have a similar hook-shaped configuration and is also preferably self-expanding to be self-deployable. The hook-shape of the anchor 36 anchors or fixes the anchor 36 against distal movement but permits the anchor to be pulled proximally. This is a particularly significant aspect of the device 30 because it permits the device to be adjusted after the anchors 32 and 36 are first deployed.


When the device 30 is deployed as shown in FIG. 2, the first anchor 32 is fixed against proximal movement within the coronary sinus 14. The connecting member 34 then extends proximally from the first anchor 32 to the second anchor 36. The second anchor 36 is then positioned in its desired location within the coronary sinus 14 proximal to the first anchor 32 and permitted to self-expand for being anchored against distal movement. Then, the second anchor 36 is pulled proximally while the first anchor 32 is held in its fixed position. This creates tension in the connecting member 34 to affect the geometry of the mitral valve annulus 20. Once a desired amount of tension is applied to the connecting member 34, the second anchor 36 is released from further movement and is redeployed against distal movement. With the connecting member 34 now under maintained tension, the advantageously affected geometry of the mitral valve annulus 20 is now preserved. The tension in the cable is preferably adjusted by the pulling on the second anchor 26 while monitoring a parameter indicative of mitral regurgitation, such as Doppler echo.


The connecting member 34 may be provided with a covering (not shown). The covering may preferably be formed of a compressible material to serve to cushion the forces of the connecting member applied against the inner wall of the coronary sinus 14.



FIGS. 3 through 5 show a manner in which the device 30 may be deployed by a deployment assembly 50. As will be noted in FIG. 3, the deployment assembly 50 includes a catheter 52 and a tether 54. The catheter 52 has a lumen 56 dimensioned for slidably receiving the device 30 in its predeployed state with the tether 54 looped around the second anchor 36 and extending out the proximal end of the catheter 52.


As will be noted in FIG. 3, the first anchor 32 has been deployed while the second anchor remains in the catheter lumen 56. This may be accompanied by feeding the catheter 52 into the coronary sinus until the first anchor is in a desired position. Now, the catheter 52 may be moved proximally while maintaining the first anchor 32 against movement. Proximal movement of the catheter 52 will release the anchor 32. When the anchor is released, it will self-expand to self-deploy and be fixed against proximal movement.


As shown in FIG. 4, the catheter 52 is further retracted to release the second anchor 36 to permit it to self-expand and to self-deploy. The second anchor 36 is now fixed against distal movement but permitted to move proximally. The tether 54 continues to extend out the proximal end of the catheter 52.


As may now be further seen in FIG. 5, tension is then applied to the connecting member 34 by proximally pulling on the tether 54, and hence the second anchor 36, while the first anchor 32 resists proximal movement. When the desired tension is placed on the connecting member 34, the second anchor 36 is released for re-self-deployment. When this is completed, the first anchor 32 and the second anchor 36 are fixed in position with a tension in the connecting member 34. The catheter 52 and the tether 54 may then be removed to complete the deployment process. Although the proximal anchor 36 is shown to be finally deployed in the coronary sinus, it will be appreciated by those skilled in the art that the proximal anchor 36, after being displaced proximally, may finally be deployed within the right atrium just proximal to the ostium 21 of the coronary sinus 14. Hence, any final position of the proximal anchor 36 proximal to the distal anchor 32 and within the heart is contemplated in accordance with the present invention.


In accordance with the present invention, the device 30 may be deployed in a slightly different manner as described above. Here, the first anchor 32 may be deployed as described above and the second anchor 36 left in the catheter 52 as it is moved proximally. When the second anchor 36 reaches a desired position, the catheter 52 may then be pulled back to release and deploy the second anchor 36. As a result, in accordance with this alternative embodiment, the second anchor, when deployed, may anchor against both distal and proximal movement.



FIG. 6 shows another mitral valve device 70 embodying the present invention. The device 70 is similar to the device 30 previously described except that its connecting member 74 includes a spring configuration 75. The spring 75 has a maximum length and serves to more forcefully maintain the applied tension on the mitral valve annulus 20. To this end, the device 70 includes a first anchor 72, the connecting member 74, and a second anchor 76.


The first and second anchors 72 and 76 are again configured so that when they are released, they self-expand, to wedge against the inner wall of the coronary sinus 14. Again, the first anchor resists proximal movement and the second anchor 76 resists distal movement. In all other respects, the device 70 may be identical to and deployed in the same manner as the device 30.


Implantable cardiac stimulation devices are well known in the art. Such devices may include, for example, implantable cardiac pacemakers and defibrillators. The devices are generally implanted in a pectoral region of the chest beneath the skin of a patient within what is known as a subcutaneous pocket. The implantable devices generally function in association with one or more electrode carrying leads which are implanted within the heart. The electrodes are usually positioned within the right side of the heart, either within the right ventricle or right atrium, or both, for making electrical contact with their respective heart chamber. Conductors within the leads and a proximal connector carried by the leads couple the electrodes to the device to enable the device to sense cardiac electrical activity and deliver the desired therapy.


Traditionally, therapy delivery had been limited to the venous, or right side of the heart. The reason for this is that implanted electrodes can cause blood clot formation in some patients. If a blood clot were released arterially from the left heart, as for example the left ventricle, it could pass directly to the brain potentially resulting in a paralyzing or fatal stroke. However, a blood clot released from the right heart, as from the right ventricle, would pass into the lungs where the filtering action of the lungs would prevent a fatal or debilitating embolism in the brain.


Recently, new lead structures and methods have been proposed and even practiced for delivering cardiac rhythm management therapy to the left heart. These lead structures and methods avoid direct electrode placement within the left atrium and left ventricle of the heart by lead implantation within the coronary sinus of the heart. As previously mentioned, the phrase “coronary sinus” refers to not only the coronary sinus itself but in addition, the venous system associated with the coronary sinus including the great cardiac vein.


It has been demonstrated that electrodes placed in the coronary sinus region of the heart may be used for left atrial pacing, left ventricular pacing, or cardioversion and defibrillation. These advancements enable implantable cardiac stimulation devices to address the needs of a patient population with left ventricular dysfunction and/or congestive heart failure which would benefit from left heart side pacing, either alone or in conjunction with right heart side pacing (bi-chamber pacing), and/or defibrillation.


Even though the device of the present invention is implantable in the coronary sinus of the heart, it is configured in accordance with further aspects of the present invention to permit a cardiac lead to pass through the coronary sinus for functioning as described above. To that end, and as best seen in FIG. 7, the anchors 32 and 36 of the device 30 occupy only a small portion of and hence less than all of the interior space of the coronary sinus 14. This permits a cardiac lead 80 to be advanced into the coronary sinus 14 for implant in the left side of the heart.


More specifically, the anchors 32 and 36 take the form of loops 33 and 35 respectively which are then bent backwards on the device to form the previously referred to hook-shapes for self-deployment. The loops 33 and 35 thus permit the cardiac lead 80 to be passed therethrough for implant in the left heart. This is particularly desirable because many patients suffering from mitral regurgitation may also be candidates for left heart cardiac rhythm management therapy.


While particular embodiments of the present invention have been shown and described, modifications may be made, and it is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention as defined by the appended claims.

Claims
  • 1. A method of minimally-invasively treating mitral valve regurgitation, the method comprising: advancing a delivery device to a patient's coronary sinus, the delivery device comprising a catheter;advancing an intraluminal cardiac device in a collapsed configuration through a lumen of the catheter into the coronary sinus with the delivery device releasably secured to a proximal end of the intraluminal cardiac device, the intraluminal cardiac device comprising a distal expandable anchor, a proximal expandable anchor, and a fixed length connecting member extending between the distal and proximal expandable anchors, wherein advancing the intraluminal cardiac device comprises advancing the intraluminal cardiac device with the distal and proximal expandable anchors in collapsed delivery configurations, wherein at least one of the proximal and distal anchors comprises first and second arm segments that extend from one end of the device toward the connecting member and the other anchor when in the collapsed configuration;retracting the catheter proximally within the coronary sinus to cause the distal expandable anchor to self-expand within the coronary sinus;anchoring the distal expandable anchor against movement in the coronary sinus;while maintaining the proximal expandable anchor within the catheter to prevent self-expansion of the proximal expandable anchor, pulling proximally on the catheter and the intraluminal cardiac device such that the connecting member is disposed on an inside curve of the coronary sinus so as to change the geometry of the mitral valve annulus and bring the leaflets of the mitral valve closer together, thereby reducing undesirable blood flow regurgitation back through the mitral valve during the heart cycle;while maintaining the intraluminal cardiac device in place, retracting the catheter proximally within the coronary sinus to cause the proximal expandable anchor to self-expand within the coronary sinus;anchoring the proximal expandable anchor against movement within the coronary sinus to substantially secure the mitral valve annulus in the changed geometry,whereby anchoring the anchor comprising the first and second arm segments causes the first and second arm segments to extend radially outwardly and fix against the wall of the coronary sinus such that the first and second arm segments extend away from one another toward the connector, and meet one another at a location axially spaced from the one end of the device; andreleasing the proximal end of the intraluminal device and withdrawing the catheter from the coronary sinus.
  • 2. The method of claim 1 wherein the distal anchor comprises the first and second arms segments and the one end comprises the distal end, such that upon anchoring of the distal anchor the first and second arm segments extend away from one another at the distal end of the device, proximally toward the connector, and meet one another at a location proximal to the distal end.
  • 3. The method of claim 1 wherein the proximal anchor comprises the first and second arms segments and the one end comprises the proximal end, such that upon anchoring of the proximal anchor the first and second arm segments extend away from one another at the proximal end of the device, distally toward the connector, and meet one another at a location distal to the proximal end.
  • 4. The method of claim 1 wherein, when the distal and proximal anchor are anchored in the coronary sinus, the first and second arm segments meet one another and engage the coronary sinus wall at a location in the coronary sinus across from the connecting member that is disposed on the inside curve of the coronary sinus.
  • 5. A method of minimally-invasively treating mitral valve regurgitation, the method comprising: advancing a device within a catheter to a patient's coronary sinus, the device comprising a distal expandable anchor, a proximal expandable anchor, and a fixed length connecting member extending between the distal and proximal expandable anchors;anchoring the distal expandable anchor against the coronary sinus wall in a configuration in which first and second arms of the distal expandable anchor extend away from one another at a distal end of the device, proximally towards the connector, and meet one another at a location proximal to the distal end of the device; andanchoring the proximal expandable anchor against the coronary sinus wall in a configuration in which first and second arms of the proximal expandable anchor extend away from one another at a proximal end of the device, distally towards the connector, and meet one another at a location distal to the proximal end of the device.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 11/132,788, filed May 18, 2005, now abandoned; which is a continuation of application Ser. No. 10/066,426, filed Jan. 30, 2002, now U.S. Pat. No. 6,976,995. These applications are incorporated by reference in their entirety as if fully set forth herein.

US Referenced Citations (238)
Number Name Date Kind
3620212 Fannon, Jr. et al. Nov 1971 A
3786806 Johnson et al. Jan 1974 A
3890977 Wilson Jun 1975 A
3974526 Dardik et al. Aug 1976 A
3995623 Blake et al. Dec 1976 A
4055861 Carpentier et al. Nov 1977 A
4164046 Cooley Aug 1979 A
4485816 Krumme Dec 1984 A
4550870 Krumme et al. Nov 1985 A
4588395 Lemelson May 1986 A
4830023 de Toledo et al. May 1989 A
5061277 Carpentier et al. Oct 1991 A
5099838 Bardy Mar 1992 A
5104404 Wolff Apr 1992 A
5197978 Hess Mar 1993 A
5250071 Palermo Oct 1993 A
5261916 Engelson Nov 1993 A
5265601 Mehra Nov 1993 A
5344426 Lau et al. Sep 1994 A
5350420 Cosgrove et al. Sep 1994 A
5411549 Peters May 1995 A
5433727 Sideris Jul 1995 A
5441515 Khosravi et al. Aug 1995 A
5449373 Pinchasik et al. Sep 1995 A
5454365 Bonutti Oct 1995 A
5458615 Klemm et al. Oct 1995 A
5474557 Mai Dec 1995 A
5507295 Skidmore Apr 1996 A
5507802 Imran Apr 1996 A
5514161 Limousin May 1996 A
5554177 Kieval et al. Sep 1996 A
5562698 Parker Oct 1996 A
5575818 Pinchuk Nov 1996 A
5584867 Limousin et al. Dec 1996 A
5601600 Ton Feb 1997 A
5617854 Munsif Apr 1997 A
5662703 Yurek et al. Sep 1997 A
5676671 Inoue Oct 1997 A
5733325 Robinson et al. Mar 1998 A
5733328 Fordenbacher Mar 1998 A
5741297 Simon Apr 1998 A
5752969 Cunci et al. May 1998 A
5800519 Sandock Sep 1998 A
5824071 Nelson et al. Oct 1998 A
5836882 Frazin Nov 1998 A
5871501 Leschinsky et al. Feb 1999 A
5891193 Robinson et al. Apr 1999 A
5895391 Farnholtz Apr 1999 A
5899882 Waksman et al. May 1999 A
5908404 Elliot Jun 1999 A
5928258 Khan et al. Jul 1999 A
5935161 Robinson et al. Aug 1999 A
5954761 Machek et al. Sep 1999 A
5961545 Lentz et al. Oct 1999 A
5978705 KenKnight et al. Nov 1999 A
5984944 Forber Nov 1999 A
6007519 Rosselli Dec 1999 A
6015402 Sahota Jan 2000 A
6022371 Killion Feb 2000 A
6027517 Crocker et al. Feb 2000 A
6045497 Schweich, Jr. et al. Apr 2000 A
6053900 Brown et al. Apr 2000 A
6056775 Borghi et al. May 2000 A
6077295 Limon et al. Jun 2000 A
6077297 Robinson et al. Jun 2000 A
6080182 Shaw et al. Jun 2000 A
6086611 Duffy et al. Jul 2000 A
6096064 Routh Aug 2000 A
6099549 Bosma et al. Aug 2000 A
6099552 Adams Aug 2000 A
6129755 Mathis et al. Oct 2000 A
6162168 Schweich, Jr. et al. Dec 2000 A
6171320 Monassevitch Jan 2001 B1
6183512 Howanec et al. Feb 2001 B1
6190406 Duerig et al. Feb 2001 B1
6200336 Pavcnik et al. Mar 2001 B1
6210432 Solem et al. Apr 2001 B1
6228098 Kayan et al. May 2001 B1
6241757 An et al. Jun 2001 B1
6254628 Wallace et al. Jul 2001 B1
6267783 Letendre et al. Jul 2001 B1
6275730 KenKnight et al. Aug 2001 B1
6306141 Jervis Oct 2001 B1
6312446 Huebsch et al. Nov 2001 B1
6334864 Amplatz et al. Jan 2002 B1
6342067 Mathis et al. Jan 2002 B1
6345198 Mouchawar et al. Feb 2002 B1
6352553 van der Burg et al. Mar 2002 B1
6352561 Leopold et al. Mar 2002 B1
6358195 Green et al. Mar 2002 B1
6368345 Dehdashtian et al. Apr 2002 B1
6395017 Dwyer et al. May 2002 B1
6402781 Langberg et al. Jun 2002 B1
6419696 Ortiz et al. Jul 2002 B1
6442427 Boute et al. Aug 2002 B1
6464720 Boatman et al. Oct 2002 B2
6478776 Rosenman et al. Nov 2002 B1
6503271 Duerig et al. Jan 2003 B2
6537314 Langberg et al. Mar 2003 B2
6556873 Smits Apr 2003 B1
6562067 Mathis May 2003 B2
6569198 Wilson et al. May 2003 B1
6589208 Ewers et al. Jul 2003 B2
6599314 Mathis et al. Jul 2003 B2
6602288 Cosgrove et al. Aug 2003 B1
6602289 Colvin et al. Aug 2003 B1
6623521 Steinke et al. Sep 2003 B2
6626899 Houser et al. Sep 2003 B2
6629534 Dell et al. Oct 2003 B1
6629994 Gomez et al. Oct 2003 B2
6643546 Mathis et al. Nov 2003 B2
6648881 KenKnight et al. Nov 2003 B2
6652538 Kayan et al. Nov 2003 B2
6656221 Taylor et al. Dec 2003 B2
6676702 Mathis Jan 2004 B2
6689164 Seguin Feb 2004 B1
6709425 Gambale et al. Mar 2004 B2
6716158 Raman et al. Apr 2004 B2
6718985 Hlavka et al. Apr 2004 B2
6721598 Helland et al. Apr 2004 B1
6723038 Schroeder et al. Apr 2004 B1
6733521 Chobotov et al. May 2004 B2
6743219 Dwyer et al. Jun 2004 B1
6764510 Vidlund et al. Jul 2004 B2
6773446 Dwyer et al. Aug 2004 B1
6776784 Ginn Aug 2004 B2
6790231 Liddicoat et al. Sep 2004 B2
6793673 Kowalsky et al. Sep 2004 B2
6797001 Mathis et al. Sep 2004 B2
6800090 Alferness et al. Oct 2004 B2
6805128 Pless et al. Oct 2004 B1
6810882 Langberg et al. Nov 2004 B2
6821297 Snyders Nov 2004 B2
6824562 Mathis et al. Nov 2004 B2
6881220 Edwin et al. Apr 2005 B2
6890353 Cohn et al. May 2005 B2
6899734 Castro et al. May 2005 B2
6908478 Alferness et al. Jun 2005 B2
6926690 Renati Aug 2005 B2
6935404 Duerig et al. Aug 2005 B2
6949122 Adams et al. Sep 2005 B2
6955689 Ryan et al. Oct 2005 B2
6960229 Mathis et al. Nov 2005 B2
6964683 Kowalsky et al. Nov 2005 B2
6966926 Mathis Nov 2005 B2
6976995 Mathis et al. Dec 2005 B2
7152605 Khairkhahan et al. Dec 2006 B2
7175653 Gaber Feb 2007 B2
20010018611 Solem et al. Aug 2001 A1
20010041899 Foster Nov 2001 A1
20010044568 Langberg et al. Nov 2001 A1
20010049558 Liddicoat et al. Dec 2001 A1
20020016628 Langberg et al. Feb 2002 A1
20020042621 Liddicoat et al. Apr 2002 A1
20020042651 Liddicoat et al. Apr 2002 A1
20020049468 Streeter et al. Apr 2002 A1
20020055774 Liddicoat May 2002 A1
20020065554 Streeter May 2002 A1
20020087173 Alferness et al. Jul 2002 A1
20020095167 Liddicoat et al. Jul 2002 A1
20020138044 Streeter et al. Sep 2002 A1
20020151961 Lashinski et al. Oct 2002 A1
20020156526 Hlavka et al. Oct 2002 A1
20020161377 Rabkin et al. Oct 2002 A1
20020183837 Streeter et al. Dec 2002 A1
20020183838 Liddicoat et al. Dec 2002 A1
20020183841 Cohn et al. Dec 2002 A1
20020188170 Santamore et al. Dec 2002 A1
20030018358 Saadat Jan 2003 A1
20030040771 Hyodoh et al. Feb 2003 A1
20030069636 Solem et al. Apr 2003 A1
20030078465 Pai et al. Apr 2003 A1
20030078654 Taylor et al. Apr 2003 A1
20030083613 Schaer May 2003 A1
20030088305 Van Schie et al. May 2003 A1
20030130730 Cohn et al. Jul 2003 A1
20030171776 Adams et al. Sep 2003 A1
20030236569 Mathis et al. Dec 2003 A1
20040010305 Alferness et al. Jan 2004 A1
20040019377 Taylor et al. Jan 2004 A1
20040039443 Solem et al. Feb 2004 A1
20040102840 Solem et al. May 2004 A1
20040111095 Gordon et al. Jun 2004 A1
20040133240 Adams et al. Jul 2004 A1
20040153147 Mathis Aug 2004 A1
20040158321 Reuter et al. Aug 2004 A1
20040176840 Langberg Sep 2004 A1
20040193260 Alferness et al. Sep 2004 A1
20040220654 Mathis et al. Nov 2004 A1
20040220657 Nieminen et al. Nov 2004 A1
20040249452 Adams et al. Dec 2004 A1
20040260342 Vargas et al. Dec 2004 A1
20050004667 Swinford et al. Jan 2005 A1
20050010240 Mathis et al. Jan 2005 A1
20050021121 Reuter et al. Jan 2005 A1
20050027351 Reuter et al. Feb 2005 A1
20050027353 Alferness et al. Feb 2005 A1
20050033419 Alferness et al. Feb 2005 A1
20050038507 Alferness et al. Feb 2005 A1
20050060030 Lashinski et al. Mar 2005 A1
20050065598 Mathis et al. Mar 2005 A1
20050096666 Gordon et al. May 2005 A1
20050096740 Langberg et al. May 2005 A1
20050119673 Gordon et al. Jun 2005 A1
20050137449 Nieminen et al. Jun 2005 A1
20050137450 Aronson et al. Jun 2005 A1
20050137451 Gordon et al. Jun 2005 A1
20050137685 Nieminen et al. Jun 2005 A1
20050149179 Mathis et al. Jul 2005 A1
20050149180 Mathis et al. Jul 2005 A1
20050149182 Alferness et al. Jul 2005 A1
20050187619 Mathis et al. Aug 2005 A1
20050197692 Pai et al. Sep 2005 A1
20050197693 Pai et al. Sep 2005 A1
20050197694 Pai et al. Sep 2005 A1
20050209690 Mathis et al. Sep 2005 A1
20050216077 Mathis et al. Sep 2005 A1
20050261704 Mathis Nov 2005 A1
20050272969 Alferness et al. Dec 2005 A1
20060020335 Kowalsky et al. Jan 2006 A1
20060030882 Adams et al. Feb 2006 A1
20060041305 Lauterjung Feb 2006 A1
20060116758 Swinford et al. Jun 2006 A1
20060142854 Alferness et al. Jun 2006 A1
20060161169 Nieminen et al. Jul 2006 A1
20060167544 Nieminen et al. Jul 2006 A1
20060173536 Mathis et al. Aug 2006 A1
20060191121 Gordon Aug 2006 A1
20060271174 Nieminen et al. Nov 2006 A1
20060276891 Nieminen et al. Dec 2006 A1
20070055293 Alferness et al. Mar 2007 A1
20070066879 Mathis et al. Mar 2007 A1
20070135912 Mathis Jun 2007 A1
20070239270 Mathis et al. Oct 2007 A1
20110308367 Hayner et al. Dec 2011 A1
20120123532 Mathis May 2012 A1
20120197389 Alferness et al. Aug 2012 A1
20150173901 Nieminen et al. Jun 2015 A1
Foreign Referenced Citations (43)
Number Date Country
0893133 Jan 1999 EP
0903110 Mar 1999 EP
0968688 Jan 2000 EP
1050274 Nov 2000 EP
1095634 May 2001 EP
1177779 Feb 2002 EP
2181670 May 2010 EP
0741604 Dec 1955 GB
2754067 Mar 1998 JP
2000-308652 Nov 2000 JP
2001-503291 Mar 2001 JP
2003-503101 Jan 2003 JP
2003-521310 Jul 2003 JP
WO 9856435 Dec 1998 WO
WO 0044313 Aug 2000 WO
WO 0060995 Oct 2000 WO
WO 0074603 Dec 2000 WO
WO 0100111 Jan 2001 WO
WO 0119292 Mar 2001 WO
WO 0150985 Jul 2001 WO
WO 0154618 Aug 2001 WO
WO 0187180 Nov 2001 WO
WO 0200099 Jan 2002 WO
WO 0201999 Jan 2002 WO
WO 0205888 Jan 2002 WO
WO 0219951 Mar 2002 WO
WO 0234118 May 2002 WO
WO 0247539 Jun 2002 WO
WO 02053206 Jul 2002 WO
WO 02060352 Aug 2002 WO
WO 02062263 Aug 2002 WO
WO 02062270 Aug 2002 WO
WO 02062408 Aug 2002 WO
WO 02076284 Oct 2002 WO
WO 02078576 Oct 2002 WO
WO 02096275 Dec 2002 WO
WO 03015611 Feb 2003 WO
WO 03037171 May 2003 WO
WO 03049647 Jun 2003 WO
WO 03049648 Jun 2003 WO
WO 03055417 Jul 2003 WO
WO 03059198 Jul 2003 WO
WO 03063735 Aug 2003 WO
Non-Patent Literature Citations (18)
Entry
Reuter et al.; U.S. Appl. No. 12/642,525 entitled “Adjustable Height Focal Tissue Deflector,” filed Dec. 18, 2009.
Alferness et al.; U.S. Appl. No. 12/719,758 entitled “Device and Method for Modifying the Shape of a Body Organ,” filed Mar. 8, 2010.
Pijls et al.; Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses; The New England J. of Med.; vol. 334; No. 26; pp. 1703-1708; Jun. 27, 1996.
Yamanouchi, et al.; Activation Mapping from the coronary sinus may be limited by anatomic variations; vol. 21 pp. 2522-2526; Nov. 1998.
Nieminen et al; U.S. Appl. No. 12/060,781 entitled “Tissue shaping device,” filed Apr. 1, 2008.
Hayner et al.; U.S. Appl. No. 12/189,527 entitled “Catheter cutting tool,” filed Aug. 11, 2008.
El-Maasarany et al.; The coronary sinus conduit function: Anatomical study (relationship to adjacent structures); http://europace.oxfordjournals.org/cge/content/full/7/5/475.
Mathis et al., U.S. Appl. No. 11/782,490 entitled “Device and method for modifying the shape of a body organ, ” filed Jul. 24, 2007.
Mathis et al., U.S. Appl. No. 11/782,508, entitled “Device and method for modifying the shape of a body organ, ” filed Jul. 24, 2007.
Mathis et al., U.S. Appl. No. 11/782,527 entitled “Device and method for modifying the shape of a body organ, ” filed Jul. 24, 2007.
Mathis et al; U.S. Appl. No. 11/963,417 entitled “Device and method for modifying the shape of a body organ,” filed Dec. 21, 2007.
Gordon et al.; U.S. Appl. No. 11/971,174 entitled “Medical device delivery system,” filed Jan. 8, 2008.
Gray, H. Anatomy of the Human Body. The Systemic Veins. Philadelphia: Lea & Febiger, 1918; Bartleby.com. 2000. Available at www.bartleby.com/107/. Accessed Jun. 7, 2006.
Heartsite.com. Echocardiogram, 1999; p. 1-4. A.S.M. Systems Inc. Available at: http://www.heartsite.com/html/echocardiogram.html. Accessed Jul. 1, 2005.
Papageorgiou, P., et al. Coronary Sinus Pacing Prevents Induction of Atrial Fibrillation. Circulation. 1997; 96(6): 1893-1898.
Pai, Suresh; U.S. Appl. No. 60/329,694 entitled “Percutaneous cardiac support structures and deployment means,” filed Oct. 16, 2001.
Mathis, Mark L.; U.S. Appl. No. 12/838,189 entitled “Mitral Valve Device Using Conditioned Shape Memory Alloy,” filed Jul. 16, 2010.
Pelton et al. Medical uses of nitinol; Material Science Forum; vols. 327-328; pp. 63-70; 2000.
Related Publications (1)
Number Date Country
20080140191 A1 Jun 2008 US
Divisions (1)
Number Date Country
Parent 11132788 May 2005 US
Child 12016054 US
Continuations (1)
Number Date Country
Parent 10066426 Jan 2002 US
Child 11132788 US