Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20050216077 A1
Publication typeApplication
Application numberUS 11/132,788
Publication dateSep 29, 2005
Filing dateMay 18, 2005
Priority dateJan 30, 2002
Also published asCA2469460A1, CA2469460C, CA2760865A1, EP1482869A2, EP1482869A4, US6976995, US7828842, US8974525, US20030144697, US20080140191, US20080319542, US20110035000, US20150173901, WO2003063735A2, WO2003063735A3
Publication number11132788, 132788, US 2005/0216077 A1, US 2005/216077 A1, US 20050216077 A1, US 20050216077A1, US 2005216077 A1, US 2005216077A1, US-A1-20050216077, US-A1-2005216077, US2005/0216077A1, US2005/216077A1, US20050216077 A1, US20050216077A1, US2005216077 A1, US2005216077A1
InventorsMark Mathis, Gregory Nieminen, David Reuter
Original AssigneeMathis Mark L, Nieminen Gregory D, Reuter David G
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Fixed length anchor and pull mitral valve device and method
US 20050216077 A1
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.
Images(5)
Previous page
Next page
Claims(16)
1. A device that affects mitral valve annulus geometry of a heart, comprising:
a first anchor, a second anchor and a connecting member; said first anchor configured to be anchored in a coronary sinus; said second anchor configured to be deployed adjacent the mitral valve annulus; whereby the first anchor is positioned in the coronary sinus and the second anchor is deployed proximal of the first anchor to affect and maintain a desired geometry of the mitral valve annulus.
2. The device of claim 1 wherein the first anchor is anchored proximal to a crossover point located between a coronary sinus and the cimcumflex artery.
3. The device of claim 2 wherein the proximal anchor is positioned in the coronary sinus distal to an ostium of the coronary sinus.
4. The device of claim 3 wherein the connecting member has an arcuate configuration.
5. The device of claim 4 wherein a tension applied to the connecting member affects the geometry of the mitral valve annulus.
6. The device of claim 5 wherein the tension is applied by applying a force on the second anchor.
7. The device of claim 6 wherein the device further comprises a tension applying member releasably coupled to the second anchor.
8. The device of claim 6 wherein a desired level of tension is applied in order to affect a concomitant change in the geometry of the mitral valve annulus.
9. The device of claim 7 wherein the second member is decoupled from the second anchor after the desired change in mitral valve geometry is achieved.
10. The device of claim 8 wherein the desired change in the geometry of the mitral valve annulus is monitored.
11. The device of claim 8 wherein the desired changed in the geometry of the mitral valve annulus is indicated by a change in a patient's mitral valve regurgitation.
12. The device of claim 8 wherein change in the geometry of the mitral valve annulus reduces mitral valve regurgitation.
13. The device of claim 1 wherein the connecting member is configured to be atraumatic.
14. The device of claim 8 wherein the device further comprises a covering.
15. The device of claim 1 wherein the first anchor, the second anchor and connecting members are integral.
16. A device that affects mitral valve annulus geometry of a heart, comprising:
a first anchor configured to be positioned within and anchored to the coronary sinus adjacent the mitral valve annulus;
a second anchor configured to be positioned proximal to the first anchor and adjacent the mitral valve annulus;
a connecting member disposed between the first and second anchors, whereby the first anchor is anchored in the coronary sinus, the second anchor is displaced proximally to affect the geometry of the mitral valve annulus and released to maintain the effect on the mitral valve geometry;
an atraumatic covering; and
at least one loop disposed on the proximal or distal anchor.
Description
CROSS-REFERENCE

This application is a continuation application of Ser. No. 10/066,426 filed Jan. 30, 2002, which is incorporated herein by reference in its entirety and to which application we claim priority under 35 USC 120.

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.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3786806 *Nov 22, 1972Jan 22, 1974F AlicandriThermoconstrictive surgical appliance
US3890977 *Mar 1, 1974Jun 24, 1975Bruce C WilsonKinetic memory electrodes, catheters and cannulae
US4588395 *Oct 28, 1980May 13, 1986Lemelson Jerome HCatheter and method
US4830023 *Nov 27, 1987May 16, 1989Medi-Tech, IncorporatedMedical guidewire
US5099838 *Dec 15, 1988Mar 31, 1992Medtronic, Inc.Endocardial defibrillation electrode system
US5104404 *Jun 20, 1991Apr 14, 1992Medtronic, Inc.Articulated stent
US5507295 *Jun 29, 1993Apr 16, 1996British Technology Group LimitedMedical devices
US5507802 *Oct 7, 1994Apr 16, 1996Cardiac Pathways CorporationMethod of mapping and/or ablation using a catheter having a tip with fixation means
US5514161 *Apr 4, 1995May 7, 1996Ela Medical S.A.Methods and apparatus for controlling atrial stimulation in a double atrial triple chamber cardiac pacemaker
US5601600 *Sep 8, 1995Feb 11, 1997Conceptus, Inc.Endoluminal coil delivery system having a mechanical release mechanism
US5617854 *Jun 22, 1994Apr 8, 1997Munsif; AnandShaped catheter device and method
US5733325 *May 6, 1996Mar 31, 1998C. R. Bard, Inc.Non-migrating vascular prosthesis and minimally invasive placement system
US5741297 *Aug 28, 1996Apr 21, 1998Simon; MorrisDaisy occluder and method for septal defect repair
US5752969 *Jun 16, 1994May 19, 1998Sofamor S.N.C.Instrument for the surgical treatment of an intervertebral disc by the anterior route
US5871501 *Jan 12, 1998Feb 16, 1999Datascope Investment Corp.Guide wire with releasable barb anchor
US5891193 *Apr 11, 1997Apr 6, 1999C.R. Bard, Inc.Non-migrating vascular prosthesis and minimally invasive placement system therefor
US5895391 *Sep 27, 1996Apr 20, 1999Target Therapeutics, Inc.Ball lock joint and introducer for vaso-occlusive member
US5899882 *Apr 4, 1996May 4, 1999Novoste CorporationCatheter apparatus for radiation treatment of a desired area in the vascular system of a patient
US5908404 *Mar 3, 1998Jun 1, 1999Elliott; James B.Methods for inserting an implant
US6015402 *Jun 4, 1998Jan 18, 2000Sahota; HarvinderWire perfusion catheter
US6022371 *Jul 21, 1998Feb 8, 2000Scimed Life Systems, Inc.Locking stent
US6027517 *May 13, 1997Feb 22, 2000Radiance Medical Systems, Inc.Fixed focal balloon for interactive angioplasty and stent implantation catheter with focalized balloon
US6045497 *Jul 29, 1998Apr 4, 2000Myocor, Inc.Heart wall tension reduction apparatus and method
US6053900 *Oct 7, 1998Apr 25, 2000Brown; Joe E.Apparatus and method for delivering diagnostic and therapeutic agents intravascularly
US6059775 *Dec 31, 1997May 9, 2000Nielsen; James M.Multifocal corneal sculpturing
US6077295 *Jul 15, 1996Jun 20, 2000Advanced Cardiovascular Systems, Inc.Self-expanding stent delivery system
US6077297 *Jan 12, 1998Jun 20, 2000C. R. Bard, Inc.Non-migrating vascular prosthesis and minimally invasive placement system therefor
US6080182 *Dec 19, 1997Jun 27, 2000Gore Enterprise Holdings, Inc.Self-expanding defect closure device and method of making and using
US6171320 *Oct 7, 1997Jan 9, 2001Niti Alloys Technologies Ltd.Surgical clip
US6183512 *Apr 16, 1999Feb 6, 2001Edwards Lifesciences CorporationFlexible annuloplasty system
US6190406 *Feb 2, 1999Feb 20, 2001Nitinal Development CorporationIntravascular stent having tapered struts
US6200336 *Jun 2, 1999Mar 13, 2001Cook IncorporatedMultiple-sided intraluminal medical device
US6210432 *Jun 30, 1999Apr 3, 2001Jan Otto SolemDevice and method for treatment of mitral insufficiency
US6228098 *Jul 10, 1998May 8, 2001General Surgical Innovations, Inc.Apparatus and method for surgical fastening
US6334864 *May 17, 2000Jan 1, 2002Aga Medical Corp.Alignment member for delivering a non-symmetric device with a predefined orientation
US6342067 *Jan 9, 1998Jan 29, 2002Nitinol Development CorporationIntravascular stent having curved bridges for connecting adjacent hoops
US6345198 *Jul 29, 1999Feb 5, 2002Pacesetter, Inc.Implantable stimulation system for providing dual bipolar sensing using an electrode positioned in proximity to the tricuspid valve and programmable polarity
US6352553 *Jul 18, 1997Mar 5, 2002Gore Enterprise Holdings, Inc.Stent-graft deployment apparatus and method
US6352561 *Dec 23, 1996Mar 5, 2002W. L. Gore & AssociatesImplant deployment apparatus
US6358195 *Mar 9, 2000Mar 19, 2002Neoseed Technology LlcMethod and apparatus for loading radioactive seeds into brachytherapy needles
US6395017 *Nov 15, 1996May 28, 2002C. R. Bard, Inc.Endoprosthesis delivery catheter with sequential stage control
US6503271 *Dec 7, 2000Jan 7, 2003Cordis CorporationIntravascular device with improved radiopacity
US6537314 *Jan 30, 2001Mar 25, 2003Ev3 Santa Rosa, Inc.Percutaneous mitral annuloplasty and cardiac reinforcement
US6556873 *Nov 29, 1999Apr 29, 2003Medtronic, Inc.Medical electrical lead having variable bending stiffness
US6562066 *Mar 2, 2001May 13, 2003Eric C. MartinStent for arterialization of the coronary sinus and retrograde perfusion of the myocardium
US6562067 *Jun 8, 2001May 13, 2003Cordis CorporationStent with interlocking elements
US6565221 *Nov 21, 2001May 20, 2003Buehler Motor GmbhAdjusting device for a motor vehicle mirror with contactor
US6569198 *Mar 30, 2001May 27, 2003Richard A. WilsonMitral or tricuspid valve annuloplasty prosthetic device
US6676702 *May 14, 2001Jan 13, 2004Cardiac Dimensions, Inc.Mitral valve therapy assembly and method
US6689164 *Oct 10, 2000Feb 10, 2004Jacques SeguinAnnuloplasty device for use in minimally invasive procedure
US6709425 *Jan 31, 2001Mar 23, 2004C. R. Bard, Inc.Vascular inducing implants
US6716158 *Sep 6, 2002Apr 6, 2004Mardil, Inc.Method and apparatus for external stabilization of the heart
US6718985 *May 25, 2001Apr 13, 2004Edwin J. HlavkaMethod and apparatus for catheter-based annuloplasty using local plications
US6721598 *Aug 31, 2001Apr 13, 2004Pacesetter, Inc.Coronary sinus cardiac lead for stimulating and sensing in the right and left heart and system
US6723784 *Apr 10, 2001Apr 20, 2004Seiko Epson CorporationCoating liquid, and image recording method and recording using same
US6733521 *Apr 11, 2001May 11, 2004Trivascular, Inc.Delivery system and method for endovascular graft
US6881220 *Aug 8, 2003Apr 19, 2005Bard Peripheral Vascular, Inc.Method of recapturing a stent
US6899734 *Mar 23, 2001May 31, 2005Howmedica Osteonics Corp.Modular implant for fusing adjacent bone structure
US7175653 *May 3, 2001Feb 13, 2007Xtent Medical Inc.Selectively expandable and releasable stent
US8172898 *Mar 8, 2010May 8, 2012Cardiac Dimensions, Inc.Device and method for modifying the shape of a body organ
US20020016628 *Oct 1, 2001Feb 7, 2002Langberg Jonathan J.Percutaneous mitral annuloplasty with hemodynamic monitoring
US20020042621 *Jun 22, 2001Apr 11, 2002Liddicoat John R.Automated annular plication for mitral valve repair
US20020042651 *Jun 29, 2001Apr 11, 2002Liddicoat John R.Method and apparatus for performing a procedure on a cardiac valve
US20020049468 *Jun 29, 2001Apr 25, 2002Streeter Richard B.Intravascular filter with debris entrapment mechanism
US20020055774 *Sep 7, 2001May 9, 2002Liddicoat John R.Fixation band for affixing a prosthetic heart valve to tissue
US20020065554 *Oct 25, 2001May 30, 2002Streeter Richard B.Mitral shield
US20030018358 *Jul 3, 2002Jan 23, 2003Vahid SaadatApparatus and methods for treating tissue
US20030040771 *Sep 16, 2002Feb 27, 2003Hideki HyodohMethods for creating woven devices
US20030069636 *Nov 26, 2002Apr 10, 2003Solem Jan OttoMethod for treatment of mitral insufficiency
US20030078465 *Oct 11, 2002Apr 24, 2003Suresh PaiSystems for heart treatment
US20030078654 *Aug 14, 2002Apr 24, 2003Taylor Daniel C.Method and apparatus for improving mitral valve function
US20030083538 *Nov 1, 2001May 1, 2003Cardiac Dimensions, Inc.Focused compression mitral valve device and method
US20030083613 *Dec 6, 2002May 1, 2003Schaer Alan K.Catheter positioning system
US20030088305 *Oct 25, 2002May 8, 2003Cook IncorporatedProstheses for curved lumens
US20030093148 *Oct 9, 2002May 15, 2003Bolling Steven F.Mitral valve annuloplasty ring for molding left ventricle geometry
US20040010305 *May 2, 2003Jan 15, 2004Cardiac Dimensions, Inc.Device and method for modifying the shape of a body organ
US20040019377 *Jan 14, 2003Jan 29, 2004Taylor Daniel C.Method and apparatus for reducing mitral regurgitation
US20040039443 *Dec 24, 2002Feb 26, 2004Solem Jan OttoMethod and device for treatment of mitral insufficiency
US20040073302 *May 27, 2003Apr 15, 2004Jonathan RourkeMethod and apparatus for improving mitral valve function
US20040098116 *Nov 15, 2002May 20, 2004Callas Peter L.Valve annulus constriction apparatus and method
US20040102839 *Jun 26, 2003May 27, 2004Cohn William E.Method and apparatus for improving mitral valve function
US20040102840 *Nov 13, 2003May 27, 2004Solem Jan OttoMethod and device for treatment of mitral insufficiency
US20050004667 *May 10, 2004Jan 6, 2005Cardiac Dimensions, Inc. A Delaware CorporationDevice, system and method to affect the mitral valve annulus of a heart
US20050010240 *May 5, 2004Jan 13, 2005Cardiac Dimensions Inc., A Washington CorporationDevice and method for modifying the shape of a body organ
US20050021121 *Jun 3, 2004Jan 27, 2005Cardiac Dimensions, Inc., A Delaware CorporationAdjustable height focal tissue deflector
US20050027351 *Dec 19, 2003Feb 3, 2005Cardiac Dimensions, Inc. A Washington CorporationMitral valve regurgitation treatment device and method
US20050027353 *Aug 24, 2004Feb 3, 2005Alferness Clifton A.Mitral valve therapy device, system and method
US20050033419 *Aug 24, 2004Feb 10, 2005Alferness Clifton A.Mitral valve therapy device, system and method
US20050038507 *Aug 24, 2004Feb 17, 2005Alferness Clifton A.Mitral valve therapy device, system and method
US20050060030 *Jul 19, 2004Mar 17, 2005Lashinski Randall T.Remotely activated mitral annuloplasty system and methods
US20050065598 *Aug 4, 2004Mar 24, 2005Mathis Mark L.Device, assembly and method for mitral valve repair
US20050096666 *Sep 20, 2004May 5, 2005Gordon Lucas S.Percutaneous mitral valve annuloplasty delivery system
US20050096740 *Nov 1, 2004May 5, 2005Edwards Lifesciences AgTransluminal mitral annuloplasty
US20050107810 *Feb 10, 2004May 19, 2005Guided Delivery Systems, Inc.Devices and methods for heart valve repair
US20060020335 *Sep 23, 2005Jan 26, 2006Leonard KowalskySystem and method to effect the mitral valve annulus of a heart
US20060030882 *Oct 7, 2005Feb 9, 2006Adams John MTransvenous staples, assembly and method for mitral valve repair
US20060041305 *Aug 17, 2005Feb 23, 2006Karl-Lutz LauterjungProsthetic repair of body passages
US20070066879 *Oct 17, 2006Mar 22, 2007Mathis Mark LBody lumen shaping device with cardiac leads
US20080097594 *Dec 21, 2007Apr 24, 2008Cardiac Dimensions, Inc.Device and Method for Modifying the Shape of a Body Organ
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7625399Oct 10, 2006Dec 1, 2009Cook IncorporatedIntralumenally-implantable frames
US7658759Jul 17, 2006Feb 9, 2010Cook IncorporatedIntralumenally implantable frames
US7666224Jul 7, 2005Feb 23, 2010Edwards Lifesciences LlcDevices and methods for heart valve treatment
US7670368Mar 2, 2010Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US7674287Aug 24, 2006Mar 9, 2010Cardiac Dimensions, Inc.Device and method for modifying the shape of a body organ
US7678145Jul 1, 2005Mar 16, 2010Edwards Lifesciences LlcDevices and methods for heart valve treatment
US7682385Jul 3, 2006Mar 23, 2010Boston Scientific CorporationArtificial valve
US7717952Oct 25, 2006May 18, 2010Cook IncorporatedArtificial prostheses with preferred geometries
US7722666Apr 15, 2005May 25, 2010Boston Scientific Scimed, Inc.Valve apparatus, system and method
US7758639Jan 18, 2007Jul 20, 2010Cardiac Dimensions, Inc.Mitral valve device using conditioned shape memory alloy
US7766812Apr 14, 2006Aug 3, 2010Edwards Lifesciences LlcMethods and devices for improving mitral valve function
US7776053Dec 12, 2006Aug 17, 2010Boston Scientific Scimed, Inc.Implantable valve system
US7780627Jul 16, 2007Aug 24, 2010Boston Scientific Scimed, Inc.Valve treatment catheter and methods
US7780722Feb 7, 2005Aug 24, 2010Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US7794496Dec 19, 2003Sep 14, 2010Cardiac Dimensions, Inc.Tissue shaping device with integral connector and crimp
US7799038Jan 20, 2006Sep 21, 2010Boston Scientific Scimed, Inc.Translumenal apparatus, system, and method
US7814635May 12, 2006Oct 19, 2010Cardiac Dimensions, Inc.Method of making a tissue shaping device
US7828841Dec 21, 2007Nov 9, 2010Cardiac Dimensions, Inc.Device and method for modifying the shape of a body organ
US7828842Nov 9, 2010Cardiac Dimensions, Inc.Tissue shaping device
US7828843Aug 24, 2004Nov 9, 2010Cardiac Dimensions, Inc.Mitral valve therapy device, system and method
US7837728Dec 19, 2003Nov 23, 2010Cardiac Dimensions, Inc.Reduced length tissue shaping device
US7837729Sep 20, 2004Nov 23, 2010Cardiac Dimensions, Inc.Percutaneous mitral valve annuloplasty delivery system
US7854755Feb 1, 2005Dec 21, 2010Boston Scientific Scimed, Inc.Vascular catheter, system, and method
US7854761Dec 19, 2003Dec 21, 2010Boston Scientific Scimed, Inc.Methods for venous valve replacement with a catheter
US7857846May 2, 2003Dec 28, 2010Cardiac Dimensions, Inc.Device and method for modifying the shape of a body organ
US7878966Feb 4, 2005Feb 1, 2011Boston Scientific Scimed, Inc.Ventricular assist and support device
US7883539Apr 23, 2002Feb 8, 2011Edwards Lifesciences LlcHeart wall tension reduction apparatus and method
US7887582May 5, 2004Feb 15, 2011Cardiac Dimensions, Inc.Device and method for modifying the shape of a body organ
US7892276Dec 21, 2007Feb 22, 2011Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US7951189Jul 27, 2009May 31, 2011Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US8250960Aug 29, 2011Aug 28, 2012Cardiac Dimensions, Inc.Catheter cutting tool
US8974525Oct 19, 2010Mar 10, 2015Cardiac Dimensions Pty. Ltd.Tissue shaping device
US20040220657 *Dec 19, 2003Nov 4, 2004Cardiac Dimensions, Inc., A Washington CorporationTissue shaping device with conformable anchors
US20050187619 *Nov 19, 2004Aug 25, 2005Mathis Mark L.Body lumen device anchor, device and assembly
Classifications
U.S. Classification623/2.11, 623/2.37
International ClassificationA61B17/00, A61F2/24, A61N1/05
Cooperative ClassificationA61N1/057, A61F2/2451, A61B2017/00243, A61N2001/0585
European ClassificationA61N1/05N4, A61F2/24R4
Legal Events
DateCodeEventDescription
May 18, 2005ASAssignment
Owner name: CARDIAC DIMENSIONS, INC., WASHINGTON
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MATHIS, MARK L.;NIEMINEN, GREGORY D.;REUTER, DAVID G.;REEL/FRAME:016587/0570
Effective date: 20020130