US20060030885A1 - Apparatuses and methods for heart valve repair - Google Patents

Abstract

A medical device for treating a heart having a faulty heart valve is disclosed. The medical device comprises a ligature including a first anchoring member and a second anchoring member is used. The ligature is percutaneously deployable into a patient with a faulty heart valve wherein the first anchoring member to anchor to a first tissue area of the heart and the second anchoring member to anchor to a second tissue area of the heart.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention involves a medical device that is used for treating a defective heart valve.
• 2. Discussion of Related Art
• FIG. 1A illustrates aheart10. There are four valves in theheart10 that serve to direct the flow of blood through the two sides of theheart10 in a forward direction. The four valves are amitral valve20, anaortic valve18, atricuspid valve60, and apulmonary valve62 as illustrated inFIG. 1A. Themitral valve20 is located between theleft atrium12 and theleft ventricle14. Theaortic valve18 is located between theleft ventricle14 and theaorta16. These two valves direct oxygenated blood coming from the lungs, through the left side of the heart, into theaorta16 for distribution to the body. Thetricuspid valve60 is located between theright atrium22 and theright ventricle24. Thepulmonary valve62 is located between theright ventricle24 and thepulmonary artery26. These two valves direct de-oxygenated blood coming from the body, through the right side of the heart, into thepulmonary artery26 for distribution to the lungs, where it again becomes re-oxygenated and distributed to themitral valve20 and theaortic valve18. All of the heart valves are complex structures. Each valve consists of moveable “leaflets” that are designed to open and close. The mitral valve has two leaflets and the tricuspid valve has three. The aortic and pulmonary valves have leaflets that are more aptly termed “cusps” and are shaped somewhat like a half-moon. The aortic and pulmonary valves each have three cusps.
• Blood flows into theleft ventricle14 through themitral valve20 opens during diastole. Once the left ventricular cavity has filled, theleft ventricle14 contracts during systole. Themitral valve20 closes (the leaflets of themitral valve20 re-approximate) while theaortic valve18 opens during systole allowing the oxygenated blood to be ejected from theleft ventricle14 into theaorta16. A normal mitral valve allows blood to flow into the left ventricle and does not allow leaking or regurgitating back into the left atrium and then into the lungs. The aortic valve allows blood to flow into the aorta and does not allow leaking (or regurgitating) back into the left ventricle. Thetricuspid valve60 functions similarly to the mitral valve to allow deoxygenated blood to flow into theright ventricle24. Thepulmonary valve62 functions in the same manner as theaortic valve18 in response to relaxation and contraction of theright ventricle24 in moving de-oxygenated blood into the pulmonary artery and thence to the lungs for re-oxygenation.
• With relaxation and expansion of the ventricles (diastole), the mitral and tricuspid valves open, while the aortic and pulmonary valves close. When the ventricles contract (systole), the mitral and tricuspid valves close and the aortic and pulmonary valves open. In this manner, blood is propelled through both sides of the heart.
• The anatomy of the heart and the structure and terminology of heart valves are described and illustrated in detail in numerous reference works on anatomy and cardiac surgery, including standard texts such as Surgery of the Chest (Sabiston and Spencer, eds., Saunders Publ., Philadelphia) and Cardiac Surgery by Kirklin and Barrett-Boyes.
• Regurgitation is a condition when leaflets of a heart valve do not completely close causing backflow of blood. For instance, in a condition typically called mitral valve prolapse, the leaflets of the mitral valve do not close properly and thus, there is backflow, or regurgitation, of blood into the left atrium and then into lungs. The heart then has to work harder to pump enough blood for the body, which can lead to heart damage. Regurgitation is common, and is occurring in about 7% of the population. Mitral valve regurgitation is caused by a number of conditions, including genetic defects, infections, coronary artery disease (CAD), myocardial infarction (MI) or congestive heart failure (CHF). Most cases are mild and if the symptoms are bothersome, they can usually be controlled with drugs.
• In more serious cases, the faulty or defective valve can be repaired with a surgical procedure such as an annuloplasty. As illustrated inFIG. 1B, anannuloplasty30 is a surgical procedure in which asynthetic ring32 is placed around the valve rim (annulus)34.Sutures38 are put into thevalve annulus34 and thesynthetic ring32. This causes proper closing by shrinking the size of the valve opening36.FIG. 1C illustrates another surgical procedure in which a heart valve such as themitral valve20 is repaired by reconstruction. First, at step A, a section P2 from the posterior leaflet40 of themitral valve20 is excised. Then, sequentially at steps B, C, D, and E, sections P1 and P3 of the posterior leaflet40 are sutured together. The reconstruction shrinks the size of the valve opening36. In some instances, a faulty or defective valve must be surgically replaced with a new valve. Examples of new valves include homograft valves (valves harvested from human cadavers), artificial mitral valves, and mechanical valves.
• All of the procedures above are typically major surgical procedures that require the opening of the chest by sternotomy or at best through small incisions in the chest wall, heart lung bypass and stopping the heart beat. These procedures are extremely invasive subjecting patients to a lot of pain and discomfort and these procedures require long recovery time and hospitalization time. In some instances, some patients may not tolerate surgery, for example, due to them having congestive heart failures. Thus, having alternative procedures as options to surgery is helpful.
SUMMARY OF THE INVENTION
• The present invention discloses apparatuses and methods for treating a defective heart valve.
• In one exemplary embodiment of the present invention, a medical device comprises a ligature, including a first anchoring member and a second anchoring member. The ligature is used to treat a hear having a faulty heart valve (e.g., a faulty mitral valve). The ligature is percutaneously deployable into a patient with a faulty heart valve, wherein the first anchoring member anchors to a first tissue area of the faulty heart valve and the second anchoring member anchors to a second tissue area of the faulty heart valve. The ligature constricts or reduces the size of the faulty heart valve.
• In another exemplary embodiment of the present invention, a medical device comprises a delivery shaft having a delivery lumen, a proximal end, and a distal end. A first deployment shaft, extending from the proximal end to the distal end, is disposed within the delivery lumen. A second deployment shaft, extending from the proximal end to the distal end, is disposed within the delivery lumen. A ligature is releasably coupled to the delivery shaft. The ligature includes a first anchoring member and a second anchoring member. The delivery shaft deploys the ligature into a patient, wherein the first deployment shaft deploys the first anchoring member to a first tissue area of the patient, and the second deployment shaft deploys the second anchoring member to a second tissue area of the patient.
• In another exemplary embodiment of the present invention, a method of constricting a heart valve of a patient comprises providing a medical device comprising a delivery shaft having a delivery lumen, a proximal end, and a distal end. The delivery shaft comprises a first deployment shaft and a second deployment shaft disposed within the delivery lumen. A ligature including a first anchoring member and a second anchoring member is releasably coupled to the delivery shaft wherein the first anchoring member is releasably coupled to the first deployment shaft and the second anchoring member is releasably coupled to the second deployment shaft. The method further comprises deploying the ligature into the patient wherein the first deployment shaft deploys the first anchoring member to a first tissue area around the heart valve, and the second deployment shaft deploys the second anchoring member to a second tissue area of the heart valve. Once deployed, the ligature anchors the first anchoring member to the first tissue area and the second anchoring member to the second tissue area.
• In another exemplary embodiment of the present invention, a method of constricting a heart valve of a patient comprises providing a medical device comprising a delivery shaft having a delivery lumen, a proximal end, and a distal end. The delivery shaft comprises a first deployment shaft and a second deployment shaft disposed within the delivery lumen. The method further comprises coupling a first ligature to the delivery shaft and deploying the first ligature to a heart valve area of the patient and coupling a second ligature to the delivery shaft and deploying the second ligature to the heart valve area of the patient. Each of the ligatures includes a first anchoring member and a second anchoring member wherein the first anchoring member is releasably coupled to the first deployment shaft and the second anchoring member is releasably coupled to the second deployment shaft. The first deployment shaft deploys the first anchoring member to anchor the first anchoring member to the heart valve area to constrict the heart valve. The second deployment shaft deploys the second anchoring member to anchor the second anchoring member to the heart valve area to constrict the heart valve.
BRIEF DESCRIPTION OF THE DRAWINGS
• The present invention is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:
• FIG. 1A is an illustration of a heart;
• FIG. 1B is an illustration of an annuloplasty procedure to constrict a defective valve;
• FIG. 1C is an illustration of a reconstruction procedure to reduce the size of a defective valve;
• FIG. 2A is an illustration of an exemplary embodiment of a ligature in accordance with the present invention;
• FIG. 2B is an illustration of another exemplary embodiment of a ligature in accordance with the present invention;
• FIG. 3 is an illustration of another exemplary embodiment of a ligature in accordance with the present invention;
• FIG. 4 is an illustration of an exemplary embodiment of two ligatures being placed across a mitral valve in a parallel pattern to constrict the mitral valve in accordance with the present invention;
• FIG. 5 is an illustration of another exemplary embodiment of two ligatures being placed across a mitral valve in an intersecting pattern to constrict the mitral valve in accordance with the present invention;
• FIG. 6 is an illustration of an exemplary embodiment of a medical device that includes a delivery device which is used to percutaneously deploy a ligature into a patient to constrict a heart valve;
• FIG. 7 is an illustration of a distal end of the medical device shown inFIG. 6 having a ligature disposed therein;
• FIG. 8 is an illustration of a mid-section of the medical device shown inFIG. 6;
• FIGS. 9-10 are illustrations of a perspective view of the medical device shown inFIG. 6 wherein a ligature is being deployed from the delivery shaft;
• FIGS. 11A-11B illustrate another exemplary embodiment of a medical device that includes a delivery device which is used to percutaneously deploy a ligature into a patient to constrict a heart valve;
• FIG. 12A is an illustration of an exemplary embodiment of a deployment shaft that can be used to deploy a ligature made in accordance with the present invention;
• FIG. 12B is an illustration of an exemplary embodiment of the deployment shaft shown inFIG. 12A being disposed within a deployment lumen of a delivery device;
• FIG. 12C is an illustration of an exemplary embodiment of a ligature with helix ends as anchoring members made in accordance with the present invention;
• FIG. 12D is an illustration of an exemplary embodiment of the ligature shown inFIG. 12C being disposed within the deployment shaft shown inFIG. 12B;
• FIG. 12E is an illustration of an exemplary embodiment of the ligature shown inFIG. 12C being disposed within the deployment shaft shown inFIG. 12B which is disposed within a deployment lumen of a delivery device;
• FIGS. 12F-12G are illustrations of a distal end of the medical device shown inFIG. 6 with a ligature having helix ends as anchoring members;
• FIGS. 13A-13H are illustrations of an exemplary embodiment of a method to deploy a ligature or ligatures in accordance with the present invention;
• FIG. 14A is an illustration of an exemplary embodiment where a medical device made in accordance with the present invention can be inserted percutaneously into a patient to deploy a ligature to a heart valve area;
• FIG. 14B is an illustration of another exemplary embodiment where a medical device made in accordance with the present invention can be inserted percutaneously into a patient to deploy a ligature to a heart valve area;
• FIG. 14C is an illustration of an exemplary embodiment where a medical device made in accordance with the present invention can be inserted percutaneously into a patient to deploy a ligature to a ventricle area;
• FIGS. 15A-15D are illustrations of an exemplary embodiment where a medical device made in accordance with the present invention can be inserted percutaneously into a coronary sinus; and
• FIG. 16 is an illustration of an exemplary method of treating heart valve using medical devices made in according with the present invention.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
• The present invention pertains to novel medical devices and methods of using these medical devices to treat defective or faulty heart valves. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be evident, however, to one skilled in the art, that the present invention may be practiced without these specific details. In other instances, specific apparatus structures and methods have not been described so as not to obscure the present invention. The following description and drawings are illustrative of the invention and are not to be construed as limiting the invention.
• FIG. 2A illustrates an exemplary embodiment of a medical device that comprises aligature100. Theligature100 can be a strap, string, cord, wire, bond, thread, suture, or other connector. Theligature100 includes afirst anchoring member102A and asecond anchoring member102B. Theligature100 serves to link together thefirst anchoring member102A and thesecond anchoring member102B. Theligature100 can be percutaneously deployed into a patient with a faulty heart valve. By percutaneous deployment, theligature100 is deployed through blood vessels, veins, or arteries into a patient. In one embodiment, theligature100 is deployed through the blood vessels, veins, or arteries and into the heart area of a patient. Thefirst anchoring member102A and thesecond anchoring member102B are then attached or anchored to a cardiac tissue (e.g., tissue around the heart valve). In one embodiment, thefirst anchoring member102A and thesecond anchoring member102B are not attached or anchored to a blood vessel, vein, or artery, and only attached or anchored to a cardiac tissue.
• A faulty heart valve includes a heart valve that will not properly close causing backflow or regurgitation of blood. Such a faulty heart valve can be seen in a patient with a condition called regurgitation. In treating the faulty heart valve, thefirst anchoring member102A anchors to a first tissue area of the faulty heart valve and thesecond anchoring member102B anchors to a second tissue area of the faulty heart valve. Theligature100 has a length that is sufficient to constrict or reduce the size of the heart valve once the anchoringmembers102A and102B are anchored into the tissue areas of the heart valve. Examples of a heart valve that can be treated with theligature100 include a mitral valve, an aortic valve, a tricuspid valve, and a pulmonary valve.
• Although theligature100 is discussed in relation to treating a faulty heart valve, theligature100 may be used to treat other areas of a patient. For example, theligature100 can be used in ventricular remodeling to constrict, reshape, or reduce, the size of a left ventricle that has been enlarged due to some heart conditions. Alternatively, theligature100 can be used to close a vein or an artery of a patient.
• Theligature100 can be flexible or rigid. In one embodiment, theligature100 is made out of an elastic/resilient material, an elastomeric material, or a superelastic material. In one embodiment, theligature100 is made out of a superelastic nickel titanium, Nitinol, or stainless steel. In another embodiment, theligature100 is made out of a suture material suitable for suturing a tissue of a patient. Theligature100 can be made out of existing suture materials such as polymers like PTFE, Polyethylene or similar polymers, and resorbable polymers. Theligature100 can also be made out of an allograph material such as treated porcine, bovine or human tissue.
• In one embodiment, a delivery device, described below, is used to deploy theligature100 to a heart to treat a faulty heart valve. Such a delivery device is able to attach the two anchoringmembers102A and102B of theligature100 to two different attachment sites (e.g., cardiac tissues or tissue areas within or proximate the heart). The anchoringmember102A is attached to one attachment site and the anchoringmember102B is attached to the other attachment site. During the attachment step, theligature100 may be stretched so as to reach both attachment sites. In some cases, theligature100 does not need to be stretchable for theanchoring members102A and102B of theligature100 to anchor into the two different attachment sites. After the attachment step, theligature100 is able to constrict or reduce the size of the heart valve. In the embodiment where theligature100 is flexible, theligature100 is stretched during the attachment step and is returned to its unstretched length after the attachment step thus, constricting (or reducing) the size of the heart valve. In the embodiment where theligature100 is rigid, the length of theligature100 is smaller than the size or the diameter of the heart valve thus, after the attachment step, the valve can be constricted or reduced.
• In one embodiment,multiple ligatures100 are placed across the faulty heart valve annulus to reshape or reduce the circumference or perimeter of the heart valve annulus. Theligature100 may have cross section size that is sufficiently small to not significantly impede the flow of blood (or other fluid) through the heart valve or produce thrombus. Theligature100 may be of a dimension that is similar to surgical sutures known in the field. Theligature100 may have a cross section size between 0.001 mm and 5.0 mm. Theligature100 may have a length between 10 mm and 600 mm. Theligature100 may have an unstretched length between 10 mm and 600 mm that can be stretched to an appropriate length for deployment purposes and that can be returned to the unstretched length after the deployment of theligature100.
• In some cases, theligatures100 are placed across a faulty heart valve and left in place for a specific period of time to improve the heart valve function. In other cases, theligatures100 aid in positive remodeling of the left ventricle by constricting (or reducing) the size of the faulty heart valve annulus so as to relieve the left ventricle from working extra hard to pump blood out of the left ventricle to other areas of the body. After this remodeling/recovery time a removal system could be employed at a later date to excise theligatures100.
• In one embodiment, theligature100 has two ends wherein thefirst anchoring member102A is attached to one end of theligature100 and thesecond anchoring member102B is attached to the other end of theligature100. The anchoringmembers102A and102B are elements that can enter a tissue of a patient body (e.g., a cardiac tissue) and be anchored and retained therein.FIG. 2A illustrates an exemplary configuration of theanchoring members102A and102B, which are referred to as “barbed end” configurations. The anchoringmembers102A and102B havepointy ends106A and106B. The anchoringmembers102A and102B may also have a plurality ofprongs108A and108B. The pointy ends106A and106B allow theanchoring members102A and102B to easily pierce through a tissue wall to begin the anchoring process. Theprongs108A and108B prevent theanchoring members102A and102B from being detached or released from the tissue thus anchoring theanchoring members102A and102B to the tissue wall. Each of theanchoring members102A and102B has apredetermined length126A andlength126B, which is dependent upon on the tissue depth that the each of theanchoring members102A and102B needs to pierce through to be anchored to the tissue.
• The anchoring members of theligature100 need not have the configurations shown inFIG. 2A. Another possible configurations includes a hook-end configuration as shown inFIG. 2B. Theligature100 shown inFIG. 2B includes a first hook-end anchoring member103A and a second hook-end anchoring member103B. The first hook-end anchoring member103A and the second hook-end anchoring member103B can anchor the ends of theligature100 to a cardiac tissue similar to theanchoring members102A and102B shown inFIG. 2A.
• In one embodiment, the anchoring members have a helix end configuration as illustrated inFIG. 3. In this embodiment, theligature100 includes helix ends104A and104B. The helix ends104A and104B have ends105A and105B that may be pointy, sharp, or blunt depending on the type of tissue that the helix ends are to be anchored to. The helix ends104A and104B may be continuous helixes made of shape memory material that can maintains the helix ends104A and104B in their helical configuration. The helix ends104A and104B enter the tissue by threading and rotating through the tissue similar to action of a screw. Each of theanchoring members104A and104B has apredetermined length127A andlength127B, which is dependent upon on the tissue depth that the each of the helix ends104A and104B needs to pierce through to be anchored to the tissue. In another embodiment, theligature100 includes double helix ends (not shown) to increase retentive or anchoring strength.
• The anchoring members (e.g., the anchoringmembers102A,102B,103A,103B,104A, and104B) of theligature100 can be made out of metals, plastic, or any other hard materials that are biocompatible or implantable and are suitable for use in a patient's body. The anchoring members can also be made out of a semi stiff implantable material. The anchoring members can be made out of stainless steel, titanium, titanium alloy, nickel, nickel titanium alloy, chroma alloy or other suitable metal alloys. The anchoring members can also be made out of polymers, high density polyethylene (HDPE), polyglycolic acid, and polyglycolid hydroxyacetic acid. In one embodiment, the anchoring members or at least portions of the anchoring members are coated with a biocompatible lubricious material that provides for easier delivery and entrance into the tissue.
• FIG. 4 illustrates an exemplary embodiment where two of theligatures100 are placed across a heart valve such as a mitral valve. InFIG. 4, aheart202 includes amitral valve204, amitral valve annulus206, a leftfibrous ring220, a rightfibrous trigone200 and aleft fibrous trigone210. Themitral valve204 may be a faulty mitral valve such as those seen in patients having regurgitation. In one embodiment, the ligatures100 (each including anchoringmembers102A and102B) are placed across themitral valve204 in a semi-parallel pattern. In one embodiment, an anchoringmember102A of aligature100 is placed in theleft fibrous trigone210 and an anchoringmember102B is placed in a location on the opposite side of themitral valve annulus206 in the leftfibrous ring220. Another anchoringmember102A of anotherligature100 is placed in the rightfibrous trigone200 and the other end of another ligature is placed in a location on the opposite side of themitral valve annulus206 in the leftfibrous ring220. If necessary,multiple ligatures100 may be placed across themitral valve annulus206 in a semi-parallel pattern.
• FIG. 5 illustrates another exemplary embodiment where two of theligatures100 are placed across a heart valve such as a mitral valve. The placement of theligatures100 inFIG. 5 is similar to the placement shown inFIG. 4 except that theligatures100 intersect or cross each other. InFIG. 5, aheart202 includes amitral valve204, amitral valve annulus206, a leftfibrous ring220, a rightfibrous trigone200 and aleft fibrous trigone210. In one embodiment, the ligatures100 (each including anchoringmembers102A and102B) are placed across themitral valve204 in an intersecting or cross pattern. In one embodiment, an anchoringmember102A of aligature100 is placed in theleft fibrous trigone210 and an anchoringmember102B is placed in a location on the opposite side of themitral valve annulus206 in the leftfibrous ring220. Another anchoringmember102A of anotherligature100 is placed in the rightfibrous trigone200 and the other end of thisligature100 is placed in a location on the opposite side of themitral valve annulus206 in the leftfibrous ring220. If necessary,multiple ligatures100 may be placed across themitral valve annulus206 in the intersecting or cross pattern.
• It is to be appreciated that the semi parallel and the intersecting patterns can be combined together for the placements of theligatures100 if necessary. Additionally, the anchoring members of the ligatures shown inFIGS. 4 and 5 can have barbed end configurations as those shown for theanchoring members102A or102A, helix ends104A or104B, as those shown inFIG. 3 or hook ends103A and103B as those shown inFIG. 2B, or other types of ends that will anchor the ends of theligature100 to a tissue or a cardiac tissue. Also, aligature100 may include more than one anchoring member at each end of theligature100.
• FIG. 6 illustrates a perspective view of one exemplary embodiment of amedical device301 that includes aligature100 which can be used to percutaneously deploy aligature100 to a heart to treat a faulty heart valve.FIG. 7 illustrates a cross section “A” of the distal end324 of themedical device301.FIG. 8 illustrates a cross section “B” of the mid-section of themedical device301.
• In one embodiment, themedical device301 comprises adelivery shaft300 having a delivery lumen305 (FIGS. 7-8), a proximal end322, and a distal end324. In one embodiment, thedelivery shaft300 is a catheter, which is sized and shaped as generally known in the art to travel within and along the vascular tree to the heart of a patient. Afirst deployment shaft310A and asecond deployment shaft310B are disposed within thedelivery lumen305 and extend from the distal end324 to the proximal end322. Aligature100 is releasably coupled to thedelivery shaft300 at the distal end324 such that theligature100 is coupled to thedelivery shaft300 for deployment, and after deployment, theligature100 is released from thedelivery shaft300. Theligature100 includes afirst anchoring member102A and asecond anchoring member102B and theligature100 links them as previously described. Themedical device301 can deploy theligature100 into a patient wherein thefirst deployment shaft310A deploys thefirst anchoring member102A to a first tissue area of the patient (e.g., a cardiac tissue, a tissue proximate a mitral valve, or a portion of the mitral valve) and thesecond deployment shaft310B deploys thesecond anchoring member102B to a second tissue area of the patient (e.g., another cardiac tissue, another tissue proximate a mitral valve, or another portion of the mitral valve).
• In one embodiment, theligature100 is contained in the distal end324 of thedelivery shaft300 near the cross section “A.” Thedelivery lumen305 may be a dumbbell shapedlumen305. The dumb bell shapedlumen305 provides a compartment in the distal end of thedelivery shaft300 where theligature100 can reside undisturbed as themedical device301 is advanced to an area of the heart to be treated.
• In one embodiment, theligature100 is housed inside thedelivery lumen305 on the distal end324. The anchoringmember102A of theligature100 is mounted on the distal end of thedeployment shaft310A; and, the anchoringmember102B is mounted on the distal end of thedeployment shaft310B. In one embodiment, thedeployment shaft310A is housed in itsown deployment lumen306 and the deployment shaft3101B is housed in itsown deployment lumen308. Thedeployment lumens306 and308 may combine together to form the dumbbell shape lumen305 or may be two separate lumens comprised within thedelivery shaft300. Thedelivery lumen305 does not need to (but may) maintain its dumb bell shape for the entire length of thedelivery shaft300 or may only have the dumb bell shape at the distal end324 of thedelivery shaft300. Thedelivery shaft300 may include additional lumens such as additional lumens for the delivery of additional ligatures or for sensing endoscopy or to allow a pull wire to be used to deflect the distal end324 (in order to control the positions where the anchoring members are anchored).
• In one embodiment, thedelivery shaft300 is further coupled to ahandle member340, which is used in deploying the ligature orligatures100 as shown inFIG. 6. Thehandle member340 includes adeployment mechanism350A and adeployment mechanism350B, which can advance or retract thedeployment shafts310A and3101B, respectively, to deploy theligature100. In one embodiment, the proximal end of thedeployment shaft310A is connected to thedeployment mechanism350A. The proximal end of the deployment shaft3101B is connected to thedeployment mechanism350B.
• In one embodiment, thedelivery shaft300 also includes aguide wire lumen320 as shown inFIGS. 7-8. Theguide wire lumen320 extends from the distal end324 of thedelivery shaft300 to the proximal end322 of thedelivery shaft300, through thehandle member340, and is connected to aguide wire port360 in the proximal end of thehandle member340. Theguide wire lumen320 is sufficiently sized and shaped to allow for the insertion of a guide wire (not shown). The guide wire may be disposed through theguide wire lumen320 to guide or maneuver thedelivery shaft300 from the entrance of the patient's body through the body of the patient to reach the area of the heart where theligature100 will be deployed, e.g., a mitral valve. In one embodiment, theguide wire port360 is used to control the advancement, movement, or steering of the guide wire through the patient's body.
• In one embodiment, thedelivery shaft300 may include reinforcement member such as a plurality of strands disposed in braided pattern, a plurality of fibers kitted together, or a coiled wire (not shown). In another embodiment, thedelivery shaft300 may comprise other lumens or supporting member (not shown) that can be used to steer or aim the distal end324 of themedical device301 in a desired direction. These supporting members may be of a pre-shaped nature curving thedelivery shaft300 as the supporting members are advanced within a lumen to the distal end324 of thedelivery shaft300. One or more of these steering lumen and supporting member may be present in thedelivery shaft300.
• In another embodiment, a supporting member may consist of a member (not shown) that is coupled to the distal end324 of a steering lumen included within thedelivery shaft300. The steering lumen can be theguidewire lumen320 shown inFIGS. 7-8. The supporting member may extend from the distal end324 to the proximal end322 of thedelivery shaft300. In one embodiment, pulling on this supporting member at the proximal end322 causes the distal end324 of the delivery shaft to become curved. In another embodiment, the steering lumen is pressurized causing the distal end324 of the delivery system to bend in a desired direction.
• In one embodiment, theguide wire lumen320 may only be present in the distal end322 of thedelivery shaft300 as in common rapid exchange catheter design known in the art. A common rapid exchange catheter is well known in the art. In another embodiment, theguide wire lumen320 may absent from thedelivery shaft300 and may be replaced by one or more tendons to produce a bendabletip delivery shaft300.
• Thedelivery shaft300 may be made out of numerous different types of materials. In one embodiment, thedelivery shaft300 is made out of materials that are suitable for inserting into a patient's body. For example, thedelivery shaft300 may be made out of materials suitable for making a catheter. Thedelivery shaft300 may be made out of polyether block amid (PEBA), polyethylene (PE), polyproplylene (PP), polyvinylchloride (PVC), polytetrafluoroethylene (PTFE), or polyurethane, or other types of biocompatible material.
• In one embodiment, thedelivery shaft300 comprises at least one radiopaque marker to aid the operator (e.g., a physician) in the monitoring, placing, or inserting of thedelivery shaft300 into a patient. The radiopaque marker can be a band of radiopaque material disposed proximate the distal end324 of thedelivery shaft300. The radiopaque material aids the operator in determining the location of the distal end324 of thedelivery shaft300. Examples of a radiopaque material include gold, platinum, tungsten, iron, silver, and thermoplastic material loaded with a radiopaque filler such as barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten power, and depleted uranium, etc. In another embodiment, thedelivery shaft300 comprises at least one Magnetic Resonance Imaging (MRI) marker to aid the operator in the monitoring, placing, or inserting of thedelivery shaft300 into a patient. An example of an MRI marker materials include platinum, tungsten, iridium, barium sulfate, plastic, or other particles suitable for a MRI process. Alternatively, the MRI marker can be an active component such as a small circuit that can generate a radio frequency (RF) that an MRI scanner can detect.
• FIG. 9 illustrates a perspective view of themedical device301 wherein thedelivery shaft300 is deploying theligature100 that is releasably coupled to thedelivery shaft300. In one embodiment, themedical device301 is used to deploy theligature100 to place theligature100 across the mitral valve as illustrated inFIG. 4-5. Themedical device301 can be used to deploy theligature100 to other area of the heart, for example, within a coronary sinus (seeFIG. 15A) or over the left ventricle of the heart (seeFIGS. 14B and 14C).
• In one embodiment, advancing thedeployment shaft310A advances the anchoringmember102A of theligature100 out of thedelivery shaft300 as illustrated inFIG. 9. As thedeployment shaft310A is advanced, the anchoringmember102A is advanced from thelumen305 at the distal end324 of thedelivery shaft300 to atissue area326. Once the anchoringmember102A is anchored to thetissue area326, thedeployment shaft310A can be retracted into thedelivery shaft300 leaving the anchoringmember102A embedded in thetissue area326. In one embodiment, thedeployment shaft310A is retracted as illustrated inFIG. 10 wherein the anchoringmember102A is left attached or anchored to thetissue area326. This process can be repeated for the anchoringmember102B of theligature100. Thedeployment shaft310B is advanced out of thedelivery shaft300 thus advancing the anchoringmember102B. In one embodiment, the anchoringmember102B is anchored to atissue area328 which can be substantially opposite thetissue area326 where the anchoringmember102A is anchored. Once the anchoringmember102B is anchored into thetissue area328, thedeployment shaft310B is retracted into thedelivery shaft300.
• In the embodiment where theligature100 is flexible, once both of theanchoring members102A and102B of theligature100 are anchored, theligature100 is allowed to return to its original length (unstretched length) or its original shape, thus, bringing thetissue areas326 and328 closer to each other. When thetissue areas326 and328 are brought closer to each other, the heart structure that theligature100 is placed across, e.g., the mitral valve, is narrowed, reduced, or constricted. In the embodiment where theligature100 is made of a rigid material, once the anchoringmembers102A and102B of theligature100 are anchored, theligature100 pull thetissue areas326 and328 are closer to each other. Again, when thetissue areas326 and328 are brought closer to each other, the heart structure that theligature100 is placed across, e.g., the mitral valve, is narrowed, reduced, or constricted.
• Themedical devices301 shown inFIGS. 6-8 and9-10 include theligature100 that has barbed end configurations for theanchoring members102A and102B. It is to be appreciated that theanchoring members102A and102B may have other configurations, for examples, helixes, or hooks as shown inFIGS. 2B and 3.
• FIGS. 11A-11B illustrate an exemplarymedical device302. Themedical device302 is similar to themedical device301 except that thedevice302 is more preferred for delivering aligature100 that has helix ends as the anchoring members. As illustrated inFIGS. 11A-11B, themedical device302 comprises adelivery shaft303 having adelivery lumen318, aproximal end332, and adistal end334. In one embodiment, thedelivery shaft303 is a catheter, which is sized and shaped as generally known in the art to travel within and along the vascular tree to the heart of a patient. In another embodiment, thedelivery shaft303 is the same as thedelivery shaft300.
• In one embodiment, afirst deployment shaft307 and asecond deployment shaft309 are disposed within thedelivery lumen318 and extended from thedistal end334 to theproximal end332. Aligature100 is releasably coupled to thedelivery shaft303 at thedistal end334 such that theligature100 is coupled to thedelivery shaft303 for deployment, and after deployment, theligature100 is released from thedelivery shaft303. Theligature100 includes afirst anchoring member104A and asecond anchoring member104B which are of helix ends. Themedical device302 can deploy theligature100 into a patient wherein thefirst deployment shaft307 deploys thefirst anchoring member104A to a first tissue area of the patient (e.g., a cardiac tissue, a tissue proximate a mitral valve, or a portion of the mitral valve) and thesecond deployment shaft309 deploys thesecond anchoring member104B to a second tissue area of the patient (e.g., a cardiac tissue, a tissue proximate a mitral valve, or a portion of the mitral valve).
• In one embodiment, theligature100 is contained in thedistal end334 of thedelivery shaft303. Thedelivery lumen318 may be a dumbbell shapedlumen318. The dumb bell shapedlumen318 provides a compartment in the distal end of thedelivery shaft303 where theligature100 can reside undisturbed as themedical device302 is advanced through the patient's vasculature to an area of the heart to be treated.
• In one embodiment, theligature100 is housed inside thedelivery lumen318 on thedistal end334. The anchoringmember104A of theligature100 is mounted on the distal end of thedeployment shaft307; and, the anchoringmember104B is mounted on the distal end of thedeployment shaft309. In one embodiment, thedeployment shaft307 is housed in itsown deployment tube336 and thedeployment shaft308 is housed in itsown deployment tube338 as illustrated inFIG. 1I B. Thedeployment tubes336 and338 may combine together to form the dumbbell shape lumen318 or may be two separate tubes disposed within thedelivery shaft303. Thedelivery lumen318 does not need (but may) maintain its dumb bell shape for the entire length of thedelivery shaft303 or may only have the dumb bell shape at thedistal end334 of thedelivery shaft303.
• In one embodiment, thedelivery shaft303 is further coupled to ahandle member304, which is used to deploy the ligature or ligatures100. Thehandle member304 includes adeployment mechanism350A and adeployment mechanism350B, which can advance or retract thedeployment shafts307 and309, respectively, to bring theligature100 closer to the anchoring sites. In one embodiment, at least a section near the proximal end of thedeployment shaft307 is connected to thedeployment mechanism350A. A section near the proximal end of thedeployment shaft309 is connected to thedeployment mechanism350B. In one embodiment, as thedeployment shafts309 and309 are advanced or retraced, the anchoringmembers104A and104B of theligature100 are advanced or retracted.
• Thehandle member304 also includes arotating mechanism314 and arotating mechanism316, which can rotate thedeployment shafts307 and309 as thedeployment shafts307 and309 are advanced or retracted. In one embodiment, the proximal end of thedeployment shaft307 is connected to therotating mechanism314. The proximal end of thedeployment shaft309 is connected to therotating mechanism316. In one embodiment, rotating therotating mechanism314 rotates thedeployment shaft307 thus rotating the anchoringmember104A. Similarly, rotating therotating mechanism316 rotates thedeployment shaft309 thus rotating the anchoringmember104B.
• In one embodiment, thedeployment tubes336 and338 are connected to thedeployment mechanisms350A and350B, respectively. In this embodiment, thedeployment tubes336 and338 are advanced or retracted by thedeployment mechanisms350A and350B. As thedeployment tube336 and338 are advanced or retracted, thedeployment shafts307 and309 are also advanced or retracted. Thus, in this case, to deploy theanchoring members104A and104B, thedeployment mechanisms350A and350B advance thedeployment tubes336 and338, respectively. Thedeployment tubes336 and338 may be advanced completely out of thedelivery shaft303 or may only be partially advanced. Then, thedeployment shafts307 and309 are then rotated by the rotatingmechanisms314 and316, respectively to deploy theanchoring members104A and104B.
• In one embodiment, thedelivery shaft303 also includes aguide wire lumen312 as illustrated inFIGS. 11A-11B. Theguide wire lumen312 extends from thedistal end334 of thedelivery shaft303 to theproximal end332 of thedelivery shaft303, and through thehandle member304 and is connected to aguide wire port330 located at the proximal end of thehandle member304. The guide wire lumen is sufficiently sized and shaped to allow for the insertion of a guide wire (not shown). The guide wire may be disposed through theguide wire lumen312 to guide or maneuver thedelivery shaft303 through the body of the patient to reach the area of the heart where theligature100 is to be deployed, e.g., a mitral valve. In one embodiment, the guide wire port is used to control the advancement, movement, or steering of the guide wire through the patient's body.
• In one embodiment, thedelivery shaft303 may include reinforcement member similar to thedelivery shaft300 described above. In another embodiment, thedelivery shaft303 may comprise other lumens or supporting member that can be used to steer or aim thedistal end334 of themedical device302 in a desired direction. These supporting members may be of a pre-shape nature curving thedelivery shaft303 as the supporting members are advanced within a lumen to thedistal end334 of thedelivery shaft303. One or more of these steering lumen and supporting member may be present in thedelivery shaft303.
• In another embodiment, a supporting member may consist of a member (not shown) that is coupled to thedistal end334 of a steering lumen included within thedelivery shaft303. The steering lumen can be theguidewire lumen312 shown inFIGS. 11A-11B. The supporting member may extend from thedistal end334 to theproximal end332 of thedelivery shaft303. In one embodiment, pulling on this supporting member at theproximal end332 causes thedistal end334 of the delivery shaft to become curved. In another embodiment, the steering lumen is pressurized causing the distal end of the delivery system to bend in a desired direction.
• In one embodiment, theguide wire lumen312 may only be present in thedistal end332 of thedelivery shaft303 as in common rapid exchange catheter design as is known in the art. In another embodiment, theguide wire lumen312 may absent from thedelivery shaft303 and may be replaced by one or more tendons to produce a bendabletip delivery shaft303.
• Thedelivery shaft303 may made out of numerous different types of materials similar to the material used to make thedelivery shaft300 described above. Also, similar to thedelivery shaft300, thedelivery shaft303 may also comprise at least one radiopaque marker or an MRI marker to aid the operator (e.g., a physician) in the monitoring, placing, or inserting of thedelivery shaft303 into a patient.
• FIGS. 12A-12G illustrate an exemplary deployment shaft that can be used with themedical device302 to deploy theligature100. The deployment shaft can be thedeployment shaft307 or309 shown inFIGS. 11A-11B. In one embodiment, thedeployment shaft307 shown inFIG. 12A is disposed within thedeployment tube336 as shown inFIG. 12B. In one embodiment, thedeployment shaft307 includes aslot342 wherein a portion of theligature100 can reside until deployment. Theslot342 is useful in that it helps keep the ligature100 from being entangled between twodeployment shafts307 and309. Theslot342 is not necessary for thedeployment shaft307 or309 to function properly in deploying theligature100.
• In one embodiment, a portion of theligature100 proximate the anchoringmember104A is spiraled around the deployment shaft307 (as shown inFIG. 12D); and, the other portion of theligature100 proximate the anchoringmember104B would be spiraled around thedeployment shaft309 in a similar manner (not shown). In the embodiment where thedeployment shafts307 and309 each includes aslot342, the portion of theligature100 that is not wound around thedeployment shafts307 and309 extends through theslot342. Theligature100 extending from oneslot342 of one deployment shaft (e.g., deployment shaft307) can be inserted into anotherslot342 on another deployment shaft (e.g., deployment shaft309).
• In one embodiment, the distal end of thedeployment shaft307 further comprises anaxis344 such that thehelix anchoring member104A can be kept there or releasably coupled thereto until the deployment of theligature100. Thedeployment shaft307 with theligature100 releasably coupled thereto can be disposed within thedeployment tube336 as illustrated inFIG. 12E. FIGS.12F-G further illustrates thedistal end334 of thedelivery shaft302 wherein thedeployment shafts307 and309 are disposed within thedeployment tube336 and338, respectively.
• It is to be appreciated that a similar construction to thedeployment shaft307 can used for theligature100 with the barbed end configurations for the anchoringmember102A and102B described above. In this embodiment, the barbed end will be kept at theaxis344 until after deployment.
• FIGS. 13A-13H illustrate an exemplary process of deploying theligature100 that includes helix ends anchoring members. AtFIGS. 13A-13B, thedeployment tube336 is advanced in order to advance the deployment shaft307 (not visible in these figures) toward atissue area344. Advancing thedeployment shaft307 would advance the helix ends104A toward thetissue area344. In one embodiment, thedeployment tube336 is advanced toward thetissue area344 by a deployment mechanism, such as thedeployment mechanism350A shown inFIG. 11. After the advancement, thedeployment shaft307 is then rotated by a rotating mechanism such as therotating mechanism314 shown inFIG. 11. In this case, the linkage portion of theligature100 which joins the two anchoring members, the helix ends104A and104B, is flexible and twistable so that one helix end can be rotated while the other helix end is not. As thedeployment shaft307 is rotated, thehelix end104A is also rotated allowing it to pierce through thetissue area344 as illustrated inFIG. 13C. In one embodiment, upon advancing, thehelix end104A is rotated in a direction that would enhance the advancement of the helix end104A into thetissue area344. The rotation of thedeployment shaft307 is initiated by a rotation of the rotating mechanism. Once thehelix end104A is anchored to thetissue area344, thedeployment tube336 together with theshaft307 is retracted into thedelivery shaft303 leaving thehelix end104A embedded (or anchored) in thetissue area344 as illustrated inFIG. 13D. This process can be repeated for thehelix end104B of theligature100.
• As shown inFIGS. 13D-13E, thedeployment tube338 is advanced out of thedelivery shaft303 to advance thedeployment shaft309 to atissue area346. Advancing thedeployment shaft309 would advance thehelix end104B toward thetissue area346. After the advancement, thedeployment shaft309 is rotated by a rotating mechanism such as therotating mechanism316 shown inFIG. 11. As thedeployment shaft309 is rotated, thehelix end104B is also rotated allowing it to pierce through thetissue area346 as illustrated in FIGS.13E-F. In one embodiment, upon advancing, thehelix end104B is rotated in a direction that would enhance the advancement of thehelix end104B into thetissue area346. Once thehelix end104B is anchored to thetissue area346 as shown inFIG. 13F, thedeployment shaft309 is retracted into thedelivery shaft303 leaving thehelix end104B embedded in thetissue area346 as illustrated in FIGS.3G-H.
• After the helix ends104A and104B are anchored to thetissue area344 and346, respectively, thedelivery shaft303 may then be retracted from thetissue area344 and346. The process described inFIGS. 13A-13H may be repeated as needed to deploy asmany ligatures100 as necessary. In one embodiment, the process is used to constrict a heart valve such as a mitral valve by placingmultiple ligatures100 across the mitral valve's annulus. In one embodiment, thetissue area344 and346 are the fibrous tissue around the annulus of the mitral valve. The anchoring of the helix ends104A and104B thus places theligature100 across the heart valve to reduce or constrict the size of the heart valve. Theligatures100 with the helix ends can be placed across the mitral valve using this process to place theligatures100 similarly to what is depicted inFIGS. 4 and 5.
• FIG. 14A illustrates an exemplary route of percutaneously inserting theligatures100 into a patient'sheart110. As previously mentioned, by percutaneous deployment, theligature100 is deployed through blood vessels, veins, or arteries into a patient. In one embodiment, theligature100 is deployed through the blood vessels, veins, or arteries and into the heart area of a patient.
• In one embodiment,FIG. 14A illustrates an exemplary route of percutaneously inserting theligatures100 into theheart110 and placing theligatures100 across themitral valve120 of theheart110. In one embodiment, a medical device containing theligature100 is introduced into the patient's body percutaneously using a modified Seldinger technique in which the medical device is inserted into the venous vascular tree through the femoral vein. In one embodiment, the medical device enters or reaches the annulus of themitral valve120 from the atrial side of theheart110. Amedical device130 is first provided. Themedical device130 can be themedial device301 or themedical device302 described above. Themedical device130 can also be a catheter capable of delivering and deploying aligature100 to the heart. Themedical device130 is advanced up the inferior vena cava (IVC)122 and into the right atrium (RA)112 of theheart110. Themedical device130 then enters then left atrium (LA)114 of theheart110. In one embodiment, themedical device130 crosses theatrial septum124 through a small atrial septostomy (created by cardiological techniques known in the art) to enter theleft atrium114 of theheart110. In one embodiment, a guidewire (not shown) is placed across the atrial septostomy and themedical device130 is threaded along the guidewire and into theleft atrium114. Themedical device130 is stopped at a predetermined point in, at, or in proximity to themitral valve120. In one embodiment, themedical device130 may have a preformed or deflectable short hook configuration at its tip region to facilitate the insertion of themedical device130 into the mitral valve area. Once themedical device130 reaches the area in, at, or in proximity tomitral valve120, theligature100 can be deployed as previous described and be placed across the mitral valve in similar manners as those shown inFIGS. 4-5.
• FIG. 14B illustrates an exemplary route of percutaneously inserting theligatures100 into a patient'sheart110 to perform a ventricular remodeling of the heart. In ventricular remodeling, the ligature (or ligatures)100 can be used to reduce the size of the ventricle by placing these ligatures around the left ventricle (which is typically the ventricle that is enlarged due to a faulty mechanism in the heart such as regurgitation). With theligatures100 placed around the left ventricle, the size of the left ventricle can be reduced, hence, remodeled.
• Continuing withFIG. 14B, in one embodiment, amedical device130 is first provided. In one embodiment, themedical device130 can be themedial device301 or themedical device302 described above. In another embodiment, themedical device130 can be a catheter capable of delivering and deploying aligature100 to the heart. Themedical device130 is advanced up the inferior vena cava (IVC)122 and into the right atrium (RA)112 of theheart110. Themedical device130 then enters then left atrium (LA)114 of theheart110. In one embodiment, themedical device130 crosses theatrial septum124 through a small atrial septostomy (created by cardiological techniques known in the art) to enter theleft atrium114 of theheart110. In one embodiment, a guidewire (not shown) is placed across the atrial septostomy and themedical device130 is threaded along the guidewire and into theleft atrium114. Themedical device130 is advanced through themitral valve120 to enter theleft ventricle118. In one embodiment, themedical device130 may have a preformed or deflectable short hook configuration at its tip region to facilitate the insertion of themedical device130 into the mitral valve area. Once themedical device130 is inserted through themitral valve120, theligature100 can be deployed as previous described to anchor one of the anchoring members into the papillary muscles in theleft ventricle118 and the other anchoring member into a cardiac tissue opposite the heart muscles. This process is repeated to deployseveral ligatures100 as it may be necessary to employ more than one ligature to reduce the size of an enlarged left ventricle. In one embodiment, afterseveral ligatures100 have been deployed, the ligatures surround theleft ventricle118 as shown inFIG. 14B.
• FIG. 14C illustrates another exemplary route of percutaneously inserting theligatures100 into a patient'sheart110 to perform a ventricular remodeling of the heart. Amedical device130 is first provided. In one embodiment, themedical device130 can be themedial device301 or themedical device302 described above. In another embodiment, themedical device130 can be a catheter capable of delivering and deploying aligature100 to the heart. Themedical device130 is advanced up theaorta119 and directly into theleft ventricle118. In one embodiment, themedical device130 may have a preformed or deflectable short hook configuration at its tip region to facilitate the insertion of themedical device130 into theleft ventricle118. Once themedical device130 reaches theleft ventricle118, theligature100 is deployed as previous described to place theligature100 into the tissues of theleft ventricle118. One such tissue is the heart muscles in theleft ventricle118. This process is repeated to deployseveral ligatures100 as it may be necessary to employ more than one ligature to reduce the size of an enlarged left ventricle. In one embodiment, afterseveral ligatures100 have been deployed, the ligatures span the interior of theleft ventricle118 as shown inFIG. 14C.
• FIG. 15A illustrates an alternative embodiment of placing theligature100 around a mitral valve. In this embodiment, theligature100 described previously is placed within the coronary sinus212 of theheart202. The coronary sinus212 substantially encircles themitral valve annulus206 of themitral valve204. A first anchoring member of the ligature100 (e.g., thefirst anchoring member102A) extends outside one end of thecoronary sinus218 and anchors into theleft fibrous trigone210. A second anchoring member of the ligature100 (e.g., thesecond anchoring member102B) extends outside thecoronary sinus218 and anchors into the rightfibrous trigone200. In one embodiment, theligature100 has a preformed shape such that once theligature100 is deployed and that the first and the second anchoring members are anchored, theligature100 bends and reduces the radius of curvature of thecoronary sinus218. In this embodiment, theligature100 can be made of a shape memory material and may be flexible or rigid. Theligature100 may be made of a shape memory material such as Nitinol or other material that has a memory of an original shape as shown inFIG. 15B and can be temporarily stretched or forced into another shape during deployment as shown inFIG. 15C andFIG. 15D. Since thecoronary sinus218 substantially encircles themitral valve annulus206, the reduction of the radius of curvature of the bentcoronary sinus218 will result in a diameter and circumference reduction of themitral valve annulus206. In one embodiment theligature100 is surrounded or encapsulated by a jacket so as to prevent theligature100, once deployed within thecoronary sinus218, from cutting through thecoronary sinus218.
• FIG. 16 illustrates anexemplary method150 of treating a faulty heart valve by constricting or reducing the size of the heart valve. Atoperation152, a medical device such as themedical device301 or302 described above is provided. Atoperation154, theligature100 is deployed into the patient wherein the first deployment shaft (e.g., thedeployment shaft310A, or307) deploys the first anchoring member (e.g., the anchoringmember102A or104A) to a first tissue area around the heart valve and the second deployment shaft (e.g., the deployment shaft3101B, or309) deploys the second anchoring member (e.g., the anchoringmember102B or104B) to a second tissue area of the heart valve. Theligature100 can be deployed using the embodiments previously described. Deploying theligature100 anchors the first anchoring member to the first tissue area and the second anchoring member to the second tissue area as described above. Themethod150 can be repeated in embodiments wheremultiple ligatures100 are to be placed across the heart valve. The number ofligatures100 sufficient to treat a faulty heart valve depends on how much of the size of the faulty heart valve needs to be constricted or reduced. The cross section size of each of theligatures100 is sufficiently small so as to not cause thrombus or to not significantly impede the blood flow through the heart valve. The length of each of theligatures100 can be varied depending on the area theligature100 needs to constrict or reduce.
• The percutaneous methods described above can be used to place the ligature(s)100 across the mitral valve to constrict (or reduce) the size of a faulty or defective heart valve. In one embodiment, theligatures100 are placed across the mitral valve in order to prevent back flow of blood that a patient with a regurgitation condition caused by a faulty mitral valve would experience. The described medical devices including theligatures100 that enable percutaneous introduction of theligatures100 into patients can replace those cases that require surgical procedures to reduce or constrict the mitral valve. Such a percutaneous method also reduces patient discomfort, improves recovery time, and reduces hospitalization time relatives to a surgical procedure in which the chest is opened.

Claims (37)

1-8. (canceled)

9. A medical device comprising:

a delivery shaft having a delivery lumen, a proximal end, and a distal end;

a first deployment shaft disposed within said delivery lumen and extending from said proximal end to said distal end;

a second deployment shaft disposed within said delivery lumen and extending from said proximal end to said distal end;

a ligature having a first anchoring member and a second anchoring member is releasably coupled to said delivery shaft;

said delivery shaft to deploy said ligature into a patient wherein said first deployment shaft to deploy said first anchoring member to a first tissue area of said patient and said second deployment shaft to deploy said second anchoring member to a second tissue area of said patient.

10. The medical device as inclaim 9 further comprises a delivery handle coupling to said delivery shaft at said proximal end, said delivery handle further comprises a first deployment mechanism and a second deployment mechanism wherein said first deployment mechanism deploys said first anchoring member to said first tissue area and said second deployment mechanism deploys said second anchoring member to said second tissue area.

11. The medical device as inclaim 10 wherein said delivery handle further comprises a first rotating mechanism and a second rotating mechanism wherein said first rotating mechanism deploys rotates said first anchoring member to pierce said first anchoring member into said first tissue area and said second rotating mechanism rotates said second anchoring member to pierce said second anchoring member into said second tissue area.

12. The medical device as inclaim 9 wherein said delivery shaft is pre-shaped to allow said delivery shaft to be maneuvered to an area within said patient.

13. The medical device as inclaim 9 further comprises a guidewire disposed within said delivery shaft to guide said delivery shaft to an area within said patient.

14. The medical device as inclaim 9 further wherein said delivery shaft further comprises a first deployment lumen, a second deployment lumen, and a guidewire lumen wherein said first deployment shaft is disposed within said first deployment lumen, said second deployment shaft is disposed within said second deployment lumen, and said guidewire is disposed within said guidewire lumen.

15. The medical device as inclaim 9 wherein said delivery shaft further comprises a lumen that is to be pressurized to facilitate maneuvering of said delivery shaft.

16. The medical device as inclaim 9 further comprises a support member disposed within said delivery shaft extending from said distal end to said proximal end, said support member having a shape that curves said delivery shaft to facilitate maneuvering of said delivery shaft.

17. The medical device as inclaim 9 wherein said first anchoring member and said second anchoring member have configurations of one of a barbed end, a helical end, and a hooked end.

18. The medical device as inclaim 9 wherein said ligature is made from one of an elastomeric material, a superelastic material, a flexible material, a shape memory material, and a rigid material.

19. The medical device as inclaim 9 wherein said ligature is made out of a stretchable material.

20. The medical device as inclaim 19 wherein during deployment, said ligature is stretched and after said deployment, said ligature is returned to an unstretched length.

21. The medical device as inclaim 9 wherein said ligature has a cross section size sufficiently small to not significantly impede a blood flow through an area where said ligature is anchored across.

22. The medical device as inclaim 9 wherein said ligature is placed across a heart valve to constrict said heart valve, said ligature to have a cross section size sufficiently small to not significantly impede a blood flow through said heart valve.

23. The medical device as inclaim 22 wherein said heart valve is a mitral valve.

24. A method of constricting a heart valve of a patient comprising:

providing a medical device comprising a delivery shaft having a delivery lumen, a proximal end, and a distal end, said delivery shaft further comprises a first deployment shaft and a second deployment shaft disposed within said delivery lumen, said delivery shaft further comprises a ligature releasably coupled thereto, said ligature having a first anchoring member and a second anchoring member; and

deploying said ligature into said patient wherein said first deployment shaft deploys said first anchoring member to a first tissue area around said heart valve and said second deployment shaft deploys said second anchoring member to a second tissue area of said heart valve, and wherein said deploying anchors said first anchoring member to said first tissue area and said second anchoring member to said second tissue area.

25. The method ofclaim 24 wherein said first tissue area and said second tissue area are substantially opposite from each other.

26. The method as inclaim 24 said delivery shaft is further coupled to a delivery handle having a first deployment mechanism and a second deployment mechanism wherein said first deployment mechanism deploys said first anchoring member and said second deployment mechanism deploys said second anchoring member.

27. The method as inclaim 26 wherein said delivery handle further comprises a first rotating mechanism and a second rotating mechanism wherein said first rotating mechanism deploys rotates said first anchoring member to pierce said first anchoring member into said first tissue area and said second rotating mechanism rotates said second anchoring member to pierce said second anchoring member into said second tissue area.

28. The method as inclaim 24 wherein said first anchoring member and said second anchoring member have configurations of one of a barbed end, a helical end, and a hooked end.

29. The method as inclaim 24 wherein said ligature is made from one of an elastomeric material, a superelastic material, a flexible material, a shape memory material, and a rigid material.

30. The method as inclaim 24 wherein said ligature is made out of a stretchable material.

31. The method as inclaim 30 wherein said ligature is returnable to said first length after said first anchoring member is anchored to said first tissue area and said second anchoring member is anchored to said second tissue area.

32. The method as inclaim 24 wherein said ligature has a cross section size sufficiently small to not significantly impede a blood flow through said heart valve when said ligature is anchored across said heart valve.

33. The method as inclaim 24 wherein said heart valve is a mitral valve.

34. The method as inclaim 24 wherein said ligature is deployed percutaneously into said patient wherein said ligature is deployed though a blood vessel.

35. A method of constricting a heart valve of a patient comprising:

providing a medical device comprising a delivery shaft having a delivery lumen, a proximal end, and a distal end, said delivery shaft further comprises a first deployment shaft and a second deployment shaft disposed within said delivery lumen;

coupling a first ligature to said delivery shaft and deploying said first ligature to a heart valve area of said patient;

coupling a second ligature to said delivery shaft and deploying said second ligature to said heart valve area of said patient;

wherein each ligature of said first ligature and second ligature has a first anchoring member and a second anchoring member;

wherein said first deployment shaft deploys said first anchoring member to anchor said first anchoring member to said heart valve area to constrict said heart valve, said second deployment shaft deploys said second anchoring member to anchor said second anchoring member to said heart valve area to constrict said heart valve.

36. The method ofclaim 35 wherein said delivery shaft deploys said first ligature and said second ligature sequentially.

37. The method ofclaim 35 wherein said first anchoring member of each of said first ligature and said second ligature is anchored to a tissue area around said heart valve that is opposite from another tissue area around said heart valve where said second anchoring member of each of said first ligature and said second ligature is anchored to.

38. The method ofclaim 37 wherein said first ligature and said second ligature are parallel to one another after said first ligature and said second ligature are deployed and anchored to said heart valve.

39. The method ofclaim 37 wherein said first ligature and said second ligature are intersect one another after said first ligature and said second ligature are deployed and anchored to said heart valve.

40. The method as inclaim 35 wherein said first ligature and said second ligature are deployed percutaneously into said patient wherein said first ligature and said second ligature are deployed though blood vessels.

41. A method of constricting a ventricle of a patient comprising:

providing a medical device comprising a delivery shaft having a delivery lumen, a proximal end, and a distal end, said delivery shaft further comprises a first deployment shaft and a second deployment shaft disposed within said delivery lumen, said delivery shaft further comprises a ligature releasably coupled thereto, said ligature having a first anchoring member and a second anchoring member; and

deploying said ligature into the heart of said patient wherein said first deployment shaft deploys said first anchoring member to a first tissue area of said ventricle and said second deployment shaft deploys said second anchoring member to a second tissue area of said ventricle, wherein said deploying anchors said first anchoring member to said first tissue area and said second anchoring member to said second tissue area.

42. The method ofclaim 41 wherein said first tissue area is a papillary muscle of said ventricle and wherein said second tissue area is another papillary muscle of said ventricle that is substantially opposite said first tissue area.

43. The method as inclaim 41 wherein said ligature is deployed percutaneously into said patient wherein said ligature is deployed though blood vessels.

44. A method of constricting a mitral valve of a patient comprising:

providing a medical device comprising a delivery shaft having a delivery lumen, a proximal end, and a distal end, said delivery shaft further comprises a first deployment shaft and a second deployment shaft disposed within said delivery lumen, said delivery shaft further comprises a ligature releasably coupled thereto, said ligature having a first anchoring member and a second anchoring member; and

deploying said ligature is within a coronary sinus that substantially encircles said mitral valve;

deploying said first anchoring member to a first tissue area around said mitral valve;

deploying said second anchoring member to a second tissue area around said mitral valve; wherein

said first deployment shaft deploys and anchors said first anchoring member to said first tissue area and said second deployment shaft deploys and anchors said second anchoring member to said second tissue area.

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