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Publication numberUS20050149014 A1
Publication typeApplication
Application numberUS 11/058,957
Publication dateJul 7, 2005
Filing dateFeb 15, 2005
Priority dateNov 15, 2001
Also published asUS6575971, US6926715, US7938827, US8216230, US20030093071, US20090270858, US20110178596
Publication number058957, 11058957, US 2005/0149014 A1, US 2005/149014 A1, US 20050149014 A1, US 20050149014A1, US 2005149014 A1, US 2005149014A1, US-A1-20050149014, US-A1-2005149014, US2005/0149014A1, US2005/149014A1, US20050149014 A1, US20050149014A1, US2005149014 A1, US2005149014A1
InventorsWallace Hauck, Samuel Lichtenstein
Original AssigneeQuantumcor, Inc., Evalve, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Cardiac valve leaflet attachment device and methods thereof
US 20050149014 A1
Abstract
A medical device system comprising a guide catheter and a leaflet fastening applicator, the guide catheter having suitable dimensions for deployment and insertion percutaneously into a human heart in a vicinity of a heart valve, the leaflet fastening applicator having a size allowing insertion through the guide catheter and being capable of holding portions of opposing heart valve leaflets, wherein the fastening applicator comprises a pair of grasping-electrodes adapted for holding and engaging the portions of opposing heart valve leaflets together and for applying energy to fasten the portions, in which heart valve leaflets can be captured and securely fastened, thereby improving coaptation of the leaflets and improving competence of the valve.
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Claims(16)
1. A method for fastening a portion of a first valve leaflet with a portion of a second valve leaflet in a patient, said method comprising:
holding said portion of the first valve leaflet in contact with said portion of the second valve leaflet; and
applying energy to securely fasten said two portions together.
2. The method of claim 1, wherein the energy comprises an energy source selected from the group consisting of radiofrequency energy, ultrasound energy, laser energy, microwave energy, and electromagnetic energy.
3. The method of claim 1, wherein holding comprises applying suction to hold said portion of the first valve leaflet in contact with said portion of the second valve leaflet.
4. The method of claim 1, wherein holding comprises grasping the leaflets with a grasper.
5. The method of claim 1, wherein holding comprises portions of opposing valve leaflets with a leaflet fastening applicator.
6. A method for treating a valvular annulus, said method comprising:
fastening portions of two opposite leaflets; and
applying energy to the valvular annulus to shrink at least a portion of the annulus tissue.
7. The method of claim 6, wherein fastening comprises:
holding a portion of the first valve leaflet in contact with a portion of the second valve leaflet; and
applying energy to securely fasten said portions of two opposite leaflets together.
8. The method of claim 7, wherein the energy comprises an energy source selected from the group consisting of radiofrequency energy, ultrasound energy, laser energy, microwave energy, and electromagnetic energy.
9. The method of claim 7, wherein holding comprises applying suction to hold said portion of the first valve leaflet in contact with said portion of the second valve leaflet.
10. The method of claim 6, wherein fastening portions of two opposite leaflets and applying energy are carried out percutaneously.
11. The method of claim 6, wherein the applied energy comprises radiofrequency energy.
12. The method of claim 6, wherein the applied energy comprises ultrasound energy.
13. The method of claim 6, wherein the applied energy comprises microwave energy.
14. The method of claim 6, wherein the applied energy comprises laser energy.
15. The method of claim 7, wherein holding comprises grasping the leaflets with a grasper.
16. The method of claim 7, wherein holding comprises portions of opposing valve leaflets with a leaflet fastening applicator.
Description
    CROSS-REFERENCES TO RELATED APPLICATIONS
  • [0001]
    This patent application is a divisional of application Ser. No. 10/457,757 (Attorney Docket No. 020489-001830US), filed on Jun. 9, 2003, which was a continuation-in-part application of application Ser. No. 10/000,992 filed Nov. 15, 2001, entitled “Cardiac Valve Leaflet Stapler Device and Methods Thereof”, now U.S. Pat. No. 6,575,971, the full disclosures of which are incorporated herein by reference.
  • BACKGROUND OF THE INVENTION
  • [0002]
    Field of the Invention
  • [0003]
    The present invention generally relates to new coupling devices and methods for use. More particularly, this invention relates to a percutaneous device, which grasps, secures, and then attaches two adjacent heart valve leaflets with staples or an RF coupling element causing a shortening of the leaflet in the desired direction or orientation. The invention also relates to a method for treating a valvular annulus comprising steps of fastening portions of two opposite leaflets and applying energy to the valvular annulus adapted for shrinking at least a portion of the annulus tissue.
  • [0004]
    The heart is a four-chambered organ located in the thoracic space. The heart is responsible for pumping blood through the body, through two distinct circuits. One circuit takes blood low in oxygen from the systemic venous system, which collects in the right atrium (one chamber). The atrium pumps the blood into the immediately lower chamber, the right ventricle. In passing from the atrial chamber to the ventricular chamber, the blood passes through the “tricuspid” valve opening, so named because of the three leaflets (cusps) of the valve. The right ventricle contracts to pump the blood into the lungs (second circuit) and in so contracting, forces the tricuspid valve leaflets closed, thus preventing backflow of blood into the right atrium.
  • [0005]
    The oxygenated blood flowing back to the heart from the lungs enters the left atrium (third chamber) and collects there until the atrium contracts and pumps the blood through the mitral valve into the immediately lower chamber, the left ventricle, during diastole. When the left ventricle contracts to pump the blood into the systemic circulation (back to the first circuit) during systole, the mitral valve leaflets are closed, preventing backflow of blood into the left atrium and the pulmonary circulation. The mitral valve is comprised of two valve leaflets. The atria contract simultaneously, as do the ventricles.
  • [0006]
    Another set of valves is present in the main artery of the left ventricle, the aorta and the main artery of the right ventricle, the pulmonary artery. These valves are called the aortic and pulmonary valves, respectively and they are similar in appearance.
  • [0007]
    The anatomy of the mitral and tricuspid valves is similar, but quite distinctly different from the anatomy of the aortic and pulmonary valves. These valves are comprised of the following six different components: the left (or right) atrial wall, the left (or right) ventricular wall, the annulus, the leaflets, the chordae tendinae and the papillary muscles. The annulus is a zone of junction that serves as the attachment of the muscular fibers of the atrium and the ventricle and as the attachment of the mitral (or tricuspid) valve. Annular tissue is pliable permitting contraction of the annular ring when the ventricles contract and thus narrowing the aperture.
  • [0008]
    The annulus forms the foundation for the leaflets, which are secured to the ventricular wall by way of the chordae tendinae, thin fibrous cords attaching the free edges of the leaflets to the papillary muscles, which are elevations or extensions of the ventricular wall. All structures are covered by endothelial cell lining but the contractile elements (muscles) of the atria and ventricles are capable of independent movement. The other structures are largely fibrous in nature, composed of dense fibrous connective tissue and collagen.
  • [0009]
    When the ventricles contract during systole, the pressure within the ventricles forces the leaflets upward until the free edges contact. This is called coaptation. The free edges of the leaflets are inhibited by the chordae tendinae from prolapsing beyond the plane of the annulus and into the atrial chambers. When the normal mitral or tricuspid valves close, the valve becomes competent and no blood escapes through the annulus. The operation of these valves (plus the normal closure of the aortic and pulmonary valves) ensures that the heart functions as a one-way pump.
  • [0010]
    As one understands the complex operation of the mitral or tricuspid valves, one can begin to appreciate the number of possible causes for failure of proper function of these valves. Some of these are: loss of pliability of the annulus leading to decreased contractibility; widening of the annulus; thickening, shortening or swelling of the leaflets; dilation of the ventricle; elongation or breaking of the chordae tendinae; and elongation of the attachment of the chordae tendinae with the papillary muscles or ventricular wall.
  • [0011]
    Individual or combinations of these causes for failure eventually lead to loss of coaptation of the leaflets, loss of competence of the valve and decreased efficiency of the heart as a one-way pumping mechanism. When the latter occurs, various symptoms are seen in the patients, including breathlessness or lack of stamina and heart murmurs.
  • [0012]
    Repair of the incompetent valves is designed to address two functional conditions of the leaflets, either the opening or closing of the leaflets is increased or restricted. The former condition, called leaflet prolapse, exists when the free edge of one leaflet overrides the annulus when the ventricles contract. The latter condition occurs when the restricted leaflet motion prevents the leaflets from opening. The other possible functional condition is where the valve leaflets may be functionally normal, but the annulus does not contract or is too enlarged. When this occurs the leaflets will not close effectively.
  • [0013]
    The current accepted modes of treatment of these conditions described for the mitral and tricuspid valves include the following: valvuloplasty, in which the affected leaflets are remodeled to perform normally; repair of the chordae tendinae and/or papillary muscle attachments; and surgical insertion of an “annuloplasty” ring. This requires suturing a flexible support ring over the annulus and tucking the annulus to constrict the radial dimension.
  • [0014]
    Each of these procedures requires open-heart surgery and cardiopulmonary bypass procedure, in which the heart is removed from the blood circuits as the circuits have been described above and a pumping system circulates the blood through the patient during the surgical procedure. The heartbeat is stopped and the heart is usually cooled and infused with a cold nutrient solution during the procedure. Open-heart surgery with cardiopulmonary bypass is a very expensive procedure, requiring considerable time, multiple surgeons and a host of assisting personnel to operate the equipment, monitor the patient and proceed with caution but quickly for the patient's benefit. These procedures are also associated with serious risks, including death and adverse events for the patient and the patient has a long painful course of recovery, first in the hospital, then at home.
  • [0015]
    Oz et al. in U.S. Pat. No. 6,269,819 discloses an apparatus for repairing valve leaflets comprising a grasper capable of grabbing and co-apting the leaflets of valve to cure mitral regurgitation. The principles of the “grasper” arrangement and its mechanism as disclosed are incorporated herein by reference. Oz et al. does not disclose a medical system having a fastening applicator that comprises a pair of grasping-electrodes means adapted for holding and engaging portions of opposing heart valve leaflets together and for applying suitable energy to fasten the portions.
  • [0016]
    Robertson et al. in U.S. Pat. No. 6,203,553 discloses a surgical stapler for securing a prosthetic heart valve within a patient by driving a first leg of the stapler assembly through a peripheral cuff of the prosthetic heart valve and crimping a second leg of the stapler assembly in a direction toward the first leg such that the second leg pierces a portion of heart tissue surrounding the prosthetic valve for securing purposes. The principles of “stapler” arrangement and its securing mechanism as disclosed are incorporated herein by reference. Robertson et al. does not disclose a medical system having a fastening applicator that comprises a pair of grasping-electrodes means adapted for holding and engaging portions of opposing heart valve leaflets together and for applying suitable energy to fasten the portions.
  • [0017]
    This invention discloses a series of devices to be used to repair leaking valves with normal leaflets (that is, abnormal annulus) or leaflet prolapse, without the disadvantages associated with open-heart surgery, because the device is inserted into the heart via the blood vessels, through the skin in the groin or neck area percutaneously. During the procedure, the patient may be awake, sedated or anesthetized and the device and progress of the procedures are monitored and guided using fluoroscopy and echocardiography, both non-invasive methods, in the continuously beating heart. Obviously fewer personnel are required to assist with the procedure. When the procedure is completed the patient may be discharged within hours to days. All of these contrasting features to open-heart procedures make the use of the stapling device a potentially valuable resource for the interventional cardiologist. These specialists will be able to add yet another “minimally invasive” procedure for treatment of their patients.
  • BRIEF SUMMARY OF THE INVENTION
  • [0018]
    In general, it is an object of the present invention to provide a method and an improved medical device for attaching adjacent leaflet edges or foreshortening individual leaflets. The leaflets referred to herein include mitral and tricuspid leaflets, and may also include aortic and pulmonary valve leaflets, venous valve leaflets, defects within the heart in the atria or ventricles and any other intravascular structure(s) which may need to be stapled together or foreshortened as described for the mitral and tricuspid valves.
  • [0019]
    It is another object of the present invention to provide a method and device for approaching the desired location on a leaflet and attaching the device to the desired location on the leaflet through various means, including suction or metallic hooks. For example, using suction, the end of the leaflet holder device is placed upon the leaflet and a negative pressure (suction) is applied wherein the leaflet tissue is sucked for a short distance into the end of the leaflet holder device.
  • [0020]
    It is another object of the present invention to provide a method and device for approaching an adjacent leaflet edge and securing the leaflet by one of various means, such that when the two leaflet holding devices containing the secured leaflets are withdrawn into the distal end of the tubular gripper, the two leaflet edges are in close apposition, possibly touching each other. The device system may apply suction to grip at least two of the heart valve leaflets to enter the lumen of the tubular gripper adapted for fastening the portions of opposing heart valve leaflets together.
  • [0021]
    It is still another object of the present invention to provide a method and device for attaching two leaflets or for foreshortening one leaflet by insertion of a metal or plastic staple, which when crimped physically or electronically, permanently attaches the staple to the one or two leaflets. The configuration of the staple may be linear, curved, kinked, spiral or any other configuration that would permanently secure the leaflet(s).
  • [0022]
    It is further another object of the present invention to provide a method and device for transporting the staple to the desired site of attachment, in the proper position to accomplish the attachment, without the possibility of releasing the free staple into the heart chamber. Following the attachment the staple must be released from its holder and then the secured leaflet(s) will then be released from the leaflet holding device(s). The method and device of securing the staple prior to its insertion into the leaflet(s) may be through use of a breakable fiber or a metallic link. For example, the metallic link may be one that is broken at a specified temperature. When electrical energy, such as radiofrequency voltage is applied to the metallic line, the temperature rises to a level wherein the link is broken and the previously attached staple becomes free from its metallic line tether.
  • [0023]
    In one preferred embodiment, it is provided a device system for treating a valvular annulus comprising a guide catheter and a leaflet fastening applicator, the guide catheter having suitable dimensions for deployment and insertion into a human heart in a vicinity of a heart valve and comprising a non-ablative energy means for shrinking at least a portion of the valvular annulus, the leaflet fastening applicator having a size allowing insertion through the guide catheter and being capable of holding portions of opposing heart valve leaflets, wherein the fastening applicator comprises a pair of grasping-electrodes adapted for holding and engaging the portions of opposing heart valve leaflets together and for applying radiofrequency energy to fasten the portions, wherein a first of the grasping-electrodes comprises a plurality of spikes and a second of the grasping-electrodes comprises a plurality of recesses configured to receivably match and engage the spikes of the first grasping-electrode, wherein the catheter comprises at least a gripper inside the catheter, the gripper having a suitable opening sized and configured for applying vacuum suction to releasably grip one of the heart valve leaflets.
  • [0024]
    Further, a method for fastening portions of opposing heart valve leaflets in a patient, the method comprising means for holding the portions of opposing heart valve leaflets close to each other and applying energy to jointly fasten the portions together. Some aspects of the invention relate to a method for fastening a portion of a first valve leaflet with a portion of a second valve leaflet in a patient, comprising steps of holding the portion of the first valve leaflet in contact with the portion of the second valve leaflet and applying a plurality of energy sources to securely fasten the two portions together, wherein the plurality of energy sources is selected from a group consisting of radiofrequency energy, ultrasound energy, laser energy, microwave energy, and electromagnetic energy.
  • [0025]
    It is another preferred object to provide a method for fastening a first edge of a first valve leaflet to a second edge of an opposite second valve leaflet in a patient, the method comprising: first, introducing a medical device into a vicinity of a valve needed for repairing, the medical device comprising a catheter and a leaflet fastening applicator, the catheter having suitable dimensions for deployment and insertion into the patient in the vicinity of the valve, the leaflet fastening applicator having a size allowing insertion through the catheter and being capable of holding the first edge of the first valve leaflet to the second edge of the opposite second valve leaflet, wherein the fastening applicator comprises a pair of fastening elements adapted for holding and engaging the first edge and second edge of valve leaflets close to each other; and applying energy to the fastening elements to securely fasten the first edge of the first valve leaflet to the second edge of the second valve leaflet.
  • [0026]
    Briefly, access to the blood vascular system is obtained through a skin puncture over a peripheral vein or artery. An introducer device is used to secure the vascular access and a guidewire is passed down the introducer into the vessel and advanced into the heart. A guide catheter is placed over the guidewire and advanced over the guidewire to the desired position in the heart. The guidewire is withdrawn from the guide catheter and the leaflet holder device is inserted and advanced into the guide catheter to the desired location in the heart. The leaflet holder device is then manipulated into position and the leaflet(s) is/are secured and the tips of the leaflet holder device are withdrawn slightly into the end of the guide catheter. When the interventional cardiologist is confident that the proper position on the leaflet(s) is secured, the staple(s) located in the end of the guide catheter is/are attached to the leaflet(s). The staple is then released from the guide catheter attachment via breakable fiber or breakable metallic link. Finally, the leaflet(s) is/are released from the leaflet holding device and the leaflet(s) is/are free to function with the restrictions imposed by the staple. Multiple sites may be stapled in the same procedure.
  • [0027]
    In one embodiment, the leaflet holding device consists of a tube used to attach and secure one leaflet. Use of two such leaflet holder devices enables the user to grasp and secure two leaflets. In the embodiment, the guide catheter, a separate tube-shaped device, contains the staples and the staple securing system.
  • [0028]
    In another embodiment, the leaflet holder device and the guide catheter/staple holding device are one and the same device. In this device, the staple holding device may be stationary or may be moveable for some part of the length of the guide catheter.
  • [0029]
    Some aspects of the invention relate to a method for treating a valvular annulus, comprising: fastening portions of two opposite leaflets; and applying energy to the valvular annulus adapted for shrinking at least a portion of the annulus tissue. In one embodiment, the steps of fastening portions of two opposite leaflets and applying energy are carried out percutaneously. In another embodiment, it is provided a method for fastening a portion of a first valve leaflet with a portion of a second valve leaflet in a patient, comprising steps of holding the portion of the first valve leaflet in contact with the portion of the second valve leaflet and applying a plurality of energy sources to securely fasten the two portions together.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0030]
    Additional objects and features of the present invention will become more apparent and the invention itself will be best understood from the following Detailed Description of the Exemplary Embodiments, when read with reference to the accompanying drawings.
  • [0031]
    FIG. 1 is a cutaway schematic of the heart showing the chambers and the spatial relationships of the various anatomical features discussed in the invention.
  • [0032]
    FIG. 2 is a cutaway schematic of the heart showing the relationships of the annulus to the leaflets and the relationship of the mitral valve to the aortic valve.
  • [0033]
    FIG. 3 is a top-down view of the mitral valve showing the annulus and the FIG. 4 is a top-down view of the tricuspid valve showing the annulus and the three leaflet tops.
  • [0034]
    FIG. 5A-5D is a four-part schematic drawing showing the steps in performing annuloplasty of the posterior leaflet and attaching an annuloplasty ring to the valve (prior art).
  • [0035]
    FIG. 6 is a schematic diagram of a guide catheter of the medical device according to the principles of the present invention.
  • [0036]
    FIG. 7 is a schematic diagram of a leaflet fastening applicator within the guide catheter according to one embodiment of the present invention.
  • [0037]
    FIG. 8 is a schematic diagram of the leaflet fastening applicator inserted inside the guide catheter as the device system of the present invention.
  • [0038]
    FIG. 9 is a schematic diagram of the leaflet fastening applicator retracted back inside the guide catheter as the device system of the present invention.
  • [0039]
    FIG. 10 is an enlarged schematic diagram of the distal end of a preferred embodiment of the leaflet fastening applicator.
  • [0040]
    FIG. 11 is a schematic illustration of the leaflet fastening applicator with grasping-electrodes grasping two valve leaflets.
  • [0041]
    FIG. 12 is a schematic illustration of the leaflet fastening applicator with grasping-electrodes grasping and holding the two valve leaflets together.
  • [0042]
    FIG. 13 is a detailed perspective view of the grasping-electrodes with a first hole on the first grasping-electrode and a second hole that is aligned with the first hole.
  • [0043]
    FIG. 14 is a detailed perspective view of the grasping-electrodes with a plurality of spikes on a first grasping-electrode and a plurality of recesses on a second grasping-electrode configured to engage the spikes of the first grasping-electrode.
  • [0044]
    FIG. 15 is a detailed perspective view of the grasping-electrodes with one clip button set having a notch on the first grasping-electrode and a lip on the second grasping-electrode.
  • [0045]
    FIG. 16 is an enlarged view of one embodiment of the invention, wherein the guide catheter is configured such that the distal opening provides access for securing a pair of the valve leaflets adapted for fastening the edges of leaflets with an energy welding method or a mechanical coupling method.
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0046]
    Referring to FIG. 1 through FIG. 16, what is shown is various views of the heart structures discussed and one embodiment of the present invention.
  • [0047]
    FIG. 1 shows a cut away schematic of the heart depicting the right atrium 74, left atrium 71, right ventricle 73, and left ventricle 72. The aorta 75 of the heart 70 connects with the left ventricle 72 and contains an aortic valve 76. Pulmonary artery 77 connects with the right ventricle 73 through a pulmonary valve. Left atrium 71 communicates with the left ventricle 72 through a mitral valve 79. The right atrium 74 communicates with the right ventricle 73 through a tricuspid valve. Oxygenated blood is returned to the heat 70 via pulmonary veins 88. In a perspective illustration, a device or catheter is inserted into the right atrium 74 and is positioned through the inner wall 51 and the annular structure 52 of the tricuspid valve leaflets 80. The leaflets 80 of the tricuspid valve open toward the ventricle side. Blood returned from the superior vena cava 84 and the inferior vena cava flows into the right atrium 74. Subsequently, blood flows from the right atrium 74 to the right ventricle 73 through the tricuspid valve. Therefore, the grasping-electrodes 12 of the catheter shaft 1 does not interfere with the leaflet movement during the proposed less invasive thermal fastening for the leaflets of the invention. The term “grasping-electrode” is meant to indicate herein an electrode having means for grasping/fastening an object and providing energy for intended use.
  • [0048]
    FIG. 2 shows a cutaway diagram of part of the heart, containing the mitral valve 79 and aortic valve 76 and showing the relationships between the annulus 91 and the leaflets 92 of the mitral valve 79. The circumflex artery 93 is located adjacent the mitral annulus 91.
  • [0049]
    FIG. 3 shows a top-down view of the mitral valve 91, looking through the left atrium 71. The relative positions of the anterior valve leaflet 94 and posterior valve leaflet 95 are shown, as are the antero-lateral commissure 96 and postero-medial commissure 97.
  • [0050]
    FIG. 4 shows a top-down view of the tricuspid valve 98, looking through the right atrium 74. The anterior valve leaflet 61, posterior valve leaflet 62 and septal valve leaflet 63 are shown, as are the three associated commissures.
  • [0051]
    For illustration purposes, FIG. 5A-5D shows a top-down view of a mitral valve 79 in various stages of repair, according to the current practices of open-heart surgery under cardiopulmonary bypass (prior art). View FIG. 5A shows the area AA of the posterior leaflet 95 to be resected in the valvuloplasty. View FIG. 5B shows the resected posterior leaflet 95B and placement of stay-sutures 99 in the annulus 91, drawing and tightening the annulus. View FIG. 5C shows the closed valvuloplasty and the tightening of the annulus 91 along a suture line 64 above the posterior leaflet. View FIG. 5D shows the placement of an annuloplasty ring 65, which secures the mitral valve annulus 91 in the desired shape and size. Note the difference between the shape and size achieved by the surgery in view FIG. 5D, compared to that in view FIG. 5A.
  • [0052]
    Williamson, IV et al. in U.S. Pat. No. 5,891,160 and No. 6,162,233 discloses wire fasteners having legs and lengths for use in minimally invasive surgery, entire contents of which are incorporated herein by reference. More particularly, it is disclosed that the fasteners are manipulated into position and then immobilized by the legs thereof for tensioning, cutting and forming in situ so as to secure the prosthesis to the patient. However, Williamson, IV et al. does not disclose a medical system having a fastening applicator that comprises a pair of grasping-electrodes means adapted for holding and engaging portions of opposing heart valve leaflets together and for applying suitable energy to fasten the portions.
  • [0053]
    Kuehn et al. in U.S. Pat. No. 6,165,183 discloses a method for performing an edge-to-edge fastening/securing of opposing heart valve leaflets through a catheter percutaneously. The catheter includes a leaflet fastener applicator with a gripper to hold the heart valve leaflets while they are fastened. The principles of “gripping/securing/fastening” arrangement and the mechanism as disclosed are incorporated herein by reference. However, Kuehn et al. does not disclose a medical system having a fastening applicator that comprises a pair of grasping-electrodes means adapted for holding and engaging portions of opposing heart valve leaflets together and for applying suitable energy to fasten the portions.
  • [0054]
    FIG. 6 shows a schematic of a guide catheter 11 comprising a catheter sheath 1 and at least a lumen 2. The catheter 11 further comprises a cap 3 on the handle 25 of the guide catheter 11 for closing the lumen 2 of the catheter during placement, a sideport 4 for injection of solutions into the catheter (e.g., radiographic contrast medium), a radiopaque band 6 at about the distal end 5 to locate the end during placement on fluoroscopy. The solution for injection through the sideport 4 or the lumen 2 may be selected from a group consisting of heparin, aspirin, saline, antibiotic solution, anti-inflammatory solution, anti-septic solution or the like.
  • [0055]
    FIG. 7 shows a schematic of a leaflet fastening applicator 7, which may contain a locking port 8 on the proximal end 9 and splits 15A, 15B in the applicator lumen 10 on the applicator distal end 13. The splits 15A, 15B can be configured in different shape, size and functional structures adapted for gripping, securing, fastening and/or coupling two pieces of tissue together. The proximal end 9 can be attached to a vacuum source for the applicator 7 to capture and secure the leaflets by way of vacuum. If the leaflets are to be secured by way of small hooks, individual cables attached to respective hooks are installed in the lumens of the leaflet holders. In another embodiment with energy transmission, the energy transmission route, such as electrical conductors 29, may be provided within the lumen 10 of the applicator 7. One end of the electrical conductor 29 is usually connected to an external energy generator or source.
  • [0056]
    FIG. 8 depicts the guide catheter in place, with the leaflet fastening applicator 7 contained within the guide catheter 11, wherein the splits 15A, 15B of the leaflet fastening applicator 7 extend out the distal end 5 of the guide catheter 11, such as these two splits may appear when attempting to capture and secure the leaflet(s) or other tissue. In one embodiment, the splits 15A, 15B may comprise a suction arrangement or other means for capturing the flexible leaflet and contain at their end portion a pair of grasping-electrodes for applying radiofrequency energy. The suction arrangement of the splits 15A, 15B may be accomplished by configuring the splits with an inner lumen connecting with an external suction source. In another embodiment, at least one of the splits 15A, 15B may contain at its end portion an ultrasound transducer, an optic fiber for laser or infrared transmission, or an element for electromagnetic energy transmission.
  • [0057]
    FIG. 9 depicts the guide catheter in place, with the leaflet fastening applicator 7 retracted within the guide catheter 11 and the ends of the leaflet fastening applicator 7 drawn slightly into the lumen 2 of the guide catheter 11.
  • [0058]
    In one embodiment, a device system of the present invention as shown in FIG. 10 comprises a guide catheter and a leaflet fastening applicator 7. As illustrated in FIGS. 8 and 9, the guide catheter has suitable dimensions for deployment and insertion into a human heart in a vicinity of a heart valve, wherein the leaflet fastening applicator 7 has a size allowing insertion through the guide catheter 11 and is capable of holding portions of opposing heart valve leaflets (as illustrated in FIG. 11 and FIG. 12). A typical guide catheter may range from about 1 mm in diameter to about 15 mm or larger in diameter. And the guide catheter can be made of any convenient biocompatible material, such as plastic or the like.
  • [0059]
    As shown in FIG. 10, the device system may further comprise at least a gripper 35 or 36 inside the applicator 7, the gripper having a suitable opening 29 for applying suction to one of the heart valve leaflets or tissue.
  • [0060]
    As shown in FIGS. 11 and 12, the fastening applicator 7 may optionally comprise a pair of grasping-electrodes 42A, 42B that is mounted at the distal end of the splits 15A, 15B, wherein the grasping-electrodes are configured and adapted for holding and engaging the portions 31, 32 of opposing heart valve leaflets 33, 34 together and for applying radiofrequency energy or other suitable energy to fasten the portions 31, 32. The radiofrequency energy may be introduced from an external radiofrequency source and passes from the first grasping-electrode 15A through the portions of opposing heart valve leaflets 31, 32 to the second grasping-electrode 15B. The device is equally applicable to a venous valve. The bi-polar radiofrequency arrangement and principles for tissue welding or fastening are well known to an ordinary artisan who is skilled in the art.
  • [0061]
    For illustration purposes as shown in FIG. 12, it is provided a non-ablative energy means 50 for shrinking at least a portion of the valvular annulus 52. One example of the non-ablative energy means is a deployable spiral wire electrode at a distal end of an elongate shaft 53 adapted to contact the tissue of the valvular annulus to be treated and to apply high frequency energy to the tissue for therapeutic purposes. A deployable spiral wire electrode is well known to one ordinary skill in the art and is disclosed in U.S. Pat. No. 6,267,781 that is co-invented by one of the current applicants. The energy for treating annulus tissue may be selected from a group consisting of radiofrequency, ultrasound, laser, microwave, electromagnetic, and combination thereof. The term “non-ablative” energy is herein intended to mean the energy sufficiently suitable to shrink or tighten collagen or tissue; however, the non-ablative energy is below the tissue ablation threshold that causes tissue injury or necrosis irreversibly.
  • [0062]
    For illustration purposes, another example of non-ablative energy means is a rotational electrode with sweeping force at the distal section of the tubular element to effect the heat treatment and the rotational sweeping massage therapy for target annulus tissues. A rotatable electrode is well known to one ordinary skill in the art and is disclosed in U.S. Pat. No. 6,283,962 that is co-invented by one of the current applicants. The energy for treating annulus tissue may be selected from a group consisting of radiofrequency, ultrasound, laser, microwave, electromagnetic, and combination thereof.
  • [0063]
    For illustration purposes, still another example of non-ablative energy means is an apparatus capable of sandwiching and compressing the annulus and applying heat sufficient to shrink or tighten tissue surrounding the annulus tissue. A sandwichable electrode is well known to one ordinary skill in the art and is disclosed in U.S. Pat. No. 6,485,489 that is co-invented by two of the current applicants. The energy for treating annulus tissue may be selected from a group consisting of radiofrequency, ultrasound, laser, microwave, electromagnetic, and combination thereof.
  • [0064]
    As shown in FIG. 13, the first grasping-electrode 42A of the present invention may comprise a first hole 44A and the second grasping-electrode 42B comprises a second hole 44B that is aligned with the first hole 44A, the first and second holes being adapted suitable for inserting a suture, a staple, a hook or other attachment device to fasten the portions of the opposing heart valve leaflets. The aligned holes are particularly suitable for any conventional types of tissue coupling and fastening. The exterior surfaces 43A, 43B of the non-contacting sides of the grasping-electrodes 42A, 42B in FIGS. 13 to 15 can be smooth surfaces or other appropriate arrangement.
  • [0065]
    In another embodiment as shown in FIG. 14, a first grasping-electrode 42A of the grasping-electrodes arrangement may comprise a plurality of spikes 45A and a second grasping-electrode 42B of the grasping-electrodes comprises a plurality of recesses 45B configured to engage the spikes 45A of the first grasping-electrode 42A, wherein the spikes' sharp ends of the first grasping-electrode pushes the body tissue into the recesses of the second grasping-electrode with enhanced grasping capability.
  • [0066]
    Scott et al. in U.S. Pat. No. 5,527,313 discloses a device wherein a first grasping-electrode has a plurality of spikes and a second grasping-electrode has a plurality of spikes configured to engage the spikes of the first grasping-electrode. Both jaws have a plurality of spikes and valleys in between the spikes. U.S. Pat. No. 5,527,313 further shows the two grasping-electrodes at an open position with the spikes' sharp ends of the first jaw facing the spikes' sharp ends of the second jaw whereas the two grasping electrodes at a closed position with the spikes' sharp ends of the first jaw falling into the valleys of the opposite spikes of the second jaw in a manner that does not push the body tissue into the recesses of the second grasping-electrode. And therefore, the prior art device does not have enhanced grasping capability.
  • [0067]
    In a further embodiment of FIG. 15, the pair of grasping-electrodes of the device system is configured to comprise at least one clip button set, wherein each of the at least one clip button set has a notch 46A on the first grasping-electrode 42A and a lip 46B on the second grasping-electrode 42B in which the notch 46A engages the lip 46B when the grasping-electrodes 42A, 42B are held close to each other for tissue fastening purposes.
  • [0068]
    In a preferred embodiment as shown in FIG. 16, the device system of the present invention may further comprise a tubular gripper 27 having a distal end 38 and a lumen 39, the tubular gripper 37 having a suitable opening 40 at its distal end 38 for applying suction to grip at least two of the target heart valve leaflets 33, 34 to enter the lumen 39 adapted for fastening the portions of opposing heart valve leaflets together using a mechanical fastening method or energy fastening method. In an alternate embodiment, a plurality of suction tubular elements 47, 48 is positioned within the lumen 39 of the tubular gripper 37. The adjacent leaflet edges are held in place within elements 47, 48 with constant vacuum. In this position, the cardiologist can evaluate the effects of attaching the leaflets, by examining the flow of contrast medium or examining flow with ultrasound, during the beating of the heart and the flow and ebb of blood at the valve. An ultrasonic imaging system may be incorporated during the procedure to assist the cardiologist. The fastening means may comprise energy welding or mechanical fastening.
  • [0069]
    Some aspects of the invention relate to a device system for treating a valvular annulus comprising a guide catheter and a leaflet fastening applicator, the guide catheter having suitable dimensions for deployment and insertion into a human heart in a vicinity of a heart valve and comprising a non-ablative energy means for shrinking at least a portion of the valvular annulus, the leaflet fastening applicator having a size allowing insertion through the guide catheter and being capable of holding portions of opposing heart valve leaflets, wherein the fastening applicator comprises a pair of grasping-electrodes adapted for holding and engaging the portions of opposing heart valve leaflets together and for applying radiofrequency energy to fasten the portions, wherein a first of the grasping-electrodes comprises a plurality of spikes and a second of the grasping-electrodes comprises a plurality of recesses configured to receivably match and engage the spikes of the first grasping-electrode, wherein the catheter comprises at least a gripper inside the catheter, the gripper having a suitable opening sized and configured for applying vacuum suction to releasably grip one of the heart valve leaflets. The non-ablative energy means may be selected from a group consisting of radiofrequency energy, ultrasound energy, laser energy, electromagnetic energy, microwave energy and the like.
  • [0070]
    One mode of performing the method of the present invention is to have a catheter introduced via aortic valve or more commonly across atrial septum as in balloon valvuloplasty of the mitral valve. After entrapment of leaflets, a stapling device is pushed to site where anterior and posterior leaflets approximate each other. The staple, suture or other attachment device is guided to approximate leaflets and pulled back to ensure both leaflets are caught and then released. This stapling step may optionally be added to the energy-assisted leaflets welding/fastening disclosure of the present invention with at least one energy source, wherein the energy source is selected from a group consisting of radiofrequency energy, ultrasound energy, laser energy, electromagnetic energy, cryogenic energy, microwave energy and the like.
  • [0071]
    In some preferred aspects, it is provided a method for treating a valvular annulus, comprising: (a) fastening portions of two opposite leaflets; and (b) applying energy to the valvular annulus adapted for shrinking at least a portion of the annulus tissue. In one embodiment, the steps of fastening portions of two opposite leaflets and applying energy are carried out percutaneously. In another embodiment, the steps of fastening portions of two opposite leaflets and applying energy are carried out through an open chest procedure. In still another embodiment, the energy for shrinking at least a portion of the annulus tissue is selected from a group consisting of radiofrequency energy, ultrasound energy, electromagnetic energy, microwave energy, laser energy, and cryogenic energy.
  • [0072]
    Although the explanations and illustration herein have used the mitral valve as an example, the devices in either embodiment can be used on mitral, tricuspid, aortic or pulmonary valves as indicated for the improvement in leaflet coaptation and valve competence, during normal heart/blood cycling, without the need for costly, risky and painful open-heart surgery and cardiopulmonary bypass. This invention is not a complete replacement for the repair offered by cardiothoracic surgeons in repair of these heart valves. Practically, there are certain cases, which can be aided only through open-heart procedures. However, this invention should serve a significant segment of the population, who will be assisted with the type of repairs offered by these methods and devices.
  • [0073]
    U.S. Pat. No. 6,267,781, co-invented by one of the current applicants, teaches anon-ablative energy treating device for treating valvular annulus or valvular organ structure of a patient, comprising a flexible elongate tubular shaft having a deployable spiral wire electrode at its distal end adapted to contact/penetrate the tissue to be treated and to apply high frequency energy to the tissue for therapeutic purposes. U.S. Pat. No. 6,283,962, co-invented by one of the current applicants, discloses a medical energy device system for treating valvular annulus wherein an elongate tubular element comprises an electrode disposed at its distal section that is extendible from an opening at one side of the tubular element, the energy generator, and means for generating rotational sweeping force at the distal section of the tubular element to effect the heat treatment and the rotational sweeping massage therapy for target tissues. Both patents, entire contents of which are incorporated herein by reference, teach the local tissue shrinkage, not for simultaneously fastening portions of two opposite valve leaflets together to enhance annulus repairing and function.
  • [0074]
    U.S. Pat. No. 6,306,133, co-invented by one applicant of the present invention, entire contents of which are incorporated herein by reference, discloses a non-ablative energy catheter system and methods for repairing an annular organ structure comprising high frequency non-ablative energy for the purposes of tightening and stabilizing a tissue. A catheter suitable for high frequency energy delivery comprises a flexible tissue-contactor means located at the distal tip section of a catheter shaft for contacting an inner wall of the annular organ structure, and a needle electrode means located at or within the flexible tissue-contactor means for penetrating into the tissue, wherein the needle electrode means is deployable out of the tissue-contactor means in a manner essentially perpendicular to a longitudinal axis of the catheter shaft.
  • [0075]
    U.S. Pat. No. 6,485,489, co-invented by two applicants of the present invention, entire contents of which are incorporated herein by reference, discloses a catheter system and methods for repairing a valvular annulus of a patient comprising sandwiching and compressing the annulus and applying heat sufficient to shrink or tighten tissue surrounding the annulus defect. Some aspects of the invention relate to simultaneously fastening the leaflets together and applying energy effective to shrink or tighten annulus tissue for annulus repairing.
  • [0076]
    From the foregoing description, it should now be appreciated that an energy-assisted tissue fastening approach percutaneously for valve leaflets fastening has been disclosed. While the invention has been described with reference to a specific embodiment, the description is illustrative of the invention and is not to be construed as limiting the invention. Various modifications and applications may occur to those who are skilled in the art, without departing from the true spirit and scope of the invention, as described by the appended claims.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3378010 *Jul 28, 1965Apr 16, 1968ColdlingSurgical clip with means for releasing the clamping pressure
US5047041 *Mar 23, 1990Sep 10, 1991Samuels Peter BSurgical apparatus for the excision of vein valves in situ
US5226911 *Oct 2, 1991Jul 13, 1993Target TherapeuticsVasoocclusion coil with attached fibrous element(s)
US5234437 *Dec 12, 1991Aug 10, 1993Target Therapeutics, Inc.Detachable pusher-vasoocclusion coil assembly with threaded coupling
US5312415 *Sep 22, 1992May 17, 1994Target Therapeutics, Inc.Assembly for placement of embolic coils using frictional placement
US5312424 *Jul 24, 1992May 17, 1994Keravision, Inc.Conreal curvature adjustment ring
US5403312 *Jul 22, 1993Apr 4, 1995Ethicon, Inc.Electrosurgical hemostatic device
US5527313 *Apr 6, 1995Jun 18, 1996United States Surgical CorporationBipolar surgical instruments
US5609598 *Dec 30, 1994Mar 11, 1997Vnus Medical Technologies, Inc.Method and apparatus for minimally invasive treatment of chronic venous insufficiency
US5640955 *Feb 14, 1995Jun 24, 1997Daig CorporationGuiding introducers for use in the treatment of accessory pathways around the mitral valve using a retrograde approach
US5716367 *Oct 18, 1996Feb 10, 1998Nissho CorporationCatheter assembly for intracardiac suture
US5719725 *Dec 2, 1996Feb 17, 1998Sanyo Electric Co., Ltd.Disk playback device
US5741280 *Nov 13, 1995Apr 21, 1998Coral MedicalKnot tying method and apparatus
US5891160 *Dec 4, 1997Apr 6, 1999Cardiovascular Technologies, LlcFastener delivery and deployment mechanism and method for placing the fastener in minimally invasive surgery
US5916147 *Sep 22, 1997Jun 29, 1999Boury; Harb N.Selectively manipulable catheter
US5928224 *Jan 24, 1997Jul 27, 1999Hearten Medical, Inc.Device for the treatment of damaged heart valve leaflets and methods of using the device
US6068628 *Aug 20, 1996May 30, 2000Oratec Interventions, Inc.Apparatus for treating chondromalacia
US6068629 *Dec 15, 1998May 30, 2000Medtronic, Inc.System and methods for tissue mapping and ablation
US6077214 *Jul 29, 1998Jun 20, 2000Myocor, Inc.Stress reduction apparatus and method
US6187003 *Nov 12, 1997Feb 13, 2001Sherwood Services AgBipolar electrosurgical instrument for sealing vessels
US6190408 *Mar 5, 1998Feb 20, 2001The University Of CincinnatiDevice and method for restructuring the heart chamber geometry
US6203553 *Sep 8, 1999Mar 20, 2001United States SurgicalStapling apparatus and method for heart valve replacement
US6269819 *Jun 25, 1998Aug 7, 2001The Trustees Of Columbia University In The City Of New YorkMethod and apparatus for circulatory valve repair
US6402781 *Jan 31, 2000Jun 11, 2002MitralifePercutaneous mitral annuloplasty and cardiac reinforcement
US6406420 *Oct 21, 1999Jun 18, 2002Myocor, Inc.Methods and devices for improving cardiac function in hearts
US6537314 *Jan 30, 2001Mar 25, 2003Ev3 Santa Rosa, Inc.Percutaneous mitral annuloplasty and cardiac reinforcement
US6562037 *Feb 12, 1998May 13, 2003Boris E. PatonBonding of soft biological tissues by passing high frequency electric current therethrough
US6585761 *Mar 1, 2001Jul 1, 2003Syde A. TaheriProsthetic vein valve and method
US6689184 *Jul 19, 2002Feb 10, 2004Latitude Manufacturing Technologies, Inc.Iron-based powdered metal compositions
US6690671 *Aug 17, 1998Feb 10, 2004Marconi Communications, Inc.Load balanced UBR routing in ATM networks
US6701929 *Mar 27, 2001Mar 9, 2004Hany HusseinDevice and method for treatment of congestive heart failure
US6702826 *Jun 22, 2001Mar 9, 2004Viacor, Inc.Automated annular plication for mitral valve repair
US6709382 *May 3, 2000Mar 23, 2004Simon Marcus HornerCardiac assist method and apparatus
US6709456 *Oct 1, 2001Mar 23, 2004Ev3 Santa Rosa, Inc.Percutaneous mitral annuloplasty with hemodynamic monitoring
US6723038 *Oct 6, 2000Apr 20, 2004Myocor, Inc.Methods and devices for improving mitral valve function
US6728718 *Jun 26, 2001Apr 27, 2004International Business Machines CorporationMethod and system for recovering DHCP data
US6740107 *Dec 19, 2001May 25, 2004Trimedyne, Inc.Device for treatment of atrioventricular valve regurgitation
US6746471 *May 25, 2001Jun 8, 2004Myocor, Inc.Transventricular implant tools and devices
US6755777 *Dec 20, 2002Jun 29, 2004Myocor, Inc.Heart wall tension reduction apparatus and method
US6764510 *Jan 9, 2002Jul 20, 2004Myocor, Inc.Devices and methods for heart valve treatment
US6770083 *Jul 24, 2002Aug 3, 2004Evalve, Inc.Surgical device for connecting soft tissue
US6875224 *Oct 17, 2001Apr 5, 2005Massachusetts General HospitalDevices and methods for percutaneous mitral valve repair
US20020013571 *Jun 27, 2001Jan 31, 2002Evalve, Inc.Methods and devices for capturing and fixing leaflets in valve repair
US20020035361 *Jul 3, 2001Mar 21, 2002Houser Russell A.Apparatus and methods for treating tissue
US20020087148 *Nov 16, 2001Jul 4, 2002Brock David L.Flexible instrument
US20020087169 *Nov 16, 2001Jul 4, 2002Brock David L.Flexible instrument
US20030050693 *Sep 10, 2001Mar 13, 2003Quijano Rodolfo C.Minimally invasive delivery system for annuloplasty rings
US20030069570 *Nov 12, 2002Apr 10, 2003Witzel Thomas H.Methods for repairing mitral valve annulus percutaneously
US20030069636 *Nov 26, 2002Apr 10, 2003Solem Jan OttoMethod for treatment of mitral insufficiency
US20030069693 *Aug 28, 2002Apr 10, 2003Snapp Douglas N.Geographic pointing device
US20030074012 *Apr 10, 2002Apr 17, 2003Coalescent Surgical, Inc.Minimally invasive annuloplasty procedure and apparatus
US20030078654 *Aug 14, 2002Apr 24, 2003Taylor Daniel C.Method and apparatus for improving mitral valve function
US20030083742 *Oct 9, 2002May 1, 2003Paul A. SpenceHeart valve repair apparatus and methods
US20030120341 *Dec 21, 2001Jun 26, 2003Hani ShennibDevices and methods of repairing cardiac valves
US20030130730 *Oct 25, 2002Jul 10, 2003Cohn William E.Method and apparatus for reducing mitral regurgitation
US20040003819 *Jul 3, 2003Jan 8, 2004Evalve, Inc.Methods and apparatus for cardiac valve repair
US20040019377 *Jan 14, 2003Jan 29, 2004Taylor Daniel C.Method and apparatus for reducing mitral regurgitation
US20040019378 *Jul 18, 2003Jan 29, 2004Hlavka Edwin J.Method and apparatus for performing catheter-based annuloplasty
US20040024414 *Jul 1, 2003Feb 5, 2004Downing Stephen W.Apparatuses and methods for performing minimally invasive diagnostic and surgical procedures inside of a beating heart
US20040030382 *Aug 5, 2003Feb 12, 2004Evalve, Inc.Methods and apparatus for cardiac valve repair
US20040039443 *Dec 24, 2002Feb 26, 2004Solem Jan OttoMethod and device for treatment of mitral insufficiency
US20040044350 *May 19, 2003Mar 4, 2004Evalve, Inc.Steerable access sheath and methods of use
US20040049211 *Jun 12, 2003Mar 11, 2004Mitral Interventions, Inc.Method and apparatus for tissue connection
US20040073302 *May 27, 2003Apr 15, 2004Jonathan RourkeMethod and apparatus for improving mitral valve function
US20040088047 *Oct 28, 2003May 6, 2004Paul A. SpenceHeart valve repair apparatus and methods
US20040089442 *Jun 27, 2003May 13, 2004The Board Of Trustees Of The Leland Stanford Junior UniversityElectroosmotic microchannel cooling system
US20040097979 *Nov 14, 2002May 20, 2004Oleg SvanidzeAortic valve implantation device
US20040106989 *Jul 3, 2003Jun 3, 2004Wilson Robert F.Leaflet reinforcement for regurgitant valves
US20040111099 *Nov 19, 2003Jun 10, 2004Coalescent Surgical, Inc.Minimally invasive valve repair procedure and apparatus
US20040122448 *Aug 13, 2003Jun 24, 2004The General Hospital CorporationCardiac devices and methods for percutaneous repair of atrioventricular valves
US20040127981 *Oct 1, 2003Jul 1, 2004Ample Medical, Inc.Devices, systems, and methods for retaining a native heart valve leaflet
US20040127982 *Oct 1, 2003Jul 1, 2004Ample Medical, Inc.Devices, systems, and methods for reshaping a heart valve annulus
US20040127983 *Oct 7, 2003Jul 1, 2004Myocor, Inc.Valve to myocardium tension members device and method
US20040133062 *Oct 8, 2003Jul 8, 2004Suresh PaiMinimally invasive cardiac force transfer structures
US20040133063 *Dec 12, 2003Jul 8, 2004MyocorMethods and devices for improving cardiac function in hearts
US20040133192 *Sep 23, 2003Jul 8, 2004Houser Russell A.Apparatus and methods for treating tissue
US20040133220 *Aug 5, 2003Jul 8, 2004Randall LashinskiAdjustable transluminal annuloplasty system
US20040133240 *Jan 7, 2003Jul 8, 2004Cardiac Dimensions, Inc.Electrotherapy system, device, and method for treatment of cardiac valve dysfunction
US20040133273 *Dec 17, 2003Jul 8, 2004Cox Daniel L.Apparatuses and methods for heart valve repair
US20040138744 *Aug 5, 2003Jul 15, 2004Randall LashinskiTransluminal mitral annuloplasty with active anchoring
US20040138745 *Oct 28, 2003Jul 15, 2004Ample Medical, Inc.Methods and devices for heart valve treatments
US20040148021 *Aug 29, 2003Jul 29, 2004Cartledge Richard G.Implantable devices for controlling the internal circumference of an anatomic orifice or lumen
US20040152947 *Jan 23, 2004Aug 5, 2004Schroeder Richard F.Methods and devices for improving mitral valve function
US20040153144 *Jan 23, 2004Aug 5, 2004Jacques SeguinAnnuloplasty device for use in minimally invasive procedure
US20040158123 *Feb 2, 2004Aug 12, 2004Swaminathan JayaramanModification of properties and geometry of heart tissue to influence function
US20040167539 *Feb 23, 2004Aug 26, 2004St. Jude Medical, Inc.Mitral and tricuspid valve repair
US20050004583 *Jun 30, 2004Jan 6, 2005Oz Mehmet C.Method and apparatus for circulatory valve repair
US20050004668 *Jul 2, 2004Jan 6, 2005Flexcor, Inc.Annuloplasty rings and methods for repairing cardiac valves
US20050021056 *Aug 25, 2004Jan 27, 2005Evalve, Inc.Leaflet structuring
US20050021057 *Aug 25, 2004Jan 27, 2005Evalve, Inc.Leaflet structuring
US20050033446 *Apr 7, 2004Feb 10, 2005Evalve, Inc. A California CorporationMethods and apparatus for cardiac valve repair
US20050038508 *Aug 13, 2003Feb 17, 2005Shlomo GabbayImplantable cardiac prosthesis for mitigating prolapse of a heart valve
US20050049698 *Oct 18, 2004Mar 3, 2005Bolling Steven F.Methods of implanting a mitral valve annuloplasty ring to correct mitral regurgitation
US20050055089 *Jul 19, 2004Mar 10, 2005Ample Medical, Inc.Devices, systems, and methods for reshaping a heart valve annulus
US20050059351 *Oct 29, 2004Mar 17, 2005Patrick CauwelsUser-specified outputs in mobile wireless communication devices and methods therefor
US20050159810 *Jan 15, 2004Jul 21, 2005Farzan FilsoufiDevices and methods for repairing cardiac valves
US20060058871 *Sep 14, 2005Mar 16, 2006Edwards Lifesciences, AgDevice and method for treatment of heart valve regurgitation
US20060195012 *Apr 14, 2006Aug 31, 2006Myocor, Inc.Valve to myocardium tension members device and method
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7526337Jun 6, 2006Apr 28, 2009Cardiac Pacemakers, Inc.Method and device for lymphatic system monitoring
US7655015Dec 21, 2007Feb 2, 2010Evalve, Inc.Fixation devices, systems and methods for engaging tissue
US7666204May 19, 2003Feb 23, 2010Evalve, Inc.Multi-catheter steerable guiding system and methods of use
US7670368Feb 7, 2005Mar 2, 2010Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US7682319Feb 25, 2009Mar 23, 2010Evalve, Inc.Steerable access sheath and methods of use
US7682369Feb 14, 2006Mar 23, 2010Evalve, Inc.Surgical device for connecting soft tissue
US7682385Jul 3, 2006Mar 23, 2010Boston Scientific CorporationArtificial valve
US7704269Aug 5, 2003Apr 27, 2010Evalve, Inc.Methods and apparatus for cardiac valve repair
US7722666Apr 15, 2005May 25, 2010Boston Scientific Scimed, Inc.Valve apparatus, system and method
US7734341Jun 6, 2006Jun 8, 2010Cardiac Pacemakers, Inc.Method and apparatus for gastrointestinal stimulation via the lymphatic system
US7736388Jan 16, 2007Jun 15, 2010Evalve, Inc.Fixation devices, systems and methods for engaging tissue
US7749249May 19, 2006Jul 6, 2010Kardium Inc.Method and device for closing holes in tissue
US7753923Aug 25, 2004Jul 13, 2010Evalve, Inc.Leaflet suturing
US7758596Oct 15, 2002Jul 20, 2010The Trustees Of Columbia University In The City Of New YorkMethod and apparatus for circulatory valve repair
US7761157Feb 16, 2007Jul 20, 2010Cardiac Pacemakers, Inc.Cardiac stimulation and sensing with endolymphatically implanted lead
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
US7799038Jan 20, 2006Sep 21, 2010Boston Scientific Scimed, Inc.Translumenal apparatus, system, and method
US7811296Oct 27, 2004Oct 12, 2010Evalve, Inc.Fixation devices for variation in engagement of tissue
US7837610Aug 2, 2006Nov 23, 2010Kardium Inc.System for improving diastolic dysfunction
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
US7878966Feb 4, 2005Feb 1, 2011Boston Scientific Scimed, Inc.Ventricular assist and support device
US7892276Dec 21, 2007Feb 22, 2011Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US7894906Jun 6, 2006Feb 22, 2011Cardiac Pacemakers, Inc.Amelioration of chronic pain by endolymphatic stimulation
US7938827Mar 10, 2009May 10, 2011Evalva, Inc.Cardiac valve leaflet attachment device and methods thereof
US7951189Jul 27, 2009May 31, 2011Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US7967853Feb 5, 2008Jun 28, 2011Boston Scientific Scimed, Inc.Percutaneous valve, system and method
US7981123Feb 3, 2010Jul 19, 2011Evalve, Inc.Surgical device for connecting soft tissue
US7998151Aug 25, 2004Aug 16, 2011Evalve, Inc.Leaflet suturing
US8002824Jul 23, 2009Aug 23, 2011Boston Scientific Scimed, Inc.Cardiac valve, system, and method
US8012198Jun 10, 2005Sep 6, 2011Boston Scientific Scimed, Inc.Venous valve, system, and method
US8029518Oct 30, 2007Oct 4, 2011Evalve, Inc.Methods and devices for capturing and fixing leaflets in valve repair
US8052592Oct 7, 2009Nov 8, 2011Evalve, Inc.Methods and devices for tissue grasping and assessment
US8057493Dec 18, 2009Nov 15, 2011Evalve, Inc.Fixation devices, systems and methods for engaging tissue
US8123703Feb 3, 2010Feb 28, 2012Evalve, Inc.Steerable access sheath and methods of use
US8126538 *Jun 6, 2006Feb 28, 2012Cardiac Pacemakers, Inc.Method and apparatus for introducing endolymphatic instrumentation
US8128681Dec 19, 2003Mar 6, 2012Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US8133270Jan 8, 2008Mar 13, 2012California Institute Of TechnologyIn-situ formation of a valve
US8137394Jan 14, 2011Mar 20, 2012Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US8142493Jul 22, 2008Mar 27, 2012Mitralign, Inc.Method of heart valve repair
US8150499Nov 19, 2010Apr 3, 2012Kardium Inc.Automatic atherectomy system
US8187299Oct 29, 2007May 29, 2012Evalve, Inc.Methods and apparatus for cardiac valve repair
US8197464Dec 22, 2008Jun 12, 2012Cordis CorporationDeflecting guide catheter for use in a minimally invasive medical procedure for the treatment of mitral valve regurgitation
US8216230Apr 4, 2011Jul 10, 2012Evalve, Inc.Cardiac valve leaflet attachment device and methods thereof
US8216256Feb 26, 2009Jul 10, 2012Evalve, Inc.Detachment mechanism for implantable fixation devices
US8226709Oct 10, 2008Jul 24, 2012Cordis CorporationMethod and system for plicating tissue in a minimally invasive medical procedure for the treatment of mitral valve regurgitation
US8323334Jan 28, 2009Dec 4, 2012Evalve, Inc.Methods and apparatus for cardiac valve repair
US8337524May 11, 2010Dec 25, 2012Kardium Inc.Method and device for closing holes in tissue
US8343174Sep 4, 2009Jan 1, 2013Evalve, Inc.Locking mechanisms for fixation devices and methods of engaging tissue
US8348999Feb 13, 2012Jan 8, 2013California Institute Of TechnologyIn-situ formation of a valve
US8369943Oct 22, 2009Feb 5, 2013Cardiac Pacemakers, Inc.Method and apparatus for neural stimulation via the lymphatic system
US8382829Mar 9, 2009Feb 26, 2013Mitralign, Inc.Method to reduce mitral regurgitation by cinching the commissure of the mitral valve
US8409273Oct 30, 2007Apr 2, 2013Abbott Vascular IncMulti-catheter steerable guiding system and methods of use
US8414641Mar 2, 2012Apr 9, 2013Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US8449605Jun 28, 2006May 28, 2013Kardium Inc.Method for anchoring a mitral valve
US8460365May 27, 2011Jun 11, 2013Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US8460371Oct 21, 2003Jun 11, 2013Mitralign, Inc.Method and apparatus for performing catheter-based annuloplasty using local plications
US8465500Jan 19, 2006Jun 18, 2013Mayo Foundation For Medical Education And ResearchThorascopic heart valve repair method and apparatus
US8470023Jun 22, 2011Jun 25, 2013Boston Scientific Scimed, Inc.Percutaneous valve, system, and method
US8470028Jan 19, 2010Jun 25, 2013Evalve, Inc.Methods, systems and devices for cardiac valve repair
US8489172Jan 25, 2008Jul 16, 2013Kardium Inc.Liposuction system
US8500761Dec 11, 2009Aug 6, 2013Abbott VascularFixation devices, systems and methods for engaging tissue
US8512399Dec 28, 2009Aug 20, 2013Boston Scientific Scimed, Inc.Valve apparatus, system and method
US8532746Feb 24, 2012Sep 10, 2013Kardium Inc.Automatic atherectomy system
US8672997Apr 24, 2012Mar 18, 2014Boston Scientific Scimed, Inc.Valve with sinus
US8672998Apr 29, 2013Mar 18, 2014Kardium Inc.Method for anchoring a mitral valve
US8721717Jan 27, 2012May 13, 2014Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US8734505Sep 24, 2009May 27, 2014Evalve, Inc.Methods and apparatus for cardiac valve repair
US8740918Jun 9, 2011Jun 3, 2014Evalve, Inc.Surgical device for connecting soft tissue
US8740920May 22, 2013Jun 3, 2014Evalve, Inc.Fixation devices, systems and methods for engaging tissue
US8758393Oct 20, 2008Jun 24, 2014Neochord, Inc.Minimally invasive repair of a valve leaflet in a beating heart
US8828079Jul 26, 2007Sep 9, 2014Boston Scientific Scimed, Inc.Circulatory valve, system and method
US8845723Mar 13, 2007Sep 30, 2014Mitralign, Inc.Systems and methods for introducing elements into tissue
US8864822Mar 13, 2007Oct 21, 2014Mitralign, Inc.Devices and methods for introducing elements into tissue
US8888791May 7, 2009Nov 18, 2014Kardium Inc.Surgical instrument and method for tensioning and securing a flexible suture
US8897878May 6, 2010Nov 25, 2014Cardiac Pacemakers, Inc.Method and apparatus for gastrointestinal stimulation via the lymphatic system
US8905999Sep 1, 2006Dec 9, 2014Cardiac Pacemakers, Inc.Method and apparatus for endolymphatic drug delivery
US8906011Nov 16, 2007Dec 9, 2014Kardium Inc.Medical device for use in bodily lumens, for example an atrium
US8911461Nov 5, 2007Dec 16, 2014Mitralign, Inc.Suture cutter and method of cutting suture
US8920411Jun 28, 2006Dec 30, 2014Kardium Inc.Apparatus and method for intra-cardiac mapping and ablation
US8932287Mar 23, 2011Jan 13, 2015Kardium Inc.Medical device for use in bodily lumens, for example an atrium
US8932349Aug 22, 2011Jan 13, 2015Boston Scientific Scimed, Inc.Cardiac valve, system, and method
US8940002Sep 28, 2011Jan 27, 2015Kardium Inc.Tissue anchor system
US8951285Jul 5, 2005Feb 10, 2015Mitralign, Inc.Tissue anchor, anchoring system and methods of using the same
US8951286Nov 19, 2008Feb 10, 2015Mitralign, Inc.Tissue anchor and anchoring system
US8968338Feb 19, 2010Mar 3, 2015Mayo Foundation For Medical Education And ResearchThorascopic heart valve repair method and apparatus
US8979923Sep 24, 2004Mar 17, 2015Mitralign, Inc.Tissue fastening systems and methods utilizing magnetic guidance
US9011423Mar 11, 2013Apr 21, 2015Kardium, Inc.Systems and methods for selecting, activating, or selecting and activating transducers
US9017320Mar 11, 2013Apr 28, 2015Kardium, Inc.Systems and methods for activating transducers
US9017321Mar 11, 2013Apr 28, 2015Kardium, Inc.Systems and methods for activating transducers
US9023058Oct 7, 2008May 5, 2015Kardium Inc.Surgical instrument and method for tensioning and securing a flexible suture
US9028542Sep 6, 2011May 12, 2015Boston Scientific Scimed, Inc.Venous valve, system, and method
US9037244Feb 13, 2008May 19, 2015Virender K. SharmaMethod and apparatus for electrical stimulation of the pancreatico-biliary system
US9044221Dec 29, 2011Jun 2, 2015Neochord, Inc.Exchangeable system for minimally invasive beating heart repair of heart valve leaflets
US9044246Aug 24, 2011Jun 2, 2015Abbott Vascular Inc.Methods and devices for capturing and fixing leaflets in valve repair
US9050066May 20, 2011Jun 9, 2015Kardium Inc.Closing openings in anatomical tissue
US9060858May 28, 2013Jun 23, 2015Evalve, Inc.Methods, systems and devices for cardiac valve repair
US9072511Mar 15, 2012Jul 7, 2015Kardium Inc.Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve
US9119633Mar 5, 2013Sep 1, 2015Kardium Inc.Apparatus and method for intra-cardiac mapping and ablation
US9119634Nov 18, 2014Sep 1, 2015Kardium Inc.Apparatus and method for intra-cardiac mapping and ablation
US9192374Oct 20, 2008Nov 24, 2015Neochord, Inc.Minimally invasive repair of a valve leaflet in a beating heart
US9192468Jan 23, 2014Nov 24, 2015Kardium Inc.Method for anchoring a mitral valve
US9198592Nov 18, 2014Dec 1, 2015Kardium Inc.Systems and methods for activating transducers
US9204964Jun 13, 2013Dec 8, 2015Kardium Inc.Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve
US9259218Feb 26, 2013Feb 16, 2016Mitralign, Inc.Tissue anchor and anchoring system
US9259264Apr 14, 2015Feb 16, 2016Kardium Inc.Systems and methods for activating transducers
US9301843Nov 10, 2010Apr 5, 2016Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US9358111Aug 27, 2013Jun 7, 2016Mitralign, Inc.Tissue anchors, systems and methods, and devices
US9358112Dec 19, 2013Jun 7, 2016Mitralign, Inc.Method and apparatus for catheter-based annuloplasty using local plications
US9364213May 21, 2013Jun 14, 2016Mayo Foundation For Medical Education And ResearchThorascopic heart valve repair method
US9364326Jun 21, 2012Jun 14, 2016Mitralix Ltd.Heart valve repair devices and methods
US9370419Nov 30, 2010Jun 21, 2016Boston Scientific Scimed, Inc.Valve apparatus, system and method
US9370424Feb 19, 2013Jun 21, 2016Mitralign, Inc.Method to reduce mitral regurgitation by cinching the commissure of the mitral valve
US9421083Jun 24, 2013Aug 23, 2016Boston Scientific Scimed Inc.Percutaneous valve, system and method
US9439713Apr 14, 2015Sep 13, 2016Kardium Inc.Systems and methods for activating transducers
US9445862Apr 14, 2015Sep 20, 2016Kardium Inc.Systems and methods for selecting, activating, or selecting and activating transducers
US9452016Dec 20, 2013Sep 27, 2016Kardium Inc.Catheter system
US9474609Oct 7, 2015Oct 25, 2016Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US9480525Mar 11, 2013Nov 1, 2016Kardium, Inc.High-density electrode-based medical device system
US9486273Mar 11, 2013Nov 8, 2016Kardium Inc.High-density electrode-based medical device system
US9492227Mar 1, 2013Nov 15, 2016Kardium Inc.Enhanced medical device for use in bodily cavities, for example an atrium
US9492228Mar 1, 2013Nov 15, 2016Kardium Inc.Enhanced medical device for use in bodily cavities, for example an atrium
US9510829Apr 23, 2014Dec 6, 2016Evalve, Inc.Fixation devices, systems and methods for engaging tissue
US9510837Apr 23, 2014Dec 6, 2016Evalve, Inc.Surgical device for connecting soft tissue
US9526573Mar 1, 2013Dec 27, 2016Kardium Inc.Enhanced medical device for use in bodily cavities, for example an atrium
US9532831Jan 19, 2016Jan 3, 2017Kardium Inc.Systems and methods for activating transducers
US9572509Nov 23, 2015Feb 21, 2017Kardium Inc.Systems and methods for activating transducers
US9572557Oct 15, 2012Feb 21, 2017Kardium Inc.Method and device for closing holes in tissue
US9585717Mar 28, 2014Mar 7, 2017Kardium Inc.Medical device for use in bodily lumens, for example an atrium
US20030201519 *Apr 10, 2003Oct 30, 2003Lamson Michael A.Semiconductor package with conductor impedance selected during assembly
US20040002719 *Oct 15, 2002Jan 1, 2004Oz Mehmet C.Method and apparatus for circulatory valve repair
US20040199183 *Apr 28, 2004Oct 7, 2004Oz Mehmet C.Method and apparatus for circulatory valve repair
US20050033446 *Apr 7, 2004Feb 10, 2005Evalve, Inc. A California CorporationMethods and apparatus for cardiac valve repair
US20050184122 *Apr 21, 2005Aug 25, 2005Mitralign, Inc.Method and apparatus for performing catheter-based annuloplasty using local plications
US20060184242 *Apr 10, 2006Aug 17, 2006Samuel LichtensteinMethod and apparatus for percutaneous reduction of anterior-posterior diameter of mitral valve
US20070282376 *Jun 6, 2006Dec 6, 2007Shuros Allan CMethod and apparatus for neural stimulation via the lymphatic system
US20070282380 *Feb 16, 2007Dec 6, 2007Cardiac PacemakersCardiac stimulation and sensing with endolymphatically implanted lead
US20070282382 *Jun 6, 2006Dec 6, 2007Shuros Allan CMethod and device for lymphatic system monitoring
US20070282386 *Jun 6, 2006Dec 6, 2007Shuros Allan CMethod and apparatus for gastrointestinal stimulation via the lymphatic system
US20070282390 *Jun 6, 2006Dec 6, 2007Shuros Allan CAmelioration of chronic pain by endolymphatic stimulation
US20080009719 *Jun 6, 2006Jan 10, 2008Shuros Allan CMethod and apparatus for introducing endolymphatic instrumentation
US20080097412 *Sep 1, 2006Apr 24, 2008Shuros Allan CMethod and apparatus for endolymphatic drug delivery
US20080195171 *Feb 13, 2008Aug 14, 2008Sharma Virender KMethod and Apparatus for Electrical Stimulation of the Pancreatico-Biliary System
US20080228266 *Mar 13, 2007Sep 18, 2008Mitralign, Inc.Plication assistance devices and methods
US20080275503 *Jul 22, 2008Nov 6, 2008Mitralign, Inc.Method of heart valve repair
US20090053980 *Aug 21, 2008Feb 26, 2009Saint-Gobain Abrasives, Inc.Optimized CMP Conditioner Design for Next Generation Oxide/Metal CMP
US20090105815 *Oct 10, 2008Apr 23, 2009Matthew KreverPush-in retainer system for use in the direct plication annuloplasty treatment of mitral valve regurgitation
US20090105816 *Oct 10, 2008Apr 23, 2009Olsen Daniel HSystem using a helical retainer in the direct plication annuloplasty treatment of mitral valve regurgitation
US20090228059 *Apr 27, 2009Sep 10, 2009Shuros Allan CMethod and device for lymphatic system monitoring
US20100076408 *Dec 22, 2008Mar 25, 2010Matthew KreverDeflecting guide catheter for use in a minimally invasive medical procedure for the treatment of mitral valve regurgitation
US20100087836 *Oct 7, 2008Apr 8, 2010Kardium Inc.Surgical Instrument and Method for Tensioning and Securing a Flexible Suture
US20100087837 *May 7, 2009Apr 8, 2010Kardium Inc.Surgical Instrument and Method for Tensioning and Securing a Flexible Suture
USD777925Nov 19, 2014Jan 31, 2017Kardium Inc.Intra-cardiac procedure device
USD777926Nov 19, 2014Jan 31, 2017Kardium Inc.Intra-cardiac procedure device
DE102011076217A1May 20, 2011Nov 22, 2012Siemens AktiengesellschaftVerfahren zur Unterstützung einer einen minimalinvasiven, eine Punktion eines Septums insbesondere eines Herzens umfassenden Eingriff mit einem Katheter durchführenden Person und Röntgeneinrichtung
DE102011078678A1Jul 5, 2011Jan 10, 2013Siemens AktiengesellschaftMethod for generating three-dimensional representation of patient heart using X-ray apparatus, involves leading contrast agent into right atrium vessel, particularly inferior vena cava, or into right ventricle, after dosing
WO2016097846A3 *Dec 17, 2015Sep 1, 2016QuickRing Medical Technologies, Ltd.Surgical stabilizer
Classifications
U.S. Classification606/41, 128/898
International ClassificationA61B18/14
Cooperative ClassificationA61B2017/00243, A61B2017/00566, A61B18/1492, A61B2018/00619, A61B18/1442, A61B2018/00357, A61B2017/306
European ClassificationA61B18/14V, A61B18/14F
Legal Events
DateCodeEventDescription
Sep 18, 2009ASAssignment
Owner name: ABBOTT VASCULAR INC., CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:EVALVE, INC.;REEL/FRAME:023245/0637
Effective date: 20090909
Owner name: ABBOTT VASCULAR INC.,CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:EVALVE, INC.;REEL/FRAME:023245/0637
Effective date: 20090909