Source: http://www.google.es/patents/US8523883
Timestamp: 2017-11-20 17:41:27
Document Index: 178254935

Matched Legal Cases: ['Application No. 00944803', 'Application No. 00944803', 'Application No. 00944803', 'Application No. 00944803', 'Application No. 02749755', 'Application No. 02749755', 'Application No. 02749755', 'Application No. 2001', 'Application No. 2001']

Patente US8523883 - Apparatus and methods for treating tissue - Google Patentes
Apparatus and methods are provided for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. Mechanical clips are implanted over the leaflets of a valve, e.g., in the heart, either alone or after thermal treatment to cause...http://www.google.es/patents/US8523883?utm_source=gb-gplus-sharePatente US8523883 - Apparatus and methods for treating tissue
Número de publicación US8523883 B2
Número de solicitud US 13/212,842
Fecha de presentación 18 Ago 2011
Fecha de prioridad 25 Jun 1999
También publicado como EP1411849A1, EP1411849A4, US6626899, US7186262, US7217284, US7562660, US8333204, US20020035361, US20030018358, US20040133192, US20070129758, US20070208357, US20090264994, US20110301699, WO2003003930A1
Número de publicación 13212842, 212842, US 8523883 B2, US 8523883B2, US-B2-8523883, US8523883 B2, US8523883B2
Inventores Vahid Saadat
Citas de patentes (437), Otras citas (60), Citada por (16), Clasificaciones (62), Eventos legales (3)
US 8523883 B2
Apparatus and methods are provided for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. Mechanical clips are implanted over the leaflets of a valve, e.g., in the heart, either alone or after thermal treatment to cause the valve to close more tightly. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve channel. The clips can be coated with drugs or a radiopaque coating. Alternatively, individual anchors with a tensioning element, like a suture, may be used to approximate the valves towards each other. The catheter can also incorporate sensors or energy delivery devices, e.g., transducers, on its distal end.
1. A method of reducing a diameter of a mitral valve of a heart to reduce regurgitation of blood across the mitral valve, the method comprising:
providing a plurality of anchors coupleable to a tensioning element;
advancing a catheter into a left ventricle of the heard and delivering the plurality of anchors through the catheter;
deploying a plurality of anchors into heart tissue around the periphery of the mitral valve where the plurality of anchors are connectable to the tensioning element;
cinching the tensioning element once connected to the plurality of anchors to approximate opposing sides of the mitral valve to draw or close the opening of the valve;
securing the tensioning element to maintain tension across the tensioning element and plurality of anchors; and
removing the catheter from the left ventricle.
2. The method of claim 1, where the tensioning element is sequentially coupled to each anchor.
3. The method of claim 1, where deploying, the plurality of anchors into heart tissue comprises deploying the plurality of anchors with the tensioning element pre-threaded through the anchors.
4. The method of claim 1, where deploying the plurality of anchors into heart tissue further comprises threading the tensioning element with the anchors after the anchors are positioned in tissue.
5. The method of claim 1, where securing the tensioning element to maintain tension comprises affixing a fastener to the tensioning element.
6. The method of claim 1, where the tensioning element comprises a suture or wire.
7. The method of claim 1, where advancing the catheter into the left ventrical comprises advancing the catheter through the vasculature.
8. The method of claim 1, where deploying the plurality of anchor comprises sequentially advancing each of the anchor from the catheter into heart tissue.
9. An assembly for reducing a diameter of a mitral valve of a heart to reduce regurgitation of blood across the mitral valve, the assembly comprising:
a plurality of anchors configured to be implanted within muscle around a perimeter of the mitral valve through a catheter;
a tensioning member sequentially connectible to each anchor, the tensioning member having sufficient strength for cinching the tensioning element once sequentially connected to the plurality of anchors to approximate opposing sides of the mitral valve to draw or close the opening of the valve; and
a catheter containing the plurality of anchors and the tensioning element, where the catheter is sufficiently flexible to navigate through the vasculature and into a left atrium.
10. The assembly of claim 9, where the distal end of each of the anchors is barbed.
11. The assembly of claim 9, where the proximal end of each of the anchors is indented.
12. The assembly of claim 9, where the anchors each define at least one notch along a length of the member adjacent to the opening.
13. The assembly of claim 9, where the anchor embers each define a sharpened edge at least partially around the opening.
14. The assembly of claim 9, where the distal end of the anchors is bioabsorbable.
15. The assembly of claim 9, further comprising a fastener adapted to maintain a tensile force within the tensioning element once the tensioning element cinches the anchors and tissues.
16. The assembly of claim 15, where the fastener is adapted to allow unidirectional tensioning within the tensioning element.
17. The assembly of claim 15, where the fastener comprises a ratchet biased to remain in contact with the tensioning element.
18. The assembly of claim 9, where the tensioning element comprises a suture or a wire.
This application is a continuation of U.S. patent application Ser. No. 12/489,258 filed Jun. 22, 2009, which is a continuation of Ser. No. 11/622,442 filed Jan. 11, 2007, which is a continuation of U.S. patent application Ser. No. 10/188,509 filed Jul. 3, 2002 (now U.S. Pat. No. 7,186,262), which is a continuation-in-part of U.S. patent application Ser. No. 09/898,726 filed Jul. 3, 2001 (now U.S. Pat. No. 6,626,899), which is a continuation-in-part of U.S. patent application Ser. No. 09/602,436 filed Jun. 23, 2000 (now U.S. Pat. No. 6,669,687), which claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 60/141,077 filed Jun. 25, 1999, each of which is incorporated herein by reference in its entirety.
Aside from mechanical clips, individual anchors having a tightening element, such as a suture or wire, threaded through each anchor may alternatively be deployed around the valve. When desirably placed, the tightening element may be tightened to draw each of the anchors towards one another, thereby reducing the valve diameter.
FIG. 1 is a side-sectional view of a human heart showing major structures of the heart, including those pertaining to valvular degeneration;
FIG. 2 is a side view of apparatus of a first family of embodiments constructed in accordance with the present invention;
FIG. 4 is a sectional view through the human heart, depicting a method of using the apparatus of FIG. 2 to shrink tissue in an annulus surrounding the leaflets of a regurgitating valve;
FIGS. 5A and 5B are schematic views of alternative embodiments of the apparatus of FIG. 2;
FIGS. 8A and 8B are side views of another alternative embodiment of the apparatus of FIG. 6 having multipolar, individual electrodes;
FIG. 9 is a side view of an alternative embodiment of the apparatus of FIG. 8 having individual ultrasonic transducers;
FIG. 10 is a side-sectional view of another alternative embodiment of the apparatus of FIG. 8 having individual laser fibers;
FIG. 11 is a side-sectional view of an alternative embodiment of the apparatus of FIGS. 8-10 having individual barb members that may comprise multipolar electrodes, ultrasonic transducers, or laser fibers;
FIG. 12 is a sectional view through the human heart, illustrating an alternative method of introducing apparatus of the first family of embodiments to a treatment site;
FIGS. 13A and 13B are views of an alternative embodiment of the apparatus of FIG. 2 shown, respectively, in schematic side view and in use shrinking an annulus of tissue;
FIGS. 14A and 14B are, respectively, a side view of an alternative embodiment of the apparatus of FIG. 2, and a method of using the embodiment via the introduction technique of FIG. 12;
FIGS. 15A and 15B are isometric views of an alternative end effector for use with the apparatus of FIG. 14;
FIG. 16 is a top view of apparatus of a second family of embodiments constructed in accordance with the present invention;
FIG. 17A-17C are views of end effectors for use with the apparatus of FIG. 16;
FIG. 18 is a sectional view of the human heart, illustrating a method of using the apparatus of FIG. 16 to selectively induce a temperature rise in the chordae tendineae sufficient to cause a controlled degree of shortening of the tendineae;
FIGS. 21A and 21B are side views of apparatus of a third family of embodiments, constructed in accordance with the present invention, shown in a collapsed delivery configuration and in an expanded deployed configuration;
FIGS. 22A and 22B are schematic views depicting a method of using the apparatus of FIG. 21 to mechanically shorten an effective length of chordae tendineae; and
FIG. 23 is a side view, partially in section, illustrating a method and apparatus for non-invasive coagulation and shrinkage of scar tissue in the heart, or shrinkage of the valve structures of the heart.
FIG. 24A is an isometric view of a variation on a valve resizing device as an expandable grid with anchoring ends.
FIG. 24B is a top view of another variation on the valve resizing device as an expandable mesh.
FIGS. 25A-25F are side views of exemplary anchors which may be used with a valve resizing device.
FIG. 26 is a cross-sectional superior view of a heart section with the atrial chambers removed for clarity with the device of FIG. 24A implanted over a valve.
FIGS. 27A and 27B are a top view showing variations on a circumferential clip.
FIG. 28 is a cross-sectional superior view of a heart section with the atrial chambers removed for clarity with the device of FIG. 27A implanted around a valve.
FIGS. 29A and 29B show a side view and an end view, respectively, of a variation on a clip.
FIGS. 30A and 30B show a side view and an end view, respectively, of another variation on a clip.
FIG. 37 shows a cross-sectional view of a variation on the distal section of a delivery catheter.
FIG. 38 shows a cross-sectional view of another variation on the distal section of a delivery catheter where the clip is held in a different configuration.
FIG. 39 shows a cross-sectional view of yet another variation on the distal section of a delivery catheter.
FIGS. 40A and 40B are top and side views of a variation on a handle for controlling the advancement of the clip.
FIGS. 41A and 41B illustrate a cross-sectional view of a heart and a possible method of delivering and implanting a clip over the heart valve.
FIG. 41C is a cross-sectional view of a heart and a variation on the delivery catheter having a sensing device or a transducer integrated on the distal end.
FIGS. 43A and 43B are a superior view and a side view of a valve, respectively, showing an alternative clip configuration implanted on the valve.
FIGS. 44A and 44B are cross-sectional superior views of a heart section with the atrial chambers removed for clarity with anchors implanted around the mitral valve.
FIG. 45 is a cross-sectional superior views of a heart section with the atrial chambers removed for clarity with anchors implanted within the coronary sinus to approximate the tissue around the mitral valve.
FIG. 46A shows a cross-sectional side view of one variation on a delivery catheter for delivering and implanting anchoring devices.
FIG. 46B shows an end view of the delivery catheter of FIG. 46A.
FIG. 46C shows a cross-sectional view of another variation on the delivery catheter of FIG. 46A.
FIG. 47 shows a cross-sectional side view of another variation on a delivery catheter for delivering and implanting anchoring devices.
FIG. 48 shows an isometric view of a cartridge/pusher device for use within a delivery catheter.
FIG. 49A shows an isometric view of one variation of a crimping/fastening device for maintaining a tightened suture.
FIGS. 49B-49E show cross-sectional side views of variations on the crimping/fastening device.
FIG. 50 shows an isometric view of an alternative device, with the wall partially removed, for severing a tensioning element using a heating element.
FIG. 51 shows a side view of a variation on an implantable anchor with a removable obturator.
FIGS. 52A-52C show side and cross-sectional side views of another variation on the anchor having a rotatable portion.
FIGS. 53A and 53B show constrained and deployed configurations for yet another variation on anchors.
FIG. 54 shows a side view of yet another variation on an anchor having a bioabsorable piercing tip.
FIG. 3A also provides a cross section through an embodiment of catheter 32, along sectional view line A-A, for use in conjunction with the balloon embodiment of end effector 34. Catheter 32 comprises coolant lumens 48 a and 48 b that may circulate coolant C into and out of balloon 40, respectively. It further comprises wires 49 a-49 c, electrically coupled to electrode 42 a, electrode 42 b, and temperature sensors 46, respectively.
Monopolar electrode 66 is electrically coupled to RF source 68, which is positioned outside of the patient. RF source 68 is, in turn, coupled to reference electrode 69. When RF source 68 is activated, current flows between monopolar electrode 66 and reference electrode 69, which may, for example, be attached to the exterior of the patient in the— region of the treatment site. RF current flows into the wall of the treatment site, thereby effecting annular tissue shrinkage, as described previously.
FIGS. 6C and 6D provide a method of using apparatus 80 to treat annulus of tissue A surrounding a heart valve. Apparatus 80 is percutaneously advanced to the surface of a heart valve in the delivery configuration of FIG. 6C. Once positioned at annulus A, the distal region of apparatus 80 approximates the shape of the annulus, as seen in FIG. 6D. This may be accomplished, for example, with a steering mechanism comprising two purchase points or a pre-shaped tip that is retracted within a straight guiding catheter to allow insertion into the vascular system, as described in U.S. Pat. No. 5,275,162, which is incorporated herein by reference. Once inserted, the pre-shaped tip is advanced out of the guide catheter and recovers its preformed shape.
Referring now to FIG. 7A-7C, an alternative embodiment of end effector 84 of FIG. 6 is described. The end effector of FIG. 7 is equivalent to the end effector of FIG. 6 except that it is coated with electrically insulating layer I. Insulation layer I covers the entire exterior of end effector 84, except at the distal ends of the plurality of electrodes 94. The layer is preferably sufficiently thin to allow insertion of electrodes 94 into tissue T without impediment. The exposed distal ends of the electrodes are configured to deliver energy into subsurface tissue at treatment zones Z. The zones may be ideally modeled as spheres of subsurface tissue. Tissue shrinks within treatment zones Z without damaging surface tissue, as seen in FIG. 7B.
The size of treatment zones Z may he controlled to ensure that tissue remodeling only occurs at depth. Assuming a temperature T.sub.1, at which tissue damage is negligible, the magnitude of current passed through tissue T may be selected (based on the material properties of the tissue and the depth of insertion of electrodes 94 within the tissue) such that the temperature decays from a temperature T.sub.0 at a position D.sub.0 at the surface of an electrode 94 to the benign temperature T.sub.1 at a distance D.sub.1 from the surface of the electrode. The distance D.sub.1 may be optimized such that it is below the surface of tissue T. An illustrative temperature profile across a treatment zone Z is provided in FIG. 7C.
In FIG. 10, apparatus 120 comprises catheter 122 and end effector 124. Catheter 122 comprises a plurality of central bores 126 and a plurality of side bores 128, as well as a plurality of optional temperature sensors 130. End effector 124 comprises a plurality of side-firing fiber optic laser fibers 132 disposed within central bores 126 of catheter 122. The fibers are aligned such that they may deliver energy through side bores 128 to heat and induce shrinkage-in target tissue. Fibers 132 are coupled to a laser source (not shown), as discussed with respect to FIG. 3B. Suitable wavelengths for the laser source preferably range from visible (488-514 nm) to infrared (0.9-10.6 microns), wherein each wavelength has an ability to heat tissue to a predetermined depth. As an example, a preferred laser source comprises a continuous wave laser having a 2.1 micron wavelength, which will shrink and heat tissue to a depth of 1-2 mm.
Fibers 152 may comprise any of a number of energy delivery elements. For example, fibers 152 may comprise a plurality of optical fibers coupled to a laser (not shown). The wavelength of the laser may be selected as described hereinabove, while the energy deposited by the fibers may be controlled responsive to the temperature recorded by sensors 150. Thus, for example, a controller (not shown) may be provided to switch off the laser once a preset temperature, for example, 45.degree. C.-75.degree. C., is attained, thereby ensuring that a sufficiently high temperature is achieved to cause tissue shrinkage without inadvertently damaging surrounding tissues.
FIGS. 15A and 15B show an alternative end effector for use with apparatus 170 of FIG. 14. End effector 180 is shown in an open position and in a closed position, respectively, and comprises jaws 182 a and 182 b. End effector 180 is similar to end effector 174, except that jaws 182 are configured to engage tissue with a forceps grasping motion wherein bent tips 184 a and 184 b of the jaws are disposed parallel to one another and contact one another when closed.
FIG. 17B shows an embodiment of end effector 204 with fixed, straight arms 220 a and 220 b. The arms are configured to engage and disengage chordae tendineae simply by being positioned against the tendineae. FIG. 17C shows an embodiment of the end effector having arms 230 a and 230 b. Multiple heating elements 212 are disposed on arm 230 a. When heating elements 212 comprise bipolar electrodes, current flow through the tendineae using the embodiment of FIG. 17C may be achieved primarily along a longitudinal axis of the tendineae, as opposed to along a radial axis of the tendineae, as will be achieved with the embodiment of FIG. 17A. These alternative heating techniques are described in greater detail hereinbelow with respect to FIGS. 19 and 20.
When energy is transmitted through tissue utilizing one of the embodiments of this invention, the tissue absorbs the energy and heats up. It may therefore be advantageous to equip the end effector with temperature or impedance sensors, as seen in the embodiments of FIG. 17, to output a signal that is used to control the maximum temperature attained by the tissue and ensure that the collagen or other tissues intended to be shrunk are heated only to a temperature sufficient for shrinkage, for example, a temperature in the range of 45.degree. C.-75.degree. C., and even more preferably in the range of 55.degree. C.-65.degree. C. Temperatures outside this range may be so hot as to turn the tissue into a gelatinous mass and weaken it to the point that it loses structural integrity. A closed loop feedback system advantageously may be employed to control the quantity of energy deposited into the tissue responsive to the output of the one or more sensors. In addition, the sensors may permit the clinician to determine the extent to which the cross-section of a chordae has been treated, thereby enabling the clinician to heat treat only a portion of the cross-section.
FIGS. 19A-19C depict a method of shrinking a section of chordae tendineae CT in a zig-zag fashion using the embodiment of end effector 204 seen in FIG. 17C. In FIG. 19A, the tendineae has an initial effective or straight length L.sub.1. Arms 230 engage chordae tendineae CT, and heating elements 212 are both disposed on the same side of the tendineae on arm 230 a. The heating elements may comprise bipolar electrodes, in which case the path of current flow through tendineae CT is illustrated by arrows in FIG. 19A.
Collagen within the tendineae shrinks, and chordae tendineae CT assumes the configuration seen in FIG. 19B. Treatment zone Z shrinks, and the tendineae assumes a shorter effective length L.sub.2. Treatment may be repeated on the opposite side of the tendineae, as seen in FIG. 19C, so that the tendineae assumes a zig-zag configuration of still shorter effective length L.sub.3. In this manner, successive bands of treatment zones Z and intact longitudinal fiber bundles may be established.
Referring to FIGS. 21A and 21B, apparatus 300 comprises catheter 302 and end effector 304. End effector 304 comprises mechanical reconfigurer 306, adapted to mechanically alter the length of a longitudinal member, for example, chordae tendineae. Reconfigurer 306 comprises a preshaped spring fabricated from a shape memory alloy, for example, nitinol, spring steel, or any other suitably elastic and strong material. Reconfigurer 306 is preshaped such that there is no straight path through its loops. Overlap between adjacent loops is preferably minimized. The shape of reconfigurer 306 causes longitudinal members, such as chordae tendineae, passed therethrough to assume a zig-zag configuration and thereby be reduced in effective length. Reconfigurer 306 is collapsible to a delivery configuration within catheter 302, as seen in FIG. 21A, and is expandable to a deployed configuration, as seen in FIG. 21B. The reconfigurer optionally may be selectively detachable from catheter 302.
The variations of clip geometries described herein may be manufactured in several ways. One method involves securing a wire, band, or other cross-sectioned length, preferably made of a superelastic or shape memory material, to a custom forming fixture (not shown). The fixture preferably has a geometry similar to the valve or opening where the completed clip is to be placed and the fixture preferably has a diameter which is smaller than the diameter of the valve or opening. The fixture diameter may be determined by the amount of closure by which the valve or opening may need to be closed or approximated to reduce or eliminate valvular regurgitation. The fixture, with a constrained clip placed thereon, may be subjected to a temperature of about 500.degree. to 700.degree. F. preferably for a period of about 1 to 15 minutes. Additional details about the processing and performance of superelastic and shape memory materials may be seen in U.S. Pat. No. 5,171,252 to Friedland, which is incorporated herein by reference in its entirety. The fixture and clip may then be removed and subjected to rapid cooling, e.g., quenching in cold water. The clip may then be removed from the fixture and the ends of the clip may be trimmed to a desired length. The trimmed ends may also be formed into a sharpened point by, e.g., grounding, to facilitate piercing of the tissue.
FIG. 24A shows a variation of a valve resizing device in expandable grid 360. Grid 360 is shown as having alternating member 362 formed of a continuous alternating length while forming several anchoring regions 364, which may be radiused. The number of alternating members (and number of resultant anchoring regions 364) formed may be determined by a variety of factors, e.g., the geometry of the valve to be resized or the amount of spring compression required. Grid 360 is preferably made of a shape memory alloy, as discussed above. The terminal ends of alternating member 362 preferably end in anchoring ends 366. Anchoring ends 366 may define a range of angles with the plane formed by alternating member 362, e.g., 45.degree., but is preferably formed perpendicular to the plane. Ends 366 may be formed integrally from alternating member 362, which may first be cut to length, by reducing a diameter of ends 366 to form, e.g., a barbed end or double-barbed end as shown in the figure and in the detail view. Alternatively, anchoring ends 366 may be formed separately and attached to the ends of alternating member 362 by, e.g., adhesives, welding, or scarfjoints. The ends 366 are shown in this example as a double-barbed anchoring fastener, but generally any type of fastening geometry may be used, e.g., single-barbs, semi-circular or triangular ends, screws, expandable locks, hooks, clips, and tags, or generally any type of end geometry that would facilitate tissue insertion yet resist being pulled or lodged out. Also, sutures and adhesives, as well as the barbs, may be used to fasten grid 360 to the tissue.
Another variation on a grid-type device is shown in FIG. 24B as expandable mesh 368. In this variation, several individual intenvoven members 370 may be woven together to form a continuous mesh. Members 370 may be either welded together or loosely interwoven to form expandable mesh 368. In either case, the geometries of both expandable grid 360 and mesh 368 are formed to preferably allow a compressive spring force yet allow a relative degree of expansion once situated on the valve or opening.
To maintain grid 360 or mesh 368 over the valve or opening, fasteners located around the valve or opening are preferably used for anchoring grid 360 or mesh-368. Fasteners are preferably made of a biocompatible material with relatively high strength, e.g., stainless steel or Nickel-Titanium. Biocompatible adhesives may also be, used. A variation of such a fastener is shown in FIG. 25A. Anchor 372 is shown having a barbed distal end 374 for piercing tissue and for preventing anchor 372 from being pulled out. Shown with a double-barb, it may also be single-barbed as well. Stop 376, which is optional, may be located proximally of distal end 374 to help prevent anchor 372 from being pushed too far into the tissue. A protrusion, shown here as eyelet 378, is preferably located at the proximal end of anchor 372 and may extend above the tissue surface to provide an attachment point. Grid 360 or mesh 368 may be looped through eyelet 378 or they may be held to eyelet 378 by sutures or any other conventional fastening methods, e.g., adhesives.
Yet another variation on fasteners is shown in FIGS. 25C-25F. FIG. 25D shows a side view of anchor 381, which is preferably barbed at then distal end 383 to facilitate insertion into tissue and subsequent anchoring. Proximal end 385 is indented in this variation to facilitate the loading and delivery of multiple anchors 381 to a tissue region for treatment. This may be accomplished by loading multiple anchors 381 within a delivery catheter such that the tapered proximal end of one anchor 381 abuts within the indentation 385 of the distal end of an adjacent anchor 381, as will be described in further detail below.
Defined within shank 389, which may have a diameter, e.g., of at least 0.2 mm, of anchor 381 is eyelet or suture hole 387. Eyelet 387 may be defined along anchor 381 such that it rests either above the tissue surface, at the tissue surface, or even below it when anchor 381 has been positioned within the tissue. Eyelet 387 provides a hole through which a suture may be tied to or looped through to provide the desired anchoring points to draw the opposing sides of the valve towards one another. FIG. 25C shows a cross-sectional end view taken from FIG. 25D showing eyelet 387 defined through shank 389. When a suture or other tensioning element, e.g., a wire, is drawn through eyelet 387 the suture may be tensioned, as described further below, and the remaining suture may be cut to leave the tensioned suture(s) and implanted anchors 381 in place within the tissue. To cut or remove the suture, eyelet 387 may have a sharpened or tapered edge 391 defined entirely around its circumference or just partially around, as shown in FIG. 25E. When the suture has been positioned within eyelet 387, a crimping or clamping tool (not shown) may be advanced to within the area and used to then crimp anchor 381 at notches 393 to collapse eyelet 387 and to bring sharpened edge 391 to cut or sever the suture positioned therethrough. In this instance, shank 389 will have been crimped over the remaining suture material and will firmly hold it. Alternatively, the crimper/fastener of FIGS. 49A-49E may be used to achieve the same result.
FIG. 25F shows yet another variation on anchor 395. Anchor 395 may have a distal end which is tapered and sharpened to facilitate insertion into the tissue and a proximal end which is indented to facilitate loading of the anchor during deployment, as described further below. Eyelet 401 may be defined along the anchor body proximally of distal end 399 to provide a location for the suture or tensioning element to pass. Proximal of distal end 399, one or several retractable arms 397 may be formed such that arms 397 are pivotable to lie against the anchor body during loading and delivery, as shown by retracted position 397′. During deployment into the tissue, retracted arms 397′ may be configured to extend outwardly into its expanded configuration 397 such that pulling anchor 395 out of the tissue is inhibited by the extended arms 397 digging into the tissue. The diameter formed by the extended arms 397, i.e., the expanded diameter, is preferably larger than the diameter formed by the retracted arms 397′, i.e., the retracted diameter, such that a ratio of the expanded diameter to the retracted diameter is on the order of between about 2:1 to 50:1.
Any of the anchor variations may be optionally coated with a therapeutic agent or antimicrobial agent to facilitate healing or to effect some other results, like timed drug delivery or to act as an anti-thrombosis agent. Alternatively, a radiopaque coating layer may be coated over either one, several, or all of the anchors for deployment to facilitate visualization during deployment and/or placement using any conventional visualization techniques. The coatings may vary and may include, e.g., Nickel-Titanium alloy, Platinum, Palladium, Gold, and/or Tantalum.
FIG. 26 shows a cross-sectional superior view of e.g., human heart section 390, with the atrial chambers removed for clarity. Heart tissue 392 is seen surrounding tricuspid valve 400 and bicuspid or mitral valve 402. Sectioned ascending aorta 394 and pulmonary trunk 396 are also seen as well as coronary sinus 398 partially around the periphery of heart section 390. An example of expandable grid 360 in a deployed configuration is shown over mitral valve 402. Grid 360 may be placed entirely over valve 402 and anchored into heart tissue 392 by anchors 404, which may be of a type shown in FIGS. 25A or 25B, at anchoring regions 364. Once grid 360 is in place, it may impart a spring force which may draw the opposing sides of valve 402 towards one another, thereby reducing or eliminating valvular regurgitation.
Another variation on a biasing clip device is shown in FIGS. 27A and 27B. FIG. 27A shows circumferential clip 406 having opposing members 408. This clip variation, preferably made of a shape memory alloy, e.g., Nickel-Titanium alloy, may be inserted into the tissue surrounding a valve. This clip may surround the periphery of the valve and provide an inwardly biased spring force provided by opposing members 408 to at least partially cinch the valve. The variation in FIG. 27A preferably surrounds about 50% to 75% of the valve circumference. The variation of clip 410 is shown in FIG. 27B with opposing members 412. Here, the clip may be made to surround at least about 50% of the valve circumference. FIG. 28 again shows the cross-sectional superior view of heart section 390 except with circumferential clip 406 placed in the tissue 392 around valve 402. As shown, opposing members 408 preferably provide the inwardly biased spring force to at least partially cinch valve 402.
Another variation is seen in FIGS. 31A to 31D. FIG. 31A shows a top view of arcuate valve clip 424. Clip 424 preferably has an arcuate central member 426, which is shown as a semicircle having a radius, R. Central member 426 may serve to act as a stress-relieving member, as described above, and it may also be designed to prevent any blockage of the valve by clip 424 itself. Thus, radius, R, is preferably large enough so that once clip 424 is placed over the valve, central member 426 lies over the valve periphery. FIG. 31B shows a side view of the clip. This view shows anchoring members 430 attached by bridging members 428 on either end to central member 426. FIG. 31C shows an end view of the clip where the anchoring members 430 and central member 426 are clearly shown to lie in two different planes defining an angle, .alpha., therebetween. The angle, .alpha., may vary greatly and may range from about 60.degree. to 120.degree., but is preferably about 90.degree. for this variation. Finally, FIG. 31D shows an isometric view of clip 424 where the biplanar relationship between anchoring members 430 and central member 426 can be seen.
FIG. 38 shows catheter section 436 with another compressed variation of clip 454. Here, clip 454 may be compressed into a “U” or “V” shape for delivery and deployed in the same manner by plunger 448 and stylet 450 through delivery port 442, as discussed above. This variation enables the ends of clip 454 to be deployed simultaneously; however, this variation may also require a larger delivery port 442 than the variation shown in FIG. 37.
FIG. 39 shows a further variation of the distal end of deployment catheter section 456. This variation shows catheter body 458 with delivery lumen 460 terminating in distal tip 461, much like the variations shown above. But here, distal tip 461 does not have a delivery port defined through it, rather delivery port 462 is preferably defined along a distal length of catheter body 458 proximally of distal tip 461. Clip 464 may be any of the variational shapes described above but is shown here in a compressed arcuate shape. Clip 464 may be held within catheter section 456 by an external constraining sheath or it may be held simply by friction fitting clip 464 within delivery port 462. Catheter section may be steered to the desired target site via steering lumen 468 and once in position, deployment stylet 466 may be urged towards the distal end of section 456 in much the same manner as described above. However, stylet 466 is preferably angled at its distal tip to facilitate pushing clip 464 out through delivery port 462.
FIGS. 40A and 40B show a top and side view, respectively, of an example of catheter handle 470 which may be used to advance the clip into position over a valve or opening. This variation shows handle 470 with distal end 472, where the catheter is preferably attached, and the linear advancement mechanism, shown here as thumb-slide 474. Thumb-slide 474 may be advanced in advancement slot 476 towards distal end 472 to urge the plunger and stylet. Within handle 470, the advancement of thumb-slide 474 may be controlled by an indexing mechanism, e.g., a screw, ratchet, or some type of gear, which may allow the proximal and distal movement of the thumb-slide 474 through slot 476.
Then, as shown in FIG. 41B, distal end 480 may be moved or steered to the opposite side of the annulus of tissue A after or while the rest of clip 484 is advanced through delivery port 482. The distal end 480 is preferably moved to the opposite side of the mitral valve MV at about 180.degree., if possible, from the initial contact point to allow for optimal reduction of the diameter of the valve. Once distal end 480 is positioned on the opposing side of the valve, the plunger may then be finally advanced so that the remaining second end of clip 484 exits delivery port 482 and engages the annulus of tissue A.
Once proper orientation has been determined, a first clip 498 a, which may be compressed in catheter 490 may be urged out of delivery port 492 a by a plunger and stylet, as described above or twisted out, and pushed through a wall of the coronary sinus 398 and through the adjacent heart tissue 392, as shown in FIG. 42B. The clips are preferably made of a superelastic or shape memory alloy, e.g., Nickel-Titanium alloy (e.g., nitinol), and are preferably made to expand as it exits catheter 490. Accordingly, clip 498 a may be pushed until the farthest anchoring member of clip 498 a is in contact with and enters the edge of valve 402 farthest from catheter 490. As clip 498 a finally exits delivery port 492 a, the anchoring member may exit and then engage the edge of valve 402 closest to catheter 490. This procedure may be repeated for several clips, as seen in FIG. 42C, where first and second clip 498 a, 498 b, respectively, are shown to have already exited and engaged the tissue surrounding valve 402. FIG. 42D shows the final engagement of third clip 498 c having exited delivery port 492 c and engaged the tissue surrounding valve 402. Once the clips are in place, the compressive, spring force of the clips may aid in drawing the opposing sides of valve 402 together, thereby drawing or cinching opening 488 close and reducing or eliminating the occurrence of valvular regurgitation through the valve. The use of three clips is merely exemplary and any number of desired or necessary clips may be used.
FIGS. 43A and 43B show the valve of FIGS. 42A-42D and a side view of the valve, respectively. FIG. 43A shows another example of arcuate clips 500 a, 500 b, as described in FIGS. 31A-31D, engaged to mitral valve 402. Arcuate clips 500 a, 500 b are designed such that the curved region of each clip is preferably opposite to each other in order to keep opening 488 unobstructed. FIG. 43B shows a side view of valve 402 in annulus 502. Clips 500 a, 500 b are preferably engaged to the tissue surrounding annulus 502, e.g., to annulus walls 504.
Aside from the use of clips to engage the valve tissue, indented anchor 395, as shown above in FIG. 25F, may alternatively be used to reduce the diameter and thereby the regurgitation across the valve. FIG. 44A shows one example for using deploying anchors 395 as an alternative variation to the approximation devices described above. The cross-sectional superior view of heart section 390 is shown again with the atrial chambers removed for clarity. Heart tissue 392 is seen surrounding tricuspid valve 400 and bicuspid or mitral valve 402. In this example, delivery catheter 508 may be used, through any of the delivery methods described above, to position delivery port 510 of the catheter 508 proximate to, e.g., mitral valve 402. Catheter 508 may be used to selectively position a number of anchors 395 around the perimeter of valve 402. The optimal number of anchors 395 used may depend upon the size of the valve to be approximated and/or the desired resulting approximation effects.
The anchors 395 may be pre-threaded with a suture 506 or other tensioning element, e.g., a wire, prior to loading or delivery into tissue 392. Alternatively, anchors 395 may be first placed into tissue 392 and subsequently threaded with suture 506. In either case, suture 506 is preferably positioned such that it surrounds the periphery of the valve 402, as shown. After the individual anchors 395 are positioned around the valve 402, suture 506 may be tightened by pulling on the proximal end of suture 506 through catheter 508 and drawing suture 506 through a crimp or other adjustable fastener. This tightening will approximate the opposing sides of valve 402 to draw or close the opening of valve 402. Once the desired degree of approximation has been effected, suture 506 may be cut by crimping one of the anchors 395, as described above, or by severing suture 506 with a crimp adapted to cut suture 506, and the tools may be removed from the region.
FIG. 44B shows the deployed anchors 395 surrounding valve 402 with suture 506 forming a closed loop and having been tightened to approximate the valve leaflets. Crimp or fastener 507 is shown as maintaining the tension across suture 506 and valve 402 with the excess suture and deployment catheter 508 having been removed from the area.
FIG. 45 shows another variation in the deployment of anchors 395 to reduce the diameter of, in this example, valve 402. In this example, anchors 395 may be deployed and positioned within the coronary sinus 398 around the periphery of where mitral valve 402 is located. Suture 506 may be tied or affixed to one of the terminally located anchors 395′ or 395″ and suture 506 may be tightened through the remaining anchors 395. This tightening of suture 506 draws the tissue 392 together, which in turn approximates the leaflets of valve 402. This method eliminates the need to enter within the heart and also eliminates the need to form a looped suture 506. A crimper/fastener 507 may alternatively be used to tighten the suture against the proximal terminating anchor 395′.
FIG. 46A shows a cross-sectional side view of one variation: of a delivery catheter for delivering and implanting anchors 381 of FIG. 25D. Delivery catheter 508 in this particular variation may comprise an outer delivery member which defines delivery port 510 at its distal end through which anchors 381 may be delivered. Catheter 508 may have a diameter ranging from 3-5 mm and may be any variety of intralumenal vascular catheter suitable for such an application. It may also be a steerable catheter which may be selectively maneuvered via a pull wire, as appreciated by one of skill in the art. Within the lumen of catheter 508, a separate cartridge/pusher 512 may be slidably disposed and adapted to hold the individual anchors 381 in a linear tip-to-tail configuration, as described above and as shown in the figure. The distal end of cartridge 512 may be enclosed by release port 516, which may be adapted to selectively hold anchors 381 within cartridge 512 until plunger 514 is actuated via actuator 518, e.g., which can be a pneumatically, electrically, or electromagnetically driven pusher, as known in the art, which may be manipulated by the surgeon to push a selective number of anchors 381 out of cartridge 512. After an anchor 381 has been ejected from cartridge 512, release port 516 closes behind anchor 381 to leave anchor 381 within the space between cartridge 512 and delivery port 510. Cartridge 512 may then be actuated by the surgeon to move distally to push anchor 381 beyond port 510 and into the tissue.
When the anchors 381 are loaded within cartridge 512, the tensioning element or suture 506 is preferably pre-threaded through anchors 381. The suture 506 is threaded through the first anchor 381 and through each successive anchor 382 until it is threaded through the last one. Then the suture is threaded alongside anchors 381 and brought back to approximate the other end of the suture 506 to form a loop. The two suture ends are threaded through fastener 507 for final tightening/crimping and cutting.
FIG. 46B shows an end view of the catheter 508 from FIG. 46A. As seen, release port 516 may be configured in one variation as a leaf valve 520 which is adapted to hold anchors 381 within catheter 508 until they are actively and selectively ejected via the cartridge/pusher 512. The leaf valves 520 can bend outwardly towards delivery port 510 but not inwardly into cartridge/pusher 512. This effect allows cartridge/pusher 512 to force the anchors 381 out of the delivery port 510 and into the tissue. FIG. 46C shows a cross-sectional view of another variation df an integral catheter body 522. Within this variation, anchors 381 may be disposed within cartridge lumen 524 and the tensioning element or suture may be disposed within one or both of working lumens 526.
FIG. 47 shows a cross-sectional side view of another variation of a delivery catheter for delivering and implanting anchors 395 of FIG. 25F. As seen, anchors 395 may be positioned within cartridge/pusher 512, which itself resides slidably within delivery catheter 508. Retracted arms 397′ are shown in their retracted state while positioned within cartridge/pusher 512 and delivery catheter 508. Suture 506 is shown passing through each of the eyelets of anchors 395 and looping through the first anchor 395 positioned by delivery port 510 to be looped back towards the proximal end of delivery catheter 508, where the terminal ends of suture 506 may be passed through crimp or fastener 507. In use, anchors 395 may be deployed in the same manner. Actuator 518 may be actuated to push an anchor 395 out of cartridge 512 and proximal to port 510. When ready for deployment into the tissue, anchor 395 may be pushed via cartridge 512 to eject anchor 395 out of catheter 508.
FIG. 48 shows an isometric view of one variation of cartridge/pusher 512 removed from catheter 508. As shown, cartridge 512 may define a pushing surface 528 where anchors may be pushed with cartridge/pusher 512. Along the length of the body of cartridge 512, a narrow slot or channel 530 may be defined to allow suture 506 and/or crimp or fastener 507 to pass through.
FIG. 49A shows an isometric view of one variation of crimp or fastener 532 which may be used to maintain the tension within the suture after the valve tissue has been approximated. This variation may define a fastener body with a channel 536 defined therethrough within which suture 506 may pass freely. One end of channel 536 may have a sharpened edge or blade 534 which may be positioned at least partially around the perimeter of channel 536 such that crimping fastener 532 will cause edge 534 to collapse into channel 536 and sever suture 506.
Although fastener 532 may be configured to allow suture 506 to pass freely therethrough, fastener 532 is preferably designed to allow for the uni-directional travel of suture 506 through the fastener 532. This allows suture 506 to be tightened through the anchors but prevents suture 506 from slipping back and releasing the tension within the anchors and the valve tissue. FIGS. 49B-49E show various alternative designs which allow for the uni-directional tensioning of suture 506. FIG. 49B shows a cross-sectional side view of one variation of fastener 538 in which tension is maintained within suture 506 via ratchet 542. As fastener 538 is passed over suture 506 through channel 540 (fastener 538 moves from left to right), ratchet 542 allows suture 506 to pass freely yet remains in contact due to the biasing force of spring element 546. However, when suture 506 slips in the opposite direction, ratchet 542 rotates about pivot 544 and is stopped by stop 548. The edge of ratchet 542 effectively digs into suture 506 to stop the reverse movement of suture 506 (and to stop de-tensioning from occurring). After suture 506 has been desirably tightened, fastener 538 may be crimped along where blade 550 is positioned to bring blade 550 against suture 506 to sever it from the deployed anchors.
FIG. 49C shows a cross-sectional side view of another variation of fastener 552. In this variation, ratchet 554 may be formed integrally within fastener 552 housing. A roughened suture 506′ is preferably used to present a roughened surface to ratchet 554. This variation operates similarly to the variation above, but is simpler in construction and operates in much the same manner as a zip-tie. As suture 506′ is passed through the fastener channel 556, the angle of ratchet 554 allows for the unidirectional travel of suture 506′ from right to left. If pulled in the opposite direction, ratchet 554 digs into the roughened surface and prevents the reverse movement of suture 506′. After suture 506′ has been desirably tensioned, fastener 552 may be crimped to sever suture 506′ with blade 558.
FIG. 49D shows yet another variation of fastener 560 which is similar to the variation of FIG. 49B. As shown, ratchet 542 may rotate about pivot 544 while remaining in contact with suture 506 due to the biasing force of spring element 546. The rotation of ratchet 542 is limited by stop 548, which enables ratchet 542 to press suture 506 against housing 560, thereby stopping the movement of fastener 560 relative to suture 506. FIG. 49E shows another variation for fastener 562 which utilizes roughened or beaded suture 506″. Suture 506″ preferably defines a plurality of beaded elements periodically along its length. Ratchet 566 is configured such that it may open in one direction, thereby allowing the passage of suture 506″ through, yet movement of suture 506″ in the opposite direction forces ratchet 566 to close due to the biasing force of biasing spring element 568. Ratchet 566 is preferably configured such that suture 506″ may pass through in the reverse direction, but because of beaded elements 564, further slippage of suture 506″ is prevented.
Any of the fastening devices described above may be made of biocompatible metals, e.g., stainless steel, nickel and/or titanium alloys, etc., or they may be manufactured from biocompatible plastics, e.g., PTFE, etc.
Some of the fasteners above incorporated a tapered or sharpened edge to sever the suture when completely tightened. An alternative design is shown in FIG. 50, which uses a heating element to sever the tightening element or suture. This particular severing design may be used with the fasteners of FIGS. 49D and 49E, which are made without the sharpened edge. This variation may have conductive wires 574 positioned within the length of delivery catheter body 570 within separate insulating lumens. A portion 576 of conductive wires 574 may be looped within delivery lumen 572 to surround suture 506. After the tightening of suture 506 has been accomplished, portion 576 may be heated to melt and subsequently sever suture 506 where in contact to effectively release the anchors and tensioned suture without the use of a sharpened edge or blade.
In addition to the fastening elements, the anchoring elements may be further modified. FIG. 51 shows another variation of anchor 578 which may have a obturator 582 removably positionable within lumen 580 of anchor 578. Eyelet 579 may be seen defined within the body of anchor 578 for the passage of the tensioning element therethrough. To insert anchor 578 within the tissue, obturator 582 may be positioned within lumen 580 to facilitate piercing and positioning of the anchor within the tissue. When desirably positioned, obturator 582 may then be removed leaving anchor 578 implanted within the tissue. This may be desirable since no sharpened objects are left remaining within the tissue.
FIGS. 52A-52C show side and cross-sectional views of a rotatable anchor 584 which facilitates placement of the sutures around the valve 402. This variation has anchor body 586 which houses rotatable portion 588 within. Rotatable portion 588 preferably has eyelet 590 defined therethrough. The head of rotatable portion 588 sits atop rotational shaft 592 which preferably has one or several grooves 594 defined thereon to receivingly mate with keyed portions 594 defined within anchor body 586. Keyed portions 594 are configured to interfit with grooves 596 to allow the free rotation of portion 588 within body 586 while preventing portion 588 from being removed. The rotational configuration prevents the tensioning element from wrapping about the anchor during the tensioning procedure.
Another alternative anchor mechanism is shown in FIGS. 53A and 53B. FIG. 53A shows an undeployed anchor 598 which is formed from at least two members 600, 602 interconnected via biasing element 604, e.g., a spring. Biasing element 604 may be pretensioned to deploy members 600, 602 from a straightened configuration, as in FIG. 53A, to a deployed criss-cross configuration, as shown in FIG. 53B, upon removal of a constraining force, e.g., such as when deployed from the delivery catheter. Members 600, 602 may be inserted within the tissue and then released such that it reconfigures itself and thereby anchors within the tissue. A suture or tensioning element may be threaded, e.g., via eyelet 601, through one or both members 600, 602 to effect the tensioning and approximation of valve tissue.
FIG. 54 shows yet another alternative for anchor mechanism in anchor 606. This variation is similar to those shown above, particularly in FIG. 25F; however, piercing tip 610 is made from a bioabsorbable material and is separately attachable to body 608. Tip 610 is preferably attached distally of retractable arms 612 such that after insertion within the tissue, tip 610 may be absorbed within the tissue leaving body 608 implanted anchored via arms 612. Because the piercing tip 610 is absorbed, the number of sharp objects left within the tissue is reduced or eliminated.
US3166072 22 Oct 1962 19 Ene 1965 Jr John T Sullivan Barbed clips
US4204283 3 May 1978 27 May 1980 National Research Development Corporation Prosthetic valve
US4731075 17 Dic 1985 15 Mar 1988 Gallo Mezo Jose I Bicuspate cardiac-valve prosthesis
US5059201 22 Ene 1991 22 Oct 1991 Asnis Stanley E Suture threading, stitching and wrapping device for use in open and closed surgical procedures
US6027499 30 Mar 1998 22 Feb 2000 Fiber-Tech Medical, Inc. (Assignee Of Jennifer B. Cartledge) Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa
US7562660 * 11 Ene 2007 21 Jul 2009 Hansen Medical, Inc. Apparatus and methods for treating tissue
US8333204 * 22 Jun 2009 18 Dic 2012 Hansen Medical, Inc. Apparatus and methods for treating tissue
1 European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., Communication under Rule 71(3) mailed Nov. 20, 2009.
2 European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., office action mailed Aug. 8, 2008.
3 European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., office action mailed Mar. 16, 2009.
4 European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., Search Report mailed Jun. 3, 2005.
5 European Patent Application No. 02749755.1 filed Jul. 3, 2002 in the name of Houser et al., Office Action mailed Dec. 16, 2009.
6 European Patent Application No. 02749755.1 filed Jul. 3, 2002 in the name of Houser et al., Office Action mailed Mar. 1, 2011.
7 European Patent Application No. 02749755.1 filed Jul. 3, 2002 in the name of Houser et al., Search Report mailed Sep. 16, 2009.
8 Hayashi, K. et al. (1997). "The Effect of Thermal Heating on the Length and Histologic Properties of the Glenohumeral Joint Capsule", The American Journal of Spoils Medicine, 25(1): 107-112.
9 Japanese Patent Application No. 2001-505831 filed Jun. 23, 2000 in the name of Saadat et al., Notice of Allowance mailed Jun. 29, 2010.
10 Japanese Patent Application No. 2001-505831 filed Jun. 23, 2000 in the name of Saadat et al., office action mailed Jan. 12, 2010.
11 Naseef III, G. S. etal. (1997). "The Thermal Properties of Bovine Joint Capsule, The Basic Science of Laser -and Radiofrequency-Induced Capsular Shrinkage", The American Journal ofSports Medicine, 25(5):670-674.
12 PCT Patent Application No. PCT/US2000/017270 filed Jun. 23, 2000 in the name of Saadat, Search Report mailed Oct. 12, 2000.
13 PCT Patent Application No. PCT/US2002/020996 filed Jul. 3. 2002 in the name of Houser et al., Search Report mailed Sep. 19, 2002.
14 PCT Patent Application No. PCT/US2005/007108 filed Mar. 4, 2005 in the name of Wallace et al., Search Report and Written Opinion mailed Jun. 26, 2005.
15 PCT Patent Application No. PCT/US2005/028877 filed Aug. 12, 2005 in the name of Moll et al., Search Report and Written Opinion mailed Nov. 22, 2005.
16 PCT Patent Application No. PCT/US2006/044655 filed Nov. 15, 2006 in the name of Loulmet, Search Report and Written Opinion mailed May 1, 2007.
17 Selecky, M. T. et al. (1996). "The Effects of Laser-Induced Collagen Shortening on the Biomechanical Properties of the Inferior Glenohumeral Ligament Complex", University of Southern California, School of Medicine, Department of Orthopaedic Surgery, Los Angeles, California, 90033, pp. 1-25.
18 U.S. Appl. No. 09/602,436, filed Jun. 23, 2000 in the name of Saadat, Non-Final Office Action mailed Jan. 29, 2003.
19 U.S. Appl. No. 09/602,436, filed Jun. 23, 2000 in the name of Saadat, Non-Final Office Action mailed Jul. 16, 2002.
20 U.S. Appl. No. 09/602,436, filed Jun. 23, 2000 in the name of Saadat, Non-Final Office Action mailed Mar. 29, 2002.
21 U.S. Appl. No. 09/602,436, filed Jun. 23, 2000 in the name of Saadat, Notice of Allowance mailed Sep. 12, 2003.
22 U.S. Appl. No. 09/898,726, filed Jul. 3, 2001 in the name of Houser et al., Final Office Action mailed Feb. 26, 2003.
23 U.S. Appl. No. 09/898,726, filed Jul. 3, 2001 in the name of Houser et al., Non-Final Office Action mailed Sep. 25, 2002.
24 U.S. Appl. No. 09/898,726, filed Jul. 3, 2001 in the name of Houser et al., Notice of Allowance mailed Jun. 2, 2003.
25 U.S. Appl. No. 10/188,409, filed Jul. 3, 2002 in the name of Saadat, Notice of Allowance mailed Sep. 19, 2006.
26 U.S. Appl. No. 10/188,509, filed Jul. 3, 2002 in the name of Saadat, Non-Final Office Action mailed Feb. 12, 2004.
27 U.S. Appl. No. 10/188,509, filed Jul. 3, 2002 in the name of Saadat, Non-Final Office Action mailed Jul. 27, 2005.
28 U.S. Appl. No. 10/188,509, filed Jul. 3, 2002 in the name of Saadat, Non-Final Office Action mailed Nov. 5, 2004.
29 U.S. Appl. No. 10/188.509, filed Jul. 3, 2002 in the name of Saadat, Final Office Action mailed Mar. 3, 2006.
30 U.S. Appl. No. 10/669,204, filed Sep. 23, 2003 in the name of Houser et al., Final Office Action mailed Feb. 9, 2005.
31 U.S. Appl. No. 10/669,204, filed Sep. 23, 2003 in the name of Houser et al., Final Office Action mailed Jul. 14, 2006.
32 U.S. Appl. No. 10/669,204, filed Sep. 23, 2003 in the name of Houser et al., Non-Final Office Action mailed May 18, 2004.
33 U.S. Appl. No. 10/669,204, filed Sep. 23, 2003 in the name of Houser et al., Non-Final Office Action mailed Nov. 22, 2005.
34 U.S. Appl. No. 10/669,204, filed Sep. 23, 2003 in the name of Houser et al., Notice of Allowance mailed Jan. 8, 2007.
35 U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Final Office Action mailed Dec. 21, 2010.
36 U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Final Office Action mailed Jan. 21, 2010.
37 U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Non-Final Office Action mailed Jun. 10. 2009.
38 U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Non-Final Office Action mailed Jun. 8, 2010.
39 U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Notice of Allowance mailed Mar. 10, 2011.
40 U.S. Appl. No. 11/176,957, filed Jul. 6, 2005 in the name of Wallace et al., Final Office Action mailed Oct. 26, 2010.
41 U.S. Appl. No. 11/176,957, filed Jul. 6, 2005 in the name of Wallace et al., Non-Final Office Action mailed May 10, 2010.
42 U.S. Appl. No. 11/176,957, filed Jul. 6, 2005 in the name of Wallace et al.. Notice of Allowance mailed Mar. 17, 2011.
43 U.S. Appl. No. 11/185,432, filed Jul. 19, 2005 in the name of Hlavka et al., Final Office Action mailed Sep. 25, 2009.
44 U.S. Appl. No. 11/185,432, filed Jul. 19, 2005 in the name of Hlavka et al., Non-Final Office Action mailed Apr. 8, 2010.
45 U.S. Appl. No. 11/185,432, filed Jul. 19, 2005 in the name of Hlavka et al., Non-Final Office Action mailed Dec. 18, 2008.
46 U.S. Appl. No. 11/185,432, filed Jul. 19, 2005 in the name of Hlavka et al., Notice of Allowance mailed Feb. 16, 2011.
47 U.S. Appl. No. 11/185,432, filed Jul. 19, 2005 in the name of Hlavka et al., Notice of Allowance mailed Nov. 1, 2010.
48 U.S. Appl. No. 11/185,432, filed Jul. 19, 2005 in the name of Hlavka et al., Supplemental Notice of Allowance mailed May 10, 2011.
49 U.S. Appl. No. 11/202,925, filed Aug. 12, 2005 in the name of Hlavka et al., Final Office Action mailed Oct. 27, 2010.
50 U.S. Appl. No. 11/202,925, filed Aug. 12, 2005 in the name of Hlavka et al., Non-Final Office Action mailed May 11, 2010.
51 U.S. Appl. No. 11/202,925, filed Aug. 12, 2005 in the name of Hlavka et al., Notice of Allowance mailed Apr. 12, 2011.
52 U.S. Appl. No. 11/286,037, filed Nov. 23, 2005 in the name of Loulmet, Non-Final Office Action mailed Jan. 15, 2009.
53 U.S. Appl. No. 11/286,037, filed Nov. 23, 2005 in the name of Loulmet, Notice of Allowance mailed Sep. 17, 2009.
54 U.S. Appl. No. 11/622,442, filed Jan. 11, 2007 in the name of Saadat, Non-Final Office Action mailed Jun. 25, 2008.
55 U.S. Appl. No. 11/622,442, filed Jan. 11, 2007 in the name of Saadat, Notice of Allowance mailed Mar. 23, 2009.
56 U.S. Appl. No. 11/743,343, filed May 2, 2007 in the name of Houser et al., Final Office Action mailed May 5, 2010.
57 U.S. Appl. No. 11/743,343, filed May 2, 2007 in the name of Houser et al., Non-Final Office Action mailed Jul. 21, 2009.
58 U.S. Appl. No. 12/489,258, filed Jun. 22, 2009 in the name of Saadat, Non-Final Office Action mailed Feb. 15, 2011.
59 U.S. Appl. No. 12/608,849, filed Oct. 29, 2009 in the name of Loulmet, Final Office Action mailed Mar. 23, 2011.
60 U.S. Appl. No. 12/608,849, filed Oct. 29, 2009 in the name of Loulmet, Non-Final Office Action mailed Jun. 24, 2010.
US9034032 19 Jul 2013 19 May 2015 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9034033 19 Jul 2013 19 May 2015 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9039757 15 Mar 2013 26 May 2015 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9161837 * 27 Jul 2012 20 Oct 2015 The Cleveland Clinic Foundation Apparatus, system, and method for treating a regurgitant heart valve
US9421098 16 Dic 2011 23 Ago 2016 Twelve, Inc. System for mitral valve repair and replacement
US9572662 4 May 2016 21 Feb 2017 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9585751 4 May 2016 7 Mar 2017 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9655722 14 Mar 2014 23 May 2017 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9763780 19 Oct 2012 19 Sep 2017 Twelve, Inc. Devices, systems and methods for heart valve replacement
US20130190798 * 27 Jul 2012 25 Jul 2013 Samir Kapadia Apparatus, system, and method for treating a regurgitant heart valve
US20150065709 * 13 Mar 2013 5 Mar 2015 Metabomics, Inc Aminoquinazoline Derivative And Use Thereof In Preparing Anti-Malignant Tumor Medicament
Clasificación de EE.UU. 606/144, 128/898, 606/153, 623/2.12, 606/158, 606/151
Clasificación internacional A61B18/00, A61B18/14, A61F2/24, A61B17/00, A61N7/00, A61B19/00, A61B17/12, A61B17/28, A61B18/24
Clasificación cooperativa A61B2017/044, A61B2018/1432, A61B17/1285, A61B17/0469, A61B2017/0496, A61B2017/0454, A61B2017/0458, A61N7/00, A61B2018/00023, A61B2017/0451, A61B2018/00214, A61B2018/00273, A61B18/1442, A61B2017/0461, A61B2090/064, A61B90/39, A61B2017/0464, A61B18/1492, A61B2018/00083, A61B2018/00797, A61B17/0401, A61F2/2454, A61F2/2451, A61B2017/00867, A61B2018/1253, A61B2017/00084, A61B2018/1435, A61F2/2445, A61B2018/0022, A61B18/00, A61B17/29, A61B2018/00791, A61B2017/0409, A61B2018/126, A61B18/1477, A61B2017/0437, A61B2018/00232, A61B17/122, A61B18/24, A61B2017/0414, A61N7/02, A61B2017/0427, A61B17/0487, A61B2017/00243, A61B2017/2945, A61B2018/00369, A61B2017/0412
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SAADAT, VAHID;REEL/FRAME:027243/0925
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:NIDUS MEDICAL, LLC;REEL/FRAME:027243/0953
3 Dic 2013 CC Certificate of correction