US20140207011A1 - Universal valve annulus sizing device - Google Patents
Universal valve annulus sizing device Download PDFInfo
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- US20140207011A1 US20140207011A1 US14/222,598 US201414222598A US2014207011A1 US 20140207011 A1 US20140207011 A1 US 20140207011A1 US 201414222598 A US201414222598 A US 201414222598A US 2014207011 A1 US2014207011 A1 US 2014207011A1
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- valve annulus
- measuring portion
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- 210000003709 heart valve Anatomy 0.000 claims abstract description 19
- 238000000034 method Methods 0.000 claims description 27
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2496—Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6871—Stomach
Definitions
- the present invention relates to devices and methods for measuring the size of an anatomical valve annulus, and more particularly, to devices for use in measuring the size of a cardiac valve annulus in conjunction with implantation of an expandable prosthetic heart valve.
- aortic valve prostheses have been considered for replacing diseased or defective native cardiac valves (e.g., the aortic valve).
- One such type of prosthetic heart valve includes a radially collapsible/expandable stent, which supports a set of valve leaflets.
- the stent is radially contracted during implantation of the prosthetic valve at the desired location.
- the stent is sized such that, if unrestrained, it can expand to a diameter somewhat greater than the diameter of the annulus of the valve to be replaced and/or the vessel proximate to the native valve (i.e., in the case of an aortic valve prosthesis, the ascending aorta).
- the annulus includes dense, fibrous rings attached to the adjacent atrial or ventricular muscle fibers.
- the physician excises the defective native valve leaflets to prepare the annulus for implantation of the replacement valve.
- physicians use a set of sizing obturators, which are provided by various heart valve manufacturers, to obtain an estimate of the diameter of the native valve annulus.
- These sizing obturators typically include a cylindrical body having a flat, annular flange thereabout.
- the physician typically advances the flange to a location adjacent the superior aspect of the valve annulus, but does not typically advance the flange to an intra-annular position. This process may require the physician to repeatedly introduce various sizing obturators to the valve annulus to obtain this size estimate. This procedure requires much time and effort and offers minimal accuracy. This procedure also relies significantly on the skill of the implanting physician, as proper sizing is largely based upon the skill and technique of the physician.
- the present invention is a device for measuring an internal dimension of a native cardiac valve annulus.
- the device includes an elongated support member having a proximal portion and a distal portion including an end having a bore and a longitudinal slot, a measuring band having a first end and a second end, the first end disposed within the bore and the second end coupled to the distal portion, a shaft extending through the support member, the shaft having a distal end coupled to the first end of the measuring band and a proximal end, and an indicator coupled to the proximal end of the shaft, the indicator adapted to provide an indication of the internal dimension.
- the measuring band has a contracted configuration in which the band is at least partially wound about a transverse axis and an expanded configuration in which the band is substantially unwound.
- the present invention is a device for measuring an internal dimension of a native cardiac valve annulus, the device comprising a body portion and a measuring portion, the measuring portion including an expandable element configured to substantially adapt to the shape of the annulus.
- the present invention is a method of implanting an expandable prosthetic valve at a native valve annulus.
- the method includes removing a native valve leaflet, debriding the native valve annulus, stressing the valve annulus by applying a force similar to that applied by a prosthetic valve, obtaining an estimate of the perimeter of the valve annulus, selecting an appropriate prosthetic valve based on the estimate, and implanting the appropriate prosthetic valve at the native valve annulus.
- the present invention is a method of implanting an expandable prosthetic valve at a native valve annulus.
- the method includes removing a native valve leaflet, debriding the native valve annulus, stressing the valve annulus by applying a force similar to that applied by a prosthetic valve, obtaining an estimate of the perimeter of the valve annulus, selecting an appropriate prosthetic valve based on the estimate, and implanting the appropriate prosthetic valve at the native valve annulus.
- kits for implanting a sutureless prosthetic heart valve comprising a sizing tool for measuring an internal dimension of a native cardiac valve annulus, the sizing tool comprising an expandable element configured to substantially adapt to the shape of the annulus, and an expandable, stented prosthetic heart valve.
- the prosthetic heart valve in some embodiments, generates a first radial force against the valve annulus upon implantation and the expandable element generates a second radial force, the second radial force differs from the first radial force by less than about 10%.
- FIG. 1 is a perspective partial cut-away view of a valve sizer in a deployed state according to one embodiment of the present invention.
- FIGS. 2A-2B are perspective views of the valve sizer of FIG. 1 in deployed and undeployed configurations.
- FIGS. 3A-3C are a perspective view, a top plan view and an end plan view, respectively, showing the measuring band in a fully extended configuration.
- FIGS. 4A-4B are a perspective view and an end plan view of the measuring band in a contracted configuration.
- FIGS. 5A-5B are a perspective view and an end plan view of the measuring band in a deployed configuration.
- FIGS. 6A-6B are schematic views showing the measuring band in a contracted and a deployed configuration, respectively.
- FIG. 7 is a schematic view illustrating a sizing device according to another embodiment of the present invention.
- FIG. 8 is a partial sectional view of the sizing device shown in FIG. 7 .
- FIG. 9 is a schematic view of an exemplary embodiment of the measuring portion of the sizing device shown in FIG. 7 in deployed and undeployed configurations.
- FIG. 10 is a flow chart showing a method of sizing a valve annulus, according to an embodiment of the present invention.
- FIG. 1 is a perspective partial cut-away view of a valve sizing device 10 in a deployed state within a patient's aortic valve annulus 14 , according to one embodiment of the present invention. While the following description of the various embodiments of the present invention are generally described with reference to an aortic valve annulus, it is also useful for measuring a dimension of other cardiac valve annuli, including for example the pulmonary valve annulus. Further, the devices of the present invention can be used to measure other valve annuli as well as the inner dimensions of vessels or other tubular anatomical structures.
- the left ventricle 18 is coupled to the ascending aorta 20 .
- the left ventricle 18 pumps blood out of the heart through the aortic valve and into the ascending aorta 20 .
- the aortic valve is a semilunar valve including a set of valve leaflets surrounding the aortic annulus 14 , which is defined by the periannular tissue located at the most distal portion of the left ventricular outflow tract.
- the annulus 14 includes dense, fibrous rings attached to the adjacent atrial or ventricular muscle fibers. As shown in FIG.
- the sizing device 10 is positioned to allow measurement of a diameter and/or a perimeter of the aortic annulus 14 . As shown, access to the annulus 14 is obtained from a superior position through an incision in the ascending aorta 20 .
- the native aortic valve leaflets have been removed. It will be appreciated, however, that removal of the native valve leaflets is not a requirement of the sutureless aortic valve replacement procedure. That is, in various embodiments, the valve prosthesis can be implanted without removing the native valve leaflets.
- the sizing device 10 may be used in connection with implantation of an expandable/contractible replacement heart valve of the type generally known in the art.
- the sizing device 10 may be used, for example, in connection with any sutureless aortic valve prostheses, for example, including percutaneously delivered aortic valve prostheses.
- the sizing device 10 is used in connection with implantation of any of the prosthetic valves disclosed in co-pending and commonly assigned U.S. patent application Ser. Nos. 11/066,346 and 11/352,021, the disclosures of which are incorporated herein by reference in their entireties.
- FIGS. 2A-2B are perspective views of the valve sizer of FIG. 1 in deployed and undeployed configurations, respectively.
- the sizing device 10 includes a main body portion 24 supporting a measuring portion 28 .
- the measuring portion or band 28 is disposed in an expanded configuration, in which the measuring band 28 has an effective diameter larger than that of the distal end of the main body portion 24
- the measuring band 28 is disposed in a collapsed configuration, in which it has an effective diameter about equal to that of the distal end of the main body portion 24 .
- This expandable/collapsible design facilitates delivery of the tool using standard minimally-invasive delivery techniques and instruments.
- This design also provides the device 10 with the ability to measure a wide variety of valve annuli, each having a distinct diameter or perimeter dimension.
- the main body portion 24 includes an elongated support member 32 , which couples an adjustable member or knob 34 at its proximal end to an adjustment mechanism 36 at its distal end.
- a shaft or coupling rod (not shown) extends through an internal lumen in the elongated support member 32 and rotationally couples the adjustable knob 34 to the adjustment mechanism 36 .
- the support member 32 includes a linkage or plurality of linkages, which allow adjustment of the orientation and shape of the handle (e.g., both angularly and rotatably) relative to the adjustable portion 36 .
- the support member 32 may include a locking mechanism to allow the physician to lock the position of the support member when desired.
- all or a portion of the support member 32 may be made flexible in addition to or in lieu of the inclusion of the linkages, thereby providing alternative or additional flexibility in orienting the adjustment mechanism 36 inside the valve annulus.
- the device 10 is configured such that the adjustment mechanism 36 responds to movement imparted on the adjustable knob 34 .
- a physician could apply a rotational force having a desired magnitude to the adjustable knob 34 .
- This force in-turn causes a corresponding rotation of the adjustment mechanism 34 .
- This rotation of the adjustment mechanism causes deployment of the measuring band 28 .
- the measuring band 28 is biased to an open or expanded position, such that it self-expands inside the valve annulus, which causes rotation of the adjustment mechanism 36 , which in-turn causes rotation of the adjustable knob 34 .
- the adjustable knob 34 or the adjustment mechanism 36 include a latch or lock for retaining the measuring band in the collapsed configuration. The physician may then manipulate this latch or lack at an appropriate time, to allow the measuring band to deploy or expand.
- annular member 38 is coupled near a proximal end of the elongated support member 32 adjacent the adjustable knob 34 .
- the annular member or indicator 38 includes indicia 40 disposed circumferentially about the annular member. These indicia are configured to indicate a degree of deployment of the measuring band 28 .
- the indicia 40 include various numbers representative of the diameter of the measuring band in millimeters.
- the indicia 40 are configured to indicate an effective length (i.e., the length extending out of the adjustment mechanism 36 ) of the measuring band.
- an effective length i.e., the length extending out of the adjustment mechanism 36
- FIGS. 3A-3C show various views of the adjustment mechanism 36 located at a distal end of the sizing device 10 .
- the measuring band 28 has been partially disassembled from the adjustment mechanism 36 .
- the adjustment mechanism 36 includes a cylindrical holder 44 , the measuring band 28 , and a hub portion 45 .
- the cylindrical holder 44 which has a proximal end 46 and a distal end 48 , is structurally separate from the elongated support member 32 .
- the proximal end 46 of the cylindrical holder 44 is adapted to couple to a distal end of the sizing device 10 , such as for example by use of an interference fit with a distal portion of the support member 32 .
- the cylindrical holder is an integrally formed portion of the distal end of the elongated support member 32 . In either case, the cylindrical holder is fixed both longitudinally and rotationally during use of the device.
- the cylindrical holder 44 includes an opening or slot 52 extending longitudinally through a portion thereof. In some embodiments, the slot 52 extends along the entire length of the holder 44 from the proximal end 46 to the distal end 48 . Adjacent the slot 52 is a coupling edge 54 . As shown, the holder 44 also includes an annular lip 56 located at the distal end 48 . In other embodiments, the holder 44 includes an annular lip at the proximal end 46 as well. The cylindrical holder 44 defines an internal, central chamber or bore 60 .
- the measuring band 28 includes an elongated portion extending from a proximal end 64 to a distal end 68 .
- the proximal end 64 is coupled to the holder 44 at or near the coupling edge 54 .
- the distal end 68 of the measuring band 28 is coupled to the hub portion 45 .
- the hub portion 45 includes a protrusion 72 defining an internal engagement portion 76 .
- the protrusion 72 and engagement portion 76 facilitation coupling of the hub portion 45 to the coupling rod, which extends from the adjustment mechanism 36 to the proximal end of the sizing device 10 .
- the measuring band 28 may be made from any material having suitable physical characteristics.
- the band 28 is made from a biocompatible polymeric or metallic material.
- the band 28 is self-expandable, the band is made from a polymer or metal having shape memory and/or superelastic properties.
- shape memory and/or superelastic properties are nickel-titanium alloys, such as nitinol.
- the measuring band has a length of between about 150 and 190 mm, a height of between about 1 and 10 mm, and a thickness of about 0.05 and 2 mm. In other embodiments, the measuring band may include other dimensions as appropriate for use of the ban in measuring the circumference of a valve annulus.
- the measuring band 28 includes a longitudinally extending radiopaque portion to facilitate visualization of the measuring band during use of the device.
- the longitudinally extending edge (or edges) of the measuring band 28 are tapered or otherwise softened, to help minimize trauma to the valve annulus 14 or adjacent tissue during a sizing procedure.
- the hub portion 45 and the measuring band 28 are removable from the holder 44 .
- the measuring band 28 and hub portion 45 of the sizing device 10 are readily disposable after use, while the remaining portions of the device may be sterilized and reused by the physician.
- the measuring band can be removed by unwinding and expanding the measuring band and then manipulating the measuring band around the distal annular lip 56 .
- the measuring band 28 and hub 45 can then be slid distally out of the holder 44 for disposal.
- a new, sterile measuring band 28 and hub 45 can then be inserted into the holder 44 , and the engagement portion 76 coupled to the coupling rod.
- FIGS. 4A-4B show the adjustment mechanism 36 in an assembled, collapsed configuration.
- the cylindrical holder 44 is shown separated from the elongated support member 32 .
- the measuring band 28 is wound about the holder 44 in a clockwise direction, such that it extends along an outer surface of the holder 44 , extends through the slot 52 , and extends along an internal surface of the holder 44 in the central chamber 60 .
- the proximal end 64 of the measuring band 28 is attached at or near the coupling edge of the holder 44 , and the distal end 68 of the measuring band is coupled to the hub portion 45 .
- the measuring band has a minimal effective diameter (D 1 ), which facilitates access to the valve annulus 14 using standard minimally invasive access techniques and instruments.
- D 1 minimal effective diameter
- the annular lip 56 extends radially outward from the holder a distance about equal to the thickness of the measuring band 28 .
- the leading (distal) edge of the measuring band is thus covered or protected by the annular lip 56 .
- the hub portion 45 is located inside the central chamber 60 , with portions of the measuring band 28 wound thereabout.
- FIGS. 5A-5B show the adjustment mechanism 36 in an assembled, expanded configuration.
- the cylindrical holder 44 is shown separated from the elongated support member 32 .
- the measuring band 28 is at least partially unwound, which results in an the measuring band 28 defining an expanded effective diameter (D 2 ).
- D 2 expanded effective diameter
- the proximal portion 64 of the measuring band 28 remains attached to the holder 44
- the distal portion 68 remains attached to the hub portion 45 .
- the hub portion 45 has rotated in the direction indicated by the arrow in FIG. 5B , to allow the measuring band to extend out through the slot 52 and away from the holder 44 .
- the effective length (i.e., the length extending out from the holder 44 ) corresponds to an amount of rotation of the central hub 45 .
- the measuring band expands outwardly from the holder 44
- the hub rotates in a clockwise direction
- the measuring band contracts towards the holder 44 .
- the hub portion 45 remains inside the holder 44 , but all or nearly all portions of the measuring band 28 have extended out through the slot 52 .
- FIGS. 6A-6B show schematic sectional views of a distal end of the sizing device 10 , which has been placed at an intra-annular location by the implanting physician.
- the native valve annulus 14 is not precisely cylindrical in cross section, but instead has a slightly trigonal sectional configuration.
- the sizing device 10 of the present invention is well suited to measure a diameter or perimeter dimension of a cylindrical annulus, it is also well suited to measure the effective diameter or perimeter of a non-cylindrical valve annulus.
- the device of the present invention is able to measure the perimeter of a valve annulus that includes calcification or other imperfections.
- the physician has located the adjustment mechanism 36 of the sizing device 10 inside the valve annulus, with the measuring band 28 in a contracted configuration.
- the physician activates the adjustment mechanism 36 to enable the measuring band 28 to expand radially outward into contact with an internal surface of the valve annulus, as shown in FIG. 6B .
- the materials and dimensions of the measuring band 28 are selected to enable the band to readily expand outward and to substantially or entirely conform to the inner surface of the valve annulus.
- the measuring band 28 is unwound and expanded manually by the implanting physician.
- the physician can expand and contract the measuring band by turning the adjustable knob 34 .
- the adjustable knob 34 is coupled (using, for example, a coupling rod) to the adjustment mechanism 36 .
- the adjustable knob is coupled to the hub portion 45 of the adjustment mechanism.
- the physician can effect a corresponding rotation of the hub portion, which in turn will effect an unwinding or unfurling of the measuring band 28 .
- the physician can rotate the adjustable knob 34 until she feels a certain degree of resistance, which corresponds to an amount of radial force applied by valve annulus 14 against the measuring band 28 .
- she determines that she has caused an appropriate amount of force against the valve annulus, she can read the indicia 40 on the handle, which indicates the corresponding diameter or effective length of the measuring band 28 .
- the sizing device 10 includes a torque limiting device of the type known in the art. This torque limiter is placed between the knob 34 and the adjustment mechanism 36 and prevents the physician from applying an excessive force of a magnitude that could cause damage to the native valve annulus.
- the measuring band 28 is made from a superelastic material, which is biased to the fully expanded configuration.
- the measuring band is made from a material and has dimensions selected such that the measuring band will expand to a diameter greater than the largest expected valve annulus diameter.
- the measuring band 28 is biased to an expanded configuration (such as that shown in FIG. 5A ) having an effective diameter of greater than about 26 mm.
- the material and dimensions of the measuring band 28 are also selected such that the measuring band generates an outward radial force against the inward-facing surface of the valve annulus 14 , which radial force approximates that radial force generated by the self-expandable prosthetic valve to be implanted in the valve annulus 14 .
- the radial force generates by the measuring band 28 differs from the radial force generated by the prosthetic heart valve by not more than 10 percent. In other embodiments, the radial forces differ by not more than 5 percent. In still other embodiments, the radial forces differ by not more than 2 percent.
- the sizing device 10 may obtain a more accurate measure of the internal dimensions of the valve annulus upon implantation of the prosthetic valve.
- the implantation of a self-expanding prosthetic valve may result in a change in shape and/or size of the valve annulus 14 , which changes will be detected by the sizing device 10 of the present invention.
- the implanting physician allows the measuring band to expand inside the valve annulus and then reads the corresponding dimensional information from the indicia 40 disposed on the annular member 38 .
- the measuring band 28 is sufficiently flexible to allow it to substantially conform to the internal surface of the valve annulus 14 .
- the measuring band 28 is able to readily take on a radius of curvature of less than about 2 mm. This flexibility allows the measuring band to substantially conform to valve annuli having irregular shapes.
- FIG. 7 is a schematic view illustrating a sizing device 100 according to another embodiment of the present invention.
- the device 100 includes a main body portion 104 and a measuring portion 108 .
- the device 100 is shown in one possible operating configuration with the main body portion or handle 104 extending through a vessel downstream from the valve and the measuring portion located generally insider the valve annulus.
- the measuring portion 108 is shown in a deployed or expanded configuration, such that the measuring portion 108 is in contact with an inner wall or surface of the valve annulus.
- FIG. 8 shows a partial sectional view of the sizing device 100 .
- the main body portion includes an elongated support member 110 , which couples an adjustable member 112 to the measuring portion 108 .
- the main body portion houses or contains a torque member or rod 116 , which is coupled to the adjustable member 112 at a proximal end and includes a threaded distal end 118 .
- the threads of the rod 116 engage corresponding threads of a tapered element 122 , such that a rotation applied to the adjustable member 112 causes rotation of the rod 116 , which in turn causes longitudinal motion of the tapered element 122 with respect to the main body portion 104 .
- the adjustable member includes an associates scale which is configured to indicate the corresponding diameter or circumference of the measuring portion 108 .
- the measuring portion 108 is self-expanding.
- the measuring portion 108 is expanded in an unbiased position, such that it defines an overall diameter that is slightly larger than a diameter of the target valve annulus.
- the measuring portion 108 is made from a polymer or metal having shape memory and/or superelastic properties. Once such class of superelastic materials well known in the art are nickel-titanium alloys, such as nitinol.
- the measuring portion is held in a collapsed or compressed configuration by a sheath or tube disposed over the elongated support member 110 .
- the measuring portion 108 is then deployed (i.e., allowed to self-expand) by retracting the sheath and allowing the measuring portion to expand radially into contact with an inner surface of a valve annulus.
- the elongated support member may include indicia which are disposed axially along the shaft such that the indicia correspond to a diameter or circumference of the measuring portion 108 . In this fashion, the indicia will provide the user with an indication of the diameter or circumference of the target valve annulus.
- FIG. 9 shows a schematic view of an exemplary embodiment of the measuring portion 108 .
- the measuring portion includes a plurality of measuring elements or petals 120 A to 120 F.
- the measuring portion 108 may include more or fewer petals 120 , as appropriate for measuring the desired valve annulus.
- the petals 120 are expandable (as described above) from a collapsed configuration to and expanded configuration.
- An exemplary expanded configuration is shown by the elements or petals marked 120 A′ to 120 F′.
- FIG. 10 is a flowchart illustrating one exemplary technique 200 for using the sizing device 10 or 100 of the present invention.
- the physician first removes the native anatomical valve leaflets from the valve (block 210 ).
- the physician then, in some embodiments, debrides or otherwise smoothes out the tissue at the valve annulus (block 220 ).
- the physician then introduces the sizing device 10 of the present invention to an intra-annular location and activates or releases the measuring band until it applies an outwardly directed force similar to that applied by the prosthetic valve to be implanted (block 230 ). While this force is being applied to the valve annulus, the physician reads an estimate of the annulus diameter or perimeter from the device (block 240 ). Based on this estimate of the annulus dimension, the physician selects an appropriately sized prosthetic valve (block 250 ). The physician then implants the appropriately sized valve at the native valve annulus (block 260 ).
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- Heart & Thoracic Surgery (AREA)
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Abstract
A device for measuring an internal dimension of a native cardiac valve annulus includes an elongated support member having a proximal portion and a distal portion. A measuring portion is coupled to the distal portion, and an indicator is coupled to the proximal portion of the support member. The measuring portion is biased towards a deployed configuration such that when deployed it applies an outwardly directed radial force to the native valve annulus.
Description
- This application is a continuation of U.S. application Ser. No. 12/727,098, filed Mar. 18, 2010, which claims the benefit of provisional application No. 61/161,462, filed Mar. 19, 2009, entitled “UNIVERSAL VALVE ANNULUS SIZING DEVICE,” which is herein incorporated by reference in its entirety.
- The present invention relates to devices and methods for measuring the size of an anatomical valve annulus, and more particularly, to devices for use in measuring the size of a cardiac valve annulus in conjunction with implantation of an expandable prosthetic heart valve.
- Various sutureless heart valve prostheses have been considered for replacing diseased or defective native cardiac valves (e.g., the aortic valve). One such type of prosthetic heart valve includes a radially collapsible/expandable stent, which supports a set of valve leaflets. Typically, the stent is radially contracted during implantation of the prosthetic valve at the desired location. To optimize performance, the stent is sized such that, if unrestrained, it can expand to a diameter somewhat greater than the diameter of the annulus of the valve to be replaced and/or the vessel proximate to the native valve (i.e., in the case of an aortic valve prosthesis, the ascending aorta).
- To ensure proper anchoring and operation of the prosthetic valve in situ, it is helpful to assess the size of the patient's anatomical valve annulus. The annulus includes dense, fibrous rings attached to the adjacent atrial or ventricular muscle fibers. In some valve replacement procedures, the physician excises the defective native valve leaflets to prepare the annulus for implantation of the replacement valve. Typically, physicians use a set of sizing obturators, which are provided by various heart valve manufacturers, to obtain an estimate of the diameter of the native valve annulus. These sizing obturators typically include a cylindrical body having a flat, annular flange thereabout. The physician typically advances the flange to a location adjacent the superior aspect of the valve annulus, but does not typically advance the flange to an intra-annular position. This process may require the physician to repeatedly introduce various sizing obturators to the valve annulus to obtain this size estimate. This procedure requires much time and effort and offers minimal accuracy. This procedure also relies significantly on the skill of the implanting physician, as proper sizing is largely based upon the skill and technique of the physician.
- The present invention, according to exemplary embodiments, is a device for measuring an internal dimension of a native cardiac valve annulus. The device includes an elongated support member having a proximal portion and a distal portion including an end having a bore and a longitudinal slot, a measuring band having a first end and a second end, the first end disposed within the bore and the second end coupled to the distal portion, a shaft extending through the support member, the shaft having a distal end coupled to the first end of the measuring band and a proximal end, and an indicator coupled to the proximal end of the shaft, the indicator adapted to provide an indication of the internal dimension. The measuring band has a contracted configuration in which the band is at least partially wound about a transverse axis and an expanded configuration in which the band is substantially unwound.
- The present invention, according to other embodiments, is a device for measuring an internal dimension of a native cardiac valve annulus, the device comprising a body portion and a measuring portion, the measuring portion including an expandable element configured to substantially adapt to the shape of the annulus.
- The present invention, according to other embodiments, is a method of implanting an expandable prosthetic valve at a native valve annulus. The method includes removing a native valve leaflet, debriding the native valve annulus, stressing the valve annulus by applying a force similar to that applied by a prosthetic valve, obtaining an estimate of the perimeter of the valve annulus, selecting an appropriate prosthetic valve based on the estimate, and implanting the appropriate prosthetic valve at the native valve annulus.
- The present invention, according to another embodiment is a method of implanting an expandable prosthetic valve at a native valve annulus. The method includes removing a native valve leaflet, debriding the native valve annulus, stressing the valve annulus by applying a force similar to that applied by a prosthetic valve, obtaining an estimate of the perimeter of the valve annulus, selecting an appropriate prosthetic valve based on the estimate, and implanting the appropriate prosthetic valve at the native valve annulus.
- Another embodiment of the present invention is a kit for implanting a sutureless prosthetic heart valve, the kit comprising a sizing tool for measuring an internal dimension of a native cardiac valve annulus, the sizing tool comprising an expandable element configured to substantially adapt to the shape of the annulus, and an expandable, stented prosthetic heart valve. The prosthetic heart valve, in some embodiments, generates a first radial force against the valve annulus upon implantation and the expandable element generates a second radial force, the second radial force differs from the first radial force by less than about 10%.
- While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
-
FIG. 1 is a perspective partial cut-away view of a valve sizer in a deployed state according to one embodiment of the present invention. -
FIGS. 2A-2B are perspective views of the valve sizer ofFIG. 1 in deployed and undeployed configurations. -
FIGS. 3A-3C are a perspective view, a top plan view and an end plan view, respectively, showing the measuring band in a fully extended configuration. -
FIGS. 4A-4B are a perspective view and an end plan view of the measuring band in a contracted configuration. -
FIGS. 5A-5B are a perspective view and an end plan view of the measuring band in a deployed configuration. -
FIGS. 6A-6B are schematic views showing the measuring band in a contracted and a deployed configuration, respectively. -
FIG. 7 is a schematic view illustrating a sizing device according to another embodiment of the present invention. -
FIG. 8 is a partial sectional view of the sizing device shown inFIG. 7 . -
FIG. 9 is a schematic view of an exemplary embodiment of the measuring portion of the sizing device shown inFIG. 7 in deployed and undeployed configurations. -
FIG. 10 is a flow chart showing a method of sizing a valve annulus, according to an embodiment of the present invention. -
FIG. 1 is a perspective partial cut-away view of avalve sizing device 10 in a deployed state within a patient'saortic valve annulus 14, according to one embodiment of the present invention. While the following description of the various embodiments of the present invention are generally described with reference to an aortic valve annulus, it is also useful for measuring a dimension of other cardiac valve annuli, including for example the pulmonary valve annulus. Further, the devices of the present invention can be used to measure other valve annuli as well as the inner dimensions of vessels or other tubular anatomical structures. - As is known, and as shown in
FIG. 1 , theleft ventricle 18 is coupled to theascending aorta 20. During normal operation, theleft ventricle 18 pumps blood out of the heart through the aortic valve and into the ascendingaorta 20. The aortic valve is a semilunar valve including a set of valve leaflets surrounding theaortic annulus 14, which is defined by the periannular tissue located at the most distal portion of the left ventricular outflow tract. Theannulus 14 includes dense, fibrous rings attached to the adjacent atrial or ventricular muscle fibers. As shown inFIG. 1 , thesizing device 10 is positioned to allow measurement of a diameter and/or a perimeter of theaortic annulus 14. As shown, access to theannulus 14 is obtained from a superior position through an incision in theascending aorta 20. In the illustrated embodiments, the native aortic valve leaflets have been removed. It will be appreciated, however, that removal of the native valve leaflets is not a requirement of the sutureless aortic valve replacement procedure. That is, in various embodiments, the valve prosthesis can be implanted without removing the native valve leaflets. - The
sizing device 10 may be used in connection with implantation of an expandable/contractible replacement heart valve of the type generally known in the art. Thesizing device 10 may be used, for example, in connection with any sutureless aortic valve prostheses, for example, including percutaneously delivered aortic valve prostheses. In various exemplary embodiments, thesizing device 10 is used in connection with implantation of any of the prosthetic valves disclosed in co-pending and commonly assigned U.S. patent application Ser. Nos. 11/066,346 and 11/352,021, the disclosures of which are incorporated herein by reference in their entireties. -
FIGS. 2A-2B are perspective views of the valve sizer ofFIG. 1 in deployed and undeployed configurations, respectively. As shown, the sizingdevice 10 includes amain body portion 24 supporting a measuringportion 28. As shown inFIG. 2A , the measuring portion orband 28 is disposed in an expanded configuration, in which the measuringband 28 has an effective diameter larger than that of the distal end of themain body portion 24, while inFIG. 2B , the measuringband 28 is disposed in a collapsed configuration, in which it has an effective diameter about equal to that of the distal end of themain body portion 24. This expandable/collapsible design facilitates delivery of the tool using standard minimally-invasive delivery techniques and instruments. This design also provides thedevice 10 with the ability to measure a wide variety of valve annuli, each having a distinct diameter or perimeter dimension. - As further shown in
FIGS. 2A-2B , themain body portion 24 includes anelongated support member 32, which couples an adjustable member orknob 34 at its proximal end to an adjustment mechanism 36 at its distal end. In various embodiments, a shaft or coupling rod (not shown) extends through an internal lumen in theelongated support member 32 and rotationally couples theadjustable knob 34 to the adjustment mechanism 36. In various embodiments, thesupport member 32 includes a linkage or plurality of linkages, which allow adjustment of the orientation and shape of the handle (e.g., both angularly and rotatably) relative to the adjustable portion 36. In various embodiments, thesupport member 32 may include a locking mechanism to allow the physician to lock the position of the support member when desired. In various embodiments, all or a portion of thesupport member 32 may be made flexible in addition to or in lieu of the inclusion of the linkages, thereby providing alternative or additional flexibility in orienting the adjustment mechanism 36 inside the valve annulus. - According to some embodiments, the
device 10 is configured such that the adjustment mechanism 36 responds to movement imparted on theadjustable knob 34. For example, during use, a physician could apply a rotational force having a desired magnitude to theadjustable knob 34. This force in-turn causes a corresponding rotation of theadjustment mechanism 34. This rotation of the adjustment mechanism causes deployment of the measuringband 28. According to other embodiments, as further explained below, the measuringband 28 is biased to an open or expanded position, such that it self-expands inside the valve annulus, which causes rotation of the adjustment mechanism 36, which in-turn causes rotation of theadjustable knob 34. In some embodiments, theadjustable knob 34 or the adjustment mechanism 36 include a latch or lock for retaining the measuring band in the collapsed configuration. The physician may then manipulate this latch or lack at an appropriate time, to allow the measuring band to deploy or expand. - An
annular member 38 is coupled near a proximal end of theelongated support member 32 adjacent theadjustable knob 34. The annular member orindicator 38 includesindicia 40 disposed circumferentially about the annular member. These indicia are configured to indicate a degree of deployment of the measuringband 28. In the embodiment ofFIGS. 2A and 2B , for example, theindicia 40 include various numbers representative of the diameter of the measuring band in millimeters. In other embodiments, theindicia 40 are configured to indicate an effective length (i.e., the length extending out of the adjustment mechanism 36) of the measuring band. Of course, one skilled in the art, will recognize that a wide variety of other indicia may be useful in connection with a valve sizing procedure. -
FIGS. 3A-3C show various views of the adjustment mechanism 36 located at a distal end of the sizingdevice 10. In the configuration shown inFIGS. 3A-3C , for purposes of illustration only, the measuringband 28 has been partially disassembled from the adjustment mechanism 36. These figures to not show a configuration obtained by the measuringband 28 during actual use of the sizingdevice 10. As shown inFIG. 3A , the adjustment mechanism 36 includes acylindrical holder 44, the measuringband 28, and ahub portion 45. As shown, thecylindrical holder 44, which has a proximal end 46 and a distal end 48, is structurally separate from theelongated support member 32. In such embodiments, the proximal end 46 of thecylindrical holder 44 is adapted to couple to a distal end of the sizingdevice 10, such as for example by use of an interference fit with a distal portion of thesupport member 32. According to other embodiments, the cylindrical holder is an integrally formed portion of the distal end of theelongated support member 32. In either case, the cylindrical holder is fixed both longitudinally and rotationally during use of the device. - The
cylindrical holder 44 includes an opening orslot 52 extending longitudinally through a portion thereof. In some embodiments, theslot 52 extends along the entire length of theholder 44 from the proximal end 46 to the distal end 48. Adjacent theslot 52 is a coupling edge 54. As shown, theholder 44 also includes an annular lip 56 located at the distal end 48. In other embodiments, theholder 44 includes an annular lip at the proximal end 46 as well. Thecylindrical holder 44 defines an internal, central chamber or bore 60. - As shown in
FIGS. 3A-3C , the measuringband 28 includes an elongated portion extending from aproximal end 64 to a distal end 68. Theproximal end 64 is coupled to theholder 44 at or near the coupling edge 54. The distal end 68 of the measuringband 28 is coupled to thehub portion 45. As shown, thehub portion 45 includes a protrusion 72 defining aninternal engagement portion 76. The protrusion 72 andengagement portion 76 facilitation coupling of thehub portion 45 to the coupling rod, which extends from the adjustment mechanism 36 to the proximal end of the sizingdevice 10. The measuringband 28 may be made from any material having suitable physical characteristics. In various embodiments, theband 28 is made from a biocompatible polymeric or metallic material. In embodiments where theband 28 is self-expandable, the band is made from a polymer or metal having shape memory and/or superelastic properties. Once such class of superelastic materials well known in the art are nickel-titanium alloys, such as nitinol. According to one exemplary embodiment, the measuring band has a length of between about 150 and 190 mm, a height of between about 1 and 10 mm, and a thickness of about 0.05 and 2 mm. In other embodiments, the measuring band may include other dimensions as appropriate for use of the ban in measuring the circumference of a valve annulus. - In some embodiments, the measuring
band 28 includes a longitudinally extending radiopaque portion to facilitate visualization of the measuring band during use of the device. In other embodiments, the longitudinally extending edge (or edges) of the measuringband 28 are tapered or otherwise softened, to help minimize trauma to thevalve annulus 14 or adjacent tissue during a sizing procedure. - According to various embodiments the
hub portion 45 and the measuringband 28 are removable from theholder 44. In these embodiments, the measuringband 28 andhub portion 45 of the sizingdevice 10 are readily disposable after use, while the remaining portions of the device may be sterilized and reused by the physician. In these embodiment, for example, the measuring band can be removed by unwinding and expanding the measuring band and then manipulating the measuring band around the distal annular lip 56. The measuringband 28 andhub 45 can then be slid distally out of theholder 44 for disposal. A new,sterile measuring band 28 andhub 45 can then be inserted into theholder 44, and theengagement portion 76 coupled to the coupling rod. -
FIGS. 4A-4B show the adjustment mechanism 36 in an assembled, collapsed configuration. For illustration purposes only, thecylindrical holder 44 is shown separated from theelongated support member 32. As shown inFIGS. 4A-4B , the measuringband 28 is wound about theholder 44 in a clockwise direction, such that it extends along an outer surface of theholder 44, extends through theslot 52, and extends along an internal surface of theholder 44 in the central chamber 60. Theproximal end 64 of the measuringband 28 is attached at or near the coupling edge of theholder 44, and the distal end 68 of the measuring band is coupled to thehub portion 45. In this configuration, the measuring band has a minimal effective diameter (D1), which facilitates access to thevalve annulus 14 using standard minimally invasive access techniques and instruments. In the embodiment shown, the annular lip 56 extends radially outward from the holder a distance about equal to the thickness of the measuringband 28. In this embodiment, the leading (distal) edge of the measuring band is thus covered or protected by the annular lip 56. As shown inFIGS. 4A-4B , in the assembled configuration, thehub portion 45 is located inside the central chamber 60, with portions of the measuringband 28 wound thereabout. -
FIGS. 5A-5B show the adjustment mechanism 36 in an assembled, expanded configuration. Again, for illustration purposes, thecylindrical holder 44 is shown separated from theelongated support member 32. As shown, in the expanded configuration, the measuringband 28 is at least partially unwound, which results in an the measuringband 28 defining an expanded effective diameter (D2). As shown, theproximal portion 64 of the measuringband 28 remains attached to theholder 44, and the distal portion 68 remains attached to thehub portion 45. Thehub portion 45, however, has rotated in the direction indicated by the arrow inFIG. 5B , to allow the measuring band to extend out through theslot 52 and away from theholder 44. The effective length (i.e., the length extending out from the holder 44) corresponds to an amount of rotation of thecentral hub 45. As the hub rotates in a counter-clockwise direction, the measuring band expands outwardly from theholder 44, and as the hub rotates in a clockwise direction, the measuring band contracts towards theholder 44. In the most expanded configuration, thehub portion 45 remains inside theholder 44, but all or nearly all portions of the measuringband 28 have extended out through theslot 52. -
FIGS. 6A-6B show schematic sectional views of a distal end of the sizingdevice 10, which has been placed at an intra-annular location by the implanting physician. In the illustrated embodiment, thenative valve annulus 14 is not precisely cylindrical in cross section, but instead has a slightly trigonal sectional configuration. While the sizingdevice 10 of the present invention is well suited to measure a diameter or perimeter dimension of a cylindrical annulus, it is also well suited to measure the effective diameter or perimeter of a non-cylindrical valve annulus. Likewise, the device of the present invention is able to measure the perimeter of a valve annulus that includes calcification or other imperfections. - As shown in
FIG. 6A , the physician has located the adjustment mechanism 36 of the sizingdevice 10 inside the valve annulus, with the measuringband 28 in a contracted configuration. Next, the physician activates the adjustment mechanism 36 to enable the measuringband 28 to expand radially outward into contact with an internal surface of the valve annulus, as shown inFIG. 6B . According to various embodiments, the materials and dimensions of the measuringband 28 are selected to enable the band to readily expand outward and to substantially or entirely conform to the inner surface of the valve annulus. - According to some embodiments, the measuring
band 28 is unwound and expanded manually by the implanting physician. In these embodiments, the physician can expand and contract the measuring band by turning theadjustable knob 34. As explained above, theadjustable knob 34 is coupled (using, for example, a coupling rod) to the adjustment mechanism 36. Specifically, in various embodiments, the adjustable knob is coupled to thehub portion 45 of the adjustment mechanism. By turning theadjustable knob 34, the physician can effect a corresponding rotation of the hub portion, which in turn will effect an unwinding or unfurling of the measuringband 28. In these embodiments, the physician can rotate theadjustable knob 34 until she feels a certain degree of resistance, which corresponds to an amount of radial force applied byvalve annulus 14 against the measuringband 28. When the physician determines that she has caused an appropriate amount of force against the valve annulus, she can read theindicia 40 on the handle, which indicates the corresponding diameter or effective length of the measuringband 28. - In some embodiments, the sizing
device 10 includes a torque limiting device of the type known in the art. This torque limiter is placed between theknob 34 and the adjustment mechanism 36 and prevents the physician from applying an excessive force of a magnitude that could cause damage to the native valve annulus. - According to other embodiments, the measuring
band 28 is made from a superelastic material, which is biased to the fully expanded configuration. In one such exemplary embodiment, the measuring band is made from a material and has dimensions selected such that the measuring band will expand to a diameter greater than the largest expected valve annulus diameter. In one embodiment, for example, the measuringband 28 is biased to an expanded configuration (such as that shown inFIG. 5A ) having an effective diameter of greater than about 26 mm. In these embodiments, the material and dimensions of the measuringband 28 are also selected such that the measuring band generates an outward radial force against the inward-facing surface of thevalve annulus 14, which radial force approximates that radial force generated by the self-expandable prosthetic valve to be implanted in thevalve annulus 14. In some embodiments, the radial force generates by the measuringband 28 differs from the radial force generated by the prosthetic heart valve by not more than 10 percent. In other embodiments, the radial forces differ by not more than 5 percent. In still other embodiments, the radial forces differ by not more than 2 percent. - As will be apparent to the skilled artisan, by setting the self-expanding radial force of the measuring
band 28 approximately equal to the radial force generated by the prosthetic valve to be implanted, the sizingdevice 10 may obtain a more accurate measure of the internal dimensions of the valve annulus upon implantation of the prosthetic valve. The implantation of a self-expanding prosthetic valve may result in a change in shape and/or size of thevalve annulus 14, which changes will be detected by the sizingdevice 10 of the present invention. In these embodiments, the implanting physician allows the measuring band to expand inside the valve annulus and then reads the corresponding dimensional information from theindicia 40 disposed on theannular member 38. - According to various embodiments, the measuring
band 28 is sufficiently flexible to allow it to substantially conform to the internal surface of thevalve annulus 14. In some embodiments, for example, the measuringband 28 is able to readily take on a radius of curvature of less than about 2 mm. This flexibility allows the measuring band to substantially conform to valve annuli having irregular shapes. -
FIG. 7 is a schematic view illustrating asizing device 100 according to another embodiment of the present invention. As shown inFIG. 7 , thedevice 100 includes amain body portion 104 and a measuringportion 108. Thedevice 100 is shown in one possible operating configuration with the main body portion or handle 104 extending through a vessel downstream from the valve and the measuring portion located generally insider the valve annulus. InFIG. 7 , the measuringportion 108 is shown in a deployed or expanded configuration, such that the measuringportion 108 is in contact with an inner wall or surface of the valve annulus. -
FIG. 8 shows a partial sectional view of thesizing device 100. As shown, the main body portion includes anelongated support member 110, which couples anadjustable member 112 to the measuringportion 108. As further shown inFIG. 8 , the main body portion houses or contains a torque member or rod 116, which is coupled to theadjustable member 112 at a proximal end and includes a threadeddistal end 118. The threads of the rod 116 engage corresponding threads of a tapered element 122, such that a rotation applied to theadjustable member 112 causes rotation of the rod 116, which in turn causes longitudinal motion of the tapered element 122 with respect to themain body portion 104. As the tapered element is moved towards themain body portion 104, it slides along an interior surface of the measuringportion 108, which in turn causes the measuring portion to expand outwardly. Accordingly, a user of thedevice 100 can apply a torque to theadjustable member 112 to cause expansion or deployment of the measuringportion 108, until the measuring portion contacts the interior surface of the annulus. In some embodiments, the adjustable member includes an associates scale which is configured to indicate the corresponding diameter or circumference of the measuringportion 108. - According to other embodiments, the measuring
portion 108 is self-expanding. In some such embodiments, the measuringportion 108 is expanded in an unbiased position, such that it defines an overall diameter that is slightly larger than a diameter of the target valve annulus. In exemplary embodiments, the measuringportion 108 is made from a polymer or metal having shape memory and/or superelastic properties. Once such class of superelastic materials well known in the art are nickel-titanium alloys, such as nitinol. In some embodiments, the measuring portion is held in a collapsed or compressed configuration by a sheath or tube disposed over theelongated support member 110. The measuringportion 108 is then deployed (i.e., allowed to self-expand) by retracting the sheath and allowing the measuring portion to expand radially into contact with an inner surface of a valve annulus. In such embodiments, the elongated support member may include indicia which are disposed axially along the shaft such that the indicia correspond to a diameter or circumference of the measuringportion 108. In this fashion, the indicia will provide the user with an indication of the diameter or circumference of the target valve annulus. -
FIG. 9 shows a schematic view of an exemplary embodiment of the measuringportion 108. As shown inFIG. 9 , in this embodiment, the measuring portion includes a plurality of measuring elements or petals 120A to 120F. In various exemplary embodiments, the measuringportion 108 may include more or fewer petals 120, as appropriate for measuring the desired valve annulus. As shown inFIG. 9 , the petals 120 are expandable (as described above) from a collapsed configuration to and expanded configuration. An exemplary expanded configuration is shown by the elements or petals marked 120A′ to 120F′. -
FIG. 10 is a flowchart illustrating one exemplary technique 200 for using thesizing device FIG. 7 , in some embodiments, the physician first removes the native anatomical valve leaflets from the valve (block 210). The physician then, in some embodiments, debrides or otherwise smoothes out the tissue at the valve annulus (block 220). The physician then introduces the sizingdevice 10 of the present invention to an intra-annular location and activates or releases the measuring band until it applies an outwardly directed force similar to that applied by the prosthetic valve to be implanted (block 230). While this force is being applied to the valve annulus, the physician reads an estimate of the annulus diameter or perimeter from the device (block 240). Based on this estimate of the annulus dimension, the physician selects an appropriately sized prosthetic valve (block 250). The physician then implants the appropriately sized valve at the native valve annulus (block 260). - Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.
Claims (16)
1. A method of measuring an internal dimension of a native cardiac valve annulus of a patient, the valve annulus having an interior surface, the method comprising:
providing a valve annulus measuring device having a main body portion and an expandable measuring portion, the main body portion including an elongated support member that couples an adjustable member to the expandable measuring portion, the measuring portion being radially expandable between a collapsed configuration and an expanded configuration, wherein a rotation applied to the adjustable member causes expansion of the measuring portion;
inserting the valve annulus measuring device in the collapsed configuration into the patient so that the measuring portion is positioned within the valve annulus; and
rotating the adjustable member until the measuring portion contacts the interior surface of the valve annulus indicating that the measuring portion has fully engaged with the interior surface of the valve annulus.
2. The method of claim 1 , wherein the adjustable member includes an associates scale which is configured to indicate a corresponding diameter or circumference of the valve annulus.
3. The method of claim 1 , wherein the measuring device includes indicia to indicate a diameter or circumference of the internal dimension of the valve annulus.
4. The method of claim 1 , wherein the measuring portion comprises a plurality of measuring petals that are radially expandable between the collapsed configuration and the expanded configuration.
5. A method of measuring an internal dimension of a native cardiac valve annulus of a patient, the valve annulus having an interior surface, the method comprising:
providing a valve annulus measuring device having a main body portion and an expandable measuring portion, the main body portion including an elongated support member that couples an adjustable member to the expandable measuring portion, the measuring portion being radially expandable between a collapsed configuration and an expanded configuration, the main body portion further including a rod that is coupled to the adjustable member at a proximal end and includes a threaded distal end, wherein threads of the rod engage corresponding threads of a tapered element such that a rotation applied to the adjustable member causes rotation of the rod which in turn causes longitudinal motion of the tapered element proximally with respect to the main body portion and along an interior surface of the measuring portion, which causes expansion of the measuring portion;
inserting the valve annulus measuring device in the collapsed configuration into the patient so that the measuring portion is positioned within the valve annulus; and
rotating the adjustable member until the measuring portion contacts the interior surface of the valve annulus indicating that the measuring portion has fully engaged with the interior surface of the valve annulus.
6. The method of claim 5 , wherein the adjustable member includes an associates scale which is configured to indicate a corresponding diameter or circumference of the valve annulus.
7. The method of claim 5 , wherein the measuring device includes indicia to indicate a diameter or circumference of the internal dimension of the valve annulus.
8. The method of claim 5 , wherein the measuring portion comprises a plurality of measuring petals that are radially expandable between the collapsed configuration and the expanded configuration.
9. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising:
a main body portion; and
an expandable measuring portion being radially expandable between a collapsed configuration and an expanded configuration;
wherein the expandable measuring portion includes a plurality of elongated measuring elements, each of the plurality of elongated measuring elements having a first end coupled to the main body portion and a second end adapted to move radially outward; and
wherein the main body portion includes an elongated support member that couples an adjustable member to the expandable measuring portion, and wherein a rotation applied to the adjustable member causes expansion of the measuring portion such that a second end of each of the plurality of elongated measuring elements moves radially outward.
10. The device of claim 9 , wherein the main body portion further includes a rod that is coupled to the adjustable member at a proximal end and includes a threaded distal end, wherein threads of the rod engage corresponding threads of a tapered element such that a rotation applied to the adjustable member causes rotation of the rod which in turn causes longitudinal motion of the tapered element proximally with respect to the main body portion and along an interior surface of the measuring portion, which causes expansion of the measuring portion.
11. The device of claim 9 , wherein the adjustable member includes an associates scale which is configured to indicate a corresponding diameter or circumference of the valve annulus.
12. The device of claim 9 , further comprising indicia to indicate a diameter or circumference of the internal dimension of the valve annulus.
13. The device of claim 9 , wherein the measuring portion comprises a plurality of measuring petals that are radially expandable between the collapsed configuration and the expanded configuration.
14. The device of claim 10 , wherein the adjustable member includes an associates scale which is configured to indicate a corresponding diameter or circumference of the valve annulus.
15. The device of claim 10 , further comprising indicia to indicate a diameter or circumference of the internal dimension of the valve annulus.
16. The device of claim 10 , wherein the measuring portion comprises a plurality of measuring petals that are radially expandable between the collapsed configuration and the expanded configuration.
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Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9149207B2 (en) | 2009-03-26 | 2015-10-06 | Sorin Group Usa, Inc. | Annuloplasty sizers for minimally invasive procedures |
US10702380B2 (en) | 2011-10-19 | 2020-07-07 | Twelve, Inc. | Devices, systems and methods for heart valve replacement |
US10702378B2 (en) | 2017-04-18 | 2020-07-07 | Twelve, Inc. | Prosthetic heart valve device and associated systems and methods |
US10709591B2 (en) | 2017-06-06 | 2020-07-14 | Twelve, Inc. | Crimping device and method for loading stents and prosthetic heart valves |
US10729541B2 (en) | 2017-07-06 | 2020-08-04 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
US10751173B2 (en) | 2011-06-21 | 2020-08-25 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
US10786352B2 (en) | 2017-07-06 | 2020-09-29 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
US10945835B2 (en) | 2011-10-19 | 2021-03-16 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US11197758B2 (en) | 2011-10-19 | 2021-12-14 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US11202704B2 (en) | 2011-10-19 | 2021-12-21 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US11452599B2 (en) | 2019-05-02 | 2022-09-27 | Twelve, Inc. | Fluid diversion devices for hydraulic delivery systems and associated methods |
Families Citing this family (40)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ITTO20040135A1 (en) | 2004-03-03 | 2004-06-03 | Sorin Biomedica Cardio Spa | CARDIAC VALVE PROSTHESIS |
ITTO20050074A1 (en) | 2005-02-10 | 2006-08-11 | Sorin Biomedica Cardio Srl | CARDIAC VALVE PROSTHESIS |
US20080262603A1 (en) * | 2007-04-23 | 2008-10-23 | Sorin Biomedica Cardio | Prosthetic heart valve holder |
US8006535B2 (en) | 2007-07-12 | 2011-08-30 | Sorin Biomedica Cardio S.R.L. | Expandable prosthetic valve crimping device |
US9848981B2 (en) | 2007-10-12 | 2017-12-26 | Mayo Foundation For Medical Education And Research | Expandable valve prosthesis with sealing mechanism |
EP2367505B1 (en) | 2008-09-29 | 2020-08-12 | Edwards Lifesciences CardiAQ LLC | Heart valve |
WO2010040009A1 (en) | 2008-10-01 | 2010-04-08 | Cardiaq Valve Technologies, Inc. | Delivery system for vascular implant |
US8834563B2 (en) | 2008-12-23 | 2014-09-16 | Sorin Group Italia S.R.L. | Expandable prosthetic valve having anchoring appendages |
EP2229884A1 (en) * | 2009-03-18 | 2010-09-22 | Contipi Ltd. | Device and method for fitting a pessary |
AU2010229764B2 (en) * | 2009-03-27 | 2015-05-07 | Mardil, Inc. | Intra-operative heart size measuring tool |
US8414644B2 (en) | 2009-04-15 | 2013-04-09 | Cardiaq Valve Technologies, Inc. | Vascular implant and delivery system |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
IT1400327B1 (en) | 2010-05-21 | 2013-05-24 | Sorin Biomedica Cardio Srl | SUPPORT DEVICE FOR VALVULAR PROSTHESIS AND CORRESPONDING CORRESPONDENT. |
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EP2486894B1 (en) | 2011-02-14 | 2021-06-09 | Sorin Group Italia S.r.l. | Sutureless anchoring device for cardiac valve prostheses |
ES2641902T3 (en) | 2011-02-14 | 2017-11-14 | Sorin Group Italia S.R.L. | Sutureless anchoring device for cardiac valve prostheses |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9345574B2 (en) * | 2011-12-09 | 2016-05-24 | Edwards Lifesciences Corporation | Force-based heart valve sizer |
US9277996B2 (en) * | 2011-12-09 | 2016-03-08 | Edwards Lifesciences Corporation | Force-based heart valve sizer |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US9801721B2 (en) * | 2012-10-12 | 2017-10-31 | St. Jude Medical, Cardiology Division, Inc. | Sizing device and method of positioning a prosthetic heart valve |
US20150351911A1 (en) * | 2013-01-25 | 2015-12-10 | Medtentia International Ltd Oy | A Medical Device And Method For Facilitating Selection Of An Annuloplasty Implant |
US10583002B2 (en) | 2013-03-11 | 2020-03-10 | Neovasc Tiara Inc. | Prosthetic valve with anti-pivoting mechanism |
US9149360B2 (en) | 2013-03-12 | 2015-10-06 | Edwards Lifesciences Corporation | Dynamic annuloplasty ring sizer |
US9681951B2 (en) | 2013-03-14 | 2017-06-20 | Edwards Lifesciences Cardiaq Llc | Prosthesis with outer skirt and anchors |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
FR3004917B1 (en) * | 2013-04-25 | 2016-06-10 | Bernard Pain | APPARATUS FOR MEASURING THE DIAMETER OF AN AORTIC VALVE |
WO2015013536A2 (en) * | 2013-07-24 | 2015-01-29 | Shifamed Holdings, Llc | Heart valve sizing |
DE102014114762B3 (en) * | 2014-10-10 | 2016-03-03 | Asanus Medizintechnik Gmbh | Aortic valve clamp and instrument set for aortic valve reconstruction |
TR201618240A2 (en) * | 2016-12-09 | 2017-01-23 | Ahmet Elibol | MEASUREMENT AND SIMULATION EQUIPMENT USED IN AORTIC LID PROTECTIVE ROOT REPLACEMENT SURGERY |
EP3691541A1 (en) | 2017-10-07 | 2020-08-12 | Sorin Group Italia S.r.l. | Bendable cardiac surgery instruments |
CN111565678B (en) | 2018-01-23 | 2023-07-07 | 爱德华兹生命科学公司 | Prosthetic valve holders, systems, and methods |
JP7074929B2 (en) | 2018-05-23 | 2022-05-24 | コーシム・ソチエタ・ア・レスポンサビリタ・リミタータ | Heart valve prosthesis holders, heart valve prosthesis storage devices, and crimp kits and methods |
JP7170127B2 (en) | 2018-05-23 | 2022-11-11 | コーシム・ソチエタ・ア・レスポンサビリタ・リミタータ | Loading system and associated loading method for implantable prostheses |
JP7109657B2 (en) | 2018-05-23 | 2022-07-29 | コーシム・ソチエタ・ア・レスポンサビリタ・リミタータ | heart valve prosthesis |
USD908874S1 (en) | 2018-07-11 | 2021-01-26 | Edwards Lifesciences Corporation | Collapsible heart valve sizer |
JP6484749B1 (en) * | 2018-10-25 | 2019-03-13 | 重之 尾崎 | Leaflet sizer |
EP4146070A4 (en) * | 2020-06-11 | 2024-06-12 | LSI Solutions, Inc. | Surgical sizer sound |
DE102021124499B3 (en) | 2021-09-22 | 2023-03-16 | Carl Zeiss Meditec Ag | measuring device |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5814098A (en) * | 1995-06-07 | 1998-09-29 | St. Jude Medical, Inc. | Adjustable sizing apparatus |
US5885031A (en) * | 1997-12-08 | 1999-03-23 | White; Claude | Mine roof bolt anchor |
US5984959A (en) * | 1997-09-19 | 1999-11-16 | United States Surgical | Heart valve replacement tools and procedures |
US20070151116A1 (en) * | 2005-07-12 | 2007-07-05 | Malandain Hugues F | Measurement instrument for percutaneous surgery |
Family Cites Families (113)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3363442A (en) * | 1965-05-25 | 1968-01-16 | North American Aviation Inc | Tube tapering device |
US3744140A (en) * | 1971-01-11 | 1973-07-10 | Abbott Lab | Circumference measuring device |
GB2083362B (en) | 1977-12-29 | 1982-11-24 | Yeshiva University Albert Eins | Disposable heart valve unit |
IT1208326B (en) | 1984-03-16 | 1989-06-12 | Sorin Biomedica Spa | CARDIAC VALVE PROSTHESIS PROVIDED WITH VALVES OF ORGANIC FABRIC |
US5042161A (en) * | 1985-10-07 | 1991-08-27 | Joseph Hodge | Intravascular sizing method and apparatus |
AT398276B (en) | 1989-05-31 | 1994-11-25 | Sorin Biomedica Spa | METHOD FOR PREPARING BIOLOGICAL IMPLANTATION MATERIAL |
IT1245750B (en) | 1991-05-24 | 1994-10-14 | Sorin Biomedica Emodialisi S R | CARDIAC VALVE PROSTHESIS, PARTICULARLY FOR REPLACING THE AORTIC VALVE |
US5505689A (en) | 1991-05-29 | 1996-04-09 | Origin Medsystems, Inc. | Propertioneal mechanical retraction apparatus |
US5522884A (en) * | 1993-02-19 | 1996-06-04 | Medtronic, Inc. | Holder for adjustable mitral & tricuspid annuloplasty rings |
US5360014A (en) * | 1993-11-10 | 1994-11-01 | Carbomedics, Inc. | Sizing apparatus for heart valve with supra annular suture ring |
US5489296A (en) * | 1993-12-17 | 1996-02-06 | Autogenics | Heart valve measurement tool |
US5698307A (en) * | 1994-02-04 | 1997-12-16 | Fabrite Laminating Corp. | Quadlaminate fabric for surgical gowns and drapes |
US5560487A (en) * | 1994-07-29 | 1996-10-01 | Carbomedics, Inc. | Holder and packaging for bioprosthetic heart valve |
US5776187A (en) * | 1995-02-09 | 1998-07-07 | St. Jude Medical, Inc. | Combined holder tool and rotator for a prosthetic heart valve |
CA2239907A1 (en) | 1995-06-07 | 1996-12-19 | Michi E. Garrison | Less invasive devices and methods for treatment of cardiac valves |
US5626604A (en) | 1995-12-05 | 1997-05-06 | Cordis Corporation | Hand held stent crimping device |
US5693066A (en) * | 1995-12-21 | 1997-12-02 | Medtronic, Inc. | Stent mounting and transfer device and method |
WO1997024989A1 (en) | 1996-01-04 | 1997-07-17 | Shelhigh, Inc. | Heart valve prosthesis and method for making same |
EP0873094B1 (en) * | 1996-01-05 | 1999-06-30 | Baxter International Inc. | Sizing obturator for prosthetic aortic valves |
US6402780B2 (en) * | 1996-02-23 | 2002-06-11 | Cardiovascular Technologies, L.L.C. | Means and method of replacing a heart valve in a minimally invasive manner |
US5672169A (en) * | 1996-04-10 | 1997-09-30 | Medtronic, Inc. | Stent mounting device |
US5885228A (en) * | 1996-05-08 | 1999-03-23 | Heartport, Inc. | Valve sizer and method of use |
US5669919A (en) * | 1996-08-16 | 1997-09-23 | Medtronic, Inc. | Annuloplasty system |
US6123712A (en) * | 1996-08-23 | 2000-09-26 | Scimed Life Systems, Inc. | Balloon catheter with stent securement means |
US5800531A (en) * | 1996-09-30 | 1998-09-01 | Baxter International Inc. | Bioprosthetic heart valve implantation device |
US5972016A (en) * | 1997-04-22 | 1999-10-26 | Advanced Cardiovascular Systems, Inc. | Stent crimping device and method of use |
US5810873A (en) * | 1997-07-15 | 1998-09-22 | Advanced Cardiovascular Systems, Inc. | Stent crimping tool and method of use |
WO1999016499A1 (en) * | 1997-10-01 | 1999-04-08 | Boston Scientific Corporation | Dilation systems and related methods |
US6769161B2 (en) | 1997-10-16 | 2004-08-03 | Scimed Life Systems, Inc. | Radial stent crimper |
US6024737A (en) * | 1998-02-25 | 2000-02-15 | Advanced Cardiovascular Systems, Inc. | Stent crimping device |
US6202272B1 (en) | 1998-02-26 | 2001-03-20 | Advanced Cardiovascular Systems, Inc. | Hand-held stent crimping device |
US5931851A (en) | 1998-04-21 | 1999-08-03 | Advanced Cardiovascular Systems, Inc. | Method and apparatus for rubber-tube crimping tool with premount stent |
US6009614A (en) | 1998-04-21 | 2000-01-04 | Advanced Cardiovascular Systems, Inc. | Stent crimping tool and method of use |
US6141855A (en) | 1998-04-28 | 2000-11-07 | Advanced Cardiovascular Systems, Inc. | Stent crimping tool and method of use |
US6019739A (en) * | 1998-06-18 | 2000-02-01 | Baxter International Inc. | Minimally invasive valve annulus sizer |
US6092273A (en) | 1998-07-28 | 2000-07-25 | Advanced Cardiovascular Systems, Inc. | Method and apparatus for a stent crimping device |
US6051002A (en) | 1998-10-09 | 2000-04-18 | Advanced Cardiovascular Systems, Inc. | Stent crimping device and method of use |
US5951540A (en) * | 1998-10-22 | 1999-09-14 | Medtronic, Inc. | Device and method for mounting stents |
US6125523A (en) | 1998-11-20 | 2000-10-03 | Advanced Cardiovascular Systems, Inc. | Stent crimping tool and method of use |
US6493608B1 (en) | 1999-04-07 | 2002-12-10 | Intuitive Surgical, Inc. | Aspects of a control system of a minimally invasive surgical apparatus |
EP1600124B1 (en) * | 1999-01-22 | 2008-01-02 | Gore Enterprise Holdings, Inc. | Method for compacting an endoprosthesis |
DE60040839D1 (en) * | 1999-01-26 | 2009-01-02 | Edwards Lifesciences Corp | MEASURING TEMPLATES FOR ANATOMIC OPENINGS |
US6424885B1 (en) | 1999-04-07 | 2002-07-23 | Intuitive Surgical, Inc. | Camera referenced control in a minimally invasive surgical apparatus |
US7563267B2 (en) * | 1999-04-09 | 2009-07-21 | Evalve, Inc. | Fixation device and methods for engaging tissue |
WO2000064382A2 (en) * | 1999-04-28 | 2000-11-02 | St. Jude Medical, Inc. | Aortic heart valve prosthesis sizer and marker |
DE29911694U1 (en) | 1999-07-06 | 1999-08-26 | Jostra Medizintechnik Ag | Universal measuring template for annuloplasty rings |
US6350281B1 (en) * | 1999-09-14 | 2002-02-26 | Edwards Lifesciences Corp. | Methods and apparatus for measuring valve annuluses during heart valve-replacement surgery |
US6352547B1 (en) | 1999-09-22 | 2002-03-05 | Scimed Life Systems, Inc. | Stent crimping system |
US6387117B1 (en) * | 1999-09-22 | 2002-05-14 | Scimed Life Systems, Inc. | Stent crimping system |
US6360577B2 (en) * | 1999-09-22 | 2002-03-26 | Scimed Life Systems, Inc. | Apparatus for contracting, or crimping stents |
US6678962B1 (en) * | 1999-11-17 | 2004-01-20 | Cardiomend Llc | Device and method for assessing the geometry of a heart valve |
US6598307B2 (en) * | 1999-11-17 | 2003-07-29 | Jack W. Love | Device and method for assessing the geometry of a heart valve |
US6481262B2 (en) * | 1999-12-30 | 2002-11-19 | Advanced Cardiovascular Systems, Inc. | Stent crimping tool |
CN1806775A (en) * | 2000-01-14 | 2006-07-26 | 维亚科公司 | Tissue annuloplasty band and apparatus and method for fashioning, sizing and implanting the same |
US6309383B1 (en) * | 2000-01-20 | 2001-10-30 | Isostent, Inc. | Stent crimper apparatus with radiation shied |
US6454799B1 (en) * | 2000-04-06 | 2002-09-24 | Edwards Lifesciences Corporation | Minimally-invasive heart valves and methods of use |
US6510722B1 (en) * | 2000-05-10 | 2003-01-28 | Advanced Cardiovascular Systems, Inc. | Stent crimping tool for producing a grooved crimp |
US6629350B2 (en) * | 2000-06-08 | 2003-10-07 | Tom Motsenbocker | Stent crimping apparatus and method |
AU2001271667A1 (en) * | 2000-06-30 | 2002-01-14 | Viacor Incorporated | Method and apparatus for performing a procedure on a cardiac valve |
IT1320232B1 (en) | 2000-07-11 | 2003-11-26 | Sorin Biomedica Cardio Spa | PROCEDURE FOR COUPLING AN ANGIOPLASTIC STENT WITH AN ADDITIONAL INSERTION ELEMENT AND SO ACCOMPANYING FORMAT. |
WO2002011646A1 (en) | 2000-08-03 | 2002-02-14 | Fortimedix B.V. | Device for crimping a stent onto a catheter delivery system |
EP1179322A3 (en) * | 2000-08-09 | 2004-02-25 | BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin | Stent crimping method and device |
US6955689B2 (en) * | 2001-03-15 | 2005-10-18 | Medtronic, Inc. | Annuloplasty band and method |
CA2441946C (en) * | 2001-03-26 | 2010-02-23 | Machine Solutions, Inc. | Balloon folding technology |
FR2824765B1 (en) | 2001-05-16 | 2003-09-26 | Mg3 | DEVICE FOR ASSEMBLING BY CONNECTION OF CONNECTING PARTS ON MEANS TO BE ASSEMBLED |
US6676684B1 (en) | 2001-09-04 | 2004-01-13 | Intuitive Surgical, Inc. | Roll-pitch-roll-yaw surgical tool |
US6893460B2 (en) * | 2001-10-11 | 2005-05-17 | Percutaneous Valve Technologies Inc. | Implantable prosthetic valve |
US7189258B2 (en) * | 2002-01-02 | 2007-03-13 | Medtronic, Inc. | Heart valve system |
DE20205557U1 (en) | 2002-04-10 | 2002-07-04 | Weidmueller Interface | crimper |
US6966924B2 (en) * | 2002-08-16 | 2005-11-22 | St. Jude Medical, Inc. | Annuloplasty ring holder |
RU2005108673A (en) * | 2002-08-29 | 2006-01-20 | Митралсолюшнз, Инк. (Us) | IMPLANTED DEVICES FOR REGULATING THE INTERNAL CIRCLE OF ANATOMIC HOLE OR LIGHT |
US7152452B2 (en) * | 2002-12-26 | 2006-12-26 | Advanced Cardiovascular Systems, Inc. | Assembly for crimping an intraluminal device and method of use |
US20040193259A1 (en) * | 2003-03-25 | 2004-09-30 | Shlomo Gabbay | Sizing apparatus for cardiac prostheses and method of using same |
US7510573B2 (en) * | 2003-03-25 | 2009-03-31 | Shlomo Gabbay | Sizing apparatus |
US7367984B2 (en) * | 2003-05-07 | 2008-05-06 | Medtronic, Inc. | Methods and apparatus for sizing fresh donor heart valves |
US20040225356A1 (en) * | 2003-05-09 | 2004-11-11 | Frater Robert W. | Flexible heart valve |
US7007396B2 (en) * | 2003-05-29 | 2006-03-07 | Plc Medical Systems, Inc. | Replacement heart valve sizing device |
US7258698B2 (en) * | 2003-10-17 | 2007-08-21 | Medtronic, Inc. | Prosthetic heart valve sizer assembly with flexible sizer body |
JP4956192B2 (en) * | 2003-11-10 | 2012-06-20 | マシーン ソリューションズ インコーポレイテッド | Apparatus for measuring radial expansion force and method for measuring radial expansion force |
US7186265B2 (en) * | 2003-12-10 | 2007-03-06 | Medtronic, Inc. | Prosthetic cardiac valves and systems and methods for implanting thereof |
US7316147B2 (en) * | 2004-01-29 | 2008-01-08 | Boston Scientific Scimed, Inc. | Apparatuses for crimping and loading of intraluminal medical devices |
US8206439B2 (en) * | 2004-02-23 | 2012-06-26 | International Heart Institute Of Montana Foundation | Internal prosthesis for reconstruction of cardiac geometry |
US7225518B2 (en) | 2004-02-23 | 2007-06-05 | Boston Scientific Scimed, Inc. | Apparatus for crimping a stent assembly |
ITTO20040135A1 (en) * | 2004-03-03 | 2004-06-03 | Sorin Biomedica Cardio Spa | CARDIAC VALVE PROSTHESIS |
DE102004019254B8 (en) | 2004-04-16 | 2005-11-03 | Qualimed Innovative Medizinprodukte Gmbh | Device for reducing the diameter of a stent |
US7143625B2 (en) * | 2004-04-16 | 2006-12-05 | Boston Scientific Scimed, Inc. | Stent crimper |
US7021114B2 (en) * | 2004-04-16 | 2006-04-04 | Boston Scientific Scimed, Inc. | Stent crimper |
US20050267529A1 (en) * | 2004-05-13 | 2005-12-01 | Heber Crockett | Devices, systems and methods for tissue repair |
JP5242159B2 (en) * | 2004-06-16 | 2013-07-24 | マシーン ソリューションズ インコーポレイテッド | Tissue prosthesis processing technology |
ITTO20050074A1 (en) | 2005-02-10 | 2006-08-11 | Sorin Biomedica Cardio Srl | CARDIAC VALVE PROSTHESIS |
US7316148B2 (en) | 2005-02-15 | 2008-01-08 | Boston Scientific Scimed, Inc. | Protective sheet loader |
FR2882916B1 (en) * | 2005-03-14 | 2007-06-15 | Assist Publ Hopitaux De Paris | DEVICE FOR MEASURING THE DIAMETER OF AN AORTIC PANEL |
EP1890639A1 (en) | 2005-04-29 | 2008-02-27 | Arterial Remodelling Technologies Inc. | Stent crimping |
US7681430B2 (en) | 2005-05-25 | 2010-03-23 | Boston Scientific Scimed, Inc. | Method and apparatus for reducing a stent |
JP2008547167A (en) | 2005-06-23 | 2008-12-25 | シュロニガー ホールディング アーゲー | A crimping machine that performs various crimping and pressing processes, especially for cable assemblies |
US8790396B2 (en) * | 2005-07-27 | 2014-07-29 | Medtronic 3F Therapeutics, Inc. | Methods and systems for cardiac valve delivery |
US7530253B2 (en) * | 2005-09-09 | 2009-05-12 | Edwards Lifesciences Corporation | Prosthetic valve crimping device |
US7453227B2 (en) | 2005-12-20 | 2008-11-18 | Intuitive Surgical, Inc. | Medical robotic system with sliding mode control |
US9717468B2 (en) * | 2006-01-10 | 2017-08-01 | Mediguide Ltd. | System and method for positioning an artificial heart valve at the position of a malfunctioning valve of a heart through a percutaneous route |
US8486082B2 (en) * | 2006-12-13 | 2013-07-16 | Replication Medical, Inc. | Apparatus for dimensioning circumference of cavity for introduction of a prosthetic implant |
US8470024B2 (en) | 2006-12-19 | 2013-06-25 | Sorin Group Italia S.R.L. | Device for in situ positioning of cardiac valve prosthesis |
US8070799B2 (en) | 2006-12-19 | 2011-12-06 | Sorin Biomedica Cardio S.R.L. | Instrument and method for in situ deployment of cardiac valve prostheses |
WO2008089365A2 (en) | 2007-01-19 | 2008-07-24 | The Cleveland Clinic Foundation | Method for implanting a cardiovascular valve |
US20080262603A1 (en) * | 2007-04-23 | 2008-10-23 | Sorin Biomedica Cardio | Prosthetic heart valve holder |
US8006535B2 (en) * | 2007-07-12 | 2011-08-30 | Sorin Biomedica Cardio S.R.L. | Expandable prosthetic valve crimping device |
US7979618B2 (en) * | 2007-07-12 | 2011-07-12 | Samsung Electronics Co., Ltd. | Image forming apparatus and control method thereof |
US8114154B2 (en) | 2007-09-07 | 2012-02-14 | Sorin Biomedica Cardio S.R.L. | Fluid-filled delivery system for in situ deployment of cardiac valve prostheses |
US8808367B2 (en) | 2007-09-07 | 2014-08-19 | Sorin Group Italia S.R.L. | Prosthetic valve delivery system including retrograde/antegrade approach |
US9848981B2 (en) | 2007-10-12 | 2017-12-26 | Mayo Foundation For Medical Education And Research | Expandable valve prosthesis with sealing mechanism |
US20090192602A1 (en) | 2008-01-25 | 2009-07-30 | Medtronic, Inc. | Deformable Sizer and Holder Devices for Minimally Invasive Cardiac Surgery |
ATE554731T1 (en) | 2008-05-16 | 2012-05-15 | Sorin Biomedica Cardio Srl | ATRAAUMATIC PROSTHETIC HEART VALVE PROSTHESIS |
US8728012B2 (en) * | 2008-12-19 | 2014-05-20 | St. Jude Medical, Inc. | Apparatus and method for measuring blood vessels |
ES2543460T3 (en) * | 2009-03-26 | 2015-08-19 | Sorin Group Usa, Inc. | Annuloplasty sizing devices for minimally invasive interventions |
-
2010
- 2010-03-18 US US12/727,098 patent/US8715207B2/en active Active
-
2014
- 2014-03-22 US US14/222,598 patent/US20140207011A1/en not_active Abandoned
-
2017
- 2017-02-15 US US15/433,970 patent/US9918841B2/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5814098A (en) * | 1995-06-07 | 1998-09-29 | St. Jude Medical, Inc. | Adjustable sizing apparatus |
US5984959A (en) * | 1997-09-19 | 1999-11-16 | United States Surgical | Heart valve replacement tools and procedures |
US5885031A (en) * | 1997-12-08 | 1999-03-23 | White; Claude | Mine roof bolt anchor |
US20070151116A1 (en) * | 2005-07-12 | 2007-07-05 | Malandain Hugues F | Measurement instrument for percutaneous surgery |
Cited By (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9149207B2 (en) | 2009-03-26 | 2015-10-06 | Sorin Group Usa, Inc. | Annuloplasty sizers for minimally invasive procedures |
US10751173B2 (en) | 2011-06-21 | 2020-08-25 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
US11712334B2 (en) | 2011-06-21 | 2023-08-01 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
US11523900B2 (en) | 2011-06-21 | 2022-12-13 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
US11628063B2 (en) | 2011-10-19 | 2023-04-18 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US10702380B2 (en) | 2011-10-19 | 2020-07-07 | Twelve, Inc. | Devices, systems and methods for heart valve replacement |
US11826249B2 (en) | 2011-10-19 | 2023-11-28 | Twelve, Inc. | Devices, systems and methods for heart valve replacement |
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US12016772B2 (en) | 2017-07-06 | 2024-06-25 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
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Also Published As
Publication number | Publication date |
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US20170156866A1 (en) | 2017-06-08 |
US8715207B2 (en) | 2014-05-06 |
US20100249661A1 (en) | 2010-09-30 |
US9918841B2 (en) | 2018-03-20 |
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