US20110022165A1 - Introducer for prosthetic heart valve - Google Patents

Introducer for prosthetic heart valve Download PDF

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Publication number
US20110022165A1
US20110022165A1 US12/839,194 US83919410A US2011022165A1 US 20110022165 A1 US20110022165 A1 US 20110022165A1 US 83919410 A US83919410 A US 83919410A US 2011022165 A1 US2011022165 A1 US 2011022165A1
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United States
Prior art keywords
introducer
body
sutures
valve
gap
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Abandoned
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US12/839,194
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Travis Z. Oba
Louis A. Campbell
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Edwards Lifesciences Corp
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Edwards Lifesciences Corp
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Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Priority to US12/839,194 priority patent/US20110022165A1/en
Assigned to EDWARDS LIFESCIENCES CORPORATION reassignment EDWARDS LIFESCIENCES CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CAMPBELL, LOUIS A., OBA, TRAVIS
Publication of US20110022165A1 publication Critical patent/US20110022165A1/en
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3423Access ports, e.g. toroid shape introducers for instruments or hands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/243Deployment by mechanical expansion
    • A61F2/2433Deployment by mechanical expansion using balloon catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3439Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3423Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3425Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports

Abstract

The present disclosure concerns embodiments of an introducer that is adapted to facilitate insertion of a prosthetic device, such as a prosthetic heart valve, into a patient's vasculature. In one embodiment, the introducer comprises an elongated body defining a central lumen extending between distal and proximal ends of the body. The introducer body can also have a longitudinally extending gap extending along the length of the body between the distal end proximal ends. The gap in the introducer allows a user to place the introducer around implant sutures by passing the sutures through the gap and into the central lumen. Similarly, the gap allows the introducer to be easily removed from the sutures and/or a delivery device by passing them outwardly through the gap.

Description

    RELATED APPLICATION DATA
  • The present application claims priority under 35 U.S.C. §119(e) to U.S. provisional application No. 61/228,072 filed Jul. 23, 2009.
  • FIELD
  • The present invention pertains to an introducer that can be used to facilitate implantation of a prosthetic heart valve.
  • BACKGROUND
  • Prosthetic heart valves have been used for many years to treat cardiac valvular disorders. The native heart valves (such as the aortic, pulmonary, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital, inflammatory, or infectious conditions. Such conditions can eventually lead to serious cardiovascular compromise or death.
  • When a native valve is replaced, surgical implantation of a prosthetic valve typically requires an open-chest surgery during which the heart is stopped and patient placed on cardiopulmonary bypass (a so-called “heart-lung machine”). In one common surgical procedure, an incision is made in the aorta and the diseased native valve leaflets are excised. An array of implant sutures are secured around the periphery of the native valve, and the opposite ends of the sutures are pulled through the incision and then threaded through the sewing ring of the prosthetic valve. The prosthetic valve is then “parachuted” down the array of sutures until it rests against the native annulus. Thereafter, the sutures can be tied off and severed to secure the prosthetic valve to the annulus.
  • One specific technique that is used to introduce the prosthetic valve into the aorta is referred to as the “shoehorn” technique. In the shoehorn technique, a transverse incision is made in the aortic root, which typically is smaller than the cross-sectional profile of the prosthetic valve. In order to pass the valve through the incision, the valve is inserted into the aortic root at an angle relative to a plane defined by the incision, much like passing a button through a button hole. As can be appreciated, this technique adds complexity to the procedure, can cause laceration of the tissue, and can cause damage to the prosthetic valve.
  • Another technique used to implant a prosthetic valve involves making an oblique or “hockey stick” shaped incision in the aorta. This type of incision creates a larger opening for the passage of the valve, but is more difficult to close and therefore is more prone to leakage than a straight transverse incision.
  • Accordingly, there exists a need for new and improved apparatus and methods for introducing a prosthetic valve into the vasculature of a patient.
  • SUMMARY
  • The present disclosure concerns embodiments of an introducer that is adapted to facilitate insertion of a prosthetic device, such as a prosthetic heart valve, into a patient's vasculature. In particular embodiments, the introducer comprises an elongated body defining a central lumen extending between distal and proximal ends of the body. The body is adapted to be inserted through an incision, such as a transverse aortotomy, and into the vasculature of the patient. A prosthetic valve can be introduced into the patient's vasculature by advancing the valve through the introducer.
  • The introducer body can have a longitudinally extending gap extending along the length of the body between the distal and proximal ends, which allows the introducer to radially expand and dilate the incision as the valve is advanced through the incision. The gap in the introducer also allows a user to place the introducer around implant sutures by passing the sutures through the gap and into the central lumen. Similarly, the gap allows the introducer to be easily removed from the sutures and/or a delivery device by passing them outwardly through the gap. The introducer body can have a tapered distal portion to facilitate insertion of the introducer through an incision.
  • In one representative embodiment, a method of implanting a prosthetic heart valve comprises making an incision in the vasculature of a patient's body, threading one or more sutures through a native annulus of the heart and extending the one or more sutures outwardly through the incision and through a portion of the prosthetic valve, placing an introducer around the one or more sutures and inserting the introducer into and through the incision such that a distal end and a proximal end of the introducer are on opposite sides of the incision, sliding the prosthetic valve along the one or more sutures and through the introducer until the prosthetic valve engages the annulus, removing the introducer from the incision, and securing the valve to the annulus with the one or more sutures.
  • In another representative embodiment, a method of implanting a prosthetic heart valve comprises making an incision in the vasculature of a patient's body, inserting the introducer through the incision and into the vasculature of the patient, and providing a prosthetic valve mounted on a delivery device comprising an elongated handle. The method further comprises advancing the prosthetic valve and a portion of the handle through the introducer until the prosthetic valve engages a native annulus of the heart, and removing the introducer from the incision and away from a position surrounding the handle by passing the handle through a gap formed in a side of the introducer.
  • In another representative embodiment, an introducer for introducing a prosthetic device into the vasculature of a patient comprises an elongated body having distal and proximal ends and a central passageway extending through the body from the distal end to the proximal end. The body comprises two opposing longitudinal edges defining a gap therebetween, the gap extending from the proximal end to the distal end.
  • The foregoing and other features and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of an introducer, according to one embodiment, that can be used to introduce a prosthetic heart valve into the vasculature of a patient.
  • FIG. 2 is a bottom plan view of the introducer shown in FIG. 1.
  • FIG. 3 is a perspective view of another embodiment of an introducer.
  • FIGS. 4-10 illustrate one specific procedure for implanting a prosthetic aortic valve into the heart using the introducer shown in FIG. 1.
  • FIG. 11 illustrates another procedure for implanting a prosthetic aortic valve into the heart using the introducer shown in FIG. 1.
  • FIG. 12 shows an introducer assembly, according to another embodiment, that can be used to introduce a prosthetic heart valve into the vasculature of a patient.
  • FIGS. 13-17 illustrate one specific procedure for implanting a prosthetic aortic valve into the heart using the introducer assembly shown in FIG. 12.
  • FIG. 18 is a perspective view of another embodiment of an introducer that can be used to introduce a prosthetic heart valve into the vasculature of a patient.
  • DETAILED DESCRIPTION
  • The present disclosure concerns embodiments of an introducer that is adapted to facilitate insertion of a prosthetic device, such as a prosthetic heart valve, into a patient's vasculature. The examples described below involve the implantation of a prosthetic valve in the aortic annulus of the heart. However, the introducer can also be used to facilitate implantation of prosthetic valves into the other native annuluses of the heart. Further, the introducer can also be used to introduce various other prosthetic devices into other body lumens.
  • Referring first to FIGS. 1 and 2, an introducer 10, according to one embodiment, comprises an elongated body 12 having a proximal end 14 and a distal end 16. The body 12 has a length L extending from the proximal end 14 to the distal end 16. The body 12 has a proximal opening 18, a distal opening 20, a central lumen, or passageway, 22 extending longitudinally through the body from the proximal opening to the distal opening. The body 12 desirably has a proximal flange 24 that extends circumferentially around the proximal opening and radially outwardly therefrom. The proximal flange 24 can have an enlarged portion 26 that functions as a handle for grasping and manipulating the introducer during use.
  • The body 12 in the illustrated embodiment has a generally cylindrical shape along the majority of its length and a tapered distal end portion 28 that extends about one third the length of the body. Thus, as can be seen in FIGS. 1 and 2, the proximal opening 18 has a larger diameter than that of the distal opening 20. The tapered distal end portion 28 facilitates insertion of the introducer into a surgical incision, as described below. The body 12 desirably has a plurality of angularly spaced, longitudinally extending gaps 30 defining a plurality of longitudinally extending, circumferentially arrayed fingers 32. The fingers 32 can flex radially outwardly from each other from a non-expanded, or contracted, state (FIG. 1) to an expanded state (FIG. 8) to expand the distal opening to accommodate a prosthetic valve as it is pushed through the distal end portion of the introducer. The proximal end of each gap 30 can terminate at an enlarged circular aperture 34 that facilitates bending or flexing of the fingers at their proximal ends where each finger joins the remaining portion of the body 12.
  • The body 12 desirably has a longitudinal gap 36 extending the entire length of the body from the proximal end 14 to the distal end 16 and defining longitudinal edges 38. In the illustrated embodiment, the gap 36 has a constant width from the distal end 16 to a location near the proximal end and then flares or widens from this location toward the proximal end 14 to form an enlarged mouth 40 of the gap at the proximal end. The gap 36 allows the introducer 10 to be easily placed around and removed from sutures and/or a delivery device, as further described below. The gap 36 also allows the introducer body 12 to radially expand to accommodate a prosthetic valve having a larger diameter than that of the introducer as the valve is advanced through the introducer. In the illustrated embodiment, the gap 36 can be referred to as a permanent gap because there is a gap or opening between the longitudinal edges 36 when the introducer is in its nonexpanded, or contracted, state shown in FIG. 1.
  • In an alternative embodiment, the entire length of the gap 36 or a portion thereof can be replaced with a longitudinally extending slit between the longitudinal edges 38. When the body is in a non-expanded state, the edges 38 can contact each other to close the slit. Because the introducer body is made of a flexible material, the edges 38 can be separated to create an opening or gap therebetween, such as for placing the introducer around sutures or a delivery device, as described below. Similarly, the distal end portion 28 can be formed with a plurality of slits defining the fingers 32, rather than permanent gaps 30 between adjacent fingers as shown in the illustrated embodiment.
  • The introducer 10 can be formed from any of various suitable materials, including metals (e.g., stainless steel or Nitinol), alloys, polymers (e.g., nylon or PTFE), composites, or combinations thereof. In certain embodiments, the introducer can be sized for use with a variety of valve sizes (e.g., 17-35 mm valves). Alternatively, the introducer can be provided in a range of different sizes with each size adapted for use with one valve size or a range of valve sizes.
  • FIG. 3 shows an introducer 50, according to another embodiment. The introducer 50 is similar to the introducer 10 shown in FIGS. 1 and 2 in most respects. Unlike the introducer 10, the introducer 50 has a flange portion 52 formed with an opening 54. The opening 54 can be adapted to receive the distal end of an elongated handle 56 that can be used to assist in positioning and manipulating the introducer during use.
  • FIGS. 4-11 illustrate the use of the introducer 10 in one specific procedure for implanting a prosthetic heart valve 60 in the aortic annulus. The prosthetic valve 60 in the illustrated embodiment includes a substantially rigid, non-collapsible annular frame 62, a plurality of leaflets 64 supported by the frame, a sewing ring 66, and a plastically expandable stent, or support frame, 68 extending downwardly from the sewing ring. The prosthetic valve 60 can be referred to as a hybrid valve in that it combines a non-collapsible surgical valve and an expandable stent that is typically incorporated in expandable prosthetic valves that are delivered in minimally invasive procedures. The prosthetic valve 60 can be mounted to the distal end of an elongated shaft or handle of a delivery device 72. Exemplary embodiments of the prosthetic valve 60 and the delivery device 72 are further described in co-pending U.S. Application No. 61/165, 455 filed Mar. 31, 2009 and U.S. Application No. 61/220,968, filed Jun. 26, 2009, which are incorporated herein by reference.
  • As shown in FIG. 4, an incision can be made in the aorta to access the aortic annulus. Typically, although not required, the native leaflets are excised before implanting the prosthetic valve, as shown in the figures. A plurality of implant sutures 70 can be threaded through the periphery of the aortic annulus, extended outside of the body through the incision and then threaded through the sewing ring 66 of the prosthetic valve 60 in a conventional manner. It has been found that three implant sutures are sufficient to adequately secure the prosthetic valve in place at the implantation site when the securement of the valve to the annulus is supplemented by the stent 68. A greater or fewer number of implant sutures can be used in other applications.
  • To assist in passing the prosthetic valve 60 through the incision in the aorta using the introducer, the introducer 10 is first placed around the sutures 70 and inserted through the incision. Because the introducer has a gap 36 extending the length of the introducer, it can be easily placed around the sutures at a location between the incision and the valve by passing the sutures through the gap 36, as depicted in FIGS. 4 and 5. The enlarged mouth portion 40 of the gap facilitates this process in that it allows the operator to more easily direct the implant sutures 70 into and through the gap 36.
  • As shown in FIG. 6, the introducer 10 can then be inserted through the incision into the aorta. The tapered distal end portion 28 facilitates the insertion of the introducer through the incision. The introducer desirably is positioned such that the distal end 16 is positioned in the native annulus or in the Valsalva sinuses immediately adjacent the native annulus. In this manner, the prosthetic valve can be guided directly to the desired implantation position as it is advanced from the distal end of the introducer. After the introducer is inserted into the aorta, the surgeon can push the prosthetic valve through the introducer and into the aorta. If the outer diameter of the prosthetic valve 60 is greater than the diameter of the introducer, the introducer can radially expand as the prosthetic valve passes through the introducer due to the presence of the gap 36, as depicted in FIGS. 6-8. In addition the fingers 32 can expand radially outwardly from each other to accommodate the passage of the valve through the tapered distal end portion 28 of the introducer.
  • In the illustrated example, the incision can be made smaller than the cross-sectional profile of the prosthetic valve taken at sewing ring 66 (the cross-sectional profile is taken at a plane that extends through the sewing ring and is perpendicular to the central axis of the valve). Thus, as the valve passes through the incision in this example, the incision is caused to dilate by the radial force of the valve against the introducer, allowing the valve to slide through the introducer at the location of the incision while minimizing or preventing laceration of the tissue. Moreover, the prosthetic valve can be pushed through the incision while the valve is maintained at a position in which the cross-sectional profile of the valve is generally perpendicular to the line of movement through the introducer and the incision; in other words, the valve need not be tilted or canted in order to pass the valve through the incision, as required to perform a conventional “shoehorn” technique.
  • As shown in FIG. 9, the valve can be advanced out of the distal end of the introducer 10 and seated against the aortic annulus. At this time, the introducer 10 can be removed from the incision and from its position extending around the sutures 70 and the delivery device 72. The introducer can be removed from its position extending around the sutures 70 and the delivery device 72 by simply withdrawing the introducer laterally away from the sutures and the delivery device while directing them to pass through the gap 36 in the introducer. Due to the presence of the gap, the introducer can be removed sideways with respect to the delivery device and does not need to be withdrawn off of the proximal end of the delivery device, which is being held in one hand of the surgeon. Advantageously, this allows the surgeon to easily and quickly remove the introducer without having to remove the hand from the proximal end of the delivery device.
  • As further shown in FIG. 9, after removing the introducer 10, the expandable stent 68 can be deployed by advancing a balloon catheter 74 of the delivery device proximally relative to the valve to displace a nose cone 76 out of engagement with the stent 68 and to position a balloon 78 of the balloon catheter to extend through the stent 68. The balloon 78 can then be inflated to cause the stent 68 to radially expand and engage surrounding tissue. Thereafter, the balloon is deflated, the sutures 70 are tied off to secure the sewing ring 66 to the aortic annulus, and the delivery device is detached from the valve 60 and removed from the body. As can be appreciated, in the illustrated example, the prosthetic valve is secured in place against the native annulus by a combination of the sutures 70 and the radial outward force of the expandable stent 68.
  • It can be appreciated that the introducer can be used to assist in the implantation of other types of prosthetic valves. For example, the introducer can be used to introduce a conventional surgical valve (i.e., one that does not have an expandable stent, like stent 68 of valve 60) into the patient's vasculature. When implanting a conventional surgical valve, a greater number of implant sutures 70, typically about 15-21 sutures, are used to secure the valve to the native annulus. The introducer can also be used to introduce into a patient's vasculature a transcatheter heart valve that can be radially compressed to a reduced diameter for insertion into the patient's vasculature and radially expandable to its functional size at the deployment site inside the body.
  • In addition, the introducer 10 can be used introduce a valve into the patient's vasculature via any type of aortotomy (incision in the aorta). For example, FIG. 11 illustrates the implantation of a prosthetic valve 60 via a transverse aortotomy where a transverse incision is made through the aortic root. A plurality of implant sutures can be threaded through the native annulus and the sewing ring 66 of the valve, as described above. As shown, the introducer 10 can be placed around the sutures by passing the sutures through the gap 36, and then inserting the distal end portion 28 of the introducer into the aortic root until the distal end is just above the native annulus. The prosthetic valve 60 can then be pushed through the introducer, into the aorta and into the native annulus. The valve can be secured in place by deploying the stent 68 and tying off the implant sutures 70, as described above. If the prosthetic valve has a diameter greater than that of the portion of the aorta through which the valve passes, the introducer 10 causes the aorta to dilate around the valve as it is passed through the introducer toward the annulus, thereby allowing for atraumatic passage of the valve and protecting against damage to the valve itself. Moreover, the valve can be introduced while held perpendicular to the line of movement into and through the aorta; that is, the valve need not be tilted or canted relative to the line of movement in order pass the relatively larger valve into the aorta.
  • FIG. 12 illustrates an introducer assembly 100, according to another embodiment, that can be used to introduce a prosthetic device, such as a prosthetic valve 60, into the vasculature of a patient. The assembly 100 in the illustrated embodiment comprises an introducer 101 (also referred to as a sleeve) and an applicator frame, or mounting frame, 102 configured to mount the introducer 101 around the prosthetic valve. The introducer 101 can comprise a tubular sleeve made of a stretchable, flexible and/or resilient material, such as a fabric. The applicator 102 is configured to retain the introducer 101 in an expanded state having a generally cylindrical configuration to allow the prosthetic valve to be placed within the introducer during use. The applicator 102 can comprise proximal and distal rings 104, 106, respectively, interconnected by a plurality of longitudinal members 108 extending between and interconnecting the rings. The applicator 102 desirably is made of a relatively rigid material as compared to the introducer, such as metal or plastic.
  • FIGS. 13-17 illustrate the implantation of the valve into the aortic annulus via a transverse aortotomy made at the aortic root. However, it should be understood that various other aortotmies can be performed to gain access to the native annulus for implanting the prosthetic valve using the introducer assembly 100. In any case, as shown in FIG. 13, implant sutures 70 can be threaded through the native annulus and the sewing ring 66 of the valve. The introducer 101 is first placed around the applicator 102, and the assembly 100 is placed around the sutures 70, as depicted in FIG. 13, by inserting the proximal ends of the sutures 70 and the delivery device (the proximal ends are not shown in FIG. 13) into the distal opening of the applicator 102 and sliding the assembly downwardly to the position shown in FIG. 13. The inner diameter of the applicator 102 (defined by proximal and distal rings 104, 106) is dimensioned large enough to permit the valve to pass easily through the applicator.
  • Referring to FIG. 14, the valve 60 can then be positioned within the expanded introducer 101. With the valve inside of the introducer 101, the introducer is removed from the applicator, such as by holding the introducer and the valve stationary and retracting the applicator 102 upwardly in the direction of arrow 110. The applicator 102 can be removed from its position surrounding the sutures and the delivery device 72 by withdrawing the applicator upwardly beyond the proximal ends of the sutures and the delivery device. When the applicator is removed, the introducer 101 collapses around and desirably extends over and covers the entire valve such that a distal end portion 112 of the introducer extends beyond the lower end of the valve, as depicted in FIG. 15.
  • Referring to FIG. 16, the distal end portion of the introducer 101 is then inserted into the aortic root. The valve 60 can then be inserted into the aortic root by maintaining slight upward tension on the introducer 101 (in the direction of arrow 114) while pushing downwardly on the valve 60 via the delivery device (in the direction of arrow 116). As the valve is pushed through the introducer and into the aortic root, the vessel dilates and allows the valve to be advanced through the vessel to the implantation site at the aortic annulus. When the valve is at the desired position, the valve is held firmly in place via the delivery device and the introducer 101 is pulled out of the aortic root and then removed from the delivery device (FIG. 17) by moving the introducer upwardly beyond the proximal ends of the suture and the delivery device and the sutures. Thereafter, the valve can be secured in place by deploying the stent 68 and tying off the implant sutures 70, as described above.
  • FIG. 18 shows an introducer 150, according to another embodiment, that can be used to introduce a prosthetic device, such as a prosthetic valve 60, into the vasculature of a patient. The introducer 150 comprises a thin-walled, generally tubular body 152 defining a central lumen, or passageway, 154. The introducer body 152 is constructed from a thin membrane made of a flexible material, such as a flexible polymer, that forms a tubular outer membrane 156 and a tubular inner membrane 158. The outer and inner membranes are joined to each other at the opposite ends of the body so as to form a sealed inner cavity that can contain a fluid, such as a sterile liquid. The introducer body exhibits sufficient flexibility to allow the positions of the inner and outer members to be reversed; that is, the outer membrane 156 can be turned and pushed inwardly into the lumen 154 at one end of the body to become part of the inner membrane (as indicated by arrows 160) while the inner membrane 158 at the opposite end of the body is caused to turn and move outwardly (as indicated by arrows 162) so as to become part of the outer membrane.
  • In use, a prosthetic valve 60 (or other prosthetic device), which can be mounted to the distal end of a delivery device as described herein, can be inserted into the lumen 154 of the introducer 150. This can be accomplished by pushing or urging the valve into the opening at one end of the introducer. The rolling or reversing action of the membranes causes the introducer to “roll” onto and over the valve. With the introducer 150 covering the valve, one end of the introducer is inserted into an incision made in the aorta (or another part of the patient's vasculature). The valve can then be pushed through the introducer and into the aorta. As the valve is advanced through the introducer, the membranes 156, 158 can roll relative to the valve to facilitate its passage through the lumen 154.
  • In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

Claims (21)

1. A method of implanting a prosthetic heart valve comprising:
making an incision in the vasculature of a patient's body;
threading one or more sutures through a native annulus of the heart and extending the one or more sutures outwardly through the incision and through a portion of the prosthetic valve;
placing an introducer around the one or more sutures and inserting the introducer into and through the incision such that a distal end and a proximal end of the introducer are on opposite sides of the incision;
sliding the prosthetic valve along the one or more sutures and through the introducer until the prosthetic valve engages the annulus;
removing the introducer from the incision; and
securing the valve to the annulus with the one or more sutures.
2. The method of claim 1, wherein:
the introducer comprises an elongated body, a central passageway extending through the body, and a longitudinally extending gap in the introducer body extending from the proximal end to the distal end; and
the act of placing the introducer around the one or more sutures comprises passing the one or more sutures through the gap in the introducer body and into the central opening of the introducer.
3. The method of claim 2, further comprising, after removing the introducer from the incision, removing the introducer from a position surrounding the one or more sutures by passing the one or more sutures outwardly through the gap in the introducer body.
4. The method of claim 1, wherein the incision is made in the aorta and the one or more sutures are secured to aortic annulus of the heart.
5. The method of claim 1, wherein the act of inserting the introducer into and through the incision comprises positioning the distal end of the introducer in or immediately adjacent the native annulus.
6. The method of claim 1, wherein:
the introducer comprises an elongated body, a central passageway extending through the body, and a longitudinally extending gap in the introducer body extending from the proximal end to the distal end; and
sliding the prosthetic valve through the introducer causes the introducer body to radially expand.
7. The method of claim 3, wherein the act of sliding the prosthetic valve along the one or more sutures and through the introducer comprises pushing the prosthetic valve through the introducer with an elongated delivery apparatus having a distal end mounting the prosthetic valve, and the act of removing the introducer from a position surrounding the one or more sutures further comprises removing the introducer from a position surrounding the delivery apparatus by passing the delivery apparatus outwardly through the gap in the introducer body.
8. The method of claim 2, wherein the gap widens from a first width at a location spaced from the proximal end to a second, greater width at the proximal end.
9. The method of claim 1, further comprising radially expanding a stent of the prosthetic valve against the annulus to further anchor the valve to the annulus.
10. The method of claim 9, wherein the act of radially expanding a stent of the prosthetic valve comprises inflating a balloon to cause expansion of the stent.
11. The method of claim 1, wherein the introducer comprises a radially stretchable sleeve and prior to the act of inserting the introducer into the vasculature, the method further comprises placing the sleeve over an applicator frame to hold the sleeve in a radially expanded state, positioning the prosthetic valve in the applicator frame, and removing the applicator frame from the sleeve to allow the sleeve to collapse around the prosthetic valve.
12. The method of claim 11, wherein the sleeve comprises a fabric.
13. The method of claim 1, wherein the introducer comprises a generally tubular body comprising a flexible outer membrane, a flexible inner membrane, and a liquid contained between the inner and outer membranes.
14. A method of implanting a prosthetic heart valve comprising:
making an incision in the vasculature of a patient's body;
inserting the introducer through the incision and into the vasculature of the patient;
providing a prosthetic valve mounted on a delivery device comprising an elongated handle;
advancing the prosthetic valve and a portion of the handle through the introducer until the prosthetic valve engages a native annulus of the heart; and
removing the introducer from the incision and away from a position surrounding the handle by passing the handle through a gap formed in a side of the introducer.
15. The method of claim 14, wherein prior to the act of sliding the prosthetic valve and a portion of the handle through the introducer, the method further comprises threading one or more sutures through the native annulus and a sewing ring of the prosthetic valve and placing the introducer around the one or more sutures by passing the one or more sutures through the gap and into a central lumen of the introducer.
16. The method of claim 14, wherein the introducer comprises a tapered distal end portion, the distal end portion comprising a plurality of circumferentially arrayed, radially expandable fingers having distal ends defining a distal opening of the introducer, the fingers being radially expandable from a non-expanded state to an expanded state as the prosthetic valve is advanced through the distal end portion.
17. An introducer for introducing a prosthetic device into the vasculature of a patient comprising:
an elongated body having distal and proximal ends; and
a central passageway extending through the body from the distal end to the proximal end;
the body comprising two opposing longitudinal edges defining a gap therebetween.
18. The introducer of claim 17, wherein the gap has a first width at a location spaced from the proximal end and increases to a second width, greater than the first width, at the proximal end.
19. The introducer of claim 17, wherein the body comprises a tapered distal end portion, the distal end portion comprising a plurality of circumferentially arrayed, radially expandable fingers having distal ends defining a distal opening of the body, the fingers being radially expandable from a non-expanded state to an expanded state so as to expand the distal opening.
20. The introducer of claim 19, wherein the distal end portion comprises longitudinally extending gaps between the fingers.
21. The introducer of claim 17, wherein the gap extends from the proximal end to the distal end.
US12/839,194 2009-07-23 2010-07-19 Introducer for prosthetic heart valve Abandoned US20110022165A1 (en)

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CN2010800415781A CN102548486A (en) 2009-07-23 2010-07-21 Introducer for prosthetic heart valve
PCT/US2010/042697 WO2011011481A2 (en) 2009-07-23 2010-07-21 Introducer for prosthetic heart valve
EP10802825.9A EP2456363B1 (en) 2009-07-23 2010-07-21 Introducer for prosthetic device
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Cited By (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090306768A1 (en) * 2006-07-28 2009-12-10 Cardiaq Valve Technologies, Inc. Percutaneous valve prosthesis and system and method for implanting same
US20100082089A1 (en) * 2008-10-01 2010-04-01 Arshad Quadri Delivery system for vascular implant
US20110060404A1 (en) * 2009-08-28 2011-03-10 Malewicz Andrzej M Surgical delivery device and method of use
US20110224785A1 (en) * 2010-03-10 2011-09-15 Hacohen Gil Prosthetic mitral valve with tissue anchors
US8414644B2 (en) 2009-04-15 2013-04-09 Cardiaq Valve Technologies, Inc. Vascular implant and delivery system
US20130090725A1 (en) * 2009-06-26 2013-04-11 Edwards Lifesciences Corporation Unitary quick-connect prosthetic heart valve deployment methods
US8652203B2 (en) 2010-09-23 2014-02-18 Cardiaq Valve Technologies, Inc. Replacement heart valves, delivery devices and methods
WO2014072925A1 (en) * 2012-11-09 2014-05-15 Dp Shaw Limited Insertion tool for a heart valve
DE102013205519A1 (en) * 2013-03-27 2014-10-02 Fehling Instruments Gmbh & Co. Kg Spreader for the atrium of the heart
US8852272B2 (en) 2011-08-05 2014-10-07 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US8870950B2 (en) 2009-12-08 2014-10-28 Mitral Tech Ltd. Rotation-based anchoring of an implant
US8894702B2 (en) 2008-09-29 2014-11-25 Cardiaq Valve Technologies, Inc. Replacement heart valve and method
EP2842517A1 (en) * 2011-12-29 2015-03-04 Sorin Group Italia S.r.l. A kit for implanting prosthetic vascular conduits
US8992604B2 (en) 2010-07-21 2015-03-31 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US9017399B2 (en) 2010-07-21 2015-04-28 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US20150190229A1 (en) * 2011-06-20 2015-07-09 Jacques Seguin Prosthetic leaflet assembly for repairing a defective cardiac valve and methods of using the same
US9125741B2 (en) 2010-09-10 2015-09-08 Edwards Lifesciences Corporation Systems and methods for ensuring safe and rapid deployment of prosthetic heart valves
EP3000433A1 (en) * 2014-09-29 2016-03-30 Sofradim Production Device for introducing a prosthesis for hernia treatment into an incision
US9314334B2 (en) 2008-11-25 2016-04-19 Edwards Lifesciences Corporation Conformal expansion of prosthetic devices to anatomical shapes
USD755384S1 (en) 2014-03-05 2016-05-03 Edwards Lifesciences Cardiaq Llc Stent
US20160270816A1 (en) * 2015-03-20 2016-09-22 Spinecraft, LLC MIS Access Port and Methods of Using
US9468527B2 (en) 2013-06-12 2016-10-18 Edwards Lifesciences Corporation Cardiac implant with integrated suture fasteners
US9480560B2 (en) 2009-09-29 2016-11-01 Edwards Lifesciences Cardiaq Llc Method of securing an intralumenal frame assembly
US9486336B2 (en) 2005-11-10 2016-11-08 Edwards Lifesciences Cardiaq Llc Prosthesis having a plurality of distal and proximal prongs
US9504563B2 (en) 2010-09-10 2016-11-29 Edwards Lifesciences Corporation Rapidly deployable surgical heart valves
US9554903B2 (en) 2005-05-24 2017-01-31 Edwards Lifesciences Corporation Rapid deployment prosthetic heart valve
US9554897B2 (en) 2011-04-28 2017-01-31 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US9572665B2 (en) 2013-04-04 2017-02-21 Neovasc Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
US9585752B2 (en) 2014-04-30 2017-03-07 Edwards Lifesciences Corporation Holder and deployment system for surgical heart valves
US9629720B2 (en) 2015-05-04 2017-04-25 Jacques Seguin Apparatus and methods for treating cardiac valve regurgitation
US9681951B2 (en) 2013-03-14 2017-06-20 Edwards Lifesciences Cardiaq Llc Prosthesis with outer skirt and anchors
US9681952B2 (en) 2013-01-24 2017-06-20 Mitraltech Ltd. Anchoring of prosthetic valve supports
US9713529B2 (en) 2011-04-28 2017-07-25 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US9724083B2 (en) 2013-07-26 2017-08-08 Edwards Lifesciences Cardiaq Llc Systems and methods for sealing openings in an anatomical wall
US9730791B2 (en) 2013-03-14 2017-08-15 Edwards Lifesciences Cardiaq Llc Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
US9763657B2 (en) 2010-07-21 2017-09-19 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US9770329B2 (en) 2010-05-05 2017-09-26 Neovasc Tiara Inc. Transcatheter mitral valve prosthesis
USD800908S1 (en) 2016-08-10 2017-10-24 Mitraltech Ltd. Prosthetic valve element
US9919137B2 (en) 2013-08-28 2018-03-20 Edwards Lifesciences Corporation Integrated balloon catheter inflation system
US9974651B2 (en) 2015-02-05 2018-05-22 Mitral Tech Ltd. Prosthetic valve with axially-sliding frames
US10016275B2 (en) 2012-05-30 2018-07-10 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
USD841812S1 (en) 2017-08-03 2019-02-26 Cardiovalve Ltd. Prosthetic heart valve element
US10245143B2 (en) 2011-08-05 2019-04-02 Cardiovalve Ltd. Techniques for percutaneous mitral valve replacement and sealing
USD846122S1 (en) 2016-12-16 2019-04-16 Edwards Lifesciences Corporation Heart valve sizer

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2547990C2 (en) 2009-09-28 2015-04-10 Интарсия Терапьютикс, Инк. Fast achievement and/or completion of substantial stable drug delivery
US20120208755A1 (en) 2011-02-16 2012-08-16 Intarcia Therapeutics, Inc. Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers
US10076414B2 (en) 2012-02-13 2018-09-18 Mitraspan, Inc. Method and apparatus for repairing a mitral valve
WO2015109243A1 (en) * 2012-02-13 2015-07-23 Mitraspan, Inc. Method and apparatus for repairing a mitral valve
CN103610520B (en) * 2013-12-05 2016-08-17 杭州启明医疗器械有限公司 A prosthetic heart valve grip device
USD840030S1 (en) * 2016-06-02 2019-02-05 Intarcia Therapeutics, Inc. Implant placement guide

Citations (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3049013A (en) * 1958-10-20 1962-08-14 Socony Mobil Oil Co Inc Pressure control system
US3409013A (en) * 1965-08-23 1968-11-05 Berry Henry Instrument for inserting artificial heart valves
US3587115A (en) * 1966-05-04 1971-06-28 Donald P Shiley Prosthetic sutureless heart valves and implant tools therefor
US3671979A (en) * 1969-09-23 1972-06-27 Univ Utah Catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve
US4056854A (en) * 1976-09-28 1977-11-08 The United States Of America As Represented By The Department Of Health, Education And Welfare Aortic heart valve catheter
US4058854A (en) * 1975-07-24 1977-11-22 Jhoon Goo Rhee Protective helmet
US4243050A (en) * 1977-12-13 1981-01-06 Littleford Philip O Method for inserting pacemaker electrodes and the like
US4306562A (en) * 1978-12-01 1981-12-22 Cook, Inc. Tear apart cannula
US4581025A (en) * 1983-11-14 1986-04-08 Cook Incorporated Sheath
US4631052A (en) * 1984-01-03 1986-12-23 Intravascular Surgical Instruments, Inc. Method and apparatus for surgically removing remote deposits
US4798554A (en) * 1986-03-11 1989-01-17 Nelson David C Balloon holder
US4813401A (en) * 1986-11-26 1989-03-21 Grieshaber Manufacturing Company Retractor
US4883458A (en) * 1987-02-24 1989-11-28 Surgical Systems & Instruments, Inc. Atherectomy system and method of using the same
US4921479A (en) * 1987-10-02 1990-05-01 Joseph Grayzel Catheter sheath with longitudinal seam
US5032128A (en) * 1988-07-07 1991-07-16 Medtronic, Inc. Heart valve prosthesis
US5089015A (en) * 1989-11-28 1992-02-18 Promedica International Method for implanting unstented xenografts and allografts
US5370685A (en) * 1991-07-16 1994-12-06 Stanford Surgical Technologies, Inc. Endovascular aortic valve replacement
US5797920A (en) * 1996-06-14 1998-08-25 Beth Israel Deaconess Medical Center Catheter apparatus and method using a shape-memory alloy cuff for creating a bypass graft in-vivo
US6010531A (en) * 1993-02-22 2000-01-04 Heartport, Inc. Less-invasive devices and methods for cardiac valve surgery
US6224586B1 (en) * 1999-09-04 2001-05-01 Endosonics Corporation Positioning device
US6449865B1 (en) * 1999-08-23 2002-09-17 Thad Heckman Dipstick guide
US6589212B1 (en) * 1999-11-08 2003-07-08 Janin Group, Inc. Guide for surgical device
US20040073286A1 (en) * 2001-01-22 2004-04-15 Armstrong Joseph P. Deployment system for intraluminal devices
US20050154441A1 (en) * 2004-01-14 2005-07-14 Cook Incorporated Introducer
US20060106415A1 (en) * 2004-11-12 2006-05-18 Shlomo Gabbay Apparatus to facilitate implantation
US7144386B2 (en) * 2001-06-29 2006-12-05 Ab Korkor Medical, Inc. Catheter introducer having an expandable tip
US20070219629A1 (en) * 2005-01-27 2007-09-20 Valve Special Purpose Co., Llc Heart Valve Inserter
US20070225659A1 (en) * 2006-03-21 2007-09-27 Cook Incorporated Introducer sheath having frangible tip
US20070225801A1 (en) * 2006-03-10 2007-09-27 Drews Michael J Valve introducers and methods for making and using them
US20070239254A1 (en) * 2006-04-07 2007-10-11 Chris Chia System for percutaneous delivery and removal of a prosthetic valve
US20080021552A1 (en) * 2001-10-09 2008-01-24 Shlomo Gabbay Apparatus To Facilitate Implantation
US20080255580A1 (en) * 2007-03-31 2008-10-16 Hoffman Grant T Medical device delivery system with sheath separation
US7662160B2 (en) * 2004-01-28 2010-02-16 Smith & Nephew, Inc. Suture loading

Family Cites Families (53)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3164009A (en) 1960-10-07 1965-01-05 Pure Oil Co Apparatus for measuring the wall thickness of tubing
US4185638A (en) 1975-06-30 1980-01-29 Sandoz, Inc. Pressure indicators for inflatable cuff-type catheters
US4016867A (en) 1976-04-27 1977-04-12 The United States Of America As Represented By The Secretary Of The Department Of Health, Education And Welfare Uterine caliper and depth gauge
GB2083362B (en) 1977-12-29 1982-11-24 Yeshiva University Albert Eins Disposable heart valve unit
US4211241A (en) 1978-03-03 1980-07-08 Kastec Corporation Heart valve sizing gauge
US4643194A (en) 1980-01-24 1987-02-17 Thomas J. Fogarty Flexible calibrator
US4362167A (en) 1981-02-06 1982-12-07 Nicolai Donald R Diagnostic measuring instrument
FR2543834B1 (en) 1983-04-07 1985-08-23 Descartes Universite Rene Probe variable geometry for measurement of radial stresses in a sphincter of a living organism
US5042161A (en) 1985-10-07 1991-08-27 Joseph Hodge Intravascular sizing method and apparatus
US5010892A (en) 1988-05-04 1991-04-30 Triangle Research And Development Corp. Body lumen measuring instrument
US4940459A (en) 1988-10-12 1990-07-10 Mallinckrodt, Inc. Inflation device for balloon catheter
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
US5531785A (en) 1994-05-06 1996-07-02 Autogenics, Inc. Prosthetic heart valve holder
US5752522A (en) 1995-05-04 1998-05-19 Cardiovascular Concepts, Inc. Lesion diameter measurement catheter and method
US5716417A (en) 1995-06-07 1998-02-10 St. Jude Medical, Inc. Integral supporting structure for bioprosthetic heart valve
WO1996040006A1 (en) 1995-06-07 1996-12-19 St. Jude Medical, Inc. Adjustable sizing apparatus for heart annulus
DE69700302T2 (en) 1996-01-05 2000-03-23 Baxter Int Obturator for calibrating artificial aortic valve
US5885228A (en) 1996-05-08 1999-03-23 Heartport, Inc. Valve sizer and method of use
WO1997042871A1 (en) 1996-05-10 1997-11-20 Cardiovascular Concepts, Inc. Lesion diameter measurement catheter and method
US6045576A (en) 1997-09-16 2000-04-04 Baxter International Inc. Sewing ring having increased annular coaptation
US6019739A (en) 1998-06-18 2000-02-01 Baxter International Inc. Minimally invasive valve annulus sizer
US6210338B1 (en) 1998-08-21 2001-04-03 Aga Medical Corp. Sizing catheter for measuring cardiovascular structures
US6050973A (en) 1998-09-14 2000-04-18 Ave Connaught Pressure limiting device
US6319281B1 (en) 1999-03-22 2001-11-20 Kumar R. Patel Artificial venous valve and sizing catheter
US6136017A (en) 1999-04-23 2000-10-24 Sulzer Carbomedics Inc. One handed instrument for spreading a heart valve
AT366557T (en) 1999-04-28 2007-08-15 St Jude Medical Aortenherzklappenprothesenmess- and - marking device
US6309417B1 (en) * 1999-05-12 2001-10-30 Paul A. Spence Heart valve and apparatus for replacement thereof
US6350281B1 (en) 1999-09-14 2002-02-26 Edwards Lifesciences Corp. Methods and apparatus for measuring valve annuluses during heart valve-replacement surgery
US6598307B2 (en) 1999-11-17 2003-07-29 Jack W. Love Device and method for assessing the geometry of a heart valve
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
WO2002022054A1 (en) 2000-09-12 2002-03-21 Gabbay S Valvular prosthesis and method of using same
US7510572B2 (en) 2000-09-12 2009-03-31 Shlomo Gabbay Implantation system for delivery of a heart valve prosthesis
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
US7270142B2 (en) 2005-01-03 2007-09-18 Acosta Carlos R Inflation device with automatic disconnect
US7955385B2 (en) 2005-02-28 2011-06-07 Medtronic Vascular, Inc. Device, system, and method for aiding valve annuloplasty
US7713216B2 (en) 2006-04-10 2010-05-11 Intrapartum, Llc Method for cervical dilation and/or measurement
US8585594B2 (en) 2006-05-24 2013-11-19 Phoenix Biomedical, Inc. Methods of assessing inner surfaces of body lumens or organs
JP2009539422A (en) 2006-06-02 2009-11-19 メドトロニック・インコーポレーテッド Annuloplasty ring and angioplasty
US7534261B2 (en) * 2006-10-02 2009-05-19 Edwards Lifesciences Corporation Sutureless heart valve attachment
US9192471B2 (en) 2007-01-08 2015-11-24 Millipede, Inc. Device for translumenal reshaping of a mitral valve annulus
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
CA2698388C (en) 2007-09-07 2015-11-24 Edwards Lifesciences Corporation Active holder for annuloplasty ring delivery
WO2009067519A2 (en) 2007-11-19 2009-05-28 The Cleveland Clinic Foundation Apparatus and method for treating a regurgitant heart valve
JP5107065B2 (en) 2008-01-15 2012-12-26 オリンパスメディカルシステムズ株式会社 Internal diameter measurement device
US20090192600A1 (en) 2008-01-25 2009-07-30 Ryan Timothy R Sizing device having two sizers and methods of use
US20090192602A1 (en) 2008-01-25 2009-07-30 Medtronic, Inc. Deformable Sizer and Holder Devices for Minimally Invasive Cardiac Surgery
US20100152844A1 (en) 2008-12-15 2010-06-17 Couetil Jean-Paul A Annuloplasty ring with directional flexibilities and rigidities to assist the mitral annulus dynamics
WO2010090720A1 (en) 2009-02-06 2010-08-12 St. Jude Medical, Inc. Robotic heart valve annulus sizer
ES2543460T3 (en) 2009-03-26 2015-08-19 Sorin Group Usa, Inc. Dimensioning annuloplasty devices for minimally invasive interventions
US8449625B2 (en) 2009-10-27 2013-05-28 Edwards Lifesciences Corporation Methods of measuring heart valve annuluses for valve replacement
US20110208293A1 (en) 2010-02-23 2011-08-25 Medtronic, Inc. Catheter-Based Heart Valve Therapy System with Sizing Balloon

Patent Citations (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3049013A (en) * 1958-10-20 1962-08-14 Socony Mobil Oil Co Inc Pressure control system
US3409013A (en) * 1965-08-23 1968-11-05 Berry Henry Instrument for inserting artificial heart valves
US3587115A (en) * 1966-05-04 1971-06-28 Donald P Shiley Prosthetic sutureless heart valves and implant tools therefor
US3671979A (en) * 1969-09-23 1972-06-27 Univ Utah Catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve
US4058854A (en) * 1975-07-24 1977-11-22 Jhoon Goo Rhee Protective helmet
US4056854A (en) * 1976-09-28 1977-11-08 The United States Of America As Represented By The Department Of Health, Education And Welfare Aortic heart valve catheter
US4243050A (en) * 1977-12-13 1981-01-06 Littleford Philip O Method for inserting pacemaker electrodes and the like
US4306562A (en) * 1978-12-01 1981-12-22 Cook, Inc. Tear apart cannula
US4581025A (en) * 1983-11-14 1986-04-08 Cook Incorporated Sheath
US4631052A (en) * 1984-01-03 1986-12-23 Intravascular Surgical Instruments, Inc. Method and apparatus for surgically removing remote deposits
US4798554A (en) * 1986-03-11 1989-01-17 Nelson David C Balloon holder
US4813401A (en) * 1986-11-26 1989-03-21 Grieshaber Manufacturing Company Retractor
US4883458A (en) * 1987-02-24 1989-11-28 Surgical Systems & Instruments, Inc. Atherectomy system and method of using the same
US4921479A (en) * 1987-10-02 1990-05-01 Joseph Grayzel Catheter sheath with longitudinal seam
US5032128A (en) * 1988-07-07 1991-07-16 Medtronic, Inc. Heart valve prosthesis
US5089015A (en) * 1989-11-28 1992-02-18 Promedica International Method for implanting unstented xenografts and allografts
US5370685A (en) * 1991-07-16 1994-12-06 Stanford Surgical Technologies, Inc. Endovascular aortic valve replacement
US5545214A (en) * 1991-07-16 1996-08-13 Heartport, Inc. Endovascular aortic valve replacement
US6010531A (en) * 1993-02-22 2000-01-04 Heartport, Inc. Less-invasive devices and methods for cardiac valve surgery
US5797920A (en) * 1996-06-14 1998-08-25 Beth Israel Deaconess Medical Center Catheter apparatus and method using a shape-memory alloy cuff for creating a bypass graft in-vivo
US6449865B1 (en) * 1999-08-23 2002-09-17 Thad Heckman Dipstick guide
US6224586B1 (en) * 1999-09-04 2001-05-01 Endosonics Corporation Positioning device
US6589212B1 (en) * 1999-11-08 2003-07-08 Janin Group, Inc. Guide for surgical device
US20040073286A1 (en) * 2001-01-22 2004-04-15 Armstrong Joseph P. Deployment system for intraluminal devices
US7144386B2 (en) * 2001-06-29 2006-12-05 Ab Korkor Medical, Inc. Catheter introducer having an expandable tip
US20080021552A1 (en) * 2001-10-09 2008-01-24 Shlomo Gabbay Apparatus To Facilitate Implantation
US20050154441A1 (en) * 2004-01-14 2005-07-14 Cook Incorporated Introducer
US7662160B2 (en) * 2004-01-28 2010-02-16 Smith & Nephew, Inc. Suture loading
US20060106415A1 (en) * 2004-11-12 2006-05-18 Shlomo Gabbay Apparatus to facilitate implantation
US20070219629A1 (en) * 2005-01-27 2007-09-20 Valve Special Purpose Co., Llc Heart Valve Inserter
US20110282438A1 (en) * 2006-03-10 2011-11-17 Medtronic, Inc. Valve Introducers And Methods For Making And Using Them
US20070225801A1 (en) * 2006-03-10 2007-09-27 Drews Michael J Valve introducers and methods for making and using them
US20070225659A1 (en) * 2006-03-21 2007-09-27 Cook Incorporated Introducer sheath having frangible tip
US20070239254A1 (en) * 2006-04-07 2007-10-11 Chris Chia System for percutaneous delivery and removal of a prosthetic valve
US20080255580A1 (en) * 2007-03-31 2008-10-16 Hoffman Grant T Medical device delivery system with sheath separation

Cited By (74)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9554903B2 (en) 2005-05-24 2017-01-31 Edwards Lifesciences Corporation Rapid deployment prosthetic heart valve
US10130468B2 (en) 2005-05-24 2018-11-20 Edwards Lifesciences Corporation Replacement prosthetic heart valves
US9486336B2 (en) 2005-11-10 2016-11-08 Edwards Lifesciences Cardiaq Llc Prosthesis having a plurality of distal and proximal prongs
US20090306768A1 (en) * 2006-07-28 2009-12-10 Cardiaq Valve Technologies, Inc. Percutaneous valve prosthesis and system and method for implanting same
US9339377B2 (en) 2008-09-29 2016-05-17 Edwards Lifesciences Cardiaq Llc Body cavity prosthesis
US8894702B2 (en) 2008-09-29 2014-11-25 Cardiaq Valve Technologies, Inc. Replacement heart valve and method
US9456896B2 (en) 2008-09-29 2016-10-04 Edwards Lifesciences Cardiaq Llc Body cavity prosthesis
US8337541B2 (en) 2008-10-01 2012-12-25 Cardiaq Valve Technologies, Inc. Delivery system for vascular implant
US20100082089A1 (en) * 2008-10-01 2010-04-01 Arshad Quadri Delivery system for vascular implant
US8911455B2 (en) 2008-10-01 2014-12-16 Cardiaq Valve Technologies, Inc. Delivery system for vascular implant
US9597183B2 (en) 2008-10-01 2017-03-21 Edwards Lifesciences Cardiaq Llc Delivery system for vascular implant
US9314334B2 (en) 2008-11-25 2016-04-19 Edwards Lifesciences Corporation Conformal expansion of prosthetic devices to anatomical shapes
US8414644B2 (en) 2009-04-15 2013-04-09 Cardiaq Valve Technologies, Inc. Vascular implant and delivery system
US9339378B2 (en) 2009-04-15 2016-05-17 Edwards Lifesciences Cardiaq Llc Vascular implant and delivery system
US8795356B2 (en) 2009-04-15 2014-08-05 Cardiaq Valve Technologies, Inc. Vascular implant
US9333073B2 (en) 2009-04-15 2016-05-10 Edwards Lifesciences Cardiaq Llc Vascular implant and delivery method
US9339380B2 (en) 2009-04-15 2016-05-17 Edwards Lifesciences Cardiaq Llc Vascular implant
US9333074B2 (en) 2009-04-15 2016-05-10 Edwards Lifesciences Cardiaq Llc Vascular implant and delivery system
US9585747B2 (en) 2009-04-15 2017-03-07 Edwards Lifesciences Cardiaq Llc Vascular implant
US9339379B2 (en) 2009-04-15 2016-05-17 Edwards Lifesciences Cardiaq Llc Vascular implant and delivery system
US8696742B2 (en) * 2009-06-26 2014-04-15 Edwards Lifesciences Corporation Unitary quick-connect prosthetic heart valve deployment methods
US20130090725A1 (en) * 2009-06-26 2013-04-11 Edwards Lifesciences Corporation Unitary quick-connect prosthetic heart valve deployment methods
US20110060404A1 (en) * 2009-08-28 2011-03-10 Malewicz Andrzej M Surgical delivery device and method of use
US9555528B2 (en) 2009-08-28 2017-01-31 Medtronic 3F Therapeutics, Inc. Surgical delivery device and method of use
US9730790B2 (en) 2009-09-29 2017-08-15 Edwards Lifesciences Cardiaq Llc Replacement valve and method
US9023100B2 (en) 2009-09-29 2015-05-05 Cardiaq Valve Technologies, Inc. Replacement heart valves, delivery devices and methods
US9949827B2 (en) 2009-09-29 2018-04-24 Edwards Lifesciences Cardiaq Llc Replacement heart valves, delivery devices and methods
US10166097B2 (en) 2009-09-29 2019-01-01 Edwards Lifesciences Cardiaq Llc Replacement heart valve and method
US9480560B2 (en) 2009-09-29 2016-11-01 Edwards Lifesciences Cardiaq Llc Method of securing an intralumenal frame assembly
US8870950B2 (en) 2009-12-08 2014-10-28 Mitral Tech Ltd. Rotation-based anchoring of an implant
US10231831B2 (en) 2009-12-08 2019-03-19 Cardiovalve Ltd. Folding ring implant for heart valve
US20110224785A1 (en) * 2010-03-10 2011-09-15 Hacohen Gil Prosthetic mitral valve with tissue anchors
US9770329B2 (en) 2010-05-05 2017-09-26 Neovasc Tiara Inc. Transcatheter mitral valve prosthesis
US9763657B2 (en) 2010-07-21 2017-09-19 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US8992604B2 (en) 2010-07-21 2015-03-31 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US9132009B2 (en) 2010-07-21 2015-09-15 Mitraltech Ltd. Guide wires with commissural anchors to advance a prosthetic valve
US9017399B2 (en) 2010-07-21 2015-04-28 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US10039641B2 (en) 2010-09-10 2018-08-07 Edwards Lifesciences Corporation Methods of rapidly deployable surgical heart valves
US9125741B2 (en) 2010-09-10 2015-09-08 Edwards Lifesciences Corporation Systems and methods for ensuring safe and rapid deployment of prosthetic heart valves
US9504563B2 (en) 2010-09-10 2016-11-29 Edwards Lifesciences Corporation Rapidly deployable surgical heart valves
US9968450B2 (en) 2010-09-10 2018-05-15 Edwards Lifesciences Corporation Methods for ensuring safe and rapid deployment of prosthetic heart valves
US8652203B2 (en) 2010-09-23 2014-02-18 Cardiaq Valve Technologies, Inc. Replacement heart valves, delivery devices and methods
US9554897B2 (en) 2011-04-28 2017-01-31 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US9713529B2 (en) 2011-04-28 2017-07-25 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US20150190229A1 (en) * 2011-06-20 2015-07-09 Jacques Seguin Prosthetic leaflet assembly for repairing a defective cardiac valve and methods of using the same
US10245143B2 (en) 2011-08-05 2019-04-02 Cardiovalve Ltd. Techniques for percutaneous mitral valve replacement and sealing
US8852272B2 (en) 2011-08-05 2014-10-07 Mitraltech Ltd. Techniques for percutaneous mitral valve replacement and sealing
US9387078B2 (en) 2011-08-05 2016-07-12 Mitraltech Ltd. Percutaneous mitral valve replacement and sealing
US10226341B2 (en) 2011-08-05 2019-03-12 Cardiovalve Ltd. Implant for heart valve
US9138314B2 (en) 2011-12-29 2015-09-22 Sorin Group Italia S.R.L. Prosthetic vascular conduit and assembly method
EP2842517A1 (en) * 2011-12-29 2015-03-04 Sorin Group Italia S.r.l. A kit for implanting prosthetic vascular conduits
US10016275B2 (en) 2012-05-30 2018-07-10 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
WO2014072925A1 (en) * 2012-11-09 2014-05-15 Dp Shaw Limited Insertion tool for a heart valve
US9681952B2 (en) 2013-01-24 2017-06-20 Mitraltech Ltd. Anchoring of prosthetic valve supports
US9730791B2 (en) 2013-03-14 2017-08-15 Edwards Lifesciences Cardiaq Llc Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
US9681951B2 (en) 2013-03-14 2017-06-20 Edwards Lifesciences Cardiaq Llc Prosthesis with outer skirt and anchors
US9402614B2 (en) 2013-03-27 2016-08-02 Fehling Medical Corporation Spreader for the atrium of the heart
DE102013205519A1 (en) * 2013-03-27 2014-10-02 Fehling Instruments Gmbh & Co. Kg Spreader for the atrium of the heart
US9572665B2 (en) 2013-04-04 2017-02-21 Neovasc Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
US9468527B2 (en) 2013-06-12 2016-10-18 Edwards Lifesciences Corporation Cardiac implant with integrated suture fasteners
US9968451B2 (en) 2013-06-12 2018-05-15 Edwards Lifesciences Corporation Cardiac implant with integrated suture fasteners
US9724083B2 (en) 2013-07-26 2017-08-08 Edwards Lifesciences Cardiaq Llc Systems and methods for sealing openings in an anatomical wall
US9919137B2 (en) 2013-08-28 2018-03-20 Edwards Lifesciences Corporation Integrated balloon catheter inflation system
USD755384S1 (en) 2014-03-05 2016-05-03 Edwards Lifesciences Cardiaq Llc Stent
US9585752B2 (en) 2014-04-30 2017-03-07 Edwards Lifesciences Corporation Holder and deployment system for surgical heart valves
EP3000433A1 (en) * 2014-09-29 2016-03-30 Sofradim Production Device for introducing a prosthesis for hernia treatment into an incision
US20160089226A1 (en) * 2014-09-29 2016-03-31 Sofradim Production Whale Concept - Folding Mesh for TIPP procedure for Inguinal Hernia
US9974651B2 (en) 2015-02-05 2018-05-22 Mitral Tech Ltd. Prosthetic valve with axially-sliding frames
US20160270816A1 (en) * 2015-03-20 2016-09-22 Spinecraft, LLC MIS Access Port and Methods of Using
US9629720B2 (en) 2015-05-04 2017-04-25 Jacques Seguin Apparatus and methods for treating cardiac valve regurgitation
USD800908S1 (en) 2016-08-10 2017-10-24 Mitraltech Ltd. Prosthetic valve element
USD846122S1 (en) 2016-12-16 2019-04-16 Edwards Lifesciences Corporation Heart valve sizer
USD841813S1 (en) 2017-08-03 2019-02-26 Cardiovalve Ltd. Prosthetic heart valve element
USD841812S1 (en) 2017-08-03 2019-02-26 Cardiovalve Ltd. Prosthetic heart valve element

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US20130282112A1 (en) 2013-10-24
US8858621B2 (en) 2014-10-14
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WO2011011481A2 (en) 2011-01-27
CN102548486A (en) 2012-07-04

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