US20110022165A1 - Introducer for prosthetic heart valve - Google Patents

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 inFIG. 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 inFIG. 1.
• FIG. 11 illustrates another procedure for implanting a prosthetic aortic valve into the heart using the introducer shown inFIG. 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 inFIG. 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 toFIGS. 1 and 2, an introducer10, according to one embodiment, comprises anelongated body12 having aproximal end14 and adistal end16. Thebody12 has a length L extending from theproximal end14 to thedistal end16. Thebody12 has aproximal opening18, adistal opening20, a central lumen, or passageway,22 extending longitudinally through the body from the proximal opening to the distal opening. Thebody12 desirably has aproximal flange24 that extends circumferentially around the proximal opening and radially outwardly therefrom. Theproximal flange24 can have an enlargedportion26 that functions as a handle for grasping and manipulating the introducer during use.
• Thebody12 in the illustrated embodiment has a generally cylindrical shape along the majority of its length and a tapereddistal end portion28 that extends about one third the length of the body. Thus, as can be seen inFIGS. 1 and 2, theproximal opening18 has a larger diameter than that of thedistal opening20. The tapereddistal end portion28 facilitates insertion of the introducer into a surgical incision, as described below. Thebody12 desirably has a plurality of angularly spaced, longitudinally extendinggaps30 defining a plurality of longitudinally extending, circumferentially arrayedfingers32. Thefingers32 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 eachgap30 can terminate at an enlargedcircular aperture34 that facilitates bending or flexing of the fingers at their proximal ends where each finger joins the remaining portion of thebody12.
• Thebody12 desirably has alongitudinal gap36 extending the entire length of the body from theproximal end14 to thedistal end16 and defininglongitudinal edges38. In the illustrated embodiment, thegap36 has a constant width from thedistal end16 to a location near the proximal end and then flares or widens from this location toward theproximal end14 to form an enlargedmouth40 of the gap at the proximal end. Thegap36 allows theintroducer10 to be easily placed around and removed from sutures and/or a delivery device, as further described below. Thegap36 also allows theintroducer body12 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, thegap36 can be referred to as a permanent gap because there is a gap or opening between thelongitudinal edges36 when the introducer is in its nonexpanded, or contracted, state shown inFIG. 1.
• In an alternative embodiment, the entire length of thegap36 or a portion thereof can be replaced with a longitudinally extending slit between the longitudinal edges38. When the body is in a non-expanded state, theedges38 can contact each other to close the slit. Because the introducer body is made of a flexible material, theedges38 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, thedistal end portion28 can be formed with a plurality of slits defining thefingers32, rather thanpermanent gaps30 between adjacent fingers as shown in the illustrated embodiment.
• Theintroducer10 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 anintroducer50, according to another embodiment. Theintroducer50 is similar to theintroducer10 shown inFIGS. 1 and 2 in most respects. Unlike theintroducer10, theintroducer50 has aflange portion52 formed with anopening54. Theopening54 can be adapted to receive the distal end of anelongated handle56 that can be used to assist in positioning and manipulating the introducer during use.
• FIGS. 4-11 illustrate the use of theintroducer10 in one specific procedure for implanting aprosthetic heart valve60 in the aortic annulus. Theprosthetic valve60 in the illustrated embodiment includes a substantially rigid, non-collapsibleannular frame62, a plurality ofleaflets64 supported by the frame, asewing ring66, and a plastically expandable stent, or support frame,68 extending downwardly from the sewing ring. Theprosthetic valve60 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. Theprosthetic valve60 can be mounted to the distal end of an elongated shaft or handle of adelivery device72. Exemplary embodiments of theprosthetic valve60 and thedelivery device72 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 inFIG. 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 sutures70 can be threaded through the periphery of the aortic annulus, extended outside of the body through the incision and then threaded through thesewing ring66 of theprosthetic valve60 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 thestent68. A greater or fewer number of implant sutures can be used in other applications.
• To assist in passing theprosthetic valve60 through the incision in the aorta using the introducer, theintroducer10 is first placed around thesutures70 and inserted through the incision. Because the introducer has agap36 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 thegap36, as depicted inFIGS. 4 and 5. Theenlarged mouth portion40 of the gap facilitates this process in that it allows the operator to more easily direct the implant sutures70 into and through thegap36.
• As shown inFIG. 6, theintroducer10 can then be inserted through the incision into the aorta. The tapereddistal end portion28 facilitates the insertion of the introducer through the incision. The introducer desirably is positioned such that thedistal end16 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 theprosthetic valve60 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 thegap36, as depicted inFIGS. 6-8. In addition thefingers32 can expand radially outwardly from each other to accommodate the passage of the valve through the tapereddistal end portion28 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 ring66 (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 inFIG. 9, the valve can be advanced out of the distal end of theintroducer10 and seated against the aortic annulus. At this time, theintroducer10 can be removed from the incision and from its position extending around thesutures70 and thedelivery device72. The introducer can be removed from its position extending around thesutures70 and thedelivery device72 by simply withdrawing the introducer laterally away from the sutures and the delivery device while directing them to pass through thegap36 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 inFIG. 9, after removing theintroducer10, theexpandable stent68 can be deployed by advancing aballoon catheter74 of the delivery device proximally relative to the valve to displace anose cone76 out of engagement with thestent68 and to position aballoon78 of the balloon catheter to extend through thestent68. Theballoon78 can then be inflated to cause thestent68 to radially expand and engage surrounding tissue. Thereafter, the balloon is deflated, thesutures70 are tied off to secure thesewing ring66 to the aortic annulus, and the delivery device is detached from thevalve60 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 thesutures70 and the radial outward force of theexpandable stent68.
• 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, likestent68 of valve60) into the patient's vasculature. When implanting a conventional surgical valve, a greater number of implant sutures70, 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, theintroducer10 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 aprosthetic valve60 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 thesewing ring66 of the valve, as described above. As shown, theintroducer10 can be placed around the sutures by passing the sutures through thegap36, and then inserting thedistal end portion28 of the introducer into the aortic root until the distal end is just above the native annulus. Theprosthetic valve60 can then be pushed through the introducer, into the aorta and into the native annulus. The valve can be secured in place by deploying thestent68 and tying off the implant sutures70, as described above. If the prosthetic valve has a diameter greater than that of the portion of the aorta through which the valve passes, theintroducer10 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 anintroducer assembly100, according to another embodiment, that can be used to introduce a prosthetic device, such as aprosthetic valve60, into the vasculature of a patient. Theassembly100 in the illustrated embodiment comprises an introducer101 (also referred to as a sleeve) and an applicator frame, or mounting frame,102 configured to mount theintroducer101 around the prosthetic valve. Theintroducer101 can comprise a tubular sleeve made of a stretchable, flexible and/or resilient material, such as a fabric. Theapplicator102 is configured to retain theintroducer101 in an expanded state having a generally cylindrical configuration to allow the prosthetic valve to be placed within the introducer during use. Theapplicator102 can comprise proximal anddistal rings104,106, respectively, interconnected by a plurality oflongitudinal members108 extending between and interconnecting the rings. Theapplicator102 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 theintroducer assembly100. In any case, as shown inFIG. 13, implant sutures70 can be threaded through the native annulus and thesewing ring66 of the valve. Theintroducer101 is first placed around theapplicator102, and theassembly100 is placed around thesutures70, as depicted inFIG. 13, by inserting the proximal ends of thesutures70 and the delivery device (the proximal ends are not shown inFIG. 13) into the distal opening of theapplicator102 and sliding the assembly downwardly to the position shown inFIG. 13. The inner diameter of the applicator102 (defined by proximal anddistal rings104,106) is dimensioned large enough to permit the valve to pass easily through the applicator.
• Referring toFIG. 14, thevalve60 can then be positioned within the expandedintroducer101. With the valve inside of theintroducer101, the introducer is removed from the applicator, such as by holding the introducer and the valve stationary and retracting theapplicator102 upwardly in the direction ofarrow110. Theapplicator102 can be removed from its position surrounding the sutures and thedelivery device72 by withdrawing the applicator upwardly beyond the proximal ends of the sutures and the delivery device. When the applicator is removed, theintroducer101 collapses around and desirably extends over and covers the entire valve such that adistal end portion112 of the introducer extends beyond the lower end of the valve, as depicted inFIG. 15.
• Referring toFIG. 16, the distal end portion of theintroducer101 is then inserted into the aortic root. Thevalve60 can then be inserted into the aortic root by maintaining slight upward tension on the introducer101 (in the direction of arrow114) while pushing downwardly on thevalve60 via the delivery device (in the direction of arrow116). 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 theintroducer101 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 thestent68 and tying off the implant sutures70, as described above.
• FIG. 18 shows anintroducer150, according to another embodiment, that can be used to introduce a prosthetic device, such as aprosthetic valve60, into the vasculature of a patient. Theintroducer150 comprises a thin-walled, generallytubular body152 defining a central lumen, or passageway,154. Theintroducer body152 is constructed from a thin membrane made of a flexible material, such as a flexible polymer, that forms a tubularouter membrane156 and a tubularinner membrane158. 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, theouter membrane156 can be turned and pushed inwardly into thelumen154 at one end of the body to become part of the inner membrane (as indicated by arrows160) while theinner membrane158 at the opposite end of the body is caused to turn and move outwardly (as indicated by arrows162) so as to become part of the outer membrane.
• In use, a prosthetic valve60 (or other prosthetic device), which can be mounted to the distal end of a delivery device as described herein, can be inserted into thelumen154 of theintroducer150. 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 theintroducer150 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, themembranes156,158 can roll relative to the valve to facilitate its passage through thelumen154.
• 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 11, wherein the sleeve comprises a fabric.

13. The method ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 19, wherein the distal end portion comprises longitudinally extending gaps between the fingers.

21. The introducer ofclaim 17, wherein the gap extends from the proximal end to the distal end.

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