|Publication number||US7739971 B2|
|Application number||US 11/147,797|
|Publication date||Jun 22, 2010|
|Filing date||Jun 7, 2005|
|Priority date||Jun 7, 2005|
|Also published as||CA2609988A1, CA2609988C, CN101222885A, CN101222885B, EP1887982A2, EP1887982B1, US8276533, US20060276889, US20100257735, WO2006133156A2, WO2006133156A3|
|Publication number||11147797, 147797, US 7739971 B2, US 7739971B2, US-B2-7739971, US7739971 B2, US7739971B2|
|Inventors||Freeman G. Chambers, Lawrence J. Zysman|
|Original Assignee||Edwards Lifesciences Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (19), Non-Patent Citations (1), Referenced by (7), Classifications (10), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates generally to medical devices, and more particularly to a system that facilitates the assembly of components of a fabric-covered prosthetic heart valve, and associated methodology.
One of the primary classes of artificial heart valves or prostheses is a “tissue-type” or “bioprosthetic” valve having flexible leaflets that function much like those of a natural human heart valve and imitate their natural action to coapt against each other and ensure one-way blood flow. In tissue valves, a whole xenograft valve (e.g., porcine) or a plurality of xenograft leaflets (e.g., bovine pericardium) typically provide fluid occluding surfaces. Synthetic leaflets have been proposed, and thus the term “flexible leaflet valve” refers to both natural and artificial “tissue-type” valves. Two or more flexible leaflets are mounted within a peripheral stent structure that usually includes posts or commissures extending in the outflow direction to mimic natural fibrous commissures in the native aortic annulus (the same construction may be used for the mitral annulus, though it does not correspond as closely with the mitral anatomy).
In most flexible leaflet valves, metallic or polymeric structure provides base support for the flexible leaflets, which extend therefrom. One such support is an elastic “support frame,” sometimes called a “wireform,” which has a plurality (typically three) of large radius cusps supporting the inflow cusp region of the leaflets of the bioprosthetic tissue (i.e., either a whole valve or three separate leaflets). The free ends of each two adjacent cusps converge somewhat asymptotically to form upstanding commissures that terminate in tips, each being curved in the opposite direction as the cusps, and having a relatively smaller radius. The wireform typically describes a conical tube with the commissure tips at the small diameter end. This provides an undulating reference shape to which a fixed edge of each leaflet attaches (via components such as fabric and sutures) much like the natural fibrous skeleton in the aortic annulus. Some valves include polymeric wireforms rather than metallic, for ease of manufacture or other reasons. For example, U.S. Pat. No. 5,895,420 discloses a plastic wireform that degrades in the body over time. In a hybrid construction, the CARPENTIER-EDWARDS Porcine Heart Valve and PERIMOUNT Pericardial Heart Valve available from Edwards Lifesciences of Irvine, Calif. both have ELGILOY wireforms surrounded by polymer bands.
U.S. Pat. No. 4,035,849 to Angell, et al., U.S. Pat. No. 4,388,735 to Ionescu, et al., and U.S. Pat. No. 4,626,255 to Reichart, et al. disclose various flexible leaflet prosthetic heart valves with fabric-covered stents. Another example of the construction of a flexible leaflet valve is seen in U.S. Pat. No. 5,928,281 to Huynh, et al., in which the exploded view of
Components of the valve are usually assembled with one or more biocompatible fabric (e.g., Dacron, polyethylene terepthalate) coverings, and a fabric-covered sewing ring is provided on the inflow end of the stent. The fabric coverings provide anchoring surfaces for sutures to hold the flexible leaflets and sewing ring to the peripheral stent structure. In one of the assembly procedures, a tubular fabric is tightly wrapped around the undulating stent and sewn closed with one or more peripheral seams. Because of the undulating shape of the support stent, the process involves manually holding a tube of fabric around the stent and the sewing is typically accomplished in two stages; first, intermittent stitches are placed to secure the fabric in its gross position around the stent, and then a closely-spaced line of stitches is applied to complete the seam. The odd shape of the stent and the presence of two or more components being enclosed by the fabric cover necessitates that the holding and stitching operation is done manually, which makes it quite labor-intensive and time-consuming. Quality control in the manufacture of heart valves further increases the difficulty of the task because the fabric must be tightly fitted around the stent. This manual sewing procedure represents a substantial portion of the cost of the entire valve fabrication process. Furthermore, repetitive stress injuries can occur which is painful to the worker and indirectly increases the cost of making the valve. Indeed, most of the steps in assembling prosthetic heart valves are specialized, manual tasks performed in a clean room. Typically the components are held by the worker and sewn together at the same time, which is a laborious process considering the exacting nature of the quality control applied to the subsequent finished product.
There is thus a need for an improved method for assembling flexible heart valves that reduces the assembly time and reduces the instances of injury to the assembly-line workers.
The present invention provides an improved system for automatically sewing one of the stitches used in the construction of a prosthetic heart valve. In particular, the system includes a stent cloth stretching fixture for presenting heart valve components in a fixed and repeatable manner through a series of mechanisms that position, stretch, and hold the components in relative positions. The system of the present invention significantly improves speed and quality over current manual manufacturing practices. Further, the system eliminates a significant source of ergonomic stress and injury.
In accordance with one aspect of the present invention, a system for assembling components of a flexible leaflet prosthetic heart valve having a generally tubular fabric-covered leaflet support stent defining a central axis is provided. The system comprises a mandrel for retaining tension without manual assistance in a tubular length of fabric wrapped over an outflow end of a heart valve support stent, wherein the outflow end includes an undulating contour and the mandrel is adapted to retain tension in the tubular length of fabric so that it conforms to the undulating contour. The system also includes a means for forming a seam in the tubular length of fabric to enclose the stent.
The undulating contour of the outflow end may include multiple cusps curved toward an axial inflow end alternating with multiple commissures projecting toward an axial outflow end, and the mandrel includes separate clamps for the fabric corresponding to the stent cusps. There are desirably three inflow cusps and three outflow commissures alternating around a periphery of the support stent, wherein the mandrel clamps the fabric beyond an axial inflow end of the stent in peripheral locations corresponding to the cusps. Accordingly the mandrel may include an outer clamping mechanism comprising three clamp members oriented 120° apart in each of which is adapted to clamp a section of fabric, and an inner clamping mechanism comprising two disks between which one end of the tubular length of fabric may be clamped. The mandrel further may include a pedestal tube that fits on the mandrel and holds the support stent, the pedestal tube, outer clamping mechanism, and inner clamping mechanism all being relatively axially movable. In a preferred embodiment, the means for forming a seam comprises an electric sewing machine.
Another aspect of the invention is a system for assembling a prosthetic heart valve, two components of a prosthetic heart valve, a mandrel having at least one clamp for holding and maintaining in a precise positional relationship the two heart valve components, and an electric sewing machine including a needle for forming a seam in fabric to join the two components.
The two components desirably comprise a fabric covering and a generally tubular prosthetic heart valve support stent having multiple cusps curved toward an axial inflow end alternating with multiple commissures projecting toward an axial outflow end. The mandrel may be disposed beyond the inflow end of the support stent and having at least one clamp for holding and maintaining in a taut fashion the fabric covering over the outflow end of the support stent. The electric sewing machine desirably further including a shaft for rotating the commissure clamps, and wherein the needle is positioned to form a seam in the fabric covering at the inflow end of the support stent. Multiple commissure clamps hold the fabric-covered support stent commissures, and the sewing machine may include a chuck for receiving and rotating the mandrel about the stent axis. In one embodiment, the sewing machine is adapted to axially displace the support stent as it rotates, and the chuck is adapted to simultaneously rotate and axially displace the mandrel.
A method of assembling a prosthetic heart valve is also provided by the present invention. The method includes the steps of:
The mandrel further includes an inner clamping mechanism, an outer clamping mechanism, and a pedestal tube, and wherein the method further may include the steps of:
The method may further include tightening the tubular length of fabric around the support stent by relatively axially displacing the inner and outer clamping mechanisms with respect to the pedestal tube. Desirably, the inner and outer clamping mechanisms each include discrete clamps spaced apart 120° from each other that directly tension the fabric only at the cusps of the support stent. The fabric-wrapped commissures of the support stent are preferably held with a plurality of commissure clamps and the pedestal tube is separated from the support stent by relatively axially displacing the pedestal tube with respect to the commissure clamps.
The mandrel further may include an inner clamping mechanism, an outer clamping mechanism, and a pedestal tube, and wherein the method further includes:
Preferably, the mandrel is positioned within a sewing machine system adapted to rotate the mandrel about an axis, the sewing machine system further including a spindle on which are mounted a plurality of commissure clamps. The method therefore includes holding the fabric-wrapped commissures of the support stent with the commissure clamps and separating the pedestal tube from the support stent by relatively axially displacing the pedestal tube with respect to the commissure clamps. In some cases, the support stent has an undulating inflow edge, and the spindle and the mandrel are simultaneously axially displaced and rotated while forming a seam with a needle passing through the length of tubular fabric adjacent the inflow edge. The undulating inflow edge may be mapped prior to forming a seam, and movement of the spindle and mandrel may be controlled based on the mapped inflow edge.
A further aspect of the invention is a sewing machine system for forming a tubular seam in a tubular fabric piece around a medical device. The sewing machine system includes a clamp assembly for holding and rotating the tubular fabric piece wrapped around the medical device. A reciprocating needle carries a needle thread mounted for linear motion through the tubular fabric piece held by the clamp assembly. A shuttle carrying a bobbin thread is arranged to reciprocate in a linear direction perpendicular to the direction of motion of the needle and on the inside of the tubular fabric piece. A channel within which the shuttle slides passes through the tubular fabric piece, and a driving mechanism loosely couples to the shuttle and moves it back-and-forth within the channel past the needle. A driving mechanism includes a pivoting finger having a shoulder for pushing on a proximal end of the shuttle and a spherical bump that fits within a spherical depression formed in the shuttle. Preferably, the shuttle has a diametric dimension of about 8 millimeters or less.
In one embodiment, the shuttle has a pointed distal end and is arranged to pass through a loop of the needle thread to form a lock-stitch. Desirably, the shuttle comprises a housing within which is mounted a shaft that carries a coil of the bobbin thread, the shuttle further including a solid member for tensioning the bobbin thread before it pays off of the coil, the solid member being made of a material that will not deteriorate and thus contaminate a clean room environment. The pivoting finger pivots outward from an open side of the channel to expose the shuttle and facilitate exchange of bobbin threads.
In a further embodiment, the present invention provides a sewing machine system for forming a tubular seam in a tubular fabric piece around a medical device including a clamp assembly for holding and rotating the tubular fabric piece wrapped around the medical device. A reciprocating needle carries a needle thread mounted for linear motion through the tubular fabric piece held by the clamp assembly. A shuttle carries a coil of bobbin thread and reciprocates in a linear direction perpendicular to the direction of motion of the needle and on the inside of the tubular fabric piece. The shuttle has a diametric dimension of about 8 millimeters or less and carries a solid member for tensioning the bobbin thread before it pays off of the coil, the solid member being made of a material that will not deteriorate and thus contaminate a clean room environment.
The system preferably includes a channel passing through the tubular fabric piece and within which the shuttle slides, and a driving mechanism that loosely couples to the shuttle and moves it back-and-forth within the channel past the needle. The driving mechanism includes a pivoting finger having a shoulder for pushing on a proximal end of the shuttle and a spherical bump that fits within a spherical depression formed in the shuttle. Desirably, the shuttle has a pointed distal end and is arranged to pass through a loop of the needle thread to form a lock-stitch. The shuttle comprises a housing having a recess on its exterior across which a length of the bobbin thread passes. The solid member desirably comprises one of a pair of members mounted on a second shaft in the housing and biased toward one another, and between which the bobbin thread passes to impart tension thereto. The solid members may be made of acetal (Delrin), polytetrafluoroethylene (Teflon), or a suitable metal.
The present invention further provides a sewing machine system for forming a tubular seam in a tubular fabric piece. The sewing machine system includes a clamp assembly for holding and rotating the tubular fabric piece. A reciprocating needle carrying a needle thread mounts for linear motion through the tubular fabric piece held by the clamp assembly. A shuttle carrying a bobbin thread is arranged to reciprocate in a linear direction perpendicular to the direction of motion of the needle and on the inside of the tubular fabric piece, the shuttle having a diametric dimension of 8 mm or less. Desirably, the shuttle has a pointed distal end and is arranged to pass through a loop of a length of thread carried by the needle to form a lock-stitch. The system further may include a stationary channel passing through the tubular fabric piece and within which the shuttle slides, and a driving mechanism that loosely couples to the shuttle and moves it back-and-forth within the channel. Preferably, the driving mechanism includes a pivoting finger having a shoulder for pushing on a proximal end of the shuttle and a spherical bump that fits within a spherical depression formed in the shuttle. In one embodiment, the shuttle comprises a housing within which is mounted a bobbin shaft that carries a coil of the bobbin thread. At the same time the shuttle also includes a second shaft having a pair of members biased toward one another and between which the bobbin thread passes to impart tension thereto. The system further may include a mechanism for rotating and axially displacing the clamp assembly.
In accordance with a still further aspect, the present invention provides a method of assembling a prosthetic heart valve, including providing a generally tubular heart valve support stent that includes a first edge and an axially-opposite second edge. A tubular length of fabric is wrapped over the first edge of the support stent such that two free ends of the tubular length of fabric continue past the second edge. Tension is retained in the tubular length of fabric such that the fabric is held tautly along the first edge. The peripheral contour of the second edge of the support stent is mapped with an imaging system, and then a seam is formed in the tubular length of fabric closely adjacent the second edge of the support stent using an automated sewing system having a needle whose position relative to the second edge is responsive to the mapped contour of the second edge. Desirably, the second edge of the support stent is an inflow edge that has an undulating contour, the method further including simultaneously axially displacing the support stent while forming the seam with the needle of the automated sewing system. The first edge of the support stent is an outflow edge that includes multiple cusps curved toward an axial inflow end alternating with multiple commissures projecting toward an axial outflow end, and tension is retained in the fabric without manual assistance so that the fabric conforms to the cusps and commissures of the outflow edge. Desirably, the seam is formed within about 0.030 inches (0.762 mm) of the inflow edge. In one embodiment, the imaging system comprises an ultraviolet light and a camera
A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.
The present invention provides a system for automating one or more steps of a prosthetic heart valve fabrication procedure. The steps of the procedure illustrated and described involve stretching and sewing a tubular piece of fabric around a support stent. It should be understood by those of skill in the art that the illustrated support stent is only exemplary, and the present invention can be used to cover various support stents. Furthermore, various aspects of the present invention may be used in other steps of a heart valve fabrication process. For example, mechanisms similar to those shown and described may be used to cover other parts of a prosthetic heart valve with fabric. Up to now, prosthetic heart valve assembly has been an almost entirely manual, labor-intensive process. The present invention therefore represents a pioneering effort to automate at least some of the process of assembling heart valves.
The present invention involves generally two stages: a first stage of stretching a portion of fabric around a support stent, and a second stage of fastening or sewing the fabric. Either or both of the stages may be mechanized, with the other being performed manually. Desirably, at least the first stage of stretching a portion of fabric around a support stent is mechanized such that the subsequent sewing step may be performed with a means for forming a seam in the fabric, such as with a sewing machine needle or by hand using a needle. In the context of the present invention, the term “mechanized” means that some or all of a particular step in the procedure is accomplished using mechanical means or tools. “Mechanized” does not necessarily mean “automated,” in that manual operation of the various mechanical means may be required. Ultimately, one or more steps in the procedure may be automated, or self-driven, with the mechanized portions described herein incorporated into the entire process as subcomponents. However, because of the relatively small numbers of heart valves manufactured, and the attendant care taken in the overall process, the mechanized assembly enhancements described herein may so greatly improve the efficiency and reliability of the process that complete automation will not be required.
With reference now to
The mandrel 60 comprises a base having a generally cylindrical outer housing 70 defining a cavity therewithin. A fabric clamping mechanism extends through an open mouth 72 of the housing 70 and includes an outer clamping mechanism 74 and an inner clamping mechanism 76. The outer clamping mechanism 74 actually consists of a plurality (preferably three) of separate clamp members 78 supported on stanchions 80. The inner clamping mechanism 76 is shown in more detail in
Although a complete description of the steps in a fabric covering procedure will be provided below, two early steps are illustrated in
With reference now to
FIGS. 6 and 6A-6B schematically show some of the internal details of the mandrel 60. The actuator 82 is shown rotated in opposite directions in
A number of steps in a fabric covering procedure are shown in
Next, the pedestal tube 66 passes over the free end of the fabric tube 62 into engagement with the base 110 and cylindrical boss 112, as seen in
At this stage, multiple commissure clamps 130 seen in
Once the commissures 120 are clamped, the base 110 displaces to the left which causes equivalent displacement of the pedestal tube 66. The outer and inner clamping mechanisms 74, 76 remain stationary so that the only effect is separation between the open mouth of the pedestal tube 66 and the support stent 18. The gap created between the tube 66 and support stent 18 provides space for introduction of a sewing needle 140 to form the seam 50, as in
There are a number of different automated stitches that may be performed by the sewing machine 150, including a basic chain stitch and a lock stitch. To ensure integrity of the heart valve, a lock stitch is preferred. While the present invention is believed to be the first implementation of a sewing machine for assembling heart valves, the shuttle bobbin system described below for creating a lock stitch is believed to be novel in more general terms. In particular, the use of a very small reciprocating shuttle with bobbin and corresponding method is believed to be a novel arrangement for creating lock stitch seams which is applicable to finished products other than heart valve components. For instance, tubular stent grafts requiring a fabric covering may be assembled using the system described herein.
The path of the bobbin thread 182 from the coil 192 out of the housing 188 of the shuttle 164 is seen in
The present invention is particularly well-suited for assembling components of a heart valve, which must be done under extremely sanitary conditions in a clean room, for obvious reasons. Certain means for tensioning the bobbin thread in the prior art were unsuited for such an application. For example, one prior tensioning system utilized a felt bumper that was spring-biased against the bobbin thread, and tended to collect dust and shed particles over time. The present invention solves this issue by utilizing the tensioning members 194 a, 194 b that are solid and designed not to wear and create particles. For example, the tensioning members 194 a, 194 b may be made of Delrin (acetal), Teflon (polytetrafluoroethylene), or a suitable metal. In addition, it should be understood that the particular arrangement illustrated for applying tension to the bobbin thread 182 is exemplary only, and may be replaced with an alternative, such as a leaf spring arranged to bias the bobbin thread against the inner wall of the shuttle housing 188 or other fixed structure. The shaft-mounted tensioning members 194 a, 194 b, however, are desirable because of their low cost, low radial profile, and reliability.
Another feature of the shuttle 164 is a shallow recessed region 210 formed in the exterior surface of the housing 188, as seen in
The operational sequence of the shuttle bobbin subsystem begins with the needle 140 poised above the channel 152 and the shuttle 164 retracted. The needle 140 then descends into the aligned apertures 166 in the channel 152. As the needle 140 begins to rise up or retract from the apertures 166, the loop in the needle thread 180 seen in
The aforementioned shuttle bobbin assembly is believed novel because of the small size of the shuttle 164. More particular, the fabric tube 162 generally corresponds to the diameter of the heart valve support stent 18, both of which are relatively small, about 36 mm or less in diameter. The stationary channel 152 fits within the support stent 18, and thus the shuttle 164 must be even smaller still. The diametric dimension (analogous to the diameter, or the largest diametric dimension thereof) of the shuttle 164 is about 8 millimeters or less.
As previously mentioned, the inflow edge of the support stent 18 may be serpentine, scalloped, or undulating. To accommodate this contour, the location of the inflow edge of the support stent 18 translates axially as it rotates with respect to the axially stationary sewing needle 140, or vice versa. In a preferred embodiment, both the commissure clamps 130 and mandrel 60 within the chuck 156 translate axially as they rotate and the sewing needle 140 creates the seam 50. One way to do this is through a predetermined axial movement pattern implemented by cams or other such mechanisms and based on a predicted shape of the inflow edge of the support stent 18.
However, the support stent 18 may not be manufactured to precise tolerances, and because it is desirable to form the seam 50 as close as possible to the inflow edge a more accurate registration system may be necessary. For example, prior to forming the seam 50, the support stent 18 within the fabric tube 62 may be rotated a full turn while an ultraviolet light shines on the inflow edge thereof. Certain materials used in making the support stent 18 fluoresce when illuminated with ultraviolet light so that a special camera can map and record the precise contours of its inflow edge. For example, the support stent 18 often includes a MYLAR (polyethylene terephthalate) band which efficiently fluoresce upon exposure to ultraviolet light. Once the contour of the inflow edge of the particular support stent 18 is known, the sewing operation can commence that contour fed to a computer that controls axial movement of the spindle-mounted commissure clamps 130 and mandrel 60.
More particularly, an imaging system including an illumination component 240 and a recording component 242 maps the edge 234. In one exemplary embodiment, the illumination component 240 comprises an ultraviolet light that shines on the edge 234 and causes a portion of the stent 230 to fluoresce. Often, heart valve stents are made with polymers such as Mylar that can be designed to fluoresce under ultraviolet light. Although a fabric tube surrounds the stent 230, the edge 234 can be seen because of its fluorescence. The viewing camera 242 records the contours of the edge 234 as it is rotated, and the information is fed into a microprocessor 244, which ultimately controls the movement of the sewing machine components. In this manner, the precise contour of each individual stent 230 can be measured just prior to the fabric tube being sewn therearound. This ensures that seam can be formed very close to the edge 234, preferably within about 0.030 inches (0.762 mm). Because of the proximity of the seam to the edge 234, and the tension that is continually applied to the fabric tube, the fabric pulls the seam close against the inflow edge when the sewing operation is done.
The above description provides the essential elements of forming the seam 50 in the fabric tube 62. It should be noted that a number of commercial sewing machines 150 may be utilized to mechanize the final step of forming the seam 50, although certain modifications must be made such as the addition of the mandrel-holding chuck 156. The portion of the system comprising the axially moving shuttle 164 and sewing head 154 may be part of a zig-zag shuttle sewing machine which makes use of an archway shuttle. Conventional shuttle machines incorporate a dwell in the reciprocal motion of the sewing needle 140, and the particular machine used in the present system desirably includes a stop motion dwell for the needle 140. Such sewing machines can be obtained from Sew Fine, LLC of San Francisco, Calif. (www.Alsew.com).
It will also be appreciated by those of skill in the relevant art that various changes may be made to the examples and embodiments of the invention described in this provisional application, without departing from the intended scope of the invention. The particular embodiments of the invention described herein are thus to be understood as examples of the broader inventive concept disclosed in this application.
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|U.S. Classification||112/475.01, 623/2.1, 112/475.17, 112/475.14|
|International Classification||D05B35/00, A61F2/24|
|Cooperative Classification||Y10T29/49405, A61F2/2415, Y10T29/53552|
|Jun 7, 2005||AS||Assignment|
Owner name: EDWARDS LIFESCIENCES CORPORATION, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ZYSMAN, LAWRENCE J.;CHAMBERS, FREEMAN G.;REEL/FRAME:016679/0345;SIGNING DATES FROM 20050524 TO 20050602
Owner name: EDWARDS LIFESCIENCES CORPORATION,CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ZYSMAN, LAWRENCE J.;CHAMBERS, FREEMAN G.;SIGNING DATES FROM 20050524 TO 20050602;REEL/FRAME:016679/0345
|Dec 23, 2013||FPAY||Fee payment|
Year of fee payment: 4