(12) United States Patent
`US 7,895,876 B2
`(10) Patent No.:
`(45) Date of Patent:
`Mar. 1, 2011
`Spenser et al.
`
`US007895876B2
`
`(54) METHOD OF CRIMPING A PROSTHETIC
`VALVE
`
`(75)
`
`InVemOFSI
`
`_
`_
`361113111111 Spenser: Caesarea (1L);
`Netanel Benichou, Hof—Carmel (1L)
`
`(73) Assignee: Edwards Lifesciences Corporation,
`Irvine CA (US)
`’
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1056 days.
`
`(21) Appl. NO.Z 115441.822
`
`(22)
`
`Filed:
`
`Oct. 5, 2006
`
`(65)
`
`Prior Publication Data
`
`US 2007/0061009 A1
`
`Mar 15 2007
`a
`Related US. Application Data
`
`(51)
`
`(63) Continuation of application No. 11/517,881, filed on
`Sep. 8, 2006, now Pat. No. 7,530,253.
`(60) Provisional application No. 60/716,011, filed on Sep.
`9 2005.
`’
`Int. Cl.
`(2006.01)
`B21D 41/04
`(2006.01)
`B21C 51/00
`72/402. 72/482 1. 72/18 6
`(52) U S Cl
`(58) Field of ClaSSIficatlonSearch
`’
`i
`’ 72/40é
`72/416 452 1 452 831063101 18 6,
`72/452 9 482 1 465 1 466 8‘ '332555' 1:555'4’
`licatiorf file 1'40; 0011i lete Search histo
`'
`p
`ry.
`References Cited
`U.S. PATENT DOCUMENTS
`33/5552
`
`1,438,681 A * 12/1922 John .............
`..... 425/392
`
`2,974,367 A *
`3/1961 Doering eta.
`
`See a
`
`pp
`
`(56)
`
`............... 623/124
`
`5,992,000 A
`6,360,577 B2
`6,558,418 B2
`6,629,350 B2
`6,730,118 132 *
`6,769,161 B2
`6,925,847 B2
`693L899 B2
`6,968,607 B2
`6,988,881 B2
`7,010,953 B2
`
`11/ 1999 Humphrey et 31~
`3/2002 Austin
`5/2003 Carpentier et al.
`10/2003 Motsenbocker
`5/2004 Spenser et al.
`8/2004 Brown et a1.
`8/2005 Motsenbocker
`8/2005 G03 et 31~
`11/2005 Motsenbocker
`1/2006 Motsenbocker et 31.
`3/2006 St
`k
`. upec y
`(Continued)
`OTHER PUBLICATIONS
`
`http://Www.machines01uti0ns.org/customitoolsiequipment/
`HV200.htm, 2 pages, Aug. 22, 2006.
`
`(Continued)
`
`Primary Examiner 7 Debra M Sullivan
`(74) Attorney, Agent, or Firm 7 David L. Hauser; Guy L.
`Cumberbatch
`
`ABSTRACT
`(57)
`An ImPIOYed crimpmg mechamsm and method well-suited
`for use w1th stented prosthetic heart valves. The crimpmg
`mechanism includes a plurality ofj aws configured for linear
`non-rotational movement toward a central axis. A rotational
`plate is formed with a plurality of spiral grooves or tracks for
`engaging the jaws. Rotational movement of the spiral tracks
`produces linear movement of the jaws. Nestmg of the mner
`ends of the jaws permits each to be acted on along different
`radial lines while their inner faces move together evenly to
`reduce the crimping aperture ina smooth fashion. The crimp-
`ing mechanism is particularly well-suited foruse with stented
`prosthetic heart valves, such as a prosthetic aortic valve,
`though it can also be applied to other stented heart valves,
`venous valves, and even stent grafts which tend to be fairly
`large.
`
`16 Claims, 15 Drawing Sheets
`
`IPR2017-00444 EX. 2036
`
`Edwards Lifesciences v. Boston
`
`Scientific
`
`US. Patent No. 6,915,560
`
`
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`US 7,895,876 B2
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`U.S. PATENT DOCUMENTS
`
`OTHER PUBLICATIONS
`
`7,021,114 B2
`7,069,794 B2
`7,207,204 B2 *
`2009/0043249 A1 *
`
`4/2006 Perreault
`7/2006 Motsenbocker et 31.
`4/2007 Weber et al.
`.................... 72/402
`2/2009 Sokel
`.............................. 604/27
`
`http://Www.machinesoluti0ns.org/customitoolsiequipment/
`HV200,specs.htm, 1 page, Aug. 22, 2006.
`
`* cited by examiner
`
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`US 7,895,876 B2
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`1
`METHOD OF CRIMPING A PROSTHETIC
`VALVE
`
`RELATED APPLICATION
`
`The present application is a continuation of US. applica-
`tion Ser. No. 1 1/517,881, filed Sep. 8, 2006, now US. Pat. No.
`7,530,253, which claims the benefit of priority under 35
`U.S.C. §1 19(e) from provisional application No. 60/716,011,
`filed Sep. 9, 2005.
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`The present invention relates to a crimping device and,
`more particularly, to a method and device for crimping a
`stented prosthetic valve such as a heart valve from a large
`diameter to a smaller diameter.
`
`2. Description of the Related Art
`A stent is a generally cylindrical prosthesis introduced into
`a lumen of a body vessel via a catheterization technique.
`Stents may be self-expanding or balloon expandable. Bal-
`loon-expandable stents are typically crimped from an initial
`large diameter to a smaller diameter prior to advancement to
`a treatment site in the body. Before crimping, a balloon
`expandable stent is typically placed over an expandable bal-
`loon on a catheter shaft. In cases where the stent was manu-
`
`factured in its fully crimped diameter, the stent is expanded
`and then crimped on the balloon. To ensure safety, the crimp-
`ing process should be performed in a sterile environment.
`Over the years, attempts have been made to crimp the stent on
`a balloon during the operation in the sterile field. However,
`mo st stents are now “pre-crimped” on a suitable balloon in the
`factory and then delivered to the physician ready for use.
`One example of a crimping device based on movable seg-
`ments is disclosed in US. Pat. No. 6,360,577 to Austin. This
`crimping device uses sloped planes which force jaws to move
`from the open position to the closed position. In one primary
`shortcoming associated with this type of device, the length of
`the sloped plane is given by a whole circle divided by the
`number of activated jaws. The more jaws for crimping means
`a shorter sloped plane for activating. The drawback of this
`method is the contradiction created by the equation of 360
`degrees divided by the number ofj aws. In order to achieve a
`smooth aperture for crimping the valve a large number ofj aws
`is needed, but a long sloped plane is preferably to reduce
`circumferential resistance or friction forces. For example, a
`linear movement of 7 mm is achieved by a rotational move-
`ment of approximately 45 degrees (360 divided by 8 jaws),
`which is quite a steep slope angle that requires more turning
`force to overcome. Therefore, the effectiveness ofthis type of
`device is substantially limited.
`In recent years, a variety of prosthetic valves have been
`developed wherein a valve structure is mounted on a stent and
`then delivered to a treatment site via a percutaneous catheter-
`ization technique. Prosthetic valves are typically much larger
`in diameter relative to coronary stents. For example, a typical
`coronary stent diameter is only 1.5 to 4.0 mm in its expanded
`size, while a stented prosthetic valve diameter will typically
`be in the range of about 19 to 29 mm, at least 5 times as large
`as a coronary stent. In another difference, coronary stents are
`stand-alone devices while, in prosthetic valves, the stent func-
`tions as a scaffold to hold the valve structure. The valve
`
`structure is typically made of biological materials such as
`pericardium valves or harvested valves. For improved func-
`tion after deployment, it is often desirable to preserve such
`valves in the open (i.e., expanded) diameter inside a preserv-
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`ing solution. Using this procedure, it may be necessary to
`crimp the valve in the operation room a few minutes before
`implantation,
`therefore precluding pre-crimping by the
`manufacturer over a balloon.
`
`Due to the unique crimping requirements for stent-based
`prosthetic valves, it has been found that existing crimping
`devices configured for use with coronary stents are not suit-
`able for use with stent-based prosthetic valves. In addition, as
`discussed above, existing crimping mechanisms suffer from a
`variety of shortcomings which limit their ability to be adapted
`for use with stent-based prosthetic valves. Due to the defi-
`ciencies associated with existing crimping technology, a new
`crimping device was developed by Percutaneous Valve Tech-
`nologies, Inc. (PVT) that is better suited for use with stent-
`based prosthetic valves. This crimping device is described in
`co-owned US. Pat. No. 6,730,118 to Spenser, et al. and
`relates to a crimping device that is adapted to crimp a pros-
`thetic valve as part of the implantation procedure.
`Another version of a prosthetic heart valve crimper is mar-
`keted by Machine Solutions Inc. of Flagstaff, Ariz. The
`HV200 is a disposable crimper that uses multiple pivoting
`segments to crimp percutaneous heart valves. The Machine
`Solutions crimpers are also disclosed in US. Pat. Nos. 6,629,
`350 and 6,925,847, both to Motsenbocker. These crimping
`devices are based on segments which rotate about pivot pins
`to create radial compression. Unfortunately,
`the pivoting
`design tends to concentrate stress in certain areas of the indi-
`vidual segments, and in the mechanism for pivoting them.
`Also,
`the user must apply significant force to close the
`crimper aperture around a relatively large percutaneous heart
`valve.
`
`Although the heart valve crimping technology available to
`date provides an improvement over the existing stent crimper
`technology, it has been found that a need still exists for a more
`effective device. It is desirable that such a device be capable
`of crimping a valve from a diameter of about 29 mm to a
`crimped size of about 6 mm without requiring excessive force
`and without inducing high mechanical stresses within the
`device. It is also desirable that such a device is simple to use
`and relatively inexpensive to manufacture. It is also desirable
`that such a device be sterile and suitable for manual operation
`in a catheter lab or operating room. The present invention
`addresses this need.
`
`SUMMARY OF THE INVENTION
`
`The present invention provides a method and apparatus for
`crimping expandable prosthetic heart valves having support
`frames and stents.
`
`While the present invention is particularly well-suited for
`use with stented prosthetic heart valves, such as a prosthetic
`aortic valve, it can also be applied to other types oflarge stents
`such as coronary stents, peripheral stents, other stented heart
`valves, venous valves, and stent grafts.
`A main aspect ofthe present invention is the introduction of
`an improved crimping device and method of use, based on
`jaws with a linear movement toward a center, a stationary
`base including guidance slits facing the center, and a rotating
`mechanical member rotating around the center, the member
`including a spiral track.
`In one preferred embodiment, the jaws are activated by the
`rotating mechanical member. The forces applied to the move-
`able jaws are predominantly in the radial direction. When
`crimping a stented valve in a symmetrical way, thus reducing
`its diameter, (as opposed to crushing and flattening) the radial
`forces are efficient and effective in evenly reducing the cir-
`cumference of the prosthetic valve. Accordingly, the force
`
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`US 7,895,876 B2
`
`3
`applied to the jaws by the operator Via an additional mechani-
`cal member is in the same vector and opposite to the stents
`reaction force while being crimped. This advantageously pro-
`vides maximum efficiency to the crimping process.
`Another preferred aspect is the use of a rotating plate
`including a spiral track, as the mechanical member, which
`translates the force of the operator, to the jaws. The gradually
`spiral-sloped track, in this case 225 degrees, reduces resis-
`tance to the crimping operation such that approximately 5
`times less force is required by the operator than previous
`designs.
`Another main aspect of the present invention is the guiding
`slits which, in addition to the activating spiral track described
`above, assure that the jaws move in a linear manner. In the
`present invention, each jaw has two guiding slits, a main one
`in the center of the line of force application/reaction, and the
`other parallel to the main slit.
`Another main aspect of the present invention is the design
`ofthe spiral in a way allowing more than one thread to be used
`to activate the jaws, the benefit of this feature is both in the
`ability to build a crimper in a reasonable size and in the cost
`of the production of the crimper.
`Another main aspect of the present invention is the capac-
`ity to activate the jaws in a symmetrical way from both sides
`of the jaw, while leaving the middle section of the jaw free.
`Another main aspect of the present invention is a novel
`design that allows activating the jaws by more than one con-
`tact point, this allows applying a smaller force to each contact
`point resulting in the possibility of making the part from
`relatively inexpensive plastic materials,
`thus helping to
`reduce the overall price of the product. Making the device
`inexpensive allows making the device disposable, which is an
`important aspect of the invention.
`Another main aspect is the arrangement of the jaws from
`the aspect of their angles. Since the jaws travel inside the said
`guidance slits and are activated by the spirals, the operators
`force is translated into the jaw via the contact points. The
`selected number of jaws with a constant distance relation
`between the jaws dictates a certain angle of spiral.
`Another aspect of the crimping mechanism is a stopping
`mechanism preventing the operator from over crimping the
`device by mistake.
`In another embodiment, a crimping mechanism includes a
`rotational member activated by a rotating handle and a pinion
`gear which allows rotating the member more than 360
`degrees. The rotational member is activated by a lever handle
`and the stationary part is connected to a base. This configu-
`ration is advantageous for several reasons. For example, the
`arrangement allows a larger transmission ratio, and elimi-
`nates side forces on the whole apparatus resulting from the
`manual forces applied by the user, which tend to move the
`apparatus on the table. If the crimper is activated by two
`rotating members on both sides ofthe jaws, both members are
`connected by a bridge, which will restrict the possible move-
`ment of the handle to less than 360 degrees.
`One preferred aspect of the invention is a prosthetic valve
`crimping device capable of reducing the diameter of an
`expandable prosthetic valve having a support frame by at least
`10 mm. For example, prosthetic heart valves expand up to
`about 29 mm, and may be crimped with the device of the
`present invention down to about 6 mm, which is a 23 mm
`reduction. The device comprises a base and housing fixedly
`mounted thereto, the housing defining a central axis and
`having at least six evenly spaced spoke-like guide channels,
`the guide channels each being at least 5 mm in length. A
`plurality of circumferentially arrayed nesting jaws are axially
`and rotatably constrained by but radially movable within the
`
`4
`
`housing. Each jaw has a camming member that extends axi-
`ally into a guide channel, the number ofjaws being the same
`as the number of guide channels, eachjaw being substantially
`radially oriented and being formed of a single piece. Eachjaw
`defines an inner end that has a partial crimping surface which
`combines with the same on the other jaws to form a crimping
`aperture of variable diameter and having an axial and dimen-
`sion sufficient to crimp an expandable prosthetic valve. Each
`partial crimping surface terminates on one side at a point that
`is constrained to move along a radial line as the jaw moves
`along the guide channel. A camming plate rotates about the
`housing and has a plurality of cams, at least one for each jaw,
`which act directly on the camming members and move the
`jaws without any intervening connecting members. A manual
`actuator rotates the camming plate and simultaneously moves
`the jaws in to reduce the aperture diameter by at least 10 mm
`to crimp an expandable prosthetic valve placed within the
`aperture, and subsequently out to release the valve after
`crimping.
`Desirably, each jaw includes a linear slide that fits within
`the guide channel, and the guide channels are oriented along
`radial lines from the central axis. The camming member on
`each jaw may be located along a radial line from the central
`axis and extend through a guide channel on the housing, the
`jaw further including a linear tab parallel to but offset from the
`radial line that fits within a secondary guide channel on the
`housing. Eachjaw preferably comprises an outer headportion
`from which the camming member extends and an inner gen-
`erally circumferentially oriented finger with a recess defined
`therebetween, and wherein eachjaw nests within the recess of
`an adjacent jaw and the partial crimping surface is defined on
`a radially innermost face ofthe finger. In one embodiment, the
`housing flanks the jaws and defines guide channels on both
`axial sides thereof, and each jaw includes at least one cam-
`ming member extending on each axial side to engage a guide
`channel. Each jaw may have two camming members extend-
`ing axially from at least one side, wherein the camming plate
`includes cams that engage each of the two camming mem-
`bers. The cams and the camming plate may be spiral tracks
`that act to displace each of the camming members radially
`inward. Preferably, each camming plate includes a plurality
`of overlapping spiral tracks and each jaw includes two cam-
`ming members extending axially from at least one side into
`different spiral tracks. Each of the spiral tracks preferably
`extends angularly at least 360°.
`Another aspect ofthe invention is a prosthetic valve crimp-
`ing device capable of reducing the diameter of an expandable
`prosthetic valve having a support frame. The device includes
`a housing defining a central axis and having at least six evenly
`spaced spoke-like guide channels. A plurality of circumfer-
`entially arrayed jaws are axially and rotatably constrained by
`but radially movable within the housing. Each jaw has a
`camming member that extends into a guide channel, the num-
`ber ofjaws being the same as the number of guide channels.
`Each jaw is substantially radially oriented and formed of a
`single piece having an outer end and an inner end. Each jaw
`inner end has a partial crimping surface which combines with
`the same on the other jaws to form a crimping aperture of
`variable diameter and with an axial dimension sufficient to
`
`crimp an expandable prosthetic valve. A camming plate
`rotates about the housing and has a plurality of spiral cams
`which act directly on the camming members and move the
`jaws without any intervening connecting members. The spiral
`cams extend around the axis through an angle of at least 60°
`to provide a sufficient mechanical advantage to crimp
`expandable prosthetic valves. A manual actuator rotates the
`camming plate and simultaneously moves the jaws in to
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`US 7,895,876 B2
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`5
`crimp an expandable prosthetic valve placed within the aper-
`ture, and subsequently out to release the valve after crimping.
`In accordance with a still further advantageous aspect of
`the invention, a disposable, portable crimping system is pro-
`vided for prosthetic valves. The system includes a base and a
`valve crimper mounted on the base having a housing and a
`plurality of jaws radially movable within the housing. Each
`jaw defines an inner end that has a partial crimping surface
`which combines with the same on the other jaws to form a
`crimping aperture of variable diameter. Each jaw has an axial
`dimension sufficient to crimp an expandable prosthetic valve.
`A stop-limited actuator simultaneously moves the jaws in to
`reduce the aperture diameter by at least 10 mm to crimp an
`expandable prosthetic valve placed within the aperture, and
`subsequently out to release the valve after crimping. The
`system further has a support frame gauge mounted on the base
`having a tapered throughbore with a minimum diameter that
`is equal to the minimum aperture diameter as limited by the
`stop. Finally, a balloon gauge mounted on the base has a
`throughbore with a diameter sized to calibrate a balloon
`expanded therewithin to a maximum diameter sufficient to
`expand a prosthetic valve.
`The system further may include a stop member removably
`attached to the valve crimper, wherein the support frame
`gauge and the balloon gauge are removably mounted on the
`base. The removable stop member, support frame gauge, and
`balloon gauge may be formed in the same color distinct from
`the valve crimper. Preferably, each jaw has a partial crimping
`surface defined on an inner end and ending at a point that lies
`on a radius, the combination of all of the partial crimping
`surfaces defining the aperture, and wherein each jaw moves
`linearly along a line with the point remaining on the radius
`and the partial crimping surface not rotating. Furthermore,
`each jaw may comprise an outer head portion and an inner
`generally circumferentially oriented finger with a recess
`defined therebetween, wherein each jaw nests within the
`recess of an adjacent jaw and the partial crimping surface is
`defined on a radially innermost face of the finger.
`Another aspect of the present invention involves a method
`of selecting and utilizing a kit for preparing a prosthetic valve
`for use. The kit preferably includes a crimping mechanism
`and accessories such as, for example, a handle lever stop
`member, a balloon gauge, and/or a crimped-valve gauge.
`Each of the accessories is preferably removably attachable to
`the crimping mechanism. The stop member provides a physi-
`cal stop to limit rotation of the lever handle. The crimped-
`valve gauge is preferably mounted adjacent to the crimping
`mechanism. After the prosthetic valve is crimped, the pros-
`thetic valve is placed within the gauge to verify that its outer
`diameter is desirable. The balloon gauge provides a ring
`having an inner diameter calibrated to the desired maximum
`size of the expanded balloon used to deliver the prosthetic
`valve. The balloon gauge allows the operator to determine the
`amount of saline required to expand the balloon for proper
`deployment of the prosthetic valve in the patient.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view illustrating one preferred
`embodiment of an improved crimping mechanism.
`FIG. 2 is an exploded perspective view showing the com-
`ponents of the crimping mechanism.
`FIG. 3 is a side view illustrating the cooperation of the
`components.
`FIG. 4 is a side view illustrating the spiral track configured
`for moving the jaws.
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`6
`FIG. 5 is a side view illustrating the jaws in the closed
`position.
`FIG. 6 is an enlarged view illustrating a portion ofthe jaws.
`FIG. 7 illustrates a first cover formed with a spiral track.
`FIG. 8 is another exploded view illustrating the primary
`components of the crimping mechanism.
`FIG. 9 illustrates a single jaw configured for use with the
`crimping mechanism.
`FIG. 10a illustrates the interaction between two adjacent
`jaws.
`FIG. 10b is a side view illustrating the profile of a preferred
`jaw.
`FIG. 100 is a side view illustrating an alternative jaw tip.
`FIGS. 11a and 11b are additional exploded views.
`FIG. 12 is a perspective view illustrating one preferred
`embodiment of a crimping mechanism of the present inven-
`tion in conjunction with a set ofremovable accessories unique
`to a particular valve size.
`FIG. 13 is an exploded view ofthe accessories of FIG. 12.
`FIG. 14 is a perspective view of an exemplary prosthetic
`heart valve having an expandable support frame and a plural-
`ity of flexible leaflets therewithin.
`FIG. 15 is a side view of the prosthetic heart valve of FIG.
`14 crimped to a reduced diameter around a balloon catheter.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`The present invention provides an improved crimper for
`stents or prosthetic valves. The particularly advantageous
`features of the present crimper enable reduction in diameter
`of relatively large stents or prosthetic valves. The crimper is
`especially suited for crimping prosthetic heart valves which
`have expanded diameters significantly larger than most stents
`currently in use. According to Chessa, et al., the Palmaz-
`Genesis XD stents (Cordis J&J Interventional Systems Co.)
`are designed for an expansion range of 10-18 mm, and are
`considered as either large or extra-large stents (see, Results
`and Mid-long-term Follow-up of Stent Implantation for
`Native and Recurrent Coarctation of the Aorta, European
`Heart Journal Volume 26, No. 24, Pp. 2728-2732, published
`online Sep. 26, 2005). The most frequently used stents are
`significantly smaller, in the 3-6 mm range. Crimpers for these
`stents have proved inadequate for reducing in size even larger
`prosthetic valves, such as the stented prosthetic heart valves.
`Conversely, aspects of the present crimper may be applicable
`for use in crimping stents as well, although certain features
`described herein make it particularly well-suited for crimping
`large diameter stents, stent grafts, and prosthetic valves.
`The term “stented valve” as used herein refers to prosthetic
`valves for implant, primarily prosthetic heart valves but also
`conceivably venous valves and the like. A stented valve has a
`support frame or stent that provides primary structural sup-
`port in its expanded state. Such support frames are typically
`tubular when expanded, and may be expanded using a balloon
`or due to their own inherent elasticity (i.e., self-expanding).
`An exemplary stented valve is illustrated with respect to
`FIGS. 14 and 15, although the present invention may be
`useful for crimping other such prosthetic valves.
`With reference now to FIG. 1, one preferred embodiment
`of an improved prosthetic heart valve crimping mechanism is
`shown. The crimping mechanism is formed with twelve jaws
`1 arranged about the axis 10. The jaws are shown in a semi-
`closed position defining a variable-sized aperture between
`their inner ends. The crimping mechanism has a stationary
`portion comprising a split or two-part housing 2 and a base 4.
`The stationary portion supports first and second rotational
`
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`Page 20 of 25
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`US 7,895,876 B2
`
`7
`members or plates 3 which are rotated about a central axis 10
`by an actuator or lever handle 5.
`With reference now to FIG. 2, an exploded view of the
`crimper mechanism is provided. From this view, it canbe seen
`that the jaws 1 are arranged about the central axis 10 and that
`the two parts of the housing 2 flank the jaws on both sides.
`Each part of the housing 2 comprises a generally disk-shape
`with radially-oriented circular wall and an outer rim extend-
`ing toward the opposite housing part. The outer rims of both
`housing parts 2 contact one another and surround the jaws
`circumferentially. The assembly of the housing parts 2 there-
`fore defines a generally cylindrical cavity therewithin that
`constraints the jaws 1, however the axial dimension of the
`jaws 1 is such that they are restrained between the inner faces
`of the two circular walls of the housing parts 2 with sufficient
`clearance to enable sliding movement therein. As will be
`shown and described below, the housing parts numeral to
`rotationally constrain each of the jaws 1 so as to permit only
`radial movement.
`
`As seen in FIG. 2 and in detail in FIG. 9, each jaw 1 is
`preferably provided with a pair of guiding slides 17 out-
`wardly-directed on both axial sides near the radially outer-
`most extent of the jaw. The guiding slides 17 extend through
`and interact within guiding slits 15 in each stationary housing
`part 2 to constrain the jaws to linear sliding movement toward
`and away from the central axis 10. Secondary elongated guid-
`ing tabs 18 extend from both sides of each jaw 1 into engage-
`ment with parallel secondary slits 16 located in each station-
`ary housing part 2. All four of the guiding slides 17 and
`guiding tabs 18 in each individual jaw are parallel, as are the
`corresponding four slits 15, 16. The resulting assembly con-
`straints movement ofthe jaws 1 within the housing 2 to follow
`the slits 15, 16, which are generally radially oriented. In fact,
`the spoke-like slits 15 exist on radial lines outward from the
`center of the crimping mechanism, while the secondary slits
`16 are parallel but slightly spaced therefrom.
`Rotation of the first and second outer rotational plates 3
`causes translation of the jaws 1 and thus crimps the valve.
`Both plates 3 are journaled to rotate on the adjacent housing
`part 2 about the axis 10. The handle 5 attaches through a
`bracket arrangement to both plates 3 so as to rotate them in
`tandem. Spiral cuts, grooves or tracks 14 in each rotational
`plate 3 are provided on each side of the crimper mechanism
`for translating rotational movement of the lever handle 5 into
`linear movement of the jaws 1. The spiral tracks 14 are desir-
`ably formed between spiral walls extending inward from the
`rotational plates 3. The spiral tracks 14 interact with activat-
`ing pin-shaped camming members 11 located on both sides of
`each jaw, in particular extending outward from each guiding
`slide 17.
`
`With reference again to FIG. 4, a section of the crimping
`mechanism is illustrated through the rotational plate 3 such
`that the cooperation with the activating camming members 1 1
`can be seen. Upon rotation of the outer plates 3 (clockwise in
`this view) the spiral tracks 14a, 14b, and 140 apply a generally
`radially inward camming force, shown by the arrows 41, to
`the activating camming members 11. The lines 42 illustrate
`the instantaneous tangents to the spiral track 14, which is
`approximately perpendicular to the direction of motion (i.e.,
`toward the central axis 10) of the jaws and the activating
`camming members 11.
`The geometrical constraints produce the motion of the
`activating camming members 11, and thus the jaws 1, toward
`the central axis 10. Furthermore, the jaw motion is con-
`strained by the cooperation of the guiding slits 15, 16 and
`slides 17 and tabs 18 and by the jaw geometry itself, which
`will be further discussed with reference to FIGS. 9 and 10.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`8
`When the lever handle 5 is rotated in the direction ofthe arrow
`
`43 in FIG. 4, the rotational plates 3 rotate, thereby causing the
`spiral tracks 14 to rotate. This rotational movement of the
`spiral tracks pushes the jaws inward, thereby closing the
`aperture 50 (FIG. 5). Movement of the jaws 1 toward the
`center produces crimping the stented valve 20. FIG. 4 and
`FIG. 7 showing one of the rotational plates 3 in isolation best
`illustrate the shape and distributions of the three independent
`spiral tracks 1411, b and c, which fit geometrically the three
`sets of fourjaws described in FIG. 3.
`With reference now to FIGS. 3 and 4, a cross-sectional
`view ofthe crimping mechanism is provided wherein thej aws
`1 are shown in a partially open position. As discussed above,
`the twelve jaws 1 are arranged in a circular configuration
`around the central axis 10. The lines of movement ofthe jaws
`are shown for two jaws by the dashed lines 30, and their
`respective crimping movement directions by the arrows 31.
`The linear guiding slides 17 and tabs 18 are also seen here
`positioned within respect to the guiding slits 15 and 16. Three
`sets ofjaws numbered from 1 to 4 are illustrated. The differ-
`ence between the jaw positions relates to the placement ofthe
`camming members (see 11a-11d), two of which on the each
`side of each jaw 1 are held within the spiral tracks 14 on the
`rotational plates (see element 3 in FIG. 2). In the exemplary
`embodiment, therefore, there are four camming members 11
`acted on by four spiral tracks 14 for each jaw 1.
`In this example, there are three separate spiral tracks 14a,
`14b, 140 formed in each rotational plate 3. Each sp