United States Patent [191
`Green et a].
`
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`USOO5746764A
`[11] Patent Number:
`[45] Date of Patent:
`
`“
`
`1
`
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`
`Ill lll Ill lll Ill
`5,746,764
`May 5, 1998
`
`[54] STENT COMPRESSION INSTRUMENT
`
`[57]
`
`ABSTRACT
`
`[75] Inventors: Nicholas A. Green. Kinnelon. N.J.;
`Fred E. Williams, Jr.. Arab. Ala.
`
`[731 Assignees: Atrion Medical Products, Inc. Arab.
`Ala.; Cordis Corporation.
`Fla;
`a part interest
`
`[21]
`[22]
`
`Appl. No.2 745,317
`Filed:
`Nov. 12, 1996
`
`[63]
`[5 1]
`
`[5 8]
`
`[56]
`
`Related US. Application Data
`
`Continuation of Ser. No. 567,136. Dec. 4, 1995, abandoned‘
`
`Int. (:1.6 .................................................. .. A61M 29/00
`
`.. 606/194; 606/108
`us. or. .......... ..
`Field of Search .............................. .. 606/194. 1. 108.
`606/192. 195. 198; 604/104. 141
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,378,237
`5,484,449
`
`l/l995 Boussignacetal. ................. .. 606/194
`1/1996 Amundsen et al. .................. .. 606/194
`
`Primary Examiner—Michael Buiz
`Assistant Examiner-Kevin Truong
`Attorney, Agent, or Firm—Trexler. Bushnell. Giangiorgi &
`Blackstone. Ltd.
`
`In accordance with the present invention. a ?uid compres
`sion instrument and method for particular use in pre
`surgically securing and conforming a vascular stent upon an
`angioplasty balloon. includes a housing for containing pres
`surized ?uid and an elastic enclosing diaphragm secured
`within the housing and having an internal cavity and open
`ing arranged to receive the stent disposed on the balloon
`catheter for secured compression. A pressure chamber is
`arranged within the housing as an envelope about the
`diaphragm to enable pressurized ?uid forces Within the
`pressure chamber to be imposed upon the outer surface of
`the diaphragm and transmitted through the diaphragm
`enabling circumferential application against the inserted
`stent in order uniformly to compress the stent with corre
`spondingly secured purchase against the de?ated balloon
`surface. producing complete adhesion of the stent thereon.
`The subsequent balloon in?ation angioplasty and stent
`expansion is not impaired since the balloon remains in its
`de?ated shape with the compressed stent closely conforming
`in contour throughout the balloon‘s 360° periphery. The
`entire stent mesh is uniformly compressed down including
`the open stent ends which prevents the many tiny stent mesh
`edges from protruding out and effectively prevents both
`vascular abrasion as well as shifting of the stent on the
`de?ated balloon during the angioplasty insertion procedure.
`
`22 Claims, 5 Drawing Sheets
`
`26 24
`
`2O
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`lama.
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`H
`
`30
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`22
`
`Page 1 of 10
`
`Edwards Lifesciences v. Boston Scientific
`U.S. Patent No. 6,915,560
`IPR2017-00072 EX. 2005
`
`

`

`U.S. Patent
`US. Patent
`
`May 5, 1993
`May s, 1998
`
`Sheet 1 of 5
`Sheet 1 of s
`
`5,746,764
`
`Page 2 of 10
`
`Page 2 of 10
`
`

`

`US. Patent
`U.S. Patent
`
`May s, 1998
`May 5, 1998
`
`Sheet 2 of 5
`Sheet 2 of 5
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`5,746,764
`5,746,764
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`US. Patent
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`May s, 1998
`May 5, 1998
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`Sheet 3 of 5
`Sheet 3 of 5
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`US. Patent
`U.S. Patent
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`May s, 1998
`May 5, 1993
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`U.S. Patent
`U.S. Patent
`
`May s, 1998
`May 5, 1998
`
`Sheet 5 of 5
`Sheet 5 of 5
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`5,746,764
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`

`

`5,746,764
`
`1
`STENT COMPRESSION INSTRUMENT
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`This application is a continuation of US. patent applica
`tion No. 08/561136 ?led Dec. 4. 1995 now abn.
`
`BACKGROUND OF THE INVENTION
`The present invention relates to surgical angioplasty bal
`loon procedures and more particularly relates to ?uid com
`pression instruments for particular use in pre-surgical
`securement of an angioplasty stent onto a balloon catheter
`for subsequent implantation of the stent in an angioplasty
`procedure.
`In order to improve the effectiveness of vascular angio
`plasty in relieving blockage or repairing cardiovascular
`damage. a stainless steel mesh stent of tubular con?guration
`has been developed for vascular implantation. The stent is
`introduced by a balloon catheter on which the stent is
`inserted and expanded against the vascular implantation site.
`Precisely locating. implanting and expanding the stent
`requires that it be securely carried on the balloon catheter for
`both transport to the implantation site and expansion by the
`balloon. Mechanical crimping of the stent onto the catheter
`ized balloon is currently employed for the securement to the
`balloon. Mechanical crimping is e?ected by opening and
`closing jaws of the crimping tool. but cannot produce 360°
`circumferential uniformity in compression and conforming
`purchase of the stent to the de?ated balloon surface. As such.
`there is a danger of potential slippage of the stent on the
`de?ated balloon before or during an angioplasty procedure
`for vascular implant of the stent. Also. there is the possibility
`that the stent will not be uniformly and evenly expanded by
`the balloon catheter during expansion thereof. Moreover.
`any mesh material of the stent which is not completely
`crimped can lead to abrasion and damage to the vascular
`tissue during the stent insertion and implantation angio
`plasty procedure. These and other disadvantages are elimi
`nated by the instruments and method in accordance with the
`present invention.
`SUMMARY OF THE INVENTION
`In accordance with the present invention. a ?uid com
`pression instrument and method for particular use in pre
`surgically securing and conforming a vascular stent upon an
`angioplasty balloon. includes a housing for containing pres
`surized ?uid and an elastic enclosing diaphragm secured
`within the housing and having an internal cavity and open
`ing arranged to receive the stent disposed on the balloon
`catheter for secured compression. A pressure chamber is
`arranged within the housing as an envelope about the
`diaphragm to enable pressurized ?uid forces within the
`pressure chamber to be imposed upon the outer surface of
`the diaphragm and transmitted through the diaphragm
`enabling circumferential application against the inserted
`stent in order uniformly to compress the stent with corre
`spondingly secured purchase against the de?ated balloon
`surface. producing complete adhesion of the stent thereon.
`The subsequent balloon in?ation angioplasty and stent
`expansion is not impaired since the balloon remains in its
`de?ated shape with the compressed stent closely conforming
`in contour throughout the balloon’s 360° periphery. The
`entire stent mesh is uniformly compressed down including
`the open stent ends which prevents the many tiny stent mesh
`edges from protruding out and effectively prevents both
`vascular abrasion as well as shifting of the stent on the
`de?ated balloon during the angioplasty insertion procedure.
`
`2
`In one embodiment. the housing and the enclosing dia
`phragm have tubular con?gurations with an annular pressure
`chamber de?ned between the tubular housing wall and the
`tubular elastic diaphragm. The ends of the tubular dia
`phragm are sealed to the housing wall forming the ends of
`the pressure chamber. One end of the housing and dia
`phragm seal has an access passageway for insertion and
`withdrawal of the balloon catheter carrying the stent into the
`diaphragm lumen. Hydraulic or pneumatic ?uid pressuriza
`tion of the compression chamber and evacuation are pro
`vided by a syringe-type ?uid control instrument coupled to
`a conduit through the housing. In the preferred. illustrated
`embodiment. the pressurization of the diaphragm is attained
`with a ?uid medium such as air or a liquid. such as sterile
`saline. It is envisioned. however. that other media capable of
`transmitting pressure uniformly may be developed and uti
`lized as an equivalent to ?uid medium discussed hereinafter.
`
`20
`
`25
`
`30
`
`35
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`45
`
`50
`
`55
`
`65
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of vascular stent device
`disengaged from an angioplasty balloon catheter device;
`FIG. 2 is an assembled view of the stent mounted on the
`balloon catheter shown in FIG. 1;
`FIG. 3 is a perspective view of one embodiment of the
`?uid compression instrument in accordance with the present
`invention. which is coupled to a ?uid supply syringe and
`further shows the assembled stent upon the balloon catheter
`of FIG. 2 preparatory to insertion into the ?uid compression
`instrument;
`FIG. 4 is an exploded sectional view of the ?uid com
`pression instrument shown in FIG. 3;
`FIG. 5 is a sectional view of the assembled ?uid com
`pression instrument of FIGS. 3 and 4 which has been
`fragmented into two longitudinal portions for comparison of
`both normal atmospheric pressure condition and partial
`evacuation conditions within the instrument;
`FIG. 5A is a sectional view taken along a plane indicated
`by line SA-SA in FIG. 5;
`FIG. 6 is a sectional view similar to FIG. 5 showing ?uid
`pressurization condition within the instrument and the com
`pressed condition of an inserted stent uniformly compressed
`into conforming securement onto the balloon catheter;
`FIG. 7 is a sectional view similar to FIG. 6 showing an
`evacuation condition within the instrument following the
`compression condition of FIG. 6. and withdrawal of the
`compressed stent/balloon assembly following the compres
`sion operation of the instrument;
`FIG. 8 is a fragmentary. sectional view showing a portion
`of a second embodiment of a ?uid compression instrument
`according to the invention. showing a movable seal assem
`bly therein; and
`FIG. 9 is a view similar to FIG. 8 showing the sealed
`condition of the movable seal assembly in which an inserted
`catheter tube is supported during high pressure. compression
`operation of the instrument.
`
`DETAILED DESCRIPTION OF THE
`ILLUSTRATED EMBODIMENT
`Referring to FIGS. 1 and 2. a balloon-expandable “stent"
`Ahaving a conventional. stainless steel. slotted tubular mesh
`con?guration is shown in an unexpanded or intermediate
`condition. The stentA is slipped onto a de?ated angioplasty
`balloon B and catheter C unit. the stent A being held on the
`balloon initially in simple frictional ?t. In accordance with
`the present invention. the frictional fit and the conformity of
`
`Page 7 of 10
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`5,746,764
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`3
`the stent A to the de?ated balloon B with uniform cohesive
`purchase therebetween are improved by a ?uid compression
`instrument illustrated in one embodiment generally desig
`nated by a reference character 10 shown in FIG. 3. A ?uid
`pressurization syringe 12 is coupled at 14 to the instrument
`housing 16 and employed for both pressurizing and depres
`surizing the operating ?uid. typically a saline solution within
`the compression instrument 10. as more fully described
`hereinafter. A preferred syringe instrument of the type
`employed in angioplasty balloon in?ation features a quick
`release mechanism which allows precise control of both
`initial and ?nal ?uid pressurization is described for example
`in U.S. Pat. No. 5.168.757.
`As shown in FIG. 3. the stent A slipped over the balloon
`B are together inserted into the compression instrument 10
`‘ wherein the circumferentially uniform compression of the
`stent produces the corresponding uniformly cohesive pur
`chase of the stent onto the de?ated balloon. Thereafter. the
`compressed stent and balloon are removed from the com
`pression instrument 10 and are then ready for a surgical
`angioplasty implantation wherein the uniformly compressed
`stent on the de?ated balloon enables precise location of the
`implanted stent in the vascular implantation site.
`Referring now to FIGS. 4 and 5. the compression instru
`ment 10 includes an elongate. tubular main housing body 16.
`with an internal. elongate vent or pressure distribution
`groove 11 formed therein. The tubular housing 16 is molded
`to withstand internal pressures of 450 psi or greater during
`the stent compression operation. A tubular. elastic dia
`phragm generally designated 20 is mounted within the
`housing bore 18. The tubular diaphragm 20 is molded from
`elastomer capable of withstanding a 450 psi or greater
`pressure externally applied for transmission to the stent A
`inserted within the diaphragm lumen 22 during the stent
`compression operation. The diaphragm 20 has an enlarged
`annular wall 24 at one end having an opening which is
`sealed by an inserted ferrule plug 26. The ferrule plug 26 has
`a generally cone-shaped con?guration with a closed. pro
`jecting apex 28. The annular diaphragm endwall 24 is
`stretched over the ferrule plug 26 and clamped between the
`internally projeding ferrule plug and the tapering housing
`rim portion 17 to close and seal one end of an elongate.
`annular pressure chamber 30 formed between the internal
`housing bore wall 18 and the tubular wall of the diaphragm
`270. In the illustrated embodiment. a housing cap 32 is snap
`?t at bead 34 into a peripheral housing groove 36 to maintain
`end clamping by the cap 32 against an end ?ange 27 formed
`on a ferrule plug 26 and sealing clamp of the ferrule plug 26
`against the diaphragm wall portion 24. The initial or unex
`panded internal diameter of the lumen 22 is slightly less than
`the desired ?nal diameter of the stent A. once compressed
`onto the balloon catheter B.
`At the opposite. open end 19 of the housing 16. the tubular
`diaphragm 20 has an enlarged annular endwall 25 into which
`an open or through passageway ferrule generally designated
`38 is inserted to clamp the annular diaphragm wall 25
`against the rim of the housing opening 19 which seals the
`adjacent end 31 of the pressure chamber 30. The passageway
`ferrule 38 has a through bore 40 which provides an access
`passageway for insertion of the uncompressed stentA on the
`balloon B into the lumen 22 of the tubular diaphragm 20 as
`shown in FIG. 5. The end cap 42 is snap ?t at 44 to the
`housing to maintain end clamping against an end ?ange 41
`formed on the ferrule 38 and sealing clamp of the diaphragm
`wall 25. The cap 42 also has a through passageway 46
`aligned with the ferrule passageway 40 providing access
`passageway for the insertion and withdrawal of the stent!
`balloon as shown in FIGS. 5 and 7.
`
`55
`
`65
`
`4
`Referring again to FIG. 4. the ?uid coupling 14 of the
`housing 16 provides a through port 15 which communicates
`with the annular pressure chamber 30 for both pressurization
`and evacuation of the pressure chamber 30 by the coupled
`syringe 12. The elongate inward taper of the passageway
`ferrule 38 extends longitudinally beyond the transverse
`opening of the coupling port 15 in order to annularly support
`the diaphragm wall 25 and thus prevent any induced de?ec
`tion of the wall 25 which could otherwise be drawn against
`the opening of the port 15 by suction action of the evacu
`ation pressure reduced by the action of the syringe 12 in
`operation as more fully described hereinafter.
`Additionally. the raised ring forming an inlet 39 on the
`passageway ferrule 38 promotes slight stretching of the
`annular diaphragm wall 25 and facilitates expansion of the
`diaphragm 22 during the evacuation of the compression
`chamber 30 by the syringe action. The tapered diaphragm
`portion 23 leading to the endwall portion 25 helps to prevent
`the tubular diaphragm from extruding between the stent!
`balloon A. B and the interior surface of the passageway
`ferrule 38 and eliminate a rupturing hazard during pressur
`izing operations.
`In operation to compress a stent A in uniform securement
`onto the de?ated balloon B. the ?uid syringe 12 (FIG. 3) is
`connected to the coupler 14 for example by respective luer
`couplings 48 and 50in the embodiment shown in FIG. 5. In
`a preparatory priming step. the syringe 12 first delivers
`pressurized ?uid such as distilled water or saline solution.
`through the port 15 to fill the annular pressure chamber 30
`after which the in?ator plunger is retracted until all air voids
`have been purged. Thereafter. using the syringe 12. the
`pressure chamber 30 is partially evacuated to cause the
`tubular diaphragm to expand radially the lumen 22 as shown
`in the righthand portion of the instrument 10 shown in FIG.
`5. The lefthand por1ion of FIG. 5 illustrates the normal or
`unpressurized diameter of the lumen 22. The vent groove 11
`prevents ?uid ?ow blockage due to any collapse of the
`diaphragm 20 against the housing bore wall 18 during the
`evacuating operation. The resulting dilation of the lumen 22
`allows expanded clearance for insertion of the stent/catheter
`balloon A. B to be inserted through the open. thorough
`passageway 40 as shown in FIG. 5 and entirely through
`lumen 22 until the leading or nose portion of the catheter C
`engages the projecting ferrule apex 28 at the closed end of
`the lumen 22. In order to view the insertion and passage of
`the stent/balloonlcatheter A. B. C through the lumen 22, the
`diaphragm 20 is preferably transparent and appropriately
`molded. for example from silicone elastomer.
`correspondingly. the housing wall 18 is transparent and to
`improve visibility the housing wall has a medial. reduced
`diameter portion 13 for viewing the progressive passage of
`the catheter tip C and stent A through the diaphragm lumen
`22.
`After fully inserting the uncompressed stent Alballoon B
`the syringe 12 again pressurizes the pressure chamber 30 to
`a pressure for example 300 psi to 450 psi resulting in a
`circumferentially and longitudinally uniform compression
`of the tubular diaphragm 20 which transmits the hydraulic
`pressure in the correspondingly uniform longitudinal distri
`bution of circumferential compressive forces indicated by
`arrows D along the entire length of the stent A. The
`uniformly distributed compression forces result in a com
`pression of the annular mesh wall of the stent from an
`original. uncompressed outer diameter of. for example.
`0.056 inch reduced to the compressed outer diameter
`approximately 0.050 inch using a diaphragm tube of normal.
`uncompressed diameter approximately 0.046 inch. Most
`
`Page 8 of 10
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`

`

`5
`importantly. the uniform longitudinal and radial compres
`sion transmitted by the tubular diaphragm 20 results in
`corresponding compression force distribution on the stent to
`enable the compressed mesh of the stent to closely conform
`to the surface of the de?ated balloon with maximum adhe
`sive purchase therebetween. without any exposure to hazard
`of damage from localized overcompression of the stent.
`which has occurred in prior methods of mechanically crimp
`ing the stent. Moreover. the uniformly compressed stent A -
`achieves improved purchase and grip onto the balloon B to
`10
`prevent any premature displacement of the stent along the
`balloon during subsequent surgical angioplasty procedures
`for coronary or vascular implantation of the stent.
`Additionally. the mesh body of the stent and most
`importantly. the open ends of the stent. A1 and A2. are
`uniformly compressed down against the balloon as shown in
`FIG. 6 to prevent possibility of lead or intermediate edges of
`the stent catching against the vascular wall to cause dam
`aging abrasion. thus further improving surgical safety.
`Since the mesh stent is readily compressed under the
`uniform hydraulic pressure imposed by the compression
`chamber 30. the compressed stent conforms to the de?ated
`balloon shape in seconds and is ready to be withdrawn from
`the instrument 10 facilitated by again retracting the syringe
`12 plunger to evacuate the compression chamber 30 and
`redilate the tubular diaphragm 20 as shown in FIG. 7.
`Thereafter. the compressed stent/balloon/catheter A. B. C is
`retracted from the tubular lumen 22 and removed from the
`instrument 10. ready for subsequent angioplasty procedure.
`Referring now to FIGS. 8 and 9. a second embodiment
`110 of the ?uid compression instrument in accordance with
`the present invention is shown. in which a thickened endwall
`portion 125 of the tubular diaphragm 120 is squeezed down
`to grasp and suppoa-the portion of the catheter tube C as
`shown in FIG. 9. extending through the open end 119 of the
`housing 116 from the inserted stent/balloon portions (not
`shown). The squeezed diaphragm wall portion 125 also
`forms a compression ?ange which withstands highly pres
`surized ?uid. for example. 450 psi or higher. and the grip of
`the catheter extension C prevents its movement during the
`higher pressurization as shown in FIG. 9. The compression
`?ange portion 125 is squeezed radially by longitudinal
`compression against an annular seat member 100 which ?ts
`against an internal shoulder 102 of a housing wall 116. The
`seat 100 also has an internal shoulder 104 against which the
`compression ?ange portion 125 is compressed by longitu
`dinal force imposed by translation of an open ferrule 138.
`The ferrule 138 has a threaded portion 141 threaded to
`internal cap threads 143 on the open cap 142 which is
`annularly snap-?t at 144 to allow annular rotation through
`the peripheral. snap-?t groove 117 in the housing wall 116.
`Rotation of the cap 142 facilitated by ?nger grips 145 causes
`threaded drive translation leftwardly from the position
`shown in FIG. 8 to the position shown in FIG. 9 producing
`the longitudinal compression and induced radially inward
`squeezing of the compression ?ange portion 125 of the
`tubular diaphragm 120 to produce the secured gripping of
`the catheter portion C as well as the extruded seal engage
`ment of the compression ?ange portion against the interior
`surface of the housing endwall 119. The longitudinal com
`pression of the ?ange portion 125 also forces partial extru
`sion through the hole 101 in the seat 100 as shown in FIG.
`9. The inserted catheter portion C is squeezed and supported
`by the compression of the ?ange 138. A stop portion 139 of
`the ferrule 138 travels through a keyway 147 within the cap
`142 and impinges a stop surface 152 formed on the housing
`end 119. The seat 100 has a passageway slot 106 which
`
`65
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`5.746.764
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`6
`provides ?uid communication between the ?uid pressure
`supply conduit 115 and the housing vent groove 111 extend
`ing longitudinally along the pressure chamber 130.
`After compression operation on the stent. the ferrule 138
`is unscrewed and backed off retuning to the position in FIG.
`8 to relieve the compression of the ehlstomeric spring-like
`?ange portion 125 and to release the grip of the catheter.
`allowing withdrawal of the compressed stent.
`The invention claimed is:
`1. A ?uid compression instrument for particular use in
`pre-surgically conforming and securing a vascular stent
`upon an angioplasty balloon comprising:
`a) a housing for containing a pressurized medium:
`b) an elastic enclosing diaphragm having an internal
`cavity and opening therein and arranged to receive a
`vascular stent and an angioplasty balloon inserted
`within said internal cavity. said elastic enclosing dia
`phragm being mounted within said housing; and
`c) pressure chamber structure provided by said housing
`and arranged as an envelope about said elastic enclos
`ing diaphragm for enabling containment of pressurized
`forces imposed upon an outer surface of said elastic
`enclosing diaphragm to be transmitted through said
`elastic enclosing diaphragm and circumferentially
`applied against the inserted vascular stent in order
`uniformly to compress the vascular stent into secured
`purchase against the angioplasty balloon.
`2. An instrument according to claim 1. wherein said
`elastic enclosing diaphragm comprises a tubular con?gura
`tion de?ning a lumen therein which de?nes said internal
`cavity.
`3. An instrument according to claim 2. wherein said
`pressure chamber structure is annular and is arranged cir
`cumferential to said tubular diaphragm configuration.
`4. An instrument according to claim 3. wherein said
`annular pressure chamber structure is formed radially
`between said tubular diaphragm con?guration and a sur
`rounding wall of said housing.
`5. An instrument according to claim 4. wherein said
`tubular diaphragm con?guration comprises opposite end
`portions de?ning adjacent ends of said pressure chamber
`structure.
`6. An instrument according to claim 5. wherein at least
`one of said tubular diaphragm end portions is sealed against
`said surrounding housing wall.
`7. An instrument according to claim 6. further comprising
`a seal member respectively sealing said respective tubular
`diaphragm end portion against a respective surrounding
`housing wall portion.
`8. An instrument according to claim 7. wherein said seal
`member comprises a through passageway communicating
`with said diaphragm lumen to enable access passage of the
`vascular stent therethrough into said housing and said dia
`phragm lumen.
`9. An instrument according to claim 7. further including
`a second seal member associated with the opposite tubular
`diaphragm end portion and a respective surrounding housing
`wall portion. said second seal member comprising a through
`access passageway communicating with said diaphragm
`lumen for insertion of the vascular stent therethrough into
`said housing and said diaphragm lumen.
`10. An instrument according to claim 7. further compris
`ing a clamp member clamping said diaphragm end portion
`against said surrounding housing wall to de?ne said seal
`member.
`11. An instrument according to claim 10. wherein said
`clamp member is at least partially inserted within said
`diaphragm end portion.
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`5,746,764
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`7
`12. An instrument according to claim 10. said clamp
`member comprises an integral closure portion closing an
`opening in said respective diaphragm end portion.
`13. An instrument according to claim 12. wherein said
`closure portion is at least partially inserted to plug said
`opening of said diaphragm end portion.
`14. An instrument according to claim 5. further compris
`ing a sealing element at least partially projecting into one of
`said tubular diaphragm end portions. and a ?uid conduit
`through said surrounding housing wall communicating with
`said pressure chamber structure for supply and evacuation
`therethrough of pressurization ?uid ?ow. wherein said
`inserted portion of said sealing member extends transversely
`across an opening of said ?uid conduit in order to support
`said diaphragm end portion and prevent de?ection thereof
`into said ?uid conduit opening during evacuation ?uid ?ow
`from said pressure chamber structure therethrough.
`15. An instrument according to claim 4. further compris~
`ing a ?uid conduit formed through said surrounding housing
`wall and communicating with said pressure chamber struc
`ture for pressurizing and evacuating ?uid ?ow therethrough.
`16. An instrument according to claim 1. further compris
`ing a clamp member movably mounted within said housing
`and engageable with a seal member. in order to compress
`said seal member into sealed engagement with an inserted
`component.
`17. An instrument according to claim 16. wherein said
`seal member is an integral portion of said elastic enclosing
`diaphragm.
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`25
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`8
`18. An instrument according to claim 17. wherein said
`seal member of said diaphragm has a tubular con?guration
`de?ning a lumen therein. arranged so that said compression
`by said movement of said clamp member induces radially
`squeezed contraction of said lumen and secured grasp of a
`catheter inserted through said lumen by compression of said
`sealing member. in order to support said catheter during
`highly pressurized compression of the vascular stent by said
`elastic enclosing diaphragm.
`19. An instrument according to claim 18. further com
`prising a cap member rotatably mounted on said housing and
`threaded to a threaded dn've portion of said clamp member
`to enable said movement of said clamp member by rotation
`of said cap member.
`20. An instrument according to claim 16. wherein said
`clamp member further comprises a through passageway to
`enable insertable access therethrough of the vascular stent
`and the angioplasty balloon.
`21. An instrument according to claim 1. further including
`a pressurization device for pressurization of said pressurized
`medium.
`22. An instrument according to claim 4. further compris
`ing a venting recess formed into said surrounding housing
`wall.
`
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