Unlted States Patent
`[19]
`[11] Patent Number:
`5,972,028
`
`Rabenau et al.
`[45] Date of Patent:
`Oct. 26, 1999
`
`US005972028A
`
`[54]
`
`[75]
`
`STENT HOLDER/COMPRESSION
`INSTRUMENT
`
`Inventors: Richard Rabenau, Birmingham;
`Rowland W. Kanner, Guntersville;
`Fred E. Williams, Jr., Arab, all Of Ala.
`
`[73] Assignee: Atrion Medical Products, 1119-, Arab,
`Ala.
`
`[21] Appl. No.: 09/006,748
`.
`Flled:
`
`[22]
`
`Jan. 13’ 1998
`Related US. Application Data
`[60]
`Provisional application No. 60/061 302 Oct. 7 1997.
`’
`’
`’
`[51]
`Int. Cl.6 ........................................................ A61F 2/06
`[52] us. Cl. ................................. 623/1
`
`[58] Field of Search ............................ 623/1, 11, 12;
`
`
`60 / , 8, 194, 195, 198; 604/104
`
`[56]
`
`References Cited
`
`.
`
`us PATENT DOCUMENTS
`5,168,757 12/1992 Rabenau et a1.
`.
`5,378,237
`1/1995 Boussignac et a].
`.
`5,484,449
`1/1996 Amundson et a].
`5,626,604
`5/1997 Cottone ....................................... 606/1
`5,628,754
`5/1997 SheVlin
`606/195
`576627703
`9/1997 Yurek -------
`606/195
`gaggaéig
`$133; iii?
`”””” 232;;
`5:738:674
`4/1998 Williams ..
`606/108
`
`5,746,764
`5/1998 Green .......
`606/194
`7/1998 Schatz ..................................... 606/108
`5,785,715
`
`
`
`5,868,753
`
`2/1999 Schatz ..................................... 606/195
`.
`.
`.
`.
`Prtmary Exammer—Mlchael J. Mllano
`Attorney, Agent, or Firm—Trexler, Bushnell, Giangiorgi &
`Blackstone, Ltd
`[57]
`
`ABSTRACT
`
`A novel stent compression instrument is used for holding a
`stent therein during shipping to a hospital and for thereafter
`crimping the stent onto a balloon catheter. The stent com-
`pression instrument includes a body having a central bore; a
`flexible diaphragm having an aXial
`lumen and mounted
`within the body central bore, thereby defining a chamber
`between the body and the. diaphragm, and first and second
`seallng structures for provldlng seals at opposite ends of the
`chamber. The diaphragm ls formed from a generally tubular,
`thin wall
`into which the stent
`is placed therein and is
`expandable under a negative pressure condition to expand
`within the body and compressible under pressure to Crimp
`the stent onto a balloon catheter. Holding structure, which is
`formed from at least one thickened wall portion along the
`length of the diaphragm wall, is associated with the dia-
`phragm for holding the stent therewithin and to prevent
`movement of the stent once positioned therewithin when the
`diaphragm is subjected to a negative pressure condition. In
`the preferred embodiment, positioning structure is provided
`which is formed from a thickened wall portion along the
`length of the diaphragm wall which is spaced from the
`holding structure, is also associated with the diaphragm for
`positioning the stent within the lumen and preventing the
`further aXial movement of the stent relative to the lumen
`When the Stem IS placed therem‘
`
`58 Claims, 10 Drawing Sheets
`
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`Edwards Lifesciences v. Boston Scientific
`
`IPR2017-00444 EX. 2044
`
`US. Patent N 0. 6,915,560
`
`Page 1 of 21
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`Page 1 of 21
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`

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`US. Patent
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`Oct. 26, 1999
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`Oct. 26, 1999
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`Page 3 of 21
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`US. Patent
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`Oct. 26, 1999
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`US. Patent
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`Oct. 26, 1999
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`Sheet 4 0f 10
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`5,972,028
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`US. Patent
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`Oct. 26, 1999
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`US. Patent
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`Oct. 26, 1999
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`5,972,028
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`Page 7 of 21
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`

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`US. Patent
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`Oct. 26, 1999
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`Sheet 7 0f 10
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`5,972,028
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`

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`US. Patent
`
`Oct. 26, 1999
`
`
`Sheet 8 0f 10
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`5,972,028
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`Page 9 of 21
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`US. Patent
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`Oct. 26, 1999
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`Sheet 9 0f 10
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`5,972,028
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`

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`US. Patent
`
`Oct. 26, 1999
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`Sheet 10 0f 10
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`5,972,028
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`Page 11 of21
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`

`

`5,972,028
`
`1
`STENT HOLDER/COMPRESSION
`INSTRUMENT
`
`This application is based on Provisional Application Ser.
`No. 60/061,302,
`filed on Oct. 7, 1997, entitled “Stent
`Holder/Compression Instrument”.
`BACKGROUND OF THE INVENTION
`
`This invention is directed to a novel stent holder/
`compression instrument for holding and properly position-
`ing a stent therein, in which the stent can be positioned and
`held without handling by an operator. The present invention
`is further directed to a novel method for positioning a stent
`within the novel stent holder/compression instrument. This
`invention is further directed to a novel instrument which can
`
`be used to ship a stent to a hospital and thereafter be used to
`crimp the stent onto a balloon catheter.
`In order to improve the effectiveness of vascular angio-
`plasty in relieving blockage or repairing cardiovascular
`damage, an expandable stainless steel mesh stent of tubular
`configuration has been developed for vascular implantation.
`The mesh stent is used to prevent arteries from closing
`(restenosis) after vascular balloon angioplasty. The stent is
`introduced into the artery by a balloon catheter on which the
`stent has been previously crimped and the stent is then
`dilated against the vascular implantation site by expansion
`of the balloon catheter. 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.
`Astent compression instrument is disclosed in US. patent
`application Ser. No. 08/745,317 which is commonly owned
`by the assignee herein, and employs a thin, elastomeric
`tubular diaphragm inside a housing to exert uniform forces
`on a stent to compress the stent onto and around a balloon
`catheter. The disclosure of said prior application is incorpo-
`rated herein by reference. A stent in a neutral expanded state
`is placed over a balloon section of a catheter. The tubular
`diaphragm within the housing is expanded and the stent and
`balloon catheter are placed inside the diaphragm of the
`compression instrument. As pressurization forces are
`applied to the diaphragm,
`the stent
`is compressed and
`collapsed until the stent is rigidly and uniformly affixed to
`the balloon catheter. The stent loaded catheter is now ready
`for use and subsequent expansion of the stent by the catheter
`during implantation. This method requires handling of both
`the stent and the balloon catheter during the attachment or
`crimping procedure.
`Improved stents with a delicate coating which enhances
`and improves the stent’s efficacy are currently being tested
`and considered for use. The coatings could be damaged, by
`touching for example, during this handling phase.
`The present
`invention provides a novel stent holder/
`compression instrument and method for attaching an
`expandable stent to a balloon catheter which eliminates the
`handling of the stent by an operator during attachment. The
`present invention also provides a novel instrument which
`can be used to ship a stent to a hospital and thereafter be used
`to crimp the stent onto a balloon catheter. Other features and
`advantages of the present invention will become apparent
`upon a reading of the attached specification in combination
`with an examination of the drawings.
`SUMMARY OF THE INVENTION
`
`A general object of the present invention is to provide a
`novel stent holder/compression instrument which is used to
`
`5
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`hold and properly position an expandable metal mesh stent
`therein such that the stent holder/compression instrument
`can be pre-loaded at the factory with a stent.
`Another general object of the present
`invention is to
`provide a novel method of loading a stent
`into a stent
`holder/compression instrument without direct handling of
`the stent by an operator.
`Yet another general object of the present invention is to
`provide a novel instrument which can be used to ship a stent
`to a hospital and thereafter be used to crimp the stent onto
`a balloon catheter.
`
`An object of the present invention is to provide a novel
`stent holder/compression instrument which has a diaphragm
`that is designed to prevent blow-outs which tend to occur
`with thin-walled prior art diaphragms.
`A further object of the present invention to provide a
`novel stent holder/compression instrument which includes a
`guide wire that allows for easier catheter loading, maintains
`proper catheter placement, and reduces the potential for
`blow-outs of the diaphragm.
`Briefly, and in accordance with the foregoing, the present
`invention discloses a novel stent holder/compression instru-
`ment and method of use thereof, for holding a stent therein
`during shipping to a hospital and for crimping the stent onto
`a balloon catheter. The stent holder/compression instrument
`includes a body having a central bore; a flexible diaphragm
`having an axial lumen and mounted within the body central
`bore, thereby defining a chamber between the body and the
`diaphragm, and first and second sealing structures for pro-
`viding seals at opposite ends of the chamber. The diaphragm
`is formed from a generally tubular, thin wall into which the
`stent is placed therein. The tubular, thin wall is expandable
`under a negative pressure condition to expand within the
`body and compressible under pressure to crimp the stent
`onto a balloon catheter. A holding structure, which is formed
`from at least one thickened wall portion along the length of
`the diaphragm wall, is associated with the diaphragm for
`holding the stent therewithin and to prevent movement of
`the stent once positioned therewithin when the diaphragm is
`subjected to a negative pressure condition. In the preferred
`embodiment, a positioning structure, which is formed from
`a thickened wall portion along the length of the diaphragm
`wall which is spaced from the holding structure, is also
`associated with the diaphragm for positioning the stent
`within the lumen and preventing the further axial movement
`of the stent relative to the lumen when the stent is placed
`therein.
`
`To insert the stent into the novel stent holder/compression
`instrument, a negative pressure condition is formed around
`the diaphragm such that the diaphragm is expanded. Next, a
`tubular mandrel is inserted into an end of a tubular push
`sleeve and an eject rod is inserted into the opposite end of
`the tubular push sleeve until the mandrel and the eject rod
`contact each other. Thereafter, the stent is mounted on the
`mandrel without handling the stent, and the mandrel, having
`the stent mounted thereon, is inserted into the diaphragm
`lumen until the stent contacts the positioning structure in the
`preferred embodiment or the holding structure in the alter-
`nate embodiment. The stent is also lightly gripped by the
`holding structure. The push sleeve and the eject rod are then
`removed,
`leaving the mandrel and the stent within the
`diaphragm lumen. In the preferred embodiment, if initial
`insertion of the mandrel and stent does not cause the stent to
`
`engage against the positioning structure, the push sleeve is
`used to push the stent thereagainst prior to removal of the
`push sleeve and the eject rod from within the stent holder/
`
`Page 12 of21
`
`Page 12 of 21
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`

`

`5,972,028
`
`3
`compression instrument. Thus, the stent is positioned within
`the diaphragm without direct handling by an operator. The
`stent holder/compression instrument can now be shipped
`with the stent factory pre-loaded.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The organization and manner of the structure and opera-
`tion of the invention,
`together with further objects and
`advantages thereof, may best be understood by reference to
`the following description,
`taken in connection with the
`accompanying drawings, wherein like reference numerals
`identify like elements in which:
`FIG. 1 is an exploded, cross-sectional view of a novel
`stent holder/compression instrument which incorporates the
`features of the invention;
`FIG. 2 is an assembled, cross-sectional view of the stent
`holder/compression instrument shown in FIGURE 1;
`FIG. 3 is a side elevational view of a mesh stent in a
`
`neutral condition and a side elevational view of an assembly
`that
`is used to insert
`the stent within the stent holder/
`compression instrument shown in FIG. 1, with the elements
`that form the assembly shown fragmentarily;
`FIG. 4 is a partial, side elevational view of a portion of the
`assembly of FIG. 3, shown fragmentarily, and showing a
`step in the assembly thereof;
`FIG. 5 is a partial, side elevational view of a portion of the
`assembly of FIG. 3, shown fragmentarily, and showing the
`final step in the assembly thereof;
`FIG. 6 is a cross-sectional view of the stent holder/
`compression instrument shown in FIG. 1, with a diaphragm
`therein being subjected to a negative pressure condition;
`FIG. 7 is an enlarged, cross-sectional view of the stent
`holder/compression instrument shown in FIG. 1, with the
`diaphragm therein being subjected to a negative pressure
`condition and with the assembly of FIG. 5 inserted therein
`and shown partially in cross-section;
`FIG. 8 is a cross-sectional view of the stent holder/
`compression instrument shown in FIG. 1, with the dia-
`phragm therein being subjected to a negative pressure con-
`dition and with a portion of the assembly of FIG. 5 inserted
`therein and a portion of the assembly being removed;
`FIG. 9 is an enlarged cross-sectional view of a portion of
`the stent holder/compression instrument shown in FIG. 1
`having the stent positioned within the diaphragm which is
`being subjected to a negative pressure condition;
`FIG. 10 is an enlarged cross-sectional view of the portion
`of the stent holder/compression instrument shown in FIG. 9
`having the stent positioned within the diaphragm which is
`not being subjected to a negative pressure condition;
`FIG. 11 is a cross-sectional view of the stent holder/
`compression instrument shown in FIG. 1, with the dia-
`phragm therein being subjected to a negative pressure con-
`dition and having the stent positioned therein with a
`protective pin being positioned in the stent;
`FIG. 12 is a cross-sectional view of the stent holder/
`compression instrument shown in FIG. 1, with the dia-
`phragm therein being subjected to a negative pressure con-
`dition and having the stent positioned therein with a balloon
`catheter shown in side elevation, partially broken away and
`exploded from the stent holder/compression instrument;
`FIG. 13 is a cross-sectional view of the stent holder/
`compression instrument, with a second embodiment of the
`diaphragm positioned therein and which is in a neutral
`position having the stent positioned therein;
`
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`FIG. 14 is an enlarged cross-sectional view of the stent
`holder/compression instrument shown in FIG. 13, showing
`the diaphragm having the stent positioned therein and being
`subjected to a negative pressure condition;
`FIG. 15 is a cross-sectional view of a third embodiment
`
`of the diaphragm;
`FIG. 16 is a cross-sectional view along line 16—16 of
`FIG. 15;
`FIGURE 17 is a cross-sectional view along line 16—16 of
`FIG. 15;
`FIG. 18 is a cross-sectional view of the diaphragm
`inserted into the stent holder/compression instrument; and
`FIG. 19 is a portion of a tool used to form the diaphragm
`of FIG. 15.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`While the invention may be susceptible to embodiment in
`different forms, there is shown in the drawings, and herein
`will be described in detail, specific preferred embodiments
`with the understanding that the present disclosure is to be
`considered an exemplification of the principles of the
`invention, and is not intended to limit the invention to the
`embodiment or embodiments as illustrated and described
`herein.
`
`invention presents a novel stent holder/
`The present
`compression instrument 20 which is used as a protective
`shipping device for a stent 22 as well as an instrument for
`mounting the stent 22 onto a balloon catheter A and a novel
`method associated with handling, using and packaging of a
`stent 22, particularly improved stents. An improved stent 22
`of this type may have received delicate surface coating
`which enhances the stent’s efficacy.
`In addition to the
`holding function provided by the stent holder/compression
`instrument 20 of the present invention,
`the stent holder/
`compression instrument 20 is also used to uniformly crimp
`or compress the stent 22 onto a conventional balloon cath-
`eter A(see FIG. 12 for a drawing of the balloon catheter A),
`as described herein.
`
`The stent holder/compression instrument 20 includes a
`body 24 formed from a generally tubular wall 26 having an
`inner wall which defines a central through bore 28. An
`internal, elongate groove 30 is formed along the length of
`the body inner wall. A fluid coupling 32 is integrally formed
`with the tubular wall 26 and is a generally tubular member
`which communicates with the elongate groove 30 in the
`tubular wall 26 as described herein. The body 24 is prefer-
`ably plastic and is molded to withstand internal pressures of
`450 psi or greater during the stent compression operation.
`An elongated, flexible, generally tubular diaphragm is
`mounted within the central bore 28 of the body 24. A first
`embodiment of the diaphragm 34 is shown in FIGS. 1, 2 and
`6—12, a second embodiment of the diaphragm 34a is shown
`in FIG. 13 and a third embodiment of the diaphragm 34b is
`shown in FIGS. 15—18. Like elements in each embodiment
`are denoted with like reference numerals with the elements
`
`of the second embodiment having an “a” after the numeral
`and the elements of the third embodiment having a “b” after
`the numeral.
`Attention is now directed to the first embodiment of the
`
`diaphragm 34 which is shown in FIGS. 1, 2 and 6—12. The
`ends of the diaphragm 34 are sealed to the body 24 as
`described herein to form a pressure chamber 36 between the
`diaphragm 34 and the body 24, see FIG. 2. The diaphragm
`34 has an elongated, thin wall section 38 along a central
`
`Page 13 of21
`
`Page 13 of 21
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`

`

`5,972,028
`
`5
`portion thereof which is generally tubular and which is
`integrally formed with first and second end sections 40, 42,
`respectively. A central through lumen 44 extends axially
`along the length of the diaphragm 34. The diaphragm 34 is
`formed from an elastomer, preferably silicone and prefer-
`ably G.E. L.I.M. silicone rubber, durometer 25-55 shore A,
`capable of withstanding a 450 psi or greater pressure exter-
`nally applied for transmission to the stent 22 inserted within
`the diaphragm 34 during the stent compression operation as
`described herein.
`
`The first end section 40 of the diaphragm 34 is formed
`from an elongated, generally annular wall 46 which has an
`inner diameter that is greater than the inner diameter of the
`central wall section 38. The wall which forms the generally
`annular wall 46 is thickened relative to the wall that forms
`the central wall section 38 for reasons described herein. A
`
`connecting wall 48 tapers gradually from the enlarged,
`generally annular wall 46 to the central thin wall section 38.
`An annular sealing ring 50 is provided at the opposite end of
`the wall 46 and extends generally perpendicular to the wall
`46. The inner diameter of the portion of the diaphragm
`lumen 44 in the wall 46 is greater than the inner diameter of
`the lumen 44 in the central wall section 38 and the inner
`
`10
`
`15
`
`20
`
`diameter of the lumen 44 gradually tapers in the connecting
`wall 48 from the enlarged inner diameter in the wall 46 to
`the smaller inner diameter in the central wall section 38.
`
`25
`
`6
`78 at the point at which the sealing ring 50 is compressed
`between the ferrule 66 and the body 24 to create a pressure
`point seal reducing compression forces against the cap snap
`feature and improving the seal between the sealing ring 50
`and the body 24.
`An L-shaped, small diameter passageway 80 is provided
`through the ferrule 66 for attachment of a thin, L-shaped
`guide wire 82 thereto. One leg of the passageway 80 extends
`through the center of the second and third portions 56, 58
`and the other leg of the passageway 80, which is perpen-
`dicular to the first leg, extends through the first portion 54.
`The corresponding legs of the L-shaped guide wire 82 are
`seated within the legs of the L-shaped passageway 80. The
`L-shaped guide wire 82 is thin, preferably approximately
`0.014 to 0.018 inches in diameter, and has a diameter which
`is equal to the inner diameter of the L-shaped passageway 80
`at the end surface 60 so as to provide a tight fit between the
`L-shaped guide wire 82 and the L-shaped passageway 80.
`The one leg of the guide wire 82 extends through the entire
`length of the diaphragm lumen 44 such that the leg extends
`outwardly from the opposite end of the stent holder/
`compression instrument 20.
`The second end section 42 of the diaphragm 34 is formed
`from an elongated annular wall 84 which has an outer
`diameter that is greater than the central wall section 38. A
`connecting wall 86 tapers gradually from the annular wall 84
`to the central wall section 38. The wall which forms the
`annular wall 84 is thickened relative to the wall that forms
`the central wall section 38 and has a portion 88 which is
`thickened even more than the remainder of the annular wall
`
`84 proximate to the tapered connecting wall 86 for reasons
`more thoroughly described herein. The thickened wall por-
`tion 88 is thickened 0.02 inches more in this area relative to
`
`the remainder of the annular wall 84. An annular sealing ring
`90 is provided at the opposite end of the annular wall 84 and
`extends generally perpendicular to the annular wall 84. The
`inner diameter of the portion of the diaphragm lumen 44 in
`the annular wall 84 is greater than the inner diameter of the
`lumen 44 in the central wall section 38 and the inner
`
`As shown in FIG. 2, a plastic ferrule 52 is inserted into the
`portion of the diaphragm lumen 44 in the wall 46 to clamp
`the sealing ring 50 and a portion of the wall 46 against the
`body wall 26 to seal one end of the pressure chamber 36
`between the diaphragm 34 and the body wall 26. The ferrule
`52 is formed from a first generally conical portion 54 having
`opposite ends, a second cylindrical portion 56 having oppo-
`site ends and which is integrally formed with one of the ends
`of the first portion 54 and has an outer diameter that is
`greater than the outer diameter of the first portion 54, and a
`third cylindrical portion 58 having opposite ends and which
`is integrally formed with the opposite end of the second
`portion 56 and has an outer diameter that is approximately
`equal to the outer diameter of the first portion 54. The
`opposite end of the third portion 58 defines an end surface
`60 upon which the balloon catheter A abuts as described
`herein. The increase in outer diameter between the first
`
`30
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`35
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`portion 54 and the second portion 56 forms a shoulder 62 on
`the second portion 56 for mating with a plastic end cap 66
`as described herein. The increase in outer diameter between
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`45
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`40
`
`diameter of the lumen 44 gradually tapers in the connecting
`wall 86 from the enlarged inner diameter in the annular wall
`84 to the smaller inner diameter in the central wall section
`
`38. The tapered connecting wall 86 tapers down gradually to
`create a funnel for loading the balloon catheter A. The
`thickened wall portion 88 forms an inner diameter which is
`smaller than the inner diameter defined by the annular wall
`84, however, the inner diameter defined by the thickened
`wall portion 88 does not impede the entry of the balloon
`catheter A therein.
`
`the second portion 56 and the third portion 58 forms a
`shoulder 64 on the second portion 56 for mating against the
`sealing ring 50 of the diaphragm 34 to sandwich the sealing
`ring 50 between the shoulder 64 and the body wall 26.
`The end cap 66 snap-fits with the body wall 26 to maintain
`the ferrule 52 in position and to maintain the clamp between
`the shoulder 64, the sealing ring 50 and the body wall 26.
`The end cap 66 includes an end wall 68 and an annular skirt
`70 which depends therefrom. The annular end wall 68 has a
`through bore 72 therethrough into which the first portion 54
`of the ferrule 52 is inserted as shown in FIG. 2. An internal,
`annular protrusion 74 projects inwardly from the annular
`skirt 70 and mates with an annular groove 76 that is provided
`in the external surface of the body wall 26 at a distance that
`is spaced from the end of the body wall 26 to provide a
`snap-fit of the end cap 66 with the body 24. The annular end
`wall 68 of the end cap 66 abuts against the ferrule shoulder
`62 when the end cap 66 is snap-fit to the body wall 26 to
`maintain the ferrule 66 within the diaphragm lumen 44 and
`to maintain the seal between the ferrule 66, the sealing ring
`50 and the body 24. The body wall 26 has a raised seal ring
`
`An open or through plastic ferrule 92 is inserted into the
`annular wall 84 of the diaphragm 34 to clamp the sealing
`ring 90 against the body wall 26 to seal the opposite end of
`the pressure chamber 36, see FIG. 2. The open ferrule 92 is
`formed from a tubular wall 94 which has an annular ring 96
`extending radially therefrom at one end thereof. A through
`bore 98 is provided through the open ferrule 92 which
`provides an access passageway for insertion of a stent 22 in
`a neutral state into the diaphragm lumen 44 as described
`herein. At the end of the tubular wall 94 opposite to the
`annular ring 96, a chamfer 99 is provided. The tubular wall
`94 of the open ferrule 92 is inserted within the annular wall
`84 such that the annular wall 84 is not compressed against
`the interior surface of the body wall 26, see FIG. 2. The
`annular ring 96 abuts against the sealing ring 90 to sandwich
`the sealing ring 90 between the annular ring 96 and the body
`wall 26.
`
`50
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`55
`
`60
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`65
`
`A plastic end cap 100 snap-fits with the body wall 26 to
`maintain the open ferrule 92 in position and to maintain the
`
`Page 14 of21
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`Page 14 of 21
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`5,972,028
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`7
`clamp between the annular ring 96, the sealing ring 90 and
`the body wall 26. The end cap 100 includes an end wall 102
`and an annular skirt 104 which depends therefrom. The
`annular end wall 102 has a through bore 106 therethrough
`that is aligned with the ferrule through bore 98 to provide an
`access passageway for the separate insertion of the stent 22
`and the balloon catheter A as described herein and with-
`drawal of the stent-loaded balloon catheter. An internal,
`annular protrusion 108 projects inwardly from the annular
`skirt 104 and mates with an annular groove 110 that is
`provided in the external surface of the body wall 26 at a
`distance that is spaced from the end of the wall 26 to provide
`a snap-fit of the end cap 100 with the body 24. The annular
`end wall 106 of the end cap 100 abuts against the annular
`ring 96 of the ferrule 92 when the end cap 100 is snap-fit to
`the body 24 to maintain the ferrule 92 within the diaphragm
`lumen 44 and to maintain the seal between the ferrule 92, the
`sealing ring 90 and the body 24. The body wall 26 has a
`raised seal ring 112 at the point at which the diaphragm
`sealing ring 90 is compressed between the ferrule 92 and the
`body 24 to create a pressure point seal reducing compression
`forces against the cap snap feature and improving the seal
`between the sealing ring 90 and the body 24.
`Before insertion into the stent holder/compression instru-
`ment 20, the diaphragm 34 is shorter in length than the
`length shown in the drawings. When the diaphragm 34 is
`inserted and held in position by the respective ferrules 52, 92
`and respective end caps 66, 100,
`the diaphragm 34 is
`stretched to provide the thinned-down central wall section
`28 that makes expansion of the diaphragm 34 during a
`negative pressure condition more uniform. It has been found
`that for GE. L.I.M. silicone rubber having a durometer of
`25-55 shore A, the diaphragm 34 is to be stretched by a
`minimum of 25% stretch, with 31%—38% being preferred, of
`its overall length. One of ordinary skill in the art would
`recognize that
`for different materials and for different
`durometers, the amount of stretch could vary. The wall of the
`central wall section 38 of the diaphragm 34 is preferably
`about 0.010 inches after stretched. When the diaphragm 34
`is stretched, the diaphragm’s inner diameter is reduced down
`to approximately the stent’s proper compressed outer diam-
`eter. This eliminates wrinkles on the diaphragm 34 when the
`stent holder/compression instrument 20 is pressurized to
`crimp the stent 22 down onto the balloon catheter A, thus
`keeping surface contact between the diaphragm 34 and the
`stent 22 uniform and circumferentially continuous.
`The first embodiment of the diaphragm 34 includes a
`holding structure 114 for lightly gripping the stent 22 when
`it is placed within the diaphragm lumen 44 even when the
`diaphragm 34 is subjected to a negative pressure condition
`as described herein to hold the stent 22 in its original placed
`position. The first embodiment of the diaphragm 34 also
`includes a positioning structure 116 for properly positioning
`the stent 22 within the diaphragm lumen 44 during original
`placement of the stent 22 therein.
`The holding structure 114 is formed from a thickened wall
`portion 118 which is integrally formed with the diaphragm
`34 along the length of the thin central wall section 38 and
`extends radially therefrom. The thickened wall portion 118
`is continuous around the circumference of the central wall
`
`section 38. The thickened wall portions 118 contacts the
`inner wall which defines the body bore 28 when the dia-
`phragm 34 is subjected to a negative pressure condition or
`when the diaphragm 34 is at rest and is not subjected to a
`negative pressure condition as described herein. The thick-
`ened wall portion 118 does not extend into the groove 30 and
`therefore, does not interfere with the transmission of fluid,
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`10
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`15
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`20
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`25
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`30
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`35
`
`40
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`45
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`50
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`55
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`60
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`65
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`8
`such as air or a liquid, such as saline solution or other like
`liquids, (both of which are used as described herein), along
`the groove 30.
`The positioning structure 116 is formed from a thickened
`wall portion 120 which causes a restriction 122 in the central
`section 38 of the diaphragm 34. The thickened wall portion
`120 contacts the inner wall of the diaphragm 34 that defines
`the body bore 28 and the thickened wall portion 120 defines
`an inner diameter that is smaller than the outer diameter of
`
`the stent 22 in a neutral state that is to be placed and held in
`the diaphragm 34. The thickened wall portion 120 does not
`extend into the groove 30 and therefore, does not interfere
`with the transmission of fluid along the groove 30. The
`thickened wall portion 120 may extend circumferentially
`around the central wall section 38 or may be formed from a
`plurality of thickened wall portions arranged circumferen-
`tially around the central wall section 38 so long as an inner
`diameter which is less than the outer diameter of the stent 22
`
`in the neutral state to be placed therein is formed by the
`positioning structure 116.
`The fluid coupling 32 provided on the body 24 provides
`a through port 124 which communicates with the pressure
`chamber 36 between the diaphragm 34 and the body wall 26
`for both pressurization and evacuation, that is subjecting the
`diaphragm 34 to a negative pressure condition, of the
`pressure chamber 36 by a coupled syringe instrument,
`shown only partially at 126. The syringe instrument 126 is
`coupled to the fluid coupling 32 and is employed for both
`pressurizing and depressurizing the operating fluid, i.e. air or
`liquid as described herein, within the stent holder/
`compression instrument 20, as more fully described herein-
`after. A preferred syringe instrument 126 of the type which
`features a quick release mechanism which allows precise
`