United States Patent
`Kuteneuer et al.
`
`[19]
`
`[54] SINGLE LAYER HYDRAULIC SHEATH
`STKNT DELIVERY APPARATUS AND
`METHOD
`[75] Inventors: Charles L. Euteneuer, St. Michael;
`Phlayne M. Fraser, Plymouth; Paul
`H. Burmeister, Maple Grove; Dean
`A. Peterson, Minneapolis, both of
`Minn.
`Scimed Lifesystems, Inc. , Maple
`Grove, Minn.
`[21] Appl. No. : 245, 919
`[22] Filed:
`May 19, 1994
`
`[73] Assignee:
`
`Related U. S. Application Data
`[63] Continuation-in-part of Ser. No. 141, 269, Oct. 22, 1993
`pending.
`. . A61M 25/00
`[51] Int. Cl. 6
`[52] U. S. Cl.
`606/198; 604/96
`[58] Field of Search . . . . . . . . . . . . . . . 606/191, 194, 108, 192,
`606/194, 195, 198, 200; 604/96, 104; 623/1, 12
`References Cited
`U. S. PATENT DOCUMENTS
`Rich et al. .
`3, 911, 927
`10/1975
`.
`4, 328, 811
`5/1982
`Fogarty
`Gould et al. .
`2/1986
`4, 572, 186
`Fogarty et al. .
`8/1986
`4, 606, 347
`Wiktor . . . . . . . . . . . . . . .
`3/1987
`4, 649, 922
`.
`4/1987
`4, 655, 771
`Wallsten
`Garza et al. .
`4, 665, 918
`5/1987
`Wiktor .
`4, 681, 110
`7/1987
`Bowden .
`4, 699, 611
`10/1987
`.
`3/1988
`4, 732, 152
`Wallsten
`.
`3/1988
`4, 733, 665
`Palmaz
`Wallsten et al. .
`7/1989
`4, 848, 343
`Chin .
`9/1989
`4, 863, 440
`10/1989
`4, 875, 480
`Imbert
`
`[56]
`
`. . . 623/1
`
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US005445646A
`[11] Patent Number:
`[45] Date of Patent:
`
`5, 445, 646
`Aug. 29, 1995
`
`4, 893, 623
`4, 950, 227
`4, 954, 126
`4, 990, 138
`5, 026, 377
`5, 061, 275
`5, 064, 435
`5, 071, 407
`5, 074, 845
`5, 078, 720
`5, 108, 416
`5, 158, 548
`5, 192, 297
`5, 201, 757
`5, 234, 457
`5, 242, 399
`5, 261, 878
`
`1/1990
`8/1990
`9/1990
`2/1991
`6/1991
`10/1991
`11/1991
`12/1991
`12/1991
`1/1992
`4/1992
`10/1992
`3/1993
`4/1993
`8/1993
`9/1993
`11/1993
`
`. . . 606/192
`. . . 606/192
`
`. . . 623/I
`
`. . . . . . .
`Rosenbluth
`Savin et al. . . . . . . .
`.
`Wallsten
`Bacich et al. .
`Burton et al. .
`Wallsten et al. .
`Porter .
`Termin et al. .
`Miraki et al. .
`Burton et al. .
`Ryan et al. . . . . . . . .
`Lau et al. .
`Hull .
`Heyn et al. .
`.
`Andersen
`Lau et al. .
`.
`Galindo
`Primary Examiner — Stephen C. Pellegrino
`Assistant Examiner — William Lewis
`Attorney, Agent, or Firm — Vidas, Arrett & Steinkraus
`ABSTRACT
`[57]
`A delivery system for implantation of a self-expanding
`stent in a vessel is consists of an elongate flexible cathe-
`ter for delivering a self-expanding
`stent to a predeter-
`in a vessel. The stent surrounds
`location
`mined
`the
`flexible catheter near its distal end and is held in a deliv-
`ery configuration where the stent has a reduced radius
`its entire axial length by a stent retaining
`along
`and
`release means. The stent retaining and release means is
`a single layer sheath retaining sleeve means for retaining
`the stent in its delivery configuration attached to a slip-
`ping sleeve means for releasing the stent to self-expand.
`A balloon may optionally be used to seat the stent in the
`vessel after self-expansion. The stent may also option-
`ally be retained by water soluble or swelling bands.
`
`.
`
`10 Claims, 10 Drawing Sheets
`
`12
`
`30
`
`14
`
`l7
`
`30
`
`20
`18
`
`22
`
`l8
`
`18
`
`20
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 1
`
`

`

`U. S. Patent
`
`Aug. 29, 1995
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 2
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`Aug. 29, 1995
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 3
`
`

`

`Aug. 29, 1995
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 4
`
`

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`Aug. 29, 1995
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 5
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`Aug. 29, 1995
`
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`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 6
`
`

`

`U. S. Patent
`
`Aug. 29, 1995
`
`Sheet 6 of 10
`
`5, 445, 646
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 7
`
`

`

`U. S. Patent
`
`Aug. 29, 1995
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 8
`
`

`

`Aug. 29, 1995
`
`Sheet 8 of 10
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 9
`
`

`

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`
`Aug. 29, 1995
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 10
`
`

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`Aug. 29, 1995
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 11
`
`

`

`5, 445, 646
`
`SINGLE LAYER HYDRAULIC SHEATH STENT
`DELIVERY APPARATUS AND METHOD
`
`RELATED APPLICATIONS
`is a continuation
`in part of co-pend-
`This application
`ing application Ser. No. 08/141, 269 filed Oct. 22, 1993,
`pending.
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates to a delivery system and
`for delivering
`method
`a stent. More
`and deploying
`relates to a delivery system
`the invention
`specifically,
`and method for delivering and deploying a self-expand-
`ing stent in a body lumen.
`2. Description of the Related Art
`Stents and delivery systems for deploying stents are a
`highly developed and well known field of medical tech-
`nology. Stents have many well known uses and applica-
`tions. A stent is a prosthesis which is generally
`tubular
`in a vessel or lumen to
`and which is expanded
`radially
`its patency. Stents are widely used
`maintain
`in body
`vessels, body canals, ducts or other body lumens.
`The preferred present stent delivery apparatus
`and
`method utilizes a self-expanding
`stent, which
`is well
`in the art. A well known self-expanding
`known
`stent is
`in U. S. Pat. Nos.
`the woven braided stent disclosed
`4, 655, 771 (Wallsten); 4, 954, 126 (Wallsten) and 5, 061, 275
`any type of self-expanding
`(Wallsten), although
`stent
`may be deployed using
`the inventive delivery system
`and method. The delivery system of the present inven-
`tion may also be used to deliver a balloon expanded
`stent and may also deliver stent grafts, which are well
`in the art.
`known
`The delivery systems for stents are generally com-
`prised of catheters with the stent axially surrounding
`the distal end of the catheter. It is highly desirable
`to
`keep the profile of the catheter as small as possible.
`Therefore, self-expanding
`stents are generally confined
`in a reduced radius for delivery to the deployment
`site.
`Once the stent
`is deployed
`the catheter
`is removed,
`the stent implanted at the desired
`leaving
`location to
`keep the vessel walls from closing.
`A variety of techniques have been developed
`for
`holding a self-expanding
`stent in its reduced configura-
`the distal end of the catheter to the
`tion while moving
`site. For example,
`in U. S. Pat. No.
`deployment
`4, 655, 771 (Wallsten), gripping members at either end of
`the stent hold the stent in an axially-elongated position,
`which causes the stent to take a reduced radius delivery
`configuration.
`Another common technique for maintaining
`the self-
`expanding stent in a reduced radius delivery configura-
`tion is using a sheath which surrounds
`the stent and
`compresses
`it around
`the catheter. This technique
`is
`in U. S. Pat. Nos. 5, 071, 407 (Terrain) and
`disclosed
`5, 064, 435 (Porter), both of which use a silicon rubber
`to compress
`sheath
`the stent. A similar
`technique
`is
`in U. S. Pat. Nos. 5, 026, 377 (Burton) and
`disclosed
`5, 078, 720 (Burton).
`A variation on surrounding
`the stent with a sheath is
`in U. S. Pat. Nos. 4, 732, 152 (Wallsten);
`disclosed
`4, 848, 343 (Wallsten)
`all of
`and 4, 875, 480 (Imbert),
`which disclose using a sleeve formed of a doubled-over
`section of membrane
`to compress and contain the stent.
`U. S. Pat. No. 5, 234, 457 discloses using a sheath
`to
`surround a mesh stent of the type disclosed in U. S. Pat.
`
`No. 4, 922, 405. However,
`in this patent the sheath is not
`used to compress
`the stent, but is used to prevent fluid
`. from accessing the stent. The stent is impregnated with
`a pure gelatin or other dissolvable material which,
`when cured, has sufficient strength
`to hold the stent in
`its reduced delivery configuration. Once the sheath
`is
`to the body
`withdrawn,
`the stent
`is exposed
`fluids
`which dissolve
`the gelatin, allowing
`the stent to self-
`expand. This reference also discloses using axial distri-
`10 bution of gelatins with different rates of thermal decom-
`position to control the physical profile of the stent as it
`expands. However, using an impregnated mesh stent
`adds several
`inconvenient manufacturing
`steps to the
`process of preparing
`the stent for implantation.
`All of the methods for delivery of a stent discussed to
`this point involve releasing
`the stent starting from one
`end of the stent, except for Anderson U. S. Pat. No.
`5, 234, 457 which can allow the stent to self-expand uni-
`formly over its entire length. An improvement
`to this
`type of deployment
`in Heyn U. S. Pat. No.
`is discussed
`5, 201, 757 which relates to medial deployment of a stent.
`Medial deployment of a stent releases the middle region
`of the stent before releasing either end of it. This tends
`to prevent stent movement during deployment.
`All of the prior art methods of containing and deploy-
`ing the self-expanding
`stent have several problems.
`First, many of the techniques
`require that movement of
`the entire sheath or exterior catheter take place to ma-
`the distal end of the catheter and effect release
`30 nipulate
`of the stent. This can be seen in Wallsten U. S. Pat. Nos.
`4, 655, 771 and 4, 954, 126 in which tubular member 23 is
`moved forward from position 22 to position 30. In Ten-
`nin U. S. Pat. No. 5, 071, 407 the sheath 32 is withdrawn
`35 proximally with respect to the stent. In Porter U. S. Pat.
`No. 5, 064, 435 the sheath 38 is withdrawn
`proximally
`with respect to the stent. Burton U. S. Pat. No. 5, 026, 377
`also moves an outer sleeve backwards
`to the
`relative
`stent. In Wallsten U. S. Pat. Nos. 4, 732, 152; 4, 848, 343,
`40 and Imbert 4, 875, 480, a hose 5 is connected to a maneu-
`the length of the catheter.
`tube 8 which runs
`vering
`Finally,
`in Heyn, finger grip 5, connected to section 58
`causes outer catheter 20 and sleeve 24 to move proxi-
`mally relative to the stent.
`In all of the cases discussed above, movement occurs
`over the entire length of the catheter between the proxi-
`mal end controlled by the physician and the distal end
`where the stent is released. This catheter movement
`in
`the vessel creates several problems. First, catheter
`50 movement can disturb or move the introducer sheath at
`the wound site where the catheter
`is inserted
`into the
`vessel. Secondly,
`the added fric-
`in tortuous anatomy
`tion caused by rubbing
`the outer catheter against
`the
`vessel, as well as the added friction created between the
`55 inner/outer
`layer interface, can make deployment diffi-
`cult. The translation of control movements
`from the
`to the distal end is imprecise,
`proximal
`jerky and
`in
`some instances
`impossible due to the increased friction
`caused by tortuosity. Thirdly,
`it-can create trauma
`to
`6p the endothelium over the entire length of the catheter.
`Another drawback
`to the prior art stent delivery
`systems discussed above is that requiring an extra sheath
`layer, sleeve layer or layered catheters (Heyn) increases
`the profile of the catheter, which
`is undesirable. The
`in U. S. Pat. No. 5, 201, 757 has a
`65 Heyn device described
`profile of 0. 12 inches (3. 048 mm). A reduction
`in profile
`of even 1F (French) is considered significant
`to those
`skilled in the art.
`
`45
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 12
`
`

`

`5, 445, 646
`
`There remains a need in the art for a stent delivery
`system in which the catheter remains stationary
`in the
`is confined to the distal end of the
`vessel and movement
`catheter to avoid disturbing
`the introducer sheath, mini-
`to the endothelium
`mize trauma
`and allow for move 5
`easier and more accurate deployment
`in tortuous anat-
`omy. Furthermore,
`there remains
`the need for a stent
`delivery catheter with a smaller profile than the prior
`art. There is also a need for an improved form of medial
`release.
`
`10
`
`SUMMARY OF THE INVENTION
`The inventive stent delivery device includes a cathe-
`ter with a stent held in a reduced delivery configuration
`for insertion and transport
`through a body lumen to a 15
`of a stent, self-
`site for deployment
`predetermined
`stent, stent graft or the like. The preferred
`expanding
`utilizes a pair of slipping
`embodiment
`sleeves, each
`being a section of membrane
`folded over onto itself,
`which can either hold a self-expanding
`stent in the de- 20
`livery configuration or form a watertight chamber for
`an enclosed holding means. When the slipping sleeves
`are used to form a watertight chamber, the stent is held
`in the delivery configuration by means of a tubular
`sleeve made of water soluble material; a plurality of 25
`bands made of water soluble material, swelling band(s)
`or other degradable material. A related embodiment
`can utilize only a single slipping sleeve in a non-medial
`release form.
`An alternate embodiment of the stent delivery device 30
`lumens, each containing a teflon or
`includes separate
`hydrophilic coated wire extending
`to respective proxi-
`mal and distal movable sleeves. The physician can indi-
`vidually control each sleeve by pulling on the wire
`connected to the proximal sleeve and/or pushing on the 35
`wire connected to the distal sleeve.
`In another embodiment of the stent delivery device,
`the separate
`lumens each contain proximal and distal
`pistons which are connected by teflon or hydrophilic
`coated wires extending to their respective proximal and 40
`distal sleeves. The lumens are connected by a fluid
`communication port, which is positioned such that the
`distal piston must move distally a predetermined
`dis-
`tance before the fluid can access the port and flow into
`the proximal piston lumen, where it moves the proximal 45
`piston proximally. This causes a form of medial release
`in which the distal sleeve releases the distal end of the
`stent prior to release of the proximal end.
`This continuation-in-part
`also discloses
`application
`another embodiment called the single layer sheath stent 50
`delivery apparatus and method, which is an improve-
`ment of applicant's co-pending
`improved stent delivery
`filed Oct. 22, 1993 as
`apparatus and method application,
`Ser. No. 08/141, 269. The entire contents of Ser. No.
`08/141, 269 filed Oct. 22, 1993 are hereby incorporated
`by reference.
`The inventive
`single layer sheath stent delivery de-
`vice embodiment
`includes a catheter with a stent held in
`a reduced delivery configuration
`for insertion and trans-
`port through a body lumen to a predetermined
`site for 60
`deployment of a stent, self-expanding
`stent, stent graft
`or the like. The preferred embodiment utilizes a slipping
`sleeve, which is a section of membrane folded over onto
`itself, with a single layer sheath attached to the slipping
`sleeve which can hold a self-expanding
`in the 65
`stent
`delivery configuration. Fluid is inserted
`into the slip-
`ping sleeve through a fluid access port, and the pressure
`causes the slip seal end of the slipping sleeve to move
`
`55
`
`axially away from the stent, retracting
`the single layer
`sheath attached to the slipping sleeve, thereby releasing
`the stent to self-expand. The invention will also deliver
`non self-expanding
`stents by placing the stent around an
`expandable balloon. Once the single
`layer sheath
`is
`retracted,
`to expand the stent.
`the balloon is expanded
`An alternate embodiment of the single layer sheath
`stent delivery device provides medial release by using
`two single layer sheaths to retain the stent in the deliv-
`each being attached
`ery configuration,
`to a slipping
`sleeve. Fluid pressure causes both slipping sleeves to
`move axially away from the stent, retracting
`their re-
`spective sections of single layer sheath
`to release the
`stent for self-expansion or balloon expansion.
`BRIEF DESCRIPTION OF THE DRAWINGS
`A detailed description of the invention
`is hereafter
`described with specific reference being made
`to the
`in which:
`drawings
`FIG. 1 is a side elevational
`section showing a stent
`device with
`the slipping
`deployment
`sleeves shown
`with the stent in the uncovered position, and with the
`stent held in a confined or reduced delivery configura-
`tion with a plurality of water soluble bands;
`FIG. 2 is a side elevational section fragment of FIG.
`2 showing the slipping sleeves of FIG. 1 in the covered
`position;
`FIGS. 2A and 2B are a fragment of FIG. 2 showing
`alternate embodiment of the slipping sleeve inflation of
`FIG. 2;
`FIG. 3 is a side elevational section of the distal end
`portion of a deployment device showing
`the slipping
`sleeves of FIG. 2 retracted and with the middle bands
`dissolved;
`FIG. 4 is a showing similar to FIG. 3 illustrating a
`first alternate embodiment of the water soluble bands of
`the invention;
`FIG. 5 is a showing similar to FIG. 3 illustrating a
`second alternate embodiment of the water soluble bands
`of the invention;
`FIG. 6 is a side elevational section showing another
`embodiment of a stent delivery device according to the
`invention;
`FIG. 7 is a side elevational section showing yet an-
`other embodiment of a stent delivery device of the
`invention
`in an uncovered position;
`FIG. 8 is a side elevational section of the distal end
`portion of the invention of FIG. 7 in the covered posi-
`tion;
`FIG. 9 is a side elevational section of the distal end
`portion of the invention of FIG. 7 in mid-deployment;
`FIGS. 10A and 10B are side elevational section of the
`distal end portion of the invention showing
`the use of a
`guide catheter to retrieve a misplaced stent;
`FIG. 11 is a side elevational section of a further em-
`bodiment of a stent delivery device according
`to the
`invention;
`FIG. 12 is a side elevational section of a further em-
`bodiment of a stent delivery device utilizing pistons and
`the position of the pistons when the stent is in
`showing
`the confined position;
`FIG. 13 is a side elevational section of the embodi-
`ment of FIG. 12 showing
`the position of the pistons
`when in the deployed position;
`FIG. 14 is a side elevational section of the distal end
`portion of the embodiments of FIGS. 11 or 12, i. e. , a
`version or a piston operated version, respec-
`push/pull
`tively, the stent being in the confined position;
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 13
`
`

`

`FIG. 15 is a side elevational section of the distal end
`portion of the embodiments of FIGS. 11 or 12, the stent
`being in the deployed position;
`FIG. 16 is a side elevational section showing a single
`layer sheath alternate embodiment,
`and
`FIG. 17 is a side elevational section showing another
`embodiment of the single
`layer sheath stent delivery
`device.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`While this invention may be embodied
`in many differ-
`there are shown
`and de-
`ent forms,
`in the drawings
`scribed in detail herein specific preferred embodiments
`of the invention. The present disclosure
`is an exemplifi-
`cation of the principles of the invention and is not in-
`tended to limit the invention
`to the particular embodi-
`ments illustrated.
`FIG. 1 shows a preferred embodiment of the inven-
`tive stent delivery apparatus, generally at 10, which
`is
`used to deliver
`the stent in a reduced
`radius delivery
`to the deployment
`configuration
`site in the body. Appa-
`ratus 10 includes an elongate flexible catheter 12, which
`is extruded of a biocom-
`in the preferred embodiment
`patible and HPC (hydrophilic)
`compatible material
`such as a lubricous polyimide or polyethylene. Other
`for catheter 12 include nylons, ure-
`suitable materials
`thanes, and polypropylene materials which are compati-
`ble with silicone and/or hydrophilic coatings. It should
`be understood
`that while a hydrophilic compatible ma-
`terial is preferred, any biocompatible material may be
`used. The polyethylene
`or polypropylene, while not
`can be coated with a hydro-
`themselves hydrophilic
`philic material. Therefore, it can be seen that any HPC
`or HPC compatible material can be used to make cathe-
`ter 12. As will be discussed below, the inventive stent
`delivery apparatus allows for the outside diameter of
`the catheter to be 5. 3 French (F) (0. 070 inches or 1. 778
`mm) or less using a 0. 018 inch guidewire, which
`is a
`significant profile improvement over prior art such as
`Heyn U. S. Pat. No. 5, 201, 757 which discloses an outer
`diameter of 0. 12 inches (3. 048 mm).
`The distal end portion of catheter 12 has a pair of
`sleeves 14 and 16 which are used to form a
`slipping
`waterproof chamber around a stent 17 carried by the
`catheter. Although
`this invention will be related pri-
`to using
`the inventive delivery apparatus
`for
`marily
`delivery of self-expanding
`it should be under-
`stents,
`stood that the inventive delivery apparatus may be used
`to deliver both self-expanding
`and non self-expanding
`stents, grafts and stent grafts. Stent 17 is a self-expand-
`is a so called
`ing stent, and in the preferred embodiment
`woven braided stent of a type somewhat similar to those
`in Wallsten U. S. Pat. Nos. 4, 655, 771;
`disclosed
`4, 954, 126 and 5, 061, 275. However,
`the disclosed stent
`delivery apparatus will deliver any type of self-expand-
`ing stent, such as for example, a shape memory alloy
`stent. Stent 17 is shown confined
`in its reduced radius
`delivery configuration by a plurality of water soluble
`in FIGS. 3-6.
`bands 18, described further hereinbelow
`Two pair of radiopaque marker bands 20 and 22 are
`bonded to catheter 12 with the marker bands of pair 20
`in diameter so as to additionally be used
`being enlarged
`to aid in preventing
`stent 17 from moving axially while
`on the catheter. The use of radiographic or fluoroscopic
`to image
`the radiopaque marker
`techniques
`imaging
`bands to verify the correct positioning for stent deploy-
`in the art.
`ment is well known
`
`5
`
`25
`
`Slipping sleeves 14 and 16 are shown in FIG. 1 in the
`uncovered position. The slipping sleeves 14 and 16 are
`made of molded plastic and the preferred material
`is a
`polyolefin copolymer (POC) SURLYN TM . Other ma-
`terials such as fluoropolymers, noncompliant polyethyl-
`(PET); polyimide, nylon, polyethyl-
`ene terephthalate
`ene or the like may also be used. In the preferred em-
`bodiment, slipping sleeves 14 and 16 are molded with an
`approximately 90' knee, shown at 24, and an approxi-
`10 mately a 45 angle at 26. It has been found experimen-
`tally that the 90' knee at 24 and the 45 angle at 26 more
`easily allow the sleeve membrane material
`to roll over
`onto itself. Slipping sleeves 14 and 16 are slid over the
`catheter and bonded
`to the catheter at 28, as is well
`15 known in the art. The slipping seal 30 is formed a toler-
`the inner diameter of the seal 30 and
`ance fit between
`the outer diameter of the catheter shaft.
`Manifolds 44 and 46 are used to introduce
`fluid into
`lumens 32 and 34 respectively. Manifold 48 is used to
`20 insert a guide wire 50 through central
`lumen 52, as is
`in the art. Reference numeral 54 shows a
`well known
`section of introducer sheath through which the catheter
`into a wound and into a vessel or body lu-
`is inserted
`men.
`One advantage
`the inventive stent delivery apparatus
`is that once the catheter has reached
`the de-
`provides
`ployment site, no further movement of the catheter
`is
`required to release the stent. All movement
`required to
`release the stent is internal to the catheter. By avoiding
`30 further movement of the catheter 12, the introducer
`sheath 54 is not disturbed or moved from its body intro-
`duction
`to the entrance
`reduces
`site, which
`trauma
`wound. Also, avoiding further movement of catheter 12
`to the endothelium, which
`trauma
`minimizes
`is desir-
`35 able. By avoiding external catheter movement
`to de-
`ploy the stent 17, the inventive delivery apparatus can
`be used to deliver stents in more tortuous anatomy as
`well as allow more precise and accurate control.
`Referring now to FIG. 2, the distal end portion of
`40 catheter 12 is shown with slipping sleeves 14 and 16
`forming a waterproof chamber around stent 17. Slip-
`ping sleeves 14 and 16 are formed of a doubled-over
`section of membrane
`seals 30 of
`caused by urging
`sleeves 14 and 16 axially toward each other. This causes
`to roll over from their position as seen in
`45 the membranes
`FIG. 1 onto themselves at knees 24 as is seen in FIG. 2.
`It can be seen that sleeves 14 and 16 slightly overlap to
`form a seal. Stent 17 confined to its reduced radius by
`bands 18 and positioned between marker bands 20 in the
`50 chamber formed by sleeves 14 and 16.
`FIG. 3 shows the apparatus of FIGS. 1 and 2 in mid-
`i. e. the two center bands being dissolved.
`deployment,
`Fluid has been introduced
`through manifolds 44 and 46
`and into lumens 32 and 34 to enter sleeves 14 and 16.
`55 The chamber formed by the sealed end 28 and the slip-
`ping seal 30 of the sleeve is filled through
`inflation ports
`36 and 38 of each sleeve, respectively. As the fluid
`pressure builds in sleeves 14 and 16, fluid is forced out
`through seal 30 causing seal 30 to slid away from the
`60 stent 17 along the catheter 12, thereby retracting sleeves
`14 and 16 to expose or uncover stent 17 to body fluids.
`The water soluble bands 18 are preferably a polye-
`(PEO), but can be polyvinylpryyolidone
`thyleneoxide
`(PVP); polyvinyl
`alcohol (PVA); mannitol,
`complex
`65 carbohydrates of the like, and the composition of indi-
`vidual bands can be varied as desired. In FIG. 3, the
`the medial portion of stent 17 were
`bands surrounding
`constructed
`that
`such
`faster
`they dissolved
`the
`than
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1026 - Page 14
`
`

`

`30
`
`outer bands 18, resulting
`in the medial release shown in
`FIG. 3. This can be accomplished by varying
`the mo-
`lecular weights of the compositions, since the lower the
`the faster the band 18 will dissolve.
`molecular weight
`Varying the thickness or adding perforations
`(discussed
`below in connection with FIGS. 5 and 6) will also in-
`crease the rate of dissolution.
`FIGS. 4 and 5 show alternate embodiments of water
`soluble bands 18. In FIG. 4, the plurality of bands axi-
`ally spaced along stent 17 as shown in FIG. 2 have been &0
`replaced by a single tubular band 60. In the embodiment
`of tubular band 60 shown in FIG. 4, the band is thinner
`in the middle than at either end and will therefore dis-
`solve faster in the middle, allowing medial deployment.
`It can be understood
`that the thickness of band 60 can
`be varied as desired to allow for a controlled release of
`stent 17 in any manner desired by the physician, such as
`the stent starting from either the proximal or
`releasing
`It should
`distal end or in other sequential deployments.
`that band 60 can be of the same
`also be understood
`the composition of predeter-
`thickness, but by varying
`mined sections of the band 60, those predetermined
`sections can be dissolved at a faster rate, allowing for a
`controlled release of stent 17.
`FIG. 5 shows a tubular band 62 which has perfora-
`tions 64 throughout. Perforations 64 are more dense in
`the middle section of band 62 than at either end section,
`the middle section of band 62 to dis-
`thereby allowing
`solve faster, whether composition or thickness is varied
`or both. Again, the denseness of perforations 64 can be
`controlled
`throughout band 62 to allow for any type of
`sequential dissolution and self-expansion of stent 17, as
`desired.
`to the use of water soluble 35
`An alternate embodiment
`bands 18, 60 or 62 is to utilize a swelling band or other
`to the catheter
`degradable material which
`is attached
`12. This swelling band material can be complex carbo-
`crosslinked PVA/PVP,
`hydrates,
`cellulose,
`polye-
`acid or the like. Self-expanding
`thylene/acrylic
`stent 17 40
`is pressed into the swelling band material, which after
`curing, will hold stent 17 in its reduced radius delivery
`configuration. Retracting sleeves 14 and 16 exposes the
`to body fluids, which will ex-
`swelling band material
`pand or swell, releasing
`the stent 17 to self-expand. 45
`Because the swelling band material
`to the
`is attached
`catheter 12, it will be withdrawn
`from the body along
`with the catheter. It should be understood
`that the com-
`position of the swelling material could be varied
`to
`control the expansion of stent 17 as above.
`FIG. 6 shows another embodiment of the stent deliv-
`the sleeves 14 and 16 have been
`ery device in which
`replaced by a retractable sheath 66. Retractable sheath
`66 can be withdrawn using a wire as discussed below in
`connection with
`the push/pull
`sleeve and hydraulic
`sleeve embodiments. Retraction of sheath 66 allows
`body fluid to access and dissolve band 60. It should be
`that the variations of water soluble or swell-
`understood
`ing material described above can be used in connection
`with this embodiment.
`One of the important
`features of the inventive
`stent
`is that it allows
`delivery apparatus
`the physician
`to
`deploy the stent in a variety of ways. For example the
`stent can be medially deployed, deployed starting from
`the distal end of the stent or deployed starting from the 65
`proximal end of the stent. With medial deployment,
`either the proximal or distal end of the stent can be
`from its sleeve first or they can both be re-
`released
`
`50
`
`55
`
`60
`
`flexi-
`
`leased at the same time, which provides maximum
`bility to the physician.
`This deployment
`flexibility can be accomplished
`in
`several ways. One version shown in FIG. 1 is the use of
`separate lumens 32 and 34 for inflating slipping sleeves
`14 and 16, through
`inflation ports 36 and 38, to allow
`individual control over each sleeve 14 and 16. This is
`best seen in FIG. 2. Another version is shown best in
`FIG. 2A, where both the proximal inflation port 36 and
`the distal inflation port 38 share the same lumen, which
`allows for a decreased profile. In the shared
`lumen
`there are several ways to control
`version,
`the move-
`ment of sleeves 14 and 16. Sleeves 14 and 16 can be
`in FIG. 1, such that equal
`sized differently, as shown
`sleeve inflation will cause the distal sleeve 16 to release
`the distal end of stent 17 before the proximal end of
`stent 17 is released by the proximal sleeve 14. The tight-
`ness of seal 30 of each sleeve can be varied as well by
`the immersion
`controlling
`time and temperature
`in the
`hot water bath. Also, speed control bumps 42 or ridges
`can be formed in the catheter 12 (best shown in FIG. 3)
`to individually
`control the slipping of each sleeve 14
`and 16. The sleeve outer diameter could also be varied,
`the movement of the slipping
`which would vary
`sleeves. Of course, all of the various techniques could be
`easily combined as well by those skilled in the art.
`It should also be noted that although preferred,
`the
`water soluble bands are not required
`in the embodiment
`of FIG. 1. Sleeves 14 and 16 can optionally be used to
`contain stent 17 as disclosed in Wallsten U. S. Pat. Nos.
`4, 732, 152; 4, 848, 343 and Imbert 4, 875, 480. The same
`means used to cause sleeves 14 and 16 to retract will
`also permit the stent to self-expand as sleeves 14 and 16
`It should also be understood
`are retracted.
`the
`that
`techniques of varying
`lengths of
`various
`the sleeve
`sleeves 14 and 16, the tightness of the slipping seal 30,
`the outside diameter of sleeves 14 and 16, placement of
`speed control bumps 42 on catheter 12 and individual
`lumens for each of the sleeves 14 and 16 allow for great
`control over the movement of sleeves 14 and 16, with or
`without water soluble band(s) 18, 60 or 62.
`Referring now to FIGS. 7-10, yet another embodi-
`ment of the stent delivery device is shown in which a
`sleeve 70 is shown
`single slipping
`in the uncovered
`position (FIG. 7). The distal end of sleeve 70 is con-
`tained by cylindrical gripping means 72, which is made
`of silicone rubber,
`latex or the like, and is bonded
`to
`catheter 12 with an open end oriented toward the sleeve
`and the stent to receive them as best seen in FIG. 8. The
`stent 17 may, but n