United States Patent [191
`Damon
`
`[54] TUBULAR ENDOPROSTHESIS FOR
`ANATOMICAL CONDUI'I‘S
`[76] Inventor: Jean-Francois Dumon, Clos
`d’Albizzi, 3, avenue de la Gare,
`Cassis, France, 13260
`566,350
`[21] Appl. No.:
`Mar. 2, 1989
`[22] PCT Filed:
`PCf/FR89/00083
`[86] PCT No.:
`Aug. 23, 1990
`§ 371 Date:
`Aug. 23, 1990
`§ 102(e) Date:
`[87] PCT Pub. No.: W089/07916
`PCT Pub. Date: Sep. 8, 1989
`Foreign Application Priority Data
`[30]
`Mar. 2, 1988 [FR] France .............................. .. 88 02835
`
`[51] Int.'Cl.5 .............................................. .. A61F 2/06
`[52] US. 01. ...................................... .. 623/1; 606/151;
`623/12; 604/53; 128/830
`[58] Field 01' Search ....................... .. 623/1, 8, 12,4, 9,
`623/11, 11; 604/53, 96, 264; 128/830-834,
`842-844; 606/151
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`2,701,559 2/1955
`3,818,511 6/1974
`3,818,515 6/1974
`4,164,045 8/1979
`4,224,933 9/1980
`4,588,461 5/1986
`
`llllllIIIIIIIIlllllllllllllllllllllllllllllllllllllllllllIlllllllllllllllll
`US005236446A
`[11] Patent Number:
`5,236,446
`[45] Date of Patent:
`Aug. 17, 1993
`
`France .
`France .
`United Kingdom 1
`
`4,592,341 6/1986 Omagari et al. .
`4,699,611 10/1931 Bowden.
`4,728,328 3/1988 Hughes 6181..
`4,132,152 3/1933 Wallstén 6161. ...................... .. 623/1
`4,852,586 8/1989 Haines ......... ..
`.. 128/842
`4,863,477 9/ 1989
`Monson
`4,955,909 9/1990
`FOREIGN PATENT DOCUMENTS
`146794 7/1985
`European Pat. Off. .
`1103165 10/1955
`France .
`2122032 8/1972
`France .
`2248015 5/1975
`2391709 12/1978
`1565828 4/1980
`OTHER PUBLICATIONS
`Copy of International Search Report with annex.
`Copy of International Preliminary Examination.
`Primary Examiner-David Isabella
`Assistant Examiner-Gina M. Gualtieri
`Attorney, Agent, or Finn-Sandler Greenblum &
`Bernstein
`ABSTRACT
`[51]
`Tubular endoprosthesis for anatomical conduits is pro
`vided with a tubular body having an external surface
`which includes a plurality of protuberances. Preferably,
`the protuberances are distributed on the totality of the
`external surface, and are composed of nipples having a
`round apex, spaced from each other and radially ori
`ented with respect to the tubular body.
`
`11 Claims, 4 Drawing Sheets
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-1
`
`

`

`US. Patent
`
`Aug. 17, 1993
`
`Sheet 1 of 4
`
`5,236,446
`
`2_
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-2
`
`

`

`US. Patent
`
`Aug. 17, 1993
`
`Sheet 2 of 4
`
`5,236,446
`
`
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-3
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-3
`
`

`

`US. Patent
`
`Aug. 17, 1993
`
`-
`
`Sheet 3 0:4
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`5,236,446
`
`6 6G
`
`7
`
`LII
`a
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`B\ 5
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`W -
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`W.L. Gore & Associates, Inc.
`Exhibit 1026-4
`
`

`

`US. Patent
`
`Aug. 17, 1993
`
`Sheet 4 of 4
`
`v5,236,446
`
`fig-J2
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-5
`
`

`

`1
`
`TUBULAR ENDOPROSTHESIS FOR
`ANATOMICAL CONDUITS
`
`5,236,446
`
`2
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a perspective view of the tubular endopros
`thesis according to the invention.
`FIG. 2 is a lengthwise cross-section of the tubular
`endoprosthesis shown in FIG. 1.
`FIG. 3 is a transverse cross-section of the tubular
`endoprosthesis shown in FIG. 2.
`FIG. 4 is an enlarged view, in detail, of a lengthwise
`cross-section of one of the ends of the endoprosthesis.
`FIG. 5 is a front view of an embodiment of utilizing
`the endoprosthesis according to the invention, to permit
`tracheal bronchus clearance.
`FIG. 6 is a view of the instruments permitting the
`placement of an endoprosthesis like the one illustrated
`in FIGS. 1-4.
`FIGS. 7-11 show the operation of the placement
`instrument shown in FIG. 6 and the installation method
`for the tubular endoprosthesis according to the inven
`tion.
`FIG. 12 is a front view of another embodiment of a
`tracheal bronchus endoprosthesis according to the in
`vention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`We refer to the following embodiments to describe
`the non-limiting construction of this endoprosthesis, as
`well as the use of instruments permitting its installation.
`The tubular endoprosthesis according to the inven
`tion can, as a function of the shape of the anatomical
`conduit or channel inside which it is intended to be
`installed, affect a variety of shapes. Particular embodi
`ments have a simple rectilinear or essentially rectilinear
`shape (for example, when it is a tracheal endoprosthesis
`or bronchus endoprosthesis) as shown in FIG. 1, or a
`curved shape. Another embodiment has a more com
`plex shape with a principle tube extending into two
`divergent tubular branches (when it is a trachea bron
`chus endoprosthesis) as shown in FIG. 5. More pre
`cisely, this endoprosthesis can have any shape and any
`diameter adapted to the shape and the diameter of the
`conduits, channels or vessels inside which it is to be
`placed. The endoprosthesis can be made in any supple,
`semi-rigid, or rigid material, and may be reinforced by
`an internal reinforcement capable of being well
`tolerated by the organism. Preferred embodiments can
`be advantageously made in a material with an elastic
`deformation capacity which in a particularly preferred
`embodiments is an elastomer silicon.
`'
`-
`According to one embodiment of the invention, the
`endoprosthesis has a tubular body 1 with an external
`surface 2, which is intended to come into contact with
`the internal wall of an anatomical conduit. External
`surface 2 is provided with numerous protuberances or
`asperities 3, which may be distributed evenly over the
`entire external surface 2 or positions thereof.
`These protuberances or asperities 3 can have very
`different shapes, without edges that could injure the
`anatomical walls with which they are supposed to come
`into contact. In a preferred embodiment the proterber~
`ances or asperities 3 consist of nipples with rounded
`tops, arranged in lines oriented according to the rulings
`of the endoprosthesis; these lines of nipples can be angu
`larly spaced, as shown particularly in FIG. 1. .These
`nipples 3 are radially-oriented in relation to the tubular
`body 1, and they are spaced from each other in the
`lengthwise direction as well as the peripheral direction.
`
`5
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention concerns a tubular endopros
`thesis for anatomical conduits or channels. Speci?cally,
`particular nonlimiting embodiments of this endopros
`thesis are intended to permit the clearance of hardened
`conduits such as the trachea or bronchus, or to serve as
`a support for such anatomical conduits when they
`prove to be weak. Also described is an instrument to put
`this endoprosthesis in place.
`2. Description of Background and Relevant Informa
`tion
`A hollow tube is disclosed in French Patent Docu
`ment No. 1,130,165 for the treatment of hardening of
`20
`the esophagus. The device constitutes a ?exible tube
`with a ribbed external surface intended to be installed in
`a tumoral contraction to permit the passage of food.
`This hollow tube has the drawback of not offering
`any guarantee that it will stay in place, because it can
`25
`easily turn on itself, which can provoke irritation. Such
`irritation generates rejection spasms leading to axial
`shift of the tube, along with the serious consequences to
`which this shift can lead.
`
`15
`
`30
`
`SUMMARY OF THE INVENTION
`One of the objects of the present invention is to effec
`tively remedy this serious insufficiency of known endo
`prostheses.
`35
`According to the invention, this objective is obtained
`by means of an endoprosthesis with a tubular body
`whose external surface is provided with numerous pro
`tuberances or asperities, preferably distributed over the
`entire surface, or a portion thereof. These protuber
`ances consists of nipples with rounded tops, which are
`spaced from each other in the longitudinal and periph
`eral directions on the tubular body, and are preferably
`radially-oriented.
`Another advantage of the endoprosthesis according
`to the invention is that it can be put easily in place and
`installs itself in a natural, extremely resistant fashion. In
`its implantation position, the prosthesis cannot, in effect,
`turn or slide axially when it is installed in the stenosis. In
`addition, this prosthesis may be made of a plastic mate
`rial, such as an elastomer silicone, which is well toler»
`ated by the organism whether healthy or ill, in whom it
`does not produce rejection spasms or trauma.
`In another embodiment of the tubular endoprosthesis
`according to the invention, the nipples are arranged in
`lines with spaces in between them and are oriented
`along the rulings of the tubular body of the endopros
`thesis.
`The nipples can also be alternatingly distributed on
`the external surface of the tubular body.
`-
`In another embodiment of the tubular endoprosthesis
`according to the invention, at least one of its ends has an
`internal slanted wall. Optionally, both or all of its ends
`may have an internal slanted wall.
`The goals, characteristics, and advantages above, and
`others, will be more apparent from the following de
`scription and the attached Figures.
`
`45
`
`50
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`55
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`65
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-6
`
`

`

`15
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`30
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`35
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`25
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`5,236,446
`3
`4
`They can be advantageously distributed alternately on
`FIGS. 7-11 show the installation procedure of a sim
`ple endoprosthesis 8 in an anatomical conduit B (for,
`the lateral surface of the tubular body 1. The nipples can
`example, trachea or bronchus) obstructed by a compres
`have a circular or any other shaped section. Also, these
`sive tumor S.
`nipples or nibs 3 are ineffaceable, that is, they are suffi
`The endoprosthesis 8 is ?rst placed around the end of
`ciently rigid so that they don’t compress, bend, or re
`the rod 6a of the bronchoscope 6, in front of the pusher
`tract under the conditions of use.
`7 (FIG. 7), the tapered end of the rod emerging at the
`At least one, and preferably both ends, of the endo
`front of the endoprosthesis, in order to facilitate its
`prosthesis are provided with an internal sloping edge 4
`progress in the anatomical conduit.
`(FIG. 4), so that the ends consist of thin, tapered lips.
`The rod furnished with endoprosthesis 8 is then intro
`This feature provides that when the endoprosthesis is in
`duced and driven into the anatomical conduit B (FIG.
`place, it forms no retention asperity favoring the forma
`8) until said endoprosthesis reaches the desired position
`tion of diverse accumulations as a function of the nature
`(FIG. 9), that is, the place where the hardening or com
`of the conduits, channels or vessels, at the entry or exit
`pressive tumor is located.
`of the prosthesis.
`The rod 60 of the bronchoscope is then withdrawn
`The alternative embodiment of the prosthesis illus
`while maintaining the pusher 7 in place, which prevents
`trated in FIG. 5 differs from the preceding only by its
`any backwards movement of the endoprosthesis during
`slightly more complex shape adapted to the conforma
`this withdrawal (FIG. 10). Finally, the pusher is with
`tion of the conduits in which it is to be installed. Ac
`drawn, the endoprosthesis then being installed and sol
`cording to this variation of construction, the prosthesis
`idly ?xed in its lodging because of the nipples provided
`20
`includes a principal tubular body 1’ extended by two
`on its external surface, on which the surrounding ana
`divergent tubular branches 1"; the external surfaces 2’,
`tomical wall exerts pressure preventing any shift or
`2" of the main body and of the branches are provided
`movement of the endoprosthesis.
`with nipples 3, as previously described. Such a prosthe
`I claim:
`sis is intended to be placed at the branching point of an
`1. Tubular endoprosthesis for anatomical conduits,
`anatomical conduit. According to a very interesting
`comprising:
`application, such a prosthesis is intended to constitute a
`a biocompatible tubular body composed of a semi
`tracheobronchus endoprosthesis, allowing the conduit
`rigid or rigid material having an external surface
`to remain open despite an obstruction S affecting both
`and two open ends forming a passage there
`the internal part of the trachea T and the initial portion
`through, said body adapted to contact an internal
`of the two bronchi B to be bypassed.
`wall of the anatomical conduit; and
`FIG. 12 shows another embodiment of a prosthesis
`means forming a plurality of discrete protuberances
`according to the invention such as a tracheobronchus
`distributed on said external surface for maintaining
`endoprosthesis, also intended to be placed at the
`said tubular body within said anatomical conduit
`branching point of an anatomical conduit, such as in the
`against return or axial displacement without injur
`case of an obstruction S to be by-passed affecting only
`ing the internal wall of the anatomical conduit; and
`the base of the major conduit (trachea T, for example)
`said means forming a plurality of protuberances com
`and only one of the branches (one of the bronchi B’, for
`prising ineffaceable nipples having rounded tops,
`example). In this case, the prosthesis has a curved shape
`with said nipples being spaced along the length and
`and includes a major part 10 extended by a second part
`periphery of said external surface of said tubular
`40
`of smaller diameter 10'. In addition, it has an opening 9
`body.
`laterally placed at the juncture point of the major part
`2. The tubular endoprosthesis according to claim 1,
`10 and secondary part 10', the opening 9 is intended to
`wherein said nipples are radially oriented with respect
`be placed at the entry of a second healthy branch of an
`to said tubular body.
`anatomical conduit (the other bronchus B", for exam
`3. The tubular endoprosthesis according to claim 1,
`ple), in order to permit a passage between the principal
`wherein said nipples having rounded tops are distrib
`conduit T and a healthy branch B".
`uted over substantially the entire external surface of said
`The lateral opening 9 can also allow and favor the
`tubular body.
`installation of a second independent tubular branch
`4. The tubular endoprosthesis according to claim 1,
`similar to the secondary part 10', in order to create an
`wherein said nipples are arranged in lines which are
`endoprosthesis like the one shown in FIG. 5.
`spaced from each other along said length of the external
`We have shown in FIG. 6 an installation or introduc
`surface.
`tion instrument for endoprosthesis consisting of a recti
`5. The tubular endoprosthesis according to claim 4,
`linear or essentially rectilinear tube such as those which
`wherein said lines are positioned along rulings of said
`are intended to be installed in the trachea or in the
`tubular body.
`weak, hardened or tumor-compressed bronchi, in order
`6. The tubular endoprosthesis according to claim 5,
`to serve as their support or to permit them to be cleared.
`wherein said nipples are alternately distributed along
`This instrument includes a classic bronchoscope 6 on
`said tubular body.
`the elongated cylindrical body or guidance rod 60, on
`7. The tubular endoprosthesis according to claim 1,
`which is mounted, with a sliding ability in relation to
`wherein said semi-rigid or rigid material comprises a
`60
`said rod, a tubular pusher 7 whose length L’ is less ‘than
`material having elastic deformation ability.
`the length L of the guidance rod 60. The difference in
`8. The tubular endoprosthesis according to claim 7,
`length between the rod 60 of the bronchoscope and the
`wherein said material is an elastomeric silicone.
`pusher 7 corresponds at least to the length L" of the
`9. The tubular endoprosthesis according to claim 1,
`endoprosthesis 8 intended to be introduced and posi
`wherein said tubular body includes a lateral opening
`tioned with the help of the instrument; this difference in
`adapted to maintain a passage between an anatomical
`length (L-L') being, however, preferably greater than
`conduit in which the tubular endoprosthesis is posi
`the length L’ of the endoprosthesis.
`tioned and a branch thereof.
`
`45
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`50
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`55
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`65
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`W.L. Gore & Associates, Inc.
`Exhibit 1026-7
`
`

`

`‘5,236,446
`
`5
`10. Tubular endoprosthesis for anatomical conduits, '
`comprising:
`a biocompatible tubular body having an external sur-
`facc, wherein 881d tubular body includes two open 5
`ends, and at least one of said two ends has an inter-
`"31 slants? W311; and _
`_
`'
`m?ans formlng a Plufahty of P1” ombel'ances dlsmb'
`uted on said external surface for maintaining said
`tubular body in an anatomical conduit without 10
`
`6
`injPI‘ing anatomical Walls Of the anatomical @011
`‘dull; and
`_
`.
`said means forming a Plurahty of protuberances com‘
`prising nipples having rounded tops, with said nip
`pics being Spaced along the length and periphery of
`said enema] surface of said tubular body
`11. The tubular endoprosthesis according to claim 10,
`wherein each of said two ends has an internal slanted
`wall,
`
`' * ‘ F *
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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
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`45
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`50
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`55
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`65
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`W.L. Gore & Associates, Inc.
`Exhibit 1026-8
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE‘ OF CORRECTION
`
`PATENTNO. : 5,236,446
`DATED
`; August 17, 1993
`~INVENTOR(S) I J. DUMON
`
`It is certified that error appearsin the above-indenti?ed patent and that said Letters Patent is hereby
`corrected as shown below:
`1
`
`At column ‘1. line 40 of the printed patent, change "consists" 'to -——
`consist---.
`At column 4, line 35' (claim 1, line 11) of the printed patent,
`change "return" to ---turning--—.
`
`‘ Signed and Sealed this
`'Fi?eenth Day of November, 1994'
`
`Am‘
`
`mg 0m‘!!!
`
`Commissioner of Parent: and Trademark:
`
`BRUCE LEMAN
`
`W.L. Gore & Associates, Inc.
`Exhibit 1026-9
`
`