`
`COUNTY OF NEW YORK
`
`ss
`
`CERTIFICATION
`
`This is to certify that the attached translation is, to the best of my knowledge and belief, a true
`
`and accurate translation from Japanese into English of the attached Japan Patent Application
`
`Public Disclosure No.: 858-46923.
`
`Robert Adler, Project Manager
`Geotext Translations, Inc.
`
`Sworn to and subscribed before me
`this-2-dayof JUne ,20~.
`
`EVAN FINCH
`NOTARY PUBLIC-STATE OF NEW YORK
`No. 0 lFI6134600
`Qualified In New Yorl< County
`My Commission Expires October 03, 2009
`
`New York 259 West 30th Street, 17th Floor. New York. NY 10001. U.S.A. 1:eI212.631.7432 fax 212.631.7778
`San Francisco 220 Montgomery Street. 3rd Floor. San Francisco. CA 94104. U.SA. teI415.576.9500 fax 415.520.0525
`London 107-111 Fleet Street. London EC4A 2AB, United Kin9dom tel +44.(0)20.7936.9002 fax +44.(0)20.7990.9909
`Hong Kong 20th Floor. Central Tower. 28 Dueen's Road. Canual. Hong Kong tel +852.2159.9143 fax +852.3010.0082
`translations@geotext.com I www.geotext.com
`
`Edwards Exhibit 1006, p. 1
`
`
`
`(19) Japan Patent Office (JP)
`(12) Publication ofUnexarnlned Patent Application (A)
`
`(11) Japan Patent Application Public Disclosure No.:
`858-46923
`
`(5]) Int. Cl.l
`
`IDSymbo\
`
`A61B 1/00
`17/28
`
`Intra-Agency
`FileNo.
`7916-4C
`7058-4C
`
`(43) Disclosure Date:
`March 18, 1983
`
`Number of inventions: I
`Request for examination: Not requested
`(Total pages: 5)
`
`(54) Title ofthe invention:
`(21) Application no.:
`(22) Application date:
`(72) Inventor:
`
`(72) Inventor:
`
`Endoscope
`S56-144326
`September 12, 1981
`Aldo Miyauchi
`c/o Fuji Photo Film Co., Ltd.
`3-11-46, Senzui, Asaka City
`Masarnichi Sato
`c/o Fuji Photo Film Co., Ltd.
`3-11-46, Senzui, Asaka City
`
`(72) Inventor:
`
`(71) Applicant:
`
`(71) Applicant:
`
`(74) Agent:
`
`Osarnu Arakawa
`c/o Fuji Photo Optical Co., Ltd.
`1-324, Uetake-cho, Omiya City
`Fuji Photo Film Co., Ltd.
`210, Nalcanuma, Minami-Ashigara
`City
`Fuji Photo Optical Co., Ltd.
`1-324, Uetake-cho, Omiya City
`Takao Katori, Patent Attorney
`
`SPECIFICATION
`
`1. Title of the Invention
`Endoscope
`
`2. Claims
`1. An endoscope characterized in that
`[it] contains a path that guides to the other end a
`manipulation tool inserted at one end and a heating means
`that is provided in the vicinity of the other end of the said
`path and that heats the manipulation tool,
`the manipulation tool contains a shape-memory alloy that
`memorizes a first shape adapted to the use state, and
`the aforementioned heating meana heats the manipulation
`tool, which was transformed to a second shape different
`from the first shape, to at least the reverse-n:ansformation
`temperature of the said shape-memory alloy, to restore the
`first shape.
`2. An endoscope characterized in that, in the
`endoscope described in Claim I, the aforementioned shape(cid:173)
`memory alloy is such that the reverse-transformation
`temperature is virtually equal to the temperature ofthe
`body in which the aforementioned manipUlation tool is
`used, and the aforementioned heating means heats the said
`manipUlation tool to at least the body temperature.
`3. An endoscope characterized in that, in the
`endoscope described in Claim I, the
`
`aforementioned path contains a cooling means that
`maintains the manipulation tool inserted into the said path
`at or below the reverse-transformation temperature ofthe
`shape-memory alloy of the said manipulation tool.
`
`3. Detailed Explanation of the Invention
`The present invention relates to an endoscope, and
`particularly [relates] to an endoscope equipped with a
`manipulation tool, such as forceps, a treatment tool, etc.
`Conventionally, in the observation and treatment of a
`body cavity or internal organ by means of an endoscope,
`the usual (procedure] is to insert a manipulation tool (e.g.,
`forceps, treatment tool) via a forceps hole penctrated by the
`endoscope, excise tissue from the body cavity or internal
`organ, and perform treatment. These variously shaped
`forceps and treatment tools include the biopsy forceps,
`basket forceps, high-frequency snare, three-nail forceps,
`alligator forceps, coagulation electrode, washing tube,
`cytology brush, etc. However, certain shapes and sizes are
`required for the respective applications. Furthermore, these
`forceps and treatment tools are hereinafter collectively
`called "manipulation tools."
`
`-97-
`
`Edwards Exhibit 1006, p. 2
`
`
`
`(2)
`
`Japan Patent Application Public Disclosure
`No. S58-46923
`
`On the one hand, however. to minimize pain experienced
`by a patient as well as the insertion resistance when
`inserting an endoscope into the living body and particularly
`the body cavity of the patient, there is demand for
`minimizing the outside diameters ofthe endoscope head
`and junctions. Consequently, the diameter of the forceps
`hole into which a manipulation tool is inserted and guided
`into a body cavity also preferably is small.
`An endoscope equipped with a conventional
`manipulation tool cannot simultaneously satisfY these
`conflicting requirements, so some degree of compromise
`has been required. For example, a basket forceps, etc., is
`inserted into a forceps hole by deforming within the elastic
`limit of its material, so the insertion resistance is high. Also,
`in a side-view endoscope, in order to stand these
`manipulation tools in the usable state, [they] are oriented
`almost vertically relative to the lengthwise direction of the
`endoscope, so they are equipped at their head with a
`forceps standing table operated by means of a wire from the
`operating portion. The provision of such a movable portion
`at the endoscope head increases the size of the head and
`junctions, thereby reducing the reliability ofthe
`mechanically operated device.
`
`be set such that the manipulation tool is heated to at least
`the body temperature
`The path that guides the manipulation tool also may be
`equipped with a cooling means that maintains the
`manipUlation tool inserted therein at or below the reverse(cid:173)
`transformation temperature ofthe shape-memory alloy.
`Next, an embodiment of the endoscope based on the
`present invention will be explained in detail, with reference
`to the appended drawings. Furthermore, in the present
`spBcifica1ion, the endoscope includes not only those used in
`a living body, but also industrial [endoscopes) used within
`the internal cavities of devices, etc.
`Figure 1, a partially cutaway side-view ofthe
`cndoscope based on the present invention, shows the part of
`the endoscope inserted into a body cavity (i.e., its head).
`This head has a cylindrical sheath 10 composed of a plastic
`or a plastic-coated metal, and at the end thereof is provided
`a forceps hole 14 that performs suction or through which is
`passed a manipulation tool 12 (e.g., the basket forceps
`shown in the drawing or other forceps or a treatment tool).
`The forceps hole 14 is connected to a tube-shaped path 16
`that guides the manipulation tool 12, and a heating means
`
`Japan Palent Application Public Disclosure No. 858-46923 (2)
`
`The present invention eliminates such conventional
`. technical drawbacks, and aims at providing an endoscope
`that subjects the patient to little pain during insertion.
`Another purpose of the present invention is to provide
`an endoscope with high reliability that is capable of
`extracting or inserting, without resistance, the manipulation
`tool with the required shape and size in the use state.
`According to the present invention, these purposes are
`achieved by an endoscope such as the following. That is,
`this endoscope contains a path that guides to the other end a
`manipUlation tool inserted at one end and a heating means
`that is provided in the vicinity ofthe other end of the said
`path and that heats the manipulation tool; this manipulation
`tool contains a shape-memory alloy that memorizes a first
`shape adapted to the use state; and a heating means heats
`the manipulation tool, which was transformed to a second
`shape different from the first shape, to at least the reverse(cid:173)
`transformation temperature of the shape-memory alloy, to
`restore the first shape.
`The shape-memory alloy of the manipulation tool may
`be set such that ihe reverse-transformation temperature
`becomes virtually equal to the body temperature at which
`the manipulation tool is used, and the heating means may.
`
`18 is provided in a shape that surrounds the periphery of
`the path 16, at the junction between the forceps hole 14 and
`the path 16 ofthe sheath 10.
`The heating means 18 is a resistance heating element
`composed of a carbon fixed resistor, a wire-wound resistor,
`etc., shaped so as to surround the periphery of the tube(cid:173)
`shaped path 16, and it is connected via a lead wire 20 to an
`external power supply (not shown). Within the sheath 10
`arc provided the additional mechanisms required by the
`endoscope; for example, an objective lens 22 and an image
`bundle 24 composed of optical fiber. To simplifY the
`drawings, other mechanisms (e.g., the light guide, air line,
`water line) have been omitted from the drawings.
`As is commonly known, the basket forceps 12
`captures and removes from the body calculi within body
`cavities, for example. In the use state, the form shown in
`the drawings is adopted. According to the present invention,
`the basket forceps 12 are composed of a so-called Kshape(cid:173)
`memory aHoy."
`As is commonly known, a "shape-memory alloy" is an
`alloy that, when heated to at least a certain temperature (i.e.,
`
`-98-
`
`Edwards Exhibit 1006, p. 3
`
`
`
`(3)
`
`Japan Patent Application Public Disclosure
`No. 858-46923
`
`the reverse-transformation temperature), loses existing
`plastic deformation-induced strain. More specifically, the
`crystal structure of the high-temperature phase called the
`mother phase or the beta phase is formed by heating to at
`least the transformation temperature a shape-memory alloy
`formed into a certain shape. Next, when this is rapidly
`cooled to or below the transformation temperature, the
`martensitic crystal structure results. Suppose that, however,
`stress is applied to the alloy in this state, thereby deforming
`[the alloy1 into a shape different from the original shape.
`The strain resulting from this deformation is maintained,
`but ifthis is heated to or above the reverse-transformation
`temperature, this strain is eliminated and the original shape
`is restored. It is said that this is because the martensitic
`structure reverse-transforms to the mother phase.
`The manipulation tool 12, such as a basket forceps, of
`the endoscope of the present invention is composed of this
`shape-memory alloy. To explain the basket forceps 12
`shown in Figure I, for example, [it] is shaped into the
`shape shown in Figure I, and it is heated to at least Its
`transformation temperature and then rapidly cooled. To
`insert such forceps 12 into the-tube-shaped path 16 via the
`forceps insertion hole (not shown) of the operation portion
`of the endoscope and guide [it] smoothly into the forceps
`hole 14 of
`
`means 18 because considerable response time might be
`required to restore the manipUlation tool 12 to its original
`shape by means of natural heating by body temperature. By
`using the heating means 18, it is possible to set a high
`reverse-transformation temperature for restoring the
`manipulation tool 12 to its original shape. This increases
`the range (i.e., freedom) in selecting the composition of the
`shape-memory alloy ofthe manipulation tool 12. However,
`it is preferable to avoid inflicting lesions or pain in a living
`body as a result of the increased temperature caused by the
`heating means, when the endoscope is used in a living body.
`For the aforemcntioned reasons, therefore, it is effective to
`heat to a temperature slightly higher than the temperature
`of the living body. In the case of Cu-A1-Zn, for example, it
`is possible to set the martensitic transformation starting
`temperature to 38°C in a composition composed of 74%
`Cu, 8% AI, and 18% Zn. So, according to the present
`invention, it normally is preferable to set such that reverse(cid:173)
`transformation occurs at a temperature between a
`temperature slightly higher than the normal temperature
`and a temperature that does not inflict a lesion or pain in a
`living body (i.e., 30-50 0c). lfthe reverse-transformation
`temperature is low, the
`
`Japan Patent Application Public Disclosure No. S5846923 (3)
`
`the head, it is preferable to insert {it] into the path 16, after
`temporarily deforming [it] into a shape long in the
`lengthwise direction, which is shown in Figure 2. The
`basket forceps 12 deformed thus is heated to at least the
`reverse-transformation temperature of this shape-memory
`alloy by passing electric current through the heating means
`18 provided near the forceps hole 14, thereby restoring [it}
`to its original shape (i.e., the shape ofthe basket forceps 12
`in the use state).
`Examples of shape-memory alloys used as the
`manipulation tool 12 include Ti-Ni, Ag-Cd, Au-Cd, Cu-AJ(cid:173)
`Ni. Cu-Al-Zn, Cu-Zn, Ni-AI, etc. However, Ti-Ni, Cu-Al(cid:173)
`Zn, etc., are particularly useful.
`In the case of an endoscope inserted into a body cavity,
`it is preferable to set the reverse-transformation
`temperature near this body temperature, after appropriately
`selecting the composition of the shape-memory alloy ofthe
`manipulation tool 12. It is preferable to use a heating
`
`manipulation tool 12 is cooled in advance, and during use it
`is immediately inserted into the tube-shaped path 16, via
`the forceps insertion hole (not shown) of the endoscope
`operation portion. It also is possible to configure the
`endoscope so as to maintain the manipulation too112 at or
`below the reverse-transformation temperature of this shape(cid:173)
`memory alloy, by cooling the surroundings of the tube(cid:173)
`shaped path 16 with a water line, etc.
`Such a shape-memory alloy also has so-called
`"pseudo elasticity" or "superelasticity." so the endoscope of
`the present invention is advantageous, also, when
`extracting in the original direction a manipulation tool 12
`that returned to its original shape, via the tube-shaped path
`16, after insertion. "PseudoeJasticity" or "superelasticity"
`indicates a property such that, even if stress is applied in
`excess of the normal elastic limit, strain occurs as ifit were
`subjected to plastic deformation, but when the stress is
`eliminated, the original shape is restored, so there is no
`residual permanent strain. Therefore, in the endoscope of
`Figurc I, It basket forceps 12 that uses such a shapc(cid:173)
`memory alloy returns to the shape of the usable state, and
`after a calculus, etc., is captured within a body cavity, [it] is
`removed smoothly from the forceps insertion hole (not
`shown) ofthe endoscope operation portion, in the direction
`opposite to insertion into the path 16. Such a manipulation
`tool 12 withstands repeated use any number oftimes, so it
`has a long life.
`
`-99-
`
`Edwards Exhibit 1006, p. 4
`
`
`
`(4)
`
`Japan Patent Application Public Disclosure
`No. S5&-46923
`
`In addition to basket forceps, forceps for scraping out
`calculi, which are shaped as shown in Figures 3(A), (B),
`and (C), exist as such a manipulation tool 12. All ofthese
`are formed of a Ti-Ni or another shape-memory alloy, for
`example, and the shapes of the use states shown in the
`figures are memorized. When [it] is inserted into an
`endoscope, it is deformed into a linear shape, such as that
`shown in Figure 4. In this manner, it is possible to rapidly
`and smoothly insert [it] into the path 16, and near the
`opening 14 [it] is heated by the heating means 18, thereby
`restoring its original shape (Le., the shape shown in Figure
`3), resulting in the usable state.
`Another embodiment of the endoscope of the present
`invention is shown in Figure 5. Unlike the straight-view
`endoscope, this is an example of a side-view endoscope
`shown in Figure 1. The structural elements identical to
`those shown in Figure 1 are labeled identically. The head of
`this endoscope is partitioned into two chambers by a
`partition 30. The right side of the partition 30 in the same
`figure is completely waterproof, and it houses, for example,
`
`after which [it] exits to the exterior via the rectangular
`opening 44. The neck portion 46 of the biopsy forceps 32
`shown as an example is composed of a coil-shaped shape(cid:173)
`memory alloy or a linear or tube-shaped shape-memory
`alloy, as shown in the figure, and the use state shape, such
`as that shown in the figure, is memorized. That is, it is
`formed into a shape like that in the figure, heated to at least
`the transformation temperature, and cooled rapidly. If
`necessary, it is cooled, and as in the case shown in Figure 4,
`it is formed into a linear shape. Then it is inserted into the
`tube-shaped path 16 via the forceps insertion hole of the
`endoscope operation portion, after which it is heated to at
`least the reverse-transformation temperature by means of
`the heating means 18, thereby restoring the original shape
`shown in the figure, which results in the usable state.
`In the embodiment shown in Figure 5, the mechanisms
`required in a conventional endoscope (e.g., the forceps
`standing table required for standing in the usable state the
`standing-type forceps, the wire that operates this, etc.) are
`not required. Therefore, the size of the endoscope itself
`shrinks and the mechanical operation portions become
`fewer, so device reliability also improves.
`
`Japan Patent Application Public Disclosure No. S58-46923 (4)
`
`a tube-shaped path 16 that guides the manipulation tool 32
`(e.g., biopsy forceps) shown as an example, as well as the
`objective lens 22, mirror or prism 34, imaging lens 36, and
`image bundle 24 composed of optical fiber. In addition, a
`light guide 38 is shown as an example ofa mechanism
`required in the endoscope, and as shown in the figure, this
`passes through the partition 30 and extends to the window
`40 at the top of the left chamber. At the left cnd of the tube(cid:173)
`shaped path 16, an opening 42 is fonned in the partition 30,
`and as shown in the figure a heating element 18 is provided.
`This may be the same as [that of) the embodiment shown in
`Figure 1. An opening 44 is formed in the side oftbe head
`sheath 10 (i.e., at the top in Figure 5), and this forms a
`rectangle that is long in the lengthwise direction ofthe
`endoscope, when viewed from above the figure. Other
`mechanisms required by an endoscope are omitted from the
`drawings for the sake of drawing simplicity.
`In the use state, a treatment tool 32 or self-standing
`forceps (e.g., the biopsy forceps in the figure) or a
`cannulation tube passes through the opening 42 at the left
`end of the tube-shaped path 16 and curves upward,
`
`By configuring as aforementioned the endoscope of
`the present invention. it is possible to smoothly insert and
`extract a manipulation tool with the shape and size
`necessary in the use state. Consequently, it is possible to
`narrow the diameter of the endoscope relatively to the size
`and shape required by the manipulation tool, so it is
`possible to reduce the pain inflicted on a patient. Also, even
`when a self-standing manipulation tool is used in a side(cid:173)
`view endoscope, it is possible to configure so as to
`minimize the mechanical, movable parts, which improves
`device reliability.
`4. Brief Explanation of the Drawings
`Figure 1 is a partially cross-sectional side view
`showing an embodiment of the endoscope of the present
`invention.
`Figures 2-4 are diagrams showing the shape of the
`manipulation tool used in the endoscope of the present
`invention.
`Figure 5 is a partially cross-sectional view showing
`another embodiment of the endoscope of the present
`invention.
`Explanation of Symbols for Main Components
`]6 Tube-shaped path
`12 Manipulation tool
`18 Heating means
`
`-100-
`
`Edwards Exhibit 1006, p. 5
`
`
`
`(5)
`
`Japan Patent Application Public Disclosure
`No. 858-46923
`
`Japan Patent Application Public Disclosure No. S5846923 (5)
`
`Patent applicants:
`
`Agent
`
`Fuji Photo Film Co., Ltd.
`Fuji Photo Optical Co., Ltd.
`Takao Katori, Patent Attorney (seal:] Katori
`
`Figure 1
`
`Pigure3
`
`(Al
`
`(el
`
`Figure 5
`
`Figure 4
`
`Figure 2
`;:.;JF2!j
`
`"3
`
`-101-
`
`Edwards Exhibit 1006, p. 6
`
`
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`Edwards Exhibit 1006, p. 7
`
`
`
`4?fmJIIB58-46923
`
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