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`—401—
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 1
`
`

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`—402—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 2
`
`

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`—403—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 3
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 3
`
`

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`—404—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 4
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 4
`
`

`

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`—405—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 5
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 5
`
`

`

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`—406—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 6
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 6
`
`

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`—407—-—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 7
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 7
`
`

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`—408—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 8
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 8
`
`

`

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`—409—
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 9
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 9
`
`

`

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`—410—-
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 10
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 10
`
`

`

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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 11
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 11
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`

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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 12
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 12
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 13
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 13
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 14
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 14
`
`

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`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 15
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 15
`
`

`

`(19) Japan Patent Office (JP)
`
`(12) Publication of Unexamined Patent Application (A)
`
`(11) Publication Number: H4-64367 (1992-64367)
`
`(43) Publication Date: February 28, 1992
`Int. Cl.5
`Identification
`(51)
`
`A 61 M 29/02
`
`A 61 B 17/00
`320
`A 61 M 25/00
`
`
`Ref. No.
`8718-4C
`8932-4C
`
`8718-4C
`
`
`
`(54) [Title of the Invention]: Expansion tool for biological ducts
`
`
`
`
`
` A
`
` 61 M 25/00 410F
`Request for Examination: Not requested
`Number of Claims: 1 (Total 15 pages)
`
`(21) Application Number:
`(22) Date of Filing:
`
`(72) Inventor:
`Isami Hirao
`
`c/o Olympus Optical Co., Ltd., 2-43-2 Hatagaya, Shibuya-ku, Tokyo, Japan
`
`1990-174377
`July 3, 1990
`
`(72) Inventor: Kazuhiko Ozeki
`
`c/o Olympus Optical Co., Ltd., 2-43-2 Hatagaya, Shibuya-ku, Tokyo, Japan
`
`(72) Inventor: Ryoichi Kono
`
`c/o Olympus Optical Co., Ltd., 2-43-2 Hatagaya, Shibuya-ku, Tokyo, Japan
`
`(71) Applicant: Olympus Optical Co., Ltd.
`
`2-43-2 Hatagaya, Shibuya-ku, Tokyo, Japan
`
`(74) Agent:
`
`Atsushi Tsuboi, patent attorney (two others)
`
`
`
`Detailed Description
`
`1. Title of the Invention: Expansion tool for biological ducts
`2. Scope of Claims:
`
`The expansion tool for biological ducts, as contained in this invention, being characterized by
`
`comprising protective materials on at least a portion of the exterior surface of the expansion tool that is
`mounted on a balloon dilator in order to prevent the expansion tool from damaging the tissues, as in the
`case of the expansion tool for biological ducts, and by the fact that this device is attached to the balloon
`dilator for the purpose of insertion into the narrowed section of the biological duct in vivo and being left
`in the narrowed section of the biological duct in vivo following expansion by the balloon dilator.
`
`3. Detailed Description of the Invention
`[Field of Industrial Application]
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 16
`
`

`

`This invention pertains to an expansion tool for biological ducts, being used to expand the
`
`narrowed sections of biological ducts, such as blood vessels, the esophagus, bile ducts, pancreatic ducts,
`urethra and ureter, and is left in the biological duct so as to maintain the lumen in the open state.
`
`[Prior Art]
`
`Known examples of this type of expansion tool for biological ducts are described in literature
`
`such as the patent publications S62-231657 and S63-214264. These are used to treat the narrowed
`sections of blood vessels or the enlarged prostates. The stent with multiple holes is configured as a mesh
`or a pipe, and is attached to the balloon dilator. The balloon dilator is expanded after the stent is inserted
`within the blood vessel or urethra. The stent is simultaneously expanded together with the balloon dilator.
`The balloon dilator is pulled out after the stent is expanded, and only the stent is left within the biological
`duct so as to maintain the lumen of blood vessels or urethra in the open state.
`
`[Problems to Be Resolved by the Invention]
`
`In the above traditional expansion tools for biological ducts, however, both edges of the stent are
`very hard and sharp. This is because the mesh-type stent uses wire elements such as stainless steel or
`titanium, and the pipe-shaped stent with multiple holes formed on is configured as a hard member such as
`stainless pipe.
`
`(P.2)
`
`Therefore, there is a risk that the edges of these types of stent may rip the in-vivo tissues or may
`
`create holes in the in-vivo tissues, when the stent is inserted into the biological duct such as blood vessels,
`bile ducts or urethra, or when the stent is left within the biological duct.
`
`Additionally, when the stent is used to treat the stenosis of the bile duct, for example, the stent is
`inserted through the channel of the endoscope. In this situation, problems may be encountered such as the
`internal surface of the channel of the endoscope is damaged by the hard and sharp edges of the stent, or
`the edge of the stent is caught at the edge of the forceps raiser of the endoscope making it difficult to feed
`the stent through the inner diameter of the endoscope.
`
`This invention is conceived by carefully considering the aforementioned problems. The purpose
`
`of this invention is to provide the expansion tool for biological ducts having relatively simple
`configuration that would not damage the in-vivo tissues or the endoscope when being inserted into the
`biological duct or when being left within the biological duct.
`
`[Means of Solving the Problems]
`
`To solve aforementioned problems for the expansion tool for biological ducts that is attached to
`
`the balloon dilator when being inserted into a biological duct and is left within a biological duct following
`expansion by the balloon dilator, this invention provides the protective materials on at least a portion of
`the exterior surface of the expansion tool attached to the balloon dilator in order to prevent damage to in-
`vivo tissues from the expansion tool.
`
`Thus, by having the protective materials on the balloon dilator, the aforementioned protective
`material1 would prevent damaging in-vivo tissues when inserting the expansion tool into a biological duct,
`or it would prevent damaging internal surface of the channel of the endoscope when the expansion tool is
`inserted through the channel of the endoscope.
`
`1 [Translator’s note] Amendment 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1015 - Page 17
`
`

`

`[Embodiment]
`
`
`
`The figures 1 through 5 show the first embodiment of this invention.
`
`The stent 1 in Figure 1 is configured into a tube shape by weaving wire materials, such as
`
`stainless steel or titanium. At both ends 2, the contact points or intersections of wires are spot welded or
`fastened by adhesives that are biologically compatible.
`
`Additionally, Figure 2 shows the overall configuration of the expansion tool containing the stent
`1. The balloon