BSC USP 8,142,413
`Exhibit 1040
`
`Page 1 of 9
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0236215 A1
`(43) Pub. Date:
`Nov. 25, 2004
`Mihara et al.
`
`US 20040236215A1
`
`CATHETER
`
`Publication Classi?cation
`
`Inventors: Nobuaki Mihara, Shizuoka (JP);
`Makoto Muto, Saitarna (JP)
`
`(51) Int. Cl? ..................................................... .. A61B 6/00
`(52) Us. 01. ......................... .. 600/434; 604/528; 604/529
`
`(54)
`(75)
`
`(73)
`
`(21)
`(22)
`(30)
`
`Correspondence Address:
`BURNS DOANE SWECKER & MATHIS L L P
`POST OFFICE BOX 1404
`ALEXANDRIA, VA 22313-1404 (US)
`
`Assignee: TERUMO KABUSHIKI KAISHA,
`Shibuya-ku (JP)
`
`Appl. No.:
`
`10/798,400
`
`Filed:
`
`Mar. 12, 2004
`
`Foreign Application Priority Data
`
`Mar. 14, 2003
`
`(JP) .................................... .. 2003-070808
`
`(57)
`
`ABSTRACT
`
`Disclosed is a catheter for penetrating a stenotic lesion
`occurred in a lumen in a human body, including:
`
`a linear Wire; and
`
`a tubular body placed on a distal end side of the Wire
`and allowing a guide Wire to be inserted through its
`holloW portion.
`
`The catheter of the present invention is excellent in push-in
`property, capable of easily and rapidly penetrating a stenotic
`lesion, and capable of being exchanged With a balloon
`catheter easily and rapidly.
`
`33
`
`3s 34 35
`
`as
`
`35
`
`1 I
`
`

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`Page 2 of 9
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`Patent Application Publication Nov. 25, 2004 Sheet 1 0f 3
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`US 2004/0236215 A1
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`

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`Page 3 of 9
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`Patent Application Publication Nov. 25, 2004 Sheet 2 0f 3
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`US 2004/0236215 A1
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`Page 4 of 9
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`Patent Application Publication Nov. 25, 2004 Sheet 3 0f 3
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`US 2004/0236215 A1
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`

`
`Page 5 of 9
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`US 2004/0236215 A1
`
`Nov. 25, 2004
`
`CATHETER
`
`BACKGROUND OF THE INVENTION
`
`[0001] 1. Field of the Invention
`
`[0002] The present invention relates to a catheter for
`penetrating a stenotic lesion or an occluded lesion occurred
`formed in a lumen in the human body.
`
`[0003] 2. Related Background Art
`
`[0004] For example, in the case Where stenosis or occlu
`sion is occurred in a lumen in the human body, such as a
`blood vessel, a bile duct, a trachea, an esophagus, or an
`urethra, a treatment for opening the stenosis or occlusion to
`recover the functions of these organs is required. Angio
`plasty applied to an ischemic heart disease Will be described
`as an example of such a treatment.
`
`[0005] OWing to the rapid increase in number of patients
`of ischemic heart diseases (angina pectoris, myocardial
`infarct, etc.) due to WesterniZation of dietary habits in Japan,
`percutaneous transluminal coronary angioplasty (PTCA) is
`performed as a method for alleviating such diseases and is
`rapidly spreading. The PTCA is the folloWing procedure. A
`small incision is formed in an artery of a leg or an arm of a
`patient, and an introducer sheath (introduction unit) is
`placed therein. While a guide Wire is alloWed to travel ?rst
`through a lumen of the introducer sheath, a long holloW tube
`called a guide catheter is inserted in a blood vessel, and
`placed at an entrance of a coronary artery. After that, the
`guide Wire is pulled out, and another guide Wire and a
`balloon catheter are inserted in a lumen of the guide catheter.
`While the guide Wire is alloWed to travel ?rst, the balloon
`catheter is alloWed to proceed to a lesion (stenotic lesion part
`or occluded lesion) of the coronary artery of the patient by
`visualiZation With an X-ray. A balloon is positioned in the
`lesion. A doctor in?ates the balloon at that position once or
`a plurality of times at a predetermined pressure for about 30
`to 60 seconds. As a result, the lumen of the blood vessel in
`the lesion is opened, Whereby the amount of blood ?oWing
`through the lumen of the blood vessel increases.
`
`[0006] HoWever, in the case Where the stenosis of a lesion
`is tight, and the lesion is substantially occluded, a balloon
`catheter may not be able to pass through the lesion.
`
`[0007] Thus, a catheter (for penetrating a coronary artery)
`for previously penetrating a lesion before inserting a balloon
`catheter has been developed (e.g., see JP 2002-301161 A).
`This catheter has a tubular body having a guide Wire lumen
`and a port provided on a proximal end side of the tubular
`body, and is con?gured so as to insert a guide Wire in the
`guide Wire lumen from the port.
`
`[0008] HoWever, according to the catheter described in JP
`2002-301161 A, the guide Wire lumen is formed over the
`entire length of the catheter. Therefore, to exchange the
`catheter With a balloon catheter With the guide Wire placed
`in the blood vessel, it is required that the length of the guide
`Wire be set to be tWice or more the entire length of the
`catheter. When the catheter is pulled out from the blood
`vessel, it is required that the catheter be operated along such
`a long guide Wire as described above. The requirement
`results in poor operability When the catheter is exchanged
`With the balloon catheter.
`
`[0009] Furthermore, the catheter described in JP 2002
`301161 A is composed of a holloW tubular member over the
`entire length, so that the catheter is highly soft (?exible) over
`the entire length. Therefore, a push-in force applied from a
`hand side (port) is dif?cult to be transmitted, and the catheter
`may have dif?culty in penetrating stenotic lesion.
`
`SUMMARY OF THE INVENTION
`
`[0010] An object of the present invention is to provide a
`catheter excellent in push-in property, capable of easily and
`rapidly penetrating a stenotic lesion, and capable of being
`exchanged With a balloon catheter easily and rapidly.
`[0011] The above-mentioned object is achieved by the
`folloWing (1) to (10).
`[0012] (1) A catheter for penetrating a stenotic lesion
`occurred in a lumen in a human body, including:
`[0013]
`[0014] a tubular body placed on a distal end side of
`the Wire and alloWing a guide Wire to be inserted
`through its holloW portion.
`
`a linear Wire; and
`
`[0015] (2) The catheter according to the above (1), in
`Which the Wire has a metal Wire and a covering layer
`composed of a resin material covering an outside of the
`metal Wire.
`[0016] (3) The catheter according to the above (1) or (2),
`in Which the Wire has a surface layer composed of a
`hydrophilic material covering an outer surface of the Wire.
`
`[0017] (4) The catheter according to any one of the above
`(1) to (3), in Which the tubular body includes a plurality of
`markers each having a visualiZation property arranged in a
`longitudinal direction.
`[0018] (5) The catheter according to any one of the above
`(1) to (4), in Which the tubular body has an inner layer
`positioned on an inner circumferential side, an outer layer
`formed on an outer circumferential side of the inner layer,
`and a reinforcing body placed betWeen the inner layer and
`the outer layer.
`
`[0019] (6) The catheter according to any one of the above
`(1) to (5), further including an operation portion placed on
`a proximal end side of the Wire.
`[0020] (7) The catheter according to the above (6), in
`Which the operation portion can be adjusted and ?xed for its
`position With respect to the Wire.
`[0021] (8) The catheter according to the above (6), in
`Which the operation portion is adhered to the Wire.
`
`[0022] (9) The catheter according to any one of the above
`(1) to (8), in Which the tubular body is placed With its center
`decentered With respect to a center of the Wire.
`
`[0023] (10) The catheter according to any one of the above
`(1) to (9), in Which the Wire is connected to the tubular body
`under a condition that a distal end portion of the Wire
`partially overlaps With a proximal end portion of the tubular
`body.
`[0024] As described beloW, the catheter of the present
`invention has an excellent push-in property. Therefore, a
`push-in force applied from a proximal end side is transmit
`ted to a distal end portion exactly, and as a result, the catheter
`can penetrate a stenotic lesion occurred in a lumen in the
`human body easily and rapidly.
`
`

`
`Page 6 of 9
`
`US 2004/0236215 A1
`
`Nov. 25, 2004
`
`[0025] Furthermore, the catheter of the present invention
`can be exchanged With a balloon catheter even if the length
`of a guide Wire is short. Therefore, the catheter of the present
`invention can be exchanged With the balloon catheter easily
`and rapidly.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the accompanying draWings:
`[0026]
`[0027] FIG. 1 is an entire front vieW shoWing an embodi
`ment of a catheter of the present invention;
`[0028] FIG. 2 is a vertical cross-sectional vieW shoWing
`an enlarged portion on a distal end side of the catheter shoWn
`in FIG. 1; and
`
`[0029] FIG. 3 is a schematic plan vieW of an evaluation
`system for evaluating the catheter of the present invention
`for push-in property.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`[0030] Hereinafter, a catheter of the present invention Will
`be described in detail by Way of preferable embodiments
`With reference to the attached draWings.
`
`[0031] FIG. 1 is an entire front vieW shoWing an embodi
`ment of a catheter of the present invention. FIG. 2 is a
`vertical cross-sectional vieW shoWing an enlarged portion on
`a distal end side of the catheter shoWn in FIG. 1. In the
`folloWing description, the left side in each of FIGS. 1 and
`2 refers to a “distal end”, and the right side in each of FIGS.
`1 and 2 refers to a “proximal end”.
`
`[0032] A catheter 1 (catheter for penetrating a stenotic
`lesion) shoWn in FIGS. 1 and 2 is a catheter for penetrating
`a stenotic lesion or an occluded lesion (hereinafter, the
`stenotic lesion and the occluded lesion Will be merely
`referred to as a “stenotic lesion” collectively) occurred in a
`lumen in the human body, such as a blood vessel, a bile duct,
`a trachea, an esophagus, or an urethra (hereinafter, referred
`to as a “blood vessel” as a representative).
`
`[0033] As shoWn in FIGS. 1 and 2, the catheter 1 includes
`a linear Wire 2, a tubular body 3 placed on a distal end side
`of the Wire 2 and alloWing a guide Wire (not shoWn) to be
`inserted in (to penetrate) its holloW portion (lumen) 31, and
`an operation portion (holding portion) 4 placed on a proxi
`mal end portion of the Wire 2.
`[0034] The entire length of the catheter 1 is not particu
`larly limited, but preferably in the range of 900 to 1700 mm,
`and more preferably in the range of 1100 to 1500 mm.
`
`[0035] When a treatment for opening a stenotic lesion by
`using a balloon catheter (not shoWn) is performed, in the
`case Where it is dif?cult for a balloon portion of the balloon
`catheter to pass through (penetrate) the stenotic lesion oWing
`to the tight stenosis, the catheter 1 is used for facilitating the
`passage. More speci?cally, prior to the use of the balloon
`catheter, the catheter 1 is inserted along a guide Wire (not
`shoWn) placed in a blood vessel. A push-in force is applied
`to the catheter 1 so as to alloW a distal end portion (tubular
`body 3) thereof to penetrate the stenotic lesion. After that,
`While the guide Wire is placed in the blood vessel, the
`catheter 1 is pulled out from the blood vessel and exchanged
`With the balloon catheter. The balloon catheter is inserted
`along the guide Wire, and a push-in force is applied thereto,
`Whereby the balloon portion is alloWed to pass through
`(penetrate) the stenotic lesion. By using the catheter 1 in this
`
`manner, the tubular body 3 of the catheter 1 has penetrated
`the stenotic lesion once. Therefore, the balloon catheter can
`be alloWed to pass through the stenotic lesion easily there
`after.
`[0036] As shoWn in FIG. 2, in the catheter 1, the holloW
`portion 31, functioning as a guide Wire lumen through Which
`a guide Wire is inserted, is formed merely in a portion of the
`tubular body 3 positioned on a distal end side, and in a
`portion of the Wire 2 positioned on a proximal end side With
`respect to the portion of the tubular body 3, no guide Wire
`lumen is formed. This con?guration provides the folloWing
`tWo advantages.
`[0037] The ?rst advantage resides in that the distal end
`portion (tubular body 3) of the catheter 1 can penetrate (pass
`through) a stenotic lesion easily and rapidly. The reason for
`this is as folloWs. The portion of the Wire 2 is solid, so that
`the Wire 2 has relatively high ?exural rigidity and torsional
`rigidity. Therefore, the push-in force applied by an operator
`from the proximal end side of the catheter 1 is transmitted
`to the distal end portion of the catheter 1 (tubular body 3)
`exactly by the Wire 2. More speci?cally, the catheter 1
`includes the Wire 2 and is thus excellent in push-in property
`(performance in Which a push-in force by an operator can be
`transmitted exactly from the proximal end side (operation
`portion 4) to the distal end side of the catheter 1). Thus, the
`distal end portion (tubular portion 3) of the catheter 1 can be
`alloWed to penetrate (pass through) the stenotic lesion easily
`and rapidly.
`[0038] In contrast, unlike the present invention, in the case
`of a catheter for penetrating a stenotic lesion in Which the
`guide Wire lumen is formed so as to extend over the entire
`length, the catheter is formed of a holloW tubular member
`over the entire length. Therefore, such a catheter lacks
`?exural rigidity and torsional rigidity. Consequently, a suf
`?cient push-in property is not obtained, Which is likely to
`cause inconvenience that the catheter cannot penetrate the
`stenotic lesion easily.
`[0039] The second advantage of the catheter 1 of the
`present invention is that an exchange operation (manipula
`tion) for exchanging With a balloon catheter can be per
`formed easily and rapidly. The reason for this is as folloWs.
`For pulling out the catheter 1 from a blood vessel, and
`exchanging it With a balloon catheter, the length of a portion
`exposed outside the human body of a guide Wire placed in
`the blood vessel only needs to be the length of the tubular
`body 3. Thus, in the case of using the catheter 1, it is possible
`to use a guide Wire With a relatively short length. Therefore,
`the catheter 1 and the balloon catheter can be pulled out or
`inserted along the guide Wire easily and rapidly. More
`speci?cally, in the catheter 1, an exchange operation for
`exchanging With the balloon catheter can be performed
`easily and rapidly.
`[0040] In contrast, unlike the present invention, in the case
`of a catheter for penetrating a stenotic lesion in Which the
`guide Wire lumen is formed so as to extend over the entire
`length, for exchanging With the balloon catheter, the length
`of a portion exposed outside the human body of a guide Wire
`placed in the blood vessel needs to be at least the entire
`length of the catheter for penetrating a stenotic lesion. More
`speci?cally, the entire length of the guide Wire needs to be
`very long, i.e., at least tWice the entire length of the catheter
`for penetrating a stenotic lesion, and the catheter must be
`exchanged With the balloon catheter along this long guide
`Wire. Thus, it is cumbersome to exchange the catheter With
`the balloon catheter, and great amounts of time and labor are
`required.
`
`

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`Page 7 of 9
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`US 2004/0236215 A1
`
`Nov. 25, 2004
`
`[0041] Hereinafter, the con?guration of each portion of the
`catheter 1 Will be described.
`
`[0042] As shoWn in FIG. 2, the Wire 2 has a metal Wire 21
`and a covering layer 22 composed of a resin material,
`covering the outside of the metal Wire 21.
`
`[0043] Although a metal material constituting the metal
`Wire 21 is not particularly limited, it is preferable that the
`metal Wire 21 be made of stainless steel (SUS), an Ni—Ti
`alloy, a cobalt alloy, a connected body thereof (e.g., a
`coupled (connected) body in Which an SUS Wire is coupled
`(connected) With an Ni—Ti alloy Wire in the middle in a
`longitudinal direction), or the like. According to this con
`?guration, the Wire 2 is provided With appropriate rigidity
`(?exural rigidity and torsional rigidity), Which enhances a
`push-in property and transmittance of a torque. Conse
`quently, the catheter 1 can penetrate a stenotic lesion more
`easily.
`[0044] Although the resin material constituting the cover
`ing layer 22 is not particularly limited, it is preferable that
`the covering layer 22 be formed of, for example, various
`kinds of thermoplastic elastomers such as a polyurethane
`elastomer, a polyester elastomer, and a polyamide elastomer,
`or a mixture thereof. Of those, a polyurethane elastomer is
`more preferable. In the case Where the covering layer 22 is
`formed of a polyurethane elastomer, there is an advantage in
`that the covering layer 22 is particularly excellent in thermal
`processability.
`[0045] Furthermore, the covering layer 22 may contain,
`for example, an X-ray non-transparent material (x-ray visu
`aliZation agent) such as tungsten.
`
`[0046] It is preferable that a surface layer composed of a
`hydrophilic material (hydrophilic polymer) be provided on
`an outer surface (outer surface of the covering layer 22) of
`the Wire 2. According to this con?guration, the catheter 1 can
`be inserted more smoothly and more easily. Although the
`hydrophilic material is not particularly limited, examples of
`the hydrophilic material include a copolymer of methyl
`vinyl ether and maleic anhydride and a copolymer of dim
`ethylacrylamide and glycidyl methacrylate.
`
`[0047] According to one preferable aspect, the Wire 2 is
`composed of: a long proximal portion extending from its
`proximal end portion and having a substantially constant
`outer diameter; and a distal portion connected to the distal
`end side of the proximal portion With its outer diameter
`decreasing continuously toWard the distal end.
`
`[0048] The outer diameter of the Wire 2 in the proximal
`portion is not particularly limited. Although a preferable
`value of the outer diameter varies depending upon the
`constituent material and the purpose of use, generally, the
`outer diameter is preferably 0.5 to 1.5 mm, and more
`preferably 0.8 to 1.1 mm. Furthermore, the length of the
`distal portion is preferably 30 to 150 mm, and more pref
`erably 50 to 100 mm. Furthermore, the outer diameter of the
`distal end of the Wire 2 is preferably 0.4 to 1.4 mm, and more
`preferably 0.7 to 1.0 mm.
`
`[0049] The tubular body 3 is provided on the distal end
`side of the Wire 2. The holloW portion 31 of the tubular body
`3 is opened to the distal end and the proximal end of the
`tubular body 3, Whereby a guide Wire can be inserted
`(penetrate) in the holloW portion 31.
`
`[0050] The tubular body 3 has an inner layer 32 positioned
`on an inner circumferential side, an outer layer 33 formed on
`an outer circumferential side of the inner layer 32, and a
`reinforcing body (reinforcing member) 34 placed betWeen
`the inner layer 32 and the outer layer 33.
`[0051] Although the constituent material for the inner
`layer 32 is not particularly limited, for example, the inner
`layer 32 is preferably formed of a ?uorine resin such as
`polytetra?uoroethylene (PTFE). According to this con?gu
`ration, the friction coef?cient of the inner circumferential
`surface of the inner layer 32 becomes small. Therefore, the
`sliding resistance betWeen the inner circumferential surface
`of the inner layer 32 and the guide Wire decreases, Whereby
`the guide Wire can be inserted more smoothly.
`
`[0052] Although the constituent material for the outer
`layer 33 is not particularly limited, for example, it is
`preferable that the outer layer 33 be composed of various
`kinds of thermoplastic elastomers such as a polyurethane
`elastomer, a polyester elastomer, and a polyamide elastomer,
`or a mixture thereof. Furthermore, the outer layer 33 may be
`con?gured by combining (coupling) a plurality of tubes
`having different conditions With respect to a hardness and an
`outer diameter and the like With each other.
`
`[0053] In this embodiment, the reinforcing body 34 is a
`spiral coil composed of tungsten. The reinforcing body 34 is
`placed in such a manner that the reinforcing body 34 is
`buried in the outer layer 33 (or the inner layer 32). The
`reinforcing body 34 is not limited to a spiral coil, and may
`be a braided body (net-shaped body), a bar-shaped body, or
`the like. Its material is not limited to tungsten. The reinforc
`ing body 34 may be made of stainless steel or the like.
`
`[0054] The outer surface of the tubular body 3 is prefer
`ably provided With a surface layer composed of a hydro
`philic material (hydrophilic polymer). According to this
`con?guration, the catheter 1 can be inserted more smoothly
`and more easily. The same materials as those described
`above can be used as the hydrophilic material.
`
`[0055] Although the outer diameter of the tubular body 3
`is not particularly limited, the outer diameter is preferably
`0.5 to 1.5 mm, and more preferably 0.7 to 1.0 mm. Further
`more, the outer diameter of the tubular body 3 may vary in
`a longitudinal direction. For example, the outer diameter
`may decrease gradually toWard a distal end direction. Fur
`thermore, the outer diameter of the tubular body 3 in a ?xed
`portion With the Wire 2 is preferably 0.8 to 1.5 mm, and more
`preferably 1.0 to 1.3 mm.
`
`[0056] Although the inner diameter of the tubular body 3,
`in other Words, the diameter of the holloW portion 31, is not
`particularly limited, the inner diameter is preferably 0.4 to
`0.8 mm, and more preferably 0.45 to 0.65 mm.
`[0057] Although the length of the tubular body 3 (length
`represented by L1 in FIG. 2) is not particularly limited, the
`length is preferably in the range of 100 to 400 mm, and more
`preferably 200 to 300 mm. Setting the length of the tubular
`body 3 to be Within such a range can provide excellent
`folloWingness When the catheter 1 is inserted in a blood
`vessel, Which is bent in a complicated manner, along the
`guide Wire, and can suf?ciently shorten the length of the
`guide Wire required for exchanging With the balloon cath
`eter. As a result, an exchange operation can be performed
`more easily and more rapidly.
`
`

`
`Page 8 of 9
`
`US 2004/0236215 A1
`
`Nov. 25, 2004
`
`[0058] The tubular body 3 has a plurality of markers 35
`each having an X-ray visualization property (X-ray non
`transparency). Those markers 35 are arranged at intervals in
`the longitudinal direction of the tubular body 3. With this
`arrangement, When the tubular body 3 is alloWed to pen
`etrate a stenotic lesion of the blood vessel under X-ray
`radioscopy, the markers 35 function as a scale, Whereby the
`length of the stenotic lesion can be measured (identi?ed).
`Although the set interval (pitch) of the markers 35 is not
`particularly limited, it is preferably 5 to 15 mm, and more
`preferably about 10 mm.
`
`[0059] In this embodiment, those markers 35 are con?g
`ured by closely Winding the reinforcing body 34 composed
`of a spiral coil at several portions. This makes it unnecessary
`to provide another member as the markers 35, so that the
`catheter 1 can be produced easily, and the tubular body 3 can
`have a decreased diameter.
`
`[0060] The markers 35 each have an X-ray visualiZation
`property under X-ray radioscopy oWing to X-ray non
`transparency. Such markers 35 usually have visualiZation
`properties even in CT scanning, MRI, and the like, so that
`they can be used even in CT scanning, MRI, and the like.
`
`[0061] The tubular body 3 and the Wire 2 are coupled
`(?xed) under a condition that the distal end portion of the
`Wire 2 and the proximal end portion of the tubular body 3
`partially overlap With each other in a longitudinal direction.
`With this con?guration, the Wire 2 and the tubular body 3
`overlap With each other in the coupled portion (?xed por
`tion). Therefore, high coupling strength can be obtained, and
`the enlargement of the distal end portion of the catheter 1 can
`be prevented.
`
`[0062] Although a method for ?xing the Wire 2 and the
`tubular body 3 is not particularly limited, they are ?xed by
`covering the outside (outer circumference) of the overlapped
`portion betWeen the Wire 2 and the tubular body 3 With a
`reinforcing tube (coupling member) 5 in this embodiment.
`In particular, in the case Where the covering layer 22 of the
`Wire 2, the outer layer 33 of the tubular body 3, and the
`reinforcing tube 5 are made of the same or similar material
`(e.g., a polyurethane elastomer), the overlapped portion
`betWeen the Wire 2 and the tubular body 3 is covered With
`the reinforcing tube 5, and thereafter, they are fused,
`Whereby the Wire 2 and the tubular body 3 can be ?xed more
`strongly in an easy process.
`[0063] Although the length (length represented by L2 in
`FIG. 2) of the overlapped portion betWeen the Wire 2 and the
`tubular body 3 is not particularly limited, it is preferably 1
`to 100 mm, and more preferably 5 to 60 mm.
`
`[0064] The tubular body 3 is provided With its center
`decentered With respect to the center of the Wire 2. With this
`con?guration, the holloW portion 31 can be kept Wide and
`straight in the vicinity of the ?xed portion betWeen the
`tubular body 3 and the Wire 2. Therefore, the guide Wire can
`be inserted more smoothly.
`
`[0065] The operation portion 4 is provided at the proximal
`end portion of the Wire 2. An operator grabs the operation
`portion 4, thereby more easily operating (pushing, tWisting,
`etc.) the catheter 1.
`
`[0066] The operation portion 4 may be ?xed to the proxi
`mal end portion of the Wire 2. Alternatively, the operation
`portion 4 may be adjusted and ?xed for its position at an
`arbitrary position With respect to the Wire 2 in a longitudinal
`
`direction. This con?guration alloWs the operation portion 4
`to be adjusted to be an easy-to-handle position. Any con
`?guration for enabling the operation portion 4 to be ?xed at
`an arbitrary position of the Wire 2 may be used. Examples of
`the con?guration include a con?guration similar to an opera
`tion holding member of a guide Wire described in JP
`5-29543 U.
`
`[0067] The embodiment of the catheter according to the
`present invention shoWn in FIGS. 1 and 2 has been
`described above. HoWever, the present invention is not
`limited thereto. Each portion constituting the catheter can be
`replaced by an arbitrary con?guration capable of exhibiting
`the similar function. Furthermore, an arbitrary component
`may be added.
`[0068] This application claims priority on Japanese patent
`application No.2003-70808, the contents of Which are
`hereby incorporated by reference. In addition, the contents
`of literatures cited herein are incorporated by reference.
`
`EXAMPLES
`
`[0069] Hereinafter, the present invention Will be described
`speci?cally by Way of examples. It should be noted that the
`present invention is not limited thereto.
`
`Example 1
`
`[0070] To evaluate the catheter of the present invention for
`push-in property, an evaluation system Was produced. FIG.
`3 is a schematic plan vieW shoWing the evaluation system for
`evaluating the catheter of the present invention for push-in
`property. The evaluation system 10 shoWn in FIG. 3 is
`composed of the catheter 1 of the present invention, a
`guiding catheter 6, a guide Wire 7, and a load detecting
`portion 8 having a torque device 81 and a load sensor 82. In
`FIG. 3, for convenience of the description, the catheter 1 is
`shoWn With the thickness thereof and the like enlarged.
`
`[0071] The catheter 1 of the present invention used for
`evaluation Was the same as that shoWn in FIGS. 1 and 2
`(provided that the distal end side of the Wire 2 Was tapered
`in this example). The siZe and material of each portion are
`as folloWs.
`[0072] <SiZe>
`[0073] Length of the Wire 2: 1060 mm
`[0074] Length of L2: 10 mm
`[0075] Length of L1: 250 mm
`[0076] Outer diameter of the covering layer 22 of a portion
`betWeen 0 and 980 mm from the proximal end side of the
`Wire 2: 0.92 mm
`
`[0077] Outer diameter of the metal Wire 21 of a portion
`betWeen 0 and 980 mm from the proximal end side of the
`Wire 2: 0.60 mm
`
`[0078] Outer diameter of the covering layer 22 of a portion
`betWeen 980 and 1050 mm from the proximal end side of the
`Wire 2: tapered from 0.92 mm (980 mm from the proximal
`end side) to 0.82 mm (1050 mm from the proximal end side)
`[0079] Outer diameter of the metal Wire 21 of a portion
`betWeen 980 and 1050 mm from the proximal end side of the
`Wire 2: tapered from 0.60 mm (980 mm from the proximal
`end side) to 0.35 mm (1050 mm from the proximal end side)
`
`

`
`Page 9 of 9
`
`US 2004/0236215 A1
`
`Nov. 25, 2004
`
`[0080] Outer diameter of a portion (corresponding to L2)
`between 1050 and 1060 mm from the proximal end side of
`the Wire 2: 1.21 mm
`
`[0081] Outer diameter of a portion betWeen 0 and 90 mm
`from the proximal end side of the tubular body 3: 0.87 mm
`
`[0082] Outer diameter of a portion betWeen 90 and 250
`mm from the proximal end side of the tubular body 3: 0.83
`mm Inner diameter of the tubular body 3: 0.56 mm
`
`[0083] <Material>
`[0084] Metal Wire 21: Ni—Ti
`[0085] Covering layer 22: polyurethane elastomer con
`taining 45 Wt % of tungsten
`
`[0086] Inner layer 32: PTFE
`
`[0087] Portion betWeen 0 and 90 mm from the proximal
`end side of the outer layer 33: polyurethane elastomer
`
`[0088] Portion betWeen 90 and 250 mm from the proximal
`end side of the outer layer 33: polyester elastomer
`[0089] Reinforcing body 34: spiral coil composed of tung
`sten
`
`[0090] Reinforcing tube 5: polyurethane elastomer
`
`[0091] Provided on an outer circumferential surface of a
`portion betWeen 0 and 780 mm from the distal end side of
`the catheter 1 is a hydrophilic coating of a dimethylacryla
`mide-glycidyl methacrylate copolymer.
`[0092] First, the guiding catheter 6 (Heart Rail 6, produced
`by Terumo Corp.; having an inner diameter of 1.8 mm and
`a length of 100 cm) primed With distilled Water Was bent in
`a shape as shoWn in FIG. 3 to produce a blood vessel model.
`The distal end of the guiding catheter 6 Was placed at a
`position that Was assumed to be engaged With an entrance of
`the coronary artery.
`
`[0093] Then, the guide Wire 7 (Cross Wire Ex 7, produced
`by Terumo Corp.: outer diameter: 0.36 mm; length: 180 cm)
`Was inserted in the tubular body 3 of the above-described
`catheter 1. After that, the catheter 1 Was inserted in the
`guiding catheter 6 together With the guide Wire 7.
`
`[0094] Furthermore, the load detecting portion 8 Was set
`so that the guide Wire 7 Was inserted through the torque
`device 81 and the distal end of the tubular body 3 of the
`catheter 1 came into contact With the end of the torque
`device 81. Then, the guide Wire 7 Was ?xed on a proximal
`end side.
`
`[0095] The catheter 1 Was guided With a guide tube (inner
`diameter: 2 mm) (not shoWn) betWeen the distal end of the
`guiding catheter 6 and the torque device 81. The guide tube
`Was provided so as not to come into contact With the torque
`device 81.
`
`[0096] After that, the operation portion 4 of the catheter 1
`Was pushed in at a distance of 10 mm or 15 mm. The load
`(striking resistance) detected by the load sensor 82 of the
`load detecting portion 8 Was measured through the distal end
`of the tubular body 3 and the torque device 81.
`
`Comparative Example 1
`[0098] The striking resistance Was measured in the same
`Way as in Example 1 except for using a catheter (NAVI
`CATH produced by Terumo Corp.) With a guide Wire lumen
`formed over the entire length of the catheter in place of the
`catheter 1 of the present invention.
`
`[0099] Table 1 shoWs the results.
`
`TABLE 1
`
`Striking
`Resistance gf
`
`10 mm
`
`15 mm
`
`23
`15
`
`22
`14
`
`Example 1
`Comparative
`Example 1
`
`[0100] As shoWn in Table 1, it Was con?rmed that the
`catheter of the present invention (Example 1) has a high
`striking resistance and an excellent push-in property, com
`pared With the catheter With the guide Wire lumen formed
`over the entire length of the catheter (Comparative
`Example).
`What is claimed is:
`1. A catheter for penetrating a stenotic lesion occurred in
`a lumen in a human body, including:
`
`a linear Wire; and
`a tubular body placed on a distal end side of the Wire and
`alloWing a guide Wire to be inserted through its holloW
`portion.
`2. The catheter according to claim 1, in Which the Wire has
`a metal Wire and a covering layer composed of a resin
`material covering an outside of the metal Wire.
`3. The catheter according to claim 1, in Which the Wire has
`a surface layer composed of a hydrophilic material covering
`an outer surface of the Wire.
`4. The catheter according to claim 1, in Which the tubular
`body includes a plurality of markers each having a visual
`iZation property arranged in a longitudinal direction.
`5. The catheter according to claim 1, in Which th