(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
`
`(54) CATHETER
`(75) Inventors: Nobuaki Mihara, Shizuoka (JP);
`Makoto Muto, Saitama (JP)
`Correspondence Address:
`BURNS DOANE SWECKER & MATHIS LLP
`POST OFFICE BOX 1404
`ALEXANDRIA, VA 22313-1404 (US)
`(73) Assignee: TERUMO KABUSHIKI KAISHA,
`Shibuya-ku (JP)
`(21) Appl. No.:
`10/798,400
`(22) Filed:
`Mar. 12, 2004
`(30)
`Foreign Application Priority Data
`
`Mar. 14, 2003 (JP)...................................... 2003-070808
`
`Publication Classification
`
`(51) Int. Cl." ....................................................... A61B 6100
`(52) U.S. Cl. ........................... 600/434; 604/528; 604/529
`
`(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
`
`35 34 35
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`35
`
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`
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`Page 1
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`Medtronic Exhibit 1033
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`Patent Application Publication Nov. 25, 2004 Sheet 1 of 3
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`US 2004/0236215 A1
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`Page 2
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`Medtronic Exhibit 1033
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`Patent Application Publication Nov. 25, 2004 Sheet 2 of 3
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`US 2004/0236215 A1
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`Z * 5)I, H
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`Page 3
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`Medtronic Exhibit 1033
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`Patent Application Publication Nov. 25, 2004 Sheet 3 of 3
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`US 2004/0236215 A1
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`s
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`Page 4
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`Medtronic Exhibit 1033
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`

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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 first
`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 first, the balloon
`catheter is allowed to proceed to a lesion (Stenoticlesion 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 inflates 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 flowing
`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 configured 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
`301.161A is composed of a hollow tubular member over the
`entire length, so that the catheter is highly soft (flexible) over
`the entire length. Therefore, a push-in force applied from a
`hand side (port) is difficult to be transmitted, and the catheter
`may have difficulty 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)
`a linear wire, and
`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.
`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 fixed 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 5
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`Medtronic Exhibit 1033
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`

`US 2004/0236215 Al
`
`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 cathetercasily
`and rapidly.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0026]
`
`In the accompanying drawings:
`
`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
`[0027] FIG.1is an entire front view showing an embodi-
`respect to the portion of the tubular body 3, no guide wire
`ment of a catheter of the present invention;
`lumenis formed. This configuration provides the following
`two advantages.
`[0037] The first 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 hasrelatively high flexural 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 specifically,
`the catheter 1
`includes the wire 2 andis thus excellent in push-in property
`[0030] Hereinafter, a catheter of the present invention will
`(performance in which a push-in force by an operator can be
`be described in detail by way of preferable embodiments
`transmitted exactly from the proximal end side (operation
`with reference to the attached drawings.
`portion 4)to the distal end side of the catheter 1). Thus,the
`
`[0031] FIG.1is an entire front view showing an embodi- distal end portion (tubular portion 3) of the catheter 1 can be
`ment of a catheter of the present invention. FIG. 2 is a
`allowed to penetrate (pass through) the stenotic lesion easily
`vertical cross-sectional view showing an enlarged portion on
`andrapidly.
`a distal end side of the catheter shown in FIG. 1. In the
`[0038]
`In contrast, unlike the present invention, in the case
`following description, the left side in each of FIGS. 1 and
`of a catheter for penetrating a stenotic lesion in which the
`2 refers to a “distal end”, and the right side in cach of FIGS.
`guide wire lumen is formed so as to extend over the entire
`1 and 2 refers to a “proximal end”.
`length, the catheter is formed of a hollow tubular member
`over the entire length. Therefore, such a catheter lacks
`flexural rigidity and torsional rigidity. Consequently, a suf-
`ficient 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
`exchangingit with a balloon catheter, the length of a portion
`exposed outside the human bodyof a guide wire placed in
`the blood vessel only needs to be the length of the tubular
`body3. Thus, in the case of using the catheter1, 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
`specifically,
`in the catheter 1, an exchange operation for
`exchanging with the balloon catheter can be performed
`easily and rapidly.
`[0040]
`Incontrast, 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 bodyof 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
`specifically, the entire length of the guide wire needs to be
`very long,Le., 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. ‘hus, it is cumbersome to exchange the catheter with
`the balloon catheter, and great amounts of time and laborare
`required.
`
`[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
`
`(0032] A catheter 1 (catheter for penetrating a stenotic
`lesion) shown in FIGS. 1 and2 is a catheter for penetrating
`a stenotic lesion or an occluded lesion (hercinaftcr,
`the
`stenotic lesion and the occluded lesion will be merely
`referred to as a “stenotic lesion” collectively) occurred in a
`lumenin the human body, suchasa bloodvessel, a bile duct,
`a trachea, an esophagus, or an urethra (hereinafter, referred
`to as a “blood vessel” as a representative).
`[0033] As shownin FIGS.1 and2, 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
`insertedin (to penetrate) ils 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 il is difficult 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 specifically, 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 applicd thereto,
`whereby the balloon portion is allowed to pass through
`(penetrate) the stenotic lesion. By using the catheter 1 in this
`
`Page 6
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`Medtronic Exhibit 1033
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`US 2004/0236215 A1
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`Nov. 25, 2004
`
`0041. Hereinafter, the configuration 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.
`0.043 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
`figuration, the wire 2 is provided with appropriate rigidity
`(flexural 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.
`0.045. 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 configuration, 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.
`0.048. 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 fluorine resin such as
`polytetrafluoroethylene (PTFE). According to this configu
`ration, the friction coefficient 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
`configured 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
`configuration, 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 fixed
`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 L 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 Sufficiently 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.
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`Page 7
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`Medtronic Exhibit 1033
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`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 (identified).
`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 config
`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
`(fixed) 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 configuration, the wire 2 and the tubular body 3
`overlap with each other in the coupled portion (fixed por
`tion). Therefore, high coupling strength can be obtained, and
`the enlargement of the distal end portion of the catheter 1 can
`be prevented.
`0.062 Although a method for fixing the wire 2 and the
`tubular body 3 is not particularly limited, they are fixed 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 fixed more
`Strongly in an easy process.
`0063 Although the length (length represented by L. 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
`configuration, the hollow portion 31 can be kept wide and
`straight in the vicinity of the fixed 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.
`0.066 The operation portion 4 may be fixed to the proxi
`mal end portion of the wire 2. Alternatively, the operation
`portion 4 may be adjusted and fixed for its position at an
`arbitrary position with respect to the wire 2 in a longitudinal
`
`direction. This configuration allows the operation portion 4
`to be adjusted to be an easy-to-handle position. Any con
`figuration for enabling the operation portion 4 to be fixed at
`an arbitrary position of the wire 2 may be used. Examples of
`the configuration include a configuration Similar to an opera
`tion holding member of a guide wire described in JP
`5-29.543 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 configuration 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
`specifically 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>
`Length of the wire 2: 1060 mm
`0073)
`Length of L: 10 mm
`0074)
`Length of L: 250 mm
`0075)
`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
`0.077
`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 8
`
`Medtronic Exhibit 1033
`
`

`

`US 2004/0236215 A1
`
`Nov. 25, 2004
`
`0080) Outer diameter of a portion (corresponding to L)
`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) <Materiald
`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
`0.091
`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 fixed on a proximal
`end Side.
`0.095 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.
`0097 Table 1 shows the results.
`
`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 confirmed 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 whi