CN102743814A - Air bag catheter - Google Patents

Abstract

The present invention provides an air bag catheter increasing the flexibility of a far position end portion, wherein inside the air bag catheter, the rigid optimization of an area provided with the air bag is realized. The air bag catheter (10) is provided with an outer side pipe (15) and an inner side pipe (16), wherein the inner side pipe (16) is arranged to extend to the position of a far position side compared with the outer side pipe (15) and provided with an air bag (13) in a manner of covering the extended area from the outer side, and the inner side pipe (16) is provided with an inner side near position pipe (32) and an inner side middle pipe with a lower rigidity than the inner side near position pipe (32). Under such conditions, the far position end portion of the inner side near position pipe (32) is arranged at a position where the boundary of a far position side cone-shaped area (13d) and the far position side support area (13e) is near the near position side and the boundary of the straight pipe area (13c) of the air bag and the far position side cone-shaped area (13d) is near the far position side in the axial direction.

Description

Balloon catheter

Technical field

The balloon catheter that uses in the importing organism such as the present invention relates to when dilation therapy is carried out in the stenosis of blood vessel or obstruction place.

Background technology

At present, in treatment of PTA (percutaneous transluminal angio plasty) or PTCA (percutaneous coronary endoluminal vascular plasty) etc., used balloon catheter.Balloon catheter possesses conduit with managing and being fixed in this conduit with the distolateral air bag of amphi position of managing.

As this balloon catheter, inpatent documentation 1 for example, for improve the distolateral flexibility of amphi position, disclose traverse from the amphi position end towards the prescribed limit of proximal side and be provided with softish before the formation of dististyle.One of the formation example is somebody's turn to do in expression among Fig. 7.

As shown in Figure 7,balloon catheter 80 possesses conduit withpipe 81 and air bag 82.Conduit usespipe 81 to possessoutboard tube 83 and theinside tube 84 that the inner chamber that connects thisoutboard tube 83 is provided with, and insidetube 84 is set to extend to more by the amphi position side than outboard tube 83.And, be provided withair bag 82 with mode from the zone of this prolongation of outer side covers.

Air bag 82 forms with internal diameter and the multistage alternative mode of external diameter under swelling state.In detail,air bag 82 begins from the proximal lateral to have successively: the proximalside stent area 82a that engages withoutboard tube 83, with the mode of carrying out hole enlargement towards the distolateral internal diameter of amphi position and external diameter form cone shape proximal sideconical region 82b, at whole length direction internal diameter and external diameter is identical and the regional 82e of amphi position side stand that forms thestraight tube zone 82c in the maximum outside diameter zone ofair bag 82, form cone shape amphi position sideconical region 82d, engage withinside tube 84 with the mode of carrying out undergauge towards the distolateral internal diameter of amphi position and external diameter.

In above-mentioned formation, from the amphi position end ofinside tube 84 towards the zone of the prescribed limit of proximal side by than constituting with respect to thiszone dististyle 86 before the successive parent tube ofproximal side 85 is moresoftish.Dististyle 86 is the joint object place of the amphi positionside stand zone 82e ofair bag 82 before being somebody's turn to do.

Like this, through softish precedingdististyle 86 is set, can improve the trafficability characteristic of stenosis.

Patent documentation 1: (Japan) spy opens the 2008-237844 communique

At this, owing to utilizing blow molding etc.,air bag 82 forms, and therefore,, compare center side with the both end sides of axis direction and be easy to attenuate for the wall thickness of air bag 82.Like this, be wound under the state ofinside tube 84 at theair bag 82 of contraction state,straight tube zone 82c side is easy to reduction than the regional 82e side of amphi position side stand rigidity.Under this situation, its inflexible transformation part might produce distortion (bending).

Summary of the invention

The present invention is In view of the foregoing and accomplishes, and its purpose is in the balloon catheter of the flexibility that has improved the amphi position end, to realize to be provided with the inflexible optimization in the zone of air bag.

Below, in order to solve above-mentioned problem, effect is represented on the limit as required, effect is equilateral describes to effective means etc.

First invention provides a kind of balloon catheter, possesses: air bag, and it utilizes fluid to expand or shrinks; Body, it generates the tube chamber that lead is used, and covers the amphi position side by said air bag, and said balloon catheter is characterised in that said air bag possesses: amphi position side engagement zone, it constitutes the joint with respect to the amphi position side of said body; Expand with the zone, it is projected into outermost part when being formed in said airbag inflation; Transitional region, it is located at said amphi position side engagement zone and said expansion with between the zone, and said body possesses: first manages; Second pipe; It is in position and this first pipe joint setting of leaning on proximal side than this first pipe; And rigidity is higher than this first pipe; This second pipe extends with the mode of leaning on the position of proximal side to get in the space that is surrounded by this transitional region from the boundary member of using zone and said transitional region than said expansion; And the amphi position end that forms said second pipe does not get into the position that is surrounded by said amphi position side engagement zone; Be made as L1, will be made as under the situation of L2 with the boundary member of zone and the said transitional region length dimension to the axis direction of the amphi position end of said second pipe from said expansion at the length dimension with the axis direction of said transitional region, L2/L1 is more than 0.28.

According to this formation, can give the rigidity of appropriateness to the transitional region by air bag of body from the zone of outer side covers, even it is lower than amphi position side rigidity with area side to expand in the air bag, also can be with this variation in rigidity suitable absorption in body.Therefore, can realize the raising of warp resistance property.In addition, because be that the joint that second pipe and first is managed does not get into the regional formation of amphi position side engagement,, can when making the lead tracing ability good, as above realize the raising of warp resistance property so can suppress the situation that the rigidity of the amphi position side of balloon catheter extremely increases.In addition, if this formation, then because as long as as the position of the amphi position end of above-mentioned setting second pipe just passable, so facilitation that can the adjustment of realization load balance on the basis of the action effect that produces above-mentioned excellence.

Second invention is on the basis of first invention, and said balloon catheter is characterised in that said L2/L1 is below 0.72.Thus, can realize the raising of above-mentioned warp resistance property and the raising of lead tracing ability simultaneously.

The 3rd invention is on the basis of first or second invention; Said balloon catheter is characterised in that; Said body possesses tee pipe; It is in position and this first pipe joint setting of leaning on the amphi position side than said first pipe, and rigidity is lower than this first pipe, and the joint of said first pipe and said tee pipe is present in the position of leaning on the amphi position side than the border in said transitional region and said amphi position side engagement zone on axis direction.Thus, as stated, in the formation of the raising of the tracing ability of raising that has realized warp resistance property and lead, also can realize the raising of the trafficability characteristic of stenosis.

The 4th invention is on the basis of the 3rd invention; Said balloon catheter is characterised in that; The material that forms said first pipe is than the high material of material hardness that forms said tee pipe; Said first pipe is present in the position of leaning on the amphi position side than said amphi position side engagement zone with the joint of said tee pipe on axis direction, and is the zone of the formation material of the formation material that comprises said first pipe and said tee pipe, and this regional outer peripheral face is formed by said first material that forms of managing; Perhaps in forming the material of this regional outer peripheral face, the formation material that contains the said tee pipe of ratio of the formation material of said first pipe contain proportional height.

Lean on the position of amphi position side because the joint of first pipe and tee pipe is present in than amphi position side engagement zone on axis direction, thereby can realize the raising of the supporting stability of the air bag in the body, and can improve the distolateral flexibility of amphi position.In addition; In such formation, at the joint of first pipe and tee pipe, because have the high material of hardness at its outer peripheral face; So the effect that can suppress the external force etc. because of through stenosis the time makes the situation of outer peripheral face extreme deformation of leaning on the part of amphi position side than air bag that reaches.

The 5th invention provides a kind of balloon catheter, possesses: air bag, and it utilizes fluid to expand or shrinks; Body, it generates the tube chamber that lead is used, and covers the amphi position side by said air bag, and said balloon catheter is characterised in that said air bag possesses: amphi position side engagement zone, it constitutes the joint with respect to the amphi position side of said body; Expand with the zone, it is projected into outermost part when being formed in said airbag inflation; Transitional region; It is located at said amphi position side engagement zone and said expansion with between the zone; Mensuration load under the enforcement cantilever bending test situation presents the position that exists from the border of the said amphi position side engagement zone of air bag described in the said body and said transitional region and begins more towards the big more tendency of proximal side; And get into the position of 5/6 distance measurements of the axis direction length dimension of the said transitional region of proximal side in the position that exists from said border; Said mensuration load is more than the 1gf; Said cantilever test makes the said supporting station 1mm of the distance place of this body pass through probe to bottom offset 0.5mm for the amphi position side is stretched out body under the state that level keeps on the support platform.

According to this formation, though be the expansion of air bag with area side than the low formation of amphi position side rigidity, also can this variation in rigidity suitable absorption in body be realized the raising of warp resistance property.

The 6th invention is on the basis of the 5th invention, and said balloon catheter is characterised in that, the position of border existence that said mensuration loads on said amphi position side engagement zone and the said transitional region of air bag described in the said body is below the 1.1gf.Thus, can realize the raising of above-mentioned warp resistance property and the raising of lead tracing ability simultaneously.

Description of drawings

Fig. 1 (a) is air bag and the peripheral side view thereof under the swelling state with the STA representation air bag and the outboard tube in vertical section; (a1) be the figure that the air bag under the state in vertical section is amplified its part expression; (a2) be the profilograph that the part of inside tube is amplified expression; (a3) be the profilograph that the part of air bag and inside tube is amplified expression; (b) be this air bag and the side view of periphery thereof when being illustrated in air bag and being contraction state;

Fig. 2 (a)～(d) is this air bag and the side view of periphery thereof when being illustrated in air bag and being swelling state, is the different respectively figure of length dimension of inboard peri position pipe;

Fig. 3 is the summary unitary side view of the formation of expression balloon catheter;

Fig. 4 (a) is the sketch map of the state of expression cantilever bending test; (b) be the result's of expression cantilever bending test figure;

Fig. 5 is the front view of the assay device of the expression evaluation that is used to carry out warp resistance property and lead tracing ability;

Fig. 6 (a) is the figure of the result of the test of expression comparative example 1; (b) be the figure of the result of the test ofexpression embodiment 5; (c) be the figure of the result of the test of expression embodiment 6; (d) be the figure of the result of the test of expression embodiment 7; (e) be the figure of the result of the test of expression embodiment 8;

Fig. 7 is the figure that is used to explain background technology, is with the air bag STA representation air bag in vertical section and outboard tube, under the swelling state and the side view of periphery thereof.

Symbol description

10 ... Balloon catheter, 13 ... Air bag, 13c ... Straight tube zone, 13d ... Amphi position side conical region, 13e ... Amphi position side stand zone, 15 ... Outboard tube, 16 ... Inside tube, 32 ... Inboard peri position pipe, 33 ... Inboard intervalve, 34 ... Inboard amphi position pipe, 36 ... First joint, 38 ... Second joint.

The specific embodiment

Below, based on one of description of drawings balloon catheter embodiment.At first, explain that with reference to Fig. 3 the summary ofballoon catheter 10 constitutes.Fig. 3 is the summary unitary side view of the formation ofexpression balloon catheter 10.

As shown in Figure 3,balloon catheter 10 possess conduit withpipe 11, be installed on this conduit with cover joint (the Ha Block) 12 of the peri position end (base end part) ofpipe 11, be installed on theair bag 13 of conduit with the amphi position distolateral (front) of pipe 11.In addition, the length dimension ofballoon catheter 10 is 1m～2m.

Conduit is made up of a plurality of pipes withpipe 11, multitube structure inside and outside the position from the half-way of axis direction (length direction) toair bag 13 becomes at least.Particularly, conduit withpipe 11 possessoutboard tube 15, than thisoutboard tube 15 insidetube 16 of footpathization more carefully, through forming the inside and outside dual tubular construction with being inserted intooutboard tube 15 in the inside tube 16.Insidetube 16 is equivalent to body.

Outboard tube 15 forms has the tubulose continuously whole and pore 21 (with reference to Fig. 1) in the outside of both ends open on axis direction.In addition,outboard tube 15 possesses: the outsideperi position pipe 22 that is formed by metals such as Ni-Ti alloy or rustless steels; Relatively this outsideperi position pipe 22 in the amphi position side outsideintervalve 23 continuous and that form by the thermoplastic polyamide elastomer with the mode lower than outsideperi position pipe 22 rigidity; Relatively thisoutside intervalve 23 in the amphi position side outsideamphi position pipe 24 continuous and that form by the thermoplastic polyamide elastomer with the mode lower thanoutside intervalve 23 rigidity.

Need to prove, also can form outsideperi position pipe 22 by synthetic resin.In addition, the formation material ofoutside intervalve 23 and outsideamphi position pipe 24 is not limited to the thermoplastic polyamide elastomer, also can be formed by other synthetic resin, can also be for metallic braided tube or metallic coil being embedded in the formation of plastic wall portion.In addition, in this manual, rigidity is meant will be with conduit to the size of the moment of effect when crooked with the orthogonal direction of axis direction.

As shown in Figure 1, insidetube 16 forms to be had on axis direction continuously whole and at the tubulose of theinboard pore 31 of both ends open.In addition, as shown in Figure 3, insidetube 16 is provided with as follows; Its peri position engaged at end is in the half-way of the axis direction ofoutboard tube 15, particularly be engaged in the border ofoutside intervalve 23 and outsideamphi position pipe 24; And, compareoutboard tube 15, it extends to and more leans on the amphi position side.And, be provided withair bag 13 with mode from this extended zone of outer side covers.

Need to prove thatoutside pore 21 is brought into play function as the fluid of compressed fluid circulation whenair bag 13 being expanded or shrink with tube chamber.Inboardpore 31 is brought into play function as the lead of inserting admittance line G with tube chamber.In addition; As shown in Figure 3; It is the so-called RX type conduit of the half-way of the peri position end opening 31a of inboardpore 31 axis direction that is present inballoon catheter 10; But being not limited thereto, also can be so-called OTW (オ one バ one ザ ワ イ ヤ) the type conduit that the peri position end opening 31a ofinboard pore 31 is present in the peri position end ofballoon catheter 10.

Below, specify the formation ofair bag 13 and insidetube 16 with reference to Fig. 1.

Fig. 1 (a) isair bag 13 and the peripheral side views thereof under the expression swelling state with vertical section STArepresentation air bag 13 and outboard tube 15.Fig. 1 (a1) is the figure that the part of the air bag under the state ofvertical section 13 is amplified expression, and Fig. 1 (a2) is the profilograph that the part ofinside tube 16 is amplified expression, and Fig. 1 (a3) amplifies the profilograph of expression with the part ofair bag 13 and inside tube 16.Fig. 1 (b) is thisair bag 13 and the peripheral side view thereof when representingair bag 13 for contraction state.

Air bag 13 is formed by polyamide thermoplastic.But be not limited to this, also can form by other synthetic resin such as polyolefin, polyolefin elastomer, polyester, polyester elastomer, polyamide elastomer, polyimides, polyimides elastomer, polyurethane, polyurethane elastomer, polyethylene terephthalate, silicone rubber, styrene olefinic rubbers.In addition, also can form, under this situation, can form single layer structure, also can form multiple structure by the material that mixes more than two kinds in above-mentioned synthetic resin of enumerating or the above-mentioned polyamide elastomer.

Manufacturing approach forair bag 13 does not limit especially, can enumerate manufacturing approaches such as blow molding, dip mold, extrusion molding.But the narrow that produces in to the coronary artery at heart is carried out under the situation of dilation therapy, and preferredair bag 13 has sufficient comprcssive strength, and this moment is preferred uses blow molding.

Shown in one of method of utilizing this blow moldinggas making capsule 13 is for example following.At first, the basis that utilizes extrusion molding to makeair bag 13 is a tubular parison.Then, after this tubular parison is extended along its length, use the mould that forms the model corresponding, under rated condition, carry out blow molding with the shape of air bag 13.Thus, form the state that the tubular parison diaxon has been extended.The manufacturing ofair bag 13 is accomplished at the two ends of the tubular parison of having extended through cut-out afterwards.In addition, above-mentioned blow molding both can be carried out at ambient temperature, also can under heating condition, carry out.In addition, also can carry out repeatedly this blow molding.Can also carry out the extension of axial extension and radial direction simultaneously.Also can extend back etc. at diaxon anneals.

Shown in Fig. 1 (a),air bag 13 forms with internal diameter and the multistage alternative mode of external diameter under swelling state.That is,air bag 13 begins from proximal side to have successively: the proximal side stent area that engages with outboard tube 15 (proximal side engaging zones) 13a; Form cone shape proximal side conical region (transitional region of proximal side) 13b towards front with mode with internal diameter and the continuous hole enlargement of external diameter; Internal diameter and external diameter are identical and be straight tube zone (expanding with the zone) 13c in the maximum outside diameter zone ofair bag 13 on whole length direction; Form cone shape amphi position side conical region (transitional region of amphi position side) 13d towards front with the mode of internal diameter and external diameter being carried out continuously undergauge; The amphi position side stand zone that engages with inside tube 16 (amphi position side engagement zone) 13e.

The length dimension of the axis direction of proximalside stent area 13a is 0.5mm～5.0mm; The length dimension of the axis direction of proximal sideconical region 13b is 0.5mm～10.0mm; The length dimension of the axis direction ofstraight tube zone 13c is 5mm～50mm; The length dimension of the axis direction of amphi position sideconical region 13d is 2.5mm～15.0mm, and the length dimension of the axis direction of amphi positionside stand zone 13e is 0.5mm～2.0mm.In addition, the external diameter of thestraight tube zone 13c whenair bag 13 expands is 1.0mm～5.0mm, and the external diameter of thestraight tube zone 13c of (, the state thatair bag 13 is folded) is 0.5mm～1.5mm during contraction before the expansion of air bag 13.In addition, the wall thickness ofstraight tube zone 13c is 0.01mm～0.3mm, and the wall thickness of the amphi position end of amphi position sideconical region 13d is 0.03mm～0.5mm.

The length dimension of the axis direction of amphi position sideconical region 13d is preferably 4.0mm～13.0mm, more preferably 5.0mm～11.0mm.Thus, can do one's utmost to alleviate the inclination of this amphi position side conical region 13d.Therefore; Shown in Fig. 1 (b); Shrink atair bag 13; And the proximal sideconical region 13b ofair bag 13,straight tube zone 13c and amphi position sideconical region 13d are wound up under the state of outer peripheral face ofinside tube 16, and in that distolateral the variation of the part external diameter of 13c slows down to the straight tube zone from amphi position, the trafficability characteristic when insertingballoon catheter 10 in the bodies improves.

Need to prove, in the formation thatair bag 13 is formed by a plurality of wing formulas (for example 3 wing formulas), be the state that these each wings are wound ininside tube 16 respectively under the contraction state of air bag 13.In detail; Under the situation ofair bag 13 from the swelling state to the contraction state; Expansion and constriction zone (proximal sideconical region 13b,straight tube zone 13c and amphi position sideconical region 13d) with the mode foldedairbag 13 that uniformly-spaced forms a plurality of vertical wings that stand up with axis direction; Afterwards, form the contraction state that each wing is wound ininside tube 16.

Insidetube 16 forms through a plurality ofpipes 32～34 are arranged to link with the mode on same axis.Particularly, possess: constitute peri position end frominside tube 16 to the inboardperi position pipe 32 that more leans on the half-way of amphi position side thanoutboard tube 15; Relatively should inboardperi position pipe 32 at the successiveinboard intervalve 33 of amphi position side; Relatively should inboard intervalve 33 in the amphi position side continuously and constitute the inboardamphi position pipe 34 of the amphi position end of inside tube 16.Need to prove that inboardperi position pipe 32 is equivalent to second pipe,inboard intervalve 33 is equivalent to first pipe, and inboardamphi position pipe 34 is equivalent to tee pipe.

Inboardperi position pipe 32 is formed by synthetic resin, particularly, forms the three-decker that the synthetic resin of range upon range of a plurality of kinds forms.In detail, skin is formed by the thermoplastic polyamide elastomer who is equivalent to Shore hardness 70D, and the intermediate layer is formed by low density polyethylene (LDPE), and internal layer is formed by high density polyethylene (HDPE).In addition, for the ease of explanation, inboardperi position pipe 32 is expressed as monolayer among Fig. 1 (a2).

Inboard intervalve 33 is formed by synthetic resin, and forms single layer structure.Inboard intervalve 33 uses the low resin material of Shore hardness of comparing the thermoplastic polyamide elastomer who in inboardperi position pipe 32, utilizes to form.In detail, form, particularly form by the polyamide elastomer that is equivalent to Shore hardness 63D by the low thermoplastic polyamide elastomer of Shore hardness who compares the thermoplastic polyamide elastomer who in inboardperi position pipe 32, utilizes.

Inboardamphi position pipe 34 is formed by synthetic resin, and forms single layer structure.Inboardamphi position pipe 34 uses the low resin material of Shore hardness of comparing the thermoplastic polyamide elastomer who ininboard intervalve 33, utilizes to form.In detail, form, particularly form by the polyamide elastomer that is equivalent to Shore hardness 55D by the low thermoplastic polyamide elastomer of Shore hardness who compares the thermoplastic polyamide elastomer who ininboard intervalve 33, utilizes.

Need to prove that the formation material of inboardperi position pipe 32,inboard intervalve 33 and inboardamphi position pipe 34 is not limited to above-mentioned material.

For example, also can use synthetic resin such as polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyamide, polyamide elastomer, polyimides, polyimides elastomer, silicone rubber that inboardperi position pipe 32 is formed the multiple structure different with aforementioned tube.In addition, also can not form multiple structure, and be to use the above-mentioned synthetic resin of enumerating etc. to form single layer structure.Under this situation, can form by a kind of independent synthetic resin, also can be by mixed material more than two kinds is formed.

In addition, also can inboard intervalve 33 and inboardamphi position pipe 34 be used synthetic resin such as polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyamide, polyimides, polyimides elastomer, silicone rubber respectively independently and form.Under this situation, can form single layer structure same as described abovely, and, both can this single layer structure be formed by a kind of independent synthetic resin, also can be by two or more mixed materials are formed.In addition, also can use above-mentioned synthetic resin of enumerating etc. to form multiple structure.

For this multiple structure, identical with above-mentioned inboard periposition pipe 32, also can form following formation: outerly formed by polyamide elastomer, the intermediate layer is formed by low density polyethylene (LDPE), and internal layer is formed by high density polyethylene (HDPE).Under this situation; Though inboardperi position pipe 32,inboard intervalve 33 and inboardamphi position pipe 34 form identical multiple structure, the Shore hardness that also can generate outer field synthetic resin (being specially polyamide elastomer) is set to the relation of inboardperi position pipe 32＞inboard intervalve 33＞inboardamphi position pipe 34.

In inboardperi position pipe 32, extend to and more lean on the zone of amphi position side to form thanoutboard tube 15 to attenuate towards amphi position side stage.Particularly, on this extended zone, more lean on the amphi position side mode thinner to be formed withstage portion 32a to compare this half-way than proximal side in the half-way of axis direction.Thereby, inboardperi position pipe 32 have thanstage portion 32a lean on proximal sidebig footpath zone 32b, compare thepath zone 32c that stageportion 32a leans on the amphi position side.In addition, the internal diameter of thesebig footpath zone 32b andpath zone 32c is identical.Therefore,path zone 32c comparesbig footpath zone 32b, its wall thickness.

At this, above-mentionedpath zone 32c forms as follows, that is, utilize extrusion molding etc. and form pipe with the mode that becomes fixed outer diameter and fixed inner diameter, and the amphi position side that makes this pipe is extended and formedpath zone 32c along axis direction.Thus, improved the intensity of path zone 32c.That is, inboardperi position pipe 32 forms operation, the extension process of the half-way extension of the Guan Congqi axis direction that utilizes this pipe to form operation formation is formed through the pipe that is used to form external diameter and the fixed pipe of internal diameter.Need to prove, both can carry out repeatedly extension process, the operation that also can behind extension process, carry out pipe is cut off for the length dimension withpath zone 32c forms the size of regulation.

The 32c in the path of inboardperi position pipe 32 zone for the identity that improves theair bag 13 under X line projection and be easy to carry out 13 pairs of location that become treatment place of purpose of air bag, is equipped with themetal radiography ring 35 that forms tubular at its outer peripheralface.Radiography ring 35 is formed by rustless steel, but is not limited thereto, and also can use gold, platinum, iridium, cochrome, titanium etc.The distolateral end face of the peri position ofradiography ring 35 is provided with from amphi position side andstage portion 32a butt.Thus, whenballoon catheter 10 inserts in body or during the narrow positions ofair bag 13 periphery through blood vessel,, also can bear this load, thereby prevent the dislocation ofradiography ring 35 bystage portion 32a evenradiography ring 35 has been applied load to proximal side.In addition,radiography ring 35 comprises the middle position ofstraight tube zone 13c and disposes on axis direction.

Path zone 32c forms external diameter and internal diameter is fixing on axis direction, theinboard intervalve 33 of amphi position engaged at end of 32c in this path zone.Inboard intervalve 33 its external diameters and internal diameter are fixing on axis direction, and its external diameter and internal diameter are identical with external diameter and the internal diameter of path zone 32c.In addition; Inboardamphi position pipe 34 forms with external diameter and the fixed mode of internal diameter before the half-way of axis direction; External diameter and the internal diameter of its external diameter and internal diameter andpath zone 32c are identical, begin from the half-way of axis direction, through fixed inner diameter limit, limit make its be tapered form coniform.

In the formation of the external diameter of settingpath zone 32c,inboard intervalve 33 and inboardamphi position pipe 34 like this and internal diameter; As above state bright; Inboard intervalve 33 forms by comparing the low material of inboardperi position pipe 32 Shore hardness, and inboardamphi position pipe 34 forms by comparing the low material ofinboard intervalve 33 Shore hardness.Therefore,inboard intervalve 33 is set at that to comparepath zone 32c rigidity low, and inboardamphi position pipe 34 is set at that to compareinboard intervalve 33 rigidity low.

Through as above forming insidetube 16, the rigidity of thisinside tube 16 is towards the interim reduction of amphi position side.Thus, can realize to the blood vessel of bending tracing ability, from the reception and registration property of the power of proximal side, and the raising of warp resistance property.

Below, the joint ofinboard intervalve 33 and inboardamphi position pipe 34 is described.

Shown in Fig. 1 (a3), the joint ofinboard intervalve 33 and inboard amphi position pipe 34 (below, be also referred to as first joint 36) be present in than the regional 13e of the amphi position side stand ofair bag 13 and more lean on the amphi position side.That is, the amphi position side standzone 13e thatinboard intervalve 33 extends to thanair bag 13 more leans on the amphi position side, extends the place, back at it and engages inboard amphi position pipe 34.Thus, can improve the flexibility of the amphi position end ofballoon catheter 10, this amphi position end is easy to be out of shape according to the shape at angiostenosis place.Thus, can improve the trafficability characteristic of stenosis.

For first joint 36, do in detail, the amphi position end open side ofintervalve 33 is inserted the peri position end of inboardamphi position pipe 34 to the inside, and heating is applied two pipes, 33,34 thermosols from the outside to this insert division, forms this first joint 36 thus.This thermosol applies under following state and carries out; Promptly comprising first joint 36 and inserting with the identical or roughly the same mode of the internal diameter ofinside tube 16 under the state of axle and carry out; And; This thermosol applies and to carry out through following mode, promptly utilizes heat-shrinkable tube etc. to add hot compression from the outside, makes the joint 36 of winning not produce jump ground and forms simultaneously at this first joint 36 and peripheral outer peripheral face thereof.

First joint 36 is the zone that comprises material that formsinboard intervalve 33 and the material both sides that form inboard amphi position pipe 34.In detail, first joint 36 be theinboard intervalve 33 of inside and outside stratification material layer and the material that forms inboardamphi position pipe 34 layer the zone, and the state that in the prescribed limit of axis direction, extends for this lamination area.Under this situation, at first joint 36, form inboardintervalve 33 material layer and form the high side of hardness in the layer of material of inboardamphi position pipe 34, outer peripheral face that the layer that promptly forms the material ofinboard intervalve 33 generates inside tube 16.Need to prove that joint method is not limited to thermosol and applies, and also can utilize binding agent.

First joint 36 is not limited to the formation of layer of layer and the material that forms inboardamphi position pipe 34 of the material of theinboard intervalve 33 of stratification, the formation that also can on the wall thickness direction, change for the mixed proportion of these each materials.Particularly, also can be that the outer peripheral face side ofinside tube 16 is high and disperse each material towards the low more mode of inner peripheral surface more by the mixed proportion of the material that forms inboard intervalve 33.Under this situation; On the outer peripheral face ofinside tube 16; Both can form that individualism forms the material ofinboard intervalve 33 and the formation that do not have the material that forms inboardamphi position pipe 34; Though also can form the material height that the ratio of the material that formsinboard intervalve 33 forms inboardamphi position pipe 34, also have the formation of the material that forms inboardamphi position pipe 34.

As above-mentioned, at first joint 36, the material that formsinboard intervalve 33 generates outer peripheral face, or in outer peripheral face, forms the mixed proportion height of the material ofinboard intervalve 33, thereby can improve the hardness of the outer peripheral face side of first joint 36.Thus, in the formation of the trafficability characteristic that has improved stenosis like this, can suppress because the external force during through stenosis etc. makes the situation of outer peripheral face extreme deformation of leaning on the part of amphi position side thanair bag 13 that extends to.

In addition, on the basis of the resistance to sliding that is reduced in theinside tube 16 slotting lead G that lead to, preferably the hardness at first joint, 36 inner peripheral surfaces is high.Therefore, realizing under the situation that this resistance to sliding reduces,, preferably make the material that formsinboard intervalve 33 generate inner peripheral surface, or in inner peripheral surface, improve the mixed proportion of the material that formsinboard intervalve 33 at first joint 36.

First joint, 36 global existences are in the more amphi position side of the amphi position side stand zone ofair bag 13 13e.Thus, the amphi position side stand ofair bag 13zone 13e is engaged in the inboardamphi position pipe 34 or first joint 36, but is engaged in the state of inboard intervalve 33.For the flexibility of the amphi position end of improvingballoon catheter 10 and be provided with in the formation of inboardamphi position pipe 34; Though can consider amphi position side standzone 13e is engaged in the formation of the inboardamphi position pipe 34 or first joint 36; But by comparison; Through amphi position side standzone 13e is engaged in thehigh inboard intervalve 33 of rigidity, can improve the supporting stability of theair bag 13 in theinside tube 16.

As above state brightly, ininside tube 16, extend to the zone of leaning on the amphi position side thanair bag 13 and begin to be tapered to the amphi position end from the half-way of axis direction, but first joint 36 than thiszone 37 that is tapered by proximal side.Like this,, thereby the attenuation of first joint 36 can be suppressed, the bond strength of first joint 36 can be improved owing to first joint 36 does not overlap with thezone 37 that is tapered.But, on the basis of the further raising of the trafficability characteristic that realizes stenosis, can comprise that also at least a portion that generates first joint, 36 places forms thezone 37 that is tapered.

As above; For the rigidity of the amphi position side that reducesballoon catheter 10 and be provided with in the formation of the pipe lower than these inboardperi position pipe 32 rigidity in the amphi position side of inboardperi position pipe 32; As the low pipe of this rigidity; Inboard intervalve 33 and inboardamphi position pipe 34 are set, and the joint 36 of thesepipes 33,34 is present in the position of leaning on the amphi position side than air bag 13.Thus, can realize theair bag 13 in theinside tube 16 supporting stability raising and realize the raising of the trafficability characteristic of stenosis.

But; State the raising of warp resistance property after this is formed in and realizes and the two formation that gets both of raising of the tracing ability of lead G concerned that the aspect is for constitute arbitrarily; For example; Can also can not possess inboardamphi position pipe 34 for the amphi position side stand ofair bag 13zone 13e being engaged in the formation of first joint 36, can also with should inboardamphi position pipe 34 by forming than the high material ofinboard intervalve 33 hardness.

Below, the joint of inboardperi position pipe 32 andinboard intervalve 33 is described.

Shown in Fig. 1 (a2); The amphi position end that the joint of inboardperi position pipe 32 and inboard intervalve 33 (below be also referred to as second joint 38) inserts inboardperi position pipe 32 through the peri position end opening side ofintervalve 33 to the inside, and to this insert division heating makes two pipes, 32,33 thermosols apply and form from the outside.This thermosol applies under following state and carries out; Promptly comprising second joint 38 and inserting with the identical or roughly the same mode of the internal diameter ofinside tube 16 under the state of axle and carry out; And; This thermosol applies and to carry out through following mode, promptly utilizes heat-shrinkable tube etc. to add hot compression from the outside, makes second joint 38 not produce jump ground and forms simultaneously at this second joint 38 and peripheral outer peripheral face thereof.

Second joint 38 is the zone that comprises material that forms inboardperi position pipe 32 and the material both sides that form inboard intervalve 33.In detail, second joint 38 be the inboardperi position pipe 32 of inside and outside stratification material layer and the material that formsinboard intervalve 33 layer the zone, and the state that in the prescribed limit of axis direction, extends for this lamination area.Under this situation, at second joint 38, form inboard periposition pipe 32 material layer and form the high side of hardness in the layer of material ofinboard intervalve 33, inner peripheral surface that the layer that promptly forms the material of inboardperi position pipe 32 generates inside tube 16.Need to prove that joint method is not limited to thermosol and applies, and also can utilize binding agent.

Second joint 38 is not limited to the formation of layer of layer and the material that formsinboard intervalve 33 of the material of the inboardperi position pipe 32 of stratification, the formation that also can on the wall thickness direction, change for the mixed proportion of these each materials.Particularly, also can be that the inner peripheral surface side height ofinside tube 16 and the mode that the outward side face is low are more more disperseed each material by the mixed proportion of the material that forms inboard peri position pipe 32.Under this situation; On the inner peripheral surface ofinside tube 16; Both can form that individualism forms the material of inboardperi position pipe 32 and the formation that do not have the material that formsinboard intervalve 33; Though also can form the material height that the ratio of the material that forms inboardperi position pipe 32forms inboard intervalve 33, also have the formation of the material that formsinboard intervalve 33.

As above-mentioned, at second joint 38, the material that forms inboardperi position pipe 32 generates inner peripheral surface, or in inner peripheral surface, forms the mixed proportion height of the material of inboardperi position pipe 32, thereby can improve the hardness of the inner peripheral surface side of second joint 38.Thus, can reduce the resistance to sliding of lead G.Need to prove,, on the basis of the hardness that improves the outer peripheral face side, be preferably formed the mixed proportion that material generates outer peripheral face or raising forms the material of inboardperi position pipe 32 in outer peripheral face of inboardperi position pipe 32 at second joint 38.

Shown in Fig. 1 (a), the position of second joint 38 is set to the amphi position end (being the border of the inboardperi position pipe 32 and second joint 38) of inboardperi position pipe 32 and on axis direction, leans on the amphi position side and depend on proximal side to exist than the amphi position sideconical region 13d ofair bag 13 and the border of amphi position side standzone 13e than thestraight tube zone 13c ofair bag 13 and the border of amphi position side conical region 13d.Below, specify the inlet of the amphi position side ofperi position pipe 32 to the inside with reference to Fig. 2.

Fig. 2 (a)～(d) is thisair bag 13 and the peripheral side view thereof when representingair bag 13 for swelling state, and above-mentioned separately inlet is different among Fig. 2 (a)～(d).In addition, Fig. 2 (a)～(d) is with the STArepresentation air bag 13 and theoutboard tube 15 in vertical section.

Mode shown in Fig. 2 (a) is identical with the above-mentioned inlet of mode shown in Fig. 1 (a).Under this situation; Be made as L1 at length dimension with the axis direction of amphi position sideconical region 13d, when will length dimension being made as L2 from the boundary member ofstraight tube zone 13c and amphi position sideconical region 13d to the axis direction of the amphi position end of inboardperi position pipe 32; L1 is 9.0mm, and L2 is 4.5mm.At this moment, L2/L1 is 0.5.That is, the amphi position end of inboardperi position pipe 32 is present in the centre position of amphi position sideconical region 13d on axis direction.

In the mode shown in Fig. 2 (b), L1 is 9.0mm, and L2 is 2.5mm.This moment, L2/L1 was 0.28.That is, the amphi position end of inboardperi position pipe 32 is present in the position of leaning on proximal side than the border ofstraight tube zone 13c and amphi position sideconical region 13d by the amphi position side and than the centre position of amphi position sideconical region 13d on axis direction.

In the mode shown in Fig. 2 (c), L1 is 9.0mm, and L2 is 6.5mm.At this moment, L2/L1 is 0.72.In addition, in the mode, L1 is 9.0mm shown in Fig. 2 (d), and L2 is 8.5mm.At this moment, L2/L1 is 0.94.Promptly; In the mode shown in these Fig. 2 (c) and Fig. 2 (d), the amphi position end of inboardperi position pipe 32 is present in the position of leaning on proximal side than the centre position of amphi position sideconical region 13d by the amphi position side and than the border of amphi position sideconical region 13d and amphi position side standzone 13e on axis direction.

At this, shown in Fig. 1 (a1),air bag 13 forms usually from the two ends of axis direction and reduces gradually tostraight tube zone 13c wall thickness.This tendency is particularly remarkable under the situation of utilizing above-mentioned blow molding formation air bag 13.Like this, under the situation of observing withair bag 13 monomers,straight tube zone 13c side is lower than the distolateral rigidity of amphi position.Under this situation, when supposition when this scope global existence is used to improve the pipe of flexibility ofinboard intervalve 33, can not the anxiety that produce distortion be arranged in the influence of the variation in rigidity of the above-mentionedair bag 13 ofinside tube 16 side absorbent.

Relative with it, the mode shown in Fig. 2 (a)～(d) gets into the space that is covered by amphi position sideconical region 13d through the inboardperi position pipe 32 that extends fromoutboard tube 15 side direction amphi position sides at axis direction, can suppress the generation of above-mentioned distortion.In addition, the mode shown in Fig. 2 (a)～(d), proximal side is leaned on than the border of amphi position sideconical region 13d and amphi position side standzone 13e in the amphi position end of inboardperi position pipe 32 on axis direction.Thus, the flexibility of the amphi position side ofballoon catheter 10, the tracing ability of 10 couples of lead G of raising balloon catheter can be guaranteed, and the generation of above-mentioned distortion can be suppressed.

On the basis of the generation of the above-mentioned distortion of appropriate inhibition, above-mentioned L2/L1 is preferably more than 0.28, more preferably more than 0.35.In addition, for the value of L2, be under the situation more than the 9.0mm at L1, be preferably more than the 2.5mm, more preferably more than the 3.2mm.

On the basis of suitable raising to the tracing ability of above-mentioned lead G, above-mentioned L2/L1 is preferably below 0.72, more preferably below 0.6.In addition, for the value of (L1-L2), be under the situation more than the 9.0mm at L1, be preferably more than the 2.5mm, more preferably more than the 3.6mm.

In addition; On the basis of the generation that suppresses above-mentioned distortion; The position of border existence that preferred mensuration load when implementing the cantilever test presents amphi position side stand zone 13e and the amphi position side conical region 13d of air bag 13 from inside tube 16 begins more towards the big more tendency of proximal side; And get into the position of 5/6 distance measurements of the axis direction size L1 of proximal side amphi position side conical region 13d in the position that exists from this border; Measuring load is more than the 1gf; The test of above-mentioned cantilever is being for stretching out the amphi position side inside tube 16 supported under the state that level keeps on the platform, make apart from this horizontal stand 1mm sentence probe speed 0.5mm/min utilize probe (contact surface of front end is the rectangular planes of 10mm * 0.2mm) along vertical to bottom offset 0.5mm.In addition, the mensuration load of position that the position that more preferably exists from above-mentioned border gets into 11/18 the distance measurements of the above-mentioned size L1 of proximal side is more than the 1gf.On the other hand, on the basis of improving the tracing ability of above-mentioned lead G, the position of border existence that preferred said determination loads on amphi position side stand zone 13e and the amphi position side conical region 13d of inside tube 16 is below the 1.1gf, more preferably below the 0.8gf.

Reaching under the situation of above-mentioned load balance; On the basis of the raising of the tracing ability of raising that realizes warp resistance property and lead G; Though the position of the amphi position end of inboardperi position pipe 32 can be provided with arbitrarily, the preferred position of the amphi position end of the inboardperi position pipe 32 of adjustment on the basis of the setting that is easy to realize above-mentioned load balance.

As above-mentioned; The position of the amphi position end through as above setting inboardperi position pipe 32 or be that the mode of The above results forms insidetube 16 with the mensuration load of above-mentioned cantilever test; Evenair bag 13 bestraight tube zone 13c side than the low formation of amphi position side rigidity, also can suitably absorb its variation in rigidity in inside tube 16.In addition, also can suitably improve the flexibility of the amphi position side of balloon catheter 10.Therefore, can make the lead tracing ability good and suppress the generation of the distortion that has amphi position sideconical region 13d place ofair bag 13.

This aspect that concerns of formation that is formed in the raising of the trafficability characteristic that realizes stenosis through inboardamphi position pipe 34 can be to constitute arbitrarily; For example can be that the amphi position end of inboardperi position pipe 32 gets into by the constituting of amphi position side standzone 13e covering place ofair bag 13, also can be this amphi position end than the border of thestraight tube zone 13c ofair bag 13 and the amphi position sideconical region 13d formation by proximal side.

Below, the method for using of simpledeclaration balloon catheter 10.

At first, insert logical guiding catheter, import to the coronary artery inlet portion through connecting operation to being inserted into endovascular sheath conductor (シ one ス イ Application ト ロ デ ユ one サ).Then, lead G is inserted theinboard pore 31 that leads toballoon catheter 10, import to the tip position through stenosis from the coronary artery inlet portion.Then, along lead G toballoon catheter 10 limits apply connect the operation limit be inserted into stenosis.

Under this situation, as above illustrated, through inboardamphi position pipe 34 is set, can improve the trafficability characteristic of stenosis.In addition; Because the amphi position end of inboardperi position pipe 32 is present on axis direction than leaning on the amphi position side and than the position by proximal side, the border of amphi position sideconical region 13d and amphi position side standzone 13e in the border ofstraight tube zone 13c and amphi position sideconical region 13d, so can improves the tracing ability of lead G and can suppress to be provided with the generation of distortion at the amphi position sideconical region 13d place of air bag 13.In addition,, can improve the reception and registration property of power according to above-mentioned formation, and, owing to can improve tracing ability to lead G, thus the stability of the configuration of guiding catheter can be improved.

Then, the use prelum injects compressed fluids in cover joint 12side airbag 13, makesair bag 13 expansions and makes obstruction place or the stenosis expansion.After finishing this dilation therapy, the compressed fluid that is injected in theair bag 13 through extraction shrinksair bag 13, carries outballoon catheter 10 from managing the interior extraction operation of extracting.

In addition,balloon catheter 10 mainly leads in the blood vessel as stated, is used to treat for example blood vessels such as coronary artery, thigh tremulous pulse, pulmonary artery, but also goes for biological intravital " pipes " or " body cavity " such as urinary catheter or digestive tubes beyond the blood vessel.

Embodiment

Specify through following examples and can improve the tracing ability of lead G and can suppress the formation of generation of the distortion that is provided with amphi position sideconical region 13d place ofair bag 13, but the present invention is not limited to this.

(embodiment 1)

The hollow pipe of outer field, the internal diameter 0.42mm of the intermediate layer of the thickness 0.004mm that utilizes extrusion modling to make to have the internal layer of the thickness 0.016mm that forms by high density polyethylene (HDPE) (PetrotheneLR7340 of M.holland society), forms by low density polyethylene (LDPE) (PlexarPX3080 of Equistar society), the thickness 0.06mm that forms by polyamide elastomer (Pebax7033 of ARKEMA society), external diameter 0.58mm, length 300mm.

Make scope apart from an end 10mm of this hollow pipe inserting to the inside under the fixing state of internal diameter, extend with anchor clamps by the extension of passing the circular port that is formed with internal diameter 0.52mm with axle.Afterwards, cut off the end of this extension side, make thus have internal diameter 0.41mm, thebig footpath zone 32b of external diameter 0.55mm, length 290mm, and the inboardperi position pipe 32 of thepath zone 32c of internal diameter 0.41mm, external diameter 0.52mm, length 10mm.The 32c in the path of this inboardperi position pipe 32 zone utilizes riveted joint and theradiography ring 35 of the internal diameter 0.55mm that formed by rustless steel, external diameter 0.60mm, length 1mm is installed.

Use polyamide elastomer (Pebax of ARKEMA society 6333) to utilize extrusion molding to make theinboard intervalve 33 of internal diameter 0.42mm, external diameter 0.55mm, length 9mm.Hole enlargement is carried out in end to the path of above-mentioned inboard periposition pipe 32zone 32c side, and above-mentionedinboard intervalve 33 is inserted in the zone after this hole enlargement, and with two pipes, 32,33 heating depositions.At this moment, fixing with axle and utilize heat-shrinkable tube to add hot compression from the outside through inserting internal diameter to the inside, the internal diameter of joint 38 and external diameter are identical with other position of other position of the regional 32c of path andinboard intervalve 33 respectively.

Use polyamide elastomer (Pebax of ARKEMA society 5533) to utilize extrusion molding to make the inboard amphi position pipe 34 of internal diameter 0.42mm, external diameter 0.55mm, length 1mm.Hole enlargement is carried out in amphi position end to above-mentioned inboard intervalve 33, and above-mentioned inboard amphi position pipe 34 is inserted in the zone after this hole enlargement, with two pipes, 33,34 heating depositions.At this moment, fixing with axle and utilize heat-shrinkable tube to add hot compression from the outside through inserting internal diameter to the inside, the internal diameter of joint 36 and external diameter are identical with other position of other position of inboard intervalve 33 and inboard amphi position pipe 34 respectively.Thus; Obtain inside tube 16; It is: the stage portion 32a of 32c and the big regional 32b in footpath is 8mm to the length of the amphi position end (being the peri position end of the joint 38 of inboard peri position pipe 32 and inboard intervalve 33) of this inboard peri position pipe 32 from the path of inboard peri position pipe 32 zone; The length of (being the amphi position end of the joint 36 of inboard intervalve 33 and inboard amphi position pipe 34) is 9mm to the amphi position end of inboard intervalve 33 from the amphi position end of inboard peri position pipe 32, and the length from the amphi position end of inboard intervalve 33 to the amphi position end of inboard amphi position pipe 34 is 1mm.

(embodiment 2)

Except the length of the amphi position end from above-mentionedstage portion 32a to above-mentioned inboard periposition pipe 32 is the 10mm, other makes insidetube 16 withembodiment 1 identically.

(embodiment 3)

Except the length of the amphi position end from above-mentionedstage portion 32a to above-mentioned inboard periposition pipe 32 is the 12mm, other makes insidetube 16 withembodiment 1 identically.

(embodiment 4)

Except the length of the amphi position end from above-mentionedstage portion 32a to above-mentioned inboard periposition pipe 32 is the 14mm, other makes insidetube 16 withembodiment 1 identically.

(evaluation of hardness balance)

Shown in Fig. 4 (a); The test of enforcement cantilever bending; And measure the bending load (gf) when giving as security time 0.5mm with probe D2; The test of this cantilever bending is being for supporting insidetube 16 to remain level on the platform D1 under the state more than the side-prominent 1mm with amphi position end, to from supporting contact surface that the outstanding 1mm of platform D1 utilizes front end downwards to apply load with probe speed 0.5mm/min along vertical for the rectangular planar probe D2 of 10mm * 0.2mm.In addition, when insidetube 16 is changed from the overhang of supporting platform D1, to carrying out mensuration everywhere based on the bending load of this cantilever bending test at every displacement 2mm in the scope of the amphi position end 1mm～25mm of inside tube 16.To be illustrated among Fig. 4 (b) this evaluation result of the foregoingdescription 1～4.

Need to prove; In Fig. 4 (b); Border 1 (apart from the position of the proximal side of the amphi position end 3.5mm of inside tube 16) is stated insidetube 16 in the use and is made under the situation ofballoon catheters 10 position for the axis direction of the border existence of the amphi position side standzone 13e ofair bag 13 and amphi position sideconical region 13d; Border 2 (apart from the position of the proximal side of the amphi position end 12.5mm of inside tube 16) is stated insidetube 16 in the use and is made under the situation ofballoon catheters 10, is the position of amphi position sideconical region 13d with the axis direction of the border existence ofstraight tube zone 13c ofair bag 13.

Shown in Fig. 4 (b), loading among theembodiment 1 ofborder 1 is about 0.6gf, inembodiment 2, is about 0.5gf, in embodiment 3, is about 0.8gf, in embodiment 4, is about 1.0gf.That is, the load on theborder 1 of the arbitrary example among theembodiment 1～4 all is below the 1.1gf, and the load onborder 1 is below the 0.8gf among theembodiment 1～3.

In addition, loading among theembodiment 1 ofborder 2 is about 1.6gf, inembodiment 2, is about 1.2gf, in embodiment 3, is about 1.3gf, in embodiment 4, is about 1.5gf.That is, the load on theborder 2 of arbitrary example all is more than the 1.2gf among theembodiment 1～4.

In addition; Inembodiment 2～4; Get into the position of 11/18 distance measurements of length dimension of the axis direction of proximal side amphi position sideconical region 13d in the position that apart from the position of the amphi position end 9mm ofinside tube 16, promptly exists from the border of amphi position sideconical region 13d and amphi position side standzone 13e; Load is more than the 1gf; Inembodiment 1, get into the position of 5/6 distance measurements of length dimension of the axis direction of proximal side amphi position sideconical region 13d in the position that apart from the position of the amphi position end 11mm ofinside tube 16, promptly exists from the border of amphi position sideconical region 13d and amphi position side standzone 13e, load is more than the 1gf.

Need to prove; Though the diagram of omission; But after state under the situation of inside tube of comparative example 1; Get into the position of 5/6 distance measurements of length dimension of the axis direction of proximal side amphi position sideconical region 13d in the position that apart from the position of the amphi position end 11mm ofinside tube 16, promptly exists from the border of amphi position sideconical region 13d and amphi position side standzone 13e, load is far below 1gf.

(embodiment 5)

Make the outsideperi position pipe 22 of internal diameter 0.5mm, external diameter 0.7mm, length 250mm by the Ni-Ti alloy; Use polyamide elastomer (Pebax7233 of ARKEMA society) to utilize extrusion molding to make theoutside intervalve 23 of internal diameter 0.70mm, external diameter 0.85mm, length 150mm, use polyamide elastomer (Pebax7233 of ARKEMA society) to utilize extrusion molding to make the outsideamphi position pipe 24 of internal diameter 0.70mm, external diameter 0.85mm, length 240mm.In addition, Merlon system cover joint 12 is installed in the peri position end ofperi position pipe 22 in the outside.

Use polyamide (the Rilsan TL of ARKEMA society) to utilize extrusion molding to make tubular parison, and utilize blow molding to carry out diaxon this tubular parison and extend, through cutting off the two ends makingair bag 13 of the tubular parison after this extensions.

The peri position end ofair bag 13 is applied through thermosol be engaged in the amphi position end of above-mentioned outsideamphi position pipe 24 after, will in theinside tube 16 that the foregoingdescription 1 is made, be inserted into above-mentioned outsideamphi position pipe 24 and form double-sleeve structure.And then; The mode ofamphi position pipe 24 to the extended zone of amphi position side disposes from the outside to cover ininside tube 16 with above-mentionedair bag 13; And after the amphi position end thermosol ofair bag 13 spread oninside tube 16;Ratio air bag 13 ininside tube 16 is reached more amphi position side place carry out physical grinding and form thezone 37 that is tapered, make assembly thus with structure shown in Fig. 2 (b).

Afterwards; Peri position end withinside tube 16 becomes the mode by the state of outsideamphi position pipe 24 and 23 clampings of outside intervalve; Peri position end, outsideamphi position pipe 24 and outsideintervalve 23 thermosols ofinside tube 16 are applied, and so that the state that is inserted intooutside intervalve 23 in the above-mentioned outsideperi position pipe 22 is fixed both.Then, folding above-mentionedair bag 13 keeps its folding property through heat treatment, obtainsballoon catheter 10 thus.Need to prove that carrying out above-mentioned each thermosol when applying, the suitable internal diameter that uses is fixedly used axle.

Under this situation; Ininside tube 16, be 2mm than the length ofair bag 13 to the zone that the amphi position side is stretched out, the length of the axis direction of the amphi position side standzone 13e ofair bag 13 is 1.5mm; The length of the axis direction of amphi position sideconical region 13d is 9mm; The length of the axis direction ofstraight tube zone 13c is 10mm, and the length of the axis direction of proximal sideconical region 13b is 5mm, and the length of the axis direction of proximalside stent area 13a is 4mm.In addition; Amphi position sideconical region 13d to lean on the wall thickness with the border of amphi position side standzone 13e be 0.06mm; Atair bag 13 is under the situation of swelling state;Straight tube zone 13c is external diameter 1.3mm, internal diameter 1.26mm, is under the situation of contraction state atair bag 13, and the maximum outside diameter that is provided with theseair bag 13 places is 0.7mm.

In addition; The boundary member of 13c and amphi position sideconical region 13d is 2.5mm to the length dimension L2 of the axis direction of the amphi position end of inboardperi position pipe 32 from straight tube zone, and its ratio (L2/L1) with respect to the length dimension L1 of the axis direction of amphi position sideconical region 13d is 0.28.

(embodiment 6～8)

Except using the pipe ofembodiment 2～4 asinside tube 16, other makes theballoon catheter 10 that has structure shown in Fig. 2 (a), (c), (d) respectively withembodiment 5 identically.Under this situation, in embodiment 6, L2 is 4.5mm, and L2/L1 is 0.5.In embodiment 7, L2 is 6.5mm, and L2/L1 is 0.72.In embodiment 8, L2 is 8.5mm, and L2/L1 is 0.94.

(comparative example 1)

Except the amphi position end from the stage portion in the path of inboard peri position pipe zone and zone, big footpath to this inboard peri position pipe (promptly; The peri position end of the joint of inboard peri position pipe and inboard intervalve) length is beyond the 5mm, and other makes inside tube withembodiment 1 identically.In addition, except using this inside tube, other makes balloon catheter withembodiment 5 identically.Under this situation, L2 is 0mm, and L2/L1 is 0.

(evaluation of warp resistance property, lead tracing ability)

Eachballoon catheter 10 to obtaining at the foregoingdescription 5～8 and above-mentioned comparative example 1 utilizes assay device D3 shown in Figure 5 ((strain) メ ジ カ Le セ Application ス system (Business Name), PTCA trainer) to carry out the evaluation of warp resistance property and lead tracing ability for mimic heart coronary artery.

Particularly; Filling to the inside of this assay device D3 under 37 ℃ the state of normal saline; Through the simulation large artery trunks and to insert guiding catheter GC, insert logical 0.014 inch commercially available lead G of external diameter to the inside of guiding catheter GC again in the mode of the intake section configuration leading section of simulating heart coronary artery.Under this state, will be inserted into the simulation heart coronary artery along lead G at eachballoon catheter 10 that the foregoingdescription 5～8 and above-mentioned comparative example 1 obtain.Need to prove, in Fig. 5,, on guiding catheter GC, mark shade for the ease of understanding.

Fig. 6 representes the state after this insertion.The balloon catheter of the above-mentioned comparative example 1 of Fig. 6 (a) expression; Theballoon catheter 10 of Fig. 6 (b) expression the foregoingdescription 5; Theballoon catheter 10 of Fig. 6 (c) expression the foregoing description 6, theballoon catheter 10 of Fig. 6 (d) expression the foregoing description 7, theballoon catheter 10 of Fig. 6 (e) expression the foregoing description 8.In addition, the evaluation result of table 1 expression warp resistance property and lead tracing ability.

[table 1]

	L1(mm)	L2(mm)	L2/L1	Warp resistance property	The leadtracing ability
						Embodiment
5	9	2.5	0.28	Common	Common
						Embodiment 6	9	4.5	0.5	Well	Well
Embodiment 7	9	6.5	0.72	Well	Well
						Embodiment 8	9	8.5	0.94	Well	Common
Comparative example 1	9	0	0	Bad	Bad

Shown in Fig. 6 (a), in comparative example 1, in existence place of amphi position side conical region bending takes place, the lead tracing ability is also poor thereupon.Relative with it, shown in Fig. 6 (b)～(e), inembodiment 5～8, be difficult to take place in the bending of amphi position sideconical region 13d existence place, at embodiment 6～8 this bending does not take place fully especially.In addition, in embodiment 6 and embodiment 7, the lead tracing ability is also good especially.

Claims (6)

1. balloon catheter possesses:

Air bag, it utilizes fluid to expand or shrinks;

Body, it generates the tube chamber that lead is used, and covers the amphi position side by said air bag,

Said balloon catheter is characterised in that,

Said air bag possesses:

Amphi position side engagement zone, it constitutes the joint with respect to the amphi position side of said body;

Expand with the zone, it is projected into outermost part when being formed in said airbag inflation;

Transitional region, it is located at said amphi position side engagement zone and said expansion with between the zone,

Said body possesses:

First pipe;

Second pipe, it is in position and this first pipe joint setting of leaning on proximal side than this first pipe, and rigidity is higher than this first pipe,

This second pipe extends with the mode of leaning on the position of proximal side to get in the space that is surrounded by this transitional region from the boundary member of using zone and said transitional region than said expansion; And the amphi position end that forms said second pipe does not get into the position that is surrounded by said amphi position side engagement zone

Be made as L1, will be made as under the situation of L2 with the boundary member of zone and the said transitional region length dimension to the axis direction of the amphi position end of said second pipe from said expansion at the length dimension with the axis direction of said transitional region, L2/L1 is more than 0.28.

2. balloon catheter as claimed in claim 1 is characterized in that,

Said L2/L1 is below 0.72.

3. according to claim 1 or claim 2 balloon catheter is characterized in that,

Said body possesses tee pipe, and it is in position and this first pipe joint setting of leaning on the amphi position side than said first pipe, and rigidity is lower than this first pipe,

The joint of said first pipe and said tee pipe is present in the position of leaning on the amphi position side than the border in said transitional region and said amphi position side engagement zone on axis direction.

4. balloon catheter as claimed in claim 3 is characterized in that,

The material that forms said first pipe is than the high material of material hardness that forms said tee pipe,

Said first pipe is present in the position of leaning on the amphi position side than said amphi position side engagement zone with the joint of said tee pipe on axis direction, and is the zone of the formation material that comprises said first formation material of managing and said tee pipe,

This regional outer peripheral face is formed by the material that forms of said first pipe, perhaps in forming the material of this regional outer peripheral face, the formation material that contains the said tee pipe of ratio of the said first formation material of managing contain proportional height.

5. balloon catheter possesses:

Air bag, it utilizes fluid to expand or shrinks;

Body, it generates the tube chamber that lead is used, and covers the amphi position side by said air bag,

Said balloon catheter is characterised in that,

Said air bag possesses:

Amphi position side engagement zone, it constitutes the joint with respect to the amphi position side of said body;

Expand with the zone, it is projected into outermost part when being formed in said airbag inflation;

Transitional region, it is located at said amphi position side engagement zone and said expansion with between the zone,

Mensuration load under the enforcement cantilever bending test situation presents the position that exists from the border of the said amphi position side engagement zone of air bag described in the said body and said transitional region and begins more towards the big more tendency of proximal side; And get into the position of 5/6 distance measurements of the axis direction length dimension of the said transitional region of proximal side in the position that exists from said border; Said mensuration load is more than the 1gf; Said cantilever test makes the said supporting station 1mm of the distance place of this body pass through probe to bottom offset 0.5mm for the amphi position side is stretched out body under the state that level keeps on the support platform.

6. balloon catheter as claimed in claim 5 is characterized in that,

The position of border existence that said mensuration loads on said amphi position side engagement zone and the said transitional region of air bag described in the said body is below the 1.1gf.

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