CN103052422A - Dilatation Catheter - Google Patents

Dilatation Catheter Download PDF

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Publication number
CN103052422A
CN103052422A CN2010800683910A CN201080068391A CN103052422A CN 103052422 A CN103052422 A CN 103052422A CN 2010800683910 A CN2010800683910 A CN 2010800683910A CN 201080068391 A CN201080068391 A CN 201080068391A CN 103052422 A CN103052422 A CN 103052422A
Authority
CN
China
Prior art keywords
installation site
catheter
installing component
sacculus
dilating catheter
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN2010800683910A
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Chinese (zh)
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CN103052422B (en
Inventor
岩野健志
三宅孝政
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Goodman Co Ltd
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Goodman Co Ltd
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Publication date
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Publication of CN103052422A publication Critical patent/CN103052422A/en
Application granted granted Critical
Publication of CN103052422B publication Critical patent/CN103052422B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1081Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1093Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1006Balloons formed between concentric tubes

Abstract

Provided is a technology for suppressing the trapping of an elongated element included in a balloon catheter. The present invention provides a dilatation catheter. This dilatation catheter (10) comprises: catheter shafts (15, 16); a dilatation element (13) connected to one end of the catheter shaft and having a dilatation area to be dilated in the diametrical direction; and an elongated element (31) arranged along the outer circumferential surface of the dilatation area and deforming outward along with the dilatation of the dilatation area by being mounted on the catheter shafts (15, 16) at a first mounting position and a second mounting position across the dilatation area. The dilatation catheter is characterized in that a specific mounting position (45b, 71) that is at least one of the first and second mounting positions is movable relative to the catheter shafts (15, 16), and that the movement of the specific mounting position is restricted in the restricting direction that is at least one direction.

Description

Dilating catheter
Technical field
The present invention relates to a kind of foley's tube, when the dilation therapy of the narrow positions of carrying out blood vessel or block part etc., this foley's tube inserts in organism and uses.
Background technology
In the past, in the treatment of carrying out PTCA (percutaneous transluminal coronary angioplasty) and so on, used foley's tube.The scheme of elongated member is also proposed to have around sacculus for foley's tube.For example, in the foley's tube shown in the patent documentation 1, be provided with elongated member at the outer circumferential side of sacculus in the mode of striding along its length this sacculus.Elongated member can be followed the expansion of sacculus and interlock pathological changes section, thereby forms the lumen (stream) of axis direction in pathological changes section.Elongated member also has the effect that can suppress the slip between sacculus and the pathological changes section.
On the other hand, the present application people finds that there is following problem in elongated member, that is, when wish is chosen foley's tube in the body when sacculus is shunk, the problem that foley's tube is difficult to choose by pathological changes section (such as the calcification pathological changes) or the cards such as the support extension kept somewhere.It is a kind of by an end that the makes elongated member technology that the card of eliminating elongated member hangs that comes off that the present application people provides in patent documentation 2.
[formerly technical literature]
[patent documentation]
[patent documentation 1] Japanese Unexamined Patent Application Publication 2005-517474 communique
[patent documentation 2] TOHKEMY 2009-112361 communique
[patent documentation 3] TOHKEMY 2008-206702 communique
[patent documentation 4] Japanese Unexamined Patent Application Publication 2007-530158 communique
[patent documentation 5] Japanese kokai publication hei 10-137257 communique
But the present application people not only hangs the card of eliminating elongated member and studies, but also has carried out wholwe-hearted research to suppressing card extension itself.
Summary of the invention
The present invention makes at least a portion that solves above-mentioned in the past problem, and its purpose is to provide a kind of technology that suppresses the card extension of elongated member in having the foley's tube of elongated member.
Below, when being shown as required, effect, effect describe solving the effective device of above-mentioned problem.
Device 1. comprises:
Catheter shaft;
Expansion member, the end that it is located at described catheter shaft has the extended region of the expansion of direction laterally;
Elongated member, it is along the configuration of outer peripheral face of described extended region, strides described extended region and is installed on described catheter shaft in the first installation site and the second installation site, follows thus described expansion regions extension of a field and Direction distortion laterally,
Specific installation site as at least one party of described the first installation site and described the second installation site can be moved with respect to described catheter shaft,
The movement of described specific installation site is being restricted for the restriction direction of at least one direction.
In device 1, because the first installation site of elongated member and at least one party of the second installation site can move with respect to catheter shaft, therefore, the deflection of the elongated member the when extended region that can reduce the length because of elongated member has residue to cause shrinks.On the support of pathological changes section (for example calcification pathological changes) or indwelling, block the main cause of hanging because the deflection of elongated member is elongated member, therefore, by reducing this deflection, can suppress the card of elongated member and hang.And then can reduce drawing the time and the friction of blood vessel.
The deflection of elongated member is owing to the length of elongated member when extended region shrinks has residue to produce with respect to the distance between the first installation site and the second installation site.This is because when extended region expands, the Distance Shortened between the first installation site and the second installation site.The Distance Shortened of the first installation site and the second installation site is mainly caused by the permanent deformation that the axial length of expansion member produces when expansion member is expanded.
But, according to device 1, even the length of elongated member has residue, because at least one party of the first installation site and the second installation site can move with respect to catheter shaft, therefore, can suppress the deflection of elongated member by absorbing this remaining length.On the other hand, because the movement of specific installation site is for the restriction direction of at least one direction is restricted, so can has and for example prevent the effect that comes off.
Need to prove that " elongated member " is not limited to have the parts of the function of the Non-slip material that conduct is slided for the inhibition expansion member with the interlock of pathological changes section when expansion member (for example sacculus) is expanded.For example, also can have at least a in the following various function, described various functions are: when expansion member is expanded as the function of the cutting edge that is used for cutting pathological changes section, function that the pathological changes of nipping section forms lumen, as the function that is used for confirming in vitro the radiography body of sacculus position in vivo.In addition, so-called lateral direction for example comprises on diametric(al) the direction away from the central shaft of catheter shaft.
In addition, in the treatment target of the long extended region of needs, correspondingly elongated member is also long, and bending deformation is large, and therefore, this device that can reduce deflection can have significant effect.Particularly, for example in the treatment coronarius of brain or heart, can utilize relatively shorter extended region to tackle, but in the treatment of the peripheral vessel at such other positions of human body of for example huckle blood vessel, need long extended region, therefore, this device can have significant effect.
Need to prove, in the treatment coronarius of brain or heart, the diameter of expansion member and length generally be respectively 2 to 4mm and 13mm about.On the other hand, in the treatment of the peripheral vessel at other positions of human body, the diameter of expansion member and length generally are respectively about 4 to 8mm and 20 to 40mm.
Device 2. is according to device 1 described dilating catheter, and described elongated member has elastomeric element, and this elastomeric element has for the restoring force from described deformation-recovery,
The action of following answer of the described elongated member when described specific installation site can be shunk along with described extended region and moving.
In device 2, the answer of the elongated member in the time of can shrinking along with extended region owing to the installation site of elongated member action is moved, and therefore, after the extended region contraction, can suppress to only have elongated member to become the situation of the state that deflection broadens.The card that thus, can suppress the elongated member of the state that deflection broadens is hung.
Device 3. is according to device 1 or 2 described dilating catheters, the mobile installing component that described dilating catheter also possesses a plurality of described elongated members and can move with respect to described catheter shaft,
Described a plurality of elongated member all has described specific installation site at described mobile installing component.
Install 3 owing to can a plurality of elongated members being installed with respect to the mobile installing component that catheter shaft moves, therefore, can the whole deflection that reduces a plurality of elongated members.Thus, can reduce smoothly the deflection of a plurality of elongated members.
Device 4. is according to device 3 described dilating catheters, and described dilating catheter also has the limiting part in the movement of the described mobile installing component of described restriction direction restriction,
Described limiting part is configured between described the first installation site and described the second installation site.
In device 4, because the limiting part that moves of moving-limiting installing component is configured between the first installation site and the second installation site, therefore, can prevent from reliably being installed in the first installation site and the second installation site the coming off of fine rule element of catheter shaft.
Device 5. is according to device 4 described dilating catheters, and described limiting part is configured between the link position of described mobile installation portion and described expansion member between described the first installation site and described the second installation site.
In device 5, owing to limiting part is configured between the link position of mobile installation portion and expansion member, therefore, the link position of limiting part, mobile installation portion and the expansion member of can mutually staggering.Thus, can prevent the such state of affairs of the local hardening of the overlapping dilating catheter that causes because of the link position of limiting part, mobile installation portion and expansion member, so can suppress the reduction of the bending resistance folding endurance (Application of anti-キ Network) that causes because of equipment limiting part etc.
In addition, when the drawing dilating catheter, because limiting part can be scattered in the drawing load catheter shaft and elongated member, catheter shaft loses in the time of therefore also can helping to prevent drawing.In addition, even owing to bend or lose in the generation of the link position place of expansion member, also can pull expansion member by elongated member, so also have the fail safe that can prevent coming off of expansion member such.
Device 6. is according to device 4 or 5 described dilating catheters, described dilating catheter has a plurality of elongated members, and described a plurality of elongated members are connected in described mobile installing component with respect to described mobile installing component interval with approximate equality on the circumference centered by the central axis of described catheter shaft.
In device 6, because a plurality of elongated members are connected in mobile installing component with respect to mobile installing component with the interval of approximate equality, therefore, the interval from a plurality of elongated members to mobile installing component with approximate equality applies load.Thus, can make the movement of mobile installing component smooth and easy.
Device 7. is according to each described dilating catheter in the device 4 to 6, and described dilating catheter also possesses force application part, the moving direction application of force of the described mobile installing component when this force application part is replied to described elongated member described mobile installing component.
In device 7, owing to have the force application part of the moving direction application of force of the mobile installing component when replying to elongated member, therefore, can also make the answer (reduction of deflection) of elongated member smooth and easy and reduce deflection.
Device 8. is according to device 7 described dilating catheters, and described force application part is disposed between described limiting part and the described mobile installing component.
In device 8, because force application part is between limiting part and mobile installing component, therefore, by force application spring or have this simple structure of elastic pipe and just force application part can be installed, and then can effectively prevent coming off of force application part.
Device 9. is according to each described dilating catheter in the device 1 to 8, the action of the Accompanying Deformation of the described elongated member when expand with respect to described extended region in described specific installation site and be limited mobile.
In device 9, because the action of the Accompanying Deformation of the elongated member of specific installation site when expanding with respect to extended region is limited movement, therefore, elongated member excessive deformation in the time of can avoiding the extended region expansion and leave the state of affairs of extended region.
Device 10. is according to each described dilating catheter in the device 1 to 9, and described catheter shaft is formed with the inner chamber for fluid flow,
Described expansion member has the extended region that forms the space be communicated with described inner chamber, and constitutes under the effect of the pressure of described fluid and expand.
In device 10, because expansion member has the extended region that forms the space be communicated with the inner chamber of fluid flow, and constitute under the effect of the pressure of this fluid and expand, so can realize simply expansion under the heavy load.
Device 11. is according to each described dilating catheter in the device 1 to 10, described dilating catheter also possesses the elastic mounting part that is formed with the elasticity installation site, this elasticity installation site is the installation site of non-described specific installation site one side in described the first installation site and described the second installation site
In described elastic mounting part, elongation by described elastic mounting part when described expansion member expansion makes described elasticity installation site near described specific installation site, and the contraction by described elastic mounting part makes described elasticity installation site away from described specific installation site when described expansion member is shunk.
In device 11, when expansion member is shunk because elastic mounting part pulls elongated member from the opposition side of specific installation site, therefore can establishment in the deflection of the opposition side generation of specific installation site.
Description of drawings
Fig. 1 is the concise and to the point unitary side view of structure that the foley's tube of the first embodiment is shown.
Fig. 2 (a) illustrates the sacculus of contraction state and the concise and to the point side view of peripheral structure thereof, and Fig. 2 (b) is the sectional elevation of Fig. 2 (a).
Fig. 3 (a) illustrates the sacculus of swelling state and the concise and to the point side view of peripheral structure thereof, and Fig. 3 (b) is the sectional elevation of Fig. 3 (a).
Fig. 4 (a) is the longitudinal section of Fig. 2 (a), (b) is the longitudinal section of Fig. 3 (a).
Fig. 5 illustrates the sacculus of the contraction done state after the expansion and the longitudinal section of peripheral structure thereof.
Fig. 6 is illustrated in the longitudinal section that produces gap delta between thread-like member and the sacculus.
Fig. 7 is the longitudinal section of the foley's tube of the second embodiment.
Symbol description
10,10a ... foley's tube, 11 ... conduit is with managing 12 ... lining, 13 ... sacculus, 15 ... outboard tube, 15a ... inner chamber, 16 ... inside tube, 16a ... balloon-markers, 21 ... the peri position end, 22 ... the distolateral conical region of peri position, 22 ... expansion area, 23 ... the straight tube zone, 23 ... expansion area, 24 ... the distolateral conical region of amphi position, 24 ... expansion area, 25 ... the amphi position end, 26 ... blade, 31 ... thread-like member, 32 ... the peri position end, 33 ... the amphi position end, 45 ... fixing umbrella section, 45a ... the front installing hole, 45b ... the base end side installing hole, 71 ... mobile installing component, 79 ... force application spring, 81 ... retainer.
The specific embodiment
(the first embodiment)
Below, first embodiment that the present invention has been specialized is described with reference to the accompanying drawings.Fig. 1 is the concise and to the point unitary side view of foley's tube 10.
As shown in Figure 1, foley's tube 10 has: conduit with pipe (catheter shaft) 11, be installed on conduit with the lining 12 of pipe 11 peri position end (base end part), be installed on conduit with the sacculus 13 of managing 11 amphi position end (leading section).
Conduit is made of a plurality of pipes (tubular shafts) with pipe 11, and the position from the half-way of length direction (axially) to sacculus 13 is inside and outside multitube structure (inside and outside dual tubular construction) at least.Specifically, conduit has outboard tube (outboard tube) 15 and internal diameter and the external diameter inside tube (inside tube) 16 less than this outboard tube 15 with pipe 11, by in outboard tube 15 interior insertion inside tube 16, thereby consist of above-mentioned inside and outside the multitube structure.
At this, above-mentioned outboard tube 15 and inside tube 16 by polyamide-based resin formation to have the pliability of regulation.But, as long as have pliability, be not limited to polyamide-based resin, can use polyethylene-based resin, polypropylene-based resin, polyurethane series resin, polyimides is the synthetic resin materials such as resin, also can take above-mentioned each synthetic resin material as base material to this base material in additive package.In addition, also can form with different synthetic resin material outboard tube 15 and inside tube 16.
Inside tube 16 is compared with outboard tube 15 to the distolateral prolongation setting of amphi position, is provided with sacculus 13 in the zone of the prolongation of this inside tube 16 and the amphi position end of outboard tube 15.
Below, describe sacculus 13 and peripheral structure thereof in detail with reference to Fig. 2~Fig. 4.Fig. 2 (a) is the sacculus 13 of contraction state and the concise and to the point side view of peripheral structure thereof, and Fig. 2 (b) is the sectional elevation of Fig. 2 (a).Fig. 3 (a) is the sacculus 13 of swelling state and the concise and to the point side view of peripheral structure thereof, and Fig. 3 (b) is the sectional elevation of Fig. 3 (a).In addition, Fig. 4 (a) is the longitudinal section of Fig. 2 (a), and Fig. 4 (b) is the longitudinal section of Fig. 3 (a).
Sacculus 13 is by polyamide-based resin formation.But, as long as have pliability, be not limited to polyamide-based resin, also can use polyethylene-based resin, polypropylene-based resin, polyurethane series resin, polyimides is resin, silicone rubber, natural rubber etc.
Sacculus 13 has peri position end 21, the distolateral conical region 22 of peri position, straight tube zone 23, the distolateral conical region 24 of amphi position and amphi position end 25 as shown in Figures 3 and 4.Under swelling state, distolateral conical region 24 these Three regions of the distolateral conical region 22 of peri position, straight tube zone 23 and amphi position expand.Above-mentioned zone is also referred to as expansion area 22,23,24.
Sacculus 13 as shown in Figure 4, peri position end 21 engages with outboard tube 15, amphi position end 25 engages with inside tube 16.Sacculus 13 between above-mentioned both ends from the outer peripheral face of outer side covers outboard tube 15 and inside tube 16.The inner chamber 15a of outboard tube 15 consists of the compressed fluid that will supply with from lining 12 to the fluid stream of the inside guiding of sacculus 13.Form the inner chamber (with reference to Fig. 2 (b)) of the guiding path of using as seal wire in inside tube 16.
Sacculus 13 applies by hot melt and engages with outboard tube 15 and inside tube 16.But, joint method is not limited to this, also can use bonding agent etc. to engage.For sacculus 13, can utilize X ray from the position of exterior monitoring sacculus 13.This is because in the inside of sacculus 13, has two balloon-markers 16a that do not see through X ray to be installed on the inside tube 16.
Sacculus 13 has following shape under swelling state.Sacculus 13 has the outer shape in the stepped variation of a plurality of position cross sectional shape.Peri position end 21 is the parts that engage with outboard tube 15.The distolateral conical region 22 of peri position is that an end is connected with peri position end 21, the other end and 23 zones that are connected, straight tube zone.The distolateral conical region 22 of peri position has from peri position end 21 towards straight tube zone 23 continuously and is linearly that diameter becomes large cone shape.The distolateral conical region 24 of amphi position is that an end is connected the zone that the other end is connected with amphi position end 25 with straight tube zone 23.The distolateral conical region 24 of amphi position has from straight tube zone 23 towards the amphi position end 25 continuously and is the cone shape that diameter linearly diminishes.Amphi position end 25 is the parts that engage with inside tube 16.
As shown in Figure 2, sacculus 13 has following shape under contraction state.Sacculus 13 is Multi-vane type and forming as the form with a plurality of blades 26.In the present embodiment, the quantity of blade 26 is 3, is called as 3 vane types.3 blades 26 fold to form the mode of 3 blades 26 under contraction state.Each sheet of 3 blades 26 forms the state on every side that is wrapped in inside tube 16.Blade 26 is also referred to as flap or assistant.
Each sheet of 3 blades 26 folds uniformly-spaced to form a plurality of modes as the blade 26 that the expansion area of sacculus 13 vertically erects along its length.Between each sheet of 3 blades 26, dispose 3 thread-like member 31 along expansion area 22,23,24 outer surface.Thread-like member 31 is also referred to as linear device or elongated member.
Thread-like member 31 has following structure.
Thread-like member 31 is so that thread-like member 31 has the form ground that suitable rigidity and flexual mode present silk thread or monofilament forms.Thread-like member 31 has the elastomeric character that has restoring force with respect to flexural deformation.As the material that forms thread-like member 31, particularly by polyamide-based resin formation.Need to prove, as long as have suitable rigidity, pliability and elasticity, then be not limited to polyamide-based resin, also can use other synthetic resin.In addition, also can be not limited to synthetic resin and use rustless steel, Ni-Ti alloy or carbon fibre.Thread-like member 31 is provided with a plurality of.
Each thread-like member 31 is following state, that is, its cross section forms triangle, under the swelling state of sacculus 13, one side of the above-mentioned triangle of each thread-like member 31 is positioned on the outer peripheral face of sacculus 13, and an angle of above-mentioned triangle is outstanding laterally from the outer peripheral face of sacculus 13.Need to prove that the cross section of each thread-like member 31 needn't be triangle.As long as the antiskid function in the time of can playing sacculus 13 expansion described later, the cross section of each thread-like member 31 also can be circular, can also be tetragons.
The amphi position end 33 of thread-like member 31 (stiff end of leading section side) is installed on inside tube 16 as described below.Thread-like member 31 is installed on inside tube 16 by fixing umbrella section 45.Fixedly umbrella section 45 forms as base material by having elastic polyamide-based elastomer.Fixedly umbrella section 45 is in that fixedly leading section side and the base end part side of umbrella section 45 are formed with respectively front installing hole 45a and base end side installing hole 45b.At front installing hole 45a, fixedly umbrella section 45 applies by hot melt and is fixed in the inside tube 16 that polyamide-based resin is formed as base material.At base end side installing hole 45b, fixedly the amphi position end 33 of being fixed in by the thread-like member 31 of polyamide-based resin formation is applied by bonding or hot melt by umbrella section 45.
Fixedly umbrella section 45 has the interior shape that internal diameter enlarges towards base end side installing hole 45b from front installing hole 45a.Utilize this shape, base end side installing hole 45b can separate along diametric(al) from the outer peripheral face of inside tube 16, therefore, can carry out base end side installing hole 45b relatively moving with respect to inside tube 16 by the fixing strain of umbrella section 45.
For fixing umbrella section 45, when sacculus 13 expands, make base end side installing hole 45b near thread-like member 31 another distolateral (mobile installing component 71) by the fixing extension of umbrella section 45, when sacculus 13 shrinks, make base end side installing hole 45b away from mobile installing component 71 by the fixing contraction of umbrella section 45.Thus, when sacculus 13 shrank, base end side installing hole 45b can pull thread-like member 31 from the opposition side of mobile installing component 71, therefore, and the deflection that can establishment produces at the opposition side of mobile installing component 71.Need to prove that fixedly umbrella section 45 and base end side installing hole 45b also are hereinafter referred to as elastic mounting part and elasticity installation site.
The peri position end 32 of thread-like member 31 is installed on outboard tube 15 as described below.The peri position end 32 of thread-like member 31 is installed on outboard tube 15 by mobile installing component 71.Mobile installing component 71 is resin formation by amide similarly with thread-like member 31.Mobile installing component 71 has cylindrical shape, and the internal diameter of this cylindrical shape is greater than the profile of outboard tube 15, the profile of the blade 26 of the sacculus 13 of its external diameter when shrinking.
3 thread-like member 31 all are installed on mobile installing component 71.In the installation of carrying out to mobile installing component 71, the interval with approximate equality on the circumference centered by the central axis of outboard tube 15 connects.Thus, can apply with the interval of approximate equality the load from thread-like member 31, therefore, mobile installing component 71 can move (slip) along its axis direction swimmingly with respect to outboard tube 15.Need to prove that the two ends of thread-like member 31 are also referred to as the first installation site and the second installation site.
Mobile installing component 71 is compared with the retainer 81 that is fixed in outboard tube 15 and is installed on peri position end side (lining 12 sides).Retainer 81 is resin formation by amide similarly with thread-like member 31, applies by hot melt and is fixed in outboard tube 15.Thus, the forward distolateral movement of mobile installing component 71 (to the movement of restriction direction) is stopped part 81 restrictions, but can be mobile swimmingly to retainer 81.Need to prove that retainer 81 is also referred to as limiting part.
Retainer 81 is fixed on sacculus 13 position that expansion is front with mobile installing component 71 contacts.Such fixed position is used for suppressing the generation of all gap delta as shown in Figure 6.Gap delta is because following former thereby produce, that is, because the tension force of thread-like member 31 is insufficient, so under the effect of the flexural rigidity of thread-like member 31, thread-like member 31 becomes level and smooth shape and not along the outer shape of sacculus 13.The generation of this gap delta becomes the reason that thread-like member 31 is avoided (dislocation) when especially hardening in pathological changes section, therefore, as the sufficient condition of the tension force that makes thread-like member 31, requires to reduce or eliminate gap delta.
Retainer 81 is arranged between peri position end 21 and the mobile installing component 71.Such configuration can make retainer 81, mobile installing component 71 and peri position end 21 (link position of sacculus 13 and outboard tube 15) mutually stagger.That is, retainer 81, mobile installing component 71 and peri position end 21 can dispose in mutual nonoverlapping mode.Thus, can prevent the situation owing to the overlapping foley's tube that the causes 10 local hardening of above-mentioned parts, so can suppress the reduction of the bending resistance folding endurance that the outfit because of retainer 81 and mobile installing component 71 causes.
When drawing foley's tube 10, retainer 81 can be scattered in thread-like member 31 and outboard tube 15 with the drawing load by mobile installing component 71, therefore, and the losing of outboard tube 15 (especially preventing from losing in peri position end 21) when also being conducive to prevent drawing.And then, also have fail safe, that is, even supposition break in peri position end 21, owing to coming drawing sacculus 13 by thread-like member 31, so also can prevent coming off of sacculus 13.
Thread-like member 31 only by fixedly umbrella section 45 and mobile installing component 71 are fixing, is not fixed with respect to sacculus 13 fully.Thus, compare in the structure of whole length direction upper fixed line shape parts 31 with the expansion area with respect to sacculus 13, can in the situation of the flexibility of as far as possible not damaging sacculus 13, thread-like member 31 be set.
At the outer circumferential side of sacculus 13, along (configuration) circumferentially uniformly-spaced is installed 3 thread-like member 31 are arranged.Particularly, thread-like member 31 with the blade 26 of sacculus 13 one to one mode be provided with 3, each thread-like member 31 at the outer circumferential side of sacculus 13 along circumferentially being installed in mobile installing component 71 with 120 ° interval and fixedly in the umbrella section 45.
The length dimension of thread-like member 31 is set to the length ruler modest ability than the length direction of sacculus 13.Thread-like member 31 at the outer circumferential side of sacculus 13, is arranged to stride along its length at least expansion area 22,23,24 of sacculus 13 with the state that two ends only are installed shown in Fig. 4 waits.The middle part of each thread-like member 31 is positioned on the outer peripheral face of sacculus 13.
Thread-like member 31 is shown in Fig. 2 (b), and under the contraction state of sacculus 13, each thread-like member 31 is configured in the root side of corresponding blade 26.On the other hand, thread-like member 31 is under the swelling state of sacculus 13, and shown in Fig. 3 (b), each thread-like member 31 follows the expansion of sacculus 13 and becomes with the overlapping position of each blade 26 to radial outside displacement and the state that protrudes.Each thread-like member 31 is in that to relate to fixing structure aspects identical.But, the hot melt that fixedly is not limited to of thread-like member 31 applies, and also can use bonding agent to be fixed.
The thread-like member 31 of foley's tube 10 with said structure is following the action in the expansion of sacculus 13 with in shrinking.In the expansion process of sacculus 13,3 thread-like member 31 along with the expansion of sacculus 13 to the Direction distortion that leaves inside tube 16.Thus, the thread-like member 31 with triangular cross-sectional shape is nipped the pathological changes section of blood vessel (omitting diagram) and is difficult for sliding, and sacculus 13 begins to expand pathological changes section from the inboard simultaneously.
On the other hand, with the distortion of thread-like member 31 accordingly, fixedly umbrella section 45 extends by strain, base end side installing hole 45b moves to the peri position end side.This is because mobile installing component 71 is stopped part 81 restriction forward end side shiftings.Thus, base end side installing hole 45b can be near mobile installing component 71, so thread-like member 31 can be out of shape along with the expansion of sacculus 13.
In the contraction process of sacculus 13,3 thread-like member 31 along with the contraction of sacculus 13 to the Direction distortion near inside tube 16 sides.This distortion is undertaken by the fixing restoring force of umbrella section 45 and thread-like member 31.But the present application people finds, after sacculus 13 expands, mainly produces sacculus 13 axial shortening and the fixing permanent deformation of the elongation of umbrella section 45 when folding, under the effect of these remnants, becomes the state of 3 thread-like member 31 deflections.This permanent deformation all is that the overstrain when expanding owing to sacculus 13 produces.
The present application people finds that this deflection produces by following mechanism.Axial shortening when sacculus 13 folds makes retainer 81 to amphi position end side shifting.On the other hand, fixedly the elongation of umbrella section 45 makes the amphi position end 33 of thread-like member 31 move to the peri position end side.Thus, if be the mobile structure of mobile installing component 71, namely for example be that the amphi position end 33 of thread-like member 31 is fixed on the structure on the retainer 81, then can produce deflection as in the past.
Fig. 5 illustrates sacculus 13 under the expansion after-contraction done state and the longitudinal section of peripheral structure thereof.As shown in Figure 5, because being absorbed, residue length as the gap R between mobile installing component 71 and the retainer 81, therefore can reduce the deflection that is caused by residue length.
According to the present embodiment of above detailed description, has following good result.
When sacculus 13 expands, thereby thread-like member 31 can be out of shape along the outer shape of sacculus 13 by the tension force that the fixing strain of umbrella section 45 is born appropriateness.On the other hand, when sacculus 13 shrank, under the effect of the fixing restoring force of umbrella section 45 and thread-like member 31, the deflection of thread-like member 31 was eliminated.In addition, because an end of thread-like member 31 can move to the direction of elongating thread-like member 31 with respect to outboard tube 15, therefore can prevent the deflection that the length because of thread-like member 31 has residue to cause.Thus, can suppress thread-like member 31 and hang to pathological changes section (for example calcification pathological changes) or the bracket clamp kept somewhere, and can reduce drawing the time and the friction of blood vessel.
(the second embodiment)
Fig. 7 is the cutaway view that the foley's tube 10a of the second embodiment is shown.Foley's tube 10a is equipped with force application spring 79 between retainer 81 and mobile installing component 71, this point is different from the first embodiment.When force application spring 79 shrinks at sacculus 13, can absorb by active force the residue length of thread-like member 31, thereby can further reduce the deflection of thread-like member 31.
Force application spring 79 not only can be metal helical spring shown in Figure 7, also can be for example to have the resin component element with spring function that elastic polyamide-based elastomer forms as base material.Need to prove that force application spring 79 is also referred to as force application part.
For example when the flexural rigidity of thread-like member 31 little and when being difficult to expectation restoring force being arranged, perhaps when when tackling the long setting sacculus 13 of long-term pathological changes, the second embodiment has significant effect.This is that correspondingly elongated member is also long because in the treatment target of the long extended region of needs, thereby bending deformation is large.Particularly, for example in the treatment coronarius of brain or heart, can utilize relatively shorter extended region to tackle, but in the treatment of the peripheral vessel at such other positions of human body of for example huckle blood vessel, need long extended region, therefore, this device can have significant effect.
Need to prove, in the treatment coronarius of brain or heart, the diameter of expansion member and length generally be respectively 2 to 4mm and 13mm about.And in the treatment of the peripheral vessel at other positions of human body, the diameter of expansion member and length generally are respectively about 4 to 8mm and 20 to 40mm.
(other embodiments)
The invention is not restricted to the content of the respective embodiments described above record, for example also can followingly carry out.
(1) in the respective embodiments described above, the thread-like member 31 of the slip when being provided with for 13 expansion of inhibition sacculus as elongated member, but the thread-like member of also can setting example using such as the cutting edge that is used for cutting pathological changes section when sacculus 13 expands can also be used banded elongated member.
(2) in the respective embodiments described above, use to have elastic fixedly umbrella section 45, be installed in the parts that form on the inside tube but also can use by material non-resilient or that elasticity is minimum.But, use the generation with elastic fixedly umbrella section 45 gap delta (with reference to Fig. 6) can effectively reduce sacculus 13 and expand the time.Especially in the structure of not using force application spring, can obtain significant effect.But, use and to have elastic fixedly umbrella section 45 and force application spring multiple design freedom in being set in of the initial load that comprises force application spring can be provided.
(3) in the respective embodiments described above, be provided with mobile installing component in the peri position end side, but also can mobile installing component be set in the amphi position end side.For the present invention, as long as at least one in the installation site at the two ends of elongated member is that specific installation site can be moved with respect to catheter shaft.The movement of specific installation site is limited as long as namely limit direction at least one direction.The restriction of the movement of specific installation site is not limited to make shown in above-mentioned embodiment the movement towards a direction (amphi position is distolateral) to stop fully, for example also can fixed width be set and carry out two-way restriction.
(4) in the respective embodiments described above, elongated member is towards the linearly formation in its two ends, but also can have for example spiral helicine structure.Like this because when expanding and when contraction move installing component and rotate with respect to outboard tube, therefore can make mobile installing component smooth and easy with respect to the slip of outboard tube.
(5) in the respective embodiments described above, apply the present invention to use in the foley's tube of the sacculus that under fluid pressure, expands, also can in for example utilizing the mechanism of mechanical type expansion, have and make the zone that is equivalent to above-mentioned expansion area along the mechanism in the zone of radial direction expansion.Need to prove that it must be dual conduits structure that catheter shaft does not need, get final product so long as have flexual catheter shaft solid or hollow.The present invention can be applied to use the dilating catheter of expansion member, and described expansion member generally is connected with an end of catheter shaft, and has the extended region of laterally direction expansion.In addition, so-called lateral direction for example comprises on diametric(al) the direction away from the central shaft of catheter shaft.
(6) in the respective embodiments described above, do not set the disengaging pattern that thread-like member 31 breaks away from from dilating catheter, but the amphi position end 33 that for example can be set as thread-like member 31 breaks away from easily than the installation to mobile installing component 71 of the peri position end 32 of thread-like member 31 to the installation of fixing umbrella section 45.Like this, even hang on in-vivo tissue or the support because certain reason makes thread-like member 31 card, also can in the situation of excessive damage in-vivo tissue not, extract swimmingly conduit.
(7) in the respective embodiments described above, constitute and utilize retainer 81 that mobile installing component 71 is not come off from dilating catheter, but for example also can omit retainer 81 equipment but in the peri position end 21 of sacculus 13 or the movement of the distolateral conical region 22 moving-limiting installing components 71 of peri position.And then, can the position of retainer 81 equipment by X ray not the X ray that consists of of permeable material do not see through labelling, and it is brought into play function as the mobile restriction parts.

Claims (11)

1. dilating catheter is characterized in that possessing:
Catheter shaft;
Expansion member, the end that it is located at described catheter shaft has the extended region of the expansion of direction laterally;
Elongated member, it is along the configuration of outer peripheral face of described extended region, strides described extended region and is installed on described catheter shaft in the first installation site and the second installation site, follows thus described expansion regions extension of a field and Direction distortion laterally,
Specific installation site as at least one party of described the first installation site and described the second installation site can be moved with respect to described catheter shaft,
The movement of described specific installation site is being restricted for the restriction direction of at least one direction.
2. dilating catheter according to claim 1 is characterized in that,
Described elongated member has elastomeric element, and this elastomeric element has for the restoring force from described deformation-recovery,
The action of following answer of the described elongated member when described specific installation site can be shunk along with described extended region and moving.
3. dilating catheter according to claim 1 and 2 is characterized in that,
The mobile installing component that described dilating catheter also possesses a plurality of described elongated members and can move with respect to described catheter shaft,
Described a plurality of elongated member all has described specific installation site at described mobile installing component.
4. dilating catheter according to claim 3 is characterized in that,
Described dilating catheter also has the limiting part in the movement of the described mobile installing component of described restriction direction restriction,
Described limiting part is configured between described the first installation site and described the second installation site.
5. dilating catheter according to claim 4 is characterized in that,
Described limiting part is configured between the link position of described mobile installation portion and described expansion member between described the first installation site and described the second installation site.
6. according to claim 4 or 5 described dilating catheters, it is characterized in that,
Described dilating catheter has a plurality of elongated members,
Described a plurality of elongated member is connected in described mobile installing component with respect to described mobile installing component interval with approximate equality on the circumference centered by the central axis of described catheter shaft.
7. each described dilating catheter in 6 according to claim 4 is characterized in that,
Described dilating catheter also possesses force application part, the moving direction application of force of the described mobile installing component when this force application part is replied to described elongated member described mobile installing component.
8. dilating catheter according to claim 7 is characterized in that,
Described force application part is disposed between described limiting part and the described mobile installing component.
9. each described dilating catheter in 8 according to claim 1 is characterized in that,
The action of the Accompanying Deformation of the described elongated member when expand with respect to described extended region in described specific installation site and be limited mobile.
10. each described dilating catheter in 9 according to claim 1 is characterized in that,
Described catheter shaft is formed with the inner chamber for fluid flow,
Described expansion member has the extended region that forms the space be communicated with described inner chamber, and constitutes under the effect of the pressure of described fluid and expand.
11. each described dilating catheter in 10 is characterized in that according to claim 1,
Described dilating catheter also possesses the elastic mounting part that is formed with the elasticity installation site, and this elasticity installation site is the installation site of non-described specific installation site one side in described the first installation site and described the second installation site,
In described elastic mounting part, elongation by described elastic mounting part when described expansion member expansion makes described elasticity installation site near described specific installation site, and the contraction by described elastic mounting part makes described elasticity installation site away from described specific installation site when described expansion member is shunk.
CN201080068391.0A 2010-08-30 2010-08-30 Dilatation Catheter Active CN103052422B (en)

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