CN103252014B - Medical device - Google Patents

Medical device Download PDF

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Publication number
CN103252014B
CN103252014B CN201210038063.7A CN201210038063A CN103252014B CN 103252014 B CN103252014 B CN 103252014B CN 201210038063 A CN201210038063 A CN 201210038063A CN 103252014 B CN103252014 B CN 103252014B
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China
Prior art keywords
intensive aspect
layer
region
friction
coiled material
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CN201210038063.7A
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Chinese (zh)
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CN103252014A (en
Inventor
井泽圭
藤原达道
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Goodman Co Ltd
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Goodman Co Ltd
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Priority to CN201210038063.7A priority Critical patent/CN103252014B/en
Publication of CN103252014A publication Critical patent/CN103252014A/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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • 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
    • A61M2025/0004Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system

Abstract

The present invention provides a kind of part in inserting organism to utilize in the structure in metal tubulation portion, it is possible to realize the medical device of the raising of resistance to bend(ing) well.Outer tube part (31) is by being embedded in resin bed (41) by metal joint ring (42) and metal reinforcement coiled material (43) and formed.Reinforcement coiled material (43) is by making the metal wire of stainless steel surround into helical form, and is formed as the coiled type that axis direction is length direction, and rigidity is set to lower than engaging ring (42).Reinforcement coiled material (43) by peri position end be present in the position of outward opening (34) and distal end section be present in than engage ring (42) by amphi position side in the way of extend, arranging the most on the whole of outer tube part (31).In the structure shown here, strengthen extending towards amphi position side in engaging ring (42) with coiled material (43).

Description

Medical device
Technical field
Such medical devices such as the conduit (カ テ mono-テ Le) used in the present invention relates to be inserted into organism.
Background technology
It is inserted into the conduit that Ink vessel transfusing uses, it is known to the balloon catheter shown in patent documentation 1 is with special as when treatment The conduit inserting auxiliary as shown in profit document 2.As the performance of these catheter requirements, there are to push at Ink vessel transfusing and lead The transitivity of power during pipe and the resistance to bend(ing) etc. for power to be bent.
It is directed to this, in the above-mentioned following structure that Patent Document 1 discloses: insert in the pipe of metal peri position side Spiral helicine slit is formed on the position of plastic amphi position end side pipe, and across peri position side pipe and amphi position end side pipe Border and at the inner chamber of pipe, heart yearn is set.And, Patent Document 2 discloses following structure: before including in a tubular form End and the axle in thin footpath that extends towards peri position side from this leading section are interior insertion appurtenance, from the metal portion of axle The leading section assigning to tubulose arranges heart yearn.According to these structures, rigidity is gradually reduced towards amphi position side from peri position side, thus Transitivity and resistance to bend(ing) can be improved.
[prior art literature]
[patent documentation]
[patent documentation 1] Japanese Unexamined Patent Publication 2008-237844 publication
[patent documentation 2] Japanese Unexamined Patent Publication 2008-142351 publication
Here, consider be formed be used in conduit time part as the tube chamber of path function on, i.e. inserting Enter in organism and utilize such tubuloses such as metal tube in the part in (or region of configuration in the organism guiding conduit) The situation of intensive aspect.In this case, the stiffening effect of the part being such as inserted in organism raises such that it is able to suppression The situation that above-mentioned path is subject to crushing in vivo.
But, even if in the case of the part in inserting organism utilizes intensive aspect, when considering leading to of the blood vessel bent During the property crossed etc., the entirety of the part inserted in organism is only formed by single intensive aspect and is formed as the feelings of identical rigidity Condition is not preferred, and at least amphi position side needs flexibly to be formed.So, bending becomes problem.It is directed to this, it is also considered that The structure of heart yearn is set as above-mentioned patent documentation 1 or above-mentioned patent documentation 2, but in this case, more uses cross section big Heart yearn more can reduce passage sections.
Summary of the invention
The present invention makes in view of the foregoing, its object is to provide a kind of part in inserting organism to utilize pipe In the structure of the intensive aspect of shape, it is possible to realize the medical device of the raising of resistance to bend(ing) well.
Hereinafter, about the effective ways etc. of the above-mentioned problem of solution, show effect, effect etc. as required and illustrate.
The medical device of the first invention: a kind of medical device, it possesses medical pipe portion, and this medical pipe portion is extremely In a few part is inserted into organism and there is pore as path function in use, the spy of described medical device Levying and be, possess the first intensive aspect of tubulose in the part being inserted in organism in described medical pipe portion, this first adds The distal end section of strong body is positioned at the half-way of the axis direction of this part and the most extended, and in this extension In the range of constitute the wall portion in described medical pipe portion, this first intensive aspect from its distal end section towards the regulation of proximal side Region is formed with the low rigidity of the rigidity of the proximal side than this region and reduces region, but also possesses the second intensive aspect of tubulose, This second intensive aspect laterally extends by amphi position side than this first intensive aspect near position from the distal end section than described first intensive aspect Arranging, the described rigidity being formed as described first intensive aspect reduces below the rigidity in region, and constitutes institute in the range of extending Stating wall portion, this second intensive aspect extends towards amphi position side in the pore of described first intensive aspect.
According to this structure, be formed in the amphi position side of the first intensive aspect rigidity reduce region, and with from the first intensive aspect to The mode that amphi position side extends arranges the second intensive aspect, thus enables that rigidity reduces step by step towards amphi position side, it is achieved resistance to bend(ing) Raising.And, in the way of being constituted wall portion together with the first intensive aspect, the second intensive aspect is formed as tubulose, therefore need not Reduce the passage sections in medical pipe portion, and the raising of resistance to bend(ing) can be realized.
Additionally, the second intensive aspect extends towards amphi position side in the pore of the first intensive aspect, thus deposit with the second intensive aspect Being that the structure of the outer peripheral face side of the first intensive aspect is compared, in medical device is inserted into organism, use is preferred. If the such as first intensive aspect and the second intensive aspect are not embedded in the structure of resin bed or the first intensive aspect and the second intensive aspect buries It is located at the structure that the outer peripheral face of resin bed and this resin bed follows the difference of height (section is poor) of the first intensive aspect and the second intensive aspect, then Compared with the first intensive aspect, it is possible to make amphi position side attenuate and carry cross-country traveling ability.And, even the such as first intensive aspect and second The difference of height that intensive aspect is embedded in the structure of resin bed, the external diameter of this resin bed and the first intensive aspect and the second intensive aspect is unrelated Constant structure, compared with the structure of the outer peripheral face side being present in the first intensive aspect with the second intensive aspect, extends at the second intensive aspect Side also is able to increase the thickness of the resin bed from this second intensive aspect to the outer peripheral face in medical pipe portion.In this case, It is being inserted into thinner endoceliac amphi position side and can improve the elasticity of outer peripheral face side.
The medical device of the second invention: based on the medical device of the first invention, it is characterised in that at least in institute State being inserted in the part in organism of medical pipe portion, described first intensive aspect and described second intensive aspect and be embedded in resin Layer, the inner peripheral surface in described medical pipe portion is at least defined in the region being provided with described second intensive aspect by this resin bed, And the friction possessing the resin formation by the lower friction than the resin portion of outer peripheral face side reduces layer, described second intensive aspect Inner peripheral surface with described friction reduce layer outer peripheral face connect.
According in this structure, at least part in being inserted into organism, the first intensive aspect and the second intensive aspect are buried underground In resin bed, it is possible to give flexibility to outer peripheral face side and these both sides of inner peripheral surface side.And, medical pipe portion can be realized The low frictionization of inner peripheral surface.In this case, the outer peripheral face that the inner peripheral surface of the second intensive aspect reduces layer with friction connects, and thus can The wall portion in enough thinning medical pipe portions.It is thus possible to make medical pipe portion relatively thin and guarantee wider pore.
The medical device of the 3rd invention: based on the medical device of the second invention, it is characterised in that described second Intensive aspect use metal wire be formed as coiled type, and, in described second intensive aspect at least to than described first intensive aspect On the more position by the extension of amphi position side, reduce layer by friction described in the ratio in described friction reduction layer and described resin bed and lean on The basal layer that outer peripheral face side exists is inside and outside clamps described second intensive aspect, and described friction reduction layer and basal layer is linked, and Resin is entered between the most adjacent metal line portions in described second intensive aspect.As it has been described above, passing through In the structure of the wall portion that the outer peripheral face making the inner peripheral surface of the second intensive aspect and friction reduce layer fetches thinning medical pipe portion mutually, The power keeping friction to reduce layer can be improved.
The medical device of the 4th invention: in the first to the 3rd invention based on the medical device of arbitrary invention, its It is characterised by, at least in the part being inserted in organism in described medical pipe portion, described first intensive aspect and described Two intensive aspects are embedded in resin bed, on the region in described second intensive aspect enters into the pore of described first intensive aspect, Resin bed described in non-sandwiched between described first intensive aspect and the second intensive aspect.According to this structure, it is possible to thinning medical pipe portion Wall portion.Thereby, it is possible to make medical pipe portion attenuate and be able to ensure that bigger pore.
The medical device of the 5th invention: based on the medical device of the 4th invention, it is characterised in that described second Intensive aspect use metal wire be formed as coiled type, this resin bed possess at least in the region being provided with described second intensive aspect to institute State the periphery of the interior perisphere that the inner peripheral surface in medical pipe portion is defined, the inner peripheral surface of described second intensive aspect and described interior perisphere Face connects, and the region that described first intensive aspect in described second intensive aspect connects from outer circumferential side, at this second intensive aspect In the most adjacent metal line portions between be formed with the space part that resin is introduced into, and, add described second Qiang Tizhong at least to than described first intensive aspect by amphi position side extend position on, by described interior perisphere and described resin bed In ratio described in the basal layer that exists of side, perisphere outer circumferential side face is inside and outside clamps described second intensive aspect, and will described interior perisphere with Basal layer links, and resin is entered between the most adjacent metal line portions in described second intensive aspect.
According to this structure, as described above, between the first intensive aspect and the second intensive aspect non-sandwiched resin bed and thinning In the structure of the wall portion in medical pipe portion, the facilitation manufactured can be realized.And, at the knot of space part formed as described above In structure, in the second intensive aspect to than the first intensive aspect by amphi position side extend position on, interior perisphere also becomes by second The state linked with basal layer between the metal wire in intensive aspect, therefore can improve the power of perisphere in keeping.
It addition, so-called " rigidity " is to instigate the effect when the direction bending orthogonal with axis direction such as conduit, axle or pipe The size of moment.
Accompanying drawing explanation
Fig. 1 (a) is the figure for the catheter assembly under use state is described, (b) is the front view of outer catheter, and (c) is The front view of inner catheter.
Fig. 2 (a) is by outer tube part and the front view of the outer catheter of periphery enlarged representation thereof, and (b) is by outer tube part and outer shaft The bond sites in portion and the longitudinal sectional view of periphery enlarged representation thereof, (c) is to represent joint ring and the amphi position side in outer shaft portion Front view, (d) is the front view of a part of enlarged representation by reinforcement coiled material (U ィ Le).
Fig. 3 is that (a) represents for illustrating that reinforcement coiled material is present in the explanatory diagram of the situation of inner side and the relation in thin footpath This outer tube part, (b) represents comparative example.
Fig. 4 (a)~(d) are the figures of the manufacture method for outer catheter is described.
Fig. 5 (a) is by the longitudinal sectional view of a part of enlarged representation of the conduit in the second embodiment, and (a1) is to scheme The longitudinal sectional view of a part of enlarged representation of the wall portion of the upside in 5 (a), (b) is to shall illustrate time pipe (Ha ィ Port チ ュ mono-Block) the front view of a part of enlarged representation.
Fig. 6 (a)~(d) are the figures of the manufacture method for conduit is described.
Symbol description:
10... catheter assembly (カ テ mono-テ Le is three-dimensional)
11... outer catheter (ァ ゥ タ カ テ mono-テ Le)
31... outer tube part (ァ ゥ タ pipe portion)
32... outer shaft portion
Outer pore
34... outward opening
41... resin bed
41b... friction reduces layer
42... as the joint ring (ジ ョ ィ Application ト リ Application グ) of the first intensive aspect
43... as the reinforcement coiled material of the second intensive aspect
The most spiral helicine slit
70... conduit (カ テ mono-テ Le)
71... as time pipe of the first intensive aspect
72... as the reinforcement coiled material of the second intensive aspect
74... resin bed
74b... friction reduces layer
Detailed description of the invention
(the first embodiment)
Hereinafter, based on accompanying drawing, illustrate to be applicable to the present invention the first embodiment during catheter assembly.Fig. 1 (a) is to use The figure of the catheter assembly 10 under explanation use state, Fig. 1 (b) is the front view of outer catheter 11, and Fig. 1 (c) is inner catheter 12 Front view.
As shown in Fig. 1 (a)~Fig. 1 (c), catheter assembly 10 possesses outer catheter 11 and inner catheter 12.Outer catheter 11 be for The delivery not shown air bag (バ Le one Application) conduit etc. being imported tip stenotic lesion portion coronarius and utilize Conduit.Inner catheter 12 uses be inserted into outer catheter 11 when the pathological changes portion in organism inserts outer catheter 11 in, is prior to outward Conduit 11 and insertion appurtenance that this insertion is assisted.
As shown in Fig. 1 (c), inner catheter 12 possesses: from amphi position end (front end) to the position, midway of peri position side (base end side) Put, constitute the inner tube portion 21 of the amphi position side of inner catheter 12;Constitute the interior axle portion 22 of side more close than this inner tube portion 21.Inner tube Portion 21 has the inner orifice 23 generally formed at axis direction to open wide to distal end section and these both sides of peri position end, It is integrally formed into tubulose.Inner orifice 23 is utilized to make guide line pass.
It addition, inner tube portion 21 is by polyether block amide copolymer (Port リ ェ mono-テ Le Block ロ ッ Network ァ ミ De) (PEBAX (registration Trade mark)) formed, interior axle portion 22 is formed by metals such as rustless steel or Ni-Ti alloys.And, the distal end section in inner tube portion 21 sets There is the film 24 more soft than its proximal side.
The peri position end opening 25 in inner tube portion 21 is present in the half-way of the axis direction in inner catheter 12.That is, being used for will Guide line is formed at the half-way of the axis direction of inner catheter 12 at the internal orifice that peri position end laterally outside is drawn.It addition, with Under explanation in, for convenience of description, by peri position end opening 25 also referred to as inner opening 25.
The inner opening face of inner opening 25 is formed slopely relative to axis direction, so that it is guaranteed that bigger aperture area.And, In the inner opening 25 tilted, it is biased against the position as peri position side and configures interior axle portion 22, in inner opening 25, as The position of amphi position side becomes the opposition side in interior axle portion 22 across axis.Thus, inner opening 25 has the one-tenth towards peri position side Point, and become the shape making inner orifice 23 keep out of the way to side.And, the direction orthogonal relative to axis direction of inner opening 25 Size is more than interior axle portion 22, and its difference becomes more than the external diameter of guide line G of utilization.
As shown in Fig. 1 (b), outer catheter 11 possesses: from amphi position end to the half-way of peri position side, constitute outer catheter 11 The outer tube part 31 of amphi position side;And constitute than this outer tube part 31 closer to the outer shaft portion 32 of side, position.Outer tube part 31 in order to Opening wide to distal end section and these both sides of peri position end and have the outer pore 33 generally formed at axis direction, entirety becomes Tubulose.This outer pore 33 is in order to make inner catheter 12 and guide line pass and be utilized, and makes the conduits such as balloon catheter pass, this gas The conduits such as ductus bursae are for using pathological changes portion when inner catheter 12 is removed.
The peri position end opening 34 of outer tube part 31 is present in the half-way of the axis direction in outer catheter 11.Here, will lead The guide line utilized when pipe assembly 10 inserts in organism is in than inner opening 25 closer to side, position through outer pore 33.And And, the guide line G that have passed through outer pore 33 is drawn out to outside from the peri position end opening 34 of outer tube part 31.It addition, following In explanation, for convenience of description, also peri position end opening 34 is referred to as outward opening 34.
The external-open actinal surface of outward opening 34 is formed slopely relative to axis direction, so that it is guaranteed that bigger aperture area.And, In the outward opening 34 tilted, it is biased against the position as peri position side to configure outer shaft portion 32, in outward opening 34, as The position of amphi position side becomes the opposition side in outer shaft portion 32 across axis.Thus, outward opening 34 has the one-tenth towards peri position side Point, and become the shape making outer pore 33 keep out of the way to side.And, the size in the direction orthogonal with axis direction of outward opening 34 More than outer shaft portion 32, its difference is more than the external diameter of inner catheter 12.
As shown in Fig. 1 (a), these outer catheters 11 and inner catheter 12 are combined in use and form catheter assembly 10. Under the original state of this catheter assembly 10, the film 24 of inner catheter 12 is more prominent to amphi position end side than outer tube part 31.And, Under original state, outward opening 34 is arranged in than inner opening 25 near a side.The position of this outward opening 34 is catheter assembly 10 The half-way of axis direction, be more specifically that the ratio centre position of total length of catheter assembly 10 is by amphi position side.By This, in the case of importing catheter assembly 10, or to this after the importing of catheter assembly 10 after making guide line G in advance In the case of catheter assembly 10 or outer catheter 11 are replaced, in the both sides of the axis direction across outer tube part 31, it is possible to will In order to the length dimension of the guide line G needed for holding guide line G suppresses shorter, even the result guiding that to be total length short Line G also is able to use.
Inner opening 25 in an initial condition becomes in the structure of above-mentioned position with the relative position of outward opening 34, from closely When side, position is observed, the region that guide line G is passed through becomes to be formed at and guides the guiding pore C1 → outer pore 33 of conduit C → interior Pore 23.That is, the cross-sectional area in the region passed through when inserting guide line G from peri position side is gradually reduced.Thus, easily carry out to The importing of the guide line G of amphi position side.
It addition, outward opening 34 is arranged on same line relative to inner opening 25, and the opening surface of these openings 25,34 inclines Tiltedly, and this opening surface towards composition include the composition towards peri position side.Therefore, import from the outside pore 33 of outward opening 34 Guide line G when being advanced further, the front end of this guide line G is easily directed into opening 25.Similarly, outside from inner opening 25 The guide line G that pore 33 extrudes easily pulls out to the outside of outer catheter 11 through outward opening 34.
Use catheter assembly 10 treat time, first, via descending large artery trunks, large artery trunks bow (longbow) and Up large artery trunks and by guide conduit (ガ ィ デ ィ Application グ カ テ mono-テ Le) C distal end section be arranged in entering of left coronary artery Mouthful, start to make catheter assembly 10 prominent to amphi position end side from this state and carry out insertion operation the most coronarius.This In the case of, film (ソ Off ト チ ッ プ) 24 highlights from outer catheter 11, it is possible to carry cross-country traveling ability.And, when occlusion site is deposited Time, it is possible to gradually press off occlusion site from film 24 side.
It follows that with reference to Fig. 2, explain the structure of outer catheter 11.
Fig. 2 (a) is by the front view of the outer catheter 11 of outer tube part 31 and periphery enlarged representation thereof, and Fig. 2 (b) is by outer tube part 31 represent composition outer tube part 31 with the bond sites in outer shaft portion 32 and the longitudinal sectional view of periphery enlarged representation thereof, Fig. 2 (c) Engaging the front view of the amphi position side in ring 42 and outer shaft portion 32, Fig. 2 (d) is of the reinforcement coiled material 43 by constituting outer tube part 31 The front view of part enlarged representation.
As shown in Fig. 2 (b), outer tube part 31 is buried at the resin bed 41 being defined inner peripheral surface and the outer peripheral face of its wall portion It is provided with the joint ring 42 (with reference to Fig. 2 (c)) arranged as the first intensive aspect and the reinforcement arranged as the second intensive aspect is used Coiled material 43 (with reference to Fig. 2 (d)).Further, outer tube part 31 is constituted by these resin beds 41, joint ring 42 and reinforcement coiled material 43 Wall portion.
In these resin beds 41, joint ring 42 and reinforcement with in coiled material 43, first describe resin bed 41 in detail.
As shown in Fig. 2 (b), resin bed 41 possesses: the basal layer 41a being defined the outer peripheral face of outer tube part 31;Externally The friction that the inner peripheral surface in pipe portion 31 is defined reduces layer 41b.Basal layer 41a is formed by polyamide series resin.Polyamide-based tree Fat refers to utilize amido link (conjunction of ァ ミ De) to form the synthetic resin that body or copolymer are polymerized alone, as basal layer 41a, Specifically, nylon (registered trade mark) such polyamide and polyether block amide copolymer (Port リ ェ mono-テ Le Block are used ロ ッ Network ァ ミ De) (PEBAX) such polyamide elastomer and formed.In this case, basal layer 41a is in the institute of axis direction Polyamide elastomer is the most more used to be formed on some positions, so that it is guaranteed that the flexibility of outer tube part 31.
It addition, basal layer 41a can also use the synthetic resin different from polyamide and the bullet of this synthetic resin system Gonosome is formed.And, basal layer 41a need not utilize both polyamide and polyamide elastomer to be formed, it is also possible to only profit Formed with the side in polyamide and polyamide elastomer.And, basal layer 41a need not utilize polyamide series resin to be formed, Polyethylene, polyethylene terephthalate (Port リ ェ チ レ Application テ レ Off タ レ-ト), polypropylene (Port リ プ ロ ピ レ can also be used Application), polyurethane (Port リ ゥ レ タ Application), polyimides, polyimides elastomer, silicone rubber etc. formed.
On the other hand, when friction reduces layer 41b to slide in reducing inner catheter 12 or other conduit pore 33 outside Resistance, and use politef (Port リ テ ト ラ Off Le ォ ロ ェ チ レ Application) (PTFE) to be formed.Friction reduce layer 41b in order to The entirety of the inner peripheral surface of outer tube part 31 is defined and arranges, if but existing and slide what incidental position and being difficult to occurred Position, then can be arranged at local.It addition, the material forming friction reduction layer 41b is not defined to PTFE, it is possible to use its The hydrophilic polymer of his fluorine resin or maleic anhydride (acid of water マ レ ィ Application) copolymer etc..
Additionally, as resin bed 41, the distal end section in outer tube part 31 is provided with higher closer to the flexibility of side, position than it Lateral film 41c.Thus, even if in the case of the distal end section of outer tube part 31 contacts with blood vessel wall, also can reduce and now execute Add to the load of blood vessel wall.This lateral film 41c is formed by polyamide elastomer but it also may formed by different materials.
It follows that explanation engages ring 42.
Engage ring 42 and be embedded in resin bed 41 in the peri position side of outer tube part 31, in order to by outer shaft portion 32 with outer tube part 31 even Tie and utilize.And, engage the function that ring 42 also functions to strengthen the peri position side of outer tube part 31, it is possible to suppression operator The situation that when operating the peri position end in outer shaft portion 32, outward opening 34 periphery of outer tube part 31 is subject to crushing.
If the structure of docking cyclization 42 is described in detail, then this joint ring 42 is formed as tubular or pipe by rustless steel Shape, engages the pore 51 both ends open at axis direction.It addition, engage ring 42 to be not limited to stainless steel, it is also possible to by Ni- The superelastic alloy such as Ti alloy or other metal are formed.
The opening 52 of the amphi position side in two openings of joint ring 42 is with its opening surface and the orthogonal axe engaging ring 42 Mode is formed, in contrast, the opening 53 of peri position side is corresponding to the outward opening 34 having been described above, with its opening surface relative to connecing The mode that the axis of cyclization 42 tilts is formed.It addition, in the following description, also it is referred to as engaging side by the opening 53 of peri position side Beveled 53.Relative to dividing the circumference forming the beveled 53 engaging side, engage outer shaft portion 32.
Outer shaft portion 32 deforms in the way of its distal end section is formed as front end point.This tip, front end 54 is not make side face whole Body becomes the mode of taper and is formed towards front end, but by being formed flattening (The) across the side of axis to opposite side The shape of front end point.In this case, tip, front end 54 has: axis direction comprise on the whole with than it closer to position end The part of side is the basal surface 54a of the part of the same face (face one);And with the distance with basal surface 54a towards amphi position side Inclined plane 54b that the mode become narrow gradually tilts.
Tip, front end 54 tilts from inner side and proximally side at the beveled 53 engaging side with its basal surface 54a The mode that the inner peripheral surface of the circumference tilting point (tilting first) abuts configures, thus is engaged with basal surface 54a by described inner peripheral surface. By to many places (at specifically 2) irradiating laser, in the generation welding position, many places separated in the axial direction to carry out institute State joint.Thus, joint ring 42 and outer shaft portion 32 are firmly fixed.And, engage by touching basal surface 54a, from And the axis direction (that is, the axis direction of outer catheter 11) that makes the axis direction in outer shaft portion 32 become and engage ring 42 is parallel.
As shown in Fig. 2 (c), form spiral helicine slit 55 as rigidity reduction structure engaging ring 42, in order to suppression The local that rigidity occurs in the position being provided with this joint ring 42 raises.From engaging the distal end section of ring 42 to than the inclination engaging side Opening 53 by the position of front, makes a series of indentation (cutting り body) pivot becoming spiral helicine mode, is consequently formed Spiral helicine slit 55.In this case, the live width of a series of indentation becomes about 0.025mm, but as long as joint can be played The function of ring 42 and can play the function that the desired rigidity of spiral helicine slit 55 reduces, live width just can be any.
Spiral helicine slit 55 with amphi position side than between the indentation of the most adjacent wire of peri position side Formed away from the mode reduced.That is, spiral helicine slit 55 is in the way of the rigidity engaging ring 42 is gradually lowered towards amphi position side Formed.Thus, the local that can suppress rigidity raises, it is possible to increase resistance to bend(ing).
The joint ring 42 of said structure is embedded in basal layer 41a as has been explained above, in the outer peripheral face side of outer tube part 31 And inner peripheral surface side all do not exposes.Specifically, as shown in Fig. 2 (b), engage the thickness of ring 42 wall portion of pore 33 the most outside On direction, the most also become the state being embedded in resin bed 41.Therefore, the circumference of outward opening 34 is not by engaging The beveled 53 of side is formed, and is formed by resin bed 41.Thus, utilize and engage ring 42 and carry out adding of outward opening 34 and periphery thereof By force, and metal joint ring 42 does not exposes at the circumference of outward opening 34.
The direction of the inclined plane engaging the beveled 53 of side is identical with the direction of the inclined plane of outward opening 34.That is, engage The position around axle at the position becoming amphi position side at the beveled 53 of side with at outward opening 34, become amphi position The position around axle at the position of side is identical, engage the position becoming peri position side at the beveled 53 of side around axle Position is identical with the position around axle at the position of the peri position side at outward opening 34.Therefore, with the outer shaft engaging ring 42 joint The position becoming peri position side at outward opening 34, the portion 32 extends towards peri position side.
Joint ring 42 is covered by resin bed 41 with the intersection in outer shaft portion 32.And, in outer shaft portion 32 towards amphi position The amphi position end face of side, from the relation that the inner circumferential engaging ring 42 erects towards axis side, produces at the position covering this amphi position end face Cascaded surface 56 towards amphi position side.Cascaded surface 56 is formed as curved in the way of keeping out of the way the most laterally towards amphi position side, but It is formed extended at both sides to the direction orthogonal with axis direction and also may be used into plane.Thus by being formed as the thickness of resin bed 41 producing The degree of raw cascaded surface 56, and can suppress to globality the thickness of the wall portion of outer tube part 31, it can be ensured that bigger outer tube The aperture in hole 33.
It addition, become than at the beveled 53 engaging side to become the position of amphi position side at outward opening 34 The position of amphi position side forms resin bed 41 closer to the mode of side, position, but by making inner peripheral surface towards the outside of outward opening 34 Move closer to outer peripheral face, and make the part thin-walled property at the position being formed into amphi position side of this outward opening 34.Thereby, it is possible to Guarantee wider outward opening 34.
It follows that explanation reinforcement coiled material 43.
As shown in Fig. 2 (a), the entirety of reinforcement coiled material 43 is embedded in resin bed 41.It addition, in Fig. 2 (a), in order to just In explanation, and reinforcement coiled material 43 is made to increase than actual size relative to the relative size of the length direction of outer tube part 31.
Reinforcement coiled material 43 by make the metal wire of stainless steel spirally around, and be formed as axis direction conduct The coiled type of length direction, and utilize metal wire to mark off the coiled material pore 43a extended in the axial direction.It addition, reinforcement volume Material (U ィ Le) 43 is not defined to stainless steel, it is also possible to utilize superelastic alloy or other the metal shapes such as Ni-Ti alloy Become.
Spacing between the most adjacent linear parts of reinforcement coiled material 43 is the most constant or substantially Constant, the live width of the indentation of a series of () that this spacing is set greater than in spiral helicine slit 55.As long as this spacing is full The above-mentioned condition of foot, can be any, but for example, 0.25mm.And, a series of linear parts of reinforcement coiled material 43 Gauge (such as 0.01mm) is set smaller than the gauge of metallic walls engaging ring 42, and a series of linear parts Live width (width) (such as 0.08mm) be also set to less than the spiral helicine slit 55 engaged in ring 42 between minimum dimension.And And, the result that these sizes set is, the rigidity of reinforcement coiled material 43 is set smaller than to engage and is formed with helical form at ring 42 The rigidity in region of slit 55.
Here, described as already described, in engaging ring 42, spiral helicine slit 55 gradually becomes towards amphi position side with spacing Narrow mode is formed.Therefore, when the comparison utilizing joint ring 42 and reinforcement coiled material 43 to carry out rigidity, engage in ring 42, with The proximal side in the region being formed with spiral helicine slit 55 is compared, and is formed with the amphi position side in the region of this spiral helicine slit 55 Rigidity reduces, and compared with the amphi position side in the region being formed with this spiral helicine slit 55, the rigidity of reinforcement coiled material 43 sets Relatively lowly fixed.
It addition, appoint for the rigidity of reinforcement coiled material 43 being set to the concrete structure less than the rigidity engaging ring 42 Meaning, such as by adjusting reinforcement at least one parameter in the live width of material, spacing and the linear parts of coiled material 43, even if Above-mentioned gauge is identical or reinforcement coiled material 43 bigger in the case of, also can make this reinforcement coiled material 43 than engaging in ring 42 The rigidity in the region being formed with spiral helicine slit 55 is little.
As shown in Fig. 2 (b), the reinforcement peri position end of coiled material 43 engages the distal end section of ring 42 closer to position end at ratio Side exists, and specifically exists in the position of outward opening 34, and distal end section engages, with ratio, the side that ring 42 exists by amphi position side Formula extends, arranging the most on the whole of outer tube part 31.Thus, can be played by reinforcement coiled material 43 outer tube part 31 is added Strong function, can suppress the situation that outer pore 33 is subject to crushing when using outer catheter 11.
The internal diameter that the external diameter of reinforcement coiled material 43 is set to than engaging ring 42 is little, and this reinforcement passes with coiled material 43 and engages pore In 51.That is, reinforcement coiled material 43 extends towards amphi position side in the joint pore 51 engaging ring 42.Further, outward opening 34 with Engage on the position around axle in the region between the beveled 53 of side, existing for the distal end section of these each openings 34,53 Side produces and engages the non-existent region of ring 42, but puts into reinforcement coiled material 43 in this region.Thus, the circumference of outward opening 34 Being reinforced, this outward opening 34 is difficult to damage by pressure.
On the other hand, there is the peri position of outward opening 34 closer to side, position in the junction than joint ring 42 and outer shaft portion 32 In the structure of end, the peri position end of reinforcement coiled material 43 be present in than outer shaft portion 32 the most above-mentioned cascaded surface of amphi position end face 56 more By amphi position side.At outward opening 34, existing for the distal end section of the region existing for above-mentioned junction and above-mentioned outward opening 34 Region different, by engaging ring 42 and outer shaft portion 32 strengthens.Therefore, in such region, do not make reinforcement coiled material 43 extend, It is possible to guarantee wider outward opening 34.
As it has been described above, by arranging reinforcement coiled material 43, when observing outer tube part 31 from peri position side, connect according to being embedded with The region in cyclization 42 and outer shaft portion 32 → be embedded with engage the region of the non-rigid reduction region of ring 42 and reinforcement coiled material 43 → Be embedded with engage the rigidity of ring 42 reduce the region of region and reinforcement coiled material 43 → be embedded with reinforcement coiled material 43 region this The order of sample, each region continuous arrangement.Thus, in being provided with the structure engaging ring 42, it is possible to make the rigidity of outer tube part 31 towards Amphi position side is gradually reduced.Especially be provided with engage ring 42 region with than its more by amphi position side region boundary member on The bigger change of rigidity is alleviated because of the existence of reinforcement coiled material 43, thus resistance to bend(ing) improves.
Additionally, the coiling direction of the metal wire of reinforcement coiled material 43 becomes the rotation of the spiral helicine slit 55 engaged in ring 42 Opposite direction around (circumference) direction.Thus, the direction being easily bent produced in outer tube part 31 because of spiral helicine slit 55 Directivity applies reciprocal directivity with coiled material 43 because being reinforced and easily offsets.
It follows that explanation engages the relative position of ring 42 and reinforcement coiled material 43 and resin bed 41.
As has been explained above, metal joint ring 42 and metal reinforcement coiled material 43 are owing to being embedded in resin bed 41, and do not expose in the outer peripheral face side of outer tube part 31.Thus, when organism is inserted into, can prevent from engaging ring 42 and strengthening using The situation that coiled material 43 contacts with blood vessel wall.It is additionally, since the inner peripheral surface side engaging ring 42 and reinforcement coiled material 43 in outer tube part 31 Do not expose, inner catheter 12 or other conduit can be prevented to be hooked in spiral helicine slit 55 or the situation of web part yet.
Engage ring 42 and reinforcement with in the region existing for these both sides of coiled material 43, engage ring 42 and reinforcement coiled material 43 Between be formed with the sandwiched layer being made up of the basal layer 41a of resin bed 41.
Specifically, as shown in Fig. 2 (b1), engage ring 42 and clamped by inside and outside basal layer 41a.In this case, basal layer 41a does not carries out thermal welding (molten) for engaging the region being formed with spiral helicine slit 55 in ring 42, and does not carries out Bonding (then).Thus, though engage ring 42 by inside and outside basal layer 41a clamp, also can play well be provided with spiral helicine narrow Function produced by seam 55.And, although so for being provided with the non-thermal welding in the region basal layer 41a of spiral helicine slit 55, But by docking cyclization 42 is not provided with the region thermal welding basal layer 41a of spiral helicine slit 55, and engages ring 42 and exist Clamped by basal layer 41a on axis direction and be embedded in this basal layer 41a, the most also can prevent from engaging the position changing of the relative positions of ring 42.
On the other hand, reinforcement coiled material 43 connects by making inner peripheral surface side reduce layer 41b with friction, and is reduced layer by friction The inside and outside clamping of 41b and basal layer 41a.In this case, friction reduces layer 41b and strengthens existence between the metal wire with coiled material 43 Basal layer 41a connects, and at the position welding basal layer 41a that this connects.Thus, in the wall portion in order to realize outer tube part 31 Thin-walled property and make the inner peripheral surface side of reinforcement coiled material 43 reduce in the structure that layer 41b connects with friction, it is possible to make friction reduce layer 41b is kept by basal layer 41a, is not easily stripped so that friction reduces layer 41b.
It addition, basal layer 41a carries out thermal welding relative to reinforcement coiled material 43 but it also may do not carry out relative to strengthening using The thermal welding of coiled material 43.In this case, by reinforcement coiled material 43 being embedded in resin bed 41, reinforcement coiled material can also be prevented The position changing of the relative positions of 43.
Here, with reference to Fig. 3 (a)~Fig. 3 (b), illustrate that reinforcement coiled material 43 is present in the situation of inner side and the pass in thin footpath System.
Fig. 3 (a)~Fig. 3 (b) is for illustrating that reinforcement coiled material 43 is present in the situation of inner side and the relation in thin footpath Explanatory diagram, Fig. 3 (a) represents the situation of this outer tube part 31, and Fig. 3 (b) is denoted as the outer tube part 101 of comparative example.
In the comparative example of Fig. 3 (b), use and the joint ring 102 that ring 42 is identical that engages of Fig. 3 (a), but reinforcement coiled material 103 is different from the situation of Fig. 3 (a), are arranged in the outside engaging ring 102.And, in this comparative example, possess basal layer 104a With friction reduction layer 104b as resin bed 104, and the gauge of friction reduction layer 104b is identical with the situation of Fig. 3 (a), but The gauge of basal layer 104a is different from the situation of Fig. 3 (a).
The point that the gauge of basal layer 104a is different is described in detail, engages inner peripheral surface and the outer tube part of ring 102 Distance X1 between the inner peripheral surface of 101 is to guarantee that basal layer 104a and friction reduce melting between layer 104b fully for realization Connect intensity and engage the prominent at least one party among these of the outside pore of ring 102 105, the distance of this specific purpose.This feelings Under condition, in Fig. 3 (b), this distance X1 is formed as the thickness gauge of the metal wire of reinforcement coiled material 103 in the case of Fig. 3 (a) Very little, it is contemplated that actually need the situation more than this gauge in order to realize above-mentioned specific purpose.
It addition, in order to be reliably suppressed the interference engaging ring 102 with reinforcement coiled material 103, and make to engage outside ring 102 Side face and reinforcement distance X2 between the inner peripheral surface of coiled material 103 are equal to the periphery strengthening using coiled material 43 in the case of Fig. 3 (a) Distance between face with the inner peripheral surface engaging ring 42.And, in order to be adequately suppressed the shadow to blood vessel wall of reinforcement coiled material 103 Ring, and strengthen by distance X3 between outer peripheral face and the outer peripheral face of outer tube part 101 of coiled material 103 equal in the case of Fig. 3 (a) Engage the distance between outer peripheral face and the outer peripheral face of outer tube part 31 of ring 42.
When the comparative example being made under conditions of above-mentioned and this outer tube part 31 are compared, such as Fig. 3 (a) and Fig. 3 (b) institute Show, compared with comparative example, it is possible to make the ratio of this outer tube part 31 engage ring 42 thinner by amphi position side.
It addition, in this outer tube part 31, also utilize the basal layer 41a between the metal wire entering into reinforcement coiled material 43 to come real Existing above-mentioned specific purpose, in contrast, in a comparative example, only for realizing under above-mentioned specific purpose this purpose, base Bottom 104a is present in the inner side engaging ring 102.Therefore, compared with comparative example, this outer tube part 31 can reduce the thickness of wall portion Degree size, result is compared with comparative example, and this outer tube part 31 can reduce external diameter.
It follows that with reference to Fig. 4 (a)~Fig. 4 (d), the manufacture method of outer catheter 11 is described.
First, as shown in Fig. 4 (a), constituting friction and reducing the outer peripheral face of the first pipe 61 of layer 41b, by metal wire 62 with The spacing of regulation is wound into helical form, thus carries out being formed the operation of reinforcement coiled material 43.It follows that as shown in Fig. 4 (b), enter Row covers reinforcement and is formed by synthetic resin (specifically nylon (Na ィ ロ in the outside of the first pipe 61 by the entirety of coiled material 43 Application)) operation of the first basal layer 63 that constitutes.Then, as shown in Fig. 4 (c), the outside hot melt at this first basal layer 63 is carried out Connect the operation of another synthetic resin (specifically PEBAX).In this case, the synthetic resin of this thermal welding is polyamide bullet The synthetic resin of gonosome and above-mentioned first basal layer 63 is polyamide, i.e. for same synthetic resin system, therefore in the conjunction of thermal welding There is not border between resin and the first basal layer 63, thus form the second basal layeres 64 based on both.This operation is tied Shu Shi, the formation of inside tube 65 terminates.
As it has been described above, reduce the outside of layer 41b in friction to form the first basal layer 63, and outside it thermal welding with this The synthetic resin that one basal layer 63 is different, thus improves friction in the first basal layer 63 side and reduces layer 41b or reinforcement coiled material 43 Retentivity, and the flexibility of outer tube part 31 can be improved in above-mentioned thermal welding side simultaneously.If it addition, friction reduces layer 41b side Formed by the synthetic resin specified, and do not formed by the elastomer of the synthetic resin system of this regulation outside it, then can omit State the side in the formation process of the first basal layer 63 and the thermal welding process of above-mentioned synthetic resin.
It follows that as shown in Fig. 4 (d), carry out following operation: utilize inside tube 65 formed as discussed above and by synthesizing The pipe that resin (specifically PEBAX) is constituted, will be bonded to the inside and outside clamping of joint ring 42 in outer shaft portion 32, and make this two Pipe thermal welding.In this case, as has been explained above, for engaging the district being formed with spiral helicine slit 55 in ring 42 Territory, does not carries out this thermal welding.And, the pipe and the synthetic resin forming inside tube 65 that are made up of above-mentioned synthetic resin are same conjunction Resin system, therefore there is not border in the basal layer 41a after the thermal welding of above-mentioned two pipes.
According to present embodiment described in detail above, following excellent effect can be played.
Spiral helicine slit 55 is formed engaging ring 42, and with from being formed with the region of this spiral helicine slit 55 towards far The mode that side, position extends arranges reinforcement coiled material 43, thus enables that the rigidity of outer tube part 31 declines step by step towards amphi position side.By This, it is achieved the raising of resist bending (キ Application Network) property.And, in the way of being constituted wall portion together with engaging ring 42, reinforcement is rolled up Material 43 is formed as tubulose, can realize the raising of resistance to bend(ing) thus without the passage sections reducing outer catheter 11.This situation Under, reinforcement coiled material 43 extends towards amphi position side from the inner side engaging ring 42, the most as has been explained above, can realize outer tube part The thin footpath of 31.
It addition, the purposes of catheter assembly 10 be not defined for deliver (デ リ バ リ) balloon catheter such other The purposes of conduit, such as, can also be to utilize outer catheter 11 as negative pressure catheter and to utilize inner catheter 12 as inserting appurtenance Structure.And, in order to deliver the stent (ス テ Application ト) of self expanding, it is also possible to utilize catheter assembly 10, The distal end section of distal end section or outer catheter 11 in order to utilize inner catheter 12 comes stamping-out occlusion site or narrow, it is possible in order to By catheter assembly 10.
Alternatively, it is also possible to the inner catheter 12 above-mentioned first embodiment is suitable for by the structure be applicable to outer catheter 11.
(the second embodiment)
In the above-described first embodiment, premised on the conduit that the combination by pipe portion Yu axle portion is formed, but at this In embodiment, by premised on the substantially overall conduit formed by pipe portion of axis direction.And, multiple intensive aspects are to conduit Resin bed to bury form underground different from above-mentioned first embodiment.Hereinafter, with reference to Fig. 5, this different structure is described.
Fig. 5 (a) is by the longitudinal sectional view of a part of enlarged representation of conduit 70, and Fig. 5 (a1) is upper by Fig. 5 (a) The longitudinal sectional view of a part of enlarged representation of the wall portion of side, Fig. 5 (b) is time pipe (the Ha ィ being embedded in conduit 70 for explanation Port チ ュ mono-Block) 71 the front view by a part of enlarged representation.
As shown in Fig. 5 (a), in conduit 70, the wall portion being imported into the part in organism in use buries metal underground The secondary pipe 71 of system is as the first intensive aspect, and buries metal reinforcement coiled material 72 underground as the second intensive aspect.Secondary as being formed The material of pipe 71, can be listed in above-mentioned joint ring 42 material illustrated, as forming the reinforcement material of coiled material 72, permissible List the material illustrated in above-mentioned reinforcement coiled material 43.
As shown in Fig. 5 (b), it is formed with spiral helicine slit 73 at secondary pipe 71.Spiral helicine slit 73 is from secondary pipe 71 The half-way of the axis direction of distal end section to this time pipe 71, makes a series of indentation revolve around axle to become spiral helicine mode Around and formed.Spiral helicine slit 73 is with the gap ratio peri position end between the indentation of the most adjacent wire of amphi position side The little mode in side is formed.
Spacing between the most adjacent linear parts of reinforcement coiled material 72 is the most constant or substantially Constant.Its spacing is set to the live width more than a series of indentation in spiral helicine slit 73.This reinforcement coiled material 72 near The half-way of the axis direction in the region being formed with spiral helicine slit 73 that end, position is present in time pipe 71.And, from Described half-way extends towards amphi position side, and extends to amphi position side than secondary pipe 71.Strengthen with coiled material 72 than the shape in secondary pipe 71 The rigidity becoming to have the region of spiral helicine slit 73 is low, therefore, it is possible to make the rigidity of conduit 70 decline step by step towards amphi position side.
Secondary pipe 71 and reinforcement coiled material 72 are embedded in has basal layer 74a and the resin bed 74 of friction reduction layer 74b.Separately Outward, as the material of formation basal layer 74a, the material illustrated in above-mentioned basal layer 41a can be listed, as forming friction Reduce the material of layer 74b, the material illustrated in above-mentioned friction reduces layer 41b can be listed.And, reinforcement with coiled material 72 from The inner side of secondary pipe 71 extends towards amphi position side.
On the region being provided with reinforcement coiled material 72, i.e. leaning on amphi position side than the region being provided with time pipe 71, with from outside Cover reinforcement coiled material 72 and enter and form basal layer from outside with the friction reduction mode that connects of layer 74b between linear parts 74a.And, on the region being provided with time pipe 71, i.e. it is provided with the region of reinforcement coiled material 72 closer to side, position at ratio, at secondary pipe Sandwiched basal layer 74a between 71 and friction reduction layer 74b.The outside reducing layer 74b from friction at basal layer 74a reduces with friction In the region that layer 74b connects, basal layer 74a is reduced layer 74b thermal welding with friction.
On the other hand, between secondary pipe 71 and reinforcement coiled material 72, non-sandwiched basal layer 74a, is arranged with radially In the region of secondary pipe 71 and reinforcement coiled material 72, the inner peripheral surface of secondary pipe 71 connects with the outer peripheral face of reinforcement coiled material 72.And, add Reduce layer 74b with friction with the inner peripheral surface of coiled material 72 in the same manner as above-mentioned first embodiment by force to connect, but at reinforcement coiled material In 72, time pipe 71 is from the region that outside connects, and basal layer 74a is introduced between the most adjacent linear parts.That is, exist In this region, between the most adjacent linear parts, produce space part 75.
In said structure, friction reduce layer 74b there are in the prescribed limit of axis direction only with reinforcement coiled material 72 regions connected, but compared with this region, friction reduces in layer 74b wider with the region of basal layer 74a welding, therefore rubs Reduce layer 74b to be difficult to peel off from basal layer 74a.And, in friction reduces layer 74b, as described above, only roll up with reinforcement The region that material 72 connects is formed with the state being stretched in the axial direction, is therefore difficult to the pore 70a lateral bend of conductive pipe 70.And And, as described above, in the region only connected with reinforcement coiled material 72, from outside and adding that friction reduction layer 74b connects By force being set to narrower by the spacing between the linear parts in coiled material 72, therefore other conduit etc. are by the pore 70a of conduit 70 Time interior, connecting even if layer 74b should be reduced by object with friction, this friction reduces layer 74b bending laterally also by strengthening Suitably bear with coiled material 72.
It addition, in the above-described first embodiment, at the outer peripheral face of outer catheter 11, deposited in the distal end section engaging ring 42 Position produce difference of height laterally, but do not produce difference of height at the outer peripheral face of the conduit 70 of present embodiment, and outer Footpath is the most constant.And, non-thermal welding substrate on the region being formed with spiral helicine slit 73 in secondary pipe 71 This one side of layer 74a, as above-mentioned outer tube part 31, plays same action effect based on above-mentioned structure.
It follows that with reference to Fig. 6 (a)~Fig. 6 (d), the manufacture method of conduit 70 is described.
First, as shown in Fig. 6 (a), constituting friction and reducing the outer peripheral face of the first pipe 81 of layer 74b, by metal wire 82 with The spacing of regulation is wound into helical form, thus carries out being formed the operation of reinforcement coiled material 72.
It follows that as shown in Fig. 6 (b), in reinforcement with in coiled material 72, in addition to the final region overlapped with time pipe 71, Carry out being formed the operation of the ground floor 83 being made up of synthetic resin (specifically nylon) in the outside of the first pipe 81.Now, This ground floor 83 is heat fused in friction and reduces layer 74.And, this ground floor 83 is discontinuous, than this locus of discontinuity in the axial direction Territory 83a more leans on the thickness of the layer of the first area 83b being embedded with reinforcement coiled material 72 of amphi position side to be more than, and compares discontinuity zone 83a is closer to the thickness of the layer of the second area 83c not burying reinforcement coiled material 72 underground of side, position.The thickness of this two region 83b, 83c The difference of degree is equal to the thickness of the wall portion of time pipe 71.
It follows that as shown in Fig. 6 (c), the second pipe 84 formed as discussed above covers time pipe 71.In this case, This second pipe 84 is inserted in the pore of time pipe 71 from the peri position side of the second pipe 84, but when this insertion, the inner circumferential of secondary pipe 71 Slide on the outer peripheral face of reinforcement coiled material 72 and above-mentioned second area 83c in face.And, by the distal end section of secondary pipe 71 from closely Side, position abuts the location carrying out direction of insertion with first area 83b.And, behind this location, first area 83b Outer peripheral face become the same face relative to the outer peripheral face of secondary pipe 71.
It follows that as shown in Fig. 6 (d), carry out following operation: for above-mentioned the second pipe positioning time pipe 71 84, by the outer peripheral face of the outer peripheral face and secondary pipe 71 that cover the second pipe 84 overall in the way of formed by synthetic resin (specifically It is PEBAX) second layer 85 that constitutes.Thus, the manufacture of conduit 70 terminates.In this case, before forming this second layer 85 In one stage, as described above, the outer peripheral face of secondary pipe 71 outer peripheral face relative to first area 83b becomes the same face, therefore can be real The now facilitation of the setting of the thickness on the basis of the formation second layer 85.And, as has been explained above, in secondary pipe 71 It is formed with the region of spiral helicine slit 73, does not carries out the thermal welding of the second layer 85.And, the second layer 85 and formation ground floor 83 Synthetic resin be identical synthetic resin system, therefore there is not ground floor in the basal layer 74a after the thermal welding of the second layer 85 Border between 83 and the second layer 85.
According to present embodiment described in detail above, following excellent effect can be played.
Spiral helicine slit 73 is formed at secondary pipe 71, and with from being formed with the region of this spiral helicine slit 73 towards far The mode that side, position extends arranges reinforcement coiled material 72, thus enables that the rigidity of conduit 70 declines step by step towards amphi position side.By This, can realize the raising of resistance to bend(ing).And, in the way of being constituted wall portion together with secondary pipe 71, reinforcement coiled material 72 is formed For tubulose, thus without reducing the passage sections of conduit 70, and the raising of resistance to bend(ing) can be realized.In this case, strengthen using Coiled material 72 from the inner side of secondary pipe 71 towards amphi position side extend, therefore the external diameter of conduit 70 is formed as regulation size, and The side that reinforcement coiled material 72 extends, it is possible to increase from this reinforcement coiled material 72 basal layer to the outer peripheral face of conduit 70 The thickness of 74a.Thus, it is being inserted into thinner endovascular amphi position side, the elasticity of outer peripheral face side can improved.
It addition, between secondary pipe 71 and reinforcement coiled material 72 non-sandwiched basal layer 74a, it is possible to the tube wall of conduit 70 Portion is formed relatively thin.Thus, the external diameter of conduit 70 is not increased, it becomes possible to guarantee the aperture of bigger pore 70a.And, it is possible to The external diameter of conduit 70 is reduced in the case of the aperture not reducing pore 70a.
It addition, as the purposes of above-mentioned conduit 70, list by removing blood to applying negative pressure in pore for attracting The negative pressure catheter of bolt etc., in balloon catheter in order to make airbag inflation/contraction and for the conduit portion of fluid circulation.And, row Enumerate as guided conduit or above-mentioned outer catheter 11, the conduit utilized in order to other conduit is imported.
Alternatively, it is also possible to for putting into basal layer between the most adjacent linear parts in reinforcement coiled material 73 74 and be formed without the structure of space part 75.
It addition, be conceived to the wall portion of conduit 70 to be formed relatively thin such effect time, leaning on than secondary pipe 71 The outside of radial direction there are in the structure of reinforcement coiled material 72, it is also possible to is useful in these pipe 71 and reinforcement coiled material 72 Between the structure of non-sandwiched resin bed 74.
(other embodiment)
The present invention is not defined to the contents of the respective embodiments described above and the most following implements.
(1) in the above-described first embodiment, it is also possible to engaging the most sandwiched resin between ring 42 and reinforcement coiled material 43 Layer 41.In this case, the thin-walled property of the wall portion of outer catheter 11 can be realized.And, in the above-described 2nd embodiment, it is possible to To be folded with resin bed 74 between secondary pipe 71 and reinforcement coiled material 72.In this case, metal contact each other can be prevented.
(2) in the above-described first embodiment, only in the region being formed with spiral helicine slit 55 engaged in ring 42 not Carry out the thermal welding of basal layer 41a, but be not limited to this, it is also possible to be that the entirety engaging ring 42 is not carried out based on basal layer The thermal welding of 41a.In this case, by joint ring 42 is embedded in basal layer 41a, it is possible to prevent the position of this joint ring 42 The changing of the relative positions.
(3) reinforcement coiled material 43,72 can also be replaced, use and be formed as latticed braided tube (チ by metal wire ュ mono-Block).In this case, be dimensioned so as to basal layer 41a, 74a of the mesh of this braided tube is easier to from spiral helicine narrow The size of seam 55,73 entrance, it is possible to guarantee that bigger basal layer 41a, 74a reduces the contact surface of layer 41b, 74b with friction Long-pending such that it is able to improve friction and reduce the retentivity of layer 41b, 74b.
(4) the rigidity reduction region being formed at joint ring 42 or secondary pipe 71 is not defined to by spiral helicine slit 55,73 The structure formed, it is also possible to be the structure formed by the slit of linearity or be formed as latticed structure, it is also possible to be to pass through Wall thickness or external diameter is made to reduce the structure formed towards amphi position side.
(5) rigidity of reinforcement coiled material 43,72 can also with engage in ring 42 or secondary pipe 71 be formed spiral helicine narrow The rigidity in the region of seam 55,73 is identical.In this case, the rigidity of reinforcement coiled material 43,72 both can be formed with helical form Slit 55,73 region in the highest position of rigidity identical, it is also possible to the position minimum with rigidity is identical.
(6) sandwiched basal layer between layer 41b, 74b can also be reduced at the inner peripheral surface of reinforcement coiled material 43,72 and friction 41a、74a.In this case, basal layer 41a, 74a are heat fused in friction reduce layer 41b, 74b and be heat fused in reinforcement volume Material 43,72, thus can improve the retentivity of each interlayer.
(7) resin bed 41,74 not only possesses friction reduction layer in the inner circumferential side of basal layer 41a, 74a, and at outer circumferential side Can also possess friction and reduce layer.It addition, friction reduces layer 41b, 74b is not necessarily formed at inner peripheral surface or the conduit 70 of outer tube part 31 The entirety of inner peripheral surface, it is also possible to be made only in be provided with reinforcement coiled material 43,72 region, i.e. easily with other component generation A part for the inner peripheral surface in the region of friction.Furthermore, it is also possible to do not possess friction to reduce layer 41b, 74b, in this case, outer tube The inner peripheral surface of portion 31 or conduit 70 is formed by basal layer 41a, 74a.
(other the invention extracted out from the respective embodiments described above)
From other invention of the respective embodiments described above extraction as shown below.
First other medical device:
It is characterized in that possessing:
Pipe portion, as the pore of path function when it is formed with use;
Axle portion, it is to arrange in the way of proximal side extension from this pipe portion, and is formed thinner than described pipe portion;
Junction surface, is arranged in the resin bed of the composition wall portion that its proximal side in described pipe portion is embedded in this pipe portion, and There is the metallic region that the metallic region with described axle portion is welded, by this welding, described axle portion is linked with described pipe portion;
Metal tubulation portion, it laterally more extends by amphi position side than junction surface closer to position from the distal end section than this junction surface Arrange, and rigidity is formed lower than this junction surface, be embedded in the resin bed constituting described wall portion in the range of extending.
According to this structure, it is possible to the opening of the peri position side in pipe portion is arranged in the axis direction in medical device Position on the way.And, by the welding at junction surface, axle portion being linked, the link for pipe portion that therefore can improve this axle portion is strong Degree.And, by from junction surface to extended metal tubulation portion, amphi position side, thus in the structure being provided with junction surface, can be real The raising of existing resistance to bend(ing).
Second other medical device: based on the first other medical device, it is characterised in that described joint Portion is formed as tubular around axle, and is being formed with the spiral around axle cincture from its distal end section on the regulation region of proximal side The slit of shape,
Described metal tubulation portion is with lower than the rigidity in the region being formed with described spiral helicine slit in described junction surface Mode be formed as coiled type.
According to this structure, it is possible to make rigidity reduce step by step towards amphi position side.
3rd other medical device: based on the medical device that first or second are other, it is characterised in that institute State junction surface and be formed as tubular around axle, and described axle portion is welded on the assigned position around axle at described junction surface,
The most described axle portion of the peri position end side in described pipe portion does not exist on the position around axle of side, resin bed to than Described junction surface extends closer to side, position, thus produces non-existent region, this junction surface,
Described metal tubulation portion enters in non-existent region, this junction surface.
According to this structure, in the opening part of the peri position side in pipe portion does not exposes the structure at junction surface, it is possible to pass through metal The intensity of the opening of this peri position side is improved in tubulation portion.
4th other medical device: in first to the 3rd in arbitrary other medical device, it is characterised in that Described axle portion is carried out relative to being welded under the state making this axle portion abut with the inner peripheral surface at described junction surface of described junction surface,
On the position around axle of side existing for described axle portion, the peri position end in described metal tubulation portion is than described axle portion more Exist by amphi position side.
According to this structure, it can be ensured that the opening of the peri position side in bigger pipe portion.

Claims (5)

1. a medical device, it possesses medical pipe portion, and this medical pipe portion is inserted in organism at least partially And there is pore as path function in use, described medical device is characterised by,
The first intensive aspect of tubulose is possessed, this first intensive aspect in the part being inserted in organism in described medical pipe portion Distal end section be positioned at the half-way of axis direction of this part and the most extended, and the scope extended at it The wall portion in interior composition described medical pipe portion,
In this first intensive aspect, from its distal end section, regulation region towards proximal side is formed than its firm closer to side, position Property reduce rigidity reduce region,
But also possess the second intensive aspect of tubulose, this second intensive aspect from than described first intensive aspect distal end section closer to The position of side, position is extended to the position more leaning on amphi position side than this first intensive aspect, and rigidity is formed as described first intensive aspect Described rigidity reduces below the rigidity in region, and constitutes described wall portion in the range of extending,
This second intensive aspect extends towards amphi position side in the pore of described first intensive aspect,
At least in the part being inserted in organism in described medical pipe portion, described first intensive aspect and described second is strengthened Body is embedded in resin bed,
The inner peripheral surface in described medical pipe portion is at least defined in the region being provided with described second intensive aspect by this resin bed, And the friction possessing the resin formation by friction lower than the resin portion of outer peripheral face side reduces layer,
The outer peripheral face that the inner peripheral surface of described second intensive aspect reduces layer with described friction connects,
Described second intensive aspect uses metal wire to be formed as coiled type,
And in described second intensive aspect at least to than described first intensive aspect more by amphi position side extend position, by institute State friction reduction layer and described resin bed reduce than described friction and inside and outside the basal layer that layer more outward side face side exists, clamp institute State the second intensive aspect, and described friction is reduced layer and basal layer link, and make resin enter edge in described second intensive aspect Between the metal line portions that axis direction is adjacent.
2. a medical device, it possesses medical pipe portion, and this medical pipe portion is inserted in organism at least partially And there is pore as path function in use, described medical device is characterised by,
The first intensive aspect of tubulose is possessed, this first intensive aspect in the part being inserted in organism in described medical pipe portion Distal end section be positioned at the half-way of axis direction of this part and the most extended, and the scope extended at it The wall portion in interior composition described medical pipe portion,
In this first intensive aspect, from its distal end section, regulation region towards proximal side is formed than its firm closer to side, position Property reduce rigidity reduce region,
But also possess the second intensive aspect of tubulose, this second intensive aspect from than described first intensive aspect distal end section closer to The position of side, position is extended to the position more leaning on amphi position side than this first intensive aspect, and rigidity is formed as described first intensive aspect Described rigidity reduces below the rigidity in region, and constitutes described wall portion in the range of extending,
This second intensive aspect extends towards amphi position side in the pore of described first intensive aspect,
At least in the part being inserted in organism in described medical pipe portion, described first intensive aspect and described second is strengthened Body is embedded in resin bed,
On region in described second intensive aspect enters into the pore of described first intensive aspect, at described first intensive aspect and The most sandwiched described resin bed between two intensive aspects.
Medical device the most according to claim 2, it is characterised in that
The inner peripheral surface in described medical pipe portion is at least defined in the region being provided with described second intensive aspect by this resin bed, And the friction possessing the resin formation by friction lower than the resin portion of outer peripheral face side reduces layer,
The outer peripheral face that the inner peripheral surface of described second intensive aspect reduces layer with described friction connects.
Medical device the most according to claim 3, it is characterised in that
Described second intensive aspect uses metal wire to be formed as coiled type,
And in described second intensive aspect at least to than described first intensive aspect more by amphi position side extend position, by institute State friction reduction layer and described resin bed reduce than described friction and inside and outside the basal layer that layer more outward side face side exists, clamp institute State the second intensive aspect, and described friction is reduced layer and basal layer link, and make resin enter edge in described second intensive aspect Between the metal line portions that axis direction is adjacent.
Medical device the most according to claim 2, it is characterised in that
Described second intensive aspect uses metal wire to be formed as coiled type,
This resin bed possesses and at least carries out the inner peripheral surface in described medical pipe portion in the region being provided with described second intensive aspect The interior perisphere limited,
The inner peripheral surface of described second intensive aspect connects with the outer peripheral face of described interior perisphere, and described in described second intensive aspect The region that first intensive aspect connects from outer circumferential side, between the most adjacent metal line portions in this second intensive aspect It is formed with the space part that resin is introduced into,
And in described second intensive aspect at least to than described first intensive aspect more by amphi position side extend position on, pass through The inside and outside clamping of basal layer that in described in ratio in described interior perisphere and described resin bed, perisphere more outward side face side exists described the Two intensive aspects, and described interior perisphere and basal layer are linked, and make resin enter in described second intensive aspect along axis side Between adjacent metal line portions.
CN201210038063.7A 2012-02-17 2012-02-17 Medical device Active CN103252014B (en)

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