CN103071230A - Controllable bent guiding catheter and manufacture method thereof - Google Patents

Abstract

The invention discloses a controllable bent guiding catheter and a manufacture method thereof, solving the technical problems of shortening operation time and increasing operation safety. The controllable bent guiding catheter is provided with a catheter, wherein a handle is connected to the near end of the catheter, the remote end of the catheter is provided with a catheter bending section, the catheter bending section is connected with the remote end of a metal pull wire, the near end of the metal pull wire is connected to the handle, and the handle is bent through controlling the catheter bending section by the metal pull wire. The manufacture method disclosed by the invention comprises the steps of: manufacturing an axial support combination member, manufacturing the catheter and assembling. Compared with the prior art, the controllable bent guiding catheter has the advantages that the relative positions of an external handle and a pull rod as well as the external handle and a push rod are regulated, the remote end of the catheter bending section is bent and deformed, the relative displacement of the external handle and the push rod is controlled, and the remote end of the catheter is bent controllably, so that one catheter can enter the left coronary artery and the right coronary artery, the operation time is shortened, and the safety of the coronary artery intervention operation is improved. The controllable bent guiding catheter is also suitable for hearts of different sizes and coronary arteries with different openings.

Description

Controllable bending guiding catheter and preparation method thereof

Technical field

The present invention relates to a kind of medical apparatus and instruments and preparation method thereof, particularly guiding catheter of a kind of interventional therapy and preparation method thereof.

Background information

Guiding catheter is the percutaneous coronary intervention (pci) requisite subsidiary conduit of performing the operation, by guiding catheter being sent into the coronary artery entrance, for seal wire, sacculus or support provide admission passage.Because patient's cardiac size and the shape of coronary ostium are incomplete same, in order to adapt to patient's different arteria coronaria tremulous pulsies, the far-end of guiding catheter is made multiple bending.The guiding catheter of prior art is fixing bending, its curved complexity, type is various, for selecting guiding catheter, the doctor brought inconvenience like this, the doctor needs to change the guiding catheter of multiple different bendings in operation process simultaneously, so not only prolong the time of operation, strengthened patient's misery, also increased the risk of operation.

Summary of the invention

The purpose of this invention is to provide a kind of controllable bending guiding catheter and preparation method thereof, the technical problem that solve is to shorten operating time, improves operation safety.

The present invention is by the following technical solutions: a kind of controllable bending guiding catheter, be provided with conduit, the near-end of conduit is connected with handle, the far-end of described conduit is the guiding-tube bend section, the far-end of guiding-tube bend section connection metal backguy, the near-end of metal backguy is connected on the handle, and handle is crooked through metal backguy control guiding-tube bend section.

The distal end of guiding-tube bend section of the present invention is equipped with the development indicating, and the near-end of development indicating is equipped with the becket anchor point, and the distance between becket anchor point and the development indicating is 4mm～30mm, and described metal backguy far-end and becket anchor point are welded to connect.

Guiding-tube bend section of the present invention is linearity in free state, and the angle that is bent is: 0＜angle≤270 °; Or described guiding-tube bend section is bending in free state, and crooked angle is: 0＜angle≤90 °, the angle that is bent is: 0＜angle≤270 °, the direction that is bent and guiding-tube bend section are at the opposite direction of free state bending.

The part of guiding-tube bend section of the present invention between development indicating and becket anchor point is bending in free state; Or the junction of described guiding-tube bend section 7 and thenon-bending section 6 of conduit, be bending in free state.

Conduit of the present invention is connected and composed by guiding-tube bend section and the non-bending section of conduit of far-end.

Guiding-tube bend section of the present invention and the non-bending section of conduit are provided with conduit internal layer, conduit intermediate layer and catheter outer, and catheter outer is nested with outside the conduit internal layer, and the conduit intermediate layer is embedded in the catheter outer; Described conduit internal layer adopts politef, the conduit intermediate layer is woven wire cloth, it is macromolecule polymer material block polyamide, nylon or the polyurethane of 25D～72D that catheter outer adopts hardness, the guiding-tube bend section adopts relatively soft macromolecule polymer material, and the non-bending section of conduit adopts the relatively high macromolecule polymer material of hardness; Described becket anchor point is embedded in the catheter outer.

Near-end one side of becket anchor point of the present invention, along the axial direction of conduit, being formed with the cross section in catheter outer is poroid backguy chamber; At the non-bending section of conduit, the backguy intracavity is provided with the axial support molectron, the metal backguy is arranged in the axial support molectron hole of the backguy chamber of guiding-tube bend section and the non-bending section of conduit: described axial support molectron is provided with internal layer, intermediate layer and skin, described internal layer adopts politef, the intermediate layer is the net of metal wire knitted or the coil spring shape of coiling, and skin is high molecular polymer polyimides, polyether-ether-ketone, nylon, block polyamide or polyurethane.

Handle of the present invention is provided with push rod and the outdoor handle of tubular, and the near-end of push rod puts in a section of outdoor handle through hole far-end vertically, is formed with damping and is slidingly connected; Be provided with anchorage shoe in one section of described outdoor handle through hole near-end, the near-end of described metal backguy is connected on the anchorage shoe.

Have stopper slot on the excircle of push rod of the present invention, the length direction of stopper slot is parallel to the axis direction of push rod; Radially have pin-and-hole on the described outdoor handle, insert the limited location pin in the pin-and-hole, spacer pin inwardly stretches out in one section insertion stopper slot of pin-and-hole.

A kind of preparation method of controllable bending guiding catheter may further comprise the steps:

One, make the axial support molectron,

Internal layer adopts politef, and internal diameter is 0.25mm～2.5mm, thick 0.02mm～0.1mm, and length is 40cm～130cm;

It is stainless steel silk, tungsten filament, cochrome silk, titanium alloy wire or the nitinol alloy wire of 0.01mm～0.1mm that string diameter is adopted in the intermediate layer, the silk number is 8～32, be woven into the net of 30～200PPI, or rotating speed is 5 ~ 20r/min, turning to external diameter is 0.3mm～3.0mm, and pitch is the coil spring shape of 0.02mm～0.2mm;

Outer high molecular polymer polyimides, polyether-ether-ketone, nylon, block polyamide or the polyurethane of adopting, external diameter is 0.4mm～3.1mm;

Being nested with at external diameter by level internal layer, intermediate layer, skin is 0.25mm～2.5mm, length is on the metal or plastics plug of 40cm～130cm, putting outside internal diameter is 1.0 ~ 3.0mm, shrinkage ratio is the fluorinated ethylene propylene copolymer heat-shrinkable tube of 1.3:1 ~ 2:1, rheological temperature 380 ~ 450 ℉, rheology speed 0.08 ~ 0.25cm/s, naturally cool to room temperature after, peel heat-shrinkable tube off, extract the making that plug is finished the axial support molectron;

Two, make conduit,

The conduit internal layer adopts polyfluortetraethylene pipe, and internal diameter is 0.6mm～6.0mm, thick 0.02mm～0.1mm, long 600mm～1450mm;

It directly is 0.02mm～0.1mm stainless steel silk or nitinol alloy wire that 8～32 rhizoids are adopted in the conduit intermediate layer, is woven into the wire netting of 30PPI～100PPI;

It is macromolecule polymer material block polyamide, nylon or the polyurethane tube of 25D～72D that catheter outer adopts hardness, and external diameter is 1mm～7mm, and the guiding-tube bend section adopts relatively soft polymer pipe, long 10mm～100mm; The non-bending section of conduit adopts the relatively high polymer pipe of hardness, long 600mm～1400mm;

Developing mark adopts the macromolecular material of platinumiridio, platinum, gold, tantalum, tungsten, tungstenic or contains Bi₂O₃The macromolecular material ring, be of a size of 0.6mm～6.0mm;

The becket anchor point adopts rustless steel, Nitinol or platinumiridio ring, is of a size of 0.6mm～6.0mm;

It is stainless steel silk or the nitinol alloy wire of 0.1mm～0.5mm that string diameter is adopted in the metal backguy, long 700mm～1600mm; One end of metal backguy is welded on the becket anchor point, and welding current is 75A～200A, and pulsewidth is 2ms～10ms, and the other end of metal backguy passes the axial support molectron;

(1) being nested with the conduit internal layer at external diameter is 0.6mm～6.0mm, and length is 600mm～1450mm, along on the reeded metal mandrel of axis band; (2) in order from far-end, with developing mark, be nested with the position that is positioned at the guiding-tube bend section at the conduit internal layer with the becket anchor point of metal backguy, the distance between developing mark and the becket anchor point is 4mm～30mm; (3) the axial support molectron is arranged on vertically the groove location of metal mandrel of the non-bending section of conduit of conduit internal layer; (4) the conduit intermediate layer is nested with outside becket anchor point and axial support molectron; (5) be nested with catheter outer outside the conduit intermediate layer, the catheter outer of long 10mm～100mm is nested with at far-end; (6) putting internal diameter outside catheter outer is 1.3 ~ 9.5mm, and shrinkage ratio is the fluorinated ethylene propylene copolymer heat-shrinkable tube of 1.3 ~ 2:1, rheological temperature 380 ~ 450 ℉, rheology speed 0.08 ~ 0.25cm/s, naturally cool to room temperature after, peel heat-shrinkable tube off, extract plug, obtain conduit;

Three, push rod, outdoor handle, spacer pin, anchorage shoe adopt the medical stainless steel material, press the existing machinery processing method and make;

Four, assembling obtains the controllable bending guiding catheter.

The present invention compared with prior art, regulate the relative position of outdoor handle and pulling-pushing rod, the metal backguy screw lock that is fixed, be equivalent to loosen or strain the metal backguy, the far-end of guiding-tube bend section occurs bending and deformation, the relative displacement of control outdoor handle and push rod, can control the degree of crook of guiding-tube bend section far-end, realize that the distal end of catheter bending is controlled, reach and use same conduit can enter a left side, right coronary artery, shorten operating time, alleviate the patient suffering, improve the safety of percutaneous coronary intervention operation, also be fit to the heart of different sizes and the coronary artery of different openings, compact conformation, cost is low.

Description of drawings

The structural representation of Fig. 1 embodiment of the invention.

Fig. 2 is that the guiding-tube bend section of the embodiment of the invention is bent rear schematic diagram ().

Fig. 3 is the guiding-tube bend section free state schematic diagram () of the embodiment of the invention.

Fig. 4 is the guiding-tube bend section free state schematic diagram (two) of the embodiment of the invention.

Fig. 5 is the guiding-tube bend section of the embodiment of the invention and the structural representation of the non-bending section of conduit.

Fig. 6 is the A-A cutaway view of Fig. 5.

Fig. 7 is the B-B profile of Fig. 2.

Fig. 8 is the structural representation of the axial support molectron of the embodiment of the invention.

Fig. 9 is the handle arrangement schematic diagram of the embodiment of the invention.

The specific embodiment

Below in conjunction with drawings and Examples the present invention is described in further detail.Each Reference numeral is in Figure of description: controllable bending guiding catheter 1, catheter adapter 2, outdoor handle 3, push rod 4, hold-downscrew 5, thenon-bending section 6 of conduit, guiding-tube bend section 7,metal backguy 8, development indicating 9,becket anchor point 10, conduitinternal layer 11, conduitintermediate layer 12, catheter outer 13,axial support molectron 14,backguy chamber 15,catheter lumen 16, axial support molectroninternal layer 17, axial support molectronintermediate layer 18, axialsupport molectron skin 19, push rodinner chamber 20,stopper slot 21,damped ring 22, spacer pin 23, throughhole 24,anchorage shoe 25,catheter channel 26,backguy passage 27.

As shown in Figure 1, controllable bending guiding catheter 1 of the present invention, from near-end to far-end, being linked in sequence by catheter adapter 2, handle and conduit consists of.Conduit is tubulose, length is 600mm～1450mm, and internal diameter is 0.6mm～6.0mm, and external diameter is 1mm～7mm, connected and composed bynon-bending section 6 two parts of the guiding-tube bend section 7 that is positioned at one section of far-end and the conduit that is connected with guiding-tube bend section 7, guiding-tube bend section 7 length are 20mm～100mm.The distal end of guiding-tube bend section 7 is equipped with development indicating 9, is equipped withbecket anchor point 10 near near-end one side of development indicating 9.Be provided withmetal backguy 8 in the conduit,metal backguy 8 far-ends andbecket anchor point 10 are welded to connect, and near-end is fixedly connected on the handle.

As shown in Figure 2, guiding-tube bend section 7 is linearity in free state, and the far-end of guiding-tube bend section 7 can operate control by the doctor and be bent, and the angle that is bent is: 0＜angle≤270 °.

As shown in Figure 3, the part of guiding-tube bend section 7 between development indicating 9 andbecket anchor point 10, be bending in free state, bending is 90 °, can be 0＜angle≤90 °, the angle that is bent is: 0＜angle≤270 °, the direction that is bent and guiding-tube bend section 7 are at the opposite direction of free state bending.

As shown in Figure 4, in the junction of guiding-tube bend section 7 and thenon-bending section 6 of conduit, be bending in free state, bending is 90 °, can be 0＜angle≤90 °, the angle that is bent is: 0＜angle≤270 °, the direction that is bent and guiding-tube bend section 7 are at the opposite direction of free state bending.

As shown in Figure 5, the non-bending section of guiding-tube bend section 7 andconduit 6 is made of three-decker, is respectively conduitinternal layer 11, conduitintermediate layer 12 and catheter outer 13, and catheter outer 13 is nested with outside conduitinternal layer 11, and conduitintermediate layer 12 is embedded in the catheter outer 13.Conduitinternal layer 11 adopts politef, makes conduit have smoothinner chamber 16, and conduitinternal layer 11 internal diameters are 0.6mm～6.0mm, thick 0.02mm～0.1mm.Conduitintermediate layer 12 is tinsel rustless steel or nitinol alloy wire mesh grid, and string diameter is 0.02mm～0.1mm, and density is 30PPI～100PPI(per inch order number), woven wire cloth makes conduit have good fracture resistance.It is macromolecule polymer material block polyamide, nylon or the polyurethane of 25D～72D that catheter outer 13 adopts hardness, consists of respectively thenon-bending section 6 of guiding-tube bend section 7 and conduit.Guiding-tube bend section 7 adopts relatively soft macromolecule polymer material, is 25D such as hardness, and thenon-bending section 6 of conduit adopts the relatively high macromolecule polymer material of hardness, is 72D such as hardness.The external diameter of catheter outer 13 is 1mm～7mm.Development indicating 9 adopt ring-types platinumiridio, platinum, gold, tantalum, tungsten, tungstenic macromolecular material or contain Bi₂O₃Macromolecular material.Becketanchor point 10 is rustless steel, Nitinol or platinumiridio ring.Development indicating 9 is embedded in the catheter outer 13 of guiding-tube bend section 7 distal ends, andbecket anchor point 10 is embedded near the catheter outer 13 of development indicating 9 near-ends one side, and the distance betweenbecket anchor point 10 and the development indicating 9 is 4mm～30mm.Near-end one side atbecket anchor point 10 begins, along the axial direction of conduit, between conduitinternal layer 11 and the conduitintermediate layer 12, be formed with thebackguy chamber 15 that the cross section is circular hole in the catheter outer 13.At thenon-bending section 6 of conduit, be provided withaxial support molectron 14 in the backguy chamber 15.The far-end ofmetal backguy 8 is welded to connect onbecket anchor point 10, andmetal backguy 8 is through thebackguy chamber 15 of guiding-tube bend section 7,axial support molectron 14 endoporus of thenon-bending section 6 of conduit, and near-end is connected with outdoor handle 3.When can absorbingmetal backguy 8 stretching,axial support assembly 14 tonon-bending section 6 axial compressive forces, avoid thenon-bending section 6 of conduit to occur bending and deformation.The near-end of thenon-bending section 6 of conduit has mouth, is used formetal backguy 8 and stretches out fromnon-bending section 6 near-ends of conduit.

As shown in Figure 6, thecylindrical cavity 16 that conduitinternal layer 11 forms, along axis one sidewall to the center of circle in evagination, form the depression in the face of catheter outer 13, catheter outer 13 is to the recess evagination, the cross section be thatcircular backguy chamber 15 is at evagination and between caving in.As shown in Figure 7,axial support molectron 14 is embedded in thebackguy chamber 15 of thenon-bending section 6 of conduit.The structure ofbackguy chamber 15 between evagination and depression be not so that in guiding-tube bend section 7 controlled being bent, increase the wall thickness of conduit integral body.

As shown in Figure 8,axial support molectron 14 is nested with by three-decker and consists of, and is respectivelyinternal layer 17,intermediate layer 18 and outer 19.Internal layer 17 adopts politef, and internal diameter is 0.25mm～2.5mm, thick 0.02mm～0.1mm.Intermediate layer 18 is tinsel stainless steel silk, tungsten filament, cochrome silk, titanium alloy wire or the net of nitinol alloy wire braiding or the coil spring shape of coiling.String diameter wiry is 0.01mm～0.1mm, and the density of mesh grid is 30PPI～200PPI, and the coil spring shape external diameter is 0.3mm～3.0mm, and pitch is 0.02mm～0.2mm.Outer 19 is high molecular polymer polyimides, polyether-ether-ketone, nylon, block polyamide or polyurethane, and external diameter is 0.4mm～3.1mm.The internal diameter ofaxial support molectron 14 can guarantee that greater than the external diameter ofmetal backguy 8 the smooth and easy ofmetal backguy 8 passes through.

It is stainless steel silk or the nitinol alloy wire of 0.1mm～0.5mm that string diameter is adopted inmetal backguy 8.

As shown in Figure 9, handle is provided with push rod 4 and outdoor handle 3, and push rod 4 and outdoor handle 3 forms being slidingly connected vertically.The near-end of push rod 4 puts in a section of outdoor handle 3 through hole far-end vertically.Push rod 4 is shaped as cylindric, and thenon-curved segment 6 of conduit is passed push rod 4 along the inner chamber (endoporus) 20 of axis, is fixed on the push rod 4.

Form the projection in an outside week on the excircle of the far-end of push rod 4 by machining, projection is used for conveniently releasing or drawing in when the doctor operates push rod 4.Middle part and near-end excircle at push rod 4 have two cannelures, be used for to embeddamped ring 22, increase the damping between push rod 4 and outdoor handle 3 endoporus, prevent in the process that guiding-tube bend section 7 is bent, and push rod 4 moves to proximal direction.Between the outer surface of push rod 4, two cannelures, have thestopper slot 21 of a rectangular shape, the length direction ofrectangle stopper slot 21 is parallel to the axis direction of push rod 4, one section insertion that the spacer pin 23 that is used for connecting on the outdoor handle 3 inwardly stretches out outdoor handle 3 pin-and-holes wherein, make the spacer pin 23 can be interior movable along its length direction atstopper slot 21, the stroke that restriction push rod 4 moves relative to outdoor handle 3 axis.

Outdoor handle 3 is shaped as cylindric, in the distal portions of outdoor handle 3, the position that push rod 4 stretches into its through hole, radially has pin-and-hole on the wall of cylinder, is used for inserting spacer pin 23, and spacer pin 23 inwardly stretches out in one sectioninsertion stopper slot 21 of pin-and-hole.The proximal part of outdoor handle 3 is provided with ananchorage shoe 25 in the through hole,anchorage shoe 25 forms dismountable the connection with outdoor handle 3 in through hole, as be threaded, the built-in collar in two ends or boss cooperate with built-in collar.Anchorageshoe 25 is shaped as column, is provided with two passages (through hole) along its axis onanchorage shoe 25, is respectively and thecatheter channel 26 of outdoor handle 3 axis coaxles and thebackguy passage 27 parallel with outdoor handle 3 axis.Lateral wall at thebackguy passage 27 of outdoor handle 3 walls andanchorage shoe 25, along outdoor handle 3 radially, have screw, be used for screwing in hold-downscrew 5, have the throughhole 24 vertical with hold-downscrew 5 axis near the end of hold-downscrew 5, when hold-downscrew 5 screwed in the screw of outdoor handle 3 andanchorage shoe 25, throughhole 24 was communicated with backguy passage 27.The near-end of thenon-bending section 6 of conduit stretches out outdoor handle 3 through inner chamber, thecatheter channel 26 of push rod 4, is connected with catheter adapter 2.Metal backguy 8 is stretched out from the proximal openings of thenon-bending section 6 of conduit, throughbackguy passage 27 and pass the throughhole 24 of hold-down screw 5.Hold-downscrew 5 is rotated a certain angle can be withmetal backguy 8 fixing and lockings on outdoor handle 3.

The female Luer of standard is adopted in catheter adapter 2.

When the doctor performs the operation, one holds outdoor handle 3, another hands forward (far-end) pushes away or (near-end) pulling-pushing rod 4 backward, because ofscrew 5 lockings that are fixed of the near-end ofmetal backguy 8, be equivalent to loosen orstrain metal backguy 8, thenon-bending section 6 of conduit does not produce waveform or arc-shaped bend, the far-end of guiding-tube bend section 7 occurs bending and deformation, the relative displacement of control outdoor handle 3 and push rod 4, can control the degree of crook of guiding-tube bend section 7 far-ends, realize that the distal end of catheter bending is controlled, reach and use same conduit can enter a left side, right coronary artery shortens operating time, alleviates the patient suffering, improve the safety of percutaneous coronary intervention operation, also be fit to the heart of different sizes and the coronary artery of different openings.The wall thickness of the not obvious increase conduit of controllable bending guiding catheter of the present invention, compact conformation, cost is low.

The preparation method of controllable bending guiding catheter of the present invention may further comprise the steps:

One, make the axial support molectron,

Internal layer adopts politef, and internal diameter is 0.25mm～2.5mm, thick 0.02mm～0.1mm, and length is 40cm～130cm.

It is stainless steel silk, tungsten filament, cochrome silk, titanium alloy wire or the nitinol alloy wire of 0.01mm～0.1mm that intermediate layer material adopts string diameter, the silk number is 8～32, be woven into the net of 30～200PPI, the braider that adopts Grand Technology (Shenzhen) Co., Ltd. to make, rotating speed 70 ~ 180r/min.Or employing U.S. RothGreaves﹠amp; The L80 coiling machine of Associates Inc company, rotating speed is 5 ~ 20r/min, and turning to external diameter is 0.3mm～3.0mm, and pitch is the coil spring shape of 0.02mm～0.2mm.

Cladding material is high molecular polymer polyimides, polyether-ether-ketone, nylon, block polyamide or polyurethane, and external diameter is 0.4mm～3.1mm.

Being nested with at external diameter by level internal layer, intermediate layer, skin is 0.25mm～2.5mm, length is on the metal or plastics plug of 40cm～130cm, putting outside internal diameter is 1.0 ~ 3.0mm, shrinkage ratio is the fluorinated ethylene propylene copolymer FEP heat-shrinkable tube of 1.3:1 ~ 2:1, Reflow-22 03-44 type rheology machine with U.S. USA AT INC company fuses together the three, rheological temperature 380 ~ 450 ℉, rheology speed 0.08 ~ 0.25cm/s, after naturally cooling to room temperature, peel heat-shrinkable tube off, extract the making that plug is finishedaxial support molectron 14.

Two, make conduit,

The conduit internal layer adopts polyfluortetraethylene pipe, and internal diameter is 0.6mm～6.0mm, thick 0.02mm～0.1mm, long 600mm～1450mm.

It directly is 0.02mm～0.1mm stainless steel silk or nitinol alloy wire that 8～32 rhizoids are adopted in the conduit intermediate layer, is woven into the wire netting of 30PPI～100PPI, with the braider of Grand Technology (Shenzhen) Co., Ltd., rotating speed 70 ~ 180r/min.

It is macromolecule polymer material block polyamide, nylon or the polyurethane tube of 25D～72D that catheter outer adopts hardness, and external diameter is 1mm～7mm.The guiding-tube bend section adopts relatively soft polymer pipe, is 25D such as hardness, long 10mm～100mm.The non-bending section of conduit adopts the relatively high polymer pipe of hardness, is 72D such as hardness, long 600mm～1400mm.

Developing mark adopts the village, Hong Kong to believe the macromolecular material of the platinumiridio of ten thousand rich noble metal company limiteies, platinum, gold, tantalum, tungsten, tungstenic or contains Bi₂O₃The macromolecular material ring, be of a size of 0.6mm～6.0mm.

The becket anchor point adopts rustless steel, Nitinol or the platinumiridio ring of Yangzhou brocade instrument precision tube company limited, is of a size of 0.6mm～6.0mm.

It is stainless steel silk or the nitinol alloy wire of 0.1mm～0.5mm that string diameter is adopted in the metal backguy, long 700mm～1600mm.One end of metal backguy is welded on the becket anchor point, adopts the laser-beam welding machine of Wuhan sky above Hubei and Hunan industrial lasers equipment company limited, welding current is 75A～200A, and pulsewidth is 2ms～10ms, and the other end of metal backguy passes the axial support molectron.

(1) being nested with the conduit internal layer at external diameter is 0.6mm～6.0mm, and length is 600mm～1450mm, along on the reeded metal mandrel of axis band.(2) in order from far-end, with developing mark, be nested with the position that is positioned at the guiding-tube bend section at the conduit internal layer with the becket anchor point of metal backguy, the distance between developing mark and the becket anchor point is 4mm～30mm.(3) the axial support molectron is arranged on vertically the groove location of metal mandrel of the non-bending section of conduit of conduit internal layer.(4) the conduit intermediate layer is nested with outside becket anchor point and axial support molectron.(5) be nested with catheter outer outside the conduit intermediate layer, the catheter outer of long 10mm～100mm is nested with at far-end.(6) putting internal diameter outside catheter outer is 1.3 ~ 9.5mm, shrinkage ratio is the fluorinated ethylene propylene copolymer FEP heat-shrinkable tube of 1.3 ~ 2:1, Reflow-22 03-44 type rheology machine with U.S. USA AT INC company fuses together each layer of conduit, rheological temperature 380 ~ 450 ℉, rheology speed 0.08 ~ 0.25cm/s, naturally cool to room temperature after, peel heat-shrinkable tube off, extract plug, obtain conduit.

Three, push rod, outdoor handle, spacer pin, anchorage shoe and hold-down screw adopt the medical stainless steel material, press the existing machinery processing method and make.Catheter adapter is the standard Luer joint of outsourcing.

Four, assembling, catheter proximal end is packed into from the hole of push rod far-end and stretch out push rod, with AB glue conduit and push rod are adhesively fixed, with pack into the through hole (inner chamber) of outdoor handle near-end of anchorage shoe, to stretch out the conduit of push rod by the catheter channel of anchorage shoe, the metal backguy is by the backguy passage of anchorage shoe simultaneously, and pass through hole on the hold-down screw, the outdoor handle near-end is begun to be nested with on push rod from the push rod far-end, spacer pin inserts and puts in stopper slot from the pin-and-hole of outdoor handle, and the rotary fixing screw nail can the fixing metal backguy.With AB glue that catheter proximal end and catheter adapter is bonding at the catheter proximal end that stretches out outdoor handle.AB glue is the happy safe epoxy AB glue of M-31CL.

Embodiment, the external diameter of controllable bending guiding catheter is 2.33mm, and effective length (conduit exposes the length of handle) is 1000mm, and the guiding-tube bend section is 90 ° of bendings under free state, the non-bending section of conduit linear state under free state, the maximum bend angle of distal end of catheter is 270 °.

Animal experiment, select one of 20 kilograms of dog of body weight, this dog left and right sides coronary stenosis, adopt the controllable bending guiding catheter of the present embodiment and supporting convergent divergent channel, 2.0mm * 20mm PTCA(Percutenous transluminal coro-nary angioplasty Percutaneous transluminal coronary angioplasty) foley's tube and adapted seal wire (0.014 "; 195cm), ultrahard guide wire (0.035 ", 260cm), puncture sheath, Y-shaped connector accessory one cover.Femoral artery puncture is sent ultrahard guide wire near the position arteria coronaria entrance; Convergent divergent channel is inserted from the joint of controllable bending guiding catheter, watch the development indicating of controllable bending guiding catheter, the combination of convergent divergent channel and controllable bending guiding catheter is sent near the position arteria coronaria entrance along superhard seal wire; Withdraw from ultrahard guide wire and convergent divergent channel, joint at the controllable bending guiding catheter connects a Y-shaped connector, adjust the position of conduit in blood vessel, make dorsad arteria coronaria entrance of 90 ° of bending sections of far-end, because the far-end of backguy is fixed on distal end of catheter by the becket anchor point, near-end is fixed on the outdoor handle with hold-down screw by anchorage shoe, when the palm of the hand is held outdoor handle, thumb pushes to (front) far away end, or to nearly (afterwards) end pulling-pushing rod, can change the degree of crook of the guiding-tube bend section of distal end of catheter, thumb pushes push rod forward to highest distance position, and the spacer pin on the outdoor handle slides into the near-end of push rod stopper slot at this moment, and the curved distal tune is maximum 270 ° of bendings, the push rod of slowly pulling back makes the remote port of conduit enter to the arteria coronaria entrance; Inject contrast agent to arteria coronaria from the side opening of Y-shaped connector through the controllable bending guiding catheter, confirm the coronary stenosis position; With 0.014 ", the 195cm seal wire enters from the positive hole of Y-shaped connector, enters arteria coronaria and passes the angiostenosis position along the controllable bending guiding catheter; With the PTCA foley's tube along 0.014 ", the 195cm seal wire enters into the coronary stenosis position, and makes the developing mark at sacculus two ends be positioned at the two ends of narrow location, Filled Balloon is expanded the angiostenosis position; Expand complete after-contraction sacculus, with the PTCA foley's tube together with 0.014 ", the 195cm seal wire is together withdrawn from; The twisting push rod rotates a certain angle the controllable bending guiding catheter, and make according to the method described above the controllable bending guiding catheter make it enter to another arteria coronaria entry position, reenter according to the method described above 0.014 ", 195cm seal wire and PTCA foley's tube also carry out balloon expandable to the angiostenosis position; Expand and foley's tube is shunk after complete and retreat to the controllable bending guiding catheter, and connect the controllable bending guiding catheter and together withdraw from external.Observe the blood circumstance of previous angiostenosis position by angiographic method, blood flow is unobstructed, finishes the operation process of this coronary stenosis balloon expandable.

In the present embodiment, controllable bending guiding catheter of the present invention be used for to cooperate the balloon expandable operation, needs other apparatuses such as support, seal wire, sacculus are sent to arteria coronaria easily in diagnosis or treatment, all can adopt controllable bending guiding catheter of the present invention.

Claims (10)

1. controllable bending guiding catheter, be provided with conduit, the near-end of conduit is connected with handle, it is characterized in that: the far-end of described conduit is guiding-tube bend section (7), the far-end of guiding-tube bend section (7) connection metal backguy (8), the near-end of metal backguy (8) is connected on the handle, and handle is through the bending of metal backguy (8) control guiding-tube bend section (7).

2. controllable bending guiding catheter according to claim 1, it is characterized in that: the distal end of described guiding-tube bend section (7) is equipped with development indicating (9), the near-end of development indicating (9) is equipped with becket anchor point (10), distance between becket anchor point (10) and the development indicating (9) is 4mm～30mm, and described metal backguy (8) far-end and becket anchor point (10) are welded to connect.

3. controllable bending guiding catheter according to claim 2, it is characterized in that: described guiding-tube bend section (7) is linearity in free state, and the angle that is bent is: 0＜angle≤270 °; Or described guiding-tube bend section (7) is bending in free state, and crooked angle is: 0＜angle≤90 °, the angle that is bent is: 0＜angle≤270 °, the direction that is bent and guiding-tube bend section (7) are at the opposite direction of free state bending.

4. controllable bending guiding catheter according to claim 3, it is characterized in that: the part of described guiding-tube bend section (7) between development indicating (9) and becket anchor point (10) is bending in free state; Or the junction of described guiding-tube bend section 7 and the non-bending section 6 of conduit, be bending in free state.

5. controllable bending guiding catheter according to claim 1, it is characterized in that: described conduit is connected and composed by guiding-tube bend section (7) and the non-bending section of conduit (6) of far-end.

6. controllable bending guiding catheter according to claim 5, it is characterized in that: described guiding-tube bend section (7) and the non-bending section of conduit (6) are provided with conduit internal layer (11), conduit intermediate layer (12) and catheter outer (13), catheter outer (13) is nested with outside conduit internal layer (11), and conduit intermediate layer (12) are embedded in the catheter outer (13); Described conduit internal layer (11) adopts politef, conduit intermediate layer (12) is woven wire cloth, it is macromolecule polymer material block polyamide, nylon or the polyurethane of 25D～72D that catheter outer (13) adopts hardness, guiding-tube bend section (7) adopts relatively soft macromolecule polymer material, and the non-bending section of conduit (6) adopts the relatively high macromolecule polymer material of hardness; Described becket anchor point (10) is embedded in the catheter outer (13).

7. controllable bending guiding catheter according to claim 6 is characterized in that: near-end one side of described becket anchor point (10), and along the axial direction of conduit, being formed with the cross section in catheter outer (13) is poroid backguy chamber (15); At the non-bending section of conduit (6), be provided with axial support molectron (14) in the backguy chamber (15), metal backguy (8) is arranged in axial support molectron (14) hole of the backguy chamber (15) of guiding-tube bend section (7) and the non-bending section of conduit (6): described axial support molectron (14) is provided with internal layer (17), intermediate layer (18) and outer (19), described internal layer (17) adopts politef, intermediate layer (18) is the net of metal wire knitted or the coil spring shape of coiling, and outer (19) are the high molecular polymer polyimides, polyether-ether-ketone, nylon, block polyamide or polyurethane.

8. controllable bending guiding catheter according to claim 1, it is characterized in that: described handle is provided with push rod (4) and the outdoor handle (3) of tubular, the near-end of push rod (4) puts in a section of outdoor handle (3) through hole far-end vertically, is formed with damping and is slidingly connected; Be provided with anchorage shoe (25) in one section of described outdoor handle (3) through hole near-end, the near-end of described metal backguy (8) is connected on the anchorage shoe (25).

9. controllable bending guiding catheter according to claim 8, it is characterized in that: have stopper slot (21) on the excircle of described push rod (4), the length direction of stopper slot (21) is parallel to the axis direction of push rod (4); Described outdoor handle radially has pin-and-hole on (3), inserts limited location pin (23) in the pin-and-hole, and spacer pin (23) inwardly stretches out in one section insertion stopper slot (21) of pin-and-hole.

10. the preparation method of a controllable bending guiding catheter may further comprise the steps:

One, make the axial support molectron,

Internal layer adopts politef, and internal diameter is 0.25mm～2.5mm, thick 0.02mm～0.1mm, and length is 40cm～130cm;

It is stainless steel silk, tungsten filament, cochrome silk, titanium alloy wire or the nitinol alloy wire of 0.01mm～0.1mm that string diameter is adopted in the intermediate layer, the silk number is 8～32, be woven into the net of 30～200PPI, or rotating speed is 5 ~ 20r/min, turning to external diameter is 0.3mm～3.0mm, and pitch is the coil spring shape of 0.02mm～0.2mm;

Outer high molecular polymer polyimides, polyether-ether-ketone, nylon, block polyamide or the polyurethane of adopting, external diameter is 0.4mm～3.1mm;

Being nested with at external diameter by level internal layer, intermediate layer, skin is 0.25mm～2.5mm, length is on the metal or plastics plug of 40cm～130cm, putting outside internal diameter is 1.0 ~ 3.0mm, shrinkage ratio is the fluorinated ethylene propylene copolymer heat-shrinkable tube of 1.3:1 ~ 2:1, rheological temperature 380 ~ 450 ℉, rheology speed 0.08 ~ 0.25cm/s, naturally cool to room temperature after, peel heat-shrinkable tube off, extract the making that plug is finished the axial support molectron;

Two, make conduit,

The conduit internal layer adopts polyfluortetraethylene pipe, and internal diameter is 0.6mm～6.0mm, thick 0.02mm～0.1mm, long 600mm～1450mm;

It directly is 0.02mm～0.1mm stainless steel silk or nitinol alloy wire that 8～32 rhizoids are adopted in the conduit intermediate layer, is woven into the wire netting of 30PPI～100PPI;

It is macromolecule polymer material block polyamide, nylon or the polyurethane tube of 25D～72D that catheter outer adopts hardness, and external diameter is 1mm～7mm, and the guiding-tube bend section adopts relatively soft polymer pipe, long 10mm～100mm; The non-bending section of conduit adopts the relatively high polymer pipe of hardness, long 600mm～1400mm;

Developing mark adopts the macromolecular material of platinumiridio, platinum, gold, tantalum, tungsten, tungstenic or contains Bi₂O₃The macromolecular material ring, be of a size of 0.6mm～6.0mm;

The becket anchor point adopts rustless steel, Nitinol or platinumiridio ring, is of a size of 0.6mm～6.0mm;

It is stainless steel silk or the nitinol alloy wire of 0.1mm～0.5mm that string diameter is adopted in the metal backguy, long 700mm～1600mm; One end of metal backguy is welded on the becket anchor point, and welding current is 75A～200A, and pulsewidth is 2ms～10ms, and the other end of metal backguy passes the axial support molectron;

(1) being nested with the conduit internal layer at external diameter is 0.6mm～6.0mm, and length is 600mm～1450mm, along on the reeded metal mandrel of axis band; (2) in order from far-end, with developing mark, be nested with the position that is positioned at the guiding-tube bend section at the conduit internal layer with the becket anchor point of metal backguy, the distance between developing mark and the becket anchor point is 4mm～30mm; (3) the axial support molectron is arranged on vertically the groove location of metal mandrel of the non-bending section of conduit of conduit internal layer; (4) the conduit intermediate layer is nested with outside becket anchor point and axial support molectron; (5) be nested with catheter outer outside the conduit intermediate layer, the catheter outer of long 10mm～100mm is nested with at far-end; (6) putting internal diameter outside catheter outer is 1.3 ~ 9.5mm, and shrinkage ratio is the fluorinated ethylene propylene copolymer heat-shrinkable tube of 1.3 ~ 2:1, rheological temperature 380 ~ 450 ℉, rheology speed 0.08 ~ 0.25cm/s, naturally cool to room temperature after, peel heat-shrinkable tube off, extract plug, obtain conduit;

Three, push rod, outdoor handle, spacer pin, anchorage shoe adopt the medical stainless steel material, press the existing machinery processing method and make;

Four, assembling obtains the controllable bending guiding catheter.

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