CN203090196U - Balloon catheter - Google Patents

Balloon catheter Download PDF

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Publication number
CN203090196U
CN203090196U CN 201320042948 CN201320042948U CN203090196U CN 203090196 U CN203090196 U CN 203090196U CN 201320042948 CN201320042948 CN 201320042948 CN 201320042948 U CN201320042948 U CN 201320042948U CN 203090196 U CN203090196 U CN 203090196U
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China
Prior art keywords
far
sacculus
pin
diameter
foley
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CN 201320042948
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Chinese (zh)
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许寿贤
徐智浩
董超
蒋翠兰
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ORBUSNEICH MEDICAL APPLIANCE (SHENZHEN) CO Ltd
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ORBUSNEICH MEDICAL APPLIANCE (SHENZHEN) CO Ltd
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Abstract

The utility model discloses a balloon catheter. The balloon catheter aims to improve pushing ability and traversing ability of the balloon catheter and reduce damage on blood vessels. A balloon passes through a far end outer pipe and a near end pipe body and reaches a needle seat to form a pressure cavity, the far end of the balloon is connected with the tip end of a catheter, and the tip end of the catheter is 0.40mm to 1.14mm in outer diameter and 0.26mm to 0.95mm in inner diameter. The far end outer pipe is made of nylon or nylon elastic bodies, and the near end pipe body is made of stainless steel or nickel-titanium shape memory alloy. An inner pipe is arranged in the pressure cavity, the far end of the inner pipe is connected with the tip end of the catheter, and the near end of the inner pipe is a fast changing port of a guide wire. Compared with the prior art, by arranging the tip end of the catheter, toughness of the far end of the balloon catheter is good, performance of the balloon catheter for fitting the guide wire is good, when the balloon catheter is used for dealing with complex lesions such as bending lesion blood vessels and chronic total occlusion lesion blood vessels, ability for traversing the lesion blood vessels is high, damage easily generated on the blood vessels is reduced, and cost of an operation is lowered.

Description

Foley's tube
Technical field
This utility model relates to a kind of medical apparatus and instruments, particularly a kind of conduit of expanding the various pipelines of tissue.
Background technology
Since the operation of endothelium tube chamber angiography of coronary arteries, interventional therapy method obtained development fast in the blood vessel from 1977 first examples.Compare with the non-chronic pathological changes of entirely shutting, the chronic disease surgery success rate of entirely shutting is relatively low, the eighties to the mid-90, success rate of operation only is 48-76%.And along with the appearance of progress, the application of intravascular ultrasound IVUS, the empirical continuous accumulation of patient and the little sacculus of the updating of guiding wire structure, seal wire control method, from the later stage nineties so far, the success rate of operation of the chronic pathological changes of entirely shutting increases to 65-92%.When the success rate of the chronic disease surgery that entirely shuts improved gradually, operating equipment comprised that the availability of foley's tube will become the problem of patient and patient's concern.The appearance of little sacculus has also improved the phenomenon that may need follow-up balloon expandable when microtubular is handled similar pathological changes to a great extent.But the corresponding pathological changes of conventional process need be used the foley's tube of many different-diameters, uses less foley's tube to carry out pre-expansion earlier, selects larger-diameter foley's tube to carry out the back according to the size of blood vessel itself then and expands.In order effectively to improve the utilization rate of sacculus dilating catheter, save the operation cost, more people can therefrom be received benefits, interventional therapy operation in the blood vessel is promoted widely, a kind of foley's tube that carries out predilation and back expansion by different front and back end diameters arises at the historic moment.This foley's tube can well pass lesion locations and predilation by the tiny diameter of leading portion, and then by the blood vessel through predilation fully being expanded than major diameter of rear end, because the leading portion diameter is less, the sacculus leading portion can not produce damage to blood vessel.It should be noted that when selecting the sacculus size that the diameter that should consider lesion vessels itself is selected the outside diameter of sacculus, the damage that the big end of sacculus causes blood vessel when avoiding balloon expandable.Because the chronic pathological changes major part of entirely shutting is harder pathological changes, high pressure resistant sacculus can provide an enough intensity to open pathological changes, and under the sacculus effect of low compliance, balloon diameter growth under high pressure is relatively low, has also reduced the damage of blood vessel.The foley's tube of prior art is to the blood vessel of far-end bending, and in progradation, near-end thrust is passed to the transmission performance, handling bad of far-end.
Summary of the invention
The purpose of this utility model provides a kind of foley's tube, and the technical problem that solve is to improve foley's tube propelling movement property and passing through property, effectively expands lesion vessels, reduces the damage to blood vessel, improves the service efficiency of foley's tube.
This utility model is by the following technical solutions: a kind of foley's tube, be provided with sacculus, sacculus is connected with pressure chamber, described sacculus constitutes pressure chamber through far-end outer tube, near-end body to needle stand, the sacculus far-end is connected with catheter tip, the catheter tip external diameter is 0.40-1.14mm, and internal diameter is 0.26-0.95mm; Described far-end outer tube adopts nylon or nylon elastomer, and the near-end body adopts rustless steel or Ultimum Ti, or the near-end body adopts nylon, nylon elastomer, polyethylene or polyethers ether copper product; Be provided with interior pipe in the described pressure chamber, interior pipe far-end is connected with catheter tip, and interior pipe near-end is a guiding wire quick exchange mouth.
Catheter tip of the present utility model adopts three-layer co-extruded pipe, and internal layer is a high density polyethylene (HDPE), and the intermediate layer is for being the binding resin of base material with low density polyethylene (LDPE) or nylon material, and skin is nylon or nylon elastomer; Pipe adopts three-layer co-extruded pipe in described, and internal layer is a high density polyethylene (HDPE), and the intermediate layer is for being the binding resin of base material with low density polyethylene (LDPE) or nylon material, and skin is nylon or nylon elastomer; Pipe hardness was little in described catheter tip was compared, and both shore hardness D differences are: 0<D≤40.
The proximal, side wall of far-end outer tube of the present utility model has the hole, and the near-end of tapping and interior pipe is welded to connect, and forms the quick exchange mouth.
Needle stand of the present utility model is a breeches pipe, and remote stomidium is coaxial with one of near-end hole, and another axially bored line of one of near-end hole and near-end acutangulates; The near-end of pipe stretches out the near-end of near-end body in described, is communicated with another hole of near-end of needle stand, forms the quick exchange mouth.
Sacculus of the present utility model middle part is shaped as cylindric; Or it is columnar structured to be shaped as step in the middle part of the described sacculus, is connected and composed by 2-13 step, and the diameter of far-end cylinder adopts conical transition to connect less than the diameter of adjacent near-end cylinder between the cylinder; Or described sacculus middle part is shaped as near-end cylinder and far-end circular cone syndeton, and the close end diameter of far-end circular cone is identical with the near-end cylinder, and the nearer end diameter of distal portion diameter is little, and the cone angle of far-end circular cone is: 0<cone angle≤45 °; Or described sacculus middle part is shaped as taper shape, and the close end diameter of circular cone is greater than the distal portion diameter, and the cone angle of circular cone is: 0<cone angle≤45 °.
Sacculus of the present utility model two ends are connected with pin, and the external diameter of the external diameter of far-end pin and near-end pin is less than the external diameter at middle part, and far-end pin external diameter is less than near-end pin external diameter; The sacculus middle part is connected for the transition circle taper with the near-end pin with the far-end pin.
Catheter tip near-end of the present utility model puts in the far-end pin of sacculus, is connected with interior pipe in the far-end pin; Or described catheter tip puts in the far-end pin of sacculus and passes the far-end pin, is connected with interior pipe at the sacculus middle part; Or catheter tip put in the far-end pin of sacculus and pass the far-end pin, the sacculus middle part is to the near-end pin or pass the near-end pin, be connected with interior pipe in the near-end pin or in the far-end outer tube.
Be provided with body in the far-end outer tube of the present utility model and strengthen silk, the end that body strengthens silk is welded to connect at the distal end of near-end body or stretches out the close end of near-end body, and body strengthens the other end of silk to the near-end pin, and is linearly in free state.
Far-end outer tube of the present utility model is shaped as 2-4 level step round tube shape, and the distal portions diameter minimum that is connected with sacculus increases gradually to the proximal part diameter.
The junction of needle stand far-end of the present utility model and near-end body is outside equipped with the conduit reinforcement; Tube-surface is with the development Marking ring in described.
This utility model compared with prior art, catheter tip makes the far-end good toughness of foley's tube, good with the stickiness of guiding wire, handling on the such complex lesions of crooked lesion vessels and the chronic lesion vessels that entirely shuts, pass through lesion vessels ability height, sacculus smaller distal external diameter helps sacculus and passes through the terminal pathological changes of blood vessel, get through the lesion vessels position of obstruction, utilize the bigger external diameter of balloon proximal, lesion vessels is fully expanded, the blood vessel injury that causes is easily reduced, far-end outer tube propelling movement performance is good, reduce the cost of operation, meet a conduit using priciple.
Description of drawings
Fig. 1 is the foley's tube structural representation () of this utility model embodiment.
Fig. 2 is the A enlarged drawing of Fig. 1.
Fig. 3 is the B enlarged drawing of Fig. 1.
Fig. 4 is the C enlarged drawing of Fig. 1.
Fig. 5 is the foley's tube structural representation (two) of this utility model embodiment.
Fig. 6 is the D enlarged drawing of Fig. 5.
Fig. 7 is the E enlarged drawing of Fig. 5.
Fig. 8 is the F enlarged drawing of Fig. 5.
Fig. 9 is the pipe shaft structure chart () of the distal catheter of this utility model embodiment.
Figure 10 is the pipe shaft structure chart (two) of the distal catheter of this utility model embodiment.
Figure 11 is the balloon structure figure () of this utility model embodiment.
Figure 12 is the balloon structure figure (two) of this utility model embodiment.
Figure 13 is the balloon structure figure (three) of this utility model embodiment.
Figure 14 is catheter tip and the far-end inner tube structure figure () of this utility model embodiment.
Figure 15 is catheter tip and the interior pipe of the far-end enlarged drawing of Figure 14.
Figure 16 is catheter tip and the far-end inner tube structure figure (two) of this utility model embodiment.
Figure 17 is catheter tip and the interior pipe of the far-end enlarged drawing of Figure 16.
Figure 18 is catheter tip and the far-end inner tube structure figure (three) of this utility model embodiment.
Figure 19 is catheter tip and the interior pipe of the far-end enlarged drawing of Figure 18.
The specific embodiment
Below in conjunction with drawings and Examples this utility model is described in further detail.Foley's tube of the present utility model is provided with quick exchange foley's tube and two kinds of structures of whole exchange foley's tube.
As shown in Figure 1, described quick exchange foley's tube, from near-end to far-end, by the near-end body 4 of female cone female Luer needle stand (needle stand) 1, band lubricating layer 3, in be provided with far-end outer tube 6, sacculus 8 and the catheter tip 9 that body strengthens silk 5 and connect to form.Be provided with the surface in far-end outer tube 6 and the sacculus 8 and be with development Marking ring 13(such as Figure 11-shown in Figure 13) interior pipe 7.The axis of needle stand 1 endoporus is a straight line.
As shown in Figure 3, near-end body 4 is shaped as tubulose, adopts rustless steel or Ultimum Ti, and external diameter is 0.3-1.0mm, and internal diameter is 0.2-0.9mm.Outside the near-end of near-end body 4, middle part, far-end, be coated with cyclic lubricating layer 3, lubricating layer 3 adopts politef, nylon, nylon elastomer or polyethylene, thick 0.005-0.5mm, lubricating layer 3 are used for reducing the frictional force that process that near-end body 4 entered and withdrew from human vas produces.
As shown in Figure 4, the near-end of near-end body 4 and the lubricating layer of near-end 3 put in the endoporus of needle stand 1 far-end, and the near-end of near-end body 4 and needle stand 1 form by glue and be tightly connected.Junction at needle stand 1 far-end and near-end body 4 is outside equipped with conduit reinforcement 2, and conduit reinforcement 2 is put by interior reinforced pipe and outer reinforcement pipe box and constituted.Interior reinforced pipe is shaped as tubulose, and it is nested with outside the lubricating layer 3 of near-end body 4 near-ends, and the lubricating layer 3 of one section near-end with near-end body 4 of interior reinforced pipe near-end, near-end puts in the endoporus of needle stand 1 far-end.The distal portions of outer reinforced pipe is nested with one section of the far-end of interior reinforced pipe, and the proximal part enlarged-diameter of outer reinforced pipe is identical with needle stand 1 distal portions external diameter, and is nested with in the outside of needle stand 1 distal portions, forms to strengthen syndeton.
The far-end of near-end body 4 and the lubricating layer of far-end 3 put in the near-end of far-end outer tube 6, the near-end of far-end outer tube 6 from outside be nested with the far-end that is connected near-end body 4 and the lubricating layer 3 of far-end, by glue the far-end of near-end body 4 and far-end outer tube 6 are formed and are tightly connected.
Sacculus 8 middle parts are shaped as cylindric, two ends are connected with pin, wherein, the external diameter of the external diameter of far-end pin 14 and near-end pin 15 is less than the cylindric external diameter at middle part, be connected for the transition circle taper between barrel distal end and the far-end pin 14, for the transition circle taper is connected, far-end pin 14 external diameters are less than near-end pin 15 external diameters between cylinder near-end and the near-end pin 15.Far-end pin 14 external diameters are 0.41-1.38mm, and near-end pin 15 external diameters are 0.50-1.50mm.
Far-end outer tube 6, sacculus 8, catheter tip 9 are linked in sequence, and the far-end of far-end outer tube 6 is connected with the near-end pin 15 of sacculus 8, and the near-end of catheter tip 9 is connected with the far-end pin 14 of sacculus 8.
Far-end outer tube 6 adopts nylon or nylon elastomer, is shaped as 2-4 level step round tube shape, and the distal portions diameter minimum that is connected with sacculus 8 increases gradually to the proximal part diameter.Make to push near-end body 4 propelling movement power that produces and the moment of torsion that rotation needle stand 1 produces,, be passed to catheter tip 9 through near-end body 4, far-end outer tube 6 and sacculus 8.
As Fig. 2 and shown in Figure 9, the proximal, side wall of far-end outer tube 6 has the hole, and the near-end of tapping and interior pipe 7 is welded to connect, and forms the quick exchange mouth.To catheter tip 9, the far-end of interior pipe 7 is connected with catheter tip 9 interior pipe 7 in far-end outer tube 6, sacculus 8.
Interior pipe 7 adopts three-layer co-extruded pipe, and internal layer is slick high density polyethylene (HDPE), and the intermediate layer is for being the binding resin of base material with low density polyethylene (LDPE) or nylon material, and skin is nylon or nylon elastomer material, and external diameter is 0.40-1.14mm, and internal diameter is 0.26-0.95mm.
Catheter tip 9 adopts three-layer co-extruded pipe, internal layer is slick high density polyethylene (HDPE), and the intermediate layer is for being the binding resin of base material with low density polyethylene (LDPE) or nylon material, and skin is nylon or nylon elastomer material, external diameter is 0.40-1.14mm, and internal diameter is 0.26-0.95mm.Catheter tip 9 and interior pipe 7 are connected by butt welding, form the body of soft or hard material transition.Pipe 7 hardness were little in catheter tip 9 was compared, and both shore hardness D differences are: 0<D≤40, can be better and the guiding wire applying, and pass through crooked pathological changes with guiding wire easily.
Interior pipe 7 forms guiding wire tract 11 with the inner chamber that catheter tip 9 constitutes, and the activity space of guiding wire is provided.
The inner chamber that is communicated with by needle stand 1, near-end body 4, far-end outer tube 6 and sacculus 8 forms pressure chamber 12, and pressure chamber 12 can be delivered to the pressure that outside pressurising device provides sacculus 8 inside that are positioned at far-end and make sacculus 8 expansions.
As Figure 11-shown in Figure 13, development Marking ring 13 is circular, and the material platinumiridio that employing can be developed under X-ray, gold or tungsten gold are nested with on the interior pipe 7 that is set in place in sacculus 8, quantity is 2-14, is used for operation process is indicated sacculus 8 under X-ray position.
Be provided with body in the far-end outer tube 6 and strengthen silk 5, an end of body enhancing silk 5 is welded to connect the distal end at near-end body 4, and body strengthens the other end of silk 5 to the near-end pin 15 near sacculus 8, and is linearly in free state.Body strengthens silk 5 and adopts rustless steel or Ultimum Ti, external diameter is 0.10-0.75mm, be used to strengthen the bulk strength of distal catheter 6 pipe shafts, and to the junction of near-end body 4 and far-end outer tube 6 since the sudden change of the intensity of both intensity generation inequality play a transition role.
As shown in Figure 5, described whole exchange foley's tube, from near-end to far-end, by female cone female Luer needle stand (needle stand) 1, conduit reinforcement 2, band withdraw from Marking ring 10 near-end body 4, in be provided with far-end outer tube 6, sacculus 8 and the catheter tip 9 that body strengthens silk 5 and connect to form.Be provided with the surface in needle stand 1, near-end body 4, far-end outer tube 6 and the sacculus 8 and be with development Marking ring 13(such as Figure 11-shown in Figure 13) interior pipe 7.Needle stand 1 is a breeches pipe, and remote stomidium is coaxial with one of near-end hole, and another axially bored line of one of near-end hole and near-end acutangulates.
As shown in Figure 7, near-end body 4 is shaped as tubulose, adopts nylon, nylon elastomer, polyethylene or polyethers ether copper product, and external diameter is 0.3-2.0mm, and internal diameter is 0.2-1.8mm.Near-end at near-end body 4 is equipped with the cyclic Marking ring 10 that withdraws from.Withdraw from Marking ring 10 and adopt nylon, nylon elastomer or polythene material.Pipe 7 is arranged in the near-end body 4 in piped, is provided with body and strengthens silk 5 between interior pipe 7 and near-end body 4.
As shown in Figure 8, the near-end that near-end body 4, the interior pipe 7 in it and body strengthen silk 5 puts in the endoporus of needle stand 1 far-end, the near-end of near-end body 4 and needle stand 1 form and are tightly connected, the proximal end that the near-end of interior pipe 7 and body enhancing silk 5 stretches out near-end body 4, the proximal orifice of interior pipe 7 is communicated with another hole of near-end of needle stand 1.Junction at needle stand 1 far-end and near-end body 4 is outside equipped with conduit reinforcement 2, and conduit reinforcement 2 is nested with in the outside of near-end body 4 with the junction of needle stand 1, forms and strengthens syndeton.Conduit reinforcement 2 is shaped as cylindric, and its endoporus has two cannelures, and the annular protrusion that is used for during assembling on the needle stand 1 far-end excircle snaps in wherein, and far-end one end is taper.
As shown in Figure 6, the far-end of near-end body 4 puts in the near-end of far-end outer tube 6, the near-end of far-end outer tube 6 from outside be nested with the far-end that is connected near-end body 4, the far-end of near-end body 4 and far-end outer tube 6 forms and is tightly connected.
Far-end outer tube 6, sacculus 8, catheter tip 9 are linked in sequence, and the far-end of far-end outer tube 6 is connected with the near-end pin 15 of sacculus 8, and the near-end of catheter tip 9 is connected with the far-end pin 14 of sacculus 8.
As shown in figure 10, interior pipe 7 is arranged in the far-end outer tube 6.To catheter tip 9, the far-end of interior pipe 7 is connected with catheter tip 9 interior pipe 7 in far-end outer tube 6, sacculus 8.Another hole of the near-end of needle stand 1 is the quick exchange mouth, and the near-end of interior pipe 7 is communicated with another hole of near-end of needle stand 1.The space that another hole of the near-end of needle stand 1, interior pipe 7 and catheter tip 9 are communicated with forms guiding wire tract 11, and the activity space of guiding wire is provided.
Be provided with body in the far-end outer tube 6 and strengthen silk 5, an end of body enhancing silk 5 stretches out the close end of near-end body 4, and body strengthens the other end of silk 5 to the near-end pin 15 near sacculus 8, and free state linearly.
The inner chamber that is communicated with by one of the near-end of needle stand 1 hole and remote stomidium, near-end body 4, far-end outer tube 6 and sacculus 8 forms pressure chamber 12, and pressure chamber 12 can be delivered to the pressure that outside pressurising device provides sacculus 8 inside that are positioned at far-end expands sacculus 8.
Sacculus 8 middle part shapes except that above-mentioned cylindric, can also be variable-diameter structure, increase progressively from distal-to-proximal with the diameter of section of sacculus 8 axis normal.
As shown in figure 11, it is columnar structured that sacculus 8 middle parts are shaped as step, connected and composed by two cylindrical section far-end cylinders and near-end cylinder, and the diameter of far-end cylinder is less than the diameter of near-end cylinder, adopts conical transition to be connected between far-end cylinder and the near-end cylinder.For the transition circle taper is connected, be connected for the transition circle taper between near-end cylinder and the near-end pin 15 between far-end cylinder and the far-end pin 14.Terraced structure can be a 2-13 step, and the difference of the diameter of adjacent step is 0.25-4mm.
As shown in figure 12, sacculus 8 middle parts are shaped as near-end cylinder and far-end circular cone syndeton, and the close end diameter of far-end circular cone is identical with the near-end cylinder, and the nearer end diameter of distal portion diameter is little, and the cone angle of far-end circular cone is: 0<cone angle≤45 °.For the transition circle taper is connected, be connected for the transition circle taper between near-end cylinder and the near-end pin 15 between far-end circular cone and the far-end pin 14.
As shown in figure 13, sacculus 8 middle parts are shaped as taper shape, and the close end diameter of circular cone is greater than the distal portion diameter, and the cone angle of circular cone is: 0<cone angle≤45 °.For the transition circle taper is connected, be connected for the transition circle taper between circular cone near-end and the near-end pin 15 between tapered distal and the far-end pin 14.
As Figure 14 and shown in Figure 15, catheter tip 9 is shaped as tubulose.Its near-end puts in the far-end pin 14 of sacculus 8, is tightly connected with interior pipe 7 in far-end pin 14.
As Figure 16 and shown in Figure 17, piped catheter tip 9 puts in the far-end pin 14 of sacculus 8 and passes far-end pin 14, arbitrary position and interior pipe 7 at sacculus 8 middle parts are welded to connect, and are positioned on the far-end, catheter tip 9 at sacculus 8 middle parts to be equipped with development Marking ring 13.
As Figure 18 and shown in Figure 19, piped catheter tip 9 put in the far-end pin 14 of sacculus 8 and pass far-end pin 14, sacculus 8 middle parts are to near-end pin 15 or pass near-end pin 15, near-end pin 15 or far-end outer tube 6 in and interior pipe 7 be welded to connect.
Foley's tube of the present utility model can adopt following method to make and obtain, and is made up of the acquisition and the installation step of each parts, may further comprise the steps:
One, the acquisition of each parts:
1, the injection moulding needle stand 1, particles with polyurethane or makrolon material, adopt the Boy30M model injection machine of German Boy limited company, under warm 200-250 ℃ in material, mold temperature 50-80 ℃, injection pressure 20-70bar, injection speed 30-70% and the condition of 20-50 second cool time,, obtain meeting the needle stand 1 with 6% Rule tapering connector of ISO594 standard by the molding of injection mold.
2, adopt the standard heat-shrinkable T bush of the 2:1 shrinkage ratio of U.S. ZEUS limited company, model: AWG15 or AWG16; Material: politef, as conduit reinforcement 2.
3, the internal diameter of the German Heraeus of employing group is the near-end body 4 of the band lubricating layer 3 of 0.2-0.9mm.
4, the rustless steel or the Ultimum Ti of the German Heraeus of employing group, external diameter is the 0.10-0.75mm silk, strengthens silk 5 as body.
5, make far-end outer tube 6, with nylon or nylon elastomer particles, adopt the DS10HM model extruder of U.S. Davis-Standard responsibility company limited, extrusion condition by 40-90 of barrel temperature 400-500 ℃, die temperature 400-500 ℃, 400-500 ℃ of Melt Pump temperature, pressure 50-80bar, hauling speed 20-50m/min, tank temperature, extrusion molding, obtaining internal diameter is 0.45-1.78mm, and external diameter is the far-end outer tube 6 of 0.60-2.10mm.
6, adopting the internal diameter of U.S. ZEUS limited company is the three-layer co-extruded pipe of 0.26-0.95mm, as interior pipe 7.
7, make sacculus 8, adopt the tubing of nylon, nylon elastomer and more than one material co-extrusions of polyethylene terephthalate, by the cylindrical shape sacculus mould, on the sacculus make-up machine, temperature is 90-180 ℃ a high temperature, pressure is to be blow molded into the middle part under the atmospheric highly compressed condition of 10-50 to be shaped as cylindricly, and far-end pin 14 external diameters are less than near-end pin 15 external diameters.Reducing sacculus to different size can be realized by corresponding sacculus mould.It is that 0.25-1.0mm, external diameter are that 0.38-1.65mm material pipe and internal diameter are the 0.5-5.0mm sacculus mould that the material pipe of sacculus and sacculus mould can adopt the internal diameter of American I nterface company, and the sacculus make-up machine can adopt the BF208 type sacculus make-up machine of German Han Cishade responsibility company limited Heinz Schade GmbH.
8, adopting the internal diameter of U.S. ZEUS limited company is the three-layer co-extruded pipe of 0.26-0.95mm, as catheter tip 9.
9, adopt nylon, nylon elastomer or the polythene material pipe of U.S. ZEUS limited company, internal diameter is 0.4-2.1mm, and external diameter is 0.55-2.25mm, is cut into the ring that length is 5-10mm, as withdrawing from Marking ring 10.
10, adopt the metal tube of platinumiridio, gold or the tungsten gold of U.S. Johnson Matthey medical components company, internal diameter is 0.45-0.65mm, and external diameter is 0.5-0.75mm, and the cutting back is as development Marking ring 13.
Two, assembling
(1), assembling quick exchange foley's tube:
1, presses the far-end pin 14 of sacculus 8 and the length that near-end pin 15 two ends keep 2-5mm, adopt common single or double blade to cut unnecessary pin.
2, with common single or double blade, far-end outer tube 6 is cut the length to 25-50cm, and at distance distal end 15-35cm place, cut out the osculum of long 2.5mm, be used to form the quick exchange mouth with the knife-edge of band sharp-crested.
3, the far-end with far-end outer tube 6 inserts in the near-end pin 15 of sacculus 8; overlapping with near-end pin 15; overcoat welding protection cover welds both by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) then on the near-end pin 15 of sacculus 8.If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
4, both dock with catheter tip 9 and interior pipe 7, and overcoat welding protection cover gets up both butt joints by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding).If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
5, development Marking ring 13 is nested with on interior pipe 7, by the forging and pressing machine development Marking ring 13 is fixedly secured on interior pipe 7, the position of development Marking ring 13 is arranged on the correspondence position in the sacculus 8.If adopt the ROMA3 swaged forging press device of German Han Cishade responsibility company limited Heinz Schade GmbH, the pressing mold internal diameter is 0.48-0.73mm.
6, the far-end with catheter tip 9 and interior pipe 7 puts in from the osculum that far-end outer tube 6 cuts, from sacculus 8 far-end pins 14, pass, by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) far-end of interior pipe 7 and the osculum of far-end outer tube 6 are welded to connect, form the quick exchange mouth.If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
7, by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) sacculus 8 far-end pins 14 and catheter tip 9 are welded together, finish the distal component assembling of sacculus 8 and catheter tip 9.If adopt German Han Cishade responsibility company limited Heinz Schade GmbH's) WSH1 type hot gas welding meets sb. at the airport, and welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
8, body is strengthened 5mm in the far distance port that silk 5 puts in near-end body 4, both weld together by laser-beam welding machine then.If the SWMP model laser-beam welding machine of the German Rofin of employing company, energy output is 15-35mJ, and protective gas is an argon, and vacuum is 0.05mPa.
9, the near-end with near-end body 4 puts in needle stand 1, carry out adhering and sealing by UV glue, and conduit reinforcement 2 is nested with outside near-end body 4 and needle stand 1, with the junction of conduit reinforcement 2 pyrocondensations, forms a transition connection by hot-air blower to needle stand 1 and near-end body 4.The UV point gum machine can adopt the EFD900-15 type UV point gum machine of U.S. promise letter EFD company, and each gel quantity is set to 0.1-0.5ml and gets final product; Hot-air blower can adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, and welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
10, the near-end of far-end outer tube 6 is nested with the far-end of near-end body 4, make far-end outer tube 6 and near-end body 4 overlapping 30mm, the far-end that body strengthens silk 5 puts in the far-end outer tube 6, to close sacculus 8 near-end pins 15, by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) far-end outer tube 6 and near-end body 4 are welded together then, obtain the quick exchange foley's tube.Bonding machine can adopt German Han Cishade responsibility company limited Heinz Schade GmbH's) WSH1 type hot gas welding meets sb. at the airport, and welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
(2), the whole exchange of assembling foley's tube:
1, presses the far-end pin 14 of sacculus 8 and the length that near-end pin 15 two ends keep 2-5mm, adopt common single or double blade to cut unnecessary pin.
2, with common single or double blade, far-end outer tube 6 is cut to 25-50cm.
3, the far-end with far-end outer tube 6 inserts in the near-end pin 15 of sacculus 8; overlapping with near-end pin 15; overcoat welding protection cover welds both by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) then on the near-end pin 15 of sacculus 8.If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
4, both dock with catheter tip 9 and interior pipe 7, and overcoat welding protection cover gets up both butt joints by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding).If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
5, development Marking ring 13 is nested with on interior pipe 7, by the forging and pressing machine development Marking ring 13 is fixedly secured on interior pipe 7, the position of development Marking ring 13 is arranged on the correspondence position in the sacculus 8.If adopt the ROMA3 swaged forging press device of German Han Cishade responsibility company limited Heinz Schade GmbH, the pressing mold internal diameter is 0.48-0.73mm.
6, will withdraw from Marking ring 10 and be nested with on the near-end body 4, will withdraw from Marking ring 10 by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) and be welded on the near-end body 4.If adopt the hot gas welding of the WSH1 model of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
7, the near-end of far-end outer tube 6 is nested with the far-end of near-end body 4, makes far-end outer tube 6 and near-end body 4 overlapping 5mm, both are welded together by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding).If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
8, with interior pipe 7 through near-end body 4, far-end body 6 and sacculus 8, pass from the far-end pin 14 of sacculus 8, by bonding machine (hot gas welding, Laser Welding, infrared ray weldering or supersonic welding) its far-end and far-end pin 14 and catheter tip 9 are welded together.If adopt the WSH1 type hot gas welding of German Han Cishade responsibility company limited Heinz Schade GmbH to meet sb. at the airport, welding temperature is 200-270 ℃, and be 5-20 second weld interval, and air pressure is 20-50psig.
9, adopt common single or double blade, will expose interior pipe 7 excisions in near-end body 4 outsides, interior pipe 7 length of guaranteeing to expose outside near-end body 4 near-ends are 5-50mm.
10, body is strengthened silk 5 and penetrate from near-end body 4, the far-end that makes body strengthen silk is positioned at the nearly far-end of far-end body 6, by UV glue both is adhered to each other at near-end, and gluing length is about 5mm.The UV point gum machine can adopt the EFD900-15 type UV point gum machine of U.S. promise letter EFD company, and each gel quantity is set to 0.1-0.5ml and gets final product.
11, the near-end of near-end body 4 far distance port from needle stand 1 is stretched into, then by needle stand 1 surface design some Jiao Kou inject UV glue and interior pipe 7 and body are strengthened silk 5 carry out adhering and sealing with near-end body and needle stand 1.The UV point gum machine can adopt the EFD900-15 type UV point gum machine of U.S. promise letter EFD company, and each gel quantity is set to 0.1-0.5ml and gets final product.
12, be nested with conduit reinforcement 2 on the distal portions draw-in groove outward of needle stand 1 by the hot-air blower pyrocondensation, forming a transition connects, obtain whole exchange foley's tube, hot-air blower can adopt the hot gas welding of German Han Cishade responsibility company limited (Heinz Schade GmbH) WSH1 model to meet sb. at the airport, welding temperature is 200-270 ℃, be 5-20 second weld interval, and air pressure is 20-50psig.
During operation, guiding wire is introduced into the vascular lesion position, and the near-end of guiding wire penetrates from the far-end of foley's tube, passes from the quick exchange mouth through guiding wire tract 11, and foley's tube can enter into the vascular lesion position along guiding wire.In the process that pushes foley's tube, body strengthens silk 5 and can help the propelling movement power of balloon catheter proximal end is delivered to sacculus 8 until catheter tip 9, behind the position by development Marking ring 13 definite sacculus 8, outside pressurising device is connected with needle stand, by pressure chamber 12 external pressure is passed to sacculus 8 sacculus 8 is strutted, the expansion lesion vessels.The expansion back release pressure that finishes is withdrawn from guiding wire after withdrawing from foley's tube.Use second foley's tube further to expand or during implant frame if desired, only need withdraw from foley's tube, keep guiding wire in vivo, change the foley's tube or the mounting system that need and continue lesion locations is further expanded or implant frame, withdraw from guiding wire and foley's tube after operation finishes.For the quick exchange foley's tube, use the guiding wire of full-length (180-195 centimetre), single getting final product simply be finished the operation of expanding lesion vessels fast, but can not change seal wire.For integral body exchange foley's tube, use the guiding wire of lengthening (300 centimetres), operation technique needs the assistant to assist to finish, compare the quick exchange foley's tube, because guiding wire and the coaxial distribution of guiding wire tract, whole exchange foley's tube to the control of guiding wire better and can be changed the required various guiding wires of operation very easily.The foley's tube of reducing can at utmost reduce the usage quantity of foley's tube, operation technique process simplification.
This utility model adopts far-end outer tube 6, sacculus 8 and the softer catheter tip 9 of reducing.Catheter tip 9 makes the far-end good toughness of foley's tube, and is good with the stickiness of guiding wire, handling on the such complex lesions of crooked lesion vessels and the chronic lesion vessels that entirely shuts, passes through lesion vessels ability height.Sacculus 8 becomes big by far-end gradually to near-end, the smaller distal external diameter helps sacculus 8 and passes through the terminal pathological changes of blood vessel, get through the lesion vessels position of obstruction, utilize the bigger external diameter of sacculus 8 near-ends, lesion vessels is fully expanded, simultaneously can also be to expanding more fully through pretreated lesion vessels.Sacculus 8, is reduced the blood vessel injury that causes easily when near-end becomes big structure gradually and also makes the balloon expandable lesion vessels by far-end.Far-end outer tube 6 makes that the propelling movement performance is good, structure of the present utility model is incorporated into guiding wire tract 11 and pressure chamber 12 together, use a ball ductus bursae to implement operation as much as possible, avoid a plurality of foley's tubes to handle the situation of same place lesion vessels, effectively improve the utilization rate of single foley's tube, simplify doctor's operation sequence, reduced the cost of operation, met a conduit using priciple.

Claims (10)

1. foley's tube, be provided with sacculus (8), sacculus (8) is connected with pressure chamber (12), it is characterized in that: described sacculus (8) constitutes pressure chamber (12) through far-end outer tube (6), near-end body (4) to needle stand (1), sacculus (8) far-end is connected with catheter tip (9), catheter tip (9) external diameter is 0.40-1.14mm, and internal diameter is 0.26-0.95mm; Described far-end outer tube (6) adopts nylon or nylon elastomer, and near-end body (4) adopts rustless steel or Ultimum Ti, or near-end body (4) adopts nylon, nylon elastomer, polyethylene or polyethers ether copper product; Be provided with interior pipe (7) in the described pressure chamber (12), interior pipe (7) far-end is connected with catheter tip (9), and interior pipe (7) near-end is a guiding wire quick exchange mouth.
2. foley's tube according to claim 1, it is characterized in that: described catheter tip (9) adopts three-layer co-extruded pipe, internal layer is a high density polyethylene (HDPE), and the intermediate layer is for being the binding resin of base material with low density polyethylene (LDPE) or nylon material, and skin is nylon or nylon elastomer; Pipe (7) adopts three-layer co-extruded pipe in described, and internal layer is a high density polyethylene (HDPE), and the intermediate layer is for being the binding resin of base material with low density polyethylene (LDPE) or nylon material, and skin is nylon or nylon elastomer; It is little that described catheter tip (9) is compared interior pipe (7) hardness, and both shore hardness D differences are: 0<D≤40.
3. foley's tube according to claim 1 is characterized in that: the proximal, side wall of described far-end outer tube (6) has the hole, and the near-end of tapping and interior pipe (7) is welded to connect, and forms the quick exchange mouth.
4. foley's tube according to claim 1 is characterized in that: described needle stand (1) is a breeches pipe, and remote stomidium is coaxial with one of near-end hole, and another axially bored line of one of near-end hole and near-end acutangulates; The near-end of pipe (7) stretches out the near-end of near-end body (4) in described, is communicated with another hole of near-end of needle stand (1), forms the quick exchange mouth.
5. foley's tube according to claim 1 is characterized in that: described sacculus (8) middle part is shaped as cylindric; Or it is columnar structured to be shaped as step in the middle part of the described sacculus (8), is connected and composed by 2-13 step, and the diameter of far-end cylinder adopts conical transition to connect less than the diameter of adjacent near-end cylinder between the cylinder; Or described sacculus (8) middle part is shaped as near-end cylinder and far-end circular cone syndeton, and the close end diameter of far-end circular cone is identical with the near-end cylinder, and the nearer end diameter of distal portion diameter is little, and the cone angle of far-end circular cone is: 0<cone angle≤45 °; Or described sacculus (8) middle part is shaped as taper shape, and the close end diameter of circular cone is greater than the distal portion diameter, and the cone angle of circular cone is: 0<cone angle≤45 °.
6. foley's tube according to claim 5, it is characterized in that: described sacculus (8) two ends are connected with pin, the external diameter of the external diameter of far-end pin (14) and near-end pin (15) is less than the external diameter at middle part, and far-end pin (14) external diameter is less than near-end pin (15) external diameter; Sacculus (8) middle part is connected for the transition circle taper with near-end pin (15) with far-end pin (14).
7. foley's tube according to claim 6 is characterized in that: described catheter tip (9) near-end puts in the far-end pin (14) of sacculus (8), is connected with interior pipe (7) in far-end pin (14); Or described catheter tip (9) puts in the far-end pin (14) of sacculus (8) and passes far-end pin (14), is connected with interior pipe (7) at sacculus (8) middle part; Or catheter tip (9) put in the far-end pin (14) of sacculus (8) and pass far-end pin (14), sacculus (8) middle part is to near-end pin (15) or pass near-end pin (15), be connected with interior pipe (7) in near-end pin (15) or in the far-end outer tube (6).
8. foley's tube according to claim 6, it is characterized in that: be provided with body in the described far-end outer tube (6) and strengthen silk (5), one end of body enhancing silk (5) is welded to connect at the distal end of near-end body (4) or stretches out the close end of near-end body (4), body strengthens the other end of silk (5) to near-end pin (15), and is linearly in free state.
9. foley's tube according to claim 1 is characterized in that: described far-end outer tube (6) is shaped as 2-4 level step round tube shape, and the distal portions diameter minimum that is connected with sacculus (8) increases gradually to the proximal part diameter.
10. foley's tube according to claim 1 is characterized in that: the junction of described needle stand (1) far-end and near-end body (4) is outside equipped with conduit reinforcement (2); Pipe (7) surface is with development Marking ring (13) in described.
CN 201320042948 2013-01-25 2013-01-25 Balloon catheter Expired - Fee Related CN203090196U (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105435357A (en) * 2015-12-04 2016-03-30 浙江归创医疗器械有限公司 PTA balloon dilatation catheter
CN106214140A (en) * 2016-10-17 2016-12-14 苏州亘科医疗科技有限公司 Ink vessel transfusing blood pressure measurement seal wire
CN106730273A (en) * 2016-12-20 2017-05-31 深圳脉动医学技术有限公司 A kind of repairing type foley's tube and preparation method thereof
CN109310283A (en) * 2016-04-19 2019-02-05 波士顿科学国际有限公司 Foley's tube visualization device including reinforcing element
CN109908453A (en) * 2019-03-15 2019-06-21 兰州大学第一医院 A kind of auxiliary guiding catheter passes through the device of tortuous blood vessel
CN110193132A (en) * 2019-05-17 2019-09-03 业聚医疗器械(深圳)有限公司 A kind of foley's tube
CN110248692A (en) * 2016-12-16 2019-09-17 巴德股份有限公司 Foley's tube and its method
CN110475578A (en) * 2017-02-23 2019-11-19 圣犹达医疗用品心脏病学部门有限公司 For conveying the flexible torque cable of medical device
WO2022100402A1 (en) * 2020-11-13 2022-05-19 微创神通医疗科技(上海)有限公司 Catheter and choke catheter

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105435357A (en) * 2015-12-04 2016-03-30 浙江归创医疗器械有限公司 PTA balloon dilatation catheter
CN109310283A (en) * 2016-04-19 2019-02-05 波士顿科学国际有限公司 Foley's tube visualization device including reinforcing element
CN106214140A (en) * 2016-10-17 2016-12-14 苏州亘科医疗科技有限公司 Ink vessel transfusing blood pressure measurement seal wire
CN110248692A (en) * 2016-12-16 2019-09-17 巴德股份有限公司 Foley's tube and its method
CN106730273A (en) * 2016-12-20 2017-05-31 深圳脉动医学技术有限公司 A kind of repairing type foley's tube and preparation method thereof
CN110475578A (en) * 2017-02-23 2019-11-19 圣犹达医疗用品心脏病学部门有限公司 For conveying the flexible torque cable of medical device
CN109908453A (en) * 2019-03-15 2019-06-21 兰州大学第一医院 A kind of auxiliary guiding catheter passes through the device of tortuous blood vessel
CN109908453B (en) * 2019-03-15 2022-05-31 兰州大学第一医院 Device for assisting in guiding catheter to pass through tortuous blood vessel
CN110193132A (en) * 2019-05-17 2019-09-03 业聚医疗器械(深圳)有限公司 A kind of foley's tube
WO2022100402A1 (en) * 2020-11-13 2022-05-19 微创神通医疗科技(上海)有限公司 Catheter and choke catheter

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