CN2780227Y

CN2780227Y - Medical operation filar guide instrument

Info

Publication number: CN2780227Y
Application number: CN 200420056994
Authority: CN
Inventors: 杨大智; 吴卫
Original assignee: DALIAN HEALTH ISLAND TECHNOLOGY Co Ltd
Current assignee: DALIAN HEALTH ISLAND TECHNOLOGY Co Ltd
Priority date: 2004-11-15
Filing date: 2004-11-15
Publication date: 2006-05-17
Anticipated expiration: 2014-11-15

Abstract

The utility model relates to a medical intervention operation wire guiding instrument which is mainly composed of an axial wire 20, a solenoid 30 of a wire guiding head and an ultra-slide coating layer 40, wherein the axial wire 20 of a guiding wire is made of a nickel-titanium alloy wire, the axial wire 20 of the guiding wire is uniform thinned from the near end to the far end in sections. The solenoid 30 of the wire guiding head is packaged on the axial wire 20 at the far end. The solenoid 30 is composed of different solenoids 31, 33, wherein the near end of the solenoid 31 is welded the near end of a second kind of diameter section 23 of the axial wire 20, the far end of the solenoid 31 and the near end of the solenoid 33 are alternatively wound together and welded on a second uniformly changing diameter section 24 of the axial wire 20, and the far end of the solenoid 33 and the head end of a section 25 of the axial wire 20 of the guiding wire are welded together. A first kind of diameter section 21 of the axial wire 20 of the guiding wire is coated by the ultra-slide coating layer 40. The medical intervention operation wire guiding instrument has favorable anti-kinking performance and lubricating performance. The head end is soft and has favorable formability and visibility.

Description

A kind of medical intervene operation seal wire apparatus

Technical field

This utility model relates to a kind of interventional medical device, more precisely, is a kind of medical intervene operation seal wire apparatus, for example in percutaneous coronary artery angiography intracavity forming operation (PTCA) as the guide instrument of foley's tube, belong to medical instruments field.

Background technology

Percutaneous coronary artery angiography intracavity forming operation (PTCA) is a kind of effective medical procedure for the treatment of the coronary stricture disease, nowadays can replace coronary bypass surgery to a great extent.In the operation process, the conduit (foley's tube) that front end has sacculus passes patient's cardiovascular system, is imported the coronary artery of patient's heart by the doctor.Then inflation is pushed and is torn the atherosclerotic plaque that is deposited in the arteria coronaria and causes coronary stricture, thereby reaches dredging vascellum, recovers the purpose of channel of blood flow.For preventing the blood vessel access restenosis, can also then carry out Stent, a metal rack is strutted in lesion by sacculus, play supporting role to blood vessel.In above-mentioned operation process, an indispensable key technology is exactly the utilization of seal wire.At first insert seal wire in the guide catheter and guide catheter enters patient's cardiovascular system together.After guide catheter put in place, seal wire stretched out from the far-end of guide catheter, entered patient's arteria coronaria blood vessel, passed the lesion that will be expanded until the far-end of seal wire.Foley's tube can enter the patient's coronary artery blood vessel along the path that seal wire forms subsequently, and finally places the coronary stenosis place accurately.In whole process, seal wire all should be high-visible under corresponding x-ray image equipment, so that the clear and definite seal wire of doctor is in the intravital concrete orientation of patient.Whether successful can see that seal wire has been set up one and reach the passage of far-end from the site of puncture to the diseased region or by diseased region, be decision PTCA operation key factor.

Medical intervene operation seal wire in the past adopts a thick stainless steel silk as the axle center silk, and the front end that thinner stainless steel silk is welded on thick steel wire is as formed strip, and the front end of seal wire twines thinner stainless steel silk as the protection structure.This design can provide support force preferably to conduit, but the compliance of front end is often bad, causes the damage of blood vessel easily.Particularly in the blood vessel access of complicated bend, this design is easy to owing to over-drastic bending causes the kink of seal wire head end, and this is breakneck in operation.Simultaneously because thick stainless steel silk and thin stainless steel silk are structurally discontinuous, the moment of torsion that when doctor undergos surgery the seal wire rear end is applied has loss in being delivered to the process of front end.And the design that has is made with having the superelastic nickel titanium alloy merely, can make the shape after seal wire keeps machine-shaping, bring very burden but for the operation preforming that preceding doctor takes the seal wire head end according to pathological changes, and this design is visual bad.

When seal wire is mobile in blood vessel, will rub with blood vessel.Seal wire should alleviate the friction when internal blood vessel is moved as far as possible, and the resistance of propelling movement seal wire and seal wire are to the damage of blood vessel when performing the operation to reduce.

In sum, current seal wire has following new specification requirement: stainless steel silk requires to improve antitorque knot performance as the seal wire of axle center silk.The requirement of the front end of Nitinol seal wire has formability and visuality.Seal wire should be able to reduce at endovascular frictional resistance as far as possible.In addition, the solenoid of seal wire head end is wanted firm being fixed on the silk of axle center, in order to avoid " hang down and take off " phenomenon takes place in operation process.The purpose of this utility model and task provide a kind of rational solution to specification requirement set forth above exactly.

Summary of the invention

This utility model relates to a kind of medical intervene operation seal wire apparatus, mainly comprises: seal wire axle center silk 20, conductive filament head solenoid 30 and superslide coating 40; It is characterized in that: seal wire axle center silk 20 is made by nitinol alloy wire, and axle center silk 20 evenly attenuates from near-end to distal portion section; Conductive filament head solenoid 30 is wrapped on the far-end axle center silk 20, constitute by two kinds of

different solenoids

31,33, wherein solenoid 31 is by the stainless steel filament coiled, solenoid 32 is by platinum alloy or tungsten alloy filament coiled, the near-end of solenoid 31 is welded on the near-end of second kind of diameter section 23 of axle center silk 20, the near-end of the far-end of solenoid 31 and solenoid 33 alternately is intertwined, and be welded on the axle center silk even variation diameter section 20 second time 24, the head end of the flat filament 25 of the far-end of solenoid 33 and seal wire axle center silk 20 welds together; Superslide coating 40 is coated on the major part of first diameter section 21 of seal wire axle center silk 20, to guarantee its greasy property.

Of the present utility model being further characterized in that: make seal wire axle center silk 20 selected nitinol alloy wires and under the temperature of room temperature and body temperature, can present super-elasticity; In order to make the head end softness of seal wire, the distal portion section of axle center silk 20 evenly attenuates, axle center silk 20 is D1 at the diameter of section 21, until first section 22 that evenly attenuates, next the diameter of axle center silk section 23 is D2, and until second section 24 that evenly attenuates, diameter becomes 0.07mm afterwards, this section silk is processed into flat filament 25, with the flexibility of further raising seal wire head end; Conductive filament head solenoid 30 is made of jointly stainless steel silk solenoid 31 and platinum alloy silk or tungsten alloy filament solenoid 33; Solenoid 31 plays the effect of supporting axle center silk 20 and protection blood vessel, its near-end is welded on the near-end of second kind of diameter section 23 of axle center silk 20 by solder joint 32, solenoid 31 is compact winding, and along axle center silk 20 to the seal wire remote extension, the axle center silk be tapered for the second time the part proximal part separate with axle center silk 20; The flat filament 25 of the far-end of solenoid 33 and axle center silk 20 far-ends links together by solder joint 34, and form the hemispherical of an antisitic defect, because platinum alloy and tungsten alloy have good roentgenopaque ability and malleability, solenoid 33 has good visual performance and forming property, solenoid 33 along axle center silk 20 to the seal wire proximal extension, in order further to increase the flexibility of seal wire head end, solenoid 33 is when twining between the adjacent filament gapped 36; The near-end of the far-end of solenoid 31 and solenoid 33 alternately is intertwined and connected and is in the same place, and is fixed on the axle center silk even variation diameter section 20 second time 24 by solder joint 35; The section 21 of seal wire axle center silk 20 applies superslide coating 40 to guarantee its greasy property, and this superslide coating can be polytetrafluorethylecoatings coatings or hydrophilic coating.

Advantage of the present utility model:

1) the axle center silk adopts the nitinol alloy wire of handling through super-elasticity, can demonstrate good anti-knot performance in the tortuous crooked blood vessel of patient;

2) structural design of axle center silk is that the distal portion section evenly attenuates, and head end is the structure of flat filament, has guaranteed the softness of wire distal, and the structure of " rhizoid " can be delivered to wire distal to the doctor to the moment of torsion that the seal wire near-end applies to greatest extent simultaneously;

3) adopt the solenoid that platinum alloy or tungsten alloy twine to guarantee that wire distal has good visuality and formability, this solenoidal loose winding arrangement has further strengthened the flexibility and the formability of seal wire head end simultaneously;

4) two kinds of solenoidal connected modes and three fixedly solder joint can guarantee firm being fixed on the silk of axle center of conductive filament head solenoid, the generation of the phenomenon that prevents from " to hang down and take off " in the operation;

5) the superslide coating that constitutes of politef or hydrophilic coating, in the time of can effectively reducing seal wire and in blood vessel, move to the friction of blood vessel.

Description of drawings

Embodiment according to seal wire apparatus of the present utility model is illustrated among Fig. 1, and the profile of cutting open along the A-A line according to the embodiment of seal wire apparatus of the present utility model is illustrated among Fig. 2.

The specific embodiment

By following example detailed description with the accompanying drawing, feature and advantage of the present utility model will clearly be expressed.Wherein:

Fig. 1 blocks for the part of a kind of medical intervene operation seal wire apparatus example that designs according to principle of the present utility model, the side view that part is broken away;

The profile that Fig. 2 cuts open along the A-A line for above-mentioned example.

Fig. 1 blocks for the part of a kind of medical intervene operation seal wire apparatus example 10 that designs according to principle of the present utility model, the side view that part is broken away.The length of whole seal wire 10 is about 175 centimetres.The axle center silk 20 of seal wire 10 is made by the Nitinol solid body, and cross section is circular.Nitinol has super-elasticity under room temperature and body temperature, for seal wire provides good support performance and antitorque knot performance.

The initial diameter D1 of axle center silk 20 near-ends is about 0.25 to 0.45 millimeter, and preferred diameter is 0.33 millimeter.The initial diameter D1 of axle center silk 20 remains unchanged on its section 21, and the length of section 21 is about 145 centimetres.When axle center silk 20 entered section 22, diameter began evenly to diminish, and is taper.After the about 5 centimetres variation of process, diameter becomes D2, is about 0.19 millimeter.Section 23 keeps diameter D2 constant, and length is approximately 17 centimetres.Axle center silk 20 begins again evenly to diminish at section 24 diameters, and the variation through about 7 centimetres becomes 0.07 millimeter.Ensuing axle center silk 20 is flat filaments that are about 1 centimeter length 25 of being made by the silk of 0.07 millimeter of diameter, and wide is 0.03 millimeter, and its cross section as shown in Figure 2.More than design has guaranteed that axle center silk 20 runs through seal wire all the time, helps the near-end moment of torsion and better is delivered to wire distal.

Conductive filament head solenoid 30 is made of jointly two kinds of solenoids 31,33.Solenoid 31 is formed by medical stainless steel silk compact winding, and gauge of wire is about 0.06 millimeter.Solenoid 31 is wrapped on the axle center silk 20, links together by pad 32 at the near-end and the axle center silk 20 of section 23.Solenoid 31, separates with axle center silk 20 at section 24 to the seal wire remote extension along axle center silk 20.The effect of solenoid 31 is to protect blood vessel injury-free simultaneously for softish axle center silk 20 provides certain support force.Solenoid 33 is entwined by platinum alloy filament or tungsten alloy filament, and the diameter of filament is about 0.06 millimeter.In order to make head end soft more, solenoid 33 is gapped 36 between the adjacent filament when twining, and is about 0.02 millimeter.Solenoid 33 can make under the X-ray of far-end solenoid 30 ends in operation process high-visible, is convenient to the doctor and judges the position of seal wire in human body.Solenoid 33 has good malleability simultaneously, is convenient to the doctor and according to pathological changes the seal wire head end is carried out preforming before art.The far-end of solenoid 33 and flat filament 25 link together by pad 34.The head of pad 34 forms a slick hemispherical, to prevent the damage to got involved blood vessel.Solenoid 33 is towards the proximal extension of seal wire, and its near-end and solenoid 31 far-ends alternately twine, and by pad 35 two solenoidal connecting portions is fixed on the axle center silk 20.Two kinds of solenoidal outer diameter D 3 are basic identical with the diameter D1 of axle center silk 20, and remain unchanged.

The section 21 of seal wire axle center silk 20 applies superslide coating 40 to guarantee its greasy property, and this superslide coating can be polytetrafluorethylecoatings coatings or hydrophilic coating, and thickness is about 5 to 10 microns.

Size and the design of describing example above being appreciated that only are used for showing the application of this utility model principle.Under the condition that does not depart from principle of the present utility model and protection domain, those skilled in the art can carry out various changes to above-mentioned size and design.The claims of present specification will cover the size and the design of these changes.

Claims

1. medical intervene operation seal wire apparatus, mainly by seal wire axle center silk [20], conductive filament head solenoid [30] and superslide coating [40] three parts constitute, and it is characterized in that:

(a) seal wire axle center silk [20] is made by the nitinol alloy wire through the super-elasticity treatment process, and axle center silk [20] evenly attenuated from near-end to the distal portion stage;

(b) conductive filament head solenoid [30] is wrapped on the far-end axle center silk [20], is made of two kinds of different solenoids [31], [33];

(c) superslide coating [40] is coated on the major part in the first diameter stage [21] of seal wire axle center silk [20], to guarantee its greasy property.

2. by the described a kind of medical intervene operation seal wire apparatus of claim 1, it is characterized in that axle center silk [20] is made by nitinol alloy wire, the composition of Nitinol is that nickle atom compares between 50%～51%, has super-elasticity under room temperature and the body temperature.

3. by claim 1 or 2 described a kind of medical intervene operation seal wire apparatuses, it is characterized in that, the initial diameter [D1] of axle center silk [20] is 0.33 to 0.35 millimeter in stage [21] excursion, in the ensuing stage [22], it is conical that axle center silk [20] is, until becoming second kind of diameter [D2], excursion is 0.25 to 0.20 millimeter, stage [23] keeps diameter [D2] constant, stage [24] is conical afterwards, become 0.07 millimeter up to axle center silk [20] diameter, become the flat stage [25] again.

4. by the described a kind of medical intervene operation seal wire apparatus of claim 1, it is characterized in that first kind of solenoid [31] made by stainless steel filament, second kind of solenoid [33] made by platinum alloy or tungsten alloy filament.

5. by claim 1 or 4 described a kind of medical intervene operation seal wire apparatuses, it is characterized in that the head end in the flat stage [25] of solenoid [33] far-end and seal wire axle center silk [20] links together, and form guidewire tip [35].

6. by claim 1 or 3 described a kind of medical intervene operation seal wire apparatuses, it is characterized in that between the adjacent filaments gapped [36], size is 0.02 millimeter to solenoid [33] when twining.

7. by claim 1 or 3 described a kind of medical intervene operation seal wire apparatuses, it is characterized in that overall diameter [D3] excursion of first kind of solenoid [31] and second kind of solenoid [33] is 0.33 to 0.35 millimeter.

8. by the described a kind of medical intervene operation seal wire apparatus of claim 1, it is characterized in that the superslide coating of coating is politef or hydrophilic coating.