CN209575486U - Intermediate conductor - Google Patents
Intermediate conductor Download PDFInfo
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- CN209575486U CN209575486U CN201821644536.7U CN201821644536U CN209575486U CN 209575486 U CN209575486 U CN 209575486U CN 201821644536 U CN201821644536 U CN 201821644536U CN 209575486 U CN209575486 U CN 209575486U
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Abstract
The utility model provides a kind of intermediate conductor, including by proximal end to the seat, stress release pipe and conduit distally set gradually；It mainly thes improvement is that conduit is along axial direction by closely proximal end push section, middle-end supporting section, distally section is controlled in torsion and super distal end tracks section to being far distributed with；Catheter tip and super distal end tracking section are coaxially connected；The duct of seat and the coaxial of conduit connect into lead-in cavity；Liner layer, intermediate strengthening layer and surrounding layer, the intermediate strengthening layer are radially distributed with from the inside to the outside and is connected respectively with liner layer and surrounding layer for conduit.The utility model is capable of providing the excellent pushability of proximal segment, the good vessel support in middle section, the torsion control property of distal section high torque response and the tortuous blood vessel passability of complexity of super distal section, convenient for tube passing therethrough encephalic distal vessels or conveys other instruments to more distal vessels.
Description
Technical field
The utility model relates to a kind of intermediate conductors, and in particular to one kind is diagnosed or treated brain blood by ganglioside GM_3 method
The intermediate conductor of lesion, belongs to the field of medical instrument technology in managing.
Background technique
Cerebral apoplexy is commonly called as " apoplexy " or " cerebrovascular accident ", is a kind of acute cerebrovascular diseases, is due to cranial nerve blood vessel
Suddenly rupture or angiemphraxis cause blood can not normal supply brain and cause brain tissue impairment class disease, including ischemic and
Hemorrhagic apoplexy.The disease incidence of Ischemic Stroke accounts for the 60%~70% of cerebral apoplexy sum.The most common reason that cerebral apoplexy occurs
It is to have small embolus on brain blood supply blood vessel, arterial embolism, i.e. Ischemic Stroke is caused after falling off.Coronary heart disease is with atrial fibrillation
Patient, heart valve are easy to happen lateral thrombus, and embolus can block the cerebrovascular after falling off, may also lead to Ischemic Stroke.
Other factors have hypertension, diabetes, hyperlipidemia etc..Investigation display, cerebral apoplexy is to be with the neurologic impairment of acute attack
The syndrome of feature reflects the confusion of central nervous system, is the result of disturbance of cerebral circulation, it has also become China's adult's death and
Disabled first cause has the characteristics that disease incidence is high, the death rate is high and disability rate is high.Wherein arteria cerebri media be cerebral apoplexy most
The position often occurred, branch are easily broken bleeding, and the outer embolus of cranium is easiest to enter middle cerebral artery M 1 segment and its branch, and leads
Cause the cerebral infarction or cerebral embolism in the region.
Intermediate conductor after entering the arch of aorta from femoral artery puncture, then is moved into neck based on interventional minimally-invasive treatment principle
Arteries and veins even Cerebral Arterial Circles extend for diagnosing, the novel distal end passability conduit of delivery instrument or treatment.In the prior art,
Treatment of Cerebral Stroke operation more common method has intravenous thrombolysis and cranial nerve blood vessel machinery to take two kinds of bolt, the appearance of intermediate conductor,
Internal carotid lesion for the occlusion of diagnosing and treating intracranial vessel acute and chronic or the medium above tortuous degree provides new thinking.
Similar product currently on the market has the Envoy DA conduit of Johson & Johnson, using end-to-end metal knitted knot
Structure increases the length of distal end of catheter softness section, it is ensured that can be pushed to rock section in neck to cavernous segment.Sofia DAC/Plus
Using the structure of inner core of spring plus braiding epitheca, the tip provided with particularly soft improves the ability by tortuous blood vessel.But
Most of intermediate conductor is because of the limitation of self structure, and proximal end push power is insufficient, and distal end torque responsive is insufficient, leads to distal end of catheter
The cervical part of esophagus or rock section that can only be transported in neck can not pass through cavernous segment in neck and reach farther position, as cerebral apoplexy is high-incidence
Middle cerebral artery M 1 segment, this limitation also relative effect purposes of intermediate conductor.
Summary of the invention
The purpose of the utility model is to overcome the deficiencies in the prior art, provide a kind of intermediate conductor, Neng Gouti
For the pushability that proximal segment is excellent, middle section good vessel support, the torsion control property of distal section high torque response and super distal section are answered
Miscellaneous tortuous blood vessel passability convenient for tube passing therethrough encephalic distal vessels or conveys other instruments to more distal vessels.This is practical new
Type the technical solution adopted is that:
A kind of intermediate conductor, including by proximal end to the seat, stress release pipe and conduit distally set gradually；It is mainly improved
Place is,
Conduit is along axial direction by closely to being far distributed with, proximal end push section, middle-end supporting section, distal end turns round control section and super distal end tracks
Section；Catheter tip and super distal end tracking section are coaxially connected；The duct of seat and the coaxial of conduit connect into lead-in cavity；
Liner layer, intermediate strengthening layer and surrounding layer, the intermediate strengthening layer difference is radially distributed in conduit from the inside to the outside
It is connected with liner layer and surrounding layer.
Further, the material of liner layer is PTFE, and elongation is 5%~80%.Further, the extension of liner layer
Rate is 40%~50%, and thickness range is 0.005~0.03mm.
Further, the intermediate strengthening layer of proximal end push section is using reinforcing mesh grid；The reinforcing mesh grid includes oblique
Braided wires and axial reinforced wire are knitted to form.
Further, the reinforcing mesh grid increases axial add on the basis of the mesh grid that the oblique braided wires of 2x2 are weaved into
Strong silk constitutes the reinforcing mesh grid of three-dimensional structure；Axial reinforced wire is axially laid along conduit, in two oblique braided wires infalls
It is passed through among two oblique braided wires；Strengthen the pitch d1 of mesh grid along axial direction by closely to being far gradually incremented by；
The pitch d1 for strengthening mesh grid is 0.05mm~0.7mm, and strengthens the pitch d1 of mesh grid along axial direction by closely extremely
Far 0.7mm is gradually incremented to from 0.05mm.
Further, strengthen mesh grid oblique braided wires and conduit radial direction formed by angle α 2 be 30 °~
65°。
Further, the intermediate strengthening layer of middle-end supporting section is arranged elastic network(s) using spiral winding, alternatively, middle-end supporting section
Intermediate strengthening layer include strengthen from proximally push section mesh grid extend the axial reinforced wire that comes and spiral winding constitute it is strong
Change spiral winding, alternatively, being arranged the elastic network(s) in the reinforcing spiral winding.
Further, elastic mesh is distributed on elastic network(s), the shape of elastic mesh is ellipse, interior in ellipse
Embedding cruciform shape or diamond structure embed the long and short axis of shape respectively with elliptical long and short overlapping of axles, and long axis direction edge is led
The axial direction of pipe is uniformly distributed, and short-axis direction is uniformly distributed along the circumferencial direction of conduit.
Further, elastic mesh is 0.15~0.9mm along the pitch d2 range of conduit axial direction, and elastic mesh is along conduit
Circumferential width range is 0.1~0.3mm, and the wall thickness range of elastic network(s) is 0.01~0.1mm.
The pitch range of middle-end supporting section spiral winding is 0.1mm~0.7mm, axial by close along conduit in middle-end supporting section
To remote decreasing pitch；It is consistent that the control spiral winding of section is turned round with distal end.
Further, control section is turned round in distal end and the strengthening layer of super distal end tracking section uses spiral winding, alternatively, control section is turned round in distal end
(303) and the strengthening layer (308) of super distal end tracking section (304) includes that the spiral winding and proximal support section (301) reinforcing are compiled
Knitmesh extends the reinforcing spiral winding that the axial reinforced wire to come is constituted；The gap filling of spiral winding has strong flexible polymer,
The internal layer and/or outer layer of spiral winding are coated with the strong flexible polymer coating for having compatibility with the strong flexible polymer.
Further, strong flexible polymer uses copoly type thermoplastic elastomer (TPE) or mechanical blending type thermoplastic elastic
Body；Wherein, it is 30D~55D that the strong flexible polymer shore hardness of control section is turned round in distal end；Super distal end tracks the strong flexible polymer of section
Shore hardness is 40A~85A；
Strong flexible polymer coating material is copoly type thermoplastic elastomer (TPE)；
When the strong flexible polymer coating is applied only to the spiral winding outer layer, thickness range is 0.01~0.1mm；
When being applied only to spiral winding internal layer, thickness range is 0.001~0.02mm；When internal layer and outer layer coated in spiral winding,
Range of coat thicknesses coated in outer layer be 0.001~0.03mm, the range of coat thicknesses coated in internal layer be 0.001~
0.01mm；
The pitch range that control section spiral line circle is turned round in distal end is 0.1mm~0.7mm, and it is axial by close along conduit to turn round control section in distal end
To remote decreasing pitch；
The pitch range of super distal end tracking section spiral line circle is 0.01mm~0.5mm, super distal end tracking section along axial direction by
Closely to remote decreasing pitch.
Further, surrounding layer is blended using copoly type thermoplastic elastomer (TPE) and lubricating additive；
The elastomer of surrounding layer includes the PEBAX that control section is turned round in proximal end push section, middle-end supporting section and distal end, and super distal end
Track the polyurethane of section；
The PEBAX hardness that proximal end pushes section is 63D~74D；The PEBAX hardness of middle-end supporting section is 55D~63D；Distally
The PEBAX hardness for turning round control section is 40D~55D；The polyurethane hardness of super distal end tracking section is 60A~85A；
The hardness of the proximal end of surrounding layer to distal end is successively decreased in multisection type；
The thickness range of surrounding layer is 0.01~0.2mm.
Further, catheter tip uses the polyurethane material of line style flexible macromolecule modification by copolymerization；The shape of catheter tip
Shape is that straight cone or length are curved.
Further, the distal end for surpassing distal end tracking section is provided with developing ring or surpasses the proximally and distally each of distal end tracking section
It is provided with developing ring.
Developing ring is equipped with rectangle using hollow out ring structure or the developing ring outside of axially aligned regular rectangular shape hole
Dentalation.
Further, the PTFE material of liner layer is fast to 270 DEG C~320 DEG C of temperature, then with constant cooling through heated at constant temperature
After 10 DEG C~20 DEG C/min of rate are made annealing treatment, apply normal speed 10mm~80mm/ minutes and specified stress 5N~40N
It is axially stretched, the elongation after stretching is controlled 5%~80%.
Compared with prior art, the utility model has the advantage that
1, liner layer described in the utility model through heated at constant temperature to the fusing point close to polytetrafluoroethylene (PTFE) (PTFE), with constant drop
After warm rate is made annealing treatment, applies normal speed and stress is axially stretched, so that the C-C of Crystalline plastics PTFE
Chain is orientated along axial height, can reduce liner layer entirety crystallinity, enhancing liner layer is in axial tensile strength and axial distribution
The uniformity；By the control of elongation, reduce the thickness of liner, increase the internal diameter of lead-in cavity, promotes instrument in lead-in cavity
Axially through property.
2, reinforcing mesh grid described in the utility model increases axial reinforced wire on the basis of 2 × 2 oblique braided wires, constitutes
The reinforcing mesh grid of three-dimensional structure has fettered the interaction and migration of oblique braided wires to a certain extent, has improved mesh grid
Radial rigidity and axial tensile strength so that conduit has excellent radial support performance and axial direction in proximal end push section
Performance is pushed, pipe shaft can be protected to bear biggish pressure, proximal end is preferably transmitted and pushes power；By the optimum angle for selecting braid angle
Degree realizes the optimization of mesh grid radial rigidity and axial tensile-strength.
3, elastic network(s) described in the utility model is by metal pipe material using the net for being laser-cut into porous, multiple-limb, thin-walled
Shape structure can adjust the radial support and elasticity of elastic network(s) according to the selection of material and the design of mesh form；Elastic network(s)
Using the design of the structure of oval embedded right-angled intersection or irregular diamond shape: the long and short axis of embedded shape respectively with it is elliptical long and short
Overlapping of axles, long axis direction are uniformly distributed along the axial direction of conduit, and short-axis direction is uniformly distributed along the circumferencial direction of conduit, and with ellipse
Junction through round corner treatment.The design of this class formation ensures that elastic network(s) can well adapt to the nature of blood vessel in long axis direction
Bending, and enough supportives can be provided to conduit in short-axis direction, prevent pipe shaft from collapsing or bending.When elastic network(s) is set in spiral shell
On spin line circle or when being arranged through on the reinforcing spiral winding axially reinforced, be conducive to provide well for the middle-end supporting section of conduit
Axial compliance and radial support, preferably to adapt to the life of big blood vessel (such as complex-shaped, the changeable arch of aorta)
Reason bending, is bonded blood vessel, reduces the complication such as vasopasm.
4, the gap filling of spiral winding described in the utility model has blending or copoly type thermoplastic elastomer (TPE), resilient coil
Internal layer and/or outer layer be coated with copoly type thermoplastic elastomer (TPE) coating.By the material, the pitch, filling that change spiral winding
The material of polymer, the strong flexible polymer coating for increasing internal layer or outer layer and change the thickness of coating to improve distal end of catheter
It turns round control section and super distal end tracks the flexibility and high resiliency of section, realize that the excellent kink resistance of control section is turned round in distal end and super distal end tracks
The flexibility of Duan Youyi.The strong flexible polymer or liner layer of strong flexible polymer coating and filling have in the selection of material
Good compatibility, prevents from occurring migrating between coating and filler or liner layer or slip layer.Such design ensures soft surpass
Distal end tracking section, which is easier to pass through the complicated tortuous blood vessel in encephalic distal end, (can especially pass through that C3 siphon in neck is curved and C4 cavernous segment
Reach the high-incidence middle cerebral artery M 1 segment of cerebral arterial thrombosis), and (such as microtubular takes bolt to other instruments for assisting in lead-in cavity
Instrument etc.) reach more distal vessels.Control section is turned round in the distal end of antitorque knot can provide good torque responsive, prevent conduit complicated circuitous
It is bent in bent blood vessel.
5, axial reinforced wire described in the utility model can push that section extend to middle-end supporting section, control section is turned round in distal end by proximal end or
It one section or several sections in super distal end tracking these pipe shaft sections of section, is constituted with the spiral winding and strengthens spiral winding.The structure
Advantage is the deformation for significantly limiting spiral winding in axial tension or compression process, while not influencing this section of pipe shaft entirety
Torsion control, flexibility or high resiliency, i.e., reduction conduit is when passing through the complicated tortuous blood vessel in encephalic distal end because of spiral winding part
Pipe shaft by proximal end push section lasting propulsion/withdraw the bending force etc. one that power, the resistance of tortuous blood vessel, conduit comply with blood vessel
Serial active force and the pipe shaft axial direction excess compression/tensile deformation generated, prevent conduit cavity internal diameter from changing, it is ensured that conduit
Good desired use.
6, developing ring described in the utility model using axially aligned regular rectangular shape hole, thin-walled engraved structure or
Rectangular toothed structure, when being set in the spiral winding of super distal end tracking section distal end or proximal end or strengthening spiral winding, compared to uniform
The developing ring of cylindrical structure can comply with the variation of spiral winding axial/radial, and the entirety for neither influencing super distal end tracking section is soft
It is soft, it also ensures that the position that entire super distal end tracking section 304 can be accurately positioned under X-ray in intracranial vessel, realizes
Super distal end tracking section 304 passes through visualized operation when complicated tortuous blood vessel.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of the intermediate conductor of the utility model.
Fig. 2 is each segment length schematic diagram of intermediate conductor of the utility model.
Fig. 3 a and Fig. 3 b are that the utility model proximal end pushes section, middle-end supporting section, distal end torsion control section and super distal end tracking section
Structural schematic diagram, show middle-end supporting section elasticity two kinds of structures of mesh respectively.
Fig. 3 c is that the utility model axial direction reinforced wire extends to middle-end supporting section, control section is turned round in distal end or super distal end tracking section
Structural schematic diagram.
Fig. 4 is the D-D diagrammatic cross-section of Fig. 3 a of the utility model, Fig. 3 b.
Fig. 5 a, Fig. 5 b, Fig. 5 c, Fig. 5 d are respectively four kinds of schematic cross-sections that the utility model strengthens mesh grid.
Fig. 6 is the C-C diagrammatic cross-section of Fig. 3 a of the utility model, Fig. 3 b.
Fig. 7 a, Fig. 7 b, A-A, B-B diagrammatic cross-section that Fig. 7 c is Fig. 3 a of the utility model, Fig. 3 b, show high-elastic respectively
Three kinds of embodiments of property polymer coating.
Fig. 8 a, Fig. 8 b, Fig. 8 c are the strengthening layer that control section is turned round in the distal end filled with strong flexible polymer and super distal end tracks section
Three kinds of schematic cross-sections.
Fig. 9 a and Fig. 9 b are respectively two kinds of structural schematic diagrams of developing ring.
Specific embodiment
Below with reference to specific drawings and examples, the utility model is described in further detail.
As shown in Figure 1, intermediate conductor provided by the utility model, including by proximal end to seat 1, the stress distally set gradually
Discharge pipe 2 and conduit 3.
Conduit 3 is along axis to by closely to being far distributed with, proximal end push section 301, middle-end supporting section 302, distally section 303 is controlled in torsion
Section 304 is tracked with super distal end；Wherein surpass distal end tracking section 304 is proximally and distally each provided with developing ring 305, catheter tip 4
It is coaxially connected with super distal end tracking section 304；The duct of seat 1 and the coaxial of conduit 3 connect into lead-in cavity 1301.
As shown in Fig. 2, the length L6 of the proximal end push section 301 is 50-100cm, the length L5 of middle-end support end 302 is
20-50cm, the length L4 that control section 303 is turned round in distal end is 5-18cm, and the length L3 for surpassing distal end tracking section 304 is 1-8cm；L1 is centre
Conduit total length (120-160cm), L2 are the effective length of intermediate conductor；L2=L3+L4+L5+L6.The inside diameter ranges of conduit 3
For 1.1-1.8mm, external diametrical extent 1.3-2.2mm.
As shown in figure 4, liner layer 309, intermediate strengthening layer 308 and surrounding layer is radially distributed in conduit 3 from the inside to the outside
306；The intermediate strengthening layer 308 is connected with liner layer 309 and surrounding layer 306 respectively.
The material of the liner layer 309 is polytetrafluoroethylene (PTFE) (PTFE), is to have the crystal type of preferable greasy property poly-
Close object；The material of liner layer 309 through heated at constant temperature to 270 DEG C~320 DEG C of temperature, close to 327 DEG C of fusing point of PTFE, then with constant
After 10 DEG C~20 DEG C/min of rate of temperature fall are made annealing treatment, apply normal speed 10mm~80mm/ minutes and specified stress 5
~40N is axially stretched, and the elongation control after stretching reduces the whole crystallinity and thickness of PTFE liner 5%~80%
Degree；Elongation 40%~50% is preferred optimum range；By the liner PTFE for annealing and being axially stretched, it is intended to pass through reduction
The crystallinity of overall material improves the axial orientation of C-C strand in PTFE, reaches the tensile strength for increasing liner axial direction and divides
The purpose of the cloth uniformity.By the control of elongation, reduce the thickness of liner layer, reaches in the lead-in cavity for increasing intermediate conductor
Diameter promotes the purpose axially through property of instrument.
As shown in Fig. 3 a, 3b, Fig. 4, proximal end pushes the intermediate strengthening layer 308 of section 301 using reinforcing mesh grid 3011；It is described
Strengthen mesh grid on the basis of the mesh grid that the oblique braided wires of 2x2 are weaved into, increases axial reinforced wire；Constitute the reinforcing of three-dimensional structure
Mesh grid；As shown in Fig. 5 a, 5b, 5c, 5d, axial reinforced wire 3011a is along the axial laying of conduit 3, in two oblique braided wires
3011b, 3011c infall pass through among two oblique braided wires；The material for strengthening mesh grid 3011 is 304 stainless steels, nickel
Titanium alloy or copper.The reinforcing mesh grid 3011 of the three-dimensional structure is conducive to improve the radial direction of intermediate conductor proximal end push section 301
Rigidity and axial tensile-strength, so that conduit has excellent radial support performance and axial push performance in proximal end push section.
Be conducive to intermediate conductor and preferably transmit proximal end push power, provides push for super distal end tracking section arrival more distal vessels and support.
Strengthening angle α 2 formed by the oblique braided wires and conduit radial direction of mesh grid 3011 is 30 °~80 °, angle α 2
It is preferred best angle for 30 °~65 °.Strengthen mesh grid 3011 pitch d1 (distance of adjacent oblique braided wires axial direction) be
0.05~0.7mm, and strengthen the pitch d1 of mesh grid 3011 along axial direction by closely to being far gradually incremented to 0.7mm from 0.05mm.
By selecting the best angle of braid angle α 2, the optimization of mesh grid radial rigidity and axial tensile-strength is realized.
Oblique braided wires 3011b, 3011c, axial reinforced wire 3011a diameter be 0.05mm~0.15mm.
Respectively as shown in Fig. 5 a, 5b, 5c, 5d, the section of oblique braided wires 3011b, 3011c, axial reinforced wire 3011a
Shape can be semicircle, trapezoidal, rectangle, circle, can also be regular hexagon.
As shown in Fig. 3 a, 3b, 3c, Fig. 6, the intermediate strengthening layer 308 of middle-end supporting section 302 turns round control section 303 using with distal end
Consistent spiral winding 3031 is arranged elastic network(s) 3021a, 3021b, alternatively, the intermediate strengthening layer 308 of middle-end supporting section 302 includes
The axial reinforced wire that proximally push section 301 strengthens that mesh grid extension comes is constituted with spiral winding strengthens spiral winding, in institute
It states reinforcing spiral winding and is arranged the elastic network(s).
Elastic network(s) 3021a, 3021b are porous, the multiple-limb, thin-walled that metal pipe material is used to laser one excision forming
The elastic network(s) of structure；Be distributed with elastic mesh on elastic network(s), elastic mesh along the pitch d2 range of conduit axial direction be 0.15~
0.9mm, elastic mesh are 0.1~0.3mm along the width range of conduit circumferential direction；The wall thickness range of elastic network(s) is 0.01~0.2mm.
The material of elastic network(s) is 304 stainless steels or Nitinol；The difference of elastic network(s) 3021a, 3021b are that elastic mesh embeds shape
Difference.
The shape of the elasticity mesh is ellipse, and cruciform shape or diamond structure are embedded in ellipse；Cross is handed over
Fork-shaped or diamond shape and elliptical junction are through round corner treatment.
The long and short axis of embedded shape respectively with elliptical long and short overlapping of axles, long axis direction along conduit it is axial uniformly point
Cloth, short-axis direction are uniformly distributed along the circumferencial direction of conduit.The design of this class formation ensures that conduit middle-end locating for elastic network(s) supports
Duan Jineng can provide enough supportives to conduit in radial direction in the physiological bending for axially well adapting to big blood vessel, preferably
Fitting blood vessel, prevent pipe shaft from collapsing or bending by major blood vessel flexion sites (such as intravascular arch of aorta position), have
Good axial compliance and radial support are provided conducive to for the middle-end supporting section of conduit.
The pitch range of 302 spiral winding of middle-end supporting section is 0.1mm~0.7mm, in middle-end supporting section along conduit axial direction
By closely to remote decreasing pitch；The spiral winding 3031 for turning round control section 303 with distal end is consistent.
As shown in Fig. 3 a, 3b, Fig. 7 a, 7b, 7c, control section 303 is turned round in distal end and the strengthening layer 308 of super distal end tracking section 304 is adopted
With spiral winding 3031,3041；Spiral winding 3031,3041 is entwined by the wire of S type helical structure, the wire
Diameter or thickness range be 0.05~0.3mm；Spiral winding and conduit radial direction angle α 1 are 30 °~80 °.
The pitch range that control 303 spiral winding 3031 of section is turned round in distal end is 0.1mm~0.7mm, turns round control section 303 along leading in distal end
Pipe is axial by closely to remote decreasing pitch.
The pitch range of super distal end tracking 304 spiral winding 3041 of section is 0.01mm~0.5mm, in super distal end tracking section
304 along axial direction by closely to remote decreasing pitch.
Alternatively, as shown in Figure 3c, control section 303 and the strengthening layer 308 of super distal end tracking section 304 are turned round using reinforcing braiding in distal end
Net extends the axial reinforced wire to come and spiral winding 3031,3041 respectively constitutes and strengthens spiral winding 3032,3042.Its axis
To reinforced wire may extend to middle-end supporting section 302, control section 303 is turned round in distal end or super distal end tracking section 304 in one section of pipe shaft or
Multistage pipe shaft.
As shown in Fig. 8 a, 8b, 8c, the gap filling of spiral winding has strong flexible polymer 308a；Strong flexible polymer
308a material is polyurethanes (TPU), polystyrene type (S-TPE), polyesters (TPEE), polyolefins (TPO), organic fluoride class
(TPF), the copoly types thermoplastic elastomer (TPE)s such as polysiloxane-based (SiO-TPE), polyamide (TPAE) class, or by ethylene propylene diene rubber
(EDPM) with polypropylene (PP) blending and modifying, nitrile rubber (NBR) and PP blending and modifying mechanical blending type thermoplastic elastomer (TPE).
It is preferred that the scope control of shore hardness is in 40A~85A or 30D~55D when polyurethane elastomer is as packing material.Wherein
The polyurethane shore hardness that control section 303 is turned round in distal end is preferably 30D~55D, and the polyurethane shore hardness for surpassing distal end tracking section is preferred
For 40A~85A.
As shown in Fig. 7 a, 7b, 7c, the internal layer and/or outer layer of spiral winding are coated with strong flexible polymer coating 307, high
307 material of elastomeric polymer coating is copoly type thermoplastic elastomer (TPE), and the strong flexible polymer 308a of the coating and filling has
Good compatibility.
By change strong flexible polymer coating 307 thickness (range 0.001-0.05mm), realize distal end turn round control section and
Super distal end tracks the flexibility and high resiliency of section.The strong flexible polymer coating 307 is applied only to the spiral winding 3031
When with 3041 outer layer, preferred thickness range is 0.01~0.1mm；It is excellent when being applied only to spiral winding 3031 and 3041 internal layer
The thickness range of choosing is 0.001~0.02mm；When internal layer and outer layer coated in spiral winding 3031 and 3041, it is coated in outer layer
Coating layer thickness preferred scope be 0.001~0.03mm, the coating layer thickness preferred scope coated in internal layer be 0.001~
0.01mm。
High resiliency by the material of change spiral winding, pitch, the material of filled polymer, increase internal layer or outer layer is poly-
The thickness for closing object coating and change coating turns round control section and the super flexibility and high resiliency for distally tracking section to improve distal end of catheter,
Realize that the excellent kink resistance of the control section flexibility excellent with super distal end tracking section is turned round in distal end.This class formation ensures that intermediate conductor is soft
Soft super distal end tracking section is easier to pass through the complicated tortuous blood vessel in encephalic distal end, and assists other instruments in lead-in cavity (such as micro- to lead
Manage, take bolt instrument, guiding catheter etc.) reach more distal vessels.Control section is turned round in the distal end of antitorque knot can provide good torque responsive,
Prevent conduit from bending in complicated tortuous blood vessel.
The surrounding layer 306 is blended using copoly type thermoplastic elastomer (TPE) and lubricating additive, passes through double screw extruder
Extrusion obtains the surrounding layer with certain lubricant effect；Lubricating additive is hard using hydrophilic macromolecule additive, polyethylene glycol
Resin acid esters material or self-lubricating high molecular material.The elastomer of the surrounding layer preferably France A Kema or Germany, which win, creates solid moral
The block polyetheramides elastomer (PEBAX) of match, shore hardness scope control is in 30~80D；It is preferred that polyurethane, shore hardness model
System is contained in 50~90A.The elastomer of surrounding layer includes the PEBAX that control section is turned round in proximal end push section, middle-end supporting section and distal end, with
And super distal end tracks the polyurethane of section；Wherein the PEBAX hardness of proximal end push section is 63D~74D；The PEBAX of middle-end supporting section
Hardness is 55D~63D；The PEBAX hardness that control section is turned round in distal end is 40D~55D；The polyurethane hardness of super distal end tracking section is 60A
~85A；The hardness of the proximal end of surrounding layer 306 to distal end is successively decreased in 4~40 sections of multisection type.The thickness range of surrounding layer is 0.01
~0.2mm.
As shown in Fig. 1,9a, 9b, the developing ring 305 is formed using the methods of laser cutting, machining along axial row
It is equipped with rectangular toothed structure 3052 outside the regular rectangular shape hole of column, the hollow out ring structure 3051 of thin-walled or developing ring, is arranged
In the spiral winding of super distal end tracking section distal end or proximal end or when strengthening spiral winding, compared to the developing ring of uniform cylindrical structure,
The variation of spiral winding axial/radial can be complied with, the whole flexibility that super distal end tracks section is neither influenced, also ensures that and penetrated in X
Position of the entire super distal end tracking section 304 in intracranial vessel can be accurately positioned under the conditions of line, realize that super distal end tracking section 304 is logical
Cross visualized operation when complicated tortuous blood vessel.
Catheter tip 4 uses the polyurethane material of line style flexible macromolecule modification by copolymerization, in the molecular structure base of polyurethane
The branch of Long carbon chain is introduced on plinth, such structure is conducive to increase the flexibility and pliability of material.Its shore hardness is in warm, power
Flexible specific angle under the influence of, especially available steam carry out moulding to catheter tip, preset certain bending angle
Degree is conducive to catheter tip and passes through complicated tortuous blood vessel.The shape of the catheter tip is that straight cone or length are curved.
In a specific embodiment, it is the intermediate conductor of acquisition " the big wall of chamber is thin ", when making liner layer 309, leads to
Selected annealing rate and stress rate of extension are crossed, so that the elongation of the liner layer preferably 50%, controls the thickness of liner layer 309
Degree range is 0.005~0.03mm.Between on the make when strengthening layer 308, middle-end supporting section 302, distal end turn round control section 303 and super remote
The material preferred nickel/titanium alloy of the spiral winding 3031 and 3041 of end tracking section 304, preferably 45 ° and 60 ° respectively of radial angle α 1,
Pitch difference preferably 0.25~0.4mm and 0.08~0.2mm；Control section 303 is turned round in distal end and the high resiliency of super distal end tracking section 304 is poly-
The shore hardness for closing object 308a distinguishes the polyurethane of preferred 35D and 80A, and the strong flexible polymer coating 307 is coated in described
The internal layer of spiral winding 3031 and 3041, material are preferably organo-fluorine polymer elastomer (TPF), and thickness is preferably 0.006~
0.008mm.The coating and liner layer 309 (PTFE) have good compatibility, have both ensured the fastness connected between layers
And reliability, migration or slip layer are prevented, and increase the flexibility of this section of pipe shaft.The 2x2 mesh grid of proximal end push section 301
Material preferably 304 stainless steels, braid angle α 2 be preferably 60 °, wherein proximal end push section 301 axial reinforced wire 3011a it is preferred
Semicircular structure, material preferably 304 stainless steels, diameter preferably 0.07~0.09mm；Middle-end supporting section 302 is preferred to strengthen helix
The external structure for being arranged elastic network(s) of circle, the material preferred nickel/titanium alloy of the elastic network(s), elastic mesh embed the preferred diamond shape of shape
Structure.PEBAX hardness preferably 63~74D of the surrounding layer 306 in proximal end push section 301, the PEBAX hardness of middle-end supporting section 302
It is preferred that 55~63D, PEBAX hardness preferably 40~55D of control section 303 is turned round in distal end, and the polyurethane hardness for surpassing distal end tracking section 304 is excellent
Select 60~85A.The thickness of surrounding layer preferably 0.08~0.12mm.
In the embodiment, the maximum value of the internal diameter of the proximal end push section 301 and middle-end supporting section 302 of intermediate conductor is reachable
1.65~1.70mm, the Maximum constraint of outer diameter are 1.8~2.2mm；It turns round control section 303 and surpasses the interior of distal end tracking section 304 in distal end
The maximum value of diameter is 1.95~2.1mm up to 1.40~1.52mm, the Maximum constraint of outer diameter.By clinical data it is found that centre
The vessel diameter range that conduit has cavernous segment in the neck of challenge (C4 sections) to this section of middle cerebral artery M 1 segment is 2.5
~3.5mm.Therefore the intermediate conductor has satisfaction to pass through the basic condition that distal vessels reach M1 sections in outer diameter, and proximal end pushes away
The mesh grid of the three-dimensional structure of section 301 is sent to have excellent radial support and axial pushability；Middle-end supporting section 302 uses axis
It is arranged the structure of elastic network(s) to outside the spiral winding (strengthening spiral winding) of reinforcement, has excellent fold resistance and supportive, energy
Good fitting blood vessel；It turns round control section 303 and surpasses distal end tracking section 304 by adjusting the pitch of spiral winding, filling in distal end
The material and hardness of polymer increase the measures such as internal layer strong flexible polymer coating, adjustment coating layer thickness, so that control section is turned round in distal end
303 have excellent kink resistance and flexibility, and super distal end tracking section 304 has excellent flexibility, and cooperation can steam moulding
Soft catheter tip, can be realized and pass through the complicated tortuous blood vessel of encephalic and (can especially pass through that C3 siphon in neck is curved and the sea C4
Continuous sinus section) purpose.The internal diameter upper limit value of the intermediate conductor can match up to 1.70mm (5.1F), cavity and convey city
Most microtubular on face takes bolt instrument (such as intracranial stent, blood flow reconstruction device etc.) to middle cerebral artery M 1 segment or more distal end
Intracranial vessel, auxiliary complete diagnosis or treatment cranial vascular disease.
Application characteristic according to the present utility model provides a kind of quickly removal entocranial artery vascular thrombosis, acute to treat
The intermediate conductor of Ischemic Stroke.In one embodiment, the intermediate conductor forms leading for aspirate thrombi with external suction pump
Guard system, design be used in a variety of different blood vessels and use (such as internal carotid, M1, M2 sections of arteria cerebri media, basal arteries,
Vertebral artery etc.), so that providing a kind of operator does not need by or introduces the device for taking bolt instrument that thrombus removal can be completed.Cause
This, doctor is not needed to take pin device in operation or (as needed pre- air-discharging using balloon guide catheter, be filled using other conduits
With shrink sacculus) etc. the time is lost on additional steps, and the exactly typical mechanical thrombectomy of these steps (uses encephalic branch
Frame etc. carries out machinery and takes bolt) required for.Therefore, the conduit system of the aspirate thrombi for doctor provide one quickly, have
The mode of the treatment acute ischemic stroke of effect.Operating procedure is as shown in the table:
It, can compared to typical mechanical thrombectomy using the thrombus of intermediate conductor draw target blood vessel in the embodiment
Save treatment acute ischemic stroke operating procedure and operating time, and reduce the instrument in surgical procedure use (such as
That uses in mechanical thrombectomy takes pin device, balloon guide catheter, microtubular and the seal wire for guiding balloon guide catheter
Deng), economic cost is saved for patient.
Claims (13)
1. a kind of intermediate conductor, including by proximal end to the seat (1), stress release pipe (2) and conduit (3) distally set gradually；Its
It is characterized in that,
Conduit (3) is along axial direction by closely to being far distributed with, proximal end push section (301), middle-end supporting section (302), distally section is controlled in torsion
(303) and super distal end tracks section (304)；Catheter tip (4) and super distal end tracking section (304) are coaxially connected；Seat (1) duct with
The coaxial of conduit (3) connects into lead-in cavity (1301)；
Liner layer (309), intermediate strengthening layer (308) and surrounding layer (306) is radially distributed in conduit (3) from the inside to the outside, described
Intermediate strengthening layer (308) is connected with liner layer (309) and surrounding layer (306) respectively.
2. intermediate conductor as described in claim 1, which is characterized in that
The material of liner layer (309) is PTFE, and elongation is 40%~50%, and thickness range is 0.005~0.03mm.
3. intermediate conductor as described in claim 1, which is characterized in that
Proximal end pushes the intermediate strengthening layer of section (301) using reinforcing mesh grid (3011)；The reinforcing mesh grid (3011) includes
Oblique braided wires and axial reinforced wire are knitted to form.
4. intermediate conductor as claimed in claim 3, which is characterized in that
Reinforcing mesh grid (3011) increases axial reinforced wire, constitutes on the basis of the mesh grid that the oblique braided wires of 2x2 are weaved into
The reinforcing mesh grid of three-dimensional structure；Axial reinforced wire (3011a) is axially laid along conduit (3), in two oblique braided wires
(3011b, 3011c) infall passes through among two oblique braided wires；Strengthen mesh grid (3011) pitch d1 along axial direction by
Closely to being far gradually incremented by；
The pitch d1 for strengthening mesh grid (3011) is 0.05mm~0.7mm, and strengthens the pitch d1 of mesh grid (3011) along axis
To by closely to being far gradually incremented to 0.7mm from 0.05mm.
5. intermediate conductor as claimed in claim 4, which is characterized in that
Strengthening angle α 2 formed by the oblique braided wires and conduit radial direction of mesh grid (3011) is 30 °~65 °.
6. intermediate conductor according to any one of claims 1 to 3, which is characterized in that
The intermediate strengthening layer (308) of middle-end supporting section (302) is arranged elastic network(s) using spiral winding, alternatively, middle-end supporting section
(302) intermediate strengthening layer (308) includes that axial reinforced wire and spiral shell that mesh grid extension comes are strengthened in proximally push section (301)
Spin line circle, which is constituted, strengthens spiral winding, is arranged the elastic network(s) in the reinforcing spiral winding.
7. intermediate conductor as claimed in claim 6, which is characterized in that
Be distributed with elastic mesh on elastic network(s), the shape of elastic mesh is ellipse, embedded in ellipse cruciform shape or
Diamond structure, embed the long and short axis of shape respectively with elliptical long and short overlapping of axles, long axis direction along conduit it is axial uniformly point
Cloth, short-axis direction are uniformly distributed along the circumferencial direction of conduit.
8. intermediate conductor as claimed in claim 7, which is characterized in that
Elastic mesh is 0.15~0.9mm, width range of the elastic mesh along conduit circumferential direction along the pitch d2 range of conduit axial direction
For 0.1~0.3mm, the wall thickness range of elastic network(s) is 0.01~0.2mm.
9. intermediate conductor according to any one of claims 1 to 3, which is characterized in that
It includes spiral winding that control section (303) and the strengthening layer (308) of super distal end tracking section (304) are turned round in distal end, alternatively, control is turned round in distal end
The strengthening layer (308) of section (303) and super distal end tracking section (304) includes that the spiral winding and proximal end push section (301) are strengthened
Mesh grid extends the reinforcing spiral winding that the axial reinforced wire to come is constituted；The gap filling of spiral winding has strong flexible polymer
(308a), the internal layer and/or outer layer of spiral winding, which are coated with, has the high-elastic of compatibility with the strong flexible polymer (308a)
Property polymer coating (307).
10. intermediate conductor as claimed in claim 9, which is characterized in that
Strong flexible polymer (308a) uses copoly type thermoplastic elastomer (TPE) or mechanical blending type thermoplastic elastomer (TPE)；Wherein, far
Strong flexible polymer (308a) shore hardness that control section (303) is turned round at end is 30D~55D；Super distal end tracks the high resiliency of section (304)
Polymer (308a) shore hardness is 40A~85A；
Strong flexible polymer coating (307) material is copoly type thermoplastic elastomer (TPE)；
When the strong flexible polymer coating (307) is applied only to the spiral winding outer layer, thickness range be 0.01~
0.1mm；When being applied only to spiral winding internal layer, thickness range is 0.001~0.02mm；Internal layer coated in spiral winding and outer
When layer, the range of coat thicknesses coated in outer layer is 0.001~0.03mm, and the range of coat thicknesses coated in internal layer is 0.001
~0.01mm.
11. intermediate conductor as claimed in claim 9, which is characterized in that
The pitch range that control section (303) spiral winding (3031) is turned round in distal end is 0.1mm~0.7mm, turns round control section (303) edge in distal end
Conduit is axial by closely to remote decreasing pitch；
The pitch range of super distal end tracking section (304) spiral winding (3041) is 0.01mm~0.5mm, in super distal end tracking section
(304) along axial direction by closely to remote decreasing pitch.
12. intermediate conductor according to any one of claims 1 to 3, which is characterized in that
Catheter tip (4) uses the polyurethane material of line style flexible macromolecule modification by copolymerization；The shape of catheter tip is straight circular cone
Shape or length are curved.
13. intermediate conductor according to any one of claims 1 to 3, which is characterized in that
The distal end of super distal end tracking section (304) is provided with developing ring (305) or super distal end tracking section (304) proximally and distally
It is each provided with developing ring (305)；
It is set outside the hollow out ring structure (3051) or developing ring of the axially aligned regular rectangular shape hole of developing ring (305) use
There are rectangular toothed structure (3052).
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201821644536.7U CN209575486U (en) | 2018-10-10 | 2018-10-10 | Intermediate conductor |
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|---|---|---|---|
| CN201821644536.7U CN209575486U (en) | 2018-10-10 | 2018-10-10 | Intermediate conductor |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109173003A (en) * | 2018-10-10 | 2019-01-11 | 江苏尼科医疗器械有限公司 | Intermediate conductor |
| CN110947077A (en) * | 2019-12-02 | 2020-04-03 | 心凯诺医疗科技(上海)有限公司 | High-flexibility distal access guiding catheter and preparation method thereof |
| CN113893435A (en) * | 2021-10-14 | 2022-01-07 | 艾柯医疗器械(北京)有限公司 | Medical catheter |
| WO2023045043A1 (en) * | 2021-09-26 | 2023-03-30 | 惠州海卓科赛医疗有限公司 | Medical tube |
-
2018
- 2018-10-10 CN CN201821644536.7U patent/CN209575486U/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109173003A (en) * | 2018-10-10 | 2019-01-11 | 江苏尼科医疗器械有限公司 | Intermediate conductor |
| CN109173003B (en) * | 2018-10-10 | 2024-04-09 | 江苏尼科医疗器械有限公司 | Intermediate catheter |
| CN110947077A (en) * | 2019-12-02 | 2020-04-03 | 心凯诺医疗科技(上海)有限公司 | High-flexibility distal access guiding catheter and preparation method thereof |
| WO2023045043A1 (en) * | 2021-09-26 | 2023-03-30 | 惠州海卓科赛医疗有限公司 | Medical tube |
| CN113893435A (en) * | 2021-10-14 | 2022-01-07 | 艾柯医疗器械(北京)有限公司 | Medical catheter |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| IP01 | Partial invalidation of patent right |
Commission number: 5W122536 Conclusion of examination: Declare claims 1-5, 12, and 13 of utility model number 201821644536.7 invalid, and continue to maintain the validity of this patent right on the basis of claims 6-11 Decision date of declaring invalidation: 20210625 Decision number of declaring invalidation: 50324 Denomination of utility model: Intermediate catheter Granted publication date: 20191105 Patentee: Jiangsu Nico Medical Equipment Co.,Ltd. |
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| IP01 | Partial invalidation of patent right |