CN105105894A - Reinforced compound sheathing canal, preparation method and application thereof - Google Patents
Reinforced compound sheathing canal, preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a reinforced compound sheathing canal, a preparation method and application thereof. The reinforced compound sheathing canal sequentially comprises an inner layer, a reinforced layer and an outer layer from interior to exterior, wherein the reinforced layer comprises axial reinforcing elements and a spiral reinforcing element, the spiral reinforcing element is a single spiral element or is formed by combining two or more spiral elements, the axial reinforcing elements are disposed on the inner side or outer side of the spiral element, or are inserted between the spiral elements, and various axial reinforcing elements are uniformly arranged in the circumference direction of the sheathing canal. The reinforced compound sheathing canal provided by the invention has the advantages of thin wall, high axial strength, high radial strength, high torque transitivity and the like, can be applied to a transport system for transporting medical device implants needed in a minimally invasive treatment and can reduce the outer diameter of the transport system, so that the medical device implants are easy to arrive at lesion positions, damage to the blood vessel of a patient is reduced, and sufficient technical support is provided for reliable, successful and safe transport and implantation of the medical device implants by the transport system.
Description
Technical field
The present invention relates to technical field of medical instruments, particularly relate to the compound sheath pipe of enhancing that a kind of intervention apparatus conveying system is generally applied.
Background technology
Minimally Interventional Therapy is a kind of operative treatment mode of carrying out under image-guided, during operation by induction system with minimum wound by medical apparatus and instruments implant or drug conveying to lesion locations, to carry out physics, machinery or chemotherapy to it.Wherein, sheath pipe, as the important component part of induction system, is widely used in Minimally Interventional Therapy.
For the Minimally Interventional Therapy of blood vessel class, operation doctor usually does Anatomical planes at thin vessels (as femoral artery place) or implements paracentesis and forms entrance, then by induction system through the passage such as entrance and thin vessels by medical apparatus and instruments implants such as overlay film frames, be transported to the target lesion positions such as coronary artery, aortic valve, thoracic aorta, ventral aorta, entocranial artery, carotid artery.Because the medical apparatus and instruments implants such as overlay film frame have the features such as profile (profile) is large, radial support power is large, and the diameter of the passage such as porch and thin vessels only has several millimeters, especially for the case of some lumen of vessels calcifications, its passage will become more narrow, therefore, an urgent demand is enough little for the section profile loading the induction system of medical apparatus and instruments implant, and profile and the external diameter of sheath pipe self all will decrease, to reduce the wound to patient vessel.On the other hand, sheath pipe must provide sufficiently high radial strength again, make the medical apparatus and instruments implants such as overlay film frame can be loaded in sheath pipe, and need to provide sufficiently high axial strength, so that the medical apparatus and instruments implants such as overlay film frame can be released in sheath pipe, thus the safety realizing medical apparatus and instruments implant is implanted.The application demand of the above-mentioned two relative contradictions in aspect, the stuctures and properties for sheath pipe proposes comparatively strict requirement.
Application number be 201210140431.9 patent " multiple tube and comprise the intervention apparatus conveying system of this multiple tube " disclose the design of a kind of composite pipe structure, its main feature is between ectonexine, arrange an enhancement Layer, and one end of enhancement Layer is the structure with axial support power and radial elastic.But the design of this multiple tube to enhancement Layer structure is unreasonable, and the section profile (profile) of multiple tube is little not enough, radial and transverse strength is also large not.Therefore, be necessary for further study to the structure of sheath pipe and improve, to meet the application demand of Minimally Interventional Therapy better.
Summary of the invention
The object of the present invention is to provide the compound sheath pipe of a kind of enhancing, and the Preparation method and use of the compound sheath pipe of this enhancing, be intended to the axial strength and the radial strength that improve sheath pipe, reduce induction system external diameter, make induction system more easily arrive lesion locations, ensure that medical apparatus and instruments implant can be implanted safely.
Technical solution of the present invention is: the compound sheath pipe of a kind of enhancing, comprise the internal layer, enhancement Layer and the skin that arrange from inside to outside successively, described enhancement Layer comprises axial reinforcing element and spiral reinforcement member, wherein: described spiral reinforcement member is single helical element, or combined by two or more helical element race; Described axial reinforcing element, is placed in inner side or the outside of helical element or helical element race, or interts between helical element or helical element race, and each axial reinforcing element is evenly distributed along sheath pipe circumferencial direction, forms axial member race.
Preferably, in the middle of the compound sheath pipe of above-mentioned enhancing, described spiral reinforcement member is single helical element, forms the helical structure of coil shape; Or comprise the helical element of the contrary coil shape of both direction, form the levels cover type braiding structure of lattice-shaped; Or comprise two or more helical element, form the interlacing structure of lattice-shaped.
And the screw element that the partial-length of described sheath pipe comprises is single helical element, and remainder is then two or more helical element race; The far-end of described sheath pipe carries out reducing design, and the near-end of sheath pipe carries out enlarging design.
Further, the compound sheath pipe of aforesaid enhancing, wherein: described internal layer or skin are single or multiple lift macromolecular material, when adopting multiple structure, macromolecular material both can be the same or different; Further, internal layer and outer field material both can be the same or different; Containing developability material in described outer macromolecular material, and be provided with development point or developing ring at sheath pipe far-end, the position of development point or developing ring is positioned at the far-end of enhancement Layer, and by internal layer with outer to wrap up.
Further, the compound sheath pipe of aforesaid enhancing, wherein: the material of described spiral reinforcement member and axial reinforcing element is the combination of macromolecular material, metal material or macromolecular material and metal material, the form of material is the one in silk, line, fiber, monofilament, multifilament, cable, and the material of described two kinds of elements both can be the same or different.Preferred version is, described axial reinforcing element and spiral reinforcement member are liquid crystal polymer fiber.
The preparation method of the compound sheath pipe of aforementioned enhancing, key step is: spiral reinforcement member winding is formed the helical structure of coil shape or the braiding structure of braiding formation lattice-shaped, meanwhile, axial reinforcing element is placed in internal layer or the skin of spiral reinforcement member, or be placed between ectonexine spiral or braiding structure, said process carries out on mandrel or polymer tube, make it to form enhancement Layer, then by pyrocondensation, injection moulding, to extrude or the mode of coextrusion both sides inside and outside enhancement Layer form internal layer and skin, finally realize the integration of whole sheath pipe; When on polymer tube, processing forms enhancement Layer, this polymer tube is namely as the internal layer of sheath pipe.
More than strengthening the most important purposes of compound sheath pipe is: compound for this enhancing sheath pipe is applied in Minimally Interventional Therapy the induction system needing to carry medical apparatus and instruments implant.
Technical solution provided by the invention can cover more multiple-case, and meanwhile, operation risk can reduce by stable sheath tubular construction design greatly, and its significant technique effect is embodied in following many aspects---
1, the axial reinforcing element of the present invention's design has the following advantages:
The first, axial reinforcing element can prevent sheath pipe from extending and compression, doctor is operated when sheath pipe near-end applies pulling force and thrust to it in operation and keeps man-to-man response.
The second, axial reinforcing element overall buried enter two-layer between, at utmost limit axial reinforcing element and tubing integral shaft to relative motion, thus ensure that sheath pipe proximally arrive that far-end has an excellence turn round control transitivity.
3rd, by the axial reinforcing element race of ordered arrangement, such as evenly distributed along sheath pipe circumferencial direction, sheath pipe can obtain the homogeneous bending compliance on differently curved, when sheath pipe imports to tortuous vascular site, is conducive to the accurate control promoting sheath pipe.
4th, contrast with only using single axial reinforcing element, the axial reinforcing element race evenly distributed along sheath pipe circumferencial direction provides the isotropism of sheath pipe at circumferencial direction, reduces sheath pipe and is oppressed by blood or inner bending probability of loading when having the implant of superpower outside swelliong power.
5th, the rigidity of sheath pipe can evenly be strengthened, and is conducive to the hardness reducing sheath thickness of pipe wall or reduce sheath pipe ectonexine, and the profile minimizing of sheath pipe is achieved.
6th, axial reinforcing element can stop the radial dilatation of sheath pipe, makes the rupture strength of sheath pipe be able to remarkable enhancing.
7th, the design that axial reinforcing element interts between helical element, sheath inner tube layer or superficies projection can not be caused, simultaneously, axial reinforcing element can not be fixed with the macromolecule internal layer woven near reinforcing element or skin, thus retainer shaft is to the advantage of reinforcing element, avoid ectonexine rat to cause frictional force to increase, it also avoid itself and the shortcoming such as macromolecule internal layer or the outer limited curva fixedly caused simultaneously.
2, the present invention is flexible for the design comparison of spiral reinforcement member, spiral reinforcement member on whole sheath pipe both can be single helical element, also can be comprise two or more spiral ring element race, all right: partial-length is single helical element, and remainder is two or more helical element races.This design tool has the following advantages:
The first, the sheath pipe that the single helical element of sheath tube portion length can give this part has enough bending compliances, makes induction system more easily arrive lesion locations.
The second, two or more spiral ring element races of sheath pipe remainder still keep or improve the radial strength in this region.
3rd, the axial reinforcing element on whole root sheath pipe still can keep sheath pipe to have the axial strength of safe enough, and provides stronger radial strength.
3, on the whole, compared with the sheath pipe that routine uses at present, enhancing provided by the invention compound sheath pipe has: the advantages such as thin-walled, high axial strength, high radial strength, high moment of torsion transitivity, adopt this sheath pipe can reduce induction system external diameter, induction system is made more easily to arrive lesion locations, reduce the wound to patient vessel, for induction system reliably, successfully carries medical apparatus and instruments implant, and it is implanted safely provide sufficient technical guarantee.
Accompanying drawing explanation
Fig. 1 is the schematic diagram that the axial reinforcing element of the present invention is placed in the compound sheath inner tube layer of the present invention;
Fig. 2 is the schematic diagram that the axial reinforcing element of the present invention is placed between the present invention's compound sheath pipe ectonexine;
Fig. 3 is the schematic diagram that the axial reinforcing element of the present invention is placed in the compound sheath outer tube layer of the present invention;
Fig. 4 is the sheath pipe schematic diagram of the axial reinforcing element of the present invention between two knitting elements;
Fig. 5 is the axial sheath pipe schematic diagram of the reinforcing element outside two knitting elements (two coil elements are laminating up and down) of the present invention;
Fig. 6 is the axial sheath pipe schematic diagram of the reinforcing element outside two knitting elements (two taenidium interlacings) of the present invention.
In figure, the implication of each Reference numeral is: A-internal layer, B-enhancement Layer, C-skin; 1-spiral reinforcement member, 1a-the first helical element, 1b-the second helical element, 2-axial reinforcing element.
Detailed description of the invention
Sheath pipe is the important component part of Minimally Interventional Therapy induction system, for operation doctor, apart near be sheath pipe proximal end region, otherwise be then remote area.According to the difference of concrete operation for sheath pipe performance requirement, the rigidity of sheath pipe proximal end region and remote area both can be the same or different.Under normal circumstances, the ratio of rigidity remote area of proximal end region wants large, to provide better pushed forward performance; The compliance of remote area is better than proximal end region, to provide induction system by tracing property better during tortuous blood vessel.Propelling movement needed for induction system, tracing property or other performances, at proximal end region, or simultaneously at proximal end region and remote area, can use multi-layer structure design.
For this reason, the present invention proposes a kind of compound sheath pipe of enhancing of multiple structure, to improve the serviceability of sheath pipe, adapts to the application demand of Minimally Interventional Therapy operation.Below in conjunction with accompanying drawing, technical solution of the present invention is described in detail, makes it understand better and grasp.
As shown in FIG. 1 to 3, the compound sheath pipe of enhancing of the present invention, its structure comprises the internal layer A, enhancement Layer B and the outer C that arrange from inside to outside successively, and enhancement Layer B is placed between internal layer A and outer C.Wherein, internal layer A and outer C can be the macromolecular material of single or multiple lift, and when adopting multiple structure, the macromolecular material of each layer both can be the same or different.Enhancement Layer B is the place of the technology of the present invention key, and its structure composition comprises: spiral reinforcement member 1 and axial reinforcing element 2, and axial reinforcing element 2 overall can be placed in the inside (that is: being close to the outer surface of internal layer A) of spiral reinforcement member 1, as Fig. 1; Also can intert between spiral reinforcement member 1, as Fig. 2; Entirety can also be placed in the outside (that is: being close to the inner surface of outer C) of spiral reinforcement member 1, as Fig. 3.
According to technical solution of the present invention, spiral reinforcement member 1 can only comprise single helical element, form the helical structure of coil shape, also the coil screw element that both direction is contrary can be comprised, form the levels cover type braiding structure of lattice-shaped, plural helical element race can also be comprised, form the interlacing structure of lattice-shaped.For single helical element, winding process can be adopted to form the helical structure of coil shape, and the density of axially adjacent helical structure can be 30 ~ 50 circles/inch usually; For the coil screw element that both direction is contrary, form the levels cover type braiding structure of lattice-shaped, winding process can be adopted to form the helical structure of coil shape, and axially adjacent helical structure density can be 30 ~ 50 circles/inch usually, winding direction is contrary, and mutual angle is 50 ~ 130 degree; And for plural spiral ring element race, interlacing technique can be adopted to form the braiding structure of lattice-shaped, axially adjacent count can be 40 ~ 80ppi usually, usually selects 60ppi.
See Fig. 4 ~ Fig. 6, spiral reinforcement member 1 braiding defines the braiding structure (for illustrate better, only show two helical elements) of lattice-shaped.As shown in Figure 4, spiral reinforcement member 1 contains Liang Ge helical element race, i.e. the first helical element 1a and the second helical element 1b, and axial reinforcing element 2 interts at two between spiral reinforcement member 1a and 1b; Also can as shown in Figure 5 and Figure 6, axial reinforcing element 2 is positioned at outside spiral reinforcement member 1.Wherein, the mode of the braiding of Fig. 5 with Fig. 6 is not identical, and what Fig. 5 showed is that two coil linear elements are laminating up and down, and Fig. 6 display is that two taenidium interlacings form.
According to technical solution of the present invention, spiral reinforcement member (or spiral reinforcement member race) can adopt macromolecular material, metal material or both combinations, specific as follows:
If spiral reinforcement member uses macromolecular material, then available material comprises silk, line, fiber, monofilament, multifilament, cable, plastics etc.Preferably, select the fiber that intensity is good, quantity can be one or more.As shown in Figure 1, according to required performance, plurality of fibers can be melt into one or more strands of the structure selecting plurality of fibers, also can not carry out melting.Plurality of fibers is melt into one or more strands of, will provide the mechanical performance be similar to as solid bar, and the plurality of fibers of not melting, then the mechanical performance be similar to as cable is provided.The performance of cable is contrary with solid bar, and its compliance is better, and the fatigue resistance after simultaneously repeatedly bending is also better, is thus more suitable for the situation that blood vessel is tortuous.Preferably, obtaining the sheath pipe of thin-walled in order to reduce profile as far as possible, plurality of fibers can be formed flat structure side by side.
If use fiber, can select the fibers such as liquid crystal polymer, if the trade mark is the polyarylate fiber of Vectran, Unitika, Dnryl, the trade mark is the aramid fiber of Kevlar, also can select liquid crystal polymer composite.Normally, fibre section is circular, and diameter 0.0005 ~ 0.01 inch, the fiber of each spiral reinforcement member can comprise 2 to 40 fibers, preferentially, selects 20.In order to make fiber and other element frictional resistance minimumization, as sheath pipe, fiber and frock clamp inevitably rub to cause and fluff or fracture of wire phenomenon in the fabrication process, or sheath pipe rubs in stressed use procedure and between other elements and causes fracture of wire phenomenon, can select T-97, the lubricating oil such as T-150 carry out coating to fiber.
If spiral reinforcement member uses metal material, then available material comprise Nitinol, cochrome, platinumiridio, gold, rustless steel, tantalum or other, usually preferably low price, intensity is good, developability is good rustless steel.The spiral reinforcement member of metal material can be circular cross-section or square-section, this is depending on required performance (containing profile), such as, in order to reduce profile as much as possible, obtain the sheath pipe of thin-walled and high radial strength, height can be selected to be 0.001 inch, wide be the stainless steel flat wire of the square-section of 0.005 inch, simultaneously braiding head number (that is: number of spindles) be chosen as 16,32,64 first-class, wherein, select 16 to carry out 2 × 2(that is " on two twice ") interlacing mode be preferred version.At the end of the stainless steel silk braiding of single sheath pipe, the thin heat-shrink tube of wall (the PET heat-shrink tube as wall thickness 0.0005 inch) can be used to be fixed braided wires head, to stick up silk to prevent silk head place and make the surfaces externally and internally in this region of sheath pipe produce protruding phenomenon.
Similar to spiral reinforcement member, axial reinforcing element also can adopt macromolecular material, metal material or both combinations, generally selects the raw material of high strength, low extension.Usually, axial reinforcing element race is along the axial reinforcing element race of the evenly distributed formation of sheath pipe circumferencial direction, and the axial reinforcing element quantity that this race uses can be Arbitrary Digit, concrete number is depending on the specific performance of sheath pipe (axial strength etc.), as 4,8,10,12,16 etc. can be used, correspondingly, adjacent shaft is respectively 90 to reinforcing element along the angle of sheath pipe circumferencial direction
°, 45
°, 36
°, 30
°, 22.5
°deng.Preferably, in order to reduce the profile of sheath pipe as much as possible, obtaining the sheath pipe of thin-walled, liquid crystal polymer fiber can be selected, and plurality of fibers is formed flat structure side by side.
The feature of this high strength of axial reinforcing element, low extension, effectively can prevent operating doctor and operate sheath pipe near-end to its applying pulling force to discharge sheath pipe extension during medical apparatus and instruments implant, and the axial compression of sheath pipe during applied thrust, guarantee the one_to_one corresponding of doctor's operational motion and response action.Simultaneously, axial reinforcing element due to sheath pipe has the feature of high strength, low extension, also give the feature of sheath pipe high strength and low extension, make sheath pipe can obtain accurate controlling and importing property, ensure that medical apparatus and instruments implant is able to safe release and implantation.In addition, the axial design of reinforcing element between helical element (as shown in Figure 2), sheath inner tube layer or superficies projection can not be caused, avoid the shortcoming of all the other macromolecule internal layers or the outer limited curva fixedly caused, the frictional force that it also avoid medical apparatus and instruments implant that internal layer rat causes and sheath inner tube layer increases, or the sheath pipe that causes of superficies projection increases with the frictional force of blood vessel wall, thus carrying out smoothly of ensureing to perform the operation, and the wound of reduction to patient vessel.
The present invention passes through along the axial reinforcing element race of the evenly distributed formation of sheath pipe circumferencial direction, sheath pipe can obtain the more homogeneous bending compliance on differently curved, axial reinforcing element quantity is more, the plane of even compliance is also more, when sheath pipe imports to tortuous vascular site, be more conducive to accurately controlling sheath pipe.With only use single axle to compared with reinforcing element, along the axial reinforcing element race that sheath pipe circumferencial direction is evenly distributed, reduce sheath pipe and oppressed by blood or inner bending probability of loading when there is the implant of superpower outside swelliong power.On the other hand, axial reinforcing element or axial reinforcing element race are set, the bonding strength between adjacent elements in sheath pipe can be improved, increase the rupture strength of sheath pipe, prevent the radial dilatation of sheath pipe, also enhance the rigidity of sheath pipe, thus can reduce the hardness of sheath thickness of pipe wall or reduction sheath pipe ectonexine macromolecular material, the profile minimizing of sheath pipe is achieved simultaneously.
According to technical solution of the present invention, described internal layer polymer material layer can be made up of the macromolecular material of self-lubricating, and the material that can select comprises but is not limited only to: fluoroplastics, contains PTFE, FEP, PFA, PCTFF, ECTFE, ETFE, PVDF, PVF etc.; Polyolefin, contains LDPE, HDPE, UHMWPE etc.; In addition, Pebax, PA, PU etc. can also be adopted.For the material that lubricity is bad, as Pebax, PA, PU etc., optionally within it layer carries out hydrophilic coating (as PVP) or hydrophobic coating (as silicone oil) process, to reduce medical apparatus and instruments implant at the excessive frictional resistance of sheath inner tube layer.Internal layer can by injection moulding, extrude or co-extrusion modling, or by coating process molding, or manufactured by other known tubing manufacturing technologies.In order to improve the attachment force/bonding force between internal layer and skin, surface treatment can be carried out to inner layer outer surface in advance, to improve the surface activity of inner layer outer surface, as passed through Cement Composite Treated by Plasma, surface etching technology etc.
Similarly, the available material of outer polymer material layer of the present invention comprises but is not limited only to: polyolefin, contains LDPE, HDPE, UHMWPE etc., and also comprising is Pebax, PA, PU etc.Outer by injection moulding, extrude or co-extrusion modling, or to be manufactured by other known tubing fabrication technique.Preferably, in order to reduce the profile of sheath pipe to greatest extent, the tubing of wall thickness relatively thin (0.001 ~ 0.003 inch) can be selected as inner layer material.For the material that lubricity is bad, as Pebax, PA, PU etc., optionally carry out hydrophilic coating (as PVP) or hydrophobic coating (as silicone oil) process at its skin, or coating self lubricity fluoroplastics, as PTFE etc., to reduce frictional resistance larger between sheath pipe and lumen of vessels inwall.In order to improve the attachment force/bonding force between skin and coating, surface treatment can be carried out to outer outer surface in advance, to improve the surface activity of outer outer surface, as passed through Cement Composite Treated by Plasma, surface etching technology etc.
In addition, can contain developability material in outer macromolecular material, employing content is the barium sulfate, bismuth oxide etc. of 20 ~ 60% usually.For the hardness of outer macromolecular material, can be designed as and successively decreased successively to far-end by the near-end of sheath pipe, as sheath pipe proximal part selects hardness to be Pebax or the PU material of 72HD, and sheath pipe distal portions selects Pebax or the PU material of 25HD, 35HD or 55HD, also marginal Pebax or the PU material of hardness can be selected at the mid portion of sheath pipe.By this design, the rigidity of sheath pipe is successively decreased, and serviceability is better.When sheath pipe intravasation inside cavity, in order to the position making operation doctor accurately judge sheath pipe far-end, usually can use development point or developing ring etc. at sheath pipe far-end, to make sheath pipe far-end, there is developability.Developability material can select iridium, platinumiridio, gold, tungsten, tantalum or other alloys etc., and development point or the position of developing ring are generally positioned at the far-end of enhancement Layer, and by internal layer with outer to wrap up.
In order to the far-end reducing induction system is when Ink vessel transfusing imports and the damage of blood vessel wall, reducing design can be carried out to sheath pipe distal portions, to reduce the gap between parts (as Tip head) that sheath Guan Yuqi inner chamber coordinates to greatest extent, make both seamlessly transit.For near-end, near-end for ease of induction system realizes safe and effective connection with sheath pipe, enlarging design can be carried out, to increase the contact area between parts (as sheath pipe joint) that sheath pipe proximal part coordinates with its outer surface to greatest extent to sheath pipe proximal part.
Near-end enlarging technique has multiple method to select, and conventional have two kinds: one to be the mandrel of design one given shape, is enclosed within above this mandrel, is then heated to sheath pipe near-end uniform temperature and makes it form horn mouth; Two is directly select the material (as Pebax, PA etc.) similar or identical with sheath outer tube layer material, at the join domain of sheath pipe proximal part, directly makes it form required parts (as sheath pipe joint) by techniques such as injection mouldings.Select similar or identical material to carry out injection moulding, can ensure to be connected safely and effectively between the near-end of induction system with sheath pipe.
Above abundant description is carried out to a structure of bright enhancing compound sheath pipe and details, constantly explore through inventor and study, the preparation process of the compound sheath pipe of this enhancing is: first, spiral reinforcement member winding is formed the helical structure of coil shape or the braiding structure of braiding formation lattice-shaped, meanwhile, axial reinforcing element is placed in internal layer or the skin of spiral reinforcement member, or be placed between ectonexine spiral or braiding structure, preferably, axial reinforcing element is evenly distributed along sheath pipe circumferencial direction.Said process carries out on mandrel or polymer tube, makes it to form enhancement Layer; Then by pyrocondensation, injection moulding, to extrude or the mode of coextrusion both sides inside and outside enhancement Layer form internal layer and skin, finally realize the integration of whole sheath pipe.When on polymer tube, processing forms enhancement Layer, this polymer tube is namely as the internal layer of sheath pipe.
In the middle of preparation process, internal layer and/or skin can be prefabricated, and obtain from suppliers, its form can be cut long segmentation tubing, also can be the continuous tubing of rolled.Can reel on the internal layer helical structure that forms coil shape or braiding of spiral reinforcement member forms the braiding structure of lattice-shaped, in this course, axial reinforcing element interts between spiral or braiding structure, or entirety is placed in inboard or the outside of spiral or braiding structure, then by being cut into target length.Next, development point or developing ring on certain correct position cover of sheath pipe distal portions, then skin is enclosed within enhancement Layer and (or) developing ring, and effectively coated both, then the adjuvant pipe of suitable material and size on overlapping again outside skin, as heat-shrink tubes such as FEP, PET, by suitable heating appliances, as Reflow equipment, at a proper temperature, as 190 ~ 270 DEG C, internal layer, enhancement Layer are connected with outer melting, finally remove adjuvant pipe, the sheath pipe of design can be obtained.After this, the sheath pipe of target length is obtained by cutting farm labourer's skill, recycle the mandrel designed and heating reducing process is carried out to the distal portions of sheath pipe, enlarging process is carried out to the proximal part of sheath pipe, and, according to ectonexine material and application demand, optionally coating process process is implemented to internal layer inner surface and outer outer surface, make the hydrophilic or hydrophobic coating of formation.
By above description; inventor has carried out fully open and detailed description to technical solution of the present invention; it should be noted that; the above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the prerequisite not departing from the technology of the present invention principle; can also make some improvement and modification, these improve and modification also should be considered as dropping within protection scope of the present invention.
Claims (10)
1. one kind strengthens compound sheath pipe, comprise the internal layer, enhancement Layer and the skin that arrange from inside to outside successively, it is characterized in that: described enhancement Layer comprises axial reinforcing element and spiral reinforcement member, wherein, described spiral reinforcement member is single helical element, or is combined by two or more helical element race; Described axial reinforcing element, is placed in inner side or the outside of helical element or helical element race, or interts between helical element or helical element race, and each axial reinforcing element is evenly distributed along sheath pipe circumferencial direction, forms axial member race.
2. the compound sheath pipe of enhancing according to claim 1, is characterized in that: described spiral reinforcement member is single helical element, forms the helical structure of coil shape; Or comprise the helical element of the contrary coil shape of both direction, form the levels cover type braiding structure of lattice-shaped; Or comprise two or more helical element, form the interlacing structure of lattice-shaped.
3. the compound sheath pipe of enhancing according to claim 1, is characterized in that: the screw element that the partial-length of described sheath pipe comprises is single helical element, and remainder is then two or more helical element race.
4. the compound sheath pipe of enhancing according to claim 1, it is characterized in that: the far-end of described sheath pipe carries out reducing design, the near-end of sheath pipe carries out enlarging design.
5. the compound sheath pipe of enhancing according to claim 1, is characterized in that: described internal layer or skin are single or multiple lift macromolecular material, and when adopting multiple structure, macromolecular material both can be the same or different; Further, internal layer and outer field material both can be the same or different.
6. the compound sheath pipe of enhancing according to claim 5, it is characterized in that: containing developability material in described outer macromolecular material, and, be provided with development point or developing ring at sheath pipe far-end, development point or the position of developing ring are positioned at the far-end of enhancement Layer, and by internal layer with outer to wrap up.
7. the compound sheath pipe of enhancing according to claim 1, it is characterized in that: the material of described spiral reinforcement member and axial reinforcing element is the combination of macromolecular material, metal material or macromolecular material and metal material, the form of material is the one in silk, line, fiber, monofilament, multifilament, cable, and the material of described two kinds of elements both can be the same or different.
8. the compound sheath pipe of enhancing according to claim 7, is characterized in that: described axial reinforcing element and spiral reinforcement member are liquid crystal polymer fiber.
9. described in claim 1, strengthen the preparation method of compound sheath pipe, it is characterized in that: spiral reinforcement member winding is formed the helical structure of coil shape or the braiding structure of braiding formation lattice-shaped, meanwhile, axial reinforcing element is placed in internal layer or the skin of spiral reinforcement member, or be placed between ectonexine spiral or braiding structure, said process carries out on mandrel or polymer tube, make it to form enhancement Layer, then pyrocondensation is passed through, injection moulding, to extrude or the mode of coextrusion both sides inside and outside enhancement Layer form internal layer and skin, finally realize the integration of whole sheath pipe, when on polymer tube, processing forms enhancement Layer, this polymer tube is namely as the internal layer of sheath pipe.
10. strengthen the purposes of compound sheath pipe described in claim 1 ~ 8 any one, it is characterized in that: compound for this enhancing sheath pipe is applied in Minimally Interventional Therapy the induction system needing to carry medical apparatus and instruments implant.
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| CN105943210A (en) * | 2015-12-23 | 2016-09-21 | 微创心脉医疗科技（上海）有限公司 | Intervention apparatus sheath tube and manufacturing method thereof |
| CN107296632A (en) * | 2016-04-15 | 2017-10-27 | 上海微创医疗器械（集团）有限公司 | Medical composite hollow fibre pipe and interventional medical device |
| CN107296670A (en) * | 2016-04-15 | 2017-10-27 | 上海微创医疗器械（集团）有限公司 | Medical composite hollow fibre pipe and interventional medical device |
| CN108066047A (en) * | 2016-11-15 | 2018-05-25 | 先健科技(深圳)有限公司 | Choked flow film and implanted medical device |
| CN108433853A (en) * | 2018-04-09 | 2018-08-24 | 浙江巴泰医疗科技有限公司 | A kind of novel more intensity multi-density sheaths |
| EP3395301A4 (en) * | 2015-12-23 | 2019-01-09 | MicroPort Endovascular (Shanghai) Co., Ltd. | Stent delivery system, assemblies thereof and use method therefor |
| CN109316269A (en) * | 2017-08-01 | 2019-02-12 | 恩脉（上海）医疗科技有限公司 | A kind of transport guard member, interventional therapy method and transport component |
| CN114454527A (en) * | 2022-02-11 | 2022-05-10 | 宁波琳晓生物科技有限公司 | Ultralow-shrinkage-temperature PEEK heat-shrinkable tube production equipment and application method thereof |
| WO2022166538A1 (en) * | 2021-02-05 | 2022-08-11 | 微创神通医疗科技（上海）有限公司 | Catheter reinforcement layer and catheter |
| WO2022267074A1 (en) * | 2021-06-25 | 2022-12-29 | 临海伟星新型建材有限公司 | Device and method for compounding reinforced composite pipe of completely bonded type |
| CN117563108A (en) * | 2024-01-16 | 2024-02-20 | 苏州汇禾医疗科技有限公司 | Vascular intervention medical instrument catheter and application |
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| CN105435314A (en) * | 2015-12-14 | 2016-03-30 | 李雷 | Preparation method of covered endovascular stent-graft |
| JP2019504722A (en) * | 2015-12-23 | 2019-02-21 | マイクロポート エンドヴァスキュラー （シャンハイ） カンパニー リミテッド | Stent delivery system, assembly thereof, and method of use thereof |
| CN105943213A (en) * | 2015-12-23 | 2016-09-21 | 微创心脉医疗科技（上海）有限公司 | Stent delivering system and use method thereof |
| CN105943210A (en) * | 2015-12-23 | 2016-09-21 | 微创心脉医疗科技（上海）有限公司 | Intervention apparatus sheath tube and manufacturing method thereof |
| EP3395301A4 (en) * | 2015-12-23 | 2019-01-09 | MicroPort Endovascular (Shanghai) Co., Ltd. | Stent delivery system, assemblies thereof and use method therefor |
| CN107296632A (en) * | 2016-04-15 | 2017-10-27 | 上海微创医疗器械（集团）有限公司 | Medical composite hollow fibre pipe and interventional medical device |
| CN107296670A (en) * | 2016-04-15 | 2017-10-27 | 上海微创医疗器械（集团）有限公司 | Medical composite hollow fibre pipe and interventional medical device |
| CN107296670B (en) * | 2016-04-15 | 2024-02-20 | 浙江脉通智造科技(集团)有限公司 | Medical composite hollow fiber tube and interventional medical instrument |
| CN108066047A (en) * | 2016-11-15 | 2018-05-25 | 先健科技(深圳)有限公司 | Choked flow film and implanted medical device |
| CN109316269A (en) * | 2017-08-01 | 2019-02-12 | 恩脉（上海）医疗科技有限公司 | A kind of transport guard member, interventional therapy method and transport component |
| CN109316269B (en) * | 2017-08-01 | 2021-06-22 | 恩脉（上海）医疗科技有限公司 | Transport protection piece and transport subassembly |
| CN108433853A (en) * | 2018-04-09 | 2018-08-24 | 浙江巴泰医疗科技有限公司 | A kind of novel more intensity multi-density sheaths |
| WO2022166538A1 (en) * | 2021-02-05 | 2022-08-11 | 微创神通医疗科技（上海）有限公司 | Catheter reinforcement layer and catheter |
| WO2022267074A1 (en) * | 2021-06-25 | 2022-12-29 | 临海伟星新型建材有限公司 | Device and method for compounding reinforced composite pipe of completely bonded type |
| CN114454527A (en) * | 2022-02-11 | 2022-05-10 | 宁波琳晓生物科技有限公司 | Ultralow-shrinkage-temperature PEEK heat-shrinkable tube production equipment and application method thereof |
| CN117563108A (en) * | 2024-01-16 | 2024-02-20 | 苏州汇禾医疗科技有限公司 | Vascular intervention medical instrument catheter and application |
| CN117563108B (en) * | 2024-01-16 | 2024-04-05 | 苏州汇禾医疗科技有限公司 | Vascular intervention medical instrument catheter and application |
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Application publication date: 20151202 |