Summary of the invention
It is an object of the present invention to provide a kind of conduits of adjustable hardness, and the conduit hardness is adjustable, and compliance is good,Flexibility and versatility are higher.
It is another object of the present invention to provide a kind of intervention devices, and the intervention device therapeutic effect is good, can be quickComplete intervention operation.
To achieve this purpose, the present invention adopts the following technical scheme:
A kind of conduit of adjustable hardness, comprising:
Catheter body is provided with hardness adjustment hole in the catheter body；
Hardness adjusts body, and the hardness is optionally provided in the hardness adjustment hole and adjusts body, the hardness tuneSection body is at least partly configured to be plugged to the hardness for increasing the conduit in the hardness adjustment hole, and described hardDegree adjusting body is at least partly configured to detach out of described hardness adjustment hole to reduce the hardness of the conduit.
Preferably, the quantity of the hardness adjustment hole be it is multiple, each hardness adjustment hole is along the conduit sheetThe axial setting of body.
Preferably, the hardness adjust body quantity be it is multiple, in each hardness adjustment hole can grafting at leastOne hardness adjusts body.
Preferably, the cross sectional shape of multiple hardness adjustment holes is different, the hardness adjustment hole and position are in the innerThe shape that the hardness adjusts body is adapted.
Preferably, the catheter body includes the lubrication inner tube that successively nesting is arranged from inside to outside, support middle tubeAnd outer tube, the hardness adjustment hole are arranged in the outer tube.
Preferably, being provided with hydrophilic lubrication coating in the outer tube.
Preferably, the catheter body includes straightway and bending section, the bending section is arranged in two neighboring straight lineBetween section, the bending section is configured to keep the two neighboring straightway in parallel or conllinear.
Preferably, the conduit of the adjustable hardness further include:
One end of the catheter body is arranged in attachment base, the attachment base, be provided on the attachment base with it is described hardThe insertion hole of adjustment hole connection is spent, the insertion hole adjusts body for being inserted into the hardness.
Preferably, the conduit of the adjustable hardness further include:
Protection pipe, the protection pipe are arranged between the catheter body and the attachment base, are arranged in the protection pipeThere is stress relief structure.
A kind of intervention device, the conduit including above-mentioned adjustable hardness.
Beneficial effects of the present invention:
The present invention provides a kind of conduit of adjustable hardness, which includes that catheter body and hardness adjust body, conduitThe hardness adjustment hole for capableing of grafting hardness adjusting body is provided on ontology.When hardness, which adjusts body grafting, to be entered in hardness adjustment holeIt is capable of increasing the hardness of conduit, the hardness of conduit can be reduced when hardness adjusting body pulls out out of hardness adjustment hole and.AndBody can partly or completely grafting enters in catheter body according to demand for hardness adjusting, and the different parts of conduit is made to have differenceHardness.Conduit provided by the invention can adjust hardness number according to use demand, over the course for the treatment of with suitable stiffnessConduit is convenient for through pathological tissues, and moving direction is controllable, and compliance is good, and flexibility is high and versatility is high, not only contribute to quickly,It is efficiently completed operation, and surgical effect is preferable, restored convenient for patient's later period.
Specific embodiment
Technical solution of the present invention is clearly and completely described below in conjunction with attached drawing, it is clear that described implementationExample is a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, ordinary skillPersonnel's every other embodiment obtained without making creative work, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that term " center ", "upper", "lower", "left", "right", "vertical",The orientation or positional relationship of the instructions such as "horizontal", "inner", "outside" be based on the orientation or positional relationship shown in the drawings, merely toConvenient for description the present invention and simplify description, rather than the device or element of indication or suggestion meaning must have a particular orientation,It is constructed and operated in a specific orientation, therefore is not considered as limiting the invention.In addition, term " first ", " second ", onlyFor descriptive purposes, it is not understood to indicate or imply relative importance.Wherein, term " first position " and " second position "For two different positions.
In the description of the present invention, it should be noted that unless otherwise clearly defined and limited, term " installation ", " phaseEven ", " connection " shall be understood in a broad sense, for example, it may be being fixedly connected, may be a detachable connection；It can be mechanical connection,It is also possible to be electrically connected；It can be directly connected, can also can be inside two elements indirectly connected through an intermediaryConnection.For the ordinary skill in the art, can be understood with concrete condition above-mentioned term in the present invention specifically containJustice.
A kind of conduit of adjustable hardness is present embodiments provided, which can be used for minimally invasive hand as means of transportationIn art, to assist doctor to complete the interventional therapy to patient.As shown in Figures 1 to 5, which includes catheter body 1 and hardnessBody 2 is adjusted, catheter body 1 is the tubular structure for being internally provided with cavity, and it is rod-like structure that hardness, which adjusts body 2,.In catheter body 1It is provided with hardness adjustment hole 11, hardness adjustment hole 11 can be blind hole, or through-hole, hardness adjustment hole 11 is preferably along conduitThe axis direction of ontology 1 is extended.Hardness adjusts body 2 and is optionally provided in hardness adjustment hole 11.Due to hardness tuneSaving body 2 has certain hardness, when hardness, which adjusts body 2, to be plugged in hardness adjustment hole 11, adjusts compared to not set hardnessThe part of body 2, the hardness that the part that hardness adjusts body 2 is provided on conduit increase；When hardness adjusts body 2 from hardness adjustment hole 11When inside detaching, compared to the part for being provided with hardness adjusting body 2, the hardness for the part that not set hardness adjusts body 2 on conduit subtractsIt is small.It should be noted that when, grafting or detach hardness adjust body 2 when, doctor can selected section grafting, part according to demandIt detaches, whole grafting or all detach, so that the different parts of conduit have different hardness.
In the present embodiment, by catheter body 1 be arranged hardness adjustment hole 11, and according to the process of interventional therapy withAnd demand in hardness adjustment hole 11 grafting or detach hardness adjust body 2, it will be able to reach and adjust the hardness of conduit to notWith value, make conduit that there is the purpose for the hardness for being most suitable for the treatment process.Compared to the immutable conduit of hardness, variable hardnessThe compliance of conduit is good, and flexibility and versatility are high, not only contributes to fast and efficiently complete to perform the operation, additionally it is possible to improve operationEffect is restored convenient for patient's later period.Also, letter is not only operated by the hardness that the method that plug hardness adjusts body 2 changes conduitSingle, controllability is high, and the adjustable range of hardness is wider.
Specifically, as shown in Figure 1 and Figure 4, it is using bar made of metal material or high molecular material that hardness, which adjusts body 2,Shape structure.Metal material can be metal wire material, such as titanium-nickel wire (NiTi) or stainless steel wire etc..Using high molecular material orHardness made of person's metal material, which adjusts body 2 itself, has certain toughness and support hardness.Preferably, hardness adjusts oneself of body 2Body hardness is greater than the hardness of former catheter body 1 (when not set hardness adjusts body 2).
As shown in Figures 3 to 8, catheter body 1 is cylindrical-shaped structure, sets the cylindric of no corner angle for catheter body 1Structure can be improved the conduit smoothness mobile in patient's body, and conduit is avoided to scratch the normal tissue of patient's body.Conduit sheetThe external diametrical extent of body 1 is preferably in 0.5mm-4mm, such as can be 0.5mm, 1mm, 2mm, 2.5mm, 3mm, 3.6mm or 4mm.One end that catheter body 1 protrudes into patient's body has arc structure, and the end that arc structure can be avoided conduit scratches patient's bodyInterior normal tissue.And for the ease of being used cooperatively with external image equipment, enables the surgeon to enough conduits of clearly grasping and suffering fromPerson intracorporal position is additionally provided with X-ray opaque material in catheter body 1, which can be heavy metal material, exampleSuch as platinumiridio or gold.
Further, catheter body 1 can be single layer structure, or multilayered structure.In order to improve catheter body 1Performance preferably sets multilayer mechanism for catheter body 1, and as shown in figs. 4 and 7, in the present embodiment, catheter body 1 is threeLayer structure comprising lubrication inner tube 12, support middle tube 13 and the outer tube 14 that successively nesting is arranged from inside to outside.Certainly existIn other embodiments, catheter body 1 also may include double-layer structure or more layers structure, be not particularly limited herein.
Specifically, lubrication inner tube 12 is using tubular structure made of the high molecular material with lubricating action.High scoreSub- material can have the material of low-friction coefficient using polytetrafluoroethylene (PTFE) (PTFE), fluorinated ethylene propylene copolymer (FEP) etc..Lubrication lumen is formed using the inner wall for lubricating inner tube 12 made of above-mentioned low friction coefficient materials, which has profitSliding effect, convenient for injecting its internal liquid flowing.
Support middle tube 13 is mainly used for supporting entire catheter body 1, to improve the structural strength of catheter body 1.SupportMiddle tube 13 is by using metal wire material, perhaps high molecular material is made and in the shape of a spiral or establishment type structure setting is in lubricationStructure between layer pipe 12 and outer tube 14.Further, spiral shell of the support middle tube 13 along the length direction of lubrication inner tube 12Rotation density or count may be the same or different.In the present embodiment, preferably different, so that catheter body 1 is differentPosition has different hardness.Further, spiral density or count of the support middle tube 13 close to doctor operating sideSpiral density or count of the middle tube 13 far from doctor operating side are preferably greater than supported, increase tendency can be for equablyIncrease, or unevenly increase, be not particularly limited herein.
Outer tube 14 is mainly used for fixed support middle tube 13, setting hardness adjustment hole 11 and the in-vivo tissue with patientContact.In the present embodiment, outer tube 14 is using tubular structure made of plastic type high molecular material.Plastic type macromolecule materialMaterial can be the plastic pipe such as nylon (PA or Pebax), polyvinyl chloride (PVC), silicon rubber, polypropylene (PP), polyethylene (PE)Material.Further, in order to enable catheter body 1 smoothly to move in patient vessel, when mitigating the importing blood vessel of catheter body 1Friction to vascular wall, to reduce damage of the conduit to vascular wall, as shown in Fig. 2, being arranged in the outside wall surface of outer tube 14There is hydrophilic lubrication coating 5.Hydrophilic lubrication coating 5 be using have hydrophilic properties, it is wettable, lubrication, be suitble to particular organismsLearn layer structure made of the material for interacting and being suitable for application in above medical instrument intervention class product.Hydrophilic lubrication coatingChemical action can occur between 5 and water to form a kind of gel rubber material, this gel rubber material can show extremely low frictionCoefficient has super greasy property.Still further, hydrophilic lubrication coating 5 can be single layer structure, or multilayered structure,Preferably multilayered structure, to improve greasy property.
In the present embodiment, hardness adjustment hole 11 is arranged in outer tube 14, by outer tube 14 close to doctor operating sideOne end extends along the other end of the axis direction outer layers pipe 14 of outer tube 14.Certainly in other embodiments, if conduit sheetBody 1 is more layers structure, and hardness adjustment hole 11 also can be set in outermost layer or middle layer.Optionally, hardness adjustment hole 11Quantity can be one, or it is multiple, it is in the present embodiment, as shown in figs. 4 and 7, preferably several.Multiple hardness tuneKnothole 11 is provided at circumferentially spaced along outer tube 14, is perfectly even distributed.By selecting different 11 grafting of hardness adjustment hole hardDegree, which adjusts body 2, can be changed catheter body 1 to the curved bending attribute of different directions, in order to which catheter body 1 is with goodBending attribute can be taken into account when hardness property, so that catheter body 1 is easy to tortuous and passed through pathological tissues.
Optionally, the cross sectional shape of multiple hardness adjustment holes 11 can be identical, as shown in Figure 4 and Figure 5, hardness adjustment hole 11Cross sectional shape be circle.Can certainly be different, as shown in 7 and Fig. 8, the cross sectional shape of some hardness adjustment holes 11 is circleShape, and the cross sectional shape of some hardness adjustment holes 11 is then trapezoidal.The hardness adjustment hole 11 of different cross section shape is preferably along conduitOntology 1 is provided at circumferentially spaced.Certainly in other embodiments, the shape of hardness adjustment hole 11 may be rectangle, parallel fourThe regular shapes such as side shape or ellipse or other profiled shapes.The preferred phase of cross sectional shape of each hardness adjustment hole 11 everywhereTogether, it is inserted into order to which hardness adjusts body 2.Accordingly, the shape that hardness adjusts body 2 is adapted with the shape of hardness adjustment hole 11.By the way that hardness adjustment hole 11 of different shapes is arranged, can grafting hardness of different shapes adjust body 2, hardness tune of different shapesThe bending force and hardness difference for saving body 2, can make catheter body 1 have different hardness property and bending attribute.Such as it is sameThe hardness of sectional area adjusts body 2, and rectangular and circular bending force is just different.
The depth of multiple hardness adjustment holes 11 may be the same or different.In the present embodiment, multiple hardness adjustment holes11 preferably differences, adjust body 2 with the hardness of grafting different length, so that reaching makes the hardness of 1 different parts of catheter body notSame purpose.The length of specific each hardness adjustment hole 11 is not particularly limited herein, as the case may be specific setting.
Further, it in order to improve the bending property of conduit, enables the duct to be changed according to patient vessel or lesion situationThe drug for the treatment of, suppository, bracket, spring ring etc. are transported to target lesion position, catheter body 1 provided in this embodimentOn be provided with flexible joint structure.As shown in Fig. 1, Fig. 3, Fig. 6 and Fig. 9, catheter body 1 includes two sections of straightways 101With one section of bending section 102, bending section 102 is above-mentioned flexible joint structure, by being made of easily deformable materialTubular structure.Bending section 102 is arranged between two sections of straightways 101, by be bent section 102 can make it is two neighboring straightLine segment 101 is parallel, that is, will wherein one section of straightway 101 is towards another 180 ° of 101 place lateral bend of straightway, to reachThe parallel effect of two straightways 101.And bending section 102 can make two sections of straightways 101 conllinear when keeping straight.Certainly existIn other embodiments, multiple flexible joint structures can also be set in catheter body 1.The master of flexible joint structureWanting function is so that conduit guarantees that the straightway 101 of catheter body 1 does not give a discount when tortuous, and eliminates extra support in bendingStress mitigates the recovery elastic force of conduit to make conduit compliance more preferable, enables the duct to readily and easily import tortuous blood vesselOr in access.
Further, catheter body 1 is operated for the ease of doctor, which further includes attachment base 3.Such as Fig. 1 and Fig. 2 instituteShow, attachment base 3 is female Luer attachment base, and one end of catheter body 1 is arranged in.Attachment base 3 includes sequentially connected firstInterconnecting piece 301, rotating part 303 and second connecting portion 302.It is provided in first connecting portion 301 and is connected to hardness adjustment hole 11It is inserted into hole 304, insertion hole 304 adjusts body 2 for being inserted into hardness.Body 2 is adjusted compared to hardness is axially inserted into along catheter body 1Insertion method, hardness adjust body 2 and bend into hardness adjustment hole 11 after the radial grafting of attachment base 3, not only more meet doctorOperating habit, exert a force convenient for doctor, and advantageously reduce the difficulty of alignment, be advantageously implemented hardness and adjust the quick slotting of body 2It connects and detaches.Rotating part 303 includes the blade that two panels is oppositely arranged, and doctor, which holds blade rotation, can be realized rotary guide pipe ontology1 purpose.Luer threads structure is provided in second connecting portion 302, the setting of luer threads structure is convenient for by the conduit and outsideThe equipment of portion's delivery conduit connects.
Further, in order to improve the bonding strength between attachment base 3 and catheter body 1, when avoiding conduit overbendingIt is broken between catheter body 1 and attachment base 3, which further includes protection pipe 4.As depicted in figs. 1 and 2, protection pipe 4 is arrangedBetween catheter body 1 and attachment base 3, protection pipe 4 is made of soft high molecular material, such as silicon rubber etc..Protection pipe 4On be provided with stress relief structure 401, specifically, as shown in Figure 10, stress relief structure 401 be arranged in protection pipe 4Groove structure, the setting of groove structure make the outer diameter of protection pipe 4 in grading structure, concentrate so as to eliminate in guiding-tube bendStress between catheter body 1 and attachment base 3, and then reaching prevents cracking between catheter body 1 and attachment base 3 from even fractureingPurpose.
The application method of the conduit of the adjustable hardness are as follows:
It needs first to do homework before starting interventional therapy, injecting apparatus is assembled on attachment base 3 by doctor first, soAfterwards in the intracavitary injection liquid of the lubrication management of catheter body 1.Then it is assessed, is chosen whether in catheter body according to preoperative caseFilling hardness adjusts body 2 in 1 hardness adjustment hole 11.Specifically, hardness tune can be filled not in hardness adjustment hole 11 in advanceBody 2 is saved, when catheter body 1 occurs adding hardness tune again when support force is inadequate during importing patient's body access or blood vesselSave body 2；Or can also be inserted into hardness in all hardness adjustment holes 11 in advance and adjust body 2, when catheter body 1 is importingDuring blood vessel or access when excessive high hardness, then detaches some or all of hardness and adjust body 2.
When starting interventional therapy, doctor is impregnated with medical use liquid first or is applied wet catheter surface, makes to be arranged in conduit sheetHydrophilic lubrication coating 5 on body 1 has lubricating action；Then doctor by puncture by this can hardness adjust and with flexibleThe conduit of joint structure imports human vas or access.During pushing conduit, if there is importing difficulty and causeEnter difficult reason be catheter body 1 support hardness not enough, conduit it is partially soft when, doctor can be to the insertion hole 304 of attachment base 3Interior insertion hardness adjusts body 2, and hardness adjusts body 2 and is plugged in hardness adjustment hole 11 from insertion hole 304, and is plugged to certain depthUntil conduit becomes that push importing blood vessel can be continued firmly enough.
It, at this time can outside extraction unit if finding the possibility of the too hard spinosity blood-breaking pipe of conduit or tissue in importing processDivide or whole hardness adjust body 2, reduces conduit hardness to reach, catheter body 1 is made to become the soft purpose complied with.ExtractionLength can need to control according to actual clinical, and the quantity of extraction can also need selected section or entire quantity to take out according to hardnessOut.
It, can be by control catheter body 1 if encountering 180 ° of blood vessel bendings during importing conduit in the blood vesselsThe position of flexible joint structure is realized, which is placed at the minimum dimension of vascular bending radius, in this wayPrevent conduit from giving a discount can adapt to curved blood vessel again simultaneously.
The present embodiment additionally provides a kind of intervention device, which includes the conduit of above-mentioned adjustable hardness.Pass throughUsing above-mentioned conduit, which can fast and efficiently complete interventional therapy, be conducive to improve interventional therapy efficiency withAnd the post-operative recovery effect of patient.
Obviously, the above embodiment of the present invention is just for the sake of clearly illustrating examples made by the present invention, and being not is pairThe restriction of embodiments of the present invention.For those of ordinary skill in the art, may be used also on the basis of the above descriptionTo make other variations or changes in different ways.There is no necessity and possibility to exhaust all the enbodiments.It is all thisMade any modifications, equivalent replacements, and improvements etc., should be included in the claims in the present invention within the spirit and principle of inventionProtection scope within.