CN110448360A - A kind of multifunctional heart interval tubulose sting device and preparation method thereof and application - Google Patents
A kind of multifunctional heart interval tubulose sting device and preparation method thereof and application Download PDFInfo
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- CN110448360A CN110448360A CN201910762440.3A CN201910762440A CN110448360A CN 110448360 A CN110448360 A CN 110448360A CN 201910762440 A CN201910762440 A CN 201910762440A CN 110448360 A CN110448360 A CN 110448360A
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- 238000005452 bending Methods 0.000 claims abstract description 91
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- 229910052751 metal Inorganic materials 0.000 claims abstract description 35
- 239000002184 metal Substances 0.000 claims abstract description 35
- 230000001012 protector Effects 0.000 claims abstract description 30
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims abstract description 22
- KHYBPSFKEHXSLX-UHFFFAOYSA-N iminotitanium Chemical compound [Ti]=N KHYBPSFKEHXSLX-UHFFFAOYSA-N 0.000 claims abstract description 19
- 210000003157 atrial septum Anatomy 0.000 claims abstract description 16
- 210000005240 left ventricle Anatomy 0.000 claims abstract description 12
- 210000002837 heart atrium Anatomy 0.000 claims abstract description 11
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- 229910052742 iron Inorganic materials 0.000 claims description 3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C14/00—Alloys based on titanium
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- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C19/00—Alloys based on nickel or cobalt
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C30/00—Alloys containing less than 50% by weight of each constituent
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
- C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
- C22F1/10—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of nickel or cobalt or alloys based thereon
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
- C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
- C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
- C22F1/18—High-melting or refractory metals or alloys based thereon
- C22F1/183—High-melting or refractory metals or alloys based thereon of titanium or alloys based thereon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
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- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B2017/3454—Details of tips
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Abstract
The present invention provides a kind of multifunctional heart interval tubulose sting devices and preparation method thereof and application, the multifunctional heart interval tubulose sting device includes tubulose puncture needle, the tubulose puncture needle is made of Ni-Ti-based shape memory alloy, it includes needle body and needle point, the needle body is hollow tubular structure, presets the bending part of certain bending angle in needle body certain close to needle point；Metal protection protector, the part needle body and needle point sleeve close to needle point are loaded in the metal protection protector；Direction instruction mark is installed on the tail portion of the tubulose puncture needle needle body, for determining the curved direction of needle point；After tubulose puncture needle enters the chambers of the heart, close to needle body certain of needle point it is heated after, hardness increase and can automatic bending to the bending angle.It is able to achieve safely and effectively to enter atrium dextrum puncture atrial septum through inferior caval vein or enter left ventricle through peripheral arterial using the device and punctures interventricular septum, and the positioning of chambers of the heart radiography and the monitoring of chambers of the heart internal pressure can also be assisted by the present apparatus.
Description
Technical field
The present invention relates to a kind of multifunctional heart interval tubulose sting devices and preparation method thereof and application, belong to Medical treatment device
Tool technical field.
Background technique
Heart atrial septal puncture background:
It is one of clinical common technology through conduit heart atrial septal puncture, enters the progress of the left heart to feel concerned about system through vein-right side
Interventional therapy provides effective operation pathway, is the indispensable method of numerous heart interventional therapy formulas, such as through conduit auricular fibrillation
Radio-frequency ablation procedure, through conduit Percutaneous Balloon Mitral Commissurotomy, through conduit atrium sinistrum ear percutaneous transcatheter closure, through conduit atrial septostomy etc..
Current clinically used sting device is mainly Brockenbrough Interaurcular septum puncture needle and matched Mullins puncture sheath system
It unites (St Jude Medical Inc).Other rare sting devices include the devices such as atrial septum RF ablation puncture needle.It is above-mentioned
These atrial septal puncture special equipments can satisfy most of clinical demand, however some cardiac anatomies are substantially change
Patient's then Shortcomings, including merge the swollen exoncoma in atrial septum, giant right atrium, atrial septum position are postoperative etc..In addition, based on puncturing
The physical characteristic of needle and percutaneously through the limitation of catheter path, the puncture angle of above-mentioned lancing system is also significantly limited, it is difficult to reach
It is bordering on vertical puncture angle, wherein clinical most common Brockenbrough puncture needle hardness is big and is difficult to be bent, usually tiltedly
Row punctures atrial septum.Therefore a kind of completely new atrial septal puncture needle system is clinically needed to solve these problems.
Cardiac septum punctures background:
Puncturing cardiac septum through conduit clinically has huge demand, can feel concerned about system into a left side to feel concerned about system through the right side
Easy access is provided.Although in recent years, thering are different puncture instruments and method to be suggested, by the limit of material and methodology
System there is no safe and reliable instrument and method that can put it over application in clinic so far.Therefore, one kind is clinically needed at present
Completely new cardiac septum puncture instrument and method solve this problem.
At present it has been reported that through conduit puncture cardiac septum instrument and method mainly include the following three types: [1] from
Superior vena cava approach enters right ventricle using atrial septum Brockenbrough puncture needle (St Jude Medical Inc) and punctures room
Interval；[2] from superior vena cava approach, atrial septum RF ablation puncture needle (Radiofrequency transseptal is used
Needle, NRG；Bayliss Medical, Montreal, Canada) enter right ventricle's puncture interventricular septum；[3] through superior vena cava way
Diameter, using the wire guide being connected with the diathermanous pen of RF energy (Diathermy pen radiofrequency energy) into
Enter right ventricle and punctures interventricular septum.There is significant deficiency in above-mentioned three kinds of instruments and method, cause clinically to be difficult to promote and apply.One,
Above-mentioned three kinds of methods must enter right ventricle through superior vena cava approach and puncture interventricular septum, position and wear when this causes to puncture interventricular septum
Direction is pierced to be difficult to control；Two, Brockenbrough puncture needle is metal hollow needle, and hardness is big and is difficult to be bent, and punctures right ventricular
The position at interval and differential seat angle；Though three, puncturing the RF ablation puncture needle of atrial septum or connecting the seal wire of the diathermanous pen of RF energy
The angle of puncture is so improved, but RF ablation brings the irreversibility collateral damage of site of puncture and surrounding, prognosis at a specified future date is still
It is unclear.In order to solve the problems, such as that presently, there are need to develop a kind of new method and puncture needle dress into left ventricle path
It sets.
Summary of the invention
In order to solve the above shortcomings and deficiencies, the purpose of the present invention is to provide a kind of multifunctional heart interval tubuloses to wear
Pricker and preparation method thereof and application.Peace can be realized using the multifunctional heart interval tubulose puncture needle provided by the present invention
Effectively enter atrium dextrum puncture atrial septum through inferior caval vein entirely or enter left ventricle through peripheral arterial and puncture interventricular septum, and leads to
The positioning of chambers of the heart radiography and the monitoring of chambers of the heart internal pressure can also be assisted by crossing the present apparatus.Therefore, which, which is that one kind is completely new, has
Effect punctures the instrument of atrial septum and interventricular septum, provides a safe and reliable path for subsequent interventional therapy.
In order to achieve the goal above, on the one hand, the present invention provides a kind of multifunctional heart interval tubulose sting device,
In, the multifunctional heart interval tubulose sting device includes:
Tubulose puncture needle, the tubulose puncture needle are made of Ni-Ti-based shape memory alloy comprising needle body and needle point, it should
Needle body is hollow tubular structure, presets the bending part of certain bending angle in needle body certain close to needle point；
Metal protection protector, the part needle body and needle point sleeve close to needle point are loaded in the metal protection protector；
Direction instruction mark is installed on the tail portion of the tubulose puncture needle needle body, for determining the curved direction of the needle point；
After the tubulose puncture needle enters the chambers of the heart, after needle body certain of close needle point is heated, hardness increases and energy
Automatic bending is to the bending angle, in order to puncture cardiac septum.
Specific embodiment according to the present invention presets one in needle body certain close to needle point in the device
The bending part for determining bending angle, is thus apparent from, which includes the needle body of needle point and part close to needle point；
In addition, the length of the part needle body for the close needle point being set in the metal protection protector should be greater than being bent in the present invention
The length of needle body included by part.
Specific embodiment according to the present invention, in the device, it is preferable that the bending angle is 30-90 °, more
Preferably, the bending angle is 45-60 °.
Specific embodiment according to the present invention, in the device, it is preferable that the length of the bending part is 0.5-
6cm, it is highly preferred that the length of the bending part is 1-3cm, it is further preferred that the length of the bending part is 2-
3cm。
Specific embodiment according to the present invention, it is preferable that described device further includes stop,threeway, the stop,threeway with it is described
The tail portion of tubulose puncture needle needle body is cooperatively connected.
Specific embodiment according to the present invention, in the device, it is preferable that the material of the stop,threeway is modeling
Material.
Specific embodiment according to the present invention, in the device, it is preferable that the direction instruction target material is also
Plastics.
Specific embodiment according to the present invention, it is preferable that be provided with length scale on the needle body, which rises
Beginning scale is located at needle body tail portion.Wherein, the present invention can show needle body in being provided with length scale mark on needle body when in use
The length of human body is entered.
Wherein, the purpose of the present invention device setting direction indicateing arm (tail portion marker) is to determine that needle point is curved
Direction, for determine tubulose puncture needle bending direction (in surgical procedure, by imaging device real time imagery, it can be observed that
The bending direction at needle point position), it is convenient for controlling and adjusting direction and position of the tubulose puncture needle in atrium dextrum or left ventricle
It sets；
The purpose that stop,threeway is arranged is to survey pressure for the ease of the chambers of the heart and positioned by puncture needle hand push contrast agent.
Specific embodiment according to the present invention, in the device, it is preferable that in tubulose puncture needle local environment temperature
Lower than the martensitic transformation temperature range of Ni-Ti-based shape memory alloy ceiling temperature when, it is described to be closed by Ni-Ti-based shape memory
In tubulose puncture needle made of gold, soft condition is presented in at least described bending part, easily deformable；The ring locating for tubulose puncture needle
It is described by NiTi base shape when border temperature is higher than the lower limit temperature of the austenite transition temperature range of Ni-Ti-based shape memory alloy
In tubulose puncture needle made of memorial alloy, the hardness of at least described bending part increases, and the bending part can automatic bending
To the bending angle；
Wherein, the martensitic transformation temperature range of Ni-Ti-based shape memory alloy is 0-30 DEG C, austenite transition temperature
Range is 15-35 DEG C.
In the present invention, the environment temperature locating for tubulose puncture needle is upper lower than the martensitic transformation temperature range of its alloy
When limiting temperature, soft condition is presented in crystal structure B19 ' phase or B19 phase or R phase, at least described bending part, and elasticity modulus is
20-60GPa, it is easily deformable；When its local environment temperature is higher than the lower limit temperature of the austenite transition temperature range of its alloy,
Crystal structure transition is B2 phase, and hardness increases, elasticity modulus 50-100GPa, and the hardness of at least described bending part increases, and
The bending part can automatic bending to the bending angle.Specifically, martensitic transformation temperature range and austenite transition temperature
Range is different due to the difference of tubulose puncture needle alloying component.
Specific embodiment according to the present invention, in the device, it is preferable that the Ni-Ti-based shape memory alloy packet
Include NiTi alloy or NiTi-X alloy；Wherein, X is the combination selected from one of Nb, Cu, Fe and Ag element or multiple element；
It is highly preferred that the atomic ratio of Ni is 48-52at%, remaining is Ti in NiTi alloy；
It is more preferred still that the atomic ratio of Ti element and Ni element is 0.8:1.1-1.2:0.9, X element in NiTi-X alloy
Atomic percentage less than 20%.
Specific embodiment according to the present invention, in the device, it is preferable that the cross section of the needle body includes annulus
Or polygon ring；
It is highly preferred that the outer diameter of the cross section of the needle body or the diagonal line length across the cross-section center are 0.2-3mm,
Internal diameter is 0.1-2.5mm across the diagonal line length of the cross-section center；
It is further preferred that the cross section of the needle body is annulus, the outer diameter of the annulus is 1-3mm, internal diameter 0.5-
2mm。
Specific embodiment according to the present invention, in the device, it is preferable that the oblique section of the needle point is elliptical ring
The angle of shape, the oblique section and needle body is 10-60 °；
It is highly preferred that the angle of the oblique section and needle body is 30-45 °.
Specific embodiment according to the present invention, in the device, it is preferable that the metal protection protector is hollow tube,
Its outer diameter is 2-4mm, and internal diameter is identical as the needle body outer diameter, and the tail end of the metal protection protector (deviates from metal protection protector opening side
To one end be tail end) be it is round table-like, material includes stainless steel, aluminium, copper；
It is highly preferred that the metal protection protector is the round tube of stainless steel material, outer diameter 2-3mm, the internal diameter of inner cavity
For 1-2mm.
Wherein, the metal protection protector is for protecting needle point and can assist and (be convenient for) that tubulose puncture needle is sent into sheath.
Specific embodiment according to the present invention, in the device, the length of the tubulose puncture needle can basis
Particular condition in use is configured, it is preferable that the length of the tubulose puncture needle is 80-130cm.
On the other hand, the present invention also provides the production method of the multifunctional heart interval tubulose sting device,
In, the production method the following steps are included:
(1) nickel titanium-base shape memory alloy tubing is chosen, and makes needle point in one end of the tubing；
(2) tubing for having produced needle point to step (1) carries out shaping processing, and the needle body end will be close to needle point is preset out
Bending part with certain bending angle；
(3) ageing treatment is carried out to gained tubing after step (2) setting treatment or to the bending part；
(4) the part needle body and needle point sleeve that will be close to needle point again are loaded in metal protection protector, and direction instruction mark is installed
In the tail portion of the tubulose puncture needle needle body to get arrive the multifunctional heart interval tubulose sting device.
Specific embodiment according to the present invention, in the production method, it is preferable that added in step (1) using mechanical
Work grinds needle point or makes needle point using etch.
Specific embodiment according to the present invention, in the production method, it is preferable that in step (2), at the sizing
Managing temperature is 350-650 DEG C, and the setting treatment time is 180-2 minutes；It is highly preferred that the setting treatment temperature is 400-650
DEG C, it is further preferred that the setting treatment temperature is 450-600 DEG C.Under normal circumstances, needed for setting temperature is higher when sizing
Between it is shorter.
Specific embodiment according to the present invention, in the production method step (2), the purpose of the setting treatment is
In order to formulate the shape of tubulose puncture needle, which can be followed the steps below:
Install the tubing that step (1) has produced needle point additional shaping equipment (conventional equipment that this field uses), wherein curved
The shaping equipment of bent portions is the flexure type shaping equipment with specific curvature angle, shaping equipment used except bending part
For linear type shaping equipment.
Specific embodiment according to the present invention, in the production method, it is preferable that in step (3), at the timeliness
The temperature of reason is not higher than the setting treatment temperature, and the aging time is 360-5 minutes；It is highly preferred that the timeliness
The temperature of processing is 0-200 DEG C lower than setting treatment temperature；It is further preferred that the temperature of the ageing treatment is 300-600 DEG C.
Specific embodiment according to the present invention, in the production method step (3), the purpose of the ageing treatment is
In order to adjust the phase transition temperature (martensitic phase including the austenite transition temperature that changes software strategy into software-hardware strategy and from hard to soft of tubulose puncture needle
Temperature), which includes two ways: a kind of mode is for the whole (institute after setting treatment of tubulose puncture needle
Obtain tubing) ageing treatment is carried out, aging temperature is 300-600 DEG C, and (aging temperature generally selected slightly below is formed
Temperature, as the temperature of ageing treatment is 0-200 DEG C lower than setting treatment temperature), preferably 300-550 DEG C, more preferably 400-500
DEG C, aging time is 360-5 minutes, preferably 180-10 minutes；The tubulose puncture needle that this kind of processing mode obtains is low
Temperature is lower whole be all it is soft, into human body after be integrally hardened, tip portion automatic bending to set angle；Another way is
Only to tubulose puncture needle close to one end of needle point, including tubulose puncture needle bending part (needle point and part needle body) and another part
Needle body, about 2-30cm carries out ageing treatment altogether, and aging temp is 300-600 DEG C, preferably 300-550 DEG C, more preferably 400-
500 DEG C, aging time is 360-5 minute, the tubulose puncture needle of this kind of processing method acquisition needle point one end at low temperature
Bending part be it is soft, most of hardness of needle body is higher, and into after human body, needle body firmness change is little, needle point one end from
It is dynamic to be bent to set angle, and hardness is promoted.
In production method of the present invention, two step of setting treatment and ageing treatment has successively been carried out to tubulose puncture needle
Sizing is separated with phase transition temperature regulation and is successively carried out by processing, and aging temperature is generally not more than setting treatment temperature,
Preferably, aging temperature is 0-200 DEG C lower than setting treatment temperature, and the setting treatment time is shorter, and aging time is longer；
It can also be better achieved while more preferably, more accurately realizing the shape sizing of tubulose puncture needle to phase transition temperature in this way
It is adjusted.
Specific embodiment according to the present invention, the production method further include producing to gained after step (3) ageing treatment
After product carry out surface cleaning processing, wherein the surface cleaning processing is to surface progress pickling cleaning treatment.
Specific embodiment according to the present invention, it is preferable that the production method further include: direction instruction mark is installed on the pipe
Behind the tail portion of shape puncture needle needle body, then by the tail portion of stop,threeway and the tubulose puncture needle needle body be cooperatively connected to get
To the multifunctional heart interval tubulose sting device.
Another aspect, the present invention also provides the multifunctional heart interval tubulose sting devices to be used as through cavity of resorption
Vein enters atrium dextrum and punctures atrial septum or enter the application that left ventricle punctures the sting device of interventricular septum through peripheral arterial.
Specific embodiment according to the present invention, in the application, it is preferable that, will be locating for tubulose puncture needle before application
After environment temperature is set below the ceiling temperature of martensitic transformation temperature range of Ni-Ti-based shape memory alloy, to the tubulose
Puncture needle carries out artificial aligning and is punctured again.
It wherein, can be lower than Ni-Ti-based shape memory alloy by tubulose puncture needle local environment temperature setting before
The ceiling temperature (the tubulose puncture needle can be such as placed in mixture of ice and water) of martensitic transformation temperature range, the tubulose puncture needle
In B19 ' phase or B19 phase or R phase, soft condition is presented, it is easily deformable, the tubulose puncture needle can manually be rectified at this time
Directly；After tubulose puncture needle enters heart, temperature is more than 30 DEG C in heart, is higher than the austenite phase of Ni-Ti-based shape memory alloy
The lower limit temperature of temperature range, needle point position is by temperature action automatic bending to preset bending angle, crystal structure transition
For B2 phase, hardness increases；
In addition, soft condition is presented when tubulose puncture needle is placed in external mixture of ice and water, and it is easily deformable, convenient for its warp
Peripheral arterial enters left ventricle, and needle point position automatic bending is to presetting angle and hard after tubulose puncture needle enters left ventricle
Degree dramatically increases.
In application process, it can also assist realizing the function of radiography positioning and monitoring endocardial pressure by hollow lumen
Energy.
Tubulose puncture needle in the device provided by the present invention it is dynamic can be primarily but not limited to stock by peripheral arterial
Arteries and veins is completed interventricular septum and is punctured；It can also be primarily but not limited to femoral vein by peripheral vein, complete atrial septal puncture, avoid
Drawback present in art methods.
The multifunctional heart interval tubulose sting device provided by the present invention has the deformation under special temperature control
With adjoint stiffness changing feature (can body temperature voluntarily change hardness and bending angle), it can be punctured for cardiac septum and pole is provided
Good needle angle, efficiently accomplishes heart atrial septum and interventricular septum punctures task；Tubulose in device provided by the present invention punctures
Needle distal predetermined angle multiplicity can complete different atrial septum and interventricular septum and puncture task；The tubulose puncture needle passes through hollow
Lumen can also assist realizing the function of radiography positioning and monitoring endocardial pressure.Moreover, it relates to the tubulose wear
Pricker is to be punctured by physical method, small to interventricular septum and puncture surrounding tissue collateral damage, and bring potential hazard is big
Width reduces, and needle body is tiny, and operational safety is better than art methods, and can repeatedly attempt cardiac septum puncture.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, embodiment will be described below
Needed in attached drawing be briefly described, it should be apparent that, the accompanying drawings in the following description is some implementations of the invention
Example, for those of ordinary skill in the art, without creative efforts, can also obtain according to these attached drawings
Obtain other attached drawings.
Fig. 1 is the structural schematic diagram of the multifunctional heart interval tubulose sting device provided by the present invention.
Fig. 2 is to preset camber schematic diagram after the heating of tubulose puncture needle in the specific embodiment of the invention.
Main Reference label declaration:
1, direction instruction mark；
2, tubulose puncture needle；
3, metal protection protector；
4, stop,threeway.
Specific embodiment
In order to which technical characteristic of the invention, purpose and beneficial effect are more clearly understood, now in conjunction in detail below
Embodiment carries out following detailed description to technical solution of the present invention, but should not be understood as the limit to enforceable range of the invention
It is fixed.
Fig. 1 is the structural schematic diagram of the multifunctional heart interval tubulose sting device provided by the present invention, such as Fig. 1 institute
Show, which includes:
Tubulose puncture needle 2, the tubulose puncture needle 2 are made of Ni-Ti-based shape memory alloy comprising needle body and needle point,
The needle body is hollow tubular structure, presets the bending part of certain bending angle in needle body certain close to needle point；
Metal protection protector 3, the part needle body and needle point sleeve close to needle point are loaded in the metal protection protector；Metal protection protector 3
For protecting needle point and assisting tubulose puncture needle 2 being sent into sheath；
Direction instruction mark 1, is installed on the tail portion of the tubulose puncture needle needle body, it is exposed in vitro, for determining when use
The curved direction of needle point is convenient for controlling and adjusting direction and position of the tubulose puncture needle in atrium dextrum or left ventricle
It sets；
After the tubulose puncture needle enters the chambers of the heart, after needle body certain of close needle point is heated, hardness increases and energy
Automatic bending is to the bending angle, in order to puncture cardiac septum.
In one embodiment, the bending angle is 30-90 °.
In one embodiment, the length of the bending part is 0.5-6cm.
In one embodiment, described device further includes stop,threeway, and the material of the stop,threeway is plastics.
In one embodiment, the direction instruction target material is also plastics.
In one embodiment, the Ni-Ti-based shape memory alloy includes NiTi alloy or NiTi-X alloy；Wherein, X is
Combination selected from one of Nb, Cu, Fe and Ag element or multiple element；
In NiTi alloy, the atomic ratio of Ni is 48-52at%, remaining is Ti；
In NiTi-X alloy, the atomic ratio of Ti element and Ni element is 0.8:1.1-1.2:0.9, the atomic percent of X element
Number is less than 20%.
Because of ingredient difference, phase transition temperature is also different for NiTi alloy or NiTi-X alloy；NiTi alloy or NiTi-X alloy
Martensitic transformation temperature be 0-30 DEG C, when the tubulose puncture needle local environment temperature be 0-30 DEG C within the scope of any temperature when,
Tubulose puncture needle softens；When its local environment temperature is warming up to any temperature within the scope of 20-35 DEG C, austenite phase transformation, pipe occurs
Shape puncture needle is hardened, and needle point position is bent to predetermined angle.When such as tubulose puncture needle 2, temperature is lower than 20 DEG C in vitro, crystal
Structure is B19 ' phase or B19 phase or R phase, and soft condition is presented, easily deformable；After tubulose puncture needle enters heart, needle tip
For automatic bending to preset bending angle, crystal structure transition is B2 phase after position is heated, and hardness increases.
In one embodiment, the cross section of the needle body includes annulus or polygon ring；The outer diameter of the cross section of the needle body
Or across the cross-section center diagonal line length be 0.2-3mm, internal diameter or the diagonal line length across the cross-section center are
0.1-2.5mm。
In one embodiment, the oblique section of the needle point is oval ring, and the angle of the oblique section and needle body is 10-60 °.
In one embodiment, the metal protection protector is hollow tube, outer diameter 2-4mm, internal diameter and the needle body outer diameter
It is identical, the tail end of the metal protection protector be it is round table-like, material includes stainless steel, aluminium, copper.
In one embodiment, the length of the tubulose puncture needle is 80-130cm.
In one embodiment, it is provided with length scale on the needle body, the start index of the length scale is located at needle body tail
Portion.
In one embodiment, described device further includes stop,threeway 4, the stop,threeway 4 and 2 needle body of tubulose puncture needle
Tail portion be cooperatively connected.
The production method of the multifunctional heart interval tubulose sting device provided by the present invention the following steps are included:
(1) nickel titanium-base shape memory alloy tubing is chosen, and makes needle point in one end of the tubing；
(2) tubing for having produced needle point to step (1) carries out shaping processing, is precast with will be close to the needle body end of needle point
Bending part with certain bending angle；
(3) ageing treatment is carried out to gained tubing after step (2) setting treatment or to the bending part；
It is further preferred that the temperature of the ageing treatment is not higher than the setting treatment temperature, the aging time is
360-5 minutes；It is more preferred still that the temperature of the ageing treatment is 0-200 DEG C lower than setting treatment temperature；Still further preferably
Ground, the temperature of the ageing treatment are 300-600 DEG C；
(4) the part needle body and needle point sleeve that will be close to needle point are loaded in metal protection protector, and direction instruction mark is installed on
The tail portion of the tubulose puncture needle needle body, then the tail portion of stop,threeway and the tubulose puncture needle needle body is cooperatively connected, i.e.,
Obtain the multifunctional heart interval tubulose sting device.
In one embodiment, machining can be used in step (1) to grind needle point or make needle point using etch.
In one embodiment, in step (2), the purpose of the setting treatment is the shape in order to formulate tubulose puncture needle,
The setting treatment can follow the steps below:
Install the tubing that step (1) has produced needle point additional shaping equipment (conventional equipment that this field uses), wherein curved
The shaping equipment of bent portions is the flexure type shaping equipment with specific curvature angle, shaping equipment used except bending part
For linear type shaping equipment；
The setting treatment temperature is 350-650 DEG C, and the setting treatment time is 180-2 minutes；Tubulose is worn after setting treatment
Pricker shape is as shown in Figure 2.
In one embodiment, in step (3), the purpose of the ageing treatment is the phase alternating temperature in order to adjust tubulose puncture needle
Degree (martensitic transformation temperature including the austenite transition temperature that changes software strategy into software-hardware strategy and from hard to soft), which includes
Two ways: a kind of mode is that ageing treatment is carried out for tubulose puncture needle whole (gained tubing after setting treatment), at timeliness
Managing temperature is 300-600 DEG C, and aging time is 360-5 minutes；The tubulose puncture needle that this kind of processing mode obtains is in low temperature
Lower entirety be all it is soft, into human body after be integrally hardened, tip portion automatic bending to set angle；Another way is only
To tubulose puncture needle close to one end of needle point, including tubulose puncture needle bending part (needle point and part needle body) and another part needle
Body (length of bending part and another part needle body is total to about 2-30cm) carries out ageing treatment, aging temperature 300-600
DEG C, aging time is 360-5 minutes, and aging temperature is generally slightly below setting treatment temperature, this kind of processing method obtains
Tubulose puncture needle needle point one end at low temperature bending part be it is soft, most of hardness of needle body is higher, into people
After body, needle body firmness change is little, needle point one end automatic bending to set angle, and hardness is promoted.
In one embodiment, this method further includes carrying out surface acid-washing cleaning to products obtained therefrom after step (3) ageing treatment
Processing.
Some specific embodiments are given below, illustrate the multifunctional heart interval tubulose sting device provided by the present invention
And preparation method thereof with application.
Embodiment 1
Present embodiments provide a kind of multifunctional heart interval tubulose sting device, wherein the multifunctional heart spacer tube
Shape sting device includes:
Tubulose puncture needle, by NiTi, (atomic ratio of Ti is 51at% to the tubulose puncture needle, and the atomic ratio of Ni is
49at%) alloy is made comprising needle body and needle point, the needle body are that (outer diameter 1.2mm, internal diameter are hollow circular tubular structure
0.8mm), 60 ° of bending part (length 2cm) is preset in needle body certain close to needle point, wherein the bending section subpackage
Include needle point (the length is 0.5cm) and a part of needle body；
The oblique section of the needle point is oval ring, and the angle of the oblique section and needle body is 30 °；
Metal protection protector, the part needle body and needle point sleeve close to needle point are loaded in the metal protection protector；The metal coating
Set is the hollow circular tube of stainless steel material, and outer diameter 3mm, internal diameter is identical as the needle body outer diameter, is 1.2mm, which protects
The tail end of sheath is round table-like；
Direction instruction mark can dismantle the tail portion for being assembled in tubulose puncture needle needle body, be plastic material, it is exposed to when use
In vitro, for determining the curved direction of the needle point, it is convenient for controlling and adjusting tubulose puncture needle in atrium dextrum or left ventricle
Interior direction and position；
The tail portion of stop,threeway, the stop,threeway and the tubulose puncture needle needle body is cooperatively connected；
The martensitic transformation temperature of NiTi alloy used in the present embodiment is 0-30 DEG C, when the tubulose puncture needle local environment
When temperature is any temperature within the scope of 0-30 DEG C, tubulose puncture needle needle point position softens；Its local environment temperature is warming up to 15-35
Within the scope of DEG C when any temperature, austenite phase transformation occurs, tubulose puncture needle needle point position is hardened, and needle point position is bent to default
Angle (i.e. 60 °).
The production method of the multifunctional heart interval tubulose sting device provided by the present embodiment the following steps are included:
Production material is the tubulose puncture needle of NiTi (Ti-51at%Ni) alloy:
(1) NiTi tubing is chosen, is outer diameter 1.2mm, the circular pipe of internal diameter 0.8mm intercepts the tubing of appropriate length；
(2) needle point (length of needlepoint 0.5cm) that machining oblique section and needle body angle are 30 °；
(3) tubing for having produced needle point to step (2) carries out shaping processing, is precast with will be close to the needle body end of needle point
Bending part with certain bending angle, specifically: install the tubing that step (2) has produced needle point additional shaping equipment (this
The conventional equipment that field uses), wherein the shaping equipment of bending part is the flexure type shaping equipment with 60 ° of bending angle,
Shaping equipment used is linear type shaping equipment except bending part；Tubulose puncture needle is then placed in setting treatment furnace to carry out
Processing, setting temperature are 500 DEG C, and setting time is 10 minutes；
To tubulose puncture needle close to one end of needle point, including it is tubulose puncture needle bending part (needle point and part needle body) and another
A part of needle body (length of bending part and another part needle body is total to about 2-30cm) carries out ageing treatment, the temperature of ageing treatment
It is 450 DEG C, aging time is 30 minutes；
(4) products obtained therefrom carries out surface acid-washing cleaning treatment after step (3) ageing treatment, and obtaining material is NiTi (Ti-
51at%Ni) the tubulose puncture needle of alloy；
When the prepared tubulose puncture needle of the present embodiment is placed in mixture of ice and water, soft condition is presented in needle point, into
Row alignment, then simulates temperature in heart, tubulose puncture needle is placed in about 35 DEG C of warm water, and the heated automatic bending of needle point becomes pre-
It is arranged angle (60 °), and needle point hardness increases.
The part needle body and needle point sleeve that will be close to needle point are loaded in metal protection protector, and direction instruction mark is installed on the pipe
The tail portion of shape puncture needle needle body, then the tail portion of stop,threeway and the tubulose puncture needle needle body is cooperatively connected to get arriving
The multifunctional heart interval tubulose sting device.
Embodiment 2
Present embodiments provide a kind of multifunctional heart interval tubulose sting device, wherein the multifunctional heart spacer tube
Shape sting device includes:
Tubulose puncture needle, by NiTiNb alloy, (atomic ratio of Ti, Ni element is 0.9:1, Nb element to the tubulose puncture needle
Atomic percentage be 10%) be made comprising needle body and needle point, the needle body be hollow circular tubular structure (outer diameter 1mm,
Internal diameter is 0.6mm), 50 ° of bending part (length 2cm) is preset in needle body certain close to needle point, wherein the bending
Part includes needle point (the length is 0.3cm) and a part of needle body；
The oblique section of the needle point is oval ring, and the angle of the oblique section and needle body is 20 °；
Metal protection protector, the part needle body and needle point sleeve close to needle point are loaded in the metal protection protector；The metal coating
Set is the hollow circular tube of stainless steel material, and outer diameter 3mm, internal diameter is identical as the needle body outer diameter, is 1cm, the metal coating
The tail end of set is round table-like；
Direction instruction mark can dismantle the tail portion for being assembled in tubulose puncture needle needle body, be plastic material, it is exposed to when use
In vitro, for determining the curved direction of the needle point, it is convenient for controlling and adjusting tubulose puncture needle in atrium dextrum or left ventricle
Interior direction and position；
The tail portion of stop,threeway, the stop,threeway and the tubulose puncture needle needle body is cooperatively connected；
The martensitic transformation temperature of NiTi alloy used in the present embodiment is 0-30 DEG C, when the tubulose puncture needle local environment
When temperature is any temperature within the scope of 0-30 DEG C, tubulose puncture needle softens；Its local environment temperature is warming up within the scope of 15-35 DEG C
When any temperature, austenite phase transformation occurs, tubulose puncture needle is hardened, and needle point position is bent to predetermined angle (i.e. 60 °).
The production method of the multifunctional heart interval tubulose sting device provided by the present embodiment the following steps are included:
Making material is that (atomic ratio of Ti, Ni element is 0.9:1 to NiTiNb alloy, and the atomic percentage of Nb element is
10%) tubulose puncture needle:
(1) NiTiNb alloy pipe is chosen, is outer diameter 1mm, the circular pipe of internal diameter 0.6mm intercepts appropriate length
Tubing；
(2) needle point (length of needlepoint 0.3cm) that machining oblique section and needle body angle are 20 °；
(3) tubing for having produced needle point to step (2) carries out shaping processing, is precast with will be close to the needle body end of needle point
Bending part with certain bending angle, specifically: install the tubing that step (2) has produced needle point additional shaping equipment (this
The conventional equipment that field uses), wherein the shaping equipment of bending part is the flexure type shaping equipment with 50 ° of bending angle,
Shaping equipment used is linear type shaping equipment except bending part；Tubulose puncture needle is then placed in setting treatment furnace to carry out
Processing, setting temperature are 530 DEG C, and setting time is 15 minutes；
To tubulose puncture needle close to one end of needle point, including it is tubulose puncture needle bending part (needle point and part needle body) and another
A part of needle body (length of bending part and another part needle body is total to about 2-30cm) carries out ageing treatment, and aging temperature is
400 DEG C, aging time is 60 minutes；
(4) products obtained therefrom carries out surface acid-washing cleaning treatment after step (3) ageing treatment, and obtaining material is NiTi (Ti-
51at%Ni) the tubulose puncture needle of alloy；
When the prepared tubulose puncture needle of the present embodiment is placed in mixture of ice and water, soft condition is presented in needle point, into
Row alignment, then simulates temperature in heart, tubulose puncture needle is placed in about 35 DEG C of warm water, and the heated automatic bending of needle point becomes pre-
It is arranged angle (50 °), and needle point hardness increases.
The part needle body and needle point sleeve that will be close to needle point are loaded in metal protection protector, and direction instruction mark is installed on the pipe
The tail portion of shape puncture needle needle body, then the tail portion of stop,threeway and the tubulose puncture needle needle body is cooperatively connected to get arriving
The multifunctional heart interval tubulose sting device.
When using the multifunctional heart interval tubulose sting device provided by the present invention, first by tubulose puncture needle needle point
It is placed in the environment of the external ceiling temperature lower than Ni-Ti-based shape memory alloy martensitic transformation temperature, is such as lower than 20 DEG C of environment
Under, tubulose puncture needle needle point position is manually aligned；It assists for tubulose puncture needle feeding being placed in by metal protection protector again
Peripheral arterial or inferior caval vein conduit, across the hollow cavity of conduit, tubulose puncture needle enters trouble under conduit guiding function
Person atrium dextrum or left ventricle, tubulose puncture needle is influenced automatic bending to default by human body temperature (i.e. temperature be higher than 30 DEG C when) at this time
Angle setting degree, i.e. 30-90 ° of bending angle range, bending part length range 0.5-6cm；Operation tubular puncture needle rear-mounted installation again
Direction and the position of adjustment tubulose puncture needle are realized to find suitable puncture angle and position, sting device can be passed through at this time
Inner cavity radiography carries out auxiliary positioning and monitors cardiac pressure；Then firmly push tubulose puncture needle, needle point pass through atrial septum or room
Behind interval, conduit is sent into atrium sinistrum or right ventricle along tubulose puncture needle, tubulose puncture needle is then withdrawn from, punctures atrial septum or room
Interval operation is completed.
The above, only specific embodiments of the present invention cannot limit the range that invention is implemented with it, so it is equivalent
The displacement of component, or according to equivalent variations made by the invention patent protection scope and modification, should all still fall within what this patent was covered
Scope.In addition, between technical characteristic and technical characteristic in the present invention, between technical characteristic and technological invention, technological invention with
Use can be freely combined between technological invention.
Claims (10)
1. a kind of multifunctional heart interval tubulose sting device, which is characterized in that multifunctional heart interval tubulose punctures dress
It sets and includes:
Tubulose puncture needle, the tubulose puncture needle are made of Ni-Ti-based shape memory alloy comprising needle body and needle point, the needle body
For hollow tubular structure, the bending part of certain bending angle is preset in needle body certain close to needle point；
Metal protection protector, the part needle body and needle point sleeve close to needle point are loaded in the metal protection protector；
Direction instruction mark is installed on the tail portion of the tubulose puncture needle needle body, for determining the curved direction of the needle point；
After the tubulose puncture needle enters the chambers of the heart, after needle body certain of close needle point is heated, hardness increases and can be automatic
It is bent to the bending angle；
Preferably, the bending angle is 30-90 °, it is highly preferred that the bending angle is 45-60 °；
It is further preferred that the length of the bending part is 0.5-6cm, it is highly preferred that the length of the bending part is 1-3cm,
It is further preferred that the length of the bending part is 2-3cm.
2. multifunctional heart interval tubulose sting device according to claim 1, which is characterized in that described device further includes
The tail portion of stop,threeway, the stop,threeway and the tubulose puncture needle needle body is cooperatively connected；
Preferably, it is provided with length scale on the needle body, the start index of the length scale is located at needle body tail portion；
It is further preferred that the material of the stop,threeway is plastics；
It is further preferred that the direction instruction target material is also plastics.
3. multifunctional heart interval tubulose sting device according to claim 1 or 2, which is characterized in that punctured in tubulose
It is described by nickel when needle local environment temperature is lower than the ceiling temperature of the martensitic transformation temperature range of Ni-Ti-based shape memory alloy
In tubulose puncture needle made of Ti-based shape memory alloy, soft condition is presented in at least described bending part, easily deformable；In pipe
When shape puncture needle local environment temperature is higher than the lower limit temperature of the austenite transition temperature range of Ni-Ti-based shape memory alloy, institute
It states in the tubulose puncture needle made of Ni-Ti-based shape memory alloy, the hardness of at least described bending part increases, and the bending
Part can automatic bending to the bending angle；
Wherein, the martensitic transformation temperature range of Ni-Ti-based shape memory alloy is 0-30 DEG C, austenite transition temperature range
It is 15-35 DEG C.
4. multifunctional heart interval tubulose sting device according to claim 3, which is characterized in that the NiTi base shape
Memorial alloy includes NiTi alloy or NiTi-X alloy；Wherein, X is selected from one of Nb, Cu, Fe and Ag element or a variety of members
The combination of element；
Preferably, in NiTi alloy, the atomic ratio of Ni is 48-52at%, remaining is Ti；
It is further preferred that the atomic ratio of Ti element and Ni element is 0.8:1.1-1.2:0.9, the atom of X element in NiTi-X alloy
Percentage is less than 20%.
5. multifunctional heart interval tubulose sting device according to claim 1 or 2, which is characterized in that the needle body
Cross section includes annulus or polygon ring；
Preferably, the outer diameter of the cross section of the needle body or across the cross-section center diagonal line length be 0.2-3mm, internal diameter or
Diagonal line length across the cross-section center is 0.1-2.5mm；
It is highly preferred that the cross section of the needle body is annulus, the outer diameter of the annulus is 1-3mm, internal diameter 0.5-2mm.
6. multifunctional heart interval tubulose sting device according to claim 1 or 2, which is characterized in that the needle point
Oblique section is oval ring, and the angle of the oblique section and needle body is 10-60 °；
Preferably, the angle of the oblique section and needle body is 30-45 °.
7. multifunctional heart interval tubulose sting device according to claim 1 or 2, which is characterized in that the metal is protected
Sheath is hollow tube, and outer diameter 2-4mm, internal diameter is identical as the needle body outer diameter, the tail end of the metal protection protector be it is round table-like,
Its material includes stainless steel, aluminium, copper；
It is further preferred that the metal protection protector is the round tube of stainless steel material, outer diameter 2-3mm, the internal diameter of inner cavity is 1-
2mm。
8. multifunctional heart interval tubulose sting device according to claim 1 or 2, which is characterized in that the tubulose is worn
The length of pricker is 80-130cm.
9. the production method of the described in any item multifunctional heart interval tubulose sting devices of claim 1-8, which is characterized in that
The production method the following steps are included:
(1) nickel titanium-base shape memory alloy tubing is chosen, and makes needle point in one end of the tubing；Preferably, it is adopted in step (1)
It is machined into and grinds needle point or needle point is made using etch；
(2) tubing for having produced needle point to step (1) carries out shaping processing, and being precast with to will be close to the needle body end of needle point has
The bending part of certain bending angle；
It is further preferred that the setting treatment temperature is 350-650 DEG C, the setting treatment time is 180-2 minutes；It is highly preferred that institute
Stating setting treatment temperature is 400-650 DEG C, it is further preferred that the setting treatment temperature is 450-600 DEG C；
(3) ageing treatment is carried out to gained tubing after step (2) setting treatment or to the bending part；
It is further preferred that the temperature of the ageing treatment is not higher than the setting treatment temperature, the aging time is 360-5
Minute；It is more preferred still that the temperature of the ageing treatment is 0-200 DEG C lower than setting treatment temperature；Still further preferably, described
The temperature of ageing treatment is 300-600 DEG C；
(4) the part needle body and needle point sleeve that will be close to needle point again are loaded in metal protection protector, and direction instruction mark is installed on this
The tail portion of tubulose puncture needle needle body to get arrive the multifunctional heart interval tubulose sting device；
Preferably, production method further include: after direction instruction mark to be installed on to the tail portion of the tubulose puncture needle needle body, then by three
The tail portion of logical piston and the tubulose puncture needle needle body is cooperatively connected wears to get to the multifunctional heart interval tubulose
Thorn device.
10. the described in any item multifunctional heart interval tubulose sting devices of claim 1-8 be used as through inferior caval vein into
Enter atrium dextrum to puncture atrial septum or enter the application that left ventricle punctures the sting device of interventricular septum through peripheral arterial；
It preferably, is the geneva lower than Ni-Ti-based shape memory alloy by tubulose puncture needle local environment temperature setting before
After the ceiling temperature of body transition temperature range, artificial aligning is carried out to the tubulose puncture needle and is punctured again.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910762440.3A CN110448360A (en) | 2019-08-19 | 2019-08-19 | A kind of multifunctional heart interval tubulose sting device and preparation method thereof and application |
| PCT/CN2020/075647 WO2020207118A1 (en) | 2019-04-08 | 2020-02-18 | Puncture needle device for entering left ventricle through peripheral artery to puncture interventricular septum and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910762440.3A CN110448360A (en) | 2019-08-19 | 2019-08-19 | A kind of multifunctional heart interval tubulose sting device and preparation method thereof and application |
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| CN110448360A true CN110448360A (en) | 2019-11-15 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020207118A1 (en) * | 2019-04-08 | 2020-10-15 | 中国石油大学(北京) | Puncture needle device for entering left ventricle through peripheral artery to puncture interventricular septum and preparation method |
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