WO2020207118A1 - 用于经外周动脉进入左心室穿刺室间隔的穿刺针装置及制备方法 - Google Patents

用于经外周动脉进入左心室穿刺室间隔的穿刺针装置及制备方法 Download PDF

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Publication number
WO2020207118A1
WO2020207118A1 PCT/CN2020/075647 CN2020075647W WO2020207118A1 WO 2020207118 A1 WO2020207118 A1 WO 2020207118A1 CN 2020075647 W CN2020075647 W CN 2020075647W WO 2020207118 A1 WO2020207118 A1 WO 2020207118A1
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WIPO (PCT)
Prior art keywords
puncture needle
needle
puncture
left ventricle
tip
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PCT/CN2020/075647
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English (en)
French (fr)
Inventor
郝世杰
闫朝武
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中国石油大学(北京)
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Priority claimed from CN201910276461.4A external-priority patent/CN110623709A/zh
Priority claimed from CN201910762440.3A external-priority patent/CN110448360A/zh
Application filed by 中国石油大学(北京) filed Critical 中国石油大学(北京)
Publication of WO2020207118A1 publication Critical patent/WO2020207118A1/zh

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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

Definitions

  • the invention relates to a puncture needle device used to enter the left ventricle through a peripheral artery to puncture the interventricular septum and a preparation method thereof, and belong to the field of medical equipment devices.
  • Transcatheter cardiac atrial septal puncture is one of the commonly used clinical techniques. It provides an effective surgical path for interventional therapy into the left heart through the vein-right heart system. It is an indispensable method for many cardiac interventions, such as transcatheter atrial fibrillation radiofrequency Ablation, transcatheter mitral valvuloplasty, transcatheter left atrial ear closure, transcatheter atrial septal ostomy, etc.
  • the most commonly used clinical puncture devices are the Brockenbrough atrial septal puncture needle and the supporting Mullins puncture sheath system (St Jude Medical Inc).
  • Other rare puncture devices include devices such as atrial septal radiofrequency ablation needles.
  • the above-mentioned special devices for atrial septal puncture can meet most of the clinical needs, but there are deficiencies for some patients with significant changes in cardiac anatomy, including atrial septal bulging tumor, huge right atrium, and postoperative atrial septal sites.
  • the puncture angle of the above-mentioned puncture system is also greatly limited, and it is difficult to achieve a nearly vertical puncture angle.
  • the most commonly used Brockenbrough puncture needle is hard and difficult to bend.
  • the currently reported instruments and methods for transcatheter puncture of the ventricular septum of the heart mainly include the following three: [1] From the superior vena cava route, use the Brockenbrough puncture needle (St Jude Medical Inc) to enter the right ventricle to puncture the interventricular septum; [2 ]From the superior vena cava route, use a radiofrequency transseptal needle (NRG; Bayliss Medical, Montreal, Canada) to enter the right ventricle to puncture the interventricular septum; [3] via the superior vena cava route, use radiofrequency energy diathermy The metal guide wire connected to the pen (Diathermy pen radiofrequency energy) enters the right ventricle to puncture the interventricular septum.
  • the above three devices and methods all have major defects, which make it difficult to promote and apply clinically.
  • the above three methods must enter the right ventricular septum through the superior vena cava route, which makes it difficult to control the positioning and puncture direction when puncturing the interventricular septum.
  • the Brockenbrough puncture needle is a metal hollow needle, which is hard and difficult to bend. The position and angle of the right ventricular septum are different; 3.
  • the radiofrequency ablation needle for puncturing the interatrial septum or the guide wire connected to the radiofrequency energy diathermy pen improves the puncture angle, the radiofrequency ablation brings about the irreversibility of the puncture site and surroundings. Injury, the long-term prognosis is unclear.
  • the present invention provides a new puncture needle device for puncturing the interventricular septum.
  • the puncture needle device can realize safe and effective puncture of the cardiac interventricular septum through the peripheral artery, thereby providing a new method for entering the left ventricle path.
  • the present invention provides the following technical solutions:
  • the puncture needle device includes a puncture needle, a metal protective sleeve, and a tail marker.
  • the metal protective sleeve can be sleeved on the needle tip of the puncture needle and On part of the needle body, a tail marker is installed on the tail of the puncture needle;
  • the puncture needle is made of shape memory alloy and includes two parts: a needle body and a needle tip.
  • One end of the puncture needle is preset with a certain bending angle.
  • the bending angle of the puncture needle is 30-90°, and the end of the needle body of the puncture needle near the tail is provided with a length scale, which can display the length of the needle body that has entered the human body during use.
  • the puncture needle device used to enter the left ventricle through the peripheral artery to puncture the interventricular septum can also be called a multifunctional cardiac septum tubular puncture device.
  • NiTi or NiTi-X alloy where X is one or more elements selected from Nb, Cu, Fe, and Ag.
  • the atomic ratio of Ni is 48-52 at%, and the rest is Ti.
  • the atomic ratio of Ti to Ni is (0.8:1.1) to (1.2:0.9), and the atomic percentage of X is less than 20%.
  • the crystal structure When the temperature of the puncture needle is lower than the cooling phase transition temperature of its alloy, the crystal structure is B19' phase or B19 phase or R phase, showing a soft state, and the elastic modulus is 20-60GPa, which is easy to deform; When the temperature of the alloy rises above the phase transition temperature, the crystal structure changes to B2 phase, the hardness increases, the elastic modulus is 50-100 GPa, and the tip end of the puncture needle is automatically bent to a preset bending angle.
  • the cooling phase transition temperature of the puncture needle alloy is a certain temperature in the range of 0-30°C
  • the heating phase transition temperature is a certain temperature in the range of 15-35°C.
  • the specific cooling phase transition temperature and the heating phase transition temperature are caused by The alloy composition of the puncture needle is different.
  • the curved part of the puncture needle includes a needle tip and part of the needle body, and the length of the curved part of the puncture needle is 0.5-4 cm.
  • the preset bending angle of the puncture needle is 50-60°, and the length of the bending part is 1-3 cm. More preferably, the preset bending angle of the tip end of the puncture needle is 60°, and the length of the bending part is 2 cm.
  • the needle body of the puncture needle is a wire material, and its cross section can be round, square or polygonal, etc., and the diameter or the length of the diagonal line passing through the center is 0.5-2mm.
  • the needle body of the puncture needle is a round wire material with a diameter of 1 mm.
  • the puncture needle may also be a tubular puncture needle, the tubular puncture needle is made of nickel-titanium-based shape memory alloy, the needle body is a hollow tubular structure, and a certain bending angle is preset at a certain position of the needle body near the needle tip Bending part; when the tubular puncture needle enters the heart cavity, after a certain part of the needle body near the needle tip is heated, its hardness increases and can automatically bend to the bending angle.
  • the cross-section of the needle body includes a circular ring or a polygonal ring; preferably, the outer diameter of the cross-section of the needle body or the diagonal length passing through the center of the cross-section is 0.2-3mm, The inner diameter or the diagonal length passing through the center of the cross section is 0.1-2.5mm.
  • the oblique section of the needle tip may be an elliptical ring, and preferably, the angle between the oblique section and the needle body is 10-60°.
  • the device provided by the present invention may also include a three-way piston, which is matedly connected with the tail of the tubular puncture needle body.
  • the material of the three-way piston can be plastic.
  • the length of the puncture needle can be set according to specific usage conditions; preferably, the length of the puncture needle is 80-130 cm.
  • the tip of the puncture needle is tapered, and the taper is 0.1-0.3.
  • the shape of the tip of the puncture needle is conical, and the taper of the cone is 0.2.
  • the shape of the metal protective sleeve is a hollow tube, the outer diameter is 2-4mm, the inner diameter is the same as the outer diameter of the needle body of the puncture needle, one end of the metal protective sleeve is truncated, and the material can be stainless steel, aluminum, copper, etc., preferably Stainless steel is used to protect the needle tip and to assist in feeding the puncture needle into the catheter.
  • the metal protective sleeve is a circular tube made of metal material, with an outer diameter of 3 mm, an inner diameter of the inner cavity of 1 mm, and one end in a truncated cone shape.
  • the tail marker (or direction indicator) is made of plastic material and assembled on the tail of the puncture needle; the purpose of setting the tail marker is to determine the direction of the needle tip and to determine the direction of the puncture needle, which is convenient for control and Adjust the direction and position of the puncture needle in the left ventricle. In addition, for convenient operation, the marker can be disassembled and assembled.
  • the present invention also provides a method for preparing the above-mentioned puncture needle device for entering the left ventricle through the peripheral artery to puncture the interventricular septum.
  • the method includes wire preparation of the puncture needle, needle tip production, shaping treatment and surface treatment processes.
  • a preparation method of a puncture needle for entering the left ventricle through a peripheral artery to puncture the interventricular septum including the following steps:
  • Wire preparation wire drawing the shape memory alloy to prepare a wire
  • Needle tip production the needle tip is prepared by mechanical processing and grinding or the etching method to obtain the tapered tip;
  • the puncture needle is shaped, and the bending angle of the puncture needle tip (including the needle tip and part of the needle body) is shaped to 30-90°; then the puncture needle or the curved part of the puncture needle ( Needle tip and part of the needle body part) for aging treatment;
  • the preparation method may include the following steps:
  • step (2) Perform shaping treatment on the tube with the needle tip produced in step (1), so that the end of the needle body close to the needle tip is prefabricated into a bent part with a certain bending angle;
  • the chemical composition of the puncture needle is NiTi or NiTi-X alloy, where X is one or more elements selected from Nb, Cu, Fe, and Ag.
  • the diameter of the wire is 0.5-2mm.
  • the atomic ratio of Ni is 48-52 at%, and the rest is Ti.
  • the atomic ratio of Ti to Ni is (0.8:1.1) to (1.2:0.9), preferably (0.9:1) to (1.1:1), and the atomic percentage of X is less than 20 %.
  • step (2) the taper of the obtained needle tip is 0.1-0.3.
  • the length of the curved part of the puncture needle is preferably 0.5-4 cm.
  • the needle body and needle tip are equipped with a shaping device.
  • the shaping device of the needle body part (most of the needle body) is linear, and the shaping device at the end of the needle tip (needle tip + part of the needle body) is curved and curved.
  • the angle is 30-90°
  • the shaping treatment temperature is 350-650°C
  • the shaping treatment temperature is preferably 400-650°C, more preferably 450-600°C
  • the shaping treatment time is 180-2 minutes.
  • the shape of the puncture needle after shaping is shown in Figure 2. In general, the higher the setting temperature, the shorter the setting time required for the purpose of formulating the shape of the puncture needle.
  • the purpose of the aging treatment is to adjust the phase transition temperature of the puncture needle (including the heating phase transition temperature from soft to hard and the cooling phase transition temperature from hard to soft).
  • the aging treatment includes two methods: one method is to perform the aging treatment on the entire puncture needle, the aging temperature is 300-600°C (generally, the aging temperature is slightly lower than the setting temperature), preferably 300-550°C, more preferably 400 -500°C, the aging time is 360-5 minutes, preferably 180-10 minutes.
  • the puncture needle obtained by this treatment method is soft at low temperatures.
  • the needle tip After entering the human body, the whole becomes hard, and the needle tip automatically bends to the set angle ; Another way is to only aging the end of the puncture needle close to the needle tip, including the curved part of the puncture needle (needle tip and part of the needle body) and the other part of the needle body, about 2-30cm, the aging temperature is 300-600°C, preferably The temperature is 300-550°C, more preferably 400-500°C, and the aging time is 360-5 minutes.
  • the puncture needle obtained by this treatment method is soft at the tip end of the needle at low temperature, and most of the needle body has high hardness. , After entering the human body, the hardness of the needle body does not change much, the end of the needle tip automatically bends to the set angle, and the hardness increases.
  • the puncture needle is subjected to a two-step process of setting treatment and aging treatment, that is, setting setting and phase change temperature control are performed separately.
  • the aging temperature is generally not higher than the setting temperature.
  • the aging temperature is 0-200°C lower than the setting temperature.
  • the setting time is shorter and the aging time is longer; this can achieve better and more accurate shape setting of the puncture needle, and also better realize the adjustment of the phase transition temperature.
  • step (4) the surface of the needle body is pickled and cleaned.
  • the puncture needle Before use, put the puncture needle below the cooling phase transition temperature, such as ice-water mixture. At this time, the puncture needle is in the B19' phase or B19 phase or R phase, showing a soft state and easy to deform.
  • the puncture needle is manually straightened; After entering the heart, the temperature in the heart exceeds 30°C, which is higher than the warming phase transition temperature, and the needle tip is automatically bent to a preset bending angle under the action of temperature, the crystal structure changes to B2 phase, and the hardness increases.
  • the above-mentioned preparation method may further include: putting a part of the needle body and the needle tip close to the needle tip into a metal protective sheath, and installing a direction indicator on the tail of the tubular puncture needle body to obtain the result.
  • the puncture needle device used to enter the left ventricle through the peripheral artery to puncture the interventricular septum.
  • the above-mentioned preparation method may further include: installing a direction indicator on the tail of the tubular puncture needle body, and then matingly connect the three-way piston with the tail of the tubular puncture needle body, That is, the puncture needle device used to enter the left ventricle through the peripheral artery to puncture the interventricular septum is obtained.
  • the puncture needle device used to enter the left ventricle through the peripheral artery to puncture the interventricular septum can be made of memory alloy wire or memory
  • the specific technical solutions are as follows:
  • the present invention provides a multifunctional cardiac interval tubular puncture device, wherein the multifunctional cardiac interval tubular puncture device includes:
  • a tubular puncture needle is made of nickel-titanium-based shape memory alloy, which includes a needle body and a needle tip, the needle body is a hollow tubular structure, and a certain bending angle is preset at a certain position of the needle body near the needle tip Curved part
  • a metal protective cover, the part of the needle body and the needle tip close to the needle tip are sleeved in the metal protective cover;
  • a direction indicator which is installed on the tail of the tubular puncture needle body and is used to determine the direction in which the needle tip is bent;
  • the tubular puncture needle After the tubular puncture needle enters the heart cavity, after a certain part of the needle body near the needle tip is heated, its hardness increases and can automatically bend to the bending angle, so as to facilitate the puncture of the heart interval.
  • a bending part with a certain bending angle is preset at a certain position of the needle body close to the needle tip. It is obvious from this that the bending part includes the needle tip and part of the needle body close to the needle tip. ;
  • the length of the part of the needle body near the tip of the needle sheathed in the metal protective sheath should be greater than the length of the needle body included in the curved part.
  • the bending angle is 30-90°, more preferably, the bending angle is 45-60°.
  • the length of the curved portion is 0.5-6 cm, more preferably, the length of the curved portion is 1-3 cm, and further preferably, the curved portion The length of the part is 2-3cm.
  • the device further comprises a three-way piston, which is matedly connected with the tail of the tubular puncture needle body.
  • the material of the three-way piston is plastic.
  • the material of the direction indicator is also plastic.
  • a length scale is provided on the needle body, and the initial scale of the length scale is located at the tail of the needle body.
  • the present invention is provided with a length scale mark on the needle body, which can display the length of the needle body that has entered the human body during use.
  • the purpose of setting the direction indicator (tail marker) of the device of the present invention is to determine the direction in which the needle tip is bent, which is used to determine the bending direction of the tubular puncture needle (during the operation, with the help of real-time imaging with imaging equipment, the needle tip can be observed Bending direction) to facilitate control and adjustment of the direction and position of the tubular puncture needle in the right atrium or left ventricle;
  • the purpose of setting the three-way piston is to facilitate the heart chamber pressure measurement and the positioning of the contrast agent through the puncture needle.
  • the device in the device, preferably, when the ambient temperature of the tubular puncture needle is lower than the upper limit temperature of the martensite transformation temperature range of the nickel-titanium-based shape memory alloy, the nickel In the tubular puncture needle made of titanium-based shape memory alloy, at least the bent part is in a soft state and is easy to deform; the ambient temperature of the tubular puncture needle is higher than the austenite transformation temperature range of the nickel-titanium-based shape memory alloy At the lower limit temperature, in the tubular puncture needle made of nickel-titanium-based shape memory alloy, at least the hardness of the curved part increases, and the curved part can automatically bend to the bending angle;
  • the martensite transformation temperature range of the nickel-titanium-based shape memory alloy is 0-30°C, and the austenite transformation temperature range is 15-35°C.
  • the crystal structure when the ambient temperature of the tubular puncture needle is lower than the upper limit temperature of the martensitic transformation temperature range of its alloy, the crystal structure is B19' phase or B19 phase or R phase, and at least the bent part is soft State, the modulus of elasticity is 20-60GPa, which is easy to deform; when the ambient temperature is higher than the lower limit temperature of the austenite transformation temperature range of its alloy, the crystal structure transforms into the B2 phase, the hardness increases, and the elastic modulus is 50-100 GPa, at least the hardness of the bending part is increased, and the bending part can be automatically bent to the bending angle.
  • the martensite transformation temperature range and the austenite transformation temperature range differ depending on the composition of the tubular piercing needle alloy.
  • the nickel-titanium-based shape memory alloy includes NiTi alloy or NiTi-X alloy; wherein, X is one selected from Nb, Cu, Fe, and Ag.
  • X is one selected from Nb, Cu, Fe, and Ag.
  • the atomic ratio of Ni is 48-52 at%, and the rest is Ti;
  • the atomic ratio of Ti element to Ni element is 0.8:1.1-1.2:0.9, and the atomic percentage of X element is less than 20%.
  • the cross section of the needle body includes a circular ring or a polygonal ring
  • the outer diameter of the cross section of the needle body or the diagonal length passing through the center of the cross section is 0.2-3mm, and the inner diameter or the diagonal length passing through the center of the cross section is 0.1-2.5mm;
  • the cross-section of the needle body is a circular ring, the outer diameter of the circular ring is 1-3 mm, and the inner diameter is 0.5-2 mm.
  • the oblique section of the needle tip is an elliptical ring, and the angle between the oblique section and the needle body is 10-60°;
  • the angle between the oblique section and the needle body is 30-45°.
  • the metal protective sleeve is a hollow tube with an outer diameter of 2-4 mm, and the inner diameter is the same as the outer diameter of the needle.
  • the end (the end facing away from the opening direction of the metal protective sleeve is the tail end) is truncated cone-shaped, and its materials include stainless steel, aluminum, and copper;
  • the metal protective sleeve is a circular tube made of stainless steel, with an outer diameter of 2-3 mm and an inner diameter of the inner cavity of 1-2 mm.
  • the metal protective sleeve is used to protect the needle tip and can assist (facilitate) the delivery of the tubular puncture needle into the sheath.
  • the length of the tubular puncture needle can be set according to specific usage conditions.
  • the length of the tubular puncture needle is 80-130 cm.
  • the present invention also provides a manufacturing method of the multifunctional cardiac septum tubular puncture device, wherein the manufacturing method includes the following steps:
  • step (2) Perform shaping treatment on the tube with the needle tip produced in step (1), so as to preset the end of the needle body close to the needle tip with a certain bending angle;
  • the needle point is ground by mechanical processing or the needle point is manufactured by the etching method.
  • the setting treatment temperature is 350-650°C, and the setting treatment time is 180-2 minutes; more preferably, the The shaping treatment temperature is 400-650°C, and further preferably, the shaping treatment temperature is 450-600°C.
  • the higher the setting temperature the shorter the setting time required.
  • the purpose of the shaping treatment is to formulate the shape of the tubular puncture needle, and the shaping treatment can be carried out according to the following steps:
  • the pipe with the needle tip produced in step (1) is equipped with a setting device (a conventional device used in the field), wherein the setting device for the bending part is a bending setting device with a specific bending angle, and the setting device used outside the bending part It is a linear shaping device.
  • a setting device a conventional device used in the field
  • the setting device for the bending part is a bending setting device with a specific bending angle
  • the setting device used outside the bending part It is a linear shaping device.
  • the temperature of the aging treatment is not higher than the setting treatment temperature, and the aging treatment time is 360-5 minutes; More preferably, the temperature of the aging treatment is 0-200°C lower than the temperature of the setting treatment; further preferably, the temperature of the aging treatment is 300-600°C.
  • the purpose of the aging treatment is to adjust the phase transition temperature of the tubular puncture needle (including the austenite transition temperature from soft to hard and the Hard and soft martensite transformation temperature)
  • the aging treatment process includes two methods: one method is to perform aging treatment on the entire tubular puncture needle (the tube obtained after the sizing treatment), and the aging treatment temperature is 300-600°C ( Generally, the aging treatment temperature is slightly lower than the setting temperature.
  • the aging treatment temperature is 0-200°C lower than the setting treatment temperature), preferably 300-550°C, more preferably 400-500°C, and the aging treatment time is 360-5 Minutes, preferably 180-10 minutes;
  • the tubular puncture needle obtained by this treatment is soft as a whole at low temperature, and the whole becomes hard after entering the human body, and the needle tip is automatically bent to a set angle;
  • the other method is to only The end of the tubular puncture needle close to the needle tip, including the curved part of the tubular puncture needle (needle tip and part of the needle body) and the other part of the needle body, a total of about 2-30cm for aging treatment,
  • the aging temperature is 300-600°C, preferably 300-550°C , More preferably 400-500°C, and the aging treatment time is 360-5 minutes.
  • the curved part of the tip end of the tubular puncture needle obtained by this treatment method is soft at low temperature, and most of the needle body has high hardness and enters the human body. After that, the hardness of the needle body does not change much, and one end of the needle tip automatically bends to the set angle, and the hardness increases.
  • the tubular puncture needle is subjected to two-step treatments of shaping treatment and aging treatment in sequence, that is, shaping and phase change temperature control are performed separately, and the aging treatment temperature is generally not higher than the shaping treatment temperature, preferably Ground, the aging treatment temperature is 0-200°C lower than the setting treatment temperature, the setting treatment time is shorter, and the aging treatment time is longer; this can achieve better and more accurate shape setting of the tubular puncture needle, but also better Realize the adjustment of phase transition temperature.
  • the manufacturing method further includes performing surface cleaning treatment on the product obtained after the aging treatment in step (3), wherein the surface cleaning treatment is a pickling cleaning treatment on the surface.
  • the manufacturing method further includes: installing the direction indicator on the tail of the tubular puncture needle body, and then matingly connect the three-way piston with the tail of the tubular puncture needle body , The multifunctional cardiac interval tubular puncture device is obtained.
  • the present invention also provides the application of the multifunctional cardiac septum tubular puncture device as a puncture device for puncturing the atrial septum through the inferior vena cava into the right atrium or through the peripheral artery into the left ventricle to puncture the interventricular septum.
  • the ambient temperature of the tubular puncture needle is set to be lower than the upper limit temperature of the martensite transformation temperature range of the nickel-titanium-based shape memory alloy. , The tubular puncture needle is manually straightened and then punctured.
  • the ambient temperature of the tubular puncture needle can be set to be lower than the upper limit temperature of the martensite transformation temperature range of the nickel-titanium-based shape memory alloy (for example, the tubular puncture needle can be placed in an ice-water mixture)
  • the tubular puncture needle is in B19' phase or B19 phase or R phase, showing a soft state and easy to deform.
  • the tubular puncture needle can be artificially straightened; after the tubular puncture needle enters the heart, the temperature in the heart exceeds 30°C, It is higher than the lower limit temperature of the austenite transformation temperature range of the nickel-titanium-based shape memory alloy, and the needle tip is automatically bent to a preset bending angle under the effect of temperature, the crystal structure changes to the B2 phase, and the hardness increases.
  • the puncture needle when the puncture needle is placed in a mixture of ice and water outside the body, it presents a soft state, is easy to deform, and is convenient for entering the left ventricle through the peripheral artery.
  • the puncture needle enters the left ventricle the needle tip automatically bends to a preset angle and the hardness increases significantly.
  • the hollow lumen can also assist in realizing the function of angiographic positioning and monitoring the internal pressure of the heart.
  • the interventricular septal puncture needle of the present invention has special temperature-controlled deformation and accompanying hardness change characteristics (that is, the body temperature changes the hardness and bending angle by itself), can provide an excellent needle angle for cardiac septal puncture, and effectively complete the interventricular septum Puncture task;
  • the puncture needle of the present invention has various preset angles at the distal end, which can complete different atrial septal and ventricular septal puncture tasks;
  • the tubular puncture needle can also assist in realizing the function of angiographic positioning and monitoring the internal pressure of the heart through the hollow lumen.
  • the puncture needle involved in the present invention has little collateral damage to the interventricular septum and puncture surrounding tissues through the physical puncture method, and the potential harm caused by it is greatly reduced. Its safety is better than the three methods in the prior art, and can be more Interval puncture was attempted.
  • the puncture needle of the present invention can pass through the peripheral artery, mainly but not limited to the femoral artery, and can complete the ventricular septal puncture from the artery, avoiding the disadvantage that the three methods in the prior art can only puncture the vein.
  • the needle body of the puncture needle of the present invention is small, and the operation is safe, and the interventricular septal puncture can be tried many times.
  • Figure 1 is a schematic diagram of the puncture needle device of the present invention.
  • Figure 2 is a schematic diagram of the preset curvature of the puncture needle of the present invention after heating.
  • Figure 3 is a physical diagram of the puncture needle of the present invention after artificial straightening at the temperature of ice water outside the body.
  • Fig. 4 is a physical diagram of the puncture needle of the present invention automatically bending at a temperature of about 35°C.
  • Fig. 5 is a schematic structural diagram of a tubular puncture device provided by the present invention.
  • Fig. 6 is a schematic diagram of the preset curvature of the tubular puncture needle after heating in a specific embodiment of the present invention.
  • the puncture needle device used to enter the left ventricle through the peripheral artery to puncture the interventricular septum and the preparation method will be further described below in conjunction with the accompanying drawings and embodiments.
  • a puncture needle device made of shape memory alloy wire made of shape memory alloy wire:
  • the puncture needle device of the present invention includes: a puncture needle 2, a metal protective cover 3, and a tail marker (or direction indicator) 1.
  • the puncture needle 2 is made of shape memory alloy and includes a needle body and a needle tip. One end of the puncture needle tip is preset with a certain bending angle, and the bending angle is 30-90°; the end near the tail of the needle body has a scale mark (identifying the puncture needle 2), it can display the length of the needle body that has entered the human body when in use; the metal protective sleeve 3 is sleeved on the tip and part of the needle body of the puncture needle 2, and the metal protective sleeve 3 protects the needle tip and assists in feeding the puncture needle 2 into the catheter ,
  • the shape is a hollow tube with a truncated cone shape at one end.
  • the tail marker 1 is installed on the tail of the puncture needle 2 and exposed outside the body during use. The tail marker 1 is used to determine the bending direction of the needle tip and
  • the chemical composition of the puncture needle 2 1) NiTi alloy, atomic ratio Ti-48-52at% Ni; or, 2) NiTi-X alloy, atomic ratio of Ti:Ni element is (0.8:1.1) ⁇ (1.2:0.9) ), preferably (0.9:1) to (1.1:1), and the atomic percentage of X element is less than 20%.
  • the puncture needle 2 needle body shape characteristics wire (the cross section can be round, square, polygon), diameter: 0.5-2mm.
  • the shape characteristics of the tip of the puncture needle 2 cone; the preset bending angle is 30-90° after entering the heart, as shown in Figure 2; the length of the bending part ranges from 0.5-4cm.
  • the phase transition temperature of NiTi or NiTi-X alloy is different due to the different composition; the cooling phase transition of NiTi or NiTi-X alloy at any temperature in the range of 0-30°C, the puncture needle becomes soft; when the temperature is increased to 20-35°C At any temperature within the range, a phase change occurs, the puncture needle becomes hard, and the needle tip is bent to a preset angle.
  • the crystal structure is B19' phase or B19 phase or R phase, showing a soft state and easy to deform; when the puncture needle enters the heart, the needle tip will automatically bend to the preset bending angle , The crystal structure changes to B2 phase and the hardness increases.
  • the preparation process of the puncture needle 2 includes: wire preparation-needle tip preparation-shaping treatment-surface treatment. First, wire drawing to prepare the wire with a diameter of 0.5-2mm, then the needle tip is prepared by grinding the needle tip or etching method, shaping treatment (temperature 400-650 °C) and aging treatment, and finally the needle body surface is pickled and cleaned.
  • Shaping treatment The needle body and needle tip are equipped with a shaping device.
  • the shaping device of the needle body is linear, and the shaping device of the needle tip is curved.
  • the bending angle is 30-90°, and the shaping temperature is 400-650°C.
  • the time is 180-2 minutes, and the shape of the puncture needle after setting treatment is shown in Figure 2.
  • the purpose of aging treatment is to adjust the phase transition temperature of the puncture needle (the temperature from hard to soft and from soft to hard).
  • One way is to age the puncture needle as a whole, with an aging temperature of 300-600 °C, the aging time is 360-5 minutes.
  • the puncture needle obtained by this treatment method is soft at low temperature. After entering the human body, the whole becomes hard, and the needle tip automatically bends to the set angle; another method is to only apply the puncture needle
  • the aging temperature is 300-600°C, the aging time is 360-5 minutes, and the aging temperature is generally slightly lower than the setting temperature.
  • the puncture needle obtained by this treatment method has the tip at low temperature.
  • the attachment part is soft, and the needle body part has a high hardness. After entering the human body, the needle body hardness does not change much, and the needle tip part automatically bends to the set angle, and the hardness increases.
  • Preparation of a puncture needle with a chemical composition of NiTi (Ti-51at%Ni) alloy (1) Melting NiTi alloy ingots, forging and wire drawing processing into a wire with a diameter of 1mm and a circular cross-section, and cut the wire with a suitable length for implementation Further processing; (2) Machining and grinding the needle tip with a taper of 0.2 (the needle tip length is 0.5cm); (3) The shaping treatment, first install a shaping device at the needle tip, and preset the bending angle of the needle tip to 60° and length Then put the puncture needle in the shaping treatment furnace, the shaping temperature is 500°C, and the shaping time is 10 minutes.
  • the bending part of the tip of the needle is aged at 450°C and the aging time is 30 minutes; (4) go Surface pickling cleaning treatment; (5) Function test: When the puncture needle is placed in a mixture of ice and water, the needle tip is soft and straightened (as shown in Figure 3), and then the heart temperature is simulated, and the puncture needle is placed at approximately In 35°C warm water, the needle tip automatically bends to a preset angle when heated, and the needle tip hardness increases (as shown in Figure 4).
  • the metal protective sleeve is a circular tube made of metal with an outer diameter of 3mm, an inner diameter of the inner cavity of 1mm, and a truncated cone shape at one end.
  • One end of the metal protective sleeve is round cone-shaped and made of stainless steel, which is used to protect the needle tip and assist in feeding the puncture needle into the catheter.
  • the tail marker is made of plastic material, which can be disassembled and assembled on the tail of the puncture needle; it is used to determine the bending direction of the puncture needle, which is convenient for controlling and adjusting the direction and position of the puncture needle in the left ventricle.
  • NiTiNb alloy ingots are smelted, and then forged and wire drawn into a diameter of 1mm and a cross section For round wire, cut a suitable length of wire for further processing; (2) Machining to grind a needle tip with a taper of 0.2; (3) For shaping treatment, first install a shaping device at the needle tip and preset the needle tip bending angle 50° and 2cm in length, then put the puncture needle in the shaping treatment furnace, the shaping temperature is 530°C, the shaping time is 15 minutes, and finally the bending part of the tip end of the needle is aged at 400°C and the aging time is 60 minutes; ( 4) Carry out surface pickling and cleaning treatment; (5) Function test: When the puncture needle is placed in an ice-water mixture, the needle tip is soft and straightened, and then the heart temperature is simulated, and the
  • the metal protective sleeve is a circular tube made of metal with an outer diameter of 3mm, an inner diameter of the inner cavity of 1mm, and a truncated cone shape at one end.
  • One end of the metal protective sleeve is round cone-shaped, and the material can be stainless steel, which is used to protect the needle tip and assist in feeding the puncture needle into the catheter.
  • the tail marker is made of plastic material, which can be disassembled and assembled on the tail of the puncture needle; it is used to determine the bending direction of the puncture needle, which is convenient for controlling and adjusting the direction and position of the puncture needle in the left ventricle.
  • the puncture needle tip part When in use, first place the puncture needle tip outside the body below the cooling phase transition temperature, such as below 20 °C, the puncture needle tip part is artificially straightened; then the puncture needle is assisted by the metal protective sleeve to be sent into the peripheral artery The catheter passes through the hollow cavity of the catheter, and the puncture needle enters the left ventricle of the patient under the guidance of the catheter.
  • the cooling phase transition temperature such as below 20 °C
  • the puncture needle automatically bends to a preset angle, that is, the bending angle range is 30 under the influence of human body temperature (that is, when the temperature is higher than 30°C) -90°, the length of the curved part ranges from 0.5-4cm; then operate the tail device of the puncture needle to adjust the direction and position of the puncture needle to find the appropriate puncture angle and position, and then push the puncture needle forcefully.
  • the needle tip passes through the interventricular septum, insert the catheter Along the puncture needle into the right ventricle, and then withdraw the puncture needle, the operation of puncturing the interventricular septum is completed.
  • the puncture needle of the present invention has little incidental damage to the interventricular septum and the surrounding tissues of the puncture, and the potential harm it brings is greatly reduced, and its safety is good.
  • the needle body of the puncture needle of the present invention is small, and the operation is safe, and the interventricular septal puncture can be tried many times.
  • a puncture needle device made of Nitinol-based shape memory alloy tubing:
  • FIG. 5 is a schematic structural diagram of the multifunctional cardiac septum tubular puncture device provided by the present invention, the device includes:
  • the tubular puncture needle 2 is made of nickel-titanium-based shape memory alloy and includes a needle body and a needle tip.
  • the needle body has a hollow tubular structure and is pre-set with a certain curve near the needle tip. The curved part of the angle;
  • Direction indicator (or tail marker) 1, which is installed on the tail of the tubular puncture needle body, exposed outside the body when in use, and used to determine the direction in which the needle tip is bent, so as to facilitate control and adjustment of the tubular puncture needle The direction and position of the right atrium or left ventricle;
  • the tubular puncture needle After the tubular puncture needle enters the heart cavity, after a certain part of the needle body near the needle tip is heated, its hardness increases and can automatically bend to the bending angle, so as to facilitate the puncture of the heart interval.
  • the bending angle is 30-90°.
  • the length of the curved portion is 0.5-6 cm.
  • the device further includes a three-way piston, and the material of the three-way piston is plastic.
  • the material of the direction indicator is also plastic.
  • the nickel-titanium-based shape memory alloy includes NiTi alloy or NiTi-X alloy; wherein, X is one element or a combination of multiple elements selected from Nb, Cu, Fe, and Ag;
  • NiTi alloy the atomic ratio of Ni is 48-52at%, and the rest is Ti;
  • the atomic ratio of Ti element to Ni element is 0.8:1.1-1.2:0.9, and the atomic percentage of X element is less than 20%.
  • the phase transition temperature of NiTi alloy or NiTi-X alloy is different due to the different composition; the martensite phase transition temperature of NiTi alloy or NiTi-X alloy is 0-30°C, when the ambient temperature of the tubular puncture needle is 0- At any temperature in the range of 30°C, the tubular puncture needle becomes soft; when the ambient temperature rises to any temperature in the range of 20-35°C, austenite transformation occurs, the tubular puncture needle becomes hard, and the needle tip is bent To the preset angle.
  • the crystal structure when the external temperature of the tubular puncture needle 2 is lower than 20°C, the crystal structure is B19' phase or B19 phase or R phase, showing a soft state and easy to deform; when the tubular puncture needle enters the heart, the needle tip will automatically bend to the preheated position after being heated. Set the bending angle, the crystal structure changes to B2 phase, and the hardness increases.
  • the cross-section of the needle body includes a circular ring or a polygonal ring; the outer diameter of the cross-section of the needle body or the diagonal length passing through the center of the cross-section is 0.2-3mm, and the inner diameter or the cross-section The diagonal length passing through the center of the cross section is 0.1-2.5 mm.
  • the oblique section of the needle tip is an elliptical ring, and the angle between the oblique section and the needle body is 10-60°.
  • the metal protective sleeve is a hollow tube with an outer diameter of 2-4mm, and the inner diameter is the same as the outer diameter of the needle body.
  • the tail end of the metal protective sleeve is truncated, and its material includes stainless steel and aluminum. ,copper.
  • the length of the tubular puncture needle is 80-130 cm.
  • the needle body is provided with a length scale, and the starting scale of the length scale is located at the tail of the needle body.
  • the device further includes a three-way piston 4 which is matedly connected to the tail of the tubular puncture needle 2.
  • the manufacturing method of the multifunctional cardiac interval tubular puncture device provided by the present invention includes the following steps:
  • step (2) Perform shaping treatment on the tube with the needle tip produced in step (1), so that the end of the needle body close to the needle tip is prefabricated into a bent part with a certain bending angle;
  • the temperature of the aging treatment is not higher than the temperature of the setting treatment, and the time of the aging treatment is 360-5 minutes; still more preferably, the temperature of the aging treatment is 0-200°C lower than the temperature of the setting treatment ; Still further preferably, the temperature of the aging treatment is 300-600 °C;
  • the needle tip in step (1), can be made by mechanical processing or by etching.
  • step (2) the purpose of the shaping treatment is to formulate the shape of the tubular puncture needle, and the shaping treatment can be carried out according to the following steps:
  • the pipe with the needle tip produced in step (1) is equipped with a setting device (a conventional device used in the field), wherein the setting device for the bending part is a bending setting device with a specific bending angle, and the setting device used outside the bending part It is a linear shaping device;
  • the shaping treatment temperature is 350-650°C, and the shaping treatment time is 180-2 minutes; the shape of the tubular puncture needle after the shaping treatment is shown in FIG. 6.
  • the purpose of the aging treatment is to adjust the phase transformation temperature of the tubular puncture needle (including the austenite transformation temperature from soft to hard and the martensite from hard to soft Phase transition temperature), the aging treatment process includes two methods: one method is to perform aging treatment on the entire tubular puncture needle (tube obtained after sizing treatment), the aging treatment temperature is 300-600°C, and the aging treatment time is 360-5 Minutes; the tubular puncture needle obtained by this treatment is soft as a whole at low temperature, and the whole becomes hard after entering the human body, and the needle tip is automatically bent to a set angle; the other method is to only apply the tubular puncture needle to the end of the needle , Including the curved part of the tubular puncture needle (needle tip and part of the needle body) and another part of the needle body (the length of the curved part and the other part of the needle body is about 2-30cm) for aging treatment, the aging treatment temperature is 300-600°C, aging treatment The time is
  • the aging treatment temperature is generally slightly lower than the setting treatment temperature.
  • the curved part of the tip end of the tubular puncture needle obtained by this treatment method is soft at low temperature, and most of the needle body has high hardness and enters the human body. After that, the hardness of the needle body does not change much, and one end of the needle tip automatically bends to the set angle, and the hardness increases.
  • the method further includes performing surface pickling cleaning treatment on the product obtained after the aging treatment in step (3).
  • This embodiment provides a multifunctional cardiac interval tubular puncture device, wherein the multifunctional cardiac interval tubular puncture device includes:
  • a tubular puncture needle is made of NiTi (the atomic ratio of Ti is 51at%, the atomic ratio of Ni is 49at%) alloy, which includes a needle body and a needle tip, the needle body is a hollow circular tubular structure (outer The diameter is 1.2mm, the inner diameter is 0.8mm), a 60° bending part (length 2cm) is preset at a certain place of the needle body near the tip of the needle.
  • the bent part includes the tip (length of 0.5cm) and a part Needle body
  • the oblique section of the needle tip is an elliptical ring, and the angle between the oblique section and the needle body is 30°;
  • a metal protective sleeve, the part of the needle body and the needle tip close to the needle tip are sleeved in the metal protective sleeve;
  • the metal protective sleeve is a hollow round tube made of stainless steel, with an outer diameter of 3mm, and an inner diameter of 1.2. mm, the end of the metal protective sleeve is truncated;
  • the direction indicator can be disassembled and assembled on the tail of the tubular puncture needle body. It is made of plastic material. It is exposed outside the body during use and is used to determine the bending direction of the needle tip to facilitate control and adjustment of the tubular puncture needle in the right atrium or left The direction and position in the ventricle;
  • a three-way piston, the three-way piston is matedly connected with the tail of the tubular puncture needle body;
  • the martensite transformation temperature of the NiTi alloy used in this embodiment is 0-30°C.
  • the ambient temperature of the tubular puncture needle is any temperature in the range of 0-30°C
  • the tip of the tubular puncture needle becomes soft
  • austenite transformation occurs, the tip of the tubular puncture needle becomes hard, and the tip of the needle is bent to a preset angle (that is, 60°).
  • step (3) Carry out the shaping treatment on the tube with the needle tip produced in step (2), so as to prefabricate the end of the needle body close to the needle tip into a curved part with a certain bending angle, specifically: the tube with the needle tip produced in step (2)
  • a sizing device (a conventional device used in this field) is added, wherein the sizing device of the curved part is a curved sizing device with a bending angle of 60°, and the sizing device used outside the curved portion is a linear sizing device; then the tube is punctured
  • the needle is placed in a shaping furnace for processing, the shaping temperature is 500°C, and the shaping time is 10 minutes;
  • the end of the tubular puncture needle close to the needle tip, including the curved part of the tubular puncture needle (needle tip and part of the needle body) and the other part of the needle body (the length of the curved part and the other part of the needle body is about 2-30cm) is aging treated.
  • the temperature is 450°C, and the aging time is 30 minutes;
  • Step (3) The product obtained after the aging treatment is subjected to surface pickling cleaning treatment to obtain a tubular puncture needle made of NiTi (Ti-51at%Ni) alloy;
  • the tubular puncture needle produced in this example When the tubular puncture needle produced in this example is placed in a mixture of ice and water, the needle tip is soft and straightened. Then, to simulate the temperature in the heart, the tubular puncture needle is placed in warm water at about 35°C, and the needle tip automatically bends when heated. The angle is preset (60°), and the needle tip hardness is increased.
  • the multifunctional cardiac interval tubular puncture device is obtained.
  • This embodiment provides a multifunctional cardiac interval tubular puncture device, wherein the multifunctional cardiac interval tubular puncture device includes:
  • the tubular puncture needle is made of NiTiNb alloy (the atomic ratio of Ti and Ni is 0.9:1, and the atomic percentage of Nb is 10%), which includes a needle body and a needle tip, and the needle body is a hollow circle Shaped tubular structure (outer diameter of 1mm, inner diameter of 0.6mm), a 50° bending part (length of 2cm) is preset at a certain position of the needle body close to the tip of the needle, wherein the bent part includes the tip of the needle (the length of which is 0.3 cm) and part of the needle body;
  • the oblique section of the needle tip is an elliptical ring, and the angle between the oblique section and the needle body is 20°;
  • a metal protective sleeve, the part of the needle body and the needle tip close to the needle tip are sleeved in the metal protective sleeve;
  • the metal protective sleeve is a hollow round tube made of stainless steel, with an outer diameter of 3mm, and an inner diameter of 1cm which is the same as the outer diameter of the needle body ,
  • the end of the metal protective sleeve is round cone shape;
  • the direction indicator can be disassembled and assembled on the tail of the tubular puncture needle body. It is made of plastic material. It is exposed outside the body during use and is used to determine the bending direction of the needle tip to facilitate control and adjustment of the tubular puncture needle in the right atrium or left The direction and position in the ventricle;
  • a three-way piston, the three-way piston is matedly connected with the tail of the tubular puncture needle body;
  • the martensite transformation temperature of the NiTi alloy used in this embodiment is 0-30°C.
  • the ambient temperature of the tubular puncture needle is any temperature in the range of 0-30°C, the tubular puncture needle becomes soft;
  • the ambient temperature rises to any temperature in the range of 15-35°C austenite transformation occurs, the tubular puncture needle becomes hard, and the needle tip is bent to a preset angle (that is, 60°).
  • step (3) Carry out the shaping treatment on the tube with the needle tip produced in step (2), so as to prefabricate the end of the needle body close to the needle tip into a curved part with a certain bending angle, specifically: the tube with the needle tip produced in step (2)
  • a sizing device (a conventional device used in this field) is added, wherein the sizing device for the curved part is a curved sizing device with a bending angle of 50°, and the sizing device used outside the curved portion is a linear sizing device; then the tube is punctured
  • the needle is placed in a shaping furnace for treatment, the shaping temperature is 530°C, and the shaping time is 15 minutes;
  • the end of the tubular puncture needle close to the needle tip including the curved part of the tubular puncture needle (needle tip and part of the needle body) and another part of the needle body (the length of the curved part and the other part of the needle body is about 2-30 cm), and the aging treatment temperature 400°C, aging time is 60 minutes;
  • Step (3) The product obtained after the aging treatment is subjected to surface pickling cleaning treatment to obtain a tubular puncture needle made of NiTi (Ti-51at%Ni) alloy;
  • the tubular puncture needle produced in this example When the tubular puncture needle produced in this example is placed in a mixture of ice and water, the needle tip is soft and straightened. Then, to simulate the temperature in the heart, the tubular puncture needle is placed in warm water at about 35°C, and the needle tip automatically bends when heated. The angle is preset (50°), and the needle tip hardness is increased.
  • the multifunctional cardiac interval tubular puncture device is obtained.
  • the tip of the tubular puncture needle is first placed in an environment that is lower than the upper limit temperature of the martensite transformation temperature of the nickel-titanium-based shape memory alloy in vitro, such as lower than 20 Under the environment of °C, the tip of the tubular puncture needle is artificially straightened; then the tubular puncture needle is assisted by the metal protective sleeve to be fed into the catheter placed in the peripheral artery or inferior vena cava, through the hollow cavity of the catheter, and guide the catheter Lower the tubular puncture needle into the right atrium or left ventricle of the patient.
  • the tubular puncture needle will automatically bend to a preset angle under the influence of human body temperature (that is, when the temperature is higher than 30°C), that is, the bending angle range is 30-90°, and the bending part length range 0.5-6cm; Operate the tubular puncture needle tail device to adjust the direction and position of the tubular puncture needle to find the appropriate puncture angle and position.
  • the puncture device can be used to assist in positioning and monitor the cardiac pressure; then use force Push the tubular puncture needle, after the needle tip passes through the atrial septum or ventricular septum, the catheter is sent along the tubular puncture needle into the left atrium or right ventricle, and then the tubular puncture needle is withdrawn, and the operation of puncturing the atrial septum or ventricular septum is completed.

Abstract

一种用于经外周动脉进入左心室穿刺室间隔的穿刺针装置，包括穿刺针（2）、金属保护套（3）和尾部标识物（1）；穿刺针（2）由形状记忆合金制成，包括针体和针尖两部分，穿刺针（2）的针尖一端预置30°-90°的弯曲角度。当穿刺针（2）置于体外冰水混合物中时，呈现柔软状态，易于变形，便于经外周动脉进入左心室。当穿刺针（2）进入左心室后针尖部位自动弯曲至预先设置角度且针体硬度显著增加。

Description

用于经外周动脉进入左心室穿刺室间隔的穿刺针装置及制备方法 技术领域
本发明涉及一种用于经外周动脉进入左心室穿刺室间隔的穿刺针装置及制备方法，属于医疗器械装置领域。
背景技术
心脏房间隔穿刺背景：
经导管心脏房间隔穿刺是临床常用技术之一，为经静脉-右心系统进入左心进行介入治疗提供有效的手术路径，是众多心脏介入术式不可或缺的方法，如经导管心房颤动射频消融术，经导管二尖瓣球囊成形术，经导管左心房耳封堵术，经导管房间隔造口术等。目前临床常用的穿刺装置主要是Brockenbrough房间隔穿刺针和配套的Mullins穿刺鞘系统(St Jude Medical Inc)。其它少见的穿刺装置包括房间隔射频消融穿刺针等装置。上述这些房间隔穿刺专用器械能够满足大部分临床需求，然而对一些心脏解剖结构明显改变的患者则存在不足，包括合并房间隔膨凸瘤，巨大右心房，房间隔部位术后等。另外，基于穿刺针的物理特性和经皮经导管路径的限制，上述穿刺系统的穿刺角度也大大受限，难以达到近于垂直的穿刺角度，其中临床最常用的Brockenbrough穿刺针硬度大且难以弯曲，通常斜行穿刺房间隔。因此临床上需要一种全新的房间隔穿刺针系统解决这些难题。
心脏室间隔穿刺背景：
经皮经导管穿刺心脏室间隔在临床上有巨大的需求，能够为经右心系统进入左心系统提供便捷通道。近些年来，虽然有不同穿刺器械和方法被提出，然而受材料和方法学的限制，至今尚无安全可靠的器械和方法能够在临床获得推广应用。因此，目前临床上亟需一种全新的心脏室间隔穿刺器械和方法解决这一难题。
目前已经报道的经导管穿刺心脏室间隔的器械和方法主要包括以下三种：[1]从上腔静脉途径，使用房间隔Brockenbrough穿刺针(St Jude Medical Inc)进入右室穿刺室间隔；[2]从上腔静脉途径，使用房间隔射频消融穿刺针(Radiofrequency transseptal needle，NRG；Bayliss Medical,Montreal,Canada)进入右室穿刺室间隔；[3]经上腔静脉途径，使用与射频能量透热笔(Diathermy pen radiofrequency energy)相连的金属导丝进入右室穿刺室间隔。上述三种器械和方法均存在重大缺陷，造成临床上难以推广应用。一、上述三种方法均必须经上腔静脉途径进入右室穿刺室间隔，这造成穿刺室间隔时定 位和穿刺方向难以控制；二、Brockenbrough穿刺针是金属空心针，硬度大且难以弯曲，穿刺右室室间隔的部位和角度差；三、穿刺房间隔的射频消融穿刺针或连接射频能量透热笔的导丝虽然改善了穿刺的角度，但射频消融带来穿刺部位和周围的不可逆性附带损伤，远期预后尚不清楚。
为了解决目前存在的问题，亟需开发一种新的进入左心室路径的方法和穿刺针装置。
发明内容
本发明提供了一种全新穿刺室间隔的穿刺针装置，采用该穿刺针装置能够实现安全有效的经外周动脉穿刺心脏室间隔，从而提供一种新的进入左心室路径的方法。
为实现上述目的，本发明提供了如下技术方案：
一种用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，该穿刺针装置包括：穿刺针、金属保护套和尾部标识物，所述的金属保护套可套装在穿刺针的针尖及部分针体上，尾部标识物安装在穿刺针的尾部；所述的穿刺针由形状记忆合金制成，包括针体和针尖两部分，所述穿刺针针尖一端预设一定的弯曲角度，所述的弯曲角度为30-90°，所述穿刺针针体靠近尾部的一端设有长度刻度，在使用时可以显示针体已进入人体的长度。
该用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置也可以称为多功能心脏间隔管状穿刺装置。
所述穿刺针的化学成分组成有两种：NiTi或NiTi-X合金，其中X为Nb、Cu、Fe和Ag等中选取的一种或多种元素。
优选的，NiTi合金中，Ni的原子比为48-52at％，其余为Ti。
优选的，NiTi-X合金中，Ti与Ni元素的原子比为(0.8:1.1)～(1.2:0.9)，X元素的原子百分数小于20％。
所述穿刺针在温度低于其合金的降温相变温度以下时，晶体结构为B19’相或B19相或R相，呈现柔软状态，弹性模量为20-60GPa，易于变形；在温度高于其合金的升温相变温度以上时，晶体结构转变为B2相，硬度增加，弹性模量为50-100GPa，穿刺针的针尖一端自动弯曲至预设的弯曲角度。所述穿刺针合金的降温相变温度为0-30℃范围内的某一温度，升温相变温度为15-35℃范围内的某一温度，具体的降温相变温度和升温相变温度因穿刺针合金成分的不同而不同。
优选的，所述穿刺针的弯曲部分包括针尖和部分针体，所述穿刺针的弯曲部分长度 为0.5-4cm。
优选的，所述穿刺针的预设弯曲角度为50-60°，弯曲部分长度为1-3cm。更优选的，所述穿刺针的针尖一端预设弯曲角度为60°，弯曲部分长度为2cm。
所述的穿刺针的针体为丝材，其横截面可为圆形、方形或多边形等，直径或穿过中心的对角线长为0.5-2mm。优选的，所述穿刺针的针体为圆形丝材，直径为1mm。
所述穿刺针也可以为管状穿刺针，所述管状穿刺针由镍钛基形状记忆合金制成，该针体为中空管状结构，于靠近针尖的针体某一处预置有一定弯曲角度的弯曲部分；当所述管状穿刺针进入心腔后，靠近针尖的针体某一处受热后，其硬度增加且能自动弯曲至所述弯曲角度。当采用管状穿刺针时，所述针体的横截面包括圆环或多边形环；优选地，该针体的横截面的外径或穿过该横截面中心的对角线长为0.2-3mm，其内径或穿过该横截面中心的对角线长为0.1-2.5mm。针尖的斜截面可以为椭圆环形，优选地，该斜截面与针体的夹角为10-60°。
本发明提供的装置还可以包括三通活塞，该三通活塞与所述管状穿刺针针体的尾部配合连接。三通活塞的材质可以为塑料。
所述的穿刺针的长度可以根据具体使用情况进行设置；优选的，所述穿刺针的长度为80-130cm。
所述的穿刺针的针尖为锥形，锥度为0.1-0.3。优选的，所述穿刺针的针尖形状为圆锥形，圆锥的锥度为0.2。
所述的金属保护套形状为中空管，外径为2-4mm，内径与穿刺针的针体外径相同，金属保护套的一端为圆台状，材质可以为不锈钢，铝、铜等，优选为不锈钢，用于保护针尖且辅助将穿刺针送进导管。优选的，所述金属保护套为金属材质的圆形管，外径为3mm，内腔的内径为1mm，一端为圆台状。
所述的尾部标识物(或称方向指示标)为塑料材质，组装在穿刺针尾部；设置尾部标识物的目的是为了确定针尖弯曲的方向，用于确定穿刺针的弯曲方向，便于进行控制和调整穿刺针在左心室内的方向与位置。另外为了操作方便，该标识物可以拆卸组装。
本发明还提供了上述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，该方法包括穿刺针的丝材制备、针尖制作、定型处理和表面处理工艺等。
一种用于经外周动脉进入左心室进行穿刺室间隔的穿刺针的制备方法，包括如下步骤：
(1)丝材制备：将所述的形状记忆合金进行拔丝处理，制备得到丝材；
(2)针尖制作：机械加工磨制针尖或腐蚀法制备针尖，得到锥形针尖；
(3)定型和时效处理：对穿刺针进行定型处理，将穿刺针针尖一端(包括针尖和部分针体)的弯曲角度定型为30-90°；然后对穿刺针或单独对穿刺针弯曲部分(针尖和部分针体部位)进行时效处理；
(4)表面处理：将定型处理后的穿刺针进行表面清洁处理。
当采用管材制备该用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置时，其制备方法可以包括如下步骤：
(1)选取镍钛基形状记忆合金管材，并于该管材的一端制作针尖；
(2)对步骤(1)已制作出针尖的管材进行定型处理，以将靠近针尖的针体端预制出具有一定弯曲角度的弯曲部分；
(3)对步骤(2)定型处理后所得管材或者对所述弯曲部分进行时效处理；
(4)再将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，即得到所述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置。
步骤(1)中，所述穿刺针的化学成分为NiTi或NiTi-X合金，其中X为Nb、Cu、Fe和Ag等中选取的一种或多种元素。所述的丝材的直径为0.5-2mm。
优选的，NiTi合金中，Ni的原子比为48-52at％，其余为Ti。
优选的，NiTi-X合金中，Ti与Ni元素的原子比为(0.8:1.1)～(1.2:0.9)，优选为(0.9:1)～(1.1:1)，X元素的原子百分数小于20％。
步骤(2)中，所得针尖的锥度为0.1-0.3。
步骤(3)中，穿刺针的弯曲部分长度优选为0.5-4cm。
对穿刺针进行定型处理时，针体与针尖加装定型装置，针体部位(大部分针体)的定型装置为直线型，针尖一端(针尖+部分针体)的定型装置为弯曲型，弯曲角度为30-90°，所述的定型处理温度为350-650℃，定型处理温度优选为400-650℃，更优选为450-600℃，定型处理时间为180-2分钟。定型处理后穿刺针形状如图2所示。一般情况下，定型温度越高所需定型时间越短，目的是为了制定穿刺针的形状。
对穿刺针进行定型处理后，需要再进行时效处理，时效处理的目的是为了调节穿刺针的相变温度(包括由软变硬的升温相变温度和由硬变软的降温相变温度)，时效处理包括两种方式：一种方式是针对穿刺针整体进行时效处理，时效温度为300-600℃(一般选用的时效温度略低于定型温度)，优选为300-550℃，更优选为400-500℃，时效时 间为360-5分钟，优选为180-10分钟，这种处理方法获得的穿刺针在低温下整体都是柔软的，进入人体后整体变硬，针尖自动弯曲至设定角度；另一种方式是只对穿刺针靠近针尖的一端，包括穿刺针弯曲部分(针尖和部分针体)和另一部分针体，约2-30cm进行时效处理，时效温度为300-600℃，优选为300-550℃，更优选为400-500℃，时效时间为360-5分钟，这种处理方法获得的穿刺针在低温下针尖一端的弯曲部分是柔软的，针体的大部分硬度较高，进入人体后，针体硬度变化不大，针尖一端自动弯曲至设定角度，且硬度提升。
本发明中，对穿刺针进行定型处理和时效处理两步处理，即将定型与相变温度调控分开进行，时效温度一般不高于定型温度，优选的，时效温度比定型温度低0-200℃，定型时间较短，时效时间较长；这样可以在更好、更准确地实现穿刺针的形状定型的同时，也更好地实现调节相变温度。
步骤(4)中，对针体表面进行酸洗清洁处理。
使用前，先将穿刺针置于降温相变温度以下，例如冰水混合物中，这时穿刺针处于B19’相或B19相或R相，呈现柔软状态，易于变形，将穿刺针人工矫直；进入心脏后，心脏内温度超过30℃，高于升温相变温度，针尖部位受温度作用自动弯曲至预置的弯曲角度，晶体结构转变为B2相，硬度增加。
根据本发明的具体实施方案，上述制备方法还可以包括：将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，即得到所述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置。
根据本发明的具体实施方案，上述制备方法还可以包括：将方向指示标安装于该管状穿刺针针体的尾部后，再将三通活塞与所述管状穿刺针针体的尾部进行配合连接，即得到所述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置。
根据本发明的具体实施方案，用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置(也可以称为：多功能心脏间隔管状穿刺装置)可以采用记忆合金丝材制备，也可以采用记忆合金管材制备，当采用管材制备时，具体技术方案如下：
本发明提供了一种多功能心脏间隔管状穿刺装置，其中，所述多功能心脏间隔管状穿刺装置包括：
管状穿刺针，所述管状穿刺针由镍钛基形状记忆合金制成，其包括针体和针尖，该针体为中空管状结构，于靠近针尖的针体某一处预置有一定弯曲角度的弯曲部分；
金属保护套，靠近针尖的部分针体和针尖套装于该金属保护套内；
方向指示标，其安装于该管状穿刺针针体的尾部，用于确定所述针尖弯曲的方向；
当所述管状穿刺针进入心腔后，靠近针尖的针体某一处受热后，其硬度增加且能自动弯曲至所述弯曲角度，以便于穿刺心脏间隔。
根据本发明具体实施方案，在所述的装置中，于靠近针尖的针体某一处预置有一定弯曲角度的弯曲部分，由此显而易见可知，该弯曲部分包括针尖及部分靠近针尖的针体；
另，本发明中，套装于该金属保护套内的靠近针尖的部分针体的长度应大于弯曲部分所包括的针体的长度。
根据本发明具体实施方案，在所述的装置中，优选地，所述弯曲角度为30-90°，更优选地，所述弯曲角度为45-60°。
根据本发明具体实施方案，在所述的装置中，优选地，所述弯曲部分的长度为0.5-6cm，更优选地，所述弯曲部分的长度为1-3cm，进一步优选地，所述弯曲部分的长度为2-3cm。
根据本发明具体实施方案，优选地，所述装置还包括三通活塞，该三通活塞与所述管状穿刺针针体的尾部配合连接。
根据本发明具体实施方案，在所述的装置中，优选地，所述三通活塞的材质为塑料。
根据本发明具体实施方案，在所述的装置中，优选地，所述方向指示标的材质也为塑料。
根据本发明具体实施方案，优选地，所述针体上设置有长度刻度，该长度刻度的起始刻度位于针体尾部。其中，本发明于针体上设置有长度刻度标识，在使用时可以显示针体已进入人体的长度。
其中，本发明该装置设置方向指示标(尾部标识物)的目的是为了确定针尖弯曲的方向，用于确定管状穿刺针的弯曲方向(手术过程中，借助成像设备实时成像，可以观察到针尖部位的弯曲方向)，便于进行控制和调整管状穿刺针在右心房或左心室内的方向与位置；
设置三通活塞的目的是为了便于心腔测压及通过穿刺针手推造影剂定位。
根据本发明具体实施方案，在所述的装置中，优选地，在管状穿刺针所处环境温度低于镍钛基形状记忆合金的马氏体相变温度范围的上限温度时，所述由镍钛基形状记忆合金制成的管状穿刺针中，至少所述弯曲部分呈现柔软状态，易于变形；在管状穿刺针所处环境温度高于镍钛基形状记忆合金的奥氏体相变温度范围的下限温度时，所述由镍钛基形状记忆合金制成的管状穿刺针中，至少所述弯曲部分的硬度增加，且该弯曲部分 能自动弯曲至所述弯曲角度；
其中，镍钛基形状记忆合金的马氏体相变温度范围为0-30℃，其奥氏体相变温度范围为15-35℃。
本发明中，在管状穿刺针所处的环境温度低于其合金的马氏体相变温度范围的上限温度时，晶体结构为B19’相或B19相或R相，至少所述弯曲部分呈现柔软状态，弹性模量为20-60GPa，易于变形；在其所处环境温度高于其合金的奥氏体相变温度范围的下限温度时，晶体结构转变为B2相，硬度增加，弹性模量为50-100GPa，至少所述弯曲部分的硬度增加，且该弯曲部分能自动弯曲至所述弯曲角度。具体地，马氏体相变温度范围和奥氏体相变温度范围因管状穿刺针合金成分的不同而不同。
根据本发明具体实施方案，在所述的装置中，优选地，所述镍钛基形状记忆合金包括NiTi合金或NiTi-X合金；其中，X为选自Nb、Cu、Fe和Ag中的一种元素或多种元素的组合；
更优选地，NiTi合金中，Ni的原子比为48-52at％，其余为Ti；
还更优选地，NiTi-X合金中，Ti元素与Ni元素的原子比为0.8:1.1-1.2:0.9，X元素的原子百分数小于20％。
根据本发明具体实施方案，在所述的装置中，优选地，所述针体的横截面包括圆环或多边形环；
更优选地，该针体的横截面的外径或穿过该横截面中心的对角线长为0.2-3mm，其内径或穿过该横截面中心的对角线长为0.1-2.5mm；
进一步优选地，所述针体的横截面为圆环，该圆环的外径为1-3mm，内径为0.5-2mm。
根据本发明具体实施方案，在所述的装置中，优选地，所述针尖的斜截面为椭圆环形，该斜截面与针体的夹角为10-60°；
更优选地，该斜截面与针体的夹角为30-45°。
根据本发明具体实施方案，在所述的装置中，优选地，所述金属保护套为中空管，其外径为2-4mm，内径与所述针体外径相同，该金属保护套的尾端(背离金属保护套开口方向的一端为尾端)为圆台状，其材质包括不锈钢、铝、铜；
更优选地，所述金属保护套为不锈钢材质的圆形管，其外径为2-3mm，内腔的内径为1-2mm。
其中，该金属保护套用于保护针尖且可辅助(便于)将管状穿刺针送入鞘管。
根据本发明具体实施方案，在所述的装置中，所述的管状穿刺针的长度可以根据具 体使用情况进行设置，优选地，所述管状穿刺针的长度为80-130cm。
另一方面，本发明还提供了所述的多功能心脏间隔管状穿刺装置的制作方法，其中，所述制作方法包括以下步骤：
(1)选取镍钛基形状记忆合金管材，并于该管材的一端制作针尖；
(2)对步骤(1)已制作出针尖的管材进行定型处理，以将靠近针尖的针体端预置出具有一定弯曲角度的弯曲部分；
(3)对步骤(2)定型处理后所得管材或者对所述弯曲部分进行时效处理；
(4)再将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，即得到所述的多功能心脏间隔管状穿刺装置。
根据本发明具体实施方案，在所述的制作方法中，优选地，步骤(1)中采用机械加工磨制针尖或采用腐蚀法制作针尖。
根据本发明具体实施方案，在所述的制作方法中，优选地，步骤(2)中，所述定型处理温度为350-650℃，定型处理时间为180-2分钟；更优选地，所述定型处理温度为400-650℃，进一步优选地，所述定型处理温度为450-600℃。一般情况下，定型温度越高所需定型时间越短。
根据本发明具体实施方案，在所述的制作方法步骤(2)中，所述定型处理的目的是为了制定管状穿刺针的形状，该定型处理可以按照以下步骤进行：
将步骤(1)已制作出针尖的管材加装定型装置(本领域使用的常规装置)，其中，弯曲部分的定型装置为具有特定弯曲角度的弯曲型定型装置，弯曲部分之外所用的定型装置为直线型定型装置。
根据本发明具体实施方案，在所述的制作方法中，优选地，步骤(3)中，所述时效处理的温度不高于所述定型处理温度，所述时效处理时间为360-5分钟；更优选地，所述时效处理的温度比定型处理温度低0-200℃；进一步优选地，所述时效处理的温度为300-600℃。
根据本发明具体实施方案，在所述的制作方法步骤(3)中，所述时效处理的目的是为了调节管状穿刺针的相变温度(包括由软变硬的奥氏体相变温度和由硬变软的马氏体相变温度)，该时效处理过程包括两种方式：一种方式是针对管状穿刺针整体(定型处理后所得管材)进行时效处理，时效处理温度为300-600℃(一般选用的时效处理温度略低于定型温度，如时效处理的温度比定型处理温度低0-200℃)，优选为300-550℃，更优选为400-500℃，时效处理时间为360-5分钟，优选为180-10分钟；该种处理方式 获得的管状穿刺针在低温下整体都是柔软的，进入人体后整体变硬，针尖部分自动弯曲至设定角度；另一种方式是只对管状穿刺针靠近针尖的一端，包括管状穿刺针弯曲部分(针尖和部分针体)和另一部分针体，共约2-30cm进行时效处理，时效温度为300-600℃，优选为300-550℃，更优选为400-500℃，时效处理时间为360-5分钟，该种处理方法获得的管状穿刺针在低温下针尖一端的弯曲部分是柔软的，针体的大部分硬度较高，进入人体后，针体硬度变化不大，针尖一端自动弯曲至设定角度，且硬度提升。
在本发明所述的制作方法中，对管状穿刺针依次进行了定型处理和时效处理两步处理，即将定型与相变温度调控分开依次进行，且时效处理温度一般不高于定型处理温度，优选地，时效处理温度比定型处理温度低0-200℃，定型处理时间较短，时效处理时间较长；这样可以在更好、更准确地实现管状穿刺针的形状定型的同时，也更好地实现对相变温度进行调节。
根据本发明具体实施方案，所述的制作方法还包括对步骤(3)时效处理后所得产品进行表面清洁处理后，其中，所述表面清洁处理为对表面进行酸洗清洁处理。
根据本发明具体实施方案，优选地，该制作方法还包括：将方向指示标安装于该管状穿刺针针体的尾部后，再将三通活塞与所述管状穿刺针针体的尾部进行配合连接，即得到所述的多功能心脏间隔管状穿刺装置。
又一方面，本发明还提供了所述的多功能心脏间隔管状穿刺装置作为用于经下腔静脉进入右心房穿刺房间隔或经外周动脉进入左心室穿刺室间隔的穿刺装置的应用。
根据本发明具体实施方案，在所述的应用中，优选地，应用前，将管状穿刺针所处环境温度设置为低于镍钛基形状记忆合金的马氏体相变温度范围的上限温度后，对该管状穿刺针进行人工矫直再进行穿刺。
其中，应用前，可将管状穿刺针所处环境温度设置为低于镍钛基形状记忆合金的马氏体相变温度范围的上限温度(如可将该管状穿刺针置于冰水混合物中)，该管状穿刺针处于B19’相或B19相或R相，呈现柔软状态，易于变形，此时可对该管状穿刺针进行人工矫直；管状穿刺针进入心脏后，心脏内温度超过30℃，其高于镍钛基形状记忆合金的奥氏体相变温度范围的下限温度，针尖部位受温度作用自动弯曲至预置的弯曲角度，晶体结构转变为B2相，硬度增加。
本发明中，当穿刺针置于体外冰水混合物中时，呈现柔软状态，易于变形，便于经外周动脉进入左心室。当穿刺针进入左心室后针尖部位自动弯曲至预先设置角度且硬度显著增加。
应用过程中，通过中空管腔还能够辅助实现造影定位及监测心脏内部压力的功能。
本发明的室间隔穿刺针具有特殊的温度控制下的变形和伴随的硬度改变特征(即可体温自行改变硬度和弯曲角度)，能够为心脏间隔穿刺提供极佳的进针角度，有效完成室间隔穿刺任务；本发明的穿刺针远段预设角度多样，可以完成不同的房间隔及室间隔穿刺任务；管状穿刺针通过中空管腔还能够辅助实现造影定位及监测心脏内部压力的功能。另外，本发明涉及的穿刺针通过物理穿刺的方法，对室间隔和穿刺周围组织附带损伤小，带来的潜在危害大幅降低，其安全性优于现有技术中的三种方法，且可多次尝试心脏间隔穿刺。
本发明的穿刺针可以通过外围动脉，主要但不限于股动脉，可以从动脉完成室间隔穿刺，避免了现有技术中三种方法仅能够从静脉穿刺的弊端。并且，本发明的穿刺针针体细小，操作安全，可多次尝试室间隔穿刺。
附图说明
图1为本发明的穿刺针装置示意图。
图2为本发明的穿刺针加热后预设弯度示意图。
图3为本发明的穿刺针在体外冰水温度下人为矫直后的实物图。
图4为本发明的穿刺针在约35℃温度下自动弯折的实物图。
图5为本发明所提供的管状穿刺装置的结构示意图。
图6为本发明具体实施例中的管状穿刺针加热后预设弯度示意图。
主要附图标记说明：
1    尾部标识物(方向指示标)    2   穿刺针
3    金属保护套                4   三通活塞
具体实施方式
下面将结合附图和实施例，对用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置及制备方法作进一步说明。
一、采用形状记忆合金丝材制成的穿刺针装置：
如图1所示，本发明的穿刺针装置包括：穿刺针2、金属保护套3和尾部标识物(或称方向指示标)1。穿刺针2由形状记忆合金制成，包括针体和针尖两部分，穿刺针针尖一端预置一定的弯曲角度，弯曲角度为30-90°；靠近针体尾部的一端具有刻度标示(标识穿刺针2的长度)，在使用时可以显示针体已进入人体的长度；金属保护套3套装在穿刺针2的针尖及部分针体上，金属保护套3保护针尖且辅助将穿刺针2送进导管，形 状为中空管，一端为圆台状。尾部标识物1安装在穿刺针2的尾部，使用时露在体外，尾部标识物1用来确定针尖弯曲方向及控制调整针尖在左心室内方向与位置。
穿刺针2的化学成分组成：1)NiTi合金，原子比Ti-48-52at％Ni；或者，2)NiTi-X合金，Ti：Ni元素的原子比为(0.8:1.1)～(1.2:0.9)，优选为(0.9:1)～(1.1:1)，X元素的原子百分数小于20％。
穿刺针2针体形状特征：丝材(横截面可为圆形、方形、多边形)，直径：0.5-2mm。
穿刺针2针尖形状特征：锥形；预设的弯曲角度即进入心脏后的弯曲角度范围为30-90°，如图2所示；弯曲部分长度范围0.5-4cm。
NiTi或NiTi-X合金因成分不同，其相变温度也不同；NiTi或NiTi-X合金的降温相变在0-30℃范围内任一温度，穿刺针变软；在升温至20-35℃范围内任一温度，发生相变，穿刺针变硬，且针尖部位弯曲至预设角度。如穿刺针2在体外温度低于20℃时，晶体结构为B19’相或B19相或R相，呈现柔软状态，易于变形；当穿刺针进入心脏后，针尖部位自动弯曲至预置的弯曲角度，晶体结构转变为B2相，硬度增加。
穿刺针2制备工艺包括：丝材制备-针尖制作-定型处理-表面处理。首先拔丝制备直径0.5-2mm的丝材，然后磨制针尖或腐蚀法制备针尖，定型处理(温度400-650℃)和时效处理，最后对针体表面酸洗清洁处理。
(1)定型处理：针体与针尖加装定型装置，针体部位的定型装置为直线型，针尖部位的定型装置为弯曲型，弯曲角度为30-90°，定型温度400-650℃，定型时间180-2分钟，定型处理后穿刺针形状如图2所示。
(2)时效处理：时效处理的目的是为了调节穿刺针的相变温度(由硬变软和由软变硬的温度)，一种办法是穿刺针整体进行时效处理，时效温度为300-600℃，时效时间为360-5分钟，这种处理方法获得的穿刺针在低温下整体都是柔软，进入人体后整体变硬，针尖自动弯曲至设定角度；另一种办法是只对穿刺针靠近针尖一端的部位(2-30cm)进行时效处理时效温度为300-600℃，时效时间为360-5分钟，时效温度一般略低于定型温度，这种处理方法获得的穿刺针在低温下针尖附件部位柔软，针体部位硬度较高，进入人体后，针体硬度变化不大，针尖部位自动弯曲至设定角度，硬度提升。
实施例一：
制备化学成分为NiTi(Ti-51at％Ni)合金的穿刺针：(1)熔炼NiTi合金铸锭，经锻造、拔丝加工成直径1mm、截面为圆形的丝材，截取合适长度的丝材实施进一步处理；(2)机械加工磨制锥度为0.2的针尖(针尖长度为0.5cm)；(3)定型处理，首先在针 尖部位加装定型装置，预设针尖一端的弯曲角度为60°和长度为2cm，随后将穿刺针置于定型处理炉，定型温度500℃，定型时间10分钟，最后对针尖一端的弯曲部位进行时效处理，时效温度为450℃，时效时间为30分钟；(4)进行表面酸洗清洁处理；(5)功能测试：将穿刺针置于冰水混合物中时，针尖呈现柔软，进行校直(如图3所示)，随后模拟心脏内温度，将穿刺针置于约35℃温水中，针尖受热自动弯曲成为预设置角度，且针尖硬度增加(如图4所示)。
金属保护套为金属材质的圆形管，外径为3mm，内腔的内径为1mm，一端为圆台状。金属保护套的一端为圆台状，材质为不锈钢，用于保护针尖且辅助将穿刺针送进导管。
尾部标识物为塑料材质，可以拆卸组装在穿刺针尾部；用于确定穿刺针的弯曲方向，便于进行控制和调整穿刺针在左心室内的方向与位置。
实施例二：
制备化学成分为NiTiNb(Ti：Ni元素的原子比为0.9:1，Nb元素的原子百分数为10％)的穿刺针：(1)熔炼NiTiNb合金铸锭，经锻造、拔丝加工成直径1mm、截面为圆形的丝材，截取合适长度的丝材实施进一步处理；(2)机械加工磨制锥度为0.2的针尖；(3)定型处理，首先在针尖部位加装定型装置，预设针尖弯曲角度50°和长度2cm，随后将穿刺针置于定型处理炉，定型温度530℃，定型时间15分钟，最后对针尖一端的弯曲部位进行时效处理，时效温度为400℃，时效时间为60分钟；(4)进行表面酸洗清洁处理；(5)功能测试：将穿刺针置于冰水混合物中时，针尖呈现柔软，进行校直，随后模拟心脏内温度，将穿刺针置于约35℃温水中，针尖受热自动弯曲成为预设置角度，且针尖硬度增加。
金属保护套为金属材质的圆形管，外径为3mm，内腔的内径为1mm，一端为圆台状。金属保护套的一端为圆台状，材质可以为不锈钢，用于保护针尖且辅助将穿刺针送进导管。
尾部标识物为塑料材质，可以拆卸组装在穿刺针尾部；用于确定穿刺针的弯曲方向，便于进行控制和调整穿刺针在左心室内的方向与位置。
使用时，首先穿刺针针尖置于体外低于降温相变温度，如低于20℃环境下，将穿刺针针尖部位人工矫直；再通过金属保护套辅助穿刺针被送入置于外周动脉的导管，穿过导管的中空腔，在导管引导作用下穿刺针进入患者左心室，此时穿刺针受人体温度(即温度高于30℃时)影响自动弯曲至预设置角度，即弯曲角度范围30-90°，弯曲部分长度 范围0.5-4cm；再操作穿刺针尾部装置实现调整穿刺针的方向与位置来寻找合适的穿刺角度与位置，然后用力推送穿刺针，针尖穿过室间隔后，将导管沿穿刺针送入右心室，随后撤出穿刺针，穿刺室间隔操作完成。
本发明的穿刺针通过物理穿刺的方法，对室间隔和穿刺周围组织附带损伤小，带来的潜在危害大幅降低，其安全性好。并且，本发明的穿刺针针体细小，操作安全，可多次尝试室间隔穿刺。
二、采用镍钛基形状记忆合金管材制成的穿刺针装置：
图5为本发明所提供的该多功能心脏间隔管状穿刺装置的结构示意图，该装置包括：
管状穿刺针2，所述管状穿刺针2由镍钛基形状记忆合金制成，其包括针体和针尖，该针体为中空管状结构，于靠近针尖的针体某一处预置有一定弯曲角度的弯曲部分；
金属保护套3，靠近针尖的部分针体和针尖套装于该金属保护套内；金属保护套3用于保护针尖且辅助将管状穿刺针2送进鞘管；
方向指示标(或称尾部标识物)1，其安装于该管状穿刺针针体的尾部，使用时其露于体外，用于确定所述针尖弯曲的方向，便于进行控制和调整管状穿刺针在右心房或左心室内的方向与位置；
当所述管状穿刺针进入心腔后，靠近针尖的针体某一处受热后，其硬度增加且能自动弯曲至所述弯曲角度，以便于穿刺心脏间隔。
在一实施例中，所述弯曲角度为30-90°。
在一实施例中，所述弯曲部分的长度为0.5-6cm。
在一实施例中，所述装置还包括三通活塞，该三通活塞的材质为塑料。
在一实施例中，所述方向指示标的材质也为塑料。
在一实施例中，所述镍钛基形状记忆合金包括NiTi合金或NiTi-X合金；其中，X为选自Nb、Cu、Fe和Ag中的一种元素或多种元素的组合；
NiTi合金中，Ni的原子比为48-52at％，其余为Ti；
NiTi-X合金中，Ti元素与Ni元素的原子比为0.8:1.1-1.2:0.9，X元素的原子百分数小于20％。
NiTi合金或NiTi-X合金因成分不同，其相变温度也不同；NiTi合金或NiTi-X合金的马氏体相变温度为0-30℃，当该管状穿刺针所处环境温度为0-30℃范围内任一温度时，管状穿刺针变软；其所处环境温度升温至20-35℃范围内任一温度时，发生奥氏体相变，管状穿刺针变硬，且针尖部位弯曲至预设角度。如管状穿刺针2在体外温度低于 20℃时，晶体结构为B19’相或B19相或R相，呈现柔软状态，易于变形；当管状穿刺针进入心脏后，针尖部位受热后自动弯曲至预置的弯曲角度，晶体结构转变为B2相，硬度增加。
在一实施例中，所述针体的横截面包括圆环或多边形环；该针体的横截面的外径或穿过该横截面中心的对角线长为0.2-3mm，其内径或穿过该横截面中心的对角线长为0.1-2.5mm。
在一实施例中，所述针尖的斜截面为椭圆环形，该斜截面与针体的夹角为10-60°。
在一实施例中，所述金属保护套为中空管，其外径为2-4mm，内径与所述针体外径相同，该金属保护套的尾端为圆台状，其材质包括不锈钢、铝、铜。
在一实施例中，所述管状穿刺针的长度为80-130cm。
在一实施例中，所述针体上设置有长度刻度，该长度刻度的起始刻度位于针体尾部。
在一实施例中，所述装置还包括三通活塞4，该三通活塞4与所述管状穿刺针2针体的尾部配合连接。
本发明所提供的该多功能心脏间隔管状穿刺装置的制作方法包括以下步骤：
(1)选取镍钛基形状记忆合金管材，并于该管材的一端制作针尖；
(2)对步骤(1)已制作出针尖的管材进行定型处理，以将靠近针尖的针体端预制出具有一定弯曲角度的弯曲部分；
(3)对步骤(2)定型处理后所得管材或者对所述弯曲部分进行时效处理；
还优选地，所述时效处理的温度不高于所述定型处理温度，所述时效处理时间为360-5分钟；还更优选地，所述时效处理的温度比定型处理温度低0-200℃；还进一步优选地，所述时效处理的温度为300-600℃；
(4)将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，再将三通活塞与所述管状穿刺针针体的尾部进行配合连接，即得到所述的多功能心脏间隔管状穿刺装置。
在一实施例中，步骤(1)中可采用机械加工磨制针尖或采用腐蚀法制作针尖。
在一实施例中，步骤(2)中，所述定型处理的目的是为了制定管状穿刺针的形状，该定型处理可以按照以下步骤进行：
将步骤(1)已制作出针尖的管材加装定型装置(本领域使用的常规装置)，其中，弯曲部分的定型装置为具有特定弯曲角度的弯曲型定型装置，弯曲部分之外所用的定型装置为直线型定型装置；
所述定型处理温度为350-650℃，定型处理时间为180-2分钟；定型处理后管状穿刺针形状如图6所示。
在一实施例中，步骤(3)中，所述时效处理的目的是为了调节管状穿刺针的相变温度(包括由软变硬的奥氏体相变温度和由硬变软的马氏体相变温度)，该时效处理过程包括两种方式：一种方式是针对管状穿刺针整体(定型处理后所得管材)进行时效处理，时效处理温度为300-600℃，时效处理时间为360-5分钟；该种处理方式获得的管状穿刺针在低温下整体都是柔软的，进入人体后整体变硬，针尖部分自动弯曲至设定角度；另一种方式是只对管状穿刺针靠近针尖的一端，包括管状穿刺针弯曲部分(针尖和部分针体)和另一部分针体(弯曲部分及另一部分针体的长度共约2-30cm)进行时效处理，时效处理温度为300-600℃，时效处理时间为360-5分钟，时效处理温度一般略低于定型处理温度，该种处理方法获得的管状穿刺针在低温下针尖一端的弯曲部分是柔软的，针体的大部分硬度较高，进入人体后，针体硬度变化不大，针尖一端自动弯曲至设定角度，且硬度提升。
在一实施例中，该方法还包括对步骤(3)时效处理后所得产品进行表面酸洗清洁处理。
下面给出一些具体实施例，说明本发明所提供的该多功能心脏间隔管状穿刺装置及其制作方法与应用。
实施例三
本实施例提供了一种多功能心脏间隔管状穿刺装置，其中，该多功能心脏间隔管状穿刺装置包括：
管状穿刺针，所述管状穿刺针由NiTi(Ti的原子比为51at％，Ni的原子比为49at％)合金制成，其包括针体和针尖，该针体为中空圆形管状结构(外径为1.2mm，内径为0.8mm)，于靠近针尖的针体某一处预置有60°的弯曲部分(长度为2cm)，其中，该弯曲部分包括针尖(其长度为0.5cm)及一部分针体；
所述针尖的斜截面为椭圆环形，该斜截面与针体的夹角为30°；
金属保护套，靠近针尖的部分针体和针尖套装于该金属保护套内；所述金属保护套为不锈钢材质的中空圆管，其外径为3mm，内径与所述针体外径相同，为1.2mm，该金属保护套的尾端为圆台状；
方向指示标，可以拆卸组装在管状穿刺针针体的尾部，为塑料材质，使用时其露于体外，用于确定所述针尖弯曲的方向，便于进行控制和调整管状穿刺针在右心房或左心 室内的方向与位置；
三通活塞，该三通活塞与所述管状穿刺针针体的尾部配合连接；
本实施例所用的NiTi合金的马氏体相变温度为0-30℃，当该管状穿刺针所处环境温度为0-30℃范围内任一温度时，管状穿刺针针尖部位变软；其所处环境温度升温至15-35℃范围内任一温度时，发生奥氏体相变，管状穿刺针针尖部位变硬，且针尖部位弯曲至预设角度(即60°)。
本实施例所提供的该多功能心脏间隔管状穿刺装置的制作方法包括以下步骤：
制作材质为NiTi(Ti-51at％Ni)合金的管状穿刺针：
(1)选取NiTi管材，其为外径1.2mm，内径0.8mm的圆形管材，截取合适长度的管材；
(2)机械加工斜截面与针体夹角为30°的针尖(针尖长度为0.5cm)；
(3)对步骤(2)已制作出针尖的管材进行定型处理，以将靠近针尖的针体端预制出具有一定弯曲角度的弯曲部分，具体为：将步骤(2)已制作出针尖的管材加装定型装置(本领域使用的常规装置)，其中，弯曲部分的定型装置为具有60°弯曲角度的弯曲型定型装置，弯曲部分之外所用的定型装置为直线型定型装置；随后将管状穿刺针置于定型处理炉进行处理，定型温度为500℃，定型时间为10分钟；
对管状穿刺针靠近针尖的一端，包括管状穿刺针弯曲部分(针尖和部分针体)和另一部分针体(弯曲部分及另一部分针体的长度共约2-30cm)进行时效处理，时效处理的温度为450℃，时效时间为30分钟；
(4)步骤(3)时效处理后所得产品进行表面酸洗清洁处理，得到材质为NiTi(Ti-51at％Ni)合金的管状穿刺针；
将本实施例制作得到的管状穿刺针置于冰水混合物中时，针尖呈现柔软状态，进行校直，随后模拟心脏内温度，将管状穿刺针置于约35℃温水中，针尖受热自动弯曲成为预设置角度(60°)，且针尖硬度增加。
将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，再将三通活塞与所述管状穿刺针针体的尾部进行配合连接，即得到所述的多功能心脏间隔管状穿刺装置。
实施例四
本实施例提供了一种多功能心脏间隔管状穿刺装置，其中，该多功能心脏间隔管状穿刺装置包括：
管状穿刺针，所述管状穿刺针由NiTiNb合金(Ti、Ni元素的原子比为0.9:1，Nb元素的原子百分数为10％)制成，其包括针体和针尖，该针体为中空圆形管状结构(外径为1mm，内径为0.6mm)，于靠近针尖的针体某一处预置有50°的弯曲部分(长度为2cm)，其中，该弯曲部分包括针尖(其长度为0.3cm)及一部分针体；
所述针尖的斜截面为椭圆环形，该斜截面与针体的夹角为20°；
金属保护套，靠近针尖的部分针体和针尖套装于该金属保护套内；所述金属保护套为不锈钢材质的中空圆管，其外径为3mm，内径与所述针体外径相同，为1cm，该金属保护套的尾端为圆台状；
方向指示标，可以拆卸组装在管状穿刺针针体的尾部，为塑料材质，使用时其露于体外，用于确定所述针尖弯曲的方向，便于进行控制和调整管状穿刺针在右心房或左心室内的方向与位置；
三通活塞，该三通活塞与所述管状穿刺针针体的尾部配合连接；
本实施例所用的NiTi合金的马氏体相变温度为0-30℃，当该管状穿刺针所处环境温度为0-30℃范围内任一温度时，管状穿刺针变软；其所处环境温度升温至15-35℃范围内任一温度时，发生奥氏体相变，管状穿刺针变硬，且针尖部位弯曲至预设角度(即60°)。
本实施例所提供的该多功能心脏间隔管状穿刺装置的制作方法包括以下步骤：
制作材质为NiTiNb合金(Ti、Ni元素的原子比为0.9:1，Nb元素的原子百分数为10％)的管状穿刺针：
(1)选取NiTiNb合金管材，其为外径1mm，内径0.6mm的圆形管材，截取合适长度的管材；
(2)机械加工斜截面与针体夹角为20°的针尖(针尖长度为0.3cm)；
(3)对步骤(2)已制作出针尖的管材进行定型处理，以将靠近针尖的针体端预制出具有一定弯曲角度的弯曲部分，具体为：将步骤(2)已制作出针尖的管材加装定型装置(本领域使用的常规装置)，其中，弯曲部分的定型装置为具有50°弯曲角度的弯曲型定型装置，弯曲部分之外所用的定型装置为直线型定型装置；随后将管状穿刺针置于定型处理炉进行处理，定型温度为530℃，定型时间为15分钟；
对管状穿刺针靠近针尖的一端，包括管状穿刺针弯曲部分(针尖和部分针体)和另一部分针体(弯曲部分及另一部分针体的长度共约2-30cm)进行时效处理，时效处理温度为400℃，时效时间为60分钟；
(4)步骤(3)时效处理后所得产品进行表面酸洗清洁处理，得到材质为NiTi(Ti-51at％Ni)合金的管状穿刺针；
将本实施例制作得到的管状穿刺针置于冰水混合物中时，针尖呈现柔软状态，进行校直，随后模拟心脏内温度，将管状穿刺针置于约35℃温水中，针尖受热自动弯曲成为预设置角度(50°)，且针尖硬度增加。
将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，再将三通活塞与所述管状穿刺针针体的尾部进行配合连接，即得到所述的多功能心脏间隔管状穿刺装置。
使用本发明所提供的该多功能心脏间隔管状穿刺装置时，首先将管状穿刺针针尖置于体外低于镍钛基形状记忆合金马氏体相变温度的上限温度的环境下，如低于20℃环境下，将管状穿刺针针尖部位进行人工矫直；再通过金属保护套辅助将管状穿刺针送入置于外周动脉的或下腔静脉的导管，穿过导管的中空腔，在导管引导作用下管状穿刺针进入患者右心房或左心室，此时管状穿刺针受人体温度(即温度高于30℃时)影响自动弯曲至预设置角度，即弯曲角度范围30-90°，弯曲部分长度范围0.5-6cm；再操作管状穿刺针尾部装置实现调整管状穿刺针的方向与位置来寻找合适的穿刺角度与位置，此时可通过穿刺装置的内腔造影进行辅助定位并监测心腔压力；然后用力推送管状穿刺针，针尖穿过房间隔或室间隔后，将导管沿管状穿刺针送入左心房或右心室，随后撤出管状穿刺针，穿刺房间隔或室间隔操作完成。
以上实施例仅用以说明而非限制本发明的技术方案，尽管上述实施例对本发明进行了详细说明，本领域的相关技术人员应当理解：可以对本发明进行修改或者同等替换，但不脱离本发明精神和范围的任何修改和局部替换均应涵盖在本发明的权利要求范围内。

Claims (22)

  1. 一种用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：该穿刺针装置包括穿刺针、金属保护套和尾部标识物，所述的金属保护套可套装在穿刺针的针尖及部分针体上，尾部标识物安装在穿刺针的尾部；所述的穿刺针由形状记忆合金制成，包括针体和针尖两部分，所述穿刺针针尖一端预设一定的弯曲角度，所述的弯曲角度为30-90°，所述穿刺针针体靠近尾部的一端设有长度刻度。
  2. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述穿刺针的化学成分组成为NiTi或NiTi-X合金，其中X为Nb、Cu、Fe和Ag中选取的一种或多种元素。
  3. 根据权利要求2所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：NiTi合金中，Ni的原子比为48-52at％，其余为Ti；NiTi-X合金中，Ti与Ni元素的原子比为0.8:1.1～1.2:0.9，X元素的原子百分数小于20％。
  4. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述的穿刺针在温度低于其降温相变温度以下时，呈现柔软状态，易于变形；在温度高于其升温相变温度以上时，硬度增加，穿刺针的针尖一端自动弯曲至预设的弯曲角度；所述穿刺针的降温相变温度为0-30℃内的某一温度，升温相变温度为15-35℃内的某一温度。
  5. 根据权利要求4所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述的穿刺针在温度低于其降温相变温度以下时，晶体结构为B19’相或B19相或R相。
  6. 根据权利要求4所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述的穿刺针在温度高于其升温相变温度以上时，晶体结构转变为B2相。
  7. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述穿刺针的弯曲部分长度为0.5-4cm；所述穿刺针的针尖预置弯曲角度为50-60°。
  8. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述的穿刺针的针体为丝材，其横截面为圆形、方形或多边形，直径或穿过中心的对角线长为0.5-2mm；所述的穿刺针的针尖为锥形，锥度为0.1-0.3。
  9. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：
    所述穿刺针为管状穿刺针，所述管状穿刺针由镍钛基形状记忆合金制成，该针体为中空管状结构，于靠近针尖的针体某一处预置有一定弯曲角度的弯曲部分；
    当所述管状穿刺针进入心腔后，靠近针尖的针体某一处受热后，其硬度增加且能自动弯曲至所述弯曲角度。
  10. 根据权利要求9所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：
    所述针体的横截面包括圆环或多边形环；
    该针体的横截面的外径或穿过该横截面中心的对角线长为0.2-3mm，其内径或穿过该横截面中心的对角线长为0.1-2.5mm。
  11. 根据权利要求9所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：
    所述针尖的斜截面为椭圆环形，该斜截面与针体的夹角为10-60°。
  12. 根据权利要求9所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：
    所述装置还包括三通活塞，该三通活塞与所述管状穿刺针针体的尾部配合连接。
  13. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述的金属保护套形状为中空管，外径为2-4mm，内径与穿刺针的针体外径相同，金属保护套的一端为圆台状。
  14. 根据权利要求1所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置，其中：所述的尾部标识物为塑料材质，组装在穿刺针尾部。
  15. 根据权利要求1-14中任一项所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，包括如下步骤：
    (1)丝材制备：将所述的形状记忆合金进行拔丝处理，制备得到丝材；
    (2)针尖制作：机械加工磨制针尖或腐蚀法制备针尖，得到锥形针尖；
    (3)定型处理和时效处理：对穿刺针进行定型处理，将穿刺针针尖一端的弯曲角度定型为30-90°；然后对穿刺针或穿刺针弯曲部分进行时效处理；
    (4)表面处理：将定型处理后的穿刺针进行表面清洁处理；
    或者，
    (1)选取镍钛基形状记忆合金管材，并于该管材的一端制作针尖；
    (2)对步骤(1)已制作出针尖的管材进行定型处理，以将靠近针尖的针体端预制 出具有一定弯曲角度的弯曲部分；
    (3)对步骤(2)定型处理后所得管材或者对所述弯曲部分进行时效处理；
    (4)再将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，即得到所述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置。
  16. 根据权利要求15所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：所述的定型处理温度为350-650℃，处理时间为180-2分钟；时效处理温度为300-600℃，时效时间为360-5分钟，所述时效处理温度不高于定型处理温度。
  17. 根据权利要求16所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：所述的定型处理温度为400-650℃。
  18. 根据权利要求16所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：所述时效处理温度为300-550℃。
  19. 根据权利要求15所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：所述时效处理是针对穿刺针整体进行时效处理，时效温度为300-600℃，时效时间为360-5分钟。
  20. 根据权利要求15所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：
    所述时效处理是只对穿刺针靠近针尖的一端2-30cm进行时效处理，时效温度为300-600℃，时效时间为360-5分钟。
  21. 根据权利要求15所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：
    该制备方法还包括：将靠近针尖的部分针体和针尖套装于金属保护套内，并将方向指示标安装于该管状穿刺针针体的尾部，即得到所述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置。
  22. 根据权利要求15所述的用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置的制备方法，其中：
    该制作方法还包括：将方向指示标安装于该管状穿刺针针体的尾部后，再将三通活塞与所述管状穿刺针针体的尾部进行配合连接，即得到所述用于经外周动脉进入左心室进行穿刺室间隔的穿刺针装置。
PCT/CN2020/075647 2019-04-08 2020-02-18 用于经外周动脉进入左心室穿刺室间隔的穿刺针装置及制备方法 WO2020207118A1 (zh)

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EP2719425A1 (fr) * 2012-10-12 2014-04-16 Sorin CRM SAS Sonde de stimulation cardiaque implantable le long de la paroi du septum interventriculaire et/ou de la paroi libre du ventricule gauche
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