CN114788919A - Aneurysm interventional operation micro-catheter shaping auxiliary die and manufacturing method thereof - Google Patents
Aneurysm interventional operation micro-catheter shaping auxiliary die and manufacturing method thereof Download PDFInfo
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- 206010002329 Aneurysm Diseases 0.000 title claims abstract description 83
- 238000007493 shaping process Methods 0.000 title claims abstract description 60
- 238000004519 manufacturing process Methods 0.000 title abstract description 9
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- 238000000034 method Methods 0.000 claims description 22
- 210000004204 blood vessel Anatomy 0.000 claims description 21
- 238000010438 heat treatment Methods 0.000 claims description 21
- 238000007639 printing Methods 0.000 claims description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
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- 238000005452 bending Methods 0.000 claims description 15
- 238000013178 mathematical model Methods 0.000 claims description 13
- 238000012545 processing Methods 0.000 claims description 13
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 10
- 239000011347 resin Substances 0.000 claims description 9
- 229920005989 resin Polymers 0.000 claims description 9
- 238000011282 treatment Methods 0.000 claims description 9
- 238000010146 3D printing Methods 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 7
- 239000003960 organic solvent Substances 0.000 claims description 6
- 238000004140 cleaning Methods 0.000 claims description 5
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- 238000002583 angiography Methods 0.000 claims description 4
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- 238000012216 screening Methods 0.000 claims description 4
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- 238000003287 bathing Methods 0.000 claims description 3
- 238000013152 interventional procedure Methods 0.000 claims description 3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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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
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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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
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
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- A—HUMAN NECESSITIES
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- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P10/00—Technologies related to metal processing
- Y02P10/25—Process efficiency
Abstract
The invention relates to a micro-catheter shaping auxiliary die for aneurysm interventional operation and a manufacturing method thereof, and the micro-catheter shaping auxiliary die comprises a transparent die main body, wherein an internal space which is completely matched with a parent artery is arranged in the die main body, the internal space is used for placing a micro-catheter, a hole for fixing the micro-catheter is arranged in the aneurysm in the die main body, and the diameter of the hole is 0.05-0.2 mm larger than that of the micro-catheter to be shaped; on the main body of the mould, a slot communicated with the outside is arranged along the blood flow direction in the parent artery, and the slot is arranged opposite to the hemangioma. The invention has the advantages that: the invention supports the shaping of complex shapes, can be bent by more than 5 times as required, and obviously increases the stability and the accuracy of the placement of the catheter; and quick intuition: the invention has transparent or semitransparent appearance, can directly observe the state of the catheter in the mold, and can adjust and guide to achieve the shape conforming to the habit of doctors.
Description
Technical Field
The invention belongs to the technical field of medical instruments, particularly relates to the field of auxiliary medical instruments for aneurysm treatment by adopting interventional operations, and particularly relates to an aneurysm interventional operation micro-catheter shaping auxiliary die and a manufacturing method thereof.
Background
The common treatment modalities for existing aneurysms include surgical treatment and endovascular intervention. The intravascular interventional therapy mainly comprises a spring coil embolism, a blood flow guiding device and the like.
Among them, the coil embolism is the most common interventional therapy method at present. During embolization, the most critical step is to precisely over-select a coil-delivering microcatheter into the target aneurysm, and microcatheter shaping formally addresses this issue. The existing microcatheter placing technology has the main problems that the time delay before or during the operation is long, and because the blood vessel at the focus is usually relatively tortuous, if the natural shape of the microcatheter is inconsistent with the shape and the structure of the blood vessel and the aneurysm, the embolization filler in the microcatheter is very difficult to be sent into the aneurysm for filling and blocking; therefore, the operation is often repeated to affect the success of the treatment and operation. Therefore, in most cases, microcatheter shaping is required prior to surgery. Inaccurate microcatheter shaping can cause obstruction of microcatheter intervention in an operation, and rapid filling of embolization material into aneurysm, thereby inevitably prolonging operation time and causing many problems of repeated shaping of microcatheter.
In the process of treating aneurysm through microcatheter embolization interventional operation, it is usually necessary to perform three-dimensional representation of blood vessel distribution at the lesion site and the connection position between the vascular structure and aneurysm through CT angiography imaging (CTA) or equivalent MRA, DSA, etc. which are commonly used by those skilled in the art, and a doctor selects several possible methods to perform microcatheter modeling according to the blood vessel modeling of CT imaging:
(1) moulding needle of manual bending: the microcatheter is wound on a steel needle with curvature radian approximately equal to the curvature of a focus blood vessel or manually bent by doctor experience manually, and high-temperature fumigation is carried out, so that the purpose of shaping and shaping the microcatheter is achieved, otherwise, in the process of introducing the microcatheter into the blood vessel, the structure is complex due to large bending amplitude of the blood vessel at the focus, and if the natural shape of the microcatheter is inconsistent with the shape and structure of the blood vessel and aneurysm, embolic filler in the microcatheter is very difficult to be sent into the aneurysm for filling and blocking; therefore, the operation is often repeated for this reason, which affects the success of the treatment and operation of the patient. Because the blood vessel distribution of each patient is different, the prior art completely depends on the subjective judgment of the experience of doctors, and has great errors, so that the shaping precision can not be ensured, and the probability of obstacles existing in the follow-up operation is increased.
In addition, the above method has other disadvantages. For example, the length of the shaping needle restricts the number of shaping bends of the catheter; error superposition: manual imitation, conduit springback and small bending quantity; easily damaging the catheter, etc.
(2) Simulating a bent shape of the catheter based on an algorithm, comparing images or an entity after 3D printing output based on the model, bending the shaping needle, and repeating the operation (1) (related patent application numbers: 201710628619, 2017106494831)
(3) Shaping by an auxiliary shaping mould (related patent application numbers: 2018105592329, 2018102200994, 2016102897044). And (3) penetrating the micro-catheter into a mold for fixing, and then carrying out high-temperature fumigation molding.
In the prior art, the method (1) depends on empirical judgment, and the operation effects of different doctors are greatly different; if the method (2) is not used for printing, the bending operation shaping needle difficulty and error are larger, the error is reduced after 3D printing, the error still exists, the operation effect is difficult to guarantee after the error is superposed with the algorithm error, and the operation difficulty is increased due to the fact that the shape generated by the algorithm is different from the operation habit of a doctor; the method (3) avoids the errors of the two methods, and the shaping result is visual, but the existing die preparation methods are difficult to put in and fix the microcatheter at an ideal position. Therefore, it is desirable to develop an accurate, stable and simple method for manufacturing a micro-catheter for aneurysm interventional surgery.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides an aneurysm interventional operation microcatheter shaping auxiliary die and a manufacturing method thereof.
The technical scheme of the invention comprises the following steps:
the invention provides an aneurysm interventional operation micro-catheter shaping auxiliary die, which is characterized by comprising a transparent die main body, wherein an internal space which is completely matched with an aneurysm-carrying artery extending along an artery axis is arranged in the die main body, the aneurysm on the aneurysm-carrying artery is positioned in the internal space, the internal space is used for placing a micro-catheter, a hole for penetrating through the micro-catheter is arranged on the die main body close to the aneurysm, and the diameter of the hole is 0.05mm-0.2mm larger than the diameter of the shaped micro-catheter; on the mold body, a slot communicating with the outside is provided, said slot being configured to allow the microcatheter to be laterally inserted into said internal space.
In some preferred embodiments, the mould body is formed as a tube extending along the axis of the artery, having a proximal end and a distal end, the slot extending continuously from the proximal end to the distal end.
In some preferred embodiments, the slot is formed as a helix about the arterial axis.
In some preferred embodiments, the material of the mold main body is photosensitive resin and is obtained by 3D printing.
The invention provides a manufacturing method of an aneurysm interventional operation micro-catheter shaping auxiliary die, which is characterized by comprising the following steps of:
s1, contrast: obtaining a blood vessel image original data packet A01 containing focus aneurysm and parent artery image by radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01;
s3, processing the die: processing the 3D mathematical model B01 by using 3D modeling software to generate a shaping mold file C01;
s4, 3D printing and processing: using a printer, selecting transparent photosensitive resin which can resist 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to perform additional support and slicing treatment on a printable model G01 of a plastic mould file C01, wherein the thickness of the slice is 0.05-0.1mm, and introducing the slice into the printer for printing; after printing, cleaning by using a cleaning agent, heating, curing, removing the support and polishing the sharp part to obtain a die main body E01;
s5, placing and shaping a microcatheter:
5-1, after disinfecting the micro catheter, laterally placing the micro catheter into the mold main body along the slot, wherein the far end of the micro catheter extends out of the hole, and the extending length is adjusted according to the top neck distance of the aneurysm to ensure that the far end of the mold main body is fixed in the anatomical center of the aneurysm;
5-2, pushing and pulling the micro-catheter to enable the micro-catheter to move towards and attach to a tangent line of the bending part of the main body of the mould; fixing the micro-catheter and the die main body, and heating and shaping;
in the step 5-2, the bending position of the mould main body is not less than five.
In some preferred embodiments, the step S3 is specifically:
3-1, screening the aneurysm and a proximal parent artery, wherein the length of the parent artery is more than or equal to 3cm, smoothing burr noise points generated by scanning to generate a model D01,
3-2, removing 1/2-1/3 or all the diameters of the aneurysm body of the aneurysm as required, exposing the anatomical center or the position nearby of the aneurysm to obtain a model E01, uniformly generating a shell F01 with a certain thickness by the model E01, and finally outputting a printable model G01.
In some preferred embodiments, in said step 3-2, in combination with model E01, a shell F01 is prepared having a thickness, as determined by the toughness and transparency of the printed material, of not less than 0.5mm and not more than 0.1 mm; at the aneurysm or the neck of the aneurysm of the shell F01, a hole is formed according to the molding requirement of the microcatheter, and the diameter of the hole is larger than the diameter range of the molding catheter by 0.05mm-0.2 mm.
In some preferred embodiments, it is characterized by the fact that, for sheath F01, a slot is made along the direction of the parent artery, remaining continuously open from the proximal end to the distal end, the slot being helically curved and passing through the vessel wall contralateral to the aneurysm, facilitating microcatheter placement; the groove is formed to avoid passing through the bent protruding part of the blood vessel so as to prevent the micro catheter from popping out, and air holes with the diameter of 0.5-1mm are uniformly formed on the periphery of the micro catheter so as to accelerate the passing of steam or hot water; when the length of the parent artery is too short, a handle with the length of 1-3cm is added at the near end to facilitate clamping and fixing during heating; the printable model G01 is finally output.
The arrangement of the air holes can release partial stress caused by bending of the auxiliary die after printing, and prevent deformation of the die caused by stress concentration in the die for a long time so as to influence the service life and the shaping accuracy of the die; secondly, volatile matters on the inner wall of the micro-catheter and the die are discharged in time through the air holes in the subsequent heating and shaping process, and the shaping effect is not influenced.
In some preferred embodiments, the step S1 is performed by using digital subtraction angiography.
In some preferred embodiments, in step S4, the organic solvent is absolute alcohol or isopropanol, the curing temperature is 80-100 ℃, the curing time is 1 minute, or the organic solvent is placed in a sunlight-dry place for 6-8 hours.
In some preferred embodiments, in step S5, the specific step of heating for plasticity is: bathing with hot water of more than 80 ℃ for 10-30 seconds, and then cooling and shaping in cold water; or steaming with water vapor for 10-30 s, and cooling with cold water.
Advantages of the present invention over the prior art (e.g. 2018105592329, 2018102200994, 2016102897044) include:
1. supporting the shaping of complex shapes the invention can perform more than 5 bends as required, significantly increasing the stability and accuracy of catheter placement.
2. The method is rapid and intuitive: the invention has transparent or semitransparent appearance, can directly observe the state of the catheter in the mold, and can adjust and guide to achieve the shape according with the habit of doctors.
3. Operable to: the fenestration allows the microcatheter to be placed very easily and more quickly inside the aneurysm than if it were inserted through several circuitries from the proximal end.
4. Accurate repeated engraving: the arrangement of the air holes can release partial stress caused by bending of the auxiliary die after printing, and prevent deformation of the die caused by stress concentration in the die for a long time so as to influence the service life and the shaping accuracy of the die; meanwhile, volatile matters on the inner wall of the micro-catheter and the die are discharged in time through the air holes in the subsequent heating and shaping process, and the shaping effect is not influenced.
Drawings
FIG. 1 is a schematic diagram of a 3D mathematical model construction according to the present invention.
FIG. 2 is another schematic diagram of the construction of the 3D mathematical model of the present invention.
FIG. 3 is a schematic view of the structure of an aneurysm and proximal parent artery of the present invention.
FIG. 4 is a schematic diagram of one of the structures of the model D01 according to the present invention.
FIG. 5 is another schematic diagram of the structure of model E01 according to the present invention.
Fig. 6 is a schematic structural view of a model shell F01 according to the present invention.
FIG. 7 is a schematic view of the model of the present invention after adding support and slicing treatment.
FIG. 8 is a schematic diagram of the structure of the inventive mold after opening.
FIG. 9 is a schematic diagram of the grooved model of the present invention.
Fig. 10 is a schematic structural view of fig. 9 after the vent holes are formed.
FIG. 11 is a schematic diagram of a printing structure of the printer of the present invention.
FIG. 12 is a schematic view of a microcatheter of the present invention positioned for molding in a mold of the present invention.
Detailed Description
The invention is further described below in conjunction with specific embodiments, and the advantages and features of the invention will become more apparent as the description proceeds. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and substitutions are intended to be within the scope of the invention.
The structural schematic diagram of the 3D mathematical model of the micro-catheter shaping auxiliary mold for the aneurysm interventional operation is shown in fig. 1. It should be noted that fig. 1 is only one of the models of the molding auxiliary molds for aneurysm interventional procedure microcatheter of the present invention, and it is fully possible to set specific processes and parameters during the manufacturing process according to the actual specific requirements, such as the number of bends, the diameter of the opening, the width of the slot, and so on. Referring to fig. 1, the main body 1 of the molding auxiliary microcatheter for aneurysm interventional operation is different from the prior art structure in that it has a slot 2, which is provided to allow the microcatheter to be laterally inserted into the inner space. An internal space which is completely inosculated with a parent artery extending along the axis of the artery is arranged in the main body 1 of the mould, the aneurysm on the parent artery is positioned in the internal space, and the internal space is used for placing a micro-catheter through the open slot 2; meanwhile, a hole for passing through the micro-catheter is arranged on the die body 1 close to the aneurysm, the diameter of the hole is larger than that of the shaped micro-catheter, and the hole diameter is preferably 0.05-0.2 mm larger than that of the micro-catheter in consideration of convenience in passing through the micro-catheter and appropriate compatibility of the placed artery and the interventional catheter. Fig. 2 is another schematic diagram of the 3D mathematical model of the present invention having different bends and notching locations.
The structure schematic diagram of the aneurysm and the proximal parent artery is shown in fig. 3. Obviously, the structural complexity of the parent artery is complex, and the parent artery has a plurality of bends and surface bulges, and meanwhile, tumor masses are distributed at the far end of the artery. The invention relates to an auxiliary molding die for micro-catheter shaping in an aneurysm interventional operation, which aims to make the structure of the micro-catheter consistent with that of an artery and an aneurysm as much as possible, so that an auxiliary molding tool is designed.
Fig. 4 to fig. 11 schematically show the model structure of the aneurysm interventional operation microcatheter shaping auxiliary mold in each stage of manufacturing.
The material of the die main body is preferably photosensitive resin and is obtained by 3D printing. Processing a mould: the constructed 3D mathematical model B01 is processed by using 3D modeling software to generate a shaping mold file C01, and then the aneurysm and the proximal parent artery are scanned and screened to generate a model D01, wherein the structure is shown in FIG. 4.
According to 1/2-1/3 or all of the tumor diameters of the tumors according to requirements, the position at or near the anatomical center of the aneurysm is exposed, and a model structure E01 is obtained, and the structure is shown in figure 5.
The printable model of the plastic mould file is subjected to additional supporting and slicing treatment by using the slicing software of the printer, the slicing thickness is 0.05-0.1mm, and the structure is shown in fig. 6. The model structure of FIG. 6 is introduced into a printer for printing.
On the basis of the above model, a shell F01 having a certain thickness is generated, and the structure is shown in fig. 7. The thickness of the shell is determined according to the toughness and transparency of the printing material, and is not less than 0.5mm and not more than 0.1 mm.
At the aneurysm or the neck of the aneurysm of the shell F01, holes are formed according to the molding requirement of the microcatheter, the diameter of the holes is larger than that of the molding catheter and ranges from 0.05mm to 0.2mm, and the structural schematic diagram is shown in figure 8. The printable model G01 is finally output.
For the shell F01, the groove is formed along the trend of the parent artery, and the structural schematic diagram is shown in figure 9. The opening groove passes through the blood vessel wall on the opposite side of the hemangioma, so that the micro catheter can be conveniently placed; the slots avoid passing the protruding part of the vessel curve to prevent the microcatheter from popping out.
Air holes with the diameter of 0.5-1mm are uniformly formed in the periphery of the micro-catheter shaping mold, and the structure is schematically shown in figure 10, so that the passing of steam or hot water is accelerated; when the length of the parent artery is too short, a handle with the length of 1-3cm is added at the proximal end to facilitate clamping and fixing during heating.
Finally outputting the printable model, after printing, cleaning with a cleaning agent matched with the resin, heating and curing, removing the support and polishing the sharp part, and the obtained structural schematic diagram of the specific mold is shown in fig. 11.
The schematic structural diagram of the microcatheter of the invention when placed in the model for shaping is shown in fig. 12, and it can be seen that the microcatheter has good compatibility with the auxiliary mold of the invention: the mould main body is provided with a notch communicated with the outside along the blood flow direction in the parent artery, and the notch can also be spirally notched along the axis of the blood vessel, so that the micro-catheter is prevented from popping up in the preparation process. And according to the requirement, heating, cooling and the like are carried out during the shaping and fixing.
The following is a disclosure of specific operating procedures and parameters of embodiments of the invention.
Example 1:
a method for preparing an aneurysm interventional operation micro-catheter shaping auxiliary die is characterized by comprising the following steps:
s1, contrast: obtaining a blood vessel image original data packet A01 of a focus aneurysm and a parent artery image by radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01; (ii) a
S3, processing the die: processing the 3D mathematical model B01 by using 3D modeling software to generate a shaping mold file C01;
s4, 3D printing and processing: using a printer, selecting transparent photosensitive resin which can resist 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to perform additional support and slicing treatment on a printable model G01 of a plastic mould file C01, wherein the thickness of the slice is 0.05-0.1mm, and introducing the slice into the printer for printing; and after printing, cleaning by using a cleaning agent matched with the resin, heating, curing, removing the support, and polishing the sharp part to obtain a mold E01.
S5, placing and shaping a microcatheter:
5-1, after disinfecting the micro catheter, placing the micro catheter into the mold main body along the open groove, wherein the far end extends out of the hole, and the extending length is adjusted according to the top neck distance of the aneurysm to ensure that the far end is fixed at the anatomical center of the aneurysm;
5-2, pushing and pulling the micro-catheter to enable the micro-catheter to move towards and attach to a tangent line of the bending part of the main body of the mould; and fixing the micro-catheter and the die main body for heating and shaping.
The step S3 specifically includes:
3-1, screening the aneurysm and a near-end parent artery, wherein the parent artery is longer than or equal to 3cm, and smoothing burr noise points generated by scanning to generate a model D01;
3-2, removing 1/2-1/3 or all the tumor body diameters of the tumor bodies as required, exposing the anatomical center or the nearby position of the aneurysm to obtain a model E01, uniformly generating a shell F01 with a certain thickness by the model E01, and finally outputting a printable model G01.
In the step 3-2, combining the model E01, preparing a shell F01 with a certain thickness, wherein the thickness of the shell is determined according to the toughness and transparency of the printing material and is not less than 0.5mm and not more than 0.1 mm; at the aneurysm or the neck of the aneurysm of the shell F01, holes are formed according to the molding requirement of the microcatheter, and the diameter of the holes is set to be larger than the diameter range of the molding catheter by 0.05mm-0.2 mm.
For the shell F01, a groove is formed along the trend of the parent artery, and the groove passes through the blood vessel wall on the opposite side of the hemangioma, so that the micro catheter can be conveniently placed; the groove is formed to avoid passing through the bent protruding part of the blood vessel so as to prevent the micro catheter from popping out, and air holes with the diameter of 0.5-1mm are uniformly formed on the periphery of the micro catheter so as to accelerate the passing of steam or hot water; when the length of the parent artery is too short, a handle with the length of 1-3cm is added at the near end to facilitate clamping and fixing during heating; the printable model G01 is finally output.
The step S1 adopts digital subtraction angiography.
In the step 5-2, the bending position of the mould main body is not less than five.
In the step S4, the organic solvent is absolute alcohol or isopropanol, the curing temperature is 80-100 ℃, and the curing time is 1 minute.
In step S5, the specific steps of heating and plasticizing are as follows: bathing in hot water of 80 deg.C for 10-30 s, and cooling in cold water.
Example 2:
a method for preparing an aneurysm interventional operation micro-catheter shaping auxiliary die is characterized by comprising the following steps:
s1, contrast: obtaining a blood vessel image original data packet A01 containing focus aneurysm and parent artery image by radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01; (ii) a
S3, processing of the die: processing the 3D mathematical model B01 by using 3D modeling software to generate a shaping mold file C01;
s4, 3D printing and processing: using a printer, selecting transparent photosensitive resin which can resist 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to perform additional support and slicing treatment on a printable model G01 of a plastic mould file C01, wherein the thickness of the slice is 0.05-0.1mm, and introducing the slice into the printer for printing; and after printing, cleaning by using a cleaning agent matched with the resin, heating, curing, removing the support, and polishing the sharp part to obtain a mold E01.
S5, placing and shaping a microcatheter:
5-1, after disinfecting the micro catheter, placing the micro catheter into the mold main body along the open groove, wherein the far end extends out of the hole, and the extending length is adjusted according to the top neck distance of the aneurysm to ensure that the far end is fixed at the anatomical center of the aneurysm;
5-2, pushing and pulling the micro-catheter to enable the micro-catheter to move towards and attach to a tangent line of the bending part of the main body of the mould; and fixing the micro-catheter and the die main body for heating and shaping.
The step S3 specifically includes:
3-1, screening the aneurysm and a near-end parent artery with the parent artery length being more than or equal to 3cm, smoothing burr noise points generated by scanning to generate a model D01,
3-2, removing 1/2-1/3 or all the tumor body diameters of the tumor bodies as required, exposing the anatomical center or the nearby position of the aneurysm to obtain a model E01, uniformly generating a shell F01 with a certain thickness by the model E01, and finally outputting a printable model G01.
In the step 3-2, combining the model E01, preparing a shell F01 with a certain thickness, wherein the thickness of the shell is determined according to the toughness and transparency of the printing material and is not less than 0.5mm and not more than 0.1 mm; at the aneurysm or the neck of the aneurysm of the shell F01, holes are formed according to the molding requirement of the microcatheter, and the diameter of each hole is larger than the diameter range of the microcatheter by 0.05mm-0.2 mm.
For the shell F01, a model F03 is formed by slotting along the trend of the parent artery, and the slot passes through the blood vessel wall on the opposite side of the hemangioma, so that the micro catheter can be conveniently placed; the slot is continuously opened from the near end to the far end and is spirally or moderately bent, so that the slot is prevented from passing through a protruding part of the bent blood vessel and preventing the microcatheter from popping out; air holes with the diameter of 0.5-1mm are uniformly formed in the periphery of the micro-catheter to accelerate the steam or hot water to pass through; when the length of the parent artery is too short, a handle with the length of 1-3cm is added at the near end to facilitate clamping and fixing during heating; the printable model G01 is finally output.
The step S1 adopts digital subtraction angiography.
In the step 5-2, the bending position of the mould main body is not less than five positions.
In the step S4, the organic solvent is absolute alcohol or isopropyl alcohol, and when cured, the cured product is placed in a dry place in the sun (summer) for 6 to 8 hours.
In the step S5, the specific step of heating plasticity is steaming with water vapor for 10-30 seconds, and then cooling with cold water for shaping.
Based on the steps, the method supports the shaping of the complex shape, and can perform more than 5 bends as required, so that the stability and the accuracy of the placement of the catheter are obviously improved.
The invention has transparent or semitransparent appearance, can directly observe the state of the catheter in the die, and can adjust and guide to achieve the shape according with the habit of doctors.
Operable to: the continuous open slot allows for easy placement of the microcatheter, allowing faster access to the interior of the aneurysm die than insertion through several tortuosity from the proximal end, and the convoluted slot prevents the microcatheter from popping out after placement.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered as the technical solutions and the inventive concepts of the present invention within the technical scope of the present invention.
Claims (10)
1. An aneurysm interventional operation micro-catheter shaping auxiliary die is characterized by comprising a transparent die main body, wherein an internal space which is completely matched with an aneurysm-carrying artery extending along the axis of the artery is arranged in the die main body, the aneurysm on the aneurysm-carrying artery is positioned in the internal space, the internal space is used for placing a micro-catheter, a hole for penetrating through the micro-catheter is arranged on the die main body close to the aneurysm, and the diameter of the hole is larger than the diameter of the shaped micro-catheter by 0.05mm-0.2 mm; on the mold body, a slot communicating with the outside is provided, said slot being configured to allow the lateral insertion of the microcatheter into said internal space.
2. The aneurysm interventional procedure microcatheter shaping aid mold of claim 1, wherein the mold body is formed in a tubular shape extending along an artery axis, having a proximal end and a distal end, the slot extending continuously from the proximal end to the distal end.
3. The aneurysm interventional procedure microcatheter shaping aid mold of claim 1, wherein the slot is formed in a spiral about the artery axis.
4. A method for preparing the aneurysm interventional operation microcatheter shaping auxiliary mold of any one of claims 1 to 3, comprising the steps of:
s1, contrast: obtaining a blood vessel image original data packet A01 containing focus aneurysm and parent artery image by radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01;
s3, processing of the die: processing the 3D mathematical model B01 by using 3D modeling software to generate a shaping mold file C01;
s4, 3D printing and processing: using a printer, selecting transparent photosensitive resin which can resist 100 ℃ high temperature and does not deform and release toxic substances, using the printer with slicing software, carrying out additional support and slicing treatment on a printable model G01 of a shaping mold file C01, wherein the slicing thickness is 0.05-0.1mm, and introducing into the printer for printing; after printing, cleaning by using a cleaning agent, heating for solidification, removing the support, and polishing the sharp part to obtain a die main body E01;
s5, placing and shaping a microcatheter:
5-1, after disinfecting the micro catheter, laterally placing the micro catheter into the mold main body along the slot, wherein the far end of the micro catheter extends out of the hole, and the extending length is adjusted according to the top neck distance of the aneurysm to ensure that the far end of the mold main body is fixed in the anatomical center of the aneurysm;
5-2, pushing and pulling the micro-catheter to enable the micro-catheter to move towards and attach to a tangent line of the bending part of the main body of the mould; fixing the micro-catheter and the mould main body, and heating and shaping;
in the step 5-2, the bending position of the mould main body is not less than five.
5. The method according to claim 4, wherein the step S3 specifically comprises:
3-1, screening the aneurysm and a near-end parent artery with the parent artery length being more than or equal to 3cm, smoothing burr noise points generated by scanning to generate a model D01,
3-2, removing 1/2-1/3 or all the diameters of the aneurysm body of the aneurysm as required, exposing the anatomical center or the position nearby of the aneurysm to obtain a model E01, uniformly generating a shell F01 with a certain thickness by the model E01, and finally outputting a printable model G01.
6. The method as claimed in claim 5, wherein in said step 3-2, in combination with the model E01, a shell F01 is prepared with a thickness, determined according to the toughness and transparency of the printed material, of not less than 0.5mm and not more than 0.1 mm; at the aneurysm or the neck of the aneurysm of the shell F01, a hole is formed according to the molding requirement of the microcatheter, and the diameter of the hole is 0.05mm-0.2mm larger than that of the molding catheter.
7. The method of claim 4, wherein sheath F01 is slotted along the direction of the parent artery, remaining continuously open from the proximal end to the distal end, and is helically curved and passes through the vessel wall contralateral to the aneurysm to facilitate microcatheter placement; the groove is formed to avoid passing through the bent protruding part of the blood vessel so as to prevent the micro catheter from popping out, and air holes with the diameter of 0.5-1mm are uniformly formed on the periphery of the micro catheter so as to accelerate the passing of steam or hot water; when the length of the parent artery is too short, a handle with the length of 1-3cm is added at the near end to facilitate clamping and fixing during heating; the printable model G01 is finally output.
8. The method according to claim 3, wherein said step S1 employs digital subtraction angiography.
9. The method according to claim 4, wherein in step S4, the organic solvent is absolute ethyl alcohol or isopropyl alcohol, the curing temperature is 80-100 ℃, the curing time is 1 minute, or the organic solvent is placed in a dry place for 6-8 hours.
10. The method of claim 4, wherein in step S5, the step of heating for plasticity comprises: bathing in hot water of more than 80 deg.C for 10-30 s, and cooling in cold water for shaping; or steaming with water vapor for 10-30 s, and cooling with cold water.
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Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040122362A1 (en) * | 2002-09-10 | 2004-06-24 | Houser Russell A. | Pseudo aneurysm repair system |
| KR20160097736A (en) * | 2015-02-10 | 2016-08-18 | 재단법인 아산사회복지재단 | Guide catheter |
| CN107392872A (en) * | 2017-07-27 | 2017-11-24 | 强联智创（北京）科技有限公司 | The generation method and generation system of a kind of microtubular shaping device |
| CN107468334A (en) * | 2017-08-01 | 2017-12-15 | 强联智创（北京）科技有限公司 | A kind of moulding aided design system of three-dimensional microtubular and design method |
| CN108407266A (en) * | 2018-03-16 | 2018-08-17 | 黎悦 | Microtubular shaping device |
| CN108478918A (en) * | 2018-06-01 | 2018-09-04 | 成都真实维度科技有限公司 | A kind of aneurysm intervention operation moulding auxiliary brace of microtubular and preparation method thereof |
| CN207928564U (en) * | 2018-06-01 | 2018-10-02 | 成都真实维度科技有限公司 | A kind of aneurysm intervention operation moulding auxiliary brace of microtubular |
| CN208943185U (en) * | 2017-12-29 | 2019-06-07 | 广州迈普再生医学科技股份有限公司 | A kind of microtubular moulding auxiliary device of 3D printing |
| CN111330135A (en) * | 2020-03-04 | 2020-06-26 | 中国人民解放军总医院第六医学中心 | Aneurysm interventional operation micro-catheter shaping auxiliary support and manufacturing method thereof |
-
2022
- 2022-03-09 CN CN202210230467.XA patent/CN114788919B/en active Active
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040122362A1 (en) * | 2002-09-10 | 2004-06-24 | Houser Russell A. | Pseudo aneurysm repair system |
| KR20160097736A (en) * | 2015-02-10 | 2016-08-18 | 재단법인 아산사회복지재단 | Guide catheter |
| CN107392872A (en) * | 2017-07-27 | 2017-11-24 | 强联智创（北京）科技有限公司 | The generation method and generation system of a kind of microtubular shaping device |
| CN107468334A (en) * | 2017-08-01 | 2017-12-15 | 强联智创（北京）科技有限公司 | A kind of moulding aided design system of three-dimensional microtubular and design method |
| CN208943185U (en) * | 2017-12-29 | 2019-06-07 | 广州迈普再生医学科技股份有限公司 | A kind of microtubular moulding auxiliary device of 3D printing |
| CN108407266A (en) * | 2018-03-16 | 2018-08-17 | 黎悦 | Microtubular shaping device |
| CN108478918A (en) * | 2018-06-01 | 2018-09-04 | 成都真实维度科技有限公司 | A kind of aneurysm intervention operation moulding auxiliary brace of microtubular and preparation method thereof |
| CN207928564U (en) * | 2018-06-01 | 2018-10-02 | 成都真实维度科技有限公司 | A kind of aneurysm intervention operation moulding auxiliary brace of microtubular |
| CN111330135A (en) * | 2020-03-04 | 2020-06-26 | 中国人民解放军总医院第六医学中心 | Aneurysm interventional operation micro-catheter shaping auxiliary support and manufacturing method thereof |
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