CN114788919B - Microcatheter moulding auxiliary mould for aneurysm intervention operation and manufacturing method thereof - Google Patents
Microcatheter moulding auxiliary mould for aneurysm intervention operation and manufacturing method thereof Download PDFInfo
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- 206010002329 Aneurysm Diseases 0.000 title claims abstract description 87
- 238000000465 moulding Methods 0.000 title claims abstract description 30
- 238000004519 manufacturing process Methods 0.000 title abstract description 9
- 238000007493 shaping process Methods 0.000 claims abstract description 51
- 210000001367 artery Anatomy 0.000 claims abstract description 30
- 238000005452 bending Methods 0.000 claims description 22
- 238000000034 method Methods 0.000 claims description 22
- 238000010438 heat treatment Methods 0.000 claims description 18
- 210000004204 blood vessel Anatomy 0.000 claims description 17
- 238000007639 printing Methods 0.000 claims description 17
- 206010028980 Neoplasm Diseases 0.000 claims description 14
- 238000012545 processing Methods 0.000 claims description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- 238000013178 mathematical model Methods 0.000 claims description 13
- 238000011282 treatment Methods 0.000 claims description 11
- 238000009423 ventilation Methods 0.000 claims description 10
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 9
- 239000011347 resin Substances 0.000 claims description 9
- 229920005989 resin Polymers 0.000 claims description 9
- 238000010146 3D printing Methods 0.000 claims description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 8
- 239000012459 cleaning agent Substances 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 7
- 238000004140 cleaning Methods 0.000 claims description 5
- 238000005498 polishing Methods 0.000 claims description 5
- 238000012216 screening Methods 0.000 claims description 5
- 238000002583 angiography Methods 0.000 claims description 4
- 238000009499 grossing Methods 0.000 claims description 4
- 231100000614 poison Toxicity 0.000 claims description 4
- 238000002601 radiography Methods 0.000 claims description 4
- 239000003440 toxic substance Substances 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 3
- 230000000149 penetrating effect Effects 0.000 claims description 3
- 238000010025 steaming Methods 0.000 claims description 2
- 201000011066 hemangioma Diseases 0.000 abstract description 4
- 230000017531 blood circulation Effects 0.000 abstract description 3
- 230000000007 visual effect Effects 0.000 abstract description 3
- 238000010586 diagram Methods 0.000 description 12
- 238000001356 surgical procedure Methods 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 230000003073 embolic effect Effects 0.000 description 4
- 239000003960 organic solvent Substances 0.000 description 4
- 230000002792 vascular Effects 0.000 description 4
- 238000010276 construction Methods 0.000 description 3
- 230000010102 embolization Effects 0.000 description 3
- 238000006467 substitution reaction Methods 0.000 description 3
- 230000000903 blocking effect Effects 0.000 description 2
- 238000010968 computed tomography angiography Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000003958 fumigation Methods 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 238000013152 interventional procedure Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 229910000831 Steel Inorganic materials 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000013170 computed tomography imaging Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
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- 230000002035 prolonged effect Effects 0.000 description 1
- 238000007711 solidification Methods 0.000 description 1
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- 239000010959 steel Substances 0.000 description 1
Classifications
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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
-
- 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
- B33Y80/00—Products made by additive manufacturing
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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
- A61B2017/1205—Introduction devices
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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
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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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P10/00—Technologies related to metal processing
- Y02P10/25—Process efficiency
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Abstract
The invention relates to a microcatheter moulding auxiliary mould for an aneurysm intervention operation and a manufacturing method thereof, comprising a transparent mould main body, wherein an inner space which is completely matched with a carrying aneurysm is arranged in the mould main body, the inner space is used for placing a microcatheter, a hole for fixing the microcatheter is arranged in the aneurysm in the mould main body, and the diameter of the hole is 0.05-0.2 mm larger than that of the moulded microcatheter; the mould main body is provided with a slot communicated with the outside along the blood flow direction in the aneurysm-carrying artery, and the slot is arranged opposite to the hemangioma. The invention has the advantages that: the invention can carry out more than 5 curves according to the need to support the shaping of complex shape, and the stability and the accuracy of the catheter placement are obviously improved; and (3) quick and visual: the invention has transparent or semitransparent appearance, can directly observe the state of the catheter in the die, and can adjust and guide the catheter to conform to the habit of doctors.
Description
Technical Field
The invention belongs to the technical field of medical instruments, in particular to the field of auxiliary medical instruments for carrying out aneurysm treatment by adopting interventional operation, and particularly relates to a microcatheter shaping auxiliary die for the aneurysm interventional operation and a manufacturing method thereof.
Background
Current common treatments for aneurysms include surgical and endovascular interventions. Intravascular interventional procedures mainly include coil embolization, blood flow guiding devices, and the like.
Among them, coil embolization is currently the most commonly used interventional procedure. In the embolization process, the most critical step is to precisely and super-select the microcatheter for delivering the spring coil into the target aneurysm, while microcatheter shaping formally solves the key of the problem. The existing microcatheter placement technology has the main problems that the time delay is long before or during the operation, and because the blood vessels at the focus are often in a tortuous path, if the natural morphology of the microcatheter is inconsistent with the morphological structures of the blood vessels and the aneurysms, the embolic filler in the microcatheter is very difficult to be sent into the aneurysms for filling and blocking; thus, the cause of the surgery is often repeated to affect the success of the patient treatment and surgery. Therefore, microcatheter shaping is often required prior to surgery. The inaccuracy of the microcatheter molding can cause the interference of the microcatheter intervention in the operation, and the embolic material can not be filled in the aneurysm rapidly, thereby inevitably prolonging the operation time and repeatedly molding the microcatheter.
In the process of performing a microcatheter embolic interventional operation to treat an aneurysm, a three-dimensional representation of the vascularity at a focus and the connection position between a vascular structure and the aneurysm is usually required by means of CT angiography imaging (CTA) or equivalent MRA, DSA and the like commonly used by those skilled in the art, and a doctor performs microcatheter molding according to the vascular modeling of CT imaging by selecting the following possible modes:
(1) Manual bending shaping needle: the microcatheter is wound on a steel needle with curvature radian approximately equal to that of a focus blood vessel or manually bent by virtue of doctor experience, 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 because the bending amplitude of the blood vessel at the focus is large, and if the natural shape of the microcatheter is inconsistent with the shape and structure of the blood vessel and the aneurysm, the embolic filler in the microcatheter is very difficult to be fed into the aneurysm for filling and blocking; thus, surgery is often repeated for this reason, affecting patient treatment and the success of the surgery. Because the vascular distribution of each patient is different, the prior art completely depends on subjective judgment of the experience of doctors, and has great error, the shaping precision cannot be ensured, and the probability of the occurrence of obstacle 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; and (3) error superposition: the number of manual imitation, catheter rebound and bending is small; easily damaging the catheter, etc.
( 2) Based on the algorithm simulating the bending shape of the catheter, based on the model, comparing the image or the entity after 3D printing output, bending the shaping needle, and repeating the operation of (1) (related patent application number: 201710628619, 2017106494831 )
(3) Shaping by an auxiliary shaping die (related patent application number: 2018105592329, 2018102200994, 2016102897044). And penetrating the microcatheter into a die for fixing, and then carrying out high-temperature fumigation shaping.
In the prior art, the method (1) is very dependent on experience judgment, and the operation effects of different doctors are very different; if the method (2) is not used for printing, the difficulty and the error of the comparison operation bending shaping needle are large, the error after 3D printing is reduced, but the error still exists, the operation effect is difficult to ensure after the error is overlapped 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 errors in the two modes, and the shaping result is visual, but the traditional mould preparation method is difficult to put in and fix the microcatheter at an ideal position. Therefore, there is a need to develop a precise, stable and simple method for manufacturing the microcatheter for the interventional operation of aneurysms.
Disclosure of Invention
In order to overcome the defects in 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 microcatheter shaping auxiliary die which is characterized by comprising a transparent die body, wherein an inner space which is completely matched with a carrying aneurysm extending along an arterial axis is arranged in the die body, an aneurysm on the carrying aneurysm is positioned in the inner space, the inner space is used for placing a microcatheter, a hole which is used for penetrating the microcatheter is arranged on the die body near the aneurysm, and the diameter of the hole is 0.05mm-0.2mm larger than the diameter of the shaped microcatheter; on the mold body, a slot is provided in communication with the outside, the slot being configured to allow the microcatheter to be laterally placed into the interior space.
In some preferred embodiments, the die body is formed in a tubular shape extending along an arterial axis, 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 in a spiral shape around the arterial axis.
In some preferred embodiments, the material of the mold body is photosensitive resin, and the mold body is obtained through 3D printing.
The invention also provides a manufacturing method of the microcatheter molding auxiliary die for the aneurysm interventional operation, which is characterized by comprising the following steps of:
s1, contrast: obtaining a blood vessel image original data packet A01 of focal aneurysms and aneurysm-carrying artery images through radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01;
s3, processing a die: processing the 3D mathematical model B01 by using 3D modeling software to generate a molding die file C01;
s4, 3D printing and processing: using a printer to select transparent photosensitive resin which can resist high temperature of 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to carry out increasing support and slicing treatment on a printable model G01 of a molding die file C01, leading the slicing thickness to be 0.05-0.1mm, and leading the slice into the printer for printing; after printing, cleaning by using a cleaning agent, heating, solidifying, removing supports, and polishing sharp parts to obtain a die main body E01;
s5, placing and shaping the microcatheter:
5-1, after the microcatheter is sterilized, the microcatheter is placed into the die main body along the side direction of the slot, the distal end extends out of the hole, and the extension length is adjusted according to the top neck distance of the aneurysm, so that the distal end of the die main body is ensured to be fixed at the anatomical center of the aneurysm;
5-2, pushing and pulling the microcatheter to enable the microcatheter to run towards a tangent line at the bending part of the bonding die main body; fixing the microcatheter and the mould main body well for heating and shaping;
in the step 5-2, the bending position of the die main body is not less than five positions.
In some preferred embodiments, the step S3 is specifically:
3-1, screening aneurysms and proximal parent carrying arteries, smoothing burr noise points generated by scanning to generate a model D01,
3-2, removing 1/2-1/3 of the aneurysm body diameter of the aneurysm or all the aneurysm body diameters as required, exposing the anatomical center or the position nearby the aneurysm to obtain a model E01, uniformly generating a shell F01 with a certain thickness by the model E01, and finally outputting the printable model G01.
In some preferred embodiments, in said step 3-2, in combination with the model E01, a shell F01 is prepared having a thickness, determined according to the toughness and transparency of the printed material, of not less than 0.5mm and not more than 0.1mm; and opening holes at the aneurysm or neck of the shell F01 according to the molding requirement of the microcatheter, wherein the diameter of the holes is set to be 0.05-0.2 mm larger than the diameter of the molding catheter.
In some preferred embodiments, the housing F01 is slotted along the course of the parent artery, remaining continuously open from the proximal end to the distal end, the slot being helically curved and passing over the wall of the vessel opposite the aneurysm for ease of microcatheter placement; grooving to avoid protruding parts passing through the bending of blood vessels so as to prevent the micro-catheter from being ejected, and uniformly arranging ventilation holes with the diameter of 0.5-1mm at the periphery of the micro-catheter so as to accelerate the steam or hot water to pass through; when the length of the tumor-bearing artery is too short, a handle with the length of 1 cm to 3cm is added at the proximal end so as to be convenient for clamping and fixing during heating; the printable model G01 is finally output.
The ventilation holes are formed, so that partial stress caused by bending of the auxiliary die after printing can be released, and the deformation of the die caused by stress concentration of the die for a long time is prevented, so that the service life of the die is prolonged, and the shaping accuracy of the die is further influenced; secondly, volatile matters on the inner wall parts of the microcatheter and the mould are discharged in time through the ventilation holes in the subsequent heating and shaping process, so that the shaping effect is not affected.
In some preferred embodiments, step S1 is performed using digital subtraction angiography.
In some preferred embodiments, in the 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 at a solar drying place for 6-8 hours.
In some preferred embodiments, in the step S5, the specific step of heating the plasticity is: placing the hot water bath with the temperature of more than 80 ℃ for 10-30 seconds in cold water for cooling and shaping; or steaming for 10-30 seconds, cooling with cold water, and shaping.
Advantages of the present invention over the prior art (e.g., 2018105592329, 2018102200994, 2016102897044) include:
1. the invention can carry out more than 5 curves according to the requirement and support the shaping of complex shape, thereby remarkably increasing the stability and accuracy of catheter placement.
2. Quick and visual: the invention has transparent or semitransparent appearance, can directly observe the state of the catheter in the die, and can adjust and guide the catheter to achieve the shape conforming to the habit of doctors.
3. Operable to: the slotting allows the microcatheter to be placed very easily and reach inside the aneurysm more quickly than if it were inserted from the proximal end through several tortuosity.
4. Accurate re-etching: the ventilation holes are arranged, so that partial stress caused by bending of the auxiliary die after printing can be released, and the deformation of the die caused by stress concentration of the die for a long time is prevented, thereby affecting the service life and the shaping accuracy of the die; meanwhile, volatile matters on the inner wall parts of the microcatheter and the die are discharged in time through the ventilation holes in the subsequent heating and shaping process, so that the shaping effect is not affected.
Drawings
FIG. 1 is a schematic structural diagram of a 3D mathematical model construction of the present invention.
Fig. 2 is another structural schematic diagram of the 3D mathematical model construction of the present invention.
Fig. 3 is a schematic diagram of the structure of an aneurysm and proximal parent artery of the present invention.
Fig. 4 is a schematic structural diagram of a model D01 of the present invention.
Fig. 5 is another structural schematic diagram of the model E01 of the present invention.
Fig. 6 is a schematic structural view of the model housing F01 of the present invention.
FIG. 7 is a schematic view of the structure of the model of the present invention after the support and slicing process.
FIG. 8 is a schematic view of the structure of the inventive mold after opening.
Fig. 9 is a schematic structural view of the inventive mold after grooving.
Fig. 10 is a schematic view of the structure of fig. 9 after ventilation holes are formed.
FIG. 11 is a schematic diagram of a printer according to the present invention.
FIG. 12 is a schematic view of the structure of a microcatheter of the present invention when placed in a model shape of the present invention.
Detailed Description
The invention will be further described with reference to specific embodiments, and advantages and features of the invention will become apparent from the description. These examples are merely exemplary and do not limit the scope of the invention in any way. It will be understood by those skilled in the art that various changes and substitutions of details and forms of the technical solution of the present invention may be made without departing from the spirit and scope of the present invention, but these changes and substitutions fall within the scope of the present invention.
The structure diagram of the 3D mathematical model of the microcatheter shaping auxiliary die for the aneurysm intervention operation is shown in figure 1. It should be noted that fig. 1 is only one of the models of the microcatheter molding auxiliary mold for the aneurysm intervention operation, and specific processes and parameters can be set in the manufacturing process according to actual specific requirements, so as to meet the requirements, such as the number of bending parts, the diameter of the opening, the width of the slot, and the like. Referring to fig. 1, the main body 1 of the auxiliary mould for shaping the microcatheter for the intervention of the aneurysm is provided with a slot 2 for allowing the lateral insertion of the microcatheter into said internal space, unlike the prior art constructions. An inner space which is completely matched with an aneurysm-carrying artery extending along the arterial axis is arranged inside the die main body 1, the aneurysm on the aneurysm-carrying artery is positioned in the inner space, and the inner space is used for placing a microcatheter through a slot 2; at the same time, a hole for passing through the microcatheter is provided on the die body 1 near the aneurysm, the diameter of the hole being larger than that of the microcatheter being shaped, and the diameter of the hole is preferably 0.05mm-0.2mm larger than that of the microcatheter in view of convenience in passing through the microcatheter and compatibility of the artery with the interventional catheter after placement. Fig. 2 is a schematic diagram of another 3D mathematical model of the present invention, which has different bending and grooving positions.
The structure of the aneurysm and the proximal parent artery of the present invention is schematically shown in fig. 3. It is evident that the structural complexity of the parent artery has multiple bends and superficial raised areas with tumor mass distributed at the distal end of the artery. The invention relates to an auxiliary mould for shaping a microcatheter for an aneurysm interventional operation, which is an auxiliary shaping tool designed for enabling the microcatheter to be consistent with the structures of an artery and a aneurysm as much as possible.
Fig. 4 to 11 schematically illustrate a model structure of the present invention at each stage of manufacturing a microcatheter molding auxiliary mold for an aneurysm intervention operation.
The material of the die main body is preferably photosensitive resin, and is obtained through 3D printing. And (3) processing a die: and processing the constructed 3D mathematical model B01 by using 3D modeling software to generate a molding die file C01, and then scanning and screening aneurysms and proximal parent-carrying arteries to generate a model D01, wherein the structure is shown in figure 4.
Depending on the desired tumor size, 1/2-1/3 of the tumor size diameter or total removal, the anatomical center or vicinity of the aneurysm is exposed, resulting in a model structure E01, the structure of which is shown in FIG. 5.
The printable model of the shaping mould file is additionally supported and sliced by using the slicing software of the printer, and the slicing thickness is 0.05-0.1mm, and the structure is shown in figure 6. The model structure of fig. 6 is imported into a printer for printing.
On the basis of the above model, a housing F01 having a certain thickness is produced, the structure of which 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 0.1mm.
And (3) opening holes at the aneurysm or neck of the shell F01 according to the molding requirement of the microcatheter, wherein the diameter of the holes is 0.05-0.2 mm larger than that of the molding catheter, and the structural schematic diagram is shown in fig. 8. The printable model G01 is finally output.
For the housing F01, a slot is formed along the direction of the parent artery, and the schematic structure is shown in FIG. 9. The slotting passes through the wall of the side vessel opposite to the hemangioma, so as to facilitate the placement of the microcatheter; the slots avoid protruding portions through which the blood vessel bends, preventing the microcatheter from ejecting.
Ventilation holes with the diameter of 0.5-1mm are uniformly formed in the periphery of the microcatheter molding die, and the structural schematic diagram is shown in figure 10 so as to accelerate steam or hot water to pass through; when the length of the aneurysm-carrying artery is too short, a handle with the length of 1-3cm is added at the proximal end, so that the handle is convenient for clamping and fixing during heating.
And finally outputting the printable model, cleaning by using a cleaning agent matched with resin after printing, heating and solidifying, removing supports and polishing sharp parts, wherein the structural schematic diagram of the obtained specific die is shown in fig. 11.
The structural schematic diagram of the microcatheter of the invention when placed in the model of the invention for shaping is shown in fig. 12, and it can be seen that the microcatheter has good compatibility with the auxiliary die of the invention: the mould main body is provided with a slot communicated with the outside along the blood flow trend in the tumor-bearing artery, and can also spiral the slot along the axis of the blood vessel so as to avoid the ejection of the microcatheter in the preparation process. And heating, cooling and the like when in shaping and fixing according to the requirements.
The following is a disclosure of specific processes and parameters for the operation of embodiments of the present invention.
Example 1:
a method for preparing a microcatheter shaping auxiliary die for an aneurysm interventional operation, which is characterized by comprising the following steps of:
s1, contrast: obtaining a blood vessel image original data packet A01 of focal aneurysms and aneurysm-carrying artery images through radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01; the method comprises the steps of carrying out a first treatment on the surface of the
S3, processing a die: processing the 3D mathematical model B01 by using 3D modeling software to generate a molding die file C01;
s4, 3D printing and processing: using a printer to select transparent photosensitive resin which can resist high temperature of 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to carry out increasing support and slicing treatment on a printable model G01 of a molding die file C01, leading the slicing thickness to be 0.05-0.1mm, and leading the slice into the printer for printing; after printing, cleaning by using a cleaning agent matched with resin, heating, solidifying, removing supports, and polishing sharp parts to obtain a die E01.
S5, placing and shaping the microcatheter:
5-1, after the microcatheter is disinfected, the microcatheter is placed in the die body along the slot, the distal end extends out of the hole, and the extending length is adjusted according to the top neck distance of the aneurysm, so that the distal end is ensured to be fixed in the anatomical center of the aneurysm;
5-2, pushing and pulling the microcatheter to enable the microcatheter to run towards a tangent line at the bending part of the bonding die main body; the microcatheter and the mold body were secured for heated molding.
The step S3 specifically comprises the following steps:
3-1, screening aneurysms and proximal parent carrying arteries, wherein the length of the parent carrying arteries is more than or equal to 3cm, and performing smoothing treatment on burr noise points generated by scanning to generate a model D01;
3-2, removing 1/2-1/3 of the tumor body diameter of the tumor body according to the requirement, 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 the printable model G01.
In the step 3-2, a shell F01 with a certain thickness is prepared by combining the model E01, wherein the thickness of the shell is determined according to the toughness and the transparency of the printing material and is not less than 0.5mm and not more than 0.1mm; and opening holes at the aneurysm or neck of the shell F01 according to the molding requirement of the microcatheter, wherein the diameter of the holes is set to be 0.05-0.2 mm larger than the diameter of the molding catheter.
For the shell F01, the grooves are formed along the trend of the tumor-bearing artery, and the grooves pass through the wall of the blood vessel on the opposite side of the hemangioma, so that the microcatheter is convenient to put in; grooving to avoid protruding parts passing through the bending of blood vessels so as to prevent the micro-catheter from being ejected, and uniformly arranging ventilation holes with the diameter of 0.5-1mm at the periphery of the micro-catheter so as to accelerate the steam or hot water to pass through; when the length of the tumor-bearing artery is too short, a handle with the length of 1 cm to 3cm is added at the proximal end so as to be convenient for 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 die main body is not less than five positions.
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 the step S5, the specific steps of heating plasticity are as follows: placing the hot water bath with the temperature of more than 80 ℃ for 10-30 seconds in cold water for cooling and shaping.
Example 2:
a method for preparing a microcatheter shaping auxiliary die for an aneurysm interventional operation, which is characterized by comprising the following steps of:
s1, contrast: obtaining a blood vessel image original data packet A01 of focal aneurysms and aneurysm-carrying artery images through radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01; the method comprises the steps of carrying out a first treatment on the surface of the
S3, processing a die: processing the 3D mathematical model B01 by using 3D modeling software to generate a molding die file C01;
s4, 3D printing and processing: using a printer to select transparent photosensitive resin which can resist high temperature of 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to carry out increasing support and slicing treatment on a printable model G01 of a molding die file C01, leading the slicing thickness to be 0.05-0.1mm, and leading the slice into the printer for printing; after printing, cleaning by using a cleaning agent matched with resin, heating, solidifying, removing supports, and polishing sharp parts to obtain a die E01.
S5, placing and shaping the microcatheter:
5-1, after the microcatheter is disinfected, the microcatheter is placed in the die body along the slot, the distal end extends out of the hole, and the extending length is adjusted according to the top neck distance of the aneurysm, so that the distal end is ensured to be fixed in the anatomical center of the aneurysm;
5-2, pushing and pulling the microcatheter to enable the microcatheter to run towards a tangent line at the bending part of the bonding die main body; the microcatheter and the mold body were secured for heated molding.
The step S3 specifically comprises the following steps:
3-1, screening aneurysms and proximal parent carrying arteries, smoothing burr noise points generated by scanning to generate a model D01,
3-2, removing 1/2-1/3 of the tumor body diameter of the tumor body according to the requirement, 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 the printable model G01.
In the step 3-2, a shell F01 with a certain thickness is prepared by combining the model E01, wherein the thickness of the shell is determined according to the toughness and the transparency of the printing material and is not less than 0.5mm and not more than 0.1mm; and opening holes at the aneurysm or neck of the shell F01 according to the molding requirement of the microcatheter, wherein the diameter of the holes is 0.05-0.2 mm larger than that of the microcatheter.
For the shell F01, a model F03 is formed by slotting along the trend of the tumor-bearing artery, and the slotting passes through the wall of a blood vessel on the opposite side of the hemangioma, so that the microcatheter is convenient to put in; the open slot is continuously opened from the proximal end to the distal end, is spirally or moderately bent, and avoids passing through the protruding part of the vascular bending so as to prevent the microcatheter from being ejected; ventilation holes with the diameter of 0.5-1mm are uniformly formed in the periphery of the micro-catheter, so that steam or hot water can be accelerated to pass through; when the length of the tumor-bearing artery is too short, a handle with the length of 1 cm to 3cm is added at the proximal end so as to be convenient for 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 die main body is not less than five positions.
In the step S4, the organic solvent is absolute alcohol or isopropanol, and is placed at a sunlight (summer) drying place for 6-8 hours during solidification.
In the step S5, the specific step of heating plasticity is to fumigate for 10-30 seconds by steam and then cool water for cooling and shaping.
Based on the steps, the invention supports the shaping of complex shapes, the invention can bend more than 5 times as required, and the stability and the accuracy of catheter placement 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 the catheter to achieve the shape conforming to the habit of doctors.
Operable to: the continuous open slot allows for easier placement of the microcatheter, and allows for faster access to the interior of the aneurysm mold than insertion from the proximal end through several tortuosity, the serpentine slot avoiding ejection after placement of the microcatheter.
The foregoing is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art, who is within the scope of the present invention, should make equivalent substitutions or modifications according to the technical scheme of the present invention and the inventive concept thereof, and should be covered by the scope of the present invention.
Claims (9)
1. The auxiliary mould for the shape shaping of the microcatheter for the aneurysm interventional operation is characterized by comprising a transparent mould main body, wherein an inner space which is completely matched with a carrying aneurysm extending along the arterial axis is arranged in the mould main body, the aneurysm on the carrying aneurysm is positioned in the inner space, the inner space is used for placing the microcatheter, a hole which is used for penetrating the microcatheter is arranged on the mould main body close to the aneurysm, and the diameter of the hole is larger than the diameter of the shaped microcatheter by 0.05mm-0.2mm; a slot communicating with the outside is arranged on the die main body, and the slot is configured to allow the microcatheter to be laterally placed in the inner space; wherein the slot is formed in a spiral shape around the arterial axis.
2. The microcatheter shaping aid of claim 1, wherein the die body is formed in a tubular shape extending along an arterial axis, having a proximal end and a distal end, the slot extending continuously from the proximal end to the distal end.
3. A method for preparing the micro-catheter shaping auxiliary die for the aneurysm intervention operation, which is characterized by comprising the following steps:
s1, contrast: obtaining a blood vessel image original data packet A01 of focal aneurysms and aneurysm-carrying artery images through radiography;
s2, 3D reconstruction: modeling the original data packet by using 3D reconstruction software to obtain a 3D mathematical model B01;
s3, processing a die: processing the 3D mathematical model B01 by using 3D modeling software to generate a molding die file C01;
s4, 3D printing and processing: using a printer to select transparent photosensitive resin which can resist high temperature of 100 ℃ and does not deform and release toxic substances, using self-contained slicing software of the printer to carry out increasing support and slicing treatment on a printable model G01 of a molding die file C01, leading the slicing thickness to be 0.05-0.1mm, and leading the slice into the printer for printing; after printing, cleaning by using a cleaning agent, heating, solidifying, removing supports, and polishing sharp parts to obtain a die main body E01;
s5, placing and shaping the microcatheter:
5-1, after the microcatheter is sterilized, the microcatheter is placed into the die main body along the side direction of the slot, the distal end extends out of the hole, and the extension length is adjusted according to the top neck distance of the aneurysm, so that the distal end of the die main body is ensured to be fixed at the anatomical center of the aneurysm;
5-2, pushing and pulling the microcatheter to enable the microcatheter to run towards a tangent line at the bending part of the bonding die main body; fixing the microcatheter and the mould main body well for heating and shaping;
in the step 5-2, the bending position of the die main body is not less than five positions.
4. A method according to claim 3, wherein said step S3 is specifically:
3-1, screening aneurysms and proximal parent carrying arteries, smoothing burr noise points generated by scanning to generate a model D01,
3-2, removing 1/2-1/3 of the aneurysm body diameter of the aneurysm or all the aneurysm body diameters as required, exposing the anatomical center or the position nearby the aneurysm to obtain a model E01, uniformly generating a shell F01 with a certain thickness by the model E01, and finally outputting the printable model G01.
5. The method according to claim 4, wherein in said step 3-2, in combination with the mold E01, a shell F01 having a thickness determined according to the toughness and transparency of the printing material is prepared, the thickness of the shell being not less than 0.5mm and not more than 0.1mm; and opening holes at the aneurysm or neck of the shell F01 according to the molding requirement of the microcatheter, wherein the diameter of the holes is set to be 0.05-0.2 mm larger than that of the molding catheter.
6. A method according to claim 3, wherein for the housing F01, a slit is formed along the course of the parent artery, which is continuously open from the proximal end to the distal end, and which is helically curved and passes over the wall of the vessel opposite the aneurysm for facilitating microcatheter placement; grooving to avoid protruding parts passing through the bending of blood vessels so as to prevent the micro-catheter from being ejected, and uniformly arranging ventilation holes with the diameter of 0.5-1mm at the periphery of the micro-catheter so as to accelerate the steam or hot water to pass through; when the length of the tumor-bearing artery is too short, a handle with the length of 1 cm to 3cm is added at the proximal end so as to be convenient for clamping and fixing during heating; the printable model G01 is finally output.
7. A method according to claim 3, wherein said step S1 employs digital subtraction angiography.
8. A method according to claim 3, wherein in step S4, the cleaning agent is absolute alcohol or isopropyl alcohol, the curing temperature is 80-100 ℃, the curing time is 1 minute, or the cleaning agent is placed at a solar drying place for 6-8 hours.
9. A method according to claim 3, wherein in said step S5, the specific step of heat shaping is: placing the hot water bath with the temperature of more than 80 ℃ for 10-30 seconds in cold water for cooling and shaping; or steaming for 10-30 seconds, cooling with cold water, and shaping.
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