CN106823121B - Degradable radioactive particle chain with shape memory function - Google Patents
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- CN106823121B CN106823121B CN201710060228.3A CN201710060228A CN106823121B CN 106823121 B CN106823121 B CN 106823121B CN 201710060228 A CN201710060228 A CN 201710060228A CN 106823121 B CN106823121 B CN 106823121B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1007—Arrangements or means for the introduction of sources into the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1014—Intracavitary radiation therapy
Abstract
The invention relates to a radioactive brachytherapy device, in particular to a degradable radioactive particle chain with a shape memory function. The degradable radioactive particle chain comprises at least one radioactive particle and a wrapping layer; the radioactive particles are radioactive sources, and at least one part of the radioactive particles is wrapped by the wrapping layer; the wrapping layer material comprises polycaprolactone PCL. The particle chain made of PCL as a main forming material has a shape memory function, so that the implantation operation of the particle chain is simple, a certain supporting force can be kept on the lumen and the gland at the same time, and the normal physiological functions of the lumen and the gland are not influenced after the implantation operation of the particle chain is ensured; meanwhile, PCL has the advantages of biodegradability, low melting point and the like.
Description
Technical Field
The invention relates to a radioactive brachytherapy device, in particular to a degradable radioactive particle chain with a shape memory function.
Background
Malignant tumors are serious diseases threatening human health, and the near-distance treatment of tumors among tissues by radioactive particles is a new technology developed in recent decades. The radioactive particles are small radioactive sources, which contain radioactive isotopes in a titanium tube, the two ends of which are welded by laser or electron beam technology to form a sealed source, the size of which is generally 0.8mm in outside diameter and 4.5mm in length. Nuclides commonly used for radioactive particles are192Ir、198Au、169Y、131Cs、103Pd and125i, etc., especially103Pd and125I. the radioactive particles are directly implanted into the focus for close range continuous irradiation to destroy the DNA double bond of the tumor cell nucleus, kill or sublethal tumor cells and lose the replication capacity, so that the treatment purpose is achieved.
The radioactive particle tissue-tissue implantation treatment of tumor is a very effective treatment means, has the advantages of high tumor inhibition efficiency, reasonable dose distribution, convenient coordination with operation to form complementation and the like, but also has the defects of displacement in tissue after radioactive particle implantation, complicated particle implantation operation and the like. Radioactive particle chains are a new technology emerging from radioactive particle brachytherapy applications, namely, various components such as radioactive particles and image markers are assembled into the particle chains through a biocompatible material (especially biodegradable) through a physical or chemical method.
The use of chains of radioactive particles has the following advantages: (1) migration situations do not occur due to posture change or tumor body deformation after the radioactive particle chain is implanted, and the particle dose distribution meets the source distribution dose requirement of a Treatment Planning System (TPS). (2) The indications of radioactive particle implantation are increased, especially in the case that loose tissues exist at the tumor site, for example, a large number of glands exist at the tumor site, and the implantation site is not suitable for single particle implantation. (3) The chains of radioactive particles generally have good elastic and mechanical properties, which allow a compliant deformation as the tumor tissue shrinks. (4) The molding material of the radioactive particle chain is generally made of biocompatible materials (particularly biodegradable materials), the biodegradation time of the material is a plurality of weeks, the period is equivalent to the atrophy period of tumors after the tumors receive radiation of radioactive particles, and normal tissues are not affected after the treatment is finished. (5) The radioactive particle chain uses a molding material which prevents the radioactive particles from directly contacting the tumor tissue, thus avoiding the phenomenon of necrosis of local tissue due to overdose. (6) The particle chain is implanted through the implantation system, so that the layout of a plurality of radioactive particles can be realized at one time, and the implantation operation time and the irradiation dose of medical personnel are reduced. (7) The assembly of the radioactive particle chain is finished by a manufacturer, so that convenience is brought to users, and the added value of products is improved.
The inventor of the present invention previously invented a chinese patent named "a radioactive particle chain" with application publication number CN103736201A proposes a particle chain wrapped with hydrophilic alginate as a molding material, which can be rapidly softened in a humid environment in vivo after implantation, and finally deformed and finally degraded with the shrinkage of tumor tissue, but the particle chain lacks sufficient supporting force after in vivo softening, and is only suitable for implantation in a tumor with high tissue density, and for a tumor with a large number of lumen and gland parts, the particle chain is easy to displace, resulting in dose deviation.
In view of the above-mentioned drawbacks, the present inventors have finally obtained the present creation through long-term research and practice.
Disclosure of Invention
In view of the problems of the background art, it is an object of the present invention to provide a degradable radioactive particle chain with shape memory function, so as to overcome the above technical drawbacks.
In order to achieve the purpose, the invention provides the following technical scheme:
a degradable radioactive particle chain with a shape memory function comprises at least one radioactive particle and a wrapping layer;
the radioactive particles are radioactive sources, and at least one part of the radioactive particles is wrapped by the wrapping layer;
the wrapping layer material comprises polycaprolactone PCL.
Further, the wrapping material may further comprise a filler and/or a plasticizer.
Further, the filler comprises an inorganic filler and a polymer filler, and the filler accounts for no more than 20% of the specific gravity of the wrapping layer;
the plasticizer comprises a natural or synthetic liquid ester material, and accounts for no more than 10% of the weight of the wrapping layer.
Further, the inorganic filler is one or more of calcium carbonate, calcium sulfate, hydroxyapatite, carbon black, silicon nitride and aluminum hydroxide;
the polymer filler is one or more of polylactic acid, polyglycolic acid, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, starch and cellulose;
the plasticizer is one or more of tributyl citrate, acetyl tributyl citrate, glycerol triacetate, castor oil and coconut oil.
Further, the degradable radioactive particle chain also comprises at least one spacer component, and at least one part of the spacer component is wrapped in the wrapping layer.
Further, the spacer member material is a biocompatible material.
Further, the degradable radioactive particle chain also comprises a component with the functions of anchoring the position of the radioactive particle chain and/or labeling and/or isolating.
Furthermore, the degradable radioactive particle chain is in any one structure of a linear shape, an arc shape, a ring shape, a spiral shape, a forked shape, a cross shape and a net shape or a combined structure of any plurality of particle chains.
The invention has the beneficial effects that:
the invention adopts the degradable material PCL with the shape memory function as the molding material, and the particle chain made by taking the PCL as the main molding material has the following advantages:
1. the PCL has a shape memory function, so that the implantation operation can be completed once through a puncture needle for particle chains with different shapes, particularly for tumors with complicated positions, and the implantation operation of the particle chains is simplified when the particle chains with curved shapes need to be used.
2. The PCL has the shape memory function to provide enough supporting force in different directions, especially for tumors near the lumen and gland parts of a human body, and the particle chain made of PCL as a main molding material can simultaneously maintain certain supporting force for the lumen and the gland, especially for the particle chain in a spiral shape or other complex shapes, has stronger supporting force for the axial direction of the chain, and ensures that the normal physiological functions of the lumen and the gland are not influenced after the particle chain is implanted into a surgery.
3. The PCL has biodegradability, and when radioactive doses in particle chains are basically released, the PCL is synchronously degraded through the adjustment of different molecular weight ratios and components such as fillers for accelerating degradation.
4. The PCL has low melting point of about 60 ℃, and is suitable for medical staff to adjust the shape and the layout of a particle chain before and even during surgery so as to deal with various conditions occurring during surgery.
5. The particle chains of PCL as the main molding material may form a combined structure of a plurality of particle chains as required.
Drawings
Fig. 1 is a schematic structural view of a linear particle chain in which a part of radioactive particles is wrapped by a wrapping layer.
Fig. 2 is a schematic structural view of a linear particle chain in which radioactive particles are completely encapsulated by an encapsulation layer.
Fig. 3 is a schematic structural view of a linear particle chain including spacer members.
Fig. 4 is a schematic structural view of a linear particle chain in which a space exists between the components.
Fig. 5 is a schematic structural view of a cross-shaped particle chain.
Fig. 6 is a schematic structural view of an annular particle chain.
Fig. 7 is a schematic structural view of a circular arc-shaped particle chain.
Fig. 8 is a schematic external view of a particle chain with an anchor assembly.
In the figure, 1-radioactive particle, 2-cladding, 3-spacer element, 4-anchor element.
Detailed Description
The invention provides a degradable radioactive particle chain with a shape memory function, which comprises at least one radioactive particle and a wrapping layer.
The radioactive particles are radioactive sources and at least one part of the radioactive particles is wrapped by the wrapping layer.
Fig. 1 is a schematic structural view of a linear particle chain in which a part of radioactive particles is wrapped by a wrapping layer.
Fig. 2 is a schematic structural view of a linear particle chain in which radioactive particles are completely encapsulated by an encapsulation layer.
The wrapping material comprises PCL.
Polycaprolactone, PCL for short, is a thermoplastic semi-crystalline polyester usually obtained by ring-opening polymerization of epsilon caprolactone monomers. The PCL has a melting point of 59-64 ℃, a glass transition temperature of-60 ℃, and a structural repeating unit of the PCL is provided with 5 nonpolar methylene groups and one polar ester group, so that the PCL has good flexibility and processability, and the prepared particle chain has shape memory and biodegradability.
The material of the wrapping layer may also include fillers and/or plasticizers.
The filler comprises inorganic filler and polymer filler, and can reduce the cost, improve the mechanical property of the wrapping layer material and adjust the degradation time of the wrapping layer in vivo. The inorganic filler is any one or a mixture of any several of calcium carbonate, calcium sulfate, hydroxyapatite, carbon black, silicon nitride and aluminum hydroxide in any proportion, the polymer filler is any one or a mixture of any several of polylactic acid, polyglycolic acid, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, starch and cellulose in any proportion, and the filler accounts for no more than 20% of the weight of the coating layer.
The plasticizer comprises a natural or synthetic liquid ester material, has good compatibility with PCL, and can adjust the toughness of the wrapping layer. The plasticizer is any one or a mixture of any several of tributyl citrate, acetyl tributyl citrate, triacetin, castor oil and coconut oil in any proportion, and the proportion of the plasticizer in the wrapping layer is not more than 10%.
As shown in fig. 3, the degradable radioactive particle chain may further include at least one spacer component, at least a portion of the spacer component is wrapped in the wrapping layer for optimizing the radioactive particle radiation dose and improving the mechanical properties of the radioactive particle chain, and the spacer component is made of a biocompatible material.
The degradable radioactive particle chain is in any one structure of a linear shape, a circular arc shape, a ring shape, a spiral shape, a forked shape, a cross shape and a reticular shape or a combined structure of any plurality of particle chains. Fig. 5 is a schematic structural view of a cross-shaped particle chain, fig. 6 is a schematic structural view of a ring-shaped particle chain, and fig. 7 is a schematic structural view of a circular arc-shaped particle chain.
The degradable radioactive particle chains can also comprise components with the functions of anchoring the position of the radioactive particle chains and/or labeling and/or isolating.
The anchor assembly is used to fix the position of the chain of particles, typically a protrusion, and can be located on any surface of the chain of particles to ensure that the chain of particles does not become displaced within the tissue after implantation, as shown in fig. 8. The markers are opaque materials such as X-ray or CT, and are used for marking the positions of the particle chains by means of X-ray, ultrasound, CT and the like in the operation, and the markers can be marked at the two ends of the particle chains and also can be marked in the gaps between every two adjacent radioactive particles.
The quality control of the particle chain made of PCL as the main molding material mainly comprises the following steps:
1. and (3) appearance detection: the prepared radioactive particle chain taking PCL as a main molding material has uniform appearance, uniform arrangement of radioactive particles and uniform spacing distance.
2. And (3) testing the puncture needle: the linear, circular or other curved particle chains pass through the 18-gauge puncture needle without obvious resistance, and the radioactive particle chains are kept complete after passing through.
3. And (3) testing mechanical stability: the two ends of the radioactive particle chain (whatever shape) are placed on the two wood boards, the middle of the chain is suspended, the radioactive particle chain is not deformed due to self weight, and no deformation can be seen by naked eyes after the weight of the chain is 0.1 g, which shows that the mechanical property of the radioactive particle chain is stable.
4. Testing the shape memory performance: the radioactive particle chain is deformed by applying a certain external force, and returns to the original shape after the external force is removed, and the concrete expression is that the arc-shaped or other curve-shaped particle chains can restore to the original shape after passing through a number 18 puncture needle head, both ends of the radioactive particle chain (in any shape) are placed on two wood boards, the middle of the radioactive particle chain is suspended, the chain deforms after bearing a load of 2 grams, the particle chain restores to the original shape after the load is removed, for the spiral particle chain, the particle chain is suspended, the load is applied to the bottom, the elastic stretching is performed when the load is 2 grams, the spiral diameter is reduced, and the spiral particle chain restores to the original shape when the load is removed.
5. And (4) testing the storage stability performance: the manufactured radioactive particle chain is stored in a sealed manner at 4 ℃ and room temperature for one month, and then an external observation test, a puncture needle test, a mechanical property test and a shape memory property test are carried out, so that the results show that the properties are not obviously changed during the storage period.
6. And (3) testing the biodegradation performance: the radioactive particle chain is put into physiological saline at 37 ℃, the standard that the particles in the particle chain are scattered and are not in a chain shape any more and the molding material is broken into fragments is taken as the complete degradation standard, the test result shows that the degradation time of the radioactive particle chain made by using PCL as the main molding material is 10 months, and the requirement of clinical application is met.
Preparing and molding PCL: the material with different shapes and specifications can be manufactured by conventional means such as injection molding, extrusion, solution casting evaporation method and the like.
The preparation of the particle chain made of PCL as the main molding material is completed by the following steps:
1. manufacturing a pipe:
PCL is mixed with a filler and a plasticizer and then is made into a PCL pipe in an extrusion mode, or the PCL pipe is directly made into a pipe by using a pipe mold, the inner diameter of the pipe is matched with the outer diameter of radioactive particles, the outer diameter of the radioactive particles is generally 0.8mm, the inner diameter of the pipe is 0.8mm-1.2mm, the radioactive particles cannot be loaded if the inner diameter of the pipe is too small, the inner diameter of the pipe is too large, and the loading position of the radioactive particles is easy to shift; the wall thickness of the pipe is 0.05mm-2mm, the mechanical supporting force of the particle chain is insufficient due to the thin pipe wall, the cost is increased due to the thick pipe wall, and the particle chain is not suitable for being implanted by using a puncture needle. After the pipe is formed, the pipe can be cut into proper lengths according to requirements.
2. Loading of radioactive particles:
according to the requirements designed in advance, the radioactive particles, the markers, the spacers and other components are sequentially loaded into the PCL tube, and the components can be sequentially loaded without intervals, as shown in FIG. 1, or a single component can be loaded into a preset position in the PCL tube, and the components can have intervals, as shown in FIG. 4. The loading mode can be that the components are sequentially pushed into a preset position in the pipe by a push rod, wherein the diameter of the push rod is smaller than the inner diameter of the pipe, or the corresponding components are sequentially inserted into the pipe without gaps, and the components sequentially slide into the preset position in the insertion process.
3. Molding:
placing the PCL tube into a mold with a preset shape, heating to a temperature of not less than 60 ℃, preferably 60-100 ℃, optimally 70 ℃ to melt the PCL tube, cooling, and demolding to obtain the PCL tube. The PCL tube is formed quickly, the heating time is 1 second to 10 minutes, preferably 10 seconds to 1 minute, and most preferably 20 seconds, and the forming process can be completed. The molding process can be repeated for many times, and a plurality of particle chains can be assembled to form a complex particle chain structure.
The particle chain preparation method using PCL as the main molding material has the following advantages:
1. the manufacturing process is simple and convenient, and the product can be formed only by once heating.
2. The preparation process is convenient, complex equipment is not needed, the preparation time is short, and the operation can be carried out on the operation site.
3. The manufactured product can be repeatedly heated/cooled and formed.
4. The particle chains made of PCL as main molding material can be spliced, woven, fused and cut into different shapes and different functional particle chain combinations to adapt to complex clinical conditions.
To facilitate a further understanding of the invention, the following examples are provided to illustrate it in more detail. These examples are given solely for the purpose of illustration and are not intended to limit the scope or the principles of the invention, which is defined by the claims and include obvious variations or modifications based thereon.
Example 1:
manufacturing a pipe: PCL (molecular weight 50000) is independently added into an extruder to prepare a pipe with the inner diameter of 0.8mm and the wall thickness of 0.2 mm.
Loading of radioactive particles: 10 particles with an outer diameter of 0.8mm and a length of 4.5mm125I radioactive particles are sequentially loaded into the PCL tube without gaps between the particles.
Molding: will be filled into125I PCL tube of radioactive particles is heated to 70 ℃ on a heating plate, the heating is stopped after the tube wall becomes transparent, and linear particle chains are formed after cooling.
The prepared radioactive particle chain is detected, the appearance is linear and the surface is uniform, the chain can smoothly pass through a 18-gauge puncture needle head, two ends of the radioactive particle chain are placed on two wood boards, the middle of the chain is suspended, the radioactive particle chain is not deformed due to self weight, and the chain still has no visible deformation after the load is 0.1 g in the middle of the chain, so that the mechanical property of the radioactive particle chain is stable, the chain is obviously bent and deformed after the load is 2 g in the middle of the chain, and the chain is restored to be linear after the load is removed, so that the radioactive particle chain has the shape memory function.
Example 2:
manufacturing a pipe: PCL (molecular weight of 50000), PLA (polylactic acid, molecular weight of 5000) and acetyl tributyl citrate are added into an extruder according to the weight ratio of 80:19:1 to prepare a pipe with the inner diameter of 0.8mm and the wall thickness of 0.2 mm.
Loading of radioactive particles: 10 particles with an outer diameter of 0.8mm and a length of 4.5mm125I radioactive particles are sequentially loaded into the PCL tube without gaps between the particles.
Molding: will be filled into125Heating the PCL tube of the I radioactive particles in an arc-shaped tubular mold, stopping heating after 20 seconds, cooling, and demolding to form an arc-shaped particle chain.
The prepared radioactive particle chain is detected, the appearance is arc-shaped, the surface is uniform, the chain can smoothly pass through the 18-gauge puncture needle head, and the arc-shaped shape is still maintained after the chain passes through the puncture needle. The radioactive particle chain is hung, the radioactive particle chain is not deformed due to self weight, the arc shape is still maintained, no deformation can be seen by naked eyes after the bottom of the chain bears a load of 0.1 g, the mechanical property of the radioactive particle chain is stable, the radioactive particle chain is obviously bent and deformed after the load of 2 g, the arc shape is straightened, and the radioactive particle chain is restored to the arc shape after the load is removed, so that the shape memory function of the radioactive particle chain is realized.
Example 3:
manufacturing a pipe: PCL (molecular weight of 50000), nano calcium carbonate and acetyl tributyl citrate are added into an extruder according to the weight ratio of 90:5:5 to prepare a pipe with the inner diameter of 0.8mm and the wall thickness of 1 mm.
Loading of radioactive particles: 20 particles with an outer diameter of 0.8mm and a length of 4.5mm125I radioactive particles are sequentially filled into a PCL tube, and the interval between every two particles is 2 mm.
Molding: will be filled into125I PCL tube of radioactive particles is wound into a spiral shape on a heating rod heated to 70 ℃ and with the diameter of 10mm, the heating is stopped after the winding is finished, and a spiral particle chain is formed after demoulding.
The radioactive particle chain prepared is detected, the appearance is spiral, the surface is uniform, the radioactive particle chain is suspended, the radioactive particle chain is not deformed due to self weight, the spiral is still maintained, no macroscopic deformation is generated after 0.1 g of load is carried at the bottom of the chain, the mechanical property of the radioactive particle chain is stable, obvious tensile deformation is generated after 2 g of load is carried, the spiral is straightened, the diameter of the spiral is reduced, the spiral is restored after the load is removed, the radioactive particle chain has a shape memory function, the radial support similar to a spring is provided, the resilience performance is realized, and the radioactive particle chain is suitable for implantation of radioactive particles in a lumen.
Example 4:
manufacturing a pipe: PCL (molecular weight of 50000), thermoplastic starch and acetyl tributyl citrate are added into an extruder according to the weight ratio of 80:15:5 to prepare a pipe with the inner diameter of 0.8mm and the wall thickness of 1 mm.
Loading of radioactive particles: 20 particles with an outer diameter of 0.8mm and a length of 4.5mm125I radioactive particles are sequentially filled into a PCL tube, and the interval between every two particles is 2 mm.
Molding: will be filled into125I PCL tube of radioactive particles is heated to 70 ℃ on a heating plate, the heating is stopped after the tube wall becomes transparent, and linear particle chains are formed after cooling. And placing the two formed particle chains on a heating plate, overlapping the two formed particle chains in a crossed manner to form a cross shape, heating the particle chains to 70 ℃, forming the particle chains again, and cooling the particle chains to form the cross-shaped particle chains.
The radioactive particle chains thus obtained were examined to have a cross-like appearance and a uniform surface, and the examination method and the results of one single particle chain in the cross-like particle chains were the same as in example 1.
Claims (4)
1. A degradable radioactive particle chain with a shape memory function is characterized in that: the degradable radioactive particle chain comprises at least one radioactive particle and a wrapping layer;
the radioactive particles are radioactive sources, and at least one part of the radioactive particles is wrapped by the wrapping layer;
the wrapping layer material comprises Polycaprolactone (PCL);
the wrapping material further comprises a filler and/or a plasticizer;
the degradable radioactive particle chain further comprises at least one spacer component, and at least one part of the spacer component is wrapped in the wrapping layer;
the degradable radioactive particle chain also comprises a component with the functions of anchoring the position of the radioactive particle chain and/or labeling and/or isolating;
the degradable radioactive particle chain is in any one structure of a linear shape, a circular arc shape, a ring shape, a spiral shape, a forked shape, a cross shape and a reticular shape or a combined structure of any plurality of particle chains.
2. The degradable radioactive particle chain with shape memory function of claim 1, wherein:
the filler comprises an inorganic filler and a polymer filler, and the filler accounts for no more than 20% of the specific weight of the wrapping layer;
the plasticizer comprises a natural or synthetic liquid ester material, and accounts for no more than 10% of the weight of the wrapping layer.
3. The chain of degradable radioactive particles with shape memory function according to claim 2, wherein:
the inorganic filler is one or more of calcium carbonate, calcium sulfate, hydroxyapatite, carbon black, silicon nitride and aluminum hydroxide;
the polymer filler is one or more of polylactic acid, polyglycolic acid, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, starch and cellulose;
the plasticizer is one or more of tributyl citrate, acetyl tributyl citrate, glycerol triacetate, castor oil and coconut oil.
4. The degradable radioactive particle chain with shape memory function of claim 1, wherein: the spacer member material is a biocompatible material.
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| US20050245785A1 (en) * | 2003-10-29 | 2005-11-03 | Tarone Theodore T | Biodegradable seed placement device and method |
| CN1887364A (en) * | 2006-07-20 | 2007-01-03 | 中国科学院长春应用化学研究所 | Biodegradable medical extracorporeal fixing material possessing shape memory function |
| CN103301561A (en) * | 2012-03-16 | 2013-09-18 | 吴沛宏 | High-flexibility radioactive particle and implanting method thereof |
| WO2014205076A1 (en) * | 2013-06-20 | 2014-12-24 | Source Production & Equipment Co., Inc. | Radioactive therapeutic device with fixation |
| CN103736201B (en) * | 2013-12-31 | 2016-01-20 | 原子高科股份有限公司 | A kind of radioactive particle chain |
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