CN117064604A - Human body cavity inner support with radioactivity - Google Patents

Human body cavity inner support with radioactivity Download PDF

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Publication number
CN117064604A
CN117064604A CN202311085314.1A CN202311085314A CN117064604A CN 117064604 A CN117064604 A CN 117064604A CN 202311085314 A CN202311085314 A CN 202311085314A CN 117064604 A CN117064604 A CN 117064604A
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CN
China
Prior art keywords
stent
cavity
radioactive
yttrium
medicine carrying
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CN202311085314.1A
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Chinese (zh)
Inventor
姜培齐
桑宏勋
张萍
宋国安
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Individual
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Individual
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Priority to CN202311085314.1A priority Critical patent/CN117064604A/en
Publication of CN117064604A publication Critical patent/CN117064604A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002Intraluminal radiation therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007Arrangements or means for the introduction of sources into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1014Intracavitary radiation therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0095Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof radioactive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N2005/1019Sources therefor
    • A61N2005/1024Seeds

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

The invention provides a radioactive human body intra-cavity support, which comprises a support main body with a tubular structure, wherein a medicine carrying cavity is arranged in the support main body, and radioactive yttrium-90 particles are loaded in the medicine carrying cavity. The support is of a tubular structure, radioactive particles yttrium-90 are loaded in the medicine carrying cavity, the cavity can be opened in a manner of erecting the support in vivo, the problems of blockage and stenosis are solved, yttrium-90 can be fixed on the surface of cancer tissue cells, and accurate radioactive treatment can be performed in a local orientation, so that the treatment effect is improved, and meanwhile, the side effect of the radioactive treatment is reduced.

Description

Human body cavity inner support with radioactivity
Technical Field
The invention relates to the technical field of medical appliances, in particular to a radioactive human body cavity inner support.
Background
A common problem that is clinically manifested is blockage when cancer is present in the human body's prostate, liver/bile duct, esophagus, duodenum, trachea, colon, rectum, etc. or when prostate hyperplasia occurs. At present, the medical stent is widely applied to clinical treatment of the stenosis of the cavity, but the common medical stent only supports the stenosed cavity by the supporting force of the stent, plays a certain role in relieving, but has higher restenosis probability along with the growth of the tumor.
Yttrium-90 is a medical isotope, which is mainly applied to the treatment of malignant tumors such as liver cancer, lymph cancer, pancreatic cancer and the like, and beta rays emitted by the medical isotope have cytotoxicity on the tumors, but have weak tissue penetrating power, so the damage to other normal tissues is very small.
At present, yttrium-90 is mainly used by a microsphere injection method, namely yttrium-90 resin or glass microspheres loaded with beta rays are selectively injected into hepatic artery, and the microspheres are blocked on tumor vascular beds along with blood flow, so that local treatment of liver malignant tumors is realized. The injection method has remarkable effect on treating liver cancer, but is not fully applicable to cancer cells of other cavities in a human body, and the degree of blockage of microspheres in blood flow is different due to the different sizes and actual blockage degrees in different cavities, so that yttrium-90 is difficult to control by microsphere injection to realize targeted local accurate treatment on tumors of the cavities of the human body.
In view of this, the present invention has been made.
Disclosure of Invention
The invention aims to provide a radioactive human body intra-cavity support which is of a tubular structure, radioactive particles yttrium-90 are loaded in a medicine carrying cavity, and the support is erected in a body, so that the cavity can be opened, the problems of blockage and stenosis can be relieved, yttrium-90 can be fixed on the surface of cancer tissue cells, and accurate radioactive treatment can be performed on local orientation, so that the treatment effect is improved, and meanwhile, the side effect of the radioactive treatment is reduced.
In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:
the invention provides a radioactive human body intra-cavity support, which comprises a support main body with a tubular structure, wherein a medicine carrying cavity is arranged in the support main body, and radioactive yttrium-90 particles are loaded in the medicine carrying cavity.
Because the tissue penetrating power of yttrium-90 is very weak, through loading radioactive particles yttrium-90 on the stent main body, and then putting the stent main body into the body and directly attaching the stent main body to the tumor, the accurate internal radiotherapy of yttrium-90 on the tumor can be realized, the radiotherapy effect is improved to the greatest extent, and the influence of radioactive particles on other normal tissues is reduced. On the other hand, the stent body is designed into a tubular structure, so that the lumen blocked by the tumor can be opened, and the problem of lumen stenosis is relieved.
Preferably, the medicine carrying cavity is also loaded with radioactive particles strontium-90 and iodine-125, and the radioactive particles are distributed in layers in the medicine carrying cavity;
wherein the radioactive particle strontium-90 is arranged at the left edge and the right edge of the medicine carrying cavity, and the radioactive particle yttrium-90 and the iodine-125 are arranged at the middle part of the medicine carrying cavity, wherein the radioactive particle yttrium-90 accounts for 50% -90% of the total mass.
Preferably, the medicine carrying cavity is also loaded with radioactive particles strontium-90 and iodine-125, and the radioactive particles yttrium-90, strontium-90 and iodine-125 are uniformly mixed, wherein the radioactive particles yttrium-90 accounts for 50% -90% of the total mass.
Since tumor tissue in a human body is often a tumor cell complex with different differentiation degrees, a single radioactive particle has limited effect, and in order to achieve a better therapeutic effect, radioactive particles with different properties are used in combination. The invention can be matched with strontium-90 and iodine-125 to adjust the effect of radiotherapy besides radioactive particle yttrium-90.
Wherein, strontium-90 and yttrium-90 both emit beta rays to form ionization, strontium-90 is decayed into yttrium-90 through beta decay, yttrium-90 is further changed into zirconium (Zr) through beta decay, and beta rays with energy of 0.65 MeV and 2.2MeV are released in the continuous decay processes, wherein, the beta rays with 2.2MeV play a main therapeutic role; on the other hand, the maximum penetration distance of the beta rays of 2.2MeV in the tissue is 11mm, the dose of the beta rays is rapidly reduced along with the increase of the tissue depth, the tissue dose at the 1mm depth is 53 percent, the tissue dose at the 2mm depth is 26 percent, the tissue dose at the 3mm depth is 12 percent, and only 1 percent of the beta rays at the 6mm depth is left, so the beta rays are particularly suitable for the treatment of superficial diseases with a plurality of millimeters, do not damage surrounding and whole organs of a treatment area, and are safe and reliable to use.
In addition, the iodine-125 has different radioactivity from strontium-90 and yttrium-90, has larger killing radius and is more suitable for treating large tumors; the half-lives of strontium-90, yttrium-90 and iodine-125 are also different, the half-life of yttrium-90 is 64h, the half-life of strontium-90 is 46 years, and the half-life of iodine-125 is 60.14 days. Therefore, the invention mixes three radioactive particles of strontium-90, yttrium-90 and iodine-125 for use, and can control the radiotherapy effect and the radiotherapy time by adjusting the contents of various types. The decay energy of yttrium-90 is more suitable for being matched with the stent brachytherapy, so that the content of yttrium-90 is the majority no matter which filling mode is selected.
When the radioactive particles are distributed in a layered manner, the strontium-90 is arranged at the left edge and the right edge, and because the half-life period of the strontium is long and the radiation dose per unit time is small, the small-dose treatment can be carried out on the rest small quantity of tumor cells in the later period so as to prevent recurrence and reduce the damage to normal tissues. The yttrium-90 and the iodine-125 are arranged at the middle part, so that accurate radiotherapy can be better carried out on tumor cells, and the content of the iodine-125 can be properly increased for huge tumor tissues to improve the radiotherapy effect.
In addition, the radioactive particles may be uniformly mixed. Because the properties of the radioactive particles are different, the mixed radioactive particles can play a role in uniformly killing tumor tissues, and are more suitable for tumor cell complexes with different differentiation degrees.
Preferably, the radioactive particles yttrium-90, strontium-90 and iodine-125 are one of powder, paste or drug-loaded microspheres, the particle size of the powder and paste is 0.1-1mm, and the diameter of the drug-loaded microspheres is 10-100 mu m.
When the radioactive particles are powder or paste, the filling mode of alternately and repeatedly arranging the radioactive particles in sequence is more suitable to be selected, and the radioactive particles can be ejected into the medicine carrying cavity by an appliance after the support body is assembled; when the radioactive particles are drug-loaded microspheres, the method is more suitable for selecting a filling mode of uniformly mixing the radioactive particles, and the radioactive particles are injected through an injection needle tube.
Preferably, the bracket main body is integrally formed in a spring tube shape, the total length is 5-150mm, and the bracket main body is made of carbon fiber or flexible glass; the spring tube is hollow to realize the function of the medicine carrying cavity, and the inner diameter of the medicine carrying cavity is 0.1-1mm.
The bracket main body is designed into a spring tube shape, and is made of plastic, carbon fiber or flexible glass, so that the bracket main body has the advantages of small size, thin tube wall, good durability, memory property and elasticity capable of changing shape within a certain range, and soft radial expansion force can be continuously generated when the bracket main body is placed in a human body cavity, so that a narrow part is gradually recovered and unobstructed, and pain and discomfort of a human body are relieved; in addition, when the artificial limb is applied to a cavity with larger peristaltic property such as esophagus, certain deformation can be generated to conform to the peristaltic motion of the artificial limb, and the discomfort of a human body is relieved.
On the other hand, the support main part is integrated into one piece's structure, can transmit the atress well, effectively improves life, prevents the fracture damage.
Preferably, the openings at the upper end and the lower end of the medicine carrying cavity are provided with rubber plugs for sealing, and 2-8X-ray developing tantalum beads are distributed in the rubber plugs and the medicine carrying cavity.
The aim of setting up development tantalum pearl is to realize the development under the perspective of X ray, helps location and observe the condition of placing of support in the body. In addition, tantalum is a corrosion-resistant metal, has good affinity with human tissues and has excellent clinical effect.
Preferably, the surface of the bracket main body contacted with the human body cavity is provided with continuous wavy bulges, and the diameter of the wavy wave crest is 0.1-1mm wider than that of the non-bulge.
The continuous wavy line type bulges on the surface of the support main body can improve the wall grabbing stability during placement, play a limiting role, and prevent that the support from moving to cause radioactive particles to be incapable of accurately carrying out radiotherapy on affected parts.
Preferably, the outer wall of the medicine carrying cavity is also provided with a memory alloy wire which is unfolded into a spring shape when the temperature is above 30 ℃.
Preferably, the memory alloy wire is titanium-nickel alloy.
The memory alloy wire made of the nickel-titanium alloy has the excellent characteristics of shape memory function, wear resistance, corrosion resistance, super elasticity and the like, can meet the application requirements of various projects and medicine, and can automatically restore the plastic deformation of the wire to the original shape at a certain specific temperature. The memory alloy wire is in a softened state in an environment of 0-10 ℃ (or ice water), can be stretched into a straight line, is convenient for filling radioactive particles and putting into a body, and reduces damage to the wall of a cavity channel when putting into the body; in the environment of the human body (the environment temperature is more than 30 ℃), the rigidity can be gradually recovered, the support body is unfolded into a spring shape, and the support body is matched with a support body made of plastic, carbon fiber or flexible glass, so that the memory property and the elasticity of the support body are further improved.
Preferably, the support is used for internal radiotherapy of bone tumor, one end of the support body is connected with a tail wire for extraction, and the tail wire is woven by X-ray development tantalum wires.
The stent main body can also be applied to accurate radiotherapy in bone cancer, after the stent main body is placed in a disease body area, the tail end of the tail fiber is reserved outside the skin, and after the radiotherapy is finished, the stent main body can be directly pulled out of the body through the tail fiber without secondary operation. The fiber is woven by the development tantalum wire, so that development is realized under the perspective of X rays, and positioning and observation of the placement condition of the bracket in the body are facilitated.
Compared with the prior art, the invention has the beneficial effects that:
(1) The invention realizes the accurate radiotherapy of radioactive particle yttrium-90 to tumors in close distance by adopting a radiotherapy mode in a cavity stent, and simultaneously combines other radioactive particles strontium-90 and iodine-125, and the beta rays are continuously emitted in a patient to interfere the DNA replication process in tumor cells, so that cancer cells are killed or the division growth of the cancer cells is inhibited.
(2) The stent has the function of dilating a narrow channel while being used for internal radiotherapy, and has good elasticity and memory property by designing the stent into a spring tube shape, adopting flexible glass or carbon fiber materials and arranging the memory alloy wires outside the medicine carrying cavity, so that the stent can be better suitable for various environments in the channels of a human body, realizes continuous and gentle dilation of the channels, and simultaneously reduces pain and discomfort of patients.
(3) The support is provided with the wavy patterns, so that the support can be well clamped at the affected part, displacement is prevented, and accurate radiotherapy of radioactive particles is ensured. Meanwhile, developing tantalum beads are further arranged in the support, so that the state of an affected part can be observed conveniently during implantation and after implantation.
(4) The support and the radioactive particles are integrated, the support and the radiotherapy medicament are installed at one time, the operation steps are simplified, the filling of the radiotherapy medicament is strictly controlled in a factory, and the pollution to the environment is reduced. Meanwhile, radioactive particles can be taken out while the bracket is taken out, so that innocent treatment is carried out on the radioactive particles, and the environmental protection requirement is met.
(5) The bracket can also be applied to accurate radiotherapy in bone cancer, and can be directly pulled out of the body through the tail fiber after the radiotherapy of the bone cancer is finished by arranging the tail fiber, so that secondary operation is not needed, and the pain of a patient is reduced.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to designate like parts throughout the figures. In the drawings:
FIG. 1 is a schematic view of a human body lumen stent according to an embodiment of the present invention;
FIG. 2 is an enlarged schematic view of a portion of a stent within a human body lumen according to an embodiment of the present invention;
fig. 3 is a schematic diagram of a stent applied to internal radiotherapy of bone cancer according to an embodiment of the present invention.
Wherein, 1-bracket main body, 2-medicine carrying cavity, 3-rubber plug, 4-wave pattern type bulge, 5-memory alloy wire and 6-tail wire.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
Example 1
The embodiment provides a radioactive human body cavity inner support which is placed in a human body cavity and comprises a spring tubular support main body 1, wherein the inside of the spring tube is hollow and is used as a medicine carrying cavity 2.
Wherein in the present embodiment, the drug-carrying chamber 2 is loaded with radioactive particles yttrium-90, strontium-90 and iodine-125 for internal radiotherapy, to kill or inhibit cancer cells by continuously emitting radiation in the patient. Wherein, the radioactive particle yttrium-90 and the iodine-125 are arranged at the middle part in the medicine carrying cavity 2, the radioactive particle strontium-90 is arranged at the left and right edges of the medicine carrying cavity 2, and the radioactive particle yttrium-90 accounts for 50-90% of the total mass. In addition, the radioactive particles yttrium-90, strontium-90 and iodine-125 are all powder or paste, and the particle size is 0.1-1mm. When the radioactive particles are distributed in a layered manner, the strontium-90 is arranged at the left edge and the right edge, and because the half-life period of the strontium is long and the radiation dose per unit time is small, the small-dose treatment can be carried out on the rest small quantity of tumor cells in the later period so as to prevent recurrence and reduce the damage to normal tissues. The yttrium-90 and the iodine-125 are arranged at the middle part, so that accurate radiotherapy can be better carried out on tumor cells, and the content of the iodine-125 can be properly increased for huge tumor tissues to improve the radiotherapy effect.
The inner diameter of the medicine carrying cavity of the bracket main body 1 is 0.1-1mm, the total length is 5-150mm, the bracket main body 1 of the invention can be applied to the cavities of the human body such as the prostate, liver/bile duct, esophagus, duodenum, trachea, colon, rectum cavity and the like, and the actual parameters can be selected according to the specific placed cavity so as to ensure that the bracket main body 1 and the part which can be clung to the tumor can carry out radiotherapy, and simultaneously the narrow part of the cavity can be expanded.
At present, although the prior art is also applied with the technology of using a stent and combining radioactive particles for treatment, the radioactive particles and the stent are separated from each other, and usually, a metal bare stent is firstly put in a body, then the radioactive particles are implanted in the stent, so that the tumor is treated by brachytherapy. Although the method has remarkable treatment effect, the operation has high complexity, the problem of radioactive particle falling exists, and when the treatment is finished, the stent can be taken out through the operation, but the radioactive particles cannot be taken out. Compared with the prior art, the support and the radioactive particles are integrated, the mounting of the support and the mounting of the radiotherapy medicament are completed at one time, the operation steps are simplified, the filling of the radiotherapy medicament is completed in a factory under strict control, and the environmental pollution caused by the falling of the radioactive particles in the operation is avoided. On the other hand, the stent and the radioactive particles can be taken out simultaneously, and the medicines in the stent are replaced and subjected to innocent treatment, so that the requirements of environmental protection are met.
The bracket main body 1 is in a spring tube shape made of plastic, carbon fiber or flexible glass. The flexible glass has the characteristics of extremely thin thickness and extremely strong bending resistance, and is made of a material of the bracket main body 1, so that the bracket main body is good in durability, extremely small in size, lower in trauma to tissues and greatly reduced in foreign body sensation after implantation; the carbon fiber material has the advantages of light weight, high strength, corrosion resistance and good stability, and can provide better expansion effect and patient comfort due to the excellent mechanical property and biocompatibility. The tubular spring structure is matched with the mechanical properties of carbon fiber or flexible glass, so that the bracket main body 1 has memory properties and elasticity capable of changing shape within a certain range, soft radial expansion force can be continuously generated in a human body cavity, certain deformation can be generated in the cavity with larger peristaltic property to conform to peristaltic motion, and discomfort of a human body is relieved.
In addition, the memory alloy wire 5 is also arranged on the outer wall of the medicine carrying cavity 2 of the bracket main body 1, the memory alloy wire 5 in the embodiment is made of titanium-nickel alloy, is in a softened state in an environment of 0-10 ℃ (or ice water), can be stretched into a straight line, is convenient for filling radioactive particles and putting into a body, and reduces damage to the cavity wall when putting into the body; in the environment of the human body (the environment temperature is more than 30 ℃), the rigidity can be gradually recovered, the memory alloy wire 5 is unfolded into a spring shape, and the memory alloy wire 5 also has a shape memory function and super elasticity, can be matched with the bracket main body 1 made of plastic, carbon fiber or flexible glass, and further improves the expansion function and the adaptation effect of the bracket main body 1 in a cavity.
In the prior art, the stent for in vivo expansion also has the problems of displacement, falling off and the like, so that the expansion effect is poor, in order to realize the stable expansion of the stent main body 1 at the affected part, and the accurate radiotherapy of the tumor by radioactive particles, the influence on other normal tissues is reduced, and the surface of the connecting part of the body cavity of a human body is continuously provided with the wavy bulge 4 while the stent main body 1 is in a spring tube shape. The diameter of the crest of the wavy line is 0.1-1mm wider than that of the crest of the wavy line, so that the limiting effect is realized, and the placement stability is improved.
Wherein, the opening parts at the upper and lower ends of the medicine carrying cavity 2 are provided with rubber plugs 3, the rubber plugs 3 are used for preventing radioactive particles from escaping, and substances in the human body cavity enter the medicine carrying cavity to influence the elasticity of the bracket main body 1.
Wherein, 2-8X-ray developing tantalum beads are distributed in the rubber plug 3 and the medicine carrying cavity 2, and can realize development under X-ray perspective, thereby helping to position and observe the placement condition of the bracket in the body.
Wherein, support main part 1 is integrated into one piece's structure, can transmit the atress well, effectively improves support main part 1 in the adaptability of internal to prevent the fracture damage, improve life.
Example 2
The specific implementation steps are the same as in example 1, except that the medicine carrying cavity 2 is loaded with radioactive particles yttrium-90, strontium-90 and iodine-125 for internal radiotherapy, wherein the radioactive particles are uniformly mixed according to strontium-90, yttrium-90 and iodine-125, and the radioactive particles yttrium-90, strontium-90 and iodine-125 are medicine carrying microspheres with the diameters of 10-100 mu m. Because the properties of the radioactive particles are different, after the radioactive particles are uniformly mixed, the effect of uniformly killing tumor tissues can be achieved, and the method is more suitable for tumor cell complexes with different differentiation degrees.
Example 3
The embodiment provides a radioactive human body intra-cavity stent which is applied to internal radiotherapy of bone cancer and comprises a stent main body 1 with a tubular structure, wherein a medicine carrying cavity 2 is formed between the outer wall surface of the stent main body 1 and a hollow inner cavity.
Wherein the medicine carrying cavity 2 is loaded with radioactive particles yttrium-90, strontium-90 and iodine-125 for internal radiotherapy, which are used for killing or inhibiting cancer cells by continuously emitting rays in a patient. The radioactive particles loaded in the medicine carrying cavity 2 are uniformly mixed, wherein the radioactive particles yttrium-90 accounts for 50% -90% of the total mass. The radioactive particles yttrium-90, strontium-90 and iodine-125 are drug-loaded microspheres, and the diameter of the drug-loaded microspheres is 10-100 mu m.
One end of the bracket main body 1 is connected with a tail fiber 6 for extraction, the tail fiber 6 is woven by X-ray development tantalum wires, development can be realized under X-ray perspective, and positioning and observation of the placement condition of the bracket in the body are facilitated.
The support of this embodiment can be applied in the bone cancer, and when specifically using, earlier punch near the tumour department of bone, place the support in the downthehole under the guide of X ray, realize the inside accurate radiotherapy of bone cancer. After the completion of the placement, the distal end of the fiber 6 portion is left outside the skin, waiting for the end of the radiotherapy. After the radiotherapy is finished, the bracket can be directly pulled out of the body through the tail fiber 6, so that the taking out through a secondary operation is avoided, and the pain of a patient is reduced.
Experimental example
The stents prepared in examples 1-3 were subjected to observation treatment experiments of a nude mouse-bearing human osteosarcoma transplantation model, and the experimental principles and specific experimental steps are as follows:
human osteogenic sarcoma cells (HOS-8603) are injected into the bone marrow cavity of the nude mouse, and a model of the bone of the nude mouse, namely human osteogenic sarcoma, is established. The nude mice after successful molding are randomly divided into 4 groups, 5 nude mice are sleeved with different spring brackets respectively for treatment, and the groups comprise a control group, an example 1 bracket group, an example 2 bracket group and an example 3 bracket group. After 4 weeks of treatment, the experiment was ended, nude mice were sacrificed at the end of the experiment to obtain tumor specimens, tumor weights were measured, the nude mice tumor specimens were sectioned, HE stained, and the microscopic cytological morphology of the tumor tissue was observed.
According to the statistical experimental results, the tumors of the experimental group sleeved with the stent are obviously smaller than those of the control group, and histological sections show that tumors of the treatment group adopting radioactive particles all show different degrees of promotion of apoptosis and necrosis of tumor cells. The differences between the example 1, example 2 and example 3 stent groups compared to the control group were statistically significant (P < 0.01).
Finally, it is to be understood that the above embodiments are merely exemplary embodiments employed for the purpose of illustrating the principles of the present invention, however, the present invention is not limited thereto. Various modifications and improvements may be made by those skilled in the art without departing from the principles and spirit of the invention, and such modifications and improvements are also considered within the scope of the invention.

Claims (10)

1. The radioactive intra-human-cavity stent is characterized by comprising a stent main body with a tubular structure, wherein a medicine carrying cavity is arranged in the stent main body, and radioactive yttrium-90 particles are loaded in the medicine carrying cavity.
2. The intra-luminal stent of claim 1 wherein the drug-loaded lumen is further loaded with radioactive particles strontium-90 and iodine-125, the radioactive particles being layered within the drug-loaded lumen;
wherein the radioactive particle strontium-90 is arranged at the left edge and the right edge of the medicine carrying cavity, and the radioactive particle yttrium-90 and the iodine-125 are arranged at the middle part of the medicine carrying cavity, wherein the radioactive particle yttrium-90 accounts for 50% -90% of the total mass.
3. The stent of claim 1, wherein the drug-loaded cavity is further loaded with radioactive particles strontium-90 and iodine-125, and the radioactive particles yttrium-90, strontium-90 and iodine-125 are uniformly mixed, wherein the radioactive particles yttrium-90 account for 50% -90% of the total mass.
4. A body endoluminal stent according to any one of claims 1 to 3 wherein the radioactive particles yttrium-90, strontium-90 and iodine-125 are one of powder, paste or drug-loaded microspheres, the particle size of the powder and paste being 0.1 to 1mm and the drug-loaded microspheres being 10 to 100 μm in diameter.
5. The human body intra-cavity support according to claim 4, wherein the support body is integrally formed in a spring tube shape, the total length is 5-150mm, and the support body is made of plastic, carbon fiber or flexible glass; the spring tube is hollow to realize the function of the medicine carrying cavity, and the inner diameter of the medicine carrying cavity is 0.1-1mm.
6. The human body intra-cavity support according to claim 5, wherein the openings at the upper end and the lower end of the medicine carrying cavity are provided with rubber plugs for sealing, and 2-8X-ray developing tantalum beads are distributed in the rubber plugs and the medicine carrying cavity.
7. The stent of claim 6, wherein the surface of the stent body contacting the human body lumen is continuously embossed, and the diameter of the wave crest is 0.1-1mm wider than the diameter of the non-embossed part.
8. The intra-luminal stent of claim 7 wherein the outer wall of the drug-carrying lumen is further provided with a memory alloy wire which expands in a spring-like fashion in an environment above 30 ℃.
9. The endoluminal stent according to claim 8, wherein the memory alloy wire is a titanium-nickel alloy.
10. The endoluminal stent of claim 4 wherein the stent body is adapted for internal radiation therapy of bone tumors and wherein one end of the stent body is connected to a fiber for withdrawal and wherein the fiber is woven from X-ray developed tantalum wire.
CN202311085314.1A 2023-08-28 2023-08-28 Human body cavity inner support with radioactivity Pending CN117064604A (en)

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