CN111330137A

CN111330137A - Drug delivery device

Info

Publication number: CN111330137A
Application number: CN201811543080.XA
Authority: CN
Inventors: 宋杰; 许�鹏; 官国锋; 杜晨晓; 廖土寿
Original assignee: Shenzhen Qingyuan Medical Instrument Co ltd
Current assignee: Shenzhen Qingyuan Medical Instrument Co ltd
Priority date: 2018-12-17
Filing date: 2018-12-17
Publication date: 2020-06-26

Abstract

The invention provides a drug delivery device, which comprises a drug injection balloon, a catheter and a balloon; the medicine injection bag comprises at least two different bag chambers; the catheter comprises a catheter wall and a diaphragm, wherein the diaphragm divides the interior of the catheter into different catheter cavities; one end of the catheter cavity is communicated with the sac chamber in a one-to-one mode; the balloon comprises a balloon wall, and the balloon wall encloses a dosing space; the catheter wall is provided with a first through hole and a second through hole corresponding to different catheter cavities, the first through hole is communicated with the drug administration space or the tissue space outside the balloon wall, and the second through hole is communicated with the drug administration space. The drug delivery device provided by the invention is kept under the skin of a human body after a tumor resection operation, can inject drugs into the drug injection sac from the outside of the skin or extract waste liquid from the drug injection sac, and guides the drugs to the balloon implanted in a tumor cavity through the catheter, so that the drugs can directly act on a part close to a lesion part; the respective supply of different liquid medicines and the taking out of the waste liquid in the body can be realized by using a single administration device.

Description

Drug delivery device

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a drug delivery device.

Background

In the face of tumors, the most effective medical approaches at present include surgery, radiation therapy and chemotherapy. Because the tissue boundary of the tumor is unclear, and the possibility that tumor cells break through the normal tissue boundary and metastasize and spread to a new part of the body exists, the success rate of eradicating the tumor by depending on the operation alone is low, and the combined treatment of radiation treatment and chemotherapy is often needed to reduce the recurrence rate. In most cases, the position of tumor recurrence is within 2cm around the primary focus, the recurrence tumor not only expands earlier, but also greatly improves the malignancy degree, and has great influence on the prognosis of patients; because the normal anatomical structure is changed due to the early operation, the states of peripheral tissues such as scalp, skull and the like are poor, and the patient has been subjected to radiotherapy for many times before the relapse, the secondary operation or the external radiotherapy is limited to a certain extent, so that the continuous treatment is difficult, and the relapse time is difficult to control; when the conventional chemotherapy treatment is carried out by intravenous injection of chemotherapeutic drugs, most drugs cannot penetrate through the blood brain barrier, the concentration of the chemotherapeutic drug liquid is greatly reduced when the chemotherapeutic drug liquid really reaches a tumor part, the curative effect is poor, and serious systemic toxic and side effects can occur when the drug dosage is increased.

Disclosure of Invention

The invention aims to provide a drug delivery device, and aims to solve the technical problems that a traditional tumor treatment scheme is difficult to continuously treat, the effective utilization rate of drugs is low, and the health is seriously damaged.

The invention is realized by the following steps that the medicine injection bag, the catheter and the balloon are included; the medicine injection bag comprises at least two different bag chambers; the catheter comprises a catheter wall and a diaphragm, wherein the diaphragm divides the interior of the catheter into different catheter cavities; one end of the catheter cavity is communicated with the sac chamber in a one-to-one mode; the balloon comprises a balloon wall, and the balloon wall encloses a dosing space; the catheter wall is provided with a first through hole and a second through hole corresponding to different catheter cavities, the second through hole is communicated with the drug administration space, and the first through hole is communicated with the drug administration space or the tissue space outside the balloon wall.

Further, the medicine injection bag comprises a base, a top cover and a supporting piece arranged between the base and the top cover, wherein the supporting piece comprises a bottom plate, a side plate connected with the bottom plate to form an accommodating cavity, and a partition plate arranged in the accommodating cavity, and the accommodating cavity is divided into at least two bag chambers by the partition plate; the top cover can be punctured by an atraumatic needle to inject medicine.

Furthermore, the top cover, the base, the catheter and the balloon are all made of biocompatible soft elastic materials, and the supporting piece is made of hard materials.

Furthermore, the inner wall of the bag chamber is coated with a radiation-proof coating, or is paved with a radiation-proof film, or the peripheral structure of the bag chamber is embedded with a radiation-proof inner core.

Furthermore, the medicine injection sac also comprises a medicine outlet pipe, the medicine outlet pipe comprises at least two medicine outlet pipe cavities, one end of each medicine outlet pipe cavity is connected with the sac chamber in a one-to-one mode, and the other end of each medicine outlet pipe cavity is connected with the catheter cavity in a one-to-one mode.

Furthermore, a check valve for preventing liquid in the drug delivery device from flowing back is arranged in the drug outlet cavity and/or the catheter cavity; alternatively, a two-way valve for controlling the flow direction of the liquid in the drug delivery device is arranged in the drug outlet cavity and/or the catheter cavity.

Furthermore, the number of the catheter cavities is two, the catheter cavities are divided into a first catheter cavity and a second catheter cavity, the first through hole is communicated with the first catheter cavity, the second through hole is communicated with the second catheter cavity, and the sac chambers are divided into a first sac chamber and a second sac chamber;

the first catheter cavity is communicated with the first sac chamber and is communicated with the tissue space through a first through hole; the second catheter cavity is communicated with the second sac chamber and is communicated with the drug administration space through a second through hole;

the first sac chamber and the first catheter cavity are used for sucking liquid in the tissue space and/or directly injecting chemotherapy liquid medicine into the tissue space; the second sac chamber and the second catheter cavity are used for injecting liquid medicine into the administration space.

Furthermore, the balloon wall is made of high polymer materials, micropores for communicating the tissue space and the administration space are arranged on the balloon wall, and the second balloon chamber and the second catheter cavity are used for injecting chemotherapy liquid medicine into the administration space; or the balloon wall is made of a liquid-impermeable material, and the second capsule chamber and the second catheter cavity are used for injecting the radiotherapy liquid medicine into the administration space.

Further, a balloon separation layer is arranged on the inner side of the balloon wall, and the balloon separation layer divides the administration space into a first administration space on the inner layer and a second administration space on the outer layer;

the number of the catheter cavities is two, the catheter cavities are divided into a second catheter cavity and a third catheter cavity, the first through hole is communicated with the first catheter cavity, the second through hole is communicated with the second catheter cavity, and the sac chambers are divided into a first sac chamber and a second sac chamber;

the first catheter cavity is communicated with the first sac chamber and is communicated with the first drug administration space through a first through hole; the second catheter cavity is communicated with the second sac chamber and is communicated with the second administration space through a second through hole;

the balloon separation layer is made of a liquid-impermeable material and is used for injecting radiotherapy liquid; the wall of the saccule is made of high molecular material and is used for injecting chemotherapy liquid medicine.

Furthermore, the catheter cavity is also provided with a third catheter cavity, the third catheter cavity is provided with a third through hole outside the balloon wall, and the balloon chamber is also provided with a third balloon chamber;

the third catheter cavity is communicated with the third sac chamber and is communicated with the tissue space through a third through hole;

the third sac chamber and the third catheter cavity are used for sucking liquid in the tissue space and/or directly injecting chemotherapy liquid medicine into the tissue space. .

The drug delivery device provided by the invention has the following beneficial technical effects:

the drug delivery device provided by the invention is completely kept under the skin of a human body after a tumor resection operation, so that the contact with external bacteria is blocked, and the infection probability is greatly reduced; can utilize the not damaged syringe needle to realize annotating the medicine or drawing out the medicine from annotating the medicine bag in to annotating the medicine bag from the skin to through pipe with medicine drainage to sacculus department, the sacculus part that is used for exporting the liquid medicine lies in the tumour chamber department that the patient left after excising the tumour, is close pathological change position, reduces substantially medicine use dose, avoids the repeated operation, reduces treatment cost, alleviates patient's misery.

The administration device provided by the invention is provided with at least two sac chambers and two catheter cavities, wherein the second through hole is communicated with the administration space, the first through hole is communicated with the administration space or the tissue space, the chemotherapy liquid medicine can be directly and quickly delivered to a diseased region, the long-term slow administration of the radiotherapy liquid medicine and the chemotherapy liquid medicine can also be respectively carried out, and when the first through hole is communicated with the tissue space outside the balloon wall, the administration device can also be used for extracting waste liquid medicine and pus effusion; can utilize single device of dosing to carry out multiple administration, the operation of changing dressings, can select the supply of liquid medicine, the change mode and select corresponding device of dosing according to the actual state of an illness, cooperate external equipment to treat the patient, reinforcing treatment.

Drawings

FIG. 1 is a schematic overall view of a drug delivery device provided by an embodiment of the present invention;

FIG. 2 is an exploded view of a drug-delivery pouch of a drug delivery device provided in accordance with an embodiment of the present invention;

FIG. 3 is a schematic view of a catheter of a drug delivery device provided in an embodiment of the present invention;

fig. 4 is a cross-sectional view of a balloon of a drug delivery device provided in accordance with embodiments one and two of the present invention;

fig. 5 is a cross-sectional view of a balloon of a drug delivery device provided in accordance with a third embodiment of the present invention;

fig. 6 is a cross-sectional view of a balloon of a drug delivery device provided in accordance with a fourth embodiment of the present invention.

Reference numerals referred to in the above figures are detailed below:

100-a medicine injection bag; 101-a sac chamber; 110-a top cover; 120-a base; 130-a support; 131-a bottom plate; 132-a side wall; 133-a divider plate; 134-medicine outlet pipe; 200-a catheter; 201-catheter lumen; 210-a conduit wall; 211-a through hole; 211 a-first via; 211 b-second via; 211 c-third via; 220-a membrane; 300-balloon; 301-a first dosing space; 302-a second dosing space; 310-balloon wall; 320-balloon separation layer.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly or indirectly secured to the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The terms "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positions based on the orientations or positions shown in the drawings, and are for convenience of description only and not to be construed as limiting the technical solution. The terms "first", "second" and "first" are used merely for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "plurality" is two or more unless specifically limited otherwise.

In order to explain the technical solution of the present invention, the following detailed description is made with reference to the specific drawings and examples.

Referring to fig. 1 and 3, the present invention is realized by a drug delivery device comprising a drug injection balloon 100, a catheter 200 and a balloon 300; the anther-injection sac 100 comprises at least two different sac chambers 101; the catheter 200 comprises a catheter wall 210 and a septum 220, the septum 220 separating the interior of the catheter 200 into distinct catheter lumens 201; one end of the catheter lumen 201 communicates with the balloon chamber 101 one-to-one; the balloon 300 comprises a balloon wall 310, the balloon wall 310 enclosing a dosing space; the catheter wall 210 is provided with a first through hole 211a and a second through hole 211b corresponding to different catheter lumens 201, the first through hole 211a is communicated with the administration space or the tissue space outside the balloon wall 310, and the second through hole 211b is communicated with the administration space.

The working principle of the drug delivery device is as follows:

the drug delivery device is fully implanted subcutaneously in a patient after tumor resection surgery. The drug injection sac 100 is implanted under the skin close to the skin of a patient, pressure can be applied to one sac chamber 101 of the drug injection sac 100 through pressing the drug injection sac extracutaneously, and the liquid medicine in the sac chamber 101 flows to a tissue space or a drug administration space through a catheter cavity 201 connected with the drug injection sac under the action of external pressure. The catheter lumen 201 of each catheter 200 communicates one-to-one with the balloon chamber 101 of the medication balloon 100 and with the tissue space or the administration space through the through hole 211. The balloon 300 is used as a device for directly outputting liquid medicine to a lesion part and implanted into a tumor cavity left after a tumor resection operation, so that the drug can be conveniently and directly administered to the lesion part, and the utilization efficiency of the drug is improved.

The working process of the drug delivery device comprises a drug injection process and a suction process:

in the drug injection process, the drug is injected into the capsule chamber 101 from the needle for external use, pressure is applied to the capsule chamber 101, the drug is injected into the drug administration space through the catheter cavity 201, the first through hole 211a and the second through hole 211b under the action of the pressure, or is injected into the tissue space through the first through hole 211a, specifically, the chemotherapy drug liquid gradually permeates into the tumor cavity near the balloon 300 after flowing into the drug administration space, and the slow drug administration effect is achieved; after flowing into the administration space, the radiotherapy liquid medicine can be stored in the administration space, and directly plays a role in radiotherapy on a diseased part; when the first through hole 211a is communicated with the tissue space, the catheter cavity 201 is connected with a capsule chamber 101 and the tissue space of the drug injection capsule 100, so that the drug liquid can be directly supplied to the lesion part, and the chemotherapy drug liquid in the capsule chamber 101 flows to the tissue space and directly acts on the lesion part under the action of external pressure.

The suction process is suitable for the situation that liquid medicine needs to be replaced or pus effusion needs to be extracted, when the liquid medicine in the subcutaneous implantable drug delivery device needs to be replaced, a nondestructive needle is used for puncturing the sac chamber 101 which is connected with the drug delivery space through the catheter cavity 201, and then waste liquid medicine can be extracted from the drug delivery space outside the skin and new liquid medicine can be injected; when first through-hole 211a intercommunication space of dosing, can aspirate internal liquid, when need directly follow the pus hydrops of taking out of tumour intracavity, abandonment liquid medicine, perhaps when need directly inject new chemotherapy liquid medicine in to the tissue space, use the not damaged needle to pierce the change, the replenishment of can realizing the change of taking out of pus hydrops or chemotherapy liquid medicine through catheter cavity 201 connection tissue space's capsule 101.

In the tumor treatment scheme, aiming at the condition that the effect of radiotherapy and chemotherapy after tumor operation is not ideal, a drug delivery device can be implanted in the position of a tumor cavity for matching with subsequent radiotherapy and chemotherapy after tumor tissues are removed by surgical operation. The subcutaneous administration device comprises a balloon 300 arranged in a tumor cavity, a drug injection balloon 100 which is implanted under the skin, can control the administration from the outside of the skin and can supply or replace drugs, and a catheter 200 for connecting the balloon 300 and the drug injection balloon 100. In the face of the need to replenish multiple drugs, conventional drug delivery devices can only rely on increasing the number of drug delivery devices, and the actual treatment process is often performed in combination with radiotherapy and chemotherapy, requiring multiple drugs to be delivered into the tumor cavity. A plurality of saccules 300 are arranged in a tumor cavity, so that the medicine is not uniformly released, the treatment effect is influenced, on the other hand, the increase of the number of the medicine feeding devices inevitably means that a plurality of catheters 200 exist, the operation difficulty is improved, and meanwhile, the pain of a patient is increased.

The subcutaneous implantable drug delivery device provided by the invention has the beneficial effects that:

the subcutaneous implantable drug delivery device provided by the invention is completely kept under the skin of a human body after a tumor resection operation, so that the contact with external bacteria is blocked, and the infection probability is greatly reduced; can utilize the not damaged syringe needle to realize injecting medicine into injection bag 100 or draw out the medicine from injection bag 100 from the skin outward to through pipe 200 with medicine drainage to sacculus 300 department, the sacculus 300 part that is used for exporting the liquid medicine is located the tumour chamber department that the patient left after excising the tumour, is close pathological change position, reduces substantially medicine use dose, avoids the repeated operation, reduces treatment cost, alleviates patient's misery.

The subcutaneous implantation type administration device provided by the invention is provided with at least two sac chambers 101 and two catheter cavities 201, wherein the second through hole 211b is communicated with an administration space, the first through hole 211a is communicated with the administration space or a tissue space, chemotherapy liquid medicine can be directly and quickly delivered to a lesion part, long-term slow administration of the radiotherapy liquid medicine and the chemotherapy liquid medicine can also be respectively carried out, and when the first through hole 211a is communicated with the tissue space outside the balloon wall, waste liquid medicine and pus effusion can also be extracted; can utilize single device of dosing to carry out multiple administration, the operation of changing dressings, can select the supply of liquid medicine, the change mode and select corresponding device of dosing according to the actual state of an illness, cooperate external equipment to treat the patient, reinforcing treatment.

Further, referring to fig. 2, the medicine injection bag 100 includes a base 120, a top cover 110 and a support 130 disposed between the base 120 and the top cover 110, the support 130 includes a bottom plate 131, a side plate connected to the bottom plate 131 to form a containing cavity, and a partition plate 134 disposed in the containing cavity, the partition plate 134 divides the containing cavity into at least two bag chambers 101; the cap 110 allows for atraumatic needle penetration for injection of the drug.

Specifically, the support 130 structure is arranged between the top cover 110 and the base 120, and the partition plate 134 is arranged on the support 130 structure, so that when the top cover 110 receives pressure, the side surface or the bottom surface of the capsule chamber 101 cannot deform under the action of the pressure, and the liquid medicine flows out from the medicine outlet tube 134 under the action of the pressure and flows to the space of the balloon 300 through the catheter 200, thereby avoiding that only the part of the medicine injection capsule 100 deforms and the liquid medicine does not flow into the catheter 200 under the action of the pressure. The support 130, on the other hand, also serves to prevent over-penetration of the atraumatic needle, avoiding the situation where the liquid drug is injected directly subcutaneously without being directed towards the lesion under the direction of the administration set.

Specifically, different bursas 101 can be set to have different shapes and/or heights, so that the different bursas 101 can be distinguished by using a visual method from the outside of the skin or by using CT imaging; different concentrations of non-X-ray transparent materials can be added into the supporting members 130 or the base 120 and the cover handles corresponding to different capsules 101, so that different capsules 101 can be distinguished by means of X-ray irradiation.

Specifically, the cap 110 may be punctured several times with a atraumatic needle without leakage, so that the atraumatic needle may be used to supplement the liquid medicine from the outside of the skin into the capsule 100 several times, or to suck out the waste liquid medicine and the pus effusion from the capsule 100 several times.

Alternatively, the supporting member 130 may be embedded in the base 120; alternatively, the top cover 110 and the base 120 are integrally formed, a groove for inserting the supporting member 130 is formed on the outer side of the drug-injecting bag 100, and the supporting member 130 is embedded in the integrally formed member of the top cover 110 and the base 120, because the supporting member 130 directly contacts with the biological tissue at this time, the supporting member 130 should preferably be made of a biocompatible hard material; alternatively, the capsule 100 includes a top cover 110 and a support 130, the support 130 includes a bottom plate 131 and a side wall 132, the side of the top cover 110 is tightly attached to the side wall 132, the soft top cover 110 is sleeved on the side wall 132 of the support 130 to form a seal, so as to enclose the inner space of the capsule 100, and the partition 134 is connected with the bottom plate 131, the side wall 132 and the top surface.

It should be understood that the above is only a preferred embodiment of the present invention, and whether the base 120 is present or not, or the position relationship between the supporting member 130 and the top cover 110 and the base 120, is only required to satisfy the requirement of being able to form two or more pockets 101, and does not set any limit to the scope of the present invention.

Optionally, the catheter 200 and balloon 300 are integrally formed.

Further, the top cover 110, the base 120, the catheter 200 and the balloon 300 are made of a biocompatible soft elastic material, and the supporting member 130 is made of a hard material.

Specifically, the catheter 200 and the balloon 300 may be made of silicone, latex, polyurethane, nylon, or nylon elastomer. The material has excellent biocompatibility, does not produce undesirable biological reaction or undesirable material physical and chemical reaction, can grow biological tissues around the material without rejection reaction, and is favorable for healing of surgical wounds. Meanwhile, the material is soft, so that the wiring of the catheter 200 is facilitated on one hand, and the balloon 300 is conveniently expanded properly under the internal pressure after the liquid medicine is injected on the other hand, so that the balloon 300 is more attached to the cavity wall of the tumor cavity, and the action position of the liquid medicine for radiotherapy can be closer to the pathological tissue; or the micropores of the balloon wall 310 of the balloon 300 can be expanded along with the expansion of the balloon 300, so that the chemotherapy liquid medicine in the balloon 300 can be more efficiently and directly diffused to the lesion part under the pressure, the efficiency of the liquid medicine acting on the lesion part when the top cover 110 of the drug injection balloon 100 is under the pressure or the chemotherapy liquid medicine is injected into the drug injection balloon 100 is improved, the curative effect is improved, and the treatment cost is reduced.

Further, the inner wall of the capsule chamber 101 is coated with a radiation-proof coating, or is paved with a radiation-proof film, or a radiation-proof inner core is embedded in the peripheral structure of the capsule chamber 101.

Specifically, the radiation-proof material is lead, that is, the inner wall of the capsule chamber 101 is coated with a lead coating, or a lead film is laid, or a lead inner core is embedded in the peripheral structure of the capsule chamber 101. The radiotherapy liquid medicine inevitably contains radioactive elements, and the radiation damage of the radioactive elements to healthy cell tissues can be avoided by adopting a lead coating, a lead film or a lead inner core.

Further, the medicine injection sac 100 further comprises a medicine outlet tube 134, the medicine outlet tube 134 comprises at least two medicine outlet tube cavities, one end of each medicine outlet tube cavity is connected with the sac chamber 101 in a one-to-one mode, and the other end of each medicine outlet tube cavity is connected with the catheter cavity 201 in a one-to-one mode.

Preferably, the divider 134, the outlet tube 134 and the support 130 are integrally formed.

Specifically, referring to the figures, the cross-sectional shape of the catheter 200 and the cross-sectional shape of the distal end of the drug discharge tube 134 are matched, the catheter 200 may be a double lumen catheter 200, the cross-sectional shape of the catheter 200 is double "D" shape, and correspondingly, the cross-sectional shape of the lumen 201 of the catheter and the cross-sectional shape of the distal end of the drug discharge tube 134 for insertion into the catheter 200 are both "D" shape. It should be understood that the cross-sectional shape of the conduit 200 need only be convenient for connection, and the above-described embodiments should not be taken as limiting the scope of the invention.

Further, a check valve for preventing liquid in the drug delivery device from flowing back is arranged in the drug outlet cavity and/or the catheter cavity 201; alternatively, a two-way valve for controlling the flow of fluid within the administration set is provided within the outlet lumen and/or catheter lumen 201.

In particular, the valve-like structure may be provided inside the catheter 200, similar to the structure of a heart valve or a venous valve, which is simple and effective in structure, is integrally formed with the catheter 200, and is adapted to be provided in a flexible material to prevent backflow of fluid.

In one embodiment, referring to fig. 4, the number of the catheter lumens 201 is two, and the catheter lumens are divided into a first catheter lumen and a second catheter lumen, the first through hole 211a communicates with the first catheter lumen, the second through hole 211b communicates with the second catheter lumen, and the sac chamber 101 is divided into a first sac chamber and a second sac chamber; the first catheter lumen is in communication with the first balloon chamber and is in communication with the tissue space through a first through hole 211 a; the second catheter lumen is communicated with the second balloon chamber and is communicated with the administration space through a second through hole 211 b; the first sac chamber and the first catheter cavity are used for sucking liquid in the tissue space and/or directly injecting chemotherapy liquid medicine into the tissue space; the second sac chamber and the second catheter cavity are used for injecting liquid medicine into the administration space.

Further, the balloon wall 310 is made of a high polymer material, micropores for communicating the tissue space and the administration space are formed in the balloon wall 310, and the second sac chamber and the second catheter cavity are used for injecting chemotherapy liquid medicine into the administration space; alternatively, the balloon wall 310 is made of a liquid impermeable material, and the second balloon chamber and the second catheter lumen are used for injecting the radiotherapy liquid into the administration space.

Specifically, the polymer material is a flexible polymer material, and can be latex, nylon or polyurethane. The flexible polymer material with the micropores can be properly expanded after being injected with the liquid medicine in the balloon 300 to be more suitable for the shape of a tumor cavity, so that the chemotherapy liquid medicine in the balloon can be conveniently and directly diffused to the lesion tissue to kill the residual lesion cells; meanwhile, after the saccule 300 is inflated by the injected liquid medicine, the micropores are expanded, which is more beneficial to the outflow of the chemotherapy liquid medicine and generates curative effect.

In another embodiment, referring to fig. 5, a balloon separation layer 320 is disposed inside the balloon wall 310, and the balloon separation layer 320 divides the administration space into an inner first administration space 301 and an outer second administration space 302; the number of the catheter lumens 201 is two, the catheter lumens are divided into a first catheter lumen and a second catheter lumen, the first through hole 211a is communicated with the first catheter lumen, the second through hole 211b is communicated with the second catheter lumen, and the balloon chamber 101 is divided into a first balloon chamber and a second balloon chamber; the first catheter lumen is communicated with the first balloon chamber and communicated with the first administration space 301 through the first through hole 211 a; the second catheter lumen is communicated with the second balloon chamber and communicated with the second administration space 302 through the second through hole 211 b; the balloon spacer 320 is made of a liquid impermeable material for injecting a radiotherapy solution; the balloon wall 310 is made of a polymer material and is used for injecting chemotherapy drug solution.

Specifically, sacculus separate layer 320 is divided into first space 301 and the second space 302 of dosing with sacculus 300, sacculus separate layer 320 is made by the material that the flexibility is good but no liquid permeability, the first radiotherapy liquid medicine of dosing space 301 can not permeate through sacculus separate layer 320 and spread to the second space 302 of dosing, first space 301 of dosing can the dilatate under the effect of pressure, make the radiotherapy liquid medicine can carry out the radiotherapy in the position that more is close pathological change tissue, be favorable to improving the availability factor of radiotherapy liquid medicine, reduce treatment cost when improving the curative effect.

In another embodiment, referring to fig. 6, the catheter lumen 201 is further provided with a third catheter lumen, the third catheter lumen is provided with a third through hole 211c outside the balloon wall, and the balloon chamber 101 is further provided with a third balloon chamber; the third catheter lumen is in communication with the third sac chamber and is in communication with the tissue space through a third through hole 211 c; the third sac chamber and the third catheter cavity are used for sucking liquid in the tissue space and/or directly injecting chemotherapy liquid medicine into the tissue space.

The following is detailed by means of four specific examples:

example one

Referring to fig. 4, in the present embodiment, the number of the catheter lumens 201 is two, the two catheter lumens are divided into a first catheter lumen and a second catheter lumen, the first through hole 211a is communicated with the first catheter lumen, the second through hole 211b is communicated with the second catheter lumen, the balloon chamber 101 is divided into a first balloon chamber and a second balloon chamber, and the balloon wall 310 is made of a liquid-impermeable material;

the first catheter lumen is in communication with the first balloon chamber and is in communication with the tissue space through a first through hole 211 a; the second catheter lumen is communicated with the second balloon chamber and is communicated with the administration space through a second through hole 211 b;

the first sac chamber and the first catheter cavity are used for sucking liquid in the tissue space and can also be used for directly injecting chemotherapy liquid medicine into the tissue space; the balloon wall 310 is made of a liquid impermeable material, and the second balloon chamber and the second catheter lumen are used for injecting a radiotherapy liquid into the administration space.

Specifically, when chemotherapy liquid medicine needs to be injected into the tissue space, the first sac chamber can be injected with the chemotherapy liquid medicine by the atraumatic needle, then the first sac chamber is pressed from the outside of the skin, the chemotherapy liquid medicine flows along the first catheter cavity under the action of pressure, finally flows into the tissue space through the first through hole 211a and directly acts on the lesion part;

when the radiotherapy liquid medicine needs to be injected into the administration space, the non-invasive needle head can be used for injecting the radiotherapy liquid medicine into the second sac chamber, then the second sac chamber is pressed from the outside of the skin, the radiotherapy liquid medicine flows along the second catheter cavity under the action of pressure and finally flows into the administration space through the second through hole 211b, and the balloon wall 310 is properly expanded and expanded to adapt to the size and the shape of the tumor cavity under the action of internal pressure, so that the radiotherapy liquid medicine can be used for radiotherapy treatment at the position close to a lesion part;

when the waste chemotherapy liquid medicine or the pus effusion needs to be extracted from the tissue space, the nondestructive needle can be used for puncturing the first sac chamber from the outside of the skin for suction, namely the waste chemotherapy liquid medicine can be extracted from the tissue space under the action of the internal pressure of the human body, or the pus effusion passes through the first through hole 211a, the first catheter cavity and the first sac chamber;

when needs are followed the space of dosing and are taken out abandonment radiotherapy liquid medicine, can pierce the suction of second bag room from the skin with not damaged needle, can be under the effect of human internal pressure, take out abandonment radiotherapy liquid medicine from the space of dosing through second through-hole 211b, second pipe chamber and second bag room.

Example two

Referring to fig. 4, in the present embodiment, the number of the catheter lumens 201 is two, the catheter lumens are divided into a first catheter lumen and a second catheter lumen, the first through hole 211a is communicated with the first catheter lumen, the second through hole 211b is communicated with the second catheter lumen, the balloon chamber 101 is divided into a first balloon chamber and a second balloon chamber, the balloon wall 310 is made of a polymer material, and the balloon wall 310 is provided with micropores communicating a tissue space and a drug administration space;

the first sac chamber and the first catheter cavity are used for sucking liquid in the tissue space and can also be used for directly injecting chemotherapy liquid medicine into the tissue space, and the second sac chamber and the second catheter cavity are used for injecting chemotherapy liquid medicine into the administration space.

Specifically, when chemotherapy liquid medicine needs to be directly injected into the tissue space, the first sac chamber can be injected with the chemotherapy liquid medicine by the atraumatic needle, then the first sac chamber is pressed from the outside of the skin, the chemotherapy liquid medicine flows along the first catheter cavity under the action of pressure, finally flows into the tissue space through the first through hole 211a and directly acts on the lesion part;

when the chemotherapy liquid medicine needs to be injected into the administration space, the second sac chamber can be injected with the chemotherapy liquid medicine by the atraumatic needle, then the second sac chamber is pressed from the outside of the skin, and the chemotherapy liquid medicine flows along the second catheter cavity under the action of pressure and finally flows into the administration space through the second through hole 211 b; the balloon wall 310 is expanded properly under the action of internal pressure to adapt to the size and shape of the tumor cavity, and the chemotherapy liquid medicine is slowly released at the position close to the lesion;

when the waste chemotherapy liquid medicine or the pus effusion is required to be extracted from the direct tissue space, the nondestructive needle can be used for puncturing the first sac chamber from the outside of the skin for suction, and the waste chemotherapy liquid medicine or the pus effusion can be extracted from the tissue space through the first through hole 211a, the first catheter cavity and the first sac chamber under the action of the internal pressure of the human body;

when the waste chemotherapy liquid medicine needs to be drawn out from the administration space, the non-invasive needle can be used for penetrating into the second bag chamber from the outside of the skin for suction, and the waste chemotherapy liquid medicine can be drawn out from the administration space through the second through hole 211b, the second catheter cavity and the second bag chamber under the action of the internal pressure of a human body.

EXAMPLE III

Referring to fig. 5, in the present embodiment, a balloon separation layer 320 is disposed inside the balloon wall 310, and the balloon separation layer 320 divides the administration space into an inner first administration space 301 and an outer second administration space 302;

the number of the catheter lumens 201 is two, the catheter lumens are divided into a first catheter lumen and a second catheter lumen, the first through hole 211a is communicated with the first catheter lumen, the second through hole 211b is communicated with the second catheter lumen, and the balloon chamber 101 is divided into a first balloon chamber and a second balloon chamber;

the first catheter lumen is communicated with the first balloon chamber and communicated with the first administration space 301 through the first through hole 211 a; the second catheter lumen is communicated with the second balloon chamber and communicated with the second administration space 302 through the second through hole 211 b;

the balloon separation layer 320 is made of a liquid-impermeable material, and the first balloon chamber and the first catheter cavity are used for injecting radiotherapy liquid medicine into the first administration space 301; the balloon wall 310 is made of high polymer material, the balloon wall 310 is provided with micropores communicating the tissue space and the administration space, and the second sac chamber and the second catheter cavity are used for injecting chemotherapy liquid medicine into the second administration space 302.

Specifically, when the radiotherapy liquid medicine needs to be injected into the first administration space 301, the non-invasive needle can be used for injecting the radiotherapy liquid medicine into the first sac chamber, then the first sac chamber is pressed from the outside of the skin, the radiotherapy liquid medicine flows along the first catheter cavity under the action of pressure and finally flows into the first administration space 301 through the first through hole 211a, and the balloon separation layer 320 is appropriately expanded under the action of internal pressure to adapt to the size and the shape of the tumor cavity, so that the radiotherapy liquid medicine can be used for radiotherapy treatment at a position close to a lesion part;

when chemotherapy liquid medicine needs to be injected into the second administration space 302, the second capsule chamber can be injected with the chemotherapy liquid medicine by using a non-invasive needle, then the second capsule chamber is pressed from the outside of the skin, the chemotherapy liquid medicine flows along the second catheter cavity under the action of pressure and finally flows into the administration space through the second through hole 211b, the balloon wall 310 is properly expanded and expanded to adapt to the size and the shape of the tumor cavity under the action of internal pressure, and the chemotherapy liquid medicine is slowly released at a position close to a lesion part;

when the waste radiotherapy liquid medicine needs to be extracted from the first administration space 301, a non-invasive needle can be used for puncturing the first sac chamber from the outside of the skin for suction, namely, the waste radiotherapy liquid medicine can be extracted from the tissue space through the first through hole 211a, the first catheter cavity and the first sac chamber under the action of the internal pressure of a human body;

when the waste chemotherapy liquid medicine needs to be extracted from the second administration space 302, the atraumatic needle can be used for penetrating into the second capsule chamber from the outside of the skin for suction, and the waste chemotherapy liquid medicine can be extracted from the administration space through the second through hole 211b, the second catheter cavity and the second capsule chamber under the action of the internal pressure of a human body.

Example four

Referring to fig. 6, in the present embodiment, a balloon separation layer 320 is disposed inside the balloon wall 310, and the balloon separation layer 320 divides the administration space into an inner first administration space 301 and an outer second administration space 302;

the catheter lumen 201 includes a first catheter lumen, a second catheter lumen, and a third catheter lumen, the through-hole 211 includes a first through-hole 211a, a second through-hole 211b, and a third through-hole 211c, and the balloon chamber 101 includes a first balloon chamber, a second balloon chamber, and a third balloon chamber;

the first catheter lumen is communicated with the first balloon chamber and communicated with the first administration space 301 through the first through hole 211 a; the second catheter lumen is communicated with the second balloon chamber and communicated with the second administration space 302 through the second through hole 211 b; the third catheter lumen is in communication with the third sac chamber and is in communication with the tissue space through a third through hole 211 c;

the balloon separation layer 320 is made of a liquid-impermeable material, and the first balloon chamber and the first catheter cavity are used for injecting radiotherapy liquid medicine into the first administration space 301; the balloon wall 310 is made of high polymer materials, micropores for communicating the tissue space and the administration space are formed in the balloon wall 310, and the second sac chamber and the second catheter cavity are used for injecting chemotherapy liquid medicine into the second administration space 302; the third sac chamber and the third catheter cavity are used for sucking liquid in the tissue space and can also be used for directly injecting chemotherapy liquid medicine into the tissue space.

when chemotherapy liquid medicine needs to be injected into the tissue space, the third sac chamber can be injected with the chemotherapy liquid medicine by the non-invasive needle, then the third sac chamber is pressed from the outside of the skin, the chemotherapy liquid medicine flows along the third catheter cavity under the action of pressure, and finally flows into the tissue space through the third through hole 211c to directly act on a diseased region;

when the waste chemotherapy liquid medicine needs to be extracted from the second administration space 302, a non-invasive needle can be used for puncturing the second sac chamber from the outside of the skin for suction, namely, the waste chemotherapy liquid medicine can be extracted from the administration space through the second through hole 211b, the second catheter cavity and the second sac chamber under the action of the internal pressure of a human body;

when needs are followed tissue space and are taken out abandonment chemotherapy liquid medicine or pus hydrops, can pierce the suction of third bag room from the skin with the not damaged needle, can be under the effect of human internal pressure, take out abandonment chemotherapy liquid medicine or pus hydrops from tissue space through third through-hole 211c, third pipe chamber and third bag room.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims

1. A drug delivery device comprising a drug-injection balloon, a catheter and a balloon;

the drug injection capsule comprises at least two different capsule chambers;

the catheter comprises a catheter wall and a septum that separates the interior of the catheter into different catheter lumens; one end of the catheter cavity is in one-to-one communication with the sac chamber;

the balloon comprises a balloon wall, and the balloon wall encloses a drug administration space;

the catheter wall is provided with a first through hole and a second through hole corresponding to different catheter cavities, the second through hole is communicated with the drug administration space, and the first through hole is communicated with the drug administration space or a tissue space outside the balloon wall.

2. The drug delivery device according to claim 1, wherein the drug-injecting bag comprises a base, a top cover and a support member arranged between the base and the top cover, the support member comprises a bottom plate, a side plate connected with the bottom plate to form a containing cavity, and a partition plate arranged in the containing cavity, and the partition plate divides the containing cavity into at least two bag chambers; the cap may be used for atraumatic needle penetration for drug infusion.

3. The drug delivery device of claim 2, wherein the cap, base, catheter and balloon are all made of a biocompatible soft elastomeric material, and the support is made of a hard material.

4. The drug delivery device of claim 1, wherein the inner wall of the capsule is coated with a radiation protective coating, or is coated with a radiation protective film, or has a radiation protective core embedded in the peripheral structure of the capsule.

5. The drug delivery device of claim 1, wherein the drug-filled sac further comprises a drug outlet tube, the drug outlet tube comprising at least two drug outlet lumens, one end of the drug outlet lumens being connected one-to-one with the sac chamber and the other end being connected one-to-one with the catheter lumen.

6. The drug delivery device of claim 5, wherein a non-return valve is disposed in the drug outlet lumen and/or the catheter lumen for preventing backflow of fluid within the drug delivery device; alternatively, a two-way valve for controlling the flow direction of liquid in the drug delivery device is arranged in the drug outlet cavity and/or the catheter cavity.

7. The delivery device of any of claims 1 to 6, wherein:

the number of the catheter cavities is two, the catheter cavities are divided into a first catheter cavity and a second catheter cavity, the first through hole is communicated with the first catheter cavity, the second through hole is communicated with the second catheter cavity, and the sac chambers are divided into a first sac chamber and a second sac chamber;

the first catheter lumen is communicated with the first balloon chamber and communicated with the tissue space through the first through hole; the second catheter cavity is communicated with the second sac chamber and is communicated with the administration space through the second through hole;

8. The drug delivery device according to claim 7, wherein the balloon wall is made of a polymer material, the balloon wall is provided with micropores for communicating the tissue space and the drug delivery space, and the second balloon chamber and the second catheter lumen are used for injecting chemotherapy drug solution into the drug delivery space; or the balloon wall is made of a liquid-impermeable material, and the second balloon chamber and the second catheter cavity are used for injecting radiotherapy liquid medicine into the administration space.

9. The drug delivery device according to any one of claims 1 to 6, characterized in that a balloon separation layer is provided inside the balloon wall, which divides the drug delivery space into a first drug delivery space on the inner layer and a second drug delivery space on the outer layer;

the first catheter cavity is communicated with the first sac chamber and is communicated with the first administration space through the first through hole; the second catheter cavity is communicated with the second sac chamber and is communicated with the second administration space through the second through hole;

the balloon separation layer is made of a liquid-impermeable material and is used for injecting a radiotherapy liquid; the sacculus wall is made of high polymer materials and is used for injecting chemotherapy liquid medicine.

10. The drug delivery device of claim 9, wherein the catheter lumen is further defined by a third catheter lumen having a third through-hole external to the balloon wall, the balloon further being defined by a third balloon;

the third catheter lumen is communicated with the third sac chamber and communicated with the tissue space through the third through hole;

the third sac chamber and the third catheter cavity are used for sucking liquid in the tissue space and/or directly injecting chemotherapy liquid medicine into the tissue space.