CN217793261U - Continuous drug administration device in superficial solid tumor - Google Patents

Abstract

The utility model relates to a continuous drug administration device in superficial solid tumor, which comprises a puncture needle, a drug administration catheter, a first injection port and a second injection port, wherein one end of the drug administration catheter is connected with the puncture needle which is used for guiding the drug administration catheter to enter the subcutaneous part from a first puncture point of the skin and penetrate through the tumor and then penetrate out from a second puncture point of the skin; the wall of the middle section of the administration catheter is provided with a plurality of through holes for communicating the inner cavity of the administration catheter with the outside, and the through holes are used for outflow of liquid medicine; the first injection port and the second injection port are respectively embedded under the skin of the first puncture point and the second puncture point; after the drug delivery catheter with the through hole guided by the puncture needle is positioned in the tumor, the puncture needle is cut off, and two ends of the drug delivery catheter are respectively communicated with the first injection port and the second injection port through the connectors. The device of dosing have extensive applicability, simple easy operation, be convenient for persist for a long time and repeatedly dose, do not arouse the tumour risk of disseminating, do not influence the advantage of normal life.

Description

Continuous drug administration device in superficial solid tumor

Technical Field

The utility model belongs to the technical field of medical instrument, concretely relates to last device of dosing in shallow solid tumor tumour.

Background

Overcoming cancer is a worldwide problem. In recent years, with the advent of novel therapies such as targeted therapy and immunotherapy and the combined use of conventional therapies such as chemotherapy and radiotherapy, the survival rate of cancer patients has been greatly improved, and more patients have reached long-term survival in the tumor-free or tumor-bearing state. Nevertheless, there is still much room for improvement in the treatment of malignant tumors. Emerging immunotherapy has significant efficacy in hematological tumors, even reaching a complete remission rate of 90%, but still has minimal efficacy in solid tumor applications. For this reason, a physiological barrier is often present between the organ where the solid tumor tissue is located and the internal environment of the human body, and it is difficult to exert a direct antitumor effect by a blood circulation administration mode.

The local injection administration in tumor is a special tumor treatment method, and directly injects the medicine into the tumor to ensure that the local medicine dose is concentrated and the toxic and side effects of the medicine on the whole body are reduced. Compared with systemic treatment, local injection administration in tumors is a potential treatment method with strong pertinence, reliable curative effect and low side effect. At present, the common research of local intratumoral injection administration mainly focuses on liver cancer, such as liver cancer interventional therapy, percutaneous intratumoral administration by liver puncture, intratumoral absolute ethyl alcohol injection under ultrasonic guidance and the like.

Superficial solid tumors are common in the human body and are derived from soft tissues, such as soft tissue sarcoma. Soft tissue sarcoma is a malignant tumor derived from mesoderm, and occurs in many limbs, often in the superficial parts of the body. Studies have shown that most soft tissue sarcomas are not susceptible to conventional treatments such as chemotherapy. Although emerging therapies such as targeted therapy and immunotherapy bring certain breakthroughs to the treatment of soft tissue sarcoma, patients often face the problems of drug resistance, tumor ultra-progression and the like, and bear the risks of serious adverse reactions of systemic multiple systems. On the other hand, soft tissue sarcoma progresses rapidly, so that the lesion is often unresectable or difficult to be removed when a patient is in a doctor, and distant metastasis of organs such as lung is easily caused by high tumor load. Therefore, the search for more effective soft tissue tumor treatment methods has important significance for controlling diseases, creating operation opportunities and improving the survival rate of patients. As previously mentioned, local intratumoral injection is also a promising treatment for soft tissue sarcoma. However, its clinical application and research is rare, mainly limited by the following pending problems: (1) The lack of an effective and reliable local drug delivery device within soft tissue tumor tumors; (2) The vascular intervention method has great application difficulty in soft tissue tumor: soft tissue tumors often have difficulty finding a clear blood supply vessel for administration; (3) The tumor treatment needs long-term and multiple drug administration, and repeated puncture increases the burden and pain of patients; (4) Repeated puncture may cause the tumor to spread in soft tissues, and meanwhile, the risk of infection of the puncture part and the like is increased; (5) The dose of single puncture injection in solid tumors is limited, and the effective drug concentration for causing the tumor to shrink is difficult to achieve and maintain.

In summary, there is currently a lack of reliable methods for intratumoral administration of soft tissue tumors, and an ideal system for intratumoral injection of soft tissue tumors should meet the following requirements: (1) the operation is simple, the damage is small, and the implementation is easy; (2) does not increase the risk of tumor dissemination; (3) The drug can be continuously applied to the tumor regression, and the transformation treatment of the unresectable and difficult-to-excise tumor is realized; and (4) the pain of the patient caused by repeated puncture is avoided.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a device that is applicable to continuously dosing in shallow solid tumor to it provides more excellent clinical selection to expect for soft tissue tumor local treatment.

In order to achieve the above object, the utility model provides a following technical scheme:

a continuous drug delivery device in superficial solid tumor comprises a puncture needle, a drug delivery catheter, a first injection port and a second injection port, wherein one end of the drug delivery catheter is connected with the puncture needle, and the puncture needle is used for guiding the drug delivery catheter to enter the subcutaneous part from a first puncture point of the skin, penetrate through the tumor and then penetrate out from a second puncture point of the skin; the wall of the middle section of the administration catheter is provided with a plurality of through holes for communicating the inner cavity of the administration catheter with the outside, and the through holes are used for outflow of liquid medicine; the first injection port and the second injection port are respectively embedded under the skin of the first puncture point and the second puncture point; after the drug delivery catheter with the through hole guided by the puncture needle is positioned in the tumor, the puncture needle is cut off, and two ends of the drug delivery catheter are respectively communicated with the first injection port and the second injection port through the connectors.

Furthermore, 4-6 puncture needles with different types and sizes are arranged and are respectively suitable for tumor puncture with different subcutaneous depths and different volumes, the puncture needle is an arc-shaped right-angle needle, and the cross section of the needle point of the puncture needle is in a regular triangle shape.

Furthermore, according to the length of the drug delivery catheter with the through hole and the requirement of being equal to the diameter of the tumor, 4-6 types of drug delivery catheters can be preset to meet the drug delivery requirements of different tumor sizes.

Furthermore, through the design of the through hole on the administration catheter, the drug can be permeated into the tumor tissue and can be transferred to the tumor tissue through the diffusion effect in the tissue. The through holes are uniformly distributed on the pipe wall of the middle section of the administration catheter, and the aperture of the through holes is 100 +/-10 mu m.

Furthermore, the material of the administration catheter is medical polyvinyl chloride.

Further, first injection port, second injection port are identical, all include the port seat, and the port seat is inside to be equipped with the reservoir, and port seat outside bottom one side is equipped with the export with the reservoir intercommunication, and bottom one side of reservoir is connected with the connector after outwards extending to the port seat outside by the export, and the top of reservoir exposes in injection port top surface, keeps away from the nearly bottom in export one side outside the port seat and still is provided with the fixed orifices.

Further, the harbor seat is in a shape similar to a circular truncated cone.

Furthermore, the material of the liquid storage bag is polyurethane.

Furthermore, the shape of the connector is pagoda-shaped.

The utility model has the advantages that:

1. the applicability is wide: suitable for intratumoral injection administration of superficial solid tumors of a human body, the medicament can comprise: chemotherapeutic drugs, absolute ethanol, immunological agents, etc.; the tumor category is not limited, and is suitable for all types of solid tumors, and can particularly promote surgical transformation treatment of unresectable or difficult-to-resect tumors.

2. The technology is simple, and the operation is rapid: the implementation process only needs puncture and a subcutaneous embedding injection port, the operation is simple, and no special equipment is needed.

3. Can be kept for a long time and repeatedly administrated: the drug delivery device including the drug delivery catheter and the injection port can be kept in the body for a long time, and can be repeatedly and continuously delivered during the treatment period, so that the greater drug concentration in the tumor is maintained, the treatment effect is improved, and the injury caused by multiple times of puncture is avoided.

4. Does not cause risk of tumor dissemination: the drug delivery device has small volume, is embedded in a solid tumor area, can be removed in the process of surgical operation, and does not increase the risk of tumor dissemination.

5. The drug delivery device is left under the skin and does not affect the normal life of the patient.

Drawings

FIG. 1 is a schematic view of the structure of the drug delivery device of the present invention;

FIG. 2 is a schematic view of a drug delivery catheter pre-attached with a piercing needle;

FIG. 3 is a partially enlarged schematic view of a drug delivery catheter;

FIG. 4 is a schematic view of the port of injection;

FIG. 5 is a partially enlarged view of the connection head;

FIG. 6 is a schematic view of the injection procedure using an atraumatic needle into the port of injection;

in the figure: 1-port of first injection; 2-second port of injection; 3-a drug delivery catheter; 4, puncturing needle; 5-a connector; 6-fixing holes; 7-a liquid storage bag; 8-harbor seat; 9-a through hole; 10-skin; 11-tumor.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be described in detail below. It is to be understood that the embodiments described are only some embodiments of the invention, and not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art on the premise of creative work belong to the protection scope of the present invention.

In the description of the present invention, it is to be understood that the terms "upper", "lower", "inner", "outer", "intermediate", "length", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the equipment or components referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

As shown in fig. 1-5: a continuous drug delivery device in superficial solid tumor comprises a puncture needle 4, a drug delivery catheter 3, a first injection port 1 and a second injection port 2, wherein one end of the drug delivery catheter 3 is connected with the puncture needle 4, and the puncture needle 4 is used for guiding the drug delivery catheter 3 to enter the subcutaneous part from a first puncture point of the skin 10, penetrate through the tumor 11 and then penetrate out from a second puncture point of the skin; a plurality of through holes 9 for communicating the inner cavity and the outside of the administration catheter 3 are arranged on the pipe wall of the middle section of the administration catheter 3, and the through holes 9 are used for outflow of liquid medicine; the first injection port 1 and the second injection port 2 are respectively embedded under the skin of the first puncture point and the second puncture point; after the drug delivery catheter with the through hole 9 guided by the puncture needle 4 is positioned in the tumor 11, the puncture needle 4 is cut off, and two ends of the drug delivery catheter 3 are respectively communicated with the first injection port 1 and the second injection port 2 through connectors;

the puncture needle 4 is an arc-shaped right-angle needle with 1/2 arc, the cross section of the needle point is a right triangle, and the design of the right-angle needle enables the puncture needle 4 to penetrate the skin 10 more easily;

the drug delivery catheter 3 is made of medical PVC (polyvinyl chloride), the diameter of the drug delivery catheter is 3mm, two ends of the drug delivery catheter are of a complete tubular structure, a plurality of through holes 9 which are used for communicating the inner cavity of the drug delivery catheter with the outside are uniformly distributed on the tube wall of the middle section, the aperture of each through hole is 100 micrometers and is used for outflow of liquid medicine, and the length of the drug delivery catheter with the through holes is selected to be a proper model according to the diameter of a tumor;

the first injection port 1 and the second injection port 2 are identical in size: height 8mm, port seat 8 bottom diameter 10mm, port seat top diameter 8mm. All including the port seat 8, the inside reservoir 7 that is equipped with of port seat 8, port seat 8 outside bottom one side is equipped with the export with reservoir 7 intercommunication, and the nearly bottom of 8 outsides of port seat keeping away from export one side is provided with fixed orifices 6 for sew up the injection port and fix in subcutaneous soft tissue. The port seat 8 is in a shape similar to a circular truncated cone, the liquid storage bag 7 is made of polyurethane, the top of the liquid storage bag 7 is exposed out of the top surface of the injection port, and one side of the bottom of the liquid storage bag 7 extends outwards from the outlet to the outside of the port seat 8 and then is connected with the connector 5. The connector 5 is pagoda-shaped, has a diameter of 3mm, one end thereof is communicated with the liquid storage bag 7, and the other end thereof can form tight connection with two ends of the administration catheter 3 with a complete tubular structure.

The utility model is suitable for an intratumoral injection local treatment of human superficial solid tumor, the basic implementation step is as follows:

(1) B ultrasonic positioning the specific position of the tumor, measuring the size and subcutaneous depth of the tumor, and marking a puncture point;

(2) Disinfecting and laying a sheet on the skin in a conventional way;

(3) Selecting puncture needles and administration catheters with proper models;

(4) Puncturing: the puncture needle guides the drug delivery catheter to enter the subcutaneous part from the first puncture point of the skin, penetrate through the tumor and then penetrate out from the second puncture point of the skin, and after the drug delivery catheter with the through hole section is positioned in the tumor, the puncture needle is cut off;

(5) Installing and implanting an injection port: cutting small openings at the first puncture point and the second puncture point, respectively connecting the two injection ports with two ends of the administration catheter, and fixing the injection ports in subcutaneous soft tissue by using sutures, wherein the injection port positioned under the skin of the first puncture point is an input end, and the injection port positioned under the skin of the second puncture point is an output end;

(6) Suturing a small incision above the injection port;

(7) The first injection port, the drug delivery catheter and the second injection port form a sustainable drug delivery system, the drug can be delivered into the tumor through the non-invasive needle via the injection ports and the drug delivery catheter (see figure 6), and the infusion pressure of the drug delivery catheter is regulated and controlled by controlling the injection pressure at the input end and the output end, so that the dispersion speed and the range of the drug in the tumor are regulated and controlled, and the drug can fully infiltrate the tumor tissue as far as possible;

(8) The administration can be continued for a plurality of times until the tumor retreats or the focus control maintenance treatment is carried out.

The above description is only for the specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto, and any person skilled in the art can easily think of the changes or substitutions within the technical scope of the present invention, and all should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (9)

1. The continuous drug administration device in the superficial solid tumor is characterized by comprising a puncture needle (4), a drug administration catheter (3), a first injection port (1) and a second injection port (2), wherein one end of the drug administration catheter (3) is connected with the puncture needle (4), and the puncture needle (4) is used for guiding the drug administration catheter (3) to enter the subcutaneous space from the first puncture point of the skin (10) and penetrate through the tumor (11) and then penetrate out from the second puncture point of the skin; a plurality of through holes (9) for communicating the inner cavity of the administration catheter (3) with the outside are formed in the middle section tube wall of the administration catheter (3), and the through holes (9) are used for outflow of liquid medicine; the first injection port (1) and the second injection port (2) are respectively embedded under the skin of the first puncture point and the second puncture point; after the drug delivery catheter with the through hole (9) guided by the puncture needle (4) is positioned in the tumor (11), the puncture needle (4) is cut off, and the two ends of the drug delivery catheter (3) are respectively communicated with the first injection port (1) and the second injection port (2) through connectors.

2. The device for continuously administering drugs into superficial solid tumors according to claim 1, characterized in that the puncture needle (4) is an arc-shaped right angle needle, and the tip section of the puncture needle (4) is a regular triangle.

3. The device for continuous drug delivery within a superficial solid tumor according to claim 1, wherein the length of the drug delivery conduit with the through hole is equal to the diameter of the tumor.

4. The superficial solid tumor intratumoral continuous drug delivery device according to claim 1, characterized in that said through holes (9) are uniformly distributed on the wall of the middle section of the drug delivery catheter, the diameter of said through holes (9) being 100 ± 10 μm.

5. The device for the continuous administration of drugs into superficial solid tumors according to claim 1, characterized in that the material of the administration catheter (3) is medical polyvinyl chloride.

6. The device for continuous drug delivery in superficial solid tumor according to claim 1, wherein the first injection port (1) and the second injection port (2) are the same and each comprises a port seat (8), a reservoir (7) is arranged in each port seat (8), an outlet communicated with the reservoir (7) is arranged on one side of the bottom outside the port seat (8), one side of the bottom of the reservoir (7) extends outwards from the outlet to the outside of the port seat (8) and then is connected with the connector (5), the top of the reservoir (7) is exposed on the top surface of the injection port, and a fixing hole (6) is further arranged on one side of the bottom outside the port seat (8) far away from the outlet.

7. The device for the continuous intratumoral administration of superficial solid tumors according to claim 6, characterized in that said harbor (8) has a truncated cone-like shape.

8. The device for the continuous administration of drugs into superficial solid tumors according to claim 6, characterized in that the material of the reservoir (7) is polyurethane.

9. The device for the continuous administration of drugs into shallow solid tumors according to claim 6, characterized in that the connector (5) has a pagoda shape.

Images