A self-steering drug delivery catheter, drug delivery system and method of use

Abstract

The application discloses a self-guiding medicine administration catheter, a medicine administration system and a use method. The self-guiding medicine administration catheter comprises a catheter main body and a guiding controller. The front part of the catheter main body is provided with a front sealing element and a medicine administration hole. The guiding controller is composed of a circular table or a circular disc, a connecting pipe, a sealing positioner, a discharge pipe and a control valve. The circular table or the circular disc has a gap between the center through hole and the connecting pipe and the catheter main body. The outer surface of the catheter main body is alternately provided with convex guiding strips and concave guiding grooves. When medicine liquid is injected into the catheter main body, the medicine liquid enters a medicine administration space and flows to the rear end. The medicine liquid forms flow modes including spiral surrounding flow, curve oscillation flow, micro eddy current and micro circulation flow under the action of the convex guiding strips and the concave guiding grooves. The flow mode, flow speed, distribution state and residence time of the medicine liquid in the medicine administration space are changed through the control valve, so that the catheter is converted between a static treatment mode and a dynamic treatment mode.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, pharmacokinetics and fluid mechanics for treating cancer, and particularly relates to a self-guiding drug delivery catheter, a drug delivery system and a use method. BACKGROUND

[0002] For patients in the early stage of cancer, surgical treatment is effective. However, for patients diagnosed with advanced cancer, the current most effective treatment regimen of surgery, chemotherapy, radiotherapy and targeted drugs can only alleviate the clinical symptoms caused by cancer metastasis, and the possibility of clinical cure is still low. The systemic treatment method of chemotherapy drugs not only brings strong side effects and reactions to patients, but also has low treatment efficiency for moderately sensitive cancers, such as rectal cancer and prostate cancer.

[0003] Traditional oral cancer treatment drugs are destroyed by gastric acid and digestive enzymes and have a first-pass effect in the liver, so that the original effective components in the drugs are greatly weakened, resulting in a significant reduction in treatment effect. Increasing the dose of oral drugs will cause greater side effects and physiological discomfort to the body. How to make cancer treatment drugs not be destroyed by gastric acid and digestive enzymes and have a first-pass effect in the liver, maximize the preservation of the original effective components in the drugs and improve the cancer treatment effect of the drugs is still a challenge.

[0004] Several innovative drugs for treating rectal cancer and prostate cancer have appeared in the market, bringing hope for the cure of patients with advanced cancer. However, there is a lack of drug delivery devices and technologies that are suitable for innovative drugs in the market.

[0005] So far, traditional medical catheters are sealed by a sealing ring between the patient's anus and the external urethral orifice and the outer surface of the catheter, and then the drug solution is infused into the patient's rectum and urethra. During the entire treatment process, the drug solution soaks the diseased tissue in the drug solution and maintains a static drug delivery treatment technology between the diseased tissue and the drug solution. The effect of the interaction between the drug and the cancer lesion and the surrounding tissue infiltrated by cancer cells is not obvious. In order to enhance the treatment effect of the drug, some catheters add an electrode plate or a magnetic plate in the drug delivery space to create a temperature difference between the drug solution near the electrode plate and the drug solution far away from the electrode plate, so that the drug solution in the drug delivery space occurs natural convection, and the interaction between the drug solution and the diseased tissue is enhanced. However, the space between the urethra and the catheter is limited, which greatly limits the clinical application of this technology to prostate cancer, and the electrode plate brings problems of clinical safety, operation difficulty and high use cost. SUMMARY

[0006] The self-guiding drug delivery catheter, drug delivery and treatment device and system of the present application can change the flow direction of the drug liquid in the drug delivery space by the curved convex flow guide strip and the concave flow guide groove on the outer surface of the catheter body, and can obtain different flow patterns. The drug liquid and the cancer lesion and the surrounding tissue infiltrated by cancer cells kill the cancer cells through a dynamic interaction mode, and carry away the killed cancer cells and the small tissue fragments with the dead cancer cells, and then the killed cancer cells and the small tissue fragments with the dead cancer cells leave the drug delivery space through the control valve in the flow guide controller. The flow guide controller can change the flow pattern, distribution state, flow speed and residence time of the drug liquid in the drug delivery space through the control valve. The dynamic interaction mode between the drug liquid and the cancer cells greatly enhances the treatment efficiency and effect of the drug delivery catheter on the cancer. The dynamic interaction treatment technology of the self-guiding drug delivery catheter can keep the drug liquid concentration in the cancer lesion and the surrounding tissue infiltrated by cancer cells in time, and the impact, interference, replacement and separation of the drug liquid on the cancer cells and the surrounding tissue infiltrated by cancer cells can be continuous, which not only solves the problems of loss of original effective components, reduction of treatment intensity and treatment effect in traditional oral cancer treatment, but also greatly improves the treatment effect and efficiency of the cancer. The present application can be used for treating (not limited to) rectal cancer and prostate cancer, and has the characteristics of simple device structure, convenient operation, higher treatment effect, lower cost, easier popularization and popularization, etc.

[0007] The self-guiding drug delivery catheter comprises a hollow catheter body, a front closed part is arranged at the front part of the catheter body, a drug delivery hole is arranged at the rear part of the catheter body close to the front closed part, a catheter joint is arranged at the rear end of the catheter body, and the self-guiding drug delivery catheter further comprises a flow guide controller which comprises a circular truncated cone or a circular disc with a rotating curved surface, a connecting pipe, a sealing positioner, a discharge pipe and a control valve; the diameter of the central through hole of the circular truncated cone or the circular disc is equal to the inner diameter of the connecting pipe and greater than the diameter of the outer surface of the catheter body;

[0008] The front end of the connecting pipe is located at the rear end of the circular truncated cone or the circular disc, a drug discharge hole is arranged on the connecting pipe, the front end of the discharge pipe is connected with the drug discharge hole, and the rear end of the discharge pipe is provided with the control valve;

[0009] The sealing positioner has two states of loosening and locking. When the state is loosening, the flow guide controller can move forward and backward along the outer circumferential surface of the catheter body in the axial direction; when the state is locking, the sealing positioner closes the gap between the inner surface of the connecting pipe and the outer surface of the catheter body at the rear end of the connecting pipe, and fixes the position of the flow guide controller on the catheter body;

[0010] The front closure, the flow guide controller, and the outer surface of the catheter body jointly form a drug delivery space in the patient's body with the inner surface of the natural cavity of the patient.

[0011] The outer surface of the catheter body is alternately provided with convex flow guide strips and concave flow guide grooves.

[0012] Preferably, when the drug solution is injected into the catheter body, the drug solution enters the drug delivery space from the drug delivery hole and flows towards the rear end of the catheter body, and the drug solution forms flow patterns including spiral circumferential flow, curved oscillation flow, micro eddy current, and micro circulation flow under the action of the convex flow guide strips and the concave flow guide grooves; the flow guide controller changes the flow pattern, distribution state, flow speed, and residence time of the drug solution in the drug delivery space through the control valve, thereby realizing the conversion of the catheter between the static treatment and dynamic interaction treatment modes.

[0013] Preferably, when the catheter body is a rectal catheter, the front part of the flow guide controller is shaped as a circular truncated cone of a rotational surface with the side surface inwardly concave, the small end of the circular truncated cone is the front end of the circular truncated cone, and the front end faces the front end of the rectal catheter; the side surface of the circular truncated cone is provided with a soft sealing gasket.

[0014] When the catheter body is a prostate catheter, the front part of the flow guide controller is shaped as a circular disc of a rotational surface with the side surface outwardly convex, the front end of the circular disc is open towards the front end of the prostate catheter; the inner surface of the circular disc is provided with a soft sealing gasket.

[0015] Preferably, the sealing positioner includes two half-circular tubes arranged in two parts, one end of each of the two half-circular tubes is connected with a pair of hinge hinges arranged at the rear part of the connecting pipe, the other end of each of the two half-circular tubes is provided with a buckle having two states of locking and loosening, the inner wall of each of the two half-circular tubes is provided with a soft sealing gasket, the inner surface diameter of the soft sealing gasket is smaller than the outer surface diameter of the catheter body, and the thickness of the soft sealing gasket is greater than the gap between the inner surface of the connecting pipe and the outer surface of the catheter body; when the buckle is in the locking state, the two half-circular tubes are combined into one, the soft sealing gasket closes the gap between the inner surface of the connecting pipe and the outer surface of the catheter body at the rear end of the connecting pipe, and simultaneously fixes the position of the flow guide controller on the catheter body; when the buckle is in the loosening state, the two half-circular tubes are loosened, and the flow guide controller can move axially forward and backward along the outer peripheral surface of the catheter body.

[0016] Preferably, the front closure is an airbag located on the front outer surface of the catheter body, a small part of the catheter body in front of the airbag, a cap with a circular arc shape is arranged on the head end of the catheter body in front of the airbag to seal the head end; the rear part of the catheter body is provided with a branch catheter, and a thin catheter is arranged in the branch catheter and the inner channel of the catheter body, and the thin catheter is connected with the airbag; by injecting water or air into the thin catheter, the airbag is inflated to seal the front end of the drug delivery space;

[0017] A plurality of the drug delivery holes are located on the catheter body behind the airbag.

[0018] Alternatively,

[0019] The front closure is a hollow elliptical ball located at the front end of the catheter body; the long axis of the hollow elliptical ball coincides with the center line of the catheter body, and the short axis is greater than the outer diameter of the catheter body; a plurality of the drug delivery holes are located on the catheter body close to the hollow elliptical ball.

[0020] Preferably, the convex flow guide strips and the concave flow guide grooves are respectively a plurality of, each of the convex flow guide strips and the concave flow guide grooves is in a curved shape and independent of each other; the curved shapes of each of the convex flow guide strips and the concave flow guide grooves are the same or different.

[0021] Preferably, a plurality of the convex flow guide strips are distributed in the front region of the catheter body.

[0022] A plurality of the concave flow guide grooves are distributed in the front and middle regions of the catheter body.

[0023] In the front region of the catheter body, one convex flow guide strip and one concave flow guide groove are arranged alternately, and the frontmost end is a convex flow guide strip.

[0024] Preferably, the curved length of each of the convex flow guide strips and the concave flow guide grooves is less than four times the diameter of the catheter body.

[0025] When the catheter body is a rectal catheter, the height of the convex flow guide strip is less than 10 mm, and the tangent of any point on the central curve of the tail end part of the convex flow guide strip and the concave flow guide groove in a plane coinciding with the center axis of the catheter body and perpendicular to the radial direction of the point has an included angle with the center axis of the drug delivery catheter body less than 180°.

[0026] When the catheter body is a prostatic catheter, the height of the convex flow guide strip is less than 2 mm, and the tangent of any point on the central curve of the tail end part of the convex flow guide strip and the concave flow guide groove in a plane coinciding with the center axis of the catheter body and perpendicular to the radial direction of the point has an included angle with the center axis of the drug delivery catheter body less than 120°.

[0027] Another aspect of the present application provides a drug delivery system, comprising a drug solution supply bag, a drug delivery tube, a drug solution recovery bag, a drug discharge tube and a self-guided drug delivery catheter as described above;

[0028] One end of the drug delivery tube is connected to the drug solution supply bag, and the other end is connected to the catheter connector at the rear end of the catheter body; the drug delivery tube is provided with a drug delivery valve;

[0029] One end of the drug discharge tube is connected to the drug solution recovery bag, and the other end is connected to the control valve at the rear end of the discharge tube in the flow controller.

[0030] The third aspect provides a method for using the drug delivery system as described above, comprising the following steps:

[0031] S1. When the catheter body reaches the drug delivery site, open the drug delivery valve and the control valve until the drug solution flows out of the control valve, indicating that the drug solution has filled the drug delivery space;

[0032] S2. Close the control valve for a target time T1, and during the T1 period, the drug solution is in a static state in the drug delivery space, the cancer lesion and the surrounding tissue infiltrated by cancer cells are soaked in the drug solution;

[0033] S3. Open the control valve for a target time T2, and during the T2 period, the drug solution is in a flowing state in the drug delivery space, the drug solution and the cancer lesion and the surrounding tissue infiltrated by cancer cells interact dynamically and kill cancer cells, and then carry away the killed cancer cells and small tissue fragments carrying the dead cancer cells from the lesion tissue, in turn through the central through hole of the circular cone or disc, the gap between the inner surface of the connecting tube and the outer surface of the catheter body, the discharge tube and the control valve, and out of the drug delivery space;

[0034] S4. Cycle the closing mode of the control valve in step S2 and the opening mode of the control valve in step S3 until the drug solution in the drug solution supply bag is used up;

[0035] The closing and opening times of the control valve during the cycle of step S4 are consistent with or inconsistent with the T1 and T2 times of steps S2 and S3.

[0036] The self-guided drug delivery catheter provided by the present application not only can realize the static treatment mode of the drug solution for the cancer lesion and the surrounding tissue infiltrated by cancer cells, but also can realize the dynamic interaction treatment mode. BRIEF DESCRIPTION OF DRAWINGS

[0037] Figure 1 A schematic diagram of a ball and rectal catheter structure is provided for the preferred embodiment of the present application;

[0038] Figure 2 A schematic diagram of a balloon rectal catheter in a sleep state according to a preferred embodiment of the present application;

[0039] Figure 3 A schematic diagram of a balloon rectal catheter in a working state according to a preferred embodiment of the present application; Figure 2

[0040] Figure 4 A schematic diagram of a convex flow guide bar and a concave flow guide groove structure according to a preferred embodiment of the present application;

[0041] Figure 5 A schematic diagram of a static soaking treatment technique of a drug solution in a drug application space according to a preferred embodiment of the present application;

[0042] Figure 6 A schematic diagram of a dynamic interaction treatment technique of a drug solution in a drug application space under multiple flow modes according to a preferred embodiment of the present application;

[0043] Figure 7 A schematic diagram of formation and development of a drug solution flow mode at a tail end of a convex flow guide bar according to the present application;

[0044] Figure 8 A schematic diagram of a front view of a rectal catheter flow guide controller according to a preferred embodiment of the present application;

[0045] Figure 9 A schematic diagram of a side view of a rectal catheter flow guide controller according to a preferred embodiment of the present application;

[0046] Figure 10 A schematic diagram of a front view of a prostate catheter flow guide controller according to a preferred embodiment of the present application;

[0047] Figure 11 A schematic diagram of a rectal catheter treatment technique and working principle according to a preferred embodiment of the present application; Figure 3

[0048] Figure 12 A schematic diagram of a drug application system structure according to a preferred embodiment of the present application.

[0049] ​​Among them, 1-catheter body; 2-hollow elliptical ball; 3-catheter connector; 4-flow guide controller; 5-drug delivery hole; 6-concave flow guide groove; 7-convex flow guide strip; 9-air bag; 10-cap; 11-branch catheter; 12-thin catheter; 14-drug delivery space; 15-drug solution flow velocity distribution curve; 16-spiral flow mode; 17-stratospheric flow mode; 18-curve oscillation flow mode; 19-micro-vortex and micro-circulation mode; 1 9'-micro-vortex mode; 19"-micro-circulation mode; 420-connecting tube; 421-semicircular tube; 422-hinge; 423-clip; 424-soft sealing sheet; 425-discharge tube; 426-control valve; 427-rectal catheter soft sealing gasket; 428-prostate catheter soft sealing gasket; 29-rectum; 30-drug discharge tube; 31-drug delivery tube; 32-drug delivery valve; 33-drug solution supply bag; 34-drug solution recovery bag. DETAILED DESCRIPTION

[0050] In order to better understand the technical solution of the present application, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0051] The present invention provides a self-guiding drug delivery catheter, such as Figures 1-11 As shown, the catheter body comprises a hollow catheter body 1 and a flow control device 4. A front closure member is provided at the front of the catheter body, and a drug delivery port 5 is provided in the catheter body near the rear of the front closure member. After the catheter body is inserted into the patient's body at the medication delivery site, the front closure member is positioned within the patient's body, allowing the injection of medication through the hollow interior of the catheter body 1 and out of the drug delivery port 5. The front closure member can be a conventional airbag, hollow ellipsoidal sphere, or the like, sealing the front end of the medication delivery space. The rear end of the catheter body 1 is connected to a catheter connector 3.

[0052] Preferably, the catheter body 1 is made of a polymer material and is coated with a hydrophilic coating on the outer surface, so that it is easy to insert into the human body and becomes a consumable material that can be discarded after use.

[0053] The flow diversion controller 4 is composed of a truncated cone with an inwardly concave rotating curved surface or a disc with an outwardly convex rotating curved surface, a connecting pipe 420, a sealing positioner, a discharge pipe 425, and a control valve 426. The diameter of the central through hole of the cone or disc is equal to the inner diameter of the connecting pipe 420 and is larger than the diameter of the outer surface of the catheter body 1. There is a gap between the central through hole of the cone or disc, the inner surface of the connecting pipe 420, and the outer surface of the catheter body 1. The catheter body 1 passes through the central through hole of the cone or disc and the connecting pipe 420, and the flow diversion controller 4 can move forward and backward along the axial direction of the catheter body 1. The front end of the connecting pipe 420 is located at the rear end of the cone or disc, and a drug discharge hole is provided on the connecting pipe 420. The front end of the discharge pipe 425 is connected to the drug discharge hole, and the rear end of the discharge pipe is provided with a control valve 426.

[0054] The sealing positioner has two states of loosening and locking. When in the loosening state, the flow controller 4 can move along the outer surface of the catheter body 1 in the axial direction until it reaches the target position. When in the locking state, the sealing positioner closes the gap between the inner surface of the connecting tube 420 and the outer surface of the catheter body 1 at the rear end of the connecting tube 420, so that the drug solution can only flow out of the drug discharge hole, and at the same time, the position of the flow controller on the catheter body 1 is fixed.

[0055] As a preferred structure, the sealing positioner comprises two semicircular tubes 421 arranged in an upper and lower split manner. One end of the two semicircular tubes 421 is movably connected to the rear part of the connecting tube 420, preferably by a pair of hinge hinges 422 arranged at the rear part of the connecting tube 420, so that the semicircular tubes 421 can rotate around the rear part of the connecting tube 420, thereby being able to open or be integrated. The other end of the two semicircular tubes 421 is provided with a buckle 423 having two states of locking and loosening. The inner walls of the two semicircular tubes 421 are each provided with a soft sealing piece 424. The inner surface diameter of the soft sealing piece 424 is smaller than the outer surface diameter of the catheter body 1, and the thickness of the soft sealing piece 424 is greater than the gap between the inner surface of the connecting tube 420 and the outer surface of the catheter body 1. When the buckle 423 is in the locking state, the two semicircular tubes 421 are integrated, and the soft sealing piece 424 closes the gap between the inner surface of the connecting tube 420 and the outer surface of the catheter body 1 at the rear end of the connecting tube 420, and at the same time, the position of the flow controller 4 on the catheter body 1 is fixed. When the buckle 423 is in the loosening state, the two semicircular tubes 421 are loosened, and the flow controller 4 can move in the axial direction on the catheter body 1.

[0056] The front closure, the flow controller, and the outer surface of the catheter body together form a drug application space 14 in the patient's body with the inner surface of the natural cavity of the patient.

[0057] The outer surface of the catheter body is alternately provided with convex flow guide strips 7 and concave flow guide grooves 6. When the drug solution is injected into the catheter body, the drug solution enters the drug application space from the drug administration hole and flows towards the rear end of the catheter body. Under the action of the alternately arranged convex flow guide strips and concave flow guide grooves on the surface of the catheter body, the drug solution forms flow patterns including spiral circumferential flow, curved oscillation flow, micro eddy current, and micro circulation flow. The flow controller changes the flow pattern, distribution state, flow speed, and residence time of the drug solution in the drug application space by controlling the valve, thereby realizing the conversion of the catheter between the static drug application and dynamic drug application modes, and the static treatment and dynamic interaction treatment modes.

[0058] The self-guiding drug delivery catheter provided in the application can not only realize the static treatment mode of the drug liquid for the cancer lesions and the surrounding tissues infiltrated by cancer cells, but also realize the dynamic interaction treatment mode. Specifically, the convex guiding strips and the concave guiding grooves are alternately arranged on the outer surface of the catheter body. When the drug liquid is injected into the catheter body, the drug liquid flows into the drug delivery space 14 from the multiple drug delivery holes 5 and flows to the rear end of the catheter body. Under the action of the convex guiding strips and the concave guiding grooves alternately arranged on the surface of the catheter body, the drug liquid forms a flow mode including spiral circumferential flow, curve oscillation flow, micro eddy current and micro circulation flow. The flow mode, distribution state, flow speed and residence time of the drug liquid in the drug delivery space are changed by the control valve at the rear end of the discharge pipe through the flow control device, so that the catheter is switched between the static drug delivery mode and the dynamic drug delivery mode, and between the static treatment mode and the dynamic interaction treatment mode. Specifically, after the drug delivery space is filled with the drug liquid, the control valve is closed, the drug liquid is static in the drug delivery space, the cancer lesions and the surrounding tissues infiltrated by cancer cells are soaked in the drug liquid for a period of time, and a static drug delivery and static soaking treatment mode is formed. After the control valve is opened, the drug liquid in the drug delivery space starts to flow in a spiral circumferential, curve oscillation, micro eddy current and micro circulation flow mode in a local range, and forms a dynamic interaction between the cancer lesions and the surrounding tissues infiltrated by cancer cells, which has impact, interference, replacement and stripping at the same time, greatly improving the treatment effect of the drug liquid. The dynamic interaction mode between the drug liquid and the cancer lesions and the surrounding tissues infiltrated by cancer cells kills the cancer cells, and then carries away the killed cancer cells and the small tissue fragments carrying the dead cancer cells separated from the diseased tissues, out of the drug delivery space and the catheter body through the control valve at the rear end of the discharge pipe in the flow control device, and into the drug liquid recovery bag.

[0059] Therefore, the self-guiding drug delivery catheter provided in the application can kill cancer cells in a static soaking and dynamic interaction mode between the drug liquid and the cancer lesions and the surrounding tissues infiltrated by cancer cells, and carry away the killed cancer cells and the small tissue fragments carrying the dead cancer cells separated from the diseased tissues, out of the drug delivery space and the catheter body through the discharge pipe and the control valve. As can be understood by those skilled in the art, in order to prevent the discharged drug liquid from polluting the human body and the environment, the discharged drug liquid is collected by the drug liquid recovery device.

[0060] As Figure 5 shown is a schematic diagram of the static soaking treatment technology of the drug liquid in the drug delivery space. In one drug delivery space 14 shown in the figure, the drug liquid is in a static state, the cancer lesions and the surrounding tissues infiltrated by cancer cells are soaked in the drug liquid, the drug liquid directly contacts the cancer cells, but the exchange between the drugs and the concentration between the layers and the regions of the drug liquid is slow.

[0061] ​The convex flow guiding strips and the concave flow guiding grooves on the surface of the catheter body change the flow direction of the drug liquid in the drug application space and generate a variety of different flow patterns. Specifically, the initial flow pattern of the drug liquid after entering the drug application space is the laminar flow pattern, and after the drug liquid flows through the curved convex flow guiding strips and the concave flow guiding grooves on the surface of the catheter body, the drug liquid on and near the surface of the catheter body begins to flow along the curved direction of the convex flow guiding strips and the concave flow guiding grooves; when the drug liquid reaches the tail end of the convex flow guiding strips and the concave flow guiding grooves, because of the sudden disappearance of the convex flow guiding strips and the concave flow guiding grooves, the tail end disturbance is formed, the drug liquid relies on the kinetic energy it has to begin to exchange and mix with the drug liquid flowing in different directions around it, the viscosity and kinetic energy of the drug liquid cause the flow direction of the same layer and the upper layer of the drug liquid to change, and after mixing, a variety of different flow patterns are generated. The tail end disturbance of the concave flow guiding groove is different from that of the convex flow guiding strip, and after the drug liquid is mixed after the tail end disturbance of the convex flow guiding strip and the concave flow guiding groove, the disturbance effect of the drug liquid at the tail end of the convex flow guiding strip is enhanced and the micro-vortex and micro-circulation effects are more obvious. Along the direction from the surface of the catheter body to the natural cavity mucosa surface of the patient, the distribution of the flow pattern of the drug liquid is: the laminar flow pattern 17, the parallel flow pattern of a very thin layer of drug liquid next to the surface of the catheter body; the spiral wrapping flow pattern 16, the drug liquid wrapping the catheter body along the curved shape of the convex flow guiding strip, and the flow pattern on and near the surface of the catheter body; the curved oscillation flow pattern 18, the curved oscillation flow pattern in different directions after the spiral wrapping flow of the drug liquid mixes with the laminar flow of the drug liquid flowing to the rear end; the micro-vortex and micro-circulation flow pattern 19, the micro-vortex and micro-circulation flow pattern formed after the drug liquid leaving the tail end of the convex flow guiding strip and the concave flow guiding groove mixes with the laminar flow of the drug liquid flowing to the rear end. The very thin layer of drug liquid next to the natural cavity mucosa surface is in a relatively static state with the mucosa surface, and the flow speed of the drug liquid is zero. The area between the natural cavity mucosa surface and the micro-vortex and micro-circulation flow pattern of the drug liquid is a mixed pattern of the curved oscillation flow pattern and the micro-vortex and micro-circulation. The kinetic energy exchange and assistance of the curved oscillation flow and the micro-vortex and micro-circulation flow cause the drug liquid from various directions above the natural cavity mucosa surface to continuously impact, disturb and replace the laminar static drug liquid next to the natural cavity mucosa surface and the diseased tissue; the drug liquid and the cancer cells and the tissues carrying cancer cells form a dynamic interaction with impact, disturbance, replacement and stripping. The drug liquid and the cancer lesions and the surrounding tissues infiltrated by cancer cells kill cancer cells through direct contact and dynamic interaction, and carry away the killed cancer cells and small tissue fragments carrying dead cancer cells separated from the diseased tissue.

[0062] As Figure 6The dynamic interaction treatment technology of the drug liquid in the drug delivery space is shown. In the drug delivery space 14, the surface of the catheter body 1 is provided with the convex flow guide strip 7 and the concave flow guide groove 6. The drug liquid with viscosity and kinetic energy exchange and mixing fills the drug delivery space 14. When the control valve is opened, the flow distribution curve 15 between the surface of the catheter body 1 and the natural cavity mucosa surface of the patient shows that the flow speed of the drug liquid on the surface of the catheter body 1 and the natural cavity mucosa surface is zero, and the flow speed in the middle of the drug delivery space 14 is the fastest. The convex flow guide strip 7 and the concave flow guide groove 6 on the surface of the catheter body 1 make the drug liquid on and near the surface of the catheter body 1 spiral around along the curve direction of the convex flow guide strip 7 and the concave flow guide groove 6, forming a spiral around flow mode 16 on and near the surface of the catheter body 1. When the drug liquid passes through the tail end of the convex flow guide strip 7 and the concave flow guide groove 6, the drug liquid appears disturbance at the tail end and mixes with the drug liquid in the same layer and the upper layer. The result of the mixing is that the curve oscillation flow mode 18 and the micro eddy current and micro circulation mode 19 in the middle region appear.

[0063] Figure 7 The formation and development of the drug liquid flow mode at the tail end of the convex flow guide strip are shown. In the drug delivery space, when the drug liquid flows through the convex flow guide strip 7, a small part of the drug liquid in the horizontal flow layer flow mode continues to flow forward in the horizontal flow layer flow mode 17 beyond the head end of the convex flow guide strip 7, and most of the drug liquid flows along the curve-shaped convex flow guide strip 7 and reaches the tail end of the convex flow guide strip 7. At the tail end of the convex flow guide strip 7, the drug liquid is divided into multiple streams flowing in different directions and mixing with the drug liquid in the same layer and the upper layer. The drug liquid flow mode after the mixing shown in the figure has the horizontal flow layer flow mode 17, the spiral around flow mode 16, the curve oscillation flow mode 18, the micro eddy current flow mode 19', and the micro circulation flow mode 19''.

[0064] Because the patient's body or treatment site changes continuously during the treatment, the change breaks the original physical state and balance of the drug delivery space, the drug liquid flow mode and the distribution state. When the patient's body or treatment site returns to a new relatively stable state, a new drug liquid flow mode and distribution state in the drug delivery space restart, until a new balance and stable state is reached. The different drug liquid flow modes and distribution states in the drug delivery space depend on the viscosity of the drug liquid, the curve shape and height of the convex flow guide strip, the flow speed of the drug liquid in the drug delivery space, the distance between the surface of the drug delivery catheter body and the natural cavity mucosa surface of the patient, the residence time, and the flatness and smoothness of the natural cavity mucosa surface of the patient.

[0065] The convex flow guide strip changes the flow mode and flow direction of the horizontal flow layer drug liquid and generates disturbance at the tail end, thereby generating different flow modes. The concave flow guide groove provides more kinetic energy and assistance for the tail end disturbance of the convex flow guide strip, and enhances the effect of the tail end disturbance of the convex flow guide strip.

[0066] The micro-vortex and micro-circulation combined with the curved oscillation flow pattern of the drug solution impacts, interferes, displaces and peels off the cancer lesions and the surrounding tissues infiltrated by cancer cells from various directions on the patient's mucosal surface. This dynamic interaction treatment technology is better and more efficient than the static treatment technology of the conventional drug delivery catheter. In the conventional static soaking treatment technology, the driving force and strength of the mutual exchange between the drug solutions in different layers and areas in the stratosphere are obviously insufficient.

[0067] Another function of the concave flow guide groove provided in the present application is lubrication, which can greatly reduce the pain caused to the patient when the catheter is inserted into and withdrawn from the natural cavity of the patient, especially the prostate catheter. Before inserting the prostate catheter into the urethra of the patient, a thin layer of lubricating oil is first applied to the surface of the prostate catheter, part of which is trapped in the concave flow guide groove, and then the prostate catheter is slowly rotated and pushed forward along the curved direction of the convex flow guide strip to be inserted into the urethra of the male patient. The lubricating oil in the concave flow guide groove that has entered the urethra of the patient can provide lubrication for the part of the urethra that has not yet been inserted, causing less pain to the patient than the conventional catheter, especially to the male patient. The smooth change of the outer surface of the convex flow guide strip has a limited impact on the pain of the patient with the assistance of the lubricating oil.

[0068] Further preferably, the control valve 426 is directly connected with the drug discharge pipe 30 and the drug recovery bag 34, and can collect the discharged drug solution.

[0069] As can be understood by those skilled in the art, the rotating circular table or disc in the flow guide controller 4 and the connecting pipe 420 can be integrally formed, or the two components can be bonded together.

[0070] As preferred, the flow guide controller is made of a high polymer material, becoming a consumable that can be discarded after use.

[0071] The flow guide controller 4 in the present application can be in contact with the human body to position the catheter body. The sealing positioner can fix the position of the flow guide controller on the catheter body, and can also seal the rear end of the drug delivery space. The gap between the central through hole of the circular table or disc and the inner surface of the connecting pipe and the outer surface of the catheter body provides a channel for the drug solution to flow to the drug discharge hole and the discharge pipe. Under the condition of sealing the rear end of the drug delivery space, the control valve at the rear end of the discharge pipe can be closed and opened to quickly switch the catheter between the static drug delivery mode and the dynamic drug delivery mode, and between the static treatment mode and the dynamic interaction treatment mode.

[0072] As preferred, a soft sealing gasket is provided on the front end face of the flow guide controller 4, which can enhance the sealing effect between the flow guide controller 4 and the human skin, preventing the drug solution from flowing out of the gap between the flow guide controller and the human skin.

[0073] The shape of the front part of the flow controller varies according to the catheter body. Specifically, when the catheter body is a rectal catheter, the front part of the flow controller 4 is shaped as a circular truncated cone of a rotary curved surface with the side surface concave inward, the small end of the circular truncated cone being the front end of the circular truncated cone, which faces the front end of the catheter body, and the front end of the circular truncated cone having a small diameter. The small diameter part of the front end of the circular truncated cone can be partially inserted into the anus of the patient to prevent the drug from flowing out. When the catheter body is a prostatic catheter, the front part of the flow controller 4 is shaped as a circular disc of a rotary curved surface with the side surface convex outward. The front end of the circular disc is open toward the front end of the prostatic catheter.

[0074] As mentioned above, the soft sealing gasket is arranged on the side surface of the circular truncated cone (rectal catheter soft sealing gasket 427) and the inner surface of the circular disc (prostatic catheter soft sealing gasket 428), which not only prevents the drug from leaking from the external urethral orifice, but also makes the patient feel more comfortable during use.

[0075] The flow controller provided by the present application is an active controllable leakage positioning device. Not only is the rear end of the drug delivery catheter sealed, but the drug liquid can also be artificially controlled to stay or leave the drug delivery space through manual or automatic operation, the flow mode, flow state, flow speed and residence time of the drug liquid in the drug delivery space are changed, and the conversion between the static treatment and dynamic treatment modes of the catheter is realized.

[0076] The front closure can be achieved by using the prior art, and the present application provides two preferred schemes:

[0077] 1. Air bag drug delivery catheter body: as shown in Figures 2-3 , the front closure is an air bag 9 located at the front part of the catheter body 1, a small part of the catheter body is located in front of the air bag 9, the front end of the catheter body 1 in front of the air bag is closed, and a circular arc-shaped cap 10 can be used to close the front end of the catheter body; a branch catheter 11 is arranged at the rear part of the catheter body 1, a fine catheter 12 is arranged in the branch catheter 11 and the catheter body 1, and the fine catheter 12 is connected with the air bag 9; water or gas is injected into the fine catheter to inflate the air bag 9 and close the front end of the drug delivery space. The drug delivery holes 5 are arranged on the catheter body 1 behind the air bag 9, and the drug delivery holes 5 are a plurality of small holes. A plurality of convex flow guide strips 7 and concave flow guide grooves 6 are arranged on the outer surface of the catheter body 1.

[0078] 2. Ball drug delivery catheter body: as shown in Figure 1 , the front closure is a hollow elliptical ball 2 located at the front end of the catheter body 1; further preferably, the long axis of the hollow elliptical ball 2 coincides with the center line of the catheter body, and the short axis is larger than the outer diameter of the catheter body; a plurality of drug delivery holes 5 are arranged on the catheter body 1 close to the hollow elliptical ball 2.

[0079] Preferably, a length scale is provided on the outer surface of the catheter body for use in cooperation with the flow control device to ensure that the depth of the catheter body into the natural cavity of the patient has exceeded the depth of the cancerous lesion and the tissue infiltrated by cancer cells so that the cancerous lesion and the surrounding tissue infiltrated by cancer cells are all located in the drug delivery space. The zero point of the length scale is located at the trailing edge of the hollow oval ball or the front balloon at the head end of the catheter body.

[0080] As shown in Figure 4 Preferably, the convex flow guide strips 7 and the concave flow guide grooves 6 are each a plurality of, each of which is in a curved shape and independent of each other. The curved shape of each of the convex flow guide strips 7 and the concave flow guide grooves 6 can be the same or different.

[0081] Further preferably, the plurality of convex flow guide strips 7 are distributed in the front region of the catheter body, and the plurality of concave flow guide grooves 6 are distributed in the front and middle regions of the catheter body. In the front region of the catheter body, a convex flow guide strip and a concave flow guide groove are arranged alternately, and the convex flow guide strip is located at the most front end.

[0082] The convex flow guide strips and the concave flow guide grooves in the front region mainly play a flow guiding role, and the concave flow guide grooves also have a lubricating function. Therefore, in addition to the front region, the concave flow guide grooves are preferably also provided in the middle region. The size of the convex flow guide strips and the concave flow guide grooves varies according to the catheter body, and specifically: the curved length of each of the convex flow guide strips and the concave flow guide grooves is less than four times the diameter of the catheter body; and the depth of the concave flow guide grooves is less than the wall thickness of the catheter body.

[0083] When the catheter body is a rectal catheter, the height of the convex flow guide strip is less than 10 mm, and the tangent of any point on the central curve of the tail end portion of the convex flow guide strip and the concave flow guide groove projects on a plane coinciding with the central axis of the catheter body and perpendicular to the radial direction of the point, and the included angle between the projection and the central axis of the drug delivery catheter body is less than 180°.

[0084] When the catheter body is a prostatic catheter, the height of the convex flow guide strip is less than 2 mm, and the tangent of any point on the central curve of the tail end portion of the convex flow guide strip and the concave flow guide groove projects on a plane coinciding with the central axis of the catheter body and perpendicular to the radial direction of the point, and the included angle between the projection and the central axis of the drug delivery catheter body is less than 120°.

[0085] As can be understood by those skilled in the art, the curvature of the surface of the convex flow guide strips and the concave flow guide grooves on the surface of the catheter body is continuous and smooth. The convex flow guide strips and the concave flow guide grooves can also use other flow guide members that can achieve the same function.

[0086] The application also provides a drug delivery system, as shown in Figure 12As shown, the system includes a drug solution supply bag 33, a drug solution delivery tube 31, a drug solution recovery bag 34, a drug solution discharge tube 30, and a self-guided flow drug delivery catheter as described above; one end of the drug solution delivery tube 31 is connected to the drug solution supply bag 33, and the other end is connected to the catheter joint 3 at the rear end of the catheter body of the self-guided flow drug delivery catheter; the drug solution delivery tube 31 is provided with a drug delivery valve 32; one end of the drug solution discharge tube 30 is connected to the drug solution recovery bag 34, and the other end is connected to the control valve 426 at the rear end of the discharge tube 425. The drug solution delivery tube and the drug solution discharge tube are preferably flexible tubes.

[0087] By adjusting the drug delivery valve 32, the drug solution can be input into the catheter body and stopped, and the input flow rate can be adjusted. By adjusting the control valve 426, the static drug delivery and dynamic drug delivery modes in the drug delivery space can be quickly switched between each other, and the static treatment and dynamic interaction treatment modes can be quickly switched between each other.

[0088] Specifically: after the drug delivery valve 32 is opened, the drug solution in the drug solution supply bag 33 enters the inner cavity of the catheter body 1 through the drug solution delivery tube 31 and the catheter joint 3, enters the drug delivery space through the drug delivery hole 5, and after the drug delivery space is filled with the drug solution, the control valve 426 is closed, so that the cancer lesion and the surrounding tissue infiltrated by cancer cells are statically soaked in the drug solution. The control valve 426 is opened, and the drug solution in the drug delivery space starts to flow in a spiral surrounding, curved oscillation, micro-eddy current and micro-circulation flow mode in a local range, and the drug solution and the cancer lesion and the surrounding tissue infiltrated by cancer cells kill cancer cells through direct contact and dynamic interaction, and then carry away the killed cancer cells and small tissue fragments carrying the dead cancer cells separated from the diseased tissue, sequentially pass through the central through hole of the circular cone or disc and the gap between the inner surface of the connecting tube and the outer surface of the catheter body, the drug discharge hole, the discharge tube 425 and the control valve 426, and leave the drug delivery space and the catheter body 1, and the discharged drug solution enters the drug solution recovery bag 34 through the drug solution discharge tube 30.

[0089] The application also provides a use method of the above-mentioned drug delivery system, which comprises the following steps: S1. When the catheter body reaches the drug delivery site, the drug delivery valve and the control valve are opened until the drug solution flows out of the control valve, indicating that the drug delivery space is filled with the drug solution; S2. The control valve is closed for a target time T1, and during the T1 period, the drug solution is in a static treatment state, and the cancer lesion and the surrounding tissue infiltrated by cancer cells are soaked in the drug solution; S3. The control valve is opened for a target time T2, and during the T2 period, the drug solution is in a flowing state, and the drug solution and the cancer lesion and the surrounding tissue infiltrated by cancer cells are in a dynamic interaction treatment mode; S4. The control valve closing mode of step S2 and the control valve opening mode of step S3 are cycled until the drug solution in the drug solution supply bag is completely used up; the control valve closing and opening time in the step S4 cycle process is consistent with or inconsistent with the T1 and T2 time of steps S2 and S3.

[0090] The application provides a specific control method for a drug administration valve and a control valve in a 30-45 minute treatment session. First, the drug administration valve and the control valve are opened for 2-3 minutes until the drug solution flows out of the control valve, indicating that the drug solution has filled the drug administration space. Second, the control valve is closed for 10-15 minutes, and the cancer lesion and the surrounding tissue infiltrated by cancer cells are soaked in the drug solution. Third, the control valve is opened for 5 minutes. Finally, the control valve is closed for 1 minute. The above-mentioned cycle of opening the control valve for 5 minutes and closing the control valve for 1 minute is repeated until the drug solution in the drug solution supply bag is completely used up.

[0091] The above-mentioned method combines the traditional static direct contact treatment technology of the drug administration catheter and the dynamic interaction treatment technology.

[0092] It should be noted that the cancer lesion to which the drug administration catheter is applied can be cancer tissue and tissue infiltrated by cancer cells in the mucosa layer, muscle layer or serosa layer of the inner surface of an organ, or can be polypus or hard cancer tissue growing in the organ in the shape of a cone, sheet, egg, petal, bean or any shape; or can be cancer tissue growing in the tissue of an organ.

[0093] Compared with the prior art, the application has the following advantages:

[0094] (1) The target drug treatment for rectal cancer and prostate cancer solves the problem of reduced drug treatment effect caused by the destruction and loss of the effective components in the oral drug due to the biochemical effects of a large amount of gastric acid, digestive enzymes and liver first-pass effect, etc.

[0095] (2) Compared with the traditional whole-body "rain and dew" drug administration method, the drug directly contacts the cancer lesion and the tissue infiltrated by cancer cells around the lesion, thereby improving the drug treatment intensity at the local cancer lesion, solving the problem of drug dosage, greatly reducing the drug cost, and solving the problem of high cost of cancer drug treatment.

[0096] (3) The setting of the convex flow guide strips and the concave flow guide grooves on the surface of the catheter causes the drug solution to flow in a spiral wrapping, curved oscillation, irregular micro-eddy current and micro-circulation mode in the drug administration space, thereby solving the problem of reduced drug solution concentration at the cancer lesion and the surrounding tissue infiltrated by cancer cells in the drug administration space, and changing the interaction between the drug solution and the cancer lesion from static to dynamic. The impact, interference, displacement and stripping of the drug solution on the cancer lesion and the surrounding tissue infiltrated by cancer cells improve the drug treatment effect.

[0097] (4) Pharmacokinetics shows that the drug treatment under dynamic interaction is more efficient and better than the drug treatment under static interaction.

[0098] (5) The active and controllable "discharge" design of the flow controller, which only needs one control valve to complete the adjustment of the flow pattern, distribution state, flow speed and residence time of the drug solution in the drug application space, greatly simplifies the treatment process and operation technology of the drug application catheter, and brings lower treatment cost;

[0099] (6) The self-guiding drug application catheter has simple structure, easy operation and low cost, and solves the problem of high cost of cancer treatment devices;

[0100] (7) The technical problems of flexible and controllable treatment scientific management and correct drug application for patients are solved.

[0101] Example 1

[0102] A self-guiding drug application catheter, comprising: a catheter body, which is a disposable medical consumable and is discarded after use; wherein the catheter body is a hollow catheter. In this embodiment, the length of the catheter body is 200-400 mm. The catheter body includes two different catheter bodies, a ball drug application catheter body and a balloon drug application catheter body. According to the test items and guidance of X-ray film, clinical diagnosis and catheter manual before the implementation of the drug application catheter treatment, the distance between the cancer lesion of the patient and the anus, the length of the rectum, and the length of the urethral orifice of the bladder to the penis or the urethral orifice of the urethra are determined, and the length of the catheter body inserted into the rectum or urethra is further determined. A length scale for cooperating with the flow controller is printed on the outer surface of the catheter body. The scale on the catheter indicates the length of the catheter head end that has entered the patient's natural cavity. The X-ray film, clinical diagnosis and catheter manual of the patient clearly indicate the distance from the rectal cancer lesion to the anus, the length of the rectum, and the distance from the urethral orifice of the bladder to the penis or the urethral orifice of the urethra. For example, the length of the rectum of Chinese people is 120-150 mm. The length of the urethra of Chinese men is 180-220 mm.

[0103] Example 2

[0104] This embodiment provides a use step and method of a drug application catheter for rectum (hereinafter referred to as rectal catheter, the structure is as shown in Figure 11

[0105] (1) Before using the rectal catheter, the patient completes defecation and enema cleaning of the rectum and sigmoid colon; clean rectum and sigmoid colon are an important guarantee for the treatment effect of the direct contact treatment method of the rectal catheter;

[0106] ​(2) Before the rectal catheter enters the rectum, first, according to the X-ray film, clinical diagnosis and catheter manual to determine the distance from the rectal cancer lesion to the anus and the length of the rectum of the patient; in this embodiment, first, determine the height, weight and gender of the patient; second, find the corresponding rectal length of the patient in the table in the catheter manual. The rectal length of Chinese men and women is 120-150 mm;

[0107] (3) Move the flow control controller and set the front end face of the flow control controller at the scale mark equal to the length of the rectum of the patient, and press the buckle of the sealing positioner tightly;

[0108] (4) Apply lubricating oil on the surface of the rectal catheter body in front of the flow control controller, on the surface of the catheter body in front of the air bag, and on the surface of the catheter body in front of the air bag;

[0109] (5) Rotate the rectal catheter along the curve direction of the convex flow guide bar and slowly insert it into the rectum of the patient until the front end face of the flow control controller hits the anus and cannot continue to insert. The head end of the flow control controller with a smaller diameter enters the anus of the patient, and the soft sealing gasket on the side curved surface of the circular table body tightly abuts against the skin surface around the anus and blocks the anus to prevent the drug from flowing out between the soft sealing gasket and the skin around the edge of the anus of the patient. In fact, when the flow control controller reaches the anus and cannot continue to insert, the air bag at the head end of the catheter has reached the junction of the rectum and the sigmoid colon;

[0110] (6) Hang the drug solution supply bag at a higher position, and the drug solution is in a state of entering the rectal catheter relying on natural gravity. Open the drug supply valve, and the drug solution enters the rectal catheter from the high position and enters the drug application space through the drug application holes on the surface of the front part of the rectal catheter. Place the drug recovery bag on the ground or at a position lower than the height of the rectal catheter, open the control valve, and the drug solution enters the drug recovery bag through the drug discharge pipe;

[0111] (7) Adjust the opening size of the control valve to control the residence time, flow speed, distribution state and change the flow mode of the drug solution in the drug application space;

[0112] Figure 11The figure shows the treatment process and working principle of the self-guiding rectal catheter. The figure shows a balloon rectal catheter entering the rectum 29 of the patient, and after the balloon 9 is inflated, the front end of the rectum 29 is blocked and a drug delivery space 14 is formed between the rectal catheter flow controller 4 and the rectum of the patient. The drug solution enters the inner cavity of the rectal catheter from the catheter connector 3 at the rear end of the rectal catheter, and then enters the drug delivery space 14 through the drug delivery hole 5 at the front of the rectal catheter. The figure shows the partial flow pattern of the drug solution in the drug delivery space 14, including the spiral flow pattern 16 along the curved shape of the convex flow guide strip 7 and the concave flow guide groove 6, the curved oscillation flow pattern 18 of the upper layer of drug solution, the micro-vortex and micro-circulation pattern 19 in the middle region of the drug delivery space, and the very thin laminar flow pattern 17 next to the natural cavity mucosa surface. The flow pattern between the micro-vortex and micro-circulation flow pattern 19 and the laminar flow on the natural cavity mucosa surface is the curved oscillation flow pattern 18.

[0113] (8) A standard drug solution supply bag with a capacity of 500 mL can provide a treatment dose for about 15-20 minutes. A drug solution supply bag with a capacity of 750 mL can provide a treatment dose for about 25-35 minutes.

[0114] (9) After the treatment is completed, the drug delivery valve is closed, and the rectal catheter is slowly withdrawn from the patient's rectum.

[0115] In the drug delivery space, a dynamic interaction occurs between the drug solution and the cancer lesion and the surrounding tissue infiltrated by cancer cells. Compared with the traditional static soaking treatment technology in medical catheters, the rectal catheter provided in this embodiment greatly improves the drug treatment intensity, treatment effect and treatment efficiency at the cancer lesion. In the traditional static soaking treatment technology, the drug solution is in a laminar flow distribution, and the mutual exchange of effective components in the drug solution is not strong, slow and low in efficiency. The dynamic interaction of the rectal catheter provided in this embodiment solves the core problem in the static treatment technology. The rectal catheter not only delivers the drug directly to the rectal cancer lesion, but also directly soaks the cancer lesion and the surrounding tissue infiltrated by cancer cells in the drug solution, and the drug solution directly contacts the cancer cells, killing the cancer cells in a dynamic interaction treatment technology, and can remove the killed cancer cells and small tissue fragments carrying the dead cancer cells from the diseased tissue in real time.

[0116] The advantages of the rectal catheter also include:

[0117] (1) For those patients who are diagnosed as advanced rectal cancer and cancer cells have metastasized to other organs, compared with chemotherapy and traditional drug treatment, rectal catheter bypasses the stomach and liver of cancer treatment drugs, and the original effective component of the drug is not lost, and the drug efficacy per unit area is greatly enhanced;

[0118] (2) The treatment time of rectal catheter does not affect the normal movement and life, which provides great convenience for the treatment time management, treatment location selection and treatment course arrangement of patients, so that the treatment of cancer can be timely processed and scientifically managed, and the time efficiency, treatment intensity and treatment effect of cancer treatment are greatly improved;

[0119] (3) The rectal surface mucosa and submucosa have rich microvessels, and the effective components in the drug are absorbed quickly; The original effective components in the cancer treatment drug penetrate the mucosa and submucosa of the rectum into the microvessels, and participate in the treatment of other metastatic cancers in the body through blood and general circulation.

[0120] Example 3

[0121] The present embodiment provides a use step and method of a prostate catheter in the treatment of prostate cancer:

[0122] (1) Before the prostate catheter enters the urethra, first, according to the X-ray film, clinical diagnosis book or catheter use manual to determine the distance from the patient's bladder urethral orifice to the external urethral orifice of the penis;

[0123] (2) Move the flow control controller, and set the vertex of the inner concave surface of the front end face disc of the flow control controller at the scale mark equal to the distance from the bladder urethral orifice to the external urethral orifice of the penis, and press the buckle;

[0124] (3) Apply lubricating oil on the surface of the prostate catheter in front of the flow control controller, the surface of the hollow elliptical ball, or the surface of the catheter body in front of the air bag;

[0125] (4) Rotate and slowly insert the prostate catheter into the patient's urethra along the convex flow guide bar curve direction until the vertex of the inner concave surface of the front end face disc of the flow control controller hits the external urethral orifice of the penis;

[0126] (5) The drug solution supply bag is hung at a higher position, and the drug solution is in a state of entering the prostatic duct by natural gravity. The drug valve is opened, and the drug solution enters the prostatic duct from the high position and enters the drug application space through the drug application holes on the front surface of the prostatic duct. The two vas deferens outlets of the prostate are located in the closed space. In the closed space, part of the drug enters the vas deferens and penetrates into the middle lobe of the prostate through the mucosa layer, muscle layer and adventitia layer of the vas deferens. Part of the drug penetrates into the anterior lobe, left lobe, right lobe and middle lobe of the prostate after entering the prostate capsule through the mucosa layer, submucosa layer and muscle layer of the urethra. The drug solution recovery bag is placed on the ground or at a position lower than the height of the prostatic duct, and the control valve is opened. The drug solution enters the drug solution recovery bag through the drug discharge pipe;

[0127] (6) The opening size of the control valve is adjusted to control the residence time, flow speed, distribution state and flow mode of the drug solution in the drug application space;

[0128] (7) A standard drug solution supply bag with a capacity of 500 mL can provide a treatment dose for about 30-40 minutes. A drug solution supply bag with a capacity of 750 mL can provide a treatment dose for about 45-60 minutes;

[0129] (8) After the treatment is completed, the drug valve is closed, and the prostatic duct is slowly pulled out of the urethra of the patient.

[0130] As a preferred embodiment, for patients with prostate cancer, the treatment effect of simultaneously using a prostatic duct and a rectal duct is better than that of using only a prostatic duct. In the drug application space established by the rectal duct in the rectum of the patient, the cancer treatment drug penetrates into the posterior lobe, left lobe and right lobe of the prostate through the mucosa layer, submucosa layer, muscle layer and serosa layer of the rectum, and then enters the middle lobe. In the drug application space established by the prostatic duct, part of the drug enters the middle lobe of the prostate through the two vas deferens, and part of the drug penetrates into the anterior lobe, left lobe and right lobe of the prostate through the mucosa layer, submucosa layer and muscle layer of the urethra, and then enters the middle lobe. The joint treatment of the prostatic duct and the rectal duct can make more drugs simultaneously perform a full-directional targeted treatment on the prostate cancer.

[0131] As a preferred embodiment, the calculation of the drug dosage includes: calculating the precise dosage of the chemotherapy drug according to the patient's body surface area formula. The body surface area is calculated based on the patient's gender, weight and height. Therefore, the use of chemotherapy drugs and the distribution of drugs in the patient's body are affected by weight. The drug delivery catheter is a targeted local drug delivery and treatment device that can directly immerse the cancer cells on the inner surface of the natural cavity or organ of the patient in the cancer treatment liquid, which is a direct contact treatment method. According to the catheter calculation of the body surface area, only part of the natural cavity and the inner surface area (weight) of the organ including the cancer lesion is included, which is relatively smaller than the patient's body surface area (body weight) by tens or even hundreds of times. Therefore, the targeted local drug delivery method and the direct contact treatment method of the drug delivery catheter make the drug dosage of the drug delivery catheter tens or even hundreds of times smaller than the traditional chemotherapy systemic drug dosage. As a widely used main means of cancer treatment in clinical practice, chemotherapy has good treatment effect on systemic high sensitivity cancer (such as leukemia and lymphoma), but there are still some limitations in the treatment of medium sensitivity cancer (such as rectal cancer, prostate cancer and bladder cancer), including (but not limited to): first, the chemotherapy drug is administered to the whole body of the patient, not targeted drug delivery, so the drug dosage is relatively large. Second, the chemotherapy drug kills a large number of normal cells while killing cancer cells, which is one of the reasons why patients suffer great pain and strong side effects after chemotherapy. Third, the systemic administration of chemotherapy is a "rain and dew" method, which cannot concentrate the drug efficacy on the cancer lesion and the tissue around the lesion infiltrated by cancer cells for high-intensity and high-dose treatment.

[0132] The target local administration path, direct contact and dynamic interaction of the administration catheter are different from the traditional chemotherapy drugs and treatment methods. The advantages of the self-guiding administration catheter provided in the present application include, but are not limited to: first, compared with the systemic administration of traditional chemotherapy drugs, the administration catheter can be precisely administered locally at the cancer lesion, greatly reducing the dosage of the drug. Second, the original effective components in the drug are not destroyed and wasted by biochemical reactions such as gastric acid, digestive enzymes and liver first-pass effect, greatly maintaining the original effective components and therapeutic efficacy of the drug. Third, compared with the systemic administration of traditional chemotherapy drugs, the target local administration of the administration catheter greatly reduces the dosage of the drug, but the drug action intensity per unit area (weight) at the cancer lesion is increased by tens or even hundreds of times compared with the traditional administration method. Fourth, the convex flow guide strip and concave flow guide groove technology on the surface of the administration catheter creates different flow patterns of multiple drug solutions in the administration space, including spiral circumferential flow pattern, curved oscillation flow pattern, micro-vortex and micro-circulation flow pattern in a local range, greatly improving the treatment efficiency and effect of the drug solution on cancer cells. Fifth, the administration catheter can be used without affecting the patient's eating, excretion and normal rest, greatly improving the patient's treatment, living environment and quality of life, making the treatment process more humanized. Sixth, compared with the traditional complex treatment process, the administration catheter is more flexible, convenient, reasonable and efficient, and the administration time, treatment cycle and entire treatment process can be managed by computer information, automation and scientific management. Seventh, the administration catheter has the characteristics of simple operation, convenient use and low cost, and can be widely used in various hospitals and can be operated by patients in emergency situations.

[0133] As a preferred embodiment, according to the description and application of the rectal catheter and the prostate catheter, the administration catheter can derive a bladder catheter, a bronchial catheter, an esophageal catheter, a ureter and renal catheter, a uterine catheter, a pancreatic biliary duct catheter, a lacrimal gland catheter, a bone cavity bone marrow catheter, an ear nose and throat catheter, a gastric catheter and a colon catheter. All the above derived administration catheters can be used for bladder cancer administration, bronchial cancer administration, esophageal cancer administration, ureter and renal cancer administration, cervical cancer administration, endometrial cancer administration, ovarian cancer administration, pancreatic biliary duct cancer administration, lacrimal gland administration, bone cavity bone marrow cancer administration, ear nose and throat cancer administration, gastric cancer administration, colon cancer administration, and any kind of cancer that can be treated by catheter administration in the natural cavity and organs of the human body.

[0134] While the preferred embodiments of the application have been described, additional variations and modifications can be made to these embodiments by those skilled in the art once they have the benefit of the foregoing description without departing from the spirit and scope of the application. Accordingly, it is intended that the appended claims be interpreted as including all such variations and modifications as fall within the spirit and scope of the application. It is further intended that the disclosure of all such modifications and variations be included within the scope of the application, the terms used herein being defined solely for purposes of the description being applied thereto unless otherwise indicated.

Claims

1. A self-guiding drug delivery catheter, comprising a hollow catheter body, a front closure member provided at the front of the catheter body, a drug delivery hole provided on the catheter body near the rear of the front closure member, and a catheter connector provided at the rear end of the catheter body, characterized in that: The self-guiding medication administration catheter further includes a flow diversion controller, which is composed of a truncated cone with an inwardly concave side surface or a disc with an outwardly convex side surface, a connecting pipe, a sealing positioner, a discharge pipe, and a control valve; the diameter of the central through hole of the truncated cone or disc is equal to the inner diameter of the connecting pipe and larger than the diameter of the outer surface of the catheter body; The front end of the connecting pipe is located at the rear end of the frustum or disc, a drug discharge hole is provided on the connecting pipe, the front end of the discharge pipe is connected to the drug discharge hole, and the rear end of the discharge pipe is provided with the control valve; The sealing locator comprises an upper and a lower semicircular tubes, one end of the two semicircular tubes being movably connected to the rear portion of the connecting tube, and the other end of the two semicircular tubes being provided with a buckle having two states of locking and releasing. A soft sealing sheet is provided on the inner wall of each of the two semicircular tubes, the inner surface diameter of the soft sealing sheet being smaller than the outer surface diameter of the catheter body, and the thickness of the soft sealing sheet being greater than the gap between the inner surface of the connecting tube and the outer surface of the catheter body; when the buckle is in the locked state, the two semicircular tubes are combined into one, and the soft sealing sheet closes the gap between the inner surface of the connecting tube and the outer surface of the catheter body at the rear end of the connecting tube, while fixing the position of the flow guide controller on the catheter body; when the buckle is in the released state, the two semicircular tubes are released, and the flow guide controller can move forward and backward axially along the outer circumferential surface of the catheter body; the front sealing member, the flow guide controller, the outer surface of the catheter body and the inner surface of the patient's natural cavity together form a drug application space in the patient's body; Convex guide strips and concave guide grooves are alternately arranged on the outer surface of the conduit body. There are a plurality of convex guide strips and a plurality of concave guide grooves, each of which is curved and independent of each other.

2. The self-guiding drug administration catheter according to claim 1, characterized in that: When liquid medicine is injected into the catheter body, the liquid medicine enters the drug application space from the drug administration hole and flows toward the rear end of the catheter body. Under the action of the convex guide strips and the concave guide grooves, the liquid medicine forms a flow pattern including spiral flow, curved oscillating flow, micro-vortex flow and micro-circulation flow; the guide controller changes the flow pattern, distribution state, flow speed and residence time of the liquid medicine in the drug application space through the control valve, thereby realizing the conversion of the catheter between static treatment and dynamic interactive treatment modes.

3. The self-guiding drug administration catheter according to claim 1 or 2, characterized in that: When the catheter body is a rectal catheter, the front portion of the flow diversion controller is shaped like a truncated cone with a rotating curved surface whose side surface is concave inward, and the small end of the truncated cone is the front end of the truncated cone, facing the front end of the rectal catheter; a soft sealing gasket is provided on the side surface of the truncated cone; When the catheter body is a prostate catheter, the front shape of the flow diversion controller is a circular disc with a rotating curved surface whose side surface is convex outward, and the front end opening of the circular disc faces the front end of the prostate catheter; a soft sealing gasket is provided on the inner surface of the circular disc.

4. The self-guiding drug administration catheter according to claim 1 or 2, characterized in that: One end of the two semicircular tubes is connected to a pair of hinges arranged at the rear part of the connecting tube.

5. The self-guiding drug administration catheter according to claim 1 or 2, characterized in that: The front sealing member is an airbag located on the front outer surface of the catheter body. A small portion of the catheter body is located in front of the airbag, and an arc-shaped cap is provided on the head end of the catheter body in front of the airbag to seal the head end. A branch catheter is provided at the rear of the catheter body. A thin catheter is provided in the inner cavity of the branch catheter and the catheter body, and the thin catheter is connected to the airbag. By injecting water or air into the thin catheter, the airbag is inflated and the front end of the drug application space is sealed. A plurality of drug delivery holes are located on the catheter body behind the airbag; or, The front sealing member is a hollow ellipsoid located at the front end of the catheter body; the long axis of the hollow ellipsoid coincides with the center line of the catheter body, and the short axis is larger than the outer diameter of the catheter body; the multiple drug delivery holes are located on the catheter body near the hollow ellipsoid.

6. The self-guiding drug administration catheter according to claim 1 or 2, characterized in that: The curve shapes of each of the convex guide strips and the concave guide grooves are the same or different.

7. The self-guiding drug administration catheter according to claim 6, wherein: A plurality of the convex guide strips are distributed in the front area of ​​the duct body; A plurality of the concave guide grooves are distributed in the front and middle areas of the conduit body; In the front area of ​​the conduit body, a convex guide strip and a concave guide groove are alternately arranged, and the front end is the convex guide strip.

8. The self-guiding drug administration catheter according to claim 7, characterized in that: The curve length of each of the convex guide strips and the concave guide grooves is less than four times the diameter of the conduit body; When the catheter body is a rectal catheter, the height of the convex guide strip is less than 10 mm, and the angle between the projection of a tangent line at any point on the central curve of the convex guide strip and the tail end portion of the concave guide groove on a plane that coincides with the central axis of the catheter body and is perpendicular to the radial direction of the point and the central axis of the medication catheter body is less than 180°; When the catheter body is a prostate catheter, the height of the convex guide strip is less than 2 mm, and the angle between the projection of the tangent of any point on the central curve of the convex guide strip and the tail end of the concave guide groove on a plane coinciding with the central axis of the catheter body and perpendicular to the radial direction of the point and the central axis of the medication catheter body is less than 120°.

9. A pesticide application system, characterized in that: It comprises a drug liquid supply bag, a drug delivery tube, a drug liquid recovery bag, a drug discharge tube and the self-guiding drug delivery catheter according to any one of claims 1 to 8; One end of the drug delivery tube is connected to the drug liquid supply bag, and the other end is connected to the catheter connector at the rear end of the catheter body; a drug delivery valve is provided on the drug delivery tube; One end of the medicine discharge pipe is connected to the medicine liquid recovery bag, and the other end is connected to the control valve at the rear end of the discharge pipe in the diversion controller.

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