CN115501459B

CN115501459B - Catheter

Info

Publication number: CN115501459B
Application number: CN202211180547.5A
Authority: CN
Inventors: 刘朝生; 李琴芳; 韦政军; 林浩; 张志旋; 郭新宇; 周友明
Original assignee: Guangdong Bomai Medical Technology Co Ltd
Current assignee: Guangdong Bomai Medical Technology Co Ltd
Priority date: 2022-09-27
Filing date: 2022-09-27
Publication date: 2023-08-18
Anticipated expiration: 2042-09-27
Also published as: CN115501459A

Abstract

The application belongs to the field of medical instruments, and particularly relates to a catheter and a drug delivery method. The catheter includes: a drug storage body made of degradable material and containing drug; a first bladder made of an elastic material and having an expanded state and a contracted state; when the first bag body is in a contracted state, the outer surface of the first bag body contracts and clamps the medicine storage body; the first bag body is connected to the insertion end, and the pipe body component is provided with a first flow passage; the first flow channel is used for inputting medium into the first bag body so as to enable the first bag body to be switched to an expanded state; the first bag body is unfolded on the outer surface of the first bag body in an expanded state, can release the medicine storage body to the focus area and presses the medicine storage body to abut against human organs of the focus area. The catheter assembly provided by the application can reduce drug loss.

Description

Catheter

Technical Field

The application belongs to the field of medical instruments, and particularly relates to a catheter and a drug delivery method.

Background

Balloon dilation catheter is an interventional medical device, mainly comprising a balloon and a tube body assembly, and is often matched with a guide wire to treat vascular diseases; the balloon after the intervention of the blood vessel is inflated and expanded, so that the blocked blood vessel can be dredged. In addition, the balloon dilation catheter can also carry medicines to carry out medicine treatment on the lesion part; specifically, a drug coating is generally coated on the outer surface of the balloon, and after the balloon dilation catheter is inserted into a blood vessel, the drug is released to a lesion site by a proper mode; the blood vessel can be physically dredged and simultaneously treated by the medicine. Compared with the treatment mode of implanting the stent, the side effect of the operation can be reduced by using the balloon dilation catheter and treating the stent in the mode, so that the balloon dilation catheter and the drug coating balloon catheter are widely applied.

However, the drug is directly coated on the outer surface of the balloon, and is easily washed by blood flow and is largely lost in the process of being transported into the blood vessel through the balloon and the subsequent release process, so that the treatment effect is affected.

Disclosure of Invention

The embodiment of the application aims to provide a catheter and a drug delivery method, which aim to solve the problem of how to reduce drug loss.

In order to achieve the above purpose, the application adopts the following technical scheme:

in one aspect, a catheter for delivering a drug to a focal zone is provided, the catheter comprising:

a drug storage body made of degradable material and containing the drug;

a first bladder made of an elastic material and having an expanded state and a contracted state; when the first bag body is in the contracted state, the outer surface of the first bag body contracts and clamps the medicine storage body;

the first sac body is connected to the insertion end, and the first flow passage is formed in the pipe body assembly; the first flow passage is used for inputting medium to the first bag body so as to enable the first bag body to be switched to the expansion state;

the first bag body is unfolded on the outer surface of the first bag body in an expanded state, can release the medicine storage body to the focus area and presses the medicine storage body to abut against human organs of the focus area.

Optionally, in some embodiments, the drug storage body is made of a memory material and has a rolled state and a deployed state, the drug storage body being heated to switch from the rolled state to the deployed state; when the medicine storage body is in the curled state, the medicine is wrapped and contained; when the medicine storage body is in the unfolding state, the medicine storage body is provided with an opening, and the medicine is released from the opening.

Optionally, in some embodiments, the drug storage body is configured in a hemispherical or bowl shape in the deployed state.

Optionally, in some embodiments, the opening is provided with a plurality of saw teeth, and each saw tooth can be inserted into an organ of the human body in the focal zone.

Optionally, in some embodiments, magnetic particles are disposed in the drug storage body, and the drug storage body acts on the focal zone under the action of an external magnetic field.

Optionally, in some embodiments, an outer surface of the first capsule is provided with an adhesive layer, the adhesive layer adhering to the drug storage body.

Optionally, in some embodiments, the catheter further comprises a second balloon connected to the insertion end and capable of elastic expansion, the tube assembly further having a second flow channel in communication with the second balloon, the second flow channel capable of inputting a medium to the second balloon to expand the second balloon and abut the human organ to obstruct blood flow between the first balloon and the second balloon.

Optionally, in some embodiments, the tube assembly comprises a first tube and a second tube; the second pipe body is sleeved outside the first pipe body, and the first flow passage is formed between the second pipe body and the first pipe body.

Optionally, in some embodiments, the tube assembly further has a plenum end disposed away from the insertion end, the plenum end being capable of inputting a medium to the first flow passage to switch the first bladder to the expanded state, an end of the insertion end being tapered in cross-sectional area in a direction away from the plenum end.

In another aspect, there is also provided a method of drug delivery, carried out using said catheter, said method of drug delivery comprising the steps of:

inserting, wherein the insertion end extends into the focus area;

pressurizing, namely inputting a medium into the first runner to enable the first bag body to be switched to the expansion state, and pressing the medicine storage body to be abutted against the human viscera of the focus area; and

and the medicine storage body is connected with the viscera of the human body in the focus area and releases the medicine to the focus area.

The application has the beneficial effects that: the insertion end extends into the focus area, and the first bag body holding the medicine storage body and the human organ of the focus area are arranged oppositely; pressurizing the first bag body through the first runner so as to switch the first bag body to an expanded state; meanwhile, the first bag body gradually releases the medicine storage body on the outer surface of the first bag body, and pushes the medicine storage body to the human viscera of the focus area, so that the medicine storage body can be connected with the human viscera and release medicine to the human viscera of the focus area in a mode of unfolding and/or self-degradation and the like. The first bag body gradually compresses the medicine storage body between the human viscera and the outer wall of the first bag body in the expansion process, and then the first bag body continues to expand so that the part of the outer surface of the first bag body, which is not provided with the medicine storage body, is attached to the human viscera, and the blood flow of the first bag body is limited; and in the process of releasing the medicine from the medicine storage body, the medicine storage body is tightly connected with the viscera of the human body in the focus area, thereby being beneficial to preventing the medicine from being washed by blood. In conclusion, the application solves the technical problem of how to reduce the drug loss.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments or exemplary technical descriptions will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained according to these drawings without inventive effort for a person of ordinary skill in the art.

FIG. 1 is a schematic illustration of a catheter according to an embodiment of the present application;

FIG. 2 is a cross-sectional view of the catheter of FIG. 1 taken in the direction A;

FIG. 3 is a cross-sectional view of the catheter of FIG. 1 in the direction B;

FIG. 4 is a schematic view of a first bladder according to an embodiment of the present application in a contracted state;

FIG. 5 is a schematic view of a first bladder according to another embodiment of the present application in a contracted state;

FIG. 6 is a schematic structural view of a drug storage body in an unfolded state according to an embodiment of the present application;

FIG. 7 is a schematic view of the catheter of FIG. 1 in a contracted state with both the first balloon and the second balloon;

FIG. 8 is a schematic illustration of the relative positions of a drug, a tissue wall, a drug reservoir and a first balloon at the catheter access focal zone of FIG. 1 with the first balloon in a contracted state;

FIG. 9 is a schematic view of the catheter of FIG. 1 with both the first balloon and the second balloon in an inflated state and abutting the tissue wall;

FIG. 10 is a schematic illustration of the relative positions of the drug, tissue walls, drug reservoir and first balloon of the catheter of FIG. 1 with the first balloon in an inflated state and the drug reservoir contacting the lesion;

FIG. 11 is a schematic illustration of the relative positions of the drug, tissue walls, drug reservoir and first balloon of the catheter of FIG. 1 when the first balloon is in an inflated state and the drug reservoir is deployed and connected to a lesion;

FIG. 12 is a schematic illustration of the relative positions of the drug, tissue walls, drug reservoir and first balloon of the catheter of FIG. 1 in an inflated state with the drug reservoir attached to the lesion and releasing the drug;

FIG. 13 is a schematic view of the relative positions of the drug, tissue walls, drug reservoir and first balloon of the catheter of FIG. 1 when the first balloon is in a contracted state and the drug reservoir is disengaged from the first balloon and connected to the lesion.

Wherein, each reference sign in the figure: 100. a conduit; 10. a tube assembly; 11. an insertion end; 12. a pressurizing end; 13. a first tube body; 131. a guidewire lumen; 132. a guide wire port; 133. developing the mark; 14. a second tube body; 15. a first flow passage; 151. a first pressurizing port; 16. a second flow passage; 161. a second pressurizing port; 20. a first bladder; 21. an adhesive layer; 22. a fish tail shaped groove; 23. a flap; 24. a gap; 30. a second bladder; 40. a drug storage body; 41. saw teeth; 42. an opening; 50. a drug; 60. tissue or organ; 61. a tissue wall; 62. focal zone.

Detailed Description

The present application will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present application more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application.

It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", etc. are based on the orientation or positional relationship shown in the drawings, are for convenience of description only, and are not intended to indicate or imply that the apparatus or element in question must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the application, and the specific meaning of the terms described above will be understood by those of ordinary skill in the art as appropriate. The terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "a plurality of" is two or more, unless specifically defined otherwise.

Referring to fig. 1, 3 and 8, a catheter 100 for delivering a drug 50 to a focal zone 62 is provided in accordance with an embodiment of the present application. Catheter 100 includes drug storage body 40, first balloon and tube assembly 10. Wherein the drug storage body 40 is made of a degradable material and accommodates the drug 50. The first bladder 20 is made of an elastic material and has an expanded state and a contracted state; and when the first bladder 20 is in the contracted state, the outer surface of the first bladder 20 contracts and holds the medicine storage body 40. The tube assembly 10 is provided with an insertion end 11 for being inserted into the focal zone 62, the first bag body 20 is connected to the insertion end 11, and the tube assembly 10 is provided with a first flow passage 15; the first flow passage 15 is used to input a medium to the first bladder 20 to switch the first bladder 20 to the inflated state. Further, the first balloon 20 is in an inflated state, and its outer surface is deployed and will release the drug-storing body 40 at the focal zone 62, and press the drug-storing body 40 against the organs of the human body at the focal zone 62. Referring to FIG. 8, in some embodiments, the focal zone 62 may be located on an inner wall of a tissue or organ 60, such as a blood vessel, of a human body, which may be a blood vessel.

The drug storage body 40 is made of a degradable material. Specifically, the drug reservoir 40 may be made of a biodegradable material that is capable of being absorbed down the organism to release the drug 50 to the corresponding location of the focal zone 62. Alternatively, the drug reservoir 40 is made of one or more of polylactic acid-based polymer, polyolefin polymer, and polyester material. It will be appreciated that after the drug storage body 40 is delivered to the focal zone 62 via the first balloon 20, the drug storage body is released when the first balloon 20 is switched to the inflated state, and is further capable of being connected to the organs of the human body at the focal zone 62, and gradually degrading to release the drug 50 stored therein to the site. In addition, since the medicine storage body 40 is biodegradable, no great toxic or side effects are brought about.

The drug 50 may be a lipid-soluble drug 50. Optionally, the drug 50 is one or more of an anticancer drug, an anticoagulant, and a microbial immunosuppressant. Optionally, the drug 50 is one or more of paclitaxel or liposoluble drugs such as rapamycin, sirolimus, etc.

In the contracted state, the first bladder 20 has folds or grooves formed on its surface; the medicine storage bodies 40 may be provided in plurality, wherein a part of the medicine storage bodies 40 can be accommodated in the folds or the grooves, and another part of the medicine storage bodies 40 can be adhered to other parts of the outer surface of the first bag body 20. Referring to fig. 3, the first bladder 20 is in an inflated state with the pleats or grooves stretched and the medicine storage body 40 stored therein is discharged; after the first bladder 20 expands and has a smoother outer surface, each drug storage body 40 is completely exposed and can be pressed by the outer surface of the first bladder 20 to the corresponding part of the viscera of the human body in the focal zone 62, thereby releasing the drug 50 thereto.

The tube assembly 10 may be integrally formed or may comprise a plurality of components and together comprise an assembly having a first flow passage 15. Wherein, the first runner 15 is communicated with the inside of the first bag body 20 and the external pressurizing structure at the same time; the external pressurizing structure is capable of delivering medium to the first bladder 20 through the first flow passage 15; the medium may be a gas, a liquid, or other fluid capable of switching the first bladder 20 from the contracted state to the expanded state.

It will be appreciated that the insertion end 11 is extended into the focal zone 62, and the first balloon 20 holding the drug storage body 40 is disposed opposite to the human organ of the focal zone 62; pressurizing the first bladder 20 through the first flow passage 15 to switch the first bladder 20 to the inflated state; at the same time, the first capsule 20 gradually releases the drug storage body 40 on the outer surface thereof, and pushes the drug storage body 40 to the human organ of the focal zone 62, so that the drug storage body 40 can be connected with the human organ and release the drug 50 to the human organ of the focal zone 62 by means of unfolding and/or self-degradation. Wherein, the first bag body 20 gradually compresses the medicine storage body 40 between the viscera and the outer wall thereof in the expansion process, and then continues to expand so that the part of the outer surface of the medicine storage body 40 which is not provided with the medicine storage body is attached to the viscera, thereby restricting the blood flow; and during the process of releasing the drug 50 from the drug reservoir 40, it is tightly connected to the organs of the human body in the focal zone 62, thereby helping to prevent the drug 50 from being washed by blood. In summary, the present application solves the technical problem of how to reduce the loss of the drug 50.

In addition, since the loss of the medicine 50 is small and the utilization rate of the medicine 50 is high, the medicine 50 carried by the first capsule body 20 is small when the medicine is used for treatment, thereby being beneficial to reducing the production cost; and also helps to reduce toxicity of the drug 50 to the human system due to the reduced amount of drug 50 flowing to other parts of the human body.

Optionally, the drug 50 is externally provided with a coating; the coating layer can be liposome, hydrogel, micelle, vesicle or degradable macromolecule; the medicine 50 is wrapped by the wrapping layer and then stored in the medicine storage body 40. It can be appreciated that the wrapping layer has a strong viscosity, and the drug 50 can be adhered to the corresponding part of the viscera of the human body through the wrapping layer located outside the drug storage body 40 after being released, so as to avoid the loss of the drug 50 due to blood washing. Wherein the degradable polymer can be poly (lactic acid-co-glycolic acid), polylactic acid, poly epsilon-caprolactone, collagen, albumin, gelatin, chitosan, etc.

Referring to fig. 4, optionally, in some embodiments, the first bladder 20 may have a fishtail groove 22 formed in its surface when in the contracted state; the notches of the fish tail shaped groove 22 can be closed, and a narrow space can be opened to enable the medicine storage body 40 to be stored in the groove. Optionally, the fishtail groove 22 is formed in plurality when the first bladder 20 is in the contracted state; a plurality of medicine storage bodies 40 are accommodated in any one of the fishtail grooves 22. It will be appreciated that each of the fishtail grooves 22 is capable of expanding and forming a smoother surface when the first bladder 20 is in the inflated condition and exposing each of the reservoirs 40 to connect with the body organ of the focal zone 62.

Referring to fig. 5, optionally, in some embodiments, the first bladder 20 is formed with a flap 23 on a surface thereof when in a contracted state; each of the flaps 23 may be spirally arranged in the same direction, and a gap 24 capable of accommodating the medicine storage body 40 is formed between two adjacent flaps 23; when the first bladder 20 is switched to the inflated state, the gaps 24 between the flaps 23 disappear and will expose the drug storage body 40 therein to connect with the body organs of the focal zone 62.

Alternatively, in some embodiments, the drug storage body 40 is made of a memory material and has a rolled state and an unfolded state, and the drug storage body 40 is heated to switch from the rolled state to the unfolded state. In fig. 8 and 10, the medicine storage body 40 is in a curled state; when the medicine storage body 40 is in a curled state, the medicine 50 is wrapped and contained. In fig. 6 and 11 to 13, the medicine storage body 40 is in a deployed state; when the drug storage body 40 is in the deployed state, the drug storage body 40 has an opening 42, and the drug 50 is released from the opening 42. It will be appreciated that in these embodiments, the drug reservoir 40 is in a coiled state prior to heating and is capable of enclosing the drug 50 to prevent the drug 50 from escaping under the scouring action of blood; the medicine storage body 40 is switched to the unfolding state after being heated, and is connected with the human viscera at the opening 42 and releases the medicine 50 at the opening 42, so that the medicine 50 can be directionally released to the corresponding part of the human viscera after flowing out through the opening 42, and further the loss caused by the medicine 50 flowing to the other directions is avoided.

Alternatively, the drug reservoir 40 is made of a high molecular polymer material having a shape memory effect. Specifically, the drug reservoir 40 may be made of one or more of polylactic acid-based polymers, polyolefin polymers, and polyurethane polymers, polyethylene, polyisoprene, polyester, and polyamide-based materials. It can be understood that the material integrates good biodegradability, biocompatibility and shape memory, basically has very good high mechanical strength and flexibility, and the deformation temperature can be adjusted to be near the temperature of a human body; therefore, the device is suitable for surgical operation or medical instrument intervention body, is easy to be deformed to a unfolding state by heating to release the medicine 50, and is not easy to generate repulsive action with human body. Alternatively, the drug reservoir 40 is made of one or more materials of high trans-polyisoprene, polynorbornene, polyurethane, and styrene-butadiene copolymer.

It will be appreciated that the drug reservoir 40 is made of a material having shape memory; shape memory is a temperature-dependent property that enables a shape memory material to deform at a temperature and then recover its original, undeformed shape when heated above a "deformation temperature". For example, the deformation temperature of the high trans polyisoprene material is 50 to 60 degrees, and the drug reservoir 40 made thereof expands and releases the drug 50 at 50 to 60 degrees. It will be appreciated that the foregoing material has a shape memory effect because it has a reversible phase that can undergo a "soft-hard" transition under external field stimulation, and thus can deform and set. The "soft-hard" transition of the reversible phase is achieved by a phase transition of the polymer, such as a transition from crystalline to molten or from glassy to highly elastic, etc., the transition temperatures being the crystalline melting temperature and the glass transition temperature, respectively. The stationary phase is formed by chemical crosslinking or physical crosslinking of high molecular chains, and can prevent molecular sliding and stress relaxation, thereby helping deformation and stress freezing and memorization.

Alternatively, the drug reservoir 40 is made of a degradable high molecular polymer material having a shape memory effect. The drug 50 is slowly released after the drug storage body 40 is unfolded, and the drug storage body 40 is degraded in the organism after the drug 50 is released, so that no toxic or side effect is generated.

It will be appreciated that the drug storage body 40 may be switched to the deployed state and release the drug 50 by one or more of the following means: hot water or hot air having a proper temperature is injected into the first bladder 20 through the first flow passage 15; heating the drug reservoir 40 by body temperature; energizing the drug storage body 40; applying radio frequency or X-ray energy to the drug storage body 40 by a suitable means; introducing a light source into the tube assembly 10 and causing the light source to illuminate the drug storage body 40 to cause it to expand; the magnetic field is used to heat the drug reservoir 40.

Referring to fig. 8 and 10, in some embodiments, the medicine storage body 40 is optionally configured in a shape of a closed body such as a steamed stuffed bun or a sphere when in a curled state. It will be appreciated that in these embodiments, the medicament 50 can be wrapped around and enclosed within the steamed stuffed bun or ball 40 to avoid loss from blood washout.

Referring to fig. 6, 11-13, optionally, in some embodiments, the drug storage body 40 is configured in a hemispherical or bowl shape in the unfolded state. It will be appreciated that in this embodiment, an opening 42 having a larger cross-sectional area may be formed at the circular cross-section of the hemispherical or bowl-shaped medicine storage body 40; on the one hand, the medicine storage body 40 is connected with the viscera of the human body in the focus area 62 in a stable way, so that the medicine 50 is prevented from being lost; on the other hand, it also helps to increase the flow rate of the medicament 50 per unit time through the larger opening 42 to increase the speed of delivery of the medicament 50.

Referring to fig. 6, in some embodiments, a plurality of saw teeth 41 are disposed at the opening 42, and each saw tooth 41 can be inserted into a human organ of the focal zone 62. It can be appreciated that each serration 41 is exposed in the unfolded state of the medicine storage body 40 and can be inserted into a corresponding portion of the human viscera, so that the medicine storage body 40 is stably connected to the human viscera and is not easy to fall off or generate gaps locally, thereby helping to reduce the loss of the medicine 50.

Optionally, in some embodiments, magnetic particles are disposed within the drug reservoir 40, and the drug reservoir 40 acts upon the focal zone 62 under the influence of an external magnetic field. It will be appreciated that in these embodiments, the drug reservoir 40 may be more tightly embedded in the focal zone 62 without becoming dislodged by the application of an externally applied magnetic field, thereby helping to reduce drug 50 loss.

Referring to fig. 3, optionally, in some embodiments, an adhesive layer 21 is provided on an outer surface of the first bladder 20, and the adhesive layer 21 adheres to the drug storage body 40. It will be appreciated that in these embodiments, when the first bladder 20 is in the contracted state, a portion of the drug storage body 40 can be stored in the folds or grooves formed on the outer surface of the first bladder 20 and stably connected to the corresponding portion of the outer surface of the first bladder 20 by the adhesive layer 21; the other part may be directly adhered to the outer surface of the first bladder 20 by the adhesive layer 21. Thus, these embodiments help to stabilize the first bladder 20 in connection with the drug storage body 40 to prevent the drug storage body 40 from falling out during delivery of the catheter 100, thereby helping to reduce or avoid loss of the drug 50. Alternatively, in some embodiments, the adhesive layer 21 is a coating sprayed onto the surface of the first bladder 20. It will be appreciated that the adhesive layer 21 is applied to the surface of the first bladder 20 and is not released to the organs of the human body in the focal zone 62 along with the drug storage body 40, thereby helping to reduce or avoid toxic and side effects caused by the material of the coating entering the blood.

Referring to fig. 1, 7 and 9, optionally, in some embodiments, the catheter 100 further includes a second balloon 30 connected to the insertion end 11 and capable of being elastically expanded, the tube assembly 10 further has a second flow channel 16 communicating with the second balloon 30, and the second flow channel 16 is capable of inputting a medium into the second balloon 30 to expand the second balloon 30 and abut against the human organ to obstruct blood flow between the first balloon 20 and the second balloon 30. In fig. 1 and 9, the first bladder 20 and the second bladder 30 are both in an inflated state; in fig. 7, both the first bladder 20 and the second bladder 30 are in a contracted state. It will be appreciated that the second balloon 30 can be inserted into the focal zone 62 with the first balloon 20 for use with the first balloon 20; specifically, the second balloon 30 is inflated and abuts against the corresponding portion of the human organ and restricts the flow of blood or other body fluid between the first balloon 20, thereby preventing the first balloon 20 from being washed out and causing the loss of the drug 50 when the drug storage body 40 is released. Wherein the second bladder 30 may be inflated prior to the first bladder 20. Optionally, the second balloon 30 is positioned at the forward end of the insertion end 11 in the direction of insertion. Optionally, focal zone 62 is located on the inner wall of tissue or organ 60, such as a human blood vessel; it will be appreciated that the insertion end 11 is capable of extending into a tissue or organ 60 such as a blood vessel and positioning the first balloon 20 opposite the focal zone 62; pressurizing the second bladder 30 through the second flow channel 16 to expand the second bladder 30 and abut against a circumference of an inner wall of a tissue or organ 60 such as a blood vessel to obstruct blood flow therein, and pressurizing the first bladder 20 through the first flow channel 15 to switch the first bladder 20 to an expanded state and release the drug storage body 40 held on an outer surface thereof, and pressing the drug storage body 40 between the outer surface thereof and the tissue wall 61 of the focal zone 62; drug 50 may be released to the corresponding location of focal zone 62 by appropriate means to deploy or degrade drug reservoir 40.

Referring to fig. 1-3, optionally, in some embodiments, the tube assembly 10 includes a first tube 13 and a second tube 14; the second pipe body 14 is sleeved outside the first pipe body 13, and a first flow passage 15 is formed between the second pipe body and the first pipe body 13. It can be appreciated that the first pipe body 13 and the second pipe body 14 can be integrally formed, or can be assembled to form the pipe body assembly 10 after being respectively processed; wherein, the first tube body 13 and the second tube body 14 are made of flexible materials and can be inserted into human body parts with narrow channels such as blood vessels, fallopian tubes, alimentary tracts and the like; the first tube 13 has a smaller cross-sectional area and is capable of allowing the second tube 14 having a larger cross-sectional area to be sleeved outside thereof to form the first flow passage 15. It will be appreciated that the first fluid passage 15 can be used to communicate the first bladder 20 with an external pressurizing structure to pressurize the first bladder 20 via the external pressurizing structure and effect release of the drug reservoir 40.

Referring to fig. 1 to 3, optionally, the first tube 13 has a guide wire cavity 131 penetrating opposite ends thereof; the guide wire cavity 131 can be used for threading a guide wire, and the guide wire can guide the catheter 100 to be inserted into the focal zone 62; in particular, the guidewire is capable of being used with a catheter assembly to be inserted into a tissue or organ 60 having a stenosed passageway, such as a blood vessel, fallopian tube, and digestive tract, to treat a focal zone 62.

Referring to fig. 1, 7 and 9, optionally, a developing mark 133 is disposed on the outside of the first tube 13, where the developing mark 133 is located on the first bag 20. It will be appreciated that in this embodiment, the position of the first balloon 20 may be determined by the development mark 133 to accurately deliver the first balloon 20 to the focal zone 62.

Referring to fig. 1 to 3, optionally, in some embodiments, a second flow channel 16 is further formed between the second tube 14 and the first tube 13; wherein the second flow channel 16 and the first flow channel 15 are isolated from each other. It can be understood that the second pipe body 14 is sleeved outside the first pipe body 13, and a predetermined space is formed between the second pipe body and the first pipe body 13; the first flow channel 15 and the second flow channel 16 can be separated by two partition plates which are arranged at intervals and distributed along the circumferential direction of the first pipe body 13, wherein two ends of any partition plate are respectively in sealing contact with the first pipe body 13 and the second pipe body 14.

Optionally, in some embodiments, the tube assembly 10 further has a pressurizing end 12 disposed away from the insertion end 11, the pressurizing end 12 being capable of inputting a medium into the first flow channel 15 to switch the first bladder 20 to the expanded state, the end of the insertion end 11 being disposed with a tapered cross-sectional area in a direction away from the pressurizing end 12. It will be appreciated that the pressurizing end 12 can be connected to an external pressurizing structure to pressurize the first fluid passage 15 by the pressurizing structure, thereby expanding the first bladder 20 and releasing the drug storage body 40; the pressurizing end 12 may also be used to input a fluid having a predetermined temperature into the first bladder 20 to cause the drug storage body 40 to be heated and deployed to release the drug 50 stored therein. It will be appreciated that the tapered cross-sectional area of the end of the insertion end 11 in the direction away from the charging end 12 helps to prevent the wall surface of the end from snagging the tissue wall 61 during insertion of the insertion end 11 to cause injury to the human body.

Referring to fig. 1, it can be understood that the pressurizing end 12 is provided with a first pressurizing port 151 communicating with the first flow channel 15, a second pressurizing port 161 communicating with the second flow channel 16, and a wire guiding port 132 communicating with the wire guiding cavity 131; the first pressurizing port 151 may be connected to an external pressurizing structure to input gas or liquid into the first flow channel 15, so as to switch the first bladder 20 to an inflated state after being pressurized; the second pressurizing port 161 may also be connected to an external pressurizing structure to input gas or liquid into the second flow channel 16, so as to switch the second bladder 30 to an inflated state after being pressurized; the guidewire port 132 allows a guidewire to extend therethrough into the guidewire lumen 131.

The present application also contemplates a method of delivering a drug 50 for delivering the drug 50 to a focal zone 62. The method for delivering the drug 50 is implemented by using the catheter 100, and the specific structure of the catheter 100 refers to the above embodiments, and since the method adopts all the technical solutions of all the above embodiments, the method also has all the beneficial effects brought by the technical solutions of the above embodiments, which are not described in detail herein. Wherein, the treatment method comprises three steps of intervention, pressurization and drug release. Alternatively, the present embodiment is performed in the following order:

s1: insertion, extending the insertion end 11 into the focal zone 62;

s2: pressurizing, namely inputting a medium into the first flow channel 15 to switch the first bag body 20 to an expanded state and press the medicine storage body 40 to abut against the human viscera of the focus area 62;

s3: the medicine releasing body 40 is connected with the viscera of the human body in the focus area 62 and releases the medicine 50 to the focus area 62.

It will be appreciated that in this embodiment, the folds or grooves in the outer surface of the first bladder 20 are gradually stretched during the transition to the inflated condition, and the respective reservoirs 40 are exposed. The first bag body 20 continues to expand, so that the medicine storage body 40 is pressed against the human viscera of the focus area 62, and is stably connected to the outer surface of the human viscera; at the same time, the flow of blood or other body fluids within the focal zone 62 is restricted to reduce or prevent the loss of the drug reservoir 40 from flushing. Thereafter, the drug reservoir 40 is coupled to the body organ of the focal zone 62 and releases the drug 50 to the focal zone 62 in an appropriate manner. Specifically, the drug reservoir 40 is formed of a material that can be degraded to release the drug 50; when the drug storage body 40 is made of a material having shape memory, the drug storage body 40 can be unfolded to release the drug 50 by: hot water or hot air having a proper temperature is injected into the first bladder 20 through the first flow passage 15; heating the drug reservoir 40 by body temperature; energizing the drug storage body 40; applying radio frequency or X-ray energy to the drug storage body 40 by a suitable means; introducing a light source into the tube assembly 10 and causing the light source to illuminate the drug storage body 40 to cause it to expand; the magnetic field is used to heat the drug reservoir 40. The manner in which the drug storage body 40 is deployed as mentioned in the foregoing embodiment is equally applicable to the present method. In the case where the medicine storage body 40 is made of a degradable memory material, the medicine is slowly released after the medicine storage body 40 is unfolded, and after the medicine is released, the medicine storage body 40 is degraded in the living body without any toxic or side effect.

In the drug release step, after the drug storage body 40 is unfolded, the saw teeth 41 at the opening 42 of the drug storage body can be embedded into the tissue wall 61 at the focal zone 62 so as to form a closed environment with the human viscera at the focal zone 62, and the drug 50 flows to the corresponding part of the human viscera and adheres to the corresponding wall surface. After that, the medicine 50 is released to the wall surface of the human organ for a certain period of time.

Optionally, the drug 50 delivery method may be applied in drug 50 therapy, further comprising the steps of:

s4: contracting, namely decompressing the first balloon and the second balloon to ensure that the first balloon and the second balloon are in a contracted state;

s5: retracting, retracting catheter 100 outside the body along the arrival time housed within its guidewire lumen 131;

s6: suturing, performing local compression hemostasis on the wound on the surface of the human body for the insertion end 11 or suturing hemostasis by a suturing device, and completing the interventional treatment process.

The catheter 100 of the present application may be applied to organs or tissues such as the stomach, intestines, trachea, blood vessels, etc., and the focal zone 62 may be a tumor, tumor mass, thrombus, inflammatory tissue, etc.

The foregoing is merely an alternative embodiment of the present application and is not intended to limit the present application. Various modifications and variations of the present application will be apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A catheter for delivering a drug to a focal zone, the catheter comprising:

a drug storage body made of degradable material and containing the drug;

the first bag body is unfolded on the outer surface of the first bag body in an expanded state, the medicine storage body is released to the focus area, and the medicine storage body is pressed to be abutted against the human viscera of the focus area, so that the medicine storage body is pressed between the human viscera and the outer wall of the first bag body;

the drug storage body has a curled state and an expanded state to switch from the curled state to the expanded state; when the medicine storage body is in the curled state, the medicine is wrapped and contained; when the medicine storage body is in the unfolding state, the medicine storage body is provided with an opening, the medicine storage body is arranged in a hemispherical shape or bowl shape in the unfolding state, the medicine is released from the opening, a plurality of saw teeth are arranged at the opening, each saw tooth can be inserted into a human organ of a focus area so that the medicine storage body is connected with the human organ, the medicine can be directionally released to the corresponding part of the human organ through the opening, a wrapping layer is arranged outside the medicine, the wrapping layer has viscosity, and the medicine can be adhered to the corresponding part of the human organ through the wrapping layer after being released by the medicine storage body;

switching the drug storage body to the deployed state and releasing the drug by at least one means comprising:

injecting hot water or hot gas with proper temperature into the first bag body through the first runner;

heating the medicine storage body through body temperature;

energizing the medicine storage body;

applying radio frequency or X-ray energy to the drug reservoir;

introducing a light source into the tube body assembly, and enabling the light source to irradiate the medicine storage body so as to enable the medicine storage body to be unfolded; or (b)

The drug storage body is heated using a magnetic field.

2. The catheter of claim 1, wherein magnetic particles are disposed within the drug reservoir, the drug reservoir exerting a force on the focal zone under the influence of an external magnetic field.

3. The catheter of claim 1, wherein an outer surface of the first balloon is provided with an adhesive layer that adheres to the drug storage body.

4. The catheter of claim 1, further comprising a second balloon connected to the insertion end and capable of elastic expansion, the tube assembly further having a second flow passage in communication with the second balloon, the second flow passage capable of inputting a medium to the second balloon to expand the second balloon and abut the body organ to block blood flow between the first balloon and the second balloon.

5. A catheter according to any of claims 1-3, wherein the catheter body assembly comprises a first catheter body and a second catheter body; the second pipe body is sleeved outside the first pipe body, and the first flow passage is formed between the second pipe body and the first pipe body.

6. The catheter of claim 1, wherein the tube assembly further has a plenum end disposed distally from the insertion end, the plenum end being capable of inputting a medium to the first flow passage to switch the first balloon to the expanded state, the end of the insertion end being tapered in cross-sectional area in a direction away from the plenum end.