CN115501459A - Catheter structure and drug delivery method - Google Patents

Abstract

The invention belongs to the field of medical instruments, and particularly relates to a catheter structure and a medicine conveying method. The catheter structure includes: the medicine storage body is made of degradable materials and contains medicines; a first balloon made of an elastic material and having an expanded state and a contracted state; when the first capsule body is in a contraction state, the outer surface of the first capsule body contracts and clamps the medicine storage body; the first capsule body is connected to the inserting end, and the pipe body assembly is provided with a first flow channel; the first flow passage is used for inputting media to the first balloon so as to switch the first balloon to the expansion state; wherein, the first bag body is expanded on the outer surface and releases the medicine storage body to the focus area under the expansion state, and presses the medicine storage body to abut against the human organ of the focus area. The present invention provides a catheter assembly that can reduce drug loss.

Description

Catheter structure and drug delivery method

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a catheter structure and a medicine conveying method.

Background

The sacculus dilating catheter is an interventional medical appliance, mainly comprises a sacculus and a tube body component, and is often matched with a guide wire to be used together for treating vascular diseases; the saccule after the intervention of the blood vessel is inflated and expanded, thereby dredging the blocked blood vessel. In addition, the balloon dilatation catheter can also carry medicines to perform medicine treatment on the lesion part; specifically, a drug coating is usually coated on the outer surface of the balloon, and after the balloon dilatation catheter is inserted into a blood vessel, the drug is released to a diseased part in a proper manner; the medicine can be used for treating the blood vessel while physically dredging the blood vessel. Compared with the treatment mode of implanting a stent, the balloon dilatation catheter is used for treatment in the mode, side effects of an operation can be reduced, and therefore the balloon dilatation catheter and the balloon catheter coated with the drug are widely applied.

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

Disclosure of Invention

An object of the embodiments of the present application is to provide a catheter structure and a method for drug delivery, which aim to solve the problem of how to reduce drug loss.

In order to achieve the purpose, the technical scheme adopted by the application is as follows:

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

the medicine storage body is made of degradable materials and contains the medicines;

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

the body assembly is provided with an insertion end used for being inserted into the focus area, the first bag body is connected to the insertion end, and the body assembly is provided with a first flow passage; said first flow passage for delivering media to said first bladder to switch said first bladder to said inflated state;

the first bag body is expanded on the outer surface and can release the medicine storage body to the focus area under the expansion state, and the medicine storage body is pressed to be abutted against human viscera of the focus area.

Optionally, in some embodiments, the drug reservoir is made of a memory material and has a rolled state and a deployed state, the drug reservoir 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 drug storage body is in the unfolded state, the drug storage body is provided with an opening from which the drug is released.

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

Optionally, in some embodiments, a plurality of saw teeth are disposed at the opening, and each of the saw teeth is capable of being inserted into a human organ of the focal zone.

Optionally, in some embodiments, magnetic particles are disposed within the reservoir, and the reservoir exerts a force on the focal zone under the influence of an external magnetic field.

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

Optionally, in some embodiments, the catheter structure further comprises a second balloon connected to the insertion end and capable of being elastically expanded, and the catheter body assembly further comprises a second flow channel communicating with the second balloon, the second flow channel being capable of delivering a medium to the second balloon to expand the second balloon and abut the human organ to block 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 a first flow passage is formed between the second pipe body and the first pipe body.

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

In another aspect, there is provided a method of drug delivery using the catheter structure, the method of drug delivery comprising the steps of:

intervening, extending the insertion end into the focal zone;

pressurizing, namely inputting a medium into the first flow channel to switch the first bag body to the expansion state and press the medicine storage body to abut against the human organ of the focus area; and

releasing the medicine, wherein the medicine storage body is connected with the human organ of the focal region and releases the medicine to the focal region.

The beneficial effect of this application lies in: the insertion end extends into a focus area, and the first bag body holding the medicine storage body and the human organ of the focus area are oppositely arranged; pressurizing the first balloon through the first flow passage so as to switch the first balloon to an expansion 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 organ of the focal region, so that the medicine storage body can be connected with the human organ and releases the medicine to the human organ of the focal region in modes of unfolding and/or self degradation and the like. Wherein, the first bag body gradually compresses the medicine storage body between the human organ and the outer wall thereof in the expansion process, and then continuously expands to ensure 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 organ so as to limit the blood flow therein; and in the process of releasing the medicine from the medicine storage body, the medicine storage body is tightly connected with the human viscera of 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 loss of the medicine.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or exemplary technical descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on the drawings without creative efforts.

FIG. 1 is a schematic structural diagram of a catheter structure provided in an embodiment of the present application;

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

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

fig. 4 is a schematic structural diagram of a first bladder in a deflated state according to an embodiment of the present application;

fig. 5 is a schematic structural view of a first bladder in a deflated state according to another embodiment of the present application;

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

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

FIG. 8 is a schematic view of the catheter structure of FIG. 1 inserted at a focal zone with the first balloon in a deflated state and the relative positions of the medicament, tissue wall, medicament reservoir and first balloon;

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

FIG. 10 is a schematic view of the catheter structure of FIG. 1 showing the relative positions of the drug, the tissue wall, the drug reservoir and the first balloon when the first balloon is in an inflated state and the reservoir is in contact with a lesion;

FIG. 11 is a schematic view of the catheter structure of FIG. 1 showing the relative positions of the drug, the tissue wall, the drug reservoir and the first balloon when the first balloon is in an inflated state and the drug reservoir is deployed and attached to the lesion;

FIG. 12 is a schematic view of the catheter structure of FIG. 1 showing the relative positions of the drug, the tissue wall, the drug reservoir and the first balloon when the first balloon is in an inflated state and the drug reservoir is connected to the lesion and releases the drug;

fig. 13 is a schematic view showing the relative positions of the drug, the tissue wall, the drug storage body and the first balloon when the first balloon is in a contracted state and the drug storage body is separated from the first balloon and connected with a lesion site in the catheter structure shown in fig. 1.

Wherein, in the figures, the respective reference numerals: 100. a conduit structure; 10. a tube body assembly; 11. an insertion end; 12. a pressurizing end; 13. a first pipe body; 131. a guidewire lumen; 132. a wire guide opening; 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 fishtail-shaped groove; 23. a flap; 24. a gap; 30. a second bladder; 40. a medicine storage body; 41. saw teeth; 42. an opening; 50. a drug; 60. a tissue or organ; 61. a tissue wall; 62. the focal zone.

Detailed Description

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

It will be understood that when an element is referred to as being "secured to" 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 terms "upper", "lower", "left", "right", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed in a specific orientation, and operate, and thus are not to be construed as limiting the present application, and the specific meanings of the above terms may be understood by those skilled in the art according to specific situations. The terms "first", "second" and "first" are used merely for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "plurality" is two or more unless explicitly defined otherwise.

Referring to fig. 1, 3 and 8, in accordance with an exemplary embodiment of the present disclosure, a catheter structure 100 is provided for delivering a drug 50 to a focal zone 62. The catheter structure 100 includes a drug reservoir body 40, a first balloon and a catheter body assembly 10. Wherein, the medicine storage body 40 is made of degradable material and contains the medicine 50. The first bladder 20 is made of an elastic material and has an expanded state and a contracted state; and the first capsule 20 is in the contracted state, the outer surface of the first capsule 20 contracts and holds the drug storage body 40. A tube assembly 10 having an insertion end 11 for being inserted into the focal zone 62, the first bladder 20 being connected to the insertion end 11, and the tube assembly 10 having 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, in the inflated state, the first bladder 20 expands its outer surface to release the drug reservoir 40 to the focal zone 62, and presses the drug reservoir 40 against the organs of the body of the focal zone 62. Referring to fig. 8, optionally, in some embodiments, the focal zone 62 is located on an inner wall of a tissue or organ 60, such as a blood vessel of a human body.

The drug storage body 40 is made of degradable material. In particular, the drug reservoir 40 may be made of a biodegradable material that is capable of being absorbed under the body of the organism to release the drug 50 to the corresponding site of the focal zone 62. Optionally, the drug reservoir body 40 is made of one or more of polylactic acid based polymers, polyolefin polymers and polyester materials. It will be appreciated that the drug reservoir 40, after being delivered to the focal zone 62 via the first bladder 20, is released upon switching of the first bladder 20 to the expanded state, thereby enabling connection to the human organs of the focal zone 62 and gradually degrading to release the drug 50 stored therein to that location. In addition, the medicine storage body 40 is biodegradable, so that no large toxic or side effect is brought.

Drug 50 may be a lipid soluble drug 50. Optionally, the drug 50 is one or more of an anti-cancer drug, an anticoagulant, and a microbial immunosuppressive agent. Optionally, the drug 50 is one or more of paclitaxel or lipid soluble drugs such as rapamycin and sirolimus.

The surface of the first capsule 20 is formed with folds or grooves in the contracted state; the drug storage body 40 can be provided in plurality, wherein a part of the drug storage body 40 can be contained in the folds or the grooves, and the other part of the drug storage body 40 can be attached to other parts of the outer surface of the first capsule body 20. Referring to fig. 3, in the inflated state, the first bladder 20 is folded or unfolded to discharge the medicine storage 40 stored therein; after the first bag 20 is inflated and has a smooth outer surface, each drug storage body 40 is completely exposed and can be pressed by the outer surface of the first bag 20 to the corresponding part of the visceral organs of the patient 62, so that the drug 50 can be released thereto.

The tube assembly 10 may be integrally formed, or may include a plurality of members and jointly form an assembly body having the first flow channel 15. Wherein the first flow passage 15 communicates both the interior of the first bladder 20 and the external pressurizing structure; the external pressurizing structure is capable of delivering media to the first bladder 20 through the first flow passage 15; the medium may be a gas, liquid or other fluid capable of causing the first bladder 20 to switch from the deflated state to the inflated state.

It can be understood that the insertion end 11 is extended into the focal region 62, and the first bag body 20 holding the drug storage body 40 is arranged opposite to the human organ of the focal region 62; pressurising the first bladder 20 through the first flow passage 15 to switch the first bladder 20 to the inflated condition; 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 organs of the focal region 62, so that the drug storage body 40 can be connected to the human organs and release the drug 50 to the human organs of the focal region 62 by unfolding and/or self-degradation. Wherein, the first bag body 20 gradually compresses the medicine storage body 40 between the human organ and the outer wall thereof in the expansion process, and then 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 40, is attached to the human organ to limit the blood flow therein; and during the process of releasing the drug 50 from the drug reservoir 40, it is tightly connected to the organs of the patient 62, which helps to prevent the drug 50 from being washed away by blood. In conclusion, the application solves the technical problem of how to reduce the loss of the drug 50.

In addition, because the loss of the medicine 50 is small, and the utilization rate of the medicine 50 is high, the quantity of the medicine 50 carried by the first capsule body 20 is small when the capsule is used for treatment, and the production cost is further reduced; and also helps to reduce the toxicity of the drug 50 to the human body system, as the amount of drug 50 that flows to other parts of the human body is reduced.

Optionally, a wrapping layer is arranged outside the drug 50; the coating layer can be liposome, hydrogel, micelle, vesicle or degradable macromolecular molecule; the medicine 50 is wrapped by the wrapping layer and then contained in the medicine storage body 40. It can be understood that the wrapping layer has strong viscosity, and the medicine 50 can be adhered to the corresponding parts of the human viscera through the wrapping layer positioned outside the medicine storage body 40 after being released, so that the medicine 50 is prevented from being lost 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 has a fishtail groove 22 formed in its surface when in the deflated state; the notches of the fishtail groove 22 can be closed, and narrow spaces can be opened to enable the medicine storage body 40 to be stored in the groove. Optionally, a plurality of fishtail grooves 22 are formed when the first capsule 20 is in the contracted state; a plurality of medicine storage bodies 40 are accommodated in any fishtail-shaped groove 22. It will be appreciated that each fishtail 22 will expand to provide a smoother surface when the first bladder 20 is in the expanded state, and that each reservoir 40 will be exposed for connection to the organs of the patient area 62.

Referring to fig. 5, optionally, in some embodiments, the first bladder 20 is provided with a flap 23 on its surface when in the deflated state; each flap 23 can be spirally arranged along 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 the drug reservoir 40 therein will be exposed to connect the organs of the body at the focal zone 62.

Alternatively, in some embodiments, the drug reservoir 40 is made of a memory material and has a rolled state and a deployed state, the drug reservoir 40 being heated to switch from the rolled state to the deployed state. In fig. 8 and 10, the medicine storage body 40 is in a curled state; the drug storage body 40 is in a rolled state, and wraps and stores the drug 50. In fig. 6 and 11 to 13, the drug storage body 40 is in a deployed state; with the body 40 in the deployed state, the 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 body 40 is in a rolled state prior to heating and is capable of encasing the medicament 50 to prevent the medicament 50 from being lost under the scouring action of blood; the drug storage body 40 is switched to the unfolded state after being heated, and the opening 42 is connected with the human organ and the drug 50 is released at the opening 42, so that the drug 50 can be directionally released to the corresponding part of the human organ through flowing out of the opening 42, and further the loss caused by the flow of the drug 50 to other directions is avoided.

Alternatively, the drug reservoir 40 is made of a high molecular polymer material having a shape memory effect. In particular, the drug reservoir 40 may be made from 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 performance, basically has very good high mechanical strength and flexibility, and the deformation temperature of the material can be adjusted to be close to the temperature of a human body; therefore, the drug release device is suitable for surgical operation or medical instrument intervention bodies, is easily deformed to the unfolding state by heating to release the drug 50, and is not easy to generate rejection with human bodies. Optionally, the drug reservoir body 40 is made of one or more materials of high trans polyisoprene, polynorbornene, polyurethane, and styrene-butadiene copolymer.

It will be appreciated that the 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 high trans polyisoprene material has a deformation temperature of 50 to 60 degrees, and the drug reservoir 40 made therefrom unfolds and releases the drug 50 at 50 to 60 degrees. It is understood that the material has the shape memory effect because it has a reversible phase and a stationary phase, and the reversible phase can be transformed into a 'soft-hard' phase under the stimulation of an external field, so that deformation and fixed deformation can be realized. The reversible phase "soft-hard" transition is achieved by a phase change of the polymer, such as a transition from crystalline to molten, or from glassy to elastomeric, at the crystalline melting and glass transition temperatures, respectively. The stationary phase is formed by chemical crosslinking or physical crosslinking of polymer chains, and can prevent molecular slippage and stress relaxation, thereby helping the freezing and memory of deformation and stress.

Optionally, the drug reservoir 40 is made of a degradable high molecular polymer material with shape memory effect. After the medicine storage body 40 is unfolded, the medicine 50 is slowly released, and after the medicine 50 is released, the medicine storage body 40 is degraded in a living body without generating any toxic and side effects.

It will be appreciated that the drug reservoir body 40 may be switched to the deployed state and release the drug 50 by one or more of the following means: injecting hot water or hot gas having a proper temperature into the first capsule 20 through the first flow passage 15; the medicine storage body 40 is heated by body temperature; electrifying the medicine storage body 40; applying radio frequency or X-ray energy to the reservoir body 40 by suitable means; introducing a light source into the conduit assembly and causing the light source to illuminate the drug reservoir body 40 to cause it to expand; the drug storage body 40 is heated using a magnetic field.

Referring to fig. 8 and 10, optionally, in some embodiments, the drug storage body 40 is disposed in a closed shape such as a steamed stuffed bun shape or a ball shape when being in a rolled state. It will be appreciated that in these embodiments, the medicament 50 can be wrapped and enclosed within the interior of the bun-like or ball-like body 40 to avoid loss from blood wash.

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

Referring to fig. 6, optionally, in some embodiments, the opening 42 is provided with a plurality of saw teeth 41, and each saw tooth 41 can be inserted into the human organ of the focal zone 62. It can be understood that each saw tooth 41 is exposed when the drug storage body 40 is in the unfolded state and can be inserted into the corresponding part of the human organ, so that the drug storage body 40 is stably connected with the human organ without falling off or generating a gap locally, and the loss of the drug 50 is reduced.

Optionally, in some embodiments, magnetic particles are disposed within the drug reservoir 40, and the drug reservoir 40 exerts a force on 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 and less likely to become dislodged by the action of the applied magnetic field, thereby helping to reduce the loss of the drug 50.

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

Referring to fig. 1, 7 and 9, optionally, in some embodiments, the catheter structure 100 further includes a second balloon 30 connected to the insertion end 11 and capable of being elastically expanded, and the catheter body assembly 10 further includes a second flow channel 16 communicating with the second balloon 30, wherein the second flow channel 16 is capable of delivering a medium to the second balloon 30 to expand the second balloon 30 and abut the organ of the human body to block the blood flow between the first balloon 20 and the second balloon 30. Wherein, in fig. 1 and 9, the first capsule 20 and the second capsule 30 are both in an inflated state; in fig. 7, both the first 20 and second 30 bladders are in a deflated state. It will be appreciated that the second balloon 30 can be introduced into the focal zone 62 with the first balloon 20 for use with the first balloon 20; specifically, the second bladder 30 expands and abuts against the corresponding part of the organ of the human body and restricts the flow of blood or other body fluids between itself and the first bladder 20, thereby preventing the first bladder 20 from being washed away and causing the loss of the drug 50 when the drug reservoir 40 is released. Wherein the second bladder 30 may be inflated prior to the first bladder 20. Optionally, the second capsule 30 is located at the front end of the insertion end 11 in the direction of insertion. Alternatively, focal zone 62 is located on an inner wall of a tissue or organ 60, such as a blood vessel of the body; it will be appreciated that the insertion end 11 is adapted to extend into a tissue or organ 60, such as a blood vessel, with the first balloon 20 disposed opposite the focal zone 62; pressurizing the second bladder 30 through the second flow passage 16 so that the second bladder 30 is expanded and abuts against a circumference of the inner wall of the tissue or organ 60 such as a blood vessel to block the blood flow therein, and pressurizing the first bladder 20 through the first flow passage 15 so that the first bladder 20 is switched to an expanded state to release the drug storage body 40 clamped on the outer surface thereof and to press the drug storage body 40 between the outer surface thereof and the tissue wall 61 of the lesion 62; the drug 50 may be released to the corresponding site of the focal zone 62 by unfolding or degrading the drug reservoir 40 in a suitable manner.

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 tube 14 is sleeved outside the first tube 13, and a first flow channel 15 is formed between the second tube and the first tube 13. It is understood that the first tube 13 and the second tube 14 can be integrally formed, or can be separately machined and assembled to form the tube assembly 10; wherein, the first tube body 13 and the second tube body 14 are both made of flexible materials and can be inserted into the human body parts with narrow passages, such as blood vessels, oviducts, digestive tracts and the like; the first pipe 13 has a small cross-sectional area and can allow the second pipe 14 having a large cross-sectional area to be inserted therein to form the first flow path 15. It will be appreciated that the first fluid passage 15 can be used to communicate between the first capsule 20 and an external pressurizing structure to pressurize the first capsule 20 by the external pressurizing structure and effect the release of the drug reservoir 40.

Referring to fig. 1 to 3, optionally, the first tube 13 has a guide wire chamber 131 formed therein through opposite ends thereof; the guide wire cavity 131 can be used for a guide wire to penetrate through, and the guide wire can guide the catheter structure 100 to intervene in the focus area 62; in particular, the guide wire enables the catheter assembly to be introduced into a tissue or organ 60 having a narrow passageway, such as a blood vessel, fallopian tube, and alimentary tract, to treat a focal zone 62.

Referring to fig. 1, 7 and 9, optionally, a developing mark 133 is disposed on the exterior of the first tube 13, and the developing mark 133 is located at the position of the first capsule 20. It is understood that in this embodiment, the position of the first capsule 20 may be determined by the visualization mark 133 to accurately deliver the first capsule 20 to the focal zone 62.

Referring to fig. 1 to 3, optionally, in some embodiments, a second flow passage 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 after the second tube 14 is sleeved outside the first tube 13, a predetermined space is formed between the second tube and the first tube 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 arranged along the circumferential direction of the first pipe body 13, wherein two ends of any partition plate are respectively in sealing and abutting contact with the first pipe body 13 and the second pipe body 14.

Optionally, in some embodiments, the cartridge assembly 10 further has a charging end 12 disposed away from the insertion end 11, the charging end 12 being capable of inputting media to the first flow passage 15 to switch the first bladder 20 to the expanded state, the end of the insertion end 11 being tapered in cross-sectional area in a direction away from the charging end 12. It will be appreciated that the charging end 12 can be connected to an external charging structure to charge the first flow passage 15 through the charging structure to inflate the first bladder 20 and release the drug reservoir 40; the pressurizing end 12 may also be used to input a fluid having a predetermined temperature into the first capsule 20 so as to thermally expand the drug storage body 40 to release the drug 50 stored therein. It can be understood that the end of the insertion end 11 is tapered along the transverse sectional area away from the pressurizing end 12, which helps to prevent the wall surface of the end from scratching the tissue wall 61 and causing injury to human body when the insertion end 11 is inserted.

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 passage 15, a second pressurizing port 161 communicating with the second flow passage 16, and a wire guiding port 132 communicating with the wire guiding cavity 131; wherein the first inflation port 151 may be connected to an external inflation 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 inflated; the second inflation port 161 may also be connected to an external inflation structure to input gas or liquid into the second flow channel 16, so as to switch the second bladder 30 to the inflated state; the guidewire port 132 allows a guidewire to extend therethrough into the guidewire lumen 131.

The present invention also contemplates a method of delivering a medication 50 for delivery to a focal zone 62. The method for delivering the drug 50 is implemented by using the catheter structure 100, and the specific structure of the catheter structure 100 refers to the above embodiments, and since the method adopts all technical solutions of all the above embodiments, all the beneficial effects brought by the technical solutions of the above embodiments are also achieved, and are not repeated herein. The treatment method comprises three steps of intervention, pressurization and drug release. Optionally, this embodiment is performed in the following order:

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

s2: pressurizing, inputting a medium into the first flow channel 15 to switch the first bladder 20 to an expanded state, and pressing the drug storage body 40 against the human organ of the focal zone 62;

s3: releasing the drug, the drug reservoir 40 is connected to the human viscera of the focal zone 62 and releases the drug 50 to the focal zone 62.

It will be appreciated that in this embodiment, the folds or grooves in the outer surface of the first bladder 20 gradually unfold and expose the drug reservoirs 40 during switching to the expanded state. The first bag 20 is expanded continuously, so that the medicine storage body 40 is pressed against the human viscera of the focus area 62, and the medicine storage body is stably connected to the outer surfaces 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 due to erosion. Thereafter, the drug reservoir 40 is attached to the human organ of the focal zone 62 and releases the drug 50 to the focal zone 62 by suitable means. Specifically, the drug reservoir body 40 is formed of a material that can be degraded to release the drug 50; when the drug reservoir 40 is made of a material having shape memory, the drug reservoir 40 may be deployed to release the drug 50 by: injecting hot water or hot gas having a proper temperature into the first capsule 20 through the first flow passage 15; the medicine storage body 40 is heated by body temperature; electrifying the medicine storage body 40; applying radio frequency or X-ray energy to the reservoir body 40 by suitable means; introducing a light source into the conduit assembly and causing the light source to illuminate the drug reservoir body 40 to cause it to expand; the drug storage body 40 is heated using a magnetic field. The manner in which the reservoir body 40 is deployed as mentioned in the previous examples is equally applicable to the present method. When the drug storage body 40 is made of degradable memory material, the drug is slowly released after the drug storage body 40 is unfolded, and after the drug is released, the drug storage body 40 is degraded in the organism without generating any toxic and side effects.

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

Alternatively, the drug 50 delivery method may be applied in drug 50 therapy, which further comprises the steps of:

s4: deflating, namely decompressing the first balloon and the second balloon so as to enable the first balloon and the second balloon to be in a deflated state;

s5: retracting the catheter structure 100 out of the body when it is received in its guidewire lumen 131;

s6: and (4) suturing, namely performing local pressurization hemostasis or suturing hemostasis on the surface wound of the human body for inserting the end 11 by using a suturing device to finish the interventional therapy process.

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

The above are merely examples of the present application and are not intended to limit the present application. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement or the like made within the spirit and principle of the present application shall be included in the scope of the claims of the present application.

Claims (10)

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

the medicine storage body is made of degradable materials and contains the medicines;

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

the body assembly is provided with an insertion end used for being inserted into the focus area, the first bag body is connected to the insertion end, and the body assembly is provided with a first flow passage; said first flow passage for inputting a medium to said first bladder to switch said first bladder to said inflated state;

wherein, when the first bag body is in an expansion state, the outer surface of the first bag body is unfolded and can release the medicine storage body to the focus area, and the medicine storage body is pressed to be abutted against the human organ of the focus area.

2. The catheter structure of claim 1, wherein the drug reservoir is made of a memory material and has a crimped state and a deployed state, the drug reservoir being heated to switch from the crimped state to the deployed state; when the medicine storage body is in the curled state, the medicine is wrapped and contained; when the drug storage body is in the unfolded state, the drug storage body is provided with an opening, and the drug is released from the opening.

3. The conduit structure of claim 2 wherein said drug storage body is hemispherical or bowl-shaped in said deployed state.

4. The catheter structure of claim 2, wherein the opening is provided with a plurality of serrations, each serration being adapted to be inserted into a human organ of the focal zone.

5. The catheter structure according to any of claims 1 to 4, wherein magnetic particles are disposed in the drug reservoir, and the drug reservoir exerts a force on the focal zone under the influence of an external magnetic field.

6. The catheter structure of any one of claims 1-4, wherein the outer surface of the first balloon is provided with an adhesive layer, said adhesive layer adhering the drug reservoir.

7. The catheter structure of any one of claims 1-4, further comprising a second balloon connected to the insertion end and capable of being elastically expanded, the tube assembly further having a second fluid channel in communication with the second balloon, the second fluid channel capable of delivering a medium to the second balloon to expand the second balloon and abut the human organ to block blood flow between the first balloon and the second balloon.

8. The catheter structure of any one of claims 1-4, wherein the tube assembly comprises a first tube and a second tube; the second pipe body is sleeved outside the first pipe body, and a first flow passage is formed between the second pipe body and the first pipe body.

9. The catheter structure of any one of claims 1-4, wherein the catheter body assembly further has a pressurizing end disposed distal from the insertion end, the pressurizing end capable of delivering media to the first flow channel to switch the first balloon to the expanded state, the insertion end having an end that tapers in cross-sectional area in a direction away from the pressurizing end.

10. A method for drug delivery carried out using the catheter structure according to any one of claims 1 to 9, comprising the steps of:

intervening, extending the insertion end into the focal zone;

pressurizing, namely inputting a medium into the first flow channel to switch the first bag body to the expansion state and press the medicine storage body to abut against the human organ of the focus area; and

releasing the medicine, wherein the medicine storage body is connected with the human organ of the focal region and releases the medicine to the focal region.

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