CN114949551A - Porous balloon catheter system and method of use - Google Patents
Porous balloon catheter system and method of use Download PDFInfo
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- CN114949551A CN114949551A CN202110609446.4A CN202110609446A CN114949551A CN 114949551 A CN114949551 A CN 114949551A CN 202110609446 A CN202110609446 A CN 202110609446A CN 114949551 A CN114949551 A CN 114949551A
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
Abstract
The invention relates to the technical field of medical instruments, and provides a porous balloon catheter system and a using method thereof. The porous balloon catheter system comprises a balloon catheter and an ultrasonic transducer, wherein the balloon catheter comprises a balloon body, an inner tube and an outer tube, the ultrasonic transducer is arranged in the inner tube and located inside the balloon body, a plurality of medicine outlet holes are formed in the surface of the balloon body, and the interval between every two adjacent medicine outlet holes is 0.5-2.5 mm. According to the porous balloon catheter system and the use method thereof, the medicine outlet holes with reasonable intervals are adopted, so that the expected pressure in the balloon body is achieved, the medicine coverage rate of a lesion part is high, and the medicine dosage is accurate; or, two or more than two ultrasonic transducers are connected in parallel, so that the permeability of the medicine to the pathological change tissue is increased, the medicine absorption effect is improved, and the problems that the medicine falls off in the process of conveying the medicine to the targeted pathological change and the dosage cannot be accurately controlled in the conventional medicine balloon are solved.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a porous balloon catheter system and a using method thereof.
Background
Cardiovascular stenosis is one of the major causes of Coronary heart disease, and interventional therapy (PCI) is an important means for treating cardiovascular stenosis. Interventional therapy is an effective treatment method for vascular diseases such as coronary artery disease, peripheral artery disease, intracranial artery disease, and the like. A novel technology for preventing restenosis of blood vessels after interventional therapy operation, namely a drug coating balloon, appears in recent years, and the basic principle of the drug coating balloon is that specific drugs are coated on the surface of a balloon body, the balloon body is conveyed to a focus and positioned through a guide catheter and a guide wire, the balloon body is mechanically expanded by pressurization, and the drug coating on the surface of the balloon body is in close contact with the wall of the focus blood vessel, so that the drugs are quickly released and absorbed by the wall of the focus blood vessel, and the effect of treating vascular diseases is achieved.
Since the drug-coated balloon blocks blood flow when the drug-coated balloon is in an inflated state, how to improve the absorption effect of the drug is very critical and necessary for the drug-coated balloon therapy. According to the related art that the inventor knows, in some medicine sacculus products, ultrasonic transducer is placed to the inside of sacculus body, and after the sacculus body expands, sacculus body surface medicine coating and focus vascular wall in close contact with, under ultrasonic transducer arouses, the medicine is with higher speed to permeate the pathological change internal surface to improve the absorption effect of medicine.
However, since the drug is coated on the outer surface of the balloon, a large amount of the drug is shed during the delivery of the balloon catheter to the lesion, there is a risk of distal embolization, and the dosage is not accurate.
Disclosure of Invention
The invention aims to provide a porous balloon catheter system and a using method thereof, and aims to solve the technical problems of inaccurate dosage and poor drug absorption effect of the conventional drug balloon.
In order to achieve the purpose, the invention adopts the technical scheme that: a porous balloon catheter system comprises a balloon catheter and an ultrasonic transducer, wherein the balloon catheter comprises a balloon body, an inner tube and an outer tube, the outer tube is connected to the near end of the balloon body, one end of the inner tube is located in the outer tube, the other end of the inner tube penetrates through the balloon body and is connected to the far end of the balloon body, a channel is formed between the inner tube and the outer tube and is communicated with the inside of the balloon body, the ultrasonic transducer is used for converting electric energy into ultrasonic vibration, the ultrasonic transducer is mounted in the inner tube and located in the balloon body, a plurality of medicine outlet holes are formed in the surface of the balloon body, and the interval between every two adjacent medicine outlet holes is 0.5-2.5 mm.
In one embodiment, the drug outlet hole comprises a plurality of hole groups, each hole group comprises a plurality of circumferential holes, the circumferential holes are distributed at equal intervals in the circumferential direction of the balloon body, and the hole groups are distributed at equal intervals in the axial direction of the balloon body.
In one embodiment, the spacing between adjacent circumferential holes in each of the hole sets is equal to the spacing between adjacent circumferential holes.
In one embodiment, a plurality of the hole sets are arranged in parallel along the circumferential direction of the balloon body.
In one embodiment, two adjacent hole sets are staggered along the circumferential direction of the balloon body.
In one embodiment, the circumferential holes are equally spaced.
In one embodiment, the diameter of the medicine outlet hole is 1-20 μm.
In one embodiment, the medicine outlet hole is a circular hole.
In one embodiment, the porous balloon catheter system further comprises a visualization ring that is sleeved on the inner tube and is located inside the balloon body.
In one embodiment, the porous balloon catheter system further comprises a pressure pump, the pressure pump is connected to one end, away from the balloon body, of the inner tube, and is used for injecting the drug-loaded microspheres into the channel and enabling the internal pressure of the balloon body to be 6atm to 14atm when the balloon body is expanded.
The invention also provides a porous balloon catheter system which comprises a balloon catheter and two or more ultrasonic transducers, wherein the balloon catheter comprises a balloon body, an inner tube and an outer tube, the outer tube is connected to the near end of the balloon body, one end of the inner tube is positioned in the outer tube, the other end of the inner tube penetrates through the balloon body and is connected to the far end of the balloon body, a channel is formed between the inner tube and the outer tube and is communicated with the inside of the balloon body, the ultrasonic transducers are used for converting electric energy into ultrasonic vibration, the ultrasonic transducers are arranged in the inner tube and are positioned in the balloon body, the number of the ultrasonic transducers is two or more, and the two or more ultrasonic transducers are connected in parallel.
In one embodiment, the ultrasonic transducer is in a hollow cylindrical shape, and the ultrasonic transducer is fixedly sleeved on the inner tube.
In one embodiment, the wall thickness of the ultrasonic transducer is 0.1 mm-1 mm.
In one embodiment, the length of the ultrasonic transducer is 0.5 mm-5 mm.
In one embodiment, the inner diameter of the ultrasonic transducer is 0.4 mm-1.5 mm.
In one embodiment, the ultrasonic transducer is a piezoelectric ceramic post;
wherein the positive pole of the piezoelectric ceramic column is positioned on one of the inner surface of the piezoelectric ceramic column and the outer surface of the piezoelectric ceramic column, and the negative pole of the piezoelectric ceramic column is positioned on the other of the inner surface of the piezoelectric ceramic column and the outer surface of the piezoelectric ceramic column;
or the positive electrode of the piezoelectric ceramic column and the negative electrode of the piezoelectric ceramic column are both positioned on the outer surface of the piezoelectric ceramic column.
In one embodiment, the porous balloon catheter system further comprises an ultrasonic controller, the ultrasonic controller is electrically connected with the ultrasonic transducer, and the ultrasonic controller controls the sound pressure value of the ultrasonic waves generated by the ultrasonic transducer by changing the input voltage value of the ultrasonic transducer.
In one embodiment, the porous balloon catheter system further comprises a temperature sensor for detecting the temperature of the ultrasonic transducer, and the temperature sensor is electrically connected with the ultrasonic controller, so that the ultrasonic controller controls the temperature of the ultrasonic transducer to be 37-43 ℃.
The invention also provides a use method of the porous balloon catheter system, which is applied to any one of the porous balloon catheter systems and comprises the following steps:
inputting physiological saline into the channel to discharge gas in the balloon body;
inserting a distal portion of the inner tube into a blood vessel to bring the balloon body into proximity of a lesion;
inputting a solution containing drug-loaded microspheres into the channel so that the drug-loaded microspheres enter the balloon body and the pressure of the balloon body is at a preset pressure value;
activating an ultrasonic transducer and keeping the ultrasonic transducer working for a preset time period.
The porous balloon catheter system and the use method thereof provided by the invention have the beneficial effects that: the medicine is conveyed through the channel, so that the medicine is prevented from falling off in the process of conveying to the targeted lesion, and the dosage is accurately controlled; adopt the reasonable medicine hole in interval, guarantee that this internal medicine coverage that reaches anticipated pressure and pathological change department of sacculus is high, the medicine covers evenly, thereby the medicine absorption effect is good under ultrasonic wave's effect, perhaps, adopt two and more than ultrasonic transducer parallel connection, increase the permeability of medicine to pathological change tissue, improve the medicine absorption effect, it is not accurate to have solved current medicine sacculus existence dosage, the poor technical problem of medicine absorption effect, thereby reduce the waste of medicine, the medicine absorption effect is improved, therapeutic effect is improved.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive exercise.
Fig. 1 is a schematic structural diagram of a porous balloon catheter system provided in an embodiment of the present invention;
FIG. 2 is an enlarged view taken at A in FIG. 1;
FIG. 3 is a schematic view of one configuration of the balloon body of the porous balloon catheter system of FIG. 1;
FIG. 4 is another schematic structural view of the balloon body of the porous balloon catheter system of FIG. 1;
FIG. 5 is a schematic flow chart of a method of using a porous balloon catheter system provided by an embodiment of the present invention;
FIG. 6 is a comparison of the longitudinal sections of blood vessels in the experimental group (left) and the control group (right) in the first set of experiments;
FIG. 7 is a comparison of the axial dissection of blood vessels in the experimental group (left) and the control group (right) in the first set of experiments;
FIG. 8 is a photograph of the blood vessel wall of a control group in a second set of experiments;
FIG. 9 is a photograph of the vessel wall in the second set of experiments;
FIG. 10 is a photograph of the vessel wall at an injection pressure of 4atm in the third set of experiments;
FIG. 11 is a photograph of the vessel wall at an injection pressure of 8atm in the third set of experiments;
FIG. 12 is a blood vessel wall image of 12atm injection pressure in the third set of experiments.
Wherein, in the figures, the respective reference numerals:
100-balloon catheter, 110-balloon body, 111-drug outlet hole, 112-hole group, 113-circumferential hole, 114-proximal end, 115-distal end, 120-inner tube, 130-outer tube, 140-channel, 200-ultrasonic transducer, 300-developing ring, 400-pressure pump, 500-ultrasonic controller.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
In the description of the present invention, it is to be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are merely for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
Example one
Referring to fig. 1 and 2, a porous balloon catheter system includes a balloon catheter 100 and an ultrasonic transducer 200, the balloon catheter 100 includes a balloon body 110, an inner tube 120 and an outer tube 130, the outer tube 130 is connected to a proximal end 114 of the balloon body 110, one end of the inner tube 120 is located in the outer tube 130, the other end of the inner tube 120 penetrates through the balloon body 110 and is connected to a distal end 115 of the balloon body 110, a channel 140 is formed between the inner tube 120 and the outer tube 130, the channel 140 is communicated with an interior of the balloon body 110, and a plurality of drug outlets 111 are formed on a surface of the balloon body 110.
In use, the ends of inner tube 120 and outer tube 130 distal to balloon body 110 are located outside the human body, and have an entrance to channel 140 for medical personnel to add medication through the entrance to channel 140. The medicine passes through passageway 140 and carries to sacculus body 110 in, leaves sacculus body 110 through sacculus body 110's play medicine hole 111 again, injects in vascular wall or other tissues, rather than the surface that sacculus body 110 was scribbled in advance to avoid inner tube 120 and sacculus body 110 to take place the medicine and drop inserting the vascular in-process, both reduced the loss waste of medicine, effectively avoid the emergence of distal end embolism again, and can accurate control dose.
In the first set of experiments, please refer to fig. 6 and 7, the above-mentioned porous balloon catheter system was used to administer drug to the left porcine blood vessel of the experimental group, and the right porcine blood vessel of the control group was soaked in the drug microsphere solution for 30 min.
Wherein, the drug microspheres are simulated by adopting fluorescent microspheres. The subdivision of fluorescent microspheres is indicated by bright spots on the vascular tissue. The number and the area of the bright spots can reflect the coverage rate of the fluorescent microspheres and the absorption effect of the vascular tissues on the drugs. The larger the number of bright spots in the vascular tissue and the larger the area of the bright spots, the higher the coverage of the drug, and the better the absorption of the drug. The second and third experiments also use fluorescent microspheres to observe the coverage and absorption effect of the drug, and are not repeated in the following.
As can be seen from fig. 6 and 7, no fluorescent microspheres exist on the vessel wall in the control group, while the experiment group can find very obvious fluorescent microsphere spots, which indicates that the coverage rate of the fluorescent microspheres is high. So, compare medicine coating sacculus, above-mentioned porous sacculus pipe system carries the medicine to the target pathological change in-process, and the medicine loss that drops is few, realizes accurate control dosage.
Optionally, the medicament is a therapeutic medicament for inhibiting cell proliferation and improving the efficacy of interventional procedures.
The ultrasonic transducer 200 is used for converting electric energy into ultrasonic vibration, and the ultrasonic transducer 200 is mounted on the inner tube 120 and located inside the balloon body 110. The ultrasonic wave generated by the ultrasonic transducer 200 can further provide the power for the medicine to pass through the administration hole and enter the vascular wall or other tissues, and can increase the clearance between cells due to the instantaneous pressure generated by the cavitation of the ultrasonic wave, thereby being beneficial to the medicine to enter the vascular wall or other tissues and improving the absorption effect of the medicine.
In some embodiments, referring to fig. 3 and 4, in the plurality of drug outlet holes 111, the interval between two adjacent drug outlet holes 111 is 0.5mm to 2.5mm, so that the balloon body 110 can reach a desired pressure and the coverage rate of the drug at the lesion is high, thereby improving the drug absorption effect and the treatment effect.
If the distance between two adjacent medicine outlet holes 111 is less than 0.5mm, the number of the medicine outlet holes 111 in a unit area is too large, which results in high liquid flow rate, not only the interior of the balloon body 110 cannot be pressurized to the desired pressure, but also the speed of the medicine emitted to the lesion tissue is low due to insufficient pressure, and the medicine is difficult to be absorbed by the tissue, and the physical performance of the balloon body 110 is reduced due to too many medicine outlet holes 111.
If the interval between two adjacent medicine outlet holes 111 is greater than 2.5mm, the number of medicine outlet holes 111 in unit area is too small, the time of medicine injection can be lengthened, the operation time is prolonged, the time that the sacculus body 110 after expansion blocks the blood vessel is too long, and meanwhile, the effective medicine coverage rate cannot be guaranteed due to the too small number of medicine outlet holes 111, and the treatment effect can be influenced.
In other embodiments, referring to fig. 2, the number of the ultrasonic transducers 200 is two or more, the two or more ultrasonic transducers 200 are connected in parallel, and the ultrasonic action mechanisms of the two or more ultrasonic transducers 200 are combined, so that the permeability of the drug to the lesion tissue can be increased, the drug absorption effect can be improved, and the treatment effect can be improved.
In the second set of experiments, please refer to fig. 8, the surface of the balloon body 110 of the porous balloon catheter system used in the control group has a plurality of drug outlets 111, but the ultrasound transducer 200 is not disposed inside the balloon body 110. Referring to fig. 9, the surface of the balloon body 110 of the porous balloon catheter system used in the experimental group has a plurality of drug outlets 111, and two ultrasound transducers 200 connected in parallel are disposed inside the balloon body 110. Under the same experimental conditions, including the same injection pressure (6atm) and the same injection time (2min), the experimental group and the control group show that the final experimental results show that compared with the control group (see fig. 8), the porous balloon catheter system adopting the two ultrasonic transducers 200 connected in parallel has the advantages that the fluorescent microspheres can enter the vessel wall more easily (see fig. 9), the coverage rate of the drugs is higher, and the absorption effect is better.
On the basis of the foregoing embodiment, referring to fig. 3 and 4, the drug outlet hole 111 includes a plurality of hole sets 112 (see the dashed box in fig. 3 and 4), and the hole sets 112 include a plurality of circumferential holes 113.
The plurality of circumferential holes 113 are distributed along the circumferential direction of the balloon body 110 at equal intervals, so that the circumferential stress of the balloon body 110 is uniform, the balloon body 110 is prevented from being torn due to nonuniform stress, the balloon body 110 is ensured to have good physical performance, and medicines are uniformly ejected to the vascular wall along the circumferential direction of the balloon body 110, thereby being beneficial to improving the medicine coverage rate and improving the medicine absorption effect.
The plurality of hole groups 112 are distributed at equal intervals along the axial direction of the balloon body 110, so that the medicines are uniformly ejected to the vessel wall along the axial direction of the balloon body 110, namely, the medicines are uniformly injected into tissues along the length direction of the blood vessel section at the lesion part, the coverage rate of the medicines is improved, and the medicine absorption effect is improved.
All the circumferential holes 113 of all the hole groups 112 are medicine outlet holes 111, and all the circumferential holes 113 are combined into a plurality of medicine outlet holes 111.
Referring to fig. 3, the interval between two adjacent hole sets 112 is b, and the interval between two adjacent circumferential holes 113 in each hole set 112 is c. For any one circumferential hole 113, the interval between adjacent circumferential holes 113 of the same hole group 112 and adjacent circumferential holes 113 of adjacent hole groups 112 is a. The interval b between two adjacent hole sets 112 refers to the axial distance between two adjacent hole sets 112 in the balloon body 110.
Specifically, referring to fig. 3, the interval c between two adjacent circumferential holes 113 in each hole group 112 is equal to the interval b between two adjacent hole groups 112. So, a plurality of medicine holes 111 distribute in sacculus body 110 more evenly, and the medicine is evenly jeted to the vascular wall through a plurality of medicine holes 111, and the application of medicine is more scientific, and the absorption effect and the treatment of medicine are better.
Specifically, referring to fig. 3, a plurality of hole sets 112 are arranged in parallel along the circumferential direction of the balloon body 110. That is, two adjacent hole sets 112 are translated along the axial direction of balloon body 110 and can coincide with each other. That is, any three adjacent three circumferential holes 113 are combined into a right triangle, and two adjacent circumferential holes 113 between adjacent hole groups 112 are located in the same axial direction of the balloon body 110. Thus, the drug outlet holes 111 are distributed on the surface of the balloon body 110 in an array manner, which is beneficial to processing and manufacturing the drug outlet holes 111.
Specifically, referring to fig. 4, two adjacent hole sets 112 are staggered along the circumferential direction of the balloon body 110. Therefore, on the basis of ensuring the material performance of the balloon body 110, the circumferential holes 113 of the two adjacent hole groups 112 can be injected to the vessel wall from more angles along the circumferential direction of the balloon body 110, so that the coverage rate of the medicine is further improved, and the absorption effect of the medicine is improved.
Further, referring to fig. 4, the intervals between two adjacent circumferential holes 113 are equal. In this way, the interval between any two adjacent circumferential holes 113 is equal, and any three adjacent circumferential holes 113 form an equilateral triangle, i.e., in fig. 4, d ═ e ═ f.
On the basis of the foregoing embodiment, please refer to fig. 3, the diameter of the drug outlet 111 is 1 μm to 20 μm. Wherein, the aperture of the medicine outlet 111 is the diameter of the circumcircle of the medicine outlet 111. When the medicine outlet hole 111 is a circular hole, the diameter of the medicine outlet hole 111 is the diameter of the circular hole. When the medicine outlet hole 111 is a rectangular hole, the diameter of the medicine outlet hole 111 is the diameter of the circumscribed circle of the rectangular hole. When the medicine outlet hole 111 is a trapezoidal hole, the diameter of the medicine outlet hole 111 is the diameter of the circumscribed circle of the trapezoidal hole.
In addition to the above embodiments, referring to fig. 3, the medicine outlet 111 is a circular hole. When the circular port can guarantee that sacculus body 110 pressurizes the expansion, the circumference boundary atress of circular port is unanimous, avoids producing inhomogeneous stress because of the circumferencial direction of play medicine hole 111 and leads to sacculus body 110 to tear.
On the basis of the foregoing embodiments, referring to fig. 2, the porous balloon catheter system further includes a developing ring 300, and the developing ring 300 is sleeved on the inner tube 120 and located inside the balloon body 110, so that the developing ring 300 is not easy to fall off and can display the position of the balloon body 110. The developing ring 300 is used for developing imaging, and is convenient for medical staff to perform operations.
Specifically, referring to fig. 2, when the porous balloon catheter system includes two or more ultrasound transducers 200 arranged in parallel, the two or more ultrasound transducers 200 can be controlled individually, and whether the two or more ultrasound transducers 200 are activated or not and the input voltage value of each ultrasound transducer 200 can be selectively controlled individually.
For example, with the aid of the developing ring 300, the pathological changes of the blood vessel and the dosage of each part are observed, and if the pathological changes of a certain section of the blood vessel are serious or the dosage is insufficient, the ultrasonic transducer 200 at the part is independently controlled to be activated, or the input voltage value of the ultrasonic transducer 200 at the part is independently increased, so that the dosage of the blood vessel at the part is improved, and the dosage is accurately controlled.
Based on the foregoing embodiment, when the balloon body 110 is expanded, a certain pressure is provided inside the balloon body 110, which can promote the drug to pass through the drug delivery hole and enter the blood vessel wall or other tissues.
Specifically, referring to fig. 1, the porous balloon catheter system further includes a pressure pump 400, the pressure pump 400 is connected to one end of the inner tube 120 away from the balloon body 110, and the pressure pump 400 is configured to inject the drug-loaded microspheres into the channel 140 and make the internal pressure of the balloon body 110 be 6atm to 14atm when the balloon body 110 is expanded.
In a third set of experiments, please refer to fig. 10 to 12, at an injection time of 2min, images of fluorescent microspheres entering the vessel wall under different injection pressures were obtained by using the porous balloon catheter system provided in this embodiment. Fig. 10 is a blood vessel wall image of 4atm injection pressure in the third set of experiments, fig. 11 is a blood vessel wall image of 8atm injection pressure in the third set of experiments, and fig. 12 is a blood vessel wall image of 12atm injection pressure in the third set of experiments.
Referring to fig. 10, when the injection pressure is 4atm, the coverage of the fluorescent microspheres is low, the drug is not easy to enter the vascular wall tissue, and the drug absorption effect is poor.
Referring to fig. 11, when the injection pressure is 8atm, the coverage of the fluorescent microspheres is good, the drug easily enters the vessel wall, and the drug absorption effect is good.
Referring to fig. 12, when the injection pressure is 12atm, the coverage of the fluorescent microspheres is very good, and the drug absorption effect is very good.
It should be added that the greater the injection pressure, the better the drug absorption. When the injection pressure exceeds 14atm, the physical properties of the balloon body 110 are greatly damaged, and the balloon is easy to crack, so that the risk of operation exists.
On the basis of the foregoing embodiments, referring to fig. 1, the ultrasonic transducer 200 is in a hollow cylindrical shape, and the ultrasonic transducer 200 is fixedly sleeved on the inner tube 120.
In one embodiment, the wall thickness of the ultrasonic transducer 200 is 0.1mm to 1 mm.
In one embodiment, the ultrasound transducer 200 has a length of 0.5mm to 5mm to ensure compliance of the inner tube 120, thereby facilitating insertion of the inner tube 120 into the blood vessel.
In one embodiment, the inner diameter of the ultrasonic transducer 200 is 0.4mm to 1.5mm, which can reduce the maximum outer diameter of the inner tube 120, and further expand the application range of the porous balloon catheter system.
Optionally, the end of balloon body 110 has a prong with a diameter greater than 1mm to facilitate passage of ultrasound transducer 200 into the interior of balloon body 110.
On the basis of the foregoing embodiment, referring to fig. 2, the ultrasonic transducer 200 is a piezoelectric ceramic column. Piezoelectric ceramics typically comprise polycrystalline materials (e.g., ferroelectric ceramics) that change shape when an alternating electric field is applied across the piezoelectric ceramic, thereby generating vibrations that induce acoustic waves.
Alternatively, the positive electrode of the piezoelectric ceramic post is located on one of the inner surface of the piezoelectric ceramic post and the outer surface of the piezoelectric ceramic post, and the negative electrode of the piezoelectric ceramic post is located on the other of the inner surface of the piezoelectric ceramic post and the outer surface of the piezoelectric ceramic post.
For example, the positive electrode of the piezoelectric ceramic column is located on the inner surface of the piezoelectric ceramic column, and the negative electrode of the piezoelectric ceramic column is located on the piezoelectric ceramic column. For another example, the cathode of the piezoelectric ceramic column is located on the inner surface of the piezoelectric ceramic column, and the anode of the piezoelectric ceramic column is located on the outer surface of the piezoelectric ceramic column.
Therefore, the positive electrode and the negative electrode of the piezoelectric ceramic column are respectively positioned at the inner side and the outer side of the piezoelectric ceramic column, so that the wires can be conveniently and orderly connected, and wiring is convenient.
It is understood that in other embodiments, the positive electrode of the piezoelectric ceramic column and the negative electrode of the piezoelectric ceramic column are both located on the outer surface of the piezoelectric ceramic column, so that one end of the wire is respectively welded with the positive electrode and the negative electrode of the piezoelectric ceramic column, and the other end of the wire is used for connecting with an external control device.
The positive electrode and the negative electrode of the piezoelectric ceramic column can be positioned on the outer surface of the piezoelectric ceramic simultaneously in a wrapping mode.
On the basis of the foregoing embodiment, the ultrasonic transducer 200 is connected to an external device through a conductive wire embedded in the inner tube 120, and the ultrasonic transducer 200 is used to generate ultrasonic waves of 1MHz to 15 MHz.
On the basis of the foregoing embodiment, please refer to fig. 1, the porous balloon catheter system further includes an ultrasound controller 500, the ultrasound controller 500 is electrically connected to the ultrasound transducer 200, and the ultrasound controller 500 is configured to control a sound pressure value of the ultrasound waves generated by the ultrasound transducer 200.
Wherein, the medical staff can conveniently control the sound pressure value of the ultrasonic wave generated by the ultrasonic transducer 200 by controlling the input voltage value of the ultrasonic controller 500.
Specifically, the ultrasound controller 500 is electrically connected to the ultrasound transducer 200 by a wire.
Specifically, the porous balloon catheter system further includes a temperature sensor (not shown) for detecting the temperature of the ultrasound transducer 200, and the temperature sensor is electrically connected to the ultrasound controller 500, so that the ultrasound controller 500 controls the temperature of the ultrasound transducer 200 to be 37 ℃ to 43 ℃.
The porous balloon catheter system provided by the invention can effectively improve the absorption of tissues to the medicines for inhibiting cell proliferation and the metabolism dynamics of the medicines in a human body, so that the curative effect of interventional operations on cardiovascular and cerebrovascular and peripheral blood vessels can be greatly improved.
Example two
Referring to fig. 5, the present invention further provides a method for using a porous balloon catheter system, which is applied to any one of the above porous balloon catheter systems, and comprises the following steps:
s100: saline is input to channel 140 to vent the gas within balloon body 110.
Optionally, the saline solution contains a contrast agent, which facilitates the contrast display of the developing ring 300 and the observation of the internal conditions of the blood vessel by medical personnel.
S200: the distal portion of inner tube 120 is inserted into the vessel so that balloon body 110 reaches the vicinity of the lesion.
S300: a solution containing drug-loaded microspheres is input into the channel 140, so that the drug-loaded microspheres enter the balloon body 110, and the pressure of the balloon body 110 is at a preset pressure value.
Specifically, a solution containing drug-loaded microspheres is injected into channel 140 using pressure pump 400.
Optionally, the preset pressure value is 6atm to 12 atm.
S400: the ultrasonic transducer 200 is activated and the ultrasonic transducer 200 is kept in operation for a preset period of time.
Optionally, the preset time period is 1min to 2 min.
The use method of the porous balloon catheter system provided by the invention has the beneficial effects that: the medicine is conveyed through the channel 140 of the inner tube 120, so that the falling of the medicine in the process of inserting the inner tube 120 into the blood vessel is avoided, and the utilization rate of the medicine is improved; adopt the reasonable medicine hole 111 that goes out in interval, guarantee to reach the medicine coverage of anticipated pressure and pathological change department in the sacculus body 110 high, thereby it is effectual to absorb the medicine under the effect of ultrasonic wave, improve medicine availability ratio, perhaps, adopt two and more than ultrasonic transducer 200 parallel connection, increase the permeability of medicine to pathological change tissue, improve the availability ratio of medicine, the technical problem that current medicine sacculus has medicine availability ratio low has been solved, thereby reduce the waste of medicine, the medicine absorption effect has been improved, therapeutic effect has been improved.
Optionally, after step S400, the following steps are further included:
s500: and (3) closing the ultrasonic transducer 200, and withdrawing the inner tube 120 after the balloon body 110 is decompressed.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (16)
1. A porous balloon catheter system characterized by: the balloon catheter comprises a balloon catheter body, an inner tube and an outer tube, wherein the outer tube is connected to the near end of the balloon body, one end of the inner tube is located in the outer tube, the other end of the inner tube penetrates through the balloon body and is connected to the far end of the balloon body, a channel is formed between the inner tube and the outer tube and is communicated with the inside of the balloon body, the ultrasonic transducer is used for converting electric energy into ultrasonic vibration and is installed in the inner tube and located in the balloon body, a plurality of medicine outlet holes are formed in the surface of the balloon body, and the interval between every two adjacent medicine outlet holes is 0.5-2.5 mm.
2. The porous balloon catheter system of claim 1, wherein: the medicine outlet holes comprise a plurality of hole groups, each hole group comprises a plurality of circumferential holes, the circumferential holes are distributed along the circumferential direction of the balloon body at equal intervals, and the hole groups are distributed along the axial direction of the balloon body at equal intervals.
3. The porous balloon catheter system of claim 2, wherein: the interval between two adjacent circumferential holes in each hole group is equal to the interval between two adjacent hole groups.
4. The porous balloon catheter system of claim 2, wherein: the hole groups are arranged in parallel along the circumferential direction of the balloon body.
5. The porous balloon catheter system of claim 2, wherein: two adjacent hole groups are arranged along the circumferential direction of the balloon body in a staggered manner.
6. The porous balloon catheter system of claim 5, wherein: the interval between two adjacent circumferential holes is equal.
7. The porous balloon catheter system of claim 1, wherein: the aperture of the medicine outlet hole is 1-20 μm, and/or the medicine outlet hole is a circular hole.
8. The porous balloon catheter system of claim 1, wherein: the porous balloon catheter system further comprises a developing ring, and the developing ring is sleeved on the inner tube and located inside the balloon body.
9. The porous balloon catheter system according to any one of claims 1-8, wherein: the porous balloon catheter system further comprises a pressure pump, the pressure pump is connected to the inner tube and is far away from one end of the balloon body, the pressure pump is used for injecting medicine carrying microspheres into the channel, and the internal pressure of the balloon body is 6 atm-14 atm when the balloon body is expanded.
10. A porous balloon catheter system characterized by: the balloon catheter comprises a balloon catheter body, an inner tube and an outer tube, wherein the outer tube is connected to the near end of the balloon body, one end of the inner tube is located in the outer tube, the other end of the inner tube penetrates through the balloon body and is connected to the far end of the balloon body, a channel is formed between the inner tube and the outer tube and is communicated with the inside of the balloon body, the ultrasonic transducer is used for converting electric energy into ultrasonic vibration and is installed in the inner tube and located in the balloon body, the number of the ultrasonic transducers is two or more, and the two or more ultrasonic transducers are connected in parallel.
11. The porous balloon catheter system of claim 10, wherein: the ultrasonic transducer is in a hollow cylindrical shape and is fixedly sleeved on the inner pipe.
12. The porous balloon catheter system of claim 11, wherein: the ultrasonic transducer further satisfies at least one of the following conditions:
the wall thickness of the ultrasonic transducer is 0.1 mm-1 mm;
the length of the ultrasonic transducer is 0.5 mm-5 mm;
the inner diameter of the ultrasonic transducer is 0.4 mm-1.5 mm.
13. The porous balloon catheter system of claim 11, wherein: the ultrasonic transducer is a piezoelectric ceramic column;
wherein the positive pole of the piezoelectric ceramic column is positioned on one of the inner surface of the piezoelectric ceramic column and the outer surface of the piezoelectric ceramic column, and the negative pole of the piezoelectric ceramic column is positioned on the other of the inner surface of the piezoelectric ceramic column and the outer surface of the piezoelectric ceramic column;
or the positive electrode of the piezoelectric ceramic column and the negative electrode of the piezoelectric ceramic column are both positioned on the outer surface of the piezoelectric ceramic column.
14. The porous balloon catheter system according to any one of claims 10-13, wherein: the porous balloon catheter system further comprises an ultrasonic controller, wherein the ultrasonic controller is electrically connected with the ultrasonic transducer, and the ultrasonic controller controls the sound pressure value of the ultrasonic waves generated by the ultrasonic transducer by changing the input voltage value of the ultrasonic transducer.
15. The porous balloon catheter system of claim 14, wherein: the porous balloon catheter system further comprises a temperature sensor, the temperature sensor is used for detecting the temperature of the ultrasonic transducer, and the temperature sensor is electrically connected with the ultrasonic controller, so that the ultrasonic controller controls the temperature of the ultrasonic transducer to be 37-43 ℃.
16. A method for using a porous balloon catheter system, which is applied to the porous balloon catheter system according to any one of claims 1 to 15, wherein: the method comprises the following steps:
inputting physiological saline into the channel to discharge gas in the balloon body;
inserting a distal portion of the inner tube into a blood vessel to bring the balloon body into proximity of a lesion;
inputting a solution containing drug-loaded microspheres into the channel so that the drug-loaded microspheres enter the balloon body and the pressure of the balloon body is at a preset pressure value;
activating an ultrasonic transducer and keeping the ultrasonic transducer working for a preset time period.
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