CN114010917A - Double-medicine administration balloon - Google Patents
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- CN114010917A CN114010917A CN202111305196.1A CN202111305196A CN114010917A CN 114010917 A CN114010917 A CN 114010917A CN 202111305196 A CN202111305196 A CN 202111305196A CN 114010917 A CN114010917 A CN 114010917A
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Abstract
The invention discloses a double-drug administration balloon, which comprises a balloon body and a connecting pipe which are connected, wherein the balloon body comprises a first balloon, a second balloon sleeved in the first balloon and a balloon tip connected to the same end of the first balloon and the second balloon, the first balloon and the second balloon are separated from each other to form a first injection channel, the second balloon is of a hollow structure, a first pressure charging and releasing channel is formed in the second balloon, a first microneedle array is arranged on the surface of the first balloon, a second microneedle array is arranged on the surface of the second balloon, the second microneedle array and the first microneedle array are arranged in a staggered mode, the first balloon is used for carrying a first drug, and the first injection channel is used for conveying a second drug. The double-drug administration balloon can realize double-drug administration, reduce the operation time, inject the drug into the intima and the media of the blood vessel, improve the utilization rate of the drug after wall expansion, and ensure that the injection distribution of the drug is more uniform and the treatment effect is better and the restenosis can be better prevented because the micro-needles are widely distributed and have large areas.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a double-drug administration balloon for interventional therapy of vascular diseases and prevention of restenosis of blood vessels after therapy.
Background
Vascular intervention is an important treatment for revascularization of stenotic lesions, and restenosis is usually caused by the proliferation of smooth muscle cells in the media.
For vascular interventional therapy, in the drug-eluting stent era, in-stent restenosis (ISR) still occurs occasionally, and once it occurs, there is a lack of effective treatment. The superimposition of another drug stent within the restenosis drug stent can result in a subsequent restenosis incidence of up to 43%.
In recent years, new devices and treatment strategies have been emerging to overcome the above difficulties, and a Drug-coated balloon (DCB), a product of traditional balloon angioplasty coupled with advanced Drug elution techniques, is increasingly showing its superiority as an effective complement to stenting. DCB is not only simple and convenient to operate, but also has unique advantages on stent restenosis, bifurcation lesion, small vessel lesion, severe bending calcification lesion and the like. However, the DCB still has the problems of serious loss of the drug on the surface of the balloon during the interventional process, short contact time with the blood vessel wall, low drug utilization efficiency and the like.
In addition, for restenosis, multiple sites of simultaneous and uniform administration are generally required for good therapeutic effect. However, the currently used balloon dilatation catheter with injection function is limited by the number of injection needles, is difficult to administer to a plurality of parts at one time, requires multiple adjustment of the position of the microneedle and multiple injections to achieve the expected effect, and greatly increases the operation duration and the risk of patients. And in some cases it may be desirable to co-administer one drug with another to take advantage of the synergy between the two drugs, however, where the two drugs cannot be stored together due to incompatibility issues, co-administration of the two drugs cannot be achieved.
Therefore, there is a need for a novel drug delivery balloon to reduce the drug loss during the intervention process, improve the utilization rate of the drugs after the wall expansion, and provide two drugs in a separate manner to reduce the operation time.
Disclosure of Invention
The invention aims to provide a double-drug administration balloon, which is used for reducing the drug loss in the intervention process, improving the utilization rate of the drugs after wall expansion, and reducing the operation time by giving two drugs in a time.
In order to achieve the purpose, the technical scheme of the invention is as follows: the utility model provides a two medicines sacculus of dosing, it is including the sacculus body and the connecting pipe that link to each other, wherein, the sacculus body includes first sacculus, cover and locates second sacculus in the first sacculus and connect in both with the sacculus tip of one end, first sacculus the looks interval and form first injection channel between the second sacculus, the second sacculus is hollow structure and its inside first pressure release passageway that fills that forms, the surface of first sacculus is equipped with first micropin array, the surface of second sacculus is equipped with second micropin array, second micropin array with first micropin array dislocation set, first sacculus is used for carrying first medicine, first injection channel is used for carrying the second medicine.
Preferably, the connecting pipe is including outer tube and the inner tube that is hollow structure, the second injection passageway and the second that are equipped with mutual isolation in the outer tube fill the pressure release passageway, the second injection passageway with first injection passageway is linked together and is used for carrying the second medicine, the second fill the pressure release passageway with first fill the pressure release passageway and be linked together and be used for filling the pressure release, the inner tube is worn to locate the second fill the pressure release passageway first fill the pressure release passageway the sacculus is most advanced and its inside formation seal wire chamber. The second medicine is input through the connecting pipe, and the medicine amount can be adjusted, so that a good treatment effect is ensured.
Preferably, the surface of first sacculus is equipped with hydrophilic coating, a plurality of shrinkage pools have been seted up to hydrophilic coating, the shrinkage pool intussuseption is filled with first medicine, a plurality of first micropins that first micropin array included all bulge in hydrophilic coating, a plurality of second micropins that second micropin array included correspond respectively the shrinkage pool setting. According to the balloon body, the concave holes are used for carrying the first medicine, so that the adsorption quantity of the first medicine is greatly improved, the loss quantity of the first medicine carried by the first balloon is greatly reduced due to the fact that the first medicine is washed by blood in the conveying process of the balloon body, the medicine loss rate is greatly reduced, and the medicine can effectively reach a diseased part to play a role in treatment.
Preferably, the distribution of the concave holes is 4-8/mm2And the minimum distance between two adjacent concave holes is 0.08-0.25 mm.
Preferably, the first microneedle and the second microneedle are both molded by high molecular polymer or metal material, and the first microneedle and the second microneedle are fixed by glue, adhesive or welding; and the height of the first microneedle is 0.10-1.0mm, the height of the second microneedle is 0.50-1.5mm, and the second microneedle is longer than the first microneedle so as to ensure that the second microneedle can sufficiently puncture the first balloon.
Preferably, the balloon body has a folded state and an expanded state, in the folded state, the first microneedle is wrapped in the inside of the surface of the first balloon, the second microneedle is wrapped in the inside of the surface of the second balloon, in the expanded state, the first microneedle protrudes out of the surface of the first balloon, and the second microneedle protrudes out of the surface of the second balloon. According to the special folding mode of the balloon body, the microneedles are wrapped in the balloon in a folding state, so that the blood vessels cannot be damaged in the process of intervention and conveying, and the balloon is restored to the folding state again after the balloon is expanded and decompressed, so that the microneedles can be prevented from remaining in the blood vessel wall, the microneedles are more convenient to retract, and the problems that a plurality of independent microneedles on the balloon are incompletely recovered and difficult to retract in the prior art are solved.
Preferably, in the folded state, the portion of the first balloon where the first microneedles are fixed is recessed inward to form a first recessed portion, so that the end portions of the first microneedles are lower than the surface of the first balloon in the radial direction of the first balloon, the portion of the second balloon where the second microneedles are fixed is recessed inward to form a second recessed portion, and the end portions of the second microneedles are lower than the surface of the second balloon in the radial direction of the second balloon; after the folded state is converted into the expanded state, the first sunken part is radially expanded outwards along the first balloon to enable the first microneedles to be protruded out of the surface of the first balloon, and the second sunken part is radially expanded outwards along the second balloon to enable the second microneedles to be protruded out of the surface of the second balloon.
Preferably, the first balloon is a non-compliant balloon and the second balloon is a semi-compliant balloon or a compliant balloon, such that the second balloon can continue to expand under pressure to pass the second microneedles through the first balloon. Therefore, when the drug is administered, the first microneedle and the second microneedle penetrate into the inner wall of the blood vessel, the drug is injected into the blood vessel tissue by pressure to achieve the purpose of administration, the drug can directly enter the intima and the media of the blood vessel wall, and the first microneedle and the second microneedle can cut pathological changes to a certain extent, reduce the elastic retraction of the pathological changes of the blood vessel, and ensure good treatment effect.
Preferably, the outer tube is provided with an opening communicated with the second pressure charging and discharging channel, the inner tube is arranged through the second pressure charging and discharging channel, the first pressure charging and discharging channel and the balloon tip end by the opening in a penetrating manner, and the inner tube is further provided with a developing ring.
Preferably, the double-drug administration balloon further comprises a base, the base is connected to one end, far away from the balloon body, of the connecting pipe in a sealing manner and is provided with a first cavity channel and a second cavity channel which are isolated from each other, and the first cavity channel and the second cavity channel are respectively communicated with the second injection channel and the second pressure charging and releasing channel.
Compared with the prior art, the dual-drug administration balloon has the following effects: firstly, the balloon body is provided with a first balloon and a second balloon which are sleeved with each other, a first injection channel is formed between the first balloon and the second balloon, the second balloon is of a hollow structure, and a first pressure charging and discharging channel 150 is formed in the second balloon, so that a first medicine is carried by the first balloon, and a second medicine is conveyed by the first injection channel, so that two medicines can be conveyed in a time-by-time manner, double-medicine administration is realized, the operation time is reduced, the adsorption capacity of the first balloon on the first medicine is large, and meanwhile, the medicine loss in the intervention process is reduced, so that the medicine concentration reaching the focus is higher, and the treatment effect is better; secondly, the surface of the first balloon is provided with a first microneedle array, the surface of the second balloon is provided with a second microneedle array, and the second microneedle array and the first microneedle array are arranged in a staggered manner, so that when the drug is administered, the microneedle is penetrated into the inner wall of the blood vessel, and the drug is injected into the blood vessel tissue by pressure to achieve the purpose of drug administration; moreover, the microneedle array is wide in distribution and large in area, so that the injection distribution of the drug is more uniform, the treatment is more effective, and restenosis can be better prevented; finally, the double-drug administration balloon 1 can also be used as a drug injection device, and corresponding drugs can be injected into the vessel wall according to clinical requirements.
Drawings
Fig. 1 is a schematic structural diagram of a dual drug delivery balloon of the present invention.
Fig. 2 is a partial half-section schematic view of fig. 1.
Fig. 3 is an enlarged schematic view of a portion a in fig. 2.
Fig. 4 is a cross-sectional enlarged view of a portion B in fig. 2.
Fig. 5 is a cross-sectional enlarged view of a portion C in fig. 2.
Fig. 6 is a sectional view of the connection pipe of fig. 1.
Fig. 7 is a schematic view of the balloon body of fig. 1 in an expanded state.
Fig. 8 is a cross-sectional view of the balloon body of fig. 1 in a folded state.
Fig. 9 is a partial top view of the balloon body of fig. 7.
Fig. 10 is an enlarged schematic view of a portion D in fig. 5.
Detailed Description
Embodiments of the present invention will now be described with reference to the drawings, wherein like element numerals represent like elements. The directional descriptions referred to in this application, such as the directional descriptions or positional relationships indicated above, below, left, right, front, rear, etc., are based on the directional descriptions or positional relationships shown in the drawings, and are only for convenience of describing the technical solutions or/and simplifying the description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the application. The description of first, second, etc. merely serves to distinguish technical features and should not be interpreted as indicating or implying a relative importance or implying a number of indicated technical features or implying a precedence relationship between indicated technical features.
Referring to fig. 1 to 10, the dual drug administration balloon 1 provided by the present invention includes a balloon body 100, a connecting tube 200, and a base 300. Wherein, sacculus body 100, base 300 are connected respectively in the both ends of connecting pipe 200, and sacculus body 100 is bilayer structure. The detailed structures of the balloon body 100, the connecting tube 200, and the base 300 will be described in detail below with reference to the accompanying drawings.
Referring first to fig. 1-2 and 7-10, in the present invention, the balloon body 100 includes a first balloon 110, a second balloon 120, and a balloon tip 130. The first balloon 110 is sleeved outside the second balloon 120, the first balloon 110 and the second balloon 120 are spaced apart from each other to form a first injection channel 140, the second balloon 120 is hollow and forms a first pressure and pressure charging channel 150 therein, and the first pressure and pressure charging channel 150 is used for charging and discharging pressure. The surface of the first balloon 110 is provided with a first microneedle array, the surface of the second balloon 120 is provided with a second microneedle array, and the second microneedle array is arranged in a staggered manner with respect to the first microneedle array (see fig. 7 and 10). Meanwhile, the distal ends of the first balloon 110 and the second balloon 120 are connected to the balloon tip 130, a guide wire lumen (described in detail later) is provided in the balloon tip 130, and the proximal ends of the first balloon 110 and the second balloon 120 are connected to the connection tube 200. According to the balloon body 100, the first balloon 110 is used for carrying the first medicine 400 (see fig. 9), and the first injection channel 140 is used for conveying the second medicine, so that double-medicine administration can be realized, in addition, when the medicine is administered, the inner wall of a blood vessel is penetrated through a microneedle, and then the medicine is injected into a blood vessel tissue through pressure to achieve the purpose of the medicine administration, so that the medicine can directly enter an inner membrane and a middle membrane of a blood vessel wall, the medicine amount is adjustable, and a good treatment effect is ensured.
More specifically, referring to fig. 7 and 10, the first microneedle array has a plurality of first microneedles 111, and the first microneedles 111 are uniformly disposed on the surface of the first balloon 110 or arranged according to a certain rule. Correspondingly, a plurality of second microneedles 121 of the second microneedle array are uniformly arranged on the surface of the second balloon 120 or arranged according to a certain rule, and the second microneedles 121 are arranged corresponding to the gaps between the first microneedles 111, that is, the second microneedles 121 and the first microneedles 111 are arranged in a staggered manner.
Referring to fig. 1-2, 5, and 7-10, in the present invention, a hydrophilic coating 112 is disposed on a surface of the first balloon 110, the hydrophilic coating 112 has a plurality of concave holes 113, and the concave holes 113 are preferably distributed at 4-8/mm2However, the number distribution of the concave holes 113 is not limited to this, and the number of the concave holes 113 may be flexibly set as needed. In a more preferred embodiment of the invention, shown in figures 9-10, the distribution of the indentations 113 is 4-6/mm2The optimal distribution is 5 pieces/mm2。
In a more specific embodiment of the present invention, a plurality of concave holes 113 are provided in a region between adjacent first microneedles 111, and the plurality of concave holes 113 provided in the region are preferably uniformly arranged, and a minimum distance between two adjacent concave holes 113 in the region is preferably 0.08 to 0.25mm, although the minimum distance between two concave holes 113 in the region is not limited in this embodiment, and can be flexibly provided as needed. With continued reference to fig. 9-10, in a more preferred embodiment of the invention, the minimum spacing between adjacent recesses 113 in this region is 0.10-0.20mm, with the optimum value of the minimum spacing being 0.10-0.15 mm.
Referring to fig. 9 again, the first medicine 400 is disposed in the concave hole 113, and the first medicine 400 is carried by the concave hole 113, so that the adsorption amount of the first medicine 400 is greatly increased, and the loss rate of the first medicine 400 carried by the balloon body 100 due to blood washing is greatly reduced in the conveying process of the balloon body 100, so that more first medicines 400 can effectively reach a diseased region to play a therapeutic role.
As shown below in conjunction with fig. 7-10, in one embodiment of the present invention, the second microneedle 121 is disposed in a staggered manner with respect to the first microneedle 111: the second microneedles 121 are respectively disposed corresponding to the recessed holes 113, as shown in fig. 10. Therefore, after the second balloon 120 is expanded by the pressurization, the second microneedle 121 protrudes out of the concave hole 113, so that the second medicament in the first injection channel 140 seeps out through the concave hole 113 of the first balloon 110, and the second medicament also directly contacts the lesion site and seeps into the intima and media layers of the blood vessel.
Referring again to fig. 1 to 4 and fig. 7 to 10, in the present invention, the first microneedle 111 and the second microneedle 121 are preferably formed of a high molecular polymer, inorganic silicon, or a metal material. The height of the first microneedle 111 is preferably 0.10-1.0mm, the height of the second microneedle 121 is preferably 0.50-1.5mm, and the second microneedle 121 is longer than the first microneedle 111, thereby ensuring that the second microneedle 121 can sufficiently pierce the first balloon 110. Certainly, the heights of the two microneedles are not limited in the embodiment, and the heights of the microneedles can be adjusted according to blood vessels at different positions, so that the first microneedles 111 can only penetrate into the intima or media of the inner wall of the blood vessel without penetrating through the blood vessel wall, the operation risk of a doctor is reduced, and the safety of a patient is guaranteed. The first microneedle 111 can be directly fixed on the surface of the first balloon 110 by glue, adhesive or welding, and the second microneedle 121 can be directly fixed on the surface of the second balloon 120 by glue, adhesive or welding. It is to be understood that the molding material and the fixing manner of the first microneedle 111 and the second microneedle 121 are not limited to those in the present embodiment, and can be flexibly disposed as needed.
Continuing with fig. 7-8, in the present invention, the balloon body 100 has a collapsed state and an expanded state. In the folded state shown in fig. 8, the first balloon 110 is contracted, so that the first microneedles 111 are all wrapped inside the surface of the first balloon 110, and correspondingly, the second balloon 120 is contracted, so that the second microneedles 121 are all wrapped inside the surface of the second balloon 120, thereby facilitating the interventional delivery of the balloon body 100. After the affected site is reached, the balloon body 100 can be converted from the folded state shown in fig. 8 to the expanded state shown in fig. 7 by injecting the second medicament into the first injection channel 140 and pressurizing the first pressurizing/depressurizing channel 150, at this time, the first balloon 110 is expanded, so that the first microneedles 111 protrude out of the surface of the expanded first balloon 110, correspondingly, the second balloon 120 is expanded, the second microneedles 121 protrude out of the surface of the second balloon 120, and the second microneedles 121 can penetrate out of the surface of the first balloon 110. This kind of special folding mode of sacculus body 100 for all cladding of micropin in the sacculus the inside under the fold condition, consequently can not harm the blood vessel intervene the transportation process, and after sacculus body 100 pressure release, the folded condition that fig. 8 is shown can resume once more to sacculus body 100, thereby all the micropins all cladding are in the inside of sacculus body 100 again, not only can avoid the micropin to stay in the vascular wall, still make the withdrawal more convenient, the problem of retrieving incompletely and withdrawing the difficulty appears in having overcome a plurality of independent micropins on the sacculus among the prior art.
As shown in fig. 7 to 8, in an embodiment of the present invention, in the folded state, the portion of the first balloon 110 to which the first microneedles 111 are fixed is recessed into the first recessed portion 110a, that is, the first recessed portion 110a is recessed in the axial direction, and the first microneedles 111 are accommodated in the first recessed portion 110a, so that the ends of the first microneedles 111 are lower than the surface of the first balloon 110 in the radial direction of the first balloon 110, as shown in fig. 8. Accordingly, the second concave portion 120a formed by recessing the portion of the second balloon 120 to which the second microneedle 121 is fixed is formed, that is, the portion to which the second microneedle 121 is fixed is recessed in the axial direction of the second balloon 120 to form the second concave portion 120a, and the second microneedle 121 is accommodated in the second concave portion 120a, so that the end portion of the second microneedle 121 is lower than the surface of the second balloon 120 in the radial direction of the second balloon 120.
In a more preferred embodiment, the second recess 120a is offset from the first recess 110a, that is, the surface of the second balloon 120 higher than the second recess 120a corresponds to the first recess 110a, as shown in fig. 8, but not limited thereto. After the balloon body 100 is transformed from the folded state shown in fig. 8 to the expanded state shown in fig. 7, the first concave portions 110a are expanded outward along the radial direction of the first balloon 110, so that the first microneedles 111 are all protruded out of the surface of the first balloon 110, correspondingly, the second concave portions 120a are expanded outward along the radial direction of the second balloon 120, so that the second microneedles 121 are all protruded out of the surface of the second balloon 120, and the balloon body 100 in the expanded state is shown in fig. 7.
With continued reference to fig. 5 and 7-8, in the present invention, the first balloon 110 is a non-compliant balloon and the second balloon 120 is a semi-compliant balloon or a compliant balloon. That is, the diameter of second balloon 120 increases more significantly than first balloon 110 for the same pressure. Therefore, after the balloon body 100 reaches the lesion site and is converted into the expanded state, a certain amount of second drug solution is injected into the first injection channel 140, so that the first balloon 110 is expanded, the first microneedles 111 penetrate into the intima and the media of the blood vessel, but the blood vessel is not punctured, due to the fact that the first balloon 110 is fully expanded, the first microneedles 111 and the concave holes 113 are fully expanded, the first drugs 400 in the concave holes 113 contact with the blood vessel, and the first drugs 400 are released to the lesion site of the blood vessel and enter the intima and the media of the blood vessel. After the first inflation/deflation channel 150 is inflated, the second balloon 120 can be further expanded, at this time, the first balloon 110 is hardly expanded, the second microneedles 121 penetrate through the outer surface of the first balloon 110 to form micropores, and with the expansion of the second balloon 120, the second medicament in the first injection channel 140 is released to the vascular lesion through the micropores of the first balloon 110 and enters the intima and the media layer of the blood vessel, so that the administration is realized again.
Referring to fig. 1-6, in the present invention, the connection tube 200 includes an outer tube 210 and an inner tube 220, which are hollow, a second injection channel 230 and a second pressure and pressure charging channel 240 are disposed in the outer tube 210, the second injection channel 230 is communicated with the first injection channel 140, and the second pressure and pressure charging channel 240 is communicated with the first pressure and pressure charging channel 150, which is specifically shown in fig. 5; second injection channel 230, first injection channel 140 are used to deliver the second medicament, and second pressure charge and discharge channel 240, first pressure charge and discharge channel 150 are used to charge and discharge pressure. The inner tube 220 is sequentially inserted into the second pressure-charging and-discharging channel 240, the first pressure-charging and-discharging channel 150 and the balloon tip 130, as shown in fig. 1-2, and a guidewire cavity 250 is formed inside the inner tube 220, and the guidewire cavity 250 formed inside the inner tube 220 is communicated with the guidewire cavity formed inside the balloon tip 130, as shown in fig. 3 and 6.
Referring to fig. 4-6, in an embodiment of the present invention, a partition wall 213 is disposed in the outer tube 210, the partition wall 213 extends along an axial direction of the outer tube 210, so as to divide the outer tube 210 into a first tube wall 211 and a second tube wall 212, a space enclosed between the partition wall 213 and the first tube wall 211 forms a second injection channel 230, as shown in fig. 6, and a space enclosed between the partition wall 213 and the second tube wall 212 forms a second inflation/deflation channel 240, as shown in fig. 6. The shape of the partition wall 213 and the position of the partition wall 213 in the outer tube 210 are not particularly limited, and may be flexibly configured according to the requirement, that is, the position and the shape of the partition wall 213 may be flexibly configured according to the size of the second injection channel 230 and the second pressure/charge channel 240.
2-3, 5, further, at both ends of the outer tube 210, the first tube wall 211 is shorter than the second tube wall 212, and the length of the separation wall 213 is the same as that of the second tube wall 212, which is configured to facilitate the connection with the balloon body 100 and the base 300. Referring to fig. 5, when the connection tube 200 is connected to the balloon body 100, the second tube wall 212 and the separation wall 213 are fixed to the second balloon 120, and the first tube wall 211 and the second tube wall 212 are fixed to the first balloon 110, so that the connection with the balloon body 100 having a double-layer structure can be conveniently achieved. The connection between the connection pipe 200 and the base 300 will be described in detail later.
Referring to fig. 2 and 4, in an embodiment of the invention, an opening 214 communicating with the second pressure charging and discharging channel 240 is formed on the outer tube 210, and the opening 214 is particularly formed on the second tube wall 212. Inner tube 220 is disposed through second inflation/deflation channel 240, first inflation/deflation channel, and balloon tip 130 via opening 214. In addition, the tip of the inner tube 220 is inserted into the balloon tip 130, the tip of the inner tube 220 is further provided with a hole communicating with the inside of the inner tube, and the inner tube 220 is further provided with a visual mark for developing, in this embodiment, the inner tube 220 is provided with a developing ring 221, and the arrangement manner of the developing ring 221 is a conventional manner in the art.
Referring to fig. 1-3, in the present invention, the base 300 has a first channel 310 and a second channel 320 which are isolated from each other, the first channel 310 is communicated with the second injection channel 230, and the first channel 310 is used for injecting a medicine, specifically, a second medicine; the second channel 320 is communicated with the second pressure and pressure charging channel 240, and the second channel 320 is used for charging and discharging pressure. Of course, the connection positions of the first channel 310 and the second channel 320 can be interchanged.
Specifically referring to fig. 3, when the base 300 is connected to the connection tube 200, the second injection channel 230 is opposite to the first channel 310, the second pressure/air charging channel 240 can be axially abutted to the second channel 320, and since the end of the first tube wall 211 is shorter than the end of the partition wall 213, the second injection channel 230 can be communicated with the first channel 310, and in order to achieve the sealing connection therebetween, the UV glue 330 is used to seal the space between the outer surface of the first tube wall 211 and the inner wall of the base 300, and the space between the partition wall 213 and the inner wall of the base 300 at the radial position around the first channel 310, so that the first channel 310 and the second injection channel 230 are communicated and sealed; correspondingly, the outer surface of the second tube wall 212 is hermetically connected with the inner wall of the base 300 by the UV glue 330, so that the second cavity channel 320 is communicated with the second pressure and release channel 240 and sealed.
Referring again to fig. 1-3, in one embodiment of the present invention, the base 300 is preferably a Y-shaped base, but is not limited thereto, and may be any base.
The operation of the dual drug delivery balloon 1 of the present invention will now be described with reference again to figures 1-10.
Firstly, the sacculus body 100 with fold condition is taken in and is carried the sheath pipe, carry sacculus body 100 to the pathological change position again, because first micropin 111, second micropin 121 all wraps up in sacculus body 100, consequently can not harm the normal blood vessel of route passed in the sacculus body 100 intervenes transportation process, and carry first medicine 400 by shrinkage pool 113 on the first sacculus 110, make the adsorption capacity to first medicine 400 improve greatly, make sacculus body 100 transportation process, first medicine 400 that first sacculus 110 carried is washed by blood and lost less, make the loss rate greatly reduced of medicine.
After the balloon body 100 reaches the lesion site, the balloon body 100 is completely exposed outside the delivery sheath, and then a certain amount of a second drug solution is injected into the second injection channel 230 and the first injection channel 140 through the first channel 310 of the Y-shaped base 300, as shown by the arrow direction in fig. 5, wherein the second drug is a fast dissolving drug, and the drug form may be powder, microspheres, a coating, or the like, or may be a drug solution. The second drug may be pre-loaded in the first injection channel 140 and then dissolved by injecting a solvent through the first channel 310. The drug solution may also be injected from the first lumen 310 after the start of treatment. The second drug type can be adjusted according to the actual use requirement, and then the first cavity 310 of the Y-shaped base 300 is closed.
At this time, the first balloon 110 is expanded, so that the first microneedles 111 penetrate into the intima and the media of the blood vessel but do not penetrate through the blood vessel, and since the first balloon 110 is sufficiently expanded, the first microneedles 111 and the concave holes 113 are all spread, the first medicine 400 in the concave holes 113 of the hydrophilic coating 112 is released and contacts with the blood vessel, and the first medicine 400 contacts with the lesion site and permeates into the intima and the media of the blood vessel.
Then, the second pressure-filling and releasing channel 240 and the first pressure-filling and releasing channel 150 are pressurized through the second channel 320 of the Y-shaped base 300, as shown in the arrow direction in fig. 5, so that the second balloon 120 is further expanded, during which the first balloon 110 is hardly expanded, so that the second microneedles 121 can pass through the concave holes 113 of the first balloon 110 and protrude out of the outer surface thereof, thereby forming micropores, and as the second balloon 120 is continuously expanded, the second drug in the first injection channel 140 seeps out through the micropores of the first balloon 110, and the second drug contacts the lesion and seeps into the intima and the media layer of the blood vessel.
Above-mentioned twice in-process of dosing, first medicine 400, the equal direct inner membrance and the mesolamella that gets into the vascular wall of second medicine to the dose is all adjustable, thereby guarantees good treatment, and in addition, first micropin 111, the equal cutting pathological change that can to a certain extent of second micropin 121, reduce vascular pathological change elastic retraction, and simultaneously, the distribution of first micropin array, second micropin array is wide, the area is big, can evenly dose, reach better prevention stenosis treatment once more. In addition, the dual-drug administration balloon 1 can also be used as a drug injection device, and corresponding drugs can be injected into the vessel wall according to clinical requirements.
In an embodiment of the invention, at least one of the active agents of the first medicament 400, the second medicament is an mTOR inhibitor and the other medicament is an NF-K inhibitor.
In an embodiment of the invention, the mTOR inhibitor is rapamycin or a rapamycin analogue and the further NF-K inhibitor is curcumin or a curcumin analogue.
In some embodiments of the invention, administration of an mTOR inhibitor in combination with an NF-K inhibitor is effective to treat cell proliferation or restenosis in the luminal region to which it is administered. NF-K inhibitors may include curcumin, sulfadiazine, sulindac, indomethacin, diclofenac, etodolac, meclofenoxate, mefenamic acid, nanoketone, piroxicam, phenylbutazone, meloxicam, dexamethasone, betamethasone dipropionate, diflorosane diacetate, clobetasol propionate, halobetasol propionate, amclomipide, beclomethasone dipropionate, fluorochloromimide, betamethasone valerate, triamcinolone acetonide, penicillamine, hydroxychloroquine, sulfadiazine, azathioprine, minocycline, cyclophosphamide, methotrexate, cyclosporine, leflunomide, etanercept, infliximab, ascomycin, estradiol, rosiglitazone, troglitazone, pioglitazone, S-nitrosoglutathione, gliotoxin.
In some embodiments, the mTOR inhibitor is pegylated. In some embodiments, the pegylated mTOR inhibitor comprises pegylated interferon and interferon.
In other embodiments, the first drug is an immediate release drug and the second drug is a sustained release drug.
In other embodiments, the first agent 400, the second agent is selected from the group consisting of a vasopeptide (somatostatin analog), a calcium channel blocker, an angiotensin converting enzyme inhibitor (captopril, cilazapril), cyclosporine, trapidil (antianginal, antiplatelet), terbinafine (antifungal), colchicine and paclitaxel (antimicrotubulin antiproliferative), and c-myc and c-myb antisense oligonucleotides.
In other embodiments, the first agent 400 and the second agent are selected from the group consisting of heparin, heparin derivatives, heparin fragments, colchicine, steroids, cortisone, paclitaxel, docetaxel, methotrexate, azathiopine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride, mitomycin, heparinoids, hirudin, argatroban, forskolin, vapreoprost, prostacyclin analogs, dextran, dipyridamole, recombinant hirudin, histamine antagonists, lovastatin, dipyridamole, monoclonal antibodies, suramin, serotonin blockers, thiol protease inhibitors, triazolopyrimidines, pemilast potassium, dexamethasone, radioisotopes, and aspirin.
In other embodiments, the first agent 400, the second agent include, but are not limited to, anti-restenosis, pro-or anti-hyperplasia, anti-inflammatory, anti-tumor, anti-mitotic, anti-platelet, anti-coagulant, anti-fibrin, anti-thrombin, cytostatic, antibiotic, anti-enzyme, anti-metabolic, angiogenic, cytoprotective, Angiotensin Converting Enzyme (ACE) inhibition, angiotensin II receptor antagonist and/or cardioprotective agents.
After the two administrations are completed, the first pressure charging and releasing channel 150, the second pressure charging and releasing channel 240 and the second cavity 320 are firstly released, and then the first injection channel 140, the second injection channel 230 and the first cavity 310 are released, so that the balloon body 100 is contracted into the folded state shown in fig. 8, the problem of incomplete microneedle recovery cannot occur, and the normal blood vessel of the path which passes through the balloon body 100 cannot be damaged in the process of withdrawing the balloon body 100.
In summary, the dual drug administration balloon 1 of the present invention has the following effects: firstly, the balloon body 100 is provided with a first balloon 110 and a second balloon 120 which are sleeved with each other, a first injection channel 140 is formed between the first balloon 110 and the second balloon 120, the second balloon 120 is of a hollow structure, and a first pressure charging and discharging channel 150 is formed in the second balloon 120, so that a first medicine 400 is carried by the first balloon 110, and a second medicine is conveyed by the first injection channel 140, so that two medicines can be conveyed in a time-by-time manner, double-medicine administration is realized, the adsorption capacity of the first balloon 110 on the first medicine 400 is large, and meanwhile, the medicine loss in the intervention process is reduced, so that the concentration of the medicine reaching a focus is higher, and the treatment effect is better; secondly, the surface of the first balloon 110 is provided with a first microneedle array, the surface of the second balloon 120 is provided with a second microneedle array, and the second microneedle array and the first microneedle array are arranged in a staggered manner, so that when the drug is administered, the microneedle array penetrates into the inner wall of the blood vessel, and the drug is injected into the blood vessel tissue by pressure to achieve the purpose of drug administration; moreover, the microneedle array is wide in distribution and large in area, so that the injection distribution of the drug is more uniform, the treatment is more effective, and restenosis can be better prevented; finally, the double-drug administration balloon 1 can also be used as a drug injection device, and corresponding drugs can be injected into the vessel wall according to clinical requirements.
The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the scope of the present invention, therefore, the present invention is not limited by the appended claims.
Claims (10)
1. The utility model provides a two medicines sacculus of dosing, includes the sacculus body and the connecting pipe that link to each other, its characterized in that, the sacculus body includes first sacculus, cover and locates second sacculus in the first sacculus and connect in both with the sacculus tip of one end, first sacculus the looks interval between the second sacculus and form first injection channel, the second sacculus is hollow structure and its inside first pressure release passageway that fills that forms, the surface of first sacculus is equipped with first micropin array, the surface of second sacculus is equipped with second micropin array, second micropin array with first micropin array dislocation set, first sacculus is used for carrying first medicine, first injection channel is used for carrying the second medicine.
2. The dual drug administration balloon of claim 1, wherein the connection tube comprises an outer tube and an inner tube having a hollow structure, the outer tube is provided with a second injection channel and a second pressure-releasing channel, which are isolated from each other, the second injection channel is communicated with the first injection channel and used for delivering the second drug, the second pressure-releasing channel is communicated with the first pressure-releasing channel and used for pressure-releasing, and the inner tube is inserted into the second pressure-releasing channel, the first pressure-releasing channel, the balloon tip and the inner portion thereof to form a guide wire cavity.
3. The dual-drug administration balloon of claim 1, wherein a hydrophilic coating is disposed on a surface of the first balloon, the hydrophilic coating is provided with a plurality of concave holes, the concave holes are filled with the first drug, a plurality of first microneedles included in the first microneedle array protrude from the hydrophilic coating, and a plurality of second microneedles included in the second microneedle array correspond to the concave holes respectively.
4. The dual drug delivery balloon of claim 3, whereinThe concave holes are distributed at 4-8/mm2And the minimum distance between two adjacent concave holes is 0.08-0.25 mm.
5. The dual-drug delivery balloon of claim 3, wherein the first microneedle and the second microneedle are both molded from a high molecular polymer or a metal material, and are fixed by glue, an adhesive or welding; and the first microneedle has a height of 0.10-1.0mm, the second microneedle has a height of 0.50-1.5mm, and the second microneedle is longer than the first microneedle.
6. The dual-drug delivery balloon of claim 3 or 5, wherein the balloon body has a folded state in which the first microneedles are wrapped inside a surface of the first balloon and an expanded state in which the first microneedles are wrapped inside a surface of the second balloon, and in which the first microneedles protrude from a surface of the first balloon and the second microneedles protrude from a surface of the second balloon.
7. The dual drug delivery balloon according to claim 6, wherein in the folded state, the portion of the first balloon to which the first microneedles are fixed is depressed inward to form a first depression such that an end of the first microneedle is lower than a surface thereof in a radial direction of the first balloon, and the portion of the second balloon to which the second microneedles are fixed is depressed inward to form a second depression such that an end of the second microneedle is lower than a surface thereof in the radial direction of the second balloon; after the folded state is converted into the expanded state, the first sunken part is radially expanded outwards along the first balloon to enable the first microneedles to be protruded out of the surface of the first balloon, and the second sunken part is radially expanded outwards along the second balloon to enable the second microneedles to be protruded out of the surface of the second balloon.
8. The dual drug delivery balloon of claim 6, wherein the first balloon is a non-compliant balloon and the second balloon is a semi-compliant balloon or a compliant balloon, such that the second balloon can continue to expand in a pressurized state to pass the second microneedles through the first balloon.
9. The dual drug administration balloon of claim 2, wherein the outer tube defines an opening communicating with the second pressure and pressure charging and discharging channel, the inner tube is disposed through the second pressure and pressure charging and discharging channel, the first pressure and pressure charging and discharging channel and the balloon tip via the opening, and the inner tube further defines a developing ring thereon.
10. The dual drug delivery balloon of claim 2, further comprising a base, wherein the base is hermetically connected to an end of the connecting tube away from the balloon body and has a first channel and a second channel isolated from each other, and the first channel and the second channel are respectively communicated with the second injection channel and the second pressure-filling/releasing channel.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111305196.1A CN114010917A (en) | 2021-11-05 | 2021-11-05 | Double-medicine administration balloon |
| CN202222756380.4U CN219440371U (en) | 2021-11-05 | 2022-10-19 | Double-drug administration saccule |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202111305196.1A CN114010917A (en) | 2021-11-05 | 2021-11-05 | Double-medicine administration balloon |
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| CN114010917A true CN114010917A (en) | 2022-02-08 |
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| CN202111305196.1A Pending CN114010917A (en) | 2021-11-05 | 2021-11-05 | Double-medicine administration balloon |
| CN202222756380.4U Active CN219440371U (en) | 2021-11-05 | 2022-10-19 | Double-drug administration saccule |
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| CN202222756380.4U Active CN219440371U (en) | 2021-11-05 | 2022-10-19 | Double-drug administration saccule |
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| CN114470341A (en) * | 2022-03-02 | 2022-05-13 | 南京鼓楼医院 | Composite microneedle balloon and preparation method thereof |
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| CN219440371U (en) | 2023-08-01 |
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