CN117643678B

CN117643678B - A hollow balloon and related systems and methods

Info

Publication number: CN117643678B
Application number: CN202410114383.9A
Authority: CN
Inventors: 李虎; 侯江东
Original assignee: Shanghai Hope Medical Devices Co ltd
Current assignee: Shanghai Hope Medical Devices Co ltd
Priority date: 2024-01-29
Filing date: 2024-01-29
Publication date: 2024-12-03
Anticipated expiration: 2044-01-29
Also published as: CN117643678A

Abstract

The invention relates to a hollow balloon, which comprises a balloon assembly and a catheter assembly, wherein the balloon assembly comprises a balloon body, the balloon body comprises sub-balloons, a compliant ring and a containing port, all the sub-balloons and the compliant ring are sequentially connected with each other, all the sub-balloons and the compliant ring are coaxially arranged, so that the inner hollow structures of all the sub-balloons and the compliant ring form a fluid channel together, the catheter assembly comprises a connecting pipe, a traction rope, a through pipe and a joint, the distal ends of the traction rope and the connecting pipe are arranged at the proximal end of the balloon body and are arranged in a circumferential cross manner with the containing port together, the proximal ends of the traction rope and the connecting pipe are gathered together and are connected with the distal end of the through pipe, the proximal end of the through pipe is connected with the joint, and the catheter assembly is provided with a liquid injection channel which is communicated with all the sub-balloons. When the hollow balloon is applied, the drug coating on the surface of the balloon component is continuously absorbed by the blood vessel wall, and meanwhile, the balloon component can also support the blood vessel wall for a long time so as to avoid acute rebound and acute interlayer of the vessel wall.

Description

Hollow balloon and related systems and methods

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a hollow balloon.

Background

Peripheral vascular disease (PERIPHERAL VASCULAR DISEASES, PVD), classified according to anatomical location, generally refers to arterial, venous diseases other than coronary arteries, heart valves, intracranial vessels, such as the aorta and its branches, the arteriovenous of the extremities, the vena cava, the portal system, etc. The peripheral vascular disease category mainly includes stenosis occlusive disease, dilatation disease and dysplasia. For patients with middle and later-stage stenosis occlusive lesions, the intervention treatment in the cavity is usually needed to be obviously improved, and currently, the main interventional products for treating the vessel stenosis comprise a drug eluting stent, a bioabsorbable stent, a drug eluting balloon and the like.

Drug-eluting stents (DES) are a type of stent in which a bare stent is coated with a number of drug-binding drug-carrying polymers that have anticoagulant and/or antihistaminic cell proliferation, which are released by local elution in the vessel, to prevent restenosis in the stent. Compared with a simple balloon expansion and a metal bare stent, the DES can remarkably reduce the occurrence of restenosis in the stent. However, since such stents are permanently implanted stents, inflammatory and hypersensitivity reactions at the implantation site may be caused as the stent is left in the blood vessel for a longer period of time. The medicines (such as rapamycin, taxol, etc.) carried on the stent inhibit smooth muscle cell proliferation, and delay the re-endothelialization of the damaged part of the blood vessel, so that the catastrophic late intrastent thrombosis can be caused.

The design of bioabsorbable stents (bioresorbable vascular scaffold, BVS) is primarily intended to provide temporary vascular support while gradually degrading and fully absorbing the stent into tissue after implantation at the stenosed site and release of the proliferative drug, so that the vascular structure may be restored to normal physiological conditions. The greatest advantage of such stents is that they leave no track in the body. Although a plurality of BVSs are approved to be marketed, the recently published long-term follow-up results are not satisfactory, and the main disadvantages are that besides the excessive research and development cost, foreign matter residues, restenosis in the stent and poor mechanical properties are included, so that the elastic retraction is serious and complications such as chronic inflammatory reaction can be caused. Therefore, the absorbable stent technology is not mature, and the long-term effect still needs to be further evaluated.

Drug eluting balloon (drug eluting balloon, DEB) refers to a balloon with some antiproliferative drug coated on the surface of a conventional balloon. The medicine on the surface of the saccule is contacted with the pathologic blood vessel transiently through the saccule expansion and is released into the blood vessel wall rapidly, so that the effect of inhibiting the proliferation of the blood vessel intima is achieved locally. Compared with DES, the DEB has the main advantages that ① DEB can enable medicines to be released into the artery wall more uniformly, ② has no polymer and metal residues, so that the incidence rate of inflammatory reaction and late thrombus is reduced, ③ obviously shortens the treatment time of duplex antiplatelet, and reduces the occurrence of related complications. Although DEB presents great promise for interventional procedures, there are also some drawbacks in that ① vessel walls rebound acutely. Because the duration of action of DEB on the vessel wall is usually 1-3 min, after the balloon is withdrawn, the framework support is lost, the acute rebound phenomenon of the vessel wall occurs, the stenosis can not be fully dilated to relieve the stenosis, the residual stenosis rate is usually higher than that of the stent, and the acute interlayer occurs at ②. Regardless of which balloon expansion may result in dissection or tearing of the vessel, DEB is more carefully used, particularly with respect to the main or dominant vessel. If no immediate findings are obtained after the formation of a vascular dissection or tear, the outcome of the procedure once an acute thrombus or vascular occlusion has occurred may be catastrophic.

Disclosure of Invention

The invention discloses a hollow balloon, which aims to solve some technical problems existing in the existing products.

The invention adopts the following technical scheme:

A hollow balloon, comprising:

The balloon assembly comprises a balloon body and a developing element, wherein the balloon body comprises a plurality of sub-balloons, a plurality of compliant rings and a plurality of containing openings, the sub-balloons are of hollow cylindrical structures, the compliant rings are of hollow annular structures and are provided with a plurality of through holes, all the sub-balloons and the compliant rings are sequentially connected with each other, all the sub-balloons and the compliant rings are coaxially arranged, so that the hollow structures of all the sub-balloons and all the compliant rings form a fluid channel of the balloon body together, the containing openings are arranged on the edge of the proximal end of the balloon body, and the outer surface of the balloon assembly is provided with a drug coating;

The catheter assembly comprises a connecting pipe, a plurality of traction ropes, a through pipe and a connector, wherein the distal end of the connecting pipe is arranged on the edge of the proximal end of the balloon body and is mutually connected and communicated with the balloon body, the proximal end of the connecting pipe is connected and communicated with the distal end of the through pipe, the distal end of each traction rope is arranged on the edge of the proximal end of the balloon body, the distal end of the connecting pipe and each connection point of the distal end of each traction rope are respectively arranged in a circumferential intersecting manner with the containing opening, the proximal end of each traction rope and the proximal end of the connecting pipe are gathered together and are connected with the distal end of the through pipe, the proximal end of the through pipe is connected with the connector, the catheter assembly is provided with a liquid injection channel which is communicated with the inner cavities of all the sub-balloons and the through holes on all the compliant rings, and the outer surface of the catheter assembly is provided with a drug coating.

In alternative embodiments, the drug coating of the outer surface of the balloon assembly and the catheter assembly includes, but is not limited to, at least one of paclitaxel, rapamycin.

In an alternative embodiment, the balloon assembly further comprises developing elements disposed at both ends of the balloon body for marking the position of the balloon assembly.

In an alternative embodiment, the balloon body is a tubular structure formed by connecting the distal end of a hollow cylinder circumferentially with the proximal end of a compliant ring, connecting the proximal end of the next hollow cylinder circumferentially with the distal end of the compliant ring, and sequentially connecting other compliant rings and hollow cylinders end to end, wherein each hollow cylinder forms one sub-balloon, each sub-balloon is further provided with an inner cavity, and all the inner cavities and all the through holes form a filling cavity together.

In an alternative embodiment, the compliant ring is a hollow annular structure, the through holes are positioned on the ring of the compliant ring, the opening directions of the through holes are consistent with the opening directions of the compliant ring, and the through holes are intersected or tangent with the ring of the compliant ring.

In an alternative embodiment, the number of through holes on each compliant ring is not less than 2.

In an alternative embodiment, the shape of the receiving opening is C-shaped, V-shaped, rectangular or square, and the number of the receiving openings is not less than 3.

In alternative embodiments, the materials of the balloon assembly and the catheter assembly include, but are not limited to, at least one of nylon (PA), polyether block polyamide (Pebax), polyurethane (PU), or polyethylene terephthalate (PET).

In an alternative embodiment, the outer diameter of the balloon body is 5-25 mm, the length of the balloon body is 10-200 mm, the cross-sectional diameter of the inner cavity of the sub-balloon is 0.5-2 mm, the cross-sectional diameter of the through hole is 0.5-2 mm, and the length of the through hole is 0.5-5 mm.

In an alternative embodiment, the diameter of each of the haulage ropes is not greater than the outer diameter of the connecting tube, which is not greater than the outer diameter of the tube, which is the same as the joint diameter, which is smaller than the fluid passage diameter.

In an alternative embodiment, the haulage rope is a solid bar structure, and the number of haulage ropes is not less than 2.

In an alternative embodiment, the number of the connection pipes is not less than 1.

In an alternative embodiment, a rubber plug is arranged in the connector, and the rubber plug is tightly combined with the inner cavity of the connector.

In an alternative embodiment, the diameter of each of the sub-balloons on the balloon assembly is the same, and as such, the diameter of each of the compliant rings is the same, i.e., the channel diameter is the same throughout the sections of the fluid channel that are formed.

In an alternative embodiment, the diameter of each of the sub-balloons on the balloon assembly is different, and as such, the diameter of each of the compliant rings is different, i.e., the channel diameter is different throughout the sections of the fluid channel that are formed.

In an alternative embodiment, the balloon body only comprises a plurality of sub-balloons, the balloon body is of a spiral structure formed by spirally encircling a long original balloon around a central axis, each spiral ring of the spiral structure forms one sub-balloon, all the sub-balloons are communicated with each other, the sub-balloons are of a hollow ring-shaped structure, and all the sub-balloons are coaxially arranged, so that inner rings of all the sub-balloons form the fluid flow channel of the balloon body together.

Compared with the prior art, the technical scheme adopted by the invention has the following advantages:

The hollow balloon comprises a balloon assembly and a catheter assembly, wherein the balloon assembly comprises a balloon body, the balloon body comprises sub-balloons, compliant rings and containing openings, all the sub-balloons and the compliant rings are sequentially connected with each other, all the sub-balloons and the compliant rings are coaxially arranged, so that fluid channels are formed by inner hollow structures of all the sub-balloons and the compliant rings, the catheter assembly comprises connecting pipes, traction ropes, through pipes and connectors, the distal ends of the traction ropes and the connecting pipes are arranged at the proximal ends of the balloon body and are arranged in a circumferential intersecting manner together with the containing openings, the proximal ends of the traction ropes and the connecting pipes are connected with the distal ends of the through pipes in a gathering manner, the proximal ends of the through pipes are connected with the connectors, and the catheter assembly is provided with a liquid injection channel which is communicated with all the sub-balloons. According to the technical scheme, when the hollow balloon is fed into the lesion blood vessel position and fully expanded by filling agent, the medicine coating on the balloon assembly can be fully and continuously absorbed by the blood vessel wall of the lesion part, meanwhile, the fluid channel allows blood to normally circulate through the fluid channel, the medicine coating on the surface of the catheter assembly can prevent thrombus from forming on the surface of the catheter assembly, and further, the balloon assembly can be placed at the lesion blood vessel position for a long time, so that the balloon assembly can continuously support the blood vessel wall for a long time, and the occurrence of acute rebound and acute interlayer of the blood vessel wall is avoided, and therefore, the occurrence of unnecessary complications is prevented while the treatment effect is improved.

Drawings

The following drawings are simple schematic diagrams, which are used to more clearly illustrate the technical solution of the embodiments of the present invention, and do not constitute undue limitations of the present invention. In the drawings:

FIG. 1 is a schematic view showing a partial structure of a hollow balloon according to embodiment 1 of the present invention when fully inflated;

FIG. 2 is an enlarged schematic view of a portion of FIG. 1 at A;

FIG. 3 is a schematic cross-sectional view of the balloon of FIG. 1 when fully inflated;

FIG. 4 is a partial schematic view of a hollow balloon compression assembly provided in one embodiment of example 1 of the present invention within a delivery device;

Fig. 5 is a schematic view of an application scenario of the hollow balloon shown in fig. 1;

FIG. 6 is a schematic illustration of an embodiment of the catheter assembly of the hollow balloon of FIG. 1 with the proximal portion secured outside the body;

FIG. 7 is a partial schematic view of a balloon recovery device provided in one embodiment of example 1 of the present invention;

FIG. 8 is a schematic flow chart of deployment and retrieval of a hollow balloon in a patient's vascular system provided in one embodiment of example 1 of the present invention;

FIG. 9 is a schematic view showing a partial structure of a hollow balloon according to an embodiment of the present invention in example 2;

Fig. 10 is a schematic cross-sectional view of the balloon of fig. 9 when fully inflated.

Reference numerals illustrate:

Balloon assembly 100, balloon body 110, sub-balloon 111, compliant ring 112, through hole 113, developing element 120, receiving port 130, filling lumen 140, fluid channel 150, catheter assembly 200, connector 210, rubber plug 211, tubing 220, infusion channel 221, connecting tube 230, pull cord 240, delivery device 300, tip head 310, delivery catheter 320, loading cannula 330, butterfly buckle 410, sterile dressing 420, retrieval device 500, outer tube 510, inner tube 520, receiving mesh 530, balloon assembly 100', balloon body 110', sub-balloon 111111', developing element 120', filling lumen 140', fluid channel 150', connecting tube 230', pull cord 240'.

Description of the embodiments

In order to make the objects, advantages and technical solutions of the present invention more apparent, the following detailed and complete description of the embodiments of the present invention will be given with reference to the accompanying drawings. The details of the present description may be modified or varied as necessary in light of the actual requirements without departing from the spirit of the invention. It should be noted that, in the description of the present invention, the drawings illustrate the basic concept of the present invention by way of illustration only, and only the components related to the present invention are shown in the schematic drawings, which are not drawn according to the number, shape and size of the components in actual implementation, and the number, shape and proportion of the components in actual implementation may be changed according to the needs. Furthermore, the various embodiments of the present disclosure each have one or more features, which does not mean that the inventors must implement all features in any one embodiment at the same time, or that only some or all of the features in different embodiments may be implemented separately. That is, one skilled in the art may selectively implement some or all of the features of any one embodiment of the disclosure or may selectively implement some or all of the features of a plurality of embodiments according to actual needs, thereby making the present invention more flexible in implementation.

In the description of the present invention, it is further noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. Unless specifically stated or limited otherwise, the terms "mounted," "connected," "coupled," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or both in an internal communication or an interactive relationship between two elements. As used herein, the term "distal" refers to the end of the medical device that first enters the patient during normal use, and "proximal" refers to the end that is proximal to the operator. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

The described embodiments of the invention are only some, but not all, embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Examples

The present embodiment 1 provides a hollow balloon to solve the problems in the prior art. Referring to fig. 1-7, in a preferred embodiment, a hollow balloon includes a balloon assembly 100 and a catheter assembly 200; the balloon assembly 100 comprises a balloon body 110 and a developing element 120, wherein the balloon body 110 comprises a plurality of sub-balloons 111, a plurality of flexible rings 112 and a plurality of receiving ports 130, the sub-balloons 111 are of hollow cylindrical structures, the flexible rings 112 are of hollow annular structures, a plurality of through holes 113 are formed in the flexible rings 112, all the sub-balloons 111 and the flexible rings 112 are sequentially connected with each other, all the sub-balloons 111 and the flexible rings 112 are coaxially arranged, so that the hollow structures of all the sub-balloons 111 and the flexible rings 112 form a fluid channel 150 of the balloon body 110 together, the fluid channel 150 axially penetrates the balloon body 110, the receiving ports 130 are formed on the proximal edge of the balloon body 110, the outer surface of the balloon assembly 100 is provided with a drug coating, the catheter assembly 200 comprises a connecting tube 230, a plurality of haulage ropes 240, a through tube 220 and a joint 210, the distal end of the connecting tube 230 is formed on the proximal edge of the balloon body 110, and the balloon body 110 are mutually connected and communicated, the proximal end of the haulage 230 is connected with the through tube 220, the inner hollow structures of all the sub-balloons 111 and the flexible rings 112 are coaxially arranged, the fluid channel 150 axially penetrates the balloon body 110, the receiving ports 130 are sequentially arranged on the proximal edge of the balloon body 110, the connecting tube assembly 200 is provided with the proximal end of the connecting tube 200, the connecting tube is connected with the drug coating is arranged on the proximal end of the connecting tube 200, and the catheter assembly is sequentially connected with the proximal end of the connecting tube 200, and the catheter assembly is sequentially connected with the proximal end of the connecting tube 220, and the catheter assembly is connected with the proximal end of the catheter tube 200.

Because the hollow balloon has a unique design structure and an innovative treatment concept, the hollow balloon is not only suitable for patients with restenosis in a stent and bleeding risks, but also suitable for patients in medium and large lesion blood vessels, such as Buddha syndrome patients, and fills the blank of interventional treatment of the medium and large lesion blood vessels by the common drug balloon.

In a preferred embodiment, the balloon body 110 is formed by stretching, blowing and extruding nylon (PA), polyether block polyamide (Pebax), polyurethane (PU) or polyethylene terephthalate (PET) on a specific die to form a hollow cylinder with an inner cavity, then placing the hollow cylinder on another specific die, performing annular extrusion bonding on a plurality of positions of the hollow cylinder, forming a through hole 113 by a cavity channel which is not extruded on the ring, forming a compliant ring 112 by the through hole 113 and the extruded and bonded part at one position, forming left and right sub-balloons 111 at two ends of the compliant ring 112 along the length direction of the cylinder at one annular extrusion bonding position, finally forming an integrated balloon body 110 with a plurality of sub-balloons 111 and a plurality of compliant rings 112 which are mutually communicated, forming a filling cavity 140 of the balloon body 110 by the inner cavity of the sub-balloon 111 and the through hole 113 on the compliant ring 112 together, and isolating the filling cavity 140 from the fluid channel 150. When the filling agent is injected into the balloon 110, the balloon 110 expands radially outward to conform the outer wall of the balloon 110 to the inner wall of the vessel.

Further, the relative positions of the sub-balloons 111 and the compliant rings 112 are arranged in such a manner that the sub-balloons 111-1 at the proximal end, the compliant rings 112-2, the compliant rings 112-n-1 at the distal end, the sub-balloons 111 are arranged in sequence, that is, the sub-balloons 111 and the compliant rings 112 are arranged in a crossed sequence, and if the number of sub-balloons 111 is n, the number of compliant rings 112 is n-1, that is, the number of compliant rings 112 is always 1 less than that of the sub-balloons 111.

Optionally, the lengths of each sub-balloon 111 may be consistent or different, the arrangement of each compliant ring 112 on the balloon body 110 may be equidistant or non-equidistant, the number of through holes 113 on the compliant ring 112 may be 1 or more, the through holes 113 are mutually communicated with the inner cavities of the connected sub-balloons 111, and other extrusion bonding parts except the through holes 113 on the compliant ring 112 are not communicated with the connected sub-balloons 111, that is, the filling agent can continuously fill the next sub-balloon 111 through the through holes 113 while filling the inner cavity of one sub-balloon 111;

Optionally, the diameters of each sub-balloon 111 on the balloon assembly 100 are the same, and as such, the diameters of each compliant ring 112 are the same, i.e., the diameters of the channels of the sections of the entire fluid channel 150 formed, and the diameters of each sub-balloon 111 on the balloon assembly 100 are different, and as such, the diameters of each compliant ring 112 are different, i.e., the diameters of the channels of the sections of the entire fluid channel 150 formed, and specifically, in actual design, the appropriate balloon 110 length and arrangement between the sub-balloons 111 and compliant rings 112 may be selected according to the imaging observation of the lesion site so as to enable the balloon to be sufficiently adhered to the vessel wall.

Further, a plurality of receiving openings 130 are formed at the edges of the sub-balloon 111 connected with the distal ends of the connecting tube 230 and the traction ropes 240, each receiving opening 130 is annularly arranged along the edges of the sub-balloon 111 at a certain interval, one traction rope 240 or one connecting tube 230 is connected between every two adjacent receiving openings 130, the receiving openings 130 are shaped like a C, a V, a rectangle or a square, the receiving openings 130 are a part of the edges of the near-terminal balloon 111, the receiving openings 130 can be formed by placing one end edge of the sub-balloon 111 on another specific die and performing annular extrusion bonding to remove redundant materials, thus forming hollow receiving openings 130, preferably, the number of the receiving openings 130 is 3 or more, the size of the receiving openings 130 can be adjusted according to the diameter size of the sub-balloon 111, for example, the diameter size of the sub-balloon 111 is larger, the receiving openings 130 are correspondingly larger, so that the sub-balloon 111 and the receiving openings 130 can be matched better, and the receiving openings 130 are used for avoiding the balloon 110 collapsing effect after the flat-end of the balloon 110 is designed, and the balloon is convenient to recover.

Further, in the balloon assembly 100, in addition to the balloon body 110, there is a developing element 120 made of an X-opaque material, and the developing elements 120 are disposed at two ends of the balloon body 110, so as to determine whether the balloon assembly 100 reaches a lesion position during use of the hollow balloon.

Optionally, the outer diameter of the balloon body 110 is 5-25 mm, the length of the balloon body 110 is 10-200 mm, the cross-sectional diameter of the inner cavity of the sub-balloon 111 is 0.5-2 mm, and the cross-sectional diameter of the through hole 113 is 0.5-2 mm. Specifically, since there are individual differences between patients, and the lesion sites thereof may have different shapes or sizes, the size and arrangement of the balloon body 110 may be selected according to actual situations.

In a preferred embodiment, catheter assembly 200 comprises a connection tube 230, a pull cord 240, a tube 220, and a fitting 210, wherein the connection tube 230, the pull cord 240, and the tube 220 are made of at least one material including, but not limited to, nylon (PA), polyether block polyamide (Pebax), polyurethane (PU), or polyethylene terephthalate (PET), the fitting 210 is made of an acrylonitrile-butadiene-styrene copolymer (ABS), and a rubber plug 211 within the fitting 210 is made of medical rubber.

Optionally, a hydrophilic coating (not shown) is further provided on the outer surface of catheter assembly 200, which can provide good hydrophilic and lubricious properties to the outer surface of catheter assembly 200, and can inhibit adsorption of cells and proteins by the surface, thereby reducing the resistance to relative sliding between the outer surface of catheter assembly 200 and the vessel wall and mating instrument.

Further, the connection tube 230 is a continuous hollow tube, the connection tube 230 is a part of the injection channel 221, the distal end of the connection tube 230 is connected to and communicates with the proximal end wall of the balloon body 110 along the circumferential direction of the balloon body 110, and is located between any two adjacent receiving ports 130 in detail, the proximal end of the connection tube 230 is connected to and communicates with the distal end of the through tube 220, the number of connection tubes 230 disposed on the balloon body 110 may be one or more, and the outer diameter of the connection tube 230 is not greater than the outer diameter of the through tube 220.

Further, the hauling ropes 240 are solid bar-shaped structures, the proximal ends of all the hauling ropes 240 are gathered together and are connected with the distal ends of the through pipe 220, the distal ends of all the hauling ropes 240 are connected with the proximal end wall of the balloon body 110 along the circumferential direction of the balloon body 110 and are orderly and alternately arranged with the receiving ports 130, the number of the hauling ropes 240 is 2 or more, the diameter of the hauling ropes 240 is not larger than the outer diameter of the connecting pipe 230, and the hauling ropes 240 mainly pull and guide the proximal end of the balloon body 110 to enter the recovery device 500 under the action of external force.

Further, the tube 220 is a hollow tube constituting a part of the liquid injection passage 221, like the connection tube 230, and the distal end of the tube 220 is connected to and communicates with the proximal end of the connection tube 230, the proximal end of the tube 220 is connected to the distal end of the joint 210, and the outer diameter of the tube 220 is the same as the diameter of the joint 210.

Further, the distal end of the connector 210 is connected to the proximal end of the tube 220, the port (not shown) of the connector 210 is a filling agent inlet and outlet, a rubber plug 211 is provided inside the connector 210, the rubber plug 211 is mainly used for completely closing the inner cavity of the connector 210 and completely isolating the filling agent channel 221 from the outside, so as to prevent the filling agent from accidentally flowing out of the port of the connector 210, the diameter of the connector 210 is smaller than that of the fluid channel 150, and the connector 210 is mainly used for piercing the needle end of the syringe filled with the filling agent from the port of the connector 210 into the filling agent channel 221, so that the filling agent can freely enter and exit the filling agent channel 221 through the syringe.

Optionally, the diameter of the liquid injection channel 221 is 0.4-3.6 mm, the outer diameter of the through pipe 220 is 0.8-4 mm, the outer diameter of the connecting pipe 230 is 0.6-3 mm, and the diameter of the hauling rope 240 is 0.05-2 mm.

Optionally, a drug coating is also provided on the outer surfaces of the balloon assembly 100 and catheter assembly 200, the primary function of the drug coating on the balloon assembly 100 being to inhibit vascular endothelial cells, smooth muscle cells and fibroblasts proliferation for the purpose of reducing restenosis after balloon dilation, while the primary function of the drug coating on the catheter assembly 200 is to prevent thrombosis on the outer surface of the catheter assembly 200 during the period of time that the catheter assembly 200 is left in the blood vessel. The coated medicine comprises at least one of paclitaxel and rapamycin, and excipient (carrier) comprises at least one of urea, iopromide, polysorbate, shellac, butyryl citrate tri-n-hexyl, acetyl tributyl citrate, magnesium stearate and esters.

In this example 1, the specific operation method of the hollow balloon described above is as follows (refer to fig. 8):

Referring to fig. 4, the balloon assembly 100 of the hollow balloon is partially compressed and assembled at the distal end of the delivery device 300, i.e., is constrained at the distal end of the delivery catheter 320 near the TIP head 310 end and is wrapped in the loading sheath 330. A venous vascular access is established according to standard interventional techniques, under the monitoring of a medical fluoroscope, the distal end of a guide sheath (not shown) is pushed through the venous vascular access to the target vascular site by a guide wire, then the TIP end of the delivery device 300 loaded with the hollow balloon is inserted into the guide sheath by the guide wire (at this time, the loading sheath 330 is retracted outside the body), and the distal end of the delivery catheter 320 is continued to push the distal end of the delivery catheter 320 carrying the balloon assembly 100 out of the distal end of the guide sheath to the lesion vascular site.

Filling agent is injected from the port of the connector 210 into the filling channel 221 and finally flows into the filling cavity 140 of the balloon body 110 through the injector, so that the balloon assembly 100 is filled and expanded in the radial direction, when the balloon assembly 100 is fully expanded, the drug coating on the outer surface of the balloon assembly 100 is contacted with the blood vessel wall of the lesion blood vessel, so that the drug coating is continuously absorbed by the blood vessel wall, and simultaneously, the blood is allowed to normally pass through the fluid channel 150 in the balloon assembly 100 (refer to fig. 5, which is a schematic diagram of the treatment application scene of the hollow balloon), namely, the hollow balloon can continuously treat the lesion blood vessel for a period of time without affecting the blood flow passing therethrough, and at the moment, the drug coating on the outer surface of the catheter assembly 200 can play a role in preventing the thrombus formation on the outer surface of the catheter assembly 200.

After the balloon assembly 100 is expanded and supported in the diseased vessel site, the other catheter or accessory is withdrawn, only the distal ends of the balloon assembly 100 and catheter assembly 200 are retained within the vessel, only the proximal end of the catheter assembly 200 is retained outside the body (see fig. 6), the tube 220 is secured adjacent the puncture site with the butterfly clip 410, the skin around the puncture site and the proximal end of the catheter assembly 200 are thoroughly sterilized, and then the skin around the puncture site and the proximal end of the catheter assembly 200 are all hermetically secured with the sterile dressing 420 for the fixation and isolation of airborne bacteria. Preferably, the duration of the hollow balloon for treating the blood vessel is 10-20 days (because the balloon assembly 100 is left in the blood vessel for a relatively long time, the problem that the conventional drug coated balloon in the market is only short for treating the diseased blood vessel and is easy to occur is avoided, such as the blood vessel interlayer, acute rebound of the vessel wall and the effect time of the drug on the vessel wall are too short, so that the curative effect is reduced), and in the treatment process, the care of the pipeline is paid attention to.

After the treatment is completed, the sterile dressing 420 and the butterfly button 410 are removed, at which time the proximal end of the catheter assembly 200 is considered to be an "introducer guidewire", i.e., the introducer sheath is passed through the proximal end of the catheter assembly 200 so that the distal end of the introducer sheath can reach the proximal end of the balloon assembly 100. Likewise, the retrieval device 500 (see FIG. 7) is passed through the proximal end of the catheter assembly 200 and the introducer sheath so that the distal end of the retrieval device 500 reaches the proximal end of the balloon assembly 100. The outer tube 510 on the retrieval device 500 is retrieved, the self-expanding receiving mesh 530 at the distal end portion of the inner tube 520 is expanded, the inflation fluid in the balloon body 110 is withdrawn from the body by a syringe through the port of the connector 210, the balloon assembly 100 is collapsed and separated from the vessel wall, the connector 210 is slowly pulled back so that the balloon assembly 100 is entirely within the receiving mesh 530 and the lumen of the inner tube 520. The inner tube 520 is then withdrawn entirely within the outer tube 510. The retrieval device 500 is subsequently withdrawn from the vessel, and wound care is finally obtained at the puncture site.

Examples

Referring to fig. 9, this embodiment provides a hollow balloon, which is compared with embodiment 1, and the method for performing the hollow balloon for treating a blood vessel is the same, and the adopted materials are the same, and the main part with differences is the structural part of the balloon body 110', and the structure and the forming manner of the balloon body 110' in this embodiment are described below:

In a preferred embodiment, the balloon body 110' only includes a plurality of sub-balloons 111', the balloon body 110' is a spiral structure formed by winding an elongated original balloon around a central axis in a spiral manner, each spiral ring of the spiral structure forms one sub-balloon 111', all sub-balloons 111' are communicated with each other, the sub-balloons 111' are hollow ring-shaped structures, all sub-balloons 111' are coaxially arranged, so that inner rings of all sub-balloons 111' form a fluid flow channel of the balloon body 110', and distal ends of all traction ropes 240' and connecting pipes 230' are arranged on a proximal end wall of the balloon body 110' together and are connected in a spaced arrangement along the circumferential direction of the balloon body 110 '.

And (3) performing hot blow molding on a section of balloon pipe on a balloon molding machine of a specific mold to form a part of the balloon pipe into a strip-shaped original balloon, reserving a section of balloon pipe at the proximal end as a connecting pipe 230', cutting off the rest balloon pipe at the distal end of the original balloon, performing heat shrinkage sealing on the notch of the original balloon pipe, spirally winding the original balloon around a central axis, and connecting the outer walls of two adjacent spiral rings by adopting an adhesive or other connecting modes to avoid free separation of the spiral structures.

Optionally, the outer diameter of the balloon body 110' is 5-25 mm, the length of the balloon body 110' is 10-200 mm, and the cross-sectional diameter of the inner cavity of the sub-balloon 111' is 0.5-2 mm.

Claims

1. A hollow balloon, comprising: a balloon assembly, wherein the balloon assembly comprises a balloon body and a developing element, wherein the balloon body comprises a plurality of sub-balloons, a plurality of flexible rings and a plurality of receiving ports; the sub-balloons are hollow cylindrical structures, the flexible rings are hollow annular structures, and the flexible rings are provided with a plurality of through holes; all the sub-balloons and the flexible rings are sequentially connected to each other, and all the sub-balloons and the flexible rings are coaxially arranged, so that the hollow structures of all the sub-balloons and all the flexible rings together constitute a fluid channel of the balloon body; the receiving port is arranged on the proximal edge of the balloon body; the outer surface of the balloon assembly is provided with a drug coating; the balloon assembly also includes a developing element, which is arranged at both ends of the balloon body and is used to mark the position of the balloon assembly; the balloon body is a tubular structure composed of a hollow cylinder with a proximal end of a flexible ring connected circumferentially at the distal end, and the proximal end of the next hollow cylinder connected circumferentially at the distal end of the flexible ring, and then other flexible rings and hollow cylinders are alternately connected end to end in sequence; each hollow cylinder constitutes a sub-balloon; each sub-balloon is also provided with an inner cavity, and all the inner cavities and all the through holes together constitute a filling cavity; and the filling cavity is isolated from the fluid channel;

A catheter assembly, the catheter assembly includes a connecting tube, a plurality of traction ropes, a through tube and a joint; the distal end of the connecting tube is arranged on the proximal edge of the balloon body, and is interconnected and communicated with the balloon body, and the proximal end of the connecting tube is connected and communicated with the distal end of the through tube; the distal end of each of the traction ropes is arranged on the proximal edge of the balloon body, so that the distal end of the connecting tube and each of the connection points of the distal end of each of the traction ropes are respectively arranged circumferentially cross-arranged with the receiving port in sequence, the proximal end of each of the traction ropes and the proximal end of the connecting tube are gathered together and connected to the distal end of the through tube, and the proximal end of the through tube is connected to the joint; an injection channel is provided on the catheter assembly, and the injection channel is communicated with the inner cavity of all the sub-balloons and the through holes on all the flexible rings; the outer surface of the catheter assembly is provided with a drug coating.

2 . The hollow balloon according to claim 1 , wherein the drug coating on the outer surfaces of the balloon component and the catheter component includes but is not limited to at least one of paclitaxel and rapamycin.

3. The hollow balloon according to claim 1 is characterized in that the flexible ring is a hollow annular structure, the through hole is located on the ring of the flexible ring, the opening direction of the through hole is consistent with the opening of the flexible ring, and the through hole intersects or is tangent to the ring of the flexible ring.

4. The hollow balloon according to claim 1 is characterized in that the number of the through holes on each of the flexible rings is not less than 2.

5. The hollow balloon according to claim 1 is characterized in that the shape of the receiving opening is C-shaped, V-shaped, rectangular or square, and the number of the receiving openings is not less than 3.

6. The hollow balloon according to claim 1 is characterized in that the material of the balloon component and the catheter component includes but is not limited to at least one of nylon (PA), polyether block polyamide (Pebax), polyurethane (PU) or polyethylene terephthalate (PET).

7. The hollow balloon according to claim 1 is characterized in that the outer diameter of the balloon body is 5 to 25 mm; the length of the balloon body is 10 to 200 mm; the cross-sectional diameter of the inner cavity of the sub-balloon is 0.5 to 2 mm; the cross-sectional diameter of the through hole is 0.5 to 2 mm; and the length of the through hole is 0.5 to 5 mm.

8. The hollow balloon according to claim 1 is characterized in that the diameter of each traction rope is not larger than the outer diameter of the connecting tube, the outer diameter of the connecting tube is not larger than the outer diameter of the through tube, the outer diameter of the through tube is the same as the diameter of the connector, and the diameter of the connector is smaller than the diameter of the fluid channel.

9. The hollow balloon according to claim 8 is characterized in that the traction rope is a solid strip structure, and the number of the traction ropes is not less than 2.

10. The hollow balloon according to claim 1, characterized in that the number of the connecting tubes is no less than one.

11. The hollow balloon according to claim 1 is characterized in that a rubber plug is provided in the joint, and the rubber plug is tightly combined with the inner cavity of the joint.

12. The hollow balloon according to claim 1 is characterized in that the diameter of each sub-balloon on the balloon assembly is the same, and similarly, the diameter of each flexible ring is the same, that is, the channel diameters of each section of the entire fluid channel are the same.

13. The hollow balloon according to claim 1 is characterized in that the diameter of each sub-balloon on the balloon assembly is different, and similarly, the diameter of each flexible ring is different, that is, the channel diameters of each section of the entire fluid channel are different.

14. The hollow balloon according to claim 1 is characterized in that the balloon body only includes a plurality of sub-balloons, and the balloon body is a spiral structure formed by a long original balloon spirally wound around a central axis, each spiral circle of the spiral structure constitutes a sub-balloon, and all the sub-balloons are interconnected; the sub-balloons are hollow ring-shaped structures, and all the sub-balloons are coaxially arranged, so that the inner circles of all the sub-balloons together constitute the fluid flow channel of the balloon body.