CN216571155U - Catheter system for forming a scaffold for human tissue - Google Patents

Abstract

The utility model relates to a catheter system for forming a human tissue scaffold, which comprises a catheter far-end tip, a far-end balloon, a middle balloon, a near-end balloon, a catheter middle section and a tube seat, wherein the catheter far-end tip is connected with the catheter middle section; the distal tip and the tube seat of the catheter are positioned at two ends of the catheter; the far-end balloon, the middle balloon, the near-end balloon and the middle section of the catheter are sequentially positioned between the far-end tip and the tube seat; the two ends of the middle saccule are provided with a middle saccule far-end developing ring and a middle saccule near-end developing ring; a far-end balloon developing ring is arranged in the far-end balloon; a proximal balloon developing ring is arranged in the proximal balloon. The application makes the angiostenosis more targeted and more efficient treatment, provides more convenient operation equipment for medical work, relieves the treatment pain period for patients, reduces the negative influence of the implanted support on the human body in the treatment, and realizes the interventional non-implantation treatment concept in the true sense.

Description

Catheter system for forming a scaffold for human tissue

Technical Field

The present invention relates to a human tissue scaffold, in particular a catheter system for forming a human tissue scaffold.

Background

The blood vessel stenosis refers to lipid plaques of atheroma gradually accumulated on an original smooth blood vessel intima due to abnormal lipid metabolism of human artery and vein blood vessels, enclosed coronary vessels, periphery, intracranial blood vessels and the like. Over time, these plaques become enlarged or even calcified to cause stenosis in the vessel lumen, which can impede blood flow, leading to ischemia of the downstream vessels and body, with corresponding clinical manifestations. If the stenosis occurs in coronary artery, palpitation, chest pain, dyspnea and angina can be caused, and serious patients can cause insufficient blood supply to cardiac muscle or cardiac muscle necrosis; if it occurs peripherally, a decrease in skin epidermal temperature, muscle atrophy, intermittent claudication and even necrosis or amputation of the distal limb may occur. If it occurs in the cranium, dizziness, syncope, brain tissue damage and brain dysfunction may occur.

With the development of vascular intervention techniques, techniques for stenotic lesions of blood vessels are diversified day by day, wherein common treatment methods include balloon angioplasty, stent implantation, and the use of drug balloons.

(1) Balloon catheters are used in many surgical applications, for balloon angioplasty, and even for use at the distal or proximal end of a site to be treated to occlude blood flow. During use, the inflation pressure of the balloon must be controlled to avoid over-inflation or rupture of the balloon, which may rupture or otherwise damage the vessel. Percutaneous Transluminal Angioplasty (PTA) has been widely used to treat atherosclerotic lesions, in which a balloon is used to open an obstructed artery. However, this technique is limited by the troublesome problems of reocclusion and restenosis. Vascular restenosis is caused by Smooth Muscle Cell (SMC) hyperproliferation, with restenosis rates exceeding 20%. Thus, about one fifth of patients receiving PTA treatment must receive treatment again within several months, and even surveys have shown that the rate of stenosis over 60% within 12 months receiving PTA treatment.

(2) Stenting is also a popular treatment, generally by way of percutaneous intervention, using a balloon catheter to reach the site of the lesion over a guide wire and pre-expand, and then implanting a stent within the vessel lumen to support the vessel wall and restore blood flow. However, the stent itself may cause a major complication, by affecting the constriction of the artery or further causing occlusion after implantation. It has been found that 20% to 30% of patients require post-operative treatment after implantation of a metal stent. One of the reasons for the need for such high frequency treatment post-operatively is that intimal hyperplasia within the vessel lumen can lead to a narrowing of the lumen despite the implantation of the stent. In order to reduce in-stent restenosis, attempts have been made to design a stent of the type having a surface bearing a restenosis-inhibiting drug such that when the stent is implanted in an artery, the drug elutes within the stent in a controlled manner and is released into the lumen of the vessel.

These attempts have led to the current preparation of two-dimensional molecular monolayers using sirolimus (immunosuppressant, also known as rapamycin) and taxus species, mainly by (1) "liquid phase immersion method"; (2) "vapor process"; commercialization of drug-eluting stents of alcohol (cytotoxic antitumor drug) (hereinafter referred to as DES) has been carried out. However, since these drugs act on the cell cycle and have the effect of inhibiting the proliferation of vascular cells (endothelial cells and smooth muscle cells), vascular intimal hyperplasia due to excessive proliferation of smooth muscle cells can be inhibited. However, once the drug is exfoliated during the implantation of the stent, the proliferation of endothelial cells at the site of exfoliation is also inhibited to cause adverse effects, and the repair or therapeutic effect of the intima of the diseased segment is reduced. Meanwhile, in view of the fact that thrombosis tends to occur more easily at a site of the intima of a blood vessel that is less covered with endothelial cells, an antithrombotic drug must be administered for a long time, for example, about half a year, and even if the antithrombotic drug is administered, the drug will be exhausted and risk causing late thrombosis and restenosis.

For example, chinese CN112472967A discloses a mechanical plug-in self-locking balloon three-way handle and a balloon catheter system using the same, which includes: one port of the three-way balloon handle is used as a first connecting end; the locking device comprises a locking pipe and an elastic block arranged in the locking pipe, wherein a through hole along the axial direction is reserved between the elastic block and the locking pipe, a locking nut used for connecting the first connecting end and the locking pipe is sleeved at the front end of the locking pipe, a guide rail gradually approaching the axis of the locking pipe from back to front, a rack arranged along the guide rail and a locking assembly in sliding guide fit with the guide rail are arranged at the rear part of the locking pipe, and a locking button capable of being meshed with the rack is arranged on the locking assembly; when the locking assembly is pushed forwards along the guide rail, the locking assembly extrudes the elastic block along the radial direction passing through the hole, then the guide wire passing through the hole is locked and fixed, and when the locking assembly is positioned at the rear end of the guide rail, the guide wire can move back and forth along the axial direction in the passing hole. The mechanical plug-in self-locking balloon three-way handle is simple in structure, the guide wire can be locked, the guide wire is conveniently connected with the balloon handle, and the balloon catheter and the guide wire are conveniently locked in clinical use.

China CN 112138263a discloses a visual three-stage sinus balloon dilatation irrigation catheter system, which comprises: the visual shooting device comprises a catheter component, a guide component, a visual shooting component and a handle component, wherein a first end of the catheter component penetrates through the handle component and is embedded in the guide component, and a second end of the catheter component is exposed out of the handle component; the catheter assembly comprises a connecting pipe and a three-stage balloon arranged on the connecting pipe; the first end of the guide assembly is detachably connected with the handle assembly, and the second end of the guide assembly is exposed out of the handle assembly; the visual shooting assembly is detachably connected to the catheter assembly; the guide assembly comprises a guide catheter, the end part of the guide catheter is also provided with a bending part, and the bending part is made of flexible materials. This application can be with visual function, the guide function, the function is washed in the sacculus expansion, and the formation of image function, the sacculus integration of three kinds of different diameters is as an organic whole, and is simple, convenient effective, reduces the operation time.

Although the technical characteristics disclosed in the above patent effectively solve the technical problems to which the patient is subjected, help the patient to relieve discomfort during the operation, and also accelerate the work of the doctor to be completed smoothly. However, the content of the catheter system for human tissue scaffolds is very little disclosed in the above-mentioned applications and by referring to the related documents, and the above-mentioned two Chinese patent applications belong to the technical field of medical instruments, such as medical instruments required for common minimally invasive surgery, which are an interventional operation device outside the human body. The intervention treatment mode needed by the pathological changes of the internal parts of the human body, such as blood vessels and other internal tissues, is relatively lacked at present, the patient needs to bear the painful process in the chemotherapy process, the pathological change process is uncontrollably changed, the human body can be injured again, and therefore, the intervention treatment mode is a complex observation process for doctors.

Therefore, how to overcome the limitations of the prior art and provide a more effective and targeted catheter system to treat the stenosis of the blood vessel, maintain the long-term patency rate, cause the minimum damage to the human body and no foreign substances are implanted, so that the intervention is not implanted in the true sense, and the catheter system is a matter to be urgently solved and has very important significance.

SUMMERY OF THE UTILITY MODEL

In view of the above, it is an object of the present application to provide a catheter system for forming a scaffold for human tissue.

In order to achieve the above purpose, the present application provides the following technical solutions:

a catheter system for forming a stent in a body tissue, the system being operated or treated by a conventional interventional procedure, such as a stenting procedure, a surgical procedure, or the like, which is initiated by a conventional access procedure, but different from the prior art, the present application adopts a technical means after the intervention and the operation of the catheter system in the body, so that the treatment effect can be achieved without actually implanting the stent. The system reaches the target angiostenosis lesion position through a guide wire, temporarily blocks a lesion section through a blocking catheter system consisting of a blocking saccule at the near end and the far end, and performs directional suction and administration on the lesion section;

the system comprises a catheter middle section 5, a near end balloon 4, a far end balloon 2 and a light-permeable middle balloon 3;

the middle catheter section 5 extends from the proximal end to the distal end, the distal balloon 2 is positioned at the outermost end of the middle catheter section 5, the proximal balloon 4 is positioned at the opposite proximal end of the middle catheter section 5 and the proximal end of the distal balloon 2, and the middle balloon is positioned between the proximal balloon 4 and the distal balloon 2;

a plurality of cavities are formed in the middle section 5 of the catheter, and filling channels are provided for balloon bodies of the balloons in the catheter system; providing a channel for drug injection and aspiration for the catheter system; meanwhile, the optical fiber is also used as an optical fiber placing or leading-in channel;

preferably, the diameter of the middle section of the catheter is 2-16 Fr (Fr full-name French, 3Fr =1 mm).

The proximal balloon 4 and the distal balloon 2 can be inflated to 2-10 mm, in some embodiments, 3-5 mm, and the length can be 1-3 cm;

preferably, the proximal balloon 4 and the distal balloon 2 are compliant or semi-compliant balloons;

preferably, the proximal balloon 4 and the distal balloon 2 can seal the middle section of the blood vessel, and the shapes of the two can be determined according to requirements, and can be rectangular, spherical, elliptical, rugby ball type or any other symmetrical or asymmetrical shapes;

the diameter of the middle saccule 3 can be 2-10 mm, and in some embodiments, the diameter can also be 2-4 cm, and the length is 0.5-5 cm.

Preferably, the shape of the intermediate balloon 3 may be any shape, such as cylindrical, chocolate-like, etc.

Preferably, the intermediate balloon 3 is a compliant or semi-compliant balloon.

Preferably, the intermediate balloon 3 is transparent or translucent.

Preferably, the material of the middle balloon 3 may be polyurethane, nylon, Pebax, polyester resin (PET), polyolefin, or any other flexible and light-transmitting material.

Preferably, the therapeutic agent for use in the catheter systems of the present disclosure comprises any one of a gas, liquid, suspension, emulsion or solid or a combination of several drugs, which may be for therapeutic or diagnostic purposes. Therapeutic agents may include biologically active substances or substances capable of eliciting a biological response, including but not limited to endogenous substances (growth factors or cytokines including but not limited to basic fibroblast growth factor, acidic fibroblast growth factor, vascular endothelial growth factor, angiogenic factors), viral vectors, DNA capable of expressing proteins, sustained release polymers, and unmodified or modified cells; the therapeutic agent may include an angiogenic agent that induces neovascularization; the therapeutic agent may also include an anti-stenosis or anti-restenosis agent for treating narrowing of the vessel wall. The therapeutic agents may also include photoactivators, such as photoactivated anti-stenosis agents or photoactivated anti-restenosis agents, etc., which may be used to treat vessel wall narrowing.

Optionally, the catheter system is provided with a pressure sensor, which can monitor the pressure in the blood vessel in real time.

The application has the advantages and effects as follows:

(1) the utility model discloses a catheter system for forming a human tissue stent, wherein the middle section of the catheter is a catheter comprising 7 cavitary tracts, the first cavitary tract is a cavitary tract through which a guide wire passes, the second cavitary tract is an inflation and retraction cavitary tract of a middle saccule, the third cavitary tract and the fourth cavitary tract are respectively an inflation and retraction cavitary tract of a far-end saccule and a near-end saccule, and the fifth cavitary tract and the sixth cavitary tract are respectively therapeutic agent injection and suction channels connected with ports on two sides of the middle saccule. The five ports are important components of the whole catheter system and are organically connected with the seven joints, so that the time for delivering the medicine in the treatment process is greatly shortened, the pain process endured by a patient is relieved, and the effect of the medicine is greatly improved; the doctor can also put forward a treatment scheme more pertinently, and the operation capability of the doctor is greatly improved.

(2) The utility model reaches the target angiostenosis lesion position through a guide wire in a conventional interventional operation mode, and is different from the prior art in that a stent does not need to be implanted, but the lesion section is temporarily blocked by a blocking catheter system consisting of a blocking balloon at the near end and the far end in the operation process, the directional suction and administration are carried out on the lesion section and the lesion section is maintained for a period of time, so that the medicine fully permeates into the vessel wall, the redundant medicine is further sucked, the lesion section is expanded and shaped through a middle balloon catheter, and meanwhile, the ultraviolet light is opened at the lesion section through the optical fiber to activate the medicine, so that a human tissue stent is formed in the vessel wall, the recanalization is achieved, and the purpose of treating the angiostenosis is finally realized; the burden of both the doctor and the patient is reduced in the treatment process, the pain time of the patient is shortened, the treatment effect is improved, and the pertinence and the high efficiency of the treatment scheme of the doctor are improved.

(3) The application provides a solution for the treatment of angiostenosis. Through the technique of ultraviolet activation medicine, a human tissue support similar to "scaffold" nature has been established to inside the blood vessel to some drawbacks of having avoided prior art, through the drawback that simple sacculus caused promptly, like restenosis, occlusion scheduling problem, also provide for a lot of patients that need the stent implantation and need not the unobstructed solution of stent implantation just can maintain the long-term, realized in the true sense and intervene no implantation treatment theory.

(4) The utility model relates to a catheter system for forming a human tissue scaffold, which comprises an optical fiber, a connector, an opaque section, a light-transmitting section, a middle balloon far-end developing ring and a middle balloon near-end developing ring, wherein the middle balloon far-end developing ring and the middle balloon near-end developing ring are positioned at two ends of the light-transmitting section; the optical fiber is transparent at the transparent section of the guide pipe, and other positions are made of or coated by opaque materials, so that energy is prevented from being lost at unnecessary positions in the light guide process. The developing and light transmitting section improves the visualization in the treatment process and makes the treatment aiming at the pathological change position more clear. The utility model has more targeted and more efficient treatment for the angiostenosis.

The foregoing description is only an overview of the technical solutions of the present application, so that the technical means of the present application can be more clearly understood and the present application can be implemented according to the content of the description, and in order to make the above and other objects, features and advantages of the present application more clearly understood, the following detailed description is made with reference to the preferred embodiments of the present application and the accompanying drawings.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.

FIG. 1 is a schematic view of an exemplary embodiment of a catheter system for forming a scaffold for human tissue according to the present invention;

FIGS. 2a to 2c are schematic views of the distal end of the catheter system in operation;

FIG. 3 is a cross-sectional view of a mid-section of a catheter in accordance with certain embodiments;

FIG. 4 is a schematic view of an optical fiber used with a catheter system in accordance with certain embodiments;

wherein the reference numbers are in sequence: 1. a catheter distal tip; 2. a distal balloon; 3. a medial balloon; 4. a proximal balloon; 5. a middle section of the conduit; 6. a tube holder; 7. a distal balloon developer ring; 8. a first port; 9a, a middle saccule far-end developing ring; 9b, a middle saccule near-end developing ring; 10. a second port; 11. a transparent section of conduit; 12. a proximal balloon developer ring; 13. a third port; 14. a fourth port; 15. a fifth port; 17. a first joint; 18. a second joint; 19. a third joint; 20. a fourth joint; 21. a fifth joint; 22. a sixth joint; 24. guiding a guide wire; 25. the location of the lesion; 2a, a distal balloon; 3a, a middle balloon; 4a, a proximal balloon; 6a, a first cavity channel; 17a, a second cavity; 18. a third channel; 19a, a fourth channel; 20a, a fifth channel; 21a, a sixth cavity; 22a, a seventh cavity; 23. an optical fiber; 24. a connector; 25. a light-tight section; 26. a light-transmitting section; 27a, a middle balloon proximal developing ring; 27b, a medial balloon distal visualization ring.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. In the following description, specific details such as specific configurations and components are provided only to help the embodiments of the present application be fully understood. Accordingly, it will be apparent to those skilled in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present application. In addition, descriptions of well-known functions and constructions are omitted in the embodiments for clarity and conciseness.

It should be appreciated that reference throughout this specification to "one embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrase "one embodiment" or "the present embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Further, the present application may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed.

The term "and/or" herein is merely an association describing an associated object, meaning that three relationships may exist, e.g., a and/or B, may mean: a exists alone, B exists alone, and A and B exist at the same time, and the term "/and" is used herein to describe another association object relationship, which means that two relationships may exist, for example, A/and B, may mean: a alone, and both a and B alone, and further, the character "/" in this document generally means that the former and latter associated objects are in an "or" relationship.

The term "at least one" herein is merely an association relationship describing an associated object, and means that there may be three relationships, for example, at least one of a and B, may mean: a exists alone, A and B exist simultaneously, and B exists alone.

It is further noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion.

Example 1

This example describes the composition and connection of a catheter system for forming a scaffold for human tissue.

Please refer to fig. 1 to 3.

The embodiment of the application provides a catheter system for forming a human tissue scaffold, which comprises: the catheter comprises a catheter distal tip 1, a distal balloon 2, a middle balloon 3, a proximal balloon 4, a catheter middle section 5, a middle balloon distal development ring 9a, a middle balloon proximal development ring 9b, a distal balloon development ring 7, a proximal balloon development ring 12 and a tube seat 6;

the connector also comprises a first joint 17, a second joint 18, a third joint 19, a fourth joint 20, a fifth joint 21, a sixth joint 22 and an intermediate joint 16 which are symmetrically distributed by taking the pipe seat 6 as an axis;

furthermore, the middle joint 16 is communicated with the distal tip 1 of the catheter and is a passage for guiding a guide wire when entering a human body;

further, a first connector 17 is communicated with the first port 8 in the middle balloon 3, and is a channel for filling and retracting the middle balloon 3;

further, the second connector 18 and the fifth connector 21 are respectively communicated with the fourth port 14 and the fifth port 15, and are channels for infusing medicine and sucking to a lesion section during the treatment process;

further, a third connector 19 is in communication with a third port 13 in the proximal balloon 4, providing an inflation and aspiration channel for the proximal balloon 4;

further, the fourth connector 20 is in communication with the first port 8 in the distal balloon 2, providing an inflation and aspiration channel for the distal balloon 2;

further, a sixth joint 22 passes through the middle section 5 of the catheter to the inside of the middle balloon 3, the optical fiber 23 is connected with an external ultraviolet light generating device through the sixth joint 22, and the light emitting section of the optical fiber 23 is at the middle transparent section 11 of the middle balloon 3 (between the far-end developing ring 9a and the near-end developing ring 9 b);

further, the catheter middle section extends from the proximal end to the distal end, the distal balloon is positioned at the distal-most end of the catheter middle section, the proximal balloon is positioned at the opposite proximal end of the catheter middle section, the proximal end of the distal balloon, and the middle balloon is positioned between the proximal balloon and the distal balloon.

It is worth noting that the occlusion catheter system composed of the occlusion balloons at the proximal end and the distal end can temporarily occlude the lesion section, and the lesion section is directionally sucked and administered and maintained for a period of time, so that the medicine can fully permeate into the vessel wall.

Alternatively, the shape of the first port 8, the second port 10, the third port 13, the fourth port 14 and the fifth port 15 in the catheter system may be oval, circular, rectangular, square, triangular or any other shape.

Alternatively, the ports may be located on the same side of the catheter shaft, on opposite sides, or at an angle to each other, such as 90 degrees, 60 degrees, etc., and the circumferential positions of the ports on the catheter shaft may be interchanged.

As shown in fig. 4, which shows the optical fiber in use, it includes a connector 24, an opaque section 25, a transparent section 26, a middle balloon proximal visualization ring 27a and a middle balloon distal visualization ring 27 b. Only the light-transmitting section 26 of the optical fiber is light-transmitting, and other positions of the optical fiber are made of or coated with light-proof materials, so that energy is prevented from being lost at unnecessary positions in the light guiding process. When the optical fiber enters the catheter system along the lumen, the light-transmissive section 26 of the optical fiber is located just inside the middle balloon of the catheter system in a transparent position. The optical fiber is connected to a light source through a connector 24, thereby conducting light.

Alternatively, the optical fiber may not be built into the catheter system, but may be routed through the hub 22 into the catheter system during treatment to reach the desired location.

Through the technology of ultraviolet activation medicine, a human tissue support similar to scaffold nature has been established to the inside at the blood vessel, has avoided the drawback that causes through simple sacculus among the prior art, like restenosis, occlusion scheduling problem, also provides the unobstructed solution that just can maintain the long-term for a lot of patients that need the support implantation need not the support implantation.

Example 2

This embodiment is based on the foregoing embodiment 1, and mainly provides a further supplement to the middle section 5 of the catheter in the catheter system.

As shown in fig. 3, the cross section of the middle section 5 of the catheter is a catheter comprising 7 lumens, wherein the first lumen 6a is a lumen through which a guide wire passes, the second lumen 17a is a filling and retracting lumen of the middle balloon, the fourth lumen 19a and the fifth lumen 20a are filling and retracting lumens of the distal balloon 2 and the proximal balloon 4, respectively, the third lumen 18a and the sixth lumen 21a are therapeutic agent injection and suction channels connected to ports on both sides of the middle balloon 3, respectively, and the seventh lumen 22a is provided with an optical fiber 23 or is a reserved lumen.

Further, it is moulding for the pathological change section through middle sacculus pipe expansion, opens ultraviolet activation medicine simultaneously through optic fibre 23 in the pathological change section for form human tissue support in the vascular wall, reach the rethread, finally realize the purpose of treatment angiostenosis.

Further, the seventh cavity 22a may be disposed with an optical fiber 23, or may reserve a cavity, and the optical fiber is introduced in an interventional manner during the treatment process.

Alternatively, the seventh tract 22a may be free of optical fibers 23, which are introduced from the first tract 6a during the treatment by means of rapid exchange.

Optionally, a pressure sensor may be provided in the seventh lumen 22a to monitor the pressure within the lumen of the blood vessel throughout the treatment.

Alternatively, the cross-sectional shapes of the channels other than the first channel 6a may be adjusted to any shape as necessary.

The embodiment further shows the middle catheter section 5 as a catheter channel, the five ports are important components of the whole catheter system and are organically connected with the seven joints, so that the simultaneous supply and extraction of the medicines are realized, the time for conveying the medicines in the treatment process is greatly reduced, the pain process endured by a patient is relieved, the absorption treatment of the medicines at the lesion with higher effect is realized, and the effect of the medicines is greatly improved; and doctors can also put forward a treatment scheme more pertinently, so that the angiostenosis is treated more pertinently and efficiently.

Example 3

This embodiment is based on the foregoing embodiments 1 and 2, and mainly describes the method of using the catheter system for forming a scaffold for human tissue.

From embodiment 1 to embodiment 2, the use method of the catheter system for forming the human tissue scaffold comprises the following specific steps:

the method comprises the following steps: the distal end of the catheter system is shown in fig. 2a when the middle balloon 3a in the contracted state crosses the lesion and the distal balloon 2a and the proximal balloon 4a in the contracted state are positioned on both sides of the lesion 25 by guiding the guide wire 24 through a specific access intervention into the body vessel to the designated stenotic lesion 25 to be treated.

Step two: the proximal balloon 4 and the distal balloon 2 are inflated by the third joint 19 and the fourth joint 20, respectively, and the inflated proximal balloon 4b and the distal balloon 2b block both ends of the blood vessel, so as to block the lesion site 25 from the normal state, thereby forming a closed blood vessel space, and the distal schematic view of the catheter system is shown in fig. 2 b.

Step three: communicating through the second connector 18 and the fifth connector 21 blood in the occluded site is aspirated through the distal port 14 and the proximal fifth port 15;

further, a therapeutic agent is injected into the blocked lesion site through the second joint 18 and the fifth joint 21, and is maintained for a period of time under a pressure such that the therapeutic agent sufficiently permeates into the vessel wall in the lesion site 25; the dwell time may be 30 seconds to 10 minutes.

Step four: the intermediate balloon 3a in its deflated state is inflated through the intermediate balloon second port 10 via the first connector 17 to bring the intermediate balloon into the inflated state 3b and pressurized to a certain pressure.

Preferably, the pressurized dilation of the lesion site 25 may be performed using 4-30 atm and dwell time to ensure that the lesion site is dilated to the dilated state 25 a.

Further, turning on the ultraviolet light, the ultraviolet light is transmitted through the optical fiber from the transparent section 11 of the middle balloon 3 to act on the lesion site 25a where the therapeutic agent permeates, and the distal end of the catheter system is schematically shown in fig. 2 c.

The ultraviolet light activates the therapeutic agent, so that the therapeutic agent generates a human tissue stent in the wall of the human blood vessel, thereby generating a supporting force effect similar to an implant stent and resisting the problem of restenosis after the catheter system is withdrawn. Optionally, the ultraviolet light activation process can be maintained for 30-120 seconds. Finally, through the normal interventional procedure, each balloon body is retracted and the catheter system is withdrawn from the body along the guide wire 24.

The operational scheme of this embodiment ends so far. The utility of the catheter system is further substantiated by the operation steps of the present embodiment. The catheter system can be used for entering a lesion on the basis of a conventional intervention mode, then realizing non-implantation treatment through the catheter system, and finally realizing the purpose of treating the vascular stenosis, thereby providing a solution for maintaining long-term patency without the need of implantation of a stent for a plurality of patients needing the implantation of the stent. Provides more convenient operation equipment for medical work, relieves the treatment pain period for patients, reduces the negative influence of the implanted bracket on the human body in treatment, and truly realizes the interventional non-implantation treatment concept.

The above description is only a preferred embodiment of the present invention, and it is not intended to limit the scope of the present invention, and various modifications and changes may be made by those skilled in the art. Variations, modifications, substitutions, integrations and parameter changes of the embodiments may be made without departing from the principle and spirit of the utility model, which may be within the spirit and principle of the utility model, by conventional substitution or may realize the same function.

Claims (9)

1. A catheter system for forming a human tissue scaffold, characterized in that the catheter system comprises a catheter distal tip (1), a distal balloon (2), a middle balloon (3), a proximal balloon (4), a catheter middle section (5), a tube seat (6);

the catheter distal tip (1) and the catheter seat (6) are positioned at two ends of the catheter; the far-end balloon (2), the middle balloon (3), the near-end balloon (4) and the catheter middle section (5) are sequentially positioned between the far-end tip (1) and the tube seat (6);

a middle balloon far-end developing ring (9 a) and a middle balloon near-end developing ring (9 b) are arranged at two ends of the middle balloon (3); a far-end balloon developing ring (7) is arranged in the far-end balloon (2); a near-end balloon developing ring (12) is arranged in the near-end balloon (4).

2. The catheter system for forming a human tissue scaffold according to claim 1, further comprising a first joint (17), a second joint (18), a third joint (19), a fourth joint (20), a fifth joint (21), a sixth joint (22) and an intermediate joint (16) symmetrically distributed with the hub (6) as an axis;

the middle joint (16) is communicated with the distal tip (1) of the catheter;

the first joint (17) is communicated with a first port (8) in the middle balloon (3) and provides a passage for the middle balloon (3) to be inflated and retracted;

the second joint (18) and the fifth joint (21) are respectively communicated with the fourth port (14) and the fifth port (15);

the third joint (19) is communicated with a third port (13) in the proximal balloon (4);

the fourth joint (20) is communicated with the first port (8) in the far balloon (2);

the sixth joint (22) reaches the interior of the middle balloon (3) through the middle catheter section (5).

3. The catheter system for forming a human tissue scaffold according to claim 1, wherein the middle catheter section (5) is a catheter comprising 7 lumens, wherein the first lumen (6 a) is a lumen through which a guide wire passes, the second lumen (17 a) is a filling and retracting lumen of the middle balloon, the fourth lumen (19 a) and the fifth lumen (20 a) are respectively a filling and retracting lumen of the distal balloon (2) and the proximal balloon (4), the third lumen (18 a) and the sixth lumen (21 a) are respectively a therapeutic agent injection and suction channel connected to ports on both sides of the middle balloon (3), and the seventh lumen (22 a) is provided with an optical fiber (23) or is a reserved lumen.

4. A catheter system for forming a human tissue scaffold according to claim 3, wherein the catheter further comprises a first port (8) disposed above the distal balloon visualization ring (7), a second port (10) above the middle balloon proximal visualization ring (9 b), a fourth port (14) between the distal balloon (2) and the middle balloon (3), a fifth port (15) between the middle balloon (3) and the proximal balloon (4), and a third port (13) above the proximal balloon visualization ring (12);

and a cavity channel arranged in the middle section (5) of the guide pipe is organically connected with joints distributed on the pipe seat (6).

5. The catheter system for forming a human tissue scaffold according to claim 4, wherein the first to fifth ports in the catheter system are interchangeable in circumferential position on the catheter shaft;

the first through fifth ports are located on the same side of the catheter shaft, on opposite sides, or at an angle to each other.

6. The catheter system for forming a human tissue scaffold according to claim 1, further comprising an optical fiber comprising a connector (24), a light-opaque section (25), a light-transmissive section (26), and a central balloon distal end visualization ring (9 a) and a central balloon proximal end visualization ring (9 b) at both ends of the light-transmissive section (26).

7. A catheter system for forming a human tissue scaffold according to claim 6, wherein said optical fibers are connected to an external UV light generating device by a sixth joint (22) and the light emitting section of the optical fibers (23) is at the intermediate transparent section (11) of the intermediate balloon (3).

8. The catheter system of claim 7, wherein the optical fibers are optically transparent at the optically transparent portion of the catheter and are made of or coated with an optically opaque material at other locations to prevent energy loss at unwanted locations during the optical guiding process.

9. The catheter system of claim 1, wherein the catheter system comprises a pressure sensor.

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