Catheter system and method of use for forming human tissue scaffolds

Abstract

The present invention relates to a catheter system for forming a human tissue scaffold and a method of using the catheter system, comprising a catheter distal tip, a distal balloon, an intermediate balloon, a proximal balloon, a catheter middle section, and a tube seat; the catheter distal tip and the tube seat are located at both ends of the catheter; the distal balloon, the intermediate balloon, the proximal balloon, and the catheter middle section are sequentially located between the distal tip and the tube seat; the balloon is provided with a plurality of developing rings; the tube seat comprises a plurality of joints; the present invention can reach a target position through a conventional interventional surgical method via a guide guidewire, temporarily block a diseased segment through a blocking catheter system composed of blocking balloons at the proximal and distal ends, and perform directional suction and drug administration on the diseased segment; shape the diseased segment through expansion of the intermediate balloon catheter, and simultaneously open ultraviolet light to activate drugs in the diseased segment through optical fibers, so that a human tissue scaffold is formed in the blood vessel wall, recanalization is achieved, and finally the purpose of treating vascular stenosis is achieved, thus truly realizing the concept of interventional non-implantation treatment.

Description

Technical Field

[0001] The present invention relates to a human tissue scaffold, and in particular to a catheter system and a method of use for forming a human tissue scaffold. Background Art

[0002] Vascular stenosis refers to the abnormal lipid metabolism in the human body's arteriovenous vessels, including the coronary, peripheral, and intracranial blood vessels. The lipids in the blood are deposited on the originally smooth vascular endothelium, gradually accumulating into atherosclerotic lipid plaques. Over time, these plaques increase and even calcify, causing stenosis in the vascular lumen, obstructing blood flow, leading to ischemia of downstream blood vessels and the body, and producing corresponding clinical manifestations. If the stenosis occurs in the coronary arteries, it will cause palpitations, chest pain, dyspnea, and angina pectoris. In severe cases, it will lead to myocardial insufficiency or myocardial necrosis; if it occurs in the periphery, it will cause a decrease in skin epidermal temperature, muscle atrophy, intermittent claudication, and even necrosis or amputation of distal limbs. If it occurs intracranial, it will cause dizziness, syncope, and even brain tissue damage and brain dysfunction.

[0003] With the development of vascular interventional technology, the technologies for treating vascular stenosis are becoming increasingly diverse. Commonly used treatment methods include balloon angioplasty, stent implantation, and the use of drug-eluting balloons.

[0004] (1) Balloon catheters are used in many surgical applications, including for balloon angioplasty, even including use at the distal or proximal end of the treatment site to block blood flow. During use, the inflation pressure of the balloon must be controlled to avoid over-expansion or rupture of the balloon, which may rupture or otherwise damage the blood vessel. Percutaneous transluminal angioplasty (PTA) has been widely used to treat atherosclerotic lesions, in which a balloon is used to open the blocked artery. However, this technology is limited by the thorny problems of re-occlusion and restenosis. Vascular restenosis is caused by excessive proliferation of smooth muscle cells (SMCs), and the restenosis rate exceeds 20%. Therefore, about one-fifth of patients who receive PTA treatment must be treated again within a few months, and some surveys even show that the stenosis rate within 12 months after PTA treatment exceeds 60%.

[0005] (2) Stent implantation is also a popular treatment method, which is generally performed through percutaneous intervention. First, a balloon catheter is used to reach the lesion site through a guide wire and pre-expand it, and then the stent is implanted into the blood vessel lumen to support the blood vessel wall and restore blood flow. However, after the stent is implanted, it will affect the contraction of the artery or further cause occlusion, and the stent itself may be the main factor causing complications. It has been found that 20% to 30% of patients require postoperative treatment after the implantation of metal stents. One of the reasons for this high frequency of treatment after surgery is that despite the implantation of vascular stents, vascular intimal hyperplasia in the vascular lumen still causes the lumen to narrow. In order to reduce in-stent restenosis, attempts have been made to design a type of stent with a surface-loaded restenosis-inhibiting drug so that when the stent is implanted in the artery, the drug is eluted in the stent and released into the vascular lumen in a controlled manner.

[0006] These attempts have led to the commercialization of drug-eluting stents (hereinafter referred to as DES) using sirolimus (immunosuppressant, also known as rapamycin) and taxane (cytotoxic antitumor drug). However, since these drugs inhibit the proliferation of vascular cells (endothelial cells and smooth muscle cells) by acting on the cell cycle, they can inhibit the hyperplasia of the vascular intima caused by excessive proliferation of smooth muscle cells. However, once the drug is shed during the implantation of the stent, the proliferation of endothelial cells at the shed site is also inhibited, resulting in adverse effects and a reduction in the repair or treatment effect of the lesion segment vascular intima. At the same time, considering the fact that thrombosis tends to occur more easily in areas of the vascular intima that are less covered by endothelial cells, antithrombotic drugs must be administered for a long time, such as about half a year. Even if antithrombotic drugs are taken, the drugs will be exhausted and there is a risk of causing late thrombosis and restenosis.

[0007] There are also some disclosed surgical intervention methods. For example, in Chinese patent CN112472967A, a mechanical plug-in self-locking balloon three-way handle and a balloon catheter system using the same are disclosed, including: a three-way balloon handle with one port used as a first connection end; a locking device including a locking tube and an elastic block arranged in the locking tube, an axial through hole is left between the elastic block and the locking tube, a locking nut for connecting the first connection end to the locking tube is sleeved on the front end of the locking tube, a guide rail gradually approaching the axis of the locking tube from back to front, a rack arranged along the guide rail and a locking assembly cooperating with the guide rail sliding guide is provided at the rear part of the locking tube, and a locking button that can mesh with the rack is provided on the locking assembly; when the locking assembly is pushed forward along the guide rail, the locking assembly squeezes the elastic block in the radial direction of the through hole, thereby locking and fixing the guide wire passing through the through hole, and when the locking assembly is located at the rear end of the guide rail, the guide wire can move axially back and forth in the through hole. The mechanical plug-in self-locking balloon three-way handle of the present invention has a simple structure, can lock the guide wire, is convenient for connecting the guide wire with the balloon handle, and is convenient for locking the balloon catheter and the guide wire during clinical use.

[0008] China CN 112138263A discloses a visualized three-level sinus balloon dilatation and irrigation catheter system, the catheter system includes: a catheter assembly, a guide assembly, a visualized shooting assembly and a handle assembly, the first end of the catheter assembly passes through the handle assembly and is embedded in the guide assembly, and the second end of the catheter assembly is exposed to the handle assembly setting; the catheter assembly includes a connecting tube and a three-level balloon arranged on the connecting tube; the first end of the guide assembly is detachably connected to the handle assembly, and the second end of the guide assembly is exposed to the handle assembly setting; the visualized shooting assembly is detachably connected to the catheter assembly; the guide assembly includes a guide catheter, and the end of the guide catheter is also provided with a bending portion, and the bending portion is made of a flexible material. This application can integrate visualization function, guide function, balloon dilatation and irrigation function, imaging function, and three balloons of different diameters into one, which is simple, convenient and effective, and reduces the operation time.

[0009] Although the technical features disclosed in the above patents effectively solve the technical problems they address, help patients reduce discomfort during surgery, and speed up the doctor's work. However, in the above applications and through consulting relevant literature, there is little disclosure of the catheter system of the human tissue stent. The above two patent applications belong to the field of medical device technology, which is an interventional operating device outside the human body, such as the medical equipment required for common minimally invasive surgery. As for the internal parts of the human body, such as blood vessels and other internal tissues, the interventional treatment methods required for lesions are currently relatively scarce. The commonly used stent implantation method, although it reduces the damage to a very low level, still has hidden dangers for the later pathological changes of the human body; for example, in some chemotherapy processes, patients need to endure a painful process, and the process of lesions also has uncontrollable changes, which will cause further damage to the human body, so it is also a complicated observation process for doctors.

[0010] Therefore, how to overcome the limitations of existing technologies, effectively treat vascular stenosis, maintain long-term patency while causing minimal damage to the human body and not implanting foreign substances, and achieve true intervention without implantation is an urgent issue that needs to be resolved and is of great significance. Summary of the invention

[0011] In view of this, an object of the present application is to provide a catheter system and a method of use for forming a human tissue scaffold.

[0012] In order to achieve the above objectives, this application provides the following technical solutions:

[0013] A catheter system for forming a human tissue stent, the system uses conventional interventional surgery, which refers to some procedures such as stent implantation and surgery, which require conventional access to start intervention or treatment, but the difference from the prior art is that the technical means adopted by this application after intervention and the operation of the catheter system used in the human body can achieve the treatment effect without actually implanting a stent. The system reaches the target vascular stenosis lesion through a guide wire, and temporarily blocks the lesion segment through a blocking catheter system composed of proximal and distal blocking balloons, and performs directional suction and drug administration on the lesion segment;

[0014] The system comprises a catheter mid-section, a proximal balloon, a distal balloon and a light-transmissive intermediate balloon;

[0015] The catheter middle section extends from the proximal end to the distal end, the distal balloon is positioned at the most distal end of the catheter middle section, the proximal balloon is positioned at the relatively proximal end of the catheter middle section, the proximal end of the distal balloon, and the intermediate balloon is positioned between the proximal balloon and the distal balloon;

[0016] There are multiple cavities in the middle section of the catheter, which provide filling channels for each balloon body, provide channels for drug injection and suction for the catheter system, and also serve as channels for the insertion or introduction of optical fibers.

[0017] Preferably, the diameter of the middle section of the catheter is between 2 and 16 Fr (Fr stands for French, 3 Fr = 1 mm).

[0018] The proximal balloon and the distal balloon may be expanded to 2 to 10 mm, and in some embodiments, may also be 3 to 5 mm, and the length may be 1 to 3 cm;

[0019] Preferably, the proximal balloon and the distal balloon are compliant or semi-compliant balloons;

[0020] Preferably, the proximal balloon and the distal balloon can seal the middle section of the blood vessel, and their shapes can be determined as needed, and can be rectangular, spherical, elliptical, rugby-shaped or any other symmetrical or asymmetrical shape;

[0021] The diameter of the intermediate balloon may be 2 to 10 mm, and in some embodiments, may also be 2 to 4 cm, and the length may be 0.5 to 5 cm.

[0022] Preferably, the shape of the middle balloon can be any shape, such as cylindrical, chocolate-shaped, etc.

[0023] Preferably, the intermediate balloon is a compliant or semi-compliant balloon.

[0024] Preferably, the middle balloon is transparent or translucent.

[0025] Preferably, the material of the intermediate balloon may be polyurethane, nylon, Pebax, polyester resin (PET), polyolefin, or any other flexible and light-transmitting material.

[0026] Preferably, the optical fiber can mainly transmit ultraviolet light with a wavelength of 350 to 500 nm, preferably 450 nm.

[0027] Preferably, the therapeutic agent used in the catheter system of the present disclosure includes any one or a combination of several drugs in gas, liquid, suspension, emulsion or solid form, which can be for therapeutic or diagnostic purposes.

[0028] Preferably, the therapeutic drug may include a biologically active substance or a substance capable of inducing 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 factor), viral vectors, DNA capable of expressing proteins, sustained-release polymers, and unmodified or modified cells; the therapeutic drug may include angiogenic drugs that induce the formation of new blood vessels; the therapeutic drug may also include anti-stenosis agents or anti-restenosis agents for treating vascular wall narrowing. The therapeutic drug may also include photoactivators, such as photoactivated anti-stenosis agents or photoactivated anti-restenosis agents that can be used to treat vascular wall narrowing.

[0029] Optionally, the catheter system is equipped with a pressure sensor to monitor the pressure in the blood vessel in real time.

[0030] The advantages and effects of this application are as follows:

[0031] (1) The present invention discloses a catheter system and a method of use for forming a human tissue scaffold, wherein the middle section of the catheter is a catheter containing 7 lumens, wherein the first lumen is a lumen through which a guide wire passes, the second lumen is a filling and retraction lumen for an intermediate balloon, the third lumen and the fourth lumen are respectively filling and retraction lumens for a distal balloon and a proximal balloon, and the fifth lumen and the sixth lumen are respectively therapeutic agent injection and suction channels connected to ports on both sides of the intermediate balloon. These five ports are important components of the entire catheter system, and are organically connected to the seven connectors, which greatly reduces the time for delivering drugs during treatment, reduces the painful process endured by patients, and greatly improves the effect of drugs; it also enables doctors to propose treatment plans more targeted, greatly improving the doctor's operational capabilities.

[0032] (2) The present invention relates to a catheter system for forming a human tissue scaffold, which includes an optical fiber, including a connector, a light-proof section, a light-transmitting section, and an intermediate balloon distal developing ring and an intermediate balloon proximal developing ring located at both ends of the light-transmitting section; the optical fiber is light-transmitting in the light-transmitting section of the catheter, and the other positions are made of or coated with light-proof materials to avoid energy loss in unnecessary positions during the light-guiding process. The light-transmitting section improves visualization during treatment and makes treatment of the lesion location clearer. The present invention allows for more targeted and efficient treatment of vascular stenosis lesions.

[0033] (3) The present invention uses conventional interventional surgery to reach the target vascular stenosis lesion through a guide wire. However, unlike the prior art, there is no need to actually implant a stent. Instead, during the operation, a blocking catheter system composed of proximal and distal blocking balloons is used to temporarily block the lesion segment, and targeted suction and drug administration are performed on the lesion segment for a period of time to allow the drug to fully penetrate into the vessel wall, thereby suctioning excess drug, and shaping the lesion segment through the expansion of the intermediate balloon catheter. At the same time, ultraviolet light is turned on in the lesion segment through optical fiber to activate the drug, so that a human tissue scaffold is formed in the vessel wall to achieve recanalization, and ultimately achieve the purpose of treating vascular stenosis. This reduces the burden on both doctors and patients during the treatment process, reduces the patient's pain time, improves the treatment effect, and enhances the pertinence and efficiency of the doctor's treatment plan.

[0034] (4) The present invention provides a solution for the treatment of vascular stenosis through vascular access. Through the technology of ultraviolet light-activated drugs, a human tissue scaffold similar to a "scaffold" is created inside the blood vessel, thereby avoiding some disadvantages of the existing technology, that is, the disadvantages caused by simple balloons, such as restenosis, occlusion and other problems. It also provides a long-term solution for many patients who need stent implantation without stent implantation, truly realizing the concept of interventional non-implantation treatment.

[0035] (5) The present invention provides controlled delivery and suction of therapeutic drugs, and activates drugs through ultraviolet light to shape the blood vessels into the final expanded shape. It optimizes the problems of traditional vascular interventional surgery, such as the need to build stents, delayed drug administration, or recurrence of lesions at the treatment site, and the inability to change the treatment plan in time, and provides doctors with a more convenient means. The multiple cavities built into the middle section of the catheter and the multiple connectors on the tube seat realize the simultaneous supply of drugs and the extraction of excess drugs, achieving a more effective absorption treatment of the drugs at the lesion site, thereby providing more targeted and efficient treatment for vascular stenosis lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings without creative work. In all drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, each element or part is not necessarily drawn according to the actual scale.

[0037] Figure 1 is a schematic diagram of an exemplary embodiment of a catheter system for forming a human tissue scaffold;

[0038] Figure 2a to Figure 2c A schematic diagram of the distal end of the catheter system when it is working;

[0039] Figure 3 is a cross-sectional view of a catheter shaft in certain embodiments;

[0040] Figure 4 A schematic diagram of an optical fiber used in conjunction with a catheter system in certain embodiments;

[0041] The reference numerals are as follows: 1. distal tip of catheter; 2. distal balloon; 3. intermediate balloon; 4. proximal balloon; 5. middle section of catheter; 6. tube seat; 7. distal balloon developing ring; 8. first port; 9a. distal developing ring of intermediate balloon; 9b. proximal developing ring of intermediate balloon; 10. second port; 11. transparent section of catheter; 12. proximal balloon developing ring; 13. third port; 14. fourth port; 15. fifth port; 17. first connector; 18. second connector; 19. third connector; 20. fourth Connector; 21, fifth connector; 22, sixth connector; 24, guide wire; 25, lesion location; 2a, distal balloon; 3a, intermediate balloon; 4a, proximal balloon; 6a, first lumen; 17a, second lumen; 18, third lumen; 19a, fourth lumen; 20a, fifth lumen; 21a, sixth lumen; 22a, seventh lumen; 23, optical fiber; 24, connector; 25, opaque section; 26, translucent section; 27a, proximal developing ring of intermediate balloon; 27b, distal developing ring of intermediate balloon. DETAILED DESCRIPTION

[0042] To make the purpose, technical scheme and advantages of the embodiment of the present application clearer, the technical scheme in the embodiment of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiment of the present application. Obviously, the described embodiment is a part of the embodiment of the present application, rather than all of the embodiments. In the following description, specific details such as specific configuration and components are provided only to help fully understand the embodiments of the present application. Therefore, it should be clear to those skilled in the art that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present application. In addition, for clarity and brevity, the description of known functions and structures is omitted in the embodiment.

[0043] It should be understood that the references to "one embodiment" or "this embodiment" throughout the specification mean that the specific features, structures, or characteristics associated with the embodiment are included in at least one embodiment of the present application. Therefore, the references to "one embodiment" or "this embodiment" appearing throughout the specification do not necessarily refer to the same embodiment. In addition, these specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0044] In addition, the present application may repeat reference numerals and / or letters in different examples. This repetition is for the purpose of simplicity and clarity, and does not in itself indicate the relationship between the various embodiments and / or settings discussed.

[0045] The term "and / or" in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can mean: A exists alone, B exists alone, and A and B exist at the same time. The term " / and" in this article describes another type of association object relationship, indicating that there can be two relationships. For example, A / and B can mean: A exists alone, and A and B exist alone. In addition, the character " / " in this article generally indicates that the previous and next associated objects are in an "or" relationship.

[0046] The term "at least one" in this article is merely a description of the association relationship of associated objects, indicating that there may be three relationships. For example, at least one of A and B can mean: A exists alone, A and B exist at the same time, and B exists alone.

[0047] It should also be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusions.

[0048] Example 1

[0049] This embodiment introduces a catheter system and a method of use for forming a human tissue scaffold.

[0050] A catheter system for forming a human tissue scaffold provided in an embodiment of the present application comprises: a catheter distal tip 1, a distal balloon 2, an intermediate balloon 3, a proximal balloon 4, a catheter shaft 5, an intermediate balloon distal developing ring 9a and an intermediate balloon proximal developing ring 9b, a distal balloon developing ring 7, a proximal balloon developing ring 12, and a tube seat 6;

[0051] It also includes 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 that are symmetrically distributed with the pipe seat 6 as the axis;

[0052] Furthermore, the intermediate joint 16 is connected with the distal tip 1 of the catheter, and is a passage for the guide wire when entering the human body;

[0053] Furthermore, the first connector 17 is connected to the first port 10 in the intermediate balloon 3, and is a passage for the intermediate balloon 3 to be filled and retracted;

[0054] Furthermore, the second connector 18 and the fifth connector 21 are connected to the fourth port 14 and the fifth port 15 respectively, and are used as channels for infusing drugs and suctioning the lesion segment during treatment;

[0055] Furthermore, the third connector 19 and the third port 13 in the proximal balloon 4 are connected to provide a filling and suction channel for the proximal balloon 4;

[0056] Furthermore, the fourth connector 20 is connected to the first port 8 in the distal balloon 2, providing a filling and suction channel for the distal balloon 2;

[0057] Furthermore, the sixth joint 22 passes through the middle section 5 of the catheter to the inside of the intermediate balloon 3, and the optical fiber 23 is connected to the 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 intermediate balloon 3 (between the distal developing ring 9a and the proximal developing ring 9b);

[0058] Furthermore, the catheter middle section extends from the proximal end to the distal end, the distal balloon is positioned at the distal end of the catheter shaft, the proximal balloon is positioned at the relatively proximal end of the catheter shaft, the proximal end of the distal balloon, and the intermediate balloon is positioned between the proximal balloon and the distal balloon.

[0059] It is worth noting that the occluding catheter system composed of the proximal and distal occluding balloons temporarily occludes the lesion segment, performs targeted suction and drug administration to the lesion segment and maintains this for a period of time, allowing the drug to fully penetrate into the blood vessel wall.

[0060] Optionally, the shapes of the first port 8 , the second port 10 , the third port 14 , the fourth port 15 and the fifth port 13 in the catheter system may be elliptical, circular, rectangular, square, triangular or any other shapes.

[0061] Optionally, the multiple ports can be located on the same side of the catheter shaft, on the opposite side, or at a certain angle to each other, such as 90 degrees, 60 degrees, etc., and the circumferential positions of the ports on the catheter shaft can be interchangeable.

[0062] like Figure 4 As shown, it shows the optical fiber used in conjunction, which includes a connector 24, a light-proof section 25, a light-transmitting section 26, a proximal developing ring 27a of the middle balloon, and a distal developing ring 27b of the middle balloon. Only the light-transmitting section 26 of the optical fiber is light-transmitting, and the other positions are made of or coated with light-proof materials to avoid energy loss in unnecessary positions during the light-guiding process. When the optical fiber enters the catheter system along the cavity, the light-transmitting section 26 of the optical fiber is exactly located at the transparent position in the middle balloon of the catheter system. The optical fiber is connected to the light source through the connector 24 to guide the light.

[0063] Optionally, the optical fiber may not be built into the catheter system, but enters the catheter system through the sixth connector 22 during the treatment process to reach the designated position.

[0064] Furthermore, the optical fiber can mainly transmit ultraviolet light with a wavelength of 350 to 500 nm, preferably 450 nm.

[0065] Through the technology of ultraviolet light-activated drugs, a human tissue scaffold similar to a scaffold is created inside the blood vessel, avoiding the disadvantages of existing technologies caused by simple balloons, such as restenosis and occlusion. It also provides a solution for many patients who need stent implantation to maintain long-term patency without the need for stent implantation.

[0066] Example 2

[0067] Based on the above-mentioned catheter system for forming a human tissue scaffold, this embodiment further describes a method for using the catheter system for forming a human tissue scaffold. The specific steps are as follows:

[0068] Please refer to Figure 1 , Figure 2a , Figure 2b , Figure 2c , Figure 3 , Figure 4 .

[0069] Step 1: Use the guide wire 24 to enter the human blood vessel through a specific access route to reach the designated vascular stenosis lesion location 25 to be treated, so that the middle balloon 3a in the contracted state spans the lesion segment, and the distal balloon 2a and the proximal balloon 4a in the contracted state are located on both sides of the lesion segment 25. At this time, the distal end of the catheter system is shown in FIG. Figure 2a as shown in .

[0070] Step 2: The proximal balloon 4 and the distal balloon 2 are filled through the third connector 19 and the fourth connector 20 respectively. At this time, the proximal balloon 4b and the distal balloon 2b in the filled state block the two ends of the blood vessel, and the lesion position 25 is blocked from the normal position to form a closed blood vessel space. At this time, the distal end of the catheter system is shown in FIG. Figure 2b as shown in .

[0071] Step 3: The blood in the blocked lesion position is sucked through the distal fourth port 14 and the proximal fifth port 15 by connecting the second connector 18 and the fifth connector 21;

[0072] Furthermore, a therapeutic agent is injected into the blocked lesion site through the second connector 18 and the fifth connector 21, and the pressure is maintained for a period of time, so that the therapeutic agent fully penetrates into the blood vessel wall in the lesion site 25;

[0073] Preferably, the pressure holding time may be 30 seconds to 10 minutes. After the therapeutic agent has fully penetrated, the excess therapeutic agent at the lesion site of the blocked blood vessel is sucked out through the second connector 18 and the fifth connector 21 .

[0074] Step 4: Fill the intermediate balloon 3a in the contracted state through the first joint 17 and the second port 10 of the intermediate balloon, so that the intermediate balloon is in the filled state 3b, and pressurizes it to a certain pressure.

[0075] Preferably, 4 to 30 atm may be used to pressurize and expand the lesion site 25 and maintain the pressure for a period of time to ensure that the lesion site is expanded to the expanded state 25a.

[0076] Further, the ultraviolet light is turned on, and the ultraviolet light is transmitted from the transparent section 11 of the middle balloon 3 through the optical fiber to act on the lesion position 25a where the therapeutic agent has penetrated. At this time, the distal end of the catheter system is shown in FIG. Figure 2c as shown in .

[0077] It is noteworthy that ultraviolet light activates the therapeutic agent, which causes the therapeutic agent to produce a human tissue scaffold within the human blood vessel wall, thereby producing a support effect similar to that of an implanted stent, resisting the problem of restenosis after the catheter system is retracted.

[0078] Optionally, the ultraviolet light activation process can be maintained for 30 to 120 seconds. Finally, through the normal interventional surgery process, each balloon body is retracted and the catheter system is withdrawn from the human body along the guide wire 24.

[0079] Through the operation steps of this embodiment, the practicality of the catheter system is further specified. On the basis of conventional interventional methods, the lesion is entered, and then non-implantation treatment is achieved through the catheter system of this application, and finally the purpose of treating vascular stenosis is achieved, avoiding some disadvantages of the prior art, that is, the disadvantages caused by a simple balloon, such as restenosis, occlusion and other problems, and also providing a solution for many patients who need stent implantation to maintain long-term patency without stent implantation.

[0080] Example 3

[0081] Based on Example 2, the method for using the catheter system for forming a human tissue scaffold is further supplemented.

[0082] like Figure 3The cross-sectional view of the middle section 5 of the catheter is shown in the figure, wherein the middle section 5 of the catheter is a catheter comprising 7 lumens, wherein the first lumen 6a is the lumen through which the guide wire passes; the second lumen 17a is the filling and retraction lumen of the intermediate balloon; the fourth lumen 19a and the fifth lumen 20a are the filling and retraction lumens of the distal balloon 2 and the proximal balloon 4, respectively; the third lumen 18a and the sixth lumen 21a are respectively therapeutic agent injection and suction channels connected to the ports on both sides of the intermediate balloon 3; the seventh lumen 22a can be provided with an optical fiber 23, or a lumen can be reserved.

[0083] The optical fiber is introduced in an interventional manner during the treatment process.

[0084] Optionally, the optical fiber 23 may not be arranged in the seventh cavity 22a, and during the treatment process, the optical fiber is introduced from the first cavity 6a by means of rapid exchange.

[0085] Optionally, a pressure sensor may be disposed in the seventh lumen 22a to monitor the intraluminal pressure of the blood vessel during the entire treatment process.

[0086] Optionally, except for the first cavity 6a, the cross-sectional shapes of other cavities can be adjusted to any shape as needed.

[0087] The optical fiber used in conjunction with the embodiment of the present invention is Figure 4 It is composed of a connector 24, a light-proof section 25, a light-transmitting section 26, a middle balloon proximal end developing ring 27a and a middle balloon distal end developing ring 27b.

[0088] Only the light-transmitting section 26 of the optical fiber is light-transmitting, and the other positions are made of or coated with opaque materials to avoid energy loss at unnecessary positions during the light guiding process.

[0089] When the optical fiber enters the catheter system along the cavity, the light-transmitting section 26 of the optical fiber is just located at the transparent position in the middle balloon of the catheter system. The optical fiber is connected to the light source through the connector 24, thereby guiding light.

[0090] Through the technology of ultraviolet light-activated drugs, a human tissue scaffold similar to a scaffold is created inside the blood vessel, thus avoiding some drawbacks of existing technologies, namely the drawbacks caused by simple balloons. It also provides many patients who need stent implants with a solution that can maintain long-term normal life without the need for stent implants, truly realizing the concept of interventional non-implantation treatment.

[0091] The above description is only the preferred embodiment of the present invention, which does not limit the protection scope of the present invention. For those skilled in the art, the present invention can be modified and varied in various ways. Within the spirit and principle of the present invention, any change, modification, replacement, integration and parameter change of these embodiments by conventional substitution or capable of achieving the same function without departing from the principle and spirit of the present invention shall fall within the protection scope of the present invention.

Claims

1. A catheter system for forming a human tissue scaffold, characterized in that: The system comprises a distal tip of a catheter, a distal balloon, an intermediate balloon, a proximal balloon, a middle section of a catheter, a tube seat, and an optical fiber; The distal tip and the tube seat of the catheter are located at both ends of the catheter; the distal balloon, the middle balloon, the proximal balloon, and the middle section of the catheter are located in sequence between the distal tip and the tube seat of the catheter, and the middle balloon has a transparent section of the catheter; The balloon is provided with a plurality of developing rings, and the distal balloon, the middle balloon, and the proximal balloon are all provided with developing rings; the tube seat includes a plurality of joints; The optical fiber comprises a connector, a light-proof section, a light-transmitting section, and a distal developing ring of the intermediate balloon and a proximal developing ring of the intermediate balloon located at both ends of the light-transmitting section. The optical fiber is introduced in an interventional manner. When the optical fiber enters the catheter system along the cavity, the light-transmitting section of the optical fiber is located exactly at the transparent section of the catheter in the intermediate balloon of the catheter system. The catheter system also includes a first port located above the developing ring of the distal balloon, a second port located above the developing ring of the proximal end of the intermediate balloon, a third port located between the distal balloon and the intermediate balloon, a fourth port located between the intermediate balloon and the proximal balloon, a fifth port located above the developing ring of the proximal balloon, a first joint, a second joint, a third joint, a fourth joint, a fifth joint, a sixth joint and an intermediate joint symmetrically distributed with the tube seat as the axis; The intermediate joint is connected to the distal tip of the catheter; The first connector is connected to the second port in the middle balloon, providing a channel for the filling and deflation of the middle balloon; The second connector and the fifth connector are connected to the fourth port and the fifth port respectively; The third connector is connected to the third port in the proximal balloon; The fourth connector is connected to the first port in the distal balloon; The sixth connector reaches the interior of the intermediate balloon through the catheter shaft.

2. A catheter system for forming a human tissue scaffold according to claim 1, characterized in that: The middle section of the catheter is a catheter comprising 7 lumens, wherein the first lumen is a lumen through which the guidewire passes; the second lumen is a filling and retraction lumen for the middle balloon; the fourth lumen and the fifth lumen are respectively the filling and retraction lumens for the distal balloon and the proximal balloon; the third lumen and the sixth lumen are respectively therapeutic agent injection and suction channels connected to the ports on both sides of the middle balloon; the seventh lumen is arranged with an optical fiber or serves as a reserved lumen, and the lumen built into the middle section of the catheter is organically connected to the connectors distributed on the tube seat.

3. A catheter system for forming a human tissue scaffold according to claim 1, characterized in that: The shapes of the first port, the second port, the third port, the fourth port and the fifth port in the catheter system are elliptical, circular, rectangular, square and triangular.

4. A catheter system for forming a human tissue scaffold according to claim 1, characterized in that: The first to fifth ports in the catheter system are interchangeable in circumferential position on the catheter shaft; The first to fifth ports are located on the same side of the catheter shaft, on opposite sides, or at a certain angle to each other.

5. A catheter system for forming a human tissue scaffold according to claim 1, characterized in that: The optical fiber is connected to an external ultraviolet light generating device via a sixth connector.

6. A catheter system for forming a human tissue scaffold according to claim 5, characterized in that: The optical fiber is light-transmissive in the light-transmitting section of the catheter, and is made of or coated with opaque materials in other locations to avoid energy loss in unnecessary locations during the light-guiding process; The optical fiber is connected to the light source through a connector to guide the light.

7. A catheter system for forming a human tissue scaffold according to claim 1, characterized in that: The catheter system is equipped with a pressure sensor to monitor the intraluminal pressure of the blood vessels during the entire treatment process.

Images