Metal medicine dilatation balloon without blocking blood flow

Abstract

A metal medicine expansion balloon without blocking blood flow comprises an adjustable inner conveying system and a screw-in type outer conveying system, the adjustable inner conveying system is formed by connecting a supporting balloon with an adjustable handle through an inner pushing rod, the screw-in type outer conveying system is arranged on the periphery of the adjustable inner conveying system, and the screw-in type outer conveying system is connected with the adjustable handle through an outer pushing rod. Comprising a covered stent, a drug coating film, a main body skeleton, an outer pushing rod and a screw-in valve, the drug coating film covers the main body skeleton through the covered stent, the near end of the covered stent is connected with the far end of the outer pushing rod, and the near end of the outer pushing rod is connected with the far end of the screw-in valve. The internal system and the external system work cooperatively, a multi-channel blood flow path is formed during expansion, intraoperative blood perfusion is kept, acute ischemia and thrombosis risks during the operation are reduced, the internal supporting balloon adopts a shape memory alloy weaving process, pressure feedback in the expansion process is more obvious, the adherence gap is smaller, the adherence process is conformal, and the system is more suitable for complex lesions; meanwhile, the cutting effect is achieved, and the expansion effect is effectively improved.

Description

TECHNICAL FIELD

[0001] The present application relates to a drug balloon, in particular to a metal drug expansion balloon for blood vessel intervention treatment without blocking blood flow, and belongs to the technical field of medical devices. BACKGROUND

[0002] At present, the expansion balloon mainly includes: ordinary expansion balloon (suitable for simple stenosis lesion, the balloon inflation expansion restores the lumen patency, simple operation, low cost, high restenosis rate after operation), drug coated balloon (the balloon surface is coated with anti-proliferative drugs, the drug is released to the blood vessel wall during expansion, and the intimal hyperplasia is inhibited), cutting balloon technology (the balloon surface has a micro knife, the calcified or fibrotic plaque is cut during expansion), shock wave balloon technology (uses shock wave energy to select and fragment deep calcified plaque), high pressure balloon technology (uses high blasting pressure material to handle elastic retraction of the blood vessel). The existing expansion balloon with high molecular material as the base material is inflated by inflation, the balloon exerts a circumferential force on the blood vessel, the plaque is deformed and torn, and then the blood flow is restored.

[0003] Chinese patent CN104922784A discloses a drug elution balloon, a first cavity and a second cavity are arranged in the inner catheter of the drug elution balloon, the first cavity is used for passing the guide wire, and the second cavity is used for passing the blood flow, but the design has defects, the second cavity is small in diameter, and it is difficult to achieve the effect of completely smooth blood flow, if the second cavity is designed to be too large in diameter, the diameter of the balloon catheter is increased too much, and the overall delivery of the balloon catheter is affected.

[0004] Chinese patent CN101947350A discloses a hollow balloon catheter, a hollow channel independent of the inner cavity of the catheter is arranged in the balloon inner cavity, so that the balloon does not completely block the blood vessel after expansion, but the balloon is perforated on the balloon body to form the hollow channel, which affects the use performance of the balloon and has the risk of low pressure resistance, and the processing is difficult.

[0005] Chinese patent CN103949003A discloses an expansion continuous flow balloon catheter, which comprises an inner catheter, an outer catheter, a balloon and a developing ring, the balloon is connected with the outer catheter and the inner catheter provided with the developing ring, the edge of the balloon is two or three petals, after the balloon is filled, one or three hollow channels are formed, the balloon does not completely block the blood vessel after expansion, and the blood flow is smooth. However, when the edge of the balloon is two petals, the inner catheter is arranged on one side of the balloon, which affects the overall delivery of the balloon catheter, when the edge of the balloon is three petals, due to the special processing technology of the balloon, the edge of the balloon has three gaps, which is not a complete circular structure, it is difficult to form overall coverage on the lesion position in the use process, and there is a risk of causing thrombosis.

[0006] Chinese patent CN107243109B discloses a balloon catheter which does not block blood flow, the balloon catheter comprises an inner catheter, an outer catheter and a balloon arranged on the outer catheter, a developing ring is mounted on the inner catheter, the inner catheter and the outer catheter are connected together, the balloon is divided into four lobes, the edge part of each lobe is connected to the catheter by welding or other means, a through hole is arranged at the connection between the balloon and the catheter, four hollow channels are formed after the balloon is inflated, and blood can flow normally through the four channels. The catheter is still a balloon made of traditional high polymer material, which has the risk of rupture.

[0007] The balloon dilatation catheter mentioned in the above patent is made of high polymer as the base material, and attempts to maintain blood flow by adding hollow channels, but still has problems such as limited channel diameter, complex processing, poor structural stability, etc. There are inherent operation risks when using traditional high polymer drug balloon dilatation catheters to treat vascular stenosis. The high polymer balloon has the risk of rupture due to material properties, and excessive expansion can cause intimal tear, with the risk of dissection, perforation, spasm, etc. SUMMARY

[0008] To solve the above technical problems, the technical solution is as follows: A metal drug expansion balloon which does not block blood flow, comprising an adjustable inner delivery system and a screw-in outer delivery system, the adjustable inner delivery system is composed of a support balloon connected to an adjustable handle through an inner push rod, the screw-in outer delivery system is arranged around the adjustable inner delivery system, the screw-in outer delivery system comprises a covered stent, a drug coating film, a main body framework, an outer push rod and a screw-in valve, the drug coating film is covered on the main body framework through the covered stent, the proximal end of the covered stent is connected to the distal end of the outer push rod, and the proximal end of the outer push rod is connected to the distal end of the screw-in valve.

[0009] Further, the adjustable inner delivery system is composed of a support balloon, an inner push rod and an adjustable handle connected in sequence from far to near, the distal end of the support balloon is provided with a delivery wire, and the delivery wire is connected to the adjustable handle by penetrating the support balloon and the inner push rod.

[0010] Further, the covered stent is arranged around the periphery of the support balloon.

[0011] Further, a pressure feedback module is arranged in the adjustable handle, and the pressure feedback module is composed of a micro pressure sensor and a wireless transmission device.

[0012] Further, a distal developing ring is arranged between the distal end of the delivery wire and the distal end of the support balloon.

[0013] Further, the support balloon is composed of memory alloy wires which are reciprocally crossed up and down.

[0014] Further, the covered stent is a spiral winding structure, and the drug slow-release microspheres are arranged in the spiral gap.

[0015] Further, the covered stent is a segmented covered structure formed by parallel connection of a plurality of axial metal wires, and the metal wires are covered with independent drug coating films.

[0016] Further, a proximal end developing ring is arranged between the proximal end of the covered stent and the distal end of the outer push rod.

[0017] Further, the proximal end developing ring is provided with a blood flow monitoring unit connected with a data line in the outer push rod.

[0018] Further, the main body framework is composed of axial arrangement of wire materials.

[0019] Compared with the prior art, the beneficial effects are as follows: The problems of the prior art, such as limited channel diameter of the balloon dilatation catheter not blocking blood flow, complex processing, poor structural stability and the like, are solved; the internal support balloon adopts a shape memory alloy weaving process, the pressure feedback in the expansion process is more obvious, the wall-adhesion gap is smaller, the wall-adhesion process is more adaptive, and the process is more adaptive to complex lesions; in the expansion process, the metal balloon is expanded by pressure, and the process can be controlled according to the blood vessel diameter and the patient's state; the internal and external systems work cooperatively, a multi-channel blood flow path is formed during expansion, blood flow perfusion is maintained during the operation, the risk of acute ischemia during the operation is reduced (including reducing the myocardial hypoxia time, reducing the release of damage markers such as postoperative myocardial enzyme elevation), and the risk of thrombosis is reduced; continuous blood flow flushing can reduce platelet aggregation after vascular wall injury, reduce the probability of thrombosis, and no long-term high-intensity anticoagulant therapy is required after the operation, which is suitable for patients with high risk of bleeding. The operation efficiency and safety are improved: the balloon position does not need to be frequently adjusted to restore blood flow, the operation time is shortened, and the risk of iatrogenic injury is reduced. Adapt to complex lesions: for severe calcification and long segment stenosis, the metal balloon has a cutting effect, which can improve the expansion effect and maintain stable blood flow, and avoid the failure of traditional balloon repeated blocking. It is beneficial to patient recovery: minimally invasive combined with blood flow maintenance can reduce tissue damage, and the patient recovers faster and stays in hospital for a shorter time. BRIEF DESCRIPTION OF DRAWINGS

[0020] The above and / or additional aspects and advantages of the present application will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings, in which: Figure 1 System expansion state overall structure schematic diagram; Figure 2 System contraction state overall structure schematic diagram; Figure 3 One embodiment of the adjustable internal conveying unit; Figure 4 An embodiment of the rotary outer delivery unit; Figure 5 First embodiment of the metal balloon braiding process formation approach: single and single one-one reciprocating stack; Figure 6 Second embodiment of the metal balloon braiding process formation approach: single and single two-one reciprocating stack; Figure 7 Third embodiment of the metal balloon braiding process formation approach: double and double one-one reciprocating stack; Figure 8 Fourth embodiment of the metal balloon braiding process formation approach: double and double two-one reciprocating stack; Figure 9 Fifth embodiment of the metal balloon braiding process formation approach: double and double two-two reciprocating stack; Figure 10 Detailed structure diagram of the metal balloon part; Figure 11 An embodiment of the covered stent; Figure 12 Another embodiment of the covered stent; In the drawings: 100, adjustable inner delivery unit, 110, delivery wire, 120, supporting balloon, 130, distal developing ring, 140, inner push rod, 150, adjustable handle, 160, pressure feedback module, 161, micro pressure sensor, 162, wireless transmission unit, 200, rotary outer delivery unit, 210, covered stent, 211, drug coating film, 211a, independent drug coating film, 212, main body framework, 212a, helically wound main body framework, 213, drug sustained-release microspheres, 214, segmented covered film structure, 220, developing ring, 230, outer push rod, 240, rotary valve. DETAILED DESCRIPTION

[0021] In order to enable persons skilled in the art to more clearly understand the above-mentioned objects, features and advantages of the present application, the present application will be further described in detail below in conjunction with the drawings and specific embodiments. It should be noted that the embodiments of the present application and the features in the embodiments can be combined with each other without conflict.

[0022] In the following description, many specific details are set forth in order to provide a thorough understanding of the present application, however, the present application can also be practiced in other ways different from those described herein, therefore, the scope of protection of the present application is not limited by the specific embodiments disclosed below. EMBODIMENT

[0023] As Figures 1-2As shown, a non-blocking metal drug-eluting balloon includes an adjustable internal delivery system 100 and a rotary external delivery system 200. The adjustable internal delivery system 100 consists of a support balloon 120 connected to an adjustable handle via an internal push rod 140. The rotary external delivery system 200 is located around the adjustable internal delivery system 100. The rotary external delivery system 200 includes a covered support 210, a drug-coated membrane 211, a main frame 212, an external push rod 230, and a rotary valve 240. The drug-coated membrane 211 covers the main frame 212 via the covered support 210. The proximal end of the covered support 210 is connected to the distal end of the external push rod 230, and the proximal end of the external push rod 230 is connected to the distal end of the rotary valve 240.

[0024] The treatment is performed by following these steps: A compressed metal drug-eluting balloon is delivered to the lesion site via a blood vessel; Rotate the advance valve to release the external delivery system and position the film-coating support; Adjust the adjustable handle to drive the support balloon to expand and push the covered stent to adhere to the blood vessel wall; The drug-coated membrane releases antiproliferative drugs, inhibiting endometrial hyperplasia; Remove the equipment. Example

[0025] like Figure 3 As shown, the adjustable internal delivery unit integrates a pressure feedback module 160, located inside the adjustable handle 150. This module includes a miniature pressure sensor 161 and a wireless transmission unit 162. During operation, the expansion pressure of the support balloon 120 is transmitted to an external display in real time, allowing the doctor to adjust the handle 150 based on the pressure curve, preventing vascular damage caused by over-expansion. Simultaneously, the system presets a safe pressure threshold; exceeding this threshold automatically triggers a handle locking mechanism. This design significantly improves controllability, making it particularly suitable for cases with thin vessel walls or severe elastic recoil. Example

[0026] like Figure 4 As shown, this embodiment adds a blood flow monitoring unit 250 to the spiral-type external delivery unit 200. The blood flow monitoring unit 250 is integrated at the proximal imaging ring 220 and uses an ultrasonic Doppler probe to monitor the blood flow velocity in the dilation area in real time, transmitting the data to an external device via a data cable within the external push rod 230. Physicians can dynamically adjust the dilation strategy based on the blood flow to ensure that the perfusion volume in the tube does not fall below the critical value. This design further reduces the risk of acute ischemia and is suitable for patients with heart failure or high-risk conditions. Example

[0027] like Figures 5-9The support balloon 120 provides radial support force for the whole covered stent 210 and makes the covered stent 210 adhere to the blood vessel by expansion of the internal support balloon 120. The support balloon 120 is formed by braiding process of shape memory alloy material, Figure 5 The braiding process is formed by reciprocating intersection of a plurality of single-strand memory alloy wires. In the adjacent two rows of braided materials, each wire in the first row only covers the corresponding first wire in the second row, forming a single-layer interlaced structure. The structure realizes the shaping of the support balloon through a single edge pressing action. Figure 6 The braiding process is formed by reciprocating intersection of a plurality of single-strand memory alloy wires. In the adjacent two rows of braided materials, each wire in the first row covers two adjacent wires in the second and third rows, forming a double-layer interlaced structure. The structure increases the coverage area to improve the strength of the support balloon. Figure 7 The braiding process is formed by reciprocating intersection of a plurality of single-strand memory alloy wires. In the adjacent two rows of braided materials, each wire in the first row only covers the corresponding first wire in the second row, forming a single-layer interlaced structure. The structure realizes the shaping of the support balloon through a single edge pressing action. Figure 8 The braiding process is formed by reciprocating intersection of a plurality of single-strand memory alloy wires. In the adjacent two rows of braided materials, each wire in the first row covers two adjacent wires in the second and third rows, forming a double-layer interlaced structure. The structure increases the coverage area to improve the strength of the support balloon. Figure 9 The braiding process is formed by reciprocating intersection of a plurality of single-strand memory alloy wires. In the adjacent two rows of braided materials, each wire in the first row only covers the corresponding first wire in the second row, forming a single-layer interlaced structure. The structure realizes the shaping of the support balloon through a single edge pressing action. Embodiment

[0028] As shown in the drawings, Figure 10 The main skeleton 212 of the covered stent 210 is formed by laser engraving of shape memory alloy pipe or axial laying of shape memory alloy wire. The axial ribs in the main skeleton 212 are used for covering and can ensure the unfolding of the drug coating film. Other structures are used to bind the support balloon 120 to prevent the wire from being exposed. The support balloon 120 of the covered stent 210 is fixed in the distal end marker ring together with the distal end of the covered stent 210. The internal support balloon 120 is controlled by the adjustable handle 150 to adjust the axial accumulation degree of the delivery wire 110, so as to provide radial support force for the whole covered stent 210. The covered stent 210 adheres to the blood vessel by expansion of the internal support balloon 120. At this time, the rotation valve 240 of the rotation type outer delivery unit 200 is in a free state. Embodiment

[0029] As shown in the drawings, Figure 11As shown, the covered stent 210 in this embodiment adopts a spirally wound main frame 212a, which is formed by spirally winding shape memory alloy wire or by laser cutting shape memory alloy tubing. Drug-releasing microspheres 213 are embedded in the spiral gaps. The microspheres 213 are triggered by pressure during stent expansion and release anti-proliferative drugs in stages. The spiral structure generates rotational force during expansion, which helps to cut calcified plaques, while the spiral channel forms a continuous blood flow path. This design is suitable for long calcified stenosis lesions, combining mechanical cutting and long-acting drug release functions, reducing the postoperative stenosis rate. Example

[0030] like Figure 12 As shown, the covered stent 210 in this embodiment is a segmented covered structure 214, which is composed of multiple axial metal wires connected in parallel. According to the structural design, each group of metal wires is covered with an independent drug-coated membrane 211a. During expansion, the support balloon 120 pushes the metal wires and the externally covered independent drug-coated membranes 211a to adhere to the wall segment by segment, which is more adaptable to the tortuous shape of the blood vessel. This design reduces the longitudinal stress of long stents, reduces the risk of vascular spasm, and is more suitable for tortuous blood vessels.

[0031] In the description of this specification, the terms "one embodiment," "some embodiments," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0032] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A non-blocking metal drug-eluting balloon, comprising an adjustable internal delivery system (100) and a rotary external delivery system (200), wherein the adjustable internal delivery system (100) is composed of a support balloon (120) connected to an adjustable handle via an internal push rod (140), characterized in that, The rotary external delivery system (200) is located around the adjustable internal delivery system (100). The rotary external delivery system (200) includes a film-covered support (210), a drug-coated film (211), a main frame (212), an external push rod (230), and a rotary valve (240). The drug-coated film (211) is covered on the main frame (212) by the film-covered support (210). The proximal end of the film-covered support (210) is connected to the distal end of the external push rod (230), and the proximal end of the external push rod (230) is connected to the distal end of the rotary valve (240).

2. The non-blocking blood flow metal drug-eluting balloon according to claim 1, characterized in that, The adjustable internal delivery system (100) is composed of a support balloon (120), an internal push rod (140) and an adjustable handle (150) connected in sequence from far to near. The support balloon (120) is provided with a delivery wire (110) at its far end. The delivery wire (110) passes through the support balloon (120) and the internal push rod (140) and is connected to the adjustable handle (150).

3. A non-blocking metal drug-eluting balloon according to claim 2, characterized in that, The covered stent (210) is arranged around the periphery of the support balloon (120).

4. A non-blocking metal drug-eluting balloon according to claim 2, characterized in that, The adjustable handle (150) is equipped with a pressure feedback module (160), which consists of a miniature pressure sensor (161) and a wireless transmission device (162).

5. A non-blocking metal drug-eluting balloon according to claim 2, characterized in that, A distal imaging ring (130) is provided between the distal end of the delivery wire (110) and the distal end of the support balloon (120).

6. A non-blocking metal drug-eluting balloon according to claim 1, characterized in that, The support balloon (120) is made of shape memory alloy wires that cross each other up and down.

7. A non-blocking metal drug-eluting balloon according to claim 1, characterized in that, The covered scaffold (210) has a spiral wound structure, and drug sustained-release microspheres (213) are disposed in the spiral gap.

8. A non-blocking metal drug-eluting balloon according to claim 1, characterized in that, The membrane-covered stent (210) is a segmented membrane structure composed of multiple axial metal wires connected in parallel, and the metal wires are covered with an independent drug-coated membrane (211a).

9. A non-blocking metal drug-eluting balloon according to claim 8, characterized in that, The proximal imaging ring (220) is provided with a blood flow monitoring unit (250), which is connected to the data line inside the external push rod (230).

10. A non-blocking metal drug-eluting balloon according to claim 1, characterized in that, The main frame (212) is composed of axially arranged wires.

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