Balloon catheter system for ophthalmic artery intervention

Abstract

The application provides a balloon catheter system for ophthalmic artery interventional therapy, which comprises a catheter body, the catheter body comprising a distal end and a proximal end, the distal end of the catheter body being provided with a first expandable balloon, and the proximal end of the catheter body being a control end; an administration channel, a first balloon channel and a guide channel for guiding a guide wire are arranged in the catheter body in an axial direction, a drug outlet is arranged on the catheter body, the drug outlet is communicated with the administration channel, and the first expandable balloon is communicated with the first balloon channel; a recessed side hole is arranged on the catheter body, the recessed side hole is communicated with the guide channel; and a first developing ring is arranged on the catheter body, and the first developing ring is located on the catheter body close to the first expandable balloon. The application controls the distal end expandable balloon through the control end, realizes accurate positioning, greatly improves the effect of blood flow blockage and the safety of operation, and simultaneously utilizes coaxial perfusion, a three-cavity structure and the position limitation of the drug outlet to ensure that the drug acts on a lesion at high concentration and high efficiency, increases the safety during drug administration and improves the treatment effect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a balloon catheter system for transocular artery interventional therapy, particularly suitable for chemotherapy perfusion in children with retinoblastoma and thrombolytic therapy for central retinal artery embolization in adults. Background Technology

[0002] Currently, in treating retinoblastoma in children, a common practice is to use a microcatheter inserted via the femoral artery to superselectively deliver chemotherapy drugs into the ophthalmic artery. However, children's blood vessels are thin and fragile, especially the cavernous sinus segment, where there are significant individual differences in anatomy. Traditional microcatheter superselective ophthalmic artery injection therapy presents challenges such as difficulty in achieving the desired position, poor stability, repeated manipulation leading to physical damage to the ophthalmic artery opening, and drug reflux injury. Similar problems exist for thrombolytic therapy in adult central retinal artery embolism, requiring the rapid establishment of a high-flow-rate thrombolytic drug infusion channel.

[0003] Balloon occlusion of the C7 segment of the internal carotid artery combined with intracarotid artery drug delivery is a simple procedure with minimal radiation exposure and minimal physical damage to the ophthalmic artery orifice. However, this approach temporarily blocks the carotid artery, increasing the risk of cerebral ischemia, and it is difficult to avoid some loss of chemotherapy or thrombolytic drugs. Current balloon occlusion devices cannot effectively address these issues. Therefore, it is considered by scholars both domestically and internationally as an alternative when superselective ophthalmic artery injection therapy is difficult. Summary of the Invention

[0004] To address the aforementioned technical problems, the present invention aims to provide a method that, through the design of the catheter body, enables effective control and precise positioning of the distally positioned dilation balloon, while ensuring the blood supply to the blocked blood vessel during occlusion, thereby significantly improving the efficacy of drug treatment and the safety of the procedure. To achieve the above objectives, the present invention provides a balloon catheter system for ophthalmic artery interventional therapy, comprising a catheter body, the catheter body including a distal end and a proximal end, the distal end of the catheter body being provided with an expandable balloon, and the proximal end of the catheter body being a control end; The catheter body is provided with a drug delivery channel, a balloon channel and a guide wire guide channel along the axial direction. The catheter body is provided with a drug outlet, which is located on the tube wall on the side of the expandable balloon facing the control end of the catheter body and is connected to the drug delivery channel. The expandable balloon is connected to the balloon channel. The catheter body also has a grooved side hole that communicates with the guide channel; and the catheter body is provided with a radiopaque ring located on the outside of the catheter body near the dilation balloon for guidance and identification.

[0005] In some embodiments, the guide channel is independently axially disposed within the catheter body, and a tapered guidewire is movably disposed inside it.

[0006] Preferably, the diameter of the tapered guidewire is between 0.14 and 0.35 mm, and the length is between 180 and 200 mm.

[0007] In some embodiments, the groove side hole is recessed to the outer surface of the catheter body in the direction of the inner guiding channel, the recess depth is between 10mm and 30mm, and the oblique cut surface of the recess is elliptical.

[0008] In some embodiments, a second expandable balloon is provided at the distal end of the catheter body, the second expandable balloon being located on the catheter body on the side of the first expandable balloon facing the control end; The drug outlet is located on the catheter body between the first expandable balloon and the second expandable balloon.

[0009] Preferably, the catheter body is further provided with a second balloon channel along the axial direction, and the second balloon channel is in communication with the second dilating balloon.

[0010] In some embodiments, a corrugated tube is provided at the distal end of the catheter body, and the corrugated tube is located between the first expandable balloon and the second expandable balloon for adjusting the distance between the first expandable balloon and the second expandable balloon.

[0011] In some embodiments, both the first and second dilatation balloons are made of thermoplastic polyurethane, thermoplastic polyolefin, silicone, or natural latex.

[0012] In some embodiments, the catheter body is made of polymer or metal materials.

[0013] The polymer material is one of block polyether amide resin, polytetrafluoroethylene, or polyethylene terephthalate. The metal material is either stainless steel or nickel-titanium alloy.

[0014] The system also provides an application of the balloon catheter described above, primarily for the treatment of retinoblastoma via ophthalmic artery chemotherapy, and for the treatment of central retinal artery embolization via ophthalmic artery thrombolytic drug injection. The system delivers the outer surface of the dilating balloon to the lesion site via a guidewire, and the balloon expands to achieve adhesion and blockage to the inner wall of the blood vessel, releasing the drug from the outlet.

[0015] Compared with the prior art, the balloon catheter system for transocular artery interventional therapy provided by the present invention has at least one of the following beneficial effects: 1. Personalized treatment: The control end of the catheter body is used to effectively control the distal dilation balloon, achieving precise positioning and greatly improving the effect of blood flow occlusion and surgical safety.

[0016] 2. Unique "Cavity" Design: While ensuring effective perfusion of chemotherapy drugs to the target after blocking blood flow in the internal carotid artery, it also maintains cerebral blood flow perfusion, greatly reducing the risk of cerebral ischemia, and prolonging the "burst release" drug delivery time to improve drug treatment efficiency.

[0017] 3. Multi-purpose device: The main body of the catheter is designed to consist of two parts, an inner and an outer part. Through different size designs, it can cover patient groups from infants to adults, as well as two diseases: tumor chemotherapy and arterial thrombolysis, which greatly reduces the hospital's equipment procurement and management costs.

[0018] 4. High treatment efficiency: The optimized coaxial drug delivery structure and the adjustable spacing between the dilatation balloons ensure that the drug is delivered to the lesion at a high concentration and with high efficiency, reducing systemic side effects.

[0019] 5. High operability: Complex functions can be achieved on catheters of 5F (F (F) is a unit for measuring the outer circumference of instruments such as catheters and sheaths, and 1F is approximately equal to a diameter of 0.33mm) and above, which meets the stringent requirements of instruments for interventional treatment in children. Attached Figure Description

[0020] The preferred embodiments will now be described in a clear and easy-to-understand manner, in conjunction with the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages, and implementation methods of the present invention.

[0021] Figure 1 This is a schematic diagram of an embodiment of a balloon catheter system used for ophthalmic artery interventional therapy; Figure 1a yes Figure 1 Schematic diagram of the cross-sectional structure of section AA; Figure 1b yes Figure 1 Schematic diagram of the cross-sectional structure of section BB; Figure 1c yes Figure 1 Schematic diagram of the cross-sectional structure of the CC section; Figure 2 This is a schematic diagram of a second embodiment of a balloon catheter system used for ophthalmic artery interventional therapy; Figure 2a yes Figure 2 Schematic diagram of the cross-sectional structure of section AA; Figure 2b yes Figure 2 Schematic diagram of the cross-sectional structure of section BB; Figure 2c yes Figure 2Schematic diagram of the cross-sectional structure of the CC section; Figure 3 This is a schematic diagram of the structure of a balloon catheter system for ophthalmic artery interventional treatment, as shown in Example 3. Figure 3a yes Figure 3 Schematic diagram of the cross-sectional structure of section AA; Figure 3b yes Figure 3 Schematic diagram of the cross-sectional structure of section BB; Figure 3c yes Figure 3 Schematic diagram of the cross-sectional structure of the CC section; Figure 4 This is a schematic diagram of the structure of a balloon catheter system for ophthalmic artery interventional treatment, Example 4; Figure 4a yes Figure 4 Schematic diagram of the cross-sectional structure of section AA; Figure 4b yes Figure 4 Schematic diagram of the cross-sectional structure of section BB; Figure 4c yes Figure 4 Schematic diagram of the cross-sectional structure of the CC section; Figure 5 yes Figure 4 Schematic diagram of the structure of the Chinese and foreign catheters; Figure 6 yes Figure 4 Schematic diagram of the internal catheter structure; Explanation of icon numbers: Catheter body 1; outer catheter 11; inner catheter 12; distal end 13; proximal end 14; drug delivery channel 15; first balloon channel 16; guiding channel 17; second balloon channel 18; stretching channel 19; Expandable balloon 2; First expandable balloon 21; Second expandable balloon 22; Discharge port 3; Developing ring 4; First developing ring 41; Second developing ring 42; 5. Corrugated pipe; 6. Pulling wire; Control handle 7; Groove side hole 8, drainage cavity 81. Detailed Implementation

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0023] To keep the drawings concise, each figure only schematically shows the parts relevant to the invention, and these do not represent the actual structure of the product. Furthermore, to facilitate understanding, in some figures, only one of components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0024] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0025] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0026] Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

[0027] refer to Figure 1 , 1a1b, 1c, This invention provides a balloon catheter system for ophthalmic artery interventional therapy, comprising a catheter body 1, the catheter body 1 including a distal end 13 and a proximal end 14, the distal end 13 of the catheter body 1 being provided with an expandable balloon 2, and the proximal end 14 of the catheter body 1 being a control end; the catheter body 1 is provided with a drug delivery channel 15, a balloon channel and a guide wire guide channel 17 along the axial direction, and the catheter body 1 is provided with a drug outlet 3, which is located on the wall of the expandable balloon 2 on the side facing the control end of the catheter body 1 and communicates with the drug delivery channel 15, while the expandable balloon 2 is communicated with the balloon channel; Meanwhile, a grooved side hole 8 is also provided on the catheter body 1, which is connected to the guide channel 17. A contrast ring 4 is also provided on the catheter body 1. Specifically, the contrast ring 4 is set on the catheter body 1 on the side of the dilation balloon facing the control end, close to the dilation balloon. When in use, the guide wire controls the dilation balloon to pass through the blood vessel through the guide channel 17. At the same time, the X-ray imaging of the contrast ring 4 achieves precise positioning. Finally, the drug is infused through the drug delivery channel 15. Due to the limited position of the drug outlet 3, the drug can be efficiently delivered to the lesion, which greatly improves the precision and safety of minimally invasive surgery.

[0028] In practical use, the above embodiment can preferably have the guiding channel 17 independently axially positioned within the catheter body 1 to avoid communication with other channels, especially the drug delivery channel 15. This allows for the internal placement of a tapered guidewire to guide the entire catheter body 1. The tapered guidewire has a diameter between 0.14-0.35 mm and a length between 180-200 mm. In this embodiment, the total length of the tapered guidewire is preferably set between 180-200 mm, with the tip (near the distal end 13) at 60-80 mm and a diameter of 0.14 mm (10 mm at the tip, ultra-soft and malleable); the middle portion at 60 mm and a diameter of 0.18 mm; and the proximal end (near the proximal end 14) at 60 mm and a diameter of 0.35 mm, so that the diameter of the entire tapered guidewire gradually tapers from the proximal end 14 towards the distal end 13.

[0029] In addition, the groove side hole 8 opened on the side wall of the catheter body 1 can be set in various ways. In this application, preferably, the groove side hole 8 is recessed from the outer surface of the catheter body 1 toward the inner guide channel 17, and the recess depth is between 10mm and 30mm. At the same time, the oblique cut surface of the recess is set to be elliptical. In this way, a drainage cavity 81 is formed between the groove side hole 8 and the guide channel 17, so as to effectively control and accurately position the expandable balloon 2 set at the distal end 13. At the same time, under the premise of ensuring effective perfusion of chemotherapy drugs to the target after blocking the blood flow of the internal carotid artery, the connection between the drainage cavity 81 and the guide channel 17 maintains cerebral blood flow perfusion, which greatly reduces the risk of cerebral ischemia and improves the drug treatment effect and surgical safety.

[0030] See Figure 2 , 2a As shown in 2b and 2c, Embodiment 2 makes further improvements on the above basic setup. The improvements are as follows: two expandable balloons 2 are provided at the distal end 13 of the catheter body 1, namely the first expansion balloon and the second expansion balloon. The first expansion balloon is located at the distal end 13 of the catheter body 1, while the second expansion balloon is located on the side of the catheter body 1 facing the control end of the first expandable balloon 21, with a certain distance between them. At the same time, the drug outlet 3 is located on the catheter body 1 between the first expansion balloon and the second expansion balloon and is connected to the drug delivery channel 15 provided inside the catheter body 1. In this way, the two expansion balloons can accurately locate the treatable site and improve the treatment effect.

[0031] Specifically, a second balloon channel 18 is provided axially inside the catheter body 1, and the second balloon channel 18 is connected to the second dilatation balloon. In use, the second dilatation balloon travels through the blood vessel under the guidance of the guide wire. After positioning, the second dilatation balloon can be operated at the control end using the second balloon channel 18.

[0032] In practical use, besides the guidance of the guidewire, the first contrast-enhancing ring 414 plays a crucial role in the precise positioning of the first dilating balloon. Therefore, to more accurately control the second dilating balloon to reach the designated position, preferably, a second contrast-enhancing ring 424 is further provided on the catheter body 1. The second contrast-enhancing ring 424 is positioned between the first and second dilating balloons, closer to the second dilating balloon on the catheter body 1. This not only allows the two dilating balloons to accurately position the treatable site but also effectively confines the medication within a certain range, improving the treatment effect.

[0033] See Figure 3 , 3a As shown in 3b and 3c, Embodiment 3 is a further improvement on the above embodiments. The improvement is that, preferably, a corrugated tube 5 is further provided at the distal end 13 of the catheter body 1, and the specific position of the corrugated tube 5 is located between the first expandable balloon 21 and the second expandable balloon 22. In actual use, the length of the corrugated tube 5 is set according to actual needs, which will not be described in detail in this application. In this way, the distance between the first expandable balloon 21 and the second expandable balloon 22 can be adjusted by adjusting the corrugated tube 5, which is simple to operate and greatly improves the efficiency of use.

[0034] Specifically, there are various ways to adjust the bellows 5. In this embodiment, preferably, a tension channel 19 is also provided axially inside the catheter body 1. A traction coin 6 passes through the tension channel 19 and is connected to the bellows 5. In this way, the tension of the traction coin 6 can effectively control the bellows 5 to switch between the extended and retracted states. Thus, by moving the bellows 5 axially, the specific distance between the two expandable balloons 2 can be quickly adjusted. In actual use, the balloon placement position can be adjusted in real time and accurately according to the "actual length of the internal carotid artery C5-C7 segment" shown by intraoperative angiography to achieve the best blood flow blocking effect.

[0035] See Figure 4 , 4a As shown in 4b and 4c, Embodiment 4 is a further improvement on the above embodiments. The improvement is that, preferably, there are various ways to set the catheter body 1. In this embodiment, the catheter body 1 is set as an external catheter 11, see... Figure 5 As shown, an internal catheter 12 is provided. Figure 6 As shown, the external catheter 11 is equipped with a first dilation balloon, and the internal catheter 12 is equipped with a second dilation balloon. In use, the internal catheter 12 is slidably positioned within the external catheter 11, with an inflation cavity between them to accommodate the second dilation balloon. This design of the catheter body 1 allows for multiple uses from a single unit, catering to patients ranging from infants to adults, and enabling treatment of both tumor chemotherapy and arterial thrombolysis, thus reducing hospital equipment procurement and management costs.

[0036] It should be noted that in the above embodiments, both the first and second dilatation balloons are made of thermoplastic polyurethane (TPU), thermoplastic polyolefin (TPE), silicone, or natural latex. The catheter body 1 is made of a polymer material or a metal material, wherein the polymer material is one of block polyetheramide resin (Pebax), polytetrafluoroethylene (PTFE), or polyethylene terephthalate (PET), and the metal material is one of stainless steel or nickel-titanium alloy.

[0037] In actual use, to facilitate precise operation at the control end, a control handle 7 is further provided. The control handle 7 is connected to the control end of the catheter body 1 through a connector. Simultaneously, to disperse, buffer, and redistribute the stress (i.e., tensile force, bending force, and shear force) borne by the catheter body 1 at the fixed point (skin puncture point), and to protect the catheter body 1 and patient tissue, a stress diffusion tube is fitted onto the control end of the catheter body 1, connected to the connector through the stress diffusion tube. Furthermore, the distal end 13 of the catheter body 1 has a certain length, preferably 20mm in this application, and the outer surface of the distal end 13 is beveled to increase the blood outflow area and prevent jetting.

[0038] The specific choice depends on actual needs. The purpose of this design is to improve support, while using ultra-soft materials to ensure sufficient support and reduce vascular spasm caused by stimulation of the guide tube under the influence of blood vessel wall stimulation.

[0039] This application also provides an application method of the balloon catheter system described above, which is mainly used for ophthalmic artery injection chemotherapy drug perfusion therapy for the treatment of retinoblastoma, and for ophthalmic artery injection thrombolytic drug therapy for central retinal artery embolization. The outer surface of the balloon is delivered to the lesion site through the guide wire, and the balloon is expanded to achieve adhesion and blockage to the inner wall of the blood vessel and release the drug from the outlet 3.

[0040] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A balloon catheter system for ophthalmic artery interventional therapy, characterized in that, include: The catheter body includes a distal end and a proximal end, the distal end of the catheter body is provided with a first expandable balloon, and the proximal end of the catheter body is a control end; The catheter body is provided with a drug delivery channel, a first balloon channel and a guide wire guide channel along the axial direction. The catheter body is provided with a drug outlet, which is located on the tube wall on the side of the first expandable balloon facing the control end of the catheter body and is connected to the drug delivery channel. The first expandable balloon is connected to the first balloon channel. The catheter body also has a grooved side hole that communicates with the guide channel; and the catheter body is provided with a radiopaque ring, which is located on the outside of the catheter body near the first dilation balloon and is used for guidance and identification.

2. The balloon catheter system for ophthalmic artery interventional therapy according to claim 1, characterized in that: The guide channel is independently axially located within the catheter body, and a gradient guidewire is movably installed inside it.

3. A balloon catheter system for ophthalmic artery interventional therapy according to claim 2, characterized in that: The diameter of the tapered guidewire is between 0.14 and 0.35 mm, and the length is between 180 and 200 mm.

4. A balloon catheter system for ophthalmic artery interventional therapy according to claim 1, characterized in that: The groove side hole is a recess that extends from the outer surface of the catheter body toward the inner guide channel, with a depth between 10mm and 30mm, and the oblique cut surface of the recess is elliptical.

5. A balloon catheter system for ophthalmic artery interventional therapy according to claim 1, characterized in that: The distal end of the catheter body is provided with a second expandable balloon, which is located on the catheter body on the side of the first expandable balloon facing the control end; The drug outlet is located on the catheter body between the first expandable balloon and the second expandable balloon.

6. A balloon catheter system for ophthalmic artery interventional therapy according to claim 5, characterized in that: The catheter body is further provided with a second balloon channel along the axial direction, and the second balloon channel is connected to the second dilating balloon.

7. A balloon catheter system for ophthalmic artery interventional therapy according to claim 5, characterized in that: The distal end of the catheter body is also provided with a corrugated tube, which is located between the first expandable balloon and the second expandable balloon, and is used to adjust the distance between the first expandable balloon and the second expandable balloon.

8. A balloon catheter system for ophthalmic artery interventional therapy according to any one of claims 1-7, characterized in that: Both the first and second dilatation balloons are made of one of the following materials: thermoplastic polyurethane, thermoplastic polyolefin, silicone, or natural latex.

9. A balloon catheter system for ophthalmic artery interventional therapy according to any one of claims 1-7, characterized in that: The catheter body is made of polymer or metal materials; The polymer material is one of block polyether amide resin, polytetrafluoroethylene, or polyethylene terephthalate. The metal material is either stainless steel or nickel-titanium alloy.

10. An application of the balloon catheter system as described in any one of claims 1-9, characterized in that: Chemotherapy drugs injected into the ophthalmic artery for the treatment of retinoblastoma are delivered to the lesion site via a guide wire through the outer surface of an expanding balloon. The balloon expands to achieve adhesion and blockage to the inner wall of the blood vessel and releases the drug from the outlet.

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