Renal artery balloon catheter for local drug perfusion

Abstract

The utility model relates to a renal artery balloon catheter for local medicine perfusion, which comprises a catheter, a first balloon is arranged on the surface of the far end of the catheter, the near end of the catheter is connected with a handle, and the first balloon is inflated and expanded through a first inflation cavity arranged in the catheter. The surface of the far end of the catheter is connected with a plurality of medicine release needles through a remote control unfolding mechanism and an ejection mechanism, each medicine release needle comprises a needle body with the closed bottom and a needle head, the needle body is filled with medicine, and the needle head of each medicine release needle is sealed through a rapidly-dissolved biocompatible coating. The fixed depth of medicine injected into the target blood vessel wall is guaranteed through the ejection mechanism, the medicine is stored in the medicine release needle and is sealed through the rapidly-dissolved biocompatible coating to be prevented from leaking out, pushing injection through a handle is not needed, the medicine is prevented from being consumed on the inner wall of a catheter cavity in the flowing distance process, and the service life of the catheter is prolonged. The medicine dosage can be accurately guaranteed, and the medicine injection efficiency is improved.

Description

Technical Field

[0001] The utility model belongs to the technical field of renal artery balloon catheters, in particular to a renal artery balloon catheter for local drug perfusion. Background Art

[0002] Current medical approaches utilize a variety of methods to deliver drugs into the body, including oral, submucosal, parenteral, and transdermal administration. However, these approaches are often subject to nonspecific delivery, leading to potential off-target side effects. Because drug delivery efficiency is crucial in disease treatment, centralized drug delivery can improve efficacy and minimize side effects.

[0003] Directly injecting a therapeutic agent into the treatment area is one of the simplest methods for controlling therapeutic agent delivery. Directly injecting a neuroablative agent into the vascular wall of a target vessel can directly achieve neuroablation, potentially treating conditions such as refractory hypertension, refractory heart failure, and atrial fibrillation. For example, the prior art discloses a drug delivery balloon catheter (publication number CN116801932A), which can guide a needle device through the vascular network to reach the target vessel before the needle extends and pierces the target vessel to reach the target site. It can even directly inject a therapeutic agent to a specified depth in the target vessel. In this case, drug consumption must be controlled very precisely, with injection volumes of 0.1ml to 10ml being selected depending on the type of drug and the target site. However, the aforementioned design and the US patents cited in it all utilize a handle distally connected to the needle. During injection, the drug must be injected from the handle through the needle into the target site. Therefore, the amount of drug to be injected must be prepared separately for each needle before injection, which is time-consuming. The distance the drug must travel varies greatly depending on the length of the catheter used. It is also difficult to ensure that no drug solution remains in the long catheter lumen, affecting the amount of drug that ultimately reaches the target site. Utility Model Content

[0004] The technical problem to be solved by the utility model is to provide a renal artery balloon catheter for local drug perfusion, which can reduce the drug advancement distance while injecting the drug to a fixed depth in the target blood vessel wall, accurately ensure the drug dosage, and improve the injection efficiency.

[0005] The technical solution adopted by the present invention to solve its technical problems is: to provide a renal artery balloon catheter for local drug perfusion, including a catheter, a first balloon is provided on the distal surface of the catheter, the proximal end of the catheter is connected to a handle, the first balloon is inflated by a first inflation cavity provided in the catheter, the distal surface of the catheter is connected to a plurality of drug releasing needles through a remote-controlled deployment mechanism and an ejection mechanism, when the remote-controlled deployment mechanism is in a retracted state, the drug releasing needles are parallel to the axial direction of the catheter; when the remote-controlled deployment mechanism is in an deployed state, the drug releasing needles face the circumference of the catheter, when the ejection mechanism is in a retracted state, the needle tip of the drug releasing needle is lower than the highest point of the outer periphery of the inflated state of the first balloon; when the ejection mechanism is in an ejected state, the needle tip of the drug releasing needle protrudes beyond the outer periphery of the inflated state of the first balloon, the drug releasing needle includes a needle body with a closed bottom and a needle tip, the needle body is filled with drug, and the needle tip of the drug releasing needle is sealed by a fast-dissolving biocompatible coating.

[0006] Preferably, the ejection mechanism includes a second balloon provided on the distal surface of the catheter, the second balloon is inflated through a second inflation cavity provided in the catheter, and the drug releasing needle is provided on the surface of the second balloon and is ejected as the second balloon inflates.

[0007] Preferably, the remote control deployment mechanism includes a hinged connector, the drug release needle is arranged on the surface of the second balloon through the hinged connector, the first balloon is sleeved outside the second balloon, and the surface of the first balloon is provided with a first cavity facing the circumference of the catheter when inflated and a second cavity accommodating the expansion of the second balloon.

[0008] Preferably, the drug-releasing needles are evenly distributed around the circumference of the catheter.

[0009] Preferably, a plurality of lumens are provided inside the catheter, including a guidewire lumen and a working lumen connected to the handle.

[0010] The beneficial effects are as follows: the present invention ensures that the drug is injected to a fixed depth in the target blood vessel wall through the ejection mechanism; the drug stored in the drug release needle is sealed to prevent leakage through a fast-dissolving biocompatible coating; the present invention does not require injection through a handle, which can reduce the drug advancement distance and prevent the drug from being lost on the inner wall of the catheter lumen due to the flow distance process, thereby helping to accurately ensure the drug dosage and improve the injection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 Schematic diagram of the structure of a renal artery balloon catheter for local drug infusion.

[0012] Figure 2 for Figure 1A schematic diagram of the enlarged cross-section of the remote control deployment mechanism in the folded state.

[0013] Figure 3 for Figure 1 A schematic enlarged cross-sectional view of the inflation state of the remote control deployment mechanism at point A in the middle.

[0014] Figure 4 for Figure 1 A is an enlarged cross-sectional view of the ejection mechanism in the inflation state.

[0015] Among them, 1-catheter; 101-first inflation chamber; 102-second inflation chamber; 2-handle; 3-remote control deployment mechanism; 301-first balloon; 302-first cavity; 303-second cavity; 4-ejection mechanism; 401-second balloon; 402-hinged connector; 5-drug release needle.

[0016] The same reference numerals in the various drawings represent the same components. DETAILED DESCRIPTION

[0017] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. Furthermore, it should be understood that after reading the contents of this invention, those skilled in the art may make various changes or modifications to the present invention, and that such equivalents also fall within the scope of the claims appended hereto.

[0018] like Figure 1 As shown, the present invention provides a renal artery balloon catheter for local drug perfusion, comprising a catheter 1, wherein a first balloon 301 is provided on the distal surface of the catheter 1, and the proximal end of the catheter 1 is connected to a handle. The first balloon 301 is inflated through a first inflation cavity 101 provided in the catheter 1, and the distal surface of the catheter 1 is connected to a plurality of drug-releasing needles 5 via a remote-controlled deployment mechanism 3 and an ejection mechanism 4. When the remote-controlled deployment mechanism 3 is in a retracted state, the drug-releasing needles 5 are parallel to the axial direction of the catheter 1; when the remote-controlled deployment mechanism 3 is in an deployed state, the drug-releasing needles 5 face the circumference of the catheter 1; when the ejection mechanism 4 is in a retracted state, the needle tips of the drug-releasing needles 5 are positioned below the highest point of the outer periphery of the inflated first balloon 301; when the ejection mechanism 4 is in an ejected state, the needle tips of the drug-releasing needles 5 protrude beyond the outer periphery of the inflated first balloon 301. The remote-controlled deployment mechanism 3 and the ejection mechanism 4 are controlled by a control mechanism provided on the handle.

[0019] In such Figure 2 、 3In the first embodiment shown in FIG4 , the ejection mechanism 4 includes a second balloon 401 disposed on the distal surface of the catheter 1. The second balloon 401 is inflated by a second inflation chamber 102 within the catheter 1. The drug-releasing needle 5 is disposed on the surface of the second balloon 401 and ejected as the second balloon 401 inflates. The dimensions of the second balloon 401 are designed to maintain a fixed ejection distance when fully inflated, ensuring that the drug-releasing needle 5 is ejected to a depth sufficient to reach the treatment area.

[0020] The remote control deployment mechanism 3 matched with the ejection mechanism 4 includes a hinged connector 402, and the drug release needle 5 is arranged on the surface of the second balloon 401 through the hinged connector 402. The first balloon 301 is sleeved outside the second balloon 401. The surface of the first balloon 301 is provided with a first cavity 302 facing the circumference of the catheter 1 when inflated and a second cavity 303 to accommodate the expansion of the second balloon 401. The hinged connector 402 comprises a base fixed to the surface of the second balloon 401. A pin is inserted into the base and is integrally formed with the base of the drug-releasing needle 5. When the first balloon 301 is not inflated, it is in a soft state, and the drug-releasing needle 5 is retracted toward the proximal end of the catheter 1. Even if the needle tip tilts slightly during insertion, it will not damage the blood vessel wall. As the first balloon 301 inflates, the first and second cavities 302, 303 expand and stabilize. The first cavity 302 elevates the drug-releasing needle 5, pointing toward the circumference of the catheter 1. After drug release is complete, the first and second balloons 301, 401 are deflated, and the drug-releasing needle 5 is retracted after the second balloon 401 is deflated. When the catheter 1 is withdrawn from the blood vessel, the tip of the drug-releasing needle 5 naturally retracts toward the distal end of the catheter 1.

[0021] In other embodiments, the ejection mechanism 4 can adopt a mechanical structure, and the ejection mechanism 4 includes a ejection block provided on the wall of the catheter 1, and a ejection rod matching the ejection block is provided inside the catheter 1. The top end of the ejection rod is provided with a ramp, and the other end of the ejection rod is connected to the handle. By controlling the handle to push the ejection rod toward the distal end of the catheter 1, the ejection block is ejected outward by the ramp to realize the ejection function.

[0022] In one specific embodiment, the drug-delivering needle 5 comprises a sealed-bottom needle body and a needle tip. The needle body is filled with drug, and the tip is sealed with a rapidly dissolving biocompatible coating. The biocompatible coating remains solid when not in contact with the vessel wall, preventing the drug from leaking out of the needle body before reaching the intended location. Once the needle tip penetrates the vessel wall, the biocompatible coating rapidly dissolves, allowing the drug inside the needle body to flow out.

[0023] In a specific embodiment, the catheter 1 is wrapped with a sheath to further prevent the drug-releasing needle 5 from damaging the blood vessel wall when the catheter 1 enters and exits, or to avoid damage to the biocompatible coating of the needle when the catheter 1 moves, resulting in drug leakage.

[0024] In a specific embodiment, the present invention is applicable to nerve ablation, and the drug is a nerve ablative agent such as anhydrous ethanol.

[0025] In a specific embodiment, there are four drug releasing needles 5 , which are evenly distributed outside the catheter 1 circumferentially. The output of the drug can be increased by increasing the number of the drug releasing needles 5 .

[0026] In other embodiments, the catheter 1 is provided with a plurality of lumens, including a guidewire lumen and a working lumen connected to the handle, so that the catheter 1 of the present invention can also perform other tasks, such as entering a designated blood vessel via a guidewire and inserting a camera through the working lumen.

Claims

1. A renal artery balloon catheter for local drug perfusion, comprising a catheter, a first balloon provided on the distal surface of the catheter, a proximal end of the catheter connected to a handle, the first balloon being inflated through a first inflation cavity provided in the catheter, characterized in that: The distal end surface of the catheter is connected to a plurality of drug releasing needles via a remote control deployment mechanism and an ejection mechanism. When the remote control deployment mechanism is in the retracted state, the drug release needle is parallel to the axial direction of the catheter; when the remote control deployment mechanism is in the deployed state, the drug release needle faces the circumference of the catheter. When the ejection mechanism is in the retracted state, the needle tip of the drug releasing needle is lower than the highest point of the outer periphery of the first balloon in the inflated state; when the ejection mechanism is in the ejected state, the needle tip of the drug releasing needle protrudes from the outer periphery of the first balloon in the inflated state. The drug-releasing needle comprises a needle body with a closed bottom and a needle head. The needle body is filled with drugs, and the needle head of the drug-releasing needle is sealed by a fast-dissolving biocompatible coating.

2. A renal artery balloon catheter for local drug perfusion according to claim 1, characterized in that: The ejection mechanism includes a second balloon provided on the distal surface of the catheter. The second balloon is inflated by a second inflation cavity provided in the catheter. The drug releasing needle is provided on the surface of the second balloon and is ejected as the second balloon inflates.

3. The renal artery balloon catheter for local drug perfusion according to claim 2, characterized in that: The remote control deployment mechanism includes a hinged connection, the drug release needle is arranged on the surface of the second balloon through the hinged connection, the first balloon is sleeved outside the second balloon, and the surface of the first balloon is provided with a first cavity facing the circumference of the catheter when inflated and a second cavity accommodating the expansion of the second balloon.

4. The renal artery balloon catheter for local drug perfusion according to claim 1, characterized in that: The drug releasing needles are evenly distributed outside the catheter.

5. The renal artery balloon catheter for local drug perfusion according to claim 1, characterized in that: The catheter is provided with a plurality of lumens, including a guidewire lumen and a working lumen communicated with the handle.

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