CN111603664A - Balloon catheter - Google Patents

Abstract

The invention provides a balloon catheter. The balloon catheter includes a catheter body and a balloon disposed at the distal end of the catheter body; after the balloon is inflated, it has a first groove that penetrates axially, and the first groove forms blood flow a passage, and a second groove between the two ends, the second groove forms a treatment area, and the blood flow passage and the treatment area are not communicated with each other; the interior of the catheter body has a main lumen, a filling lumen and a drug delivery cavity isolated from each other The distal end of the filling cavity communicates with the interior of the balloon to deliver the filling medium to realize the filling of the balloon; the distal end of the drug delivery cavity communicates with the treatment area to deliver medicine to the treatment area. The balloon catheter of the present invention can stay in the superior blood vessel of the target blood vessel for local administration, the operation difficulty is low, and the risk of iatrogenic injury can be reduced. Ensure blood flow to distal tissues.

Description

Balloon catheter

technical field

The invention relates to the technical field of medical devices, in particular to a balloon catheter.

Background technique

Local drug delivery in the human cardiovascular system has a wide range of clinical applications, such as local drug thrombolysis for vascular embolism (including embolization of cerebral blood vessels, peripheral arteries or mesenteric arteries), local drug hemostasis in patients with local bleeding disorders, and Some patients with special treatment purposes, such as chemical ablation of the ventricular septum in patients with hypertrophic cardiomyopathy or chemical ablation of refractory ventricular tachycardia. Compared with systemic administration, local site administration has higher targeting, avoids the adverse effects of drugs flowing through the body on other tissues, and has a smaller drug dose and higher drug release efficiency. Compared with mechanical physical surgery methods, local drug delivery can reach blood vessels with smaller inner diameters, and the drug delivery safety is higher, avoiding secondary mechanical damage to the tissue.

In the prior art, a balloon catheter is often used for local drug administration. Taking the local drug thrombolysis of vascular embolism as an example, when using, a guide wire is used as a guide to send the balloon catheter into the target site of the target blood vessel, and then the balloon is used. The filling is attached to the inner wall of the blood vessel to form a closed treatment area, and thrombolytic drugs are injected into the treatment area for treatment. However, this local site drug delivery method has the following problems: As shown in Figure 1a, the balloon catheter (not shown) needs to be guided by the guide wire 5 into the target blood vessel 7. When the inner diameter of the target blood vessel 7 is small, the guide wire 5. It is difficult to enter the target blood vessel 7 as a branch from the superior blood vessel 6, and it is easy to damage the endothelium of the target blood vessel 7, causing iatrogenic damage, so it is difficult to guide superselective thrombolysis.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a balloon catheter, which is suitable for local administration of small blood vessels that are difficult to enter with a guide wire, without blocking the blood flow at the distal end, and ensuring the blood supply of the distal tissue.

In order to achieve the above object, the present invention provides a kind of balloon catheter, and the balloon catheter comprises a catheter body and a balloon, and the balloon is arranged at the distal end of the catheter body; wherein:

After the balloon is inflated, a first groove that penetrates axially is formed, and the first groove constitutes a blood flow passage; after the balloon is inflated, a second groove is formed between the two ends, and the second groove is The groove constitutes a treatment area, and the blood flow path and the treatment area are not communicated with each other;

The catheter body has a main lumen, a filling lumen and a drug delivery lumen isolated from each other, the two ends of the main lumen form openings, and the distal end of the filling lumen communicates with the inside of the balloon, so the The distal end of the drug delivery lumen communicates with the treatment area.

Optionally, after the balloon is inflated, the distal end of the catheter body is partially covered along the circumference of the catheter body, and a part of the circumferential sidewall of the distal end of the catheter body is exposed to form the blood flow. and/or, after the balloon is inflated, a part of the sidewall of the distal end of the catheter body is exposed between the two ends of the balloon to form the treatment area.

Optionally, the treatment area is located on one side of the catheter body, and the blood flow passage is located on the side of the catheter body facing away from the treatment area.

Optionally, the catheter body is arranged coaxially with the balloon; the shape of the cross section of the treatment area is a fan ring, and/or the shape of the cross section of the blood flow passage is a fan ring.

Optionally, the shape of the cross section of the treatment area is a fan ring, and the central angle is 60° to 120°; and/or, the shape of the cross section of the blood flow passage is a fan ring, and the central angle is 60° to 120°; 120°.

Optionally, the cross-section of the treatment zone is smaller than the cross-section of the blood flow passage.

Optionally, the balloon catheter further includes a pressure control valve and a pressure measuring device, the pressure control valve is arranged on the filling cavity, and is used to adjust the pressure in the balloon, and the pressure measuring device is connected to the pressure measuring device. The pressure control valve is connected for monitoring the pressure in the balloon.

Optionally, the balloon catheter further includes a developing part, and the developing part is arranged on the catheter body and is located at or near the section of the treatment area.

Optionally, the developing member is a metal wire, and the metal wire is arranged on the inner wall or outer wall of the drug delivery channel, or is arranged on the inner wall of the main channel; The material is made by coating the inner wall of the drug delivery channel, the outer wall of the drug delivery channel, or the inner wall of the main channel.

Optionally, the main lumen is arranged coaxially with the catheter body, and the filling lumen and the drug delivery lumen are arranged on opposite sides of the main lumen.

The balloon catheter of the present invention has the following advantages:

The balloon catheter of the present invention can stay in the superior blood vessel of the target blood vessel for local administration, which helps to reduce iatrogenic injury and surgical complications. Specifically, after the balloon catheter is inserted into the superior blood vessel, the balloon is inflated Adhesion to the blood vessel wall to form a closed space as a treatment area to ensure that the drug will not leak out. The opening of the treatment area is facing the entrance of the target blood vessel to ensure that the drug targets the target blood vessel, and at the same time forms a blood flow path without blocking The blood flow ensures the blood supply of the distal tissue.

Description of drawings

Fig. 1a is a schematic diagram of a guide wire of an existing balloon catheter entering a target blood vessel;

Fig. 1b is a schematic diagram of the guide wire of the present invention entering a target blood vessel;

2 is a schematic structural diagram of a balloon catheter according to an embodiment of the present invention;

3 is an enlarged schematic view of the partial structure of the balloon catheter of the embodiment shown in FIG. 2;

4a is a cross-sectional view of the balloon catheter of the embodiment shown in FIG. 3 along the A-A plane;

4b is a cross-sectional view of the balloon catheter of the embodiment shown in FIG. 3 along the B-B plane;

FIG. 4c is a cross-sectional view of the balloon catheter of the embodiment shown in FIG. 3 along the C-C plane.

Description of reference numbers:

1-Catheter body, 11-Main lumen, 12-Filling lumen, 121-Filling hole, 13-Administration lumen, 131-Thread joint, 132-Administration hole; 2-Balloon, 21-Blood flow channel , 22-treatment area, 3-development part, 4-pressure control valve, 5-guide wire, 6-superior blood vessel, 7-target blood vessel.

Detailed ways

In order to make the content of the present invention clearer and easier to understand, the present invention will be further described below with reference to the accompanying drawings and embodiments of the description. But it can be understood that the present invention is not limited to the specific embodiments described below, and general replacements well known to those skilled in the art are also encompassed within the protection scope of the present invention. It should be noted that, the accompanying drawings are all in a very simplified form and in an inaccurate scale, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention.

It should be understood that, in the following description, reference to "on" and "under" various components may be made based on the drawings. Spatial terms such as "under", "under", "below", "above", etc., are used for the purpose of easily describing the positional relationship between one element and another element shown in the drawings, except in the drawings. In addition to the orientation shown, spatially relative terms may include various orientations of the device in use or operation. The device may be otherwise oriented, such as rotated 90 degrees or at other orientations, and interpreted accordingly by the spatially relative descriptions used herein.

It should also be understood that in the following description, "proximal end" and "distal end" refer to the relative orientation, relative position and orientation of elements or actions relative to each other from the perspective of the physician using the medical device, although "proximal end" " and "distal" are not limiting, but "proximal" generally refers to the end of the balloon catheter that is close to the physician during normal operation, and accordingly "distal" generally refers to the balloon catheter during normal operation. The end away from the doctor. In addition, "connection" includes direct connection between systems, components, and parts, and also includes connection between systems, components, and parts through a medium, that is, indirect connection.

The core idea of the present invention is to provide a balloon catheter, which includes a catheter body and a balloon disposed at the distal end of the catheter body. After the balloon is inflated, an axially penetrating first groove is formed. The groove constitutes a blood flow passage, and after the balloon is inflated, a second groove is formed between two ends, and the second groove constitutes a treatment area. The balloon catheter of the present invention is used to stay in the superior blood vessel of the target blood vessel for drug delivery. The superior blood vessel is usually easier to reach, thicker and less damaged than the target blood vessel, which helps to reduce the risk of surgical iatrogenic injury and surgical complications . When in use, the balloon catheter is rotated to change the circumferential position of the superior blood vessel, so that the treatment area is aligned with the entrance of the target blood vessel, and the drug is delivered to the treatment area and enters the target blood vessel to produce therapeutic effects such as embolization or thrombolysis. . The balloon catheter of the present invention can also directly enter the target blood vessel to deliver related drugs, and the stability of the blood flow path is high, which is beneficial to ensure the blood flow supply of the distal tissue.

The balloon catheter of the present invention will be described in detail below with reference to the preferred embodiments of FIGS. 1 b to 4 c.

As shown in FIGS. 1 b to 4 c , the present embodiment relates to a balloon catheter 100 , which includes a catheter body 1 and a balloon 2 , and the balloon 2 is disposed at the distal end of the catheter body 1 . After the balloon 2 is filled, a first groove is formed axially through, and the first groove constitutes the blood flow passage 21, and after the balloon 2 is filled, a second groove is formed between the two ends. The two grooves constitute the treatment area 22, and the blood flow passage 21 and the treatment area 22 are not communicated with each other. Here, the position between the two ends of the balloon 2 refers to the middle position of the balloon 2 far away from both ends as shown in FIG. The medicine in 1 is blocked by the two ends of the balloon 2, so that the therapeutic medicine released here will not flow into other positions of the superior blood vessel 6, but can only flow toward the target blood vessel 7, so as to realize the precise release of the medicine.

In addition, the interior of the catheter body 1 has a main lumen 11, a filling lumen 12 and a drug delivery lumen 13 which are isolated from each other. The two ends of the main lumen 11 form openings for inserting the guide wire 5; the distal end of the filling lumen 12 communicates with the interior of the balloon 2 for delivering filling medium to inflate the balloon 2; the drug delivery lumen 13 The distal end of the device is communicated with the treatment area 22 for delivering drugs, such as thrombolysis, embolization or hemostatic drugs, the types of drugs are not limited in the present invention.

As shown in FIG. 1b, in a preferred operation, the balloon catheter 100 of the present invention is used to stay in the superior blood vessel 6 of the target blood vessel 7 for drug administration. Therefore, the guide wire 5 does not need to enter the target blood vessel 7, because The superior blood vessel 6 is easier to reach, thicker and less damaged than the target blood vessel 7, thereby reducing the difficulty of the operation and reducing the occurrence of surgical injury and surgical complications. In specific use, the position of the balloon 2 in the circumferential direction of the superior blood vessel 6 can be changed by rotating, so that the treatment area 22 is aligned with the entrance of the target blood vessel 7, and the medicine is delivered through the drug delivery cavity 13, and the medicine reaches the treatment area 22 and enters the target blood vessel 7. and produce therapeutic effects such as embolization or thrombolysis. In addition, the blood flow in the superior blood vessel 6 can flow through the blood flow passage 21, ensuring the blood flow supply of the distal tissue. In other embodiments, the balloon catheter 100 of the present invention is also suitable for the situation of directly entering the target blood vessel 7 for drug delivery. Since the blood flow passage 21 has high stability, it is beneficial to ensure the blood flow supply of the distal tissue.

In this embodiment, after the balloon 2 is inflated, the distal end of the catheter body 1 is partially covered along the circumference of the catheter body 1 to expose a part of the side wall of the distal end of the catheter body 1 to form a blood flow passage 21, that is, the balloon 2 is a special-shaped balloon (ie, the circumferential direction is incomplete). The present invention does not limit the shape of the blood flow passage 21 . Further, after the balloon 2 is inflated, a part of the side wall of the distal end of the catheter body 1 is exposed between the two ends to form the treatment area 22 , that is, a gap is formed between the two ends after the balloon 2 is inflated to provide the treatment area 22 . In an alternative embodiment, the blood flow passage 21 and/or the treatment area 22 may be formed by concaving the outer surface of the balloon 2 in the direction of the axis of the balloon 2 .

The length of the catheter body 1 is not limited in the present invention. The length of the catheter body 1 is sufficient to maintain the puncture from the peripheral blood vessel to the target blood vessel. In actual operation, the catheter body 1 with different lengths, models and specifications can be configured to meet clinical needs. . The inner diameter of the main lumen 11 is set according to the outer diameter of the guide wire 5, and a variety of catheter bodies 1 can be configured to provide the main lumen 11 of different models and specifications. The treatment area 22 is preferably located on one side of the catheter body 1, and the blood flow channel 21 is located on the side of the catheter body 1 facing away from the treatment area 22 to reduce interference between the treatment area 22 and the blood flow channel 21. The catheter body 1 is preferably arranged coaxially with the balloon 2, the shape of the cross-section of the treatment area 22 is preferably a fan ring, and the central angle is, for example, 60°˜120°; and/or, the shape of the cross-section of the blood flow passage 21 is preferably a The fan is annular, and the central angle is, for example, 60° to 120°, so as to make the structure compact. The cross-section of the treatment zone is smaller than the cross-section of the blood flow pathway. The blood flow passage 21 and the treatment area 22 can also be set in other manners, which all fall within the protection scope of the present invention.

As shown in Figures 4a-4b, the balloon catheter 100 is shown in cross-section along the proximal end, the intermediate position and the distal end, respectively. Preferably, the main lumen 11 is arranged coaxially with the catheter body 1, and more preferably, the filling lumen 12 and the drug delivery lumen 13 are oppositely arranged on both sides of the main lumen 11, making the structure more compact. Specifically, the distal end of the filling lumen 12 has at least one filling hole 121, and the at least one filling hole 121 penetrates the catheter body 1 and directly communicates with the interior of the balloon 2, and is used to deliver the filling medium to the balloon 2. The distal end of the drug delivery lumen 13 has at least one drug delivery hole 131, and the at least one drug delivery hole 131 penetrates through the catheter body 1 and directly communicates with the treatment area 22 for delivering medicine to the treatment area 22.

As shown in FIG. 2 , the balloon catheter 100 preferably further includes a pressure control valve 4 . The pressure control valve 4 is arranged on the filling cavity 12 , preferably at the proximal end of the filling cavity 12 , and the function is to adjust the pressure inside the balloon 2 . . The balloon catheter 100 also preferably includes a pressure measuring device (not shown in the figure), and the pressure control valve 4, such as a ventilation valve with anti-reflux function, can be connected with the pressure measuring device, and the pressure measuring device is used for monitoring the balloon 2 Internal pressure. When in use, a syringe (not shown in the figure) is connected to the pressure control valve 4, and a filling medium is injected or withdrawn into the pressure control valve 4, such as air, physiological saline or a mixed liquid of physiological saline and a contrast agent, etc., Thereby, the pressure inside the balloon 2 and the size of the balloon 2 are adjusted. Further, the balloon catheter 100 has a threaded joint 131, which is connected to the proximal end of the drug delivery cavity 13, and the threaded joint 131 is used for connecting with an external device, and the drug is injected into the drug delivery cavity 13 through the external device. The type of the external device is not limited, for example, it can be a three-way pipe, an infusion extension tube, a syringe, or the like.

As shown in FIG. 3 , the balloon catheter 100 preferably further includes a developing member 3 made of a developing material, and the developing member 3 is provided in a section of the catheter body 1 located at or near the treatment area 21. In some embodiments, the developing member 3 is, for example, a metal wire, and the metal wire is arranged on the inner wall or outer wall of the drug delivery channel 13, or is arranged on the inner wall of the main channel 11. In other embodiments, the developing member 3 is formed by coating the developing material on the inner wall or the outer wall of the drug delivery channel 13, or on the inner wall of the main channel 11.

The working principle of the balloon catheter 100 of the present invention is exemplified by the preferred embodiments shown in Figures 1b to 4c below. The operation of the balloon catheter 100 generally includes the following steps:

Step 1. After the vascular access is established by surgery, the guide wire 5 is sent into the superior blood vessel 6 of the target blood vessel 7 .

Step 2. Keep the position of the guide wire 5 unchanged, the balloon catheter 100 reaches the superior blood vessel 6 along the guide wire 5, and the imaging component 3 is developed under X-ray to confirm the position and depth of the balloon catheter 100, and to ensure the treatment The direction in which the zone 22 faces is directly opposite the entry direction of the target blood vessel 7 .

Step 3. Inject air (or other filling medium, such as normal saline, etc.) into the pressure control valve 4 to fill the balloon 2, and fix the balloon 2 by the pressure of the filled balloon 2 on the vessel wall of the superior blood vessel 6. .

Step 4. Withdraw the guide wire 5, and further confirm the position of the balloon 2 and whether the treatment area 22 is facing the entrance of the target blood vessel 7 by injecting the contrast agent into the main lumen 11 and the administration lumen 13, and confirm the treatment area 22 is there any leakage of contrast agent. If there is leakage of contrast agent in the treatment area 22, it indicates that the pressure of the balloon 2 is insufficient, and there is a risk of drug leakage. If the alignment is not good or there is drug leakage, the filling medium in the balloon 2 can be properly leaked, and the circumferential orientation between the catheter body 1 and the superior blood vessel 6 can be fine-tuned under the guidance of X-rays, so that the treatment area 22 covers the target blood vessel 7 . entrance.

Step 5. After confirming that the treatment area 22 covers the entrance of the target blood vessel 7, inject the therapeutic drug into the drug delivery channel 13 for treatment, and at the same time, the blood flow in the target blood vessel 7 can flow through the blood flow passage 12 to ensure that the distal tissue blood supply.

Step 6. After the administration is completed, all filling media in the balloon 2 are exhausted through the pressure control valve 4, so that the balloon 2 is contracted, and then the balloon catheter 100 is withdrawn.

To sum up, the balloon catheter of the present invention can stay in the superior blood vessel of the target blood vessel (more accessible than branch blood vessels, thicker and less damaged). The space is used as a treatment area, and the treatment area is facing the entrance of the target blood vessel, which realizes precise local drug delivery, reduces iatrogenic injury and complications, and the blood flow in the superior blood vessels can flow through the blood flow channel, ensuring the remote tissue It reduces the damage to the distal tissue and improves the medical effect.

The above description is only a description of some embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention according to the above disclosure all belong to the protection scope of the present invention.

Claims (10)

1. The balloon catheter is characterized by comprising a catheter body and a balloon, wherein the balloon is arranged at the far end of the catheter body; wherein:

the balloon is inflated to form a first groove which is axially communicated, and the first groove forms a blood flow passage; a second groove is formed between the two ends of the balloon after the balloon is inflated, the second groove forms a treatment area, and the blood flow passage is not communicated with the treatment area;

the catheter body is provided with a main cavity channel, a filling cavity channel and a drug delivery cavity channel which are isolated from each other, openings are formed at two ends of the main cavity channel, the far end of the filling cavity channel is communicated with the inside of the balloon, and the far end of the drug delivery cavity channel is communicated with the treatment area.

2. A balloon catheter according to claim 1, wherein the balloon partially covers the distal end of the catheter body in a circumferential direction of the catheter body after filling and exposes a portion of a circumferential sidewall of the distal end of the catheter body to form the blood flow path, and/or wherein the balloon partially exposes a portion of a sidewall of the distal end of the catheter body between the ends of the balloon to form the treatment region after filling.

3. A balloon catheter according to claim 2, wherein said treatment area is located on a side of said catheter body and said blood flow passageway is located on a side of said catheter body opposite said treatment area.

4. A balloon catheter according to claim 2 or 3, wherein the catheter body is arranged coaxially with the balloon; the cross-section of the treatment area is in the shape of a sector ring, and/or the cross-section of the blood flow passage is in the shape of a sector ring.

5. The balloon catheter of claim 4, wherein the cross-section of the treatment area has a shape of a sector ring with a central angle of 60 ° to 120 °; and/or the cross section of the blood flow passage is in a fan-shaped ring shape, and the central angle is 60-120 degrees.

6. The balloon catheter of claim 4, wherein the treatment region has a cross-section smaller than a cross-section of the blood flow passageway.

7. The balloon catheter of claim 6, further comprising a pressure control valve disposed on the inflation lumen in fluid communication with the balloon for regulating pressure within the balloon, and a pressure measurement device coupled to the pressure control valve for monitoring pressure within the balloon.

8. A balloon catheter according to claim 1, further comprising a visualization member disposed on the catheter body at or near a section of the treatment region.

9. The balloon catheter according to claim 8, wherein the visualization member is a wire disposed on an inner or outer wall of the administration lumen, or on an inner wall of the main lumen; or the developing component is made by coating the developing material on the inner wall of the drug administration cavity, the outer wall of the drug administration cavity or the inner wall of the main cavity.

10. The balloon catheter of claim 1, wherein the main lumen is coaxially disposed with the catheter body, and the inflation lumen and the administration lumen are disposed on opposite sides of the main lumen.

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