Pouring plugging balloon catheter and manufacturing process thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to a pourable blocking balloon catheter and a manufacturing process thereof. The pourable blocking balloon catheter comprises a circular-tube-shaped flexible outer layer film and at least two flat balloons fixed to the inner side of the outer layer film, the multiple balloons are continuously distributed in the circumferential direction of the outer layer film, an inflation catheter is fixed to one end of the outer layer film, and the inflation catheter is connected with the inflation catheter. A port of the inflation catheter is connected and communicated with the end of each balloon, the balloons are in a sector ring shape after being inflated and expanded, the adjacent side ends of the balloons make contact with each other, and a perfusion flow channel is formed in the center of each balloon. The blood vessel crevasse plugging device has the advantages that the structural design is simple and reasonable, blood vessel crevasses can be effectively and rapidly plugged, blood circulation cannot be blocked in the plugging process, and effective treatment time is provided for critical patients with blood vessel perforation or rupture.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an injectable occluding balloon catheter and a manufacturing process thereof. Background Art

[0002] Clinically, coronary artery perforation is likely to cause pericardial tamponade in patients. In addition, blood vessel rupture can cause severe ischemia in patients' organs, both of which can endanger the patient's life.

[0003] At present, the existing treatment methods are to directly block the blood vessels, and then perform surgery, or use covered stents to block the bleeding site. For cases with minor ruptures, the waiting time from blocking to surgery is generally long, and the long-term lack of blood circulation after blocking will seriously endanger the patient's health and life safety. However, there are also some cases with more serious ruptures. Due to the lack of effective and rapid blocking methods, there may be a problem of not being able to block in time and effectively treat the problem.

[0004] In addition, there is a self-perfusion medicine ball among the existing products. Although it has a flow channel inside, the inner diameter of the flow channel is relatively small, only as thick as the guide wire, and cannot provide effective blood flow conditions.

[0005] Based on this, it is necessary to develop an injectable occluding balloon catheter and its manufacturing process to overcome the above technical problems. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a perfusable occluding balloon catheter and a manufacturing process thereof, which effectively overcomes the defects of the prior art.

[0007] The technical solution of the present invention to solve the above technical problems is as follows:

[0008] A perfusable occluding balloon catheter comprises a tubular and flexible outer membrane and at least two flat balloons fixed on the inner side of the outer membrane, wherein the plurality of balloons are continuously distributed along the circumferential direction of the outer membrane, an inflation catheter is fixed to one end of the outer membrane, a port of the inflation catheter is respectively connected and communicated with the end of each of the balloons, the balloons are all fan-shaped after being inflated, and adjacent side ends are in contact with each other, and a perfusion channel is formed in the center of the balloon.

[0009] Based on the above technical solution, the present invention can also be improved as follows.

[0010] Furthermore, both ends of the outer layer film are provided with developing lines.

[0011] Furthermore, the outer layer film is a PET film.

[0012] Furthermore, the number of the above-mentioned balloons is 2-10.

[0013] Furthermore, the length of the outer layer film is 15-50 mm.

[0014] Furthermore, a branch trachea is connected to the middle of one end of each of the balloons, and one end of the branch trachea is gathered and connected to and communicated with a port at one end of the inflation catheter.

[0015] Furthermore, one end terminal of each of the above-mentioned balloons is respectively connected to a branch trachea, one end of the above-mentioned inflation tube is fitted and fixed to the inner side of one end of the above-mentioned outer membrane, and one end of the above-mentioned branch trachea is respectively extended to connect and communicate with one end port of the above-mentioned inflation tube.

[0016] The beneficial effects are: the structural design is simple and reasonable, and the vascular rupture can be effectively and quickly blocked, and the blocking process will not block the blood circulation, providing effective treatment time for critically ill patients with vascular perforation or rupture.

[0017] Also provided is a process for manufacturing a perfusable occluding balloon catheter, comprising the following steps:

[0018] Step 1: Weaving a rectangular film layer with silk thread, or cutting a rectangular film layer on a finished film;

[0019] Step 2: attaching and fixing at least two rectangular flattened balloons on one side of the membrane layer along the length direction;

[0020] Step 3: Roll the membrane layer into a circular tube shape, and make the balloon inside the membrane layer, and connect and seal the joints of the membrane layer to form an outer membrane;

[0021] Step 4: an inflation catheter is arranged at one end of the outer membrane, and one end of the inflation catheter is connected to one end of each balloon by a pipeline.

[0022] Based on the above technical solution, the present invention can also be improved as follows.

[0023] Furthermore, in the above step three, the joints of the membrane layers are welded by ultrasonic welding.

[0024] Furthermore, two ends of the balloon are close to or flush with two ends of the outer membrane.

[0025] The beneficial effects are: the production process is simple and quick. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a cross-sectional view of the perfusable occluding balloon catheter of the present invention;

[0027] Figure 2 It is a structural schematic diagram of an embodiment of the perfusable occluding balloon catheter of the present invention;

[0028] Figure 3 It is a schematic structural diagram of another embodiment of the perfusable occluding balloon catheter of the present invention.

[0029] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0030] 1. Outer membrane; 2. Balloon; 3. Inflation catheter; 11. Development line; 21. Branch trachea. DETAILED DESCRIPTION

[0031] The principles and features of the present invention are described below in conjunction with the accompanying drawings. The examples given are only used to explain the present invention and are not used to limit the scope of the present invention.

[0032] Example 1

[0033] like Figure 1 , 2 As shown in Figure 3, the perfusable occluding balloon catheter of this embodiment includes a tubular and flexible outer membrane 1 and at least two flat balloons 2 fixed on the inner side of the outer membrane 1, and the plurality of balloons 2 are continuously distributed along the circumferential direction of the outer membrane 1. An inflation catheter 3 is fixed to one end of the outer membrane 1, and the ports of the inflation catheter 3 are respectively connected and communicated with the ends of each of the balloons 2. After being inflated, the balloons 2 are all fan-shaped, and adjacent side ends are in contact with each other. A perfusion channel is formed in the center of the balloon 2.

[0034] The use process of the perfusable occluding balloon catheter of this embodiment is as follows:

[0035] The entire blocking balloon catheter is delivered to the ruptured blood vessel by using a catheter (sheath), and then one end of the catheter (sheath) inflation catheter 3 located outside the body is pushed out. Next, a medium (gas or liquid) is injected through the other end port of the inflation catheter 3 outside the body to inflate the multiple balloons 2. During the filling process, the balloons 2 will squeeze the outer membrane 1 outward, so that the outer membrane 1 fits tightly with the inner wall of the blood vessel at the rupture of the blood vessel, thereby sealing the rupture of the blood vessel. After being filled, the multiple balloons 2 will form an annular capsule body, and a perfusion flow channel for blood circulation will be formed in the middle position of the capsule body. Therefore, the entire blocking balloon catheter can ensure blood circulation while sealing the rupture, providing better treatment conditions for subsequent rupture operations, and allowing doctors to have more sufficient surgical treatment time, greatly reducing surgical risks and improving patients' survival rates.

[0036] After the use of the perfusable occluding balloon catheter of this embodiment, the medium can be removed by using the inflation catheter 3 and the entire catheter can be taken out.

[0037] In this embodiment, a valve is provided at one end of the inflation conduit 3 away from the outer membrane 1 , and the state of the filling medium in the inflation conduit 3 is controlled by the valve.

[0038] As a preferred embodiment, developing lines 11 are provided at both ends of the outer layer film 1 .

[0039] In the above embodiment, the developing line 11 can be developed in an X-ray device to reflect the position of the entire occluding balloon catheter in the patient's body, providing a clear position guide for the treatment process.

[0040] In this embodiment, the outer layer film 1 is a PET film. Of course, other medical grade film materials can also be used.

[0041] In this embodiment, the balloons 2 are provided with 2-10 balloons 2. When in use, multiple balloons 2 can be inflated and deflated at the same time.

[0042] In this embodiment, the length of the outer film 1 is 15-50 mm.

[0043] In this embodiment, the connection structure between the inflation catheter 3 and the balloon 2 can have the following two structural forms:

[0044] 1) If Figure 2 As shown, a branch trachea 21 is connected to the middle of one end of each of the balloons 2 , and one end of the branch trachea 21 is gathered and connected to and communicated with a port at one end of the inflation catheter 3 .

[0045] In the solution 1), one end of the inflation tube 3 is located at the center of one end of the outer membrane 1, and a plurality of branch air tubes 21 gather toward one end of the inflation tube 3 to form gaps for blood to flow through.

[0046] 2) If Figure 3 As shown, one end terminal of each of the balloons 2 is connected to a branch trachea 21, one end of the inflation tube 3 is fixed to the inner side of one end of the outer membrane 1, and one end of the branch trachea 21 is extended to connect and communicate with one end port of the inflation tube 3. In the scheme 2), the inflation tube 3 is fixed to one end of the outer membrane 1, and the multiple branch trachea 21 are extended along the circumferential direction of the outer membrane 1 so as not to block the perfusion flow channel in the center of the balloon 2.

[0047] Example 2

[0048] The manufacturing process of the perfusable occluding balloon catheter of this embodiment comprises the following steps:

[0049] Step 1: Weaving a rectangular film layer with silk thread, or cutting a rectangular film layer on a finished film;

[0050] Step 2: at least two rectangular flattened balloons 2 are fixed on one side of the membrane layer along the length direction;

[0051] Step 3: Roll the film layer into a circular tube shape, and make the balloon 2 inside the film layer, and connect and seal the joints of the film layer to form an outer film 1;

[0052] Step 4: an inflation catheter 3 is arranged at one end of the outer membrane 1, and one end of the inflation catheter 3 is connected to one end of each balloon 2 by a pipeline.

[0053] In this embodiment, the manufacturing method of the occluding balloon catheter is relatively simple and quick. The whole is formed by curling the membrane layer of a strip-shaped attached balloon 2, and the process is very simple.

[0054] In this embodiment, one side of the balloon 2 and one side of the membrane layer can be bonded by using medical colloid, or other conventional fixing methods available on the market.

[0055] In this embodiment, in the above step 3, the joint of the membrane layer is welded by ultrasonic welding. More specifically, after the membrane layer is curled, its two ends can be overlapped inside and outside each other, and then the overlapped part is fixed by ultrasonic welding to form a cylindrical "conduit".

[0056] In this embodiment, the two ends of the balloon 2 are close to or flush with the two ends of the outer membrane 1. That is, in the length direction of the catheter, the two ends of the balloon 2 are basically flush with or close to the two ends of the catheter, and the balloon 2 can effectively cover almost the entire area of ​​the outer membrane 1 after being filled, ensuring that the outer membrane 1 can be squeezed outward and closely fit the blood vessel wall.

[0057] In the description of the present invention, it is to be understood that the terms “center”, “longitudinal”, “lateral”, “length”, “width”, “thickness”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “clockwise”, “counterclockwise”, “axial”, “radial”, “circumferential”, etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0058] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0059] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0060] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0061] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0062] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and vary the above embodiments within the scope of the present invention.

Claims

1. A perfusable occluding balloon catheter, characterized in that: The invention comprises a tubular and flexible outer membrane (1) and at least two flat balloons (2) fixed on the inner side of the outer membrane (1). The plurality of balloons (2) are continuously distributed along the circumferential direction of the outer membrane (1). An inflation catheter (3) is fixed to one end of the outer membrane (1). The ports of the inflation catheter (3) are respectively connected to and communicated with the ends of each of the balloons (2). After being inflated, the balloons (2) are all fan-shaped, and the adjacent side ends are in contact with each other. The center of the balloon (2) forms a perfusion channel.

2. The perfusable occluding balloon catheter according to claim 1, characterized in that: The outer film (1) has developing lines (11) at both ends.

3. The perfusable occluding balloon catheter according to claim 1, characterized in that: The outer layer film (1) is a PET film, or the outer layer film (1) is a silk thread braided component.

4. The perfusable occluding balloon catheter according to claim 1, characterized in that: The number of the balloons (2) is 2 to 10.

5. The perfusable occluding balloon catheter according to claim 1, characterized in that: The length of the outer film (1) is 15-50 mm.

6. The perfusable occluding balloon catheter according to any one of claims 1 to 5, characterized in that: A branch trachea (21) is connected to the middle of one end of each balloon (2), and one end of the branch trachea (21) is gathered together and connected to and communicated with a port at one end of the inflation catheter (3).

7. The perfusable occluding balloon catheter according to any one of claims 1 to 5, characterized in that: One terminal end of each of the balloons (2) is connected to a branch trachea (21), one end of the inflation tube (3) is fixed to the inner side of one end of the outer membrane (1), and one end of the branch trachea (21) extends to connect and communicate with one end port of the inflation tube (3).

8. A process for manufacturing the perfusable occluding balloon catheter according to any one of claims 1 to 7, characterized in that: The following steps are involved: Step 1: Weaving a rectangular film layer with silk thread, or cutting a rectangular film layer on a finished film; Step 2: attaching and fixing at least two rectangular flattened balloons (2) on one side of the membrane layer along the length direction; Step 3: Roll the membrane layer into a circular tube shape, and place the balloon (2) on the inner side of the membrane layer. Connect and seal the joints of the membrane layer to form an outer membrane layer (1); Step 4: an inflation catheter (3) is arranged at one end of the outer membrane (1), and one end of the inflation catheter (3) is connected and communicated with one end of each balloon (2) by means of a pipeline.

9. The manufacturing process of the perfusable occluding balloon catheter according to claim 8, characterized in that: In the step three, the joints of the membrane layers are welded by ultrasonic welding.

10. The manufacturing process of the perfusable occluding balloon catheter according to claim 8, characterized in that: The two ends of the balloon (2) are close to or flush with the two ends of the outer membrane (1).

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