A dual-chamber Milesian sac dilation balloon catheter

Abstract

The present invention discloses a double-lumen Milesian sac dilation balloon catheter, which relates to the technical field of medical devices. It includes a catheter body, a balloon, and a first radiopaque ring. One end of the catheter body is an insertion end, and the other end is an operation end. The catheter body is provided with a first channel and a second channel. The first channel extends from the operation end to the insertion end; the balloon is sleeved on the catheter body, and the balloon is located at the insertion end. The interior of the balloon is communicated with the first channel. The balloon has a first end and a second end axially distributed along the catheter body. The first end faces the insertion end, and the second end is the opposite end of the first end. The second channel extends from the operation end to the second end, and the second channel is communicated with the outside of the balloon; the first radiopaque ring is fixed to the catheter body, and the first radiopaque ring is adjacent to the balloon, and the first radiopaque ring is located at the first end. The double-lumen Milesian sac dilation balloon catheter of the present invention can inject drugs into the Milesian sac after the balloon enters the Milesian sac, meeting the clinical needs.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a double-lumen Meckel's cave dilatation balloon catheter. Background Art

[0002] Primary trigeminal neuralgia refers to paroxysmal severe pain limited to the distribution area of the trigeminal nerve. The treatment methods for primary trigeminal neuralgia mainly include drug treatment, surgical treatment, and other treatments. For patients with primary trigeminal neuralgia who are ineffective in conservative treatments such as drug treatment, surgical treatment should be considered in a timely manner.

[0003] Currently, relatively mature surgical treatment methods in clinical applications include microvascular decompression, percutaneous balloon compression, percutaneous radiofrequency ablation, etc. Among them, the main possible mechanism of percutaneous balloon compression is related to irreversible compression damage to large nerve fibers in the trigeminal ganglion, blocking the nerve conduction of the trigeminal nerve, and the small nerve fibers innervating the cornea are not affected. Therefore, it is particularly suitable for patients mainly affected by the first branch. At the same time, because percutaneous balloon compression has the advantages of short operation time, small trauma, and fast postoperative recovery, it is often the preferred treatment method for elderly patients with severe underlying diseases or those who refuse microvascular decompression.

[0004] However, the current balloon catheter used for percutaneous balloon compression can only dilate the balloon and cannot inject the required drugs into the Meckel's cave, which cannot meet the clinical needs, thereby reducing the efficiency of inserting the balloon catheter into the Meckel's cave and making it difficult to obtain an ideal balloon shape in the Meckel's cave. Summary of the Invention

[0005] The present invention aims to solve at least one of the technical problems existing in the prior art. For this purpose, the present invention provides a double-lumen Meckel's cave dilatation balloon catheter, which can inject drugs into the Meckel's cave after the balloon enters the Meckel's cave to meet the clinical needs.

[0006] The double-lumen Meckel's cave dilatation balloon catheter according to an embodiment of the present invention includes a catheter body. One end of the catheter body is an insertion end, and the other end is an operation end. The catheter body is provided with a first channel and a second channel. The first channel extends from the operation end to the insertion end.

[0007] A balloon, which is sleeved on the catheter body. The balloon is located at the insertion end. The interior of the balloon is communicated with the first channel. The balloon has a first end and a second end axially distributed along the catheter body. The first end faces the insertion end, and the second end is the opposite end of the first end. The second channel extends from the operation end to the second end, and the second channel is communicated with the outside of the balloon.

[0008] The first imaging ring is fixed to the catheter body, and the first imaging ring is adjacent to the balloon. The first imaging ring is located at the first end.

[0009] The double-lumen Meckel's cave dilation balloon catheter according to the embodiment of the present invention has at least the following beneficial effects: The insertion end of the catheter body is used to puncture into the Meckel's cave. The balloon is arranged at the insertion end of the catheter body. After the catheter body punctures to the designated position, the balloon is located in the Meckel's cave. Before the balloon expands, the contrast agent can be injected into the Meckel's cave through the second channel, which is beneficial to observing the situation inside the Meckel's cave. At the same time, the first imaging ring is at the first end of the balloon, which can show the approximate position of the balloon. The balloon can be inflated by injecting liquid through the first channel, and the inflated balloon can compress the large nerve fibers in the trigeminal ganglion, that is, perform percutaneous balloon compression. After the balloon expands, local anesthetic drugs can also be injected through the second channel. The local anesthetic drugs entering the Meckel's cave can improve the patient's tolerance and reduce the trigeminocardiovascular reflex, which is beneficial to the smooth execution of percutaneous balloon compression.

[0010] According to some embodiments of the present invention, a guide wire is arranged in the first channel. The guide wire extends from the operating end to the insertion end. One end of the guide wire is connected to the operating end to limit the axial movement of the guide wire along the first channel, and the other end of the guide wire abuts against the insertion end movably.

[0011] According to some embodiments of the present invention, the guide wire is provided with an elastic structure, and the elastic structure can change the length of the guide wire.

[0012] According to some embodiments of the present invention, the guide wire is provided with a helical section, and the helical section has elasticity. The helical section is the elastic structure.

[0013] According to some embodiments of the present invention, the side of the guide wire abutting against the insertion end is the front end, and the elastic structure is located at the front end of the guide wire.

[0014] According to some embodiments of the present invention, the catheter body is connected with a handle assembly. The handle assembly is located at the operating end. The handle assembly is provided with a first interface and a second interface. The first interface is communicated with the first channel, and the second interface is communicated with the second channel.

[0015] According to some embodiments of the present invention, a fixing ring is arranged at the connection part between the handle assembly and the catheter body.

[0016] According to some embodiments of the present invention, the catheter body is provided with a plurality of liquid outlet holes. The plurality of liquid outlet holes are all communicated with the first channel, and the plurality of liquid outlet holes are located inside the balloon.

[0017] According to some embodiments of the present invention, a second radiopaque ring is fixed to the catheter body, the second radiopaque ring is adjacent to the balloon, and the second radiopaque ring is located at the second end.

[0018] According to some embodiments of the present invention, one side of the first radiopaque ring close to the insertion end is the head, and the head is arc-shaped.

[0019] Additional aspects and advantages of the present invention will be given in part in the following description, become apparent in part from the following description, or be learned through the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention will be further described below in conjunction with the drawings and embodiments, where:

[0021] Figure 1 is a schematic structural diagram of a double-lumen Miles balloon dilation catheter according to an embodiment of the present invention;

[0022] Figure 2 is a cross-sectional view of the insertion end of a double-lumen Miles balloon dilation catheter according to an embodiment of the present invention;

[0023] Figure 3 is a cross-sectional view of the operating end of a double-lumen Miles balloon dilation catheter according to an embodiment of the present invention;

[0024] Figure 4 is a schematic diagram of the cross-section of the balloon and the internal space of the balloon of a double-lumen Miles balloon dilation catheter according to an embodiment of the present invention.

[0025] Reference numerals:

[0026] Catheter body 100, first channel 110, liquid outlet hole 111, second channel 120, balloon 200, first radiopaque ring 300, guide wire 400, helical section 410, handle assembly 500, first interface 510, second interface 520, fixing ring 600, second radiopaque ring 700. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0027] Embodiments of the present invention will be described in detail below. Examples of the embodiments are shown in the drawings, where the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary only for explaining the present invention and should not be construed as limiting the present invention.

[0028] In the description of the present invention, it should be understood that for the orientation description, such as the orientation or positional relationship indicated by up, down, etc., it is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention.

[0029] In the description of the present invention, "a plurality of" refers to more than two. If there is a description of the first and the second, it is only for the purpose of distinguishing technical features, and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features or implicitly indicating the sequence relationship of the indicated technical features.

[0030] In the description of the present invention, unless otherwise clearly defined, terms such as "arrangement", "installation", "connection", etc. should be understood in a broad sense. Those skilled in the art can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific content of the technical solution.

[0031] As described in the background art, the current balloon catheter can only expand the balloon and cannot inject the required drugs into the Meckel's diverticulum, failing to meet the clinical needs. First, if a small amount of contrast agent can be injected into the Meckel's diverticulum after the balloon reaches it, and relevant medical equipment is used for imaging and observation, the position of the balloon in the Meckel's diverticulum can be determined, improving the placement efficiency of the balloon catheter. At the same time, when injecting liquid into the balloon to expand it, the contrast agent in the Meckel's diverticulum can assist in showing the contour of the balloon, helping to feedback information to control the balloon shaping.

[0032] Second, if a small amount of local anesthetic can be injected into the Meckel's diverticulum, the tolerance of the patient can be improved, and the trigeminal cardiovascular reflex can be reduced, which is beneficial to the smooth execution of percutaneous balloon compression.

[0033] Refer to Figure 1 and Figure 2 As shown, a double-lumen Meckel's diverticulum dilation balloon catheter according to an embodiment of the present invention includes a catheter body 100, a balloon 200, and a first imaging ring 300. It should be understood that Figure 1 、 Figure 2 and Figure 4 In, the balloon 200 is in an expanded state, and the shape of the unexpanded balloon 200 is not shown.

[0034] One end of the catheter body 100 is the insertion end, and the other end of the catheter body 100 is the operation end. The catheter body 100 is provided with a first channel 110 and a second channel 120. The first channel 110 extends from the operation end to the insertion end; the balloon 200 is sleeved on the catheter body 100. The balloon 200 is located at the insertion end. The inside of the balloon 200 communicates with the first channel 110. The balloon 200 has a first end and a second end distributed along the axial direction of the catheter body 100. The first end faces the insertion end, and the second end is the opposite end of the first end. The second channel 120 extends from the operation end to the second end, and the second channel 120 communicates with the outside of the balloon 200.

[0035] The insertion end of the catheter body 100 is used to penetrate into the Meckel's cave. It should be understood that the catheter body 100 itself does not have a puncture function. Other medical devices need to be used to perform puncture first to form a microchannel, and the catheter body 100 can enter the Meckel's cave from the microchannel. The approximate position where the catheter body 100 enters the Meckel's cave can be determined by injecting a contrast agent through the second channel 120. The contrast agent is injected from the operation end into the second channel 120 and flows out from the second end. Since the balloon 200 has entered the Meckel's cave, the contrast agent also enters the Meckel's cave after flowing out from the second end. At this time, relevant medical equipment can be used to perform imaging to observe the situation inside the Meckel's cave, further determine the position of the balloon in the Meckel's cave, so as to make minor adjustments and improve the placement efficiency of the balloon.

[0036] It should be understood that the first imaging ring 300 is fixed to the catheter body 100, and the first imaging ring 300 is adjacent to the balloon 200. The first imaging ring 300 is located at the first end. The first imaging ring 300 is used to assist in determining the position of the balloon 200. Since the first imaging ring 300 is located at the first end of the balloon 200, the position of the first imaging ring 300 can be understood as the edge position of the balloon 200. It should be understood that the materials of the balloon 200 and the catheter body 100 are made of non-imaging materials. Therefore, the first imaging ring 300 is needed to assist in determining the position of the balloon 200. The non-imaging material here generally refers to a material that can transmit X-rays. After the X-rays pass through the above materials, they will not be developed on the film.

[0037] When it is determined that the balloon 200 reaches the designated position, liquid can be injected into the inside of the balloon 200 through the first channel 110 to expand the balloon 200. The expanded balloon 200 compresses the large nerve fibers in the trigeminal ganglion, and the percutaneous balloon compression operation is completed. When the balloon 200 expands and compresses the large nerve fibers in the trigeminal ganglion, a certain duration needs to be maintained to cause irreversible compression damage to the large nerve fibers in the trigeminal ganglion. Therefore, after the balloon 200 expands, local anesthetic drugs can also be injected through the second channel 120. The local anesthetic drugs enter the Meckel's cave through the second channel 120, which can improve the patient's tolerance and reduce the trigeminocardiovascular reflex, ensuring that the percutaneous balloon compression operation can be smoothly performed.

[0038] Further, during the process of inserting the catheter body 100 into the Meckel's diverticulum, there may be a situation where the previously punctured channel is relatively small, or for other reasons, it is difficult to insert the catheter body 100. At this time, a wire can be used as a guiding structure. The wire is inserted into the first channel 110, and the wire will abut against the extending end. Thus, applying an external force to the wire can assist the catheter body 100 to continue moving in the puncture channel to the Meckel's diverticulum. However, during the process of inserting the wire into the first channel 110, the wire will also occupy the space of the first channel 110, and it may cause the liquid or air in the first channel 110 to be squeezed into the balloon 200, resulting in a slight premature expansion of the balloon 200. When the balloon 200 has not entered the Meckel's diverticulum, the expanded balloon 200 will instead hinder the movement of the catheter body 100. Therefore, when introducing the wire, it is necessary to drain the liquid or gas in the balloon 200, and this step needs to be repeated until the balloon 200 no longer expands before it can pass through the puncture channel. The above steps are very cumbersome and affect the operation efficiency of the surgery. It should be understood that the puncture channel can be a puncture needle sheath.

[0039] Further, to solve the above problems, it can be understood that a guide wire 400 is provided in the first channel 110. The guide wire 400 extends from the operating end to the extending end. One end of the guide wire 400 is connected to the operating end to limit the axial movement of the guide wire 400 along the first channel 110, and the other end of the guide wire 400 abuts against the extending end movably.

[0040] The guide wire 400 is pre - arranged in the first channel 110. During the process of inserting the catheter body 100 into the Meckel's diverticulum, if there is an obstruction, an external force can be directly applied to the guide wire 400 without the need to re - insert the guide wire 400 into the first channel 110. Since the guide wire 400 already exists in the first channel 110, applying an external force to the guide wire 400 will not cause the liquid or gas in the first channel 110 to be squeezed towards the balloon 200, and the balloon 200 will not expand either. One end of the guide wire 400 is connected to the operating end, which can prevent the guide wire 400 from slipping out of the first channel 110 and at the same time limit the axial movement of the guide wire 400 along the first channel 110. The side of the guide wire 400 located at the extending end is not fixed and is in movable abutment, which can reduce the accidental operation that causes the guide wire 400 to withdraw towards the operating end and the catheter body 100 to move outwards. It should be understood that the guide wire 400 is preferably made of a metal material and has a certain rigidity. Applying an external force to the guide wire 400 can push the catheter body 100 towards the Meckel's diverticulum. For example, the guide wire 400 can be a guide steel wire.

[0041] It can be understood that the guide wire 400 is provided with an elastic structure, and the elastic structure can change the length of the guide wire 400.

[0042] When an external force is applied to the guide wire 400, if the applied force is too large, the catheter body 100 may touch the tissue part of the patient. If the guide wire 400 is provided with an elastic structure and the elastic structure can change the length of the guide wire 400, when the catheter body 100 touches the tissue part, the guide wire 400 can shorten its length and store energy in the elastic structure.

[0043] It should be understood that if the external force applied to the guide wire 400 is too large, after the catheter body 100 passes through a part with greater resistance, due to the slow reaction of people, the guide wire 400 will continue to move forward, resulting in the rapid movement of the catheter body 100 to touch the tissue part of the patient, and in severe cases, it will cause damage to the patient's brain tissue.

[0044] The added elastic structure enables the guide wire 400 to shorten and absorb energy. When the catheter body 100 touches the tissue part of the patient, the elastic structure shortens the guide wire 400, reducing the force exerted by the catheter body 100 on the patient's tissue part and the time of the acting force. At the same time, when the doctor operates the guide wire 400, he can feel the elastic structure contracting and absorbing energy, so as to make a reaction to reduce the acting force applied to the guide wire 400.

[0045] Refer to Figure 2 As shown, it can be understood that the guide wire 400 is provided with a helical section 410, and the helical section 410 has elasticity, and the helical section 410 is the elastic structure.

[0046] The helical section 410 is an elastic structure. A part of the guide wire 400 is made into the helical section 410. The helical section 410 can play a role similar to that of a spring, that is, it has an elastic structure to absorb energy and can change the length of the guide wire 400.

[0047] It can be understood that the end of the guide wire 400 abutting against the insertion side is the front end, and the elastic structure is located at the front end of the guide wire 400. In some specific embodiments, the helical section 410 is located at the front end of the guide wire 400. The helical section 410 is an elastic structure and can contract and absorb energy. Setting the helical section 410 at the front end of the guide wire 400 or at a position close to the front end of the guide wire 400 has a faster response speed. Since the guide wire 400 is provided with the helical section 410, the helical section 410 will divide the guide wire 400 into a first section and a second section. The side close to the insertion end is defined as the first section. The helical section 410 is closer to the front end of the guide wire 400. Then, the smaller the length of the first section, the smaller the deflection angle between the first section and the first channel 110 under the action of the external force of the guide wire 400. Preferably, the length of the first section is zero, that is, the helical section 410 is completely located at the front end of the guide wire 400. Further, the distance between the first end and the second end of the balloon 200 is L, then the length of the helical section 410 is preferably 1 / 2L.

[0048] Refer toFigure 3 As shown, it can be understood that the catheter body 100 is connected to a handle assembly 500. The handle assembly 500 is located at the operating end. The handle assembly 500 is provided with a first interface 510 and a second interface 520. The first interface 510 communicates with the first channel 110, and the second interface 520 communicates with the second channel 120.

[0049] The handle assembly 500 facilitates the doctor to hold and operate the catheter body 100. Preferably, the first interface 510 can be set as an injection seat for the dilation channel, and the second interface 520 can be set as an injection seat for the injection channel. The injection seat for the dilation channel can be an independent Luer female connector.

[0050] Furthermore, the handle assembly 500 can be set as a Y-shaped structure. The tail end of the Y-shaped structure is used to connect to the catheter body 100. The head end of the Y-shaped structure is respectively a first part and a second part that cross each other. Among them, the first interface 510 can be set on the first part, and the second interface 520 can be set on the second part, and the two do not interfere with each other.

[0051] It can be understood that a fixing ring 600 is provided at the connection between the handle assembly 500 and the catheter body 100.

[0052] The fixing ring 600 can be used to fix the handle assembly 500 to the surgical sterile drape, reducing the risk of accidental detachment of the handle assembly 500 or the catheter body 100 during the dilation operation of the balloon 200.

[0053] Referring to Figure 4 As shown, it can be understood that the catheter body 100 is provided with a plurality of liquid outlet holes 111. The plurality of liquid outlet holes 111 are all communicated with the first channel 110, and the plurality of liquid outlet holes 111 are located inside the balloon 200.

[0054] The plurality of liquid outlet holes 111 can allow the liquid to enter the inside of the balloon 200 evenly, reducing the risk of uneven dilation of the balloon 200. Preferably, the plurality of liquid outlet holes 111 can be arranged along the axial direction of the catheter body 100. At the same time, they can further be distributed circumferentially around the catheter body 100, or be spirally distributed along both the axial and circumferential directions. The number of the liquid outlet holes 111 can be selectively set to 3 - 5.

[0055] Referring to Figure 2 Or Figure 4 As shown, it can be understood that a second imaging ring 700 is fixed to the catheter body 100. The second imaging ring 700 is adjacent to the balloon 200, and the second imaging ring 700 is located at the second end.

[0056] The second developing ring 700 can cooperate with the first developing ring 300. That is, the balloon 200 is located between the first developing ring 300 and the second developing ring 700. Therefore, by judging the positions of the first developing ring 300 and the second developing ring 700, the position of the balloon 200 in the Meckel's diverticulum can be determined.

[0057] The cooperation between the first developing ring 300 and the second developing ring 700 can also assist in judging the position of the balloon 200 and the position of local anesthetic injection in the Meckel's diverticulum after Meckel's diverticulum imaging. Specifically, the second channel 120 extends from the operating end to the second end, that is, to the position of the second developing ring 700. The outlet of the second channel 120 is located at the second developing ring 700. Judging the position of the second developing ring 700 can know the injection position of the local anesthetic.

[0058] It can be understood that the side of the first developing ring 300 close to the insertion end is the head, and the head is arc-shaped.

[0059] Since the first developing ring 300 is arranged at the insertion end, when the catheter body 100 penetrates into the Meckel's diverticulum, the first part in contact with the patient is the first developing ring 300. The arc-shaped first developing ring 300 can reduce the damage to the patient's tissue and also reduce the pain of the patient.

[0060] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those of ordinary skill in the art, various changes can be made without departing from the purpose of the present invention.

Claims

1. A double-lumen Myers' pouch dilatation balloon catheter, characterized in that, Comprising: A catheter body (100), one end of the catheter body (100) being an insertion end, the other end of the catheter body (100) being an operating end, the catheter body (100) being provided with a first channel (110) and a second channel (120), the first channel (110) extending from the operating end to the insertion end; A balloon (200), the balloon (200) being sleeved on the catheter body (100), the balloon (200) being located at the insertion end, the interior of the balloon (200) being in communication with the first channel (110), the balloon (200) having a first end and a second end axially distributed along the catheter body (100), the first end facing the insertion end, the second end being the opposite end of the first end, the second channel (120) extending from the operating end to the second end, the second channel (120) being in communication with the exterior of the balloon (200); A first radiopaque ring (300), the first radiopaque ring (300) being fixed to the catheter body (100) and adjacent to the balloon (200), the first radiopaque ring (300) being located at the first end; Wherein, a guide wire (400) is provided in the first channel (110), the guide wire (400) extending from the operating end to the insertion end, one end of the guide wire (400) being connected to the operating end to limit axial movement of the guide wire (400) along the first channel (110), the other end of the guide wire (400) being movably abutted against the insertion end, the guide wire (400) being provided with an elastic structure capable of changing the length of the guide wire (400).

2. The double-lumen Miles sac dilation balloon catheter according to claim 1, wherein, The guide wire (400) is provided with a helical section (410), and the helical section (410) has elasticity, the helical section (410) being the elastic structure.

3. The double-chamber Myers sac dilation balloon catheter according to claim 1, characterized in that, The side of the guide wire (400) abutting against the insertion end is the front end, and the elastic structure is located at the front end of the guide wire (400).

4. The double-chamber Myers bursa dilation balloon catheter according to claim 1, wherein, The catheter body (100) is connected with a handle assembly (500), the handle assembly (500) being located at the operating end, the handle assembly (500) being provided with a first interface (510) and a second interface (520), the first interface (510) being in communication with the first channel (110), the second interface (520) being in communication with the second channel (120).

5. The double-chamber Myers capsule dilation balloon catheter according to claim 4, wherein, A fixing ring (600) is provided at the connection between the handle assembly (500) and the catheter body (100).

6. The double-chamber Milesian sac dilation balloon catheter according to claim 1, characterized in that The catheter body (100) is provided with a plurality of liquid outlet holes (111), the plurality of liquid outlet holes (111) all being in communication with the first channel (110), and the plurality of liquid outlet holes (111) being located inside the balloon (200).

7. The double-chamber Myers sac dilation balloon catheter according to claim 1, characterized in that, A second radiopaque ring (700) is fixed to the catheter body (100), the second radiopaque ring (700) being adjacent to the balloon (200), the second radiopaque ring (700) being located at the second end.

8. The double-lumen Myers bursa dilation balloon catheter according to claim 1, characterized in that, The side of the first radiopaque ring (300) close to the insertion end is the head, and the head is arc-shaped.

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