Fistula balloon dilatation catheter

Abstract

The present application relates to the field of medical device technology and discloses a fistula balloon dilatation catheter. The fistula balloon dilatation catheter comprises: a tube body, a puncture needle, and a balloon head. The tube body comprises a catheter, which is provided with a guide channel; the puncture needle is elastically assembled in the guide channel and can be extended and retracted along the guide channel; the balloon head is connected to the distal end of the catheter and is provided with a balloon channel and an inflation chamber; the balloon head can be elastically compressed and reset after compression. When the balloon head is not compressed, the needle tip of the puncture needle is accommodated in the balloon head. When the balloon head is compressed, the puncture needle can be pushed by an external force and the needle tip can be extended from the balloon head along the balloon channel. The beneficial effect is that it can effectively prevent the distal end of the balloon dilatation catheter from puncturing or scratching the patient's brain tissue, making the surgical operation process safe.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a fistula balloon dilatation catheter. Background Art

[0002] Obstructive hydrocephalus is a common neurosurgical disease in clinical practice. It is caused by obstruction of the cerebrospinal fluid circulation pathway, which prevents cerebrospinal fluid from entering the cerebellomedullary cisterna or subarachnoid space. The main manifestations are intellectual disability, dizziness and vomiting, decreased vision, headache, and lower limb weakness. It may be followed by brain atrophy, which seriously threatens the patient's life and health. In the past, the surgical treatment of hydrocephalus was mainly shunt surgery, among which ventriculoperitoneal shunt is suitable for communicating and non-communicating hydrocephalus. The surgical effect is definite, which can effectively release cerebrospinal fluid, relieve intracranial pressure, and help improve clinical symptoms. However, the limitations of ventriculoperitoneal shunt are that there are many postoperative complications, easy recurrence, low patient tolerance, and because the shunt tube can be touched subcutaneously, it may cause psychological problems in some young patients, which is not conducive to improving the prognosis.

[0003] As endoscopic technology continues to mature, ventriculoscopy is increasingly being used in neurosurgery, and its effectiveness has been clinically recognized. Ventriculoscopy-assisted third ventriculostomy is a minimally invasive procedure that is simple, requires a small incision, and causes minimal damage to the patient. It also requires no implants, has minimal impact on surrounding organs, and facilitates postoperative recovery.

[0004] Complications of third ventriculostomy surgery primarily include intraoperative venous bleeding, basilar artery rupture, postoperative intracranial hemorrhage, and infection. Currently used balloon dilatation catheters lack a buffer structure at the distal end used to enter tissue, increasing the risk of brain tissue scratches during surgery. This hinders the physician's ability to safely perform the procedure, leading to a series of surgical complications, hindering recovery, and reducing patients' quality of life. Summary of the Invention

[0005] Based on this, in response to the above problems, the present invention proposes a fistula balloon dilatation catheter to solve at least some of the problems existing in traditional fistula balloon dilatation catheters.

[0006] In order to solve the above technical problems, an embodiment of the present application provides a fistula balloon dilatation catheter, which includes: a tube body, the tube body includes a catheter, and the catheter is provided with a guide channel; a puncture needle, the puncture needle is elastically assembled in the guide channel and can be extended and retracted along the guide channel; a balloon head, connected to the distal end of the catheter and provided with a balloon channel and an expansion cavity; the balloon head can be elastically compressed and reset after compression, when the balloon head is not compressed, the needle head of the puncture needle is accommodated in the balloon head, and when the balloon head is compressed, the puncture needle can be pushed by an external force and the needle head can be extended from the balloon head along the balloon channel.

[0007] In some embodiments, the catheter is further provided with an injection channel and an exhaust channel, and the guide channel, the injection channel and the exhaust channel are independently arranged; the proximal end of the puncture needle extends out of the proximal end hole of the catheter, and the distal end of the puncture needle extends out of the distal end hole of the catheter, and the proximal end hole and the distal end hole are the two end holes connected to the guide channel; the balloon head forms an expansion cavity at the distal end of the catheter that connects the injection channel and the exhaust channel.

[0008] In some embodiments, the balloon head includes a pressure tube, a balloon and a buffer spring; wherein, the pressure tube is movably sleeved on the distal end of the puncture needle; the distal end of the balloon is sealed and sleeved on the pressure tube, and the proximal end of the balloon is sealed and sleeved on the distal end of the catheter, forming the expansion cavity; the buffer spring can be compressed and accommodated in the expansion cavity, elastically connecting the pressure tube and the catheter.

[0009] In some embodiments, the balloon head further comprises a press buckle, and the balloon head is crimped and fixed to the distal end of the catheter by the press buckle.

[0010] In some embodiments, the tube body also includes a four-way tube, which includes a connecting tube, a conducting tube, an injection tube and an exhaust pipe; wherein the connecting tube and the conducting tube are coaxially arranged; the four-way tube is connected to the proximal end of the catheter with the connecting tube, connected to the guide channel through the conducting tube, connected to the injection channel through the injection tube, and connected to the exhaust channel through the exhaust pipe.

[0011] In some embodiments, the four-way tube is also provided with a sealing end cover and a sealing ring; the sealing end cover is detachably assembled on the tube mouth of the conducting tube, and the sealing ring is assembled between the tube mouth of the conducting tube and the sealing end cover to form a sealed connection between the puncture needle and the conducting tube.

[0012] In some embodiments, the puncture needle is provided with a return spring, the distal end of the guide channel is protruded with a first limit ring, and the distal end of the puncture needle is protruded with a second limit ring; the distal end of the guide channel refers to the end of the distal end hole of the guide channel close to the catheter; the second limit ring is in the distal direction of the first limit ring, and the return spring is assembled at the distal end of the puncture needle and is located between the first limit ring and the second limit ring, and the two ends are respectively connected to the first limit ring and the second limit ring. When the puncture needle extends forward, the return spring is stretched to generate a return tension; or, the first limit ring is in the distal direction of the second limit ring, and the return spring is assembled at the distal end of the puncture needle and is located between the first limit ring and the second limit ring, and the two ends are respectively connected to the first limit ring and the second limit ring. When the puncture needle extends forward, the return spring is compressed to generate a return elastic force.

[0013] In some embodiments, the proximal end of the puncture needle is configured as an indicator rod marked with scale values.

[0014] In some embodiments, the puncture needle is further provided with a handle, and the handle is fixed to the proximal end of the puncture needle.

[0015] In some embodiments, the distal end of the balloon covers the entire compression tube, and when the buffer spring is compressed to the maximum extent, the needle tip of the puncture needle is flush with the distal opening of the compression tube or extends out by a preset length when not pushed.

[0016] The present application sets a balloon head at the distal end of the fistula balloon dilatation catheter, and the balloon head wraps the needle head of the puncture needle to form a soft head of the fistula balloon dilatation catheter, so that the distal end of the fistula balloon dilatation catheter can first contact the brain tissue through the balloon head after entering the skull, which can effectively prevent the distal end of the fistula balloon dilatation catheter from puncturing or scratching the patient's brain tissue after entering the patient's skull, thereby ensuring the safety of the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] One or more embodiments are exemplarily illustrated by corresponding drawings, which do not constitute limitations on the embodiments. Elements with the same reference numerals in the drawings are represented as similar elements, and unless otherwise stated, the figures in the drawings do not constitute proportional limitations.

[0018] Figure 1 Schematic diagram of the structure of the fistula balloon dilatation catheter provided in an embodiment of the present application;

[0019] Figure 2 This is a schematic diagram of the catheter structure provided by an embodiment of the present application;

[0020] Figure 3 yes Figure 2 A schematic cross-sectional view of the catheter at XX;

[0021] Figure 4 is a cross-sectional schematic diagram of the balloon head provided in an embodiment of the present application, showing a state where the balloon head is not compressed;

[0022] Figure 5 is a cross-sectional schematic diagram of the balloon head provided in an embodiment of the present application, showing the state of the balloon head when being compressed;

[0023] Figure 6 is a cross-sectional schematic diagram of the balloon head provided in an embodiment of the present application, showing a state where the puncture needle extends out of the balloon channel;

[0024] Figure 7 is a schematic structural diagram of a balloon head provided in an embodiment of the present application, showing a state where the balloon head is not compressed;

[0025] Figure 8 1 is a schematic structural diagram of a balloon head provided in an embodiment of the present application, showing the state of the balloon head when inflated and expanded;

[0026] Figure 9 is a cross-sectional schematic diagram of a four-way tube provided in an embodiment of the present application, showing the assembled state of the four-way tube on a fistula balloon dilatation catheter;

[0027] Figure 10 This is a schematic diagram of the use of the fistula balloon dilatation catheter provided in an embodiment of the present application.

[0028] Description of reference numerals:

[0029] 100. Fistula balloon dilatation catheter; 10. Catheter; 11. Guide channel; 111. Proximal end hole; 112. Distal end hole; 12. Infusion channel; 121. Infusion port; 122. Drain port; 13. Exhaust channel; 131. Infusion port; 132. Exhaust port; 14. First limiting ring; 20. Puncture needle; 21. Return spring; 22. Second limiting ring; 23. Indicator rod; 24. Handle; 30. Balloon head; R30. Balloon Channel; 31. Pressure tube; 311. Third limiting ring; 32. Balloon; 33. Buffer spring; 34. Press buckle; 40. Four-way tube; 41. Connecting tube; 42. Guide tube; 43. Infusion tube; 44. Exhaust pipe; 45. Sealing end cap; 46. Sealing ring; 441. One-way one-way valve; 200. Syringe; 300. Ventriculoscope; 310. Guide channel; A. Ventricle; B. Third ventricle; C. Floor membrane of the third ventricle; D. Basilar artery. DETAILED DESCRIPTION

[0030] The present application is described in detail below with reference to specific embodiments. It should be emphasized that the following description is merely illustrative and is not intended to limit the scope of the present application and its applications.

[0031] It should be noted that, unless otherwise expressly specified or limited, the terms "center," "longitudinal," "lateral," "upper," "lower," "vertical," "horizontal," "inner," "outer," and the like used in this specification to indicate orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings and are intended only to facilitate the description of this application and simplify the description. They are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting this application. Terms such as "mounted," "connected," "connected," and "fixed" should be understood broadly. For example, they can mean fixed, detachable, or integrally connected; mechanically or electrically connected; directly or indirectly through an intermediary. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features indicated. Therefore, features defined as "first" or "second" may explicitly or implicitly include one or more of such features; "plurality" means two or more; and "and / or" includes any and all combinations of one or more of the relevant listed items. For those skilled in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0032] like Figure 1 The fistula balloon dilatation catheter 100 provided in this application includes: a tube body, a puncture needle 20 and a balloon head 30.

[0033] like Figure 2 and Figure 4 The tube body includes a catheter 10 , which is provided with a proximal end hole 111 and a distal end hole 112 , and a guide channel 11 communicating with the proximal end hole 111 and the distal end hole 112 .

[0034] The puncture needle 20 is elastically mounted within the guide channel 11. The proximal end of the puncture needle 20 extends out of the proximal end hole 111 of the catheter 10, and the distal end of the puncture needle 20 extends out of the distal end hole 112 of the catheter 10. In other words, the puncture needle 20 can be extended distally along the guide channel 11 under the force of an external force F, and can be retracted proximally along the guide channel 11 after the force F is removed.

[0035] The balloon head 30 is fixedly connected to the distal end of the catheter 10 and is provided with a balloon channel R30 communicating with the guide channel 11 .

[0036] The balloon head 30 can be elastically compressed and reset after compression: when the balloon head 30 is not compressed (or the puncture needle 20 is not pushed by the external force F), the needle tip of the puncture needle 20 is housed in the balloon head 30 (or the balloon channel R30); when the balloon head 30 touches the obstacle surface (or the puncture needle 20 is pushed by the external force F), it can be elastically compressed, and the needle tip of the puncture needle 20 can be exposed outside the balloon head 30 along the balloon channel R30; and, after the balloon head 30 is no longer in contact with the obstacle surface (or after the external force F acting on the puncture needle 20 is withdrawn), it can be elastically reset, and the needle tip of the puncture needle 20 can be retracted into the balloon head 30 along the balloon channel R30.

[0037] It should be noted that in the medical industry, the two ends of needle-shaped and tubular medical devices are usually referred to as the proximal end and the distal end, where the proximal end refers to the end close to the operator, and the distal end refers to the other end away from the operator.

[0038] The present application provides a balloon head 30 at the distal end of the fistula balloon dilatation catheter 100, which can be elastically compressed when encountering an obstacle and elastically reset when the contact with the obstacle is released. This can effectively prevent the operator from puncturing or scratching the patient's brain tissue with the distal end of the fistula balloon dilatation catheter 100 during the operation on the patient's brain using the fistula balloon dilatation catheter 100, thereby ensuring the safety of the operation.

[0039] like Figure 2 and Figure 3 The catheter 10 also includes an injection channel 12 and an exhaust channel 13. The guide channel 11, the injection channel 12, and the exhaust channel 13 are independently configured. The balloon head 30 is elastically connected to the distal end of the catheter 10, forming an expansion chamber at the distal end of the catheter 10 that connects the injection channel 12 and the exhaust channel 13.

[0040] Specifically, the catheter 10 can be a tubular component with both ends open and a hollow interior. The hollow interior portion of the catheter 10 forms a main channel having a radial dimension larger than that of the puncture needle 20, and this main channel serves as a guide channel 11. At least two secondary channels can be defined along the wall of the catheter 10 from the proximal end toward the distal end of the length of the catheter 10. One of the secondary channels serves as an injection channel 12, and the other serves as an exhaust channel 13.

[0041] Alternatively, in some embodiments, the internal hollow portion of the catheter 10 is provided with a partition (not shown in the figure) extending from the proximal end along the length direction of the catheter 10 to the distal end, and the partition divides the internal hollow portion of the catheter 10 into at least three, forming at least three relatively independently arranged channels, wherein the radial dimension of the first channel is set to be larger than the radial dimension of the puncture needle 20, and is used as a guide channel 11, the second channel is used as an injection channel 12, and the third channel is used as an exhaust channel 13.

[0042] Please continue reading Figure 2 The injection channel 12 is provided with an injection port 121 and a discharge port 122. The injection port 121 can be provided on the end surface and / or side wall of the proximal end of the catheter 10 to allow external filling liquid to be infused into the injection channel 12; the discharge port 122 can be provided on the end surface and / or side wall of the distal end of the catheter 10 to allow the filling liquid in the injection channel 12 to be discharged into the expansion cavity.

[0043] The exhaust channel 13 is provided with an inlet 131 and an exhaust port 132. The inlet 131 can be provided on the distal end surface and / or side wall of the catheter 10 to allow the filling liquid and / or gas inside the balloon tip 30 to be infused into the exhaust channel 13; the exhaust port 132 can be provided on the proximal end surface and / or side wall of the catheter 10 to allow the filling liquid and / or gas inside the exhaust channel 13 to be discharged.

[0044] The present application provides an exhaust channel 13 in the catheter 10 that can connect the balloon head 30 and the injection channel 12. After the external filling liquid is injected into the balloon head 30 through the injection channel 12, the gas in the balloon head 30 can be discharged through the exhaust channel 13. Compared with the existing fistula balloon dilatation catheter that does not have an exhaust channel, the fistula balloon dilatation catheter 100 provided by the present application is beneficial to reducing the operator's preoperative preparation work and effectively avoiding the rupture of the balloon 32 during use of the fistula balloon dilatation catheter 100 due to incomplete discharge of the gas in the balloon 32.

[0045] like Figure 4 The distal end of the puncture needle 20 may be sheathed with a return spring 21, which is used to provide an elastic return force to the puncture needle 20. The puncture needle 20 is elastically assembled within the guide channel 11 of the catheter 10 via the return spring 21. When the puncture needle 20 is driven by an external force F, it can extend forward along the guide channel 11 and out of the balloon channel R30. At the same time, the return spring 21 accumulates elastic potential energy to generate a return force. When the external force F acting on the puncture needle 20 is removed, the return force of the return spring 21 can return the needle to its natural state, free from the external force F.

[0046] Furthermore, the distal end of the guide channel 11 may be provided with a first limiting ring 14, and the distal end of the puncture needle 20 may be provided with a second limiting ring 22, and the second limiting ring 22 is arranged to be closer to the distal end than the first limiting ring 14. The reset spring 21 is sleeved on the distal end of the puncture needle 20, located between the first limiting ring 14 and the second limiting ring 22, and the two ends can be connected to the first limiting ring 14 and the second limiting ring 22 respectively by using glue or other suitable structures, so that the puncture needle 20 is elastically connected to the guide channel 11. During the actual operation of the fistula balloon dilatation catheter 100, when the puncture needle 20 is extended in the distal direction by the external force F, the reset spring 21 is stretched, thereby generating a reset tension, so that the puncture needle 20 can be retracted and reset under the action of the reset tension after the external force F is removed. It should be noted that the distal end of the guide channel 11 refers to the end of the guide channel 11 close to the distal end hole 112 of the catheter 10.

[0047] Alternatively, in some embodiments, the first limiting ring 14 can also be arranged to be closer to the distal end than the second limiting ring 22, and the return spring 21 is assembled at the distal end of the puncture needle 20, located between the first limiting ring 14 and the second limiting ring 22, and the two ends can be connected to the first limiting ring 14 and the second limiting ring 22 respectively by using glue or other suitable structures, so that the puncture needle 20 is elastically connected to the guide channel 11. During the actual operation of the fistula balloon dilatation catheter 100, when the puncture needle 20 is extended in the distal direction by the external force F, the return spring 21 is compressed, and the return spring 21 generates a return elastic force. After the external force F acting on the puncture needle 20 is removed, the puncture needle 20 can be retracted and reset under the action of the return elastic force.

[0048] Please continue reading Figure 4 The balloon head 30 is provided with a balloon channel R30, through which the balloon head 30 is movably sleeved on the needle head of the puncture needle 20, so that the needle head of the puncture needle 20 can be hidden and accommodated in the balloon channel R30 when the fistula balloon dilatation catheter 100 is not in use. Figure 5 When the balloon head 30 contacts the obstacle surface, the balloon head 30 may be elastically compressed. Figure 6 As the force is continued to be applied, the needle head of the puncture needle 20 can extend outward from the balloon channel R30. After the balloon head 30 is released from contact with the obstacle surface and the puncture needle 20 is released, the balloon head 30 can be elastically reset, and the needle head of the puncture needle 20 can be retracted inward into the balloon channel R30 (as shown in FIG. Figure 4 ).

[0049] The present application sets a balloon head 30 at the distal end of the fistula balloon dilatation catheter 100, and the balloon head 30 wraps the needle head of the puncture needle 20 to form a soft head of the fistula balloon dilatation catheter 100, so that the distal end of the fistula balloon dilatation catheter 100 can first contact the brain tissue through the balloon head 30 after entering the skull, which can effectively prevent the distal end of the fistula balloon dilatation catheter 100 from puncturing or scratching the patient's brain tissue after entering the patient's skull, thereby ensuring the safety of the surgical operation.

[0050] Furthermore, the balloon head 30 includes a pressure tube 31, a balloon 32, and a buffer spring 33. The pressure tube 31 is movably sleeved on the distal end of the puncture needle 20. The two ends of the balloon 32 are open and the interior is hollow. The distal end of the balloon 32 is sealed and sleeved on the pressure tube 31, and the proximal end of the balloon 32 is sealed and sleeved on the distal end of the catheter 10. An expansion cavity is formed at the distal end that can communicate with the injection channel 12 and the exhaust channel 13 and can accommodate liquid. The buffer spring 33 can be compressed under the drive of an external force. The buffer spring 33 is accommodated in the expansion cavity, and its two ends are elastically connected to the proximal end of the pressure tube 31 and the distal end of the catheter 10, so that an elastic connection is formed between the pressure tube 31 and the catheter 10.

[0051] Furthermore, the pressure tube 31 can be made of stainless steel. The pressure tube 31 can be a tubular component with both ends open and a hollow interior. A third retaining ring 311 can be protruding from the inner wall of the pressure tube 31, near its proximal end. The inner diameter of the third retaining ring 311 is configured to be smaller than the outer diameter of the second retaining ring 22. This allows the second retaining ring 22 of the puncture needle 20 to abut against the pressure tube 31, thereby limiting further extension of the puncture needle 20 through the third retaining ring 311. Furthermore, to ensure the seal of the distal end of the fistula balloon dilatation catheter 100, the mating locations between the puncture needle 20, the pressure tube 31, and the catheter 10 can all be sealed to prevent leakage of the filling liquid through the mating gap.

[0052] The distal end of the balloon 32 is configured to cover the entire compression tube 31. This design allows the buffer spring 33 to be compressed to its maximum extent and, when the puncture needle 20 is not pushed by an external force F, the needle tip of the puncture needle 20 can be flush with the distal opening of the compression tube 31 or extend a predetermined length. It should be noted that the proximal end of the compression tube 31 refers to the end of the compression tube 31 that is close to the distal end of the catheter 10. Accordingly, for ease of description, the end of the compression tube 31 that is away from the catheter 10 is referred to as the distal end of the compression tube 31 in this application specification.

[0053] For ease of description, this specification refers to the opening of the balloon 32 near the distal end of the catheter 10 as the proximal opening, and the opening of the balloon 32 near the proximal end of the pressure tube 31 as the distal opening of the balloon 32. The distal opening of the balloon 32 can be sealed onto the distal surface of the pressure tube 31 using medical glue, and the proximal opening of the balloon 32 can also be sealed onto the distal surface of the catheter 10 using medical glue, thereby forming an expansion chamber at the distal end of the fistula balloon dilation catheter 100 that is simultaneously in communication with the injection channel 12 and the exhaust channel 13.

[0054] The balloon 32 may be made of a medical balloon glue having elastic properties. For example, in some embodiments, the balloon 32 may be made of a nylon material or a polyethylene terephthalate (PET) material.

[0055] like Figure 7 The elastic deformation of the two sides of the balloon 32 near the two end openings can be designed to be stronger than the elastic deformation of the middle part between the two ends, so that the balloon 32 appears as follows when it is filled. Figure 8 The shape shown is bulging at the sides and contracting in the middle, such as a pear, gourd, or kidney.

[0056] The buffer spring 33 is housed in the expansion cavity and can be compressed under external force. Its two ends can be bonded and fixed to the outer surface of the proximal end of the pressure tube 31 and the outer surface of the distal end of the catheter 10 respectively by using medical glue to elastically connect the pressure tube 31 and the catheter 10, so that the balloon head 30 is elastically connected to the distal end of the catheter 10, ensuring the softness of the balloon head 30 and reducing the stimulation of the brain tissue caused by the distal end of the fistula balloon dilation catheter 100 after entering the skull.

[0057] See also Figure 4 In order to strengthen the connection between the balloon head 30 and the catheter 10, the balloon 32 can be further crimped and fixed to the distal end of the catheter 10 by using a press buckle 34 to prevent the balloon head 30 from accidentally falling off from the catheter 10 during the surgical operation. Specifically, the press buckle 34 can be made of metal and can be formed into a sheet or wire shape. The outer diameter of the distal end of the catheter 10 can be set to be smaller than the outer diameter of the rest of the catheter 10 (such as Figure 2 ) to form an adhesion surface at the distal end of the catheter 10 to which the balloon 32 can be adhered. After the proximal end of the balloon 32 is adhered and fixed to the adhesion surface, the balloon 32 is crimped and fixed by using a sheet-like press buckle 34 to surround the adhesion surface, or by using a filamentous press buckle 34 to wrap around the adhesion surface, so that the balloon head 30 is further fixed to the distal end of the catheter 10, greatly reducing the possibility of the balloon head 30 becoming loose.

[0058] See also Figure 1 The pipe body also includes a four-way pipe 40. Figure 4 The four-way pipe 40 is provided with a connecting pipe 41, a conducting pipe 42, an injection pipe 43, and an exhaust pipe 44. In the four-way pipe 40, the connecting pipe 41 and the conducting pipe 42 are coaxially arranged, while the injection pipe 43 and the exhaust pipe 44 are non-coaxially arranged with respect to the connecting pipe 41 and / or the conducting pipe 42. The four-way pipe 40 is connected to the proximal end of the catheter 10 via the connecting pipe 41, and is connected to the guide channel 11 via the conducting pipe 42, the injection channel 12 via the injection pipe 43, and the exhaust channel 13 via the exhaust pipe 44. Furthermore, suitable sealing structures are employed at the connection between the connecting pipe 41 and the catheter 10, and at the connection between the conducting pipe 42 and the puncture needle 20 to ensure a sealing effect and prevent leakage of the filling liquid from the connection.

[0059] See also Figure 4 The opening of the conducting tube 42 is detachably provided with a sealing end cap 45, and a sealing ring 46 may be provided between the opening of the conducting tube 42 and the sealing end cap 45. The sealing end cap 45 defines a conducting opening that communicates with the conducting tube 42. After the puncture needle 20 passes through the conducting opening, the sealing ring 46 and the sealing end cap 45 form a sealed connection at the opening of the conducting tube 42. In some embodiments, the sealing end cap 45 may be replaced with other suitable structures to achieve a sealed connection between the puncture needle 20 and the conducting tube 42. For example, an annular rim (not shown) may be provided at the edge of the opening of the conducting tube 42, extending toward the puncture needle 20 and allowing the puncture needle 20 to pass through. A sealing groove may be defined on the inner wall of the opening of the conducting tube 42, and the sealing ring 46 may be installed in the sealing groove to assist the annular rim in ensuring a sealed connection between the puncture needle 20 and the opening of the conducting tube 42.

[0060] The outlet of the exhaust pipe 44 is detachably provided with a one-way check valve 441 (e.g. Figure 10 By providing a one-way one-way valve 441 at the mouth of the exhaust pipe 44, the liquid and gas inside the fistula balloon dilatation catheter 100 can be discharged from the inside to the outside in a one-way manner, thereby preventing external air from reversely entering the internal space of the fistula balloon dilatation catheter 100 when the gas and liquid are discharged, thereby ensuring that the internal gas is completely discharged.

[0061] See also Figure 10When using the fistula balloon dilatation catheter 100, the operator connects the syringe 200 to the injection tube 43 of the four-way tube 40, and then gradually pushes the piston rod of the syringe 200 to inject the filling liquid in the syringe 200 from the injection tube 43 into the interior of the fistula balloon dilatation catheter 100. After the filling liquid enters the injection tube 43, the filling liquid flows into the expansion cavity of the balloon head 30 along the injection channel 12. As the filling liquid is continuously injected, the filling liquid will fill the entire expansion cavity, and then gradually fill the exhaust channel 13 from the distal end to the proximal end of the fistula balloon dilatation catheter 100 along the exhaust channel 13. During this process, the gas is discharged from the exhaust pipe 44. When the exhaust pipe 44 discharges the filling liquid, the valve port of the one-way one-way valve 441 is closed. Since the internal space of the fistula balloon dilatation catheter 100 is sealed, and the elastic deformation on both sides of the balloon 32 is stronger than the elastic deformation in the middle of the balloon 32, when the filling liquid fills the entire internal space of the fistula balloon dilatation catheter 100, the balloon 32 will expand into a shape with a concave middle and bulging at both ends under the filling of the continued injection of filling liquid.

[0062] See also Figure 1 In order to facilitate understanding and control of the retractable length of the puncture needle 20 in the human skull during the surgical operation and ensure that the surgical process is carried out safely and reliably, in the embodiment of the present application, the proximal end of the puncture needle 20 can be set as an indicator rod 23, and the surface of the rod body of the indicator rod 23 can be marked with a scale of a preset range. Optionally, the scale range of the indicator rod 23 can be set within -10mm to 30mm. It can be understood that those skilled in the art can also set the scale range of the indicator rod 21 to other reasonable values ​​according to actual needs.

[0063] In actual use, when the puncture needle 20 is not subjected to external force F, the 0 mark on the indicator rod 23 is aligned with the edge of the tube opening of the guide tube 42. When the distal end of the fistula balloon dilatation catheter 100 abuts an obstruction and the balloon head 30 is compressed, the 0 mark on the indicator rod 23 extends out of the tube opening. At this time, the mark on the rod body where the edge of the tube opening of the guide tube 42 is aligned reflects the length of the puncture needle 20 pressed into the guide channel 11, that is, the length of the compression of the return spring 21. When the puncture needle 20 is pushed by external force F, the puncture needle 20 extends out of the balloon channel R30, and the 0 mark on the indicator rod 23 extends into the tube opening. The mark on the rod body where the edge of the tube opening of the guide tube 42 is aligned reflects the length of the puncture needle 20 that has been extended outward. When the external force F acting on the puncture needle 20 is removed, the balloon head 30 is reset to its natural length without the external force F. Under the reset force of the reset spring 21, the puncture needle 20 returns to its initial position aligned with the edge of the tube opening of the guide tube 42 at the 0 scale. In this application, the proximal end of the puncture needle 20 is designed to be an indicator rod 23 with a certain scale range. The operator can easily understand the degree of compression of the balloon head and the extension length of the puncture needle 20 in the human brain through the scale of the indicator rod 23, ensuring that the compression of the balloon head and the extension of the puncture needle 20 are within the allowable range, thereby ensuring a safe and reliable operation.

[0064] Please continue reading Figure 1 To improve the operator's comfort when using the fistula balloon dilatation catheter 100 and to enhance the convenience and reliability of operation, a handle 24 can be provided at the proximal end of the puncture needle 20. Specifically, the proximal end of the puncture needle 20 can be pre-machined with an external thread, and the center of the handle 24 can be pre-machined with an internal thread that matches the external thread. The internal thread of the handle 24 cooperates with the external thread of the puncture needle 20 to achieve detachable assembly and fixation. It will be understood by those skilled in the art that the connection between the handle 24 and the puncture needle 20 is not limited to the connection via the above-mentioned threaded structure, and any other suitable connection method can be used to achieve reliable assembly and fixation, as long as it can ensure that there is no relative sliding between the handle 24 and the puncture needle 20 during the use of the fistula balloon dilatation catheter 100. By providing the handle 24 at the proximal end of the puncture needle 20, the operator can better apply force to the puncture needle 20, thereby more conveniently controlling the stretched length of the balloon head 30, which is conducive to better completing the surgical operation and reducing the operational risk.

[0065] To facilitate a better understanding of the implementation of the fistula balloon dilatation catheter 100, the following schematic description of the use process of the fistula balloon dilatation catheter 100 is made in combination with actual application scenarios.

[0066] like Figure 10During the specific operation of the fistula balloon dilatation catheter 100 of this embodiment, the patient takes a supine position after general anesthesia and is accurately positioned by MRI. A straight incision of about 3 cm is made at the center, 1 to 2 cm in front of the coronal suture and 2 to 3 cm to the right of the midline. The skin, subcutaneous tissue and galea aponeurotica are cut in sequence, and the skull is drilled to expand the bone window to 1 cm. The dura mater is electrocoagulated to stop bleeding, the dura mater is cross-cut, and the arachnoid membrane on the surface of the brain is electrocoagulated. Puncture is performed perpendicular to the line connecting the two external auditory canals through a brain needle. After the puncture is completed, the ventriculoscope 300 is placed in the ventriculoscope 300 display screen to observe the frontal angle of the ventricle A in real time, and the side walls of the ventricle A are checked in all directions. The ventricle A is slowly moved forward along the choroid plexus to find the interventricular foramen. The guide tube 310 of the ventriculoscope 300 passes through the interventricular foramen to reach the third ventricle B.

[0067] After reaching the third ventricle B, use the ventriculoscope 300 to check the lateral wall of the ventricle, reach the third ventricle floor membrane C in the vertical direction to find the mammillary bodies, use the fistula balloon dilatation catheter 100 to pass through the guide channel 310 of the ventriculoscope 300, and puncture the fistula through the puncture needle 20 in the weak area between the infundibulum recess and the bilateral mammillary bodies. Specifically: press the fistula balloon dilatation catheter 100 on the third ventricle floor membrane C with the pressure tube 31. When the balloon head 30 at the distal end of the fistula balloon dilatation catheter 100 is pressurized, the buffer spring 33 in the balloon head 30 is compressed. When the buffer spring 33 is further compressed, the puncture needle 20 is compressed, and the scale on the indicator rod 23 is continuously withdrawn to display the degree of compression of the return spring 21 of the puncture needle 20 in real time. The preferred safety range is not more than -5mm scale. The needle tip of the puncture needle 20 in the balloon channel R30 touches the The handle 24 of the puncture needle 20 is pushed to puncture the third ventricle floor membrane C, and the reset spring 21 is stretched until the indicator rod 23 of the puncture needle 20 is at the 5mm scale. The third ventricle floor membrane C can be observed to be punctured through the ventriculoscope 300. The handle 24 of the puncture needle 20 is released. If the third ventricle floor membrane C is not punctured, the handle 24 can be pushed to extend the needle tip of the puncture needle 20 to puncture the third ventricle floor membrane C again until the third ventricle floor membrane C is punctured to form a fistula. During this process, it is important to observe Observe the scale change of the indicator rod 23 to prevent the puncture needle 20 from extending too long and damaging the basilar artery D during the puncture process, causing intracranial hemorrhage; after the fistula is formed by puncture, the balloon head 30 of the fistula balloon dilatation catheter 100 is inserted into the fistula under the ventriculoscope 300. When the middle part of the balloon 32 of the balloon head 30 is coplanar with the third ventricular floor membrane C at the fistula, push the syringe pre-connected with the injection tube 43, so that the filling liquid in the syringe passes through the injection tube 43 and the injection channel 12 in sequence and enters the expansion cavity of the balloon head 30 At the same time, the gas in the balloon 32 is discharged through the exhaust tube 44 until the exhaust tube 44 discharges the filling liquid. At this time, the venting operation of the fistula balloon dilatation catheter 100 is completed, and the one-way one-way valve 441 on the exhaust tube 44 is closed. As the filling liquid is injected, the balloon 32 expands into a shape with both sides bulging, so that the balloon 32 can be stuck in the fistula opening, preventing the balloon 32 from accidentally falling off during the process of expanding the fistula opening. The filling liquid is continued to be injected to continuously expand the fistula opening until the diameter of the fistula opening is 6-8mm. After the fistula is completed, the filling liquid inside the fistula balloon dilatation catheter 100 is reversely aspirated using the syringe 200, and the balloon 32 is deflated. The fistula balloon dilatation catheter 100 is then removed, and then the ventriculoscope 300 is removed, the bone hole is sealed, and finally the scalp is sutured and the incision is bandaged. At this point, the operation is complete.

[0068] The beneficial effects of the fistula balloon dilatation catheter provided by the present application are: on the one hand, the balloon head of the fistula balloon dilatation catheter provided by the present application is connected to the distal end of the catheter and the puncture needle by using an elastic element, forming a soft head end of the fistula balloon dilatation catheter, which can avoid accidental injury to blood vessels and nerves during surgery and reduce surgical complications; on the other hand, by arranging an exhaust channel connecting the balloon head and the injection channel in the catheter, after the external filling liquid is injected into the balloon head through the injection channel, the gas in the balloon head is discharged through the exhaust channel, which is beneficial to reduce the operator's preoperative preparation work and effectively avoids the rupture of the fistula balloon dilatation catheter during use due to incomplete discharge of the gas in the balloon; in addition, the proximal end of the puncture needle is set as an indicator rod for judging the extension and retraction length of the puncture needle, making the extension and retraction of the puncture needle more intuitive and accurate to millimeters, making tissue puncture simpler, more intuitive and safer.

[0069] The above content is a further detailed description of the present application in conjunction with specific / preferred embodiments, and it cannot be determined that the specific implementation of the present application is limited to these descriptions. For those skilled in the art, various modifications and improvements can be made without departing from the concept of the present application, and these are all within the scope of protection of the present application.

Claims

1. A fistula balloon dilatation catheter, characterized in that: include: A tube body, the tube body comprising a conduit, the conduit being provided with a guide channel; a puncture needle, the puncture needle being elastically assembled in the guide channel and being able to extend and retract along the guide channel; a balloon head connected to the distal end of the catheter and provided with a balloon channel and an inflation cavity; The balloon head includes a pressure tube, a balloon and a buffer spring; The pressure tube is movably sleeved on the distal end of the puncture needle; the distal end of the balloon is sealed and sleeved on the pressure tube, and the proximal end of the balloon is sealed and sleeved on the distal end of the catheter, thereby forming the expansion cavity; the buffer spring can be compressed and accommodated in the expansion cavity, elastically connecting the pressure tube and the catheter; The balloon head can be elastically compressed and reset after compression. When the balloon head is not compressed, the needle tip of the puncture needle is accommodated in the balloon head. When the balloon head is compressed, the needle tip of the puncture needle can be extended out of the balloon head along the balloon channel under the push of external force. When the buffer spring is compressed to the maximum extent, the needle tip of the puncture needle is flush with the distal opening of the pressure tube or extends out by a preset length when the puncture needle is not pushed; The proximal end of the puncture needle is configured as an indicator rod marked with scale values.

2. The fistula balloon dilatation catheter according to claim 1, characterized in that: The guide tube is further provided with a liquid injection channel and an exhaust channel, and the guide channel, the liquid injection channel and the exhaust channel are independently provided; The proximal end of the puncture needle extends out of the proximal end hole of the catheter, and the distal end of the puncture needle extends out of the distal end hole of the catheter, and the proximal end hole and the distal end hole are two end holes communicating with the guide channel; The balloon head forms an expansion cavity at the distal end of the catheter, which is connected to the injection channel and the exhaust channel.

3. The fistula balloon dilatation catheter according to claim 1, characterized in that: The balloon head further comprises a press buckle, and the balloon head is crimped and fixed to the distal end of the catheter by the press buckle.

4. The fistula balloon dilatation catheter according to claim 2, characterized in that: The pipe body further comprises a four-way pipe, which comprises a connecting pipe, a conducting pipe, a liquid injection pipe and an exhaust pipe; Among them, the connecting tube and the conducting tube are coaxially arranged; the four-way tube is sleeved on the proximal end of the catheter with the connecting tube, connected to the guide channel through the conducting tube, connected to the injection channel through the injection tube, and connected to the exhaust channel through the exhaust pipe.

5. The fistula balloon dilatation catheter according to claim 4, characterized in that: The four-way tube is also provided with a sealing end cover and a sealing ring; the sealing end cover is detachably assembled on the tube mouth of the conducting tube, and the sealing ring is assembled between the tube mouth of the conducting tube and the sealing end cover to form a sealed connection between the puncture needle and the conducting tube.

6. The fistula balloon dilatation catheter according to any one of claims 1 to 5, characterized in that: The puncture needle is provided with a return spring, the distal end of the guide channel is provided with a first limiting ring, and the distal end of the puncture needle is provided with a second limiting ring; the distal end of the guide channel refers to the end of the guide channel close to the distal end hole of the catheter; The second limiting ring is distal to the first limiting ring, the reset spring is assembled at the distal end of the puncture needle and is located between the first limiting ring and the second limiting ring, with both ends connected to the first limiting ring and the second limiting ring respectively. When the puncture needle extends forward, the reset spring is stretched to generate a reset tension; Alternatively, the first limiting ring is at the distal end of the second limiting ring, the reset spring is assembled at the distal end of the puncture needle and is located between the first limiting ring and the second limiting ring, and the two ends are respectively connected to the first limiting ring and the second limiting ring. When the puncture needle extends forward, the reset spring is compressed to generate a reset elastic force.

7. The fistula balloon dilatation catheter according to any one of claims 1 to 5, characterized in that: The puncture needle is further provided with a handle, and the handle is fixed to the proximal end of the puncture needle.

8. The fistula balloon dilatation catheter according to claim 1, characterized in that: The distal end of the balloon covers the entire compression tube.

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