Body cavity regulation device

Abstract

The present invention relates to a body cavity adjustment device, comprising: a catheter, the catheter including, in order from the distal end to the proximal end, a first section and a second section, the first section having an adjustable curvature relative to the axial direction; and an expandable mechanism disposed on the first section, the expandable mechanism being configured to continuously contract and expand. Using the body cavity adjustment device of the present invention, the expandable mechanism can be hooked and fixed to the body cavity, and released from the body cavity, simply by adjusting the curvature of the first section. The device has a simple structure and is easy to operate, reducing surgical difficulty and minimizing intraoperative risks associated with complex surgical procedures.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to a body cavity regulating device. Background Art

[0002] Atherosclerosis is the most common cause of carotid artery stenosis in middle-aged and elderly patients. Patients often have other risk factors that predispose them to cardiovascular and cerebrovascular damage, such as hypertension, diabetes, hyperlipidemia, obesity, and smoking. Atherosclerosis is caused by the accumulation of lipids in the blood vessel walls. Macrophages within these walls engulf these lipids, forming lipid pools. This pools are accompanied by the formation of a fibrous cap. These lipid cores and caps form the primary components of atherosclerotic plaques in the arterial wall. Gradual enlargement of the plaques can lead to gradual narrowing of the vessel lumen, or the plaques can become unstable and rupture, exposing the lipid components within the plaques to the vessel lumen, leading to platelet aggregation, thrombus formation, and subsequent thrombus dislodgement. All of these factors can lead to cerebral ischemia.

[0003] Carotid artery stenosis caused by atherosclerosis is often located at the distal end of the common carotid artery, including the origin of the internal carotid artery, the siphon of the internal carotid artery, and the distal end of the internal carotid artery, which is divided into the anterior and middle cerebral artery segments. Patients with severe stenosis and symptomatic moderate stenosis typically require surgical treatment with carotid endarterectomy (CEA) to remove atherosclerotic plaques. During this procedure, blood flow to the common carotid artery is blocked, and the target vessel is opened to remove the plaque and thickened intima. While CEA is generally effective in removing plaque and intima, the sudden alteration in hemodynamics during carotid artery blockage often leads to complications such as cerebral hyperperfusion syndrome (CHS). Clinical manifestations of CHS include throbbing headaches in the frontal, temporal, and periorbital regions (sometimes diffuse); pain in the eye and face; nausea, vomiting, impaired consciousness, cerebral edema, and visual impairment; seizures; functional neurological impairment; and intracranial or subarachnoid hemorrhage. CHS can have serious and even life-threatening consequences if not properly diagnosed and treated. It is generally believed that the sudden opening of blood vessels after carotid artery surgery causes some patients with insufficient cerebral vascular autoregulation to develop hyperperfusion-related complications such as CHS.

[0004] Similar complications also occur in the surgical field of portal hypertension in cirrhosis. The incidence of portal vein thrombosis is high after splenectomy and devascularization. This is due to slow portal vein blood flow, which increases intrahepatic sinusoidal pressure. Thrombosis further worsens liver perfusion in patients with portal hypertension, impairing liver function and causing gastrointestinal congestion and portal hypertensive gastropathy. In some patients, elevated portal vein pressure remains unrelieved, leading to recurrent upper gastrointestinal bleeding. To reduce portal vein pressure and prevent gastrointestinal bleeding, intraoperative flow restriction of the splenic artery is often necessary. Currently, silk thread wrapping is commonly used, but this procedure is complex and can cause significant vascular irritation. Furthermore, flow restriction control is unstable, often resulting in splenic artery occlusion. Summary of the Invention

[0005] In order to solve the adverse reactions caused by sudden pressure changes in the body cavity after being squeezed or compressed, the present application provides a body cavity adjustment device, including:

[0006] A catheter, the catheter including a first section and a second section in order from the distal end to the proximal end along the axial direction, wherein the curvature of the first section relative to the axial direction is adjustable; and

[0007] The expandable mechanism is arranged on the first section, and the expandable mechanism is configured to be continuously contractible and continuously expandable.

[0008] Preferably, the first section is an elastic bending section.

[0009] Preferably, the first section is bent into an arc section relative to the axial direction.

[0010] Preferably, the first section spirally wraps around the axial direction at least once.

[0011] Preferably, the catheter further comprises a third section connecting the first section and the second section; the hardness of the first section and the hardness of the second section are both greater than the hardness of the third section.

[0012] Preferably, the hardness of the first section is greater than the hardness of the second section.

[0013] Preferably, a first lumen connecting the first section and the second section is provided in the catheter; the body cavity regulating device further comprises a bending adjustment wire, which is passed through the first lumen, and the distal end of the bending adjustment wire is fixed near the distal end of the first section, and the proximal end of the bending adjustment wire passes through the first lumen.

[0014] Preferably, the expandable mechanism is fixedly mounted on the first section; and / or

[0015] The catheter is provided with a second lumen communicating with the first section and the second section. The first section is provided with at least one slot communicating with the second lumen. The expandable mechanism is provided in the second lumen and is configured to expand through the slot.

[0016] Preferably, the expandable mechanism comprises at least one balloon.

[0017] Preferably, the expandable mechanism is fixedly mounted on the first section, and the expandable mechanism comprises an expandable braided mesh or an expandable cutting mesh.

[0018] The above technical solution provided by the embodiment of the present application has the following advantages compared with the prior art:

[0019] When using the body cavity adjustment device of the present invention, it is only necessary to adjust the curvature of the first section to hook and fix the expandable mechanism and the body cavity, and to release the fixation of the expandable mechanism and the body cavity. The device has a simple structure and is easy to operate, which reduces the difficulty of the operation and avoids the intraoperative risks caused by complicated surgical operations as much as possible. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0022] In the attached figure:

[0023] Figure 1 is a schematic structural diagram of a body cavity regulating device according to a first embodiment of the present invention;

[0024] Figure 2 yes Figure 1 A schematic diagram of the structure of the body cavity adjustment device after being bent and sleeved into the body cavity;

[0025] Figure 3 yes Figure 1 A schematic diagram of the body cavity regulating device in FIG. 1 when the expandable mechanism is not expanded;

[0026] Figure 4 yes Figure 1 A schematic diagram of the body cavity regulating device in the embodiment of the present invention when the expandable mechanism thereof expands and compresses the body cavity;

[0027] Figures 5A-5C yes Figure 1 A schematic diagram of the gradual expansion of the expandable mechanism of the body cavity regulating device;

[0028] Figure 6 is a schematic structural diagram of a body cavity regulating device according to a second embodiment of the present invention;

[0029] Figure 7is a schematic structural diagram of a body cavity regulating device according to a third embodiment of the present invention;

[0030] Figure 8 yes Figure 7 A schematic diagram of the structure of the body cavity adjustment device after being bent and sleeved into the body cavity;

[0031] Figure 9 yes Figure 7 A schematic diagram of the body cavity regulating device in the embodiment of the present invention when the expandable mechanism thereof expands and compresses the body cavity;

[0032] Figure 10 is a schematic structural diagram of a body cavity regulating device according to a fourth embodiment of the present invention;

[0033] Figure 11 yes Figure 10 A cross-sectional view of the body cavity adjustment device after bending;

[0034] Figure 12 is a schematic structural diagram of a body cavity regulating device according to a fifth embodiment of the present invention;

[0035] Figure 13 is a schematic structural diagram of an expandable mechanism according to a fifth embodiment of the present invention;

[0036] Figure 14 yes Figure 12 and Figure 13 Schematic diagram of the structure of the body cavity regulating device after filling and expansion. DETAILED DESCRIPTION

[0037] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the specific embodiments of the present invention are now described in detail with reference to the accompanying drawings. In the following description, it should be understood that the directions or positional relationships indicated by "front", "back", "up", "down", "left", "right", "longitudinal", "horizontal", "vertical", "horizontal", "top", "bottom", "inside", "outside", "head", "tail", etc. are based on the directions or positional relationships shown in the accompanying drawings and are constructed and operated in specific directions. They are only for the convenience of describing the technical solution and do not indicate that the devices or components referred to must have specific directions. Therefore, they should not be understood as limiting the present invention.

[0038] It should also be noted that, unless otherwise clearly specified and limited, terms such as "installed", "connected", "connected", "fixed", and "set" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intervening elements. The terms "first", "second", "third", etc. are only for the convenience of describing the present technical solution, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first", "second", "third", etc. may explicitly or implicitly include one or more of such features. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0039] In the following description, specific details such as particular system structures and techniques are provided for purposes of illustration, not limitation, to facilitate a thorough understanding of the embodiments of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail.

[0040] In describing the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; and the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device. The above definitions are for convenience only and are not to be construed as limitations of the present invention.

[0041] See Figure 1-5C According to a first embodiment of the present invention, a body cavity regulating device 1 comprises a catheter 11 and an expandable mechanism 12. The catheter 11 comprises a first section 111 and a second section 112, sequentially from the distal end to the proximal end along the axial direction H. The curvature of the first section 111 relative to the axial direction H is adjustable. The expandable mechanism 12 is disposed on the first section 111 and is configured to continuously contract and expand.

[0042] During open surgery, at the target body cavity 2, such as a target blood vessel, the curvature of the first section 111 is adjusted so that it can hook onto the body cavity 2 from the outside. This allows the expandable mechanism 12 on the catheter 11 to be fixed relative to the body cavity 2. After fixation, the expandable mechanism 12 is controlled to begin expanding. During the expansion process, the expandable mechanism 12 gradually compresses the outer wall of the body cavity 2, thereby squeezing the body cavity 2 to limit or even stop the flow of body fluids within the body cavity 2. For example, this can achieve temporary compression and hemostasis of blood vessels, or adjustable blood flow restriction during surgery. After the procedure is completed, the expansion state of the expandable mechanism 12 is adjusted again to remove its pressure on the body cavity 2, and the curvature of the first section 111 is adjusted again so that it can be withdrawn from the body cavity 2, thereby restoring the flow of body fluids within the body cavity 2. For example, this can restore blood flow after surgery, thereby protecting the end of a blood vessel, the brain, or internal organs. After surgery, the body cavity adjustment device 1 can be safely withdrawn through a smaller incision, thereby avoiding multiple injuries to the patient's incision.

[0043] In the above operation, it is only necessary to adjust the curvature of the first section 111 to hook and fix the expandable mechanism 12 and the body cavity 2, and to release the fixation of the expandable mechanism 12 and the body cavity 2. The device has a simple structure and is easy to operate, which reduces the difficulty of the operation and avoids the intraoperative risks caused by complicated surgical operations as much as possible.

[0044] Specifically, first section 111 is an elastically curved section. In its natural state, first section 111 maintains a curved state relative to axial direction H. When an external force acts, for example, when an external force is applied along direction C to bend first section 111, its elasticity allows the force to change its curvature, reducing its bending amplitude and widening the opening formed by the bending. The widened opening can then be positioned on the periphery of body cavity 2. Once the external force is removed, the section 111 elastically returns to its original curvature, thereby hooking onto body cavity 2 and securing catheter 11 therewith. After the body cavity adjustment is completed, the same operation can be performed to utilize the elasticity of first section 111 to open the curved section and remove it from body cavity 2.

[0045] In a specific implementation of this embodiment, the first section 111 is bent into an arc section relative to the axial direction H. The so-called arc section means that the first section 111 has not yet bent around the axial direction H, so there is still an opening. When the first section 111 is bent along the direction C, the opening can be further opened. After the external force is removed, it can rely on elasticity to restore to the original arc state.

[0046] The catheter 11 can be an extruded tube of a polymer material, and the polymer material can be a segmented polyetheramide resin (PEBAX), polyurethane (PU), etc. The length and diameter of the catheter 11 can be set according to the usage scenario. For example, in an exemplary application, the effective length of the catheter 11 is 110 mm and the diameter is 8F (2.7 mm). The distal end of the catheter 11 can be pre-plasticized so that the first section 111 of the distal end of the catheter 11 is pre-bent relative to the axial direction H. In this embodiment, the first section 111 is an arc section, so its curvature is less than 360°, such as 270°, 210°, etc., so that a gap opening is formed between the distal end of the first section 111 and the second section 112. Of course, this curvature is only used as an example and is not a limitation of the present invention. In other embodiments, it can also be pre-bent to other angles, such as about 360°, to form an approximately circular ring shape.

[0047] The catheter 11 can also be a multi-lumen extruded tube. During the extrusion process, multiple lumens are formed along the axial direction H. These lumens can be embedded in both the first section 111 and the second section 112, thereby connecting the first section 111 and the second section 112. The cross-section of the lumens perpendicular to the axial direction H can be circular, elliptical, oblong, rectangular, or other custom shapes. The multi-lumen configuration of the catheter 11 can be used for a variety of purposes, such as a guidewire lumen for the passage of a guidewire, a lumen for fluid flushing or blood aspiration, etc.

[0048] Specifically, the expandable mechanism 12 is a continuously expandable and continuously contractible mechanism, which is fixedly mounted on the first section 111. In this embodiment, the expandable mechanism 12 includes a balloon 12. The balloon 12 can be gradually adjusted from an initial unfilled state to a maximum filled state, or the filled balloon 12 can be depressurized to gradually reduce its size or volume, thereby achieving continuous adjustment of the size or volume of the expandable mechanism 12 through the filling adjustment of the balloon 12. The balloon 12 can be a non-compliant balloon 12 made of nylon material, and the filled diameter of the balloon 12 is 6-12 mm, for example, 8 mm. The balloon 12 can also be a flexible long-segment balloon 12 to cover the entire first section 111, rather than unilateral squeezing. This method can further reduce stimulation to the body cavity 2. An eccentric balloon 12 can also be used to reduce the impact on surrounding tissues.

[0049] See also Figure 2The balloon 12 is sleeved on the outer peripheral wall of the first section 111. Correspondingly, the catheter 11 also includes a filling cavity 11a provided in the tube wall and a filling opening 11b opened on the tube wall. The filling cavity 11a is connected to the balloon 12 through the filling opening 11b. The filling cavity 11a along the axial direction H is one of the above-mentioned extruded tube lumens. The inner diameter of the filling cavity 11a is 0.3-0.7 mm, for example, 0.5 mm in this embodiment. The body cavity regulating device 1 also includes at least one Luer connector 13. The Luer connector 13 is connected to the catheter 11 at the proximal end of the second section 112 and is connected to the filling cavity 11a. The filling liquid can fill the balloon 12 through the Luer connector 13 and the filling cavity 11a to increase its volume or size. The filling liquid of the balloon 12 can also flow out of the filling cavity 11a and the Luer structure to relieve pressure. During the pressure relief process, the volume or size of the balloon 12 gradually decreases to adjust the expansion state.

[0050] See also Figure 3 When the first section 111 hooks the body cavity 2 and fixes it relative to the body cavity 2, the balloon 12 is initially in an unfilled state. The filling cavity 11a is connected to the balloon 12 through the filling opening 11b, and the filling liquid enters the balloon 12 through the filling catheter 11 and the filling opening 11b to fill the balloon 12. Figure 4 The filled balloon 12 gradually compresses the body cavity 2, thereby adjusting the filling size or volume of the balloon 12 through filling, so that the body fluid slows down from the abundant B1 state to the limited B2 state, thereby achieving flow limitation or blocking.

[0051] The above expandable mechanisms 12 are used as examples and are not limitations of the present invention. Ordinary technicians in this field can select a suitable expandable mechanism according to actual needs. For example, the expandable mechanism 12 can also include two balloons spaced apart along the axial direction H, and both balloons are provided on the first section 111. During operation, after the catheter 11 hooks and fixes the body cavity 2, the two balloons can be filled at the same time, and the body cavity 2 can be compressed or squeezed relative to the axial direction H. The double-balloon design can make the compressed surface of the body cavity 2 longer relative to the axial direction H, thereby alleviating the stimulation to the body cavity 2; in addition, the two balloons can be distributed on both sides of the body cavity 2 following the bent catheter 11, so that they can be squeezed from both sides at the same time. In this way, on the basis of obtaining the same squeezing effect, the size of a single balloon can be appropriately reduced, thereby improving the safety of the insertion and withdrawal of the device and reducing the impact of the large balloon on the surrounding tissues and the body cavity 2 after filling.

[0052] For another example, the expandable mechanism 12 may also include an expandable mesh, such as a woven mesh or a cut mesh. The mesh may be woven from a metal material or cut from a metal tube, such as stainless steel or nickel-titanium alloy. After the mesh is squeezed and expanded, it can compress the body cavity 2 (such as a blood vessel) through radial support force, thereby changing the flow rate and flow rate of the body fluid in the body cavity 2 by changing the cross-sectional area of ​​the body cavity 2. Other expandable mechanisms 12 are no longer listed one by one, and the body cavity regulating device 1 with various expansion mechanisms set based on the teachings of the present invention is within the scope of protection of the present invention.

[0053] See Figure 5A In the initial filling stage of the balloon 12, the balloon 12 slightly compresses the body cavity 2 (eg, the target blood vessel), and the deformation of the body cavity 2 is not obvious. Figure 5B As the filling continues, the further expanded balloon 12 gradually increases the pressure on the body cavity 2. The compressed body cavity 2 abuts against the catheter 11 under the surrounding of the curved first section 111, thereby limiting the deformation space of the body cavity 2, making the cross-sectional area of ​​the compressed body cavity 2 smaller and smaller, and the blood flow through the cross-sectional area gradually reduced. Figure 5C When the balloon 12 is fully filled, the body cavity 2 is compressed to the minimum, and the amount of body fluid flowing through is minimal. In the above operation, by gradually adjusting the filling of the balloon 12 and limiting the deformation space of the body cavity 2, the size of the body fluid can be gradually adjusted, and then the passage of the body fluid can be finally blocked. For example, when the body cavity 2 is a blood vessel, the blood flow size can be gradually adjusted. When the operation is completed or the organ protection is completed, the balloon 12 can be completely depressurized to relieve the squeezing and oppression on the body cavity 2. At the same time, when the balloon 12 expands, it abuts against the outer wall of the body cavity 2, providing a reaction force, thereby realizing the adjustment of the space of the body cavity 2 during the expansion or contraction of the expandable mechanism 12. The operation is simple and easy to implement.

[0054] The body cavity regulating device 1 of the present invention has an adjustable curvature of the first section 111, so that the first section 111 can hook the body cavity 2, so as to form a space to limit the deformation of the body cavity 2 through its bending, thereby confining the body cavity 2 within the curved space. Combined with the expandable mechanism 12, the body cavity 2 can be compressed by expansion or released by expansion and retraction, thereby realizing continuous regulation of the flow rate of body fluids in the body cavity 2 and blocking the flow of body fluids. When the body cavity 2 is a blood vessel, it can be called a target blood vessel during operation, that is, the flow of blood in the blood vessel can be regulated and the flow of blood can be blocked.

[0055] During operation, it is only necessary to inflate or depressurize the balloon 12 and to manipulate the curvature of the first section 111. It is highly safe and easy to operate. The present invention uses an expandable mechanism 12 with a larger contact area, such as a balloon 12 to compress the body cavity 2, which will not cause excessive stimulation to the local body cavity 2. For example, for blood vessels, it can reduce the risk of postoperative vascular intimal hyperplasia. The body cavity regulating device 1 of the present invention can be retained in the body for a short period of time. For example, after carotid endarterectomy, in order to reduce the risk of brain damage caused by high perfusion, the body cavity regulating device 1 can be used for temporary flow limitation after carotid artery surgery. In the process of flow limitation, the blood flow can be continuously adjusted by controlling the filling state of the balloon 12. The operation is simple and controllable. In the present invention, it is only necessary to directly operate the first section 111 to achieve and release the limitation of the body cavity 2. The operation is convenient, safe and reliable. Compared with the traditional silk thread winding method, it can still perform unlocking, blood flow regulation and reflow operations after the wound is sutured. There is no need to unlock and remove it in a visual environment, and there is no risk of entanglement and knotting. It greatly improves safety and operability, and provides more flexible and changeable postoperative treatment plans for different surgical procedures.

[0056] See Figure 6 Compared with the first embodiment, the difference of the body cavity regulating device 1 according to the second embodiment of the present invention is that the first section 111 is spirally wound at least one circle relative to the axial direction H. The first section 111 is no longer wound into a circle segment relative to the axial direction H, but is spirally wound at least one circle, which can be more than one circle but less than two circles, or multiple circles, such as two circles or three circles, etc. Of course, it can also be not an integer circle, but somewhere in between, for example, more than three circles but less than four circles. By extending the curved portion of the first section 111, that is, increasing the number of winding circles with the body cavity 2, the contact area between the catheter 11 and the body cavity 2 can be further increased, and the displacement or slippage of the blood vessel caused by the filling of the balloon 12 can be reduced. It can be understood that in other embodiments, the fixed catheter 11 can be made of other flexible polymer materials or specially cut metal tubes to achieve a special fixation effect.

[0057] See Figure 7-Figure 9Compared to the first embodiment, the body cavity adjustment device 1 according to the third embodiment of the present invention differs in that the catheter 11 further includes a third section 113 connecting the first section 111 and the second section 112. The hardness of the first section 111 and the hardness of the second section 112 are both greater than the hardness of the third section 113. For example, the first section 111 wrapped around the body cavity 2 can be made of a material with a hardness of 75D, the third section 113 connecting the first section 111 and the second section 112 can be made of a material with a hardness of 55D, and the second section 112 can be made of a material with a hardness of 65D. The length of the third section 113 is shorter than the length of the first section 111 and the second section 112. For example, when the total length of the catheter 11 is 110 mm, the third section 113 is approximately 5 mm long. By adjusting the length of the third section 113, the stability between the catheter 11 and the body cavity 2 can be further improved and the difficulty of operating the catheter 11 can be reduced.

[0058] A three-section splicing design is adopted, in which the first section 111 is made of the material with the highest hardness and is pre-plasticized to make it bendable, making the catheter 11 more stable after being wrapped around the body cavity 2, and effectively reducing vascular displacement when the balloon 12 is inflated or vascular slippage caused by deformation of the catheter 11. The design of the relatively flexible third section 113 in the middle can reduce the difficulty of sheathing and releasing the catheter 11. When the catheter 11 needs to be sheathed on the body cavity 2, only slight control of the first section 111 is required, and the flexible third section 113 assists in changing the bending section of the first section 111; and when release is required, the operator slightly pulls back along the second section 112, which can cause the third section 113 to bend under the action of tension and vascular resistance. Combined with the adjustable curvature of the second section 112, the release of the instrument from the body cavity 2 is achieved. The position of the balloon 12 in the first section 111 can also be adjusted so that when the balloon 12 expands, the balloon 12 applies radial pressure along the first section 111 to the body cavity 2, and this pressure does not cause deformation of the curved portion, thereby preventing accidental slippage of the blood vessel.

[0059] This solution further improves the stability of the catheter 11's fixation with the target vessel and reduces the difficulty of adjusting the curvature of the first segment 111. This reduces the difficulty of installing and releasing the device, reduces the risk of intraoperative device failure, and improves surgical efficiency. Of course, the hardness of the catheter 11 can also be adjusted by combining multiple segments or by adjusting the positional relationship between different regions to meet specific surgical requirements. In a preferred embodiment of this embodiment, the hardness of the first segment 111 is further greater than that of the second segment 112, to achieve better release ability or more stable anchoring.

[0060] See Figure 10 and Figure 11Compared with the first embodiment, the body cavity regulating device 1 according to the fourth embodiment of the present invention is different in that the first section 111 is an adjustable bend catheter. Specifically, the catheter 11 is provided with a first lumen 11c connecting the first section 111 and the second section 112. The body cavity regulating device 1 also includes a bend adjustment wire 15, which is passed through the first lumen 11c. The distal end of the bend adjustment wire 15 is fixed near the distal end of the first section 111, and the proximal end of the bend adjustment wire 15 passes through the first lumen 11c.

[0061] Specifically, the first lumen 11c is embedded in the walls of both the first section 111 and the second section 112. For example, the first lumen 11c extends through the entire second section 112 and within the first section 111 to near the distal end of the first section 111, thereby connecting the first section 111 with the second section 112. The body cavity regulating device 1 also includes a first connector 14, which is connected to the proximal end of the second section 112 and communicates with the first lumen 11c. The bending wire 15 passes from the first connector 14 into the first lumen 11c, extends within the first section 111 and the second section 112, and is then secured near the distal end of the second section 112.

[0062] The bending wire 15 can be a metal wire made of a nickel-titanium alloy. The distal end of the bending wire 15 is secured to the distal end of the first segment 111 by heat-melting, welding, or bonding. The bending wire 15 is movably disposed within the first lumen 11c and may contact the inner wall of the first lumen 11c, but is not secured thereto. The proximal end of the bending wire 15 extends from the first connector 14. Because the bending wire 15 is located on one side of the catheter 11, pulling on the bending wire 15 forces the first segment 111 to bend toward the side being pulled, thereby achieving adjustable curvature of the first segment 111 during operation. During use, the body cavity adjustment device 1 of this embodiment can bend the first segment 111 simply by pulling back on the bending wire 15. Once the first segment 111 has completely wrapped around the body cavity 2, the bending wire 15 is secured, securing the catheter 11 relative to the body cavity 2. After the flow limiting or stopping of the body cavity 2 is completed, the bending wire 15 is released to adjust the curvature of the first section 111 , that is, the bending opening relative to the axial direction H is increased, thereby releasing the body cavity 2 from the entanglement of the first section 111 .

[0063] It is understood that, in order to ensure that the bending of the catheter 11 occurs only in the first section 111, the hardness of the first section 111 can be set to be smaller than the hardness of the second section 112, so that when the bending wire 15 is pulled, the bending deformation of the catheter 11 is concentrated in the first section 111. It is understood that, in order to reduce the difficulty of bending adjustment, the first section 111 can be appropriately bent to pre-plasticize, thereby reducing the travel of the bending wire 15 requiring bending, and at the same time reducing the deformation stress that the catheter 11 needs to withstand during bending, thereby reducing the risk of damage.

[0064] See Figures 12 to 14 Compared with the first embodiment, the body cavity regulating device 1 according to the fifth embodiment of the present invention is different in that a second lumen 11d is provided in the catheter 11 to connect the first section 111 and the second section 112, the first section 111 is provided with at least one slot 11e to connect the second lumen 11d, and the expandable mechanism 12 is provided in the second lumen 11d and is configured to expand through the slot 11e. Figure 13 The expandable mechanism 12 includes a balloon 12a, a balloon catheter 12b connected to the balloon 12a at its proximal end, and a Luer connector 12c connected to the distal end of the balloon catheter. The balloon 12a and balloon catheter 12b are embedded in the second lumen 11d, with the Luer connector 12c extending out of the second lumen 11d.

[0065] When the first section 111 is bent to hook the body cavity and fixed relative to the body cavity, the balloon in the expandable mechanism 12 is initially in an unfilled state. At this time, the balloon catheter 12b connected to the balloon 12a is embedded in the second lumen 11d together with the balloon 12a. The balloon catheter 12b serves as a filling cavity and is connected to the Luer connector 12c. Therefore, the filling liquid input from the Luer connector 12c can be filled into the balloon 12a to fill the balloon 12a. Figure 14 At this point, balloon catheter 12a is filled with the filling fluid, and balloon catheter 12b is completely embedded in second lumen 11d. The inflated balloon 12a gradually emerges from slot 11e, compressing the body cavity. This inflated state adjusts the size or volume of balloon 12, slowing the flow of body fluid from an abundant state to a restricted state, ultimately achieving flow restriction or blockage.

[0066] The balloon is placed in the second lumen, simplifying the manufacturing process. Furthermore, when the balloon is no longer fixedly mounted on the catheter, the balloon and the catheter liner form a separate structure, allowing for flexible combination. Suitable catheters can be selected for target vessels of varying diameters for vascular fixation, minimizing vascular damage. To address varying blood occlusion needs, such as acute compression hemostasis, perioperative prophylactic occlusion, or intracranial blood pressure control, the original catheter can be replaced with a different liner balloon, such as a high-pressure or compliant balloon, enabling easy switching between different functions to meet diverse occlusion requirements. Furthermore, the catheter can be equipped with multiple slots, tailored to the target vessel's needs, to accommodate multiple balloons for multi-point compression. Even when using only a single liner balloon, the additional slots eliminate the risk of interference or increased resistance. Furthermore, balloons of the same specification can be combined with slots of varying shapes to achieve varying shapes, local sizes, and pressures, broadening the range of applications for a single balloon and avoiding the increased costs associated with stocking multiple specifications.

[0067] The above is only used as an example. Of course, two expandable mechanisms can be set at the same time, one expansion mechanism is fixedly mounted on the first section, and the other expandable mechanism is passed through the second lumen of the first section, so that the two expansion mechanisms can be used to simultaneously regulate the flow in the body cavity, ultimately achieving flow limiting or blocking.

[0068] It is understandable that the above embodiments only express the preferred implementation modes of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the patent scope of the present invention. It should be pointed out that for ordinary technicians in this field, without departing from the concept of the present invention, the above technical features can be freely combined, and several deformations and improvements can be made, all of which fall within the scope of protection of the present invention. Therefore, all equivalent changes and modifications made to the scope of the claims of the present invention should fall within the scope of coverage of the claims of the present invention.

Claims

1. A body cavity regulating device, characterized in that: include: A catheter, the catheter including a first section and a second section in sequence from a distal end to a proximal end along the axial direction, wherein the curvature of the first section relative to the axial direction is adjustable; as well as an expandable mechanism provided on the first section, the expandable mechanism being configured to be continuously contractible and continuously expandable; The conduit further includes a third section connecting the first section and the second section; The hardness of the first segment and the hardness of the second segment are both greater than the hardness of the third segment; The catheter is provided with a first lumen connecting the first section and the second section; the body cavity adjustment device further includes a bending adjustment wire, which is passed through the first lumen, and the distal end of the bending adjustment wire is fixed near the distal end of the first section, and the proximal end of the bending adjustment wire passes through the first lumen.

2. The body cavity regulating device according to claim 1, characterized in that: The first section is an elastic bending section.

3. The body cavity regulating device according to claim 2, characterized in that: The first section is bent relative to the axial direction to form an arc section.

4. The body cavity regulating device according to claim 2, characterized in that: The first section spirally wraps around the axial direction for at least one circle.

5. The body cavity regulating device according to claim 1, characterized in that: The hardness of the first section is greater than the hardness of the second section.

6. The body cavity regulating device according to any one of claims 1 to 5, characterized in that: The expandable mechanism is fixedly mounted on the first section; and / or The catheter is provided with a second lumen connecting the first section and the second section, the first section is provided with at least one slot hole connecting the second lumen, and the expandable mechanism is provided in the second lumen and configured to expand through the slot hole.

7. The body cavity regulating device according to claim 6, characterized in that: The expandable mechanism includes at least one balloon.

8. The body cavity regulating device according to any one of claims 1 to 5, characterized in that: The expandable mechanism is fixedly sleeved on the first section, and the expandable mechanism includes an expandable braided mesh body or an expandable cutting mesh body.

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