Body cavity regulating device
The body cavity regulation device addresses complications from sudden blood flow changes by using a flexible catheter with an expandable mechanism to safely manage blood flow and pressure, offering controlled and risk-reduced post-operative care.
Patent Information
- Application Number
- CN202110051410.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-01-14
- Publication Date
- 2025-07-15
- Estimated Expiration
- 2041-01-14
AI Technical Summary
Prior art In atherosclerosis surgery and portal hypertension surgery, adverse reactions caused by pressure mutations after body cavity compression or compression deformation, such as cerebral hypertension syndrome and complications of portal hypertension, are complex in operation and low in safety.
The adjustable bend catheter is used to combine the expandable mechanism and cable. By adjusting the expansion state of the expandable mechanism and cable locking, simple and safe current limiting and flow adjustment of the body cavity is achieved, avoiding the complexity and instability of traditional wire wrapping.
It is simple to operate and has high safety. It can achieve short-term in vivo indwelling, continuously adjust the flow of body fluids, and conveniently remove the limit process, reduce the risk of complications, and improve the flexibility and safety of postoperative treatment.
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Figure CN113974743B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of interventional medical devices, and particularly 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 are prone to cause cardiovascular and cerebrovascular damage, such as hypertension, diabetes, hyperlipidemia, obesity, smoking, etc. Atherosclerosis is caused by the accumulation of lipid substances on the blood vessel wall. Macrophages in the blood vessel wall phagocytize lipid substances to form lipid pools, and at the same time, a fibrous cap is formed on the surface of the lipid pool. The lipid core and the fibrous cap constitute the main components of atherosclerotic plaques in the arterial wall. The plaque gradually increases, causing the lumen to gradually narrow, or the plaque is unstable and ruptures, and the lipid components in the plaque are exposed in the blood vessel lumen, leading to platelet aggregation to form thrombus, and the thrombus detaches. The above can all lead to the occurrence of cerebral ischemia events.
[0003] Carotid artery stenosis caused by atherosclerosis is often located at the end of the common carotid artery, the origin of the internal carotid artery, the siphon part of the internal carotid artery, and the end of the internal carotid artery where it divides into the anterior cerebral artery and the middle cerebral artery. Patients with severe stenosis and symptomatic moderate stenosis usually need to undergo a surgical treatment of carotid endarterectomy (CEA) to remove atherosclerotic plaques. During the operation, the blood flow of the common carotid artery is blocked, and the target blood vessel is incised to peel off the plaque and the thickened intima. CEA surgery usually treats plaques and intima efficiently, but during the process of blocking the blood flow of the common carotid artery, the suddenly changed hemodynamics often brings related complications such as cerebral hyperperfusion syndrome (CHS). The clinical manifestations of CHS include pulsatile headache in the fronto-temporal region and around the orbit (sometimes the headache can be diffuse); pain in the eye and face; nausea, vomiting, disturbance of consciousness, cerebral edema and visual impairment; epilepsy; functional nerve damage; intracranial or subarachnoid hemorrhage, etc. Clinically, if CHS is not correctly diagnosed and treated, it can cause serious or even life-threatening consequences. It is generally believed that the sudden opening of the blood vessel after carotid artery surgery causes hyperperfusion-related complications such as CHS in some patients with insufficient cerebrovascular autoregulation function.
[0004] Similarly, in the field of surgical operations for liver cirrhosis with portal hypertension, the incidence of portal vein system thrombosis after devascularization by splenectomy is relatively high. The reason is that the portal vein blood flow is slow, that is, the pressure in the hepatic sinus increases. The formation of thrombus further deteriorates the liver perfusion of patients with portal hypertension. On the one hand, it damages the liver function, and on the other hand, it causes gastrointestinal congestion, resulting in portal hypertensive gastropathy. The elevated portal vein pressure state of some patients is not relieved, leading to recurrent upper gastrointestinal bleeding. In order to reduce the portal vein pressure and avoid gastrointestinal bleeding, it is often necessary to limit the flow of the splenic artery during the operation. Currently, the method of winding silk thread is mostly used, but the operation is complex, the stimulation to blood vessels is large, and the flow-limiting control is unstable, often resulting in situations such as splenic artery occlusion. Summary of the Invention
[0005] To solve the adverse reactions caused by the sudden change in pressure after the body cavity is deformed by extrusion or compression, the present application provides a body cavity regulating device, including:
[0006] An adjustable-bend catheter, the catheter includes an axial tube wall and an axial lumen surrounded by the tube wall;
[0007] An expandable mechanism fixedly sleeved on the catheter; and
[0008] A cable, the cable is movably threaded through the lumen, and is configured to pass through the lumen from the tube wall on one side of the expandable mechanism, so that the catheter bends relative to the expandable mechanism and then passes back through the tube wall into the lumen.
[0009] Preferably, the expandable mechanism includes at least one balloon.
[0010] Preferably, the expandable mechanism includes two axially spaced balloons.
[0011] Preferably, the expandable mechanism includes an expandable braided mesh or an expandable cut mesh.
[0012] Preferably, the cable is configured to pass through the lumen from the tube wall on one side of the expandable mechanism, so that after the catheter bends relative to the expandable mechanism, it passes back through the tube wall on the other side of the expandable mechanism into the lumen.
[0013] Preferably, the catheter includes a distal opening and a first opening formed on the tube wall on the proximal side of the expandable mechanism; both the distal opening and the first opening communicate with the lumen, and the cable passes out from the distal opening and passes into the first opening.
[0014] Preferably, the catheter includes a first opening formed on the tube wall on the proximal side of the expandable mechanism and a second opening formed on the tube wall on the distal side of the expandable mechanism; both the first opening and the second opening communicate with the lumen, and the cable passes out from the first opening and passes into the second opening.
[0015] Preferably, the catheter further includes a third opening disposed near the first opening; the third opening communicates with the lumen.
[0016] Preferably, the cable is configured to pass through the lumen from the tube wall on one side of the expandable mechanism, bypass the catheter on the other side of the expandable mechanism, and then pass back into the lumen through the tube wall at the place where the cable passes out of the lumen.
[0017] Preferably, the catheter sequentially includes a first section and a second section along the axial direction from the distal end to the proximal end. The hardness of the first section is less than that of the second section, and the expandable mechanism is fixedly sleeved on the first section.
[0018] The above technical solutions provided by the embodiments of the present application have the following advantages compared with the prior art:
[0019] When using the body cavity adjusting device of the present invention, during the operation, it is only necessary to change the expansion state of the expandable mechanism and lock the adjustable bending catheter through the cable. The operation is simple and the safety is high. An expandable mechanism with a larger contact area is adopted, which will not cause excessive irritation to the local body cavity. The body cavity adjusting device of the present invention can also be indwelled in the body for a short term. During the process of restricting the flow, the flow rate of the body fluid in the body cavity can continue to be adjusted by adjusting the expandable mechanism, and the operation is simple and controllable. And only by controlling the cable can the limit on the body cavity be released. This release process is convenient, safe and reliable. Compared with the traditional silk winding method, it can still perform unlocking, blood flow regulation and reperfusion operations after the wound is sutured, without the need to unlock and remove under a visible environment, and there is no risk of winding and knotting, which greatly improves the safety and operability and provides a more flexible postoperative treatment plan for different surgical methods. Description of the Drawings
[0020] The drawings here are incorporated into the specification and form a part of this specification, showing the embodiments consistent with the present invention, and are used together with the specification to explain the principles of the present invention.
[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, without creative efforts, other drawings can also be obtained according to these drawings.
[0022] In the drawings:
[0023] Figure 1 is a schematic structural diagram of the body cavity adjusting device according to the first embodiment of the present invention;
[0024] Figure 2 is Figure 1 the schematic structural diagram of the body cavity adjusting device in after being bent;
[0025] Figure 3 isFigure 1 Schematic diagram of the expandable mechanism of the coelom regulating device in
[0026] Figure 4 is Figure 3 Enlarged view of area C1 in
[0027] Figure 5 is Figure 1 Cross-sectional view of the coelom regulating device in
[0028] Figure 6 is Figure 1 Schematic diagram of the coelom being compressed by the expanded expandable mechanism of the coelom regulating device in
[0029] Figures 7A - 7C is Figure 1 Schematic diagram of the gradual expansion of the expandable mechanism of the coelom regulating device in
[0030] Figure 8 Structural schematic diagram of the coelom regulating device according to the second embodiment of the present invention;
[0031] Figure 9 is Figure 8 Partial cross-sectional view of the coelom regulating device in the bending adjustment part;
[0032] Figure 10 Structural schematic diagram of the coelom regulating device according to the third embodiment of the present invention;
[0033] Figure 11 Structural schematic diagram of the coelom regulating device according to the fourth embodiment of the present invention;
[0034] Figure 12 Structural schematic diagram of the coelom regulating device according to the fifth embodiment of the present invention;
[0035] Figure 13 Partial cross-sectional view of the coelom regulating device according to the sixth embodiment of the present invention after being received in the adjustment cavity;
[0036] Figure 14 is Figure 13 Partial cross-sectional view of the coelom regulating device after expanding and protruding from the adjustment cavity. Detailed implementation manners
[0037] For a clearer understanding of the technical features, objectives, and effects of the present invention, the specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, it should be understood that the orientation or positional relationships indicated by terms such as "front", "rear", "upper", "lower", "left", "right", "longitudinal", "transverse", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are based on the orientation or positional relationships shown in the drawings and are constructed and operated in a specific orientation, and are only for the convenience of describing the present technical solution, rather than indicating that the indicated device or element must have a specific orientation, and thus should not be construed as a limitation to the present invention.
[0038] It should also be noted that, unless otherwise clearly specified and defined, terms such as "installed", "connected", "joined", "fixed", "set" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; 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 communication inside 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 above the other element, or there may also be one or more intermediate elements. Terms such as "first", "second", "third", etc. are only for the convenience of describing the present technical solution, and should not be construed as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, features defined with "first", "second", "third", etc. can 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 specific circumstances.
[0039] In the following description, for the purpose of illustration rather than limitation, specific details such as specific system structures and technologies are proposed to thoroughly understand the embodiments of the present invention. However, those skilled in the art should clearly understand that the present invention can also be implemented in other embodiments without these specific details. In other cases, the detailed descriptions of well-known systems, devices, circuits, and methods are omitted to avoid unnecessary details from interfering with the description of the present invention.
[0040] In the description of 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, and the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device. The above definitions are only for the convenience of expression and should not be construed as a limitation to the present invention.
[0041] Refer to Figures 1 - 7C, the body cavity adjusting device 1 according to the first embodiment of the present invention includes: an adjustable bending catheter 11, the catheter 11 includes a tube wall 111 along the axis H and an axial lumen 1121 surrounded by the tube wall 111; an expandable mechanism 12 fixedly sleeved on the catheter 11; and a cable 13, the cable 13 is movably disposed in the lumen 1121 and is configured to pass through the tube wall 111 on one side of the expandable mechanism 12 out of the lumen 1121, so that after the catheter 11 is bent relative to the expandable mechanism 12, it passes back through the tube wall 111 into the lumen 1121.
[0042] Specifically, the adjustable bending catheter 11 means that the catheter 11 can be adjusted to bend relative to the axis H, and the entire catheter 11 can be adjusted to bend along the axis H, or only some segments can be adjusted to bend. For example, in a specific implementation manner of this embodiment, the catheter 11 sequentially includes a first segment 11D and a second segment 11P from the distal end to the proximal end along the axis H. The expandable mechanism 12 is fixedly sleeved on the first segment 11D. The first segment 11D can be adjusted to bend relative to the axis H, and the second segment 11P remains unchanged along the axis H and cannot be adjusted to bend. The expandable mechanism 12 can change its spatial position following the bending of the first segment 11D. There are various ways of bending, and any suitable existing method can be used for bending, such as embedding a bending wire in the tube wall 111 to pull the catheter 11 to bend, or directly bending the catheter 11 depending on the material properties of the catheter 11, which will not be elaborated here.
[0043] Furthermore, the hardness of the first segment 11D can be set to be less than the hardness of the second segment 11P to facilitate the bending of the first segment 11D. For example, the catheter 11 can be spliced by the first segment 11D and the second segment 11P. The first segment 11D uses a material with a hardness of 55D, and the second segment 11P uses a material with a hardness of 65D. At the same time, the first segment 11D adopts a pre-plasticity process, so that the first segment 11D forms a nearly closed ring in the natural state.
[0044] In this embodiment, the cable 13 is configured to pass through the tube wall 111 on one side of the expandable mechanism 12 out of the lumen 1121, so that after the catheter 11 is bent relative to the expandable mechanism 12, it passes back through the tube wall 111 on the other side of the expandable mechanism 12 into the lumen 1121.
[0045] Specifically, the lumen 1121 has openings at both the proximal end face and the distal end face of the catheter 11, that is, the lumen 1121 penetrates axially along the axis H. The cable 13 can penetrate through the opening at the proximal end face (simply referred to as the proximal opening, not labeled in the figure), pass through the lumen 1121, and then pass out through the opening at the distal end face (abbreviated as the distal opening 11a). A first opening 11b is provided on the tube wall 111 enclosing the lumen 1121. The first opening 11b is located on the proximal side of the expandable mechanism 12, so that the distal opening 11a and the first opening 11b are respectively located on opposite sides of the expandable mechanism 12. Both the distal opening 11a and the first opening 11b communicate with the lumen 1121. The cable 13 can pass out through the distal opening 11a and then pass back into the lumen 1121 through the first opening 11b.
[0046] The catheter 11 can be a multi-lumen extruded tube made of a highly flexible elastic material. This elastic material can be polyurethane. During the extrusion molding process, multiple lumens along the axis H can be formed. One of the lumens 1121 can be used for threading the cable 13. The cross-section of the lumen perpendicular to the axis can be circular, oval, oblong, rectangular, or other special shapes. The multi-lumen setting of the catheter 11 can achieve multiple functions, such as a guide wire lumen for the passage of a guide wire, a lumen for liquid flushing or blood aspiration, etc.
[0047] In a specific embodiment, the effective axial length of the catheter 11 is 100 mm, the diameter is 8F (2.7 mm), the inner diameter of the lumen 1121 is 2 mm, the axial distance between the first opening 11b and the distal opening 11a is about 28 mm, and the expandable mechanism 12 is provided 20 mm away from the distal opening 11a. It should be noted that the structure of the lumen 1121 here is only used as an example and does not limit the present invention. Those of ordinary skill in the art can select other catheters 11 with suitable sizes according to needs.
[0048] The expandable mechanism 12 is specifically a continuously expandable and continuously contractible mechanism. In this embodiment, the expandable mechanism 12 includes a balloon 12, for example, a non-compliant balloon 12 made of nylon material. The inflated diameter of the balloon 12 is 6 - 12 mm, for example, it can be 8 mm. The balloon 12 can be a flexible long-section balloon 12 to cover the entire adjustable first section 11D, rather than unilateral extrusion. This method can further reduce the irritation to the body cavity 2. An eccentric balloon can also be used to reduce the impact on surrounding tissues.
[0049] The balloon 12 is disposed between the distal opening 11a and the first opening 11b, and is sleeved on the outer peripheral wall 111 of the catheter 11. Correspondingly, the catheter 11 further includes a filling cavity 1122 disposed within the tube wall 111 and a filling opening 11c opened on the tube wall 111. The filling cavity 1122 along the axial direction H is one of the above-mentioned extruded tube cavities, and the inner diameter of the filling cavity 1122 is 0.3 - 0.7 mm. For example, 0.5 mm is taken in this embodiment. The filling cavity 1122 communicates with the balloon 12 through the filling opening 11c, and the filling liquid enters the balloon 12 via the filling catheter 11 and the filling opening 11c to fill the balloon 12, so as to adjust the filling size or volume of the balloon 12 by filling or deflating. For example, the balloon 12 can be gradually adjusted from the initial unfilled state to the maximum filled state, or the filled balloon 12 can be deflated to gradually reduce its size or volume, so as to realize the continuously adjustable size or volume of the expandable mechanism 12 through the filling adjustment of the balloon 12.
[0050] The above expandable mechanisms 12 are all used as examples and are not limitations to the present invention. Those of ordinary skill in the art can select suitable expandable mechanisms according to actual needs, which will not be elaborated here. The body cavity adjusting device 1 with each expandable mechanism provided based on the teachings of the present invention is within the protection scope of the present invention.
[0051] The cable 13 is threaded through the lumen 1121 of the catheter 11, specifically entering from the first joint 141 of the catheter 11 into the proximal opening (not marked in the figure), passing through the lumen 1121 and then exiting from the distal opening 11a; when the first section 11D of the catheter 11 is bent, the cable 13 exiting from the distal opening 11a can pass back into the lumen 1121 through the first opening 11b opened on the peripheral wall of the catheter 11 and finally exit from the first joint 141, so that the distal part of the catheter 11 is closed to form an approximate ring, so as to lock the bent state of the catheter 11 by controlling the cable 13.
[0052] The cable 13 can be a cable made of a polymer material or a multi-strand stainless steel wire rope; it can also be spliced by different materials, such as welded by a multi-strand stainless steel wire rope and a stainless steel rod, so as to improve the pushing performance of the cable 13 and improve the operation feel. To improve the operation feel of the cable 13 and reduce the risk of knotting, the cable 13 can be surface lubricated with a hydrophilic coating to reduce the friction force, and the effect of reducing the friction force can be achieved by sleeving a polymer (such as polytetrafluoroethylene) lubricating tube in a surface coating manner. The cross-section of the locking cable 13 along the near-far direction central axis can be circular, elliptical, oblong, rectangular or other special shapes.
[0053] The body cavity regulating device 1 further includes a connector assembly 14, and the connector assembly 14 includes at least one first connector 141 and at least one Luer connector 142. The first connector 141 communicates with the catheter 11 through the proximal opening of the catheter 11, so as to communicate with the lumen 1121 accommodating the cable 13. One end of the cable 13 is always outside the first connector 141, and the other end first penetrates into the first connector 141, travels through the lumen 1121 successively along directions B2 and B3, passes out from the distal opening 11a and then passes back into the lumen 1121 through the first opening 11b, and finally passes out of the first connector 141. By operating the two ends of the cable 13 near the first connector 141, the bending state of the deflectable catheter 11 can be locked and closed, or the deflectable catheter 11 can be unlocked and released, or the bending state of the catheter 11 can be controlled. The Luer connector 142 is connected to the catheter 11 at the proximal end of the catheter 11 and communicates with the inflation cavity 1122. The inflation liquid can inflate the balloon 12 through the Luer connector 142 and the inflation cavity 1122, so that its volume or size increases. The inflation liquid of the balloon 12 can also flow out from the inflation cavity 1122 and the Luer structure to relieve pressure. During the pressure relief process, the volume or size of the balloon 12 gradually decreases, and the expansion state is adjusted.
[0054] Refer to Figures 3 - 5 , during the operation, first bend the distal end of the catheter 11 around once outside the body cavity 2 (such as the target blood vessel, and B1 is the direction of body fluid or blood flow), align the distal opening 11a of the catheter 11 with the first opening 11b opened on the catheter 11, and at the same time insert one end of the cable 13 into the first connector 141, pass through the entire lumen 1121 of the catheter 11 and extend out from the distal opening 11a of the catheter 11, then pass back into the lumen 1121 through the first opening 11b opened on the outer peripheral wall of the catheter 11, and continue to return to the first connector 141, so as to fix the body cavity regulating device 1 on the body cavity 2. After the cable 13 is fixed, for example, the cable 13 can be fixed manually or by a device. The catheter 11 is in direct contact with the body cavity arm, or the gap between the catheter 11 and the body cavity wall is small.
[0055] As Figure 6 shown, after fixation, the balloon 12 is inflated through the Luer connector 142 and the catheter 11. During the inflation process, the volume of the balloon 12 gradually increases, and the enlarged balloon 12 will gradually compress the body cavity 2 (such as the target blood vessel) outside to different degrees. Refer to Figure 7A , in the initial inflation stage of the balloon 12, the balloon 12 slightly compresses the target blood vessel 2, and the deformation of the target blood vessel 2 is not obvious. Refer to Figure 7B , as the inflation continues, the further expanded balloon 12 gradually increases the compression on the body cavity 2. The body cavity 2 under compression abuts against the catheter 11 under the circumvention of the deflectable catheter 11, thereby restricting the deformation space of the body cavity 2, making the cross-sectional area of the body cavity 2 under compression smaller and smaller, and the blood flow passing through the cross-section also gradually decreases. Refer to Figure 7C, when the balloon 12 is fully inflated, the target blood vessel 2 is compressed to the limit to the minimum, and the least amount of body fluid flows through. In the above operation, by gradually adjusting the inflation of the balloon 12 and restricting 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 blocked ultimately. For example, when the body cavity 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 deflated to relieve the extrusion and compression on the body cavity 2; at the same time, the cable 13 used for locking is withdrawn to release the deformation space of the body cavity 2, so that the cavity of the body cavity 2 gradually returns to normal, and thus the instrument can be slowly withdrawn from a smaller incision.
[0056] The body cavity adjusting device 1 of the present invention forms a space for limiting the deformation of the body cavity by the cooperation of the adjustable catheter 11 and the locking cable 13, and combines the expandable mechanism 12 to expand and compress the body cavity or expand and retract to relieve the compression, so as to continuously adjust the flow rate of the body fluid in the body cavity and block the flow of the body fluid. When the body cavity is a blood vessel, it can be called a target blood vessel during the operation, that is, the blood flow in the blood vessel can be adjusted and the blood flow can be blocked.
[0057] During the operation, it is only necessary to inflate or deflate the balloon 12 and lock the adjustable catheter 11 through the cable 13, and the safety is high. The present invention uses an expandable mechanism 12 with a larger contact area, such as the balloon 12, to compress the body cavity, and will not cause excessive stimulation to the local body cavity. For example, for blood vessels, the risk of postoperative intimal hyperplasia can be reduced. The body cavity adjusting device 1 of the present invention can be indwelled in the body for a short term. For example, after carotid endarterectomy, in order to reduce the risk of brain damage caused by hyperperfusion, the present body cavity adjusting device 1 can be used for temporary blood flow restriction after carotid artery surgery. During the blood flow restriction process, the continuous adjustment of the blood flow rate can be achieved by controlling the inflation state of the balloon 12, and the operation is simple and controllable. In the present invention, only by withdrawing the cable 13 can the limit on the body cavity be released. This release process is convenient, safe and reliable. Compared with the traditional silk winding method, it can still perform unlocking, blood flow adjustment and reperfusion operations after the wound is sutured, without the need to unlock and remove under a visible environment, and there is no risk of winding and knotting, which greatly improves the safety and operability and provides a more flexible postoperative treatment plan for different surgical methods.
[0058] Refer to Figure 8 and 9, compared with the first embodiment, the difference of the body cavity adjusting device 1 according to the second embodiment of the present invention lies in that the catheter 11 includes a first opening 11b formed in the tube wall 111 on the proximal side of the expandable mechanism 12 and a second opening 11d formed in the tube wall 111 on the distal side of the expandable mechanism 12; both the first opening 11b and the second opening 11d communicate with the lumen 1121, and the cable 13 passes out from the first opening 11b and passes into the second opening 11d. The cable 13 entering from the second opening 11d can pass through the lumen 1121 and finally extend out through the distal opening 11a.
[0059] In this embodiment, the cable 13 does not need to extend out from the distal opening 11a along the bent catheter 11. Therefore, the distal end of the catheter 11 can be pre-bent, for example, pre-bent by pre-plasticity, so that the catheter 11 is more convenient for the operator to operate when fixing blood vessels or other body cavities 2, and the body cavity 2 can be limited without using additional actions to bend it. The pre-bent setting can reduce the hardness of the distal end of the catheter 11, thereby optimizing the fitting relationship between the catheter 11 and the body cavity 2. At the same time, it can be more easily withdrawn from the target body cavity 2 position after detachment, reducing the irritation to the body cavity 2, while the higher hardness at the proximal end is more convenient for the doctor to hold and operate. The alignment opening design between the first opening 11b and the second opening 11d enables a single catheter 11 to be used for patients with different blood vessel 2 diameters. Only by adjusting the complete arc of the catheter 11, the applicable range can be expanded without preparing multiple specifications for the complex and diverse patient population, reducing the stocking pressure for hospitals and enterprises.
[0060] Refer to Figure 10 , compared with the first embodiment, the difference of the body cavity adjusting device 1 according to the third embodiment of the present invention lies in that the catheter 11 further includes a third opening 11e provided near the first opening 11b, and the third opening 11e communicates with the lumen 1121. In this embodiment, the cable 13 extending out from the distal opening 11a can pass back into the lumen 1121 through the first opening 11b or can pass back into the lumen 1121 through the third opening 11e. By using different openings to pass back, the size of the bending limitation area of the catheter 11 can be changed. Thus, for patients with different body cavity diameters, only the opening used by the cable 13 needs to be adjusted. For the complex and diverse patient population, the applicable range can be expanded without preparing multiple specifications, reducing the stocking pressure for hospitals and enterprises.
[0061] Refer to Figure 11, compared with the third embodiment, the coelom regulating device 1 according to the fourth embodiment of the present invention is different in that the expandable mechanism 12 includes two balloons 121 and 122 spaced apart along the axial direction H, and both of these two balloons 121 and 122 are disposed between the distal opening 11a and the first opening 11b. During operation, when the catheter 11 is bent, the two balloons are simultaneously filled and press or squeeze the coelom along the axial direction H together. The design of the double balloons can make the compressed surface of the coelom have a greater length along the axial direction H, alleviating the irritation to the coelom; in addition, the two balloons can be distributed on both sides of the coelom following the bent catheter 11, so that squeezing can be performed simultaneously from both sides. On the basis of obtaining the same squeezing effect, the size of a single balloon can be appropriately reduced, improving the safety of inserting and withdrawing this device and reducing the influence on the surrounding tissues and coelom after the large balloon is filled.
[0062] Refer to Figure 12 , compared with the first embodiment, the coelom regulating device 1 according to the fifth embodiment of the present invention is different in that the cable 13 is configured to pass through the lumen and out of the tube wall on one side of the expandable mechanism 12, bypass the catheter 11 on the other side of the expandable mechanism 12, and then penetrate back into the lumen through the tube wall at the place where the cable 13 initially penetrates the lumen. In a specific implementation, after the cable 13 extends out of the distal opening 11a along the bent catheter 11, it bypasses the catheter 11 on the other side of the distal opening 11a relative to the balloon 12, pulls the catheter 11, and then still extends out of the distal opening 11a. Both ends of the cable 13 extend out of the first joint 141, and the bent state of the catheter 11 can be fixed by fixing these two ends, so as to realize the flow limiting or flow interruption of the coelom by expanding the balloon 12.
[0063] Refer to Figure 13 and 14, compared with the first embodiment, the difference of the coelom regulating device 1 according to the sixth embodiment of the present invention is that the expandable mechanism includes an expandable mesh body, such as a woven mesh body or an expandable cut mesh body. In a specific embodiment, the expandable mechanism 12 includes an expandable woven mesh mechanism 12a and a push rod 12b. The mesh mechanism 12a includes a woven mesh body 12a1 woven by shape memory wires, a head 12a2 that binds the woven wires at the distal end, and a steel sleeve 12a3 that binds the woven wires at the proximal end. The steel sleeve 12a3 is connected to the distal end of the push rod 12b, and the other end of the push rod 12b can extend out of the body for driving control. The catheter 11 includes an axial lumen 1121 and an adjustment lumen 1123. An opening 11f communicating with the adjustment lumen 1123 is provided on the wall of the catheter 11. The lumen 1121 is the same as that in the foregoing embodiment and is used to accommodate a cable (not shown). The mesh body 12a1 is made of a metal material, such as stainless steel or nitinol. When the push rod 12 is driven to move distally, the head 12a2 abuts against the tube wall, thereby squeezing and expanding the mesh body 12a1. After the expanded mesh body 12a1 extends out of the opening 11f, it can compress the coelom (such as a blood vessel) through the radial supporting force, so as to change the flow rate and velocity of the body fluid in the coelom by changing the cross-sectional area of the coelom. After completion, pull the push rod 12b proximally to drive the mesh body 12a1 to retract and withdraw from the opening 11f into the adjustment lumen 1123.
[0064] It can be understood that the above embodiments only represent the preferred embodiments of the present invention, and the description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent of the present invention; it should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, the above technical features can be freely combined, and several deformations and improvements can also be made, which all belong to the protection scope of the present invention; therefore, all equivalent transformations and modifications made to the scope of the claims of the present invention shall fall within the scope covered by the claims of the present invention.
Claims
1. A body cavity regulating device, characterized in that, Comprising: An adjustable bending catheter, the catheter comprising an axial tube wall and an axial lumen surrounded by the tube wall; An expandable mechanism fixedly sleeved on the catheter; And A cable, the cable movably passing through the lumen, the cable configured to pass out of the lumen through the tube wall on one side of the expandable mechanism, such that after the catheter is bent relative to the expandable mechanism, it then passes back into the lumen through the tube wall on the other side of the expandable mechanism; The catheter includes a first opening formed in the tube wall on the proximal side of the expandable mechanism and a second opening formed in the tube wall on the distal side of the expandable mechanism; both the first opening and the second opening communicate with the lumen, and the cable passes out through the first opening and passes into through the second opening; The catheter sequentially includes a first section and a second section along the axis from the distal end to the proximal end, the hardness of the first section is less than the hardness of the second section, and the expandable mechanism is fixedly sleeved on the first section.
2. The coelom regulating device according to claim 1, wherein The expandable mechanism includes at least one balloon.
3. The coelom regulating device according to claim 2, wherein The expandable mechanism includes two axially spaced balloons.
4. The coelom regulating device according to claim 1, wherein, The expandable mechanism includes an expandable braided mesh or an expandable cut mesh.
Citation Information
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