Tissue isolation device for self-circulation filling and discharging during radiotherapy

Abstract

The application discloses a tissue isolation device for self-circulation filling and discharging during radiotherapy, which is implanted into a patient and comprises: an isolation balloon arranged between a tissue of the patient receiving radiotherapy and normal tissue needing protection; a catheter with one end fixedly connected with the isolation balloon; a liquid supply mechanism fixedly connected with the other end of the catheter and used for forming an internal circulation liquid flow path with the isolation balloon; wherein the liquid supply mechanism comprises: a liquid storage bag internally containing liquid and fixedly connected with the other end of the catheter; and a liquid flow realization component arranged on the catheter and used for realizing liquid flow between the liquid storage bag and the isolation balloon or between the isolation balloon and the liquid storage bag. The tissue isolation device is completely implanted into the patient and will not fall off or displace during use, can realize filling and emptying of the isolation balloon by means of self-circulation of internal liquid, is convenient and safe to operate, avoids repeatedly puncturing the skin during radiotherapy operation, reduces the risk of infection, and relieves the patient's pain.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a self-circulating tissue isolation device implanted in the body during radiotherapy for intra-abdominal tissue isolation. Background Technology

[0002] In intraperitoneal radiotherapy for tumors, if the tissue to be irradiated is close to other vital organs (such as the intestines), the radiation can easily damage surrounding organs simultaneously during the irradiation of the tumor lesion. This is especially true for normal tissues and other radiation-sensitive organs, which may develop complications such as ulceration and perforation after irradiation, seriously jeopardizing the patient's treatment safety. Therefore, how to effectively protect surrounding sensitive organs during radiotherapy is one of the urgent problems to be solved.

[0003] Currently, to reduce damage to normal organs during radiotherapy, balloon isolation technology is being used clinically. This involves placing a fluid-filled balloon between the radiotreated tissue and surrounding normal organs to provide a physical barrier. However, in some confined spaces or areas with tightly packed tissue structures (such as the retroperitoneum), prolonged and continuous pressure from the implanted balloon can cause pressure damage to the tissue, potentially leading to tissue necrosis in severe cases. Since daily radiotherapy sessions only last 10-20 minutes, pressure damage can be avoided by intermittently inflating and deflating the balloon. This means inflating the balloon only during radiotherapy each day and deflating it afterward to relieve tissue pressure.

[0004] For example, Chinese Patent No. CN116440428B discloses an implantable tissue isolation device that can be repeatedly inflated and deflated in the body. Its isolation balloon is implanted and can be repeatedly inflated and deflated. However, the inflation and deflation of this balloon still requires an external inflation device, such as a syringe with a non-invasive puncture needle or a pressure pump. Each operation requires puncturing the patient's skin to reach the subcutaneous filling device before connecting the balloon catheter to complete the inflation and deflation of the isolation balloon. This means that each balloon inflation and deflation requires repeated trauma to the skin and subcutaneous tissue, not only increasing patient pain and the risk of tissue damage, but also requiring accurate positioning of the puncture membrane during the operation, making the process cumbersome, time-consuming, and even carrying the risk of puncture positioning failure. To address the issue of requiring skin puncture for each procedure, Chinese patent CN120586309B discloses a tissue isolation device with a fluid-filled component embedded in the skin. This device embeds the fluid-filled component on the skin surface, eliminating the trauma of repeated skin punctures and simplifying the operation to be non-invasive. However, the fluid-filled component being located on the body surface increases the risk of detachment, displacement, and infection, and also greatly affects the patient's daily life, such as bathing.

[0005] Therefore, there is an urgent need in the field for a tissue isolation device for use during radiotherapy that does not require repeated skin punctures to connect the infusion equipment, does not easily fall off or shift during use, has a low risk of infection, and is convenient for patients to take baths and perform other daily activities. Summary of the Invention

[0006] The purpose of this invention is to solve the above-mentioned problems and provide a tissue isolation device that is self-circulating and inflatable during radiotherapy. It is completely implanted into the patient's body and will not fall off or shift during use. It can achieve the inflation and deflation of the isolation balloon used to isolate radiotherapy tissue from normal tissue by means of the self-circulation of internal fluid. It is convenient and safe to operate, avoids repeated skin punctures during radiotherapy, reduces the risk of infection, and alleviates patient pain.

[0007] To achieve the above-mentioned objectives of the present invention, the present invention provides a self-circulating tissue isolation device for radiotherapy, for implantation in a patient, comprising: an isolation balloon for placement between the radiotherapy-receiving tissue and the normal tissue requiring protection; a catheter fixedly connected to one end of the isolation balloon; and a liquid supply mechanism fixedly connected to the other end of the catheter and for forming an internal circulating fluid flow path with the isolation balloon; wherein the liquid supply mechanism comprises: a reservoir containing liquid and fixedly connected to the other end of the catheter, the volume of which is larger than the volume of the isolation balloon; and a reservoir disposed on the catheter. The device includes a liquid flow mechanism that enables the fluid to flow from the inner part of the balloon into the isolation balloon or from the isolation balloon into the reservoir. During radiotherapy, in conjunction with the liquid flow mechanism implanted in the patient's subcutaneous tissue, the fluid in the reservoir can flow to the isolation balloon, keeping it inflated and separating the patient's radiotherapy-receiving tissue from normal tissue, thus reducing damage to normal tissue from radiotherapy rays. After radiotherapy, the fluid in the isolation balloon can flow back to the reservoir, allowing the isolation balloon to return to an empty state and reducing pressure on normal tissue.

[0008] Preferably, the liquid flow realization component is a connecting valve that allows the flow path between the isolation balloon and the reservoir to switch between a connected state and a closed state. When it is in the connected state, it allows liquid to flow between the isolation balloon and the reservoir. When it is in the closed state, it can block the flow path between the isolation balloon and the reservoir, so that the isolation balloon is kept in an inflated or deflated state.

[0009] Preferably, the reservoir is a reservoir with internal negative pressure. When the connecting valve is in the connected state, the liquid inside the reservoir can flow into the isolation balloon by pressing the reservoir.

[0010] Preferably, the connecting valve and the reservoir are implanted subcutaneously in the patient's abdomen, and the catheter passes through the abdominal wall into the abdominal cavity, so that the isolation balloon is placed between the radiotherapy tissue and the normal tissue that needs protection in the patient's abdominal cavity.

[0011] Preferably, the connecting valve and the reservoir are embedded in the loose connective tissue and adipose tissue between the superficial fascia and rectus abdominis muscle in the patient's abdomen.

[0012] Preferably, the connecting valve includes: a valve body with a sliding cavity formed inside, and connecting ports connected to corresponding ends of a conduit respectively on its opposite side walls; a sliding valve core with a connecting pipe formed inside and slidably disposed in the sliding cavity of the valve body, which can switch the flow path between a connected state and a closed state when sliding in the sliding cavity; wherein, when the connecting pipe of the sliding valve core corresponds to a pair of connecting ports, the flow path is in a connected state; when the connecting pipe of the sliding valve core is misaligned with a pair of connecting ports, the flow path is in a closed state.

[0013] Preferably, the connecting valve further includes: a reset elastic element, disposed in the sliding cavity of the valve body with its lower end abutting against the bottom of the sliding cavity, for providing elastic force to the sliding valve core to move it upward so that the flow route is switched from the connected state to the closed state; and a pressing part disposed on the sliding valve core, which, by pressing the pressing part, drives the sliding valve core to move downward so that the flow route is switched from the closed state to the connected state.

[0014] Preferably, a limit block is provided at the bottom of the valve body sliding cavity. Pressing the pressing part drives the sliding valve core to move and abut against the limit block, so that the connecting pipeline is connected to the conduit.

[0015] Preferably, the connecting valve is a duckbill valve, which is disposed on the conduit between the isolation balloon and the reservoir.

[0016] Preferably, the storage volume of the reservoir is 15ml-20ml, and the storage volume of the isolation balloon is 10ml-15ml.

[0017] Alternatively, the liquid flow realization component may include a miniature pump for delivering liquid from the reservoir to the isolation balloon or vice versa.

[0018] Preferably, it also includes an external controller disposed outside the body for controlling the micropump to perform corresponding actions.

[0019] Preferably, the liquid flow realization component further includes an in vivo controller implanted in the body and electrically connected to the micropump for receiving signals from the external controller and driving the micropump to operate.

[0020] Preferably, the liquid flow realization component further includes pressure sensors for detecting the pressure inside the reservoir and the isolation balloon, respectively.

[0021] Alternatively, the liquid flow realization component may also include a pressure sensor for detecting the pressure of the isolation balloon on normal tissue.

[0022] Preferably, the micropump is a micro diaphragm pump.

[0023] Compared with the prior art, the tissue isolation device with self-circulating filling and discharging during radiotherapy of the present invention has the following beneficial effects:

[0024] 1. The tissue isolation device of the present invention, which is self-circulating and expandable during radiotherapy, is completely implanted in the patient's body and will not fall off or shift during use. It can achieve the inflation and deflation of the isolation balloon used to isolate radiotherapy tissue from normal tissue by means of the internal fluid circulation and expansion located in the body. It is convenient and safe to operate, avoids repeated skin punctures during radiotherapy, reduces the risk of infection, and alleviates the patient's pain.

[0025] 2. The tissue isolation device for radiotherapy of the present invention has a fluid supply mechanism that is implanted in the patient's body and forms an internal circulation fluid supply path with the isolation balloon. The fluid supply mechanism has a reservoir for supplying fluid to the isolation balloon, which is pre-placed between the patient's radiotherapy tissue and the normal tissue to be protected, and a fluid flow realization component. During the patient's radiotherapy, with the cooperation of the fluid flow realization component, the fluid in the reservoir can flow to the isolation balloon to fill the isolation balloon without the need for external infusion equipment. This avoids the pain and safety hazards caused by repeated external infusion devices or subcutaneous puncture infusion in the prior art, reduces patient skin damage and infection, and is simple to operate, thus improving the radiotherapy efficiency.

[0026] The present invention will now be described in detail with reference to the accompanying drawings. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the first structure of the tissue isolation device for self-circulating filling and discharging during radiotherapy used in radiotherapy according to the present invention;

[0028] Figure 2a This is an exploded view of a connecting valve with the first type of structure used as the liquid flow realization component;

[0029] Figure 2b This is an assembly drawing of a connecting valve with a second-type structure used to achieve liquid flow.

[0030] Figure 3 This is a cross-sectional view of the first type of connecting valve when the flow path is closed.

[0031] Figure 4 This is a cross-sectional view of the first type of connecting valve when the flow path is in a connected state;

[0032] Figure 5 This is a schematic diagram of the structure when the duckbill valve is squeezed;

[0033] Figure 6 This is a schematic diagram of the structure when the duckbill valve is released;

[0034] Figure 7 This is a cross-sectional view of the first type of structural organization isolation device;

[0035] Figure 8 This is a schematic diagram of the structure of the first type of tissue isolation device used during radiotherapy;

[0036] Figure 9 This is a schematic diagram of the second type of tissue isolation device;

[0037] Figure 10 This is a schematic diagram of the third type of tissue isolation device;

[0038] Figure 11 This is a simplified structural diagram of the second type of liquid flow realization component (i.e., including a diaphragm pump);

[0039] Figure 12 This is the first working principle diagram when using a diaphragm pump;

[0040] Figure 13 This is the second working principle diagram when using a diaphragm pump;

[0041] Figure 14 This is a schematic diagram of the liquid flow direction when a diaphragm pump is working. Detailed Implementation

[0042] like Figure 1 , Figures 7-10 The figures show different structural schematic diagrams of the tissue isolation device of the present invention, which is self-circulating and expandable during radiotherapy and is implanted in the patient's body. As shown in the figures, the tissue isolation device of the present invention includes: an isolation balloon 20 for placement between the patient's radiotherapy-receiving tissue and the normal tissue requiring protection; a catheter 10 fixedly connected to one end of the isolation balloon; and a liquid supply mechanism fixedly connected to the other end of the catheter 10 and used to form an internal circulating liquid flow path with the isolation balloon 20. The liquid supply mechanism includes: a reservoir 30 containing liquid and fixedly connected to the other end of the catheter; and a reservoir 30 disposed on the catheter. The tube contains a fluid flow mechanism that allows liquid to flow from the reservoir to the isolation balloon or vice versa. During radiotherapy, the fluid in the reservoir, implanted in the patient's subcutaneous tissue, flows to the isolation balloon, keeping it inflated and separating the radiotherapy-treated tissue from normal tissue, thus reducing damage to normal tissue from radiation. After radiotherapy, the fluid in the isolation balloon flows back to the reservoir, emptying the balloon and reducing pressure on normal tissue.

[0043] The liquid flow realization component of the present invention can be as follows: Figures 1-8 The connecting valve 40 shown can also be as follows: Figures 9-14The integrated pump control component 100 shown below, with reference to the accompanying drawings of the connecting valve and the integrated pump control component, will be described in detail the structure of the tissue isolation device of the present invention that uses different liquid flows to achieve the components.

[0044] Example 1

[0045] like Figure 1 , Figure 7 The figures show a schematic diagram and a cross-sectional view of the tissue isolation device with self-circulating inflation and deflation during radiotherapy in this embodiment. As can be seen from the figures, the liquid flow realization component of the liquid supply mechanism in this embodiment is a connecting valve that can switch the flow path between the isolation balloon and the reservoir between a connected state and a closed state. When it is in the connected state, it can allow liquid to flow between the isolation balloon and the reservoir. When it is in the closed state, it can block the flow path between the isolation balloon and the reservoir, so that the isolation balloon is kept in an inflated or deflated state.

[0046] Specifically, such as Figures 1-8 As shown, the tissue isolation device used in this embodiment for radiotherapy, which is self-circulating and inflatable, includes a catheter 10, an isolation balloon 20, a reservoir 30, and a connecting valve 40. Both the isolation balloon 20 and the reservoir 30 are made of elastic materials that can expand or contract, such as rubber or medical-grade silicone. The reservoir 30 can be an elastic pouch similar to an ear syringe.

[0047] The catheter 10 is capable of conducting fluid, and an isolation balloon 20 is connected to one end of the catheter 10. The isolation balloon 20 can switch between an inflated and deflated state. The isolation balloon 20 is placed between the patient's radiotherapy tissue and the normal tissue that needs protection, such as between an abdominopelvic tumor and the adjacent intestine, to physically isolate the radiotherapy tissue and the normal tissue, thereby reducing the damage of radiation to normal tissue during radiotherapy.

[0048] The reservoir 30 is fixedly connected to the other end of the catheter 10. The reservoir 30 stores liquid and can be under negative pressure after the liquid is squeezed out. In design, the storage volume (i.e., capacity) of the reservoir 30 can be 15ml-20ml, and the liquid can be physiological saline or other medical fluids sufficient to inflate the isolation balloon 20. The storage volume of the isolation balloon 20 can be smaller than that of the reservoir 30, such as 10ml-15ml, to ensure sufficient liquid in the reservoir 30 to inflate the isolation balloon 20. Alternatively, the storage volume of the isolation balloon can be greater than or equal to that of the reservoir. Different sizes of reservoir and isolation balloon capacities can be designed to allow for selection based on actual application needs. Preferably, the reservoir and isolation balloon are detachably fixed to the corresponding catheters, such as by providing connectors for threaded or interference-fitted connections with the catheters, and the connections are sealed with sealing sleeves or sealant.

[0049] like Figure 1 As shown, the connecting valve 40 is disposed on the conduit between the isolation balloon 20 and the reservoir 30, enabling the flow path between the isolation balloon 20 and the reservoir 30 to switch between an open state and a closed state. When the connecting valve 40 keeps the flow path open, it connects the conduit 10 between the isolation balloon 20 and the reservoir 30, allowing liquid to flow between them to inflate or deflate the isolation balloon 20. When the connecting valve 40 keeps the flow path closed, it disconnects the flow path between the isolation balloon 20 and the reservoir 30, preventing the reservoir 30 from being under negative pressure and drawing the liquid back into the isolation balloon 20 after the operator fills the isolation balloon 20 with liquid by squeezing. That is, after the liquid reservoir 30 is squeezed, the flow path between the isolation balloon 20 and the liquid reservoir 30 is immediately disconnected by operating the connecting valve to ensure that the isolation balloon 20 is kept in an inflated state; or, when all the liquid in the isolation balloon 20 flows back to the liquid reservoir 30, the flow path between the isolation balloon 20 and the liquid reservoir 30 is immediately disconnected by operating the connecting valve to ensure that the isolation balloon 20 is kept in an empty state.

[0050] When the isolation balloon 20 is placed between the patient's radiotherapy tissue and the normal tissue requiring protection, it is in its initial state and empty of liquid. Before radiotherapy, with the flow path between the isolation balloon 20 and the reservoir 30 open, the operator squeezes the elastic reservoir 30, injecting its internal liquid into the isolation balloon 20 through the catheter 10. This switches the isolation balloon 20 from its initial empty state to a full state, allowing it to isolate the radiotherapy tissue from the normal tissue. At this time, the elastic reservoir 30 is under negative pressure due to the squeezed liquid. Then, the flow path between the isolation balloon 20 and the reservoir 30 is closed, preventing the liquid in the isolation balloon 20 from flowing back into the reservoir 30. After radiotherapy, the flow path between the isolation balloon 20 and the reservoir 30 is reopened. The negative pressure of the elastic reservoir 30 itself draws the liquid back into the reservoir 30, thus switching the isolation balloon 20 back to its empty state.

[0051] In this embodiment, both the connecting valve 40 and the reservoir 30 can be implanted within the patient's abdominal wall. The catheter 10 passes through the abdominal wall into the patient's abdominal cavity. The isolation balloon 20, connected to the end of the catheter, can be positioned between the radiotherapy tissue and the normal tissue requiring protection within the abdominal cavity. This arrangement allows the entire tissue isolation device to be implanted subcutaneously or internally, with no exposed tubing or components. The patient can move freely without restriction, including activities such as bathing. When radiotherapy requires inflating the isolation balloon 20, the operator can directly press the skin at the locations corresponding to the connecting valve 40 and the reservoir 30 implanted under the patient's skin (in practical applications, markings can be made at the corresponding locations on the skin surface) to connect the flow path of the connecting valve and allow the fluid in the reservoir to flow into the isolation balloon, thus inflating the isolation balloon 20. This avoids the risks of traction, dislodgement, and infection caused by exposed external tubing.

[0052] Preferably, the connecting valve 40 and the reservoir 30 are embedded in the loose connective tissue and adipose tissue between the superficial fascia and rectus abdominis muscle in the patient's abdomen. This ensures that the operator can accurately perceive the location of the connecting valve 40 and the reservoir 30 on the body surface, while also ensuring that the connecting valve 40 and the reservoir 30 have a certain tissue coverage, so that they can be firmly fixed and avoid displacement under the patient's skin after embedding.

[0053] like Figure 2a As shown, the connecting valve 40 includes a valve body 42 and a sliding valve core 44. The valve body 42 is frustoconical in shape and has a sliding cavity 422 inside. The two opposite side walls of the valve body 42 are respectively provided with corresponding connecting ports 424 that penetrate the side walls of the valve body radially. The sliding valve core 44 is slidably disposed in the sliding cavity 422.

[0054] like Figure 3 , Figure 4 As shown, a connecting pipe 442 is formed inside the sliding valve core 44. The sliding valve core 44 slides up and down within the sliding cavity 422, allowing the connecting pipe of the sliding valve core to align with or offset from a pair of connecting ports on the valve body. When the connecting pipe of the sliding valve core corresponds to the pair of connecting ports on the valve body, the connecting valve 40 is in a connected state (i.e., the connecting valve is open), and correspondingly, the flow path between the reservoir and the isolation bulb is in a connected state; when the connecting pipe is completely offset from the pair of connecting ports, the connecting valve 40 is in a closed state (i.e., the connecting valve is closed), and correspondingly, the flow path between the reservoir and the isolation bulb is in a closed state. Therefore, by moving the sliding valve core of the connecting valve up and down within the valve body, the connecting valve 40 can be switched between a connected state and a closed state, thereby switching the flow path between the reservoir and the isolation bulb between a connected state and a closed state.

[0055] During the design process, such as Figure 1 , Figure 2aAs shown, several suture holes 41 can be provided circumferentially on the outer wall of the valve body 42, and these suture holes 41 connect to the bottom of the valve body 42. The operator can suture and fix the valve body 42 subcutaneously to the patient through the suture holes 41, thereby preventing displacement of the valve subcutaneously. The number of suture holes 41 can be set according to actual needs. Or, as... Figure 2b As shown, a thin convex edge 427 protruding outward along the radial direction is also provided at the bottom of the valve body 42. Several suture holes 41 penetrating the thickness of the convex edge are provided on the convex edge. The operator can suture and fix the valve body 42 under the patient's skin through the suture holes 41.

[0056] Furthermore, such as Figures 2a-4 As shown, the connecting valve 40 also includes a reset elastic element 46 made of elastic material. The reset elastic element 46 is disposed in the sliding cavity 422 of the valve body and located between the sliding valve core 44 and the bottom of the sliding cavity 422. When the top of the sliding valve core is not subjected to external pressure, the reset elastic element 46 can provide the sliding valve core 44 with an elastic force that switches the sliding valve core 44 from the connected state to the closed state. That is, under the action of the restoring force of the reset elastic element, the sliding valve core returns to the initial position where the connecting pipe and the pair of connecting ports of the valve body are misaligned.

[0057] Furthermore, a pressing part 444 is provided on the top of the sliding valve core 44. The diameter of the pressing part is larger than the outer diameter of the sliding valve core and the inner diameter of the valve body sliding cavity. By pressing the pressing part 444 downward, the sliding valve core 44 can be driven to move downward in the valve body sliding cavity, thereby switching the connecting valve from the closed state to the connected state.

[0058] Among them, such as Figure 3 As shown, at this time, the connecting valve is in its initial closed state, and the connecting pipe 442 of the sliding valve core 44 is offset from the pair of connecting ports 424 of the valve body 42, that is, it is offset from the conduits 10a and 10b located on both sides of the valve body. Figure 4 As shown, when the operator presses the pressing part 444, causing the sliding valve core 44 to move to a certain position in the direction indicated by arrow A, the reset elastic element 46 is compressed, the connecting tube 442 corresponds to the connecting port 424 of the valve body 42, and the sliding valve core 44 switches to the connected state, thus connecting the catheter 10 between the isolation balloon 20 and the reservoir 30. When it is necessary for the connecting valve 40 to return to the disconnected state, the operator only needs to release the pressing part 444, and under the action of the reset elastic element 46, the sliding valve core 44 automatically returns to its initial state. The entire operation can be completed with just a simple pressing and releasing action, without the need for additional instruments, greatly improving the convenience of clinical use.

[0059] To prevent leakage after the connecting valve 40 connects to the two conduits, a seal is provided between the sliding valve core 44 and the sliding cavity 422. Specifically, such as... Figure 2aAs shown, axially extending embedding grooves are respectively provided at the positions of the two connecting ports 424 corresponding to the valve body 42 on the inner wall of the sliding cavity 422 (the width of the embedding groove is greater than the diameter of the connecting port, and the height of the embedding groove is the same as or less than the height of the valve body). An elastic pad 426 made of elastic material (such as the material used to make sealing rings) is embedded in each embedding groove. The elastic pad 426 has a connecting opening at the position corresponding to the connecting port 424. When the sliding valve core 44 slides in the sliding cavity, so that the connecting pipe 442 corresponds to a pair of connecting ports 424 of the valve body, and the flow paths of the reservoir and the isolation balloon are connected, the elastic pad 426 can play a sealing role between the sliding valve core and the valve body. Alternatively, a structure of the prior art that can seal the passage formed by aligning the sliding valve core connecting pipe with a pair of connecting ports can also be used, which will not be described in detail here.

[0060] like Figure 3 , Figure 4 As shown (elastic pad not shown), a limiting block 428 is provided at the bottom of the sliding cavity 422. When the operator presses down on the pressing part 444, it causes the sliding valve core 44 to move downward within the sliding cavity of the valve body and abut against the limiting block 428. This indicates that the sliding valve core 44 has slid to the appropriate position, at which point the pair of connecting ports of the connecting valve 40 are precisely aligned with and fully connected to the connecting pipe of the sliding valve core. The setting of the limiting block 428 not only provides the operator with clear feedback on pressing to stop, but also ensures that each press can connect the connecting valve 40, avoiding misoperation caused by insufficient or excessive movement of the sliding valve core 44. In the design, the height of the limiting block is equal to the displacement that the sliding valve core can move to fully align the connecting pipe with the connecting port.

[0061] Alternatively, the connecting valve 40 can also be as follows: Figure 5 , Figure 6 The duckbill valve 90, shaped like a duckbill, is laterally positioned on the conduit 10 between the isolation balloon 20 and the reservoir 30, meaning its axis is parallel to the conduit's axis. In design, both ends of the duckbill valve can be seamlessly connected to the conduits on either side of the isolation balloon 20 and the reservoir 30 (e.g., through integral molding or bonding), or the duckbill valve can be placed inside the conduit with one end fixedly connected to the conduit's inner wall. Either the large-diameter or small-diameter end of the duckbill valve can be aligned with the reservoir, and the inner cavity of the small-diameter end can communicate with or be closed to the inner cavity of the large-diameter end. In design, the small-diameter end is made of an elastic material, and initially, the inner walls of the small-diameter end are fitted together to close the inner cavity. During use, the operator only needs to follow... Figure 5 Pinch the duckbill valve 90 near the small diameter end inside the catheter 10 in the direction indicated by the middle arrow. This will establish communication between the inner cavity of the small diameter end of the duckbill valve 90 and the inner cavity of the large diameter end, thus connecting the flow path between the isolation balloon 20 and the reservoir 30. Releasing the duckbill valve 90 will automatically close it, thus sealing the flow path between the isolation balloon 20 and the reservoir 30.

[0062] Of course, those skilled in the art should understand that the connecting valve 40 can be any structure that can be implanted under the patient's skin and whose flow path can be opened or closed by pressing or squeezing. For example, a rubber valve used in an alkaline burette. Correspondingly, a section of the catheter 10 near the opening of the reservoir 30 can be replaced with a section of rubber tubing, inside which is a glass bead of a suitable size. When the operator squeezes the rubber tubing with their finger, a gap is created between the glass bead and the wall of the rubber tubing, thus opening the flow path; releasing the squeeze closes the flow path.

[0063] The following describes the usage process of the tissue isolation device in this embodiment:

[0064] 1) such as Figure 7 , Figure 8 As shown, the tissue isolation device of this embodiment is implanted via laparoscopic surgery before radiotherapy. The isolation balloon 20 is placed between the patient's radiotherapy tissue 70 and normal tissue 80. The catheter 10 is extended so that the connecting valve 40 and the reservoir 30 at the other end are embedded in the patient's abdominal wall 50. Preferably, they are embedded in the loose connective tissue and adipose tissue between the superficial fascia and rectus abdominis muscle in the patient's abdomen.

[0065] 2) Before radiotherapy is performed on the tissue 70 within the patient's abdominal and pelvic cavity (60), the operator presses the abdominal skin at the location corresponding to the connecting valve 40 within the abdominal wall (50) to connect the valve 40, thus connecting the flow path between the reservoir 30 and the isolation balloon 20. Simultaneously, downward pressure is applied to the skin corresponding to the location of the reservoir 30 within the abdominal wall (50), allowing the fluid in the reservoir 30 to flow through the catheter 10 and the connecting valve 40 to inflate the isolation balloon 20. During the procedure, the patient can cooperate by forcefully "blowing out" their abdomen, causing tension in the rectus abdominis muscles to provide a firm "base" for the connecting valve 40 and the reservoir 30, facilitating compression and other operations.

[0066] 3) After inflation is complete, release the connecting valve 40. The connecting valve 40 returns to the open state. Correspondingly, the flow path between the reservoir 30 and the isolation balloon 20 is closed. At this time, the isolation balloon maintains the inflation state and separates the radiotherapy tissue from the normal tissue, and the radiotherapy operation can begin.

[0067] 4) After the radiotherapy procedure is completed, to prevent the inflated isolation balloon 20 from causing excessive compression or traction on surrounding tissues over a long period, the operator needs to press the corresponding position of the connecting valve 40 again to reconnect it, thus reconnecting the flow path between the reservoir 30 and the isolation balloon 20. At this time, under the negative pressure suction of the reservoir 30, the liquid in the isolation balloon 20 is drawn back into the reservoir 30 along the catheter 10, and the isolation balloon 20 switches back to the empty state. Then, the connecting valve 40 is released again, disconnecting the flow path between the reservoir 30 and the isolation balloon 20, and the isolation balloon remains in the empty state.

[0068] When radiotherapy is required again, the operator only needs to repeat the above steps 2)-4) to complete the inflation and deflation of the isolation balloon 20. The whole operation is not only convenient and quick, but also does not require repeated external infusion devices or repeated subcutaneous puncture infusion operations, which greatly ensures the safety of patients and reduces their pain.

[0069] The time interval between opening and closing of the connecting valve 40 can be determined in advance or by existing technical means.

[0070] Example 2

[0071] like Figures 9-14 The figures show different structural diagrams and control principle diagrams of the tissue isolation device in this embodiment. As can be seen from the figures, the structure of this embodiment is basically the same as that of Embodiment 1, including a reservoir, an isolation balloon, and a conduit. The difference is that the liquid flow realization component in this embodiment does not use the connecting valve of Embodiment 1, but includes a miniature pump for transporting the liquid in the reservoir to the isolation balloon or the liquid in the isolation balloon to the reservoir. Furthermore, the reservoir containing the liquid may not have negative pressure relative to the isolation balloon.

[0072] In this embodiment, a micro-pump is used to transport the liquid in the reservoir to the isolation balloon or the liquid in the isolation balloon to the reservoir. Compared with the first embodiment, this embodiment does not require squeezing the connecting valve and the reservoir on the patient's body surface, thereby avoiding discomfort to the patient.

[0073] Specifically, such as Figures 9-14As shown, the liquid flow realization component in this embodiment includes a micropump 102, an external controller 200, and an internal controller 103. The external controller and the internal controller communicate wirelessly in two directions. The external controller, placed outside the patient, sends commands to the internal controller implanted inside the patient. The internal controller receives the commands and controls the micropump implanted inside the patient to start or stop according to the commands. After the micropump starts, it can pump the liquid in the reservoir into the isolation balloon, or it can pump the liquid in the isolation balloon back into the reservoir, thereby inflating or emptying the isolation balloon through the micropump. After the micropump stops, the pumping of liquid in the reservoir and the isolation balloon can be stopped, so that the isolation balloon is maintained in an inflated or emptied state.

[0074] In this embodiment, the micropump is a medically implantable micropump capable of bidirectional fluid delivery, such as a bidirectional diaphragm pump. During assembly, the bidirectional diaphragm pump is mounted on a conduit connecting the reservoir and the isolation balloon. Specifically, the first fluid interface of the bidirectional diaphragm pump is sealed to the first conduit 10a connecting the isolation balloon, and the second fluid interface of the bidirectional diaphragm pump is sealed to the second conduit 10b connecting the reservoir. Thus, a flow path for fluid flow is formed by the sequentially connected reservoir, second conduit, bidirectional diaphragm pump, first conduit, and isolation balloon.

[0075] During the design phase, the bidirectional diaphragm pump is fixedly installed within the housing 100, which can be cylindrical (e.g., ...). Figure 9 As shown), a square shape can also be used (such as...). Figure 10 As shown, the first and second fluid ports of the bidirectional diaphragm pump can extend out of the housing for easy connection to the conduits on both sides. The in vivo controller is also fixedly installed inside the housing and is electrically connected to the bidirectional diaphragm pump. In addition, the housing also houses components such as a power supply for providing power to the in vivo controller and the bidirectional diaphragm pump (not shown in the figure).

[0076] In this embodiment, the housing and reservoir containing the various components are embedded in the patient's abdominal wall, preferably within the loose connective tissue and adipose tissue between the superficial fascia and rectus abdominis muscle in the patient's abdomen. To prevent displacement of the housing under the skin, several suture holes 101 can be provided on the outer wall of the housing (see [reference]). Figure 9 The shell can be sutured and fixed under the patient's skin through suture holes and sutures, and the number and location of the suture holes can be set according to actual needs.

[0077] Before the radiotherapy begins, the external controller sends a signal to the internal controller. The internal controller receives the signal and controls the micropump (such as the bidirectional diaphragm pump mentioned above) to work. After the micropump is started, it pumps the liquid in the reservoir into the isolation balloon, so that the isolation balloon is filled and separates the radiotherapy tissue from the normal tissue.

[0078] In order to prevent the pressure of the inflated isolation balloon on normal tissue from being too great and damaging normal tissue or surrounding blood vessels, the degree of inflation of the isolation balloon can be determined according to the specific situation between the radiotherapy tissue and normal tissue in different patients. The degree to which the radiotherapy tissue and normal tissue can be separated can be determined according to the working time of the micropump. The working time of the micropump and the volume of liquid that can be pumped within the corresponding time can be determined in advance by experiments.

[0079] Once the required fluid volume has been reached within the isolation balloon (i.e., after the preset operating time), the external controller sends a signal to the internal controller to stop the micropump. The external controller can be set to operate the micropump for multiple durations. During this time, the isolation balloon remains inflated, ensuring that the treated tissue remains separated from normal tissue throughout radiotherapy, protecting the normal tissue without causing damage. After radiotherapy, the external controller sends a signal to the internal controller to restart the micropump. Upon restarting, the micropump pumps the fluid from the isolation balloon back into the reservoir, emptying the isolation balloon and preventing further compression of normal tissue.

[0080] Or, such as Figure 13 As shown, a first pressure sensor for detecting the pressure exerted by the isolation balloon on normal tissue can be installed on the isolation balloon. This first pressure sensor can be fixedly installed on the inner wall of the isolation balloon facing the normal tissue, or on the outer wall of the isolation balloon that contacts the normal tissue, or it can be fixed inside the first catheter. Correspondingly, the external controller also has a display screen that can display the pressure in real time. Specifically, a reasonable pressure on the normal tissue after the isolation balloon is inflated is determined in advance based on experiments, i.e., a first preset pressure threshold; and the pressure of the isolation balloon in its initial deflated state (i.e., atmospheric pressure) is set as a second preset pressure threshold.

[0081] After the micropump operates to allow fluid to flow into the isolation balloon, a first pressure sensor detects the pressure of the isolation balloon on the normal tissue in real time and transmits this pressure value to the in vivo controller and / or the external controller. The in vivo controller and / or the external controller compares this pressure value with a first preset pressure threshold. If the detected pressure value reaches the first preset pressure threshold, the in vivo controller controls the micropump to stop operating. Then, the isolation balloon will maintain the current pressure on the normal tissue during radiotherapy.

[0082] When the micropump operates and the liquid inside the isolation balloon flows into the reservoir, the first pressure sensor detects the pressure inside the isolation balloon in real time and transmits the pressure value to the in vivo controller and / or the external controller. The in vivo controller and / or the external controller compares the pressure value with the second preset pressure threshold. If the detected pressure value reaches the first preset pressure threshold, the in vivo controller controls the micropump to stop working. At this time, the isolation balloon will be in an empty state and will not compress normal tissue.

[0083] The following describes the usage process of a tissue isolation device having a first pressure sensor and transmitting the pressure detected by the first pressure sensor to the in vivo controller, as an example:

[0084] 1) Before radiotherapy, the tissue isolation device of this embodiment is implanted by laparoscopic surgery. The isolation balloon is placed between the patient's radiotherapy tissue and normal tissue. The first catheter 10a connected to the isolation balloon extends so that the housing containing components such as a micro pump, the second catheter 10b connected to the housing, and the reservoir connected to the second catheter are buried in the patient's abdominal wall. Preferably, the above components are buried in the loose connective tissue and adipose tissue between the superficial fascia and the rectus abdominis muscle in the patient's abdomen.

[0085] 2) Before radiotherapy is administered to the tissues in the patient's abdominopelvic cavity, the operator sends a signal to the internal controller via the external controller to rotate the micropump. Upon receiving the signal, the internal controller controls the micropump to rotate forward, pumping liquid from the reservoir into the isolation balloon, causing the balloon to inflate (or fill) and isolate the treated tissue from the normal tissue. During the rotation of the micropump, a first pressure sensor continuously monitors the pressure inside the isolation balloon and transmits this pressure to the internal controller. The internal controller compares the received pressure value with a first preset pressure threshold. If the pressure reaches the first preset threshold, the internal controller stops the micropump, and the liquid from the reservoir will no longer be pumped into the isolation balloon.

[0086] 3) After the micro-pump stops working, radiotherapy can begin. The isolation balloon will maintain its current pressure and remain inflated throughout the radiotherapy process to separate the radiotherapy tissue from the normal tissue.

[0087] 4) After the radiotherapy procedure is completed, the operator sends a signal to the internal controller via the external controller to reverse the micropump. Upon receiving the signal, the internal controller controls the micropump to reverse, pumping the fluid from the isolation balloon into the reservoir, thus emptying the isolation balloon and preventing further compression of normal tissue. During the micropump reversal process, the first pressure sensor monitors the pressure inside the isolation balloon in real time and transmits the pressure to the internal controller. The internal controller compares the received pressure value with a second preset pressure threshold. If the pressure value reaches the second preset pressure threshold, the internal controller stops the micropump, and the fluid from the isolation balloon will no longer be pumped into the reservoir.

[0088] When radiotherapy is required again, the operator simply repeats steps 2)-4) above. The external controller, operated outside the patient's body, inflates and deflates the isolation balloon, thus isolating the radiotreated tissue from normal tissue and relieving pressure on the normal tissue. The entire procedure is convenient and quick, requiring no abdominal pressure and greatly reducing patient discomfort.

[0089] Although the present invention has been described in detail above, the present invention is not limited thereto. Those skilled in the art can make modifications based on the principles of the present invention. Therefore, all modifications made in accordance with the principles of the present invention should be understood as falling within the protection scope of the present invention.

Claims

1. A self-circulating, deflated tissue isolation device for radiotherapy, for implantation in a patient, comprising: An isolation balloon used to place between the tissues receiving radiation therapy and the normal tissues that need protection in a patient; A catheter that is fixedly connected to an isolation balloon at one end; A fluid supply mechanism that is fixedly connected to the other end of the catheter and is used to form an internal circulation flow path for filling and discharging fluid with the isolation balloon; The liquid supply mechanism includes: A reservoir containing liquid and fixedly connected to the other end of a conduit; A liquid flow realization component installed on the conduit that enables liquid to flow from the reservoir to the isolation balloon or vice versa; In this system, under the synergistic effect of the fluid flow realization component implanted in the patient's subcutaneous tissue, during radiotherapy, the fluid in the reservoir implanted in the patient's subcutaneous tissue can flow to the isolation balloon, so that the isolation balloon is inflated and isolates the patient's radiotherapy-receiving tissue from normal tissue, thereby reducing the damage of radiotherapy rays to normal tissue; after radiotherapy, the fluid in the isolation balloon can flow back to the reservoir, so that the isolation balloon returns to an empty state and reduces the compression on normal tissue.

2. The tissue isolation device according to claim 1, wherein the liquid flow realization component is a connecting valve that allows the flow path between the isolation balloon and the reservoir to switch between a connected state and a closed state. When it is in the connected state, it allows liquid to flow between the isolation balloon and the reservoir. When it is in the closed state, it can block the flow path between the isolation balloon and the reservoir, so that the isolation balloon is maintained in an inflated or deflated state.

3. The tissue isolation device according to claim 2, wherein the reservoir is a reservoir in a negative pressure state, and when the connecting valve is in the connected state, the liquid inside the reservoir can flow into the isolation balloon by pressing the reservoir.

4. The tissue isolation device according to claim 2 or 3, wherein the connecting valve comprises: The valve body has a sliding cavity inside, and its two opposite side walls have communication ports that connect to the corresponding ends of the conduit. A sliding valve core with an internal connecting pipe and slidably disposed in the sliding cavity of the valve body can switch the flow path between a connected state and a closed state when it slides in the sliding cavity. When the connecting pipe of the sliding valve core corresponds to a pair of connecting ports, the flow path is in a connected state; when the connecting pipe of the sliding valve core is misaligned with a pair of connecting ports, the flow path is in a closed state.

5. The tissue isolation device according to claim 4, wherein the connecting valve further comprises: A reset elastic element is placed in the sliding cavity of the valve body and its lower end abuts against the bottom of the sliding cavity. It is used to provide the sliding valve core with an elastic force to move it upward so that the flow route switches from the connected state to the closed state. The pressing part provided on the sliding valve core can be pressed to move the sliding valve core downward, thereby switching the flow route from a closed state to a connected state.

6. The tissue isolation device according to claim 1, wherein the connecting valve is a duckbill valve disposed on the conduit.

7. The tissue isolation device according to claim 1, wherein the liquid flow realization component includes a micropump for conveying liquid in the reservoir to the isolation balloon or conveying liquid in the isolation balloon to the reservoir.

8. The tissue isolation device according to claim 7, characterized in that, It also includes an external controller located outside the body to control the micropump to perform corresponding actions.

9. The tissue isolation device according to claim 8, characterized in that, The liquid flow realization component also includes an in vivo controller implanted in the body and electrically connected to the micropump for receiving signals from the external controller and driving the micropump to operate.

10. The tissue isolation device according to any one of claims 7-9, characterized in that, It also includes a pressure sensor for detecting the pressure of the isolation balloon on normal tissue.

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