A tissue isolation device for embedding a fluid-filled component in skin

Abstract

A kind of tissue isolator instrument of liquid-filled component embedding in skin, including isolation balloon, liquid-filled structure and fixed structure, isolation balloon includes balloon body and connecting pipe;Liquid-filled structure includes port body, closure structure and connecting head;Port body has cavity inside, and the tail end of cavity is equipped with closure structure, such as puncture film or closed valve structure;Port body other end is provided with connecting head, and connecting head can be extended into and communicate with the connecting pipe of isolation balloon;Liquid-filled structure and connecting pipe are detachably connected;Fixed structure is arranged in the middle of port body, and is provided with suture hole on it, and the side of it facing skin is provided with adhesive layer, and is fixed on the surface of skin around incision by suture and adhesive.The above setting embeds and fixes the liquid-filled structure of the instrument on the surface of skin, and can be completed under direct vision balloon filling and discharging operation, greatly reduces the size of liquid-filled structure, reduces surgical incision and patient trauma;At the same time, it can avoid repeatedly cutting skin within a short time for implanting and removing balloon.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a tissue isolation device with a liquid-filled component embedded in the skin. BACKGROUND

[0002] Tumor radiotherapy is a local treatment method for treating tumors using radiation. The biggest problem in tumor radiotherapy is the effective protection of adjacent normal organs and tissues, especially those sensitive to radiation, such as the intestinal tract, glands, and lymph nodes. Radiation inevitably causes damage to normal tissues while killing tumor cells, which can result in various serious and irreversible complications.

[0003] The prior art CN116440428A - A implantable tissue isolation device that can be repeatedly filled and discharged in the body discloses an isolation balloon, a soft connecting tube, and a filling connection structure. The isolation balloon can separate the radiotherapy tissue from the normal tissue, reducing the radiation dose to the normal tissue and thus playing a protective role. Traditional radiotherapy usually takes 2-3 months. If the liquid-filled structure of the isolation device is placed on the body surface for a long time, the risk of infection, displacement, and shedding is high, and it will have a great impact on the daily life of the patient (such as bathing, swimming, etc.). Therefore, the prior art CN116440428A chooses to implant the device completely in the body, and the filling connection structure is buried under the skin. The implantation and removal process of the balloon is fast and minimally invasive, but after the radiotherapy is completed, the skin tissue needs to be cut again to remove the isolation device.

[0004] In recent years, with the progress of radiotherapy technology, hypofractionated radiotherapy has been increasingly widely used. Its characteristics are that the treatment period is greatly shortened, and radiotherapy can be completed within 1-2 weeks. With the progress of technology, the cycle of hypofractionated radiotherapy will become shorter and shorter. If the isolation device corresponding to the prior art CN116440428A is applied to hypofractionated radiotherapy, the isolation balloon needs to be implanted and removed twice by cutting the skin within 1-2 weeks, which causes great damage to the tissue and is prone to wound infection, poor healing, and scarring. Based on the advantage of short cycle of hypofractionated radiotherapy, it is possible to embed the liquid-filled component on the surface of the skin to avoid repeated incision of the skin. Within 1-2 weeks, the risk of displacement and infection of the liquid-filled component is not high under the condition of good fixation and sealing. The time of the impact on the daily life of the patient is also short. Another advantage of embedding the liquid-filled component on the body surface is that the liquid filling operation can be performed under direct vision, which greatly reduces the size of the puncture membrane and the liquid-filled component, that is, greatly reduces the skin incision and trauma.

[0005] Therefore, the present application discloses a tissue isolation device with a liquid-filled component embedded in the skin to solve the above problems. SUMMARY

[0006] Traditional radiotherapy mode usually needs a treatment cycle of 6-10 weeks, plus the time of preoperative recovery, positioning and radiotherapy planning of the patient, the whole radiotherapy cycle usually needs 2-3 months. The prior art CN116440428A-a kind of implantable in vivo repeated tissue isolation device, the liquid filling component is buried in the skin, perfectly solves the problem of infection and device shedding risk, and the isolation device is completely implanted in the body, which has little effect on the daily life of the patient. But this technology also has two disadvantages: 1, the balloon needs to be cut again when it is removed; 2, the liquid filling component is located in the skin, in order to improve the puncture success rate, the liquid filling component and the puncture film need larger size (10mm), which requires larger skin incision (12-15mm) for complete device implantation.

[0007] The cycle of large fraction radiotherapy is only 1-2 weeks, and if the prior art CN116440428A is used, the isolation balloon implantation and removal need to cut the skin repeatedly within 1-2 weeks, which causes great trauma to the patient and is prone to wound infection and poor healing, and large scars are easily caused after operation; therefore, the present application expects to set a liquid filling component embedded in the skin and exposed on the body surface, and a fixing structure is arranged on the liquid filling component, the liquid filling component is fixed to the skin around the incision by the fixing structure and the incision is sealed, and the liquid filling component is partially embedded in the skin incision and partially exposed on the body surface. Because the tail end of the liquid filling component is exposed on the body surface, the entire liquid filling operation can be completed under direct vision, which can significantly reduce the size of the puncture film and the liquid filling component, which means smaller skin incision. At the same time, in the case of good fixation and sealing, the risk of displacement and infection of the liquid filling component is not high in 1-2 weeks, and the influence on the daily life of the patient is also short. In addition, a larger annular sealing film can be added outside the fixing structure to further strengthen the fixation and sealing and reduce the risk of device infection and displacement.

[0008] The present application discloses a liquid filling component embedded in the skin and a tissue isolation device with the liquid filling component embedded in the skin, which is mainly applied to patients with large fraction radiotherapy, and the advantages include: 1, avoiding the need to cut the skin repeatedly within a short time for isolation balloon implantation and removal, reducing the risk of tissue trauma and infection; 2, the balloon is filled and discharged under direct vision, the size of the liquid filling component is significantly reduced, and the size of the skin incision and the trauma to the patient are reduced.

[0009] The specific technical scheme is as follows: the application discloses a liquid-filled component embedded on the surface of skin, which comprises a liquid-filled structure and a fixing structure; the liquid-filled structure comprises a harbor body, a closed structure and a connecting head; the harbor body has a cavity inside, the first end of the harbor body is exposed outside the body, the closed structure is used for plugging the cavity inside the harbor body, and the closed structure is located at the first end of the harbor body; the connecting head is arranged at the second end of the harbor body, the connecting head has a through cavity, the first end of the connecting head is communicated with the cavity inside the harbor body, the second end of the connecting head is communicated with the connecting pipe of the isolation balloon, and the connecting head and the connecting pipe of the isolation balloon are detachably connected.

[0010] The fixing structure is used for fixing the liquid-filled component by being fixed on the surface of skin, the fixing structure is connected with the outer side wall of the harbor body, is arranged at a position between the first end and the second end of the harbor body and is fixed relative to the longitudinal axis of the harbor body, and the fixing structure divides the harbor body into a first part exposed outside the body and a second part embedded in the skin incision.

[0011] Further, the fixing structure is a fixing sheet arranged on the outer side wall of the harbor body, one surface of the fixing sheet in contact with the skin is provided with an adhesive layer, and a suture hole is arranged on the fixing sheet, so that the fixing structure is fixed on the body surface by means of adhesion and suturing, and the adhesion can also seal the skin incision.

[0012] Further, the fixing sheet is a ring-shaped disc arranged to extend outward around the harbor body by 360 degrees, and the adhesive layer is a ring-shaped layer with a length of 360 degrees. In this way, 100% protection of the skin incision can be ensured, and once the bacteria in the external environment interfere with the incision, the risk of infection caused by exposure of the wound can be avoided.

[0013] Further, on the basis of the adhesive layer arranged on the fixing sheet, a plurality of suture holes are arranged through the outer edge of the fixing sheet and are evenly arrayed on the edge of the fixing sheet. In use, the fixing structure is sutured on the skin by passing the suture through the suture hole, and the fixation of the fixing structure is further strengthened; through the above arrangement, the fixing sheet can be most firmly arranged on the body surface, and the risk that the adhesive layer is separated from the skin and the wound is exposed to the environment due to accidental touch during wearing of the liquid-filled component can be most avoided. In addition, a ring-shaped sealing film with a larger outer diameter can be further arranged outside the fixing structure, which is similar to the commonly used dynamic blood glucose meter reinforcing film, infusion film and the like in clinical practice, so as to further strengthen the fixation and sealing and most avoid the risk of device-related infection and displacement.

[0014] The application also discloses a tissue isolation instrument with a liquid-filled component embedded in skin, which comprises an isolation balloon and the liquid-filled component, the isolation balloon comprises a balloon body and a soft connecting pipe which are in communication with each other, and the connecting head of the liquid-filled component is inserted into the connecting pipe of the isolation balloon to realize the communication between the cavity in the port body and the balloon body of the isolation balloon, and the liquid-filled structure and the connecting pipe are detachably connected.

[0015] The above arrangement can expose the liquid-filled structure on the body surface, and the isolation balloon is first sent to a suitable position in the body during use, and the length of the connecting pipe can be adjusted by cutting if the length is too long, so that the length can be combined with the liquid-filled component, and the liquid-filled component is fixed on the body surface; after the length of the connecting pipe is set, the connecting pipe and the liquid-filled component are connected, and after the connecting pipe and the liquid-filled component are connected, the second part of the liquid-filled component is embedded in the skin incision, and the first part of the liquid-filled component is exposed on the body surface, and then the adhesive layer of the fixing structure is attached to the skin around the incision and is sutured to the skin through the suture hole by using a suture to reinforce, so that the fixing of the liquid-filled structure and the sealing of the skin incision are completed; in this way, when the balloon body of the isolation balloon is inflated or retracted, only the liquid filling or extraction is needed after the puncture needle is used to pierce the closed structure or a specific device is used to communicate the closed valve.

[0016] One embodiment is to place the isolation balloon through body surface puncture, in this way, a filling channel and a positioning channel are arranged in the connecting pipe, and the liquid-filled structure further comprises a plug, the plug is arranged at the second end of the port body and is parallel to the connecting head; the connecting head is inserted into the filling channel, and the plug is inserted into the positioning channel. This arrangement can ensure effective plugging of the positioning channel.

[0017] Further, the port body is cylindrical, and the outer diameter of the port body ranges from 5 mm to 15 mm. The outer diameter is not larger than the size of the incision constructed during puncture, and the size of the skin incision does not need to be additionally increased due to the arrangement of the liquid-filled component.

[0018] Further, the fixing sheet is arranged perpendicularly to the longitudinal axis of the port body, and the length of the first part is less than or equal to 10 mm. This distance can ensure that even if a part is exposed on the body surface, the small outer diameter and the small exposed length can ensure the normal life of the patient, and the arrangement of the liquid-filled assembly does not affect the life of the patient.

[0019] Advantages of the application

[0020] By setting the connection mode of the fixed structure and the port body and setting the adhesive layer and the suture hole on the fixed structure, effective fixation and adhesion of the fixed structure and the skin during use can be achieved, thereby achieving the purpose of fixing the liquid-filled component, and the first part of the port body is stably arranged outside the body, and the second part of the port body is stably embedded into the skin incision. The effect of avoiding repeated incision of the skin in a short time for the mode of large split radiotherapy is achieved, and because the first part is exposed outside the body, the outer diameter of the port body is greatly reduced, and the size of the skin incision is reduced. The purpose is achieved. The placement and operation of the entire liquid-filled component are more simple, and the demand for short-term use can be met to the greatest extent.

[0021] By setting the fixed sheet to a 360-degree fixed disc and setting the adhesive layer to a 360-degree adhesive layer, the purpose of fixing the fixed disc around the skin incision can be effectively achieved, and a sealing effect can be achieved, so that the incision is isolated from the external environment, and the purpose of avoiding wound infection is ultimately achieved.

[0022] By setting the suture hole, the disengagement of the fixed structure of the liquid-filled structure liquid-filled component during use due to external force such as accidental touch can be avoided.

[0023] By setting the length of the first part of the port body to be less than or equal to 10 mm, the port body first part has a small outer diameter and a small exposed length, so that even if the liquid-filled assembly is set, accidental touch will not have a great impact on the liquid-filled component, thereby ensuring the normal life of the patient and achieving an effect similar to implantation. BRIEF DESCRIPTION OF DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor. Among them:

[0025] Figure 1 It is a schematic diagram of the overall structure of the isolator;

[0026] Figure 2 It is a schematic diagram of the isolation balloon structure provided with a support rod in embodiment 1;

[0027] Figure 3 It is a schematic diagram of the structure of the isolation balloon in embodiment 1;

[0028] Figure 4 It is a schematic diagram of the cross-sectional structure of the part of the connecting pipe and the liquid-filled component separated from the connecting pipe in embodiment 1;

[0029] Figure 5 It is a schematic diagram of the structure of the liquid-filled component in embodiment 1;

[0030] Figure 6 Structure diagram of the liquid-filled structure of Example 1

[0031] Figure 7 Structure diagram of the cross-section of the liquid-filled component of Example 1 as a closed valve;

[0032] Figure 8 Structure diagram of the liquid-filled component of Example 2 in a separated state from the isolation balloon;

[0033] Figure 9 Structure diagram of the cross-section of the liquid-filled component of Example 2;

[0034] In the figure, 1, liquid-filled component; 11, liquid-filled structure; 111, port body; 1111, cavity; 1112, first part; 1113, second part; 1121, puncture membrane; 1122, closed valve; 113, connecting head; 114, plugging head; 12, fixing sheet; 121, adhesive layer; 122, suture hole; 2, isolation balloon; 21, connecting tube; 211, inflation channel; 212, positioning channel; 22, balloon body; 23, positioning rod. DETAILED DESCRIPTION

[0035] In this article, unless otherwise explicitly specified and limited, the terms "first", "second" are only used for the purpose of description, and cannot be understood as indicating or implying relative importance; unless otherwise specified or explained, the term "multiple" refers to two or more; the terms "connection", "fixation" and the like should be understood broadly, for example, "connection" can be fixed connection, or detachable connection, or integrally connected, or electrically connected; it can be directly connected, or indirectly connected through an intermediate medium. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0036] Example 1

[0037] Reference Figures 1-7 A tissue isolation device embedded in the skin by percutaneous puncture implantation of a liquid-filled component 1 includes a liquid-filled component 1 and an isolation balloon 2.

[0038] Reference Figures 1-3; the isolation balloon 2 comprises a balloon body 22 and a connecting tube 21 which are in communication with each other; wherein the connecting tube 21 is provided with a filling channel 211 and a positioning channel 212; wherein a hard support rod can be inserted into the positioning channel 212, which is used to guide the isolation balloon 2 to enter the appropriate position and rotate to the accurate isolation angle. The cooperation of the hard support rod and the positioning channel 212 is the same as that of CN116440428A- A kind of implantable tissue isolation device that can be repeatedly filled and discharged in vivo, the positioning channel 212 is a non-circular channel, and the corresponding support rod is a non-circular rod body. The function of the positioning channel 212 is to pass the support rod to complete the positioning of the balloon body 22. After the medical staff inserts the support rod through the positioning channel 212 into the unexpanded balloon body 22, the isolation balloon 2 sleeved on the support rod is pushed inward from the incision on the patient's body surface through the pre-placed sheath tube, so that the balloon body 22 moves to the radiotherapy tissue and the normal tissue, and then the balloon body 22 is filled with special liquid through the filling channel 211, so that the balloon is filled. This process is usually completed under the guidance of ultrasound, and the position and angle of the balloon can be adjusted by the support rod. After the positioning is satisfied, the hard support rod is withdrawn from the patient's body, the function of the positioning channel 212 disappears, and the positioning channel 212 is not connected with the filling channel 211, so as to avoid that the liquid injected into the balloon by the liquid filling structure 11 of the liquid filling component 1 enters the positioning channel 212, thereby increasing the fluid required for the expansion of the balloon body 22. After the isolation balloon 2 is filled, the balloon body 22 is a track-shaped body with two parallel planes and a cross section.

[0039] Reference Figures 4-6 ; the liquid filling component 1 comprises a liquid filling structure 11 and a fixing structure.

[0040] Reference Figures 5-6The liquid-filled structure 11 includes a cylindrical port body 111, a sealing structure and a connecting head 113, and a plugging head 114. The port body 111 has a cavity 1111 inside, and the first end of the port body 111 is exposed to the outside of the body; the sealing structure is used to seal the cavity 1111 inside the port body 111, and the sealing structure is located at the first end of the port body 111; the sealing structure can be set as a puncture film 1121 or a closed valve 1122 structure; the connecting head 113 and the plugging head 114 are both arranged at the second end of the port body 111, the connecting head 113 has a through cavity, the first end of the connecting head 113 is in communication with the cavity 1111 inside the port body 111, and the second end of the connecting head 113 is in communication with the inflation channel 211 of the connecting pipe 21 of the isolation balloon 2; the plugging head 114 is a solid sealing structure, which can also be a hollow structure with both ends closed. The arrangement of the plugging head 114 can avoid the entry of liquid into the positioning channel 212, and can also maintain the stability of the combination of the liquid-filled component 1 and the connecting pipe 21 after combination, avoid the formation of a gap between the port body 111 and the positioning channel 212 due to deflection, and the entry of liquid into the positioning channel 212. Further, it can further avoid the continuous irritation of the wound caused by movement, thereby causing the patient's pain to intensify; the connecting head 113 enters the inflation channel 211 to complete the combination of the connecting head 113 and the connecting pipe 21, and the plugging head 114 enters the positioning channel 212 to complete the combination of the plugging head 114 and the connecting pipe 21, and the connecting head 113 and the plugging head 114 are detachably connected with the connecting pipe 21. Through the detachable connection mode, a relatively long connecting pipe 21 can be pre-set, and the connecting pipe 21 is cut according to the patient's condition during the operation, so that the length is just connected with the liquid-filled component 1 and the liquid-filled component 1 can be embedded on the body surface. In this way, the problem of mismatching length of the connecting pipe 21 and the problem of mismatching length of the connecting pipe 21 can be avoided by using a fixed connection mode, and the above problems can be effectively solved by the detachable combination mode. In addition, the detachable connection mode can also ensure the positioning and adjustment of the position of the balloon body 22 by the positioning rod 23, and cannot be set or set complicated structure on the liquid-filled component 1 to ensure that the positioning rod 23 enters the position of the balloon body 22.

[0041] Reference Figures 4-5The fixed structure is used to fix the liquid-filled component 1 by being fixed to the skin surface, the fixed structure is connected to the outer side wall of the port body 111, is arranged at a position between the first end and the second end of the port body 111 and is fixed relative to the longitudinal axis of the port body 111, and the fixed structure divides the port body 111 into a first part 1112 exposed to the outside of the body and a second part 1113 embedded in the skin incision. The fixed structure is a fixed sheet 12 provided on the outer side wall of the port body 111, and the side of the fixed sheet 12 in contact with the skin is provided with an adhesive layer, which is fixed to the skin around the incision by means of adhesion or suturing. The fixed sheet 12 is an annular disc arranged to extend outward around the port body 111 by 360°, and the ring width of the annular disc ranges from 5 mm to 20 mm; the adhesive layer 121 is a 360-degree annular layer. In this way, 100% protection of the surgical incision can be ensured, and once the external bacteria interfere with the incision, the risk of infection caused by exposure of the wound can be avoided. Alternatively, a plurality of suture holes are arranged in an array on the fixed sheet 12, and the fixed structure is fixed through the suture holes. The edge array arrangement can better fix the fixed structure, and four suture holes 122 are usually arranged. It should be noted that the suture holes 122 can be arranged in 4-8. In a more preferred embodiment, a plurality of suture holes 122 are arranged on the outer edge of the fixed sheet 12 on the basis of the adhesive layer 121 arranged on the fixed sheet 12, and the suture holes 122 are arranged in an array on the edge of the fixed sheet 12. The edge array arrangement can better fix the fixed structure, and four suture holes 122 are usually arranged. It should be noted that the suture holes 122 can be arranged in 4-8. In use, the adhesive layer 121 is first attached to the skin around the incision, and then the suture is passed through the suture holes 122 to suture the fixed sheet 12 to the skin, further strengthening the fixation of the fixed structure; the combination of the fixed sheet 12 and the adhesive layer 121 can maximize the firmness of the fixed sheet 12 on the body surface, and can maximize the avoidance of the risk of separation of the adhesive layer 121 from the skin and contact of the wound with the environment due to accidental touch during wearing of the liquid-filled assembly by the patient, and can maximize the avoidance of wound infection.

[0042] It should be noted that the central axis of the port body 111 from the first end to the second end is the longitudinal axis of the port body 111, and the fixed sheet 12 is fixed relative to the longitudinal axis of the port body 111, which means that there is no displacement along the longitudinal axis, but if necessary, the fixed structure and the port body 111 can rotate along the longitudinal axis; such an arrangement mainly meets the needs of a certain degree of activity, and the rotating action can reduce the harm to the patient. Generally, the fixed sheet 12 is directly fixed to the port body 111 without displacement or position change. Because the connecting tube 21 is a soft and elastic connecting tube 21, the shape change of the connecting tube 21 can meet the needs of the patient's activity.

[0043] A more preferred embodiment is that the outer diameter of the port body 111 is greater than or equal to the outer diameter of the connecting tube 21. The outer diameter of the port body 111 is set to 5 mm, but it can also be any other outer diameter between 5 and 15 mm. This outer diameter corresponds very well to the size of the puncture sheath. The puncture incision constructed by the puncture sheath can be directly used for the embedding of the port body 111, so that the entire operation does not require further enlarging of the skin incision. Compared with the prior art, the size of the skin incision is greatly reduced. Moreover, because of the embedding method, after use, it is only necessary to withdraw the liquid in the balloon body 22, separate the fixation piece 12 from the skin, and then withdraw the isolation balloon from the body. Then the skin incision is sutured. The whole process only involves one skin incision and suturing operation, which is very small for the patient.

[0044] A more preferred embodiment is that the length of the first part 1112 of the harbor body 111 is 0 mm or 5 mm. Specifically, it is set to not exceed 10 mm, which makes the operation of the harbor body 111 more convenient.

[0045] The adhesive layer 121 is specifically designed to be made of bio-adhesive. Before use, a protective film (not shown in the attached diagram) is applied to the adhesive layer 121. During use, the protective film is removed from the adhesive layer 121, allowing it to contact the skin around the incision. The 360-degree fixation structure and the adhesive layer 121 effectively isolate the skin incision from the external environment, preventing infection.

[0046] The fixation piece 12 can be a rigid piece, but it is preferred to use a soft piece. Medical materials can be selected. The reason for using a soft piece is that it can meet the patient's activity needs and has a high degree of conformity with the skin, which can improve the patient's comfort during use.

[0047] It should be noted that the filling component 1 and the connecting tube 21 are difficult to separate once combined. The setting method can be the combination of the existing infusion port filling structure and the conduit. Alternatively, the connector 113 and the plugging head 114 can both be set as pagoda heads to achieve the purpose of making them difficult to separate after combination. The pagoda head is a common structure, which is not shown in the attached figure, but it does not affect the understanding of the solution.

[0048] A more preferred embodiment is, referring to Figure 4 When the closed structure is set as puncture membrane 1121, the thickness of puncture membrane 1121 is set to 3mm. Of course, it can also be any thickness between 1-5mm. This thickness setting can meet the needs of repeated punctures and also meet the sealing requirements after the puncture membrane 1121 comes into contact with the side wall of the port body 111. The sealing requirements are achieved by using a relatively thick membrane.

[0049] Or, refer to Figure 7; the closed structure is a closed valve 1122, which is a kind of elastic valve structure that can be in a normally open state when a syringe is inserted into it; when the syringe is not inserted, it is a kind of closed valve 1122, which prevents liquid from flowing out. This method can meet the requirements of liquid filling and discharging. The first part 1112 of the port body 111 is provided as a syringe connector for the syringe to be inserted into the syringe connector. When the syringe is connected to the syringe connector, the closed valve 1122 becomes a normally open valve, so that the syringe connector can be directly used for liquid filling and discharging after the syringe is connected to the syringe connector. When the syringe is withdrawn, the closed valve 1122 prevents liquid from flowing out. The closed valve 1122 can also be provided as any kind of common one-way valve structure on the market.

[0050] The whole process of using the isolation device is as follows: the implantation process of the present application is similar to CN116440428A-a kind of implantable tissue isolation device that can be repeatedly charged and discharged in vivo, first, puncture is performed through a small incision on the body surface using a puncture device, a channel from the body surface to the tissue to be isolated is constructed and a guide sheath is sent in, then the support rod is extended into the positioning channel 212, and then the isolation balloon 2 is sent into the space between the radiotherapy tissue and the tissue to be isolated under the guidance of the support rod, after the guide sheath is removed, the balloon is inflated by inflating the channel 211 to inflate the balloon body 22 with special liquid, then the position and angle of the isolation balloon 2 are adjusted to satisfaction by adjusting the support rod, then the support rod is removed, then the liquid in the balloon is pumped out or the connecting pipe 21 is clamped by hand, the length of the connecting pipe 21 is trimmed, finally, the liquid filling component 1 and the connecting pipe 21 are combined, and the connecting head 113 is inserted into the inflation channel 211, and the sealing head 114 is inserted into the positioning channel 212; after combination, the second part 1113 of the port body 111 is embedded in the skin incision, the protective film on the adhesive layer 121 of the fixing sheet 12 is torn off, the adhesive layer is tightly attached to the skin around the incision, and the fixing structure is fixed to the skin around the incision, and the skin incision is sealed, and the isolation device is set. When radiotherapy is needed, puncture the puncture film 1121 with a puncture needle, connect the puncture needle to a syringe, and inject liquid into the balloon body 22 through the syringe to isolate the tissue to be irradiated from the tissue to be protected; after the balloon body 22 is inflated, the puncture needle is separated from the puncture film 1121; after a single radiotherapy is completed, the puncture needle is inserted into the closed structure combination, and the liquid in the balloon body 22 is pumped out. Repeat the above operation for the next radiotherapy until the 1-2 week large fraction radiotherapy course is completed, then empty the balloon completely, then separate the adhesive layer 121 from the skin and remove the suture from the suture hole 122, separate the fixing sheet 12 from the skin, and finally pull out the liquid filling structure 11 together with the isolation balloon 2 from the body. The above operation is only a general operation process, and for some tissue isolation balloons 2 with loose space, it is not necessary to charge and discharge every time, and it can be kept inflated all the time. When the closed structure is a closed valve 1122, only the syringe is inserted into the syringe joint of the first part 1112 of the port body 111 to perform the liquid charging and discharging operation, and the other operations are the same.

[0051] Example 2

[0052] Reference Figures 8-9 A kind of endoscopic implantation of liquid filling structure 11 is embedded in the skin tissue isolation device, which is different from example 1 in that the soft connecting pipe 21 only has one inflation channel 211, and the second end of the port body 111 only has a connecting head 113, without positioning channel 212 and corresponding sealing head 114, and the other settings are the same.

[0053] The difference is that the position and angle of the capsule 22 are not positioned by using the support rod, but the isolation balloon 2 is introduced into the body through a small incision in the body surface under the direct vision of the endoscope, the capsule 22 is placed at the position to be isolated, and then inflated and fixed, and then the soft connecting tube 21 is cut to the appropriate length and connected with the liquid filling part 1, and the other operation steps are the same as those of Example 1.

[0054] The technical solutions in the embodiments of the present application are clearly and completely described above through specific specific embodiments. Obviously, the described embodiments are only some of the embodiments of the present application, not all the embodiments. Those skilled in the art can easily understand other advantages and effects of the present application from the content disclosed in the present application. The present application can also be implemented or applied by other different specific embodiments. In the case of no conflict, the following embodiments and features in the embodiments can be combined with each other. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor belong to the protection scope of the present application.

Claims

1. A liquid-filled component embedded in the skin surface, characterized in that, It includes Liquid-filled structure, including The harbor body has an internal cavity, with its first end exposed to the outside. A closed structure, located at the first end of the port body, is used to seal the cavity inside the port body and is configured as a puncture membrane or a sealing valve structure that can be repeatedly punctured. A connector is located at the second end of the harbor body. The connector has a through cavity. The first end of the connector communicates with the cavity inside the harbor body, and the second end of the connector communicates with the soft connecting tube of the isolation balloon. The connector and the connecting tube are detachably connected. A fixing structure is used to fix the fluid-filled component by fixing it to the skin surface. The fixing structure is connected to the outer wall of the port body, is located between the first end and the second end of the port body and is fixed relative to the longitudinal axis of the port body. The fixing structure divides the port body into a first part exposed outside the body and a second part embedded in the skin incision.

2. A tissue isolation device with a fluid-filled component embedded in the skin, comprising, An isolation balloon, comprising an interconnected balloon body and a flexible connecting tube, characterized in that, Also includes Liquid-filled structure, including The harbor body has an internal cavity, with its first end exposed to the outside. A closed structure, located at the first end of the port body, is used to seal the cavity inside the port body and is configured as a puncture membrane or a sealing valve structure that can be repeatedly punctured. A connector is located at the second end of the harbor body. The connector has a through cavity. The first end of the connector communicates with the cavity inside the harbor body. The second end of the connector communicates with the connecting tube of the isolation balloon. The connector and the connecting tube are detachably connected. The fixation structure is fixed to the patient's skin surface and connected to the outer wall of the aorta. It is located between the first end and the second end of the aorta and fixed relative to the longitudinal axis of the aorta. The fixation structure divides the aorta into a first part exposed outside the body and a second part embedded in the skin incision.

3. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 2, characterized in that, The fixation structure is a fixation plate installed on the outer wall of the harbor body. The side of the fixation plate that contacts the skin is provided with an adhesive layer, and / or a suture hole is provided on the fixation plate.

4. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 3, characterized in that, The fixing plate is an annular disc extending outward around the harbor body in a 360° direction, and the adhesive layer is an annular layer in a 360° direction.

5. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 3, characterized in that, The fixing piece has a plurality of suture holes through its edge, and the suture holes are evenly arrayed along the edge of the fixing piece.

6. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 4, characterized in that, The ring width of the annular disk ranges from 5 to 20 mm.

7. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 2, characterized in that, The connecting pipe is provided with a filling channel and a positioning channel. The filling structure also includes a sealing plug, which is located at the second end of the port body and parallel to the connecting head. The sealing plug is a solid structure or a hollow structure that is closed at both ends. The connector extends into the charging channel, and the sealing head extends into the positioning channel.

8. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 3, characterized in that, The harbor body is cylindrical; the outer diameter of the harbor body ranges from 5 to 15 mm.

9. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 8, characterized in that, The outer diameter of the harbor body is greater than or equal to the outer diameter of the connecting pipe.

10. A tissue isolation device with a fluid-filled component embedded in the skin according to claim 8, characterized in that, The fixing plate is set perpendicular to the longitudinal axis of the harbor body, and the length of the first part of the harbor body is less than or equal to 10mm.

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