Implantable tissue isolation device capable of being repeatedly filled and drained in body

Abstract

An implantable tissue isolation device capable of being repeatedly filled and drained in the body, which is generally used in the field of tumor radiotherapy. The implantable tissue isolation device comprises: an isolation balloon, which is used to isolate normal tissue from tissue receiving radiotherapy and comprises, after being filled, two contact surfaces, namely, a first contact surface that is in contact with the normal tissue to be isolated, and a second contact surface that is in contact with the tissue receiving radiotherapy, a distance between the first contact surface and the second contact surface being not less than a distance required for the radiation dose to drop to a tolerable range of the normal tissue; a filling connection structure, which is subcutaneously implanted and is connected to a filling structure outside the body to fill or drain the isolation balloon; and a flexible connection tube, which is connected to the isolation balloon and the filling connection structure. The isolation of a defined distance can be accurately achieved through arrangement of the two contact surfaces, and long-term carrying and repeated use of the isolation device can be achieved by means of the subcutaneously implanted filling connection structure, thereby ensuring that the entire isolation device can be repeatedly filled and drained in the body and can play an isolation role.

Description

An implantable tissue isolation device that can be repeatedly charged and discharged in the body Technical Field

[0001] The present invention belongs to the field of medical device technology, and in particular relates to a tissue protection device used during radiotherapy, specifically an implantable tissue isolation device that can be repeatedly charged and discharged in the body, and is generally used in the field of tumor radiotherapy. Background Art

[0002] Radiation therapy is a localized treatment method for tumors that utilizes radiation. Radiation primarily includes high-energy X-rays, electron beams, and proton beams generated by accelerators. Approximately 70% of cancer patients require radiation therapy during treatment, and approximately 40% of cancers are curable with radiation therapy. The role and status of radiation therapy in tumor treatment are growing increasingly prominent, making it a primary treatment modality for malignant tumors.

[0003] The biggest challenge facing tumor radiotherapy is effectively protecting adjacent normal organs and tissues, especially those that are sensitive to radiation, such as the intestines, glands, and lymph nodes. While radiation kills tumor cells, it inevitably damages normal tissues, potentially leading to various serious and irreversible complications.

[0004] The prior art discloses a CN202110281992-A prostate and rectum isolation device; it discloses an ellipsoidal isolation device, and controls the inflation or liquid filling by setting a spring-type control valve. However, tumor radiotherapy is a long-term treatment, not a single treatment; a course of radiotherapy usually includes 20-40 irradiation treatments, once a day (about 10-20 minutes), and a course of treatment needs to last 4-8 weeks. This technology does not take into account the radiotherapy cycle problem, and the inflation / liquid valve design is located outside the body, which cannot be carried by the patient for a long time. The feasibility of conversion and use in clinical practice is low; in addition, the ellipsoidal setting easily causes positional movement during tissue isolation.

[0005] In recent years, European and American countries have used puncture technology to inject biodegradable hydrogels or hyaluronic acid between the rectum and prostate for rectal isolation. Prostate radiotherapy treatments last only 10-20 minutes each time, requiring very little daily isolation time. However, after injection, the hydrogel or hyaluronic acid remains stable in the body for 3-6 months or even longer. During this period, the injected isolation hydrogel or hyaluronic acid exerts continuous pressure on the intestines, posing a risk of intestinal perforation and constipation. Furthermore, even after the 1-2 month course of treatment, this pressure and risk persist for a long time until it degrades. The persistent presence of the hydrogel or hyaluronic acid can easily lead to complications.

[0006] In response to the above technical problems, the present invention proposes an implantable tissue isolation device that can be repeatedly inflated and discharged in the body.

[0007] Summary of the Invention

[0008] Distance protection is still the most important and most effective means of radiation protection. Modern radiotherapy equipment is already very accurate. Isolating the distance between normal tissue and tumor tissue by 1-2 cm can significantly reduce the radiation dose and greatly reduce the risk of complications. By setting an isolation balloon with a preset shape, an effective and stable isolation distance can be formed between normal tissue and tissue receiving radiotherapy; through the cooperation of a soft connecting tube, an inflatable connecting structure implanted in the subcutaneous tissue and an isolation balloon, the purpose of isolation during daily radiotherapy and no isolation when not undergoing radiotherapy can be achieved. It can not only be used for rectal isolation during radiotherapy of prostate cancer, but also for isolation of adjacent normal tissues during radiotherapy of a variety of other tumors. The specific plan is:

[0009] An implantable tissue isolation device that can be repeatedly inflated and discharged in the body, comprising:

[0010] The isolation balloon is always placed between normal tissue and tissue receiving radiotherapy during a radiotherapy course; after being inflated, it is used to isolate normal tissue from tissue receiving radiotherapy;

[0011] After being inflated, the device comprises two contact surfaces, namely a first contact surface and a second contact surface; the first contact surface contacts the tissue to be isolated, and the second contact surface contacts the tissue to be radiotherapy;

[0012] The minimum distance between the first contact surface and the second contact surface is not less than the distance at which the radiation dose drops to a dose that normal tissue can tolerate.

[0013] During radiotherapy, the isolation balloon is inflated to isolate normal tissue from the treated tissue. During non-radiotherapy periods, the isolation balloon is deflated to maintain the normal physiological state of both tissues and reduce damage from continued compression. Because a course of radiotherapy can be quite long, the isolation balloon is periodically inflated and deflated before and after each treatment.

[0014] Furthermore, the first contact surface and the second contact surface are the same plane; the first contact surface and the second contact surface are parallel planes; the parallel planes can effectively maintain a stable distance. Alternatively, the first contact surface and the second contact surface are curved surfaces with a lower center and higher sides;

[0015] The device also includes an inflation connection structure for connecting the isolation balloon with an external inflation structure; the inflation connection structure is implanted in the subcutaneous tissue, and the inflation connection structure is connected to the inflation structure to realize inflation and emptying of the isolation balloon.

[0016] When used for the first time, first establish an isolation balloon entry channel; place the isolation balloon between normal tissue and tissue receiving radiotherapy, and then bury the inflated connection structure connected to it in the subcutaneous tissue; before each irradiation treatment, first disinfect the skin on the surface of the inflated connection structure, and then use the filling structure to penetrate the skin and repeatedly pierce the sealing structure to connect the filling structure with the inflated connection structure; thereby connecting the isolation balloon and the filling structure, and then push the filling material in the filling structure into the isolation balloon to inflate the isolation balloon to a set shape to play an isolation role; when the treatment is over, the filling material is extracted from the isolation balloon to empty the isolation balloon; wait for the next treatment and repeat the above operation until a course of radiotherapy is completely completed; by putting the isolation balloon in a contracted negative pressure state, use a recovery sheath to cover the isolation balloon, and withdraw the isolation balloon from the body by withdrawing the recovery sheath, or directly withdraw the contracted isolation balloon. This setup allows for repeated inflation and deflation of the isolation balloon within the body, simplifying the entire procedure. The implantable design effectively minimizes the impact of the device on the patient's daily life, reduces discomfort, and reduces the risk of infection. In addition to puncture, initial access for the isolation balloon can be established through laparoscopy or a small incision. After use, the isolation balloon is easily removed, leaving no residue in the body.

[0017] Furthermore, a soft connecting tube is provided between the inflation connecting structure and the isolation balloon, and an inflation pipeline is provided in the soft connecting tube; the material thereof is a medical polymer material; this arrangement can ensure the safety of the connecting tube when it is placed in the body for a long time, and avoid damage to the tissue by the connecting tube.

[0018] Furthermore, by configuring the inflatable connection structure to be an embodiment with an implantation seat, and correspondingly configuring a connection with the soft connection tube, a repetitive puncture sealing structure that allows for repeated puncture is provided on the implantation seat.

[0019] Furthermore, the first and second contact surfaces are each provided with a drug-loaded coating, wherein the first and second contact surfaces carry different drugs, the first contact surface does not carry chemotherapy drugs for treating tumors, and the second contact surface does not carry radiation protectants. Anesthetic drugs and analgesics can be provided on both the first and second contact surfaces.

[0020] Furthermore, for superficial tissue, the isolation balloon is placed between normal tissue and the tissue receiving radiotherapy using ultrasound or CT guidance through a puncture method. For deep tissue, the isolation balloon is placed between normal tissue and the tissue receiving radiotherapy through laparoscopic surgery. After the isolation balloon is implanted, the inflated connecting structure is implanted subcutaneously.

[0021] Beneficial effects of the present invention:

[0022] 1. The inflation connection structure is implanted and fixed subcutaneously, achieving the following: 1. The entire device is fully implantable and can be carried long-term in the body; 2. The isolation balloon can be repeatedly inflated and deflated throughout the radiotherapy cycle, with inflation occurring only during radiotherapy and deflation occurring afterward, avoiding continuous tissue compression and damage caused by continued isolation. The balloon is inflated before treatment and deflated afterward, with only 10-20 minutes of inflation per day, minimizing tissue compression. Furthermore, the implantable device does not affect the patient's daily life (bathing), reducing the risk of infection.

[0023] 2. The purpose of establishing a stable isolation distance is achieved by setting two contact surfaces with a minimum distance after charging; an effective distance can be established once charging without the need for cumbersome operation procedures.

[0024] 3. Whether it is for the isolation of superficial tissue or deep tissue, it is implanted through a minimally invasive small incision surgical approach under puncture or laparoscopy; the entire implantation process does not require open surgery; the entire isolation balloon implantation method is fast and minimally invasive.

[0025] 4. After a course of radiotherapy, the isolation balloon can be quickly removed by emptying the substance in the isolation balloon and preferably forming negative pressure, leaving no residue in the body and completely relieving tissue compression and foreign body sensation.

[0026] 5. Accurately placing radioprotective agents and sustained-release local anesthetics on the first contact surface can effectively relieve pain and reduce the interference of radiotherapy on normal tissues. Accurately placing chemotherapy drugs and sustained-release local anesthetics on the second contact surface can effectively relieve pain in tumor tissues and conduct targeted chemotherapy treatment, thereby improving the treatment effect through dual treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG1 is a schematic diagram of the overall structure of an embodiment of the present invention in which a soft connecting tube is arranged on the side of an implant seat and perpendicular to the implant seat;

[0028] FIG2 is a schematic diagram of the overall structure of an embodiment of the present invention in which the soft connecting tube is arranged on the side of the implant seat and perpendicular to the implant seat;

[0029] FIG3 is a schematic diagram of the structure of the isolation balloon and the soft connecting tube with the support and positioning structure without the implant seat portion of the present invention;

[0030] FIG4 is a schematic diagram of a longitudinal cross-sectional view of the charging and connecting structure of the present invention;

[0031] FIG5 is a schematic longitudinal cross-sectional view of the inflatable connecting structure with a sealing cap according to the present invention;

[0032] FIG6 is a schematic diagram of a transverse cross-sectional structure of a flexible connecting pipe including an inflation pipe and a positioning pipe according to the present invention;

[0033] FIG7 is a schematic diagram of the structure of the isolation balloon and its internal soft connecting tube, with a plane bottom as a cross-section;

[0034] FIG8 is a schematic structural diagram of an implant seat and a portion of the soft connecting tube connected thereto in an embodiment of the present invention in which a soft connecting tube is provided below the implant seat;

[0035] 9 is a schematic structural diagram of the bottom surface of the implant seat according to an embodiment of the present invention, in which a soft connecting tube is provided below the implant seat;

[0036] FIG10 is a schematic structural diagram of a specific implementation of the present invention in which an isolation balloon is placed between deep tumor tissue and normal tissue; wherein a soft connecting tube is placed below the implant seat;

[0037] FIG11 is a schematic structural diagram of a specific embodiment of the present invention wherein the isolation balloon is disposed between the prostate and the rectum; wherein the soft connecting tube is disposed on the side of the implant seat and perpendicular to the bottom of the implant seat;

[0038] FIG12-A is a cross-sectional structural diagram of the isolation balloon of the present invention, with the front view as the cross-section;

[0039] FIG12-B is a schematic cross-sectional view of the isolation balloon of the present invention, taken along the upper surface;

[0040] FIG12-C is a schematic cross-sectional view of the isolation balloon of the present invention, with the right side as the cross-sectional view.

[0041] Explanation of main reference numerals 1. Isolation balloon; 11. First contact surface; 12. Second contact surface; 13. Extension tube; 2. Soft connecting tube; 21. Inflation pipeline; 211. Inflation through hole; 22. Positioning pipeline; 221. Sealing cap; 222. Positioning port; 3. Inflation connection structure; 4. Support and positioning structure; 51. Implant seat; 52. Connecting cavity; 53. Repeated puncture sealing structure; 54. Protective baffle; 541. Connecting hole; 55. Connecting port; 56. Suture loop. DETAILED DESCRIPTION

[0042] Example 1

[0043] Referring to Figures 1 and 2; an implantable tissue isolation device that can be repeatedly charged and discharged in the body, comprising:

[0044] The isolation balloon 1 is always placed between the normal tissue and the tissue receiving radiotherapy during a radiotherapy course and is removed from the body after the radiotherapy course. When placed in the body, it is used to isolate the normal tissue from the tissue receiving radiotherapy after being inflated; and is used to maintain the normal physiological state of the normal tissue and the tissue receiving radiotherapy after being emptied.

[0045] When inflated, it comprises two contact surfaces, namely a first contact surface 11 and a second contact surface 12; the first contact surface 11 contacts the tissue to be isolated, and the second contact surface 12 contacts the tissue to be radiotherapy;

[0046] The distance between the first contact surface 11 and the second contact surface 12 can be preset when the balloon is manufactured and can be adjusted as needed; the minimum distance between the first contact surface 11 and the second contact surface 12 is not less than the distance at which the radiation dose drops to a range that can be tolerated by normal tissue;

[0047] A more preferred approach is that the minimum distance between the first contact surface 11 and the second contact surface 12 is in the range of 1-2 cm; this range can basically meet the needs of normal tissue isolation in most current tumor radiotherapy processes, and the specific distance can also be preset according to the sensitivity of the tissue to radiation.

[0048] In a more preferred embodiment, the distance setting further includes, and / or the maximum distance between the first contact surface 11 and the second contact surface 12 is not greater than the maximum distance that the stretched tissue can withstand.

[0049] More specifically, after inflation, the minimum distance between the first contact surface 11 and the second contact surface 12 is no less than the distance required for the radiation dose to drop to a level within the tolerance range of normal tissue. The maximum distance between the first contact surface 11 and the second contact surface 12 is no greater than the maximum distance that the stretched tissue can withstand. If these two distances conflict, the maximum distance, whichever is greater, prevails. This configuration reduces the amount of radiotherapy radiation while avoiding irreversible damage to the physiological state of tissue.

[0050] During radiotherapy, the isolation balloon 1 is inflated to isolate normal tissue from the tissue receiving radiotherapy; during non-radiotherapy, the isolation balloon 1 is emptied to maintain the normal physiological state of the normal tissue and the tissue receiving radiotherapy, and reduce the damage to the tissue caused by continuous pressure.

[0051] This configuration ensures that the balloon is inflated during radiotherapy and acts as an isolation barrier, while emptying during non-radiotherapy procedures to maintain normal physiological conditions between tissues. The first and second contact surfaces 11, 12 ensure a safe isolation distance. Repeated inflation and deflation are crucial when the tumor is located in a confined area or when surrounding tissue cannot tolerate prolonged compression. The balloon can be inflated via transdermal puncture before each treatment and deflated immediately afterward, minimizing compression and damage to normal tissue and reducing tissue damage during radiotherapy.

[0052] In a more preferred embodiment, the first contact surface 11 and the second contact surface 12 are the same plane, and the projections of the first contact surface 11 and the second contact surface 12 on the horizontal plane overlap; the completely identical setting can ensure the stability of the overall setting state; in a more preferred embodiment, the first contact surface 11 and the second contact surface 12 are two parallel planes; the parallel planes can effectively maintain a stable distance, and the overall distance is consistent. In a more preferred embodiment, the peripheral areas of the first contact surface 11 and the second contact surface 12 corresponding to the isolation balloon 1 are higher than the first contact surface 11 and the second contact surface 12; this setting can ensure the formation of a structure with a low middle and high sides, avoiding the position movement of the tissue during the process. Alternatively, the peripheral areas of the first contact surface 11 and the second contact surface 12 corresponding to the isolation balloon 1 are lower than the first contact surface 11 and the second contact surface 12, and an arc connection is achieved at the periphery of the first contact surface 11 and the second contact surface 12; this setting can ensure that unnecessary isolation pressure is not caused to the surrounding tissues, and better tissue protection.

[0053] A more preferred embodiment is, referring to Figure 12-A, Figure 12-B, and Figure 12-C; the first contact surface 11 and the second contact surface 12 are set to be elliptical or notch-shaped, and the top view shape of the entire isolation balloon 1 is notch-shaped; the left and right side views are notch-shaped; and the front and back view shapes are also notch-shaped.

[0054] Alternatively, the shapes of the first contact surface 11 and the second contact surface 12 are configured as follows: the first contact surface 11 and the second contact surface 12 are curved surfaces with a lower middle and higher sides; this configuration can cause the tissue to be in a raised state, thereby preventing the tissue from shifting.

[0055] A more preferred embodiment is that the isolation balloon 1 is a balloon of a preset shape, and after it is inflated, the distance between the first contact surface 11 and the second contact surface 12 is in the range of 1-2 cm; this distance setting can basically meet the requirement of reducing the radiation dose to a level that normal tissue can tolerate; and will not cause traction damage to the tissue due to the isolation distance being too large.

[0056] In a more preferred embodiment, the material of the balloon wall corresponding to the first contact surface 11 and the second contact surface 12 is different from the material of the other parts of the isolation balloon 1. The balloon wall corresponding to the first contact surface 11 and the second contact surface 12 is made of an inelastic material, or the entire isolation balloon 1 is made of an inelastic soft material. This method easily forms a planar shape and maintains distance effectiveness. Preferably, the isolation balloon 1 is integrally formed in vitro, blown in a mold; this manufacturing method ensures the simplicity of the isolation balloon 1 manufacturing method.

[0057] A more preferred embodiment is to provide isolation balloons 1 of different models, and to provide soft connecting tubes 2 of different lengths according to the needs of different areas, and to select different models according to the conditions of the tumor and the tissue to be isolated.

[0058] A more preferred embodiment is that the device further comprises: an inflation connection structure 3; used to connect the isolation balloon 1 with an external filling structure; the inflation connection structure 3 is implanted and arranged subcutaneously, and the inflation connection structure 3 is connected to the filling structure to realize the inflation and emptying of the isolation balloon 1. Before a radiotherapy session, the inflation connection structure 3 is connected to the filling structure to complete the inflation of the isolation balloon 1 and maintain the inflation state. After a radiotherapy session is completed, the inflation connection structure 3 is connected to the filling structure to complete the emptying of the isolation balloon 1 and maintain it in its original position. Optionally, during a treatment session, the filling structure may not be removed, and may remain connected to the inflation connection structure 3 until the treatment is completed and the balloon is emptied, which can reduce the impact of repeated punctures on the patient and on repeated punctures of the sealing structure 53.

[0059] By implanting the charging connection structure 3 subcutaneously, the problem of not needing to connect the charging structure is solved. The isolation device is completely located in the patient's body and can be carried in the body for a long time without affecting the patient's life.

[0060] The device also includes a soft connecting tube 2 for connecting the inflation connection structure 3 with the isolation balloon 1, and the first end of the soft connecting tube 2 is the end that first enters the body; the first end of the soft connecting tube 2 is entirely or partially arranged in the isolation balloon 1; preferably, the first end of the isolation balloon 1 is the end that first enters the body; the first end of the soft connecting tube 2 extends from the first end of the isolation balloon 1; referring to Figure 7, an inflation through hole 211 connected to the isolation balloon 1 is provided on the soft connecting tube 2; or, extension tubes 13 are provided at both ends of the isolation balloon 1, and the extension tubes 13 are sealed and connected to the soft connecting tube 2, and the sealing state is biological glue adhesion.

[0061] The soft connecting tube 2 is made of medical polymer materials; among which medical silicone tube is preferred, or the material of the soft connecting tube 2 is polyetheramide block copolymer (Pebax), polytetrafluoroethylene (PTFE), polyamide material (PA), polyurethane (PU); this setting can ensure that the soft connecting tube 2 is placed in the body for a long time, and will not cause damage to the body tissue due to the patient's activities, and has high safety.

[0062] Note: The filling structure typically includes a non-invasive puncture needle, the tail end of which can be connected to a manual syringe or a filling pump, or other filling structure that can be connected to the filling connection structure 3. The filling substance is gas or liquid, and preferably a liquid, specifically a mixture of physiological saline and contrast agent.

[0063] When used for the first time, first establish an entry channel for the isolation balloon 1; place the isolation balloon 1 between the normal tissue and the tissue receiving radiotherapy, and then bury the inflatable connecting structure 3 connected to it in the subcutaneous tissue; before each irradiation treatment, first disinfect the skin on the surface of the inflatable connecting structure 3, and then use the filling structure to penetrate the skin and repeatedly pierce the sealing structure 53 to connect the filling structure with the inflatable connecting structure 3; thereby connecting the isolation balloon 1 and the filling structure, and then push the filling material in the filling structure into the isolation balloon 1 to inflate the isolation balloon 1 to the set shape to play an isolation role; when the treatment is over, the filling material is extracted from the isolation balloon 1 to empty the isolation balloon 1; wait for the next treatment and repeat the above operation until a course of radiotherapy is completely completed; by putting the isolation balloon 1 in a contracted state, use the recovery sheath to cover the isolation balloon 1, and withdraw the isolation balloon 1 from the body by withdrawing the recovery sheath, or directly withdraw the contracted isolation balloon 1. This setup allows for repeated inflation and deflation of the isolation balloon 1 within the body, simplifying the entire operation. The implantable design effectively minimizes the impact of the device on the patient's daily life, reduces discomfort, and reduces the risk of infection. In addition to puncture, initial access to the isolation balloon 1 can be established through laparoscopy or a small incision. After use, the isolation balloon 1 is easily removed, leaving no residue in the body.

[0064] In a more preferred embodiment, referring to Figures 2 and 3 , the charging connection structure 3 includes an implant seat 51 with a connecting cavity 52. ​​A repetitive puncture sealing structure 53 is fixedly disposed above the implant seat 51, capable of repeated puncture without external communication. A soft connecting tube 2 is disposed perpendicular to the bottom of the implant seat 51, the lumen of which communicates with the connecting cavity 52. ​​The charging structure includes a non-invasive puncture needle, which punctures the repetitive puncture sealing structure 53 to communicate with the connecting cavity 52. ​​This method allows for post-implant charging.

[0065] A more preferred embodiment, referring to Figures 8 and 9, is provided with various anti-puncture methods to prevent the non-invasive puncture needle from puncturing the soft connecting tube 2. The first anti-puncture method is to provide a protective baffle 54 with a connecting hole 541 at the connection point between the soft connecting tube 2 and the implant seat 51. The aperture of the connecting hole 541 is smaller than the outer diameter of the non-invasive puncture needle. This setting can prevent the non-invasive puncture needle from entering the soft connecting tube 2, thereby avoiding puncture and damage to the soft connecting tube 2.

[0066] The second anti-puncture method is to place the soft connecting tube 2 perpendicular to the bottom of the implant seat 51 and not overlap with the vertical projection of the repeated puncture sealing structure 53 on the bottom of the implant seat 51; shrink the repeated puncture sealing structure 53 and place it on one side of the implant seat 51, and place the soft connecting tube 2 on the other side of the bottom of the corresponding implant seat 51 without overlapping.

[0067] The third anti-puncture method is, with reference to Figures 4 and 5, to provide a communication port 55 in the communication cavity 52 of the implant seat 51 at an angle to the longitudinal direction of the communication cavity 52; the communication port 55 opens toward the side of the implant seat 51, and the communication port 55 is connected to the lumen of the soft connecting tube 2 provided on the side of the implant seat 51; this method effectively prevents the soft connecting tube 2 from contacting the non-invasive puncture needle, thereby minimizing the risk of puncturing the soft connecting tube 2. A more preferred embodiment is that the communication port 55 faces the longitudinal direction of the vertical communication cavity 52, and the communication port 55 is provided on the side of the implant seat 51 and perpendicular to the bottom of the implant seat 51. This arrangement can ensure safety.

[0068] The fourth anti-puncture method is: the length of the non-invasive puncture needle is greater than the thickness of the repeated puncture sealing structure 53, but less than the sum of the heights of the repeated puncture sealing structure 53 and the connecting cavity 52. ​​This method also effectively prevents the non-invasive puncture needle from entering the soft connecting tube 2.

[0069] In a more preferred embodiment, the soft connecting tube 2 is smoothly arranged throughout the entire entry path. This arrangement can effectively avoid blockage of the lumen of the soft connecting tube 2 due to bending.

[0070] A more preferred embodiment is, referring to FIG8 , a suture ring 56 is further provided on the implant seat 51 for fixing it to the subcutaneous tissue. By providing the suture ring 56 , effective fixation of the implant seat 51 can be achieved.

[0071] A more preferred embodiment is that, except for the repeatedly piercing sealing structure 53 which is the pierceable part, the rest of the implant seat 51 is made of medical hard material. This arrangement can facilitate fixation and ensure the safety of the implant seat 51, preventing the implant seat 51 from being pierced.

[0072] In a more preferred embodiment, the repeatedly punctured sealing structure 53 is made of rubber material with a thickness of not less than 1 mm; this arrangement can ensure that the repeatedly punctured sealing structure 53 will not have any leakage points when repeatedly punctured by the non-invasive puncture needle.

[0073] A more preferred embodiment is one in which the isolation balloon 1 is coated with a drug-loaded coating, wherein the first contact surface 11 carries a radioprotectant and / or a sustained-release local anesthetic, but not a chemotherapy drug; and the second contact surface 12 carries a chemotherapy drug and / or a sustained-release local anesthetic, but not a radioprotectant. The local anesthetic effectively alleviates the localized pain and pulling sensation caused by tissue expansion, while the sustained-release chemotherapy drug on the second contact surface 12 ensures simultaneous chemotherapy treatment throughout the entire radiotherapy cycle, resulting in a more significant dual-treatment effect.

[0074] The isolation balloon 1 is used to isolate the tissue receiving radiotherapy from normal tissue. When used to isolate deep tissue, refer to Figure 10; the device can be implanted via a laparoscopic surgery route.

[0075] When the isolation balloon 1 is used to isolate superficial tissue, referring to FIG11 , the device can be implanted through a puncture path under the guidance of CT or B-ultrasound.

[0076] Example 2

[0077] The technical solution of Example 1 is applied to the isolation of superficial tissue, specifically prostate tumor tissue and normal rectal tissue; referring to Figures 1, 3, 4, 5, and 6, a positioning pipe 22 is provided on the soft connecting pipe 2, and a supporting positioning structure 4 is provided within the positioning pipe 22; the supporting positioning structure 4 is a hard support rod. The specific implementation method is as follows:

[0078] In addition to the inflating pipeline 21 for inflating the isolation balloon 1, the soft connecting tube 2 also includes a positioning pipeline 22. The positioning pipeline 22 is provided with a support and positioning structure 4 for adjusting the position and angle of the isolation balloon 1.

[0079] 4 , a positioning port 222 corresponding to the positioning pipeline 22 is provided on the charging connection structure 3 . The supporting positioning structure 4 is introduced into the entire positioning pipeline 22 through the positioning port 222 on the charging connection structure 3 .

[0080] When the support and positioning structure 4 is disposed in the positioning pipeline 22 , the support and positioning structure 4 drives the isolation balloon 1 to move or rotate in the body to achieve positioning of the isolation balloon 1 .

[0081] More specifically, when the isolation balloon 1 enters the body and is placed between normal tissue and tissue receiving radiotherapy, the support positioning structure 4 is placed in the positioning conduit 22, and the position and angle of the support positioning structure 4 are adjusted in vitro to adjust the position and angle of the isolation balloon 1.

[0082] In a more preferred embodiment, the charging pipeline 21 and the positioning pipeline 22 are arranged in parallel; the charging pipeline 21 and the positioning pipeline 22 are integrated into a unified soft connecting pipe 2. The parallel arrangement can reduce the difficulty of setting up and running the pipelines.

[0083] In a more preferred embodiment, the spacer balloon 1 is attached to the soft connecting tube 2, and only an inflation hole 211 is provided on the side wall of the inflation line to communicate with the spacer balloon 1. The inflation hole 211 enables the spacer balloon 1 to be inflated through the inflation line 21 of the soft connecting tube 2.

[0084] In a more preferred embodiment, the positioning tube 22 has no connection with the isolation balloon 1, and the end of the positioning tube 22 that enters the body first is the first end, and the opposite end is the second end; the first end of the positioning tube 22 is closed. This method can achieve the purpose of effective inflation through only one inflation tube 21, and avoid the body's liquid from overflowing through the positioning tube 22.

[0085] In a more preferred embodiment, the positioning pipeline 22 is configured as a non-circular pipeline, and the supporting positioning structure 4 is adapted to the non-circular pipeline. Furthermore, the cross-sectional shape of the positioning pipeline 22 includes at least one straight line segment.

[0086] In a more preferred embodiment, the positioning pipeline 22 is configured as a square pipeline, or the positioning pipeline 22 is configured as a semicircular pipeline, or the positioning pipeline 22 is configured as a pipeline with at least one plane.

[0087] In a more preferred embodiment, the positioning conduit 22 and the charging conduit 21 are both arranged on the side of the implant seat 51 and perpendicular to the bottom plane of the implant seat 51. This method can facilitate the combination of the support and positioning structure 4 and the positioning conduit 22, and avoid interference with the implant seat 51 during the installation of the support and positioning structure 4.

[0088] In a more preferred embodiment, referring to FIG5 , a blocking cap 221 is provided at the rear end of the positioning pipe 22 , and the blocking cap 221 is used to seal the positioning pipe 22 after the support positioning structure 4 is withdrawn. This arrangement can effectively ensure the closed state of the soft connecting pipe 2 in the body.

[0089] Example 3

[0090] An isolation device for deep tissue is implanted via a laparoscopic approach. Using the example of isolating pancreatic and gastric tissue undergoing radiotherapy, as shown in Figure 10 , the implanted state in vivo is depicted. The implantation steps of the isolation device are described in detail.

[0091] First, according to conventional laparoscopic gastric surgery procedures, a hole is made in the abdominal wall to establish a laparoscopic and surgical instrument access route. Laparoscopic instruments are used to separate the tissue between the gastric fundus and the pancreas, creating space for the isolation balloon 1.

[0092] Second, a transverse incision approximately 1.5-2 cm long is made at a suitable location along the mid-axillary line in the left upper abdomen. The subcutaneous tissue is gently freed and a small subcutaneous pouch is created. A new laparoscopic approach is established through this location, and the first end of the isolation device is delivered into the abdominal cavity through this approach. The second end corresponding to the inflated connecting structure 3 is left outside the body.

[0093] Third, a laparoscopic instrument is used to place the isolation balloon 1 in the space between the pancreas and the gastric fundus. The non-invasive puncture needle of the filling structure is used to puncture the filling connection structure 3 and inject a mixture of saline and contrast agent to gradually inflate the isolation balloon 1 to a preset balloon shape. During this process, the laparoscopic instrument is used to adjust and fix the balloon in the correct position.

[0094] Fourth, after the isolation balloon 1 is inflated and positioned, the laparoscope poke card at the pouch is removed, the inflation connection structure 3 is fixed in the subcutaneous pouch with sutures, and the skin incision is sutured;

[0095] Fifth, finally remove and suture other laparoscopic incisions;

[0096] Sixth, during the radiotherapy process, the isolation balloon 1 can be inflated and deflated by inflating the connecting structure 3 through percutaneous puncture every day.

[0097] Seventh, after a course of radiotherapy is completed, the mixed liquid of saline and contrast agent is extracted and the isolation balloon 1 is maintained at negative pressure. The original surgical incision is then opened to expose the inflated connecting structure. After removing its fixing line, the inflated connecting structure 3 is dragged to achieve the purpose of withdrawing the entire isolation device from the body.

[0098] Example 4

[0099] An isolation device is applied to superficial tissues. The isolation device is implanted via a puncture path. For example, the isolation device is used to isolate prostate cancer tissue and intestinal tissue undergoing radiotherapy. FIG11 shows the state of the isolation device in vivo after implantation. The specific steps for implanting the isolation device include:

[0100] First, local anesthesia is applied to the pelvic floor skin between the scrotum and anus, an incision of approximately 1.5 cm is made, and the subcutaneous tissue is gently freed and a small pouch is created.

[0101] Second, under rectal ultrasound guidance, a puncture needle is used to penetrate the pelvic floor tissue and enter the interstitial space between the prostate and rectum (Denonvillers' space). A support guidewire is then inserted through the puncture needle. A 12F introducer sheath is then placed along the support guidewire. The sheath tip is then positioned at the top of the prostate (base of the bladder). Confirm the position of the introducer sheath with ultrasound or CT scans and adjust it to ensure it is as coaxial as possible with the prostate centerline.

[0102] Third, the support and positioning structure 4 is set into the positioning pipeline 22; under the support and guidance of the support and positioning structure 4, the isolation device of the present invention is sent into the guide sheath until the first end is flush with the first end of the guide sheath, and then the guide sheath is withdrawn.

[0103] Fourth, under the support and fixation of the support and positioning structure 4, a non-invasive puncture needle is used to repeatedly puncture the sealing structure 53, and then a mixed liquid of saline and contrast agent is injected to gradually fill the isolation balloon 1 to its designed shape. During this process, the balloon position can be confirmed by CT and the support and positioning structure 4 can be used to adjust the position and angle of the isolation balloon 1.

[0104] Fifth, after the isolation balloon 1 is inflated and positioned, the supporting and positioning structure 4 is removed, and the inflated connecting structure 3 is fixed to the subcutaneous tissue using sutures, and the skin incision is sutured.

[0105] Sixth, during the radiotherapy process, the isolation balloon 1 can be inflated and deflated by inflating the connecting structure 3 through percutaneous puncture every day.

[0106] Seventh, after a course of radiotherapy is completed, the mixed liquid of saline and contrast agent is extracted and the isolation balloon 1 is maintained at negative pressure. The original surgical incision is cut open and the inflated connecting structure is exposed. After removing its fixing line, the entire isolation device is completely removed from the body by dragging the inflated connecting structure 3.

[0107] Note: The guide wire and guide sheath are not shown in the figure. They may be the related guide wire and guide sheath for guiding the vascular balloon into the body in the prior art. Since they are not creative, they can be known by combining the description and the prior art. Therefore, no specific illustration is given and it does not affect the overall understanding of the solution.

Claims

1. An implantable tissue isolation device that can be repeatedly inflated and discharged in vivo, characterized in that: These include, The isolation balloon is always placed between the normal tissue to be isolated and the tissue receiving radiotherapy during a radiotherapy course, and is withdrawn from the body after the radiotherapy course ends; when the isolation balloon is placed in the body, it is used to isolate the normal tissue from the tissue receiving radiotherapy after being inflated, and is used to maintain the normal physiological state of the normal tissue and the tissue receiving radiotherapy after being emptied; After being inflated, the isolation balloon comprises two contact surfaces, namely a first contact surface and a second contact surface, wherein the first contact surface contacts normal tissues to be isolated, and the second contact surface contacts tissues to be radiotherapy; When the isolation balloon is inflated, the distance between the first contact surface and the second contact surface is determined according to the specific tissue that needs to be isolated. The minimum distance between the first contact surface and the second contact surface is greater than or equal to the distance required for the radiation dose to drop to the tolerable range of normal tissue, and the maximum distance between the first contact surface and the second contact surface is less than or equal to the maximum distance that the expanded tissue can withstand.

2. The isolation device according to claim 1, characterized in that: The device also includes: an inflation connection structure for connecting the isolation balloon with an external inflation structure; the inflation connection structure is implanted in the subcutaneous tissue, and the inflation connection structure is connected to the inflation structure to realize inflation and emptying of the isolation balloon.

3. The isolation device according to claim 2, characterized in that: The device also includes a soft connecting tube for connecting the inflation connection structure with the isolation balloon. The first end of the soft connecting tube is the end that first enters the body, and the first end of the soft connecting tube is entirely or partially disposed in the isolation balloon. The soft connecting tube is provided with an inflation through hole that is connected to the isolation balloon.

4. The isolation device according to claim 3, characterized in that: The material of the soft connecting pipe is polyetheramide block copolymer, or polytetrafluoroethylene, or polyamide material, or polyurethane.

5. The isolation device according to claim 2, characterized in that: The first end of the isolation balloon is the end that enters the body first, and the first end of the soft connecting tube extends from the first end of the isolation balloon; or, extension tubes are arranged at both ends of the isolation balloon, and the extension tubes are sealed and connected to the soft connecting tube.

6. The isolation device according to claim 2, characterized in that: The filling connection structure includes an implant seat with a connecting cavity, and a repeated puncture sealing structure is fixedly arranged above the implant seat, which can be repeatedly punctured and ensure that it is not connected to the outside; a soft connecting tube is arranged perpendicular to the bottom of the implant seat, and the lumen of the soft connecting tube is connected to the connecting cavity; the filling structure includes a non-invasive puncture needle, and the non-invasive puncture needle punctures the repeatedly punctured sealing structure to communicate with the connecting cavity.

7. The isolation device according to claim 6, characterized in that A method for preventing a non-invasive puncture needle from piercing the soft connecting tube is provided, and the following structure is adopted: A protective baffle with a connecting hole is provided at the connection point between the soft connecting tube and the implant seat, wherein the diameter of the connecting hole is smaller than the outer diameter of the non-invasive puncture needle; Alternatively, the soft connecting tube is arranged vertically at the bottom of the implant seat, and does not overlap with the vertical projection of the repeated piercing sealing structure at the bottom of the implant seat; the repeated piercing sealing structure is reduced and arranged at one side of the implant seat, and the soft connecting tube is arranged at a non-overlapping area on the other side of the bottom of the corresponding implant seat compared with the repeated piercing sealing structure; Alternatively, a communication port is provided in the communication cavity of the implant seat, which is arranged at an angle to the longitudinal direction of the communication cavity, the communication port opens toward the side of the implant seat, and the communication port is connected to the lumen of the soft connecting tube arranged on the side of the implant seat; Alternatively, the length of the non-invasive puncture needle is greater than the thickness of the repeated puncture sealing structure, but less than the sum of the height of the repeated puncture sealing structure and the connecting cavity.

8. The isolation device according to claim 6, characterized in that: The implant seat is also provided with a suture loop for fixing it to the subcutaneous tissue.

9. The isolation device according to claim 1, characterized in that: The first contact surface and the second contact surface are two parallel planes, and the peripheral areas of the first contact surface and the second contact surface corresponding to the isolation balloon are higher than the first contact surface and the second contact surface; or, the peripheral areas of the first contact surface and the second contact surface corresponding to the isolation balloon are higher than the first contact surface and the second contact surface, and an arc-shaped connection is realized between the periphery of the first contact surface and the second contact surface; or, the first contact surface and the second contact surface are curved surfaces which are low in the middle and high on both sides.

10. The isolation device according to claim 1, characterized in that: The first contact surface and the second contact surface are in the same plane, and the projections of the first contact surface and the second contact surface on the horizontal plane overlap.

11. The isolation device according to claim 9, characterized in that: After being inflated, the distance between the first contact surface and the second contact surface ranges from 1 to 2 cm.

12. The isolation device according to any one of claims 1 to 11, characterized in that: The isolation balloon has a drug-loaded coating, wherein the first contact surface carries a radioprotectant and / or a sustained-release local anesthetic, but cannot carry a chemotherapeutic drug; the second contact surface carries a chemotherapeutic drug and / or a sustained-release local anesthetic, but cannot carry a radioprotectant.

13. The isolation device according to claim 2, characterized in that: When the isolation device is implanted by puncture, an inflation pipeline for inflating the isolation balloon is arranged in the soft connecting tube; a positioning pipeline is also arranged in the soft connecting tube; and a supporting positioning structure for adjusting the position and angle of the isolation balloon is arranged inside the positioning pipeline.

14. The isolation device according to claim 13, characterized in that The supporting and positioning structure is a hard supporting rod.

15. The isolation device according to claim 13, characterized in that The charging pipeline and the positioning pipeline are arranged in parallel; the charging pipeline and the positioning pipeline are integrated in a unified soft connecting pipe.

16. The isolation device according to claim 14, characterized in that The isolation balloon is pasted together with the soft connecting tube, and only an inflation through hole communicating with the isolation balloon is provided on the side wall of the inflation pipeline; The positioning pipeline has no connection with the isolation balloon. The end of the positioning pipeline that first enters the body is the first end, and the opposite end is the second end. The first end of the positioning pipeline is closed.

17. The isolation device according to claim 13, characterized in that The positioning pipeline is set as a non-circular pipeline, and the supporting positioning structure is adapted to the non-circular pipeline.

18. The isolation device according to claim 13, characterized in that The positioning pipeline and the charging pipeline are both arranged on the side of the implant seat and are arranged perpendicular to the bottom plane of the implant seat.

19. The isolation device according to claim 13, characterized in that A plugging cap is provided at the rear end of the positioning pipeline, and the plugging cap is used to seal the positioning pipeline after the supporting positioning structure is withdrawn.

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