Instrument for implantable continuous in-vivo spacer tissue

Abstract

The utility model discloses an implantable continuous in-vivo spacing tissue instrument which comprises an isolation balloon and a liquid filling hose, and the first end of the liquid filling hose is communicated with the isolation balloon; the liquid filling tail valve is connected with the second end of the liquid filling hose, the liquid filling tail valve is embedded under the skin of the patient, and a one-way valve for avoiding liquid leakage when the isolation balloon is filled is arranged in the liquid filling tail valve; the liquid filling tail valve and the liquid filling hose are each internally provided with a single pipe cavity used for filling the isolation balloon, or the liquid filling tail valve and the liquid filling hose are each internally provided with at least two pipe cavities arranged in parallel, and one pipe cavity is used for filling the isolation balloon. In addition, the liquid filling tail valve comprises a blocking structure with a blocking disc, and double-layer liquid leakage prevention protection is achieved. In order to facilitate liquid discharge after use, a release structure connected with the liquid filling tail valve is additionally arranged. By means of the arrangement, the effect that in-vivo interval tissue can be continued through one-time liquid filling of the isolation balloon can be well achieved.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to an implantable device for continuously spacing tissues in the body. Background Art

[0002] One problem faced during radiotherapy is the damage of radiotherapy rays to adjacent normal organs and tissues, especially those tissues that are sensitive to radiation, such as the intestines, glands, lymph nodes, etc. While killing tumor cells, radiotherapy rays inevitably cause damage to normal tissues. Without effective protection, various serious and irreversible complications will occur.

[0003] In the prior art, 202310688295.5 is an implantable tissue isolation device that can be repeatedly inflated and discharged in the body. The disclosed technical solution is a tissue isolation device that can be repeatedly inflated and discharged. This technical solution is mainly suitable for some tissues with tight surrounding spaces. If the tissues are separated by a long time interval, it is easy to cause tissue compression and damage; however, in clinical practice, there are some tissues that have small gaps but loose surrounding structures, and placing a spacer for a long time will not cause compression and damage to the tissues. In this way, the devices in the prior art will no longer fully match the above scenarios.

[0004] Therefore, there is a need for an isolation device that can be charged once and continuously set in the spaced tissues in the patient's body, specifically an implantable device that continuously spaces the tissues in the body. Utility Model Content

[0005] Since radiotherapy usually takes 1-2 months, if the isolation device is taken out of the body, it will affect the patient's life. Therefore, a completely implantable method is chosen to ensure that the patient's life will not be affected by the setting of the isolation device during the entire radiotherapy process; but it is necessary to ensure that the balloon is continuously inflated during the radiotherapy process and the liquid is released after the entire radiotherapy is completed. How to achieve the above purpose, the technical solution of the utility model is:

[0006] An implantable device for continuously separating tissues in vivo, comprising

[0007] The isolation balloon is always placed between tissues to maintain an inflated interval state during the treatment cycle;

[0008] A liquid-filled hose, a first end of which is connected to the isolation balloon;

[0009] A filling tail valve is connected to the second end of the filling hose, and the filling tail valve is implanted under the patient's skin; the filling tail valve includes a blocking disk with an outer diameter larger than that of the filling hose, and a one-way valve to prevent leakage when the isolation balloon is inflated inside the filling tail valve;

[0010] The device can be set at the tissue that needs to be isolated by puncture or laparoscopic surgery. When the device is set by puncture, at least two parallel lumens are set in the liquid-filling tail valve and the liquid-filling hose. The two lumens are an inflation lumen for inflating the isolation balloon and a positioning lumen for setting a supporting positioning structure, and the inflation lumen and the positioning lumen are not connected; or, the liquid-filling tail valve and the liquid-filling hose are both set as single lumens, the inflation lumen and the positioning lumen are the single lumens, and the one-way valve is a one-way valve that allows the supporting positioning structure to extend into but keeps the one-way valve structure intact after withdrawal.

[0011] Furthermore, when both the filling tail valve and the filling hose are provided with a single lumen, it is necessary to avoid damage to the one-way valve by the supporting positioning structure. The specific structure is that the supporting positioning structure is a guide wire; when ≥2 parallel lumens are provided in the filling tail valve and the filling hose, the supporting positioning structure is a guide rod.

[0012] Furthermore, the one-way valve is an elastic one-way valve arranged at the front end of the liquid-filling tail valve.

[0013] Furthermore, in order to avoid the change of the instrument position of the filling tail valve due to the patient's activities during use, the following settings are made: a blocking disk with an outer diameter larger than the outer diameter of the filling hose is directly set on the filling tail valve; or the filling tail valve also includes a sealing structure for sealing the liquid filling tail valve lumen after the filling is completed, and the relative position of the sealing structure and the filling tail valve does not change after being combined, and the blocking disk is set on the sealing structure.

[0014] Furthermore, in addition to maintaining the unchanged position, it is also necessary to minimize the possibility of leakage during use; the specific setting method is: the filling tail valve is a cylindrical filling tail valve, a thread section one is set on the filling tail valve, and a thread section two is correspondingly set on the sealing structure.

[0015] Furthermore, in order to improve the stability of the blocking disk, suture holes are provided on the blocking disk, so that the blocking disk can be fixed in the subcutaneous tissue by sutures.

[0016] Furthermore, in order to complete the release of the liquid in the isolation balloon as quickly as possible after the end of radiotherapy, a release structure is set to control the opening of the one-way valve; when it is a one-way valve, the release structure includes a release section extending into the position of the one-way valve; the release section is a push-open tube with an outer diameter smaller than the inner diameter of the liquid-filled tail valve.

[0017] A more specific configuration is that the rear end of the push-open pipe is connected to a transition pipe arranged at the position of the liquid filling tail valve; a threaded section three combined with the threaded section one is arranged on the transition pipe.

[0018] Technical Effects

[0019] Through the setting of the above-mentioned implanted device with a one-way valve, the isolation balloon can be continuously set in an inflated state at the location of the tissue to be isolated. During the process, there is no exposed part of the device outside the patient's body, and the patient's life is not affected, because the inflated state of the isolation balloon does not cause compression damage to the tissue. Continuous isolation also effectively reduces the process of repeated inflation and discharge of the balloon, avoids repeated puncture injuries to the patient and saves time for medical staff.

[0020] By setting the blocking cap on the filling tail valve and the blocking disk on the blocking cap, the purpose of doubly maintaining the stable filling state of the front isolation balloon can be achieved under the premise of ensuring the position stability of the device.

[0021] The setting of the release structure can accelerate the release process of the internal liquid of the isolation balloon after use to the greatest extent, ensuring the smooth use of the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the structure of the support and positioning structure of the utility model being arranged in the device;

[0023] Figure 2 This is a partial enlarged structural diagram of the rear end portion of the support and positioning structure of the utility model disposed in the instrument;

[0024] Figure 3 This is a schematic diagram of the overall structure of the device with a blocking structure of the utility model;

[0025] Figure 4 It is a partial enlarged structural schematic diagram of the liquid-filled tail valve with two longitudinal sections of the utility model;

[0026] Figure 5 This is a schematic diagram of the structure of the plugging structure of the utility model;

[0027] Figure 6 It is a schematic diagram of a partially enlarged structure of a corresponding part of the threaded section of the utility model;

[0028] Figure 7 It is a longitudinal cross-sectional structural schematic diagram of the release structure of the utility model after it extends into the liquid filling tail valve;

[0029] Description of main reference numerals

[0030] 1. Isolation balloon; 2. Liquid-filling hose; 3. Liquid-filling tail valve; 31. One-way valve; 32. Sealing structure; 321. Blocking disk; 3211. Suture hole; 322. Threaded segment two; 33. Threaded segment one; 4. Support and positioning structure; 5. Release structure; 51. Push-open tube; 52. Transition tube; 53. Threaded segment three. DETAILED DESCRIPTION

[0031] refer to Figure 1—3; An implantable device for continuously separating tissues in the body, comprising an isolation balloon 1, which is always arranged between tissues to maintain an inflated spacing state during the treatment cycle; a liquid filling hose 2, the first end of which is connected to the isolation balloon 1; a liquid filling tail valve 3, which is connected to the second end of the liquid filling hose 2, and the liquid filling tail valve 3 is implanted under the patient's skin; the liquid filling tail valve 3 includes a blocking disk 321 with an outer diameter larger than that of the liquid filling hose 2, and a one-way valve 31 is arranged inside the liquid filling tail valve 3 to prevent air leakage;

[0032] refer to Figure 1 —4, when the device is set by puncture, at least two parallel lumens are set in the filling tail valve 3 and the filling hose 2, the two lumens are the filling lumen for filling the isolation balloon 1 and the positioning lumen for setting the support positioning structure 4, and the filling lumen and the positioning lumen are not connected; or, the filling tail valve 3 and the filling hose 2 are both set as a single lumen, the filling lumen and the positioning lumen are the single lumen, and the one-way valve 31 is a one-way valve 31 that allows the support positioning structure 4 to extend into but the one-way valve 31 structure is intact after withdrawal. A more preferred embodiment, refer to Figure 2 and Figure 4 When there is a single lumen, in order to better avoid the damage of the guide structure 4 to the one-way valve 31, the support and positioning structure 4 is a thin guide wire; the guide wire can both achieve guidance and positioning and avoid damage to the one-way valve 31. However, when there are two or more lumens, the support and positioning structure 4 can be a guide rod, which has stronger positioning and supporting effects and is more convenient to use.

[0033] When the device is set up through laparoscopy, the filling tail valve 3 and the filling hose 2 can be optionally set up as a single cavity, and no supporting positioning structure is required. The isolation balloon can be delivered to the tissue that needs to be isolated through the laparoscopic device under direct vision of the laparoscope.

[0034] A more preferred embodiment is as follows Figure 2 and Figure 4 The one-way valve 31 is an elastic one-way valve arranged at the front end of the liquid filling tail valve 3; the elastic one-way valve is suspended in the direction of the isolation balloon 1 and has an opening, and the bottom is arranged close to the side wall of the liquid filling tail valve 3 in the direction of the liquid filling tail valve 3. This valve-type one-way valve 31 is a structure with simple arrangement, good one-way effect, and easy opening during the release process.

[0035] The one-way valve 31 may also be other one-way valve bodies that are arranged on the liquid filling tail valve 3 and are capable of one-way filling, such as a check valve of appropriate size.

[0036] A more preferred embodiment is as follows Figure 3 A blocking disk 321 having an outer diameter larger than that of the filling hose 2 is directly arranged on the filling tail valve 3; or Figure 3-6The liquid-filling tail valve 3 also includes a blocking structure 32 for blocking the lumen. After the blocking structure 32 and the liquid-filling tail valve 3 are combined, the relative position does not change, and the blocking disk 321 is arranged on the blocking structure 32. In this way, the liquid-filling tail valve 3 can be prevented from entering the patient's body and leaving the implanted part due to the patient's activities during use, which affects the removal. A more preferred embodiment is that the blocking disk 321 is a disk-shaped structure arranged at the rear end of the blocking structure 32, and the rear end of the disk-shaped structure is in the shape of an umbrella. This shape setting can ensure the stability of the structural setting and effectively protect the tissue.

[0037] A more preferred embodiment is as follows Figure 5 The blocking disk 321 is provided with a suture hole 3211, and the suture hole 3211 is provided to further achieve stability in the position setting of the filling tail valve 3. When in use, the suture is passed through the suture hole 3211 and sutured into the subcutaneous tissue at the incision. At least one suture hole 3211 is provided, and the number may be 1-4.

[0038] A more preferred embodiment is as follows Figure 5 and Figure 6 The filling tail valve 3 is a cylindrical filling tail valve 3, on which a threaded section 33 is arranged, and on the sealing structure 32 a corresponding threaded section 322 is arranged. In this way, an effective closed combination can be achieved. In addition to preventing the filling tail valve 3 from moving with the connecting hose, a layer of sealing insurance can be added to the outside of the filling tail valve 3 to avoid leakage during use.

[0039] In a more preferred embodiment, after the threaded segment 1 33 and the threaded segment 2 322 are combined, the outer wall of the liquid filling tail valve 3 is smooth and has no protrusions. This arrangement will not change the outer diameter of the entire structure due to the setting of the plugging cap, so that it maintains the original continuity. A more specific method is: the outer diameter of the liquid filling tail valve 3 corresponding to the threaded segment 1 33 is smaller than the main body; the thread of the threaded segment 1 33 is on the outside, the plugging structure 32 is sleeved on the outside of the liquid filling tail valve 3, the thread of the threaded segment 2 322 is set on the inside of the plugging structure 32, and the outer diameter of the plugging structure 32 is the same as the outer diameter of the main body of the liquid filling tail valve 3; after the combination, the plugging structure 32 contacts the main body; or the threaded segment 1 33 is set inside the liquid filling tail valve 3, the threaded segment 2 322 is set on the outside of the plugging structure 32, and the threaded segment 2 322 extends into the threaded segment 1 33; the above purpose is achieved by extending the threaded segment 2 322 into the threaded segment 1 33.

[0040] A more preferred embodiment is as follows Figure 7 A release structure 5 is provided for controlling the one-way valve 31 to open and release the substance in the isolation balloon 1 after use; the release structure 5 includes a release section extending into the one-way valve position, and the release section is a push-open tube 51 having an outer diameter smaller than the inner diameter of the liquid-filled tail valve 3.

[0041] More specifically, the rear end of the push-open tube 51 is connected to a transition tube 52 disposed at the position of the liquid filling tail valve 3; the transition tube 52 is provided with a threaded section 3 53 combined with the threaded section 1 33, and the lumen of the transition tube 52 is communicated with the lumen of the push-open tube 51 and with the outside. Further, an extension tube is provided behind the transition tube 52, and the extension tube is provided for the convenience of operation and for the convenience of draining the liquid when the substance of the liquid filling isolation balloon 1 is liquid.

[0042] In a more preferred embodiment, the isolation balloon 1 comprises two parallel planes after being inflated, wherein the first parallel plane contacts the radiotherapy tissue, and the second parallel plane contacts the normal tissue.

[0043] The filling structure is a syringe or a syringe pump, and the filled substance is a mixture of physiological saline and contrast agent.

[0044] When in use, according to the puncture setting method, first make an opening at the skin, extend the supporting positioning structure 4 through the positioning tube cavity on the filling tail valve 3 into the filling hose 2 and into the position of the isolation balloon 1, and send the isolation balloon 1 to the accurate position under the support and guidance of the supporting positioning structure; then connect the inflation structure with the filling tail valve 3 to complete the inflation of the isolation balloon 1, then withdraw the inflation structure and the supporting positioning structure 4, set the blocking structure 32 with the blocking disk 321 on the filling tail valve 3, and finally fix the filling tail valve 3 in the subcutaneous tissue with sutures, and suture the skin incision; after the entire radiotherapy process is completed, make an incision at the implantation site to expose the filling tail valve 3, open the one-way valve 31 under the control of the external structure, extract the liquid in the isolation balloon 1 and maintain the negative pressure state, and take out the entire device by withdrawing the filling tail valve 3.

[0045] Regarding the method of laparoscopic implantation, take the isolation of abdominal viscera as an example: skin incision, penetrate the subcutaneous tissue (a puncture sheath or puncture card can be used), send the isolation balloon 1 into the abdominal cavity through the puncture sheath or puncture card, use laparoscopic instruments under direct vision of the laparoscope to send the isolation balloon 1 to the position that needs to be isolated, connect the inflation structure with the filling tail valve 3 to complete the inflation of the isolation balloon 1, remove the puncture sheath or puncture card, set the sealing structure 32 with the blocking disk 321 on the filling tail valve 3, and finally fix the filling tail valve 3 in the subcutaneous tissue with sutures, and suture the skin incision; after the entire radiotherapy process is completed, make an incision at the implantation site to expose the filling tail valve 3, open the one-way valve 31 under the control of the external structure, extract the liquid in the isolation balloon 1 and maintain a negative pressure state, and remove the entire device by withdrawing the filling tail valve 3.

[0046] The technical solutions in the embodiments of the utility model are clearly and completely described above through specific embodiments. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of them. Those skilled in the art can easily understand other advantages and functions of the utility model from the contents disclosed in this specification. The utility model can also be implemented or applied through other different specific implementation methods. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

Claims

1. An implantable continuous in vivo spacer tissue device, comprising: The isolation balloon is always placed between tissues to maintain an inflated interval state during the treatment cycle; The first end of the liquid-filled hose is connected to the isolation balloon, and is characterized in that: Also includes The filling tail valve is connected to the second end of the filling hose. The filling tail valve is implanted under the patient's skin. A one-way valve is arranged inside the filling tail valve to prevent leakage when the isolation balloon is inflated.

2. The implantable continuous in vivo spacer tissue device according to claim 1, characterized in that: The instrument is set at the tissue that needs to be isolated by puncture or laparoscopic surgery; when the instrument is set by puncture, at least two parallel lumens are set in the filling tail valve and the filling hose, the two lumens are the filling lumen for inflating the isolation balloon and the positioning lumen for setting the supporting positioning structure, and the filling lumen is not connected with the positioning lumen; the one-way valve is a one-way valve that allows the supporting positioning structure to extend but the one-way valve structure is intact after withdrawal; or, the filling tail valve and the filling hose are both set with a single lumen, and the filling lumen and the positioning lumen are the single lumen combined into one.

3. The implantable continuous in vivo spacer tissue device according to claim 1, characterized in that: The one-way valve is an elastic one-way valve arranged at the front end of the filling tail valve; the elastic one-way valve is suspended in the direction of the isolation balloon and has an opening, and its bottom is arranged close to the side wall of the filling tail valve in the direction of the filling tail valve.

4. The implantable continuous in vivo spacer tissue device according to claim 1, characterized in that: A blocking disk with an outer diameter larger than that of the filling hose is directly arranged on the filling tail valve; or the filling tail valve also includes a sealing structure for sealing the inner lumen of the filling tail valve after the filling is completed. The relative position of the sealing structure and the filling tail valve does not change after being combined, and a blocking disk with an outer diameter larger than that of the filling hose is arranged on the sealing structure.

5. The implantable continuous in vivo spacer tissue device according to claim 4, characterized in that: The blocking disk is a disk-shaped structure arranged at the rear end of the blocking structure, and the rear end of the disk-shaped structure is in the shape of an umbrella cover.

6. The implantable continuous in vivo spacer tissue device according to claim 5, characterized in that: The liquid-filling tail valve is a cylindrical liquid-filling tail valve, a threaded section one is arranged on the liquid-filling tail valve, and a threaded section two is arranged on the sealing structure corresponding to the threaded section one.

7. The implantable continuous in vivo spacer tissue device according to claim 6, characterized in that: After the threaded section one and the threaded section two are combined, the outer side wall of the liquid-filled tail valve is smooth without protrusions.

8. The implantable continuous in vivo spacer tissue device according to claim 7, characterized in that: The outer diameter of the liquid-filled tail valve corresponding to the threaded segment one is smaller than that of the main body; the thread of the threaded segment one is on the outside, the sealing structure is sleeved on the outside of the liquid-filled tail valve, the thread of the threaded segment two is arranged on the inside of the sealing structure, and the outer diameter of the sealing structure is the same as the outer diameter of the main body of the liquid-filled tail valve; or the threaded segment one is arranged inside the liquid-filled tail valve, the threaded segment two is arranged on the outside of the sealing structure, and the threaded segment two extends into the threaded segment one.

9. The implantable continuous in vivo spacer tissue device according to any one of claims 4 to 8, characterized in that: Suture holes are arranged on the blocking disk.

10. The implantable continuous in vivo spacer tissue device according to claim 1, characterized in that: The device is also provided with a release structure for controlling the one-way valve to open and release the substance in the isolation balloon after use; the release structure includes a release section extending into the one-way valve position; the release section is a push-open tube with an outer diameter smaller than the inner diameter of the liquid-filled tail valve; The rear end of the push-open pipe is connected to a transition pipe arranged at the position of the liquid filling tail valve; a threaded section three combined with the threaded section one is arranged on the transition pipe, and the lumen of the transition pipe is communicated with the lumen of the push-open pipe and with the outside world.

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