CN219983735U

CN219983735U - Puncture implantation radiotherapy tissue isolation device capable of being repeatedly charged and discharged in vivo

Info

Publication number: CN219983735U
Application number: CN202321480562.1U
Authority: CN
Inventors: 刘晓鹏
Original assignee: Beijing Pulandun Medical Technology Co ltd
Current assignee: Beijing Pulandun Medical Technology Co ltd
Priority date: 2023-06-12
Filing date: 2023-06-12
Publication date: 2023-11-10
Anticipated expiration: 2033-06-12

Abstract

A puncture-implanted radiotherapy tissue isolation device capable of being repeatedly inflated and deflated in a body comprises an isolation balloon for isolating normal tissues from tissues receiving radiotherapy; the charging 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 treated; the distance between the first contact surface and the second contact surface can be preset and adjusted according to the requirement. A soft connecting pipe is arranged to connect the isolation saccule and the charging connecting structure positioned under the skin. The soft connecting pipe and the filling connecting structure are internally provided with a filling pipeline and a positioning pipeline for filling the isolation balloon, and the inside of the positioning pipeline can be provided with a supporting and positioning structure for adjusting the position of the isolation balloon. After the support positioning structure is placed in the positioning pipeline, under the guidance of CT or ultrasonic images, the support positioning structure can drive the isolation balloon to move and rotate in the body, so that the isolation balloon reaches a preset position and is in correct contact with corresponding tissues after being inflated.

Description

Puncture implantation radiotherapy tissue isolation device capable of being repeatedly charged and discharged in vivo

Technical Field

The utility model belongs to the technical field of medical appliances, and particularly relates to a protective appliance used during radiotherapy, in particular to a puncture implanted radiotherapy tissue isolation device capable of being repeatedly charged and discharged in vivo.

Background

Tumor radiotherapy is a local treatment method for treating tumors by using radiation. The radiation mainly includes high-energy X-rays generated by an accelerator, electron beams, proton beams, and the like. About 70% of cancer patients require radiation therapy in the course of treatment of cancer, and about 40% of cancer can be cured by radiation therapy. The role and position of radiation therapy in tumor therapy are increasingly prominent, and radiation therapy has become one of the main means for treating malignant tumors.

The biggest problem faced by tumor radiotherapy is the protection of adjacent normal organs and tissues, especially those that are radiation sensitive, such as: intestinal tract, gland, lymph, etc. Aiming at isolation of shallower position tissues, the prior art discloses a CN 202110281992-a prostate and rectum isolation device; the ellipsoidal isolation instrument is characterized in that the ellipsoidal isolation instrument is provided with an elliptical cavity, the ellipsoidal cavity is provided with a plurality of triangular cavities, the triangular cavities are provided with a plurality of triangular cavities, and the triangular cavities are provided with a plurality of triangular cavities.

Aiming at the technical problems, the utility model provides a puncture-implanted radiotherapy tissue isolation device capable of being repeatedly charged and discharged in a body.

Disclosure of Invention

Distance protection is still the most dominant and effective protection means at present. The modern radiotherapy instrument has very high precision, and the radiation dose can be obviously reduced by isolating normal tissues by a distance of 1-2cm, so that the occurrence of complications is greatly reduced. How to effectively realize effective and stable distance protection between normal tissues and radiotherapy tissues is a technical problem to be solved.

In addition, for isolation of tissue located more superficial (e.g. prostate cancer tissue from rectal tissue), the prior art (CN 202110281992), while provided with isolation, suffers from two distinct drawbacks: 1. the distance formed by the ellipsoidal arrangement mode is the middle large edge small, so that the stable distance is difficult to form; 2. the periodicity of radiotherapy is not considered in the prior art, a radiotherapy treatment course usually needs to last for 4-8 weeks to carry out 20-40 times, but the prior art is not completely implanted in vivo design, and patients cannot carry for a long time, and repeated implantation and extraction of each treatment are not feasible. In order to solve the above problems, it is required that: 1. designing the cross section of the balloon to be a non-circular surface; 2. the entire device is fully implanted in the body. The balloon is designed to be non-circular, and the position and angle of the balloon need to be adjusted in the process of being placed in the non-circular shape, so that the balloon is accurately aligned with corresponding tissues, and for a device manufactured by hard materials, the synchronous movement and rotation of the balloon are realized by moving or rotating the tail end of the device. However, to achieve a fully implanted design, the connecting tube portion of the device needs to be as flexible as possible to reduce tissue damage and patient discomfort, which makes it difficult to move and rotate the isolation balloon by moving or rotating the tail end of the device. The method comprises the following steps:

a puncture-implanted radiotherapy tissue isolation device capable of being repeatedly filled and discharged in a body, which comprises,

the isolation saccule is used for isolating normal tissues and radiotherapy tissues; the charging 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 receiving radiotherapy; the minimum distance between the first contact surface and the second contact surface is not less than the distance required by the radiation dose to drop to the tolerable dose of normal tissues; and/or the maximum distance is not greater than the maximum distance that the distracted tissue can withstand;

the soft connecting pipe firstly enters the inner end of the body to be a first end; the first end of the soft connecting pipe is arranged in the isolation balloon or extends out from the first end of the isolation balloon, and a filling pipeline for filling the isolation balloon is arranged in the soft connecting pipe; the soft connecting pipe also comprises a positioning pipeline, and the positioning pipeline is internally provided with a supporting and positioning structure for adjusting the position and the angle of the isolation balloon.

When the isolation balloon enters the body and is arranged between normal tissues and tissues receiving radiotherapy, the supporting and positioning structure is arranged in the positioning pipeline, and the position and the angle of the isolation balloon are adjusted by moving and rotating the supporting and positioning structure in vitro. The isolation saccule is ensured to be accurately positioned between radiotherapy tissues and tissues needing to be isolated, and the two contact surfaces of the isolation saccule are accurately aligned with corresponding tissues.

The apparatus further comprises:

filling up the connecting structure; the filling structure is used for connecting the flexible connecting pipe with the outside of the body; the inflation connecting structure is in sealing arrangement when not connected with the inflation structure and is used for maintaining inflation and evacuation states of the isolation balloon.

The charging connecting structure is provided with a positioning port corresponding to the positioning pipeline and is arranged at the end part of the positioning pipeline.

Further, the positioning pipeline is arranged as a non-circular pipeline.

Further, the supporting and positioning structure is a hard supporting rod and is matched with a non-circular positioning pipeline. The position and the angle of the isolation balloon arranged in the body can be quickly adjusted through the hard supporting rod.

Further, the charging connection structure is a structure which can be implanted subcutaneously. Can be used repeatedly by being implanted subcutaneously, does not influence the normal life of a patient, and reduces the trouble of each implantation.

The utility model has the beneficial effects that:

1. the purpose of establishing a stable isolation distance is realized by a mode of defining the arrangement of two contact surfaces of the minimum distance;

2. the support positioning structure is arranged in the positioning pipeline, the position and the angle of the isolation balloon in the body are adjusted by moving and rotating the support positioning structure, the isolation balloon is ensured to be accurately positioned between radiotherapy tissues and tissues needing to be isolated, and the two contact surfaces of the isolation balloon are accurately aligned with the corresponding tissues.

Drawings

FIG. 1 is a schematic diagram of the overall structure of the embodiment of the present utility model with a charging pipe disposed laterally and vertically to an implant seat;

FIG. 2 is a schematic view of the structure of the lower side of the whole structure of the embodiment of the utility model in which the charging pipe is arranged at the side of the implantation seat and is arranged vertically to the implantation seat;

FIG. 3 is a schematic view of the structure of the isolation balloon with support and positioning structure and without the implant seat part and the flexible connecting tube according to the present utility model;

FIG. 4 is a schematic view of a partially longitudinal cross-sectional structure of the charge connection structure of the present utility model;

FIG. 5 is a schematic cross-sectional view of a flexible connecting tube including a fill line and a positioning line according to the present utility model;

FIG. 6 is a schematic view of the isolation balloon with a plane bottom as a section and its internal soft connection tube structure according to the present utility model;

FIG. 7 is a schematic diagram showing the structure of the isolation balloon of the present utility model in an embodiment between the prostate and the rectum; wherein the soft connecting pipe is arranged at the side of the implantation seat and is arranged at the bottom of the vertical implantation seat.

FIG. 8-A is a schematic cross-sectional view of an isolation balloon of the present utility model in cross-section with the anterior aspect;

FIG. 8-B is a schematic cross-sectional view of the isolation balloon of the present utility model in cross-section from the upper viewing surface;

fig. 8-C is a schematic cross-sectional view of the isolation balloon of the present utility model with the right side view in cross-section.

Description of the main reference numerals

1. An isolation balloon; 11. a first contact surface; 12. a second contact surface; 13. an extension tube; 2. a flexible connecting tube; 21. filling up the pipeline; 211. filling up the through hole; 22. positioning a pipeline; 221. a plugging cap; 222. a positioning port; 3. filling up the connecting structure; 4. a support positioning structure; 51. an implantation seat; 52. a communication chamber; 53. repeatedly puncturing the sealing structure; 55. a communication port; 56. suture loops.

Detailed Description

Example 1

Referring to fig. 1, 2, 3, 5; a puncture-implanted radiotherapy tissue isolation device capable of being repeatedly filled and discharged in a body, which comprises,

the isolation saccule 1 is used for isolating normal tissues and radiotherapy tissues; the charging device comprises two contact surfaces, namely a first contact surface 11 and a second contact surface 12; the first contact surface 11 contacts normal tissues to be isolated, and the second contact surface 12 contacts tissues to be subjected to radiotherapy; the minimum distance between one contact surface and the second contact surface 12 is not less than the distance required for the radiation dose to drop to a normal tissue tolerable dose;

a flexible connecting pipe 2 defining an inner end of the first entering body as a first end; the first end of the soft connecting pipe 2 is arranged in the isolation balloon 1 or extends out from the first end of the isolation balloon 1, and a filling pipeline 21 for filling the isolation balloon 1 is arranged in the soft connecting pipe 2; the soft connecting pipe 2 also comprises a positioning pipeline 22, and the positioning pipeline 22 accommodates a supporting and positioning structure 4 for adjusting the position and the angle of the isolation balloon 1.

The charging connecting structure 3 is provided with a positioning port 222 for positioning the pipeline 22.

When the isolation balloon 1 enters the body and is arranged between normal tissues and tissues receiving radiotherapy, the supporting and positioning structure 4 is arranged in the positioning pipeline 22, and the position and the angle of the supporting and positioning structure 4 are adjusted in vitro to realize the adjustment of the position and the angle of the isolation balloon 1. Ensuring that the first contact surface 11 contacts the tissue to be isolated and the second contact surface 12 contacts the tissue receiving radiation therapy. The tissue receiving radiation therapy is tumor tissue.

Specifically, the supporting and positioning structure 4 is a hard supporting rod. The position and angle of the isolation balloon 1 arranged in the body can be quickly adjusted by moving or rotating the hard support rod.

In a more preferred embodiment, the positioning channel 22 is provided as a non-circular channel, and the support positioning structure 4 is adapted to the non-circular channel. It can also be described that the cross-sectional shape of the positioning tube 22 includes at least one straight edge.

In a more preferred embodiment, the positioning tube 22 is provided as a square tube, or the positioning tube 22 is a semicircular tube, or the positioning tube 22 is a tube with at least one flat surface.

In a more preferred embodiment, the charging line 21 is arranged in parallel with the positioning line 22; the filling pipe 21 and the positioning pipe 22 are integrated in the unified soft connecting pipe 2, and preferably, the filling pipe 21 and the positioning pipe 22 are two independent pipes in the complete soft connecting pipe 2; the filling pipeline 21 and the positioning pipeline 22 divide the tube cavity of the soft connecting tube 2 equally; alternatively, the filling pipe 21 and the positioning pipe are stuck together to form the flexible connecting pipe 2. The setting difficulty of the pipeline can be reduced through parallel arrangement.

More preferred embodiments, refer to fig. 6; the soft connecting pipe 2 penetrates into the isolation balloon 1 and extends out of the first end of the isolation balloon 1, and a filling through hole 211 communicated with the isolation balloon 1 is arranged on the side wall of the filling pipeline 21; the two ends of the isolation saccule 1 are provided with extension pipes 13, the extension pipes 13 are connected with the soft connecting pipe 2 in a sealing way, and the sealing state is realized by a bio-glue pasting way. To ensure that the flexible connecting tube 2 inflates the isolation balloon 1.

In a more preferred embodiment, the first end of the flexible connecting tube 2 is closed; the positioning pipeline 22 is not communicated with the isolation balloon 1, so that the purpose of effectively inflating is achieved through the lateral inflation through holes 211 of the inflation pipeline 21, the communication between the isolation balloon 1 and the outside can be effectively avoided, the pipeline environment is protected, and pollution is avoided.

In a more preferred embodiment, the apparatus further comprises:

filling up the connecting structure 3; a filling structure for connecting the flexible connecting tube 2 with the outside of the body; the inflation connection structure 3 includes a sealing structure for maintaining the inflation line 21 not in communication with the outside when the inflation structure is not connected, for maintaining the inflated and deflated states of the isolation balloon 1. The sealing structure can be like CN 202110281992-a control valve mode in a prostate and rectum isolation device, or refer to fig. 1, 2, 4; the seal structure includes an implant seat 51 implanted in subcutaneous tissue with a repeatedly penetrable seal structure 53.

In a more preferred embodiment, when the charging connection 3 comprises an implantation seat 51; the second end of the positioning pipeline 22 is provided with a plugging cap 221 for supporting a positioning opening 222 of the positioning pipeline 22 after the positioning structure 4 is withdrawn. This arrangement can effectively ensure the closed state of the integral flexible connecting tube 2 in the non-inflated state.

The flexible connecting pipe 2 is made of medical polymer materials; among them, a medical silicone tube is preferable, or the material of the flexible connection tube 2 is polyether amide block copolymer (Pebax), polytetrafluoroethylene (PTFE), polyamide material (PA), polyurethane (PU); through this kind of setting can guarantee that soft connecting pipe 2 sets up in the internal for a long time, and can not cause the damage to internal tissue because of patient's activity, the security is high.

In a more preferred embodiment, the distance between the first contact surface 11 and the second contact surface 12 is preset when the balloon is manufactured, and can be adjusted according to the requirement; the preset distance is based on the distance that the radiation dose drops to a tolerable dose for normal tissues;

more preferably, the minimum distance between the first contact surface 11 and the second contact surface 12 is not less than the distance required for the radiation dose to drop to a normal tissue tolerable dose;

more preferred embodiments are based on the above embodiments 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 can be tolerated by the distracted tissue.

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 are overlapped; the completely same 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 planes arranged in parallel; the plane that parallel arrangement can effectually maintain stable distance, and whole distance is unanimous. The peripheral areas of the first contact surface 11 and the second contact surface 12 corresponding to the isolation balloon 1 are not higher than the peripheral areas of the first contact surface 11 and the second contact surface 12, and arc connection between the peripheries of the first contact surface 11 and the second contact surface 12 is realized; this arrangement ensures that unnecessary isolated pressure is not applied to surrounding tissue and that tissue protection is better.

After the filling, the distance between the first contact surface 11 and the second contact surface 12 is not smaller than the distance required by the radiation dose to be reduced to the dose which can be tolerated by normal tissues, the distance between the first contact surface 11 and the second contact surface 12 is not larger than the maximum distance which can be tolerated by the tissues to be propped, and when the two distances conflict, the distance is not larger than the maximum distance which can be tolerated by the tissues to be propped. More preferably, the minimum distance between the first contact surface 11 and the second contact surface 12 is in the range of 1-2cm;

more preferred embodiments refer to FIGS. 8-A, 8-B, 8-C; the first contact surface 11 and the second contact surface 12 are arranged in an elliptical shape or a slot shape, and the upper surface of the whole isolation balloon 1 is in a slot shape in a view; the left and right surface view shape is a notch shape; the front and rear view is also notch-shaped.

More preferred embodiments are those in which the material of the walls of the first contact surface 11 and the second contact surface 12 is different from the material of the other portions of the isolation balloon 1, and the walls of the first contact surface 11 and the second contact surface 12 are made of an inelastic material, or the entire isolation balloon 1 is made of an inelastic soft material. This approach is easy to form into a planar shape, maintaining distance effectiveness. Preferably, the isolation balloon 1 is integrally formed in vitro, blown in a mold; this preparation method ensures the ease of the preparation method of the isolation balloon 1.

More preferred embodiments are that the isolation balloons 1 with different types are arranged, the soft connecting pipes 2 with different lengths are arranged according to the requirements of different areas, and different types are selected according to the requirements of the operation area.

More preferred embodiments are those wherein the isolation balloon 1 is provided with a drug-loaded coating, wherein the first contact surface 11 is provided with a drug coating carrying a radioprotectant and/or a slow release local anesthetic but not a chemotherapeutic drug; the second contact surface 12 is provided with a drug coating carrying a chemotherapeutic agent and/or a slow release local anesthetic but not a radioprotectant. The local severe pain caused by the tissue distraction can be effectively solved by carrying the slow-release local anesthetic, the chemotherapy can be simultaneously obtained in the whole radiotherapy period by carrying the chemotherapy by the second contact surface 12, and the dual-treatment effect is more remarkable.

When the isolation balloon 1 is used, firstly, an access channel is established by using a puncture guide wire, then the isolation balloon 1 is arranged in an introducer sheath through a support positioning structure 4, the guide wire and the introducer sheath can select a guide wire and an introducer sheath in a vascular balloon access body in the prior art, then the isolation balloon 1 is sent into a basically accurate region needing to be isolated through the introducer sheath, then the isolation balloon 1 is filled by a communication filling structure such as a syringe or a pressure pump with a noninvasive puncture needle, the position condition of the isolation balloon 1 is known through ultrasound or CT, then the isolation balloon 1 is driven to move through the support positioning structure 4, or the support positioning structure 4 is rotated to realize the adjustment of the angle of the isolation balloon 1, and the support positioning structure 4 is withdrawn after the position and the angle of the isolation balloon 1 are adjusted.

Example 2

On the basis of example 1, when the charging connection structure 3 is a subcutaneously implanted structure, the following embodiment,

referring to fig. 1, 2, 4; filling up the connecting structure 3; an inflation structure for connecting the isolation balloon 1 with the outside of the body; the inflation connecting structure 3 is implanted and arranged under the skin, and the inflation connecting structure 3 is connected with the inflation structure to realize inflation and evacuation of the isolation balloon 1.

Note that: the filling structure may be a manual syringe with a non-invasive puncture needle, a filling pump, or other filling device that may be connected to the filling connection structure 3.

More preferred embodiments, refer to fig. 1, 2, 4; the filling connecting structure 3 is an implantation seat 51 with a communication cavity 52; a repeated puncture sealing structure 53 which can repeatedly puncture and ensure that the repeated puncture sealing structure is not communicated with the outside is fixedly arranged above the implantation seat 51; a soft connecting pipe 2 is arranged below the implantation seat 51, the lumen of the soft connecting pipe 2 is communicated with the lumen of the communicating pipe, the filling structure is provided with a noninvasive puncture needle, and the noninvasive puncture needle pierces a repeated puncture sealing structure 53 to be communicated with the communicating cavity 52.

A communication port 55 which is at a certain angle with the longitudinal direction of the communication cavity 52 is arranged in the communication cavity 52 of the implantation seat 51; the communication port 55 is communicated with the charging pipeline 21 of the flexible connecting pipe 2; by the mode, the possibility that the flexible connecting pipe 2 is contacted with the noninvasive puncture needle is effectively avoided, and the puncture is avoided to the greatest extent. More preferably, the communication port 55 faces longitudinally of the vertical communication chamber 52, and the communication port 55 is provided on the side of the implant seat 51. Such a setting can ensure setting security. When the puncture is realized through the arrangement mode, the puncture risk of the noninvasive puncture to the flexible connecting pipe is prevented.

In a more preferred embodiment, the flexible connection pipe 2 is smoothly arranged in the whole entering path, and the arrangement can effectively avoid the blockage of the pipe cavity of the flexible connection pipe 2 caused by bending.

More preferably, the implant seat 51 is further provided with a suture loop 56 for securing it to the skin, and effective securement of the implant seat 51 is achieved by providing the suture loop 56.

In a more preferred embodiment, the implant seat 51 is made of a medical hard material except for the repeatedly puncturing sealing structure 53, so that the implant seat 51 can be conveniently fixed, and the safety of the implant seat 51 is ensured, and the implant seat 51 is prevented from being punctured.

In a more preferred embodiment, the middle part of the isolation balloon 1 is provided with a soft connecting pipe 2, and the isolation balloon 1 and the soft connecting pipe 2 are provided with corresponding inflation through holes 211, so that no gap exists at the joint of the isolation balloon 1 and the soft connecting pipe 2 to ensure that the soft connecting pipe 2 inflates the isolation balloon 1.

Example 3

An isolation device applied to superficial tissues is implanted through a puncture path, taking the isolation of prostate cancer tissues receiving radiotherapy from intestinal tissues as an example, and referring to fig. 7, an in-vivo state diagram of the isolation device after implantation is shown. Specifically, the steps for implanting the isolation device include:

first, the pelvic floor skin between scrotum and anus was locally anesthetized, an incision of about 1.5cm was made, subcutaneous tissue was gently dissociated and a pouch was constructed.

Second, under rectal ultrasound guidance, a puncture needle is used to penetrate pelvic floor tissue, enter the tissue space (Denno villers space) between the prostate and rectum, feed a support guidewire through the puncture needle, and then place an introducer sheath (12F) along the support guidewire, and deliver the tip of the introducer sheath to the top of the prostate (cystal) site. And meanwhile, confirming the position of the guide sheath by ultrasonic or CT and adjusting the guide sheath to be coaxial with the central line of the prostate as much as possible.

Thirdly, the supporting and positioning structure 4 is arranged in the positioning pipeline 22; the isolation device is sent into the guide sheath under the support and guide of the support and positioning structure 4 until the first end is level with the first end of the guide sheath, and then the guide sheath is withdrawn.

Fourth, under the supporting and fixing actions of the supporting and positioning structure 4, the non-invasive puncture needle is used to penetrate through the repeated puncture sealing structure 53, and then the mixed liquid of the physiological saline and the contrast agent is injected to enable the isolation balloon 1 to be gradually filled to the designed shape, and in the process, the position of the isolation balloon can be confirmed through CT and the position and angle of the isolation balloon 1 can be adjusted through the supporting and positioning structure 4.

Fifth, after the isolation balloon 1 is filled and positioned, the supporting and positioning structure 4 is removed, the filling and connecting structure 3 is fixed in the subcutaneous tissue by using a suture, and the skin incision is sutured.

Sixth, in the radiotherapy process, the isolation balloon 1 can be inflated and deflated by inflating the connection structure 3 through percutaneous puncture every day.

Seventh, after one radiotherapy treatment course is finished, the mixed liquid of normal saline and contrast agent is pumped out, the isolation balloon 1 is kept under negative pressure, the original operation incision is cut, the charging connection structure is exposed, and after the fixing line of the isolation balloon is removed, the whole isolation device is completely withdrawn from the body through dragging the charging connection structure 3.

Note that: the guide wire and guide sheath, which are not shown in the figures, may be related guide wires and guide sheaths of the prior art that guide the vascular balloon into the body, as they are not inventive places, are known in connection with the description and prior art, and therefore do not give a specific illustration nor affect the understanding of the overall solution.

The above description of embodiments is only for the understanding of the present utility model. It should be noted that it will be apparent to those skilled in the art that modifications can be made to the present utility model without departing from the principles of the utility model, and such modifications will fall within the scope of the claims.

Claims

1. A puncture-implanted radiotherapy tissue isolation device capable of being repeatedly filled and discharged in a body, which comprises,

the isolation saccule is used for isolating normal tissues and radiotherapy tissues; the charging device comprises two contact surfaces, namely a first contact surface and a second contact surface; the first contact surface contacts normal tissues needing to be isolated, and the second contact surface contacts tissues receiving radiotherapy; the minimum distance between the first contact surface and the second contact surface is not less than the distance required by the radiation dose to drop to the tolerable dose of normal tissues; it is characterized in that the utility model also comprises,

the soft connecting pipe is defined to enter the inner end of the body first as a first end; the first end of the soft connecting pipe is arranged in the isolation balloon or extends out from the first end of the isolation balloon, and a filling pipeline for filling the isolation balloon is arranged in the soft connecting pipe;

the soft connecting pipe also comprises a positioning pipeline, and the positioning pipeline is internally provided with a supporting and positioning structure for adjusting the position and the angle of the isolation balloon.

2. The spacer of claim 1, wherein the support positioning structure is a rigid support bar.

3. The isolation device of claim 1, wherein the positioning pipeline is a non-circular pipeline, and the support positioning structure is adapted to the non-circular positioning pipeline and is used for driving the flexible connecting pipe and the isolation balloon to axially rotate in the body by rotating the support positioning structure.

4. An isolation device according to claim 3, wherein the positioning pipeline is provided as a square pipeline or a semicircular pipeline; alternatively, the positioning conduit is provided as a conduit with at least one plane.

5. The isolation device of claim 1, wherein the charging line is disposed in parallel with the positioning line; the charging pipeline and the positioning pipeline are integrated in a unified soft connecting pipe.

6. The isolation device of claim 5, wherein the charging line and the positioning line are two separate lines within a complete flexible connection tube; and the filling pipeline and the positioning pipeline are equally divided into a flexible connecting pipe cavity.

7. The isolation device of claim 1, wherein the flexible connecting tube penetrates the isolation balloon and extends out of the first end of the isolation balloon, and a filling through hole communicated with the isolation balloon is arranged on the side wall of the filling pipeline; extension tubes are arranged at two ends of the isolation balloon and are in sealing connection with the flexible connecting tube.

8. The isolation device of claim 1, wherein the flexible connecting tube is closed at a first end; the positioning pipeline is not communicated with the isolation balloon.

9. The isolation device of claim 1, wherein the first contact surface and the second contact surface are in the same plane, and wherein the projections of the first contact surface and the second contact surface at the horizontal plane overlap.

10. The isolation device of claim 1, wherein the isolation balloon is provided with a drug-loaded coating, wherein the first contact surface is provided with a drug coating carrying a radioprotectant and/or a slow release local anesthetic but not a chemotherapeutic drug; the second contact surface is provided with a drug coating carrying a chemotherapeutic drug and/or a slow-release local anesthetic but not carrying a radioprotectant.