CN109925592B

CN109925592B - Catheter device and brachytherapy system

Info

Publication number: CN109925592B
Application number: CN201711346758.0A
Authority: CN
Inventors: 杨凯琳; 王暄棉; 张维哲; 周正堉; 赖宗佑; 陈明正
Original assignee: Braxx Biotech Co ltd
Current assignee: Braxx Biotech Co ltd
Priority date: 2017-12-15
Filing date: 2017-12-15
Publication date: 2022-02-01
Anticipated expiration: 2037-12-15
Also published as: CN109925592A

Abstract

The present invention provides a catheter device comprising: a multi-lumen tubing structure integrally formed having a proximal direction and a distal direction, wherein the multi-lumen tubing structure comprises a tubular structure and a plurality of fluid flow tube structures, the tubular structure and the plurality of fluid flow tube structures being arranged along a first axial direction of the multi-lumen tubing structure; at least one cuff membrane element covering an outer edge of the multi-lumen tubing structure, wherein the at least one cuff membrane element comprises a reinforcement structure and/or a cushioning structure; and a tip engaged to the multi-lumen tubing structure to securely affix the tip to the multi-lumen tubing structure. The invention also provides a proximity treatment system adopting the catheter device, which can be used for treating esophageal cancer and other intraluminal tumors.

Description

Catheter device and brachytherapy system

Technical Field

The present invention relates to a catheter device for brachytherapy, and more particularly, to an esophageal cancer brachytherapy catheter device and an esophageal cancer brachytherapy system having a reinforcing structure and/or a buffering structure.

Background

The brachythermy is a radiation therapy method for tumor in body cavity, and is characterized by that it utilizes the catheter to enter body cavity or organ, places the catheter at or near the periphery of tumor tissue, and utilizes the after-loading therapeutic equipment to introduce radioactive source into the catheter to make the radioactive source stay in the tumor region, and uses the light wave or high-speed particle type radiation to destroy tumor cell and inhibit the growth of tumor cell.

Esophageal cancer (esophageal cancer) is a malignant tumor of the esophagus. In the course of treating esophageal cancer by the brachytherapy technique, as the radiation dose is accumulated, the side effects are also obviously shown, such as: radiation pneumonitis, Radiation esophagitis, or acute esophageal hemorrhage, which are related to The irradiated site and dose of Radiation therapy, The intensity of The Radiation source decreases inversely with The square of The distance, and The absorbed dose is higher and The side effects are greater for normal tissues closer to The Radiation source, as shown in FIG. 1(Hitoshi Ikushima, Radiation therapy: state of The art and The future, The Journal of Medical Investigation volume.57february 2010). In addition, brachytherapy is a procedure that requires consistency and reproducibility over several treatments, requiring precise positioning to ensure that the tumor receives a consistent therapeutic dose per procedure. Because internal displacements (internal displacements) of organs in The body (such as The thoracic cavity, which is caused by The movement of The diaphragm during breathing, move The internal organs inside The thoracic cavity), if The Radiation source and The tumor are not fixed precisely, The normal tissue will be subjected to a higher Radiation dose, which makes The Radiation treatment inaccurate, as shown in fig. 2 (high ikushi surgery, Radiation therapy: state of The art and The future, The Journal of Medical Investigation volume.57february 2010).

Therefore, the biggest difficulty in clinical personalized medicine is that the body cavity/organ and tumor size of each patient are different, and it is difficult to provide the optimal treatment dose according to the condition of normal tissue, tumor and radioactive source of each patient; in addition, at present, nasogastric tubes are mostly used for treatment clinically, the diameter of the nasogastric tubes is thin, the fixing effect is poor, the radiation sources cannot be placed in the esophagus cavity, high radiation treatment dosage needs to be introduced for esophageal cancer brachytherapy, when the nasogastric tubes are attached to the esophageal wall randomly, the distance between the radiation sources and the normal esophageal wall is too short, the radiation dosage is easily too high, radiation hot spots are generated, serious side effects are caused, and the use intention of doctors is influenced; the existing catheter for esophageal cancer brachytherapy is put into the oral cavity of a patient and enters the esophagus through the throat, so that the patient is easy to feel uncomfortable.

For example, the Bonvoisin-Gerard Espohageal Applicator product of Elekta, distracts the body cavity with the full length of the overthickness catheter, and places the radiation source within the overthickness catheter. However, since the dose of the radiation source is inversely proportional to the square of the distance, when the tumor grows on the superficial area, more normal tissue areas are irradiated, which easily causes side effects, and meanwhile, the dose planning of the radiation therapy is also affected by indiscriminate dilation of the whole esophagus, and the optimal dose compliance cannot be provided; in the case of a large tumor with a narrow esophagus, the wall of the enlarged catheter may be abraded to bleed. In addition, the thickened catheter uses a whole thickened section of tube without fluctuation, which easily causes the catheter to slide in a peristalsis smooth esophagus, and the fixing effect is not good.

Taking the catheter of chinese patent publication No. CN202387089U as an example, the catheter has a catheter body, a developing ring, at least two balloons, a balloon cavity, a balloon filling channel, a balloon injection port, a guide wire (guide wire) channel, and a guide wire channel injection port. The sacculus diameter is the same, the shape is long cylindricality, fills earlier terminal sacculus during treatment, fills adjacent sacculus in proper order on this basis to on the basis of terminal sacculus expansion, can directly prolong the whole length of sacculus without changing the sacculus pipe, can be the tumour of fixed length more than 3 centimeters. However, if the balloon is an externally applied long cylindrical balloon, and the inflation amount is not up to the standard for providing the balloon with supporting force, the balloon may not be uniformly inflated, and the radiation source may not be centered in the catheter, which may result in the reduction of the reproducibility of the treatment plan. In addition, the catheter requires a guide wire for auxiliary treatment, increasing the operational procedures.

To avoid serious side effects, American Brachytherapy Society proposes: the diameter of the tube for brachytherapy should be at least 10 mm. The Elekta and Varian company also developed such treatment tubes of increased diameter. Clinically, the operation of a gastrointestinal physician needs to be matched, the thickened tube is guided from the mouth by a guide wire and is placed into a body cavity under the assistance of an endoscope, the method not only increases working procedures due to the placement of the guide wire, but also changes the position of a catheter due to vomiting reflex or swallowing reaction easily caused by the placement of the guide wire from the oral cavity to cause discomfort of a patient, so a sedative or anesthesia needs to be applied, the patient also needs to lie on the side, when tumor image data is obtained, a treatment plan of the patient is determined (the stay position and the stay time of a radiation source is determined), and then the patient is moved to a hospital bed to be ready to receive the brachytherapy, as long as the curvature of the side lying of the patient is changed, the applicability of the treatment plan of the physician is reduced, the treatment is not accurate, and the inconvenience and the risk in operation are increased.

Further, the applicator of U.S. patent publication No. US20170173362a1 has a distal balloon, a proximal balloon, and an independently inflatable intermediate balloon disposed between the distal and proximal balloons. The applicator is an independently inflatable balloon to prevent radiation doses from being applied to healthy tissue areas adjacent to the patient's tumor, reducing side effects. However, the applicator does not solve the problem of bleeding from the wound due to uneven inflation of the balloon, radiation hot spots generated by sources offset from the center of the esophagus; in addition, the placing device still uses the guide lumen and the tip to apply auxiliary tools such as a guide wire and the like to enable the placing device to enter the esophagus of a patient, the problem of the working procedure of placing the guide wire is not solved, and the use intention of medical personnel cannot be improved.

To save operating time for specialists such as gastroenterology, U.S. patent publication No. US20100185173A1 proposes a similarly flexible catheter having a medical balloon catheter, two inflatable balloons and a removable inner catheter, which allows a non-specialist to insert the deflated medical balloon catheter into the patient's esophagus through the nose and throat, position the inflatable balloons in the treatment area, and introduce a radiation source. However, the catheter does not solve the problem that the balloon is not inflated enough to cause the radiation source to deviate from the center of the esophagus to generate radiation hot spots to cause wound bleeding; in addition, the balloon, if inflated to a certain volume and not having sufficient support to support the esophageal wall, cannot provide the optimal therapeutic dose according to the normal tissue, tumor and radiation source conditions of each patient.

Chinese patent publication No. CN2345224Y proposes an esophageal intraluminal therapeutic catheter having a suction lumen, a liquid medicine dripping lumen, two balloon inflation lumens, two balloons and a closed solid blunt cone head. This pipe is inserted the esophagus by the nasal cavity after, is blocked in tumour both ends with two expanded gasbags to attract the chamber to take out saliva, drops into the chamber with the liquid medicine and drops into chemotherapy medicine or immunotherapy medicine, and the pipe length is then 100 ~ 150mm, in order to ensure that sufficient liquid medicine stays the space, reduces the side effect. However, the catheter needs to be applied with a nose bridge fixing frame to prevent the catheter from sliding in the esophagus, i.e. the catheter may not have enough supporting force to support the esophageal wall, and also cannot provide the optimal treatment dose for the tumor, normal tissue and radiation source in the brachytherapy; when diffuse tumors are treated, the risk of bleeding caused by friction between the saccule and the tumors can be generated; moreover, the conical head may fall off from the esophagus during the operation to cause injury to the human body.

The existing catheter has the defects, so how to design a catheter which can provide high therapeutic dose to kill tumor cells and reduce the recurrence rate without changing the using habit of doctors; normal tissues are protected, so that the generation of radiation hot spots during brachytherapy is avoided, and side effects are reduced; the problem to be solved is that the catheter device does not need to be assisted by a guide wire, does not need to be operated for many times under the condition of a plurality of tumors or diffuse tumors, and does not cause the displacement of the catheter device in the esophagus due to the movement of a patient, thereby saving the energy of a doctor and relieving the discomfort of the patient.

Disclosure of Invention

The present invention provides a catheter device comprising: a multi-lumen tubing structure integrally formed having a proximal direction and a distal direction, wherein the multi-lumen tubing structure comprises a tubular structure and a plurality of fluid flow tube structures, the tubular structure and the plurality of fluid flow tube structures being arranged along a first axial direction of the multi-lumen tubing structure; at least one cuff membrane element covering an outer edge of the multi-lumen tubing structure, wherein the at least one cuff membrane element comprises a reinforcement structure and/or a cushioning structure; and a tip engaged to the multi-lumen tubing structure to securely affix the tip to the multi-lumen tubing structure.

Preferably, a plurality of outer ring elements are arranged on the outer edges of the pipe sleeve membrane elements; the plurality of outer ring elements are used for enabling the pipe sleeve membrane elements to be tightly buckled on the multi-pipe pipeline structure to form a plurality of pipe sleeve membrane structures.

Preferably, the cover membrane structure is a cylindrical or a waist drum surrounding the multi-lumen tube.

Preferably, the film covering structure has a film thickness, a central section and two side sections, and the film thickness decreases from the central section to the two side sections.

Preferably, the number of the tube sleeve membrane elements is more than one; the number of the fluid flow pipe structures is more than three; the number of the film covering structures is more than three.

Preferably, the tip and the multi-lumen tubing structure are integrally formed.

Preferably, the tip is a cone or a truncated cone engaged with the multi-lumen tubing structure.

Preferably, the tip is a closed structure, and the tip further includes a material capable of absorbing radiation.

Preferably, the tip includes a primary engagement structure for securing to a secondary engagement structure of the multi-lumen tubing structure.

Preferably, the primary engaging structure and the secondary engaging structure are a tenon, a buckle, or a screw structure corresponding to each other.

Preferably, the reinforcing structures are provided inside or outside the membrane sheathing elements so that the membrane sheathing structures each expand uniformly at a constant velocity from the axis toward the periphery in the radial direction.

Preferably, the reinforcing structure is at least one strip or a plurality of dots distributed on the cover film structure.

Preferably, the strip-shaped structures may be formed in a symmetrical, a parallel, a staggered and/or a discontinuous structure.

Preferably, the buffering structure is a recess, a protrusion or a fold disposed on the outer side of the membrane sheathing element, so that the membrane sheathing structure can release pressure uniformly during the initial expansion.

Preferably, the plurality of fluid flow tube structures have a control element in the proximal direction, the control element is used for independently expanding and contracting the sleeve membrane structures connected in the distal direction of the fluid flow tube structures.

Preferably, the plurality of fluid flow tube structures have a plurality of control elements in the proximal direction, the plurality of control elements each being independently disposed in the proximal direction of the plurality of fluid flow tube structures; the control element is used for enabling the sleeve membrane structures connected with the far end direction of the fluid flow pipe structure to independently expand and contract.

Preferably, each of the plurality of fluid flow tube structures further has an independent communicating structure, which is respectively communicated with the positions of the different membrane covering structures, so that the different fluid flow tubes can deliver the fluid to the different membrane covering structures through the respective independent communicating structures.

Preferably, the independent communication structure may be a pipe or an opening.

The invention also provides a proximity therapy system, which comprises a rear-loading type therapeutic apparatus; the catheter device is connected to the rear-loading type therapeutic apparatus; and a radiation therapy source emitted by the afterload therapy device into the tubular structure of the catheter device.

Preferably, there is a tumor imaging device, and the afterload apparatus determines the position of the covering membrane structure for delivering the radiation therapy source to the tubular structure according to the tumor imaging device.

Preferably, the tumor imaging apparatus includes, but is not limited to, X-ray imaging, fluoroscopy, computed tomography, positron emission tomography, single photon emission tomography, and magnetic resonance imaging.

Preferably, the brachytherapy system is used to treat esophageal cancer and other intraluminal tumors.

Drawings

FIG. 1 is a graph of dose versus tissue toxicity for radiation therapy.

FIG. 2 is a schematic diagram of the radiation range and displacement deviation during external radiotherapy.

Fig. 3 is a schematic structural diagram of an embodiment of the catheter device of the present disclosure.

Fig. 4 is a schematic cross-sectional view a-a of an embodiment of the catheter device of the present disclosure.

Fig. 5 is a schematic structural diagram of an embodiment of the catheter device.

Fig. 6(a) is a schematic structural diagram of an embodiment of the film covering structure of the present disclosure.

Fig. 6(b) is a schematic structural diagram of an embodiment of the film covering structure of the present disclosure.

Fig. 6(c) is a schematic side view of an embodiment of the film-covering structure of the present disclosure.

Fig. 7 is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 8 is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 9(a) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 9(b) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 9(c) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 10(a) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 10(b) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 11(a) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 11(b) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 12(a) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 12(b) is a schematic structural diagram of an embodiment of the present reinforcing structure.

Fig. 13(a) is a schematic structural diagram of an embodiment of the reinforcing structure and the buffer structure of the present disclosure.

Fig. 13(b) is a schematic structural diagram of an embodiment of the reinforcing structure and the buffering structure of the present disclosure.

FIG. 13(c) is a schematic cross-sectional view B-B of an embodiment of the present reinforcing structure.

Fig. 14(a) is a schematic structural diagram of an embodiment of the reinforcing structure and the buffer structure of the present disclosure.

Fig. 14(b) is a schematic structural diagram of an embodiment of the reinforcing structure and the buffer structure of the present disclosure.

FIG. 14(C) is a schematic cross-sectional view of a reinforcement structure according to an embodiment of the present disclosure.

Fig. 15(a) is a schematic structural diagram of an embodiment of the reinforcing structure and the buffer structure of the present disclosure.

Fig. 15(b) is a schematic structural diagram of an embodiment of the reinforcing structure and the buffer structure of the present disclosure.

FIG. 15(c) is a schematic cross-sectional view of an embodiment of the present reinforcing structure in a cross-sectional view D-D.

Fig. 16(a) is a schematic side view of an embodiment of the present cushioning structure before inflation.

Fig. 16(b) is a schematic side view of an embodiment of the present cushioning structure after expansion.

Fig. 16(c) is a schematic perspective view of an expanded embodiment of the present cushioning structure.

Fig. 17(a) is a schematic side view of an embodiment of the present cushioning structure before inflation.

Fig. 17(b) is a schematic side view of an embodiment of the present cushioning structure after expansion.

Fig. 17(c) is a schematic perspective view of an expanded embodiment of the present cushioning structure.

Fig. 18 is a schematic view of the independent expansion of the film structures.

Fig. 19 is a schematic view of the respective independent expansion and contraction of the mantle structures of the catheter device to control size of the compliant tumor.

Detailed Description

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

The present invention will be described in terms of the following embodiments, which will be apparent to those skilled in the art and can be accomplished by the following embodiments.

The embodiments of the present invention are not limited by the following examples.

Fig. 3 is a schematic structural view of an embodiment of a catheter device 1, and fig. 4 is a schematic cross-sectional view a-a of an embodiment of a multi-lumen tubing structure 2 of the catheter device.

The catheter apparatus 1 has an integrally formed multi-lumen tubing structure 2, the multi-lumen tubing structure 2 comprising a tubular structure 21 and a plurality of fluid flow tube structures 22. The tubular structure 21 is arranged along a first axial direction of the multi-lumen tubing set 2, in the middle of the catheter device 1, for placement of the source of radiation 25; the plurality of fluid flow tube structures 22 are disposed along the first axial direction of the multi-lumen tubing structure 2 and distributed around the tubular structure 21 (in the present embodiment, the "first axial direction" is a direction in which the long side of the catheter device is the axis). At least one tube-covering membrane element 3 covers the outer edge of the multi-lumen tubular structure 2, a plurality of outer ring elements 5 are disposed on the outer edge of the tube-covering membrane element 3, and the tube-covering membrane element 3 is tightly fastened to the multi-lumen tubular structure 2 to form a plurality of film-covering structures 32. The inside or outside of the shroud membrane element 3 may have a reinforcement structure 31 and/or a cushion structure 35 (see fig. 13). The plurality of fluid flow tube structures 22 are of the same length in the multi-lumen tubing structure 2, each having an independent communication structure 24 in the distal direction 11 thereof, and an independent control element 6 in the proximal direction 12 thereof. Different control elements 6 respectively send fluid (not shown) into the fluid flow tube structures 22, the fluid can flow to the distal direction 11 to the ends of the fluid flow tube structures 22, and meanwhile, the fluid can be filled into the spaces inside different film covering structures 32 through different independent communication structures 24 arranged midway in the fluid flow tube structures 22, so that the film covering structures 32 expand and contract, and the positioning effect is achieved. Because the different independent communication structures 24 are respectively arranged at the positions of the different sheathing structures 32, the different fluid flow pipe structures 22 transmit fluid to the different sheathing structures 32 through the respective independent communication structures 24, so that the respective expansion and contraction of the sheathing structures 32 and the respective expansion and contraction degree regulation and control are achieved. The tip 4, disposed in a distal direction 11 of the multi-lumen tubing structure 2, is inter-engaged with the multi-lumen tubing structure 2.

In some embodiments, the tip 4 has a primary engagement structure 41 and the multi-lumen tubing path structure 2 has a secondary engagement structure 23 in the distal direction 11, the primary engagement structure 41 and the secondary engagement structure 23 stably engaging the tip 4 with the multi-lumen tubing path structure 2 to securely hold the tip 4 to the multi-lumen tubing path structure 2 without being easily dislodged. In other embodiments, the primary engagement structure 41 of the tip 4 and the secondary engagement structure 23 of the multi-lumen tubing structure 2 may be a corresponding latch, snap, twist or twist structure to resist pushing, pulling or external forces from all directions to prevent the tip from falling off during the treatment. In some embodiments, the tip 4 may comprise a material that absorbs radiation for confirming the position of the catheter device 1 within the human body.

In some embodiments, the control element 6 may be a medical pump, syringe-type device, or the like. In other embodiments, the control element 6 may be a one-way valve or a two-way valve.

In some embodiments, the plurality of fluid flow tube structures 22 may be connected to the plurality of fluid flow tube structures 22 by a single control element (not shown), such as a computer-controlled pumping device, that independently controls the membrane structure 32 connected to each distal end 11 through a valve.

Fig. 5 is a schematic structural diagram of another embodiment of the catheter device 1.

In some embodiments, a plurality of membrane sheathing elements 3 cover the outer edge of the integrally formed multi-lumen tubular structure 2, and in order to fix the membrane sheathing elements 3 to the outer edge of the multi-lumen tubular structure 2, two outer ring elements 5 are respectively disposed at both ends of each membrane sheathing element 3 at the outer edge thereof, and each membrane sheathing element 3 is fastened to the multi-lumen tubular structure 2, respectively, to form a plurality of membrane sheathing structures 32. In other embodiments, two envelope structures 32 may be formed by one envelope membrane element 3 covering the outer edge of the integrally formed multi-lumen tubing structure 2 and three outer ring elements 5 securing one envelope membrane element 3. In some embodiments, a plurality of the aforementioned cuff membrane elements 3 and/or one cuff membrane element 3 may be used in combination to form more than three cuff membrane structures 32.

In some embodiments, to make the multi-lumen tubing structure 2 and the cuff membrane element 3 completely airtight, an adhesive (not shown) may be used to assist the outer ring element 5 to tightly fasten the cuff membrane element 3 to the multi-lumen tubing structure 2 so as to smoothly expand and contract the plurality of cuff membrane structures 32. Alternatively, in other embodiments, in order to make the multi-lumen pipeline structure 2 and the cuff membrane element 3 completely airtight, the cuff membrane element 3 may be directly fixed to the outer edge of the multi-lumen pipeline structure 2 by an adhesive (not shown) without using the outer ring element 5, so as to smoothly expand and contract the plurality of cuff membrane structures 32.

In some embodiments, the fluid flow tube structures 22 vary in length within the multi-lumen tubing structure 2 such that different fluid flow tube structures 22 are each directly connected to different ones of the sheathing structures 32 to achieve respective expansion and contraction of the sheathing structures 32 and respective controlled expansion and contraction.

In some embodiments, the independent communication structure 24 may be a pipe or an opening.

In some embodiments, in other embodiments, the primary engagement structure 41 and the secondary engagement structure 23 may be formed by heat and pressure, such as by hot-staking, to further stabilize the engagement of the tip 4 with the multi-lumen tubing structure 2. In other embodiments, the tip 4 may be a closed structure such as a cone or a frustum, and the closed structure may be solid, hollow or filled in other manners. In some embodiments, the tip 4 and the multi-lumen tubing structure 2 may be integrally formed through different processes.

The integrally formed multi-lumen tube structure 2, the tube-sleeve membrane element 3 and the tip 4 are made of flexible and bendable materials, which may be silicone, latex, plastic (such as PVC, PU, PP, PE, PTFE, etc.), or other biocompatible materials or combinations thereof, so that the membrane structure 32 formed by fixing the tube-sleeve membrane element 3 can be inflated after filling. The tubular structure 21 and the fluid flow tube structure 22 of the multi-lumen tubing structure 2 can be designed to have different lengths and calibers according to different affected parts, and the mantle structure 32 can also be designed to have different distance lengths according to requirements.

In the embodiment for esophageal cancer, the length of the catheter device 1 can be designed to be 600-1500mm, and the preferred length is 120 mm; the outer diameter of the catheter device 1 can be designed to be 1.5-10mm, preferably 6 mm.

In the embodiment for esophageal cancer, the outer diameter of the tubular structure 21 can be designed to be 2-6mm, preferably 2.5 mm; the inner diameter may be 1-5mm, preferably 1.2-2.0mm, to allow placement of a white tube (not shown) that assists in placement of the radiation source.

In an embodiment for esophageal cancer, the fluid flow tube structure 22 is the same length as the tubular structure 21. The fluid flow tube structure 22 may have an internal diameter of between 0.2 and 3mm, preferably 0.7 mm. The distance between the center of the fluid flow tube structure 22 and the center of the tubular structure 21 is 0.6-3mm, preferably 1.8-1.9 mm.

In embodiments for esophageal cancer, the length of the membrane structure 32 may be 5-100mm, preferably 10-40mm, more preferably 30mm, and optionally expanded to a diameter of 30mm or less.

Fig. 6(a) and fig. 6(b) are respectively schematic structural diagrams of an embodiment of the present mantle structure 32, and fig. 6(c) is a schematic side view of an embodiment of the present mantle structure, wherein two sides of a tube-in-tube element 3 are respectively fastened by two outer ring elements 5 to form the mantle structure 32 surrounding the multi-lumen pipeline 2, wherein the mantle structure 32 may be a cylindrical or waist-drum structure. In some embodiments, the central segment 33 and the two side segments 34 of the film-covered structure 32 have respective film thicknesses, the film thickness of the central segment 33 may be X1, the film thicknesses of the two side segments 34 may be X2, and X2< X1. In other embodiments, the central block section 33 has different die thicknesses, which may decrease from the center to both sides, i.e., the center of the central block section 33 has a film thickness of X1 and both sides have a film thickness of X2. In certain embodiments, X2 ═ 1/10X 1.

Fig. 7 to 12 are schematic structural views of an embodiment of the reinforcing structure 31 of the present disclosure.

Please see fig. 7. In some embodiments, reinforcing structures 31 may be disposed on the inner or outer sides of film sheathing element 3, and when outer ring element 5 separates film sheathing element 3 into film sheathing structures 32 and fluid (not shown) is introduced to expand film sheathing structures 32, reinforcing structures 31 may be used to uniformly expand each film sheathing structure 32 from the axis along the radial direction at a constant velocity all around.

Referring to fig. 7, a schematic structural diagram of an embodiment of a reinforcement structure 31 in the present application, in some embodiments, the reinforcement structure 31 is uniformly disposed on the inner side or the outer side of a tube sleeve membrane element 3, when an outer ring element 5 divides the tube sleeve membrane element 3 into tube sleeve membrane structures 32, so that when the tube sleeve membrane structures 32 are inflated by a fluid (not shown), a single reinforcement structure 31 located in the center of each tube sleeve membrane structure 32 is inflated in the radial direction at a constant speed with respect to the axis of the catheter device 1, so as to maintain a central radiation source pipeline in the center of the esophagus, thereby ensuring that the radiation source pipeline is located in the center of the esophagus, and further reducing the generation of radiation hot spots.

Referring to fig. 8 to 12, schematic structural diagrams of an embodiment of the reinforcing structure 31 in the present disclosure are shown, wherein the reinforcing structures 31 distributed in the film covering structure 32 may be in a dot shape, a stripe shape, or other structures. In some embodiments, as shown in fig. 8, the dot-shaped reinforcing structures 31 are symmetrically distributed on the film covering structure 32. In other embodiments, as shown in fig. 9(a) to 9(c), the reinforcing structure 31 may be two or more strip-shaped structures, and is symmetrically distributed on the whole film covering structure 32 along the axis of the long side of the film covering structure 32, or may be distributed in the center or both sides of the film covering structure 32. In other embodiments, as shown in fig. 10(a), the reinforcing structures 31 may be more than one strip-shaped structures, and are symmetrically distributed in parallel on the whole film covering structure 32 along the axis of the short side of the film covering structure 32, or as shown in fig. 10(b), the reinforcing structures 31 are perpendicular to each other and symmetrically distributed in a staggered manner on the whole film covering structure 32. In other embodiments, as shown in fig. 11(a) to 11(b), the discontinuous reinforcing structures 31 are symmetrically distributed throughout the entire film covering structure 32. In some embodiments, as shown in fig. 12, the reinforcing structures 31 are distributed in a cross-symmetrical manner throughout the entire cover structure 32. In some embodiments, the symmetrical reinforcing structures 31 may help the film cover structure 32 expand uniformly.

In some embodiments, the inflated shape of the cover structure 32 may be spherical, cylindrical or other shapes (not shown). Since it is not necessary to define the expanded profile, it is also not necessary to define the base inflation of the envelope structure 32.

Fig. 13 to 15 are a schematic side structure view and a schematic cross-sectional view of an embodiment of the reinforcing structure 31 and the buffer structure 35 in the present disclosure.

Please refer to fig. 13 to 14, which illustrate the reinforcing structure 31. In some embodiments, the strip-shaped reinforcing structures 31 provided on the film sheathing element 3 may be geometric shapes such as rectangular columns or cylinders. Please refer to fig. 13 to 15, which illustrate the reinforcing structure 31. In other embodiments, the reinforcing structures 31 in the form of bars or dots have a height X3, and in some embodiments, X3 may be designed to be 0.01mm to 2mm, preferably 0.1 mm.

Please refer to fig. 13 to 15, which illustrate the buffer structure 35. In some embodiments, cushioning structures 35 are raised structures disposed on the outside of membrane sleeve element 3 and on either side of each membrane sleeve structure 32. In other embodiments, the buffer structures 35 can be recessed structures (not shown) disposed outside the membrane-sheathing elements 3 and located on both sides of each membrane-sheathing structure 32.

Fig. 16 to 17 are schematic structural diagrams of an embodiment of the buffer structure 35 in the present disclosure.

Fig. 16(a) is a schematic side view of an embodiment of the buffer structure 35 before expansion, in some embodiments, the buffer structure 35 is disposed outside the membrane-sheathing element 3 and on both sides of each membrane-sheathing structure 32, and before filling and expansion, both ends of the buffer structure 35 are respectively folded and flatly attached to the outer surface of the membrane-sheathing element 3; referring to fig. 16(b) and 16(c), in a side view and a perspective view of an embodiment of the present buffering structure 35 after expansion, in filling, based on the axial center of the duct device, the tension of the film covering structure 32 is released and expands in preference to the buffering structure 35, and the buffering structure 35 is folded and expanded along with both ends of the outer surface of the film covering element 3.

Fig. 17(a) is a schematic side view of an embodiment of the buffer structure before expansion, in some embodiments, the buffer structures 35 are disposed outside the membrane-sheathing element 3 and on both sides of each membrane-sheathing structure 32, and before filling expansion, one end of the buffer structure 35 is folded and flatly attached to the outer surface of the membrane-sheathing element 3; referring to fig. 16(b) and 16(c), in a schematic side view and a schematic perspective view of an embodiment of the present buffering structure after expansion, in filling, based on the axial center of the catheter device, the tension of the membrane covering structure 32 is released and expands in preference to the buffering structure 35, and the end of the buffering structure 35 folded and flatly attached to the outer surface of the membrane covering element 3 expands accordingly.

In some embodiments, when the fluid (not shown) is filled into the membrane covering structure 32 to expand, the structure design of the buffer structure 35, such as protrusion, recess or folding, is used to release the tension of the membrane covering structure 32 prior to the buffer structure 35 and expand, so that when the whole membrane covering structure 32 expands, the uniform distribution of the tension can be maintained with respect to the axis of the catheter device, thereby ensuring the consistency of the shape of the membrane covering structure 32 during and after the expansion.

Fig. 18 is a schematic view of the respective expansions of the present mantle structures 32. In the scheme, whether each sleeve membrane structure 32 is filled with fluid or the amount of the fluid filled in each sleeve membrane structure 32 can be independently controlled, so that the expansion and contraction degree of each sleeve membrane structure 32 can be independently controlled, and when the sizes of the tumors in different sections are different, a smaller amount of fluid can be filled in the narrow part of the body cavity (caused by larger or more protruded tumors) according to the actual requirement of the growth situation of the tumors in the body cavity of a patient, so that the sleeve membrane structures 32 can be expanded; when the tumor grows more superficial (the esophageal lumen is less narrow), more fluid is filled to expand the mantle structure 32, so as to achieve the purpose of killing the tumor with less radiation dose and reduce the side effect.

As shown in FIG. 19, after the catheter device 1 is connected to the afterload therapy apparatus 103, the catheter device 1 (omitting some components) can determine which of the mantle structures 32 need to be expanded or contracted and the size of the expanded or contracted according to the size and position of the tumor tissue 101 in the body cavity, and then the incident source 25 is placed for performing the brachytherapy. Because the mantle structure 32 of the catheter device 1 can be uniformly expanded and contracted, the axis of the catheter device 1 is centered in the esophagus, and when a treatment plan is arranged for a patient, the radiation source can be ensured to be positioned in the center of the esophagus, and the generation of radiation hot spots is avoided.

The position and the size of the swelling and shrinking of the mantle structure 32 are determined according to an image taken by the tumor imaging apparatus 104, and the tumor imaging apparatus 104 includes X-ray imaging, fluoroscope (fluoroscope), computed tomography (CT Scan), Positron Emission Tomography (PET), single photon emission tomography (SPECT), Magnetic Resonance Imaging (MRI), and the like.

The following are the application steps in the embodiment of the present invention for esophageal cancer, which are helpful to those skilled in the art to understand the possible application modes of the present invention and replace other application steps to apply the present invention without departing from the scope of the present application:

the catheter device 1 is placed into the esophagus from the nasal cavity. In the state where the covering structure 32 is not yet expanded or contracted, the catheter device 1 is smoothly passed from the nasal cavity to the esophagus without being inserted from the oral cavity. After the catheter device 1 is placed in the esophagus, it is fixed outside the nostril by sticking the adhesive tape.

The white tube (not shown) is inserted into the tubular structure 21 of the catheter device 1 to the extreme end, and the white tube (not shown) is adhered and fixed to the tubular structure 21 by an adhesive tape.

The open end of the white tube (not shown) is connected to a rear-loading therapeutic apparatus 103, and a simulated radiation source capable of measuring the relative depth of the esophageal cavity and developing in the CT image is placed.

Capturing a reconstructed planar image (scout view) of the patient's part image, viewing the distribution range of the simulated radiation source, and determining the position and degree of expansion of the corresponding expanded envelope structure 32 of the catheter device 1 in comparison with the tumor range of the reconstructed planar image of the computerized tomography image of the treatment planning system.

After the partial envelope structure 32 is expanded, the computed tomography image is scanned, the expansion is confirmed to be appropriate, and if necessary, the computer tomography image is rescanned after modification.

The computed tomography image is transmitted to the treatment planning system to map the tumor location and tumor extent when the mantle structure 32 is inflated, and also to map its surrounding normal tissues (e.g., lung, heart, spinal cord, etc.).

A 3D treatment plan (dose calculation) is made for various tumor sizes and shapes of patients to ensure that the tumor volume receives sufficient dose and that the received dose of normal tissue is within safe limits.

The treatment is performed, giving irradiation.

With nasogastric tube brachytherapy of the prior art, or with conventional techniques (e.g. Elekta

Bonvoisin-Gerard Esophageal Applicator product, U.S. patent publication No

US20170173362A1, US20100185173A1, Chinese patent publication No

CN2345224Y, etc.), the catheter device 1 of the present invention can make a plurality of independent membrane covering structures 32 uniformly expand from the axis center to the periphery at a constant speed along the radiation direction under the condition of independently controlling whether to fill fluid and the respective filling volume due to the reinforced structure 31 or the membrane thickness design of the membrane covering elements 3, so as to keep the axis center of the catheter device 1 in the esophagus and make the radiation source introduced into the tubular structure 21 in the center of the esophagus, thereby improving the problem of radiation hot spot caused by the deviation of the introduced radiation source due to the failure of the axis center of the catheter in the prior art. Compared with the prior art, the design of the film covering structure 32 of the catheter device 1 can be matched with the size of the esophagus of a patient without limiting the basic inflation quantity, and the catheter device has enough supporting force in the esophagus by any liquid filling quantity; the catheter device 1 can avoid the situation that the catheter slides in the esophagus due to the posture change of a patient or the peristaltic influence of the esophagus without additionally applying an external fixing frame. In addition, due to the design of the tip 4, the catheter device 1 can enter the esophagus from the nasal cavity through the throat without using auxiliary tools (such as an endoscope, a guide wire and the like), so that the discomfort of a patient is reduced, and the problem that the tip falls into the body of the patient in the process of proximity treatment can be avoided; in addition, the whole outer diameter of the catheter device 1 before filling and expansion is less than 10mm, compared with the prior art, the catheter device can not cause cavity wall damage or bleeding due to friction between the body cavity and the body cavity wall, and the smoothness of the catheter device when being placed in a narrow cavity of a patient is improved. Because the catheter device 1 is provided with enough mantle structures 32 (for example, 8 expansible mantle structures), even diffuse tumors do not need to move after the catheter device is placed, so that a patient can feel comfortable without anesthesia.

Under the condition of not changing the use habit of a doctor, the invention provides a method which does not need the assistance of a guide wire, does not drop the tip into the body, can irradiate the whole diffuse tumor section through one-time proximity treatment, does not need to repeatedly place a catheter and a radiation source, avoids the change of the relative position between the catheter and the tumor caused by the respiration or movement of a patient, saves the energy of the doctor and improves the treatment planning precision; the tension is uniformly distributed by the design of the strengthening structure and/or the buffering structure, so that the consistency of the form of the film covering structure in the expansion process and after the expansion is ensured; the present case need not put into and need not apply the anesthesia to the disease from the oral cavity when treating esophagus cancer, and the mantle structure that can expand and contract is different with the plus gasbag of general pipe, can not cause the patient discomfort or lead to the chamber wall to damage to bleed with the friction of body cavity wall when getting into the body cavity, more ensures that the source position of radiation is located esophagus central authorities, has avoided the brachytherapy side effect that the production of radiation hotspot leads to, has solved prior art's problem, has reached better effect.

Description of the symbols

1 catheter device

11 distal direction

12 proximal direction

2 multi-lumen pipeline structure

21 tubular structure

22 fluid flow tube structure

23-pair joint structure

24 independent communication structure

25 radiation source

3-pipe sleeve membrane element

31 reinforcing structure

32-film structure

33 center section

34 two side sections

35 buffer structure

4 point of the design

41 primary joining structure

5 outer ring element

6 control element

101 tumor tissue

102 normal tissue

103 rear-loading type therapeutic apparatus

104 tumor imaging instrument

Cross section A-A, B-B, C-C, D-D

X1, X2, X3 film thickness

GTV tumor size

Extent of CTV diffusion

ITV shift deviation Range

PTV treatment margin

Claims

1. A catheter device, comprising:

a multi-lumen tubing structure integrally formed having a proximal direction and a distal direction, wherein the multi-lumen tubing structure comprises a tubular structure and a plurality of fluid flow tube structures, the tubular structure and the plurality of fluid flow tube structures being arranged along a first axial direction of the multi-lumen tubing structure;

a plurality of cuff membrane elements covering an outer edge of the multi-lumen tubing structure;

a plurality of outer ring elements disposed on outer edges of the cuff membrane elements, the plurality of outer ring elements for tightly fastening the cuff membrane elements to the multi-lumen tubing structure to form a plurality of cuff membrane structures; and

a tip engaged to the multi-lumen tubing structure to securely affix the tip to the multi-lumen tubing structure;

wherein, the pipe sleeve membrane element is also provided with a buffer structure, or is also provided with a strengthening structure and a buffer structure; the reinforcing structures are arranged on the inner side or the outer side of the pipe sleeve membrane elements so that the pipe sleeve membrane structures respectively and uniformly expand from the axis to the periphery along the radiation direction; the buffer structures are arranged at two ends of the film covering structure, so that the tension of the film covering structure is released and expanded in preference to the buffer structures.

2. The catheter device of claim 1 wherein said cover structure is a cylindrical or a waisted drum-like structure surrounding said multi-lumen tubing.

3. The catheter device of claim 1 wherein said cover membrane structure has a membrane thickness, a central section and two side sections, said membrane thickness decreasing from said central section to said two side sections.

4. The catheter apparatus of claim 1 wherein the number of fluid flow tube structures is three or more; the number of the film covering structures is more than three.

5. The catheter apparatus of claim 1, wherein the tip is integrally formed with the multi-lumen tubing structure.

6. The catheter device of claim 1 wherein the tip is a cone that engages the multi-lumen tubing structure.

7. The catheter device of claim 6, wherein the tip is a frustroconical structure engaged to the multi-lumen tubing structure.

8. The catheter device of claim 1, wherein said tip is a closed structure, said tip further comprising a radiation absorbing material.

9. The catheter device of claim 1 wherein said tip includes a primary engagement structure for securing to a secondary engagement structure of said multi-lumen tubing structure.

10. The catheter device of claim 9, wherein the primary engagement structure and the secondary engagement structure are a corresponding latch, a snap, or a screw structure.

11. The catheter device of claim 1, wherein the stiffening structure is at least one strip or a plurality of dot-like structures distributed over the cover structure.

12. The catheter device of claim 11, wherein said strip structure is symmetrical about said axis.

13. The catheter device of claim 12, wherein the symmetrical configuration is a parallel symmetrical configuration or a staggered symmetrical configuration.

14. The catheter device of claim 12, wherein said strip-like structure is a discontinuous structure.

15. The catheter device of claim 1, wherein the buffer structure is a depression, a protrusion or a fold to provide uniform pressure relief of the cover structure during initial inflation.

16. The catheter device of claim 1 wherein said plurality of fluid flow tube structures have a control element in a proximal direction for independently expanding and contracting each of said sheathing structures attached to said fluid flow tube structures in a distal direction.

17. The catheter apparatus of claim 1 wherein the plurality of fluid flow tube structures have a plurality of control elements in a proximal direction, the plurality of control elements each independently disposed in the proximal direction of the plurality of fluid flow tube structures; the control element is used for enabling the sleeve membrane structures connected with the far end direction of the fluid flow pipe structure to independently expand and contract.

18. The catheter device of claim 1 wherein each of said plurality of fluid flow tube structures further comprises an independent communication structure communicating with a location of a different one of said cover membrane structures, such that a different one of said fluid flow tubes delivers fluid to a different one of said cover membrane structures through a respective one of said independent communication structures.

19. The catheter device of claim 18 wherein said independent communication structure is a conduit or an open structure.

20. A catheter device, comprising:

the pipe sleeve membrane element is provided with a strengthening structure, and the strengthening structure is arranged on the inner side or the outer side of the pipe sleeve membrane element so that the pipe sleeve membrane structures respectively and uniformly expand from the axis to the periphery along the radiation direction; and

the reinforcing structure is at least one strip or a plurality of point structures distributed on the film covering structure, the strip structure or the point structures have height, and the strip structure is in a symmetrical structure along the axis.

21. The catheter device of claim 20, wherein the symmetrical configuration is a parallel symmetrical configuration or a staggered symmetrical configuration.

22. The catheter device of claim 20, wherein said strip-like structure is a discontinuous structure.

23. A brachytherapy system, comprising:

a rear-loading type therapeutic apparatus;

a catheter device according to any one of claims 1 to 19 or a catheter device according to any one of claims 20 to 22 attached to said afterload therapy device; and

a radiation therapy source emitted by the afterload therapy device into the tubular structure of the catheter device.

24. The brachytherapy system of claim 23, further comprising a tumor imaging modality, wherein the afterloader determines the position of the mantle structure for delivering the radiation therapy source to the tubular structure based on the tumor imaging modality.

25. The brachytherapy system of claim 24, wherein the tumor imaging instrument is X-ray imaging, fluoroscopic, computed tomography, positron emission tomography, single photon emission tomography, or magnetic resonance imaging.

26. The brachytherapy system of any of claims 23-25, wherein the brachytherapy system is configured to treat esophageal cancer or other endoluminal tumors.