Implanted gel type auxiliary balloon catheter and use method thereof

Abstract

The invention relates to an implanted gel type auxiliary balloon catheter which comprises a catheter body, and the catheter body is a double-cavity tube. The front end of the balloon is provided with a forming cavity used for assisting gel filling. The use method of the implanted gel type auxiliary balloon catheter comprises the following steps: enabling the folded balloon catheter to enter between the prostate and the rectum through the sheath tube; the balloon is filled through the in-vitro liquid injection hole, gel is injected through the gel injection hole, the gel is assisted to be implanted between the prostate and the rectum, it is ensured that the prostate and the rectum have enough isolation height and range in the radiotherapy period, and the rectum is protected against radiation damage. A gel filling space is expanded between the prostate and the rectum by utilizing a balloon filling expansion principle, and the gel is fully and uniformly filled between the prostate and the rectum, so that the prostate and the rectum have enough isolation height and range after being filled with the gel, and a good and controllable isolation effect is achieved during radiotherapy.

Description

Technical Field

[0001] The present invention relates to the medical field, and in particular to an implantable gel-assisted balloon catheter and a use method thereof. Background Art

[0002] Prostate cancer is one of the major malignant tumors that threaten the health of Chinese men. Currently, radiotherapy is one of the main treatments for prostate cancer. Patients with prostate cancer at different stages can undergo radical radiotherapy, postoperative radiotherapy, or salvage radiotherapy. However, since the rectum is adjacent to the prostate, radiotherapy can easily cause varying degrees of radiation-induced rectal damage in patients, seriously reducing the quality of life of patients. In addition, there is no effective prevention solution in China, which also limits the application of radiotherapy in the field of prostate cancer treatment in China.

[0003] In order to solve this problem, people have found that the anterior wall of the rectum can be isolated to a position away from the prostate, thereby reducing radiation damage to the rectum and reducing the incidence of intestinal toxicity. For example, Boston Scientific SpaceOAR disposable absorbable isolation hydrogel and Huaxi Bio-cross-linked sodium hyaluronate, etc., sterile injection, absorbable polymer gel (hereinafter referred to as gel), which is injected between the prostate and the rectum to form a temporary space and reduce damage to the rectum. However, the irregular space formed by the expansion of gel or water alone cannot make the bundle gel gather into the required size and shape, resulting in uneven isolation distance between the prostate and the rectum, inaccurate isolation position, and insufficient isolation range, which makes the distance and position protection interval between the prostate and the rectum insufficient, and does not play a good protective role. Summary of the invention

[0004] The technical problem to be solved by the present invention is: to overcome the shortcomings of the prior art, to provide an implantable gel-assisted balloon catheter and a method for using the catheter, to solve the technical problem that the previous injection method of filling gel between the prostate and the rectum relies on the irregular space formed by the expansion of gel or water, resulting in uneven isolation distance between the prostate and the rectum, inaccurate isolation position, insufficient isolation range, and insufficient distance and position protection interval between the prostate and the rectum.

[0005] The technical solution adopted by the present invention to solve its technical problem is:

[0006] First aspect:

[0007] Provided is an implantable gel-assisted balloon catheter, comprising

[0008] The catheter is a double-lumen tube, one of which is a liquid injection hole and the other is a glue injection hole;

[0009] The balloon has a molding cavity for assisting gel filling at the front end thereof, the balloon is arranged at the front end of the catheter, the liquid injection hole outlet is communicated with the balloon lumen, and the glue injection hole outlet is communicated with the molding cavity.

[0010] Furthermore, the front end of the balloon is inverted toward the inside of the balloon, and then the outer wall of the front end of the balloon and the catheter are welded and sealed to form an inverted molding cavity at the front end of the balloon, and the catheter extends into the molding cavity.

[0011] Furthermore, the depth of the front end of the balloon entering the balloon invertedly accounts for 1 / 3 to 1 / 2 of the entire balloon.

[0012] Furthermore, the balloon is in a C-shaped structure as a whole, so that a C-shaped molding cavity is formed at the front end of the balloon.

[0013] Second aspect:

[0014] A method for using the above-mentioned implantable gel-assisted balloon catheter is provided: firstly, a passage leading to the rectum and prostate fascia gap is established in the perineum, and the folded balloon catheter is passed through the sheath tube into the space between the prostate and the rectum;

[0015] Under ultrasound or X-ray observation, the farthest end of the balloon should be at the prostate head. Fill the balloon through the injection hole outside the body, adjust the height of the balloon, and drive the balloon to adjust its position. After the balloon is filled and expanded, a gel-filled space is formed.

[0016] Inject gel through the injection hole, observe the shape and size of the gel after filling under ultrasound or X-ray, withdraw the balloon while injecting gel to fill the molding cavity until there is enough isolation space between the prostate and the rectum, deflate and withdraw the balloon, and suture the wound to ensure that the gel forms enough isolation space between the prostate and the rectum during radiotherapy to protect the rectum from radiation damage.

[0017] The beneficial effects of the present invention are:

[0018] Using the balloon filling and expansion principle, a gel-filled space is expanded between the prostate and the rectum, and the auxiliary gel is fully and evenly filled between the prostate and the rectum, ensuring that the prostate and the rectum have sufficient isolation height and range after gel filling, and have a good and controllable isolation effect during radiotherapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present invention is further described below in conjunction with the accompanying drawings.

[0020] Figure 1 This is a schematic diagram of the first implantation gel-assisted balloon catheter of the present invention;

[0021] Figure 2 This is a schematic diagram of a second implantation gel-assisted balloon catheter of the present invention;

[0022] Figure 3 It is a diagram of the use status of implanted gel-assisted balloon catheter;

[0023] Among them, 1. catheter, 2. balloon, 21. molding cavity. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] The present application provides an implantable gel-assisted balloon catheter, which is described in detail below. It should be noted that the description order of the following embodiments does not limit the preferred order of the embodiments of the present application. In the following embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, please refer to the relevant description of other embodiments.

[0026] In order to solve the defects caused by the injection method of filling gel between the prostate and the rectum in the past, the irregular space formed by the expansion of gel or water causes uneven isolation distance between the prostate and the rectum, inaccurate isolation position, insufficient isolation range, and insufficient distance and position protection interval between the prostate and the rectum, an embodiment of the present application provides an implantable gel-assisted balloon catheter. The following is a detailed description.

[0027] like Figure 1 and Figure 2 As shown, an implantable gel-assisted balloon catheter comprises

[0028] The catheter 1 is a double-lumen tube, one of which is a liquid injection hole and the other is a glue injection hole;

[0029] The balloon 2 has a molding cavity 21 for assisting gel molding at its front end. The balloon 2 is arranged at the front end of the catheter 1 . The liquid injection hole outlet is connected to the inner cavity of the balloon 2 , and the glue injection hole outlet is connected to the molding cavity 21 .

[0030] Specifically, as an optional implementation in this embodiment, Figure 1 As shown, the front end of the balloon 2 is inverted toward the inside of the balloon 2, and then the outer wall of the front end of the balloon 2 and the catheter 1 are welded and sealed to form an inverted molding cavity 21 at the front end of the balloon 2, and the catheter 1 extends into the molding cavity 21.

[0031] In this embodiment, the molding cavity 21 is obtained from the mounting structure between the front of the balloon 2 and the catheter 1. The molding cavity 21 in this embodiment is funnel-shaped. The funnel-shaped structure facilitates the shaping of the gel and obtains a higher support distance for the gel. The height of the balloon 2 is adjusted by adjusting the amount of liquid filled in vitro with the assistance of ultrasound or X-ray imaging. The width should be able to cover the entire protection range. The gel is injected into the space formed by the balloon 2 through the injection hole to shape the gel so that the gel evenly and comprehensively separates the prostate and the rectum by a sufficient space.

[0032] As a preferred embodiment of this embodiment, Figure 1 As shown, the depth of the front end of the balloon 2 entering the balloon 2 inverted accounts for 1 / 3 to 1 / 2 of the entire balloon 2.

[0033] Specifically, as another optional implementation in this embodiment, Figure 2 As shown, the balloon 2 is a C-shaped structure as a whole, so that a C-shaped molding cavity 21 is formed at the front end of the balloon 2.

[0034] When the balloon 2 is in the rectum, the molding cavity 21 is used to assist the gel in molding in the cavity space.

[0035] In this embodiment, the balloon 2 is directly formed into a C-shape to obtain the forming cavity 21 , and at this time, the front end of the catheter 1 is kept flush with the inner wall surface of the forming cavity 21 .

[0036] The width of the molding cavity 21 should be able to cover the prostate range, and glue is injected into the range supported by the balloon 2 through the glue injection hole. At the same time, the C-shaped structure can better assist gel filling, obtain a larger support distance, and more effectively protect the rectum.

[0037] The balloon catheter in this embodiment, through the molding cavity 21 obtained at the front end of the balloon 2, can provide a filling space for gel molding through the molding cavity 21 when the rectum and the prostate are expanded, and assist the gel to be fully and evenly filled between the prostate and the rectum, ensuring that the prostate and the rectum have sufficient isolation height and range after the gel is filled, and have a good and controllable isolation effect during radiotherapy.

[0038] Method of using the above-mentioned implantable gel-assisted balloon catheter:

[0039] Use auxiliary instruments such as puncture needles and sheaths to first establish a passage leading to the rectum and prostate fascia gap in the perineum, and insert the folded balloon catheter through the sheath into the space between the prostate and the rectum;

[0040] Under ultrasound or X-ray observation, the farthest end of the balloon 2 should be at the prostate head, and the balloon 2 is filled through the injection hole outside the body, and the height of the balloon 2 is adjusted to drive the balloon 2 to adjust its position, and a molding cavity 21 is formed after the balloon is filled and expanded;

[0041] The gel is injected through the injection hole, and the shape of the gel aggregation is observed under ultrasound or X-ray. The balloon 2 is withdrawn while the gel is injected to fill the molding cavity 21 until the prostate and the support are completely blocked, and the balloon 2 is withdrawn to suture the wound to assist the gel in molding between the prostate and the rectum, ensuring that the gel forms sufficient isolation space between the prostate and the rectum during radiotherapy to protect the rectum from radiation damage.

[0042] The balloon dilation principle is used to pre-open a shapeable gel-filled space between the prostate and the rectum. The gel is injected while the balloon 2 is slowly withdrawn, so that the gel is injected into the space formed in the middle, thereby isolating the prostate and the rectum evenly, accurately and comprehensively, and providing better protection during prostate radiotherapy.

[0043] The gel mentioned in this embodiment is a cross-linked sodium hyaluronate gel or other polymer gel used for isolation and protection of close-range radiotherapy, and this gel is an existing product.

[0044] The various devices selected in this application (components whose specific structures are not described) are all universal standard parts or components known to technical personnel in this field, and their structures and principles can be known to technical personnel through technical manuals or through conventional experimental methods.

[0045] In the description of the embodiments of the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0046] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0047] In the several embodiments provided in the present application, it should be understood that the disclosed systems, devices and methods can be implemented in other ways. The device embodiments described above are merely schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some communication interfaces, and the indirect coupling or communication connection of devices or units can be electrical, mechanical or other forms.

[0048] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0049] In addition, each functional unit in each embodiment of the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.

[0050] Based on the above ideal embodiments of the present invention, the relevant staff can make various changes and modifications without departing from the technical concept of the present invention through the above description. The technical scope of the present invention is not limited to the contents of the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. An implantable gel-assisted balloon catheter, characterized in that: include A catheter (1), wherein the catheter (1) is a double-lumen tube, one of which is a liquid injection hole and the other is a glue injection hole; A balloon (2), wherein a molding cavity (21) for assisting gel filling is provided at the front end of the balloon (2), the balloon (2) is arranged at the front end of the catheter (1), the liquid injection hole outlet is communicated with the inner cavity of the balloon (2), and the glue injection hole outlet is communicated with the molding cavity (21).

2. The implantable gel-assisted balloon catheter according to claim 1, characterized in that: The front end of the balloon (2) is inverted toward the inside of the balloon (2), and then the outer wall of the front end of the balloon (2) and the catheter (1) are welded and sealed, so that the front end of the balloon (2) forms an inverted molding cavity (21), and the catheter (1) extends into the molding cavity (21).

3. The implantable gel-assisted balloon catheter according to claim 2, characterized in that: The depth to which the front end of the balloon (2) is inverted and enters the balloon (2) accounts for 1 / 3 to 1 / 2 of the entire balloon (2).

4. The implantable gel-assisted balloon catheter according to claim 1, characterized in that: The balloon (2) is of a C-shaped structure as a whole, so that a C-shaped molding cavity (21) is formed at the front end of the balloon (2).

5. A method for using the implantable gel-assisted balloon catheter according to any one of claims 1 to 4, characterized in that: First, establish a channel leading to the fascial space between the rectum and the prostate in the perineum, and insert the folded balloon catheter through the sheath into the space between the prostate and the rectum; Under ultrasound or X-ray observation, the farthest end of the balloon should be at the prostate head. Fill the balloon through the injection hole outside the body, adjust the height of the balloon, and drive the balloon to adjust its position. After the balloon is filled and expanded, a gel-filled space is formed. The gel is injected through the injection hole, and the shape and size of the gel after filling are observed under ultrasound or X-ray. The balloon is withdrawn while the gel is injected to fill the molding cavity (21) until there is enough isolation space between the prostate and the rectum. The balloon is deflated and withdrawn, and the wound is sutured. The auxiliary gel is fully and evenly filled between the prostate and the rectum to ensure that the gel forms a sufficient isolation space between the prostate and the rectum during radiotherapy to protect the rectum from radiation damage.

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