Post-mounting insertion needle fixing device and use method

Abstract

The invention relates to a post-installation implanting needle fixing device and a using method, the post-installation implanting needle fixing device comprises a base assembly used for stretching into a patient cavity and a positioning accessory located outside the patient cavity, the base assembly is detachably connected with the positioning accessory, and an implanting needle is installed on the base assembly and is subjected to stability maintaining and limiting by the base assembly; and the base assembly is stably limited by the positioning accessory. During use, the legs of a patient clamp the positioning accessory, and meanwhile the base assembly is limited. The position of the implantation needle can be determined in advance, multi-needle deformation, sagittal plane offset and spatial form change of the implantation needle caused by tissue extrusion and longitudinal displacement of the implantation needle caused by movement of a patient and connection of the implantation needle are reduced, and the relative position consistency of the patient from positioning to treatment is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of radiotherapy auxiliary tools, and in particular to a split-insertion post-installation implant needle fixing device and a use method thereof. Background Art

[0002] Afterloading therapy is a type of internal radiation therapy, usually used as a supplement to external radiation therapy, and is one of the main methods in modern brachytherapy.

[0003] Before afterloading therapy, one or more applicators (implantation needles) are placed in the tumor area, and then the radiation source is sent to the applicator (implantation needle) by a stepper motor through computer program control for treatment. Because this method is to place the applicator (implantation needle) in the patient's body in advance and then load the radiation source for treatment, it is called "afterloading therapy."

[0004] The general process of afterloading treatment is as follows: first, the applicator (implant needle) is inserted into the patient's body in the preparation room according to the treatment requirements, and then pushed to the CT simulation positioning machine for image scanning; during this period, the position of the applicator (implant needle) may need to be adjusted, and then the image is transmitted to the planning system to design a treatment plan. Finally, the patient is pushed into the machine room, the applicator (implant needle) is connected, and a special radiation device is used to implement the treatment according to the treatment plan.

[0005] Since tumors and their surrounding tissues are mostly soft tissues, the connection between the applicator (implantation needle) and the human body is a non-rigid connection. During the patient's movement from the preparation room to the simulation room and then to the treatment room, it is very easy to cause various deformations and displacements, thus causing treatment errors. Especially for multi-needle implants, it is difficult to get the desired needle placement results because of the soft tissues. Even if the placement is done well, it will still cause deformation and displacement due to long-term compression of the tissues, affecting the treatment effect. Summary of the invention

[0006] In view of the shortcomings of the above-mentioned existing production technology, the applicant provides a split-insertion post-installation implant needle fixing device with a reasonable structure and a use method to ensure the positioning accuracy of the implant needle.

[0007] The technical solution adopted by the present invention is as follows:

[0008] A split insertion type post-installation implant needle fixing device comprises a base component for probing into a patient's cavity, a hollow positioning auxiliary component located outside the patient's cavity,

[0009] The base assembly is detachably connected to the positioning auxiliary component.

[0010] The implant needle is installed on the base assembly and is stabilized and limited by the base assembly; the base assembly is stabilized and limited by the positioning auxiliary parts.

[0011] The positioning auxiliary component comprises a plate body, the middle of the plate body is hollowed out, and the outer contour of the plate body is a plurality of continuously connected inwardly concave arc edges.

[0012] As a further improvement of the above technical solution:

[0013] The base assembly comprises:

[0014] The fixing plate serves as a reference for installing the implant needle.

[0015] The sliding plate is coaxially arranged with the fixed plate and moves relative to the fixed plate; the fixed plate and the sliding plate are provided with a plurality of groups of coaxial through holes for accommodating the implant needles.

[0016] The slide bar connects the fixed plate and the slide plate, and one end of the slide bar away from the fixed plate is detachably connected to the positioning auxiliary component.

[0017] The slide bars are arranged in a circular array, and connecting pieces are provided between the slide bars.

[0018] The sliding plate slides back and forth between the connecting member and the fixed plate.

[0019] A locking operation length is reserved on the side of the connecting piece facing away from the fixing plate.

[0020] A lock is connected between the base assembly and the positioning auxiliary component, and the lock is locked to the end of the slide rod of the base assembly to apply a radial limiting force to the slide rod.

[0021] A positioning reference is arranged on the positioning auxiliary component, and the locking buckle abuts against a side of the positioning reference away from the base component.

[0022] An extension arm is slidably connected to the positioning auxiliary component.

[0023] A method for maintaining the stable position of an implant needle using a post-installed implant needle fixing device comprises the following steps:

[0024] The implant needle is pre-installed on the base assembly, and the base assembly limits the implant needle.

[0025] Insert the base assembly into the patient's cavity and push the implant needle until it reaches the desired position.

[0026] Install the base assembly onto the positioning aid, and use the lock buckle to lock the slide bar of the base assembly into position.

[0027] The patient's legs clamp the positioning aids and the relative position of the extension arm is adjusted according to the patient's body shape. At this time, the position of the implant needle is fixed, and when the patient is moved subsequently, the implant needle still maintains relative position accuracy.

[0028] As a further improvement of the above technical solution:

[0029] Before pre-installing the implant needle onto the base assembly, first slide the sliding plate close to the fixed plate, pass the implant needle through the sliding plate and the fixed plate at one time, and then move the sliding plate to the other end to complete the implant needle installation steps before inserting it into the cavity.

[0030] The beneficial effects of the present invention are as follows:

[0031] The present invention provides a structure for positioning an implant needle, which can predetermine the position of the implant needle, reduce multi-needle deformation caused by tissue compression, sagittal plane deviation of the implant needle, spatial morphology change, and longitudinal displacement of the implant needle caused by patient movement and implant needle connection, and ensure the relative position consistency of the patient from positioning to treatment.

[0032] The base assembly of the present invention is used to probe into the patient's cavity, so the base assembly is configured to be a cylindrical structure, and rounded corners are provided at the edges of the fixed plate and the sliding plate to facilitate insertion while preventing scratches on the patient's tissue; the fixed plate and the sliding plate are configured as plates with a certain thickness, which can reduce the pressure on the patient's tissue.

[0033] The reciprocating sliding of the sliding plate, on the one hand, can facilitate the insertion of the implant needle through the coaxial through holes on the sliding plate and the fixed plate, and on the other hand, can effectively limit the implant needle so that the implant needle is located at the specified position. During the subsequent movement of the patient, it is also reliably supported and is not easily displaced or deformed.

[0034] The positioning auxiliary of the present invention is used to provide a connection point for the base assembly, use a lock to limit all the sliding rods, and set a butterfly-shaped plate according to ergonomics to facilitate comfortable clamping of the patient's legs; the setting of the extension arm can adapt to patients of different body shapes. At the same time, because the extension arm is not a plate located in a certain plane, but a plate with a certain bending angle, it can better fit the human leg structure, so that when the patient is pushed into the medical environment, the positioning auxiliary can be used to limit the position of the implant needle in the base assembly to ensure the accuracy of treatment positioning.

[0035] Compared with the implant needle auxiliary device in the prior art, the main advantage of the present invention is that the implant needle is limited by the base assembly and the positioning auxiliary component at the same time, and the patient can easily clamp the positioning auxiliary component to ensure the position accuracy of the base assembly and the implant needle thereon. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 It is an exploded view of the overall structure of the present invention.

[0037] Figure 2 This is an exploded view of the overall structure of the present invention from another perspective.

[0038] Figure 3 This is an exploded view of the overall structure of the present invention from the reverse side.

[0039] Figure 4 It is a schematic diagram of the lock structure of the present invention.

[0040] Figure 5 It is a side view of the base assembly structure of the present invention.

[0041] Figure 6 It is a three-dimensional diagram of the base assembly structure of the present invention.

[0042] Among them: 1. Base assembly; 2. Positioning accessories; 3. Lock;

[0043] 101, fixed plate; 102, sliding plate; 103, sliding rod; 104, connecting piece;

[0044] 201. Plate body; 202. Positioning reference; 203. Extension arm; 204. Connecting section; 205. Extension section. DETAILED DESCRIPTION

[0045] The specific implementation of the present invention will be described below in conjunction with the accompanying drawings.

[0046] like Figure 1-Figure 6 As shown, the post-installation implant needle fixing device of this embodiment includes a base component 1 for inserting into the patient's cavity, and a positioning auxiliary component 2 located outside the patient's cavity.

[0047] The base assembly 1 is detachably connected to the positioning auxiliary component 2.

[0048] The implant needle is installed on the base assembly 1 and is stabilized and limited by the base assembly 1; the base assembly 1 is stabilized and limited by the positioning auxiliary component 2.

[0049] The base assembly 1 comprises:

[0050] The fixing plate 101 is used as a reference for installing the implant needle.

[0051] The sliding plate 102 is coaxially arranged with the fixed plate 101 and moves relative to the fixed plate 101; the fixed plate 101 and the sliding plate 102 are provided with a plurality of coaxial through holes for accommodating the implant needles.

[0052] The slide bar 103 connects the fixed plate 101 and the slide plate 102 , and one end of the slide bar 103 away from the fixed plate 101 is detachably connected to the positioning auxiliary component 2 .

[0053] The sliding bars 103 are arranged in a circular array, and connecting members 104 are provided between the sliding bars 103 .

[0054] The sliding plate 102 slides back and forth between the connecting member 104 and the fixed plate 101 .

[0055] A locking operation length is reserved on the side of the connecting member 104 facing away from the fixing plate 101 .

[0056] A lock buckle 3 is connected between the base assembly 1 and the positioning auxiliary component 2 . The lock buckle 3 is locked to the end of the slide rod 103 of the base assembly 1 to apply a radial limiting force to the slide rod 103 .

[0057] A positioning reference 202 is provided on the positioning auxiliary component 2 , and the lock buckle 3 abuts against a side of the positioning reference 202 away from the base assembly 1 .

[0058] An extension arm 203 is slidably connected to the positioning auxiliary component 2 .

[0059] The method of maintaining the position of the implant needle by using the post-installed implant needle fixing device of this embodiment includes the following steps:

[0060] The implant needle is pre-installed on the base assembly 1, and the base assembly 1 limits the position of the implant needle.

[0061] Insert the base assembly 1 into the patient's cavity and push the implant needle until it reaches the desired position.

[0062] Install the base assembly 1 onto the positioning auxiliary component 2, and use the lock buckle 3 to lock the slide bar 103 of the base assembly 1 to limit the position.

[0063] The patient's legs clamp the positioning aid 2, and the relative position of the extension arm 203 is adjusted according to the patient's body shape. At this time, the position of the implant needle is fixed, and when the patient is moved subsequently, the implant needle still maintains the relative position accuracy.

[0064] Before pre-installing the implant needle onto the base assembly 1, first slide the sliding plate 102 to be close to the fixed plate 101, pass the implant needle through the sliding plate 102 and the fixed plate 101 at one time, and then move the sliding plate 102 to the other end to complete the implant needle installation steps before inserting it into the cavity.

[0065] The specific structure and working principle of the present invention are as follows:

[0066] like Figure 1-Figure 3 As shown, it is an exploded view of the assembly of the base assembly 1 and the positioning auxiliary member 2 of the present invention. Both the base assembly 1 and the positioning auxiliary member 2 are made of organic glass. The selection of transparent organic glass material allows the doctor to operate under a certain degree of visibility.

[0067] The base assembly 1 is used to extend into the patient's cavity, for example, to treat gynecological tumors, especially in radical radiotherapy of cervical cancer, and to place the implant needle into the patient's vagina by means of the base assembly 1. Therefore, the outer surface of the base assembly 1 is required to be smooth, burr-free, and not have an irregular structure, so as to alleviate the patient's pain and reduce the difficulty of operation.

[0068] like Figure 5 and Figure 6As shown, the base assembly 1 includes a fixed disk 101. In one embodiment of the present scheme, three slide bars 103 are arranged on the circumference of the fixed disk 101. In the space surrounded by the three slide bars 103, a through hole is opened on the fixed disk 101. This through hole is the implant needle channel hole that allows the implant needle to pass through. The fixed disk 101 is a prototype thick disk with a diameter of 35mm and a thickness of 5mm. There are 13 implant needle channel holes in total, which are arranged in a circular array. The diameter of each implant needle channel hole is 2.4mm. Among the 13 implant needle channel holes, one is located at the center of the fixed plate, and the remaining 12 are evenly distributed on the circumferences of 14mm and 28mm in diameter at a 60-degree radiation angle.

[0069] like Figure 5 and Figure 6 As shown, a sliding plate 102 is passed through the sliding rod 103, and a connecting member 104 is provided at one end of the sliding rod 103 away from the fixed plate 101. The connecting member 104 connects all the sliding rods 103 together in the area surrounded by the sliding rods 103 to limit the movement path of the sliding plate 102. In this solution, the sliding plate 102 and the fixed plate 101 are separately provided, and the insertion needle is squeezed by the human tissue to play a role in spacing and fixing the insertion needle.

[0070] The sliding plate 102 is also provided with through holes as the insertion needle passage holes. The insertion needle passage holes on the sliding plate 102 are the same in size and distribution as the insertion needle passage holes on the fixed plate 101 .

[0071] As an optional embodiment, the slide bar 103 is composed of three round rods with a length of 90 mm and a diameter of 5 mm and a tripod-shaped connector 104. One end of the slide bar 103 is fixedly plugged into the fixed disk 101, and the other end is fixed by the connector 104 at a distance of 13 mm from the top. A lock buckle groove with a width of 1 mm and a depth of 1.3 mm is opened on the outside of the connector 104 at a distance of 4 mm from the top of the slide bar 103. The tripod connector 104 has a side width of 3 mm and a thickness of 3 mm, and a channel for the implantation needle is left in the center. The three sides of the connector 104 pass through the implantation needle hole positions.

[0072] Lock 3 structure reference Figure 4 , used to cooperate with the lock buckle 3 groove on the slide bar 103 for position limiting. The lock buckle 3 is made of a steel wire with a diameter of 1 mm and is in the shape of an open regular triangle. The steel wire at one end of the lock buckle 3 is bent to form a handle, which can be specifically bent 90° above the triangular plane and then bent outward into a ring. The function of the lock buckle 3 is to lock the base assembly 1 and the positioning auxiliary 2, so that the positioning auxiliary 2 and the base form a reliable rigid connection.

[0073] The main part of the positioning auxiliary member 2 is a piece such as Figure 1 The butterfly-shaped plate 201 shown has an inwardly sunken arc design, which firstly facilitates the doctor's observation and operation, and secondly helps to clamp the patient's thigh and increase stability.

[0074] A set of optional dimensions of the plate body 201 is: 180mm in width at the top, 140mm in width at the bottom, 190mm in height, and 8mm in thickness. The plate body 201 is wide at the top and narrow at the bottom, with four sides concave inward, shaped like a butterfly. The radii of the four sides are 85mm at the top, 55mm at the bottom, and 100mm at the left and right, respectively, and are tangent to the arcs with a radius of 10mm at the four corners to form four legs. The two upper legs each have a threaded hole with a diameter of 8mm and a pitch of 2mm, 6mm from the edge, and 3 through holes with a diameter of 5.5mm in the middle for the slide bar 103 to pass through, and the middle part is hollowed out. These three through holes with a diameter of 5.5mm are the positioning reference 202 of the slide bar 103 on the plate body 201.

[0075] The hollow part in the middle can meet the need of the implantation needle to pass through, secondly, it can facilitate the doctor to observe the implantation situation during operation, and thirdly, it can reduce the weight of the plate body 201.

[0076] An extension arm 203 is connected to each of the threaded holes on the two feet at the top of the plate body 201 through fasteners. The fasteners used can be fastening screws, and the size of the fastening screws can be selected to have an outer diameter of 8mm and a pitch of 2mm. Each extension arm 203 is 130mm long, 20mm wide, and 8mm thick. It is arc-shaped in the plane where the butterfly-shaped plate body 201 is located, and the arc radius is 100mm. The middle part of the extension arm 203 is provided with an offset hollow groove with a groove width of 6mm. The end of the extension arm 203 close to the plate body 201 has a hole with a diameter of 8.2mm at a distance of 10mm from the top of the plate body 201, for the fastening screw to pass through, so that the extension arm 203 is connected to the plate body 201, and the extension arm 203 is allowed to adjust the angle within a certain range to adapt to the differences in the bodies of patients with different fat and thin bodies.

[0077] In a plane perpendicular to the plate body 201, the extension arm 203 is bent backward 20° from the connection end with the butterfly plate 30 mm away, forming a bent shape. This bending structure can better fit the patient's body shape. Since the human leg is bent, after bending, the arc-shaped extension section 205 is equivalent to giving up more leg accommodation space, which is convenient for the patient to apply force to clamp the device, and also allows the plate body 201 to be closer to the affected area, that is, shortening the design length of the base assembly 1.

[0078] The specific operation process of using the device to arrange the implant needle is as follows, taking the treatment of cervical cancer as an example:

[0079] The first step is to take the base assembly 1, slide the sliding plate 102 until it is close to the fixed plate 101, and pass the implant needle through the sliding plate 102 and the fixed plate 101 in sequence as needed;

[0080] The second step is to slide the sliding plate 102 along the sliding rod 103 to the other end, close to the connecting piece 104;

[0081] The third step is to insert the installed base assembly 1 and the implant needle into the patient's vagina, hold the sliding plate 102 end of the base assembly 1, and push the implant needle to the target treatment position;

[0082] Step 4: Pass the plate 201 through the slide bars 103 and lock the three slide bars 103 with the triangular lock buckle 3, which is embedded in the recessed groove on the surface of the slide bar 103 to limit the position;

[0083] Step 5: Pre-tighten and install the extension arm 203, and ask the patient to clamp the left and right sides of the plate 201 with his legs, and mark the contact point between the inner thigh of the patient and the plate 201;

[0084] Step 6: Push the patient to the CT simulation room for positioning;

[0085] Step 7: perform image acquisition and transmit the acquired images to the after-treatment planning system;

[0086] Step 8: Formulate a treatment plan based on the image information and transmit it to the treatment device;

[0087] The ninth step is to push the patient to the treatment room, confirm that the mark has not moved, connect the source tube, and start the treatment.

[0088] When the device of the present invention is used, the initial state of the base assembly 1 and the positioning auxiliary component 2 is a split type. By clamping the butterfly plate at the root of the patient's thigh, the purpose of relatively fixing the state of the base assembly 1 in the cavity is achieved, reducing various uncertainties caused by the sag of the source device's own weight, the soft characteristics of the tissue, and the entanglement when connecting the source tube. The consistency of the implant needle from insertion to positioning to treatment in the patient's body is maintained, the accuracy of afterloading radiotherapy is improved, and the treatment effect is guaranteed.

[0089] The above description is an explanation of the present invention, not a limitation of the present invention. The scope of the present invention is defined in the claims. Any form of modification may be made within the scope of protection of the present invention.

Claims

1. A split rear-mounted implant needle fixing device, characterized in that: It comprises a base component (1) for probing into a patient's cavity, and a hollow positioning auxiliary component (2) located outside the patient's cavity. The base assembly (1) is detachably connected to the positioning auxiliary component (2). The implant needle is mounted on the base assembly (1) and is stabilized and limited by the base assembly (1); the base assembly (1) is stabilized and limited by the positioning auxiliary component (2); The positioning auxiliary component (2) comprises a plate body (201), the middle of the plate body (201) is hollowed out, and the outer contour of the plate body is a plurality of continuously connected inwardly concave arc-shaped edges.

2. The post-installation implant needle fixing device according to claim 1, characterized in that: The base assembly (1) comprises: The fixing plate (101) serves as a reference for installing the implant needle. The sliding plate (102) is coaxially arranged with the fixed plate (101) and moves relative to the fixed plate (101); the fixed plate (101) and the sliding plate (102) are provided with a plurality of groups of coaxial through holes for accommodating the implantation needles. The slide bar (103) connects the fixed plate (101) and the slide plate (102), and one end of the slide bar (103) away from the fixed plate (101) is detachably connected to the positioning auxiliary component (2).

3. The post-installation implant needle fixing device according to claim 2, characterized in that: The sliding bars (103) are arranged in a circular array, and connecting pieces (104) are provided between the sliding bars (103).

4. The post-installation implant needle fixing device according to claim 3, characterized in that: The sliding plate (102) slides back and forth between the connecting member (104) and the fixed plate (101).

5. The post-installation implant needle fixing device according to claim 3, characterized in that: A locking operation length is reserved on the side of the connecting member (104) facing away from the fixing plate (101).

6. The post-installation implant needle fixing device according to claim 2, characterized in that: A lock buckle (3) is connected between the base assembly (1) and the positioning auxiliary component (2), and the lock buckle (3) is locked at the end of the slide rod (103) of the base assembly (1) to apply a radial limiting force to the slide rod (103).

7. The post-installation implant needle fixing device according to claim 6, characterized in that: A positioning reference (202) is provided on the positioning auxiliary component (2), and the lock buckle (3) abuts against a side of the positioning reference (202) that is away from the base component (1).

8. The post-installation implant needle fixing device according to claim 1, characterized in that: An extension arm (203) is slidably connected to the positioning auxiliary component (2).

9. A method for maintaining the position of an implant needle using the post-installed implant needle fixing device according to claim 1, characterized in that: The steps include: The implant needle is pre-installed on the base assembly (1), and the base assembly (1) limits the position of the implant needle. Insert the base assembly (1) into the patient's cavity and push the implant needle until it reaches the desired position. Install the base assembly (1) onto the positioning auxiliary component (2), and use the lock buckle (3) to lock the slide bar (103) of the base assembly (1) into position. The patient's legs clamp the positioning auxiliary component (2), and the relative position of the extension arm (203) is adjusted according to the patient's body shape. At this time, the position of the implant needle is fixed, and when the patient is subsequently moved, the implant needle still maintains the relative position accuracy.

10. The method for maintaining the stable position of an implant needle according to claim 9, characterized in that: Before pre-installing the implant needle onto the base assembly (1), first slide the sliding plate (102) to be close to the fixed plate (101), pass the implant needle through the sliding plate (102) and the fixed plate (101) in sequence, and then move the sliding plate (102) to the other end, completing the implant needle installation steps before inserting it into the cavity.

Images