Fixing structure

Abstract

The utility model belongs to the technical field of medical instruments, and discloses a fixing structure. The fixing structure comprises a fixing piece and a fastening piece, the fixing piece comprises a main body extending in the first direction, connecting parts and a fixing part, the main body covers the connecting part, the main body is provided with a receding part used for receding welding spots of the connecting part, and the multiple connecting parts are connected to the main body and located on the two sides of the main body in the first direction respectively. The fixing part is arranged at one end, far away from the main body, of the connecting part, or the fixing part is arranged on the main body, and an angle is formed between the connecting part and the main body, so that the fixing part is close to or attached to an implantation part; the fastener can be matched with the fixing part and is connected with the implanting part, so that the fixing part is fixed on the implanting part; the first direction is the extension direction of the implantable extension wire or the electrode wire. According to the utility model, extrusion on welding spots can be avoided, the conduction stability of the implantable extension lead and the electrode lead is improved, the treatment effect is ensured, and the treatment feeling of a patient is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to a fixing structure. Background Art

[0002] Implantable Deep Brain Stimulation (DBS), also known as a brain pacemaker, is an advanced medical device used to treat a variety of neurological diseases. Specifically, it includes a pulse generator, stimulation electrodes, and implantable extension leads. Among them, the pulse generator is the core component of the deep brain stimulator. It can generate electrical pulse signals and transmit these signals to specific areas of the brain through electrode leads and implantable extension leads; the pulse generator has a variety of control programs, which can independently program the stimulation parameters of each channel, such as polarity, voltage, current, pulse width and frequency, etc., to provide patients with refined treatment options; the stimulation electrode contacts can directly stimulate the neural nuclei deep in the brain, thereby changing the propagation of the brain circuit; the implantable extension lead is used to connect the pulse generator and the stimulation electrode to ensure that the electrical pulse signal can be accurately and stably transmitted to the target area.

[0003] The implantable extension wire and the electrode wire need to be connected by welding to ensure a stable electrical connection between the two. Usually, the welding part of the implantable extension wire and the electrode wire needs to be implanted in the cranial and maxillary bone behind the ear. In order to prevent the welding part from shifting and causing an open circuit, the welding part needs to be fixed to protect the multiple welding points on the welding part.

[0004] Please see attached Figure 1 and attached Figure 2 The prior art discloses a fixing structure, which includes a long straight plate-shaped fixing body 10 and a threaded fastener 30, and through holes 20 for the threaded fastener 30 to pass through are provided at both ends of the fixing body 10. When in use, the fixing body 10 is first placed horizontally on the welding part (there is a connection welding point 40 in the welding part), and the threaded fastener 30 is locked on the implantation part. By tightening the two ends of the fixing body 10, the fixing body 10 is pressed against the welding part to ensure that the welding part is stably fixed and does not shift. The problem with the current prior art is that since the fixing body 10 is usually thicker and has higher rigidity, when the fixing body 10 is fixed, it usually takes a larger force to bend the fixing body 10. The fixing process generates a larger extrusion force on the connection welding point 40 in the welding part, causing damage to the welding part, resulting in conduction failure or unstable conduction state, and loss or lower treatment effect. Utility Model Content

[0005] The purpose of the utility model is to provide a fixing structure for fixing the connection part between the implantable extension wire and the electrode wire, avoiding squeezing of the welding point in the connection part, improving the stability of the conduction between the implantable extension wire and the electrode wire, ensuring the treatment effect, and improving the patient's treatment experience.

[0006] To achieve this purpose, the utility model adopts the following technical solutions:

[0007] A fixing structure, used for fixing the connection part between the implantable extension lead and the electrode lead, comprising:

[0008] A fixing member, comprising a main body extending in a first direction, a connecting portion and a fixing portion, wherein the main body cover is arranged on the connecting portion, the main body is provided with a clearance portion for avoiding a welding point of the connecting portion, a plurality of connecting portions are respectively connected to the main body and are located at two sides of the main body along the first direction, the fixing portion is arranged at one end of the connecting portion away from the main body, or the fixing portion is arranged on the main body, and the connecting portion and the main body are arranged at an angle;

[0009] A fastener, capable of cooperating with the fixing portion and connecting with the implantation site, so that the fixing member is fixed to the implantation site;

[0010] The first direction is the extension direction of the implantable extension lead or the electrode lead.

[0011] As an optional solution for the fixing structure, the avoidance portion is a notch formed by being recessed inwards on both sides of the main body along the first direction.

[0012] As an optional solution for a fixing structure, the air-avoiding portions are a plurality of grooves provided on the main body, and the grooves are arranged relative to the welding points.

[0013] As an optional solution for a fixing structure, the avoidance portion is a plurality of avoidance holes provided on the main body, and the avoidance holes are used to be arranged relative to the welding point.

[0014] As an optional solution for the fixing structure, a groove extending along the first direction is formed between two adjacent connecting parts, and the main body is arranged opposite to the groove.

[0015] As an optional solution for the fixing structure, the length of the main body is not less than the length of the connecting portion.

[0016] As an optional solution of the fixing structure, the fixing portion and the connecting portion are arranged at an angle so that the fixing portion fits the surface of the implantation site.

[0017] As an optional solution for the fixing structure, an outer sheath is provided on the outer periphery of the connecting portion, and the main body is an arc-shaped structure, and the curvature of the main body matches the curvature of the outer sheath.

[0018] As an optional solution of the fixing structure, the fixing portion is provided with a positioning hole, and the fastener can pass through the positioning hole and be screwed to the implantation site.

[0019] As an optional solution for a fixing structure, the main body, the connecting portion and the fixing portion are integrally constructed.

[0020] Beneficial effects:

[0021] In the present invention, when fixing the connection between the implantable extension lead and the electrode lead, the fastener cooperates with the fixing part to press the main body against the connection and avoid the welding point, thereby avoiding the extrusion force on the welding point. Compared with the technical solutions of the prior art, the stability of the conduction between the implantable extension lead and the electrode lead is improved, the treatment effect is guaranteed, and the patient's treatment experience is improved. In addition, by setting the connection part and the main body at an angle, the deformation of the fixing part can be reduced or even avoided when the connection part is fixed, thereby ensuring that the main body fixes the connection part in a surface extrusion manner, increasing the extrusion area, reducing the pressure, and preventing the extrusion force from being concentrated and damaging the connection part. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a structural schematic diagram of an implantable extension lead and an electrode lead fixation solution provided by the prior art;

[0023] Figure 2 It is a structural schematic diagram of an implantable extension lead and an electrode lead fixing solution with a partially concealed jacket structure provided by the prior art;

[0024] Figure 3 It is a structural schematic diagram of a fixing structure provided in an embodiment of the utility model for fixing an implantable extension lead and an electrode lead;

[0025] Figure 4 This is a first structural schematic diagram of a fixing structure provided by an embodiment of the utility model when a portion of the outer jacket structure is hidden and used to fix an implantable extension lead and an electrode lead;

[0026] Figure 5 This is a second structural schematic diagram of the fixing structure provided by the embodiment of the utility model when a part of the outer shell structure is hidden and used to fix the implantable extension wire and the electrode wire;

[0027] Figure 6 It is a structural schematic diagram of a fixing member with a notch provided in an embodiment of the utility model;

[0028] Figure 7 It is a structural schematic diagram of a fixing member with a groove provided in an embodiment of the utility model;

[0029] Figure 8 It is a schematic diagram of the structure of a fixing member with a avoidance hole provided by an embodiment of the utility model when fixing an implantable extension wire and an electrode wire;

[0030] Fig. 9 It is a schematic diagram of the structure of an implantable extension lead and an electrode lead with a hidden fixing structure provided in an embodiment of the utility model;

[0031] Fig.10 It is a schematic diagram comparing the lengths of the main body and the connecting parts of the embodiment of the utility model.

[0032] In the figure:

[0033] 10. Fixing body; 20. Through hole; 30. Threaded fastener; 40. Connecting welding point;

[0034] X, first direction; Y, second direction;

[0035] 100, implantable extension lead; 200, electrode lead; 300, connection part; 310, welding point; 320, groove; 330, outer sheath;

[0036] 1. fixing part; 11. main body; 111. notch; 112. groove; 113. avoidance hole; 12. connecting part; 13. fixing part; 131. positioning hole;

[0037] 2. Fasteners. DETAILED DESCRIPTION

[0038] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only the parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0039] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" 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, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0040] In the present utility model, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0041] In the description of this embodiment, the terms "upper", "lower", "right", etc., are based on the directions or positions shown in the drawings, and are only for the convenience of description and simplified operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0042] The following is a brief description of the technical field and related terms of the embodiments of the present application.

[0043] Implantable medical systems include implantable neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neural stimulation systems include deep brain stimulation (DBS), implantable cortical nerve stimulation (CNS), implantable spinal cord stimulation (SCS), implantable sacral nerve stimulation (SNS), and implantable vagus nerve stimulation (VNS).

[0044] The implantable neural electrical stimulation system includes a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device disposed outside the patient's body. In other words, the stimulator is a medical device, or in other words, the medical device includes the stimulator. The relevant neural regulation technology mainly implants electrodes (electrodes, for example, in the form of electrode wires) in specific parts of the tissues of the organism (i.e., target points) through stereotactic surgery, and emits discharge pulses to the target points through the electrodes to regulate the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain.

[0045] Please see attached Figure 3 -Attached Figure 5 , this embodiment relates to a fixing structure, which is used to fix the connection part 300 between the implantable extension wire 100 and the electrode wire 200. Specifically, the fixing structure includes a fixing member 1 and a fastener 2, wherein the fixing member 1 includes a main body 11, a connecting part 12 and a fixing part 13 extending along a first direction X, the main body 11 covers the connection part 300, and the main body 11 is provided with a vacant part for avoiding the welding point 310 on the connection part 300, a plurality of connecting parts 12 are respectively connected to the main body 11 and are located on both sides of the main body 11 along the first direction X, the fixing part 13 is provided at one end of the connecting part 12 away from the main body 11, or the fixing part 13 is provided on the main body 11, and the connecting part 12 is arranged at an angle with the main body 11 so that the fixing part 13 is close to or fits the implantation part; the fastener 2 can cooperate with the fixing part 13 and connect with the implantation part so that the fixing member 1 is fixed on the implantation part; the first direction X is the extension direction of the implantable extension wire 100 or the electrode wire 200.

[0046] In this embodiment, the fixing member 1 is a titanium alloy, which has excellent biocompatibility, can better adapt to the human body environment, and reduce the risk of rejection. At the same time, the titanium alloy also has good corrosion resistance and mechanical properties, which enables it to remain stable after being implanted in the human body, is not easily affected by the external environment, and can withstand certain pressure and load. The main body 11 extends along the first direction X and is placed on the connection part 300, and the air-avoiding part is directly opposite to the welding point 310.

[0047] When fixing the connection part 300 between the implantable extension wire 100 and the electrode wire 200, the main body 11 is pressed against the connection part 300 by the cooperation between the fastener 2 and the fixing part 13. Of course, the fixing part 13 can be directly set at the end of the connection part 12 away from the main body 11, or can be directly set on the main body 11, and can be specifically adjusted according to the gap between the two parallel connection parts 300. Exemplarily, when the gap between the two parallel connection parts 300 is very small or there is no gap, the space between the two parallel connection parts 300 is not enough to set the fastener 2, and the fixing part 13 can be directly set at the end of the connection part 12 away from the main body 11; when the space between the two parallel connection parts 300 is larger, the fixing part 13 can be directly set on the main body 11, and the setting can directly adopt the fastener 2 to pass through the main body 11 to connect with the implantation part.

[0048] Furthermore, by having the avoidance portion facing the welding point 310, the squeezing force on the welding point 310 can be avoided. Compared with the prior art, the stability of the conduction between the implantable extension wire 100 and the electrode wire 200 is improved, the treatment effect is guaranteed, and the patient's treatment experience is improved. In addition, by setting the connection portion 12 and the main body 11 at an angle, when the connection portion 300 is fixed, the fixing portion 13 can be brought close to or in contact with the implantation portion, or the end of the connection portion 12 away from the main body 11 can be brought closer to and in contact with the implantation portion, thereby reducing or even avoiding the deformation of the fixing member 1, thereby ensuring that the main body 11 fixes the connection portion 300 in a surface squeezing manner, increasing the squeezing area, reducing the pressure, and preventing the squeezing force from being concentrated and damaging the connection portion 300.

[0049] Please see attached Figure 3 -Attached Figure 6 Optionally, a positioning hole 131 is provided on the fixing portion 13, and the fastener 2 can pass through the positioning hole 131 and be screwed to the implantation site.

[0050] In this embodiment, a circular positioning hole 131 is formed on the fixing portion 13, and the fastener 2 is a screw. The screw passes through the positioning hole 131 and is screwed to the implantation site to fix the fixing member 1. The fixing method is simple and convenient.

[0051] Optionally, the main body 11 , the connecting portion 12 and the fixing portion 13 are of an integrated structure.

[0052] In this embodiment, the fixing member 1 is integrally constructed, and the connection portion 12 and the main body 11 can be formed at a preset angle through a bending process, so as to reduce the number of parts and assembly processes, thereby reducing costs.

[0053] Optionally, the plurality of connection portions 12 are symmetrically arranged relative to the main body 13 .

[0054] In this embodiment, by symmetrically arranging the connection part 12 relative to the main body 11, and correspondingly, the fixing part 13 is also symmetrically arranged, the extrusion force of the main body 11 can be more dispersed, and the concentrated force on the connection part 300 can be avoided. For example, in this embodiment, the main body 11 is symmetrically provided with two groups of connection parts 12 along the width direction, and the two groups of connection parts 12 are respectively arranged at positions close to both ends of the main body 11, so that the entire fixing member 1 is in the shape of an "I".

[0055] Optionally, the avoidance portion is a notch 111 formed by being recessed inwards on both sides of the main body 11 along the first direction X.

[0056] In one implementation form of the present embodiment, a notch 111 is formed on each side of the first direction X of the main body 11, and the notch 111 is used to avoid the welding point 310. The notch 111 can be directly formed when the fixing part 1 is formed, and can also be formed by removing material according to a set cutting trajectory in a subsequent process. The notch 111 can reduce the rigidity of the main body 11, making the main body 11 more susceptible to deformation, and further reducing the extrusion damage to the connection part 300.

[0057] Please see attached Figure 7 Optionally, the air-avoiding portion is a plurality of grooves 112 provided on the main body 11 , and the grooves 112 are arranged relative to the welding points 310 .

[0058] In one implementation form of the present embodiment, a plurality of grooves 112 may be provided on a side wall surface of the main body 11 relative to the connection portion 300. The grooves 112 are provided corresponding to the positions of the welding points 310. When the main body 11 continuously presses the connection portion 300, the grooves 112 may ensure that the main body 11 and the welding points 310 are always out of contact, thereby avoiding the generation of squeezing pressure on the welding points 310.

[0059] Please see attached Figure 8 Optionally, the avoidance portion is a plurality of avoidance holes 113 provided on the main body 11 , and the avoidance holes 113 are arranged relative to the welding point 310 .

[0060] In one implementation form of this embodiment, an avoidance hole 113 is opened in the main body 11 corresponding to the position of the welding point 310. The welding point 310 is avoided through the avoidance hole 113. The avoidance hole 113 can be formed by laser cutting. The avoidance hole 113 can also reduce the rigidity of the main body 11, making the main body 11 more susceptible to deformation, thereby reducing the extrusion damage to the connection part 300.

[0061] Please see attached Fig. 9 Optionally, a groove 320 extending along the first direction X is formed between two adjacent connecting parts 300 , and the main body 11 is arranged opposite to the groove 320 .

[0062] In this embodiment, when the implantable extension wire 100 and the electrode wire 200 are in use, they are usually arranged in parallel, and the two parallel connection parts 300 form a V-shaped groove 320. By arranging the main body 11 relative to the groove 320, the possibility of the main body 11 squeezing the internal guide wire of the implantable extension wire 100 and the electrode wire 200 can be reduced, and the probability of squeezing and deforming the guide wire can be reduced, thereby further ensuring the stability of the conduction of the implantable extension wire 100 and the electrode wire 200.

[0063] Optionally, the length of the main body 11 is not less than the length of the connecting portion 300 .

[0064] Please continue to attach Figure 3 , Attachment Figure 4 and attached Fig.10 , the welding point 310 of the connection part 300 is wrapped by the outer sheath 330, and the outer sheath 330 insulates and protects the internal guide wire and the welding point 310 on the connection part 300. The length H of the main body 11 cannot be less than the length h of the connection part 300, ensuring that the connection part 300 is evenly stressed at all positions in the length direction; further, the length H of the main body 11 can be made not greater than the length of the outer sheath 330. When the length of the main body 11 is fixed, the doctor can quickly find a suitable placement during the operation, so that the fixing part 1 will not press on the welding point 310, because if one end presses on the welding point 310, the other end may not be on the outer sheath 330, resulting in failure to fix. Only when both ends are on the outer sheath 330 and the fixing position is at both ends of the connection part 300, can the best fixation be achieved.

[0065] Optionally, an outer sheath 330 is provided on the outer periphery of the connection portion 300 , and the main body 11 is an arc-shaped structure, and the curvature of the main body 11 matches the curvature of the outer sheath 330 .

[0066] In this embodiment, the outer sheath 330 presents an arched structure that is high in the middle and low at both ends. By making the main body 11 present a certain arc in the first direction X and correspondingly matching the curvature of the main body 11 with the curvature of the outer sheath 330, the shape of the main body 11 can be more adapted to the shape of the outer sheath 330. When fixing the main body 11, the deformation of the main body 11 can be avoided or reduced, thereby reducing the squeezing force of the fixing structure on the connection part 300.

[0067] Optionally, the connection between the main body 11 and the connection portion 12 is transitioned through an arc surface.

[0068] In this embodiment, during the locking process of the fastener 2, there may be a certain displacement between the main body 11 and the connecting part 12, that is, a certain stress will be generated at the connection between the main body 11 and the connecting part 12. The connection between the main body 11 and the connecting part 12 is transitioned through an arc surface, which can avoid stress concentration, thereby improving the service life of the entire fixing part 1.

[0069] Furthermore, in this embodiment, the fixing portion 13 and the connecting portion 12 are arranged at an angle so that the fixing portion 13 fits the surface of the implantation site.

[0070] In order to ensure that the fixing portion 13 can fit the surface of the implantation site as closely as possible, the relative angle between the fixing portion 13 and the connecting portion 12 can be adjusted. For example, the angle between the fixing portion 13 and the connecting portion 12 is equal to the angle between the connecting portion 12 and the main body 11. At this time, the fixing portion 13 and the main body 11 are parallel to each other and the fixing portion 13 can be as parallel to the surface of the implantation site as possible.

[0071] Furthermore, in order to avoid stress concentration caused by displacement at the connection between the fixing portion 13 and the connecting portion 12 , the connection between the fixing portion 13 and the connecting portion 12 is also transitioned through an arc surface.

[0072] Obviously, the above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention, and are not intended to limit the implementation methods of the present invention. For those skilled in the art, various obvious changes, readjustments and substitutions can be made without departing from the scope of protection of the present invention. It is not necessary and impossible to list all implementation methods here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention shall be included in the scope of protection of the claims of the present invention.

Claims

1. A fixing structure for fixing a connection portion (300) between an implantable extension lead (100) and an electrode lead (200), characterized in that: include: A fixing member (1), comprising a main body (11) extending along a first direction (X), a connecting portion (12) and a fixing portion (13) along a second direction (Y), wherein the main body (11) is covered on the connecting portion (300), the main body (11) is provided with a clearance portion for avoiding a welding point (310) of the connecting portion (300), a plurality of connecting portions (12) are respectively connected to the main body (11) and are located on both sides of the main body (11) along the first direction (X), the fixing portion (13) is arranged at one end of the connecting portion (12) away from the main body (11), or the fixing portion (13) is arranged on the main body (11), and the connecting portion (12) and the main body (11) are arranged at an angle; A fastener (2) capable of cooperating with the fixing portion (13) and connecting with the implantation site, so that the fixing member (1) is fixed to the implantation site; The first direction (X) is the extension direction of the implantable extension lead (100) or the electrode lead (200).

2. The fixing structure according to claim 1, characterized in that: The avoidance portion is a notch (111) formed by being recessed inwards on both sides of the main body (11) along the first direction (X).

3. The fixing structure according to claim 1, characterized in that: The avoidance portions are a plurality of grooves (112) provided on the main body (11), and the grooves (112) are arranged relative to the welding points (310).

4. The fixing structure according to claim 1, characterized in that: The avoidance portion is a plurality of avoidance holes (113) provided on the main body (11), and the avoidance holes (113) are used to be arranged relative to the welding point (310).

5. The fixing structure according to claim 1, characterized in that: A groove (320) extending along the first direction (X) is formed between two adjacent connection parts (300), and the main body (11) is arranged opposite to the groove (320).

6. The fixing structure according to claim 1, characterized in that: The length of the main body (11) is not less than the length of the connecting portion (300).

7. The fixing structure according to claim 1, characterized in that: The fixing portion (13) and the connecting portion (12) are arranged at an angle so that the fixing portion (13) fits the surface of the implantation site.

8. The fixing structure according to claim 1, characterized in that: An outer sheath (330) is provided on the outer periphery of the connection portion (300); the main body (11) is an arc-shaped structure; the curvature of the main body (11) matches the curvature of the outer sheath (330).

9. The fixing structure according to any one of claims 1 to 8, characterized in that: The fixing portion (13) is provided with a positioning hole (131), and the fastener (2) can pass through the positioning hole (131) and be screwed to the implantation site.

10. The fixing structure according to any one of claims 1 to 8, characterized in that: The main body (11), the connecting portion (12) and the fixing portion (13) are of an integrated structure.

Images