Implantable electrical stimulation lead fixation patch

Abstract

The implantable electric stimulation protective sleeve fixing piece belongs to the technical field of medical devices and comprises a bending part, an inner wall surface of the bending part has an arc surface, the arc surface forms a channel for the protective sleeve to pass through, and the two ends of the bending part are respectively provided with connecting ears; the connecting ears are provided with through holes for connecting screws; the implantable electric stimulation protective sleeve fixing piece has the bending part, when cooperating with the protective sleeve, the arc surface of the bending part can better fit the protective sleeve, then when the connecting ears at the two ends of the bending part are fixed by the screws, the bending part does not need to be deformed too much, the screws can be more uniformly stressed, the firmness after the screws are tightened is improved, and the screws are prevented from falling off.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an implantable electrical stimulation protective sleeve fixing sheet. BACKGROUND

[0002] DBS (Deep Brain Stimulation, brain deep electrical stimulation) is an effective technology for treating advanced and drug-refractory movement disorders and mental disorders. It has a significant effect on the treatment of Parkinson's disease.

[0003] In the implementation of DBS surgery, after the electrode positioning and implantation are completed, the extension lead needs to be connected. After the extension lead is connected with the electrode, the protective sleeve is sleeved outside and sealed. After sealing is completed, the protective sleeve is generally fixed on the skull. At present, doctors generally use metal connecting sheets for skull bone connection. The protective sleeve is fixed on the skull by screwing.

[0004] However, the metal connecting sheet for skull bone connection is a straight plate. When fixing the protective sleeve, the metal connecting sheet is bent by tightening the screw after being wrapped outside the protective sleeve. The bent metal connecting sheet cannot be well fitted with the protective sleeve, and when the screw is tightened, the force is not uniform, which can easily cause the screw to fall off. SUMMARY

[0005] Therefore, the technical problem to be solved by the present application is to overcome the defect that the implantable electrical stimulation protective sleeve in the prior art uses a metal connecting sheet for skull bone connection to fix, which can easily cause the screw position to be stressed too much and cause the screw to fall off, thereby providing an implantable electrical stimulation protective sleeve fixing sheet.

[0006] In order to solve the above technical problems, the present application provides an implantable electrical stimulation protective sleeve fixing sheet, comprising: a curved portion, the inner wall surface of the curved portion has an arc surface, the arc surface forms a channel for the protective sleeve to pass through, and the two ends of the curved portion respectively have connecting ears.

[0007] The connecting ear has a through hole for connecting a screw.

[0008] Optionally, the curved portion and the connecting ear are integrally formed.

[0009] Optionally, the curved portion and the connecting ear are made of a high polymer material.

[0010] Optionally, the depth of the arc surface of the curved portion is equal to the height of the exposed bone groove of the protective sleeve.

[0011] Optionally, the depth of the arc surface of the curved portion is equal to half the outer diameter of the protective sleeve.

[0012] Optionally, the edge of the curved portion is rounded.

[0013] Optionally, the edge of the connecting lug is rounded.

[0014] Optionally, the through hole for connecting the screw on the connecting lug is a countersunk hole.

[0015] Optionally, the arc surface is composed of a long arc surface at the middle position and a short arc surface connected to both ends of the long arc surface.

[0016] Optionally, the curved portion has a hole passing through the arc surface.

[0017] The technical scheme of the present application has the following advantages:

[0018] 1. The implantable electrical stimulation protective sleeve fixing piece provided by the present application has a curved portion, which can better fit the protective sleeve when cooperating with the protective sleeve. Then, when the connecting lug at both ends of the curved portion is fixed by a screw, the curved portion does not need to be deformed too much, the screw can be stressed more uniformly, thereby improving the firmness after the screw is tightened, and avoiding screw falling off.

[0019] 2. The implantable electrical stimulation protective sleeve fixing piece provided by the present application, the curved portion and the connecting lug are integrally formed by a high polymer material, which will not heat up when the patient is detected by nuclear magnetic resonance, and can meet the needs of 3T and below nuclear magnetic examination.

[0020] 3. The implantable electrical stimulation protective sleeve fixing piece provided by the present application, the depth of the curved portion is equal to the height of the exposed bone groove of the protective sleeve, which can ensure that the protective sleeve is effectively fixed in the bone groove, and at the same time, will not cause the skull nail position to be stressed too much, causing the screw to fall off and other problems. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the specific embodiments of the present application or the technical scheme in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0022] Figure 1 It is a perspective view of one embodiment of the implantable electrical stimulation protective sleeve fixing piece provided in the embodiments of the present application.

[0023] Figure 2 It is a perspective view of one embodiment of the implantable electrical stimulation protective sleeve fixing piece provided in the embodiments of the present application. Figure 1 It is a use state schematic view of the implantable electrical stimulation protective sleeve fixing piece shown in the embodiments of the present application.

[0024] Figure 3Another embodiment of the implantable electrical stimulation protective sleeve fixing piece provided in the embodiments of the present application is shown in a perspective view.

[0025] Figure 4 For Figure 3 An application state diagram of the implantable electrical stimulation protective sleeve fixing piece is shown.

[0026] Figure 5 An application state diagram of the implantable electrical stimulation protective sleeve fixing piece is shown.

[0027] Explanation of reference signs:

[0028] 1, bending part; 2, arc surface; 3, channel; 4, connecting ear; 5, through hole; 6, protective sleeve; 7, long arc surface; 8, short arc surface; 9, hole; 10, groove. DETAILED DESCRIPTION

[0029] The technical solutions of the present application will be described clearly and completely below with reference to the drawings. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0030] In the description of the present application, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0031] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0032] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0033] The implantable electric stimulation protective sleeve fixing piece provided by the embodiment is used for fixing the electric stimulation protective sleeve 6 through a screw after the electric stimulation protective sleeve 6 is implanted into a human body.

[0034] As shown in Figure 1 Fig. 1, the implantable electric stimulation protective sleeve fixing piece is a specific embodiment, which comprises a curved portion 1, an arc surface 2 on an inner wall surface of the curved portion 1, a channel 3 for the protective sleeve 6 to pass through, and connecting ears 4 at two ends of the curved portion 1, wherein the connecting ears 4 are provided with through holes 5 for connecting screws.

[0035] As shown in Figure 2 Fig. 2, in use, the arc surface 2 of the curved portion 1 is arranged on an upper portion of the protective sleeve 6, the connecting ears 4 at two ends of the curved portion 1 are outwardly extended, and the screws are screwed on the bone through the through holes 5 on the connecting ears 4, so that the protective sleeve 6 is fixed by the fixing piece. The implantable electric stimulation protective sleeve fixing piece provided by the embodiment has the curved portion 1, when the curved portion 1 is matched with the protective sleeve 6, the arc surface 2 of the curved portion 1 can better adhere to the protective sleeve 6, then when the connecting ears 4 at two ends of the curved portion 1 are fixed by the screws, the curved portion 1 does not need to be deformed too much, the screws can be more uniformly stressed, so that the firmness after the screws are screwed is improved, and the screws are prevented from falling off.

[0036] In the implantable electric stimulation protective sleeve fixing piece provided by the embodiment, the curved portion 1 and the connecting ears 4 are integrally formed. In addition, as an alternative embodiment, the curved portion 1 and the connecting ears 4 can also be detachably connected, such as clamping, plugging and the like.

[0037] In the implantable electric stimulation protective sleeve fixing piece provided by the embodiment, the curved portion 1 and the connecting ears 4 are made of implantable high polymer materials, such as polymethyl methacrylate, ultrahigh molecular polyethylene and the like, so as to meet the requirement of 3T and below nuclear magnetic examination. Compared with metal materials, the toughness of the high polymer materials is better.

[0038] In the implantable electrical stimulation protective sleeve fixing piece provided by the embodiment, the depth of the curved portion 1 is adapted to the protective sleeve 6 and the depth of the skull slot, so that the depth of the curved portion 1 is equal to the height of the exposed bone slot of the protective sleeve 6. In this way, the protective sleeve 6 can be effectively fixed in the bone slot, and the force on the skull screw is not too large, so that the screw is not easily detached. Specifically, the protective sleeve 6 is sunk into the bone slot, and the depth of the bone slot is preferably half of the outer diameter of the protective sleeve 6. Therefore, in the implantable electrical stimulation protective sleeve fixing piece of the embodiment, the depth of the curved portion 1 is equal to half of the outer diameter of the protective sleeve 6. The effect of this design is that the width of the bone slot is just equal to the outer diameter of the protective sleeve 6, and the arc surface 2 just forms a stable wrapping around the part of the protective sleeve 6 exposed to the bone slot. At the same time, since the extension directions of the two ends of the arc surface 2 are basically perpendicular to the surface of the skull, after the screw is installed on the connecting lug 4, the force direction of the screw is basically along the direction perpendicular to the surface of the skull, so that the screw is uniformly stressed while the protective sleeve 6 is stably wrapped.

[0039] As shown in Figure 1 In order to prevent the protective sleeve 6 from being damaged due to excessive pressure and to avoid the abrasion of the skin, the edge of the curved portion 1 is designed as a rounded corner, and the edge of the connecting lug 4 is also designed as a rounded corner. In order to prevent the screw head from abrading the skin, the through hole 5 on the connecting lug 4 for connecting the screw is a countersunk hole, so that the connected screw is as much sunken as possible.

[0040] As shown in Figure 3 In another embodiment of the implantable electrical stimulation protective sleeve fixing piece provided by the embodiment, the curved portion 1 has a certain length, so that it can be used to fix two parallel protective sleeves 6. Specifically, the arc surface 2 of the curved portion 1 is composed of a long arc surface 7 at the middle position and short arc surfaces 8 connected to the two ends of the long arc surface 7. The long arc surface 7 is used to press on the upper part of the protective sleeve 6, and its curvature is larger than that of the short arc surface 8, which is suitable for extending along the surface of the skull. The short arc surface 8 wraps around the side of the protective sleeve 6 and is used to connect the connecting lugs 4 at both ends. Preferably, the curvature radius of the short arc surface 8 is equal to half of the outer diameter of the protective sleeve 6. In a preferred embodiment, one side of the curved portion 1 has a groove 10. Preferably, the position of the groove 10 corresponds to the connecting position of the long arc surface 7 and the short arc surface 8, and more preferably, it is located on the outside of the curved portion 1. The groove 10 can facilitate the adjustment of the angle between the long arc surface 7 and the short arc surface 8, and further facilitate the adjustment of the contact angle between the connecting lug 4 and the bone, so that the screw is more uniformly stressed when the screw is installed.

[0041] In addition, as a preferred embodiment, the bent portion 1 of the implantable electrical stimulation protective sleeve fixation piece provided in this embodiment has a hole 9 passing through the long arc surface 7. The hole 9 can serve as a vent, used to expel excess gas generated during the installation process after the fixation piece is installed on the protective sleeve 6. At the same time, the hole 9 can be used to view the condition of the two fixed side-by-side protective sleeves 6; furthermore, the observation hole 9 is preferably designed as an elongated hole, which facilitates venting and allows for the viewing of more areas.

[0042] like Figure 4 The diagram illustrates the use of the implantable electrical stimulation protective sleeve fixation piece provided in this embodiment on the human head. During DBS surgery, after the electrode is positioned and implanted, an extension wire needs to be connected. After the extension wire is connected to the electrode, a protective sleeve is fitted over it and sealed. After sealing, the protective sleeve is fixed to the skull using the implantable electrical stimulation protective sleeve fixation piece provided in this embodiment. Specifically, screws are used at both ends of the protective sleeve to press it into the bone groove for fixation.

[0043] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An implantable electrical stimulation protective sleeve fixation patch, characterized in that, The invention relates to a curved part (1) with an inner wall surface having an arc surface (2) forming a channel (3) for a protective sleeve (6) to pass through, and two connecting ears (4) at the two ends of the curved part (1) respectively. The connecting ears (4) have through holes (5) for connecting screws. The arc surface (2) is composed of a long arc surface (7) at the middle position and two short arc surfaces (8) connected to the two ends of the long arc surface (7) respectively. One side of the curved part (1) has a groove (10) corresponding to the connecting position of the long arc surface (7) and the short arc surface (8), and the groove (10) is located on the outside of the curved part (1). The depth of the arc surface (2) of the curved part (1) is equal to the height of the exposed bone groove of the protective sleeve (6). The curved part (1) is used for fixing two parallel protective sleeves (6). The long arc surface (7) is used for pressing on the upper part of the protective sleeve (6), the short arc surface (8) is wrapped around the side of the protective sleeve (6) and is used for connecting the two connecting ears (4), and the groove (10) is used for adjusting the angle between the long arc surface (7) and the short arc surface (8) to adjust the contact angle between the connecting ears (4) and the bone, so that the screw is uniformly stressed. The curved part (1) and the connecting ears (4) are integrally formed.

2. The implantable electrical stimulation lead fixation tab of claim 1, wherein: The curved part (1) and the connecting ears (4) are made of a high polymer material.

3. The implantable electrical stimulation lead fixation patch of claim 1, wherein: The depth of the arc surface (2) of the curved part (1) is equal to half of the outer diameter of the protective sleeve (6).

4. The implantable electrical stimulation lead fixation tab of claim 1, wherein: The edges of the curved part (1) are rounded.

5. The implantable electrical stimulation lead fixation tab of claim 1, wherein: The edges of the connecting ears (4) are rounded.

6. The implantable electrical stimulation lead fixation tab of claim 1, wherein: The through holes (5) for connecting screws on the connecting ears (4) are countersunk holes.

7. The lead fixation tab of claim 1, wherein the lead fixation tab is configured to be implanted in a patient. The curved part (1) has a hole (9) passing through the arc surface (2).

8. The lead fixation tab of any one of claims 1-7, wherein the lead fixation tab is configured to be implanted in a patient. ​

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