CN115633964A - Electrode contact, cortical electrode and implantable medical device - Google Patents
Electrode contact, cortical electrode and implantable medical device Download PDFInfo
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- CN115633964A CN115633964A CN202211567600.7A CN202211567600A CN115633964A CN 115633964 A CN115633964 A CN 115633964A CN 202211567600 A CN202211567600 A CN 202211567600A CN 115633964 A CN115633964 A CN 115633964A
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Abstract
The invention relates to the field of medical equipment, and provides an electrode contact, a cortical electrode and an implantable medical equipment, wherein the electrode contact comprises a contact part, a first fixing part and a second fixing part, the second fixing part can be arranged on the first fixing part and can also be arranged on the side wall of the contact part, compared with the existing contact structure, the connecting part between the electrode contact and a substrate is increased, the connecting strength between the electrode contact and the substrate is improved, and the height of the contact part in the thickness direction of the electrode contact is H 1 The maximum length of the projection shape of the contact part in the thickness direction is D, and the height of the second fixing part in the thickness direction of the electrode contact is H 2 Wherein 0.1D is less than or equal to H 1 Less than or equal to 0.5D, and the contact part of the contact is completeThe shape of the electrode body is kept flat, the influence of the increase of the thickness of the matrix on the implantation of the cortical electrode in the body is avoided, and the height of the electrode body is 0.5H 1 ≤H 2 ＜H 1 The connection strength of the electrode contact and the base body in the transverse direction (vertical thickness direction) is ensured, and the electrode contact is limited from transversely shaking in the base body.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an electrode contact, a cortical electrode and an implantable medical instrument.
Background
Epilepsy is caused by abnormal firing of neurons in the brain, generally due to genetic factors and traumatic brain injury. The previous research shows that characteristic abnormal brain electrical activity before the epileptic seizure exists, and the characteristic abnormal brain electrical activity can be used for predicting the abnormal seizure. The implanted cortical electrode monitors the area of the cerebral cortical region, senses and records abnormal signals of the brain, and can provide basis for diagnosis and treatment of epilepsy and related diseases. The electrode substrate of the conventional cortical electrode is soft, and the contact is easy to separate from the substrate after being installed.
Disclosure of Invention
In view of this, the present invention provides an electrode contact, a cortical electrode and an implantable medical device, in which a first fixing portion and a second fixing portion of the electrode contact are respectively connected to a substrate, so as to enhance the connection strength between the electrode contact and the substrate.
A first aspect of the present invention provides an electrode contact comprising:
a contact part having a bottom wall and a side wall connected to the bottom wall, the contact part having a height H in the thickness direction of the electrode contact 1 The maximum length of the projection shape of the contact part in the thickness direction is D;
the first fixing part is connected with the side wall and protrudes out of the outer wall surface of the side wall; and
a second fixing part provided on the first fixing part and/or the side wall and extending in the thickness direction of the electrode contact, the second fixing part having a height H in the thickness direction of the electrode contact 2 ；
Wherein the first fixing part and the second fixing part are respectively used for connecting with the substrate, and H is more than or equal to 0.1D 1 ≤0.5D，0.5H 1 ≤H 2 ＜H 1 。
Further, said H 2 The value range of H is more than or equal to 0.05mm 2 ＜5mm。
Further, the first fixing part and the second fixing part, the first fixing part and the side wall, and the side wall and the bottom wall are integrally formed;
the side wall is surrounded to form a hollow columnar structure, the bottom wall is positioned on one axial side of the side wall, the first fixing part is annularly arranged on the other axial side of the side wall, and a plurality of second fixing parts are circumferentially arranged on the first fixing part;
the bottom wall is circular in the thickness direction, the diameter of the circle of the bottom wall is equal to D, the ring width of the first fixing part is W, and W is more than or equal to 0.2D and less than or equal to 0.5D.
Further, the second fixing portion includes a folded portion extending in the thickness direction of the electrode contact, and the folded portion is located at an outer edge of the first fixing portion away from the side wall.
Furthermore, the turning part is curved in an arc shape or bent in an arc shape in multiple sections, the length of the turning part in the vertical thickness direction is L, the thickness of the turning part is T, and L is more than or equal to 2T and less than or equal to 3T.
Furthermore, the turning part is curved in an arc shape or bent in an arc shape in multiple sections, the length of the turning part in the vertical thickness direction is L, L is more than or equal to 0.2mm and less than or equal to 2mm, the thickness of the turning part is T, and T is more than or equal to 0.1mm and less than or equal to 0.8mm.
Furthermore, the first fixing portion is provided with a plurality of folded portions, at least one folded portion extends towards the bottom wall, and the other folded portions extend back to the bottom wall.
The invention provides a skin layer electrode in a second aspect, which comprises a substrate and the electrode contact;
the base body is mounted with a plurality of the electrode contacts.
Further, the distance between two adjacent electrode contacts is 1mm-15mm;
and a reinforcing piece is laid in the base body, and the rigidity of the reinforcing piece is greater than that of the base body.
Further, one side of the base body, which is used for being in contact with the cortex layer, is provided with an installation groove, and a matching part is arranged in the installation groove;
the first fixing part is clamped in the mounting groove, the contact part is located outside the base body, and the second fixing part is connected with the matching part.
In a third aspect, the invention provides an implantable medical device comprising the cortical electrode described above.
In the invention, the first fixing part can be used as the outer edge of the contact part and fixed in the substrate, the second fixing part extends in the thickness direction of the electrode contact, and the thickness direction of the electrode contact in the substrate is increasedThe contact area improves the connection strength of the electrode contact and the substrate, solves the problem that the electrode contact is easy to separate from the substrate, wherein H is more than or equal to 0.1D 1 The size is less than or equal to 0.5D, so that the overall shape of the contact part of the contact keeps flat, and the increase of the thickness of a substrate caused by the increase of the thickness of the electrode contact is avoided, and the influence on the implantation of a cortical electrode into a body is avoided; 0.5H 1 ≤H 2 ＜H 1 The extension height of the electrode contact in the thickness direction can be ensured, the connection strength of the electrode contact with the substrate in the transverse direction (vertical thickness direction) is improved, and the electrode contact is limited from transversely shaking in the substrate, H 2 Value less than H 1 The first fixing part and the second fixing part are combined, and the risk of separating the electrode contact from the substrate is reduced on the whole.
Drawings
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Fig. 1 is a perspective view of an electrode contact including an upper fixing jaw according to an embodiment of the present invention.
Fig. 2 is a schematic top view of an electrode contact including an upper holding claw in an embodiment of the present invention.
Fig. 3 is a side view of an electrode contact including an upper stationary jaw in an embodiment of the present invention.
Fig. 4 is a schematic view of an electrode contact including a lower fixing jaw in an embodiment of the present invention.
Fig. 5 is a schematic view of an electrode contact including an upper fixation fold in an embodiment of the invention.
Fig. 6 is a schematic view of an electrode contact including a lower fixation fold in an embodiment of the invention.
Fig. 7 is a schematic, partially cross-sectional view of an electrode contact including a lower fixation fold in an embodiment of the invention.
Fig. 8 is a schematic view of an electrode contact including a fixing hole in an embodiment of the present invention.
Fig. 9 is a schematic view of an electrode contact including a recess in an embodiment of the present invention.
Fig. 10 is a schematic view of another perspective of an embodiment of the present invention in which the electrode contact includes a recess.
Fig. 11 is a schematic view of a multi-lumen protective tube in an embodiment of the present invention.
FIG. 12 is a schematic representation of a cortical electrode in an embodiment of the invention.
FIG. 13 is a schematic illustration of an embodiment of the invention in which the cortical electrode has two rows of electrode contacts.
FIG. 14 is another schematic illustration of an embodiment of the invention in which the cortical electrode has two rows of electrode contacts.
FIG. 15 is a schematic representation of a sheath electrode having two branch segments in accordance with an embodiment of the present invention.
Description of reference numerals:
11. an electrode contact; 12. a substrate; 13. a wire; 14. protecting the tube; 141. a branch pipe section; 142. a peripheral cavity; 143. a central lumen; 144. a protective sleeve; 15. connecting the contacts; 16. an insulating section; 17. a channel; 18. a contact identification; 19. assembling the mark; 111. a contact point contact portion; 1111. a bottom wall; 1112. a side wall; 112. a first fixed part; 113. a second fixed part; 1131. an upper fixed jaw; 1132. a lower fixed jaw; 1133. an upper fixed folding edge; 1134. a lower fixed folding edge; 1135. a fixing hole; 1136. a recess.
Detailed Description
The present invention will be described below based on examples, but the present invention is not limited to only these examples. In the following detailed description of the present invention, certain specific details are set forth. It will be apparent to one skilled in the art that the present invention may be practiced without these specific details. Well-known methods, procedures, components and circuits have not been described in detail so as not to obscure the present invention.
Further, those of ordinary skill in the art will appreciate that the drawings provided herein are for illustrative purposes and are not necessarily drawn to scale.
Unless the context clearly requires otherwise, throughout this specification, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, what is meant is "including, but not limited to".
In the description of the present invention, it is to be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.
Unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are intended to be inclusive and mean that, for example, they may be fixedly connected or detachably connected or integrally formed; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.
Spatially relative terms, such as "inner," "outer," "below," "lower," "above," "upper," and the like, are used herein for ease of description to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the example term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
Epilepsy is caused by abnormal firing of neurons in the brain, generally due to genetic factors and traumatic brain injury. The previous research shows that characteristic abnormal brain electrical activity before the epileptic seizure exists, and the characteristic abnormal brain electrical activity can be used for predicting the abnormal seizure. The cortical electrode is implanted to monitor the area of the cerebral cortical region, sense and record abnormal signals of the brain, and provide basis for diagnosing and treating epilepsy and related diseases. Conventional cortex electrode is because the electrode base member is softer, and the contact is less, and the contact has the risk of deviating from the base member in implantation and the use, and in case the contact deviates from the base member, the deviation appears in the contact monitoring position and leads to the monitoring data deviation, and treatment position judges the mistake, destroys the intensive functional area of brain very easily, causes irretrievable influence.
Based on the above, the invention provides an electrode contact, a cortical electrode and an implantable medical device, the implantable medical device is provided with the cortical electrode, the electrode contact 11 is provided on the substrate 12 of the cortical electrode, the electrode contact 11 comprises a contact part 111, a first fixing part 112 and a second fixing part 113, and the contact part 111 is used for contacting with the cortical layer of the brain of a human body and can collect and receive weak electroencephalogram signals. The first fixing portion 112 is fixed in the substrate 12 of the skin layer electrode, the second fixing portion 113 is connected with the substrate 12, the first fixing portion 112 and the second fixing portion 113 enhance the connection strength between the electrode contact 11 and the substrate 12, and the second fixing portion 113 may be disposed on the first fixing portion 112 or on the sidewall 1112 of the contact portion 111. Compared with the existing contact structure, the invention increases the connecting part between the electrode contact 11 and the substrate 12, reduces the risk that the electrode contact 11 is separated from the substrate 12, and the height of the contact part 111 in the thickness direction of the electrode contact is H 1 The maximum length of the projection shape of the contact point contact part 111 in the thickness direction is D, wherein H is more than or equal to 0.1D 1 Less than or equal to 0.5D, the overall shape of the contact part 111 is kept flat, the thickness of the electrode contact 11 is controlled, and the influence on the cortical electrode implantation body caused by the increase of the thickness of the substrate 12 is avoided. The second fixing portion 113 has a height H in the thickness direction of the electrode contact 2 ，0.5H 1 ≤H 2 ＜H 1 The connection strength of the electrode contact 11 and the base body 12 in the transverse direction (vertical thickness direction) is ensured, the electrode contact 11 is limited from transversely shaking in the base body 12, and the risk of separation of the electrode contact 11 and the base body 12 is reduced on the whole.
Wherein, the length D refers to the linear distance between two points farthest away on the projection shape.
Fig. 1 is a schematic perspective view of an electrode contact 11 including an upper fixing claw 1131 according to an embodiment of the present invention. Fig. 2 is a schematic top view of the electrode contact 11 including the upper fixing jaw 1131 according to the embodiment of the present invention. Fig. 3 is a schematic side view of an embodiment of the present invention in which the electrode contact 11 includes an upper holding claw 1131. Fig. 4 is a schematic diagram of the electrode contact 11 including the lower fixing claw 1132 according to the embodiment of the present invention, in which the upper fixing claw 1131 and the lower fixing claw 1132 extend in opposite directions. Fig. 5 is a schematic view of electrode contact 11 including upper retaining flange 1133 in an embodiment of the present invention. FIG. 6 is a schematic view of electrode contact 11 including lower retaining flange 1134 in accordance with an embodiment of the present invention; the upper fixation flap 1133 and the lower fixation flap 1134 extend in opposite directions. Fig. 7 is a schematic partial cross-sectional view of an embodiment of the invention in which the electrode contact 11 includes a lower retention flange 1134. Fig. 8 is a schematic diagram of the electrode contact 11 including the fixing holes 1135 according to the embodiment of the present invention, and the number, shape and size of the fixing holes 1135 are not limited to those shown in fig. 8. Fig. 9 is a schematic view of an embodiment of the present invention in which the electrode contact 11 includes a recess 1136. Fig. 10 is a schematic view of another perspective in which the electrode contact 11 includes the recess 1136 in the embodiment of the present invention.
Referring to fig. 1-10, an electrode contact 11 is provided, in application, the electrode contact 11 is connected to a stimulator through a lead 13, the electrode contact 11 is in contact with the cerebral cortex of a human body, and transmits the collected weak electroencephalogram signals to the stimulator, and also transmits pulses emitted by the stimulator to the cerebral cortex to relieve symptoms.
The electrode contact 11 includes a contact portion 111, a first fixing portion 112, and a second fixing portion 113. Conventionally, the electrode contact 11 is mounted on the base 12, the contact portion 111 is for contact with the cerebral cortex, and the contact portion 111 has a side wall 1112 and a bottom wall 1111. Therefore, the bottom wall 1111 and at least a portion of the side wall 1112 or only the bottom wall 1111 of the contact portion 111 are exposed from the substrate 12.
The side wall 1112 is connected to the bottom wall 1111, the bottom wall 1111 is spaced from the base 12, and the side wall 1112 is positioned between the bottom wall 1111 and the base 12, it being understood that the bottom wall 1111 is positioned on the side of the side wall 1112 remote from the base 12. The first fixing portion 112 is connected to the sidewall 1112 of the contact contacting portion 111, the first fixing portion 112 extends toward the outer wall surface away from the sidewall 1112, that is, the first fixing portion 112 protrudes from the outer wall surface of the sidewall 1112, and the first fixing portion 112 is used for being connected to the substrate 12, so that the plurality of electrode contacts 11 are conveniently fixed to the substrate 12.
In some embodiments, the first fixing portion 112 may also serve as an outer edge of the contact portion 111, and the contact portion 111 and the first fixing portion 112 form a "straw hat" structure in combination. The first fixing portion 112 is fixed in the substrate 12, so that the electrode contact 11 is prevented from being separated from the substrate 12, the monitoring deviation caused by the deviation of the monitoring position is prevented, and the monitoring precision is improved.
Further, the contact portion 111 and the first fixing portion 112 may be formed by integral processing, a person skilled in the art selects a metal conductive material and forms the contact portion 111 and the first fixing portion 112 by stamping, a side wall 1112 of the contact portion 111 surrounds to form a hollow cylindrical structure, and a maximum length of a projection shape of the contact portion 111 in the thickness direction of the electrode contact 11 is an outer diameter of the contact portion 111. After the electrode contact 11 is mounted on the substrate 12, a portion of the substrate 12 may fill a cavity surrounded by the sidewall 1112, so as to improve the connection strength between the electrode contact 11 and the substrate 12. The bottom wall 1111 of the contact portion 111 is located on one side of the side wall 1112 in the axial direction, the first fixing portion 112 is annularly provided on the other side of the side wall 1112 in the axial direction, and the bottom wall 1111 has a circular shape in the thickness direction of the electrode contact 11 and has a diameter equal to the outer diameter of the contact portion 111.
The contact portion 111 and the first fixing portion 112 may be formed by machining, welding, or the like, or may be formed by machining metal into an implantable contact. The outer side of the joint of the bottom wall 1111 and the side wall 1112 is provided with a rounded surface to prevent the electrode contact 11 from scratching the cerebral cortex.
The electrode contact 11 may be made of nickel-chromium alloy, titanium alloy, platinum-iridium alloy, or medical stainless steel, and preferably made of titanium alloy.
The second fixing portion 113 is disposed on the first fixing portion 112 and/or the sidewall 1112 of the contact contacting portion 111. Therefore, the second fixing portion 113 is disposed at three positions: the second fixing portion 113 is disposed on the first fixing portion 112, the second fixing portion 113 is disposed on a side wall 1112 of the contact portion 111, and the second fixing portion 113 is disposed on the side wall 1112 of the first fixing portion 112 and the contact portion 111, respectively.
The second fixing portion 113 is used for connecting to the base 12, and increases the connecting portion between the electrode contact 11 and the base 12 and improves the connecting strength between the electrode contact 11 and the base 12, compared to the conventional contact structure.
The side of the substrate 12 for contacting with the cortex is a plane, the contact portion 111 is at least partially exposed on the side of the substrate 12 contacting with the cortex, for example, the bottom wall 1111 is exposed on the substrate 12, and the sidewall 1112 is entirely located in the substrate 12 or partially located on the substrate 12. Preferably, the second fixing portion 113 is disposed at a portion of the sidewall 1112 located in the base 12, and the second fixing portion 113 may be a concave-convex structure formed on the sidewall 1112, a radially extending rib-shaped structure, or a bent claw-shaped structure.
In another embodiment, when the second fixing portion 113 is disposed at a position where the side wall 1112 is located outside the base 12, the second fixing portion 113 needs to extend in a direction away from the side wall 1112 and incline in a direction away from the bottom wall 1111, so as to ensure that the second fixing portion 113 can be connected to the base 12.
When the second fixing portion 113 is provided only on the side wall 1112, two structures for connecting to the base 12 are provided in the axial direction corresponding to the contact portion 111. These two structures (the first fixing portion 112 and the second fixing portion 113 on the side wall 1112) are provided independently, and the connection strength between the electrode contact 11 and the substrate 12 is improved by the multi-layer structure and multi-point connection between the contact portion 111 and the substrate 12.
When the second fixing portions 113 are respectively provided on the side walls 1112 of the first fixing portion 112 and the contact portion 111, it is equivalent to that the second fixing portions 113 are provided only on the side walls 1112, and the second fixing portions 113 are provided on the first fixing portion 112, so that the connection strength between the first fixing portion 112 and the substrate 12 and the connection strength between the contact portion 111 and the substrate 12 are enhanced, and the electrode contact 11 and the substrate 12 are prevented from being separated.
The embodiment of the present invention is described with emphasis on the second fixing portion 113 being disposed only on the first fixing portion 112. After the first fixing portion 112 is fixedly connected to the substrate 12, the second fixing portion 113 located on the first fixing portion 112 is also connected to the substrate 12, so as to improve the connection strength between the first fixing portion 112 and the substrate 12.
The second fixing portion 113 includes a folded portion extending in the thickness direction of the electrode contact 11, and the extending height of the folded portion can be designed according to the thickness of the substrate 12. In the present invention, the first fixing portion 112 and the second fixing portion 113 may be formed by integral processing.
The folding part is a fixed claw which is of an arc-shaped bending structure. Referring to fig. 1, one end of the fixing claw is connected to a side of the first fixing portion 112 away from the side wall 1112. Further, the fixing claws are connected to the outer edge of the first fixing portion 112 away from the side wall 1112, the other ends of the fixing claws are inclined toward the side away from the bottom wall 1111, and the fixing claws are curved in an arc shape to form the upper fixing claws 1131.
As shown in connection with fig. 2-3, the outer diameter D of the contact portion 111 is between 1mm and 10mm, and the size of the contact portion 111 can be designed according to the number of nerve cells that require stimulation or signal collection. Height H of contact portion 111 in thickness direction of electrode contact 11 1 ，H 1 The size relationship between D and H is more than or equal to 0.1D 1 Not more than 0.5D, i.e. not less than 0.1mm and not more than H 1 Less than or equal to 5mm, the whole shape of the contact point 111 keeps flat, the thickness of the substrate 12 is effectively controlled, and the over-thickness of the cortical electrode is avoided. In the presence of a catalyst satisfying H 1 Based on the relationship with D, further, H 1 H in the range of 0.5mm to 5mm, or one step more 1 The value range is between 0.8mm and 3 mm. H 1 An undersize results in thinning of the substrate below the first fixing portion 112, weak fixing of the electrode contact 11, and H 1 The size is increased, and the overall thickness of the cortical electrode is increased, resulting in an excessively thick cortical electrode which is inconvenient to implant into the human body.
The upper fixing claws 1131 extend in the thickness direction of the electrode contact 11 in the direction away from the bottom wall 1111 by a height H 2 ，H 1 And H 2 Satisfies the size relationship of 0.5H 1 ≤H 2 ＜H 1 I.e. H is not more than 0.05mm 2 < 5mm, each H 1 Value corresponding to H 2 Is a range value such that H can be selected according to the thickness of the substrate 2 Value, thereby reducing the thickness of the cortical electrode and ensuring the electrode contact 11 in the transverse direction to the base body 12. When H is present 2 When the value is a wide range, H can be further defined within the wide range 2 The value is between 0.2mm and 2mm, or further limit H 2 The value range is between 0.5mm and 1.5 mm. H 2 The extension height is too small, the upper fixing claw 1131 can not hook the base 12 tightly 2 Too great an extension height, i.e. an increase in the thickness of the electrode contact 11, also increases the thickness of the base body 12, which is disadvantageous for implantation in the body.
The width of the first fixing portion 112 (the length of the first fixing portion 112 protruding from the outer wall surface of the sidewall 1112) is W, and the dimensional relationship between W and D satisfies 0.2D ≤ W ≤ 0.5D. The ring width is too small, the fixing strength of the first fixing part 112 in the substrate 12 is small, the ring width is too large, the size of the electrode contact 11 is increased, the distribution density of the electrode contact 11 on the substrate 12 is reduced, and intensive stimulation or monitoring on the neuron contact of the cerebral cortex cannot be formed. Furthermore, the ring width W is between 0.2mm and 4mm, and further, on the basis of meeting the relation between W and D, the value range of the ring width W is between 0.5mm and 2mm. The distribution density of the electrode contacts 11 on the substrate 12 is allowed to be ensured under the condition that the electrode contacts 11 can meet a certain connection strength with the substrate in the vertical direction.
The thickness of the upper fixing claw 1131 is T, T is between 0.1mm and 0.8mm, the radial length of the upper fixing claw 1131 is L, and when L = T, the upper fixing claw 1131 has no bending and no transverse extension. Therefore, the relationship between L and T needs to satisfy that L is not less than 3T and not more than 2T, and the value of L is between 0.2mm and 2.4mm, so that the upper fixing claw 1131 has certain bending, the connection strength between the upper fixing claw and the base body is improved, and the size of the electrode contact 11 is not excessively increased. Under the condition of satisfying the relation between L and T, the value of L is more than or equal to 0.2 and less than or equal to 2mm, the curvature of the upper fixing claw 1131 can be changed to a certain extent by adjusting the radial length L of the upper fixing claw 1131, so that the upper fixing claw 1131 can hook the substrate 12, and if the radial length L of the upper fixing claw 1131 is too long, the size of the electrode contact 11 is increased, and the distribution quantity of the electrode contacts 11 in the substrate 12 is influenced.
As shown in fig. 4, the other end of the fixed claw is inclined toward the bottom wall 1111 side, and the fixed claw extends toward the bottom wall 1111 side in the thickness direction of the electrode contact 11, and the fixed claw is curved in an arc shape to form the lower fixed claw 1132. In the present embodiment, the upper clamping claw 1131 and the lower clamping claw 1132 have the same size, but extend in opposite directions. Further, in H 1 And H 2 Within the range of values, H can be limited 2 Is less than H 1 The lower fixing claw 1132 is prevented from extending out of the base 12 to scratch the cortex.
When a plurality of fixing claws are provided in the first fixing portion 112, the extending directions of the fixing claws may be the same or different. Such as: when the first fixing portion 112 is provided with four fixing claws, the four fixing claws may all extend toward the same direction, or at least one fixing claw extends toward the direction close to the bottom wall 1111 to form the lower fixing claw 1132, and the other fixing claws extend toward the direction away from the bottom wall 1111 to form the upper fixing claw 1131, so that the electrode contact 11 is fixed more stably in the base body 12.
After the first fixing portion 112 is fixed in the base 12, a part of the base 12 is located at the bending position of the fixing claws, so that the fixing claws can hook the base 12. A plurality of fixing claws are distributed on the circumference of the first fixing part 112, the fixing claws extend along the outer contour of the first fixing part 112, the radian k corresponding to the fixing claws is between 0.1rad and 2rad, the corresponding radian is too small, the fixing claws become small and cannot hook the base body tightly, the corresponding radian is too large, the number of the settable fixing claws is reduced, and the bending difficulty of the fixing claws is increased. The number of the fixed claws according to the requirement can be designed into the extending radian of the fixed claws, and a plurality of fixed claws are uniformly distributed in the circumferential direction of the first fixing part 112 as far as possible to form multi-point connection.
In some embodiments, the first fixing portion 112 may be integrally bent, and the first fixing portion 112 is bent toward or away from the bottom wall 1111, so that the first fixing portion 112 can hook the substrate 12 to some extent.
In some embodiments, the fixing claws may be bent in multiple sections to form an arc shape, the inner side surface of each bent structure may be a plane, and multiple planes are connected to form an uneven surface inside the bending, so as to enhance the connection strength between the fixing claws and the base 12. Taking fig. 1 and 4 as an example, the inner side surface of the whole bent fixing claw is a smooth curved surface. Therefore, the multi-segment bending can be understood as increasing the roughness of the bent inner side surface of the fixed claw, so that the friction between the inner side surface of the fixed claw and the base body 12 is increased, and the fixed claw and the base body 12 can be separated by larger external force.
The folded portion may also be a fixed folded edge, and the fixed folded edge is disposed on a side of the side wall 1112 of the first fixing portion 112 away from the contact contacting portion 111. Preferably, the fixing fold is disposed at an outer edge of the first fixing portion 112 away from the sidewall 1112. As shown in fig. 5, the folded portion extends to a side away from the bottom wall 1111 to form an upper fixing fold 1133. As shown in fig. 6-7, the flap portion extends toward a side adjacent to the bottom wall 1111 to form a lower fastening flap 1134. The extension height of the fixed folding edge is between 0.05mm and 4mm, further, the extension height of the fixed folding edge is between 0.2mm and 2mm, and the extension height of the fixed folding edge is less than H I And the lower fixed folding edge 1134 is prevented from scratching the skin layer after extending out of the substrate 12, and the extension height of the fixed folding edge is designed according to the size of the electrode contact 11 and the thickness of the substrate 12.
The fixing folding edge may be integrally formed with the first fixing portion 112, that is, the outer edge of the first fixing portion 112 away from the sidewall 1112 is extended and folded to form the fixing folding edge. When the first fixing portion 112 is annular, the fixing folded edge is also annular.
The thickness of the substrate 12 is defined as vertical and the transverse direction is perpendicular to the vertical. It is understood that the first fixing portion 112 extends laterally within the base 12, the second fixing portion 113 extends vertically (in the thickness direction) within the base 12, and the first fixing portion 112 and the second fixing portion 113 are combined, thereby preventing the electrode contact 11 from being easily removed from the base 12.
In some embodiments, the second fixing portion 113 may also be formed on the first fixing portion 112. Referring to fig. 8, the first fixing portion 112 is disposed annularly, the second fixing portion 113 further includes two fixing holes 1135 disposed on the first fixing portion 112, the first fixing portion 112 has two fixing holes 1135, and the fixing holes 1135 penetrate through the first fixing portion 112 in the direction of the bottom wall 1111. After the first fixing portion 112 is clamped inside the base 12, a portion of the base 12 can penetrate into the fixing hole 1135, so as to improve the connection strength between the first fixing portion 112 and the base 12.
Further, the cross-sectional shape of the fixing holes 1135 may be circular, square, or trapezoidal, the number of the fixing holes 1135 may be plural, and the plural fixing holes 1135 are uniformly distributed in the circumferential direction of the first fixing portion 112, so as to enhance the connection strength between the first fixing portion 112 and the base 12 in the circumferential direction. The fixing hole 1135 and the folded portion may be simultaneously disposed on the first fixing portion 112 as required.
Since the base body 12 itself is relatively flexible, in combination with the characteristics of the base body 12, in combination with fig. 9 to 10, the second fastening portion 113 further includes a recessed portion 1136, and the recessed portion 1136 is provided on the side of the first fastening portion 112 facing the bottom wall and/or the side facing away from the bottom wall. After the first fixing portion 112 is located in the base 12, the base 12 presses the first fixing portion 112, and the concave portion 1136 facilitates forming a negative pressure between the base 12 and the first fixing portion 112. Therefore, not only extrusion fixation and clamping fixation are formed between the electrode contact 11 and the substrate 12, but also adsorption fixation formed by negative pressure is formed, and the possibility that the electrode contact 11 is separated from the substrate 12 is reduced. In the illustration of fig. 9 and 10, the recess is annularly disposed according to the shape of the first fixing portion 112, and in other embodiments, the recess may also be a multi-segment arc structure or a plurality of circular structures.
Further, in the present invention, the second fixing portion 113 may include a recess 1136 and a folded portion (an upper fixing claw 1131, a lower fixing claw 1132, an upper fixing folded edge 1133, or a lower fixing folded edge 1134). After the electrode contact 11 is fixed to the base 12, adsorption fixation, extrusion fixation, and clamping fixation may be formed only between the electrode contact 11 and the base.
Fig. 11 is a schematic view of a multi-lumen protective tube in an embodiment of the present invention. Fig. 12 is a schematic view of a cortical electrode in an embodiment of the invention, with an array of electrode contacts 11 and a connecting terminal in fig. 12. Fig. 13 is a schematic diagram of a skin electrode having two rows of electrode contacts 11 according to an embodiment of the present invention, and fig. 13 has two rows of electrode contacts 11 and one connection terminal. Fig. 14 is another schematic view of a skin electrode having two rows of electrode contacts 11 according to an embodiment of the present invention, and fig. 14 shows two rows of electrode contacts 11 and two connection terminals. Fig. 15 is a schematic diagram of a cortical electrode having two branch segments 141 according to an embodiment of the invention, with fig. 15 having an array of electrode contacts 11 and two connection ends formed by the two branch segments 141.
Referring to fig. 11-15, the cortical electrode provided by the invention includes the electrode contact 11, and the contact part of the electrode contact 11 is used for contacting with the human brain cortical layer and collecting and receiving the electroencephalogram signal.
The cortex electrode further comprises a functional end, an extension section and a connecting end, the functional end comprises a substrate 12, the substrate 12 is sheet-shaped, and at least one electrode contact 11 is installed on the substrate 12. Generally, two or more electrode contacts 11 are mounted on the base 12.
The substrate 12 is made of an implant-grade material such as polyurethane, silicone rubber, polytetrafluoroethylene, or PDMS (polydimethylsiloxane). The substrate 12 is sheet-shaped, generally rectangular, and can also be round, oval, trapezoidal, etc., the size of the substrate 12 can be designed according to the requirements of actual conditions, when the focal region or the monitoring region of the brain is large in area, the substrate 12 can be processed into a rectangular sheet with a large area, and the electrode contacts 11 can also be arranged in two or more rows according to the requirements. When the area of the skin layer to be monitored is small, the base body 12 may be processed into a long strip shape, and the electrode contacts 11 may be arranged in a row and arranged along the length direction of the base body 12.
In other embodiments, the size of the substrate 12 and the number of the electrode contacts 11 are designed according to actual requirements, and the electrode contacts 11 may be arranged linearly. In the present invention, the distance (clear distance) between two adjacent electrode contacts 11 is between 1mm and 15 mm.
The base 12 is internally laid with a reinforcing member (not shown) having a rigidity greater than that of the base 12, and in the embodiment of the present invention, the reinforcing member may be a mesh structure.
In the cortical electrode implantation process, a small wound is formed on the brain, and the cortical electrode is implanted in an insertion mode. The reinforcing piece can improve the ability of bending deformation resistance of the base body 12, so that accurate movement of the cortical electrode is facilitated, and the accuracy of the implanted position of the cortical electrode is improved.
The substrate 12 has a mark built in near the electrode contact 11 for distinguishing the different contacts. The substrate 12 may be configured as a solid structure, or a channel 17 for passing through the lead 13 may be left in the processing process, and the lead 13 is connected to the side of the electrode contact 11 facing away from the skin layer.
The extension includes a protective tube 14, the protective tube 14 is made of polymer material such as polyurethane, silicon rubber or other materials, and the protective tube 14 can be of a single-cavity or multi-cavity structure. As shown in fig. 11, when the protection tube 14 has a multi-lumen structure, it has a central lumen 143 and a peripheral lumen 142 surrounding the central lumen 143, the central lumen 143 can be used for a guide wire to pass through, the guide wire improves the rigidity of the extension section, thereby facilitating the implantation of the cortical electrode into the brain, and the peripheral lumen 142 is used for a guide wire 13 to pass through. The number of peripheral cavities 142 can be designed by those skilled in the art according to the number of electrode contacts 11.
In the embodiment of the invention, one end of the protection tube 14 close to the base body 12 is hermetically connected with the base body 12, and the lead 13 penetrates into the protection tube 14. The wires 13 may be linear or spiral, when the wires 13 are designed spirally, the peripheral cavities 142 extend spirally around the central cavity 143, and the wires 13 penetrate through each peripheral cavity 142, so that the plurality of wires 13 extend spirally around the central cavity 143, and the mechanical property and flexibility of the wires 13 located in the extension section are improved. A shielding layer can be added in the protective tube 14 to improve the nuclear magnetic compatibility. As shown in fig. 12, a protective sleeve 144 may be further disposed at a connection position of the protective tube 14 and the base body 12, the protective tube 14 is inserted into the protective sleeve 144, an outer side wall of the protective tube 14 is hermetically connected with an inner side wall of the protective sleeve 144, a part of the protective sleeve 144 is located in the base body 12, and another part of the protective sleeve 144 is located outside the base body 12, so as to improve a connection strength between the protective tube 14 and the base body 12.
As shown in fig. 12 to 13, the connection terminal includes an insulating portion 16 and a connection contact 15 mounted on the insulating portion 16, and the connection contact 15 is connected to the lead wire 13 drawn out from the protective tube 14. The connecting ends are used for being connected with a stimulator, the adjacent connecting contacts 15 are arranged in an insulating mode through insulating parts 16, and polymer materials can be selectively filled in the connecting ends or catheters, springs, rods and the like can be installed in the connecting ends, so that the rigidity of the connecting ends is improved. The attachment end also has a through hole for communicating with the central lumen 143 to facilitate passage of a guidewire into the central lumen 143.
Further, the cortical electrode is also provided with a mark structure, and the mark structure can be a ring with a color different from that of the protective tube 14 and the insulating part 16, or a local color block. In fig. 12, the connection terminals are provided with contact marks 18 for each connection contact 15, and the protective tube 14 is provided with an assembly mark 19 adjacent to the connection terminals. The assembly mark 19 is used for observing whether the connecting end is assembled in place with the stimulator, the contact mark 18 is used for observing the position of each connecting contact 15, the assembly mark 19 can be metal or high polymer material which can be implanted into a human body, the contact mark 18 is made of insulating high polymer material, and the conducting wire 13 is prevented from being short-circuited with the stimulator through the contact mark 18.
In other embodiments, the assembling mark 19 may also be disposed on the side of the connection end near the protection tube 14 according to the length of the connection end, and the position of the assembling mark 19 is mainly for easy observation.
It will be appreciated that the extension is defined as the portion of the substrate 12 between the connection ends, the portion of the wire having a helical configuration to increase the flexibility of the extension.
One end of the wire 13 is connected to the connection contact 15, and the wire 13 connected to the connection contact 15 is fitted into the protective tube 14. And the electrode contact 11 of the functional end is connected with the lead 13, and the substrate 12 is molded by the process modes of mould pressing, glue injection, injection molding and the like, so that the electrode is manufactured. The electrode manufacturing sequence can be adjusted.
When the electrode contacts 11 are arranged in a plurality of rows, each row of the electrode contacts 11 can be correspondingly provided with a protective tube 14. As shown in fig. 14, the electrode contacts 11 are provided in two rows, and the protection tube 14 is provided in two rows to form two connection terminals.
The protection tube 14 may also be provided with one, two or more branch tube sections 141, and the wires 13 connected to different electrode contacts 11 are grouped according to requirements, and each group of wires 13 is led out from different branch tube sections 141. As shown in fig. 15, the electrode contacts 11 are arranged in a row, the base body 12 is connected to a protective tube 14, and the protective tube 14 is provided with two branch tube sections 141, forming two connection ends.
It should be noted that, in the present invention, a mounting groove is disposed on a side of the base 12 contacting the cortex, the mounting groove is in snap fit with the first fixing portion 112, and the mounting groove is slightly smaller than the first fixing portion 112, so that the first fixing portion 112 is squeezed by the base 12. The second fixing portion 113 of the electrode contact 11 has various forms, and the fitting portion in the base 12 may be provided correspondingly to the form of the second fixing portion 113.
Specifically, the method comprises the following steps:
a. the second fixing portion 113 includes a lower fixing claw 1132, and the fitting portion includes a lower engaging groove (a side of the substrate 12 facing the skin layer may be defined as a lower side, and vice versa as an upper side) communicating with the mounting groove, the lower engaging groove having a shape matching the shape of the lower fixing claw 1132;
b. the second fixing portion 113 includes an upper fixing claw 1131, the fitting portion includes an upper engaging groove communicated with the mounting groove, and the upper engaging groove is adapted to the shape of the upper fixing claw 1131;
c. the second fixing portion 113 includes an upper fixing claw 1131 and a lower fixing claw 1132, and the fitting portion includes an upper card slot and a lower card slot communicated with the mounting groove;
d. the second fixing portion 113 includes an upper fixing flange 1133, the fitting portion includes an upper groove communicated with the mounting groove, when the first fixing portion 112 is annular, the second fixing portion 113 is also annular, and the upper groove is correspondingly configured to be annular;
e. the second fixing portion 113 includes a lower fixing flange 1134, the mating portion includes a lower groove communicated with the mounting groove, when the first fixing portion 112 is annular, the second fixing portion 113 is also annular, and the lower groove is correspondingly configured to be annular;
f. the second fixing portion 113 includes a fixing hole 1135, the matching portion includes a connecting column disposed in the mounting groove, and the connecting column can penetrate through the fixing hole 1135.
The mounting groove has a cross-sectional shape in the thickness direction of the base body 12 of approximately "T" shape, and in the foregoing, a net-shaped reinforcing member may be laid in the base body 12. Therefore, it is possible to provide a reinforcement member in the corresponding base body 12 below the first fixing portion 112, or to increase the laying density of the reinforcement member, that is, to emphasize the rigidity of the base body 12 on the peripheral side of the first fixing portion 112, thereby avoiding the electrode contacts 11 from coming off the base body 12.
The invention also provides an implantable medical device, which comprises a stimulator, a deep brain electrode and a cortical electrode, wherein the deep brain electrode and the cortical electrode are respectively connected with the stimulator, the deep brain electrode can monitor deep brain electric signals and output stimulation current, and the cortical electrode can monitor deep brain electric signals and output stimulation current.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. An electrode contact, comprising:
a contact part (111) having a bottom wall (1111) and a side wall (1112) connecting the bottom wall (1111), wherein the height of the contact part (111) in the thickness direction of the electrode contact is H 1 The maximum length of the projection shape of the contact point contact part (111) in the thickness direction is D;
a first fixing portion (112) connected to the side wall (1112) and protruding from an outer wall surface of the side wall (1112); and
a second fixing portion (113) provided on the first fixing portion (112) and/or the side wall (1112) and extending in the electrode contact thickness direction, wherein the height of the second fixing portion (113) in the electrode contact thickness direction is H 2 ；
Wherein the first fixing part (112) and the second fixing part (113) are respectively used for connecting with the substrate (12), and H is more than or equal to 0.1D 1 ≤0.5D，0.5H 1 ≤H 2 ＜H 1 。
2. The electrode contact of claim 1, wherein the H is 2 The value range of (A) is not less than 0.05mm and not more than H 2 ＜5mm。
3. The electrode contact according to claim 1, wherein the first fixing portion (112) and the second fixing portion (113), the first fixing portion (112) and the side wall (1112), and the side wall (1112) and the bottom wall (1111) are formed by integral processing;
the side wall (1112) is surrounded to form a hollow cylindrical structure, the bottom wall (1111) is positioned on one axial side of the side wall (1112), the first fixing part (112) is annularly arranged on the other axial side of the side wall (1112), and the first fixing part (112) is circumferentially provided with a plurality of second fixing parts (113);
the bottom wall (1111) is circular in shape in the thickness direction, the diameter of the circle is equal to D, and the width of the first fixing portion (112) is W, so that W is more than or equal to 0.2D and less than or equal to 0.5D.
4. The electrode contact according to claim 1, wherein the second fixing portion (113) comprises a folded portion extending in a thickness direction of the electrode contact, the folded portion being located at an outer edge of the first fixing portion (112) away from the side wall (1112).
5. The electrode contact as claimed in claim 4, wherein the folded portion is curved in an arc shape or bent in an arc shape in multiple sections, the length of the folded portion in the vertical thickness direction is L, and the thickness of the folded portion is T, so that L is greater than or equal to 2T and less than or equal to 3T.
6. The electrode contact as claimed in claim 4, wherein the folded portion is curved in an arc shape or bent in an arc shape in multiple sections, the length of the folded portion in the vertical thickness direction is L, L is greater than or equal to 0.2mm and less than or equal to 2mm, the thickness of the folded portion is T, and T is greater than or equal to 0.1mm and less than or equal to 0.8mm.
7. A sheath electrode, comprising a base body (12) and an electrode contact (11) according to any one of claims 1 to 6;
the base body (12) is mounted with a plurality of the electrode contacts (11).
8. The skin electrode according to claim 7, wherein the spacing between two adjacent electrode contacts (11) is 1mm-15mm;
and a reinforcing piece is paved in the base body (12), and the rigidity of the reinforcing piece is greater than that of the base body (12).
9. The skin electrode according to claim 8, wherein the side of the substrate (12) for contacting the skin has a mounting groove, and a fitting part is arranged in the mounting groove;
the first fixing portion (112) is clamped in the mounting groove, the contact portion (111) is located outside the base body (12), and the second fixing portion (113) is connected with the matching portion.
10. An implantable medical device comprising the cortical electrode of any of claims 7-9.
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| CN115633964B (en) | 2023-03-03 |
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Address after: 102200 building 19, yard 79, Shuangying West Road, science and Technology Park, Changping District, Beijing Patentee after: Beijing Pinchi Medical Equipment Co.,Ltd. Country or region after: China Address before: 102200 building 19, yard 79, Shuangying West Road, science and Technology Park, Changping District, Beijing Patentee before: BEIJING PINS MEDICAL Co.,Ltd. Country or region before: China |