CN114377291A

CN114377291A - Electrode protection device

Info

Publication number: CN114377291A
Application number: CN202011118906.5A
Authority: CN
Inventors: 王晓凯; 唐龙军; 何庆; 张明
Original assignee: Shanghai Shenyi Medical Technology Co ltd
Current assignee: Shanghai Shenyi Medical Technology Co ltd
Priority date: 2020-10-19
Filing date: 2020-10-19
Publication date: 2022-04-22

Abstract

The invention provides an electrode protection device, which comprises a shell, at least one convex ring and a limiting structure, wherein the shell is provided with a plurality of convex rings; the shell is provided with a cavity with an open far end, and the cavity is used for the penetration of an electrode; the convex ring is arranged on the inner side wall of the shell along the circumferential direction of the shell, and the convex ring is configured to deform when the electrode is arranged in the cavity in a penetrating manner so as to isolate the conductive ring of the electrode; the limiting structure is arranged on the outer side wall of the distal end of the shell and is used for limiting the displacement of the surgical cable tied on the shell in the axial direction of the shell. Compared with the traditional electrode protection device, the electrode protection device provided by the invention has the advantages of simple parts, simplicity and convenience in operation and capability of effectively shortening the operation time.

Description

Electrode protection device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an electrode protection device.

Background

Parkinson's disease is a common nervous system degenerative disease, and is common in the elderly, with an average onset age of about 60 years. The most important pathological change of Parkinson's disease is the degenerative death of mesencephalic nigral Dopamine (DA) neurons, which causes a marked reduction in striatal DA content and causes disease. Parkinson's disease mainly presents with resting tremor, bradykinesia, gait disturbance of posture and the like, which can cause great influence on the life of patients.

With the development of modern medical science and technology, the Parkinson's disease can be effectively improved by stimulating the subthalamic nucleus or the internal nucleus of the globus pallidus by using the electrodes. The DBS (deep brain stimulation) system used is shown in fig. 1 and comprises a pulse generator (generally abbreviated IPG)1, extension leads 2, electrodes 3, extension leads 4, electrodes 5 (two extension leads and two electrodes are required for bilateral stimulation). One end of the electrode 3 is implanted into the brain by about 10cm, the rest is embedded under the skin of the head, the other end is placed behind the ear and connected with a subcutaneous extension lead 2, and the extension lead 2 is connected with the pulse generator 1. The pulse generator 1 generates an electrical signal that is transmitted to the electrodes 3 via the subcutaneous extension leads 2 to the target area of the brain.

In the operation process, the confirmation of the brain target point is very critical, and after the electrode is implanted, CT or MR scanning is needed to confirm whether the implantation position of the electrode is accurate. Before scanning, the electrodes are sealed and protected, buried under scalp, and then the scalp is sutured. The conventional operation is shown in fig. 2: 1. the electrode sheath 6 is fitted over the electrode 3. 2. The electrode cap 7 is fitted over the electrode 3. 3. The electrode cap 7 is locked to the electrode using a fastening screw 8 to lock into a part screw fixing block 71 in the electrode cap 7. 4. The electrode protecting sleeve 6 is reversely sleeved on the electrode cap 7. 5. The two ends of the electrode protective sleeve are tied tightly by using the operation wire 9, so that the electrode is protected and sealed.

As can be seen from the above description, the electrode cap needs to function as a protection and sealing device for the electrode, and the conventional electrode protection device has many parts, which will have the following adverse effects:

1. the conventional electrode protection device has large part size, and increases the discomfort of a patient after being buried under the skin;

2. the electrode protection device has many parts and complex operation, which undoubtedly prolongs the operation time to a certain extent;

3. the electrode cap is locked on the electrode by the fastening screw which is made of metal and has high hardness, and the electrode can be damaged in the screwing process.

Disclosure of Invention

It is an object of the present invention to provide an electrode protection device that solves one or more problems of the prior art.

To solve the above technical problem, the present invention provides an electrode protection device, including:

the shell is provided with a cavity with a far end opened, and the cavity is used for the penetration of an electrode;

the convex ring is arranged on the wall of the cavity of the shell along the circumferential direction of the shell and is configured to deform when the electrode is arranged in the cavity so as to isolate the conductive ring of the electrode; and the number of the first and second groups,

the limiting structure is arranged on the outer side wall of the far end of the shell and used for limiting the displacement of the surgical cable bound on the shell in the axial direction of the shell.

Optionally, in the electrode protection device, the housing includes a polymer layer forming a wall of the cavity, and a support layer, and the support layer is encapsulated in the polymer layer or located outside the polymer layer.

Optionally, in the electrode protection device, an axial length of the support layer is smaller than an axial length of the cavity.

Optionally, in the electrode protection device, the support layer is made of a metal mesh grid or a laser-cut metal tube.

Optionally, in the electrode protection device, the limiting structure includes: the surgical suture line comprises a casing, at least two limiting parts which are distributed on the casing in the axial direction at intervals, wherein the at least two limiting parts protrude out of the casing, and a binding region of the surgical suture line is formed in a region between the two limiting parts.

Optionally, in the electrode protection device, the limiting member is a limiting ring disposed along a circumferential direction of the housing; or each limiting part comprises at least two limiting tables, and at least two limiting tables of each limiting part are uniformly distributed along the circumferential direction.

Optionally, in the electrode protection device, the limiting structure is a recessed portion formed along the circumferential direction of the housing, and a bundling region of the surgical cable is formed in a region where the recessed portion is located.

Optionally, in the electrode protection device, an outer diameter of the housing is 2.5mm to 3.2 mm.

The present invention also provides another electrode protection device, comprising:

the housing includes a polymer layer forming a cavity wall and a support layer encapsulated in or outside the polymer layer.

Optionally, in the other electrode protection device, an axial length of the support layer is smaller than an axial length of the cavity.

Optionally, in the other electrode protection device, the polymer layer includes at least one convex ring arranged along the circumferential direction of the cavity wall.

Optionally, in the other electrode protection device, the support layer is made of a metal woven mesh or a laser-cut metal tube.

In summary, in the electrode protection device provided by the present invention, the electrode protection device includes a housing, at least one protruding ring and a limiting structure; the shell is provided with a cavity with an open far end, and the cavity is used for the penetration of an electrode; the convex ring is arranged on the wall of the cavity of the shell along the circumferential direction of the shell, and the convex ring is configured to deform when the electrode is arranged in the cavity in a penetrating manner so as to isolate the conductive ring of the electrode; the limiting structure is arranged on the outer side wall of the distal end of the shell and is used for limiting the displacement of the surgical cable tied on the shell in the axial direction of the shell. When the electrode protection device is used for sealing an electrode, the electrode is directly inserted into the shell, the electrode protection sleeve does not need to be sleeved on the electrode in advance, the electrode protection sleeve is reversely sleeved on the electrode cap to prevent water, but the electrode protection sleeve can prevent water through a convex ring which is arranged on the wall of a cavity of the shell and can deform, so that the whole diameter of the electrode protection device can be reduced, in addition, a complex thread fixing block structure is abandoned, a limiting structure is arranged on the shell, the relative position of the electrode and the shell is fixed by directly bundling an operation line, therefore, the whole size can be further reduced, the electrode can be prevented from being damaged, meanwhile, a patient is difficult to feel uncomfortable when using the electrode protection device, compared with the traditional electrode protection device, the electrode protection device is simple in part, simple and convenient to operate, and the operation time can be effectively shortened.

In another electrode protection device provided by the present invention, the electrode protection device includes: the shell is provided with a cavity with a far end opened, and the cavity is used for the penetration of an electrode; the housing includes a polymer layer forming a cavity wall and a support layer encapsulated in or outside the polymer layer. When the electrode protection device is used for sealing the electrode, the electrode is directly inserted into the shell, the electrode protective sleeve does not need to be sleeved on the electrode in advance, the electrode protective sleeve is reversely sleeved on the electrode cap to prevent water, the shell is directly tied up to prevent water, the relative position of the electrode and the shell is fixed, and meanwhile, the deformation of the polymer layer in the circumferential direction and the overall strength of the shell can be reduced through the supporting layer, so that the outer diameter of the shell can be reduced under the condition that the target tension is the same. Compared with the traditional electrode protection device, the electrode protection device has simple parts and simple and convenient operation, and can effectively shorten the operation time.

Drawings

FIG. 1 is a schematic diagram of a DBS system in the present invention;

FIG. 2 is a schematic diagram of a conventional operation of sealing an electrode according to the present invention;

fig. 3 is a schematic perspective view of an electrode protection device according to an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of an electrode protection apparatus according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of an operation process of an electrode protection apparatus according to an embodiment of the present invention;

FIG. 6 is a perspective view of an electrode protection device according to an embodiment of the present invention;

fig. 7 is a schematic structural diagram of a supporting layer provided in the embodiment of the present invention;

fig. 8 is another schematic structural diagram of a supporting layer according to an embodiment of the present invention;

wherein the reference numerals are as follows:

1-a pulse generator; 2-extension wire; 3-an electrode; 4-extension wire; 5-an electrode; 6-electrode protection sleeve; 7-electrode cap; 8-a fastening screw; 9-surgical thread; 70-one end of the electrode cap; 71-a threaded fixing block;

100-electrode protection device; 200-electrodes; 300-a surgical line; 11-a housing; 101-a cavity; 12(121, 122, 123, 124) -male ring; 13-a limit structure; 102-a bundling area; 131-a first stop collar; 132-a second stop collar; 111-a polymer layer; 112-a support layer; 103-closed end.

Detailed Description

As mentioned above, before confirming whether the implantation position is accurate, the electrode needs to seal and protect the end of the non-implanted target object. The conventional electrode protection device is large in size, numerous in parts, cumbersome to operate and the fastening screw locking may damage the electrode.

In view of the limitations of the conventional electrode protection devices, the present invention provides an electrode protection device, which has the characteristics of less parts, simple operation and no damage to the electrode.

The electrode protection device according to the present invention will be described in further detail with reference to the accompanying drawings and specific examples. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

Also, as used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" is generally employed in a sense including "and/or," the terms "a," "an," and "the" are generally employed in a sense including "at least one," the terms "at least two" are generally employed in a sense including "two or more," and furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first", "second" or "third" may explicitly or implicitly include one or at least two of the features, the term "proximal" generally being the end near the operator, the term "distal" generally being the end near the object being manipulated, the terms "end" and "other end" and "proximal" and "distal" generally referring to the corresponding two parts, which include not only the end points. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

[ EXAMPLES one ]

Referring to fig. 3 in combination with fig. 4, the present embodiment provides an electrode protection apparatus 100, where the electrode protection apparatus 100 includes:

the electrode assembly comprises a shell 11, wherein the shell 11 is provided with a cavity 101 with a far end opened, and the cavity 101 is used for allowing an electrode 200 to penetrate through;

at least one convex ring 12, wherein the convex ring 12 is disposed on the cavity wall of the housing 11 along the circumferential direction of the housing 11, and the convex ring 12 is configured to deform when the electrode 200 is disposed in the cavity 101, so as to isolate the conductive ring of the electrode 200; and the number of the first and second groups,

a limiting structure 13, wherein the limiting structure 13 is disposed on an outer side wall of the distal end of the housing 11, and the limiting structure 13 is used for limiting the displacement of the surgical cable tied on the housing 11 in the axial direction of the housing 11.

Generally, the electrode includes a plurality of electrode rings distributed at intervals along the axial direction, and with the electrode protection apparatus 100 provided in this embodiment, as shown in fig. 5, an electrode 200 is inserted into the cavity 101 of the housing 11 from the distal end (open end) of the housing 11 of the electrode protection apparatus 100, after the electrode 200 is inserted into the cavity 101, because the inner diameter of the convex ring 12 is smaller than the diameter of the electrode 200, the convex ring 12 deforms, and then is inserted into a gap between adjacent conductive rings of the electrode 200 or a gap between a conductive ring and other parts of the electrode 200 to isolate the conductive rings of the electrode, so as to achieve water resistance, after the electrode 200 abuts against the proximal end (closed end 103) of the housing 11, a surgical cable is tied up in the area where the position-limiting structure 13 is located or the area defined by the position-limiting structure 13, to define the relative position of the electrode 200 with respect to said housing 11.

Therefore, the electrode protection device 100 provided by the embodiment does not adopt the electrode protection sleeve to be reversely sleeved on the electrode cap and tied up with the operation wire for water prevention, but directly arranges the deformable convex ring 12 on the cavity wall of the shell 11, and performs water prevention through the convex ring 12, so when the electrode protection device 100 provided by the invention is used for sealing the electrode, the electrode is inserted into the shell 11, the electrode protection sleeve does not need to be sleeved on the electrode in advance, the whole diameter of the electrode protection device is reduced, in addition, a complex thread fixing block structure is abandoned, the limiting structure 13 is arranged on the shell, the relative position of the electrode and the shell is fixed by directly tying up with the operation wire, therefore, the whole size can be further reduced, the electrode can be prevented from being damaged, and simultaneously, discomfort is not easily generated when a patient uses the electrode protection device, compared with the traditional electrode protection device, the parts are simple, the operation is simple and convenient, and the operation time can be effectively shortened.

Optionally, the limiting structure 13 includes: at least two limiting pieces are distributed at intervals in the axial direction of the shell 11, each limiting piece protrudes outwards from the shell 11, and the area between the two limiting pieces forms a bundling area 102 of the surgical cable. Since the stoppers protrude outward from the housing 11, when the surgical wire is tied between the stoppers, the displacement of the surgical wire in the axial direction of the housing 11 is restricted, and thus the relative movement of the electrode and the housing 11 can be prevented.

Further, in this embodiment, as shown in fig. 3, the limiting member may be a limiting ring disposed along the circumferential direction of the housing 11, and the number of the limiting rings is 2. The axial cross section of the limiting ring can be square, semicircular or other suitable shapes, and the application is not limited in this respect.

In other embodiments, each of the limiting members includes at least two limiting tables, and at least two of the limiting tables of each of the limiting members are uniformly distributed along the circumferential direction, and an annular bundling region is formed between two adjacent limiting members for bundling the surgical cable, thereby limiting the movement of the surgical cable in the axial direction of the housing 11. The cross section of the limiting table can be circular, square, hexagonal or other suitable shapes, and the application is not limited to this.

In addition, the limiting structure 13 may further include one limiting ring and a plurality of limiting tables, wherein the plurality of limiting tables are arranged along the circumferential direction of the housing 11, and the area between the plurality of limiting tables and the limiting ring forms a bundling area 102 of the surgical cable.

The size of the stop collar and the stop table may be set according to the diameter of a commonly used surgical cable. Typically, the height of the stop collar and the stop boss protruding from the housing 11 is at least no less than the diameter of the surgical cable to be bundled.

Optionally, the limiting structure 13 is a recessed portion formed along the circumferential direction of the housing 11, and the region where the recessed portion is located forms a bundling region 102 of the surgical cable. The number of the recessed portions may be one or more, and when the number of the recessed portions is plural, the plurality of recessed portions are sequentially arranged along the axial direction of the housing 11. Also, the depth and width of the recess are at least not less than the diameter of the surgical thread to be bundled.

The specific number of the convex rings 12 can be set according to actual use scenes. In the present embodiment, preferably, the number of the convex rings 12 is greater than the number of the conductive rings of the electrodes, for example, as shown in fig. 4, two conductive rings of the electrodes are respectively the conductive ring 201 and the conductive ring 202, so the number of the convex rings can be set to three, including: the conductive ring 201 is isolated by the convex ring 122 and the convex ring 123, and the conductive ring 202 is isolated by the convex ring 123 and the convex ring 124, so that the conductive ring 201 and the conductive ring 202 are waterproof, and the problem that the whole electrode fails due to liquid conduction between the conductive ring 201 and the conductive ring 202 is avoided. Further preferably, at least one protruding ring 12 is disposed on one side of the limiting member away from the axis of the housing 11, so as to initially prevent the electrode 200 from being water-tight.

The housing 11 may only include a polymer layer 111 forming a cavity wall, and the polymer layer 111 is made of a polymer material such as polyurethane and silicone. In this embodiment, as shown in fig. 6, preferably, the housing 11 further includes a support layer 112 in addition to the polymer layer 111 forming the cavity wall, the support layer 112 is encapsulated in the polymer layer 111 or located outside the polymer layer 111, and when the support layer 112 is encapsulated in the polymer layer 111, the support layer may be formed by a two-shot injection molding method.

The support layer 112 provides tension for the polymer layer 111 and increases the overall strength of the housing 11, after the electrode is inserted, the polymer layer 111 is easily deformed in the circumferential direction, which may affect the waterproof effect, and the deformation of the polymer layer 111 may be reduced and the overall strength of the housing 11 may be increased by increasing the support layer 112. As shown in fig. 7, the support layer 112 may be woven from a hard and fatigue-resistant metal material, such as stainless steel, nitinol, and the like, and as shown in fig. 8, the support layer 112 may also be formed from a metal tube, such as stainless steel, nitinol, and the like, by laser cutting.

In this embodiment, the axial length of the supporting layer 21 is smaller than the axial length of the cavity 101, so that an operator can recognize whether the electrode 200 is located at a predetermined position, and further ensure that the plurality of protruding rings 12 are located at predetermined positions, so that the conductive rings of the electrode 200 are isolated.

Like the polymer layer, the protruding ring 12 may also be made of polyurethane, silica gel, or other materials. For convenience of processing, the housing 11, the protruding ring 12 and the limiting structure 13 may be integrally formed when forming the electrode protection device.

Fig. 4 is a schematic cross-sectional view illustrating an exemplary electrode protection device according to the present embodiment. As shown in fig. 4, the housing 11 includes a polymer layer 111 and a supporting layer 112, the supporting layer 112 is enclosed in the polymer layer 111, the limiting structure 13 includes a first limiting ring 131 and a second limiting ring 132, since the target electrode 200 includes a conductive ring 201 and a conductive ring 202, the number of the convex rings 12 is 4, the 4 convex rings 12 are sequentially arranged along the axial direction of the housing 11, one convex ring 121 is located on one side of the first limiting ring 131 and the second limiting ring 132 away from the axial center of the housing 11, and the other three

convex rings

122, 123, and 124 are located on one side of the first limiting ring 131 and the second limiting ring 132 close to the axial center of the housing 11, and are used for isolating the conductive rings 201 and the conductive rings 202 of the target electrode.

Wherein, the unilateral wall thickness of the polymer layer 111 can be designed to be only 0.5-0.8mm because the overall strength of the shell 11 is improved by the support layer 112. In addition, depending on the size of the target electrode, other dimensions of the electrode protection device 100 may be designed as follows: the outer diameter of the shell 11 is 2.5-3.2mm, the inner diameter is 1.4-1.5mm, the length of the shell 11 body is 31-33mm, the length of the protection head part 112 (closed end) is 3-5mm, the distance between the first limiting ring and the second limiting ring is 0.6-1 mm, the inner diameter of each convex ring 12 is 0.8-1.0mm, and the axial width is 0.4-0.6 mm.

While the conventional electrode protector has an outer diameter of 5-6mm, as can be seen from the above example, the electrode protector 100 of the present embodiment may have an outer diameter of 2.5-3.2mm, and thus it can be seen that the electrode protector 100 of the present embodiment is reduced in size relative to the prior art, thereby reducing discomfort to a patient during use.

It should be noted that the electrode protection device 100 provided in this embodiment is not limited to be used with DBS electrodes, and similar implantable extension leads such as spinal nerve stimulation, vagus nerve stimulation, etc. may be used.

[ example two ]

Referring to fig. 4 in combination with fig. 6, the present embodiment provides another electrode protection device, including:

the electrode assembly comprises a shell 11, wherein the shell 11 is provided with a cavity 101 with a far end opened, and the cavity 101 is used for allowing an electrode 200 to penetrate through; the housing 11 includes a polymer layer 111 forming a cavity wall and a support layer 112, and the support layer 112 is encapsulated in the polymer layer 111 or located outside the polymer layer 111.

The electrode protection device provided by this embodiment adopts the combination of the polymer layer 111 and the support layer 112, after the electrode is inserted into the housing, the electrode can be tied to the tail of the housing 11 by a surgical thread to achieve the waterproof of the electrode, meanwhile, the support layer 111 can reduce the deformation of the polymer layer 111 in the circumferential direction and increase the overall strength of the housing, and under the condition of the same target tension, the outer diameter of the housing 11 can be reduced.

The related arrangement of the supporting layer is the same as that in the first embodiment, and details are not repeated in this embodiment.

In addition, in this embodiment, the polymer layer may further include at least one protruding ring disposed along the circumferential direction of the cavity wall, and the specific arrangement of the protruding ring is the same as that in the first embodiment, which is not described again in this embodiment.

The arrangement of the convex ring can enable the electrode protection device to be waterproof to the electrode without depending on bundling, and the waterproof performance can be further improved through the convex ring.

In summary, compared with the prior art, the electrode protection device provided by the invention has the following beneficial effects:

(1) compared with the traditional electrode protection device, the electrode protection device has simple parts and simple and convenient operation, and can effectively shorten the operation time. Secondly, the electrode protection device is small in size, and a patient does not feel uncomfortable when using the electrode protection device;

(2) the traditional electrode protection device needs to lock the electrode protection device on the electrode by adopting a fastening screw, and the hard fastening screw can damage the electrode;

(3) the electrode protection device provided by the invention has the advantages of simple structure and accessories, convenience in processing and capability of effectively reducing the production and process cost.

It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, similar parts between the embodiments may be referred to each other, and different parts between the embodiments may also be used in combination with each other, which is not limited by the present invention.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims

1. An electrode protection device, comprising:

and the limiting structure is arranged on the outer side wall of the far end of the shell.

2. The electrode protection device of claim 1, wherein the housing comprises a polymer layer forming a cavity wall and a support layer encapsulated in or external to the polymer layer.

3. The electrode protection device of claim 2, wherein the axial length of the support layer is less than the axial length of the cavity.

4. The electrode protection device of claim 2, wherein the support layer is made of a woven metal mesh or a laser cut metal tube.

5. The electrode protection device of claim 1, wherein the retaining structure comprises: the axial of casing is in two at least locating parts of interval distribution, and two at least the locating part is outwards protruding in the casing.

6. The electrode protection device of claim 5, wherein the retaining member is a retaining ring disposed along a circumferential direction of the housing; or each limiting part comprises at least two limiting tables, and at least two limiting tables of each limiting part are uniformly distributed along the circumferential direction.

7. The electrode protection device of claim 1, wherein the retention structure is a recess formed along a circumferential direction of the housing.

8. The electrode protection device of claim 1, wherein the housing has an outer diameter of 2.5mm to 3.2 mm.

9. An electrode protection device, comprising:

10. The electrode protection device of claim 9, wherein the axial length of the support layer is less than the axial length of the cavity.

11. The electrode protection device of claim 9, wherein the polymer layer comprises at least one torus disposed along a circumference of the cavity wall.

12. The electrode protection device of claim 9, wherein the support layer is made of a woven metal mesh or a laser cut metal tube.