CN115721858A - Implantable nerve stimulation device - Google Patents

Abstract

The invention relates to the field of electrical stimulation therapy medical instruments, in particular to an implanted nerve stimulation device, which can effectively limit a lead in a guide groove according to a limiting structure of a winding part of the device, and particularly relates to a local limiting mode.

Description

Implantable nerve stimulation device

Technical Field

The invention relates to the field of medical appliances for electrical stimulation therapy, in particular to an implantable nerve stimulation device.

Background

An implantable neurostimulator is a method for stimulating target nerves with a certain degree of current pulses to adjust or restore the function of the brain, nerves or muscles, so as to relieve symptoms. Clinically, many neurological diseases or mental diseases lack an effective radical treatment method, most treatment modes require patients to take medicines for a long time or even for a lifetime, and a certain proportion of patients take medicines for a long time to generate serious side effects, so that the implanted nerve stimulator can become a replacement therapy. Currently, there are areas of neuromodulation applications using implantable neurostimulators, mainly Deep Brain Stimulation (DBS), vagus Nerve Stimulation (VNS), spinal (SCS) and Sacral (SNM), tibial (TNS), and the diseases treated include: parkinson, epilepsy, pain, urinary retention, and the like.

The implantable neurostimulator generally comprises an implantable pulse generator and a stimulation electrode, wherein the implantable pulse generator is used for outputting electric pulses according to the programmed parameters set by a doctor, and the electrode is used for transmitting the electric pulses to target nerves. Extension leads are often used for the transition if the two are located at a relatively large distance from the subcutaneous implantation site of the patient.

In the actual operation process, due to individual differences of patients, distances between electrode implantation positions (target nerve positions) of different patients and the position of the implantable pulse generator may be greatly different, when the electrode lead passes through the subcutaneous tunnel 12 and is connected with the implantable pulse generator after the electrode implantation is completed, the electrode lead is short in length and long in length, the electrode lead is designed to be longer when the electrode lead is designed, and the extra part of the electrode lead in length is coiled around the pulse generator for a circle and then placed in a pre-made bag 4 (as shown in fig. 1-3) when the implantable pulse generator is implanted.

However, the pulse generator is only limited by the size of the capsular bag 4 in the capsular bag 4, in most cases, the position of the pulse generator will be shifted, the shifted pulse generator will affect the layout of the leads on the surface of the pulse generator, and therefore, the leads may be entangled, or the leads may be dislocated and moved to the surface of the pulse generator due to the loose skin of the patient during the actual operation and after long-term implantation; particularly in the case of the former winding, failure is extremely likely to occur in the following cases:

1. when the limbs of a patient are stretched and twisted, the joint of the electrode lead and the pulse generator and the fixed position of the stimulating end of the electrode generate larger stress, the electrode is dislocated due to the failure of the fixation of the electrode, the connection of the joint of the electrode pulse generator is interrupted, or the electrode lead is broken.

2. The electrode lead is dislocated on the surface of the pulse generator, an electrode-shaped bulge appears on the skin surface of the implanted position of the pulse generator, the electrode can be damaged by the actions of sleeping and turning over, bathing and the like in daily life of a patient, and tearing pain or subcutaneous bleeding can be easily caused.

Disclosure of Invention

In order to solve the above problems, the present invention provides an implantable neurostimulation device, which is used for fixing a lead, limiting the moving range of the lead, and effectively preventing faults caused by the lead.

In order to achieve the purpose, the invention adopts the technical scheme that: an implantable neurostimulation device, comprising:

a winding part, wherein an electrode stimulation end is arranged at the tail end of a lead of the winding part, and the electrode stimulation end is conducted by a feed-through assembly in the winding part;

the peripheral face of the winding portion is provided with a plurality of guide grooves, the inner faces of the guide grooves are provided with limiting structures, and the wires in the guide grooves can be limited in partial areas in the guide grooves under the action of the limiting structures, and the rest parts can protrude outwards from the guide grooves to form an arc shape.

According to the implantable nerve stimulation device, the lead can be effectively limited in the guide groove according to the limiting structure of the winding part of the implantable nerve stimulation device, particularly in a local limiting mode, part of the area of the lead can be withdrawn from the guide groove, and the rest part of the lead is retained in the guide groove due to the limiting structure, so that the situation that the electrode lead is wound or misplaced is avoided.

Drawings

FIG. 1 is a block diagram of the present invention.

Fig. 2 is an exploded view of the pulse generator.

Fig. 3 is a cross-sectional view of the pulse generator.

Fig. 4 is a side view of the headpiece connector.

Fig. 5 is a structural view of the housing.

Fig. 6 is a schematic view of an electrode lead implantation procedure.

Fig. 7 is a schematic illustration of making a subcutaneous pocket.

Fig. 8 is a schematic diagram of the connection of the electrode lead to the temporary pacemaker.

Fig. 9 is a schematic diagram of the connection of the electrode leads to the pulse generator.

Fig. 10 is a schematic view of the electrode lead receiving.

Fig. 11 is a schematic view of the pulse generator implanted in a subcutaneous pocket.

Description of the drawing reference numerals: 1-electrode stimulation end; 2-a pulse generator; 3-a feedthrough assembly; 4-a pouch;

5-a headpiece connector; 6-a shell; 7-a guide groove; 8-a projection; 9-a jack; 10-a fixing member;

11-a limiting structure; 12-a subcutaneous tunnel; 13-temporary pacemaker.

Detailed Description

As shown in fig. 1, the implantable neurostimulation device of the invention comprises two parts, namely an electrode stimulation end 1 and a pulse generator 2, wherein the shell of the pulse generator 2 is a winding part, an electrode lead in the winding part is led out from the inside of the pulse generator 2, and the led-out part is electrically connected with the electrode stimulation end 1.

As shown in fig. 2, the pulse generator 2 includes a battery, a feed-through component 3, and a PCBA, the electrical energy on the battery can conduct the PCBA, and the pulse forming part on the PCBA outputs a specified pulse signal, which is transmitted to the electrode stimulation end 1 through the feed-through component 3, so as to perform electrical stimulation treatment on the target nerve.

In performing the procedure, a bladder 4 is installed in the subcutaneous region of the patient, and the pulse generator 2 is installed in the bladder 4.

The winding part is composed of the following structures:

the winding part consists of a head connector 5 and a shell 6, the head connector 5 is fixed at the upper end of the shell 6, the formed winding part is approximately rectangular, a plurality of adjacent side surfaces of the winding part are provided with a continuous and uninterrupted guide groove 7, the head connector 5 is provided with a jack 9 for leading out a lead, the led-out electrode lead enters from one end of the guide groove 7 and goes out through the other end of the guide groove 7, and the outgoing electrode lead is connected with an electrode;

the inner surface of the guide groove 7 is provided with a plurality of limiting structures 11, under the action of the limiting structures 11, partial areas of the electrode lead are limited in the guide groove 7, and the other parts of the electrode lead can protrude outwards from the guide groove 7 and present an arc shape; the purpose of setting up like this, its advantage lies in, can embody to have more excellent accomodating nature to long distance electrode wire, and the subregion of electrode wire can be restricted by limit structure 11, makes electrode wire unable whole region or most area withdraw from guiding groove 7, to the problem that winding and dislocation appear in the electrode wire among the prior art, will obtain solving completely.

As shown in fig. 5, the limiting structure 11 may be a protrusion 8 extending from the guiding groove 7, and by adopting the above scheme, the side surface of the winding part can be ensured to be a flat surface, so as to avoid scratching the normal use of the pocket 4 due to an irregular shape.

It should be noted that the size of the insertion hole 9 is slightly larger than the diameter of the electrode wire, which is convenient for the electrode wire to swing in the direction, and the obstacle received during the swing is smaller.

As shown in fig. 3-4, it should be further noted that the guiding groove 7 is a symmetrical groove structure, and the symmetry plane thereof coincides with the central axis of the insertion hole 9.

The symmetry plane is parallel to the rotation axis of the head connector 5 and the electrode lead jack 9 and is superposed, and the size of the placing groove is slightly larger than the outer diameter of the electrode lead

Further, there is a gap between two opposite tabs 8, in order to increase the friction between the electrode lead and the tabs 8, and secondly, to hinder the electrode lead from being pulled, for example, the electrode lead is divided into a first part inside the guide groove 7 and a second part outside the guide groove 7, the first part is recessed into the guide groove 7, and when the second part is pulled by an external force in an outward tilting direction, the first part will sink into the limiting structure 11 close to the second part, in particular into the gap between the tabs 8 facing away from the second part, and snap into the gap.

The limiting structures 11 are distributed in the guide groove 7 in an array mode, and the electrode leads in the arc shape can be regularly distributed under the design, so that the overlarge arc surface of one arc-shaped electrode lead is avoided.

In this embodiment, the protrusion 8 extends outward to form a curved surface, so as to prevent the electrode lead from being punctured by a corner, and to allow the electrode lead to be more easily trapped in the gap.

The electrode stimulation end 1 is provided with a fixing member 10 fixed on the skin surface, and the fixing member 10 can be a patch with an adhesive surface.

In the present embodiment, the housing 6 and the guide groove 7 are made of titanium alloy material; the outer surface of the head connector 5 is made of resin, polyurethane or silica gel material; the feed-through assembly 3 is made of materials such as titanium alloy, platinum iridium alloy wires, ceramics, gold and the like.

The using method of the invention is as follows:

1. (as shown in fig. 6) the electrode lead is implanted into the targeted nerve site by subcutaneous puncture and the electrode stimulation tip 1 is fixed.

2. (fig. 7) a skin incision is made below the puncture site to create a subcutaneous pocket 4.

3. (as shown in fig. 8) the electrode leads are connected to a temporary pacemaker 13, stimulation parameters are output, a determination is made as to whether the implantation was successful, and appropriate stimulation parameters are determined.

4. (as shown in fig. 9) the temporary pacemaker 13 is replaced and the electrode lead is connected to the implanted pulse generator 2.

5. (as shown in fig. 10) the redundant portion of the electrode lead is received by the guide groove 7.

6. (see fig. 11) the pulse generator 2 is implanted in the subcutaneous pocket 4.

The above embodiments are merely illustrative of the preferred embodiments of the present invention, and not restrictive, and various changes and modifications to the technical solutions of the present invention may be made by those skilled in the art without departing from the spirit of the present invention, and the technical solutions of the present invention are intended to fall within the scope of the present invention defined by the appended claims.

Claims (7)

1. An implantable neurostimulation device, comprising:

a winding part, wherein an electrode stimulation end is arranged at the tail end of a lead of the winding part, and the electrode stimulation end is conducted by a feed-through assembly in the winding part;

the peripheral surface of the winding part is provided with a plurality of guide grooves, the inner surfaces of the guide grooves are provided with limiting structures, the wires in the guide grooves can be limited in partial areas in the guide grooves under the action of the limiting structures, and the rest parts can protrude outwards from the inner parts of the guide grooves to present an arc shape.

2. The implantable neurostimulation device of claim 1, wherein: the limiting structure is a protruding part which oppositely extends from the inner side of the guide groove.

3. The implantable neurostimulation device of claim 2, wherein: the projections have a gap therebetween.

4. The implantable neurostimulation device of claim 2, wherein: the limiting structures are distributed in the guide grooves in an array mode, so that the arc-shaped electrode leads are regularly distributed.

5. An implantable neurostimulation device according to any of claims 2 to 4, wherein: the extension of the convex part is a cambered surface.

6. An implantable neurostimulation device according to any one of claims 1-4, characterized in that: the electrode stimulation end is provided with a fixing piece fixed on the surface of the skin.

7. An implantable neurostimulation device according to any one of claims 1 to 4, wherein: the guide groove is of a symmetrical structure.

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