KR20190062077A - Implantable medical device - Google Patents

Abstract

The present invention relates to an implantable medical device, including a power receiving part for receiving power by a wireless power transmission method using an ultrasonic signal in a power transmitter outside the human body; a battery for charging power received through the power receiving part; a case formed in a tubular shape having an opened upper surface and forming an outer shape; and a vibration shielding layer which attenuates the vibration due to the ultrasonic signal and shields the transmission thereof outside the case. Thus, the present invention can provide a shielding layer having vibration shielding particles or a structure on the lower and the outer sides of the case so as to attenuate the ultrasonic vibration and shield the vibrations from being transmitted to the tissues or skeletons of the human body through the case.

Description

[0001] IMPLANTABLE MEDICAL DEVICE [0002]

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to an implantable medical device, and more particularly, to an implantable medical device for wirelessly transmitting power to an in-vivo medical device.

Recently, in order to alleviate or treat various symptoms of diseases, artificial organs such as pacemakers, cochlear implants, spinal cord stimulators, cardiac defibrillators, cardiac pacemakers, insulin pumps, foot drop implants, And deep brain stimulation (DBS) are being developed.

Among them, the deep brain stimulation device is an implantable medical device that alleviates the symptoms of brain diseases such as Parkinson's disease by applying electrical stimulation to specific parts of the brain.

The deep brain stimulation apparatus according to the related art comprises an electrode implanted in the brain, a control device which is implanted in the chest area to generate an electric stimulation signal, and a connection line connecting the electrode and the control device.

Among the above configurations, the control device is composed of a complicated electronic circuit based on a microprocessor, a battery for driving for about five years, and an RF transceiver for communicating with the outside, and in particular, for stable operation for a long period in vivo The basic structure of a cardiac pacemaker which is housed in a titanium case and sealed by laser welding is used as it is.

Therefore, in the deep brain stimulation apparatus according to the prior art, the manufacturing cost of the control apparatus becomes high and the size becomes large, so that the implantation site must be lowered to the chest. Especially, if the life of the battery is shortened within 5 years, .

In order to solve such a problem, Patent Document 1 and Patent Document 2 described below disclose a deep brain stimulation apparatus technique employing wireless power transmission technology.

Patent Document 1 discloses a technique in which a rotating magnetic field is formed by a rotating magnetic field disc provided inside a cap worn by a patient and induction power is generated by an induction coil plate fixed to the lower part of the patient's scalp to be combined with the formed rotating magnetic field, Which is capable of calibrating abnormal exercise and sensory functions by using electric power supplied from outside of the human body through radio waves.

Patent Document 2 includes an in-body device implanted in the scalp and an extracorporeal device that supplies power to the in-vivo device by a wireless power transmission system. The wireless power transmission part of the extracorporeal device includes an external Wherein the wireless power receiving portion of the in-body device includes an inner coil arranged to the outer coil so that an AC power is formed by a magnetic field induced in the outer coil, an inner magnet wound around the inner coil And the outer magnet is attached to the inner magnet so that the outer coil and the inner coil are aligned with each other to connect the extracorporeal device to the in-body device. By combining the wireless power transfer function, a semi-permanent deep brain The stimulation system configuration is described.

Korean Patent Registration No. 10-0877228 (issued on December 26, 2008) Korean Patent Registration No. 10-1662594 (issued on October 6, 2016)

The deep brain stimulation apparatus to which the conventional technology including the patent documents 1 and 2 applies the wireless power transmission technology generates inductive power in a magnetic induction manner between the rotating magnetic field disc and the induction coil plate provided in the in- And transmits electric power to an in-vivo device.

However, in the deep brain stimulation apparatus using the wireless power transmission technology according to the related art, when power is transmitted to the in-body apparatus using the wireless power transmission scheme, the power transmitted from the in-vivo apparatus is used to stimulate the deep brain, There was no way to control the power you wanted to receive.

Accordingly, the deep brain stimulation apparatus to which the wireless power transmission technology according to the related art is applied, continuously transmits the transmission in the extracorporeal device irrespective of the load variation in the in-vivo apparatus, the power of the battery provided in the extracorporeal device is consumed , The efficiency is lowered.

Meanwhile, a method of transmitting energy by radio includes a method of transmitting electric power using electromagnetic induction, a method of transmitting electric power using radio frequency (Radio Frequency), and a method of transmitting electric power using ultrasonic wave .

The power transmission apparatus using electromagnetic induction is composed of a charging matrix for generating charging power using an external power source and a power receiving module for receiving charging power through electromagnetic induction from a charging matrix. Is the closest technology to.

However, since the electromagnetic energy is sharply reduced in the air by a distance inversely proportional to the square of the distance, the electric power transmission device using electromagnetic induction is limited to the use of the charging matrix and the power receiving module at a distance of several centimeters .

A power transmission device using radio frequency collects energy of RF having a very long propagation distance and supplies electric power to an electronic device or a sensor. There are many RFs in the air, and their propagation distance is very wide. However, RF has a problem of low energy density and low energy amount after energy conversion.

The power transmission apparatus using ultrasonic waves is composed of a transmitting apparatus for generating ultrasonic waves and a receiving apparatus for receiving the generated ultrasonic waves. Ultrasonic waves are transmitted through a vibrating medium by vibrating the medium by vibrations generated from the ultrasonic device by interaction with the medium.

A power transmission apparatus using ultrasonic waves can be used in various media such as water or human skin. However, there is a problem in that power transmission efficiency between ultrasonic transmission and reception apparatuses is deteriorated when transmitting apparatuses and receiving apparatuses such as water or human skin are separated from each other .

In particular, when power is transmitted wirelessly to a medical device implanted in the body using ultrasonic waves, ultrasonic signals can cause damage to the tissues or skeleton of the human body, causing vibrations throughout the medical device.

Therefore, there is a demand for development of a technique capable of shielding the vibration applied to the human body so as to minimize the damage of the body breakfast by the ultrasonic vibration and to stably attach the tissue to the tissue.

SUMMARY OF THE INVENTION An object of the present invention is to provide an implantable medical device capable of wirelessly transmitting power to an in-vivo device implanted in the body using ultrasound in vitro.

It is another object of the present invention to provide an implantable medical device capable of shielding ultrasonic vibrations in a process of receiving power wirelessly transmitted using ultrasonic signals to prevent transmission of vibration into the body.

In order to achieve the above object, a medical implantable medical device according to the present invention includes: a power receiver for receiving power in a non-electric power transmission system using an ultrasonic signal in a non-electric power transmission mode; A case for forming an external shape, and a vibration shielding layer for shielding transmission of the ultrasonic signal to the outside by attenuating vibrations caused by the ultrasonic signal.

As described above, according to the implantable medical device according to the present invention, the vibration shielding layer having vibration shielding particles or structure is provided on the lower and the outer sides of the case to attenuate the ultrasonic vibration, An effect is obtained that the vibration can not be transmitted.

Thus, according to the present invention, it is possible to prevent damage to tissues or skeleton of a human body due to vibration during a wireless power transmission process using ultrasonic waves, and to prevent discomfort or pain of a user by ultrasonic vibration.

1 is a block diagram of a deep brain stimulation apparatus according to a preferred embodiment of the present invention.
FIG. 2 is an exploded view of the deep brain stimulation apparatus shown in FIG. 1,
FIG. 3 is a schematic cross-sectional view of the deep brain stimulation apparatus shown in FIG. 2,
4 is a schematic cross-sectional view of a deep brain stimulation apparatus according to another embodiment of the present invention,
5 is a schematic cross-sectional view of a deep brain stimulation device according to another embodiment of the present invention.

Hereinafter, an implantable medical device according to a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

In this embodiment, a deep brain stimulation device is described as a neurotransmitter supplying device for implantable medical devices, but the present invention is not limited thereto.

That is, the present invention relates to an artificial organs such as a pacemaker, an artificial worm, a gastric stimulator, a spinal cord stimulator, a heart stimulator, or the like, which are used for implanting an internal apparatus and stimulating nerves and supplying neurotransmitters, It should be noted that the present invention may be applied to various implantable medical devices such as defibrillators, cardiac pacemakers, insulin pumps, and foot drop implants.

FIG. 1 is a block diagram of a deep brain stimulation apparatus according to a preferred embodiment of the present invention, and FIG. 2 is an exploded view of the deep brain stimulation apparatus shown in FIG.

As shown in FIG. 1, the deep brain stimulation apparatus 10 according to the preferred embodiment of the present invention is a device that implants in the scalp and supplies electric power supplied from an external power transmitter 12 in a wireless power transmission system using ultrasonic waves Use it to stimulate the cranial nerves.

The deep brain stimulation apparatus 10 senses a variation in power load due to various factors such as thickness of skin, degree of hair growth, changes in blood flow, and transmits sensed load information to the management terminal 11 Can be transmitted.

To this end, the deep brain stimulation apparatus 10 includes a power receiving section 20 for receiving the power transmitted from the power transmitter 12, a battery 30 for charging the power received via the power receiving section 20, And a stimulation unit 40 for stimulating the cranial nerve using power supplied from the stimulation unit 40.

The deep brain stimulation apparatus 10 further includes a control unit 60 for controlling the driving of each device provided in the deep brain stimulation apparatus 10 and a communication unit 60 for communicating with the management terminal 11 in a wireless communication manner .

The management terminal 11 receives the operation status information of the deep brain stimulation apparatus 10 and the information sensed by the deep brain stimulation apparatus 10 through communication with the deep brain stimulation apparatus 10, ) And to change or update the program of the deep brain stimulation apparatus 10. [0060] FIG.

The power transmitter 12 may be provided as an ultrasonic transducer for receiving electric power from a commercial power source, converting electric energy into an ultrasonic signal of a predetermined frequency, and transmitting the converted ultrasonic signal to the deep brain stimulation apparatus 10.

The power transmitter 12 may include a drive control unit 13 for converting electric energy into an ultrasonic signal to generate an ultrasonic signal and controlling the transmission of the generated ultrasonic signal.

The power transmitter 12 may include a matching layer 14 for matching with the power receiving unit 20 of the deep brain stimulation apparatus 10 described below.

The power receiving unit 20 may be provided as an ultrasonic transducer that converts the ultrasonic signal transmitted from the power transmitter 12 into electric energy and receives electric power.

To this end, the power receiving unit 20 may include a piezoelectric element that changes the voltage of the electric energy by the pressure generated by the ultrasonic signal.

2, the power receiving unit 20, the control unit 50, the communication unit 60 and the battery 30 are sequentially stacked in the case 80 along the vertical direction, and the power receiving unit 20 The upper surface of the case 80 may be packaged and a matching layer 70 may be provided to match the acoustic impedance with the power transmitter 12.

A vibration shielding layer 90 may be provided under the case 80 to shield the vibration transmitted from the power receiving unit 20 from being transmitted to the inside of the body.

That is, the ultrasonic signal transmitted from the power transmitter 12 is transmitted to the power receiver 20 through the skin layer of the human body or the medium layer such as blood.

The transmission efficiency of power transmitted wirelessly between the power transmitter 12 and the power receiver 20 depends on the characteristics of the medium layer, namely, the material, geometry, transmission medium, attenuation attenuation) and the distance between the power transmitter 12 and the power receiver 20.

Therefore, the present invention can improve the wireless power transmission efficiency by using the materials and the geometrical structure of the matching layers 14 and 70 provided in the power transmitter 12 and the power receiver 20, respectively.

On the other hand, the vibration shielding layer 90 is configured to attenuate the vibration due to the ultrasonic signal transmitted to the power receiver 20 and to prevent the vibration from being transmitted to the outside of the case 80, And to prevent the user's discomfort or pain due to pressure.

The structure of the vibration shielding layer 90 will be described in detail below with reference to FIG. 3 to FIG.

1 and 2, the battery 30 may be provided with a rechargeable secondary battery.

The stimulating unit 40 includes an internal microcontroller (not shown) for generating a specific stimulating waveform for stimulating the cranial nerve using the DC power supplied from the battery 30, a stimulation circuit (not shown) And an electrode for stimulation that stimulates the brain according to the generated stimulation waveform.

The controller 50 may be provided as a main controller that controls driving of each device provided in the deep brain stimulation apparatus 10. [

The control unit 50 may control the driving of the stimulation unit 40 to adjust the stimulation applied to the deep brain according to the driving program stored in the memory (not shown).

In addition, the control unit 50 transmits the load information to the management terminal in the course of stimulating the cranial nerves through the communication unit 60, which detects variations in the power load due to various factors such as the thickness of the skin, the degree of hair growth, Can be controlled.

To this end, the deep brain stimulation apparatus 10 further includes sensing means (not shown) for sensing the load information, and the sensing signal output from the sensing means may be transmitted to the controller 50 .

The sensing means may further include a plurality of sensing sensors for sensing various information such as body temperature, blood pressure, respiration amount, and temperature of the battery 30 in addition to the load information.

The control unit 50 can control to change or update the program for driving the stimulating unit 40 according to the control signal received from the management terminal 11 through the communication unit 60. [

2, each of the devices 20, 30, 50, 60, and 70 accommodated in the case 80 and the case 80 is shown in a cylindrical shape and a disc shape, but the present invention is not limited thereto The case 80 may be formed in a polygonal tubular shape such as a rectangular tube and the devices 20, 30, 50, 60, and 70 accommodated in the case 80 may be formed into a polygonal shape.

Next, the configuration of the vibration shielding layer will be described in detail with reference to FIGS. 3 to 5. FIG.

3 is a schematic cross-sectional view of the deep brain stimulation apparatus shown in FIG.

First, before describing the configuration of the vibration shielding layer 90, the configuration of the matching layer 70 will be briefly described.

The matching layer 70 is made of a biocompatible material having acoustic impedance similar to skin and blood of the human body forming the medium layer and satisfying human safety standards as it is implanted in the body .

The biocompatibility defines a bidirectional response, i.e., the response of the body to a substance and the response of the materials to the body environment.

In particular, the biocompatibility of a medical device represents the ability of the device to perform the intended function with the desired degree of binding within the host, without introducing undesired local or systemic effects at the host.

In this embodiment, the biocompatible material is a medical grade or implant grade material.

Therefore, in this embodiment, the case 80 forming the outer shape of the deep brain stimulation apparatus 10 and the matching layer 70 packaging the upper surface of the case 80 are manufactured using a material of biocompatible material.

For example, the case 80 may be made of a biocompatible metal material, such as titanium.

On the other hand, the acoustical impedance of the skin is about 1.5Mrayl, and the acoustic impedance of the blood, i.e., water, is about 1.48Mrayl.

The acoustic impedance (Z) is the ratio between the velocity of the medium and the sound pressure, and is the amount of sound pressure (P) acting on the plane parallel to the wavefront on which the sound waves are transmitted divided by the volume velocity (uS) (Z = P / uS).

For example, the matching layer 70 may be formed of a material of a silicon-based material, such as silicon rubber, having an acoustic impedance similar to skin or blood of the human body, i.e., an acoustic impedance of about 1.4 to 1.6 Mrayl, such as a polymer such as epoxy or polyurethane.

Alternatively, the matching layer 70 may be made of a material having an acoustic impedance higher than the acoustic impedance of skin or blood of the human body constituting the medium layer.

For example, the matching layer 70 may be formed using a polymeric compound such as polyethylene, polypropylene, or polyester having an acoustic impedance of about 1.5 to about 3 Mrayl, which is higher than the acoustic impedance of skin or blood. .

The acoustic impedance of the polyethylene is about 1.78Mrayl, the acoustic impedance of the polypropylene is about 2.24Mrayl, and the acoustic impedance of the polyester is about 2.86Mrayl.

The matching layer 70 may have a plurality of conical or hemispherical protrusion structures so as to continuously change the acoustic impedance of the medium layer.

That is, in the matching layer 70, air having an acoustic impedance of about 0.000409Mayl is filled in the upper end of each projection, and as the cross-sectional area of each projection 71 increases toward the lower end of each projection, the acoustic impedance gradually increases The overall acoustic impedance of the matching layer 70 can be approximated by the impedance of the skin and blood of the human body.

Therefore, the protrusion structure provided in the matching layer 70 can prevent the reflection of the ultrasonic signal, and can transmit the ultrasonic signal to each piezoelectric element of the power receiving unit 20.

3, the vibration shielding layer 90 is provided under the inner space of the case 80 and includes a power receiving unit 20, a battery 30, a control unit 50, and a communication unit 600 And shields the vibration transmitted through the case 80 from being transmitted to the outside of the case 80.

For this purpose, the vibration-shielding layer 90 may be formed using a biocompatible silicon-based material, a polymer such as an epoxy or a polyurethane, or the like, in the same manner as the matching layer 70 .

The vibration shielding layer 90 is provided under the battery 30 disposed at the lower end of the inner space of the case 80. The side wall of the vibration shielding layer 90 is provided in the case 80 along the inner surface of the case 80, As shown in FIG.

In addition, the vibration shielding layer 90 may include vibration shielding particles 91 for attenuating vibration or a vibration shielding structure.

The vibration shielding particles 91 may be made of a synthetic resin material having biocompatibility and impact resistance such as polyetheretherketone.

The diameter of the vibration shielding particles 91 may be changed according to the driving frequency of the ultrasonic signal and the wavelength of the vibration.

That is, the relationship between the wavelength, the frequency, and the sound velocity of the medium is defined by Equation 1 below.

For example, when the acoustic velocity of ultrasonic waves in silicon is about 1485 m / s and the driving frequency of the ultrasonic signal used in the transmission of ultrasonic waves using ultrasonic waves is about 300 kHz, the diameter of the vibration shield particles is the size of the medium Wavelength / 2, i.e., about 2.4 mm.

That is, in this embodiment, by applying the vibration shielding particles 91 having a diameter larger than 1/2 of the wavelength calculated by using the frequency of the ultrasonic signal and the sound velocity of the medium to the vibration shielding layer 90, Can be attenuated.

The vibration shielding structure may be a linear, lattice, embossed, irregular array structure or the like.

That is, the vibration shielding structure may have a lattice structure having a hole with a size smaller than 1/2 of the wavelength calculated using the frequency of the ultrasonic signal and the sound velocity of the medium, a linear structure in which a plurality of lines are arranged side by side, An embossed structure in which particles are formed along a line, or a structure in which lines or irregularly arranged particles are arranged.

As described above, according to the present invention, the vibration shielding layer having the vibration shielding particles or the structure is provided in the lower part of the case to attenuate the ultrasonic vibration, so that the vibration can not be transmitted through the case to the tissue or the skeleton of the human body.

Accordingly, it is possible to prevent damage to tissues or skeleton of a human body due to vibration during wireless power transmission using ultrasonic waves, and to prevent discomfort or pain of a user by ultrasonic vibration.

Meanwhile, although the vibration shielding layer is provided under the inner space of the case in the present embodiment, the present invention is not limited thereto.

For example, FIG. 4 is a schematic cross-sectional view of a deep brain stimulation apparatus according to another embodiment of the present invention, and FIG. 5 is a schematic cross-sectional view of a deep brain stimulation apparatus according to another embodiment of the present invention.

4, the deep brain stimulation apparatus 10 according to another embodiment of the present invention includes a vibration shielding layer 90 provided under the inner space of the case 80 and an outer surface and a bottom surface of the case 80, Shielding layer 100 that surrounds the first vibration-shielding layer 100.

Here, the lower portion of the first vibration-shielding layer 100 may be formed to have a larger diameter or area than the upper portion to increase the contact area with the human body.

5, the deep brain stimulation apparatus 10 according to another embodiment of the present invention includes a vibration shielding layer 90 provided under the inner space of the case 80 and an outer surface of the case 80, And a second vibration shielding layer 110 surrounding the upper surface of the case 80. The first vibration shielding layer 100 may be formed to surround the upper and lower surfaces.

Here, the vibration shielding layers (90, 100, 110) may be provided with at least one layer of the vibration shielding particles (91, 101) or the vibration shielding structure.

Therefore, according to the present invention, the vibration shielding layer can further improve the vibration shielding performance by forming the vibration shielding particles or the vibration shielding structure into a plurality of layers.

The vibration shielding particles 91 and 101 and the vibration shielding structure may be provided at various positions such as the top and bottom surfaces of the vibration shielding layers 90, 100 and 110, and the middle between the vibration shielding layers 90, 100 and 110.

As described above, according to the present invention, a vibration shielding layer for attenuating ultrasonic vibrations can be provided on the lower and the outer sides of the case so that vibration can be prevented from being transmitted to the outside of the case.

Accordingly, it is possible to prevent damage to the tissue or skeleton of the human body due to vibration during the wireless power transmission process using ultrasonic waves, and to prevent discomfort or pain of the user by ultrasonic vibration.

Although the invention made by the present inventors has been described concretely with reference to the above embodiments, the present invention is not limited to the above embodiments, and it goes without saying that various changes can be made without departing from the gist of the present invention.

In the above-described embodiments, the structure of the deep brain stimulation device is described as a device for supplying a neurotransmitter for a medical implantable medical device. However, the present invention is not limited to the cardiac stimulation device used for implanting an in- Such as an artificial organs such as a pacemaker, a pacemaker, a pacemaker, a spinal cord stimulator, a heart defibrillator, a cardiac pacemaker, an insulin pump, and a hip joint.

In the above embodiments, the stimulation unit and the sensing unit are provided at the same time. However, the present invention provides only a sensing unit such as a neurostimulator and a BMI (Brain Machine Interface) Or to medical devices that only detect biometric information.

The present invention provides a vibration shielding layer for attenuating ultrasonic vibration to shield vibrations from being transmitted to the outside of the case, thereby preventing damage to tissues or skeleton of a human body due to vibration during a wireless power transmission process using ultrasonic waves, The present invention is applied to the implantable medical device technology that prevents the user's discomfort or pain.

10: deep brain stimulation device
11: management terminal 12: power transmitter
13: drive control section 14: matching layer
20: Power receiving unit 30: Battery
40: stimulating unit 50:
60: communication unit 70: matching layer
80: Case 90: Vibration shielding layer
100, 110: first and second vibration shielding layers
91,101: vibration shielding particles

Claims (11)

A power receiver for receiving power in an in-vitro power transmitter using an electroless power transmission method using an ultrasonic signal,
A battery for charging the power received through the power receiver,
A case formed into a tubular shape having an opened upper surface and forming an outer shape;
And a vibration shielding layer for shielding transmission of the ultrasound signal to the outside of the case by attenuating vibration caused by the ultrasonic signal. The method according to claim 1,
Wherein the vibration shielding layer is provided in a lower portion of the case inner space,
Wherein the side wall of the vibration shielding layer extends to the upper end of the case along the inner surface of the case. 3. The method of claim 2,
And a first vibration shielding layer surrounding the outer surface and the bottom surface of the case. The method of claim 3,
And a second vibration shielding layer surrounding the upper surface of the case. 5. The method according to any one of claims 1 to 4,
Wherein the vibration shielding layer is manufactured using a material of a biocompatible material. 6. The method of claim 5,
Wherein each vibration shielding layer is made of a material of a silicon-based material or a polymer compound. 6. The method of claim 5,
Each vibration shielding layer is provided with at least one layer of a plurality of vibration shielding particles so as to enhance the vibration damping effect,
Wherein the vibration shielding particles are made of a synthetic resin material having biocompatibility and impact resistance. 8. The method of claim 7,
Wherein the diameter of the vibration shielding particle is set to be larger than 1/2 of the wavelength calculated using the frequency of the ultrasonic signal and the sound velocity of the medium. 6. The method of claim 5,
Each vibration shielding layer is provided with at least one layer of a vibration shielding structure so as to enhance the vibration damping effect,
Wherein the vibration shielding structure is formed of any one of linear, lattice, emboss, and irregular array structures using a material having biocompatibility. The method according to claim 1,
A stimulation unit for stimulating the nerve using electric power supplied from the battery,
A sensing unit for sensing a change in power load or biometric information in a process of stimulating the nerve,
A communication unit communicating with the management terminal through a wireless communication system;
Further comprising a control unit for controlling driving of each device provided in the implantable medical device,
Wherein the control unit controls the communication unit to transmit the load information and the biometric information detected by the sensing unit to the management terminal,
Wherein the stimulation unit and the sensing unit are provided at the same time or only one of them is provided. The method according to claim 1,
The power transmitter includes a drive control unit for converting electric energy into an ultrasonic signal to generate an ultrasonic signal and transmitting the generated ultrasonic signal,
And a matching layer that matches the acoustic impedance with the power receiving unit.

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