JP2002253685A - Adhesive pad for mounting extracorporeal head of implanting type medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To facilitate the loading or unloading of a communication probe and a charging head while accurately holding them in the skin-oriented communication and the skin-oriented charging as made to an implanting type biomedical stimulator on the surface of a human body. SOLUTION: After an electromagnetic coupling to a coil on the incorporeal side being covered with the adhesive pad is set to the highest position, an adhesive protective tape of the adhesive pad is peeled off to be put tight on skin. The adhesive pad is given a shape of a bag to match the size of a head part 104. The head part is inserted from an inlet 102 provided on the side opposite to an adhesive part of the adhesive pad or on the perimeter of the adhesive part, so that even slight force will not cause the head to slip off. When a need arises for taking a head temporarily off the surface of the human body, the communication probe or the charging head alone can be removed easily from an inlet of a housing part of the adhesive pad without peeling the adhesive pad. In the recharging, the head part can be arranged at the optimum coil position simply inserting it into the housing part.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an adhesive pad for fixing a communication probe and a charging head used for performing percutaneous communication and percutaneous charging to an implantable biological stimulator on a body surface.

[0002]

2. Description of the Related Art Implantable cardiac pacemakers (hereinafter referred to as pacemakers) and implantable cardioverter defibrillators (hereinafter referred to as ICDs) have recently been used as treatment devices for heart diseases exhibiting arrhythmias such as bradycardia and tachycardia. Such implantable medical devices are widely used. Conventionally, in these medical devices, electric energy is provided by a primary battery. Therefore, when the electric energy of a built-in battery is exhausted, the device needs to be replaced. For example, in a pacemaker, its battery life is said to be about 4 to 8 years, and in an ICD, it is often replaced in about 2 years.

[0003] Patients implanted with these implantable medical devices are forced to replace the device each time the battery is exhausted, which not only increases the financial burden, but also gives the patient anxiety about implantable surgery, and , Resulting in the risk of infections associated with surgery.

As a means for fundamentally solving such a problem, a pacemaker equipped with a rechargeable battery has been proposed (JP-A-5-317433, "Pacemaker", JP-A-6-79005, "Pacemaker", JP-A-7-246.
243, "Transdermal charging device for living body implanted devices", all manufactured by Cardiopacing Research Laboratory Co., Ltd.). According to this proposal, the battery life of the pacemaker can be extended at least twice or more by charging once every few months. In these rechargeable pacemakers, an induced electromotive force is generated in a coil inside the pacemaker by a magnetic flux generated from a coil outside the body through the skin, and the induced current becomes a predetermined current value after rectification and smoothing. To charge the rechargeable battery. The minimum charging time is determined by the battery characteristics of the rechargeable battery, and about 1 to 4 hours are required for a lithium ion battery from a completely discharged state to a fully charged state. Therefore, in a rechargeable pacemaker, it is essential to stably install the coil outside the body on the body surface for a long time. In order to achieve this, a method proposed by Cardiopacing Research Laboratory Co., Ltd. is used to charge the battery by attaching a charging head with a built-in 36 mm diameter pot core type primary coil to the skin surface with adhesive tape. . In that case, after confirming the pacemaker implantation site, perform positioning marking on the skin, and then fix the charging head on the body surface using a fixing device such as adhesive tape prepared in advance. Proposed.

[0005]

However, in this method, not only the fixing operation is complicated, but also a check of the pacemaker which is indispensable at the time of a regular checkup by X-ray photography or a programmer during a long period of charge. In such a case, the charging head must be removed each time, and it is necessary to remove and fix the charging head a plurality of times. Although it is conceivable to perform X-ray imaging and a pacemaker check by a programmer before and after the charging operation, the patient is required to stay in the facility for a longer time, and the medical facility side requires a longer patient treatment time.

SUMMARY OF THE INVENTION The present invention has been made in view of the above-mentioned prior art, and it is easy to remove and re-attach a head such as a charging head or a communication head without putting a burden on a patient. It is compatible with later mounting certainty,
Adhesive pad for implantable medical device extracorporeal head that enables reliable communication with the implantable medical device via the mounted head or enables efficient charging of the implantable medical device The purpose is to provide.

[0007]

SUMMARY OF THE INVENTION The present invention has been made in order to solve such a problem, and an external coil which can mutually generate an electromotive force with a coil provided in an implantable biostimulator is provided. An adhesive pad to be attached to the body surface, wherein an adhesive material having an adhesive strength enough to hold at least the weight of the extracorporeal coil on the skin is provided on the entire surface or a part of the pad body that comes into contact with the skin. It is characterized by comprising an adhesive portion and a storage portion for storing the extracorporeal coil, the opening portion being provided on the surface of the pad body opposite to the adhesive portion or around the adhesive portion.

More preferably, the storage section has a holding mechanism so that at least the external coil does not come off under its own weight when the external coil is stored.

[0009] More preferably, the pad body is made of a flexible resin or fibrous film material.

[0010] More preferably, the adhesive portion has an adhesive effect when the adhesive pad is pressed against the skin surface with a predetermined pressure or more.

More preferably, the pad body has a shape in which the center of the contact surface is depressed from the periphery.

More preferably, the pad body is in contact with a body surface on the implantable biostimulator,
The central part of the contact surface has a concave shape depressed from the peripheral part.

With the above configuration, when it is desired to temporarily remove the head portion from the body surface, the head portion can be taken out from the opening without peeling the adhesive pad from the body surface.
The head portion can be inserted into the storage portion again from the opening.

By providing a mechanism for holding the head portion in the storage portion when the head portion is inserted, it is possible to prevent the head portion from falling off the charging pad and falling on the floor and being damaged even when the patient moves his / her body.

Further, by forming the pad body from a flexible resin or a fibrous film-like material,
An adhesive pad that is soft, easily conforms to the curved skin surface, has less discomfort, and does not inadvertently peel off the adhesive portion can be realized.

[0016] Further, by making the adhesive portion generate an adhesive action when pressed against the skin surface with a predetermined pressure or more, the head portion can be easily positioned after being positioned at the most suitable portion on the body surface. An adhesive pad can be fixed on the skin at the site.

Further, the adhesive pad is formed such that the center side of the surface in contact with the skin is recessed from the peripheral side,
It is possible to realize an adhesive pad that can be worn so as to conform to the ups and downs on the body surface due to the implanted biostimulation device.

[0018]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Specific embodiments of the present invention will be described in detail below.

[First Embodiment] FIG. 1 shows a first embodiment according to the present invention.
1 shows an adhesive pad according to an embodiment. FIG. 1A is a view of the adhesive pad 100 as viewed from the upper surface, that is, the side opposite to the surface in contact with the body surface. The adhesive pad has a circular shape as a whole, and has a head storage section 101 at the center. An opening 102 is provided in a part of the side surface of the storage unit 101. Around the edge of the opening, a force for shrinking the opening is given by an elastic material 103 such as rubber. A state in which the head unit 104 is stored in the storage unit is indicated by a broken line. In the present embodiment, a transdermal charging probe head is assumed as the head unit.
A cable 105 extending from the opening to the main body of the charger extends outside. The head accommodated in this way does not fall out of the accommodation part by its own weight due to the function of the elastic material 103. FIG. 1B is a view of the adhesive pad 100 viewed from the lower surface, that is, the surface in contact with the body surface. The adhesive 106 is coated on a part of the pad from the edge.

The head unit has a built-in coil whose axial direction is substantially perpendicular to the body surface when the head unit is mounted. The coil of the head unit is mounted on a pacemaker in the body when the head unit is mounted. And a coil whose axial direction almost coincides. When charging the pacemaker with this coil, the coil of the head part outside the body is used as the primary coil, the coil of the pacemaker is used as the secondary coil, and the coil inside the pacemaker generates an induced electromotive force to the built-in rechargeable battery. Charge. In the case of communication, communication is realized by transmitting signal power to a receiving side by using a transmitting side coil as a primary coil and a receiving side as a secondary coil.

FIG. 2 shows a cross section in a state where the adhesive pad is stuck to the pacemaker implantation site. The skin surface on which the pacemaker 201 is implanted has some swelling as shown in the figure. Therefore, it is desirable that the adhesive pad 200 has a concave shape at the center. By doing so, the pressure-sensitive adhesive coating section 202 can easily stick to the skin.

With the above configuration, when the adhesive pad according to the present invention is optimally positioned, the charging head 204 stored in the storage portion 203 of the adhesive pad has a concave shape, so that the adhesive pad is coated. The site is firmly adhered to the skin, and it can be prevented from falling off or displacing during use.

Since the adhesive pad has a concave shape, the extracorporeal head 204 having the coil 204a faces the coil 205 inside the pacemaker and comes into close contact with the epidermis at the position where the pacemaker is implanted. As a result, the charging energy is transferred, thereby shortening the charging time and saving power consumption. In communication, the transmission efficiency of signal power is increased, so that sensitivity is improved and noise resistance is increased. In addition, since the communication signal itself can be reduced in power, the power capacity of the internal battery of the pacemaker can be effectively used.

Further, the charging head can be easily detached during X-ray photography or communication with a biological stimulator by a programmer.

[Second Embodiment] FIG. 3 shows a surface of a pressure-sensitive adhesive pad according to a second embodiment which is in contact with the body surface. In this embodiment, a number of protrusions 302 are formed so as to surround the adhesive portion 301. The function of the protruding portion 302 is to prevent the adhesive from coming into contact with the skin surface at the stage of positioning the charging head, as shown in the cross section of FIG. At the time of positioning, the operator grips the storage section 401 to position the charging head. Since the pressure-sensitive adhesive pad is made of a flexible resin or fibrous film-like material, even if the housing section 401 is pressed against the body surface, a large force is not transmitted to the peripheral pressure-sensitive adhesive coated area 402. Therefore, the charging head can be moved right and left together with the adhesive pad without sticking to the body surface. When the positioning is completed, when the pressure-sensitive adhesive coated portion is pressed against the body surface, the protrusion contracts, the pressure-sensitive adhesive coated region comes into contact with the skin, and the pressure-sensitive adhesive pad is fixed.

The structure of the projection will be described in more detail. FIG. 5 shows an example of the protrusion contraction mechanism. FIG. 5A shows the protrusion 501.
Is formed by molding a relatively hard thin resin sheet. As shown in the upper part of FIG.
1 does not deform, the adhesive surface 502 is away from the skin,
When pressed from above, the projections are turned upward as shown in the lower part of FIG. 5A, and the adhesive surface 502 comes into contact with the skin.

FIG. 5B shows an example in which the protrusion is formed of a flexible material and an air chamber 503 is provided above the protrusion. An exhaust valve 504 is provided above the air chamber. As shown in the upper part of FIG. 5B, the exhaust valve 504 is initially in a closed state, and the protrusion 506 does not contract with a slight pressure. When the positioning is completed and fixed, as shown in the lower part of FIG.
By pressing the pad while pressing the upper part of 4, the air in the air chamber flows out and contracts the protrusion 506.

Instead of providing the protrusions on the adhesive surface, a structure in which the adhesive surface is provided on the indented portion may be used. FIG. 5 (c)
Is an example of a structure in which an adhesive portion 509 is recessed instead of providing a protrusion. As shown in the upper part of FIG. 5C, by the action of the rib 508 formed on the back sheet 507 on which the adhesive portion 509 is formed, the adhesive portion 509 does not protrude with a slight force, and the surface sheet 510 is not applied to the skin surface. Only in contact. When the back sheet 507 is pressed from above as shown in the lower part of FIG.
08 is crushed and the adhesive portion 509 protrudes from the hole of the topsheet 510 and adheres to the skin.

As described above, by adopting a structure in which the adhesive surface does not come into contact with the body surface unless a certain force is applied, the head position can be easily changed at the time of positioning. The adhesive pad can be securely fixed to the skin.

Further, in addition to the above, the effect provided by the adhesive pad of the first embodiment can be similarly obtained.

[Third Embodiment] As a third embodiment, an adhesive pad employing the structure of FIG. 6 will be described.

This adhesive pad has a substantially circular shape, and is provided with a plurality of radially wedge-shaped cuts, eight in FIG. Since this cut is for forming a concave shape for making close contact with the buried portion of the pacemaker, it is sufficient that the cut has such a shape as to be in a mounted state. Since the pad body has flexibility, the cut may be about four places. Further, on the mounting surface of the pad, an adhesive portion 602 applied with an adhesive is provided in a peripheral portion. Also, as in FIG. 1, a storage section 603 for storing the head is provided on the surface opposite to the adhesive surface.

By adopting such a shape, the step of three-dimensional molding is not required, and the adhesive pad body can be manufactured only by cutting the material on the plane. Therefore, in addition to the effects of the first embodiment, Manufacturing costs can be reduced.

[0034]

As described above, according to the present invention,
The head, which is in close contact with the body surface for communication or charging to implantable medical devices such as implantable cardiac pacemakers and implantable cardioverter defibrillators, can be held in the expected position even when worn for a long time. .

Further, the charging head can be easily removed, and when the head portion is to be mounted on the body surface again, the charging head can be easily arranged at the original head position.

Further, at the time of positioning for mounting, the mounting position can be easily moved.

Further, by improving the adhesion of the head to the implantable medical device and maintaining the head at the intended position, communication and charging between the extracorporeal head and the implantable medical device can be performed with high efficiency. Can be.

[Brief description of the drawings]

FIG. 1 is an external view of a first embodiment of an adhesive pad according to the present invention.

FIG. 2 is a sectional view of the first embodiment.

FIG. 3 is an external view of a second embodiment of the adhesive pad according to the present invention.

FIG. 4 is a cross-sectional view of the second embodiment.

FIG. 5 is a diagram illustrating a structure of a protrusion according to a second embodiment.

FIG. 6 is a diagram illustrating a structure of a protrusion according to a third embodiment.

Claims (6)

[Claims] 1. An adhesive pad for attaching an extracorporeal coil capable of generating an electromotive force mutually with a coil provided in an implantable biostimulation device to a body surface, the entire surface of the pad body being in contact with the skin. Alternatively, an adhesive portion having an adhesive material having an adhesive strength enough to hold at least the weight of the extracorporeal coil on the skin, and a surface of the pad body opposite to the adhesive portion or around the adhesive portion. And an accommodating portion for accommodating the extracorporeal coil, the adhesive pad for attaching an extracorporeal head of an implantable medical device. 2. The implantable medical device according to claim 1, wherein the storage section has a holding mechanism so that at least the external coil does not come off under its own weight when the external coil is stored. An adhesive pad for mounting the extracorporeal head of the device. 3. The adhesive pad for mounting an extracorporeal head on an implantable medical device according to claim 1, wherein the pad body is made of a flexible resin or fibrous film material. 4. The extracorporeal head mounted on an implantable medical device according to claim 1, wherein the adhesive section produces an adhesive action when the adhesive pad is pressed against the skin surface with a predetermined pressure or more. Adhesive pad. 5. The implantable medical device according to claim 1, wherein the pad body has a shape in which a center portion of a contacting surface is depressed from a peripheral portion. Adhesive pad for head mounting. 6. The pad body has a concave shape in which a center portion of the contact surface is depressed from a peripheral portion when the pad body is in contact with a body surface on the implantable biostimulation device. Item 5. An adhesive pad for mounting an extracorporeal head of an implantable medical device according to any one of Items 1 to 4.