ES2630729B1 - SPECIFIC TOOL FOR USE IN REPLACEMENT INTERVENTIONS OF IMPLANTABLE ELECTRICAL STIMULATION DEVICES EQUIPPED WITH AUXILIARY PORT - Google Patents

Abstract

Specific tool for use in replacement interventions of implantable electrical stimulation devices equipped with auxiliary port, comprising a main body (101) of insulating material, configured as a handle, which has a front part (102) of a pusher shaped hollow cylinder, of the same material, whose outer width (D) is appropriate to allow its insertion in the auxiliary port (9) of the connector block (1) of the implantable device (4) and to exert thrust on the distal end of the electrode (6) ), there being a longitudinal duct (103), which crosses both the main body (101) and the front part (102) of the pusher, suitable for inserting through it a semi-rigid stylus (11) through which it is adjusted but with freedom of movement.

Description

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SPECIFIC TOOL FOR USE IN REPLACEMENT INTERVENTIONS OF IMPLANTABLE ELECTRICAL STIMULATION DEVICES EQUIPPED WITH

AUXILIARY PORT

D E S C R I P C I Ó N

OBJECT OF THE INVENTION

The invention, as stated in the present specification, refers to a specific tool for use in replacement interventions of implantable electrical stimulation devices provided with an auxiliary port, which contributes, to the aforementioned function to which it is intended, advantages and characteristics, which will be described in detail below, which are a novelty in the current state of the art.

More specifically, the object of the invention focuses on a specific tool for attaching to a stylet and safely facilitating the disconnection of the electrodes in replacement interventions of implantable electrical stimulation devices, in particular for those whose connector block incorporates an auxiliary port. , as described by the applicant himself in the Spanish patent application document P201531622.

The object of the present invention is, therefore, a specific tool that allows simultaneously executing the two main attributes of said device with "auxiliary port": to serve as a thrust path after the electrode with adhesions or a certain degree of blockage and guarantee stimulation to the patient throughout the procedure.

FIELD OF APPLICATION OF THE INVENTION

The field of application of the present invention is part of the industry sector dedicated to the manufacture of medical devices and devices, focusing particularly on the field of implantable devices for cardiac, neurological electrical stimulation ...

BACKGROUND OF THE INVENTION

How is it known, a cardiac stimulation device, pacemaker, defibrillator, is a

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Implantable prosthesis, capable of detecting the electrical-mechanical activity of the heart and, if not produced, sending enough energy through electrodes to cause cardiac contraction and thus prevent asystole.

For this, an electrical stimulation system comprises the following elements:

- A pulse generator, which contains the battery and the control and memory circuits, connector block ...

- And one or more electrodes, formed by metallic filaments and insulating systems. They are the physical support through which energy and information travel between the pulse generator and the structure to be stimulated.

Modern pulse generators have an approximate volume of 10cc and incorporate different automatisms, some for safety reasons, others to obtain the best clinical benefit of the patient's particular conditions or, simply, others for optimizing consumption and extending the useful life of device.

For its part, the connector block houses the connections and screws for fixing the electrodes and the battery. They are usually made of polyurethane or silicone. The connector block has been adapted to the technological evolution of electrodes and connections. In current systems there is a standard IS1 connection that guarantees compatibility between different manufacturers.

The fixing screws are tightened, for safety, with a torque wrench and, in addition, are protected by a valve that prevents the passage of fluids into the connection.

As noted, the electrode is the physical support that brings the cardiac tissue into contact with the pulse generator with a double function, stimulation if necessary and detection of the electrical activity linked to the contraction.

The electrodes can be unipolar or bipolar and use different alloys in their conductors; The most commonly used insulators are silicone and polyurethane.

But there is something that is common to all of them and that is that the inside of the inner conductor is a

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Lumen designed to, with the help of a metal guide or stylet, be able to direct the electrode to the desired position. The stylet is in physical and electrical contact with the inner conductor.

It should be noted, on the other hand, that the life of the pacemaker battery is about ten years. After this time, the pulse generator is replaced, keeping the electrode previously implanted.

This surgical procedure consists in opening the fibrotic bag where the device is housed and debriding the electrode body, freeing it from adhesions. Then, the fastening screws are loosened, the pacemaker to be replaced is disconnected and the new device is connected.

The intervention, conceptual and practically, is very simple, however, there are usually common problems of two types:

- Relating to electrode release. The surgeon must be careful when releasing perielectrode fibrosis to avoid damage to insulators and conductors. Even so, when loosening the fastening screws and trying to pull back in order to disconnect the electrode, difficulties are usually encountered due to blocked screws, presence of fluids inside the connector block, adhesions produced by interaction between the silicones of the cable and the internal part of the connector block and the vacuum formation in the distal part of the connector block. In these circumstances, if you drive too hard, you run the risk of eroding insulation or affecting drivers.

- Relating to the patient's clinical situation. Many of the patients who have to change the device do not have an escape rate. They are called "pacemaker-dependent." That your heart contracts depends exclusively on the stimulation provided by the pacemaker. In the absence of this, when disconnected, the patient undergoes a temporary asystole and, as a probable consequence, the appearance of "Crisis of Stokes Adams ”, ventricular arrhythmias ...

Temporary asystole during the change of the pulse generator is a risk situation that should be avoided. In the operating room, drugs that potentiate the appearance of intrinsic activity are usually used and, for more extreme cases, the heart rate is guaranteed during the intervention with the installation of an external pacemaker.

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To solve both common problems, the applicant himself is the owner of a patent application relating to a connector block for said devices which, advantageously, and characteristically incorporates an auxiliary port.

Specifically, said document describes a connector block for implantable electrical stimulation devices that is distinguished by having at least one auxiliary port provided with a valve through which we can introduce:

- A torque wrench or similar to push the distal end and achieve unlocking when necessary.

- A stylet that, being in contact with the internal electrode conductor, provides us with a way to maintain the stimulation during the procedure through the use of an analyzer and measuring cables.

Therefore, it would be desirable and it is the objective of the present invention, to have a specific tool for use in devices equipped with an auxiliary port, which simultaneously facilitates the desired objectives: assistance in mechanical electrode release and safety by being able to guarantee stimulation throughout The procedure.

On the other hand, and as a reference to the current state of the art, it should be noted that, at least by the applicant, the existence of no other tool for electrode disconnection operations in implantable electrical stimulation devices or similarly applied invention is unknown. , nor that it presents technical, structural and constitutive characteristics similar to those presented here.

EXPLANATION OF THE INVENTION

Thus, the specific tool for use in replacement interventions of implantable electrical stimulation devices equipped with an auxiliary port that the invention proposes is configured as a remarkable novelty within its field of application, since according to its implementation and in a taxable way it is They satisfactorily achieve the aforementioned objectives as suitable, the characterizing details thereof being conveniently included in the final claims that accompany the present description.

Specifically, said tool consists of a plastic body configured to

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handle mode, of dimensions similar to a torque wrench, in which a longitudinal duct that allows the passage of a semi-rigid stylet through it, as well as the sliding thereof has been drilled.

Said body, in turn, has a front part, which we will call a pusher, consisting of a thin cylinder, of the same material, also hollow to be equally crossed by the stylet, whose outer diameter is appropriate to allow its passage through the port auxiliary of the device connector block, to be able to exert thrust on the distal end of the implanted electrode.

Thus, by inserting the stylet into the tool and, later through the auxiliary port inside the implanted electrode, a way of maintaining the stimulation throughout the procedure is guaranteed.

By sliding the tool over the stylet and also through the auxiliary port, thrust is achieved to unlock the electrode without stimulation being compromised at any time.

If the patient is a pacemaker dependent, the stimulation of the heart can be achieved by connecting to the stylet and conduction inside the electrode, and the mobile tool through the stylet, proceeds to push the blocked cable with the front of the pusher, so the resolution of this contingency is carried out in the same act and with a simple maneuver and devoid of uncertainty.

The described specific tool for use in replacement interventions of implantable electrical stimulation devices equipped with an auxiliary port represents, therefore, an innovation of structural and constitutive characteristics unknown until now, reasons that together with its practical utility, provide it with sufficient basis to obtain the privilege of exclusivity that is requested.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the features of the invention, this descriptive report is attached, as an integral part thereof, of a set of drawings, in which

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For illustrative and non-limiting purposes, the following has been represented:

Figure number 1.- Shows a schematic perspective view of an example of the tool object of the invention, represented once incorporated into the stylet, showing the main parts it comprises.

Figure number 2.- Shows a perspective view of the mode of use of the tool for disconnecting electrodes in a pacemaker.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the aforementioned figures, and in accordance with the numbering adopted, an example of the specific tool for use in replacement interventions of implantable electrical stimulation devices provided with a recommended auxiliary port can be observed, which comprises the parts and elements indicated and described in detail below.

Thus, as seen in Figure 1, the tool (100) in question comprises a main body (101), of plastic or other insulating material, configured as a handle, which has a front part (102) in the form of hollow, narrow and elongated cylinder, also of the same material, which acts as a pusher, preferably consisting of a cylinder whose outer diameter or width (D) is appropriate to allow its insertion into the auxiliary port (9) of the connector block (1) ) of the implantable electrical stimulation device (4), to be able to exert thrust on the distal end of the electrode (6), there being a longitudinal conduit (103), which crosses both the main body (101) and the front part (102) of pusher, being able to insert a stiletto (11) through it so that it is adjusted but with freedom of movement.

In the preferred embodiment, the main body (101) serving as a handle is cylindrical but larger in diameter than the front part (102), there being between them a conical trunk region (104).

In accordance with Figure 2, the mode of use of the tool (100) in the device (4) is observed, which comprises a connector block (1) that is coupled to the pulse generator housing (3), housed in inside one or more electrode connections (6) to the battery and

circuit of said generator (3), where at least one auxiliary port (9) is provided that gives access to said electrode connections (6).

The stylus end (11), previously threaded 5 into the tool (100), is inserted through the auxiliary port (9). When the stylet (11) is in contact with the internal conductor of the electrode to be replaced, a way is achieved to have unipolar stimulation through the use of an analyzer.

Sliding the tool (100) over the stylet (11) and introducing the front part 10 (102) or pusher through the same auxiliary port (9) provides mechanical thrust to the

electrode in case of adhesions or some degree of blockage.

Describing sufficiently the nature of the present invention, as well as the way of putting it into practice, it is not considered necessary to extend its explanation so that any expert in the field understands its scope and the advantages that derive from it, stating that , within its essentiality, may be implemented in other embodiments that differ in detail from that indicated by way of example, and to which it will also achieve the protection that is sought provided that it is not altered, changed or modified its principle fundamental.

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Claims (4)

5 10 fifteen twenty 25 ES 2 630 729 A1 R E I V I N D I C A C I O N E S 1. - SPECIFIC TOOL FOR USE IN REPLACEMENT INTERVENTIONS OF IMPLANTABLE ELECTRICAL STIMULATION DEVICES EQUIPPED WITH AUXILIARY PORT characterized by comprising a main body (101) of insulating material, configured as a handle, which has a front part (102) of pusher , of the same material, whose outer width (D) is appropriate to allow its insertion in the auxiliary port (9) of the device (4) and to exert thrust on the distal end of an electrode (6), there being a longitudinal conduit (103) , which crosses both the main body (101) and the front part (102) of the pusher, suitable for inserting through it a semi-rigid stylus (11) so that it is adjusted but with freedom of movement. 2. - SPECIFIC TOOL FOR USE IN REPLACEMENT INTERVENTIONS OF IMPLANTABLE ELECTRICAL STIMULATION DEVICES EQUIPPED WITH AUXILIARY PORT, according to claim 1, characterized in that the main body (101) and the front part (102) of the pusher is made of plastic. 3. - SPECIFIC TOOL FOR USE IN REPLACEMENT INTERVENTIONS OF IMPLANTABLE ELECTRICAL STIMULATION DEVICES EQUIPPED WITH AUXILIARY PORT, according to claim 1 or 2, characterized in that the front part (102) Pusher is cylindrical. 4. - SPECIFIC TOOL FOR USE IN SPARE PARTS OF IMPLANTABLE ELECTRICAL STIMULATION DEVICES EQUIPPED WITH AUXILIARY PORT, according to claim 3, characterized in that the main body (101) serving as a handle is cylindrical, larger in diameter than the front part ( 102), there being a truncated conical zone (104) between them.