WO2012168378A1

WO2012168378A1 - Implantable bipolar cardiac stimulation probe with auxiliary stimulation pole and method of producing such a probe

Info

Publication number: WO2012168378A1
Application number: PCT/EP2012/060818
Authority: WO
Inventors: Marc Bemurat; Diane Bemurat; Eliane Bemurat; Laurent Bemurat
Original assignee: Marc Bemurat; Diane Bemurat; Eliane Bemurat; Laurent Bemurat
Priority date: 2011-06-10
Filing date: 2012-06-07
Publication date: 2012-12-13
Also published as: FR2976182B1; FR2976182A1

Abstract

The subject of the invention is a cardiac stimulation probe with auxiliary pole (10), comprising at least one first conductor (1) linked to a first contact (4) of a connector (5) for linking the probe to a stimulator casing, for which the auxiliary pole (10) is linked to the first contact (4) by an auxiliary conductor (3) parallel to the first conductor (1), characterized in that the connector (5) comprises an insulating body (51), covering at the level of the connector (5) a cable (30) for linking the connector to the stimulation electrode (101) of the probe and being extended, on the opposite side to the first contact (4), by a sleeve (52) comprising a housing (53) of an auxiliary contact (11) for receiving a stimulation stylus (20) and by an output of the cable (30).

Description

BIPOLAR PROBE OF IMPLANTABLE CARDIAC STIMULATION WITH AUXILIARY STIMULATION POLE AND METHOD OF MAKING SAME

FROM SUCH A PROBE

The present invention relates to an implantable pacemaker bipolar cardiac stimulation catheter and its method of production.

It relates more particularly to a ventricular pacing probe. An example of an auxiliary pole probe, also called an accessory pole, is given in the document FR 2 869 807 A1 in the name of the present applicants.

This device makes it possible, during the replacement of the pacemaker box, to connect the already implanted probe to an external stimulator by means of the auxiliary pole before disconnecting the probe from the stimulator to be replaced and thus to eliminate any interruption of the stimulation in the dependent patients. ventricular.

During this operation, the ventricular probe already implanted is preserved.

Case replacement in a patient who has become dependent may be difficult.

It was recognized that 10% of patients are dependent at the time of casing replacement ie that these patients have no autonomous rhythm; recent work shows that all patients who may temporarily lose this autonomous rhythm must be considered dependent, which is a much higher percentage.

The presence of an accessory stimulation pole on the ventricular probe therefore brings a very high level of security at the time of the case replacement and it offers the same comfort as a temporary ventricular pacing probe, without the difficulties of setting up such a temporary probe.

For this prior embodiment, the auxiliary pole is formed by means of a y-branch allowing a conductive wire to emerge from a coil of connection wires of the probe and to connect it to a female contact element.

The auxiliary pole of such a probe implanted in a patient makes it possible to connect the heart of the latter to an external device during the replacement of its pacemaker or an intervention on the latter.

To do this, a stylet having a connection end with the external device is inserted into the female contact of the auxiliary pole itself connected to a probe stimulation electrode.

This prior embodiment is satisfactory but it is sometimes longer to access the Y branch of the auxiliary pole, the size and the profile of the probe being conducive to being retained by fibrosis.

Document FR 2 851 169 in the name of the present applicants relates to a monopolar probe also comprising a Y-branch terminated by an auxiliary contact.

The present invention aims to improve such probes to make the auxiliary pole easier to access, to reduce their size, make them easier to use and improve the contact at the stylus connecting to the auxiliary pole.

It is further designed to enhance contact with an external stimulation stylus.

Its use is extremely simple, since it is sufficient to extract the housing, to access the accessory or auxiliary stimulation pole which is located at the output of the connector IS1, to introduce a mandrel or stylet and to fix on this mandrel a crocodile clip connected to the external stimulator, the mandrel once introduced being perfectly stable in the auxiliary contact.

To do this, the present invention provides an auxiliary pole heart pacing lead having at least a first lead connected to a first contact of a lead connector of the lead to a stimulator housing, for which the auxiliary pole is connected to the lead. first contact by an auxiliary conductor parallel to the first conductor and for which the connector comprises an insulating body, covering at the connector a connecting cable of the connector to the probe stimulation electrode and extending, opposite to the first contact, by a sleeve having a housing of an auxiliary receiving contact of a stimulation stylet and through a cable outlet.

Due to the configuration of the probe according to the present invention for which the sleeve is at the end of the connector of the probe to the housing, connector called IS1, the stimulator has every opportunity to connect the stylus to the back of the connector of the probe connected to the housing, to work if necessary on the pocket and replace the case; the external stimulation can be stopped only when the new housing is connected and ready to be re-buried, any risk of cardiac arrest being thus removed.

The new probe offers compared to the current probe the advantage of having an auxiliary pole very easily accessible thanks to the disappearance of the branch Y.

Preferably, the orientation of the output of the auxiliary contact is in a direction opposite to the direction of insertion of the connector into the stimulator.

This orientation added to the fact that the sleeve extends the connector IS1 facilitates the introduction of the stylus by the practitioner who can hold the stimulation box in one hand and the stylus in the other hand and easily position the stylus in its housing to the back of the IS1 connector.

On the other hand, it makes it easier to extract the probe from the patient's tissues when the pacemaker is extracted, the sleeve flaring towards the back of the IS1 connector that does not offer a grip or roughness. opposing the exit of the probe during the extraction of the pacemaker even in case of fibrosis covering the probe.

Preferably, the auxiliary contact is disposed in the sleeve parallel to the cable of the probe connecting the connector to the stimulation electrode.

The sleeve is advantageously an insert or an enlarged portion of the insulating body.

According to a preferred embodiment, the auxiliary contact is connected to the auxiliary conductor by means of a ring disposed on the connecting cable to which the auxiliary conductor is connected. Advantageously, the conductive core of the auxiliary conductor is welded to the ring.

According to a particular embodiment, the auxiliary contact is electrically connected to the ring by a metal wire covered by the sleeve.

The wire is advantageously a flat wire welded at both ends on the one hand to the ring and on the other hand to the auxiliary contact.

Alternatively, the wire is a tail of the auxiliary contact welded to the ring.

According to an advantageous embodiment, the contact is a tubular female contact with internal spring blade.

The housing preferably comprises at least one septum protection of a pen input channel in the housing.

The invention is also particularly applicable to a bipolar collinear winding probe, the auxiliary conductor being wound collinearly with the conductors of the probe to the auxiliary pole.

The invention further relates to a method for producing a stimulation probe which comprises the steps of sliding a ring on the probe under construction, before mounting the connector on the cable insulation to the output of the pole wire. auxiliary,

disengage this wire and perform a solder thereby electrically bonding it to the ring;

soldering the auxiliary contact previously equipped with its contact tab and held by a wire.

then comb the whole with the sleeve without sticking it;

mount the IS-1 connector of the probe and equip it with its silicone molding to make the insulating body of the connector.

The method further advantageously comprises a step of polymerization of the body followed by a step of adjusting the sleeve to the connector of the probe.

To reserve the path of the stylus and the housing of the seals, the method preferably comprises a step of introducing a pseudo stylus made of a teflon rod into the contact of the auxiliary pole and a silicone glue injection step inside the sleeve so as to completely fill the interstices, a polymerization step and a step of sizing the housing of the joints and introduction of the joints.

Other characteristics and advantages of the invention will become apparent on reading the following description of non-limiting examples of the invention with reference to the drawings which represent:

in Figures 1A and 1B: respectively a side view of a probe of the prior art devoid of auxiliary pole and a probe according to the invention;

in Figure 2: a partial sectional view of a probe according to the invention and the winding of conductors facing;

in Figure 3: a sectional view of a detail of the probe of Figure 2;

in FIG. 4: a view from the rear of the sleeve of the probe of FIG. 2; FIGS. 5A and 5B are sectional views of two embodiments of an auxiliary contact applicable to the invention.

Pacemaker probes are devices implanted in the human body connecting a pacemaker to a ventricle of a wearer's heart.

One of the particular difficulties in the field of surgical implantation is the propensity of the tissues to penetrate and enclose implanted foreign bodies as well as the production of fibrosis which will cover and attempt to penetrate these foreign bodies.

Stimulation probes between a pacemaker and the heart of a pacemaker wearer include a standard connector at the pacemaker called the IS-1 connector.

An example of a probe of the prior art A is shown in FIG. 1 A.

Such a probe comprises a connector C whose contacts C1 and C2 are inserted in a pacemaker of known type.

The present invention proposes to make an auxiliary pole from the end of the connector portion whose dimensions, and in particular the length L of Figure 1 A, are imposed by the IS-1 standard.

A probe of the invention of the bipolar type is shown diagrammatically in FIG. 1B with left to right, the distal contact 4, the proximal contact 6, the insulating body 51 of the connector to the stimulator and then the connecting sleeve 52 of the auxiliary pole and output of the cable 30 for connecting the stimulation electrode 101 with the stimulator.

The connector at the level of the stimulator is somewhat elongated compared to the original used in particular on the probes produced by the company Somédics but this elongation will remain modest since it is only 4.5mm or 5mm for a length of connector without auxiliary pole of the order of 41 mm.

The pacemaker probe 100 with an auxiliary pole 10 according to the invention as represented in FIG. 1B has a main axis 1 10 on which are aligned the first contact 4, distal contact, the second contact 6, proximal contact, and the output of the cable 30 going to the electrode 101.

The insulating body 51 which in the case of the invention is extended by a sleeve 52 comprising the auxiliary pole 10 and the output of the cable 30.

According to FIG. 2, the sleeve 52 comprises at the auxiliary pole a housing 53 for receiving a female auxiliary contact 1 1 shown in FIG. 3 intended to receive a stylet 20 for electrically connecting it with the distal contact 4.

The sleeve which covers at the connector 5 the connection cable 30 of the connector to the stimulation electrode 101 of the probe extends the insulating body opposite the first contact 4.

In the lower part of FIG. 2 are shown, in the case of a bipolar collinear winding probe, that is to say for which the wires parallel to each other are wound around a common axis, the conductors being at the level of connector.

Such a probe comprises at least a first conductor 1 connected to a first contact 4 of the connection connector 5 of the probe to the stimulator housing.

The auxiliary pole 10 is connected to the first contact 4 by an auxiliary conductor 3 parallel to the first conductor 1.

A conductor will be referred to as an electrical wire having a conductive core and an insulating coating.

The probe chosen to be so equipped is, according to the example, a bipolar probe which mainly comprises a cable whose conductors are wound collinearly, ie a conductor 1 connected to the distal contact 4 and a conductor 2 connected to the proximal contact 6, the juxtaposed conductors being wound around a common axis and covered with an overall insulating sheath.

The advantage of a collinear conductor cable with respect to a coaxial conductor cable comprising a central wire and a braided wire around the central wire is to provide a cable of great flexibility and relatively extensible.

An auxiliary pole according to the invention is obtained by adding a winding comprising the additional conductor 3 starting from the distal portion of the connector to directly connect the connection of the auxiliary pole.

At the contact 4, the conductors 1 and 3 are stripped to make the electrical connection as well as the conductor 2 at its stripped end to make an electrical contact with the contact 6.

At the sleeve 52, the conductor 3 has a stripped end 3b welded to a ring 12 disposed on the conductors 1 and 2 provided with their insulating sheath. The ring 12 may in particular be a platinum ring, metal compatible with implantation in the human body.

The cable 30 downstream of the ring comprises an additional insulating sheath 31 maintaining the winding of the conductors 1 and 2.

In the lower part of FIG. 2 are marked the conductors of the collinear winding, the conductors 1 and 3 being wound together from the contact 4 to the contact 6, the conductors 1, 3 and 2 are wound together from the contact 6 to the ring and then the conductors 1 and 2 form the conductors of the cable 30 which goes to the electrode.

Returning to Figure 2, the upper portion has a housing 53 which will receive a female contact of the auxiliary pole.

FIG. 3 represents the sleeve 52 equipped with this female contact January 1.

The female contact 1 1 is connected to the ring 12 by a wire 13, here a folded flat wire for making two bonding zones by welding, laser welding for example, one with the ring and the other with the body of the female contact. .

The female contact is here a spring leaf contact 14c which comprises two blades facing in a tube.

The tube of the female contact can be made by rolling cut, the wire 13 can also be made by a tail cut in the blank of embodiment of the tube of the female contact and secured to the tube of the female contact and the spring blades reported.

The tube can be made of stainless steel AISI 316L, the leaf spring MP 35 N alloy two metals with no incompatibility for implantation.

The female contact 1 1 of the auxiliary pole, firmly held in its silicone housing 53 has been studied and tested in order to obtain virtually zero ohmic resistance contact while ensuring accurate retention of the stylus introduced.

The sealing of the entry of the stylus is ensured by the presence of two silicone septum seals 15 of known type which prevents the entry of body fluids into the housing when the stylet is not inserted into the contact 1 1.

In FIGS. 5A and 5B are described two variants of the female contact provided with a single spring contact blade, the variant of FIG. 5A comprising a blade 14a bearing against the bottom of the contact tube January 1 and held in position. tube inlet by a flap, the variant of Figure 5B having a blade 14b welded to the tube inlet and provided with a distal end free to slide in the tube during the introduction of the stylet 20 shown in Figure 5A .

FIG. 4 shows the sleeve 52 seen on the entry side of the stylet with the inlet of the housing closed by the seal 15 and the exit of the cable 30.

In this configuration for which the pen input is disposed near the pacemaker connector, near the cable 30 and parallel to this cable, the practitioner will have no difficulty in finding the location for the introduction of a stylus pen. external stimulation during an intervention on the pacemaker and take control of the unipolar stimulation.

To achieve the probe, for example, as follows.

On the probe under construction, before mounting the connector slide the platen ring 12 on the polyurethane insulation of the cable 30 to the output of the wire of the auxiliary pole.

Remove this wire and perform a laser weld binding it and electrically on the platinum ring.

Then weld (always laser) the female contact 12 previously equipped with its contact and holding tab made by the wire 13.

Then style the assembly with the molded silicone part without sticking it. Fit the IS-1 connector of the probe and equip it with its silicone molding to make the body 51.

Allow to cure 12 hours.

Then return to the silicone cap of the auxiliary pole forming the sleeve 52, adjust it to the connector of the probe.

Introduce a stylus stylus made of a teflon rod into the contact of the auxiliary pole to reserve the path of the stylus and seals.

Inject the silicone glue into the interior of the cap so as to completely fill the gaps.

Allow to cure 12 hours.

Glue the housing of the joints and introduce them.

Due to this arrangement, the reliability of the probe is perfectly preserved and the auxiliary pole has a very low contact resistance.

The sleeve 52 may be an insert but may also be an enlarged portion of the insulating body 51.

All the materials chosen for the probe are materials compatible with implantation in the human body.

The stylet is in known manner a spring wire which can be connected to an external stimulation device by means of an electric cable terminated by a crocodile clip or any other means.

The present invention, which is particularly adapted to bipolar ventricular probes, therefore offers more immediate access to the accessory or auxiliary pole than previous probes, minimizes the additional equipment implanted, retains the flexibility of the cable and the connector, the profile of the probe of the present invention. invention also offering no grip on fibrosis.

In addition, in the case of a collinear bipolar probe, the construction of the base probe is not modified, the accessory pole being simply added to the end of the connector.

The invention is not limited to the example described and is particularly useful in the context of a unipolar probe or a coaxial cable probe, this invention may also be applied to ear probes or defibrillator probes .

Claims

R E V E N D I C A T IO N S

1 - Pacemaker probe (100) with auxiliary pole (10), comprising at least a first conductor (1) connected to a first contact (4) of a connector (5) connecting the probe to a pacemaker box for which the auxiliary pole (10) is connected to the first contact (4) by an auxiliary conductor (3) parallel to the first conductor (1) in the connector,

characterized in that the connector (5) comprises an insulating body (51) covering at the connector (5) a cable (30) for connecting the connector to the stimulation electrode (101) of the probe, said insulating body extending and terminating at the output of the connector, opposite the first contact (4), by a sleeve (52) having a housing (53) of an auxiliary contact (1 1) for receiving a stylet (20) of stimulation and an output of the cable (30) for connecting the connector to the probe stimulation electrode.

2 - pacing lead (100) according to claim 1 characterized in that the orientation of the output of the auxiliary contact is in a direction opposite to the direction of introduction of the connector in the stimulator.

3 - Stimulation probe according to claim 1 or 2, characterized in that the auxiliary contact (1 1) is disposed in the sleeve (52) parallel to the cable (30) of the probe connecting the connector to the stimulation electrode.

4 - Stimulation probe according to claim 1, 2 or 3, characterized in that the sleeve (52) is an insert or an enlarged portion of the insulating body (51).

5 - Stimulation probe according to any one of the preceding claims, characterized in that the auxiliary contact (1 1) is connected to the auxiliary conductor (3) by means of a ring (12) disposed on the connecting cable (30). ) to which the auxiliary conductor (3) is connected.

6 - Stimulation probe according to claim 5, characterized in that the conductive core of the auxiliary conductor (3) is welded to the ring.

7 - Stimulation probe according to claim 5 or 6, characterized in that the auxiliary contact (1 1) is electrically connected to the ring (12) by a metal wire (13) covered by the sleeve. 8 - Stimulation probe according to claim 7, characterized in that the wire (13) is a flat wire welded at both ends on the one hand to the ring (12) and on the other hand to the auxiliary contact (1 1 ).

9 - Stimulation probe according to claim 7, characterized in that the wire (13) is a tail of the auxiliary contact welded to the ring

(12).

10 - Stimulation probe according to any one of the preceding claims, characterized in that the auxiliary contact is a tubular female contact with internal spring blade (14a, 14b, 14c).

1 1 - Stimulation probe according to any one of the preceding claims, characterized in that the housing (53) comprises at least one septum (15) for protecting a pen input channel (20) in the housing (53).

12 - Stimulation probe according to any one of the preceding claims, characterized in that the probe is a bipolar collinear winding sensor, the auxiliary conductor (3) being wound collinearly with the conductors (1, 2) of the probe until at the auxiliary pole (10).

13 - A method of producing a stimulation probe according to any preceding claim characterized in that it comprises the steps of sliding a ring on the probe in construction, before mounting the connector on the cable insulation 30 until the output of the auxiliary pole wire,

soldering the auxiliary contact (12) previously equipped with its contact and holding tab made by a wire (13).

then comb the whole with the sleeve without sticking it;

mount the IS-1 connector of the probe and equip it with its silicone molding to make the body (51).

14 - Process according to claim 13 comprising a step of polymerization of the body followed by a step of adjusting the sleeve (52) to the connector of the probe.

15 - The method of claim 13 comprising a step of introducing a pseudo stylus made of a teflon rod in the contact of the auxiliary pole to reserve the path of the stylus and seals and a step of injection of Silicone glue inside the sleeve in order to fill integrally the interstices, a polymerization step and a step of sizing the housing of the joints and introduction of the joints.