FR2654348A1 - METHOD AND DEVICE FOR THE EXTRACTION OF HELICOUIDAL ELECTRODES INTEGRATED IN A BODY ORGAN. - Google Patents

Abstract

To extract helical electrodes integrated in a body organ, a thin traction element (3) is introduced into the interior cavity (4) of a helical electrode (10), up to the proximity of the head thereof. A tensile strength bond is then established between the head (K) of the tensile element and the wall (W) of the electrode (10). A tensile force is then applied to the electrode (10) until it detaches from the body planting site.

Description

The present invention relates to a process ap-

  bent to a helical electrode integrated by its head into a body organ, in order to generate a tensile force in

  view of the extraction of said electrode.

  A frequently applied method of removing defective or infected pacemaker electrodes from the body is known as "continuous tensile stress" during which the electrode is put

  naked in the pocket of the pacemaker, then is requested

  ted by a continuous tensile stress of about 0.98 N to about 4.9 N, for hours and days, until

  that the electrode detaches from interwoven growths

  sular By means of a cable guidance system, a weight

  imposes a tensile stress on the electrode.

  A disadvantage of this method is that the continuous tensile stress must often be applied for several days, in which case the patient must remain

  connected to the traction device, and stay in bed.

  To extract stimulation electrodes

  Integrated cardiac readers, defective or infected, it is also known to use a serpentine catheter, a serpentine being then threaded and fixed to the electrode of the cardiac catheter, up to the implantation site A pulling force

  can then be directly applied in front of this site.

  One drawback of these well-known and widely used procedures is that a serpentine catheter should not be used in the presence of pacemaker bags or catheter electrodes.

  infected heart because threading the snake catheter

  tin, on the electrode, can result in the propagation of germs in the heart When the stress of

  continuous traction, long and forced bed rest affects heavy-

  the patient's condition, both mentally and physically.

  The object of the invention is to facilitate the extraction of helical electrodes integrated into a body organ, already implanted and defective or infected. The tensile force necessary for this purpose must be applied directly to the implantation site, and it should exclude an infection of the body organ resulting, for example, from a spread of germs that can be caused, for example,

  by threading the extractor device.

  In accordance with the invention, to achieve this object

  jet, an extraction process is proposed by introducing a thin traction element into the interior cavity of the helical electrode, up to the proximity of the head of the electrode; by then establishing, mechanically or by shape matching, a tensile-resistant connection

  between the head of the traction element and the wall of the elect

  helical trode; and by subjecting the helical electrode to an individually applicable tensile force, until said electrode detaches from the implantation site in

the bodily organ.

  Other characteristics of the invention consist in that the connection, between the head of the traction element and the wall of the helical electrode, takes place by expansion

  localized from said head to a diameter greater than that

  him from the inner cavity Variants of this operating mode-

  roof can still consist in that the connection, between the

  head of the traction element and the wall of the electrode

  licoidal, takes place by anchoring by matching shapes with

  the wall of the interior cavity; or that the connection

  sound, between the head of the traction element and the wall of the helical electrode, takes place by localized expansion of

  said head to a diameter greater than that of the cavi-

  inner tee, and by anchoring by matching shapes with

the wall of said cavity.

  Another fundamental embodiment of the project

  ceded allows a significantly improved handling, and a more adequate connection with the helical electrode, because the connection between the head of the traction element

  and the wall of the helical electrode, takes place by sliding-

  relative relative, in the axial direction of the propeller, of an

  dull guided in the envelope of the traction element.

  To prevent damage to the body organ or the heart, in the presence of excessively integrated electrode heads, and to be able to terminate the extraction process at any time, another mode of realization of the

  method according to the invention consists in that the bond resists

  both in traction, between the traction element and the interior cavity of the helical electrode, can be eliminated

  by an intervention by acting through the cor-

  internal donation, mechanically or by shape matching, on

  the head of the traction element.

  In another embodiment of the invention, the connection, established between the internal cord and the head of

  the traction element, can be removed when the

  of a basic magnitude of the tensile force In a variant of the operating mode, this can also be ensured

  by the fact that the connection, between the internal cord and the head-

  te of the traction element, is removed by their relative rotation around the axis of the propeller; or by the fact that the connection, between the head of the traction element and the

  wall of the helical electrode, is removed by sliding

  internal cord relative to the element envelope

  tensile, in the axial direction of the propeller.

  The procedures according to the invention mean

  trust respectively a significantly easier intervention,

  for the doctor or the surgeon, and both physical and

  that psychic for the patient According to the teachings in accordance with the invention, the extraction of integrated electrodes is also carried out with safety and simplicity

  larger because, at the same time, we avoid

  inadequate breastplates and we remove to a large extent the

complexity of equipment.

  The invention also relates to devices

  harmful for the implementation of the process according to the invention

  tion, the basic realization presenting a trac-

  tion can be introduced into the interior cavity of

  the helical electrode, and provided with an expandable or de-

  foldable A simple embodiment of the device

  resists in that at least two barbs, formed on the head

  connected to the traction element, are subject to low pre-

  load in the direction of spreading, and hang in the wall of the interior cavity during a reversal of the direction

  of movement of the traction element.

  A significant embodiment of the device consists, first of all, in that the traction element consists of an envelope to which a head is fixed, and an internal cord which can slide longitudinally in said

  envelope This improvement gives the device a

  excellent niab ility, since the internal cord

  performs specific adjustment functions and

adjustment.

  A first embodiment consists in that the head of the traction element is provided with at least two barbs arranged on a deployable end piece, and which can be removed by relative sliding of the internal cord. According to a second embodiment, provision is made for the head of the traction element to have a wedging sleeve on which at least two separable spouts are arranged; and that an expandable body, fixed at the end of the internal cord, engages during a longitudinal sliding in the slot

  between the spreadable spouts, and press these

  niers against the helical electrode wall Also,

  a third variant can be carried out in a par-

  particularly advantageous, so that the head of

  the traction element contains a chamber intended to receive

  see at least two barbs which are formed on a tip

  deployable connected to the traction element, can be

  bent by preload, and can be released

  res, by expulsion from the chamber, after sliding

  latif between the traction element and the head of this element.

  Finally, an additional proposal makes it possible to perfect this-

  te last embodiment by arranging the end piece

  pliable with faculty of dissociation from the end of

the traction element.

  In accordance with the invention, the aforementioned chamber pre-

  advantageously feel passage openings directed into the

  axial direction of the propeller and intended for retractable nozzles or

  grooves formed on the deployable endpiece, orifices through which, during a relative sliding between the traction element and its head, said beaks or barbs can be

  expelled and deployed, then retracted again.

  These various embodiments, which allow

  still other variations and also some refinements

  are based on one of the fundamental ideas of the

  vention consisting, by introducing the traction element with a head in the interior cavity of the electrode, to realize this head in such a way that it applies or gets stuck, respectively grips or S 'hooks mechanically or by concordance of shapes against the internal wall of the helical electrode; this results in a connection that is at least tensile-resistant to the extent that it makes it possible to apply by hand a tensile force which can be measured and exerted

  individually, specifically to make this app work

  cation in close proximity to the implantation area in the body. The presence of the internal cord, in the traction element, allows first of all to activate the elements

  can have different configurations, and therefore

  quent to connect them to the inner wall of the inner cavity of the electrode, in order to pass on the traction force on

  this electrode in the desired locations.

  A handle and a retaining ring, provided for actuating the device, are respectively connected to the

  internal cord and to the envelope of the traction element.

  The invention will now be described in more detail by way of non-limiting examples, with reference to the appended drawings in which: FIG. 1 is a section of the device according to

  the invention, in its simplest embodiment, during the

  troduction in the helical electrode Figure 2 shows the device according to Figure 1, hooked in the helical electrode Figure 3 is a section of the device provided with a traction element, according to another embodiment, during the introduction into the helical electrode; FIG. 4 illustrates the device according to FIG. 3, hooked into the helical electrode; Figure 5 shows the device according to another

  realization, during the introduction into the helical electrode

  dale; Figure 6 is a section of the device according to Figure 5, hooked into the helical electrode;

  FIG. 7 is a section through a variant embodiment

  tion of the device according to FIG. 6, in the introduction phase

  of the traction element when the spreadable or ardill-

  lons are still retracted; and FIG. 8 shows the device according to FIG. 7,

  whose spreadable spouts are deployed.

  Figures 1 and 2, illustrating an embodiment

  tion of the device according to the invention, show in dry section-

  a helical electrode 10 and a traction element

  3 which is introduced into an interior cavity 4.

  At the end of the traction element 3, there is a head K to which are attached barbs 6 at least at

  number of two, preferably three or four.

  The layout and construction are such that, under the effect

  with a permanently acting force, these barbs 6 have tended to

  dance to fan outwards Preferably,

  the head K of the traction element and the barbs 6 are made

  made of plastic, and made in one piece.

  The configuration can then be studied so that

  the barbs are subjected to a tension of tension acting

  sant permanently During the introduction into the helical electrode, they are applied against walls W of the latter by opposing the aforementioned tension If now, after the extreme position of the head K has been reached proximity to the implantation site of the helical electrode,

  a pulling movement is printed in a direction A op-

  laid in the direction of introduction E, the barbs 6 catch on

  to the wall W of the interior cavity 4 of the helical electrode

  cordal, and they get stuck so that a pulling force

  can be applied to the electrode For handling

  pulation, the traction element 3 is provided with a handle 8

drilling a grip hole 9.

  The embodiment can also be arranged in such a way that the head K is not connected irremovably to the traction element 3 by a deployable end piece 5, but that the connection is established only mechanically, and

  dissociates when exceeding a tensile force li-

  mite planned; this limit tensile force can be studied

  diée so as to avoid lesions in the implantation area

tion of the patient's body.

  The comments below relate to the shapes

  according to FIGS. 3 to 8.

  The device is introduced by the trac-

  tion 3, in the direction of introduction E, in the internal cavity

  4 of a helical electrode 10 consisting, for example,

  ple, into a exposed cardiac catheter electrode

  pocket sinage of the pacemaker.

  The traction element 3 visible in FIGS. 3 to

  8 consists of an internal cord 1 which can slide along

  linearly in an envelope 2 of the traction element La

  head K, fixed to said envelope 2, is animated by a slide-

  lie to the vicinity of the implantation site in the heart.

  In the exemplary embodiment illustrated in the figures

  Figures 3 and 4, the traction element 3 consists of an expansible body 14 which is spherical or even conical, and of a

  wedging bush 17 having spout 16.

  When inserting the traction element 3 in the direction of insertion E, as shown in FIG. 3, the expandable body 14 is spaced from the bush 17 by a distance of

  setting k, and the spouts 16 have, transversely relative to

  port to the axis X of the propeller, a geometric dimension smaller than the diameter d of the internal cavity 4 When the expandable body 14 is applied against the end of the electrode

  helical 10, a movement is printed on the handle 8 to-

  the gap of a retaining ring 7, in the direction of traction R, so that said body 14 is directed towards the socket 17, by means of the cord 1, and that the spouts 16 are deployed following the enlargement d 'a longitudinal slot 15, and apply respectively by pressure against the electrode 10 or against

  the walls W of the latter, as shown in FIG. 4.

  It can be seen that these walls W are deformed under the effect of

  nozzle pressure 16 When pulling on the device ex-

  tractor, in the direction of expulsion A, a traction force is applied to the pacemaker catheter at the implantation site The envelope 2 of the traction element and the

  clamping sleeve 17 preferably constitutes only one

  the part with the spreadable spouts 16.

  In an alternative embodiment according to Figures and 6, a protective chamber 11 is provided at the end of the casing 2 of the traction element and, as shown

  In FIG. 5, the end of the internal cord 1 presents an em-

  extendable end 5 to which barbs 6 are fixed to the ma-

  nière of an umbrella The retaining ring 7 is located at the other end of the casing 2, while the cord 1 is connected to the handle 8 A mutual approximation of the ring

  7 and the handle 8 has the effect of sliding the cor-

  don 1 relative to the envelope 2, and to slide, out of the chamber 11, the deployable end piece 5 with the barbs 6 which are fixed to it, said barbs 6 then deploying in the manner of an umbrella. reverse motion

  between the cord 1 and the envelope 2, the barbs 6 applied-

  against the wall W of the interior cavity 4 will meet a

  resistance and will cling together, so that a bond resists

  both in tension is thus established between element 3 and electrode 10, and that it becomes possible to extract this

last in hand.

  Another variant is illustrated in Figures 7

  and 8 In this case, the protective chamber 11 is integral-

  ment closed, but is however pierced with through holes 13 which are respectively associated with each pin 6 or each retractable spout 16, and which are arranged and configured so that, after the deployable endpiece 5 has reached its position most advanced end in said chamber 11,

  and after a consecutive reversal of the movement of the cord

  dull 1 relative to the envelope 2 of the traction element,

  the barbs 6 (respectively the retractable spouts 16) trav-

  pour the passage openings 13, and are thus spaced outwardly coming to bear against the wall W of the interior cavity 4 Just as in the illustration of FIGS. 4 and 5, the pressure thus exerted against the wall W is then expressed by the deformation of the latter, and by the establishment of the mechanical connection or by concordance of

  shapes with the helical electrode 10.

  An essential advantage then consists in that,

  te a relative sliding of the internal cord 1 relative to the casing 2 of the traction element opposite the direction

  traction, i.e. in direction E (Figure 7), a re-

  traction of the barbs 6 or of the spreadable spouts 16 deployed can occur, and the device can be respectively

  extracted or removed by traction exerted on the retaining ring

  nude 7 It is, in addition, offered the additional possibility

  consisting in making the connection, between the cord 1 and the em-

  extendable end 5, so that this connection dissolves

  cie when a limit value of the tensile force is exceeded. It goes without saying that many modifications can

  be made to the invention as described and shown

without departing from its framework.

Claims (16)

-R E V E N D I C A T I O N S-   1 Method applied to an internal helical electrode   incorporated by its head into a bodily organ, in order to generate   a tensile force for the extraction of said elec-   trode, process characterized by the introduction of a thin element   traction (3) in the interior cavity (4) of the elect   helical trode (10), up to near the head of the elect   trode; by the subsequent establishment, mechanically or by shape matching, of a traction-resistant connection between the head (K) of the traction element and the wall (W) of   the helical electrode (10); and through the application, to the elect   helical trode (10), of an individually applicable tensile force, until said electrode detaches   of the site of implantation in the body organ.   2 Method according to claim 1, characterized in that the connection, between the head (K) of the traction element and the wall (W) of the helical electrode (10), has   place by localized expansion of said head to a diameter   be greater than that (d) of the interior cavity (4).   3 Method according to claim 1, characterized in that the connection, between the head (K) of the traction element and the wall (W) of the helical electrode (10), takes place by anchoring by matching shapes with the wall (W) of the interior cavity (4).   4 Method according to claim 1, characterized in that the connection, between the head (K) of the traction element and the wall (W) of the helical electrode (10), has   place by localized expansion of said head to a diameter   be greater than that (d) of the interior cavity (4), and by anchoring by concordance of shapes with the wall (W) of said cavity.   Process according to any one of Claims 1 to 4, characterized in that the connection, between the   head (K) of the traction element and wall (W) of the elect   helical trode (10), takes place by relative sliding, in the axial direction (X) of the propeller, of an internal bead (1) guided   in the envelope (2) of the traction element.   6 Method according to claim 5, characterized by   the fact that the tensile bond between the element   traction (3) and the interior cavity (4) of the electro-   helical (10), can be removed by an intervention by acting via the internal cord (1), mechanically or by matching shapes, on the head (K) of the traction element.   7 Method according to claims 4 and 5, charac-   terrified by the fact that the connection, established between the cord   internal (1) and the head (K) of the traction element, is sup-   awarded when exceeding a basic quantity of force traction.   8 Method according to claims 4 and 5, charac-   terrified by the fact that the connection, established between the cord   internal (1) and the head (K) of the traction element, is sup-   awarded by their relative rotation around the axis (X) of the he running.   9 Method according to claims 4 and 5, charac-   terrified by the fact that the connection, established between the head (K)   of the traction element and the wall (W) of the helical electrode   coidal (10), is removed by sliding the inter-   ne (1) relative to the envelope (2) of the traction element,   in the axial direction (X) of the propeller.   Device for implementing the method   according to any one of claims 1 to 9, device   characterized by a traction element (3) which can be inserted   produced in the interior cavity (4) of the helical electrode   plate (10), and provided with an expandable or deployable head (K).   11 Device according to claim 10, character-   laughed at by the fact that at least two barbs (6) formed on the head (K) connected to the traction element (3) are subjected to   a small preload in the spreading direction, and   hook into the wall (W) of the interior cavity (4) when the direction of movement of the traction element is reversed (3).   12 Device according to claim 11, character-   laughed at by the fact that the traction element (3) consists of an envelope (2) to which a head (K) is fixed, and an internal cord (1) which can slide longitudinally in said envelope.   13 Device according to claim 12, character-   laughed at by the fact that the head (K) of the traction element is provided with at least two barbs (6) arranged on a nozzle   deployable (5), - and can be removed by sliding rela- internal cord (1).   14 Device according to claim 12, character-   laughed at by the fact that the head (K) of the traction element has a wedging sleeve (17) on which at least two separable spouts (16) are arranged; and by the fact that an expandable body (14), fixed to the end of the internal cord   (1), engages during a longitudinal sliding in the window   longitudinal te (15) between the spouts (16), and pres-   if the latter against the wall (W) of the helical electrode The 10).   Device according to claim 14, character-   laughed at by the fact that the casing (2) of the traction element and the wedging sleeve (17) constitute a single piece with the extendable spouts (16).   16 Device according to claim 12, character-   laughed at by the fact that the head (K) of the traction element   closes a chamber (11) intended to receive at least two ar-   dillons (6) which are provided on a deployable end piece (5)   linked to the traction element (3), can be deployed under   the action of a preload, and can be released, by expelling-   sion out of the chamber (11), after relative sliding between   the traction element (3) and the head (K) of this element.   17 Device according to claim 16, character-   laughed at by the fact that the chamber (11) has through orifices (13) directed in the axial direction (X) of the propeller and   intended for retractable nozzles (16) or barbs (6)   located on the deployable end piece (5), holes through which, during a relative sliding between the traction element (3)   and the head (K) of this element, said beaks or barbs may   can be expelled and deployed, then retracted again.   18 Device according to any one of the claims.   tions 10 to 17, characterized in that the end piece deploys   ble (5) is installed at the end of the traction element   (3), with the option of dissociation from the latter.   19 Device according to any one of the claims   tions 10 to 18, characterized in that the internal cord (1) is attached to a handle (8), the casing (2) of the element   traction element being attached to a retaining ring (7).   Device according to claim 19, character-   laughed at by the fact that the handle (8) is pierced with a grip (9).