Source: http://www.patentgenius.com/patent/8712551.html
Timestamp: 2018-08-16 21:18:40
Document Index: 482716369

Matched Legal Cases: ['art 12', 'art 12', 'arts 46', 'art 64', 'art 64', 'art 64']

Mono-body defibrillation probe - Patent # 8712551 - PatentGenius
8712551 Mono-body defibrillation probe
U.S. Class: 607/122; 607/116
Field Of Search: ;607/4; ;607/5; ;607/116; ;607/122
Abstract: A probe including at its distal extremity a tubular flexible sheath core supporting at least a winding forming a shock electrode and connected to an electrical conductor of connection extending in an internal lumen of the sheath core. In one embodiment of the invention, the sheath core extends axially without a solution of continuity in the area supporting the winding. In particular, the sheath core comprises cavities to receive and hold conducting inserts, of homologous size with cavities formed locally close to the ends of the winding, the insert being connected to the interior side to the electrical conductor, and on the external side to the corresponding extremity of winding. A longitudinal slit connects two cavities and allows, by elastic deformation of the sheath core, the introduction into the cavities and in the internal lumen of the unit formed by the final extremity of the electrical conductor beforehand equipped with its two inserts.
1. A method of assembling a medical probe structure with mechanical continuity comprising: providing a mono-body sheath having a sheath core made of an elastic material, wherein thesheath core comprises an external surface, an internal surface, and an internal lumen in contact with the internal surface and extending longitudinally along a length of the sheath core, wherein the sheath core comprises a cavity extending from theexternal surface to the internal lumen; and inserting a conductor into the internal lumen of the sheath core through the cavity, wherein at least a portion of the conductor comprises an outer diameter that is larger than a corresponding portion of thecavity, and wherein inserting the conductor into the internal lumen comprises pressing the conductor against the cavity and causing a temporary elastic deformation of the elastic material of the sheath core.
2. The method of claim 1, further comprising: providing a winding of wire that forms one end of a shock electrode; and electrically connecting the conductor to said winding.
3. The method of claim 2, wherein the winding of wire is positioned proximate to the external surface of the sheath core, and wherein electrically connecting the conductor to the winding comprises connecting the inserted conductor to thewinding through the cavity.
6. The method of claim 2, wherein a length of the cavity is at least as long as a longitudinal length of the winding, and wherein the sheath is continuous on a portion of the sheath that does not include the cavity and is discontinuous on aportion of the sheath around which the winding is positioned.
8. A medical probe comprising: a sheath having a sheath core comprising an elastic material, wherein the sheath core comprises an external surface, an internal surface, and an internal lumen in contact with the internal surface and extendinglongitudinally along a length of the sheath core, wherein the sheath core comprises a cavity extending from the external surface to the internal lumen; and a conductor configured to be inserted into the internal lumen of the sheath core, wherein atleast a portion of the conductor comprises an outer diameter that is larger than a corresponding portion of the cavity, and wherein the conductor is configured to be inserted into the internal lumen by pressing the conductor against the cavity andcausing a temporary elastic deformation of the elastic material of the sheath core.
10. The medical probe of claim 9, further comprising a ring comprising a conductive material, wherein the ring is configured to be coupled to the winding of wire and the conductor and to electrically connect the winding of wire to theconductor.
12. The medical probe of claim 9, wherein a length of the cavity is at least as long as a longitudinal length of the winding, and wherein the sheath is continuous on a portion of the sheath that does not include the cavity and is discontinuouson a portion of the sheath around which the winding is positioned.
14. An implantable medical device comprising: a generator configured to generate one or more energy pulses; and a probe configured to receive the energy pulses from the generator and apply the pulses to a patient, wherein the probe comprises:a sheath having a sheath core comprising an elastic material, wherein the sheath core comprises an external surface, an internal surface, and an internal lumen in contact with the internal surface and extending longitudinally along a length of the sheathcore, wherein the sheath core comprises a cavity extending from the external surface to the internal lumen, and a conductor configured to be inserted into the internal lumen of the sheath core, wherein at least a portion of the conductor comprises anouter diameter that is larger than a corresponding portion of the cavity, and wherein the conductor is configured to be inserted into the internal lumen by pressing the conductor against the cavity and causing a temporary elastic deformation of theelastic material of the sheath core.
15. The implantable medical device of claim 14, wherein the probe further comprises a winding of wire used to form at least a portion of a shock electrode, wherein the winding of wire is configured to be connected to the conductor through thecavity.
16. The implantable medical device of claim 15, wherein the probe further comprises a ring comprising a conductive material, wherein the ring is configured to be coupled to the winding of wire and the conductor and to electrically connect thewinding of wire to the conductor.
18. The implantable medical device of claim 15, wherein a length of the cavity is at least as long as a longitudinal length of the winding, and wherein the sheath is continuous on a portion of the sheath that does not include the cavity and isdiscontinuous on a portion of the sheath around which the winding is positioned.
The present invention relates to "active implantable medical devices" as defined by the Jun. 20, 1990 Directive 90/385/CEE of the Council of the European Communities.
The invention more particularly concerns the family of apparatuses that deliver to the core pulses of high energy (i.e., pulses notably exceeding the energy provided for simple stimulation) to try to put an end to a tachyarrhythmia. Thesedevices are called "implantable defibrillators" or "implantable cardiovertors," it being understood that the invention also covers implantable defibrillators/cardiovertors or defibrillators/cardiovertors/stimulators.
"Implantable defibrillator" or "implantable cardiovertor" devices have two principal parts--a pulse generator, and a probe or a system of probes. The pulse generator monitors cardiac activity and generates high energy pulses when the heartpresents a ventricular arrhythmia that is deemed susceptible to being treated. When the high energy is comprised between approximately 0.1 and 10 J, the therapy is referred to as "cardioversion" and the electric shock is called "cardioversion shock."When the high energy is greater than approximately than 10 J, the therapy is called defibrillation and the electric shock is called "defibrillation shock." The pulse generator is connected to one or more probes comprising electrodes whose role is todistribute this energy to the core in a suitable way.
The present invention relates to the particular case where the generator is connected to a "mono-body" probe, that is a single probe carrying the various electrodes making it possible to deliver shocks of defibrillation or cardioversion. Theshock electrodes appear as windings of wire supported by a distal tubular extremity of the probe and are intended to come into contact with cardiac tissues at the place where the cardioversion or defibrillation energy must be applied. The windings areconnected to a conducting wire traversing the length of the probe.
Mono-body probes generally comprise two shock electrodes: a first electrode, known as "supraventricular," which will be positioned in the high vena cava to apply the shock to the atrium; and a second electrode, a ventricular one, which will belocated more closely to the distal extremity of the probe.
The mono-body probes are generally of the "isodiameter" type, i.e., they have the same diameter over the entire length of the distal part intended to be implanted in the venous network. This facilitates implantation, as well as any laterexplantation. This means that the external surface of the windings forming the shock electrodes is flush with the external surface of the probe, so as not to present any change in diameter along the implanted length of the probe.
The manufacturing of these mono-body probes is relatively delicate, taking into account the presence of the windings, the requirements for continuity of probe diameter, and the need for carrying the electric connection inside the body of theprobe with the electrical conductor allowing delivery of the shock energy.
The technique employed until now to manufacture these probes consists of taking a plurality of tubular sections of encasable sheath, one after another, setting up the windings, and electrically connecting them progressively to their internalconductor at the various sections of the tube of the probe. This structure, which makes it possible to answer the specific constraints associated with manufacturing these probes, has, however, the disadvantage of creating zones and/or electricweaknesses at the places where the various sections are connected, in particular short-circuits on the high voltage conductor supplying the shock energy. However, in practice, it has been noted that the ruptures of the insulated tube support often occurat the places of the connections between the various sections of sheath, because of the zones of weakness locally created at the place of these connections. Moreover, this structure of encased sections implies a relatively complex and long manufacturingprocess, in particular because of the need for sticking the successive sections together. U.S. Pat. No. 6,374,142 and PCT Application No. WO-A-02/087689 describe such mono-body isodiameter probes produced starting from encased successive sections ofsheath.
One of the goals of the present invention is to cure the above-described disadvantages by proposing another structure for the distal part of a mono-body defibrillation probe--a structure that does not present a zone of weakness in the vicinityof the windings and can be manufactured simply and quickly.
The probe of the invention is a mono-body defibrillation probe of the known type described above, i.e., with a probe body that includes at its distal extremity an insulated sheath core of a tubular flexible material, supporting at its peripheryat least one winding of wire forming a shock electrode for application of a defibrillation or cardioversion energy, this winding being electrically connected to an electrical conductor extending longitudinally in an internal lumen inside the sheath core.
Very advantageously, the sheath core locally comprises a crossing cavity located in the vicinity of at least one of the winding ends. It is envisaged moreover that an insert of conducting material, of a size homologous with the aforesaidcavity, is placed therein, with this insert being electrically connected, on the interior side, with the electrical conductor and, on the external side, with the corresponding extremity of the winding.
In particular, the sheath core can comprise a cavity in the vicinity of each extremity of the winding, and it then comprises also a crossing longitudinal slit connecting the two cavities and radially extending from the external surface of thesheath core to the internal lumen thereof, so as to allow, by elastic strain of the material of the sheath core on both sides of the slit, the introduction into the cavities and the internal lumen of the unit formed by the final extremity of theelectrical conductor provided beforehand with the two inserts to which it was mechanically and electrically connected.
In one embodiment of the invention, it is envisaged to have junction ring for mechanical and electric connection of the insert to the winding, this ring being a cylindrical ring of conducting material, with an internal surface able to cooperatewith a part turned towards the outside of the insert, and an external surface comprising a connection part able to cooperate with a part turned towards the interior of the extremity of the winding. This ring can in particular comprise, in the area ofinternal surface able to cooperate with the insert, an assembly part capable of allowing mechanical and electric solidarization from the ring to the insert. The assembly part is preferably a part comprising a crossing opening able to allowsolidarization of the ring to the insert by welding from the outside. Moreover, the diameter of the assembly part is greater than the diameter of the connection part, the difference of the diameters being approximately equal to double the thickness ofthe winding, so that the external surface of the ring is approximately level with the external surface of the winding.
Preferably, the probe is provided with an external envelope made of a flexible insulated material sheathing the sheath core along its length, except for the area of the winding, with the diameter of the external envelope being approximatelyequal to the diameter of winding. In this case, the ring can also comprise, at the opposite side of the connection part, a shafting part receiving the extremity of the external envelope adjacent to the winding. For the assembly, the insert cancomprise, on the interior side, a sleeve, axially oriented, for crimping the insert to the electrical wire. Preferably both the space included between the radial walls of the slit and the internal volume of the lumen in the area of the slit are providedwith an electrically insulated sealing material, such as polymeric resin that is hardenable, e.g., an adhesive silicone.
Further benefits, features, and characteristics of the present invention will become apparent to a person of ordinary skill in the art in view of the following detailed description of a preferred embodiment of the invention, made with referenceto the annexed drawings, in which like reference characters refer to like elements, and in which:
In FIG. 1, reference 10 indicates generally a mono-body probe of which the distal extremity 12 is intended to be introduced by the venous network into the two atrial and ventricular cavities, so as to detect there cardiac activity and apply asneeded a defibrillation or cardioversion shock. The probe is provided at its proximal extremity 14 with various elements for connection to an appropriate generator, e.g., a generator of the Defender or Alto or Ovatio type manufactured by the assigneehereof, ELA Medical, Montrouge, France.
Probe 10 carries a first shock electrode 16, intended to be placed in the right ventricle and constituting, e.g., the negative terminal for application of the potential voltage of defibrillation or cardioversion. This ventricular shockelectrode 16 is connected by a connection conductor 18 on a connection terminal 20 to the generator, advantageously a terminal of the DF-1 standard type.
Probe 10 also carries at its distal part 12 a second shock electrode 22, which is known as a "supra-ventricular" an electrode, intended to be positioned in the high vena cava for application of a shock to the atrium. This supra-ventricularshock electrode 22 is connected by connection conductor 24 on connection terminal 26 to the generator, preferably also with a DF-1 standard connector.
Probe 10 is also equipped with an extremity electrode 28, which is a detection/stimulation electrode intended to be positioned at the bottom of the right ventricular cavity. This electrode 28 is connected by a conductor 30 on a connectionterminal 32 to the pacemaker, advantageously with an IS-1 connector standard.
As shown in FIG. 4, conductor 30 is a hollow conductor, e.g., a conductor internally wound, having in its center a lumen 34 that allows introduction of a stylet for the guidance of distal extremity 12 by a physician into the venous network atthe time of implantation of the probe 10.
Referring again to FIG. 1, the defibrillation potential can be applied between the supra-ventricular shock electrode 22 and the generator case, or between the ventricular shock electrode 16 and the generator case, or between electrodes 16 and22, in a bipolar mode.
The configuration just described (i.e., two defibrillation electrodes and one stimulation electrode) is, however, not restrictive, and the invention is also applicable to the case of a probe equipped with only one defibrillation electrodewinding, or not including a distal stimulation electrode, or including two stimulation electrodes (for a stimulation in bipolar mode, in particular), etc.
FIGS. 2 and 4 more precisely show the configuration of three conductors 18, 24, and 30 in the distal tubular extremity 12 of the probe 10. These conductors are placed in respective lumens of a tubular sheath core 36 made out of a flexibleinsulated material such as a silicone. The conductors 18 and 24, which must transmit the defibrillation or cardioversion energy, are micro-cables having their own insulators, respectively 38 and 40, e.g., in ETFE. The silicone material constituting thesheath core 36 presents excellent properties of fatigue strength. Regardless, it would be difficult to make the sheath core 36 penetrate in the venous network just as it is, and for this reason the sheath core is wrapped outside by a sheath 42 made outof a material with low coefficient of friction, e.g., polyurethane.
The present invention relates more particularly to the way in which the probe 10 is constructed/assembled in the vicinity of the shock electrode windings 16 and 22. FIGS. 3 and 4 illustrate a preferred structure for the ventricular shockelectrode winding 16. Because this structure is the same supraventricular shock electrode winding 22, the structure for that winding will not be further described in detail.
In a way characteristic of the invention, the sheath core 36 is a solid tube, without solution of continuity over the entire length of the distal part 12, in particular in the area of the windings 16 and 22. This is due to a particularstructure of the electric connection system between the winding and its corresponding conductor located inside the sheath core 36.
Thus, as illustrated in FIGS. 3 and 4, conductor 18, intended to feed the winding 16, is equipped with two metal parts 46, 46' which function as inserts, solidarized mechanically, and electrically connected, with the conductor 18 by setting of(sliding) sleeves 48, 48' over a stripped length emerging from insulator 38.
It is indeed desirable to have an electric connection of conductor 18 with the two ends of winding 16, in order to produce the most homogeneous possible electric field between these two ends at the time of application of the defibrillation orcardioversion energy. If the winding is fed by its two ends, the current density will be better distributed, thus avoiding the risk of burning the surrounding tissues. For a defibrillation shock that can require application of energy of up to 40joules, the peak voltage can reach 750 V. For this voltage, the homogeneity of the electric field at the time of the shock is a significant constraint to take into account when designing the probe.
As illustrated in FIG. 3, the sheath core 36 comprises two cavities 50, 50', which extend from the external surface of the sheath core to the lumen 44 (FIG. 4) receiving conductor 18. These two cavities 50, 50' are joined together by alongitudinal slit 52 (FIG. 3), which extends along the sheath core 36 and radially from the external surface of the sheath core to the lumen 44 (FIG. 4) receiving conductor 18. The interior dimensions of these cavities 50, 50' are homologous with theexternal dimensions of inserts 46, 46', so that the inserts can be entirely placed into the cavities, with their upper surface 54 (FIG. 4) being level with the upper surface 56 of the sheath core 36. On the interior side, the lower face 58 of insert 46preferably rests on the surface 60 of the lumen 44.
The electric and mechanical connection of inserts 46, 46', and thus of conductor 18, with winding 16, is carried out via junction rings 62, 62'. The junction ring 62 presents a central part 64, from which interior surface 66 comes in contactwith the upper surface 54 of insert 46. The external surface 68 of the central part 64 has a diameter roughly equal to the external diameter of winding 16 and the external diameter of the polyurethane sheath 42; based on that, the external surface 70 ofthe sheath is level with the external surface 68 of the ring, thus ensuring the required isodiameter configuration. On the side that is farthest from the winding 16, ring 62 comprises a part of lesser diameter 72 intended to fix with force (frictionforce fit) in the interior extremity of the external sheath 42. On the side that is closest to the winding, the ring 62 comprises a part of lesser diameter 74 intended to fix with force in the interior extremity of winding 16.
To ensure the electric and mechanical solidarization of insert 46 to the connection ring of 62 (and thus winding 16), the central part 64 of the ring is equipped with an opening 76, making it possible to carry out from the outside welding point78 (like that illustrated on the right FIG. 4), preferably a laser welding point.
First of all, the sheath core 36 is prepared with its external sheath 42 only in the proximal area of the probe, i.e., on the left part of FIG. 4. This external sheath thus stops in the vicinity of cavity 50 on the proximal end of the probe 16,i.e., toward the left in FIGS. 3 and 4. Separately (e.g., on another preparation setup) insulator 38 of conductor 18 is stripped on its distal side over an adaptable length, to crimp there two contact blocks 46, 46' at a desired distance, by means ofsleeves 48, 48'. The unit obtained is illustrated partly on the top portion of FIG. 3. Conductor 18 is then threaded by its proximal extremity (i.e., the one opposed to the contact blocks 46, 46') into lumen 44 via opening 50 of the sheath core 36,while letting exceed on the distal side the free part with the inserts 46, 46'. The set formed by this length of wire with the inserts 46, 46' is then completely introduced inside the sheath core 36, by placing two inserts 46, 46' in the two homologouscavities 50, 50', with the part of conductor 18 connecting these two inserts being introduced by elastic deformation of sheath core material on both sides of slit 52. Once the unit is thus introduced, sleeves 48, 48' and conductor 18 find their placeinside lumen 44 and the two lips of slit 52 can thus regain their initial shape. The unit is maintained tightly in place with a local injection, via slit 52, of a resin silicone mass (reference number 80 on FIG. 4), which thus comes to fill lumen 44 atthe place of slit 52 and cavities 50, 50', with a tight obturation of lumen 44 on both sides of the unit thus made up.
The following stages consist of, successively: 1. slipping on the ring 62, 2. fixing the ring 62 in the part of external sheath 42 located on the proximal side of the probe (on the left on FIG. 4); 3. slipping on the winding 16; 4. fixingthe proximal extremity of the winding on the ring 62; 5. slipping on the ring 62; 6. fixing the ring 62 on the distal extremity of the winding 16; 7. slipping the sheath 42' on the distal side of the probe; and 8. fixing on the ring 62'.
The unit is thus mechanically assembled. The operation is repeated identically for the other winding. Laser welding points 78 make it possible to perform the electric and mechanical connection of the rings 62, 62' on the one hand to the endsof winding 16 (in zone 74), and on the other hand to the respective inserts 46, 46'.
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