Universal male connector for monopolar cardiac stimulation probe and method for its mounting.

p0001The present invention relates generally to cardiac pacemakers and more precisely the connecting means used between the cardiac lead and the stimulator.

p0002At present, virtually every manufacturer of pacemakers makes the connection between pacemakers and probes it manufactures by means of its own. This forces always replace a pacemaker by the same type of pacemaker.

p0003To enable the adaptation of any pacemaker to all sensors, professional circles are developing an international standard defining the male and female connectors which will in the near future be used on all models of implantable pacemakers.

p0004This raises the problem of achieving new pacemakers connection standards with an old probe already implanted in a patient. In fact, when changing a pacemaker to always benefit the patient the latest advances in technology, we rarely change the probe because it has a greater lifespan than the stimulator and more is often difficult to extract.

p0005It has been proposed extenders carrying at one end a standard male connector and at the other end a female connector fitting the male connector of the probe in place. These devices are bulky and therefore not easy to implement because a considerable length is necessarily provided between the two connectors to facilitate handling. In addition, the clinician must be in possession of as many extensions there are connection types on the market.

p0006It was also proposed adapters are wanting to be more universal but with other disadvantages. Some are not completely universal, others pose sealing or handling problems, some are no longer comply with the standard after binding with the driver. All these models are used after cutting the probe connector into place.

p0007The present invention therefore aims to provide a universal plug corresponding to standards that can be easily implemented at the end of any monopolar probe replacing the plug thereof, ensuring mechanical connection and reliable electric as well as a perfect seal.

p0008For this purpose the universal male connector to be mounted on the cut end of a cardiac probe formed by a sheath in which is positioned one or more son conductors wound spirally to form a standardized connector, characterized in that:<ul><li>it is formed by two parts joinable to one another,</li><li>the first part is formed of a rear sleeve in plastic material of corresponding outer dimensions than those defined by the standard to a non-conductive area, and having standardized sealing rings; inside the rear sleeve extends over at least a portion thereof, a proximal rigid ring, projecting from said rear side of the sleeve rings to create a standardized zone,</li><li>the second part is formed of an electrically conductive distal screw with a sleeve before plastic outer dimensions corresponding to those defined by the standard for a non-conductive region and having standardized sealing rings; the distal screw protruding from said front sleeve on the side of the rings under standard dimensions,</li><li>the rear sleeve and the proximal ring of the first part are penetrated by a bore in which is slidable the conductor of the lead,</li><li>means are provided to ensure an electrical connection between the conductor and the conductive distal plug.</li></ul>

p0009The connector is further characterized in that:<ul><li>the means are formed by an integral stylus of the second part, formed by a conductive part of outside diameter smaller than the inner diameter of the winding of the son or the driver, said stylet having the overall shape of a recumbent Z ending with of the axial portions, the distance separating the two radially external portions being greater than the diameter of the bore of the proximal ring;</li><li>the bore of the first part is formed by a portion in the rear sleeve and extends into the proximal ring; its diameter is greater than the maximum outer diameters of the existing conductors, it is connected by a conical portion to a larger diameter bore;</li><li>the bore is tapped whereas the end of the conductive distal plug bearing the stylus is threaded;</li><li>the rear sleeve is covered by a flexible elastic skirt during assembly intended to be glued on the outer face of the sheath;</li><li>the bore in the proximal ring can be annularly grooved;</li><li>the skirt has a constriction which compresses the sheath.</li></ul>

p0010The invention also relates to the method of mounting such a connector on a cardiac lead, characterized in that: <ul><li>you cut the tip of the probe so as to delete the old connector,</li><li>the the thread is gripped and pulling it so clearly exceed do the cladding;</li><li>one clip if necessary the duct to keep the thread on the outside,</li><li>one puts on the first connector part on the thread until it abuts against the end of the sheath, while the coiled conductor wire extends outside of the workpiece;</li><li>one grasps the second portion of the connector with the stylus in Z which are threaded into the spiral thread,</li><li>is introduced in the second part the first part and is secured by screwing the threaded portion of the plug into the internal thread of the ring.</li></ul>

p0011The method is further characterized in that:<ul><li>is coated adhesive sheath and as it is unrolled flexible sleeve to secure the back of the coated sleeve and thus ensure a perfect seal;</li><li>the screwing is carried out with a screwdriver tool the hex end is inserted into a complementarily shaped recess provided at the end of the plug.</li></ul>

p0012The invention will be better understood from the following description of an embodiment thereof with reference to the figures in which:

p0013Figure 1 shows the standardized male connector;

p0014Figures 2 to 9 show the adapter of the assembly stages according to the invention.

p0015We see in Figure 1 the male connector as recommended by the standard. This connector comprises two zones electrically conductive 11, 12 of different diameters in the case of a bipolar probe. One electrically conductive region 11 is useful in the case of a unipolar lead. Two areas 13, 14 having rings of larger diameter than the conductive areas, intended to be applied against the inner wall of the female connector provided on the pacemaker, are arranged to ensure the tightness of the connection and avoid the untimely slip on the male connector into the female connector.

p0016Two non-conductive areas 15, 16 are further provided one between the first region 13 having rings and the second zone 12 and the other to the rear of the connector side of the area 14. These areas 15, 16 are intended to seal with possible sealing rings may be provided within the female connector of the pacemaker.

p0017The standard defines the diameter and length of each zone of the connector; it also offers mechanical and electrical tests to ensure maximum sealing while minimizing connection efforts.

p0018We will now describe the connector of the invention together with its reference mounting type to Figures 2 to 9. Figure 2 shows the end of a cardiac probe 2 which has been cut in order to removing the non-standard connector she wore. Known manner, such a probe is formed by a sheath 20 of a plastic material compatible with implantation in the human body. Inside the sheath 20, the conductor wire 21 is formed of one or more wound strands in a very tight spiral which provides a flexible probe to be introduced into the various venous channels but not s' not overwhelming. The diameter of the strands and the winding diameter of the conductor 21 may vary from a sensor model to another. Similarly, the wall thickness of the sheath 20 may be variable from one model to another. After cutting the probe 2, the thread 21 is entered, if necessary after naked and pulling the outside of the sheath 20 as shown in Figure 3. The thread 21 is then maintained at the outside by pinching of the sheath 20 it tends to shrink.

p0019It then puts the first part 3 of the connector on the end of probe 2.

p0020This first part 3 of the connector is formed of a rear sleeve fixed elastic and insulating plastics material with a rigid proximal ring 32, which protrudes at one end. The proximal ring 32 is pushed axially inside the rear sleeve 30 on at least a portion of its length.

p0021The rear sleeve 30 is generally cylindrical and the diameter is recommended by the standards for Zone 16.

p0022At its end which exceeds the proximal ring 32, the sleeve 30 has rings 38 of dimensions and position within standard zone 14. The projecting portion of the part 32 meets for its geometry determined for the zone 12.

p0023The rear sleeve 30 also comprises a flexible and elastic skirt 31 which covers it.

p0024The proximal ring 32 is generally cylindrical; a shoulder 33 on its outer surface allows its positioning in the rear sleeve 30.

p0025The rear sleeve 30 and the proximal ring 32 have bores 35, 34 in extension of one another diameter larger than the maximum outer diameters of the existing conductors.

p0026The bore 34 of the part 32 is adjoined by a conical portion 37 in a bore 36 of larger diameter which finishes with a threaded portion at the free end of the part 32.

p0027This first part 3 of the connector is threaded onto the thread 21 so that the rear sleeve 30 is positioned against the sleeve 20, while the lead wire 21 protrudes from the free end of the proximal ring 32. Once the part 3 well positioned, we grabbed the second part 4 of the connector.

p0028screwdriver can for this purpose help of a tool 5 having an extension 51 of hexagonal cross-section adapted to be inserted into a recess 41 of complementary female shape of the second part 4 of the connector. the hexagonal end of the dimensions will advantageously be chosen to be identical to the dimensions commonly used for locking systems connectors stimulators.

p0029The second part 4 is formed of an electrically conductive distal plug 42 surrounded by a tubular front sleeve 43 of plastics material on a portion of its length.

p0030The portion of the workpiece 42 projecting from the sleeve of the side having the recess 41 meets the standardized dimensions for the conductive area 11 while the front sleeve 43 is of a size suitable to form the area 15 of the standard driver and has rings 46 in accordance with the zone 13.

p0031The part 42 is generally cylindrical with an outer diameter adapted to penetrate in the bore 36 of the first part 3 of the connector; This part 42 is threaded over a length adapted to cooperate with the internal thread of the bore 36.

p0032The part 42 has a shoulder 44 for positioning the front sleeve 43.

p0033The end of the second part 4 of the connector for engagement in the bore 36 of the first part 3, has a stylus 45.

p0034The stylet 45 is a conductive part of outside diameter smaller than the inner diameter of the winding of the conductive wire 21. This stylus 45 is generally in the form of a coated Z ending in axial portions. The distance separating the two radially outer portions is greater than the internal diameter of the bore 34 of the first part. This stylus can advantageously be terminated with a spherical end 47.

p0035As can be seen in Figures 4 and 5, is threaded said stylet 45 in the protruding end of the conductor 21, winding said conductor due to its flexibility marrying the external shape of the pen.

p00364 The second part of the adapter is gradually inserted into the bore 36 of Part 3.

p0037The driver 21 Z stiffened by the stylus 45 then comes into contact with its radially outer portions with the tapered portion 37 of the bore of the first part 3 which requires it to flatten and into the bore 34 smaller diameter.

p0038The stylus 45 is a conductive material having elasticity then stuck the driver 21 between itself and the bore of the part 32, the mistletoe provides electrical and mechanical connection between the driver 21 and the distal plug 42.

p0039For this purpose, the bore 36 may be annularly ribbed so as to increase the coefficient of friction and improve the mechanical strength of the conductor 21 in the connector.

p0040When the second part 4 is pressed, it is secured to the first part by cooperation of the thread of the part 42 with the internal thread of the part 32 as seen in Figures 6 and 7 until the shoulder provided on the part 42 abuts against the workpiece 32; the front sleeve 43 then presses against the part 32.

p0041The mechanical and electrical connection of the conductor 21 with the two parts 3, 4 of the connector being made, it ensures a mechanical connection and a perfect sealing of the assembly between the sheath 20 of the probe 2 and the connector by coating the sheath of glue 6 and drop down the skirt 31 which covers the coated portion of the sheath 20 and the throttle sheath 20 in the region 39 solidarisant and said sleeve 20 by clamping and gluing as shown in figures 7 and 8.

p0042Instead of a skirt 31 adhered on the sheath 20 of the probe for securing the probe and the connector can be provided to directly bond the sheath 20 in the connector 3. To this end, the sleeve 30 is provided to the rear over a part of its length, a sufficient bore for receiving the sheath 20. at the time of inserting the sheath 20 into the sleeve 30, an adhesive is injected to ensure their securing.

p0043It is seen in Figure 9 the end connector thus obtained, the latter shows the different zones 11, 12, 13, 14, 15, 16 defined by the standard, which are formed by the parts 30, 32, 42, 43.

p0044A universal connector according to the invention, and we will able to understand, simply and securely replace the connector of any monopolar probe with a standard connector when changing the pacemaker of a patient.