Abstract:
An adapter for mechanically/electrically connecting an implantable electrode, via the proximal connector thereof including at least one connecting contact for the electrode, to at least one test terminal contact of a measuring device, includes an electrically insulating adapter housing, a connector receiving element adapted to connector shape, and at least one contact element disposed in the adapter housing establishing contact between the at least one connecting contact of the connector and the at least one test terminal. A receiving tray, having the receiving element for the connector, is mounted on the adapter housing and variable between open and closed contact positions. In the open position, the connector is inserted in the receiving element in a defined position and removed therefrom. In the contact position, the at least one connecting contact of the connector is brought in contact with the contact element in the adapter housing in a defined manner.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This patent application claims the benefit of co-pending U.S. Provisional Patent Application No. 61/660,838, filed on Jun. 18, 2012, which is hereby incorporated by reference in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to an adapter for mechanically and electrically connecting an implantable electrode, by means of the proximal connector thereof comprising at least one connecting contact for an electrode surface of the electrode, to at least one test terminal contact, in particular to an alligator clip, of a measuring device. 
       BACKGROUND 
       [0003]    With respect to the background of the present invention, reference is made that, for example, cardiac pacemakers, or so-called ICDs (intracardiac devices), comprise implantable stimulation electrodes for electrically connecting the stimulation device to a desired body tissue location. Implantable stimulation electrodes, for example, generally comprise measuring/pacing electrodes, shock electrodes, epicardial electrodes, endocardial electrodes, atrial or ventricular electrodes, unipolar or bipolar electrodes, and the like. 
         [0004]    Such stimulation electrodes comprise one or more electrode surfaces at the distal end of the electrode and a connector at the proximal end of the electrode. The latter is used as an interface to the implantable stimulation unit. 
         [0005]    When an implantable electrode is implanted in the patient, it is generally recommended to carry out several preliminary tests before permanently fixing the electrode in the final place thereof and before connecting the connector of the electrode to the implanted stimulation unit. For this purpose, the connector of the electrode is temporarily connected to a measuring device, for example, a patient system analysis unit, whereby a series of stimulation pulses of varying energy levels or other test signals can be supplied to the temporarily inserted electrode. 
         [0006]    This measuring device is connected to the connector of the electrode by way of test terminal contacts, for example, in the form of alligator clips. 
         [0007]    A problem with connecting such test terminal contacts to the connector of the electrode will be briefly highlighted hereafter based on the example of alligator clips. 
         [0008]    The direct clip-connection of the alligator clip to the connector is not very reliable in general terms because the alligator clips may detach from the connector during the test operation. Moreover, a poor contact connection may exist if the alligator clips are poorly positioned at the connecting contacts of the connector, and this poor connection can influence the tests and result in incorrect conclusions, for example, with respect to the positioning of the electrode. In addition, faulty contacting and short circuits may occur with careless use of such alligator clips. 
         [0009]    In connection with this problem, the prior art provides some solutions. For example, U.S. Pat. No. 7,777,140 discloses a type of contact clip, the clip jaws of which in each case accommodate the individual contact elements for the connecting contacts of the electrode connector. However, since the connector is inserted between the clip jaws, the connecting contacts of the electrode connector are not fully protected from contact. In addition, the connector may be incorrectly inserted in the contact clip, whereby the overall connecting safety of this known adapter solution is not adequate. 
         [0010]    Other adaptation solutions are shown in U.S. Pat. No. 5,354,326 and U.S. Pat. No. 7,753,696. All of these solutions have a common drawback that a precisely fit orientation of the test terminal contacts with the connecting contacts of the connector of the electrode is difficult. Especially with the adapter solutions shown in the aforementioned documents, often times a mandrin replacement, required by users of such electrodes, is not possible when the connector is in the inserted position in the adapter during the implantation procedure. 
         [0011]    The present invention is directed toward overcoming one or more of the above-identified problems. 
         [0012]    Starting from at least the problems of the prior art described above, it is an object of the present invention to create an adapter for mechanically and electrically connecting an implantable electrode to a measuring device, wherein the adapter allows simple and safe adapter handling and, more particularly, improved positioning of the connecting contacts of the electrode and the test terminal contacts of the measuring device with respect to each other. 
       SUMMARY 
       [0013]    At least this object is achieved by an adapter having the following features according to at least one of the independent claim(s):
       an adapter housing made of an electrically insulating material;   a receiving element for the connector which is adapted to the shape of the connector;   at least one contact element disposed in the adapter housing for establishing contact between the at least one connecting contact of the connector and the at least one test terminal;   a receiving tray, which is mounted on the adapter housing so as to be variable between an open position and a closed contact position, and in which the receiving element for the connector is disposed, wherein
           in the open position, the connector can be inserted in the receiving element in a defined position and be removed therefrom; and   by transferring the receiving tray into the contact position, the at least one connecting contact of the connector can be brought in contact with the contact element in the adapter housing in a defined manner.   
               
 
         [0020]    By inserting the connector in a receiving tray that is mounted in a defined manner in the adapter housing so as to be variable between the open and contact positions, the receiving tray serves as a positioning aid for the connector, which thus meets the requirement of being correctly brought in connection with the test terminal contacts in the contact position of the receiving tray. The receiving tray thus receives the connector in a correct position and feeds the connecting contacts thereof in a defined and precise manner to the contact elements disposed in the adapter housing, whereby safe electrical contact to the measuring device is established, for example, by way of alligator clips. Because the latter are not placed directly on the connecting contacts of the connector of the electrode, the electrode connector is effectively protected from damage, such as, for example, scratches or deformations. 
         [0021]    A variety of mounting designs are conceivable for the receiving tray on the adapter housing, however, two advantageous embodiments are preferred. For one, the receiving tray may be a drawer that can be displaced between the open and closed contact positions on the adapter housing, the displacement direction of the drawer then preferably extending transversely to the longitudinal direction of the connector. 
         [0022]    Secondly, the receiving tray may also be designed as a folding tray that can be pivoted between the two aforementioned positions, wherein the pivoting direction can then be again transversely to the longitudinal direction of the connector. 
         [0023]    The two aforementioned refinements are relatively easy to implement in terms of design. 
         [0024]    In a further preferred embodiment, the receiving tray can be fixed in the open and/or closed contact positions relative to the adapter housing by way of a latching engagement. Both positions preferably have latching engagements. Because of the detent function in the open position, controlled positioning and insertion of the connector in the adapter are possible. The latching engagement of the closed receiving tray in the contact position (i.e., the close position) prevents inadvertent opening and prevents the electrode from falling out of the adapter. 
         [0025]    The operating comfort and handling safety of the adapter according to the present invention can be further increased by designing the latching engagement to be detachable by way of a trigger button. The latter can be coupled to the adapter housing, for example, via a spring tongue that is integrally connected to both. The trigger button design can thus be easily implemented using mold features of the adapter housing that are easy to produce from an injection molding point of view. 
         [0026]    According to a further preferred embodiment, the connecting contacts of the connector can be completely covered toward the outside in the contact position of the receiving tray. This offers effective protection from contact when handling the electrode in conjunction with the adapter according to the present invention. 
         [0027]    Moreover, in front of the connector positioned in the receiving tray, the receiving tray and the adapter housing may be provided at their end faces with an opening to provide unobstructed access to a central electrode lumen guided through the connector, both in the open position and in the contact position. This refinement of the present invention allows simple replacement of a mandrin that is inserted in the central lumen of the electrode, without having to separate the adapter and connector. This advantage is absent in the types of contacting of the adapters shown in the aforementioned prior art. 
         [0028]    Further preferred embodiments relate to the contact element in the adapter housing, which may comprise an outwardly exposed contact surface for each test terminal contact. Preferably, a corresponding guide for the test terminal contact flanks each contact surface. For example, alligator clips can thus be safely placed on the adapter and be brought into electrical connection with the contact element thereof. 
         [0029]    In general, connectors of implantable electrodes comprise several connecting contacts. The adapter according to the present invention for such a connector may thus comprise two contact elements, which in each case are to be brought into connection with a connecting contact of the connector in the receiving tray and with a test terminal contact of a measuring device. 
         [0030]    To assure safe handling of the adapter and of the measuring device to be connected thereto, a polarity symbol may be associated with each of the exposed contact surfaces of the contact elements for the test terminal contacts. 
         [0031]    According to a further preferred embodiment, the adapter housing comprises two or four contact elements, for example, for use with pacing or defibrillator electrodes. Eight and more contact elements are also conceivable for other applications, as will be appreciated by one skilled in the art. 
         [0032]    Further features, aspects, objects, advantages, and possible applications of the present invention will become apparent from a study of the exemplary embodiments and examples described below, in combination with the figures, and the appended claims. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0033]    Further characteristics, details and advantages of the invention will be apparent hereafter from the description of exemplary embodiments based on the accompanying drawings. In the drawings: 
           [0034]      FIGS. 1-2  show perspective views, obliquely from above, of an adapter comprising a connector in the open and contact positions of the adapter drawer with the trigger button; 
           [0035]      FIGS. 3-4  show perspective views analogous to  FIGS. 1-2 , obliquely from below; 
           [0036]      FIG. 5  is a perspective view of the adapter according to  FIG. 2  comprising connected alligator clips and an inserted mandrin; 
           [0037]      FIGS. 6-7  show a perspective detailed view of a circuit board to be inserted in the adapter and a cut-away perspective view of the adapter, respectively; 
           [0038]      FIGS. 8-9  show perspective views, obliquely from above, of an adapter in a second embodiment comprising a connector in the open and contact positions of the adapter folding tray; 
           [0039]      FIGS. 10-11  are perspective views, obliquely from beneath, analogous to  FIGS. 8-9 ; 
           [0040]      FIG. 12  is a perspective view of the adapter according to  FIG. 9  comprising connected alligator clips and an inserted mandrin; 
           [0041]      FIGS. 13-14  show perspective views, obliquely from above, of an adapter in a further embodiment, without the trigger button, comprising a connector in the open and contact positions of the adapter drawer; and 
           [0042]      FIG. 15  is a perspective view of an adapter in a further embodiment, comprising four contact elements. 
       
    
    
     DETAILED DESCRIPTION 
       [0043]      FIGS. 1-7  show a first embodiment of an adapter  1  for mechanically and electrically connecting an implantable electrode  2 , which is shown in a cut-away view in the drawings, to a measuring device, which is not shown in detail, with the aid of test terminal contacts, as shown by way of example in  FIGS. 5 and 10  in the form of alligator clips  3 ,  4 . At the proximal end, which is apparent especially from  FIGS. 1 ,  8  and  13 , the electrode  2  comprises a connector  5 , which has four connecting contacts, three  6 . 1 ,  6 . 2 ,  6 . 3  in the form of annular surfaces on the connector body  7 , and a contact  6 . 4  on a pin  9  at the connector tip. The electrode  2  further comprises a central lumen  8 , which is guided out at the end of the electrode  2  via the pin  9  extending coaxially to the electrode  2 . 
         [0044]    The adapter housing  10  has a segmented outer shape, the rough contour of which can be described as being cuboid having a length L, width B and height H. It is made of an electrically insulating material, such as an injection molded plastic material, for example. 
         [0045]    A circuit board  11  comprising two contact elements  12 . 1 ,  12 . 2  in the form of metallic contact strips is inserted in the adapter housing  10 , wherein  FIGS. 1-4  and  6  show the exposed contact surfaces  13 . 1 ,  13 . 2  used to connect the alligator clips  3 ,  4 . In the connecting region to the connector  5 , spring contacts  14 . 1 ,  14 . 2 , which in each case are fixed to the circuit board  11 , are electrically connected to the contact elements  12 . 1 ,  12 . 2  and establish the contact with the connecting contacts  6 . 3  and  6 . 4  of the electrode  2  when the adapter  1  is closed (see  FIG. 6 ). The guides formed by the side walls  15  of the structure  16  on the adapter housing  10  and the protruding narrow sides  17  receive the “mouth”  18  of the alligator clips  3 ,  4  (see  FIGS. 5 and 12 ), wherein clamping safety is further increased by the ridges  24  at the lower face of the adapter housing  10 . 
         [0046]    A receiving element  19 , which in the exemplary embodiment shown in  FIGS. 1-7  is disposed in a drawer  20 , is provided for the connector  5  in the adapter  1 . This receiving element  19  corresponds to the shape of the connector  5 , whereby the connector  5  is received in the correct position and in a precisely defined manner in the drawer  20 , as is shown in  FIG. 1 . 
         [0047]    The position of the drawer  20  can be varied in the direction of the width B of the adapter housing  10  between the open position shown in  FIGS. 1 and 3  and the contact position shown in  FIGS. 2 ,  4  and  5  and, more specifically, it is mounted on the adapter housing  10  dispaceably by way of corresponding guides  21 . In the open position according to  FIGS. 1 and 3 , in which the connector  5  is inserted in the receiving element  19 , and in the contact position shown in  FIGS. 2 and 4 , the drawer  20  is latched relative to the adapter housing  10 . The latching engagement V is formed by a detent tongue  33 , which is configured on the drawer  20  and which, with a projection  34 , engages in a detent recess  35  in the adapter housing  10  in front of a trigger button  22 , which is apparent in  FIGS. 1 ,  2 ,  5  and  7  and by means of which an elastic spring tongue  23  is connected to the adapter housing  10  so as to be displaceable in the direction of the height H. The latching engagement V can be removed by the trigger button  22  by pressing the same, whereby the projection  34  is lifted out of the detent recess  35 . The drawer  20  is thus freely movable. 
         [0048]    From the open position shown in  FIGS. 1 and 3 , the drawer  20  is pushed with the inserted connector  5  transversely to the longitudinal direction A of the connector into the adapter housing  10 . In the contact position of the drawer  20 , shown in  FIGS. 2 ,  4  and  5 , the two connecting contacts  6 . 3  and  6 . 4  are electrically guided out via the spring contacts  14 . 1 ,  14 . 2  of the contact elements  12 . 1 ,  12 . 2 . By the latching engagement of the drawer  20  in this contact position, a safe connection is provided between the connector  5  and the contact elements  12 . 1 ,  12 . 2 . 
         [0049]    As shown in  FIG. 5 , a respective alligator clip  3 ,  4  is pushed thereon. The seat of the clip on the contact elements  12 . 1 ,  12 . 2  is further improved by ridge-shaped configurations  24  on the lower face of the adapter housing  10 , as shown in  FIGS. 3 and 4 . These ridges are intended to prevent the alligator clips  3 ,  4  from sliding off. Since the alligator clips  3 ,  4  are covered toward the outside, together with the contacts thereof, by insulating shoes  25 , in the overall a clean contact connection, which is protected from contact, is implemented between a measuring device and the connector  5  via the alligator clips  3 ,  4  and the adapter  1 . 
         [0050]    As is further shown in  FIG. 5 , the drawer  20  and the adapter housing  10  comprises an opening  26 , by way of which the pin  9  with the lumen  8  of the electrode  2  can also be accessed in an unobstructed manner in the contact position, shown in  FIGS. 2 ,  4  and  5 . The mandrin  27 , which is shown in  FIG. 5 , can thus be easily replaced by pulling it by the handle  28  thereof, or it can be actuated in another manner, without requiring any change to the positioning of the connector and adapter  1 . 
         [0051]      FIGS. 8-12  show a second embodiment of the adapter  1 ′. This differs from the embodiment according to  FIGS. 1-7  in the design of the receiving tray. This tray is implemented by a folding tray  29 , which is mounted on the adapter housing  10  pivotably about a pivot axis S extending parallel to the length. In the open position shown in  FIGS. 8 and 10 , the folding tray  29  is folded up, whereby the receiving element  19  is accessible laterally for the connector  5  of the electrode  2  (see  FIGS. 8 and 10 ). 
         [0052]    The connector  5  inserted in the receiving element  19  is pushed into the adapter housing  10  by the pivoting motion about the pivot axis S and is internally connected there mechanically and electrically to the contact elements  12 . 1 ,  12 . 2 . The latter are designed analogous to the exemplary embodiment of  FIGS. 1 to 7  and, thus, do not require explanation again. All of the components of the adapter  1 ′ which correspond with those of the adapter  1  according to  FIGS. 1-7  are denoted by identical reference numerals, whereby reference can be made to the description according to  FIGS. 1-7 . It shall be added that the folding tray  29  can likewise be latched in the open and contact positions according to  FIGS. 8 and 10 , and also  FIGS. 9 ,  11  and  12 . The latching engagement is achieved by simple pressing or pulling on the folding tray  29 . A trigger button is not provided here. 
         [0053]    It is important to mention that—as shown in FIG.  12 —the adapter  1 ′ is also designed to allow, via an opening  26 , a mandrin  27  to be suitably maneuvered via the handle  28  thereof during the connection of a measuring device by the alligator clips  3 ,  4 . 
         [0054]      FIGS. 13-14  show a further embodiment of an adapter  1 ″, which corresponds to the embodiment according to  FIGS. 1-7 . The only difference is that the trigger button  22  for removing the latching engagement of the drawer  20  in the open and contact positions has been omitted. Analogous to the exemplary embodiment according to  FIGS. 8-12 , these latching engagements can be overcome by simply pulling or pressing on the drawer  20 . 
         [0055]      FIG. 15  finally shows an adapter  1 ′″, which in the basic design corresponds to the adapter  1  according to  FIGS. 1-7 , however, it is designed to contact all four connecting contacts  6 . 1  to  6 . 4  of the connector  5 . Components that correspond with those of the adapter  1  have been provided with identical reference numerals and do not require explanation again. In contrast to the aforementioned exemplary embodiment, the variant of the adapter  1 ′ according to  FIG. 15 , however, shows four contact elements  12 . 1  to  12 . 4  on the circuit board  11 , with correspondingly exposed contact surfaces  13 . 1  to  13 . 4 , at which respective alligator clips can be placed. Analogous to  FIG. 6 , in the interior of the adapter housing  10 , the contact elements  12 . 1  to  12 . 4  on the circuit board  11  are connected to spring contacts, which can be brought in electrical connection with the individual connecting contacts  6 . 1  to  6 . 4  in the closed position of the adapter  1 ′ shown in  FIG. 15 . 
         [0056]    Finally, all four exemplary embodiments of the adapter  1 ,  1 ′,  1 ″,  1 ′ have in common that the adapter housing  10  is provided with polarity symbols  30  and  31  of “+” and “−”, respectively, which are associated with the respective contact surfaces  13 . 1 ,  13 . 2 . The polarity symbols  30 ,  31  are designed in a raised manner on the upper face  32  of the structure  16  of the adapter housing  10 . 
         [0057]    It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range.