Abstract:
An elongated guide sheath for delivering at least one medical instrument to a body lumen. For reliable and cost effective implantation of an electrode at the AV septum the inventive guide sheath forms a first guiding sleeve and a second guiding sleeve at least partly separated by a shared wall section, wherein the longitudinal axis of the first guiding sleeve and the longitudinal axis of the second guiding sleeve run parallel to a longitudinal guide sheath axis, wherein the wall of the first guiding sleeve and/or of the second guiding sleeve each comprises a slit which runs along at least part of the length of the respective guiding sleeve. Further, a system including the above guide sheath, a first catheter and/or guide wire and a second catheter or electrode is proposed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is the U.S. national phase under 35 U.S.C. §371 of PCT International Patent Application No. PCT/EP2015/061049, filed on May 20, 2015, which claims the benefit of German Patent Application No. DE 10 2014 108 475.6, filed Jun. 17, 2014, the disclosures of which are hereby incorporated by reference herein in their entireties. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to an elongated guide sheath for delivering at least one medical instrument to a body lumen. 
       BACKGROUND OF THE INVENTION 
       [0003]    Minimally invasive procedures have been implemented in a variety of medical settings, e.g., for vascular interventions, such as angioplasty, stenting, embolic protection, electrical heart stimulation, heart mapping and visualization, and the like. These procedures generally rely on accurately navigating and placing instruments within a patient&#39;s vasculature. During such procedures, guide wires are used to advance catheters, sheaths or similar medical devices into a patient&#39;s body vessel. 
         [0004]    Document U.S. Pat. No. 7,570,981 B2 discloses a complex guiding catheter system for accessing a patient&#39;s heart. 
         [0005]    In order to stimulate the right atrium and the left ventricle of the human heart the Atrioventricular Septum (AV septum) of the heart can be used. Such a dual chamber stimulation is nowadays very common and corresponds to a greater extend to the physiological behaviour of the human heart than other stimulation methods. For such a stimulation usually an electrode is used which comprises an elongated helix construction at its distal end which needs to be exactly positioned at the AV septum. 
         [0006]    It is possible to observe the movement of the electrode during implantation and to place the electrode exactly at the AV septum using an ultrasonic system for localization of the electrode tip. However, such an ultrasonic monitoring needs (beside the implantation of the electrode) another intervention which is usually started at the groin. However, this second intervention causes extra stress for the patient and requires another physician during the surgery. This is therefore an expensive, complicated method which does not conform to standard methods in this medical area. 
         [0007]    The present invention is directed toward overcoming one or more of the above-mentioned problems. 
       SUMMARY OF THE INVENTION 
       [0008]    Therefore, it is an object of the present invention to provide a system which is able to locate the AV septum easily and cost effectively. 
         [0009]    At least the above problem is solved by an elongated guide sheath for delivering at least one medical instrument to a body lumen, wherein the sheath forms a preferably cylindrical and elongated first guiding sleeve and a preferably cylindrical and elongated second guiding sleeve at least partly separated by a shared wall section, wherein the longitudinal axis of the first guiding sleeve and the longitudinal axis of the second guiding sleeve run parallel to a longitudinal guide sheath axis, wherein the wall of the first guiding sleeve and/or of the second guiding sleeve comprises a slit which runs along at least part of the length of the respective guiding sleeve. 
         [0010]    The inventive elongated guide sheath is of advantage because it is possible according to the present invention to first introduce a first catheter or a guide wire, preferably comprising a retaining element, and to temporarily fix the catheter or guide wire at the sinus coronarius for orientation, preferably using an inflated balloon. Then, the elongated guide sheath is inserted along the fixed first catheter or guide wire, wherein the first catheter or guide wire is accommodated within the first guiding sleeve. After that along the second guiding sleeve of the guide sheath a second catheter comprising the electrode for stimulation of the AV septum or a respective electrode is inserted and implanted at the AV septum using the catheter or guide wire fixed within the sinus coronarius as orientation. Thereby, an easy and cost effective implantation of an electrode at the AV septum is provided. No more additional ultrasonic monitoring is necessary. Accordingly, a second intervention for ultrasonic monitoring is avoided. 
         [0011]    The inner diameter of the first guiding sleeve and/or the second guiding sleeve of the inventive guide sheath is preferably between 0.3 mm and 5 mm, more preferred between 0.5 mm and 3 mm. The wall thickness of the first guiding sleeve and the second guiding sleeve is preferably between 0.1 mm and 0.5 mm, more preferred between 0.2 mm and 0.3 mm. 
         [0012]    The slit within the wall of the first guiding sleeve and/or of the second guiding sleeve is through going and allows accommodation of the first catheter and/or the second catheter and/or the guide wire within the guide sheath and/or easy removal. Further, the first guiding sleeve and the second guiding sleeve are accommodated beside each other. 
         [0013]    In a preferred embodiment the slit in the wall of at least the first guiding sleeve and/or the second guiding sleeve extends over the entire length of the respective guiding sleeve which simplifies the step of clipping the sheath on the first catheter or guide wire and further eases removal of the guide sheath after implantation of the electrode. 
         [0014]    It is further advantageous because of the same reason if the slit of the first guiding sleeve and/or the slit of the second guiding sleeve run at least sectionally parallel to the longitudinal guide sheath axis. In a further embodiment the slit of the second guiding sleeve is accommodated opposite to the slit of the first guiding sleeve in the respective outer wall. 
         [0015]    In a preferred embodiment at its proximal end the guide sheath comprises a handle for rotation of the sheath around the longitudinal sheath axis or parallel thereto. This handle further facilitates implantation of the electrode at the AV septum. 
         [0016]    A further embodiment of the inventive guide sheath comprises a tip at its distal end, preferably mainly formed by the shared wall section. This tip allows easier introduction of the longitudinal sheath into the vasculature. In a preferred embodiment, the walls of the first guiding sleeve and the second guiding sleeve are beveled at their distal end forming the tip. 
         [0017]    It is further of advantage if the shared wall section separates the first guiding sleeve and the second guiding sleeve completely in order to reduce interaction between a guide wire or a to first catheter accommodated within the first guiding sleeve and a second catheter or electrode accommodated in the second guiding sleeve. 
         [0018]    In order to monitor the position of the guide sheath the inventive guide sheath preferably comprises at its distal end, for example within or at the wall of the first guiding sleeve is and/or the second guiding sleeve, an X-ray visible element (marker) or magnetic element (marker). Preferably, the X-ray visible element has the form of a stripe. The X-ray visible element absorbs a larger amount of the impinging X-rays than the vicinity of this element within the human body during surgery and is therefore visible. 
         [0019]    As indicated above in a preferred embodiment the first guiding sleeve is adapted to receive a first catheter and/or a guide wire, each preferably comprising a retaining element, for example an inflatable balloon or a clamp. 
         [0020]    In a further preferred embodiment, the second guiding sleeve is adapted to receive a second catheter, preferably with an electrode, or an electrode. 
         [0021]    At least the above problem is further solved with the same advantages by a system comprising an elongated guide sheath as described above, a first catheter and/or guide wire, each preferably comprising a retaining element, and a second catheter, preferably comprising an electrode, or an electrode. 
         [0022]    Each of the above mentioned first and second catheters preferably comprises a catheter shaft and a connecting element for connection with the catheter control. The second catheter preferably accommodates at least one electrode with a respective connecting lead within its shaft. The first catheter preferably comprises a balloon at its distal end as the retaining element wherein the balloon may be inflated and deflated using a fluid supply accommodated within the catheter. 
         [0023]    In order to remove the second catheter without removing or loosening the implanted electrode at the AV septum the system further preferably comprises a slitter. 
         [0024]    A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art is set forth in the following specification of the preferred embodiments. Thereby, further features and advantages are presented that are part of the present invention independently of the features mentioned in the dependent is claims. 
         [0025]    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. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    The specification refers to the accompanying Figures showing schematically: 
           [0027]      FIG. 1  a first embodiment of an inventive system comprising a first and a second catheter and a first embodiment of an inventive guide sheath in a side view, 
           [0028]      FIG. 2  a distal end section of the inventive guide sheath according to the embodiment of  FIG. 1  in a side view, 
           [0029]      FIG. 3  a first catheter representing a first step of a surgical method for implantation of an electrode in the AV septum in a side view, 
           [0030]      FIGS. 4 and 4   a  the first catheter and the inventive guide sheath according to the embodiment of  FIG. 1  representing a second step of the surgical method in a side view and in a perspective view with the guide sheath partially introduced into a patient&#39;s body, 
           [0031]      FIG. 5  a first detail of  FIG. 4  showing a proximal portion of the first catheter and a proximal end section of the inventive guide sheath according to the embodiment of  FIG. 1 , 
           [0032]      FIG. 6  a second detail of  FIG. 4  depicting the distal end section of the inventive guide sheath according to the embodiment of  FIG. 1  and a distal portion of the first catheter, 
           [0033]      FIG. 7  a proximal portion of the first catheter, the proximal end section of the inventive guide sheath according to the embodiment of  FIG. 1  and a proximal portion of a second catheter representing a third step of the surgical method in a side view, 
           [0034]      FIG. 8  the distal end portion of the first catheter, the distal end section of the inventive guide sheath according to the embodiment of  FIG. 1  and a distal end portion of the second catheter representing the third step of the surgical method (also shown in  FIG. 7 ) in a side view, 
           [0035]      FIG. 9  a cross section of the human heart showing the arrangement of the distal end of the first and of the second catheter as well as of the inventive guide sheath, 
           [0036]      FIG. 10  the system of  FIG. 7  with removed inventive guide sheath in a side view, 
           [0037]      FIG. 11  the proximal end portion of the second catheter in further step of the method with a slitter in a side view, 
           [0038]      FIG. 12  a second embodiment of an inventive system comprising a first and a second catheter, a slitter and a second embodiment of an inventive guide sheath in a side view, 
           [0039]      FIG. 13  the inventive guide sheath according to the embodiment of  FIG. 12  in a cross section along the line A-A (see  FIG. 12 ), 
           [0040]      FIG. 14  a third embodiment of an inventive system comprising a second catheter, a slitter and a third embodiment of an inventive guide sheath in a side view, and 
           [0041]      FIG. 15  the cross section of the inventive guide sheath according to  FIG. 14  along the line B-B (see  FIG. 14 ). 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0042]    In  FIGS. 1 to 11 , a first embodiment of an inventive system with a first embodiment of an elongated guide sheath  10  is shown. Further, the treatment of the patient using this system is described in the following. 
         [0043]    The first embodiment of the inventive guide sheath  10  comprises an elongated body with a first cylindrical guiding sleeve  11  and a second cylindrical guiding sleeve  12 . Each guiding sleeve  11 ,  12  has for example an inner diameter of about 1.83 mm and a wall thickness of about 0.24 mm. Hence, a 5 F (French) catheter may be accommodated by each sleeve  11 ,  12 . The first guiding sleeve  11  and the second guiding sleeve  12  are accommodated in parallel beside each other such that the longitudinal sheath axis  14  runs parallel to the longitudinal axis (not shown) of the first guiding sleeve  11  and the longitudinal axis (not shown) of the second guiding sleeve  12 . As best seen in  FIG. 5  the first guiding sleeve  11  and the second guiding sleeve  12  are completely separated but connected by a shared wall section  16  which preferably runs along the entire length of the guide sheath  10 . Within its side wall the first guiding sleeve  11  comprises a through going first slit  17  which runs along the whole length of the guide sheath  10  and thereby of the first guiding sheath  11 . Analogously, the second guiding sleeve  12  comprises a through going second slit  18  in its side wall opposite to the first slit  17  wherein the slit  18  runs parallel to the longitudinal sheath axis  14  preferably along the whole length of the sheath  10  or the second guiding sleeve  12 . At the outer surface of the wall or within the wall of the second guiding sleeve  12  the guide sheath  10  comprises an X-ray visible element  19  which has the form of an elongated stripe. The X-ray visible element  19  may be realized by a single stripe or a plurality of stripes or patches. 
         [0044]    At the distal end of the inventive guide sheath  10  as best shown in  FIG. 2  the beveled walls of the first guiding sleeve  11  and the second guiding sleeve  12  form a tip  20 . The distal end of the tip  20  is formed by the shared wall  16 . 
         [0045]    is The guide sheath  10  further comprises at its proximal end a handle  21  that is fixed at the outer surface of the second guiding sleeve  12  for example (see  FIGS. 4, 4   a ,  5  and  7 ). 
         [0046]    Now, the method for implantation of an electrode at the AV septum using the inventive guide sheath  10  and the inventive system of  FIG. 1 , respectively, will be described referring to  FIGS. 3 to 11 . In these Figures the patient&#39;s body  5  is only shown in  FIG. 4 a    and in  FIG. 9 , where a cross section of the patient&#39;s heart  50  is depicted. 
         [0047]    In a first step the first catheter  30  shown in  FIG. 3  is inserted into the vasculature of the patient according to the usual procedure and is advanced such that the distal end of the first catheter  30  is located at the sinus coronarius  51  and temporarily fixed therein, for example by inflating a balloon  31  accommodated at the distal end of the first catheter  30  (perfusion). Therefore, preferably a balloon catheter is used. Alternatively, a locking guide wire or a normal guide wire may be used comprising a retaining element at its distal end. The location of the distal end of the first catheter  30  within the heart  50  at the end of the first method step is shown in  FIG. 9 . 
         [0048]    In the second step, at the proximal end of the first catheter  30  which projects from the patient&#39;s body  5  (ref.  FIG. 4 a   ) the inventive guide sheath  10  is clipped around the first catheter  30  using the first slit  17  such that the first catheter  30  is accommodated within the first guiding sleeve  11  (see  FIGS. 5, 6 ). Using the first catheter  30  as a guide the guide sheath  10  is inserted into the vasculature and advanced until a predetermined position is reached within the heart  50  and with regard to the position of the first catheter  30  (see  FIG. 9 ). The correct position of the distal end of the guide sheath  10  can be determined using the X-ray visible element  19 . 
         [0049]    Then, a second catheter  40  containing an electrode  41  with its connecting lead or alternatively an electrode is inserted within the second guiding sleeve  12  of the inventive guide sheath  10  (see  FIGS. 7 and 8 ) and advanced within the guide sheath  10  until the interior of the heart  50  is reached. Now or prior to insertion of the electrode the guide sheath  10  is rotated around the guide sheath axis  14  or parallel thereto using the handle  21 . After that, the electrode  41  at the distal end of the second catheter  40  is properly positioned at the AV septum  53  (see  FIG. 9 ) and implanted, i.e. fixed, there. 
         [0050]    Now, the guide sheath  10  is unclipped from the first catheter  30  and second catheter  40  by means of the first slit  18  and the second slit  19  and removed from the vasculature of the patient. Then, the first catheter  30  is removed after the temporary fixation of the first catheter within the sinus coronaries  51  is released, for example by deflation of the balloon  31 . This step is shown in  FIG. 10 . 
         [0051]    Then, the shaft of the second catheter  40  is removed from the patient&#39;s body using a slitter  55  (see  FIG. 11 ), wherein the electrode  41  stays fixed at the AV septum  53 . 
         [0052]    As the skilled person derives from the above explanation the inventive guide sheath  10  allows an easy and cost effective as well as exact location and implantation of an electrode at the AV septum  53 . An additional ultrasonic monitoring system is not necessary. 
         [0053]      FIG. 12  shows a second embodiment of an inventive system with a first catheter  30 , a second catheter  40 , a slitter  55  and a second embodiment of a guide sheath  60 . The guide sheath  60  comprises a first guiding sleeve  61  with a slit  17  and a second guiding sleeve  62  which are not fully separated as in the first embodiment of the guide sheath  10 . Accordingly, the separating wall section  66  of the first guiding sleeve  61  and the second guiding sleeve  62  contains a clearance  67  forming an elongated slit. The second guiding sleeve  62  does not have any slit in its wall. The slit  17  is used for clipping the guide sheath  60  around the first catheter  30  which distal tip is already positioned within the heart as described above. Removal of the second catheter  40  is facilitated by the slitter  55 . 
         [0054]    The first guiding sleeve  61  has an inner diameter d 61  of about 2 mm and the second to guiding sleeve  62  an inner diameter d 62  of about 3 mm. The wall thickness w 60  of the guide sheath  60  is about 0.1 mm. The height h 60  of the guide sheath  60  is about 15 F. 
         [0055]      FIG. 14  shows a third embodiment of an inventive system with a second catheter  40 , a slitter  55  and a third embodiment of a guide sheath  70 . 
         [0056]    As it can be seen in the cross section depicted in  FIG. 15  the guide sheath  70  comprises a first guiding sleeve  71  and a second guiding sleeve  72 , wherein the diameter d 71  of the first guiding sleeve  71  is much less than the diameter d 72  of the second guiding sleeve  72 . As examples d 71  is about 0.5 mm and d 72  is about 3 mm. The first guiding sleeve  71  serves for accommodation of a guide wire  75  rather than a catheter as in the previous embodiments of guide sheaths  10 ,  60 . The wall thickness of the first guiding sleeve  71  and the second guiding sleeve  72  w 70  is about 0.1 mm. 
         [0057]    Analogous to the embodiment of  FIGS. 12 and 13  the first guiding sleeve  71  and the second guiding sleeve  72  are not fully separated. The wall section  76  of the first guiding sleeve  71  and the second guiding sleeve  72  forms an elongated clearance in the form of a slit  77  therein with a width c 70  of about 0.38 mm. 
         [0058]    As depicted in  FIG. 15 , the second guiding sleeve  72  comprises a slit  18  for clipping the guide sheath  70  around the guide wire  75  that is correctly positioned within the patient&#39;s heart  50  comparable to the first catheter  30  described with regard to the previous embodiments above. The guide wire  75  is placed within the first guiding sleeve  71  and therefore passes clearance  77 . The catheter  40  is then introduced by the known Over-The-Wire Technique (OTW). After positioning of the electrode  41  within the AV septum the catheter  40  is removed using the slitter  55 . 
         [0059]    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. 
       REFERENCE NUMBERS 
       [0000]    
       
           5  patient&#39;s body 
           10  guide sheath 
           11  first guiding sleeve 
           12  second guiding sleeve 
           14  longitudinal axis 
           16  wall section 
           17  first slit 
           18  second slit 
           19  X-ray visible element 
           20  tip 
           21  handle 
           30  first catheter 
           31  balloon 
           40  second catheter 
           41  electrode 
           50  patient&#39;s heart 
           51  sinus coronarius 
           53  AV septum 
           55  slitter 
           60 ,  70  guide sheath 
           61 ,  71  first guiding sleeve 
           62 ,  72  second guiding sleeve 
           66 ,  76  wall section 
           67 ,  77  clearance 
           75  guide wire 
         c 70  width of clearance  77   
         d 61 , d 62 , d 71 , d 72  inner diameter 
         h 60 , h 70  height 
         w 60 , w 70  wall thickness