Abstract:
The invention relates to a device for handling at least one guide wire ( 51 ) in order to guide an invasive medical instrument or in order to handle a catheter shaft using invasive medical techniques. A fixing arm ( 13 ) which can be fixed to an introduction valve ( 1 ) and a clamping device ( 16 ) attached to the fixing arm ( 13 ) are provided, wherewith the relevant guide wire or the catheter shaft can be secured against movements in the longitudinal direction. This enables the introduction valves ( 1 ) to be operated with one hand, while the other hand can be used for the manipulation of the other invasive medical instruments as opposed to having to fix elements such as a guide wire or catheter shaft which cannot be moved in a longitudinal direction.

Description:
CROSSREFERENCES TO RELATED APPLICATIONS 
   This application is a continuation of copending international patent application PCT/DE00/02944 filed on Aug. 25, 2000 and designating the U.S., which claims priority of German patent application DE 199 48 409 filed on Oct. 7, 1999. 
   BACKGROUND OF THE INVENTION 
   The invention relates to a device for handling at least one guide wire in order to guide an invasive medical instrument or for handling a catheter shaft in invasive medical techniques. 
   Devices for handling guide wires are, for example, disclosed in U.S. Pat. No. 5,159,861, U.S. Pat. No. 5,427,118, U.S. Pat. No. 5,318,541, U.S. Pat. No. 4,716,757 or U.S. Pat. No. 5,443,078. 
   In current practice in invasive medical techniques, for example in invasive cardiology or invasive radiology, an introduction valve is used which, for example in invasive cardiology, is attached to a guide catheter which is inserted from the groin area, for example, as far as the pericardial region of the aorta. Depending on patient-specific requirements, at least one guide wire is inserted in a manner known per se through the introduction valve and into the guide catheter, which guide wire reaches with its distal end as far as the ends of the vessels to be treated, and at least one invasive medical instrument is also inserted, for example, in the case of invasive cardiology, a dilation catheter for treatment of stenoses. After the guide wire has been fitted in place, it must no longer be able to move in the longitudinal direction at any time during the intervention in order, on the one hand, to avoid injuries in the end area of the vessels and, on the other hand, to guarantee unimpeded access to the treatment area throughout the intervention. The operating physician achieves this by gripping the guide wire between two fingers and thus preventing its longitudinal displacement during manipulation of an invasive medical instrument, for example an inserted dilation catheter, with the introduction valve opened. 
   However, in invasive surgery, this procedure has been found to be relatively awkward and has proven problematic for the patient, especially in view of the fact that longitudinal displacement of the guide wire are sometimes unavoidable even with the greatest care being taken. 
   SUMMARY OF THE INVENTION 
   The object of the invention is to make available a device for handling at least one guide wire in order to guide an invasive medical instrument or for handling a catheter shaft in invasive medical techniques, said device making it easier for the physician performing the invasive procedure to manipulate the invasive instruments during an operation. 
   According to the invention, this object is achieved with a device for handling at least one guide wire in order to guide an invasive medical instrument or a catheter shaft in invasive medical techniques, with a fixing arm which can be secured on an introduction valve, and with a clamping device which is arranged on the fixing arm and with which the particular guide wire or catheter shaft can be secured against longitudinal displacement. 
   Providing a fixing arm, with a clamping device arranged on said fixing arm, for securing a guide wire or catheter shaft against longitudinal displacement means that, after inserting a guide wire or after fitting an invasive medical instrument to be at least temporarily fixed, for example a catheter, the physician who is performing the invasive procedure is no longer obliged, during the operation, to fix the guide wire or a catheter shaft assigned to the invasive medical instrument, and can instead devote his complete attention to other work, such as actuating the introduction valve with one hand and manipulating an invasive medical instrument with the other hand. In this way, the risks to a patient in invasive medical techniques are greatly reduced. 
   In a preferred embodiment of the device according to the invention, the fixing arm can be secured on the introduction valve in a releasable manner via a groove-and-tongue connection. In a further preferred embodiment of the device according to the invention, the fixing arm can be secured on the introduction valve in a releasable manner via a plug connection. In one configuration of the latter embodiment, an adapter piece is provided with which the fixing arm can be secured in a releasable manner on the introduction valve. In this way, a relatively simple arrangement of the fixing arm on the introduction valve is obtained. 
   In a further preferred embodiment, the fixing arm is connected rigidly to the introduction valve. In this embodiment, it is guaranteed that the fixing arm cannot under any circumstances detach itself from the introduction valve during the intervention. 
   To ensure easy fixing, it is expediently provided that the fixing arm protrudes beyond an introduction end of the introduction valve. In this way, the elements to be fixed are held in a relatively rectilinear manner and strong bending is avoided. 
   In the last-mentioned configuration, it is further expedient for the fixing arm to have a securing portion and a holding portion which is angled off in relation to the securing portion. In this way, the area adjacent to the introduction end of the introduction valve remains relatively easily accessible. 
   In order to be able to use a clamping device with a plurality of clamping units, it is expedient for the fixing arm to have a securing portion and a holding portion designed as a holding plate. 
   With a view to obtaining a configuration which is as compact as possible, it is expedient for the clamping device to have a clamping unit for fixing a guide wire. 
   If a plurality of elements are to be fixed, it is expedient for the clamping device to have at least two clamping units which are arranged laterally spaced apart from one another and are used for fixing two guide wires or one guide wire and a catheter shaft. In this connection, it is particularly advantageous if the clamping device has three or four clamping units which are arranged laterally spaced apart from one another and are used for fixing guide wires and/or catheter shafts. 
   In one embodiment, the clamping device has, as clamping unit, at least one elongate clamping rail which has a holder part with a base plate and two side cheeks and has a clamping body inserted into the holder part and designed with a longitudinally extending clamping slit. In this way, sufficiently high frictional forces are exerted in particular on a generally relatively smooth guide wire. 
   In one configuration of the last-mentioned embodiment, it is expedient, with a view to obtaining a mechanically simple construction, if the base plate and the side cheeks are connected rigidly to one another and at right angles to one another. 
   According to a further configuration, in particular where the elements to be fixed by clamping rails according to the last-mentioned embodiment have relatively thick cross sections, it is expedient for each of the side cheeks to be arranged pivotably on the base plate via a respective hinge, and for a locking device to be provided for fixing them with the clamping slit closed. 
   In an expedient embodiment of the locking device, said locking device has two snap-fit lugs which engage one behind the other in the closed position of the side cheeks. 
   In a further preferred embodiment of the locking device, said locking device has a tilting bracket which at one end is articulated on one side cheek and, in the closed position, engages over the other side cheek. 
   To increase the frictional forces in a clamping slit, it is expedient for the clamping slit to be undulating. 
   In embodiments for increasing the frictional forces in a clamping slit, it is further provided that the clamping body has slits which are oriented transversely or obliquely with respect to the clamping slit. 
   In a further configuration of a clamping device, said clamping device has at least one clamping sleeve arrangement with a clamping sleeve and a screw sleeve which are designed with grooves that can be aligned relative to one another and are intended to receive a guide wire or a catheter shaft, the cross section of the clamping sleeve decreasing at least in stages in a direction of rotation. 
   In this configuration, the frictional forces exerted on the inserted elements can be advantageously adjusted. 
   In a further configuration of a clamping device, said clamping device has a counterplate and a rotatably mounted pivot body which, in a first pivot position, is at a distance from the counterplate, and, in a second pivot position, bears in part on the counterplate. 
   In another embodiment in this respect, the pivot body has a circular cross section and is mounted eccentrically. 
   In a further embodiment in this respect, the pivot body has an elliptical cross section. In the embodiment with a pivot body having an elliptical cross section, the pivot body is mounted centrally. In a further embodiment with a pivot body having an elliptical cross section, the pivot body is mounted in the area of a focal point. 
   The configuration and related embodiments with a pivot body are distinguished by particularly reliable fixing on account of the utilization of the lever action. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Further expedient configurations of the invention are the subject of the dependent claims and of the following description of illustrative embodiments of the invention with reference to the figures in the drawing, where: 
       FIG. 1  shows a side view of an introduction valve with a fixing arm which is arranged thereon and on which a clamping rail is arranged, 
       FIG. 2  shows a side view of an introduction valve with a fixing arm which is arranged thereon and on which three clamping rails are arranged, 
       FIG. 3  shows a rear view of an introduction valve according to FIG.  1  and  FIG. 2 , 
       FIG. 4  shows a side view of an introduction valve according to FIG.  1  and  FIG. 2 , with the fixing arm removed, 
       FIGS. 5 and 6  show a plan view and an end view, respectively, of a clamping rail with clamping body according to FIG.  1  and  FIG. 2 , respectively, 
       FIGS. 7 and 8  show, each in a plan view, further configurations of clamping bodies for clamping rails according to FIG.  1  and  FIG. 2 , 
       FIG. 9  shows, in cross section, a configuration of a clamping rail with tiltable side cheeks, 
       FIG. 10  shows, in cross section, a further configuration of a clamping rail with tiltable side cheeks, 
       FIG. 11  shows a side view of an introduction valve with a fixing arm on which a clamping sleeve arrangement is fitted, 
       FIG. 12  shows, in cross section, the clamping sleeve arrangement according to  FIG. 11  in an insertion position, 
       FIGS. 13 and 14  show a cross section and a side view, respectively, of the clamping sleeve arrangement according to  FIG. 11 , in a fixing position, 
       FIGS. 15 and 16  show, in plan view, a pivot body arrangement in an insertion position and in a fixing position, respectively. 
   

   DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     FIG. 1  shows a side view of an introduction valve  1  which, because it is operated with one hand, is used particularly advantageously in conjunction with the invention and has an elongate valve body  2 . At an attachment end  3 , the valve body  2  is equipped with a screw sleeve  4  which can be screwed onto a guide catheter not shown in FIG.  1 . Arranged on the valve body  2  in the area of the attachment end  3  there is a flexible locking arm  5  which has a number of catches  6 . Moreover, in the area of an introduction end  7  remote from the attachment end  3 , there is a bearing piece  8  which is secured on the valve body  2  and on which a handle  9  is rotatably mounted. Arranged at the end of the handle  9  remote from the bearing piece  8  there is a locking tongue  10  which engages with the catches  6  when the handle  9  is in approximately parallel alignment with the valve body  2 . 
   The handle  9  is used to actuate a tongue  11  of metal or plastic which engages with a pressure piston  12  inserted into the valve body  2  at the introduction end  7 . In the introduction position of the handle  9  shown in  FIG. 1 , an introduction opening is freed through which it is possible to introduce, for example, a guide wire for invasive instruments used in the area of invasive medical techniques, for example invasive catheters such as dilation catheters in invasive cardiology or corresponding instruments in invasive radiology or drills or reamers, and, after placement of the guide catheter, the relevant invasive instrument itself. 
   Finally, a side tube opens into the valve body  2  at an acute angle approximately in the area of the bearing piece  8 , and a manometer can be attached to this side tube in a manner known per se in order to monitor the pressure conditions. 
   It will be understood that differently configured introduction valves, for example equipped with a rotary closure piece for closing the introduction end  7 , can also be used in connection with the invention. 
   In the illustrative embodiment according to  FIG. 1 , a fixing arm  13  is arranged on the valve body  2  of the introduction valve  1 , which fixing arm  13  has a securing portion  14  aligned with the longitudinal axis of the valve body  2  and connected to the valve body  2 , and also a holding portion  15  which is angled off in relation to the securing portion  14 . Arranged on the holding portion  15 , as clamping device for a guide wire, there is an elongate clamping rail  16  as clamping unit, with which the guide wire or a catheter shaft of an invasive instrument can be secured against longitudinal displacements. 
     FIG. 2  shows a side view of an introduction valve  1  according to  FIG. 1  with a fixing arm  13  on which three clamping rails  16  are arranged on a holding plate  17  adjoining the securing portion  14 . The three clamping rails  16  can be used, for example, to secure two guide wires and a guide portion of an invasive instrument, or a guide wire and guide portions of two invasive instruments, against longitudinal displacements. 
     FIG. 3  shows a rear view of the introduction end  7  of an introduction valve  1  according to FIG.  1  and  FIG. 2 , and also the fixing arm  13  according to FIG.  1 . It can be seen from  FIG. 3  that a plug-in rail  18  is formed on the valve body  2  and has a groove  19  tapering towards its opening. On the securing portion  14  of the fixing arm  13  there is a web  20  which has a shape complementing the cross section of the groove  19 . The introduction valve  1  and the fixing arm  13  can thus be connected releasably to one another in the manner of a groove-and-tongue connection. 
     FIG. 4  shows a side view of an introduction valve  1  according to FIG.  1  and  FIG. 2 , with the fixing arm  13  removed. It can be seen from  FIG. 4  that the plug-in rail  18  has a length which leads to the fixing arm  13  being mounted in a manner free from play. At the end directed away from the introduction end  7 , the groove  19  of the plug-in rail  18  is terminated by a closure wall  21  on which the web  20  of the support arm  13  strikes after substantially complete insertion into the groove  19 , so that inadvertent pushing through is prevented. 
   FIG.  5  and  FIG. 6  show, in a plan view and end view, respectively, a clamping rail  16  according to FIG.  1  and FIG.  2 . The clamping rail  16  has, as holder part, a base plate  22  which is formed through the holding portion  15  and the holding plate  17  of the fixing arm  13  and on which a first elongate side cheek  23  and a second elongate side cheek  24  are arranged at right angles thereto. Inserted between the side cheeks  23 ,  24  there is a clamping body  25  which is made of a relatively soft compressible material, for example silicone, with a high coefficient of static friction. A clamping slit  26  is incorporated in the clamping body  25 , approximately centrally in the longitudinal direction, into which clamping slit  26  a guide wire, for example, can be inserted. The clamping slit  26  in the clamping body  25  is advantageously of undulating configuration, as is shown in  FIG. 5 , in order to increase the frictional forces exerted on an inserted, relatively smooth and stiff guide wire. 
   It can be seen from  FIG. 6  that the clamping slit  26  advantageously ends at a distance from the base plate  22  in order to keep the clamping body  25  in a single piece for simpler handling. 
   It will be appreciated that, in modifications of the above, the clamping slit  26  can also be made continuous and the clamping body  25  can be made in two parts. 
   FIG.  7  and  FIG. 8  show, in plan view, further configurations of clamping bodies  25  for clamping rails  16  according to FIG.  1  and FIG.  2 . In the configuration according to  FIG. 7 , the clamping slit  26  is rectilinear in the longitudinal direction of the clamping rail  16 . To increase the frictional forces, a number of transverse slits  27  are incorporated in the clamping body  25  which are at right angles to the clamping slit  26  and which wedge fast when a tensile force is exerted on an inserted guide wire or catheter shaft. In the configuration according to  FIG. 8 , the clamping slit  26  is likewise rectilinear in the longitudinal direction of the clamping rail  16 , but, in contrast to the configuration according to  FIG. 7 , a number of oblique slits  28  are incorporated in the clamping body  25  and oriented obliquely with respect to the clamping slit  26 . The oblique slits  28  are arranged in two groups facing in mutually opposite directions in order to increase the frictional forces in both directions by wedging when tensile forces are exerted. 
     FIG. 9  shows, in cross section, a configuration of a clamping rail  16  which, like the clamping rails  16  shown in  FIG. 1  to FIG.  3  and  FIG. 5  to  FIG. 8 , has a base plate  22  and a clamping body  25  in which a clamping slit  26  is formed. The clamping rail  16  according to  FIG. 9  is designed with a tiltable first side cheek  29  and with a tiltable second side cheek  30  which are connected to the base plate  22  via a first hinge  31  and a second hinge  32 , respectively. In the configuration according to  FIG. 9 , the hinges  31 ,  32  are designed as webs which are relatively thin compared to the thickness of the tiltable side cheeks  29 ,  30  and which have sufficient elasticity for tilting of the side cheeks  29 ,  30  and a degree of safety against breaking which is sufficient for at least several dozen tilting maneuvers. 
   Arranged at the ends of the tiltable side cheeks  29 ,  30  directed away from the hinges  31 ,  32 , there is a locking device in the form of a snap-fit closure which is made up of a first snap-fit lug  33  and a second snap-fit lug  34  and in which, in the closed position, the snap-fit lugs  33 ,  34  engage one behind the other with substantially parallel alignment of the tiltable side cheeks  29 ,  30 . To open the tiltable side cheeks  29 ,  30 , the snap-fit closure can be opened by means of the snap-fit lugs  33 ,  34 , which each have a rounded thickened part at the end, being prized apart from one another by hand. 
     FIG. 10  shows, in cross section, a further configuration of a clamping rail  16  with tiltable side cheeks  29 ,  30  in accordance with the configuration according to  FIG. 9 , but with the locking device, in contrast to the configuration according to  FIG. 9 , being formed by a tilting bracket  35 . The tilting bracket  35  is connected via a bracket hinge  36 , designed as a web in the configuration according to  FIG. 10 , to that end of a tiltable side cheek  29 ,  30  which is directed away from the particular hinge  31 ,  32  and, at the end which is remote from the bracket hinge  36  it is angled off at a right angle and, to facilitate handling, is provided with an actuating button  37  in the area of the angled-off portion. To close the clamping slit  26 , the tiltable side cheeks  29 ,  30  are moved toward one another and, when they are in substantially parallel orientation to one another, the tilting bracket  35  is maneuvered so that the angled portion engages behind the side cheek  29 ,  30  lying opposite the bracket hinge  36 . 
     FIG. 11  shows, in a side view, an introduction valve  1  which is designed in accordance with the illustrative embodiments shown in  FIG. 1  to FIG.  4  and which has a fixing arm  13  on which a clamping sleeve arrangement  38  is arranged as the clamping unit of a clamping device. The clamping sleeve arrangement  38  has a clamping sleeve  39  which is connected in a rotationally fixed manner to the holding portion  15  of the fixing arm  13 , and a screw sleeve  40  which can be turned in relation to the clamp sleeve  39 . The clamping sleeve  39  has a clamping sleeve groove  41  which, in the insertion position shown in  FIG. 11 , is aligned with a screw sleeve groove  42  formed in the screw sleeve  40  so that for example a guide wire can be introduced into the clamping sleeve arrangement  38 . 
     FIG. 12  shows, in cross section, the clamping sleeve arrangement  38  according to  FIG. 11  in the insertion position. It will be seen from  FIG. 12  that the clamping sleeve  39  and the screw sleeve  40  are connected to one another in a rotatable manner via a thread  43 , the clamping sleeve  39  engaging partially in the screw sleeve  40 . At their ends pointing toward each other, the clamping sleeve  39  and the screw sleeve  40  are designed with mutually complementary bevels  44 ,  45  which, in the insertion position, are spaced apart from one another or lie against one another without any substantial deformation of the end of the clamping sleeve  39  engaging in the clamping screw  40 . 
   FIG.  13  and  FIG. 14  show, in cross section and side view, respectively, the clamping sleeve arrangement  38  according to  FIG. 11  in a fixing position in which the screw sleeve  40  is screwed onto the clamping sleeve  39  to such an extent that the bevels  44 ,  45  of the clamping sleeve  39  and of the screw sleeve  40 , respectively, come into engagement with one another and slide against one another, narrowing the clamping sleeve groove  41  in the end area. 
   It can be seen from  FIG. 14  that, in the fixing position, the clamping sleeve groove  41  and the screw sleeve groove  42 , not visible in the illustration according to  FIG. 14 , are twisted in relation to one another. 
   Thus, in the fixing position of the clamping sleeve arrangement  38 , a guide wire or catheter shaft which has been inserted into the clamping sleeve groove  41  and the screw sleeve groove  42  is secured against longitudinal displacement. To remove the guide wire or catheter shaft, the screw sleeve  40  must be turned relative to the clamping sleeve  39  until the clamping sleeve groove  41  is once again sufficiently opened and aligned with the screw sleeve groove  42 .  FIG. 15  shows, in a plan view, a pivot body arrangement  46  which can be connected to an introduction valve  1 , for example according to  FIG. 1  to  FIG. 4  (not shown in FIG.  15 ), in an insertion position. The pivot body arrangement  46  has a counterplate  47  which is connected to a fixing arm  13  (not shown in  FIG. 15 ) for securing on an introduction valve  1  or is made integral thereto. The pivot body arrangement  46  is also equipped with a compressible pivot body  48  which can pivot about an axis  49 . The axis  49  is arranged at a distance from the counterplate  47  greater than the smallest material thickness between the axis  49  and the outside of the pivot body  48 . To actuate the pivot body  48 , a lever  50  is provided which is connected to the pivot body  48 . 
   In the illustrative embodiment show in  FIG. 15 , the pivot body  48  is of elliptical design and the axis  49  is arranged eccentrically, for example in the area of a focal point. In the insertion position shown in  FIG. 15 , with appropriate alignment of the lever  50 , an interspace is present between the counterplate  47  and that side of the pivot body  48  facing toward the counterplate  47 , into which interspace a guide wire  51 , for example, can be inserted. 
     FIG. 16  shows the pivot body arrangement  46  according to  FIG. 15  in a fixing position in which the lever  50  has been moved and the pivot body  48  is pressed onto the counterplate  47  in order to secure the guide wire  51  against longitudinal displacement. In the fixing position shown in  FIG. 16 , the lever  50  can be fixed with locking means not shown in FIG.  16 .