Abstract:
A proctoscope which comprises a body preferably in the form of a hollow cylinder which makes it possible to insert it in the anal canal of a patient. The body of the proctoscope is provided with a construction as a level of the part of a distal end and with an aperture and a handhold on the other end. The body of the proctoscope is also provided with a passage in order to form a surgical window oriented towards the internal free zone thereof. The surgical window is formed in the external wall of the body in such a way that it can enter the part of the distal end by contracting itself.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates to a proctoscope for the diagnostic and therapeutic treatment of hemorrhoids.  
         [0002]     It is estimated that in Western industrial countries, based on 100,000 people, approximately 1000 doctors&#39; appointments are required each year in order to diagnose and treat problems of the hemorrhoidal arteries. Depending on the severity of these problems (the medical literature has divided hemorrhoidal disorders into four different stages), various treatment methods exist for treating the individual stages. It is customary, in particular for the advanced stages of two or above, for the patients to be treated under anesthetic, sometimes in conjunction with several days&#39; stay in hospital.  
         [0003]     Since about the middle of the 1990s, a less invasive method which is potentially also suitable for the out-patient treatment of hemorrhoidal disorders has become known, originating in Japan—the so-called H.A.L. method (Hemorrhoidal Artery Ligation). In this H.A.L. method, a special proctoscope is inserted into a patient&#39;s anus and the hemorrhoidal arteries are detected by means of ultrasound Doppler sonography, which makes it possible to place the proctoscope with respect to the hemorrhoid. Through an operation window of the proctoscope, the operator can then suture and ligate the relevant vessels.  
         [0004]     This leads to a reduction in the blood supply to the hemorrhoids, the pressure in the vessels decreases, and after a short time the hemorrhoids shrink. This known intervention is advantageous in that it is normally carried out as an out-patient procedure and without any anesthesia, and has an extremely high success rate.  
         [0005]     Proctoscopes of the generic type, as required for carrying out the H.A.L. method, are sold in Germany for example by the company AMI. These proctoscopes allow the operator to make a reliable diagnosis visually and/or by means of Doppler sonography, and the operation window makes it possible to carry out the necessary operative steps to treat the hemorrhoidal problem.  
         [0006]     In such generic devices, however, the operation window is formed in a side wall or casing portion of the cylindrical proctoscope body. When the device is inserted into a patient&#39;s anus, this then leads to the serious disadvantage that the artery which (depending on the stage) is already inflamed or wounded rubs over the (sharp) edge of the operation window formed as a cut-out in the hollow cylinder, and further adjustment or positioning movements of the proctoscope body by the operator further aggravate this situation. As a result, this means that the generic devices can be used to carry out the advanced H.A.L. method usually only in the case of relatively minor hemorrhoidal disorders, and particularly severe stages have to be operated on in the conventional manner with the abovementioned disadvantages.  
         [0007]     It is therefore an object of the present invention to improve a generic proctoscope designed for carrying out the H.A.L. method such that it can be used in a simpler and, from the patient&#39;s point of view, less painful manner and for a greater number of possible applications, and makes it possible to avoid or reduce the conventional need to administer drugs.  
       SUMMARY OF THE INVENTION  
       [0008]     The foregoing object is achieved by providing a proctoscope comprising a proctoscope body which is preferably hollow-cylindrical and is designed to be inserted into a patient&#39;s anus, said proctoscope body having a tapering at a distal end portion, an opening at the other end and also a handle portion, wherein the proctoscope body has a hole designed to form an operation window toward a free interior space of the proctoscope body, and means for illuminating the operation window and/or means for detecting vessels by means of sensors, in particular by means of ultrasound, may be provided in the proctoscope body, characterized in that the operation window is formed in the outer wall of the proctoscope body such that it extends into the tapering distal end portion.  
         [0009]     In an advantageous manner according to the invention, at the distal end portion (i.e. the insertion end of the proctoscope body), the hole which forms the operation window is formed such that it extends, preferably as a cut-out in the hollow-cylindrical proctoscope body or the conically tapering distal end portion, into the tapering region. Not only is the size of the operation window thus increased in comparison to known devices but also, with respect to a maximum diameter of the proctoscope body, a front (insertion) edge of the operation window is smaller than the maximum diameter, which on the one hand facilitates insertion of the proctoscope body and on the other hand at the same time largely reduces further irritation of the relevant hemorrhoidal artery. In particular, the disadvantageous scraping of the tissue over the edge of the operation window, as occurs in generic known devices, is thereby less severe.  
         [0010]     If then, as provided in one further development of the invention, the tapering distal end portion is at least partially formed of a solid material, e.g. plastic, the hemorrhoidal artery or the intestinal mucosa remains virtually unaffected by the insertion of the proctoscope and any further adjustment movements. Besides positive effects of the reduction in pain (and the avoidance of anesthesia which would otherwise be required), the device according to the invention is thus suitable even for treating hemorrhoidal problems in advanced stages, for example in the case of strangulated, thrombosed or fibrosed nodes, successfully and without requiring that the patient be kept in hospital. As a result, the present invention considerably expands the application possibilities of the H.A.L. method for treating hemorrhoids.  
         [0011]     According to one advantageous further development of the invention, it is provided that the proctoscope body cooperates with a push-in obturator which in particular has the function, when it is pushed in, of closing off the operation window on the inside and particularly preferably completely, in order then to be pulled out once the proctoscope body is inserted so that the operation window is freely accessible to the operator for further operation steps. The disadvantageous effect of operation window edges (which are still present) on the relevant blood vessel is hereby further reduced, or even completely prevented if the casing is appropriately rounded and the operation window is completely closed.  
         [0012]     In order to simplify handling of this obturator, the latter has at one end a handle portion which protrudes out in the inserted state and at the other end it is provided with a suitably tongue-shaped extension for reliably closing off the operation window.  
         [0013]     Particular preference is given to providing an ultrasound Doppler probe permanently on or in the proctoscope body, suitably adjacent to the operation window. By virtue of the permanent installation, preferably permanently integrated in the wall of the proctoscope body, cleaning problems can be overcome in a simple manner and, by means of the handle portion preferably designed as an angled grip, the ultrasound probe can then be easily pushed into its desired position or pivoted by the operator; the Doppler electronics, which are known per se and are connected to the ultrasound probe (it is particularly preferable to pass the corresponding supply lines through the appropriately hollowed-out handle portion), then allow simple reporting by signals as to the guidance and handling of the proctoscope.  
         [0014]     While one particularly preferred embodiment of the invention provides for use of an ultrasound Doppler probe, the invention equally includes the use of other methods, preferably imaging methods, for detecting the blood vessel, in particular according to the so-called duplex method.  
         [0015]     Moreover, it is particularly preferable within the scope of the present invention to make it easier for the operator to carry out a visual inspection. For this purpose, according to one development lighting means are provided in the interior space of the proctoscope body, wherein said lighting means may be provided either (seen from the opening or observation direction of the observer) in front of or behind the operation window. In addition or as an alternative, mirrors or other reflection means may be provided which make it easier for the operator to see the operation window (and the intervention site), even more preferably in the form of a backlit mirror.  
         [0016]     As a result, the present invention makes it possible to use the advanced H.A.L. method to treat hemorrhoids in a considerably more flexible manner and for a greater number of applications, wherein the discomfort of the patient is considerably reduced compared to generic known devices for an H.A.L. method and at the same time the operating comfort and flexibility in terms of operation can be greatly improved for the operator. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]     Further advantages, features and details of the invention emerge from the following description of preferred examples of embodiments and with reference to the drawings, in which:  
         [0018]      FIG. 1  shows a side view of the proctoscope according to a first preferred embodiment of the present invention;  
         [0019]      FIG. 2  shows a longitudinal section through the arrangement of  FIG. 1 ;  
         [0020]      FIGS. 3, 4  respectively show a side view of and longitudinal section through an obturator for use with the arrangement of  FIG. 1  and  FIG. 2 ;  
         [0021]      FIG. 5  shows a front view from the side of the closure portion on the obturator of  FIG. 4  and  
         [0022]      FIG. 6  shows a sectioned side view through the arrangement of  FIG. 2  with the obturator of  FIG. 3  pushed in. 
     
    
     DETAILED DESCRIPTION  
       [0023]     The proctoscope of  FIG. 1  and  FIG. 2  consists, as can be seen particularly clearly from the sectional view, of a proctoscope body  10  made of a suitable plastic material (typically PPSU) with a handle portion  14  which projects at right angles to a hollow-cylindrical central portion  12  of the proctoscope body  10 . Central portion  12  and handle portion  14  are joined by a transition or opening portion  16  which (cf.  FIG. 2 ) conically widens a constant cylindrical inner width of the central portion  12  (typical inner diameter 20 to 22 mm) and thus forms at the end an intervention or observation opening  18 .  
         [0024]     At the other end the central portion  12  has, at the so-called insertion or distal end, a tapering proctoscope tip  20  which is essentially formed of solid plastic material.  
         [0025]     As can be seen in  FIGS. 1 and 2 , in the transition region between the conically tapering proctoscope tip  20  and the central portion  12 , an operation window  22  is formed by making a cut-out in the hollow-cylindrical central portion  12  (in the cross-sectional direction). More specifically, this cut-out which forms the operation window  22  is made in such a way that it extends over its main region essentially parallel to the axis of symmetry or longitudinal axis through the central portion  12 , and only in the front region toward the proctoscope tip  20  does it describe a slight angle bent outward.  
         [0026]     In this way, a hole is made in the central portion  12  and the proctoscope tip  20 , said hole having an effective cross-sectional area of between 350 and 400 mm 2 , this being a significant increase compared to operation windows of conventional devices (which are formed only in the cylindrical casing walls of a central portion). Moreover, the partially solid design of the proctoscope tip  20  with the plastic material ensures that an operation opening is produced, in particular at the critical insertion side, which is easy to clean, mechanically stable and gives the patient minimum discomfort.  
         [0027]      FIG. 2  additionally shows, in the sectional view from the side, an ultrasound sensor unit  24  which is provided directly adjacent to the operation window  22  in the direction toward the grip  14 , specifically such that the crystal element of the sensor is permanently surrounded by the plastic material of the proctoscope body  10 . Shown only schematically is a supply line  26  ( FIG. 1 ) which takes the ultrasound signals to and from an externally provided ultrasound Doppler unit (known per se) for vessel diagnosis, said signals being carried within the proctoscope via connections (not shown in more detail).  
         [0028]     The supply line  26  also supplies lighting means provided within the proctoscope body  10 , on the one hand a proximal lighting means  28  provided to the right above the operation window  22  and on the other hand a distal lighting means accommodated in the rear region of the proctoscope tip  20  behind an angled glass element  30 , said distal lighting means additionally being surrounded by a schematically shown reflector element  34 .  
         [0029]     By virtue of its positioning at an angle above the operation window  22 , the glass element  30  firstly ensures that an observer looking into the proctoscope through the opening portion  16  can see the operation window or a body surface exposed therein; on the other hand, the element  30  is designed such that luminous radiation of the second distal lighting means  32  can pass unhindered through said element and reach the operation window  22 .  
         [0030]     FIGS.  3  to  5  show an obturator element  36  as an important accessory part for the arrangement of  FIG. 1  and  FIG. 2 ;  FIG. 6  shows the units in the pushed-in (assembled) state.  
         [0031]     A plastic obturator  36  made of an appropriate material suitable for medical purposes (e.g. PPSU) has a solid-cylindrical portion  38  which is adapted to the inner diameter of the central portion  12 . Formed in the upper region (cf. the front view of  FIG. 5 ) is a longitudinal groove  40  which extends along the portion  38  and which—as a dual function—on the one hand accommodates and guides the slightly protruding proximal lighting means  28  and on the other hand ensures that, as the obturator element  36  is guided into and out of the proctoscope body  10 , no air is introduced into or taken out of the interior space, and thus no irritation to the patient&#39;s body exposed through the operation window  22  is caused on account of a negative or excess pressure.  
         [0032]     At one end of the cylindrical portion  38 , the obturator element  36  has a handle portion  42  which (cf. the completely pushed-in state shown in  FIG. 6 ) additionally forms a conically tapering stop element  44  for a fixed seat in the opening portion  16  and projects backward from the overall arrangement.  
         [0033]     At the other end, a closure portion  46  is integrally formed in one piece on the portion  38  in the manner of a tongue-like protrusion  46 , which closure portion (cf. the sectional view in  FIG. 6 ) completely and tightly closes off the operation window  22  in the pushed-in state of the obturator element  36  and additionally ensures a step-less, smooth transition between the outer surface and the proctoscope tip  20 . For this purpose, in a manner corresponding to the tapering of the proctoscope tip  20 , the closure element  46  is designed to taper slightly at the end.  
         [0034]     For use, in the normal case the operator fits the proctoscope shown in  FIG. 1  and  FIG. 2  together with the obturator element shown in  FIG. 3  and  FIG. 4 , and thus obtains the arrangement of  FIG. 6 . The operation window  22 —which is typically oval—is completely closed, and the transition to the proctoscope tip  20  is step-less. This arrangement is then inserted by the operator into the patient&#39;s anus, and in the process the hemorrhoidal artery slides along the proctoscope tip  20  to the closure element  46  without any complications. Correct positioning takes place by means of the signals generated by the ultrasound sensor unit  24  (and sensor electronics connected downstream). The handle portion  14  also serves to orient the operator and for external observation, said handle portion, with respect to the position of the ultrasound sensor unit  24 , being aligned with the latter and thus indicating the position thereof in the circumferential direction. At the operation site, i.e. in the desired position of the overall arrangement shown in  FIG. 6 , the operator then pulls the obturator element  36  out of the arrangement, and the operation window  22  is opened. Using operation techniques known per se from the H.A.L. method, the operator can then treat the relevant blood vessel in an appropriate manner; the lighting means  28 ,  32  which can be adjusted in terms of light intensity provide him with ideal observation conditions.  
         [0035]     The present invention is not restricted to the example of embodiment described above. For instance it is possible in particular to form the proctoscope of any suitable material and in any dimensions, in particular including with respect to the specific configuration of the operation window, wherein the dimensions shown—length and width of the operation window approximately 30×24 mm, cut-out depth of the operation window with respect to the circumferential diameter approximately 26 mm—have been found to be advantageous.  
         [0036]     While it was preferred within the context of the described example of embodiment to provide an ultrasound sensor unit, as an alternative it is advantageous and preferable to provide a different (imaging) sensor unit, in particular as a unit operating in accordance with the duplex method.  
         [0037]     With regard to the ultrasound electronics assigned to the permanently installed sensor element  24 , all possibilities for ultrasound diagnosis may be used, as are known per se and sold in particular including by the applicant.  
         [0038]     The present invention thus provides an instrument by virtue of which the advantageous operation technique of Hemorrhoidal Artery Ligation can be extended to additional further fields of application, as a result of which both the flexibility of use of this patient-friendly, non-invasive method and the discomfort to the patient himself can be considerably reduced.