Patent Publication Number: US-2006009797-A1

Title: Anoscope

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
      This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/042,998, filed Jan. 9, 2002, which claims priority to Provisional Patent Application Ser. No. 60/260,724, filed Jan. 9, 2001. 
    
    
     TECHNICAL FIELD  
      This invention concerns an anoscope that is used during surgical procedures for removal or other treatment of hemorrhoids of man. More particularly, the anoscope includes hemorrhoid-receiving apertures that are positioned circumferentially about a tubular body that are in the proper anatomical positions to simultaneously present the hemorrhoids.  
     BACKGROUND OF THE INVENTION  
      Hemorrhoids in man may be located within the anal canal (internal hemorrhoids) or external to the anal canal (external hemorrhoids). Internal hemorrhoids are located proximal to the dentate line, which is a circumferential arrangement of anal glands located approximately 2-3 cm within the anal canal.  
      Because internal hemorrhoids are located proximal to the dentate line, where somatic sensory nerves are absent, they can be treated using non-operative procedures such as ligation, injection, infra-red coagulation or other means of destroying the hemorrhoidal tissue. This procedure avoids a surgical hemorrhoidectomy which is much more uncomfortable for the patient and is associated more potential complications.  
      Alternative methods of treating internal hemorrhoids also includes suture ligation, stapling, cryo-ablation, infra-red coagulation, injection sclerotherapy, or radiofrequency ablation, each of which may be performed in conjunction with the anoscope described herein.  
      Internal hemorrhoids in man are located in the left lateral, right anterior and right posterior locations. With the patient in the supine position, this translates into the 3, 7 and 11 o&#39;clock locations from the operator&#39;s perspective. With the patient in the prone position, this translates into the 9, one and five o&#39;clock position. With the patient in the left lateral position (for instance immediately following colonoscopy), this translates into the 6, 11 and 1 o&#39;clock positions.  
      My U.S. patent application Ser. No. 10/042,998 discloses a system of ligating internal hemorrhoids using a configured cylindrical anoscope, with lateral apertures, which correspond to the normal anatomic location of internal hemorrhoids in man. The current invention describes improvements upon the basic system and anoscope, which makes the procedure of hemorrhoidal ablation safer and easier for the operator, and therefore less uncomfortable for the patient.  
     SUMMARY OF THE INVENTION  
      The anoscope is to be used for eradicating internal anal hemorrhoids in man. It includes a tubular body and an obturator rotatively received in the tubular body. Either the tubular body or the obturator has at its distal end a bullet-shaped head that closes the distal end of the anoscope.  
      Three lateral hemorrhoid-receiving apertures are located in the tubular body at the normal anatomic locations of the internal anal hemorrhoids in man. Anal hemorrhoids are located in the left lateral, right anterior and right posterior locations, or 3, 7 and 11 o&#39;clock positions when man is in the supine position. The three hemorrhoid-receiving apertures formed in the tubular body of the anoscope each extend approximately one sixth of the circumference of the tubular body and are equally circumferentially spaced from on another.  
      The bullet-shaped head that forms the closed distal end configuration of the anoscope strengthens the anoscope and reduces the likelihood of damage of the anoscope “straps” or “fins” that form the apertures of the anoscope. The closed distal end of the anoscope also tends to prevent explosive release of gas and stool through the anal canal of the patient that might occur when using an open-ended anoscope.  
      In one embodiment of the invention a rotary obturator is used in the tubular body of the anoscope that includes an inner cylinder also with apertures at 3, 7 and 11 o&#39;clock positions that extend approximately one sixth of the circumference of the cylinder. The obturator is telescopically received in and is rotatable within the tubular body. The obturator may be rotated so that its apertures are aligned with the hemorrhoid-receiving apertures of the tubular body and the hemorrhoids will distend through the aligned apertures and are presented for ablation or other treatment by the physician. Also, the obturator may be rotated to move its apertures out of alignment with the hemorrhoid-receiving apertures of the tubular body to block the presentation of the hemorrhoids.  
      In another embodiment of the invention, the rotary obturator has only one aperture for selective alignment with one of the hemorrhoid-receiving apertures. This allows the presentation of the hemorrhoids one at a time.  
      The anoscope may include an alignment feature that indicates the relative rotary positions of the tubular body and the obturator.  
      The bullet-shaped head of the anoscope may be mounted on the distal end of the tubular body or on the distal end of the obturator. The head closes the otherwise open distal end of the anoscope.  
      In another embodiment of the invention, the obturator is telescopically received in the outer tubular body of the anoscope but is not intended to rotate. It carries the bullet-shaped head that functions to close the otherwise open distal end of the outer tubular body. The obturator may be removed from the outer tubular body when the anoscope is properly inserted in the anal canal to allow the physician to have more room to perform the surgical procedures.  
      A modified multiple hemorrhoidal ligator is available for use with the anoscope that includes a head assembly that is angulated at 1-90 degrees in order to more effectively ligate internal hemorrhoids. Another multiple ligator includes a rotatory ligator shaft assembly, whereby the shaft of the hemorrhoidal ligator may be rotated to predetermined positions, coinciding with the normal hemorrhoidal positions in man (for instance 3, 7 and 11 o&#39;clock). The shaft of the ligator may be rotated by means of lateral extensions extending from the proximal aspect of the shaft of the ligator, which may be rotated by the operator by applying rotational force, using the thumb or index finger. The combination of the modified closed-ended anoscope, the rotatory obturator, the angulated ligator head, the rotatory ligator and a means to rotate the ligator renders the procedure of hemorrhoidal ligation safer and easier to perform. The anoscope described herein contributes to the safety and ease of manipulation of the ligator. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a perspective view of the anoscope, showing the obturator withdrawn from the tubular body.  
       FIG. 2  is a side view of the anoscope showing the obturator withdrawn from the tubular body.  
       FIG. 3  is a cross-sectional view of the assembled anoscope, showing the hemorrhoid-receiving apertures of the tubular body and the apertures of the obturator in alignment with each other.  
       FIG. 4  is a cross-sectional view of the anoscope, similar to  FIG. 3 , but illustrating a modified obturator that has one aperture that registers with the hemorrhoid-receiving apertures of the tubular body one at a time.  
       FIG. 5  is a side cross-sectional view of the proximal end of the tubular body of the anoscope, showing how a removable handle is connectable thereto.  
       FIG. 6  is an end view of the proximal end of the tubular body of the anoscope, showing the removable handle, and showing an alternate connector position for the removable handle.  
       FIG. 7  is a side view of another embodiment of the anoscope, with the bullet shaped head of the anoscope mounted to the obturator.  
       FIG. 8  is a side view of another embodiment of the anoscope, with a modified obturator. 
    
    
     DETAILED DESCRIPTION  
      Referring now in more detail to the drawings, in which like numerals indicate like parts throughout the several views,  FIG. 1  shows an anoscope  10 , an external tubular body  12  and an internal tubular obturator  14 . The tubular body  12  includes a substantially cylindrically-shaped side wall  15  that defines an interior  16 , a distal end  18  for insertion in the anal canal of a patient and a proximal end  19  for positioning at the entrance of the anal canal.  
      In this embodiment, a bullet-shaped head  20  is mounted on the distal end  18  of the tubular body. The bullet-shaped head includes a rounded end  21  extending away from the tubular body  12  and a circular end  22  that is mounted to and merges into the cylindrically shaped side wall of the tubular body  12 .  
      A frustum-shaped flange  25  is mounted about the proximal open end  19  of the tubular body  12 . A handle  26  extends from the flange in a sloped, radial direction from the longitudinal axis  28  of the tubular body  12 .  
      Hemorrhoid-receiving apertures  30 - 32  are formed in the cylindrically shaped side wall  15  of the external tubular body  12 . The apertures  30 - 32  are elongated, with their lengths extending parallel to the longitudinal axis  28  of the tubular body  12 . The apertures  30 - 32  are defined by the intermediate support straps  34 ,  35  and  36 . Each hemorrhoid-receiving aperture  30 - 32  has a width that extends circumferentially about the cylindrically shaped side wall  25  of the tubular body  12 , with each aperture extending circumferentially approximately 60°. The intermediate support straps  34 - 36  preferably extend circumferentially 60° about the cylindrically shaped side wall.  
      As best shown in  FIG. 3 , the hemorrhoid-receiving apertures  30 - 32  are located at the 3 o&#39;clock, 7 o&#39;clock, and 11 o&#39;clock positions about the tubular body  12 . This corresponds to the correct anatomical positions of the anal hemorrhoids of man in the supine position.  
      The hemorrhoid-receiving apertures  30 - 32  are located at the distal end  18  of the tubular body  12 , extending from the distal end toward an intermediate position between the distal end and the proximal end  19  of the tubular body. This leaves an unapertured portion of the tubular body at its proximal end  19 .  
      When the tubular body  12  is inserted into the anal canal, the hemorrhoid-receiving apertures  30 - 32  will be located in the vicinity of the hemorrhoids of man, but the proximal end  19  that has no apertures will be located at the entrance to the anal canal.  
      Obturator  14  is cylindrically shaped and is sized and shaped so as to be telescopically received within and rotatable within the interior  16  of the tubular body  12 . It forms an interior space  47 . The obturator includes elongated apertures  41  and  42  formed therethrough that are sized and shaped to simultaneously align with the apertures of the tubular body. The elongated apertures  40 - 42  each also extend 60° about the circumference of the obturator, leaving intermediate support straps  44 ,  45  and  46 . The support straps also extend 60° about the circumference of the obturator.  
      The apertures  40 - 42  of the obturator are also located adjacent the distal end  48  of the obturator, leaving an unapertured proximal end  49 . The apertures  40 - 42  are shaped, sized, and positioned so as to accurately register with the hemorrhoid-receiving apertures  30 - 32  of the tubular body  12 .  
      Handle  50  is mounted to the proximal end  49  of the obturator, and extends at an angle from the longitudinal axis of the obturator that is similar to the angle at which the handle  26  extends from the longitudinal axis of the tubular body  12 . With this arrangement, when the handles  26  and  50  are oriented adjacent and parallel to each other, the elongated apertures  40 - 42  of the obturator will be in complete registration with the hemorrhoid-receiving apertures  30 - 32  of the tubular body  12 .  
      When the three elongated apertures  40 - 42  of obturator  14  are in registration with the hemorrhoid-receiving apertures  30 - 32  of the tubular body  12 , and when the handles  26  and  50  are oriented in the 12 o&#39;clock position with the patient in the supine position, the apertures  30 - 32  and  40 - 42  will be at the 3, 7 and 11 o&#39;clock positions as shown in  FIG. 3 , which will be in registration with the natural positions of the hemorrhoids of the human body. The hemorrhoids tend to protrude through and be presented within the interior  16  of the anoscope and within the interior  47  of the obturator, and can be viewed by the physician. With this arrangement, the handles become an alignment means for indicating the rotary position of the hemorrhoid-receiving apertures of the outer tubular body with respect to hemorrhoids of the patient and of the rotary position of the apertures of the obturator with respect to the outer tubular body.  
      Another alignment means may include a recess  55  ( FIG. 2 ) on the inside surface of the tubular body  12  at the interior proximal end  19 , and a protrusion  56  at the exterior proximal end  49  of the obturator. The alignment protrusion  56  registers with the alignment recess  55  when the obturator  14  is moved telescopically into the interior  16  of the tubular body  12  and the apertures are aligned. The alignment protrusion  56  tends to “click” into the alignment recess  55 , making a slight clicking noise, and tending to resiliently maintain the obturator in its position where its elongated apertures  40 - 42  are maintained in alignment with the hemorrhoid-receiving apertures  30 - 32 .  
       FIG. 4  illustrates a modified obturator  14 A that includes only one elongated aperture  60  that registers with any one of the hemorrhoid-receiving apertures  30 - 32 . Since there is only one elongated aperture  60  formed in the obturator  14 A, the obturator is capable of registering with the hemorrhoid-receiving apertures one at a time, by rotating the obturator.  
      While the handles of the tubular body  12  and the obturator  14  have been indicated as being permanently mounted, it is possible to mount the handles  26  and  50  in adjustable positions. For example,  FIGS. 5 and 6  illustrate a handle  26 A that is releasably connected to the frustum shaped flange  25  of the external tubular body  12  of the anoscope. An elongated flat bar  62  that forms a handle has a connector end  63  formed with an angled terminal end  64  and a tang  65  that is struck from the bar at a position removed from the angled terminal end. The frustum shaped flange  25  has a connector opening  66  formed therein and the angled terminal end  64  is inserted through the connector opening  66 . The tang  65  engages the outer perimeter of the frustum shaped flange  25  so that the handle becomes rigidly, but releasably, mounted to the tubular body  12 .  
      As shown in  FIG. 6 , more than one connector opening  66  can be formed in the frustum shaped flange  25  so that the handle  26 A can be connected at more than one position about the frustum shaped flange. Since the connector openings  66  will be located in predetermined positions about the frustum shaped flange  25 , the positions of the hemorrhoid-receiving apertures  30 - 32  will be understood by the position of the handle.  
      If desired, the removable handle may be used by the physician to insert and orient the anoscope and then removed from the anoscope. Also, the handles  26  and  50  may be of different dimensions and shapes to be compatible with their uses.  
      In the embodiment shown in  FIGS. 1 and 2 , the bullet-shaped head  20  closes the distal end of the obturator  12 . When in use, the head  20  engages the adjacent surfaces of the anal canal so that internal gasses and matter are retarded passing from the bowels and through the anoscope. The sealing of the obturator at its distal end from the passage of gas or fecal matter into the interior  16  of the tubular body and the interior  47  of the obturator protects the physician. Also, when the anoscope is in its proper position within the anal canal of the human body with its apertures  30 - 32  and  40 - 42  aligned with the hemorrhoids of the patient, the hemorrhoids can be washed or otherwise cleansed or treated with the head  20  maintaining the distal end of the anoscope sealed from the internal aspect of the bowels.  
       FIG. 7  illustrates a modified anoscope  10 A, whereby the bullet-shaped head  20 A is mounted to the distal end  48 A of the obturator  14 A, and the tubular body  12 A is open-ended. With this arrangement, when the obturator  14 A is fully telescopically received in the tubular body  12 A, the bullet shaped head  20 A will protrude from the open end of the tubular body  12 A, thereby closing the distal end  18 A of the tubular body. With this arrangement, the obturator  14 A can be withdrawn from the tubular body  18 A for access by the physician to the portions of the anal canal that extend beyond the tubular body  12 A.  
      It will be noted that the anoscope will be used with its apertures always aligned with the natural positions of the hemorrhoids of man. In the preferred embodiment, the handles  26  and  50  of the tubular body and the obturator will always be oriented toward the spine of the patient to achieve proper rotary position of the apertures  30 - 32  and  40 - 42 .  
      Alternative embodiments of the anoscope may be constructed that include locating the apertures and handle at other relative positions, in order to facilitate hemorrhoidal ligation, with the patient in alternative positions. For example, with the patient in prone position, and the handle at the 12 or 6 o&#39;clock position, the apertures are then located at 9, 1 and 5 o&#39;clock positions, from the operators perspective. Alternatively, with the patient lying in the left lateral position, and the handle of the anoscope parallel to the patients spine (i.e. 9 or 3 o&#39;clock position), the apertures are then located at the 6, 11 and 1 o&#39;clock positions. This latter scenario occurs during colonoscopy, when the patient lays in the left lateral position (i.e. lying on their left side). This is an ideal time to perform hemorrhoidal ligation, since the patient is already sedated, has undergone a mechanical bowel prep, and is under hemodynamic monitoring. The alternative positions of the handle and apertures therefore makes combined colonoscopy and hemorrhoidal ligation an efficient and simple procedure.  
      The relative locations of the anoscope handle, and the lateral apertures is therefore variable, depending on the position of the patient, and the preference of the operating surgeon. To facilitate the procedure, and to make all potential combinations of handle and apertures available to the operator, an alternative embodiment of the anoscope incorporates a handle, which rotates around the axis of the anoscope. In this embodiment, all potential combinations of handle and apertures are available, and the handle can be “preset” to any desired position. For example the handle may be set and the 12 o&#39;clock position and the apertures at 3, 7 and 11 o&#39;clock, for a patient in supine position. Alternatively, the handle may be preset at 9 o&#39;clock and the apertures at 6, 11 and 1 o&#39;clock for a patient in the left lateral position. This embodiment of the anoscope is therefore more convenient and versatile for the procedure of hemorrhoidal ligation and therefore makes the procedure easier for the operator and less uncomfortable for the patient.  
      The open-ended configuration of the anoscope has the limitation of allowing gas and bowel content to escape, once the obturator is removed. This is not only very unpleasant for the operator, but potentially dangerous. The current invention describes a closed-ended, generally bullet-shaped anoscope, which reduces the likelihood of this happening and protects the operator. In addition the closed-ended configuration adds mechanical stability to the intervening straps, located between the apertures. The mechanical support afforded by the distal closed-ended tip prevents fracture of the straps, which could potentially cause injury to the patient  
      When the inner cylinder is rotated 60 degrees, into the “open” position, the apertures of the inner and outer cylinders now register, and the internal hemorrhoids protrude into the interior of the anoscope, ready for ligation. The closed end of the anoscope reduces the likelihood of escape of any material through the anoscope.  
      Internal hemorrhoids may protrude to various degrees into the interior of the anoscope, depending on their size. It is difficult to ligate the smaller hemorrhoids if they protrude very little in to the lumen of the anoscope. When ligating with a suction ligator such as described by Ahmed (U.S. Pat. No. 6,149,659), the distal tip of the suction ligator may be angulated in order for the suction tip of the ligator to effectively make end-on contact with a hemorrhoid, so facilitating ligation. The angulation may be fixed from 180-90 degrees, more preferably from 120-60 degrees or most preferably at 45 degrees, to the axis of the ligator shaft. In an alternative embodiment, the angulation of the ligator tip may be variable, and adjusted by the operator depending on the individual anatomy of the patient.  
      Prior art also requires the ligator to be reinserted three separate times, at a different angle in order to ligate each of the three individual internal hemorrhoids. Rather than re-inserting the suction ligator multiple times at different angles, the shaft of the suction ligator may be rotated about its own axis, so the angulated head makes end-on contact with each hemorrhoid, without removing it from the anoscope.  
      The shaft of the ligator may be rotated by means of rotating the shaft for instance by utilizing lateral extensions extending from the proximal aspect of the shaft of the ligator. These lateral extensions may be rotated by the operator by applying rotational force, using the thumb or index finger. The ligator shaft may be rotated to pre-designated points, to register with the lateral apertures of the anoscope i.e. at 3, 7 and 11 o&#39;clock, or 9, 1 and 0.5 o&#39;clock and so forth. Arrival at the pre-designated point may be indicated by visual, auditory or tactile means. In one embodiment, the operator may feel a “click” as the shaft of the ligator and the anoscope apertures register. This may be easily accomplished by having grooves and protuberances on the shaft of the ligator and its housing at the appropriate locations. Other embodiments of the alignment means may include a system of colors, figures or numbers arrayed circumferentially on the proximal aspect of the ligator shaft and its housing.  
       FIG. 8  shows another embodiment of the anoscope  70  that includes an obturator  71  that has a bullet-shaped head that is telescopically received in and protrudes from the distal end of the outer tubular body  72 . The outer tubular body  72  has its hemorrhoid-receiving apertures  73 ,  74  etc. positioned as described above, at the 3, 7 and 11 o&#39;clock positions of the patient. The obturator  71  does not have the circumferentially spaced apertures as described above and is not intended to be rotated, but is for selectively closing the open distal end of the outer tubular body and for ease of insertion in the anal canal. Once the anoscope is properly positioned in the anal canal, the obturator  71  may be removed from the tubular body  72  out through its proximal end.  
      Although preferred embodiments of the invention have been disclosed in detail herein, it will be obvious to those skilled in the art that variations and modifications of the disclosed embodiments can be made without departing from the spirit and scope of the invention as set forth in the following claims.