# Patent

## Title
Anoscope for ano-rectal diagnostic and surgery

## Abstract

A composite anoscope for ano-rectal diagnostic and surgery, wherein the anoscope (2) also comprises an internal component (1), to be inserted therein, and a suitably shorter external component (3), ending with a conic frustum mantle (18), wherein the anoscope (2) is to be inserted. The three components (1, 2, 3) are all conic frustum shaped hollow bodies having circular cross-section. The internal component (1), when inserted in the anoscope (2), forms therewith a single body having a compact and smooth external surface and an ogival tip. The external component (3) is provided close to its mouth with slotted wings (19, 20), to be fixed to the perianal skin for securing the whole composite anoscope during the diagnostic and surgical operations.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of U.S. patent application Ser. No. 13/675,366, filed on Nov. 13, 2012, which is a continuation of U.S. patent application Ser. No. 12/090,345, filed on Apr. 15, 2008, now U.S. Pat. No. 8,337,401, which is a National Stage Entry under 35 U.S.C. §371(a) of International Patent Application No. PCT/IT2005/000619, filed on Oct. 26, 2005, the entire contents of each of the above-identified applications being incorporated by reference herein.


The present invention generally relates to an anoscope for ano-rectal diagnostic and surgery and particularly to a composite anoscope consisting of three conic frustum shaped components to be inserted one in each other.
Anoscopes are surgical instruments used for exploring the anal canal and the lower third portion of the rectum. Anoscopes usually are cylindrical pipes to be introduced in the anal canal by means of an appropriate introduction device. Composite anoscopes are also known, that is, anoscopes associated with one or more components, which, further to exploring the anal canal, permit performing ano-rectal surgery such as hemorrhoidectomy.
From U.S. Pat. No. 6,126,594 is known for example an anoscope which may be combined with another cylindrical component and wherein the latter is to be inserted. Said anoscope is provided with longitudinal slots, which are separated by lamellar protrusions. This geometry allows suturing a plurality of hemorrhoids located about the inner perimeter of the rectal wall. This known anoscope shows many drawbacks, of which one is that its introduction into the anal canal is traumatic because of the protuberance of the lamellar protrusions from the internal component which can damage the adjacent tissues. Furthermore, there is no stable system for positioning and fixing the anoscope when in use.
From U.S. Pat. No. 6,142,933 there is also known a composite anoscope consisting of three components for suturing hemorrhoids when performing hemorrhoidectomy. Also this known anoscope shows some drawbacks, of which one is that it is provided only with a single operative opening. Further, it is susceptible of moving inside the anal canal during the surgery, therefore it doesn't permit determining exactly the position of injuries with respect to the anal margin.
The exact depth of the suture is an essential parameter both when treating hemorrhoids and when treating other ano-rectal pathologies. An operative opening which is too wide, exposes the surgeon to the risk of suturing also the muscular tunica, in addition to the rectal mucosa. The distance of the suture from the anal margin is another essential parameter for this type of surgery. Finally, also the circumferential extension of the suture is very important, in fact in some cases it is necessary to perform 180°-sutures, in other cases 360°-sutures, etc.
The above mentioned known anoscopes do not permit a certain evaluation of the distance from the anal margin and entrust to the skills and expertise of the surgeon the exact performance of the surgery. They do neither allow evaluating exactly the circumferential extension of the sutures, nor allow determining the distance of the sutures from the anal margin, nor permit fixing the anoscope to the anal tissue during the surgery.
Hence, the scope of the present invention is providing a composite anoscope free from the disadvantages mentioned above. Such scope is achieved by the composite anoscope according to the present invention the features of which are specified in claim 1. Further features of this anoscope are specified in the dependent claims.
The anoscope according to the present invention offers the advantage that its three components, when introduced in the anal canal, constitute a conic frustum shaped single body having an ogival tip and a compact and smooth external surface apted to penetrate in the anal canal in a very atraumatic way.
Another advantage offered by the anoscope according to the present invention is that the external component permits fixing the anoscope by suturing it to the perianal skin, so that its positioning is precise and stable during the whole surgery.
Still another advantage of the anoscope according to the present invention is that its internal surface is provided with longitudinal and circumferential markers which provide an exact location of the position of the injuries in the anal canal allowing suturing at the right depth, at the right distance from the anal margin and with the right circumferential extension.
A further advantage of the anoscope according to the present invention is that it is provided with lamellar protrusions, which at the end are curved towards the ogival tip for giving the right support without damage to the rectal mucosa prolapsing above the tip of the anoscope.



These and other advantages of the composite anoscope according to the present invention will be evident to those skilled in the art from the following detailed description of an embodiment thereof with reference to the enclosed drawings wherein:
FIG. 1 shows a perspective view of the composite anoscope mounted ready for use, wherein the three components are one inserted inside the other,
FIG. 2 shows a perspective view of the internal component;
FIG. 3 shows a perspective view of the anoscope;
FIG. 4 shows a perspective view of the external component.



FIG. 1, shows that the composite anoscope according to the present invention consists of three hollow conic frustum shaped components which are apted to tightly inserted one in each other so that they form a single body. The geometry and the diametral dimensions of the three components, when these are combined, make the external surface of the instrument smooth and compact allowing in this way above all its easy and atraumatic introduction in the anal canal. The anoscope is the intermediate component 2 in which the internal component 1 is inserted and both of them are axially inserted in the external component 3. Inserting one component in the other in this order is possible because the diameter of external component 3 is slightly larger than the diameter of the anoscope 2, so that the latter can be inserted without play in the external component 3. Similarly, the diameter of component 1 is slightly shorter of the diameter of anoscope 2.
The conicity of the three components permits the reciprocal introduction and extraction of the components without any difficulty, solving the mounting problem which is typical of cylindrical geometries, as seen in one of the anoscope of the prior
FIG. 1 shows that the ogival tip of the composite anoscope according to the present invention is the result of the peculiar fitting of the cut off ogival tip of anoscope 2 together with the underlying complete ogival tip of component 1. As it will be explained in detail later, the dimensions and the geometry of the ogival tips of the anoscope 2 and of the internal component 1 are conceived for creating a system of hollow and solid features which become integral to each, other when mounted, forming a single body, having smooth and compact external surface, thereby solving one of the problems at the basis of the present invention.
FIG. 2 shows that the component 1 consists of a hollow conic frustum shaped body having attached to the mouth a flange 5, a mantle 4 and an ogival tip 6 at the opposite end. The flange 5 is provided with a handle 7 which permits handling the component 1 correctly, both when mounting the composite anoscope according to the present component and during its use in anoscopy and in other surgical operations. In the present embodiment, the internal component 1 is provided with a snapping tongue device 8, forming in this way a single body with the anoscope 2.
The conic frustum shaped body of the component 1 is provided with a set of parallel longitudinal grooves 9, radially placed and equidistant from each other with respect to the circular cross-section of said body. The grooves 9 extend approximately from the middle of the conic frustum shaped body of the component 1, that is where the mantle 4 ends, to the ogival tip, which is closed.
FIG. 3 shows that the anoscope 2 is a hollow conic frustum shaped body as well, having a flange 10 attached to its mouth. Said flange 10 is provided with at least one handle 11 for handling the anoscope during mounting operations and when in use. Similarly to component 1, also the anoscope 2 has a mantle 12 and an ogival tip provided with a set of parallel longitudinal slots 13 which connect the interior of the anoscope 2 with the surrounding environment. Said slots 13 are equidistant from each other and are separated by lamellar protrusions 14. The number of the lamellar protrusions 14 is the same as the number of the grooves 9 of the component 1, so that, when in use, the protrusions may close or open said slots for connecting the interior of the anoscope 2 with the surrounding environment.
The lamellar protrusions 14, close to their ends, have a curved portion 15 towards the centre in order to tightly fit the ogival tip 6 of the internal component 1. The longitudinal slots 13 of the anoscope 2 are separated from each other by lamellar protrusions 14 which prolong the hollow conic frustum shape of the mantle 12, almost until the ogival tip 6, so that there is an opening between the curved portions of the protrusions 14. Thus, the mantle 12 approximately forms the first half of the anoscope 2 while the lamellar protrusions 14 approximately constitute the second half.
When introducing the component 1 in the anoscope 2, the lamellar protrusions 14, due to their elasticity, slide in the grooves 9 and fill them completely so that respective distal-most ends 1 a, 2a of the component 1 and the anoscope 2 exist in the same plane, i.e., a plane that extends transversely with respect to a longitudinal axis “X” of the instrument, as shown in FIG. 1, to form a hollow conic frustum shaped body having a compact and smooth external surface and ending with an ogival tip. Thanks to this smooth and compact external surface, deriving from such peculiar fitting, the composite anoscope of the present invention can be inserted atraumatically in the anal canal.
When the anoscope according to the present invention is used, the lamellar protrusions 14, fitting the grooves 9 of the underlying component 1, prevent the prolapsing ano-rectal mucosa and the rectal muscular tunica from entering the grooves 9. In other words, the lamellar protrusions 14 support the ano-rectal mucosa and the rectal muscular tunica when exploring the injuries while allowing their exact location.
The internal surface of the anoscope 2 is preferably provided with circular and longitudinal markers positioned at predifined intervals. Such markers make it possible to exactly locate the distance of the injuries from the anal margin to thereby perform perfectly focused operations both in longitudinal and circumferential directions.
The flange 10 of anoscope 2 provides a through-holes' pattern 16, suitably equidistant, which can block the anoscope's 2 rotation inside the external component 3, which is provided with suitable posts 17 apted to fit into holes 16 as will be described afterwards.
Referring now to FIG. 4, the component 3, which is substantially shorter than the other components 1 and 2, is essentially a frustum conic body formed by a mantle 18, provided with slotted wings 19 and 20 attached to its major diameter. Mantle 4 of internal component 1, mantle 12 of anoscope 2, and mantle 18 of external component 3 have substantially the same length, as shown in FIG. 1. Wings 19 and 20 are used as handles and allow the right positioning of the whole composite anoscope inside the anal region. Further, wings 19 and 20 work as a seat in the insertion stroke of the composite anoscope inside the anal canal. This means that wings 19 and 20 have a double function: the first one as handles for the insertion of the anoscope inside the anal canal and the second one as end-stroke seat when the device contacts the anal region.
The slots 21 present in the wings 19 and 20 are used to fix in operation the composite anoscope according to the present invention by suturing external component 3 to perianal skin. Once such fixation has been effected through the above slots, the external component 3 provides both support and axial guide to anoscope 2 and internal component 1.
When anoscope 2 is axially inserted inside component 3, the internal posts 17 thereof fit the through-holes 16 placed on flange 10 of anoscope 2, thus blocking the relative rotation between the two components. In this way the anoscope's 2 angular position is fixed with respect to component 3, thus granting the maintenance of such position during the normal use of the composite anoscope according to the present invention. Obviously, the greater the holes' number on flange 10 and of the respective posts 17 inside the opening of component 3, the finer the degree of regulation of the relative position of anoscope 2 with respect to component 3.
Once the composite anoscope has been fixed to perianal skin by the external component 3, it is possible to axially extract the internal component 1 with handle 7 by disengaging the snapping tongue 8. In this way the inside of anoscope 2 is totally free, thus making it possible to explore the anal and ano-rectal region.
The anoscope according to the present invention is inserted into the anal canal once all of the three components have been tightly inserted into each other so to form one single body provided with an external surface which is smooth and compact, as shown in FIG. 1. After the external component 3 is fixed to the perianal skin by suturing the slotted wings 19 and 20 thereof, the internal component 1 can be removed. Subsequently, it is possible to rotate anoscope 2 inside the cavity of the external component 3 in order to position it so that portions of interest of the mucosa of the rectal wall prolapse into the slots interposed between lamellar protrusions 14. At this stage, anoscope 2 is fixed to the external component 3 by coupling the posts 17 of external component 3 to the holes 16 of flange 10 of anoscope 2. In this way, the anoscope has been tightly positioned inside the anal canal, realizing a fixed reference system during the whole operation. This measure allows making sutures at a proper distance from the anal margin and of a predefined circumferential extent. Further, anoscope 2 can eventually be extracted from the fixed external component 3, anyway leaving the anal canal open in order to introduce other surgical instruments.
Further variations and/or additions may be made by those skilled in the art to the hereinabove described and illustrated embodiments of the invention while remaining within the scope of the same invention. For example, it is obvious that the shape of anoscope's 2 and internal component's 1 handles can change while keeping the same function for the present invention. The same applies to the materials to be used for the construction of the three components or parts thereof. Any suitable material can be used, preferably polyethylene terephthalate.

## Claims

1. A method of performing a surgical procedure comprising:
assembling a surgical device by inserting an internal component into an anoscope such that a plurality of grooves defined by the internal component receive a corresponding plurality of protrusions extending distally from a body of the anoscope, whereby the plurality of protrusions are received in the plurality of grooves to define a smooth external surface of the assembled surgical device; and
inserting the surgical device into an internal worksite within a patient.

2. The method of claim 1, wherein inserting the surgical device into the internal worksite includes inserting the surgical device into the patient's anal canal.

3. The method of claim 1, wherein assembling the surgical device further includes inserting the internal component and the anoscope into an external component.

4. The method of claim 3, further including fixing the external component to the patient's tissue.

5. The method of claim 4, wherein fixing the external component to the patient's tissue includes suturing the external component to the patient's tissue.

6. The method of claim 5, wherein suturing the external component to the patient's tissue includes passing a suture through openings formed in wings extending radially outward from a body of the external component.

7. The method of claim 4 further including removing the internal component from the anoscope.

8. The method of claim 7 further including rotating the anoscope within the internal worksite to permit target tissue to pass through slots defined between the plurality of protrusions.

9. The method of claim 8, wherein rotating the anoscope within the internal worksite includes rotating the anoscope in relation to the external component.

10. The method of claim 8 further including fixing the anoscope to the external component.

11. The method of claim 10, wherein fixing the anoscope to the external component includes positioning at least one post extending from the external component within at least one corresponding hole formed in the anoscope.

12. The method of claim 8 further including removing the anoscope from the external component.

13. The method of claim 12 further including inserting a surgical instrument into the internal worksite through the external component.

14. A method of performing a surgical procedure comprising:
inserting an assembled surgical device into an opening in a patient's tissue, the surgical device including an external component, an anoscope positioned within the external component, and an internal component positioned within the anoscope, wherein the internal component defines a plurality of grooves and the anoscope includes a plurality of protrusions which are received in the plurality of grooves to define a smooth external surface of the assembled surgical device;
fixing the external component to the patient's tissue;
removing the internal component from the anoscope such that the plurality of protrusions of the anoscope are removed from the plurality of grooves defined by the internal component; and
receiving target tissue within slots defined between the plurality of protrusions extending distally from the body of the anoscope.

15. The method of claim 14, wherein inserting the assembled surgical device into the opening in the patient's tissue includes inserting the assembled surgical device into the patient's anal canal.

16. The method of claim 14, wherein fixing the external component to the patient's tissue includes suturing the external component to the patient's tissue.

17. The method of claim 16, wherein suturing the external component to the patient's tissue includes passing a suture through openings formed in wings extending radially outward from a body of the external component.

18. The method of claim 14, wherein receiving the target tissue includes rotating the anoscope in relation to the external component within the internal worksite such that the target tissue is received within the slots defined between the plurality of protrusions.

19. The method of claim 14 further including removing the anoscope from the external component.

20. The method of claim 19 further including inserting a surgical instrument into the internal worksite through the external component.