Proctoscope and method for using a proctoscope

EP4565110A1Pending Publication Date: 2025-06-11PRIMED HALBERSTADT MEDIZINTECHN
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Patent Information

Application Number
EP2023757510
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-08-05
Filing Date
2023-07-25
Publication Date
2025-06-11

AI Technical Summary

Technical Problem

Existing proctoscopes lack precise assessment of circumferential thread extent and distance from the anal edge, fail to securely fix during operations, and allow unwanted rotations, leading to tissue torsion and impaired surgical visibility.

Method used

A three-part proctoscope design featuring a fastening ring with a cylindrical or conical shape, a surgical tube with a rectangular window, and an obturator for secure fixation and rotation, allowing precise alignment and secure attachment to the anal tissue, with markings for easy orientation and thread attachment.

Benefits of technology

Enhances surgical precision, reduces patient discomfort, and improves handling by providing secure fixation, preventing tissue torsion and ensuring clear surgical visibility with easy alignment and rotation of the surgical window.

✦ Generated by Eureka AI based on patent content.

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Abstract

The problem addressed by the invention, which relates to a proctoscope (1) and a method for using a proctoscope (1), is to provide an improved proctoscope (1) with which surgical procedures in the region of the human rectum are made easier for the operator, while pain for the patients is reduced and the proctoscope (1) is easy to handle and can be economically produced. In terms of the arrangement, this problem is solved in that the securing ring (2) has multiple position markers (10), a positioning aid (11) in the form of a 12-hour marking, and multiple first locking elements (8), in that a second part is a surgical tube (9) which can be arranged in an inner diameter of the securing ring (2), has a second locking element (17) that can be interlockingly connected and fixed to one of the first locking elements (8), and has a truncated-cone-shaped or semi-spherical, at least partially closed first end (12) and a surgical window (13), which is a rectangular opening located substantially along a cylinder wall of the surgical tube (9), and in that a third part is an obturator (19) which can be introduced into the surgical tube (9) and radially fixed, has a first conical or semi-spherical closed end (20) adapted to the first end (12) of the surgical tube (9), and is introduced into the surgical tube (9) and radially fixed, entirely closing the surgical window (13).
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Description

[0001] Proctoscope and method for using a proctoscope

[0002] The invention relates to a proctoscope which is constructed in three parts and has as a first part a fastening ring which is open on its opposite sides and has a first region with an at least partially cylindrical shape or cylindrically conical shape and a flange-like second region.

[0003] The invention also relates to a method for using a proctoscope, wherein a three-part proctoscope is provided, wherein a first part is a fastening ring open on its opposite sides with a first region with an at least partially cylindrical shape or cylindrically conical shape and a flange-like second region and wherein the proctoscope can be inserted into a rectum of a patient.

[0004] This description describes a proctoscope used in surgical procedures involving the human rectum, also known as an anoscope or surgical proctoscope. This proctoscope is designed with several parts. It is used for visual examination of the rectum and as an aid in rectal procedures.

[0005] Such proctoscopes or anoscopes are known to be used for the treatment of hemorrhoids, rectoceles, and rectal mucosal prolapse. Proctoscopes or anoscopes are also used in performing mucopexy and recto-anal lifting, as well as for direct tissue diagnostics. Grade II-IV hemorrhoids are particularly treated. Using a proctoscope or anoscope, surgeons are able to perform minimally invasive and relatively painless procedures such as mucopexy or recto-anal lifting.

[0006] Various proctoscopes and anoscopes are known from the state of the art.

[0007] EP 3 310 246 B1 discloses an anoscope that can be used as a diagnostic and / or surgical instrument in the proctological field. The objective is to improve an anoscope that can be used in both surgical and diagnostic applications.

[0008] To solve this problem, an anoscope is provided which comprises a movable part which rotates within a fixed part and is provided with a window.

[0009] US 2008 / 0275306 A1 generally discloses an anoscope for anorectal diagnostics and surgery, and in particular, a composite anoscope consisting of three truncated cone-shaped components that are intended to be inserted into one another. The objective is to provide a composite anoscope that is free of the disadvantages known from the prior art. These disadvantages are that known anoscopes neither allow for an exact assessment of the circumferential extent of the threads nor for a determination of the distance of the threads from the anal verge. Furthermore, no fixation of the anoscope to the anal tissue during surgery is provided.

[0010] The anoscope according to the invention offers the advantage that its three components, when introduced into the anal canal, form a single truncated conical body with a pointed conical tip and a compact and smooth outer surface, which is suitable for penetrating the anal canal very quickly and atraumatically.

[0011] WO 2004 / 021874 A1 relates to an anoscope that can be used in proctology as a diagnostic and / or surgical instrument. The aim is to overcome the disadvantage that the surgical window only opens onto a defined area of ​​the speculum. This is intended to improve an anoscope that can be used in surgical practice.

[0012] To achieve this, an anoscope is provided comprising a first hollow body means open at opposite ends and a second hollow body means open at opposite ends, formably coupled to the first hollow body means and arranged to rotate coaxially therein, wherein the first hollow body means and the second hollow body means are provided with a window means arranged to make a portion of the rectal mucosa accessible, the window means having a dimension and a shape to enable the use of surgical means.

[0013] WO 002021021396 discloses an anoscope comprising an elongated hollow member having a longitudinal slot configured to receive tissue within an interior of the hollow member. The device also includes a clip applicator. The clip applicator includes a body slidably received within the slot and jaws at a distal end of the body configured to hold a ligating clip. The clip applicator further includes a piston slidably coupled to the body configured to actuate the jaws. When the clip applicator is inserted into the slot and the piston is moved relative to the body, the jaws close, deforming the ligating clip from an open position to a closed position around the tissue received in the slot.

[0014] These state-of-the-art proctoscopes do not have a so-called 12-hour position for rectoceles, i.e., a bulge in the lower rectum above the sphincter. One advantage of this position is that it allows for rectocele treatment.

[0015] Furthermore, the known solutions do not include a thread attachment by means of which a surgical thread can be attached to a part of the proctoscope. This type of thread attachment has the advantage that these attachments can be fixed during the operation in such a way that the surgeon's field of vision and working area is not impaired.

[0016] In addition, unwanted rotations of the proctoscope cannot be effectively prevented, which can lead to torsion of the patient's tissue with the corresponding disadvantages.

[0017] Furthermore, localizing the dentate line is difficult with current methods. The dentate line marks the transition between the insensitive mucosa of the rectum and the highly sensitive squamous epithelium of the anal canal and provides important guidance within the anal canal. Therefore, there is a need for an improvement to the current state of the art and thus for an improved proctoscope for surgical interventions in the human rectum.

[0018] The object of the invention is to provide an improved proctoscope with which operative or surgical interventions in the area of ​​the human rectum are made easier for the surgeon, whereby pain for the patient is reduced and whereby the proctoscope is easy to handle and inexpensive to manufacture.

[0019] In particular, the aim is to ensure easy handling by the surgeon and to improve the overview of the surgical area.

[0020] The solution is a three-part proctoscope, which consists of the components fixing ring, surgical tube and obturator.

[0021] The fastening ring, as the first part of the proctoscope, has a first region with an at least partially cylindrical or cylindrically conical shape and a flange-like second region. The fastening ring is hollow and open at the opposite sides or ends. The first side is located at the flange-like second region, and the opposite side is located at an end of the at least partially cylindrical or cylindrically conical first region facing away from the flange-like second region.

[0022] The fixation ring is also designed to be transparent to allow the localization of the dentate line.

[0023] The flange-like second region of the fastening ring is connected to a handle, which can be provided with a grip recess, for example for the thumb and index finger. The flange-like second region of the fastening ring also has a plurality of so-called fastening holes. Using these fastening holes, it is possible, for example, for a surgeon to sew the fastening ring in place using several skin sutures for the duration of a perianal intervention in order to ensure a secure hold of the proctoscope in the area of ​​the patient's rectum. The fastening ring preferably has a plurality of inwardly directed L-shaped first locking elements in its cylindrical first region. Using these first locking elements, it is possible to temporarily firmly connect or lock a so-called surgical tube to the fastening ring, whereby only one L-shaped first locking element is used for such a locking.Each of the L-shaped first locking elements allows the surgical tube to be locked in the fastening ring in a different position or orientation of the surgical tube relative to the fastening ring.

[0024] For this purpose, the surgical tube, with the obturator inserted into the surgical tube, is inserted into the fastening ring and locked into the first locking elements by means of a rotating movement that may only be a few degrees. The obturator simultaneously serves to push tissue back from the surgical window of the surgical tube when inserting the proctoscope and as a handle or extension of the gripping surface for loosening, rotating, and locking the surgical tube.

[0025] The mounting ring also features several position markers arranged at equal intervals along the circumference of the flange-like portion of the mounting ring. Such position markers indicate to a surgeon the orientation of a so-called surgical window of the proctoscope, through which the surgeon can perform a surgical procedure in the area of ​​the human rectum using suitable instruments.

[0026] In addition to these position marks, a positioning aid is provided in the form of a 12 o'clock mark, which, when the fixation ring is positioned accordingly in the rectum of a patient, points upwards on the human body in the direction of the spine or the head of the patient.

[0027] A second part of the proctoscope is the surgical tube. The surgical tube has a cylindrical or cylindrically conical shape and is designed as an elongated, hollow body. The surgical tube is truncated conically or hemispherically shaped at its first end, partially closed, with a substantially rectangular opening arranged substantially laterally or substantially along a cylindrical wall of the surgical tube at this end, which opening is referred to as the surgical window. It is also intended that the substantially rectangular opening of the surgical window partially protrudes into the truncated conical or hemispherical first end of the surgical tube.

[0028] The surgical window extends, for example, over one-third of the total length of the surgical tube, starting at the first end of the surgical tube. The surgical window is designed to be nearly rectangular and sized to allow a surgeon to perform a surgical procedure on the patient's tissue protruding within the surgical window. In an exemplary embodiment, the surgical window has a length of approximately 4 to 6 cm and a width of approximately 2 to 3 cm.

[0029] The surgical tube is designed with an opening at its second end, which is located opposite the first end. This opening essentially corresponds to the diameter of the cylindrical surgical tube at the second end. This opening can also be slightly larger than the diameter of the cylindrical surgical tube at the second end.

[0030] At this second end, the surgical tube is designed, for example, with corresponding holes or nubs along the circumference of the second end of the surgical tube so that it can be securely grasped and held by a surgeon. Furthermore, at least one first alignment marker, which can be provided with a thread attachment, is arranged at this second end.

[0031] To temporarily lock the surgical tube to the fastening ring, a second locking element is arranged at the second end of the surgical tube. This second locking element is designed such that it can snap into the first locking elements of the fastening ring. Such temporary locking can be achieved by means of a so-called bayonet lock, which, as is known, enables a quickly established and detachable mechanical connection between two cylindrical parts along their longitudinal axis. It is also provided that a radial fixation is arranged at the second end of the surgical tube for establishing a positive, snap-in connection with a further radial fixation formed on the obturator. The obturator is thus introduced into the surgical tube and connected to it in a positive fit or fixed to it in a snap-in manner.

[0032] It is further provided that the part of the system that can rotate in the fastening ring, i.e. the surgical tube, can be locked and thus fixed by turning it into, for example, 7 positions. These positions are preferably 1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock, and 12 o'clock, which are known, for example, from an analog clock face. These positions are indicated accordingly using the position marks and the 12 o'clock marking on the fastening ring. If the first alignment mark on the surgical tube is aligned with the 3 o'clock position mark on the fastening ring, the surgical window of the surgical tube is aligned in the 3 o'clock direction in the patient's rectum. The surgeon can thus perform a surgical procedure in this 3 o'clock direction. These relationships also apply to the other selectable positioning options at the positions 1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock and 12 o'clock.

[0033] The third part of the three-part proctoscope is the obturator, which has a substantially cylindrical or cylindrically conical, elongated shape. The obturator has a conical or hemispherical closure at its first end. This closure is designed so that it can be inserted into the surgical tube, thus completely closing the surgical window of the surgical tube. For this purpose, the outer diameter of the obturator is optimally adapted to the inner diameter of the surgical tube. For this purpose, the second end of the obturator, with its conical or hemispherical shape, is also optimally adapted to the second end of the surgical tube.

[0034] The second end of the obturator is designed, for example, with corresponding holes or nubs along its circumference so that it can be securely grasped and held by a surgeon. Furthermore, the second end of the obturator features a radial fixation with which the obturator can be positively connected to the surgical tube. Furthermore, the second end of the obturator features a second alignment mark.

[0035] The obturator is inserted into the surgical tube in such a way that the first alignment mark of the surgical tube, which can also be a suture attachment, aligns with the second alignment mark of the inserted obturator.

[0036] Completely closing the surgical window of the surgical tube with the obturator allows for improved, friction-reduced insertion of the proctoscope, stretching the muscular wall of the rectum but not damaging the mucosa.

[0037] In addition, safe rotation of the surgical window of the surgical tube to different positions is possible when the obturator is inserted into the surgical tube. After it has been rotated to the desired position, the obturator is removed from the surgical tube, thus exposing the surgical window of the surgical tube to the surgeon. Once the surgical procedure has been performed in this position, the obturator can be reinserted into the surgical tube, locked, and the surgical window closed. The surgical tube, with the inserted and locked obturator, is then rotated to a position desired by the surgeon. Once the desired position has been reached, the obturator is removed from the surgical tube, thus exposing the surgical window of the surgical tube to the desired position for the surgeon.

[0038] By making the fixation ring out of a transparent material, it is possible to locate the dentate line after the surgical tube with the obturator has been removed from the fixation ring.

[0039] It is provided that the surgical tube can be fixed in the fastening ring at at least 7 positions (1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock and 12 o'clock), with the 12 o'clock position being intended for rectocele procedures. According to the invention, it is also provided that the further radial fixation is I-shaped, with arc-shaped locking elevations being arranged on opposite parallel outer legs of the U-shaped further radial fixation, that the radial fixation is also U-shaped, with arc-shaped locking depressions being arranged on opposite parallel inner legs of the radial fixation, and that the arc-shaped locking elevations of the further radial fixation and the arc-shaped locking depressions of the radial fixation have corresponding, complementary shapes and engage with one another in a form-fitting manner when the obturator is inserted into the surgical tube.

[0040] The further radial fixation is designed as an elevation on the obturator with a U-shaped outer contour and, for example, two arched locking elevations arranged opposite one another on the parallel outer legs of the U-shaped further radial fixation.

[0041] The radial fixation is designed as a notch in the surgical tube with a U-shaped inner contour and, for example, two arcuate locking recesses arranged opposite one another on the parallel inner legs of the U-shaped radial fixation.

[0042] Due to the inventive design of the curved locking protrusions of the additional radial fixation corresponding to the curved locking recesses of the radial fixation, the obturator can be inserted into the surgical tube when the orientation of the radial fixation of the surgical tube matches the orientation of the additional radial fixation of the obturator. This insertion of the obturator into the surgical tube is continued until the curved locking protrusions of the additional radial fixation have reached the position of the curved locking recesses of the radial fixation and, due to their complementary shapes, engage with each other, thus creating a positive connection.

[0043] According to the invention, it is further provided that at least the obturator and the surgical tube are made of a material that can be used in medical technology, laboratory technology, and in the diagnostic field. Polypropylene homopolymers, such as Purell HP 373, Purell HP 371, PPH 9020, or PPM H250, are known for such applications. The material from which the obturator and the surgical tube are made should have a ball indentation hardness according to ISO 2039-1 of 55 to 70 MPa and a tensile modulus according to ISO 527-1, -2 of 1200 to 1700 MPa, i.e., it should have sufficient strength and be at least partially elastically deformable.

[0044] The deformability is particularly advantageous in the area of ​​the radial fixation and the further radial fixation, since the further radial fixation can be inserted into the radial fixation, even though the outer dimension of the further radial fixation, i.e. the maximum distance between the curved locking elevations, is greater than the inner dimension of the radial fixation of the surgical tube in the area of ​​the parallel inner legs, excluding the area of ​​the curved locking recesses.

[0045] In preparation for the use of the proctoscope 1 in a human rectum, the proctoscope, consisting of its fastening ring, surgical tube and obturator, is assembled in a first step, whereby the parts are connected or fixed to each other accordingly.

[0046] For this purpose, the obturator is inserted into the surgical tube, whereby it is important to ensure that the further radial fixation of the obturator (nose of the obturator) is fully engaged or positively connected to the radial fixation of the surgical tube (groove of the surgical tube) and that the obturator is fully inserted into the surgical tube.

[0047] To form this connection between the obturator and the surgical tube, it is provided according to the invention that the further radial fixation is provided in a U-shape, wherein arcuate locking elevations are provided on opposite parallel outer legs of the U-shaped further radial fixation, that the radial fixation is provided in a U-shape, wherein arcuate locking recesses are provided on opposite parallel inner legs of the radial fixation, and wherein the arcuate locking elevations and the arcuate locking recesses have corresponding, complementary shapes and engage with one another when the obturator is inserted into the surgical tube and produce a positive connection.

[0048] The surgical tube with the obturator inserted is then inserted into the fastening ring, and the second locking element of the surgical tube is connected or fixed with any of the seven first locking elements (bayonet locks) of the fastening ring. The surgical tube with the obturator inserted is thus fixed and locked in the fastening ring.

[0049] After the proctoscope has been lubricated, it can be inserted into the patient. Ensure that the handle of the fixation ring points toward the 6 o'clock position. It is helpful to pull both buttocks apart to insert the proctoscope as deeply as possible into the anal canal and rectum. This ensures that the fixation ring remains secure and correctly positioned during the procedure.

[0050] After the proctoscope has been inserted, it is secured via skin sutures through the holes at 12 o'clock, 5 o'clock and 7 o'clock.

[0051] To perform a surgical procedure, the obturator is then removed from the surgical tube arranged and fixed in the fastening ring.

[0052] The surgical window of the surgical tube is now exposed, and the surgeon can perform a surgical procedure in the area of ​​the human rectum. This can be performed at the location described as the 12 o'clock position if the surgical window has been aligned accordingly. To do this, the first alignment mark is aligned with the positioning aid or the 12 o'clock mark.

[0053] To select a different direction or position for the surgical window, the obturator is reinserted into the surgical tube. The second alignment mark on the obturator is aligned with the first alignment mark on the surgical tube.

[0054] This insertion of the obturator into the surgical tube completely closes the surgical window in the surgical tube. Once the obturator is inserted into the surgical tube and the surgical window is closed, safe rotation of the surgical tube and thus the surgical window to various positions is possible. This rotation or alignment of the surgical window can be performed in any direction indicated by the position marks on the attachment ring or the 12 o'clock mark.

[0055] To change the direction or position of the surgical window, the surgical tube must be unlocked with the obturator, completely withdrawn, and repositioned. Rotating the surgical tube in the anal canal must be avoided at all costs, as this could cause tissue torsion.

[0056] Depending on the indication, the surgical window of the surgical tube can be positioned at seven different locations, which are marked as indentations on the attachment ring (1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock, and 12 o'clock). The direction or position of the surgical tube window opening is indicated extracorporeally by the first alignment mark, which also serves as a suture attachment.

[0057] To perform a surgical procedure, the obturator is then removed from the surgical tube arranged and fixed in the fastening ring, thus exposing the surgical window of the surgical tube at the new position indicated by the position marks or the 12 o'clock mark.

[0058] Before removing the proctoscope from the rectum, the obturator can be reinserted into the surgical tube located in the attachment ring, locked, and thus closing the surgical window. The three skin sutures are then severed and the proctoscope removed. Alternatively, the attachment ring can be removed without the surgical tube and with the obturator inserted after the three skin sutures have been severed.

[0059] The advantages of the proctoscope according to the invention are in particular easy, simple handling for the surgeon, ergonomic design, striking design elements, • in a secure connection of the fastening ring with the surgical tube by means of a bayonet lock,

[0060] • in the possibility of attaching the surgical thread to the surgical tube,

[0061] • in a variety of alignment marks,

[0062] • in a marking of the surgical positions,

[0063] • in a cost-effective, outpatient surgical method using the proctoscope according to the invention.

[0064] The above-explained features and advantages of this invention will be better understood and appreciated after careful study of the following detailed description of the preferred, non-limiting exemplary embodiments of the invention with the accompanying drawings, which show:

[0065] Fig. 1 : the fastening ring of the proctoscope according to the invention,

[0066] Fig. 2a, 2b, 2c: further views of the fastening ring according to the invention,

[0067] Fig. 3a, 3b: the surgical tube of the proctoscope according to the invention,

[0068] Fig. 4a, 4b: the obturator of the proctoscope according to the invention,

[0069] Fig. 5: the obturator inserted into the surgical tube,

[0070] Fig. 6: the assembled proctoscope according to the invention,

[0071] Fig. 7a, 7b: further views of the proctoscope according to the invention,

[0072] Fig. 8: removing the obturator from the surgical tube,

[0073] Fig. 9: inserting the obturator into the surgical tube,

[0074] Fig. 10: releasing the surgical tube with obturator from the fastening ring,

[0075] Fig. 11 : turning the surgical tube with obturator in the fixing ring,

[0076] Fig. 12: the assembled proctoscope and

[0077] Fig. 13: an enlargement of the area of ​​radial fixation on the surgical

[0078] Tube and further radial fixation on the obturator.

[0079] Figure 1 shows a first part of the proctoscope 1 according to the invention, the fastening ring 2. The fastening ring 2 has a first region 3 with an at least partially cylindrical shape or cylindrically conical shape and a flange-like second region 4. The fastening ring 2 is hollow and open on the opposite sides or ends. The flange-like second region 4 of the fastening ring 2 is connected to a handle 5, which is provided with a grip recess 6, for example for the thumb and index finger. The flange-like second region 4 of the fastening ring 2 has three fastening holes 7 in Figure 1. By means of these fastening holes 7, the fastening ring 2 can be sewn perianally using three skin sutures for the duration of an intervention in order to ensure a secure hold of the proctoscope in the region of the patient's rectum.

[0080] The fastening ring 2 has, in its cylindrical first region 3, a plurality of inwardly directed L-shaped first locking elements 8. By means of these first locking elements 8, a surgical tube 9 (not shown in Figure 1) is temporarily firmly connected and locked to the fastening ring 2. For this purpose, the surgical tube 9 is inserted into the fastening ring 2 and, by means of a rotational movement that may only comprise a few degrees, is engaged in the first locking elements 8, as will be shown later.

[0081] The fastening ring 2 also has six position marks 10, which are arranged at equal intervals along the circumference of the flange-like second region 4 of the fastening ring 2. These position marks 10 indicate the orientation of a so-called surgical window 10 in the surgical tube 9 of the proctoscope 1. The surgical tube 9 with the surgical window 10 is not shown in Figure 1.

[0082] In addition to the six position markers 10, Figure 1 shows another positioning aid 11, a 12 o'clock marker. This 12 o'clock position is intended specifically for rectocele procedures.

[0083] Figures 2a, 2b and 2c show further views of the fastening ring 2.

[0084] For better comprehensibility, the fastening ring 2 already shown in Figure 1 is shown in a further perspective view in Figure 2a, a frontal view in Figure 2b, and a side view in Figure 2c. All elements shown in Figures 2a, 2b, and 2c have already been described in detail for Figure 1, so repetition is not necessary here. Figures 3a and 3b show the surgical tube 9 of the proctoscope 1 according to the invention in a perspective view in Figure 3a and a side view in Figure 3b.

[0085] The surgical tube 9 has a cylindrical shape or a cylindrically conical shape and is designed as an elongated, hollow body. The surgical tube 9 is designed to be partially closed at its first end 12, frustoconical or hemispherical. At this first end 12, an elongated opening is provided, which is arranged essentially laterally or essentially along a cylindrical wall of the surgical tube 9 and is referred to as a surgical window 13.

[0086] The surgical window 13 extends, for example, over one-third of the total length of the surgical tube 9, beginning at the first end 12 of the surgical tube. The surgical window 13 is designed to be almost rectangular and dimensioned such that a surgeon can perform a surgical procedure on the patient's tissue protruding in the surgical window.

[0087] The surgical tube 9 is provided with an opening at its second end 14, which is arranged opposite the first end 12. This opening essentially corresponds to the diameter of the cylindrical surgical tube 9 at the second end 14. This opening can also be designed slightly larger than the diameter of the cylindrical surgical tube 9 at the second end 14.

[0088] At this second end 14, the surgical tube 9 is designed, for example, with corresponding holes or nubs 15 along the circumference of the second end 14 of the surgical tube 9 such that it can be securely grasped and held by a surgeon. Furthermore, the first alignment marking 16 or a thread attachment 16 is arranged at this second end 14.

[0089] To temporarily lock the surgical tube 9 to the fastening ring 2, a second locking element 17 is arranged at the second end 14 of the surgical tube 9. This second locking element 17 is designed such that it can be engaged in one of the first locking elements 8 of the fastening ring 2. Such temporary locking can be achieved by means of a so-called bayonet lock, which, as is known, enables a quickly established and detachable mechanical connection between two cylindrical parts along their longitudinal axis. Depending on which first locking element 8 of the fastening ring 2 the second locking element 17 engages or forms a positive connection, the surgical tube 9 is fixed in one of the seven selectable positions (1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock, and 12 o'clock).

[0090] It is also provided that a radial fixation 18 for an obturator 19 (not shown in Figures 3a and 3b) is arranged at the second end 14 of the surgical tube 9, which obturator can be inserted into the surgical tube 9 and locked thereto.

[0091] In Figures 4a and 4b, an obturator 19 of the proctoscope 1 according to the invention is shown in two different perspective views.

[0092] The obturator 19 has a substantially cylindrical or cylindrically conical, elongated shape. The obturator 19 has a conical or hemispherical closure at its first end 20. The obturator 19 is designed such that it can be inserted into the surgical tube 9, thus completely closing the surgical window 13 of the surgical tube 9. For this purpose, the outer diameter of the obturator 19 is optimally adapted to the inner diameter of the surgical tube 9, and the first end 20 of the obturator 19, with its conical or hemispherical shape, is optimally adapted to the first end 12 of the surgical tube 9.

[0093] The second end of the obturator is designed, for example, with corresponding holes or knobs 15 along the circumference of the second end 21 of the obturator 19 in such a way that it can be securely grasped and held by a surgeon.

[0094] Furthermore, the second end 21 of the obturator 19 has a further radial fixation 22, with which the obturator 19 can be positively connected to the surgical tube 9. Furthermore, the second end 21 of the obturator 19 has a second alignment marking 23.

[0095] Figure 5 shows the obturator 19 inserted into the surgical tube 9. In preparation for the use of the proctoscope 1 in the rectum of a human, the proctoscope 1, consisting of its fastening ring 2, surgical tube 9 and obturator 19, is assembled in a first step, whereby the parts are connected or fixed to each other accordingly.

[0096] For this purpose, the obturator 19 is inserted into the surgical tube 9, whereby it must be ensured that the further radial fixation 22 of the obturator completely engages or is positively connected to the radial fixation 18 of the surgical tube and that the obturator 19 is completely inserted into the surgical tube 9.

[0097] This alignment between obturator 19 and surgical tube 9 is achieved when the second alignment mark 23 of the obturator 19 has been aligned with the first alignment mark 16 or the thread attachment 16 of the surgical tube 9, as can be seen in Figure 5.

[0098] The surgical tube 9 with the inserted obturator 19 is then inserted into the fastening ring 2, and the second locking element 17 of the surgical tube 9 is positively connected or fixed to any of the seven first locking elements 8 of the fastening ring 2. Thus, the surgical tube 9 with the inserted obturator 19 is fixed and locked in the fastening ring 2.

[0099] After the proctoscope 1 has been lubricated, it can be inserted into the patient. Note that the handle 5 of the mounting ring 2 points toward the 6 o'clock position.

[0100] After the proctoscope has been inserted, it is fixed via skin sutures through the attachment holes 7 at 12 o'clock, 5 o'clock and 7 o'clock.

[0101] If the obturator 19 has been inserted into the surgical tube 9 in this way, the surgical window 13 of the surgical tube 9 is closed by the obturator 19.

[0102] Figure 6 shows the assembled proctoscope 1 according to the invention.

[0103] As already explained, in preparation for use of the proctoscope 1 in a human rectum, the unit consisting of the surgical tube 9 and the inserted and fixed obturator 19 is inserted into the fastening ring 2 and secured, for example, by means of one of the first locking elements 8 arranged on the fastening ring 2 and the second locking element 17 attached to the surgical tube 9 in the manner of a bayonet lock. The process of inserting the unit, consisting of the surgical tube 9 and the fixed obturator 19, into the fastening ring 2 is represented by the first arrow 24. The process of fixing and locking the unit in the fastening ring 2 is represented by the second arrow 25.

[0104] The three-part proctoscope 1 is shown in Figure 6 in its assembled form, for example, inserted into the rectum. In this assembled form, the first end 12 of the surgical tube 9 is arranged at the first end 20 of the obturator 19, and the second end 14 of the surgical tube 9 is arranged at the second end 21 of the obturator 19.

[0105] In this assembled form, the positioning aid 11, the first alignment mark 16 or the suture attachment 16, and the second alignment mark 23 are arranged in an imaginary line. Such an imaginary line runs parallel to a longitudinal axis of the surgical tube 9 and / or obturator 19 elements.

[0106] In this assembled form, the surgical window 13 of the surgical tube 9 is completely closed by the obturator 19. The closed surgical window 13 enables improved, friction-reduced insertion of the proctoscope 1, stretching the muscular wall of the rectum but not damaging the mucous membrane.

[0107] Representations of the proctoscope 1 in the area of ​​the human rectum have been omitted from the figures, as this is sufficiently known to the person skilled in the art.

[0108] Figures 7a and 7b show further views of the proctoscope.

[0109] For better comprehensibility, the proctoscope 1 already shown in Figure 6 is shown in a side view in Figure 7a and in a further perspective view in Figure 7b. All elements shown in Figures 7a and 7b have already been described in detail in previous figures, so a repetition is not necessary here. To perform a surgical procedure, the obturator 19 is subsequently removed from the surgical tube 9 arranged and fixed in the fastening ring 2, which is shown in Figure 8 by the third arrow 26. A redundant explanation of the known elements shown in Figure 8 is omitted.

[0110] The surgical window 13 of the surgical tube 9 is now exposed, and the surgeon can perform a surgical procedure in the area of ​​the human rectum. This can be performed at the location described as the 12 o'clock position, since the surgical window 13 is oriented as shown in Figures 6 to 8.

[0111] To select a different direction or position for the surgical window 13, the obturator 19 is reinserted into the surgical tube 9, as shown by the fourth arrow 27 in Figure 9. The second alignment mark 23 of the obturator 19 is brought into alignment with the first alignment mark 16 of the surgical tube 9.

[0112] This insertion of the obturator 19 into the surgical tube 9 completely closes the surgical window 13 in the surgical tube 9. This insertion is carried out in such a way that the first alignment mark 16 of the surgical tube 9 and the second alignment mark 23 of the obturator 19 are aligned.

[0113] When the obturator 19 is inserted into the surgical tube 9 and the surgical window 13 is thus closed, a safe rotation of the surgical tube 9 and thus of the surgical window 13 to different positions is possible.

[0114] To change the position of the surgical window 13, the unit, consisting of the surgical tube 9 with the inserted obturator 19, is rotated in the direction indicated by arrow 28 in Figure 10 and subsequently pulled out of the fastening ring 2, as indicated by arrow 29. This process corresponds to the release or opening of the bayonet lock, which is formed by the first locking element 8 (not shown in Figure 10) and the second locking element 17.

[0115] Subsequently, the surgical tube 9 with the obturator 19 inserted is rotated into a position where it is completely withdrawn from the fastening ring 2. In Figure 11, the arrow 30 shows the rotation process; in the selected illustration, the surgical tube 9 with the obturator 19 inserted is not shown completely withdrawn from the fastening ring 2. Rotating the surgical tube 9 in the anal canal must be avoided at all costs, as this could otherwise lead to tissue torsion.

[0116] In the example of Figure 11, the surgical window 13 is rotated to the 3 o'clock position. For this purpose, the first alignment mark 16 and the second alignment mark 23 are aligned with the 3 o'clock position mark 10 shown in Figure 11 with reference number 10.

[0117] To fix the surgical window 13 in this 3 o'clock position, the surgical tube 9 with the inserted obturator 19 is pushed into the fastening ring 2 and rotated, thereby closing the bayonet lock in the new 3 o'clock position. This process is a reversal of the procedure described in Figure 10 and is not shown separately.

[0118] In this manner, the other positions 10, 11 can also be reached or selected for the alignment of the operating window 13.

[0119] It is also intended that the part of the system that can be rotated in the mounting ring 2, i.e., the surgical tube 9, can be locked and thus fixed by turning it into, for example, seven positions. These positions correspond to the position marks 10 shown in Figure 1 at the positions 1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock, and 12 o'clock. Another position is the 12 o'clock mark on the mounting ring.

[0120] To perform a surgical procedure, the obturator 19 is subsequently removed from the surgical tube 9 arranged and fixed in the fastening ring 2, as shown in Figure 8 by the third arrow 26. This releases the surgical window at the newly selected position.

[0121] To remove the proctoscope 1, the obturator 19 is reinserted into the surgical tube 9, as shown by the fourth arrow 27 in Figure 9. The second alignment mark 23 of the obturator 19 is brought into alignment with the first alignment mark 16 of the surgical tube 9. This insertion of the obturator 19 into the surgical tube 9 completely closes the surgical window 13 in the surgical tube 9.

[0122] Subsequently, for example, the surgical tube 9 with the inserted obturator 19 is removed from the fastening ring 2 by opening the bayonet lock, as described in Figure 10. Subsequently, the surgical tube 9 with the inserted obturator 19 is completely pulled out of the fastening ring 2.

[0123] The fixation ring 2 is then released by cutting the skin sutures and removed from the area of ​​the human rectum.

[0124] Figure 12 shows the assembled proctoscope 1 and Figure 13 shows an enlargement of the area of ​​the radial fixation 18 on the surgical tube 9 and the further radial fixation 22 on the obturator 19, which area is surrounded by a ring in Figure 12.

[0125] Figure 12 shows the three-part proctoscope 1, already known from Figure 6, in its assembled form. The proctoscope 1 comprises the fastening ring 2, the surgical tube 9, and the obturator 19. In a region of the proctoscope 1 in Figure 12 surrounded by a ring, the radial fixation 18 of the surgical tube 9 and the further radial fixation 22 of the obturator 19 are shown.

[0126] Figure 13 shows that the additional radial fixation 22 is designed as a U-shaped elevation on the obturator 19, with arcuate locking elevations 32 arranged on opposite parallel outer legs 31 of the U-shaped additional radial fixation 22. Furthermore, Figure 13 shows that the radial fixation 18 is designed as a U-shaped notch in the surgical tube 9, with arcuate locking recesses 34 arranged on opposite parallel inner legs 33 of the radial fixation 18.

[0127] The curved locking protrusions 32 and the curved locking recesses 34 are designed to correspond to one another. They thus have complementary shapes and thus enable the curved locking protrusions 32 to engage the curved locking recesses 34 when the obturator 19 is inserted into the surgical tube 9, forming a positive connection between the obturator 19 and the surgical tube 9.

[0128] List of reference symbols

[0129] 1 proctoscope

[0130] 2 mounting rings

[0131] 3 first area fastening ring (cylindrical)

[0132] 4 second area mounting ring (flange)

[0133] 5 handle

[0134] 6 recessed grip

[0135] 7 mounting holes

[0136] 8 first locking elements

[0137] 9 Surgical tube

[0138] 10 position marks

[0139] 11 Pos itio nierh i lfe / 12 o'clock mark

[0140] 12 first end of surgical tube

[0141] 13 operating windows

[0142] 14 second end of surgical tube

[0143] 15 holes / pimples

[0144] 16 first alignment mark / thread fastening

[0145] 17 second locking element

[0146] 18 radial fixation on the surgical tube for obturator

[0147] 19 Obturator

[0148] 20 first end obturator

[0149] 21 second end obturator

[0150] 22 further radial fixation

[0151] 23 second alignment mark

[0152] 24 first arrow

[0153] 25 second arrow

[0154] 26 third arrow

[0155] 27 fourth arrow

[0156] 28 fifth arrow

[0157] 29 sixth arrow

[0158] 30 seventh arrow outer leg curved locking elevations inner leg curved locking recesses

Claims

Patent claims 1. A proctoscope (1) which is constructed in three parts and has, as a first part, a fastening ring (2) open on its opposite sides, with a first region (3) having an at least partially cylindrical shape or cylindrically conical shape, and a flange-like second region (4), characterized in that the fastening ring (2) is made of a transparent material, has a plurality of position marks (10), a positioning aid (11) in the form of a 12 o'clock mark, and a plurality of first locking elements (8), that a second part is an operating tube (9) which can be arranged in an inner diameter of the fastening ring (2), which has a second locking element (17) which can be positively connected and fixed to one of the first locking elements (8), which has a frustoconical or hemispherical, at least partially closed first end (12) and an operating window (13),which is a rectangular opening arranged substantially along a cylindrical wall of the surgical tube (9), that a third part is an obturator (19) which can be inserted into the surgical tube (9) and radially fixed, which has a first conical or hemispherical closed end (20) adapted to the first end (12) of the surgical tube (9) and which, when inserted into the surgical tube (9) and radially fixed, is arranged to completely close the surgical window (13), that at least one first alignment mark (16) with a thread attachment and a radial fixation (18) are arranged on a second end (14) of the surgical tube (9), and that a further radial fixation (22) is arranged on the obturator (19), which, when the obturator (19) is inserted into the surgical tube (9), is arranged to snap into a radial fixation (18) arranged on the surgical tube (9).

2. Proctoscope (1) according to claim 1, characterized in that the fastening ring (2) has a plurality of fastening holes (7) and a handle (5). Proctoscope (1) according to claim 1 or 2, characterized in that the further radial fixation (22) is U-shaped, with arcuate locking elevations (32) being arranged on opposite parallel outer limbs (31) of the U-shaped further radial fixation (22), that the radial fixation (18) is also U-shaped, with arcuate locking recesses (34) being arranged on opposite parallel inner limbs (33) of the radial fixation (18), and that the arcuate locking elevations (32) and the arcuate locking recesses (34) have corresponding, complementary shapes and thus engage with one another when the obturator (19) is inserted into the surgical tube (9). Proctoscope (1) according to one of claims 1 to 3, characterized in thatthat at the second end (14) of the surgical tube (9) along the circumference of the surgical tube (9) a plurality of holes or nubs (15) are arranged. A proctoscope (1) according to one of claims 1 to 4, characterized in that the obturator (19) has a second alignment mark (23) at a second end (21) and that a plurality of holes or nubs (15) are arranged along the circumference of the surgical tube (9). A method for using a proctoscope (1), wherein a three-part proctoscope (1) is provided, wherein a first part is a fastening ring (2) open on its opposite sides, having a first region (3) with an at least partially cylindrical shape or cylindrically conical shape, and a flange-like second region (4), and wherein the proctoscope (1) is insertable into a rectum of a patient, characterized in thatthat in order to insert the proctoscope (1), in a first step the fastening ring (2) is introduced into the rectum and fastened, that a second part, an operating tube (9), and a third part, an obturator (19), are provided, that in a second step the obturator (19) is introduced into the operating tube (9) and radially fixed thereto, that in a subsequent step the unit consisting of the operating tube (9) with the inserted obturator (19) in, the fastening ring (2) is inserted and locked thereto, that subsequently the obturator (19) is removed from the surgical tube (9) and thus a surgical window (13) in the surgical tube (9) is released, which enables a surgical intervention in the area of ​​the rectum, that to remove the proctoscope (1) the obturator (19) is inserted into the surgical tube (9) and locked thereto, that the unit consisting of the surgical tube (9) with the inserted obturator (19) is released from the fastening ring (2) and removed, and that the fastening ring (2) is released and removed, wherein for locking the surgical tube (9) with the obturator (19) inserted into the fastening ring (2), several first locking elements (8) are provided in the fastening ring (2) and a second locking element (17) is provided on the surgical tube (9),wherein each of the first locking elements (8) can be positively connected and fixed to the second locking element (17), and wherein, for the positive connection of the obturator (19) inserted into the surgical tube (9) to the surgical tube (9), a radial fixation (18) is provided on the surgical tube (9) and a further radial fixation (22) is provided on the obturator (19), which engage with each other to enable the positive connection. Method according to claim 6, characterized in that the unit comprising the surgical tube (9) with the inserted obturator (19) is inserted into the fastening ring (2) and rotated prior to locking with the fastening ring (2) until the position of a first alignment mark (16) of the surgical tube (9) has been aligned with the position of a position mark (10) or a positioning aid (11) provided on the fastening ring (2).wherein the surgical window (13) of the surgical tube (9) is aligned in the direction indicated by the position mark (10) or the positioning aid (11). Method according to claim 6 or 7, characterized in that the fastening ring (2) is provided with six position marks (10) and a positioning aid (11), wherein the position marks (10) determine the alignment 1 o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock and the positioning aid (11) has the orientation 12 o'clock. Method according to one of claims 6 to 8, characterized in that the further radial fixation (22) is provided in a U-shape, wherein arcuate locking elevations (32) are provided on opposite parallel outer legs (31) of the U-shaped further radial fixation (22), that the radial fixation (18) is likewise provided in a U-shape, wherein arcuate locking recesses (34) are provided on opposite parallel inner legs (33) of the radial fixation (18), and wherein the arcuate locking elevations (32) and the arcuate locking recesses (34) have corresponding, complementary shapes and thus engage with one another when the obturator (19) is inserted into the surgical tube (9) and produce a positive connection.Method according to one of claims 6 to 9, characterized in that the fastening ring (2) is provided consisting of a transparent material.