Proctoscope

Abstract

The present invention relates to a rectoscope (1,1') comprising a body (2,2'), a handle (3,3') extending from the body (2,2'), an elongate element (4,4') having a front end (10) and a rear end (13), said rear end being attached to the body (2,2') and open such that the interior of the elongate element (4,4') is accessible via the rear end, said elongate element extending along a longitudinal axis L, at least one opening (5;5') formed in the elongate element between the front and rear ends and / or a transparent portion formed in the elongate element between the front and rear ends, and reference markings (9a,9b,9c) arranged along the at least one opening and / or the transparent portion, the reference markings (9a,9b,9c) being readable via the open rear end of the elongate element. The rectoscope further comprises a positioning device for supporting the rectoscope (1,1') in an intended position relative to the treatment area, said positioning device comprising an elongated positioning device (7,7') with a front end contact surface (8), the elongated positioning device (7,7') being movably arranged within the body (2,2') along an axis substantially parallel to the axis L and extending from the body (2,2') in the same direction as the elongated elements (4,4') from the body (2,2'), and a locking means (71,71) configured to fix the elongated positioning device (7,7') in a selected position, the front end contact surface (8) being adapted to abut against the patient's skin to maintain and support the rectoscope in a position along the longitudinal axis along which the treatment area is located in an intended position relative to the reference markings (9a,9b,9c).

Description

[Technical field]

[0001] The present invention relates to a rectoscope. [Background technology]

[0002] Up to 25% of the population over the age of 50 suffer from hemorrhoids. Hemorrhoids are painful and can cause serious problems for those affected.

[0003] There are several methods of treatment, all of which are associated with varying degrees of complications. One of the most used modern techniques involves the occlusion of the arterial supply to the anus with a ligature, after which the mucosa is elevated and fixed in the elevated position by 4-5 sutures.

[0004] An alternative method is by using a device for the treatment of hemorrhoids disclosed in EP 2163211. The device disclosed is intended for surgical stapling, which results in the desired treatment of hemorrhoids by cutting the mucosa and stapling it back together, thereby lifting the mucosa 2-3 cm. The treatment is effective, but is associated with severe complications such as postoperative pain, sepsis, and even death. It is costly due to the need for anesthesia and the cost of the device.

[0005] The various known methods for treating hemorrhoids all have different drawbacks, and as a result there is a need for improved technical solutions that make it possible to reduce operation times, treatment costs and improve treatment results. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] European Patent No. 2163211 Summary of the Invention

[0007] The present invention relates to a rectoscope making it possible to alleviate at least to some extent the problems defined above.

[0008] The rectal speculum is The main body, A handle extending from the main body; an elongate element having a front end and a rear end, the rear end being attached to the body and open such that an interior of the elongate element is accessible through the rear end, the elongate element extending along a longitudinal axis L; at least one aperture formed in the elongate element between the front and rear ends and / or a transparent portion formed in the elongate element between the front and rear ends; fiducial markings disposed along the at least one aperture and / or transparent portion, the fiducial markings being readable through the open rear end of the elongate element; The rectal speculum comprises: and a positioning device for supporting the rectoscope in an intended position relative to the treatment area, the positioning device comprising: an elongate alignment device with a front end contact surface, the elongate alignment device being movably disposed within the body along an axis substantially parallel to the axis L and extending from the body in the same direction as the elongate element from the body; a locking means configured to lock the elongate alignment device in a selected position; Equipped with the front end contact surface is adapted to abut the patient's skin to maintain and support the rectoscope in a position along the longitudinal axis where the treatment area is located at an intended location relative to the fiducial markings; It is characterized by:

[0009] To ensure the desired outcome of a surgical treatment of hemorrhoids, it is essential to establish the exact location of the area requiring treatment. The rectoscope of the present invention is adapted to be introduced into the rectum of a patient to facilitate determining the location of the treatment area within the rectum prior to surgical treatment of hemorrhoids, and to maintain the rectoscope in the desired position during surgery.

[0010] The at least one opening and / or transparent portion allows the location of the prolapsed anal mucosa to be detected and the rectoscope to be positioned such that the prolapsed anal mucosa is located in an intended position relative to fiducial markings on the rectoscope. Once the location of the area requiring treatment has been determined, the position of the rectoscope along axis L is adjusted such that the area requiring treatment is located in an intended position along the elongate element and the positioning device is positioned to support and maintain the rectoscope in a desired position along axis L with the front end contact surface abutting the patient's skin somewhere in the area surrounding the rectum. Additionally, the handle facilitates introduction and angular positioning of the device. The elongate positioning device may be embodied in several different ways, such as, for example, a screw or an elongate rod that can be fixed in a desired position.

[0011] In one embodiment of the rectoscope, the fiducial markings are adapted to be located adjacent to the intended treatment area or a reference location such as the linea dentata, and the elongated positioning device is locked in position such that the end contact surface abuts the patient's skin. The dentate line is a very good reference location since surgery is preferably performed inside the dentate line where there is less risk that the surgical procedure will cause significant pain to the patient.

[0012] In one embodiment of the rectoscope, at least one opening and / or transparent portion is elongated and extends substantially parallel to the axis L. An elongated opening and / or transparent portion can provide visual access to a larger portion of the rectum and facilitate determination of the area requiring treatment.

[0013] In one embodiment of the rectoscope, the elongate element is formed from a transparent material. This embodiment is advantageous because the transparent elongate element allows for visual inspection of the entire area of ​​the rectum surrounding the transparent elongate element.

[0014] One embodiment of the rectoscope further comprises means for illuminating the interior of the elongated element to facilitate visibility during positioning of the rectoscope along the axis L.

[0015] In one embodiment of the rectoscope, the fiducial markings extend substantially parallel to the axis L along at least one opening and / or transparent portion and are readable through the open rear end.

[0016] In one embodiment of the rectoscope, the front end contact surface is substantially flat and oriented substantially perpendicular to the elongated positioning device to provide a comfortable, reassuring support against the patient's skin.

[0017] In one embodiment of the rectoscope, the elongated position adjustment device is adjustable between an extended end position and a retracted end position.

[0018] In one embodiment of the rectal scope, the elongated positioning device is configured to be movable between a first angular position in which the elongated positioning device can slide within the device body and a second angular position in which a locking means secures the elongated positioning device in a desired position.

[0019] In one embodiment of the rectoscope, the elongated positioning device and locking means have a male / female configuration for locking the elongated positioning device in a desired position.

[0020] In one embodiment of the rectal speculum, the long positioning device and device body are provided with corresponding treads such that the long positioning device is moved by rotating the long positioning device, and the locking means is embodied as a high friction material disposed on the treads to secure the long positioning device in a desired position.

[0021] In one embodiment of the rectoscope, the elongate element has an open leading end, and the rectoscope further comprises an elongate core member removably mounted within the elongate element, the elongate core element having a rounded leading end for ease of introduction into the patient's rectum.

[0022] In one embodiment of the rectoscope, the elongated element is removably attached to the device body and is replaceable with a rectoscope treatment element having a similar size and shape as the elongated element. This embodiment is advantageous because the desired position of the rectoscope is determined with the elongated element attached to the body and the elongated positioning device locked in the selected position. The positioning device ensures that the rectoscope is positioned in the same position along axis L, i.e., with the front end contact surface abutting the patient's skin, so that the rectoscope is removed from the rectum and the elongated element is replaced with the treatment element and easily inserted into the rectum at the same position.

[0023] During the use of the rectoscope, the following steps are carried out: - inserting an elongate element into the patient's rectum to a position where the intended treatment area is located at an intended position relative to the fiducial markings; - adjusting the position of the elongated positioning device (7) so that the front end contact surface (8) abuts against the patient's skin to maintain and support the rectoscope in the desired position; - fixing the elongated position adjustment device (7) in the selected position by means of a locking means; will be carried out.

[0024] The rectoscope is more precisely positioned during the entire procedure which facilitates the procedure and improves the final outcome of the procedure.

[0025] Furthermore, the following further steps are performed: - removing the elongate element from the rectum; - removing the elongated element from the body and attaching a rectoscope treatment element (20) having a similar size and shape to the body; - inserting the rectoscope treatment element into the patient's rectum until the front end contact surface (8) abuts the patient's skin to maintain and support the rectoscope in the desired position; may be performed.

[0026] These further steps are advantageous since the positioning of the rectoscope can be performed with the elongated element that provides visible access to the intended treatment area. When the rectoscope is in the intended position, the positioning device is locked in the desired position and the rectoscope is removed from the rectum. The elongated element of the rectoscope is then replaced with the treatment element that is used to perform the operation and is inserted in a position with its front end contact surface abutting the patient's skin to maintain and support the rectoscope in the desired position. The possibility to set the position with the elongated element that provides good visibility of the treatment area ensures a good outcome from the operation and greatly facilitates the process.

[0027] In an alternative use of the rectoscope according to the invention, the elongated positioning device is provided with an indexing scale extending along the elongated positioning device. Instead of replacing the elongated element with the treatment element when the desired position of the support device, i.e. the elongated positioning device and the locking means, is determined, a reference value is determined from the indexing scale. The reference value is then used to calibrate the support device, i.e. the elongated positioning device and the locking means, of a corresponding substantially identical rectoscope used to perform the operation. This arrangement may be advantageous to reduce the risk of contamination, since one rectoscope is used to determine the position of the examination and treatment area, while a separate disinfected rectoscope is used to perform the operation. If separate rectoscopes are used for the operation, it is essential that the two rectoscopes have the same size and dimensions, so that the operation is performed in the intended treatment area.

[0028] The above, as well as further objects, features and advantages associated with the present invention, will become apparent upon consideration of the following illustrative, non-limiting detailed disclosure of preferred embodiments of the invention, with reference to the accompanying drawings. [Brief description of the drawings]

[0029] [Figure 1] 1 shows a perspective view of a first embodiment of a rectoscope according to the present invention; [Diagram 2] 1 shows a perspective view of a second embodiment of a rectoscope according to the present invention; [Diagram 3]3 shows a perspective view of the rectoscope of FIG. 2. [Figure 4] 1 shows a perspective view of a rectoscope with a position adjustment device in a first configuration. [Diagram 5] 1 shows a perspective view of a rectoscope with a position adjustment device in a second configuration. [Figure 6] 1 shows another configuration of a rectoscope in perspective view. [Figure 7] 1 shows a schematic exploded view of selected components of a rectoscope. [Figure 8] 7 illustrates selected portions of the rectoscope of FIG. 6 after introduction of a needle. [Figure 9] 2 shows a second embodiment of a positioning device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] All figures are schematic, not necessarily to scale, and generally show only selected parts necessary to understand the invention; other parts may be omitted or may only be suggested.

[0031] The present invention, as mentioned above, relates to a rectoscope intended to facilitate the treatment of hemorrhoids.

[0032] The rectoscope comprises several different components which will be described in detail with reference to the accompanying drawings.

[0033] A first embodiment of a rectoscope 1 according to the present invention is shown in Figure 1 and comprises a body 2 arranged to support different components of the rectoscope 1. The body 2 is shaped as an annular member having a generally circular passageway 6 extending therethrough. The circular passageway 6 is disposed in a plane transverse to the longitudinal axis L of the rectoscope.

[0034] The rectoscope further comprises a curved handle 3 extending from the body 2 substantially radially from the longitudinal axis L. However, the configuration of the handle can be modified in different ways to adapt the rectoscope to patients of different sizes / dimensions. The handle is intended to facilitate manipulation of the rectoscope.

[0035] One essential part of the rectoscope is an elongate element 4 extending from the body 2 along a longitudinal axis L. The elongate element 4 includes rounded front and rear ends 10 and 11 removably attached to the body. The rear end is open so that the interior of the elongate element is accessible through a passage in the rear end and the body. The elongate element 5 has a substantially circular cross-sectional shape with substantially the same radius along the entire elongate element. At least one opening 5 is formed in the elongate element between the front and rear ends and / or a transparent portion is formed in the elongate element between the front and rear ends, allowing visual inspection of the anal mucosa and hemorrhoids through the passage formed in the open rear end and body of the elongate member when the elongate element is placed in the rectum of a patient. In an alternative embodiment, the entire elongate element is made of a transparent material to further improve the possibility of visually inspecting the tissue. This embodiment can also be used in combination with at least one opening in the elongate element.

[0036] The elongate element is provided with reference markings 9a, 9b, 9c arranged along at least one aperture and / or transparent portion. The reference markings may for example be one or more lines or scales arranged along at least one aperture or on the transparent portion such that the reference markings are readable through the open rear end of the elongate element.

[0037] The rectoscope further comprises a positioning device for supporting the rectoscope (1, 1') in an intended position relative to the identified treatment area. The embodiment of the positioning device shown in figures 1 to 8 comprises an elongated positioning device 7 extending from the body substantially parallel to the elongated element 4, in the same direction as the elongated element 4, i.e. parallel to the axis L. The elongated positioning device in the illustrated embodiment is designed as a screw. The screw has an external thread and is arranged in a corresponding hole with an internal tread of the device body 2, such that by rotating the screw, the position along the axis L is adjusted between a forward position and a rearward position. The positioning device comprises a substantially flat front end contact surface 8 arranged substantially perpendicular to the longitudinal axis L. The flat front end contact surface 8 is adapted to abut against the patient's skin in the area surrounding the patient's rectum. The positioning device further comprises a locking means arranged to fix the elongated positioning device in a selected position. In this embodiment, the locking means is embodied as a surface structure or layer of high friction material on the respective tread in order to maintain the elongated positioning device, i.e. the screw, in the desired position.

[0038] Another embodiment of the positioning device is shown in Fig. 9. In this embodiment, the long positioning device 7' is embodied as an elongated rod slidably arranged in a corresponding passage in the body 2'. The elongated rod is rotatable about its longitudinal axis, as indicated by the arrow in Fig. 9, between a first angular position in which the long positioning device can slide in the device body 2', and a second angular position in which the locking means 71, 72 fix the long positioning device in a desired axial position. The locking means have a male / female configuration with a notch 71 arranged along the long positioning device 7' and a corresponding locking element 72 arranged in the body 2'.

[0039] The elongated positioning device is also provided with an indexing scale extending along the elongated positioning device 7'. The indexing scale allows a reference value representing a desired position of the rectoscope to be determined.

[0040] A further alternative is to provide a resilient member at the rear end of the elongated position adjustment device that can be bent outwardly from the longitudinal direction and locked, for example, in a clamp, so that the elongated position adjustment device can be locked in a desired position.

[0041] Before the hemorrhoidal surgical procedure is started, the rectoscope 1 according to the invention, i.e. the elongated element 4, is placed in the rectum of the patient. The elongated positioning device is adjusted along the axis L such that the elongated element is maintained in position along the axis L, where the hemorrhoid is positioned in the intended position along the elongated element 4. Once the elongated positioning device is locked in the desired position to maintain the rectoscope in the desired position along the axis L, the positioning device ensures that the rectoscope returns to the determined desired position, so that it can be removed from the rectum and easily returned to the desired set position. The positioning device prevents the elongated element from being introduced too far forward into the patient's rectum.

[0042] The fiducial markings on the rectoscope can be embodied in a variety of ways, but in one preferred embodiment, one fiducial marking, designated in the figures by reference number 9c, is integrated to be located along the dentate line in the patient's rectum. The location of this fiducial marking, fiducial 9c, is such that when fiducial marking 9c is aligned with the dentate line further back along the elongate element, the treatment area is located inside the rectum where humans have limited sensation of pain.

[0043] To further improve visibility, the positioning device may comprise means for illuminating the interior of the elongate element. The means for illuminating the interior may have different configurations, but preferably comprise one or more diodes or lamps arranged in the body such that the interior of the elongate element is illuminated. The one or more diodes or lamps are powered by a battery arranged in the body or by an external power source, i.e. electricity, connected to the body. A further alternative is to use an external light source and direct the light to the desired location by optical fibers.

[0044] A second embodiment of a rectoscope 1' is shown in two different configurations in Figures 2 and 3. In this embodiment, the body 2 is substantially the same as the previous embodiment, but the elongate element 4' is shaped like a tube with an open front end 10. In this embodiment, the at least one opening is formed as an elongate slot 5' extending from the rear end 11 to the open front end. The rectoscope further comprises an elongate core member 12 removably mounted within the tube-shaped elongate member to close the at least one opening 5'. The core member 12 has a length corresponding to the length of the elongate element such that the rounded front end of the core member brings the rounded front end of the elongate element to close the front end.

[0045] When the rectoscope is introduced into the patient's rectum, the core member 12 is removed through the open rear end of the elongate element and the passage in the body to open the at least one opening 5' for improved visibility. This embodiment is advantageous because the at least one opening is closed by a smooth surface, facilitating the introduction of the elongate element into the patient. This embodiment is particularly advantageous when the at least one opening has a substantial size.

[0046] Additionally, in this embodiment, the elongate element may be made of a transparent material, or the entire elongate element may be formed with transparent portions, to further facilitate visual inspection of the anal mucosa and hemorrhoids.

[0047] In both embodiments of the rectoscope, the elongate element is preferably removably attached to the body. Once the dentate line is aligned with the reference markings and the elongate positioning device 7 is located in the desired position along the longitudinal axis, the rectoscope is removed from the rectum and the elongate element is replaced by the treatment element 20. The treatment element comprises a tubular shaped element 21 designed to fit into the body 2 in the same position as the elongate element and has substantially the same size and dimensions as the elongate element. In the embodiment shown, the rear end of the tubular shaped element is flared outwards to form a connection socket 2' adapted to be attached to the body.

[0048] The treatment element 20 is intended for the treatment of hemorrhoids and comprises anal mucosa support devices 22, 22a, 22b, 22c removably arranged in a tubular-shaped element 21, whereby said support devices are exposed in openings 23 of the tubular-shaped element. The treatment element can also be designed with two or more similar openings arranged around the circumference of the tubular-shaped element, with one anal mucosa support device arranged in each opening.

[0049] An elongated tubular shaped element 21 constitutes the outer casing of the treatment element 20. The tubular shaped element 21 comprises a rounded front end 24 adapted to be placed in the rectum of a patient. The tubular shaped element 21 further comprises an open rear end 25 adapted to be placed in a central open passage in the body 2 such that the interior of the tubular shaped element is accessible via the passage in the body 2. The tubular shaped element 21 is substantially straight and extends along a longitudinal axis L. The tubular shaped element can be made in different lengths, the cross-sectional shape of the tubular shaped element transverse to the axis L being substantially circular to facilitate the insertion of the device when the treatment is started. Alternative cross-sectional shapes may also be oval, triangular, rectangular, pentagonal or hexagonal with rounded corners, etc. The tubular shaped element is preferably made of a plastic material.

[0050] The angular position of the opening 23 of the tubular shaped element about the axis L corresponds to the angular position of the at least one opening of the elongate element when the elongate element and the treatment element are attached to the device body in the correct position.

[0051] The illustrated embodiment of the anal mucosal support device 22 comprises a first elongate portion 22a, an intermediate elongate portion 22b, and a second elongate portion 22c arranged to extend substantially parallel to an axis L. The first elongate portion, the intermediate elongate portion, and the second elongate portion are disposed adjacent to one another and removably disposed within the tubular shaped element.

[0052] The anal mucosa support device comprises at least two cavities 26 for the anal mucosa arranged at positions along the same longitudinal axis L as the intended treatment areas corresponding to the positions of the fiducial markings of the elongate elements, whereby the positions defined by the positioning device ensure that the identified treatment areas are accurately positioned when the treatment elements are inserted to begin the procedure.

[0053] The treatment area, and thus also the two cavities 26, are preferably arranged so that there is a distance along the axis L between the dentate line and the outer edge of the treatment area in the range of 10 to 15 mm, i.e. the edges of the cavities are arranged close to the dentate line.

[0054] The treatment element reaches the intended desired location when it is advanced into the patient's rectum to a position where the leading end contact surface abuts the patient's skin.

[0055] The cavities 26 are disposed substantially centrally of the opening 23 of the tubular-shaped element along the longitudinal axis L. Each cavity 26 has an open side facing the opening 23 of the tubular-shaped element to allow the anal mucosa to enter each cavity.

[0056] The first elongated portion 22a, the intermediate elongated portion 22b, and the second elongated portion 22c are designed to be disposed adjacent to one another substantially in the center of the opening 23, and each of the cavities 26 is disposed along the interface between the first elongated portion 22a, the intermediate elongated portion 22b, and the second elongated portion 22c such that the cavity is formed by the cavities of the first elongated portion, the intermediate elongated portion, and the adjacent second elongated portion, i.e., such that the cavity is formed by three elongated portions. Furthermore, needle passages 27 are formed along the interface between the first portion and the intermediate portion, and between the intermediate portion and the second portion. The illustrated embodiment of the rectoscope comprises four needle passages 27, i.e., one needle passage 27 between each cavity 26 of the anal mucosa support device 22. The needle passageway 27 is opened when the first elongate portion, the intermediate elongate portion, and the second elongate portion are separated from one another to release the needle 50 or suture, staple or fastening means extending through the needle passageway 27.

[0057] The needle passages 27 constitute needle guiding structures formed in the long tubular element and the anal mucosa support device such that the needles 50 are guided during their movement in the tubular element from a withdrawal position where the needles 50 are located outside the opening 23 of the long tubular element 21, through the cavity 26 of the anal mucosa support device 22, to a position where the needles extend across the opening 23 of the tubular element. Each needle passage 27 has a size and shape according to the cross-sectional dimensions and shape of the needles 50 so that the needles can easily pass through each needle passage 27 as they are moved from the retracted position to the withdrawal position. Preferably, the side of the needle passage facing the rear end of the device is slightly widened to guide the needles to the center of the needle passage. In the illustrated embodiment, the two needles are formed as a single element by a connecting structure 52 at the rear end of the needles such that the two needles 50 are moved simultaneously in adjacent needle passages. The connecting structure is preferably slightly elastic so that the needles can also move independently of each other.

[0058] Each cavity 26 of the anal mucosa support device 20 comprises a bottom structure, and the radial distance from the axis L between the center of the needle passage and the bottom structure is 2-12 mm. To ensure that the anal mucosa is correctly positioned in the cavity 26 of the anal mucosa support device, the bottom structure of each cavity comprises at least one opening in each cavity, said opening being connected to some kind of means capable of providing a pressure lower than the ambient pressure, such as a manual or electric pump or an externally located suction source, so that the anal mucosa is sucked into the cavity 26.

[0059] The anal mucosa support device 22 is removably placed in the tubular-shaped element 21 and maintained in its intended position therein by a removable locking element. The locking element is shaped like an elongated plate with a length, length along axis L, and width corresponding to the internal dimensions of the elongated tubular-shaped element. The positioning and fixing of the locking element in the tubular-shaped element is performed by guide rails 32 arranged along the inner peripheral wall of the tubular-shaped element on both sides of the opening of the tubular-shaped element so that the locking element can slide parallel to the longitudinal axis L. The first elongated element, the intermediate elongated element, and the second elongated element of the anal mucosa support are fitted into recesses on the side of the locking element facing the opening 23 of the tubular-shaped element so that the first element, the intermediate element, and the second element are maintained in their intended position. The locking element is placed in the tubular-shaped element to press the anal mucosa support device into its intended position and to maintain the anal mucosa support device in its intended position with a cavity exposed in the opening of the tubular-shaped element.

[0060] Although the above description of the treatment element 20 describes only one configuration having one opening 23 in the tubular shaped element 21, one anal mucosa support device 22, and one locking element 30, preferably, the treatment element 20 is designed to have two, or three, or up to six similar corresponding substantially identical configurations.

[0061] The treatment element 20 is introduced into the patient's rectum to allow the surgeon to surgically treat the hemorrhoids. When the rectoscope is in its intended position, the prolapsed anal mucosa is placed in a cavity 26 in the anal mucosa support device. The needle guide structure 27 formed on the elongated tubular element and on the anal mucosa support device guides the needle or needles 50 during the movement in the tubular element 21 from the withdrawn starting position through the cavities 26, i.e. through the anal mucosa located in the cavities, to a position where the needles 50 extend across the openings 23 in the tubular element 21 and through the anal mucosa located in the different cavities 26 such that a fold is created in the anal mucosa.

[0062] The needles 50 are used to introduce the sutures, staples or fastening means through different folds of the anal mucosa. Various alternative means of entering the sutures, staples or fastening means can be used.

[0063] Either the suture, staple or fastening means is introduced with the needle, or the needle is first moved from a retracted position to a withdrawal position where the needle tip is secured within a corresponding docking element at the end of the suture, staple or fastening means disposed within the front end of the treatment element. As the needle 50 is retracted from the withdrawal position, the suture, staple or fastening means is introduced into the anal mucosa and the suture, staple or fastening means is withdrawn through the anal mucosa.

[0064] Once the sutures, staples or fastening means are correctly positioned, the removable locking elements are removed and the anal mucosa support devices 22a, 22b, 22c are released from the locked position, thereby allowing them to be removed from the openings 23 via the open rear ends 25 to remove the anal mucosa and the sutures, staples or fastening means from the treatment elements. This is essential to allow removal of the treatment elements from the rectum after the sutures, staples or fastening means have been positioned to extend through the anal mucosa to allow for the desired tightening of the sutures, staples or fastening means to permanently secure the anal mucosa in the elevated position.

[0065] The needle guide structure and anal mucosa support device facilitate the surgical procedure by directing the needles 50, and ultimately the sutures, staples or fastening means, through the intended areas of the anal mucosa located in each cavity 26 so that the desired results are achieved.

[0066] In the case of severe hemorrhoid problems, more lifting of the rectal mucosa is required, which allows the distance between the fiducial markings to be increased, and thus the number of cavities in the anal mucosa support device to be increased, which allows more creases to be made on the anal mucosa, resulting in a significantly improved lifting effect.

[0067] The treatment element 20 further comprises one closure element 40 for each opening 23 of the tubular-shaped element 21. The closure elements 40 have a shape corresponding to the cross-sectional shape of the tubular-shaped element to provide a smooth profile of the treatment element and a length corresponding to the length of the opening 23 to completely close the opening when placed in the device. The closure elements are removably placed in the tubular-shaped element to close the opening of the tubular-shaped element to facilitate the insertion of the device into the rectum of the patient. When the device is in the desired position in the rectum, the closure elements, which extend all the way to the rear end, are removed through the rear end of the tubular-shaped element to expose the opening of the tubular-shaped element and allow the anal mucosa to enter the cavity. The closure elements 40 are arranged to slide in a substantially linear recess formed along the long side of the opening of the tubular-shaped element substantially parallel to the longitudinal axis L.

[0068] When the rectoscope is mounted in the intended position in the patient's rectum and the closure element is removed, the open rear end of the tubular-shaped element 12 is closed by a sealing plug 54. The sealing plug 54 is shown diagrammatically and is designed to close and seal the open rear end and the passage of the device body 2 so that a pump means or suction means can be connected to the interior of the tubular-shaped element 21 via a connection in said sealing plug 54. The sealing plug can also be provided with an elastic tube extending from it to facilitate the connection to the pump means or suction means. Alternative embodiments are also possible for making the desired connection of the pump means or suction means to the interior of the tubular-shaped element. For example, the pump means or suction means can be connected to the interior of the rectoscope via a connection arranged in the device body 2 or in the handle 3 and a channel integrated in the device and connected to the interior of the tubular-shaped element 21. When the pump means or suction means, not shown, are activated, the pressure in the tubular-shaped element 21 is reduced and the anal mucosa is sucked into the cavity.

[0069] Once the anal mucosa is in the desired position within the cavity 26, the needle 50 is pushed from the retracted position through the needle passageway 27, across the cavity 26 and the anal mucosa located therein, to the side opposite the opening 23 of the tubular shaped element 21.

[0070] To ensure that the anal mucosa is positioned in the cavity as intended, the open rear end 25 is sealed by a plug 54 with a shape and dimensions corresponding to the open rear end. In a preferred embodiment of the plug 54, an elastic membrane 55 is positioned to close the opening of the plug. The elastic membrane 55 is visible from the outside of the device so that the surgeon or operator can monitor that the desired reduced pressure in the treatment element has been established and the anal mucosa has been properly aspirated into the cavity. The elastic membrane may also be transparent to allow viewing inside the rectoscope when the plug is positioned to close the open rear end 25. Other embodiments may also provide a visual indication that the desired low pressure is reached in the rectoscope, such as a small button resiliently supported in the device, causing the button to retract from its starting position as the low pressure exceeds the force from the spring when the desired low pressure is achieved.

[0071] Various types of suture wires, stamps, or fixation devices can be used in combination with a rectoscope, and once the needle and suture, staple or fixation means are positioned to extend through the anal mucosa, the needle is removed and the suture, staple or fixation means is tightened and permanently secured so that the desired elevation of the prolapsed anal mucosa is achieved.

[0072] The treatment element can be adapted for use in combination with different alternatives for fixing the anal mucosa in a raised position. For example, a suture can be placed inside the tubular shaped element in the front end of the device before the treatment is started. A front stop element is permanently fixed to one end of the suture tread, and a suture docking means, for example a loop or a male / female fitting, is placed on the opposite end. The docking means is placed in the intended forward position of the needle tip. When the treatment element 20 is in the desired position in the patient's rectum, the needle 50 is moved from the retracted position through the cavity to the docking means, where the needle tip connects to the docking means and the needle is connected to the docking means. The needle together with the suture is then retracted to a position where the front stop element abuts the front fold of the anal mucosa. The needle 50, the sealing plug 54, the locking element and the anal mucosa support device 20 are then removed, releasing the tread and the anal mucosa from the anal mucosa support device. To achieve the desired lifting of the anal mucosa, the rear stop element is pushed forward along the suture, folding the anal mucosa toward the front stop element. The rear stop element and suture tread are provided with corresponding fixation structures that either prevent the rear stop element from moving rearward along the suture, or are permanently fixed in a desired position, for example by a knot. Once the needle and needle sleeve are removed from the tread, the rear stop element is placed over the suture.

[0073] A very simple and reliable embodiment based on this general concept includes a long length of suture that is placed within the treatment element before surgery begins. One end of the suture is provided with a docking element that is placed at the needle tip position at the front end of the opening 23. When the needle is introduced, the needle tip is connected to the docking element and the suture is introduced through the anal mucosa as the needle is retracted. The length of the suture is sufficient to allow both ends of the suture to extend completely through the open end of the device so that the surgeon can secure the suture ends with one or more knots and lift the anal mucosa.

[0074] This embodiment is also very advantageous in combination with the embodiment of the rectoscope with two parallel needles 50, for example as shown in Fig. 6, since a single suture can be placed at the front end of the device with a docking means with one end arranged at the front end of one needle and with a similar docking means with the second end of the suture arranged at the front end of the other needle. When the two needles are docked in the corresponding docking means, both ends of the suture are drawn through the folds of the anal mucosa so that both ends extend from the rear end of the rectoscope. After the sutures have been tightened and the desired lifting of the anal mucosa has been achieved, the two ends can be fixed by one or more reliable knots.

[0075] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description is to be considered as exemplary or exemplary and not restrictive, and the invention is not limited to the disclosed embodiments. As will be appreciated by those skilled in the art, many modifications, variations and changes are possible within the scope defined by the appended claims.

[0076] In addition, variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the term "comprising" does not exclude other elements, and the indefinite articles "a" or "an" do not exclude a plurality. The mere fact that certain features are recited in mutually different dependent claims does not indicate that a combination of these features cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope of the claims.

Claims

1. A main body (2, 2'), A handle (3, 3') extending from the main body (2, 2'); an elongate element (4, 4') having a front end (10) and a rear end (13), said rear end being attached to said body (2, 2') and open such that the interior of said elongate element (4, 4') is accessible via said rear end, said elongate element extending along a longitudinal axis L; at least one opening (5; 5') formed in the elongate element between the front end and the rear end and / or a transparent portion formed in the elongate element between the front end and the rear end; - fiducial markings (9a, 9b, 9c) arranged along the at least one aperture and / or transparent portion, the fiducial markings (9a, 9b, 9c) being readable through the open rear end of the elongate element; A rectal scope (1, 1') comprising: The present invention further comprises a positioning device for supporting the rectoscope (1, 1') in an intended position relative to the treatment area, the positioning device comprising: an elongate position adjustment device (7, 7') with a front end contact surface (8), the elongate position adjustment device (7, 7') being movably arranged in the body (2, 2') along an axis substantially parallel to the axis L and extending from the body (2, 2') in the same direction as the elongate elements (4, 4') from the body (2, 2'); locking means (71, 71) adapted to fix the longitudinal position adjustment device (7, 7') in a selected position; Equipped with the front end contact surface (8) is adapted to abut against the skin of a patient to maintain and support the rectoscope in a position along the longitudinal axis L such that the treatment area is located in the intended position relative to the fiducial markings (9a, 9b, 9c); A rectoscope (1, 1').

2. 2. The rectoscope of claim 1, wherein the reference markings (9a, 9b, 9c) are adapted to be positioned adjacent to a reference location such as the intended treatment area or a dentate line, and the elongated position adjustment device is locked in a position such that the front end contact surface abuts against the patient's skin.

3. 3. A rectoscope according to claim 1 or 2, characterized in that the at least one opening (5, 5') and / or the transparent portion are elongated and extend substantially parallel to the axis L.

4. A rectoscope according to any one of claims 1 to 3, characterized in that the elongate element is made of a transparent material.

5. 5. A rectoscope according to any one of claims 1 to 4, further comprising means for illuminating the interior of the elongated element.

6. 6. A rectoscope according to claim 1, characterized in that the reference markings (9a, 9b, 9c) extend along the at least one opening and / or transparent portion substantially parallel to the longitudinal axis L and are readable via the open rear end of the elongate element.

7. A rectal scope according to any one of claims 1 to 6, characterized in that the front end contact surface (8) is substantially flat and arranged substantially perpendicular to the longitudinal axis of the elongate position adjustment device (7, 7'), such that the front end contact surface (8) abuts against the patient's skin.

8. 8. A rectoscope according to any one of claims 1 to 7, characterized in that the longitudinal position adjustment device (7, 7') is adjustable between an extended end position and a retracted end position.

9. 9. The rectal speculum according to claim 8, characterized in that the long-length position adjustment device (7') is configured to be movable between a first angular position in which the long-length position adjustment device can slide within the device body and a second angular position in which the locking means (71, 72) fixes the long-length position adjustment device (7') in a desired position.

10. 10. The rectoscope of claim 9, wherein the elongated positioning device (7') and the locking means (71, 72) have a male / female configuration for locking the elongated positioning device in the desired position.

11. 9. The rectoscope according to claim 8, characterized in that the long position adjustment device (7) and the body (2) are provided with corresponding treads along which the long position adjustment device (7) is moved by rotating the long position adjustment device (7), and the locking means is embodied as a high friction material arranged on the treads to maintain the long position adjustment device in the desired position.

12. 12. A rectoscope according to any one of claims 1 to 11, characterized in that the elongated element (4') has an open front end, and the device further comprises an elongated core (12) member removably fitted within the elongated member.

13. The rectoscope according to any one of claims 1 to 12, characterized in that the elongated element (4, 4') is removably attached to the main body (2, 2') and is replaceable with a rectoscope treatment element (20) having a similar size and shape as the elongated element (4, 4').

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