Patent Description:
Up to <NUM>% of the population older than <NUM> years are suffering from hemorrhoids. Hemorrhoids can be painful and cause severe problems for the affected persons.

There are several methods of treatment, all associated with varying degrees of complications. One of the most used modern techniques implies occlusion of supplying arteries to the anus with a ligature; thereafter the mucosa is lifted through <NUM>-<NUM> stitches and secured in the lifted position.

One device intended to be used for the above described surgical treatment is disclosed in <CIT>. The elongated device is introduced in the rectum of the patient and makes it possible for the surgeon to ligate the arteries to the rectum by using a built-in ultrasonic device and access the anal mocusa via the space within the device and an opening formed in the surrounding wall of the device. To restore the anatomical position of the heamorrhoid the mucosa of the rectum needs to be lifted inwards by several stiches placed by the surgeon (mucopexy). By turning the device the mucosa is gradually accessible for further suturing. A total of <NUM> - <NUM> sutures are placed. After the suturing, a knot is placed to lift the rectum mucosa inwards and the hemorrhoid is repositioned to its anatomically normal position and the symptoms are reduced.

The disclosed device facilitates for the surgeon to perform the sewing but the stiches are placed by hand by the surgeon which is time consuming. Furthermore, sewing by hand results in variations in suture depth and length which will have an impact on the final result of the treatment. The disclosed device requires general anesthesia due to the space required when the stiches are placed by hand, which limits the treatment to patients who are able to receive general anesthesia and increases the treatment cost considerably.

An alternative device for treatment of hemorrhoids is disclosed in <CIT>. The disclosed device is intended for surgical stapling to generate the desired treatment of hemorrhoids by cutting away and staple the mocusa together again and thereby lifting the mocusa by <NUM> - <NUM>. The treatment is effective but is associated with severe complications like postoperative pain, sepsis and even death. The cost is high due to the necessity of anesthesia and the cost of the device.

Another alternative device is disclosed in <CIT>, which relates to an apparatus for treating a wall of a body cavity comprising an elongate probe member having a distal extremity with an outer surface and at least one recess opening onto the outer surface. When a suction source is coupled to the apparatus, a suction is created in the recess to draw a portion of the wall into the recess. A needle is slidably disposed in the elongate probe member and actuatable from outside the body for movement from a retracted position to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess.

There is consequently a need for an improved device for treatment of hemorrhoids that reduces the surgery time, treatment cost and improves the outcome of the surgery without the need of ligating the artery supply to the rectum.

The present invention relates to a device for use in the treatment of hemorrhoids that to at least some extent reduces the problems defined above, i.e. with improved handling, faster surgical intervention and a lower treatment cost.

The device for use in the treatment of hemorrhoids comprises:.

The device according to the invention is introduced in the rectum of the patient in order to make it possible for a surgeon to treat the hemorrhoids by surgery. Once the device is in the intended position, the prolapsed anal mocusa is arranged in the a least two cavities in the anal mucosa support device to ensure that the anal mocusa is arranged in the correct starting position relative the device.

The needle guide structure, formed in the elongated tube-shaped element and the anal mucosa support device, provides a reliable and efficient guide for a needle during movement within the tube shaped element from the extracted starting position across the at least two cavities in the hemorrhoid support device, i.e. through the anal mocusa arranged within the at least two cavities, to the position where the needle extend across the entire opening in the tube-shaped element.

The needle is used to introduce a suture thread, a staple or securing means through the anal mocusa. Different alternatives to enter the suture thread, the staple or securing means are described in the detailed description but generally this is achieved by introducing the suture thread, a staple or securing means together with the needle when the needle is moved from the retracted position to the extracted position, and then remove the needle such that the suture thread, a staple or securing means is remaining in the intended position through the anal mocusa. Alternatively the needle is first moved from the retracted position to the extracted position where the needle tip is secured in a coupling element of the suture thread, the staple or securing means such that the suture thread, the staple or securing means are introduced in the anal mocusa when the needle is retracted from the folds formed in the anal mocusa. As soon as the suture thread, staple or securing means is correctly positioned extending through the anal mocusa, the anal mocusa support device is removed from the opening and the device to free the anal mocusa and the suture thread, staple or securing means from the device which is essential to make it possible to tighten the suture thread, staple or securing means and permanently secure the suture thread, staple or securing means in the intended lifted position and, after the surgery is completed, remove the device from the rectum of the patient.

The device according to the invention facilitates the surgical treatment considerably since the needle guide structure and the anal mocusa support device ensures that the needle, and in the end the suture thread, staple or securing means, is extending along the intended path through the intended area of the anal mocusa arranged in each of the cavities which ensures that the desired result is achieved. The guided needle path ensurs that all surgical treatments will be conducted in inteded correct way since the manual sewing is eliminated.

In the case of severe hemorrhoid problems, the rectum mucosa needs to be lifted more. The device may be improved further by increasing the number of cavities in the anal mucosa support device. For example, the anal mocusa could comprise five cavities arranged along the longitudinal axis L such that futher folds on the anal mocusa are created and the lifting effect increased considerably.

Furthermore, several studies have shown that equally good results as by conventional methods can be achieved by only lifting the rectum mucosa without ligating the artery supply to the rectum.

Different types of suture wires, stamps or securing arrangement could be used in combination with the device according to the invention and when the needle and suture thread, staple or securing means is arranged extending through the anal mocusa the needle is removed and the suture thread, staple or securing means tightened and permanently secured such that the desired lift of the prolapsed anal mocusa is achieved.

The disclosed device facilitates for the surgeon to perform treatment of hemorrhoids by mucopexy with less variations in the operation procedure, suture depth and distance, since the needle is guided along the intended path through the anal mucosa. The device also ensures faster surgical intervention and the possibility to conduct the surgical treatment without the need of general anesthesia, which is feasible by the smaller diameter of the device for treatment of hemorrhoids, and results in considerably lower treatment cost.

The claimed device for use in the treatment of hemorrhoids could comprises more than one opening in the tube shaped element and corresponding anal mucosa support devices and needle guide structures arranged around the periphery of the elongated tube shaped element to make it possible to performe surgical treatment in two or more regions within the rectum of the patient without changing the positionon of the device. The fact that treatment could be made in further areas reduces the overal time for the surgical treatment.

In one embodiment of the device, the at least one needle is moved from the extracted position to the position where the at least one needle extend across the opening in the tube-shaped element substantially parallel to the longitudinal axis L. This embodiment is favourable since it is easy for the surgeon to controll and move the at least one needle via the open end of the elongated tube shaped element when the needle is guided substantially parallell to axis L.

According to the invention, the at least one needle guide structure comprises at least one needle passage arranged in the opening in the elongated tube-shaped element to guide the at least one needle during movement from the extracted position to the position where the needle extend across the opening in the tube-shaped element. This ensures that the needle is extending in the intended direction across the opening. Further needle passages along the intended direcion of the needle provide further guidance during insertion of the needle.

In one embodiment of the device, the at least one needle guide structure comprises needle guide elements arranged in the elongated tube-shaped element on each side of the opening in the tube shaped element to guide the needle. This embodiment is favourable since the needle is guided on both sides of the opening.

In one embodiment of the device, the at least one needle passage is formed in the contact surface between the elongated tube-shaped element and the anal mucosa support device such that the at least one needle passage is opened when the anal mucosa support device is removed from the elongated tube-shaped element. This embodiment is favourable since the needle and / or the suture wire, stamp or securing arrangement is easily released from the device which is necessary to extrac the device from the rectum of the patient.

According to the invention, the anal mucosa support device comprises a first and a second elongated part extending substantially parallel to axis L, said first and second part are arranged adjacent to each other and the at least one needle passage formed in the contact surface between the first and second part such that the at least one needle passage is opened when the first and second part are separated from each other. With this configuration the needle and I or the suture wire, stamp or securing arrangement is released in an effective way from the device.

One embodiment of the device, comprises two needle guide structures formed in the elongated tube-shaped element and the anal mucosa support device such that two needles are guided during movement within the tube shaped element from an extracted position in which the needles are arranged outside the opening in the elongated tube-shaped element across the at least two cavities in the anal mocusa support device to a position where the needles extend across the opening in the tube-shaped element. This embodiment is favourable since this embodiment provides for two suture wires, stamps or securing arrangements side by side which reduces the risk for failure, tearing of the tissue/mocusa or reduced effect of the intended lift of the anal mocusa and provides a stronger more resistant liftin effect.

In one embodiment of the device, the anal mucosa support device comprises a first, a second and an intermediate elongated part extending substantially parallel to axis L, said first and second part are arranged arranged on opposite sides of the intermediate part adjacent to the intermediate part such that one needle passage is formed in the contact surface between the first part and the intermediate part, and second needle passage is formed in the contact surface between the intermediate part and the second elongated part such that the two needle passages are opened when the first, second and intermediate elongated part are separated from each other. This embodiment of the anal mocusa support device provides an efficient guiding for both needles during movement from the retracted position across the opening in the tube shaped element.

In one embodiment of the device, the two needle guide structures are arranged to guide the two needles substantially parallell from the extracted position in which the needles are arranged outside the opening in the elongated tube-shaped element across the at least two cavities in the anal mocusa support device to the position where the needles extend across the opening in the tube-shaped element. The two needles are furthermore guided in a direction substantially parallell to the longitudinal axis which is favourable since it facilitates for the surgeon to insert and move the needles via the open end of the tube shaped element.

In one embodiment of the device, the tube shaped element is divided into at least a forward and a rear part and said forward part is removably attached to the rear part in order to facilitate the manufacturing of the tube shaped element and the assembly of the different components arranged within the tube shaped element.

One embodiment of the device comprises a sealing plug arranged to close and seal the open aft end of the device and a connection with access to the interior of the tube shaped element, said connection is intended to be connected to pumping means such that the pressure within the tube shaped element could be reduced and the anal mocusa sucked into the at least two cavities to facilitate the treatment of the patient. The pumpint means is for example a manuall or electrically powered pump or an externally arranged source of sucking action, such that the anal mocusa could be sucked into the at least two cavities of the device.

In one embodiment of the device, the sealing plug comprises the connection intended to be connected to pumping means.

In one embodiment of the device, the device comprises a handle extending in substantially radial direction from the longitudinal axis L from the aft end of the tube shaped element and the connection with access to the interior of the tube shaped element is arranged in the handle.

In one embodiment of the device, the at least two cavities in the anal mucosa support device comprises a bottom structure and the distance in radial direction from axis L between the centre of the needle passage and the bottom structure is between <NUM> and <NUM>. This embodiment provides a reliable securing once the suture thread, staples or securing means is tensioned and permanently secured since the fold of the anal mocusa will have sufficient strength and not break.

In one embodiment of the device, the bottom structure comprises at least one opening in each cavity such that the anal mucosa is sucked into the at least two cavities. This embodiment is favourable since the anal mocusa will be sucked towards the bottom structure ensuring the same suture depth in the anal mocusa at every procedure.

In one embodiment of the device, the at least two cavities in the anal mocusa support device comprises a bottom structure, and the cavitiy arranged in the forward end of the anal mucosa support device along axis L have a larger distance in radial direction from axis L between the centre of the needle passage and the bottom structure than the at least one other cavity. This embodiment provides a reliable securing once the suture thread, staple or securing means is tensioned and permanently secured since the fold in the inner end of the treated area will be larger than the other fold, or folds, and thereby provide a reliable securing of the anal mocusa folds and ensure the desired inward lift of the anal mocusa.

In one embodiment of the device, the anal mucosa support device is maintained in the intended position within the tube-shaped element by a locking element removably arranged within the tube shaped element to force the anal mucosa support device into the intended position with the at least two cavities exposed in the opening of the tube-shaped element. This embodiment is favourable since the the anal mocusa support device, when the locking element is removed, could be moved radially inwards and easily removed from the opening in the tube shape element. In one embodiment of the device, the locking element is forming a bottom surface in the cavities in the anal mucosa support device. This embodiment provides a device with less complicated structure and ensures that the device will work as intended.

One embodiment of the device comprising at least one closing element removably arranged in the tube-shaped element to close the at least one opening in the tube-shaped element and facilitate insertion of the device.

In one embodiment of the device, the closing element has a shape corresponding to the shape of the tube-shaped element to provide a smooth outer surface of the device and facilitate insertion of the device.

The above as well as further objectives, features and advantages with the present invention will become apparent when studying the following illustrative and non-limiting detailed disclosure of preferred embodiments of the present invention, with reference to the appended drawings:.

All figures are schematic, not necessarily to scale, and generally only illustrating selected parts which are necessary in order to elucidate the invention, wherein other parts may be omitted or merely suggested.

The present invention, as previously stated, relates to a device <NUM> for use in treatment of hemorrhoids. The device comprises an elongated tube-shaped element <NUM> that constitues the outer casing of the device. The tube-shaped element <NUM> comprising a rounded forward end <NUM> that is intended to be arranged in the rectum of the patient. The tube-shaped element further comprises an open aft <NUM> end intended to be arranged outside the rectum of the patient during use of the device. The aft end <NUM> is slightly curved outwards. Within the tube-shaped element an interior cavity accessible via the open aft end <NUM> is formed. The tube-shaped element is substantially straight and extending along a longitudinal axis L. The tube shaped element could be made in different lengths and the cross sectional shape of the tube-shaped element transverse to axis L is substantially circular in order to facilitate the insertion of the device when the treatment is initiated. Alternative cross sectional shapes could also be oval, triangular, rectangular, pentagonal or hexagonal etc with rounded corners. The tube shaped element is preferably made of a plastic material.

The tube-shaped element furthermore comprises at least one opening <NUM>, illustrated in <FIG>, formed in the tube shaped element wall and arranged between the forward <NUM> and aft end <NUM>. The opening <NUM> has substantially the same width transverse to the axis L and extend between the forward and aft end. Furthermore a handle <NUM> is extending in substantially radial direction from axis L from the aft end of the tube shaped element to facilitate movement of the device during use. Further handles could be provided and the design of the handle modified in different ways within the scope of the invention.

The device <NUM> furthermore comprises an anal mucosa support device <NUM>, illustrated for example in <FIG>. The illustrated embodiment of the anal mocusa support device comprises a first <NUM> and a second <NUM> elongated part arranged to extend substantially parallel to axis L. The first and second elongated part are arranged adjacent to each other and intended to be removably arranged within the tube shape element such that the anal mocusa support device <NUM>, when arranged in the intended position within the tube-shaped element, is exposed in the opening <NUM> in the tube-shaped element <NUM>. The anal mocusa support device comprises a least two cavities <NUM> for the anal mucosa but the illustrated embodiment comprises four cavities <NUM> with substantially equal size and a larger fifth cavity <NUM> formed by the forward end of the anal mocusa support device when arranged in the intended position in the tube shaped element <NUM>. The cavities <NUM>, <NUM> are arranged along the longitudinal axis L substantially in the centre of the opening in the tube shaped element. Each cavity have an open side facing the opening <NUM> in the tube shaped element <NUM> such that the anal mocusa can enter each of the cavities.

The first <NUM> and a second <NUM> elongated part are designed to be arranged adjacent to each other substantially in the centre of the opening and each of the cavities <NUM>, <NUM> are arranged along the contact surface between the first <NUM> and a second <NUM> elongated part such that the cavities are formed by substantially identical half cavities in the first and the adjacent second elongated part, i.e. half of the cavity is formed by one of the elongated parts and the other half of the cavity by the other elongated part. Furthermore, needle passages <NUM> are formed along the contact surface between the first and second part. The illustrated embodiment of the device comprises four needle passages <NUM>, i.e. one needle passage between each of the cavities in the anal mocusa support device. The needle passages <NUM> are opened when the first and second part are separated from each other to release a needle, or a suture thread, a staple or securing means extending through the needle passage <NUM>.

The needle passages <NUM> constitues the needle guide structure formed in the elongated tube-shaped element <NUM> and the anal mucosa support device <NUM> such that a needle <NUM> is guided during movement within the tube shaped element from an extracted position in which the needle is arranged outside the opening <NUM> in the elongated tube-shaped element <NUM> through the cavities in the anal mocusa support device to a position where the needle extend across the opening in the tube-shaped element. Each needle passage <NUM> has a size and shape corresponding to the cross sectional dimension and shape of the needle such that the needle is able to easily pass through each needle passage when the needle is moved from the retracted to the extracted position. Preferably the side of the needel passage that is facing the aft end of the device is slightly widened to guide the needle into the centre of the needle passage <NUM>.

Each cavity <NUM>, <NUM> in the anal mucosa support device <NUM> comprises a bottom structure <NUM> and the distance in radial direction from axis L between the centre of the needle passage and the bottom structure is between <NUM> and <NUM>. In order to ensure that the anal mocusa is correctly arranged in the cavities <NUM>, <NUM> in the anal mocusa support device <NUM>, the bottom structure of each cavity comprises at least one opening <NUM> in each cavity, said openings <NUM> are connected to some sort of means that is able to provide a pressure below the surrounding pressure, such as for example a manuall or electrically powered pump or an externally arranged source of sucking action, such that the anal mucosa is sucked into the cavities.

The anal mucosa support device <NUM> is removably arranged within the tube shaped element <NUM> and maintained in the intended position within the tube-shaped element by a removable locking element <NUM>. The locking element is shaped like an elongated plate <NUM> with a length, along axis L, and width corresponding to the interior dimensions of the elongated tube element. The positioning and securing of the locking element within the tube shaped element is provided by guiding rails <NUM> arranged along the inner peripheral wall of the tube shaped element on each side of the opening in the tube shaped element such that the locking element could slide paralell to the longitudinal axis L. The first and second element of the anal mocusa support is fitted within a recess <NUM> on the side of the locking element that is facing the opening <NUM> in the tube shaped element such that the first and second element <NUM>, <NUM> are maintained in the intended position. The locking element <NUM> is arranged within the tube shaped element to force the anal mucosa support device <NUM> into the intended position and maintain the anal mocusa support device in the intended position with the cavities exposed in the opening of the tube-shaped element. In the illustrated embodiment of the anal mocusa support device and the locking element the cavities have an open bottom structure that is closed by the locking element <NUM>.

In the above description of the device <NUM> only one arrangement comprising one opening <NUM> in the tube shaped element <NUM>, one anal mucosa support device <NUM> and one locking element <NUM> has been described but preferably the device <NUM> is designed to comprise two, alternatively three or up to six similar, corresponding substantially identical arrangements each comprising one opening in the tube shaped element, one anal mucosa support device and one locking element. If the device comprises two arrangements which are illustrated in <FIG>, the openings are arranged opposite to each other in the tube shaped element and if the device comprises three or more arrangements, these are arranged at substantially equal distance from each other around the tube shaped element.

The device <NUM> is introduced in the rectum of the patient in order to make it possible for a surgeon to treat the hemorrhoids by surgery. Once the device is in the intended position, the prolapsed anal mocusa is arranged in the cavities <NUM>, <NUM> in the anal mucosa support device <NUM>. The needle guide structure, formed in the elongated tube-shaped element and the anal mucosa support device, provides guidance for the needle, or needles, <NUM> during movement within the tube shaped element from the extracted starting position, through the cavities <NUM>, <NUM>, i.e. through the anal mocusa arranged within the cavities, to the position where the needle <NUM> extend across the entire opening <NUM> in the tube-shaped element <NUM> and through the anal mocusa arranged in the different cavities such that folds are generated in the anal mocusa.

The needle <NUM> is used to introduce a suture thread, a staple or securing means through the different folds of the anal mocusa. Different alternatives to enter the suture thread, the staple or securing means could be used. Either the suture thread, staple or securing means is introduced together with the needle, or the needle is first moved from the retracted position to the extracted position where the needle tip is secured in a corresponding docking element <NUM> in the end of a suture thread, a staple or securing means arranged within the forward end of the device, illustrated in <FIG> and described in detail later in this description. The suture thread, the staple or securing means is introduced in the anal mocusa when the needle is retracted from the extracted position and the suture thread, the staple or securing means are drawn through the anal mocusa. As soon as the suture thread, staple or securing means is correctly positioned, the anal mocusa support device <NUM> removed from the opening and the device <NUM> via the open aft end <NUM> to free the anal mocusa and the suture thread, staple or securing means from the device which is essential to make it possible to remove the device form the rectum after the the suture thread, staple or securing means are tightened and permanently secured.

The device <NUM> according to the invention facilitates the surgical treatment since the needle guide structure and the anal mocusa support device <NUM> ensures that the needle <NUM>, and in the end the suture thread, staple or securing means, is extending through the intended area of the anal mocusa arranged in each of the cavities <NUM>, <NUM> which ensures that the desired result is achieved.

In the case of severe hemorrhoid problems, the rectum mucosa needs to be lifted more. The device may be improved further by increasing the number of cavities in the anal mucosa support device such that futher folds on the anal mocusa are created, which results in that the lifting effect is increased considerably.

The device <NUM> furthermore comprises one closing element <NUM> for each opening <NUM> in the tube shaped element <NUM>. The closing element <NUM> has a shape corresponding to the cross sectional shape of the tube-shaped element <NUM> to provide a smooth outside shape of the device <NUM> and a length corresponding to the length of the opening <NUM> to completely close the opening when arranged in the device. The closing element is removably arranged in the tube-shaped element and intended to close the opening in the tube shaped element to facilitate insertion of the device in the rectum of the patient. When the device is in the desired position in the rectum, the closing element that is extending all the way to the aft end of the device is removed via the aft end <NUM> of the tube shaped element <NUM> to expose the opening in the tube shaped element and make it possible for the anal mocusa to acess the cavities. The closing element <NUM> is arranged to slide in substantially straight recesses <NUM>, illustrated in <FIG>, formed along the elongated sides of the opening <NUM> in the tube shaped element substantially parallel to the longitudinal axis L. In the illustrated embodiment of the tube shaped element and closing element, the closing element exits the tube shaped element via a slot <NUM> in the curved section in the aft end <NUM> of the tube shaped element <NUM>. The slot has a shape corresponding to the shape of the closing element.

When the device is fitted in the intended position in the rectum of the patient and the closing element are removed, the open aft end <NUM> of the tube shaped element <NUM> is closed by a sealing plug <NUM>. The locking element <NUM> and the anal mocusa support <NUM> ends in the open aft end <NUM> of the tube shaped element <NUM> and the sealing plug <NUM> is designed to fit in the open aft end <NUM> and close and seal the open aft end <NUM> of the device <NUM> such that pumping or suction means could be connected to the interior of the tube shaped element <NUM> via a connection <NUM> in said sealing plug <NUM>. The sealing plug could also be provided with an elastic tube extending from the plug to facilitate the connection to the pumping or suction means. Alternative embodients to provide the desired connection of pumping or suction means to the interior of the tube shaped elements are also possible. For example, the pumping or suction means could be connected to the interior of the device via a connection, not illustrated, arranged on the aft end of the device or the handle and a channel integrated in the device and connected to the interior of the tube-shaped elements <NUM>. When the pumping or suction means, not illustrated, are activated the pressure within the tube shaped element <NUM> is reduced and the anal mocusa is sucked into the cavities.

Once the anal mocusa is in the desired position within the cavities <NUM>, <NUM>, the needle <NUM> is pushed from the retracted postion through the needle passages <NUM>, across the cavities <NUM>, <NUM> and the anal mocusa arranged in the cavities all the way to the opposite side of the opening <NUM> in the tube shaped element <NUM>.

The needle <NUM> is extending substantially parallel to the longitudinal axis L through a needle sleeve <NUM>, illustrated in <FIG>. The needle sleeve <NUM> is intended to be arranged within a space formed by a first sleeve support <NUM> in one of the elongated parts <NUM> and a corresponding adjacent second sleeve support <NUM> in the other elongated part <NUM> aft of the opening <NUM> in the the tube shaped element <NUM>. The sleeve <NUM> is intended to maintain and support the needle <NUM> in the intended position within the tube shaped element of the device <NUM> and guide the needle <NUM> during movement from the retracted position across the opening <NUM>. The sleeve <NUM> is designed to provide a thight fitting to the exterior of the needle, and the first and second sleeve supports <NUM>, <NUM> are designed to provide a thight fitting to the needle sleeve to prevent that air is leaking through the gaps between the needle and the needle sleeve as weel between the needle sleeve and the first and second sleeve support <NUM>, <NUM> from the surrounding space into the closed space within the tube shaped element.

The needle is allowed to move forward and backwards in the sleeve <NUM>. When the locking element <NUM> and the anal mocusa support device <NUM> is removed from the tube shaped element, the needle sleeve <NUM> is released and either removed or used to facilitate the tensioning of the sutur thread, staple or fastening means to secure the anal mocusa in the lifted position.

In <FIG> a prespective view of the device <NUM>, the opening <NUM> in the tube shaped element and the anal mocusa support device prior to the movement of the needle is illustrated. The device comprises four equally sized cavities <NUM> and one larger cavity <NUM> arranged in the forward end of the anal mocusa support device and the opening in the tube shaped element. Each of the cavities comprises a bottom structure <NUM>, and the cavity arranged in the forward end of the anal mucosa support device along axis L have a larger distance in radial direction from axis L between the centre of the needle passage and the bottom structure than other cavities to generate a stronger and more resistant securing in the larger inner fold of the anal mocusa.

In <FIG>, <FIG> and <FIG> perspective views of the the anal mocusa support device and a needle moved to the position where it is extending through the cavities are illustrated. In order to more clearly illustrate the anal mocusa support device and needle, the anal mocusa is not illustrated. In <FIG> one of the elongated parts <NUM> of the anal mocusa support has been removed to more clearly illustrate the needle and the needle passages <NUM> formed between the first and second elongated part. In <FIG>, both the first <NUM> and second <NUM> elongated part of the anal mocusa support and the locking element <NUM> are removed.

The claimed device for use in the treatment of hemorrhoids could comprises more than one opening in the tube shaped element and corresponding anal mucosa support devices and needle guide structures to make it possible to performe surgical treatment in two or more regions within the rectum of the patient without changing the positionon of the device. The fact that treatment could be made in further areas reduces the overal time for the surgical treatment.

An alternative embodiment of the device according to the invention is illustrated in <FIG>, <FIG>, <FIG> and <FIG>. This embodiment comprises two needle guide structures formed in the elongated tube-shaped element and the anal mucosa support device such that two needles could be guided during movement within the tube shaped element from an extracted position in which the needles are arranged outside the opening in the elongated tube-shaped element across the at least two cavities in the anal mocusa support device to a position where the needles extend across the opening in the tube-shaped element. This embodiment is favourable since this embodiment provides for two suture wires, stamps or securing arrangements side by side which provides an improved lifting effect when the suture thread, staple or securing means are tightened, and provides a stronger more resistant lifting effect.

This embodiment of the device <NUM>" comprises the same type of elongated tube-shaped element <NUM>" with a rounded forward end <NUM>", preferably removably connected to the body of the tube shaped element to facilitate assembly of the different components of the device, and the slightly curved open aft <NUM>". The length, cross sectional shape and diameter could be adapted to suit different patients.

In the tube-shaped element, the same type of opening <NUM>" is formed between the forward <NUM>" and aft end <NUM>". The opening <NUM> has a substantially constant width along the direction parallel to axis L.

The anal mocusa support device <NUM>" comprises a first <NUM>", a second <NUM>" and an intermediate <NUM> " elongated part arranged to extend substantially parallel to axis L.

The first and second part are arranged arranged on opposite sides of the intermediate part adjacent to the intermediate part such that one needle passage <NUM>" is formed in the contact surface between the first part and the intermediate part, and the second needle passage <NUM>" is formed in the contact surface between the intermediate part and the second elongated part.

The anal mocusa support device <NUM>" is removably arranged within the tube shape element such that the anal mocusa support device <NUM>" is exposed in the opening <NUM>". The anal mocusa support device comprises four cavities <NUM>" with substantially equal size and a larger fifth cavity <NUM>" formed in the forward end.

The first, second and intermediate part are designed to be arranged adjacent to each other and the first and second needle passages <NUM>" and <NUM>" are formed along the contact surface between the first and intermediate part, and the intermediate and second part. The illustrated embodiment of the device comprises five needle passages. The needle passages constitues the needle guide structure that provides the desired guide for the respective needle <NUM> ", <NUM>" during movement within the tube shaped element from the extracted position through the cavities.

The anal mucosa support device is removably arranged within the tube shaped element and maintained in the intended position within the tube-shaped element by a removable locking element <NUM>" as described above in relation to the first embodiment of the device. In the same way as above, a device according to the invention comprising an anal mocusa support device and one locking element has been described but the device could comprise two, alternatively three or more, corresponding substantially identical arrangements. If the device comprises two arrangements which are illustrated in <FIG>, the openings are arranged opposite to each other in the tube shaped element and if the device comprises three, or more, arrangements these are arranged at substantially equal distance from each other around the tube shaped element.

In the appended drawings different embodiments of the device according to the invention are illustrated. A plurality of the components of the device may however be modified in a plurality of ways without departing from the scope of the invention as defined by the appended claims.

The device according to the invention could be used in combination with different alternatives to secure the anal mucosa in the lifted position and three possible options will now be described with reference to the corresponding figures.

The first alternative is schematically illustrated in <FIG>. In the forward end of the device <NUM>, a forward stop element <NUM> is removably arranged forward of the opening <NUM> in the tube shaped element <NUM> before the treatment is initiated. The needle comprises a needle tip <NUM> and a needle body <NUM> shaped like a tube. The needle tip is releasable from the needle body and a suture thread <NUM> with a length exceeding the needle body length is extending from the aft end of the needle body through the needle body to the needle tip <NUM> where it is permanently secured in the needle tip <NUM>. The stop element <NUM> is positioned in the intended forward position of the needle tip <NUM>. When the device <NUM> is in the desired position within the rectum of the patient, the needle is moved from the retracted position through the cavities to the forward stop element <NUM> where the needle tip <NUM> penetrates the forward stop element <NUM> and permanently secures to the forward stop element <NUM>. The permanently securing between the forward stop element and the needle tip could be achieved in different ways like for example a male / female fitting. The needle body <NUM> is then retracted to free the suture thread <NUM> that is extending through the anal mucosa. Once the needle body is removed, also the sealing plug <NUM>, the locking element <NUM> and the anal mucosa support device <NUM> are removed to free the tread and the anal mucosa from the anal mucosa support device. In order to achieve the desired lift of the anal mucosa an aft stop element <NUM> is pushed forwards along the tread to force the anal mucosa folds towards the forward stop element <NUM>. The aft stop element <NUM> and the suture tread <NUM> are either provided with a corresponding securing structure that prevents the rear stop element <NUM> from moving backwards along the thread or permanently secured in the desired position by for example a knot. The aft stop element <NUM> is either arranged on the thread and positioned forward of the needle sleeve <NUM> before the treatment is initiated or arranged on the tread once the needle body and needle sleeve are removed from the tread.

A second alternative is illustrated in <FIG>. Within the forward end of the device <NUM>, a suture tread <NUM> is arranged inside the device before the treatment is initiated. In one end of the suture tread a forward stop element <NUM> is permanently secured and in the opposite end of the suture thread docking means <NUM>, for example a loop or male/female fitting, are arranged. The docking means <NUM> are positioned in the intended forward position of the needle tip <NUM>. When the device <NUM> is in the desired position within the rectum of the patient, the needle <NUM> is moved from the retracted position through the cavities to the docking means <NUM> where the needle tip <NUM> connects to the docking means <NUM> such that the needle is connected to the docking means <NUM>. The needle is then retracted together with the suture tread to a position where the forward stop element <NUM> rest against the forward fold of the anal mucosa. Once the needle is removed, also the sealing plug <NUM>, the locking element <NUM> and the anal mucosa support device <NUM> are removed to free the tread <NUM> and the anal mucosa from the anal mucosa support device. In order to achieve the desired lift of the anal mucosa an aft stop element <NUM> is pushed forwards along the tread to force the anal mucosa folds towards the forward stop element <NUM>. The aft stop element <NUM> and the suture tread <NUM> are either provided with a corresponding securing structure that prevents the rear stop element <NUM> from moving backwards along the thread or permanently secured in the desired position by for example a knot. The aft stop element <NUM> is arranged on the thread once the needle and needle sleeve are removed from the tread.

A very simple and reliable embodiment based on this general idea involves an elongated suture thread arranged loaded within the device before the surgery is initiated. On end of the suture thread comprises a docking element <NUM>. Once the needle is introduced the needle tip is connected to the docking element <NUM> and the thread introduced through the anal mocusa when the needle is retracted. The length of the suture thread is at least long enough to ensure that the both ends of the suture thread extend all the way out through the open end of the device such that the surgeon can secure the ends of the thread by one or more knots and lift the anal mocusa.

This embodiment is also very favorable in combination with the embodiment of the device comprising two parallel needles since one single suture tread could be arranged in the forward end of the device with one end provided with docking means <NUM> positioned in the forward end of one needle, and the second end of the suture tread provided with similar docking means <NUM> positioned in the forward end of the other needle. Once the two needles have docked to the corresponding docking mean <NUM> both ends of the suture tread are retracted through the folds of the anal mocusa such that both ends are extending out of the aft end of the device. After the desired lift of the anal mocusa is achieved the two ends could be secured by one, or more, reliable knots.

A third alternative is illustrated in <FIG>. In the forward end of the device <NUM>, a forward stop element <NUM> is removably arranged forward of the opening <NUM> in the tube shaped element <NUM> before the treatment is initiated. From the forward stop element <NUM> a suture thread <NUM> is extending to the aft end of the tube shaped element <NUM>. The needle comprises a needle tip <NUM> and a needle body <NUM> shaped like a pipe. The needle tip is releasable from the needle body and a suture thread <NUM> with a length exceeding the needle body length is extending from the aft end of the needle body through the needle body to the needle tip <NUM> where it is permanently secured in the needle tip <NUM>. The stop element <NUM> is positioned in the intended forward position of the needle tip <NUM>. When the device <NUM> is in the desired position within the rectum of the patient, the needle is moved from the retracted position through the cavities to the forward stop element <NUM> where the needle tip <NUM> penetrates the forward stop element <NUM> and permanently secures to the forward stop element <NUM>. The permanently securing between the forward stop element and the needle tip could be achieved in different ways like for example a male / female fitting. The needle body <NUM> is then retracted to free the suture thread <NUM> that is extending through the anal mucosa. Once the needle body is removed, also the sealing plug <NUM>, the locking element <NUM> and the anal mucosa support device <NUM> are removed to free the thread <NUM> and the anal mucosa from the anal mucosa support device. The anal mucosa arranged along the suture thread <NUM> is pushed forwards along the tread to force the anal mucosa folds towards the forward stop element <NUM>. The suture thread <NUM> extending from the needle tip <NUM> and the suture thread <NUM> extending from the forward stop element <NUM> are then secured together by one or more knots to secure the anal mucosa in the lifted position.

A fourth possible alternative is a combination of the previously described alternatives. This alternative is not illustrated in any figure. Within the forward end of the device <NUM>, a suture tread is arranged before the treatment is initiated. Close to the center of the suture thread a forward stop element is permanently secured on the suture thread. One of the ends of the suture thread is lead to a position outside the aft end of the device. The other end of the suture thread is ended by docking mean, for example a loop or male/female fitting, arranged in the position of the needle tip in the forward position. When the device is in the desired position within the rectum of the patient, the needle is moved from the retracted position through the cavities to the docking means where the needle tip connects to the docking means. The needle is then retracted together with the suture tread to a position where the forward stop element rest against the forward fold of the anal mucosa. Once the needle is removed, also the sealing plug, the locking element and the anal mucosa support device are removed to free the tread and the anal mucosa from the anal mucosa support device. The anal mucosa arranged along the suture thread is pushed forwards along the tread to force the anal mucosa folds towards the forward stop element. The two parts of the suture thread extending from the forward stop element then secured together by one or more knots to secure the anal mucosa in the lifted position.

Claim 1:
A device (<NUM>; <NUM>") for use in the treatment of hemorrhoids, said device comprising:
an elongated tube-shaped element (<NUM>; <NUM>") comprising a forward end (<NUM>; <NUM>") and an aft end (<NUM>; <NUM>"), said aft end is open such that the interior of the tube-shaped element is accessible via the aft end, said tube-shaped element is extending along a longitudinal axis L and comprises at least one opening (<NUM>; <NUM>") formed between the forward and aft end; and
an anal mucosa support device (<NUM>; <NUM>") removably arranged within the tube-shape element, said support device comprises:
a first (<NUM>) and a second (<NUM>) elongated part adjacently arranged to each other and extending substantially parallel to axis L, and
at least two cavities (<NUM>, <NUM>) for the anal mucosa arranged along a contact surface between the at least one first and second elongated part such that the cavities are formed by substantially identical half cavities in the first and adjacent second elongated part,
said support device is, when arranged in the tube-shaped element, exposed in the opening,
wherein at least one needle guide structure is formed in the elongated tube-shaped element and the anal mucosa support device, said at least one needle guide structure is configured to guide at least one needle (<NUM>; <NUM>"; <NUM>") during movement within the tube-shaped element from an extracted position in which the needle is arranged outside the opening in the elongated tube-shaped element across the at least two cavities in the anal mocusa support device to a position where the needle extends across the opening in the tube-shaped element, parallel to the longitudinal axis L,
wherein
the at least one needle guide structure comprises at least one needle passage (<NUM>; <NUM>"; <NUM>") arranged in the opening in the elongated tube-shaped element to guide the at least one needle during movement from the extracted position to the position where the needle extends across the opening in the tube-shaped element, and
in that the at least one needle passage (<NUM>) is formed in the contact surface between the first and second elongated part such that the at least one needle passage is opened when the first and second elongated part are separated from each other.