阅读说明：本技术 用于在治疗痔疮时使用的设备 (Device for use in the treatment of hemorrhoids ) 是由 约翰·翁格斯泰特 于 2018-10-12 设计创作，主要内容包括：本发明涉及一种用于在治疗痔疮时使用的设备(10)。该设备包括：细长管状元件(12),该细长管状元件包括前端(13)和后端(14),所述后端(14)是开放的,使得可经由该后端触及该管状元件的内部,所述管状元件沿着纵向轴线L延伸,并包括形成在该前端与该后端之间的至少一个开口(15)；以及肛门粘膜支撑设备(20),该肛门粘膜支撑设备可移除地布置在该管状元件内,所述支撑设备在布置在该管状元件中时暴露在该开口中,并包括沿着该纵向轴线L布置的用于肛门粘膜的至少两个腔体(23,24),其中,针引导结构形成在该细长管状元件和该肛门粘膜支撑设备中,使得针(100)在该管状元件内从抽出位置穿过该肛门粘膜支撑设备中的至少两个腔体移动到该针延伸穿过该管状元件中的开口的位置期间被引导,在该抽出位置,该针布置在该细长管状元件中的开口外部。(The invention relates to a device (10) for use in the treatment of hemorrhoids. The apparatus comprises: an elongated tubular member (12) comprising a front end (13) and a rear end (14), said rear end (14) being open such that the interior of the tubular member is accessible via the rear end, said tubular member extending along a longitudinal axis L and comprising at least one opening (15) formed between the front end and the rear end; and an anal mucosa support device (20) removably arranged within the tubular element, said support device being exposed in the opening when arranged in the tubular element and comprising at least two cavities (23, 24) for anal mucosa arranged along the longitudinal axis L, wherein a needle guide structure is formed in the elongated tubular element and the anal mucosa support device such that a needle (100) is guided during movement of the needle within the tubular element from a withdrawn position, in which the needle is arranged outside the opening in the elongated tubular element, through the at least two cavities in the anal mucosa support device to a position in which the needle extends through the opening in the tubular element.)

1. A device (10; 10 ") for use in treating hemorrhoids, the device comprising:

an elongated tubular member (12; 12 ') comprising a front end (13; 13') and a rear end (14; 14 ') open so that the interior of the tubular member is accessible via the rear end, said tubular member extending along a longitudinal axis L and comprising at least one opening (15; 15') formed between the front end and the rear end; and

an anal mucosa support device (20; 20') removably arranged inside the tubular element, said support device being exposed in the opening when arranged in the tubular element and comprising at least two cavities (23, 24) for anal mucosa arranged along the longitudinal axis L,

wherein at least one needle guiding structure is formed in the elongated tubular member and the anal mucosa support device such that at least one needle (100; 1001 "; 1002") is guided during movement within the tubular member through at least two cavities in the anal mucosa support device from an extracted position, in which the needle is arranged outside the opening in the elongated tubular member, to a position in which the needle extends through the opening in the tubular member.

2. The apparatus according to claim 1, wherein the at least one needle is moved from the extracted position parallel to the longitudinal axis L to a position where the needle extends through the opening in the tubular element.

3. Device according to claim 1 or 2, wherein the at least one needle guiding structure comprises at least one needle channel (25; 251 "; 252") arranged in an opening in the elongate tubular member for guiding the at least one needle during movement from the withdrawn position to a position in which the needle extends through the opening in the tubular member.

4. Device according to any of the preceding claims, wherein the at least one needle guiding structure comprises at least one needle guiding element (101) arranged in the elongate tubular element on both sides of an opening in the tubular element for guiding the needle.

5. A device according to claim 3 or 4, wherein the at least one needle channel is formed in a contact surface between the elongated tubular member and the anal mucosa support device such that the at least one needle channel is opened when the anal mucosa support device is removed from the elongated tubular member.

6. Device according to claim 3 or 4, characterized in that the anal mucosa support device comprises a first elongated portion (21) and a second elongated portion (22) extending substantially parallel to the axis L, said first portion and said second portion being arranged adjacent to each other, and the at least one needle passage (25) is formed in the contact surface between the first elongated portion and the second elongated portion such that the at least one needle passage is opened when the first elongated portion and the second elongated portion are separated from each other.

7. Device according to claim 3 or 4, comprising two needle guiding structures formed in the elongated tubular member and the anal mucosa support device such that two needles (1001 "; 1002") are guided during movement inside the tubular member through at least two cavities in the anal mucosa support device from a withdrawn position, in which the needles are arranged outside the opening in the elongated tubular member, to a position in which the needles extend through the opening in the tubular member.

8. The device according to claim 7, characterized in that the anal mucosa support device comprises a first elongated portion (21 "), a second elongated portion (22") and an intermediate elongated portion (215 ") extending substantially parallel to the axis L, said first portion and said second portion being arranged adjacent to the intermediate portion on opposite sides thereof such that a first needle channel (251") is formed in the contact surface between the first portion and the intermediate portion and a second needle channel (252 ") is formed in the contact surface between the intermediate portion and the second elongated portion such that the two needle channels are opened when the first elongated portion, the second elongated portion and the intermediate elongated portion are separated from each other.

9. The device according to claim 7 or 8, wherein the two needle guiding structures are arranged to guide the two needles substantially in parallel from the extracted position, in which the needles are arranged outside the opening in the elongated tubular member, through at least two cavities in the anorectal support device, to a position in which the needles extend through the opening in the tubular member.

10. Device as claimed in any of the foregoing claims, characterized in that the tubular element is divided into at least a front part and a rear part, and that the front part is removably attached to the rear part.

11. Device according to any one of the preceding claims, characterized in that it comprises: a sealing plug (50) arranged to close and seal the open rear end of the apparatus; and a connection having access to the interior of the tubular element, said connection being intended to be connected to a pumping device, such that the pressure inside the tubular element can be reduced and the anal mucosa is sucked into the at least two cavities.

12. Device according to claim 11, characterized in that the sealing plug (50) comprises a connection piece (51) intended to be connected to a pumping means.

13. Device according to claim 11, characterized in that the device comprises a handle (16) extending from the rear end of the tubular element in a substantially radial direction with respect to the longitudinal axis L, and in that a connection having access to the interior of the tubular element is arranged in the handle.

14. Device according to any one of claims 11 to 13, characterized in that at least two cavities in the anal mucosa support device comprise a bottom structure (26) and the distance from the axis L in radial direction between the centre of the needle passage (25) and the bottom structure (26) is between 2mm and 12 mm.

15. Device according to claim 14, characterized in that the bottom structure comprises at least one opening (27) in each cavity, so that the anal mucosa is sucked into the at least two cavities.

16. Device according to any one of claims 1 to 10, characterized in that at least two cavities in the anal mucosa support device comprise a bottom structure and that the cavity (24) arranged in the front end of the anal mucosa support device along axis L is at a greater distance from axis L in a radial direction between the centre of the needle passage and the bottom structure than at least one other cavity.

17. Device according to any one of the preceding claims, characterized in that the anal mucosa support device is held in the desired position within the tubular element by arranging a removable locking element (30) within the tubular element to push the anal mucosa support device into the desired position and the at least two cavities are exposed in the opening of the tubular element.

18. Device according to claim 17, characterized in that the locking element forms the bottom structure (26) of the cavities in the anal mucosa support device.

19. The device according to any one of the preceding claims, comprising at least one closing element (40) removably arranged in the tubular element to close at least one opening in the tubular element and facilitate insertion of the device.

20. An apparatus according to claim 17, wherein the closing element has a shape corresponding to the shape of the tubular element.

Technical Field

The present invention relates to a device for use in the treatment of hemorrhoids.

Background

Up to 25% of people over the age of 50 suffer from hemorrhoids. Hemorrhoids can cause pain to the affected person and can cause serious problems.

There are several treatments, all of which are associated with varying degrees of complications. One of the most common modern techniques is to block the blood supply artery to the anus with a ligature; thereafter, the mucosa is lifted by means of the stitches 4 to 5 and fixed in the lifted position.

An apparatus intended for the above-mentioned surgical treatment is disclosed in EP 1683473B 1. The elongated device is introduced into the rectum of a patient and allows the surgeon to ligate the artery to the rectum by using a built-in ultrasound device and access the anal mucosa via the space within the device and the openings formed in the surrounding wall of the device. In order to restore the anatomical position of the hemorrhoid, the mucosa of the rectum needs to be lifted inwards by suturing several needles by the surgeon (mucofixation). By rotating the device, the mucosa can be gradually accessed for further suturing. A total of 6 to 8 stitches were made. After suturing, a knot is tied to lift the rectal mucosa inward and the hemorrhoid is repositioned to its anatomically normal position and symptoms are alleviated.

The disclosed device assists the surgeon in suturing, but the surgeon performs the suturing by hand, which is time consuming. In addition, suturing by hand results in variations in suture depth and length, which will have an impact on the end result of the treatment. The disclosed device requires general anesthesia due to the space required when performing a needle by hand, which limits treatment to patients who can receive general anesthesia and significantly increases treatment costs.

An alternative device for the treatment of hemorrhoids is disclosed in EP 2163211. The disclosed device is intended for surgical anastomosis to produce the desired hemorrhoid treatment by excising and again anastomosing the mucosa together so as to lift the mucosa by 2cm to 3 cm. This treatment is effective, but is associated with serious complications such as post-operative pain, sepsis and even death. The costs are high due to the necessity of anesthesia and the cost of the equipment.

Accordingly, there is a need for an improved device for treating hemorrhoids that reduces procedure time, reduces treatment costs, and improves procedure outcome without the need to ligate an arterial blood supply to the rectum.

Disclosure of Invention

The present invention relates to a device for use in the treatment of hemorrhoids, which alleviates the above problems, at least to some extent, namely improved handling, faster surgical intervention and lower treatment costs.

A device for use in treating hemorrhoids, comprising:

an elongated tubular member comprising a front end and a rear end, said rear end being open such that an interior of the tubular member is accessible via the rear end, said tubular member extending along a longitudinal axis L and comprising at least one opening formed between the front end and the rear end; and

an anal mucosa support device removably arranged within the tubular element, said support device being exposed in the opening when arranged in the tubular element and comprising at least two cavities for anal mucosa arranged along the longitudinal axis L,

wherein at least one needle guide structure is formed in the elongated tubular member and the anal mucosa support device such that at least one needle is guided within the tubular member during movement through at least two cavities in the anal mucosa support device from a withdrawn position in which the needle is arranged outside the opening in the elongated tubular member to a position in which the needle extends through the opening in the tubular member.

The device according to the invention is introduced into the rectum of a patient in order to allow the surgeon to surgically treat hemorrhoids. Once the device is in the desired position, the prolapsed anal mucosa is arranged in at least two cavities in the anal mucosa support device to ensure that the anal mucosa is arranged in the correct starting position with respect to the device.

The needle guide structure formed in the elongated tubular member and the anal mucosa support device provides a reliable and efficient guide during movement of the needle within the tubular member from a withdrawn starting position through at least two cavities in the hemorrhoid support device (i.e. through the anal mucosa arranged within at least two cavities) to a position where the needle extends through the entire opening in the tubular member.

The needle is used to introduce a suture, staple or fixation device through the anal mucosa. In the specific embodiments, different alternatives for the access of sutures, staples or fixation means are described, but generally this is achieved by: the suture, staple or fixation device is introduced with the needle when the needle is moved from the retracted position to the extracted position, and then the needle is removed such that the suture, staple or fixation device is held in the desired position by the anal mucosa. Alternatively, the needle is first moved from a retracted position to an extracted position in which the needle tip is secured in a coupling element of a suture, staple or fixation means, such that the suture, staple or fixation means is introduced into the anal mucosa when the needle is retracted from a fold formed therein. Once the sutures, staples or fixation devices are properly positioned to extend through the anal mucosa, the anal mucosa support apparatus is removed from the opening and device to release the anal mucosa and the sutures, staples or fixation devices from the device, which is critical to make it possible to tension the sutures, staples or fixation devices and permanently fix the sutures, staples or fixation devices in the intended lifted position, and to remove the device from the rectum of the patient after the surgical procedure is completed.

The device according to the invention contributes significantly to the surgical treatment, since the needle guide structure and the anal mucosa support device ensure that the needle and eventually the suture, staple or fixation means extend along a desired path through a desired area of the anal mucosa arranged in each of the cavities, which ensures that the desired result is obtained. The guided needle path ensures that all surgical treatments will be performed in the correct manner as expected due to the omission of manual suturing.

In case of severe hemorrhoid problems, the rectal mucosa needs to be lifted more. The device may be further improved by increasing the number of cavities in the anal mucosa supporting device. For example, the anal mucosa support device may comprise five cavities arranged along the longitudinal axis L, such that additional folds on the anal mucosa are formed and the lifting effect is significantly improved.

In addition, several studies have shown that equally good results can be obtained by just lifting the rectal mucosa without ligating the artery supplying the rectum.

Different types of sutures, staples or fixation means may be used in connection with the device according to the invention, and when the needle and the suture, staple or fixation means are arranged to extend through the anal mucosa, the needle is removed and the suture, staple or fixation means is tensioned and permanently fixed such that the desired lifting of the prolapsed anal mucosa is achieved.

The disclosed device facilitates the surgeon in the treatment of hemorrhoids by mucofixation, with less variation in the procedure, suture depth and distance, as the needle is guided through the anal mucosa along the desired path. The device also ensures faster surgical intervention and enables surgical treatment without the need for general anesthesia, which is possible with smaller diameter devices for treating hemorrhoids and makes treatment much less costly.

The claimed device for use in treating hemorrhoids may comprise more than one opening in the tubular element arranged around the circumference of the elongated tubular element and corresponding anal mucosa support device and needle guide structure, thereby enabling surgical treatment in two or more areas within the rectum of a patient without changing the position of the device. The fact that treatment can be performed in additional areas reduces the overall time of the surgical treatment.

In an embodiment of the device, the at least one needle is moved from the extracted position substantially parallel to the longitudinal axis L to a position in which the at least one needle extends through the opening in the tubular element. This embodiment is advantageous because the surgeon is apt to control and move at least one needle via the open end of the elongated tubular member when the needle is guided substantially parallel to the axis L.

In an embodiment of the device, the at least one needle guide structure comprises at least one needle channel arranged in an opening in the elongate tubular member for guiding the at least one needle during movement from the withdrawn position to a position in which the needle extends through the opening in the tubular member. This embodiment ensures that the needle extends through the opening in the intended direction. Additional needle channels along the intended direction of the needle provide additional guidance during needle insertion.

In one embodiment of the device, the at least one needle guide structure comprises needle guide elements arranged in the elongate tubular member on each side of an opening in the tubular member to guide the needle. This embodiment is advantageous in that the needle is guided on both sides of the opening.

In one embodiment of the device, the at least one needle channel is formed in a contact surface between the elongated tubular member and the anal mucosa support device such that the at least one needle channel is opened when the anal mucosa support device is removed from the elongated tubular member. This embodiment is advantageous in that the needle and/or the suture, staple or fixation means are easily released from the device, which is necessary for withdrawing the device from the rectum of the patient.

In one embodiment of the device, the anal mucosa support device comprises a first elongated portion and a second elongated portion extending substantially parallel to the axis L, said first portion and said second portion being arranged adjacent to each other, and the at least one needle channel is formed in a contact surface between the first portion and the second portion such that the at least one needle channel is opened when the first portion and the second portion are separated from each other. This embodiment is advantageous in that the needle and/or the suture, staple or fixation means are released from the device in an efficient manner.

One embodiment of the device comprises two needle guiding structures formed in the elongated tubular member and the anal mucosa support device such that two needles are guided during movement within the tubular member from a withdrawn position, in which the needles are arranged outside the opening in the elongated tubular member, through at least two cavities in the anal mucosa support device to a position in which the needles extend through the opening in the tubular member. This embodiment is advantageous in that it provides two sutures, staples or fixation means side by side, which reduces the risk of failure, tissue/mucosa tears or a reduction of the intended lifting effect of the anal mucosa, and provides a more resistant and more resistant lifting effect.

In one embodiment of the device, the anal mucosa support device comprises a first elongated portion, a second elongated portion and an intermediate elongated portion extending substantially parallel to the axis L, said first portion and said second portion being arranged adjacent to the intermediate portion on opposite sides of the intermediate portion such that a needle channel is formed in the contact surface between the first portion and the intermediate portion and a second needle channel is formed in the contact surface between the intermediate portion and the second elongated portion such that the two needle channels are opened when the first elongated portion, the second elongated portion and the intermediate elongated portion are separated from each other. This embodiment of the anal mucosa support device provides an efficient guidance of the two needles during movement from the retracted position through the opening in the tubular element.

In an embodiment of the device, the two needle guiding structures are arranged to guide the two needles substantially in parallel through at least two cavities in the anorectal support device from the extracted position, in which the needles are arranged outside the opening in the elongate tubular member, to a position in which the needles extend through the opening in the tubular member. In addition, the two needles are guided in a direction substantially parallel to the longitudinal axis, which is advantageous as it facilitates the insertion and movement of the needles by the surgeon via the open end of the tubular element.

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

One embodiment of the apparatus comprises: a sealing plug arranged to close and seal the open rear end of the apparatus; and a connection having access to the interior of the tubular element, said connection being intended to be connected to a pumping device such that the pressure inside the tubular element can be reduced and the anal mucosa is sucked into the at least two cavities to assist in the treatment of the patient. The pumping means is for example a manual or electric pump or an externally arranged suction source, so that the anal mucosa can be sucked into at least two cavities of the device.

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

In one embodiment of the device, the device comprises a handle extending in a substantially radial direction with respect to the longitudinal axis L from the rear end of the tubular element, and a connection having a passage to the interior of the tubular element is arranged in the handle.

In an embodiment of the device, at least two cavities in the anal mucosa support device comprise a bottom structure and the distance in radial direction from the axis L between the centre of the needle channel and the bottom structure is between 2mm and 12 mm. This embodiment provides a reliable fixation once the suture, staple or fixation means are tightened and permanently fixed, since the folds of the anal mucosa will have sufficient strength and will not break.

In an 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 advantageous because the anal mucosa will be sucked towards the base structure, thereby ensuring that the suture depth in the anal mucosa is the same in each operation.

In an embodiment of the device, the at least two cavities in the anal mucosa support device comprise a bottom structure, and the cavity arranged in the front end of the anal mucosa support device along the axis L is at a larger distance from the axis L in the radial direction between the centre of the needle passage and the bottom structure than at least one other cavity. This embodiment provides a secure fixation once the suture, staple or fixation means is tightened and permanently fixed, since the fold in the inner end of the treated area will be larger than the other fold or folds and thereby provides a secure fixation of the anal mucosa folds and ensures the desired inward lifting of the anal mucosa.

In one embodiment of the device, the anal mucosa support device is held in a desired position within the tubular element by removably arranging a locking element within the tubular element to push the anal mucosa support device into the desired position and the at least two cavities are exposed in the opening of the tubular element. This embodiment is advantageous in that the anal mucosa support device may be moved radially inwards when the locking element is removed and easily removed from the opening of the tubular element.

In one embodiment of the device, the locking element forms the bottom surface of the cavity in the anal mucosa support device. This embodiment provides a device which is less complex in construction and ensures that the device will function as intended.

One embodiment of the device comprises at least one closure element removably arranged in the tubular element to close at least one opening in the tubular element and facilitate insertion of the device.

In one embodiment of the device, the closure element has a shape corresponding to the shape of the tubular element to provide a smooth outer surface of the device and to facilitate insertion of the device.

Drawings

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

fig. 1 shows a perspective view of the apparatus according to the invention.

Fig. 2 shows an exploded view of the device of fig. 1.

Fig. 3 shows a cross-sectional view transverse to the longitudinal axis L of the device.

Figure 4a illustrates selected portions of the device of figure 1 prior to insertion of a needle.

Figure 4b shows selected parts of the device after the needle has been inserted.

Figure 4c illustrates selected portions of the device of figure 1 with an insertion needle.

Figure 4d illustrates selected portions of the device of figure 1 after the needle has been inserted and the first portion of the mucosal support device has been removed.

Figure 4e shows selected parts of the apparatus of figure 1 during tightening of the fastening means.

Fig. 5 shows a second embodiment of the device according to the invention in a perspective view.

Fig. 6 shows an exploded view of a second embodiment of the device according to the invention in a perspective view.

Fig. 7 illustrates a cross-sectional view of the second embodiment of the apparatus through a plane transverse to the longitudinal axis.

Figure 8 illustrates selected portions of a second embodiment of the apparatus.

Fig. 9 schematically shows the use of sutures to lift the anal mucosa.

Fig. 10 schematically shows a second embodiment for lifting the anal mucosa using sutures.

Fig. 11 schematically shows a third embodiment for lifting the anal mucosa using sutures.

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

Detailed Description

As previously mentioned, the present invention is directed to a device 10 for use in treating hemorrhoids. The device comprises an elongated tubular member 12 forming a housing of the device. The tubular element 12 comprises a rounded front end 13 intended to be arranged in the rectum of the patient. The tubular element further comprises an open rear end 14 intended to be arranged outside the rectum of the patient during use of the device. The rear end 14 is slightly curved outwardly. Inside the tubular element, an internal cavity is formed, accessible via the open rear end 14. The tubular element is substantially straight and extends along a longitudinal axis L. The tubular element can be made in different lengths and the cross-sectional shape of the tubular element transverse to the axis L is substantially circular in order to facilitate the insertion of the device at the start of the treatment. Alternative cross-sectional shapes are also rounded ovals, triangles, rectangles, pentagons or hexagons, etc. The tubular element is preferably made of a plastic material.

The tubular element further comprises at least one opening 15 (illustrated in fig. 2) formed in the tubular element wall and arranged between the front end 13 and the rear end 14. The openings 15 have substantially the same width transverse to the axis L and extend between a front end and a rear end. In addition, a handle 16 extends from the rear end of the tubular element in a substantially radial direction with respect to the axis L, in order to facilitate moving the device during use. It is within the scope of the invention to provide additional handles and to modify the design of the handle in different ways.

The device 10 further comprises an anal mucosa support device 20 (e.g. as shown in fig. 2). The illustrated embodiment of the anal mucosa support device comprises a first elongated portion 21 and a second elongated portion 22, which are arranged to extend substantially parallel to the axis L. The first elongated portion and the second elongated portion are arranged adjacent to each other and are intended to be removably arranged within the tubular element such that the anal mucosa support device 20 is exposed in the opening 15 in the tubular element 12 when arranged in the intended position within the tubular element. The anal mucosa supporting device comprises at least two cavities 23 for the anal mucosa, but the illustrated embodiment comprises four cavities 23 of substantially equal size and a larger fifth cavity 24, which is formed by the front end of the anal mucosa supporting device when it is arranged in the intended position in the tubular element 12. The cavities 23, 24 are arranged substantially centrally of the opening in the tubular element along the longitudinal axis L. Each cavity has an open side facing the opening 15 in the tubular element 12 so that the anal mucosa can enter each cavity.

The first and second elongated portions 21, 22 are designed to be arranged adjacent to each other substantially in the centre of the opening, and each of the cavities 23, 24 is arranged along the contact surface between the first and second elongated portions 21, 22, such that the cavity is formed by substantially the same half of the first and adjacent second elongated portions, i.e. half of the cavity is formed by one of the elongated portions and the other half of the cavity is formed by the other elongated portion. In addition, a needle passage 25 is formed along a contact surface between the first portion and the second portion. The illustrated embodiment of the device comprises four needle passages 25, one between each of the cavities in the anal mucosa support device. When the first and second portions are separated from each other, the needle passage 25 is opened to release a needle, or a suture, staple or fixation device, extending through the needle passage 25.

The needle channel 25 constitutes a needle guiding structure formed in the elongated tubular member 12 and the anal mucosa support device 20 such that the needle 100 is guided during movement of the needle inside the tubular member through the lumen in the anal mucosa support device from a withdrawn position, in which the needle is arranged outside the opening 15 in the elongated tubular member 12, to a position in which the needle extends through the opening in the tubular member. Each needle passage 25 has a size and shape corresponding to the cross-sectional size and shape of the needle so that the needle can easily pass through each needle passage when the needle moves from the retracted position to the extracted position. Preferably, the side of the needle channel facing the rear end of the device is slightly widened to guide the needle into the center of the needle channel 25.

Each cavity 23, 24 in the anal mucosa support device 20 comprises a bottom structure 26 and the distance in the radial direction from the axis L between the centre of the needle passage and the bottom structure is between 2mm and 12 mm. In order to ensure that the anal mucosa is correctly arranged in the cavities 23, 24 in the anal mucosa support device 20, the bottom structure of each cavity comprises at least one opening 27 in each cavity, said opening 27 being connected to some means capable of providing a pressure below ambient pressure, such as a manual or electric pump or a suction source arranged externally, so that the anal mucosa is sucked into the cavity.

The anal mucosa support device 20 is removably arranged within the tubular element 12 and is held in a desired position within the tubular element by a removable locking element 30. The locking element is shaped like an elongated plate 31, the length along the axis L, and the width corresponding to the inner dimensions of the elongated tubular element. The positioning and fixation of the locking element within the tubular element is provided by rails 32 arranged along the inner circumferential wall of the tubular element on each side of the opening in the tubular element, so that the locking element can slide parallel to the longitudinal axis L. The first and second elements of the anal mucosal support fit within the recesses 37 on the side of the locking element facing the opening 15 in the tubular element, so that the first and second elements 21, 22 remain in the desired position. A locking element 30 is arranged inside the tubular element to push the anal mucosa support device 20 into the desired position and to hold the anal mucosa support device in the desired position with the cavity exposed in the opening of the tubular element. In the illustrated embodiment of the anal mucosa support device and locking element, the cavity has an open bottom structure which is closed by the locking element 30.

In the above description of the device 10, only one arrangement comprising one opening 15 in the tubular element 12, one anal mucosa supporting device 20 and one locking element 30 is described, but preferably the device 10 is designed to comprise two, alternatively three or up to six similar, corresponding substantially identical arrangements, each comprising one opening in the tubular element, one anal mucosa supporting device and one locking element. If the device comprises two arrangements (illustrated in fig. 3), the openings are arranged opposite each other in the tubular element, and if the device comprises three or more arrangements, the arrangements are arranged at substantially equal distances from each other around the tubular element.

The device 10 is introduced into the rectum of a patient in order to allow the surgeon to surgically treat hemorrhoids. Once the device is in the desired position, the prolapsed anal mucosa is arranged in the cavity 23, 24 in the anal mucosa support device 20. The needle guiding structure formed in the elongated tubular member and the anal mucosa support device provides guidance during the movement of the one or more needles 100 within the tubular member from a withdrawn starting position through the lumens 23, 24, i.e. through the anal mucosa arranged within the lumens, to a position where the needle 100 extends through the entire opening 15 in the tubular member 12 and through the anal mucosa arranged within the different lumens such that a fold is created in the anal mucosa.

The needle 100 is used to introduce sutures, staples or fixation devices through the various folds of the anal mucosa. Different alternatives for the entry of sutures, staples or fixation devices may be used. The suture, staple or fixation means is introduced together with the needle or the needle is first moved from a retracted position to an extracted position in which the needle points are fixated in corresponding abutment elements 122 in the end of the suture, staple or fixation means arranged within the front end of the device, as illustrated in fig. 10 and described in detail later in this description. When the needle is retracted from the extracted position and the suture, staple or fixation device is pulled through the anal mucosa, the suture, staple or fixation device is introduced into the anal mucosa. Once the sutures, staples or fixation means are properly positioned, the anal mucosa holding device 20 is removed from the opening and removed from the device 10 via the open back end 14 to release the anal mucosa and the sutures, staples or fixation means from the device, which is essential to make it possible to remove the device from the rectum after the sutures, staples or fixation means are tightened and permanently fixed.

The device 10 according to the invention facilitates surgical treatment, since the needle guide structure and the anal mucosa support device 20 ensure that the needle 100 and eventually the suture, staple or fixation means extend through the desired area of the anal mucosa arranged in each of the cavities 23, 24, which ensures that the desired result is obtained.

In case of severe hemorrhoid problems, the rectal mucosa needs to be lifted more. The device can be further improved by increasing the number of cavities in the anal mucosa supporting device such that additional folds in the anal mucosa are formed, which results in a significantly improved lifting effect.

The device 10 further comprises one closing element 40 for each opening 15 in the tubular element 12. The closing element 40 has a shape corresponding to the cross-sectional shape of the tubular element 12 to provide a smooth outer shape of the device 10 and a length corresponding to the length of the opening 15 to completely close the opening when arranged in the device. A closure element is removably arranged in the tubular element and is intended to close an opening in the tubular element in order to facilitate insertion of the device into the rectum of a patient. When the device is in the desired position in the rectum, the closing element extending up to the rear end of the device is removed via the rear end 14 of the tubular element 12 to expose the opening in the tubular element and to allow access to the cavity by the anal mucosa. The closure element 40 is arranged to slide in a substantially straight recess 42 (illustrated in fig. 3) formed along the elongate side of the opening 15 in the tubular element, substantially parallel to the longitudinal axis L. In the illustrated embodiment of the tubular element and closure element, the closure element exits the tubular element via a slot 43 in the curved section in the rear end 14 of the tubular element 12. The slot has a shape corresponding to the shape of the closing element.

When the device is fitted in the desired position in the rectum of the patient and the closure element is removed, the open rear end 14 of the tubular element 12 is closed by the sealing plug 50. The locking element 30 and the anal mucosa support 20 terminate at the open rear end 14 of the tubular element 12, and a sealing plug 50 is designed to fit in the open rear end 14 and to close and seal the open rear end 14 of the device 10, so that a pumping or suction means can be connected to the interior of the tubular element 12 via a connection 51 in said sealing plug 50. The sealing plug may also be provided with a resilient tube extending from the plug to facilitate connection to a pumping or suction device. Alternative embodiments providing the desired connection of the pumping or suction means to the interior of the tubular element are also possible. For example, the pumping or suction means may be connected to the interior of the device via a connection (not shown) arranged on the rear end or handle of the device and a passage integrated in the device and connected to the interior of the tubular element 12. When the pumping or suction device (not shown) is activated, the pressure inside the tubular element 12 is reduced and the anal mucosa is sucked into the cavity.

Once the anal mucosa is in the desired position within the cavities 23, 24, the needle 100 is pushed from the retracted position through the needle passage 25, through the cavities 13, 14 and the anal mucosa arranged therein, up to the opposite side of the opening 15 in the tubular element 12.

The needle 100 extends through the needle cannula 101 (shown in fig. 2) substantially parallel to the longitudinal axis L. The needle cannula 101 is intended to be arranged in the space behind the opening 15 in the tubular element 12 formed by the first cannula support 28 in one of the elongated portions 22 and the corresponding adjacent second cannula support 29 in the other elongated portion 21. The cannula 101 is intended to hold and support the needle 100 in a desired position within the tubular element of the device 10 and to guide the needle 100 during movement from the retracted position through the opening 15. The cannula 101 is designed to provide a tight fit with the exterior of the needle and the first and second cannula supports 28, 29 are designed to provide a tight fit with the needle cannula to prevent air from leaking from the surrounding space into the enclosed space within the tubular element through the gaps between the needle and the needle cannula and between the needle cannula and the first and second cannula supports 28, 29.

Allowing the needle to move back and forth within the cannula 101. When the locking element 30 and the anal mucosa support device 12 are removed from the tubular element, the needle cannula 101 is released and either removed or used to facilitate tensioning of sutures, staples or fastening means to secure the anal mucosa in the lifted position.

In fig. 4a, a perspective view of the device 10, the opening 15 in the tubular element and the anal mucosa support device is shown before the needle is moved. The device comprises four equally sized cavities 23 and one larger cavity 24 arranged in the front end of the anal mucosa support device and in the opening of the tubular element. Each of the cavities comprises a bottom structure 26, and the cavity arranged in the front end of the anal mucosa support device along the axis L is at a greater distance from the axis L in the radial direction between the centre of the needle passage and the bottom structure than the other cavities to create a stronger and more resistant fixation in the larger inner folds of the anal mucosa.

In fig. 4b, 4c and 4d, perspective views of the anal mucosa support device and the needle moved to a position where the needle extends through the cavity are shown. The anal mucosa is not shown in order to show the anal mucosa support device and the needle more clearly. In fig. 4d, one elongated portion 21 of the anal mucosa support has been removed in order to more clearly show the needle and the needle channel 25 formed between the first and second elongated portions. In fig. 4e, the first and second elongated portions 21, 22 of the anal mucosal support and the locking element 30 are removed.

The claimed device for use in treating hemorrhoids may comprise more than one opening in the tubular element and corresponding anal mucosa support device and needle guide structure, thereby making it possible to perform surgical treatment in two or more areas within the rectum of a patient without changing the position of the device. The fact that treatment can be performed in additional areas reduces the overall time of the surgical treatment.

Alternative embodiments of the device according to the invention are shown in fig. 5, 6, 7 and 8. This embodiment comprises two needle guiding structures formed in the elongated tubular member and the anal mucosa support device such that two needles may be guided during movement of the needles within the tubular member from a withdrawn position, in which the needles are arranged outside the opening in the elongated tubular member, through at least two cavities in the anal mucosa support device to a position in which the needles extend through the opening in the tubular member. This embodiment is advantageous in that it provides two sutures, staples or fixation devices side by side, which provides an improved lifting effect when the sutures, staples or fixation devices are tensioned, and a more resistant and more powerful lifting effect.

This embodiment of the device 10 "comprises an elongated tubular member 12" of the same type, having a rounded front end 13 "and a slightly curved open rear end 14", preferably removably connected to the body of the tubular member so as to facilitate assembly of the different components of the device. The length, cross-sectional shape and diameter may be adapted to suit different patients.

In the tubular element, an opening 15 "of the same type is formed between the front end 13" and the rear end 14 ". The opening 15 has a substantially constant width along a direction parallel to the axis L.

Anal mucosa support device 20 "comprises a first elongated portion 21", a second elongated portion 22 "and an intermediate elongated portion 215", which portions are arranged to extend substantially parallel to axis L.

The first and second portions are arranged adjacent to the intermediate portion on opposite sides of the intermediate portion such that one needle channel 251 "is formed in the contact surface between the first portion and the intermediate portion and a second needle channel 252" is formed in the contact surface between the intermediate portion and the second elongated portion.

The anal mucosa support device 20 "is removably arranged within the tubular element such that the anal mucosa support device 20" is exposed in the opening 15 ". The anal mucosa support device comprises four cavities 23 "of substantially equal size and a fifth, larger cavity 24" formed in the front end.

The first, second and intermediate portions are designed to be arranged adjacent to each other, and a first needle channel 251 "and a second needle channel 252" are formed along the contact surfaces between the first and intermediate portions and the intermediate and second portions. The illustrated embodiment of the device includes five needle channels. The needle channel constitutes a needle guiding structure providing the desired guidance of the respective needle 1001 ", 1002" during its movement through the cavity from the extracted position within the tubular element.

The anal mucosa support device is removably arranged within the tubular element and is held in a desired position within the tubular element by a removable locking element 30 ", as described above in relation to the first embodiment of the device. In the same way as described above, the device according to the invention comprising the anal mucosa support device and one locking element has been described, but the device may comprise two, alternatively three or more corresponding substantially identical arrangements. If the device comprises two arrangements (illustrated in fig. 3), the openings are arranged opposite each other in the tubular element, and if the device comprises three or more arrangements, the arrangements are arranged at substantially equal distances from each other around the tubular element.

Different types of sutures, staples or fixation means may be used in connection with the device according to the invention, and when the needle and the suture, staple or fixation means are arranged to extend through the anal mucosa, the needle is removed and the suture, staple or fixation means is tensioned and permanently fixed such that the desired lifting of the prolapsed anal mucosa is achieved.

In the drawings, different embodiments of the device according to the invention are shown. However, the various components of the device may be modified in various ways without departing from the scope of the invention as defined by the appended claims.

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

A first alternative is schematically illustrated in fig. 9. At the front end of the device 10, a front stop element 110 is removably arranged in front of the opening 15 in the tubular element 12 before starting the treatment. The needle comprises a needle tip 102 and a needle body 103 shaped like a tube. The needle tip is releasable from the needle body and a suture 104 having a length exceeding the length of the needle body extends through the needle body from the back end of the needle body to the needle tip 102, wherein the suture is permanently fixed in the needle tip 102. The stop element 110 is positioned at a desired forward position of the needle tip 102. When the device 10 is in the desired position within the rectum of the patient, the needle is moved from the retracted position through the cavity to the front stop element 110, with the needle tip 102 penetrating the front stop element 110 and permanently secured to the front stop element 110. The permanent fixation between the front stop element and the needle tip can be achieved in different ways, for example a male/female fitting. The needle body 103 is then retracted to release the suture 104 extending through the anal mucosa. Once the needle body is removed, the sealing plug 50, the locking element 30 and the anal mucosa holding device 20 are also removed to release the thread and the anal mucosa from the anal mucosa holding device. To achieve the desired lifting of the anal mucosa, the rear stop element 111 is pushed forward along the line to push the anal mucosa fold towards the front stop element 110. The backstop element 111 and suture 104 are either provided with corresponding securing structures preventing rearward movement of the backstop element 111 along the thread, or are permanently fixed in the desired position by, for example, a knot. The rear stop element 111 is either arranged on the thread before starting the treatment and positioned in front of the needle cannula 101 or on the thread once the needle body and the needle cannula are removed from the thread.

A second alternative is shown in figure 10. Within the front end of the device 10, a suture 120 is disposed within the device prior to beginning treatment. The front stop element 121 is permanently fixed at one end of the suture and the abutment 122 (e.g. a ring or male/female fitting) is arranged at the opposite end of the suture. The docking device 122 is positioned at a desired forward location of the needle tip 102. When the device 10 is in a desired position within the rectum of a patient, the needle 100 is moved from the retracted position through the cavity to the docking arrangement 122, wherein the needle tip 102 is connected to the docking arrangement 122 such that the needle is connected to the docking arrangement 122. The needle is then retracted with the suture to a position where the front stop element 120 abuts the front fold of the anal mucosa. Once the needle is removed, the sealing plug 50, the locking element 30 and the anal mucosa holding device 20 are also removed to release the thread 120 and the anal mucosa from the anal mucosa holding device. To achieve the desired lifting of the anal mucosa, the rear stop element 123 is pushed forward along the line to push the anal mucosa fold towards the front stop element 121. The backstop element 123 and suture 120 are either provided with corresponding securing structures preventing the backstop element 123 from moving backwards along the thread, or are permanently fixed in the desired position by e.g. a knot. Once the needle and needle cannula are removed from the wire, a rear stop element 123 is arranged on the wire.

A very simple and reliable embodiment based on this general concept comprises an elongated suture arranged to be loaded within the device before starting the surgical procedure. The suture includes a docking element 122 on the end. Once the needle is introduced, the needle tip is connected to the docking element 122 and when the needle is retracted, the wire is introduced through the anal mucosa. The length of the suture is at least long enough to ensure that both ends of the suture extend all the way out through the open end of the device so that the surgeon can secure the ends of the suture by one or more knots and lift the anal mucosa.

This embodiment is also very advantageous in combination with the embodiment of the device comprising two parallel needles, since one single suture may be arranged in the front end of the device, one end of the suture being provided with the abutment 122 of one needle positioned in the front end, and the second end of the suture being provided with a similar abutment 122 of the other needle positioned in the front end. Once the two needles have been docked to the corresponding docking means 122, the two ends of the suture are retracted through the folds of the anal mucosa so that both ends extend out of the rear end of the device. After the desired lifting of the anal mucosa has been achieved, the two ends may be secured by one or more positive knots.

A third alternative is shown in fig. 11. At the front end of the device 10, a front stop element 130 is removably arranged in front of the opening 15 in the tubular element 12 before starting the treatment. A suture 131 extends from the front stop element 130 to the rear end of the tubular element 12. The needle comprises a needle tip 102 and a needle body 103 shaped like a tube. The needle tip is releasable from the needle body and a suture 132 having a length exceeding the length of the needle body extends through the needle body from the rear end of the needle body to the needle tip 102, wherein the suture is permanently secured in the needle tip 102. The stop element 130 is positioned at a desired forward position of the needle tip 102. When the device 10 is in the desired position within the rectum of the patient, the needle is moved from the retracted position through the cavity to the front stop element 130, with the needle tip 102 penetrating the front stop element 130 and permanently secured to the front stop element 130. The permanent fixation between the front stop element and the needle tip can be achieved in different ways, for example a male/female fitting. The needle body 103 is then retracted to release the suture 132 extending through the anal mucosa. Once the needle body is removed, the sealing plug 50, the locking element 30 and the anal mucosa holding device 20 are also removed to release the thread 132 and the anal mucosa from the anal mucosa holding device. The anal mucosa arranged along the line is pushed forward along the suture 132 to push the anal mucosa fold towards the forward stop element 130. The suture 132 extending from the needle tip 102 and the suture 131 extending from the anterior stop element 130 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 aforementioned alternatives. This alternative is not shown in any of the figures. Within the front end of the device 10, a suture is placed before treatment is initiated. Near the center of the suture, the front stop element is permanently fixed to the suture. One end of the suture is brought to a position outside the rear end of the device. The other end of the suture is terminated by a docking means (e.g. a ring or male/female fitting) arranged in a position in front of the needle tip. When the device is in a desired position within the rectum of a patient, the needle is moved from the retracted position through the cavity to the docking arrangement, wherein the needle tip is connected to the docking arrangement. The needle is then retracted with the suture to a position in which the front stop element abuts against the front fold of the anal mucosa. Once the needle is removed, the sealing plug, the locking element and the anal mucosa holding device are also removed to release the thread and the anal mucosa from the anal mucosa holding device. The anal mucosa arranged along the line is pushed forward along the suture line to push the anal mucosa fold towards the front stop element. The two portions of suture extending from the front stop element are then secured together by one or more knots to secure the anal mucosa in the lifted position.

A fifth embodiment (not shown) comprises a front stop element arranged in front of the opening of the tubular element. The needle includes a needle tip and a needle body shaped like a tube. Once the needle has been introduced all the way to the front end of the tubular element, the suture is pushed forward via the needle body towards a guide surface within the front end of the tubular element, so that the direction of the suture is changed, and when the suture is pushed further into the tubular element, the front end of the suture is moved back towards the open rear end of the tubular element. Once the desired lifting of the anal mucosa is achieved, the leading and trailing ends of the suture are secured together by, for example, a knot.