HK1123475B - A device for surgical treatment of rectal and haemorrhoidal prolapse - Google Patents

Description

Device for the surgical treatment of rectal and haemorrhoidal prolapse

Technical Field

The present invention relates to a method and a device for the surgical treatment of rectal and haemorrhoidal prolapse.

The invention is applicable in the field of surgical operations related to rectal pathologies, in particular with the aim of treating and/or reducing rectal and haemorrhoidal prolapse.

Background

As is well known, the development of hemorrhoidal diseases is caused by physiological changes in the cavity of the anal canal, formed by the vascular space, the arterio-venous shunt and the saccular venous structure constituting the internal haemorrhoidal plexus. In more detail, the internal haemorrhoidal plexus is a blood space of a few millimetres calibre defined by a vein or capillary endothelium inside a connective tissue covered by the rectal mucosa. These structures are supported by anchoring fibers to the internal sphincter, which form the Treitz or Parks ligament.

The lumen receives only arterial flow from the distal branch of the upper rectal artery, the nature of which results in a treatment suitable for the most recent treatment procedure.

The development of surgical techniques in this field is in continuous evolution, since, where possible, especially according to the prior art, it is sought to make these surgical wounds as small as possible, which often lead to serious risks and complications for the patients who undergo this type of surgery.

In particular, in the past, the principle surgical technique was based on the removal of tissue, i.e. the surgical removal of the portion of the rectal mucosa affected by the pathology.

Such procedures include the removal of the haemorrhoidal prolapse while suturing the relevant (interesting) area.

Such procedures are described in detail in patent document WO 01/21060, which exemplifies the necessary kits for transanal surgery and procedures for its use.

In detail, such operations involve acting on the mucous wall of the rectal wall, in particular on the part of the mucous wall affected by the haemorrhoidal prolapse, by providing a ring or annular structure similar to a smoke pouch. This is done by circular stitching the suture several times until it progresses along the circumference of the ampulla of the rectum affecting the entire prolapse, while achieving a circular protrusion (intussusion) towards the inside of the ampulla of the rectum.

The annular extrusion thus achieved is subsequently cut off, while the remaining bundle-like edge of the mucus wall is sewn.

The device for performing this operation comprises a semi-cylindrical body connected to a handle which can be gripped and inserted into the anus of the patient, for example using an anatomically tapered introducer. The semi-cylindrical body exhibits, at its front end, an opening which intersects a portion of the haemorrhoidal prolapse and carries out its compression inside the semi-cylindrical body. The device also comprises a mechanical suturing device behind the semi-cylinder for cutting the annular protrusion by means of a cylindrical blade and suturing the closed-to edge of the rest of the mucosa by means of a heated metal wrapping (stable) inside the edge.

This type of procedure is necessarily very traumatic.

In particular, despite good results and prevention of prolapse in general, the procedure causes considerable post-operative pain and requires hospitalization of the patient, and may also pose greater post-and intra-operative risks.

Different interventional techniques, commonly known as assisted surgical techniques, have also been studied with the aim of reducing the serious drawbacks of traditional surgery. These techniques include, for example, elastic ligation of the hemorrhoidal tissue, simultaneously compressing the hemorrhoid by elastic ligation at the point where it is attached to the mucous wall of the rectal tract, and allowing its physiological prolapse without relying on excision of the hemorrhoidal tissue. Another example of an assisted surgical technique is sclerotherapy, which necroses the relevant (interesting) part by injecting sclerosant solution.

Other examples of adjuvant surgical techniques include infrared photocoagulation, cryotherapy, or laser therapy.

Some of these adjuvant surgical treatments use devices of the type described in patent WO 2004/064624. The device comprises a cylindrical body acting as a divavicator, displaying clamps and an opening in a lateral position for intercepting and observing the haemorrhoidal prolapse. In the vicinity of the opening, the cylindrical body comprises a seat for housing a probe (in particular an ultrasound probe) which is able to detect the vicinity of the blood vessel in order to enable correct direct intervention on the area actually affected by the haemorrhoidal prolapse, even where this area has poor visibility and/or accessibility. The device also comprises means for illumination, which can be associated with the clamp, for illuminating the region of intervention interest and, if necessary, for illuminating the inside of the cylinder. In particular, devices of the above type are used to create surgical opportunities in the distal portion of the superior rectal artery, which includes the haemorrhoidal prolapse, by ligation in the area surrounding the artery (while using a curved suture needle), followed by compression (ping) of the area where the prolapse occurs due to interruption of blood flow.

However, this technique does not in itself reduce the presence of haemorrhoidal prolapse inside the anal canal in a short time.

Disclosure of Invention

It is therefore the technical aim of the present invention to provide a method and a device for performing surgical operations on rectal and haemorrhoidal prolapse which overcome the above mentioned drawbacks.

The main object of the present invention is to provide a method and a device for performing surgical operations on the rectum and on the haemorrhoidal prolapse, which reduce the haemorrhoidal prolapse internally of the rectum for a short period of time.

It is another object of the present invention to provide a method and device for performing surgical operations on rectal and haemorrhoidal prolapse which reduces post-operative complications and post-operative pain.

Another important object of the present invention is to provide a method and a device for performing surgical operations on rectal and haemorrhoidal prolapse which limit the need for the patient to use anaesthetics, or in any case to perform anaesthesia as locally as possible.

The above and other objects are substantially achieved by a method and a device for performing surgical operations on rectal and haemorrhoidal prolapse according to the appended claims.

Drawings

Preferred embodiments of the process and of the device for surgical operations on rectal and haemorrhoidal prolapse will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

fig. 1 is a schematic longitudinal cross-sectional view of the anal canal;

FIG. 2 is a side view of the apparatus of the present invention;

FIG. 3 is a perspective view of a first portion of the device of FIG. 2;

FIG. 4 is a plan view of a first portion of the apparatus of FIG. 2;

FIG. 5 is a cross-sectional view of a first portion of the device of FIG. 2;

FIG. 6 is a side view of a second portion of the device of FIG. 2;

fig. 7 is a perspective view of a second portion of the device of fig. 2.

Detailed Description

The preferred embodiment of the method and device for the surgical operation of rectal and haemorrhoidal prolapse according to the present invention comprises the following phases:

at least a first circular stitching (stabbing) 1 is realized at the position of the recto-haemorrhoidal prolapse 2, for example with a stitching thread 6;

-realising at least a second circular stitching 4 at the same position, i.e. at the haemorrhoidal prolapse 2;

-approaching the first and second circular stitching 1, 4 in order to form a constriction of the haemorrhoidal prolapse 2.

Advantageously, the first circular stitching 1 and the second circular stitching 4 are formed at a first portion 2a and a second portion 2b, respectively, of the haemorrhoidal prolapse 2, which are located in the vicinity of the ends of the terminal tract (track) of the rectum 5 in figure 1, and develop towards a main direction X. In addition, the first portion 2a of the prolapse 2 is deeper inside the rectum 5 than the second portion 2 b. This provides particular advantages, as better evident from the following description.

Circular sutures are formed with different suturing members.

In the embodiment of fig. 1, a line 6 is preferred and shown, which line 6 will be referred to hereinafter as suture 6.

The suture 6 is wound several times around the haemorrhoidal prolapse 2, said haemorrhoidal prolapse 2 protruding from a wall 7 of the rectum 5 towards the inside of the rectum 5 itself and towards the anus 8 of the rectum 5. In the schematic view of fig. 1, the suture 6 is partially inserted inside the tissues constituting the wall 7 of the rectum 5, in particular inside the tissues defining the haemorrhoidal prolapse 2. Insertion of the suture 6 into the tissue is preferably carried out with a sharp body, such as a needle, which is not shown, since it is of a known type.

Preferably, the step of realising the first circular stitching 1 is carried out by inserting the first end 9 of the stitching thread 6 in the first portion 2a of the haemorrhoidal prolapse 2. The realisation of the second circular stitching 4 is preferably carried out with the same stitching thread 6, in the same way, by inserting the first end 9 of the stitching thread 6 in the second portion 2b of the haemorrhoidal prolapse 2. The suture 6 in this configuration and like in fig. 1 shows that the first end 9 is at the location of the second circular stitching 4, while at the same time it shows that the free second end 10 is at the location of the first circular stitching 1. The above method has a curved needle at the first end of suture 6.

The stage of realising the first circular stitching 1 advantageously also comprises a stage of realising a further circular stitching 11. Another circular stitching 11 is realised at a third portion 12 of the haemorrhoidal prolapse 2, said third portion 12 being located between the first portion 2a and the second portion 2 b. Fig. 1 shows two further circular stitchings 11 which are located between the first circular stitchings 1 and the second circular stitchings 4. Each circular stitch 1, 4, 11 is preferably realized with one stitch 6.

Moreover, each circular stitch 1, 4, 11 of the suture 6 advantageously affects the peripheral branch of the rectal artery 13 associated with the haemorrhoidal prolapse 2, with the result that the peripheral branch can subsequently be contracted, the technique of which will be explained below.

In particular, the curved needle is operated and guided to perform a trajectory (track) inside the tissue of the haemorrhoidal prolapse 2, which constrains the distal branch of the rectal artery 13 so as to finally form, when the curved needle is reproduced from the tissue, a loop inside which the distal branch of the above-mentioned rectal artery 13 is contained. Each stage of realisation of the circular stitches 1, 4, 11 therefore comprises a stage of realisation of at least one loop connected to a terminal branch of the rectal artery 13 associated with the rectal pathology.

In the method of the invention and in the preferred embodiment shown in figure 1, each ring is contained in a plane perpendicular to the main development direction X of the haemorrhoidal prolapse 2. This is advantageous because each stage of realising the circular stitchings 1, 4, 11 also comprises a stage of shrinking the respective circular stitchings 1, 4, 11. Each loop, once completed, is subjected to a hand pulling action, preferably on suture 6. This is much simpler by placing the individual rings as described above, since only a lateral restriction is achieved with respect to the development of the rectal artery 13, while no change in the axial direction is induced.

Pulling the suture 6 has the purpose of achieving a restriction of a portion of the haemorrhoidal prolapse 2 (and therefore of the corresponding artery of the rectal artery 13) associated with a single ring, and of causing a disruption of the blood flow in the artery, causing its prolapse at the same time.

The stages of forming the circular stitchings 1, 4, 11 are preferably carried out by realising the circular stitchings 1, 4, 11 in a substantially superimposed position along the main development direction X of the haemorrhoidal prolapse 2. This results in an ordered sequence of rings as described in the configuration of fig. 1, in which a single ring "pocket" sequentially surrounds the haemorrhoidal prolapse 2.

After the completion of the circular stitching 1, 4, 11 phases, it is advantageous to have a phase of reciprocal approach to the first circular stitching 1 and to the second circular stitching 4, in order to achieve a limitation of the haemorrhoidal prolapse 2 also along the main development direction X of the haemorrhoidal prolapse 2. This achieves a significant reduction in the overall size of the haemorrhoidal prolapse 2 inside the rectum 5.

The phase of approximating the circular sutures 1, 4 is preferably performed by knotting the suture thread 6. The knotting phase comprises a phase in which one or more successive knots are obtained, thus stabilizing the anterior approach of the circular sutures 1, 4.

Advantageously, moreover, the method of the invention may comprise a stage of forming a further circular stitching, in particular a "main circular stitching", a portion of which is shown in figure 1 and indicated by the reference 14, which serves as a reference for the final suture thread 6 income.

This phase, which is preferably performed before the realisation of the first circular stitching 1, is performed by forming at least one loop in a portion of the wall of the rectum 5, which is not included in the haemorrhoidal prolapse 2. The realization of the main circular suture 14 has the purpose of defining an anchor for subsequent access to the circular sutures 1, 4, as better clarified herein below.

It is also preferred that the main circular stitching 14 is realized by means of a stitching thread 6 used for realizing the circular stitching 1, 4, 11. The main circular stitching 14 is also preferably realised in a portion of rectum 5 located at a greater depth, and therefore at a higher level, with respect to the anus 8 than the haemorrhoidal prolapse 2, as shown in figure 1. The main circular stitching 14 is thus also located at a deeper position than the first circular stitching 1, since the above is stated with reference to the first circular stitching 1 and the second circular stitching 4.

In detail, the second end 10 of the suture 6, at the location of the first circular stitching 1 and therefore at the location of the main circular stitching 14, is partially folded so as to define a slit, indicated with 15 at the beginning of the formation phase. The first end 9 of the suture 6 can be inserted inside the slit 15 and can start the phase of approaching the circular stitches 1, 4 by pulling the suture 6; the knotting phase, which defines the stable approximate position of each circular suture, is then initiated.

The stages of the aforementioned restraining haemorrhoidal prolapse 2 also raise the haemorrhoidal prolapse 2 towards the main circular stitching 14 and deep into the rectal artery 5 (as can be seen in the right area of figure 1, said figure 1 showing the restraining and raising of the treated haemorrhoidal prolapse 2). This provides the advantage of spacing the haemorrhoidal prolapse 2 from the anus 8, while reducing its size inside the rectum 5 and additionally correctly repositioning the rectal padding (padding) above the pain threshold line.

The main circular stitching 14 thus acts as a reference point, pulling the haemorrhoidal prolapse 2 towards said reference point, and then joining with the circular stitching 1, 4, 11, so as to simultaneously create a constraint of the haemorrhoidal prolapse 2 and reduce the size of the haemorrhoidal prolapse 2 inside the rectum 5.

The method of the invention is applicable to all types and entities of operations for haemorrhoidal prolapse, and can be summarily described as comprising the formation of a plurality of circular stitches that join the haemorrhoidal prolapse and the associated rectal artery, preferably by means of a single suture and the realisation of at least one main circular stitch formed at a portion of the wall of the rectal tract not relevant to the rectal physiology.

The following description is directed to a device for use in surgery on rectal haemorrhoidal prolapse, preferably but not exclusively for use in the above-described procedure.

The device, indicated with 16, comprises a hollow separator 17, said hollow separator 17 showing a cylindrical central portion 17a, said central portion 17a providing internally a cavity 17a which is the intervening area of the device. The central portion 17a is connected to a closed front portion 17c, which front portion 17c preferably has a conical shape so that it can be inserted inside the anus of the patient, while minimizing the traumatic experience for the patient. The separator 17 also comprises a truncated-cone-shaped rear portion 17d, said truncated-cone-shaped rear portion 17d being laterally larger so as to define an interior of the separator 17 with maximum anal penetration. The rear portion 17d is also hollow in order to provide access to the cavity 17b by an external operator during surgery at the rear end 17e with respect to the direction of penetration of the separator inside the anus.

The device 16 also comprises a first half-shell 18, said first half-shell 18 being solidly constrained to the rear portion 17c of the separator 17 so as to form a handle portion of the device 16. The first half-shell 18 is preferably connected by means of joining portions 19, 20 to a second half-shell 21, said second half-shell 21 completing the handle forming the device 16. In this configuration, the stem defines, in the portion comprised between the two half-shells 18, 21, a first seat 22, said first seat 22 being intended to house the lighting means 23.

The means 23 for illumination are preferably made of optical fibers 24. The optical fiber 24 is inserted, for example at the free end of the shank, pushing inside the first seat 22 until it reaches the working position, in which the lighting means 23 emit light that can reach the inside of the separator 17 in order to light the working area (back lighting).

The separator 17 preferably displays in its lateral part a window 29, said window 29 defining the operating area and, when the device 16 is inserted, providing communication between the cavity 17b and, therefore, the means for working inside the cavity 17b and the wall of the rectum. The window 29 allows easy access to the haemorrhoidal prolapse present on the rectal wall.

The window 29 displays at least a first portion 29a, said first portion 29a being between the central portion 17a and the front portion 17 c. In the preferred embodiment shown in fig. 2 and 3, the first portion 29a of the window 29 extends generally in a direction transverse to the longitudinal axis Z along which the separator 17 develops generally. In the embodiment shown, the first portion 29a of the window 29 is rectangular.

Preferably, the front portion 17c of the divaricator 17 exhibits, in proximity to the first portion 29a of the window 29, a bevel 30, said bevel 30 serving to further assist the penetration of the divaricator inside the anus, while the bevel 30 receives the haemorrhoidal prolapse in the window 29.

The window 29 advantageously has a variable extension, preferably extending in a direction parallel to the longitudinal axis Z of the separator 17. This extensibility is achieved by means 31 of opening and closing the window 29, said means 31 being better described below.

The window 29 advantageously displays a second portion 29b, said second portion 29b being preferably adjacent to the first portion 29 a. In the preferred embodiment, the first portion 29a and the second portion 29b are in communication and thus constitute a window 29. In addition, the second portion 29b of the window 29 develops along the longitudinal axis Z of the separator 17, and preferably extends from the first portion 29a to the rear end 17e of the separator 17. The second portion 29b may have any transverse dimension, preferably less than or equal to the transverse dimension of the first portion 29 a.

The mechanism 31 for opening and closing the window is preferably realized with a moving wall 32. The mobile wall 32 is slidably housed, for example by means of a sliding guide 32a, in the second portion 29b of the window 29 and can assume a plurality of operating positions between a closed position, in which the mobile wall 32 entirely obstructs the second portion 29b of the window 29, while allowing access only to the first portion 29a, and an open position, in which the mobile wall 32 completely uncovers the second portion 29b of the window 29, so that the window 29 is entirely open and accessible from the outside. The moving wall 32 is moved between the closed position and the open position by a sliding movement in the direction of the rear end 17e of the separator 17. The increase of the extension of the window in the longitudinal direction as described above is advantageous in the pathology of haemorrhoids, in particular when the ligation operation is performed by suturing on the rectal artery.

In the preferred embodiment shown in the figures, the mobile wall 32 is associated only with the second portion 29b of the window 29, while the first portion 29a is accessible from the outside even when the mobile wall 32 is in the closed position.

The movable wall 32 may additionally show means for clamping so that the operator has a convenient clamp thereon. However, in the preferred and illustrated embodiment, the mobile wall 32 is shaped in the opposite shape to the second portion 29b of the window 29, the mobile wall 32 engaging with said second portion 29b so that, in the closed position, there is no projection of the progress of the mobile wall 32 with respect to the vertical surface of the separator 17.

The device 16 also comprises several sensors, not shown in the drawings, for detecting the pulsation of a vein or an artery, in particular for detecting the vicinity of a rectal artery. The sensor is preferably an ultrasound probe and may advantageously be mounted on the moving wall 32, preferably movable, so as to continuously monitor the vicinity of the rectal artery even during the sliding movement of the moving wall 32.

For the purpose of housing the sensor, the mobile wall 32 shows a dedicated housing 33, said housing 33 facing the outside of the mobile wall 32, and therefore the separator 17, through an external terminal opening 33a provided on the mobile wall 32. An external terminal opening 33a is placed in the casing 33 in communication with the outside of the separator 17, facilitating the detection of the rectal artery by the sensors, raising them to the wall of the rectum and placing them in direct contact with the haemorrhoidal prolapse, so that they can detect the proximity of the rectum by recording the relative blood flow. The housing 33 preferably also communicates with the cavity 17b of the separator 17 so that the sensor can be added to the interior of the housing 33 through the rear end 17e of the separator 17.

Means for guiding 34 are housed inside the cavity 17b, said means for guiding 34 being fixed to the separator 17 and destined to guide the means for surgery during use, i.e. during the operative phase. In more detail, the means for guiding 34 comprise an apertured support 35, said support 35 being preferably arranged in proximity to the first portion 29a of the window 29. In addition, the apertured support 35 is fixed in a non-central position adjacent the first portion 29a of the window 29. In addition, the apertured support 35 is fixed in a non-central position with respect to the longitudinal axis Z of the separator 17, in particular towards the window 29. This is useful for artery ligation procedures in which the curved needle gripped by the needle holder describes a circular trajectory so that the needle partially emerging from the separator 17 through the window 29 connects the relevant haemorrhoidal artery previously detected by the ultrasound probe. The circular trace is obtained by rotating the needle holder, while its front end is housed inside the holed support 35.

Externally, the separator 17 displays, at least on its central portion 17a, one or more easily visible calibration marks 36, said calibration marks 36 being, for example, a plurality of reliefs (reliefs), so as to provide a visual indication in real time of the depth of penetration of the separator 17 into the anus.

The present invention provides some important advantages.

Primarily, the method rapidly reduces hemorrhoidal prolapse while avoiding painful surgery.

In addition, the method requires less anesthesia than conventional treatments.

Among the advantages of this method, the first and most important is the best results with haemorrhoidal physiology, while at the same time protecting the vascular padding, which is important for the problem of continence.

Another advantage is provided in fact by the method, which eliminates the haemorrhoidal prolapse, since it is anchored to the main circular stitching, enabling the anal padding to be repositioned above the pain threshold line.

With respect to the above-mentioned devices, an important advantage is provided by the presence of a movable wall that can be damaged, which helps to modify the area of the operation, preferably in the case of an arterial ligation operation, even without having to partially extract the separator, which is a particularly laborious task for the surgeon.

In addition, the fixation of the sensor on the mobile wall enables a continuous check in the vicinity of the rectal artery of interest, without having to move the device if this is not strictly necessary.

Finally, the particular geometry of the mobile wall does not comprise any protruding elements, which could cause discomfort or pain to the patient; in fact, the regular shape and the anatomical shape of the wall meet the requirements for low-grade patient trauma.

Claims (10)

1. A device for surgical operations on rectal or haemorrhoidal prolapse, comprising a hollow separator (17), said separator (17) having a development direction of travel along a longitudinal axis (Z) and being insertable into the anus, the separator (17) displaying a window (29), said window (29) defining an operative area and enabling communication between an internal cavity (17b) of the separator (17) and a portion of the rectal or haemorrhoidal prolapse, wherein the separator (17) comprises means (31) for opening and closing the window (29) for assisting in the change of the operative area, said means (31) for opening and closing the window (29) comprising a mobile wall (32), characterised in that the mobile wall (32) is movable from a closed position to an open position by a sliding movement of said mobile wall (32) in the direction of a rear end (17e) of the separator (17).

2. The apparatus of claim 1, wherein the window (29) comprises: a first portion (29a) and a second portion (29b), the first portion (29a) extending in a direction transverse to said longitudinal axis (Z), the second portion (29b) extending parallel to the longitudinal axis (Z); said mobile wall (32) acts on the second portion (29b) of the window (29) so as to define the opening or closing of the window (29).

3. The device of claim 2, wherein the first portion (29a) of the window (29) is rectangular.

4. A device as claimed in claim 2, wherein said first and second portions (29a, 29b) are in communication and constitute one of said windows (29).

5. The device according to claim 4, wherein the second portion (29b) of the window (29) extends from the first portion (29a) of the window (29) all the way to a rear end (17e) of the separator (17), the rear end (17e) being defined by the direction of insertion of the separator (17) into the anus.

6. A device as claimed in claim 2, wherein the mobile wall (32) is slidably housed in the second portion (29b) of the window (29) and can assume a plurality of operating positions between a closed position, in which the mobile wall (32) entirely obstructs the second portion (29b) of the window (29) while allowing access only to the first portion (29a) of the window (29), and an open position, in which the mobile wall (32) completely uncovers the second portion (29b) of the window (29), so that the window (29) is entirely open and accessible from the outside.

7. Device according to claim 6, wherein the mobile wall (32) is associated only with the second portion (29b) of the window (29), while the first portion (29a) of the window (29) is accessible from the outside even when the mobile wall (32) is in the closed position.

8. The device according to claim 1, wherein the mobile wall (32) comprises a housing (33), said housing (33) being intended to be removably fitted with a sensor for detecting the proximity of the haemorrhoidal artery.

9. The device according to claim 8, wherein the mobile wall (32) comprises an external terminal opening (33a) for bringing the sensor in close proximity to the haemorrhoidal artery.

10. The device according to claim 8, wherein the housing (33) in the mobile wall (32) communicates with the inner cavity (17b) of the separator (17) for facilitating the insertion and fixing of the sensor on the mobile wall (32) while operating directly from the inner cavity (17 b).