HK1161534B - A device for surgical operations on a prolapse - Google Patents

Description

Device for surgical operation on prolapse

Technical Field

The present invention relates to a device for surgical intervention in prolapse.

Background

The present invention relates to the field of surgical operations related to pathologies such as anorectal, in particular for the treatment and/or reduction of prolapse.

The invention is particularly suitable for surgery on rectal mucosal prolapse, intussusception or intussusception, or for surgery on whole rectal prolapse or anal fissure, perianal fistula, perianal abscess, anal tumour or lower rectal tumour.

The field of application of the invention relates in particular to the treatment of hemorrhoids, which is one of the most common and well-known diseases, but the field of application of the invention is not limited thereto.

As is known, the onset of hemorrhoids starts with pathological changes in the cavernous body of the anal canal, which are formed by the vascular lacuna, arteriovenous shunts and the saccular venous structures that make up the internal haemorrhoidal plexus. In more detail, the internal haemorrhoidal plexus is a blood cavity of a diameter of a few millimetres, defined by a venous or capillary type endothelium within connective tissue, covered by the rectal mucosa. These structures are supported to the internal sphincter muscle, known as the Treitz ligament or Parks ligament, by anchoring fibers.

The corpus cavernosum receives a portion of the arterial blood flow from the terminal branch of the superior rectal artery, and this characteristic has led to recent developments in therapy.

Advances in surgical techniques have focused on minimally invasive interventions.

The main surgical technique used in the past and still in use today is based on tissue removal, i.e. the surgical removal of the part affected by the lesion, which therefore cannot be classified into any type defined as minimally invasive.

The first technique involves identifying and isolating mucosal tissue affected by prolapse, after which the tissue is removed using forceps.

Once the prolapse has been removed, the technique may include closing the wound with a sutured lip, or alternatively, leaving the resection area untreated.

This procedure requires a great deal of surgical experience for the surgeon and also causes considerable discomfort to the patient after the operation, associated with the formation of scar tissue around the wound, thereby causing considerable pain.

Another surgical technique involves removing a portion of the rectal mucosa upstream of the area involved in the prolapse by mechanical suturing.

In more detail, the method consists in acting on the rectal wall by means of a ring-shaped or circular structure, which is similar in appearance to a pouch of tobacco. This is done by suturing a number of times with a thread until a portion of circumferentially extending mucous membrane located upstream of the prolapse is covered, thereby forming a substantially annular protrusion protruding into the ampulla of the rectum.

The annular protrusion thus formed is then cut off with a mechanical sewing machine which, at the same time, sews the residual side-by-side flaps of the adhesive membrane wall with metal staples.

In this case, the method outlined above also requires considerable experience from the surgeon and can lead to considerable discomfort for the patient during the post-operative period, often with complications.

Another surgical intervention technique is based on the surgical closure of the end portion of the superior rectal artery that causes the prolapse, and the subsequent closure thereof, resulting in the interruption of the blood flow and the reduction of the mucosal prolapse.

This technique is performed by using a device comprising a substantially cylindrical body with a spreader action, with a handle and an opening or window in a lateral position for intercepting and observing the prolapsed portion.

The device also comprises a movable wall defining, with the cylinder, a through-window defining an access area and capable of allowing access to the prolapsed portion from the lumen of the cylinder.

More precisely, the movable wall is slidably connected to the cylinder and is movable with respect to the cylinder so as to widen or narrow the insertion zone defined by the wall. In this way, surgery can be performed in a larger area without having to move the entire device.

Near the window, the cylinder comprises a seat for housing a probe (in particular an ultrasound probe) which can detect the vicinity of the blood vessel in order to correctly guide the suturing operation even if this area is poorly accessible or visible. The device also includes means for illuminating, coupled to the handle, for illuminating the area associated with the procedure and, if necessary, for diffusing the light in the cylinder.

The known types of devices are obviously not convenient for the operator to use.

When inserting the device into the anus, the movable wall must not move relative to the cylinder and must be fully inserted so that the window is in the minimum extension configuration.

However, during insertion, the distributed load exerted by the anal canal on the device tends to move the movable wall and move it away from the operative position.

Thus, during insertion of the device, the operator must take care to keep the movable wall in place. In other words, the operator must exert a counter pressure on the movable wall, together with a force exerted on the rest of the device, to keep the movable wall in position.

The use of devices of known type is therefore particularly inconvenient for the operator.

When the inserted device must be rotated, the force acting on it causes it to twist. During rotation of the device, the load exerted by the anal canal creates a torque couple on the device, thereby moving the device itself. This deformation may determine the detachment of the movable wall from the cylindrical body. In this case, the device must be extracted and reinserted when the movable wall is reconnected to the cylinder.

In this case too, therefore, the operator must be particularly alerted so that rotation of the device does not result in the movable wall unintentionally separating from the cylinder.

Disclosure of Invention

In view of the above, it is therefore the technical object of the present invention to provide a device for surgical operations on prolapse which does not present the drawbacks mentioned above.

In particular, it is an object of the present invention to provide a device for surgical operations on prolapse which is comfortable and easy to use.

Further, it is an object of the present invention to provide a device for surgical operations on prolapse which allows a quick intervention with as little trauma as possible.

The technical aim and objects described are achieved in the present invention by a device for surgical intervention in prolapse, comprising the technical features defined in one or more of the appended claims.

Drawings

Further characteristics and advantages of the invention will better emerge from the description that follows, a preferred but not exclusive embodiment of the device for surgical intervention on prolapse, illustrated in the accompanying drawings, by way of non-limiting example, in which:

fig. 1 is a side view of a device for performing surgery on a prolapse, in accordance with the present invention;

FIG. 2 is a side view of the device of FIG. 1 in a different operating configuration;

FIGS. 3a and 3b illustrate perspective views of various unique portions of the device of FIG. 1; and

fig. 4 is a cross-sectional view taken along line IV-IV of fig. 1.

Detailed Description

With reference to the figures, the numeral 1 denotes in its entirety a device for performing surgery on a prolapse.

The device 1 comprises a distractor body 2 which is hollow and extends along a longitudinal axis a, and has a central portion 2a which is substantially cylindrical and defines a cavity 3 therein, which is the operating area.

The central portion 2a interfaces with a peaked closed anterior portion 2b, which is also preferably tapered to facilitate insertion of the anterior portion 2b into the anus of the patient, thereby minimizing trauma to the patient.

The distractor body 2 also comprises a frustoconical rear portion 2c having a large transverse dimension, in particular diverging towards the outside, for maximum insertion of the distractor body 2 into the anus.

This rear portion 2c is also hollow so as to allow the external operator to access the cavity 3 during the operation, the rear end 2c being accessible along the insertion direction of the distractor body 2 into the anus.

The device 1 further comprises a handle 4 rigidly connected to the distractor body 2. A receiving channel 5 is provided in the handle 4 (fig. 1 and 3b), in which a lighting device (not shown in the figures) is provided.

The illumination device is preferably made of optical illumination fibers.

The optical fibre is inserted, for example, at the free end 4a of the handle 4 and then pushed until it reaches the working position, in which it emits light that can reach inside the spreader body 2 to illuminate the working area (backlighting).

The first half-shell 6a is rigidly fixed to the rear portion 2c of the distractor body 2 and constitutes at least partially the handle 4 of the device 1. In the embodiment described, the receiving channel 5 for the lighting device is formed entirely in the first half-shell 6 a.

The first half-shell 6a is preferably connected to the second half-shell 6b by means of male and female connection means, thus completing the formation of the handle 4 of the device 1.

The distractor body 2 has a through window 7 which defines the operating area and, when the device 1 is completely inserted, enables communication between the cavity 3, the operating means located in the cavity 3, the rectal wall. Thus, the window 7 allows easy access to the prolapsed portion on the rectal wall.

In the depicted embodiment, the window 7 is disposed opposite the handle 4 relative to the distractor body 2.

The window 7 advantageously has a variable extension, preferably in a direction parallel to the longitudinal axis a of the distractor body 2. This is achieved by means of a movable wall 8 connected to the distractor body 2, which defines, together with the distractor body 2, a through-window 7.

The movable wall 8 is slidably connected to the distractor body 2 in order to open and/or close the window 7 to vary its extension. In particular, the window 7 is at least configurable between a minimum reach configuration and a maximum reach configuration. The window 7 may also be configured in a plurality of intermediate configurations corresponding to respective extensions between a minimum extension and a maximum extension.

The window 7 has at least a first portion 7a, which is formed between the central portion 2a and the front portion 2 b. The first portion 7a of the window 7 extends mainly in a direction transverse to the longitudinal axis a along which the distractor body 2 mainly extends. In addition, in the illustrated embodiment, the first portion 7a of the window is rectangular.

The window 7 advantageously also has a second portion 7b, preferably adjacent to the first portion 7a (fig. 2). In the illustrated embodiment, the first portion 7a and the second portion 7b are in communication, thus forming a single window 7. In addition, the second portion 7b of the window 7 extends along the longitudinal axis a of the distractor body 2, and preferably extends from the first portion 7a to the rear end 2d of the distractor body 2. The second portion 7b may have any transverse dimension, preferably greater than or equal to the transverse dimension of the first portion 7 a.

The movable wall 8 is slidably housed in the second portion 7b of the window 7 and can assume a plurality of operating positions between a closed position, in which the movable wall 8 completely covers the second portion 7b of the window 7 and only the first portion 7a is accessible, and an open position, in which the movable wall 8 completely uncovers the second portion 7b of the window, so that the window is completely open and accessible from the outside.

In other words, when the movable wall is in the closed position, the window is in the minimum extension configuration, and when the movable wall 8 is in the open position, the window 7 is in the maximum extension configuration, the movable wall 8 being detached from the distractor body 2.

The movement of the movable wall 8 between the closed position and the open position is in particular carried out by it sliding in a direction towards the rear end 2d of the distractor body 2.

The increase in the longitudinal extension of the window 7, achieved as described above, is advantageous, in particular in the case of a ligature operation of the rectal artery in haemorrhoidal pathologies.

The movable wall 8 of the device 1 of the invention also comprises gripping elements 9, which extend on opposite sides of the spreader body 2, to grip and move the movable wall 8. The gripping element 9 comprises a knurled flat portion 9a to further improve the grip.

In a preferred embodiment and as shown in the figures, the movable wall 8 is connected only to the second portion 7b of the window 7, while the first portion 7a is accessible from the outside even when the movable wall 8 is in the closed position.

In the preferred and illustrated embodiment, the movable wall 8 is substantially complementary in shape to the second portion 7b of the window 7 with which it is intended to engage, so that in the closed position the movable wall 8 does not protrude with respect to the vertical plane of the distractor body 2.

The device 1 further comprises blocking means 10, which blocking means 10 act between the movable wall 8 and the distractor body 2 to keep the wall 7 in the aforementioned minimum-extension configuration when the distractor body 2 is inserted into the anal canal of the patient. In other words, the blocking means 10 act on the movable wall 8 to keep the wall 8 in the closed position during the insertion phase.

The obstruction means 10 comprise at least one appendage 11 elastically connected to the movable wall 8. By means of a snap fit, this appendix 11 can be inserted into and extracted from a corresponding seat 12 (fig. 3b) formed in the distractor body 2.

In more detail, the device 1 comprises two guides 13 extending parallel to the longitudinal axis a and formed on the distractor body 2. The device 1 further comprises two sliders 14 rigidly connected to opposite sides of the movable wall 8 and slidably inserted in the guides 13.

In the preferred embodiment, the blocking device 10 comprises two appendages 11, each elastically connected to a slider 14 and connectable to two respective seats 12 formed in the distractor body 2 (fig. 3 a).

In more detail, each slider 14 includes a fixed portion 14a formed integrally with the movable body 8 and a projecting portion 14b extending from the fixed portion 14a of the slider 14 toward the front end 2e of the distractor body 2. Therefore, the projecting portion 14b can elastically vibrate with respect to the fixed portion 14 a.

In addition, the tooth 14c is formed on only one of the two sliders, the tooth 14c abutting against the corresponding sliding guide to compensate for any tolerance of fit between the slider 14 and the guide 13.

The appendix 11 is advantageously provided on the projecting portion 14b of each slider 14. In more detail, the appendix 11 is arranged at the front end 2a of the movable wall 8.

Each seat 12 is aligned with a respective guide and is separated from each other by a projection 15.

In use, the movable wall 8 is connected to the distractor body 2 so as to bring each slide 14 into the corresponding seat 12. In this way, each slider 14 and the associated appendix 11 move along the guides 13 until the appendix reaches the projection 15. Under further pressure, each appendix 11 passes over the projection 15, so that the projecting portion 14b of each slider 14 elastically bends and therefore the appendix 11 reaches the corresponding seat 12.

When the device 1 is inserted into the anal canal of a patient, the force resulting from the distributed load generated by the anal canal tends to push the movable wall 8. However, the appendages 11 are in contact abutment with the respective projections 15 to prevent unwanted movement of the movable wall 8 relative to the distractor body 2.

If the operator applies a higher intensity force to the movable wall 8, the appendix 11 re-bends the projecting portion 14b and withdraws from the respective seat 12 to move the movable wall 8 with respect to the spreader body. In this way, the window 7 can assume a desired configuration.

Each guide 13 comprises a respective wall 16 defining a respective flat surface 16a, on which respective sliders 14 rest. Each wall 16 is perpendicular to a central symmetry plane P passing through the longitudinal axis a (fig. 4) of the distractor body 2. This feature advantageously gives the device, in particular the movable wall 8, greater stability.

In view of the elasticity of the tissue of the anal wall, it is known that when a foreign body is inserted into the anal cavity, the patient's contraction will push the foreign body out of the cavity.

As far as the entire device 1 is concerned, and in particular as far as the spreader body 2 is concerned, the spreader body 2 remains inside the anal cavity, since the surgeon also intervenes.

The movable wall 8 obtains two different states.

In the condition in which the window 7 is in the configuration of minimum extension, that is to say in which the movable wall 8 is in the closed position, the obstruction means 10 keep the movable wall 8 in a stable position.

In the condition in which the window 7 is in the desired configuration, that is to say in which the movable wall 8 is between the closed position and the open position, the friction generated between each slider 14 and each respective flat bearing surface 16a of the guide 13 reassures the stability of the movable wall 8 in the reached position.

The presence of the flat bearing surface 16a of the guide 13 allows the distributed load exerted by the anal musculature (which may be considered as a concentrated force) to be divided into two corresponding restraining counter-forces, each of which is half the strength of the force applied to the musculature.

The consequent friction between the respective bearing surface 16a of the guide 13 and the slider 14 (which is equal to the counterforce of restraint of the bearing surface 16a for a typical coefficient of friction of the chosen material) is maximum, since there is no counterforce of restraint other than the force that counters the resultant force exerted by the muscle tissue.

Furthermore, each guide 13 comprises a further wall 17, which further wall 17 is facing and parallel to the wall 16 defining the support surface 16 a. Each slider 14 is completely inserted between and moves between a wall 16 and another wall 17 of the guide 13.

Each guide 13 also includes a respective rib 18, the rib 18 extending generally from the rear end 2d of the distractor body 2 and being parallel to the wall 16 and the further wall 17 of the respective guide 13.

Each rib 18 projects from the distractor body 2 toward the cavity 3, and the projecting amount gradually decreases from the rear end 2d toward the front end of the distractor body 2.

Each rib 18 is in contact with the corresponding slider 14 so that the movable wall 8 does not detach and stick and snag during the movement of the movable wall 8 with respect to the spreader body 2.

The device 1 further comprises an anti-twisting device 19 arranged between the distractor body 2 and the movable wall 8 to limit or prevent twisting deformations of the device 1.

An anti-twist device 19 is provided at the rear end 2d of the distractor body 2 and is active when the wall 7 is in the minimum extension configuration.

The anti-twist means 19 comprise at least one projection 20 associated with the movable wall 8, which projection 20 is insertable into a corresponding opening 21 formed in the distractor body 2.

In detail, the anti-twisting device 19 comprises a pair of tabs connected to the distractor body 2 at the rear end 2d of the distractor body 2. The tabs 22 are arranged symmetrically with respect to the central symmetry plane P. The tabs 22 are coplanar with one another.

In addition, the anti-twisting means 19 comprise a respective pair of flanges 23, which are symmetrically arranged with respect to the central symmetry plane P and are coplanar with each other. A flange 23 is formed at the rear end of the movable wall 8.

Two projections 20 are formed on the flange 23 of the movable wall 8 and can be inserted into corresponding openings 21 formed in the tabs 22 of the distractor body 2. The shape of the opening 21 is complementary to the shape of the protrusion 20.

In particular, when the movable wall 8 is in the closed position and the window is in the configuration of minimum extension, the tab 22 faces the flange 23 and is in contact with the flange 23 and the projection 20 is inserted into the opening 21.

In this way, the torsional action determined by the torque load generated by rotation of the device within the anus is absorbed by the engagement between the protrusion 20 and the opening 21, the torque momentum being unloaded between the protrusion 20 and the opening 21.

Thus, when the device 1 is inserted into the anal canal and rotated, it neither twists nor bends. Thus, the device 1 is more stable and cannot be accidentally separated between the distractor body 2 and the movable wall 8.

A sensor (not shown) may also be connected to the device 1, which detects the pulsation of a vein or artery, in particular the proximity of the sensor to the rectal artery. The sensor means are preferably constituted by an ultrasound probe and can be advantageously housed on the movable wall 8, preferably removable, in order to monitor, for example, continuously the vicinity of the rectal artery, even during the sliding of the movable wall 8.

In order to encapsulate the sensor, the movable wall 8 has a dedicated housing 24, the housing 24 facing the outside of the movable wall 8 and thus also of the distractor body 2, through an outer end opening formed in the movable wall 8 (fig. 3 a).

The outer end opening 25 communicates the housing 24 with the exterior of the distractor body 2, and the outer end opening 25 facilitates the detection of the rectal artery by a sensor by facing the sensor toward the rectal wall and by directly contacting the sensor with tissue so that the sensor can detect the vicinity of the artery by detection of blood flow.

The receptacle 24 preferably also communicates with the cavity 3 of the distractor body 2, so that the sensor can be inserted into the receptacle 24 through the rear end 2d of the distractor body 2.

The invention achieves the set objects and provides significant advantages.

The blocking device of the device for the surgical operation of prolapse of the present invention prevents the sliding of the movable wall during the phase of insertion of the device into the anal canal.

In this way, it is no longer necessary for the operator to perform a particular manoeuvre to hold the movable wall in position at this stage.

Furthermore, any final rotation phase of the device in the anal canal is simplified, since the anti-twist means guarantees sufficient stability of the device and prevents the movable wall from backing out of its seat.

Claims (17)

1. A device for performing a surgical procedure on a prolapse, the device comprising:

a hollow distractor body (2) which extends substantially in the direction of a longitudinal axis (A) and which is insertable into a body orifice, the distractor body (2) having a through-window (7) which defines an access area and allows communication between an inner cavity (3) of the distractor body (2) and a part of the prolapse,

a movable wall (8) which defines, jointly with the distractor body (2), the through window (7) and is slidably associated with the distractor body (2) to open and/or close the through window (7) between a minimum extension configuration and a maximum extension configuration of the through window (7);

a blocking device (10) acting between the movable wall (8) and the distractor body (2) to stably maintain the through window (7) in the minimum extension configuration during the insertion of the distractor body (2);

the method is characterized in that: the blocking device (10) comprises at least one appendage (11) which is elastically connected to the movable wall (8) and which can be inserted and extracted by snap-fitting into a corresponding seat (12) formed in the distractor body (2).

2. The apparatus of claim 1, wherein: the device comprises at least one guide (13) formed in the distractor body (2) and at least one slider (14) connected to the movable wall (8) and slidable in the guide (13); the attachment (11) is connected to the slider (14).

3. The apparatus of claim 2, wherein: the device comprises two guide parts (13) formed in the distractor body (2) and two sliders (14) respectively connected with two opposite sides of the movable wall (8); the device also comprises two appendages (11), each attached to a respective slide (14), and two seats (12), each of which can be occupied by a respective appendage (11).

4. The apparatus of claim 3, wherein: each slider (14) comprises a fixed portion (14 a) rigidly connected to the movable wall (8) and a projecting portion (14 b) projecting from the fixed portion (14 a) towards the front end (2 e) of the distractor body (2); the attachment (11) is provided on the projecting portion (14 b).

5. The apparatus of claim 3, wherein: each seat (12) is aligned with a respective guide (13) and separated from the respective guide by a projection (15).

6. The apparatus of claim 4, wherein: each guide (13) comprises at least one wall (16) which is perpendicular to the central symmetry plane (P) and which defines a flat surface (16 a) on which the slider (14) is placed.

7. The apparatus of claim 6, wherein: each guide (13) further comprises a further wall (17) facing and parallel to said wall (16); each slider (14) is interposed between the wall (16) and the other wall (17).

8. The apparatus of claim 7, wherein: each guide (13) also comprises a respective rib (18) extending from the rear end (2d) of the distractor body (2) parallel to the wall (16) and the other wall (17), which rib is in contact with the slider (14) to keep the movable wall (8) aligned with the distractor body (2).

9. The apparatus of claim 3, wherein: one or both of the sliders (14) has a tooth (14 c) for abutting against the corresponding guide (13) to compensate for any tolerance of fit between the slider (14) and the guide (13).

10. The apparatus of claim 1, wherein: the device also comprises an anti-twisting device (19) operatively arranged between the distractor body (2) and the movable wall (8) to limit the torsional deformation of said device; the anti-twisting device (19) is arranged at the rear end (2d) of the distractor body (2) and is active when the through-window (7) is in the minimum extension configuration.

11. The apparatus of claim 10, wherein: the anti-twisting device (19) comprises at least one projection (20) connected to the movable wall (8) and insertable into a corresponding opening (21) formed on the distractor body (2).

12. The apparatus of claim 11, wherein: the anti-twisting device (19) comprises two projections (20) which can be inserted into corresponding openings (21) arranged symmetrically with respect to a plane of symmetry (P) of the device.

13. The apparatus of claim 12, wherein: the distractor body (2) comprises two tabs (22) arranged in proximity of said rear end (2d) and symmetrically with respect to a plane of symmetry (P), said openings (21) being formed in correspondence on said tabs.

14. The apparatus of claim 12, wherein: the movable wall (8) comprises two flanges (23) arranged symmetrically with respect to the central symmetry plane (P), on which the projections (20) are arranged.

15. The apparatus of claim 1, wherein: the movable wall (8) comprises gripping elements (9) extending on the opposite side with respect to the distractor body (2) for gripping the movable wall (8) and moving it with respect to the distractor body (2).

16. The apparatus of claim 1, wherein: the device also comprises a handle (4) fixed to the distractor body (2), the handle (4) defining internally a seat (5) for housing the lighting means.

17. The apparatus of claim 1, wherein: the movable wall (8) comprises a housing (24) for removably housing a sensor for detecting the vicinity of the haemorrhoidal artery.