ES2538428B1 - Endoscopic device for perineal approach to rectal cancer - Google Patents

Abstract

Endoscopic device for the perineal approach to rectal cancer # The invention describes a new device (1) specially designed to carry out a new surgical approach for amputation of the rectum in cases of cancer comprising a circular endoscopic tube (2) and a cap (3) attachable to a proximal end of the endoscopic tube (2), where the diameter of the tube (2) is larger than the diameter of a patient's rectum and where an inner portion (3a) of the cap (3) is rotating in relation to an outer portion (3b) of said lid (3) that is attachable to the endoscopic tube (2), the inner portion (3a) of the lid (3) comprising a central port (4) provided with a joint (5) ) spherical to which a tube (6) is attached to accommodate an optical viewing means and a plurality of peripheral working ports (7) for the introduction of laparoscopic instruments.

Description

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DESCRIPTION

Endoscopic device for perineal approach to rectal cancer

5 OBJECT OF THE INVENTION

The present invention belongs to the field of surgery, and more specifically to the perineal approach of rectum resection surgery.

The object of the present invention is a new device specially designed to carry out a new surgical approach for amputation of the rectum in cases of cancer.

BACKGROUND OF THE INVENTION

15 Colorectal cancer is a prevalent disease with important socioeconomic connotations. In Western countries it ranks second in incidence after lung cancer in men and breast cancer in women, accounting for approximately 10-15% of all cancers.

20 The better knowledge of the nature of the disease, improvements in surgical technique, and the development of cancer treatments have allowed important advances in the treatment of this process. Especially complex is the surgical approach for the removal of the rectum due to its anatomical location within the bony frame of the pelvis. Such procedures have a non-negligible morbidity and mortality, as well as sequelae

25 (colostomy, impaired defecation function, sexual and urinary dysfunction) that lead to a reduction in the quality of life.

Abdominoperineal amputation (AAP) of the rectum was initially described by Ernest Miles in 1908. Oncological surgery of the lower rectum had to resect rectum, sphincters, muscles

30 elevators of the anus, ischirectal fat, pelvic peritoneum and adjacent nodes of the mesorectum. This operation should be limited to tumors that infiltrate the sphincteric apparatus. At present this intervention is carried out in 2 phases or times according to the technique called Extra-Elevating Abdominoperineal Excision (ELAPE).

35 The first phase of the ELAPE technique is performed abdominally with the patient placed in the supine position (lying on his back) and consists of carrying out the

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dissection and section of the intraperitoneal rectum (inside the abdomen) with high ligation of the vascular pedicle, subsequently performing a colostomy. This operation can be performed either by laparoscopic route or by open surgery practicing a high ligation of the vascular pedicle.

The second phase of the ELAPE technique is carried out perineally with the patient placed in the prone position (lying face down) and involves dissecting the rectum starting from the perianal skin. For this, a circular incision of the perianal skin is made that allows access to the perirectal tissue by performing a cylindrical excision including the following elements in block: rectum, mesorectal fat and lifting muscles. Subsequently, the entire piece is removed by the perineum.

Fig. 1 schematically shows the areas that are accessed by abdominal and perineal route. Specifically, dissection of the areas marked "abdominal" and "retroperineal" is carried out in the first phase by abdominal route, while dissection of the area marked "pelvic" is carried out in the second phase via perineal Fig. 7 shows another scheme where the resection lines that are carried out abdominally and perineally are represented.

Currently, the second part of the ELAPE technique is carried out without the help of specific surgical instruments. Basically, a circumferential incision is made around the anus and the patient's tissues are desiccated as it moves inwards until it meets the resection line that was previously made in the first part by abdominal route. Then, the entire piece is removed perineally. However, with this procedure as progress is made towards the interior of the kind of "well" that constitutes the surgical field, visibility and accessibility are getting worse until it constitutes an important limitation. In the first place, there is a significant lack of luminosity as it is a reduced and increasingly deep field. In addition, the assistance of an assistant located behind the surgeon's back is necessary to separate the incision. On the other hand, it is not feasible to perform the second phase of the ELAPE technique with the patient in supine position due to limitations related to the previous ones, such as the inconvenience of the surgeon being forced to operate sitting between the patient's legs, or the appearance of difficulties in visualizing the anterior face of the rectum adjacent to the prostate or vagina, which requires the surgeon to descend further above the level of the operative field to be able to look "up." All this entails a greater risk of rectum perforation which is associated with a higher index

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of tumor recurrence.

The consequence of all these inconveniences is that, after performing the first phase of the ELAPE technique with the patient in the supine position, it is essential to change the position patient to carry out the second phase with the patient in the prone position. The change of position of the patient during a surgical operation is generally inadvisable due to the associated risks and lengthens the duration of the operation. In addition, although the change in the patient's position partially resolves some of the aforementioned problems, problems related to lack of visibility and accessibility persist as progress is made towards deeper areas below the sacrocoxigent bone plane or above the lifting muscles.

DESCRIPTION OF THE INVENTION

The inventor of the present application has developed a new technique called Endoscopic Extra-Elevating Perineal Excision (ELPEe) that is developed with the patient at all times in the supine position. As a consequence, the ELPEe technique not only avoids the need to change the position of the patient during the operation, but also allows both abdominal and perineal phases to be performed simultaneously, thus reducing the duration of the operation.

The development of the ELPEe technique for dissection of the rectum in the perineal phase involves the use of a novel endoscopic device specially designed to provide access to the outer area of the patient's rectum. This new device provides better visibility and luminosity of the deep area of the operative field, in addition to allowing easier distal access, which leads to a decrease in the possibilities of rectal perforation that increase the recurrence rate.

There are currently some endoscopic devices to perform surgical operations from inside the patient's rectum. For example, the device known as TEO (Transanal Endoscopic Operations) manufactured by the company Karl Storz can be mentioned. This device is mainly formed by a thin tube equipped with a series of ports for the introduction of laparoscopic instruments and an optical visualization medium that is equipped with a viewfinder. The TEO is designed to be introduced through the patient's anus in order to provide the surgeon with access to the inside of the rectum, for example to carry out the removal of polyps or

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rectal tumors that only affect the wall by resecting a patch of it. Fig. 2 schematically shows the position taken by a TEO device during a surgical operation.

However, this type of device is not useful for performing a technique such as ELAPE, where the resection has to be performed outside the rectum, and that involves the removal of sphincters and the creation of a colostomy. The differences between the TEO device and the device described herein will be clear from the following description.

The device for endoscopic perineal extra-elevating excision (ELPEe) of the rectum according to the present invention basically comprises a circular endoscopic tube and a cap attachable to a proximal end of the tube, the diameter of the tube being greater than the diameter of a patient's rectum to allow the surgeon access to the outside of the patient's rectum. In addition, an inner portion of the lid is rotatable relative to an outer portion of said lid that is attachable to the endoscopic tube, and the inner portion comprises a central port provided with a spherical joint to which a conduit to accommodate an optical means is attached. of visualization and a plurality of peripheral working ports for the introduction of laparoscopic instruments.

As the diameter of the tube is greater than the diameter of the patient's rectum, the external walls of the rectum can be accessed to excision from the outside. This fact, together with the use of the duct with the spherical ball joint adjustable for the optical display means, allows to greatly improve visibility during operation. In addition, the tube itself exerts a function of containment of the patient's tissues, achieving an extension of the surgical field and better accessibility to it.

Preferably, the tube has a diameter between 7 cm and 14 cm and a length between 10 cm and 17 cm. According to these measures, the peripheral ports located on the periphery of the inner portion of the lid may be located at a distance between 3 cm and 7 cm from the center of the lid. Since the rectum of the patient normally has a diameter of about 3-4 cm, the peripheral ports thus allow the laparoscopic instruments introduced through them to access the external wall thereof.

Preferably, the device of the invention further comprises the optical display means itself disposed within the conduit coupled to the ball joint. In that case, the

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optical viewing medium is formed by a telescopic tube equipped with a viewing optics and a light source. More preferably, the optical display means is connectable to an HD or 3D camera that allows the visualization of the images obtained through a monitor.

In another preferred embodiment of the invention, the device comprises means for immobilizing the inner portion in various rotational positions relative to the outer portion. These means can be implemented in different ways. For example, the inner portion and the outer portion may be provided with complementary teeth so that the rotation of one relative to the other is performed according to a finite number of positions that require the application of a certain force to pass from one to the other. . In another alternative option, a ratchet element can be implemented to block the rotation of the inner portion relative to the outer portion, for example when a button is pressed.

On the other hand, the use of electrocoagulation instruments or ultrasonic section and the like cause the generation of fumes and flue gases that need to be evacuated. In addition, in this type of operations it is usual to insufflate CO2 in order to create a space that facilitates the dissection and separation of patient tissues. Therefore, in another preferred embodiment of the invention the endoscopic tube further comprises a first auxiliary port for CO2 insufflation and a second auxiliary port for smoke extraction.

To prevent the loss of CO2 from inside the patient, in a preferred embodiment of the device of the invention a distal end of the tube is also used an adhesive ring that can be attached to the distal end of the endoscopic tube to minimize CO2 leakage. This ring can be made of one of the following materials: rubber, foam, gel, and a combination thereof.

Peripheral laparoscopic instrument input ports must also be designed to minimize CO2 leakage. To do this, they preferably have rubber sleeves fitted with valves. For example, these sleeves may be formed by a rubber or rubber cylinder provided with a pair of circular diametral flanges for coupling to the corresponding peripheral port.

In addition, to hold the device of the invention during the duration of the operation, it preferably comprises an articulated mechanism having a first end attachable to the endoscopic tube and a second end attachable to a surgical table. Thus, once the device is placed in a certain position, the articulated system joints are immobilized so that the device does not move until necessary.

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5 BRIEF DESCRIPTION OF THE FIGURES

Fig. 1 schematically shows the tissues that are accessed by abdominal and perineal route during the known ELAPE technique.

10 Fig. 2 schematically shows the position of a TEO device according to the prior art during a surgical operation.

Fig. 3 shows a perspective view of an example device according to the present invention.

15 Fig. 4 shows a front view of the device of the example device of the previous figure.

Fig. 5 shows a longitudinal section of the device example of figures 20 above.

Figs. 6a, 6b and 6c respectively show details of the connection of the optical display medium to an HD camera and of the rubber sleeves of the peripheral ports.

Fig. 7 schematically shows the resection lines that are performed abdominally and perineally according to the ELAPE and ELPEe technique.

Fig. 8 schematically shows the position of the device according to the invention during a rectum amputation operation according to the ELPEe technique described herein. 30

PREFERRED EMBODIMENT OF THE INVENTION

The device (1) of the invention is described below with the aid of the attached figures. Figs. 3-5 show perspective, front and longitudinal section 35 views of an example of device (1) according to the invention. It can be seen how the device (1) is formed by an endoscopic tube (2) of 7 cm in diameter and 14 cm in diameter.

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length at whose proximal end a cover (3) is attached. For example, the cover (3) can be coupled to the tube (2) by means of a thread, as shown in Fig. 5. In turn, the cover (3) is formed by two parts that can rotate relative to each other. : an internal portion (3a), which has a central port (4) and four peripheral ports (7), and an external portion (3b) which is the one that is threadedly coupled to the tube (2).

When in this example the portion (3b) external to the tube (2) is threaded to form a rigid joint between both pieces, the internal portion (3a) which in this example covers almost the entire interior surface of the cap (3) circular can rotate relative to the tube (2). As a consequence, the relative position of the peripheral ports (7) relative to the tube

(2) changes, while maintaining the position of the central port (4) to which the conduit (6) is coupled by means of the spherical joint (5). This allows changing the relative position of the laparoscopic instruments that are introduced through these ports (7) in relation to the patient's rectum. In addition, since said ports (7) are located at a distance of about 4cm in relation to the center of the inner portion (3a) of the lid (3), the external part of the rectum can be accessed. The diameter of the peripheral ports (7) can be between 1.5-3 cm.

The ports (7) are equipped with sleeves (13) that serve to prevent CO2 from escaping. These sleeves (13), which have been drawn in greater detail in Figs. 6b and 6c, are different from those used in the prior art which were formed by two pieces that were to be coupled to the ports (7) respectively on the inner side of the lid (3) and on the outer side of the lid (3 ). In this case, the sleeves (13) consist of a single piece that has two radial flanges that prevent them from leaving the port (7) to which they are attached. One of the ends of the sleeve (13) has a hole of 5 or 12mm to insert the laparoscopic instrument in question, while the opposite end has a small valve that prevents CO2 from escaping.

In addition, the device (1) of the invention has a first port on the periphery of the tube (2)

(8) auxiliary for the insufflation of CO2 and a second auxiliary port (9) for the extraction of fumes and gases.

As can be seen in Fig. 6a, the optical display means that is introduced into the conduit (6) is formed by a telescopic tube provided with a 0º-30º optics and a lighting medium (not shown), which may be implemented by a fiberglass light cable. In addition, as can be seen at the proximal end of the optical medium of

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There is a connection to send the images to an HD camera, and then to a processor with a screen. This is advantageous in relation to the prior art, since it prevents the surgeon from having to keep his sight at the height of the perineal incision, which is sometimes cumbersome because of the patient's position.

The device (1) of this example also comprises a gel adhesive ring (12) that is placed on the distal end of the tube (2) to seal even better before possible CO2 leaks.

Fig. 7 shows an approximate scheme of resection lines for amputation of the rectum according to the ELAPE technique. The rectum is visible, whose wall is formed at its end near the skin by the external and internal sphincters. In the area outside the sphincters, the dissection line in the ischiorectal fat has been represented with a dashed line until it reaches the insertion of the lifting muscles in the pelvis. Once these muscles are sectioned, the mesorectal fat is reached, the plane of which has been dissected abdominally in the first phase of ELAPE, and the entire piece can be removed.

The new ELPEe technique basically follows the same resection lines as the ELAPE technique, although the procedure is completely different. The new ELPEe technique begins with the making of an incision around the rectal wall, and then progresses inwards through the ischiorectal fat. When a point is reached where vision is difficult due to the position of the patient and the depth of the operative field, the device (1) of the invention is placed inside the incision (but outside the rectum), and dissection is continued around the rectal wall with better vision and brightness. The device (1) not only improves visibility and luminosity, but also serves as a support for the patient's tissues and allows for a more open surgical field. Dissection is continued inwards until the lifting muscles are sectioned and even dissecting the mesorectal fat. Finally, the point of union is reached with the simultaneous dissection performed by another surgeon by abdominal route.

Fig. 8 schematically shows the position taken by the device (1) of the invention during a surgical procedure according to the ELPEe technique. It is observed how having the device (1) a diameter larger than the diameter of the rectum, the surgeon is provided access to the outer area thereof. In Fig. 8 it can be seen how tweezers and a scalpel that are introduced through the perimeter holes (7) of the device (1) of the invention have access to the outer wall of the rectum to effect resection. It is also appreciated how the display medium housed inside the tube (6) is connected to a cable that sends the obtained images to the HD camera and subsequently to a screen where the images are displayed in real time. You can also see the auxiliary port (8) through

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5 of which CO2 insufflation is carried out and the auxiliary port (9) through which the fumes generated during the operation are extracted.

Note that the TEO device mentioned previously in this document and represented in Fig. 2 is not useful for carrying out the ELPEe procedure. Among other reasons, your

The diameter is much smaller because it is intended to pass through the anus until it enters the inside of the rectum, as shown in Fig. 2. In addition, it does not have any rotating lid portion, the positions of its ports being fixed laparoscopic instrument input.

15 The main steps to carry out this operation according to the ELPEe technique will be briefly described below:

1) The abdominal approach hardly varies in relation to ELAPE, being able to be performed by laparoscopy or open surgery. In any case, by performing the perineal approach 20 simultaneously without changing the patient's position, dissection can be terminated.

highest mesorectal.

2) The perineal approach begins with a circular incision in the perianal skin, around the rectal wall is progressed by ischiorectal fat, sectioning muscles 25 anococcigeos and dissecting the initial centimeters of the anterior aspect of the rectum.

3) After the first centimeters of dissection, when the vision is difficult due to the position of the patient and the depth of the operative field, the device is placed

(1) inside the incision and dissection is continued around the rectal wall 30 with better vision and luminosity.

4) Circumferential progress is made by sectioning the lifting muscles in their pelvic insertion and even dissecting the mesorectal fat until the simultaneous dissection of another abdominal surgeon is achieved.

35 5) Finally, the device (1) is removed and the part is removed perineally. 10

Claims (11)

image 1 1. Endoscopic device (1) for the perineal approach to rectal cancer, comprising a circular endoscopic tube (2) and a cap (3) attachable to a proximal end of the endoscopic tube (2), characterized in that the diameter of the tube (2) is larger than the diameter of a patient's rectum and because an inner portion (3a) of the cap (3) is rotatable relative to an outer portion (3b) of said cap (3) that is attachable to the tube (2 ) endoscopic, the inner portion (3a) of the cover (3) comprising a central port (4) provided with a spherical joint (5) to which a conduit (6) is attached to accommodate an optical means 10 display and a plurality of working peripheral ports (7) for the introduction of laparoscopic instruments. 2. Device (1) according to claim 1, wherein the endoscopic tube (2) has a diameter between 7 cm and 14 cm and a length between 10 cm and 17 cm. fifteen 3. Device (1) according to any of the preceding claims, wherein the peripheral ports (7) are located at a distance between 3 cm and 7 cm from the center of the cover (3). A device (1) according to any one of the preceding claims, comprising four working peripheral ports (7). 5. Device (1) according to any of the preceding claims, wherein the Peripheral ports (7) comprise rubber sleeves (13) with valves to prevent CO2 leakage. Device (1) according to claim 5, wherein the sleeves (13) are formed by a rubber or rubber cylinder provided with a pair of diametral circular flanges for coupling to the corresponding peripheral port (7). 30 7. Device (1) according to any of the preceding claims, further comprising means for immobilizing the inner portion (3a) of the lid (3) in various rotational positions relative to the outer portion (3b). Device (1) according to any one of the preceding claims, further comprising the optical display means housed in the conduit (6), wherein the means eleven image2 Optical display comprises a telescopic tube equipped with a viewing optics and a light source. 9. Device (1) according to claim 8, wherein the optical display means 5 is connectable to an HD or 3D camera that allows the visualization of the images obtained through a monitor. 10. Device (1) according to any of the preceding claims, wherein the Endoscopic tube (2) further comprises a first auxiliary port (8) for the insufflation of 10 CO2 and a second auxiliary port (9) for smoke extraction. 11. Device (1) according to any of the preceding claims, further comprising an articulated mechanism (10) having a first end attachable to the endoscopic tube (2) and a second end attachable to a surgical table. fifteen 12. Device (1) according to any of the preceding claims, further comprising an adhesive ring (12) attachable to the distal end of the endoscopic tube (2) to minimize CO2 leakage. 13. Device (1) according to claim 12, wherein the adhesive ring (12) is made of one of the materials in the following list: rubber, foam, gel, and a combination thereof. 14. Device (1) according to any of the preceding claims, wherein the diameter of the peripheral ports (7) is between 1.5-3 cm. 12