WO2018203277A1

WO2018203277A1 - Colorectal surgery device with washing means

Info

Publication number: WO2018203277A1
Application number: PCT/IB2018/053085
Authority: WO
Inventors: Fabio RONDELLI
Original assignee: Rondelli Fabio
Priority date: 2017-05-05
Filing date: 2018-05-03
Publication date: 2018-11-08
Also published as: IT201700048798A1

Abstract

The surgical device (1) comprising at least two branches (2) provided with: respective gripping extremities (3) associable with one another to define a handle of the device (1); and respective closing extremities (5) having a predefined direction of extension (12) and adapted to clamp portions of organs and tissues, with the branches (2) that are articulated to one another for the mutual approaching and moving away of the closing extremities (5), - washing means (8, 16) adapted to drain at least one washing liquid (L) in the organs and tissues when the closing extremities (5) are approached with one another.

Description

COLORECTAL SURGERY DEVICE WITH WASHING MEANS Technical Field

The present invention relates to a surgical device for colorectal surgery.

Background Art

The need to be able to carry out washing operations during colorectal surgery is well known, both in general surgery and in oncological surgery.

In general surgery, it is often necessary to free the colon lumen from hardened feces or other material which would prevent the operation from being performed correctly.

In oncological surgery, on the other hand, washing operations are becoming increasingly more important inasmuch as they are crucial in reducing the risk of local recurrences following resections and mechanically created anastomoses. Local recurrence, in fact, is associated with a reduction in long-term survival and in the quality of the remaining life of the patient and is also a clinical problem to be addressed (subsequent surgery and/or chemotherapy), with considerable costs for the healthcare system.

Colorectal surgery involves the use of enterostomy devices to close the lumen of the colorectal in two sections in order to isolate the portion of tissue to be removed and mechanical staplers in order to anastomize the remaining tissue. Local recurrence occurs in a significant number of patients, particularly after the mechanical creation of anastomoses in the portion below the stump to be removed.

A large body of scientific evidence shows that the local recurrence can be linked to the implantation of exfoliated tumor cells inside the intestinal lumen.

Repeated studies have shown that the washing of the lower rectal stump, where the anastomosis is created, if conducted with cytotoxic agents and with adequate quantities of liquid (by means of the simple mechanical action of washing), leads to a statistically significant reduction in terms of local recurrence.

Proper colorectal washing can be decisive in reducing the risk of recurrence and, therefore, in improving the life of the patient and lowering health costs for the community.

To date, washing operations are not systematically carried out. In some cases they are carried out trans-anally by an assistant of the operator surgeon, with washing liquids that are diffused in the opposite direction to the oral-aboral direction, i.e. anti-peristaltic.

In the case of minimally invasive surgery (laparoscopic and/or robotic), colon lumen washing is not always performed because it may require more extensive incisions than those normally required and/or to be performed in unconventional sites for the type of operation.

In this treatise, the term minimally invasive surgery comprises all surgical operations which use the methods and techniques of surgery aimed at minimizing the trauma related to the incision of the wall of the area involved, such as laparoscopic methods and robotic techniques.

In the light of the above, the need is known to be able to facilitate the learning and implementation of colon lumen washing techniques in order to reduce the risk of local post anastomotic recurrence or in order to remove hardened fecal matter from the colon lumen.

Description of the Invention

The main aim of the present invention is to provide a surgical device for colorectal surgery that allows carrying out washing operations in different types of operations.

One object of the present invention is to provide a surgical device for colorectal surgery that allows promoting the spread and learning of the washing techniques.

Another object of the present invention is to provide a surgical device for colorectal surgery that is simple to use in the case of operations and can be easily sterilized.

Another object of the present invention is to provide a surgical device for colorectal surgery which allows overcoming the aforementioned drawbacks of the prior art in the field of a simple, rational, easy, effective to use and low cost solution.

The aforementioned objects are achieved by the present surgical device for colorectal surgery having the characteristics of claim 1.

Brief Description of the Drawings Other characteristics and advantages of the present invention will become clearer from the description of the following preferred but not exclusive embodiments of a surgical device for colorectal surgery, illustrated by way of non-limiting example in the accompanying drawings, wherein:

Figure 1 is an axonometric view of a first embodiment of the device according to the invention;

Figure 2 is an axonometric view of a detail of a first embodiment of the device according to the invention;

Figures 3 to 4 are axonometric views of details of a second embodiment of the device according to the invention;

Figures 5 and 6 are sectional views of a detail of a second embodiment of the device according to the invention;

Figure 7 is an axonometric view of a detail of a third embodiment of the device according to the invention;

Figure 8 is an axonometric view of a detail of a fourth embodiment of the device according to the invention;

Figure 9 is an axonometric view of a fifth embodiment of the device according to the invention;

Figure 10 is an axonometric view of a sixth embodiment of the device according to the invention;

Figure 11 is a schematic view of a use of the device according to the invention. Embodiments of the Invention

With particular reference to these figures, reference numeral 1 globally indicates a surgical device for colorectal surgery.

According to a first embodiment, the device 1 comprises at least two branches 2 provided with respective gripping extremities 3 associable with one another to define a handle of the device 1.

The gripping extremities 3 each have a ring-shaped head so as to allow an operator to hold and grip the device 1 by inserting two opposing fingers into the gripping extremities 3 themselves.

Usefully, the gripping extremities 3 have respective racks 4 engageable in one another to keep the branches 2 in position according to their degree of opening. The two branches 2 are also provided with respective closing extremities 5 having a predefined direction of extension 12 and adapted to clamp portions of organs and tissues.

The branches 2 are articulated to one another for the mutual approaching and moving away of the closing extremities 5.

Such characteristic allows the device 1 to act as an enterostomy device, the operator being able to approach the closing extremities 5 by clamping portions of organs, e.g., by clamping portions of the intestine in order to be able to operate on a section subsequent to the closed portion.

According to the invention, the device 1 comprises washing means 8, 16 adapted to drain at least one washing liquid L in the organs and tissues when the closing extremities 5 are approached with one another.

Such characteristic allows washing the portion of organs and/or tissues distally to the section closed by the closing extremities 5.

In case of operations on portions of intestine and/or colon-rectum (Figure 11), if suitably positioned, the device 1 allows clamping a portion of the organ 6 and washing the distal portion in the oro-aboral direction 7.

Preferably, the washing means 8, 16 comprise at least one conveying member 8 in which the washing liquid L is conveyable.

The conveying member 8 is associated with at least one of the closing extremities 5 and has a conveying surface 9 facing the other closing extremity 5.

Usefully, the conveying member 8 has a tubular shape with a circular section, but tubular shapes with different sections or solutions which provide for different conformations cannot be ruled out, e.g., refilling tanks or other solutions adapted to convey the washing liquid.

The conveying member 8 is provided with a refilling head 10 with which is associable a tube 11 into which the washing liquid L flows, or into which a generic refilling device is insertable in which the liquid itself is stored.

Usefully, the washing means comprise two conveying members 8, each associated with a closing extremity 5 and each having a conveying surface 9 facing the other closing extremity 5. Different solutions cannot be ruled out wherein the washing means comprise a single conveying member 8, or several conveying members 8 associated with a single closing extremity 5.

In the first embodiment, the conveying member 8 extends along a direction substantially parallel to the direction of extension 12.

In particular, the direction of extension 12 is substantially straight.

As shown in Figures 1 and 2, the closing extremities 5 are elongated in the straight direction of extension 12, with the conveying member 8 which follows the pattern thereof.

The device 1 shown in a first embodiment (Figures 1 and 2) comprises a conveying member 8 integrated on at least one closing extremity 5.

The washing means 8, 16 comprise at least one nozzle 16 associated with the conveying member 8 to drain the washing liquid and is adapted to perforate the organs and/or fabrics when the closing extremities 5 are approached with one another.

The nozzle 16, in fact, extends overhanging from the conveying surface 9.

This way, by bringing the closing extremities 5 closer to clamp a portion of organ, the nozzle 16 is pushed against the wall of the organ itself to apply a pressure such as to perforate it.

Usefully, the nozzle 16 has a pointed perforation extremity 17 and a substantially circular cross-section, having a radius smaller than the dimensions of the cross section of the conveying member 8.

Conformations of the nozzle 16 different from those shown in the figures cannot be ruled out.

Advantageously, the washing means 8, 16 comprise a plurality of nozzles 16.

In particular, the nozzles 16 are substantially aligned to define on the conveying surface 9 a line substantially parallel to the conveying member 8.

Different positions of the nozzles 16, e.g. positioning on multiple rows, or staggered positioning cannot be ruled out.

The direction of extension 12 shown has a straight pattern, but a different pattern cannot be ruled out.

In this first embodiment, the device 1 can be used both in the field of open surgery and in the field of minimally-invasive surgery (laparoscopic and/or robotic).

The operation of the present invention is as follows.

An operator can grip the device 1 by inserting his/her fingers into the gripping extremities 3 and vary the opening angle of the branches 2 in order to move the closing extremities 5 nearer or away.

The rack 4 allows temporarily fixing the opening angle of the branches 2.

By moving the closing extremities 5 to the walls of the organ or tissue to be operated on, a portion of the organ or tissue can be clamped by moving the closing extremities 5 closer.

In this position, the nozzles 16 press against the walls of the organ or tissue, penetrating it and putting in communication the inside of the organ or tissue with the conveying member 8.

By making a washing liquid L flow through the conveying members 8, the liquid itself flows out of the nozzles 16 and into the portion of the organ or tissue adjacent to the clamped portion.

In the specific case of operation on the intestine and/or on the colon-rectum, shown in Figure 11, by positioning the device 1 with the closing extremities 5 upstream of the nozzles 16 with respect to the oro-aboral direction 7, the stump of organ distal to the clamped section can be washed, allowing the washing liquid L to come out without it going back with respect to the oro-aboral direction 7.

In a second embodiment (Figures 3, 4 and 5), the device 1 comprises attachment means 13, 14 of the conveying member 8 to at least one of the closing extremities 5. The attachment means 13, 14 are adapted both to hold the conveying member 8 at the closing extremity 5 and to allow the removal of the conveying member 8 by a user.

This characteristic is useful for replacing a used conveying member 8 and allowing reusing the device 1 by applying a new conveying member 8.

In this embodiment, in fact, the conveying member 8 and the nozzles 16 form a single body piece which engages at least one of the closing extremities 5 by means of suitable attachment means 13, 14. In particular, the attachment means 13, 14 comprise a housing seat 13 formed on the closing extremity 5.

The attachment means 13, 14 themselves comprise an insertion member 14 locked together with the conveying member 8.

The insertion member 14 is insertable into the housing seat 13 to form a prismatic coupling.

Usefully, as shown in Figure 5, the profile of the section of the insertion member 14 and of the housing seat 13 has two inclined opposite sides 15, converging with respect to one another from the inside towards the outside of the closing extremity 5.

Solutions cannot be ruled out in which there are different profiles of the section of the insertion member 14.

Figure 6 shows for example some different profiles of the section of the insertion member, in particular a rectangular section, a circular section and a section with knurls adapted to increase the contact surface between the member 14 and the seat 13.

The alternative solution in which the housing seat 13 is formed on the conveying member 8 and the insertion member 14 is formed on the closing extremity 5 cannot be ruled out.

The solution cannot also be ruled out that provides alternative attachment means, e.g. hooks, clips, or other elements adapted to hold the conveying member 8 on the closing extremity 5 while allowing the removal thereof.

Similarly to the first embodiment, also in the second embodiment the washing means 8, 16 comprise at least one nozzle 16 associated with the conveying member 8.

The nozzle 16 communicates with the conveying member 8 to drain the washing liquid and is adapted to perforate the organs and tissues when the closing extremities 5 are close together.

The nozzle 16, in fact, protrudes cantilevered from the conveying surface 9. This way, when the closing extremities 5 move closer to clamp a portion of the organ, the nozzle 16 is pushed against the wall of the organ itself to apply a pressure such as to perforate it. Usefully, the nozzle 16 has a pointed perforation extremity 17 and a substantially circular cross-section, having a radius smaller than the dimensions of the cross-section of the conveying member 8.

Advantageously, the washing means 8, 16 comprise a plurality of nozzles 16. In particular, the nozzles 16 are substantially aligned to define on the conveying surface 9 a line substantially parallel to the conveying member 8.

Different positions of the nozzles 16 cannot be ruled out, e.g. positioning on multiple rows, or staggered positioning.

The operation of the second embodiment described is completely identical to the operation of the first embodiment.

In this case, once the operation has terminated, by removing the insertion members 14 from their respective seats 13, the conveying members 8 can be removed from the closing extremities 5 to be replaced with new conveying members.

Figure 7 shows a third embodiment of the device according to the invention. The third embodiment is completely identical to the previously described embodiments, whose detailed description is referred to in its entirety.

The device 1 illustrated in the third embodiment differs from the previous embodiment in that the conveying member 8 comprises a head member 8 a, locked together with the respective closing extremity 5, and a nozzle member 8b, which is associated with the head member 8a in a removable manner.

The refilling head 10 is part of the head member 8a.

The nozzles 16 are arranged on the nozzle member 8b.

This solution permits facilitating the replacement of the nozzles 16 by simply detaching the part of member 8b from the part of member 8a.

This way, only one part of the conveying member 8 can be decoupled from the closing extremity 5, leaving the rest of the conveying member 8 and the refilling head 10 locked together with the closing extremity 5.

Such characteristic allows replacing, with a single operation, all the nozzles 16 which, following the operation, are subject to wear and tear with a consequent reduction of perforating capacity as well as being subject to obstruction with organic matter which could make subsequent cleaning and sterilizing operations difficult.

As shown in figure 7, the nozzle member 8b can be fitted in/removed from the rest of the conveying member 8 in the specific detachment seat 22 obtained on the head member 8a.

Solutions cannot be ruled out whereby the nozzle member 8b is inserted under pressure or slotted into the seat 22.

The operation of the device 1 in the above-described third embodiment is completely identical to the operation of the previous described embodiments.

In the third embodiment, only the nozzle member 8b, after use, can be replaced with a new nozzle member 8b to facilitate re-use of the device 1.

A fourth embodiment, shown in Figure 8, cannot be ruled out in which the conveying member 8 is welded to the closing extremity 5, defining a single body piece with it.

In particular, the conveying member 8 is irremovable with respect to the closing extremity 5.

Advantageously, in the fourth embodiment, the nozzles 16 are removable from the conveying member 8.

This characteristic permits replacing the nozzles 16 one by one which, following the operation, are subject to wear and tear with a consequent reduction in perforating capacity, as well as being subject to obstruction with organic matter that could make subsequent cleaning and sterilizing operations difficult.

As shown in Figure 8, the nozzles 16 can be fitted in/removed from the conveying surface 9.

Usefully, the nozzles 16 can be screwed into special seats 18 obtained on the conveying surface 9, but solutions cannot be ruled out which provide for the insertion under pressure or slotting in of the nozzles 16 on the conveying surface 9.

The operation of the device 1 in the above-described fourth embodiment is completely identical to the operation of the third embodiment, with the exception that the nozzles 16 are inserted or disconnected individually by the conveying member 8.

Figure 9 shows a fifth embodiment of the device according to the invention. The fifth embodiment is completely identical to the previous embodiments, whose detailed description is referred to in its entirety.

The device 1 illustrated in the fifth embodiment differs from the previous embodiments in that it has a different direction of extension 12 of the closing extremities 5.

In particular, the direction of extension 12 is substantially curved.

Such characteristic permits facilitating operations in areas where it is not easy to operate because they are difficult to access, such as pelvic areas.

In the embodiment shown in Figure 9, the direction of extension 12 is of the type of a continuous curve, but solutions cannot be ruled out which provide for a direction of extension defined by one or more segments inclined the one to the other, e.g., to define a "T" curve or a polygonal curve.

The operation of the fifth embodiment is completely identical to the previous ones.

Figure 10 illustrates a sixth embodiment of the device according to the invention.

The sixth embodiment is completely identical to the previous embodiments, whose detailed description is referred to in its entirety.

The device 1 shown in the sixth embodiment differs from the previous embodiments in having an elongated portion 19 interposed between at least one closing extremity 5 and at least one gripping extremity 3.

In particular, the device 1 comprises an elongated portion 19 interposed between the closing extremities 5 and the gripping extremities 3 and adapted to be inserted into a hole made on a patient undergoing laparoscopy.

This characteristic permits spacing the closing extremities 5 apart from the gripping extremities 3 so as to be able to insert the closing extremities 5 inside the body of a patient, leaving the gripping extremities 3 sufficiently distant from the patient.

In this embodiment, the branches 2 comprise articulation means 20 adapted to mechanically connect the closing extremities 5 to the gripping extremities 3. Usefully, the articulation means 20 are of the type of motion transfer systems known to the state of the art, adapted to open/close the closing extremities 5 according to the degree of opening of the gripping extremities 3.

Figure 10 shows an operating body 21 located at the gripping extremities 3, adapted to remotely adjust the inclination and/or orientation of the closing extremities 5.

Advantageously, the elongated portion 19 is of the type of an elongated tube which at least partially wraps the articulation means 20.

The elongated portion 19 follows the closing extremities 5 so the device 1 can be inserted into a hole normally made in a patient undergoing minimally- invasive surgery (laparoscopic and/or robotic).

The operation of the device 1 in the above-described sixth embodiment is completely identical to the operation of the previous embodiments.

In the sixth embodiment, the closing extremities 5 with the conveying members

8 and the nozzles 16 can be inserted into a hole made on a patient undergoing minimally- invasive surgery (laparoscopic and/or robotic).

The elongated portion 19 follows the closing extremities 5 and is inserted at least partly into the aforementioned hole.

This way, the gripping extremities 3 are sufficiently distant from the patient's body to enable an operator to easily perform opening and closing operations.

The operator, thanks to the articulation means 20, can move the closing extremities 5 nearer/further away to clamp portions of organ or tissue by simply opening/closing the gripping extremities 3.

Furthermore, the operator, by means of the operating body 21, can adjust in advance the inclination and orientation of the closing extremities 5.

In all of the previously-described embodiments, the device 1 is made from materials traditionally used in the manufacture of surgical instruments, in particular stainless steel, chrome-plated metals, titanium or plastic materials. In particular, the device 1 can be made entirely from biodegradable and/or bio- compostable plastics.

This solution would make it possible to obtain a disposable device 1 which, once used, can be discarded directly.

It has in practice been found that the described invention achieves the intended objects and in particular the fact is underlined that the surgical device for colorectal surgery allows carrying out washing operations in various types of operation.

In fact, the provided device can be used both in traditional "open" surgery and in minimally- invasive surgery (laparoscopic and/or robotic).

The provided device also facilitates the spread and learning of the washing techniques inasmuch as it is easily usable in known surgical procedures.

The device, in fact, has a conformation and functionality such as to make it an easy replacement for traditional enterostomy devices.

This way, washing techniques can be easily spread, because the known enterostomy devices can be replaced with the new device, without increasing operating time and costs.

Finally, the provided surgical device is easy to prepare in case of operations and easily sterilized.

The removable conveying member and/or nozzle set enable the operator to easily replace those parts of the instrument that are both wearable and potentially blockable by organic matter.

The removable parts can be discarded, eliminating time-consuming and costly subsequent nozzle or conveying member sterilization steps.

This way sterilization would only be required for the articulated branches, with simpler and less expensive operations than those required for cleaning and sterilization of removable parts.

Claims

1) Surgical device (1) comprising at least two branches (2) provided with:

respective gripping extremities (3) associable with one another to define a handle of said device (1); and

- respective closing extremities (5) having a predefined direction of extension (12) and adapted to clamp portions of organs and tissues;

said branches (2) being articulated to one another for the mutual approaching and moving away of said closing extremities (5), characterized by the fact that it comprises washing means (8, 16) adapted to drain at least one washing liquid (L) in said organs and tissues when said closing extremities (5) are approached with one another.

2) Device (1) according to claim 1, characterized by the fact that said washing means (8, 16) comprise:

at least one conveying member (8) in which is conveyable said washing liquid (L), associated with at least one of said closing extremities (5) and having a conveying surface (9) facing the other of said closing extremities (5);

at least one nozzle (16) associated with said conveying member (8), communicating with the same conveying member (8) to drain said washing liquid (L) and adapted to perforate said organs and fabrics when said closing extremities (5) are approached with one another.

3) Device (1) according to one or more of the preceding claims, characterized by the fact that said conveying member (8) extends along a direction substantially parallel to said direction of extension (12).

4) Device (1) according to one or more of the preceding claims, characterized by the fact that said nozzle (16) extends overhanging from said conveying surface (9).

5) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises attachment means (13, 14) of said conveying member (8) to at least one closing extremity (5) of said closing extremities (5).

6) Device (1) according to one or more of the preceding claims, characterized by the fact that said attachment means (13, 14) comprise a housing seat (13) formed on at least one of said closing extremity (5) and said conveying member (8).

7) Device (1) according to one or more of the preceding claims, characterized by the fact that said attachment means (13, 14) comprise at least one insertion member (14) locked together with at least the other of said closing extremity (5) and said conveying member (8) and insertable into said housing seat (13) to form a prismatic coupling.

8) Device (1) according to one or more of the preceding claims, characterized by the fact that said nozzle (16) is removable from said conveying member (8). 9) Device (1) according to one or more of the preceding claims, characterized by the fact that said washing means (8, 16) comprise a plurality of said nozzles (16).

10) Device (1) according to one or more of the preceding claims, characterized by the fact that said conveying member (8) comprises a head member (8a) locked together with said closing extremity (5), and a nozzle member (8b) which is associated in a removable manner with said head member (8a), said nozzles (16) being arranged on said nozzle member (8b).

11) Device (1) according to one or more of the preceding claims, characterized by the fact that said direction of extension (12) is substantially straight.

12) Device (1) according to one or more of claims 1 to 10, characterized by the fact that said direction of extension (12) is substantially curved.

13) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises an elongated portion (19) interposed between said closing extremity (5) and said gripping extremity (3) and adapted to be inserted into a hole made on a patient to be subjected to mini-invasive surgery with said branches (2) comprising articulation means (20) adapted to mechanically connect said closing extremities (5) to said gripping extremities (3).