WO2022044055A1

WO2022044055A1 - Surgical retractor device

Info

Publication number: WO2022044055A1
Application number: PCT/IT2021/050264
Authority: WO
Inventors: Gian Luigi ADANI; Umberto BACCARANI; Vittorio CERCHI
Original assignee: Universita' Degli Studi Di Udine; Azienda Sanitaria Universitaria Friuli Centrale
Priority date: 2020-08-27
Filing date: 2021-08-20
Publication date: 2022-03-03
Also published as: IT202000020512A1

Abstract

Surgical retractor device (10) able to retract a surgical incision up to a desired diameter. Said device (10) comprises a first ring (11), a second ring (12) and a flexible protective membrane (13) disposed between said first ring (11) and said second ring (12), and a plurality of supports (14) able to be selectively coupled to said first ring (11) and able to support respective retractor elements (15).

Description

“SURGICAL RETRACTOR DEVICE”

FIELD OF THE INVENTION

The present invention concerns a surgical retractor device that can be used during surgery performed with the so-called open technique (laparotomy or “open”). This device can be used when performing abdominal, urological, gynecological or orthopedic surgery, transplants, or other.

The device can also be used in the veterinary field.

BACKGROUND OF THE INVENTION

It is known that during surgery performed with the “open” technique, that is, in which an incision is made to access the surgical cavity where the intervention is carried out, particular instruments are required to retract the margins of the surgical incision in order to increase visibility of the operating field.

One of the most recent and used surgical retractor instruments comprises two rings joined together by a protective membrane made of plastic material, peripherally attached to both rings.

A first ring, rigid, remains outside the surgical incision while a second, softer ring is positioned inside the surgical incision in contact with an internal surface of the wall through which the incision is made.

Through a mechanism of manual rotation of the first ring, or external ring, on the second ring, or internal ring, a traction force is created that allows a constant and stable retraction of the incision for the entire duration of the intervention. During the retraction action, the protective membrane adheres to the perimeter edge of the incision, from the outside to the inside.

One disadvantage of this known device is that often the simple retraction of the incision generated by the rotation of the external ring is not in itself sufficient, since the retraction function only affects the margins of the incision; in order to move the organs or structures located before the site of the intervention itself, it is often necessary to use specific retractors - known as retraction valves.

The most commonly used retraction valves can be of different type, shape, length, diameter and material, but they all have the disadvantage of having to be manually manipulated by the surgeons present at the operating table. Furthermore, since they are not fixed, they do not allow to have a stable and well- defined operating field over time.

To overcome this problem, there are surgical retractor devices of a static or fixed type that allow both to retract the surgical incision through wall valves, and also to use fixed retraction valves for internal organs or structures.

These fixed retractor devices generally comprise a kit consisting of rods attached to the operating bed, rings of various diameters or arms to be positioned outside the surgical incision provided with hooks to which wall and organ retraction valves are connected.

One disadvantage of these fixed retractor devices is that they are not able to protect the abdominal wall from trauma and infections. Furthermore, this method of retracting the surgical incision by means of a valve does not make the traction homogeneous over the entire surface of the incision, as happens instead for the device with rings, which is conformed to act in a circular manner and therefore with the same traction force on the entire perimeter of the surgical incision.

To overcome this deficiency, in some cases an attempt is made to use both devices, the one with rings and the fixed one, during the same operation.

The main problem with this approach is that, since the two devices have not been designed to work together, not only does the combined approach not optimize the function of both, but also the overall bulk at the operating table is further increased.

Furthermore, from the management point of view, static retractor devices are multipurpose, unlike those with rings, and, after use, they need to be re-sterilized.

Furthermore, static retractor devices are very expensive and therefore can be found in a very limited number in a surgical department, typically even just one. It is therefore extremely difficult to be able to use both devices on the same day or in multiple operating theatres.

Document US-B-6,254,533 describes a protective surgical apparatus for wounds, in order to provide protective support for an incision and support for a surgical apparatus used inside the incision.

Documents US-A-2005/209510 describes a retractor device for wounds of a known type.

Document UA-A-2006/0074278 describes a tissue retractor able to produce a widened working channel. There is therefore a need to perfect a surgical retractor device that can overcome at least one of the disadvantages of the state of the art.

In particular, one purpose of the present invention is to provide a retractor device able both to retract the surgical incision homogeneously and protect it, and also to retract the organs by means of fixed retraction valves, accurately exposing the site of the intervention.

Another purpose of the present invention is to provide a retractor device that is simple to use, extremely economical and very versatile.

Another purpose of the present invention is to provide a retractor device that is not bulky and allows the surgeon to have both hands completely free to operate.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claim. The dependent claims describe other characteristics of the present invention or variants to the main inventive idea.

In accordance with the above purposes, a surgical retractor device able to retract a surgical incision up to a desired diameter, which overcomes the limits of the state of the art and eliminates the defects present therein, comprises:

- a first ring and a second lower ring, connected by a tubular shaped flexible protective membrane, which has a first extended condition and a second radially retracted condition, achieved by the first flexible ring winding around itself, around its own axis of annular development and able to retract a surgical incision up to a desired diameter;

- a plurality of supports releasably coupled to the first ring by means of a respective specialized coupling portion, mating in shape with the cross section of the first ring, each of these supports being able to support a respective retractor element mobile at least linearly, in a radial direction with respect to the first flexible ring, and configured to displace and maintain retracted organs and/or anatomical structures covering a specific site of the surgical procedure.

According to one aspect of the present invention, each support comprises a gripper having a gripping portion in which there is defined a gripping seating mating in shape with the shape of at least a more external part of the cross section of the first ring.

According to one variant, each support comprises a gripper, having a gripping portion in which there is defined a gripping seating, and a connection element having a coupling portion, in which there is defined a coupling seating mating in shape with the shape of at least a more external part of the cross section of the first ring, and an opposite connection portion mating in shape with the gripping seating.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

- fig. 1 is a lateral view of a surgical retractor device in accordance with embodiments described here;

- fig. 2 is a top view of fig. 1 ;

- fig. 3 is a section along line III-III of fig. 2;

- fig. 4 shows the surgical retractor device of fig. 1 during use;

- fig. 5 is an enlarged detail of fig. 1 ;

- fig. 6 is a variant of fig. 5;

- fig. 7 is a variant of fig. 5 in which the support comprises the connection element;

- figs. 8-9 are variants of fig. 7.

To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can conveniently be combined or incorporated into other embodiments without further clarifications.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

We will now refer in detail to the possible embodiments of the invention, of which one or more examples are shown in the attached drawings, by way of a non-limiting illustration. The phraseology and terminology used here are also for the purposes of providing non-limiting examples. Embodiments described here concern a surgical retractor device, hereafter for simplicity device, 10 able to retract a surgical incision up to a desired diameter so that the surgeon in charge has sufficient operating space to perform surgery.

The surgical incision can be performed on a human or an animal body and, depending on the type of surgery - laparotomic or “open” - general, transplant, urological, gynecological, orthopedic or other - it is performed on a well-defined tissue wall 100 of the body.

The surgical incision defines, with respect to the wall 100 on which it is made, a respective internal side and an external side of the body.

Here and hereafter in the description, the terms “internal” and “external” refer, therefore, to the position of a determinate component, outside or inside the body, with respect to the wall 100 on which the surgical incision is made.

The device 10 comprises a first upper flexible ring 11 having a respective first diameter DI greater than the desired diameter of the incision and able to be disposed, during use, outside the surgical incision. In particular, the first ring 11 can be positioned in contact with an external surface of the wall through which the incision is made.

The device 10 comprises a second lower flexible ring 12 having a respective second diameter D2 greater than the desired diameter of the incision, preferably smaller than the first diameter DI, and able to be disposed, during use, inside the surgical incision. In particular, the second ring 12 is positioned in contact with an internal surface of the wall through which the incision is made.

The device 10 comprises a flexible protective membrane 13 having a tubular shape and peripherally associated with the first ring 11 and with the second ring 12, defining their connection. Before applying the device 10 to the surgical incision, the protective membrane 13 is in a substantially loose condition, fig. 1.

The protective membrane 13 can be attached to the first ring 11 and to the second ring 12 in a known manner, for example by gluing or by heat sealing.

The first ring 11 develops along its own annular axis X, or axis of annular development, and is configured to be rotated on itself around the annular axis X to give the protective membrane 13 a radial retraction sufficient to retract the surgical incision up to the desired diameter.

In particular, by rotating the first ring 11 on itself around the annular axis X, an upper end of the protective membrane 13 gradually winds around the first ring 11 so that the protective membrane 13 adheres firmly to the edges of the incision, exerting a traction force that causes the desired retraction. For example, it is possible to provide that with each rotation of the first ring 11 there is obtained a determinate increase in the retraction of the surgical incision.

The protective membrane 13 therefore has a first extended condition (fig, 1 ) and a second radially retracted condition (fig. 4), achieved by the first ring 11 winding around itself, around its own axis of annular development X.

According to one aspect of the present invention, the device 10 comprises a plurality of supports 14 releasably coupled to the first ring 11 by means of a respective specialized coupling portion 18, 22 and able to support respective retractor elements 15.

The retractor elements 15 are linearly mobile, in a radial direction with respect to the first ring 11 , and are provided with a respective front gripping portion 16 configured to displace and maintain in the desired position organs and/or anatomical structures that are covering the site of the surgical procedure.

The second ring 12 can, therefore, be made of a material particularly suitable for contact, even prolonged, with the internal walls of the body, while the first ring 11 is made of a material suitable to allow both its rotation, as just described, and also the attachment of the supports 14.

The device 10 allows to retract the surgical incision in a stable, homogeneous and desired manner, in order to prevent/avoid possible infections thanks to the presence of the protective membrane 13 and, moreover, to retract organs and/or structures that may obstruct access to the surgical site. In addition, once the desired diameter of the surgical incision has been established and the obstructing organs and/or anatomical structures have been retracted, the surgeons at the operating table have both hands free to perform surgery.

In possible embodiments, the supports 14 can be suitably configured to also support other surgical instruments different and distinct from the retractor elements 15.

According to some embodiments, the specialized coupling portions 18, 22 are respectively a gripping portion 18 and a coupling portion 22.

According to some embodiments, each support 14 comprises a gripper 17 provided with the gripping portion 18 and clamping means 19 configured to clamp the support 14 in a stable and desired position on the first ring 11, and possibly also to clamp the respective retractor element 15 in position.

According to some embodiments, the support 14, in particular the gripper 17, can be associated with the first ring 11 directly (figs. 5-6) or indirectly (figs. 7-9).

The gripping portion 18 is made in a single piece, that is, it is integral with the gripper 17 of the support 14.

According to some embodiments, the gripper 17 comprises an upper gripping element 17a and an opposite and facing lower gripping element 17b.

The upper gripping element 17a and the lower gripping element 17b are specular with respect to a central gripping axis Y.

The central gripping axis Y is orthogonal to the annular axis X and has a radial direction toward the center of the first ring 11.

According to possible embodiments, the central gripping axis Y and the annular axis X are placed on respective lying planes parallel to each other, possibly even coincident.

According to other embodiments, the gripping axis Y lies on a respective lying plane that is inclined toward the inside of the first ring 11 and with respect to the lying plane that contains the annular axis X.

According to other embodiments, the gripping axis Y lies on a plane orthogonal to a plane defined by the annular axis X of the first ring 11 , that is, to the lying plane of the annular axis X.

According to some embodiments, the gripping portion 18 is mating in shape with the shape of at least a more external part of the first ring 11 so as to allow the gripper 17 to be clamped directly on it, figs. 5-6. The gripping portion 18 therefore configures a coupling on the first ring 11.

The gripping portion 18 has a gripping seating 20, half of which is defined by an upper shaped surface 18a of the upper gripping element 17a and the other half by an opposite lower shaped surface 18b of the lower gripping element 17b.

At least in the case of direct coupling of the gripper 17 on the first ring 11, the gripping seating 20 has a shape mating with the shape of at least a more external part of a cross section A of the first ring 11.

According to other embodiments, the support 14 comprises a connection element 21 that can be selectively associated with the gripping portion 18 of the gripper 17 on one side, and with the first ring 11 on the opposite side, figs. 7-9.

The connection element 21 is a distinct and separate component from the gripper 17 of the support 14 and allows an indirect coupling of the gripper 17 on the first ring 11. In this sense, the connection element 21 is configured as a size and sha Ane adan ± ter.

The connection element 21 has the coupling portion 22, having a shape mating with the shape of at least a more external part of the first ring 11 in order to be firmly clamped thereon, and an opposite connection portion 23, having a shape mating with the shape of the gripping portion 18, in particular of the gripping seating 20. In this case, the gripping seating 20 can even have a shape different from the cross section A of the first ring 11.

The coupling portion 22 can have a limited circumferential extension, for example coherent with a size in width of the gripper 17, or it can have an even wider circumferential extension, which in the most extreme case can consist of the entire circumferential band of the first ring 11.

The connection element 21 comprises an upper wall 21a and an opposite lower wall 21b, both of which can have a more or less wide circumferential extension.

The upper wall 21a and the lower wall 21b define, at the front part, the coupling portion 22 which has an aperture to allow the insertion of the first flexible ring 11.

The upper wall 21a and the lower wall 21b have, at the rear part, a respective segment converging toward the central gripping axis Y and a respective segment diverging from the central gripping axis Y defining a bulb 21c conformed to be inserted in the gripping seating 20.

The upper wall 21a and the lower wall 21b can be sufficiently flexible so as to facilitate the insertion of the connection element 21 on the first ring 11 through the aperture.

The coupling portion 22 has a coupling seating 24, half of which is defined by an upper shaped surface 22a of the upper wall 21a, and the other half by an opposite lower shaped surface 22b of the lower wall 21b.

According to some embodiments, the connection portion 23 can have a substantially standardized and fixed size, while the coupling portion 22 can have a length L sufficient to define a radial extension of the support 14 which allows the respective retractor element 15 to apply a greater force on the first flexible ring 11 necessary for retractions with greater resistance, fig. 8.

According to possible embodiments, the length L can vary between about 1cm and about 7cm.

According to some embodiments, the gripping seating 20 of the gripping portion 18, at least if the use of the connection element 21 is not provided, and the coupling seating 24 of the coupling portion 22 can have a profile at least partly complementary to the profile of the cross section A of the first ring 11.

The profile can be curved or polygonal. The curved profile can be, for example, an arc of a circumference, an arc of an ellipse or a branch of a parabola or other curve or combination of curves.

The gripping seating 20 of the gripping portion 18 and the coupling seating 24 of the coupling portion 22 can have the curved or polygonal profile as above, possibly in different sizes since the size of the cross section A of the first ring 11 can vary, in intervals, depending on the size of the diameter DI.

According to possible embodiments, the device 10 can comprise one or more annular shells associated with the first ring 11, for example with the purpose of stiffening it. In this case, the supports 14 can be indirectly associated with the first ring 11 by means of the annular shells.

According to possible embodiments, the support 14 can be able to be oriented so that the gripping axis Y, or central gripping axis, is inclined with respect to a plane defined by the annular axis X of the first ring 11 , so that the retractor element 15 can be directed toward the inside of the body in order to reach deeper zones, fig. 9.

According to possible embodiments, the gripping axis Y is able to be inclined with respect to the annular axis X on a vertical plane by an angle a comprised between about 0° and about 60°.

The orientation of the support 14 can occur during the step of positioning the support 14 itself on the first ring 11 or during a subsequent step.

In possible embodiments not shown, the support 14 can be provided with adjustable orienting means, able to allow a continuous or a click stop adjustment.

According to possible embodiments, the clamping means 19 comprise a pin 25 that connects the upper gripping element 17a and the lower gripping element 17b allowing for a reciprocal tightening.

The pin 25 is made through on the upper gripping element 17a and on the lower gripping element 17b.

The pin 25 has a through hole 26 parallel to the gripping axis Y able to allow the engagement of a respective retractor element 15. The through hole 26 is disposed, for example, in a zone close to one end of the pin 25.

According to one embodiment, the pin 25 can be externally threaded, completely or partly, and be associated with a connection element 27, also threaded, able to define a desired tightening of the gripper 17 on the first ring 11 or on the connection element 21, fig. 6.

According to another embodiment, the pin 25 can be attached in a stable manner to the lower gripping element 17b or to the upper gripping element 17a on one side, and be associated with a lever 28 on the opposite side which allows a pressure tightening of the gripper 17 and the clamping in position of the respective retractor element 15, fig. 7.

According to possible embodiments, the retractor elements 15, known in the field as retraction valves, comprise a stem 29 associated with the support 14 and a respective front gripping portion 16 disposed at a terminal end of the stem 29.

The stem 29 is sliding in the through hole 26 so as to vary the position of the front gripping portion 16 with respect to the edge of the first ring 11 and can be provided with feed notches or holes and with stop means to secure the position reached.

The number of retractor elements 15 useful for the surgical retraction can vary according to the type of intervention. Therefore, the number of supports 14 that can be associated with the first ring 11 of the device 10 is also variable.

The front gripping portion 16 can have different conformations according to the specific application, for example the retraction of a specific organ. For example, the front gripping portion 16 can have the shape of a more or less concave spoon, can comprise gripping teeth or other. The size of the gripping portion 16 can also vary according to the specific application.

According to some embodiments, the connection element 21 can be made in a single piece. The connection element 21 can be single use, made for example with a plastic material, or multiple use made of metal material, for example steel for medical applications.

In possible embodiments, the retractor elements 15 can also be of the single use type, made of a suitable plastic material. In this way, the entire device 10 can be used only once, thus preventing the known problems in the washing and sterilization processes of surgical instruments.

It is clear that modifications and/or additions of parts may be made to the surgical retractor device as described heretofore, without departing from the field and scope of the present invention as defined by the claims.

In the following claims, the sole purpose of the references in brackets is to facilitate reading: they must not be considered as restrictive factors with regard to the field of protection claimed in the specific claims.

Claims

1. Surgical retractor device (10), characterized in that said device (10) comprises:

- a first ring (11) and a second ring (12), connected by a tubular shaped flexible protective membrane (13), which has a first extended condition and a second radially retracted condition, achieved by said first ring (11) winding around itself, around its own axis of annular development (X);

- a plurality of supports (14) releasably coupled to said first ring (11) by means of a respective specialized coupling portion (18, 22), mating in shape with a cross section (A) of said first ring (11), which are able to support a respective retractor element (15) mobile at least linearly, in a radial direction with respect to said first ring (11), wherein the specialized coupling portions (18, 22) are respectively a gripping portion (18) and a coupling portion (22) and each support (14) comprises a gripper (17), having a gripping portion (18) in which there is defined a gripping seating (20), and a connection element (21) having said coupling portion (22), in which there is defined a coupling seating (24) mating in shape with the shape of at least a more external part of the cross section (A) of said first ring (11), and an opposite connection portion (23) mating in shape with said gripping seating (20), said gripper (17) being indirectly coupled to said first ring (11).

2. Device (10) as in claim 1, characterized in that said membrane is able to retract a surgical incision up to a desired diameter, and in that each retractor element (15) is configured to displace and maintain retracted organs and/or anatomical structures covering a specific site of a surgical procedure.

3. Device (10) as in claim 1 or 2, characterized in that the coupling portion (22) has a length (L) sufficient to define a radial extension of the support (14) toward an external part of said first ring (11).

4. Device (10) as in claim 1, 2 or 3, characterized in that said connection element (21) comprises an upper wall (21a) and an opposite lower wall (21b) which together define an aperture for the insertion of the first ring (11) and a bulb (21c) conformed to be housed in said gripping seating (20).

5. Device (10) as in any claim hereinbefore, characterized in that the gripping seating (20) of the gripping portion (18) and/or the coupling seating (24) of the coupling portion (22) have a curved or polygonal profile, mating at least with a part of the profile of the cross section (A) of said first ring (11).

6. Device (10) as in any claim hereinbefore, characterized in that each support (14) develops along a central gripping axis (Y) lying on a plane orthogonal to a plane defined by the axis of annular development (X) of the first ring (11), and in that said support (14) can be oriented so that the gripping axis (Y) is inclined with respect to said plane defined by the axis of annular development (X) of the first ring (11).

7. Device (10) as in any claim hereinbefore, characterized in that it comprises said retractor elements (15).

8. Device (10) as in claim 7, characterized in that said retractor elements (15) are made of a single use plastic material.