DESCRIPTION

FIELD OF THE INVENTION

The present invention relates to a retraction kit suitable for being used for traction and retraction of breast tissues during breast surgery performed through small skin incisions, called “M.A.R.B.S. “(Multifunctional Articulated Retraction in Breast Surgery) system. The invention consists of two articulated retractors, each equipped with a fixed blade and a group of articulated blades.

BACKGROUND OF THE INVENTION

The surgical treatment of malignant breast tumours can include the removal of a part of the glad with possible plastic remodelling (conservative intervention) or of the whole thereof (mastectomy) with the various reconstruction proposals (demolition and reconstructive intervention). Specifically, when mastectomy is indicated, the most popular option is the “conservative mastectomy”, which preserves the skin envelope and the nipple areola complex, providing instead the radical removal of the gland contained under these structures, through a small skin incision. The advantage of this technique in comparison to radical mastectomy (with the removal of large skin flaps and the nipple areola complex) is mainly represented by the option of simultaneously carrying out a complete reconstruction restoring the excised volume, filling the preserved envelope. For this purpose, anatomical expanders, silicone implants or autologous tissues are used, which ensure immediate and high quality breast reconstruction.

In the context of this surgical technique, a correct dissection of the skin flap that is preserved is the milestone of conservative mastectomy; the creation of a healthy and uniform thickness of skin having an adequate vascular supply allows to ensure vitality and thence survival of the skin flap, the success of reconstruction and a better aesthetic result. Adequate instrumentation is fundamentally important to achieve this goal during surgery: the appropriate retraction of tissues and the application of uniform tension/traction are essential elements to ensure the success of this procedure. On the other hand, the need to complete the procedure via a small skin incision (3-6 cm) makes this technique demanding and highly challenging, especially in large and ptotis breasts.

Usually, given the tiny size of the skin access, it is possible to insert a single retractor that can lift only a limited portion of the skin flap, while the surgeon uses his fingers to lower and pull the mammary gland and uses the electrosurgical unit to perform dissection of breast tissue from the skin flap. At the same time, it is essential to cleanse the deep cavity that is expanding during the dissection from the fumes produced by the cauterization of the electrosurgical unit, which obscure the operator’s field of vision: therefore, an assistant provides to insert a suction cannula through the same skin breach during the resection period. This determines a further crowding of the operating site, makes the operation itself and the visibility by the operator difficult and arises the need for support by additional assistants to manipulate each device. Another critical issue that is determined during the procedure is the creation of adequate lighting inside the surgical cavity, an essential element to allow the resection precision, to save blood vessels of the skin flap and to ensure a complete and radical removal of the gland. Surely, ambient light is not sufficient for this purpose and usually even a collimated and well-directed external artificial light can only partially filter between the edges of the incision, resulting overall inadequate to ensure proper lighting.

SUMMARY OF THE INVENTION

The technical problem posed and solved by the present invention is to provide a breast tissue retraction kit suitable for surgical use, which allows to overcome the problems above mentioned with reference to the known art.

This is achieved by means of an articulated retractor, defined in the independent claim 1 , as well as by a retraction kit, as defined in the independent claim 12 which comprises the aforementioned articulated retractor, together with a further retractor device. Secondary characteristics and specific embodiments of the objects of the present invention are defined within the dependent claims.

In the context of the present invention, the expression “retractor device”, or more simply “retractor”, means a surgical instrument which allows the separation of the edges of an incision or wound affecting a patient’s body area. In addition, the instrument can be used to hold or move organs and tissues underlying the incision or wound, in order to facilitate the vision of other body parts or facilitate surgical operations. Again, the term “retractor” can be further understood as a surgical device having a retractor function, that is a surgical instrument apt to retract and spread soft tissues during operations, as well as an “expander”, that is a surgical instrument that is apt to push tissues.

In the context of the present invention, the expression “operating site” means the portion of the body area within the incision or wound, in which the surgical operation is performed.

The first surgical retractor (upper retractor) according to the present invention comprises a group of movable or articulated blades, arranged according to a fan-shaped configuration with respect to a fixed blade. The articulated blades are moved by activating an actuation mechanism, which according to a first aspect of the invention is configured to allow not only the control, although also the adjustment of movement of the blades themselves.

According to a second aspect of the invention, the articulated blades are movable according to an approaching/moving away motion from the fixed blade.

According to a third aspect of the invention, the retractor comprises a lighting module, configured to selectively emit a light beam at the blades, to illuminate the operating site.

According to a fourth aspect of the invention, the retractor comprises a camera for the acquisition of images of the operating site, such that it is possible to monitor in real time, and from a privileged viewpoint, the performing surgical process. The integrated camera is configured to transmit images to a monitor, where those can be viewed by the surgeon and other surgical team members, giving deep tissue surgery much more accuracy and easiness.

According to a further aspect of the invention, the device comprises suction means for gas and/or liquids for clearing the visual field in the operating site.

It is thence needed a surgical instrument which combines the functions of retraction, wide expansion, full illumination, full suction, ergonomic handle for a comfortable and firm grip, safety on the body tissues, possibility of video assistance, while remaining light and easy to handle.

The second surgical device (lower retractor) according to the invention is a retractor provided with five blades, of which one is fixed and four are movable, and a control mechanism to adjust its progressive opening.

Thanks to their particular conformation, the aforementioned retractors can be inserted into very deep and narrow fields, ensuring good grip, good traction of the tissues even on large surfaces, good control of the anatomical planes and good vision. The kit is comprehensive of the first and second retractors above mentioned.

The use of the kit allows to apply and maintain a constant retraction tension on the tissue flaps and allows maximum visibility of the operating site, by means of the association between the light source and the gas suction system, while remaining light and easy to handle. This non-traumatic surgical kit can be easily inserted into the patient even through a small incision, and can be progressively configured to apply a progressive and homogeneous traction, on progressively increasing surfaces, in order to expose a wide surgical field allowing maximum visibility to the operator.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will be made to the attached Figures, in which:

- Figure 1 shows a perspective view of the first retractor device according to a preferred embodiment of the present invention;

- Figure 2 shows a front view of the device of Figure 1 ;

- Figure 3 shows a bottom view of the device of Figure 1 ;

- Figure 4 shows a perspective view of the second retractor device according to the present invention; and

- Figure 5 shows a side view of the second device of Figure 4.

DETAILED DESCRIPTION

With reference to Figure 1 , a preferred embodiment of a first retractor device according to the present invention is overall denoted by the reference number 1.

The retractor 1 is suitable for use in breast surgery operations to perform a retraction of tissues such as the walls of an incision, and to allow the correct visualization of an operating site inside the incision itself.

The retractor 1 substantially presents itself as a device comprising a proximal portion 11 and a distal portion 12, connected at one of its own terminal ends. The proximal portion 11 and the distal portion 12 can be distinguished by observing a different direction of spatial development.

Indeed, the proximal portion 11 , configured in the first place to allow handling by a user, bears a first longitudinal development axis A. The distal portion 12, which corresponds to the endoscopic or operative part of the device 1 , includes a main body 100, which has a second longitudinal development axis B sloped with respect to axis A, preferably to provide an angular opening comprised between about 60° and 120° with respect to axis A, even more preferably equal to about 90°. Therefore, the proximal portion 11 and the distal portion 12 of the device 1 can have a mutually orthogonal development, giving the device 1 an overall L-shaped conformation, in which preferably the arms of the L refer to one of the aforementioned portions 11 , 12 and have substantially the same length.

The proximal portion 11 can have an overall elongated configuration, even more preferably substantially cylindrical, and bear at least one shaped portion 111 intended to be gripped by a user, configured in an ergonomic manner. The free terminal end of the proximal portion 11 is flared, to allow an easier grip, and can have protrusions 105 (having a main direction of development orthogonal or parallel with respect to the external surface of the proximal portion 11 ) to facilitate a comfortable and firm grip by the user.

The distal portion 12 bears two groups of blades, respectively a first group 13 which comprises one or more fixed blades 102 and a second group 14 which bears a plurality of movable blades 103. The movable blades 103 are configured to be able to selectively vary their positioning with respect to the main body 100 and/or the fixed blades 102.

Preferably, the retractor 1 is coated with insulating material on the shaped portion 111 of handling, and/or on the fixed blade(s) 102.

As shown in Figure 1 , the fixed blades 102 can be comprised in, or form an integral part of, the main body 100. Preferably, the fixed blades 102 have the same longitudinal development direction B as the main body 100. In particular, as shown in the preferred embodiment of Figures 1 and 2, the longitudinal development direction B can coincide with a symmetry axis of the distal portion 12. Furthermore, preferably, there is a single fixed blade 102, which in this case can substantially coincide at least with the free terminal end of the main body 100.

The movable blades 103 are preferably two or more, even more preferably the device 1 comprises four movable blades 103 arranged in opposite pairs with respect to the main body 100, which is therefore interposed between the movable blades 103. Each movable blade 103 bears a third longitudinal development axis C, which has a predetermined slope with respect to the longitudinal development axis A.

The device 1 comprises at least one lighting source 106 arranged at the first and/or second group of blades 13, 14. In particular, it can be provided that one or more of the fixed blades 102 or mobile blades 103 comprise a lighting source 106, arranged preferably at an operative surface of the blade opposite the first portion 11 , as shown in Figure 3. The lighting source 106 is arranged in such a way as to generate a light beam directed towards the terminal end of the blade which is associated therewith, to enlighten the working area of the device 1 .

According to the preferred embodiment shown in Figure 3, the lighting source 106 is connected to a single fixed blade 102 and preferably comprises three light emitting diodes (LEDs). The power source or battery can be located inside the proximal portion 11 , and is in electrical communication with the lighting source 106 to allow its activation. During use, the lighting source 106 is electrically and thermally insulated from the patient’s tissues, preventing any risk of burns from electrocautery to the skin or the breast tissue.

The device 1 further comprises image acquisition means 107, arranged at the first and/or second group of blades 13, 14, comprising at least one camera. The camera itself, or the device 1 , is provided with data transmission means, preferably wireless, to send the images to remote processing devices. Alternatively, a wired connection can be housed inside the blade which the camera is connected thereto and inside the proximal portion 11 .

For example, the images acquired by the camera can be played on a monitor in the operating room where the breast surgery is ongoing, allowing adequate viewing - even remotely - of the patient’s area affected by the surgical operation.

Preferably, a miniaturized camera is connected to a single fixed blade 102 at an operative surface opposite the proximal end 11 , with a shooting angle inclined by 30° with respect to the aforementioned operative surface.

Furthermore, the device 1 can comprise fluid suction means arranged at the first and/or second group of blades 13, 14. The suction means can be particularly configured to draw in gases, such as the fumes generated during surgical operations. In addition, the suction means may further be suitable for drawing up liquids, to allow cleaning of the patient’s area affected by the surgery from body fluids or residues produced during the surgery.

In particular, one or more suction ducts are provided to be housed and to extend within the proximal portion 11 and the distal portion 12, up to the free terminal end of a fixed blade 102. Each suction duct indeed opens into one or more openings at the fixed blade 102 itself, in particular on an operative surface 121 of the fixed blade 102 which faces the proximal portion 11 .

The suction duct can be connected to an external suction device, suitable for forcibly conveying the fluids present in the region of the patient’s tissues adjacent to the retractor 1 during use. It is particularly advantageous to use the fluid suction means 206 to draw the cauterization smoke from the mammary cavity, increasing the visibility of the operating site.

According to a preferred embodiment, the movable blades 103 are suitable for assuming a first deployed configuration, which corresponds to a configuration of maximum encumbrance of device 1 , and a second retracted configuration, which corresponds to a configuration of minimum encumbrance of the device. 1.

In particular, with reference to Figures 1 to 3, the movable blades 103 are arranged according to a fan-shaped configuration with respect to the first blade group 13 or to the main body 1 , in which a “closed fan” configuration corresponds to the minimum size of the device, while the “open fan” corresponds to the maximum size of the device.

Further with respect to the first group of blades 13 or the main body 100, the configuration of maximum encumbrance can be understood as a configuration of maximum divergence of the movable blades 103 with respect to the second longitudinal development axis B.

In order to activate and control the movement of movable blades 103, device 1 comprises an actuation module operatively connected to the second group of blades 14. In particular, the actuation module is configured to allow the adjustment of the divarication of movable blades 103 with respect to the second longitudinal development axis B of the main body 100.

According to a preferred embodiment of the invention, the movable blades 103 are apt to selectively rotate around an axis of rotation R, which can be substantially orthogonal with respect to the second longitudinal development axis B. Even more preferably, the axis of rotation R is parallel to, or coinciding with, the first longitudinal development axis A of the proximal portion. According to this preferred variant, the movable blades 103 are pivoted with respect to the main body 100.

The actuation module can comprise a mechanical actuator 104 that can be manually rotated by the operator around the axis of rotation R or the first longitudinal development axis A, configured in such a way that a rotation of the actuator 104 (for example a complete revolution around the axis of R) corresponds to a rotation of the movable blades 103. In other words, the rotation of the blades 103 is directly proportional to the rotation of the actuator. Preferably, the rotation angle of the actuator is greater than the corresponding rotation angle described by the blades 103, such that the operator is able to precisely adjust the movement of the movable blades. The mechanical actuator may have a component having an annular configuration intended for manipulation by the operator. This annular component, or more simply ring, is arranged concentrically with respect to the proximal portion 11 , preferably at the free terminal end of the portion 11 , to facilitate the handling by the user. The axis of rotation of the ring preferably coincides with the axis of rotation R of the movable blades 103.

With reference to the preferred embodiment of Figure 1 , in which there are two pairs of movable blades 103 opposite each other with respect to a single fixed blade 102, the rotation of the actuator 104 in accordance with a first direction, for example clockwise, can correspond to the simultaneous approach of the free end of every movable blades 103 to the fixed blade 102, until a complete overlap of the movable blades 103 with the fixed blade 102 is achieved. Conversely, the rotation of the actuator 104 in accordance with a direction opposite to the first, for example anticlockwise, may correspond to the simultaneous removal of the free end of every movable blades 103 from fixed blade 102, until a predetermined position of maximum divergence from fixed blade 102 is achieved.

In particular, the fixed blade 102 can be directly connected to, or form an extension of, a terminal end of the proximal portion 11. The blade 102 preferably has an elongated configuration, with a rectangular geometry section. Furthermore, the fixed blade can have one or more recesses or housings configured to receive the movable blades 103 when the configuration of minimum encumbrance of device 1 is realized.

According to a particularly preferred embodiment of the invention, the device 1 comprises a fixed blade 102 and four movable blades 103, of which a first pair of internal movable blades, corresponding to the two movable blades closest to the fixed blade 102, and a second pair of external movable blades, corresponding to the pair of movable blades furthest from the fixed blade 102, in which the aforementioned first and second pair of movable blades can be activated independently of each other.

This embodiment therefore provides the presence of two distinct actuation mechanisms, one for each pair of movable blades, which can be selectively activated by the user. According to this variant, the device 1 comprises two actuation modules 104, which can be of the type already described, each connected to a respective distinct pair of movable blades, as shown in Figure 2.

Preferably, each of the two blades furthest from the fixed blade 102, i.e. the blades of the second pair, is pivoted with respect to the body of the respective movable blade of the first pair closest thereto. Alternatively, the actuation module can comprise, instead of the rotating ring already described, an electronic mechanism for opening and closing the blades, which is controlled by means of directional buttons, preferably located at the shaped portion 111.

Such buttons transmit the command given by the user to a motor arranged inside the proximal portion itself, kinematically connected to the blades to be actuated.

Thanks to the mobility in opening and closing of the movable blades compared to the fixed blade (or fixed blades), device 1 is therefore configured not only to be able to drive the tissues, although further to push the same, performing the function of both retractor and expander.

Preferably, the device 1 comprises a single central blade, preferably larger than the movable blades.

Even more preferably, the device 1 comprises a single fixed blade 102, and the distal portion 12 of the device 1 is symmetrical with respect to an axis of symmetry B of the aforementioned fixed blade.

According to a preferred embodiment of the device 1 , the movable blades 103 can be arranged in such a way as to be more inclined than the fixed blades 102 with respect to the proximal portion 11. In other words, a first angle a comprised between the third longitudinal development axis C of the movable blades 103 and the first longitudinal development axis A of the proximal portion 11 of device 1 is greater than a second angle b comprised between the second longitudinal development axis B of the fixed blades 102 and the same first longitudinal development axis A.

According to a preferred variant of the device 1 , one or more of the fixed and/or movable blades 102, 103 have a first operative surface 121 facing the proximal portion 11 and bearing a curved profile, in which at least one concavity change is preferably found. Preferably, the operative surface 121 has a convexity facing the proximal portion 11 at a portion of the blades closest to the proximal portion 11 , while it has a concavity facing the proximal portion 11 at the free terminal end of the blade. The concavity can be defined by a direction of development of the blade which defines an angle of approximately 30° with respect to a straight line tangent to the vertex point of the concave profile itself. Preferably, the portion of the concave operative surface can involve more than half, in particular up to more than 1/4 or 1/6, of the operative surface 121.

The particular shape of the blades with convex curvature realizes a particularly advantageous aspect of the invention, since it allows to follow the physiological curvature of the skin envelope of the breast during surgery, exposing a wide field of the operating site to view. Thereby, visibility is maximized and it allows for the creation of a thickness of the healthy and uniform skin with an adequate blood supply, ensuring vitality of the flap on behalf of obtaining excellent clinical and cosmetic results. The effect is indeed less traumatic on the skin flap which has a more physiological shape and allows a better distribution of the traction pressure on the skin flap.

The aforementioned curvature and the aforementioned concavity and convexity trend can be a characteristic not exclusively of the respective operative surface 121 , although of the blades 102, 103 considered in their entirety, as shown in Figure 1 . In other words, the overall conformation of the blades 102, 103 can reproduce the aforementioned curvature and/or variation of concavity.

According to a preferred variant of the device 1 , one or more of the fixed and/or movable blades 102, 103 have at least one rib on the first operative surface 121 to improve adhesion and control of tissues.

The ribs allow to improve the blade’s ability to grasp and hold the patient’s tissues.

A preferred embodiment of a second retractor device according to the present invention is shown in Figures 4 and 5, wherein it is overall denoted by 2.

The second retractor device 2, or lower retractor, has a structure referable to that already described with reference to the first device 1 . Reference will be made hereinafter only to the differences between the first and the second retractor. For those matters not described, what is indicated in the previous description is intended to be valid.

In particular, the second retractor has a proximal portion 221 and a distal portion 201 , bearing at least one fixed blade 231 and a plurality of movable blades 202, preferably four.

The proximal portion 221 and the distal portion 201 preferably have respectively mutually skewed longitudinal development directions, which form an internal angle comprised between 100° and 180°, preferably equal to 160°. Preferably, one or more of the blades have a curvature, in particular with a concavity facing towards the aforementioned internal corner, as shown in Figure 5.

The curved profile of the retractor blades 2 allows the mammary gland to be lowered and raised in a non-traumatic manner. Furthermore, a maximum visibility of the operating site is allowed, avoiding the insertion of the hand into the surgical cavity, which would limit the visual field. Visualization is then further facilitated for effective haemostasis in the pocket and dissection of the periphery of the pocket, a procedure that would be more difficult and dangerous without adequate vision of the operating field.

At least one of the movable blades 202, preferably all the movable blades, has a concave profile, and bears at least one rib on a concave operative surface 222 to improve the ability of the blade to grasp and control the patient’s tissues. Each movable blade 202 is rotatable around a common axis, in such a way as to assume a first deployed configuration, which corresponds to a configuration of maximum encumbrance of device 2, and a second retracted configuration, which corresponds to a configuration of minimum encumbrance of the device 2, in which the movable blades are overlapped with respect to the fixed blade. For this purpose, the device 2 comprises an actuation module 203, which can bear a ring rotatable around the same axis of rotation of the movable blades 202, according to what already described with reference to the retractor 1 . The actuation module 203 can be placed at the proximal portion 221.

In particular, a clockwise movement of the ring drives the blades 202 into a configuration of minimum encumbrance, while a counter clockwise movement unfolds the blades 202. The amplitude of the movement described by the blades 202 is directly proportional to the magnitude of the screwing the ring. As for the retractor 1 , also a preferred embodiment of the retractor 2 can provide the blades 202 to be arranged as a first pair of internal movable blades and a second pair of external movable blades, in which the aforementioned first and second pair of movable blades can be actuated independently of each other.

This embodiment therefore provides the presence of two distinct actuation mechanisms, one for each pair of movable blades, which can be selectively activated by the user. According to this variant, the device 2 comprises two actuation modules, which can be of the type already described, each connected to a respective distinct pair of movable blades, as shown in Figure 2.

Preferably, each of the two blades of the outer pair is pivoted with respect to the body of the movable blade of the inner pair closest thereto.

Alternatively, the actuation module can comprise, instead of the rotating ring already described, an electronic mechanism for opening and closing the blades, which is controlled by directional buttons. Such buttons are preferably located at a shaped portion 204 of the proximal portion 221 .

The shaped portion 204 is ergonomically shaped, and has the free end being flared to allow an easier grip by the operator. The shaped portion 204 can have protrusions 205 (with the main development direction parallel or orthogonal with respect to the external surface of the proximal portion) to facilitate a comfortable and firm grip by the user.

Eventually, the device 2 can further comprise suction means for fluid in accordance with what already described, denoted by the reference number 206 in Figure 5.

The object of the present invention has been hitherto described with reference to its embodiments. It is to be understood that other embodiments may exist which pertain to the same inventive core, each falling within the protection scope of the claims set forth below.