WO2017191609A1

WO2017191609A1 - Enhanced suction device for surgical operation

Info

Publication number: WO2017191609A1
Application number: PCT/IB2017/052630
Authority: WO
Inventors: Franco Beoni
Original assignee: Franco Beoni
Priority date: 2016-05-05
Filing date: 2017-05-05
Publication date: 2017-11-09
Also published as: ITUA20163190A1

Abstract

An enhanced suction device (10) for surgical operations, specially suitable for nasal septum surgical operations, comprising a sterilizable and reusable handpiece or grip (12) having an ergonomic shape suitable for being held by a surgeon and connected to a vacuum meter device by way of a hose, a multifunctional cannula (14) defined by an internally hollow and longitudinally developing rigid tubular element, accommodated in and supported by said handpiece (12) and projecting with respect thereto, the device also comprising manually operatable means for adjusting the length of the externally projecting portion and the orientation of the cannula (14) with respect to the handpiece or grip (12).

Description

ENHANCED SUCTION DEVICE FOR SURGICAL OPERATION

The present invention refers to an enhanced suction device for surgical operations.

More specifically, the present invention refers to a suction device, especially suitable for nasal septum surgery and typically referred to with the term of "aspirator", particularly but not exclusively suitable for performing septoplasty operations.

As is known, in surgery and, more specifically, in the otolaryngologic surgery sector, i.e. in that branch of surgery which deals with the pathologies of ear, nose, pharynx, larynx, or the oral cavity and the other structures related to head and neck, by "aspirator" we commonly mean a device used by surgeons and connected to a pipe which drains the liquids from the operative field into a siphon of the aspirator/vacuum gauge, i.e. the machine used in the operating room to produce vacuum for sucking liquids .

So, in the present disclosure, by "aspirator" we mean such device held by a surgeon and used in septoplasty operations .

Suction devices are typically classified into two types as follows :

- reusable devices;

- sterilized, disposable devices.

"Reusable" aspirators are sterilizable and are made from a metallic material and, typically, by surgical grade stainless steel. However, such type of aspirators features a number of substantial drawbacks bound to the fact that for such aspirators, which comprise a long and thin cannula, the washing and sterilization operations might be insufficient to remove all particles of blood and exudate contained inside said cannula.

The second known type of aspirators solves the drawbacks of the reusable aspirators. As a matter of fact, in the specific case of nasal surgery (septoplasty) and/or of other types of surgery (for instance, neurosurgery) sterilized, disposable aspirators are made from a polymeric material and metal and, more specifically, they comprise cannulas made from a metallic material, account being take of the small diameter thereof and of the shape of the terminal tip which shall be shaped as a function of the specific surgical requirements (for instance, having a "beveled" tip for mucosa detaching purposes in the septoplasty surgery or a rounded and atraumatic tip in the case of neurosurgery) . This known type of aspirators comprises two elements rigidly integrated with each other, namely a handpiece or grip made from a polymeric material, and a cannula made from a metallic material.

However, this type of aspirators also features a number of major drawbacks bound to the fact that the complete suction device shall be thrown away and disposed of after being used, in that it cannot be sterilized; this entails a number of economic disadvantages, because not only it is necessary to have a remarkable number of said aspirators stored to be able to perform surgical operations, but it is also necessary to have different aspirators at disposal as a function of the different types of terminal tips.

A further drawback of the traditional devices consists in that they need cannulas having a different length for every gauge or diameter of the cannula itself, which implies increased costs and the need for having a big quantity of said cannulas stored.

Other known solutions, for instance those disclosed in DE 202007014482, try to solve the problems described here above by way of a handpiece and a cannula to be managed separately, the cannula being lockable with respect to the handpiece in order to use a disposable cannula.

Another known solution is disclosed in US 5.827.218 or in US 2003/0088235 and comprises a handpiece to an end of which there is fixed, via a threaded connection or another known type of connection, a cannula having a predetermined length internally to which there is inserted a tubular pipe projecting with respect to the cannula fixed to the handpiece .

Further solutions wherein the handpiece and the cannula consist of separate and separatable elements are disclosed in EP 1115341 and in US 5.911.700.

However, such known solutions, even though allowing to overcome the drawbacks of the reusable devices and of the disposable, sterilized ones as described above, feature a number of major drawbacks bound to the fact that the cannula has a defined length and, consequently, said cannula shall be replaced with cannulas of different lengths as a function of the type of surgical operation the surgeon shall perform; such situation entails the need for having multiple types of cannulas with different lengths at disposal and, consequently, it entails the need for having a permanently equipped warehouse, with the evident costs resulting therefrom.

A further drawback bound to such solutions consists in that a surgeon shall interrupt the steps of a surgical operation to replace the cannulas, which evidently results in extending the time of the surgical operation and in increasing the possibility of errors.

An object of the present invention is to obviate the above described drawbacks.

More specifically, an object of the present invention is to provide an enhanced device for surgical operations, in particular those of the nasal septum, that is sterilizable and reusable.

A further object of the present invention is to provide a device for surgery and, in particular, for nasal surgery that allows to reduce the number of units to be warehoused and, consequently, allows to reduce warehousing costs.

A further object of the enhanced device according to the invention consists in that it allows a fast, quick, as well as easy adaption of the length of the cannula as a function of the specific requirements; this implies a related advantage associated with the fact that the surgeon saves time and reduces possible inattentions due to the continual need for a surgical nurse to replace the aspirator.

A further object of the present invention is to put at users' disposal an enhanced device for surgery, especially the nasal one, suitable for providing high strength and reliability over time and also such as to be easily and cost-effectively implemented.

These and others objects are achieved by the invention that presents the characteristics set forth in claim 1.

In accordance with the invention, an enhanced suction device is provided for surgical operations, especially suitable for nasal septum surgery and/or neurosurgery operations, comprising a sterilizable and reusable handpiece or grip having an ergonomic shape suitable for being held by a surgeon and connected to a vacuum gauge device by way of a hose, a multifunctional cannula consisting of an internally hollow and longitudinally developing rigid tubular element, accommodated in and supported by said handpiece and projecting with respect thereto, said device comprising manually operatable means to adjust the length of the externally projecting portion and the orientation of the cannula with respect to the handpiece or grip .

Advantageous embodiments of the invention are apparent from the dependent claims.

The construction and functional characteristics of the enhanced suction device for surgical operations according to the present invention will be more understandable from the following detailed description, wherein reference will be made to the attached drawings which illustrate a preferred, but not limitative embodiment thereof, and wherein :

figure 1 schematically shows a partially cross-sectional and side view according to a longitudinal direction of development of the enhanced suction device for surgery of the present invention;

figure 2 shows a schematic bottom view of the handpiece or grip of the surgical device of the invention;

figure 3 schematically shows a partially cross sectional side view of the device according to the invention wherein adjustment facilities are highlighted as detailed below; figure 4 schematically shows a partially cross sectional side view of the same device according to a different configuration of use;

figures 5 and 6 schematically show a front view and an axonometric view respectively of a component part of the device of the invention according to an alternative embodiment .

With reference to the mentioned figures, the enhanced suction device for surgery of the present invention, identified by the reference numeral 10 as a whole in figures 1, 3, and 4, comprises a handpiece or grip 12 made from a plastic material (typically a polymeric material) suitable for being held by a surgeon to perform the functions described below, with a minimum effort and a high precision, said handpiece being suitable for accommodating and supporting a longitudinally developing cannula 14 made from a metallic material (preferably surgical grade stainless steel) .

The handpiece or grip 12 comprises a central body 16 elongated in the longitudinal direction and from two opposed ends 16' and 16' ' of which a first tubular appendage 18 and a secondo tubular appendage 19, coaxial to each other, develop in two opposed directions respectively. The first tubular appendage 18 develops with a constant diameter, whereas the second tubular appendage 19 develops according to a conical external profile 19' which is tapered (and possibly serrated) starting from the end 16' ' of the central body 16 (as moving away therefrom) to make it possible a firm connection of a hose (not shown in the figures) connected to a vacuum gauge device (not shown either) .

Said first tubular appendage 18 makes up the head of the handpiece or grip 12, whereas the second appendage 19, which the hose of the vacuum hose is secured to, makes up the trail portion.

The handpiece or grip 12 comprises a channel or through duct 20, which crosses the first appendage 18, the central body 16, and the second appendage 19 to receive the cannula 14 and performing the function that will be more clearly apparent in the rest of this description.

In one embodiment, alternative to the preferred one illustrated by the figures, the duct of the handpiece or grip features a fixed diameter and comprises interchangeable bushes or sleeves inserted at the two appendages 18 and 19 and performing the function of making up duct reduction elements thus making it possible the use of one and the same handpiece or grip for cannulas of different diameters.

The central body 16 of the handpiece or grip 12 comprises a shaped appendage 22 which develops starting from a lower base or front 23 of the central body 16 to make up a wing the function of which is to define a grip element for a hand of the surgeon who holds the surgical device; more specifically, said shaped appendage 22 is shaped in such a way as to be held between the thumb and the middle finger, indifferently, of the surgeon's right or left hand.

On an upper base or front 25 of the central body, opposite to the lower base or front 16, there is an opening 26 cut, as with all conventional suction devices, suitable for enabling the surgeon to adjust the suction pressure of the device; as a matter of fact, the surgeon can move his/her forefinger on such opening 26 to vary the open portion and consequently to vary the suction pressure.

The central body 16 of the handpiece or grip 12 preferably includes in correspondence with either side surface a threaded hole (not shown) suitable for making up a seat for a clamping screw 28 which engages the cannula 14 and performing the function described below; said clamping screw 28 possibly comprises a knurled ring nut 28' to make it easier for the surgeon to move the screw and, in this way, to adjust the length of that portion of the cannula 14 which projects from the handpiece or grip 12 and to lock it in such position as a function of the specific requirements bound to the surgical operation being made.

In accordance with an alternative embodiment, that portion of the cannula 14 which projects from the handpiece or grip 12 can be adjusted in length and locked in a position by way of a lever or a spindle clamping device (similar to that in use in drills to clamp the drill tip) or even by way of an eccentric lever mechanism.

The handpiece or grip 12, while retaining the essential and characteristic elements described above, features such an ergonomic shape as to be held in an optimum way by the surgeon with a comfortable and safe grip and also such as to provide high accuracy in using and handling the device. As described above, the cannula 14 is comprised of a rigid tubular element, developing in a rectilinear longitudinal direction, internally hollow and provided with tips of different shapes at the two opposed ends.

A first end of the cannula 14 (the left end in figures 1 and 3) has a first tip 30 featuring a slight curvature or tilt a with respect to the axis of the cannula itself (according to the preferred embodiment, such tilt corresponds to that of the conventional surgical instruments used to detach the nasal septum (for instance, the Joseph elevator) , however it is understood that such tilt might also have different values as a function of the specific requirements), a squeeze (or flat) surface defining a "spatula" shape, and a hole 32 which connects the outside to the hollow inside part of the cannula 14 to make it possible for the elements sucked during the surgical operation to pass through said hollow inside part toward the vacuum gauge.

A second end of said cannula 14, opposed to the first end, includes a second "beveled" (or slice-of-salami shaped) second tip 34, i.e. a tip shaped according to an inclined plane with respect to the axis of the cannula 14.

In accordance with an alternative embodiment, the cannula 14 possibly has a tip for the second end having a "spatula" shape different from the spatula shape according to the preferred embodiment described here above.

More specifically, with reference to figures 5 and 6, the cannula 14, which features a substantially circular cross- section and a cylindric longitudinal development progressively squeezes upon moving toward the end (opposed to the end comprising the beveled tip) to make up a substantially elliptical cross-section in the direction of a tip 30' which comprises a shaped appendage 45 which develops starting from the end of the tip 30' to define a first portion 46 whose width is narrower than that of the tip 30', the opposed side edges 46' being curvilinear, and a second, "spatula" shaped portion 47 which develops starting from the first portion 46, along a length of the sectional profile of the cannula, having a width greater than that of the first portion 46, in correspondence with the side edges 46' there are formed opposed openings 48 suitable for connecting the outside to the hollow inside part of the cannula. The two shaped portions as described above make it possible to use one and the same cannula for different steps of a surgical operation; therefore, such cannula 14 has the characteristics of a multifunctional instrument.

Here follows a description of the mode of use of the suction device of the present invention as described in details above with reference to its construction characteristics .

The surgeon inserts the cannula 14 into the through duct 20 of the handpiece or grip 12, either tip 30 or 32 projecting with respect to the head portion of said handpiece (such selection being made as a function of the specific operations the surgeon plans to make) and adjusts the length of that portion of the cannula which projects with respect to the head portion of the handpiece or grip 12, by making said cannula 14 axially slide with respect to the through duct 20 of said handpiece, as schematically shown by the arrows X and by the portions of the cannula represented in dotted lines in figure 3. The surgeon can also rotate the cannula with respect to its owns axis so as to adjust the orientation of the first tip 30 or of the second tip 32 as a function of the specific requirements (as indicated by the arrow Y in figure 3) .

Having adjusted the length and the orientation of the cannula as a function of the specific function to be performed, the surgeon acts onto the clamping screw 28 to lock the cannula and prevent any displacement of the cannula whenever it is subject to thrust or tensile forces in the surgical field.

The surgeon can also slacken the clamping screw 28 to take off the cannula 14 and vary the type of tip to be used; for instance, as schematically shown in figure 4, it is possible to invert the cannula 14 and arrange the beveled tip 34 at the head of the handpiece 12. Likewise, in the case of the alternative embodiment described above wherein one and the same handpiece or grip can accommodate cannulas of different diameters, the surgeon can replace the cannula 14 and insert in the handpiece a cannula having a different diameter .

Considering, for explanatory purposes, the case of a nasal surgical operation and, more specifically, a septoplasty operation, the surgeon performs first of all a nasal mucosa detaching operation by using the "beveled" tip 34 (such tip being sharp helps the surgeon in finding the perichondral and subperiostal detaching plane and, consequently, he/she shall set the device with the tip 34 of the cannula 14 that projects from the head part of the handpiece or grip 12. In this initial step, the surgeon shall detach the mucosa of the nasal septum in the part close to nostrils, hence it is comfortable to use a short instrument (as a matter of fact, a short instrument makes it possible an accurate and little difficult control of the tip of the instrument as compared to the tip of a long instrument), therefore he/she withdraws the cannula by a little, approximately one/two centimeters then, as the detachment operation goes on, gradually increases the projection of the cannula from the handpiece .

In order to detach the left part of the mucosa of the nasal septum, the surgeon rotates the cannula in such a way that the flat part is parallel to the nasal septum whereas to detach the opposed part of the mucosa, he/she will rotate the cannula by 180° and, also, to detach the floor of the nasal fossae and the spine of the maxillary bone, he/she will rotate the cannula by 90°.

Having terminated the above described steps, the surgeon, in order to go on and detach the mucosa of the septum in the direction of the inside of the nose, shall replace the "beveled" tip, because it is sharp-edged and might potentially perforate the mucosa; such detachment shall be performed by using a non-sharp spatula shaped tip 30 of the cannula 14. To do this, the surgeon shall slacken the bond existing between the clamping screw 28 and the cannula itself, completely take-off said cannula 14, and re^¬ position it, the tip 30 being set in correspondence with the head portion of the handpiece or grip 12, and adjust the portion of the cannula 14 projecting with respect to the first appendage 18 or head portion of the handpiece 12, as a function of the specific handling requirements.

In performing the above-mentioned steps of the operation, the surgeon has the possibility of adjusting the projecting length of the cannula with respect to the handpiece or, as described before, rotating it in order to better move the surgical device as a function of the surgical operation requirements (for instance, a shorter length whenever the surgeon operates in an area close to his/her own hand and an adjustment of said length as the operation goes on) . As it can be inferred from the foregoing, the advantages achieved by the device according to the invention are apparent .

The enhanced suction device for surgical operations of the present invention offers the advantage of being sterilizable and reusable in that it allows to replace the disposable cannulas and to sterilize the handpiece or grip which, conversely, can be completely sterilized; this allows to reduce the number of units to be warehoused and simultaneously results in reduced warehousing costs.

A further and surprising advantage of the device according to the invention consists in that the surgeon can, in any moment during the surgical operation, adjust the projecting length (with respect to the head portion of the handpiece) of the cannula; as a matter of fact, should the surgeon have to operate in a zone close to his/her own hand, a short cannula makes it possible to operate in an easier and more accurate way and, also, the surgeon can act onto the clamping screw of the handpiece to extend the projecting portion of the cannula as he/she goes deeper in the surgical field.

Further advantageous is the fact that the surgical device according to the invention includes two tips having different shapes and, consequently, during an operation the surgeon has the possibility of withdrawing the cannula and using either of the two different tips as a function of the specific requirements and, also, of rotating said cannula in such a way, for instance, as to have the flat part of the spatula shaped tip always parallel to the nasal septum. Even though the invention has been described here above with a special reference to an embodiment thereof which has been provided for explanatory not limitative purposes only, numerous modifications and variants will be apparent to a person skilled in the art in the light of the disclosure given above. Therefore, the present invention is to be construed to embrace all modifications and variants that fall in the scope of the following claims.

Claims

1. An enhanced suction device (10) for surgical operations, specially suitable for nasal septum surgery and/or neurosurgery operations, comprising a sterilizable and reusable handpiece or grip (12) having an ergonomic shape suitable for being held by a surgeon and connected to a vacuum gauge device by way of a hose, a multifunctional cannula (14) consisting of an internally hollow and longitudinally developing rigid tubular element, accommodated in and supported by said handpiece (12) and projecting with respect thereto, characterized in that it comprises manually operatable means for adjusting the length of the externally projecting portion, the orientation with respect to the handpiece or grip (12), and the type of tip of the cannula (14) which comprises a first end provided with a first tip (30, 30') and a second end provided with a second tip (34) different from said first tip .

2. A device according to claim 1, characterized in that the manually operatable means used to adjust the length of the externally projecting portion and the orientation of the cannula (14) with respect to the handpiece or grip (12) comprise a clamping screw (28) inserted into the handpiece or grip (12) and suitable for engaging the cannula (14) .

3. A device according to claim 1, characterized in that said manually operatable means comprise a lever secured to the handpiece.

4. A device according to claim 1, characterized in that the manually operatable means comprise a clamping spindle or a ring nut integrated in the handpiece or grip (12) .

5. A device according to claim 1, characterized in that the manually operatable means comprise an eccentric lever mechanism .

6. A device according to any of the previous claims, characterized in that the cannula (14) comprises a first end provided with a first tip (30) having a tilt (a) with respect to the axis of the cannula and a squeezed or flat surface to define a "spatula" shape, said first tip (30) also being provided with a hole (32) which connects the outside to the hollow inside part of said cannula (14), whereas the second end of said cannula (14) is provided with a second "beveled" tip (34) .

7. A device according to any of the previous claims, characterized in that the cannula (14) features, on the part opposed to that of the second "beveled" tip, a substantially circular cross section and a cylindrical longitudinal development, which progressively squeezes in the direction of the free end, to make up a substantially elliptical cross section in the direction of a tip (30') which comprises a shaped appendage (45) which develops starting from the end of said tip (30') to define a first portion (46) having a width narrower than that of the tip (30'), the opposed side edges (46') being substantially curvilinear, and a second "spatula" shaped portion (47) which develops starting from the first portion (46) , along a length of the sectional profile of the cannula, having a width greater than that of the first portion (46), in correspondence with the side edges (46') opposed openings (48) being formed, suitable for connecting the outside to the hollow inside part of the cannula.

8. A device according to any of the previous claims, characterized in that the handpiece or grip (12) comprises a central body (16) elongated in the longitudinal direction and from two opposed ends (16', 16' ') of which a first tubular appendage (18) and a second tubular appendage (19), coaxial to each other, develop in opposed directions respectively, to define a head portion from which the cannula (14) externally projects and a tail portion suitable for being connected to the vacuum gauge respectively, said handpiece or grip (12) comprising a channel or through duct (20) which crosses said first appendage (18), said central body (16) and said second appendage (19), and suitable for accommodating the cannula (14) .

9. A device according to claim 7, characterized in that the central body (16) of the handpiece or grip (12) comprises a shaped appendage (22) which develops starting from a lower base or front (23) of said central body (16) to form a wing the function of which is to define a grip element for the surgeon's hand.

10. A device according to any of the previous claims, characterized in that the handpiece or grip (12) is made from a sterilizable and reusable polymeric material and in that the cannula (14) is made from a metallic material such as surgical grade stainless steel.

11. A method for using the suction device according to one or several of claims 1 thru 8, characterized in that it comprises the following steps:

- inserting the cannula (14) into the through duct (20) of the handpiece or grip (12), either tip (30, 30',

34) projecting with respect to the head portion of said handpiece, and adjusting that length of the portion of the cannula (14) which projects with respect to the head portion or first appendage (18) of the handpiece or grip (12) by making said cannula (14) slide internally to the through duct (20) of the handpiece (12) ;

- adjusting the orientation of the tip (30, 30', 34) of the projecting cannula (14);

- locking the position and orientation of said cannula (14) by using the manually operatable means of said handpiece or grip;

- if necessary, inverting the tip (30, 30', 34) of the cannula (14) or replacing the type of cannula (14) by acting onto the manually operatable means of the handpiece or grip (12) in order to release the cannula (14) from said handpiece .