Device for treatments of endoscopic resection/removal of tissues

A device (1) for treatments of endoscopic resection/removal of tissues, includes: a handpiece apt to be held by an user; an external tubular element (3) having a proximal end, a distal end and a cutting aperture disposed at the distal end; an internal tubular element (4) apt to be pivotally housed in the external tubular element (3) and having a proximal end, a distal end and a cutting tip at its distal end. The device also includes guide elements (5) for rotating and/or oscillating the internal tubular element (4) with respect to the external tubular element (3). The guide elements (5) include an electric motor (19) and electric feeding element for the electric motor (19) and are contained completely inside the handpiece (2).

RELATED APPLICATIONS

This application is a US national phase application of international application number PCT/IB2010/001411, filed 14 Jun. 2010, which designates the US and claims priority to Swiss (CH) application 00940/09 filed 16 Jun. 2009, the contents of each of which are hereby incorporated by reference as if set forth in their entireties.

FIELD OF THE INVENTION

The present invention relates to a device for treatments of endoscopic resection/removal of tissues. In particular, the invention relates to an endoscopic device for resection treatments of soft tissue or osseous tissue (with relative removal of the fragments produced by such an action).

BACKGROUND OF THE INVENTION

As an alternative to the traditional surgery, which requires a relatively wide incision to access to the surgical site inside the human body, the endoscopic procedures utilize natural accesses or as an alternative the creation of small portals (minimal tissular incisions); therefore often reference is made to the endoscopic surgery with the term of mini-invasive surgery. The two main advantages of the endoscopic surgery are the more rapid healing of the tissues after the surgical operation and the lesser exposition of internal tissues to the risk of an infection. The technological developments in this surgical field, also defined “closed”, have led to the realization of many minimally invasive instruments, as the access to the surgical site is made through one or more portals. Such instruments must be sufficiently elongated and smooth to permit the entrance and the use with a minimum trauma for the surrounding tissues. A portion of the instrument, usually indicated as “distal portion”, is so conceived in order to have access to the surgical site; the opposite portion, usually indicated as “proximal portion”, remains at the outside of the body of the patient. The distal portion of the instrument is typically provided for treating the tissue with which it comes in contact, its shape and dimensions being therefore properly studied in function of the particular surgical operation to which it is destined.

The proximal portion is instead provided with a mechanism to control from the outside of the body of the patient the above function. The motorized endoscopic surgical instruments, used in the “closed” surgery, often identified as endoscopic “shavers”, are typically made by a pair of coaxial tubular concentrically disposed elements: an external element ending distally with an aperture or “cutting window” and a rotary internal element having a sharp surface at the cutting window. The rotary action of the internal tubular element produces by abrasion the removal or the finishing of the tissue, this process being defined as “resection”.

As in each surgical action, also in the endoscopic surgery the presence of two well distinct fields is provided: the sterile field, the one in close contact with the patient, whereby the surgeon will perform his operation, and the one definitely separated from the patient and from any object coming in contact with it. Only suitably treated personnel and instruments can access to the sterile field (sterilization processes for the instruments, washing pre-operatory processes and adoption of protective aids for the personnel, as gloves and coats); all that can not enter in contact with the sterile field must rigorously remain outside it.

US2007/0010823 describes a “shaver” for arthroscopic operations and a system for performing the suction and the irrigation during a medical procedure with the above “shaver”.

U.S. Pat. No. 5,669,921 describes a cutting device comprising:an elongated external having a proximal end, a distal end and at said proximal end a bushing to permit the attachment of the external tube to an electrically fed sleeve; andan elongated internal tube apt to be received in said external tube, having a proximal end, a distal end, an internal aperture at said distal end, a cutting tip and a bushing disposed at the proximal end, the bushing permitting the connection of the internal tube to guide means for the cutting device.

The Applicant has noted that in the endoscopic “shavers” actually existing and/or in those described above the internal tubular element is brought in rotation and controlled by a handpiece having internally a small electric motor: the actuation and control are made either by pushbuttons positioned on the sleeve itself or by pushbuttons positioned on a pedal board. In both cases the power and the control signals arrive at the sleeve through a wire connected with an external bracket. This “bracket” is usually disposed on a trolley sufficiently distant from the operation field in order not to contaminate the sterile field. The handpiece (which comes in contact with the sterile field) undergoes a sterilization treatment before each surgical operation; the bracket having to remain out of each contact with the sterile zone, is housed out of the aforesaid field; in the actually existing systems, a connection wire is provided between handpiece and “bracket”. Such connection wire before each use is treated in order to render it completely sterile and at the preparation of the surgical operation it is assembled from one side with the (sterile) handpiece and from the other side with the (non sterile) bracket. In the actually existing “shavers” the handpiece is made of a metallic material, so it has a not negligeable weight, and the connection wire has a weight and encumbrance such to limit the handling of the operator.

The personnel of the operation room which is responsible for the treatment and the management of the instrument at the end of each operation has to perform the washing (with suitable disinfectants and detergents) and then the sterilizing of the resterilizable parts (handpiece and wire); the cleaning and the sterilization negatively affect the useful life of the sterilizable components.

The personnel of the operation room must further perform the storing in suitable containers which guarantee the sterility, with a consequent waste of time and space consumption.

Nevertheless the personnel of the operation room must perform the maintenance of the non sterilizable components, i.e. the bracket and the pedal board if present, by making periodical inspections which can require more complex technical interventions by qualified personnel.

The Applicant has also noted that in the present technological solutions in the market or for example described in the aforesaid documents, some non satisfied needs remain and some limits not yet overcome; man maneuverability, ergonomics, safety referring to sterility, simplification of management and maintenance.

SUMMARY OF THE INVENTION

The Applicant has found that with a device for endoscopic resection/removal of the tissues having an electric motor and electric feeding means contained inside the handpiece, it is possible to increase the maneuverability and the ergonomics of the device itself by simplifying at the same time the management and the maintenance.

In one of its first aspects, the invention concerns a device for treatments of endoscopic resection/removal of tissues comprising:a handpiece apt to be held by an user;an external tubular element comprising a proximal end, a distal end and a cutting aperture disposed at said distal end;an internal tubular element apt to be pivotally received in said external tubular element and comprising a proximal end, a distal end and a cutting tip at its distal end;guide means for rotating and/or oscillating said internal tubular element with respect to said external tubular element;

characterized in that:said guide means comprise an electric motor and electric feeding means for the electric motor; andsaid guide means are contained inside said handpiece.

The device for treatments of endoscopic resection/removal of tissues according to the present invention is therefore free from a feeding wire as it has internally the guide means comprising motor and feeding means.

Therefore the ergonomics and the operative flexibility of the devices for treatments of endoscopic resection/removal are remarkably improved.

Nevertheless the personnel of the operation room must not perform anymore the maintenance of components such as the bracket and the pedal board if present, by making inspections which can require more complex technical interventions by qualified personnel.

The present invention, in the aforesaid aspect, can have at least one of the preferred characteristics which are described in the following.

According to a preferred aspect, the handpiece can comprise a control unit for regulating the guide means.

By providing the control unit inside said handpiece the maneuverability and the precision of the device are further improved.

Advantageously, the control unit can comprise at least an electronic circuit for regulating the functions and the speed of the electric motor and a plurality of pushbuttons.

Preferably, the device also comprises a transmission group of the motion actuated by the electric motor for rotating the internal tubular element with respect to the external tubular element.

Advantageously, the transmission group of the motion comprise at least a shaft pivotally supporting the internal tubular element and at least a control pinion which rotates the shaft, actuated by the electric motor.

Advantageously at least the aforesaid shaft can be made of plastic material, in this way further reducing the weight of the device in favour of the ergonomics and maneuverability of the device itself.

Preferably, the device can comprise a cooling circuit having a connection for a suction apparatus and a suction regulating device.

Advantageously the cooling circuit has a heat exchange portion with the electric motor for limiting the heating of the electric motor, in this way increasing the ergonomics of the device. Preferably the suction regulating device comprises a tap and a lever for controlling the tap from outside.

According to an advantageous aspect the electric motor is a brushless motor.

Preferably the handpiece is tight.

Advantageously, at least one between said handpiece and the guide means is disposable.

Preferably only the handpiece is disposable.

Further features and advantages of the invention will be more evident from the detailed description of some preferred but non exclusive embodiments of a device for treatments of endoscopic resection/removal of tissues, according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference toFIGS. 1-3, a device for treatments of endoscopic resection/removal of tissues is indicated with the reference character1.

The device1for treatments of endoscopic resection/removal of tissues comprises a handpiece2apt to be held by an user, an external tubular element3, an internal tubular element4and guide means5for rotating and/or oscillating the internal tubular element4with respect to the external tubular element3.

The external tubular element3comprises a proximal end, a distal end and an aperture and/or cutting window disposed at the distal end.

The internal tubular element4is so shaped and dimensioned to be pivotally received into the external tubular element3and it comprises a proximal end, a distal end and a cutting tip at its distal end, facing the cutting window. The pivotal action of the internal tubular element4produces by abrasion the removal or the finishing of the tissue, and this process is defined as “resection”.

The guide means5comprise an electric motor19and electric feeding means20for the electric motor19. The electric feeding means20and the electric motor19, according to a main aspect of the invention are fully received inside the handpiece2.

The capacity of inserting into the handpiece all the functional parts of the device, in particular the electric motor19and the electric feeding means20, permits to remarkably increase the maneuverability and the precision of motion of the device according to the present invention with respect to the cutting devices present in the market, made by arthroscopy.

The electric motor19is preferably a brushless type motor, but another type of electric motor with suitable dimensions and similar power could be apt to this aim. The motor19is able to rotate at a speed comprised between 400 and 4000 revolutions per minute.

The electric motor19is controlled by a unit that controls each function of the device1, i.e. the starting, rotation or simple oscillation of the internal tubular element4with respect to the external tubular element3and the rotation speed of the internal tubular element4.

The control unit comprises at least a main electronic circuit26, supported by an electronic support circuit22and by an electronic auxiliary circuit25.

The electronic support circuit22extends axially inside the handpiece2between the electric motor19and a container23of the electric feeding means20, described below in more detail.

The main electronic circuit26is connected to pushbutton controls27;28,29which permit to select from outside the type of instruction to send to the main electronic circuit26, i.e. the on or off-switching of the device1, the type of oscillation/rotation of the internal tubular element4and the rotation speed.

Advantageously, a rubber protection30can be provided for the aforesaid pushbutton controls27;28,29.

The device inFIG. 1also shows five LEDs37connected to the control unit to indicate the set rotation speed.

Furthermore, it can be avoided that the personnel of the operation room making the treatment and management of the device must perform at the end of each operation the washing (with suitable disinfectants and detergents) and then the sterilizing of parts of the device.

The personnel of the operation room must not perform the storing of the device in suitable containers which can guarantee its sterility, with a consequent time and space consumption.

As can be seen inFIG. 1, the external tubular element is connected through a locknut35to the handpiece2.

Inside the handpiece2a group of transmission of motion is present, comprising a reducer. In detail, the internal tubular element4is brought by a shaft17which through a motor pinion18functionally connects the internal tubular element with the electric motor19.

Between the motor pinion18and the shaft17a rotary pin of the pinions is also provided with a first reduction36, the pinions of the first reduction37and with trimming washers38, as can be seen inFIG. 3.

The shaft17is supported in a pivotal way by a bearing32and by a bush34, placed at the axially distal end with respect to the shaft17.

Frontally, the group of transmission has a front gasket33, tightly rotating with the shaft17, also comprising two trimming washers15e16. The front gasket33separates the group of transmission from a cooling circuit, as will be better described below.

The electric feeding means20are represented by alkaline batteries or lithium batteries, but any other kind of batteries could be used for this aim without departing from the scope of the present invention. The batteries are housed inside a container23provided at the proximal end of the handpiece2.

The container23has electric connections suitable to feed the electric motor19and a non mobile cover10for changing the batteries and for inspection of the electric connections.

The electric motor19is housed in a motor frame42axially extending inside the handpiece2.

The motor frame42centrally contains the motor pinion18, in a proximal position at least part of the control unit controlling and regulating the motor19and frontally the group of transmission of motion.

Preferably, the device1according to the present invention comprises a suction and cooling circuit, having a connection9for a suction apparatus, outside the handpiece2and not shown in the figures, at least a duct43which guides from said connection9the cooling fluid to the internal tubular element4and to a suction regulating device.

The suction regulating device comprises a tap14and a lever13for controlling the tap14from outside. Advantageously the cooling circuit has a heat exchange portion45with said electric motor19for limiting its cooling.

To this aim, the heat exchange portion45axially extends inside the handpiece1in order to pass axially through the entire motor19.

According to an advantageous aspect of the present invention the handpiece2is tight.

In theFIGS. 4-6an alternative and preferred embodiment of the present invention is shown, completely similar to that ofFIGS. 1-3, except the fact that at least a portion of the device1, and in particular the handpiece2is disposable or single-used. To this aim, the guide means5are housed inside a suitable body40completely housed inside the handpiece2.

In this way, the portion of the device which is more expensive, i.e. feeding means and motor, can be reused.

To permit a simple and rapid extraction of the guide means5with respect to the handpiece2, said handpiece2can comprise a distal portion2asupporting the external tubular element3and the internal tubular element4and a proximal end2bengageable in a non mobile way with the distal portion2a.

The ability to realize some parts, such as the handpiece2, the external tubular element3and the internal disposable tubular element4, i.e. single-used, reduces greatly in any case the problems relating to the storing and the sterilization of such parts by the personnel of the operation room.

Furthermore, the ability to insert inside the body40some functional parts of the device, in particular the electric motor19and the electric feeding means20, permits to remarkably increase the maneuverability and the precision of motion of the device according to the present invention with respect to the cutting devices for arthroscopy, presently existing in the market.

In the embodiment shown inFIGS. 4-6also the control unit is provided in the body40.

The control unit comprises, also in this case, at least a main electronic circuit26, supported by an electronic support circuit and by an auxiliary circuit25.

The main electronic circuit26is connected to pushbutton controls27;28,29which permit to select from outside the type of instructions send to the main electronic circuit26, i.e. the on or off-switching of the device1, the type of oscillation/rotation function of the internal tubular element4and the pivotal speed.

Advantageously on the external handpiece for such aim a rubber protection30for the pushbuttons27;28,29can be provided, in a position corresponding to the aforesaid controls.

Preferably, according to this embodiment, inside the body40a group of transmission of motion is also present, comprising a reducer with satellites.

In detail, the internal tubular element4is brought by a shaft17which by a motor pinion18connects in a functional way the internal tubular element with the electric motor19.

Between the motor pinion18and the shaft17a box145for the reducer with satellites141is also provided, comprising the satellites142and the support shaft143of the satellites.

The group60of the transmission of motion also has two radial bearings144, radially juxtaposed between the motor shaft17and the box of the reducer with satellites.

The motor pinion18engages with the satellites142which transfer the motion to the shaft17, through the support shaft143with satellites.

Alternatively to the just described coaxial transmission group a group of transmission of the chain could be provided, such as the one described in the embodiment ofFIGS. 1-3without departing from the protective scope of the present invention.

The electric feeding means20are represented by rechargeable alkalyne batteries or lithium batteries, but each other type of batteries could be used to this aim without departing from the protective scope of the present invention.

As shown inFIGS. 4 and 5, the batteries are housed inside a container23provided at the more proximal end of the body40.

The container23has the electric connections suitable to feed the electric motor19and a non mobile cover to substitute the batteries and in order to permit inspections of the electric connections.

Preferably the container23is also tight.

In this embodiment, the electric motor19is housed inside the body40axially to the inside of the handpiece2.

The body40centrally comprises the motor pinion18, in a proximal position with respect to the control unit, which controls and regulates the motor19and frontally also the group of transmission of motion.

Preferably, even in this embodiment the device1comprises a suction and cooling circuit comprising a connection9for a suction apparatus, outside the handpiece2and not shown in the figures, at least a duct which from said connection9guides the cooling fluid to the internal tubular element4and a suction regulating device.

The suction regulating device also in this case comprises a tap14and a lever13to control the tap14from outside. Advantageously the cooling circuit has a heat exchange portion with said electric motor19to limit its heating.