Patent Description:
In the medical-diagnostic field, the need to collect samples of biological tissue is known, also from internal organs, in order to carry out subsequent tests on them.

Different types of devices for collecting samples of biological tissue are known. In general, these devices comprise a collecting needle, movable from a non-operating position to an operating position to penetrate into the tissue to be examined, and vice versa.

<CIT> discloses a device for collecting samples of biological tissue according to the preamble of claim <NUM> and which is used in an endoscope.

Other similar devices and endoscopes provided with such devices are dislcosed by <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

However, the known devices appear to have room for improvement, in particular in terms of effectiveness, operating reliability and simplicity of construction.

In particular, a problem often encountered in the known devices is the rigidity of the needle, which makes it difficult to use in conjunction with an endoscope when operating along particularly winding paths or in the presence of obstacles or impediments.

Furthermore, the known devices do not always ensure the collection of samples suitable for subsequent analysis, and therefore it is often necessary to repeat the collection to obtain a suitable sample.

An object of the present invention is to provide a device for collecting samples of biological tissue that overcomes the drawbacks of the known art.

In particular, an object of the invention is to provide a collection device which is extremely effective and reliable.

The present invention therefore concerns a device for collecting samples of biological tissue as defined in the attached claim <NUM> and, for the additional characteristics, as defined in the dependent claims.

The device of the invention for collecting samples of biological tissue is simple to produce and use and fully effective and reliable in the collecting function, being furthermore fully suitable, also due to the flexibility of its end part designed for collecting the samples, for use in conjunction with an endoscope, also within the operating channel of the endoscope.

Further characteristics and advantages of the present invention will become clear from the description of the following non-limiting embodiment examples, with reference to the figures of the attached drawings, in which:.

In <FIG> the number <NUM> indicates overall a device for collecting samples of biological tissue, in particular for collecting tissue samples of internal organs of a human or animal body, comprising a needle <NUM> and a cannula <NUM>, arranged coaxial along an axis A at a distal end <NUM> of the device <NUM> and cooperating to collect a tissue sample; a covering sheath <NUM>, which surrounds the needle <NUM> and the cannula <NUM>; and an actuating mechanism <NUM>, positioned at a proximal end <NUM> of the device <NUM> and connected to the needle <NUM> and to the cannula <NUM> by means of respective operation cables 10a, 10b to move the needle <NUM> and the cannula <NUM> in the sheath <NUM>.

With reference also to <FIG> and <FIG>, the needle <NUM>, made of metallic material for example, extends along the axis A and has a cylindrical stem <NUM> provided with a front tip <NUM> and a rear end element <NUM>, positioned at respective axially opposite ends of the stem <NUM> and delimiting a collecting seat <NUM> shaped to receive a tissue sample.

The tip <NUM> and the end element <NUM> radially protrude from the stem <NUM> and extend radially about the axis A and have a substantially circular cross section.

Preferably, the tip <NUM> and the end element <NUM> have a maximum diameter equal to each other.

The tip <NUM> and the end element <NUM> axially delimit the seat <NUM>, which is positioned on the stem <NUM> between the tip <NUM> and the end element <NUM>.

Advantageously, the seat <NUM> extends all around the stem <NUM> and therefore the axis A and is symmetrical about the axis A.

The tip <NUM> preferably has a double cone shape, having a front conical portion and an opposite rear truncated-cone portion, joined to each other in a maximum diameter section <NUM> of the tip <NUM>.

The end element <NUM> is provided with a front wall <NUM>, which projects from the stem <NUM> and faces towards the tip <NUM> and delimits at the rear the seat <NUM>, and a rear wall <NUM>, opposite the front wall <NUM> and facing towards the actuating mechanism <NUM>; in the embodiment example illustrated, the wall <NUM> is substantially annular around the stem <NUM> and substantially perpendicular to the axis A. The wall <NUM> has an external diameter substantially equal to the maximum diameter of the tip <NUM> (diameter of the section <NUM>).

The end element <NUM> is, for example, substantially cylindrical.

The needle <NUM> is joined, in particular by means of the end element <NUM>, to the cable 10a connected to the actuating mechanism <NUM>.

The cable 10a is a flexible cable, for example metallic, capable of transmitting axial forces in both directions.

In the example illustrated, the cable 10a is fixed (for example, welded) centrally to the rear wall <NUM> of the end element <NUM> and is axially aligned with the stem <NUM>.

Optionally, the position of the end element <NUM> on the stem <NUM> is axially adjustable, for example by means of a threaded coupling or other equivalent system, so as to vary the distance of the end element <NUM>, in particular of the wall <NUM>, from the tip <NUM> and therefore also vary the axial length of the seat <NUM>.

With specific reference to <FIG> and <FIG>, the cannula <NUM> is substantially tubular and internally hollow and extends along the axis A around the needle <NUM>, radially external relative to the needle <NUM>.

The cannula <NUM> comprises an operating portion <NUM>, cooperating with the needle <NUM> to collect the sample, and optionally a flexible connection portion <NUM>, joined to the operating portion <NUM> and positioned around the cable 10a.

The operating portion <NUM> extends axially between a free end <NUM>, having a cutting edge <NUM>; and a root end <NUM>, opposite the free end <NUM> and joined to the connection portion <NUM>.

In further detail, the free end <NUM> has a front opening <NUM> delimited by a peripheral rim <NUM> defining the cutting edge <NUM>; the rim <NUM> is shaped to form at least an axially protruding tip <NUM>; in the preferred embodiment shown, the cutting edge <NUM> is double-pointed and the rim <NUM> has a pair of diametrically opposite points <NUM>, joined by two saddle-shaped rim portions.

The operating portion <NUM> is hollow inside and is provided with an inner chamber <NUM> substantially cylindrical about the axis A, communicating with the opening <NUM>. The chamber <NUM> and the opening <NUM> have an internal diameter substantially equal to the maximum diameter of the tip <NUM> (and of the end element <NUM>).

The connection portion <NUM> is for example defined by a flexible pipe <NUM>, for example a spiral pipe or a pipe with interconnected annular sectors.

In a variation, the operating portion <NUM> of the cannula <NUM> consists of an end portion of the same pipe <NUM>, for example spiral or with interconnected annular sectors, defining the connection portion <NUM>.

The operating portion of the cannula <NUM> is operated by means of the cable 10b connected to the actuating mechanism <NUM>. Also the cable 10b is a flexible cable, for example metallic, capable of transmitting axial forces in both directions.

With specific reference to <FIG> and <FIG>, the sheath <NUM> is radially positioned on the outside of the cannula <NUM> and around the cannula <NUM> along the axis A.

The sheath <NUM> is a flexible tubular sheath, for example made of polymeric material.

In accordance with the invention, also the needle <NUM> and the cannula <NUM> are at least partially substantially flexible.

According to the invention, the stem <NUM> of the needle <NUM> has a diameter and a length such as to be substantially flexible crosswise, even if made of metallic material. Analogously, also the operating portion <NUM> of the cannula <NUM> has a wall diameter and a thickness such as to be substantially flexible crosswise.

In this way, the entire assembly formed of the needle <NUM>, the cannula <NUM>, the respective cables 10a, 10b and the sheath <NUM> is flexible.

The needle <NUM> and the cannula <NUM> are actuated by means of the actuating mechanism <NUM> acting on the cables 10a, 10b.

The actuating mechanism <NUM> can be of different types.

In the preferred embodiment shown in <FIG> and in further detail in <FIG>, the actuating mechanism <NUM> comprises a casing <NUM> which houses a slide <NUM> in which a pair of carriages 32a, 32b are positioned side-by-side.

The slide <NUM> is housed and slides along an axis B in the casing <NUM> and is connected to a recovery button <NUM> protruding from the casing <NUM>.

The slide <NUM> has a pair of guides 34a, 34b parallel to the axis B axially delimited by a front wall <NUM> and a rear wall <NUM> of the slide <NUM>.

The carriages 32a, 32b are housed axially slidable in respective guides 34a, 34b and are connected to the cables 10a, 10b respectively to actuate the needle <NUM> and the cannula <NUM>.

In particular, the carriages 32a, 32b extend along respective longitudinal axes parallel to each other and to the axis B between respective first ends provided with respective heads 38a, 38b fixed to an end of a cable 10a, 10b (arranged passing through a through opening in the front wall <NUM>), and respective second ends provided with respective releasable coupling members 40a, 40b which engage respective triggers 41a, 41b connected to respective shooting buttons 42a, 42b protruding from the casing <NUM>.

The carriages 32a, 32b are connected to respective loading buttons 43a, 43b, which project laterally from the respective carriages 32a, 32b to the outside of the casing <NUM>.

Each carriage 32a, 32b comprises a respective main spring 44a, 44b which extends around the carriage 32a, 32b from the head 38a, 38b towards the rear wall <NUM>; and a return spring 45a, 45b (only one of which can be seen in <FIG>), acting on the respective loading button 43a, 43b and interposed between the loading button 43a, 43b and the rear wall <NUM>.

The device <NUM> is advantageously used in conjunction with an endoscope <NUM>, as shown by way of example in the preferred embodiment of <FIG>.

The device <NUM> is configured so as to be housed (at least partly) inside an operating channel of the endoscope <NUM>, which can be any traditional endoscope.

In particular, the device <NUM> is configured so that the sheath <NUM> containing the needle <NUM> and the cannula <NUM> can be inserted inside an operating channel <NUM> of the endoscope <NUM>; it is understood that the device <NUM> can be used also externally to the channel <NUM> of the endoscope <NUM>.

The endoscope <NUM> comprises a flexible tubular body <NUM> which extends between a head <NUM> and a handgrip (not illustrated), positioned at respective opposite ends of the body <NUM>.

The channel <NUM> is arranged along the body <NUM> inside the body <NUM> and ends with an opening <NUM> in the head <NUM>.

The head <NUM> is provided with an orientation mechanism <NUM>, adjacent to the opening <NUM>, for example a so-called Albarran lever, which can be operated from the handgrip of the endoscope <NUM> (in a known manner) and cooperating with the distal end <NUM> of the device <NUM> to orient the needle <NUM>.

Expediently, the actuating device <NUM> is positioned on the handgrip of the endoscope <NUM>.

In the variation of <FIG>, the device <NUM> is positioned on the outside of the endoscope <NUM>. In particular, the sheath <NUM> which houses the needle <NUM> and the cannula <NUM> of the device <NUM> is arranged adjacent to the body <NUM> along the body <NUM> of the endoscope <NUM> and is supported laterally by the body <NUM>.

With reference also to <FIG>, operation of the device <NUM> is as follows.

At rest, i.e. when the device <NUM> is unloaded, the needle <NUM> and the cannula <NUM> are in respective extracted positions relative to the sheath <NUM> and protrude to the outside of the sheath <NUM> (<FIG>). The needle <NUM> is entirely surrounded by the cannula <NUM>.

Firstly the operator loads the cannula <NUM>, acting on the respective loading button 43b connected to the cannula <NUM> by means of the cable 10b. In particular, the operator moves the carriage 32b in the guide 34b by compressing the spring 44b against the wall <NUM> and causing the releasable coupling member 40b to engage the trigger 41b. The cannula <NUM> retracts with respect to the needle <NUM> and the sheath <NUM> and assumes a retracted position (<FIG>) in which it is entirely housed inside the sheath <NUM> (namely the cutting edge <NUM> does not protrude from the sheath <NUM>).

The operator then loads the needle <NUM>, acting on the respective loading button 43a connected to the needle <NUM> by means of the cable 10a. In particular, the operator moves the carriage 32a in the guide 34a by compressing the spring 44a against the wall <NUM> and causing the releasable coupling member 40a to engage the trigger 41a. The needle <NUM> retracts with respect to the cannula <NUM> and the sheath <NUM> and assumes a retracted position (<FIG>) in which it is entirely housed within the sheath <NUM> (namely, the tip <NUM> does not protrude from the sheath <NUM>).

At this point the device <NUM> is loaded and the operator can introduce the device <NUM> into the endoscope <NUM>, in particular inserting the sheath <NUM> into the channel <NUM> of the endoscope <NUM>.

The operator then operates the endoscope <NUM> to bring the device <NUM> into the organ to be analysed and positions the distal end <NUM> of the device <NUM> in the correct collection direction with the help of the orientation mechanism <NUM> (Albarran lever) of the endoscope <NUM>, if necessary.

At this point the operator releases the needle <NUM>, by pressing the corresponding shooting button 42a which releases the releasable coupling member 40a: the spring 44a moves the carriage 32a and consequently, by means of the cable 10a, the needle <NUM> which comes out of the cannula <NUM> and the sheath <NUM> and assumes the extracted position (<FIG>), penetrating into the tissue from which the sample is to be collected. The penetration depth of the needle <NUM> can optionally be adjusted by the operator.

Subsequently, the operator also releases the cannula <NUM>, by pressing the corresponding shooting button 42b which releases the releasable coupling member 40b: the spring 44b moves the carriage 32b and consequently, by means of the cable 10b, the cannula <NUM> which comes out of the sheath <NUM> and sets to the extracted position (<FIG>) to cover the needle <NUM>, cutting with the cutting edge <NUM> the sample that remains in the seat <NUM>.

The needle <NUM> and the cannula <NUM> are then re-set together to the retracted position (<FIG>), by acting on the recovery button <NUM> which moves the slide <NUM> and drags with it both the carriages 32a, 32b.

The device <NUM> can now be extracted, together with the endoscope <NUM> or separately, to remove the sample from the seat <NUM>.

Optionally, it is possible to remove only the needle <NUM> and the cannula <NUM>, leaving the sheath <NUM> (and the endoscope <NUM>) in position, so that other samples can be collected.

Claim 1:
A device (<NUM>) for collecting samples of biological tissue, comprising a needle (<NUM>) and a cannula (<NUM>), positioned at a distal end (<NUM>) of the device (<NUM>) and coaxially arranged along an axis (A) and slidable with respect to each other along the axis (A); a covering sheath (<NUM>), surrounding the needle (<NUM>) and the cannula (<NUM>); and an actuating mechanism (<NUM>), positioned at a proximal end (<NUM>) of the device (<NUM>) and connected to the needle (<NUM>) and the cannula (<NUM>) for moving the needle (<NUM>) and the cannula (<NUM>) in the sheath (<NUM>); wherein the actuating mechanism (<NUM>) is connected to the needle (<NUM>) and the cannula (<NUM>) by respective flexible operation cables (10a, 10b), capable of transmitting axial forces in both directions; wherein the cannula (<NUM>) comprises an operating portion (<NUM>) cooperating with the needle (<NUM>) to collect the sample and provided, at a free end (<NUM>), with a front opening (<NUM>) delimited by a peripheral rim (<NUM>) defining a cutting edge (<NUM>); and with an inner chamber (<NUM>) substantially cylindrical about the axis (A), communicating with the front opening (<NUM>) and having an inner diameter substantially equal to the maximum diameter of a front tip (<NUM>) of the needle (<NUM>); characterized in that the needle (<NUM>) has a stem (<NUM>) provided with said front tip (<NUM>) and a rear end element (<NUM>), positioned at respective axially opposite ends of the stem (<NUM>) and radially protruding from the stem (<NUM>) and extending radially about the stem (<NUM>) to define a collecting seat (<NUM>) shaped to receive a sample of tissue; and wherein the stem (<NUM>) of the needle (<NUM>) has diameter and length, and the operating portion (<NUM>) of the cannula (<NUM>) has wall diameter and thickness, such as to be substantially flexible crosswise to the axis (A).