WO2015121171A1

WO2015121171A1 - A needle guiding device for ultrasound guided puncture and corresponding kit

Info

Publication number: WO2015121171A1
Application number: PCT/EP2015/052542
Authority: WO
Inventors: Francisco Javier Sala Blanch
Original assignee: Hospital Clínic De Barcelona
Priority date: 2014-02-11
Filing date: 2015-02-06
Publication date: 2015-08-20
Also published as: ES2527336A1; ES2527336B1

Abstract

A needle guiding device for ultrasound guided puncture and corresponding kit. The device comprises coupling means (2) for the ultrasound transducer (100) and which have an examination end (24) and an insertion end (26) of the transducer (100). The longitudinal section of the coupling means (2) defines a main plane (12) of the device. The device (1) comprises a needle (104) support (4) having a guiding opening (6) for the needle (104). The guiding opening (6) tapers progressively such that the needle (104) is guided being able to freely rock on said second end (10), close to the main plane (12) at least in a plane forming an acute angle (α) relative to the main plane (12) and intersecting it downstream of the end (10). The invention also proposes a kit for ultrasound guided puncture containing an ultrasound gel.

Description

A NEEDLE GUIDING DEVICE FOR ULTRASOUND GUIDED PUNCTURE

AND CORRESPONDING KIT

DESCRIPTION

Field of the invention

The invention relates to a needle guiding device for ultrasound guided puncture comprising coupling means configured to receive an ultrasound transducer and having an examination end and an insertion end for the distal end of said transducer, a longitudinal cross section of said coupling means defining a main plane of said guiding device. In particular the invention relates to a device for out-of- plane puncture.

Likewise, the invention relates to a kit for ultrasound guided puncture. State of the art Technically, ultrasonography uses ultrasounds for creating bidimensional images of the interior of the body from the sound wave returned by the body area analyzed. In spite of the fact that 3D ultrasonography currently exists, in the simplest version thereof, which is the one most commonly available in hospitals and in the majority of primary health care centres, the image of the body interior provided by the ultrasonograph is bidimensional, namely it represents a flat cross section of the area explored.

Originally, ultrasonography was a non-invasive diagnostic process. Nevertheless, in recent years, owing to the relative simplicity of use and the reasonable availability of ultrasonographs in hospitals and primary health care centres, the field of application of this technique has gradually widened. Thus, ultrasonography is being increasingly used to perform acts going beyond simple diagnosis, such as, for example, punctures having different medico-surgical purposes. The object of these punctures are operations such as biopsies, drug administration directly to particular areas or on tumour masses, application of anesthetics or others such as fine needle suction of cysts. Generically, this process is known in the art as ultrasound guided puncture. Historically, ultrasound guided punctures have been performed by specialized medical personnel such as, for example, radiologists. Radiologists having extensive experience are capable of undertaking ultrasound guided punctures without the need of any additional support. Nevertheless, the learning of the technique requires much practice.

On the other hand, the ultrasound guided puncture technique has applications in other medical disciplines, in which the specialist physicians are not as experienced as the radiologists and therefore have difficulties for carrying it out. In an attempt to mitigate this problem, needle guiding devices have been developed which are attached to the transducer or examination device of the ultrasonograph. These devices guide the needle in a constant angular position relative to the transducer during the insertion in the patient's body and consequently facilitate the performance of the puncture. The angular position is adjustable, but only before starting the puncture.

The ultrasound transducer has an examination plane corresponding to the plane displayed on the ultrasonograph screen. One first type of known guiding devices is contemplated for guiding the needle in the examination plane of the ultrasonograph. In the art, this approach is known as "in-plane" access. This technique is relatively simple, since during insertion in the patient's body, the needle can be seen at all times on the ultrasonograph screen and therefore the physician knows at what time he has accessed the mass it is wanted to, puncture. JP3127252U or US2010/228131 A1 show in-plane needle guiding devices as explained in this paragraph. The devices disclosed in these documents provide for the possibility of the guiding device changing the angular orientation relative to the transducer as explained in the foregoing paragraph. This allows punctures to be performed at different depths relative to the surface of the epidermis. Nevertheless, the angle of orientation relative to the transducer must be selected beforehand, namely before making the puncture.

Another approach technique used is the one known as "out-of-plane". In this technique, the needle is inserted in the patient's body in a direction slanted at a particular angle relative to the examination plane of the transducer. In this case, the needle moves lengthwise along this direction and intersects the examination plane of the transducer downstream of the latter. The difficulty lies in the fact that the needle is displayed on the ultrasonograph screen only when it crosses the examination plane and only appears as a dot. To facilitate the out-of-plane approach for less experienced users, needle guiding devices have been developed wherein the needle is inserted guided lengthwise along a tubular insertion bore. This bore lies in a plane perpendicular to the examination plane. These devices also contemplate the possibility of changing beforehand the orientation of the puncture so as thereby to modify the targeted depth. To this end, in these devices it is also contemplated that the support guiding the needle may also be discretely orientated in the plane of movement of the needle. For example, WO2013/054168A2 or US2006/002021 1 A1 shows out-of-plane needle guiding devices having the features explained in this paragraph.

All the needle guiding devices for ultrasound guided puncture, both in-plane and out-of-plane allow the needle to be orientated by rocking the needle guide relative to the coupling support to the transducer. Nevertheless, the physician must decide beforehand the orientation of the needle to reach the mass it is desired to puncture. Consequently, the known needle guiding devices for ultrasound guided puncture are not very versatile. In the case of an unsuccessful puncture, the physician is forced to remove the needle and puncture again, which is a very uncomfortable drawback for the patient Summary of the invention

It is an object of the invention to provide a needle guiding device for out-of-plane ultrasound guided puncture which affords versatility to the physician in the positioning of the needle once the mass or tumour on which it is desired to operate has been reached.

This purpose is achieved by a needle guiding device for puncture of the type indicated at the beginning, characterized in that it further comprises a needle support associated with said coupling means having a guiding opening extending between a first end for inserting said needle, remote from said coupling means, and a second end for the exit of said needle, close to said coupling means and located below said first end, and in that between said first and second ends, said guiding opening narrows progressively such that said needle is guided in said second end capable of freely rocking on said second end at least in a plane forming an acute angle relative to said main plane and which intersects said main plane downstream of said second end.

As will be seen hereinafter, in the invention the main plane of the device is substantially parallel to the examination plane of the ultrasound transducer.

In the conventionally known devices, the needle goes in straight and guided along a relatively long tubular longitudinal stretch, whereby it may only move lengthwise inside the guide. In these devices, there is no possibility of rocking the needle, since any modification of the angular position of the needle requires it to be removed and the patient to be punctured again.

The difference of the device of the invention over the conventional devices consists in the needle being able to rock at least laterally within the guiding opening once it has reached the targeted point. Thus, the guiding opening of the device of the invention is configured such that the holding of the needle can be punctual or may be performed along a tubular stretch. Nevertheless, in all the embodiments within the scope of the invention, the needle can rock, at least in one plane. Thanks to this configuration, should it be wanted to reach an area close to that of the initial puncture, the rocking allows the position of the tip to be modified, without it being necessary to puncture the patient again, which notably improves the comfort thereof.

The invention further includes a number of preferred features that are object of the dependent claims and the utility of which will be highlighted hereinafter in the detailed description of an embodiment of the invention.

At times it is necessary for the needle to have still more mobility around the target point to avoid a new puncture. Thus, said guiding opening particularly preferably has a cross section configured such that said needle can pivot about said second end, facilitating the movement of the needle in a three dimensional area about the target point.

In a preferred embodiment, said guiding opening tapers conically between said first and second ends such that the needle can pivot within the limits of the cross section so that the needle will not jam at any point of the perimeter of the cross section, thereby enhancing the smoothness and progressivity of manipulation of the needle during the pivoting. Particularly preferably, the cross section of the cone will be circular or elliptical.

In an additional improvement of the invention it is contemplated that the guiding device comprises hinge means between said needle support and said coupling means, such that said needle support is mounted rockingly about an axis relative to said coupling means. This feature allows different needle insertion depts. To be achieved, namely, the greater is the rocking angle of the needle support, the shallower will be the puncture performed relative to the epidermis.

In certain ultrasound guided punctures, greater positional accuracy may be necessary at the time when the target point of the puncture has been reached. Therefore, to this end, where the needle support can rock relative to the transducer, it is preferably contemplated that the guiding device comprises retaining means between said needle support and said coupling means, said retaining means being configured to lock the angular position of said needle support relative to said coupling means.

In addition, a further object of the invention consists of the rocking configuration of the guiding device being as simple as possible. Thus, the means for retaining the needle support relative to the coupling means consist of a positive fit between said needle support and said coupling means with a plurality of discrete retaining points.

A further problem associated with ultrasound guided punctures is the hygiene. To avoid soiling the transducer or direct contact with the skin of different patients, the specialist commonly places it in an elastic latex bag adjusted to the transducer. Then, once the transducer has been covered, the specialist mounts the guiding device in contact with the bag. This operation is laborious and rather imprecise. To solve this problem, in another preferred embodiment, said coupling means are a closed cap made from a material permeable to the ultrasounds, which forms a physical barrier between the distal end of the transducer and the patient's skin.

In an optional improvement of the invention, it is contemplated that holding tabs for said guiding device project from said insertion end, said tabs being configured to allow the placing of at least the thumb of a user on one tab and the index and middle fingers on the opposite tab, to hold said transducer at a point remote from the distal examination end thereof, without direct contact therewith. In the invention, the size of the fingers corresponds to the average size of the fingers of an ultrasonograph user, which automatically eliminates the hands of a child. Thus, for example, some dimensions deemed to be sufficient for the placing of a user's index and middle fingers on one of the tabs correspond to a tab projecting at least 3 cm relative to the insertion end. A further problem appearing when mounting the guiding device, particularly if the transducer is covered with an appropriate latex prophylactic consists of that at times the attachment between both parts is unsatisfactory. To solve this problem, in a preferred embodiment, when the device has tabs, it is contemplated that each of the tabs should comprise a plurality of lateral notches on at least one of its sides, each notch being configured to accommodate a rubber band stretched across at least one notch of each tab, to exert a compressive force of said tabs on said transducer, with said notches preventing the sliding of said rubber band along the sides of said tabs.

Also in a preferred embodiment of the device, said second end is manufactured from an elastically deformable elastomeric material, such that the elastic deformation of said elastomeric material allows said needle to freely pivot about said second end. Alternatively, in another embodiment, with the same idea, said second end comprises a ball joint rotatably mounted relative to said needle support such as to allow said needle to freely pivot about said second end. In both cases, in comparison with the practically punctual guidance afforded by the wall thickness of the second end, length of guidance is obtained, which improves the accuracy and directivity during the puncture. Nevertheless, the possibility of rocking or pivoting about the terminal end of the needle support is equally guaranteed.

The invention also addresses the problem of providing a needle guide kit for out-of- plane ultrasound guided puncture which reduces the potential risks of infection for the patient.

It has been shown that the ultrasound gel is marketed in deformable tube or bottle form. This type of packaging contains multiple gel doses. This means that one same gel packaging lasts for several days, is used a multiplicity of times and on different patients. As a result, the packaging is handled in conditions that are not always aseptic. It has already been mentioned that to reduce as far as possible the focus of infections from the transducer, it is usual to protect the distal end thereof with a sort of latex prophylactic appropriate for this purpose. Nevertheless, conventionally, no similar solution is known to avoid the propagation of germs by way of the gel packaging. This same tube is handled a multiplicity of times like the transducer with the consequent risk of transmission of dirt and bacteria. To avoid this problem, there is contemplated in the invention a kit for ultrasound guided puncture comprising a packaging with at least one first and one second independent compartments, said first compartment containing a needle guiding device of the invention and said second compartment an ultrasound gel. This facilitates the creation of a disposable consumable and guarantees that the handling thereof is unique for each operation.

Also, depending on the operation that it is desired to perform with the needle, it may be necessary to have sterile conditions available. To this end, said needle guiding device and said ultrasound gel are preferably contained in said packaging under sterile conditions. In the invention, the idea of sterile must be understood as a state free from pathogenic germs.

Finally, a further object of the invention consists of the kit being an easy-to-handle low cost consumable. To this end, said packaging is preferably a packaging formed by a sheet of heat welded plastic and aluminium, with at least one controlled predetermined breaking point for each of said first and second independent compartments.

Likewise, the invention also includes other features of detail illustrated in the detailed description of an embodiment of the invention and in the accompanying figures.

Brief description of the drawings

Further advantages and features of the invention will become apparent from the following description, in which, without any limiting character, preferred embodiments of the invention are disclosed, with reference to the accompanying drawings in which: Figure 1 is a top perspective view of a first embodiment of the needle guiding device for ultrasound guided puncture according to the invention. Figure 2 is a front view of the means for coupling to the examination end of an ultrasound transducer, of the device of Figure 1 , without the needle support.

Figure 3 is a top plan view of the coupling means to the examination end of an ultrasound transducer, without the needle support.

Figure 4 is a vertical section side view of a needle guiding device for ultrasound guided puncture during the out-of-plane approach in several differentiated angular positions. Figure 4A is a longitudinal section detail of the needle support of the device of Figure 4.

Figure 5 is a front view of the needle guiding device for ultrasound guided puncture during an out-of-plane approach in two different angular positions.

Figure 6 is a front sectional view on the central plane of the needle guiding device for ultrasound guided puncture, during an in-plane approach.

Figure 7 is a front view of a kit for ultrasound guided puncture according to the invention.

Figure 8 is a vertical cross section view of a second embodiment of the needle guiding device for ultrasound guided puncture during an out-of-plane approach. Figure 9 is a part sectional view on the central plane of the needle guiding device for ultrasound guided puncture of Figure 8. Figure 10 is a vertical section side view of a third embodiment of the guiding device according to the invention.

Figure 1 1 is a vertical section side view of a third embodiment of the guiding device according to the invention.

Detailed description of embodiments of the invention

In Figures 1 to 7 there is to be seen a first embodiment of the needle 104 guiding device 1 for ultrasound guided puncture according to the invention.

The guiding device 1 is formed fundamentally of two parts. The first part is the main body and the second is the needle 104 support 4. Particularly preferably and with the view to reducing costs, the guiding device 1 is manufactured by injection moulding of a medical grade thermoplastic.

In the first embodiment, the main body consists of a hollow casing forming hood-like coupling means 2. These coupling means 2 are configured to snugly receive an ultrasound transducer 100. To this end, the inner walls of the main body are adjusted to the shape of the transducer 100 and intimately enclose it. Nevertheless, the snug reception of the transducer 100 does not of necessity imply that the container has to be a press fit. As explained above, one cannot discard the idea that the guiding device 1 may be used with the transducer 100 wrapped in a latex covering which is not shown in the figures. To this end, sufficient clearance may be provided to allow assembly on the transducer 100 covered with a prophylactic.

The coupling means 2 have an examination end 24 and an insertion end 26. In this embodiment, the examination end 24 is closed, as shown in Figure 4, and is made from a material permeable to ultrasounds. Nevertheless, these are not essential features of the invention. On the opposite side of the guiding device 1 , the insertion end 26, which is open, corresponds to the opening through which the distal end of the transducer 100 is inserted. When the guiding device 1 is observed from the front over its maximum width, see Figure 2, the mean longitudinal section of the coupling means 2 defines a main plane 12 of the guiding device 1 , shown in Figure 3. This main plane 12 usually coincides with the examination plane of the transducer 100 of the ultrasonograph. Nevertheless, this coincidence between the main plane 12 of the guiding device 1 and the examination plane of the transducer is not essential for the invention either.

As already mentioned above, the second essential part of the guiding device 1 is the needle 104 support 4. In this case, the support 4 is associated with the coupling means 2 by way of two lateral ribs 36. Alternatively, the support 4 could be connected with a single lateral rib. Nevertheless, the embodiment shown in the figures improves the guiding of the support 4 relative to the main body. In addition, the guide support 4 has a guiding opening 6 in which the needle 104 is inserted. The guiding opening 6 extends between a first and a second ends 8, 10 of the support 4.

As may be seen in Figure 4, the needle 104 is inserted in the first end 8, which is remote from the coupling means 2. The needle 104 exits through the second end 10, guided in the direction of the patient's epidermis 106. In the examination position of the transducer 100, the second end 10 is below the first end 8 and, therefore, closer to the coupling means 2. As may be seen in Figure 5, the guiding opening progressively grows narrower between the first and second ends 8, 10. In the broadest embodiment of the invention, it is contemplated that this narrowing be a cone having a circular, elliptical base or a pyramid having a square or polygonal base. It is not discarded either that the narrowing be simply a groove of the thickness of the needle 104 which narrows triangularly allowing only the lateral rocking of the needle 104 shown in Figure 5. In any case, in the broadest embodiment of the invention, the narrowing allows the needle 104 to be guided in the second end 10 such that it may at least rock freely on the second end 10. It will be seen from Figure 4A that the guiding of the needle 104 in the second end 10 in this embodiment corresponds to the thickness of the wall. A priori, the device of the invention is devised for use with different needle gauges. Thus, in this embodiment, the device 1 is provided with a through hole 54 corresponding to the largest gauge needle 104 that it is wanted to use. When the physician uses the largest gauge needle 104, the needle 104 is a close fit in this through hole 54 as is to be seen in Figure 4A, but it can rock as mentioned above. On the other hand, if a smaller gauge is used, there will be a slight play between the needle 104 and the through hole 54. Nevertheless, the through hole 54 still delimits the rocking or pivoting movement of the needle 104.

The rocking of the needle 104 takes place on at least one plane, which corresponds to the plane passing through the axis of the two needles 104 shown in Figure 5. Thus the plane of rocking is orientated relative to the main plane 12 forming an acute angle a. As may be seen in the figure, this plane of rocking intersects the main plane 12 downstream of the second end 10 of the support 4, at point A in Figure 4.

The effect of the lateral rocking of the needle 104 is to be seen in Figure 5. Herein there is shown the epidermis 106 and an internal tumour 108 in a simplified manner. When the puncture is offset relative to the tumour 108, the lateral rocking of the needle 104 about the second end 10 allows the puncture to be corrected in an ongoing way without the need to perform a new puncture, conferring versatility on the guiding device 1 and a notable increase in comfort for the patient.

On the other hand, it should be pointed out that it is not essential for the invention for the second end 10 to be open prior to use of the guiding device 1 . In an optional embodiment such as the one shown in Figure 10, the second end 10 can be closed, but having a wall thickness which is easily perforable by the needle 104, which guarantees a very close guiding between the needle 104 and the support 4. Optionally, this part could be overmolded in elastomeric material, to perforate the wall of the guiding opening 6. In spite of this, the characteristics of the elastomeric material have to avoid any entrainment of part of the material during the perforation with the needle 104.

In its most general form the guiding device 1 must allow the needle to rock at least laterally. Nevertheless, as may be seen in Figures 1 to 7, the guiding device 1 of this embodiment not only allows lateral rocking. Since the guiding opening 6 has a cross section which tapers conically and in particular in the form of a cone having an elliptical base, the needle 104 may also pivot about the second end 10. Thus, the needle 104 may move in any direction within the limits defined by the elliptical base of the first end 8. This freedom of movements of the tip of the needle 104 provides for great mobility of the needle 104 in the guiding device 1 and avoids that any slight error during the insertion should force the physician to perform a second puncture.

Furthermore, in order to controllably vary the depth of the puncture, the first embodiment of the guiding device 1 allows the support 4 to rotate relative to the coupling means 2. Nevertheless, the regulation of the angular position relative to the examination plane must be effected prior to inserting the needle in the skin. For this regulation of the orientation there are provided hinge means 40 between the support 4 and the ribs 36 of the coupling means 2 and thus the support 4 can rock or rotate about the axis 42. To be precise, the hinge means 40 consist of pivots 56 projecting from the lower portion of the cone defining the guiding opening 6.

On the other hand, the rotation of the support 4 relative to the coupling means 2 could be effected continuously. Nevertheless, to facilitate the approximate determination of the puncture depth, the guiding device 1 comprises retaining means 14 between the support 4 and the discrete coupling means 2. In this case, the retaining means 14 consist of a plurality of notches 58 provided on the ribs 36 and lateral pivots 60 on the support 4, which positively engage in the notches 58 and therefore lock the discrete position of the support 4. In this case, these notches allow five puncture depths p1 to p5 in Figure 4 to be determined. It is not essential for the puncture depths p1 to p5 to be constant. Nevertheless, in a preferred embodiment the consecutive puncture depths p1 to p5 are constant. Also to facilitate the mobility of the support 4 relative to the coupling means 2, there is provided a tongue 44 allowing the support 4 to be pulled and pushed to rotate relative to the ribs 36.

On the other hand, on one of the sides perpendicular to the examination plane of the transducer 100, the guiding device 1 has a second support 46 for the needle 104 for carrying out an approach in the examination plane. Particularly preferably, the guiding opening which in this case is the second guiding opening 48 also tapers in such a way that its end close to the epidermis 106 is held and can rock only in the examination plane.

To guarantee an easy manipulation of the transducer 100, holding tabs 28 project from insertion end thereof. The tabs 28 have the shape of a substantially trapezoidal sheet and are sufficiently large to allow the placement of at least the thumb on one tab 28 and the index and middle fingers on the opposite tab 28. Furthermore, to achieve a simple and effective holding, on each of their sides 32 the tabs 28 have a plurality of lateral notches 34. These notches 34 are configured to receive a tensioned rubber band not shown in the figures. In this way when placing the guiding device 1 around the transducer 100, the rubber band is retained in one of the notches 34 of each side 32, without the possibility of longitudinal sliding and compressing the tabs 28 against the walls of the transducer 100 to prevent relative movements between both parts.

The guiding device 1 according to the invention may be reused many times if correctly sterilized. Nevertheless, to guarantee optimal conditions of hygiene the invention also provides that the guiding device 1 should be a disposable consumable offered as a kit. The kit according to the invention must be as economical and simple as possible, guaranteeing optimal and preferably sterile conditions of hygiene. It has been established that in spite of the guiding device 1 being sterile, a second focus of propagation of dirt and germs comes from the multidose packagings of ultrasound gel. To avoid this drawback, in an embodiment not shown in the figures, the kit for ultrasound guided puncture comprises a blister or similar type packaging containing the guiding device 1 according to the invention and a single dose metering device of ultrasound gel similar to a tube of toothpaste or the like. Nevertheless, in a preferred embodiment shown in Figure 7, the puncture kit is provided in a packaging 16 of a heat welded sheet formed by plastic and aluminium. The packaging 16 has first and second independent compartments 18, 20. The first compartment 18 contains the needle 104 guiding device 1 , while in the second compartment there is stored a single dose of ultrasound gel 22. If the physician wears latex gloves, it may be difficult to open the packaging 16. Thus, to facilitate the opening thereof, the packaging 16 has a saw-tooth profile at the top and bottom ends of the packaging. This profile forms controlled predetermined breaking points 30 for access to each compartment Furthermore, if optimal conditions of hygiene are required, it is contemplated that both compartments 18, 20 and their contents be sterilized. All of this leads to the device and gel being in hygienically optimal conditions at all times, but offers the additional advantage that the packaging 16 is handled only once. The consequence of all this is a drastic reduction in the risk of the device and gel carrying dirt or pathogenic germs that could affect the patient.

Concerning hygiene, another relevant advantage of this first embodiment consists of the casing defining a closed body. Consequently, at no time does the transducer 100 make contact with the patient's skin and the risk of infection is also reduced.

Hereinafter alternative embodiments of the guiding device 1 according to the invention are explained. These variants have many features in common with the embodiment explained up to here, such that the description of all these common features is deemed to be explained in the foregoing paragraphs.

The embodiment of Figures 8 and 9 has as the most relevant differentiating feature the fact that the coupling means 2 are open at the examination end 24. For simplicity, this has not been shown in the figures but in this case the usual thing is for the transducer 100 to be covered with a plastic prophylactic type wrapping devised for this application. Figure 10 shows a third embodiment for improving the accuracy of insertion of the needle 104. To this end, unlike the embodiment of Figures 1 to 7, the second end 10 is made from an elastically deformable elastomeric material. This plug of elastomeric material may have an insertion opening with a conical mouth 2 to facilitate the correct introduction of the needle 104. Optionally, the material may be sufficiently soft so that it has to be perforated with the needle. Nevertheless, particularly preferably, the second free end 10 has a through hole of a diameter corresponding to the smallest gauge of needle 104 that it is desired to use. This guarantees than no material is entrained since the needle finds a pre-established passage.

The plug 62 of elastomeric material is elastically deformable such that the deformation allows the needle 104 to freely pivot about the second end 10, with the advantages explained in foregoing paragraphs. Also in an alternative embodiment, the plug 62 of elastomeric material is incorporated in the puncture needle and has such a configuration that said plug 62 is interlocked in said second end 10 when the needle 104 is inserted fully to abut against the second end 10 of the guiding opening 6. This operation is carried out prior to the puncture. Thereafter, when the needle is already coupled and can move lengthwise relative to the support 4, the desired puncture may be made. In this embodiment, there is clearly seen also the advantage of the invention, namely that with the phantom lines A and B the limits of rocking movement of the needle 104 are shown. Particularly preferably, the first end 8 is configured so that in the position B of the needle 104 the needle can be moved angularly to attain at least the depth p1 to p5 immediately above, whereas in the position A of the needle 104 there may be reached at least the depth immediately below. Thanks to this, still more versatility is achieved and new undesired punctures are avoided.

In the fourth alternative embodiment shown in Figure 1 1 , the second end 10 has a ball joint 64 mounted in the second end 10 and rotatable in the needle 104 support 4. Like in the previous case, this ball joint 64, on rotating freely, facilitates the pivoting of the needle 104 once the target of the puncture has been attained.

Optionally, the kit according to the invention may comprise a plurality of balls 64. In this case, each of them has the tubular passage hole of a particular needle gauge.

In a first embodiment, the assembly of the ball joint 64 may be made by a snap fit at the second end 10 by first inserting the needle 104 in the hole of the ball joint 64 and then inserting this assembly inside the guiding opening 6 until it abuts the second end 10.

In another alternative embodiment the balls 64 of the kit are pre-mounted in a separate hood of the support 4. This hood has appropriate means for mounting in the needle support 4. For example, the hood may be mounted on the support 4 under pressure, by snap fit, by screwing or in any other way common in the art.

Claims

1 . - A needle (104) guiding device (1 ) for ultrasound guided puncture, comprising coupling means (2) configured to receive an ultrasound transducer (100) and having an examination end (24) and an insertion end (26) for the distal end of said transducer (100), a longitudinal section of said coupling means (2) defining a main plane (12) of said guiding device (1 ), characterized in that it further comprises

[a] a needle (104) support (4) associated with said coupling means (2) having a guiding opening (6) extending

[i] between a first end (8) for insertion of said needle (104), remote from said coupling means (2) and

[ii] a second end (10) for the exit of said needle (104) close to said coupling means (2) and located below said first end (8) and in that [b] between said first and second ends (8, 10) said guiding opening (6) tapers progressively such that said needle (104) is guided in said second end (10) being able to freely rock on said second end (10), at least in a plane forming an acute angle (a) relative to said main plane (12) and intersecting said main plane (12) downstream of said second end (10).

2. - A needle (104) guiding device (1 ) for ultrasound guided puncture according to claim 1 , characterized in that said guiding opening (6) has a cross section configured such that said needle (104) may pivot about said second end (10).

3.- A needle (104) guiding device (1 ) for ultrasound guided puncture according to claim 2, characterized in that said guiding opening (6) tapers conically between said first and second ends (8, 10).

4.- A needle (104) guiding device (1 ) for ultrasound guided puncture according to any one of claims 1 to 3 characterized in that it comprises hinge means between said needle (104) support (4) and said coupling means (2) such that said needle (104) support (4) is mounted rockingly on an axis (42) relative to said coupling means (2).

5.- A needle (104) guiding device (1 ) for ultrasound guided puncture according to claim 4, characterized in that it comprises retaining means (14) between said needle (104) support (4) and said coupling means (2), said retaining means (14) being configured to lock the angular position of said needle (104) support (4) relative to said coupling means (2).

6.- A needle (104) guiding device (1 ) for ultrasound guided puncture according to claim 5, characterized in that said retaining means (14) consist of a positive fit between said needle (104) support (4) and said coupling means (2) with a plurality of discrete retaining points.

7.- A needle (104) guiding device (1 ) for ultrasound guided puncture according to any one of claims 1 to 6, characterized in that said coupling means (2) are a closed hood of a material permeable to ultrasounds.

8. - A needle (104) guiding device (1 ) for ultrasound guided puncture according to any one of claims 1 to 7, characterized in that holding tabs (28) for said guiding device (1 ) project from said insertion end (26), said tabs (28) being configured to allow the placement of at least the thumb of a user on one tab (28) and the index and middle fingers on the opposite tab (28) for holding said transducer (100) at a point remote from the distal examination end thereof without direct contact thereon.

9. - A needle (104) guiding device (1 ) for ultrasound guided puncture according to claim 8, characterized in that each of said tabs (28) comprises a plurality of lateral notches (34) on at least one of its sides (32), each notch (34) being configured to accommodate a rubber band tensioned across at least one notch of each tab (28) to exert a compressive force of said tabs (28) on said transducer (100), and said notches (34) preventing the sliding of said rubber band along the sides (32) of said tabs (28).

10.- A needle (104) guiding device (1 ) for ultrasound guided puncture according to any one of claims 1 to 9, characterized in that said second end (10) is made from an elastically deformable elastomeric material such that the elastic deformation of said elastomeric material allows said needle (104) to freely pivot about said second end (10).

1 1 : A needle (104) guiding device (1 ) for ultrasound guided puncture according to any one of claims 1 to 9, characterized in that said second end (10) comprises a ball joint rotatably mounted relative to said needle (104) support (4) such as to allow said needle (104) to freely pivot about said second end (10).

12. - A kit for ultrasound guided puncture (50) characterized in that it comprises a packaging (16) having at least a first and a second independent compartments (18, 20), said first compartment (18) containing a needle (104) guiding device (1 ) according to any one of claims 1 to 1 1 and said second compartment (20), an ultrasound gel (22).

13. - A kit for ultrasound guided puncture (50) according to claim 12 characterized in that said needle (104) guiding device (1 ) and said ultrasound gel are contained in said packaging under sterile conditions.

14. - A kit for ultrasound guided puncture (50) according to claim 12 or 13, characterized in that said packaging (16) is a packaging formed by a heat welded sheet composed of plastic and aluminium, with at least one controlled predetermined breaking point (30) for each of said first and second independent compartments (18, 20).