WO2006136588A1

WO2006136588A1 - Biopsy device

Info

Publication number: WO2006136588A1
Application number: PCT/EP2006/063428
Authority: WO
Inventors: Armando Belluomo
Original assignee: H.S. - Hospital Service - S.P.A.
Priority date: 2005-06-22
Filing date: 2006-06-21
Publication date: 2006-12-28
Also published as: ITMO20050158A1

Abstract

A biopsy device (1) comprising a body (2), a mandrel (5) near the distal end of which a housing (8) is obtained intended to receive a sample of organic tissue to be taken, said mandrel (5) being provided with an axial hole (9) extending from a proximal end of the mandrel to said housing (8) and with a groove (10) extending on the bottom of said housing and aligned with said axial hole (9) , a hollow needle (7) having a proximal end, fixed to said body (2) and into which said mandrel (5) is insertable and which is movable with respect to said mandrel (5) in a direction parallel to a longitudinal axis of the mandrel (5) ; the device (1) furthermore comprises cannula means (12) insertable into said axial hole (9) and into said groove (10), said cannula means (12) being closed at a distal end and being provided, on a surface portion facing the exterior of said housing (8) , with a plurality of through openings (13) .

Description

Biopsy device

The present invention relates to a biopsy device of the guillotine type, i.e. of an instrument for taking samples of fragments of organs or tissues from patients to diagnose the nature of a pathological process. The biopsy device according to the invention is in particular suitable for taking samples of soft and/or compressible tissues. From the state of the art biopsy devices of the so-called "guillotine" type are known that comprise a substantially cylindrical mandrel, near the tip of which a housing is obtained - for example obtained by making a flattening along a portion of the mandrel - suitable for receiving the sample to be taken, and a hollow needle or cannula, with a cutting tip, slidingly coupled externally to said mandrel. The housing has dimensions that are such as to receive a tissue sample of sufficient size for the histological examinations to be conducted thereupon.

The mandrel and the hollow needle are fixed to a movable body that controls the relative displacements of the mandrel and hollow needle. The movable body is inserted inside a grip that enables the operator to manoeuvre the biopsy device .

In order to conduct the biopsy, the device is introduced into the body of the patient, with the mandrel retracted inside the hollow needle so that only the tip thereof protrudes . When the tip of the mandrel has reached the zone of the body of the patient from which the sample has to be taken the mandrel is made to emerge from the needle by reciprocal axial sliding. In this way a portion of the tissue surrounding the mandrel surrounds the housing obtained on the mandrel. At this point the hollow needle is moved forwards until it covers said housing in such a way that the cutting tip of the hollow needle separates, with a guillotine action, the portion of tissue that has penetrated into the aforementioned housing. Lastly, the device is extracted from the body of the patient. During the performance of the biopsy the tissue surrounding the tip of the mandrel may, however, not penetrate into the housing, with the consequence that the biopsy has to be repeated. In order to overcome this drawback, biopsy needles have been proposed, in which the mandrel is provided with an axial hole that extends at least from the rear end of the mandrel to the housing intended to receive the tissue sample. Through this axial hole it is possible to carry out suction that causes a vacuum in the housing, thus facilitating the entry thereinto of the tissue surrounding the tip of the mandrel. The axial hole can be extended also through the tip of the mandrel to use the latter as a needle for injecting a liquid substance, for example a drug, or for sucking organic liquids .

A biopsy device of this type is known, from example from EP 1 266 624, in the name of the applicant.

The aforementioned type of biopsy device nevertheless has some drawbacks. Above all, the vacuum that is achievable through the axial hole of the mandrel acts substantially only in the rear zone of the housing and may not therefore be sufficient to ensure the entry thereinto of a portion of tissue. Furthermore, in the embodiment of the device in which the axial hole protrudes also through the tip of the mandrel, there is the risk that cellular material, possibly infected, may introduce itself inside the tip of the mandrel, which remains exposed even after the hollow needle has covered the housing of the mandrel and be thus be conveyed to the zones affected by the extraction path of the device, which zones could be contaminated by this cellular material .

Biopsy devices are furthermore known in which a conduit is provided that communicates through a series of holes with the bottom of the housing made in the mandrel in such a way that a vacuum generated in said conduit acts on the entire lower zone of the housing, thus being particularly effective in ensuring penetration of the tissue into the housing. These devices nevertheless have the drawback of requiring a mandrel of larger dimensions, which thus makes the performance of the biopsy more painful for the patient.

An object of the present invention is to provide a biopsy device that ensures the penetration of the tissue sample into the housing of the mandrel, thus eliminating the risk of a repetition of the biopsy, without requiring an increase in the dimensions of the mandrel.

A further object of the present invention is to provide a biopsy device that eliminates the risk of contamination of tissues during the phase of extraction of the device from the body of the patient. According to the present invention a biopsy device is provided comprising a mandrel near the distal end of which a housing is obtained that is suitable for receiving a sample of organic tissue to be taken, said mandrel being provided with an axial hole extending at least from a proximal end of the mandrel to said housing and with a groove extending on the bottom of said housing and aligned with said axial hole, a hollow needle in which said mandrel is insertable and which is movable with respect to said mandrel in a direction parallel to a longitudinal axis of the mandrel, characterised in that it further comprises cannula means that is insertable into said axial hole and into said groove, said cannula means being closed at the distal end thereof and being provided, on a surface portion facing the exterior of said housing, with a plurality of through openings .

Owing to the invention, it is possible to make an effective vacuum in the housing of the mandrel, to ensure the presence of the tissue in the interior thereof before making the hollow needle advance, without thereby increasing the dimensions of the mandrel. In a version of the invention the tip of the mandrel is provided with a further axial hole aligned on said groove, said cannula being insertable into said further axial hole. The possibility of inserting the cannula means into the axial hole of the tip of the mandrel enables it to be prevented that biological material, possibly infected, is able to penetrate into the tip of the mandrel during the insertion of the latter into the body of the patient and is able to contaminate the tissues of the patient whilst the mandrel is being extracted.

Some embodiments of the invention are disclosed below, with reference to the attached drawings, in which:

Figure 1 is a view from above of a biopsy device according to the invention; Figure 2 is a view from above of a distal portion of the device according to the invention, in a first embodiment; Figure 3 is a longitudinal section of Figure 2; Figure 4 is a longitudinal section like the one in Figure 3, without the cannula means; Figure 5 is a view from above of a distal portion of the device according to the invention, in a second embodiment; Figure 6 is a longitudinal section of Figure 5; Figure 7 is a longitudinal section like the one in Figure 6, without the cannula means . With reference to Figure 1, 1 indicates a device according to the invention comprising a body 2 provided with gripping means 3 to which a hollow needle 7 is fixed, inside which a mandrel 5 is slidingly coupled, ending at a proximal end thereof, in a grip 4 and, at a distal end thereof, in a tip 6, near which there a housing 8 is provided intended to receive a sample of organic tissue. The housing 8 can be obtained by creating a flattening on the mandrel 5. In the mandrel 5 an axial hole 9 is made that extends from the proximal end of the mandrel to lead into the housing 8 continuing into the housing in the form of a groove 10 that ends at the tip 6 of the mandrel. The groove 10 preferably has the shape of a cylindrical surface sector, with a radius that is substantially equal to the radius of the axial hole 9.

The device according to the invention is completed by a cannula 12, closed at a distal end thereof, that is insertable in the aforesaid hole 9 and into the groove 10 until it reaches the distal end thereof in contact with th rear part of the tip 6 of the mandrel 5. The cannula 12 is provided with a plurality of holes 13, for example aligned on one another, arranged on a portion of cannula that, when the latter is positioned as indicated above, are located at the housing 8, facing the exterior of the housing. The near end of the cannula 12 is connectable, for example by means of a suitable connecting means made in the body 2 to a sucking device suitable for creating a vacuum inside the cannula 12.

By making a vacuum inside the cannula 12, after the mandrel has been inserted into the patient and the hollow needle 7 has been retracted uncovering the housing 8, through the holes 13 suction of a portion of tissue surrounding the housing 8 is obtained that thus penetrates the housing, so that subsequent advancing of the hollow needle 7 separates from the surrounding tissue said portion of tissue, that thus remains trapped inside the housing 8, between the housing and the internal wall of the hollow needle 7. Owing to the cannula 12 with the holes 13 it is possible to make a biopsy device that is simple and of modest dimensions that ensures the taking of the tissue sample substantially at each attempt .

The relative shifts between hollow needle 7 and mandrel 5 are obtained by sliding with respect to the mandrel the body of the device, to which the hollow needle 5 is fixed, gripping the body 2 and the mandrel 5 by means of the respective grips 3 and 4. In Figures 5, 6 and 7 there is illustrated a second embodiment of a biopsy device according to the invention. In this second embodiment, in the tip 6 of the mandrel 5 a further through hole 11 is obtained, aligned with the through hole 9 of the body of the mandrel and with the groove 10. The further through hole 11 preferably has the same radial dimensions as the through hole 9. Owing to the presence of the further hole 11, the mandrel 5 can be used to suck, like a syringe, organic liquids, or to inject liquid substances into the body of the patient, for example medicinal substances .

The cannula 12 has a sufficient length to be introduced into the holes 9, 11 and into the groove 10, until it reaches with the closed distal end thereof the end of the tip 6 of the mandrel. With the cannula 12 inserted, the further hole 11 is completely obstructed and there is no risk that organic material may penetrate therein during performance of a biopsy and contaminate the tissues of the patient along the path along which the mandrel is extracted from the body of the patient. The distal end of the cannula 12 has a shape corresponding to the shape of the distal end of the tip 6 of the mandrel, in order to ensure complete occlusion of the through hole 11. For example, if the tip of the mandrel is shaped like the mouth of a flute also the distal end of the cannula 12 will be shaped in the same way.

Also in this second embodiment of the invention, the position of the holes 13 in the cannula 12 is chosen in such a way that when the cannula has been introduced into the holes 9, 11 and into the groove 10, they are positioned at the housing 8.

In the practical embodiment, the materials, the dimensions and the constructional details may be different from those indicated but be technically equivalent thereto without falling outside the realm of legal protection of the present invention.

Claims

1. Biopsy device (1) comprising a body (2), a mandrel (5) near the distal end of which a housing (8) is obtained, intended to receive a sample of organic tissue to be taken, said mandrel (5) being provided with an axial hole (9) extending from a proximal end of the mandrel to said housing (8) and with a groove (10) extending on the bottom of said housing and aligned with said axial hole (9) , a hollow needle (7) having a proximal end fixed to said body (2) and in which said mandrel (5) is insertable and which is movable with respect to said mandrel (5) in a direction parallel to a longitudinal axis of the mandrel (5) , characterised in that it further comprises cannula means (12) that is insertable into said axial hole (9) and into said groove (10), said cannula means (12) being closed at a distal end and being provided, on a surface portion facing the exterior of said housing (8) , with a plurality of through openings (13) .

2. Biopsy device (1) according to claim 1, wherein said through openings are aligned in a direction parallel to a longitudinal axis of the cannula (12) .

3. Biopsy device (1) according to claim 1, or 2 wherein a proximal end of said cannula (12), opposite said distal end, is connectable to a sucking device.

4. Biopsy device (1) according to any preceding claim, wherein said groove (10) has the shape of a cylindrical surface sector having a radius substantially corresponding to the radius of said axial hole (9) .

5. Biopsy device (1) according to any preceding claim, wherein said cannula (12) has a diameter substantially corresponding to the diameter of said axial hole (9) .

6. Biopsy device according to any preceding claim, characterised in that it further comprises a further through axial hole (11) made in the tip (6) of said mandrel (5), said further through axial hole (11) being substantially aligned with said axial hole (9) and said groove (10) .

7. Biopsy device (1) according to claim 6, wherein said further through axial hole (11) has a diameter substantially corresponding to the diameter of said axial hole (9) .

8. Biopsy device (1) according to claim 6, or 1, wherein said cannula (12) is also insertible in said further through axial hole (11) .

9. Biopsy device (1) according to claim 8, wherein the distal end of said cannula (12) has a shape corresponding to the shape of the distal end of the tip (6) of the mandrel (5) .