WO2014076648A1

WO2014076648A1 - Protection device for medical needles or catheters

Info

Publication number: WO2014076648A1
Application number: PCT/IB2013/060123
Authority: WO
Inventors: Marcello Dell'oca; Lorenzo Dell'oca
Original assignee: M.D.L. S.R.L.
Priority date: 2012-11-14
Filing date: 2013-11-14
Publication date: 2014-05-22
Also published as: ITMI20121930A1

Abstract

The protection device (1) for needles o catheters defines a passage for a needle or catheter (3) and comprises A) a casing (5), B) a leaf spring (9) and C) a spring retaining system (2). In the operating condition the more deformed leaf spring (9) allows the needle or catheter (3) to slide through it. In the blocking condition the released leaf spring (9) prevents the needle or catheter (3) from sliding through it. The device (1) is able to very securely hold smooth needles without radial recesses or projections.

Description

PROTECTION DEVICE FOR MEDICAL NEEDLES OR CATHETERS

Field of the invention

[1] The present invention concerns a protection device for needles, like for example biopsy needles or catheters for medical use, which avoids or decreases the risk of injury, for example with a needle or catheter with a sharp tip, after having used it.

State of the art

[2] In order to avoid injury with a needle or catheter ^* provided with a sharp tip, for example to take organic tissue samples for biopsy after having used it, there are currently known safety devices consisting of metallic springs that, after having used the needle, are slid with the fingers along the needle towards its tip, and when the tip is reached a leaf spring snaps across covering the sharp edges of the tip of the needle .

However, if the sides of the needle or catheter are smooth, there is nothing to prevent the safety devices from completely slipping off the needle, making them totally ineffective. The notches, holes, recesses or projections possibly made on the sides of the needle to prevent the safety spring from slipping off have various drawbacks: for example, they make it much more painful to insert the needle into the patient's body and extract it; moreover, they can easily become a receptacle for tumour cells and contribute to spreading them when the needle or catheter is extracted.

[3] A purpose of the present invention is to avoid the aforementioned drawbacks and in particular to provide a protection device that prevents or at least makes injury more difficult with a medical needle or catheter after having used it, which is more difficult to completely slip off the needle or catheter even if it has substantially smooth sides.

Summary of the invention

[4] Such a purpose is accomplished, in a first aspect of the invention, with a protection device for needles or catheters having the characteristics according to claim 1.

In a second aspect of the invention such a purpose is accomplished with a package having the characteristics according to claim 13.

[5] Further characteristics of the device are the object of the dependent claims.

The advantages that can be obtained with the present invention will become clearer to the man skilled in the art from the following detailed description of some example embodiments, not for limiting purposes, illustrated with reference to the following schematic figures.

List of figures

Figure 1 shows a first side view, partially in section according to the plane I- I, of a protection device for needles or catheters according to a first particular embodiment of the invention, in operating condition;

Figure 2 shows a second side view, partially in section according to the plane I-I, of the protection device of Figure 1 in a first blocking condition;

Figure 3 shows a third side view, partially in section according to the plane I-I, of the protection device of

Figure 1 in a second blocking condition;

Figure 4 shows a perspective view of the protection device of Figure 1, in the operating condition;

Figure 5 shows a fourth side view, partially in section according to the plane I-I, with a detail of the cross- through portions of the leaf spring of the protection device of Figure 1, in blocking condition;

Figure 6 shows a perspective view of the leaf spring of the protection device of Figure 1;

Figure 7 shows a perspective view of the inner component of the protection device of Figure 1;

Figure 8 shows a side view, partially in section according to a section plane passing through the axis of the needle, of a protection device for needles or catheters according to a second particular embodiment of the invention, in operating condition.

Detailed description

[6] Figures 1-7 relate to a protection device for medical needles or catheters, like for example needles for taking organic tissue samples for biopsies like soft tissues, bone marrow, muscles, bone, or needles for injections or drawing blood, according to a first embodiment of the invention. The needle or catheter 3 can for example be tubular and have a pointed or sharp front end. Such a protection device is indicated with reference numeral 1, defines a passage for a needle or catheter 3 and comprises a casing 5, a leaf spring 9 and a spring retaining system 2, where at least one out of the casing 5 and the leaf spring 9, in particular its holes 92, 94, form part of the passage for the needle .

Preferably, the casing 5 contains the leaf spring 9 and the spring retaining system 2 described hereafter.

The leaf spring 9 can, for example, be shaped like a 13060123

strip of suitable elastic material (Figure 4), for example spring steel of thickness possibly comprised between 0.1-0.7 mm; in non-deformed configuration the spring 9 can be planar or arc shaped.

The protection device 1 is arranged to pass from the operating condition to the blocking condition.

In the present description by "distal" and "proximal" an element is meant respectively farther from and closer to the user of the needle 3 and of the protection device 1 itself.

[7] According to an aspect of the invention:

-in the operating condition (Figure 1) the spring retaining system 2 holds the leaf spring 9 in a configuration of greater deformation, for example overall more arched, in which the leaf spring 9 allows the needle 3 to slide more easily longitudinally to itself with respect to the casing 5 and through at least a first 96 and a second portion 98, called cross- through portions of the leaf spring 9;

-in the blocking condition (Figure 2) the spring retaining system 2 has released the leaf spring 9 allowing it to take up a configuration of lesser deformation in which the leaf spring 9 prevents or however makes it more difficult for the needle or catheter 3 to slide longitudinally to itself relative to the casing 5 and through the at least two cross- through portions 96, 98 of the leaf spring 9.

[8] At each cross-through portion 96, 98 on the leaf spring 9 a through hole 92 and 94, respectively, is preferably formed, having dimensions such to allow the needle 3 to cross them when sliding without interference when the inclinations α₉₆ , «98 of the needle 3 with respect to the relative cross-through portion 96, 98 in the operating condition are sufficiently high.

For example, the through holes 92, 94 can have a diameter of a few hundredths of a millimetre more than the external diameter of the needle 3 , or a diameter greater by an amount preferably comprised between one thousandth and one ten- five hundredths of the external diameter of the needle 3, and more preferably between one thousandth and five hundredths of the external diameter of the needle 3.

[9] As shown in Figure 4, the angles of inclination a₉₆, a₉₈ , a' _{96 /} a'₉₈ are measured from the axis AX of the needle 3.

Advantageously, the protection device 1 is provided with a block-prevention system 4 that, in the blocking condition, prevents the inclination of the needle 3 relative to the first 96 or second cross-through portion 98 from decreasing below a predetermined minimum threshold a₉₆MiN_/ thus reducing the inclination a₉₈ of the needle 3 at the second 98 or first cross- through portion 96, respectively.

[10] As shown in Figures 1, 2, the protection device 1 can comprise a mechanical stop 40 arranged to abut against the sides of the leaf spring 9^■ at the first 96 or second cross-through portion 98, for example depending on whether the needle 3 is pulled back or pushed forward relative to the casing 5; in particular, the mechanical stop can for example be in the form of a block or projection shaped like a parallelepiped against which the leaf spring 9 can rest close to an end thereof (Figure 2) . Preferably the block or projection 40 extends, transversally to the needle 3, at least for the entire width of the leaf spring 9 and in any case it extends in the concavity of the arc formed by the spring 9.

The mechanical stop 40 can possibly constitute or form part of the block-prevention system 4.

[11] Preferably, the leaf spring 9 extends along the proximal/distal direction and is provided with a distal end, situated at or close to the first cross-through portion 96, and with a proximal end, situated at or close to the first cross-through portion 98, and the spring retaining system 2 comprises a first 200 and a second locking zone 201 arranged for hooking respectively the proximal and distal ends of the spring 9 in the operating condition and releasing the proximal and distal ends of the spring 9 in the blocking condition (Figures 1, 2) .

The first 200 and second locking zone 201 can be two mechanical stops or hooking teeth formed on a locking arm 7 housed in the casing 5.

The locking arm 7 is preferably integral with a wall of the casing 5 and, for this purpose, it can for example form a single and integral piece with the latter or form part of an internal component 10 (Figures 1, 2, 5) . The locking arm 7 can fix to the casing 5 or to the internal component 10 with a fitting or with a hinge 77, preferably elastic.

[12] The locking arm 7 preferably comprises a first portion 72 that extends longitudinally to the needle 3 and a second portion 74, which extends transversally to the needle 3 and is fixed to the distal end of the first portion 72. In the second portion a second through opening 70 is formed. As well as the second through opening 70 the aforementioned passage for the needle 3 through the device 1 can comprise two openings 50, 97 formed on the respective distal and proximal walls of the casing 5. The through openings 50, 70 and 97 have a shape and size such as to allow the needle 3 to cross them and slide freely through them at least in the operating condition.

The casing 5, the locking arm 7 and the internal component 10 can be made from plastic material, like for example polypropylene or acetalic resin, and they can for example be obtained by injection moulding.

[13] Advantageously, the locking arm 7 is moulded in the configuration that it must take up in the blocking condition, so that the second through opening 70 is moved with respect for example to the opening 50 so as to close the aforementioned passage for the needle 3 and, when the protection device 1 is assembled in the operating condition, the arm 7 must be deformed elastically; the arm 7 is then kept in the preloaded condition of Figure 1 by the needle 3 fitted in the through openings 50 and 70.

[14] An example of operation and use of the protection device 1 is now described.

The needle or catheter 3, for example a needle for taking soft tissue or bone samples, is preferably supplied in a sealed single-use package with the protection device 1 inserted over the tubular body of the needle itself closest to the proximal end of the needle itself (Figure 1) . After having carried out the biopsy, the safety pin 11 is removed and the needle or catheter 3 is withdrawn upwards until its tip does not enter into the casing 5, withdrawing from the through opening 50 of the casing 5 and from the second through opening 70 (Figure 2) .

[15] By doing so, the locking arm 7 is freed and thanks to its elastic return it rotates, in the anti-clockwise direction, with reference to Figures 1, 2, about the elastic hinge 77 so as to:

-stagger apart the two openings 50, 70, close the passage of the needle 3 and prevent the latter from coming back out again from the opening 50; and

-free the spring 9 releasing its ends from the locking zones 200, 201.

The spring 9 tends to go back into an elastically less deformed and curved configuration, tending to reduce the angles of inclination a₉₆ , a₉₈ of the cross-through portions 96, 98.

[16] If the user pulls the needle 3 back (arrow Fl) , the needle 3 tends to pull the spring 9 back with it, in particular pulling back the end and the proximal portion 98 and resting the distal portion 96 against the block 40 of the possible block-prevention system 4 ; the latter prevents the inclination a₉₆ from falling below the predetermined minimum value preventing the distal cross-through portion 96 and the hole 92 from gripping on the needle 3, instead promoting the reduction of the inclination a₉₈ of the proximal cross- through portion 98 relative to the needle 3. Thanks to the reduced clearances with the needle 3, the distal through hole 94 grips easily to the needle 3 locking it by friction, possibly cutting its surface and in any case preventing it from sliding further back. Extending in the concavity of the arc formed by the spring 9, the block 40 holds the spring 9 preventing it from sliding back. In order to promote the grip of the spring 9 on the sides of the needle 3, advantageously the edges of the through holes 92, 94 are as sharp as possible.

[17] Similarly, if the needle 3 is pushed forwards (arrow F2) the proximal portion 98 abuts against the proximal end of the block 40 preventing the hole 98 from gripping onto the needle 3, instead making the distal hole 96 grip onto it and preventing the further sliding forward of the needle, said sliding also being prevented by the second portion 74 of the arm 7 that closes the opening 50 of the casing 5.

The greater the force with which the user pulls the needle back or pushes it forward, the greater the force with which the spring 3 blocks the sliding of the needle back or forwards, respectively. The sharp tip of the needle 3 therefore stays securely enclosed in the casing 5 without being able to come out.

[18] From the above description it can clearly be seen how the protection device 1 is able to very effectively block the tip of the needle in the casing 5, preventing a user from accidentally being injured, despite the needle having completely smooth cylindrical sides, in particular without radial recesses and projections like, for example, teeth, incisions, hollows or undercuts, eliminating their relative drawbacks.

The device 1 also lends itself to being made with a very simple mechanical construction and produced with relatively cost-effective technologies. Since it has quite a simple shape, and for example without S-shaped curvatures, the spring 9 does not require particularly precise machining technologies and can have variable elastic characteristics within relatively wide tolerances .

[19] The example embodiments described above can undergo various modifications and variations without departing from the scope of protection of the present invention. For example, when the needle is withdrawn from the through opening 70, the arm 7 can be moved not only exploiting the elastic return of the arm 7 itself and/or its joining zone to the internal component 10 or to the casing 5, but also that of a second spring 12 that pushes directly on the distal free end of the arm 7 (Figure 8) ; the second spring 12 can for example be made from steel or from the thick plastic material from which the casing 5 and/or the arm 7 is made.

Moreover, all of the details can be replaced by technically equivalent elements. For example, the materials used, as well as the sizes, can be whatever depending on the technical requirements . It should be understood that an expression of the type "A comprises B, C, D" or "A is formed from B, C, D" also comprises and describes the particular case in which "A consists of B, C, D" . The examples and lists of possible variants of the present application should be taken as non-exhaustive lists.

Claims

1) Protection device (1) for medical needles or catheters forming a passage for a needle or catheter (3) and arranged to switch from an operating condition to a second blocking condition in which the passage for the needle (50, 70, 92) is substantially closed preventing the needle or catheter (3) from passing from one side of the protection device (1) to the other, the protection device (1) comprising:

-a casing (5) ;

-a leaf spring (9) ;

-a spring retaining system (2) ;

and in which:

-in the operating condition the spring retaining system (2) keeps the leaf spring (9) in a configuration of greater deformation in which the leaf spring (9) allows the needle or catheter (3) to slide more easily longitudinally to itself relative to the casing (5) and through at least a first (96) and a second portion (98) of the leaf spring (9), named cross-through portions;

-in the blocking condition the spring retaining system (2) has released the leaf spring (9) allowing it to assume a configuration of lesser deformation in which the leaf spring (9) prevents or however makes it more difficult for the needle or catheter (3) to slide longitudinally to itself relative to the casing (5) and through the at least two cross-through portions of the leaf spring (96, 98) .

2) Device (1) according to claim 1, wherein in the blocking condition the inclination (a'_{96 >} & ' 98 ) of the needle (3) relative to one between the first (96) and the second cross-through portion (98) is substantially less than the smallest inclination (α₉₆ , a₉₈) of the needle (3) relative to the first (96) and to the second cross- through portion (98) in the operating condition, so that in the blocking condition one between the first (96) and the second cross-through portion (98) exerts a greater friction against the sides of the needle (3) in comparison with the operating condition.

3) Device (1) according to claim 1, comprising a block- prevention system (4) which in the blocking condition prevents the inclination of the needle ( '_9ε , α'₉₈ ) relative to the first (96) or to · the second cross- through portion (98) from decreasing below a predetermined minimum threshold, so as to decrease the inclination of the needle at one only between the first (96) and the second cross-through portion (98) .

4) Device (1) according to claim 3, wherein the block- prevention system (4) comprises a mechanical stop (40) arranged to abut against the sides of the leaf spring (9) at the first (96) or second cross-through portion (98) .

5) Device (1) according to claim 1, comprising a mechanical stop (40) arranged to abut against the sides of the leaf spring (9) at the first (96) or second cross-through portion (98) .

6) Device (1) according to claim 1, wherein the leaf spring (9) extends along the proximal/distal direction and is provided with a proximal end and a distal end, and the spring retaining system (2) comprises a first (200) and a second locking zone (201) arranged for engaging respectively the proximal and distal ends of the spring (9) in the operating condition and releasing the proximal and distal ends of the spring (9) in the blocking condition.

7) Device (1) according to claim 6, comprising a locking arm (7) on which the first (200) and the second locking zone (201) are arranged and the locking arm (7) is arranged for disengaging the proximal and distal ends of the spring (9) making a translation and/or rotation movement relative to the casing (5) .

8) Device (1), according to claim 6, comprising elastic release means (77; 12) arranged for releasing the proximal and distal ends of the spring (9) from the first (200) and the second locking zone (201) passing from the operating condition to the blocking condition.

9) Device according to claim 8, wherein the locking arm (7) is integral with the casing (5) and the elastic release means comprise the locking arm (7) and/or the portion (77) in which the arm (7) fixes to the casing (5) .

10) Device (1) according to claim 1, wherein in the operating condition the passage for the needle (50, 70, 92) is substantially open and through it the needle or catheter (3) can cross from side to side the protection device (1) itself.

11) Device (1) according to claim 1, wherein in the blocking condition the passage for the needle (50, 70, 92) is substantially closed preventing the needle or catheter (3) from crossing the protection device (1) from one side to the other.

12) Device (1) according to claim 1, wherein the locking arm (7). is arranged for closing the passage of the needle (50, 70, 92) passing from the operating condition to the blocking condition.

13) Package containing: -a medical needle or catheter (3) comprising a tubular cannula designed to be inserted in the body of a patient; and

-a protection device (1) having the features according to one or more preceding claims and fitted on the needle cannula or catheter (3) .