Technical Field

The present invention relates to a perforating device for containers of medical, diagnostic and physiological fluids.

Background Art

With particular reference to the hospital sector, perforating devices, commonly called “spikes”, are known to be used to perforate the containers in order to facilitate the sampling of the fluid contained therein.

Compared with the use of ordinary injection syringes, such perforating devices are able to ensure greater precision and accuracy in the dosing and administration of substances and/or drugs, as well as to allow for greater safety and protection of the operator and patient, avoiding accidental contact with dangerous substances.

The perforating devices of known type usually have a substantially tubular main body. The main body comprises a through cavity that extends between a first opening and second opening arranged at either end of the body itself. The cavity defines a fluid flowing path inside the main body.

One end of the main body is provided with a tip adapted to perforate the container, while the other end comprises fastening means, usually of the Luer- lock type, configured to allow the perforating device to be coupled to a syringe. Usually, the perforating device is gripped by the operator at the main body. Since, generally, such devices are made small in size and with an extremely reduced diameter, the grip is very awkward and makes the perforating device difficult to use.

In addition, in the case of prolonged use, such devices require a lot of effort on the part of the operator to perforate the container, especially as a result of the high number of sampling.

Finally, these perforating devices appear susceptible to improvements in order to increase their convenience and ease of use.

Description of the Invention The main aim of the present invention is therefore to devise a perforating device which allows facilitating the sampling of fluids from containers, thereby facilitating the preparation of drugs by an operator.

Another object of the present invention is to devise a perforating device which can reduce the operator’s effort and fatigue in perforating the containers.

Another object of the present invention is to devise a perforating device which can overcome the aforementioned drawbacks of the prior art within the framework of a simple, rational, easy and effective to use as well as affordable solution.

The aforementioned objects are achieved by this perforating device for containers of medical, diagnostic and physiological fluids having the characteristics of claim 1.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a perforating device for containers of medical, diagnostic, and physiological fluids, illustrated by way of an indicative, yet non-limiting example, in the accompanying tables of drawings wherein:

Figure 1 is a perspective view of the perforating device in accordance with the present invention,

Figures 2 and 3 are side views of the perforating device in Figure 1,

Figure 4 is a side view of the perforating device in Figure 1 associated with a syringe and with a container.

Embodiments of the Invention

With particular reference to these figures, reference numeral 1 globally indicates a perforating device for containers of medical, diagnostic and physiological fluids.

In the example shown in the figures, the container C is a bottle closed by a closure element A, preferably of the type of a membrane. It cannot however be ruled out that the container may be of a different type, such as e.g. bags, flasks, vials and the like. The perforating device 1 is adapted to perforate the closure element A of the container C and is associable with, e.g., a syringe to enable a user to draw the fluid contained in the container C.

For this purpose, the perforating device 1 comprises a main hollow body 2 with an elongated conformation. That is, the main body 2 mainly extends along its own longitudinal direction.

Preferably, the main body 2 has a substantially tubular conformation. In other words, in cross section, the main body 2 has a substantially circular profile.

Conveniently, the main body 2 is provided with at least one fastening portion 3 which can be coupled to a syringe S and comprising a first opening 4, and a perforating portion 5 opposite the fastening portion 3 and comprising a second opening 6. In addition, the main body 2 comprises a passage duct 7 extending between the first opening 4 and the second opening 6 and adapted to allow the passage of a medical fluid along a direction of flow Vi. Preferably, the direction of flow Vi is substantially parallel to the direction of longitudinal development of the main body 2.

Preferably, the fastening portion 3 and the perforating portion 5 are made in a single monolithic body. It cannot however be ruled out that the fastening portion 3 and the perforating portion 5 may be two separate elements associated with each other.

Preferably, the duct 7 coincides with the cavity of the main body 2 and the openings 4, 6 are made in fluid- operated communication with such a cavity.

As can be seen from the figures, the perforating portion 5 has a substantially smaller transverse dimension than the transverse dimension of the fastening portion 3. In other words, the perforating portion 5 has a smaller diameter than the diameter of the fastening portion 3. In the present case, the main body 2 is tapered at the joining point between the fastening portion 3 and the perforating portion 5.

In addition, the perforating portion 5 is tapered at the second opening 6. This tapering conformation ends at the tip 5c where the second opening 6 is located. The tip 5c has a transverse direction which is inclined with respect to the direction of flow Vi in such a way as to allow perforating the closure element A of the container C.

Advantageously, the main body 2 has a handling portion 8 associated with the main body 2 and having a longitudinal development substantially transverse to the direction of flow Vi.

The handling portion 8 is configured to be gripped by a user in order to facilitate the use of the perforating device 1 , thus making perforation operations easier. Appropriately, the handling portion 8 comprises a first gripping element 9 and a second gripping element 10 associated with the main body 2. The first gripping element 9 and the second gripping element 10 are opposite each other. In particular, the first gripping element 9 and the second gripping element 10 are opposite each other with respect to the direction of flow Vi. These gripping elements 9, 10 allow the user to grasp and grip the perforating device 1 with the fingertips of their fingers, thus increasing the ergonomics of the perforating device 1.

Conveniently, the first gripping element 9 and the second gripping element 10 are arranged spaced apart from the main body 2. In this way, the handle of the perforating device 1 is displaced and detached with respect to the direction of flow Vi of the fluid inside the duct 7.

As can be observed from Figure 2, each of the gripping elements 9, 10 comprises a contact surface I la, 11b arranged substantially parallel to the direction of flow Vi. Specifically, the contact surfaces I la, 11b are arranged opposite each other with respect to the direction of flow Vi.

Furthermore, the contact surfaces I la, 11b are arranged substantially aligned with each other along a direction transverse to the direction of flow Vi. In other words, the contact surfaces I la, 11b are substantially axial- symmetrical with each other with respect to the direction of flow Vi.

Conveniently, the contact surfaces I la, 11b face outwards to the main body 2 of the perforating device 1.

As can be seen from Figure 3, each of the contact surfaces I la, 11b has a conformation that is substantially complementary to the fingertip of the user. This improves the ergonomics and comfort of the handle of the perforating device 1, making it easier to use even when the main body 2 has very small dimensions.

In the present case, the contact surfaces I la, 11b have a curvilinear profile. This profile is sized so as to fit the fingertip of the user.

In detail, each of the contact surfaces I la, 11b comprises a concavity 12a, 12b intended, in use, to abut against the fingertip of the user. As anticipated above, the concavities 12a, 12b are opposite the main body 2. In addition, the concavities 12a, 12b face outwards from the main body 2.

In other words, the concavities 12a, 12b are arranged with their bottom facing the main body 2.

As can be seen from the figures, the contact surfaces I la, 11b have, at least in a longitudinal section, a substantially circumferential arc profile. Such a circumferential arc has a predefined radius of curvature.

Conveniently, each contact surface I la, 11b has, in longitudinal section, a radius of curvature comprised between 20 mm and 150 mm, preferably 10 mm. Appropriately, the contact surfaces I la, 11b extend from a distal end with respect to the tip 5c to a proximal end to the tip 5c, diverging from each other with respect to the main body 2. The proximal end of the contact surfaces I la, 1 lb is substantially more spaced apart from the main body 2 than the distal end. In other words, with particular reference to Figure 2 wherein the contact surfaces I la, 11b are arranged opposite with respect to the main body 2 and the perforating portion 5 is arranged inferiorly to the fastening portion 3, the contact surfaces 1 la, 1 lb are arranged laterally and substantially tangent to the third and to the fourth quadrants, respectively, of a corresponding circumference having a radius equal to the radius of curvature of the respective contact surface 1 la, 1 lb. In one embodiment, the contact surfaces I la, 11b are arranged laterally and substantially tangent one to the third and to the second quadrant and the other to the fourth and to the first quadrant.

This configuration allows increasing the thrust force that is imposed by the user on the device during the perforation operation of the container C. In addition, conveniently, each contact surface I la, 11b has a length comprised between 7 mm and 20 mm, preferably 9.8 mm; a width comprised between 14 mm and 30 mm, preferably 18.2 mm.

In addition, the connecting element 13 has a length comprised between 19 mm and 36 mm, preferably 23.3 mm.

The connecting element 13 has a radius of curvature comprised between 12 mm and 20 mm, preferably 16.5 mm.

Conveniently, the handling portion 8 comprises at least one connecting element 13 of the gripping elements 9, 10 to the main body 2. The connecting element 13 extends transversely to the main body 2 between the gripping elements 9, 10. In detail, the connecting element 13 has a first stretch 13a positioned between the first gripping element 9 and the main body 2, and a second stretch 13b positioned between the main body 2 and the second gripping element 10.

Appropriately, the first gripping element 9 and the second gripping element 10 are arranged substantially transversely to the connecting element 13.

Preferably, the connecting element 13 and the main body 2 are in a single body piece. It cannot however be ruled out that the connecting element 13 can be separated from the main body 2 and associated with the latter by welding, fastening means or the like.

As shown in the figures, the connecting element 13 is arranged at the horizontal median axis passing through the main body 2.

Preferably, the connecting element 13 is arranged in the proximity of the joining point between the perforating portion 5 and the fastening portion 3.

Even more preferably, the connecting element 13 is joined to the main body 2 at the perforating portion 5 and is arranged close to the fastening portion 3.

Appropriately, the connecting element 13 has a curvilinear profile.

That is to say, as shown in Figure 1, the connecting element 13 has, in longitudinal section, a substantially circumferential arc profile.

This conformation allows the handle to be even more ergonomic, enabling the user to apply more force during the perforation phases.

In this case, the connecting element 13 defines a concavity 14 facing opposite with respect to the perforating portion 5. In other words, the concavity 14 faces the fastening portion 3.

Preferably, the connecting element 13 has a first portion 15 facing the perforating portion 5 and a second portion 16 facing the fastening portion 3. The first portion 15 has a curvilinear surface 15a substantially transverse to the direction of flow Vi.

Preferably, the curvilinear surface 15a is orthogonal to the direction of flow Vi. The second portion 16, on the other hand, is arranged substantially parallel to a plane passing through the direction of flow Vi. The second portion 16 is connected to the first portion 15 at the curvilinear surface 15a.

Appropriately, the perforating device 1 comprises at least one valve element, not shown in the figures, associated with the first opening 4 and adapted to allow the fluidic connection between the duct 7 and the syringe S. Conveniently, the valve element is configured to allow the fluid to flow only when the fastening portion 3 is fastened to the syringe S and to block the fluid to flow when the fastening portion 3 is separated from the syringe S.

Preferably, the valve element is of the type of a bidirectional valve.

It cannot however be ruled out that the valve element may be of the type of a one-way valve adapted to allow the fluid to flow into the duct from the second opening towards the first opening and to prevent it in the opposite direction.

Preferably, the valve element is made of a transparent plastic material with a medical silicone self-sealing system. The use of a transparent material allows the user to detect the fluid at any point in the channel.

In this case, the main body 2 is made at least partly of polycarbonate.

By means of such an expedient, a PVC-, DHEP- and Latex-free perforating device 1 can be made.

Conveniently, the fastening portion 3 comprises fastening means 17 configured to connect the main body 2 to the syringe S in a removable manner. In the present case, the fastening means 17 allow the first opening 4 to be arranged in fluidic communication with the syringe S.

For this purpose, preferably, the fastening means 17 are of the Luer-lock type. The Luer-lock connector makes the device 1 particularly adapted to be safely associated with any infusion device for medical use, and any instrument provided with a Luer-lock connector complementary thereto, such as syringes, one-way or two-way valves, etc. It cannot however be ruled out that the fastening means 17 may be of a different type, such as e.g. a bayonet type.

It has, in practice, been ascertained that the described invention achieves the intended objects and, in particular, the fact is emphasized that the perforating device according to the invention makes it possible to facilitate the sampling of fluids from containers, thus promoting the preparation of drugs by an operator.

In addition, the perforating device is capable of reducing the operator’s effort and fatigue in perforating the containers.