WO2016083652A1

WO2016083652A1 - Device for catheterisation

Info

Publication number: WO2016083652A1
Application number: PCT/ES2015/070858
Authority: WO
Inventors: Antonio BÁRCENAS VILLEGAS; Jesús Joaquín JIMÉNEZ ZARANTÓN
Original assignee: Agencia Pública Empresarial Sanitaria Bajo Guadalquivir; Ingeniería Médica, S.L.
Priority date: 2014-11-26
Filing date: 2015-11-26
Publication date: 2016-06-02
Also published as: ES1134880Y; ES1134880U

Abstract

The invention relates to a device (1) for catheterisation by means of a catheter (2) containing an extractable guiding needle (3), characterised in that it comprises a reservoir (5) for physiological serum, the distal end of which is connected to the extractable needle (3) and the proximal end of which comprises a plunger (7). Furthermore, a particularly preferred embodiment of the device (1) comprises an automatic actuating means designed to actuate the plunger (7) in the distal direction so as to drive the physiological serum. The automatic actuating means can be electrical, hydraulic, pneumatic, mechanical or a combination thereof.

Description

DEVICE FOR CATHETERATION DESCRIPTION OBJECT OF THE INVENTION

The present invention belongs to the medical field, and more specifically to the nursing procedures related to peripheral venous catheterization. The object of the present invention is a new catheterization device comprising a reservoir for physiological serum connectable to a conventional catheterization device with the purpose of assisting in the channeling in patients with irregular and little rectilinear venous accesses. BACKGROUND OF THE INVENTION

Peripheral venous catheterization serves to obtain peripheral venous access for medication administration, blood sample collection, suerotherapy and parenteral feeding. The technique consists mainly of introducing a needle (trocar) that guides the catheter through a puncture in the patient's vein, forming approximately 30 ° with the skin. Then, after immobilizing the catheter by means of adhesive tape or the like, the needle is removed and the catheter is connected to a conduit connected to the medium to be introduced (serum, medication, etc.), or to a device adapted for extraction of blood samples.

A common drawback of this technique occurs when the patient has irregular and poorly rectilinear venous paths that prevent the needle serving as a guide for the catheter can progress properly along the same. Indeed, ideally the introduction of the needle that serves as a guide for the catheter is simple in a rectilinear vein and without curvatures, but when its trajectory has irregular curves, it is easy for any of these curves to produce unwanted perforations of the vein . The technique used in these cases, which are quite common in elderly patients, is fundamentally the following. First, the needle is inserted into the patient's vein only one small distance Next, the needle is removed and a low flow suerotherapy system is connected to the catheter. The purpose is for the flow itself to open its way into the vein as the nursing professional slowly introduces the catheter. Once the catheter has been completely inserted into the patient's vein, the suerotherapy system is disconnected and the connected duct is connected to the medium to be introduced (serum, medication, etc.).

It is clear to note that this procedure has numerous drawbacks. In the first place, the connection of the serum system is carried out when only a small portion of the catheter has been introduced into the vein, so that it may occur inadvertently out of the vein, thus causing unnecessary additional punctures. In addition, vein perforations may occur during catheter introduction, as well as unwanted drug extravasations.

Therefore, there is still a need in the art for improved devices that allow this procedure to be carried out in a more efficient manner, that is, so that without having to move the hands towards another device far away from the catheterization technique, it is possible to channel this type of "complicated" venous access.

DESCRIPTION OF THE INVENTION

As mentioned, a conventional catheterization device comprises a catheter in which there is a removable guide trocar or needle, the base of the guide needle being connectable to a sotherapy therapy system or the like. The inventors of the present application have designed a novel device for catheterization that solves the above problems thanks to the fact that it is formed by a small reservoir for physiological serum provided with a plunger and that is connectable to said removable catheter guide needle. Thus, in a manner similar to that used in the currently known technique, nurses can connect this device to the base of the guide needle of the conventional catheterization device to propel the serum through the catheter as it is introduced into the vein, thus avoiding the need to connect and disconnect an external therapy system. As a consequence, the appalling process of connecting a suerotherapy system is avoided when the catheter has not yet been fixed, with the inconvenience that this entails. In addition, the use of this device makes it possible to manipulate and drive the catheter introduced into the patient with greater certainty because the device of the invention is much less bulky than a suerotherapy system. Therefore, in a first aspect of the invention the catheterization device is formed by a reservoir for physiological serum whose distal end is connectable to the proximal end of the removable guide needle and whose proximal end comprises a plunger. In this document, the term "reservoir for physiological serum" refers to a reservoir or reservoir configured to store a sufficient volume of physiological serum to facilitate the introduction of the needle into the blood vessel in question. It has been found that a suitable volume for performing this procedure is between 0.5 ml and 3.0 ml, more preferably between 1.0 ml and 2.5 ml, and even more preferably approximately 2 ml. The loading of this reservoir can be done by healthcare professionals simply by pulling the plunger proximally in the same way as in a conventional syringe.

In this document, the expression "connectable to the proximal end of the removable needle" indicates that the distal end of the reservoir is configured so that it can be coupled to the proximal end of a removable guide needle conventionally used for catheterization. For example, the distal end of the reservoir may have a Luer adapter or the like. The operation of this device would be fundamentally the following. The nurse connects the device of the invention to the base of the removable guide wire of the catheter. Next, insert a small portion of said removable guide needle into the patient's vein. Then, while removing the needle from the catheter, the catheter is introduced into the patient's vein and injecting the physiological serum from the reservoir by manually operating the piston distally. Obviously, it is understood that the physiological serum contained in this reservoir is sterile and suitable for intravenous infusion. The flow of physiological serum passes through the needle until it reaches the catheter, where it continues until it finally comes out through the distal end of the catheter to make its way through the vein and avoid unwanted punctures. Once the catheter is completely inserted into the vein and the needle has been completely removed from the catheter, a conduit for the administration of the medium in question is connected to the catheter. In a particularly preferred embodiment, the device of the invention further comprises an automatic actuating means configured to drive the plunger distally for the purpose of driving the physiological serum through the needle. In this context, the automatic actuation means can be any element capable of operating the piston distally to proceed with the discharge and discharge of the physiological serum stored in the reservoir for physiological serum. For example, the automatic actuating means may be of the mechanical, hydraulic, pneumatic, electric type, or a combination of the above.

In addition, preferably the automatic actuation means is configured to drive the plunger progressively for a predetermined period of time. For example, the automatic actuating means may be arranged so that the plunger takes about 5-10 seconds to travel throughout the reservoir.

Thus, from the moment the healthcare professional activates said actuation means, he has those 5-10 seconds to insert the catheter into the patient's blood vessel knowing that during all this time the plunger will be driving a continuous flow of physiological serum. through the catheter to straighten the vessel in question and facilitate insertion.

In a particularly preferred embodiment of the invention the automatic actuation means is a spring disposed between the plunger and the reservoir for physiological serum. In this embodiment, the device will further preferably comprise a trigger element configured to lock the plunger in its most distal position. The trigger element can be configured in different ways known in the art, for example by means of a small hook connected between the plunger and the reservoir for physiological serum that is released by pressing a button. Thus, once a small portion of the removable guide wire has been inserted into the patient's vein, the nurse only has to release the spring by acting on the trigger element. The force of the spring is thus released, which drives the plunger distally causing the physiological serum to exit through the distal end of the removable needle and thus creating a serum outflow that effects a force similar to a pressure wave opens the vein.

The spring can be configured in different ways as long as it allows the described functions to be carried out. For example, the spring may be a compression spring having a distal end connected to a distal plate of the plunger and a proximal end connected to a proximal base of the reservoir for physiological serum. Alternatively, the spring may be a tension spring having a distal end connected to a proximal base of the physiological serum reservoir and a proximal end connected to a proximal plunger button. Both configurations will be described in greater detail in relation to the figures. In either case, the spring elastic constant can be determined so that the plunger takes a predetermined time to travel throughout the reservoir.

In another preferred embodiment of the invention, a piston rod comprises a rupture zone that allows, once the physiological delivery process has been carried out, to separate or break the most proximal part thereof. This feature allows the healthcare professional to discard a posterior portion of the plunger so that it occupies a smaller volume and thus facilitate the handling of the assembly. In another preferred embodiment of the invention the device is disposable.

In a further preferred embodiment of the invention the device is reusable.

In yet another preferred embodiment of the invention the device is sterile.

In yet another preferred embodiment of the invention the device is non-sterile.

In a particularly preferred embodiment of the invention, the device is connected to the removable needle located inside the catheter. That is, it is a configuration in which the device is provided with the reservoir already attached to the removable guide wire of a conventional catheterization device. This avoids the need for the healthcare professional to make the connection between a reservoir for physiological serum and needle. Catheterization devices frequently have a blood reservoir at the proximal end of the needle. In this context, the blood reservoir refers to a cavity capable of housing a small amount of blood, although it is not necessarily a reservoir designed specifically for the extraction or storage of blood from the patient. Therefore, in a preferred embodiment the device of the invention further comprises a blood reservoir disposed between the proximal end of the removable needle and the distal end of the physiological serum reservoir. In addition, preferably, the volume of the blood reservoir and the volume of the physiological serum reservoir are approximately equal to avoid transporting from one to another by gradient. That is, preferably the volume of the blood reservoir is between 0.5 ml and 3.0 ml, more preferably between 1.0 ml and 2.5 ml, and even more preferably approximately 2 ml.

Alternatively, both the physiological serum reservoir and the blood reservoir could have the following volumes. The reservoir for physiological serum could have a volume between 0.2 ml and 0.8 ml, more specifically between 0.4 ml and 0.6 ml, and more specifically approximately 0.5 ml. The blood reservoir could have a volume between 0.2 ml and 0.8 ml, more specifically between 0.4 ml and 0.6 ml, and more specifically approximately 0.5 ml. Even more preferably, the catheterization device of the present invention further comprises a filter disposed between the proximal end of the blood reservoir and the distal end of the reservoir for physiological serum.

A second aspect of the present invention is directed to a set of parts for catheterization comprising: a device as described above; and a catheter provided with a removable guide wire.

BRIEF DESCRIPTION OF THE FIGURES Fig. 1 shows a conventional catheterization device formed by a catheter in which a removable guide needle is arranged.

Figs. 2a and 2b show two embodiments of a catheterization device according to the present invention respectively. Figs. 3a-3f schematically show an example of use of the device of the invention.

Figs. 4a and 4b show another example of a catheterization device provided with a compression spring.

Figs. 5a and 5b show another example of a catheterization device provided with a tension spring. PREFERRED EMBODIMENT OF THE INVENTION

An example of peripheral venous catheterization device (1) according to the present invention is described below with reference to figures where the main parts that comprise it are appreciated.

Fig. 1 shows an example of a conventional catheterization device formed essentially by a catheter (2) through which a removable guide needle (3) runs. The set has a base configured for connection to a sueroterapia system (not shown). In addition, in this example the base of the needle also includes an area with a larger section that constitutes the so-called blood reservoir (4).

Fig. 2a shows a first configuration of the device (1) of the present invention. This device (1) essentially comprises a reservoir (5) for physiological serum having a plunger (7) at its proximal end and whose distal end is connectable to the base of the removable needle (3) mentioned above. Therefore, to use this device (1), the healthcare professional must attach it to a conventional catheterization device as shown in Fig. 1. Fig. 2b shows a second configuration of the device (1) of the present invention presented already attached to the conventional catheterization device of Fig. 1. In this example, the blood reservoir (4) located at the proximal end of the removable guide wire (3) is connected, in this case through a filter (6 ), to a reservoir (5) of physiological serum. This physiological serum reservoir (5) has at its proximal end a plunger (7) that will allow the serum to be distally promoted physiological charged inside the reservoir (5). With this second configuration, the healthcare professional can use the device (1) directly without having to make any previous connection. As discussed earlier in this document, in any of the two configurations described in Figs. 2a and 2b the volume of the reservoir (5) of physiological serum is preferably between 0.5 and 3.0 ml, more preferably between 1.0 and 2.5 ml, although in this particular example the volume is 2, 0 mi. As for the volume of the blood reservoir (4) (in the second configuration), it is preferably between 0.5 and 3.0 ml, more preferably between 1.0 and 2.5 ml, although in this particular example the volume It is about 2.0 mi. Either of the two configurations shown in Figs. 2a and 2b can be supplied with the reservoir (5) of empty physiological serum for the medical professional to load on its own, or with the reservoir (5) of pre-filled physiological serum.

The operation of this device (1) is fundamentally the following. In the case of the first device configuration (1) shown in Fig. 2a, first the medical professional makes the connection with the conventional catheterization device shown in Fig. 1. This first step is represented in Fig. 3rd. Next, as shown in Fig. 3b, the nurse inserts a small portion of the end of the catheter (2) and the needle (3) into the patient's vein. Then, from Fig. 3c, continue inserting the catheter (2) into the vein while removing the needle (3) and manually pressing the plunger (7) distally. The effect, as shown in Fig. 3d, is that the physiological serum stored in the reservoir (5) is gradually pushed through the needle (3) and exits the distal end of the catheter (2), creating a wave pressure that facilitates the introduction of the catheter (3) into the vein. This process ends in Fig. 3e, where only the distal end of the needle (3) continues inside the catheter (2). Immediately afterwards, as seen in Fig. 3f, the needle (3) ends up completely exiting the catheter (2), and with it the blood reservoirs (4) and physiological serum (5). The catheter (2) is ready for coupling to a conduit for administration to the patient of medication, blood extraction, parenteral feeding, or others.

Figs. 4a and 4b show another example of the first configuration of the device (1) of the invention which is provided with a compression spring (8) configured for push the plunger (7) distally. Specifically, the spring (8) is connected between the proximal side of the distal plate (7d) of the plunger (7) and the distal side of the proximal base (5p) of the reservoir (5) for physiological serum. That is, the spring (8) is located inside the proximal section of the reservoir (5), enclosed between the distal plate (7d) of the plunger (7) and the proximal base (5p) of the reservoir (5). In this context, the term "connected" not only includes the possibility that the spring (8) is physically attached to the distal plate (7d) and the thin proximal base (5p) which, being a spring (8) that It works with compression, it can simply be supported by them. In the position shown in Fig. 4a, the spring (8) is compressed and therefore exerts a force (F) on the plunger (7) distally. Preferably, a locking element (not shown in the figures) holds the plunger (7) to prevent it from moving distally. Fig. 4b shows the final state once the nurse has operated the locking element to release the plunger (7) and the spring (8) has driven said plunger (7) distally, thus causing the output of the physiological serum lodged in the reservoir (5).

Figs. 5a and 5b show a further example of the device (1) of the invention provided this time with a tension spring (8). The spring (8) has a distal end connected to the proximal side of the proximal base (5p) of the reservoir (5) and a proximal end connected to the distal side of the proximal push button (7p) of the plunger (7). Unlike in the previous example, the term "connected" here implies a physical connection, since the force exerted by the spring (8) is tensile. In the position shown in Fig. 5a, the spring (8) is extended beyond its natural position and therefore exerts a force (F) on the plunger (7) distally. Under these conditions, a locking element (not shown) similar to that described above can be used to prevent the plunger (7) from moving distally until necessary. Fig. 5b shows the final state after the nurse has operated the locking element to release the plunger (7) and the spring (8) has driven said plunger (7) distally, causing the serum to escape physiological lodged in the reservoir.

Claims

1. Device (1) for catheterization by means of a catheter (2) inside which there is a removable guide needle (3), characterized in that it comprises a reservoir (5) for physiological serum whose distal end is connectable to the removable needle (3) and whose proximal end comprises a plunger (7).

2. Device (1) according to claim 1, further comprising an automatic actuating means configured to drive the plunger (7) distally for the purpose of driving the physiological serum.

3. Device (1) according to claim 2, wherein the automatic actuating means is mechanical, hydraulic, pneumatic, electric, or any combination of the foregoing.

4. Device (1) according to claim 3, wherein the automatic actuation means is a spring (4) disposed between the plunger (7) and the reservoir (5) for physiological serum.

5. Device (1) according to claim 4, wherein the spring (8) is a compression spring having a distal end connected to a distal plate (7d) of the plunger (7) and a proximal end connected to a base proximal (5p) of the reservoir (5).

Device (1) according to claim 4, wherein the spring (8) is a tension spring having a distal end connected to a proximal base (5p) of the reservoir (5) and a proximal end connected to a push button proximal (7p) of the plunger (7).

7. Device (1) according to any of claims 2-6, wherein the automatic actuating means is configured to drive the piston (7) progressively for a predetermined period of time.

8. Device (1) according to any of claims 2-7, further comprising a trigger element (9) configured to lock the plunger (7) in its more distal position.

9. Device (1) according to any of the preceding claims, wherein the reservoir (5) for physiological serum has a volume of between 0.5 ml and 3.0 ml.

10. Device (1) according to claim 9, wherein the reservoir (5) for physiological serum has a volume between 1.0 ml and 2.5 ml.

1 Device (1) according to claim 10, wherein the reservoir (5) of physiological serum has a volume of approximately 2.0 ml.

12. Device (1) according to any of the preceding claims, wherein a piston rod (7) comprises a breakage zone.

13. Device (1) according to any of the preceding claims, which is disposable.

14. Device (1) according to any of the preceding claims, which is reusable.

15. Device (1) according to any of the preceding claims, which is sterile.

16. Device (1) according to any of the preceding claims, which is non-sterile.

17. Device (1) according to any of the preceding claims, which is connected to the removable needle (3) located inside the catheter (2).

18. Catheterization device (1) according to claim 17, further comprising a blood reservoir (4) disposed between the proximal end of the removable needle (3) and the distal end of the reservoir (5) for physiological serum.

19. Catheterization device (1) according to claim 18, further comprising a filter (6) disposed between the proximal end of the reservoir (4) blood and the distal end of the reservoir (5) for physiological serum.

20. Set of parts for catheterization, characterized in that it comprises: - a device (1) according to any one of claims 1-16; and - a catheter (2) provided with a removable guide needle (3).