WO2013087962A1

WO2013087962A1 - Closed device for filling drip chambers in cytostatic delivery devices, and safety device and filling system including same

Info

Publication number: WO2013087962A1
Application number: PCT/ES2012/070861
Authority: WO
Inventors: Antonio Gonzalez Gonzalez
Original assignee: Antonio Gonzalez Gonzalez
Priority date: 2011-12-12
Filing date: 2012-12-12
Publication date: 2013-06-20
Also published as: ES1076535U; ES1076535Y

Abstract

The invention relates to a closed device for filling the drip chamber of safety devices used for the delivery of cytostatics and connected to a pump, and to the safety device and the system for filling the drip chamber of the safety device. More specifically, the invention relates to an apparatus, device and system for safely filling the drip chamber while cleaning the safety and/or universal device of the remains of the cytostatic drugs delivered and for safely extracting the air that can be introduced into the safety device during the delivery of cytostatic drugs, including a connection to a pump, and to patients with cancer.

Description

Closed device for filling drip chambers in cytostatic management equipment, safety equipment and filling system that integrates them.

OBJECT OF THE INVENTION

The present invention, closed device for filling the drip chamber of the safety equipment for the administration of cytostatics with pump connection, safety equipment and filling system of the drip chamber of safety equipment, refers to a device, equipment and system intended to safely fill the drip chamber by cleaning the safety and / or universal equipment of the remnants of cytostatic drugs administered, and also safely extract the air that can be introduced inside the equipment Safety during administration of cytostatic drugs, with pump connection, to cancer patients.

BACKGROUND OF THE INVENTION

Safety equipment for administration of cytostatics with pump connection with two or more integrated connection paths, which are referred to in the present invention as safety equipment, are currently the most commonly used for administering said drugs, although other equipment that is used is also used. They call "universal."

Both safety equipment and universal equipment maintain a similar design or structure, and both administer cytostatic drugs connected to an infusion pump that may have different characteristics. Said infusion pumps work with a drip chamber, said drip chamber being able to incorporate a drop sensor that detects the absence of drops at the end of the cytostatic drug, or a ball in the drip chamber that descends when the cytostatic drug is terminated, occluding the base of the chamber and stopping the pump ..

On the other hand, structurally, both safety equipment and universal equipment have: a punch punch suitable for connecting the clean serum supply container; a main clamp closure followed by as many access safety connections without a slip / luer-lock needle as necessary; a drip chamber; a connection to the pump and a tubing or tube provided in the distal end of connection with hydrophobic and antibacterial protector that allows purging. After the pump connection, the pump is placed and after this the patient.

The container containing the cytostatic drug is connected to the safety equipment through a secondary system or equipment provided with a piercing punch; a flexible extension tube without instant folding memory with integrated connector for needleless access; a clamp type closure; and at its distal end a slip / luer-lock type connection with hydrophobic protector and with a protective cap through which it is connected to the safety equipment, specifically one or more secondary equipment is connected, to connect one or more cytostatic drugs to the equipment security through the access safety connections without needle type slip / luer-lock arranged in the safety equipment.

Both safety equipment and universal equipment must be purged with serum, a purge that must be carried out at the beginning of each drug treatment, so that the entire tubing, or tube, is left without air and must remain in the drip chamber the recommended filling level for each safety and / or universal equipment. Once the safety equipment has been purged, it is connected to the pump, to the patient and the secondary system or equipment with the drugs is connected to the safety equipment.

The drug administration procedure is done by closing the main clamp of the safety or universal equipment and opening the clamp of the secondary equipment or system containing the cytostatic drug. When the drug is finished, the infusion is interrupted, this interruption is carried out by the pump acoustically warning the administrative personnel, and said personnel will close the clamp of the secondary system of the administered medication and open the main clamp of the safety or universal equipment that owns the serum, with this and by dragging complete the administration of the entire dose to the patient, since between the drip chamber of the safety team and the patient is a volume of drug that needs to be administered, and, once the drug, the serum will wash the entire safety or universal equipment and the patient's vein. Once the washing is finished, the equipment is prepared to administer the next drug, since the mixture of cytostatic drugs is not usually compatible since they can react with each other.

Once the wash is finished, the main clamp of the safety or universal equipment will be closed and the clamp of the secondary system containing the following drug will be opened. After administration of the second drug, It will proceed according to the procedure described and it will be repeated until all the drugs prescribed in the treatment are administered. After the infusion of the last drug, the final wash will be performed with a high volume, not less than 100 ml of serum, to ensure that both the safety equipment and the patient's vein are completely clean of drugs, avoiding exposure risks of handling personnel at the time of disconnection of the safety or universal equipment until its deposit in the appropriate container, since these drugs react easily with the air generating a cytostatic vapor that can have adverse effects.

In the operating mechanics described above there are two mechanisms in the drip chamber, already mentioned, by means of which the pumps detect the end of the infused drug. A first mechanism comprises a drop sensor in the drip chamber that detects the absence of drip when the medication ends, preventing air from entering the safety or universal equipment, and which we will call type A, and another mechanism comprising a ball located in the drip chamber that descends to its base occluding it and also preventing air from entering the safety or universal equipment, and which we will call type B.

The disadvantage of the type A mechanism is that a drop in the level of filling of the drip chamber can occur for multiple reasons requiring refilling of it. One of the reasons is that at the end of the drug and, since the sensor detects the absence of drops stopping the administration, a slight period of time elapses and during this, when no drug is left, air is introduced into the drip chamber, descending its level. This inconvenience is exacerbated by the majority of cancer treatments based on the so-called polychemotherapy schemes, that is, that a patient is given several cytostatic drugs consecutively, which will result in the end of each drug. decrease in the level of filling of the drip chamber, being able to lower so much the level that it was necessary to fill the drip chamber to avoid the entry of air into the safety or universal equipment; that is to say, the drip chamber must be filled to prevent the entry of air into the equipment, since this would imply the need to purge it or remove it so that the patient is not introduced, with the added disadvantage that, at present, no there is a safe technique to extract the introduced air. Another reason why it would be necessary to refill the drip chamber, may be due to any technical problem either in the drop sensor or the pump itself. In summary, any of the reasons for a decrease in the level of drip chamber filling will require filling it to prevent air from entering the safety or universal equipment.

The mechanism called type B, which uses a ball located in the drip chamber that descends at the end of the drug by occluding the base of the drip chamber of the safety or universal equipment stopping the pump, always requires the filling of the chamber. drip after completion of each drug administered.

The way of filling the safety or universal equipment, whether those of type A or type B, is done in the same way and presents the same inconvenience, namely the mixing of the washing serum with the drug. This mixture is produced by having to act as follows: after finishing the administered drug, the clamp of the secondary system that contained it is closed, but a quantity of drug is housed in the space between the main clamp of the safety or universal equipment , the connectors and the drip chamber. When the main clamp is opened to clean the safety equipment, the serum descends to the aforementioned space by filling it and mixing with the remaining cytostatic drug housed there, so that when performing the filling procedure of the chamber, which consists of compressing it, it rises the mixture of serum and drug into the washing serum container bag, and then the chamber air rises, which after decompression the mixed serum descends, filling the drip chamber. This inconvenience is very difficult to observe because the cytostatic drugs are colorless, except a few, such as adriamycin that is red, and it was with this drug, and when performing the refill maneuver, when the coloration of the Container bag of washing serum and the existence of contamination.

To solve these drawbacks, the present invention avoids the mixing of washing serum with cytostatic drug residues in the drip chamber filling maneuver, extracting said drug remains and allowing the drip chamber to be refilled. The present invention also enables the extraction of existing air inside the safety equipment, all in a safe way.

DESCRIPTION OF THE INVENTION The present invention provides both safety and universal equipment, the possibility of performing, after the end of the administration of each cytostatic drug, a washing of the section of the safety equipment comprised between the piercing punch and the drip chamber, section in which remains of the administered drug are housed. Without this washing of the aforementioned section and when it was necessary to fill the drip chamber, the remains would inevitably ascend when performing the filling maneuver to the washing serum bag, contaminating it with cytostatic drug, and depriving it of its washing function. Likewise, this contamination would be repeated as many times as the refilling maneuver was carried out as usual treatments with several cytostatic drugs or polychemotherapy, which causes several drugs to be mixed in the wash serum bag, administering said mixture of drugs and serum to the patient without the safety or universal equipment being clean nor the patient's vein. The current systems also do not allow a safe disconnection of the equipment, highly dangerous and prohibited actions, and which are avoided when washing with this device.

It is therefore a first object of the present invention a device according to claim 1, comprising: a first end with a punch (2) punch, a tubing, or tube, (4) flexible without instant folding memory provided with a first clamp (5) clamp type, a second end with an integrated connector (6) for needle-free access type slip / luer-lock, and a branch that starts from the tubular (4), between the first clamp (5) and the second end with the integrated connector (6), said branch comprising a second clamp type clamp (7) and at its free end a connection (8) slip / luer-lock type with unidirectional valve and a protective cap (9) to guarantee the device sterility.

A second object of the present invention is a security equipment, according to claim 8, comprising a punch punch for connecting the clean serum supply container, a main clamp closure followed by as many needleless access safety connections as necessary. , a drip chamber, a connection to a pump and a tubulator, or tube, and a connection (11) for needle / slip / luer-lock type access following the drip chamber.

A third object of the present invention is a system according to claim 9 comprising the connected device and equipment connected above.

The present invention allows the washing of the cytostatic drug delivery equipment, in particular the section between the punch punch of the clean serum bag and the drip chamber filling up to its optimum level said chamber by aspiration with a syringe. The invention also makes it possible to extract the air in the event of a malfunction of the pump sensors, air that could have been introduced inside the tubing, or tube, of the safety equipment, whatever its location, when performing said extraction of air by aspiration with the syringe and in a completely safe way, leaving the safety team for the administration of cytostatic drug prepared to restart or initiate pharmacological administration, without loss of drug to be administered to the patient and without putting Danger the physical integrity of the patient or the handling staff. Said bag must be suitable for containing cytostatic drugs, that is, it must be made of a low-absorption and phthalate-free material (DEHP). Likewise, the tubulators or tubes through which the cytostatic drug could circulate must also be of a low-absorption and phthalate-free material (DEHP), that is, of a material approved for the administration of cytostatics. The bags are known in the sector as Viaflo bags usually made of polyolefin and / or polyamide.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made of the object of the invention and to help a better understanding of the characteristics that distinguish it, the present descriptive report is attached to the following figures that are illustrative and not limiting in nature:

Figures 1, 2 and 3 individually show each of the elements that make up the closed device for the filling object of the invention, in particular: Figure 1 shows a view of the collection bag (1) in material resistant to cytostatic drugs , type Viaflo or similar with a minimum capacity of 250 ml; Figure 2 shows the punch (2) perforator with protector and air inlet filter (3), the flexible tubular (4) and without instant folding memory, first clamp (5) clam type, the integrated connector (6) for Needle-free access slip / luer-lock type, the syringe (10) of the threaded type, a second clamp (7) clamp type, and at the distal end a connection (8) slip / luer-lock type with unidirectional valve and with cap protector (9); Figure 3 shows a syringe with threaded connector (10).

Figure 4 shows a safety device with drip chamber with sensor.

Figure 5 shows a safety equipment with a drip chamber with a ball. Figure 6 shows the exact location of the safety equipment, according to the invention, with drip chamber with drop sensor in which a connection (11) for needle / slip / luer-lock type access is included just after the camera drip

Figure 7 shows the exact location of the safety equipment, according to the invention, with a drip chamber with a ball in which a connection (11) for needle / slip / luer-lock type access is included just after the drip chamber .

Figure 8 shows the system object of the invention with the integration of the filling device with the safety equipment. PREFERRED FORM OF THE INVENTION

As mentioned, the present invention describes three different objects to achieve the filling of the drip chamber of the safety equipment during the administration of cytostatics with pump connection, namely a closed device, a safety equipment and a system formed by the connection of the above objects of invention. Next, a preferred embodiment of said invention will be described.

The filling device comprises a first end with a punch (2) perforator with protector and filter (3) of hydrophobic and antibacterial air intake with hydrophobic glass fiber membrane, and according to ISO standard, at the other end of the punch will be assembled the tubuladora, or tube, (4) that will be flexible and of the necessary length from the location of the collection bag to the point of connection with the safety equipment. This tube will not have instant folding memory and will be made of material approved for the administration of cytostatic drugs. The tubing or tube (4) will have a connector (6) integrated for access without a needle type slip / luer-lock at a second end, and will comprise a first clamp (5) clamp type located between the punch (2) and the integrated connector (6) where a syringe (10) of the threaded type will be installed to ensure a secure and closed connection. Between said first clamp (5) and the second end, the device comprises a branch (17) that ends at its free end with a slip / luerlock type connection (8) with a unidirectional valve, to allow the passage of air and / or safety equipment liquid or universal towards the refilling device avoiding the possibility of reflux from it to the equipment, and with hydrophobic and antibacterial protective cap. Said branch (17) comprises a second clamp (7) clamp type between the tubing (4) and its free end. The punch (2) is preferably connected with an empty bag collect (1) with a minimum capacity of 250 ml and of the Viaflo or similar type, which may be hung from the dropper stick.

The safety equipment object of the invention comprises a punch punch (12) for connecting the clean serum supply container (not shown), a main clamp closure (15) followed by how many access safety connections (16) without a needle if necessary, a drip chamber (13), a connection to the pump and a tubulator, or tube, (14) and a connection (11) to connect the safety equipment with the safety device of the needleless type slip / luer-lock and located just after the drip chamber (13).

For the operation of the safety device and equipment objects of the present invention, the connection (8) arranged at the free end of the branch of the device is connected to the connection (11) of the safety equipment arranged immediately after the drip chamber (13), before connection to the pump.

To fill the drip chamber (13) with the closed device for filling the safety equipment for the administration of cytostatics with pump connection object of the invention, and which we will call filling device, this will be connected to the safety equipment as described above forming a drip chamber refill system (13) of a safety equipment. In turn, the safety equipment is connected to a secondary equipment or system (not shown), through the safety connections (16) of said safety equipment, which comprises the cytostatic drug to be administered and which is provided with a piercing punch, a flexible extension tube without instant folding memory with integrated connector for needleless access, a clamp-type closure, and at its distal end a slip / luer-lock type connection with hydrophobic protector and with a protective cap for which it remains connected the secondary equipment to the safety equipment, specifically to one of the connections of the safety equipment.

Once the different equipment and devices are connected, and after a first drug has been administered to the patient, the clamp of the system or secondary equipment of the administered drug will be closed (not shown), and the main clamp (15) of the safety equipment will be opened or universal, located between the clean serum bag (not shown) and the safety connections (16), as well as the second clamp (7) of the filling device. Next, the drip chamber (13) will be inverted and the necessary volume of air from the drip chamber (13) will be aspirated with the syringe (10) to achieve the filling of the same with the clean serum dragging the remains of drug housed here and cleaning the safety equipment and until reaching the optimum level indicated in said chamber (13). Once the drip chamber (13) is filled, the second clamp (7) of the filling device will be closed and the drip chamber (13) will be placed in its initial position.

In this way, the safety equipment will be prepared to proceed with the washing of the central line, dragging the entire drug and leaving both the safety or universal equipment and the patient's vein completely clean.

The air deposited in the syringe (10) and probably a negligible amount of liquid containing serum and drug, will be deposited in the collection bag (1) connected by the punch (2), for which the first clamp (5) will be opened and the syringe (10) will be emptied, then closing said first clamp (5) once said deposit is made. In this way the filling device is prepared to be able to perform the filling maneuver again, if necessary.

With the present invention it is achieved:

administer all the drugs,

wash the safety equipment from the punch to the drip chamber preventing cytostatic drugs from mixing with the washing serum, and

wash the patient's vein with serum, preventing it from being injured.

To extract the air that could have been introduced into the safety equipment, air located between the drip chamber (13) and / or the pump connector and / or at any other point of the tubing or tube (14) would be carried out the extraction of air by closing all clamps, both of the equipment or secondary systems, and of the main safety or universal equipment. For this, the pump safety equipment will be removed, the second clamp (7) of the filling device will be opened and the mechanism located in the pump connector will be opened, allowing the aspiration of the air with the syringe (10). The pump connection has a mechanism that provides, at the moment of disconnecting it from the pump, an automatic closing of the light of the tubing machine avoiding the passage through this connection of fluids and / or air, which by gravity could descend towards the patient. Subsequently in the filling device the second clamp (7) will be closed, the safety or universal equipment will be reconnected to the pump, and the first clamp (5) will be opened to be able to deposit the air in the collection bag (1) contained in the syringe (10). After this, the first clamp (5) will be closed and the main clamp (15) of the safety equipment will be opened or universal, by performing the aforementioned maneuver of filling the drip chamber (13), so that the pump will be ready to continue working.

The present invention also achieves:

The extraction of air safely from inside the safety equipment,

avoid possible malicious effects on the patient by extracting the air that had been introduced into the equipment, and

check the permeability of the venous access catheter to the patient.

Claims

1. Closed device for filling the drip chamber of the safety equipment for the administration of cytostatics with pump connection, characterized in that it comprises:

a first end with a punch (2) punch,

a tubing, or tube, (4) flexible without instant folding memory provided with a first clamp (5) clamp type,

a second end with an integrated connector (6) for needle-free access type slip / luer-lock, and

a branch that starts from the tubing (4), between the first clamp (5) and the second end with the integrated connector (6), said branch comprising a second clamp-type clamp (7) and at its free end a connection ( 8) slip / luer-lock type with unidirectional valve.

2. Device according to claim 1, characterized in that it comprises at the first end a collection bag (1) for storing the extracted air, the serum, the rest of the cytostatic drug or the mixture thereof with the serum, after the filling process of the drip chamber of the security team.

3. Device according to claim 2, characterized in that the collection bag is made of a low absorption and phthalate free material (DEHP).

Device according to claim 1, characterized in that the punch (2) comprises a protector and filter (3) of the type of hydrophobic and antibacterial air inlet with hydrophobic glass fiber membrane that ensures the impossibility of leaving the content that has been deposited in the collection bag.

Device according to claim 1, characterized in that the connection (8) located at the free end of the branch comprises a protective cap (9) with hydrophobic and antibacterial protector.

6. Device according to claim 1, characterized in that the tubulator (4) is made of low absorption and phthalate free material (DEHP), approved for the administration of cytostatic drugs.

Device according to claim 1, characterized in that it comprises a syringe of the threaded type connected to the connector (6) disposed at the second end.

8. Safety equipment for the administration of cytostatics with pump connection, of the type comprising a punch punch (12) to connect the clean serum supply container, a main clamp type closure (15) followed by how many safety connections ( 16) Needle-free access is necessary, a drip chamber (13), a connection to the pump and a tubing, or tube, (14) characterized in that it comprises a connection (11) for access without a slip / luer-lock type needle next to the drip chamber (13).

9. Filling system of the drip chamber (13) of safety equipment, characterized in that it comprises a device according to claims 1 to

7 and a security equipment according to claim 8, connected by the connection (8) located at the free end of the branch of the device and the connection (11) for needleless access of the security equipment.