WO2021059011A1

WO2021059011A1 - Double-sided injection applicator

Info

Publication number: WO2021059011A1
Application number: PCT/IB2019/059884
Authority: WO
Inventors: Pavel Kucera
Original assignee: Promoton s.r.o.
Priority date: 2019-09-25
Filing date: 2019-11-18
Publication date: 2021-04-01
Also published as: CZ33333U1; EP4034189A1

Abstract

Double-sided injection applicator, consisting of a body, a central channel and an air outlet duct, where the central channel (3) in the body (1) has an upper air outlet duct (4) and an upper supporting area (8) placed on one side and a lower air outlet duct (6) and a lower supporting area (9) on the other side. The upper supporting area (8) is below the upper flat area (5) level while the lower supporting area (9) is below the lower flat area (7) level, and the central channel (3) has a narrowing (2) of the central channel (3) below the upper supporting area (8). The lower supporting area (9) is recessed in the body (1) by at least 1/7 of the total height of the body (1) compared to the lower flat area (7).

Description

Double-sided injection applicator

Technical Fields

The invention concerns a specially made double-sided device, manufactured from one piece of material, for correct, safe and harmless administration of the medicine contained in the pre-filled syringe.

Background Arts

Medicinal products and medications can be delivered into the human body using several methods. Apart from oral administration, one of the most widespread methods is parenteral administration, which involves intravenous, intramuscular or subcutaneous application. Parenteral administration is used if the drug is not absorbed by the intestinal or gastric mucosa or if it is destroyed in the stomach or intestine. The method used consists in subcutaneous administration of drugs, i.e. application of the active substances by injection, infusion or implantation into the subcutaneous tissue, which allows the application of a number of substances, particularly of a protein nature. These are mainly insulin products, as well as a number of other recombinantly prepared hormonal preparations, anticoagulant or biological drugs in the treatment of inflammatory rheumatic diseases and multiple sclerosis or in oncology.

In the context of drug injection, the syringe is known as a simple medical device in the form of a plunger tightly fitted into a (mostly plastic or glass) container forming a chamber whose mouth is adapted to a standard cone onto which a syringe needle or connecting tube can be attached. The syringe is mostly used directly by doctors or other health care professionals and, to a lesser extent, by patients themselves, as its use requires carefulness, caution and, in particular, knowledge of the site, depth and intensity of injection, as well as the speed of application of the substance injected.

In order to self-administer the medicinal product with the active substance in liquid form there are, inter alia, “diabetic syringes” which, unlike ordinary medical syringes, do not have a thumb rest, since they are supposed to be used by patients themselves, i.e. using a different grip of the syringe with the needle facing inwards, unlike the medical ones used by the attending person and applied to the patient. Diabetic syringes only have a small volume (approx. 5 ccm) and, instead of a pressure area, have a thin plunger end; in addition, this end is rough to make it easier to move the plunger in both directions, even with just a single hand. Needles are not attached to such syringes, because they come with a pre-installed needle from production, i.e. they are disposable. In any case, administration must again be conducted by a certain person, and although diabetic syringes are more adapted for self-administration, they do not eliminate the complications relating to the suitability of the site, depth and intensity of injection, as well as the speed of application of the substance injected.

Another method used for self-administration of a liquid active substance is offered by pre-filled applicators, mostly semi-automatic or fully automatic injection pens (e.g. EP 1744799 Al, US 2017/246389 Al, WO 94/26331 Al, US 2017/239421 Al). When the pen is placed onto the patient’s body, the needle is inserted into the patient’s tissue and the medicinal product is automatically pushed out. However, the patient is unable to influence the intensity and speed of injection or, more precisely, administration of the medicinal product with the active substance. It is very difficult to give an injection in the ideal perpendicular direction, as the applicators have a small base. Injection is very fast and the medicinal product tends to flow out of the site of injection. This is also often exacerbated by the patient’s startle (both because of the sound produced by the released spring and because of the rapid and surprising injection) and a partial pull-out of the applicator. Preparing the entire automatic applicator is complicated for the patient and consists of precise steps that take the patient about a minute. Patients experience more frequent skin atrophy connected with rapid injection. Any unpleasant experience of administering a medicinal product results in the patient’s reluctance to continue treatment. Part of these drawbacks is overcome by the device WO 2017/179638 Al, which allows, for example, vertical application. The technical solutions AU 2008/101111 A4, US 2016/310672 Al and US 2017/246389 can also be considered to be technologically close. In the case of AU 2008/101111 A4, the patient is provided psychological relief because the syringe is hidden, but hiding is not complete and there is no possibility of fixing any injection angle.

The closest technological solutions are currently the applicant’s technical solution preferentially submitted as utility model CZ 31409. The device allows control of the angle, depth and speed of injection, is user friendly and consists of one piece of material, eliminating the possibility of breakage or complication during assembly. The disadvantage of this device is the structural adaptation to only one particular type and shape of pre-filled syringes, which allows the device to be used to administer only that single type of pre-filled syringe. This has been shown to be a disadvantage in practice, for example, in the case of subcutaneously administered blood thinning drugs (low-molecular-weight heparins - LMWH), where patients alternately take, for example, two different drugs administered from two different pre-filled syringes. Thus, it is desirable to have a highly versatile solution capable of serving multiple types of pre-filled syringes in a single technical solution.

Disclosure of Invention

These above mentioned drawbacks are eliminated by the device for double-sided injection proposed in this invention, whose essence lies in the fact that the central channel in the body has an upper air outlet duct and an upper supporting area on one side and a lower air outlet duct and a lower supporting area on the other side. The upper supporting area is below the upper flat area level while the lower supporting area is below the lower flat area level, and the central channel has a narrowing of the central channel below the upper supporting area. Compared to the lower flat area, the lower supporting area is recessed in the body by at least 1/7 of the total height of the body, which is beneficial.

Based on the above invention, the double-sided injection applicator has several advantages over the current state of the art. One of the major advantages is that it can be used for a variety of pre-filled syringes within its double-sided use. The device also emphasises the possibility of administering the drug individually at an optimum speed and controlling the speed of administration of the drug-containing liquid product into the body. The device hides the syringe, which reduces the fear of application. The device is made of one piece of rubber or silicone and is therefore durable and easy to wash or, as the case may be, sterilise. The device helps to reduce the carbon footprint and the environmental burden by enabling interchangeability of medicines, thereby reducing the need to purchase multiple applicators.

Brief Description of Drawings

The invention will be further clarified by means of drawings. Fig. 1 shows the device from the rear, Fig. 2 shows the device from below, Fig. 3 shows the device from above, Fig. 4 shows a cross-section of the device, Fig. 5 shows syringes placed in the device from both sides. Fig. 6 and Fig. 7 show axonometric views of the device in 3D modulation. Made for Carrying out the Invention

Example 1

The double-sided injection applicator made entirely of soft medical silicone consists of a body 1 of the device with a central channel 3 for placing a syringe leading through the device from top to bottom. At the top of the device there is an upper flat area 5 into which the central channel 3 opens through an extension formed by an upper supporting area 8. Below the upper supporting area 8 there is a narrowing 2 of the central channel 3. In its lower part, the central channel 3 ends in a lower supporting area 9 which is recessed 1/7 of the height of the body 1 in the body 1 compared to the lower flat area 7. The body 1 is cut at its rear along the entire length of the central channel 3, with an upper air outlet duct 4 located on one side in the upper part of the central channel 3 and a lower air outlet duct 6 located on both sides in the lower part of the central channel 3.

The injection applicator is used as follows: the patient opens the body J_ of the device, which is cut at its rear along the entire length of the central channel 3, inserting a pre-filled syringe for administering the medicinal product into the central channel 3 from above. The projections on the syringe, which are commonly used to wedge fingers, are placed in the upper supporting area 8, which is recessed compared to the upper flat area 5. The height of the body 1 is determined to ensure that only a syringe needle protrudes from below the lower flat area 7 in a length corresponding to the ideal injection depth. After the syringe is inserted into the central channel 3, the patient removes the needle protection cap on the syringe through the lower air outlet duct 6. Furthermore, the body of the device is gripped in the palm of the hand. The body 1 of the device is rounded to fit ergonomically into the patient’s hand. At the same time, given the shape of the palm and the rounded shape of the side part of the body J_, the syringe is evenly and securely fixed in the central channel 3 along its entire length. If the device is used from the upper part, the narrowing 2 of the central channel 3 is deformed, which facilitates stronger fixation of the syringe in the body of the device in its upper part. The patient injects the medicinal product with the active substance by inserting the needle into his/her body. If device is used through the top part, there is no compressed air at the injection site between the patient’s body and the flat area 5 which ensures a perpendicular placement of the syringe needle when the liquid product with the active substance is administered into the body, i.e. the air freely flows out through the lower air outlet duct 6. After the medicinal product is administered / pushed out of the syringe, the patient slightly opens the body 1 of the device with one hand, removing the syringe from the central channel 3 with the other hand and putting the used syringe in a dedicated collection container. This makes the device ready for further use.

Example 2

The double-sided injection applicator made entirely of rubber consists of a body 1 of the device with a central channel 3 for placing a syringe leading through the device from top to bottom. At the top of the device there is an upper flat area 5 into which the central channel 3 opens through an extension formed by an upper supporting area 8. Below the upper supporting area 8 there is a narrowing 2 of the central channel 3. In its lower part, the central channel 3 ends in a lower supporting area 9 which is recessed 2/7 of the height of the body J_ in the body 1_ compared to the lower flat area 7. The body J_ is cut at its rear along the entire length of the central channel 3, with an upper air outlet duct 4 located on one side in the upper part of the central channel 3 and a lower air outlet duct 6 located on both sides in the lower part of the central channel 3.

The injection applicator is used as follows: the patient opens the body 1 of the device, which is cut at its rear along the entire length of the central channel 3, inserting a pre-filled syringe for administering the medicinal product into the central channel 3 from below. The projections on the syringe, which are commonly used to wedge fingers, are placed in the lower supporting area 9, which is recessed compared to the lower flat area 7. The height of the body 1 is determined to ensure that only a syringe needle protrudes from above the upper flat area 5 in a length corresponding to the ideal injection depth. The narrowing 2 of the central channel 3 follows the shape of the syringe, fixing it against unwanted movement. After the syringe is inserted into the central channel 3, the patient removes the needle protection cap on the syringe; this is made possible by the upper supporting area 8, which in this case forms an extension of the central channel 3. Furthermore, the body J_ of the device is gripped in the palm of the hand. The body 1 of the device is rounded to fit ergonomically into the patient’s hand. At the same time, given the shape of the palm and the rounded shape of the side part of the body 1_, the syringe is evenly and securely fixed in the central channel 3 along its entire length. The patient injects the medicinal product with the active substance by inserting the needle into his/her body. The air compressed between the patient’s body and the flat area 5 which ensures a perpendicular placement of the syringe needle when the liquid product with the active substance is administered into the body flows out through the upper supporting area 8 into the upper air outlet duct 4. After the medicinal product is administered / pushed out of the syringe, the patient slightly opens the body 1 of the device with one hand, pulling the syringe wings to attach the syringe protection tube onto the needle, and removes the syringe from the central channel 3 with the other hand, putting the used syringe in a dedicated collection container. This makes the device ready for further use.

Industrial applicability

The double-sided injection applicator can be used in health care or, as the case may be, in injecting the medicinal product, either by self-administration or by third party administration.

List of related tass/markinss

1 body

2 narrowing of the central channel

3 central channel

4 upper air outlet duct

5 upper flat area

6 lower air outlet duct

7 lower flat area

8 upper supporting area

9 lower supporting area

Claims

PA T E N T C L A IM S

1. Double-sided injection applicator, consisting of a body, a central channel and an air outlet duct, is characterised in that the central channel (3) in the body (1) has an upper air outlet duct (4) and an upper supporting area (8) placed on one side and a lower air outlet duct (6) and a lower supporting area (9) on the other side, where the upper supporting area (8) is below the upper flat area (5) level while the lower supporting area (9) is below the lower flat area (7) level, and the central channel (3) has a narrowing (2) of the central channel (3) below the upper supporting area (8).

2. Double-sided injection applicator according to claim 1 is characterised in that the lower supporting area (9) is recessed in the body (1) by at least 1/7 of the total height of the body (1) compared to the lower flat area (7).