RU201735U1 - Subcutaneous implantable port - Google Patents

Abstract

The utility model relates to the field of medicine and can be used for diseases that require frequent and safe venous or arterial access to venous or arterial blood flow or to the abdominal cavity. The claimed port comprises a port body, a screwed port cover, a camera, a port-to-catheter connection device, and a silicone membrane septum. The membrane is made of silicone with the inclusion of white pigment and has a Shore hardness of about 40-50. The wall width of the port base chamber is at least 2.15 mm. The technical result is the elimination of accidental damage to the needle and the ingress of small breakaway particles of the material from which the needle is made into the drug.

Description

The utility model relates to the field of medicine, namely, to a subcutaneously implantable port system and can be used for diseases that require frequent and safe venous or arterial access to venous or arterial blood flow or to the abdominal cavity.

An infusion port is known from the prior art, which is a titanium reservoir in the form of a thick coin with a diameter of about 4-4.5 cm and a thickness of about 1 cm, which is coated from the inside with a bioinert polymer. A multilayer silicone membrane is installed on its upper flat part, through which drugs are injected. The port has a thin catheter tube up to 10-15 cm long, which is passed into the jugular vein and, less often, into the artery. The infusion port itself is usually placed under the skin in the upper third of the chest during minor surgery. The place and method of setting up the port system is determined by the general condition of the patient and the planned type of treatment. (Internet source: https://www.euroonco.ru/departments/himioterapiya/infuzionnye-port-sistemy © European Clinic of Oncology).

To install the infusion port, after treating the skin with a special disinfectant solution, a needle is injected into the central vein, then a thin metal guide is inserted into the needle, through which a special catheter is inserted about 2 mm in diameter. A small skin incision is made and the port is placed under the skin, then the port and the catheter inserted into the vein are connected. The incision is sutured with several cosmetic sutures. Internet source: https://www.euroonco.ru/departments/himioterapiya/infuzionnye-port-sistemy © European Clinic of Oncology).

Known port system (DE102007014086 (A1) published 2008-09-11) which is a port body having a chamber that is open on one side and a membrane-shaped partition provided for closing the port chamber, which is fixed with a screw cap, a connection device port with a catheter. The membrane is made of silicone and has a low Shore hardness of about 20-30 and high elasticity. While usually silicone membranes with a hardness of about 70 Shore are used for port systems. To prevent the membrane from moving downward into the port chamber area when the cannula is inserted into the membrane, a support member is provided that is attached to the port body in the upper access area and is made of a material that is more rigid than the membrane. The support member has an outer annular portion and three rods, the rods defining linear support points for the septum 4. As a result, fluid in the port chamber through the catheter can be prevented from escaping into the patient's body as a result of penetration or immersion of the septum 4 into the port chamber 2. In the state of implantation of the port catheter, said membrane allows access to the port chamber through the patient's skin from above, through a cannula inserted through the membrane into the port chamber.

The disadvantage of the prototype is the low probability of accurate determination of the puncture site with a Huber needle during palpation, due to the presence of a supporting element for the membrane attached in the area of the upper access of the port body, which, if the needle accidentally contacts the supporting element, can lead to the ingress of small breakaway particles of material into the drug from which the support or needle is made. And besides. complicates the manufacturing and assembly of the port.

The task of the utility model is to create a port system that ensures reliable determination of the puncture site with a Huber needle.

The technical result is the elimination of accidental damage to the needle and the ingress of small breakaway particles of the material from which the needle is made into the drug due to the use of a silicone membrane, which contains the white pigment MED 4800-1 white, which makes it possible for diaphanoscopy with an ultraviolet beam of light, especially in patients with pronounced subcutaneous fat, determine the exact location of the membrane by the appearance of a light blue spot at the site of the membrane. In addition, the elimination of accidental damage to the needle ensures that there is no support element in the port, while maintaining reliable fixation of the membrane on the walls of the port base when the port cover is screwed on by increasing the width of the chamber wall of the port base to 2.15 mm, which is guaranteed to exclude accidental damage to the needle and into the drug of small breakaway particles of the material from which the needle is made. At the same time, it is sufficient that the hardness of the membrane Shore does not exceed 40-50, which, despite the lower hardness than that of commonly used membranes with a hardness of about 70 Shore, is sufficient for reliable fixation of the membrane, and therefore prevents it from moving down into the port chamber area ...

The problem is solved by the proposed device containing a port housing with a chamber that is open on one side, a septum in the form of a membrane, a screw cap, a device for connecting the port to a catheter, into which the following new features are introduced:

- the membrane with a Shore hardness of about 40-50 is made of silicone with the inclusion of a white pigment, which makes it possible to determine the exact location of the membrane by the appearance of a light blue spot in the place of the membrane during diaphanoscopy with an ultraviolet light beam;

- the width of the chamber wall of the port base is at least 2.15 mm, which is sufficient support for fixing the membrane when the screw cap is screwed on and prevents it from moving down into the area of the port chamber, and at the same time practically does not reduce the volume of the chamber. Reliable fixation of the membrane is an extremely important condition for achieving the technical result, since when it moves down into the area of the port chamber, accidental damage to the needle, a change in the volume of the chamber and its occlusion may occur, which will require its reinplantation.

Distinctive essential features of the claimed utility model are in causal relationship with the achieved technical result. The set of essential features is unknown from the prior art, therefore, the compliance with the condition of novelty is fulfilled. The condition of compliance with industrial applicability is confirmed by the examples of implementation.

The disassembled utility model is shown in the figure, where

1 - port base

2 - screwed port cover

3 - catheter connecting part

4 - device for fixing the catheter.

5 - silicone membrane.

The proposed implantable subcutaneous port system contains a port base 1, in which the width of the port base chamber wall is at least 2.15 mm, a screw-on port cover 2, a port-catheter connection device in the form of a catheter connecting part 3 and a device 4 for fixing the catheter, a membrane 5 made of silicone with the inclusion of white pigment and a Shore hardness of about 40-50.

The device works as follows.

When assembling the device, the membrane is positioned so that its edges evenly cover the upper part of the chamber wall of the base 1 of the port and screw the cover 2 of the port. When screwing the port cover 2, the membrane 5 is securely fixed between the cover 2 and the upper part of the chamber wall of the port base 1. The fully assembled device is implanted subcutaneously in the area of the projection of the human body cavity that requires a therapeutic effect, and is fixed to it with sterile absorbable ligatures. Before implantation, the port should be filled with saline to prevent air bubbles from entering the catheter, which is connected to the port by means of a catheter connecting part 3 and a catheter fixation device 4. The catheter diverting from the body is directed into the central vein or cavity of the human body (pleural, abdominal, amniotic). The introduction of the drug is carried out after piercing the silicone membrane of the port with a Huber needle, detected by palpation or by means of diaphanoscopy for patients with pronounced subcutaneous fat by the appearance of a blue-white spot. The needle penetrates freely without encountering resistance. Then it is possible to connect any version of the infusion system and administer the drug or solution. After the end of use, the needle is also freely removed from the port and sent for disposal.

Specific examples of implementation.

Example 1. Using a port system with a support element.

Patient V-na L.V., 36 years old. She was observed in the perinatal center of the Belgorod Regional Clinical Hospital of St. Joasaph.

Anamnesis: no chronic diseases; Allergy anamnesis is calm, Sexual life since 23 years, during the last three years the method of contraception is a barrier method. The number of sexual partners is 3.

Extragenital diseases: chronic right-sided pyelonephritis.

The last pregnancy was uneventful.

In dynamic observation, in accordance with the standards of examination of a pregnant woman, a complete clinical and laboratory examination was carried out.

Ultrasound examination revealed no pathological changes. The placenta is located along the back wall of the uterus with the transition to the left rib.

Examination for urogenital infection was not identified.

At a gestational age of 24-25 weeks, a premature rupture of amniotic fluid was recorded. According to the examination, oligohydramnios was diagnosed. In this regard, it was proposed to prolong pregnancy by carrying out continuous amnioinfusion by the method of M. Tchirikov (2013) using a port system with a supporting element. After installing the catheter, a skin incision was made with a length of 1.5 - 3 cm with the formation of a subcutaneous "pocket". The coated port immersed in it was fixed with separate sutures to the adjacent tissues. The skin incision was sutured in layers. At all stages, and especially before the end of implantation, the patency of the catheter and port was controlled by aspiration of amniotic fluid from the catheter using a Huber needle.

No complications (chorioamnionitis, preterm labor, premature detachment of the normally located placenta) were found after 14 days of procedures through an installed catheter.

Technical violations of the use of the port system: when the Huber needle was inserted, it hit the support element with biting off the tip of the needle.

The need to use a new Huber needle - yes.

The frequency of needle damage during the period of use of the port system is 4.

Example 2. Using the proposed port system.

Patient E-va V.N., 32 years old. She was observed in the perinatal center of the Belgorod Regional Clinical Hospital of St. Joasaph.

Anamnesis: chronic unilateral salpingo-oophoritis; at the age of 26 - medical abortion. Sexual life from 18 years without the use of contraceptive methods. The number of sexual partners is 2.

Extragenital diseases: no.

The last pregnancy was uneventful. An additional condition was the presence of lipid metabolism disorders with the formation of BMI - 35, which was manifested by the presence of pronounced subcutaneous fat.

In dynamic observation, in accordance with the standards of examination of a pregnant woman, a complete clinical and laboratory examination was carried out.

Ultrasound examination revealed no pathological changes. The placenta is located along the anterior wall of the uterus.

Examination for urogenital infection was not identified.

At a gestation period of 26-27 weeks, premature rupture of amniotic fluid was recorded. According to the examination, oligohydramnios was diagnosed. In this regard, it was proposed to prolong pregnancy by carrying out continuous amnioinfusion using the method of M. Tchirikov (2013) and using the proposed port system without a support element. After installing the catheter, a skin incision was made with a length of 1.5 - 3 cm with the formation of a subcutaneous "pocket". The coated port immersed in it was fixed with separate sutures to the adjacent tissues. The skin incision was sutured in layers. At all stages, and especially before the end of implantation, the patency of the catheter and port was controlled by aspiration of amniotic fluid from the catheter using a Huber needle.

During 14 days of performing procedures through an installed catheter by piercing the silicone membrane of the port, detected by transillumination with a Huber needle, there were no complications that usually occur after invasive intrauterine therapy in pregnant women, such as: chorioamnionitis, premature birth, premature detachment is normal located placenta.

Technical violations of the use of the port system: no.

The need to use a new Huber needle is not.

The frequency of needle damage during the period of use of the port system - 0

The operation of installing the claimed utility model is possible in any hospital equipped with the necessary equipment. The design of the device can be mastered at enterprises producing medical equipment and instruments.

Claims (1)

A subcutaneously implantable port containing a port body, a screwed port cover, a camera, a device for connecting the port to a catheter and a silicone membrane septum, characterized in that the membrane is made of silicone with a Shore 40-50 hardness, which contains the white pigment MED 4800-1 white.

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