RU2850704C1 - Implantable infusion port - Google Patents

Abstract

FIELD: implants.

SUBSTANCE: invention relates to implants used in medicine, and more specifically to subcutaneous infusion implantable ports used to provide repeated internal access to the vascular system of people who need long-term and regular chemotherapy, hydration, drainage, administration of antibacterial, antiviral and analgesic drugs, parenteral nutrition, blood collection or transfusion, and contrast-enhanced computed tomography. The implantable infusion port comprises a housing with a fluid cavity connected to a connector located on the side of the housing, a cover, a membrane hermetically sealed between the cover and the body, made of a needle-permeable material, and a clamping cap with a cavity for installation on the connector and a through hole for installing and clamping the catheter tube on the connector. The cover is made with a through hole. The outer surface of the body has mounting lugs located at an angle of 120 degrees to each other. The cover is designed to allow access to the membrane and has a cylindrical protrusion on its lower surface. The lower outer surface of the cylindrical protrusion has diametrically opposed petals-protrusions. Diametrically opposed petals-protrusions are formed on the upper inner cylindrical surface of the housing. The cover is designed to be fixed in the housing by rotating the cover 90 degrees. A housing gasket is installed between the upper outer surface of the housing and the lower surface of the cover. The membrane is installed in the inner cavity of the cylindrical protrusion of the cover. The mounting lug located on the side of the body diametrically opposite the nozzle is trapezoidal in shape with a protrusion that curves in a direction below the bottom of the port and tapers towards the axis of symmetry of the body with a bend radius of 3 mm to 4 mm.

EFFECT: ensuring quick, reliable and easy attachment and detachment of the implantable infusion port to the subcutaneous tissues, ensuring reliable, tight and easy detachable attachment of the cover to the body, ensuring quick, reliable and easy connection of the tube to the port connector; ensuring that the body, cover and other port components can be used repeatedly, provided that they can be cleaned, disinfected and sterilised (with the exception of punctured and damaged membranes, which must be replaced after prolonged use).

10 cl, 14 dwg

Description

The invention relates to implants used in medicine, and more specifically to subcutaneous implantable infusion ports used to provide multiple internal access to the vascular system of people requiring long-term and regular chemotherapy, hydration, drainage, administration of antibacterial, antiviral and pain-relieving drugs, parenteral nutrition, blood collection or transfusion, and performing computed tomography with contrast.

Infusion ports are subcutaneously implanted systems for administering medications and collecting and transfusing blood or blood components. The basic idea behind implantable infusion ports is to transform any complex infusion into a simple subcutaneous injection. An implantable infusion port is completely concealed beneath the skin. Because it lacks a permanent external component, an implantable infusion port is suitable for long-term use, does not burden the patient, and does not interfere with hygiene. Implantable infusion ports are used in patients with diagnosed cancer who are scheduled to undergo multiple chemotherapy sessions, particularly with cytostatic agents that damage peripheral veins. Additionally, implantable infusion ports are used in patients who are scheduled to receive long-term administration of medication solutions. Implantable infusion ports are used in patients with thin peripheral veins in the arms and legs. The use of an implantable infusion port as a vascular access device is particularly relevant for patients whose venous access is compromised by chemotherapy. Implantable infusion ports help ensure more effective, safe, and high-quality treatment. Patients can receive therapy both inpatient and outpatient. Given that implantable infusion ports are inserted subcutaneously, one of the primary goals in developing new designs is to minimize their size to facilitate implantation and healing at the insertion site.

A subcutaneous implantable port is known (RU 2683057, IPC A61M 39/02, published on March 26, 2019), comprising a triangular-shaped housing with rounded corners, inside which a reservoir for a fluid medium is installed, connected to a nozzle located on the side of the housing, a silicone membrane permeable to a needle, covering the reservoir and at least one suture hole, the membrane is made in the form of a truncated cone with a taper angle of 10 to 20°, the larger base of which is located on the side of the reservoir, while the diameter of the smaller base of the membrane is made from 7 to 15 mm, and the triangular housing is made with a length of 19 to 38 mm, a base width of 15 to 30 mm, and a height of 7 to 14 mm.

A subcutaneous implantable port is known (RU 205446 U1, IPC A61M 39/02, published 14.07.2021, prototype), comprising a housing in the form of an isosceles triangle made of a biocompatible polymeric material, a cavity for a fluid medium connected to a nozzle located on the side of the housing, a silicone membrane covering the cavity from above and a suture hole, the housing is made prefabricated, in the lower part of the housing a lid made of a biocompatible polymeric material is inserted with tension, in which a cavity for a fluid medium is formed with a titanium plate fixed to the bottom of the cavity, a fixing element in the form of a tongue is made on the side wall of the lid, with the possibility of its mating with a groove formed on the inner side wall of the housing, wherein the housing and the lid are additionally fastened together with a pin.

Known existing analog ports have the following disadvantages:

1) the lack of quick, reliable and easy attachment and detachment of the implantable infusion port to the subcutaneous tissues,

2) the lack of a reliable, sealed and simple detachable fastening of the cover to the body,

3) the inability to use the body, cover, and other parts of the port multiple times.

4) lack of quick, reliable and easy connection of the tube to the port fitting

The problem solved by the invention was to develop a design for an implantable infusion port that provides:

- fast, reliable and simple attachment and detachment of the implantable infusion port to the subcutaneous tissues,

- reliable, hermetically sealed and easy to detach lid fastening to the body,

- quick, reliable and easy connection of the tube to the port fitting;

- the possibility of using the body, cover, and other parts of the port repeatedly, provided that they can be cleaned, disinfected, and sterilized (with the exception of punctured and damaged membranes, which must be replaced after long-term use).

The technical result achieved is:

- to ensure fast, reliable and easy attachment and detachment of the implantable infusion port to the subcutaneous tissues,

- to ensure reliable, hermetically sealed and easy detachable fastening of the cover to the body,

- to ensure quick, reliable and easy connection of the tube to the port fitting;

- ensuring the possibility of using the body, cover, and other parts of the port repeatedly, provided that they can be cleaned, disinfected, and sterilized (with the exception of punctured and damaged membranes, which must be replaced after long-term use).

The technical result is achieved due to:

- An implantable infusion port comprising a housing with a cavity for a fluid medium connected to a nozzle located on the side of the housing, a membrane hermetically clamped between the cover and the housing, made of a material permeable to the needle, the cover is made with a through hole, and on the outer surface of the housing there are fastening ears located at an angle of 120 degrees with respect to each other, the cover is made with the possibility of access to the membrane and on the lower surface contains a cylindrical protrusion, on the lower outer surface of the cylindrical protrusion there are diametrically located petal-protrusions, on the upper inner cylindrical surface of the housing there are diametrically located petal-protrusions, wherein the cover is made with the possibility of fixing in the housing by turning the cover by 90 degrees, between the upper outer surface of the housing and the lower surface of the cover there is a housing gasket installed, the membrane is installed in the inner cavity of the cylindrical protrusion of the cover, the fastening ear located on the side of the housing diametrically opposite to the nozzle is made trapezoidal in shape with a protrusion bending towards the bottom of the port and tapering towards the axis of symmetry of the body with a bending radius of 3 mm to 4 mm, a clamping cap with a cavity for installation on the nozzle and a through narrowed hole for installation and clamping of the catheter tube on the nozzle.

- the membrane has the shape of a cylinder, consisting of one or more cylindrical elements made of elastomeric material.

- the membrane and the housing gasket are made as a single piece.

- the projection of the fastening eye contains blunt protruding teeth or spherical depressions.

- the cavity for the fluid medium in the housing is made stepped, and the housing is made of titanium or a titanium plate is installed on the bottom of the housing.

- a through hole is made in the center of the lid.

- the distal end of the nozzle is connected to the body by a threaded connection through a silicone gasket, the proximal end of the nozzle has a conical shape, while the nozzle is installed at an angle to the body.

- the fitting is made in the form of a tube with technological thickenings and depressions, and in the cavity of the clamping cap there is a thread or a circular depression in the form of a torus for a “radial” spring or a conical protrusion for elastic coupling with the fitting.

- the fitting is designed with the possibility of installing the distal end of the catheter tube, which has a smooth corrugated shape with cutting marks every 4 mm in the area of the larger diameter.

- the fitting is designed with the possibility of installing the proximal end of a catheter tube having a constant homogeneous diameter with cutting marks every 15 mm.

- a microvalve is installed in the fitting, designed with the ability to activate when the inlet pressure exceeds 3 atm.

Brief description of the drawings

Fig. 1(a) - Cross-sectional view of the implantable infusion port;

Fig. 1(b) - Cross-sectional view of the implantable infusion port with the membrane and housing gasket as a single piece structure

Fig. 2 - View of the implantable infusion port in partial longitudinal section;

Fig. 3 - Main view (front view) of the implantable infusion port;

Fig. 4 - Side view of the components of the implantable infusion port;

Fig. 5 - View (isometric view) of the component parts of the implantable infusion port with a threaded connection of the nozzle and clamp cap;

Fig. 6 - View (isometry) of the component parts of the implantable infusion port with the coupling of the nozzle and the clamping cap on the “radial” spring;

Fig. 7 - Main view (front view) of the implantable infusion port with snap-on nipple and clamp cap in section;

Fig. 8 - Installation of the clamp cap on the catheter tube at the required distance from the end of the tube;

Fig. 9 - Fixation on the “radial” spring of the clamping cap with the catheter tube on the infusion port nipple;

Fig. 10 (a) - Fixing the clamp cap with the catheter tube on the infusion port fitting using the slider of the hand tool;

Fig. 10 (b) - Second variant of fixing the clamp cap with the catheter tube on the infusion port fitting using the slider of the hand tool;

Fig. 11 - View (isometry) of an implantable infusion port with various designs of port “ears” for suturing it;

Fig. 12 - Installation of the clamp cap on the catheter tube with a smooth corrugated shape;

Fig. 13 - View of the catheter with a clamp cap installed on it, ready for subsequent installation on the infusion port nipple;

Fig. 14 - Fixation on the “radial” spring of the clamping cap with a catheter tube with a smooth corrugated shape on the infusion port nipple.

The implantable infusion port consists of:

FRAME

The outer diameter of the housing 1, in the preferred embodiment, is 22 mm, and the height is 6.5 mm. On the outer surface of the housing 1, a pair of ears 11 with an opening and an ear 12 without an opening are located for fastening at an angle of 120 degrees with respect to each other, which allows sewing the port only by two ears 11 easily accessible in the pocket between the tissues and the skin, without the need to additionally fix the port by the ear 12 on the side of the housing 1 diametrically opposite to the nozzle 3. The overall dimensions of the housing 1 together with the fastening ears 11, in the preferred embodiment, do not exceed 30 mm. In the housing 1, the cavity for the fluid is made stepped, wherein the housing 1 is made of titanium or a titanium plate is installed on the bottom of the housing 1. In the preferred embodiment, the diameter of the lower step of the cavity is 8 mm, and the height is 2.5 mm. In the preferred embodiment, the diameter of the upper stage of the cavity of the housing 1 is 17.5 mm. On the upper inner cylindrical surface of the housing 1, diametrically located petal-protrusions 14 are formed and directed inwardly of the housing 1. The inner diameter of the protrusions, in the preferred embodiment, is 14.5 mm, the thickness is 1 mm, and the width is 11 mm. On the outer side surface of the housing 1, a through threaded hole is located, communicating with the inner cavity of the lower stage of the housing 1. The fastening eye 12, located on the side of the housing 1 diametrically opposite to the nozzle 3, is made trapezoidal with a protrusion bending towards the bottom of the port and narrowing towards the axis of symmetry of the housing 1 with a bending radius of 3 mm to 4 mm. The protrusion of the fastening eye 12 contains blunt protruding teeth or spherical depressions that prevent the movement of the upper part of the port.

LID

The lower surface of cover 2 comprises a cylindrical projection (in the preferred embodiment, the cylindrical projection has a diameter of 14 mm and forms a cavity with a diameter of 12 mm); on the lower outer surface of the cylindrical projection, diametrically located petal-protrusions 13 are formed, directed in opposite directions from the center. In the preferred embodiment, the outer diameter of projections 13 is 17 mm, the thickness is 1 mm, and the width is 11 mm. In the preferred embodiment, cover 2 has the shape of a regular hexagon with a height of 2 mm, and a through hole with a diameter of 8 mm is located in the center of cover 2. This shape allows for convenient attachment of cover 2 to housing 1 without hand tools.

Cover 2 is inserted into housing 1 by its outer tabs-protrusions 13 into the grooves formed by the inner tabs-protrusions of the housing cavity. Cover 2 and housing 1 are pressed against each other, clamping gasket 6. By rotating cover 2 by 90 degrees, cover 2 is fixed in housing 1 by means of outer tabs-protrusions 13 of cover 2 and inner tabs-protrusions of the housing cavity 1. Such fixation ensures quick (compression and rotation by 90°), reliable and hermetically sealed fastening of cover 2 to housing 1 due to the elastic properties of silicone gasket 6 without the use of any adhesive coatings or sealing or adhesive lubricants. This fixation also ensures the possibility of simple (compression and rotation by 90°) removal of the cover 2, but does not allow accidental disconnection during implantation, since it requires significant efforts to overcome the elastic forces arising in the silicone gasket 6.

UNION

The nozzle 3 is designed as a tube with technological thickenings and depressions; in the preferred embodiment, the tube is made with a diameter of 2 mm. The distal end of the nozzle 3 is connected to the housing 1 by a threaded connection through a silicone gasket 7, and the proximal end of the nozzle 3 has a conical shape. In the preferred embodiment, the nozzle 3 is installed at an angle to the housing 1, which allows for thinner walls of the housing 1, providing a sufficient number of threads for attaching the nozzle 3, and accordingly reducing the weight and size of the port. In the middle part of the nozzle 3, there is a thread 15 or a circumferential depression in the form of a torus 16 for a "radial" spring 8 or conical depressions 17 for an elastic coupling, depending on the design.

The nozzle 3 can be designed with the possibility of installing the distal end 22 of the catheter tube 10, which can have a smooth corrugated shape with cutting marks every 4 mm in the area of the larger diameter.

The nozzle 3 can be designed with the possibility of installing the distal end of the catheter tube 10, which can have a constant homogeneous diameter with cutting marks every 15 mm.

A microvalve can be installed in the nozzle 3, designed with the possibility of activation when the inlet pressure exceeds 3 atm.

CLAMP CAP AND CATHETER TUBE

The clamping cap 4 has the shape of a sleeve with a knurled outer surface with a cavity 19 for mounting onto the fitting 3 and a through narrowed opening 20 (2 mm in diameter) for mounting the catheter tube 10 and clamping it onto the fitting 3. In this case, in the cavity 19 of the clamping cap 4, a thread or a circumferential recess in the form of a torus for a "radial" spring or a conical projection 18 for elastic coupling with the fitting 3 is formed, depending on the design. Such fixation ensures a reliable and hermetic connection of the catheter tube 10 pulled onto the fitting 3 by clamping a piece of the tube between the conical shape of the fitting 3 and the narrowed opening of the clamping cap 4.

Catheter tube 10 is an elastic flexible tube with an outer diameter of 2 mm and markings every 8-10 mm along one-third of the catheter tube's length on the distal and proximal sides. The total length of catheter tube 10 can reach 500 mm. Distal end 22 of catheter tube 10 can have a smooth corrugated shape with a 4 mm pitch, with cutting marks 21 every 4 mm in the region of the larger diameter. The proximal end of catheter tube 10 can have a constant, homogeneous diameter, with cutting marks every 15 mm. The cut corrugation in the area of the larger diameter allows for the unimpeded installation of the catheter tube 10 on the nipple 3 of the infusion port, thanks to the conical expansion, and is well installed due to the elasticity of the catheter tube 10 and is fixed in the narrowed opening 20 of the clamp cap 4. The corrugated distal section of the catheter tube 10 and the straight proximal section of the catheter tube 10 allow for the selection of the required length for implantation of the catheter and installation on the port. The distal end 22 of the catheter tube 10 is inserted into the narrowed opening 20 of the clamping cap 4. Due to the elasticity of the catheter tube 10, the clamping cap 4 moves freely in the proximal direction (along the arrow), compressing the oval projections 23 and is fixed in the oval depressions 25 between the oval projections of the catheter tube 10. Having determined a sufficient length of the catheter, the excess portion of the distal edge of the catheter is cut off along the cutting mark 21. As a result, only the conical expansion of half of the oval expansion of the catheter tube 10 remains in the clamping cap 4. Then the clamping cap 4 is shifted to the most distal conical expansion 24 of the catheter tube 10. As a result, the narrowed opening 20 of the clamping cap 4 is located between the adjacent conical expansions 24. Then the clamping cap 4 with the catheter tube 10 installed on it is mounted on the fitting 3 of the port. The narrowest edge 9 of the fitting 3 enters the conical expansion 24 of the distal edge of the catheter tube 10 without any obstacles due to the fact that the edge 9 of the fitting 3 is smaller than the diameter of the conical expansion 24 of the catheter tube 10. Then, with the counter-directed movement of the port and the clamping cap 4, the fitting 3 will move deeper into the catheter tube 10 until the groove of the clamping cap 4 snaps onto the spring 8 installed in the groove 16 of the expanded part of the fitting 3 of the port. In this way, the catheter tube 10 will be securely clamped between the conically expanding nozzle 3 and the narrowed opening 20 of the clamping cap 4, creating a compression of the wall of the catheter tube 10 between the clamping cap 4 and the nozzle 3. A similar principle of squeezing the catheter tube 10 between the clamping cap 4 and the nozzle 3 is also carried out when making a catheter without oval expansions, only due to the tolerance in the direction of decreasing the narrowed opening 20 of the clamping cap 4, since the narrowed opening 20 of the clamping cap 4 will be smaller than the diameter of the elastic catheter tube 10 (by the tolerance size), compressed under the action of constriction when putting the clamping cap 4 on the catheter tube 10.

The distal end of the straight catheter tube 10, as well as the proximal end, can have a constant homogeneous diameter with cutting marks 21 every 5 mm. The catheter tube 10 has one thick mark at a distance of 50 mm from the proximal end of the catheter tube 10, for visual indication of the lengths of the distal and proximal parts of the catheter tube 10. The elasticity of the catheter tube 10 and the chamfer 26 at the entrance of the clamping cap 4 allow easy insertion of the distal end of the catheter tube 10 with a small chamfer at the end 27 into the narrowed opening 20 of the clamping cap 4. The elasticity of the catheter tube 10 and the narrowed opening 20 of the clamping cap 4 ensure unimpeded movement of the clamping cap 4 along the length of the catheter tube 10 for the purpose of subsequent cutting off the excess length of the catheter tube 10 before installing it on the port nipple 3. Due to the elasticity of the catheter tube 10, it is fixed in the narrowed opening 20 of the clamping cap 4. The thick mark and marks on the straight distal and proximal sections of the catheter tube 10 allow you to easily select the required length for implantation of the catheter and installation on the port.

MEMBRANE

The membrane 5 is cylindrical and may consist of one or more cylindrical elements made of an elastomeric material, such as silicone rubber, which is readily permeable to hypodermic needles. Elastomers such as silicone rubber, natural rubber, synthetic rubber, butadiene rubber, chloroprene rubber, and urethane rubber, as well as composite materials formed by a three-dimensional combination of chemically dissimilar elements with various elastic-plastic and viscoplastic properties (e.g., elasticity coefficient, Poisson's ratio, viscosity, and others), can be used as materials. A combination of different membrane layers 5 with different viscoplastic and viscoelastic properties can provide improved self-healing properties after a puncture. For example, materials with different Poisson's ratios can provide an optimal combination of transverse compaction of membrane 5 in response to longitudinal compression, while materials with different creep properties can provide faster, but weaker, self-healing of some layers while supporting the self-healing of other, slow-creeping, but dense layers. Inclusions of pseudoelastic and thixotropic materials within membrane 5 with an elastomeric shell allow the membrane to liquefy upon mechanical puncture and re-condense at rest. Each of these elements can be manufactured as a single body using injection molding or cutting and turning methods from an elastomeric blank. The membrane 5 is clamped between the cover 2 and the housing 1. The distance between the cover 2 and the upper stage of the housing 1 ensures that the membrane is compressed sufficiently to self-heal after a puncture (about 20% for a one-component cylindrical silicone membrane 5) and to ensure that the port is impermeable to fluid under pressure between the cover 2, the membrane 5 and the housing 1.

A tight connection between the joint of body 1 and cover 2 is ensured by gasket 6, made in the form of a ring made of elastomer with good elastic properties, which performs the function of spacer of body 1 and cover 2 and additional sealing of the port body along the contour.

In this particular embodiment, the membrane 5 and the housing gasket 6 are made in the form of a single-piece structure.

Although ports are currently single-use medical devices, the proposed design of the coupling of cover 2 and body 1 via a compressed gasket 6 and membrane 5 allows for the repeated use of body 1, cover 2, and other metal port components, provided they are cleaned, disinfected, and sterilized individually. The exception is punctured or damaged membranes, which must be replaced after extended use. The simple, hermetically sealed coupling of cover 2 to body 1, with a simple hand movement, allows for this to be performed directly in the operating room by a practicing physician.

ASSEMBLY AND INSTALLATION OF THE PORT

A membrane 5 is inserted into the inner cavity of the cover 2, and a gasket 6 of the housing 1 is placed on the cylindrical projection. The cover 2 is inserted into the housing 1 with its outer projections 13 of the cylinder in the grooves formed by the inner projections of the cavity of the housing 1. The cover 2 and the housing 1 are pressed against each other, clamping the gasket 6. By turning the cover 2 by 90 degrees, the cover is fixed in the housing 1 with the help of the outer projections 13 of the cylinder of the cover 2 and the inner projections of the cavity of the housing 1. The fitting 3 is screwed into the side opening of the housing 1, while the gasket 7 of the fitting 3 is clamped between them. In the case of a threaded connection (without a tool): the catheter tube 10 is threaded through the narrowed opening 20 of the clamping cap 4 and with its help is placed on the conical end of the fitting 3, while due to the elasticity of the catheter tube 10, its outer diameter increases. Thus, in the case of a threaded connection, as a result of screwing the clamping cap 4 onto the fitting 3, the catheter tube 10 is fixed on the conical expansion of the fitting 3 by the narrowed opening 20 of the clamping cap 4.

INSTALLATION using hand tools

The clamp cap 4 is installed on the port fitting 3 using a hand tool consisting of an L-shaped stop and a movable Z-shaped handle, which actuates the slider 29, thereby compressing the port and clamp cap 4, simply by squeezing the handle. Clamp cap 4 with catheter tube 10 is installed in groove 30 of the lower (movable) slider 29 of the hand tool. The clamping cap 4 has a groove on the inner surface for reliable engagement with the spring ring 8. The clamping cap 4 with the catheter tube 10 as a result of the coaxiality ensured by the coaxiality of the groove 30 of the slider 29 and the groove of the support, as well as the narrowed opening 20 of the clamping cap 4, freely pulls the catheter tube 10 onto the fitting 3, tightly clamping the edge 28 of the conical expansion 24 of the distal end of the catheter tube 10 due to the elasticity of the material of the catheter tube 10 and the narrowed opening 20 of the clamping cap 4. Further, with the counter-directed movement of the implantable infusion port and the clamping cap 4, the fitting 3 will move deeper in the catheter tube 10 until the groove of the clamping cap 4 snaps onto the spring 8 installed in the groove 16 of the expanded part fitting 3 of the implanted infusion port. In this way, the catheter tube 10 will be securely clamped between the conically expanding fitting 3 and the narrowed opening 20 of the clamping cap 4, creating a compression of the wall of the catheter tube 10 between the clamping cap 4 and the fitting 3. A similar principle of clamping the catheter tube between the clamping cap 4 and the fitting 3 is also implemented when the clamping cap 4 is designed with a thread and when the hand tool is designed with the function of screwing the clamping cap 4 onto the fitting 3.

After infiltration anesthesia, a puncture of the internal jugular vein is performed under ultrasound guidance. A metal J-shaped guidewire, 80 cm long, is inserted through the needle lumen. A bougie with an introducer sheath is passed over the guidewire into the vessel lumen, then the bougie is removed from the introducer sheath. A 2.0-4.0 cm long skin incision is made in the subclavian region, parallel to the clavicle, 1.5-2.0 cm from the clavicle. Then, using blunt forceps and scissors, the tissue is separated, creating a pocket for subsequent implantation of the infusion port. Using a metal bougie, a tunnel is created between the subcutaneous fat and the superficial fascia of the subclavian region and neck from the incision to the vein puncture site. A catheter is advanced through the tunnel using the same metal bougie.

A catheter is then inserted through the introducer into the superior vena cava under X-ray control, and the catheter is flushed with saline. The introducer is removed from the vein. A hand tool is attached to the end of the catheter tube 10, which has been brought into the pocket. The required length of catheter tube 10 is selected, and the remaining portion is trimmed using the tool's blades. Clamp cap 4 with catheter tube 10 is installed in the groove of the lower (movable) slider 29 of the hand tool (the connector is designed for connection using a ring spring with a hand tool, or for connection using an elastic coupling with a hand tool, or by screwing the clamp cap onto the connector of the implanted infusion port). The upper projection of the hand instrument support rests with a groove against the cylindrical projection of the nozzle 3. By simply squeezing the handle of the hand instrument towards the support, the catheter tube 10 is placed on the conical, smoothly tapering end of the nozzle 3, whereby the outer diameter increases due to the elasticity of the catheter tube 10. Thus, as a result of squeezing, the catheter tube 10 is fixed on the nozzle 3 by the narrowed opening 20 of the clamp cap 4 on the conical expansion of the nozzle 3. The port with the installed catheter tube 10 is inserted into the incision site. The implanted infusion port rests with its ear 12 against the biological tissue. The projection of ear 12 prevents longitudinal mobility of the port under the skin without the need to suture the outermost ear 12. The implanted infusion port is sutured to the biological tissue with two ears 11.

A female Russian Chinchilla rabbit weighing 3 kg was observed at Smolensk State Medical University. The animal had no history of chronic diseases. It had previously undergone an experimental thermal venous obliteration procedure, which it tolerated well. Ultrasound examination revealed no pathological changes. After catheter placement, a 1.5-3 cm skin incision was made to create a subcutaneous pocket. An implantable infusion port of the proposed design was inserted into the pocket and secured to the adjacent tissues with separate sutures using two easily accessible tabs (11) in the pocket between the tissue and skin, eliminating the need for additional fixation using tab (12). The skin incision was sutured layer by layer. At all stages, and especially before the end of implantation, the patency of the catheter and infusion port was monitored by injecting heparin into the venous system using a Huber needle. After 14 days of procedures performed through the installed catheter, no complications were observed. The test animal tolerated port removal well.

Claims (10)

1. An implantable infusion port comprising a housing with a cavity for a fluid connected to a nozzle located on the side of the housing, a cover, a membrane hermetically clamped between the cover and the housing, made of a material permeable to the needle, the cover is made with a through hole, and on the outer surface of the housing there are fastening ears located at an angle of 120 degrees with respect to each other, characterized in that it contains a clamping cap with a cavity for installation on the nozzle and a through hole for installing and clamping a catheter tube on the nozzle, the cover is configured to provide access to the membrane and on the lower surface it contains a cylindrical protrusion, on the lower outer surface of the cylindrical protrusion there are diametrically located petal-protrusions, on the upper inner cylindrical surface of the housing there are diametrically located petal-protrusions, while the cover is configured to be fixed in the housing by turning the cover by 90 degrees, between the upper outer surface of the housing and the lower surface of the cover there is installed the housing gasket, the membrane is installed in the internal cavity of the cylindrical projection of the cover, the fastening eye, located on the side of the housing diametrically opposite the fitting, is made trapezoidal in shape with a projection bending towards the bottom of the port and tapering towards the axis of symmetry of the housing with a bending radius of 3 mm to 4 mm. 2. An implantable infusion port according to claim 1, characterized in that the membrane has the shape of a cylinder consisting of one cylindrical element or cylindrical elements made of an elastomeric material. 3. An implantable infusion port according to claim 1, characterized in that the projection of the fastening ear contains non-sharp protruding teeth or spherical depressions. 4. An implantable infusion port according to claim 1, characterized in that the cavity for the fluid medium in the housing is made stepped, and the housing is made of titanium or a titanium plate is installed on the bottom of the housing. 5. An implantable infusion port according to claim 1, characterized in that a through hole is made in the center of the cover. 6. An implantable infusion port according to claim 1, characterized in that the distal end of the nozzle is connected to the housing by a threaded connection through a silicone gasket, the proximal end of the nozzle has a conical shape, and the nozzle is installed at an angle to the housing. 7. An implantable infusion port according to claim 1, characterized in that the nozzle is made in the form of a tube with technological thickenings and depressions, and in the cavity of the clamping cap there is a thread or a circumferential depression in the form of a torus for a “radial” spring or a conical protrusion for elastic coupling with the nozzle. 8. An implantable infusion port according to claim 1, characterized in that the nozzle is designed with the possibility of installing the distal end of a catheter tube having a smooth corrugated shape with cutting marks every 4 mm in the area of the larger diameter. 9. An implantable infusion port according to claim 1, characterized in that the nozzle is designed with the possibility of installing the distal end of a catheter tube having a constant homogeneous diameter with cutting marks every 15 mm. 10. An implantable infusion port according to claim 1, characterized in that a microvalve is installed in the nozzle, designed with the possibility of activation when the inlet pressure exceeds 3 atm.