RU2716331C1 - Device for blood sampling and separation into components - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: device, made in the form of a syringe, comprising a hollow cylindrical body equipped with a neck-cannula at one end and open from the opposite end, a piston installed inside the housing with possibility of reciprocal movement, detachable rod connected by threaded connection with piston and coming out from open side of housing, on neck-cannula of housing there is threaded connection "luer-lock" and injection needle is installed with cannula, outer surface of housing is made without protruding elements, open end of the housing comprises a piston blocking means preventing the piston free discharge from the housing, the housing has a scale in milliliters to control the body filling volume, characterized in that the detachable rod is connected to the piston through the pin through the "luer-lock" threaded connection, pin is connected with piston with possibility of removal and has internal thread "luer-lock", end of stem has external thread "luer-lock", injection needle is made in form of a butterfly needle with catheter and cannula, inner volume of syringe to be filled, ranges from 20 to 50 ml.

EFFECT: devices for blood sampling and separation into components.

1 cl, 12 dwg

Description

The field of technology.

The technical solution relates to medical devices, is intended for blood sampling and its separation into components in a centrifuge, in order to obtain concentrates consisting of blood cells.

The prior art.

A device for the extraction and production of blood plasma and / or fat (source [1]: patent EP2666487, 11.27.2013.). The device comprises a syringe formed from a hollow cylindrical body, a piston and a rod. On the throat-cannula of the syringe, a luer-lock threaded connection is made for attaching a hollow needle to the cannula or a tight closing cap; on the opposite side, the cylindrical body is open. A piston is placed in the cylindrical body to move inside the cylindrical body, which has a rod extending through the open side of the cylindrical body. The piston and the rod are connected, with the possibility of separation, by means of a screw connection (threaded connection). The end of the stem with an external thread is screwed into a piston having a recess with an internal thread. The cylindrical body on the side of the rod is made smooth, without protruding elements, which allows you to install it in a centrifuge with the neck-cannula up.

In the device [1], the piston and the rod are connected, with the possibility of separation, by screw connection, the end of the rod is made with an external thread, and the piston has a recess with an internal thread. A threaded luer-lock connection is made on the neck of the syringe for needle attachment. Thus, the threaded rod / piston and neck-cannula / needle connections are structurally different from each other, which complicates the production due to the need to perform different types of threaded connections. The execution of the internal thread in the piston complicates its design and does not allow the use of standard pistons made without internal threads, for example from syringes, the production technology of which has already been debugged, in the design of the device. In addition, the design of the device [1] does not contain means for holding the piston in the cylindrical body of the syringe, which can lead to its depressurization in a centrifuge under the influence of centrifugal forces. In the device [1] a tubular needle with a cannula is used, it does not allow taking blood sampling away from the venipuncture area, and increases the risk of damage to the vein as a result of unintentional needle displacement. The volume of the cylindrical body is not suitable for taking the necessary amount of blood from which the required amount of platelet-rich plasma can be separated for various medical procedures.

Known syringe flask for plasma rich in platelets (source [2]: patent RU184978, 11/15/2018). The syringe flask contains a hollow cylindrical body, a piston mounted in the body, a removable stem connected to the piston, a cannula neck equipped with a luer-lock threaded fastener for connecting an injection needle, a sealed cap and an adapter for another syringe, as well as a locking means piston, preventing the piston from exiting the housing. In this case, the outer surface of the end of the housing from the side of the pusher is made smooth without protruding wings. The piston contains a rubber housing, as well as a mount for the removable rod. Fastening is carried out by means of a threaded connection, in which the piston has a pin with an external thread, and the pusher has a hole with a mating internal thread.

In the device [2], the piston and the removable rod are connected, with the possibility of separation, by means of a threaded connection in which the piston has a pin with an external thread and a pusher a hole with a reciprocal internal thread. A threaded connection “luer-lock” is made on the neck-cannula of the syringe for attaching the injection needle. Thus, the threaded rod-piston and neck-cannula / needle threaded connections are structurally different from each other, which complicates the production due to the need to perform different types of threaded connections. The piston has a pin with an external thread, the stem has a recess with an internal thread. The pin is a non-standard product. The parameters of the pin thread and the internal thread of the rod do not correspond to the luer-lock threaded connection, which complicates the production technology due to the need to make several original connections in one device. The threaded connection of the rod and the piston pin does not provide centering of the rod when screwing on, which can lead to distortion of the rod or jamming. The device [2] uses a tubular injection needle with a cannula, it does not allow blood collection to take away from the area of venipuncture, and increases the risk of damage to the vein as a result of unintentional needle displacement. The volume of the cylindrical body does not allow taking from 20 to 50 ml of blood from a patient in one approach, this is the minimum amount of blood from which the required amount of plasma enriched with platelets can be separated enough for most medical procedures.

Thus, the known devices [1; 2] have common shortcomings and lead to related problems: the use of various types of threaded connections leads to a complication of production technology and an increase in the cost of the product; the used threaded connections for connecting the piston and the rod do not provide centering of the rod and allow it to be skewed when screwing; the injection needle used is traumatic; the volume of blood taken by devices [1; 2] does not allow to obtain the required amount of blood components after its separation in one approach.

The objective of the invention is to develop a device for the collection and separation of blood into components devoid of disadvantages inherent in analogues.

The technical result of the invention is to enable safe collection of the required blood volume and its separation into components in a centrifuge, a structurally simple and technologically advanced device with uniform types of threaded connections.

The technical result is achieved in that the device for collecting and separating blood into components is made in the form of a syringe containing a hollow cylindrical body, equipped with a neck-cannula at one end and open at the opposite end, a piston mounted inside the body with the possibility of reciprocating movement, removable the rod is connected by a threaded connection to the piston and exiting from the open side of the housing; on the throat-cannula of the housing a threaded connection “luer-lock” is made and an injection needle with a cannula is installed th, the outer surface of the housing is made without protruding elements, the open end of the housing contains a means for blocking the piston, preventing the free exit of the piston from the housing. It is characterized in that the removable stem is connected to the piston through a pin, by means of a luer-lock threaded connection, the pin is removably connected to the piston and has an internal luer-lock thread, an external luer-lock thread is made at the end of the stem , the injection needle is made in the form of a butterfly needle with a catheter and cannula, the internal volume of the syringe to be filled is from 20 to 50 ml.

The specified entity ensures the achievement of the claimed technical result. The safety of blood sampling is ensured through the use of a butterfly needle with a luer-lock catheter and cannula, use of a cannula and a body, a piston and a rod, a luer-lock threaded connection, and local narrowing of the body from the open end. The necessary amount of blood is taken by using a syringe with an internal volume of 20 to 50 ml. The volume of the final product depends on the volume of the syringe, and the required volume of the final product, in turn, depends on the planned manipulation (injection, application) and the injection site. The separation of blood into components in a centrifuge is provided by the ability to remove the removable rod when installing the device in a centrifuge and the smooth shape of a cylindrical body. The manufacturability of the device is ensured by the use of the uniform luer-lock threaded connections in the device for connecting the cannula and the body, the piston and the rod.

It is envisaged that a scale in milliliters is made on the housing to control the filling volume of the housing, and the piston lock means is made in the form of local narrowing of the housing from the open end.

The invention is illustrated by graphic materials:

Figure 1 - General view of the device, with a volume of 20 ml, 3d model;

Figure 2 - General view of the device, with a volume of 20 ml, with spaced parts, 3d model;

Figure 3 - view of the device, an option with a volume of 20 ml, in longitudinal section, 3d model;

Figure 4 - General view of the device, an option with a volume of 50 ml, 3d model;

Figure 5 - General view of the device, an option with a volume of 20 ml, 3d model;

6 is a General view of the device, an option with a volume of 20 ml, with spaced parts, 3d model;

Fig.7 is a view of the device, an option with a volume of 20 ml, in longitudinal section, 3d model;

Fig - a General view of the device, a variant with a volume of 50 ml, 3d model;

Fig.9 is a photograph of the layout of the device,

Figure 10 - pin layout device, photograph;

11 - stock layout device, photograph;

Fig - rod Assembly with the piston of the device layout, photograph.

Specification:

1 - case;

2 - the piston;

3 - stock;

4 - pin;

5 - neck-cannula;

6 - threaded connection "luer-lock";

7 - internal thread "luer-lock" ("mother");

8 - external thread "luer-lock" ("father");

9 - threaded connection "luer-lock" of the rod and pin;

10 - injection butterfly needle;

11 - catheter;

12 - cannula;

13 - scale;

14 - means of blocking;

15 - bead;

16 - seat.

Implementation of a technical solution.

Example 1. A device for collecting and separating blood into components is made in the form of a syringe with an internal usable volume of 20 ml. The device comprises a hollow cylindrical body 1 (Fig. 1; 2; 3), a piston 2 (Fig. 1; 2; 3), a rod 3 (Fig. 1; 2; 3), a pin 4 (Fig. 1; 2; 3 ) Case 1, stem 3, pin 4 are made of plastic. The housing 1 is made visually transparent. The piston 2 is made of an elastic material, a rubber compound. The housing 1 at one end is equipped with a neck-cannula 5 (Fig. 1; 2; 3), from the opposite end the housing 1 is open. The outer surface of the housing 1 is made without protruding elements, the open end of the housing 1 contains a means of blocking 14 (Fig.3) of the piston 2, preventing the free exit of the piston 2 from the housing 1. The locking means 14 of the piston 1 is made in the form of local narrowing of the housing 1 made from the open side the end of the housing 1. The piston 2 is mounted inside the housing 1 with the possibility of reciprocating motion through the rod 3. The internal cavity of the housing 1 is coated with silicone grease. The rod 3 leaves the open end of the housing 1. The rod 3 is removable, connected through a pin 4 to the piston 2 with a threaded connection “luer-lock” 6 (Fig. 1; 2; 3). To ensure the connection of the piston 2 and the rod 3, the pin 4 is removably mounted in the piston 2. The pin 4 has an internal luer-lock 7 thread (Fig. 1; 2; 3) (“mother”) and a shoulder 15 (FIG. 2; 3) for connection with the piston 2. At the end of the rod 3, an external thread “luer-lock” 8 (Fig. 1; 2; 3) (“male”) is made. On the throat-cannula 5 of the housing 1, a threaded connection "luer-lock" 9 (Fig. 1; 2; 3) is made and an injection butterfly needle 10 (Fig. 1; 2; 3) is installed with a catheter 11 (Fig. 1; 2 ; 3) and cannula 12 (Fig. 1; 2; 3). On the housing 1, a scale 13 (Fig. 1; 2; 3) is made, black, graduated in milliliters to control the filling volume of the housing 1. The device is a sterile product; therefore, the butterfly injection needle 10 is installed by cannula 12 on the neck-cannula 5 of housing 1 and closed with a cap (not shown) thereby eliminating the ingress of packaging paper fibers on the parts of the syringe and butterfly needle 10.

Example 2. A device for collecting and separating blood into components is made in the form of a syringe with an internal usable volume of 50 ml. The device comprises a hollow cylindrical body 1 (Fig. 4), a piston 2 (Fig. 4), a rod 3 (Fig. 4), a pin 4 (Fig. 4). Case 1, stem 3, pin 4 are made of plastic. The housing 1 is made visually transparent. The piston 2 is made of an elastic material, a rubber compound. The housing 1 at one end is equipped with a neck-cannula 5 (figure 4), from the opposite end the housing 1 is open. The outer surface of the housing 1 is made without protruding elements, the open end of the housing 1 contains a means of blocking 14 (Fig. 4) of the piston 2, preventing the free exit of the piston 2 from the housing 1. The locking means 14 of the piston 1 is made in the form of local narrowing of the housing 1 made from the open side the end of the housing 1. The piston 2 is mounted inside the housing 1 with the possibility of reciprocating motion through the rod 3. The internal cavity of the housing 1 is coated with silicone grease. The rod 3 extends from the open end of the housing 1. The rod 3 is removable, connected, through a pin 4, to the piston 2 with a threaded connection “luer-lock” 6 (Fig. 4). To ensure the connection of the piston 2 and the rod 3, the pin 4 is removably mounted in the piston 2. The pin 4 has an internal thread “luer-lock” 7 (figure 3) (“mother”) and a shoulder 15 (figure 3) for connection with a piston. At the end of the rod 3, an external thread "luer-lock" 8 (Fig.3) ("father") is made. On the neck-cannula 5 of the housing 1, a threaded connection “luer-lock” 9 (Fig. 4) is made and an injection butterfly needle 10 (Fig. 4) with a catheter 11 (Fig. 4) and a cannula 12 (Fig. 4) are installed. On the housing 1, a scale 13 (Fig. 4) is made, black in milliliters, to control the filling volume of the housing 1. The device is a sterile product, therefore, the butterfly injection needle 10 is installed by the cannula 12 on the neck-cannula 5 of the housing 1 and is closed with a cap (not shown) thereby eliminating the ingress of packaging paper fibers on the parts of the syringe and the butterfly needle 10.

Example 3. A device for collecting and separating blood into components is made in the form of a syringe with an internal usable volume of 20 ml. The device comprises a hollow cylindrical body 1 (Fig. 5; 6; 7), a piston 2 (Fig. 5; 6; 7), a rod 3 (Fig. 5; 6; 7), a pin 4 (Fig. 5; 6; 7 ) Case 1, stem 3, pin 4 are made of plastic. The housing 1 is made visually transparent. The piston 2 is made in the form of an annular cuff mounted on the pin 4. The rod 3 is connected to the pin 4 with the possibility of separation. The housing 1 from one end is equipped with a neck-cannula 5 (Fig. 5; 6; 7), from the opposite end the housing 1 is open. The outer surface of the housing 1 is made without protruding elements, the open end of the housing 1 contains locking means 14 (Fig. 5; 6; 7), a piston 2, which prevents the piston 2 from freely leaving the housing 1. The locking means 14 of the piston 1 is made in the form of a local narrowing of the housing 1 made from the open end of the housing 1. The piston 2 is mounted inside the housing 1 with the possibility of reciprocating motion on the pin 4 by means of the rod 3. The internal cavity of the housing 1 is coated with silicone grease. The rod 3 leaves the open end of the housing 1. The rod 3 is removable, connected to the pin 4 with a threaded connection “luer-lock” 6 (Fig. 5; 6; 7). The pin 4 has an internal thread "luer-lock" 7 (Fig.5; 6; 7) ("mother") and a seat 16 (Fig.6; 7) under the piston 2. At the end of the rod 3, an external thread "luer- lock "8 (Fig. 5; 6; 7) (" dad "). On the neck-cannula 5 of the housing 1, a threaded connection “luer-lock” 9 (Fig. 5; 6; 7) is made and an injection butterfly needle 10 (Fig. 5; 6; 7) with a catheter 11 (Fig. 5; 6 is installed) ; 7) and cannula 12 (Fig. 5; 6; 7). On the housing 1, a scale 13 (Fig. 5; 6; 7) is made, black, graduated in milliliters to control the filling volume of the housing 1. The device is a sterile product, therefore, the butterfly injection needle 10 is installed by cannula 12 on the neck-cannula 5 of housing 1 and closed with a cap (not shown) thereby eliminating the ingress of packaging paper fibers on the parts of the syringe and butterfly needle 10.

Example 4. A device for collecting and separating blood into components is made in the form of a syringe with an internal useful volume of 50 ml. The device comprises a hollow cylindrical body 1 (Fig. 8), a piston 2 (Fig. 8), a rod 3 (Fig. 8), a pin 4 (Fig. 8). Case 1, stem 3, pin 4 are made of polypropylene. The housing 1 is made visually transparent, so that it is possible to control the process of blood sampling and its separation into components after a centrifuge. The piston 2 is made of elastic material, latex, in the form of an annular cuff mounted on the pin 4. The housing 1 is equipped at one end with a neck-cannula 5 (Fig. 8), the housing 1 is open from the opposite end. The outer surface of the housing 1 is made without protruding elements, the open end of the housing 1 contains means for blocking the piston 2, which prevents the free exit of the piston 2 from the housing 1. The piston 2 is mounted inside the housing 1 with the possibility of reciprocating movement through the rod 3. The outer surface of the piston 2 and the internal cavity of the housing 1 is coated with silicone grease. The rod 3 extends from the open end of the housing 1. The rod 3 is removable, connected to the piston 2 with a threaded connection “luer-lock” 6 (Fig. 8) The pin 4 has an internal thread “luer-lock” 7 (Fig. 6; 7) and a seat place 16 (Fig. 6; 7) under the piston 2. At the end of the rod 3, an external thread "luer-lock" 8 (Fig. 6; 7) is made. A threaded connection “luer-lock” 9 (Fig. 8) is made on the throat-cannula 5 of the housing 1 and an injection butterfly needle 10 (Fig. 8) with a catheter 11 (Fig. 8) and a cannula 12 (Fig. 8) is installed. On the housing 1, a scale 13 is made (Fig. 8), contrasted in black, graded in milliliters to control the filling volume of the housing 1. The locking means 14 (Fig. 8) of the piston 1 is made in the form of local narrowing of the housing 1 made from the open end of the housing 1. The device is a sterile product, therefore, the butterfly injection needle 10 is installed by the cannula 12 on the neck-cannula 5 of the housing 1 and is closed by a cap (not shown), thereby preventing the fibers of the packing paper from getting on the parts of the syringe and butterfly needle 10. Butterfly needle and 10 has a transparent soft catheter 11 made of polyvinyl chloride 30 cm long.

Example 5. Visual layout of the device.

A device for collecting and separating blood into components is made in the form of a syringe with an internal useful volume of 10 ml. The device comprises a hollow cylindrical body 1 (Fig. 9), a piston 2 (Fig. 9; 12), a rod 3 (Fig. 9; 11), a pin 4 (Fig. 9; 10). Case 1, stem 3, pin 4 are made of plastic. The housing 1 is made visually transparent. The piston 2 is made of an elastic material, a rubber compound. The housing 1 at one end is equipped with a neck-cannula 5 (Fig.9), from the opposite end the housing 1 is open. The outer surface of the housing 1 is made without protruding elements, the open end of the housing 1 contains a means for blocking (not indicated in Fig. 9) the piston 2, which prevents the free exit of the piston 2 from the housing 1. The locking means of the piston 1 is made in the form of local narrowing of the housing 1 made from the side the open end of the housing 1. The piston 2 is mounted inside the housing 1 with the possibility of reciprocating motion through the rod 3. The internal cavity of the housing 1 is coated with silicone grease. The rod 3 leaves the open end of the housing 1. The rod 3 is removable, connected through a pin 4 to the piston 2 with a threaded connection “luer-lock” 6 (Fig.11). To ensure the connection of the piston 2 and the rod 3, a pin 4 is mounted in the piston 2 with the possibility of removal. The pin 4 has an internal thread “luer-lock” 7 (figure 10) (“mother”) and a shoulder 15 (figure 10) for connection with the piston 2 (Fig.12). At the end of the rod 3, an external thread "luer-lock" 8 (Fig.11) ("father") is made. A threaded connection “luer-lock” 9 (Fig. 9) is made on the throat-cannula 5 of the housing 1 and an injection butterfly needle 10 (not shown in FIG. 9) with a catheter 11 (not shown in FIG. 9) and a cannula 12 are installed (not shown in FIG. 9). On the housing 1, a scale 13 is made (Fig. 9), black, graduated in milliliters to control the volume of filling of the housing 1. The device is a sterile product, therefore, the butterfly injection needle 10 is installed by the cannula 12 on the neck-cannula 5 of the housing 1 and is closed with a cap (not shown) thereby eliminating the ingress of the fibers of the packaging paper on the parts of the syringe and the butterfly needle 10.

Use of the invention.

To obtain the necessary blood components, for example, platelet rich PRP plasma, stepwise centrifugation is used. Blood sampling is performed with the addition of an anticoagulant (dextrose A citrate, sodium citrate) to prevent platelet activation. Before blood sampling, 1.5 ml ... 2 ml of anticoagulant solution is collected into the device. Using a butterfly needle 10, a vein is punctured and blood is taken from the patient; for this, the piston 2 in the housing 1 is slowly moved by applying force to the outer end of the stem 3. Due to the dilution of air in the housing 1, blood enters the housing 1, fills to the required volume. The volume of blood drawn is visually monitored on a scale of 13. Upon reaching the extreme position of the piston 2, the blocking means 14 prevents the further movement of the piston 2. This ensures that the required blood volume is safely taken through the use of a butterfly needle 10 with a catheter 11 and a luer-lock cannula 12. The involuntary movements of the body 1 are not transmitted through the catheter 11 to the butterfly needle 10 and vein. The luer-lock 9 provides tightness. The butterfly needle 10 is removed from the vein, the luer-lock 12 cannula is removed from the neck-cannula 5 of the housing 1. Close the neck-cannula 5 with a sealed cap (not shown). The rod 3 is disconnected from the piston 2, holding the housing 1, loosen the luer-lock »6 threaded connection between the pin 4 and the rod 3. Thus, the housing 1 filled with blood becomes a cylindrical container suitable for installation directly in a centrifuge. The housing 1 is installed in a centrifuge and conduct the first separation. Under the influence of centrifugal force, blood cells are separated. After separation, blood in body 1 is stratified into fractions containing the following components: platelet suspension (PLT suspension) and red blood cells (RBC). Holding the housing 1 vertically remove it from the centrifuge. Connect the rod 3 to the piston 2, holding the housing 1, screw the luer-lock 6 threaded connection between the pin 4 and the rod 3. At the same time, the luer-lock 6 threaded connection allows the rod 3 to be centered and avoid distortion. After that, the necessary fraction with blood components (for example, platelet suspension) is taken from case 1 for second centrifugation and an increase in the concentration of necessary blood cells. For the second centrifugation, the second same device and adapter with the luer-lock connection are used. While holding the housing 1 in a vertical position, remove the cap and connect the housing 1 and the second device through an adapter (not shown) installing it on the neck-cannula 5 of the housing 1. Slowly move the necessary fraction (platelet suspension) from the housing 1 into the housing 1 of the second device. Then, the second centrifugation of the body 1 of the second device filled with the first fraction (platelet suspension) is similarly carried out, the rod 3 is first disconnected from the piston 2 and the cap is put on the neck-cannula 5. The housing 1 of the second device is installed in a centrifuge and a second separation is carried out. Under the action of centrifugal force, fraction separation (platelet suspension) occurs. After separation, blood in body 1 of the second device is stratified into fractions containing the following components: platelet-poor plasma (PPP), platelet-rich plasma (PRP). Holding the housing 1 of the second device in an upright position, set the rod 3 and remove the cap. Slowly move the required fraction (platelet-poor plasma (PPP)) from the housing; in housing 1, platelet-rich plasma (PRP) remains ready for use.

The device allows you to get a predicted increase in the concentration of necessary blood cells. Allows platelet suspension (PLT suspension), red blood cells (RBC), platelet-poor PPP plasma, platelet-rich plasma (PRP). The possibility of double centrifugation - allows you to concentrate cells in a smaller volume of the liquid part of the biomaterial and to obtain significantly higher cell concentrations in the final product. The total number of cells depends on the volume of material taken from the patient, and the device allows you to get a predicted increase in the concentration of these cells, depends on the volume of the removed part of the liquid fraction after the second centrifugation. The multiplicity of the increase in concentration is limited only by the volume of material taken initially from the patient.

Claims (2)

1. A device for collecting and separating blood into components, made in the form of a syringe containing a hollow cylindrical body, equipped with a neck-cannula at one end and open at the opposite end, a piston mounted inside the body with the possibility of reciprocating movement, a removable rod connected a threaded connection with a piston and extending from the open side of the housing, a threaded connection “luer-lock” is made on the throat-cannula of the housing and an injection needle with a cannula is installed, the outer surface of the housing is made on no protruding elements, the open end of the housing contains a piston blocking means that prevents the piston from freely exiting the housing, a scale in milliliters is made on the housing to control the filling volume of the housing, characterized in that the removable rod is connected to the piston via a pin through a luer-lock threaded connection ", The pin is removably connected to the piston and has an internal luer-lock thread, an external luer-lock thread is made at the end of the stem, the injection needle is made in the form of a butterfly needle with a catheter and cannula, internal s volume syringe intended for filling, is from 20 to 50 ml. 2. The device according to claim 1, characterized in that the piston blocking means is made in the form of local narrowing of the housing from the open end.

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