Field of the Invention

The present invention relates to a device and method for drawing separated substances from a tube, in a closed system. More particularly, the invention relates to a suction system that is provided with at least one syringe, which can be pre-assembled to the system or can be connected by the care-giver at the point of care, into which substances are drawn from a tube or other adequate container, in a sterile and isolated environment.

Background of the Invention

The separation of substances is a common necessity in many fields, such as medicine, cosmetics, materials engineering, etc. There are several known ways for separating different materials that are in the same mixture, but there is a difficulty in isolating each of the different materials separately, while keeping sterile conditions and avoiding contact with the environment during the process.

An example of such necessity is a cosmetic process, involving the injection of platelet-rich plasma (PRP) into the body of a patient. The PRP stimulates healing of bones and soft tissues, and rejuvenates the skin. The PRP is achieved by the combining of platelet and plasma, which both originate in blood, among other substances, such as red and white blood cells. PRP is used extensively in sport medicine, orthopedics, aesthetics, and as treatment for chronic injuries.

When platelets and plasma are each separated from other substances in the blood, a doctor can sometimes determine the desirable concentration of platelets in a PRP (some devices provide concentration management means, and others only allow suction of plasma and platelets, in their given concentration) , by mixing the platelets with the plasma accordingly.

Bone marrow cells can also be used for healing purposes, since bone marrow contains stem cells. A Bone Marrow Concentrate (BMC) is a mixture that contains stem cells and plasma. It is a mixture that is known to contribute to the healing and regeneration process.

Another example from the medicine field is a mixture of white blood cells and plasma. A high concentration of white blood cells is usually given to patients who suffer from a weak immune system, such as chemotherapy patients. A mixture comprising a high concentration of red blood cells can be used on a patient whose oxygen delivery is insufficient.

Although the following description refers mostly to the isolation of materials in the blood for the purpose of manufacturing a PRP/BMC mixture, the device and method can be applied to any other field where materials need to be separated from a mixture, especially when there is a need for a sterile process that allows no contact with external materials or no exposure to the environment.

One known way of separating materials in a mixture is by using a centrifuge. In this process, the materials are separated into layers, one above the other. The difficulty lies with the following step, which is the isolation of the separated materials, in different vessels, without any contact between the materials and the environment and/or without having the materials leaking out of the suction vessel after the extraction. Sterile conditions are necessary for providing uncontaminated extracted materials, especially when the materials are intended to be re-introduced into the human body. The vessels into which each of the separated layers is eventually contained can be of any suitable type, such as a syringe, a tube, a plate, and the like.

A device that provides sterile conditions (mostly with no contact with the environment), can be referred to as "a closed system". One advantage of a closed system is, for example, the lack of oxidation of the extracted materials. Nowadays, closed systems are used in the extraction process of materials in the medical and cosmetics fields, but there is a need for a device that will also prevent the materials from flowing back in the opposite direction, due to natural pressure regulation, or due to operational errors. If the materials will flow in the opposite direction they can be contaminated, when drawn back to the syringe (and create a pumping effect), Flow of materials in the opposite direction can also cause re-mix of the different layers, and cause the process to become inaccurate and eliminate the goal of achieving reproducible results.

In suction systems, fluids often flow in the opposite direction when suction is stopped. If, for example, materials flow from a syringe back into a tube that guides the materials into the syringe, the subsequent suction might introduce infectious materials from the inner walls of a syringe, which was "pumped" more than once, and the system will become unsterile.

Therefore, there is a need for a suction system that will operate as a closed system, and will also prevent materials from flowing in the opposite direction, due to a higher pressure inside the system, or by operator errors.

It is an object of the present invention to provide a device and method that overcome the drawbacks of the prior art. It is another object of the invention to provide a device and method that provide sterile conditions for a process of separating and isolating materials.

It is a further object of the invention to provide a device and method capable of safely and quickly drawing materials under emergency conditions, such as immediate medical care and under stressful conditions, with minimal possibility of errors.

Other objects and advantages of the invention will become apparent as the description proceeds.

Summary of the Invention

The invention relates to a device for drawing substances from a tube, comprising: a cover, at least one syringe, fluid transport elements, which are connected to one-way valves and a tube housing, wherein said tube housing is connected to said cover and comprises a needle, suitable to transport fluids, and wherein said fluid transport elements comprise a flow system and a flow- splitting element.

The flow system comprises separate pipes that are all connected to the flow-splitting element. The inlet of the flow-splitting element is connected to the needle and the outlet is connected to the flow system. The flow system comprises one or more pipes and each separate pipe is connected to a syringe. One-way valves are provided between some, or all of the pipes and their corresponding syringes.

According to an embodiment of the invention, the tube housing is replaceable, and it can be chosen to fit a desired tube. The device can be disposable. The device may further comprise a hydrophobic filter. The invention also relates to a method for isolating substances in a closed sterile system comprising: providing at least one syringe, fluid transport elements, which are connected to one-way valves, and if the system contains more than one syringe, a flow-splitting element, and a tube housing, comprising a needle; connecting a tube containing layered materials such that said tube is housed in the tube housing and the needle is inserted in the tube and in contact with at least one layer of material; creating in one of the syringes a lower pressure than the pressure that exists in the tube; and whenever desired, drawing material from the tube into the syringe.

Brief Description of the Drawings

In the drawings:

Fig. 1 is a front view of the device, according to one embodiment of the invention;

Fig. 2 A is a side view of the device of Fig. 1, with its bottom exposed;

Fig. 2B is an enlarged view of the bottom section of the device of Fig. 2A;

Fig. 2C is a cross-sectional view taken along the A-A axis of Fig. 2A;

Fig. 3 is a perspective view of the device of Fig. 1.

Fig. 4 is a cross-sectional view taken along the A-A axis of Fig. 2A, where a test tube is located under the device; and Fig. 5 is a cross-sectional view taken along the A-A axis of Fig. 2A, where a test tube is positioned inside the lower part of the device. Detailed Description of the Invention

The invention relates to a device that can be coupled to a tube, for example, a medical test tube, or to any other vessel comprising material, and can draw different materials from the tube, under sterile conditions. The device comprises: a cover, at least one syringe, fluid transport elements, and a tube housing, which will be described hereinafter.

According to an exemplary embodiment of the invention, the device comprises two syringes, and different materials are drawn from the same test tube into the syringes, each material into another syringe.

In the context of this description the term "fluid" should be interpreted in its broadest sense to include any material that can be drawn by suction, regardless of its solid content.

As shown in Fig 1, with reference to one embodiment of the invention, the device comprises two syringes 101 and 102. Tube housing 103 is connected to the cover 104 of the device. The connection between tube housing 103 and cover 104 can be any kind of connection. For additional isolation, the connection between tube housing 103 and cover 104 can prevent air (or any other external substance) from coming in contact with a fluid located inside the device, and it can be a non-permanent connection, so that tube housing 103 can be replaced with other tube housings of different sizes and shapes.

Fig. 2 A is a side view of the device of Fig. 1, in which a part of tube housing 103 is removed, revealing needle 201. Tube housing 103 is suitable to house a tube, while needle 201 is inserted into the tube. The tube housing will be chosen to fit a given tube, and/or the device will be chosen according to the size of its tube housing. The shape of cover 104, as shown in Figs 2A and 2B, is an example of a cover suitable for comfortable grasp, but is not meant to limit the invention to a certain shape of cover. The cover does not have any special functional features, and therefore can be of any suitable shape.

An enlarged view of the exposed section of Fig. 2 A, showing needle 201, is shown in Fig. 2B. Needle 201 is used for drawing materials from the tube that is inserted in tube housing 103. In many applications, test tubes are sealed and have a top cover, e.g., a rubber cap, or a septum, suitable for the insertion of vacuuming needles, such as needle 201. Needle 201 is basically a thin tube, through which fluids can be transported from a test tube, and may have a sharp end for piercing the top cover of the tube.

One object of tube housing 103 is to provide protection from needle 201, and essentially prevent a possible contact with needle 201, which can cause injury, and also de-sterilize the needle if it is accidentally touched.

Fig. 2C is a cross-sectional view taken along the A-A axis of Fig. 2A, showing also the inside components of the device, which are the fluid transport elements generally indicated at 200. Needle 201 is also a fluid transport element, through which materials (i.e., fluids) flow into the device from a tube. Needle 201 is connected at its other end to a flow system 202, by a flow- splitting element, which in this case is a V-junction 203 (which may have different shapes, according to the number of syringes or the physical configuration of the device). The structural shape of flow system 202 and V-junction 203 is determined be the number of syringes. In this embodiment there are two syringes 101 and 102, and hence flow system 202 is divided in two separate pipes, and V-junction 203 is provided, which comprises two outlets. A junction, such as V-junction in Fig. 2C, or any other shape of junction, can be provided for splitting materials from a test tube into different syringes. However, in a case of a single syringe, a junction is not required.

Before entering syringes 101 and 102, the fluid goes through one-way- valves 204 and 205, respectively. The suction is performed by creating a lower pressure in syringes 101 and/or 102 than in the tube, causing a suction of the materials from needle 201 that is in contact with the materials. The location of valves 204 and 205 can be any point along flow system 202. Alternatively, they can be connected directly to test tube 401 or syringes 101 and/or 102.

Once the extracted materials enter syringes 101 and/or 102, valves 204 and/or 205 prevent the materials from flowing back in the opposite direction. A reverse flow (even in a small amount in the form of a minor leak) can cause contamination of the device and/or the materials. If the reverse flow reaches the material-comprising vessel, it can also cause a mixing of the layers of the materials. The reverse flow can also occur due to operational errors, such as injecting the material from the syringe back into the system by mistake. Either way - this phenomenon can cause contamination of the system and also prevent it from achieving reproducible results.

Valves 204 and 205 prevent materials from flowing from syringes 101 and 102, back into flow system 202. Without valves 204 and 205, in case of a reversed flow, a second suction will be contaminating and the device will no longer be sterile and can no longer be considered as a closed system.

After drawing materials into syringes 101 and/or 102, the pressure inside syringes 101 and/or 102 is balanced by a natural volume adjustment, which is achieved by valves 204 and 205, until the pressure inside syringes 101 and/or 102 evens with the pressure of the environment. When there is no pressure gradient between a syringe and the environment, the materials will not flow outside of the syringe, even when detaching the syringe from the device. The care giver is protected from coming in contact with the materials that stay isolated inside the syringe.

Until the pressure in the syringes evens (with the environment), there is also a danger of air entering the syringes when they are being detached from the device. The use of one-way-valves prevents any further flow, and allows the pressure inside the syringe to reach an atmospheric pressure without air penetration from the environment, before the syringe is detached from the device. Therefore, one-way-valves are crucial for the closed suction system, proposed by the present invention.

The tube or container stays under low pressure throughout the entire process, even when the syringes are detached. In this way, there is no penetration of outside air from the environment, in order to equalize pressures. This air penetration phenomenon is successfully avoided due to the combination of one way valves and the sealing effect between the penetrating needle and the rubber cup of the tube, which creates a closed system, which in one hand, stays always in low pressure, and on the other hand, keeps normal atmospheric pressure within the syringes, once suction has ended.

The device of the invention is very efficient when trying to isolate different materials from the same tube. The materials can be layered inside the tube (by a centrifuge process, for example), and then drawn into separate syringes, without exposing the materials to the environment at any point, and while maintaining sterile conditions, and under vacuum conditions throughout the whole process Of course, one or more materials can be drawn from a single tube, in which separate layers of materials are present, into one or more syringes.

Detachment of a syringe does not affect the other components of the device and does not cancel the suction conditions throughout the remaining process in other parts of the device, and does not limit the use of the other syringes of the device. Every syringe is connected to a one-way valve, such that the detachment of a syringe has no impact on the operation of the device, and no impact on the pressure within the tube or the flow line, even when other syringes are connected to the device.

As said, one example of a process that can benefit from the invention is the production of PRP. With reference again to the figures, in this process, a blood test tube that comprises divided layers of different blood components is located inside tube housing 103 and connected to the device. Needle 201 is in contact with the mixture inside the tube, and the length of the part of needle 201 that is inserted to the tube, can be in an appropriate length for suction of a certain layer of the mixture, or it can be inserted all the way to the bottom of the tube so it will always perform suction at the bottom layer. When creating a lower pressure in one of syringes 101 or 102, as compared with the pressure in the tube, the material that is in contact with needle 201 is drawn into the syringe.

After one material is drawn into one syringe, the second material can be sucked into the same syringe or into another. In PRP mixtures, usually the blood platelets and the plasma are drawn into the same syringe, to yield the desired concentration of platelets. Other unnecessary substances, such as spare plasma, or red and white blood cells, can be left inside the tube, or can also be sucked into a different syringe. PRP mixtures can also be used for treating sport injuries, and are not only used for cosmetic applications, since the platelets induce a fast healing process (due to a known process in the human body, in which PRP causes a release of proteins that contribute to tissue growth and regeneration). For any purpose, a care giver will usually be the one who determines the desired concentration of platelets in a PRP mixture.

When used with a gel separation tube, the device can also be used for a safe and controlled re-suspension of platelets from the gel surface. In this application, after one syringe is used for extracting PPP (Platelet Poor Plasma), and before drawing the remaining plasma to the second syringe, the device is shaken repeatedly in order to release the platelets from the gel surface back to re-suspension in the remaining PPP, thereby creating a concentrated PRP serum which is then drawn to the final syringe, ready to be used. The use of separation gel is known in the existing art, and many test tubes are provided with a separation gel. The gel also helps to the separation of layers in a centrifuge process.

The significant advantage of the device of the invention and its method of use is the fact that the materials that flow from a tube into a syringe do not, at any point, come in contact with the environment, thereby providing a sterile process, all while preventing the materials from leaking, and also while preventing air from entering the vacuuming devices (e.g., syringes and tube). Nevertheless, the final mixture can be injected directly to a patient, in the same syringe that contains the mixture. Obviously, the device of the invention can be disposable (which is preferable when practicing medical procedures).

Fig. 3 is a perspective view of the device of Fig. 1, showing the shape of cover 104. This view also shows how needle 201 is located inside tube housing 103, which is cut out in this figure as in Fig. 2A. Fig. 4 is a cross-sectional view taken along the A-A axis of Fig. 2A, showing a test tube 401, which is located under tube housing 103. Test tube 401 comprises a rubber cap 402 that is provided for sealing materials inside test tube 401. Needle 201 is built to pierce rubber cap 402, without exposing the materials inside test tube 401 to the environment. Tube housing 103 also centralizes test tube 401 under needle 201, and protects the care giver from becoming in contact with needle 201.

In closed systems, the pressure inside test tubes is somotimo essentially lower than the pressure of the surrounding environment, in order to contribute to the suction process of the materials from the tubes. Rubber cap 402 is suitable to prevent natural pressure regulating, even when needle 201 pierces through it.

Fig. 5 is a cross-sectional view taken along the A-A axis of Fig. 2A, showing test tube 401 positioned inside tube housing 103, wherein needle 201 was inserted through rubber cap 402 and into test tube 401. This figure shows another advantage of the invention, which is the fact that the structural design of this device forces needle 201 to be inserted into test tube 401 through the middle of rubber cap 402. Positioning a needle in the middle of a test tube contributes to the quality of the drawn materials, as they are less affected by the conditions on the walls of the test tube (such as temperature, dry residue, and separation materials like gel).

According to another exemplary embodiment of the invention, a syringe can be replaced with another syringe, such that both syringes will be filled with materials from the same test tube. The replacement of the syringed does not hurt the sterility of the system, and therefore can be performed for unlimited number of times. According to another embodiment of the invention, the device further comprises a hydrophobic filter, which is a known component according to the existing art that allows a flow regulation of materials, and can replace the vacuum.

All the above description has been provided for the purpose of illustration and is not meant to limit the invention in any way. The invention presents significant advantages over the existing art. For example, the sterile and suction conditions under which substances can be transported from a tube, all the way into a human body.