Patent Application
20140319081
The present disclosure relates to systems, methods, and kits for production of autologous serum blood products such as autologous serum eye drops.
Many individuals suffer from severe dryness of the eye, resulting in redness, itching and pain. Many synthetic eye drops are commercially available, and treatment with these drops helps some patients. However, synthetic drops are not effective for many patients. A recently-developed alternative to synthetic eye drops is autologous serum eye drops made from a patient's own blood. These natural drops contain ingredients known to speed healing and increase lubrication of the surface of the eye.
Because the raw material for autologous serum eye drops is the patient's own blood, producing these drops is a complex process involving collection, processing, and dilution of blood serum. Moreover, the process has to comply with certain regulatory requirements. Although some of the components exist for blood collection, to date there is no complete commercial system for making autologous eye drops efficiently and in large scale quantities. Existing systems for collecting blood for autologous blood products involve glass vials, caps, and connections between individual vials to be used during the filling process. However, such systems are inefficient and do not allow for variable dilutions as may be prescribed.
Therefore, there exists a need for a method, system and kit for producing autologous serum eye drops. More particularly, there is a need for a system of producing autologous serum eye drops that includes all supplies and materials for collecting, processing, diluting and dispensing diluted serum product. There is also a need for methods of producing autologous serum eye drops that allow for variable dilutions. Finally, there is a need for a method, system and kit that facilitates efficient and scalable production of autologous serum eye drops.
The present disclosure, in its many embodiments, alleviates to a great extent the disadvantages of known blood collection and blood serum production systems by providing methods, systems and kits for production of autologous blood products in which several distinct subsystems having unique features for collecting blood, diluting and filtering serum and aliquotting the diluted serum are provided. The present disclosure provides significant advantages such as facilitating efficient and scalable production of autologous serum eye drops.
Exemplary embodiments include a system of making autologous blood products, comprising a blood collection assembly, a dilution assembly fluidly connected to the blood collection assembly, and an aliquot assembly fluidly connected to the dilution assembly. The blood collection assembly includes a collection container and a serum container. The dilution assembly includes a serum measurement device, a serum dilution bag, and a mixing system enabling serum to be mixed with balanced saline solution in a defined dilution ratio. The aliquot assembly includes at least one filter and aliquot tubing having periodic segment length markings.
In exemplary embodiments, the system further comprises a sealing device to seal each segment of aliquot tubing. The blood collection assembly may further include a needle and a needle guard. The serum container may be a 150 mL bag, and the collection container may be a 150 mL bag. The mixing device may be a syringe. In exemplary embodiments, the at least one filter comprises a materials filter and a sterilization filter, and the materials filter is a 40 micron pre-filter and the sterilization filter is a 0.2 micron filter.
In exemplary embodiments, the mixing system comprises a branched dilution tube including a balanced saline solution input line, a serum container input line, a first clamp to control flow of serum, a second clamp to control flow of balanced saline solution, and a third clamp to control flow of serum-saline solution into the serum dilution bag. Each segment length marking of the aliquot tubing may contain a unique identifier. The aliquot tubing may also define at least one air vent allowing air in the tubing to exit as the tubing is filled with serum-saline solution.
Exemplary embodiments include methods of making autologous blood products. Exemplary methods may comprise the steps of collecting blood from a patient and allowing the blood to clot, separating blood serum and collecting the serum in a container, mixing the serum with balanced saline solution in a defined dilution ratio, filtering the serum-saline solution, directing the serum-saline solution into aliquot tubing, and producing a plurality of aliquots of serum-saline solution by sealing the aliquot tubing at periodic length segments. Such methods may further comprise freezing each aliquot of serum-saline solution. In exemplary embodiments, the filtering step comprises filtering of materials and sterilization filtering. Exemplary methods may further comprise using beads to clot the collected blood. Such methods may also comprise marking each periodic length segment with a unique identifier.
Exemplary embodiments include autologous blood products production kits. Such a kit comprises a blood collection set, a serum dilution set fluidly connected to the blood collection set, and an aliquot set fluidly connected to the serum dilution set. The blood collection set includes a collection container and a serum container. The serum dilution set includes a serum measurement device, a serum dilution bag, and a mixing device enabling serum to be mixed with balanced saline solution in a defined dilution ratio. The aliquot set includes a materials filter, a sterilization filter, and aliquot tubing having periodic segment length markings.
In exemplary embodiments, the kit's mixing system comprises a branched dilution tube including a balanced saline solution input line, a serum container input line, a first clamp to control flow of serum, a second clamp to control flow of balanced saline solution, and a third clamp to control flow of serum-saline solution into the serum dilution bag. Such kits may further comprise a sealing device to seal each segment of aliquot tubing. The blood collection assembly may also include a needle and a needle guard. Each segment length marking of the aliquot tubing may contain a unique identifier.
Accordingly, it is seen that methods, systems and kits are provided which allow efficient and scalable production of autologous serum blood products such as autologous serum eye drops. These and other features of the present invention will be appreciated from review of the following detailed description of the invention, along with the accompanying figures in which like reference numbers refer to like parts throughout.
The foregoing and other objects of the disclosure will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which:
In the following paragraphs, embodiments will be described in detail by way of example with reference to the accompanying drawings, which are not drawn to scale, and the illustrated components are not necessarily drawn proportionately to one another. Throughout this description, the embodiments and examples shown should be considered as exemplars, rather than as limitations of the present disclosure. As used herein, the “present disclosure” refers to any one of the embodiments described herein, and any equivalents. Furthermore, reference to various aspects of the disclosure throughout this document does not mean that all claimed embodiments or methods must include the referenced aspects. Reference to temperature, pressure, density and other parameters should be considered as representative and illustrative of the capabilities of exemplary embodiments, and embodiments can operate with a wide variety of such parameters. It should be noted that the figures do not show every piece of equipment, nor the pressures, temperatures and flow rates of the various streams.
Exemplary embodiments of a system and method of producing autologous blood products will be described in general terms with reference to
Turning to
The blood collection assembly 110 also includes a serum container 114 for collecting the serum from the collected blood. More particularly, the serum container 114 is used to express off the serum from the clotted red blood cells. In exemplary embodiments, the serum container 114 is a satellite bag having a volume capacity of up to about 450 mL, and in some instances, the bag volume is 150 mL. A network of tubing and valves connects the collection container 112 to the serum container 114, and also extends to a needle 116 and needle guard 118 for drawing blood from a patient. A vacutainer adapter 120 may also be included in the blood collection assembly 110 for collecting sample tubes of a patients blood.
A sterile serum input line of tubing 122 extends from the serum container 114 and provides a fluid connection between the blood collection assembly 110 and the dilution assembly 124, which allows the collected serum to be mixed with balanced saline solution in a defined ratio. With reference to
The dilution assembly 124 also includes a mixing system 130 to enable the serum to mixed with balanced saline solution in a defined and adjustable ratio. An exemplary ratio would be about 20% dilution, but other dilutions in the range of about 10% to about 50% could be used. An exemplary embodiment of a mixing system 130 comprises a branched dilution tube network 132 fluidly connected to the serum input line 122. The branched dilution tube network 132 includes a serum dilution bag line 134 fluidly connected to the serum dilution bag 128, a serum measurement device line 136 fluidly connected to the serum measurement device 126, and a balanced saline solution line 138 having a spike 140 at its distal end for asceptic connection to a source of balanced saline solution.
Balanced saline solution flows from a balanced saline solution source (not shown) through balanced saline solution line 138, and serum flows from the serum container 114 of the blood collection assembly 110 through the serum input line 122. The serum measurement device 126 draws up measured amounts of serum and balanced saline solution through the serum measurement device line 136. A first clamp 142 controls the flow of serum through the serum input line 122. A second clamp 144 may be located on the balanced saline solution line 138 and may be used to control the flow of balanced saline solution. A third clamp 146 may be located on the serum dilution bag line 134 to control the flow of serum and saline solution dispensed from the serum measurement device 126 to the serum dilution bag 128. It should be noted that, with the exception of the saline spike, the dilution assembly 124 is a closed system.
Exemplary embodiments of an aliquot assembly and serum solution aliquots or segments will now be described with reference to
As best seen in
In operation, a patient who could benefit from autologous serum eye drops sees a doctor, nurse or other phlebotomist, who uses an exemplary autologous blood products collection kit 1, illustrated in
Next, a laboratory technician uses the mixing system 130 including the branched dilution tube network 132 to direct the serum from the serum bag 114 of the blood collection set 110 through the serum input line 122 of the serum dilution set 124. The technician then directs the desired ratio of serum mixed with balanced saline solution using the mixing system 130. More particular, the technician directs balanced saline solution from a saline source through balanced saline solution line 138 and the serum through the serum input line 122 and uses the serum measurement device 126, e.g., an integral syringe, to draw measured amounts of serum and balanced saline solution.
The technician can regulate the flow of serum through the serum input line 122 by using first clamp 142. Similarly, the technician can use the second clamp 144 to control the flow of balanced saline solution through balanced saline solution line 138. The technician can use the third clamp 146 to control the flow of the serum-saline solution into the serum dilution bag 128. Once the serum-saline solution is diluted to the desired ratio in the serum dilution bag 128, the technician can use the aliquot set 150 dispense aliquots of solution for distribution and use as autologous serum eye drops.
First, the technician directs the diluted serum-saline solution through the materials filter 152 at the proximal end of the aliquot tubing 156 to remove any remaining clotted material from the serum-saline solution. Next, the diluted serum-saline solution is directed through the sterilization filter 154 to sterilize the diluted serum-saline solution. The now sterile final serum-saline solution is then directed into the approximately 1,000-inch long aliquot tubing 156. The technician may utilize an air vent 158 to allow any air in the aliquot tubing 156 to exit the tubing as the final serum-saline solution flows in and fills up the tube.
Once the aliquot tubing 156 is filled with the final serum-saline solution, the technician seals the individual short segments 162 of tubing to create segmented aliquots of final serum-saline solution. The technician can then separate the individual segmented aliquots 162 and, if desired, arrange them in a bundle 164 for transport or storage. If long-term storage is necessary, the technician may flash freeze the aliquots 162 to maintain their freshness and sterility. The technician can then ship the aliquots to a doctor or directly to a patient for use as autologous eye drops. Finally, the doctor or patient clips a corner 166 of the aliquot 162 and administers the drops to the eye through opening 168.
Advantageously, the above-described systems and methods allow for the controlled and sterile production of final diluted serum solution for use as autologous serum eye drops. The systems and methods can be used in a cGMP regulated laboratory environment which lends itself well to mass production.
Thus, it is seen that systems, methods and kits for production of autologus serum eye drops are provided. It should be understood that any of the foregoing configurations and specialized components or chemical compounds may be interchangeably used with any of the systems of the preceding embodiments. Although illustrative embodiments of the present invention are described hereinabove, it will be evident to one skilled in the art that various changes and modifications may be made therein without departing from the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
