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  Device for separation of platelets from whole bloodUSPTO Application #: 20060127875Title: Device for separation of platelets from whole blood Abstract: A method is described for separating, retrieving and concentrating platelets from whole blood relying on aggregation of the platelets followed by filtration. This method eliminates the need of a centrifuge for separating said cells from blood. To obtain cellular concentrates of platelets, blood is mixed with compatible agents that will aggregate cells while retaining contained growth factors. The resulting aggregates can then be separated from blood by filtration. If desired, the filter-captured aggregates are subject to a brief washing cycle where they are washed clean of residual aggregating agent, plasma, and red cells. Aggregates can then be partly or wholly deaggregated and the cells retrieved. The result is a suspension of cells and small aggregates with therapeutic levels of concentrated blood cells with included growth factors that are available for delivery to a wound site. A device that accomplishes the aforementioned process is also described. (end of abstract)
Agent: Thorpe North & Western, LLP. - Sandy, UT, US Inventors: Sivaprasad Sukavaneshvar, S. Fazal Mohammad USPTO Applicaton #: 20060127875 - Class: 435002000 (USPTO) Related Patent Categories: Chemistry: Molecular Biology And Microbiology, Maintaining Blood Or Sperm In A Physiologically Active State Or Compositions Thereof Or Therefor Or Methods Of In Vitro Blood Cell Separation Or Treatment The Patent Description & Claims data below is from USPTO Patent Application 20060127875. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This application is a divisional of U.S. patent application Ser. No. 10/141,626, filed on May 6, 2002 which claims the benefit of U.S. Provisional Application No. 60,289,224 filed on May 7, 2001, both of which are incorporated herein by reference in their entireties. FIELD OF THE INVENTION [0002] The present invention relates to wound healants, as well as systems, methods, and devices for harvesting growth factors. More specifically, by separating platelets from whole blood, growth factor rich platelets can be harvested, concentrated, and delivered for wound healing in accordance with embodiments of the present invention. BACKGROUD OF THE INVENTION [0003] An attractive emerging clinical approach for augmenting wound healing is the rapidly expanding clinical and surgical use of recombinant or autologous growth factors for improved therapeutic outcomes. Examples of areas where such wound healing compositions are useful include intractable decubitus and pressure ulcers; orthopedic bone defect repair and bone ingrowth in fixation and implantation procedures; plastic and maxillofacial surgery; burn skin grafts; connective tissue repair; periodontal surgery, etc., as described by: Knighton D R, Surgery, Gynecology & Obstetrics 170: 56-60. 1990; and in Slater M, J Orthop Res 13: 655-663. 1995. The widespread clinical and surgical acceptance of growth factor-based wound healing therapies are currently limited to some degree by the high cost associated with both recombinant and autologous growth factor healants, and the additional inconvenience of processing autologous cells intraoperatively. Although only few controlled comparisons have been made between autologous growth factor cocktails and purified protein recombinant growth factors for wound healing effectiveness, a single recombinant growth factor may be less effective in many wound healing applications than a combination of natural growth factors (PDGF, VEGF, TGF, EGF, etc.) present in platelets as suggested by Cromack D T, J Trauma. 30: S129-S133, 1990. To that end, several potentially therapeutic growth factor compositions have been developed that contain more than one growth factor. However, the clinical applicability of some of these healants can be limited by high cost and inconvenience of obtaining growth factor compositions for use. [0004] The process described herein would allow for a cost effective, timely, and convenient technique for isolation and concentration of autologous or homologous platelets with included active growth factors. These cells may be harvested from small volumes of patient blood preoperatively, intraoperatively, perioperatively, or for outpatient procedures to allow for convenient and sustained delivery of growth factors to effectively promote healing. Current autologous growth factor harvesting systems are expensive and rely on technician-intensive blood processing to generate platelet rich plasma (PRP) prior to the additional steps required to harvest platelets to desired therapeutic concentrations, e.g., by centrifugation, by gel filtration, or by ultrafiltration. Laboratory separation by gravity has also been used, though time constraints makes this a less desirable approach. SUMMARY OF THE INVENTION [0005] It has been recognized that providing a wound healant using systems, methods, and devices to rapidly, conveniently and cost-effectively harvest platelets from whole blood using aggregation of platelets followed by filtration of those aggregates and appropriate retrieval would be an advancement in the area of accelerated wound healing. Such autologous platelet harvesting methods and systems can enable the elimination of the use of a centrifuge that can be expensive, inconvenient to operate, and can be more time consuming to use than the use of the systems, methods, and devices of the present invention. [0006] With this in mind, a method for separating platelets from whole blood can comprise the steps of (a) providing whole blood including platelets, leukocytes, erythrocytes, and blood plasma; (b) selectively aggregating platelets using an aggregating agent to form platelet aggregates that are larger in size than said leukocytes and erythrocytes; and (c) substantially separating the platelet aggregates from the leukocytes, erythrocytes, and blood plasma. Alternatively, a method for separating platelets from a platelet suspension can comprise the steps of (a) selectively aggregating platelets using an aggregating agent to form platelet aggregates in a platelet suspension where the aggregation function of platelets is realizable; and (b) separating the platelet aggregates from platelet suspension by filtration. The platelet suspension can be whole blood, platelet rich plasma, or a platelet pack, for example. [0007] In either of the above embodiments, the platelet aggregates obtained can then be washed, deaggregated, and/or suspended after separating, such as by filtration, in a desired solution. In one embodiment, the platelet aggregates can be deaggregated and concentrated to a desired therapeutic level for delivery to a wound site. Further, though centrifugation is not precluded by the present method, in a preferred embodiment, the platelets can be separated without the use of centrifugation. Additionally, the step of selectively aggregating the platelets can be enhanced by mixing the whole blood and the aggregating agent at a temperature from 20.degree. C. to 37.degree. C. for about 60 to 180 seconds. [0008] Many aggregating agents can be used in accordance with the present invention, including aggregating agents selected from the group consisting of thrombin, ristocetin, arachidonic acid, collagen, epinephrine, adenosine di-phosphate, and combinations thereof. A preferred aggregating agent for use is adenosine di-phosphate (ADP). [0009] In a more detailed aspect of the present invention, the platelets can be washed with a desired salt solution at a temperature from about 18.degree. C. to 30.degree. C. and for about 1 to 3 minutes to remove residual components including agonists, red blood cells, and plasma proteins. In another more detailed aspect, an additional step can be carried out that includes gently agitating/aspirating the aggregated platelets after separation with an appropriate solution to deaggregate and resuspend the platelets while minimizing degranulation, thereby recovering single cells and/or small cell aggregates. With this embodiment, the agitation/aspiration step can occur under controlled temperatures from 33.degree. C. to 37.degree. C., and at a pH from about 6 to 8. [0010] Once the platelets are collected, they can be applied to a wound, target tissue, or cells by any of a number of methods. For example, the step of filtering can be conducted with a biodegradable filter that can be placed directly on a wound site. Such a biodegradable filter can comprise a material selected from the group consisting of polyglycolic acid, polylactic acid, polypeptides, collagen, hyaluronic acid and combinations thereof Alternatively, suspended cells can be placed directly on a wound site, such as by a direct application, a poly-glycolic acid patch, a polyester patch, or a gel seal suture. Furthermore, platelets can be mixed with plasma, gelatin, fibrin/fibrinogen, alginates, chitosan or other sponges, bone fillers such as calcium phosphate, or other similar clinically accepted wound dressing/filling substrates. [0011] One additional aspect of the present invention that is desirable is the fact that autogolous treatment can occur within 15 minutes or less following blood collection. This is particularly useful for emergency reinfusion or transfusion of platelets. This is also useful in operating room settings where time is often critical during surgical procedures in which a wound healant is desired for use. [0012] In another embodiment, a device for separating platelets from whole blood can comprise a mixing/filtering chamber configured for mixing whole blood and an aggregating agent when positioned in a first orientation, and further configured for filtering platelet aggregates formed during mixing when positioned in a second orientation. The device can also contain an inlet or multiple inlets for transferring whole blood and the aggregating agent into the mixing/filtering chamber (together or separately), and washing the aggregates. The device can also comprise a mixing mechanism for mixing the whole blood and the aggregating agent when the mixing/filtering chamber is positioned in the first orientation, and a filter for collecting the platelet aggregates when the mixing/filtering chamber is positioned in the second orientation. One or more outlet ports can also be present for removing residual components of the whole blood that are not collected on the filter, and to provide a means to access, deaggregate and harvest the aggregates captured on the filter. In one embodiment, the mixing mechanism can be configured to optimize mixing, and to prevent substantial premature release of growth factor contents from the platelets, e.g., by means of a magnetic stirrer. [0013] In an alternative device embodiment, a device for separating platelets from whole blood can comprise a mixing chamber configured for receiving and mixing whole blood and an aggregating agent to form platelet aggregates and residual blood components. A filtering chamber can be configured for collecting platelet aggregated in the mixing chamber and allowing the residual blood components to substantially pass, wherein the filtering chamber comprises a porous filter. A valve can be placed between the mixing chamber and the filtering chamber for holding the whole blood and the aggregating agent in the mixing chamber during mixing, and for allowing flow of the platelet aggregates and the residual blood components from the mixing chamber in to the filtering chamber to separate aggregates from blood. Additionally, an outlet or filter port can be present and configured for removing components of the whole blood that are not collected in the filter. [0014] The filter used in either of the above device embodiments can be made of single or multiple stages of filters with a pore size ranging from 15 to 500 .mu.m, though a more preferred pore size can range from 15 to 100 .mu.m. In one embodiment, the filter can comprise a material selected from the group consisting of metals, polymers, biomaterials, biodegradable materials, and combinations thereof. In more detail, the filter can comprise a material selected from the group consisting of stainless steel, nylon, poly-tetra-fluoro-ethylene (Teflon), polyester, and/or hyaluronic acid. The outlet port can also act as an inlet port for injecting a physiological medium for washing and/or for injecting a deaggregating agent, though this is not required. In further detail with respect to preferred structures, the mixing device can comprise an electromagnetic motor and a magnetic stir bar. [0015] In still another embodiment, a wound healant for human tissue can comprise a physiological solution, essentially free of thrombin or other degranulating agents, autologous platelets suspended in the physiological solution; and a clinical carrier substrate configured for carrying the platelets to a wound site. Such a solution is merely one possible composition that can be prepared in accordance with the methods of the present invention. However, this composition can be desirable for use because wound treatment can be effected without the step of adding a degranulating agent, e.g., thrombin, that are typically used in the art. [0016] Alternatively, a wound healant for application to tissue can comprise a combination of platelet aggregates and single platelets, wherein the platelet aggregates and the single platelets are suspended in a physiological solution and carried by a clinical carrier substrate. An advantage of utilizing such a combination includes the possibility that aggregated platelets may provide immediate release of growth factor to a tissue, whereas individual, non-aggregated platelets may provide growth factor to a tissue site over time. Therefore, such a wound healant can provide immediate growth factor treatment to a tissue, as well as provide some sustained release of growth factor over time. [0017] In either of the above embodiments, substantially intact platelets can be delivered directly in, for example, a physiological solution such as isotonic saline solutions. In one embodiment of such a wound healant, the autologous platelets with contained growth factors can be present at a concentration greater than three times normal levels compared to that present in blood, wherein the platelet is not substantially activated by degranulating agents such as thrombin. Further, the physiological solution that acts as the wound healant can be essentially free of serum or plasma proteins. [0018] As described herein with respect to a process of the present invention, the platelets can be prepared and be present as single cells or small aggregates of cells that are distributed within a clinical carrier substrate, thereby providing a dispersed and prolonged release of growth factors. The healant can be delivered as suspended cells in a physiological solution, in a patch such as a poly-glycolic acid patch, a polyester patch such as a Darcon patch, or as a gel such as part of a gel suture system. Additionally, such a wound healant can also be combined with a hemostatic sealant to contribute growth-promoting properties of the wound healant. Further, such a wound healant can also be incorporated into aneurysm substrates or fillers such as coils or gels to accelerate the healing and/or re-integration of an aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS [0019] In the accompanying drawings which illustrate embodiments of the invention: [0020] FIG. 1 is a perspective view of a system in accordance with an embodiment of the present invention; Continue reading... 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