Abstract:
The present invention provides methods and devices for maintaining the integrity of blood products throughout preparation, processing and application to a patient or desired site. Coding methods are incorporated onto or into processing and delivery containers which coding methods contain information identifying the donor and/or recipient. Additionally or alternatively the coding methods may contain information pertaining to a specific preparation or application process to be carried out. Blood product processors and blood product applicators include decoding methods to ensure the blood product is administered to the appropriate recipient and further that it has been prepared and applied according to desired processes.

Description:
This application claims priority to Ser. No. 60/053,746 filed Jul. 25, 1997. 

   WO 97/20585 describes an applicator useful for delivering a biological polymer, such as a surgical sealant, to a desired site. The system for sealant application includes one or more cartridges which contain components to form the sealant and maintain them separately until co-application so as not to form the sealant prematurely and block the applicator. The components within the cartridges are fed through tubing means to the applicator nozzle by motion of pistons within the cartridges. The piston movement which enables delivery of the sealant components is, in turn, provided by a automated applicator drive unit which includes electromechanical drive means responsive to an actuator means activated by the surgeon or user. Preferably, the applicator is remote from the automated applicator drive unit such that the surgeon does not have to hold the sources of sealant components in her hand, providing for the design of a smaller, easier-to-use applicator. In preferred embodiments the sealant components can be a fibrin monomer solution and a polymer-initiating buffer as taught in EP 592242, or can be a fibrinogen component and a thrombin or thrombin-like enzyme component. Most preferably, the sealant components are from a single donor and optimally are autologous to the patient receiving the sealant. 
   U.S. Pat. No. 5,603,845 describes a preparation unit which is a closed container having at least two chambers separated by a piston moveable between the chambers. Blood can be placed onto the first chamber of such a preparation unit and placed in a centrifuge to separate plasma from red blood cells. Plasma is thereupon transferred to the second chamber and subjected to a process which concentrates a desired blood component, e.g., fibrin monomer. A fibrin monomer solution is thereafter collected in a removable cartridge within the preparation unit which collects the fibrin monomer as described in EP 654669 and can thereafter be removed and placed into the automated application unit of the application system described in WO 97/20585. Again, single donor preparations, preferably autologous to the patient, are preferred. Other preparation units are disclosed in U.S. Pat. Nos. 5,738,784, 5,733,446. 
   Technology such as that described above provides a method of preparing and applying a single donor, or preferably autologous, sealant to a patient. To maintain the integrity and ensure the reliability of this valuable technology, a system or method which safeguards against the misapplication of such biological polymers, e.g., fibrin sealants, would be a useful addition to the art. Further, the preparation unit as used in the above described U.S. Pat. Nos. 5,603,845, 5,738,784, 5,733,446 is placed within a programmable centrifuge unit which may include different programs to process the blood in different ways. For example, blood can be processed to provide differing concentrations of fibrin monomer, components other than fibrin monomer, a platelet-rich or platelet-poor component, or a smaller volume, e.g., for pediatric use. Preparation units which are different sizes, of different configuration or pre-loaded with different reagents may be employed. It is incumbent upon the centrifuge operator to select the proper centrifuge program according to the desired end product and consistent with the particular preparation unit employed. 
   SUMMARY OF THE INVENTION 
   In accordance with the present invention a system for applying a single donor or autologous blood product to a patient comprises:
         an applicator for applying the blood product;   an automated applicator drive unit in fluid communication with the applicator, which unit includes containers for components of the blood product, an electromechanical drive means to deliver the components to the applicator, wherein the drive means is responsive to a control means which is, in turn, responsive to an actuator means activated by the user;   coding means on the containers of components and on the patient which provides information identifying the desired donor and desired recipient of the components;   decoding means, connected to the control means, capable of blocking the application process if the information on the coding means of the patient does not correspond to the information in the coding means of the containers of the components.       

   In preferred embodiments the containers of components also serve as, or are a part of, the preparation unit used prior to the application process to prepare the components from the patient&#39;s blood. 
   Further, in accordance with the present invention, coding means are provided on a preparation unit or processing container for blood products so that a decoding means within the blood centrifuge or processor can read the code or the unit or container and automatically select the appropriate program or set of process steps for that particular unit or container. 

   
     BRIEF DESCRIPTION OF THE FIGURES 
       FIG. 1  illustrates an applicator system having coding and decoding means in accordance with the present invention. 
       FIG. 2  shows an alternate applicator system having coding and decoding means in accordance with the present invention. 
       FIG. 3  illustrates a cross-sectional view of a preparation unit or processing container, including a component cartridge, useful in the present invention. 
       FIG. 4  shows a preparation unit and component cartridge having coding means in accordance with the present invention. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The present method and devices provides an added level of reliability to blood processing systems which are utilized to prepare and deliver single donor or autologous blood products to patients. This is critical in any setting involving such procedures and becomes especially important in situations where multiple patients are being treated daily, even simultaneously, such as in a surgical suite of a hospital when the blood products are, for example, surgical sealants. The present method and device provide this extra reliability and accuracy by ensuring that
         1) the proper blood product is administered to the proper recipient or recipient site; and   2) the blood is processed in an accurate or desired manner, i.e., according to a desired process or set of process steps.       

     FIG. 1  shows a basic diagram of the present invention as applied to a surgical sealant application system, e.g., a system for applying a fibrin sealant to a patient. The system is shown to have an automated applicator drive unit which contains sources, i.e. containers, of at least one component for forming the desired sealant.  FIG. 1  illustrates two component containers and an optional gas source which can be utilized to facilitate spray delivery of the components. The automated applicator drive unit is in fluid communication with the applicator itself. It needs to be appreciated that any form of applicator can be utilized and that the applicator and drive unit, although preferably remote from each other, can be an integral unit. Dotted lines shows signal communication between the actuating means on the applicator and control means of the drive unit. The signal can be electrical or can be non-electrical as described in WO 97/20585 where the signal is differential air pressure, but can be any convenient means. In practice, the surgeon depresses the actuating means and the control means in response to the so-produced signal delivers components and/or gas from the containers, through the fluid/gas transfer means, to the applicator and out the nozzle for delivery to the desired site/ patient. Delivery of the components from the containers is accomplished by mechanical means to drive pistons into the component containers. 
   In accordance with the present invention such a system is further provided with coding means on one or both of the component containers and coding means on, or near, the patient. Coding means are indicated in  FIG. 1  by the oval shapes. The coding means each contain matching information corresponding to the desired donor and desired recipient or patient. Of course for autologous delivery the donor and recipient are the same person. Although the recipient throughout this application is referred to as a patient, it should be noted that this system could also be used to ensure the proper deposition at any desired site, i.e., to create a medical implant or medical device or form a film intended for a specific patient or for a dressing, suture or prosthetic device intended for a specific patient. Decoding means (designated in  FIG. 1  by the rectangles) are provided to read the information on one or both of the component containers and on the patient. These decoding means provide signals to the automated applicator drive unit and means are provided to make sealant application impossible if the information on the container(s) does not match the information on the patient. As shown in  FIG. 1 , the decoding means sends signals to the control means of the automated applicator drive unit, however these signals could be incorporated and processed elsewhere in the drive unit so as to provide the desired safeguard as would be apparent to those skilled in the art. 
     FIG. 2  provides another illustration of the an embodiment of the present invention wherein the application system is shown generally as  10 , comprising an applicator  12  and an automated drive unit  14 . The applicator  12  includes an actuating means  16  and a nozzle  18  and is in fluid communication with the drive unit,  14  via fluid transfer means  20 . The drive unit  14  is shown to include a control means  22  which can activate component drive means  24  and gas drive means  26  so as to deliver a sealant compound from a component container  28  and gas from a gas nozzle  30 . A signal from the actuator is communicated via actuator signal line  32  to control means  22  which is turn delivers “drive” or “off” signals to component drive means  24  and gas drive means  26  via control signal lines  34 ,  36 , respectively. The fluid transfer means  20  comprises a component delivery tube  38 , a gas delivery tube  40  and in this case an actuator tube  42  in communication with the actuator  16 , although other actuator signal producing means can be employed. Component container  28  and gas nozzle  30  are held in position by a retainer means  44 . Additional component containers can be added and connected, for example, to additional component delivery tube  46 . Tubing connection  48  couples with the gas nozzle  30  to the gas delivery tube  40  and another coupling (not shown) is used to couple the component container  28  (shown in cross section) to the component delivery tube  38 . 
   Further in FIG.  2  and in accordance with the present invention, a container decoding means  50  is shown as part of the drive unit  14  and capable of reading information on the container coding means  52 . Also, a patient decoding means  54  is provided to read the patient coding means  56 . Both decoding means are in signal communication with the control means  22  of the drive unit  14  so that application of the component to the patient will only occur if the information on each of the coding means  52 ,  56  match each other. 
   Also, in accordance with the present invention, the applicator drive unit may be capable of carrying out different application steps in applying the blood component, e.g., flow rotes, mixing ratios with other components, etc. The coding means on the component cartridge may additionally or alternatively include information corresponding to the specific application parameters to be employed. In this case, the decoding means within the applicator drive unit would be in signal communication with the control means to ensure that the desired application parameters are utilized. 
     FIG. 3  shows a preparation unit as disclosed in U.S. Pat. Nos. 5,603,845, 5,738,784, 5,733,446 generally as  60 . The details of this unit are described extensively in those published patent documents but basically the preparation unit has a first chamber  62  an a second chamber  64  separated by a piston  66 . Blood is placed in the first chamber  62  and centrifuged so as to separate plasma and cellular components. Plasma is thereafter transferred to the second chamber  64  and processed to concentrate a desired blood component which is ultimately collected in component container  28 . As can be seen by looking back at  FIG. 2 , component container  28  can thereafter be removed and placed into the automated applicator drive unit  14 . 
     FIG. 4  further shows removal of component container  28  shown within a protective sleeve  68  from the preparation unit  60 .  FIG. 4  also shows, further in accordance with the present invention, that not only container coding means  52  but also preparation unit coding means  70  can be incorporated into the present system. In many cases blood will be taken directly from the donor, placed into the preparation unit  60  and processed in a processor or centrifuge unit (not shown). If the container coding means  52  cannot readily be scanned when the component container  28  is down within the preparation unit  60  as shown in  FIG. 3  prior to processing, it may be useful to properly identify the correct blood-containing preparation unit  60  by way of the additional preparation unit coding means  70 . Further, this becomes especially important if the blood is taken from a donor far enough ahead of processing or use so as to require temporary storage and/or transfer of location. In this instance the possibility of interchanging blood-containing preparation units increases and the preparation unit coding means  70  becomes critical. This could be used in conjunction with a decoding means (not shown) either within the centrifuge processor (not shown) into which the preparation unit  60  is placed for processing or with a free standing decoding means. In either case, the purpose is to ensure that information on the preparation unit coding means  52  corresponds to information on the patient coding means  56  so that the correct blood is retrieved from storage and/or processed at the right time. It should be appreciated that the component container  28  can be actually serve as the preparation unit in situations where the blood is to be stored and/or processed in the component container  28  itself without the need for a preparation unit. 
   Also, as mentioned above, an important aspect of the present invention involves the incorporation of a decoding means into a centrifuge or other blood processing apparatus. This would provide that the centrifuge or process operator could properly ascertain the identity of the donor and/or recipient. In a further embodiment, the coding means on the preparation unit and/or component cartridge could include information regarding the specific process to be performed. A centrifuge or blood processor capable of running various programs or processes could decode the coded information and ensure that the proper program was employed. This is useful in preparing, e.g., differing concentrations of fibrin monomer, alternative blood components, platelet-rich or platelet-poor compositions or any other blood product for which the preparation process can be programmed into the centrifuge or processor. 
   The present invention can be utilized in any instance where a specific blood product is intended for delivery to a specific patient and can be employed for virtually any blood products. Fibrin sealant application is preferred and discussed herein but the present invention should not be so limited. Preferred fibrin sealant systems would concurrently deliver a fibrin monomer component and a polymer-initiating buffer solution, preferably with a gas to provide spray mixing all of which are disclosed in WO 97/20585. In this case the fibrin monomer solution container (at least) would include a coding means. In systems which apply autologous or single-donor fibrinogen and thrombin components, each of the containers for these components would include a coding means. In each case the coding means information on the component would be checked against coding means on the patient. 
   This system is readily employed when a kit including the preparation unit (with component container), venepuncture set (for taking blood) and applicator is provided. Such a kit would include identical coding means on the preparation unit, the component container and one on, or with, the venepuncture kit for the patient (preferably a bracelet or similar tag). Decoding means, as described above, are used to compare the patient code to the preparation unit code to ensure that the proper blood is processed and/or to ensure that the proper process in employed and/or to compare the resulting blood product to the patient to ensure that the proper blood product is applied to the intended patient. 
   Coding and decoding means as described herein can refer to any system or technology for labeling articles with a form of identification and providing certain action in response to reading such identification. Bar coding/scanning technology, laser etching, magnetic coding or any other technologies available could be employed. Bar coding and laser etching are ideally suited for this purpose and are the preferred methods of carrying out this invention.