Patent Application
20050278066
Most of the current nuclear medicine diagnostic procedures use a radioisotope. An illustrative, but nonlimiting, example of a radioisotope includes technetium (Tc-99m). The radioactive technetium, obtained from a generator located in a radio-pharmacy, is dissolved in a saline solution and is placed in an eluate vial which is surrounded by a lead eluate shield or pig. The activity level of this technetium is high (approximately 100 to 1,000 mCi/mL at time of preparation) and is often diluted before it is used. The radiopharmacy can prepare multi-dose vials of technetium and saline and/or ready-to-use kits that include: (a) technetium; (b) saline; and (c) lyophilized reagents. The multi-dose vials of technetium are also sold to hospitals and other medical facilities. The hospitals may use the technetium from the multi-dose vial to administer to a patient or to prepare their own lyophilized reagent kits. The multi-dose vials have an activity level that varies from 10-200 mCi/mL at time of preparation.
The ready-to-use kits include lyophilized reagents, which do not contain radioactive material, are the product of the “cold” production line. The lyophilized reagents have been formulated to collect at specific locations in the body such as the heart, bones or kidneys. The radioactive kits are prepared by mixing technetium and saline with the lyophilized reagents at the radiopharmacies. Most of these “prepared” kits contain several individual doses and have an activity level that varies widely depending on the type of radiopharmaceutical prescribed. The activity level in a “prepared kit” may range from 10 to 200 mCi/mL at the time of preparation.
Currently kits and multi-dose vials of radioisotopes, e.g., technetium, are filled by hand by a pharmacist and/or their technician at the radiopharmacy. This will lead to extremity exposure for the personnel during handling the radioactive materials (e.g., transferring liquid from one vial to another with the use of a syringe in a syringe shield). These pharmacists and technicians are required to wear extremity dosimeters and must comply with annual radiation exposure limits. If their cumulative radiation exposure limit nears their annual limit, the pharmacist or technician is restricted from the lab and must work elsewhere in the radiopharmacy. This will increase the manpower demands at the radiopharmacy and could potentially increase the level of radiation exposure for remaining pharmacists and technicians.
In one aspect of this invention, an automated bulk dispensing system is disclosed. This includes a first container, a second container, a third container, a first displacement mechanism that is operatively connected to the third container for displacing liquid from the third container, a recipient container, at least one first control valve, wherein the first container is connected in fluid relationship to the at least one first control valve and the second container is connected in fluid relationship to the at least one first control valve and the third container is connected in fluid relationship to the at least one first control valve, at least one first drive mechanism that is operatively attached, in one-to-one correspondence, to the at least one first control valve, wherein the at least one first drive mechanism by operation of the at least one first control valve can selectively control a flow of liquid from the first container into the third container, wherein the at least one first drive mechanism by operation of the at least one first control valve can selectively control a flow of liquid from the second container into the third container and wherein the at least one first drive mechanism by operation of the at least one first control valve can selectively control a flow of liquid from the third container into the recipient container, and a processor that is electrically connected to the at least one first drive mechanism and the first displacement mechanism for selective activation thereof.
In another aspect of this invention, a method for filling containers utilizing an automated bulk dispensing system is disclosed. This includes selectively receiving a predetermined amount of radioactive liquid from a second container into a third container through at least one first control valve, selectively receiving a predetermined amount of nonradioactive liquid from a first container into a third container that is operatively connected to the third container through at least one first control valve, mixing the radioactive liquid and the nonradioactive liquid in the third container with a first displacement mechanism, which is operatively connected to the third container for displacing liquid within the third container, wherein the first displacement mechanism is selectively controlled by a processor and is operatively connected thereto, and dispensing the mixture of the radioactive liquid and the nonradioactive liquid from the third container with the first displacement mechanism through the at least one first control valve and into a recipient container, wherein the first container is connected in fluid relationship to the at least one first control valve, the second container is connected in fluid relationship to the at least one first control valve and the third container is connected in fluid relationship to the at least one first control valve and there is at least one first drive mechanism that is operatively attached, in one-to-one correspondence, to the at least first control valve to selectively control the flow of liquid into and out of the third container, wherein the first drive mechanism is controlled by the processor and is operatively connected thereto.
In yet another aspect of this invention, an automated bulk dispensing system is disclosed. This includes a first container, a first control valve connected in fluid relationship to the first container, a second container, a second control valve connected in fluid relationship to the second container, a third container connected in fluid relationship to the second control valve, a first displacement mechanism that is operatively connected to the third container for dispensing fluid from the third container, a fourth container connected in fluid relationship to the first control valve, a second displacement mechanism that is operatively connected to the fourth container for dispensing fluid from the fourth container, a third control valve that is connected in fluid relationship between the first control valve and the second control valve, a first drive mechanism operatively attached to the first control valve for selectively controlling liquid flow from the first control valve, a second drive mechanism operatively attached to the second control valve for selectively controlling liquid flow from the second control valve, a third drive mechanism operatively attached to the third control valve for selectively controlling fluid flow from the first control valve, a recipient container that is connected in fluid relationship to the third control valve, and a processor that is operatively connected to the first displacement mechanism, the second displacement mechanism, the first drive mechanism, the second drive mechanism and the third drive mechanism.
In still another aspect of this invention, a method for filling containers utilizing an automated bulk dispensing system is disclosed. The method includes selectively receiving a predetermined amount of radioactive liquid from a second container into a third container through a second control valve, selectively receiving a predetermined amount of nonradioactive liquid from a first container into a fourth container through a first control valve, selectively transferring a predetermined amount of nonradioactive liquid from the fourth container into the third container through a third control valve and the second control valve with a first displacement mechanism, which is operatively connected to the fourth container for displacing liquid from the fourth container and the first displacement mechanism is selectively controlled by a processor and is operatively connected thereto, and mixing the radioactive liquid and the nonradioactive liquid in the third container with a second displacement mechanism, which is operatively connected to the third container for displacing liquid from the third container, wherein the second displacement mechanism is selectively controlled by a processor and is operatively connected thereto, and dispensing the mixture of the radioactive liquid and the nonradioactive liquid from the third container with the second displacement mechanism through the second control valve and the third control valve into a recipient container, wherein the first container and the fourth container are connected in fluid relationship to the first control valve, the second container and the third container are connected in fluid relationship to the second control valve, the first control valve and the second control valve are connected in fluid relationship to the third control valve and the recipient container is connected in fluid relationship to the third control valve, wherein there is a first drive mechanism that is operatively attached to the first control valve, a second drive mechanism that is operatively attached to the second control valve and a third second drive mechanism that is operatively attached to the third control valve, wherein the first drive mechanism, the second drive mechanism, and the third drive mechanism are all selectively controlled by the processor and are operatively connected thereto.
In yet another aspect of the present invention, a method for filling containers utilizing an automated bulk dispensing system is disclosed. This method includes selectively receiving a predetermined amount of radioactive liquid from a second container into a third container through a second control valve, selectively receiving a predetermined amount of nonradioactive liquid from a first container into a third container that is operatively connected to the third container through a first control valve, a third control valve and the second control valve, mixing the radioactive liquid and the nonradioactive liquid in the third container with a first displacement mechanism, which is operatively connected to the third container for displacing liquid within the third container, wherein the first displacement mechanism is selectively controlled by a processor and is operatively connected thereto, and dispensing the mixture of the radioactive liquid and the nonradioactive liquid from the third container with the first displacement mechanism through the second control valve and the third control valve and into a recipient container, wherein the first container is connected in fluid relationship to the first control valve, the second container is connected in fluid relationship to the second valve and the third container is connected in fluid relationship to the third control valve, the first control valve and the second control valve are connected in fluid relationship to the third control valve, wherein there is a first drive mechanism that is operatively attached to the first control valve, a second drive mechanism that is operatively attached to the second control valve and a third drive mechanism that is operatively attached to the third control valve, wherein the first drive mechanism, the second drive mechanism, and the third drive mechanism are all selectively controlled by the processor and are operatively connected thereto.
These are merely some of the innumerable aspects of the present invention and should not be deemed an all-inclusive listing of the innumerable aspects associated with the present invention. These and other aspects will become apparent to those skilled in the art in light of the following disclosure and accompanying drawings.
For a better understanding of the present invention, reference may be made to the accompanying drawings in which:
In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as to obscure the present invention.
Referring now to the drawings, and initially to
Also, in
Referring now to
Referring now to
As shown in
Referring now to
As shown in
A nonlimiting, but illustrative, example of a first motor 33 and a second motor 32 include HT17-075-2001 manufactured by Applied Motion Products, Inc. having a place of business at 404 Westridge Drive, Watsonville, Calif. 95076.
Referring now to
There is a first fluid conduit 71 that is connected between the first container 48 and a first fluid inlet 73 for a manifold 69 that connects a first control valve 52, a second control valve 54 and a third control valve 56, which are all selectively in fluid relationship. The manifold 69 operates as a fluid conduit that allows fluid to pass between the control valves 52, 54, and 56, when one or more of the control valves 52, 54, and 56 are open. The fluid inlet 73 and the fourth container 44 are both connected to the first control valve 52. The first control valve 52 is also connected via the manifold 69 to the third control valve 56.
Also, as shown in
Referring again to
The gas vent 64 is connected to fluid relationship to a bubble detector 62. The bubble detector 62 is connected in fluid relationship to the second control valve 54. The bubble detector 62 functions to determine if all bubbles in the fluid for the second container 50 have been dissipated via the gas vent 64. A wide variety of bubble detectors will suffice for this application. Illustrative, but nonlimiting, example of a bubble detector 62 includes those manufactured by Introtek International, having a place of business at 150 Executive Drive, Edgewood, N.Y. 11717-9998.
There is an outlet 100 to the manifold 69 that is connected in fluid relationship to the third control valve 56. There is a fluid delivery and gas venting mechanism that is generally indicated by numeral 60 in
There is a recipient container receiving liquid that is generally indicated by numeral 58 that is similar to the second container 50 for holding fluid. Preferably, but not necessarily, the recipient container 58 is held in place by a second c-shaped holder 140 and the presence of the recipient container 58 is sensed by a second proximity sensor 155, as shown in
As shown in
There is a first actuating mechanism 37, as shown in
The first actuating mechanism 37 includes a lead screw connected to a sixth motor 32, which is preferably a stepper motor, however, any motor that controls and monitors the position of the rotor and can move the rotor of the motor in controlled increments will suffice such as a servo-controlled motor or actuator controlled motor. The sixth motor 32 is attached to the first actuating mechanism 37. Optimally, there are limits, encoders and other mechanisms, to govern the limit of travel for the first actuating mechanism 37 and provide a fixed rotational starting point for the sixth motor 32. A nonlimiting, but illustrative, example of a sixth controlled motor 32 includes HT17-075-2001 manufactured by Applied Motion Products, Inc. having a place of business at 404 Westridge Drive, Watsonville, Calif. 95076. As shown in
By utilizing the manifold 69, as shown in
An illustrative, but nonlimiting, example of the manifold 69, including the first control valve 52, second control valve 54 and third control valve 56 each includes a DISCOFIX® three (3) way triple stopcock assembly such at that manufactured by B. Braun Melsungen Aktiengesellschaft having a place of business at Carl-Braun-Strasse, 1 Melsungen, Federal Republic of Germany. However, a wide variety of valves will suffice for a control valve 52, 54 and 56, including, but not limited to, needle valves, diaphragm valves, plug valves, glove valves, butterfly valves, and check valves.
Referring now to
The first drive mechanism 78, the second drive mechanism 76 and the third drive mechanism 80 are each attached to a first motor 77, a second motor 75 and a third motor 79, respectively. The first motor 77, the second motor 75 and the third motor 79 are each preferably a stepper motor that rotates in fixed increments, however, any motor that controls and monitors the position of the rotor will suffice such as a servo-controlled motor or actuator controlled motor. Also, pneumatic and vacuum systems can be utilized as drive mechanisms.
Illustrative, but nonlimiting, examples of stepper-controlled motors that can be utilized for the first motor 77, the second motor 75, and the third motor 79 include HT17-075 manufactured by Applied Motion Products, Inc., having a place of business at 404 Westridge Drive, Watsonville, Calif. 95076. Optimally, there are limits, encoders and other mechanisms, to provide a fixed rotational starting point for the first motor 77, the second motor 75, and the third motor 79.
The method of using the previously described automated dispensing system 10 is now described. This automated dispensing system 10 is particularly advantageous for most of the current nuclear medicine diagnostic procedures that use the radioisotope technetium (Tc-99m). The radioactive technetium, obtained from a generator located in a radio-pharmacy, is dissolved in a nonradioactive liquid, e.g., saline solution, and is placed in a vial 104 that is surrounded by a lead shield or pig 108. The activity level of this technetium is high (approximately 100 to 1,000 mCi/mL) and must is typically diluted before it is used.
The purpose of the automated bulk dispensing system is to prepare either (1) ready-to-use kits that include (a) radioactive liquid, e.g., technetium, (b) nonradioactive liquid, e.g., saline solution, and (c) lyophilized reagents or (2) multi-dose vials of radioactive liquid, e.g., technetium, and nonradioactive liquid, e.g., saline solution. The multi-dose vials of radioactive liquid, e.g., technetium, are also sold to hospitals and other medical facilities. The hospital or medical facility uses the technetium from the multi-dose vial to prepare their own kits. The multi-dose vials 104 have an activity level that varies from 10-200 mCi/mL. The ready-to-use kits include lyophilized reagents, which do not contain radioactive material, are the product of a “cold” production line. The lyophilized reagents 136, as shown in
The following description is the operational sequence for preparing and filling a kit. All of the functions of the automated bulk dispensing system 10 are controlled by the processor 16. The operator is able to input data from the electronic display 14 that has a touch screen capability or from the keyboard 12 and/or mouse 13, as shown in
Referring now to
Referring again to
The goal is to transfer radioactive liquid, e.g., technetium, from the eluate vial 104 and nonradioactive liquid, e.g., saline solution, from the first container 48 into the recipient container 58 to prepare the kit. The shelf life of an empty kit with lyophilized reagents 136 is relatively long. However, once the radioactive liquid, e.g., technetium, and nonradioactive liquid, e.g., saline solution, are added to the kit, the shelf life of the kit is considerably diminished. Therefore, kits are typically only prepared on an as-needed basis. The radioactivity of the fluid in the recipient container 58 and the second container is calculated by the processor 16 and is a timing function.
After all of the independent variables have been entered into the processor 16, the automated bulk dispensing system 10 is actuated and the filling process proceeds automatically. The manifold 69, the third container 46, e.g., 35 mL syringe, and the fourth container 44, e.g., 10 mL syringe, are blocked from the operator's view behind the cover enclosure 5.
The following description provides the operational sequence involved with the filling of a kit. The first step is that the third control valve 56 is closed by operation of the third drive mechanism 80 and the second control valve 54 is opened by operation of the second drive mechanism 76. The first displacement mechanism, e.g., actuator, 35 is activated to draw the radioactive liquid, e.g., technetium, from the eluate vial 104 for the second container 50 into the third container 46, e.g., 35 mL syringe. The radioactive liquid, e.g., technetium, from several eluate vials 104 may be transferred to the third container 46, e.g., 35 mL syringe. This depends on the type and number of kits that are being prepared.
The second step is that the first control valve 52 and the third control valve 56 are then opened and the nonradioactive liquid, e.g., saline solution, flows from the first container 48 and is pulled into the third container 46, e.g., 35 mL syringe. Then the third container 46, e.g., 35 mL syringe, is activated and the first plunger 94 draws the required amount of liquid, e.g., saline solution, into the third container 46, e.g., 35 mL syringe.
The third step is that the third control valve 56 is then closed via the third drive mechanism 80. The third container 46, e.g., 35 mL syringe, is then stroked several times via the first displacement mechanism, e.g., actuator, 35 to mix the radioactive liquid, e.g., technetium, with the nonradioactive liquid, e.g., saline solution. The gas vent 64 allows gas to move in and out of the third container 46, e.g., 35 mL syringe, while the first plunger 94 is being stroked by the first mechanism, e.g., actuator, 35.
In the fourth step, the third control valve 56 is then opened and the third container 46, e.g., 35 mL syringe, is discharged allowing the mixture of radioactive liquid, e.g., technetium, and nonradioactive liquid, e.g., saline solution, to flow through the manifold outlet 100 through the fluid delivery and gas venting device 60, e.g., micro-mini spike, and into the recipient container 58.
Depending on the preparation parameters for a multi-dose container, e.g., desired final concentration of dispense radioactive solution, the first control valve 52 may be opened so that additional nonradioactive liquid, e.g., saline solution, from the first container 48 may be added to the final recipient container 58. If required, the first control valve 52 is opened by operation of the first drive mechanism 78 so that the nonradioactive fluid, e.g., saline solution, flows from the first container 48 to the third container 46, e.g., 35 ml syringe. If no additional saline solution is ever needed, the first control valve 52 is not opened and the third drive mechanism 80 is not activated.
After the recipient container 58, e.g., vial, is filled to a predetermined level, the fluid delivery and gas venting mechanism 60, e.g., micro-mini spike, is removed from the recipient container 58 by the first actuating mechanism 162 and replaced with a new recipient container 58. Several of the recipient containers 58, e.g., vials, containing lyophilized reagents 136 may be sequentially filled depending on the situation.
Completed kits are assayed for activity in a source calibrator (not shown) and are labeled for shipment to the hospital or used by the radio-pharmacy for dispensing the radiopharmaceutical into unit dosages, i.e., syringes. The completed kits are kept in lead containers or pigs 108 so that the completed kits can be safely handled. The fluid delivery and gas venting mechanism 60, e.g., micro-mini spike, is preferably changed after each drug type, e.g., vial, containing the lyophilized reagent 136 or may be flushed with saline solution from first container 48 after the preparation of a similar drug type kits are completed to prevent cross-contamination.
The following description provides the operational sequence involved with the filling of a multi-dose container of radioactive liquid, e.g., technetium. Again, after all of the independent variables have been entered into the processor 16, the automated bulk dispensing system 10 is actuated and the filling process proceeds automatically.
The first step is that the third control valve 56 is closed by operation of the third drive mechanism 80 and the second control valve 54 is opened by operation of the second drive mechanism 76. The first displacement mechanism, e.g., actuator, 35 is actuated to draw the radioactive liquid, e.g., technetium, from the eluate vial 104 of the second container 50 into the third container 46, e.g., 35 mL syringe. The radioactive liquid, e.g., technetium, from several eluate vials 104 may be transferred to a third container 46, e.g., 35 mL syringe.
The second step is that the first control valve 52 is opened by operation of the first drive mechanism 78 and the third control valve 56 is opened by operation of the third drive mechanism 80 so that the nonradioactive liquid, e.g., saline solution, flows or is pulled from the first container 48 to the third container 46, e.g., 35 mL syringe.
The third step is that the third control valve 56 is then closed via the third drive mechanism 80. The fourth step is that the third container 46, e.g., 35 mL syringe, is then stroked several times via the first mechanism, e.g., actuator, 35 to mix the radioactive liquid, e.g., technetium, with the nonradioactive liquid, e.g., saline solution. The gas vent 64 allows gas to move in and out of the third container 46, e.g., 35 mL syringe, while the first plunger 94 is being stroked by the first mechanism, e.g., actuator, 35.
The fourth step is that is that the third control valve 56 is then opened and the third container 46, e.g., 35 mL syringe, is discharged allowing the mixture of radioactive liquid, e.g., technetium, and nonradioactive liquid, e.g., saline solution, to flow through the outlet 100 for the manifold 69 through the fluid delivery and gas venting device 60, e.g., micro-mini spike, and into the recipient container 58.
Depending upon the preparation parameters for a multi-dose container, e.g., desired final concentration of disperse radioactive liquid, the first control valve 52 may be opened so that additional saline solution from the first container 48 may be added to the final recipient container 58. If required, the first control valve 52 is opened by operation of the first drive mechanism 78 so that the nonradioactive liquid, e.g., saline solution, flows from the first container 48 to the third container 46, e.g., 35 mL syringe. If no additional saline solution is ever needed, the first control valve 52 is not opened and the third drive mechanism 80 is not activated.
The fifth step is that the fluid delivery and gas venting device 60, e.g., micro-mini spike is removed from the recipient container 58 by the first actuating mechanism 162 after the total volume of radioactive liquid, e.g., technetium, from the third container 46 and the nonradioactive liquid, e.g., saline solution, from the second container 44 is delivered to the recipient container 58.
After the recipient container 58, e.g., multi-dose vial, is filled to a predetermined level, the fluid delivery and gas venting device 60, e.g., micro-mini spike, is removed with the first actuating mechanism 162 and replaced with a new recipient container 58. Several of the recipient containers 58, e.g., vials, may be sequentially filled depending on the situation.
Completed multi-dose vials, containing radioactive liquid, e.g., technetium, are assayed for activity in a source calibrator (not shown) and labeled before dispensing individual unit dosages into syringes or before the multi-dose vial is shipped to a medical facility for use. All multi-dose vials are kept in lead containers or pigs 108 so that the radioactive material can be safely handled. The fluid delivery and gas venting device 60, e.g., micro-mini spike, is preferably changed afterward each drug type or flushed afterwards to prevent cross-contamination.
Although the preferred embodiment of the present invention and the method of using the same has been described in the foregoing specification with considerable details, it is to be understood that modifications may be made to the invention which do not exceed the scope of the appended claims and modified forms of the present invention done by others skilled in the art to which the invention pertains will be considered infringements of this invention when those modified forms fall within the claimed scope of this invention.
