Method and apparatus for ensuring sterility of disposable medical items used with medical equipment
First Claim
1. An apparatus to determine prior use of a disposable item utilized with a medical device comprising:
- a status device including a plurality of states and secured to said disposable item, wherein the state of said status device indicates a prior use of said disposable item; and
a processor coupled to said medical device and to said status device to determine said prior use of said disposable item based on said status device state and to facilitate control of medical device operation in accordance with said prior use determination, wherein said status device includes a conducting element disposed within an electrical path extending between said status device and said processor with a first state of said conducting element enabling said electrical path and indicating an unused disposable item and a second state of said conducting element disabling said electrical path and indicating prior use of that item, and wherein said processor includes;
a status module to transmit a status signal over said electrical path to said conducting element and to detect a return signal on said electrical path from said conducting element to determine said state of said conducting element and ascertain said prior use of said disposable item;
an element module to disable said electrical path by controlling said conducting element to enter said second state in response to detection of said return signal by said status module, thereby indicating use of said disposable item; and
a verification module to re-transmit said status signal over said electrical path to said conducting element in response to said disablement by said element module and to verify placement of the conducting element in said second state by said element module, wherein said verification module determines the presence of an unused disposable item with said conducting element in said second state in response to detection of the absence of said return signal and determines the presence of a used disposable item utilizing a conductive member with said conducting element in said second state in response to detection of said return signal.
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0 Petitions
Accused Products
Abstract
A disposable medical item for use with medical equipment includes circuitry forming an electrical path between the item and medical equipment. The circuitry is coupled to a medical equipment controller or independent microprocessor and includes a fuse. The controller transmits a status signal over the path in response to the equipment receiving the item. A disabled fuse prevents traversal of the path by the status signal, thereby indicating prior item use. If the controller does not detect the status signal, medical equipment operation is disabled. Otherwise, the controller transmits over the path a signal sufficient to disable the fuse to indicate item use and verifies the disabled fuse status. If the disabled fuse status is verified, the controller enables equipment operation. The controller periodically checks the fuse status during equipment operation and disables operation in response to a prior used item inserted into the medical equipment.
159 Citations
21 Claims
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1. An apparatus to determine prior use of a disposable item utilized with a medical device comprising:
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a status device including a plurality of states and secured to said disposable item, wherein the state of said status device indicates a prior use of said disposable item; and a processor coupled to said medical device and to said status device to determine said prior use of said disposable item based on said status device state and to facilitate control of medical device operation in accordance with said prior use determination, wherein said status device includes a conducting element disposed within an electrical path extending between said status device and said processor with a first state of said conducting element enabling said electrical path and indicating an unused disposable item and a second state of said conducting element disabling said electrical path and indicating prior use of that item, and wherein said processor includes; a status module to transmit a status signal over said electrical path to said conducting element and to detect a return signal on said electrical path from said conducting element to determine said state of said conducting element and ascertain said prior use of said disposable item; an element module to disable said electrical path by controlling said conducting element to enter said second state in response to detection of said return signal by said status module, thereby indicating use of said disposable item; and a verification module to re-transmit said status signal over said electrical path to said conducting element in response to said disablement by said element module and to verify placement of the conducting element in said second state by said element module, wherein said verification module determines the presence of an unused disposable item with said conducting element in said second state in response to detection of the absence of said return signal and determines the presence of a used disposable item utilizing a conductive member with said conducting element in said second state in response to detection of said return signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A medical device determining prior use of a disposable item utilized with that device to control device operation, wherein said disposable item includes a status device including a plurality of states and secured to said disposable item, and wherein the state of said status device indicates a prior use of said disposable item, said medical device comprising:
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a housing to receive and treat said disposable item; and a processor coupled to said status device to determine said prior use of said disposable item based on said status device state and to facilitate control of medical device operation in accordance with said prior use determination, wherein said status device includes a conducting element disposed within an electrical path extending between said status device and said processor with a first state of said conducting element enabling said electrical path and indicating an unused disposable item and a second state of said conducting element disabling said electrical path and indicating prior use of that item, and wherein said processor includes; a status module to transmit a status signal over said electrical path to said conducting element and to detect a return signal on said electrical path from said conducting element to determine said state of said conducting element and ascertain said prior use of said disposable item; an element module to disable said electrical path by controlling said conducting element to enter said second state in response to detection of said return signal by said status module, thereby indicating use of said disposable item; and a verification module to re-transmit said status signal over said electrical path to said conducting element in response to said disablement by said element module and to verify placement of the conducting element in said second state by said element module, wherein said verification module determines the presence of an unused disposable item with said conducting element in said second state in response to detection of the absence of said return signal and determines the presence of a used disposable item utilizing a conductive member with said conducting element in said second state in response to detection of said return signal. - View Dependent Claims (11, 12, 13, 14, 15)
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16. A method to determine prior use of a disposable item utilized with a medical device, wherein said disposable item includes a status device including a plurality of states with the state of said status device indicating a prior use of said disposable item and said medical device includes a processor coupled to said medical device and to said status device, said method comprising:
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(a) receiving the disposable item within said medical device, wherein said status device includes a conducting element disposed within an electrical path extending between said status device and said processor, and wherein a first state of said conducting element enables said electrical path and indicates an unused disposable item, and a second state of said conducting element disables said electrical path and indicates prior use of that item; and (b) determining said prior use of said disposable item, via said processor, based on said status device state and controlling medical device operation in accordance with said prior use determination, wherein step (b) further includes; (b.1) transmitting a status signal over said electrical path to said conducting element and detecting the presence of a return signal on said electrical path from said conducting element to determine said state of said conducting element and ascertain said prior use of said disposable item; (b.2) disabling said electrical path by controlling said conducting element to enter said second state in response to detection of said return signal in step (b.1), thereby indicating use of said disposable item; and (b.3) re-transmitting said status signal over said electrical path to said conducting element in response to said disablement in step (b.2) and verifying placement of the conducting element in said second state, wherein the presence of an unused disposable item with said conducting element in said second state is determined in response to detection of the absence of said return signal, and wherein the presence of a used disposable item utilizing a conductive member with said conducting element in said second state is determined in response to detection of the presence of said return signal. - View Dependent Claims (17, 18, 19)
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20. An apparatus to determine prior use of a disposable item utilized with a medical device comprising:
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status means secured to said disposable item for indicating a prior use of said disposable item and including a plurality of states, wherein the state of said status means indicates a prior use of said disposable item; and processing means coupled to said medical device and to said status means for determining said prior use of said disposable item based on said status means state and for facilitating control of medical device operation in accordance with said prior use determination, wherein said status means includes a conducting element disposed within an electrical path extending between said status means and said processing means with a first state of said conducting element enabling said electrical path and indicating an unused disposable item and a second state of said conducting element disabling said electrical path and indicating prior use of that item, and wherein said processing means includes; status signal means for transmitting a status signal over said electrical path to said conducting element and for detecting a return signal on said electrical path from said conducting element to determine said state of said conducting element and ascertain said prior use of said disposable item; element means for disabling said electrical path by controlling said conducting element to enter said second state in response to detection of said return signal by said status signal means, thereby indicating use of said disposable item; and verification means for re-transmitting said status signal over said electrical path to said conducting element in response to said disablement by said element means and for verifying placement of the conducting element in said second state by said element means, wherein said verification means determines the presence of an unused disposable item with said conducting element in said second state in response to detection of the absence of said return signal and determines the presence of a used disposable item utilizing a conductive member with said conducting element in said second state in response to detection of said return signal. - View Dependent Claims (21)
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Specification