Patent Application
20130023820
1. Field of the Invention
The present invention relates to medical systems, and particularly to a patient-controlled analgesia (PCA) safety system that automatically prevents potential adverse effects of the analgesic or the unintended misuse or overdose thereof.
2. Description of the Related Art
Postoperative patients generally suffer a great deal of pain as a result of the surgical procedure. The physician usually prescribes strong analgesics or painkillers in the form of pills or tablets to relieve this symptom for most patients. For some extreme cases, more powerful analgesics are prescribed which can be self-administered by the patient through a PCA device or pump. The typical PCA device is programmed to deliver a predetermined amount of opiate, such as morphine, through a connected intravenous tube whenever the patient presses a button according to the patient's perceived needs. While the PCA device relieves pressure on nursing resources and grants superior pain control, the patient could easily induce an accidental overdose if the administration of the analgesic is left unchecked or if the patient is hypersensitive to the analgesic. Most PCA devices include some type of safety system that helps prevent such dangers, an example of which is a time delay, either programmed or built into the device. The time delay prevents the device from processing another dose before the specified delay has lapsed.
Despite these safeguards, accidental overdoses can still occur, and the typical PCA device still lacks a more active approach in preventing the overdose or other drug related complications. Like most devices, a PCA pump is prone to operator error. For example, a nurse who prepares the PCA device for patient use may inadvertently install a cartridge or vial that contains a higher concentration of analgesic than prescribed, e.g., a 5 mg/mL versus a 1 mg/mL. This can lead to an overdose, even on the first charge. Moreover, the physiology of everyone is not the same. A certain dosage for one may not result in the same pain relief for another. Some may even be allergic to certain drugs and/or concentrations thereof without prior knowledge to themselves or to the physician. Whatever complications may arise, a typical PCA device does not have the means to overcome these types of issues with any alacrity. Failure to respond timely in those situations can ultimately lead to the death of the patient.
In light of the above, it would be a benefit in the medical arts to provide a self-administering drug delivery system with safety features capable of preventing overdose and responding to other emergencies in a timely manner. Thus, a patient-controlled analgesia safety system solving the aforementioned problems is desired.
The patient controlled analgesia safety system includes a housing with a hollow compartment. A display and keypad are disposed on one side of the housing for display of monitoring data and selective commands respectively. An analgesic module and an antidote module are detachably mounted inside the compartment. A control module is disposed inside the housing. A vital signs monitor is connected to the control module to monitor a patient. In the event of abnormal readings due to, e.g., overdose or drug related complications, the control module can automatically administer an antidote to the analgesia. The control module can also alert a nurse monitor and/or other personnel wirelessly to insure someone is notified of the potential emergency. The PCA safety system can also be provided in a separate safety module having a detachably mounted antidote module.
These and other features of the present invention will become readily apparent upon further review of the following specification and drawings.
Similar reference characters denote corresponding features consistently throughout the attached drawings.
The patient-controlled analgesia (PCA) safety system, generally referred to by the reference number 10 in the drawings, includes a variety of features for timely response to many drug related emergency situations, both in hospitals and at home. As shown in
The control panel 14 includes a keypad 24 and a display monitor 22. The control panel 14 allows the user to input various commands and program the device. For example, depending on the prescription, the nurse or physician may set the minimum time intervals before another dose of analgesic can be self-administered by the patient. Other parameters that can be adjusted include the rate in which certain physical conditions are being monitored, the number of doses allowed prior to complete lockout of further doses for a predetermined period of time, the name and other personal data of the patient, and the name of the physician in charge of the patient. All or some of that information can be displayed on the monitor 22. The monitor 22 can be a color or monochromatic LCD (liquid crystal display) capable of displaying the above information. As a non-limiting alternative, the keypad 24 may be a touchpad or an alphanumeric pad incorporated into the monitor 22 as a graphical interface accessible via a touchscreen.
The analgesic module 18 disposed in the dispenser 12 can be provided in the form of a cartridge 25. The cartridge 25 includes a vial, ampoule, canister or container 26 filled with the prescribed analgesic. A first or primary intravenous line 19 connects the contents of the vial 26 to the user or patient allowing for selective delivery of the analgesic whenever the user or patient activates the dispenser 12 via the patient-controlled actuator 30, usually a hand-held control with a button. The cartridge 25 allows for more easy preparation and installation of the drug.
One of the many safety features of the PCA safety system 10 lies in the antidote module 20. In this non-limiting exemplary embodiment, the antidote module 20 can be provided in the form of an antidote cartridge 27 detachably mounted in the dispenser 12 in the same manner as the analgesic cartridge 25. The antidote cartridge 27 includes a vial, ampoule, canister or container 28 tilled with an antidote for the analgesic contained in the analgesic vial 26. The antidote can be Naloxone™, an opioid antagonist or any other drug or chemical compound that counteracts the effects of the analgesic in the event of an overdose. A second intravenous line 21 connects the contents of the antidote vial 28 to the first intravenous line 19 to facilitate delivery of the antidote.
The operation and medical alerts of the PCA safety system 10 are controlled by the control module 16. As schematically shown in
In the event of abnormal readings from the vital signs monitor 40 indicative of potential analgesic or drug related complications, the PCA safety system 10 is preferably programmed so that the processor 50 discontinues any further attempts to self-administer the analgesic. If abnormal readings persist after a brief, predetermined interval, e.g., 30 seconds or less, then the processor 50 automatically transmits an alert to the nurse monitor 60 through the wireless transmitter 54 along with data from the vital signs monitor 40. At the same time, the processor 50 automatically activates the antidote module 20 to deliver the antidote to the patient.
The above may be sufficient to counteract the immediate danger and stabilize the patient. However, the patient must be examined by professionals to determine the extent of the emergency. To insure that someone is notified, the PCA safety system 10 includes several redundant safety features. One of the redundant features is in who receives the wireless transmission. If for some reason the nurse at the nurse monitor 60 is not able to respond timely to the alert, the processor can be programmed to transmit the alert to other personnel 62 such as an emergency response, the physician in charge, and family members in a selected priority list. In this manner, even if the healthcare professionals on site and primarily responsible do not respond immediately or timely, the physician or one of the patient's family members can notify someone at the patient's location of the emergency.
Another redundancy lies in safeguards against system component failure. In the event the wireless transmitter malfunctions or fails, a backup transmitter 56 is activated by the processor 50. In the non-limiting exemplary embodiment, the backup transmitter 50 is preferably capable of both landline and wireless transmissions for insuring the transmission reaches the desired recipients or receivers. A backup power source 58 is provided as a countermeasure against inadvertent power failure. The backup power source 58 supplies power to the processor 50 and/or the backup transmitter 56 for continuous functioning of the control module 16. The backup power source 58 is preferably a rechargeable and re-useable battery.
While the above describes the PCA safety system 10 as a PCA device with integrated safety features, the PCA safety system 10 may also be provided in a modular system. As shown in the non-limiting alternative embodiment in
The safety module 102 includes the control module 16 described above, the control module 16 being incorporated into the body of the safety module 102. The medical parameters of the patient can be obtained from existing monitoring equipment or from the integrated sensors of the control module. Once attached to an existing PCA device, the safety module 102 can be connected to a data port on the PCA device such that the safety module 102 can override, at the very least, further administration of the analgesic and/or power of the PCA device.
The safety module 102 can be used alone to help monitor the patient's reaction to the analgesia and facilitate notification of any drug related complications to the proper authorities or family. However, to be more effective, the PCA safety system 100 can include an antidote module 110 detachably mounted to the safety module 102. The antidote module 110 includes an antidote contained in a vial, ampoule or canister 112. The antidote is selectively and automatically administered by the processor 50 in response to the potential emergency conditions noted above.
Thus, it can be seen that the PCA safety system 10, 100 includes many safety features that can overcome a majority of analgesic or drug related complications. The antidote module 20, 110 provides an immediate countermeasure to a potential overdose, The control module 50 and the many redundant features insure that someone is notified of the patient's condition. Moreover, the various configurations allows the PCA safety system 10, 100 to be utilized in a wide range of facilities from a home setting to a state of the art hospital.
It is to be understood that the PCA safety system 10, 100 encompasses a wide variety of alternatives. For example, the PCA safety system 10, 100 is not limited to patient-controlled analgesia devices. The teachings thereof can be applied to any self-controlled or self-administered drug delivery systems such as an automated insulin pump and the like.
It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/510,400, filed Jul. 21, 2011.
| Number | Date | Country | |
|---|---|---|---|
| 61510400 | Jul 2011 | US |
