Linearly motile infusion pump

Details Linearly motile infusion pump Linearly motile infusion pump

2000-05-01

2003-04-08

Lee, Kevin (Department: 3753)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S151000, C604S131000, C060S527000

Reexamination Certificate

active

06544229

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a medical pump and, more particularly, to an ambulatory infusion pump.
BACKGROUND OF THE INVENTION
Oftentimes, medical patients require precise delivery of continuous medication or at set periodic intervals. Certain liquid medicaments, or drugs, however, rarely achieve their maximum therapeutic action through conventional injection techniques. And, many drugs reach their full potential only through precise delivery over an extended period of time. Medical pumps have been developed to provide controlled drug infusion through the pump wherein the drug can be administered at a precise rate that keeps the drug concentration within the therapeutic margin and out of a possible toxic range with certain drugs. The medical pumps provide appropriate drug delivery to the patient at a controllable rate which does not require frequent medical attention. The medical pumps further facilitate administration of intravenous therapy to patients outside of a clinical setting. In addition, doctors have found that in many instances patients can return to substantially normal lives, provided that they can receive periodic or continuous intravenous administration of medication. These factors have combined to promote the development of increasingly lightweight, portable or ambulatory infusion pumps that can be worn by a patient and are capable of administering a continuous supply of medication at a desired rate.
A wide variety of ambulatory pumps in use in the medical field are intended to meet the need of a high degree of accuracy in the administration of fluids to maximize the effectiveness of medication and to protect the patient. Typically, these ambulatory infusion pumps include a pump control unit and a drive mechanism including a variety of operating controls adapted to accept a disposable pump chamber assembly. The pump chamber assembly has an inlet end connected to a liquid reservoir and an outlet end connected to an I.V. tube that in turn is connected for intravenous administration to a patient by a cannula.
Often, the same medical pump is programmable to allow for different pump application programs for pumping different therapeutics to a patient, such as antibiotic therapy, chemotherapy, pain control therapy, and nutritional therapy, etc. With regard to pain control therapy, medical infusion pumps are typically used for the management of acute pain, frequently in a hospital setting. These pumps deliver morphine or other analgesics to the patient, according to a pre-programmed prescription controlled by the pump. These pumps generally include various modes of infusion, such as a continuous mode in which the liquid medicament is continuously infused at a constant rate, or a ramp mode in which the rate of infusion gradually increases, then remains constant, and then gradually decreases. Further, these pumps include the capability for patient demand dosing. Typically, pain control therapy utilizing pumps having patient demand dosing capabilities is referred to as “PCA” or patient controlled analgesia.
With PCA, it is critical to carefully track the amount of drug a patient has received, the number of times the patient has requested additional demand doses, and the number of demand doses actually delivered to the patient, along with other information. Such historical information is utilized to adjust or “titrate” the patient's prescription. For such purposes, PCA infusion pumps have a non-volatile memory in which infusion parameters may be stored and from which such parameters may be retrieved. U.S. Pat. No. 5,181,910 discloses an infusion pump that is programmable and has an integral controller for automatically controlling and determining the interval between pump activations necessary to produce a substantially linear rate of increase or decrease in liquid flow during the administration of liquid medicament to a patient. The integral controller is a keypad on the face of the pump having keys which a clinician manually depresses to program the pump. These pumps also have a non-volatile memory in which such pump-specific infusion parameters may be stored and from which such parameters may be retrieved.
Typical parameters that these pumps, which have integral processors or controllers, are able to control include: the rate at which the medicament is infused, the volume or dosage of medicinal fluid administered, whether the drug is delivered as a bolus or continuous infusion, the time that the administration occurs, and/or the interval of time that the pump will operate. These parameters are usually entered into the electronic non-volatile memory of the pump controller via a user interface control panel on the pump (i.e., a keypad on the face of the pump). Although entry of the pump-specific parameters that control the pump's operation may be relatively straightforward, several minutes may be required to specify all of the data required to define a drug delivery protocol. More important, each time that a pump is programmed to administer a specific medicinal fluid, there is a risk that human error may cause improper values for the parameters to be entered.
In addition to historical “pump-specific” information, additional “patient-specific” information is required for the patient's medical chart. Thus, adequate monitoring of the drug pump and the patient's usage of the drug pump, along with monitoring of the patient, is still required. The combination of infusion data (i.e., “pump-specific” information) and patient data (i.e., “patient-specific” information) is necessary to generate a complete historical record or patient chart.
U.S. Pat. No. 5,795,327, owned by the Assignee of the present invention, discloses an infusion pump with historical data recording capabilities. The pump includes a controller integral with the pump to cause the pump to deliver a plurality of infusions of liquid medicament during the infusion period, each of the infusions being made at a specific time period and flow rate, and a keypad to allow a clinician to input the program parameters into the pump. The apparatus has a nonvolatile memory and means for storing infusion data in the non-volatile memory to generate a complete historical record of the “pump-specific” data including data regarding the infusions delivered during the infusion period. The “pump-specific” infusion data stored in the non-volatile memory may include programmed infusion data manually inputted to the infusion apparatus by a clinician during programming of the apparatus through the integral keypad controller. Such manually programmed infusion data may include data representing the infusion mode, the infusion flow rate, the volume to be infused, and the infusion start time. The infusion data may also include resulting data, including data representing the time at which each infusion was made during the infusion period and the flow rate at which of each infusion was made.
In addition to storing infusion data, the pump automatically records additional real-time infusion data (i.e., more “pump-specific” information). Such data includes the times at which the run and hold keys of the pump to control the infusion were pressed by the user, the time at which the bolus-request key was pressed, including bolus requests for PCA demand dosing, whether the bolus infusion was made as requested, the time at which any alarms or malfunctions occurred, data representing the type of alarm or malfunction, and data relating to the infusion modes which were locked out, if such means are available.
Automatic recording of the “pump-specific” infusion data described above in the non-volatile memory during the manual programing and operation of the infusion apparatus allows the operator to generate a historical data record of the apparatus. This data can later be retrieved from the non-volatile memory and used for various purposes, including clinical purposes, and to confirm that the prescribed infusion was actually delivered.
Additionally, U.S. Pat. No. 5,795,327 discloses the ability of the pump to present

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