Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-04-21
2002-10-29
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S030000, C604S043000, C604S284000, C604S533000, C604S256000
Reexamination Certificate
active
06471674
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to fluid delivery systems, to injector systems, and to methods of delivering fluids, and, more particularly, to multipatient fluid delivery systems, to multipatient injector systems and to methods of multipatient fluid delivery for use in medical procedures in which a fluid is delivered at a relatively high pressure.
BACKGROUND OF THE INVENTION
In many medical procedures, such as drug delivery, it is desirable to inject a fluid into a patient. Likewise, numerous types of contrast media (often referred to simply as contrast) are injected into a patient for many diagnostic and therapeutic imaging procedures. In some medical imaging procedures (for example, computed tomography (CT), angiography, ultrasound and nuclear magnetic resonance/magnetic resonance imaging (MRI)), it is desirable to deliver a liquid such as contrast medium in a timed fashion under relatively high pressures. Such relatively high pressures and timed boluses are typically achieved through the use of powered injectors.
To, for example, optimize contrast volume delivery, minimize waste of contrast and facilitate injector procedures for operators, fluid delivery systems that are capable of delivering sufficient contrast for multiple injection procedures from a single source of contrast have recently been developed. Examples of such systems are described generally in U.S. Pat. Nos. 5,569,181, 5,806,519, 5,843,037 and 5,885,216, the disclosures of which are incorporated herein by reference. Typically, it is desirable that such fluid delivery systems include a fluid path with a disposable patient interface that is changed/discarded between each patient to reduce the potential for cross-contamination.
A fluid path connector is required to incorporate a removable/disposable patient interface in the fluid path of a fluid delivery or injector system. However, many fluid path connectors used in medical procedures exhibit a number of substantial drawbacks including, for example, difficulty of use and difficulty in maintaining sterility. Moreover, when such connectors are used at high pressures, leakage and failure also become substantial problems.
It is very desirable to develop fluid delivery systems including fluid path connections for use at relatively high pressures that reduce or eliminate the drawbacks associated with current connectors and systems.
SUMMARY OF THE INVENTION
The present invention provides a fluid delivery system for injecting an injection fluid into a patient that includes generally: a first pump system to pressurize the injection fluid; a patient interface in removable fluid connection with the first pump system; and a fluid path in fluid connection between the first pump system and the patient interface. The fluid path preferably includes a connector. The first pump system is in fluid connection with an inlet of the connector. The patient interface is in removable fluid connection with an outlet of the connector. The connector preferably includes a sealing member at least partly disposed within a housing of the connector that is biased to close the outlet when the patient interface is disconnected from the connector. As used herein, the term “connection” and the phrase “fluid connection” encompasses both direct and indirect connection and/or fluid connection.
The sealing member preferably extends from an interior of the housing of the connector when the patient interface is disconnected therefrom to be at least generally flush with the outlet of the connector to facilitate aseptic cleaning of an outward facing surface of the sealing member. The sealing member preferably prevents contaminants from entering the interior of the connector housing when the patient interface is disconnected from the connector. Preferably, an increase of pressure within the connector housing acts to improve a seal created by the sealing member when the patient interface is disconnected from the connector. For example, such a pressure increase can increase the force with which the sealing member is biased to close the outlet of the connector.
In one aspect of the present invention, the first pump system is a syringe that includes sufficient injection fluid for multiple injection procedures. The syringe can, for example, be a prefilled, disposable syringe.
The fluid delivery system can further include a second pump system to pressurize a fluid other than the injection fluid (for example, saline). The second pump system is preferably in fluid connection with the patient interface through the connector.
An outlet of the first pump system is preferably in fluid connection with a first check valve to control flow of fluid into the first pump system. Likewise, an outlet of the second pump system is preferably in fluid connection with a second check valve to control flow of fluid into the second pump system.
The present invention also provides a kit for use in a procedure in which an injection fluid is delivered to a patient. The kit includes generally: a first syringe preferably having a volume to contain sufficient injection fluid for at least two injection procedures; at least one patient interface adapted to be in fluid connection with the patient; and a fluid path adapted to removably connect the patient interface to the first syringe. The fluid path preferably includes a connector having an outlet adapted to removably connect the patient interface thereto. The connector preferably further includes an inlet adapted to connect the connector to the first syringe.
As described above, the connector may include a sealing member at least partly disposed within a housing of the connector that is biased to close the outlet when the patient interface is not attached to the connector. Preferably, the first syringe is prefilled with sufficient injection fluid for at least two injection procedures. Preferably, the kit includes multiple patient interfaces. The kit can also include a second syringe for injecting a fluid (for example, saline) other than the injection fluid.
The present invention also provides an injector system for injection of a fluid into a patient. The injector system includes generally: a powered injector including a first drive member; a first syringe including a first plunger slidably disposed therein, the first syringe being connected to the powered injector such that the first drive member can impart powered motion to the first plunger; a patient interface in removable fluid connection with the first syringe; and a connector as described above. The injector system can further include a second syringe having a second plunger slidably disposed therein. The second plunger is in powered connection with a second drive member of the powered injector. The second syringe can, for example, be adapted to inject saline into the patient. Like the first syringe, the second syringe is preferably in fluid connection with the patient interface through the connector.
The present invention further provides a method of injecting a fluid into multiple patients including the steps of: providing a first pump system containing fluid sufficient to inject at least two patients, the first pump system adapted to pressurize the injection fluid; providing a connector in fluid connection with the first pump system, the connector including a housing having an inlet, an outlet and a sealing member at least partly disposed within the housing, the sealing member being biased to close the outlet to prevent fluid flow out of or into the first pump system; providing a patient interface operable to be removably connected to the outlet of the connector to deliver the fluid to a patient; removably connecting the patient interface to the outlet of the connector, whereby the patient interface opens the sealing member to create a fluid path from the first pump system to the patient; and injecting fluid from the first pump system into the patient. In one aspect, the first pump system is a syringe prefilled with sufficient injection fluid for at least two injection procedures.
The method preferably furthe
Callan Gerald W.
Emig Michael F.
Havrilla Joseph B.
Rhinehart Edward J.
Trombley, III Frederick
Bradley Gregory L.
Dahbour Fadi H.
Medrad Inc.
Walberg Teresa
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