Patent Grant
8535280
The present invention relates to implantable medical devices for delivering fluid to a target site within a patient. More particularly, it relates to systems, devices and methods for sensing and monitoring the withdrawal and filling of fluid into the medical device.
A variety of implantable infusion devices are available for treating patients. For example, implantable infusion devices are used for delivering therapeutic substances to a target location of a patient. The implantable infusion devices are implanted subcutaneously in a convenient location in the patient. An infusion catheter is connected to an outlet of the device and positioned in the patient to allow delivery to the target location. A therapeutic substance may then be introduced percutaneously into a reservoir of the implanted device by inserting a needle into a port assembly of the device and delivering a fluid containing the therapeutic substance to the device via the needle.
Because the device is implanted within the patient and cannot be seen directly, care must be taken to monitor the withdrawal and filling of the therapeutic substance into the reservoir. For example, when removing a drug from the reservoir it is advantageous to know when the all or substantially all of the drug has been removed. Moreover, it is additionally advantageous to know when the reservoir has been filled with the new drug.
A need therefore exists for a system capable of detecting the flow of therapeutic substance out of and into the reservoir of an implantable delivery device. A need also exists for indicating where the reservoir is substantially or completely full or empty.
The present disclosure describes, inter alia, systems, devices and methods that can be used to monitor the flow of a therapeutic substance, or other material such as a wash or rinse aid, into the reservoir of an implantable infusion device. The methods, systems and devices may be used to detect the flow into and out of the reservoir of the implantable infusion device. Moreover, the methods, systems and devices may be able to indicate a status such as “full” or “empty” when the material is reservoir is completely emptied or filled.
One embodiment may include a method for detecting fluid flow into and out of an implantable infusion device, the device including a port assembly defining the port chamber, the steps including sensing a pressure change in the port chamber, and determining whether the sensed pressure change is indicative of fluid flow into or out of the port chamber.
Another embodiment may be an implantable infusion device including a housing, a port assembly defining a port chamber, the port assembly being disposed in the housing such that the chamber is accessible by a needle inserted through the exterior of the housing, a pressure sensor in fluid communication with the port chamber, and electronics disposed in the housing and operably coupled to the pressure sensor, the electronics including a computer readable medium containing instructions that when implemented cause the device to detect, via the pressure sensor, a pressure fluctuation in the port chamber associated with a status of fluid flow into or out of the port chamber.
Another embodiment may be a method including inserting a needle into a patient to access a port chamber defined by a port assembly of an infusion device implanted in the patient, the port chamber being accessible from an exterior of the infusion device and being fluidly connected to a reservoir contained in the infusion device, sensing a pressure change in a port chamber or the reservoir, determining whether the sensed pressure change is indicative of a fluid flow status, and generating a sensory cue if the sensed pressure change is indicative of a fluid flow status.
The drawings are not necessarily to scale. Like numbers used in the figures refer to like components, steps and the like. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number.
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration several specific embodiments of devices, systems and methods. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense.
All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein and are not meant to limit the scope of the present disclosure.
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” encompass embodiments having plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
As used herein, “sensory cue” means a cue capable of being received by a person, such as an audible, tactile, or visual cue. A visual cue may include, for example, text or an image.
Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.
The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4.0, and 5.0) and any range within that range.
The present disclosure describes, inter alia, systems, devices and methods that can be used to detect the withdrawal and filling of a reservoir in an implantable medical device. Furthermore, the systems, devices and methods can detect when the reservoir reaches a substantially empty state or a substantially full state. As discussed herein, it has been discovered that a decrease in pressure can be detected when the therapeutic substance, or other material such as a wash or rinse aid, (collectively “material” or “fluid”), is being withdrawn from the reservoir or has been completely withdrawn using a needle or other device that accesses a port chamber. It has also be discovered that an increase in pressure can be detected when the reservoir is being filled or when the chamber becomes fully or substantially filled.
Referring to
As shown in
Infusion device 12 may be any device capable of delivering fluid to a patient. For example, infusion device 12 may be an access port, e.g. a vascular access port, through which bolus injections are delivered through a catheter to a patient. Infusion device 12 may also be a device having a reservoir for holding solutions containing therapeutic substances to be delivered over a period of time. Devices that deliver therapeutic substances over time may contain fixed or variable rate pumps, programmable pumps, or the like. An infusion device 12 having a reservoir will generally include a port assembly to allow for refilling of the reservoir.
The infusion device 12 shown in
While the discussion presented herein is primarily directed to infusion devices for delivering therapeutic substances to a patient, it will be recognized that the principles described herein may be advantageously applied to devices having port assemblies for the withdrawal of fluid from a patient.
Referring to
The therapeutic substance can be any infusion agent, product, or substance intended to have a therapeutic effect such as pharmaceutical compositions, genetic materials, biologics, and others (e.g., insulin, saline solution, fluoroscopy agents, etc.). Regardless, a pump and/or metering device (or “flow regulator”) (not shown) can be provided for dictating a flow of the therapeutic substance from reservoir 32 in a desired fashion. The pump/metering device can assume a variety of forms, and device 12 can further include a propellant chamber (not shown) associated with reservoir 32 for exerting a constant, positive pressure onto the reservoir 32 therapeutic substance to ensure delivery to the outlet catheter 34. In other embodiments, the pump/metering device can be eliminated.
In the present embodiment, infusion device 12 may include a fill port assembly 40 fluidly connected to, and otherwise defining an inlet of, reservoir 32. In more general terms, however, fill port assembly 40 may assume a conventional configuration whereby a septum 42 seals a port chamber 44 relative to an exterior of the housing 30. Port chamber 44, in turn, is in fluid communication with reservoir 32 (e.g., a permanent fluid connection is established and a valve means is provided that actuates to selectively fluidly connect port chamber 44 and reservoir 32, etc.). Needle 20 may percutaneously deliver a liquid to port assembly 40, and in particular through septum 42 and into port chamber 44, as part of a reservoir 32 refilling operation. The therapeutic substance may then be pushed to the reservoir 32. In the present embodiment, the pressure in the reservoir 32 is less than ambient atmospheric pressure and so the needle 20 does not need to be actuated but rather the ambient atmospheric pressure initiates and sustains the flow of fluid into the reservoir 32. In further embodiments pressure may be placed on a plunger of the syringe and therefore a higher pressure may be exerted on the reservoir.
Referring to
Regardless of the embodiment depicted, infusion device 12 may include additional components as known conventionally or developed in the future. For example, infusion device 12 can include a controller 46 or other electronics, for example in the form of a digital microprocessor, although any equivalent device may be substituted for a digital microprocessor; in many instances, it may also be desirable that the controller 46 includes data storage capabilities. Where provided, the controller 46 (as well as other components) can be powered by a power supply 48 (that may be preferably in the form of a battery or other self-contained power source). Other components can further be provided with infusion device 12 that are not otherwise illustrated, such as safety valves, flow restrictors, etc., that may enhance operation of the infusion device 12.
With the above general construction of the infusion device 12 in mind, a pressure sensor 14 may be maintained by housing 30, and may be operably situated between port assembly 40 and reservoir 32 (see, e.g.,
As depicted in the embodiments shown in
With reference to the embodiments depicted in
In various embodiments, pressure sensor 14 is electronically coupled to telemetry circuitry 50 (for example, via a controller (not shown)), with pressure-related information generated by pressure sensor 14 being signaled to external programmer 62. External programmer 62 may include a detector circuit 50 and a logic circuit that interprets and then displays the information collected by the pressure sensor 14.
The parameters under which detector circuit 50 will prompt operation of the indicator device 60 are described in greater detail below. In one embodiment, indicator device 60 is a display screen adapted to display information to the clinician. As is known in the art, a display screen is commonly provided with an external programmer 62 (e.g., an N'Vision™ Programmer available from Medtronic, Inc., of Minneapolis, Minn. as part of the SynchroMed® II Infusion System), and can display information in a variety of fashions, for example, with text, pictures, symbols, graphical information, etc. Indicator device 60 can further include a sensory cue generator, such as sound generator, as previously described. In one embodiment, upon determining that pressure-related information generated by pressure sensor 14 is indicative of some flow state of the therapeutic substance, detector circuit 50 prompts indicator device 60 to inform the clinician via the display screen, sound generating device, or the like. In other embodiments, detector circuit 50 can be eliminated with indicator device 60 simply displaying a current pressure reading provided by the pressure sensor 14. Under these conditions, the clinician can make a self-evaluation as to whether the sensed and displayed pressure is indicative of withdrawal, fill, empty, or full states.
With the above description in mind,
In various embodiments, port assembly 40 may further include a septum plug 74 used to retain septum 42 while providing a fluid-tight seal. Septum plug 74 may define the port chamber 44 to include drain holes 78 that allow fluids delivered to port chamber 44 to pass into reservoir 32. In some embodiments, a valve feature (not shown) can be provided to further control flow of liquid from port chamber 44 to reservoir 32 as is known in the art. In still further embodiments the drain holes 78 may lead to a passage (not shown) that then leads to the reservoir 32. The septum 42 may define a first exterior side 80 and a second or interior side 82. Exterior side 80 is exposed relative to opening 70 of housing 30, whereas interior side 82 defines a portion of port chamber 44. While
With the above conventions in mind, pressure sensor 14 may, in various embodiments, be associated with port assembly 40, and in particular port chamber 44, by placing the pressure sensor 14 along an interior of a wall of septum plug 74. In other embodiments, pressure sensor 14 may be disposed within a thickness of septum plug 74 (such as by forming (e.g., overmolding) septum plug 74 about pressure sensor 14). Even further, pressure sensor 14 may be assembled to an exterior of septum plug 74 (relative to the port chamber 44). In further embodiments the pressure sensor 14 is placed in the drain holes 78 or the passage that lead to the reservoir 32.
Pressure sensor 14 may be a variety of different forms. For example, pressure sensor 14 may be a capacitive measurement device which determines pressure by measuring the change in capacitance of a flexible membrane attached but insulated from a conductive, gas-filled cavity due to deflections caused by pressure applied over the flexible membrane. Alternatively, pressure sensor 14 may be a sensor that utilizes the piezo-electric effect or resistive change due to metallic strain in order to measure pressure applied. Regardless of the specific manner in which pressure sensor 14 measures pressure, in various embodiments, pressure sensor 14 is adapted to generate a signal indicative of a pressure of port chamber 44. Alternatively, pressure sensor 14 may be adapted to generate a signal indicative of a change in pressure of port chamber 44. Pressure sensor 14 may be any device capable of sensing and signaling information indicative of pressure characteristics associated with port chamber 44 or the passage between the port chamber 44 and the reservoir 32. Pressure sensor 14 may be electronically coupled to detector circuit 50 or indicator device 16, 60 in a variety of ways. For example, electrical wiring (not shown) can provide the desired electrical connection. Alternatively, a wireless link may be provided between pressure sensor 14 and the processing device and/or display device selected.
In general terms and without being bound by the following description, it is believed that withdrawal or filling of therapeutic substance from the reservoir 32 causes the pressure profile existing in the fluid system to fluctuate from a normal state. In addition, when the reservoir 32 reaches an empty or full state, or a substantially empty or full state, or when the needle 20 is inserted or when clamps are opened and closed, the pressure profile may also change.
Referring to
The pressure profiles depicted in
The normal pressure indicated by the pressure sensor 14 in the present embodiment infusion pump 12 is approximately 490 mmHg (about 9.5 pounds per square inch (psi)) as the present embodiment infusion pump 12 is a negative pressure pump wherein the fluid in the reservoir 32 and the port chamber 44 are kept at a pressure below normal atmospheric pressure, about 760 mmHg (about 14.7 psi). Position A on the graph shows a pressure spike when the needle 20 is inserted into the port chamber 44. In the present embodiment, the needle is connected to a tubing or hose that, during the initial insertion, is clamped off from a needle reservoir into which the fluid from the reservoir 32 will be drained or from which the fluid will be placed into the reservoir 32. Position B indicates another pressure spike when the clamp on the tubing separating the needle 20 from the needle reservoir is unclamped or released. In the presently described method the needle reservoir is empty and the fluid in the infusion pump 12 reservoir 32 will be removed before new fluid with therapeutic substance contained therein is placed therein.
As illustrated at point C, when the syringe is withdrawn to create a low pressure in the needle reservoir and to draw the fluid from the reservoir 32, a relatively rapid drop in pressure is detected by the pressure sensor 14. Fluid will begin to flow out of the reservoir 32 and the port chamber 44 at a steady rate that depends on the degree of low pressure created in the needle reservoir. Point D on the pressure graph illustrates a pressure decrease during the withdrawal, or aspiration, phase, of the fluid from the reservoir 32.
As may be appreciated, the steady state infusion pump 12 reservoir 32 will try to compensate and maintain the pre-programmed pressure in the reservoir 32. As the reservoir empties, the pressure will drop, but within a specific range as shown at point D. Therefore, the pressure will slowly drop as shown at point D. However, at some point the reservoir 32 will no longer be able to maintain the pressure as too little fluid will remain in the reservoir 32. When the reservoir 32 is at or near an empty state, the reservoir 32 and pressure compensation system of the infusion pump 12 may no longer be able to keep an elevated pressure, and the pressure will quickly drop as illustrated at point E. In the present embodiment the reservoir 32 may undergo the non-linear pressure behavior illustrated in
Point G illustrates a relatively slow increase in the detected pressure towards the nominal pressure after the reservoir 32 is emptied and the tubing has been clamped. The increase in the detected pressure may be in part due to the inability of the pump to perfectly hold a vacuum. Micro amounts of gas may permeate through the septum.
Point I illustrates where the tubing is unclamped such that the pressure from the refill syringe containing fluid for filling the reservoir 32 is transferred to port chamber 44 and reservoir 32 and detected by the pressure sensor 14. At point J a rapid rise in pressure is shown. In the present embodiment, the pressure in the fluid in the refill syringe is at atmospheric pressure. The pressure inside the reservoir 32 is set below this and so as the atmospheric pressure (760 mmHg) of the fluid enters the reservoir 32 the reservoir tries to compensate and return to the lower selected pressure. Point K shows the reservoir and propellant equalizing the pressure back to the predetermined nominal state. However, in present embodiment the pressure may slowly rise such as at point L as the reservoir 32 is filled. As may be appreciated, if pressure were to be applied to a syringe plunger to increase the flow rate into the infusion pump 12, the pressure exerted may be significantly higher.
In the present embodiment, when the reservoir 32 has expanded to such a point wherein the pressure in the reservoir 32 exceeds some predetermined level, an over pressure mechanism may engage to stop the flow of fluid into the reservoir 32. Point M shows the pressure spike as the reservoir reaches a full state. Point N is the point at which the clamp on the tubing is reset. The pressure detected may then fall again as the reservoir continues to work to adjust the internal pressure to that selected level. Point P shows where the needle 20 is removed and the filling operation is complete.
As can be seen from
In light of the above,
With the above discussion in mind,
One of skill in the art will understand that components or steps described herein regarding a given embodiment or set of embodiments may readily be omitted, substituted, or added from, with, or to components or steps of other embodiments or sets of embodiments, as appropriate or desirable.
This application claims priority to provisional U.S. application Ser. No. 60/975,286, filed Sep. 26, 2007.
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