Not Applicable
A cannula 20 is typically used for administering fluid via a subcutaneous blood vessel V. Typically, cannula 20 is inserted through skin S at a cannulation or cannula insertion site N and punctures the blood vessel V, for example, the cephalic vein, basilica vein, median cubital vein, or any suitable vein for an intravenous infusion. Similarly, any suitable artery may be used for an intra-arterial infusion.
Cannula 20 typically is in fluid communication with a fluid source 22. Typically, cannula 20 includes an extracorporeal connector, e.g., a hub 20a, and a transcutaneous sleeve 20b. Fluid source 22 typically includes one or more sterile containers that hold the fluid(s) to be administered. Examples of typical sterile containers include plastic bags, glass bottles or plastic bottles.
An administration set 30 typically provides a sterile conduit for fluid to flow from fluid source 22 to cannula 20. Typically, administration set 30 includes tubing 32, a drip chamber 34, a flow control device 36, and a cannula connector 38. Tubing 32 is typically made of polypropylene, nylon, or another flexible, strong and inert material. Drip chamber 34 typically permits the fluid to flow one drop at a time for reducing air bubbles in the flow. Tubing 32 and drip chamber 34 are typically transparent or translucent to provide a visual indication of the flow. Typically, flow control device 36 is positioned upstream from drip chamber 34 for controlling fluid flow in tubing 34. Roller clamps and Dial-A-Flo®, manufactured by Hospira, Inc. (Lake Forest, Ill., USA), are examples of typical flow control devices. Typically, cannula connector 38 and hub 20a provide a leak-proof coupling through which the fluid may flow. Luer-Lok™, manufactured by Becton, Dickinson and Company (Franklin Lakes, N.J., USA), is an example of a typical leak-proof coupling.
Administration set 30 may also include at least one of a clamp 40, an injection port 42, a filter 44, or other devices. Typically, clamp 40 pinches tubing 32 to cut-off fluid flow. Injection port 42 typically provides an access port for administering medicine or another fluid via cannula 20. Filter 44 typically purifies and/or treats the fluid flowing through administration set 30. For example, filter 44 may strain contaminants from the fluid.
An infusion pump 50 may be coupled with administration set 30 for controlling the quantity or the rate of fluid flow to cannula 20. The Alaris® System manufactured by CareFusion Corporation (San Diego, Calif., USA) and Flo-Gard® Volumetric Infusion Pumps manufactured by Baxter International Inc. (Deerfield, Ill., USA) are examples of typical infusion pumps.
Intravenous infusion or therapy typically uses a fluid (e.g., infusate, whole blood, or blood product) to correct an electrolyte imbalance, to deliver a medication, or to elevate a fluid level. Typical infusates predominately consist of sterile water with electrolytes (e.g., sodium, potassium, or chloride), calories (e.g., dextrose or total parenteral nutrition), or medications (e.g., anti-infectives, anticonvulsants, antihyperuricemic agents, cardiovascular agents, central nervous system agents, chemotherapy drugs, coagulation modifiers, gastrointestinal agents, or respiratory agents). Examples of medications that are typically administered during intravenous therapy include acyclovir, allopurinol, amikacin, aminophylline, amiodarone, amphotericin B, ampicillin, carboplatin, cefazolin, cefotaxime, cefuroxime, ciprofloxacin, cisplatin, clindamycin, cyclophosphamide, diazepam, docetaxel, dopamine, doxorubicin, doxycycline, erythromycin, etoposide, fentanyl, fluorouracil, furosemide, ganciclovir, gemcitabine, gentamicin, heparin, imipenem, irinotecan, lorazepam, magnesium sulfate, meropenem, methotrexate, methylprednisolone, midazolam, morphine, nafcillin, ondansetron, paclitaxel, pentamidine, phenobarbital, phenytoin, piperacillin, promethazine, sodium bicarbonate, ticarcillin, tobramycin, topotecan, vancomycin, vinblastine and vincristine. Transfusions and other processes for donating and receiving whole blood or blood products (e.g., albumin and immunoglobulin) also typically use intravenous infusion.
Unintended infusing typically occurs when fluid from cannula 20 escapes from its intended vein/artery. Typically, unintended infusing causes an abnormal amount of the fluid to diffuse or accumulate in perivascular tissue P and may occur, for example, when (i) cannula 20 causes a vein/artery to rupture; (ii) cannula 20 improperly punctures the vein/artery; (iii) cannula 20 backs out of the vein/artery; (iv) cannula 20 is improperly sized; (v) infusion pump 50 administers fluid at an excessive flow rate; or (vi) the infusate increases permeability of the vein/artery. As the terminology is used herein, “tissue” preferably refers to an association of cells, intercellular material and/or interstitial compartments, and “perivascular tissue” preferably refers to cells, intercellular material and/or interstitial compartments that are in the general vicinity of a blood vessel and may become unintentionally infused with fluid from cannula 20. Unintended infusing of a non-vesicant fluid is typically referred to as “infiltration,” whereas unintended infusing of a vesicant fluid is typically referred to as “extravasation.”
The symptoms of infiltration or extravasation typically include blanching or discoloration of the skin S, edema, pain, or numbness. The consequences of infiltration or extravasation typically include skin reactions such as blisters, nerve compression, compartment syndrome, or necrosis. Typical treatment for infiltration or extravasation includes applying warm or cold compresses, elevating an affected limb, administering hyaluronidase, phentolamine, sodium thiosulfate or dexrazoxane, fasciotomy, or amputation.
Embodiments according to the present invention include a sensor that includes a first optical fiber, a second optical fiber, and a housing. The first optical fiber includes a first end face emitting a first near-infrared signal into a body. The second optical fiber includes a second end face detecting a second near-infrared signal from the body. The second near-infrared signal including a first portion of the first near-infrared signal that is at least one of reflected, scattered and redirected in the body. The housing includes a surface overlying the body and a near-infrared energy absorber. The surface cinctures the first and second end faces. The near-infrared energy absorber absorbs a third near-infrared signal impinging on the surface. The third near-infrared signal includes (i) a second portion of the first near-infrared signal that is at least one of reflected, scattered and redirected in the body and (ii) a third portion of the first near-infrared signal that is reflected in an imperfect cavity between the surface and the body.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate exemplary embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features, principles, and methods of the invention.
In the figures, the thickness and configuration of components may be exaggerated for clarity. The same reference numerals in different figures represent the same component.
The following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description.
Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment according to the disclosure. The appearances of the phrases “one embodiment” or “other embodiments” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various features are described which may be included in some embodiments but not other embodiments.
The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Certain terms in this specification may be used to provide additional guidance regarding the description of the disclosure. It will be appreciated that a feature may be described more than one-way.
Alternative language and synonyms may be used for any one or more of the terms discussed herein. No special significance is to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any exemplified term.
Preferably, electromagnetic energy sensor 1000 includes a structural sensor. As the terminology is used herein, a “structural sensor” preferably is concerned with sensing a change over time in the arrangement of the body. Unintended accumulation of a fluid in the body is an example of a structural change over time. By comparison, a functional sensor is concerned with sensing the activity level of the body at a point in time. Fluid flow through the body is an example of a function of the body at a point in time.
Electromagnetic energy sensor 1000 preferably is arranged to overlie a target area of the outer layer s. As the terminology is used herein, “target area” preferably refers to a portion of the outer layer s that is generally proximal to a volume of interest p within the body. Preferably, the target area overlies the volume of interest p.
Electromagnetic energy sensor 1000 preferably uses electromagnetic radiation to aid in identifying fluid accumulation in the body over time. Preferably, electromagnetic energy sensor 1000 includes an electromagnetic radiation signal transmitter 1002 and an electromagnetic radiation signal receiver 1004. Electromagnetic radiation signal transmitter 1002 preferably includes an emitter face 1002a for emitting electromagnetic radiation 1002b and electromagnetic radiation signal receiver 1004 preferably includes a detector face 1004a for detecting electromagnetic radiation 1004b. According to one embodiment, electromagnetic radiation signal transmitter 1002 preferably includes a set of first optical fibers and electromagnetic radiation signal receiver 1004 preferably includes a set of second optical fibers. Individual optical fibers in the first or second sets preferably each have end faces that form the emitter or detector faces, respectively. Preferably, emitted electromagnetic radiation 1002b from emitter face 1002a passes through the target area of the outer layer s toward the volume of interest p. Detected electromagnetic radiation 1004b preferably includes at least a first portion of emitted electromagnetic radiation 1002b that is at least one of specularly reflected, diffusely reflected (e.g., due to scattering), fluoresced (e.g., due to endogenous or exogenous factors), or otherwise redirected from the volume of interest p before passing through the target area of the outer layer s to detector face 1004a. Preferably, an accumulation of fluid in the volume of interest p affects the absorption and/or scattering of the first portion of emitted electromagnetic radiation 1002b and accordingly affects detected electromagnetic radiation 1004b. Accordingly, electromagnetic energy sensor 1000 preferably senses changes in detected electromagnetic radiation 1004b that correspond with a structural change over time, e.g., fluid accumulation in the volume of interest p.
Emitted and detected electromagnetic radiations 1002b and 1004b preferably are in the near-infrared portion of the electromagnetic spectrum. As the terminology is used herein, “near infrared” preferably refers to electromagnetic radiation having wavelengths between approximately 600 nanometers and approximately 2,100 nanometers. These wavelengths correspond to a frequency range of approximately 500 terahertz to approximately 145 terahertz. A desirable range in the near infrared portion of the electromagnetic spectrum preferably includes wavelengths between approximately 800 nanometers and approximately 1,050 nanometers. These wavelengths correspond to a frequency range of approximately 375 terahertz to approximately 285 terahertz. Emitted and detected electromagnetic radiations 1002b and 1004b preferably are tuned to a common peak wavelength. According to one embodiment, emitted and detected electromagnetic radiations 1002b and 1004b each have a peak centered about a single wavelength, e.g., approximately 970 nanometers (approximately 309 terahertz). According to other embodiments, emitted electromagnetic radiation 1002b includes a set of wavelengths in a band between a relatively short wavelength and a relatively long wavelength, and detected electromagnetic radiation 1004b encompasses at least the band between the relatively short and long wavelengths. According to still other embodiments, detected electromagnetic radiation 1004b is tuned to a set of wavelengths in a band between a relatively short wavelength and a relatively long wavelength, and emitted electromagnetic radiation 1002b encompasses at least the band between the relatively short and long wavelengths.
Electromagnetic energy sensor 1000 preferably includes a superficies 1000a that confronts the outer layer s. Preferably, superficies 1000a is generally smooth and includes emitter and detector faces 1002a and 1004a. As the terminology is used herein, “smooth” preferably refers to being substantially free from perceptible projections or indentations.
Electromagnetic energy sensor 1000 preferably is positioned in close proximity to the outer layer s. As the terminology is used herein, “close proximity” of electromagnetic energy sensor 1000 with respect to the outer layer s preferably refers to a relative arrangement that minimizes gaps between superficies 1000a and the outer layer s. Preferably, electromagnetic energy sensor 1000 contiguously engages the outer layer s as shown in
The inventors discovered a problem regarding accurately identifying the occurrence of structural changes in the volume of interest p because of a relatively low signal-to-noise ratio of detected electromagnetic radiation 1004b. In particular, the inventors discovered a problem regarding a relatively large amount of noise in detected electromagnetic radiation 1004b that obscures signals indicative of unintended fluid accumulation. Another discovery by the inventors is that the amount of noise in detected electromagnetic radiation 1004b tends to correspond with the degree of body activity. In particular, the inventors discovered that detected electromagnetic radiation 1004b tends to have a relatively lower signal-to-noise ratio when the body is active and that detected electromagnetic radiation 1004b tends to have a relatively higher signal-to-noise ratio when the body is idle.
The inventors also discovered that a source of the problem is an imperfect cavity that may unavoidably and/or intermittently occur between superficies 1000a and the outer layer s. As the terminology is used herein, “imperfect cavity” preferably refers to a generally confined space that at least partially reflects electromagnetic radiation. Changes in the shape and/or volume of an imperfect cavity may be unavoidable and/or intermittently occur, e.g., when there is relative movement between superficies 1000a and the outer layer s. In particular, the inventors discovered that the source of the problem is an imperfect cavity reflecting portions of emitted electromagnetic radiation 1002b and/or detected electromagnetic radiation 1004b that are detected by electromagnetic radiation signal receiver 1004. Accordingly, detected electromagnetic radiation 1004b includes external electromagnetic radiation in addition to internal electromagnetic radiation. As the terminology is used herein, “external electromagnetic radiation” preferably refers to portions of emitted electromagnetic radiation 1002b that are reflected in an imperfect cavity at an interface of superficies 1000a and the outer layer s, and “internal electromagnetic radiation” preferably refers to portions of emitted electromagnetic radiation 1002b that penetrate through the outer layer s and are reflected, scattered or otherwise redirected from the volume of interest p. Preferably, internal electromagnetic radiation includes a signal that indicates the occurrence of structural changes in the volume of interest p whereas external electromagnetic radiation predominately includes noise that tends to obscure the signal. Thus, the inventors discovered, inter alia, that an imperfect cavity defined by superficies 1000a and the outer layer s affects the signal-to-noise ratio of detected electromagnetic radiation 1004b.
Absorber 1130 preferably absorbs electromagnetic radiation that impinges on surface 1118. As the terminology is used herein, “absorb” or “absorption” preferably refer to transforming electromagnetic radiation to another form of energy, such as heat, while propagating in a material. Preferably, absorber 1130 absorbs wavelengths of electromagnetic radiation that generally correspond to the wavelengths of emitted and detected electromagnetic radiations 1002b and 1004b. According to one embodiment, absorber 1130 preferably absorbs electromagnetic radiation in the near-infrared portion of the electromagnetic spectrum. Absorber 1130 may additionally or alternatively absorb wavelengths in other parts of the electromagnetic radiation spectrum, e.g., visible light, short-wavelength infrared, mid-wavelength infrared, long-wavelength infrared, or far infrared. Absorber 1130 preferably absorbs at least 50% to 90% or more of the electromagnetic radiation that impinges on surface 1118. Preferably, less than 2 milliwatts of electromagnetic radiation impinge on surface 1118 at any given time.
Absorber 1130 preferably includes a variety of form factors for inclusion with housing 1110. Preferably, absorber 1130 includes at least one of a film, a powder, a pigment, a dye, or ink. Film or ink preferably are applied on surface 1118, and powder, pigment or dye preferably are incorporated, e.g., dispersed, in the composition of housing 1110.
Absorber 1130 preferably improves the signal-to-noise ratio of detected electromagnetic radiation 1004b by reducing noise 1004b2. Compared to electromagnetic energy sensor 1000 (
Electromagnetic energy sensor 1100 preferably may be used, for example, (i) as an aid in detecting unintended fluid accumulation; (ii) to identify a structural change in the volume of interest p; or (iii) to analyze an internal electromagnetic signal. Preferably, electromagnetic radiation signal transmitter 1002 transmits emitted electromagnetic radiation 1002b via emitter face 1002a. Emitted electromagnetic radiation 1002b preferably propagates through foundation 1010 and/or cavity C, if either of these is disposed in the path of emitted electromagnetic radiation 1002b toward the target area of the outer layer s. According to one embodiment, emitted electromagnetic radiation 1002b divides into internal portion 1002b1 and external portion 1002b2.
Internal portion 1002b1 of emitted electromagnetic radiation 1002b preferably propagates through the outer layer s toward the volume of interest p. Preferably, at least a first portion of internal portion 1002b1 is at least one of reflected, scattered or otherwise redirected from the volume of interest p toward the target area of the outer layer s as signal 1004b1. After propagating through the target area of the outer layer s, signal 1004b1 preferably further propagates through the cavity C and foundation 1010, if either of these is disposed in the path of signal 1004b1 toward electromagnetic radiation signal receiver 1004. Preferably, electromagnetic radiation signal receiver 1004 receives signal 1004b1 via detector face 1004a. Signal 1004b1 preferably includes an internal electromagnetic signal that may be analyzed to, for example, identify structural changes in the volume of interest p and/or as an aid in detecting unintended fluid accumulation.
External portion 1002b2 of emitted electromagnetic radiation 1002b is reflected in cavity C, but preferably is generally absorbed by absorber 1130. Preferably, absorber 1130 absorbs at least 50% to 90% or more of external portion 1002b2 that impinges on surface 1118. Accordingly, a portion of noise 1004b2 due to external portion 1002b2 preferably is substantially eliminated or at least reduced by absorber 1130.
Absorber 1130 preferably also absorbs another portion of noise 1004b2 due to electromagnetic radiation other than external portion 1002b2 in cavity C. For example, absorber 1130 preferably also absorbs a portion of signal 1004b1 that impinges on surface 1118 rather than being received by electromagnetic radiation signal receiver 1004 via detector face 1004a.
According to a preferred embodiment of the invention, the sources of signal 1004b1 and noise 1004b2 include three portions of emitted electromagnetic radiation 1002b. Preferably, a first portion of emitted electromagnetic radiation 1002b is at least one of reflected, scattered or otherwise redirected from the volume of interest p through the target area of the outer layer s to detector face 1004a. This first portion of emitted electromagnetic radiation 1002b preferably is the source of signal 1004b1. Preferably, a second portion of emitted electromagnetic radiation 1002b is at least one of reflected, scattered or otherwise redirected from the volume of interest p and impinges on surface 1118 of superficies 1102. This second portion of emitted electromagnetic radiation 1002b preferably is the source of a first portion of noise 1004b2 that is absorbed by absorber 1130. Thus, internal portion 1002b1 of emitted electromagnetic radiation 1002b preferably is the source of signal 1004b1 and may also be the source of some noise 1004b2. Preferably, a third portion of emitted electromagnetic radiation 1002b, e.g., the external portion 1002b2, is reflected in cavity C but is absorbed by absorber 1130 when it impinges on surface 1118 of superficies 1102. This third portion of emitted electromagnetic radiation 1002b preferably is the source of a second portion of noise 1004b2 that is absorbed by absorber 1130. Accordingly, absorber 1130 at least partially absorbs noise 1004b2 due to one or more sources including external portion 1002b2 (e.g., the third portion of emitted electromagnetic radiation 1002b) and internal portion 1002b1 (e.g., the second portion of emitted electromagnetic radiation 1002b).
Thus, absorber 1130 preferably improves the signal-to-noise ratio of detected electromagnetic radiation 1004b by absorbing noise 1004b2. Preferably, reducing noise 1004b2 in detected electromagnetic radiation 1004b makes it easier to analyze signal 1004b1 in detected electromagnetic radiation 1004b.
Changes in the size and/or volume of cavity C preferably may also be used to monitor body activity and/or verify sensor inspections by a technician. Preferably, information regarding the frequency and degree of body activity may be detected by electromagnetic energy sensor 1100. Accordingly, this information may aid a technician in evaluating if excessive activity is increasing the risk of disrupting a fluid flow in the body. Similarly, electromagnetic energy sensor 1100 preferably may be used to detect technician inspections of the target area of the outer layer s. Preferably, a technician periodically inspects the body for indications of unintended fluid accumulation. These inspections preferably include touching the target area of the outer layer s; which tends to cause relative movement between electromagnetic energy sensor 1100 and the outer layer s. Accordingly, a record of detected electromagnetic radiation 1004b preferably includes the occurrences over time of technician inspections.
While the present invention has been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.
This application is a continuation-in-part of U.S. patent application Ser. No. 13/792,072, filed 10 Mar. 2013, which claims the priority of U.S. Provisional Application No. 61/706,726, filed 27 Sep. 2012, and also claims the priority of U.S. Provisional Application No. 61/609,865, filed 12 Mar. 2012, all of which are hereby incorporated by reference in their entirety.
Number | Date | Country | |
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61706726 | Sep 2012 | US | |
61609865 | Mar 2012 | US |
Number | Date | Country | |
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Parent | 13792072 | Mar 2013 | US |
Child | 14314471 | US |