Patent Application
20130310771
1. Field of the Invention
The subject invention is directed to the field of medical devices, and more particularly to devices for use in protecting patient-connected structures such as tubes and wires, including but not limited to IV tube sets, catheters and sensor wires.
2. Description of Related Art
Various patient-connected structures find use in medical facilities, in operating rooms, patient rooms, and the like. Such structures include, for example, intravenous (I.V.) infusion sets, electrical leads for electrocardiogram (EKG), electroencephalogram (EEG), oxygen sensors, wound drains, suction tubing, urinary catheter tubing, feeding tubes and still other structures.
While placement of such structures is necessary to treat injuries or symptoms, to alleviate pain and discomfort that a patient is enduring and, in many cases, keep the patient alive, such structures and the connections thereof are susceptible to tampering and damage, particularly in cases of uncooperative patients, and more particularly in cases of mentally-ill patients.
Applicant recognizes that it would be advantageous to provide devices in a clinical setting that could be employed to protect the aforementioned structures from tampering, damage and improper removal, thereby protecting the patient's wellbeing to the extent possible.
In accordance with one aspect of the present invention, a medical conduit protection device is provided having an elongate body having a wall, defining a lumen therein, and having first and second opposed ends, the body being adapted and configured to receive, within the lumen thereof, one or more elongate medical conduits. The device also includes a first tether provided on the first end of the body, the first tether being adapted and configured to secure the first end of the body to a patient-end anchor point (such as a patient or a location relatively near to a patient, such as a bed rail) and a second tether provided on the second end of the body, the second tether being adapted and configured to secure the second end of the body to an external anchor point. The medical conduit protection device inhibits tampering with or damage to the one or more medical conduits within the lumen of the body by transferring externally-applied strain away from the one or more medical conduits within the lumen thereof.
The body can be a substantially continuous tubular structure, adapted and configured to receive one or more medical conduits therethrough, from the first end to the second end thereof. The body can be formed from a resilient material which is resistant to plastic deformation. Alternatively, the body can be formed from a nonwoven fabric. The body can be provided in any needed dimensions practicable, such as with a diameter of between about 2.0 centimeters and about 5.0 centimeters, for example.
In accordance with a further aspect of the invention, the subject medical conduit protection devices can include one or more closure elements adapted and configured for inhibiting access to the one or more medical conduits within the lumen thereof.
In accordance with the invention, the subject medical conduit protection devices can include at least one closure element provided in connection with the body, for inhibiting access to the lumen thereof. The at least one closure element can be a reversibly attached closure element. Further, the at least one closure element can be adapted and configured to require a separate tool for removal thereof. The at least one closure element can be a one-way closure element. The at least one closure element can be a concentrically rotatable tubular element arranged over the body.
In accordance with a further aspect of the invention, the body can include at least one inflatable element, the at least one inflatable element being adapted and configured to impart structural rigidity to at least a portion of the body.
Additionally or alternatively, the body can include at least one semi-rigid element, the at least one semi rigid element being adapted and configured to impart structural rigidity to at least a portion of the body. The at least one semi-rigid element can be a helical spine provided in connection with the wall of the body.
In accordance with the invention, the subject medical conduit protection devices can include an alarm adapted and configured to sound when detecting tampering with the medical conduit protection device.
In accordance with the invention, the subject medical conduit protection devices can additionally or alternatively include a safety release feature, adapted and configured to release when a force exceeding a predetermined value is applied to the medical conduit protection device. An alarm can be provided in connection with the safety release feature, adapted and configured such that when the force exceeding the predetermined value is applied to the medical conduit protection device, the alarm is sounded.
The safety release features can include, but are not limited to one or more lines of weakness, severable connection, releasable connection and/or elastic elements.
In accordance with a further aspect of the invention, a method of protecting medical conduits from damage or tampering is provided, including the steps of providing a medical conduit protection device, the medical conduit protection device being adapted and configured for attachment at a first end to a patient-end anchor point and at a second end to an external anchor point apart from the patient, arranging the medical conduit protection device about one or more medical conduits so as to inhibit access to the one or more medical conduits, and to distribute externally-applied forces away from the one or more medical conduits, securing the first end of the protection device to the patient-end anchor point, securing the second end of the protection device to an anchor point apart from the patient, and connecting the one or more medical conduits at the first end to the patient or a location near the patient and at the second end to medical equipment.
In accordance with still a further aspect of the invention, a medical conduit protection device is provided, having an elongate body having a wall, defining a lumen therein, and having first and second opposed ends, the body being adapted and configured to receive, within the lumen thereof, one or more elongate medical conduits, the first end of the body being adapted and configured to be secured directly to a patient-end anchor point, the medical conduit protection device inhibiting tampering with or damage to the one or more medical conduits within the lumen of the body by shielding from damage the one or more medical conduits within the lumen thereof.
So that those skilled in the art to which the subject invention appertains will readily understand how to make and use the medical conduit protection devices, systems and related methods of the subject invention without undue experimentation, exemplary embodiments thereof are described in detail below along with the related methods, with reference to the drawings, wherein:
The present invention relates to a medical tubing and wire (in general, “medical conduits”) protection devices, and the related systems and methods. As used herein, the term “medical conduits” can include, but should not be construed as being limited to intravenous tubing, other tubing such as drains and catheters, wires or other patient-connected structures. Moreover, Applicant specifically conceives that the subject devices can advantageously be applied to protect structures or devices which may not necessarily be “conduits.” Nevertheless, the term “medical conduit(s)” is used herein for simplicity.
In a clinical setting, patients who are unable or unwilling to cooperate and adhere to recommendations regarding limiting movement and not disrupting medical tubes or wires are often encountered. Such patients, for example, may include pediatric, demented, delirious, psychiatric or otherwise uncooperative patients. In such patients, maintaining the patency of the various medical tubes and wires may prove difficult as such patients often attempt to tamper with or remove IV-lines, catheters or sensors. Such behavior, naturally, can jeopardize such patients' wellness.
The subject medical conduit protection devices, example embodiments of which are discussed herein and illustrated in the appended figures, are configured to protect patient-attached medical conduits. It should be noted, however, that devices in keeping with the invention could be applied in still other situations, in which protection of structures is desired, which are not necessarily attached to, near, or for the benefit of a patient. Moreover, the subject devices may advantageously find use in a veterinary setting. In patients who might be expected to present the aforementioned difficulties or already have proven difficult, the device can be placed around vulnerable tubes and wires and the each end secured in such a way that forces, which would otherwise be placed on these tubes and wires (conduits), would be transferred to the protection device instead. So, for example, one end of the device can be attached to a patient's limb, with the IV catheter inserted in it, and with the other end of the device secured to an IV pole, for example. Such an arrangement advantageously allows the IV line to pass as it normally would, with its function unaffected, while any movement of the limb that would otherwise tension the conduits and risk violation thereof is be transferred to the protection device instead. Furthermore, depending on the precise implementation, the area of the conduits that would be vulnerable to kinking, bending, cutting, or biting by the patient would be covered by the protective surface of the device and thus protected.
Devices in accordance with the invention, in general, support medical conduits and protect such conduits from tampering and damage. In one aspect, devices in accordance with the invention substantially or completely surround one or more medical conduits, and thus prevent damage to these tubes from longitudinal or transverse pulling, intentional kinking, assaults with hands or sharp objects, or biting, for example. Advantageously, in collecting a plurality of medical conduits within one device can also serve to enhance safety in a clinical environment my reducing the usual array of patient-attached structures to a single device when practicable, simplifying the environment surrounding the patient, thereby reducing the tripping and/or entanglement hazard that multiple individual conduits often create.
In accordance with one aspect of the invention, it is preferred that a body of the subject devices be formed from a material that resists cutting, kinking, biting, and other physical assaults. Depending on the implementation, the body of the subject devices can be relatively close to that of the contained conduits, closely bundling such conduits. In such embodiments, as well as in other embodiments described herein, a longitudinal opening (e.g. slit) can be provided to permit transverse insertion of medical conduits. Such an arrangement is advantageous in that the conduits can be gathered and collected within subject protection devices while the conduits are already attached to the patient, while additional conduits can be easily added to the others at a later time. Alternatively, the body of the subject devices can be dimensioned to be substantially larger than that of the contained conduits, which can facilitate insertion of the medical conduits from an end, along the length of the body, if desired. Such an arrangement advantageously reduces potential for tampering, as there are no closures that would be susceptible to damage.
In accordance with the invention, the subject devices can be provided in any practicable dimensions. However, it is believed that protection devices having an inner diameter, that is, of a lumen running the length of the protection devices, of between about 2.0 and 5.0 centimeters. and a length of between about 0.5 and 2.0 meters. The length of the subject protection devices, in general, should be sufficient to at least protect a vulnerable length of the medical conduits, typically a section of such conduits nearest the patient, and need not necessarily extend a majority of the length of the medical conduits.
Further, as will be appreciated by the reader, the subject devices, depending on their precise configuration, can be deployed in any of a variety of lengths, for example in embodiments that are provided with a relatively soft wall, the wall can be gathered at one or both ends thereof, thus reducing the overall effective length of such devices, as needed.
The subject protection devices are preferably further provided with connections or tethers at each end thereof for securing the protection devices in a stable and safe manner. For example, a patient-end tether can be configured as a soft cuff, for the safety and comfort of the patient, while a tether at a far end can be a simple tie, such as a lace or a cord for example.
The body and tethers of the subject protection devices are preferably provided with sufficient strength so as to be able to effectively resist tension due to longitudinal pulling or transverse application of force. In accordance with a further aspect of the invention, however, the subject devices can be provided with one or more safety features that yield at a predetermined level of force, releasing the device at an end or along the body thereof. In such implementations, incorporation of an alarm feature, which would sound in case of application of excessive force, can be included.
The subject protection devices can be configured such that a natural or relaxed state of the material from which it is made automatically surrounds the medical conduits to be protected. For example if the body is formed from a resilient tubular material having a single lengthwise slit formed therein, the body can be deformed to reveal the lumen and permit lateral insertion of medical conduits, the material then relaxing into a closed configuration around the conduits once the deforming force is removed. Alternatively or additionally, one or more closure elements can be provided in connection with the body of the subject devices. Such closure elements can be of any suitable configuration, including but not limited to lace ties, straps, belts-and-buckles, hook-and-loop fasteners, adhesive tape, one or more zippers such as a lengthwise zipper, for example, an interlocking dovetail, a continuous press-to-seal closure (akin to those applied to some plastic sandwich bags), interlocking teeth or otherwise mechanically interlocking features and so on. Such features, it should be noted, can be provided at discrete positions along a length of the devices, and/or as a continuous closure along the length of the devices.
Turning now to the drawings, there is illustrated in
The one or more closure elements 140 are disposed along the body 110 thereof, which body 110 includes a longitudinal slit 115 that permits access to the lumen 180 defined therein. As best illustrated in the cross-sectional view of
As illustrated, the medical conduit protection device 300 does not include a longitudinal opening, but only first and second and openings to access the lumen 380. However, it is to be understood that a longitudinal closure can be applied in conjunction with features described in connection with this embodiment.
Similarly,
If so desired, the closure elements 1240 can be formed from something as simple as the metallized sheet connected to the body 1210 by way of conductive elements which can be, if desired, one-way connectors that do not permit removal without destruction of at least a portion thereof, thus enhancing tamper resistance and tamper evidence of the subject devices.
Unlike the foregoing embodiments, neither a first tether nor a second tether are provided. Instead, a patient end of the protection device 1400 may be attached directly to the patient as needed, such as by medical tape or other dressing. Further, a far end can simply be draped over the conduits to be protected, and remain in place, either by the inherent structural properties of the device, by friction, by application of a separate tie or restraint, or other force, depending on the precise implementation. Further, it is to be understood that only one of the end tethers can be eliminated, if desired. In such embodiments, the subject protection devices will not distribute applied external forces as fully as with the foregoing embodiments, but tampering with or damage to the attached conduits, and other advantages, can still be achieved.
Furthermore, as illustrated, although optional, a portion 1521b of the cuff 1521 is made from a transparent material to permit monitoring of an insertion site of patient-connected medical conduits. As such, a healthcare professional is able to more easily monitor the insertion site for any movement of conduits, bleeding, infection or infiltration of any medicament into surrounding tissues.
As illustrated, ties 1523a, 1523b are optionally provided on the non-transparent part 1521a of the cuff 1521 so as to facilitate attachment to the patient. However, other securing features can be provided in place of or in addition to such ties 1523a, 1523b.
In accordance with the invention many from materials can be utilized in the manufacture of the subject devices. Materials can include but are not limited to woven fabrics, nonwoven fabrics, plastics, metallized plastics, elastomers, laminated sheets, composite sheets, rigid tubes, semi-rigid tubes and others. The subject devices can be fabricated by way of any suitable technique including, but not limited to, heat welding, solvent welding, stitching, adhesives, staples and the like.
If so desired, magnetic elements can be provided for closure of the body openings and/or for connection of the subject devices to external points such as an IV pole. Further, if desired, one or more strain gauges can be applied to the bodies of the subject devices or to the tethers, for example. Additionally or alternatively, if desired, the subject devices can be provided with further features for safety including, but not limited to, an integrated panic button electrically connected to the alarm and/or a releasable ripcord to quickly open up the subject devices, should a problem arise needing rapid attention, for example.
The alarm features of the subject devices can include more sophisticated detection circuitry than simply requiring completion of a series circuit to maintain an alarm in the off state. Such circuits can include measurement of minute changes in resistance, changes in capacitance of various elements that may be provided on such devices, and/or monitoring the status of one or more strain gauges integral to the subject devices, for example. Further, location information based on detection of proximity sensors in a hospital room, on the floor of a ward, or elsewhere in a building can be incorporated, for example, to permit higher variance of detected impedance when walking or otherwise moving. Conversely, if the patient is in bed, the alarm circuitry can be configured so as to have reduced tolerance of detected disturbances (such as a duration and/or magnitude of changes in parameters such as capacitance or resistance). In this way, it may be possible to accurately differentiate between a patient who is simply moving around to go to the bathroom and a patient who is actively tampering with the subject devices.
Further, if an alarm feature is provided in connection with devices in accordance with the invention that have one or more inflatable portions, one or more pressure gauges can be utilized to detect a fluctuation or larger changes in pressure—higher or lower than an initial pressure—in the chambers of such devices which may indicate tampering.
While the devices and related methods of subject invention have been shown and described with reference to selected embodiments, those skilled in the art will readily appreciate that changes and/or modifications may be made thereto without departing from the spirit and scope of the subject invention. Moreover, it should be understood that elements or features described in connection with any embodiment disclosed herein can be advantageously applied to other embodiments described herein, if practicable and not mutually exclusive with other features of such embodiments.
This patent application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61/647,388, filed May 15, 2012, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61647388 | May 2012 | US |
