Patent Application
20150105652
The present invention generally relates to the field of neonates immobilizing by a restrainer comprising a navel's infusion aperture. The invention also pertains to methods of immobilizing neonates by his restrainer whilst neonate's navel is continuously accessible for both visual inspection and medical treatment.
Central catheter is a thin, flexible tube or catheter placed in a larger vein or artery to deliver medications or necessary fluids to your baby. Central catheters also include umbilical venous and umbilical artery catheters which may be inserted into the vein or artery of the umbilical cord (belly button). Newborns that need special care, especially those hospitalized in neonatal intensive care unit (NICU), are frequently coupled and intubated to life sustaining and monitoring lines at all times, including during their MRI scanning, where their immobilization is required.
U.S. Pat. No. 6,992,486 discloses a magnetic resonance imaging system and a life sustaining incubator system used for neonates. The system includes restraining mechanisms for supporting, and immobilizing the infant and during MRI examination. U.S. Pat. No. 6,860,272 further discloses a device for diagnostic procedures when using an MRI unit, CT scan unit or x-ray unit, which comprises a patient resting surface to which a patient's body parts are firmly, but comfortably secured. The device further includes anchoring means for immobilizing the patient by applying a controllable pressure upon the patient's skeleton, joints and spine. The above described systems, however, do not provide a complete solution for immobilizing newborn whilst providing micro-environment surrounding in a secured manner, during MRI scanning, namely providing the infant a continuous life sustaining and monitoring lines. Hence, prior art does not disclose neonate's restraining means where neonate's belly button is continuously accessible for both visual inspection and medical treatment.
Kitterman et al., in Catheterization of umbilical vessels in newborn infants (1970) Pediatric Clinics of North America 17(4) 895-91, which is incorporated herein as a reference, concluded that the use of an indwelling catheter in an umbilical vessel can lead to improved care of sick infants; however, it may also lead to serious complications, such as thrombosis, embolism, vasospasm, vascular perforation, vascular damage from hypertonic solutions, hemorrhage, bowel perforation following exchange transfusion, infection, electrical hazards etc.
Regarding infection hemorrhage risks related with this catheterization an umbilical arterial catheter is a direct connection to the aorta, and thus there is a constant risk of major and even fatal hemorrhage (see Kitterman et al.). It is extremely important to notice immediately if it becomes disconnected. This requires close nursing supervision at all times. Ideally, each infant with an indwelling umbilical arterial catheter should have a nurse assigned to care for him alone. Because the infant may pull or kick the catheter or its connecting tubing, the infant's arms and legs must be restrained. If significant bleeding occurs, the infant's blood volume should be restored as soon as possible by transfusion. Regarding infection risks related with this catheterization, the umbilical dressing should be changed and an antibiotic ointment applied daily; catheters should be removed from umbilical vessels as soon as they are no longer essential for the infant's welfare. In addition, care should be taken not to contaminate the catheter connections or syringes used for withdrawing or injecting blood or other fluids through the catheter.
Therefore, there is a long felt and unmet need to provide an MRI-proof neonates immobilizing arrangement whereby neonate is effectively restrained whilst his/her navel is continuously accessible for both visual inspection and medical treatment.
It is thus an object of the present invention to provide a neonate's immobilizing arrangement whereby the neonate is effectively restrained whilst his/her navel is continuously accessible for both visual inspection and medical treatment.
It is another object of the present invention to provide neonate's immobilizer as defined above, wherein this immobilizer comprises a lower torso segment having dorsal side and ventral side, an upper torso segment having the same, and a median navel segment in between, having a lateral side. The three segments are interconnected to form a continuous restraining shell along said dorsal side. The navel segment has a lateral side, wherein the navel segment's lateral side, lower and upper segments form an access aperture around the navel when restraining the neonate, the aperture is provided in size and shape for visual inspection and physical access to the neonate's navel.
It is another object of the present invention to provide MRI-proof neonate's immobilizer as defined above, wherein the immobilizer is made of nonmagnetic materials.
It is another object of the present invention to provide MRI-proof neonate's immobilizer as defined above, wherein the immobilizer additionally comprising at least one neonate's head restraining segment, e.g., a single head restraining member interconnected to the aforementioned three segments.
It is another object of the present invention to provide MRI-proof neonate's immobilizer as defined above, wherein the immobilizer is provided with an access aperture which allows intubation of an infusion system via the neonate navel during medical care and analysis, e.g., along MRI scanning.
It is another object of the present invention to provide a neonate's immobilizer as defined in any of the above, wherein the immobilizer additionally comprises a protective element configured to at least partially and reversibly cover said access aperture.
It is another object of the present invention to provide a neonate's immobilizer as defined in any of the above, wherein the immobilizer additionally comprises at least one radiofrequency (RF) coil aligned with the neonate's head.
It is another object of the present invention to provide a neonate's incubator comprising a neonate immobilizer as defined in of the above.
It is another object of the present invention to provide a method for restraining a neonate characterized by steps of providing a neonate's immobilizer with a lower torso segment having dorsal side and ventral side, an upper torso segment having the same, and a median navel segment in between, having a lateral side; interconnecting said three segments are form a continuous restraining shell along said dorsal side; providing said navel segment with a lateral side ; forming, by means of said navel segment's lateral side, lower and upper segments an access aperture around said navel, thereby when restraining said neonate, providing said aperture's size and shape for visual inspection and physical access to said neonate's navel.
It is another object of the present invention to provide a method as defined above, the method additionally comprises a step of constructing the immobilizer by MRI-proof materials.
It is another object of the present invention to provide a method as defined above, the method additionally comprises a step of providing the immobilizer with a neonate's head restraining segment.
In order to understand the invention and to see how it may be implemented in practice, a few preferred embodiments will now be described, by way of non-limiting example only, with reference to be accompanying drawings, in which:
The following description is provided so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide means and methods for neonates immobilizing by a restrainer comprising a navel's infusion aperture
The terms ‘magnetic resonance device’ and MRD interchangeably applies to any medical device and analysis device, such as a magnetic resonance imaging (MRI) device, nuclear magnetic resonance (NMR) spectroscope, electron spin resonance (ESR) spectroscope, nuclear quadruple resonance (NQR) computerized tomography (CT), ultrasound (US) and any combination thereof. As used herein, the term “neonate” refers to any of the following: neonate, baby, infant, premature baby, child, newborn, human patient, and other mammalians (e.g., laboratory animals).
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It is in the scope of the invention wherein the central catheter and/or infusion system is selected in a non-limiting manner from a group consisting, inter alia, infusion tube system, life support system, air and oxygen tubes, respirator tubes, intravenous tubes, ventilation tubes, catheter and any combination thereof. It is further in the scope of the invention wherein the access aperture (7b) allows coupling the central catheter and/or infusion system via neonate's navel for supplying the neonate element(s) selected in a non-limiting manner from a group consisting of fluids (e.g., blood, isotonic solutions), gasses (e.g., oxygen), medications and any combination thereof. It is further in the scope of the invention wherein access aperture (7b) allows connection to at least one physiological sensor to be connected or otherwise introduce to neonate's body.
It is further in the scope of the invention wherein immobilizer (1) is at least partially made from materials selected from the group consisting, inter alia, semi-flexible materials, semi rigid materials, rigid materials, flexible materials and any combination thereof.
In another embodiment of the present invention, immobilizer (1) comprises or otherwise provide in connection with at least one radiofrequency (RF) coil aligned with the neonate's head, bally or other predefined organ or location. Such a coil, according to yet another embodiment of eth invention, is integrated with immobilizer (1) or a segment thereof, appended to at least one portion of the immobilizer, provided in connection with immobilizer (1) or any combination thereof.
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In another embodiment, the shell and the support tray may be integrated as one unit for stabilizing and in parallel immobilizing the neonate body to the incubator.
The present invention further provides an MRD immobilizer device (e.g., immobilizer 1) adapted for immobilizing a neonate during MRI scan.
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In another embodiment of the present invention, intravenous (IV) lines and monitoring cables are grouped at the feet end of the immobilizer. Vital signs (e.g., ECG and pulse oximetry) are monitored with this in vivo simultaneously medically treating and immobilizing system.
