This present invention relates to and, more particularly, to a medical assistive device holder to secure life support and life sustaining lines and devices. This present invention can be used with one or more Mom's Second Skin Swaddles, the Kango Wrap, the Mama Swaddle and the Cami Carrier, all designed to hold an infant in, or out of, Skin-to-Skin Contact. This present invention can be used for hands-free breast pumping, single or multiple births, premature, low birth weight or full term medically compromised infants and is not restricted for “infant only” applications. This present invention can also be used with the Comfort Band Tie or other securement garment/s to position and secure all life support lines. This present invention is freely adjustable regardless of body shape or size and has application with regard to large and small animal use. However, modifications and variations to those skilled in the art allow for alterations and variations to occur without departing from the original scope and use.
Other embodiments of this invention will be apparent to those skilled in the art from the consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only and that modifications may be made to the described embodiments without departing from the spirit and scope of the invention as defined in the Claims.
Research has shown multiple benefits of holding an infant, especially in Skin-to-Skin Contact, for both the newborn and mother. However, accomplishing this can be complicated in infants with special needs requiring life support and life sustaining measures. Medical staffs have reported two important concerns with infants being held, especially in Skin-to-Skin Contact, 1) there was no garment or assistive medical apparatus that could securely hold and position life support or life-sustaining lines and devices in place without threat of displacing them or extubation and, 2) pathogen cross-contamination of medical lines in Skin-to-Skin Contact. Since there exists a strong potential for an unexpected crisis to develop in the hospitalized medically compromised infant, the need for a securement garment/apparatus for medical lines, tubing and devices that can be rapidly released from the wearer (adult holding the infant in Skin to Skin Contact) to transfer with the infant for emergency intervention without the threat of dislodging life support/life-sustaining lines and medical devices was urgent.
This present invention serves to secure and stabilize life support lines, in the medically fragile/compromised infant with extended uses applicable to medical assistive devices employed to monitor body function/s, administer medications, IV fluids, O2 and/or provide diagnostic evaluation of a patient when assistive medical devices are necessary to establish and maintain homeostasis. Specifically, this invention accommodates medical devices commonly used in the critical or compromised infant to include but not limited to various central lines, gastronomy tubes, Ostomy bags, Endotracheal tubes, a multiplicity of medical monitors and other supportive or life-support devices.
An increasing number of patients are born with critical medical issues requiring the continuous use of assistive medical devices that perform and support vital bodily and life-sustaining functions beyond the hospital setting. The number of medical devices needed to sustain life and assist in proper body function is determined by the diagnosed medical condition; further the ability to secure the necessary medical device/s and various life-support lines in place becomes critical to effective and successful outcomes whether the device/s will be necessary on a temporary or permanent basis.
Unfortunately, the use of, and need for, such assistive medical devices and life-support lines are required most in the premature underdeveloped infant or an infant born with improperly formed or malfunctioning organs/systems. In these infants, normal routes for hydration, nutrition, elimination and/or adequate lung, heart, immune and gastrointestinal system function is compromised requiring medical assistive devices to be employed to sustain life. The need for such devices can be temporary or permanent depending on the body's ability to restore function as the infant matures or successful surgical intervention corrects the problem or permanent if medical/surgical intervention is unsuccessful or a progressive degenerative condition is present.
Common life-sustaining lines such as Gastronomy tubes, central venous catheter, PICC lines (used for long-term intravenous antibiotics, nutrition or medications, and for blood draws), Jackson Pratt lines (a closed-suction medical device commonly used as a post-operative drain collecting bodily fluids from surgical sites), Ostomy (colostomy/ileostomy), various catheters; assorted monitoring devices, such as cardiac, pacemakers (internal or external) and O2 sensors (internal and external) can present increased infection potential if the site/s are not kept clean and secure. Invasive lines can become easily dislodged if they cannot be held securely in place, which can cause additional medical and surgical procedures to correct placement increasing infection potential exponentially. This potential makes the need for a garment/line holder invention necessary to effectively and securely hold all lines and medical devices in place protecting sites into and exiting from an infant's body. This present invention ensures secure hold and also creates an additional safety barrier inhibiting cross contamination from mother's skin to the infants life support/life-sustaining lines, tubing or medical devices significantly decreasing pathogens from coming into contact with entry sites of catheters/medical devices that penetrate the skin of the body. This present invention is easily adaptable to a growing infant accommodating all stages of growth from infancy to adult. This present invention can also be altered adding various pockets to hold monitoring devices securely in place as the infant grows from infancy to adulthood including but not limited to insulin pumps, O2 delivery system and various monitoring or medication administration devices.
The unique design of this present invention is easily transferred with an infant to and from an incubator or bassinet without disturbing life support, life sustaining lines or medical devices in a hospital or home setting. As the infant grows the line holder can be secured in various ways with a multiplicity of attachments to accommodate a changing body shape from infant to toddler, child, pre-teen, teen and adult, providing secure hold and protection while preserving the privacy and dignity of the wearer. The breathable, flexible and water friendly fabric of this present invention allows for adaptability to all stages of growth, body shape, activity levels and sweating without losing its shape or hold and cleans easily drying quickly.
This present invention also has application for acquired disease processes, including traumatic, in the adult population and can be easily altered to accommodate individualistic needs to include pocket additions, attachments and varied body positioning on the wearer to accommodate multiple medical devices, lines, tubing, catheters and monitoring devices with secure hold and privacy.
Thus, the Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices was designed and created. The Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices has met the challenge providing an opportunity for mothers to safely hold their special needs or medically compromised infant(s) in or out of Skin-to-Skin Contact. For Skin-to-Skin Contact, when used in conjunction with one or more Mom's Second Skin Swaddles, the Kango Wrap, the Mama Swaddle, the Cami Carrier, the Comfort Band Tie or other securement garments, the infant(s) and all life support and life sustaining lines and medical devices are safely secured with correct placement maintained. The Medical Assistive Device Holder for Life Support and Life-Sustaining Lines and Devices easily adapts for use in the NICU, a hospital or birthing center setting throughout all phases of life addressing a multitude of medical needs whether in the hospital, home, school, workplace, rehabilitation or geriatric setting. In some applications, when used in childhood to adulthood, the Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices can be secured in place with a multiplicity of closures to include but not limited to anchor, D-ring, slide buckles, slide release buckles, as well as varying closures from the group consisting of hook and loop closures, hook and eye closures, snaps, zippers, magnets, and the like.
This present invention design secures lines tubing and life support life sustaining devices enabling an infant(s) to be held Skin-to-Skin in the neonatal intensive care unit and beyond preventing extubation, the number one problem with pre-term infants being held Skin-to-Skin. The use of this Line Holder greatly reduces that possibility while simultaneously organizing all lines and tubing entering and exiting the medically compromised infant(s) body, which facilitates frequency and duration of safe infant hold by a parent or hospital staff. This present invention works independently and easily adjusts to fit all body shapes, sizes or garment(s) worn allowing a custom fit with secure hold and comfort for extended lengths of time without pathogen contamination of lines or devices by touching the wearer's skin.
With the use of the Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices the benefits of Skin-to-Skin Contact, as established by over 4,000 research studies and articles, can be realized in the most medically compromised of infants.
It was presented at the KMC Acceleration Meeting of Maternal, Newborn and Child Health, the Bill and Melinda Gates Foundation, Save the Children Saving Newborn Lives and others on Oct. 21-22, 2013 in Istanbul, Turkey:
Method and Apparatus to Secure Life Support Lines to an Infant during Neonatal Care—Patent No.: US 20110087171 A1
In accordance with the present invention, there is provided a device that allows for safe and correct positioning of an infant held Skin to Skin providing secure hold of all life support and life sustaining lines and devices traditionally utilized in the medically compromised infant to include but not limited to Central Lines, PICC Lines, Umbilical Catheter/s, Intravenous Lines, Blood Pressure and Cardiopulmonary Monitoring Leads, Pulse Oximeter, Thermomonitoring, Suction Device, C-Pap, Endotracheal Tube, Mechanical Ventilator and other Oxygen Delivery or Invasive Therapy Lines.
The Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices is easily adapted to all body shapes and sizes without restriction, is not limited to a fixed location on the body of a wearer and is applicable in multiple births with the addition of a second Medical Assistive Device Line Holder to the wearer on the opposite side of the body from the sibling.
The Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices can be transferred with an infant should emergency medical intervention be needed without compromising, disturbing or dislodging life support or life sustaining line/s, device/s or catheter/s placement and/or delivery capabilities.
The Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices is held in place by a securement garment where both ends of the Medical Assistive Device Line Holder are tenable. Its secure placement is best achieved with one or more Mom's Second Skin Swaddles, the Kango Wrap, the Mama Swaddle, Cami Carrier, or the Comfort Band. Tie, especially in multiple birth applications, but is not restricted to these securement garments alone. This present invention is applicable for infants classified as premature through large birth weight infants, multiple birth medically compromised infants including conjoined twins.
A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which:
The following detailed description represents the best currently contemplated modes for carrying out the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention.
This Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices is designed to secure lines and tubing on a person when holding an infant in a special care unit with the need for lines, tubing and medical assistive devices and is secured in place with our patent pending Second Skin Swaddle/Mom's Second Skin, the Kango Wrap, Mama Swaddle, Cami Carrier, Comfort Band Tie or other securement garment/s. Multiple Medical Assistive Device Holders for Life Support and Life Sustaining Lines and Devices may be used to secure lines, tubing and medical assistive devices for one or more infants. This present invention is easily adapted for toddler and child through adult applications.
The Medical Assistive Device Holder for Life Support and Life Sustaining Lines and Devices of
The second hook and loop closure is positioned approximately 3-5″ from the shoulder hook and loop closure depending on size of wearer. Hook closure 4 is positioned to be sewn the width of the line holder sash 1. Reinforced loop closure 6 and 7 are sewn in at an angle under projected ends of the hook closure 4 to form an X when spread. Hook closure 4 is sewn in place over angled strips 6 and 7 which measure approximately 8″ in length. Reinforced loop closure 5 is sewn to the end of hook closure 4 to span width of sash 1 plus 1-2″ with finished end tab. The lower hook and loop closure 8 and 9 is positioned approximately 4-6″ below the second hook and loop closure 4, 5, 6 and 7 with hook closure 8 sewn the width of sash body 1. The reinforced loop closure 9 is sewn to the end of hook closure 8 and spans the width of 8 plus 1-2″ with finished end tab. The Mom's Second Skin 10 is positioned at waist to secure line holder when in use.
Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.
Having thus described the invention, what is desired to be protected by Letters of Patent is presented in the subsequently appended claims.
The present application is related to United States patent number US 20110087171 A1, published Apr. 14, 2011, for METHOD AND APPARATUS TO SECURE LIFE SUPPORT LINES TO AN INFANT DURING NEONATAL CARE, by Jennifer Bracci, included by reference herein. The present application is related to United States patent number US 20060206978 A1, published Sep. 21, 2006, for MEDICAL GARMENTS FOR ASSISTING IN SKIN-TO-SKIN HOLDING OF INFANTS IN NEONATAL INTENSIVE CARE UNITS, by Shandin Hilton and Pamela Sprague, included by reference herein. The present application is related to United States patent number US 2015/0119845 A1, publication date, Apr. 30, 2015, for SECURING DEVICE FOR MEDICAL LINES, by Steve A. Collins and Cynthia G. Collins, included by reference herein. The present application is related to U.S. Pat. No. 5,755,225 A, publication date May 26, 1998, for MEDICAL TUBE-RETAINING DEVICE, by Teresa H. Hutson, included by reference herein. The present application is related to United States patent number US 20110108594 A1, issued May 12, 2011, for MEDICAL GARMENT FOR SKIN-TO-SKIN CARE AND METHODS OF USE, by Amanda Marie Davis, included by reference herein. The present application is related to U.S. Pat. No. 7,850,595 B2, published Dec. 14, 2010, for TRANSFERRING AND HOLDING DEVICE FOR HIGH-RISK NEONATAL INTENSIVE CARE UNIT (NICU) PATIENTS, by Robert D. White, included by reference herein. The present application is related to United States patent number US 20150089710 A1, published Apr. 2, 2015, for SKIN-TO-SKIN CARE GARMENT, by Matthew C. Halverstadt, Katie A. Halverstadt and Hudlo, LLC, included by reference herein. The present application is related to United States patent number US D752855 S1, published Apr. 5, 2016, for INFANT CARRIER GARMENT, by Matthew C. Halverstadt, Katie A. Halverstadt and Hudlo, LLC, included by reference herein. The present application is related to U.S. Pat. No. 8,763,562 B2, published Jul. 1, 2014, for WEARABLE MEDICAL TUBING AND CABLING CONTAINMENT HARNESS, by Theresia Trevan Fladl, Thomas Lloyd Bellaire, Ernie Janzen and British Columbia Institute of Technology, included by reference herein. The present application is related to United States patent number U.S. Pat. No. 4,168,544A, issued Sep. 25, 1979, for ARTICLE HOLDING SYSTEM, by Robert A. Kallman, included by reference herein. The present application is related to United States patent number U.S. Pat. No. 4,688,270A, issued Aug. 25, 1987, for GARMENT FOR SHEILDING LINES CONNECTED TO A PATIENT DURING INVASIVE THERAPY, by Patricia J. Denicola, Patricia A. Gorgone and Children's Hospital Medical Center Cinncinnati Ohio 45229 A CORP OF OHIO, Cincinnati Children's Hospital Medical Center, included by reference herein. The present application is related to United States patent number U.S. Pat. No. 5,897,519A, issued Apr. 27, 1999, for INTRAVENOUS SECURING DEVICE AND SECONDARY WOUND DRESSING, by Barry F. Sheshol, Marshall P. Reich, George. Glumac and Tapless. TECHNOLOGIES, Inc, Tapeless Tech Inc, included by reference herein. The present application is related to U.S. Pat. No. 6,460,187 B1, published Oct. 8, 2002, for MEDICAL CLOTHING, by Marilyn R. Siegel, included by reference herein.