Patent Application
20220305215
Successful transition from intrauterine to extrauterine life is dependent upon several significant physiologic changes that occur at birth. In most cases, these changes are successfully completed at delivery without any outside intervention. However, nearly ten percent of the nearly 4 million infants born in the United States annually require some level of assistance to begin breathing at birth. Of these, approximately 1% require extensive resuscitation and about 0.3% develop significant morbidity and mortality due to hypoxic-ischemic brain injury. Mortality in infants with hypoxic-ischemic encephalopathy (HIE) ranges from 6-30%. Significant morbidity, such as cerebral palsy and long-term disabilities, occurs in 20-30% of survivors. The Neonatal Resuscitation Program (NRP) was developed in 1987 to identify infants at risk of significant morbidity and mortality and provide high-quality resuscitation. The NRP program has undergone several revisions for improvement over the years.
NRP has several prescribed steps in resuscitation focusing on airway, breathing, circulation, and medications. Several steps must be managed prior to the medication phase of the NRP pathway including adequate ventilation measures and chest compressions. Specifically, if the heart rate is less than 60 beats per minute despite adequate ventilation and chest compressions, epinephrine is administered via endotracheal tube (ETT) or more optimally the umbilical venous catheter (UVC).
The current standard for neonatal epinephrine delivery requires use of a system designed for adult dosing. In an adult code, the epinephrine carpuject syringe delivery system assembles quickly, and the entire prefilled syringe is used in a single dose per the American Heart Association's prescribed algorithm. However, this adult delivery system requires multiple steps, manipulations, and additional equipment in order to convert into an accurate neonatal dose.
Similarly, dosing and delivery complexities exist in delivering other rescue medications such as naloxone, lidocaine, vasopressin, atropine.
The current method of conversion from an adult dose into a neonatal dose causes significant delays in patient care due to cumbersome assembly and significant opportunity for errors in dosing. This current method requires a portion of the total adult dose to be withdrawn from the adult dosage carpuject syringe for delivery to the neonate. Additional opportunity for error is introduced by the fact that neonatal dosing is weight-based and the provider must first estimate a weight in the delivery room, complete a medication calculation, then withdraw the dose from the adult carpuject syringe.
As an example, the current preparation of epinephrine requires several pieces of equipment to be assembled to administer emergency dosing in a neonatal resuscitation. Currently, there is not an available prepared kit on the market that contains all required equipment. The required equipment is instead typically pieced together by the neonatal care team and available in a crash cart.
The American Academy of Pediatrics Neonatal Resuscitation Program suggests that epinephrine should be prepared in 10 seconds during a neonatal code. However, in practice, it can commonly take an otherwise skilled person several minutes to calculate a dose, assemble the equipment, prepare a syringe and have prescribed dose ready to administer to the patient. When considering stopping resuscitation efforts of a newborn around 10-15 minutes from birth, this is too long to wait for emergency administration of a lifesaving drug. It is unacceptable to have to wait for a dose of epinephrine during a code given the known immediate mortality and long-term morbidity outcomes.
Further complicating the matter, there is a difference in provider ability and comfort level in a neonatal resuscitation depending on the medical center in which a neonatal resuscitation occurs. For example, a center that handles thousands of deliveries a year with a high functioning NICU with an experienced code team with specialized providers will be much more prepared to rapidly prepare and calculate an accurate neonatal epinephrine dose. This is a different scenario in a smaller community hospital that may only have a few hundred deliveries a year of relatively healthy infants and rarely sees neonatal codes. There is even less resuscitation experience for deliveries that occur at a birthing center or in the community by emergency personnel. Additionally, the epinephrine dose may be prepared by a variety of providers (RN, ARNP, PA, MD, specialized neonatal pharmacist, hospital pharmacist, midwife, anesthesiologist, paramedic/EMT) all with varying levels of experience, skill, and competence. These factors contribute to the ability to accurately and quickly manipulate the current adult medication equipment to withdraw a potentially lifesaving medication.
Neonates are not born with a known weight or intravenous access in place. The delivery room weight is based on an estimate and the first available access for emergency medication is typically the airway. The estimated weight is based on provider experience, gestational age averages and estimated intrauterine fetal weight. These features present unique challenges to administering emergency medications accurately and efficiently to a neonate.
In a neonatal delivery room code, the first round(s) of epinephrine are given via the ETT. If the response is inadequate, then a UVC is emergently placed for IV dosing. The dosing between these two delivery modes have drastically different dosing up to 10-fold.
In current practice, the same epinephrine vial (1:10,000) is used to draw up the dose for both ETT and intravenous/intraosseous (IV/IO) dosing. Accurate dosing depends on the provider who is preparing the dose to know the different ETT and IV/IO dosing and/or use a dosing chart. The available dosing charts have multiple categories and are challenging to find the correct weight and then correlate to either ETT or IV/IO dosing.
Accordingly, there is presently a need for a kit suitable to quickly and accurately provide doses of resuscitating medications, particularly for neonates.
Toward this end, the present disclosure provides kits for resuscitating a subject, particularly a neonatal patient, to address these challenges detailed in the background, and related issues. In particular, the present disclosure provides kits that address multiple problems in existing neonatal resuscitation procedures including but not limited to: reducing or eliminating the need for equipment assembly (such as stop cock connectors) to allow for emergency medication delivery; eliminating potentially erroneous drug dosing calculations; facilitating direct endotracheal tube (ETT) administration, which is often first route of administration and reduces likelihood of mistaken intravenous/intraosseous (IV/IO) dosing with an ETT level dose of a drug; and safely allowing for more accurate and timely dosing of resuscitation drugs, such as epinephrine, to a neonate (babies <5 kg). As discussed further herein, even experienced personnel are generally unable to meet NRP timeliness guidelines with existing approaches and the complexities of dose calculation and manipulation can lead to errors.
Accordingly, in an aspect, the present disclosure provides a kit comprising a syringe having a tip defining a male Luer taper fitting, and an adaptor defining a first end portion shaped to couple with the male Luer taper fitting and a second end portion shaped to cooperatively couple with an opening of an endotracheal tube. In an embodiment, the first end portion of the adaptor comprises a female Luer taper fitting configured to cooperatively couple with the male Luer taper fitting, where the second end portion comprises a barrel portion shaped to couple to an outer surface of an endotracheal tube injection line, and a tube portion positioned coaxially within the barrel portion and shaped to couple with an inner surface of the endotracheal tube injection line. In an embodiment, the adaptor is configured to transfer liquid between the syringe coupled to the first end portion and an endotracheal tube coupled to the second end portion.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
The foregoing aspects and many of the attendant advantages of the claimed subject matter will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
While illustrative embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.
Current protocols for delivering epinephrine and other resuscitation drugs to a neonate during an emergency require the use of an adult dose delivery system that is adapted and converted into a neonatal dose. These protocols require multiple equipment-assembly and dose-calculation steps that often result in delay in drug delivery and also lead to dosing errors. To address these challenges, the present disclosure provides kits for resuscitating a subject, such as a neonatal subject. The kits disclosed herein are a major advance on existing kits and protocols, with a focus on improving dosing safety and eliminating delays in neonatal resuscitation.
In an embodiment, the kits of the present disclosure include a syringe, such as a syringe for carrying and delivering a dosage of a liquid medication, and an adaptor coupled or couplable to an end of the syringe.
As shown in
In step #3, the practitioner must manually calculate a dose or choose a dose from multiple categories found on a Neonatal Epinephrine Dosing Chart. For example, as shown in
As mentioned herein, it is recommended by The American Academy of Pediatrics Neonatal Resuscitation Program that epinephrine should be prepared in 10 seconds during a neonatal code. The conventional process can be extremely difficult for a practitioner to perform in that time limit, especially because the pieces required do not exist in a single kit, and the practitioner needs to perform a calculation that is not standardized between hospitals, or sometimes even between individual healthcare teams.
In an embodiment, the kits of the present disclosure include a syringe, such as a syringe for carrying and delivering a dosage of liquid medication, and an adaptor, coupled or couplable, to an end of the syringe.
As shown, the adaptor 115 further defines a second end portion 120 shaped to cooperatively couple with an opening of an endotracheal tube (not shown). The second end portion 120 of the adaptor 115 may also be shaped to incorporate an integrated male Luer taper fitting within the endotracheal tube coupling. This integrated male Luer taper fitting provides the adaptor 115 with dual functionality so that it can alternately be used to cooperatively couple with another Luer-compatible device (such as a syringe) rather than an endotracheal tube. In some embodiments the second end portion 120 includes a barrel portion 135 shaped to couple to an outer surface of an endotracheal tube injection line, and a tube portion 120 positioned coaxially within the barrel portion 135 and shaped to couple with an inner surface of the endotracheal tube injection line. In some embodiments, the second end portion 120 is shaped to couple to an inner surface of the endotracheal tube injection line or cuff.
While a separate adaptor 115 couplable to both a syringe 105 and an ETT injection line is described, it will be understood that a syringe 105 permanently affixed and/or integrated with the functionality of the adaptor 115 (to form the combined unit illustrated in
In some embodiments, the kit includes a first syringe and a second syringe and a first and second adaptor, as illustrated in
Some conventional instructions with dosages provide individual weights or narrow weight ranges corresponding to a pharmaceutical dose. In an emergent situation, it may be challenging to determine a dosage corresponding to the individual weight or narrow weight range in a timely fashion. This may be doubly challenging with a neonatal subject or other subject where a precise subject weight is not known. Accordingly, by providing subject weight range information includes recommended dosages corresponding to weight ranges in the plurality of ranges of subject weights, a health care provider can determine an appropriate and/or recommended dosage based upon an estimated weight.
indicates data missing or illegible when filed
In an embodiment, the kit includes written instructions further including dosages of the pharmaceutical composition corresponding to the subject weight range information and a method of administering the pharmaceutical composition. In some embodiments, the written instructions are fixed weight-based dosing conversion. In some embodiments, the fixed weight-based dosing conversion is 1 mg/kg of epinephrine delivered via ETT, and 0.2 ml/kg of epinephrine for IV/IO. The written instructions may change overtime to account for NRP recommendations. In some embodiments, the ratios shown in the written instructions may be any appropriate dosing ratio. As shown in Table 1, the written instructions include methods of administration including administering the pharmaceutical composition through an endotracheal tube and through an intraosseous line and/or through an intravenous line. In some embodiments, the written instructions are on the barrel of the syringe (such as syringe 105) in place of or in addition to the written indicia. In some embodiments, the written indicia are located on the barrel of the syringe, and the written instructions are located elsewhere in the kit, as further described in
In an embodiment, the first syringe has a first color, and the second syringe has a second color, distinct from the first color. The first color and second color are suitable for further differentiating the differences and different intended uses of the first and second syringes. As shown, the first syringe intended for endotracheal tube delivery is labelled with gray markings in
In an embodiment, the first syringe 805A and second syringe 805B are configured and suitable to deliver a pharmaceutical composition to a subject by different delivery mechanisms. In some embodiments, the first syringe 805A is configured to couple to an endotracheal tube, while the second syringe 805B is configured to couple to a syringe. In some embodiments, the kit includes a box 820 or other suitable packaging for holding the two syringes and any other components of the kit 800.
In some embodiments, the kit includes safety features such as labeling each syringe with the appropriate drug and concentration throughout the entire process of delivering the drug. In some embodiments, each syringe is color coded on the barrel and the end of the syringe, such as red for IV/IO and yellow for ETT, though it is appreciated that the syringes may be labeled with any color. While
In an embodiment, a barrel size of the first syringe 805A is different than a barrel size of the second syringe 805B. Such a difference in barrel size between the first syringe 805A and the second syringe 805B can be useful in differentiating between uses for each syringe. As discussed further herein, in an embodiment, the first syringe 805A is suitable for use with an ETT. In an embodiment, the second syringe 805B is suitable for use with a needle or other structure configured for intravenous and/or intraosseous delivery of a pharmaceutical composition. Dosages for endotracheal delivery of a pharmaceutical composition are different than (and frequently larger than) dosages for intravenous/intraosseous delivery of the same pharmaceutical composition. Accordingly, it is useful in differentiating between the two syringes and their respective uses. A difference in barrel size between the first and second syringe is useful in this regard, as well as providing a capability of delivering a dosage of the pharmaceutical corresponding by the respective delivery mechanisms of the first and second syringe.
In an embodiment, components of the kit 800 include written indicia 825A, 825B, such as words or abbreviations, indicative of or denoting a use for components on which the written indicia are disposed. For example, in an embodiment, a syringe, such as the first syringe 805A, includes written indicia 825A including markings indicating that the syringe is for use with an endotracheal tube. In some embodiments, such written indicia 825A includes “ETT.” In an embodiment, the written indicia 825A, 825B further include markings indicating a dosage of a pharmaceutical composition when used with the endotracheal tube. Examples of such written indicia are illustrated in
In a further embodiment, the second syringe 805B includes second written indicia 825B including second markings, such as indicating that the second syringe is for use with an intravenous or intraosseous delivery line. In an embodiment, the second written indicia 825B further includes markings indicating a dosage of the pharmaceutical composition when used with the intravenous or intraosseous delivery line, such as shown in
In an embodiment, the first written indicia 825A indicating a dosage are different than the second written indicia 825B indicating a dosage, as described in detail in
In an embodiment, the kit 800 includes written instructions 810 for administering a dose of a pharmaceutical composition to a subject in need thereof. Such written instructions 810 can be in addition to and separate from written indicia 825A, 825B disposed on, for example, one or more syringes of the kit 800. As illustrated in
In an embodiment, the kit 800 includes a pharmaceutical composition for delivery to a subject in need thereof with the syringe. Such a pharmaceutical composition may be suitable for resuscitating a subject, such as a neonatal subject. In an embodiment, the pharmaceutical composition is the same pharmaceutical composition as indicated on the written indicia and/or the written instructions. In an embodiment, the pharmaceutical composition is selected from the group consisting of epinephrine, naloxone, atropine, vasopressin, lidocaine, and a combination thereof. In an embodiment, the pharmaceutical composition is epinephrine.
In an embodiment, the pharmaceutical composition is disposed within one or both of the first syringe and the second syringe 805A, 805B. In an embodiment, the pharmaceutical composition is disposed separately from the first and/or the second syringe 805A, 805B.
In operation, a practitioner can open the kit 800 in step #1. In some embodiments, the kit 800 contains two prefilled syringes 805A, 805B. The first syringe 805A may be an ETT syringe containing a single dose and the second syringe 805B may be an IV/IO syringe, containing a single dose. In step #2, the practitioner removes the desired syringe for the appropriate administration of the drug. In some embodiments, the appropriate administration includes IV/IO and ETT. In some embodiments, the kit 800 includes a recommended dosing chart (or instructions) 810 for quick reference on the top of the box 820 that contains the two syringes 805A, 805B. In step #3, the practitioner wastes the syringe to the appropriate weight that is marked, with written indicia 825A, 825B on either the ETT or IV/IO syringe. As discussed herein, in some embodiments, the ETT syringe 805A is a larger size to accommodate the larger required dose, and the IV/IO syringe 805B is smaller to accommodate the smaller required dose. In step #4,the practitioner administers the drug to the patient.
While illustrative embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional 63/166,542 filed Mar. 26, 2021, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63166542 | Mar 2021 | US |
