WO2017136470A1

WO2017136470A1 - System and method for delivering medicament

Info

Publication number: WO2017136470A1
Application number: PCT/US2017/016087
Authority: WO
Inventors: Corey COMMAROTO; Kate Ackerman
Original assignee: Ony Inc.
Priority date: 2016-02-01
Filing date: 2017-02-01
Publication date: 2017-08-10

Abstract

A laryngeal mask airway ("LMA") is disclosed. The LMA may have a mask-portion with two openings. One of the openings may be used for conducting inhaled and exhaled gases to and from a patient, and the other of the openings may be used for delivering a medicament to the patient. The LMA may include features that assist and facilitate with determining the CO2 concentration of the breathing gas being provided to the patient.

Description

SYSTEM AND METHOD FOR DELIVERING MEDICAMENT

Cross-Reference to Related Application

[0001] This application claims the benefit of priority to U.S. provisional patent application serial number 62/289,396, filed on February 1, 2016.

Field of the Invention

[0002] The present invention relates to devices/systems/methods of delivering medicaments to a patient. For example, the medicament may be a surfactant, which is commonly used to facilitate breathing in neonatal patients. Background of the Invention

[0003] A type of medical device called a "laryngeal mask airway" ("LMA"), which is sometimes referred to as a "supra laryngeal airway" or a "supra glottic airway", is a medical device used to facilitate routine and emergency airway management by medical personnel, such as anesthesiologists and emergency medical technologists. Currently, LMAs are not widely used for airway management in some medical settings, such as neonatal intensive care units (NICUs) or by neonatal practitioners such as neonatologists, neonatal nurse specialists, and neonatal respiratory care therapists. In a NICU setting, LMAs are not normally used because LMAs are not designed for long term airway management, and airway management in the NICU, especially long term airway management, has been effectively accomplished by endotracheal intubation. In addition, neonatal practitioners have been routinely trained in endotracheal intubation for emergency and long term airway management, and are therefore comfortable with using endotracheal intubation despite negative side effects to the patient.

[0004] Some treatments for neonatal patients involve the administration of a surfactant to the patient's respiratory system. Surfactant replacement therapy is a standard treatment for neonatal Respiratory Distress Syndrome (RDS). Currently surfactant administration/delivery is almost exclusively accomplished via an endotracheal tube. But, given the problems often associated with endotracheal tubes, an alternative is needed. [0005] Given the problems associated with endotracheal tubes, a widely accepted goal is to avoid or limit the use of endotracheal intubation for neonatal airway management and respiratory support. That goal seeks to reduce risks associated with endotracheal tube placement, which include trauma, pain, hypoxemia, bradycardia, systemic hypertension, and increased intracranial pressure. Also, there are risks associated with long term use of endotracheal tubes, and among those risks are trauma, pain, discomfort, pulmonary infection, pulmonary barotrauma, and bronchopulmonary dysplasia, to name a few.

[0006] There are two other prior-art methods which may be used to deliver medicaments such as surfactants, but both of these methods require tracheal catheterization, and therefore are quite invasive. The first of these two methods uses a semi-rigid vascular catheter to position the tip of the catheter in the trachea under direct laryngoscopy without the need for Magill's forceps (forceps are not needed due to the stiffness of the catheter).

Surfactant is then delivered to the trachea via the catheter and the catheter is removed. The second of these two methods uses a soft tube (such as a feeding tube) and Magill's forceps (forceps are needed due to the pliable nature of the tube) to position the tip of the tube in the trachea under direct laryngoscopy. Surfactant is then delivered to the trachea via the tube and the tube is removed. Neither of these two methods have gained favor in clinical practice and are rarely used because they are complex and require highly trained medical personnel.

[0007] As compared to endotracheal intubation and the two tracheal catheterization methods, placement of an LMA may be performed by medical personnel having minimal training. But, proper placement is not always easily accomplished. In addition, most existing LMAs are not designed to deliver medicaments, such as surfactants, or to indicate to medical personnel when the LMA is properly positioned for delivering medicaments.

Summary of the Invention

[0008] The invention may be embodied as a laryngeal mask airway ("LMA") having a mask-portion. The mask-portion has a body-part and a cuff, wherein the body-part has two openings. One of the openings may be used for conducting inhaled and exhaled gases to and from a patient, and the other of the openings may be used for delivering a medicament to the patient. The LMA may include a medicament delivery tube having a receiving end and a delivery end. The delivery end of the delivery tube may be connected to the body-part and coincide with the opening for delivering medicament. The LMA may include an airway tube that is connected to the body-part so as to coincide with the opening for conducting inhaled and exhaled gases to and from the patient.

[0009] Attached to the receiving end of the medicament delivery tube may be a port- connector to be used for delivering medicament to the delivery tube. The port-connector may include a valve that is biased to the closed position, and which can be opened when delivering medicament to the delivery tube. So as to facilitate delivery of the medicament to the delivery tube, the port-connector may be located on an end of the delivery tube that is distal from the mask-portion.

[0010] The medicament delivery tube may be located to extend along an exterior surface of the airway tube. Alternatively, the medicament delivery tube may be, at least in part, a channel within a wall Of the airway tube. [001 1] An LMA according to the invention may include features that facilitate and assist with determining a C02 content of the breathing gas traveling in the airway tube. One such feature may be a C02 sampling port, which may be used to connect a C02 detector in gas-communication with the airway tube. Such a sampling port may be positioned on the airway tube distal from the mask-portion. [0012] A different feature that may be used to facilitate and assist with determining a

C02 content is an in-line C02 detector. For example, such a detector may have a color- changing C02 -detecting membrane exposed to breathing gas that travels through a tube that connects the airway tube with a circuit adapter. Such a C02 detector may be positioned on the airway tube distal from the mask-portion. [0013] The invention may be embodied as a method of delivering a medicament to a patient's airway. In one such method, an LMA is placed in the patient's airway. The LMA may have a mask-portion having a body-part and a cuff. The body-part may have two openings, wherein one of the openings is for conducting inhaled and exhaled gases to and from a patient, and the other of the openings is for delivering a medicament to the patient. The LMA may have a medicament delivery tube and an airway connecting tube, such as those described above. A medicament filled syringe may be connected to the port-connector, and the medicament may be forced into the delivery tube with the syringe. In one embodiment of a method according to the invention, a C02 measurement may be read, and the LMA may be adjusted in order to change the C02 measurement in order to better position the LMA for delivery of the medicament.

Brief Description Of The Drawings [0014] For a fuller understanding of the nature and objects of the invention, reference should be made to the accompanying drawings and the subsequent description. Briefly, the drawings are:

Figure 1 is a schematic illustrating an LMA according to the invention;

Figure 2 is a schematic illustrating another LMA according to the invention;

Figure 3 A is a schematic illustrating yet another LMA according to the

invention;

Figure 3B is a side-view schematic of a C02 detector having a color- changing membrane; and

Figure 4 depicts collars on an airway tube.

Further Description of the Invention

[0015] Our invention is an LMA 10 that facilitates administering a medicament to a patient's airway, and is believed to be safer, quicker, and more efficient than prior art methods of administering a medicament. Our invention may be embodied as an LMA 10 that minimizes the need for additional materials or adapters. With our invention, we foresee expanding current LMA size offerings so that our invention is offered in sizes that are dimensioned to fit a range of neonatal patients, which may include full-term newborns to very premature newborns. An LMA 10 according to our invention could be a single-use device, and therefore may be embodied as a "disposable" device.

[0016] Figures 1 - 3 A depict LMAs 10 that are in keeping with the invention. Such

LMAs 10 may include a port-connector 13 and a medicament delivery tube 16 (which may be comprised of a channel or lumen) that are dedicated to the delivery of a medicament, such as a surfactant, to a mask-portion 19 of the LMA 10. Depicted in Figures 1 - 3 A are three different LMAs 10, each having a mask-portion 19 having a body-part 22 and a cuff 25. Extending from a breathing-gas opening 28 in the body-part 22 is an airway tube 31. The delivery tube 16 and the airway tube 31 may each end at the body-part 22 so that one or both tubes 16, 31 do not extend into the cavity defined by the cuff 25 and body-part 22.

[0017] On an end of the airway tube 31 distal from the breathing-gas opening 28 may be an adapter 34 (15 mm is a standard size), which may be used to provide a connection to a breathing-gas supply system. Such a supply system may take the form of a circle-circuit or a resuscitation device (e.g. ambu-bag or t-piece resuscitator). The airway tube 31 allows breathing-gas to travel between the airway tube adapter 34 and the breathing-gas opening 28 in the body-part 22.

[0018] The cuff 25 facilitates sealing of the mask-portion 19 to the patient's airway, while at the same time isolating the patient's esophagus from the patient's airway. The size and shape of the cuff 25 may be adjusted by providing or removing air via the cuff-inflation port 37. Alternatively, the cuff 25 may be self-pressurizing, or may utilize a self-sealing gel in order to provide a close fit with the patient's airway. The LMAs 10 depicted in Figures 1 - 3A each have an air-filled cuff 25 and a cuff-inflation port 37, which may be used to adjust the size and stiffness of the air-filled cuff 25. The cuff-inflation port 37 may be located distally away from the mask-portion 19 to facilitate efforts by medical personnel with adjusting the cuff 25.

[0019] A medicament delivery tube 16 and port-connector 13 are shown. Figure 1 shows an embodiment of the invention in which the medicament delivery tube 16 extends along an external surface of the airway tube 31 to a medicament-opening 40 in the body-part 22. In such an embodiment, the medicament delivery tube 16 may be permanently bonded (e.g. by an adhesive) to the airway tube 31, or formed as an integral part of the airway tube 31 during manufacture. Alternatively, one or more collars 73 may be permanently bonded to the airway tube 31 (or formed as an integral part of the airway tube 31 during manufacture), and the medicament delivery tube 16 may extend through the collars 73 and thereby held to the airway tube 31. See Figure 4. Figure 2 shows an alternative embodiment in which at least a portion of the medicament delivery tube 16 is a channel 46 in the wall of the airway tube 31. Such a channel 46 may extend from a distal end 49 of the airway tube 31 to the body-part 22 of the mask-portion 19. [0020] The port-connector 13 may include a valve in order to seal the distal end 52 of the medicament delivery tube 16 when a syringe 55 is not attached to the port-connector 13. The syringe 55 may be used to provide medicament to the medicament delivery tube 16 via the port 13. By using a valved delivery port 13, a closed system may be provided with respect to ventilation of the patient, whether or not the syringe 55 is connected to the port- connector 13.

[0021] To use our LMA 10, a neonatal practitioner (or other medical services provider) would connect a medicament-filled syringe 55 to the port-connector 13. Using the syringe 55, medicament is forced from the syringe 55 into the medicament delivery tube 16 via the medicament delivery port 58, and to the medicament-opening 40 in the body-part 22 of the mask-portion 19. The port-connector 13 is located distally away from the mask- portion 19 so as to facilitate ease of connection of the syringe 55 to the port-connector 13.

[0022] By including the medicament delivery tube 16 and the port-connector 13 in our LMA 10, there is no need to utilize additional materials, such as (a) cut-to-length feeding tubes or suction tubes, or (b) special airway tube adapters (such as "Y" or "T" adapters), in order to avoid the need to disconnect critical respiratory support devices (such as positive pressure ventilatory assist devices, or CPAP systems) during medicament administration. As such, our invention would make medicament administration via an LMA safer, easier, quicker and more efficient. In addition, an LMA 10 according to our invention could be offered in sizes not currently available, and thus our LMA 10 can be dimensioned to fit a range of neonatal patients requiring medicament treatment by providing differently sized mask-portions 19.

[0023] The port-connector 13 and delivery tube 16 (which may be comprised of a channel or lumen) may be dedicated to the delivery of a particular medicament, such as a surfactant. The port-connector 13 may be shaped to permit a particular type of syringe 55, which is used only for a particular medicament. In this manner, the LMA 10 may be configured to accept and deliver only one type of medicament via the delivery tube 16. For example, when the desired medicament is a surfactant, the port-connector 13 may be sized according to ISO 80369 standards, thereby preventing syringes 55 with medicaments other than surfactant from being connected to the LMA 10.

[0024] Our LMA 10 may include features that facilitate proper positioning of the

LMA 10 within the patient. For example, Figure 3 depicts an LMA 10 according to the invention that has the ability to facilitate the measurement of C02 in the airway tube 31, which may be used to assist medical personnel (such as a nurse or doctor) with properly positioning the LMA 10. The airway tube 31 may include a sampling port 61 , which can be used connect a digital C02 monitor. Alternatively, or in addition, a color-changing C02 detector 64 may be included within a chamber 67. A translucent window 70 is provided to allow medical personnel to see the detector 64. Figures 3A and 3B show that the chamber 67 may be attached to the airway tube 31 and the circuit adapter 34 so that breathing gas contacts the color-changing membrane-C02 -detector 64. The membrane-C02-detector 64 changes color when exposed to C02 in the patient's breathing gas. With experience, medical personnel can know which color is associated with proper placement of the LMA 10 within the patient, and which colors are associated with improper placement of the LMA 10. In this manner, medical personnel may easily visualize a color change of the membrane 64 and thereby quickly understand changes in the C02 content of the gas being exchanged. A change in C02 content may be associated with a change in the quality of the seal formed by the cuff 25 inside the patient, and thus utilized by medical personnel to understand when an optimum seal between the LMA 10 and the patient has been achieved. [0025] The C02 sampling port 61 and/or the detecting chamber 67 are preferably located at the distal end 49 of the LMA's airway tube 31, near to where the circuit adapter 34 is attached. In this manner, C02 monitoring occurs in the area that is easily accessible to medical personnel. [0026] When equipped with a C02 monitor, our LMA 10 provides medical personnel with the ability to use capnography in conjunction with an LMA 10 in order to achieve proper placement of the LMA 10. By verifying that the LMA 10 is in the proper position prior to administration of a medicament, the medicament can be more accurately and efficiently delivered to the patient. For example, more of the surfactant (or other medicament) will be delivered to the lungs, rather than to the stomach, when the LMA 10 is properly located within the patient because the LMA 10 properly seals with the patient. When the LMA 10 is correctly placed and used with a digital C02 monitor connected to the C02 sampling port 61, a waveform and end-tidal C02 reading may be provided to the medical personnel (usually within seconds) after the first ventilation is delivered to the patient. Furthermore, our capnography-facilitating LMA 10 is able to provide objective, breath-to-breath feedback regarding ventilation throughout the duration of patient contact, and thereby facilitates the delivery of information about C02 changes in order to quickly signal to medical personnel if the LMA 10 is displaced or improperly positioned, or a problem with ventilation develops. With such information, medical personnel are able to make adjustments to the LMA so that the LMA is properly positioned to facilitate efficient administration of the medicament.

[0027] Although the present invention has been described with respect to one or more particular embodiments, it will be understood that other embodiments of the present invention may be made without departing from the spirit and scope of the present invention. Hence, the present invention is deemed limited only by the appended claims and the reasonable interpretation thereof.

Claims

What is claimed is:

1. An LMA comprising: a mask-portion having a body-part and a cuff, the body-part has two openings, wherein one of the openings is for conducting inhaled and exhaled gases to and from a patient, and the other of the openings is for delivering a medicament to the patient; a medicament delivery tube having a receiving end and a delivery end, wherein the

delivery end is connected to the body-part and coincides with the opening for delivering medicament; an airway tube connected to the body-part so as to coincide with the opening for

conducting inhaled and exhaled gases to and from the patient.

2. The LMA of claim 1, further comprising a port-connector attached to the receiving end of the medicament delivery tube.

3. The LMA of claim 1, wherein the receiving end is located distal from the mask-portion.

4. The LMA of claim 1, wherein at least a portion of the medicament delivery tube extends along an exterior surface of the airway tube.

5. The LMA of claim 1, wherein the medicament delivery tube is comprised of a channel within a wall of the airway tube.

6. The LMA of claim 1, further comprising a C02 sampling port.

7. The LMA of claim 6, wherein the C02 sampling port is positioned on the airway tube distal from the mask-portion.

8. The LMA of claim 1 , further comprising a C02 detector.

9. The LMA of claim 8, wherein the C02 detector is positioned on the airway tube distal from the mask-portion.

10. The LMA of claim 1, further comprising a cuff-inflation port for adjusting the cuff.

1 1. A method of delivering a medicament to a patient's airway, comprising: placing an LMA in the patient's airway, the LMA having: a mask-portion having a body-part and a cuff, the body-part has two openings, wherein one of the openings is for conducting inhaled and exhaled gases to and from a patient, and the other of the openings is for delivering a medicament to the patient; a medicament delivery tube having a receiving end and a delivery end, wherein the delivery end is connected to the body-part and coincides with the opening for delivering medicament, and the receiving end includes a port-connector; an airway tube connected to the body-part so as to coincide with the opening for conducting inhaled and exhaled gases to and from the patient. connecting a medicament filled syringe to the port-connector; forcing the medicament into the delivery tube with the syringe.

12. The method of claim 1 1, further comprising reading a C02 measurement, and adjusting the LMA in order to change the C02 measurement.