Method and system for the administration of a pulmonary surfactant by atomization

Patent metadata

Field	Value
Publication number	US-11197965-B2
Application number	US-201415028670-A
Country	US
Kind code	B2
Filing date	Oct 16, 2014
Priority date	Oct 22, 2013
Publication date	Dec 14, 2021
Grant date	Dec 14, 2021

Abstract

The system allows optimizing the dispensing of aerosol medicaments. In particular the system allows the administration of an exogenous pulmonary surfactant to very young patients (e.g. preterm neonates). A catheter ( 101 ) conveys atomized surfactant directly to the retropharyngeal region in order to increase efficiency of the medicament administration without being invasive: this is particularly important for very young patients, such as pre-term born neonates suffering from neonatal Respiratory Distress Syndrome (nRDS). The catheter is made of biocompatible flexible material (e.g. plastic material). It is possible to couple the catheter with a rigid scaffolding (e.g. metallic) to increase stiffness of the device and to improve easiness of positioning operations. The delivery of the atomized medicament is done by means of an air blasting technique.

First claim

The invention claimed is:

1. A system specifically arranged to deliver a medicament comprising a pulmonary surfactant to spontaneously breathing pre-term neonate patients, comprising:
a catheter specifically adapted to have a distal end thereof provided in the retro-pharyngeal region of the spontaneously breathing pre-term neonate patient without the presence of an intubation tube and a ventilator, the catheter including at least a first channel adapted to convey in the spontaneously breathing pre-term neonate patient's pharyngeal region a flow of liquid medicament including the pulmonary surfactant in the form of a column, and at least a second channel adapted to convey in the spontaneously breathing pre-term neonate patient's pharyngeal region a pressurized flow of gas,
a first pump connected to a first end of the at least first channel, that creates a pressure which pushes the column of liquid medicament towards the second end of the at least first channel;
a second pump connected to a first end of the at least second channel, that creates the flow of pressurized gas, wherein the catheter outputs the column of liquid medicament and the pressurized flow of gas according to an air blasting approach such that when the column of liquid medicament and the pressurized flow of gas meet in the pharyngeal cavity, the column of liquid medicament is broken into a plurality of particles to cause an atomized medicament to be delivered into the spontaneously breathing pre-term neonate patient's lungs; and
a pressure detecting system, separate from the at least first channel and the at least second channel, adapted to sense pressure swings in the spontaneously breathing pre-term neonate patient's pharyngeal cavity, such sensing being used to determine whether the spontaneously breathing pre-term neonate patient is in an inspiration or in an expiration phase, wherein
the first pump is selectively activated only during inspiration phase,
the pressure detecting system includes:
a third channel adapted to convey a flow of an aqueous solution in the retro-pharyngeal region of the throat of the spontaneously breathing pre-term neonate patient,
a third pump connected to a first end of the third channel that creates the flow of the aqueous solution, and
a pressure sensor connected to the third channel that measures a value indicative of pressure on the flow of the aqueous solution,

the pulmonary surfactant is poractant alfa,
the at least second channel includes a plurality of channels arranged around the at least first channel,
the at least first channel enlarges towards an end of the at least first channel, and
respective cross sections of the plurality of channels decrease towards ends of the channels, the decrease corresponding to the enlargement of the at least first channel.

2. The system according to claim 1 , wherein the third channel is outside of the catheter, axially offset and spaced apart from the at least first channel and the at least second channel.

3. The system according to claim 1 , wherein the catheter is made of flexible plastic material.

4. The system according claim 1 ,
wherein the at least second channel includes a plurality of channels arranged around the at least first channel, and
wherein the third channel is one of the channels arranged around the at least first channel.

5. The system of claim 1 , wherein an external cross section of the third channel is equal to or lower than 2.5 mm.

6. The system according to claim 1 , wherein the pressurized flow of gas includes air.

7. The system according to claim 1 , wherein the aqueous solution includes a physiological saline (0.9% w/v sodium chloride) aqueous solution, buffered at a physiological pH.

8. The system according to claim 1 , wherein the catheter is adapted to provide the plurality of particles for the atomized medicament having droplet median diameter of between 20-100 micron.

9. The system according to claim 1 , wherein
an output flow for the first pump is 9-18 ml/hr, and
an output flow for the second pump is less than 1 L/min.

Assignees

• Chiesi Farm Spa

Inventors

• Dellaca Raffaele
• Milesi Ilaria
• Di Cecio Mario
• Sewell Roger Fane
• Taylor Donal Joseph

Classifications

• A61M16/0486 Primary

  Multi-lumen tracheal tubes · CPC title

• A61M25/0026

  Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175) · CPC title

• A61M16/14

  by mixing different fluids, one of them being in a liquid phase · CPC title

• A61M16/06

  Respiratory or anaesthetic masks · CPC title

• A61M11/007 Primary

  Syringe-type or piston-type sprayers or atomisers · CPC title