Improved method and system for the administration of a pulmonary surfactant by atomization

Patent metadata

Field	Value
Publication number	US-2016263333-A1
Application number	US-201415028670-A
Country	US
Kind code	A1
Filing date	Oct 16, 2014
Priority date	Oct 22, 2013
Publication date	Sep 15, 2016
Grant date	—

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

1 : A system for delivering a medicament comprising a pulmonary surfactant to spontaneously breathing patients, comprising:
i) a catheter adapted to reach the retro-pharyngeal region of the patient, the catheter including at least a first channel being adapted to convey in the patient's pharyngeal region a flow of liquid medicament and at least a second channel adapted to convey in the patient's pharyngeal region a pressurized flow of gas, ii) first pump means connected to a first end of the at least first channel, adapted to create a pressure which pushes the column of liquid medicament towards the second end of the at least first channel; iii) second pump means connected to a first end of the at least second channel, adapted to create the flow of pressurized gas; so that when the column of liquid medicament and the pressurized gas meet in the pharyngeal cavity, the liquid column is broken into a plurality of particles causing the atomized medicament to be delivered into the patient's lungs; iv) pressure detecting means, separate from the first and second channel for measuring a value indicative of the pressure in the patient pharyngeal cavity, such value being used to determine whether the patient is in an inspiration or in an expiration phase and wherein the first pump means are selectively activated only during inspiration phase.

2 : The system of claim 1 wherein the pressure detecting means include:
a third channel adapted to convey in the patients pharyngeal region a flow of a water solution;
third pump means connected to a first end of the third channel, adapted to create the flow of water solution;
a pressure sensor connected to the third channel for measuring a value indicative of the pressure on the flow of water solution.

3 : The system according to claim 1 , wherein the at least second channel includes a plurality of channel arranged around the first channel.

4 : The system of claim 3 wherein the cross section of the plurality of channels decreases towards the second end of the channels.

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

6 : The system according to claim 3 , wherein the catheter includes a partially rigid scaffolding.

7 : The system according to claim 2 , wherein the third channel is embedded in the catheter assembly, spaced apart form the at least first and at least second channel.

8 : The system according claim 7 , wherein the at least second channel includes a plurality of channels arranged around the first channel and wherein the third channel is one of the channels arranged around the first channel.

9 : The system of claim 7 , wherein the external cross section of the third channel is equal or lower to 2.5 mm.

10 : The system according to claim 1 , wherein the pulmonary surfactant is selected from the group consisting of modified natural pulmonary surfactants, artificial surfactants, and reconstituted surfactants.

11 : The system according to claim 1 , wherein the pressurized gas includes air.

12 : The system according to claim 2 , wherein the water solution includes a physiological saline (0.9% w/v sodium chloride) aqueous solution, optionally buffered at a physiological pH.

13 . The system according to claim 1 , wherein the patient is a spontaneously breathing pre-term neonate.

14 . A kit comprising:
a) a pharmaceutical composition comprising a pulmonary surfactant suspended in a pharmaceutically acceptable aqueous medium; b) the system according to claim 1 ; c) means for positioning and/or facilitating the introduction of the catheter into the retro-pharyngeal region; and d) container means for containing the pharmaceutical composition, the system and the positioning means.

15 : The kit of claim 14 wherein the means for positioning and/or facilitating the introduction of the catheter includes a laryngeal mask.

Assignees

• Chiesi Farm Spa

Inventors

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

Classifications

• A61M16/0488

  Mouthpieces; Means for guiding, securing or introducing the tubes (guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02) · CPC title

• A61M2230/40

  Respiratory characteristics · CPC title

• A61M2210/065

  Throat; Pharynx · CPC title

• A61M2230/005

  Parameter used as control input for the apparatus · CPC title

• A61M11/007 Primary

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