WO1998004309A2

WO1998004309A2 - Device for controlled administration of medicines

Info

Publication number: WO1998004309A2
Application number: PCT/PL1997/000019
Authority: WO
Inventors: Zygmunt Podolec
Original assignee: Zygmunt Podolec
Priority date: 1996-07-27
Filing date: 1997-07-21
Publication date: 1998-02-05
Also published as: WO1998004309A3; AU3560597A; EP0928210A2

Abstract

A device for controlled administration of medicines, in a form of aerosol in particular, serving for a setting of the optimal moment for the medicine administration together with the respiratory air in cooperation with a medicine feeder, in particular with a device producing aerosol or a pressure container has a tube conduit (1) which sets a common air duct connected with the medicine feeder outlet (2) accommodated, on the one side, for mounting of the mouth piece (7) while, on the other side - the top piece (13) with the situated in the tube conduit (1) measuring system, which is a pneumatograph preferably made as an uncoupled module equipped with a sensor connected with the control system (10), which in turn is connected with the releasing system of the medicine feeder (2).

Description

Device for controlled administration of medicines

Field of the invention

The subject of the invention is a device for controlled administration of medicines, in a form of aerosol in particular, with assign of the optimal moment for medicine dispensation together with the inhaled air m cooperation with a device producing aerosol.

Background of the invention

There are known devices for administration of medicines in a form of aerosol, e.g., a nebulisator which contains a housing equipped with a chamber n which a dose of medicine is placed. The chamber is equipped with an inlet of compressed air which is used for continuous production of aerosol. The dispensation of a dose of medicine takes place at any chance moment without reference to the breathing activity parameters of the patient, among them, the phase of air inspiration and exhalation.

Pressurized containers filled with medicines are used commonly, as well. They are equipped with a valve activated by manual press on the stem. On the container may be set an end piece; it makes possible to direct the medicine dose to patient' s mouth or nose. There are known, as well, some chambers enhancing distribution of the released medicine into air. Such chambers are of a shape of a tube or cylindrical solid of revolution , with the inlet and outlet orifice. In one of tne orifices one sets the end piece of the pressuπzeα container wi .-^*, medicine. Spraying of medicine takes place within the internal space of the chamber ana the meaicme s inhaled oy patient oy use of the other orifice. The release of medicine's dose occurs every time at any moment oy manual press on the container valve stem. This way, the very air inspiration takes place at any arbitrary moment chosen by patient regardless of the patient's breathing activities parameters.

Disclosure of the invention

The essence of the solution consists in that it has a tube conduit which sets a common air duct connected with the medicine dose feeder outlet which can accommodate, on the one hand, a setting of a mouth piece while, on the other hand - a top piece, with a measuring system situated in the tube conduit; the measuring system is a pneumotachograph preferably made as an uncoupled module, equipped with a sensor, connected to the control system, which in turn is connected to the system releasing the medicine's feeder.

The pneumotachograph sensor consists in a system of two tubes; the external one of bigger diameter contains on the inside at least one internal tube of smaller diameter situated preferably concentrically. The segment of the internal tube of smaller diameter situated within the external tube of bigger diameter is shorter than the external tube; the measuring orifice is connected to the control system by one, at least, connector pipe.

The common air conduit has, at least, one non-return valve situated with respect to the pneumotachograph preferably opposite to the mouth piece.

At least one non-return valve has a set producing vibration of the air column present in the piping. The piping has on the side opposite to the mouth piece a source of vibrations, preferably ultrasounds, together with a measuring sensor of the reflected wave .

The external tube of bigger diameter is determined by two funnel links having the tube segments and pipe bell segments forming the air duct. From the zone of the fronts contact of the both links the connector pipes are taken out; they are situated parallelly and synchronously. The longitudinal axes of the longer ducts of the connector pipes follow parallel to the links fronts contact surface, however, the orifices of the shorter connector pipes ducts whose axes are perpendicular to the links fronts contact surface are situated within the distance not bigger than one/fourths of the diameter segment of the funnel link segment at its widest place.

On the longer tube segment of one of the links there is mounted a three-way pipe w th a medicine feeder in a form of a device for aerosol production.

The links are connected with a help of an elastic click in a shape of the V letter.

Another variant of the device has a mechanical system releasing the medicine feeder and comprises a pusher situated slidelily coaxially with respect to the valve stem equipped with a nozzle with the outlet situated to the conduit inside. The medicine feeder with the pusher is situated preferably between the tube conduit orifices forming its mlet/outiet; the common longitudinal axis of the medicine feeder and pusher overlapp each other preferably with the tube conduit diameter. The measurement system has a sensor situated in the tuoe conduit containing preferably at least one measuring orifice situated in this conduit preferably within the segment between its one orifice forming inlet /outlet and the feeder axis.

The nozzle outlet is situated parallel along the longitudinal axis of the tube conduit.

The sensor of the measurement system may De a middle housing in a form of a prism with the cross-section of a snape of unsymme- tπcal geometrical figure composed of two non-isosceles triangles with the parallel, preferably, common base situated, orefe- rably, on the longitudinal axis of the conduit and the arms equal m couples situated so as the longer arm of one triangle is situated opposite to the snorter arm of the other triangle. One measuring orifice, at least, is on the outside of the axis on which the common base of the both triangles lays .

The housing of the measurement system sensor may be an element of the pusher.

The sensor of the measurement system may be a necking of the conduit with one measuring orifice at least.

The tube conduit may have an extra top piece equipped with the orifices situated on the outside of the conduit longitudinal axis, preferably, in the side walls of the top piece while the nozzle outlet is directed towards the top piece.

The pusher may be displaced by an elastic element pressed up to the initial position by means of a mechanical-electrical drive system.

The pusher may be displaced by an elastic element pressed up to the initial position by means of a mechanical-electrical drive system manually and it has a release mechanism.

The very asset of this invention is elimination of administering of medicine at a chance moment. The device based on the invention enables to select the optimal moment for dispensing of the medicine dose to the patient in question.

Brief description of the drawings

The solution based on the invention is illustrated by the examples of realizations on the drawings enclosed; figure 1 presents said device along the longitudinal cross-section with a partial side-view, with the control system flow-sheet; figure

2 - the top piece along the longitudinal cross-section; figure

3 - the device from the front view; figure 4 - some variant of the measuring sensor along tne longitudinal cross-section with a partial side-view; figure 5 - two modules of the measuring sensor set frontally, figure 6 - some variant of the sensor with a funnel link n a variant with a prolonged tube beyond the funnel front and in a variant with a tube completed equally with the funnel front, figure 7 - a variant of said device for installation on a stand, figure 8 - a subsequent variant of said device along the longitudinal cross-section with a partial side-view, with a control system flow-sheet, figure 9 - the „V" element from figure 8, i.e., ring, measuring orifice and piping along the longitudinal cross-section, figure 10 - device presented in figure 8 along the cross-section through the mouth piece, figure 11 - a subsequent variant of said device along a part cross section, version with a sensor in a form of the two tubes, with a mechanical-electrical drive system, figure 12 - fragment of the pusher end piece mounted on the valve stem, figure 13 - variant of said device along a part cross-section, version with a sensor making a housing in a form of a prism of a rhomboid cross-section, with a top-piece, with a mechanical-electrical drive system, figure 14 - longitudinal cross-section of the non-symmetric housing, figure 16 - a subsequ^¬ ent variant of said device along a part cross-section, the ver^¬ sion with a sensor in a form of necking and measuring orifices, with a manual pull of the pusher spring.

Modes of carrying out the invention

Said device contains a tube conduit 1 which sets the air-duct connected to the medicine feeder outlet 2, which in the variant presented in figure 1 makes a device for production of aerosol, for example, in a form of the known nebulisator. In the air duct of the conduit 1 is a measuring sensor in a form of a twc pipe system - external tube 3, with a bigger diameter making at the same time the air duct conduit containing an internal tube 4 of smaller diameter, situated coaxially. The external tube 4 has the diameter equal to 10 % - 99* of the tube 3 external diameter. The segment of the internal tube 4 situated inside the external tube 3 is shorter than the latter.

The external tube 3 may be in a shape of two funnel links 5 having the tube segments and bell segments which set the air duct conduit . On one of the tube segments of one of the links 5, a three-way pipe 6 is mounted equipped with a mouth-piece 7. The side channel of the three-way pipe 6 is connected with a medicine feeder 2 in a form of a device for aerosol production.

The links 5 are coupled with the fronts of bigger diameter. The both links 5 have the same shape. The links 5 are coupled with an elastic click 5.

From the contact zone of the fronts of the both links 5 are lead out the connector pipes 9. They are situated parallel and coaxially. The longitudinal axes of the longer connector pipes 9 channels run parallel to the surface of the contact of the both links 5 fronts. The orifices of the shorter channels of the connector pipes 9 which have the axis perpendicular to the surface of the contact of the links 5 fronts are situated at a distance not bigger than one/fourths of the segment of the diameter of the bell link 5 segment at its widest place.

The measuring connector pipes 9 are coupled to the control system 10. The control system 10 by means of the valve 11 controls the source 12 of pressurized air supplied to the medicine feeder 2.

The measuring sensor is situated in the air duct of the tube conduit 1 and it may have various forms. In figure 4, a module sensor with the closure of the external tube 3 of bigger diameter between its edge and the internal tube 4 of smaller diameter is presented. In the variant presented in figure 5, the external tube 3 with the internal tube 4 form a module which is set by use of the tubes fronts and analogous symmetrical module. A nonsymmetrical variant is possible, as well.

On figure 6 is presented the variant of a sensor m which the external tuoe 3 is equippeα with the bell 5 having a part contracting from the closure side of the tube. There are possible various variants of that execution. The internal tube 4 may have tne front laying on the same plane as the bell closure or it may go out beyond the closure jutting out the external tube 3. Two bell links may be set using the fronts in the sym^¬ metrical and non-symmetrical variant.

The tube conduit 1 may have a closing top piece 13 on the side opposite to the mouth piece 7 equipped with, at least, one inspiration valve 15 which may be shut gravitationally Dy use of a spring or electromagnet. In the top piece 13 may be mounted an ultrasounds source 16 with a sensor measuring the reflected wave .

In the variant of the device presented in figure 7, the tube conduit 1 is connected to the pneumotachograph in a form of two bell links 5 with a net 17 mounted between them. The pneumota^¬ chograph may be mounted at an angle relative the longitudinal axis of the tube conduit 1.

In another variant containing another device for production of aerosol presented in figures 8, 9 and 10, the device consists of a system of two tubes - the external tube 3 of bigger diame^¬ ter containing the internal tube 4 of smaller diameter situated concentrically. The internal tube segment 4 situated on the in^¬ side of the external tube 3 is shorter than the latter.

One of the tubes of the system, preferably the internal one, forms a tube conduit of the medicine feeder 2 in the considered example of the known device for medicine feed in a form of aerosol .

The orifice of the external tube 3 between the edge of its front and the internal tube 4 has a closure so the air conduit is the internal tube 4.

The external tube 3 is mounted on the internal tube 4 by means of the ring 18 using the orientating and stiffening ribs 19. The ring 18 is made of an elastic materials.

On tne ring 18, a measuring orifice 20 is designed and connected with the connector pipe 9.

The measuring orifice 20 may be situated within the measurement area coveπnα the external wail of the tube 4 of smaller dia e- ter, the internal wall of the closure of the tube 3 of bigger diameter, the internal wall of the tube 3 of bigger diameter and the space confined to the mentioned walls.

The measuring orifice 20 is connected to the measuring system coupled with the control system 10. The control system 10 controls by means of the valve 11 the source of the compressed air 12.

Other variants of the device are presented in figures 11 - 16. In the wall of the tube conduit 1, between its inlet and outlet, there is mounted a container 2 containing the medicine under pressure. The container 2 may be closed in the mounting 21. The stem 22 of the valve of the container 2 is situated within the tube conduit 1.

Slidily, coaxially with respect to the stem 22 is situated a pusher 23 equipped with a nozzle 24 with an outlet situated parallel to the longitudinal axis of the conduit 1. The outlet of the nozzle 24 in the rest position is shifted with respect to the axis by the segment ,,s". The segment ,,x" is equal to the shift length of the stem 22 of the valve up to the working position. The common ax s of the stem 22 and the pusher 23 overlaps the diameter of the tube conduit 1.

The sensor of the measurement system is formed by an uncoupled module mounted at the outlet of the conduit 1. The module is in a form of a two-tuoes system; the external tube 3 of bigger diameter containing inside, at least, one internal tube 4 of smaller diameter situated concentrically. The segment of the internal tube 4 of smaller diameter situated on the inside of the external tube 3 of bigger diameter s shorter than the latter. The orifice of the external tube 3 of bigger diameter between ts edge and the internal tube 4 cf smaller diameter has a closure so the air conduit forms the internal tube 4 of smaller diameter. The front of the internal tube 4 may be situated on the same plane witn the closure of tne front of the external tube 3. The measuring orifice 20 is situated within the measurement area comprising the external wall of the tube 4 of smaller diameter, the internal wall of the closure of the tube 3 of bigger diameter, the internal wall of the tube 3 of bigger diameter and the space confined within the mentioned walls. The internal tube 4 is of the diameter amounting to 10 % to 99^ of the external diameter of the tube 3.

The external tube 3 of bigger diameter is mounted by means of the sealing rings 18.

The measuring orifice 20 of the sensor is connected with the measuring system 25 coupled to the control system 10 equipped with a monitor 26.

The measuring system cooperating with the control system 10 can measure different parameters of air flow, for instance, pressure, volume, flow direction, presence of the flow or its lack. The measurement may be also realized on the basis of the other parameters dependent of the physical changes of the state of the air, e.g., temperature or humidity.

By another variant of the device presented in figure 13 and figure 14, in the tube conduit 1 is situated the housing 2ⁿ of the pusher 23. The housing 27 is in a form of a prism with a rhomboid cross-section and equipped with at least one measuring orifice 28 situated preferably on the edges equal to the diameter of the tube conduit 1 within the segment between the nozzle 24 and the contact of the edges to the wall of that conduit 1. The measuring orifice 28 is connected by means of a channel with the measuring system 25 of the control system 10.

In the variant of realization presented in figure 15, the housing 27 of the pusher 23 is of a form of a prism with the cross section in a shape of a geometrical nonsymmetrical figure composed of two triangles with unequal arms and common base situated on the longitudinal axis of the housing and the arms equal in pairs situated so that the longer arm of one triangle exists opposite to the shorter arm of the other triangle while tne me- asuπng orifices 28 are on the outside of the axis on which lays the common basis of the triangles.

The sensor of the measuring system in another variant of execution may be in a form of a tube with necking 29. Before and/or after the necking 29 are situated the measuring orifices 30.

The sensor of a measuring system may have another form, e.g., it can be a rotating element of a turbine or an element reacting to the temperature changes.

A subsequent variant of realization comprises the end piece 13 with the orifices 31 mounted permanently or in an uncoupled way on the outlet of the tube conduit 1. The top piece 13 is equipped with the orifices 31 situated in the side walls. In the considered example, the nozzle 24 is directed towards the opposite direction, to the top piece 13.

The pusher 23 is displaced by means of the spring 32. Straining of the spring 32 may be realized by use of the mechanical-electrical drive system 33.

Another possibility is a manual straining by means of the lever 34 of any shape and location cooperating with the roll 35 with the pusher blocking 23 and the trigger 36.

Another variant is straining of the spring 32 by means of the energy of compressed gas. The compressed gas may be supplied from a separate source or one can use the gas contained in the feeder 2 which is filled with a medicine.

By usage of the device, the patient breathes through the tube conduit 1 by means the mouth piece i . The control system 10 by use of the measuring link measures the oreatning parameters. At a proper, optimal moment of breathing, the control system 10 activates tne medicine feeder 2, e.g., the device for production of the aerosol and the medicine is dispensed. In the case of the medicine feeder in a form of a pressure container proceeds the action of the mechanical or mechanical-electrical releasing system and the medicine is dispensed. The device enables dispensing of a medicine in a form of aerosol during inspiration. The administering of medicine depends on preparation of the breathing system to reception of the medicine by determination of the exhalation quantity which is required for dosing of medicine during inspiration.

The device enables administering of a medicine during inspiration phase in a continuous or impulse mode. The device makes possible also the control of the size of aerosol particles by a change of the medicine generation interval time.

There is possible to calculate the volume of inspiration containing aerosol, i.e., aerosol dose.

In the variant of execution with a top piece 13, the application of non-return valves - inspiration valve 15 and exhalation valve 16 makes possible as well the measurements of the resistances of breathing routes under the known rule.

Application of an ultrasound source and an reflected wave sensor enables measurement of breathing routes patency, in parti^¬ cular, monitoring of the changes during administering of medicine as well as during the free breathing.

In that variant of realization, the inspiration valve and, in particular, exhalation valve may be controlled in such a manner that the air column vibrations are produced; they enhance the deposition of aerosol and the evacuation of the discharge from the breathing routes .

The cases presented above do not limit the possibilities of realizing the invention, being only illustrative examples of the basic idea of the selecting the optimal moment for dispensing of the mec cine dose to the patient.

Claims

1. A device for controlled administration of medicines, m a form of aerosol in particular, serving for a setting of the optimal moment for the medicine dispensation together with the respiratory air m cooperation with a medicine feeder, in particular with a device producing aerosol or a pressure container is characteristic m that it has a tube conduit (1) which sets a common air duct connected with the medicine feeder outlet (2) accommodated, on the one side, for mounting of the mouth piece (7) while, on the other side - the top piece (13) with the situated in the tube conduit (1) measuring system, which is a pneumatograph preferably made as an uncoupled module equipped with a sensor connected with the control system (10), which in turn is connected with the releasing system of the medicine feeder (2) .

2. The device as claimed m claim 1 is characteristic in that the pneumotachograph sensor comprises a system of two tubes; the external one (3) of bigger diameter contains inside at least one internal tube (4) of smaller diameter situated preferably concentrically while the segment of the internal tube (4) of smaller diameter situated inside the external tube (3) of bigger diameter is shorter than the external tube while the measurement orifice is connected to the control system (10) by means of at least one connector pipe (9) .

3. The device as claimed in claims 1 - 2 is characteristic in that the common air conduit has at least one non-return valve (15), (16) situated with respect to the pneumotachograph preferably opposite to the mouth piece.

4. The device as claimed m claims 1 - 3 is characteristic in that at least one non-return valve (15), (16) has a set producing vibration of the air column present in the piping.

5. The device as claimed in claims 1- 4 is characteristic in that the piping (1) has on the side opposite to the outn piece (7) a source of vibrations (16), preferably ultrasounds, together with a measurement sensor of the reflected wave.

6. The device as claimed in claims 1 - 5 is characteristic in that the external tube (1) of bigger diameter is determined by two funnel links (5) having the tube segments and pipe bell segments forming the air duct.

7. The device as claimed in claims 1 - 6 is characteristic in that from the zone of the fronts contact of the both links (5) the connector pipes (9) are taken out situated parallel and synchronously while the longitudinal axes of the longer ducts of the connector pipes (9) follow parallel to the links (5) fronts contact plane whereas the orifices of the shorter connector pipes ducts (9) whose axes are perpendicular to the links (5) fronts contact plane situated within the distance not bigger than one/fourths of the diameter segment of the funnel link (5) segment at its widest place.

8. The device as claimed in claims 1 - 7 is characteristic in that on the longer tube segment of one of the links (5) there is mounted a three-way pipe (6) equipped with the mouth piece (7) while the side duct of the three way pipe (6) is connected with the medicine feeder (2) in a form of a device for aerosol production.

9. The device as claimed in claims 1- 8 is characteristic in that the links (5) are connected with a help of an elastic click (8) in a shape of the V letter.

10. The device as claimed in claim 1 is characteristic in that it has a mechanical system releasing the medicine feeder (2) comprising a pusher (23) situated slidelily coaxially with respect to the valve stem (22) equipped with a nozzle (24) with the outlet situated to the inside of the tube conduit (1) while the medicine feeder (2) with the pusher (23) is situated preferably between the tube conduit orifices (1) forming its inlet/outlet and the common longitudinal axis of the medicine feeder (2) and of the pusher (23) overlapp each other preferably with the tube conduit (1) diameter whereas the measurement system has a sensor situated in the tube conduit (1) containing preferably at least one measuring orifice (2)), (28), situated in this conduit (1) preferably within the segment between its one orifice forming inlet/outlet and the pusher axis (23) .

11. The device as claimed in claim 10 is characteristic in that the nozzle outlet (24) is situated parallel along the longitudinal axis of the tube conduit (1) .

12. The device as claimed in claim 1 is characteristic in that the sensor of the measurement system may be a middle housing (27) in a form of a prism with the cross-section of a shape of unsymmetrical geometrical figure composed of two non-isosceles triangles with the parallel preferably common base situated preferably on the longitudinal axis of the tube conduit (1) and the arms equal in couples situated so that the longer arm of one triangle is situated opposite of the shorter arm of the other triangle whereas one measuring orifice (28), at least, is on the outside of the axis on which the common base of the both triangles lays.

13. The device as claimed in claim 12 is characteristic in that the housing (27) of the measurement system sensor may be an element of the pusher (23).

14. The device as claimed in claim 12 is characteristic in that the sensor of the measurement system may be a necking (29) of the tube conduit (29) with one measuring orifice (30) at least.

15. The device as claimed in claim 10 or 12 is characteristic in that the piping (1) may have an extra top piece (13) equipped with the orifices (31) situated on the outside of the conduit (1) longitudinal axis preferably in the side walls of the top piece (13) while the nozzle outlet (24) is directed towards the top piece (13).

16. The device as claimed in claim 10 or 12 is characteristic in that the pusher (23) may be displaced by an elastic element (32) pressed up to the initial position by means of a mechanical-electrical drive system (33) .

17. The device as claimed in claim 10 or 12 is characteristic in that the pusher (23) may be displaced by an elastic element (32) pressed up to the initial position manually and it has a release mechanism (36).