WO2013033589A1

WO2013033589A1 - Manual insufflator-exsufflator

Info

Publication number: WO2013033589A1
Application number: PCT/US2012/053431
Authority: WO
Inventors: John Bach; Lou SAPORITO; Patrick FOYE
Original assignee: University Of Medicine And Dentistry Of New Jersey
Priority date: 2011-09-02
Filing date: 2012-08-31
Publication date: 2013-03-07

Abstract

An inexsufflation device including a hollow body having a substantially closed distal end which defines a fluid port configured to be fluidly connected to a patient interface. A plunger assembly is positioned such that a piston thereof is positioned in the hollow body and sealingly engages an inside surface thereof to define a fluid chamber between the piston and the substantially closed distal end. The plunger assembly is moveable relative to the hollow body to expel fluid in the fluid chamber through the fluid port or draw fluid into the fluid chamber through the fluid port. At least one valve is in fluid communication with the fluid chamber and configured to control a maximum positive or negative pressure within the fluid chamber.

Description

MANUAL INSUFFLATOR-EXSUFFLATOR

FIELD OF THE INVENTION

[0001] The present invention relates to the field of medical devices used to facilitate a patient in coughing and expelling tracheobronchial secretions.

STATEMENT REGARDING FEDERALLY FUNDED RESEARCH

[0002] This invention was made with government support under Grant FD-R-000649-01 awarded by the Food and Drug Administration. Accordingly, the U.S. Government has certain rights in this invention.

BACKGROUND OF THE INVENTION

[0003] A serious problem for many patients with neuromuscular weakness including high- level spinal cord injury, as well as many other physical disorders and advanced old age is that they lack sufficient muscle strength and/or muscle control to effect the full inhalation and explosive exhalation required to cough and expel bronchial secretions from the lungs. Inability to remove these secretions can result in bacterial infection (pneumonia) and oxyhemoglobin desaturation (low blood oxygen) and even lead to respiratory failure, hospitalization, and death. These dangers are further intensified in patients with poor muscle control for protecting the airways because they can aspirate saliva, foods, or liquids into their lungs, a dangerous occurrence which can result in the problems noted above. [0004] As a result of the many types of patients facing this life-threatening problem the CoughAssist™ mechanical inexsufflation device was developed and commercialized. The CoughAssist™ device facilitates a patient's inhalation and forceful exsufflation to increase cough flows to cough out airway secretions for weak patients. This device dramatically improved the quality of life and care of patients unable to cough effectively, preventing episodes of respiratory failure and, often, the need for invasive mechanical ventilation.

[0005] While this device, and others like it, function to address this medical need, they are prohibitively heavy, cumbersome, very expensive (over $7,000), and require electricity. Thus, there remains a need for a practical, affordable, portable and user-friendly device for this highly dangerous situation.

SUMMARY OF THE INVENTION

[0006] The present invention provides a portable and convenient mechanical inexsufflation device to assist patients with inhalation and forceful exsufflation to expel airway debris. It can assist patients in need with respiration as well as for coughing. It is intended for use in various locations and contexts, including, but not limited to, hospitals, ambulances, administration of medical care in third world countries or other places where resources or facilities may be lacking, as well as for personal use.

[0007] In one aspect, at least one embodiment of the invention provides an inexsufflation device including a hollow body having a substantially closed distal end which defines a fluid port configured to be fluidly connected to a patient interface. A plunger assembly is positioned such that a piston thereof is positioned in the hollow body and sealingly engages an inside surface thereof to define a fluid chamber between the piston and the substantially closed distal end. The plunger assembly is moveable relative to the hollow body to expel fluid in the fluid chamber through the fluid port or draw fluid into the fluid chamber through the fluid port. At least one valve is in fluid communication with the fluid chamber and configured to control a maximum positive or negative pressure within the fluid chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:

[0009] Fig. 1 is a perspective view of an exemplary inexsufflation device according to an exemplary embodiment of the invention.

[0010] Fig. 2 is a perspective view illustrating exemplary components of a patient interface useable with the inexsufflation device of the invention.

[0011] Fig. 3 is a cross-sectional view of an exemplary inexsufflation device in a ready to use position with the plunger in a mid-volume position.

[0012] Fig. 4 is a cross-sectional view similar to Fig. 3 illustrating the inexsufflation device after the insufflation stroke.

[0013] Fig. 5 is a cross-sectional view similar to Fig. 3 illustrating the inexsufflation device after the exsufflation stroke.

[0014] Fig. 6 is a cross-sectional view of another exemplary inexsufflation device in a ready to use position with the plunger in a full-volume position.

[0015] Fig. 7 is a cross-sectional view along the line 7-7 in Fig. 6. [0016] Fig. 8 is a cross-sectional view similar to Fig. 6 illustrating the inexsufflation device after the insufflation stroke.

[0017] Fig. 9 is a cross-sectional view similar to Fig. 6 illustrating the inexsufflation device after the exsufflation stroke.

DETAILED DESCRIPTION OF THE INVENTION

[0018] In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms "distal" and "proximal" refer to the directions "away from" and "closer to," respectively, the body of the care giver applying the inexsufflation device to a patient. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes a preferred embodiment of the present invention.

However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiment described herein.

[0019] The present invention provides a portable and convenient mechanical inexsufflation device to assist patients with inhalation and forceful exsufflation to expel airway debris. This portable cough assistance device is comprised of a large syringe that delivers air through an adapter into a face mask or airway tube. It can assist patients in need with respiration as well as for coughing.

[0020] This device is intended for use in various locations and contexts, including, but not limited to, hospitals, ambulances, administration of medical care in third world countries or other places where resources or facilities may be lacking, as well as for personal use - in one's home, place of work and for travel and as a back up in the event of the failure of the commonly used device, the CoughAssist™ mechanical inexsufflation device (Respironics Int. Inc.).

[0021] Referring to Fig. 1, an exemplary inexsufflation device 10 in accordance with an embodiment of the invention will be described. The device 10 includes a hollow body 12 which preferably has a cylindrical configuration. The body 12 extends between a distal end 13 and a proximal end 15. The distal end 13 is substantially closed by end wall 14 but includes a fluid port 17. In the present embodiment, the fluid port 17 is defined through a stem 16 extending from the end wall 14.

[0022] The stem 16 is preferably configured for connection to an appropriate oro-nasal patient interface 50 as illustrated in Fig. 2. The stem 16 may connect directly with a portion 52 of the interface 50 or an adapter (not shown) may be provided. The patient interface 50 may be a facemask, a mouthpiece, a lip seal, a tracheostomy tube adapter or any other desired interface component. Fig. 2 also illustrates a bacterial filter 60 which may optionally be connected, for example via connection portion 62, between the stem 16 and the patient interface 50. A finger loop 18 or other handle member is preferably provided adjacent the distal end 13 to allow the care giver to support the distal end 13 of the device 10 while also applying the patient interface 50 to the patient.

[0023] The substantially open proximal end 15 of the body 12 is closed by a cap 20 with a planar portion 22 and a rim 24 extending therefrom which extends about an outer surface of the body 12. The cap 20 may be secured to the proximal end 15 of the body 12 in any desired manner, for example but not limited to, threaded connection, friction fit or adhesive bonding. The cap 20 includes a through hole 23 for passage of a piston rod 32 of a plunger assembly 30. A piston 34 is positioned on the distal end of the piston rod 32 and is positioned in the internal chamber 21 of the body 12. The piston 34 seals against the inside surface of the body 12 to define a fluid chamber 31 between the piston 34 and the end wall 14. The proximal end of the piston rod 32 extends externally of the cap 20 and includes a handle 36 or the like to facilitate axial movement of the plunger assembly 30 relative to the body 12 to expel air from or draw air into the fluid chamber 31 through fluid port 17. One or more apertures 25 in the cap 20 allow a balancing flow of air into the internal chamber 21 of the body 12.

[0024] The internal chamber 21 may have any desired volume and in an exemplary

embodiment has a volume of approximately 3 liters which represents the full volume. Preferably the plunger assembly 30 is configured such that the starting position of the piston 34, see Fig. 3, may be adjusted such that a patient specific volume of air may be delivered. In the embodiment of Figs. 3-5, an adjustment ring 38 is positioned about the piston rod 32 and is adjustable therealong. For example, the adjustment ring 38 may be held relative to the piston rod 32 via a friction fit whereby during set up for a particular patient, the ring 38 is pushed to a position along the piston rod 32 which defines the patient specific volume. In Fig. 3, ring 38 is positioned approximately half way along the piston 32 such that in the initial position wherein the ring 38 contacts the cap 20, the volume of the fluid chamber 31 is approximately half the full volume, e.g. 1.5 liters if the full volume is 3 liters. The friction fit would be sufficient to maintain the position of the ring 38 relative to the piston rod 32 during use of the device, but allow the ring 38 to be moved during calibration.

[0025] Alternatively, the adjustment ring may be threadably connected to the piston rod such that rotation of the ring or the rod will cause the ring to move distally or proximally relative to the piston 34. The device 10' in Figs. 6-9 includes a threaded ring 38' and a threaded piston rod 32' .

In the presently illustrated embodiment, the cap 20' includes a stop member 28 on an inside surface thereof such that the position of the ring 38' along the rod 32' may be adjusted without removing the cap 20' . As illustrated in Fig. 7, the stop member 28 and the ring 38' have complementary configurations, for example, octagon, such that the ring 38' may be rotationally held while the piston rod 32' is rotated. To calibrate the plunger assembly 30', the piston rod 32' is moved to until the ring 38' is engaged with the stop member 28 as shown in Fig. 6 and then the rod 32' is rotated until the desired piston position is achieved. Alternatively, the cap 20' could be rotatably secured to the body 12, such that the cap 20' and thereby the ring 38' may be rotated relative to the piston rod 32' which is held stationary.

[0026] Referring again to Fig. 1, the device 10 further includes a positive venting valve 40 and a negative venting valve 42 at the distal end of the body 12. The positive venting valve 40 is a one-way valve configured to allow flow in a direction from the fluid chamber 31 to outside the body 12 and the negative venting valve 42 is a one-way valve configured to allow flow in a direction from outside the body 12 into the fluid chamber 31. While separate one-way valves are described, it is also possible to utilize a single two-way valve which would provide positive and negative venting. The positive venting valve 40 is preferably set such that as the plunger 30 is moved distally, the positive pressure in the fluid chamber 31 is maintained between

approximately 40 to 60 cm H20 and the inhalation flow out of the port 17 is between 3.3 to 10 liters/second. Similarly, the negative venting valve 42 is preferably set such that as the plunger 30 is moved proximally, the negative pressure in the fluid chamber 31 is maintained between approximately 40 to 60 cm H20 and the exhalation flow into the port 17 is between 3.3 to 10 liters/second. These values are preferred ranges and the valves 40, 42 may be otherwise configured. Additionally, the valves 40, 42 may be adjustable such that the pressures and flow rates may be changed for different patients or applications. [0027] Other mechanisms may alternatively or additionally be utilized to control flow rates and pressures. For example, springs or the like (not shown) may be utilized to control the distal movement of the plunger assembly 30, 30' and/or the proximal movement of the plunger assembly 30, 30' . As another example, a linear actuator or the like, may be utilized to control or assist the distal movement of the plunger assembly 30, 30' and/or the proximal movement of the plunger assembly 30, 30' . Other elements, for example, the relative configuration of the piston 34 and the body 12 may further be adjusted to assist control of the flow rates and pressures.

[0028] Once the fluid chamber 31 volume is set and the valves 40, 42 are set to the desired rates, the piston rod 32, 32' is moved proximally until the ring 38, 38' contacts the cap 20, 20' and the device 10, 10' is in a ready to use position as illustrated in Figs. 3 and 6. Fig. 3 illustrates the fluid chamber 31 set to approximately a mid- volume while Fig. 6 illustrates the fluid chamber

31 set to a full volume. To use the device 10, 10', the care giver, or the patient, holds the distal end 13 via the finger loop 18 and applies the patient interface 50 to the patient while the other hand holds the plunger assembly handle 36. The plunger assembly 30 is then moved distally, as indicated by arrows A in Figs. 4 and 8, preferably in consistent motion, such that the piston 34 is driven toward the end wall 14 such that the air in the fluid chamber 31 passes through the port 17, as indicated by arrows B in Figs. 4 and 8, to insufflate the patient's lungs. Once the piston 34 reaches the end wall 14, the user then moves the plunger assembly 30, 30' proximally, as indicated by arrows C in Figs. 5 and 9, preferably in consistent motion, such that the piston 34 is pulled away from the end wall 14 such that the air is drawn into the fluid chamber 31 through the port 17, as indicated by arrows d in Figs. 5 and 9, to exsufflate the patient's lungs. Preferably, the inexsufflation cycle is repeated 4-5 times until all airway debris is expelled and/or the

oxyhemoglobin saturation returns to normal (>94 ). [0029] Modifications of the exemplary components of and uses for the present invention will be apparent to those skilled in the art. The foregoing description of the device should be interpreted as illustrating, rather than as limiting the present invention. All variations and combinations of the features above are intended to be within the scope of the specification.

Claims

What is claimed is:

1. An inexsufflation device comprising:

a hollow body having a substantially closed distal end which defines a fluid port configured to be fluidly connected to a patient interface;

a plunger assembly including a piston positioned in the hollow body and sealingly engaging an inside surface thereof to define a fluid chamber between the piston and the substantially closed distal end, the plunger assembly moveable relative to the hollow body to expel fluid in the fluid chamber through the fluid port or draw fluid into the fluid chamber through the fluid port; and

at least one valve in fluid communication with the fluid chamber and configured to control a maximum positive or negative pressure within the fluid chamber.

2. The inexsufflation device of claim 1, wherein the hollow body has a full volume and the plunger assembly may be adjusted to define a volume of the fluid chamber as a portion of the full volume.

3. The inexsufflation device of claim 2, wherein the full volume is approximately 3 liters.

4. The inexsufflation device of claim 2, wherein the plunger assembly includes a piston rod extending proximally from the piston through a cap on a proximal end of the body, and an adjustment ring is positioned on the piston rod and adjustable in position relative to the piston such that contact of the adjustment ring with the cap defines the fluid chamber volume.

5. The inexsufflation device of claim 4, wherein the adjustment ring has a friction fit relative to the piston rod.

6. The inexsufflation device of claim 4, wherein the adjustment ring is threadably adjustable relative to the piston rod.

7. The inexsufflation device of claim 1, comprising two valves in fluid communication with the fluid chamber, each valve being a one-way valve with one of the valves configured to control a maximum positive pressure within the fluid chamber and the other valve configured to control a maximum negative pressure within the fluid chamber.

8. The inexsufflation device of claim 1, wherein the at least one valve is configured to maintain the maximum positive pressure in the fluid chamber between approximately 40 to 60 cm H20.

9. The inexsufflation device of claim 1, wherein the at least one valve is configured to maintain the maximum negative pressure in the fluid chamber between approximately 40 to 60 cm H20.

10. The inexsufflation device of claim 1, wherein the at least one valve is a two-way valve which is configured to maintain the maximum positive pressure in the fluid chamber between approximately 40 to 60 cm H20 and the maximum negative pressure in the fluid chamber between approximately 40 to 60 cm H20.

11. The inexsufflation device of claim 1, further comprising a handle member extending from the body adjacent the distal end.

12. The inexsufflation device of claim 11, wherein the handle member is a finger loop.

13. The inexsufflation device of claim 1, wherein the fluid port is defined through a stem extending from the substantially closed distal end.

14. An inexsufflation assembly comprising:

a patient interface; and an inexsufflation device including:

a hollow body having a substantially closed distal end which defines a fluid port configured to be fluidly connected to the patient interface;

15. The inexsufflation assembly of claim 14, wherein the patient interface is selected from the group consisting of a facemask, a mouthpiece, a lip seal, and a tracheostomy tube adapter.

16. The inexsufflation assembly of claim 14, wherein an adapter is positioned between the fluid port and the patient interface.

17. The inexsufflation assembly of claim 14, wherein a bacterial filter is positioned between the fluid port and the patient interface.

18. A method of inexsufflating a patient comprising the steps of:

positioning an insufflation assembly such that a patient interface thereof is operably positioned relative to the patient, the insufflation assembly including a hollow body having a substantially closed distal end which defines a fluid port configured to be fluidly connected to the patient interface, and a plunger assembly including a piston positioned in the hollow body and sealingly engaging an inside surface thereof to define a fluid chamber between the piston and the substantially closed distal end;

moving the plunger assembly distally relative to the hollow body to expel fluid in the fluid chamber through the fluid port to insufflate the patient; and

moving the plunger assembly proximally relative to the hollow body to draw fluid into the fluid chamber through the fluid port to exsufflate the patient.

19. The method of claim 18, wherein the inexsufflation device further comprises at least one valve in fluid communication with the fluid chamber and configured to control a maximum positive or negative pressure within the fluid chamber.

20. The method of claim 19, wherein the at least one valve is configured to maintain the maximum positive pressure in the fluid chamber between approximately 40 to 60 cm H20 and/or the maximum negative pressure in the fluid chamber between approximately 40 to 60 cm H20.