# Patent

## Title
Inverted balloon system and inflation management system

## Abstract

At least one exemplary embodiment is directed to an earpiece having a balloon and a stent where the balloon is mounted on the stent and the stent incorporates two or more channels including at least an inflation channel and an acoustic channel. In some embodiments the stent is configured to pass audio signals through the acoustic channel where the acoustic channel is independent of the inflation channel of the balloon. Other embodiments are disclosed.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 12/578,461 filed on 13 Oct. 2009 and further claims the benefit of U.S. provisional patent application No. 61/103,923 filed 10 Oct. 2008. The disclosures of the aforementioned applications are incorporated herein by reference in their entirety.


FIELD
The embodiments relate in general to pressure management and balloon bonds, and particularly though not exclusively, is related to creating a pressure management system for earpiece systems.
BACKGROUND
Inflatable acoustic systems using balloons can have difficulties in maintaining the bonding of a balloon to a stent upon insertion. In addition there is no pressure management system that has been designed for an inflatable earpiece.
SUMMARY
At least one exemplary embodiment is directed to a method of invert bonding of a balloon comprising: bonding a sheath balloon to a stent at a first bond location, where the sheath balloon has first surface and a second surface, where the bonding at the first bond location is between the stent and a portion of the first surface, where the first surface faces the stent; pulling the sheath balloon from an unbounded end over the first bond to a chosen second bond location so that the first surface faces away from the stent forming an inverted bond at the first bond location; and bonding the sheath at the second bond location where the bonding at the second bond location is between the stent and a portion of the second surface.
At least one exemplary embodiment is directed to a method of forming an inverted bond balloon comprising: aligning a mold core with a first and a second mold shell, where the first shell has an injection port, where the first and second mold shell and the mold core are aligned using alignment recesses and pins, where when the mold core is aligned there is a gap between a portion of the mold core and the first and second mold shells, where the gap is designed to be related to a molded balloon thickness; aligning the injection port with an injection nozzle; clamping a mold against an injection nozzle; inserting a flexible material into the mold through the injection port of the mold; removing the mold from the injection nozzle; curing the material in the mold, where curing can be at least one of cooling, UV illumination, and chemical reaction; and opening the mold and removing a molded balloon with at least one inverted bond, where the molded balloon is configured so that when attached to a stent and inflated the inverted bond presses against a stent.
At least one exemplary embodiment is directed to an inverted bond balloon stent comprising: a balloon bonded to a stent, where the balloon has at least one end of the balloon inverted bonded to the stent; and a stent, where the stent is configured to provide one of air and liquid to the balloon.
At least one exemplary embodiment is directed to a pressure management system for an earpiece comprising: a first valve, where the first valve allows air to pass from a first side of the valve to a second side more readily than from the second side to the first side; an inflation channel, where the inflation channel has an outer diameter less than 5 mm; a pressure release mechanism; a pump; a stent, where the inflation channel is embedded; and a balloon, where the first valve, the inflation channel, the pressure release mechanism, the pump, and the balloon are operatively connected, where the first valve is positioned so that air from the pump passes through the first valve to inflate the balloon and where the leak rate of the air from the balloon back to the pump is less than 1% by volume per minute and where the pressure release mechanism is configured to release pressure from the balloon to the environment upon actuation, and where the pressure management system is configured to manage the inflation pressure of the balloon in an orifice.



BRIEF DESCRIPTION OF THE DRAWINGS
Exemplary embodiments herein will become more fully understood from the detailed description and the accompanying drawings, wherein:
FIGS. 1 through 4 illustrate a method of bonding a balloon sheath to a stent to form an inverted bond in accordance with at least one exemplary embodiment;
FIG. 5 illustrates an inflated balloon having an inverted bond in accordance with at least one exemplary embodiment.
FIG. 6 illustrates the restoring force associated with an inverted bond of a balloon in accordance with at least one exemplary embodiment;
FIG. 7 illustrates a core mold associated with the molding of a balloon with an inverted bond in accordance with at least one exemplary embodiment;
FIG. 8 illustrates the core mold inserted into one shell mold in accordance with at least one exemplary embodiment;
FIG. 9 illustrates a core mold inserted into two shell molds in accordance with at least one exemplary embodiment;
FIG. 10 illustrates a pressure management system also referred to as an inflation management system (IMS) in accordance with at least one exemplary embodiment;
FIG. 11 illustrates a block diagram of an IMS system using a manual pump in accordance with at least one exemplary embodiment;
FIG. 12 illustrates a block diagram of an IMS system using a automated pump in accordance with at least one exemplary embodiment; and
FIG. 13 illustrates a diagram of an restoring membrane based IMS in accordance with at least one exemplary embodiment.



DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
The following description of exemplary embodiment(s) is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.
Processes, techniques, apparatus, and materials as known by one of ordinary skill in the art may not be discussed in detail but are intended to be part of the enabling description where appropriate. For example specific computer code may not be listed for achieving each of the steps discussed, however one of ordinary skill would be able, without undo experimentation, to write such code given the enabling disclosure herein. Such code is intended to fall within the scope of at least one exemplary embodiment.
Additionally, the sizes of structures used in exemplary embodiments are not limited by any discussion herein (e.g., the sizes of structures can be macro (centimeter, meter, and size), micro (micro meter), nanometer size and smaller).
Notice that similar reference numerals and letters refer to similar items in the following figures, and thus once an item is defined in one figure, it may not be discussed or further defined in the following figures.
In all of the examples illustrated and discussed herein, any specific values, should be interpreted to be illustrative only and non-limiting. Thus, other examples of the exemplary embodiments could have different values.
Additionally various materials can be used for inflations channels, stents, acoustic channels, valves, balloons and pressure release mechanism. For example for examples for the stent, valves, inflation channels, and balloons a material that has a low permeability to the medium in the balloon can be used. For example Teflon can be used for an air medium. The type of material will be governed by the design criteria. For example a flexible material that has an air permeability of less than 5% loss of volume in 6 hours is SARLINKTM.
FIGS. 1 through 4 illustrate a method of bonding a balloon sheath to a stent to form an inverted bond in accordance with at least one exemplary embodiment. At least one exemplary embodiment is directed to a method of invert bonding of a balloon comprising: bonding a sheath balloon 110 (e.g., of SARLINKTM or other materials that have a low permeability to the medium (air and liquid) in the balloon) to a stent (e.g., which can be made of the same material as the balloon and which can also have a low permeability (e.g., loss of medium by volume is less than 3% in a 16 hour period) at a first bond location 120 (e.g., at the stent tip and extending inward a distance for example about 1 mm), where the sheath balloon has first surface and a second surface, where the bonding (e.g., adhesive bonding, thermal bonding, UV curing bonding, or molding the balloon and stent as one piece) at the first bond location is between the stent and a portion of the first surface, where the first surface faces the stent (FIGS. 1 and 2, where the stent 100 can have an acoustic channel 105); pulling (e.g., pulling from A in the direction of 130) the sheath balloon from an unbounded end over the first bond (from A to B, FIGS. 3 and 4) to a chosen second bond location (B) (FIG. 3) so that the first surface faces away from the stent forming an inverted bond at the first bond location; and bonding the sheath at the second bond location where the bonding (170, FIG. 5) at the second bond location is between the stent and a portion of the second surface.
Note the bond strengths are such that various balloon pressures can be maintained. For example an internal gauge pressure between 0.05 bar to 3 bar. FIG. 5 illustrates an inflated balloon 120, expanded in accordance to at least one exemplary embodiment. Note that the tip is nearly obscured (the forward portion of the inflated balloon can vary in length, it can extent completely over (e.g. align with the tip or extent over several mms) the tip (through which 105 is shown) to recessed (e.g., 1 mm from the tip) in the radial direction from the expanding balloon.
FIG. 6 illustrates how an inflated balloon with an inverted bond has the pressure presses the bond (e.g., 620) to the stent rather than try and separate the balloon from the stent as the exterior pressure (610) would do if there were not an inverted bond. This allows some force to be exerted along and/or radial to the stent on the balloon 120. Note in FIG. 6 only one inverted bond is shown (e.g., bond 170 is not an inverted bond), however at least one exemplary embodiment has bond 170 also replaced with an inverted bond, in such a situation the sheath would be moved from B to A slightly and the B end flipped to form an inverted bond.
In addition to bonding a sheath balloon on a stent to form an inverted bond, an inverted bond can be molded (see FIGS. 7, 8, and 9).
FIGS. 7, 8, and 9 illustrate a mold that can be used in a method of forming an inverted bond balloon. For example at least one exemplary embodiment if directed to a method of molding a balloon with an inverted bond comprising: aligning a mold core with a first and a second mold shell (750, 790), where the first shell has an injection port (760), where the first and second mold shell and the mold core are aligned using alignment recesses (710, 720) and pins (710A, 720A), where when the mold core is aligned there is a gap between a portion of the mold core and the first and second mold shells, where the gap (730) is designed to be related to a molded balloon thickness (e.g., 0.1 mm); aligning the injection port 760 with an injection nozzle; clamping a mold against an injection nozzle; inserting a flexible material into the mold through the injection port of the mold; removing the mold from the injection nozzle; curing the material in the mold, where curing can be at least one of cooling, UV illumination, and chemical reaction; and opening the mold and removing a molded balloon with at least one inverted bond, where the molded balloon is configured so that when attached to a stent and inflated the inverted bond presses against a stent.
Note that the gap 730 can be variable throughout the mold allowing one to mold variable thickness balloons. For example a region of the balloon that one would want to expand first can be thinner than another part of the balloon. Note that the material that can be used for molding can (besides satisfying the design permeability requirement set during design) be flexible. Note that the flexible material can have a linear elongation of greater than 100% without deformation of more than 5% in the area of the balloon when deflated. Some sample materials are SARLINKTM.
Note that the stent can be connected to microphones, where some can sample the ambient environment (ASM 1150), some sampling the ear canal (ECM, 1170) and receivers, some playing acoustic energy into the ear canal (ECR 1160). Note various microphones and receivers can be used, for example Knowles MEM microphones, TO and FG microphones, and TWFK receivers.
FIGS. 10 through 13 illustrate inflation management systems (also referred to as pressure management systems) in accordance with at least a few exemplary embodiments. For example at least one exemplary embodiment is directed to a pressure management system (e.g., 1090, 1100, 1200) for an earpiece (e.g., a device that is designed to be used with any part of the ear) comprising: a first valve (e.g., duck valves, one way valves, . . . 1030, 1130A-1130F), where the first valve allows air to pass from a first side of the valve to a second side more readily than from the second side to the first side; an inflation channel, where the inflation channel has an outer diameter less than the size of an orifice in which it is to be inserted (e.g., <5 mm); a pressure release mechanism (e.g., a pin to push open the valve 1030); a pump (e.g., a manual pump (e.g., bladder), automatic pump (e.g., linear actuator) a stent, where the inflation channel is embedded; and a balloon, where the first valve, the inflation channel, the pressure release mechanism, the pump, and the balloon are operatively connected, where the first valve is positioned so that air from the pump passes through the first valve to inflate the balloon and where the leak rate of the air from the balloon back to the pump is less than 1% by volume per minute and where the pressure release mechanism is configured to release pressure from the balloon to the environment upon actuation, and where the pressure management system is configured to manage the inflation pressure of the balloon in an orifice.
Note that the stent can be as large as the inflation tube or larger.
Note that at least one exemplary embodiment can include a second valve to release pressure when the pressure in the balloon exceeds a design threshold (e.g., between 0.05 bar gauge to 3 bar gauge).
Note also that FIGS. 11 and 12 illustrate detachable stents and balloon systems (ear manifold 1120) from eth remaining elements (instrument package 1111). A valve in the stent 1130C can allow the one way passage of medium into the balloon (e.g., inflation element 1180). A second valve 1130D can release pressure if it gets above a certain value. For example if the gauge pressure exceeds 0.25 bar gauge. Note that the pump can also be connected to a release valve 1130F. For an automated pump a power source 1210 (e.g. battery) can power the pump 1130.
FIG. 13 illustrates a restoring membrane exemplary embodiment, where an inflated balloon 1330, when pressed (e.g., via ear canal wall) exerts pressure on a restoring membrane 1320. The restoring membrane can provide a restoring force 1310A, which is felt by the balloon 1310B so that when the balloon is no longer pressed it will expand back to an equilibrium position. The restoring membrane can be one that has a higher elastic elongation than the balloon material, or be thinner. The restoring membrane and balloon can be pneumatically coupled 1350 through the stent 100.
Note that an earpiece can include an Ambient Sound Microphone (ASM) to capture ambient sound, an Ear Canal Receiver (ECR) to deliver audio to an ear canal and an Ear Canal Microphone (ECM) to capture and assess a sound exposure level within the ear canal. The earpiece can partially or fully occlude the ear canal to provide various degrees of acoustic isolation. In at least one exemplary embodiment, assembly is designed to be inserted into the user's ear canal, and to form an acoustic seal with the walls of the ear canal at a location between the entrance to the ear canal and the tympanic membrane (or ear drum). In general, such a seal is typically achieved by means of the balloon.
While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

## Claims

1. An earpiece, comprising:
a balloon; and
a stent, wherein the balloon is mounted on the stent and the stent incorporates two or more channels including at least an inflation channel and an acoustic channel, where the stent is configured to pass audio signals through the acoustic channel that is independent of the inflation channel of the balloon;
wherein the balloon comprises a sheath balloon having a first surface and a second surface, wherein a bond exists at a first bond location between the stent and a portion of the first surface, where the first surface faces the stent and wherein the sheath balloon is pulled from an unbounded end over the first bond to a chosen second bond location so that the first surface faces away from the stent forming an inverted bond at the first bond location, and a second bond location where a bonding at the second bond location is between the stent and a portion of the second surface.

2. The earpiece of claim 1, wherein the acoustic channel is coupled to at least one of a microphone or a receiver at one end of the acoustic channel.

3. The earpiece of claim 1, wherein the stent is configured to provide or carry one of air or liquid to and from the balloon.

4. The earpiece according to claim 1, where the stent is configured to provide or carry air or fluids to and from the balloon via the inflation channel that is pneumatically coupled to the balloon.

5. The earpiece according to claim 1, wherein the acoustic channel is connected at one end to a microphone.

6. The earpiece according to claim 1, wherein the acoustic channel is connected at one end to a receiver.

7. The earpiece of claim 1, wherein the stent passes through the balloon.

8. The earpiece according to claim 1, further comprising a pressure management system for the earpiece.

9. The earpiece according to claim 8, wherein the pressure management system comprises:
a first valve, where the first valve allows air to pass from a first side of the valve to a second side more readily than from the second side to the first side;
the inflation channel, wherein the inflation channel is embedded; and
the balloon.

10. The earpiece according to claim 9, wherein the pressure management system further comprises a pressure release mechanism, a pump, and the stent.

11. The earpiece of claim 10, wherein the first valve, the inflation channel, the pressure release mechanism, the pump, and the balloon are operatively connected, where the first valve is positioned so that air from the pump passes through the first valve to inflate the balloon.

12. The earpiece of claim 11, where the leak rate of the air from the balloon back to the pump is less than 1% by volume per minute and where the pressure release mechanism is configured to release pressure from the balloon to the environment upon actuation, and where the pressure management system is configured to manage the inflation pressure of the balloon in an orifice.

13. The earpiece according to claim 12, where the inflation channel is in the stent, inflation channel inner diameter is less than 2 mm, and where the stent outer diameter is less than about 4 mm.

14. The earpiece according to claim 13, further comprising a second valve, where the second valve is configured to release pressure when the balloon pressure exceeds a threshold pressure value.

15. The earpiece according to claim 14, where the threshold value is in the range of about 0.15 bar gauge pressure to 0.30 bar gauge pressure.

16. The earpiece according to claim 14, where the pressure in the balloon upon detachment from another element of the pressure management system maintains its pressure by use of at least a third valve operatively connected to the stent.

17. The earpiece according to claim 10, where the pump is at least one of a manual pump and an automatic pump.

18. The earpiece according to claim 9, where the stent and balloon are detachable from the remaining elements of the pressure management system.

19. A closed pressure management system, comprising:
a balloon;
a restoring membrane; and
a stent having an inflation channel of the balloon and an acoustic channel, where the stent is configured to pass audio signals through the acoustic channel that is independent of the inflation channel of the balloon and where the balloon and restoring membrane are pneumatically coupled so that when the balloon is inflated and depressed the restoring membrane will expand supplying a restoring force to counter the depression, and where the balloon, stent and restoring membrane are operatively and pneumatically coupled in a closed system;
wherein the balloon comprises a sheath balloon having a first surface and a second surface, wherein a bond exists at a first bond location between the stent and a portion of the first surface, where the first surface faces the stent and wherein the sheath balloon is pulled from an unbounded end over the first bond to a chosen second bond location so that the first surface faces away from the stent forming an inverted bond at the first bond location, and a second bond location where a bonding at the second bond location is between the stent and a portion of the second surface.