Patent Description:
Inflation syringes and catheter technologies have become increasingly important in the interventional radiology and cardiology medical fields. Balloon- tipped catheter systems and inflation syringe apparatus have been utilized in various fields of medicine, such as urology, gynecology, cardiology and others. One area in which balloon-tipped catheter systems and their associated syringe systems have resulted in significant improvement over traditional treatment methods is in connection with the treatment of coronary artery disease.

Coronary artery disease and the associated narrowing of the arteries that feed oxygen-rich blood to the heart (a condition known as "stenosis") is one of the conditions for which balloon-tipped catheters are often utilized as a method of treatment. Traditionally, coronary artery blockages were treated with medicine or by performing coronary artery by-pass surgery. Various kinds of medication could be administered which would decrease the work of the heart by slowing the heart rate, dilating the blood vessels, or lowering blood pressure. However, such medicinal treatments did not cure coronary artery narrowing. As a result, not only would the arterial narrowing remain, but it would also continue to present a risk that at some point the narrowing would become serious enough to require surgical intervention.

In coronary artery by-pass surgery, a blood vessel from the chest or leg is grafted beyond the point of blockage so that the blood detours past the blockage in order to reach the heart. In some severe cases, multiple by-passes are performed. As is well known, coronary artery by-pass surgery is an expensive, highly invasive procedure which often requires prolonged hospitalization and recovery periods.

In the last several years, another method for treating coronary artery disease has developed, called balloon coronary angioplasty, or more technically, percutaneous transluminal coronary angioplasty (PTCA). PTCA is a much less traumatic procedure than coronary artery by-pass surgery. PTCA takes about two hours to perform and can be conducted under local anesthesia. PTCA has significantly improved patient recovery times allowing patients to resume normal activities in a matter of days. Because PTCA is much less expensive and less traumatic than by-pass surgery while still providing effective blockage removal, PTCA has experienced a dramatic increase in the number of such procedures performed each year.

To perform a typical PTCA procedure, an introducer sheath is inserted through an incision made in the groin of the patient or in the artery of an arm of the patient. An x-ray sensitive dye is injected into the coronary artery through a catheter that is introduced through the sheath. The dye enables the doctor, through the use of real-time x-ray technology, to clearly view the patient's vasculature on a television monitor and to thereby locate the blockage. A balloon-tipped catheter is advanced through the vasculature to the point of the blockage with the help of the x-ray monitor.

Due to the increase in the number of PTCA procedures being performed, there has been a substantial increase in the use of electronically monitored inflation syringe systems which are utilized to inflate the balloon catheter or other inflatable balloon-type device during PTCA procedures. Typical syringe systems comprise a barrel and a plunger which are selectively operable to increase fluid pressure applied to the balloon catheter and to remove the applied pressure to the balloon catheter once the procedure is finished. The syringe systems are adapted to provide user readable feedback to the practitioner in the form of a numeric value allowing the practitioner to assess the amount of pressurization that is being applied to the balloon. This allows the practitioner to closely monitor pressurization values to provide a more controlled and systematic inflation of the balloon during the procedure.

Many of the apparatus utilized in PTCA procedures are inexpensive devices which can be discarded after a single use. Disposable devices eliminate expensive and time consuming sterilization procedures which are necessary for reusable devices. Moreover, disposable devices eliminate the risk of transmission of diseases between patients. Consequently designers and manufacturers of inflation syringes have worked to limit the expense of such disposable inflation syringes to make them more costeffective for a wide variety of applications. As a result, there has been an emphasis in favor simpler designs over more complex apparatus. Such designs typically comprise a simple digital or analog readout of the inflation pressure on the display provided in connection with the inflation syringes.

One typical display of electronically monitored syringes comprises a <NUM>- segment LED display having three to five fields, and perhaps a decimal point. Such simplistic displays are limited in the information they can convey. Some displays provide only the current pressurization of the syringe. Higher-end models may allow the user to toggle the display to view additional information. Although the ability to view additional information can be useful, the user is required to expend mental effort and time to access the additional information, interpret the relevance of the data, and determine how the different values interrelate. Still more expensive syringes may have multiple <NUM>-segment LED displays so as to display multiple values simultaneously. Yet, even with multiple values displayed, a user expends time and mental effort to interpret and relate the values, and to remember which displays represent given values.

<CIT> discloses a pressure gauge for displaying the magnitude of fluid pressure generated within a syringe or another pressurized system. The pressure gauge is removably attachable to a syringe. A piezoresistive transducer senses fluid pressure and generates an electrical signal that changes in response to changes in said fluid pressure. The electrical signal is converted to digital signals by a microprocessor. A stepper motor responds to the digital signals to control a pointer that moves across a dial to display the magnitude of the fluid pressure.

<CIT> discloses an electronically controlled syringe system for connection to a balloon catheter or other balloon-type member and for automatically monitoring, displaying and recording inflation data when the syringe system is used to inflate the balloon catheter or other balloon-type member. The controller is programmable to permit optional selection and input of various control parameters, such as a maximum positive inflation pressure that is to be applied, maximum duration for applying positive inflation pressure, initialization of the date and time of an inflation procedure and/or retrieving and displaying inflation data previously recorded for any prior inflation of the balloon catheter or other balloon member.

<CIT> discloses a syringe apparatus for use with balloon-tipped catheters having a pressure gauge and timer assembly. In one mode, the timer assembly displays the duration of a current event of inflation or deflation, and the duration of the most recent past event of inflation or deflation. In another mode, the timer assembly displays historical information showing the event number and duration of past events of inflation and deflation.

<CIT> discloses a fluid delivery device for delivering fluid to a target site such as an intervertebral disc during discography. The fluid delivery device includes pressure and volume sensors to determine the pressure and the volume of the fluid delivered to the intervertebral disc.

<CIT> relates to inflation devices used in medical procedures, and more particularly, to inflation control systems suitable for controlling the inflation and deflation of balloons or other inflatable devices used in medical procedures, such as balloon catheters used in angioplasty procedures.

<CIT> relates generally to a medical device, and more particularly to an apparatus for sensing and qualitatively outputting data associated with the inflation of an expandable member when deployed in interior body regions of humans or other animals.

The present invention relates to a modularized component assembly including an inflation syringe having an improved display. More particularly, the present invention relates to methods and apparatus for providing both numeric and non- numeric indications of an inflation pressurization associated with the inflation syringe. According to one embodiment of the present invention, a progressive illuminated non-numeric display is provided for displaying the pressurization of the inflation syringe along with numeric indicators of the pressurization.

In a first aspect, the invention provides a modularized component assembly including an inflation syringe according to claim <NUM>.

In a second aspect, the invention provides a method of assembling a modularized component assembly of the invention according to claim <NUM>.

According to one aspect of the present invention, the progressive display includes a plurality of indicia corresponding to a range of inflation pressurization values. The indicia are illuminated to exhibit a given pressurization in a clear and intuitive manner that allows the practitioner to: (<NUM>) easily monitor the general intensity of the pressurization; (<NUM>) intuitively track changes in the pressurization; and (<NUM>) simply observe the relationship of multiple pressurization values without needing to rely solely on more time consuming and less intuitive interpretation of numeric displays. This permits the user to ascertain the relationship between the current pressurization, desired pressurization amounts, and the rate of pressurization in a straightforward and helpful manner.

According to one aspect of the present invention, the display includes a numeric display for representing the pressurization as a numeric value in addition to the non-numeric display. This provides an additional indication of the inflation pressurization that complements the visual indication provided by the non-numeric display. By providing the numeric display and the associated numeric value of the pressurization, a user can identify more minute incremental changes to pressurization and can easily ascertain the precise numeric value of a given pressurization.

Also disclosed herein is a method of displaying non-numeric indicia representing inflation pressurization. In the method, a plurality of indicia are provided to signal changes in the inflation pressurization. Once an initial pressurization is indicated, the current pressurization and changes in pressurization can be displayed to the user in a simple and intuitive manner. For example, one or more of the indicia can be illuminated as an indication of the current pressurization. In response to a change in the pressurization, a different one of the indicia is actuated to represent the change in pressurization.

The user interface provides one or more desired types of additional data such as a last maximum pressurization value. For example, one or more of the indicia are identified as an indicator of a representative pressurization such as a last maximum pressurization. Once a representative pressurization is indicated by illuminating a non-numeric indicia corresponding to such representative pressurization and/or providing a blinking numeric indication of such representative pressurization, the current pressurization and changes in pressurization are displayed to the user in a simple and intuitive manner. For example, once the representative pressurization is indicated, one or more of the indicia can then be actuated as a representation of the current pressurization. In response to a change in the pressurization, a different one of the indicia is actuated to represent the change in pressurization. In one embodiment, the non-numeric indicia of current and representative pressurization values can be shown together allowing the user to simply and intuitively determine the relationship between the two values.

According to one aspect of the present invention, an improved modularized component assembly system, method and process for testing and assembly of the inflation device apparatus is provided. The modularized component assembly enables each component of the inflation device to be tested while also enabling the components to be tested once they have been assembled together. The ability to test individual components and assembled components greatly reduces or altogether eliminates the disposal of functional components or even an entire inflation syringe when a single component of the device is defective. This allows the manufacturer to test individual components to separately to assess their viability. As a result, defective components can be readily identified before they are assembled with other components into a functional inflation syringe.

These and other objects and features of the present disclosure will become more fully apparent from the following description and appended claims.

In order to describe the manner in which the above recited and other advantages and features of the invention may be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in accompanying drawings.

The present invention relates to an inflation syringe having an improved display and modularized component assembly. More particularly, the present invention relates to methods of assembling
and apparatus for providing both numeric and non- numeric indications of inflation pressurization associated with the inflation syringe. According to one embodiment, a progressive non-numeric display is provided for displaying the pressurization of the inflation syringe along with numeric indicators of the pressurization. The progressive display includes a plurality of indicia corresponding to a range of inflation pressurization values. The indicia are illuminated to display a given
pressurization and to allow the practitioner to not only easily monitor the general intensity of the pressurization but also to monitor changes in the pressurization without needing to interpret numerical values. This permits the user to quickly ascertain the relationship between the current pressurization, the desired pressurization, and the rate of pressurization.

According to one aspect of the present disclosure, the progressive display includes a numeric display for representing the pressurization as a numeric value. This provides an additional, precise indication of the inflation pressurization that complements the visual indication provided by the non-numeric indicia. According to another aspect of the present invention, a user interface is provided allowing the user to input information that can be used to automatically identify a target pressurization or a last maximum pressurization value. The user interface may also allow the user to select other parameters to be displayed.

A displaying of a pressurization is also provided according to one aspect of the present invention. In the displaying a plurality of indicia adapted to signal changes in the inflation pressurization are provided. One or more of the indicia are identified as an indicator of a desired pressurization such as a last maximum pressurization. Once a desired pressurization is selected, the inflation pressurization is monitored. One or more of the indicia are illuminated as an indication of the pressurization. In response to a change in the pressurization, a different one of the indicia is illuminated.

An improved modularized component assembly system, and method and process for improving testing, assembly and the cost of the inflation device apparatus, are also provided according to one aspect of the present disclosure. In the method, the components are obtained and then each functional component is tested separately. Once the components have been tested separately, the components are assembled. Consequently, in the event that a single component is defective only the defective component will be discarded, rather than an entire inflation device.

<FIG> illustrates an inflation syringe <NUM> according to one embodiment of the present invention. Inflation syringe <NUM> comprises a barrel <NUM>, a plunger <NUM> and a display <NUM>. Barrel <NUM> includes an inner lumen which is adapted to hold a pressure transducing medium such as saline or another fluid. Plunger <NUM> is adapted to increase or decrease the pressurization within barrel <NUM>. Display <NUM> displays the pressurization information to the user in a simple and intuitive manner.

In the illustrated embodiment, barrel <NUM> is substantially tubular in configuration. A syringe plunger <NUM> is configured to be slidably mounted within barrel <NUM>. Plunger <NUM> includes a threaded portion <NUM> which is configured to mate with corresponding threads of a plunger retaining nut <NUM>. Plunger retaining nut <NUM> secures plunger <NUM> within barrel <NUM>. Tubing <NUM> is coupled to barrel <NUM> at one end, and to a rotatable luer coupler <NUM> at an opposite end. Rotatable luer coupler <NUM> is adapted to connect tubing <NUM> to a balloon catheter (not depicted) or another inflatable medical device.

The proximal end of plunger <NUM> is positioned within the interior of barrel <NUM> in a fluid-tight manner such that advancing plunger <NUM> into barrel <NUM> creates positive pressure within barrel <NUM>. The distal end of plunger <NUM> comprises a handle <NUM> which enables a user to apply pressure to push plunger <NUM> further into barrel <NUM> or to withdraw plunger <NUM> from barrel <NUM>. The positive pressure exerted on the fluid contained within barrel <NUM> is applied to a balloon catheter through tubing <NUM>. Tubing <NUM> is connected to the balloon catheter by means of a rotatable luer coupler <NUM>. Similarly, by withdrawing plunger <NUM> toward the rear of the barrel <NUM>, the positive pressure exerted on the balloon catheter may be decreased. According to one embodiment of the present invention, the process of pressurizing barrel <NUM> to a desired pressurization and then depressurizing barrel <NUM> can be considered an inflation routine.

In the illustrated embodiment, a display <NUM> is mounted to the exterior of barrel <NUM>. Display <NUM> provides an intuitive and easy to read configuration. In the illustrated embodiment, display <NUM> includes a numeric display <NUM>, non-numeric display <NUM>, and a timer display module <NUM>. By providing both a numeric display <NUM> and non-numeric display <NUM>, display <NUM> allows a user to read and understand a wider variety of information than provided by existing displays. Additionally, display <NUM> provides pressurization information in a helpful and intuitive manner eliminating the time and mental effort required for a user to interpret the output of existing displays. In this manner, a practitioner can focus on other aspects of the procedure to be performed without needing to focus on interpreting individual numeric or other information provided by existing displays.

In the illustrated embodiment, display <NUM> is coupled to a pressure sensing apparatus such as a pressure transducer. The pressure sensing apparatus may be integrated within the wall of barrel <NUM>, mounted within barrel <NUM>, positioned in fluid communication with the interior of barrel <NUM>, or otherwise configured to detect the pressure inside barrel <NUM>. As used to describe the relationship of the pressure sensing apparatus and the interior of barrel <NUM>, the term "fluid communication" may include pneumatic or hydraulic transmission (direct or indirect) of fluid pressures exerted within barrel <NUM> and tubing <NUM> to the pressure sensing apparatus so that such fluid pressures can be sensed by the pressure sensing apparatus. Direct transmission of such fluid pressures can be provided, for example, by means of a diaphragm of a piezoresistive semiconductor transducer which is placed into contact either pneumatically or hydraulically, or a combination of both) with a fluid contained in a closed system. Indirect transmission can occur, for example, where the transducer means is coupled to a diaphragm that in turn contacts the fluid contained in a closed system.

The pressure sensing apparatus may be coupled to display <NUM> on the exterior of barrel <NUM> so as to communicate pressurization information associated with the interior of barrel <NUM>. In another embodiment, the pressure sensing apparatus may be integrated with display <NUM> and in fluid communication with the interior of barrel <NUM>, so as to detect pressurization within barrel <NUM>. In one embodiment, a pressure sensing apparatus is located at the end of connecting tubing attached through a T-connector to tubing <NUM>. Alternatively, the pressure sensing apparatus can be mounted as part of the electronic circuitry contained inside of display <NUM>. In yet another embodiment, the pressure sensing apparatus is located at another position remote from the barrel <NUM>. The pressure sensing apparatus can comprise a piezoresistive semiconductor type transducer. In still another embodiment the pressure sensing apparatus may comprise transducer apparatus other than a piezoresistive or semiconductor apparatus. For example, in one embodiment the pressure sensing apparatus comprises a conventional strain gauge transducer, which has been known and used in the art for many kinds of different pressure monitoring applications, or fibreoptic transducers.

As will be appreciated by those skilled in the art, a variety of types and definitions of inflation routines can be utilized without limiting the scope of the invention. By way of example, and not by limitation, an inflation routine may begin when pressurization of barrel <NUM> begins, and can include several instances of advancing plunger <NUM> within barrel <NUM> and retracting plunger <NUM> from barrel <NUM>. The inflation routine may end when all pressure is released from barrel <NUM>. In another exemplary embodiment, an inflation routine may begin when positive pressurization is exerted within barrel <NUM> and ends at the conclusion of a first period of depressurization of the barrel. In one embodiment, not all of the pressurization may be released from barrel <NUM> at the end of the first period of depressurization. Thus, if not all pressure is released from barrel <NUM>, the next inflation routine may begin when an increase in pressurization is again detected, even where the pressurization is at a lower value than the maximum pressurization value of the previous inflation routine. Additionally, an inflation routine may be utilized with a pressurization mechanism other than an inflation syringe.

As will be appreciated by those skilled in the art, the function of inflation syringe <NUM> can be provided by a variety of syringe or pressurization systems. In one embodiment, a pump device that is pressurized by a plunger or similarly functioning component that is actuated multiple times, and that releases the pressure through a valve is utilized instead of a barrel and plunger syringe system. In another embodiment an automatic pressurization device may provide the required pressure to a tubing and the pressure in the tubing may be detected and monitored. A more complete description of one embodiment of such syringe system is contained in <CIT>.

<FIG> is an exploded view of inflation syringe <NUM> of <FIG> , illustrating the components of inflation syringe <NUM> and the modularized component assembly of inflation syringe <NUM>. In the illustrated embodiment, plunger <NUM> and handle <NUM> are shown separately from barrel <NUM>. Plunger <NUM> comprises a proximal end <NUM>, a rubber tip <NUM> and threads <NUM>. The distal end of plunger <NUM> includes a handle receiving component <NUM> and a spring-activated trigger <NUM>.

In the illustrated embodiment, rubber tip <NUM> is positioned at proximal end <NUM> of plunger <NUM>. Rubber tip <NUM> is adapted to engage the interior of barrel <NUM> in a fluid-tight manner to allow the user to increase the pressurization on fluid positioned within barrel <NUM>. As the user advances plunger <NUM> further into barrel <NUM>, rubber tip <NUM> is also advanced to increase the positive pressure within barrel <NUM>. Similarly, the user can retract plunger <NUM> in a rearward direction within barrel <NUM> to decrease the pressurization within barrel <NUM>.

In the illustrated embodiment, plunger <NUM> is secured within barrel <NUM> by plunger retaining nut <NUM>. The configuration of retaining nut <NUM> allows a user to secure plunger <NUM> within barrel <NUM> by threadably coupling retaining nut <NUM> to barrel securement threads <NUM>. The configuration of retaining nut <NUM> secures plunger <NUM> within barrel <NUM> while allowing for slidable movement of plunger <NUM> in forward and rearward directions within barrel <NUM>. In the illustrated embodiment, barrel securement threads <NUM> are adapted to cooperatively engage one or more additional components of inflation syringe <NUM>. For example, barrel securement threads <NUM> can be adapted to mate with a second set of corresponding threads integrated within plunger retaining nut <NUM>.

The distal end of plunger <NUM> includes a handle receiving component <NUM> which is configured to accept and engage a spring-activated trigger <NUM>. In the illustrated embodiment, a user can advance syringe plunger <NUM> without engagement of threads <NUM> by actuating spring-activated trigger <NUM>. When the user actuates spring-activated trigger <NUM>, a portion of trigger <NUM> is retracted into handle receiving component <NUM>. Retracting spring activated trigger <NUM> into handle receiving component <NUM> disengages threads <NUM> from the corresponding threads of plunger retaining nut <NUM>. As a result, plunger <NUM> can freely slide in either a proximal direction or distal direction within barrel <NUM>. By releasing the compression on trigger <NUM> relative to handle receiving component <NUM>, the threads <NUM> are then permitted to engage the corresponding threads of plunger retaining nut <NUM>. Engagement between threads <NUM> and plunger retaining nut <NUM> allows plunger <NUM> to be advanced or retracted by screwing plunger <NUM> either in a clockwise or counter clockwise direction respectively.

Trigger <NUM> allows the user to rapidly provide an increase or decrease of pressurization within barrel <NUM> of inflation syringe <NUM>. In other words, a user can compress trigger <NUM> against handle receiving component <NUM> and threadlessly advance or retract plunger <NUM> within barrel <NUM> to increase or decrease the pressurization within barrel <NUM>. The user can then release trigger <NUM> and threadably advance or retract plunger <NUM> within barrel <NUM> to provide a more gradual adjustment of plunger <NUM> to a more exacting desired pressurization. Additionally, threadably advancing plunger <NUM> within barrel <NUM> can be utilized to provide greater pressurization within barrel <NUM> than can be accomplished by threadless advancement alone.

In the illustrated embodiment, the body of syringe barrel <NUM> includes a mounting bracket <NUM>. Mounting bracket <NUM> provides a mechanism for securing display <NUM> to syringe barrel <NUM>. Mounting bracket <NUM> is integrally coupled to the proximal, or leading end, of barrel <NUM>. In the illustrated embodiment, mounting bracket <NUM> is in fluid communication with the interior of barrel <NUM> through an opening (not depicted) formed in the sidewall of barrel <NUM> for the purpose of communicating pressurization information from the interior of barrel <NUM>.

In the illustrated embodiment a display <NUM> is provided to relate pressurization information to a user. Display <NUM> includes a display module <NUM>, display circuitry <NUM>, and a housing <NUM>. Display circuitry <NUM> is adapted to be coupled to display module <NUM>. Display circuitry <NUM> provides the pressurization and other information to be shown by display module <NUM>. Housing <NUM> comprises a housing base 48b and a housing hood 48a. Housing base 48b is adapted to receive display circuitry <NUM> and display module <NUM>. Housing hood 48a can then be secured to housing base to secure display circuitry <NUM> and display module <NUM> within housing <NUM>. Housing hood 48a is adapted to secure display module <NUM> such that it is viewable to a user.

By providing modularized components such as display module <NUM>, display circuitry <NUM>, and housing <NUM>, in connection with display <NUM>, a manufacturer can simply and efficiently assemble the components of display <NUM>. Additionally, by utilizing modularized components in connection with display <NUM> a manufacturer can independently test of each component of display <NUM>, before assembly and/or attachment to a syringe system or other inflation device. In this manner, in the event that a single component of display <NUM>, such as display circuitry <NUM>, is defective, the manufacturer can identify the defective component before assembly of display <NUM>. This allows the user to discard the defective individual component without discarding the entire display including non-defective components of display <NUM> and/or inflation syringe <NUM>. A method of modularized component assembly is discussed more fully below in conjunction with the discussion of <FIG> and <FIG>.

In the illustrated embodiment, display module <NUM> may comprise a numeric indicia, non-numeric indicia, and/or a timer display module. By providing numeric and non-numeric indicia, a simple and intuitive display of pressurization information can be provide to a user. Display module <NUM> is an example of a means for displaying inflation pressurization information. Display circuitry <NUM> processes electrical signals representing pressurization information that are output by a pressure sensing apparatus. Display circuitry <NUM> can also control the manner in which the display module <NUM> displays the pressurization information. Display circuitry <NUM> is provided as an example of a means for processing electrical signals from a sensor apparatus. Other examples of a means for processing electrical signals can include, but are not limited to, a microchip, a personal computer, and a handheld device such as a personal digital assistant (PDA). A method of displaying pressurization information using numeric indicia and non-numeric indicia is discussed below in conjunction with the discussion of <FIG> and <FIG>.

According to one aspect of the present invention, display <NUM> may further include a pressure sensing apparatus. The pressure sensing apparatus is positioned in fluid communication with the interior of barrel <NUM>. In the illustrated embodiment, the pressure sensing apparatus is integrated with display circuitry <NUM>. Display circuitry <NUM> and the pressure sensing apparatus of display circuitry <NUM> is positioned in fluid communication with the interior of barrel <NUM>.

As will be appreciated by those skilled in the art, a variety of types and configurations of displays can be utilized. According to the present invention, the display is provided separately from the inflation syringe. For example, the display can be provided as part of a reusable user interface which is operably connected to a disposable inflation syringe. Other examples of means for displaying inflation pressurization can also be utilized including, but not limited to, a cathode ray tube display, a liquid crystal display (LCD) screen, a grouping of light emitting diodes (LEDs), a handheld device such as a personal digital assistance (PDA), and a printer for printing out a hard copy display (not claimed, not forming part of the invention).

<FIG> depict a display <NUM> having numeric and non- numeric indicia for displaying pressurization information to a user in a simple and intuitive manner according to one aspect of the present invention. With reference now to <FIG>, in the illustrated embodiment, display <NUM> includes a non-numeric display <NUM> and numeric display <NUM>. Non-numeric display <NUM> comprises a plurality of indicia <NUM>. Indicia <NUM> are configured to provide a progressive display which depicts the pressurization of the inflation syringe in a simple and intuitive manner. The progressive configuration of display and corresponding indicia <NUM> can provide an indication of a range of inflation pressurization values. As indicia <NUM> are actuated, the user can quickly and simply determine the pressurization of the inflation syringe <NUM> allowing the practitioner to not only easily monitor the general intensity of the pressurization but also to monitor changes in the pressurization without needing to interpret numerical values. As a result, the user can quickly ascertain the relationship between the current pressurization, the desired pressurization, and the rate of pressurization without needing to interpret numeric values. In one embodiment, alternative measurements values other than pounds per square inch (psi), such as atmospheres or bar are provided.

In the illustrated embodiment, numeric display <NUM> of display <NUM> provides a numeric indication of the pressurization in the inflation syringe. Numeric display <NUM> provides an additional, precise indication of the inflation pressurization that complements the visual indication provided by the non-numeric indicia <NUM>. In the illustrated embodiment, numeric display <NUM> comprises a digital display, such as a <NUM>-segment LED display having multiple fields. As depicted, numeric display <NUM> includes three fields, each field representing a digit of the numeric value. Numeric display <NUM> displays a current pressurization value.

In the illustrated embodiment, display <NUM> may further comprise a timer display module <NUM>. Timer display module <NUM> provides an indication of the length of an inflation routine, the length of time between inflation routines, the length of time at a particular pressurization value, and/or the length of time that inflation pressure is applied to an attached inflatable medical device. Display <NUM> may also include a last value actuation button <NUM>. Las value actuation button <NUM> allows a user to toggle the numeric display <NUM> to display the maximum pressurization value achieved during the most recent, or previous, inflation routine.

In the illustrated embodiment, an exemplary current pressurization value of the inflation syringe is displayed as <NUM> kpa [<NUM> pounds per square inch (psi)]. The numeric display <NUM> is configured to provide a precise, intuitive indication of a value, which typically is the current pressurization of the interior of barrel <NUM>. During an inflation routine, numeric display <NUM> is automatically updated in real-time to provide the practitioner with an immediate, intuitive indication of the pressurization within the interior of the barrel and/or the tubing of the inflation syringe. The depicted <NUM>- segment LED display is provided as an exemplary display capable of providing a straightforward and easy-to-read, digital display at a low cost.

As previously discussed, in the illustrated embodiment non-numeric display <NUM> includes a plurality of non-numeric indicia <NUM>. Each of non-numeric indicia <NUM> comprises a white or colored LED. Additionally, each of the plurality of non- numeric indicia <NUM> of the non-numeric display <NUM> can represent one or more pressurization values. A plurality of numeric value indicators <NUM> are provided in connection with indicia <NUM> to provide a representation of the pressurization values corresponding to one, or a group of, non-numeric indicia <NUM>.

In the illustrated embodiment, each indicia <NUM> represents a range of pressurization values corresponding to approximately <NUM> kpa [five psi]. The numeric value indicators 50a, b, c, d, e, f, g are spaced along the indicia <NUM> , as shown, with a numeric value indicator corresponding with every tenth indicia <NUM>. As a result, the numeric value indicator 50a which is labelled as "<NUM>" clearly illustrates to the user than when no indicia is illuminated, or when indicia 51a alone is illuminated, the pressurization within the inflation syringe is zero kpa [<NUM> psi].

An exemplary non-numeric indicia 51b is also depicted. In the illustrated embodiment, indicia 51b is positioned approximately ten non-numeric indicia from indicia 51a. A numeric value indicator 50b which is labelled "<NUM>" is provided in connection with indicia 51b representing a pressurization within the inflation syringe of <NUM> kpa [fifty psi]. As a result, when the indicia from 50a to 50b are illuminated, the user can quickly and simply determine that the pressurization within the inflation syringe is <NUM> kpa [<NUM> psi].

As will be appreciated by those skilled in the art, when the pressurization within the inflation syringe is between zero and <NUM> kpa [zero psi and <NUM> psi], one of the non-numeric indicia <NUM> positioned between indicia 51a and 51b will be illuminated as the non- numeric representation of the pressurization within the inflation syringe. For example, in the event that the pressurization within the inflation syringe is <NUM> kpa [<NUM> psi], approximately <NUM> non-numeric indicia will be illuminated due to the fact that each non- numeric indicia represents a range of <NUM> kpa [five psi] of pressurization. In the event that the pressurization within the inflation syringe is <NUM> kpa [<NUM> psi], approximately <NUM> non-numeric indicia will be illuminated. The user can quickly ascertain the approximate pressurization within the inflation syringe by how close the last illuminated indicia is to a particular numeric value indicator. For example, when the pressurization in the inflation syringe is <NUM> kpa [<NUM> psi], the user can quickly identify that the last illuminated non- numeric indicia is greater than zero kpa [zero psi], less than <NUM> kpa [<NUM> psi]. Additionally, the user can quickly identify that the last illuminated non-numeric indicia is closer to <NUM> kpa [<NUM> psi] than zero kpa [<NUM> psi]. As a result, the non-numeric display <NUM> allows a user to quickly determine the approximate pressurization within the inflation syringe.

In the illustrated embodiment, numeric value indicator 50c indicates that an indicia 51c corresponds with a pressurization value of <NUM> kpa [<NUM> psi]. Numeric indicators 50d through <NUM> are similarly spaced, and respectively indicate that indicia 51d, 51e, 51f and <NUM> represent pressurization values <NUM> kpa, <NUM> kpa, <NUM> kpa, <NUM> kpa [<NUM> psi, <NUM> psi, <NUM> psi, and <NUM> psi], respectively. In the illustrated embodiment, non-numeric indicia <NUM> are lit in a progressive manner. Thus, all non-numeric indicia <NUM> representing values less than the current pressurization value remain lit as the pressurization increases and additional non-numeric indicia <NUM> are illuminated.

<FIG> illustrates a display <NUM> subsequent to previous pressurization routine of the inflation syringe. In the illustrated embodiment, there is little or no pressurization within the inflation syringe. As a result, numeric display <NUM> shows a pressurization of zero kpa [zero psi]. Additionally, non-numeric indicia 51a-51b are not illuminated.

In the illustrated embodiment, a non-numeric indicia 51e is illuminated. Non-numeric indicia <NUM> is illuminated as a representation of a value that represents something other than the current pressurization of the inflation syringe. According to one embodiment of the present invention, an indicia <NUM> , such as non-numeric indicia <NUM> e, can be lit to represent a last pressurization value and/or a target pressurization value. To avoid confusion, an indicia <NUM> representing a last value and/or a target value may appear a different color and/or flash or blink. In the illustrated embodiment, it is fairly simple to ascertain that non-numeric indicia <NUM> represents a last pressurization value and not the current pressurization value as the indicia between 51a and <NUM> e are not illuminated. As will be appreciated by those skilled in the art, a non-numeric indicia can be illuminated as an indicator of a last pressurization value while current pressurization is also be illuminated.

Display <NUM> may further comprise a user interface which allows a user to set a target pressurization value different from the last value. This may be accomplished by adjusting up or down from the displayed last pressurization value, or by manually entering a target value. In still another embodiment, last value actuation button <NUM> can enable the toggling of numeric display <NUM> between three values, current pressurization, last value, and target value. The target value may also be indicated by the non-numeric display <NUM>, either with the last value or in place of the last value, thus giving a user a visual representation of progress made in pressurizing the barrel, how much progress remains to reach the last value or a desired value, the rate of pressurization, and changes in pressurization resulting from each movement of the plunger within the barrel. Thus, the user can more easily ascertain the force necessary for subsequent movements of the plunger to reach the target pressurization value. The user interface may also enable the user to select other parameters to be displayed.

<FIG> depicts display <NUM> of <FIG> and <FIG> showing another manner of displaying last value information to a user, immediately after the user has pressed the last value actuation button <NUM>. In <FIG>, the barrel of the inflation syringe is completely depressurized, as indicated by numeric display <NUM> and non- numeric display <NUM>. If the user wants to view the exact last pressurization value, this information is not readily represented by indicia 51e because of the multiple possible pressurization values represented by each indicia <NUM>. To view the precise last pressurization value, the user can toggle the display by pressing last value actuation button <NUM>. In the illustrated embodiment, the user has pressed the last value actuation button <NUM>. Both indicia 51e of non-numeric display <NUM> and the <NUM>-segment display of numeric display <NUM> indicate the last value is <NUM> kpa [<NUM> psi]. By displaying the last value pressurization information on non-numeric display <NUM> and numeric display <NUM>, precise pressurization information is provided to a user in intuitive and easy to read manner.

In one embodiment of the present invention, display <NUM> may automatically toggle to display last value information at the end of an inflation routine. In the embodiment, display <NUM> will continue to display last value information on both the numeric display <NUM> and non-numeric display <NUM> until the beginning of the next inflation routine. At the beginning of the next inflation routine, display <NUM> may automatically toggle back to display current pressurization value information on numeric display <NUM> while retaining last value information using non-numeric display <NUM>. According to one embodiment of the present invention the, precise last value information may be available by pressing last value actuation button <NUM> at any time including during a subsequent pressurization routine. Indicia <NUM> e may appear a different color and/or flash to indicate it is presently representing a last value. In another embodiment, a user may adjust which indicia is appearing in a different color and/or which indicia is flashing while setting a target value which is different from the last pressurization value.

<FIG> illustrates display <NUM> during a subsequent pressurization routine in which the current pressurization of the inflation syringe is provided simultaneously with the last pressurization value. In the illustrated embodiment, non-numeric indicia <NUM> e is illuminated as an indicator of the last pressurization value. In other words, non-numeric indicia <NUM> e allows a user to quickly determine the maximum pressurization of the inflation syringe during the preceding inflation routine. Because non-numeric indicia 51e corresponds with an exemplary pressurization value of <NUM> kpa [<NUM> psi], the user can quickly determine that a maximum pressurization of <NUM> kpa [<NUM> psi] was utilized during the previous pressurization routine. This may be helpful where a practitioner desires to apply a similar, lesser or greater pressurization during subsequent pressurization routines. The configuration of display <NUM> allows a user to quickly ascertain the present pressurization value, the progress made and remaining to reach the last value and/or the target pressurization value, the rate of pressurization, and the progress made with each movement of the plunger, in an intuitive and simple to read manner.

In the illustrated embodiment, indicia 51a through 51c are illuminated. Additionally, approximately <NUM> additional indicia positioned between indicia 51c and <NUM> d are illuminated. Because indicia 51c represents a pressurization of <NUM> kpa [<NUM> psi], the user can quickly and simply ascertain that the pressurization in the inflation syringe represents a pressurization which is greater than <NUM> kpa [<NUM> psi]. Additionally, due to the fact that indicia <NUM> corresponds with a pressurization of <NUM> kpa [<NUM> psi], the user can quickly ascertain that the current pressurization in the inflation syringes represents a pressurization that is less than <NUM> kpa [<NUM> psi]. Due to the progressive nature of non- numeric indicia <NUM> and non-numeric display <NUM>, the user can visually determine that the pressurization is approximately <NUM> kpa [<NUM> psi] due to the fact that the last illuminated non-numeric indicia <NUM> is positioned approximately midway between <NUM> kpa [<NUM>] psi and <NUM> kpa [<NUM> psi]. This can be quickly confirmed by simply glancing at numeric indicia <NUM> which confirms that the pressurization in inflation syringe is exactly <NUM> kpa [<NUM> psi].

Providing a non-numeric display <NUM> in connection with a numeric display <NUM> provides an intuitive and simple to read display while also displaying more information simultaneously on the display than can be depicted on a numeric display alone. For example, the numeric display <NUM> can provide a current pressurization value while the non-numeric display <NUM> simultaneously displays a current pressurization value and a last pressurization value. In the illustrated embodiment, the user can determine the approximate pressurization of the inflation syringe utilizing the non-numeric display <NUM>. Additionally, the user can quickly and easily identify the relationship between the current pressurization and a target or last pressurization value. Additionally, the non-numeric display <NUM> can provide a visual representation of progress previously made in pressurizing the barrel, and of how much additional pressurization in needed to reach a desired value, such as the last pressurization value or a target pressurization value. For example, the user is provided with a visual indication that the current pressurization of <NUM> kpa [<NUM> psi] is approximately two-thirds of the last pressurization value represented by non-numeric indicia 51e. Additionally, the user can quickly ascertain that the current pressurization is slightly less than half of a maximum pressurization of <NUM> kpa [<NUM> psi] which corresponds with a non-numeric indicia <NUM>.

Display <NUM> also allows a user to easily monitor the rate of pressurization and changes in pressurization resulting from each movement of the plunger within the barrel. Thus, the user can more quickly estimate the force necessary for subsequent movements of the plunger to reach a desired pressurization value. In the illustrated embodiment, the arcuate or curved configuration of non-numeric display <NUM> allows a user to determine progress along a pressurization curve. The configuration of the pressurization curve provides subtle non-numeric indications in addition to actual pressurization values. For example, pressurizations corresponding with the bottom portion of the curve, i.e. indicia 51a-51c, can quickly be identified as below typically desired maximum pressurization values. As the pressurization approaches the arch or apex of the curve, i.e. indicia 51d-51f, the user can ascertain that the pressurization is within a range of typically desired maximum pressurization values. As the user passes the apex of the curve and begins to descend toward the final non-numeric indicia, i.e. 51f-<NUM>, the user can quickly determine that the pressurization exceeds typically desired maximum pressurization values. In this manner, the shape of the non-numeric indicia provides and indication of the desirability of given pressurization values in addition to actual pressurization values.

As will be appreciated by those skilled in the art, a variety of types and configurations of non-numeric displays can be provided. For example, a non-numeric display can comprise a progressive gauge or dial. In one example, the dial may be digital, comprising indicated by lights (e.g. LEDs), changing colors, notches, and/or other indicia. Only non-numeric indicia configured to be illuminated in a progressive manner fall under the scope of the invention. According to one embodiment of the present invention, the non-numeric display may comprise indicia arranged in a linear or curvilinear array. In still another embodiment there may be a plurality of instances of non-numeric indicia, each instance representing different pressurization values (e.g. current pressurization and last value). In still another embodiment the non-numeric indicia may be arranged in a non-linear configuration. In the illustrated embodiment, one side of the arcuate curve is longer than the other side of the curve to represent the respective desired ranges of values previously referenced.

According to an alternative embodiment of the present invention, different colors of pressurization can be provided as the pressurization increases along the pressure curve. For example, at low pressurization, the non-numeric indicia are illuminated green. At medium pressurization, the non-numeric indicia are illuminated yellow. At high pressurizations, the non-numeric indicia are illuminated red.

<FIG> is flow chart depicting a method of displaying pressurization information utilizing numeric and non-numeric indicia, according to one embodiment of the present invention. In the illustrated embodiment, the method begins at a step <NUM>. An inflation pressurization within the interior of the barrel is detected in a step <NUM>. Subsequent to detecting the inflation pressurization, the numeric value of the pressurization is displayed in a step <NUM>. The non-numeric value of the pressurization is then displayed in a step <NUM>. Once the numeric value of the pressurization is displayed in a step <NUM> and the non-numeric value of the pressurization is displayed in a step <NUM>, a change in pressurization is detected during an inflation routine in a step <NUM>. Once the change in pressurization is detected during the inflation routine, numeric and non-numeric changes in the pressurization values are displayed in a step <NUM>.

Subsequent to detecting of pressurization changes and display of numeric and non-numeric changes in pressurization values during steps <NUM> and <NUM>, a subsequent change in pressurization may be detected. In the event that a change in pressurization is detected during the inflation routine, step <NUM> is repeated. Once a change in pressurization is detected and step <NUM> is repeated, numeric and non- numeric changes in the pressurization values are again displayed in step <NUM>. An end of the inflation routine is detected in a step <NUM>. Once the end of an inflation routine is detected, non-numeric indicia corresponding to a last maximum inflation value of the previous inflation routine is displayed in a step <NUM>. Once the last maximum inflation values are displayed, in the event that an inflation pressurization is detected, the method returns to step <NUM>. In the event that an inflation pressurization is not detected, the method ends in a step <NUM>.

The detection of inflation pressurizations may be accomplished by a pressure sensing apparatus, such as a pressure sensing transducer. A display, such as depicted in <FIG>, may display the numeric value of the pressurization which provides a precise indication of the pressurization value. The display may also display non-numeric indicia as a representation of the value of pressurization. During the inflation routine, the pressure sensing apparatus may detect pressurization changes and then the display may update the numeric indicia and non-numeric indicia to display the changes in pressurization values. Detecting in step <NUM> and displaying in step <NUM> changes in pressurization values may occur multiple times during a pressurization routine. The method may also detect the end of the inflation routine and then display non-numeric indicia corresponding to the last value, or the maximum value, of the inflation routine that just ended. According to one embodiment of the present invention, the method may be directed by display circuitry (depicted in <FIG> , <FIG>, and <FIG>), and may be implemented in and/or carried out wholly or partially by software and/or hardware components.

<FIG> is a perspective view of an inflation syringe <NUM> illustrating a modularized component assembly of the inflation syringe <NUM>, according to one embodiment of the present invention. In the illustrated embodiment, display <NUM> comprises separate components as part of the modularized component assembly that allows for testing of the individual components of display <NUM>. By testing individual components of display <NUM>, the cost of manufacturing an inflation syringe of the present disclosure can be reduced because only defective components will be discarded, rather than discarding an entire inflation syringe.

As discussed with reference to <FIG>, barrel <NUM> may include a mounting bracket <NUM> to which display <NUM> may be attached. The mounting bracket <NUM> further comprises a securement clip slot <NUM> for receiving securement bracket <NUM>. Mounting bracket <NUM>, securement bracket slot <NUM> is an example of a means for attaching the display to a barrel of an inflation syringe. Other examples of means for attaching may include, but are not limited to a clip, hooks and loops, a pin, a detent, a button, or other fastener device.

Display circuitry <NUM> and display module <NUM> can be tested separately, assembled, and then placed into display housing base 48b. Display module <NUM> can comprise numeric and non-numeric indicia to display pressurization information. In the illustrated embodiment, display circuitry <NUM> is provided in connection with a flexible printed circuit board <NUM> to aid with assembly of display <NUM>. One or more batteries <NUM> may also be attached to flexible printed circuit board <NUM> for convenience during testing and assembly. Flexible printed circuit board <NUM> is configured to facilitate testing of display circuitry <NUM> by enabling batteries <NUM> to power display circuitry <NUM> during testing.

Display module <NUM> can be configured to be tested separately and also to be assembled with display circuitry <NUM> for further testing. During assembly, display circuitry <NUM> may be removed from flexible printed circuit board <NUM> and coupled to display module <NUM>. Batteries <NUM> may also be removed from flexible printed circuit board <NUM> and installed to power display circuitry <NUM>. The assembly can then be tested together before being placed into display housing base 48b. In another embodiment, flexible printed circuit board <NUM> can be permanently assembled with display circuitry <NUM> and display module <NUM>. According to yet another embodiment of the present invention, flexible printed circuit board <NUM> positions display circuitry <NUM> and batteries <NUM> in a desired position. Flexible printed circuit board <NUM> can then be removed once additional components such as display module <NUM> and housing <NUM> are assembled.

A display housing hood 48a is adapted to secure assembled display module <NUM> and display circuitry <NUM>. Housing hood 48a is configured to receive display module <NUM> and be coupled to housing base 48b, which may be already mounted to barrel <NUM>. Housing hood 48a and housing base 48b can then be snapped together for easy assembly. Once display <NUM> is attached to barrel <NUM>, the entire assembled inflation syringe may then be tested. Housing <NUM> is an example of a means for securing a processing means and a displaying means to an attaching means. Other examples of means for securing may include, but are not limited to a clip, hooks and loops, a pin, a detent, a button, or other fastener device.

<FIG> is a perspective view illustrating mounting of housing base 48b with barrel <NUM>. In the illustrated embodiment, a housing base 48b and a barrel <NUM> are depicted. As previously discussed, housing base 48b is configured to be coupled to barrel <NUM> during assembly of the inflation syringe apparatus. According to one embodiment of the present invention, housing base 48b is coupled to barrel <NUM> before assembly of the other components of the display <NUM> (see <FIG>). According to alternative embodiments of the present invention, the entire housing <NUM> of display <NUM> (see <FIG>) are assembled before coupling of housing base 48b to barrel <NUM>.

In the illustrated embodiment, housing base 48b comprises a void <NUM> and a button receiving bore <NUM>. Barrel <NUM> comprises a wall <NUM> and a securement bracket slot <NUM>. In the illustrated embodiment, a pressure sensor <NUM> is also depicted. During assembly, the user secures housing base <NUM> to barrel <NUM> by positioning void <NUM> over mounting bracket <NUM> of barrel <NUM>. The user then advances housing base 48b such that wall <NUM> of mounting bracket <NUM> slides through void <NUM>. As wall <NUM> of mounting bracket <NUM> slides through void <NUM>, wall <NUM> of mounting bracket <NUM> is positioned adjacent to void sidewall <NUM>. According to one embodiment of the present invention, the close spatial relationship between void sidewall <NUM> and wall <NUM> is provided to minimize lateral movement of housing base 48b relative to mounting bracket <NUM>. When a user has fully advanced housing base 48b such that housing base 48b is positioned adjacent to the bottom portion of mounting bracket <NUM>, securement bracket <NUM> is positioned within securement bracket slot <NUM> of mounting bracket <NUM>. In the illustrated embodiment, securement bracket <NUM> comprises a post which extends a vertical distance away from the underside of housing base 48b. Securement bracket slot <NUM> comprises a cut-out positioned on the rear side of mounting bracket <NUM>. Securement bracket slot <NUM> is sized to contact the lateral side portions of securement bracket <NUM> such that the cooperative engagement between securement bracket <NUM> and securement bracket slot <NUM> minimizes or eliminates undesired movement of that housing base 48b relative to mounting bracket <NUM>.

In the illustrated embodiment, a pressure sensor <NUM> is positioned within mounting bracket <NUM>. The position of mounting bracket <NUM> and pressure sensor <NUM> positions pressure sensor <NUM> in fluid communication with the interior of barrel <NUM>. In this manner, pressure sensor <NUM> can directly or indirectly monitor and relate information related to the pressurization of the fluid or air positioned within barrel <NUM>.

Mounting bracket <NUM>, securement clip <NUM>, and snap fitting <NUM> are examples of a means for attaching the display to a barrel of an inflation syringe. Other examples of means for attaching may include, but are not limited to a clip, hooks and loops, a pin, a detent, a button, or other fastener device.

<FIG> illustrates barrel <NUM> and housing base <NUM> when housing base has been securely coupled to barrel <NUM>. As can be seen in the illustrated embodiment, when housing base <NUM> is secured to mounting bracket <NUM>, a button receiving bore <NUM> is positioned at the distal end of barrel <NUM> such that a user can freely access and manipulate the button associated with button receiving bore <NUM>. In this manner, a user can actuate the button associated with button receiving bore <NUM> to control or monitor various aspects of the inflation syringe.

In the illustrated embodiment, wall <NUM> of mounting bracket <NUM> has a slight taper such that when a user first slides mounting bracket <NUM> through void <NUM> of housing base 48b, a predetermined amount of clearance is provided between wall <NUM> of mounting bracket <NUM> and sidewall <NUM> of void <NUM>. As a user continues to advance housing base 48b in the direction of barrel <NUM>, the clearance between wall <NUM> and sidewall <NUM> is decreased until the point in which full contact is provided on all four lateral sides of wall <NUM> and void sidewall <NUM>. In this manner, pressure or contact in any direction will not create inadvertent or undesired movement of housing base 48b relative to barrel <NUM>.

As will be appreciated by those skilled in the art, a variety of types and combinations of mechanisms for mounting the housing to the barrel can be utilized. For example, in one embodiment, the mounting bracket is provided in connection with the housing base and a void is provided in connection with the barrel. In another embodiment, the mounting bracket has a circular or elliptical configuration and the void has a circular or elliptical configuration to mate with the shape of the mounting bracket. In yet another embodiment, the pressure sensor is provided at a location other than the mounting bracket. In yet another embodiment, the plurality of mounting brackets or clip-type components are provided to secure the housing to the barrel.

<FIG> is a perspective view of components of display <NUM> illustrating assembly of the components of display <NUM> according to one embodiment of the present invention. In the illustrated embodiment, housing <NUM> (see <FIG>) comprises a housing hood 48a and a housing base 48b. Further, display <NUM> includes a display module <NUM>, display circuitry <NUM>, pressure sensor <NUM>, flexible printed circuit board 126a and 126b, and batteries <NUM>. In the illustrated embodiment, display module <NUM> and display circuitry <NUM> can be tested separately from one another before or after coupling of display circuitry <NUM> to display module <NUM>. In this manner, in the event that one or more components of the display <NUM> are faulty, the individual component can be discarded without needing to discard the other viable and usable components of display <NUM>. In the illustrated embodiment, display module <NUM>, display circuit <NUM>, and pressure sensor <NUM> are coupled together utilizing flexible printed circuit board 126a and 126b. Additionally, in the illustrated embodiment, batteries <NUM> are secured to flexible printed circuit board 126a. By securing display module <NUM>, display circuitry <NUM>, and securement bracket <NUM> utilizing flexible printed circuit board <NUM>, each of display module <NUM>, display circuitry <NUM>, and pressure sensor <NUM> can be positioned in their desired position within housing base 48b and housing hood 48a during assembly of housing hood 48a and housing base 48b while allowing desired coupling of housing base 48b to housing hood 48a.

In the illustrated embodiment, housing base includes a seat <NUM> , a retainment clip <NUM>, a coupling mechanism component 204a and 204b, securement post 208a and 208b, and receptacle <NUM>. Seat <NUM> is adapted to receive one or both of pressure sensor <NUM> and display circuitry <NUM>. In the illustrated embodiment, pressure sensor <NUM> is positionable within void <NUM> of housing base 48b such that pressure sensor <NUM> can be received within the mounting bracket <NUM> of barrel <NUM> (see <FIG>). In the illustrated embodiment, a retainment clip <NUM> is provided in connection with seat <NUM>. Retainment clip <NUM> is positioned such that the bottom edge of display circuitry <NUM> can be positioned beneath retainment clip <NUM>. In this manner, the bottom edge of the display circuitry <NUM> is positioned between retainment clip <NUM> and the back surface or bottom surface of housing base 48b. Once the bottom edge of display circuitry <NUM> is positioned between retainment clip <NUM> and the bottom of housing base 48b, the display circuitry <NUM> can be secured within housing base 48b.

Coupling mechanism components 404a, b are adapted to be secured to components of housing hood 48a to secure housing base to housing hood 48a. Additionally, securement posts 208a, b are adapted to help maintain clearance between the walls of housing hood 48a and housing base 48b while also providing a supplemental mechanism for securing housing hood 48a to housing base 48b. Receptacle <NUM> provides an open area within the volume provided by housing base 48b within which components of display <NUM> can be positioned. In the illustrated embodiment, receptacle <NUM> is adapted to receive flexible printed circuit board 126a and batteries <NUM>. Additionally, pressure sensor <NUM> and display circuitry <NUM> can be positioned within receptacle <NUM>.

In the illustrated embodiment, housing hood 48a includes coupling mechanism components 206a, b. Coupling mechanism components 206a and 206b are adapted to be secured to coupling mechanism components 204a and 204b of housing base 48b.

As will be appreciated by those skilled in the art, a variety of types and configurations of display components can be provided. For example, in one embodiment, the housing hood and housing base are provided as one integrated component. In another embodiment, housing base is integrally coupled to housing hood. In yet another embodiment, two or more of the components, including display module <NUM>, display circuitry <NUM>, batteries <NUM>, and flexible printed circuit boards <NUM> are provided separately and are coupled together once they are positioned within the components of housing hood and housing base. In yet another embodiment, the flexible printed circuit board or other wiring or circuitry to connect components of display <NUM> are integrated within the housing hood and housing base rather than being provided separately.

<FIG> is a perspective of the components of housing <NUM> according to one embodiment of the present invention. In the illustrated embodiment, a display module <NUM> has been secured within housing hood 48a. Additionally, the pressure sensor <NUM> has been threaded through void <NUM> of housing base 48b such that flexible printed circuit board 126a, and 126b are threaded between housing base 48b and housing hood 48a. In this manner, the display module <NUM> can remain operably connected to display circuitry <NUM> and pressure sensor <NUM> while mounting display module <NUM> within housing hood 48a and mounting sensor <NUM> through housing base 48b. Additionally, because batteries <NUM> are secured to flexible printed circuit board <NUM> and display circuitry <NUM> is operably connected to flexible printed circuit board 126a and flexible printed circuit board 126b, display module <NUM> can be actuated and tested in combination with display <NUM> during assembly.

<FIG> illustrates the components of display <NUM> during assembly of the components of display <NUM> according to one embodiment of the present invention. In this illustrated embodiment, display circuitry <NUM> has been positioned within seat <NUM> such that a leading edge of display circuitry <NUM> is positioned beneath retainment clip <NUM>. Flexible printed circuit board 126a has been folded such that pressure sensor <NUM> (not shown) is positioned through a void <NUM> (not shown) of housing base 48b. This positions batteries <NUM> in their desired position within receptacle <NUM> of housing base 48b. Additionally, this allows for the proper positioning of display circuitry <NUM> within seat <NUM>.

According to one embodiment of the present invention, the pressure sensor <NUM> is positioned through void <NUM> (see <FIG>). The length of flexible printed circuit board 126a positioned between batteries <NUM> and pressure sensor <NUM> is folded such that batteries <NUM> are positioned facing upward. The length of flexible printed circuit board <NUM> positioned between batteries and display circuitry <NUM> is folded such that batteries <NUM> are positioned upward and display circuitry <NUM> is positioned at the portion of housing base 48b and associated with seat <NUM>. Once display circuitry <NUM> is positioned within seat <NUM> , a length of flexible printed circuit board <NUM> can be slightly bended or folded to accommodate for the shortened distance between batteries <NUM> and display circuitry <NUM>. In other words, as display circuitry <NUM> is positioned beneath retainment clip <NUM>, the displacement between batteries <NUM> and displace circuitry <NUM> is lessen. The configuration of flexible printed circuit board 126a allows for subtle folding or other manipulation needed to accommodate for such changes in the juxtaposition of display circuitry <NUM> and batteries <NUM>.

In the illustrated embodiment, display module is secured within housing hood 48a. Flexible printed circuit board 126b is secured to display module <NUM> and display circuitry <NUM>. The length of flexible printed circuit board 126b allows for a desired separation between both housing hood 48a and housing base 48b while maintaining the connection between display module <NUM> and display circuitry <NUM>. In this manner, when display module <NUM> is positioned within housing hood <NUM> and display circuitry <NUM> is positioned within housing base 48b, the components can remain operably connected to one another while also allowing ongoing assembly of the components. In the illustrated embodiment, the coupling provided by flexible printed circuit board 126b also allows for testing of display circuitry <NUM> and display module <NUM> while operably connected to one another before final assembly of all the components of display <NUM>. When a user desires to finalize assembly of housing hood 48a and housing base 48b, flexible printed circuit board 126b can be folded such that flexible printed circuit board 126b is positioned between batteries <NUM> and display module <NUM> in a sandwich configuration while being entirely positioned within housing hood 48a and housing base 48b. This provides both improved testing of the components of the display <NUM> while also allowing for improved reliability and efficiency of manufacture of the components of display <NUM>.

It will be appreciated by those skilled in the art that a variety of types and configurations of securement of the components of display <NUM> can be utilized. For example, according to one embodiment of the present invention, a single length of flexible printed circuit board can be utilized to secure two or more components of the display. According to another embodiment, the batteries are secured to the other components of the display without utilizing flexible printed circuit board. According to yet another embodiment of the present invention, one or more components of the display are operably secured to one another when the housing hood is secured to the housing base.

<FIG> is a side cross-sectional view of display <NUM> illustrating the juxtaposition of housing hood 48a and housing base 48b after assembly of an inflation syringe. In the illustrated embodiment, housing base 48b is secured to housing hood 48a securing the position of display circuitry <NUM> within housing <NUM>. In the illustrated embodiment, housing base is secured to housing hood by the securement of coupling mechanism components 204a, b to coupling mechanism components 206a, b. Coupling mechanism components 204a, b are associated with housing base 48b. Coupling mechanism components 206a, b are associated with housing hood 48a. Additionally, according to one embodiment of the present invention, securement posts 208a, b are utilized to secure housing hood 48a to housing base 48b. In the illustrated embodiment, display module <NUM>, pressure sensor <NUM>, flexible printed circuit board 126a and flexible printed circuit board 126b are not shown. However, as previously discussed, the display module, pressure sensor, and flexible printed circuit boards are adapted to be operably connected within housing hood 48a and housing base 48b.

<FIG> is a perspective view illustrating housing hood 48a and housing base 48b when housing hood 48a is secured to housing base 48b. In the illustrated embodiment, no display module is shown within housing hood 48a for the purpose of illustrating the juxtaposition of the housing hood, 48a, housing base 48b and display circuitry <NUM>. In this manner, the user can observe the manner in which display circuitry <NUM> is secured utilizing retainment clip <NUM>. In the illustrated embodiment, clip <NUM> is positioned adjacent void <NUM> in housing base 48b. A user advances display circuitry <NUM> such that a leading edge of display circuitry <NUM> is positioned beneath retainment clip <NUM>. Once display circuitry <NUM> is positioned relative to retainment clip <NUM>, display circuitry <NUM> can be secured within housing base 48b. In one embodiment, display circuitry <NUM> is secured within seat <NUM> by the cooperative engagement of housing hood 48a and housing base 48b. According to another embodiment of the present invention, the components of housing base 48b alone secure display circuitry <NUM>. In another embodiment, once display circuitry <NUM> is positioned relative to retainment clip <NUM>, display circuitry is welded, glued, or otherwise secured mechanically to housing base 48b. In the illustrating embodiment, display circuitry <NUM> is positioned at an angle within housing base 48b by being positioned at a sloped angle relative to the other components of housing base 48b. Flexible printed circuit board, batteries, or other components to be positioned within receptacle <NUM> of housing base 48b can be positioned in a desired manner without impedance from or interference to display circuitry <NUM>.

As will be appreciated by those skilled in the art, a variety of types and configurations of housings can be provided without departing from the scope and spirit of the present invention. For example, in one embodiment of the present invention, a mechanism other than a retainment clip is utilized to secure the display circuitry. In another embodiment, the display circuitry is positioned within its own receptacle to protect it from damage from the other components of the display. In yet another embodiment, the display circuitry is positioned away from the void of the housing base to protect the display circuitry from the external environment.

Modularized component assembly, and testing of individual and assembled components during the assembly, enable identification of defective components. Consequently, significant cost reduction may be achieved simply by discarding only defective components rather than discarding entire inflation syringes which may include several inflation syringe components which are not defective.

<FIG> is a flow chart illustrating a method of testing and assembling an inflation syringe utilizing a modularized component assembly, according to one embodiment of the present invention. The method begins at a step <NUM>. The components of the inflation syringe are obtained in a step <NUM>. Once the components of the inflation syringe are obtained, the integrity of the inflation syringe barrel is tested in a step <NUM>. The operation of the display circuitry is then tested in a step <NUM>. Once the operation of the display circuitry is tested, the operation of the display module is tested in a step <NUM>.

The housing base is then secured to the mounting bracket of the inflation syringe in a step <NUM>. Once the housing base is secured to the mounting bracket, the display module and circuitry are assembled in a step <NUM>. The display module and circuitry are placed in the housing base in a step <NUM>. Once the display module and circuitry are placed in the housing base, the housing hood is coupled to the housing base to secure the display module and circuitry to the inflation syringe in a step <NUM>. The assembled inflation syringe including the assembled display then undergoes final testing in a step <NUM>. Once the assembled inflation syringe has undergone final testing, the method is ended in a step <NUM>.

According to one embodiment of the present invention, the preassembled components may include, but are not limited to, a pre-assembled syringe system comprising a barrel and plunger, a display housing comprising a base and a hood, a display module, and display circuitry. In another embodiment, a tubing may be preconnected to the barrel with the tubing being adapted to connect to an inflatable medical device. Each of the components of the inflation syringe may be tested separately. The method may test the integrity of the syringe system, including the barrel and plunger and any other syringe system components to ensure a fluid tight seal and to ensure that the barrel can be pressurized and hold pressurization. According to one embodiment of the present invention, the testing method is adapted to test operation of the display circuitry and test operation of the display module, including testing of both the numeric and non-numeric indicia.

Claim 1:
A modularized component assembly including an inflation syringe (<NUM>) and comprising:
a barrel (<NUM>) defining an inner lumen and being adapted to hold a desired inflation pressure;
a plunger (<NUM>) configured to be received within the inner lumen of the barrel (<NUM>) to increase pressurization with the barrel (<NUM>);
a sensor apparatus (<NUM>) for sensing inflation pressurization within the barrel (<NUM>);
a display processor to process signals received from the sensor apparatus (<NUM>);
a display module (<NUM>) coupled to the display processor to display information contained in the signals from the sensor apparatus (<NUM>), wherein the display module (<NUM>) comprises a plurality of non-numeric indicia (<NUM>) which are configured to provide a non-numeric representation of the current inflation pressurization within the barrel (<NUM>);
a display housing (<NUM>) comprising a base (48b) and a hood (48a), wherein the base (48b) is configured to attach to the barrel (<NUM>) and to receive the display processor and display module (<NUM>), and wherein the display hood (48a) is configured to couple to the display base (48b) and secure the display processor and display module (<NUM>) within the display housing (<NUM>); wherein:
the plurality of non-numeric indicia (<NUM>) is
configured to be illuminated in a progressive manner to provide a non-numeric representation of the current inflation pressurization;
the non-numeric indicia (<NUM>) is configured to represent values less than
the current inflation pressurization value remain illuminated as the pressurization within the barrel (<NUM>) increases and decreases; and
the display module (<NUM>) is configured to illuminate one non-numeric indicia (51e) of the plurality of non-numeric indicia (<NUM>) different than other non-numeric indicia (<NUM>) of the plurality of non-numeric indicia as a representation of a value that represents something other than the current inflation pressurization.