NZ612754B2 - Apparatus and methods for inflating and deflating balloon catheters - Google Patents

Abstract

inflation/deflation syringe (100) that enables one-handed operation to inflate a medical device to a given pressure or volume and one-handed operation to deflate said medical device is disclosed. The syringe has a syringe barrel comprising multiple chambers of multiple diameters (101) and a syringe plunger (102) comprising multiple diameters sized to fit within the syringe barrel. The syringe plunger has segments and the segment with the largest diameter is hollow and in fluid communication with the largest diameter segment of the syringe barrel (101’). A piston and/or seal is disposed and hermetically sealed within the inner chamber of the syringe plunger segment of largest diameter. The syringe barrel chamber of largest volume provides vacuum and/or a reservoir for inflation media. ge plunger (102) comprising multiple diameters sized to fit within the syringe barrel. The syringe plunger has segments and the segment with the largest diameter is hollow and in fluid communication with the largest diameter segment of the syringe barrel (101’). A piston and/or seal is disposed and hermetically sealed within the inner chamber of the syringe plunger segment of largest diameter. The syringe barrel chamber of largest volume provides vacuum and/or a reservoir for inflation media.

Description

APPARATUS AND METHODS FOR ING AND DEFLATING BALLOON CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US. Provisional Application No. 61/430,082 filed on January 5, 2011, the disclosures of which is herein incorporated by reference in its FIELD OF THE INVENTION This invention generally relates to medical procedures within the human or mammalian body that utilize an inflation and/or deflation device to inflate or deflate a n or an inflatable membrane in procedures such as angioplasty, vertebroplasty and sinuplasty.

BACKGROUND The use of the various devices in medical procedures entail a fair degree of manual dexterity on the part of the physician ming the procedures and frequently require the aid of one or more assistants to successfully complete the procedures. One such ure is the inflation and deflation of balloon systems such as those employed in angioplasty, vertebroplasty? and sinuplasty Withstaiidard inflation devices. Device preparation which involves purging or evacuation of air from the balloon systems can be particularly demanding, commonly requiring the use of both hands of a single operator. Many of the medical procedures performed using balloon systems require the physician to use both hands in order to maneuver, on and hold these medical devices during the on or deflation steps, thus presenting the need for a second operator to accomplish procedure.

A number of commercial products are available that attempt to address one or more of the challenges associated with controlling the inflation and deflation of a balloon . Many of these products are focused on providing e control over the amount of pressure that is applied to the expandable member of the PCT/U82012/020201 balloon system, as a large contingent of dilatation procedures require a relatively high amount of pressure in order to ly displace tissue, , bone and the like. For example, many commercial available inflation devices comprise a syringe with a pressure gauge attached, wherein the syringe plunger is free to move longitudinally within the inner bore ofthe syringe barrel by pulling on a handle provided on the syringe plunger proximal end. The action of retracting the syringe plunger proximally provides a vacuum within the syringe to draw fluid or air into the syringe barrel. Conversely, pushing on the handle of the syringe plunger discharges the fluid or air out of the syringe. In a closed system (e.g. when the inflation device is attached to a balloon catheter) a sealing member (typically attached to the distal end of the syringe plunger) acts as a gasket to prevent fluid or air to leak around the gap between the inner wall of the syringe barrel and the outer surface of the syringe plunger when the e plunger is advanced s the distal end of the inflation device (in order to generate pressure) or retracted proximally (in order to generate vacuum). The g member attached at the distal end ofthe syringe plunger allows the fluid or air within the closed system (the inflation/deflation device and the coupled medical device such as balloon catheter) to be compressed, increasing the al pressure as the plunger continues to advance distally. The operator can e the reading on the pressure gauge to ascertain that magnitude of pressure within the system. Another ism of inflation comprises a syringe plunger that is threaded, wherein the thread is engaged with an element of the device so that the longitudinal movement in the distal ion within the syringe barrel is effected by rotation of the threaded syringe r thus building up re within the device. The descriptions ofthese inflation devices are referenced in US. Pat. Nos. 4,743,230, 4,832,692, 5,507,727, and 970 which have been incorporated herein by reference. Other designs such as the locking syringe described in US. Pat. Nos. 015, 078, and 5,209,732 (herein incorporated in full by reference) allow for the selection and maintenance ofa given inflation pressure.

Another method ofsimplifying the inflation and/or deflation ofa balloon or other expandable member is rated in devices that allow for a pre-selected level of negative pressure to be applied and maintained without nt effort on the part of the operator. One example ofthis type of design is the VacLok® series of syringes available from Merit Medical. These devices comprise a polycarbonate PCT/U52012/020201 syringe body with a stop pin and a plunger with g fins that prevents relative motion of the plunger with respect to the syringe body when the fins are engaged with the stop pin. Vacuum is applied and maintained by retracting the syringe r to create a desired ve pressure, then rotating the plunger to position one ofthe locking fins al to the stop pin. The interference between the locking fin and the stop pin prevents distal motion of the plunger and the release of negative pressure. These types of designs are taught in U.S. Pat. No. 5,215,536 and are herein incorporated by reference.

Another typical inflation/deflation syringe set up that may be used for inflation and deflation ofa medical device such as balloon catheter comprises a small volume syringe [e.g. 1ml syringe), a large volume syringe (eg. 10 ml syringe) and a manifold (eg. 3 way manifold or stopcock) assembled together. The small volume syringe is used to provide high inflation pressures with minimal effort (due to the relatively small syringe plunger cross section), the large volume syringe is used to apply vacuum for deflation as well as serve as a reservoir for the inflation fluid media, and the manifold or stopcock functions to open or close ports enabling communication between the balloon catheter and the desired syringe. The use of the large syringe is needed as the small syringe is not capable of ing the magnitude ofvacuum required for timely to deflation ofthe balloon, nor does it hold a sufficient volume of fluid to compensate for the void volume ofthe balloon catheter, inflate the balloon to a neutral pressure, and further increase the re in the balloon to the desired level. The method ofinflation or deflation es ng the valve ofthe manifold or stopcock in order for the balloon catheter to communicate with the inflation e or the deflation e. For example, a high re balloon may be inflated by rotating the valve ofthe manifold or stopcock to open a flow path between the larger syringe and the balloon er. After evacuating the air in the balloon catheter, the larger syringe in sed to fill the void volume ofthe balloon catheter and begin inflating the balloon. At this point, the force required to further inflate the balloon exceeds the amount that can be comfortably applied by the operator. The valve ofthe manifold or stopcock is rotated further to close the flow path between the larger syringe and the balloon catheter and open a flow path between the r syringe and the balloon catheter.

The operator ues to inflate the balloon to the desired pressure by depressing the smaller syringe. Once the desired pressure has been achieved, the valve ofthe manifold or stopcock is rotated to close all flow paths between the syringes and the balloon catheter. Deflation of the balloon is achieved by rotating the valve of the manifold or stopcock to open a flow path between the larger syringe and the n catheter and retracting the plunger of the larger syringe to generate a negative pressure in the syringe barrel. The negative pressure draws fluid out of the balloon er and deflates the balloon. In this set up, it is nt that there is an added operator burden or difficulty since the operation involves several manipulations of a stopcock or manifold in order for the system to operate correctly.

While these inflation devices have utility, they are not the most efficient and convenient for the physician and medical staff to use in the field due to the need for two hands to successfully operate the devices, the mics and bulk ofthe current designs, and the number steps needed to prepare and deploy the inflation mechanism.

An inflation and/or deflation device that would simplify the dilation of an expandable member, such as a n catheter, that can be successfully operated with one hand would relieve the burden placed on the ian operator and associated staffduring often x medical procedures, and thus potentially presents a labor cost savings.

Relevant Literature U.S. Pat. Nos. 4,743,230; 4,832,692; 5,047,015; 5,057,078; 5,209,732; ,215,536; 5,507,727; and 7,530,970.

SUMMARY OF THE INVENTION This invention is directed to improve the inflation/deflation ofballoon dilation systems as used in angioplasty, vertebroplasty, sinuplasty, and similar procedures by ng a user to achieve a high inflation pressure with a single hand.

This invention relates to a device that has the ability to inflate a balloon or other ble structures. [0011A] In a first aspect of the present invention, there is provided an inflation/ deflation syringe that generates pressure or delivers a controlled volume, comprising: a e barrel comprising multiple chambers of multiple diameters; a syringe plunger comprising multiple diameters sized to fit within the syringe barrel, wherein a syringe r t of largest diameter is hollow and in fluid communication with the largest diameter segment of the syringe barrel; and a piston and/or seal disposed and hermetically sealed within an inner chamber of the syringe plunger segment of largest diameter. [0011B] Also described herein is a method of using the inflation/deflation syringes ing to the first aspect or any one of claims 22, 24, or 26, the method comprising: drawing inflation media into the syringe barrel chambers; expelling excess gas and/or inflation media from the syringe barrel chambers; connecting to the inflation port of a medical ; transferring inflation media into the l device to a desired re and/or volume, and withdrawing inflation media from the medical device when desired to return the pressure and/or volume ofthe inflation media within the medical device to a desired level. 2012/020201 BRIEF PTION OF THE DRAWINGS The invention is best tood from the following detailed description when read in ction with the accompanying drawings. It is emphasized that, according to common practice, the s features ofthe drawings are not to—scale.

On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawings are the following s.

FIGS. 1A-1C depict cross—sectional views ofan embodiment ofthe invention comprising a pressure limiting feature and a series deflation and inflation syringe arrangement.

FIGS. 2A-2E depict a method of operation of the embodiment ofthe invention illustrated in FIGS. 1A—1C.

FIGS. 3A-3B depict a magnified View of the operation ofthe re control mechanism.

FIGS. 4A-4B depict a serial syringe arrangement without incorporating the additional features ofthe present invention.

FIGS. SA-SB depict a magnified view ofthe deflation plunger during the inflation process. depicts a cross section of an embodiment ofthe invention comprising a movable plunger. -7C depict a method ofoperation ofthe embodiment ofthe invention illustrated in FIGS. 8A-BB depict cross-sectional views of an embodiment of the invention comprising a pressure limiting e and a parallel deflation and inflation syringe arrangement. -9C depict a method ation ofthe embodiment ofthe invention illustrated in FIGS. 8A-8B.

W0 2012/094403 PCT/U52012/020201 DETAILED DESCRIPTION Before the present invention is bed, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. it is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be ng, since the scope of the present invention will be limited only by the appended claims.

Where a range ofvalues is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits ofthese smaller ranges may ndently be included or excluded in the range, and each range where either, neither or both limits are included in the r ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both ofthe limits, ranges excluding either or both of those included limits are also included in the ion.

Unless defined otherwise, all technical and scientific terms used herein have the same g as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or g of the t invenu'on, some potential and preferred methods and als are now described. All publications mentioned herein are orated herein by reference to se and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present sure supersedes any disclosure of an incorporated ation to the extent there is a contradiction.

It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a compound" includes a plurality of such compounds and reference to "the polymer" includes reference to one or more polymer and equivalents thereof known to those skilled in the art, and so forth.

PCT/U52012/020201 The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be ued as an admission that the present invention is not entitled to antedate such publication by Virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

Figures 1A-1C illustrate one embodiment of the invention. on/deflation syringe 100 is comprised ofa e barrel 101, a deflation plunger 102, and an inflation plunger 103. The syringe barrel 101 is sed of at least two integrated syringe barrel chambers, 101’ and 101”, with at least two different cross sectional inner diameters, preferably oriented in a serial uration. The syringe barrel 101 configuration in the preferred embodiment comprises a smaller volume syringe barrel chamber 101” (eg. with a volume ty of about 1 ml), located in series and preferably distal to the larger volume syringe barrel chamber 101‘ (e.g. with a volume capacity equal to or greater than 5 ml). The smaller volume syringe barrel chamber 101" is dimensioned to have a relatively small inner diameter and is used as the on chamber. The larger volume syringe barrel chamber 101' is dimensioned to have a larger inner diameter relative the smaller volume syringe barrel and is used as the deflation chamber as well as a reservoir for inflation fluid media such as air or liquid. Disposed within the syringe barrel 101 are on plunger 102 and inflation plunger 103, oriented in series, each plunger sized to fit inside one ofthe individual inner diameters ofthe syringe barrel 101. The smaller diameter on plunger 103 fits inside the smaller e barrel chamber 101” and the larger diameter deflation plunger 102 fits inside the larger syringe barrel chamber 101’. The distal most tip of syringe barrel 101 comprises a port connector 124- that enables fluid and/or air communication between inflation/deflation syringe 100 and an al device.

Port connector 124 may include but is not limited to fixed male or female luer lock fittings, rotating male or female luer lock fittings, hose barbs, slip luers, quick release fittings, and the like. In place ofa port connector provided at the distal end of the e barrel 10 1, an ion line or tubing (not shown) may be permanently attached to the distal end of the syringe barrel 101 and the port connector 124 may attached to the distal end of the extension line (not shown).

Syringe barrel 101 also comprises at least one ring 123 or a similar feature, PCT/USZOIZ/OZOZOI including but not limited to flanges, indentations, wings, bars, grips, and the like, that may be used by the or to allow the syringe body to be single-handedly held and to provide ity when advancing or retracting the deflation plunger 102. Syringe barrel 101 may be fabricated from materials known in the art, ing but not limited to polycarbonate, polypropylene, polymethylmethacrylate, PET, PEEK, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or ations thereof, and may be transparent, translucent, opaque, or any gradient thereof.

As shown in Figure 18, deflation plunger 102 further comprises a deflation plunger tip 104, on plunger U'p port 113, deflation plunger seal 105, deflation r body 106, deflation plunger chamber 107, piston seal 108, piston 109, piston return spring 110, pressure e port 111, media release port 125, and plunger ring 1 12. Deflation plunger body 106 may be fabricated from materials known in the art, including but not limited to polycarbonate, polypropylene, polymethylmethacrylate, PET, PEEK, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or ations thereof, and may be transparent, translucent, opaque, or any gradient thereof. Deflation plunger tip 104 is joined the distal end of deflation plunger 106 using methods known in the art including, but not limited to press fitting, adhesive bonding, ultrasonic welding, threading/tapping, heat , overmolding, use ofa set screw, and the like and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, ®, polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, PTFE, stainless steel, brass, aluminum, titanium and the like or combinations f. The on plunger tip 104 and the deflation plunger body 106 may be integrated and ctured as single component by means of commonly known fabrication techniques such as machining, injection molding, casting, and the like. The deflation r tip 104 may comprise at least one deflation plunger tip port 113. Deflation plunger tip port 113 may be fabricated using methods known in the art including, but not limited to laser cutting and or engraving, mechanical machining, electrical discharge machining, chemical etching, and the like. Alternatively, deflation plunger tip port 113 may be formed in deflation plunger tip 104 as a feature of deflation plunger tip 104 during a molding process. Deflation plunger seal 105 is sized and arranged W0 2012/094403 PCT/U52012/020201 such that it provides an air and/or fluid tight seal between the deflation r tip 104 and the inner surface of larger syringe barrel 101’ and may be fabricated from materials including, but not limited to polychloroprene, silicone rubber, nitrile rubber, , EPDM, butyl rubber, natural rubber, hylene, and the like.

While deflation plunger seal 105 is depicted as an o-ring in , it should be clear to those of skill in the art that lent components such as gaskets may be interchanged with deflation plunger seal 105. For example, deflation plunger seal 105 may be an integral part of deflation r tip 104, such as one or more flanges molded, machined, or ise manufactured as a feature of deflation plunger tip 104 that provides an air and/or liquid tight seal between on plunger tip 104 and the inner surface oflarger e barrel 101’. Piston 109 coaxially resides within deflation plunger chamber 107 and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone rubber, nitrile rubber, , EPDM, butyl , natural rubber, PTFE, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or combinations thereof. Piston 109 is biased by piston return spring 110 such that the distal face of piston 109 is positioned against the proximal face ofdeflation plunger tip 104. Piston seal 108 may be held within a feature such as a groove or channel on piston 109, and is sized such that it s an air and/or liquid tight seal between piston 109 and the inner surface of on plunger body 106 while allowing translation of piston 109 along deflation plunger chamber body 106 and may be fabricated from materials including, but not limited to polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, polyethylene, and the like. While piston seal 108 is depicted as an o- ring in , it should be clear to those of skill in the art that equivalent components such as gaskets may be interchanged with piston seal 108. For example, piston seal 108 may be an integral part ofpiston 109, such as one or more flanges molded, machined, or otherwise manufactured as a feature of piston 109 that provides an air and/or liquid tight seal between piston 109 and the inner surface of deflation plunger body 106. Piston return spring 110 resides within deflation plunger chamber 107, and has a combination of spring rate, , pitch, wire thickness, and outer diameter such that the distal end of piston return spring 110 places a compressive load against the piston 109. Piston return spring 110 may PCT/USZOIZ/OZOZOI be fabricated from materials known in the art including but not limited to high carbon wire, alloy steel, stainless steel, nitinol, non-ferrous alloy, high-temperature alloy, and the like. Pressure release port 111 is provided to t pressure build up inside the deflation plunger chamber when the piston moves proximally. r ring 112 may be comprised of at least one ring or a similar feature, including but not d to flanges, indentations, wings, bars, grips, and the like, that may be used by the operator to allow the deflation plunger 102 to be held with a single hand and provide stability when advancing or retracting the deflation plunger 102. Media e port 125, located at the proximal side ofthe deflation plunger body 106, may be incorporated as an overflow port for the excess air or fluid contained inside the syringe barrel 101. Preferably, the pressure release port is located distal of the piston seal 108 when the piston return spring 110 is fully ssed.

Figure 1C shows inflation plunger 103 in detail, comprising inflation r tip 114, inflation plunger tip port 115, inflation plunger seal 116, inflation plunger housing 117, face seal 118, outlet port 119, pressure control spring 120, pressure control piston 121, and inflation rod 122. The proximal end ofinflation rod 122 is attached to the deflation plunger tip 104; the two ents may be joined by methods known in the art including but not limited to press fitting, adhesive bonding, onic welding, threading/tapping, overmolding, heat fusing use ofa set screw, and the like. Alternatively, inflation rod 122 and on plunger tip 104 may be ed, molded, cast or otherwise formed as a single component. Yet another alternative configuration is to fabricate the inflation rod 122, deflation plunger tip 104 and deflation plunger body 106 as a single component by means of machining, molding, casting or the like. Inflation rod 122 may be fabricated from materials known in the art including but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, Delrin®, PTFE, stainless steel, brass, um, titanium and the like or combinations thereof. The proximal end ofinflation plunger housing 1 17 is joined to the distal end of inflation rod 122 by s known in the art that include but are not limited to press fitting, adhesive bonding, ultrasonic welding, threading/tapping, overmolding, use ofa set screw, and the like and may be fabricated from als known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone rubber, nitrile rubber, PCT/U82012/020201 , EPDM, butyl , natural rubber, PTFE, stainless steel, brass, aluminum, titanium, licate glass, ceramics, and the like or combinations thereof.

Alternatively, inflation plunger housing 117 and inflation rod 122 may be machined, molded, or otherwise formed as a single integrated component Inflation plunger housing 117 further comprisesoutlet port 119. Outlet port 119 may be fabricated using s known in the art including but not limited to laser cutting and or engraving, mechanical machining, electrical discharge machining, chemical etching, and the like. Alternatively, outlet port 119 may be formed in inflation plunger housing 117 as a e ofinflation plunger housing 117 during a molding process.

Inflation plunger tip 114 is joined to the distal end ofinflation plunger housing 117 using methods known in the art including, but not limited to press , adhesive bonding, onic welding, threading/tapping, overmolding, heat fusing, use ofa set screw, and the like and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, PTFE, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or combinations f. Inflation plunger tip 114 further ses at least one inflation r tip port 115 extending from the distal to proximal ends ofinflation plunger tip 114, and may be fabricated using s known in the art including, but not limited to laser cutting and or engraving, mechanical machining, electrical discharge machining, chemical etching, and the like. Alternatively, inflation plunger tip port 115 may be formed in on plunger tip 114 as a feature ofinflation plunger tip 114 during a molding process. on plunger seal 116 may be held within a feature such as a groove or channel on inflation plunger tip 114, and is sized such that it creates an air and/or liquid tight seal between inflation plunger tip 114 and the inner surface of r syringe barrel 101" and may be fabricated from materials ing, but not limited to polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, polyethylene, and the like. While inflation plunger seal 116 is depicted as an o-ring in , it should be clear to those of skill in the art that equivalent components such as gaskets may be interchanged with inflation plunger seal 116. For example, inflation plunger seal 116 may be an integral part of on plunger tip 114, such as one or more flanges molded, machined, or PCT/U82012/020201 otherwise manufactured as a feature of inflation plunger tip 114 that provides an air and/or liquid tight seal between inflation plunger tip 1 14 and the inner surface of smaller syringe barrel 101". Face seal 118 resides inside inflation plunger housing 117 and is sized to provide an air and/or fluid tight seal when pressed against the proximal end of the inflation plunger tip 114. Face seal 118 may be ated from materials known in the art including but not limited to polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber and the like. The distal face of pressure control piston 121 contacts the proximal surface of face seal 118. Pressure control piston 121 may be joined to face seal 118 or the two components may be decoupled from each other. Methods ofjoining the two components may se but are not limited to press fitting, adhesive bonding, ultrasonic welding, threading/tapping, overmolding, use of a set screw, and the like. Pressure control piston 121 may be fabricated from materials including but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, ®, PTFE, stainless steel, brass, aluminum, titanium and the like or combinations thereof. Alternatively, the re control piston 121 and the face seal 118 may be combined and may be made of a single component. Yet another alternative configuration is to eliminate the use ofpressure control piston 121 by incorporating the features of the piston 121 to the face seal 119. The al end ofpressure l piston 121 serves as a base to stabilize the distal end of pressure control spring 120. Pressure control spring 120 resides within on plunger housing 117 such that the distal end of pressure control spring 120 places a compressive load on pressure control piston 121. re control piston 121 transmits at least some ofthe ssive load applied by pressure control spring 120 to the proximal surface offace seal 118, thus maintaining a seal between inflation plunger tip 114 and the distal surface of face seal 118. Pressure control spring 120 maintains this seal until a desired pressure is exceeded; this re is dictated by the force (or spring force constant) of pressure control spring 120 at a given length of compression by specifying the overall length, pitch, wire thickness, wire material and outer diameter of pressure l spring 120. Pressure control spring 120 may be fabricated from materials known in the art ing but not limited to high carbon wire, alloy steel, stainless steel, nitinol, non-ferrous alloy, high-temperature alloy, and the like.

PCT/U82012/020201 Alternatively (not shown), on plunger seal 10S and inflation plunger seal 116 may reside on a channel, groove, or similar feature oflarger syringe barrel 101' and smaller syringe barrel 101”, respectively, that allow for hermetic seals between larger e barrel 101’ and on plunger 102, and smaller syringe barrel 101” and inflation plunger 103. In this embodiment, the outlet port 119 is positioned or located proximal of the inflation plunger seal 116 when the deflation plunger 102 is fully depressed into syringe barrel 101. The outlet port 119 may be incorporated to the on rod 122 by way of ing an inner lumen or opening (not shown) through the length ofinflation rod 122 originating from the distal end and terminating at the al end ofthe inflation rod 122.

Alternatively, the location of inflation r housing 117, face seal 118, pressure control spring 120, and pressure control piston 121, may be positioned proximally (not shown) by increasing the length ofthe inflation plunger tip 114 and decreasing the length ofthe inflation rod 122, thus shifting the outlet port 119 proximal ofthe on plunger seal 116 when the deflation plunger 102 is fully depressed into syringe barrel 101.

Figures ZA-ZE illustrate a method ofthe using one embodiment of the inflation/deflation syringe of the invention. The on/deflation syringe 100 can be used to inflate and deflate an inflatable element [not shown) ofa medical device such as balloon catheter (not shown) and the like. Figure 1A shows the relative position ofthe elements of the components of the invention in an initial configuration wherein the deflation r 102 is advanced until the inflation plunger tip is at the distal side of the smaller syringe barrel 101". The syringe barrel 101 is then filled with inflation media, preferably a fluid, by fully retracting the deflation plunger 102 to the on shown in Figure ZB. This step can be repeated until the syringe barrel 101 is sufficiently filled with inflation media such that when the inflation/deflation syringe 100 is held vertically with the distal end pointing up, the level of the inflation media is above the distal tip of the inflation plunger 103. Excess on media and/or air or air s above the fluid level inside the syringe barrel 101 the can be purged out by advancing the deflation plunger 102, while the syringe 100 is held vertically, and further advanced until the distal tip ofthe inflation plunger 103 is aligned at or near the proximal end ofthe smaller syringe barrel 101" as shown in Figure 2C. A visual indicator (not shown) such as printed markers or the like, or a tactile indicator such as detents or the like, PCT/U52012/020201 may be incorporated into the on/deflation syringe 100 to aid the user in filling the lumen of the syringe barrel 101 with the proper amount or volume of inflation media. The syringe port connector 124 may then be attached to the medical device inflation port. Alternatively, an inflation line extension (not shown) may be attached to the syringe port tor 124 prior to purging the excess inflation media. Once the inflation line extension is connected, excess on media and/or air or air bubbles above the fluid level inside the syringe barrel 101 the can be purged out by advancing the deflation plunger 102 while the syringe 100 is held vertically. At this point, the on line lumen (not shown) should be filled with inflation media and the distal end of the ion line can be ed to a medical device such as a balloon catheter, for example.

The balloon er may be prepared by aspirating the air out of the balloon inflation path by fully retracting the deflation plunger 102 and allow the air/air bubbles to be purged out [not shown). This is done by holding the syringe 100 such that the distal tip is pointed down prior to retracting the deflation plunger 102 and then releasing to l. Figures 2D and 2E show the subsequent one-handed inflation of the balloon catheter. The user may press on the deflation plunger ring 112 until the inflation plunger tip 114 is at the end ofthe advancement . The balloon may then be d by fully retracting the deflation plunger 102. Once the n ofthe medical device is deflated, the deflation plunger 102 can be released and place back to neutral position.

Figures 3A and BB detail one unique aspect ofthe preferred embodiment; the pressure control mechanism incorporated in the design of the inflation plunger 103 which limits the maximum pressure being applied to the medical device. The m al pressure generated inside the distal portion of smaller syringe barrel 101"during the advancement ofthe inflation r 103 is d or regulated by the pressure control mechanism contained inside the inflation plunger housing 117. The pressure control mechanism is comprised ofthe face seal 118, pressure control piston 121 and pressure control spring 120. The maximum inflation pressure is determined or regulated by the degree or amount of compression force applied by the pressure control spring 120 to the pressure control piston 121 that presses the face seal 118 against the proximal face ofthe inflation plunger tip 1 14. Figure 3A shows the pressure control mechanism in a closed state, wherein the pressure in the smaller syringe barrel 101" distal to the on plunger seal 116 is below that ofa pre—determined value. Under these conditions, outlet port 119 is closed and there is no fluid and/or air flow path between the distal portion of smaller syringe barrel 101" and larger syringe barrel 101'. Figure BB illustrates the pressure control mechanism in the open state, wherein the internal pressure inside the distal portion of the smaller syringe barrel 101”exceeds a pre-determined value. In this state, the al pressure inside the distal portion of smaller syringe barrel 101"exceeds that ofthe pre-determined pressure exerted by the face seal 118 against the inflation plunger tip, compressing the pressure control spring 120 and moving face seal 118 proximally. The movement of face seal 188 opens a flow path at the contact ace between face seal 118 and inflation plunger tip 114. Further movement of the face seal 118 to a position proximal to outlet port 119 s a flow path between the distal portion of smaller syringe barrel 101”and larger syringe barrel 101’. The excess pressure inside the distal portion of smaller syringe barrel 101”is reduced as the on media flows through the outlet port 119, along the proximal portion ofsmaller syringe barrel 101”, and into larger syringe barrel 101’. When the internal pressure inside the distal portion of smaller syringe barrel 101" falls below the pre— determined level, compression spring 120 expands and applies force to pressure control piston 121, which in turn moves distally and re—establishes the ace between face seal 118 and the proximal face tion plunger tip 114. The value of the pre—determined pressure may be adjusted by changing the force constant of the compression spring 120, the resting length ofthe compression spring 120, the distance n outlet port 119 and the proximal edge ofinflation plunger tip 114, the static or dynamic on n the face seal and the internal surface of the inflation plunger housing 117, the static or dynamic friction between the pressure control piston 121 and the inflation plunger g 117, or the durometer offace seal 118 and/or pressure control piston 121 among other methods known in the art While the pressure l mechanism has been depicted as a spring and seal combination in this embodiment, other valve and/or seal mechanisms including but not limited to ball valves, duckbill valves, umbrella valves, check valves, diaphragms, shuttling valves, flap valves and the like may be incorporated into the mechanism.

Another unique aspect of the inflation/deflation e 100 of the invention is the capacity to both inflate and deflate the balloon of a medical device by PCT/U82012/020201 advancing or ting the coupled deflation plunger 102 and inflation plunger 103 aneously inside a ed or ated syringe barrel 101 that comprises two different diameters and/or s. Figure 4A illustrates a typical tandem syringe set up two sizes ofsyringe body are connected and arranged in series with the smaller syringe body 401 positioned distal to the larger syringe body 402. The syringe plunger 403 in such a system is sized to reside within the tandem syringe; this may be accomplished through the use ofa stepped design that has a smaller distal section 403" that matches the smaller syringe body 401 and a larger proximal section 403’ that matches the proximal syringe body 402 such that the syringe plunger 403 can translate along the length of the syringe body. In these types of systems, it is often not possible to generate a sufficiently high internal pressure inside the r syringe body 401(and in any medical equipment connected to the smaller syringe body). Once the distal plunger seal 404 engages and seals against the inside wall ofthe r syringe body chamber 401 (as shown in Figure 4B), the inflation fluid is trapped within the larger syringe body chamber. The incompressible inflation fluid trapped between distal r seal 404 and proximal plunger seal 405 then prevents the syringe plunger 403 from advancing further and increasing the re inside the smaller e body 401.

The unique design ofthe present ion illustrated in Figures 5A and SB allows the plungers 102 and 103 to be advanced further by incorporating a deflation plunger tip port 1 13 that allows the incompressible fluid trapped inside the larger syringe barrel 101’ to be displaced and transferred to the deflation plunger chamber 107. Figure 5A depicts the arrangement ofthe components ofthe invention at the point when the inflation plunger seal 116 initially contacts and seals against the inner wall of the smaller syringe barrel 101". The distal face of the piston 109 is in contact with the proximal face of the deflation plunger tip 104, closing the potential flow path through the on plunger tip port 113. Figure SB depicts the ement of the components of the invention after the syringe plungers 102 and 103 are further advanced distally. As syringe plungers 102 and 103 translate ly, the piston 109 and piston seal 108 assembly is pushed back proximally and the incompressible inflation fluid is directed through deflation plunger tip port 113 and transferred inside the deflation plunger chamber 107. The piston 109 and piston seal 108 assembly provides a leak free seal that keeps the inflation fluid inside the deflation plunger chamber 107. When the plungers 102 PCT/U52012/020201 and 103 are retracted for deflation (not shown), the ressible inflation fluid inside the deflation plunger chamber 107 is returned to smaller syringe barrel 101’ through deflation plunger tip port 113. The retraction ofsyringe plungers 102 and 103 creates a negative pressure inside the larger syringe barrel 101’. The negative pressure [with respect to the ambient pressure on the al side of the piston 109 and piston seal assembly 108] draws the inflation fluid into larger syringe barrel 101’ and pulls the piston 109 and piston seal 108 assembly distally within the deflation plunger chamber 107. The piston return spring 110 maintains the piston 109 in a normally biased position against the al face of deflation plunger tip 104 when the pressure in larger syringe barrel 101’ is less than that applied by the piston return spring 110 to the piston 109.

Yet another alternative configuration of the t invention is shown in Figure 6. Inflation/deflation syringe 600 comprises a syringe body 601, a deflation plunger 603, an inflation plunger 604, and movable plunger 606. As described r for syringe body 601, the syringe body 601 is comprised ofat least two integrated syringe barrels with at least two different cross sectional inner diameters, preferably oriented in series or tandem configuration. The syringe body 601 configuration in the red embodiment comprises ofa smaller volume e body (e.g. with a volume ty ofabout 1 ml), located in series and ably distal of the larger volume syringe body (eg. with a volume capacity equal to or greater than 5 ml]. The smaller volume e body is dimensioned to have a relatively small inner diameter and is used as the inflation r whereby the larger volume syringe body is dimensioned to have a larger inner diameter relative the smaller volume syringe barrel and is used as the deflation chamber as well as a reservoir for inflation fluid media such as air or liquid. Syringe body 601 also comprises at least one ring 602 or a similar feature, including but not limited to , indentations, wings, bars, grips, and the like, that may be used by the or to allow the syringe body to be single-handedly held. Deflation plunger 603 further comprises a deflation r tip, deflation plunger tip port, deflation plunger seal, and a deflation plunger chamber as described earlier for deflation plunger 103. Inflation plunger 604 further ses an inflation plunger tip, an inflation plunger tip port, an on plunger seal, an inflation plunger housing, a face seal, an outlet port, a pressure control spring, a pressure control piston, and an inflation rod as described earlier for inflation plunger 104. Deflation plunger 603 further comprises at least one ring 605 or a similar e, including but not limited to flanges, indentations, wings, bars, grips, and the like, that facilitate movement of deflation plunger 603 with respect to syringe body 601. Movable plunger 606 is slidably disposed within the lumen of deflation plunger 603 and comprises a gasket that provides an air and/or fluid tight seal n movable r 606 and the inner surface of deflation plunger 603 and at least one ring 607 or a similar feature, including but not limited to flanges, indentations, wings, bars, grips, and the like, that facilitate movement of movable plunger 606 with respect to syringe body 601 and/or deflation plunger 603. A return spring such as return spring 110 may or may not be present If present, the return spring would reside in the lumen of deflation plunger 603 and bias the distal tip ofthe movable plunger against the proximal face of the deflation plunger tip component of the deflation plunger 603.

Figures 7A-7C illustrate a method of using this composition of the ion.

Figure 7A depicts the inflation/deflation syringe 600 in a d state, wherein the inflation plunger 604, deflation plunger 603, and movable plunger 606 are retracted and the lumen ofthe syringe body 601 is filled with the on media.

The volume or amount ofinflation fluid drawn into the lumen ofthe syringe body 601 will correspond to the volume needed to fill the balloon and te high pressure within the balloon. A visual indicator (not shown) such as printed markers or the like, or a e indicator such as detents or the like, may be incorporated into the inflation/deflation syringe 600 to aid the user in filling the lumen ofthe syringe body 601 with the proper amount or volume ofinflation media. The distal end of e e 606 is seated t the distal wall of deflation plunger 603. Figure 7B depicts the state of the inflation/deflation syringe 600 as movable plunger 606 begins to advance in the distal direction, introducing the inflation media into an attached medical device (not shown], such as a balloon er. As the void volume of the medical device is filled with inflation media and the balloon begins to expand, the pressure in the balloon increases. High pressure inflation of the balloon is achieved by fully depressing the deflation plunger 603 and inflation plunger 604 as shown in Figure 7C. This may be done by grasping rings 602 and 605 and sliding ring 605 distally towards ring 602. Deflation ofthe balloon (not shown) may be accomplished by grasping rings 602 and 605 and sliding ring 605 ally until a ient vacuum is generated in the lumen of syringe body 601 such that the balloon is deflated in an appropriate length of time. The utility ofthis type of design configuration may be particularly useful when inflating a large balloon diameter and/or long balloon length where the volume ofinflation media required to fill the balloon prior to generating high pressure is more than the volume capacity of the small syringe commonly used to inflate and pressurize the balloon.

In yet r embodiment, the pressure control mechanism comprised of the face seal 118, pressure control piston 121, pressure control spring 120, along with the associated ents such as on plunger tip port 115, on plunger g 117 and outlet port 119 can be eliminated and replaced with a standard inflation plunger (not shown) and seal 116 configuration. In this uration, the internal pressure generated inside the smaller syringe barrel 101" is not limited. r, this internal pressure can be red by adding a pressure gage or indicator or sensor with indicator (not shown) at the distal end of the syringe body Where it is in communication with the inflation fluid path. The pressure gage or indicator set up is typically seen on standard inflation devices as described earlier. The difference between the device bed in this invention and that of a typical inflation device is the ability ofthe user to use a single hand to generate very high pressure inflation in a controlled manner. Very high inflation pressure as defined in this embodiment is that pressure in excess of4 atmospheres.

Together with the high pressure inflation capability, sufficient vacuum can be generated on the same device which facilitates rapid balloon deflation ofa medical Figures 8A-8B rate another embodiment of the invention.

Inflation/deflation syringe 800 is comprised ofa deflation e 801, an inflation syringe 802, a plunger 804, inflation syringe seal 805, port connector 825, and at least one grip 803. The distal end of the deflation syringe 801 is connected to a port in the sidewall ofinflation syringe 802. Deflation syringe 801 may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, PET, PEEK, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or combinations f, and may be transparent, translucent, opaque, or any gradient f. The on syringe 802 may be smaller (eg. with a volume capacity ofabout 1 ml) than the deflation syringe 801 (eg. with a volume capacity equal to or greater than PCT/U52012/020201 ml) and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, PET, PEEK, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or combinations thereof, and may be transparent, translucent, opaque, or any gradient thereof. The inflation e 802 may be dimensioned to have a relatively small inner diameter and is used as the on chamber whereby the deflation syringe 801 may be dimensioned to have a larger inner diameter relative to inflation syringe 802 and is used as the deflation chamber as well as a reservoir for inflation media such as air or liquid. While grip 803 is shown as a ring, it should be obvious that other features that enable and/or ease handling ofinflation/deflation syringe 800 may be freely interchanged with grip 803 ing, but not limited to flanges, cantilevers, overmolded components of ter different from that of on syringe 801 and inflation syringe 802, , triggers, wings, and the like. r 804 is sized such that deflation plunger 806 is coaxially disposed within deflation syringe 801 and inflation plunger 807 is coaxially disposed within inflation syringe 802. Port tor 825 may include but is not limited to fixed male or female luer lock fittings, rotating male or female luer lock fittings, hose barbs, slip luers, quick release fittings, and the like. In place of a port connector 825 provided at the distal end ofthe inflation syringe 802, an extension line or tubing (not shown) may be permanently attached to the distal end of the inflation siring 802 and the port connector 825 may attached to the distal end of the extension line (not: shown).

As shown in , plunger 804 comprises a deflation r 806, and inflation plunger 807, grip 808, and pressure release port 809. Deflation plunger 806 further comprises deflation plunger tip 812, deflation r tip port 813, deflation plunger seal 811, deflation plunger chamber 816, piston seal 814, piston 810, and piston return spring 815. Deflation plunger 806 is sized to fit coaxially within deflation syringe 801 and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, PET, PEEK, ess steel, brass, aluminum, titanium, borosilicate glass, cs, and the like or combinations thereof, and may be transparent, translucent, , or any gradient f. on plunger tip 812 is joined to the distal end of deflation plunger 806 by methods known in the art including, but not limited to press fitting, adhesive bonding, ultrasonic welding, threading/tapping, overmolding, heat fusing, use of a set screw, and the like and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, ethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone , nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, PTFE, stainless steel, brass, um, titanium, borosilicate glass, ceramics, and the like or combinations thereof.

Furthermore, deflation plunger tip 812 and deflation plunger 806 may be integrated and made as single component by means of commonly known fabrication techniques such as machining, injection g, blow molding, casting, and the like or ations thereof. Deflation plunger tip 812 further comprises at least one deflation plunger tip port 813. Deflation plunger tip port 813 may be fabricated using methods known in the art including, but not limited to laser cutting and or engraving, mechanical machining, electrical discharge machining, chemical etching, and the like. Alternatively, deflation plunger tip port 820 may be formed in on plunger tip 812 as a feature of deflation plunger tip 812 during a g process. Deflation plunger seal 811 is sized and arranged such that it provides an air and/or fluid tight seal n the deflation plunger tip 812 and the inner surface of deflation syringe 801 and may be fabricated from materials including, but not limited to polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, polyethylene, and the like. While deflation plunger seal 811 is depicted as an o-ring in , it should be clear to those ofskill in the art that lent components such as gaskets may be interchanged with deflation plunger seal 811. For example, deflation seal 811 may be an integral part of deflation plunger tip 812, such as one or more flanges molded, machined, or otherwise manufactured as a feature of deflation plunger 812 that provides an air and/or liquid tight seal between deflation plunger tip 812 and the inner surface of deflation syringe 8O 1. Piston 810 coaxially resides within deflation r chamber 816 and may be ated from materials known in the art including, but not limited to polycarbonate, opylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl , natural rubber, PTFE, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or ations thereof. Piston 810 is biased by return spring 815 such that the distal face ofpiston 810 is positioned against the proximal face of deflation plunger tip 812. Piston seal 814 PCT/U52012/020201 may be held within a feature such as a groove or channel on piston 810, and is sized such that it creates an air and/or liquid tight seal between piston 810 and the inner surface of deflation plunger 806 while ng translation of piston 810 along deflation plunger chamber 816 and may be fabricated from materials including, but not limited to loroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, l rubber, polyethylene, and the like. While piston seal 814 is depicted as an o-ring in , it should be clear to those of skill in the art that equivalent components such as gaskets maybe interchanged with piston seal 814. For example, piston seal 814 may be an al part ofpiston 810, such as one or more flanges molded, machined, or otherwise manufactured as a feature ofpiston 810 that provides an air and/or liquid tight seal between piston 810 and the inner surface of deflation r 806. Piston return spring 815 resides within deflation plunger chamber 816, and has a combination of spring rate, length, pitch, wire thickness, and outer diameter such that the distal end of piston return spring 815 places a compressive load against the piston 810. Piston return spring 815 may be fabricated from materials known in the art ing but not d to high carbon wire, alloy steel, stainless steel, nitinol, non-ferrous alloy, emperature alloy, and the like. Pressure e port 809 is ed to prevent pressure build up inside the deflation plunger chamber 816 when the piston 810 moves proximally.

Inflation plunger 807 further comprises inflation plunger tip 823, inflation plunger tip port 822, inflation r seal 821, inflation plunger g 817, face seal 824, outlet port 820, pressure control spring 818, and pressure control piston 819. Inflation plunger housing 817 is joined to the distal end of inflation plunger 806 using methods known in the art including, but not limited to press fitting, adhesive bonding, ultrasonic welding, threading/tapping, overmolding, heat fusing, use ofa set screw, and the like and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, polyurethane, nylon, Pebax, PET, PEEK, ®, polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, PTFE, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or combinations thereof. Alternatively, inflation plunger housing 817 and inflation plunger 806 may be machined, molded, or otherwise formed as a single integrated component. Inflation plunger g 817 further comprises outlet port 820. Outlet port 820 may be fabricated using methods known PCT/U82012/020201 in the art including but not limited to laser cutting and or engraw'ng, ical machining, electrical discharge machining, chemical etching, and the like.

Alternatively, outlet port 820 may be formed in inflation plunger housing 817 as a feature ofinflation plunger housing 817 during a molding process. Inflation plunger tip 823 is joined to the distal end ofinflation plunger housing 817 using methods known in the art including, but not limited to press fitting, adhesive bonding, ultrasonic g, ing/tapping, overmolding, heat fusing, use ofa set screw, and the like and may be fabricated from materials known in the art including, but not d to polycarbonate, polypropylene, polymethylmethacrylate, ethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural , PTFE, stainless steel, brass, aluminum, titanium, borosilicate glass, ceramics, and the like or combinations thereof. Inflation plunger tip 823 further comprises at least one inflation port 822 extending from the distal to proximal ends of inflation plunger tip 823, and may be fabricated using methods known in the art including, but not limited to laser cutting and or engraving, mechanical ing, electrical discharge machining, chemical etching, and the like. atively, inflation port 822 may be formed in inflation plunger tip 823 as a e of inflation plunger tip 823 during a molding process. Inflation plunger seal 821 may be held within a feature such as a groove or channel on inflation plunger tip 823, and is sized such that it creates an air and/0r liquid tight seal between inflation plunger tip 823 and the inner surface ofinflation syringe 802 and may be ated from materials including, but not limited to polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, polyethylene, and the like.

While inflation plunger seal 821 is depicted as an o-ring in , it should be clear to those of skill in the art that equivalent components such as gaskets may be interchanged with inflation r seal 821. For example, inflation plunger seal 821 may be an integral part tion plunger tip 823, such as one or more flanges molded, ed, or otherwise manufactured as a feature of inflation plunger tip 823 that provides an air and/or liquid tight seal between inflation plunger tip 823 and the inner surface of inflation syringe 802. Face seal 824 resides inside inflation plunger housing 817 and is sized to provide an air and/or fluid tight seal when pressed against the proximal end ofthe inflation plunger tip 823. Face seal 824 may be ated from materials known in the art ing, but not limited to polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber and the like. Pressure control piston 819 coaxially s within on plunger housing 817 and may be fabricated from materials known in the art including, but not limited to polycarbonate, polypropylene, polymethylmethacrylate, ethane, nylon, Pebax, PET, PEEK, Delrin®, polychloroprene, silicone rubber, nitrile rubber, Viton®, EPDM, butyl rubber, natural rubber, PTFE, stainless steel, brass, um, titanium, borosilicate glass, ceramics, and the like or combinations thereof. Pressure control piston 819 is biased by re control spring 818 such that the distal face of pressure l piston 819 contacts the proximal surface of face seal 824. Pressure control piston 819 may be joined to face seal 824 or the two components may be decoupled from each other. Methods ofjoining the two components may comprise, but are not d to press fitting, adhesive bonding, ultrasonic welding, threading/tapping, overmolding, use ofa set screw, and the like. Alternatively, pressure control piston 819 and face seal 824 may be manufactured as a single unit. The proximal end of pressure control piston 819 serves as a base to stabilize the distal end of pressure control spring 818. Pressure control spring 818 resides within inflation plunger g 817 such that the distal end ofpressure control spring 818 places a compressive load on pressure control piston 819. Pressure control piston 819 transmits at least some ofthe compressive load applied by pressure control spring 818 to the proximal surface of face seal 824, thus maintaining a seal between inflation plunger tip 823 and the distal surface offace seal 824. Pressure control spring 818 maintains this seal until a desired pressure is exceeded; this pressure is dictated by the force (or spring force constant) of re control spring 818 at a given length of compression by specifying the overall length, pitch, wire thickness, wire material and outer diameter of re control spring 818. re control spring 818 may be fabricated from materials known in the art including, but not limited to high carbon wire, alloy steel, ess steel, l, rrous alloy, high-temperature alloy, and the like.

While grip 808 is shown as a ring, it should be obvious that other features that enable and/or ease handling ofinflation/deflation syringe 800 may be freely interchanged with grip 808 including, but not limited to flanges, cantilevers, overmolded components of durometer different from that ger 804, ridges, triggers, wings, and the like that may be used by the operator to allow the on/deflation syringe 800 to be held with a single hand and provide stability when advancing or ting the plunger 804.

The pressure l mechanism ofthe ment ofthe invention shown in s 8A and 83 provides the same function as that described in s 3A and 3B. Similarly, while the pressure control mechanism has been depicted as a spring and seal combination in this embodiment, other valve and/or seal mechanisms including but not limited to ball valves, duckbill valves, umbrella , check valves, diaphragms, shuttling valves, flap valves and the like may be incorporated into the mechanism.

The design ofthe inflation/deflation syringe 800 allows inflation media inside the deflation syringe 801 to be displaced and transferred to the deflation plunger chamber 816. As plunger 804 translates distally and the pressure within deflation syringe 801 exceeds a pre-set value, the piston 810 and piston seal 814 assembly is pushed back proximally and the inflation media is directed through deflation plunger tip port 813 and into deflation plunger chamber 816. The piston 810 and piston seal 814 assembly provides a leak free seal that keeps the inflation fluid inside the deflation plunger chamber 816. When the plunger 804 is retracted for deflation the inflation media inside the deflation plunger chamber 816 is returned to on syringe 801 h deflation plunger tip port 813. The tion of e plunger 804 creates a negative pressure inside the deflation syringe 80 1. The negative pressure (with respect to the ambient pressure on the proximal side ofthe piston 810 and piston seal 814) draws the inflation media into deflation syringe 801 and pulls the piston 810 and piston seal 814 assembly distally within the deflation r chamber 816. The piston return spring 815 maintains the piston 810 in a normally biased position against the proximal face of deflation plunger tip 812 when the pressure in deflation syringe 801 is less than that applied by the piston return spring 815 to the piston 810.

Alternatively (not shown), deflation plunger seal 811 and inflation plunger seal 821 may reside on a channel, , or similar feature of deflation syringe 801 and on syringe 802, respectively, that allows for hermetic seals between deflation syringe 801 and deflation plunger 806, and inflation syringe 802 and inflation plunger 807. In this embodiment, the outlet port 820 is positioned or located al ofthe inflation plunger seal 821 when the plunger 804 is fully PCT/U52012/020201 depressed into deflation syringe 801 and inflation syringe 802. The outlet port 820 may be incorporated to the inflation rod 807 by way of providing an inner lumen or opening (not shown) through the length ofinflation rod 807 originating from the distal end and terminating at the proximal end ofthe inflation rod 807.

Alternatively, the location of inflation r housing 817, face seal 824, pressure control spring 818, and pressure control piston 819, may be positioned proximally (not shown) by increasing the length ofthe inflation plunger tip 823 and decreasing the length ofthe inflation rod 807, thus shifting the outlet port 820 proximal ofthe inflation plunger seal 821 when the plunger 804 is fully depressed into deflation syringe 801 and inflation syringe 802.

Figure. 9A-9C illustrate a method of the using one embodiment of the inflation/deflation syringe ofthe invention. The on/deflation syringe 800 can be used to inflate and deflate an inflatable element [not shown) of a l device such as balloon er (not shown) and the like. Figure 9A shows the relative position ofthe elements of the components of the invention when inflation media has been fully drawn into the deflation syringe 801 and inflation syringe 802.

Excess inflation media and/or air or air bubbles above the media level inside the deflation syringe 801 and inflation syringe 802 can be purged out by ing the plunger 804, while the syringe 800 is held vertically. A visual tor (not shown) such as printed markers or the like, or a tactile indicator such as detents or the like, may be incorporated into the inflation/deflation syringe 800 to aid the user in filling the lumens ofthe deflation syringe 801 and/or inflation syringe 802 with the proper amount or volume ofinflation media. The port connector 825 may then be attached to the medical device inflation port. Alternatively, an inflation line ion [not shown) may be attached to the port tor 825 prior to purging the excess inflation media. Once the inflation line extension is connected, excess inflation media and/or air or air bubbles above the fluid level inside the deflation e 801 and inflation syringe 802 can be purged out by advancing the plunger 804, while the syringe 800 is held ally. At this point, the inflation line lumen (not shown) should be filled with inflation media and the distal end ofthe extension line can be attached to a medical device such as a balloon catheter, for example. A balloon catheter, for e, may be prepared by aspirating the air out ofthe balloon inflation path by fully retracting the plunger 804 and allowing the air/air bubbles to be purged out (not . This is done by g the syringe 800 such PCT/U82012/020201 that the distal up is pointed down prior to retracting the plunger 804 and then releasing to neutral. Figures BB and 8C show the uent one-handed inflation of the balloon catheter. The user may advance grip 808 distally until the plunger 804 is at the end ofthe advancement stroke. The balloon may then be deflated by fully retracting the plunger 804. Once the n of the l device is deflated, grip 808 can be released return plunger 804 to a l (equilibrated pressure) position.

In yet r embodiment ofinflation/deflation syringe 800, the pressure control mechanism comprised ofthe face seal 820, re control piston 819, pressure control spring 818, along with the associated components such as inflation plunger tip port 822, inflation r housing 817 and outlet port 820 can be eliminated and replaced with a standard inflation plunger (not shown) and seal 821 configuration. In this configuration, the internal pressure generated inside the inflation syringe 802 is not limited. However, this al pressure can be monitored by adding a pressure gage or indicator or sensor with indicator (not shown) at the distal end ofthe syringe body where it is in communication with the inflation fluid path. The pressure gage or indicator set up is typically seen on standard on s as described earlier. The ence n the device described in this invention and that of a typical inflation device is the ability ofthe user to use a single hand to generate very high pressure inflation in a controlled manner. Very high inflation pressure as defined in this embodiment is that pressure in excess of 4 atmospheres. Together with the high pressure inflation capability, sufficient vacuum can be generated on the same device which facilitates rapid balloon deflation of a medical device.

Furthermore (not shown), the inflation/deflation syringes 100, 600, and 800 may comprise locking mechanisms known in the art that can be engaged or disengaged, such as those taught in US. Pat. No. 5,215,536 and herein orated in full by reference, between the syringe plungers and syringe barrels that allow or enable a desired pressure or vacuum to be maintained within inflation/deflation syringes 100, 600, and 800.

In yet another embodiment of this invention, on/deflation syringes 100, 600, and 800 may be used to deliver a low volume ofinflation media in a controlled manner. This may have application in the inflation of a low pressure PCT/U52012/020201 balloon, for example. In this use, a graduation or marking on the syringe body may be aligned with a feature on the inflation and/or deflation plungers to signal the ry of an appropriate volume of inflation media.

The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements, which, gh not itly described or shown herein, embody the principles of the invention, and are included within its spirit and scope. Furthermore, all examples and ional language recited herein are pally intended to aid the reader in understanding the principles ofthe invention and the concepts contributed by the inventors to furthering the art, and are to be ued as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the , i.e., any elements developed that perform the same function, regardless of structure.

The scope ofthe present ion, therefore, is not intended to be d to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims. 2443

Claims (27)

1. An inflation/ deflation syringe that generates pressure or delivers a lled volume, comprising: a syringe barrel comprising multiple chambers of multiple diameters; a syringe plunger comprising multiple diameters sized to fit within the syringe barrel, wherein a syringe r segment of largest diameter is hollow and in fluid communication with the largest diameter segment of the syringe ; and a piston and/or seal disposed and ically sealed within an inner chamber of the 10 e plunger segment of largest diameter.

2. The inflation/deflation syringe of claim 1, wherein the e barrel comprises two chambers of different diameters and the syringe plunger comprises two segments of different diameters.

3. The inflation/deflation syringe of either one of claims 1 or 2, wherein all chambers of the 15 syringe barrel are ly connected in serial and/or parallel arrangements.

4. The inflation/deflation syringe of any one of the preceding claims, wherein at least one chamber of the e barrel is remotely connected and in serial and/or parallel arrangement with a second chamber of the syringe barrel.

5. The inflation/deflation syringe of any one of the preceding claims, wherein the syringe 20 barrel chamber of smallest volume has a smaller inner er than the inner diameter of the syringe barrel chamber of largest volume.

6. The on/deflation syringe of any one of the preceding claims, wherein the smallest diameter syringe plunger segment is directly connected to and in serial or parallel arrangement with the largest syringe plunger segment. 25

7. The inflation/deflation syringe of any one of the preceding claims, wherein each syringe plunger segment comprises a g member. 1000712443

8. The on/deflation syringe of claim 7, wherein the sealing member is located at the distal end of each syringe plunger segment.

9. The on/deflation syringe of any one of the preceding claims, wherein each syringe barrel chamber ses a sealing member.

10. The inflation/deflation syringe of any one of the preceding claims, n the syringe plunger segments move in .

11. The inflation/deflation syringe of any one of the preceding claims, wherein the smallest diameter syringe plunger segment comprises a pressure regulating or limiting mechanism.

12. The inflation/deflation syringe of any one of the preceding claims, wherein a pressure 10 gage or pressure monitoring indicator is connected to the distal end of the small volume syringe barrel.

13. The inflation/deflation syringe of any one of the preceding claims, n the syringe barrel chamber with the smallest volume, in ction with the syringe plunger t of smallest diameter, provides high pressure inflation or controlled volume delivery. 15

14. The inflation/deflation e of any one of the preceding claims, wherein syringe barrel chamber of largest volume provides vacuum and/or a reservoir for inflation media.

15. The inflation/deflation syringe of claim 14, further comprising a media release port in largest diameter syringe plunger segment.

16. The inflation/deflation syringe of any one of the preceding claims, n the inflation 20 media is gas and/or .

17. The inflation/deflation syringe of any one of the preceding claims, wherein the high pressure inflation or a controlled volume delivery can be generated using a single hand and the syringe plunger can be retracted post inflation or post controlled volume delivery using a single hand. 25

18. The inflation/deflation syringe of any one of the preceding claims, wherein the inflation/deflation syringe may be locked to maintain a desired inflation pressure. 1000712443

19. The inflation/deflation syringe of any one of the preceding claims, wherein the inflation/deflation syringe may be locked to maintain a d deflation pressure or vacuum.

20. The inflation/deflation syringe of any one of the preceding claims, wherein the piston and/or seal disposed and hermetically sealed within the inner chamber of the syringe plunger of largest diameter is biased towards the distal end of the inner chamber of the syringe plunger of largest diameter under neutral re.

21. The inflation/deflation syringe of any one of the preceding claims, further comprising at least one marker to te a desired fill volume of inflation media.

22. The inflation/deflation syringe of claim 1 for controlled pressure delivery of fluids, 10 wherein: the syringe barrel comprises two chambers of unequal volume ted in series, wherein a smaller volume chamber is connected distal of and in communication with a larger volume chamber; and the syringe plunger comprises two segments of unequal diameter, wherein a r 15 diameter segment is sized to fit within the smaller volume r of the syringe barrel and the syringe plunger segment of largest diameter is sized to fit within the larger volume chamber of the syringe barrel; wherein the r diameter syringe r segment ses a pressure ting or limiting mechanism; 20 n the inner chamber of the syringe plunger segment of largest diameter is hollow, elongate and in fluid communication with the larger volume chamber of the syringe barrel; wherein the piston and/or seal is disposed within the elongate inner chamber of the syringe plunger segment of largest diameter and provides a hermetic seal against an inner surface ofthe elongate inner chamber of the syringe plunger segment of the largest diameter; 25 wherein the smaller diameter syringe plunger segment ses a sealing member disposed on a distal n of the smaller diameter syringe r segment that provides a 1000712443 ic seal between the smaller diameter syringe plunger and an inner surface of the smaller volume chamber of the syringe ; and wherein the syringe plunger segment of largest diameter comprises a sealing member disposed on a distal portion of the syringe plunger t of largest diameter that provides a hermetic seal between the syringe plunger segment of largest diameter and an inner surface of the larger volume chamber of the syringe .

23. The inflation/deflation syringe of claim 22, wherein the larger volume chamber of the syringe barrel provides a reservoir for fluid media.

24. The inflation/deflation syringe of claim 1 for controlled re delivery of fluids, 10 wherein: the syringe barrel comprises two chambers of unequal volume connected in series, wherein a r volume chamber is connected distal of and in communication with a larger volume chamber; and the e plunger comprises two segments of l diameter, wherein a smaller 15 diameter segment is sized to fit within the smaller volume chamber of the syringe barrel and the syringe plunger segment of largest diameter is sized to fit within the larger volume chamber of the syringe barrel; wherein the smaller diameter syringe plunger segment comprises a pressure regulating or limiting mechanism; 20 n the inner chamber of the syringe plunger segment of largest diameter is hollow, elongate and in fluid communication with the larger volume chamber of the syringe barrel; wherein the piston and/or seal is disposed within the elongate inner chamber of the syringe plunger segment of largest diameter and provides a hermetic seal against an inner surface of the elongate inner chamber of the syringe plunger segment of largest diameter; 25 wherein the r volume chamber of the syringe barrel ses a sealing member that provides a hermetic seal between the smaller diameter segment of the syringe plunger and an inner surface of the smaller volume chamber of the syringe barrel; and wherein the larger volume chamber of the syringe barrel ses a sealing member that provides a hermetic seal between the syringe r segment of largest diameter and an inner surface of the larger volume chamber of the e barrel.

25. The inflation/deflation syringe of claim 24, wherein the larger volume chamber of the syringe barrel provides a reservoir for fluid media.

26. The inflation/deflation syringe of claim 1 for controlled volume delivery of fluids, the syringe barrel comprises two chambers of unequal volume connected in series, wherein a smaller volume chamber is ted distal of and in communication with a larger 10 volume r; and the syringe plunger comprises two segments of unequal diameter, wherein a smaller diameter segment is sized to fit within smaller volume chamber of the syringe barrel and the e plunger segment of largest diameter is sized to fit within the larger volume chamber of the syringe barrel; 15 wherein the inner chamber of the syringe plunger segment of largest diameter is hollow, elongate and in fluid communication with the larger volume chamber of the syringe barrel; and wherein the piston and/or seal is disposed within the elongate inner chamber of the syringe plunger segment of largest diameter and es a ic seal against an inner surface of the elongate inner chamber of the syringe plunger segment of largest diameter. 20

27. The inflation/deflation e of claim 26, wherein the larger volume chamber of the syringe barrel provides a reservoir for fluid media.