HIGH PRESSURE INFLATION DEVICE

Inflation devices and methods used to inflate a balloon of a balloon catheter are disclosed. The inflation devices include a pressure member to contain a fluid to be pressurized. The pressure member includes a load transfer orifice configured to receive a load transfer member of a threaded insert. The load transfer member can transfer an axial load applied to the threaded insert during pressurization of the fluid to the pressure member. A plunger including a thread rail is slidingly disposed within the pressure member. The thread rail is engaged with the threaded insert when the fluid is pressurized. An actuator disengages the thread rail from the threaded insert to depressurize the fluid.

TECHNICAL FIELD

The present disclosure relates generally to devices used to pressurize, depressurize, or otherwise displace fluid, particularly in medical devices. More specifically, the present disclosure relates to high-pressure devices used to pressurize, depressurize, or otherwise displace fluid along a fluid line in order to inflate or deflate a medical device, such as a balloon.

DETAILED DESCRIPTION

In certain instances, an inflation device is in fluid communication with a balloon disposed at an end of a catheter. The inflation device may be used to generate a high pressure to inflate the balloon for a variety of medical procedures. For example, the inflation device can be used to widen a stricture of a vessel or passage, expand a stent within a vessel or passage, or occlude a vessel or passage.

The inflation device may include a syringe that utilizes threads to advance or retract a plunger by rotating the plunger relative to the body of the syringe such that the threads cause longitudinal displacement of the plunger relative to the body. In some instances, an inflation device may further include retractable threads, enabling a practitioner to disengage the threads and displace the plunger by simply pushing or pulling the plunger. The inflation device may comprise a threaded insert configured to constrain movement of the plunger within the syringe body. The threaded insert may comprise threads configured to engage with the retractable threads.

An embodiment of an inflation device within the scope of this disclosure includes a pressure member having a load transfer orifice. A threaded insert is coupled to the pressure member. The threaded insert includes a load transfer member that is disposed within the load transfer orifice and internal threads. A plunger is slidingly disposed within the pressure member and includes a thread rail selectively coupled to the threaded insert. The thread rail includes threads to engage with the threads of the threaded insert and protrusions. A plunger tip is operably coupled to a distal end of the plunger. An actuator includes a guide member coupled to the thread rail. The guide member includes ramps and slots configured to engage with the protrusions of the thread rail.

When the inflation device disclosed within this disclosure is pressurized to inflate a balloon, the protrusions of the thread rail engage the ramps of the guide member causing the threads of the thread rail to engage with the threads of the threaded insert. A handle of the actuator is rotated by a user causing the plunger tip to be displaced distally and pressurize fluid within the pressure member. An axial load applied to the threads is transferred to the pressure member through the load transfer member of the threaded insert and the load transfer orifice of the pressure member. When the inflation device is depressurized to deflate the balloon, the handle of the actuator is moved distally relative to the plunger causing the protrusions to be disposed in the slots of the guide member. This allows the thread rail to be radially inward displaced and the threads of the thread rail to disengage from the threads of the threaded insert. The disclosed embodiment of the inflation device allows the inflation device to be pressurized to a high pressure while reducing a force needed for activation of depressurization.

FIGS.1-3illustrate different views of an embodiment of an inflation device.FIG.4illustrates an embodiment of a fluid reservoir of the inflation device.FIGS.5Aand illustrate an embodiment of a plunger tip of the inflation device.FIG.6illustrates an embodiment of a threaded insert of the inflation device.FIG.7illustrates the threaded insert coupled to the fluid reservoir.FIG.8illustrates an embodiment of a grip of the inflation device.FIGS.9A-9Cillustrate an embodiment of a plunger of the inflation device.FIG.10Aillustrates the plunger and the threaded insert in an engaged state.FIG.10Billustrates the plunger and the threaded insert in a disengaged state.FIGS.11A and11Billustrate an embodiment of an actuator of the inflation device.FIG.12Aillustrates the inflation device in a pressurization state.FIG.12Billustrates the inflation device in a depressurization state. In certain views each device may be coupled to, or shown with, additional components not included in every view. Further, in some views only selected components are illustrated, to provide detail into the relationship of the components. Some components may be shown in multiple views, but not discussed in connection with every view. Disclosure provided in connection with any figure is relevant and applicable to disclosure provided in connection with any other figure or embodiment.

FIG.1illustrates an embodiment of an inflation device100. As illustrated inFIG.1, the inflation device100can include three broad groups of components; each group may have numerous subcomponents and parts. The three broad component groups are: a pressure member110, a plunger150, and an actuator170.

FIGS.2and3illustrate the embodiment of the inflation device100. As illustrated, the pressure member110may include a fluid reservoir111, a plunger tip120slidingly disposed within the fluid reservoir111, a threaded insert130coupled to the fluid reservoir111, and a grip140coupled to an exterior of the fluid reservoir111. Further, as illustrated inFIG.2, the plunger150may include a trigger grip151and a thread rail154extending distally from the trigger grip151. Further still, as illustrated inFIG.2, the actuator170can include a handle171, a plunger guide member172extending distally from the handle171, and a compliant member177disposed around the plunger guide member172.

FIG.4illustrates an embodiment of the fluid reservoir111of the pressure member110. As illustrated in the embodiment, the fluid reservoir111can include a cylindrical shape that defines a pressure chamber119. The pressure chamber119may have a diameter ranging from about 15.2 millimeters to about 30.5 millimeters and may be about 16.3 millimeters. The fluid reservoir111may be formed of a rigid material capable of withstanding a high pressure without fracturing or deforming. For example, the fluid reservoir111can be formed of polycarbonate, glass, metal, copolyester, nylon, cyclic olefin polymer, or cyclic olefin copolymer. Other materials are contemplated. A nozzle113may be disposed at a distal end and may be in fluid communication with the pressure chamber119. In some embodiments, the nozzle113is a male Luer fitting. The nozzle113can be configured to couple an inflatable medical device to the fluid reservoir111. Fluid from the pressure chamber119can flow through the nozzle113and into the inflatable medical device causing the inflatable medical device to inflate. Fluid can also flow from the inflatable medical device through the nozzle113and into the pressure chamber119allowing the inflatable medical device to deflate. In certain embodiments, the inflatable medical device is a balloon.

A pair of longitudinal flex members115may be disposed at a proximal end of the fluid reservoir111. Slots116can be disposed between the flex members115to allow the flex members115to deflect radially inward and outward. A load transfer orifice114can be disposed in each of the flex members115. The load transfer orifice114may be sized and shaped to receive a load transfer member of the threaded insert130, as will be described below. The flex members115can flex radially outward over the threaded insert130when the threaded insert130is coupled to the fluid reservoir111. One or more longitudinal ribs117may be disposed adjacent the flex members115. The rib117can prevent rotation of the grip140relative to the fluid reservoir111.

Optionally or alternatively, a pressure gage112can be coupled to the fluid reservoir111such that the pressure gage112is in fluid communication with the pressure chamber119. The pressure gage112may be of any suitable type to measure a fluid pressure within the fluid reservoir111. For example, the pressure gage112can be an analog pressure gage or a digital pressure gage. Other types of pressure gages are contemplated.

FIGS.5A and5Billustrate an embodiment of the plunger tip120. As illustrated inFIGS.5A and5B, the plunger tip120can include a body121having a cylindrical shape. The plunger tip120may be formed of any suitable material, such as polycarbonate, high density polyethylene, polypropylene, acrylonitrile butadiene styrene, nylon, polyoxymethylene, polysulfone, polyetheretherketone, etc. In some embodiments, the materials may be reinforced or filled with a filler, such as glass. A circumferential channel122can be disposed adjacent a distal end126. An O-ring129may be disposed within the channel122to create a seal between the body121and an interior surface of the fluid reservoir111. The distal end126may be concave to reduce air bubbles within the fluid reservoir111to allow for easier removal of air bubbles from the fluid reservoir during priming of the inflation device100. For example, a transition angle from the distal end126to the interior surface of the fluid reservoir111can be greater than 90 degrees to substantially prevent air bubbles from being trapped between the distal end126and the interior surface of the fluid reservoir111. A bore127can be open at a proximal end128and closed at the distal end126. An engagement member125may be disposed within the bore127to engage a distal end of the thread rail154. The engagement member125can include a proximal face oriented perpendicular to a longitudinal axis of the body121. A coupling pin123may be disposed through a pin hole124disposed adjacent the proximal end128to operatively couple the thread rail154to the plunger tip120. The coupling pin123can be a spring pin or any other suitable type of pin.

FIG.6illustrates an embodiment of the threaded insert130. As illustrated, the threaded insert130can include a cylindrical body131having a bore136therethrough. The threaded insert130may be formed of rigid or semi-rigid polymeric material. For example, the material can be polycarbonate, high density polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyetheretherketone or polyoxymethylene. In some embodiments, the materials may be reinforced or filled with a filler, such as glass. Other materials are contemplated. The bore136may include female helical insert threads132extending along a length of the bore136. The insert threads132may include either a single start or a double start. A load transfer member133may be disposed on opposing sides of an exterior surface of the body131. The load transfer member133can have an arcuate shape to transfer an axial load from the threaded insert130to the pressure member110. In other embodiments, the load transfer member133can include any other suitable shape. Further, a slot feature134can be disposed on the exterior surface of the body131between the load transfer members133.

FIG.7illustrates the threaded insert130coupled to the fluid reservoir111. As illustrated, the threaded insert130can be disposed within the fluid reservoir111with the load transfer member133disposed within the load transfer orifice114. The slot feature134may be disposed within the slot116to guide the threaded insert130into the fluid reservoir111. The load transfer member133may include a ramp138to facilitate disposing of the load transfer member133within the load transfer orifice114. The ramp138can deflect the flex member115radially outward as the threaded insert130is inserted into the fluid reservoir111.

FIG.8illustrates an embodiment of the grip140. As illustrated, the grip140can include a body141having a bore142extending therethrough. The body141may be formed of a rigid or semi-rigid material, such as polycarbonate, polyethylene, polypropylene, polyurethane, acrylonitrile butadiene styrene, nylon, polyoxymethylene, or thermoplastic elastomer. Other materials are contemplated. A longitudinal channel143can be disposed within the bore142to receive the rib117of the fluid reservoir111. When the rib117is disposed within the channel143, the grip140is prevented from rotating relative to the fluid reservoir111. The grip140may have an ergonomic shape or surface to allow a user to grasp the grip140in a hand to prevent the fluid reservoir111from rotating when the actuator170is rotated. For example, in the illustrated embodiment, the grip140includes lobes144to provide an ergonomic grasping shape. In other embodiments, an exterior surface of the grip140can include bumps, divots, ribs, knurls, texturing, or a compliant material. Other ergonomic shapes and surfaces are contemplated within the scope of this disclosure.

FIGS.9A-9Cillustrate an embodiment of the plunger150. As illustrated, the plunger150can include a trigger grip151and a thread rail154. The plunger150may be formed of a rigid or semi-rigid material, such as polycarbonate, high density polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyetheretherketone or polyoxymethylene. In some embodiments, the materials may be reinforced or filled with a filler, such as glass. Other materials are contemplated. The trigger grip151may include a graspable shape, including finger grips, to be grasped by fingers of the user. A proximal plunger ramp152can be disposed adjacent a proximal end of the trigger grip151to interface with a proximal actuator ramp of the actuator170, as will be discussed below. Longitudinal ribs153can be disposed on an exterior surface of the trigger grip151to maintain axial alignment of the trigger grip151with the handle171when the handle171is displaced over the trigger grip151.

The thread rail154can extend distally from the trigger grip151. As illustrated, the thread rail154may include a first rail160and a second rail161that extend parallel to each other. A channel162is disposed between the rails160,161. Each of the rails160,161can include protrusions156,164respectively, extending downward from the rails160,161. The protrusions156of the first rail160may be separated by gaps163and the protrusions164of the second rail161may be longitudinally separated by gaps165. Further, the protrusions156of the first rail160can be longitudinally offset relative to the protrusions164of the second rail161. In other words, as shown inFIG.9C, a transverse cross-section of the thread rail154through section9B-9B shows the protrusion156of the first rail160transversely aligned with a gap165of the second rail161.

A distal plunger ramp157may be disposed adjacent a distal end159of the thread rail154to be engaged by a distal actuator ramp of the actuator170, as will be discussed below. A pin passage158can be disposed through the thread rail154adjacent the distal end159to receive the coupling pin123of the plunger tip120. The distal end159can include a flat head166to press against the engagement member125of the plunger tip120when the plunger150is displaced distally to pressurize the fluid reservoir111. Further, the flat head166can slidingly interface with the engagement member125when the thread rail154is disengaged from the threaded insert130.

The thread rail154can include male plunger threads155disposed along a length of the thread rail154to selectively engage with the insert threads132of the threaded insert130. The plunger threads155may include an arc length of from about 45 degrees to about 60 degrees and may be about 52 degrees.

FIGS.10A and10Billustrate two operable positions of the thread rail154with respect to the threaded insert130.FIG.10Ashows the thread rail154disposed in an engaged position, such that the plunger threads155are engaged with the insert threads132.FIG.10Bshows the thread rail154in a disengaged position, wherein the thread rail154is sufficiently retracted into the threaded insert130that the plunger threads155are not engaged with the insert threads132.

Each of the insert threads132include a proximal flank132aand a distal flank132b. Each of the plunger threads155include a proximal flank155aand a distal flank155b. The proximal flanks132a,155aare configured to engage when the plunger150is threaded into the threaded insert130. In the illustrated embodiment, the proximal flank155aof the plunger threads155and the proximal flank132aof the insert threads132include an engagement angle β that may range from about 45 degrees to about 90 degrees and from about 70 degrees to about 80 degrees. A pitch of the threads132,155can range from about 8 threads per inch to about 16 threads per inch. A height of the threads132,155may range from about 0.040 inches to about 0.100 inches. With the plunger threads155engaged with the insert threads132, as shown inFIG.10A, pressure builds in the fluid reservoir111as the thread rail154is rotated and a proximally directed force or load acting on the flat head166pushes the proximal flank155ainto the proximal flank132a. This load may then translate to the threaded insert130and then to the fluid reservoir111through the load transfer member133and the load transfer orifice114.

FIGS.11A and11Billustrate an embodiment of the actuator170. As illustrated, the actuator170can include the handle171and a plunger guide member172. The handle171and plunger guide member172can be formed of a rigid or semi-rigid material, such as polycarbonate, polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyetheretherketone or polyoxymethylene. In some embodiments, the materials may be reinforced or filled with a filler, such as glass. Other materials are contemplated. In certain embodiments, the handle171and the plunger guide member172include a unibody construct. In other embodiments, the handle and the plunger guide member172include separate components that are configured to be assembled together. In some embodiments, the handle171may include an over molded, compliant material to improve handling of the handle171. The handle171can include a bore184. Channels185may be disposed within the bore184to engage with the ribs153of the trigger grip151to maintain axial alignment of the handle171with the trigger grip151as the handle171is displaced over the trigger grip151. Further, a proximal actuator ramp173can be disposed within the bore184to engage with the proximal plunger ramp152of the plunger150when the handle171is displaced distally relative to the trigger grip151.

The plunger guide member172can extend distally from the handle171. The plunger guide member172can include a first rail178, a second rail179, and a middle rail176that define an E-shape channel186including a first channel187and a second channel188separated by the middle rail176. In another embodiment, the plunger guide member172may include the first rail178and the second rail179that define a U-shape channel. The first channel187can receive the first rail160and the second channel188can receive the second rail161of the thread rail154. The middle rail176can be received within the channel162of the thread rail154. A distal actuator ramp174can be disposed at a distal end of each of the rails176,178,179to engage with the distal plunger ramp157when the plunger guide member172is distally displaced relative to the thread rail154. In other embodiments, one or more intermediate actuator ramps can be disposed along the length of the plunger guide member172proximal to the distal actuator ramp174. The intermediate actuator ramps can be configured to engage with one or more intermediate plunger ramps disposed along the length of the plunger150. The intermediate actuator ramps may facilitate displacement of an intermediate portion of the plunger guide member172radially inward. A resilient member177(e.g., compression spring) may be disposed around a proximal portion of the plunger guide member172. The resilient member177can be a compression coil spring to provide a return force to the handle171. Other types of resilient members are contemplated within the scope of this disclosure.

The first channel187may include support ramps189disposed along a length of the channel187with slots or gaps181disposed between adjacent support ramps189. The second channel188may include support ramps182disposed along a length of the channel188with slots or gaps183disposed between adjacent support ramps182. The support ramps189and the support ramps182may be axially offset. In other words, as shown inFIG.11B, the support ramp189is transversely aligned with the slot183. The support ramps182,189can engage with protrusions156,164of the thread rail154to maintain engagement of the plunger threads155with the insert threads132when the inflation device100is in a pressurization state. The slots181,183can receive the protrusions156,164to allow the plunger threads155to disengage with the insert threads132when the inflation device100is in a depressurization state.

In use, the inflation device100may be utilized to inflate an inflatable medical device (e.g., balloon).FIG.12Aillustrates the inflation device100in the pressurization state. As illustrated, a proximal end of a tubing102may be coupled to the nozzle113of the pressure member110and a distal end of the tubing102can be coupled to the balloon (not shown). The tubing102may be in fluid communication with the fluid reservoir111and the balloon. A fluid (e.g., saline) can be disposed within the fluid reservoir111. The plunger tip120can be disposed within the fluid reservoir111and operatively coupled to the thread rail154of the plunger150. The thread rail154may be slidingly disposed within the plunger guide member172of the actuator170such that the protrusions156of the thread rail154are engaged with the support ramps189of the plunger guide member172and protrusions164(not shown) of the thread rail154are engaged with support ramps182(not shown) of the plunger guide member172to maintain engagement of the plunger threads155with the insert threads132of the threaded insert130.

While in the pressurization state, the handle171may be rotated by a first hand of a user in a clockwise direction to displace the plunger tip120distally while grip140is grasped by a second hand of the user to prevent the fluid reservoir111from rotating. When the handle171is rotated, the thread rail154and the plunger guide member172are rotated relative to the threaded insert130causing the plunger tip120to be distally displaced by way of a threaded engagement of the plunger threads155with the insert threads132. As the plunger tip120is displaced distally, the fluid within the fluid reservoir111can be pushed into the tubing102and the balloon to inflate the balloon. Continued rotation of the handle171can cause pressure within the fluid reservoir111to increase as resistance to inflation is exerted by the balloon. The pressure within the fluid reservoir111can apply a proximally directed force or load to the plunger threads155and the insert threads132. The proximally directed force can be transferred from the insert threads132to the fluid reservoir111through the load transfer members133and load transfer orifices114. The pressure within the fluid reservoir111can be increased up to about 100 atmospheres. In certain embodiments, the reservoir pressure can be measured by a pressure gage, such as the pressure gage112.

FIG.12Billustrates the inflation device100in the depressurization state. In the depressurization state, the plunger threads155can be disengaged from the insert threads132allowing the plunger150to freely axially translate relative to the fluid reservoir111. In the illustrated embodiment, the actuator170can be displaced distally relative to the plunger150when a user applies a distally directed force to the handle171. In some embodiments, the distally directed force may be applied by a hand of the user. In another embodiment, the distally directed force can be applied when the handle171is forced against a rigid surface, such as a tabletop. The handle171may be distally displaced over the trigger grip151causing the plunger guide member172to be distally displaced relative to the thread rail154. The support ramps189may be displaced distally relative to the protrusions156, wherein the protrusions156are received in the slots181to allow the thread rail154to be displaced downward perpendicular to the longitudinal axis of the inflation device100.

The proximal actuator ramp173(not shown) can engage the proximal plunger ramp152(not shown) and the distal actuator ramp174can engage the distal plunger ramp157to displace the thread rail154radially inward such that the plunger threads155disengage from the insert threads132. The downward displacement of the thread rail154causes the proximally directed force applied to the threaded insert130and the fluid reservoir111to be released. A release force applied to the actuator170can range from about 2 pounds of force to about 12 pounds of force. Further, the distal end159of the thread rail154can be displaced downward within the plunger tip120relative to the coupling pin123. When the plunger threads155are disengaged from the insert threads132, the plunger150and the actuator170can be freely moved axially resulting in depressurization of the fluid reservoir111and the balloon.

In certain embodiments, the free axial movement of the plunger150may allow the tubing102to be quickly primed and allow air bubbles to be removed from the fluid reservoir111. Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. For example, a method of pressurizing and depressurizing an inflation device may include one or more of the following steps: radial outwardly displacing a thread rail to engage a threaded insert, wherein protrusions of a thread rail engage with support ramps of a guide member; distally displacing a plunger toward a distal end of a fluid reservoir to pressurize a fluid within the fluid reservoir; actuating an actuator to distally axially displace a guide member relative to the thread rail; radial inwardly displacing the thread rail to disengage the thread rail from the threaded insert, wherein the protrusions disengage from the support ramps and the guide member engages with a plunger ramp; and proximally displacing the plunger to depressurize the fluid within the fluid reservoir. Other steps are also contemplated.

The directional terms “distal” and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest to the practitioner during use.

“Fluid” is used in its broadest sense, to refer to any fluid, including both liquids and gases as well as solutions, compounds, suspensions, etc., that generally behaves as a fluid.

References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments the feature can have a precisely perpendicular configuration.

The terms “a” and “an” can be described as one, but not limited to one. For example, although the disclosure may recite a plunger tip having “an O-ring,” the disclosure also contemplates that the plunger tip can have two or more O-rings.

Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints.

Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention.

The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.

Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.