High-pressure inflating device

Abstract

Inflation devices and methods for inflating a balloon of a balloon catheter are disclosed. The inflation device includes a pressure member to contain a fluid to be pressurized. The pressure member includes a load transfer aperture configured to receive a load transfer member of the threaded insert. The load transfer member may transfer an axial load applied to the threaded insert during fluid pressurization to the pressure member. A plunger including a threaded rail is slidably disposed within the pressure member. The threaded rail engages the threaded insert when the fluid is pressurized. An actuator disengages the threaded rail from the threaded insert to depressurize the fluid.

Description

Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 367,572, filed on July 1, 2022, entitled “High-Pressure Inflation Device,” and U.S. Utility Application No. 18 / 344,562, filed on June 29, 2023, entitled “High-Pressure Inflation Device,” both of which are incorporated herein by reference in their entirety. Technical Field

[0002] The present disclosure generally relates to devices for pressurizing, depressurizing, or otherwise displacing fluids, particularly in medical devices. More specifically, the present disclosure relates to high pressure devices for pressurizing, depressurizing, or otherwise displacing fluids along fluid lines for inflating or deflating medical devices, such as balloons. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The embodiments disclosed herein will become more apparent from the following description and the appended claims in conjunction with the accompanying drawings. These drawings depict only typical embodiments, and these embodiments will be described in more detail and detail through the use of the accompanying drawings, in which:

[0004] Figure 1 is a perspective view of an embodiment of an inflatable device.

[0005] Figure 2 yes Figure 1 An exploded view of the inflator.

[0006] Figure 3 yes Figure 1 A side cross-sectional view of an inflatable device.

[0007] Figure 4 yes Figure 1 A perspective view of an embodiment of a pressure member of an inflatable device.

[0008] Figure 5A yes Figure 1 A stereoscopic view of an embodiment of a plunger tip of an inflation device.

[0009] Figure 5B yes Figure 5A Side cross-sectional view of the plunger tip.

[0010] Figure 6 yes Figure 1 A perspective view of an embodiment of a threaded insert for an inflator.

[0011] Figure 7 yes Figure 6The threaded insert is connected to Figure 4 A three-dimensional view of the pressure member.

[0012] Figure 8 yes Figure 1 A perspective view of an embodiment of a gripper of an inflation device.

[0013] Fig. 9A yes Figure 1 A bottom perspective view of an embodiment of a plunger of an inflation device.

[0014] Fig. 9B yes Fig. 9A A top perspective view of a plunger.

[0015] Fig. 9C yes Fig. 9B A cross-sectional view of the plunger through section line 9C-9C.

[0016] Fig. 10A yes Fig. 9A The plunger and Figure 7 Side cross-sectional view of the threaded insert in the engaged position.

[0017] Fig. 10B yes Fig. 9A The plunger and Figure 7 A side cross-sectional view of a threaded insert in a disengaged position.

[0018] Fig.11A yes Figure 1 A perspective view of an embodiment of an actuator of an inflation device.

[0019] Fig. 11B yes Fig.11A Top view of the actuator.

[0020] Fig. 12A yes Figure 1 A partial cross-sectional view of the inflatable device in a pressurized state.

[0021] Fig. 12B yes Figure 1 A partial cross-sectional view of the inflatable device in a decompressed state. DETAILED DESCRIPTION

[0022] In some cases, the inflation device is in fluid communication with a balloon disposed at the end of the catheter. The inflation device can be used to generate high pressure to inflate the balloon for various medical procedures. For example, the inflation device can be used to widen a narrowing of a blood vessel or passageway, expand a stent within a blood vessel or passageway, or block a blood vessel or passageway.

[0023] The inflatable device may include a syringe that utilizes threads to advance or retract the plunger by rotating the plunger relative to the body of the syringe, such that the threads cause the plunger to be longitudinally displaced relative to the body. In some cases, the inflatable device may further include retractable threads, enabling the physician to disengage the threads and displace the plunger by simply pushing or pulling the plunger. The inflatable device may include a threaded insert configured to constrain the movement of the plunger within the syringe body. The threaded insert may include threads configured to engage with the retractable threads.

[0024] Embodiments of an inflatable device within the scope of the present disclosure include 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 and internal threads disposed within the load transfer orifice. A plunger is slidably disposed within the pressure member and includes a threaded guide selectively coupled to the threaded insert. The threaded guide includes threads and a protrusion for engaging threads of the threaded insert. The plunger tip is operably coupled to a distal end of the plunger. The actuator includes a guide member coupled to the threaded guide. The guide member includes a ramp and a groove configured to engage a protrusion of the threaded guide.

[0025] When the inflatable device disclosed in the present disclosure is pressurized to inflate the balloon, the protrusion of the threaded guide engages the ramp of the guide member, causing the threads of the threaded guide to engage with the threads of the threaded insert. The handle of the actuator is rotated by the user, causing the plunger tip to displace distally and pressurize the fluid in the pressure member. The axial load applied to the thread is transmitted to the pressure member through the load transfer member of the threaded insert and the load transfer orifice of the pressure member. When the inflatable device is decompressed to deflate the balloon, the handle of the actuator moves distally relative to the plunger, causing the protrusion to be set in the groove of the guide member. This allows the threaded guide to shift radially inward and the threads of the threaded guide to disengage from the threads of the threaded insert. Embodiments of the disclosed inflatable device allow the inflatable device to be pressurized to a high pressure while reducing the force required to initiate decompression.

[0026] The embodiments can be understood by reference to the accompanying drawings, wherein the same components are always represented by the same numerals. It will be readily understood by those of ordinary skill in the art who benefit from the present disclosure that the components of the embodiments as generally described and shown in the drawings herein can be arranged and designed in a variety of different configurations. Therefore, as shown in the drawings, the following more detailed description of various embodiments is not intended to limit the scope of the present disclosure, but is only a representation of various embodiments. Although various aspects of the embodiments are presented in the drawings, unless specifically noted, the drawings are not necessarily drawn to scale.

[0027] Figures 1 to 3 Different views of embodiments of an inflatable device are shown. Figure 4An embodiment of a fluid reservoir for an inflation device is shown. Figure 5A and Figure 5B An embodiment of a plunger tip of an inflation device is shown. Figure 6 An embodiment of a threaded insert for an inflator is shown. Figure 7 A threaded insert coupled to a fluid reservoir is shown. Figure 8 An embodiment of a gripper for an inflatable device is shown. 9A to 9C An embodiment of a plunger of an inflation device is shown. Fig. 10A The plunger and threaded insert are shown in an engaged state. Fig. 10B The plunger and threaded insert are shown in a disengaged state. Fig.11A and Fig. 11B Embodiments of actuators for inflatable devices are presented. Fig. 12A The inflatable device is shown in a pressurized state. Fig. 12B Inflatable devices are shown in a decompressed state. In some views, each device may be coupled to or shown with additional components that are not included in every view. Further, in some views, only selected components are shown to provide detail of component relationships. Some components may be shown in multiple views but will not be discussed in conjunction with each view. The disclosure provided in conjunction with any figure is relevant and applicable to the disclosure provided in conjunction with any other figure or embodiment.

[0028] Figure 1 An embodiment of an inflatable device 100 is shown. Figure 1 As shown, the inflatable device 100 may include three major component groups; each group may have many sub-components and parts. The three major component groups are: pressure member 110, plunger 150 and actuator 170.

[0029] Figure 2 and Figure 3 An embodiment of an inflation device 100 is shown. As shown, the pressure member 110 may include a fluid reservoir 111, a plunger tip 120 slidably disposed within the fluid reservoir 111, a threaded insert 130 coupled to the fluid reservoir 111, and a gripper 140 coupled to the exterior of the fluid reservoir 111. Further, as shown Figure 2 As shown, the plunger 150 may include a trigger gripper 151 and a threaded guide 154 extending distally from the trigger gripper 151. Figure 2 As shown, the actuator 170 may include a handle 171 , a plunger guide member 172 extending distally from the handle 171 , and a compliant member 177 disposed around the plunger guide member 172 .

[0030] Figure 4An embodiment of a fluid reservoir 111 of a pressure member 110 is shown. As shown in this embodiment, the fluid reservoir 111 may include a cylindrical shape defining a pressure chamber 119. The pressure chamber 119 may have a diameter ranging from about 15.2 mm to about 30.5 mm, and may be about 16.3 mm. The fluid reservoir 111 may be formed of a rigid material capable of withstanding high pressure without breaking or deforming. For example, the fluid reservoir 111 may be formed of polycarbonate, glass, metal, copolyester, nylon, cycloolefin polymer or cycloolefin copolymer. Other materials may be contemplated. A mouth 113 may be disposed at a distal end and may be in fluid communication with the pressure chamber 119. In some embodiments, the mouth 113 is a male Luer connector. The mouth 113 may be configured to couple an inflatable medical device to the fluid reservoir 111. Fluid from the pressure chamber 119 may flow through the mouth 113 and enter the inflatable medical device, thereby inflating the inflatable medical device. Fluid may also flow from the inflatable medical device through the mouthpiece 113 and into the pressure chamber 119, thereby allowing the inflatable medical device to deflate. In certain embodiments, the inflatable medical device is a balloon.

[0031] A pair of longitudinal flexure members 115 may be disposed at the proximal end of the fluid reservoir 111. A groove 116 may be disposed between the flexure members 115 to allow the flexure members 115 to deflect radially inwardly and outwardly. A load transfer aperture 114 may be disposed in each flexure member 115. The load transfer aperture 114 may be sized and shaped to receive a load transfer member of a threaded insert 130, as will be described below. When the threaded insert 130 is coupled to the fluid reservoir 111, the flexure members 115 may flex radially outwardly on the threaded insert 130. One or more longitudinal ribs 117 may be disposed adjacent to the flexure members 115. The ribs 117 may prevent the gripper 140 from rotating relative to the fluid reservoir 111.

[0032] Optionally or alternatively, the pressure gauge 112 can be coupled to the fluid reservoir 111 such that the pressure gauge 112 is in fluid communication with the pressure chamber 119. The pressure gauge 112 can be of any suitable type for measuring the pressure of the fluid within the fluid reservoir 111. For example, the pressure gauge 112 can be an analog pressure gauge or a digital pressure gauge. Other types of pressure gauges are contemplated.

[0033] Figure 5A and Figure 5B An embodiment of a plunger tip 120 is shown. Figure 5A and Figure 5BAs shown, the plunger tip 120 may include a body 121 having a cylindrical shape. The plunger tip 120 may be formed of any suitable material, such as polycarbonate, high-density polyethylene, polypropylene, acrylonitrile butadiene styrene, nylon, polyoxymethylene, polysulfone, polyetheretherketone, etc. In some embodiments, these materials may be reinforced or filled with fillers (such as glass). The circumferential channel 122 may be disposed adjacent to the distal end 126. An O-ring 129 may be disposed in the channel 122 to create a seal between the body 121 and the inner surface of the fluid reservoir 111. The distal end 126 may be concave to reduce bubbles in the fluid reservoir 111, thereby allowing bubbles to be more easily removed from the fluid reservoir during the infusion of the inflatable device 100. For example, the transition angle from the distal end 126 to the inner surface of the fluid reservoir 111 may be greater than 90 degrees to substantially prevent bubbles from being trapped between the distal end 126 and the inner surface of the fluid reservoir 111. The hole 127 can be open at the proximal end 128 and closed at the distal end 126. The engagement member 125 can be disposed within the hole 127 to engage the distal end of the threaded guide 154. The engagement member 125 can include a proximal surface oriented perpendicular to the longitudinal axis of the body 121. The coupling pin 123 can be disposed through the pin hole 124 disposed adjacent the proximal end 128 to operatively couple the threaded guide 154 to the plunger tip 120. The coupling pin 123 can be a spring pin or any other suitable type of pin.

[0034] Figure 6 An embodiment of a threaded insert 130 is shown. As shown, the threaded insert 130 may include a cylindrical body 131 having a hole 136 therethrough. The threaded insert 130 may be formed of a rigid or semi-rigid polymer material. For example, the material may be polycarbonate, high-density polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyetheretherketone, or polyoxymethylene. In some embodiments, these materials may be reinforced or filled with fillers such as glass. Other materials are contemplated. The hole 136 may include an internal spiral insert thread 132 extending along the length of the hole 136. The insert thread 132 may include a single start or a double start. A load transfer member 133 may be disposed on opposite sides of the outer surface of the body 131. The load transfer member 133 may have an arcuate shape to transfer axial loads from the threaded insert 130 to the pressure member 110. In other embodiments, the load transfer member 133 may include any other suitable shape. Further, a groove feature 134 may be provided on the outer surface of the body 131 between the load transfer members 133 .

[0035] Figure 7A threaded insert 130 is shown coupled to a fluid reservoir 111. As shown, the threaded insert 130 can be disposed within the fluid reservoir 111 with a load transfer member 133 disposed within the load transfer aperture 114. A groove feature 134 can be disposed within the groove 116 to guide the threaded insert 130 into the fluid reservoir 111. The load transfer member 133 can include a ramp 138 to assist in disposing the load transfer member 133 within the load transfer aperture 114. When the threaded insert 130 is inserted into the fluid reservoir 111, the ramp 138 can deflect the flexure member 115 radially outward.

[0036] Figure 8 An embodiment of a gripper 140 is shown. As shown, the gripper 140 can include a body 141 having a hole 142 extending therethrough. The body 141 can be formed of a rigid or semi-rigid material, such as polycarbonate, polyethylene, polypropylene, polyurethane, acrylonitrile butadiene styrene, nylon, polyoxymethylene, or a thermoplastic elastomer. Other materials are contemplated. A longitudinal channel 143 can be disposed within the hole 142 to receive a rib 117 of the fluid reservoir 111. When the rib 117 is disposed within the channel 143, the gripper 140 is prevented from rotating relative to the fluid reservoir 111. The gripper 140 can have an ergonomic shape or surface to allow a user to grasp the gripper 140 with a hand to prevent the fluid reservoir 111 from rotating when the actuator 170 is rotated. For example, in the illustrated embodiment, the gripper 140 includes a protrusion 144 to provide an ergonomic gripping shape. In other embodiments, the outer surface of the gripper 140 may include bumps, recesses, ribs, knurling, textures, or compliant materials.Other ergonomic shapes and surfaces are contemplated within the scope of the present disclosure.

[0037] 9A to 9C An embodiment of a plunger 150 is shown. As shown, the plunger 150 may include a trigger gripper 151 and a threaded guide 154. The plunger 150 may 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, these materials may be reinforced or filled with fillers (such as glass). Other materials are contemplated. The trigger gripper 151 may include a grippable shape, including a finger gripper, to be gripped by the user's fingers. A proximal plunger ramp 152 may be disposed adjacent to the proximal end of the trigger gripper 151 to dock with the proximal actuator ramp of the actuator 170, as will be discussed below. A longitudinal rib 153 may be disposed on the outer surface of the trigger gripper 151 to maintain the axial alignment of the trigger gripper 151 with the handle 171 when the handle 171 is displaced on the trigger gripper 151.

[0038] The threaded guide 154 can extend distally from the trigger gripper 151. As shown, the threaded guide 154 can include a first guide 160 and a second guide 161 extending parallel to each other. A channel 162 is disposed between the guides 160, 161. Each of the guides 160, 161 can include a protrusion 156, 164 extending downwardly from the guides 160, 161, respectively. The protrusions 156 of the first guide 160 can be separated by a gap 163, and the protrusions 164 of the second guide 161 can be longitudinally separated by a gap 165. Further, the protrusions 156 of the first guide 160 can be longitudinally offset relative to the protrusions 164 of the second guide 161. In other words, as Fig. 9C As shown, a transverse cross-section of the threaded rail 154 through section 9C-9C shows that the protrusion 156 of the first rail 160 is laterally aligned with the gap 165 of the second rail 161.

[0039] The distal plunger ramp 157 can be disposed adjacent to the distal end 159 of the threaded guide 154 to engage with the distal actuator ramp of the actuator 170, as will be discussed below. A pin passage 158 can be disposed adjacent to the distal end 159 through the threaded guide 154 to receive the coupling pin 123 of the plunger tip 120. The distal end 159 can include a flat head 166 for pressing against the engagement member 125 of the plunger tip 120 when the plunger 150 is displaced distally to pressurize the fluid reservoir 111. Further, the flat head 166 can slidably engage with the engagement member 125 when the threaded guide 154 is disengaged from the threaded insert 130.

[0040] The threaded guide 154 may include outer plunger threads 155 disposed along the length of the threaded guide 154 to selectively engage with the insert threads 132 of the threaded insert 130. The plunger threads 155 may include an arc length from about 45 degrees to about 60 degrees, and may be about 52 degrees.

[0041] Fig. 10A and Fig. 10B Two operable positions of the threaded guide 154 relative to the threaded insert 130 are shown. Fig. 10A The thread guide 154 is shown disposed in an engaged position such that the plunger threads 155 engage the insert threads 132 . Fig. 10B The threaded guide 154 is shown in a disengaged position, wherein the threaded guide 154 is fully retracted into the threaded insert 130 such that the plunger threads 155 are not engaged with the insert threads 132 .

[0042] Each insert thread 132 includes a proximal side 132a and a distal side 132b. Each plunger thread 155 includes a proximal side 155a and a distal side 155b. The proximal sides 132a, 155a are configured to engage when the plunger 150 is screwed into the threaded insert 130. In the illustrated embodiment, the proximal side 155a of the plunger thread 155 and the proximal side 132a of the insert thread 132 include an engagement angle β, which can be in a range from about 45 degrees to about 90 degrees and from about 70 degrees to about 80 degrees. The pitch of the threads 132, 155 can be in a range from about 8 threads per inch to about 16 threads per inch. The height of the threads 132, 155 can be in a range from about 0.040 inches to about 0.100 inches. When the plunger thread 155 engages with the insert thread 132, as Fig. 10A As shown, when the threaded guide 154 is rotated, pressure is built up in the fluid reservoir 111, and the proximally directed force or load acting on the flat head 166 pushes the proximal side 155a into the proximal side 132a. This load can then be transferred to the threaded insert 130 and then to the fluid reservoir 111 through the load transfer member 133 and the load transfer aperture 114.

[0043] Fig.11A and Fig. 11B An embodiment of an actuator 170 is shown. As shown, the actuator 170 may include a handle 171 and a plunger guide member 172. The handle 171 and the plunger guide member 172 may 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, these materials may be reinforced or filled with fillers (such as glass). Other materials are contemplated. In certain embodiments, the handle 171 and the plunger guide member 172 include a monolithic construction. In other embodiments, the handle and the plunger guide member 172 include separate components configured to be assembled together. In some embodiments, the handle 171 may include an overmolded compliant material to improve manipulation of the handle 171. The handle 171 may include a hole 184. The channel 185 can be disposed within the hole 184 to engage with the rib 153 of the trigger gripper 151 to maintain the axial alignment of the handle 171 with the trigger gripper 151 when the handle 171 is displaced on the trigger gripper 151. Further, the proximal actuator ramp 173 can be disposed within the hole 184 to engage with the proximal plunger ramp 152 of the plunger 150 when the handle 171 is displaced distally relative to the trigger gripper 151.

[0044] The plunger guide member 172 may extend distally from the handle 171. The plunger guide member 172 may include a first rail 178, a second rail 179, and an intermediate rail 176 that define an E-shaped channel 186 including a first channel 187 and a second channel 188 separated by the intermediate rail 176. In another embodiment, the plunger guide member 172 may include a first rail 178 and a second rail 179 that define a U-shaped channel. The first channel 187 may receive the first rail 160, and the second channel 188 may receive the second rail 161 of the threaded guide 154. The intermediate rail 176 may be received within the channel 162 of the threaded guide 154. The distal actuator ramp 174 may be provided at the distal end of each of the rails 176, 178, 179 so as to engage with the distal plunger ramp 157 when the plunger guide member 172 is displaced distally relative to the threaded guide 154. In other embodiments, one or more intermediate actuator ramps may be disposed proximally of the distal actuator ramp 174 along the length of the plunger guide member 172. The intermediate actuator ramps may be configured to engage with one or more intermediate plunger ramps disposed along the length of the plunger 150. The intermediate actuator ramps may facilitate radial inward displacement of the intermediate portion of the plunger guide member 172. A resilient member 177 (e.g., a compression spring) may be disposed around the proximal portion of the plunger guide member 172. The resilient member 177 may be a compression coil spring to provide a return force to the handle 171. Other types of resilient members are contemplated within the scope of the present disclosure.

[0045] The first channel 187 may include support ramps 189 disposed along the length of the channel 187, wherein slots or gaps 181 are disposed between adjacent support ramps 189. The second channel 188 may include support ramps 182 disposed along the length of the channel 188, wherein slots or gaps 183 are disposed between adjacent support ramps 182. The support ramps 189 and the support ramps 182 may be axially offset. In other words, as Fig. 11B As shown, the support ramp 189 is laterally aligned with the groove 183. The support ramps 182, 189 can engage with the projections 156, 164 of the threaded guide 154 to maintain the engagement of the plunger threads 155 with the insert threads 132 when the inflator 100 is in a pressurized state. The grooves 181, 183 can receive the projections 156, 164 to allow the plunger threads 155 to disengage from the insert threads 132 when the inflator 100 is in a depressurized state.

[0046] In use, the inflation device 100 may be used to inflate an inflatable medical device (eg, a balloon). Fig. 12AThe inflatable device 100 is shown in a pressurized state. As shown, the proximal end of the tube 102 can be coupled to the mouth 113 of the pressure member 110, and the distal end of the tube 102 can be coupled to the balloon (not shown). The tube 102 can be in fluid communication with the fluid reservoir 111 and the balloon. A fluid (e.g., saline) can be disposed in the fluid reservoir 111. The plunger tip 120 can be disposed in the fluid reservoir 111 and operatively coupled to the threaded guide 154 of the plunger 150. The threaded guide 154 can be slidably disposed in the plunger guide member 172 of the actuator 170, so that the protrusion 156 of the threaded guide 154 engages with the support ramp 189 of the plunger guide member 172, and the protrusion 164 (not shown) of the threaded guide 154 engages with the support ramp 182 (not shown) of the plunger guide member 172 to retain the plunger threads 155 in engagement with the insert threads 132 of the threaded insert 130.

[0047] When in the pressurized state, the handle 171 can be rotated in a clockwise direction by the user's first hand to displace the plunger tip 120 distally, while the gripper 140 is grasped by the user's second hand to prevent the fluid reservoir 111 from rotating. When the handle 171 is rotated, the threaded guide 154 and the plunger guide member 172 rotate relative to the threaded insert 130, thereby causing the plunger tip 120 to displace distally through the threaded engagement of the plunger thread 155 with the insert thread 132. When the plunger tip 120 is displaced distally, the fluid in the fluid reservoir 111 can be pushed into the tube 102 and the balloon to inflate the balloon. Continued rotation of the handle 171 can cause the pressure in the fluid reservoir 111 to increase as the balloon applies inflation resistance. The pressure in the fluid reservoir 111 can apply a force or load directed proximally to the plunger thread 155 and the insert thread 132. The proximally directed force can be transferred from the insert threads 132 to the fluid reservoir 111 through the load transfer member 133 and the load transfer aperture 114. The pressure within the fluid reservoir 111 can rise to about 100 atmospheres. In some embodiments, the reservoir pressure can be measured by a pressure gauge, such as pressure gauge 112.

[0048] Fig. 12BThe inflatable device 100 is shown in a decompressed state. In the decompressed state, the plunger threads 155 can be disengaged from the insert threads 132, thereby allowing the plunger 150 to freely translate axially relative to the fluid reservoir 111. In the illustrated embodiment, the actuator 170 can be displaced distally relative to the plunger 150 when a user applies a distally directed force to the handle 171. In some embodiments, the distally directed force can be applied by the user's hand. In another embodiment, the distally directed force can be applied when the handle 171 is pressed against a rigid surface (such as a tabletop). The handle 171 can be displaced distally on the trigger gripper 151, thereby causing the plunger guide member 172 to be displaced distally relative to the threaded guide 154. The support ramp 189 can be displaced distally relative to the protrusion 156, wherein the protrusion 156 is received in the groove 181 to allow the threaded guide 154 to be displaced downwardly perpendicular to the longitudinal axis of the inflatable device 100.

[0049] The proximal actuator ramp 173 (not shown) can engage the proximal plunger ramp 152 (not shown), and the distal actuator ramp 174 can engage the distal plunger ramp 157 to displace the threaded guide 154 radially inwardly so that the plunger threads 155 are disengaged from the insert threads 132. The downward displacement of the threaded guide 154 causes the proximally directed force applied to the threaded insert 130 and the fluid reservoir 111 to be released. The release force applied to the actuator 170 can be in the range of from about 2 pounds force to about 12 pounds force. Further, the distal end 159 of the threaded guide 154 can be displaced downwardly within the plunger tip 120 relative to the coupling pin 123. When the plunger threads 155 are disengaged from the insert threads 132, the plunger 150 and the actuator 170 can be free to move axially, thereby decompressing the fluid reservoir 111 and the balloon.

[0050] In some embodiments, the free axial movement of the plunger 150 can allow the tube 102 to be quickly primed and allow bubbles to be removed from the fluid reservoir 111. Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchangeable with each other. In other words, unless a specific sequence of steps or actions is required for the correct operation of the embodiment, the order and / or use of specific steps and / or actions can be modified. For example, a method for pressurizing and decompressing an inflatable device may include one or more of the following steps: radially displacing a threaded guide radially outward to engage a threaded insert, wherein a protrusion of the threaded guide engages a support ramp of a guide member; displacing the plunger distally toward the distal end of the fluid reservoir to pressurize the fluid in the fluid reservoir; actuating an actuator to displace the guide member axially distally relative to the threaded guide; displacing the threaded guide radially inward to disengage the threaded guide from the threaded insert, wherein the protrusion disengages from the support ramp and the guide member engages with the plunger ramp; and displacing the plunger proximally to decompress the fluid in the fluid reservoir. Other steps are also contemplated.

[0051] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Therefore, as described throughout this specification, referenced phrases or variations thereof are not necessarily all referring to the same embodiment.

[0052] Similarly, in the above description of the embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of simplifying the disclosure. However, this method of disclosure is not to be interpreted as reflecting an intention that any claim requires more features than those explicitly recited in the claim. Rather, as reflected in the following claims, inventive aspects lie in a combination of fewer features than all of the features of any single previously disclosed embodiment.

[0053] The phrase "coupled to" refers to any form of interaction between two or more entities, including mechanical interaction, electrical interaction, magnetic interaction, electromagnetic interaction, fluid interaction, and thermal interaction. Two components can be coupled to each other even if they are not in direct contact with each other. For example, two components can be coupled to each other through an intermediate component.

[0054] The directional terms "distal" and "proximal" have their ordinary meanings in the art. That is, the distal end of a medical device refers to the end of the device farthest from a physician during use. The proximal end refers to the opposite end, or the end closest to a physician during use.

[0055] "Fluid" is used in its broadest sense to refer to any fluid, including liquids and gases, as well as solutions, complexes, suspensions, etc. that generally behave as fluids.

[0056] Reference is made throughout this specification to approximation, such as by use of the term "substantially." For each such reference, it is understood that in some embodiments, a value, feature, or characteristic may be specified without approximation. For example, where modifiers such as "about" and "substantially" are used, these terms include within their scope the modified term without their modifiers. For example, where the term "substantially perpendicular" is referenced with respect to a feature, it is understood that in other embodiments, the feature may have a precisely perpendicular configuration.

[0057] The terms "a" and "an" may describe one, but are not limited to one. For example, although the disclosure may refer to a plunger tip having an "O-ring", the disclosure also contemplates that the plunger tip may have two or more O-rings.

[0058] Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints.

[0059] The recitation of the term "first" in a claim regarding a feature or element does not necessarily imply the presence of a second or additional such feature or element. It will be apparent to those skilled in the art that changes may be made to the details of the above-described embodiments without departing from the basic principles of the invention.

[0060] The claims following this written disclosure are expressly incorporated into this written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of independent claims and their dependent claims. Furthermore, additional embodiments that can be derived from the following independent and dependent claims are also expressly incorporated into this written description.

[0061] Without further elaboration, it is believed that those skilled in the art can use the foregoing description to make the most of the present invention. The claims and embodiments disclosed herein should be understood to be illustrative and exemplary only, and not to limit the scope of the present disclosure in any way. It will be apparent to those skilled in the art that, with the aid of the present disclosure, changes can be made to the details of the above-described embodiments without departing from the basic principles of the present disclosure. In other words, various modifications and improvements of the embodiments specifically disclosed in the above description are within the scope of the appended claims. In addition, without departing from the scope of the present disclosure, those skilled in the art can change the order of steps or actions of the methods disclosed herein. In other words, unless a specific step or action sequence is required for the correct operation of the embodiment, the order or use of specific steps or actions can be modified. Therefore, the scope of the present invention is defined by the following claims and their equivalents.

Claims

1. An inflatable device, comprising: Pressure components, including: a fluid reservoir, wherein the fluid reservoir comprises a load transfer orifice; Threaded inserts, including: a load transferring member configured to be disposed within the load transferring aperture; and Internal thread; Plunger, comprising: Trigger gripper; a threaded guide extending distally from the trigger gripper and comprising: external threads configured to engage with the internal threads of the threaded insert; and protrusions extending downwardly from the threaded rail; and a plunger tip coupled to a distal end of the threaded guide; and Actuator, comprising: a handle operably coupled to the trigger grip; and a guide member extending distally from the handle and comprising: support ramps configured to engage with projections of the threaded rail; and Slots are disposed between the ramps and are configured to receive the projections.

2. The inflatable device according to claim 1, wherein: The load transfer member and the load transfer aperture are configured to transfer axial loads from the internal threads of the threaded insert to the fluid reservoir.

3. An inflator as claimed in any one of claims 1 and 2, wherein: The pressure member further includes a pressure gauge in fluid communication with the fluid reservoir to measure a fluid pressure within the fluid reservoir.

4. The inflator according to any one of claims 1 to 3, wherein: The fluid reservoir further includes a mouthpiece to allow fluid pressure to be transferred from the fluid reservoir to the inflatable medical device.

5. The inflator according to any one of claims 1 to 4, wherein: The plunger tip includes: The main body includes: Circumferential grooves; Pin hole; an interface member for coupling with the distal end of the threaded guide rail; and distal surface; an O-ring disposed within the circumferential groove; and A pin is disposed through the pin hole to couple the threaded guide to the plunger tip.

6. The inflatable device according to claim 5, wherein: The distal face is concave.

7. An inflator as claimed in any one of claims 5 and 6, wherein: The transition angle from the distal face to the inner surface of the fluid reservoir is greater than 90 degrees.

8. An inflator according to any one of claims 1 to 7, wherein: The internal threads of the threaded insert and the external threads of the threaded rail include an engagement angle ranging from 45 degrees to 90 degrees.

9. An inflator according to any one of claims 1 to 8, wherein: The plunger further comprises: a distal plunger ramp disposed adjacent a distal end of the threaded rail; a proximal plunger ramp disposed adjacent the trigger gripper; and The U-shaped channel of the threaded guide rail is used to receive the guide member.

10. An inflator as claimed in any one of claims 1 to 9, in, The projections are arranged in first and second rows along the length of the threaded rail; wherein each of the protrusions in the first column is longitudinally offset from an adjacent protrusion in the first column, wherein a gap is provided between adjacent protrusions in the first column; wherein each of the protrusions in the second column is longitudinally offset from an adjacent protrusion in the second column, wherein a gap is provided between adjacent protrusions in the second column; and Wherein each of the protrusions in the first column is longitudinally offset from an adjacent protrusion in the second column.

11. An inflator according to any one of claims 1 to 10, wherein: The actuator further comprises: a channel of the guide member for slidingly receiving the threaded rail; a distal actuator ramp disposed adjacent the distal end of the guide member to engage the distal plunger ramp; a proximal actuator ramp disposed adjacent the handle to engage the proximal plunger ramp; and Support ramps are provided within the guide member.

12. The inflatable device according to claim 11, in, The support ramps are arranged in first and second rows along the length of the guide member, wherein each of the support ramps in the first column is longitudinally offset from an adjacent ramp in the first column, wherein a slot is provided between adjacent support ramps in the first column, wherein each of the support ramps in the second column is longitudinally offset from an adjacent ramp in the second column, wherein a slot is disposed between adjacent support ramps in the second column, and Wherein, each of the support ramps in the first column is longitudinally offset from an adjacent support ramp in the second column.

13. An inflatable device comprising: a threaded insert including a load transferring member; a plunger including an elongated threaded rail for selectively engaging the threaded insert, and An actuator includes a guide member operatively coupled to the threaded guide rail.

14. The inflatable device according to claim 13, in, The threaded rail includes a plurality of protrusions extending from a bottom surface of the threaded rail; wherein the plurality of protrusions are arranged in a first row and a second row along the length of the threaded guide rail; wherein each protrusion of the plurality of protrusions in the first column is longitudinally offset from an adjacent protrusion in the first column, wherein a gap is provided between adjacent protrusions; wherein each of the plurality of protrusions in the second column is longitudinally offset from an adjacent protrusion in the second column, wherein a gap is provided between adjacent protrusions; and Wherein, each of the plurality of protrusions in the first column is longitudinally offset from an adjacent protrusion in the second column.

15. An inflatable device as claimed in any one of claims 13 and 14, in, The guide member includes a plurality of support ramps disposed within the guide channel; wherein the plurality of support slopes are arranged in a first row and a second row along the length of the guide member; wherein each support ramp of the plurality of support ramps in the first column is longitudinally offset from an adjacent support ramp in the first column, wherein a slot is disposed between adjacent support ramps; wherein each of the plurality of support ramps in the second column is longitudinally offset from an adjacent support ramp in the first column, wherein a slot is disposed between adjacent support ramps; and Each of the plurality of support ramps in the first column is longitudinally offset from an adjacent support ramp in the second column.

16. An inflatable device as claimed in any one of claims 14 and 15, in, When the inflatable device is in a pressurized state, the plurality of protrusions engage the plurality of support ramps to engage the threaded rail with the threaded insert.

17. An inflator as claimed in any one of claims 13 to 16, wherein: When the inflatable device is in the pressurized state, the load transferring member transfers the axial load from the threaded insert to the fluid reservoir.

18. An inflatable device as claimed in any one of claims 14 and 15, wherein: The plurality of projections are disposed within the grooves to disengage the threaded guide from the threaded insert when the inflatable device is in a depressurized state.

19. A method of pressurizing and depressurizing an inflatable device, comprising: displacing the threaded rail radially outward to engage the threaded insert, wherein a projection of the threaded rail engages a support ramp of the guide member; displacing the plunger distally toward a distal end of the fluid reservoir to pressurize fluid within the fluid reservoir; actuating an actuator to axially displace the guide member distally relative to the threaded track; displacing the thread track radially inwardly to disengage the thread track from the threaded insert, wherein the projections disengage the support ramps and the guide member engages the plunger ramp; and The plunger is displaced proximally to depressurize the fluid within the fluid reservoir.

20. The method of claim 19, further comprising transferring the proximally directed load applied to the threaded insert to the fluid reservoir, wherein The proximally directed load is transferred through the load transferring member of the threaded insert and the load transferring aperture of the fluid reservoir.

21. The method of claim 19, further comprising coupling a threaded insert to the fluid reservoir, wherein: The load transferring member of the threaded insert snap fits with the load transferring aperture of the fluid reservoir.

22. The method of claim 19, further comprising coupling the threaded guide to the plunger tip, wherein: The threaded guide is vertically displaceable relative to the longitudinal axis of the plunger tip.

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