High-pressure expansion device

Abstract

An inflation device and method for inflating a balloon of a balloon catheter are disclosed. The inflation device includes a pressurizing member containing a pressurized fluid. The pressurizing 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 pressurizing member. A plunger including a thread rail is slidably disposed within the pressurizing member. The thread rail engages the threaded insert when the fluid is pressurized. An actuator disengages the thread rail from the threaded insert to depressurize the fluid.

Description

Technical Field

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 367,572, filed on July 1, 2022, and entitled "High-Pressure Inflation Device", and U.S. Utility Patent Application No. 18 / 344,562, filed on June 29, 2023, and entitled "High-Pressure Inflation Device", both of which are incorporated herein by reference in their entirety.

[0002] The present disclosure generally relates to devices used to pressurize, depressurize, or otherwise displace fluids, particularly in medical devices. More particularly, the present disclosure relates to high-pressure devices used to pressurize, depressurize, or otherwise displace fluids along a fluid line to inflate or deflate medical devices such as balloons.

Summary of the Invention

Means for Solving the Problems

[0003] The embodiments disclosed herein will become more fully apparent from the following description and the appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, and those embodiments will be described with additional specificity and detail using the accompanying drawings.

Brief Description of the Drawings

[0004]

Figure 1

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Figure 5A

Figure 5B

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Figure 9A

Figure 9B

Figure 9C

Figure 10A

Figure 10B

Figure 11A

Figure 11B

Figure 12A

Figure 12B

DETAILED DESCRIPTION OF THE INVENTION

[0005] In a particular example, the inflation device is in fluid communication with a balloon disposed at the end of a catheter. The inflation device may be used to generate a high pressure to inflate the balloon for various medical procedures. For example, the inflation device can be used to widen a stenosis in a blood vessel or passageway, expand a stent within a blood vessel or passageway, or occlude a blood vessel or passageway.

[0006] The inflation device may include a syringe that utilizes a thread to advance or retract a plunger by rotating the plunger relative to the syringe body such that the thread causes a longitudinal displacement of the plunger relative to the body. In some cases, the inflation device may further include a retractable thread that enables an operator to disengage the thread and displace the plunger by simply pushing or pulling the plunger. The inflation device may include a threading insert configured to restrict movement of the plunger within the syringe body. The threading insert may include a thread configured to engage the retractable thread.

[0007] Embodiments of the inflation device within the scope of the present disclosure include a pressurizing member having a load transfer orifice. The threading insert is connected to the pressurizing member. The threading insert includes a load transfer member disposed within the load transfer orifice and an internal thread. The plunger includes a threaded rail slidably disposed within the pressurizing member and selectively connected to the threading insert. The threaded rail includes a thread that engages the thread of the threading insert and a protrusion. The plunger tip is operably connected to the distal end of the plunger. The actuator includes a guide member connected to the threaded rail. The guide member includes an inclined portion and a slot configured to engage the protrusion of the threaded rail.

[0008] When the inflation device disclosed within the scope of the present disclosure is pressurized to inflate the balloon, the protrusion of the thread rail engages with the inclined portion of the guide member, and the thread of the thread rail is engaged with the thread of the threading insert. The handle of the actuator is rotated by the user to move the plunger tip distally to pressurize the fluid within the pressurizing member. The axial load applied to the thread is transmitted to the pressurizing member via the load transmission member of the threading insert and the load transmission orifice of the pressurizing member. When the inflation device is depressurized to deflate the balloon, the handle of the actuator is moved distally relative to the plunger, and the protrusion is disposed in the slot of the guide member. Thereby, it becomes possible to move the thread rail radially inward and disengage the thread of the thread rail from the thread of the threading insert. The disclosed embodiments of the inflation device enable the inflation device to be pressurized to a high pressure while reducing the force required for activation of depressurization.

[0009] Embodiments may be understood with reference to the drawings, and like parts are designated by like numerals throughout. It will be readily understood by those skilled in the art who benefit from the present disclosure that the components of the present embodiments can be arranged and designed in a wide variety of different configurations as generally described and illustrated in the drawings of this specification. Thus, the following more detailed description of the various embodiments is not intended to limit the scope of the present disclosure and is merely representative of the various embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0010] Figures 1-3 show different views of an embodiment of the inflation device. Figure 4 shows an embodiment of the fluid reservoir of the inflation device. Figures 5A and 5B show embodiments of the plunger tip of the inflation device. Figure 6 shows an embodiment of the threaded insert of the inflation device. Figure 7 shows a threaded insert coupled to the fluid reservoir. Figure 8 shows an embodiment of the grip of the inflation device. Figures 9A-9C show embodiments of the plunger of the inflation device. Figure 10A shows the plunger and threaded insert in an engaged state. Figure 10B shows the plunger and threaded insert in a disengaged state. Figures 11A and 11B show embodiments of the actuator of the inflation device. Figure 12A shows the inflation device in a pressurized state. Figure 12B shows the inflation device in a depressurized state. In certain figures, each device may be connected to additional components not included in all figures, or may be shown with additional components. Further, in some figures, only selected components are shown to provide details of the relationships of the components. Some components may be shown in multiple figures but are not discussed in relation to all figures. The disclosure provided in relation to any figure is related to and applicable to the disclosure provided in relation to any other figure or embodiment.

[0011] Figure 1 shows an embodiment of an inflation device 100. As shown in Figure 1, the inflation device 100 can include three broad groups of components. Each group may have many sub-components and parts. The three broad groups of components are a pressurizing member 110, a plunger 150, and an actuator 170.

[0012] Figures 2 and 3 illustrate an embodiment of the inflation device 100. As shown, the pressurizing 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 grip 140 coupled to the outside of the fluid reservoir 111. Further, as shown in FIG. 2, the plunger 150 may include a trigger grip 151 and a threaded rail 154 extending distally from the trigger grip 151. Further, as shown in FIG. 2, 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 about the plunger guide member 172.

[0013] FIG. 4 illustrates an embodiment of the fluid reservoir 111 of the pressurizing member 110. As shown in the embodiment, the fluid reservoir 111 may include a cylindrical shape defining a pressure chamber 119. The pressure chamber 119 may have a diameter of from about 15.2 millimeters to about 30.5 millimeters and may be about 16.3 millimeters. The fluid reservoir 111 may be formed from a rigid material capable of withstanding high pressures without breaking or deforming. For example, the fluid reservoir 111 may be formed from polycarbonate, glass, metal, copolyester, nylon, cyclic olefin polymer, or cyclic olefin copolymer. Other materials are contemplated. The nozzle 113 may be disposed at the distal end and may be in fluid communication with the pressure chamber 119. In some embodiments, the nozzle 113 is a male luer fitting. The nozzle 113 may be configured to couple an inflatable medical device to the fluid reservoir 111. Fluid from the pressure chamber 119 can flow through the nozzle 113 to the inflatable medical device to inflate the inflatable medical device. Fluid can also flow from the inflatable medical device, through the nozzle 113, to the pressure chamber 119 to deflate the inflatable medical device. In one embodiment, the inflatable medical device is a balloon.

[0014] A pair of longitudinal flexure members 115 may be disposed at the proximal end of the fluid reservoir 111. The slot 116 can be disposed between the flexure members 115 and can deflect the flexure members 115 radially inwards and outwards. The load transfer orifice 114 can be disposed in each of the flexure members 115. The load transfer orifice 114 may be dimensioned and shaped to receive the load transfer member of the threaded insert 130 as described below. The flexure member 115 can bend radially outwards on the threaded insert 130 when the threaded insert 130 is connected to the fluid reservoir 111. One or more longitudinal ribs 117 may be disposed adjacent to the flexure member 115. The rib 117 can prevent rotation of the grip 140 relative to the fluid reservoir 111.

[0015] Optionally or alternatively, the pressure gauge 112 can be connected to the fluid reservoir 111 such that the pressure gauge 112 is in fluid communication with the pressure chamber 119. The pressure gauge 112 may be any suitable type of pressure gauge for measuring the fluid pressure 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 conceivable.

[0016] Figures 5A and 5B show an embodiment of the plunger tip 120. As shown in FIGS. 5A and 5B, the plunger tip 120 can include a body 121 having a cylindrical shape. The plunger tip 120 may be formed from any suitable material such as polycarbonate, high density polyethylene, polypropylene, acrylonitrile butadiene styrene, nylon, polyoxymethylene, polysulfone, polyether ether ketone. In some embodiments, the material may be reinforced or filled with a filler such as glass. The circumferential channel 122 can be disposed adjacent to the distal end 126. The O-ring 129 may be disposed within 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 air bubbles within the fluid reservoir 111 to allow for easier removal of air bubbles from the fluid reservoir during priming of the inflation device 100. For example, the transition angle from the distal end 126 to the inner surface of the fluid reservoir 111 can be greater than 90 degrees to substantially prevent air bubbles from being trapped between the distal end 126 and the inner surface of the fluid reservoir 111. The bore 127 can open at the proximal end 128 and close at the distal end 126. The engagement member 125 may be disposed within the bore 127 to engage the distal end of the threaded rail 154. The engagement member 125 can include a proximal face oriented perpendicular to the longitudinal axis of the body 121. The coupling pin 123 may be disposed through a pin hole 124 disposed adjacent to the proximal end 128 to operably couple the threaded rail 154 to the plunger tip 120. The coupling pin 123 can be a spring pin or any other suitable type of pin.

[0017] FIG. 6 shows an embodiment of the threaded insert 130. As shown, the threaded insert 130 can include a cylindrical body 131 having a bore 136 therethrough. The threaded insert 130 may be formed from a rigid or semi-rigid polymeric material. For example, the material can be polycarbonate, high density polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyether ether ketone, or polyoxymethylene. In some embodiments, the material may be reinforced or filled with a filler such as glass. Other materials are contemplated. The bore 136 may include an internal helical insert thread 132 extending along the length of the bore 136. The insert thread 132 may include a single or double thread. The load transfer members 133 may be disposed on both sides of the outer surface of the body 131. The load transfer members 133 can have an arcuate shape to transfer an axial load from the threaded insert 130 to the pressure member 110. In other embodiments, the load transfer members 133 can include any other suitable shape. Further, the slot feature 134 can be disposed on the outer surface of the body 131 between the load transfer members 133.

[0018] FIG. 7 shows the threaded insert 130 coupled to the fluid reservoir 111. As shown, the threaded insert 130 can be disposed within the fluid reservoir 111 while the load transfer members 133 are disposed within the load transfer orifices 114. The slot feature 134 can be disposed within the slot 116 to guide the threaded insert 130 into the fluid reservoir 111. The load transfer members 133 may include a ramp 138 to facilitate placement of the load transfer members 133 within the load transfer orifices 114. The ramp 138 can radially outwardly deflect the flexure member 115 when the threaded insert 130 is inserted into the fluid reservoir 111.

[0019] FIG. 8 shows an embodiment of the grip 140. As shown, the grip 140 can include a body 141 having a bore 142 extending therethrough. The body 141 may 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. The longitudinal channel 143 can be disposed within the bore 142 to receive the rib 117 of the fluid reservoir 111. When the rib 117 is disposed within the channel 143, rotation of the grip 140 relative to the fluid reservoir 111 is prevented. The grip 140 may have an ergonomic shape or surface that allows a user to grasp the grip 140 by hand to prevent the fluid reservoir 111 from rotating when the actuator 170 rotates. For example, in the embodiment shown, the grip 140 includes lobes 144 to provide an ergonomic gripping shape. In other embodiments, the outer surface of the grip 140 can include ridges, dimples, ribs, grooves, texturing, or a soft material. Other ergonomic shapes and surfaces are contemplated within the scope of the present disclosure.

[0020] Figures 9A - 9C show an embodiment of the plunger 150. As shown, the plunger 150 can include a trigger grip 151 and a thread rail 154. The plunger 150 may be formed from a rigid or semi - rigid material such as polycarbonate, high - density polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyether ether ketone, or polyoxymethylene. In some embodiments, the material may be reinforced or filled with a filler such as glass. Other materials are conceivable. The trigger grip 151 may include a grippable shape including a finger grip that is gripped by the user's finger. The proximal plunger ramp 152 can be disposed adjacent to the proximal end of the trigger grip 151 for connection with the proximal actuator ramp of the actuator 170 as described below. The longitudinal rib 153 can be disposed on the outer surface of the trigger grip 151 to maintain alignment with the handle 171 of the trigger grip 151 when the handle 171 moves on the trigger grip 151.

[0021] The thread rail 154 can extend distally from the trigger grip 151. As shown, the thread rail 154 may include a first rail 160 and a second rail 161 that extend parallel to each other. A channel 162 is disposed between the rails 160 and 161. Each of the rails 160, 161 can include protrusions 156, 164 that extend downwardly from the rails 160, 161 respectively. The protrusion 156 of the first rail 160 may be separated by a gap 163, and the protrusion 164 of the second rail 161 may be longitudinally separated by a gap 165. Further, the protrusion 156 of the first rail 160 can be offset longitudinally with respect to the protrusion 164 of the second rail 161. In other words, as shown in FIG. 9C, the cross - section of the thread rail 154 through section 9B - 9B shows the convex portion 156 of the first rail 160 that is aligned transversely with the gap 165 of the second rail 161.

[0022] The distal plunger ramp 157 may be disposed adjacent to the distal end 159 of the threaded rail 154 for engagement with the distal actuator ramp of the actuator 170, as described below. The pin passage 158 can be disposed through the threaded rail 154 adjacent the distal end 159 to receive the coupling pin 123 of the plunger tip 120. The distal end 159 can include a flat head 166 that presses against the engagement member 125 of the plunger tip 120 when the plunger 150 moves distally to pressurize the fluid reservoir 111. Further, the flat head 166 can be slidably connected to the engagement member 125 when the threaded rail 154 is disengaged from the thread insert 130.

[0023] The threaded rail 154 can include a male plunger thread 155 disposed along the length of the threaded rail 154 that selectively engages the insert thread 132 of the thread insert 130. The plunger thread 155 may include an arc length of from about 45 degrees to about 60 degrees and may be about 52 degrees.

[0024] Figures 10A and 10B show two operable positions of the threaded rail 154 relative to the thread insert 130. Figure 10A shows the threaded rail 154 disposed in an engaged position such that the plunger thread 155 is engaged with the insert thread 132. Figure 10B shows the threaded rail 154 in a non-engaged position, where the threaded rail 154 is fully retracted into the thread insert 130 such that the plunger thread 155 is not engaged with the insert thread 132.

[0025] Each of the insert threads 132 includes a proximal flange 132a and a distal flange 132b. Each of the plunger threads 155 includes a proximal flange 155a and a distal flange 155b. The proximal flanges 132a, 155a are configured to engage when the plunger 150 is threaded onto the threaded insert 130. In the illustrated embodiment, the proximal flange 155a of the plunger threads 155 and the proximal flange 132a of the insert threads 132 include an engagement angle β that may be in the range of about 45 degrees to about 90 degrees, and about 70 degrees to about 80 degrees. The pitch of the threads 132, 155 can be from about 8 to about 16 threads per inch. The height of the threads 132, 155 may be from about 0.040 inches to about 0.100 inches. As shown in FIG. 10A, when the plunger threads 155 engage the insert threads 132 and the thread rail 154 rotates, the pressure in the fluid reservoir 111 increases and the proximal force or load acting on the flat head 166 pushes the proximal flange 155a into the proximal flange 132a. This load may 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 orifice 114.

[0026] Figures 11A and 11B illustrate an embodiment of actuator 170. As shown, actuator 170 can include a handle 171 and a plunger guide member 172. Handle 171 and plunger guide member 172 can be formed from a rigid or semi-rigid material such as polycarbonate, polyethylene, polypropylene, nylon, acrylonitrile butadiene styrene, nylon, polysulfone, polyether ether ketone, or polyoxymethylene. In some embodiments, the material may be reinforced or filled with a filler such as glass. Other materials are contemplated. In one embodiment, handle 171 and plunger guide member 172 include a single structure. In other embodiments, handle and plunger guide member 172 include separate components configured to be assembled together. In some embodiments, handle 171 may include a flexible material overmolded to improve the handling of handle 171. Handle 171 can include a bore 184. A channel 185 can be disposed within bore 184 to engage a rib 153 of trigger grip 151 to maintain alignment of handle 171 with trigger grip 151 when handle 171 is moved over trigger grip 151. Further, a proximal actuator ramp 173 can be disposed within bore 184 to engage a proximal plunger ramp 152 of plunger 150 when handle 171 is moved distally relative to trigger grip 151.

[0027] The plunger guide member 172 can extend distally from the handle 171. The plunger guide member 172 can include a first rail 178, a second rail 179, and an intermediate rail 176, and the intermediate rail 176 defines an E-shaped channel 186 that includes 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 can receive the first rail 160, and the second channel 188 can receive the second rail 161 of the threaded rail 154. The intermediate rail 176 can be received within the channel 162 of the threaded rail 154. The distal actuator ramp 174 can be disposed at the distal end of each of the rails 176, 178, 179 so as to engage the distal plunger ramp 157 when the plunger guide member 172 moves distally relative to the threaded rail 154. In other embodiments, one or more intermediate actuator ramps can be disposed along the plunger guide member 172 proximal to the distal actuator ramp 174. The intermediate actuator ramps can be configured to engage one or more intermediate plunger ramps disposed along the plunger 150. The intermediate actuator ramps can facilitate displacement of the intermediate portion of the plunger guide member 172 radially inward. An elastic member 177 (e.g., a compression spring) may be disposed around the proximal portion of the plunger guide member 172. The elastic member 177 can be a compression coil spring that provides a return force to the handle 171. Other types of elastic members are contemplated within the scope of the present disclosure.

[0028] The first channel 187 may include a support inclined portion 189 disposed along the length of the channel 187, and a slot or gap 181 may be disposed between adjacent support inclined portions 189. The second channel 188 may include a support inclined portion 182 disposed along the length of the channel 188, and a slot or gap 183 may be disposed between adjacent support inclined portions 182. The support inclined portion 189 and the support inclined portion 182 may be offset axially. In other words, as shown in FIG. 11B, the support inclined portion 189 is aligned in the short direction with the slot 183. The support inclined portions 182, 189 can engage with the protrusions 156, 164 of the thread rail 154 in order to maintain the engagement between the insert thread of the plunger thread 155 and the insert thread 132 of the insert thread 130 when the expansion device 100 is in a pressurized state. The slots 181, 183 can receive the protrusions 156, 164 in order to enable the plunger thread 155 to disengage from the insert thread 132 when the expansion device 100 is in a depressurized state.

[0029] In use, the expansion device 100 may be utilized to expand an expandable medical device (e.g., a balloon). FIG. 12A shows the expansion device 100 in a pressurized state. As shown, the proximal end of the tube 102 may be connected to the nozzle 113 of the pressurizing member 110, and the distal end of the tube 102 can be connected to a balloon (not shown). The tube 102 may be in fluid communication with the fluid reservoir 111 and the balloon. A fluid (e.g., saline) can be disposed within the fluid reservoir 111. The plunger tip 120 can be disposed within the fluid reservoir 111 and operably connected to the thread rail 154 of the plunger 150. The thread rail 154 is slidably disposed within the plunger guide member 172 of the actuator 170 such that the protrusion 156 of the thread rail 154 engages with the support inclined portion 189 of the plunger guide member 172 and the protrusion 164 (not shown) of the thread rail 154 engages with the support inclined portion 182 (not shown) of the plunger guide member 172 in order to maintain the engagement between the plunger thread 155 of the plunger and the insert thread 132 of the threaded insert 130.

[0030] While in the pressurized state, the handle 171 may be rotated in a clockwise direction by the user's first hand to move the plunger tip 120 distally, while the grip 140 is gripped by the user's second hand to prevent the fluid reservoir 111 from rotating. When the handle 171 is rotated, the threaded rail 154 and the plunger guide member 172 rotate relative to the screw insert 130, and the plunger tip 120 moves distally due to the engagement of the plunger thread 155 with the insert thread 132. When the plunger tip 120 moves distally, the fluid in the fluid reservoir 111 is pushed into the tube 102 and the balloon, and the balloon can be inflated. Since the resistance to inflation is exerted by the balloon, the continuous rotation of the handle 171 can increase the pressure in the fluid reservoir 111. The pressure in the fluid reservoir 111 can apply a proximally directed force or load to the plunger thread 155 and the insert thread 132. The proximally directed force can be transmitted from the insert thread 132 to the fluid reservoir 111 through the load transmission member 133 and the load transmission orifice 114. The pressure in the fluid reservoir 111 can be increased up to about 100 atmospheres. In certain embodiments, the reservoir pressure can be measured with a pressure gauge such as the pressure gauge 112.

[0031] Figure 12B shows the expansion device 100 in a decompressed state. In the decompressed state, the plunger thread 155 can be disengaged from the insert thread 132, allowing the plunger 150 to move freely axially relative to the fluid reservoir 111. In the illustrated embodiment, the actuator 170 can move 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 may be applied by the user's hand. In another embodiment, the distally directed force can be applied by pressing the handle 171 against a rigid surface such as the upper surface of a table. The handle 171 may move distally over the trigger grip 151 to move the plunger guide member 172 distally relative to the threaded rail 154. The support ramp 189 may move distally relative to the projection 156, which is received in the slot 181 and can move the threaded rail 154 vertically downward relative to the longitudinal axis of the expansion device 100.

[0032] 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 move the threaded rail 154 radially inward so that the plunger thread 155 is disengaged from the insert thread 132. The downward movement of the threaded rail 154 releases the proximally directed force applied to the threaded insert 130 and the fluid reservoir 111. The release force applied to the actuator 170 can be from about 2 pounds of force to about 12 pounds of force. Further, the distal end 159 of the threaded rail 154 can be moved downward within the plunger tip 120 relative to the coupling pin 123. When the plunger thread 155 is disengaged from the insert thread 132, the plunger 150 and the actuator 170 can move freely axially, resulting in decompression of the fluid reservoir 111 and the balloon.

[0033] In one embodiment, the free axial movement of the plunger 150 can enable rapid priming of the tube 102 and can enable removal of air bubbles from the fluid reservoir 111. Any method disclosed herein includes one or more steps or operations for performing the described method. The steps and / or operations of the method may be interchanged with each other. In other words, the order and / or use of the specific steps and / or operations may be modified, provided that a particular order of steps or operations is not required for proper operation of the embodiment. For example, a method of pressurizing and depressurizing an inflation device includes moving a threaded rail radially outward to engage a threaded insert, such that a protrusion of the threaded rail engages a support ramp of a guide member; moving the plunger distally toward the distal end of the fluid reservoir to pressurize the fluid within the fluid reservoir; actuating an actuator to move the guide member axially distally relative to the threaded rail; moving the threaded rail radially inward to disengage the threaded insert, such that the protrusion disengages from the support ramp and the guide member engages a plunger ramp; and moving the plunger proximally to depressurize the fluid within the fluid reservoir, and may include one or more of the foregoing steps. Other steps are contemplated.

[0034] References to "one embodiment" or "an embodiment" throughout this specification mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the quoted phrases or variations thereof do not necessarily all refer to the same embodiment.

[0035] Similarly, in the description of the above embodiments, various features are sometimes grouped together in one embodiment, figure, or description for the purpose of streamlining the disclosure. However, the disclosed method is not to be construed as reflecting an intention that any claim requires more features than those explicitly recited in the claim. Rather, as reflected by the following claims, inventive aspects lie in combinations of less than all of the features of any of the above-described disclosed embodiments.

[0036] The phrase "coupled to" refers to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be coupled to each other even if they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

[0037] The terms "distal" and "proximal" are given their ordinary meanings in the art. That is, the distal end of a medical device means the end of the device that is farthest from the operator during use. The proximal end refers to the opposite end, i.e., the end that is closest to the operator during use.

[0038] "Fluid" is used in its broadest sense to refer to both liquids and gases, as well as any fluid that generally behaves as a fluid, including solutions, compounds, suspensions, and the like.

[0039] References to approximations are made throughout this specification, for example by use of the term "substantially". For each such reference, it is understood that in some embodiments, the 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 term being modified in the absence of the modifier. For example, where the term "substantially perpendicular" is used with respect to a feature, in further embodiments, it is understood that the feature may have an exactly perpendicular configuration.

[0040] The terms "a" and "an" are described as one but are not limited to one. For example, although the present disclosure describes a plunger tip having an "O-ring", the present disclosure also anticipates that the plunger tip may have two or more O-rings.

[0041] Unless otherwise specified, all ranges include both endpoints and all numbers between the endpoints.

[0042] The recitation of the term "first" in a claim with respect to a particular 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 various modifications may be made to the details of the above-described embodiments without departing from the basic principles of the invention.

[0043] The patent claims following this description disclosure are hereby expressly incorporated herein by reference, and each claim stands on its own as an independent embodiment. All substitutions of the independent claims are included in the present disclosure together with the dependent claims. Further, additional embodiments that can be derived from the following independent and dependent claims are also expressly incorporated herein by reference.

[0044] Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present invention to its fullest extent. The claims and embodiments disclosed herein should be interpreted as merely descriptive and exemplary, and in no way limit the scope of the present disclosure. It will be apparent to those skilled in the art that, with the aid of this disclosure, changes can be made to the details of the above-described embodiments without departing from the basic principles of the disclosure herein. In other words, various changes and modifications of the embodiments specifically disclosed in the above description are within the scope of the appended claims. Furthermore, the order of steps or actions of the methods disclosed herein can be modified by those skilled in the art without departing from the scope of the present disclosure. In other words, the order or use of specific steps or actions can be modified, unless a specific order of steps or actions is required for the proper operation of the embodiment. The scope of the present invention is therefore defined by the following claims and their equivalents.

Claims

1. An expansion device, A fluid reservoir equipped with a load-transmission orifice, and A load transmission member configured to be disposed within the load transmission orifice, and a threaded insert having a female thread. A pressurizing member comprising, Trigger grip, A thread rail comprising a male thread extending distally from the trigger grip and configured to engage with the female thread of the threading insert, and a projection extending downward from the thread rail, The plunger tip connected to the distal end of the aforementioned thread rail A plunger equipped with, A handle operably connected to the trigger grip, and, A guide member comprising a support inclined portion extending distally from the handle and configured to engage with the projection of the thread rail, and a slot disposed between the inclined portion and configured to receive the projection. An actuator equipped with An inflation device equipped with the following features.

2. The expansion device according to claim 1, wherein the load transmission member and the load transmission orifice are configured to transmit an axial load from the female thread of the threaded insert to the fluid reservoir.

3. The expansion device according to claim 1 or 2, wherein the pressurizing member further comprises a pressure gauge that is in fluid communication with the fluid reservoir for measuring the fluid pressure in the fluid reservoir.

4. The inflation device according to claim 1 or 2, wherein the fluid reservoir further comprises a nozzle that enables the transmission of fluid pressure from the fluid reservoir to an inflatable medical device.

5. The tip of the plunger, circumferential groove, pinhole, An interface member that connects to the distal end of the thread rail, and Distal end face A main unit equipped with, An O-ring disposed within the aforementioned circumferential groove, A pin is disposed at the tip of the plunger through the pin hole to connect the thread rail. An expansion device according to claim 1 or 2, comprising:

6. The expansion device according to claim 5, wherein the distal end face is concave.

7. The expansion device according to claim 5, wherein the transition angle from the distal end face to the inner surface of the fluid reservoir is greater than 90 degrees.

8. The expansion device according to claim 1 or 2, wherein the female thread of the threaded insert and the male thread of the thread rail have an engagement angle of 45 to 90 degrees.

9. The plunger, A distal plunger inclined portion is provided adjacent to the distal end of the aforementioned thread rail, A proximal plunger inclined portion is disposed adjacent to the trigger grip, The U-shaped channel of the thread rail that receives the guide member and The expansion device according to claim 1 or 2, further comprising:

10. The projections are arranged in a first row and a second row along the length of the thread rail, Each of the protrusions in the first row is offset longitudinally from an adjacent protrusion in the first row, and a gap is provided between adjacent protrusions in the first row. Each of the protrusions in the second row is offset longitudinally from an adjacent protrusion in the second row, and a gap is provided between adjacent protrusions in the second row. Each of the protrusions in the first row is offset longitudinally from an adjacent protrusion in the second row. The inflation device according to claim 1 or 2.

11. The actuator, The channel of the guide member that slidably receives the thread rail, A distal actuator inclined portion, which engages with the distal plunger inclined portion, is disposed adjacent to the distal end of the guide member, A proximal actuator inclined portion, which engages with the aforementioned proximal plunger inclined portion, is disposed adjacent to the handle, Support inclined portion disposed within the guide member and The expansion device according to claim 1 or 2, further comprising:

12. The support inclined portions are arranged in a first row and a second row along the length of the guide member. Each of the support inclined portions in the first row is offset longitudinally from the adjacent inclined portion of the first row, and slots are arranged between the adjacent support inclined portions of the first row. Each of the support inclined portions in the second row is offset longitudinally from an adjacent inclined portion in the second row, and the slots are arranged between adjacent support inclined portions in the second row. Each of the support inclined portions in the first row is offset longitudinally from the adjacent support inclined portion in the second row. The expansion device according to claim 11.

13. A threaded insert equipped with a load transmission member, A plunger having an elongated threaded rail that selectively engages with the threaded insert, An actuator comprising a guide member operably connected to the aforementioned thread rail, An inflation device equipped with the following features.

14. The thread rail comprises a plurality of protrusions extending from the bottom surface of the thread rail, The plurality of protrusions are arranged in a first row and a second row along the length of the thread rail, Each of the multiple protrusions in the first row is offset longitudinally from an adjacent protrusion in the first row. A gap is placed between adjacent protrusions. Each of the multiple protrusions in the second row is offset longitudinally from an adjacent protrusion in the second row. A gap is placed between adjacent protrusions. Each of the multiple protrusions in the first row is offset longitudinally from an adjacent protrusion in the second row. The expansion device according to claim 13.

15. The guide member comprises a plurality of support inclined portions disposed within the guide channel, The plurality of support inclined portions are arranged in a first row and a second row along the length of the guide member. Each of the plurality of support inclined portions in the first row is offset longitudinally from the adjacent support inclined portion in the first row, and slots are arranged between adjacent support inclined portions. Each of the plurality of support inclined portions in the second row is offset longitudinally from the adjacent support inclined portion in the first row, and the slots are arranged between the adjacent support inclined portions. Each of the plurality of support inclined portions in the first row is offset longitudinally from the adjacent support inclined portion in the second row. The inflation device according to claim 13 or 14.

16. The inflation device according to claim 14, wherein the plurality of protrusions engage the plurality of support inclined portions to engage the thread rail with the threaded insert when the inflation device is pressurized.

17. The expansion device according to claim 13 or 14, wherein the load transmission member transmits an axial load from the threaded insert to the fluid reservoir when the expansion device is under pressure.

18. The inflation device according to claim 15, wherein the plurality of protrusions are disposed in the slot to disengage the thread rail from the threaded insert when the inflation device is in a depressurized state.

19. A method for pressurizing and depressurizing an expansion device, A step of moving a thread rail radially outward to engage a threading insert, wherein a projection of the thread rail engages with a support inclined portion of a guide member; The steps include moving the plunger distally toward the distal end of the fluid reservoir in order to pressurize the fluid in the fluid reservoir, The steps include: activating an actuator to move the guide member axially distal to the thread rail, A step of moving the thread rail radially inward in order to disengage the thread rail from the threading insert, wherein the projection is disengaged from the support inclined portion and the guide member engages with the plunger inclined portion; The steps include moving the plunger to a proximal position in order to reduce the pressure of the fluid in the fluid reservoir, and Methods that include...

20. The method according to claim 19, further comprising transmitting a proximal load applied to the threaded insert to the fluid reservoir, wherein the proximal load is transmitted via a load transmission member of the threaded insert and a load transmission orifice of the fluid reservoir.

21. The method according to claim 19, further comprising connecting a threaded insert to the fluid reservoir, wherein a load-transmitting member of the threaded insert snap-fits with a load-transmitting orifice of the fluid reservoir.

22. The method according to claim 19, further comprising connecting the thread rail to the tip of the plunger, wherein the thread rail is movable perpendicular to the longitudinal axis of the tip of the plunger.

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