Operating mechanism for fluid transfer pressurization device

Abstract

To provide a screw plunger actuation and drive mechanism to control displacement and pressurization of a working fluid in fluid displacement and pressurizing devices for balloon catheters.SOLUTION: A fluid displacement and pressurization device 19 includes: a syringe body 8; a threaded plunger 1 extending into the syringe body 8 and provided with a longitudinal axis; a piston on the plunger 1, the piston contacting the syringe body 8 in a sealed state; a control button 12 that can be pushed into the plunger 1; a threaded syringe 5; and a pair of control blades for selectively engaging or disengaging the thread of the plunger 1 and the thread of the threaded plunger 5 in accordance with whether or not the control button 12 is pushed. When the threads are departed, the plunger 1 is allowed to be pushed into the syringe body 8 and to be pulled from the syringe body 8 so as to enable macro-movement of the plunger 1 to the syringe body 8.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention generally relates to a fluid transfer pressurization device for a balloon catheter or the like, and more particularly to an improved screw plunger actuating and driving mechanism for controlling the movement and pressurization of a working fluid.

Background Art

[0002] Fluid transfer pressurization devices have been developed heretofore that are adapted to selectively apply and release a measured pressure to a fluid in a closed volume, such as for use in inflating a balloon catheter used in an intravascular angioplasty procedure or other types of balloon catheter procedures.

[0003] Some examples of prior art devices for inflating and deflating a balloon device into which a catheter has been inserted are disclosed in U.S. Patent No. 4,838,864, U.S. Patent No. 5,047,015, U.S. Patent No. 5,168,757, U.S. Patent No. 6,796,959, and U.S. Patent No. 9,492,643.

[0004] The inflation device disclosed in U.S. Patent No. 4,838,864 uses a threaded plunger and a release element configured to selectively threadedly engage and disengage from the threaded plunger. The plunger includes a handle for moving a piston within the device. However, since the release element is not part of the handle, the device is not configured to be used with one hand.

[0005] The inflation device disclosed in U.S. Patent No. 5,047,015 is unique in that it uses a non-threaded plunger. Instead of a threaded plunger, the device uses a narrow, articulated threaded insert strip designed to unfold and engage with surrounding mating threads. The narrow threaded insert strip relies in part on a spring force to maintain engagement under load. Thus, a spring is required to support the load on the plunger during pressurization. This is not ideal because the spring must be large enough to withstand the load on the plunger. For the plunger to handle loads from a large piston or high-pressure device, the spring must withstand plunger loads of 300–500 lbF. The prior art device disclosed in patent 5,047,015 is designed so that the load acting on the plunger is actually supported by a narrow threaded insert that pushes a spring and traverses diagonally toward the center of the plunger. The plunger load pushes the insert in the disengagement direction rather than engagement direction (i.e., proximal to the plunger and toward the center). Thus, the load on the plunger must be resisted by a strong return spring. Furthermore, the threads must be designed to retract within a path neutral to the angle of the thread face so as not to suspend or push the plunger distally (in the pressurizing direction) when the plunger is released from the load so as to traverse obliquely inward. Moreover, this transverse angle must provide some mechanical advantage to the return spring by wedging the thread insert outward. Therefore, the threads must be designed in the exact opposite way to the ideal, by having a larger inclined surface, i.e., a surface parallel to its oblique retraction angle, to support the pressurizing load rather than the opposite thread face which is more perpendicular to the axis of the plunger. For ideal load handling, such a thread design is completely contrary to best practice. As a result of devices that use threaded inserts rather than having threads directly on the plunger, the device cannot withstand substantial plunger loads.Given the geometric limitations of screw inserts (as mentioned above), the only way the strip can cope with more pressure is to use a spring so large that it becomes impractical or impossible to operate manually.

[0006] U.S. Patents 5,168,757, 6,796,959, and 9,492,643 disclose devices for improved injection and pressurization control. All three patents are owned by the assignee of the present invention and are thus incorporated herein in their entirety by reference. These patents disclose rapid-acting mechanisms that enable rapid advancement of a plunger and, as an alternative, enable user-controllable screw engagement of a screw-supported plunger to achieve precise control during final pressurization of a balloon catheter.

[0007] Both Patent No. 757 and Patent No. 959 disclose similar devices for moving a nut member to screw-engage and screw-disengage a threaded plunger. The plunger has a handle, and the plunger's handle and the actuation mechanism for engaging the nut member with the threaded plunger are separate mechanisms. As a result, neither device is configured for one-handed use. In addition, the devices have only a small surface area for screw engagement between the nut member and the threaded plunger, resulting in a larger load per screw compared to cases with a much larger engagement surface area.

[0008] Patent '643 discloses a device configured for one-handed operation. However, the device is similar to those disclosed in patents '757 and '959 in that it provides only a small surface area for screw engagement. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] U.S. Patent No. 4,838,864 [Patent Document 2] U.S. Patent No. 5,047,015 [Patent Document 3] U.S. Patent No. 5,168,757 [Patent Document 4] U.S. Patent No. 6,796,959 [Patent Document 5] U.S. Patent No. 9,492,643 [Overview of the project] [Problems that the invention aims to solve]

[0010] An object of one embodiment of the present invention is to provide a novel operating mechanism for quickly and selectively releasing or engaging a movable threaded plunger that is operable within a threaded member in an integrated syringe body.

[0011] Another object of one embodiment of the present invention is to provide a mechanism configured to control a high-pressure medical syringe for purposes such as pressurizing, depressurizing, and deflating a therapeutic medical balloon catheter.

[0012] A further object of one embodiment of the present invention is to provide a mechanism that brings about rapid manual reciprocating motion of a plunger, locking of the plunger in place, or precise screw-controlled plunger advancement by plunger rotation, as required by the operator, in order to hold, move, pressurize, depressurize, or discharge the working fluid contained in a syringe.

[0013] Another object of one embodiment of the present invention is to provide a device that incorporates a threaded plunger configuration that results in a large surface area for thread engagement.

[0014] A further object of one embodiment of the present invention is to provide a device configured such that the operating load between screw members is transmitted directly by a plunger having a screw thread and not indirectly through any intermediate component. [Means for solving the problem]

[0015] In short, one embodiment of the present invention provides a fluid transfer pressurizer that provides a considerable amount of screw engagement and one-handed control for all operational operations, including maintaining a set filling volume, rapid filling and displacement, and pressurizing and holding the discharge position during balloon depressurization. The device allows the plunger handle to be rotated, pushed, or pulled, as well as to be switched from micro-movement control to macro-movement control using one hand.

[0016] The embodiment comprises a syringe body, a threaded plunger extending into the syringe body, a threaded member inside the syringe body, a control blade, a handle at the end of the plunger, and a control button inside the handle. When the control button is not pressed, the control blade engages the threaded member with the threaded plunger. At that time, the plunger handle is rotatable to allow micro-movement of the plunger. The button inside the handle is pressable to cause the control blade to disengage the threaded member from the threaded plunger inside the syringe body, enabling macro-movement of the plunger by pushing it into or pulling it out of the syringe body.

[0017] The structure and operation and aspects of the present invention, along with its further objectives and advantages, can be best understood by referring to the following description, which is interpreted in relation to the accompanying drawings, where similar reference numerals in the drawings identify similar elements. [Brief explanation of the drawing]

[0018] [Figure 1] This is a perspective view of a fluid transfer pressurizing device according to the first embodiment of the present invention. [Figure 2] Figure 1 is an exploded perspective view of the fluid transfer pressurization device shown. [Figure 3] These are cross-sectional views of a portion of the apparatus shown in Figures 1 and 2, showing a plunger locked in a threaded engagement state with a threaded cylinder. [Figure 4]Similar to FIG. 3, it shows a plunger moved from a screw engagement with a threaded cylinder. [Figure 5] It shows specific components of the fluid transfer pressurizing device when a button at the end of the fluid transfer pressurizing device is pressed. [Figure 6] Similar to FIG. 5, it shows components when the button at the end of the fluid transfer pressurizing device is not pressed. [Figure 7] It effectively shows the movement of the control blade during the operation of the fluid transfer pressurizing device. [Figure 8] It effectively shows the movement of the control blade during the operation of the fluid transfer pressurizing device. [Figure 9] It is a cross-sectional view of the fluid transfer pressurizing device shown in FIGS. 1 and 2. [Figure 10] It is an enlarged view of a part of the portion shown in FIG. 9. [Figure 11] It is a cross-sectional view similar to FIG. 3, showing a pressurized device, and relates to a second embodiment of the present invention. [Figure 12] It shows a part of FIG. 11 in more detail. [Figure 13] It is a cross-sectional view similar to FIG. 4, showing a released pressure, and relates to a second embodiment of the present invention. [Figure 14] It shows a part of FIG. 13 in more detail.

Mode for Carrying Out the Invention

[0019] Although this invention may have room to accept various forms of embodiments, while understanding that the present disclosure should be regarded as an exemplification of the principles of the present invention and not as an attempt to limit the present invention to what is exemplified, specific embodiments are shown in the drawings and described in detail here.

[0020] Figure 1 shows a fluid transfer pressurizing device 19 according to a first embodiment of the present invention. Preferably, the handle 13 of the plunger 1 is located at one end of the fluid transfer pressurizing device 19, while the other end of the fluid transfer pressurizing device 19 is configured to engage with a high-pressure fluid delivery hose 49 (i.e., engage via a conventional hose engagement socket or the like). As shown in the figure, for example, a Luer connector 48 that can be connected to a fitted balloon catheter (not shown) or some other therapeutic medical device may be located at the end of the high-pressure fluid delivery hose 49.

[0021] Preferably, the fluid transfer pressurizer 19 includes an integrated syringe body 8, and the plunger 1 extends within the integrated syringe body 8. As will be described in more detail later herein, the fluid transfer pressurizer 19 is configured such that the plunger 1 can be translated relative to the integrated syringe body 8 by either pushing or pulling the plunger handle 13 or rotating the plunger handle. The translation of the plunger results in pressurization or depressurization of a fitted balloon catheter (or other therapeutic medical device) connected to a Luer connector 48 at the end of a high-pressure fluid delivery hose 49.

[0022] Preferably, the integrated syringe body has a barrel 7, which is completely transparent (at least in the barrel 7) to monitor the amount of working fluid in the barrel 7 and to facilitate both fluid filling and purging of trapped and drawn-in air in preparation for use. As shown in Figure 1, the barrel 7 may have a volume indicator on it.

[0023] Generally, medical fluid pressurizing devices, such as those disclosed in the prior art patents referenced above, are equipped with a pressure monitoring function. Most commonly, these devices are equipped with conventional mechanical pressure gauges. These types of self-contained pressure gauges generally have their own threaded spigots, protective cases, and lenses, which are, in most cases, fixed to the device by threaded sockets or snap ring retaining mechanisms. Furthermore, they often have to be held in place with adhesive, regardless of their primary retaining means, to prevent rotation during use.

[0024] In contrast, the medical fluid pressurizing device 19 disclosed herein preferably comprises a pressure monitoring mechanism in the form of a gauge module 30. Preferably, the gauge module 30 comprises the most basic components of a mechanical gauge, consisting simply of a Bourdon tube, a clockwork mechanism, an indicator hand, a dial, and a fluid communication port. Preferably, the gauge module does not include any form of threaded socket, housing, or protective lens, and once installed, does not require the use of any binder to prevent rotation.

[0025] Alternatively, preferably, the gauge housing 31 protects the working elements of the gauge module 30, and the gauge housing 31 is preferably provided as an integral feature of the integrated syringe body 8. Preferably, as shown in Figure 2, the gauge module 30 is secured within the housing 31 by self-tapping retaining screws 33, and the lens 32 is configured to snap into place on the gauge module housing 31 to protect the dial of the gauge module 30.

[0026] As shown in Figure 1, the fluid transfer pressurizer 19 includes a control button 12, and it is preferable that the control button 12 is located at the end of the fluid transfer pressurizer 19 on the handle 13 of the plunger 1. As will be described in more detail below, when the control button 12 is pressed, the fluid transfer pressurizer 19 transitions from micro-movement control (i.e., achieved by rotating the plunger handle 13) to macro-movement control (i.e., achieved by pushing or pulling the handle 13 so that the plunger 1 is translated further into or out of the integrated syringe body 8).

[0027] Figure 2 shows an exploded view of the fluid transfer pressurizing device 19. As shown in the figure, the fluid transfer pressurizing device 19 also includes a threaded member 5, preferably in the form of a threaded cylinder, a plurality of control blades (specifically, thread control blades 3 and thrust control blades 4), a spring 14, a pair of lock keys 36, a piston 6, and a seal ring 29, preferably in the form of a rubber O-ring.

[0028] As shown in Figures 3 to 9, the piston 6 engages with the end of the plunger 1, and the seal ring 29 is positioned on the piston 6 to seal against the inner wall of the barrel of the integrated syringe body 8 (as shown in Figures 3 and 4).

[0029] The integrated syringe body 8 is configured to hold the threaded cylinder 5 and guide and engage with a plunger 1 that is operable within the threaded cylinder. The plunger 1 preferably includes a fixed thread 2 along its entire operating length.

[0030] This disclosure describes a fluid transfer pressurizing device 19 that includes a novel operating mechanism for quickly and selectively disengaging or releasing a movable threaded plunger 1 that is operable within a fixed female-threaded cylinder 5 in an integrated syringe body 8. The mechanism is particularly suitable for controlling a high-pressure medical syringe for purposes such as pressurizing, depressurizing, and deflating a therapeutic medical balloon catheter. The mechanism includes a threaded plunger 1 having a piston 6 positioned at one end so as to traverse the barrel portion of an integrated syringe body 8, a handle 13 with a control button 12 at the other end of the plunger 1 (i.e., opposite the piston 6), and means provided within the plunger 1 to allow an operator to selectively engage and disengage the threaded plunger 1 from the threaded cylinder 5 by operating the control button 12 located within the plunger 1. This mechanism allows for rapid manual reciprocating motion of plunger 1, locking of plunger 1 in place, or precise screw-controlled plunger advancement by plunger rotation, as required by the operator, in order to hold, move, pressurize, depressurize, or discharge the working fluid contained within the syringe.

[0031] The fluid transfer pressurizer 19 has a threaded plunger 1, which is driven into an engaged state by a thrust control blade 4. The thrust control blade 4 first moves axially across until its cam follower passes the cam, and then moves inward toward the center of the plunger to release the threaded engagement of the plunger. This complex movement is not possible with a threaded insert.

[0032] Unlike the prior art syringe devices referenced in the previously cited U.S. patent, the fluid transfer pressurization and expansion device 19 disclosed herein and shown in Figure 1 utilizes a novel user-selectable plunger control mechanism that does not rely on the movement of any form of half-nut, the protrusion or recession of a threaded support insert strip within the plunger, or the expansion of a threaded segment. Instead, the mechanism, as shown in Figure 2, utilizes a rigid load-bearing plunger 1 having fixed threads 2 along its entire operating length and a pair of control blades 3, 4, the pair of control blades 3, 4, the outer edges of which are parallel to the longitudinal axis of the plunger 1 and configured to selectively engage or disengage the threads 2 of the plunger 1 with the threads 15 in the threaded cylinder 5. The control blades 3, 4 are positioned to selectively bring about, maintain, or facilitate the disengagement of the thread engagement between the threads 2 of the plunger 1 and the threads 15 in the threaded cylinder 5 (see Figures 3 and 4).

[0033] The control blades 3 and 4 can lock the plunger 1 and its mounted piston 6 in a desired position within the syringe barrel bore 7 of the integrated syringe body 8 to provide thread-assisted micro-movement, or release this engagement to allow macro-movement. When the plunger 1 is locked into a threaded engagement with the threaded cylinder 5 (as shown in Figure 3, which is cut off-center for better feature illustration), precisely controlled macro-advance and retraction of the plunger 1 becomes available by the rotation of the plunger (i.e., by rotating the handle 13). On the other hand, whenever the control button 12 is pressed (see Figure 5), the control blade 3 releases and prevents the engagement between the plunger threads 2 and the threads 15 of the threaded cylinder 5 (as shown in Figure 4, which is cut off-center for better feature illustration), in order to facilitate free macro-movement of the plunger 1 (i.e., movement by pushing or pulling the handle 13).

[0034] Generally, the control blades 3 and 4, positioned 180° apart from each other and along the entire length of the plunger 1, are preferably provided with tabs 9 and 10 for engaging with the hooks 11 of the control button 12 located within the handle portion 13 of the plunger 1. Furthermore, as shown in Figure 6, the control button 12 includes a spring 14 that contacts the handle 13 to maintain the thread engagement between the plunger 1 and the threads 15 of the surrounding threaded cylinder 5 by driving the control button 12 outward to position the control blades 3 and 4 in place.

[0035] Each of the control blades 3 and 4 has unique and specific features specific to the purpose they serve, as well as several common features, and each resides within its own dedicated and unique longitudinal guide groove within the plunger 1. Specifically, as shown in Figure 7, the thrust control blade 4 is located on the opposite side of the thread 2 of the plunger 1 and operates within the guide groove 17. The thread control blade 3, on the other hand, is located along the center of the thread 2 on the plunger 1 and operates within the guide groove 16. Preferably, both control blades 3 and 4 are designed to translate laterally outward from the plunger 1 over a distance equal to the depth of the thread 2, depending on the position of the control button 12.

[0036] As shown in Figure 8, the shaft of plunger 1 can be geometrically divided into two zones (Z1 and Z2) by a longitudinal geometric plane (shown in Figure 8 using dashed lines) that passes through the longitudinal axis, in which case the first zone (Z1) of the two zones contains the threads 2 of plunger 1, and the second zone (Z2) of the two zones does not contain the threads.

[0037] Preferably, the control blade 3 is simpler than the control blade 4 and effectively has four functions: a) to assist in the release of the plunger threads 2 from screw engagement with the mating threads 15 on the threaded cylinder 5; b) to prevent undesirable re-engagement of these threads; c) to shift the axis of rotation of the plunger 1 so as not to align with the central axis of the threaded cylinder 5 during disengagement from the threads 2 on the plunger 1 to the threads 15 in the threaded cylinder 5; and d) to shift the axis of rotation of the plunger 1 so as not to align with the central axis of the piston 6 at the end of the plunger 1.

[0038] The shift of the rotation axis of the plunger 1 away from alignment with the central axis of the threaded cylinder 5 is initiated by the user's compression of the control button 12 and is handled by a laterally sliding coupling provided between the distal end of the plunger 1 and the piston 6. This coupling consists of a "T" shaped functional part 41 at the distal end of the plunger 1 that engages with a fitting T-slot receptacle 42 at the proximal end of the piston 6 (as used herein, the term distal refers to the point furthest from the operator, while the term proximal refers to the point closest to the operator). An off-axis shift is required, driven by the thread control blade 3 pushing the closed end 44 of the piston T-slot receptacle 42. This is because the entire plunger 1 must be shifted laterally by an amount equal to the depth of the thread 2 of the plunger in order to disengage the thread 2 of the plunger from the thread 15 of the threaded cylinder 5.

[0039] As shown in Figure 8, the lifter tip 43 is positioned on the tip of the control blade 3, and the lifter tip 43 is positioned to cause this lateral shift between the plunger 1 and the piston 6 whenever the lifter tip 43 pushes the "T" shaped functional part 41 of the plunger 1 away from the closing end 44 of the T-slot receptacle 42. This off-axis shift of the plunger 1 relative to the positions of the control blades 3,4 must also be addressed by the control button 12, as shown in Figure 5. The control button 12 is housed within the plunger handle 13 but is not constrained to strict longitudinal axial movement. Instead, the control button 12 is configured to float within the range of the plunger handle 13, and therefore remains attached to the control blades 3 and 4 whenever the plunger 1 shifts from its on-axis position with threads 2 and 15 engaged in the off-axis position whenever the control button 12 disengages the threads, and follows along with the control blades 3 and 4.

[0040] Conversely, the restoration of axial alignment between the plunger 1 and the central axis of the thread 15 and piston 6 occurs when the thrust control blade 4 pushes the tip 46 of the thread 15 (see Figures 3 and 4). Whenever the control button 12 is released after being pressed, the thrust control blade 4 (more complexly composed of two control blades 3 and 4) pushes outward away from the center of the plunger 1, as shown in Figure 3, thereby pulling the thread control blade 3 inward toward the center of the plunger 1. This action shifts the central axis of the plunger 1 into a concentric alignment with the central axes of the piston 6 and thread 15, thereby bringing the thread 2 of the plunger 1 into a locked engagement with the mating thread 15 as the thread control blade 3 retracts toward the center of the plunger 1 (shown in Figure 3). Furthermore, the control blade 4, once deployed, also serves to counteract the lateral thrust generated by these engaged threads, such as when the plunger 1 is rotated to drive the piston 6 distally into the cylinder bore 7 to the operating pressure in the expansion device 19. The control blade 4 is preferably provided with a wide support surface 45 that delivers the lateral thrust of the engaged threads to the tip 46 of the threads 15 under load. Lateral shift of the plunger 1 resulting from the action of the control blade 4 while the operator releases the control button 12 is addressed by a sliding coupling between the T-slot receptacle 42 of the piston 6 and a T-shaped functional part 41 located at the distal end of the plunger 1. Since the thrust control blade 4 and the thread control blade 3 operate synchronously with each other, when the operator releases the control button 12, the lifter tip 43 is simultaneously pulled away from the closed end 44 of the piston T-slot receptacle 42.

[0041] To ensure synchronous operation between the control blades 3 and 4, the thread control blade 3 and the thrust control blade 4 are preferably joined to each other by interlocking functions 25 provided at the ends of a series of inclined fingers 18 and 20 (shown in Figures 7 and 9), corresponding to the blades 3 and 4. The interlock of the inclined fingers 18 and 20 ensures that the opposing blades operate as a unit whenever the control button 12 is activated. These joinable fingers engage into an interlocking relationship when both control blades 3 and 4 are fully inserted into their designated guide grooves 16 and 17 and their respective inclined fingers 18 and 20 meet within an array of inclined receiving slots 21 (see Figure 10) provided for them in the plunger 1. The receiving slots 21 are preferably configured with sufficient clearance and elasticity to allow the interlocking functions 25 of the inclined fingers 18 and 20 to bypass each other when sufficient compressive assembly force is applied to the outer edges of each control blade to cause them to engage. When the inclined fingers snap into engagement with each other within the tight-fitting range of the receiving slots 21, the interconnection of the interlocking functional parts 25 of the inclined fingers is preferably maintained by the tight fit of the finger receiving slots 21 into which they were initially inserted.

[0042] The solid web 40 of the plunger 1, which separates each of the finger receiving slots 21 and joins the guide grooves 16, 17, extends parallel to the interlocked inclined fingers 18, 20 of the control blades 3, 4. The proximal and distal edges 24 and 23 of the solid web 40 form the boundaries of the receiving slots 21 and also function as ramps, so that whenever the control blades 3, 4 are moved forward or backward in the longitudinal direction, i.e., along the axis of the plunger 1, the distal and proximal edges 27 and 26 of the assembled inclined fingers 18, 20 are guided on the ramps during movement.

[0043] The angle at which the interlocked inclined fingers 18, 20 are aligned (shown in Figure 9), i.e., the finger angle 47, determines the amount of lateral displacement obtained by the control blades 3, 4 to disengage the plunger threads 2 from the threads 15 in the threaded cylinder 5, in response to the longitudinal operator-applied movement of the control button 12.

[0044] The selection of this angle is determined by the desired output response to a given operator input. The finger angle 47 can preferably be in the range of 22.5° to 67.5°, in which case an angle close to 45° is most preferred. Positioning the inclined fingers 18, 20 and their respective finger receiving slots 21 at 45° with respect to the longitudinal axis of the plunger results in, for example, a translational movement of the control blades 3, 4 equal to the longitudinal movement of the control button 12, and requires a button input force equal to the lateral thrust generated by the plunger threads 2 while loaded (regardless of friction or the force of the control button spring 14). An angle sharper than 45° with respect to the axis of the plunger 1, such as 22.5°, requires a user force acting on the control button 12 equal to half the lateral thrust given by the plunger 1 when loaded (regardless of friction and the force of the spring 14), but also twice the longitudinal movement of the control button 12 to obtain the required lateral translational movement of the control blades 3, 4. An angle no sharper than 45° with respect to the axis of plunger 1, such as 67.5°, requires a user force acting on the control button 12 equal to 3 / 2 of the lateral thrust provided by plunger 1 when loaded (despite the forces of friction and spring 14), but also requires 2 / 3 of the longitudinal movement of the control button 12 to obtain the required lateral translational movement of the control blades 3, 4. Therefore, the angular arrangement of the inclined fingers 18, 20 and the receiving slot 21 may be selected to accommodate the user's expectations or requirements. Other factors influencing this angle selection are the amount of interconnection of the inclined fingers required to locally support the thrust blade 4 when plunger 1 is placed under pressurized load, the width of the inclined fingers 18, 20, and the size of the web 40 required to meet the plunger strength requirements.

[0045] To ensure that the spring 14 is light enough for comfortable use, the spring must be isolated from the reaction load force acting on the thrust control blade 4 that occurs whenever the plunger thread 2 is subjected to an operating load while the device is pressurized. Therefore, preferably, as best shown in Figure 3, the plunger 1 has a guide groove 17 that leads to a series of thrust blade control cams 28, and preferably, the thrust blade 4 includes a series of cam followers 22 appropriately positioned to ride up onto and bear against the mating thrust blade control cams 28. This arrangement of cams and cam followers provides the thrust control blade 4 with localized rigid support at a position adjacent to the support surface 45 while in contact with the thread tip 46 of the threaded cylinder thread 15. This places the plunger 1 under lateral compression, thereby eliminating the need for the spring 14 to support any reaction loads received by the thrust control blade 4 when the plunger 1 is subjected to a load while the device is pressurized.

[0046] During pressurization of the expansion device 19, the threaded cylinder 5 is relied upon (by the rotational engagement of the plunger threads 2 within the threads 15 of the threaded cylinder 5) to drive the plunger 1 (and therefore the piston 6 and pressure seal 29 as well) distally along the syringe barrel bore 7. The force of the plunger 1 on the threaded cylinder 5 resulting from this type of pressurization attempts to drive the threaded cylinder 5 proximal toward the operator. Therefore, means must be included to fix the threaded cylinder 5 to the integrated syringe body 8 and to directly transmit the resulting load of thread-driven pressurization to the integrated syringe body 8.

[0047] For this purpose, it is preferable to use the lock key 36 to engage the lock key notch 37 of the threaded cylinder 5 with a corresponding lock key receiving port 38 provided along the side of the integrated syringe body 8. The lock key 36 is preferably configured to snap securely into place within the lock key receiving port 38 of the integrated syringe body 8. The lock key 36 can also provide an ideal platform for incorporating further functional parts, such as a lock key mounting grip 39 as shown in Figure 2. This simple type of grip (or even a larger, more complex handle form) can be used to allow the user to firmly grip the inflation device 19 during operation and handling.

[0048] The bodies and barrels of the types of pressurized syringes disclosed herein may be formed from a variety of proprietary resins, but most typically they are made from commonly available and injection-molded polycarbonate resins, which have high transparency, high impact resistance, superior strength compared to most other transparent resins, and a reasonable cost in light of their performance characteristics. However, the use of convenient self-tapping screws often presents design challenges to assemblies formed from these engineering resins, due to the internal stresses in the resin generated by such fasteners. One significant drawback of polycarbonate resins is that they generally cannot withstand long-term stress under loads associated with the use of self-tapping fasteners. Therefore, polycarbonate resins are often an undesirable resin choice whenever the use of self-tapping screws is desired. In such cases, alternative materials with higher costs and lower strengths can often be used, but utilizing these alternatives generally forces designers to accept less desirable compromises in material properties and cost. The design (and intended performance characteristics) of embodiments of the present invention makes polycarbonate resin the material of choice. However, alternative solutions are needed to enable the use of self-tapping retaining screws 33 to secure the gauge module 30. One option is to form threads on the gauge receiving structure 35, but forming small threads on this type of component requires a very complex, costly, and maintenance-intensive mold structure. Another alternative (as described herein) is the use of a gauge module retaining insert 34 formed from a material such as ABS, nylon, or copolyester, including reinforced varieties of these materials that can withstand stress from the self-tapping screws. When formed from such a material, this insert is highly robust and unaffected by the stress of the self-tapping screws. Thus, the gauge module retaining insert 34 enables the use of other desirable materials, such as polycarbonate resin, for the body of the expansion device 19.In addition to providing anchors for self-tapping screws, the gauge module retaining insert 34 can function as part of the protective gauge housing. Furthermore, since the gauge module retaining insert 34 can be manufactured in various colors, it can also serve as a unique decorative and differentiating functional part for the expansion device 19.

[0049] The advantages for the user of this device structure include one-handed control of the plunger 1 for all operational operations, including set filling volume, rapid filling and movement, thread-assisted pressurization, and holding of discharge position during balloon depressurization. Unlike prior art devices such as those described in U.S. Patent No. 5,047,015, the operation of the device control by the plunger mechanism is easily achieved when performing any of the intended operating procedures. This is because the return spring 14 of the control button is not required to support any of the plunger loads during pressurization. Furthermore, this device structure can also feed into the piston 6 and maintain very high plunger force loads, but this can be done with comfortable user control input. The threaded plunger configuration of this device results in a large surface area of ​​thread engagement (e.g., more than twice the surface area of ​​the prior art devices discussed earlier by the applicant), and therefore enjoys a much lower load per unit of thread surface area. Furthermore, since the plunger threads 2 are part of the plunger 1, the operating load between the piston 6 and the threaded member 5 of the device housing that engages with the plunger 1 is transmitted directly by the plunger 1 and not indirectly through attached components as in the case of a threaded insert strip. This allows for plunger loads exceeding 300 LbF, and potentially exceeding 500 LbF, making it possible to construct high-capacity, high-pressure devices to meet the need for novel and improved therapeutic balloons.

[0050] Figures 11 to 14 relate to a second embodiment of the present invention. Specifically, Figure 11 is a cross-sectional view similar to Figure 3 showing a pressurized device, and Figure 13 is a cross-sectional view similar to Figure 4 showing the released pressure. Figures 12 and 14 show parts of Figures 11 and 13 in more detail, respectively.

[0051] The embodiments shown in Figures 11 to 14 are very similar to the previous embodiments, so only the differences will be described, and the same part numbers will be used to identify similar parts. For example, similar to the first embodiments shown in Figures 1 to 10, the second embodiments shown in Figures 11 to 14 include thread control blades 3, 4, a threaded cylinder 5 having threads 15, a control button 12, an inclined finger 18, and a lifter tip 43.

[0052] Compared to the first embodiment, the second embodiment is a preferred embodiment and includes both an improved plunger 151 and an improved piston 161. These improvements provide an improved interface that greatly enhances user control, as well as providing plunger stability relative to the piston to improve sealing performance and enabling higher plunger loads.

[0053] Compared to the first embodiment shown in Figures 1 to 10, the second embodiment shown in Figures 11 to 14 results in better centering of the plunger 151 within the piston 161 during device pressurization, particularly when the plunger threads engage with and load the threaded cylinder element 5. Better centering helps ensure a more uniform sealing load for higher pressure sealing performance. As previously disclosed, the plunger threads 2 are driven laterally by a thrust control blade 4 to engage with the threaded cylinder 5, thereby the thrust control blade 4 establishes the rotation axis of the engaged plunger and aligns this rotation axis with the central axis of the piston. The improved plunger-piston interface, related to the embodiments shown in Figures 11-14, releases the plunger-side load on the piston 161 by the thrust control blade 4 during pressurization of the apparatus (shown in Figures 11 and 12), reduces the transition-release movement of the thread control blade 3 relative to the piston 161 during depressurization of the apparatus (shown in Figures 13 and 14), and ensures that the rotation axis of the plunger 151 remains parallel to the common axis of the apparatus throughout its lateral movement. Furthermore, this interface ensures the axial alignment of the piston 161 and plunger 151 relative to each other during pressurization (shown in Figures 11 and 12), and more precise alignment of the plunger 151 and threaded cylinder 5 during engagement between the plunger 151 and the threaded cylinder 5. The rigidity of the improved piston-plunger interface provided by the second embodiment is further enhanced when the working fluid pressure generated during the operation of the apparatus tightly compresses the individual components together, causing them to operate as a single unit rather than two separate components. Improvements related to the second embodiment include plunger and piston elements of the apparatus, but the function of these improved components still depends on their interaction with components that remain unchanged with respect to the first embodiment. As will become apparent in the following description, the basic function and operation between the two embodiments remain unchanged.

[0054] Similar to the first embodiment, the second embodiment provides that when the user compresses the control button 12 to extend the thread control blade 3 outward and simultaneously retract the thrust control blade 4 inward, the threads of the plunger are disengaged by shifting the axis of rotation of the plunger so as not to align with the central axis of the threaded cylinder 5. With respect to the second embodiment, the shift of the axis of rotation of the plunger 151 by the piston 161 is addressed by a laterally slidable connection between the distal tip 155 of the plunger 151 and the proximal end of the piston 161. As best shown in Figures 11 and 12, the improved piston-plunger connection relies on the distal receptacle sleeve 162 of the piston 161, in which case the receptacle sleeve 162 preferably has a tubular shape having parallel flat side walls 163 joined by a semicircular wall 164 that receives the distal end of the plunger 151. As shown in the figure, preferably, each of the parallel, flat side walls 163 of the receptacle sleeve 162 is provided with a receptacle slot 166 positioned at a suitable angle. As shown in Figure 11, preferably, the bottom of the receptacle sleeve 162 is configured with a plunger centering function that forms a pair of symmetrical, flat, angled ramps 165 located centrally at the base of the receptacle sleeve 162. These angled ramps 165 are preferably positioned such that the small angle between their planes is ideally at least twice the thrust surface angle 159 of the plunger thread 152.

[0055] Preferably, the distal tip 155 of the plunger 151 has a pair of flat parallel sides 153 for tight mating with the receptacle sleeve 162, each of which has an inclined retaining hook 154 for engaging with and holding the inclined receptacle slot 166 of the receptacle sleeve 162. Preferably, the distal tip 155 of the plunger 151 further has two obliquely positioned planes, as shown in Figure 11, comprising an abutment plane 156 and a sliding guide plane 157, each of which is positioned to closely align and engage with the inclined ramp 165 in the receptacle sleeve 162. These two obliquely positioned planes are preferably oriented perpendicular to the flat parallel sides 153 of the plunger 151 and preferably arranged symmetrically around the axis of rotation of the plunger 151, in which case the axis is established when the plunger threads 152 engage with the threads 15 of the threaded cylinder 5. The two flat end faces of the distal tip 155 of the plunger 151 are preferably further positioned such that the contact plane 156 is adjacent to the edge of the plunger 151 containing the thread control blade 3, and the sliding guide plane 157 is adjacent to the edge of the plunger 151 opposite the thread control blade 3. The contact plane 156 and the sliding guide plane 157 are preferably positioned symmetrically with respect to an angle of reference about the rotation axis of the plunger 151, ideally equal to but greater than the thrust surface angle 159 of the plunger thread 152. Thus, the ideal angle of reference between the contact plane 156 and the sliding guide plane 157 is equal to or greater than twice the thrust surface angle of the plunger thread 152, and in all cases is identical to the angle of reference between the inclined ramps 165 with which they closely engage.

[0056] During operation, pressing the control button 12 causes the thread control blade 3 (with the lifter tip 43) to extend laterally to release the plunger thread 152 from engagement with the thread 15 of the threaded cylinder 5. The resulting lateral movement of the lifter tip 43 pushes the plunger 151 away from the semicircular wall 164 of the piston receptacle sleeve 162, as shown in Figures 13 and 14, thereby causing the end of the distal tip 155 of the plunger 151 to traverse the piston receptacle sleeve 162 and move away from axial alignment with the piston 161. This movement ensures that the thread 152 of the plunger 151 remains parallel to the thread 15 of the threaded cylinder 5 at all times. When the threads 152 of the plunger 151 are released from engagement with the threads 15 of the threaded cylinder 5, the direction of movement of the distal tip 155 of the plunger 151 relative to the piston 161 is determined by the engagement of its inclined retaining hook portion 154 with the receptacle slot 166, and the interface between its sliding guide plane 157 and the surface of the inclined ramp 165 with which it abuts. Preferably, both the inclined retaining hook portion 154 and their respective engaging receptacle slots 166 are positioned parallel to the sliding guide plane 157 of the plunger 151.

[0057] The direction of movement of the lifter tip 43 of the thread control blade 3 is determined by the inclined fingers 18 of the thread control blade 3. Therefore, whenever the thread control blade 3 is activated by pressing the control button 12, the lifter tip 43 moves distally as it moves laterally away from the axis of rotation of the plunger 151. As a result, this movement of the lifter tip 43 attempts to push the plunger 151 axially away from the piston 161, and at the same time, the plunger is pushed laterally away from the adjacent semicircular wall 164 of the receptacle sleeve 162. Since the plunger 151 and the piston 161 are held together by the engagement of the inclined retaining hook portion 154 that grips the receptacle slot 166, the longitudinal movement of the lifter tip 43 of the thread control blade 3 must be corresponded to axial sliding against the adjacent semicircular wall 164 of the receptacle sleeve 162. The friction generated by the lifter tip 43 of the thread control blade 3 sliding against the semicircular wall 164 increases the user input force required to press the control button 12 during the initial stage of pressure release. However, as shown in Figure 13, due to the subtractive orientation imposed by the guide plane 157 sliding against the contact surfaces of the inclined receptacle slot 166 and inclined ramp 165, the overall longitudinal sliding distance of the lifter tip 43 against the semicircular wall 164 is smaller than its overall longitudinal extension. Therefore, the reduced sliding distance of the lifter tip 43 reduces the duration of frictional resistance faced by the user when pressing the control button 12 to release pressure from the device.

[0058] Each embodiment features a fluid transfer pressurizer that provides a considerable amount of screw engagement and one-handed control for all operational operations, including maintaining a set filling volume, rapid filling and displacement, and pressurizing and holding the discharge position during balloon decompression. Each embodiment not only transitions the device from micro-movement control to macro-movement control but also enables one-handed use with respect to rotating, pushing, or pulling the plunger handle.

[0059] While specific embodiments of the present invention have been illustrated and described, it is expected that those skilled in the art can devise various modifications without departing from the spirit and scope of the present invention. [Explanation of symbols]

[0060] 1 Plunger 2 threads 3. Thread control blade 4. Thrust control blades 5. Threaded cylinder 6 pistons 7 barrel / cylinder bore 8. Integrated syringe body 9 tabs 10 tabs 11 hooks 12 control buttons 13 Handle 14 springs 15 threads 16 guide grooves 17 Guide groove 18. Angled Fingers 19. Fluid transfer pressurization and expansion device 20. Angled Fingers 21 Acceptance Slots 22 Cam follower 23 Distal margin 24 Proximal margin 25 Interlock function unit 26 Proximal margin 27 Distal margin 28. Thrust blade control cam 29 Seal ring 30 gauge module 31 Housing 32 lenses 33 Self-tapping retaining screws 34 Gauge module retaining insert 35 gauge acceptance structure 36 Lock Key 37. Lock key cutout 38 Lock key acceptance ports 39 Lock Key Mounting Grip 40 Web 41 Functional Section 42 T-slot receptacle 43 Lifter Tips 44 Closed end 45 Support surface 46 chips 47 Finger angle 48 Lure Connectors 49. High-pressure fluid delivery hose 151 Plunger 152 threads 153 Parallel side 154 Incline retention hook 155 distal tip 156 Contact plane 157 Sliding guide plane 159 Thrust plane angle 161 Piston 162 Receptacle Sleeves 163 Side wall 164 Semicircular Wall 165 Inclined ramp 166 receptacle slots

Claims

1. Syringe body and A plunger extending into the syringe body, wherein the plunger has a screw thread and a longitudinal axis, and has a groove for separating the screw thread, The piston on the plunger is in contact with the syringe body in a sealed state, A control button that can be pushed into the plunger, The threaded cylinder inside the syringe body, wherein the threaded cylinder has threads, A pair of control blades configured to selectively engage and disengage the threads of the plunger and the threads of the threaded cylinder, depending on whether the control button is pressed. Equipped with, One of the control blades is positioned along the threads of the plunger and operates within a groove that separates the threads, When the threads of the threaded cylinder engage with the threads of the plunger, the plunger becomes rotatable to cause micro-movement of the plunger relative to the syringe body. When the threads of the threaded cylinder are disengaged from the threads of the plunger, the plunger can be pushed into the syringe body and pulled out from the syringe body, resulting in macroscopic movement of the plunger relative to the syringe body. Fluid transfer pressurization device.

2. The plunger comprises a shaft along the longitudinal axis, The shaft can be geometrically divided into two zones by a longitudinal geometric plane that passes through the longitudinal axis, The first of the two zones is provided with the threads of the plunger. The second of the two zones mentioned above does not include threads. The fluid transfer pressurizing device according to claim 1.

3. The fluid transfer pressurizing device according to claim 1, wherein the pair of control blades comprises thrust control blades configured to move inward toward the longitudinal axis of the plunger to disengage the threads of the threaded cylinder from the threads of the plunger.

4. The fluid transfer pressurizing device according to claim 1, wherein the control button engages with the control blade to move the control blade proximal and distal in the longitudinal direction.

5. The handlebars and A spring that contacts the handle and pushes the control button out of the handle. The fluid transfer pressurizing device according to claim 1, further comprising the following:

6. The plunger comprises a groove for separating the screw threads and other grooves, One of the control blades is positioned in the other groove. The fluid transfer pressurizing device according to claim 1.

7. The fluid transfer pressurizing device according to claim 6, wherein the other groove is located on the opposite side of the threads on the plunger.

8. The fluid transfer pressurizing device according to claim 1, wherein when the control button is pressed, the device is configured to shift the rotation axis of the plunger away from the central axis of the threaded cylinder.

9. The fluid transfer pressurizing device according to claim 1, wherein the piston and the plunger are coupled to each other such that the plunger is shiftable relative to the piston in order to disengage the threads of the plunger from the threads of the threaded cylinder.

10. The fluid transfer pressurizing device according to claim 9, wherein the shift of the plunger relative to the piston is brought about by at least one of the control blades.

11. The fluid transfer pressurizing device according to claim 10, wherein at least one of the control blades is provided with a lifter tip that causes the shift of the plunger.

12. It also has handles, The control button floats within the handle and follows the control blade when the control button is pressed into the handle. The fluid transfer pressurizing device according to claim 1.

13. Each of the control blades is equipped with a series of inclined fingers, The control blades are joined to each other by an interlocking function provided at the end of the inclined finger. The fluid transfer pressurizing device according to claim 1.

14. The plunger is provided with guide grooves that form a series of thrust blade control cams, At least one of the control blades comprises a series of cam drivers that ride up onto and contact the thrust blade control cam. The fluid transfer pressurizing device according to claim 1.

15. The fluid transfer pressurizing device according to claim 1, further comprising at least one locking key for securing the threaded cylinder to the syringe body.

16. The plunger has a distal end, The piston comprises a receptacle sleeve having parallel, flat side walls joined by a semicircular wall that receives the distal end of the plunger. The fluid transfer pressurizing device according to claim 1.

17. Each of the parallel, flat side walls of the receptacle sleeve is provided with a diagonally positioned receptacle slot. The fluid transfer pressurizing device according to claim 16, wherein the bottom of the receptacle sleeve is configured with a pair of inclined ramps having flat surfaces.

18. The plunger includes a distal tip, The distal tip of the plunger has a pair of flat parallel sides, Each of the flat, parallel sides is provided with an inclined retaining hook-shaped portion that engages with and holds the inclined receptacle slot of the receptacle sleeve. The fluid transfer pressurizing device according to claim 17.

19. The distal tip of the plunger has two obliquely arranged planes, one which is a contact plane and the other which is a sliding guide plane. Both the contact plane and the sliding guide plane are aligned with and engage with the inclined ramp within the receptacle sleeve. The fluid transfer pressurizing device according to claim 18.

20. The fluid transfer pressurizing device according to claim 19, wherein the two diagonally arranged planes are oriented perpendicular to the flat parallel surfaces of the distal tip of the plunger and are arranged symmetrically around the rotation axis of the plunger.

21. The fluid transfer pressurizing device according to claim 1, wherein each control blade is provided with a tab that engages with the hook of the control button.

22. The fluid transfer pressurizing device according to claim 21, wherein when the control button is pushed into the handle, the control button moves relative to the control blade which is positioned along the threads of the plunger and operates in a groove that separates the threads of the plunger.

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