Patent Publication Number: US-2020282191-A1

Title: Inflation device with self aligning crank handle

Description:
RELATED APPLICATIONS 
     The present application claims priority to U.S. Provisional Application 62/814,521, filed on Mar. 6, 2019, and titled, “Inflation Device with Self Aligning Crank Handle,” which is hereby incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to devices used to pressurize, depressurize, or otherwise displace fluid, for example in medical devices. More specifically, the present disclosure relates to high-pressure devices used to pressurize, depressurize, or otherwise displace fluid along a line in order to inflate or deflate a medical device, such as a balloon. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which: 
         FIG. 1A  is a perspective view of an inflation device assembly. 
         FIG. 1B  is a perspective view of the inflation device assembly of  FIG. 1A , shown in a partially deployed state. 
         FIG. 1C  is a perspective view of a portion of the inflation device assembly of  FIG. 1A , shown in a deployed state. 
         FIG. 2  is a perspective view of a grip of the inflation device assembly of  FIG. 1A . 
         FIG. 3  is a perspective view of a portion of the inflation device assembly of  FIG. 1A  shown in a partially deployed state. 
         FIG. 4  is a partial cutaway, partial schematic, view of a portion of the inflation device assembly of  FIG. 1A  in a partially deployed state. 
     
    
    
     DETAILED DESCRIPTION 
     An inflation device may comprise a syringe which utilizes threads to advance or retract a plunger by rotating the plunger handle relative to the body of the syringe such that the threads cause longitudinal displacement of the plunger relative to the body. In some instances, an inflation syringe may comprise retractable threads, configured to enable a practitioner to disengage the threads and displace the plunger by simply pushing or pulling the plunger. 
     The inflation syringe may comprise a coupling member configured to constrain movement of the plunger within the syringe body. The coupling member may comprise threads configured to engage with the retractable threads. Certain inflation devices include a mechanism in the handle of the device which allows the practitioner to disengage the threads through manipulating the mechanism. For example, in some instances the handle of such a device may include a “trigger” portion configured to retract threads positioned on the plunger. Actuation of the trigger may thus transition the threads between an engaged configuration where the threads are engaged with the coupling member and a released, or disengaged configuration, where the plunger is configured to be displaced with respect to the syringe body by pushing or pulling on the plunger. 
     Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated. 
     Further, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another. 
     The phrases “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component. 
     The directional terms “distal” and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest the practitioner during use. As specifically applied to the syringe portion of an inflation device, the proximal end of the syringe refers to the end nearest the handle and the distal end refers to the opposite end, the end nearest the inlet/outlet port of the syringe. Thus, if at one or more points in a procedure a physician changes the orientation of a syringe, as used herein, the term “proximal end” always refers to the handle end of the syringe (even if the distal end is temporarily closer to the physician). 
     “Fluid” is used in its broadest sense, to refer to any fluid, including both liquids and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids. 
       FIGS. 1A-4  illustrate different views of an inflation device and related components. In certain views each device may be coupled to, or shown with, additional components not included in every view. Further, in some views only selected components are illustrated, to provide detail into the relationship of the components. Some components may be shown in multiple views, but not discussed in connection with every view. Disclosure provided in connection with any figure is relevant and applicable to disclosure provided in connection with any other figure or embodiment. 
       FIGS. 1A-1C  depict an embodiment of an inflation device assembly  100 . In the illustrated embodiment, the inflation device assembly  100  comprises a syringe  110 . The inflation device assembly  100  may be described as comprising three broad groups of components; each of these groups may have multiple subcomponents and parts. The three broad component groups are: a body component such as syringe body  112 , a pressurization component such as a plunger  120 , and a handle  130 . 
     The syringe body  112  may be formed of a generally cylindrical hollow tube configured to receive the plunger  120 . The syringe body  112  may include an inlet/outlet port  115  located adjacent the distal end  114  of the syringe body  112 . In some embodiments, a coupling member  118  may be coupled to the syringe body  112  adjacent a proximal end  113  of the syringe body  112 . The coupling member  118  may include a center aperture configured to allow the plunger  120  to pass through the coupling member  118  into the syringe body  112 . Further, the coupling member  118  may include coupling member threads configured to selectively couple the coupling member  118  to the plunger  120 . In some embodiments, the coupling member  118  comprises a polymeric nut at the proximal end  113  of the syringe body  112 . 
     The plunger  120  may be configured to be longitudinally displaceable within the syringe body  112 . The plunger  120  may be comprised of a plunger shaft coupled to a plunger seal at the distal end of the plunger shaft. The plunger shaft may also be coupled to the handle  130  at the proximal end of the plunger shaft, with the plunger shaft spanning the distance between the plunger seal and the handle  130 . 
     The handle  130  broadly refers to the group of components coupled to the proximal end of the plunger  120 , some of which may be configured to be graspable by a user. In certain embodiments, the handle  130  may be configured such that the user may manipulate the position of the plunger  120  by manipulating the handle  130 . Further, in some embodiments, the handle  130  may be an actuator mechanism configured to manipulate components of the inflation device  100 . 
     The components disclosed in connection with any of the exemplary handle configurations herein may be optional. That is, though the handle  130  broadly refers to the components coupled to the proximal end of the plunger shaft which may be configured to be graspable by a user, use of the term “handle” is not meant to indicate that every handle component present in every embodiment within the scope of this disclosure. Rather, the term is used broadly, referring to the collection of components, but not specifically referring to or requiring the inclusion of any particular component, such as the crank member  132 . Likewise, other broad groupings of components disclosed herein, such as the syringe  110  or syringe body  112  and the plunger  120 , may also refer to collections of individual subcomponents. Use of these terms is also non-limiting, as each subcomponent may or may not be present in every embodiment. 
     Furthermore, the inflation device assembly  100  described herein may be configured for use with a crank handle, such as crank member  132 . The inflation device assembly  100  may be configured for use both with the crank member  132  deployed or with the crank member  132  in an undeployed state. In other words, systems within the scope of this disclosure may be configured to displace a plunger (through direct longitudinal displacement or through rotation of threads) with the crank member  132  undeployed. Thus, the system may be configured such that a practitioner has the option of deploying the crank member  132 , or utilizing the system in a manner similar to conventional systems, with the crank member  132  undeployed. 
     As shown in  FIGS. 1A-1B , a fluid reservoir  116  may be defined by the space enclosed by the inside walls of the syringe body  112  between the plunger seal and the distal end  114  of the syringe body  112 . Accordingly, movement of the plunger seal with respect to the syringe body  112  alters the size and volume of the fluid reservoir  116 . 
     As shown in  FIGS. 1A-1C , in some embodiments, the syringe  110  may comprise a coupling member  118 , fixedly coupled to the proximal end  113  of the syringe body  112 . The coupling member  118  may utilize threads or other coupling mechanisms to fixedly couple the coupling member  118  to corresponding threads on the syringe body  112 . Additionally, the coupling member  118  may be configured to engage external plunger threads  125  configured to couple the plunger  120  to the coupling member  118 . When the plunger threads  125  and the coupling member  118  are engaged, the plunger  120  may be translated longitudinally with respect to the syringe body  112  by rotating the plunger  120  such that the interaction of the coupling member threads on the inside diameter of the coupling member and the plunger threads  125  results in the longitudinal translation of the plunger  120 . Such rotating motion may be achieved when a practitioner grasps and rotates the handle  130 . In some embodiments, clockwise rotation may be configured to extend the plunger  120  distally and counter-clockwise rotation may be configured to retract the plunger  120  proximally. Other embodiments may be configured with reverse threads configured to displace the plunger distally when rotated counterclockwise and proximally when rotated clockwise. 
     Thus, when the plunger threads  125  and the coupling member threads are engaged, movement of the plunger  120  is constrained with respect to the syringe body  112 , though the plunger  120  is not necessarily fixed with respect to the syringe body  112 . For example, the plunger  120  may be rotatable, but not directly translatable, when the threads are engaged. 
     The plunger threads  125  may be configured such that they may be retracted within the plunger shaft. In some embodiments, the plunger threads  125  do not extend 360 degrees around the axis of the plunger shaft. For example, the plunger threads  125  may be formed on a thread rail  124  on the plunger shaft. The thread rail  124  may be retracted from the threads of the coupling member  118  by actuating a mechanism such as a trigger  131 . 
     The retractable threads may allow a practitioner to displace the plunger  120  relative to the syringe body  112  either through rotation of the plunger  120  (and the subsequent interaction of threads), or by retracting the plunger threads  125  and displacing the plunger  120  by applying opposing forces on the plunger  120  and the syringe body  112 . (The forces may move the plunger  120  distally or proximally with respect to the syringe body  112 .) Both methods of displacement may be utilized during the course of a single therapy. 
     In some instances, a practitioner may desire to quickly displace the plunger  120 , for instance, while priming the inflation device or while priming or deflating an attached medical device, such as a balloon. Quick displacement of the plunger  120  may be accomplished by retracting the plunger threads  125  and sliding the plunger  120  relative to the syringe body  112 . For example, a practitioner may quickly fill the fluid reservoir  116  with fluid by disengaging the plunger threads  125  and pulling the plunger  120  in a proximal direction with respect to the syringe body  112 . Further, a practitioner may quickly force fluid into lines leading to a medical device or quickly expel unwanted air bubbles from the fluid reservoir  116  by retracting the plunger threads  125  and repositioning the plunger  120 . 
     In other instances, the practitioner may desire more precise control over the position of the plunger  120  (for example when displacing the plunger  120  in order to adjust the fluid pressure within the fluid reservoir  116 ) or it may simply be difficult to displace the plunger  120  due to high fluid pressure within the fluid reservoir  116 . In these instances, the practitioner may opt to displace the plunger  120  by rotation of the plunger  120 . 
     When a practitioner rotates the handle  130  the plunger  120  may be advanced distally or retracted proximally through the threaded engagement of the thread rail  124  and the coupling member  118 . At high pressures, it can be difficult to rotate the handle  130  in order to increase the corresponding pressure in the medical device. In the embodiment depicted in  FIGS. 1A-1C , the handle  130  comprises a crank member  132  that is extendable from the handle  130 , for example, in a cantilevered fashion. The crank member  132  may further comprise a grip  134  for grasping by the practitioner&#39;s hand or fingers. The grip  134 , in turn, may be hingedly coupled to the crank member  132 . Rotation of the handle  130  using the crank member  132  when positioned in an extended or deployed position may thus generate additional mechanical advantage due to the offset of the grip  134  from the axis of rotation (the axis of the plunger shaft) which provides leverage to further advance the plunger  120  at high internal pressures. 
     Referring to  FIGS. 1A-1C :  FIG. 1A  shows the inflation device assembly prior to deployment of the crank member  132  with the crank member  132  in axial alignment with the handle  130 ;  FIG. 1B  shows the inflation device assembly  100  with the crank member  132  in a partially deployed state such that the crank member  132  extends laterally from the handle  130  and the grip  134  is nested within a cavity or channel of the crank member  132 ;  FIG. 1C  shows a portion of the inflation device assembly  100  with the crank member  132  fully deployed such that the crank member  132  extends laterally from the handle  130  and the grip  134  is elevated to a vertical orientation. 
     The crank member  132  and grip  134  can be disposed in a deployed state for use as depicted in  FIG. 1C  and an undeployed state nested within the handle  130  as depicted in  FIG. 1A . In other words, the crank member  132  may be nested within the handle  130  and may comprise an integrated part of the handle  130 . The crank member  132  may comprise a top portion  136  of the handle  130  that is hingedly coupled to a bottom portion  138  of the handle  130 . The crank member  132  may be rotatable about a first hinge  140  in order to transition the crank member  132  from an undeployed state to a deployed state. When in the deployed state, the crank member  132  may extend in a direction substantially perpendicular to the longitudinal axis of the syringe  110  and plunger  120 . The grip  134  may also be rotatable about a second hinge  142 . When deployed, the grip  134  may extend in a direction substantially parallel to (but radially offset from) the longitudinal axis of the syringe  110  and plunger  120 . 
     In the undeployed state, the grip  134  may be disposed within a channel or cavity of the crank member  132 , which, in turn, functions as the top portion  136  of the handle  130 . Thus, the grip  134  may be nested or disposed within the handle  130  and may be concealed within the handle  130 . The practitioner may selectively advance or retract the plunger  120  using the handle  130  when the crank member  132  is in the undeployed state (similar to conventional systems) or when the crank member  132  is in the deployed state utilizing the additional mechanical advantage generated by the crank member  132 . 
     The crank member  132  may thus be configured to provide additional leverage in advancing the plunger  120  to achieve elevated pressures with the inflation device assembly  100 , while also permitting disengagement of the thread rail  124  from the coupling member  118  to rapidly move the plunger  120  longitudinally within the syringe body  112 . For example, once high inflation pressures are achieved in the inflation device  100  using the crank member  132 , deflation of the balloon can be achieved rapidly through actuating the trigger  131  to disengage the thread rail  124  and not requiring a cranking motion to retract the plunger  120 . Furthermore, the grip  134  may be configured to provide an ergonomic interface with the crank member  132  for the practitioner to facilitate rotation of the handle  130 . 
     As illustrated in  FIG. 2 , the grip  134  may be a rhomboid shape in cross-section. As also noted above, the grip  134  may be configured to be nested in the cavity or channel of the crank member  132  prior to deployment of the crank member  132 . The grip  134  may include a cross-sectional first width D 1  that is larger than a cross-sectional second width D 2 . The first width D 1  may be about 25% to about 100% larger than the second width, D 2 , including about 30% to about 70% larger, and about 50%. In some embodiments, the grip  134  may comprise longitudinal first ribs  141 , second ribs  143 , and/or recesses  144  which may be configured to facilitate its gripability. In the illustrated embodiment, the first ribs  141  are aligned with the first width D 1  and the second ribs  143  are aligned with the second width D 2 . In other embodiments, the grip  134  may comprise other grip enhancing features such as bumps, texturing, soft material covering, etc. The grip  134  may be configured to axially rotate relative to the crank member  132  as the crank member  132  is rotated by the practitioner such that the practitioner does not ungrasp and re-grasp the grip  134  as the crank member  132  is rotated. 
     The grip  134  may be configured to be rotationally self-orienting such that the grip  134  self-orients to a low profile orientation when the crank member  132  is displaced from the deployed state to the undeployed state. Such alignment may be configured to allow the handle  130  to maintain a low profile when the crank member  132  is disposed in the undeployed state as shown in  FIG. 1A .  FIG. 1B  illustrates the grip  134  nested in the cavity of the crank member  132  in the low profile orientation. In the low profile orientation, the first width D 1  of the grip  134  is oriented horizontally and the second width D 2  is oriented vertically. 
       FIG. 4  illustrates the grip  134  in a partially deployed state. When the grip is displaced from the deployed state to the undeployed state, the first rib  141  of the grip  134  may be configured to engage with internal walls of the cavity or channel of the crank member  132  to rotationally self-orient the grip  134  to the low profile orientation. If the first rib  141  is not aligned with a longitudinal axis of the crank member  132  as it is displaced, it may be rotationally deflected by a bottom wall of the cavity as illustrated in  FIG. 4  as a rotational force vector is directed to the first rib  141 . The rotational deflection of the first rib  141  may continue until the grip  134  is disposed in the low profile orientation and the crank member  132  is in the undeployed state. The rotational deflection may be directed to either side of the cavity of the crank member  132 . 
     As shown in  FIGS. 1C, 3 and 4 , the crank member  132  may include a deflecting rib  145  disposed adjacent the second hinge  142 . The deflecting rib  145  may extend longitudinally within the cavity or channel of the crank member  132  and may be offset from a longitudinal axis of the crank member  132 . The deflecting rib  145  may have a triangular shape. When the grip  134  is displaced from the deployed state to the undeployed state, the deflecting rib  145  may be configured to engage with a proximal end of a first rib  141  if the first rib  141  is axially aligned with the longitudinal axis of the crank member  132 . This axial alignment may prevent the grip  134  from self-orienting to a low profile orientation in embodiments without the deflecting rib  145  due to a lack of the rotational force vector. When engaged, the deflecting rib  145  may be configured to apply a rotational force vector causing rotational deflection of the first rib  141  such that the first rib  141  rotates from the axially aligned orientation to a non-axially aligned orientation as depicted in  FIG. 4 . This allows the grip  134  to rotate to the low profile orientation as the crank member  132  is disposed to the undeployed state. 
     As depicted in  FIGS. 1B, 1C, and 4 , the bottom portion  138  of the handle  130  may comprise an axial load depression  146  configured to axially load the grip  134  when the crank member  132  is disposed from the deployed state to the undeployed state. The axial load depression  146  may be cup-shaped and configured to engage with a distal end of the first and second ribs  141 ,  143 . This engagement results in the grip  134  being axially loaded such that an axial load is exerted on the second hinge  142 . In other embodiments that do not include the axial load depression  146 , a grip may be laterally loaded as a crank member is disposed from a deployed state to an undeployed state. This lateral loading may exert a sheer load on a second hinge that couples the grip to the crank member resulting in breakage of the second hinge, in some instances. 
     In use the inflation devices and systems described above may be pressurized using any of the following steps or actions, each of which may be optional or interchanged. An inflation device is obtained which comprises a syringe body, a plunger within the syringe body, a handle coupled to the plunger (such as through a thread rail coupled to a coupling member) and a crank member coupled to the handle. The crank member may be deployed from a nested position in the handle prior to rotation of the crank member. 
     The plunger may be advanced by grasping the syringe body in one hand, and grasping a grip and rotating the crank member with the other hand. Before rotation of the crank member, the thread rail of the plunger may be disengaged from the syringe body (or coupling member). The plunger may be advanced through longitudinal movement of the handle to a first internal pressure. Then the thread rail may be re-engaged to the syringe body after reaching the first internal pressure. The plunger may be further advanced through rotational movement of the handle via the crank member to achieve a second pressure. After the therapy is complete or when desirous of depressurizing the syringe, the thread rail can be disengaged from the syringe body and retracted through longitudinal movement of the handle. 
     The crank member may be undeployed by folding the grip into the crank member. The grip may self-orient to a low profile orientation when folded. The grip may also be loaded at a distal end when engaging with the handle and exert an axial load on a hinge. 
     Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. 
     References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular configuration. 
     Similarly, in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. 
     The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description. 
     Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.