Patent Publication Number: US-2022211991-A1

Title: Arteriotomy positioning device and method of use therefor

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/558,462, filed Sep. 14, 2017, which is incorporated herein by reference in its entirety. 
    
    
     FIELD 
     Arteriotomy positioning devices described herein may be useful when performing diagnostic or therapeutic procedures requiring vascular access. The devices may be used to position an expandable support relative to an arteriotomy in a blood vessel. 
     BACKGROUND 
     Some diagnostic or therapeutic procedures require access to a patient&#39;s vasculature (e.g., imaging procedure, angioplasty, stent delivery, or otherwise). To access the patient&#39;s vasculature percutaneously, a hollow needle may be inserted through a patient&#39;s skin and overlying tissue into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer sheath may then be advanced over the guide wire into the vessel in conjunction with or subsequent to one or more dilators. A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. 
     After completion of the diagnostic or therapeutic procedure requiring access to the vasculature, the arteriotomy can be closed by various mechanical or biological solutions, such as by applying external pressure (e.g., manually and/or using sandbags), cinching, suturing, and/or delivering metal implants, plugs, or sealants. However, many of these closure procedures may be time consuming, expensive, and uncomfortable for the patient, requiring the patient to remain immobilized in the operating room, catheter lab, or holding area for long periods of time. Additionally, some of these prolonged closure procedures may increase the risk of hematoma from bleeding prior to hemostasis. 
     When closing the arteriotomy using a metal implant, plug, sealant, or other appropriate sealing member, the health care professional may use a vascular closure device to position and deploy the sealing member. The vascular closure device may include a balloon near the distal end of the device to aid in positioning the sealant relative to the arteriotomy. The balloon is not inflated when the device is provided. The distal end of the device is inserted into the puncture until the uninflated balloon is positioned in the vessel. The balloon is then inflated, and the user can verify inflation by many methods, one including viewing an inflation indicator on a proximal end of the device. The device can then be positioned by withdrawing the device proximally until the inflated balloon contacts the vessel wall around the arteriotomy, indicating that the sealant is in the correct position. Such an indication is often provided by tactile feedback. Once the balloon contacts the vessel wall, the health care professional may continue pulling back on the device while the balloon remains inflated to apply a proximal force to the vessel wall. In existing devices, applying a proximal force to the vessel wall does not substantially change the shape of the balloon. 
     SUMMARY 
     Arteriotomy positioning devices described herein may be used to position a sealing member adjacent to an arteriotomy. The arteriotomy positioning device may have a handle, a catheter assembly, a core wire, and an expandable member. The core wire may be substantially fixed relative to the handle, at least while the device is in the locating and/or tension states (described below). The catheter assembly may be moveable relative to the handle and the core wire. The proximal end of the expandable support may be connected to the catheter assembly, and the distal end of the expandable support may be connected to the core wire. The distance between distal end of the expandable support and a distal end of the handle may be substantially fixed, at least while the device is in the locating and/or tension states, whereas the proximal end of the expandable support may be moveable relative to the handle. The proximal end of the expandable support may be biased proximally, but moveable distally relative to the handle in response to various forces applied to the device. 
     The arteriotomy positioning device may have several states, including a resting state, a locating state, and a tension state. In the resting state, the expandable support may have a width small enough to fit through the arteriotomy. In the locating state, the expandable support may have a width large enough that t does not fit through the arteriotomy, but small enough that it can move freely through small vessels, thereby reducing the chance that the expandable support will interact with bifurcations or calcifications in the blood vessel while the user is moving the expandable support into position adjacent the arteriotomy. Finally, in the tension state, the expandable support may be wider than it is when the device is in the resting and locating states in order to occlude the arteriotomy and create temporary hemostasis. Because the width of the expandable support may vary between the locating state and the tension state, the width of the expandable support may be optimized based on the function being performed by the expandable support at a given time. The expandable support may be narrow enough when locating the device relative to the arteriotomy in order to fit through small vessels, but wide enough when tension is being applied to occlude the arteriotomy and create temporary hemostasis. 
     Another advantage of this arteriotomy positioning device is that the device status indicator can provide several indications to the user. The device status indicator can indicate if the expandable support is in a low-profile, medium-profile, or high-profile configuration. The device status indicator can also indicate if tension is being applied to the catheter assembly, and if so, if the amount of tension being applied is appropriate. The device status indicator can also indicate when the device is in the correct position relative to the arteriotomy, since the device will show that tension is being applied once the expandable member is pulled against the vessel wall. For example, if the expandable support is a balloon, the device status indicator can indicate whether the balloon is inflated, whether the device is in the correct position relative to the arteriotomy, and/or whether tension is being applied to the catheter assembly (and if so, whether the amount of tension being applied is appropriate). 
     An exemplary device for positioning an expandable support may comprise a handle; a catheter assembly having a lumen, the catheter assembly extending from the handle; a core wire extending from the handle through the lumen of the catheter assembly, the core wire having a proximal end connected to the handle and a distal end extending from a distal end of the catheter assembly; and an expandable support having a proximal end connected to a distal end of the catheter assembly and a distal end connected to the distal end of the core wire; wherein the catheter assembly is slidable relative to both the handle and the core wire. The expandable member may be moveable between a low-profile configuration, a medium-profile configuration, and a high-profile configuration. The device may further comprise a device status indicator that indicates whether the expandable support is in the low-profile configuration, the medium-profile configuration, or the high-profile configuration; and whether tension is being applied to the catheter assembly. A distance between the distal end of the handle and the distal end of the catheter assembly may increase as the expandable member moves from the low-profile configuration to the medium-profile configuration, and the distance further increases as the expandable member moves from the medium-profile configuration to the high-profile configuration. A distance between the distal end of the handle and the distal end of the core wire may remain substantially constant as the expandable member moves between the low-profile configuration, the medium-profile configuration, and the high-profile configuration. The device may further comprise a spring positioned in the handle, wherein the spring applies a proximal force to the catheter assembly relative to the handle and the core wire. The handle may comprise a fluid chamber, and an inflation port that allows communication with the fluid chamber. The lumen of the catheter assembly may communicate with the fluid chamber. The catheter assembly may comprise a catheter and a plunger. The catheter assembly may comprise a resting stop that limits proximal movement of the catheter assembly relative to the handle and the core wire. The catheter assembly may comprise a tension stop that limits proximal movement of the handle and the core wire relative to the catheter assembly. 
     An exemplary method for positioning a device adjacent to an arteriotomy of a blood vessel may comprise inserting a distal end of a device into the blood vessel, the device comprising a core wire connected to a handle, a catheter assembly slidable relative to the handle and the core wire, and an expandable support having a length, a width, a proximal end connected to the catheter assembly, and a distal end connected to the core wire, wherein the expandable support is in a low-profile configuration; increasing the width of the expandable support and decreasing the length of the expandable support, thereby moving the expandable support from the low-profile configuration to a medium-profile configuration; withdrawing the device proximally until the expandable support contacts a wall of the blood vessel adjacent to the arteriotomy; and applying tension to the catheter assembly to further increase the width and decrease the length of the expandable support and bring the expandable support to a high-profile configuration. The relative positions of the handle and the core wire may remain substantially constant during the steps of withdrawing the device proximally, and applying tension to the catheter assembly. The step of bringing the expandable support to the medium-profile configuration may cause the catheter assembly to move distally relative to the core wire. The step of applying tension to the catheter assembly may cause the core wire to move proximally relative to the catheter assembly. The device may comprise a visual indicator having an indicator feature and a series of indicator markings, and wherein the step of bringing the expandable support to the medium-profile configuration may cause the indicator feature to move relative to the series of indicator markings. The step of applying tension to the catheter assembly may cause the indicator feature to move relative to the series of indicator markings. The expandable support may comprise a balloon, and the width may be a maximum diameter of the balloon. The step of increasing the width of the expandable support and decreasing the length of the expandable support may comprise inflating the expandable support by pushing an inflation fluid through the catheter assembly and into the expandable support. The method may further comprise performing a procedure returning the device to the low-profile configuration; and withdrawing the device from the blood vessel. The procedure may be a vascular closure procedure. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1A  is a perspective view of an arteriotomy positioning device in a resting state. 
         FIG. 1B  is a cross-section view of the handle of the arteriotomy positioning device of  FIG. 1A  in a resting state, shown from the side. 
         FIG. 10  is a cross-section view of the expandable support of the arteriotomy positioning device of  FIG. 1A  in a resting state, shown from the side. 
         FIG. 2A  is a perspective view of the arteriotomy positioning device in a locating state. 
         FIG. 2B  is a cross-section view of the handle of the arteriotomy positioning device of  FIG. 2A  in a locating state, shown from the side. 
         FIG. 2C  is a cross-section view of the expandable support of the arteriotomy positioning device of  FIG. 2A  in a locating state, shown from the side. 
         FIG. 3A  is a perspective view of the arteriotomy positioning device in a tension state with too little force. 
         FIG. 3B  is a cross-section view of the handle of the arteriotomy positioning device of  FIG. 3A  in a tension state with too little force, shown from the side. 
         FIG. 3C  is a cross-section view of the expandable support of the arteriotomy positioning device of  FIG. 3A  in a tension state with too little force, shown from the side, 
         FIG. 4A  is a perspective view of the arteriotomy positioning device in a tension state with an appropriate amount of force. 
         FIG. 4B  is a cross-section view of the handle of the arteriotomy positioning device of  FIG. 4A  in a tension state with an appropriate amount of force, shown from the side. 
         FIG. 4C  is a cross-section view of the expandable support of the arteriotomy positioning device of  FIG. 4A  in a tension state with an appropriate amount of force, shown from the side. 
         FIG. 5A  is a perspective view of the arteriotomy positioning device in a tension state with too much force. 
         FIG. 5B  is a cross-section view of the handle of the arteriotomy positioning device of  FIG. 5A  in a tension state with too much force, shown from the side. 
         FIG. 5C  is a cross-section view of the expandable support of the arteriotomy positioning device of  FIG. 5A  in a tension state with too much force, shown from the side. 
         FIGS. 6-11  show a cross-section view of alternative embodiments of the handle of the arteriotomy positioning device in a resting state, shown from the side. 
         FIG. 12A  is a perspective view of an alternative embodiment for an arteriotomy positioning device in a resting state. 
         FIG. 12B  is a perspective view of the arteriotomy positioning device of  FIG. 12A  in a locating state. 
         FIG. 12C  is a perspective view of the arteriotomy positioning device of  FIG. 12A  in an expanded state. 
         FIG. 13A  is a cross-section view of a handle used with the expandable support of  FIG. 12A  in a resting state, shown from the side. 
         FIG. 13B  is a cross-section view of the handle of  FIG. 13A  used with the expandable support of  FIG. 12B  in a locating state, shown from the side. 
         FIG. 13C  is a cross-section view of the handle of  FIG. 13A  used with the expandable support of  FIG. 12C  in an expanded state, shown from the side. 
     
    
    
     Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. 
     DETAILED DESCRIPTION 
     The detailed description set forth below, in connection with the appended drawings, is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. 
     Various aspects of an arteriotomy positioning device may be illustrated by describing components that are coupled, attached; connected, pneumatically associated, and/or joined together. As used herein, the terms “coupled”, “attached”, “connected”, “pneumatically associated”, “in communication with”, and/or “joined” are interchangeably used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, “directly connected” and/or “directly joined” to another component there are no intervening elements shown in said examples. 
     An example embodiment of an arteriotomy positioning device  100  is shown in  FIGS. 1A-5C  and may include a handle  110 . A catheter assembly  120  may extend from the handle  110 . The catheter assembly  120  may include a plunger  130  and a catheter  140 . A core wire  150  may extend from the handle  110  and through a lumen  125  of the catheter assembly  120 . A spring  170  may be positioned in the handle  110 . An expandable support  160  may be located near the distal end of the device  100 , and may be connected to both the core wire  150  and the catheter assembly  120 . 
     The arteriotomy positioning device  100  may include a handle  110 , as shown in  FIGS. 1A-5B , The handle  110  may extend longitudinally between a proximal end  111  and a distal end  112 . The handle  110  may include an inner housing  110   a  and an outer housing  110   b  as shown in  FIG. 1B . In one aspect, the inner housing  110   a  and outer housing  110   b  may be molded as a single component. Features described as being included in the handle  110  could be included in one or both of the inner housing  110   a  or the outer housing  110   b . Features described as being included in the inner housing  110   a  could alternatively be included in the outer housing  110   b , and vice versa. The handle  110  may also include other components or features not shown in the figures. 
     The interior of the handle  110  may have a fluid chamber  113 . The fluid chamber  113  may be formed by the inner housing  110   a . The handle  110  may include an inflation port  114  that is in communication with the fluid chamber  113 . The fluid chamber  113  may be in communication with the interior of the expandable support  160  via a lumen  125  of the catheter assembly  120 . Therefore, a syringe or other source of inflation fluid may be coupled to the inflation port  114  to provide inflation fluid to fluid chamber  113 , such that the expandable support  160  is able to expand, as described below. The inflation fluid may be saline, air, or another fluid appropriate for inflation. A valve (not shown) may also be coupled to the inflation port  114  to selectively allow fluid to enter and exit the fluid chamber  113 . These features may be particularly useful if the expandable support is an inflatable balloon. 
     The distal end  112  of the handle  110  may also include a distal port  115  aligned along a longitudinal axis  103  of the device  100 . The distal port  115  may be in communication with the interior of the handle  110 . The catheter assembly  120  may extend through the distal port  115 , such that a proximal end of the catheter assembly  120  may be located on the interior of the handle  110 , and a distal end of the catheter assembly  120  may be located exterior to the handle  110 . 
     The interior of the handle  110  may also have a second chamber  109 , as shown in  FIG. 1B , The second chamber  109  may be an area inside the inner housing  110   a , but outside the fluid chamber  113 . The second chamber  109  may house the spring  170  and a portion of the catheter assembly  120 . As shown in  FIG. 1B , the second chamber  109  may house a portion of the plunger  130  and a portion of the catheter  140 . The second chamber  109  may be distal to the fluid chamber  113 , and they may be separated by a seal  118 . In other embodiments, the spring  170  and/or plunger  130  may be positioned either inside the fluid chamber  113 , or inside the handle  110  but outside both the fluid chamber  113  and the second chamber  109 . In still other embodiments, the second chamber may be omitted, and the spring  170  and/or plunger  130  may be located in the fluid chamber  113  and/or inside the handle  110  but outside the fluid chamber  113 . 
     The handle  110  may include a seal  118  (e.g., an o-ring) around an opening in a distal end of the fluid chamber  113 . The seal  118  may separate the fluid chamber  113  from the rest of the interior of the handle  110 . The seal  118  may have a channel  119  that allows fluid to enter and exit the fluid chamber  113 . The channel  119  in the seal  118  may be aligned along a longitudinal axis  103  of the device  100 . The seal  118  may be substantially fixed relative to the handle  110 . The handle  110  may further have proximal and/or distal seal retaining walls (similar to those shown in  FIG. 7  as  718   a  and  718   b , respectively) to prevent the seal  118  from moving within fluid chamber  113 , Alternatively, the seal  118  may be connected to the handle  110  using an adhesive, or the seal  118  may be inserted into a groove in the handle  110 , or it can be held in place relative to the handle  110  by any other appropriate mechanism. 
     The arteriotomy positioning device  100  may further include a core wire  150 , The core wire  150  may be an elongate member having a proximal end  151  and a distal end  152 . The core wire  150  is shown as being solid in all embodiments; however, any of the embodiments could alternatively use a core wire with one or more lumens. 
     The core wire  150 , and preferably the proximal end  151  of the core wire  150 , may be connected to the handle  110 . Movement of the handle  110  may also move the core wire  150 , at least when the device  100  is in the locating and tension states as described below. In the embodiment of  FIG. 1A , the core wire  150  is connected to the inner housing  110   a , and more precisely, the proximal end  151  of the core wire  150  is connected to the proximal end of the fluid chamber  113 . The core wire  150  may extend substantially along the longitudinal axis  103  of the device  100 , The core wire  150  may extend through at least one, and preferably both, of the channel  119  in the seal  118  and the distal port  115  of the handle  110 . 
     The arteriotomy positioning device  100  may further include a catheter  140 . The catheter  140  may be an elongate tubular member having a proximal end  141  and a distal end  142 , A lumen  145  may extend from the proximal end  141  to the distal end  142 . Thus, the catheter  140  may have an outer surface  143  and an inner surface  144 . 
     The arteriotomy positioning device  100  may further include a plunger  130 . The plunger  130  may have a proximal end  131  and a distal end  132 . The plunger  130  may have a lumen  135 , which may extend from the proximal end  131  to the distal end  132 . Thus, the plunger  130  may have an outer surface  133  and an inner surface  134 . 
     The catheter  140  may be connected to the plunger  130  to form a catheter assembly  120 . The position of the catheter  140  relative to the plunger  130  may be substantially fixed, such that the catheter  140  moves together with the plunger  130 , i.e., the catheter  140  is moveable upon movement of the plunger  130 . The catheter  140  may be inserted into the lumen  135  of the plunger  130 , such that the outer surface  143  of the catheter  140  may be in contact with, and preferably connected to, the inner surface  134  of the plunger  130 . 
     The catheter assembly  120  may have a lumen  125 . The lumen  125  may be formed by one or more of the lumen  145  of the catheter  140  and the lumen  135  of the plunger  130 . As shown in  FIGS. 1B-5B , the catheter  140  may extend along the entire lumen  135  of the plunger  130 , such that the lumen  125  of the catheter assembly  120  is the lumen  145  of the catheter  140 . Alternatively, the catheter  140  may extend along part of the lumen  135  of the plunger  130 , such that the lumen  125  of the catheter assembly  120  is formed by both the lumen  145  of the catheter  140  and the lumen  135  of the plunger  130 . 
     The catheter assembly  120  may have a proximal end  121  and a distal end  122 . Preferably, the distal end  142  of the catheter  140  forms the distal end  122  of the catheter assembly  120 . The proximal end  141  of the catheter  140 , the proximal end  131  of the plunger  130 , or both may form the proximal end  121  of the catheter assembly  120 . 
     In other embodiments, the plunger  130  and the catheter  140  may be formed as a single part. In still other embodiments, the plunger  130  and the catheter  140  may be separate parts connected to one another using an adhesive, interference fit, or any other appropriate attachment mechanism known in the art. In some embodiments, features described as being included on the plunger  130  (including, but not limited, to the tension stop  126 , resting stop  127 , and/or various features of the device status indicator  104  (to be discussed below) may alternatively be included on the catheter  140 . 
     The catheter assembly  120  may extend along the longitudinal axis  103  of the device  100 , and may be positioned partially inside the handle  110 . The proximal end  121  of the catheter assembly  120  may be positioned inside the handle  110 , and preferably inside the fluid chamber  113 . The lumen  125  of the catheter assembly  120  may be in communication with the fluid chamber  113  and inflation port  114  of the handle  110 . The core wire  150  may extend through the lumen  125  of the catheter assembly  120 . The distal end  152  of the core wire  150  may be distal to the distal end  122  of the catheter assembly  120 . 
     The catheter assembly  120  may slidably extend through one or both of the channel  119  in the seal  118  and the distal port  115  of the handle  110 . The catheter assembly  120  may sealingly engage the seal  118  of the handle  110 , such that fluid leaving the fluid chamber  113  through the channel  119  in the seal  118  will flow through the lumen  125  of the catheter assembly  120 . If the plunger  130  extends through the seal  118 , as shown in  FIGS. 1B-5B , the plunger  130  may form a seal with the seal  118  of the handle  110 . Alternatively, if the proximal and distal ends  131 ,  132  of the plunger  130  are both either inside the fluid chamber  113  or outside the fluid chamber  113  (as shown in  FIG. 6 ), then the catheter  140  may extend through and form a seal with the seal  118  of the handle  110 . Therefore, when the catheter assembly  120  engages the seal  118  of the handle  110 , fluid may enter and/or exit the fluid chamber  113  through the lumen  125  of the catheter assembly  120  and the inflation port  114  of the handle  110 . 
     The device  100  may include two sets of stops: a resting stop and a tension stop. As the catheter assembly  120  moves proximally relative to the handle  110  and core wire  150 , a resting stop  127  on the catheter assembly  120  may contact a corresponding resting stop  117  of the handle  110 , thereby preventing further proximal movement of the catheter assembly  120 . As the handle  110  and core wire  150  move proximally relative to the catheter assembly  120 , a tension stop  126  on the catheter assembly  120  may contact a corresponding tension stop  116  of the handle  110 , thereby preventing further proximal movement of the handle  110  and core wire  150 . 
     In the embodiment of  FIGS. 1B and 5B , the resting stop  117  of the handle  110  may be a distal surface of seal  118  (or a distal seal retaining wall, not shown), and the tension stop  116  of the handle  110  may be a proximal surface of the seal  118  (or a proximal seal retaining wall, not shown). Alternatively, the tension and resting stops of the handle  110  may be formed by other walls and/or features of the handle  110  based on the configuration of the handle  110  and the catheter assembly  120 . For example, the proximal wall of the fluid chamber  113  may form a resting stop. A distal wall of the fluid chamber  113 , or a wall at the distal end  112  of the handle  110 , may form a tension stop. Various other features not shown in the figures may also be included in the handle to act as tension and resting stops. 
     The tension and resting stops  126 ,  127  on the catheter assembly  120  may preferably be included in the plunger  130 . The stops  126 ,  127  may be projections extending from the outer surface  133  of the plunger  130 , as shown in  FIGS. 1B and 5B . Alternatively, the proximal end  121  of the catheter assembly  120  may form the resting stop, and/or the distal end  132  of the plunger  130  may form the tension stop. Based on the configuration of the handle  110  and the catheter assembly  120 , various other features not shown in the figures may also be included in the catheter assembly to act as tension and resting stops. 
     The catheter assembly  120  may be positioned such that the tension stop  126  and the resting stop  127  of the catheter assembly  120  are inside the handle  110 , although their positions within the handle  110  depend on the configuration of the catheter assembly  120  and the handle  110 . In the embodiment shown in  FIGS. 1B-5B , the tension stop  126  may be positioned inside the fluid chamber  113  of the handle  110 . The resting stop  127  may be positioned outside the fluid chamber  113  but inside the handle  110 , and as shown in  FIGS. 1B-5B , the resting stop  127  may be positioned inside the second chamber  109 ). Alternatively, the resting stop may be positioned inside the fluid chamber  113  of the handle  110 , while the tension stop may be positioned outside the fluid chamber  113  but inside the handle  110 . The tension stop and the resting stop may also both be inside the fluid chamber  113  of the handle  110  (as shown in  FIG. 7 ), or may both be outside the fluid chamber  113  but inside the handle  110  (not shown). 
     In the embodiment shown in  FIG. 1B , the resting stops  117 ,  127  on the handle  110  and catheter assembly  120  are positioned distally relative to their respective tension stops  116 ,  126 . Depending on the configuration of the plunger  130  and handle  110 , the resting stops on the handle  110  and catheter assembly  120  may alternatively be positioned proximally relative to their respective tension stops on the handle  110  and catheter assembly  120 . 
     The catheter assembly  120  may be moveable relative to the handle  110  and the core wire  150 . Preferably, the catheter assembly  120  is slidable relative to the handle  110  and the core wire  150  along a longitudinal axis  103  of the device  100 . The catheter assembly  120  may be able to slide through one or both of the channel  119  in the seal  118  or the distal port  115  of the handle  110 . 
     The arteriotomy positioning device  100  may further include an expandable support  160 . The expandable support  160  may be a balloon, a group of splines, a combination thereof, or any expandable structure that can move between a low-profile configuration, a medium-profile configuration, and a high-profile configuration. The expandable support  160  may have a proximal bonding region  161  at its proximal end and a distal bonding region  162  at its distal end. The axial length (also referred to as the length) of the expandable support  160  may be the distance between the proximal bonding region  161  and the distal bonding region  162 , as measured along the longitudinal axis  103  of the device  100 . A width of the expandable support  160  may be measured substantially perpendicularly to the longitudinal axis  103  of the device  100 , at the widest part of the expandable support  160 . If the expandable support  160  is a balloon, the balloon may be provided in standard shapes and sizes, and may be made from conventional materials. If the expandable support is in the shape of a sphere or ellipsoid, the width would be the maximum diameter of the expandable support  160  in a direction substantially perpendicularly to the longitudinal axis  103  of the device  100 . As will be described below, the length and the width of the expandable support  160  may change as the expandable support  160  is moved between the low-profile configuration, the medium-profile configuration, and the high-profile configuration. 
     The expandable support  160  may be connected to the catheter  140  and the core wire  150 . The proximal bonding region  161  of the expandable support may be connected to the distal end  122  of the catheter assembly  120 . More specifically, the proximal bonding region  161  of the expandable support  160  may be connected to the distal end  142  of the catheter  140 . Therefore, the proximal bonding region  161  of the expandable support  160  may be substantially fixed relative to the catheter assembly  120 , but may be moveable relative to the core wire  150  and handle  110 . The distal bonding region  162  of the expandable support  160  may be connected to the distal end  152  of the core wire  150 . Therefore, the distal bonding region  162  of the expandable support  160  may be substantially fixed relative to the core wire  150  and handle  110 , but moveable relative to the catheter assembly  120 . If the expandable support  160  is a balloon, the lumen  145  of the catheter  140  may communicate with the interior of the balloon. Therefore, the interior of the balloon may be in communication with the inflation port  114  via the lumen  125  of the catheter assembly  120  and the fluid chamber  113  of the handle  110 . 
     The length of the expandable support  160  may change if the catheter assembly  120  is moved relative to the core wire  150 , allowing the expandable support  160  to move between the low-profile configuration, the medium-profile configuration, and the high-profile configuration. In the low-profile configuration, the expandable support  160  may have a first length  164   a  and a first width  163   a  as shown in  FIG. 1C . In the medium-profile configuration, the expandable support  160  may have a second length  164   b  and a second width  163   b  as shown in  FIG. 2C . In the high-profile configuration, the expandable support  160  may have a third length  164   c   1 ,  164   c   2 , or  164   c   3  and a third width  163   c   1 ,  163   c   2 , or  163   c   3  as shown in  FIGS. 3C, 4C, and 5C , respectively. Generally, the length may decrease and the width may increase as the expandable support  160  moves from the low-profile configuration to the medium-profile configuration to the high-profile configuration. The first length  164   a  may be longer than the second length  164   b , both of which may be longer than the third lengths  164   c   1 ,  164   c   2  and  164   c   3 . The first width  163   a  may be smaller than the second width  163   b , both of which may be smaller than the third width  163   c   1 ,  163   c   2 , and  163   c   3 . 
     For simplicity, the first width  163   a , first length  164   a , second width  163   b , second length  164   b , third width  163   c   1 ,  163   c   2 , and  163   c   3 , and third length  164   c   1 ,  164   c   2  and  164   c   3  are each referred to as a “width” or a “length”, but each width may encompass a range of widths and each length may encompass a range of lengths. For example,  FIGS. 30, 4C, and 50  show that the third width may include widths  163   c   1 ,  163   c   2 , and  163   c   3  (listed from narrowest to widest), and the third length may include lengths  164   c   1 ,  164   c   2 , and  164   c   3  (listed from longest to shortest). Each of widths  163   c   1 ,  163   c   2 , and  163   c   3  may be wider than any first width  163   a  and second width  163   b , and each of lengths  164   c   1 ,  164   c   2  and  164   c   3  may be shorter than any first length  164   a  or second length  164   b.    
     The arteriotomy positioning device  100  may also include a spring  170 . The spring  170  may apply a proximal force to the catheter assembly  120  to bias the catheter assembly  120  proximally relative to the handle  110  and the core wire  150 , and similarly, to bias the handle  110  and the core wire  150  distally relative to the catheter assembly  120 . The spring  170  may be positioned inside the handle  110 , and may be outside the fluid chamber  113  (as shown in  FIG. 1B ), or, alternatively, inside the fluid chamber  113  (as shown in  FIG. 7 ). The spring  170  may extend between a spring-contacting surface of the handle  110  and a spring-contacting surface of the catheter assembly  120 . The locations of the spring-contacting surfaces may vary based on the configuration of the handle  110  and catheter assembly  120 . Preferably, if spring  170  is a compression spring, the spring-contacting surface of the handle  110  may be distal to a spring-contacting surface of the catheter assembly  120 . The spring-contacting surfaces may be a proximal-facing surface of the handle  110  and a distal-facing surface of the catheter assembly  120 . For example, in the embodiment shown in  FIG. 1B , the spring-contacting surfaces are a distal wall of the inner housing  110   a  and the resting stop  127  of the catheter assembly  120 . However, various features of the handle  110  and the catheter assembly  120  may serve as spring-contacting surfaces. 
     The device  100  may be designed to prevent the user from unintentionally pulling the expandable support  160  through the blood vessel  001  when applying tension to the catheter assembly  120 . The force required to compress the spring  170  and move the housing  110  and core wire  150  proximally relative to the catheter assembly  120  when applying tension to the catheter assembly  120  may preferably be less than the force required to pull the expandable support  160  through the blood vessel  001 . The force required to pull the expandable support  160  through the blood vessel  001  may increase as the width  163  of the expandable support  160  increases. For example, the force to pull the expandable support  160  through the arteriotomy when the expandable support  160  is in the high-profile configuration may be higher than the force to pull the expandable support  160  through the arteriotomy when the expandable support is in the medium-profile configuration. Therefore, increasing the tension applied to the catheter assembly  120  may also increase the force required to pull the expandable support  160  through the blood vessel  001 , allowing the user to apply an increasing amount of force without pulling the expandable support  160  through the vessel. 
     During use, the arteriotomy positioning device  100  may be moveable between at least three states: a resting state, a locating state, and a tension state. 
     When the arteriotomy positioning device  100  is in the resting state (see  FIGS. 1A-1C ), the expandable support  160  may be in the low-profile configuration, having a resting width (or first width)  163   a  and a resting length (or first length)  164   a . The spring  170  may bias the catheter assembly  120  proximally to its proximal-most position relative to the core wire  150  and handle  110 , thereby pulling the proximal end  161  of the expandable support  160  proximally which minimizes the resting width  163  of the expandable support  160 . The resting stop  127  of the catheter assembly  120  may rest on the resting stop  117  of the handle  110 . Therefore, when the device  100  is in the resting state, the resting stop  127  may prevent the catheter assembly  120  from moving proximally relative to the handle  110  and the core wire  150 , and the spring  170  may resist distal movement of the catheter assembly  120  relative to the handle  110  and the core wire  150 . 
     The device may include a releasable resting lock to maintain the expandable support  160  in the resting state. When engaged, the resting lock may prevent the catheter assembly  120  from moving distally relative to the handle  110  and the core wire  150 , thereby preventing the expandable support  160  from moving from the low-profile configuration to the medium-profile configuration or high-profile configuration. When the resting lock is disengaged, the catheter assembly  120  may be able to move distally relative to the handle  110  and the core wire  150 , allowing the expandable support  160  to move from the low-profile configuration to the medium-profile configuration or high-profile configuration. The user may be able to selectively engage and disengage the resting lock. 
     If the expandable support  160  is a balloon, the resting lock may be a valve associated with the inflation port  114 . The resting lock may be engaged by closing the valve, thereby preventing inflation fluid from entering the fluid chamber  113  through the inflation port  114 . The resting lock may be disengaged by opening the valve, thereby allowing inflation fluid to enter the fluid chamber  113  through the inflation port. 
     When the arteriotomy positioning device  100  is in the locating state (see  FIGS. 2A-2C ), the expandable support  160  may be in the medium-profile configuration, having a locating width (or second width)  163   b  and a locating length (or second length)  164   b . The locating width  163   b  may be larger than the resting width  163   a . The locating length  164   b  may be shorter than the resting length  164   a . In the locating state, the catheter assembly  120  may be positioned distally relative to the core wire  150  and handle  110 , as compared to their respective positions in the resting state. The distance between the distal end  122  of the catheter assembly  120  and the distal end  112  of the handle  110  may be increased in the locating state compared to the resting state. The distance between the distal end  122  of the catheter assembly  120  and the distal end  152  of the core wire  150  may be decreased in the locating state compared to the resting state. The distance between the distal end  152  of the core wire  150  and the distal end  112  of the handle  110  may be substantially constant between the resting state and locating state. The resting stop  127  of the catheter assembly  120  may be spaced from the resting stop  117  of the handle  110 . The spring  170  may be more compressed in the locating state compared to the resting state. Therefore, the spring  170  may still resist distal movement of the catheter assembly  120  relative to the handle  110  and the core wire  150 . If the expandable support  160  is a balloon, the balloon may be inflated when the device is in the locating state. 
     The device may include a releasable locating lock to prevent the device  100  from unintentionally moving from the locating state (or the tension state) back to the resting state. When engaged, the locating lock may limit proximal movement of the catheter assembly  120  relative to the handle  110  and the core wire  150  such that the expandable support  160  can move between the medium-profile configuration and high-profile configuration, but it cannot move to the low-profile configuration. When the locating lock is disengaged, the expandable support  160  may be able to move between the medium-profile configuration (or the high-profile configuration) and the low-profile configuration. The user may be able to selectively engage and disengage the locating lock. 
     If the expandable support  160  is a balloon, the locating lock may be a valve (not shown) associated with the inflation port  114 . The same valve may act as the resting lock and the locating lock. The locating lock may be engaged by closing the valve after inflation fluid has entered the fluid chamber  113 , thereby preventing fluid from exiting the fluid chamber  113  through the inflation port  114 . The locating lock may be disengaged by opening the valve, thereby allowing inflation fluid to exit the fluid chamber  113  through the inflation port  114 . 
     When the arteriotomy positioning device  100  is in the tension state (see  FIGS. 3A-50 ), the expandable support  160  may be in the high-profile configuration, having a tension width (or third width)  163   c   1 ,  163   c   2 , and  163   c   3  and a tension length (or third length)  164   c   1 ,  164   c   2 , and  164   c   3 . The tension width  163   c   1 ,  163   c   2 , and  163   c   3  may be larger than both the resting width  163   a  and the locating width  163   b . The tension length  164   c   1 ,  164   c   2 , and  164   c   3  may be shorter than both the resting length  164   a  and the locating length  164   b . In the tension state, the core wire  150  and handle  110  may be positioned proximally relative to the catheter assembly  120 , as compared to their respective positions in both the resting state and the locating state. The distance between the distal end  122  of the catheter assembly  120  and the distal end  112  of the handle  110  may be increased in the tension state compared to the resting and locating states. The distance between the distal end  122  of the catheter assembly  120  and the distal end  152  of the core wire  150  may be decreased in the tension state compared to the resting and locating states. The distance between the distal end  152  of the core wire  150  and the distal end  112  of the handle  110  may be substantially constant between the resting, locating, and tension states. If the expandable support  160  is a balloon, the balloon may remain inflated when the device is in the tension state. The device may have substantially the same amount of inflation fluid in the tension state as it does in the locating state. 
       FIGS. 3C, 4C, and 5C  show that the tension width and tension length may vary while the expandable support is in the high-profile configuration. This variation may be correlated to the amount of tension applied to the catheter assembly  120 . For example, if an adequate amount of tension is applied to the catheter assembly  120 , as shown in  FIG. 4C , the expandable support may have a width  163   c   2  and length  164   c   2 . If too much tension is applied to the catheter assembly  120 , as shown in  FIG. 5C , the expandable support  160  may have a width  163   c   3  that is greater than width  163   c   2 , and a length  164   c   3  that is shorter than length  164   c   2 . If too little tension is applied to the catheter assembly  120 , as shown in  FIG. 3C , the expandable support  160  may have a width  163   c   1  that is less than width  163   c   2 , and a length  164   c   1  that is longer than length  164   c   2 . 
     When the arteriotomy positioning device  100  is in the tension state, the resting stop  127  of the catheter assembly  120  may be spaced from a resting stop  117  of the handle  110 . The tension stop  126  of the catheter assembly is not necessarily in contact with the tension stop  116  on the handle  110 . However, increasing the tension on the catheter assembly  120  to an undesirably high level may cause the tension stop  126  to contact a tension stop  116  of the handle  110 , preventing further proximal movement of the core wire  150  and handle  110  relative to the catheter assembly  120 , which limits the amount of tension on the catheter assembly  120 . The spring  170  may be more compressed in the tension state compared to the resting and locating states. Therefore, the spring  170  may still resist proximal movement of the handle  110  and the core wire  150  relative to the catheter assembly  120 , even if the tension stops  126 ,  116  on the catheter assembly and handle  110  are not in contact. 
     The arteriotomy positioning device  100  may include a device status indicator  104  which visually indicates both the status of the device  100  (i.e., whether the device is in the resting state, locating state, or tension state) and the amount of tension, if any, being applied to the catheter assembly  120 . The device status indicator  104  may allow the user to compare a feature on the catheter assembly  120  to a feature on the handle  110  to determine the longitudinal position of the catheter assembly  120  relative to the core wire  150 . 
     The device status indicator  104  may include an indicator feature  105  on one component that moves relative to a series of markings  106  (including but not limited to lines, colored bands, raised or lowered features, etc.) on another component. The device status indicator  104  may include a series of markings  106  on the handle  110  and an indicator feature  105  on the catheter assembly  120 . For example, the indicator feature  105  may be a protrusion on the plunger  130 , and the markings  106  may be on the handle  110  as shown in  FIG. 1A . Alternatively, the device status indicator may include a series of markings on the catheter assembly, and an indicator feature on the handle. For example, the indicator feature may be a window in the handle as shown in  FIG. 8 , or it could simply be the distal port of the handle as shown in  FIG. 11 . In any case, when the catheter assembly  120  slides relative to the handle  110 , the indicator feature  105  aligns with one of the markings  106  to show the status of the device  100 , and the amount of tension, if any, being applied to the catheter assembly  120 . The handle  110  may include an indicator window  107  to allow the user to visualize either a marking  106  on the catheter assembly  120  or a position of an indicator feature  105  on the catheter assembly relative to markings  106  on the handle  110  near the indicator window  107 . 
     The device status indicator  104  may include the following markings  106 : 1) a marking  106   a  indicating that the device  100  is in the resting state, the expandable support  160  is in a low-profile configuration, and the catheter assembly  120  is not under tension, 2) a marking  106   b  indicating that the device  100  is in the locating state and the expandable support  160  is in a medium-profile configuration, and the catheter assembly  120  is not under tension, and 3) one or more markings  106   c   1 ,  106   c   2 ,  106   c   3  indicating that the device  100  is in the tension state, the expandable support  160  is in a high-profile configuration, and the catheter assembly  120  is under tension. Marking  106   c   1  may indicate that the catheter assembly  120  is under tension with too little force, marking  106   c   2  may indicate that the catheter assembly  120  is under tension with appropriate force, and marking  106   c   3  may indicate that the catheter assembly  120  is under tension with too much force. If the markings  106  are included on the catheter assembly  120 , marking  106   a  may preferably be the distal-most marking, followed in order by marking  106   b , then marking  106   c   1 , then marking  106   c   2 , and finally, marking  106   c   3 , which may be the proximal-most marking. If the markings are included on the handle  110 , marking  106   a  may preferably be the proximal-most marking, followed in order by marking  106   b , then marking  106   c   1 , then marking  106   c   2 , and finally, marking  106   c   3 , which may be the distal-most marking. However, the reverse order may also be used, or the markings may be arranged in a different order depending on the configuration of the device  100  and the device status indicator  104 . One or more of markings  106   a ,  106   b ,  106   c   1 ,  106   c   2 , and  106   c   3  may be omitted, or additional markings may be included. 
     The following exemplary method (described in detail in the following paragraphs) may be used when locating an arteriotomy and performing a procedure. The method may include steps of inserting the expandable support through the arteriotomy and into the vessel, moving the device to the locating state, withdrawing the handle proximally until the expandable support contacts the arteriotomy, continuing to withdraw the handle proximally to apply tension to the catheter assembly and move the device to the tension state, performing a procedure, returning the device to its resting state, and withdrawing the device from the patient. It is understood that one or more of these steps may be omitted and other steps may be included in this method. 
     First, the user may insert the device  100  into the patient, thereby inserting the expandable support into the vessel  001  through the arteriotomy  002 , as illustrated in  FIG. 1A . During insertion, the arteriotomy positioning device  100  may be in the resting state, and the device status indicator  104  may be in a position that indicates that the device  100  is in the resting state. A resting lock may be engaged to secure the device  100  in the resting state during insertion. The expandable support  160 , the distal end  122  of the catheter assembly  120  (preferably the distal end  142  of the catheter  140 ), and the distal end  152  of the core wire  150  may be inserted into the vessel  001  through the arteriotomy  002 , as shown by the arrow in  FIG. 1A . The expandable support  160  may be in the low-profile configuration. The resting width  163   a  of the expandable support may be smaller than the width of the arteriotomy  002 , which allows the expandable support to fit through the arteriotomy  002 . The handle  110 , core wire  150 , and catheter assembly  120  may all move together during insertion, since a distal force is not being applied to the distal end  142  of the catheter  140 . When the device  100  has been inserted and the expandable support  160  is positioned in the vessel  001 , a resting lock may be disengaged, allowing the device  100  to be moved from the resting state to the locating state. 
     When the expandable support  160  is positioned inside the vessel, the user may move the arteriotomy positioning device  100  from the resting state to the locating state. The expandable support  160  may move from the low-profile configuration to the medium-profile configuration, while the catheter assembly  120  may move distally relative to the handle  110  and the core wire  150 , The width  163  of the expandable support  160  may increase from the resting width  163   a  to the locating width  163   b . The locating width  163   b  may be larger than the width of the arteriotomy  002  to prevent the expandable support from being pulled through the arteriotomy  002  while the device is in the locating state. The length  164  of the expandable support  160  may decrease from the resting length  164   a  to the locating length  164   b . The distal resting stop  127  of the catheter assembly  120  may move away from the resting stop  117  of the handle  110 , such that they are no longer in contact. The spring  170  may still resist distal movement of the catheter assembly  120  relative to the handle  110  and the core wire  150 . The spring  170  may compress when the device  100  is moved from the resting state to the locating state. The device status indicator  104  may move from a position indicating that the device  100  is in the resting state to a position indicating that the device  100  is in the locating state. Once the device  100  reaches the locating state, a locating lock may be engaged to prevent the device  100  from unintentionally reverting to the resting state during use. 
     If the expandable support  160  is a balloon, the step of moving the arteriotomy positioning device  100  from the resting state to the locating state may involve inflating the balloon. The device  100  may be moved from the resting state to the locating state by pushing the inflation fluid through the inflation port  114 , into the fluid chamber  113  of the handle  110 , through the lumen  125  of the catheter assembly  120 , and into the interior of the balloon. Once the device  100  reaches the locating state, a valve (not shown) associated with the inflation port  114  may be closed to prevent the inflation fluid from flowing out of the fluid chamber  113  through the inflation port  114 . 
     When the arteriotomy positioning device  100  is in the locating state, the user may withdraw the handle  110  proximally to move the expandable support  160  closer to the arteriotomy  002 , as shown by the arrow in  FIG. 2A . The catheter assembly  120  is not under tension at this point because no distal force is being applied to the distal end  142  of the catheter  140 . Therefore, the handle  110 , core wire  150 , and catheter assembly  120  may all move proximally together, and the device  100  may remain in the locating state until the user locates the arteriotomy  002  (in other words, until the expandable support  160  contacts the vessel  001  at the arteriotomy  002 ). The device status indicator  104  may show that a small amount of tension is being applied to the catheter assembly  120  to indicate that the expandable support  160  has contacted the vessel  001  and the device  100  is in the correct position. 
     When the expandable support  160  contacts the arteriotomy  002 , the user may continue withdrawing the handle  110  proximally (as shown by the arrows in  FIGS. 3A, 4A, and 5A ) to apply tension to the catheter assembly  120  and bring the device  100  to the tension state. When the device  100  is under tension, the catheter assembly  120  is constrained by the vessel wall  001  and remains substantially stationary. Applying a proximal force to the handle  110  causes the vessel wall  001  to apply a distal force to the expandable support  160 , and this distal force is transmitted to the distal end  122  of the catheter assembly  120  (and preferably to the distal end  142  of the catheter  140 ). Meanwhile, the user applies a proximal force to the handle  110 , which compresses the spring  170  and transmits the proximal force to the proximal end  121  of the catheter assembly  120  (and preferably to the plunger  130 ). Tension may be created by the distal force applied near the distal end  122  of the catheter assembly  120  and the proximal force applied near the proximal end  121  of the catheter assembly  120 . When the device is moved from the locating state to the tension state, the width  163  of the expandable support  160  may increase from the locating width  163   b  to the tension width  163   c , and the length  164  of the expandable support  160  may decrease from the locating length  164   b  to the tension length  164   c . The device status indicator  104  may indicate whether the appropriate amount of tension is being applied. If the device status indicator  104  shows that too much or too little tension is being applied to the catheter assembly  120 , the user may decrease or increase (respectively) the proximal force applied to the handle  110  and/or core wire  150  until the device status indicator  104  shows that an appropriate amount of tension is being applied to the catheter assembly  120 . Contacting a tension stop  126  on the catheter assembly  120  with a tension stop  116  on the handle  110  may also prevent the user from applying too much tension to the catheter assembly  120 . A locating lock may remain engaged as the device moves from the locating state to the tension state in order to prevent the device from moving to the resting state. 
     If the expandable support  160  is a balloon, the balloon may remain inflated as the arteriotomy positioning device  100  is moved between the locating state and the tension state. Although shape of the balloon may change as the device  100  is moved between the locating state and the tension state, the amount of inflation fluid in the device may remain substantially constant. Therefore, a valve associated with the inflation port may remain closed as the device is moved between the locating state and the tension state. 
     When the device status indicator  104  shows that an appropriate amount of tension is being applied to the catheter assembly  120 , the user can perform the intended procedure (e.g., applying a sealant or other closure device, in the case of a vascular closure procedure). The proximal force applied to the handle  110  and/or core wire  150  may be maintained throughout at least a portion of the procedure, such that the device status indicator  104  continues to show that an appropriate amount of tension is being applied to the catheter assembly  120 . 
     After completion of the procedure, the user may return the arteriotomy positioning device  100  to its resting state. The proximal force applied to the handle  110  may be decreased, thereby releasing the tension on the catheter  140 , allowing the catheter assembly  120  to move proximally relative to the handle  110  and the core wire  150 , and returning the device to the locating state. A locating lock may be disengaged, and the catheter assembly  120  may be moved further proximally relative to the handle  110  and the core wire  150  to return the device  100  to its resting state. If the expandable support  160  is a balloon, the locating lock may be disengaged by opening a valve associated with the inflation port  114 , which allows inflation fluid to exit the fluid chamber  113  through the inflation port  114  on the handle  110 , causing the balloon to deflate and the device  100  to return to its resting state. 
     When the arteriotomy positioning device  100  has been returned to its resting state, the expandable support  160  may have the resting width  163   a  smaller than the width of the arteriotomy  002 . Therefore, the expandable support may fit through the arteriotomy  002  and the device  100  may be removed from the patient. A proximal force may be applied to the handle  110 , and the entire arteriotomy positioning device  100  may be withdrawn from the patient. 
     Various other components may be provided within the arteriotomy positioning device  100 . In addition, the arteriotomy positioning device  100  may also be incorporated into other devices used in procedures that require access to a patient&#39;s vasculature. For example, the arteriotomy positioning device  100  may be incorporated into a vascular closure device. The vascular closure device may further incorporate features including a sealant, a pusher member, a protective sleeve, and various other components. The sealant may be positioned near the distal end of the catheter assembly, proximal to the expandable member. The pusher member may be positioned proximal to the sealant to prevent proximal movement of the sealant and/or tamp the sealant. The sealant and pusher member may be provided inside a protective sleeve, which may be withdrawn to deploy the sealant. Incorporating the arteriotomy positioning devices discussed above into a vascular closure device may help ensure that the sealant is positioned correctly (outside the blood vessel, but near the arteriotomy) before the user deploys and/or tamps the sealant. The device may further include additional components, actuators, and/or safety mechanisms for controlling the device while exposing the sealant, tamping the sealant, withdrawing the cartridge assembly and expandable support relative to the sealant and/or the protective sleeve. 
     A number of alternative embodiments of arteriotomy positioning devices are envisioned, including those shown in  FIGS. 6-11 . Several of the alternative embodiments may have one or more features in common. Other embodiments may have a handle, a catheter assembly, a core wire, and an expandable member. The core wire may be substantially fixed relative to the handle, at least while the device is in the locating and/or tension states. The catheter assembly may include a plunger substantially fixed relative to a catheter. The catheter assembly may be moveable relative to the handle and the core wire. The proximal end of the expandable support may be connected to the catheter, and the distal end of the expandable support may be connected to the core wire. The distance between distal end of the expandable support and a distal end of the handle may be substantially fixed, at least while the device is in the locating and/or tension states, whereas the proximal end of the expandable support may be moveable relative to the handle. The proximal end of the expandable support may be biased proximally, but moveable distally relative to the handle in response to various forces applied to the device. Applying tension to the catheter assembly may increase the width of the expandable support. The device may also have a device status indicator capable of indicating both the configuration of the expandable support and an amount of tension being applied to the catheter assembly. The exemplary alternative embodiments shown in  FIGS. 6-11  show different configurations of arteriotomy positioning devices. It is understood that one of ordinary skill in the art would understand that one or more features from one embodiment may be combined with other features from other embodiments. 
       FIG. 6  shows an alternative embodiment of an arteriotomy positioning device  600 , wherein the plunger  630  does not extend into the fluid chamber  113 . Device  600  is similar to device  100 , except for the catheter assembly  620  (specifically, the plunger  630 ) and the seal  618  (specifically, the channel  619  in the seal  618 ) may differ from catheter assembly  120  and seal  118 .  FIG. 6  shows an embodiment with the plunger  630  positioned entirely outside the fluid chamber  113  of the handle  110 . Both the resting stop  627  and the tension stop  626  of the catheter assembly  620  may be positioned outside the fluid chamber  113 . The seal  618  may form a resting stop on the handle  110  to limit proximal movement of the catheter assembly  620 . A surface of the handle  110  (in  FIG. 6 , this surface may be a distal surface of the inner housing  110   a ) may form a tension stop on the handle  110  to limit proximal movement of the core wire  150  and/or housing  110  relative to the catheter assembly  620 . The channel  619  in the seal  618  may have a smaller diameter in order to seal to the catheter  140 , since the plunger  630  does not extend through the channel  619  in the seal  618 . 
       FIG. 7  shows another alternative embodiment of an arteriotomy positioning device  700  wherein the handle  110  includes a fluid chamber  713 , but not a second chamber. Device  700  is similar to device  100 , except the handle  710  (specifically, the inner housing  710   a ) and the catheter assembly  720  (specifically, the plunger  730 ) may differ from the handle  100  and catheter assembly  120  of device  100 . The spring  170  is shown as being positioned in the fluid chamber  713  in  FIG. 7 ; however, it could also be positioned outside the fluid chamber  713 , but within the handle  710 . For example, a spring may be inserted over the catheter  140 , such that the distal end of the spring  170  may contact a surface on the handle  710  (possibly the distal end  712  of the handle  710 ), and the proximal end of the spring may contact a surface on the plunger  730  (possibly the distal end  732  of the plunger  730 ). Additionally, the handle  710  of  FIG. 7  shows proximal and distal seal retaining walls  718   a ,  718   b  which are one way in which the seal  718  may be secured in the handle. These seal retaining walls may be applied to various other embodiments in order to maintain the position of the seal relative to the handle. 
     Another unique feature of  FIG. 7  is the fact that the proximal end  721  of the catheter assembly  720  forms the resting stop  727 . The catheter assembly  720  may include a transverse channel  728  that communicates with the lumen  725  of the catheter assembly  720 , as shown in  FIG. 7 . The transverse channel  728  may allow fluid to move from the inflation port  114  and into the lumen  725  of the catheter assembly  720  when the device  700  is in the resting position, as shown in  FIG. 7 . This concept could also be applied to embodiments with both a fluid chamber and a second chamber. Alternatively, the plunger could be designed such that the resting stop of the plunger may be located outside the fluid chamber  713 , such that the resting stop may rest on the distal-most surface of the inner housing  710   a  when the device  700  is in the resting position. 
       FIG. 8  shows still another alternative embodiment of an arteriotomy positioning device  800  having an alternative device status indicator. Device  800  is similar to device  100 , although the handle  810  (specifically, the outer housing  810   b ) and catheter assembly  820  (specifically, the plunger  830 ) may differ from handle  110  and catheter assembly  120 . The indicator feature  805  is on the handle  810  and the markings  806  are on the catheter assembly  820 . The indicator feature  805  may be a window in the handle  110 . The window may be sized to show and/or align with one of the markings  806  at a time, thereby allowing the user to determine the status of the device as the markings  806  (shown as raised features in  FIG. 8 ) on the catheter assembly  820  slide past the window on the handle  810 . 
       FIG. 9  shows yet another exemplary embodiment of an arteriotomy positioning device  900 . Device  900  is similar to device  100 , except that the handle  910  and catheter assembly  920  (specifically, the plunger  930 ) may differ from handle  110  and catheter assembly  120 . In this embodiment, the indicator feature  905  also functions as a resting stop. The spring  170  is located inside the handle  910 , but outside the fluid chamber  113 . The spring-contacting surfaces may be a distal end  932  of the plunger  930  and a distal end  912  of the outer housing  910   b.    
       FIG. 10  shows another exemplary embodiment of an arteriotomy positioning device  1000 . Device  1000  is similar to device  100 , except the handle  1010  of device  1000  may differ from the handle  110  of device  100 . The handle  1010  of device  1000  does not have an inner housing and an outer housing, but instead may be formed from a single housing. The indicator feature  1004  is an indication of relative movement between the catheter assembly  1020  and the handle  1010 . The handle  1010  may include a window  1007  that allows the user to see the indicator feature  1005  on the catheter assembly  1020  (and preferably on the plunger  1030 ). The markings (not shown in  FIG. 10 ) may be adjacent the window  1007  on an outer surface of the housing  1010 . 
       FIG. 11  shows yet another exemplary embodiment of an arteriotomy positioning device  1100  having an alternative device status indicator  1104 . Device  1100  is similar to device  1000 , except the handle  1110  and catheter assembly  1120  may differ from the handle  1010  and catheter assembly  1020  of the device  1000 . Specifically, the indicator feature  1105  may simply be a distal opening  1115  in the handle  1110 . A series of markings  1106  on the catheter assembly  1120  (and preferably, on the outer surface  1133  of the plunger  1130 ) may slide relative to the distal opening  1115 , and the marking  1106  that is aligned with the distal opening  1115  may indicate the status of the device  1100 . The window  1007  in the handle  1010  and the protrusion that formed the indicator feature  1005  of  FIG. 10  may be omitted in device  1100 . This device status indicator  1104  may also be applied to other embodiments of arteriotomy positioning devices. 
     The device may be modified if the expandable support is not an inflatable balloon. For example, the inflation port, fluid chamber, valve, and seal in the handle may be omitted. The device may be moved from the resting state to the locating state by moving the catheter assembly distally relative to the core wire (or by moving the core wire proximally relative to the catheter assembly), which can be accomplished manually or with an actuator or control mechanism in the handle. In either case, the device should still be able to move freely between the locating state and the tension state, regardless of how the device is moved from the resting state to the locating state. The device may have one or more locking features to maintain the position of the catheter assembly. For example, a resting lock may prevent distal movement of the catheter assembly relative to the handle and the core wire when the device is in a resting state. Once the device is moved to the locating state, a locating lock may limit proximal movement of the catheter assembly relative to the handle and the core wire, while still allowing the device to move between the locating state and the tension state. 
       FIG. 12A  is a perspective view of an alternative embodiment for an expandable support  1260  in a resting state. The expandable support  1260  is configured to be connected to an arteriotomy positioning device such as the positioning device  100  described with reference to  FIGS. 1A-5C , and with a handle embodiment as described below with reference to  FIGS. 13A-C . 
     In the embodiment depicted in  FIGS. 12A-C , the expandable support  1260  is an expandable wire mesh that can move between a low-profile configuration (shown in a resting state in  FIG. 12A ), a medium-profile configuration (shown in a locating state in  FIG. 12B ), and a high-profile configuration (shown in an expanded state in  FIG. 12C ). 
       FIG. 12B  is a perspective view of the arteriotomy positioning device of  FIG. 12A  in a locating state. As noted above, the locating state may also be referred to herein as a medium-profile configuration. If the expandable support  1260  is in the shape of a sphere or ellipsoid, its width would be the maximum diameter of the expandable support  1260  in a direction substantially perpendicularly to a longitudinal axis of the device  100 . As will be described below, the length and the width of the expandable support  1260  may change as the expandable support  1260  is moved between the low-profile configuration, the medium-profile configuration, and the high-profile configuration. 
     The expandable support  1260  may be connected to a catheter, such as catheter  140  for example, and a core wire, such as the core wire  150  for example. 
     The length of the expandable support  1260  may change if a catheter assembly is moved relative to a core wire, allowing the expandable support  1260  to move between the low-profile configuration, the medium-profile configuration, and the high-profile configuration. Generally, the length may decrease and the width may increase as the expandable support  1260  moves from the low-profile configuration to the medium-profile configuration to the high-profile configuration. 
       FIGS. 13A-C  depict an example handle  1300  comprising a plunger  1310  that may be used with the expandable support of  FIGS. 12A-C . In some embodiments, the handle  1300  may comprise a number of features similar to the handle  110 . Certain features specific to the embodiment of  FIGS. 13A-C  will be described in further detail below. 
       FIG. 13A  depicts a cross-section view of the handle  1300  used with the expandable support of  FIG. 12A  in a resting state, shown from the side. In  FIG. 13A , the plunger  1310  is shown in a locked position with a lock  1320  that prevents the plunger  1310  from movement, resulting in the expandable support  1260  remaining in the low-profile configuration or resting state. 
     In operation, once a user has inserted the device into a patient&#39;s artery, the user can unlock the lock  1320  on the plunger  1310 , allowing for movement of the plunger  1310  to the position shown in  FIG. 13B .  FIG. 13B  is a cross-section view of the handle of  FIG. 13A  used with the expandable support of  FIG. 12B  in a locating state, shown from the side. 
     As shown in  FIG. 13B , the plunger  1310  movement in the distal direction within the handle  1300  applies force to the expandable support  1260 . The applied force causes expansion of the expandable support  1260 , and results in a partial expansion of the expandable support  1260 , as shown in the medium-profile configuration or the locating state in  FIG. 12B . 
       FIG. 13C  is a cross-section view of the handle of  FIG. 13A  used with the expandable support of  FIG. 12C  in an expanded state, shown from the side. As the plunger  1310  moves distally within the handle  1300 , the plunger contacts and engages a spring  1330  present within the handle  1300 . Continual distal movement of the plunger  1310  applies pressure to and compresses the spring  1330 , resulting in the configuration depicted in  FIG. 13C . As the user retracts the device and the expandable support  1260  presses against the arteriotomy, tension on the plunger  1310  provides for further expansion of the expandable support  1260 , resulting in the high-profile configuration shown in  FIG. 12C . The spring  1320  provides friction and in turn controls the rate of expansion of the expandable support  1260 . 
     As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective of the arteriotomy positioning devices. Thus, proximal refers to the direction of the handle and distal refers to the direction of the expandable member. 
     For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. The foregoing description is provided to enable any person skilled in the art to practice the various example implementations described herein. Various modifications to these variations will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations. All structural and functional equivalents to the elements of the various illustrious examples described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference.