Patent Publication Number: US-2020276414-A1

Title: Secondary manipulator for a steering catheter

Description:
RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 62/812,111, filed on Feb. 28, 2019, and titled SECONDARY MANIPULATOR FOR A STEERING CATHETER, which is incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to devices used to manipulate elongated medical instruments. More specifically, the present disclosure relates manipulator devices used to axially translate and/or rotate a distal portion of an elongated body of an elongated medical instrument, such as a steerable vascular catheter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which: 
         FIG. 1  is a perspective view of an embodiment of a secondary manipulator device coupled to an elongated medical instrument. 
         FIG. 2  is an exploded perspective view of the secondary manipulator device of  FIG. 1 . 
         FIG. 3  is a perspective view of a retention member of the secondary manipulator device of  FIG. 1 . 
         FIG. 4A  is a cross-sectional view of the secondary manipulator device of  FIG. 1  with the retention member in an open state. 
         FIG. 4B  is a cross-sectional view of the secondary manipulator device of  FIG. 1  with the retention member in a securing state. 
         FIG. 5  is a perspective view of the secondary manipulator device of  FIG. 1  with the retention member in an open state. 
         FIG. 6A  is a top view of the secondary manipulator device of  FIG. 1  with the retention member in the open state. 
         FIG. 6B  is a top view of the secondary manipulator device of  FIG. 1  with the retention member in the open state and with an intermediate portion of an elongated body of the elongated medical instrument disposed in an insertion path. 
         FIG. 6C  is a top view of the secondary manipulator device of  FIG. 1  with the retention member in the securing state and with the intermediate portion of the elongated body of the medical instrument disposed in a channel. 
         FIG. 7  is a top view of an operator manipulating the elongated medical instrument using the secondary manipulator device of  FIG. 1  and a primary manipulator device. 
         FIG. 8  is a perspective unassembled view of another embodiment of a secondary manipulator device. 
         FIG. 9  is a perspective view of an embodiment of the secondary manipulator device of  FIG. 8  coupled to an elongated medical instrument. 
         FIG. 10  is a perspective cross-sectional view of another embodiment of a secondary manipulator device. 
         FIG. 11  is a perspective view of an embodiment of the secondary manipulator device of  FIG. 10  coupled to an elongated medical instrument. 
     
    
    
     DETAILED DESCRIPTION 
     Various medical procedures involve the use of one or more elongated instruments. As used herein the term “elongated instrument” is directed to devices such as catheters (e.g., ablation catheters, electrogram catheters, diagnostic catheters, sensing catheters, temporary pacemaking catheters), steering sheaths, cannulae, guidewires, sensor wires, electrical cables, tubes, support lines, etc. Such elongated instruments can include a distal end and a proximal end. In some arrangements, the distal end of an elongated medical instrument, such as a catheter, can be introduced into the patient in any suitable manner, such as, for example, via a sheath introducer and accompanying techniques. The elongated instrument may, for example, be said to enter the patient at an insertion site. The distal end of the elongated instrument may be advanced to a desired position within the patient. In some instances, a proximal portion and/or an intermediate portion of the elongated instrument may be rotated or otherwise manipulated while the distal end is advanced to the desired position. Such rotation and/or other manipulation may give rise to a torque about the longitudinal axis of the elongated instrument. Such torque can cause the distal end of the elongated instrument to move, turn, bend, or otherwise change directions. 
     In some instances, control over the location of the distal end of the elongated instrument can be difficult. For example, manipulating the proximal end of the elongated instrument may not adequately control the distal end. For instance, the intermediate portion of the elongated instrument may respond to movement of the proximal end rather than the distal end. Slack or regions of the intermediate portion of the elongated instrument outside the patient&#39;s body can thus increase the difficulty of various medical procedures, such as cardiac ablation and mapping procedures. The secondary manipulator devices disclosed herein can aid in overcoming these problems by enabling a practitioner to control the elongated instrument at various locations along the elongated instrument. The secondary manipulator devices disclosed herein can also be used to maintain the torque at the proximal or intermediate region to maintain the distal end in a desired orientation within the patient. 
     As an example, in various instances, one or more catheters may be inserted into a patient in electrophysiology or cardiology procedures. In certain of such procedures, one or more of an electrogram-detecting catheter, a mapping catheter, a diagnostic catheter, an ablation catheter, a steering catheter or a steering sheath may be introduced into a patient. In some instances, a practitioner may advance the distal end of a catheter or sheath to a desired position within the patient by manipulating (e.g., via a hand or a primary manipulation device) more proximal regions of the catheter at an exterior of the patient. A secondary manipulation device disclosed herein can be further employed at an intermediate portion of the catheter or sheath to aid in advancing the distal end of such catheter or sheath. The secondary manipulation device can further be used to control the movement and/or location of the distal end. This can be especially helpful when conducting a cardiac mapping and/or ablation procedure where precise control is advantageous. These and other embodiments are further discussed below. 
     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. 
     It will be appreciated that 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. 
     Unless otherwise defined, 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 or closest to the patient&#39;s body during use. The proximal end refers to the opposite end, or the end nearest the practitioner or furthest from the patient&#39;s body during use. 
       FIGS. 1-11  illustrate different views of several secondary manipulator devices 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. 1-7  depict an embodiment of a secondary manipulator device  100  and related methods of use. As detailed below, the secondary manipulator device  100  comprises a retention member  102  and a handle  170 . In  FIG. 1 , the secondary manipulator device  100  is shown coupled to an elongated medical instrument  190 . The illustrated elongated medical instrument  190  is a steerable vascular catheter. In other embodiments, the elongated medical instrument  190  may be another suitable device, such as other types of catheters (e.g., ablation catheters, electrogram catheters, diagnostic catheters, sensing catheters, temporary pacemaking catheters), steering sheaths, cannulae, guidewires, sensor wires, etc. An elongated body  195  of the elongated medical instrument  190  includes a proximal portion  191 , an intermediate portion  192 , and a distal portion  193 . 
     As shown in  FIG. 1 , in the illustrated embodiment, the elongated medical instrument  190  (e.g., steering catheter) comprises both a primary manipulator device  194  and a secondary manipulator device  100 . The primary manipulator device  194  is coupled to a proximal portion  191  of the elongated body  195  and is configured to control the shape of the distal portion  193  of the elongated body  195 . For example, the primary manipulator device  194  may include an actuator  196  that can be actuated (e.g., rotated), shown as S IN , to deform the shape of the distal end  197 , shown as S OUT . In certain embodiments, the actuator  196  can be actuated to bend or otherwise turn the distal end  197  of the elongated body  195 . 
     As further shown in  FIG. 1 , the secondary manipulator device  100  can be selectively coupled to an intermediate portion  192  of the elongated body  195 . In other words, the secondary manipulator device  100  can be selectively coupled to the elongated body  195  at a location that is between the distal portion  193 , which may be disposed within the patient&#39;s body, and the proximal portion  191 , which may comprise a primary manipulator device  194 . The location of the secondary manipulator device  100  along the elongated body  195  can also be adjusted by the practitioner to achieve a desired location. At the user&#39;s discretion, the secondary manipulator  100  can be manipulated to further control the distal portion  193  of the elongated body  195 . For instance, the secondary manipulator  100  can be manipulated to control a rotation and/or axial translation of the distal end  197 , which may be disposed inside a patient. 
     With reference to  FIG. 1 , the secondary manipulator device  100  can be axially translated, shown as T″ IN , relative to the primary manipulator device  194 . For instance, the secondary manipulator device  100  can be axially translated relative to the primary manipulator device  194  within an extent of slack of the elongated body  195  between the primary manipulator device  194  and the secondary manipulator device  100 . When coupled to the elongated body  195 , axial translation of the secondary manipulator device  100  (T″ IN ) can result in axial translation of the distal portion  193  of the elongated body  195 , shown as TOUT. The secondary manipulator  100  can also be rotated, shown as R″ IN , about a longitudinal axis of the elongated body  195 . When coupled to the elongated body  195 , rotation of the secondary manipulator device  100  (R″ IN ) can result in rotation of the distal portion  193  of the elongated body  195 , shown as ROUT. 
     In some embodiments, the secondary manipulator  100  can be rotated about a longitudinal axis of the elongated body  195  relative to the primary manipulator device  194  within the extent of the torsional strain limits of the material of the elongated body  195  between the rotationally constrained primary manipulator device  194  and the torqued secondary manipulator device  100 . In certain embodiments, the secondary manipulator device  100  can be rotated at least 180 degrees, 360 degrees, or even several rotations relative the primary manipulator device  194  without adversely affecting the elongated body  195 . For instance, the diameter of the elongated body  195  can be relatively small and/or the elongated body  195  can comprise plastic and/or other elastomeric materials such that the secondary manipulator device  100  can be rotated without adversely affecting the elongated body  195 . 
       FIG. 2  is an exploded perspective view of the secondary manipulator device  100  of  FIG. 1 . In the depicted embodiment, the secondary manipulator device  100  includes a retention member  102  and a handle  170 . The retention member  102  can generally correspond with a portion of the secondary manipulator device  100  that is configured to retain at least a portion of the elongated medical instrument to facilitate manipulation of a distal portion of the elongated medical instrument (see e.g.,  FIG. 1 ). The handle  170  can aid in the introduction of the intermediate portion of the elongated medical instrument into the retention member  102  and can provide a hand grip for manipulation of the secondary manipulator device  100  by a user. For example, as discussed below, in some instances the handle  170  can provide a desired insertion path  173  along which the elongated medical instrument can be introduced into the retention member  102 . For instance, the intermediate portion  192  of the elongated body  195  can be inserted into the secondary manipulator device  100  without passing an end (e.g., distal end or proximal end) of the elongated body through the insertion path  173 . In other or further embodiments, the handle  170  can include one or more features that assist in maintaining the elongated medical instrument within the retention member  102 . Moreover, in some embodiments, an insertion path  173  defined by the handle  170  may also serve as an exit path along which the elongated instrument may be removed from the secondary manipulator device  100 . 
     In the illustrated embodiment, the retention member  102  and the handle  170  are each formed by distinct pieces. Such distinct pieces can be temporarily fixed, or permanently coupled together in any suitable manner. In other embodiments, a unitary piece of material may define at least a portion of each of the retention member  102  and the handle  170 . For example, in some embodiments, the entire secondary manipulator device  100  may be molded as a monolithic, unitary piece of material. In other embodiments, one or more of the retention member  102  and the handle  170  can be molded and subsequently coupled together. 
     In the illustrated embodiment shown in  FIG. 3 , the retention member  102  includes a channel  110  (which may also be referred to as a retention channel), an opening  112  (which may also be referred to as an insertion opening and/or as an exit opening), and a lock  114 . An elongated medical instrument (see  FIG. 1 ) can be introduced into the retention member  102  and/or removed from the retention member  102  via the opening  112 . When used with the handle  170 , the opening  112  can be positioned between the retention member  102  and a wall of the handle  170 . Accordingly, in the illustrated embodiment, the retention member  102  and the handle  170  can cooperate to define the opening  112  (See  FIGS. 6A-6C ). 
     The channel  110  can be configured to receive an elongated medical instrument therein. In some embodiments, the channel  110  may be sized to receive elongated medical instruments that have a variety of different diameters or that have a variety of different maximum cross-sectional areas (e.g., where each cross-sectional area is taken along a plane that is perpendicular to a longitudinal axis of the elongated instrument). 
     The lock  114  can be configured to transition between an open state and a securing state, which may also be referred to as a closed state. The lock  114  can be used to selectively retain the elongated medical instrument in the channel  110  when in the securing state. In the illustrated embodiment, the lock  114  includes a retention arm  130 , which may also be referred to as a spring, or spring member, and further includes a seat  160 . The retention arm  130  and the seat  160  are configured to interact with each other to retain the elongated medical instrument within the channel  110 . In the illustrated embodiment, at least a portion of each of the retention arm  130  and the seat  160  define portions of the channel  110 . Stated otherwise, at least a portion of the channel  110  may extend between the retention arm  130  and the seat  160 . Other limits, contours, or boundaries of the illustrated channel  110  are further detailed below. 
     As further discussed below, the lock  114  can further include a latch  140  that is configured to selectively interact with a locking arm  150 , which may also be referred to as a locking member, to transition the lock  114  between the open and the securing states. In particular, the latch  140  may selectively retain an end of the locking arm  150 , which can permit the retention arm  130  to press against the elongated instrument within the channel  110 . Releasing the latch  140  can permit the locking arm  150  and the retention arm  130  to return to a natural state in which the elongated medical instrument is no longer restrained by the holding device  100 , as discussed further below. 
     As illustrated in  FIGS. 4A and 4B , the retention arm  130  can move toward the seat  160  as the lock  114  is transitioned from the open state (shown in  FIG. 4A ) to the securing state (shown in  FIG. 4B ) and can move away from the seat  160  as the lock  114  is transitioned from the securing state to the open state. The retention arm  130  is coupled to the locking arm  150 . Movement of the locking arm  150  can affect movement of the retention arm  130 . The retention arm  130  may be connected to the locking arm  150  at a hinge  136 , which may also be referred to as an elbow, joint, transition region, or pivot. 
     With continued reference to  FIG. 3 , in the illustrated embodiment, the retention arm  130  comprises an elongated body  131  that extends between opposing ends  132 ,  134 . The end  132  may be referred to as a distal end, and the end  134  may be referred to as a proximal end, with the distal and proximal terms being based on proximity to the hinge  136 . In some embodiments, the body  131  comprises a flexible material. In further embodiments, the body  131  may be resiliently flexible so as to be able to repeatedly transition from a resting or natural state to a displaced or deformed state, and further, return to the natural state. In still further embodiments, the hinge  136  may be flexible. In the illustrated embodiment, the body  131  is substantially planar when in the natural state and is deflected to a bent orientation when in a displaced or deformed state. In other embodiments, the body  131  may be curved or bent when in the natural state. In the illustrated embodiment, the hinge  136  and the body  131  are integrally formed of a unitary monolithic piece of material. 
     In the illustrated embodiment, the retention arm  130  and/or the elongated body  131  is also substantially flexible such that the elongated body  131  can substantially conform to the shape of an elongated instrument disposed within the channel  110  of the retention member  102 . For instance, the retention arm  130  may conform along a point or line of contact between the retention arm  130  and the elongated instrument. The contact may be with or without a gripper  181 , and the shape of the portion of the elongated body  131  may substantially conform to the shape of the elongated instrument (or surface thereof). For instance, a portion of the elongated body  131  can bend to form a continuous point or line of contact along an upper surface of the elongated instrument. The line of contact can be disposed on and extend along a longitudinal length of the elongated instrument. In other words, the line of contact can be disposed along a surface of the elongated instrument that is substantially parallel with a longitudinal axis of a lumen extending through the elongated instrument. 
     The retention arm  130  is also resiliently flexible such that the shape of the elongated body  131  or engaged portion of the arm  130  in contact with the elongated instrument (or the seat  160  if no elongated instrument is disposed within the channel  110 ) will substantially return to the open state when the lock  114  is released, and then reform to take the shape of an elongated instrument (or the seat  160 ) when in the securing state. In certain embodiments, the retention arm  130  is further configured to apply pressure to (e.g., squeeze) the elongated instrument within the channel  110  when in the securing state. The combination of the contact surface area between the retention member and the elongated instrument, the force applied between the retention arm  130  and the seat  160  onto the engaging surfaces of the elongated instrument (e.g., upper and lower engaging surfaces), and the friction between the engaging surfaces exceeds the forces induced on the elongated instrument when the instrument is manipulated both in rotational and translational movements. The holding force can maintain the relative position of the elongated instrument without substantially deforming the cross-sectional shape of the elongated instrument. In some embodiments, the engagement surface area exceeds the cross-sectional area of the elongated instrument. In other embodiments, it may be at least about 5 times, about 10 times, or about 100 times greater than the cross-sectional area. In some embodiments, a longitudinal line of contact between the retention arm  130  and the elongated instrument establishes the engagement. The length of engagement can be longer than the perimeter of the transverse cross-section perimeter of the elongated instrument. In some embodiments, it is at least about 2 times, about 5 times or about 10 times greater than the length of the perimeter. Without limitation, the application of pressure by the retention arm  130  can be similar to pinching something between a thumb and side of a forefinger. This application of pressure can also create enough force or friction along the engaged surface of the elongated instrument to overcome forces that cause the elongated instrument to want to move, rotate, or slide within the channel  110 . Thus, this application of pressure can substantially retain or otherwise fix the position of the elongated instrument relative to the retention member  102 . Further, the application of pressure can be distributed along the engaged surface of the elongated instrument such that the position of the elongated instrument can be retained without collapsing or otherwise closing a lumen of the elongated instrument (e.g., without forcing two opposing sides of the elongated instrument together). 
     In other embodiments, the body  131  of the retention arm  130  may be relatively stiff or inflexible. In such embodiments, the retention arm  130  may be configured to flex only at the hinge  136 . The distal end  132  of the body  131  may be able to grip the elongated medical instrument  195  as the retention arm  130  is urged toward the seat  160  and as potential energy is stored in the hinge  136  as the lock  114  is transitioned to the securing state. The hinge  136  may be resiliently flexible to return the body  131  to a natural or resting state when the lock  114  is returned to the open state. 
     The retention arm  130  may be moved via the locking arm  150 . For example, in some instances, it may be said that the retention arm  130  is moved indirectly via the locking arm  150 , as the locking arm  150  is directly contacted (e.g., via a finger of a practitioner) to effect movement of the retention arm  130 . Stated otherwise, the locking arm  150  may be used to actuate the retention arm  130 , or to cause the retention arm  130  to interact with the seat  160  or with an elongated medical instrument that is positioned between the retention arm  130  and the seat  160 . The locking arm  150  may include a grip  154  for this purpose. In the illustrated embodiment, the grip  154  is a region of increased thickness  155 , which can reinforce the locking arm  150 . The grip  154  can include a region of increased friction  155  of any suitable variety, in some embodiments, such as a series of ridges and/or bumps, a different material having an increased coefficient of friction (e.g., an elastomeric material such as rubber), and/or any other suitable gripping feature. In some embodiments, the grip  154  may be used as a locating feature, which may provide visual and/or tactile information regarding a position at which the locking arm  150  can be touched to cause the arm to actuate to the securing state. The outer contours of the region of increased friction  155  is depicted as a substantially square region in  FIG. 3 . 
     The locking arm  150  can be connected to the seat  160  via a hinge  152 . In the illustrated embodiment, the hinge  152  defines a larger radius of curvature than does the hinge  136 . In various embodiments, the hinge  152  may have a different flexibility than does the hinge  136 . In other embodiments, the hinges  136 ,  152  have substantially the same flexibility. In certain embodiments, the locking arm  150  may be configured to function as a resilient spring in manners that are the same or similar to the retention arm  130 . For example, in the illustrated embodiment, the locking arm  150  can be relatively stiff or inflexible, and this substantial rigidity may be reinforced by the grip  154 , which, as previously discussed, may include a region of increased thickness. The locking arm  150  may nevertheless pivot via the hinge  152 , which can store potential energy as the lock  114  is transitioned from the open state to the securing state. The hinge  152  may be resiliently flexible to permit repeated transitions between the open and securing states. 
     When the latch  140  releases the distal end of the locking arm  150 , the potential energy stored in the hinge  152  can automatically transition the locking arm  150  to its natural state. The potential energy stored in the hinge  136  may likewise assist in returning the locking arm  150  to its natural state, at least during a period in which the retention arm  130  interacts directly or indirectly (e.g., via the elongated medical instrument  190 ) with the seat  160 . 
     In the illustrated embodiment, a notch  153  is provided in the hinge  152 . The notch  153  defines a first end of the channel  110  through which the elongated medical instrument can pass. The first end of the channel  110  can correspond with a first end  106  of the retaining member  102 . The device can further define a second end  108  that is opposite from the first end  106 . The terms “first” and “second” do not necessarily denote a preferred orientation of the retaining member  102 . For example, in some instances, the first end  106  may be directed toward an insertion site at which the elongated medical instrument enters the patient, whereas in other instances, the second end  108  may be directed toward the insertion site. 
     A distal end of the locking arm  150  (as determined based on proximity to the hinge  152 ) can include an angled face  156  that is configured to assist in transitioning the lock  114  to the securing state, as discussed further below. The distal end may include another angled face  158  that is configured to assist in maintaining the lock  114  in the securing state, as discussed further below. 
     With continued reference to  FIG. 3 , the latch  140  can include a grip  142 , which may resemble the grip  154  discussed above. For example, the grip  142  may be manipulated in a direction away from the first end  106  of the retention member  102  to release the locking arm  150  and thus transition the lock  114  from the securing orientation to the open orientation. In the illustrated embodiment, the grip  142  is positioned on a protrusion that extends generally upwardly at the second end  108  of the retention member  102 . 
     The latch  140  can include an angled face  144  that is configured to interact with the angled face  156  of the locking arm  150  as the holding device  100  is transitioned from the open state to the closed state. In particular, the faces  144 ,  156  may be configured to slide past one another in a manner that causes the latch  140  to be urged outwardly toward the second end  108  of the holding device  100  as the locking arm  150  is pressed downwardly toward the seat  160 . 
     The latch  140  can further include a retaining face  146  that is configured to interact with the face  158  of the locking arm  150  to maintain the holding device  100  in the closed state. In particular, after the locking arm  150  has been compressed downwardly toward the seat  160  by a sufficient amount, the latch  140  is deflected away by the interference between surface  156  and surface  144  as the locking arm rotates about hinge  152  and the latching arm rotates about hinge  148  and can spring back to a natural position. In this position, the face  146  may be above the face  158 . When the compressive force is no longer applied to the locking arm  150 , the locking arm  150  may be permitted to begin a resilient return to its natural state. However, the retaining face  146  can engage the face  158  of the locking arm  150  to prevent the arm from fully returning to its natural position, thus maintaining the holding device  100  in the closed state. 
     Locks  114  other than that described above with respect to the latch  140  and the locking arm  150  are also possible. For example, the locking arm  150  and the retention arm  130  may be retained in a compressed state via a separate clamp (not shown), such as a ratcheting vice grip, that provides compressive forces to a bottom of the seat  160  and a top of the locking arm  150  at the first end  106  of the holding device  100 . Any other suitable locking arrangement is also contemplated. The illustrated embodiment of the lock  114  can be advantageous in some instances, as the lock  114  may be manipulated into the securing state and/or may be manipulated into the open state by a practitioner with the use of a single hand. 
     In some embodiments, the lock  114  may be moved to each of the securing state and the open state by urging separate components thereof generally in the same direction. For example, as shown in  FIGS. 4A and 4B , and discussed further below, generally downward forces may be applied separately to the locking arm  150  and the latch  140  to separately transition the lock  114  to the securing state and the open state, respectively. Such an arrangement can be advantageous, in some instances, as the retention member  102  can be disposed within a handle. Thus, in some instances, the retention member  102  may be manipulated via a single finger while it is disposed within a handle. In other instances, the handle and retention member  102  may be held within a practitioner&#39;s hand, such as within a closed fist, and the curled fingers of a hand may provide the reactive surface while the thumb, or a single finger, may be used to manipulate either the locking arm  150  or the latch  140  to effect closing or opening of the lock  114 , respectively. 
     In the illustrated embodiment, a notch  153  is also provided in the hinge  148  of the latch  140 . The notch  153  defines a second end of the channel  110  through which the elongated instrument can pass. The second end of the channel  110  can correspond with the second end  108  of the holding device  100 . 
     In the illustrated embodiment, the seat  160  extends longitudinally between the hinges  152 ,  148 . The seat  160  can be arranged as a platform against which the elongated medical instrument can rest. In some embodiments, the seat  160  defines a substantially planar surface. A base  161  of the retention member  102  can include the seat  160 . In the illustrated embodiment, the base  161  further includes a support  162  that extends outwardly from a neck  164  toward each of the first and second ends  106 ,  108  of the retaining member  102 . In the illustrated embodiment, the neck  164  is oriented between the seat  160  and the support  162 . Portions of the seat  160  that are not constrained by the support  162  can contribute to the flexibility of the hinges  152  and  148  to allow the hinges to deflect elastically as the holding device  100  is changed between the holding state and the open state. The support  162  can stabilize the retaining member  102  during use thereof. The support  162  can also be used to couple the retaining member  102  to a handle  170  or other device. In some instances, material costs may be reduced by providing spaces between the seat  160  and the support  162 . The neck  164  can permit such spacing. 
     In some embodiments, the retention arm  130  and/or the seat  160  can include one or more gripping surfaces  181 ,  182  to increase frictional engagement with an elongated medical instrument. In various embodiments, the one or more gripping surfaces can include one or more of ridges; grooves; coatings; high-frictional material inserts, attachments, overmoldings, etc. (e.g., rubber); and/or any other suitable feature. 
       FIGS. 4A-6C  illustrate an embodiment of the retention member  102  coupled to a handle  170 . The handle  170  is shown to include a body  171 . The body  171  is shown to include a cavity or channel  172 , an insertion path  173 , and a gripping feature  174 . The body  171  is shown to have a generally cylindrical shape with a diameter that is suitable to be grasped by the user&#39;s hand. For example, the diameter of the body  171  may be at least twice a diameter of the elongated body  195  in some embodiments. In other embodiments, the diameter may be 3, 5, 10, or 20 times the diameter the elongated body  195 . In some embodiments, the body  171  may have any other suitable shape, such as square, elliptical, or other geometries are likewise within the scope of this disclosure. The gripping feature  174  may be disposed on an outer surface of the body  171 . As depicted in  FIG. 5 , the gripping feature  174  includes a plurality of transversely oriented discs or ribs disposed at various locations along a length of the body  171 . In other embodiments, the gripping feature  174  can include one or more of ridges; grooves; bumps, recesses, high-frictional coatings; high-frictional material inserts, attachments, overmoldings, of rubber, silicone, thermoplastic elastomer; and/or any other suitable feature. 
     The handle  170  can also be configured such that the elongated device is disposed substantially within a central longitudinal axis of the handle  170 . The length of the handle  170  can vary. In some embodiments, the handle  170  is sized such that it extends from at least a first finger, across a second finger, and to at least a third finger. As the handle  170  is twisted or otherwise moved when in the securing state, the elongated device can also be configured to rotate about an axis that is substantially the same as the longitudinal axis of the elongated device. 
     The cavity  172  is disposed within the body  171 . A proximal portion may be narrow and sized to receive the elongated body  195  while a distal portion may be wider and sized to receive the retention member  102 . The retention member  102  may be coupled to the body  171  using any suitable technique. For example, as illustrated in  FIGS. 4A-4B , the body  171  includes protrusions  178  and the retention member  102  includes recesses  167  configured to receive the protrusions  178  to couple the retention member  102  to the handle  170  within the cavity  172 . The coupling of the protrusions  178  and the recesses  167  can be similar to a ski boot coupling to ski bindings. For instance, the protrusions  178  can extend inwardly such that the recesses  167  are configured to be received by or otherwise mated with the protrusions  178  and retained by the protrusions  178 . The engagement between the protrusions  178  and the recesses  167  can also be described as an interference fit. Other coupling techniques such as bonding, welding, adhesive, fasteners, pins, and any other suitable technique are contemplated within the scope of this disclosure. Alternatively, the body  171  and the retention member  102  may be formed together. 
     The insertion path  173  may extend the length of the cavity  172 . A first end wall  176  may include a vertical notch  180  that is in communication with the insertion path  173 . The notch  180  may include an angled wall that may allow and guide a portion of the elongated body  195  to be disposed within the insertion path  173 . A second end wall  175  of the body  171  may include a horizontal notch  179  sized to receive a portion of the elongated body  195 . The horizontal notch  179  may be at least about 30, about 40, about 50, about 60, about 70, about 80 or about 90 degrees from the vertical notch  180 . The notch  179  may allow the elongated body  195  to be aligned with a central axis of the body  171  when the secondary manipulator device  100  is in the secured state. The insertion path  173  may communicate with the opening  112  of the retention member  102 . For example, in the illustrated embodiment, the handle  170  defines the insertion path  173  along which the elongated medical instrument  190  can be introduced into the channel  110 , as discussed further below. That is, the elongated medical instrument  190  can be advanced along the insertion path  173 , through the opening  112 , and into the channel  110 . 
       FIG. 6A  is a top view of the secondary manipulator device  100  with the retention member  102  in the open state. The insertion path  173  of the handle  170  is shown extending along the length of the cavity  172  from the first end wall  175  to the second end wall  176 . 
       FIG. 6B  is another top view of the secondary manipulator device  100  with the retention member  102  in the open state and of the elongated body  195  disposed within the insertion path  173  and the notch  180 . 
       FIG. 6C  is another top view of the secondary manipulator device  100  in the secured state after a portion of the elongated body  195  has been moved from the insertion path  173  through the opening  112  into the channel  110 . The elongated body  195  may have a natural free state that is substantially linear. When the elongated body  195  is physically manipulated into the channel  110  by bending and turning within the insertion path  173  and then released, the elongated body  195  is substantially constrained in at least two locations along the length of the handle  170 . For instance, the retention member  102  can engage and substantially constrain (or limit movement) of the elongated body  195  at a first location, and the handle  170  can substantially constrain (or limit movement) of the elongated body  195  at a second direction. More specifically, the second end wall  175  of the handle  170  can limit movement of the elongated body  195  in at least three directions (e.g., up, down, or inward) as a result of the configuration of the horizontal notch  179 . The secondary manipulator device  100  can also become fixedly secured to the catheter body and any rotation or translation of the secondary manipulator device  100  will cause the elongated body  195  to move accordingly. When the device is in an open state or a closed state, the elongated member is constrained in the channel by the natural state form of the elongated member and the device can be repositioned along the elongated member longitudinal axis. 
       FIG. 7  is a top view schematic of the elongated medical instrument  190 , wherein a physician, doctor, healthcare worker, user, or operator DR is shown manipulating the elongated medical instrument  190  by a first hand H 1  controlling the primary manipulator device  194  and a second hand H 2  controlling the orientation and position of the secondary manipulator device  100  following securement of the secondary manipulator device  100  to the elongated body  195 . Slack in the elongated body  195  disposed between the primary and secondary manipulator devices  194 ,  100  allows the operator DR to move the second hand H 2  relative to the first hand H 1  to cause the distal portion  193  to axially translate. Also, the operator DR can twist or rotate the second hand H 2  about the longitudinal axis of the elongated body  195  relative to the first hand H 1  and cause the distal portion  193  to rotate while the distal portion  193  is in a shaped configuration caused by the primary manipulator device  194  being controlled by the first hand H 1  of the operator DR. This configuration of using the primary and secondary manipulator devices  194 ,  100  in conjunction with each other allows the operator DR to position the distal portion  193  at a desired location within the patient&#39;s body P for therapeutic or diagnostic purposes. For example, the distal portion  193  can be positioned in a coronary artery or cavity, including the heart atrium or ventricle, by utilizing the primary manipulator device  194  to shape the distal portion  193  and the secondary manipulator device  100  to axially translate and rotate the distal portion  193  during insertion of the elongated medical instrument  190  into the coronary artery. The location of the distal portion  193  can also be controlled for procedures like cardiac ablation and/or cardiac mapping. 
       FIG. 8  depicts an embodiment of a secondary manipulator device  200  according to another embodiment. The secondary manipulator device  200  resembles the secondary manipulator device  100  described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digit incremented to “2.” For example, the embodiment depicted in  FIG. 8  includes a handle  270  that may, in some respects, resemble the handle  170  of  FIG. 1 . Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the handle  170  and related components shown in  FIGS. 1-7  may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the secondary manipulator device  200  and related components depicted in  FIG. 8 . Any suitable combination of the features, and variations of the same, described with respect to the secondary manipulator device  100  and related components illustrated in  FIGS. 1-7  can be employed with the secondary manipulator device  200  and related components of  FIG. 8 , and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented. 
       FIG. 8  is an exploded perspective view of another embodiment of a secondary manipulator device  200  disassembled from an elongated body  295  of an elongated medical instrument  290 . The secondary manipulator device  200  includes a handle  270 . A diameter of the handle DH is at least twice a diameter of the elongated body  295  in some embodiments. In other embodiments, the handle diameter DH is 3, 5, 10, or 20 times the diameter the elongated body  295 . 
     The handle  270  includes handle mating halves  281 ,  282  that can be substantially identical or complementary to one another. The handle mating halves  281 ,  282  include semi-circular channels  286  extending axially along a length of the handle  270 . The channels  286  can form a circular channel when the handle mating halves  281 ,  282  are clamped together. A diameter of the circular channel can be smaller than the diameter of the elongated body  295  such that the elongated body  295  is fixedly secured within the handle  270  to facilitate manipulation of the elongated body  295 . In some embodiments, the channels  286  may include a high-friction surface to increase the securement of the elongated body  295 . For example, the high-friction surface may include one or more of ridges, grooves, bumps, recesses, high-frictional coatings, high-frictional material inserts, attachments, overmoldings of rubber, silicone, or thermoplastic elastomer, and/or any other suitable feature. 
     The handle  270  may include alignment pins  288  configured to be received into alignment holes  289  when the handle mating halves  281 ,  282  are coupled together. The alignment pins  288  and alignment holes  289  allow the channels  286  to align and form the circular channel around the elongated body  295 . The handle  270  may include at least one fastener  283  configured to be threaded into at least one threaded hole  284  to facilitate clamping of the handle mating halves  281 ,  282  together about the elongated body  295 . The handle  270  may be clamped together either before or after the elongated medical instrument  290  is inserted into the patient&#39;s body. 
       FIG. 9  depicts the secondary manipulator device  200  selectively coupled to an intermediate portion  292  of the elongated body  295 . A primary manipulator device  294  is coupled to a proximal portion  291  of the elongated body  295  and is configured to control the shape of the distal portion  293  of the elongated body  295 . For example, the primary manipulator device  294  may include an actuator  296  that can be actuated (e.g., rotated), shown as S IN , to deform the shape of the distal end  297 , shown as S OUT . In certain embodiments, the actuator  296  can be actuated to bend or otherwise turn the distal end  297  of the elongated body  295 . At the user&#39;s discretion, the secondary manipulator  200  can be manipulated to further control the distal portion  293  of the elongated body  295 . For instance, the secondary manipulator  200  can be manipulated to control a rotation and/or axial translation of the distal end  297 , which may be disposed inside a patient. 
     With continued reference to  FIG. 9 , the secondary manipulator device  200  can be axially translated, shown as T′IN, relative to the primary manipulator device  294 . Axial translation of the secondary manipulator device  200  (T′IN) can result in axial translation of the distal portion  293  of the elongated body  295 , shown as TOUT. The secondary manipulator  200  can also be rotated, shown as R′IN, about a longitudinal axis of the elongated body  295 . Rotation of the secondary manipulator device  200  (R′IN) can result in rotation of the distal portion  293  of the elongated body  295 , shown as ROUT. 
       FIG. 10  is a perspective cross-sectional view of another secondary manipulator device  300 . As depicted, the secondary manipulator device  300  includes a knob handle  367  having an external thread  368  and a conical receiving portion  369  disposed at one end. A gripper handle  337  is coupled to an end of the knob handle  367 . The gripper handle  337  includes an internal thread  338  configured to threading engage with the external thread portion  368 . A ferrule  315  with fingers  316  is disposed within the conical receiving portion  369 . A channel  318  extends through the knob handle  367  and the gripper handle  337 . When the knob handle  367  is rotated one direction, the threads  338 ,  368  interact and cause the fingers  316  to engage with the conical receiving portion  369  and deflect inwardly. The fingers  316  can engage an elongated body (not shown) positioned through the channel  318 . When the knob handle  367  is rotated an opposite direction, the fingers  316  retract radially away from the channel  318  and the elongated body. 
       FIG. 11  depicts the secondary manipulator device  300  selectively coupled to an intermediate portion  392  of the elongated body  395 . A primary manipulator device  394  is coupled to a proximal portion  391  of the elongated body  395  and is configured to control the shape of the distal portion  393  of the elongated body  395 . For example, the primary manipulator device  394  may include an actuator  396  that can be actuated (e.g., rotated), shown as S IN , to deform the shape of the distal end  397 , shown as S OUT . In certain embodiments, the actuator  396  can be actuated to bend or otherwise turn the distal end  397  of the elongated body  395 . At the user&#39;s discretion, the secondary manipulator  300  can be manipulated to further control the distal portion  393  of the elongated body  395 . For instance, the secondary manipulator  300  can be manipulated to control a rotation and/or axial translation of the distal end  397 , which may be disposed inside a patient. 
     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.