Patent Publication Number: US-11019985-B2

Title: Medical tools and related methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a continuation application of pending U.S. Nonprovisional application Ser. No. 14/177,960, filed on Feb. 11, 2014, which claims the priority benefit of U.S. Provisional Application No. 61/764,764, filed on Feb. 14, 2013, the entireties of which are incorporated by reference herein. 
    
    
     FIELD OF THE DISCLOSURE 
     Embodiments of the present disclosure relate generally to medical devices suitable for use in medical procedures. In particular, embodiments of the instant disclosure relate to a docking station or stabilizing system for medical devices. 
     BACKGROUND 
     In the medical field, introduction sheaths, such as, e.g., endoscopes, are now widely used for diagnostic or therapeutic procedures of various diseases. Endoscopes generally take the form of a long, flexible tube, including a light conductor along with one or more channels for inserting various medical instruments. Typically, the endoscope is inserted into a patient&#39;s body through an incision or natural orifice. Within the body, these instruments allow for minimally invasive surgery, providing platforms for employing numerous tools, such as devices to grasp, clip, sever, and/or remove objects from inside the body, as well as devices to illuminate and view the surgical field. 
     Accurately positioning the tip of an endoscope at a precise location within a patient&#39;s body can pose a problem. Conventional instruments require considerable effort from large muscle groups such as wrists, elbows, and arms, and the manual effort required for moving the instruments from one site to another can be a factor during a given procedure. Moreover, the length and size of conventional equipment increases the complexity of the entire system. Indeed, two operators are often required; one for managing one Degree of Freedom (DoF) that defines various instruments&#39; movements such as in/out, rotation, while another manages the endoscope and shaft of the tool. Additionally, the endoscopes are not capable of providing an angled approach or divergence to the instruments to direct the instrument toward a particular area inside the body. The existing systems do not allow physicians to manipulate the instruments inside the patient&#39;s body without a significant physical effort on the physician&#39;s part. Thus, a system that significantly reduces the physician&#39;s physical effort during a medical procedure is desirable. 
     SUMMARY 
     Embodiments of the present disclosure are directed towards a system for introducing finger controlled instruments into a patient&#39;s body. 
     A medical system may include an elongate member having a proximal end, a distal end, one or more channels extending between the proximal end and the distal end, and a handle operably coupled to the proximal end. The handle may include one or more ports in communication with the one or more channels. The medical system may further include a docking station supporting the proximal end of the elongate member. The docking station may include a receiver adapted to receive and secure the handle and an adaptor guide unit having a distal end, a proximal end, and one or more passages formed therethrough, the one or more passages communicating with the one or more channels. 
     Various embodiments of the medical system may include one or more of the following features: a support structure for securing the docking station to a location adjacent a patient; one or more medical instruments may be introduced through the passages and into the elongate member; the medical instruments may be operated by a small muscle group of a user; the adaptor guide unit may include two passages disposed at an angle relative to one another; the two passages of the adaptor guide unit may be in communication with two ports on the handle of the elongate member; the medical instruments may be configured to be operated by fingers of a user; the elongate member may be an endoscope; each of the medical instruments may include an end-effector, and the fingers of a user may control one of a position of the end-effector and a configuration of the end-effector; and each of the medical instruments may be steerable independently of the elongate member. 
     In another embodiment, a stabilizing system for controlling medical instruments positioned inside the body of a patient may include a docking station supporting a proximal end of an elongate member. The docking station may include a receiver adapted to receive and secure a handle portion of the elongate member, a adaptor guide unit having a distal end, a proximal end, and one or more passages formed lengthwise therethrough, and a securing mechanism configured to secure the docking station at a position adjacent the patient. 
     Various embodiments of the stabilizing system may include one or more of the following features: the elongate member may include a plurality of working channels in communication with the one or more passages formed in the adaptor guide unit; at least one medical instrument may be disposed in one of the plurality of channels; the at least one medical instrument may include an end-effector, and the fingers of a user control one of a position of the end-effector and a configuration of the end-effector; the elongate member may include a handle having at least one port in communication with at least one of the passages formed in the adaptor guide unit; the at least one medical instrument may be steerable independently of the elongate member; the at least one medical device may be configured to be operated by fingers of a user; the adaptor guide unit may include two passages disposed at an angle relative to one another. 
     In another embodiment, a method for operating a medical device may include securing a handle of an endoscope in a docking station, wherein the endoscope includes a plurality of working channels, wherein the docking station comprises a adaptor guide unit having passages in communication with the working channels, and wherein the docking station is secured to a position adjacent a user. The method may also include introducing one or more medical devices into the passages and working channels, wherein the one or more medical devices include medical devices configured for operation by fingers of a user. The method may further include performing a medical procedure by manipulating the one or more medical devices. In some embodiments, the adaptor guide unit may include two passages disposed at an angle relative to one another. 
     It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the disclosure, as claimed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the present disclosure and together with the description, serve to explain the principles of the disclosure. 
         FIG. 1  is a perspective view of an overall system, according to embodiments of the present disclosure. 
         FIG. 2  is a detail plan view of an adaptor guide unit for use with the system of  FIG. 1   
         FIG. 3  is a detail pictorial view of a leg member clamp mechanism. 
         FIGS. 4A and 4B  depict an end-effector (embodied here as a grasper) and a control handle, respectively, for use with the system of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The term “distal” refers to the end farthest away from a medical professional when introducing a device in a patient. By contrast, “proximal” refers to the end closest to the medical professional when placing a device in the patient. 
     Overview 
     Embodiments of the present disclosure relate to medical devices used to introduce and manipulate instruments employed in minimally-invasive surgery, typically involving an endoscope or other suitable introduction sheath. More particularly, embodiments of the disclosure provide a stabilizing system for maintaining the proximal end of an endoscope in a steady, stable position during a surgical procedure. Thus, the medical devices are more accurately manipulated with less energy being expended by the operator or physician. The stabilizing system further allows the operator to manipulate instruments more precisely and with less effort, using small muscle groups such as in the fingers and hands. Thus, instruments that may be operated with small muscle groups reduce stress, and allow for a smaller and lighter design that can be manufactured at lower cost. The stabilizing system broadly comprises an elongate introduction sheath, such as an endoscope, secured in a stable position by a docking station. The elongate introduction sheath includes a handle and one or more working channels, accessible via ports in the handle. The docking station generally includes a receiver, adapted to receive and secure the elongate member handle; a adaptor guide unit, which facilitates introduction of medical devices into working channels of the elongate members, through passages formed in the adaptor guide unit; and a leg member, which clamps the docking station to an object (e.g., a patient&#39;s bed), to fixedly secure the docket station proximate the patient. 
       FIG. 1  illustrates an exemplary stabilizing system  100  according to embodiments of the present disclosure. The stabilizing system  100  includes an elongate member  102 , which can be a conventional endoscope or endoscopic device, having a proximal end  104 , a distal end (not shown), and one or more channels (not shown) extending between the proximal end  104  and the distal end (not shown). As will be appreciated from the discussion below, elongate member  102  may be a double-channel endoscope. The elongate member  102  also includes a handle  103 . The handle  103  can provide, for example, control knobs  101  for manipulating the distal tip of the elongate member  102  during insertion into a patient. Handle  103  may include one or more ports  107 , which provide ready access to the channels of the elongate member  102 . One port may be provided for each available channel in the elongate member  102 . Alternatively, a single port may provide access to all of the channels within the elongate member  102 . Various embodiments of the present disclosure may employ various forms of endoscopic devices, adapted for particular surgical procedures. For example, a procedure involving the small intestine may call for a duodenoscope. Those of skill in the art will recognize that other suitable endoscopic instruments may be used, as needed. Such instruments may be selected in needed configurations, diameters, or shapes. Medical devices to be employed in using embodiments of the present disclosure are discussed in more detail below. 
     The stabilizing system  100  may further include a docking station  105  that secures the elongate member  102  in a stable position adjacent the patient. The docking station  105  includes a receiver  108  that receives and secures the elongate member handle  103 , an adaptor guide unit  112 , and a leg member  110 . As explained below, the adaptor guide unit  112  facilitates insertion of medical devices into the elongate member working channels, and the leg member  110  supports the receiver  108  and secures it to a stationary object, such as, e.g., a patient&#39;s bed. 
     The elongate member  102  may comprise an endoscope, for example, and may carry any number of medical instruments via the proximal end  104  of the elongate member  102 , to a location within a patient&#39;s body for surgery, treatment, and/or diagnosis. The elongate member  102  may be of any suitable length, such as, but not limited to, 100 cm, 160 cm, or 240 cm. The elongate member  102  may further include an end-effector (as shown in, e.g.,  FIG. 4A ) extending distally therefrom. Other exemplary tools that may be carried at the distal tip of elongate member  102  may include a light source, a camera or other suitable imaging devices, and other devices for visualizing the surgical field. The elongate member  102  may include one or more channels for inserting medical instruments. The medical instruments may allow the physician to perform fine tissue manipulation using small muscle groups, such as muscles in the fingers and/or thumb. The medical instruments may be steerable independently of elongate member  102 . 
     According to an embodiment, different medical instruments may be inserted into different endoscope channels. For example, an operator may place a cutting tool in one channel, and a retraction tool in another channel. It is understood that other exemplary instruments may be inserted in the working channels without departing from the scope of the present disclosure. Some channels may have a larger diameter, while others may have a smaller diameter. Further, some channels may include permanently fixed devices, such as light sources or cameras, while other channels may allow temporary insertion of medical instruments, as the operator may desire. Various examples of medical instruments that may be resident in any one of the channels include, but are not limited to, suction pumps, cauterization instruments, graspers, clippers, lasers, baskets, lithotripters, forceps, biopsy devices, tissue removal instruments, and tissue cutting instruments. These medical instruments may allow operators/physicians to perform procedures within the patient&#39;s body. In one example, the medical instruments may extend beyond the working channel of the elongate member  102 , e.g., be about 8 inches longer than the working channel, depending on the particular medical procedure. Alternatively, the length of the medical instruments may vary based on the configuration of the elongate member  102 . 
     Receiver  108  is adapted to receive and secure handle  103  of elongate member  102 . It will be understood, therefore, that the exact configuration of receiver  108  may depend on the configuration of the handle  103  employed in a particular application. The following discussion provides sufficient information for those in the art to configure a receiver  108  for a given circumstance. The illustrated embodiment in  FIG. 1  includes a receiver flange  109 , which may be a channel-shaped device dimensioned to receive a portion of handle  103 , and a fastening means (not shown) for fixing the handle  103  in position. The channel may be formed in, e.g., a U-shaped or L-shaped form, or other suitable form as desired, receiving the handle  103  on its flat bottom and securing the handle  103  against at least one upright side portion. The fastening means can be any suitable fastener, such as a set screw, spring mount or the like, having sufficient retentive capability to resist the forces likely to be applied to the handle  103 . The receiver  108  may be formed from a material suitable for a surgical environment, such as stainless steel or a polymer material. 
     Adaptor guide unit  112  is a generally plate-like device, positioned in abutment with the ports  107  and extending generally at a shallow angle to and away from handle  103 . Adaptor guide unit  112  extends the angle of the introduction port (not shown) of the elongate member  102  to provide enough space on the proximal end  104 . Thus, the adaptor guide unit  112  may help in elongating medical tools interface with working channels of the elongate member  102 . As shown in detail in  FIG. 2 , the adaptor guide unit  112  may take the form of a trapezoid, its distal end  112 ( a ) being generally more narrow end than proximal end  112 ( b ). Adaptor guide unit  112  can be fixed to the receiver  108 , integral with docking station  105 , dimensioned and positioned so that the handle  103  slides into receiver flange  109  until the ports  107  fit against the adaptor guide unit distal end  112 ( a ), at which time the handle  103  is fixed in position within receiver flange  109 . Alternatively, adaptor guide unit  112  may be mounted directly on handle  103 , employing a suitable mounting structure. The desirability of a trapezoidal form for adaptor guide unit  112  will be explained more fully below. Alternative shapes may be selected for adaptor guide unit  112 , in keeping with particular requirements for a given application. 
     With continuing reference to  FIG. 2 , passages or channel extensions  120 ( a ) and  120 ( b ) run lengthwise through adaptor guide unit  112 , from its distal end  112 ( a ) to its proximal end  112 ( b ). These passages may be sized generally similarly or identically to the ports  107 , designed to pass a medical device from the adaptor guide unit proximal end  112 ( b ), through the adaptor guide unit  112 , into ports  107 , and then into the working channels of the elongate member  102 . Passages  120 ( a ) and  120 ( b ) run generally parallel to the sides of adaptor guide unit  112 , so that the proximal ends of the channels are spaced farther apart than are the distal ends. In practice, the spacing and alignment of the passages  120  can be adjusted as desired. In one embodiment, for example, the passages  120 ( a ) and  120 ( b ) may be located as little as 1 inch distant from the point of entry (introduction port) of the elongate member  102 . The cross-sectional diameter of the passages  120 ( a ) and  120 ( b ) may maintain minimal bearing diameter that does not exceed the working channel diameter of the elongate member  102 . The passages  120 ( a ) and  120 ( b ) may have a divergence configuration that allows forces to be applied downwardly to the medical instruments. Advantages of the embodiment depicted in  FIG. 2  will be set out more fully, below. 
     The medical systems and stabilizing systems presently disclosed may comprise biocompatible materials. For example, the passages and/or channels may be made from a variety of suitable biocompatible materials such as nitinol, stainless steel, or polyimide. The chosen material may be based on desired stiffness, resilience, and/or other properties, as will be understood to those skilled in the art. The passages and/or channels may be coated with a suitable friction reducing material such as, e.g., TEFLON®, polyetheretherketone, polyimide, nylon, polyethylene, or other lubricious polymer coatings. Such coatings may, for example, reduce surface friction with the surrounding tissues. 
     Referring to  FIG. 1 , receiver  108  is supported by leg member  110 , extending downward from the bottom of receiver flange  109 . The receiver  108  is joined to the leg member  110  by mounting attachment  124 , which may provide one or more degrees of freedom for adjusting the alignment and position of the docking station  105 . First, mounting attachment  124  may rotate, allowing receiver  108  to rotate in a horizontal plane. Also, or alternatively, mounting attachment  124  may pivot about an axis perpendicular to leg member  110 , allowing the distal end of handle  103  to pivot up or down, as desired. Finally, attachment  124  may be provided with a sliding extension, allowing the docking station  105  to be shifted up and down. Mounting attachment  124  may also be fitted with a locking device, so that each of the adjustments may be fixed in place. A person of ordinary skill in the art will recognize further variations of attachment  124  suitable for the present disclosure. 
     Leg member  110  includes a clamp mechanism  121 , fixed to the end of leg member  110  and clamped to a suitable object  302  as shown in  FIG. 3 . It will be understood that any suitable clamping or attachment mechanisms may be employed according to a particular application. The clamp shown in the illustrated embodiment includes side extensions  306 , chosen to fit around a desired object  302  (such as, e.g., a portion of the patient&#39;s bed), and a set screw arrangement  304 , adapted to fix the clamping mechanism to the object  302 . It will be understood that object  302  should be chosen with a view to sufficiently support docking station  105 , elongate member  102 , and/or any associated medical devices as set out below. A portion of a table, or a table leg, might comprise suitable objects, for example. 
       FIG. 1  shows the stabilization system  100  of the present disclosure in use. Prior to use, docking station  105  is mounted, with a clamp mechanism  121  securely attached to an object  302  (as shown in, e.g.,  FIG. 3 ). Also, the adjustable settings of adjustment mechanism will be positioned as desired to most effectively position elongate member  102  with respect to the patient. Then, elongate member  102  may be slid into place on receiver flange  109  and also fixed in place. When ready, the distal end of elongate member  102  is inserted into a patient, and its distal tip maneuvered to the surgical site within the patient. 
     At that point, medical devices such as devices  115 ( a ) and  115 ( b ) may be employed as shown in  FIG. 1 . In one embodiment, for example, the medical devices  115 ( a ) and/or  115 ( b ) may be limited to sweep in one plane. The illustrated devices  115 ( a ) and  115 ( b ) may be similar to endoscopic medical devices and suitable for employment within working channels of an endoscope. As shown, each medical device  115 ( a ) and  115 ( b ) includes its own control handle  116 ( a ) and  116 ( b ), respectively, and elongated portion (such as, e.g., an elongated shaft) extending therefrom. Each device is employed by inserting its distal tip the into a channel extension  120 ( a ) or  120 ( b ), through the adaptor guide unit  112 , and into the ports  107 , onward through a working channel of the elongated member  102 , exiting from that member at the surgical site. A single medical device may be employed, or the number of medical devices may be increased up to the number of available working channels of the elongate member  102 , ports  107 , and channel extensions, e.g.,  120 ( a ) and  120 ( b ). In addition, in some embodiments, a plurality of medical devices may be deployed in a single working channel. In some scenarios, the stabilizing system  100  enhances the functionality of medical devices  115 ( a ) and  115 ( b ) for positioning within the body. 
     The distal tip of each medical device  115 ( a ) and  115 ( b ) may include any suitable endoscopic end-effectors to a given treatment site in the patient. An example of a suitable medical device is the tissue grasper  400  shown in  FIG. 4A , which depicts grasper  400  in an open configuration. The tissue grasper  400  may be passed through a lumen of the elongated member  102 , and it includes an end-effector  401  extending distally from a flexible shaft  408 , which may be disposed within the elongated member  102 . The flexible shaft  408  may include an actuation member or control member (not shown) therein. The control member extends through the flexible shaft  408  translating the movements from a controller or handle  116  present at the proximal end  104  (see, e.g.,  FIG. 1 ) of the flexible shaft  408 . The flexible shaft  408  may also include a clevis member  407  or other suitable fastener system that is present at its distal end. 
     The end-effector  401  includes two jaws or arms, an upper arm  402   b  and a lower arm  402   a , (hereafter, arms  402 ) pivotally connected to each other. The arms  402  may be pivotably coupled to the clevis  404  of clevis member  407  via a pivot pin. A proximal end  406  of arms  402  may be rotatably connected to flexible shaft  408  at a pivot point to permit arms  402  to rotate about the pivot as shown in  FIG. 4 a   . A control member (not shown) may be operably connected to the proximal end  406  of one or both of arms  402 , so that actuating the arms  402  at their proximal end  406  translates into movement of the arms  402  at their distal end. While both arms  402  may be pivotable relative to one another, in some embodiments, one of the arms (e.g.,  402   a ) may be fixed, and the other arm (e.g.,  402   b ) be movable, so the control member actuates only the movable arm ( 402   b ). Once the one or more end-effectors are in position at the surgical site, the operator can control the end-effectors by exerting a minimum of force. 
     In one embodiment, the devices used with stabilizing system  100  may include one or more control handles, e.g.,  116 ( a ) and  116 ( b ). The control handles  116  as shown in  FIG. 4B  belong to tools inserted through the channels  120 ( a ) and  120 ( b ), respectively, and into the elongate member  102 , thus, facilitating fine manipulation of the tools inside the body. Small muscle groups such as muscles of the fingers, thumb, and/or wrists, may be used to operate the control handle  116 , which also may be extended through the channel extensions  120 ( a ) and  120 ( b ) shown in  FIG. 2 . The control handle  116  may include a mechanism for articulating or actuating a surgical tool at the distal end of the flexible shaft  408 . The mechanism may include one or more buttons, triggers, or any other mechanisms suitable for manipulating the tools inside the body. According to an embodiment, the buttons, triggers or other mechanisms may provide one or more Degrees of Freedom (DoF) including, but not limited to, longitudinal movement (e.g., in/out), rotation, one-directional steering, and open/close. 
       FIGS. 4A and 4B  depict the interaction between control handle  116  and the end-effector  401 . A thumb-actuated lever  410  may be placed on the control handle  116 . As shown, the forces exerted in pulling proximally (1) or pushing distally (2) move the grasper  400  upward or downward, respectively. Moreover, the control handle  116  may include a trigger  412  that may be used for performing actions such as closing or opening the grasper  400 . The trigger  412  may perform the desired action via a single finger or the thumb. For example, pulling the trigger  412  (in direction of arrow ( 3 )) may close the end-effector, e.g., grasper  401 . Opening the grasper  401  may be performed by releasing the trigger  412  (in direction of arrow ( 4 )). 
     From the description in connection with  FIGS. 4A and 4B , together with consideration of  FIG. 1 , showing simultaneous operation of medical devices  115 ( a ) and  115 ( b ), it will be appreciated that providing extension channels  120 ( a ) and  120 ( b ) in a divergent configuration—that is, having their proximal ends spaced wider than their distal ends—may offer considerable advantage in operation, allowing the operator greater freedom in handling and moving the respective control handles  116 ( a ) and  116 ( b ). 
     The stabilizing systems disclosed herein may be used with single and/or multi-working channel scopes, including endoscopes that are commercially available. 
     The medical system of the present disclosure may provide simple, finger controlled medical instruments, thus downsizing and/or simplifying the supporting structure for the instruments. Accordingly, the system may reduce loads to be applied to the instruments, e.g., the amount of force that must be supplied to control the instruments, require less stabilization of the docking station, allow for use of more delicate instruments, and eliminate or decrease the complexity of rails and bearings. 
     Those skilled in the art will recognize that the present disclosure may be manifested in a variety of forms other than the specific embodiments described herein. Accordingly, departure in form and/or detail may be made without departing from the scope and spirit of the present disclosure as described in the appended claims.