Patent Publication Number: US-2022225863-A1

Title: Endoscopic sheath holding tip and stabilization system

Description:
BACKGROUND 
     Technical Field 
     The present invention relates to the use of a scope such as a cystoscope or endoscope. More particularly, it relates to a device for holding, securing and stabilizing a scope sheath in place during a surgical procedure. 
     Description of the Prior Art 
     By way of example, when a urologist operates on a patient in the dorsal lithotomy position, they must share the narrowed space between the patient&#39;s legs or place the assist in an ergonomically challenging position of holding the cystoscope sheath over the patient&#39;s leg, all while holding the cystoscope sheath in the correct, static position while trying to hand the surgeon wires, stents, syringes, or other devices. For difficult anatomy (e.g., large median prostatic lobes, severely trabeculated bladders, bleeding etc.), it may require the surgeon to manipulate a wire (instrument or device) with two hands yet maintain visualization of the ureteral orifice. 
     What is less apparent or less discussed, is how stressful it can be for the scrub to assist the surgeon during these types of procedures, especially in difficult, long cases or when they have minimal experience with urological procedures. 
     Radiation exposure is another concern. The urologist&#39;s hands that hold the cystoscope sheath are more prone to exposure of harmful radiation during fluoroscopic imaging. The doctor&#39;s assistant is also at risk for radiation exposure when holding the cystoscope sheath. Since radiation exposure reduces exponentially when moving away from the same, a foot or two can make a substantial difference in what the operating room personnel is exposed to as a result. 
     It is therefore desirable to remove the need for a scrub nurse or doctor or anyone in the operating room to hold the cystoscope sheath during the performance of surgical procedures. 
     SUMMARY OF THE INVENTION 
     This and other aspects of the invention are achieved by an endoscopic sheath holding tip and stabilization system that includes a table mounted flexible or rigid arm engaging portion configured securely attach the stabilization system to a table mounted flexible or rigid arm. An a scope sheath engaging portion configured to engage a scope sheath from an underside thereof and an upper surface thereof to secure the scope sheath from any movement once positioned in the scope sheath engaging portion. 
     According to another embodiment, the scope sheath stabilization system includes a table mounted flexible or rigid arm engaging portion configured to securely attach the scope sheath and holding tip to the table mounted flexible or rigid arm, and a scope sheath engaging portion configured to engage and secure the scope sheath from any movement once positioned in the scope sheath engaging portion. 
     In one embodiment, the scope sheath engaging portion includes an inverted U shape device having a top portion connected to the table mounted flexible or rigid arm engaging portion and two downward extending legs. Each leg has a hook positioned at a bottom thereof configured to be positioned under and engage an underside of the scope sheath. A plunger mechanism extending downward from the top portion engages the upper surface of the scope sheath. 
     Other aspects and features of the present principles will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the present principles, for which reference should be made to the appended claims. It should be further understood that the drawings are not necessarily drawn to scale and that, unless otherwise indicated, they are merely intended to conceptually illustrate the structures and procedures described herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings wherein like reference numerals denote similar components throughout the views: 
         FIGS. 1A-1E  show various views of the endoscopic sheath holding tip and stabilization system according to an embodiment of the invention; 
         FIG. 1F  is an exploded view of the scope sheath and holding tip stabilization system according to an embodiment of the invention; 
         FIG. 2A  shows a side view of an exemplary table mounted flexible or rigid arm to which the scope sheath and holding tip stabilization system is attached according to an embodiment of the invention; 
         FIG. 2B  is a cross-sectional view of the exemplary table mounted flexible or rigid arm of  FIG. 2A , taken along lines A-A thereof; 
         FIG. 3A  shows a dissembled view of the scope sheath and holding tip stabilization system with an exemplary table mounted flexible or rigid arm according to an embodiment of the invention; 
         FIG. 3B  shows an assembled view of the scope sheath and holding tip stabilization system with an exemplary table mounted flexible or rigid arm according to an embodiment of the invention; 
         FIGS. 4A and 4B  show a top view and rear perspective view, respectively, of a cystoscope sheath according to an embodiment of the invention; 
         FIG. 4C  is a perspective view of scope sheath and holding tip stabilization system with cystoscope sheath positioned/stabilized therein, according to an embodiment of the invention; 
         FIGS. 5A and 5B  show close of perspective views of the engagement of the scope sheath and holding tip stabilization system with a scope sheath according to the yet another embodiment of the invention; 
         FIGS. 6A and 6B  show an alternative connection method between the table mounted flexible or rigid arm and the scope sheath and holding tip stabilization system according to another embodiment of the invention; 
         FIGS. 7A and 7B  show another connection method between the table mounted flexible or rigid arm and the scope sheath and holding tip stabilization system according to yet another embodiment of the invention; 
         FIGS. 8A and 8B  show another connection method between the table mounted flexible or rigid arm and the scope sheath and holding tip stabilization system according to a further embodiment of the invention; 
         FIGS. 9A and 9B  show another connection method between the table mounted flexible or rigid arm and the scope sheath and holding tip stabilization system according to yet another embodiment of the invention; and 
         FIGS. 10A and 10B  show an alternative implementation where the table mounted flexible or rigid arm is dedicated for use with an integrated scope sheath and holding tip stabilization system according to another embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIGS. 1A-1F , there is shown the endoscopic sheath holding tip and stabilization system  10  (hereinafter referred to as the “sheath holder”  10 ) according to an embodiment of the invention. In this embodiment, the sheath holder  10  includes a sheath engaging portion  20  which include a sheath engaging plunger assembly  16 ,  18 ,  19 , and a table mounted flexible or rigid arm connection portion consisting of a shaft  12  that (as will be described in further detail below) houses the shaft  16  of the sheath engaging plunger assembly. At a top end of shaft  12  is a safety knob  14  that operates to serve as a safety measure to ensure the sheath holder does not fall completely out of the flexible or rigid arm if not secured properly. In this embodiment, the sheath engaging portion  20  has a generally upside down or inverted U shape with a central upper portion  25 , and two downwardly extending legs  24 A and  24 B. At the bottom of each leg  24 A and  24 B is a hook  26 A and  26 B, respectively, that is configured to engage and hold onto the scope sheath inflow and outflow ports. 
     At the base of the shaft  12  of table mounted flexible or rigid arm connection portion are included one or more connection points  22  that are configured to receive screws  23  which pass through holes  21  in the sheath engaging portion  20  (see  FIG. 1F ). In this manner, the bottom of shaft  12  is connected to the central upper portion  25  of the sheath engaging portion  20  as shown. Within the shaft  12  is positioned a slidable and spring biased plunger  16  having a foot  18  and which foot  18  includes a beveled or curved surface  19 . The beveled or curved surface  19  of foot  18  can take many different shapes/forms to ensure its engagement with the upper surface of the sheath is secure from any movement once so engaged. For example, an inverted V-shape has proven to work very well when engaging cylindrical sheath shapes as that shown. Those of skill in the art will appreciate that variations in the shape of foot  19  can be made without departing from the intended scope of the invention. Plunger  16  with foot  18  is preferably spring biased downward. 
     In accordance with other embodiments, the plunger  16  could be manually locked into place once the foot  18  is positioned against the upper surface of the sheath. Any suitable locking mechanism could be used, including, for example, a transverse locking screw passing through the shaft  12  and engaging an internal side of the plunger  16 . Another example could include a one direction or one-way ratcheting mechanism with a release, such that when the plunger  16  would be pressed downward against the sheath, a ratcheting mechanism inside the shaft  12  would include teeth that a ratchet pawl on the plunger would engage and lock into at each downward increment until locked against the sheath surface. A ratchet pawl release would allow for removal of the plunger against the sheath. 
     According to one preferred implementation, the table mounted flexible arm or rigid arm connection portion (e.g., the shaft  12 ) is made of surgical steel. The sheath engaging portion  20  is also preferably made from surgical steel. In other applications or uses, the material the device of the present invention can be made from could also include one or more of titanium, aluminum and/or plastics of various types. 
       FIGS. 2A and 2B  show an example of a table mounted flexible arm  30  having an end  32  that includes a hole or aperture  34  therein. A securing knob  36  has a shaft  38  with an end  39  that is in communication with the aperture  34  such that tightening of the securing knob causes the end  39  to engage shaft  12  of the sheath holder  10  such that the correct orientation/depth and positioning of the scope sheath (and thereby the scope) can be securely maintained. 
     Those of skill in the art will appreciate that a table mounted flexible or rigid arm system as described herein is common to a vast array of surgical procedures. These table mounted systems are anchored to a bar or rail that is mounted on the side of the operating table. This bar or rail is commonly used for these types of systems. It is further contemplated herein that the stabilization system for cystoscopy as disclosed herein could have its own dedicated flexible or rigid arm that connects directly to bar or rail on the operating table and can be independent of other table mounted stabilization systems. 
       FIGS. 3A and 3B  show an example of how the shaft  12  engages the aperture  34  of the table mounted flexible arm  30  and is secured in place as described above with reference to  FIG. 2 . 
     Referring to  FIGS. 4A-4C , there is shown a cystoscope sheath  40  having inflow and outflow ports  42 , and an upper surface  44 . Although shown in  FIG. 4C ,  FIGS. 5A and 5B  show enlarged views of how the sheath holder  10  engages and secures to the sheath  40 . As shown, the sheath  40  is positioned between the two downwardly extending legs  24 A and  24 B such that the plunger  16  is pushed upward against its spring bias. The foot  18  with beveled or curved surface  19  engages the upper surface  44  of the sheath. The hooks  26 A and  26 B hook underneath the inflow and outflow ports  42  as shown. 
     As will be appreciated from the present disclosure, the spring biased plunger  16  places a downward force on the sheath  40  pressing the same against the stationary hooks  26 A and  26 B, and thereby operates to completely stabilize the sheath  40 . Once stabilized, the position of the sheath  40  is now completely adjustable and capable of being secured in any desired position through the sheath holder as connected to the table mounted flexible arm  30  through shaft  12  and securing knob  36 . This now allows for the introduction of the cystoscope (not shown) into the sheath  40  and completely eliminates the need for any personnel to hold or otherwise manually maintain the position of the scope during a surgical procedure. 
     In accordance with another embodiment, an adjustable ring clamp (not shown) can replace the plunger  16  and hooks  26  as the sheath engaging portion. The ring claim would be configured to fit around the opening  41  of the sheath (see  FIGS. 4A and 4B ) and locked there around. The ring clamp would be configured to be connected to the table mounted flexible or rigid arm connecting portion in any suitably known manner. 
     In other embodiments, the configuration of the two hooks  26  and legs  24  could change. For example, rather than hooks  26 , the end of legs  24  could converge or be connected together with a cradle like structure configured to be positioned under the opening of the sheath and provide the same upward support that is countered by downward force applied by the plunger mechanism or other upper surface support. 
     In further embodiments of the invention, the manner in which the sheath holder  10  is connected to the table mounted flexible or rigid arm can be modified without departing from the intended scope and spirit of the invention. By way of example,  FIGS. 6A and 6B  show a quick grip attachment system  60  positioned at the end of table mounted flexible arm  30 . The quick grip attachment system  60  includes a channel or slot  62  configured to receive the shaft  12 , and a locking handle  64 , that when closed ( FIG. 6B ) compressed against and secure the shaft  12  in an unmovable fashion in the channel  62 . 
       FIGS. 7A and 7B  show an anvil attachment style connection mechanism  70  for connecting the sheath holder  10  to the table mounted flexible arm  30  via shaft  12 . Here, the connection mechanism includes an opening  72  to receive the shaft  12 , and a sliding collar  74  that locks into place with a rotating collar or knob  76 . The rotating collar or knob  76  is rotated and translates (via threads not shown) to push and tighten down sliding collar  74  against the shaft  12 . In one embodiment a V-shaped feature is included on the rotating collar  74 . 
       FIGS. 8A and 8B  show another anvil attachment style connection mechanism  80  for connecting the sheath holder  10  to the table mounted flexible arm  30  via shaft  12 . This connection mechanism includes base  82  that is positioned at the end of the table mounted flexible arm and which includes a receiving channel  84  positioned transverse thereto. A locking knob  86  is internally threaded such that when the shaft  12  is positioned in the receiving channel  84 , it can be locked into place using the knob  86  operating like a screw clamp onto the shaft while contained in the channel  84 . In accordance with other embodiments, the shaft  12  can include a notch or groove (e.g., V-shaped) that is configured to be engaged by the end of the threaded member controlled by knob  86 , which would have a complimentary shape to the notch or groove. 
       FIGS. 9A and 9B  show another connection mechanism  90  that is a quick connect connection mechanism. In this embodiment, a quick connect collar  92  is positioned on the end of the table mounted flexible arm  30  and has a receiving aperture  93 . A connector  94  that is geometrically sized and shaped to fit into receiving aperture  93  is positioned off the back of the sheath holder  10  such that insertion of the connector  94  into the aperture  93  (and with actuation of the collar  92 ) locks/secures the sheath holder  10  into the end of the flexible arm. 
       FIGS. 10A and 10B  show an alternative embodiment of the sheath holder  10  according to yet another embodiment of the invention. In this embodiment, the table mounted flexible or rigid arm engaging portion and the sheath engaging portion  120  are one in the same and is configured to be fastened directly to an end  32  of the table mounted flexible arm  30  with screws  122 , and includes legs  124 A and  124 B, with hooks  126 A and  126 B respectively. The plunger assembly includes a shaft  116  with a spring  117  positioned around the same. At the bottom of the plunger shaft  116  is the foot  118  with the beveled or curved surface  119 . A hole  36  is provided at the top of the flexible arm to allow the shaft  16  to pass therethrough when pushed upward against the downward spring bias. This embodiment is an example of a dedicated tip style for a flexible or rigid arm. 
     The above invention has been described in the context of cystoscopy and the use of a cystoscope, however, it is to be appreciated that the concepts and novel structures shown and described herein can be applied to other types of procedures and/or scope/scope sheath configurations. By way of one example, hysteroscopy could be another context within which the concepts and principles of the present invention apply to the scope sheath used for the same. Endoscopy can also be another context for the present invention. The continued intended purpose to stabilize the scope sheath for use by the operating room personnel in such that safety and accuracy can be maintained at all time. 
     It should also be understood that the example embodiments disclosed and taught herein are susceptible to numerous and various modifications and alternative forms. Thus, the use of a singular term, such as, but not limited to, “a” and the like, is not intended as limiting of the number of items. Furthermore, the naming conventions for the various components, functions, parameters, thresholds, and other elements used herein are provided as examples, and can be given a different name or label. The use of the term “or” is not limited to exclusive “or” but can also mean “and/or”. 
     While there have been shown, described and pointed out fundamental novel features of the present principles, it will be understood that various omissions, substitutions and changes in the form and details of the methods described and devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit of the same. For example, it is expressly intended that all combinations of those elements and/or method steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the present principles. Moreover, it should be recognized that structures and/or elements and/or method steps shown and/or described in connection with any disclosed form or implementation of the present principles may be incorporated in any other disclosed, described or suggested form or implementation as a general matter of design choice. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto. 
     Having described preferred embodiments, which serve to illustrate various concepts, structures and techniques that are the subject of this patent, it will now become apparent to those of ordinary skill in the art that other embodiments incorporating these concepts, structures and techniques may be used. Additionally, elements of different embodiments described herein may be combined to form other embodiments not specifically set forth above.