Patent Description:
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's legs or place the assist in an ergonomically challenging position of holding the cystoscope sheath over the patient'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's hands that hold the cystoscope sheath are more prone to exposure of harmful radiation during fluoroscopic imaging. The doctor'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. In closest prior art <CIT> patent application is disclosed a flexible holder and clamping assembly designed to hold cystoscopes and other endoscopic instruments in place on examination tables. It is equipped with securing assembly for different sizes of instrument with elongated shafts. The securing assembly includes C-shaped jaw. The instrument shaft can be slid sideways into the C-shaped jaw and secured. C-shape is configured to receive elongated shaft, described prior art does not provide sufficient securing stability including to the scope sheath. In present invention it is foreseen elements for stabilization of scope sheath with different diameters shafts like scope sheath inflow port and outflow port and sheath positioned in between.

This and other aspects of the invention are achieved by a scope sheath stabilization system as defined in claim <NUM>.

The scope sheath stabilization system is designed to be fixable on a table-mounted flexible or rigid arm. It includes a scope sheath engaging portion that securely attaches and holds the scope sheath in place, preventing any movement during use.

The scope sheath engaging portion consists of an inverted U-shaped device with a top portion is configurated to be connected to the table mountable flexible or rigid arm engaging portion, and two downward-extending legs. Each leg has a hook at the bottom to engage the underside of the scope sheath, while a plunger mechanism extending downward from the top portion engages the upper surface of the scope sheath, securing it firmly in place.

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 understood that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the present principles, which should be made by reference to the appended claims. It is further understood that the drawings are not necessarily drawn to scale and, unless otherwise indicated, are merely intended to conceptually illustrate the structures and procedures described herein.

In the drawings wherein like reference numerals denote similar components throughout the views:.

Referring to <FIG>-1F, there is shown the endoscopic sheath stabilization system <NUM> (hereinafter referred to as the "sheath holder" <NUM>) according to an embodiment of the invention. In this embodiment, the sheath holder <NUM> includes a sheath engaging portion <NUM>, which comprise a sheath engaging plunger assembly <NUM>, <NUM>, <NUM>, and a table-mountable flexible or rigid arm connection portion consisting of a shaft <NUM> that (as will be described in further detail below) houses the shaft <NUM> of the sheath engaging plunger assembly. At a top end of shaft <NUM> is a safety knob <NUM> 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 <NUM> has a generally upside down or inverted U shape with a central upper portion <NUM> and two downwardly extending legs 24A and 24B. At the bottom of each leg 24A and 24B is a hook 26A and 26B, respectively, that is configured to engage and hold onto the scope sheath inflow and outflow ports.

At the base of the shaft <NUM> of table-mountable flexible or rigid arm connection portion are included one or more connection points <NUM> that are configured to receive screws <NUM> which pass through holes <NUM> in the sheath engaging portion <NUM> (see <FIG>). In this manner, the bottom of shaft <NUM> is connected to the central upper portion <NUM> of the sheath engaging portion <NUM> as shown. Within the shaft <NUM> is positioned a slidable and spring biased plunger <NUM> having a foot <NUM> and which foot <NUM> includes a beveled or curved surface <NUM>. The beveled or curved surface <NUM> of foot <NUM> is shaped 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 shown. Those of skill in the art will appreciate that variations in the shape of foot <NUM> can be made without departing from the intended scope of the invention. Plunger <NUM> with foot <NUM> is preferably spring biased downward.

In accordance with other embodiments, the plunger <NUM> is manually locked into place once the foot <NUM> 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 <NUM> and engaging an internal side of the plunger <NUM>. Another example includes one direction or one-way ratcheting mechanism with a releasesuch that when the plunger <NUM> is pressed downward against the sheath, a ratcheting mechanism inside the shaft <NUM> includes teeth that a ratchet pawl on, the plunger engages and lock into at each downward increment until locked against the sheath surface. A ratchet pawl release allows for removal of the plunger against the sheath.

According to one preferred implementation the table mountable flexible arm or rigid arm connection portion (e.g., the shaft <NUM>) is made of surgical steel. The sheath engaging portion <NUM> is also preferably made from surgical steel. In other applications or uses, the material the device of the present invention is made from includes one or more of materials such as titanium, aluminum, and various types of plastics.

<FIG> show a table-mountable flexible arm <NUM> having an end <NUM> that includes a hole or aperture <NUM> therein. A securing knob <NUM> has a shaft <NUM> with an end <NUM> that is in communication with the aperture 34such that tightening of the securing knob causes the end <NUM> to engage shaft <NUM> of the sheath holder <NUM> 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 mountable flexible or rigid arm system as described herein is common to a vast array of surgical procedures. These table mountable systems are anchored to a bar or rail that is mounted on the side of the operating table, commonly used for these types of systems. The stabilization system for cystoscopy as disclosed herein comprices a dedicated flexible or rigid arm that connects directly to the bar or rail on the operating table, independent of other table mounted stabilization systems.

<FIG> show an example of how the shaft <NUM> engages the aperture <NUM> of the table-mountable flexible arm <NUM> and is secured in place as described above with reference to <FIG>.

Referring to <FIG>, there is shown a cystoscope sheath <NUM> having inflow and outflow ports <NUM> and an upper surface <NUM>. Although shown in <FIG>, <FIG> show enlarged views of how the sheath holder <NUM> engages and secures to the sheath <NUM>. As shown, the sheath <NUM> is positioned between the two downwardly extending legs 24A and 24Bsuch that the plunger 16is pushed upward against its spring bias. The foot <NUM> with beveled or curved surface <NUM> engages the upper surface <NUM> of the sheath. The hooks 26A and 26B hook underneath the inflow and outflow ports <NUM> as shown.

The spring biased plunger <NUM> places a downward force on the sheath <NUM>, pressing the same against the stationary hooks 26A and 26B, and thereby operates to completely stabilize the sheath <NUM>. Once stabilized, the position of the sheath <NUM> is now completely adjustable and capable of being secured in any desired position through the sheath holder, as connected to the table-mountable flexible arm <NUM> through shaft <NUM> and securing knob <NUM>. This now allows for the introduction of the cystoscope (not shown) into the sheath 40and completely eliminates the need for any personnel to hold or otherwise manually maintain the position of the scope during a surgical procedure.

In further embodiments of the invention, the manner in which the sheath holder <NUM> is connected to the table-mountable flexible or rigid arm is adjusted without departing from the intended scope of the invention. <FIG> show a quick grip attachment system <NUM> positioned at the end of the table-mountable flexible arm <NUM>. The quick grip attachment system <NUM> includes a channel or slot <NUM> configured to receive the shaft <NUM>, and a locking handle <NUM> that, when closed (<FIG>) compressed against and secure the shaft <NUM> immovably in the channel <NUM>.

<FIG> show an anvil attachment style connection mechanism <NUM> for connecting the sheath holder <NUM> to the table-mountable flexible arm <NUM> via shaft <NUM>. Here, the connection mechanism includes an opening <NUM> to receive the shaft <NUM>, and a sliding collar <NUM> that locks into place with a rotating collar or knob <NUM>. The rotating collar or knob <NUM> is rotated and translates (via threads not shown) to push and tighten down the sliding collar <NUM> against the shaft <NUM>. In one embodiment a V-shaped feature is included on the rotating collar <NUM>.

<FIG> show another anvil attachment style connection mechanism <NUM> for connecting the sheath holder <NUM> to the table-mountable flexible arm <NUM> via shaft <NUM>. This connection mechanism includes a base <NUM> positioned at the end of the table mountable flexible arm and which includes a receiving channel <NUM> positioned transverse thereto. A locking knob <NUM> is internally threaded such that when the shaft <NUM> is positioned in the receiving channel <NUM>, it can be locked into place using the knob <NUM> operating like a screw clamp onto the shaft while contained in the channel <NUM>. In accordance with other embodiments, the shaft <NUM> includes a notch or groove (e.g., V-shaped) configured to be engaged by the end of the threaded member controlled by knob <NUM>, which has a complementary shape to the notch or groove.

<FIG> show another connection mechanism <NUM> that is a quick connect connection mechanism. In this embodiment, a quick connect collar <NUM> is positioned on the end of the table-mountable flexible arm <NUM> and has a receiving aperture <NUM>. A connector <NUM> that is geometrically sized and shaped to fit into receiving aperture <NUM> is positioned off the back of the sheath holder <NUM> such that insertion of the connector <NUM> into the aperture <NUM> (and with actuation of the collar <NUM>) locks and secures the sheath holder <NUM> into the end of the flexible arm.

<FIG> show an alternative embodiment of the sheath holder <NUM> according to yet another embodiment. In this embodiment, the table-mountable flexible or rigid arm engaging portion and the sheath engaging portion <NUM> are one in the same and is configured to be fastened directly to an end <NUM> of the table-mountable flexible arm <NUM> with screws <NUM>, and includes legs 124A and 124B, with hooks 126A and 126B respectively. The plunger assembly includes a shaft <NUM> with a spring <NUM> positioned around the same. At the bottom of the plunger shaft <NUM> is the foot <NUM> with the beveled or curved surface <NUM>. A hole <NUM> is provided at the top of the flexible arm to allow the shaft <NUM> 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.

Claim 1:
A scope sheath (<NUM>) stabilization system (<NUM>) comprising:
a scope sheath engaging portion (<NUM>), and
a shaft (<NUM>) configured to securely attach the stabilization system to a table mounted flexible or rigid arm (<NUM>), characterised in that
the scope sheath engaging portion (<NUM>) comprises an inverted U-shape device having an upper portion connected to the shaft (<NUM>) and two downward extending legs (24A) and (24B) each having a hook (26A) and (26B) positioned at a bottom thereof and configured to engage a scope sheath from an underside of the inflow port and
the outflow port (<NUM>) of the scope sheath (<NUM>), respectively; and that the shaft (<NUM>) comprises a plunger assembly (<NUM>), (<NUM>), (<NUM>),
extending downward from the top portion and placed between the two downward extending legs (24A) and (24B) and configured to engage an upper surface (<NUM>) of the scope sheath (<NUM>) to secure the scope sheath from any movement once positioned in the scope sheath (<NUM>) engaging portion (<NUM>).