The present disclosure relates generally to scopes, such as laparoscopes, trocar assemblies, and related devices, and more specifically, to scopes for use with trocar assemblies, for example, which can be utilized in laparoscopic medical procedures.
Laparoscopic surgery is a minimally-invasive surgical technique typically performed with the assistance of one or more medical instruments inserted through a small incision in a patient's body. Laparoscopic surgery is often preferred to traditional and more invasive surgical procedures because of the reduced frequency and degree of certain postoperative side effects, such as postoperative pain, swelling, internal bleeding, and infection risk. The minimally-invasive nature of laparoscopic procedures may also result in decreased recovery times and shorter hospital stays.
Typical medical devices utilized during laparoscopic procedures have instruments mounted on an elongated metal or plastic body that are inserted into the patient's body and maneuvered to a target area within a body cavity (e.g., the abdominal, pelvic, thoracic, or chest cavity, where insufflation may be used to provide additional space in which to maneuver, which requires a fluid-patient barrier to maintain insufflation pressure in the cavity). One or more trocar assemblies are typically first inserted into the patient body at an incision site (for each), and the instruments access the patient body through the trocar assembly(ies).
Often, a medical device including a camera or other image-transmitting device is inserted through a trocar to transmit one or more images or a live video feed from within the body cavity to a medical professional (such as the surgeon). The device may be referred to as a scope or a laparoscope, and its transmission may guide the medical professional's actions during the laparoscopic procedure.
A problem typically experienced during laparoscopic procures involves a compromised image or video feed due to an obstructed lens of the laparoscope. This obstruction may be caused by condensation (e.g., fog) and/or debris such as bodily fluids or displaced tissue encountered by the lens during the procedure. Such obstruction is problematic because the lens of the laparoscope preferably remains contained in a pressurized and sterile environment (e.g., insufflated body cavity), and removing the lens from that environment for cleaning purposes may cause lengthy interruptions prolonging patient anesthesia and increasing a risk of compromised sterility.
In one aspect, a scope includes a housing having a distal portion with a distal end. A lens is at the distal end. A cleaning element is operatively coupled to the distal portion of the housing, wherein the cleaning element is movable between a first position and a second position contacting the distal end.
In another aspect, a trocar assembly includes a cannula having a proximal portion and an opposing distal portion. The distal portion is configured to extend into a patient body. The cannula defines an access channel between the proximal portion and the distal portion. A scope is movably positioned within the access channel. The scope can be maneuvered through the access channel to a location within the patient body. A cleaning element is operatively coupled to a distal portion of the scope. The cleaning element is configured to contact at least a lens of the scope.
In yet another aspect, a method for cleaning a distal end of a scope includes coupling a cleaning element at a distal portion of the scope. The distal portion is configured to extend into a patient body to a location within the patient body. At least a distal end of the scope is cleaned with the cleaning element by moving the cleaning element with respect to the distal end of the scope.
Various embodiments are described below with reference to the drawings in which like elements generally are referred to by like numerals. The relationship and functioning of the various elements of the embodiments may better be understood by reference to the following detailed description. However, embodiments are not limited to those illustrated in the drawings. It should be understood that the drawings may or may not be to scale, and in certain instances details may have been omitted that are not necessary for an understanding of embodiments disclosed herein, such as—for example—conventional fabrication and assembly.
The invention is defined by the claims, may be embodied in many different forms, and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey enabling disclosure to those skilled in the art. As used in this specification and the claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Reference herein to any industry and/or governmental standards (e.g., ASTM, ANSI, IEEE, HIPAA, FDA standards) is defined as complying with the currently published standards as of the original filing date of this disclosure concerning the units, measurements, and testing criteria communicated by those standards unless expressly otherwise defined herein.
The terms “proximal” and “distal” are used herein in the common usage sense where they refer respectively to a handle/doctor-end of a device or related object and a tool/patient-end of a device or related object. The terms “about,” “substantially,” “generally,” and other terms of degree, when used with reference to any volume, dimension, proportion, or other quantitative or qualitative value, are intended to communicate a definite and identifiable value within the standard parameters that would be understood by one of skill in the art (equivalent to a medical device engineer with experience in this field), and should be interpreted to include at least any legal equivalents, minor but functionally-insignificant variants, standard manufacturing tolerances, and including at least mathematically significant figures (although not required to be as broad as the largest range thereof).
In example embodiments, such as described herein, a trocar assembly includes a proximal portion. A cannula extends between the proximal portion and a distal portion of the trocar assembly opposite the proximal portion. The distal portion of the trocar assembly is configured to extend into a patient body. The cannula defines or forms an access channel between a first or proximal opening at the proximal portion and a second or distal opening at the distal portion. The access channel is configured to receive a scope, e.g., a laparoscope, such that the scope can be maneuvered through the access channel to extend distally from the distal portion of the trocar assembly at a location within the patient body. The scope includes an integral cleaning element positioned at or coupled to a distal portion of the scope. The cleaning element is configured to contact at least a distal end of the scope, e.g., with the cleaning element in a second position, to periodically clean at least the distal end of the scope, e.g., a lens of an imaging device at the distal end of the scope, to remove condensation (e.g., fog) and/or debris, such as bodily fluids or displaced tissue, from the lens during the procedure. In certain example embodiments, the cleaning element is configured to clean an entire distally facing surface of the lens, e.g., by temporarily occluding an opening at or near a distal end of the housing. With the cleaning element contacting the distally facing surface of the lens a complete cleaning of the entire lens surface can be accomplished.
In example embodiments, the cleaning element is movable between a first position allowing the scope to freely move in a proximal direction and/or a distal direction within the access channel and a second or cleaning position. In the second position, the cleaning element contacts at least the distal portion of the scope to clean desired portions of the scope, e.g., the lens. In certain example embodiments, the cleaning element includes a plurality of members, e.g., a plurality of brushes, bristles, fibers, fingers, leaflets, wipers, pads, projections, or any combination thereof such that the plurality of members contact the scope. The members may be formed of a compliant or flexible material such that each member is movable upon contacting the scope, e.g., to allow the scope to move through a housing of the scope without undesirable contact with or interference from the members, while providing sufficient resilience to facilitate cleaning the distal end of the scope, e.g., the lens.
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Film 106 also includes a second segment 112 adjacent first segment 108. Second segment 112 forms an opening 114 that is aligned with central opening 96 with cleaning element 50 in a first position to allow lens 42 to extend through central opening 96 and co-axially aligned opening 114, as show in
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Film 124 also includes a transparent second segment 130 adjacent first segment 126. Second segment 130 is positioned over lens 42 with cleaning element 50 in a first position. In this embodiment, after first segment 126 of film 124 is used to clean lens 42, film 124 is advanced through housing 44 such that second segment 130 adjacent first segment 126 is positioned over lens 42. As described above, housing 44 includes first slit 116 formed through housing 44 on first lateral side 118 of lens 42 and second slit 120 formed through housing 44 on second lateral side 122 of lens 42 configured to accommodate film 124. During advancement, film 124 is fed through first slit 116, laterally across lens 42, and into second slit 120. As film 124 is advanced in a lateral direction, used first segment 126 enters second slit 120 as second segment 130 exits first slit 116 to extend over lens 42.
In an example embodiment as shown in
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A central opening 144, e.g., a slit, is formed through expandable pad 140 such that when lens 42 contacts expandable pad 140 with sufficient force, lens 42 passes through central opening 144 to extend distally from housing 44 as shown in
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In another example embodiment as shown in
In example embodiment as described herein, a trocar assembly includes a cannula having a proximal portion and an opposing distal portion. The distal portion of the cannula is configured to extend into a patient body. The cannula defines an access channel between the proximal portion and the distal portion, wherein the access channel is configured to receive a scope such that the scope can be maneuvered through the access channel to a location within the patient body. The scope is movably positioned within the access channel. A cleaning element operatively coupled to a distal portion of the scope, e.g., integrally coupled to the distal portion of the scope, is configured to contact at least a lens of the scope to remove condensation and/or debris from the lens and/or other portions of the scope during the procedure.
In example embodiments as described herein, a method for cleaning a distal end of a scope, e.g., a lens of the scope, includes coupling a cleaning element at a distal portion of the scope. The distal portion is configured to extend into a patient body to a location within the patient body. At least a distal end of the scope, e.g., the lens, is cleaned with the cleaning element by moving the cleaning element with respect to the distal end of the scope.
In example embodiments, cleaning element 50 includes one or more surfaces configured to contact the distal end of scope 40 with cleaning element 50 in a second position. Further, in certain embodiments, cleaning element 50 is movable between a first position and a second position via contact of cleaning element 50 with scope 40 or lens 42. In certain example embodiments, cleaning element 50 may include one or more members, e.g., a plurality of members, configured to clean lens 42 upon contact with lens 42. Suitable members include, without limitation, one or more, e.g., a plurality of, brushes, bristles, fibers, fingers, leaflets, wipers, bands, pads, projections, or any combination thereof. In certain example embodiments, each member is made or formed of a suitable flexible or compliant material to allow each member to move upon contacting scope 42 to allow scope 42 to freely move with respect to housing 44 as controlled by the user, e.g., the surgeon. While each member may be flexible or compliant, each member has sufficient resilience or rigidity to properly clean lens 42 as well as other portions of scope 10.
As described herein, example trocar assemblies for use during a laparoscopic procedure include a cannula having a distal end for placement into a patient body during the laparoscopic procedure. The distal end of the cannula may include a beveled or sharpened end to facilitate entry of the cannula into the patient body. An obturator may additionally or alternatively be included. The cannula may include certain surface characteristics, such as threads or ridges, to enhance the stability of the trocar assembly when inserted into a body incision.
The cannula may include or may be in fluid communication with a chamber defined by a proximal portion of the trocar assembly. The chamber may have a proximal opening configured to receive medical devices used during laparoscopic surgery, including, without limitation, graspers, dissectors, needles, scissors, clamps, electrodes, forceps, a camera, and/or a laparoscope (a “scope”). A valve may be located in the proximal opening and may form a seal or fluid barrier between the chamber and an external environment (e.g., the ambient room environment). Alternatively or in addition, the valve may be located in another location (such as at a distal opening of the cannula). It may be advantageous for at least one valve to be located at a the proximal opening such that a lens of a scope does not have to pass through the valve prior to cleaning, thereby reducing or eliminating the chance of materials from the valve dirtying the scope's lens after cleaning.
The chamber may be subjected to a continuous sterile and pressurized environment that extends through the cannula and to the body cavity (herein referred to as the “internal environment” even though the continuous region may extend external of the patient body wall, e.g., within the trocar assembly). This may be advantageous if maintaining insufflation of the body cavity is desired during all operation—including cleaning—of a trans-trocar-located scope or other device. Further, the controlled environment of the chamber may reduce fogging of a scope by eliminating or reducing temperature changes and/or changes in humidity.
The valve (which may include more than one valve) may include a particular structure that allows certain medical devices to pass through the proximal opening and into the chamber while maintaining the seal or fluid barrier. For example, the valve may include a duckbill seal, an annular seal structure, or both, but other suitable structures may additionally or alternatively be included. The valve may be formed with a compliant material such that it expands or contracts as necessary for compatibility with scopes of different sizes. For example, on the Shore Hardness Scale, the valve may be formed of a material with a hardness between about Shore A 20 to about Shore A 80, such as from about Shore A 30 to about Shore A 60.
An insufflation inlet may communicate with the chamber and may be configured to control the pressure and other characteristics (e.g., temperature, composition of the atmosphere), which may be advantageous for providing precise control of insufflation of a body cavity during the laparoscopic procedure. The insufflation inlet may include an insufflation valve, and may be in fluid communication with a pump or other suitable pressure source. Advantageously, the flow of gasses or other contents received into the chamber through the insufflation inlet may be introduced in a manner such that the effect of the flow across cleaning element is reduced or eliminated. For example, when the cleaning element (which is described in detail above) is wetted with a cleaning fluid, concerns of increased evaporation due to fluid flow over the cleaning element may be alleviated.
The trocar assembly may provide an entry or point of access into the body for a scope. In non-limiting embodiments, the scope may include a commercially-available rigid laparoscope with a 5 millimeter (mm) or a 10 mm diameter (or any other suitable diameter) with either a non-angled lens or an angled lens, which may be angled at 30 degrees, 45 degrees, or 50 degrees, for example, with respect to the longitudinal axis of the scope. At least a distal end of the scope may include one or more elements designed to magnify, reflect, illuminate, and/or capture images of internal body areas under treatment, and then transmit those images back to the medical professional controlling the procedure (herein referred to as a “viewing element”). The scope may be inserted into the proximal opening of the chamber, may extend through the chamber, and may extend through into the cannula through a distal opening in the bottom wall of the chamber, where the distal opening is in fluid and mechanical communication with the cannula. The scope may further extend distally to the distal end of the cannula and into the body cavity. In some embodiments, a sleeve (not shown, but readily understood as a lining layer) may be located within the cannula, and the scope may pass through the sleeve. Once deployed, the scope may be manipulated by the medical professional moving it distally/proximally, angling it, and/or by rotating it into a particular orientation. Typically, during laparoscopic procedures, scopes can become obstructed when debris (e.g., condensation, displaced tissue, bodily fluids) are encountered and accumulate on a lens of the scope, which may compromise the image or video feed provided to the medical professional.
The surface of the cleaning element may facilitate removal of obstructions from the scope without necessitating removal of the scope from the internal environment. Advantageously, lengthy interruptions (and therefore increased surgical and anesthesia time) due to removing and/or replacing an obstructed scope may be reduced or eliminated. Further, the distal end of the scope may remain in the sterile internal environment during cleaning, which may advantageously alleviate concerns related to loss of sterility within the internal environment due to the removal and re-entry of the scope one or more times for cleaning purposes. Keeping the scope within the internal environment may also reduce or eliminate debris in the form of fogging or condensation caused by exposure to pressure and/or temperature changes when switching between environments. It should also be understood that certain advantages of the present embodiments are generally described as relating to a scope for explanation purposes and may also extend to other types of instruments used during surgical procedures, and therefore “scope” should be understood as including any suitable medical device used during laparoscopic surgery when described in the context of the present embodiments, unless clearly excluded.
The cleaning element may incorporate any suitable structures, materials, and/or cleaning solutions for removing obstructions from the scope. The cleaning element may have a unitary construction, or alternatively may have multiple surfaces or layers with different cleaning characteristics or properties for facilitating multiple treatments. For example, it is contemplated that the cleaning element may have a first region with an abrasive surface for breaking up potential obstructions, a second region including a liquid, a gel, or other material for dissolving or washing away the obstructions, and a third region with an absorbent or adsorbent surface for removing any remaining residue.
The cleaning element may include any suitable cleaning structures or materials, such as sponges, foams (e.g., reticulated or non-reticulated foamed plastic polymers forming open-cell, semi-open cell, or closed-cell foam structures), fibrous materials (e.g., materials with natural (e.g., cellulosic) and/or synthetic fibers), microfiber or wipe materials (e.g., polyethers, polyamides, polyesters, and/or blends of each in a woven or non-woven construction with split or non-split fibers), hydrophilic or hydrophobic materials, fluids, gases, bristles, films, etc. The structures and/or materials of the cleaning element may include hydrophobic properties to assist in absorbing and wicking of various bodily fluids and/or lipophilic characteristics for increased absorption of oils or fats. The cleaning element may be capable of absorbing at least 5 times its original weight of fluids, such as about 15 times its original weight (or more). When the cleaning element includes pores, consistent or variable pore sizes may be consistently or randomly dispersed (or layered) in certain configurations for suitable absorption properties (for example, a the cleaning element may include a micro-porous foam with about 4 pores per inch to about 100 pores per inch). The cleaning element may have a firmness/compliance of about 2 lbs/50 in2 to about 80 lbs/50 in2, and preferably about 6 lbs/50 in2 to about 45 lbs/50 in2 (when tested at 25% deflection on a 20 inch by 20 inch by 4 inch specimen). The material(s) of the cleaning element may be formed of a material suitable for use in a medical device (e.g., with suitable biocompatibility, non-linting/no particulate, tear resistance, sterilization or other chemical/solvent compatibility, and radiation stability).
The cleaning element may be multi-layered in some embodiments. For example, a first layer may be configured to absorb a fluid obstruction located on the scope, and a second layer may be configured to retain or discard that fluid. In some embodiments, the first layer may include an open-cell foam with relatively low density (such as polyurethane or silicone foam) that may be used to effectively and quickly absorb (or wick, etc.) the obstructing fluid, and the second layer may include higher-density foam for effectively retaining the fluid. The second layer may be located beneath (e.g., covered by) the first layer, for example. Fibrous materials such as terrycloth and microfiber cloths may additionally or alternatively be used and may be advantageous for providing a streak-free lens surface when wiped against the scope. The solid materials of the cleaning element may be combined or “wetted” with a cleaning fluid, such as an anti-fog fluid, sterile water, saline, or a detergent, for example, which may facilitate the removal of fatty smudges and dried-on debris.
In the event the medical professional's visibility becomes compromised due to obstruction of the scope during surgery, the distal end (or other location) of the scope may then be wiped or swept by pressing and/or rubbing the distal end of the scope on the cleaning element to remove obstructions. As explained above, this cleaning procedure may advantageously be completed without removing the scope from the internal environment in the trocar assembly. In certain embodiments, the cannula may be formed of a transparent or translucent material. When the scope is located in the trocar assembly, the scope (which often includes a light) may illuminate the cannula to increase visibility.
In some embodiments, the cleaning element may be selectable, removable, and/or replaceable. Thus, the trocar assembly may be capable of allowing access into the chamber (e.g., in an operating room prior to a surgery) such that a medical professional can select an appropriate version of the cleaning element and then use that cleaning element with the trocar assembly during the procedure. The cleaning element may additionally or alternatively be replaced during a medical procedure (e.g., if it becomes soiled), and/or may be replaced between medical procedures during reprocessing of the trocar assembly if the trocar assembly is reusable.
Those of skill in the art will appreciate that existing scopes and potential scope designs include at least one non-longitudinal, distal-end-facing surface of the distal end that may be generally or exactly perpendicular to the longitudinal axis of the scope, or which distal-facing surface may be configured at a non-perpendicular angle relative to the longitudinal axis (e.g., 30 degrees off-perpendicular, 45 degrees off-perpendicular). It is further contemplated that the distal-facing surface of the scope may be flat/planar, concave, or convex relative to the major plane of that face. The term “non-longitudinal, distal-end-facing surface” is meant to include the operative end face(s) of a scope in distinction from the longitudinal lateral sides of the scope, which will generally be columnar or cylindrical. Thus, as described in more detail below, the surface characteristics of the cleaning element may be shaped or otherwise configured for compatibility with a variety of distal-facing surfaces of the scope.
Those of skill in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the claims, including that features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies while remaining within the scope of the claims. This specifically includes that the structure, location, and mechanisms of the disclosed cleaning elements and related structures in the different embodiments illustrated and described with reference to the drawing figures may be combined and elements interchanged within the level of skill in the art as informed by this application, and within the scope of the present claims, which includes that a variety of disclosed individual cleaning element components dimensioned for use encompassed within in laparoscopy trocars may be configured as separable/replaceable components of a larger trocar assembly. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation unless specifically defined by context, usage, or other explicit designation. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. And, it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention. Furthermore, the advantages described above are not necessarily the only advantages of the invention, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment. In the event of any inconsistent disclosure or definition from the present application conflicting with any document incorporated by reference, the disclosure or definition herein shall be deemed to prevail.
This application claims the benefit of U.S. Provisional Application No. 62/513,270, filed May 31, 2017, and U.S. Provisional Application No. 62/513,278, filed May 31, 2017, each of which is herein incorporated by reference in its entirety. Further, each of the following applications, filed on Mar. 7, 2017, is herein incorporated by reference in its entirety: U.S. patent application Ser. No. 15/452,169, U.S. patent application Ser. No. 15/452,211, and U.S. patent application Ser. No. 15/452,246.
Number | Date | Country | |
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62513270 | May 2017 | US | |
62513278 | May 2017 | US |