Patent Application
20210339297
The present disclosure relates to the simultaneous cleaning and inspection of surgical instrument lumen(s). More particularly, it relates to systems for inspection systems appropriate for use with the cleaning of a surgical instrument lumen, such as an endoscope lumen or channel, in a liquid (e.g., water) environment.
A plethora of different surgical instruments incorporate a tubular design in which one or more lumens or channels are utilized to facilitate caregiver interface with a target site inside the patient's body. For example, irrigation, suction, additional instrument(s), etc., are commonly delivered to an internal treatment site via the lumen(s) of a surgical instrument. Endoscopes are but one example of a surgical instrument providing at least one lumen (sometimes referred to as a “channel” in the context of endoscopes).
Regardless of exact form, under circumstances where the particular surgical instrument is intended and designed for repeated use, the instrument must be sterilized or high level disinfected prior to each use. And prior to the sterilization or high level disinfection, all debris and foreign matter must be removed from all surfaces of the instrument, both inside and out. In other words, the internal surfaces of the surgical instrument otherwise defining the instrument's lumen(s) must be cleaned.
Currently, the process after a procedure to clean a surgical instrument starts in the operating field. A surgical technician wipes the outside of the surgical instrument and flushes out the lumen(s) with sterile water or enzymatic solution (depending upon the procedure for which the surgical instrument was used). The next step is to manually clean the surgical instrument with an enzymatic solution in a decontamination or reprocessing area of the caregiver's facility. This process is performed at a sink filled with enzymatic solution. To clean surgical instrument lumen(s) (e.g., the lumen(s) or channel(s) of an endoscope), a technician inserts a brush into the lumen while submersed in the enzymatic solution. The technician manipulates the brush with back-and-forth and twisting motions, scrubbing debris and residue from the internal surfaces. With sufficient time and effort, this traditional cleaning technique can be effective in removing all debris from the lumen surfaces. However, the technician has no way of knowing in advance the time and effort required for a particular cleaning task as the physical constraints and type(s) of debris encountered vary widely. Moreover, because the lumen surfaces are internal or “hidden” relative to an exterior of an otherwise non-transparent surgical instrument (e.g., typically formed of surgical grade stainless steel or the like), the technician has no way of visually evaluating cleanliness of the lumen surfaces with the naked eye. It is exceedingly difficult to fully clean what the technician cannot see. An additional concern with traditional brush cleaning is that bristles of the brush may detach from the cleaning tool and problematically become lodged within the lumen. To confirm that no brush particulates or foreign debris are left in the lumen, many institutions have the technician, after using the brush to clean the lumen, use a borescope to visually confirm that the internal areas of the device are cleaned to expectations. Today, this two-step process of cleaning and inspection can be performed at the sink with waterproof borescopes
Multiple surveys and clinical evaluations have documented that surgical instrument lumens (such as endoscopic channels) are still not fully clean following traditional cleaning. Most have reported that 60%-80% of lumens are still dirty when inspected following a traditional cleaning process.
The inventor of the present disclosure recognized that a need exists for devices and methods that address one or more of the above problems.
Some aspects of the present disclosure are directed toward a surgical instrument cleaning brush assembly and corresponding methods of use. The brush assembly includes a surgical instrument cleaning brush attached to (e.g., permanently attached to) at least one retention clip. The retention clip is configured for releasable assembly to an exterior surface of a borescope. During use, the retention clip is fastened to a borescope; the brush assembly/borescope is then inserted into the surgical instrument lumen to be cleaned. The retention clip holds the cleaning brush in place relative to the borescope, affording the technician the ability to clean the lumen or channel with the cleaning brush (e.g., the borescope is moved in a back-and-forth manner, with this movement being transferred onto the cleaning brush) while visually observing the cleaning action at the time of cleaning. Direct visualization during the cleaning process allows the technician to visually confirm they have cleaned the lumen(s) to their expectations, thus increasing efficiency and efficacy in the cleaning process. At the conclusion of a particular cleaning task, the brush assembly can be disassembled from the borescope and then disposed of or refurbished/cleaned for subsequent re-use with another cleaning task.
One embodiment of a surgical instrument cleaning brush assembly 20 in accordance with principles of the present disclosure in shown in
The brush 30 can assumes various forms appropriate for cleaning a surgical instrument lumen or channel, and in some embodiments is, or is akin to, a brush conventionally used for manually cleaning of a surgical instrument lumen or channel. The brush 30 generally includes a shaft 40 and carrying or secured to a plurality of bristles 42. The shaft 40 can have various forms, and can be generally constructed to exhibit radial flexibility and axial rigidity. For example, in some non-limiting embodiments, the shaft can be length of twisted metal wire(s). Other constructions are also acceptable. While the shaft 40 is generally shown as being a single, continuous body, in other embodiments the shaft 40 can be defined or generated by two or more structures attached to one another.
The bristles 42 are each attached or otherwise secured to the shaft 40 so as to extend in a generally radial fashion relative to a central axis of the shaft 40. A bias or pattern can be generated by an arrangement of the bristles 42 along the shaft 40. The bristles 42 can assume various forms, and in some embodiments, are or include a polymer material. In some non-limiting examples, the bristles 42 are nylon, polypropylene, microfiber, etc., although other materials are also acceptable including materials developed in the future that are beneficial for cleaning surgical instrument lumens. The bristles 42 can have various diameters, for example in the range of 1-25 mm. A length of each of the bristles 42 (e.g., distance of radial extension from the shaft 40) can vary as a function of an intended end-use cleaning application (e.g., a size of the surgical instrument lumen to be cleaned), and in some embodiments can be in the range of 5-25 mm. Regardless, an outer diameter collectively defined by the bristles 42 is greater than an outer diameter of the shaft 40.
The shaft 40 defines an overall length of the brush 30, with the bristles 42 being secured to or extending along a distal region of the shaft 40. A length of the shaft 40, and thus a length of the brush 30, can vary as a function of an intended end-use application. In some embodiments, the shaft 40 can have a length in the range of 10-318 cm (4-125 inches). Regardless, at least some, optional all, of the shaft 40 proximal the bristles 42 can be exposed or otherwise available for securement to the retention clip(s) 32.
The retention clip(s) 32 can assume various forms conducive to selective connection or mounting to a borescope. With additional reference to
The retention clip(s) 32 can be formed from a material that will not readily degrade in the presence of cleaning liquids or solutions commonly employed for surgical instrument cleaning tasks. A material of the retention clip(s) 32 is optionally selected to exhibit a relatively high coefficient of friction with an expected material and/or surface features of a conventional borescope so as to more readily establish a non-sliding interface when assembled thereto. In other optional embodiments, at least an interior surface of the connection section 52 can include or form surface features that provide enhanced purchase with the surface of a conventional borescope.
As reflected by
As implicated above, the brush assembly 20 is configured for use with a borescope. The borescopes with which the present disclosure can be useful can assume various forms as known in the art, and borescopes of the present disclosure generally include a guide tube (or “borescope guide tube”) carrying an optical relay system by which an image at an objective end of the guide tube is delivered or relayed to an imaging end. Further, the guide tube incorporates or carries various optical components (e.g., fiber optics, light guides, etc.) for delivering light to the objective end (and illuminating the area to be observed at the objective end). The guide tube can have a relatively small outer diameter, for example on the order of 2 mm in some non-limiting embodiments. A light port is provided with the borescopes of the present disclosure, adapted to interface with the illumination source in directing light from the illumination source into and along the guide tube (that in turn is configured to, or carries components configured to, transmit or direct the light to the objective end). The guide tube can have a flexible construction as is known in the art.
With the above in mind,
Upon final assembly, the shaft 40 is maintained side-by-side with the borescope guide tube 60. Relative to the segment of the borescope guide tube 60 along which the shaft 40 is located, the shaft 40 extends substantially parallel (e.g., within 5% of a truly parallel relationship) to the borescope guide tube 60, and can flex or deflect in tandem with the corresponding segment of the borescope guide tube 60. During use, then, and as generally reflected by
Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
This Non-Provisional Patent Application claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 63/017,349, filed Apr. 29, 2020, the entire teachings of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63017349 | Apr 2020 | US |
