The invention relates to surgical devices and packaging for same.
Most surgical procedures utilize electrosurgical devices for dissection and maintaining hemostasis. These devices produce smoke and vapors that may contain potentially infectious and/or carcinogenic byproducts. Much effort has been made to collect and control exposure to surgical smoke, however, the available devices are not readily adaptable to all electrosurgical handpieces and therefore require new equipment and greater cost. Alternatively, reusable electrosurgical handpieces are widely used mostly in the outpatient setting such as in primary care or dermatologic procedures. Many of these procedures require a sterile field such as in Mohs micrographic surgery.
Multiple designs have been produced comprising a disposable handpiece with incorporated suction, e.g., U.S. Pat. No. 5,234,428 to Kaufman and U.S. Pat. No. 8,057,470 to Lee et al. Disposable handpieces available at the time of this writing can be expensive and/or cumbersome to use. Other available devices comprise an attachable conduit or tubing system to an electrosurgical handpiece, such as U.S. Pat. No. 5,836,944 to Cosmescu; U.S. Pat. No. 5,224,944 to5 Elliott; and U.S. Pat. No. 6,146,353 to Platt. These devices are not adaptable to different handpieces. None of the devices listed above are available with an incorporated sterile barrier that can surround the reusable handpiece and cord.
Therefore, it would be desirable to provide an attachable suction tube or conduit kit contained within a sterile barrier sleeve that can accept a non-sterile reusable electrosurgical handpiece and provide a sterile barrier for the handpiece and cord that need to be on or near the sterile field. Additionally, the device can be provided with special electrodes that maximize the suction of smoke and debris from the surgical site.
The current invention provides a sterile barrier sleeve with an incorporated suction conduit or tube that attaches to any electrosurgical handpiece at the distal end and to any suction source at the proximal end. The device is packaged inside a sterile peel pouch so that when opened on the proximal end, a sterile handpiece can be lowered into the package through the sterile sleeve and into the distal tip that is made of soft plastic and readily accepts and attaches to the nose or distal tip of the electrosurgical handpiece. The sterile sleeve is folded on itself so that, when the handpiece is in place, the packaging can be removed, and the proximal end of the sterile sleeve can be pulled open to expand and cover the cord and suction tubing attached to the handpiece, in a manner similar to the use of camera drapes in surgical theaters.
An embodiment of the invention comprises a packaging system comprising a sterilized medical device; an elongated flexible tubular sleeve insertably receiving the sterilized medical device; and a peel-open pouch sealably containing the sterilized medical device and elongated flexible tubular sleeve.
In an embodiment of the invention, the elongated flexible tubular sleeve has a nominal length which is substantially greater than a nominal length of the sterilized medical device. The elongated flexible tubular sleeve may be shortened from its nominal length via accordion folding.
In an embodiment of the invention, the peel-open pouch has a closed distal end and a peel-open proximal end having juxtaposed free tabs for facilitating opening of the peel-open pouch. The sterilized medical device has a distal end disposed proximate the distal end of the peel-open pouch and a proximal end disposed proximate the proximal end of the peel-open pouch. The flexible tubular sleeve includes an open distal end disposed adjacent and surrounding the distal end of the sterilized medical device such that a distal tip of the sterilized medical device projects through the open distal end of the sleeve.
In an embodiment of the invention, the peel-open pouch has first and second juxtaposed sidewalls, wherein at least one of the sidewalls is fabricated from a material that is at least one of transparent and translucent. At least a portion of the flexible tubular sleeve is fabricated from a material that is at least one of transparent and translucent.
In an embodiment of the invention, the flexible tubular sleeve comprises a stretchable elastic material such that the flexible tubular sleeve closely conforms to an outer surface of the sterilized medical device.
In an embodiment of the invention, a tubular sleeve card is coupled to a proximal end of the flexible tubular sleeve, the tubular sleeve card surrounding at least a portion of a proximal end of the sterilized medical device. The tubular sleeve card further comprises a tab to facilitate grasping by a user. In an embodiment of the invention, the tubular sleeve card comprises a substantially blank of material formed into a tubular structure. The blank of material may comprise at least one of paper, paperboard, card stock, corrugated paperboard.
A method of providing a sterile sleeve barrier with incorporated tubing, comprising the steps of:
The external pouch may include first and second juxtaposed sheets of material, the first and second juxtaposed sheets of material being releasably and sterilizably couplable to one another.
In embodiments of the invention, the method further comprises one or more of the following steps:
An embodiment of the invention further comprises a method of use of a sterile sleeve barrier, comprising the steps of:
In embodiments of the invention the method of use of a sleeve barrier further comprises at least one of:
The aforementioned and other features and advantages of the invention will become further apparent from the following detailed description of the presently preferred embodiments, read in conjunction with the accompanying drawings, which are not to scale. The detailed description and drawings are merely illustrative of the invention, rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof.
While this invention is susceptible of embodiment in many different forms, there are shown in the drawings and described in detail herein, specific embodiments, with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention, and is not intended to limit the invention to the embodiment(s) illustrated.
The invention and accompanying drawings will now be discussed in reference to the numerals provided therein so as to enable one skilled in the art to practice the present invention. The drawings and descriptions are exemplary of various aspects of the invention and are not intended to narrow the scope of the appended claims. Unless specifically noted, it is intended that the words and phrases in the specification and the claims be given their plain, ordinary and accustomed meaning to those of ordinary skill in the applicable arts. It is noted that the inventors can be their own lexicographers. The inventors expressly elect, as their own lexicographers, to use only the plain and ordinary meaning of terms in the specification and claims unless they clearly state otherwise and then further, expressly set forth the “special” definition of that term and explain how it differs from the plain and ordinary meaning. Absent such clear statements of intent to apply a “special” definition, it is the inventors' intent and desire that the simple, plain and ordinary meaning to the terms be applied to the interpretation of the specification and claims.
The inventors are also aware of the normal precepts of English grammar. Thus, if a noun, term, or phrase is intended to be further characterized, specified, or narrowed in some way, then such noun, term, or phrase will expressly include additional adjectives, descriptive terms, or other modifiers in accordance with the normal precepts of English grammar. Absent the use of such adjectives, descriptive terms, or modifiers, it is the intent that such nouns, terms, or phrases be given their plain, and ordinary English meaning to those skilled in the applicable arts as set forth above.
Further, the inventors are fully informed of the standards and application of the special provisions of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112˜6. Thus, the use of the words “function,” “means” or “step” in the Detailed Description of the Invention or claims is not intended to somehow indicate a desire to invoke the special provisions of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112˜6 to define the invention. To the contrary, if the provisions of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112˜6 are sought to be invoked to define the inventions, the claims will specifically and expressly state the exact phrases “means for” or “step for” and the specific function (e.g., “means for roasting”), without also reciting in such phrases any structure, material or act in support of the function. Thus, even when the claims recite a “means for . . . ” or “step for . . . ” if the claims also recite any structure, material or acts in support of that means or step, or that perform the recited function, then it is the clear intention of the inventor not to invoke the provisions of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112˜6. Moreover, even if the provisions of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112˜6 are invoked to define the claimed inventions, it is intended that the inventions not be limited only to the specific structure, material or acts that are described in the illustrated embodiments, but in addition, include any and all structures, materials or acts that perform the claimed function as described in alternative embodiments or forms of the invention, or that are well known present or later-developed, equivalent structures, material or acts for performing the claimed function.
In the following description, and for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the various aspects of the invention. It will be understood, however, by those skilled in the relevant arts, that the present invention may be practiced without these specific details. In other instances, known structures and apparatus are shown or discussed more generally in order to avoid obscuring the invention. In many cases, a description of the operation is sufficient to enable one to implement the various forms of the invention, particularly when the operation is to be implemented in software. It should be noted that there are many different and alternative configurations, apparatus and technologies to which the disclosed inventions may be applied. Thus, the full scope of the inventions is not limited to the examples that are described below.
Various aspects of the present invention may be described in terms of functional block components and various processing steps. Such functional blocks may be realized by any number of hardware or software components configured to perform the specified functions and achieve the various results.
It may be observed that in surgical theaters or other medical operation situations, doctors, nurses and other personnel typically will have donned gloves, which may make grasping of thin flexible members, such as sleeve 24, difficult. Accordingly, it would be desirable to provide a mechanism to facilitate the extension of sleeve 24, without requiring the doctor, nurse, etc. to directly make contact with sleeve 24.
Accordingly, and referring specifically to
The present invention further comprises a method of providing a sterile sleeve barrier with incorporated tubing kit. Referring to
In an embodiment of the invention, the aforementioned method may further comprise one or more of the following:
An embodiment of the invention further comprises a method of use of a sterile sleeve barrier, comprising the steps of:
The method of use of a sleeve barrier may further comprise one or more of the steps of:
While the embodiments of the invention disclosed herein are presently considered to be preferred, various changes and modifications can be made without departing from the spirit and scope of the invention. The scope of the invention is indicated in the appended claims, and all changes and modifications that come within the meaning and range of equivalents are intended to be embraced therein.
Although the invention has been described with reference to the above examples, it will be understood that many modifications and variations are contemplated within the true spirit and scope of the embodiments of the invention as disclosed herein. Many modifications and other embodiments of the invention set forth herein will come to mind to one skilled in the art to which the invention pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the invention shall not be limited to the specific embodiments disclosed and that modifications and other embodiments are intended and contemplated to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
The present application claims priority under 35 U.S.C. §119(e) of the filing date of U.S. Ser. No. 63/410,797, filed 28 Sep. 2022, the complete contents and disclosure of which are hereby expressly incorporated by reference.
Number | Date | Country | |
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63410797 | Sep 2022 | US |