The present disclosure relates to a storage device, and more specifically to a storage device for medical components utilized in an operating theater.
Various types of surgical devices are used for performing medical procedures on organs, tissues, and/or vessels. In many cases, the medical procedure involves inserting surgical tools, devices, or components thereof, into the body of a patient through a natural orifice or an incision. Surgical tools inserted into the body may be removed prior to the completion of the medical procedure, or may be designed to remain within the body. In cases where the surgical tools, and components thereof, are intended to be removed from the patient, an accounting of all components must be rigorously performed to ensure nothing is left inside the body. Surgical tools or components unintentionally left in the body require additional surgical procedures for removal. Additionally, as tools and components are used, replaced, interchanged, or reloaded, contaminated tools or components quickly litter the operating theater. These used tools or components typically retain biological waste thereon, such as, for example, blood or bodily fluids, and must be contained in a manner to avoid contamination with sterile equipment or the surrounding environment.
Accordingly, it is highly desirable for an operator to easily and efficiently account for the quantity of tools or components introduced into the operating theater, retain introduced tools or components before or after use, and verify prior to closing an incision or completing the medical procedure that all introduced tools or components are accounted for. Additionally, when using tools with interchangeable or reloadable components, there is a further desire to maintain an accurate count of the new and/or used components, to ensure that a used component is not re-inserted into the body unintentionally. A further desire is to retain and account for any tools or components that may have broken during use, to ensure that a broken component is not re-inserted into the body unintentionally.
The present disclosure relates to a storage device for medical components utilized in an operating theater. The storage device includes a receiving portion adapted to support a component and a retaining member coupled to the receiving portion. The retaining member is transitionable between an initial configuration and a deployed configuration, and includes at least one securing region. The at least one securing region is circumscribed by material of the retaining member. In the deployed configuration, the retaining member is spaced away from a plane defined by a surface of the receiving portion. The at least one securing region of the retaining member is configured to receive a component therein.
In an embodiment, the retaining member and the surface of the receiving portion are coplanar in the initial configuration. The receiving portion may further include a raised lip extending along an outer perimeter. The at least one securing region may further define a perforated pattern. The storage device may further include an attachment member coupled at a first end to the receiving portion. The attachment member has a second end configured to temporarily affix to a receiving slot disposed on the receiving portion. The storage device may further include a plurality of retaining members, where each retaining member of the plurality of retaining members is independently transitionable between the initial and deployed configurations. The receiving portion of the storage device may further include an absorbent area. The receiving portion may further include a perimeter configured to increase frictional resistance, such that the component is frictionally inhibited from escaping the receiving portion. The retaining member may further be configured to be temporarily fixed in the initial configuration and biased into the deployed configuration. Once the retaining member is released from the initial configuration, the retaining member assumes the deployed configuration. The at least one securing region of the retaining member may be configured to receive a component such as a reloadable staple cartridge, a reloadable tack cartridge, a removable end effector, and a surgical mesh.
In another embodiment, the storage device includes a receiving portion adapted to support a component, a retaining member coupled to the receiving portion, and an attachment member. The retaining member is transitionable between an initial configuration and a deployed configuration, and includes a plurality of securing regions. The attachment member is coupled at a first end to the receiving portion and has a second end configured to temporarily affix to a receiving slot disposed on the receiving portion. In the initial configuration the retaining member is coplanar with the receiving portion, and in the deployed configuration the retaining member is spaced away from a plane defined by a surface of the receiving portion. A component is insertable through each of the securing regions of the plurality of securing regions of the retaining member. Each securing region of the plurality of securing regions is further configured to exert a compressive force upon an outer surface of the component such that the component is secured to the storage device. In another embodiment, a kit is provided. The kit includes a storage device and a component. The storage device includes a receiving portion and a retaining member coupled to the receiving portion. The retaining member is transitionable between an initial configuration and a deployed configuration, and includes a securing region. The securing region is defined by a contiguous outer surface. In the deployed configuration, the retaining member is spaced away from a plane defined by a surface of the receiving portion. A component is insertable into the securing region. The kit may further include a tool. The tool may be a surgical stapler, a surgical tack applier, a reloadable fixation device, a vessel sealer, an ablation probe, an endoscopic instrument, and a retractor. The component may be a reloadable staple cartridge, a reloadable tack cartridge, a removable end effector, and a surgical mesh. The storage device may further include an attachment member coupled at a first end to the receiving portion and have a second end configured to temporarily affix to a receiving slot on the receiving portion. The attachment member may temporarily secure the storage device to the component or the tool.
In another embodiment, a method of storing a tool or component is provided. The method includes transitioning a retaining member of a storage device from an initial configuration into a deployed configuration. In the deployed configuration the retaining member is spaced away from a plane defined by a surface of a receiving portion of the storage device. The method further includes approximating a component to a securing region of the retaining member, where the securing region defines a perforated pattern, and inserting the component through the securing region and through a thickness of the retaining member, such that the component is affixed thereto. The method may further include separating the storage device from a tool. The storage device may be attached to the tool with an attachment member. The method may additionally include providing the storage device in the initial configuration, where the retaining member and the receiving portion are coplanar in the initial configuration.
The foregoing and other features of the present disclosure will become apparent to one skilled in the art to which the present disclosure relates upon consideration of the following description of the disclosure with reference to the accompanying drawings, wherein:
Embodiments of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
With reference to
Storage device 100 may come in a variety of sizes and configuration, as discussed below, such that a number of tools and components may be retained therein. Solely for example, and not intended to be limiting, storage device 100 may be configured to retain such tools as, surgical staplers, tack appliers, reloadable fixation devices, vessel sealers, ablation probes, endoscopic instruments, trocars, biopsy needles, catheters, instrument coupling tools and corresponding fittings, or any other surgical device. Storage device 100 may additionally or alternatively be configured to retain such components as, for example, reloadable staple cartridges, reloadable tack cartridges, removable or interchangeable end effectors, surgical meshes, hypotubes, syringes, and any other surgical components. For the purposes of clarity, and for the sake of brevity, storage device 100 will be described herein with reference to a surgical stapler and counterpart components thereof, such as, a staple cartridge used with a reloadable surgical stapler. Storage device 100 additionally provides a localized position to retain any discarded tools or components, such as, for example, depleted reload cartridges, expended single use tools, or broken or defective tools, such that the tool or component is not reintroduced into the patient unintentionally. As staple cartridges are depleted and eventually replaced with a new staple cartridge, the depleted staple cartridges may be placed within storage device 100 such that depleted staple cartridges are kept at a localized position and the operator may visually assess the quantity of depleted staple cartridges, and thus more easily prevent a depleted staple cartridge from being reloaded into the stapler.
Storage device 100 defines a surface or receiving portion 10 configured to support the tool or component thereon and includes one or more retaining members 50. Each retaining member 50 is configured to permit the tool or component to pass through a thickness thereof (
As referenced above, retaining member 50 is transitionable between an initial configuration and the deployed configuration. In the initial configuration retaining member 50 is approximated to a surface 51 of receiving portion 10 such that a low profile is maintained and storage device 100 may be easy packaged in a compact and space saving fashion. In the deployed configuration, retaining member 50 is spaced away from a plane defined by the surface 51 of receiving portion 10 such that the surgical tool or component may be easily affixed thereto. Retaining member 50 may be substantially flush or coplanar with the surface 51 of receiving portion 10 in the initial configuration (
As illustrated in
Retaining member 50 further includes a securing region 53 disposed on the opposing major surfaces of retaining member 50, such that the thickness (not shown) of retaining member 50 is defined therebetween. It is contemplated that securing region 53 may be disposed on retaining member 50 such that an unbroken or solid boundary is created between securing region 53 and an outer perimeter of retaining member 50. In other words, securing region 53 is circumscribed by the material that forms the retaining member 50 or is defined by a contiguous or uninterrupted outer surface. Such a boundary may serve to increase the strength and resilience of securing region 53, such that a tool or component inserted therein is inhibited from tearing through, or ripping out of, retaining member 50. Securing region 53 defines a weakened or deformable portion of retaining member 50 which may be pre-cut or perforated, such that a tool or component “C” may be inserted therethrough, as seen in
Prior to the insertion of the component “C” through securing region 53, securing region 53 maintains a closed configuration (
With reference to
It is further contemplated that securing region 53, and/or perforated configuration 54a-h, may be configured to permit uni-directional insertion. In such an embodiment, component “C” may only be inserted through securing region 53 in the direction “I”, such that a major portion of component “C” which extends from securing region 53 is positioned over receiving portion 10, the benefits of which are discussed herein below with respect to receiving portion 10 and the retention of the tool, component, and/or biological waste thereon. It is further envisioned that securing region 53 may be configured to allow uni-directional translation of component “C” through retaining member 50. Once component “C” is inserted through securing region 53 in the direction of arrow “I” (
Storage device 100 may further include a raised edge, ridge, or lip 12 extending from an outer perimeter 14 of the receiving portions 10. Lip 12 is configured to prevent tools, components, and/or biological waste from unintentionally leaving receiving portion 10. Lip 12 may alternatively or additionally include a textured surface, such that a high friction perimeter is created around receiving portion 10 to further prevent the tools or components from leaving receiving portion 10. It is further contemplated that substantially all, or a part of, receiving portion 10 may include a textured, tacky, or adhesive surface to facilitate the retention of tools or components thereon. It should be appreciated that while lip 12 has been described and illustrated with respect to storage device 100, lip 12 may be utilized in a similar fashion with any of the storage devices disclosed herein.
With reference to
Retaining member 250 may be coupled to receiving portion 210 or may be monolithically formed therewith. It is envisioned that when transitioning between an initial configuration to a deployed configuration, retaining member 250 is bent, folded, or otherwise physically manipulated along crease 252. In the initial configuration, retaining member 250 is substantially planar with receiving portion 210 such that a low profile is maintained to promote compact and efficient packaging and storage within the operating theater. In the deployed configuration, retaining member 250 may be folded about crease 252 away from a plane defined by receiving portion 210 and into approximation therewith (
An attachment member 260 may extend from storage device 200 and serves to temporarily affix storage device 200 to the tool or component. Accordingly, storage device 200 may be temporarily affixed to, and/or packaged with, the tool or component when provided to the operator. In such an embodiment, storage device 200 is easily located by the operator when setting up the instrument or component for the procedure thus preventing storage device 200 from being misplaced or lost. Attachment member 260 may additionally be utilized to secure storage device 200 to a tray, table, or other location during the procedure, such that the location of storage device 200 is fixed within the operating theater.
Attachment member 260 may be flexible or partially-rigid and constructed from the same or differing materials as disclosed herein with respect to storage device 200. Attachment member 260 may further be monolithically formed with storage device 200 or may alternatively be coupled thereto by any known means in the art. Attachment member 260 may further come in a variety of forms, such as, for example, a suture, a tie-strap, a cable tie, an adhesive strip, a loop monolithically formed with storage device 200, a sleeve or sheath sized to slide over and receive a tool or component therein, a magnetic element adapted to adhere to a corresponding magnetic element of the tool or component, and/or any combination thereof. It is further envisioned that attachment member 260 may be disposed on, and/or extend from, any portion of storage device 200. With reference to
With reference to
With reference to
It is envisioned that storage device 400 may further include an enclosure 500 or an enclosure 550. Enclosures 500, 550 facilitate retention and affixation of used tools and components to receiving portion 410 of storage device 400. As illustrated in
It is further contemplated that receiving portions 10, 210, 310, and 410 of storage devices 100, 200, 300, and 400, respectively, may include one or more visual indicia disposed thereon to facilitate the accounting of tools or components used during the procedure. Visual indicia may include, for example, textural or color coded indicators, sequential punch holes, a section intended for operators to transcribe notes or comments thereon, or any combination thereof.
Storage devices 100, 200, 300, and 400 may be constructed from any suitable material to provide rigid support while also permitting storage devices 100, 200, 300, and 400 to transition into any of the configurations as described herein. Storage devices 100, 200, 300, and 400 may be made in whole, or in part, from a variety of materials, such as, for example, paper, pressed paper, cardboard, polymers, metals, metal alloys, or any combination thereof. It is contemplated that storage devices 100, 200, 300, and 400 may be further adapted to withstand sterilization through any known means in the art, such as, for example, steam sterilization, flash sterilization, ethylene oxide sterilization, or hydrogen peroxide gas plasma sterilization.
It is further envisioned that storage devices 100, 200, 300, and 400 may be made in whole, or in part, from absorbent materials, such as, for example, water-absorbing polymers or fiber-based products, and/or may include an absorbent coating thereon. Providing storage devices 100, 200, 300, and 400 with an absorbent element facilitates the collection and retention of biological material or waste which may be deposited thereon as a result of contact with used tools or components. It is envisioned that a used component may contain residual biological material or waste, such as blood, which may contaminate the surgical theater if permitted to freely come into contact with surrounding structures, tools, personnel, etc. With an absorbent element, storage devices 100, 200, 300, and 400 may thus facilitate a clean and sterile environment by absorbing such waste. It is further envisioned that storage devices 100, 200, 300, and 400 may contain absorbent portions configured to absorb biological material or waste and impermeable portions configured to resists the absorbance of liquids. In such a configuration, the cost of materials during manufacturing may be reduced, structural rigidity may be increased, unit weight may be reduced, packaging size and cost may be reduced, and/or any combination of the above.
With reference to
In use, storage device 100 is provided to an operator with retaining member 50 in the initial configuration. It is envisioned that a tool or component may be provided, such that storage device 100 is temporarily fixed to the tool or component. Storage device 100 may be provided in a sterilized package, independent of or together with, a sterilized tool or component, such that storage device 100 and the tool or component may be sterilized in a common packaging. With the storage device 100 removed from the packaging, and/or disconnected from the tool or component, retaining member 50 may be transitioned into the deployed configuration. It is envisioned that storage device 100 may be affixed to a specific location within the operating theater, such that movement of storage device 100 is inhibited. Storage device 100 is now ready to receive and affix the tool or component, or a plurality of tools or components, thereto.
As tools or components are unpacked, used, depleted, and/or replaced, the tool or component may be affixed to storage device 100, such that the operator may accurately account for the number of tools or components utilized during the procedure. For example, in a situation where the operator is aware that five staple cartridges were unpackaged and used during the procedure, five depleted staple cartridges should be affixed to storage device 100. Storage device 100 permits the operator to accurately compare the quantity of unpacked tools or components to the quantity of tools or components retained on storage device 100, and thus more confidently assess if a tool or component is unaccounted for.
With regard to storage devices 100 and 200, to affix component “C” to storage device 100, an end of the component “C” is put into abutment to securing region 53, such that the component “C” is insertable therethrough (
With reference to
A kit for storing a medical component in the operating theater using a storage device will now be discussed with reference to
Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/151,459 filed Apr. 23, 2015, the entire disclosure of which is incorporated by reference herein.
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