Patent Application
20150327604
This application claims priority to Canadian Patent Application No. (to be assigned) filed 6 May 2014 which application is herein expressly incorporated by reference.
The present invention relates to the field of protective garments such as surgical gowns and, in particular, to surgical gowns having one or more functional windows configured to allow the wearer to access and control accessory equipment under sterile conditions.
Creating and maintaining a sterile field is an essential component to reducing the risk of post-surgical infections in patients by decreasing the likelihood that infectious agents will invade the body during clinical procedures. A sterile field is an area created by placing sterile surgical drapes around the patient's surgical site and on the stand that will hold sterile instruments and other items needed during surgery. When a surgical team member has donned proper sterile surgical attire, such as a surgical gown, the surgical team member's sterile area is the only area that should come in contact with the sterile field. To maintain the sterile field, only sterile items should be placed within the sterile field and once a sterile object comes in contact with a non-sterile object, surface, or person, or with dust or other airborne particles, the object is no longer sterile and must be removed from the sterile field. Maintaining a sterile field is not an easy task as there are many opportunities for a breach in sterility during set-up and maintenance of the sterile area.
Technological advances in medical equipment has significantly changed the operating room environment. Medical equipment having a high level of technological complexity, introduced into the operating room, requires members of the surgical team to directly interface with these devices. This can be challenging in environments in which a sterile field must be maintained. Typically, a surgical team member may verbally direct a non-sterile member of the operating room team to control the equipment, or may use a sterile tool (such as a cotton swab) to directly push buttons on the surgical device. Alternatively, expensive voice activated equipment may be used to allow the sterile member to directly control the surgical equipment, for example Google Glass™. Overall, these methods tend to be costly, as well as imprecise, prone to error resulting from miscommunication or errors inherent to voice activated technology.
In addition to operating room conditions, persons of skill in the art will recognize other circumstances in which a sterile field may need to be maintained. In such circumstances, the need to maintain a sterile field can further restrict the ability of sterile members to operate equipment such as telecommunication devices (cell phones, tablets, computers) in order to access email and EMR charts, for example.
In addition to medical equipment, filming and recording devices are more frequently being found in operating rooms as filming and recording surgical procedures is now becoming more routine. Previously, such filming of surgical procedures was principally done for education within the hospital. Today, however, the need to film surgical procedures has expanded considerably. Cameras are used in operating rooms as a means of networking with the rest of the world. The camera has now become the vehicle by which surgeons can consult with each other during live procedures. For certain surgical procedures it is not uncommon for surgeons to consult with each other from different parts of the world during a case, commonly referred to as “telesurgery”. In teaching hospitals, clinical educators require interactive filming capabilities that can be controlled remotely from the classroom. Such procedures are either recorded for critique at a later date or simply observed “real time” for teaching. Surgeons routinely record procedures and edit the content for presentation at a conference. More surgical procedures are being recorded for future reference should the outcome of the surgery be questioned.
The ability of a surgeon to access and control such recording equipment without compromising the sterile field have been described. U.S. Pat. No. 6,899,442 describes a surgical theater system for mounting cameras, surgical lights, and monitors in the operating room. Such methods, however, do not provide a true “surgeon's view” of the surgical procedure, since the cameras are not necessarily facing the same direction as the surgeon.
Point of view (POV) cameras that can be mounted on head straps to provide a true “surgeon's view” during the operation have been developed. For example, International Patent Publication No. WO2009/063224 describes a headgear apparatus for mounting a camera on a surgeon's head. Despite the additional support provided by the described frame, the weight of the equipment, that in many cases must be held on the surgeon's head for long periods of time, places great stress on the neck and upper back leading to fatigue, headaches, stiff necks, muscular pain, and bruising. Eventually, there is the potential for prolapsed vertebrae to occur due to the surgeon supporting the weight of the head gear while looking down for extended periods of time into the surgical field. In addition, head movement during the surgical procedure can result in excessive camera shake and a poor surgical video.
The introduction of technologically sophisticated equipment in the operating room, and the demand for this equipment to be directly operable by surgical staff in a seamless and user-friendly fashion, while maintaining the sterile field, presents an ongoing need.
This background information is provided for the purpose of making known information believed by the applicant to be of possible relevance to the present invention. No admission is necessarily intended, nor should be construed, that any of the preceding information constitutes prior art against the present invention.
An object of the present disclosure is to provide a surgical gown with one or more functional windows configured to allow the wearer to access and control accessory equipment under sterile conditions. In accordance with one aspect, there is described a surgical gown for protecting a wearer and maintaining a sterile field, comprising one or more flexible and transparent windows disposed in the gown to allow the wearer to directly interface in a sterile manner through the one or more windows with a device attached to the wearer underneath the gown.
In accordance with another aspect, there is described a surgical gown for protecting a wearer and maintaining a sterile field, the surgical gown comprising a pair of sleeves and one or more flexible and transparent windows disposed in one or both sleeves of the gown, whereby the wearer can view the device and directly interface with the device in a sterile manner through the one or more windows, the device being attached to the arm of the wearer underneath the gown.
In accordance with a further aspect, there is described a surgical gown for protecting a wearer and maintaining a sterile field, the surgical gown comprising a front body portion and a flexible and transparent window centrally disposed on the front body portion of the gown, the window sized to accommodate a camera, or video, or optical recording device attached to the wearer's chest, wherein the wearer can directly interface with the camera in a sterile manner to film or record a procedure through the window centrally disposed on the front body portion of the gown.
These and other features of the invention will become more apparent in the following detailed description in which reference is made to the appended drawings.
Protective garments, such as surgical gowns, designed to provide barrier protection are well known in the art. In the medical industry in particular, surgical gowns play a dual role of providing a protective barrier to the wearer as well as maintaining a sterile field to protect the patient from infection. Surgical gowns are made to cover the front and back torso and the arms of the wearer to protect the wearer from coming into contact with bodily fluids during surgical procedures such as blood, plasma, serum, and other liquids. Additionally, the surgical gowns are made sterile and are intended to prevent the possibility of infection being transmitted from the wearer to the patient. In this way, the surgical gown plays an integral part in maintaining the sterile field.
The surgical gown according to embodiments of the present disclosure provides the dual function of protecting the wearer while maintaining the sterile field, and further offers the wearer the ability to directly access and interface with technological equipment being operated during a surgical procedure. According to embodiments of the present disclosure, the surgical gown comprises one or more functional windows positioned on the gown to allow the wearer to interface in a sterile manner with a device attached to the wearer underneath the gown. The surgical gown according to embodiments of the present disclosure provides the dual function of protecting the wearer while maintaining the sterile field, and further offers the wearer the ability to directly access and interface with technological equipment being operated during a surgical procedure. According to embodiments of the present disclosure, the surgical gown comprises one or more functional windows positioned on the gown to allow the wearer to interface in a sterile manner with a device attached to the wearer underneath the gown. The functional window(s) is located on the gown to allow the wearer to easily view and actuate operation of the device, for example, by directly depressing control buttons or a touchscreen display, through the functional window(s). In this regard, the functional window(s) is positioned on the gown in locations that allow convenient and comfortable access by the wearer. For example, according to certain embodiments, the functional window(s) is located on the sleeve of the gown to allow the wearer direct access and/or control of a device that is attached to the wearer's arm directly underneath the functional window(s). According to such embodiments, the windows are positioned above the elbow area of the gown in order to maintain sterility therebelow after a surgeon has scrubbed their arms below the elbow, prior to donning the surgical gown. In this way, maintenance of the sterile field is ensured.
In other embodiments, the functional window(s) is located on the front body of the gown to allow the wearer direct access and/or control of a device that is attached to the wearer's chest directly underneath the functional window(s). In further embodiments, the surgical gown comprises multiple functional windows that can include one or more functional window(s) located on one or each sleeve and/or a functional window located on the front body of the gown. In this way, the wearer has access to multiple devices and/or control systems.
According to embodiments of the present disclosure, the functional window is transparent to allow clear visibility of the device and/or controls positioned underneath. The functional window is further flexible to allow tactile interfacing by the wearer thereby offering the wearer direct control over the connected device. According to certain embodiments, the functional window is made of a pliable or flexible material to allow the operation of physical buttons by the wearer. In other embodiments, the functional window is heat conductive to allow operation of a touchscreen display. In further embodiments, the window's transparency allows devices having biometric systems to be used. For example, retinal or iris identity verification and eye tracking technology for accessing and controlling the technological device that may be operational in combination with a holographic computer display on the users glasses, surgical scope, or loupes.
According to a further embodiment, the functional window is adapted to house a filming or recording device, such as a camera. In such embodiments, the functional window may be centrally located on the body of the gown approximately in the chest area of the wearer to allow the wearer to directly operate a camera attached to the wearer's chest underneath the functional window. By allowing the wearer to access and directly control a camera from the chest position a “surgeon's view” of a procedure is provided while avoiding the health hazards associated with known head mounted cameras. In addition to being more comfortable for the wearer, chest-mounting of a camera provides greater stability resulting in less movement of the camera and a better quality surgical recording. According to such embodiments, the functional window can be further adapted to be outwardly extendable in order to accommodate a variety of camera and lens positions. For example, the lens may be extendable to zoom in and out from the wearer's chest. In other embodiments, the camera may be mounted on an extendable mount attached to the wearer's chest.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
As used herein, the term “disposable” describes articles that are not intended to be restored or reused and which are intended to be discarded after a single use.
As used herein, the term “camera” and “video recording device” are used interchangeably to refer to any electronic device that captures, films, records, and/or transmits pictures, videos, movies, films, photographs, or other visual images digitally, on film, or in any other form or medium.
As used herein, the term “about” refers to an approximately +/−10% variation from a given value. It is to be understood that such a variation is always included in any given value provided herein, whether or not it is specifically referred to.
Embodiments of the present disclosure will now be described by reference to
Referring to
It should be appreciated that the type of fabric or material used for the surgical gown 10 is not a limiting factor of the invention. The surgical gown 10 may be made from a multitude of materials commonly used for surgical gowns. Moreover, although it is contemplated that the embodiments of the surgical gown 10 shown and described herein may be disposable, in particular embodiments, the surgical gown 10 is sterilizable, to facilitate re-use.
For example, materials that may be suitable for various embodiments of the surgical gown 10 include woven or non-woven laminates, barrier composites, and barrier fabrics including multilayer nonwoven laminates suitable for disposable use.
Windows 20, 60 may be fabricated from any one or more materials, which are substantially transparent and flexible, and capable of meeting the barrier performance standards required to maintain a sterile field. Examples of potentially suitable materials include polymeric (plastic) materials, e.g., thermoplastic or thermosetting polymers of high molecular weight and that can be made into sheets. In further embodiments, the windows 20, 60 comprise polymers such as polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and combinations or mixtures thereof. According to certain embodiments, the windows 20, 60 are fabricated such that interfacing with a touchscreen display is not impaired by the windows 20, 60. According to certain embodiments, the materials are heat conductive for example to facilitate interaction with a touchscreen display through the windows 20, 60. In further embodiments, the materials are sufficiently transparent to allow devices having biometric systems to be used. For example, biometric systems such as retinal or iris identity verification and eye tracking technology for accessing and controlling the technological device that may be operational in combination with a holographic computer display on the users glasses, surgical scope, or loupes.
As mentioned above, in certain embodiments, the windows 20, 60 are fabricated from a material that is capable of being sterilized by sterilization techniques commonly used in hospitals and other medical facilities. Examples of sterilization techniques usable with the various embodiments discussed herein, include high temperature steam, gas sterilization including those using Ethylene Oxide (EtO) gas, formaldehyde gas, or ozone gas, dry heat, microwaves, hydrogen peroxide plasma, ionizing radiation, and various chemical solutions known in the art.
Windows 20, 60 are disposed in the surgical gown 10 in a secure manner with a seal that meets or exceeds the barrier performance standards required to maintain the sterile field.
For example, a suitable seal may be provided by heat fusion, ultrasonic welding, chemical adhesives, and/or combinations thereof, depending on the particular materials used for the surgical gown 10 and windows 20, 60.
Sterile Interface—Arm-Attached Device and/or Controls
According to a particular embodiment of the present disclosure, as shown in
The dimensions of the windows will depend on where in the surgical gown 10 the windows are located. According to the embodiment shown in
According to the embodiment shown in
Moreover, while in the embodiments shown, window 20 is generally rectangular, the skilled artisan should recognize that the window 20 may be of substantially any convenient size and shape, including circular, oval, trapezoidal, and/or other polygonal or ovoid shapes, etc., suitable for enabling a wearer to view and directly interface with a device attached to the wearer's arm underneath the surgical gown 10 and beneath the window 20. Still further, the window 20 may be a single window 20, as shown disposed in each sleeve 30, or by a series of smaller windows 20 disposed in spaced relation to one another, without departing from the scope of the present invention.
It is contemplated that windows 20 similar to the embodiments shown in
It is further contemplated that surgical gowns 10 of the present disclosure can comprise any combination of windows disposed in the sleeves 30 and/or the frontal body portion 40.
Referring to
The window 60, in such embodiments, is of an ultra-clear optical quality to avoid compromising the quality of the photos, filming and/or recording taken through the window 60. A variety of known optically clear materials are known in the art and can include polymeric (plastic) materials, e.g., thermoplastic or thermosetting polymers. In further embodiments, the windows 20, 60 comprise polymers such as polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and combinations or mixtures thereof. One such commercially known material includes Lenzflex™.
According to further embodiments, the window 60 can be further adapted to be outwardly extendable to varying distances away from the wearer's chest in order to accommodate a variety of camera and lens positions. For example, the lens may be extendable to zoom in and out from the wearer's chest. In other embodiments, the camera 70 may be mounted on an extendable mount attached to the wearer's chest underneath the surgical gown 10. As more clearly shown in
The window 60 can further be adapted with securing means for holding the camera in place. Substantially any type of releasable fasteners may be used, including mechanical and chemical fasteners such as mechanical snaps, ties, and/or adhesives. In particular embodiments, the releasable fasteners 80 include conventional hook and loop fasteners, e.g., VELCRO™ fasteners (Velcro Industries B.V.).
It should be appreciated that, although the present invention has particular usefulness as a surgical gown, the invention is not limited in scope to surgical gowns or the medical industry. The protective garment according to the present invention has wide application and can be used in any instance wherein a protective coverall, gown, robe, etc., is used. All such uses and garments are contemplated within the scope of the invention.
It is contemplated that any embodiment discussed herein can be implemented with respect to any method or composition of the invention, and vice versa. Furthermore, compositions and kits of the invention can be used to achieve methods of the invention.
The disclosures of all patents, patent applications, publications and database entries referenced in this specification are hereby specifically incorporated by reference in their entirety to the same extent as if each such individual patent, patent application, publication and database entry were specifically and individually indicated to be incorporated by reference.
Although the invention has been described with reference to certain specific embodiments, various modifications thereof will be apparent to those skilled in the art without departing from the spirit and scope of the invention. All such modifications as would be apparent to one skilled in the art are intended to be included within the scope of the following claims.
