CN107106256A - Sterile barriers for surgical light heads - Google Patents

Abstract

An infection mitigation device that provides a temporary disposable sterile barrier between the sterile field of a surgical lighthead and the non-sterile lighted area. The protective barrier can be easily applied and removed by a surgical team member when needed. The device minimizes the possibility of biohazardous material being transmitted between patients, thereby reducing the chance of infection and ultimately providing improved clinical outcomes to the patients. The central region of the barrier may be adapted to receive and/or cover (partially or completely) one or more types of centrally located surgical lighthead adjustment handles. The device may be fabricated using a single structure or a composite structure. Depending on the specific composition of the barrier and the application, the support carrier means may provide additional geometric stability to the barrier when the barrier is manipulated into its operational position on the lamp head. The device can be configured to be compatible with all surgical lightheads and non-OEM retrofit disposable handle systems.

Description

Sterile barriers for surgical light heads

Josie Bates and Paul Weatherspout Scott IV

Cross References to Related Applications

This application claims the benefit of US Provisional Application No. 62/056,671, filed October 19, 2014, the entire contents of which are incorporated herein by reference.

technical field

The disclosed devices and methods relate to overhead surgical lighting systems, and more particularly to disposable temporary sterile barriers that shield their forward-facing areas from potentially biohazardous contamination.

Background technique

Healthcare-associated infection (HAI) is a significant cause of morbidity and mortality in medical centers around the world. In 2007, the U.S. Centers for Disease Control and Prevention (CDC) estimated the number of surgical site infections in U.S. hospitals to be approximately 300,000 cases, where the total annual direct medical cost of HAI in U.S. hospitals is estimated to be approximately $30 billion.

In modern operating rooms, large overhead light heads are often used to illuminate the surgical site. These light heads are usually suspended from the ceiling, wall or in some cases attached to a mobile floor frame. The lamp head itself typically has a large forward-facing area where the illumination from the light source exits through the window.

Many surgical light heads include an adjustment handle that can be located in the center of the aforementioned window. This handle provides the surgeon or surgical assistant with the ability to position the overhead light and aim it at the patient's area of interest. To avoid unnecessary confusion and save time, the surgeon can operate the surgical light by himself/herself. Because this handle is always covered by a disposable protective cover during surgery, it is usually the only area of the surgical light head that is considered sterile. To keep costs down, some medical centers use non-OEM handle covers purchased from third parties. These third party cap systems typically require an adapter provided by the handle cap supplier to be mounted to the surgical light head to accommodate the cap.

In many procedures, an open surgical site (wound) provides an opportunity for biological and potential biological hazards to leave the patient and contaminate nearby equipment in the operating room. Similarly, patients with open surgical sites are at risk of receiving potential biohazards from equipment that has been contaminated during previous surgeries. Some procedures require the use of powered, high-impact surgical instruments that are particularly effective at aerosolizing or otherwise imparting large amounts of kinetic energy to biological material. Under these circumstances, biological contaminants can readily reach and adhere to exposed, often non-sterile surfaces of the surgical light head. These previously applied contaminants can later fall from the device into other patients' open surgical sites. Infections from receiving patients can be fatal.

As previously mentioned, the area of the window area of the surgical light head can be very large and is also the face directed towards the surgical site. Accordingly, the forward-facing area of the light head is prone to contamination by biological material ejected from the surgical site. Surgical light heads are also one of the few devices that can be placed directly over a patient's surgical site, so they are especially well placed to allow biohazardous contamination to fall into an open wound or to contaminate autologous material expelled from a patient that could fall into an open wound Moderate risk, and thus presents a high risk of infection to the patient.

Additionally, the large, forward-facing area of the lamp head is a major target for surgeons or any surgical personnel to inadvertently contaminate their gloves or other clothing during surgery. This contamination can occur when reaching for the lamp handle, manipulating the lamp or even by brushing the lamp unknowingly. If surgical members are unaware that they have been contaminated, the patient's risk of infection can be dramatically increased.

Surprisingly, the front-facing luminous area of the surgical light head is usually not covered or protected from contamination. Although these surfaces are occasionally wiped down by surgical technologists according to the specific cleaning protocol of the medical center, they are never considered sterile and are often contaminated between patients. To date, the only area of the surgical light head that is generally protected from contamination is the handle used by the surgical staff to manipulate the physical position and/or control certain functions of the light.

Accordingly, there is a need for a disposable, temporary sterile barrier or shield that protects the illuminated or forward-facing area of the surgical light head. Replacing this shield, including but not limited to between procedures, minimizes the possibility of surgical light heads spreading potentially biohazardous contaminants between patients, thereby improving their clinical outcome.

Contents of the invention

An infection mitigation device that provides a temporary disposable sterile barrier between a sterile site of a surgical light head and a non-sterile, light-emitting area is disclosed. The protective barrier can be easily applied and removed from the lamp head between each procedure. The device minimizes the possibility of biohazardous material being transmitted between patients, thereby reducing the chance of infection and ultimately providing improved clinical outcomes for patients.

The barrier device can be configured to suitably fit all lamp head models from all manufacturers. While many manufacturers produce round lamp caps, the barrier device may be adapted to fit lamp caps of any shape including, but not limited to, square, rectangular, hexagonal, and oval. The device may be configured to partially or completely cover the forward facing light emitting area of the lamp head and extend well beyond this area to provide coverage for the sides and any non-sterile peripheral surfaces.

The barrier means may consist of one or more types of translucent or transparent films. Depending on the attachment used and the method of manufacture, adhesives may be used to assemble and/or attach the membrane to the lamp cap.

The surgical light head may be configured with a positioning handle and/or a control handle located in the central region of the window through which light is emitted. This handle can provide the surgeon or surgical assistant with the ability to position the overhead light and aim it at the patient's area of interest, and sometimes access to other controls such as brightness and focus. The handle can be sterile and can be covered with a disposable cover during surgery. The protective barrier devices disclosed herein may also be adapted to receive (partially or completely) and/or cover one or more types of centrally located surgical light head adjustment handles. Where existing central handles are configured with a camera, the barrier device may also be adapted to cover those exposed surfaces at the manufacturer or at the point of use.

While the barrier can be adhered to the lamp head using conventional adhesives, static attachment effects can also be used. The barrier may also be attached by mechanical fixing, wherein the central handle and/or the outer edge of the lamp head provide the means of fixing the device. Constructing the barrier such that the shape provides overall geometric stability allows for a much smaller attachment area than a flat device. When the device is configured to be attached with adhesives, those adhesives may be selectively exposed or placed instead of covering the entire surface. For example, installation and/or handling difficulties may be minimized by configuring the device to have no adhesive in the area where the device is held. Adhesive locations can also be configured to attach only in specific areas rather than over large areas, improving ease of installation.

To keep costs down, some medical centers use non-OEM handle covers purchased from third parties. These third party cap systems often require an adapter to be mounted to the surgical light head to accommodate the cap. The protective barrier devices disclosed herein may be adapted to be received and/or mounted to said adapter.

Devices can be fabricated using a single structure or a composite structure. For example, one or more methods of integral reinforcement may be utilized to provide geometric stability when the barrier is positioned on the lamp head. This can include laminating together two or more layers of shaped or non-shaped material or by incorporating various combinations of different materials such as metals, plastics, ceramics, fibers, fabrics, or combinations thereof.

When the support carrier device is maneuvered into its functional position on the lamp cap, it can provide the barrier with additional geometric stability. The carrier portion can be independent or separate from the barrier device.

The device can also be constructed as a laminated set of multiple disposable layers. The laminated set can be applied to the light head and the exposed layers can then be removed and disposed of as needed, including but not limited to between procedures.

Description of drawings

1 is a perspective view of a variation of a method of applying a sterile barrier with a feathered center to a surgical light head.

Figure 2 is a perspective exploded view of a variation of the sterile barrier with a circular central disposable handle cover and a light head with a standard handle.

Figure 3a is a perspective view of a variant of the method of removing a sterile barrier with a collapsible center from a lamp cap with a disposable handle cover.

Figure 3b is a close up view of a variant of Figure 3a.

4 is a perspective view of a variation of a sterile barrier with a feathered center applied to a surgical light head with a camera handle.

Figure 5 is a perspective view of a variation of the sterile barrier with an integrated handle cover.

Figure 6a is a perspective view of a variant of the sterile barrier with an integrated camera handle cover in the area of the control junction.

Figure 6b is a close up view of a variant of Figure 6a.

7a and 7b are exploded perspective and side views, respectively, of a variation of a tapered sterile barrier configured as a retrofit camera cover.

Figure 7a' is a close up view of a variation of Figure 7a.

Figure 7c is a perspective view of a variation of a tapered sterile barrier with a collapsible center configured as a retrofit camera cover.

Figure 7c' is a close-up view of a variation of cross-section A-A of Figure 7c.

8a and 8b are exploded perspective and side views, respectively, of a variation of a tapered sterile barrier configured to retrofit a rigid handle.

9a and 9b are exploded perspective and side views, respectively, of a variation of a tapered sterile barrier configured to retrofit a flexible handle cover.

Figure 10 is an exploded perspective view of a variation of the multi-layer peelable lid system.

Figure 11a is a perspective view of a variation of a sterile barrier with thread reinforcement.

Fig. 11a' is a close-up view of a variation of Fig. 11b.

Figure lib is a perspective view of a variant of the sterile barrier with shaped plastic film reinforcement.

Fig. 11b' is a close-up view of a variation of Fig. 11b.

Figure 11c is a perspective view of a variant of the sterile barrier with flat plastic film reinforcement.

Figure 12 is a perspective view of a variation of the method of using a sterile barrier with a mounting support carrier.

Figures 13a-13e are perspective views of variations of the sterile barrier with exposed adhesive in different positions.

Figure 14a is a perspective view of a variant of a tapered sterile barrier without holes and without a handle on the light emitting window of the lamp head.

Figure 14b is a perspective view of a variant of a flat sterile barrier without holes and without handles on the light emitting window of the lamp head.

reference sign

001: Surgical lamp head assembly

002: Surgical light head window

003: Standard handle for surgical light heads

004: Camera handle for surgical lamp head

005: Disposable sterile caps for standard handles

006: Disposable sterile cover for camera handle

007: Retrofit Adapter for Standard Handle - Rigid

008: Retrofit Adapter for Standard Handle - Flexible

009: Retrofit adapter for camera handle

010: Disposable rigid modified handle

011: Disposable flexible sterile cap for retrofit handle adapter

012: Disposable rigid modified camera sterile cover

013: Surgical lamp support arm

014: Surgical Lamp Head Auxiliary Handle

015: Surgical light head window - no handle

100: Sterile Barrier - Plume Center

105: Sterile Barrier - Round Center

110: Sterile Barrier - Collapsible Center

115: Sterile Barrier - Integrated Handle Cover

120: Sterile Barrier - Integrated Camera Handle Cover with Control Joint Area

125: Sterile Barrier - Modified Camera Handle

130: Sterile Barrier - Modified Rigid Handle

135: Sterile Barrier - Modified Flexible Handle

140: Sterile Barrier - Collapsible - Modified Camera Handle

141: Sterile Barrier - Non-Porous - Conical

142: Sterile Barrier - Non-Porous - Flat

143: Sterile Barrier - Line Reinforcement

145: Exposed adhesive location

150: peeled slices

155: Line Reinforcement Department

160: flat reinforcement

165: Shaped reinforcement layer

170: reinforced rib

175: foldable pleats

180: feathered edge

185: Head control junction area

190: Overlap Laminated Edges

195: Integrated camera handle cover

200: Multilayer sterile barrier system

205a: Peelable layers of multilayer sterile barrier systems

205b: Peelable layers of multilayer sterile barrier systems

205c: Peelable layers of multilayer sterile barrier systems

205d: Peelable layers of multilayer sterile barrier systems

300: Install the supporting bearing part

400: Arrow - Peel off sterile barrier to separate from lamp head

405: Arrows - Elimination of sterile barriers for processing

410: Arrow - Sterile Barrier Installation

detailed description

Figure 1 illustrates that a sterile protective barrier device 100 (also referred to herein as a barrier) can be attached to a universal surgical light head assembly 001 (also referred to herein as a surgical light head) as indicated by the arrows. The surgical light head assembly may have a light source and a light emitting window 002 through which light from the light source passes when the light source emits light. The light emitting window may be circular but also rectangular, square, triangular, hexagonal, oval or any combination thereof. A sterile protective barrier device (eg, 100 ) can be configured to match or extend across the perimeter, periphery, circumference, or outer diameter of the light emitting window and/or surgical light head assembly.

Referring to Fig. 2, the surgical light head can be suspended using the support arm 013, or it can also be mounted to a mobile floor stand, wall or other equipment close to the light head. The surgical light head may have a standard handle 003 extending from the light emitting window 002. A standard handle may be located in the center of the light emitting window 002 and extend vertically from the light emitting window 002 . The standard handle 003 can be fully or partially covered by a disposable sterile handle cover 005 . One or more cameras 004 may extend through the standard handle 003 as shown in FIGS. 7 a and 10 . As shown in FIGS. 4 and 10 , the camera 004 may also be covered by a disposable sterile cover 006 . As shown in FIG. 2 , the surgical light head can have an auxiliary handle 014 that can extend radially from the surgical light head assembly 001 . The sterile protective barrier device may have one or more release sheets 150 . The sterile protective barrier can be fabricated by one or more of a number of commercially available techniques such as thermoforming, die-cutting, adhesives, and/or heat-melting.

central variant

A sterile protective barrier (eg 100-140, 200) can cover the standard handle 003 and/or the camera handle 004. Figure 2 discloses a sterile barrier 105 with a circular center. FIG. 3 discloses a sterile barrier 110 having a hinged collapsible center 175 . FIG. 4 discloses a feathered central sterile barrier 100 having a feathered edge 180 . Figure 5 discloses a sterile barrier 115 with an integrated handle cover. FIG. 6 discloses a sterile barrier 120 with an integrated camera handle cover 195 , where the cover may be configured with a controlled access area 185 . The features described above may be fabricated by one or more of a number of commercially available techniques including, but not limited to, vacuum forming, die cutting, adhesives, and/or heat melting. For example, the handle/camera cover geometry can be thermoformed as an integral feature of the sterile barrier device, or it can be fabricated separately and subsequently glued/fused together. Figures 14a and 14b disclose a surgical light head without a standard handle on the light emitting window 015. FIG. 14a discloses a tapered barrier variant 141 and FIG. 14b discloses a flat barrier variant 142 . Variations 141 and 142 without holes may be attached to light head 001 by adhesives, fasteners and/or clips.

Modding Tool Compatibility

Surgical light head 001 may be configured with an aftermarket, non-OEM retrofit handle cover system as shown in Figures 7a, 8a and 9a. These third-party cap systems typically require adapters (eg, 009, 007, or 008, respectively) to fit to the surgical light head to accommodate standardized disposable caps (eg, 005, 006, 011, or 012) or disposable handles (eg, 010). The protective barrier devices disclosed herein may be adapted to be received and/or mounted to said adapter. FIG. 7 a discloses a disposable barrier 125 configured to be compatible with the camera handle 004 , retrofit adapter 009 and disposable camera cover 012 . The retrofit systems shown in FIGS. 9 a and 9 b (eg 007 , 008 , 009 , 010 and 012 ) may have a thin, flexible, disposable handle cover 011 (not shown) and a flexible retrofit handle adapter 008 . The barrier (eg 125, 130, 135 or 140) may be tapered or partially tapered. The disposable handle cover 011 can be slid onto the flexible retrofit handle adapter 008. Sterile barrier 135 includes a flexible handle cover that extends radially beyond handle 008 to also form a sterile barrier for light head window 002 . Disposable barrier 135 and variations thereof may be fabricated by one or more of a number of commercially available techniques such as thermoforming, die cutting, adhesives, and/or heat melting. Figures 7a' and 7b show that the overlapping edges 190 (ie, the two opening edges) of the disposable barrier 125 manufactured by die cutting can then be attached together to form a self-supporting form.

Figures 7c and 7c' disclose a disposable barrier 140 having hinged coaxially foldable corrugations, corrugations or convolutions 175 . Figures 8a and 8b disclose a disposable barrier 130 configured to be compatible with the disposable rigid retrofit handle 010 and retrofit adapter 007. Similar to the barrier devices 125 and 140 disclosed above for retrofit camera covers, the barrier 130 may be held by a disposable handle. Also similar to barrier 125 , barrier 130 may have foldable corrugations, corrugations or convolutions 175 . FIGS. 9 a and 9 b disclose a disposable barrier 135 configured to be compatible with the disposable flexible retrofit handle adapter 008 . Similar to the barrier devices 125 and 130 disclosed above, the barrier 135 can be retained by the retrofit adapter 008 (ie, to the surgical light head), and can also be configured with a collapsible convolution 175 .

Multilayer Peelable Barrier

Figure 10 discloses a multilayer laminate sterile barrier system 200 comprising a plurality of peelable layers 205a, 205b, 205c and 205d.

barrier reinforcement

Figures 11a, 11a', 11b, 11b' and 11c disclose integrated reinforcement variations for sterile barrier devices. Figures 11a and 11a' disclose an embodiment of the thread reinforcement 155. These wire reinforcements may be formed, molded and/or welded. In a variant, as disclosed in the detailed view of FIG. 11 a , the barrier 143 has an overlap 190 on the wire reinforcement 155 that retains the barrier 105 . The wire reinforcement may also be attached directly using other methods including tape or heat staking. FIGS. 11 b and 11 b ′ disclose an embodiment of a secondary layer of formed plastic film 165 with reinforcing ridges or features 170 laminated to the primary barrier layer 143 . Depending on various factors such as material type and geometry, the shaping layer 165 may be sufficiently stabilized such that a separate barrier layer 143 is not required. Reinforcement features 170 may also be multiple smaller subcomponents attached to specific regions of barrier layer 143 . FIG. 11c discloses an embodiment of a flat reinforcing material 160 applied to the sterile barrier 105 .

Install the supporting part

Figure 12 discloses a support device 300 that carries or stabilizes the sterile barrier 105 until said barrier is attached to the light head. The support means can be manufactured from a wide range of transparent/translucent and opaque materials.

adhesive variant

Figures 13a-13e disclose variations for applications requiring adhesives. Barrier 105 may have a barrier film with exposed adhesive in location 145 . One or more release sheets 150 may be placed in different directions extending from the circumference of barrier 105 . For example, the barrier 105 may have a single release sheet 150 (as shown in Figures 13a and 13b), four release sheets 150 spread out from each other at 90 degrees with two sets of diametrically opposed release sheets 150 (as shown in Figure 13c). ), three release sheets 150 (as shown in FIG. 13d ), two release sheets diametrically opposed to each other (as shown in FIG. 13e ), or overlapping combinations thereof. The adhesive can be applied to selected portions or the entire surface of the barrier film. Barrier 150 may then be laminated with another film configured to expose only adhesive locations 145 as desired. Adhesive type and location selection may be based on a number of factors including providing adequate adhesion, ease of installation and removal, and minimizing or eliminating any residue remaining on the light head after removal. Some areas of the disposable barrier 105 (eg, the release sheet 150 ) may be configured without adhesive to minimize the possibility of unwanted attachment of the gloved hand of the user operating the device. Conventional adhesives, as well as many other attachment means such as magnets, elastic bands, friction, Velcro, electrostatic attachment, suction, mechanical fasteners, or combinations thereof, may be attached to the barrier film at location 145 . Non-planar or tapered sterile barriers may use adhesives as an attachment method.

material variant

The protective barrier device may be composed of one or more types of transparent or translucent materials including, but not limited to: polyethylene terephthalate (PET), polyester (PE), polycarbonate (PC) , polymethyl methacrylate (PMMA), polystyrene (PS), polyurethane (PUR and PU), copolyester (PETG), fluorinated ethylene propylene (FEP), perfluoroalkoxy polymer (PFA) , polytetrafluoroethylene (Teflon), polychlorotrifluoroethylene (PCTFE or PTFCE), biaxially oriented polyethylene terephthalate (BoPET), biaxially oriented polyethylene naphthalate ( PEN), cellulose acetate (CA), styrene acrylonitrile (SAN), polyphenylsulfone (PPSU), polyetheretherketone (PEEK), polyimide (PI), polysulfone (PSU) or combinations thereof.

Protective barriers can pass or absorb specific wavelengths or bands of radiation within or outside the visual spectrum. Other non-translucent/transparent materials may be suitable for areas where light transmission is not desired. For example, reinforcing materials may include metal alloys, reinforcing fibers, composite materials, plastics, resins, paper products, and combinations thereof.

operate

Figure 1 discloses a sterile protective barrier device 100 applied to an exposed non-sterile surface of a surgical light head 001, eg, to prevent potentially biohazardous contamination. One of the surgical personnel can apply the sterile barrier device (e.g., 100) to the light head 001 prior to the procedure, and then, as shown in FIG. 001 to remove (as shown by arrow 400) and dispose of the sterile barrier device (eg, 100). Referring to FIG. 2 , illumination may be emitted from window 002 . Because this area usually points in the direction of the surgical site, it is also one of the areas with the greatest risk of contamination. Partly due to the proximity of this window surface to the lamp head positioning handle 003, it is also at risk of inadvertent touch by the operator. The surgical light head may have a camera 004 (FIG. 7a) instead of the standard light head positioning handle 003. However, the camera can still be used to position and control light heads and/or camera functions. Some surgical light heads may have auxiliary handles 014, but they are generally neither covered by a sterile barrier nor intentionally touched during surgery.

central variant

As shown in Figure 2, the surgical light head may have a centrally located positioning/control handle 003. As shown in Figures 7a and 10, the handle 003 may have or may be a video camera. As shown in FIG. 6 , during a surgical procedure, the surgical staff and/or surgeon may use the handle to position the surgical light head 001 and achieve some or all control of the light and/or camera 004 . These non-sterile handles can be covered by disposable sterile caps 005 and/or 006 (Figures 2 and 10) to minimize the possibility of transfer of biological contamination between patients.

The sterile protective barrier (eg, 100 ) can be configured to accommodate or cover many variations of the standard handle 003 and camera handle 004 . Figure 2 discloses a sterile barrier 105 with a circular cutout center. Figure 3 discloses a sterile barrier 110 with a hinged foldable center 175 which can improve compatibility between different lamp head models and sizes by allowing the hinge in the area where the sterile barrier device engages with the disposable handle cover 005 or 006. Geometry Compatibility. Figure 4 discloses a feathered central sterile barrier 100 with a feathered edge 180 that can improve the geometric compatibility between the sterile barrier and the disposable handle cover 005 or 006. Figure 5 discloses a sterile barrier with an integrated handle cover 115 which can minimize the risk of contaminants damaging the joint between the disposable handle covers 005 or 006 and the steps required to prepare the lamp head for surgery. Fig. 6 discloses a sterile barrier with an integrated camera handle cover 120, wherein the cover may be configured to have a region 185 of the camera control interface disposed proximate to or beneath the light head.

Modding Tool Compatibility

To reduce cost and provide broader cross-compatibility, surgical light head 001 can be configured with an aftermarket, non-OEM handle cover system as shown in Figures 7a, 8a and 9a. These third-party handle cover systems typically require an adapter (such as Adapter 009, 007 or 008, respectively) to be removably or detachably mounted to a standard light head handle 003 or a camera light head handle 004 to accommodate standardized disposable covers (such as , 005, 006, 011 or 012) or a disposable handle (such as 010). The protective barrier devices disclosed herein may be adapted to be received and/or mounted to the adapter with and without the use of disposable caps or handles provided by third parties. FIGS. 7 a , 7 b and 7 c disclose a disposable barrier 125 configured to be compatible with the camera handle 004 , retrofit adapter 009 and disposable rigid camera cover 012 . The form of the barrier (eg 125, 130, 135, 140) may be tapered or partially tapered to provide overall geometric stability during and while installed and to accommodate retrofit adapters (eg adapters 009, 007 or 008).

With a retrofit system using a rigid disposable like the cap 012 or handle 010 ( FIGS. 7 a and 8 a ), the sterile barrier 125 or 130 can be attached to the cap and then screwed into a retrofit similar to the adapter 007 or 009 in the adapter. Once the procedure is complete, the device 010 or 012 can be unscrewed, allowing the sterile barrier 125 or 130 to be removed with subsequent processing of both the sterile barrier and the handle cover. Figure 7c discloses a disposable barrier 140 with foldable convolutions 175 to accommodate a wider range of fitting variations between lamp head models and sizes.

Figures 8a and 8b disclose a disposable barrier 130 configured to be compatible with the disposable rigid retrofit handle 010 and retrofit adapter 007. Similar to the barrier device 125 disclosed above for retrofit camera covers, the barrier 130 can be held by a disposable handle, and the shape of the barrier inherent to the three-dimensional geometry provides overall stability. Also similar to barrier 125, barrier 130 may also be configured with foldable convolutions 175 to provide a wider range of light head compatibility. FIGS. 9 a and 9 b disclose a disposable barrier 135 configured to be compatible with the disposable flexible retrofit handle adapter 008 . The retrofit system is typically provided with a thin, flexible, disposable handle cover 011 (not shown). The barrier device 135 may be retained by friction at the interface between itself and the flexible handle cover adapter 008 . When the lamp needs to be configured with a sterile barrier, the barrier device 135 can be slid onto the cap adapter 008 and then subsequently removed and disposed of to allow a new sterile barrier 135 to be installed.

As with barrier devices 125 and 130 disclosed above, the shape of barrier 135 may provide overall dimensional stability. Barrier 140 may also be configured with foldable convolutions 175 similar to 125 and 130 to accommodate a wider range of lamp head size variations. These changes include the height of the retrofit adapter (007, 008 or 009) to the face of the light head window 002, the diameter of said window, and the shape/size of the light head assembly 001. Note that in Figures 8b and 9b, the barrier may extend beyond the edge of the lamp head to provide additional coverage for the sides of the lamp head assembly 001, the sides of the auxiliary handle 014, and the sides of other exposed surfaces. This extended coverage can be used to minimize or prevent contamination of these adjacent surfaces. This extended coverage applies to all disposable sterile barriers disclosed herein.

Multilayer Peelable Barrier

Figure 10 discloses a multi-layer laminate sterile barrier system 200 comprising multiple layers represented by components or peel-removable layers 205a, 205b, 205c and 205d. To use the system, the multi-layer sterile barrier system 200 may be applied or attached to the surgical light head 001 prior to performing a procedure adjacent to the light head. When a new sterile barrier is required, the top layer shown as 205a in FIG. or there are remaining barriers in the barrier system 200). After removal, the contaminated sterile barrier assembly 205 can be disposed of. This process can be repeated until all of the disposable sterile barrier layers (205a, 205b, 205c, and 205d) have been exhausted, whereupon a new multi-layer sterile barrier pack 200 can be applied to protect the lamp cap from biological contamination.

Install the supporting part

During installation of a sterile barrier (eg, 100 ), surgical light head 001 can be oriented in many different positions that facilitate efficient application of a thin, flexible plastic film to light head window 002 . Figure 12 discloses a support device 300 that simplifies installation by providing geometric stability to the sterile barrier as it is maneuvered into position on the surgical light head. Once the sterile barrier is in place, the support device 300 can be removed. The support means may comprise a low tack adhesive or other means to maintain the proper orientation between the support carrier and the sterile barrier during positioning.

The sterile barrier device can be similar to a shower cap used on the front of the surgical light head. The surgical light head can be shrink-wrapped around the surgical light head.

Any element described herein as singular may be plural (ie, any element described as "an" may be more than one). Any species element of a genus may have characteristics or elements of any other species element of the genus. The above configurations, elements or complete assemblies and methods for carrying out the present invention and elements thereof, and variations of aspects of the present invention may be combined and modified with each other in any combination. For example, the disclosed central variations, adhesive locations, and attachment methods are compatible with many of the sterile barrier configurations disclosed herein. Many other methods of sterile barrier attachment are considered to be potentially equally effective and may be superior to those disclosed herein. For example, where adhesives are disclosed, these adhesives may be replaced with many other attachment means such as magnets, Velcro, elastic bands, friction, static bonding, suction, mechanical fastening, or combinations thereof.

Claims (20)

1. A light transmissive disposable system comprising: a surgical light head comprising a light emitting window and at least one of: a positioning handle, a camera, a control joint; and A sterile barrier configured to cover the light emitting window; wherein the barrier has an aperture configured to accommodate at least one of: a positioning handle, a camera, a control junction. 2. The system of claim 1, wherein the barrier is at least partially translucent and/or transparent. 3. The system of claim 1, wherein the barrier is at least partially tapered in shape. 4. The system of claim 1, wherein the barrier comprises coaxial foldable convolutions. 5. The system of claim 1, wherein the barrier comprises a film and an adhesive. 6. The system of claim 1, wherein the barrier has a tab extending radially from the remainder of the barrier. 7. The system of claim 1, wherein the barrier is configured to cover the entire light emitting window. 8. The system of claim 1, wherein the barrier comprises a first peelable removable layer and a second peelable removable layer on the first peelable removable layer, wherein the The first peelable removable layer has a first pull tab, and wherein the second peelable removable layer has a second pull tab, and wherein the first pull tab is at least partially separated from the second pull tab Offset angularly. 9. A surgical lighting system comprising: An overhead surgical light head, which includes a light source, light-emitting window, and handle; and A sterile barrier configured to cover the light emitting window, wherein the barrier has an aperture, and wherein the handle extends distally through the aperture. 10. The system of claim 9, wherein the barrier is at least partially translucent and/or transparent. 11. The system of claim 9, wherein the barrier is at least partially tapered in shape. 12. The system of claim 9, wherein the barrier has a circular hole in the center. 13. The system of claim 12, wherein the circular hole has a feathered edge. 14. The system of claim 9, wherein the barrier comprises coaxial foldable convolutions. 15. The system of claim 9, wherein the barrier comprises a film and an adhesive. 16. The system of claim 9, wherein the barrier has a tab extending radially from the remainder of the barrier. 17. The system of claim 9, wherein the barrier is configured to cover the entire light emitting window. 18. The system of claim 9, wherein the barrier includes a first peelable removable layer and a second peelable removable layer on the first peelable removable layer. 19. The system of claim 18, wherein the first peelable removable layer has a first pull tab, wherein the second peelable removable layer has a second pull tab, wherein the first pull tab A tab is at least partially angularly offset from the second tab. 20. A method of maintaining a sterile surface comprising: applying a first disposable sterile barrier to an area of a light emitting device in which illumination is emitted, and wherein the barrier has holes, and wherein the device includes a handle, and wherein applying the first barrier comprises turning the handle toward the distally through the hole; removing the first disposable sterile barrier; and A second disposable sterile barrier is applied to the area of the light emitting device in which illumination is emitted.