WO2016061241A1

WO2016061241A1 - Medical device cover and method of use thereof

Info

Publication number: WO2016061241A1
Application number: PCT/US2015/055550
Authority: WO
Inventors: Murlikrishna KANNAN; Sushmitha SANTHOSH
Original assignee: Aditi Holdings Llc
Priority date: 2014-10-14
Filing date: 2015-10-14
Publication date: 2016-04-21

Abstract

The present invention is a medical device and monitor cover and method intended to address the dual problems of cleanliness of medical devices during patient procedures and is intended for single patient use. The cover contains a monitor cut out to allow clear view in of the monitor. The device covers medical devices quickly prior to the procedure and prevents contamination. The cover is easily removable for disposal post procedure.

Description

MEDICAL DEVICE COVER AND METHOD OF USE THEREOF PRIORITY CLAIM

[001] This application claims priority to United States provisional application number 62/063,708 filed on October 14, 2014, the contents of which is expressly incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[002] Not Applicable

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISK APPENDIX

[003] Not Applicable

BACKGROUND OF THE INVENTION

[004] The medical care environment is one in which care providers commonly use the same medical devices with multiple patients. Common devices include diagnostic devices for anesthesia, EKG, EEG, ultrasound.

[005] The diagnostic devices are complex electronic instruments operated with a plurality of switches, buttons and knobs. While manufacturers frequently address cleanliness and/or sterility of probes and electrodes that come in contact with the patient, no provision is made to prevent contamination of the core device.

THE PROBLEM

[006] Much of modern medicine is conducted with complex devices having touch screens and advanced electronics.

[007] Regardless of the make and type of medical device, the technician will touch the equipment after touching the patient and will place or rest related equipment on the device. Regardless of the precautions taken, the surfaces of the device will become contaminated. Common interventions performed by technicians involve insertion of electrodes and probes into and on a patient. Whilst performing these interventions, the technician is constantly touching the device to make adjustments . As a result the technician providers will contaminate the machine with blood, body fluids and microorganisms.

[008] Current practice follows guidelines that recommend that medical equipment surfaces be cleaned by disinfecting wipes after patient care. This involves complete top down cleaning of the machine each time and every time between procedures. This involves time consuming meticulous cleaning which increases exam room turn over times, as well as the use of harmful chemicals and disinfectants on electronic equipment not to mention the need for expensive human labor.

[009] Multidrug resistant bacteria like Methicillin resistant staphylococci, Clostridium difficile, Vancomycin resistant enterococci are all a major threat to patient safety. Patients infected with these deadly microbes are labeled "contact isolation patients". These patients need surgery from time to time and they are brought into the operating room. Different institutions have different policies to deal with contact isolation patients in the operating room. The one common objective is to reduce the transfer and spread of these dangerous microbes to other patients. This involves extensive cleaning of the operating room and the equipment in the operating room. Inadequate cleaning of medical devices increases risk of cross contamination. It is undisputed that medical devices harbor bacteria and are a source of contamination in the patient care setting.

[ 00 1 0 ] Yet another problem that is infrequently addressed is the setting up of equipment for the next patient right next to the contaminated equipment. A clean setup cannot be accomplished in a contaminated environment. There are different reasons for this practice but the most common has been to reduce exam room turnover times between cases. Contaminated equipment sometimes is not removed and is discovered during subsequent patient care.

SUMMARY OF THE INVENTION

[0011] The medical device cover is intended to address the dual problems of cleanliness of equipment during care of the patient. The cover is a single patient use, easily applied cover that can be applied in couple of minutes prior to the procedure and removed within seconds at the end of care. [0012] The cover is intended as a barrier to protect the machine. Barrier concept uses the simple idea of prevention is better than cure. Barrier concept has been used for ages in condoms. Efficient barriers have revolutionized surgical gowns and drapes. A good surgical barrier is a minimum requirement for surgery as this prevents infection more than anything else.

[0013] The cover is a simple non- sterile barrier that will run along the entire working surface of the machine. The cover will allow the continued operation of the medical device machine but does not require direct contact to the machine. The barrier will be made according to industry guidelines to be electrostatic, fire retardant and tear resistant. This barrier will prevent biohazard material like blood and patient body fluids from contaminating the medical device machine during patient care.

[0014] It is an object of the invention to provide customizable barrier protection for medical devices.

[0015] It is an object of the invention to protect medical devices from contamination.

[0016] It is an object of the invention to reduce medical device turnover time in between surgical cases.

[0017] It is an object of the invention to provide a means of covering each component of a medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a front view of a machine cover.

[0019] Figure 2 is a front view of an alternative embodiment of a machine cover.

[0020] Figure 3 is a front view of an alternative embodiment of a machine cover.

[0021] Figure 4 is a side view of a machine cover. Both sides are identical.

[0022] Figure 5 is a back view of a machine cover.

[0023] Figure 6 is a drawing showing the cover of the present invention installed on a medical device.

[0024] Figure 7 is a front view of an alternative embodiment of a medical device.

[0025] Figure 8 is a back view of the cover shown in Figure 7

[0026] Figure 9 is a perspective view of a machine cover of the present invention.

[0027] Figure 10 is a drawing showing the front of a machine cover of the present invention.

[0028] Figure 11 is a drawing showing the back of a machine cover of the present invention.

[0029] Figure 12 is a drawing showing the left side of a machine cover of the present invention. [0030] Figure 13 is a drawing showing the right side of a machine cover of the present invention.

[0031] Figure 14 is a drawing showing the top of a machine cover of the present invention.

[0032] Figure 15 is a drawing showing the bottom of a machine cover of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0033] Referring to Figure 6, the medical device comprises a vertical surface 4 having a plurality of indicators and control knobs 2 which are used to control the functions of the medical device. The indicators and knobs must be accessible and visible during any procedure. A monitor 12 is located on the top of the machine.

[0034] The device may be placed on a cart for mobility. The cart 6 may include a horizontal work surface 3 and may optionally include drawers, castors or wheels 9 and rails 8 for mounting additional equipment.

[0035] The medical device 5 may include at least one video monitor 12 for displaying patient information and/or running software.

[0036] Many medical devices are by necessity set up next to an operating table. As is readily apparent, when present in a patient care environment the medical device is subject to contamination by blood and other body fluids. The medical device, because of its proximity to the operating table, will by necessity be contaminated by the need to touch it during the procedure.

[0037] While procedures exist for cleaning and disinfecting medical devices and the cart or cabinet upon which it rests, the procedures rarely remove 100% of the biological contamination. This is due to both the complexity of the surfaces to be cleaned and the fact that there is often pressure to prepare an operating room for the next patient. As such, medical devices are presently a likely means for transferring pathogens between patients. Hospital acquired infections are a major problem today and a failsafe means is needed to prevent and stop this contamination.

[0038] Referring to Figures 1-5, and 7-15 the present invention comprises a cover 10 which protects the medical device 5 and optionally the cart 6 from contamination. The cover 10 is made from any material which is suitable for use in the operating room such as plastics or fabrics which are either cheap enough to be disposable after use or can be sterilized using existing equipment. Most preferred are disposable plastics such as polyethylene, although other plastic sheeting may be used. [0039] The cover 10 comprises a portion 13 which is intended to cover a horizontal surface 14 for of the medical device 5 and optionally a cart 6 and a portion monitor surface cover 15 for covering the monitor 12 Optionally, the cover 10, further comprises a second vertical surface cover for covering the front 7 of the cart 6. The cover 10 may optionally include additional coverage for the sides and back of the medical device and sides and back of the cart. Optionally, one or more pockets may be included in the cover 10. The pockets may be removable at perforations.

[0040] In one embodiment, the cover 10 is formed of a single sheet of material with means for attaching it to the medical device. The means for attaching can be elastic 53 along the edges, form fitting shapes, Velcro, adhesive, tape, snaps, buttons, ties or any means suitable for attachment. Ties 57 are shown for illustration in Figure 2.

[0041] In one embodiment the cover is a bag which fits over top of the medical device without any means for securing. The front and back sides of the cover can be equal length or the front can be longer to provide better coverage of the front of the medical device. Optionally, the edges of the cover may include an elastic edge 53 which is used to retain the cover 10 in place on the machine.

[0042] The monitor surface cover contains a cut out 51 which allows the monitor 12 to be covered but allows the monitor to be readily viewable. In the simplest form, the cut out 51 is simply a cut out sized to the intended monitor screen. Referring to Figure 2, the cut out 51 can be optionally framed with an adhesive or tape 55 for securing the cover to the face of the monitor 12.

[0043] In another embodiment, an optically clear monitor screen overlay 54 is included. This overlay can be any suitable material which does not obstruct the view of the monitor. In one embodiment a self-adhesive polymer such as is used to protect cell phone and computer tablet screens is used. The means of attachment is not important as long as the monitor is clearly viewable. Static cling and clear adhesives can be used on the overlay itself or the overlay can be fastened with adhesives around the perimeter.

[0044] Referring to Figure 3, the cover material around the computer screen can also be made of an absorbent material 56 which serves to absorb fluids which may get splashed on the screen. Such absorbent material can be backed with a moisture barrier and/or adhesive 55 as shown in Figure 2.

[0045] The cover 10 should either be of a sufficient optical clarity to allow observation of the monitors and or meters on the medical device 5 or have clear portions for viewing the instrumentation. The material of the cover 10 should not be so thick that a gloved technician cannot operate switches or knobs 2. When polyethylene sheeting is used the material is preferably from 1-5 mils thick with 2-3 mils most preferred. One of skill in the art will be able to choose suitable materials based on their resistance to tearing or perforation and the tactile feel of knobs and switches when contacted through the material.

[0046] The cover 10 may be draped over the medical device 5 in pillow case fashion or attached to the medical device 5 and cart 6 using various means such as ties, Velcro, adhesive, tape, rubber bands, straps, thread, zippers, hooks, buttons, rivets or other mechanical fasteners.

[0047] In some embodiments the cover is packaged with covers for other equipment such as additional monitors and keyboards, computer mice, laryngoscopes, etc. Such covers are suitably form fitting for the device they are covering. In one embodiment such covers are a form fitting bag which can be snugged around the device. In others, they are sized sheets of plastic which may be draped or folded around the device and secured. In one embodiment, the cover for a computer monitor is a plastic sheet with elastic around the perimeter allowing the device to be secured to the monitor with the elastic.

[0048] The cover 10 may be manufactured such that it is made from a stretchable material to better form fit. Elastic may be used as needed to allow material to stretch for placement and contract to hold the covers in place.

[0049] In another embodiment shown in Figure 7, the sides 65 of the cover 10 may be fully or partially boxed to be more form fitting to the medical device.

[0050] In one embodiment, the cover 10, consists of a front cover 1 which is sized large enough to wrap around the top 21 and sides 20 of the medical device 5, a rear cover 3 which is sized to drape down the sides 20 of the cart 6, and a second vertical surface cover 19 which covers the front 7 of the cart 6.

[0051] In another embodiment, the cover 10 is wrapped around the medical device medical device 5 and cart 6 like a skirt.

[0052] Referring to Figures 6-15, the cover 10, can be constructed like a pillow case or envelope to slip over the top of a monitor and drape over the medical device 5. The front of the cover 52, contains a cutout 51 for a monitor. The back of the cover 60 is attached to the front of the cover 52 around the perimeter via lamination, welding, glues, adhesives, Velcro, ties, snaps and other means known in the art and forms an envelope or pillow case with an opening 61 on the back side of the front cover 52, the opening formed by the front cover 52 and the rear cover 60. The opening 61 is sized to fit over a monitor and may extend the full width of the cover or just a part of the cover. Optionally, the open 61 can be created by perforations which can be torn to create the desired width. The back of the cover 60 can be any length desired, but is preferably matched to the height of the monitor such that the cover can be inserted over the monitor like a pillow case with the front of the cover not having a back, draped across the top and front of the medical device.

[0053] The back of the cover 60 can be made from the same material as the front, or may be a different material. Because there generally are no switches, knobs or indicators on the back of equipment, the back of the cover 60 does not have to be transparent and may be opaque and have color.

[0054] Optionally, the cover may be coated with, or impregnated with a disinfectant, antiseptic, antibiotic or an antimicrobial composition during manufacturing or during installation. Such compositions could include triclosan, or anything suitable for use in the operating room environment.

[0055] It will be readily apparent from one of skill in the art that the present cover 10 can be comprised of a single part or multiple pieces which can attach to each other, or not.

[0056] The present invention further comprises a method of covering a medical device to protect it from contamination and for protecting patients from contamination emanating from the medical device. The method comprises:

a. Placing an open cover 10 on a medical device 5.

b. Attaching the top of the cover to a monitor on top of the medical device 5. c. Attaching the cover to the horizontal surface of the medical device 5 d. Optionally applying an antimicrobial composition to the cover and /or any exposed parts of the medical device or cart.

e. Using the medical device 6 through the cover 10 during the procedure.

f. Optionally placing any contaminated equipment into the optional pouches on the front of the cover.

g. Optionally, separating the pouches to allow transport of the contaminated equipment.

h. Remove and discard the cover from the medical device and cart.

[0057] In a preferred embodiment the cover is folded in such a way that it can be installed as follows:

a. The package is opened and the cover initially unfolded on the horizontal surface of the medical device. b. A portion of the cover for covering the medical is folded upwards over the monitor and secured in place.

c. Any optional portion of the cover for covering the cart is unfolded downwards and secured in place.

It will be readily apparent to one of skill in the art that substantial deviation from the disclosure herein is possible without departing from the spirit of the invention.

Claims

1. A medical device cover comprising:

A front cover and a back cover joined on a top and two sides of each cover the bottom side being open for fitting over a medical device, wherein the front surface of the cover has at least one area for viewing a monitor;

a means for securing the cover to the medical device and/or cart;

wherein the front cover allows visibility through the cover to view gauges and or indicators; and

wherein the cover does not substantially interfere with the ability to actuate buttons, knobs, and or switches on the medical device.

2. The medical device cover of claim 1, wherein the means for securing is selected from elastic along the edges, form fitting shapes, Velcro, adhesive, tape, snaps, buttons or ties.

3. The medical device cover of claim 2 wherein an adhesive is used to secure the cover to the monitor.

4. The cover of claim 1 wherein the vertical surface cover further comprises an absorbent material.

5. The cover of claim 1 wherein the front and back covers are separated by a side cover.

6. The cover of claim 1 wherein the area for viewing a monitor in the front cover is a cut out sized to the monitor.

7. The cover of claim 1 wherein the area for viewing a monitor in the front cover is an optically clear polymer.

8. The cover of claim 7 wherein the optically clear polymer is affixed to the monitor.

9. The cover of claim 1 further comprising extensions for covering the side or front of the medical device.

10. The cover of claim 1 wherein the cover has pockets.

11. The cover of claim 1 wherein the cover has perforations for removing pockets or for reaching through the cover.

12. A method of reducing contamination of a medical device comprising: covering a medical device with a cover which comprises a covering portion for at least one horizontal and one vertical surface of the machine while allowing visibility through the cover to gages and indicators as well the ability to actuate buttons, knobs, and/or switches required during a procedure; wherein the vertical surface cover has a cutout for allowing clear view of a monitor; and securing the hygienic cover to the machine.

13. The method of claim 12 further comprising attaching the vertical cover to a

monitor which an adhesive or a tape.

14. A medical device cover comprising:

a vertical surface cover having a front portion and a back portion wherein the front an back portion are attached on 3 sides to form an envelope sized to fit over a monitor, wherein the front portion has a cutout for the monitor;

a horizontal surface cover which is an extension of the front portion of the vertical surface cover;

wherein the front cover allows visibility through the cover to gauges and or indicators; and

wherein the cover does not substantially interfere with the users ability to actuate buttons, knobs, and or switches as required during a procedure.