WO2014165854A1

WO2014165854A1 - Device and method to control catheter-related infections

Info

Publication number: WO2014165854A1
Application number: PCT/US2014/033207
Authority: WO
Inventors: Ori BELSON; Tahel ALTMAN
Original assignee: Belson Ori
Priority date: 2013-04-06
Filing date: 2014-04-07
Publication date: 2014-10-09

Abstract

A disinfection device and method for controlling infections related to indwelling catheters, such as urinary catheters or peritoneal dialysis catheters, uses one or more wavelengths of light having antimicrobial activity. A first component delivers trans-catheter illumination with a first portion of antimicrobial light directed radially inward toward an indwelling catheter that is positioned within a lumen of the device. At least some of the first portion of antimicrobial light passes through the wall of the catheter to disinfect an internal surface of the catheter and any fluid within the lumen of the catheter. A second component delivers a second portion of antimicrobial light in a longitudinal direction exterior to the indwelling catheter to disinfect a surface of the patient's tissue surrounding the insertion site of the catheter. At least some of the antimicrobial light from the first and/or second component also serves to disinfect an external surface of the catheter.

Description

DEVICE AND METHOD TO CONTROL CATHETER-RELATED INFECTIONS

FIELD OF THE INVENTION

The present invention relates generally to indwelling catheters, such as urinary catheters or peritoneal dialysis catheters. More particularly, it relates to a disinfection device and method to control infections related to indwelling catheters.

BACKGROUND

Catheter-related infections are common, costly and responsible for substantial morbidity and mortality, and impose a heavy burden on healthcare systems worldwide (Haley et al. 1985; Raad et al. 1992; Mermel 2000; Darouiche 2004; Hall and Farr 2004; Raad and Hanna 2005; Stone et al. 2005). It is generally accepted that biofilms form shortly after catheter placement and that biofilm formation is the basis for catheter-related infection.

Although infection rates are reduced if catheter use is minimized (Cornia et al, 2003 ; Reilly et al, 2006 ; Topal et al, 2005) and closed drainage systems are used (Allepuz-Palau et al, 2004 ; Thornton and Andriole, 1970), other preventive measures, such as antiseptic or antibiotic-coated catheters, remain controversial (Jahn et al, 2007 ; Schumm and Lam, 2008).

There are considered to be three main routes by which micro-organisms get into the urinary tract: (A) The catheter pushes bacteria colonizing the distal urethra into the bladder while being inserted. (B) Bacteria colonizing the distal urethra migrate up the outside of the catheter after it has been inserted. (C) Bacteria contaminating the drainage bag or catheter/bag junction migrate up the inside of the catheter or are introduced by retrograde flow of urine into the bladder. (JMT Barford et al, 2009). These mechanisms of catheter-associated urinary tract infections are illustrated in FIG. 1.

A well-known method for killing bacteria is exposure to ultraviolet light (UV). The most germicidal part of the UV spectrum, designated ultraviolet-C (UVC), occurs at wavelengths 280- 100 nm (Jimmy Bak et al, 2009). UVC doses between 10 and 300 J m-2 effectively kill 99.9% of viable planktonic bacteria (Qui et al. 2004).

The idea of using UVC light for catheter disinfection is not new and has been proposed and described by others. For instance, it has been suggested to dispose optical fibers lengthwise in catheters and thereby illuminate and disinfect the inner surface of the catheter with UVC light by moving the fiber up and down inside the catheter (Boudreaux 2002). Another proposed solution is based on the idea of reducing the catheter wall thickness in zones where the biofilm

contamination is expected to form. The UVC light is then partly transmitted from an external light source into the interior of the catheter and used to disinfect local parts (Eckhardt 2002). Yet all of the described methods could eliminate only one of the proposed mechanisms by which catheter-related infections occur, and none address the mechanism by which bacteria colonizing the distal urethra migrate up the outside of the catheter after it has been inserted.

Thus, there is a need for a device and method for addressing all the mechanisms by which catheter related urinary tract infections occur.

SUMMARY OF THE INVENTION

The current application describes a disinfection device that combines a component for trans- catheter wall UV light treatment to eradicate the bacteria within the catheter lumen and a component for external UV light treatment to the catheter external surface and a surface of the patient's tissue surrounding the insertion site of the catheter, for example the skin near the opening of the urethra where a urinary catheter enters the body or the abdominal wall skin where a peritoneal catheter enters the body.

A first, trans-catheter component could be made, for example, from a UV light source with or without a filter and with or without lenses. The light source could also generate a wider variety of wavelengths that includes, among other wavelengths, the UV range. This component will preferable clip or connect to the external wall of the catheter when the light will be directed to the wall and the internal lumen. In one example the catheter could have a clear window made in such a way that will enable the UV light to penetrate the lumen and work on the urine inside. The device could be battery operated or connected to an electrical outlet.

The disinfection device uses a wavelength of light or a combination of wavelengths having antimicrobial activity, preferably ultraviolet light, more preferably ultraviolet C (UVC) light. The disinfection device could use any other wavelength of light including white light or any other wavelength that will work as bactericidal or antimicrobial.

The light could be shined continuously or intermittently according to how the device will be programmed to work.

The device could also be connected to an external light source (that could be hung on the bed, for example) and the light will be delivered from this light source to the device via optical fibers, reflective waveguides, hollow waveguides or other known light conducting technologies.

A second component will shine a light longitudinally toward the patient's tissue surrounding the insertion site of the catheter. For example, the light will be shined circumferentially all around the opening of the urethra to ensure that there is no part of the catheter or the skin that the catheter is in contact within that has not been treated.

For the female urethra area, the design may be different than for male patients as the area to be illuminated has a different shape. For the purpose of area illumination, one or more light sources could work.

The same device or a different device using the same idea of illuminating the fluid in the catheter and the skin around the entry point to the body as well and the external surface of the catheter near the entry point could be used for any other catheters like: peritoneal dialysis catheter, hemodialysis catheter, venous catheter, central line catheter, brain pressure measurement catheter, surgical drainage catheter, pneumothorax drainage catheter, and any other catheter entering the body.

In order to weaken the contact of the bacteria with the catheter, the device may include a vibrating element that will vibrate the catheter wall where it is attached to release the bacteria and enable better light exposure. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the mechanisms of catheter-associated urinary tract infections as described by JMT Barford et al, 2009.

FIG. 2 is a schematic representation of a disinfection device utilizing antimicrobial light according to the present invention.

FIG. 3 illustrates an embodiment of a disinfection device according to the invention.

FIG. 4 illustrates the disinfection device of FIG. 3 in an open position.

FIG. 5 illustrates another embodiment of a disinfection device according to the invention.

FIG. 6 illustrates an embodiment of a disinfection device that utilizes an external light source.

FIG. 7 illustrates an embodiment of a disinfection device that utilizes a reflective surface to distribute antimicrobial light.

FIG. 8 illustrates a urinary drainage catheter adapted for use with the disinfection device.

FIG. 9 illustrates a urinary drainage catheter and disinfection device used for a male patient.

FIG. 10 illustrates a urinary drainage catheter and disinfection device used for a female patient.

FIG. 11 illustrates a disinfection device according to the invention used with another indwelling catheter.

DESCRIPTION OF THE INVENTION

FIG. 1 illustrates the mechanisms of catheter-associated urinary tract infections. There are considered to be three main routes by which micro-organisms get into the urinary tract: (A) The catheter pushes bacteria colonizing the distal urethra into the bladder while being inserted. (B) Bacteria colonizing the distal urethra migrate up the outside of the catheter after it has been inserted. (C) Bacteria contaminating the drainage bag or catheter/bag junction migrate up the inside of the catheter or are introduced by retrograde flow of urine into the bladder. (JMT Barford et al, 2009).

FIG. 2 is a schematic representation of a disinfection device 100 according to the present invention. The device 100 has a first component 102 that delivers trans-catheter illumination with a first portion of light having antimicrobial activity directed radially inward toward an indwelling catheter 200 that is positioned within a lumen 104 of the device 100. At least some of the first portion of light passes through the wall 204 of the catheter 200 to disinfect an internal surface 206 of the catheter 200 and any fluid that is passing through the lumen 208 of the catheter 200. In addition, the device 100 has a second component 106 that delivers a second portion of light having antimicrobial activity in a longitudinal or axial direction exterior to the indwelling catheter 200 to disinfect a surface of the patient's tissue surrounding the insertion site of the catheter 200. At least some of the antimicrobial light from the first component 102 and/or the second component 106 also serves to disinfect an external surface 202 of the catheter 200. Preferably, the antimicrobial light will disinfect the external surface 202 of the catheter 200 immediately adjacent to the insertion site.

The disinfection device 100 thus addresses all three of the mechanisms of catheter-associated infections as described above in connection with FIG. 1. The first portion of antimicrobial light delivered by the first component 102 of the device 100 addresses mechanism (C) by disinfecting the interior of the catheter, while the second portion of antimicrobial light delivered by the second component 106 of the device 100 addresses mechanism (A) by disinfecting a surface of the patient's tissue surrounding the catheter entry site, and at least some of the first portion and/or second portion of antimicrobial light addresses mechanism (B) by disinfecting the exterior surface of the catheter.

The disinfection device 100 uses a wavelength of light or a combination of wavelengths having antimicrobial activity, preferably ultraviolet light (400-100 nm), and more preferably ultraviolet- C (UVC) light (280-100 nm). Within the range of UVC light, there are a number of sources available with different wavelength characteristics:

Mercury vapor lamps with a quartz envelope emit at a peak wavelength of 253.7 nm, which has been shown to have very good antimicrobial activity. Excimer lamps that emit in the UVC range are available, for example Krl* (190 nm), ArF* (193 nm), KrBr* (207 nm), KrCl* (222 nm), KrF* (248 nm), Xel* (253 nm) and Cl₂*(259 nm). UVC with a wavelength of 207 nm has been shown to have very good antimicrobial activity coupled with very low cytotoxicity and mutagenicity to human cells. (Buonanno M, Randers-Pehrson G, Bigelow AW, Trivedi S, Lowy FD, et al. (2013) 207-nm UV Light - A Promising Tool for Safe Low-Cost Reduction of Surgical Site Infections. I: In Vitro Studies. PLoS ONE 8(10): e76968. doi: 10.1371/journal.pone.0076968)

UVC light emitting diodes (LEDs) are available in a range of wavelengths, most notably from 250 nm to 280 nm.

Laser diodes that emit in the ultraviolet and UVC range are available, including wavelengths of 262, 266, 349, 351, 355, and 375 nm.

Diode pumped UVC lasers are available, including wavelengths of 205 nm and 230 nm. (Sharp Laboratories of Europe, Ltd.)

Alternatively, the disinfection device may utilize UVA (400-315 nm) or UVB (315-280 nm) light, which also have antimicrobial activity. The disinfection device could use a combination of UVA, UVB and/or UVC light. In addition, certain wavelengths and combinations of

wavelengths of infrared and near-infrared light have been found to have antimicrobial activity. For example, a combination of 870 nm and 930 nm from near-infrared laser diodes has been found to inactivate many infectious microbes including Methicillin-resistant Staphylococcus aureus (MRSA). (J Am Podiatr Med Assoc 99(4): 348-352, 2009) Infrared or near-infrared light may be used alone or in combination with UVA, UVB and/or UVC light.

FIGS. 3 and 4 illustrate an embodiment of a disinfection device 100 according to the invention. FIG. 3 shows the device 100 in a closed position, while FIG. 4 shows the device 100 in an open position to allow a catheter to be inserted into the lumen 104 of the device 100. In this example, the disinfection device 100 has a body 110 with an approximately cylindrical proximal portion 112 and a conical distal portion 114 that extends from the proximal portion 112. The first component 102 of the device 100 is housed in the cylindrical proximal portion 112 and the second component 106 is housed in the conical distal portion 114 of the device 100. The first component 102 in this case is constituted by a first array of light emitting diodes (LEDs) 120 that are directed radially inward the lumen 104 of the device 100. The second component 106 is constituted by a second array of light emitting diodes (LEDs) 122 that are directed longitudinally or axially in a distal direction with respect to the device 100.

The body 110 of the device 100 is made with a longitudinal opening or slit 116 that allows the device 100 to be opened up as shown in FIG. 4 to allow a catheter to be inserted into the lumen 104 of the device 100. Optionally, there may be a hinge or living hinge 118 in the body 110 of the device 100 opposite to the slit 116. Preferably, the body 110 of the device 100 is cast or molded from a flexible, low durometer polymer material that will be atraumatic if it comes into contact with the patient's tissues. The elasticity of the polymer material will hold the body 110 of the device 100 in the closed position around a catheter. Alternatively, a latch, spring or other closure mechanism may be provided to hold the body 110 of the device 100 in the closed position.

In an alternative configuration, the body 110 of the device 100 may be made in two halves that separate to allow a catheter to be inserted into the lumen 104 of the device 100.

In the example shown, the conical distal portion 114 of the device 100 has a concave distal surface that is intended to conform to the anatomy of a male patient. Alternatively, the distal portion 114 of the device 100 may be configured as a perpendicular flange or as a cone with a convex distal surface to be suitable for the anatomy of male and female patients.

FIG. 5 illustrates another embodiment of a disinfection device 100 according to the invention. In this example, the disinfection device 100 has an approximately cylindrical body 110 housing the first component 102 for delivering a first portion of light having antimicrobial activity as in the example above. However, the second component 106 for delivering a second portion of light having antimicrobial activity is constituted by at least one light source 130, such as an LED, mounted on a flexible or articulated arm 132. In the example shown, there are two light sources 130 mounted on two flexible arms 132. Other numbers of light sources 130 are also possible. The flexible or articulated arms 132 allow the light sources 130 to be selectively adjusted to direct the antimicrobial light where it is desired. Antimicrobial light from the light sources 130 may be directed to disinfect the patient's tissue surrounding the catheter entry site and/or the external surface of the catheter adjacent to the entry site. The body 110 of the device may be configured with a slit or may be made in two separable parts for inserting a catheter into the lumen 104 of the device 100 as described above.

FIG. 6 illustrates an embodiment of a disinfection device 100 that utilizes an external light source 140. The external light source 140 may contain one or more mercury vapor lamps, excimer lamps, light emitting diodes, laser diodes, diode pumped lasers or other sources of light having antimicrobial activity. A single wavelength or a combination of wavelengths may be used. The light source 140 may include or be operably connected to a timer or a programmable controller 148 to provide a desired regimen of antimicrobial light therapy. In addition, the external light source 140 may contain a fan, a heat sink or other thermal control mechanism. The external light source 140 may be made in a variety of physical configurations. For example, the external light source 140 may be configured to hang on a hospital bed, to sit on a bedside table or to hang from an IV pole.

Antimicrobial light is conducted from the external light source 140 to the body 110 of the device 100 via optical fibers, reflective waveguides, hollow waveguides or other known light conducting technologies 142. Preferably, the light conductors 142 will be arranged with one or more light conductors 144 configured to emit a first portion of light radially inward into the body 110 of the device 100 and with one or more additional light conductors 146 configured to emit a second portion of light axially from a distal end of the device 100.

FIG. 7 illustrates an embodiment of a disinfection device 100 that utilizes a reflective surface 150 to distribute antimicrobial light from the device 100. Light having antimicrobial activity is produced by one or more light sources 152 that are arranged on a first side of the body 110 of the device 100. The light sources 152 may be one or more LEDs or one of the other light sources described herein, including an external light source 140 as described above. Light emitted from the light sources 152 reflects off of a reflective surface 150 that is positioned opposite to the light sources 152 so that antimicrobial light will be distributed all around the periphery of a catheter. Additional light sources 154 may be used to provide a second, axially-directed portion of light. Alternatively, the body 110 of the device 100 may be configured to direct a portion of the emitted and reflected light from a distal surface of the device 100. Although the body 110 of the device 100 is shown as cylindrical, other geometries could also be used. For example, the body surfaces 150 to distribute antimicrobial light from the light sources 152.

FIG. 8 illustrates a urinary drainage catheter 200 that is specially adapted for use with the disinfection device 100 of the present invention. The catheter 200 has an elongated tubular body 212 with an internal drainage lumen 208. Optionally, the catheter 200 may have an inflatable balloon 220 or other anchor mechanism. The wall 204 of the urinary catheter 200 is opaque throughout most of its length with a clear window 210 that will enable the light to illuminate the internal surface 206 of the catheter 200 and the fluid that is in the catheter lumen 208. The window 210 need not be visually clear as long as it is sufficiently transparent to the

wavelength(s) of antimicrobial light used by the device 100. The device 100 will be positioned outside the catheter 200 over this window 210. The device 100 could also be clipped over a regular catheter and the light will be illuminated through the opaque wall. Preferably, the wall of the catheter will be sufficiently transparent to the wavelength(s) of antimicrobial light used by the device 100 to provide antimicrobial activity on the inner surface of the catheter. For example, Dai et al have shown that commercially available catheters made of silicone or polyurethane are sufficiently transparent to UVC light to provide antimicrobial activity on the inner surfaces of the catheters. (Photochem Photobiol. 2011 ; 87(1): 250-255.

doi: 10.1111/j. l751-1097.2010.00819.x.)

FIG. 9 illustrates a urinary drainage catheter 200 and disinfection device 100 used for a male patient M. The urinary catheter 200 is inserted into the urethra via the meatus which is located at the top of the glans penis. The device 100 will be clipped around the catheter 200 close to the entry point to the urethra. The device 100 as described above will deliver a first portion of light having antimicrobial activity, for example UVC light, through the catheter wall so that the light will be able to treat the fluid within the catheter lumen. The distal side of the device 100 will deliver a second portion of light having antimicrobial activity over the skin near the meatus, and the catheter 200 where it enters the body. In order to improve the bactericidal effect of the light, the device 100 could optionally include a vibrating element 230 that will vibrate the wall of the catheter 200 and the fluid inside to make sure that all the fluid layers will have good exposure to the antimicrobial light.

FIG. 10 illustrates a urinary drainage catheter 200 and disinfection device 100 used for a female patient F. The first component 102 that illuminates the catheter lumen can be the same as described above, but since the skin around the catheter 200 where it enters the urethra is flat, the second component 106 that illuminates the entry site can be designed differently. The second component 106 at the distal end of the device 100 will deliver a second portion of light that is projected on the area of the body around the catheter entry point.

FIG. 11 illustrates a disinfection device 100 according to the invention used with another indwelling catheter 200, for example a peritoneal dialysis catheter, hemodialysis catheter, venous catheter, central line catheter, brain pressure measurement catheter, surgical drainage catheter, pneumothorax drainage catheter, and any other catheter entering the body. The first component 102 delivers a first portion of light inwardly toward the catheter 200 and the second component delivers a second portion of light that is projected on the area of the body around the catheter entry point P.

Each embodiment of the disinfection device 100 may utilize a timer or a programmable controller to provide a desired regimen of antimicrobial light therapy. The antimicrobial light therapy may be continuous or intermittent. The first component 102 and the second component 106 of the device 100 may be operated simultaneously or separately in different antimicrobial light therapy regimens. Optionally, the disinfection device 100 may be used to deliver antimicrobial light therapy to the catheter and/or to the insertion site prior to insertion of the catheter.

Each embodiment of the disinfection device 100 may be powered by disposable batteries, rechargeable batteries and/or it may plug into an electrical outlet.

Claims

1. A method for disinfecting an indwelling catheter and a patient's tissue surrounding an entry point of the indwelling catheter, the method comprising: directing a first portion of light having antimicrobial properties radially inward toward the indwelling catheter such that at least some of the first portion of light is transmitted through a wall of the catheter for disinfecting an interior surface of the catheter; and directing a second portion of light having antimicrobial properties longitudinally toward the patient's tissue surrounding the entry point of the catheter for disinfecting a surface of the patient's tissue .

2. The method of claim 1, wherein at least some of the first portion of light having antimicrobial properties also disinfects an exterior surface of the catheter.

3. The method of claim 1, wherein at least some of the second portion of light having antimicrobial properties also disinfects an exterior surface of the catheter.

4. The method of claim 1, wherein the first portion and the second portion of light having antimicrobial properties comprise ultraviolet light.

5. The method of claim 1, wherein the first portion and the second portion of light having antimicrobial properties comprise ultraviolet-C light.

6. The method of claim 5, wherein the ultraviolet-C light has a peak wavelength of

approximately 254 nanometers.

7. The method of claim 5, wherein the ultra violet-C light has a peak wavelength of approximately 207 nanometers.

8. The method of claim 1, wherein the first portion of light having antimicrobial properties is delivered by a cylindrical portion of a device surrounding the indwelling catheter and the second portion of light having antimicrobial properties is delivered from a distal end portion of the device.

9. The method of claim 8, wherein the distal end portion of the device has a conical portion extending from the cylindrical portion of the device.

10. The method of claim 8, further comprising opening the cylindrical portion of the device and placing the cylindrical portion of the device around the indwelling catheter.

11. The method of claim 8, wherein the indwelling catheter comprises a window that is substantially transparent to the first portion of light having antimicrobial properties such that an inner surface of the indwelling catheter is exposed to the light having antimicrobial properties.

12. A device for disinfecting an indwelling catheter and a patient's tissue surrounding an entry point of the indwelling catheter, the device comprising: first means for directing a first portion of light having antimicrobial properties radially inward toward the indwelling catheter; and second means for directing a second portion of light having antimicrobial properties

longitudinally toward the patient's tissue surrounding the entry point of the catheter.

13. The device of claim 12, wherein the device comprises a hollow cylindrical proximal portion and a conical distal end portion extending from the cylindrical proximal portion of the device, and wherein the first portion of light having antimicrobial properties is directed radially inward within the hollow cylindrical proximal portion and the second portion of light having

antimicrobial properties is directed longitudinally from the conical distal end portion.

14. The device of claim 13, wherein the device has an open loading position for placing the device around the indwelling catheter and a closed operating position.

15. The device of claim 12, wherein the device comprises a hollow cylindrical body having a distal end portion, and wherein the first portion of light having antimicrobial properties is directed radially inward within the hollow cylindrical body and the second portion of light having antimicrobial properties is directed longitudinally from the distal end portion.

16. The device of claim 15, wherein the device has an open loading position for placing the device around the indwelling catheter and a closed operating position.

17. The device of claim 12, further comprising a light source for producing light having antimicrobial properties.

18. The device of claim 17, wherein the light source comprises a light emitting diode, an excimer lamp, or a diode laser.

19. The device of claim 17, wherein the light source is configured to produce ultraviolet light having antimicrobial properties.

20. The device of claim 17, wherein the light source is configured to produce ultraviolet-C light having antimicrobial properties.

21. The device of claim 20, wherein the ultraviolet-C light has a peak wavelength of

approximately 254 nanometers.

22. The device of claim 20, wherein the ultraviolet-C light has a peak wavelength of

approximately 207 nanometers.

23. The device of claim 17, wherein the light source is configured to produce near infrared light having antimicrobial properties.

24. The device of claim 17, further comprising a timer or programmable controller to provide a desired regimen of antimicrobial light therapy.

25. The device of claim 17, wherein the light source is battery powered.

26. The device of claim 12, wherein the device comprises a hollow cylindrical body having a first light source positioned for directing the first portion of light having antimicrobial properties radially inward within the hollow cylindrical body; and a second light source mounted on a flexible arm extending from the hollow cylindrical body for directing the second portion of light having antimicrobial properties toward the patient's tissue surrounding the entry point of the catheter.