WOUND MANAGEMENT SYSTEMS AND METHODS FOR USING THE SAME
In one aspect, a wound management system is provided. The wound management system includes a multi-lumen cannula adapted to be disposed in a wound site. The multi-lumen cannula includes (1) a fiber optic light distribution system adapted to irradiate the wound site with light; (2) one or more catheters adapted to deliver a fluid to the wound site; and (3) one or more evacuation lines adapted to remove fluid from the wound site. Numerous other aspects are provided.
This application is a continuation of and claims priority to U.S. patent application Ser. No. 10/726,028, filed Dec. 2, 2003, which claims priority to U.S. Provisional Patent Application Ser. No. 60/430,243, filed Dec. 2, 2002. Each of these applications is hereby incorporated by reference herein in its entirety for all purposes.
FIELD OF THE INVENTIONThe present invention relates to medical treatments, and more specifically to wound management systems and methods for using such systems.
BACKGROUND OF THE INVENTIONThe clinical management of decubitus, ischial and sacral ulcers represents one of the most difficult challenges to medical professionals today. A stage-4 wound, for example, extends fully through soft tissue and often involves exposed bone and undermined surrounding tissue with significant sinus tracts that radiate out from the wound's epicenter. Such wounds usually have significant drainage, usually require daily dressing changes and are some of the most difficult and costly wounds to manage as patients are often bed ridden and very difficult to move.
The frequency of standard dressing changes for such wounds may range from a few times per day to several times per week, depending on wound drainage rate, healing rate, any infections, etc. In many cases, frequent (e.g., weekly) surgical debridement may be required to remove necrotic tissue and induce an inflammatory response necessary for new tissue granulation.
The frequency of dressing changes required during wound treatment has clear economic impacts. For example, under Medicare's new Prospective Payment System, visiting nurse services are paid a flat rate per month for patient home care regardless of the number of home visits required for dressing changes or other care. Accordingly, any new dressing system that can improve clinical efficacy and reduce the number of dressing changes required during wound treatment may not only improve patient care, but may potentially save millions of dollars annually.
To reduce the need for frequent dressing changes during treatment of draining wounds, drainage devices have been developed that utilize periodic suction and/or that generate a continuous negative pressure environment in a wound bed to express wound exudates (e.g., into a container), and thereby reduce dressing changes. While active exudate suctioning and a 100 to 150 mmHg negative pressure environment have been shown to improve wound closure as compared to atmospheric pressure wound management, such systems may infect a wound with airborne pathogens drawn into the wound via vacuum leaks in the wound dressing. Accordingly, an improved wound management system for treating wounds would be desirable.
SUMMARY OF THE INVENTIONIn a first aspect of the invention, a first wound management system is provided. The first wound management system includes a multi-lumen cannula adapted to be disposed in a wound site and having (1) a fiber optic light distribution system adapted to irradiate the wound site with light; (2) one or more catheters adapted to deliver a fluid to the wound site; and (3) one or more evacuation lines adapted to remove fluid from the wound site. The first wound management system further includes a light source coupled to the fiber optic light distribution system, and adapted to supply light to the fiber optic light distribution system. One or more fluid supplies are coupled to the one or more catheters, and are adapted to supply fluid to the one or more catheters. A vacuum system is coupled to the one or more evacuation lines, and is adapted to evacuate the one or more evacuation lines. The first wound management system also includes a controller coupled to the light source, the one or more fluid supplies and the vacuum system. The controller is adapted to (1) employ the vacuum system to remove exudates from the wound site; (2) employ the one or more catheters to deliver fluid to the wound site; and (3) employ the light source to deliver at least one light dose to the wound site.
In a second aspect of the invention, a second wound management system is provided. The second wound management system includes (1) one or more catheters adapted to deliver a fluid to a wound site; (2) one or more evacuation lines adapted to remove fluid from the wound site; (3) one or more fluid supplies coupled to the one or more catheters, and adapted to supply fluid to the one or more catheters; (4) a vacuum system coupled to the one or more evacuation lines, and adapted to evacuate the one or more evacuation lines; and (5) a controller coupled to the one or more fluid supplies and the vacuum system. The controller is adapted to employ the vacuum system to remove exudates from the wound site and employ the one or more catheters to deliver fluid to the wound site.
In a third aspect of the invention, a third wound management system is provided. The third wound management system includes a multi-lumen cannula adapted to be disposed in a wound site. The multi-lumen cannula includes (1) a fiber optic light distribution system adapted to irradiate the wound site with light; (2) one or more catheters adapted to deliver a fluid to the wound site; and (3) one or more evacuation lines adapted to remove fluid from the wound site. Numerous other aspects are provided, as are methods and apparatus in accordance with these and other aspects of the invention.
Other features and aspects of the present invention will become more fully apparent from the following detailed description, the appended claims and the accompanying drawings.
Large area chronic wounds such as decubitus, ischial and sacral ulcers generally require a dynamic environment in order to maintain an inflammatory process following surgical debridement. However, conventional dressings and treatment systems that employ active exudate suctioning and/or negative pressure environments tend to create static wound environments where marginal tissues fail, and colonized wounds tend to become infected if dressings are not changed frequently. In accordance with one or more embodiments of the present invention, methods, apparatus and systems are provided that can manage transient wound demands, such as through periodic suction of exudates, while supporting and maintaining other environmental parameters, such as controlled pressure, atmosphere, temperature, light dosing, etc., so as to maintain an inflammatory response that promotes tissue granulation with fewer dressing changes and lower cost.
With reference to
In the embodiment of the invention shown in
The supply/return catheter 106, the evacuation line 108 and/or the fiber housing line 112 each may comprise, for example, a section of suitable diameter flexible tubing (e.g., surgical silicone/rubber tubing, Teflon™, etc.). In one embodiment, the supply/return catheter 106 comprises approximately ¼ inch (outer diameter (O.D.)) flexible tubing, the fiber housing line 112 comprises approximately ⅜ inch O.D. flexible tubing and the evacuation line 108 comprises approximately ½ inch O.D. flexible tubing. Other tubing sizes may be employed for the supply/return catheter 106, the fiber housing line 112 and/or the evacuation line 108.
If the supply/return catheter 106 is employed primarily for supplying gas and/or liquid to a wound site, as shown in
The light source 116 may comprise any light source suitable of supplying a dosage of light having one or more wavelengths and/or center frequencies to the fiber optic light distribution system 104 (e.g., one or more lasers, light emitting diodes, filtered white light sources, etc.). In one particular embodiment, the light source 116 comprises a plurality of lasers and/or light emitting diodes capable of delivering light with wavelengths ranging from about 350 nanometers to about 880 nanometers to the fiber optic light distribution system 104. Other wavelength ranges may be employed. In at least one embodiment of the invention, the controller 122 may direct the light source 116 to deliver one or more (controlled) doses of one or more wavelengths of light to a wound site via the fiber optic light distribution system 104.
The gas supply 118 may comprise a source of one or more gases such as oxygen, nitric oxide, carbon dioxide, etc. In at least one embodiment of the invention, the controller 122 may direct the gas supply 118 to deliver one or more gasses, or a combination thereof, to the return/supply catheter 106 (e.g., at a desired pressure and/or flow rate, for a desired time period, etc.).
The controller 122 may comprise, for example, one or more appropriately programmed microprocessors, microcontrollers, or the like. Alternatively, the controller 122 may comprise a dedicated hardware circuit, or a combination of hardware and software.
As shown in
Each optical fiber 104a-h may comprise any conventional optical fiber (e.g., a single mode, multi-mode, glass, plastic, etc., fiber). In at least one embodiment of the invention, each optical fiber 104a-h comprises a multi-mode, plastic optical fiber. Such plastic optical fibers typically are less likely to break if bent when compared to glass fibers. (Such bending may occur when the fiber optic light distribution system 104 is bent within a wound area as described further below). Further, plastic optical fibers typically are less efficient at transmitting light energy. Accordingly, such optical fibers may absorb light energy and generate heat during light transmission (thereby heating any gas being transmitted near the fiber optic light distribution system 104, such as gas being supplied to a wound sight through the supply/return catheter 106 of
With reference to
-
- (1) maintain a micro-ventilation (e.g., 10-100 cc/hour) of pure gas or a mixture of gases (e.g., pure oxygen, nitric oxide, carbon dioxide, combinations thereof, etc.) in a wound site per a predetermined and/or predefined protocol to help induce tissue growth, such as through use of the gas supply 118, the supply/return catheter 106, the evacuation line 108 and/or the vacuum system 120;
- (2) temperature control gas supplied to a wound site to produce an ideal and/or controlled wound core temperature (e.g., about 100-101° F. in one embodiment); for example, wound bed temperature may be monitored (e.g., periodically or continuously) via the thermistor 110, and fed back to the controller 122; the controller 122 then may adjust gas supply temperature (e.g., via one or more heaters (not shown) coupled to the gas supply 118 and/or the supply/return catheter 106);
- (3) produce short transient changes in pressure to remove exudates (e.g., pressure changes ranging from about 150 mmHg negative pressure), and/or longer term micro-hyperbaric granulation phase wound pressures (e.g., up to about 800 mmHg); for example, the controller 122 may control gas flow rate to a wound site via the gas supply 118 and/or gas exhaust rate from the wound site via the vacuum system 120 to achieve such pressure changes and/or pressures; one or more pressure measurement devices, such as a +/−pressure manometer, may be employed to monitored pressure within a wound site;
- (4) provide dosed injection of liquids into a wound site (e.g., by permitting the injection of liquids such as saline, antibiotic solutions, coagulant solutions, etc., into the wound bed, allowing the solutions to diffuse within the wound bed, and then evacuating the solutions out of the wound bed); for example, the supply/return catheter 106, or another fluid delivery line, may be employed to deliver one or more liquids to a wound site (e.g., manually or via the controller 122), and the vacuum system 120/evacuation line 108 may be employed to remove the one or more injected liquids from the wound site (e.g., after a predetermined time period that may be set, for example, by the controller 122); and/or
- (5) employ the fiber optic light distribution system 104 to disperse light energy, preferably evenly, into the wound bed (e.g., at right angles to optical fibers 104a-h); preferably a broad range of wavelengths may be employed (e.g., ranging from at least UV-A (350 nm) to near infrared (880 nm)).
As described further below, a gas and/or liquid seal may be maintained around a wound site (e.g., employing a Tegaderm™ or similar material to form a gas/liquid seal) so as maintain a sterile barrier and retain wound atmosphere and exudates within the wound site. In at least one embodiment, all gas and liquids are introduced to, and removed from a wound sight via the wound management system 100.
With reference to
Operation of the inventive wound management system 100 of
With reference to
As stated, the cannula 102 is “connected” to the controller 122 via the light source 116, the gas supply 118, the vacuum system 120 and/or the thermistor 110 (which may, for example, be implemented in a single bed side unit (not shown), or as part of a larger system). In one or more embodiments of the invention, the gas supply 118 may comprise a heated oxygen supply, and the vacuum system 120 may include a container (not shown) for collecting exudates and other liquids from the wound 170. The light source 116 may comprise, for example, a 5.0 Watt 630 nm Helium-Neon LASER, and an LED near infrared and ultra-violet array. Other gas and/or light sources may be employed.
In at least one embodiment of the invention, the controller 122 may be pre-set (e.g., programmed) or manually set to provide a specific sequence of hyper-thermic and/or hyperbaric gas (e.g., oxygen, nitric oxide, carbon dioxide, combinations thereof, etc.) exposures to the wound 170 which may be followed, for example, by a period of vacuum and/or fluid exudate evacuation. The sequences of gas exposures, time for gas exposure and/or evacuation, and/or other process parameters may be adjustable or fixed.
In one or more embodiments, the controller 122 may be configured so as not to permit over or under pressure wound environments, or light over-dosing. A series of mechanical pressure relief's and/or vacuum breakers (not shown) may be employed to further protect the wound environment.
The controller 122 may activate the light source 116 and may sequence the light source 116 as desired (e.g., for an adjustable time period during, for example, hyperbaric oxygen phase of the therapy). For example, UV-A frequency light is bactericidal to organisms, but has positive photosensitive properties with regard to human tissue (e.g., in low dosages). Likewise, 630 to 880 nanometer light has been shown to stimulate cell mitochondria, growth factors and micro-vasodilatation.
The light source 116 (e.g., via the controller 122) also may be employed to sterilize the wound 170 with UV radiation and/or provide growth inducing near infrared light into undermined wound tissue areas 176 via the fiber optic light distribution system 104. In general, the cannula 102 may operate with virtually any light source. In a bed-side unit embodiment of the invention (e.g., wherein the light source 116, the gas supply 118, the vacuum system 120 and/or the controller 122 are contained within a bed-side unit (not shown)), the wound management system 100 typically will operate with a near infrared LASER or LED light source to promote healing. The system 100 also may accept (e.g., via a manual connection not shown) a controlled UV-B/C light source that may be employed to sterilize the wound 170 of pathogens. For example, a UV light source may be used in conjunction with antibiotics to eliminate pseutomosus bacteria or other pathogens.
In one or more embodiments of the invention, the gas supply 118 comprises a heated and variable medical oxygen supply that can deliver, for example, between about a 10 to 100 cc/minute oxygen flow at a maximum pressure of about 10 cm H2O into the wound site via the supply/return catheter 106. This may create a hyper-thermic (e.g., about 100-101° F.) and hyperbaric oxygen (e.g., about 5-10 cm H2O) environment within the wound 170. Excess oxygen and wound liquid exudates are pushed up the evacuation line 108. Other flow rates, gas types, wound temperatures and/or gas pressures may be employed.
The controller 122 may periodically (or at any other time) increase vacuum (e.g., to 50 mm Hg or some other suitable vacuum level) to evacuate any exudate from the wound cavity 182, and/or to purge the wound cavity 182. During this variable evacuation period, the flow of gas (e.g., oxygen) may be increased (e.g., to about 100 cc per minute in one embodiment).
As stated, the cannula 102 may contain one or more other fluid delivery lines, such as an intervenes (IV) solution port that permits the injection of any liquid medication or saline flush. The controller 122 may be adapted to initiate such medication/saline flushes. Additionally, such medication/saline flushes may be performed through the supply/return catheter 106 and/or through the fiber housing line 112.
Embodiments of the present invention thus provide a comprehensive wound management system with multi-parameter control (e.g., via a microprocessor or the like) of inner wound environment of pressure ulcers, surgically induced wounds, other chronic wounds, traumatic injuries, etc., that can provide a near ideal balance of temperature, pressure, atmosphere, vasoconstriction/dilation, clot factors and/or bacteriostatic/bactericidal conditions necessary for optimized tissue granulation. Controlled delivery of fluids to and vacuum removal of fluids from a wound site allows drainage of secretions and maintenance of a wound tissue hyper-thermal environment with delivery of medications to the wound environment (without compromising the sterile wound dressing barrier). That is, a multi-function gas, liquid and light wound management system is provided that may deliver ultraviolet and near-infrared light under controlled, hyper-thermic and/or hyper/hypobaric wound conditions in accordance with one or more predefined protocols.
The wound management system 900 includes a heater unit 908, such as a resistive heater or the like (e.g., an oxygen heater), adapted to heat gas supplied from the pressure regulation system 906 prior to delivery to a wound site; and a vacuum system 910 adapted to create a negative pressure (e.g., a 600-700 mm vacuum) within a collection container 912 that is coupled to the evacuation line 904. Other negative pressures may be created. In this manner, a negative pressure may be maintained in the evacuation line 904 relative to the wound site W (e.g., of a patient P) so that exudates and other fluids may flow from the wound site W and be collected within the container 912. A temperature gage 914 and/or a vacuum gage 916 may be employed to measure the temperature and/or pressure of fluid within the evacuation line 904. The wound management system 900 may or may not include a light distribution system, such as the fiber optic light distribution system 104 of
The foregoing description discloses only exemplary embodiments of the invention. Modifications of the above disclosed apparatus and methods which fall within the scope of the invention will be readily apparent to those of ordinary skill in the art. For instance, other pressures, temperatures, gases, light frequencies, flow rates, irrigation fluids than those described herein may be employed. Other catheter/line diameters may be employed. The supply/return catheter 106 and/or the fiber housing line 112 may have an outer diameter of between about 1/32 and ⅛ inch in one or more embodiments.
While the present invention has been described with reference to chronic wounds such as decubitus, ischial and sacral ulcers, it will be understood that the invention may be employed to treat virtually any wound. Other techniques for delivering light to a wound site may be employed in place of, or in addition to, the fiber optic light distribution system 104.
In one embodiment, the light source 116 may include ultraviolet (UV) and near infrared light sources. For example, the light source 116 may include UV-A, UV-B, UV-C bands and/or a 300-900 nm bandwidth infrared frequency transmission. Other types of light sources may be employed.
As used herein, a fluid may include a gas or a liquid.
Accordingly, while the present invention has been disclosed in connection with exemplary embodiments thereof, it should be understood that other embodiments may fall within the spirit and scope of the invention, as defined by the following claims.
Claims
1. A wound management system comprising:
- a multi-lumen cannula adapted to be disposed in a wound site and having: a fiber optic light distribution system adapted to irradiate the wound site with light; one or more catheters adapted to deliver a fluid to the wound site; and one or more evacuation lines adapted to remove fluid from the wound site;
- a light source coupled to the fiber optic light distribution system, and adapted to supply light to the fiber optic light distribution system;
- one or more fluid supplies coupled to the one or more catheters, and adapted to supply fluid to the one or more catheters;
- a vacuum system coupled to the one or more evacuation lines, and adapted to evacuate the one or more evacuation lines; and
- a controller coupled to the light source, the one or more fluid supplies and the vacuum system, and adapted to: employ the vacuum system to remove exudates from the wound site; employ the one or more catheters to deliver fluid to the wound site; and employ the light source to deliver at least one light dose to the wound site.
2. The wound management system of claim 1 wherein the multi-lumen cannula further comprises one or more temperature measurement devices coupled to the controller, the one or more temperature measurement devices adapted to measure a temperature of the wound site.
3. The wound management system of claim 1 wherein the fiber optic light distribution system comprises a plurality of optical fibers within a fiber housing line.
4. The wound management system of claim 3 wherein each optical fiber has an angled fiber/air interface.
5. The wound management system of claim 3 wherein at least one of the one or more catheters and the fiber housing line are positioned side-by-side within at least one of the one or more evacuation lines.
6. The wound management system of claim 3 wherein at least one of the one or more catheters and the fiber housing line are adapted to permit medication or saline flush of the wound site.
7. The wound management system of claim 1 wherein at least one of the one or more evacuation lines includes a plurality of intakes adapted to remove exudates from the wound site.
8. The wound management system of claim 1 wherein at least one of the one or more catheters includes a one-way valve adapted to:
- allow fluid flow from the one or more fluid supplies through the at least one catheter to the wound site; and
- prevent fluid flow from the wound site back to the one or more fluid supplies through the at least one catheter.
9. The wound management system of claim 1 wherein the controller is further adapted to direct the light source to deliver a plurality of doses of light to the wound site via the fiber optic light distribution system, each light dose having a wavelength ranging from about 350 to 900 nanometers.
10. The wound management system of claim 1 wherein the controller is further adapted to direct the one or more fluid supplies to deliver at least one of oxygen, nitric oxide and carbon dioxide to the one or more catheters.
11. The wound management system of claim 1 wherein the controller is further adapted to:
- regulate temperature of fluids supplied to the wound site;
- produce short transient changes in pressure to remove exudates from the wound site; and
- provide dosed injections of fluids into the wound site.
12. The wound management system of claim 1 wherein at least one of the one or more evacuation lines and at least one of the one or more catheters are concentric.
13. The wound management system of claim 1 wherein at least one of the one or more catheters and at least one of the one or more evacuation lines are coupled side-by-side.
14. The wound management system of claim 13 further comprising a fiber housing line coupled side-by-side to the at least one of the one or more catheters and the at least one of the one or more evacuation lines.
15. The wound management system of claim 1 wherein the one or more fluid supplies are adapted to deliver at least one of a medication or saline flush to the wound site.
16. The wound management system of claim 15 wherein the controller is further adapted to initialize the medication or saline flush.
17. The wound management system of claim 1 wherein the controller is further adapted to maintain a hyperbaric pressure at the wound site.
18. A wound management system comprising:
- one or more catheters adapted to deliver a fluid to a wound site;
- one or more evacuation lines adapted to remove fluid from the wound site;
- one or more fluid supplies coupled to the one or more catheters, and adapted to supply fluid to the one or more catheters;
- a vacuum system coupled to the one or more evacuation lines, and adapted to evacuate the one or more evacuation lines; and
- a controller coupled to the one or more fluid supplies and the vacuum system, and adapted to: employ the vacuum system to remove exudates from the wound site; and employ the one or more catheters to deliver fluid to the wound site.
19. The wound management system of claim 18 further comprising a pressure regulation system coupled to at least one of the one or more catheters, and adapted to provide at least one of a controlled pressure and flow rate of fluid to the wound site.
20. The wound management system of claim 18 further comprising:
- a light distribution system adapted to deliver one or more light doses to the wound site;
- wherein the controller is coupled to the light distribution system, and further adapted to control operation of the light distribution system.
21. A wound management system comprising:
- a multi-lumen cannula adapted to be disposed in a wound site and having: a fiber optic light distribution system adapted to irradiate the wound site with light; one or more catheters adapted to deliver a fluid to the wound site; and one or more evacuation lines adapted to remove fluid from the wound site.
22. The wound management system of claim 21 wherein the fiber optic light distribution system comprises a plurality of optical fibers within a fiber housing line.
23. The wound management system of claim 22 wherein each optical fiber has an angled fiber/air interface.
Type: Application
Filed: May 5, 2008
Publication Date: Nov 13, 2008
Inventor: Glenn Butler (Tarrytown, NY)
Application Number: 12/115,371
International Classification: A61N 5/06 (20060101);