This Application is a U.S. National Phase of the International Application No. PCT/GB2008/050509 filed Jun. 27, 2008 designating the U.S. and published on Jan. 8, 2009 as WO 2009/004369, which claims priority of Great Britain Patent Application No. 0712739.2 filed Jul. 2, 2007.
1. Field of the Invention
The present invention relates to apparatus and a method for the application of topical negative pressure (TNP) therapy to wounds. In particular, but not exclusively, the present invention relates to minimising noise generated by TNP therapy apparatus.
2. Background of the Invention
There is much prior art available relating to the provision of apparatus and methods of use thereof for the application of TNP therapy to wounds together with other therapeutic processes intended to enhance the effects of the TNP therapy. Examples of such prior art include those listed and briefly described below.
TNP therapy assists in the closure and healing of wounds by reducing tissue oedema; encouraging blood flow and granulation of tissue; removing excess exudates and may reduce bacterial load and thus, infection to the wound. Furthermore, TNP therapy permits less outside disturbance of the wound and promotes more rapid healing.
In our co-pending International patent application, WO 2004/037334, apparatus, a wound dressing and a method for aspirating, irrigating and cleansing wounds are described. In very general terms, this invention describes the treatment of a wound by the application of topical negative pressure (TNP) therapy for aspirating the wound together with the further provision of additional fluid for irrigating and/or cleansing the wound, which fluid, comprising both wound exudates and irrigation fluid, is then drawn off by the aspiration means and circulated through means for separating the beneficial materials therein from deleterious materials. The materials which are beneficial to wound healing are recirculated through the wound dressing and those materials deleterious to wound healing are discarded to a waste collection bag or vessel.
In our co-pending International patent application, WO 2005/04670, apparatus, a wound dressing and a method for cleansing a wound using aspiration, irrigation and cleansing wounds are described. Again, in very general terms, the invention described in this document utilises similar apparatus to that in WO 2004/037334 with regard to the aspiration, irrigation and cleansing of the wound, however, it further includes the important additional step of providing heating means to control the temperature of that beneficial material being returned to the wound site/dressing so that it is at an optimum temperature, for example, to have the most efficacious therapeutic effect on the wound. In our co-pending International patent application, WO 2005/105180, apparatus and a method for the aspiration, irrigation and/or cleansing of wounds are described. Again, in very general terms, this document describes similar apparatus to the two previously mentioned documents hereinabove but with the additional step of providing means for the supply and application of physiologically active agents to the wound site/dressing to promote wound healing.
The content of the above references is included herein by reference.
However, the above apparatus and methods are generally only applicable to a patient when hospitalised as the apparatus is complex, needing people having specialist knowledge in how to operate and maintain the apparatus, and also relatively heavy and bulky, not being adapted for easy mobility outside of a hospital environment by a patient, for example.
Some patients having relatively less severe wounds which do not require continuous hospitalisation, for example, but whom nevertheless would benefit from the prolonged application of TNP therapy, could be treated at home or at work subject to the availability of an easily portable and maintainable TNP therapy apparatus.
GB-A-2 307 180 describes a portable TNP therapy unit which may be carried by a patient clipped to belt or harness.
Such commercial apparatus are known to be noisy, partly in the interests of keeping weight to a minimum in portable apparatus. However, airborne noise generated from diaphragm pumps, which are often used, is known to be a significant source of irritation and discomfort to the user or patient and also to people in the vicinity. However, many different types of pump may be used including piston pumps, rotary vane pumps, turbo fan, for example, all generate noise. The level of discomfort produced by airborne noise in such apparatus is not to be underestimated as it has been known for patients to turn the apparatus off to alleviate the discomfort with the consequent obvious disadvantages to wound healing. Such commercial apparatus generally employ only a single element silencing comprising a simple cavity having a sound absorbent material therein.
It is an aim of the present invention to at least partly mitigate the above-mentioned problems.
It is an aim of embodiments of the present invention to provide portable apparatus for providing TNP therapy which is less noisy and produces less discomfort to a patient than known commercial apparatus.
According to a first aspect of the present invention there is provided portable apparatus for the provision of TNP therapy to a wound, the apparatus includes: a waste canister into which fluid is aspirated from a wound by aspiration pump means and a fluid flow path for at least a part of said aspirated fluid on an outlet side of said aspiration pump means wherein said fluid flow path on the outlet side comprises a silencing system having a plurality of silencing elements therein.
The invention is comprised in part of an overall apparatus for the provision of TNP therapy to a patient in almost any environment. The apparatus is lightweight, may be mains or battery powered by a rechargeable battery pack contained within a device (henceforth, the term “device” is used to connote a unit which may contain all of the control, power supply, power supply recharging, electronic indicator means and means for initiating and sustaining aspiration functions to a wound and any further necessary functions of a similar nature). When outside the home, for example, the apparatus may provide for an extended period of operation on battery power and in the home, for example, the device may be connected to the mains by a charger unit whilst still being used and operated by the patient.
The overall apparatus of which the present invention is a part comprises: a dressing covering the wound and sealing at least an open end of an aspiration conduit to a cavity formed over the wound by the dressing; an aspiration tube comprising at least one lumen therethrough leading from the wound dressing to a waste material canister for collecting and holding wound exudates/waste material prior to disposal; and, a power, control and aspiration initiating and sustaining device associated with the waste canister.
The dressing covering the wound may be any type of dressing normally employed with TNP therapy and, in very general terms, may comprise, for example, a semi-permeable, flexible, self-adhesive drape material, as is known in the dressings art, to cover the wound and seal with surrounding sound tissue to create a sealed cavity or void over the wound. There may aptly be a porous barrier and support member in the cavity between the wound bed and the covering material to enable an even vacuum distribution to be achieved over the area of the wound. The porous barrier and support member being, for example, a gauze, foam, inflatable bladder or known wound contact type material resistant to crushing under the levels of vacuum created and which permits transfer of wound exudates across the wound area to the aspiration conduit sealed to the flexible cover drape over the wound.
The aspiration conduit may be a plain flexible tube, for example, having a single lumen therethrough and made from a plastics material compatible with raw tissue, for example. However, the aspiration conduit may have a plurality of lumens therethrough to achieve specific objectives relating to the invention. A portion of the tube sited within the sealed cavity over the wound may have a structure to enable continued aspiration and evacuation of wound exudates without becoming constricted or blocked even at the higher levels of the negative pressure range envisaged.
It is envisaged that the negative pressure range for the apparatus embodying the present invention may be between about −50 mmHg and −200 mmHg (note that these pressures are relative to normal ambient atmospheric pressure thus, −200 mmHg would be about 560 mmHg in practical terms). Aptly, the pressure range may be between about −75 mmHg and −150 mmHg. Alternatively a pressure range of up to −75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also aptly a pressure range of below −75 mmHg could be used. Alternatively a pressure range of over −100 mmHg could be used or over −150 mmHg.
The aspiration conduit at its distal end remote from the dressing may be attached to the waste canister at an inlet port or connector. The device containing the means for initiating and sustaining aspiration of the wound/dressing may be situated between the dressing and waste canister, however, in a preferred embodiment of the apparatus embodying the present invention, the device may aspirate the wound/dressing via the canister thus, the waste canister may preferably be sited between the wound/dressing and device.
The aspiration conduit at the waste material canister end may preferably be bonded to the waste canister to prevent inadvertent detachment when being caught on an obstruction, for example.
The canister may be a plastics material moulding or a composite unit comprising a plurality of separate mouldings. The canister may aptly be translucent or transparent in order to visually determine the extent of filling with exudates. However, the canister and device may in some embodiments provide automatic warning of imminent canister full condition and may also provide means for cessation of aspiration when the canister reaches the full condition.
The canister may be provided with filters to prevent the exhaust of liquids and odours therefrom and also to prevent the expulsion of bacteria into the atmosphere. Such filters may comprise a plurality of filters in series. Examples of suitable filters may comprise hydrophobic filters of 0.2 μm pore size, for example, in respect of sealing the canister against bacteria expulsion and 1 μm pore size against liquid expulsion.
Aptly, the filters may be sited at an upper portion of the waste canister in normal use, that is when the apparatus is being used or carried by a patient the filters are in an upper position and separated from the exudate liquid in the waste canister by gravity. Furthermore, such an orientation keeps the waste canister outlet or exhaust exit port remote from the exudate surface.
Aptly the waste canister may be filled with an absorbent gel such as ISOLYSEL (trade mark), for example, as an added safeguard against leakage of the canister when full and being changed and disposed of. Added advantages of a gel matrix within the exudate storing volume of the waste canister are that it prevents excessive movement, such as slopping, of the liquid, minimises bacterial growth and minimises odours.
The waste canister may also be provided with suitable means to prevent leakage thereof both when detached from the device unit and also when the aspiration conduit is detached from the wound site/dressing.
The canister may have suitable means to prevent emptying by a user (without tools or damage to the canister) such that a full or otherwise end-of-life canister may only be disposed of with waste fluid still contained.
The device and waste canister may have mutually complementary means for connecting a device unit to a waste canister whereby the aspiration means in the device unit automatically connects to an evacuation port on the waste canister such that there is a continuous aspiration path from the wound site/dressing to an exhaust port on the device.
In the present invention the aspiration pump means may comprise a diaphragm-type pump which is efficient but tends to have a noisy exhaust caused by the fluid being pumped therethrough and the nature of the manner in which fluid is pumped.
As noted herein the waste canister is provided with suitable filters to prevent the expulsion from the canister of liquid exudate aspirated from the wound. In an embodiment of the present invention the waste canister is sited intermediate the aspirant conduit operably connected to the wound site and the aspirant pump means. Thus whilst the pump means is operating only gaseous fluid exits from the waste canister, liquids and bacteria being retained therein due to the filters as explained herein. Consequently, only gaseous fluids are expelled from the aspiration pump means outlet port and through the silencer system.
The silencing system may comprise a single exhaust conduit portion and a plenum chamber member positioned adjacent an exhaust outlet or further alternatively may itself comprise an exhaust outlet to atmosphere.
Alternatively, and in an embodiment of the present invention, the silencer system may have two primary exhaust conduit portions comprising a first exhaust conduit portion from a pump means outlet port; a plenum chamber member into which the first exhaust conduit portion feeds; and, a second exhaust conduit portion.
The exhaust conduit portion or portions may have predetermined dimensional parameters ducting exhaust fluid to an outlet adjacent a surface of a containing casing.
Such predetermined dimensional parameters of the exhaust conduit portion or portions may relate to length and cross-sectional area of the conduits and may be further related to wavelengths of sound waves passing through the exhaust fluid medium. The predetermined dimensions of the exhaust fluid conduit portions may also reduce the propagation of standing waves in the exhaust conduit portions. The predetermined dimensional parameters may be determined by routine experimentation and may depend inter alia on pump type and pump speed.
Owing to the compact nature of the device unit in which the exhaust system is accommodated, the exhaust conduit portion or portions are necessarily of a convoluted nature in order to connect the various components of the aspiration fluid flow path.
Whilst the exhaust conduit portion or portions may be of predetermined length, that length may be divided into smaller portions so as to accommodate other functions which depend upon a characteristic of the fluid flow therethrough. An example of this may be the provision of a flow meter, intermediate the aspiration pump outlet and the plenum chamber, for example. However, the flow meter may be accommodated in the second exhaust conduit portion if necessary.
The plenum chamber may have a relatively large volume and cross sectional area compared with the exhaust conduit portions. The plenum chamber may also be filled with sound-absorbent material which absorbs most of the sound energy as it is reflected back and forth between the walls of the plenum chamber. Advantageously the sound-absorbent material may also serve the dual purpose of being an odour filter. A suitable material may be CARBOTEC FB3-10.9 supplied by Vitek (trade marks).
In an embodiment of the present invention, the plenum chamber may have an open face which is sealed by an inner face portion of the outer casing structure of the device itself. Thus by disassembling the casing, the sound absorbing odour filtering material in the plenum chamber may be replaced when the device reaches a servicing point, if applicable. Such a structure also serves the additional important advantage of reducing the parts count needed to assemble the device and also lowering cost.
At the exhaust port adjacent the casing there may also be an open pore diffusing member such a foam pad, for example, through which the gaseous exhaust fluid is finally expelled to the atmosphere, the purpose of the diffusing member being to break up as many of the emerging sound waves as possible. However, such a diffuser member is not necessary and the final exhaust outlet may be a simple aperture in the casing.
Aptly, the exhaust port from the fluid path through the apparatus is provided with filter means to prevent offensive odours from being ejected into the atmosphere. As noted above this odour filter may be contained in the plenum chamber.
The silencing system according to the present invention may easily be able to achieve noise levels of less than 50 dBa.
In general terms the device unit comprises an aspirant pump; means for monitoring pressure applied by the aspirant pump; a flowmeter to monitor fluid flow through the aspirant pump; a control system which controls the aspirant pump in response to signals from sensors such as the pressure monitoring means and the flowmeter, for example, and which control system also controls a power management system with regard to an on-board battery pack and the charging thereof and lastly a user interface system whereby various functions of the device such as pressure level set point, for example, may be adjusted (including stopping and starting of the apparatus) by a user. The device unit may contain all of the above features within a single unified casing.
In view of the fact that the device unit contains the majority of the intrinsic equipment cost therein ideally it will also be able to survive impact, tolerate cleaning in order to be reusable by other patients.
In terms of pressure capability the aspiration means may be able to apply a maximum pressure drop of at least −200 mmHg to a wound site/dressing. The apparatus is capable of maintaining a predetermined negative pressure even under conditions where there is a small leak of air into the system and a high exudate flow.
The pressure control system may prevent the minimum pressure achieved from exceeding for example −200 mmHg so as not to cause undue patient discomfort. The pressure required may be set by the user at a number of discreet levels such as −50, −75, −100, −125, −150, −175 mmHg, for example, depending upon the needs of the wound in question and the advice of a clinician. Thus suitable pressure ranges in use may be from −25 to −80 mmHg, or −50 to −76 mmHg, or −50 to −75 mmHg as examples. The control system may also advantageously be able to maintain the set pressure within a tolerance band of +/−10 mmHg of the set point for 95% of the time the apparatus is operating given that leakage and exudation rates are within expected or normal levels.
Aptly, the control system may trigger alarm means such as a flashing light, buzzer or any other suitable means when various abnormal conditions apply such as, for example: pressure outside set value by a large amount due to a gross leak of air into system; duty on the aspiration pump too high due to a relatively smaller leakage of air into the system; pressure differential between wound site and pump is too high due, for example, to a blockage or waste canister full.
The apparatus of the present invention may be provided with a carry case and suitable support means such as a shoulder strap or harness, for example. The carry case may be adapted to conform to the shape of the apparatus comprised in the joined together device and waste canister. In particular, the carry case may be provided with a bottom opening flap to permit the waste canister to be changed without complete removal of the apparatus form the carry case.
The carry case may be provided with an aperture covered by a displaceable flap to enable user access to a keypad for varying the therapy applied by the apparatus.
In order that the present invention may be more fully understood, examples will now be described by way of illustration only with reference to the accompanying drawings, of which:
Referring now to
More particularly, as shown in
According to embodiments of the present invention, actual pressure at a wound site is not measured but the difference between a measured pressure (at the pump) and the wound pressure is minimised by the use of large filters and large bore tubes wherever practical. If the pressure control measures that the pressure at the pump head is greater than a target pressure (closer to atmospheric pressure) for a period of time, the device sends an alarm and displays a message alerting the user to a potential problem such as a leak.
In addition to pressure control a separate flow control system can be provided. A flow meter may be positioned after the pump and is used to detect when a canister is full or the tube has become blocked. If the flow falls below a certain threshold, the device sounds an alarm and displays a message alerting a user to the potential blockage or full canister.
Referring now to
Referring now to
A silencing system for an aspiration pump 248 of TNP therapy apparatus is denoted generally at 400 and comprises a first exhaust conduit portion 402; a plenum chamber 404; and, a second exhaust conduit portion 406 connected to an exhaust outlet 408. The two exhaust portion conduits 402, 406 are made from silicone rubber such as 60′ Shore hardness general purpose coloured silicone tubing and have a length of 156 mm, 128 mm and cross sectional area of 8 sq mm, respectively. These predetermined dimensional parameters are based upon experimentation on a diaphragm pump running at varying speeds (which is employed and controlled by the control system described hereinabove) dictated by the needs of the therapy required. Since the pump may run within a range of speeds, the dimensional parameters are determined by experimentation at average or worst conditions pertaining during operation of the apparatus.
In detail the exhaust silencing system according to a preferred embodiment of the present invention is shown in
The exhaust silencing system of a preferred embodiment as described hereinabove serves to reduce the noise generated by the pump 248 to very low and entirely acceptable levels so that a patient or wearer is not tempted to turn the apparatus off to gain temporary relief from noise irritation.
Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of the words, for example “comprising” and “comprises”, means “including but not limited to”, and is not intended to (and does not) exclude other moieties, additives, components, integers or steps.
Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.
Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith.
Number | Date | Country | Kind |
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0712739.2 | Jul 2007 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/GB2008/050509 | 6/27/2008 | WO | 00 | 12/30/2009 |
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