WO2009093116A1 - Procédé et système pour panser une plaie - Google Patents
Procédé et système pour panser une plaie Download PDFInfo
- Publication number
- WO2009093116A1 WO2009093116A1 PCT/IB2009/000080 IB2009000080W WO2009093116A1 WO 2009093116 A1 WO2009093116 A1 WO 2009093116A1 IB 2009000080 W IB2009000080 W IB 2009000080W WO 2009093116 A1 WO2009093116 A1 WO 2009093116A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- wound
- pressure
- dressing
- tissues
- perfusion
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/74—Suction control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/96—Suction control thereof
Definitions
- This invention relates to a wound dressing system, and more particularly, to a wound dressing system of the type in which a negative pressure relative to atmospheric pressure is applied to a wound, typically by way of a dressing including a pressure dispersing medium such as a foam or other spongy or porous material, with a view to enhancing the healing process.
- the invention also relates to a method of enhancing the treatment of a wound as well as a method of enhancing the formation of granulation tissue in appropriate circumstances.
- negative pressure as used in this specification is intended to mean reduced atmospheric pressure that is negative relative to atmospheric pressure in the sense in which that term is commonly used in the art.
- wound dressing relates to a collapsible device, such as a NPWT dressing, as opposed to a rigid device, such as a suction cup.
- NGWT negative pressure wound therapy
- Morykwas et al in numerous porcine studies, demonstrated that a suction pressure of -125 mmHg, not only created the highest increase in blood flow (four fold), but also the largest amount of granulation tissue, both of which are desirable in wound healing. For this reason, applicant understands that a suction pressure of -125 mm Hg is now recommended worldwide. Morykwas et al found that suction pressures higher or lower than -125 mmHg both resulted in lesser beneficial effects in granulation tissue or blood flow than did -125 mmHg. In fact, at suction pressures of -400 mmHg, Morykwas found that blood flow was less than baseline levels, conflicting with the theory that the hypobaric pressure of a NPWT dressing facilitates blood flow toward it.
- NPWT dressings can be of a rigid or collapsible variety, implying that the conditions created by these two variations are equivalent. These varieties are perceived by those skilled in the art to create the same physical conditions and result in the same effects on the tissues i.e. a reduction in tissue pressure with a concomitant increase in blood flow. Based on research conducted, it is the applicant's belief that a rigid device and a collapsible device behave in a manner so different to one another, that the conditions created are entirely the opposite.
- a rigid suction device creates hypobaric tissue pressures, which has been demonstrated to increase perfusion, and is the subject of many published patents and research in the prior art.
- a collapsible device such as a NWPT dressing, however, creates hyperbaric tissue pressures. These have been demonstrated by the applicant to result in reduced perfusion, contrary to what has been the common perception to date.
- a finding more pertinent to the scope of this invention is that the increase in tissue pressure as a result of the application of suction with a NWPT dressing is different in different tissues, despite use of the same suction pressure in each of these wounds.
- Many variables influence the amount of increased tissue pressure generated, including the consistency of the underlying tissues, the amount of and type of foam/interface dressing used, the configuration of the dressing (circumferential or non-circumferential) and the amount of suction applied.
- the amount of perfusion reduction observed for the same suction pressure was also different in different individuals. This observation led to the realisation that a specific suction pressure, e.g. -125 mmHg, is unlikely to be ideal for all wounds, as this leads to entirely different levels of tissue pressure and blood flow.
- a wound treatment system including a wound dressing suitable for the application of a negative pressure to a wound in relation to which it is applied in use, means for applying a negative pressure to the wound dressing, and means for adjusting the extent of the negative pressure, the wound treatment system being characterised in that sensor means is provided having an output proportional to a variable selected from one or more of a force measured at the wound-dressing interface, a positive pressure within the tissues immediately adjacent the relevant wound, and perfusion (measured either directly or indirectly) of the tissues, and wherein control means are provided for enabling manual or automatic adjustment of the negative pressure within the dressing system to be made in response to one or more outputs received from said sensor means with an aim of adjusting the value of the variable towards a desired value thereof.
- the sensor means to be selected from a pressure transducer operatively positioned within the tissue immediately adjacent a wound under treatment, a force sensor placed on top of the wound and under the wound dressing, and a perfusion sensor associated with the tissue immediately adjacent a wound under treatment; and for the control means to be computer or microprocessor operated to automatically control the suction in response to outputs from the sensor means with the suction being regulated until the target value of the variable is achieved.
- a method of enhancing the treatment of a wound utilising a negative pressure applied to a wound by way of a suitable wound dressing the method being characterised in that sensor means is positioned relative to the wound so as to respond to a variable selected from one or more of a force measured at the wound-dressing interface, a pressure within the tissues immediately adjacent the relevant wound, and perfusion (measured either directly or indirectly) of the tissues and to provide an output in response to the value of the variable, communicating the output to control means, and manually or automatically adjusting the negative pressure with an aim of adjusting the value of the variable towards a desired value thereof.
- a method of enhancing the formation of granulation tissue within a wound in the human body such enhancement being carried out utilising a negative atmospheric pressure applied to the wound by way of a suitable wound dressing, the method being characterised in that sensor means is positioned relative to the wound so as to respond to a variable selected from one or more of a force measured at the site-dressing interface, a pressure within the tissues immediately adjacent the relevant site, and perfusion (measured either directly or indirectly) of the tissues and to provide an output in response to the value of the variable, communicating the output to control means, and manually or automatically adjusting the negative pressure with an aim of adjusting the value of the variable towards a desired value thereof.
- the invention is based on applicant's understanding that different types of tissues will develop different tissue pressures for the same suction pressure, and as a result thereof different changes in perfusion, and that this means that there cannot be a fixed, ideal suction pressure applicable in all instances. Rather, it is more likely that there is an ideal tissue pressure to which at least particular types of wounds, or wounds in particular patients, will respond most favourably. Such specific tissue pressure is not known at this stage but with further research, this may be discovered in the future. This increased tissue pressure has been demonstrated to reduce perfusion in the tissues adjacent the wound on initial application of NPWT. As NPWT is known to be beneficial to wound healing, it can be extrapolated that a certain level of reduced perfusion in the tissues adjacent to the wound may be desirable.
- tissue death will occur if perfusion is reduced to such an extent that there is a severe lack of oxygenation and nutrient delivery to the cells. Therefore the desired reduction in perfusion, which may be beneficial, will conceivably have a limit, beyond which detrimental effects may be observed. It is another object of this invention, therefore to monitor perfusion within the tissues adjacent the wound and regulate the amount of suction in the NPWT system to achieve only the limited reduction in perfusion, which may be beneficial to wound healing. This aspect of the invention will not only ensure a controlled reduction in perfusion to ensure optimal wound healing but will serve as a safety feature to prevent tissue death.
- tissue which have borderline perfusion/blood flow pressures, due to trauma for example, might be compromised if negative pressure wound therapy with unregulated suction pressure is applied.
- the negative pressure wound therapy and resultant increase in tissue pressure has the potential to completely occlude the blood vessels/vasculature (depending on the amount of suction applied), causing tissue death.
- Having a sensing means to monitor perfusion in the tissues adjacent to the wound will immediately detect dangerously low levels of perfusion and, using a feedback loop, regulate the subatmospheric pressure to more appropriate levels for these compromised tissues, thereby avoiding tissue death.
- Figure 1 is a schematic section taken through a wound to which a negative pressure wound therapy dressing has been applied and illustrating in block format the other components of the system of the invention.
- Figure 2 is a graph illustrating tissue pressure increments in response to circumferential NPWT.
- FIG. 1 illustrates one example of a system according to the invention.
- a negative pressure wound therapy dressing (1 ) is illustrated as being applied to an open skin wound (2).
- the wound therapy dressing comprises a body (3) of porous material, in this instance a foam, and an adhesive occlusive film dressing (4) that covers the body (3) of porous material and seals in an airtight manner to the surrounding skin (5).
- Suction tubing (6) communicates with the body of porous material and connects it to a suction generating device (7). This arrangement is substantially conventional and well known in the art.
- the suction tubing may enter the airtight environment from beneath the adhesive film where it is attached to the skin or, as in the instance of this example, the suction tubing may be attached to the film dressing via an adhesive flange (8), which ensures an airtight seal between the two.
- a hole made in the film prior to application of this suction tubing and flange, allows for transmission of the negative pressure to the body of porous material.
- a sensor is associated with the wound in a position that will depend on the nature of the sensor and the nature of the wound and the positioning and nature of which is further described below.
- the sensor is adapted to provide an output that is communicated to a control unit in the form of a processor (10) in this instance via a communications cable (11 ). Communication may, of course, be by way of suitable wireless technology.
- This feedback is, in use, processed by the processor and utilised to adjust the amount of suction generated by the suction generating device automatically to control the suction in response to outputs from the sensor means with the suction being regulated until the target value of the variable is achieved.
- the feedback measurements can be displayed on a screen (12), which may be embodied in a single unit as part of the suction device and processing unit. In certain instances, if an automated feedback loop is not utilised, the feedback loop may be carried out manually by a skilled operator, who can then manually adjust the suction pressure according to readings on the display screen.
- this sensor may measure the force the foam applies to the tissues, pressure within the tissues, tissue perfusion or a combination of any two or all three of these variables.
- this sensor should measure force if it is placed on the wound surface (in between the porous material and the wound), or pressure if placed within the wound soft tissues.
- pressure measurement in the space between the porous material and the wound is perceived as being difficult to carry out accurately, as this may indicate the air/fluid pressure (which is likely to be hypobaric and is not indicative of the underlying tissue pressure, which is likely to be hyperbaric).
- a force sensor placed on top of the wound surface however, is unlikely to be significantly influenced by the ambient air/fluid pressure and will register an increased mechanical force when suction is applied to the body of porous material, as the porous material pushes down on the sensor.
- the sensor may also incorporate the ability to assess perfusion, either directly, for example by way of photometry of red blood cells, or indirectly, for example by assessing tissue oxygen saturation. This perfusion-sensing sensor may be placed onto or into the tissues.
- the amount of suction generated by the suction device (7) will vary according to the readings of the sensor (9). Should the sensor measure forces/pressures higher than the desired predetermined setting, then the suction pressure will be reduced by the feedback mechanism and vice versa for forces/pressures that are measured to be lower than the desired predetermined settings. This adjustment will continue until the desired settings are achieved.
- the suction device will, in a similar manner (using the feedback mechanism), be regulated to decrease suction if perfusion drops below the predetermined level and increase suction if the opposite is required. Alarms and/or suction trip switches for safety purposes, may be incorporated into the software and hardware of the system.
- the regulating software may be configured to respond to these sensors' inputs in a variety of ways.
- the software may be configured to regulate the amount of suction based on an average of the various sensors' measurements.
- Another potential configuration would have the software respond to the sensor which measures the highest or lowest measurement of multiple sensors used. This latter configuration may be particularly useful when one dressing is likely to generate different forces/pressures in different areas beneath the same dressing. This may occur for example, if placed over various tissue types or tissues with different consistencies or different contours. The pressure increase in each type may be different for the same amount of suction pressure and therefore may be advisable to have a sensor over or in each different tissue area.
- the software could be configured to allow the sensor experiencing the greatest force or pressure or drop in perfusion to dictate the feedback to the suction generating device.
- the system should allow for a physician to manually override any specific sensor's feedback. This may be necessary where the physician is aware that a particular sensor is likely to experience extremes of measurement but which may not necessarily be to the detriment of the patient. If part of the dressing is placed directly over exposed bone, for example, it may experience greater forces in this area when suction is applied than in areas of softer tissue consistencies. However, it may be that bone is fairly resilient to these forces as they are unlikely to affect the perfusion within the bone, particularly if the bone is denuded of periosteum (the only component of bone to potentially suffer ill effects if exposed to large forces/pressures). More Specific Example
- the negative pressure wound therapy dressing may be the type manufactured by Kinetic Concepts, lnc (KCI ® ), USA.
- KCI ® dressing is comprised of a reticulated, open cell, polyurethane foam.
- the communicating nature of the pores (400 - 600 ⁇ m diameter) of the foam allows for even distribution of the suction pressure throughout the foam.
- the foam is placed onto a wound and is then covered by an adhesive plastic film.
- the film which seals off the wound and foam, allows the wound and foam environment to become airtight.
- a hole is then made in the film.
- Suction tubing, with an adhesive sealing flange at one end, is then attached around the hole to create an airtight connection.
- suction pressure is applied via the suction tubing, the dressing collapses and creates a vacuum like seal.
- the manufacturer recommends dressing changes every 48 hours; however this may vary depending on clinical needs.
- the sensor/s are placed onto or within the wound tissues (depending on the type of sensor used) prior to application of the foam.
- the foam could conceivably be pre-manufactured to contain the required sensors in its wound-facing base.
- the wires of the sensors could exit the airtight environment in a manner similar to that used for the suction tubing, or could simply exit beneath the adhesive film stuck to the skin (although this may increase the risk of losing an airtight seal). Wires could, alternatively, even traverse tissues to exit at a site remote from the wound site, as indicated by numeral (13) in Figure 1.
- Healthy tissues may respond better to a different amount of force than poorly perfused tissues could tolerate, for example. Even once these values are ascertained, it can be seen that due to the fact that many of these variables may influence wound healing individually, it would be ideal to have a sensing system as provided by this invention which has the ability to monitor force, tissue pressure and perfusion simultaneously and respond to these individual sensor outputs intelligently, based on adequate clinical research data. Similar research will need to be conducted to ascertain forces, tissue pressures and levels of perfusion at which tissue damage is likely to occur. Tissue damage is influenced by a variety of variables in this scenario, such as amount of pressure applied and length of time, amount of hypoperfusion as a result of this pressure, type of tissue (nerve, muscle, fat etc.).
- the addition of the system of this invention to a conventional negative pressure wound therapy dressing could significantly enhance wound healing and prevent complications, such as tissue necrosis.
- Using the feedback system of the invention it should be possible to attain a specific force on the tissues or pressure within the tissues or level of perfusion within the tissues. This system will facilitate achieving the optimum tissue pressure or force or perfusion, which maximally enhances wound healing and in addition, prevents the negative pressure wound therapy system from causing tissue necrosis due to overt tissue pressure and/or hypoperfusion.
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- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
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- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- External Artificial Organs (AREA)
Abstract
L'invention concerne un système de traitement de plaie qui comprend un pansement pour plaie (1) permettant l'application d'une pression négative sur une plaie sur laquelle il est appliqué lors de son utilisation, des moyens (6, 7) d'application d'une pression négative au pansement pour plaie, et un moyen (10) d'ajustement de la force de la pression négative. Il comprend également un dispositif de capteur (9) dont la sortie est proportionnelle à une variable choisie parmi une ou plusieurs parmi une force mesurée à l'interface plaie-pansement, une pression positive dans les tissus immédiatement adjacents à ladite plaie et une perfusion (mesurée directement ou indirectement) des tissus. Il comprend un moyen de commande (12) qui permet l'ajustement manuel ou automatique de la pression négative dans le système de pansement en réponse à une ou plusieurs données reçues depuis ledit moyen de capteur dans le dessein d'ajuster la valeur de la variable à une valeur désirée.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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ZA200800755 | 2008-01-25 | ||
ZA2008/00755 | 2008-01-25 |
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WO2009093116A1 true WO2009093116A1 (fr) | 2009-07-30 |
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PCT/IB2009/000080 WO2009093116A1 (fr) | 2008-01-25 | 2009-01-19 | Procédé et système pour panser une plaie |
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Cited By (27)
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WO2011023384A1 (fr) * | 2009-08-29 | 2011-03-03 | Vcs Medical Technology Gmbh | Dispositif de vacuothérapie comportant un capteur de pression |
WO2012057882A1 (fr) | 2010-10-27 | 2012-05-03 | Kci Licensing, Inc. | Pansements à pression réduite sans fils, interactifs, procédés et systèmes associés |
EP2464412A2 (fr) * | 2009-08-13 | 2012-06-20 | Michael Simms Shuler | Méthodes et systèmes de pansement favorisant la cicatrisation des tissus lésés |
CN102970949A (zh) * | 2010-07-19 | 2013-03-13 | 凯希特许有限公司 | 用于电力探测敷件中渗出物存在的***和方法 |
US8974428B2 (en) | 2011-11-01 | 2015-03-10 | J&M Shuler Medical, Inc. | Mechanical wound therapy for sub-atmospheric wound care system |
CN104490573A (zh) * | 2014-11-03 | 2015-04-08 | 北京大学口腔医学院 | 用于颅颌面软组织缺损疾病的负压治疗装置 |
US9526920B2 (en) | 2010-10-12 | 2016-12-27 | Smith & Nephew, Inc. | Medical device |
US9737649B2 (en) | 2013-03-14 | 2017-08-22 | Smith & Nephew, Inc. | Systems and methods for applying reduced pressure therapy |
US10058643B2 (en) | 2006-10-20 | 2018-08-28 | J&M Shuler Medical, Inc. | Sub-atmospheric wound-care system |
US10155070B2 (en) | 2013-08-13 | 2018-12-18 | Smith & Nephew, Inc. | Systems and methods for applying reduced pressure therapy |
CN109316279A (zh) * | 2012-07-16 | 2019-02-12 | 马萨诸塞州大学 | 负压伤口闭合设备 |
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US10556045B2 (en) | 2014-12-30 | 2020-02-11 | Smith & Nephew, Inc. | Synchronous pressure sampling and supply of negative pressure in negative pressure wound therapy |
US10583228B2 (en) | 2015-07-28 | 2020-03-10 | J&M Shuler Medical, Inc. | Sub-atmospheric wound therapy systems and methods |
US10744239B2 (en) | 2014-07-31 | 2020-08-18 | Smith & Nephew, Inc. | Leak detection in negative pressure wound therapy system |
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US11166726B2 (en) | 2011-02-04 | 2021-11-09 | University Of Massachusetts | Negative pressure wound closure device |
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US11471586B2 (en) | 2015-12-15 | 2022-10-18 | University Of Massachusetts | Negative pressure wound closure devices and methods |
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US10149930B2 (en) | 2009-08-13 | 2018-12-11 | J&M Shuler, Inc. | Methods and dressing systems for promoting healing of injured tissue |
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US10117979B2 (en) | 2010-07-19 | 2018-11-06 | Kci Licensing, Inc. | Systems and methods for electrically detecting the presence of exudate in dressings |
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JP2014500739A (ja) * | 2010-10-27 | 2014-01-16 | ケーシーアイ ライセンシング インコーポレイテッド | 対話型無線減圧ドレッシング、方法、およびシステム |
CN103179929A (zh) * | 2010-10-27 | 2013-06-26 | 凯希特许有限公司 | 交互式无线减压敷件、方法以及*** |
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US11166726B2 (en) | 2011-02-04 | 2021-11-09 | University Of Massachusetts | Negative pressure wound closure device |
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