VACUUM ASSISTED DRESSINGS, SYSTEMS AND PUMPS FOR SURGICAL INCISIONS AND SEROMA MANAGEMENT
20180289871 ยท 2018-10-11
Inventors
Cpc classification
A61M1/915
HUMAN NECESSITIES
A61M1/63
HUMAN NECESSITIES
A61F13/0206
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
A61M1/98
HUMAN NECESSITIES
A61M1/815
HUMAN NECESSITIES
A61M1/743
HUMAN NECESSITIES
International classification
Abstract
A vacuum overdressing sealing a wound. The dressing has a layer of overdressing that is generally rectangular with a top side and a bottom side and two longer ends and two shorter ends. The overdressing layer has a port through which a vacuum can be pulled when the wound is sealed by the dressing. The port is located near one of the ends of the dressing.
Claims
1. A vacuum overdressing for sealing a wound comprising: a layer of overdressing; wherein the overdressing layer is generally rectangular having a top side and a bottom side, and defined by two longer ends and two shorter ends, and further wherein the overdressing layer has a port through which a vacuum can be pulled when the wound is sealed by the dressing; said port being located near one of the shorter ends of the dressing.
2. The vacuum overdressing of claim 1, further comprising: a sponge layer attached to the bottom side of the overdressing layer.
3. The vacuum overdressing of claim 2, wherein the sponge layer is integrally formed with the layer of overdressing.
4. The vacuum overdressing of claim 2, wherein the sponge layer is attached to the layer of overdressing by an adhesive.
5. The vacuum overdressing of claim 2, further comprising a layer of non-absorbent dressing attached to the sponge layer.
6. The vacuum overdressing of claim 1, further comprising a layer of non-absorbent dressing attached to the layer of overdressing.
7. The vacuum overdressing of claim 1 wherein the layer of overdressing is an adhesive film dressing.
8. The vacuum overdressing of claim 1 wherein the layer of overdressing is a hydrocolloid dressing.
9. The vacuum overdressing of claim 2, further comprising a second layer of overdressing between the first layer of overdressing and the sponge layer.
10. A vacuum overdressing for sealing a wound comprising: a layer of overdressing; wherein the overdressing layer is generally rectangular having a top side and a bottom side, and defined by two longer ends and two shorter ends, and further wherein the overdressing layer has a port through which a vacuum can be pulled when the wound is sealed by the dressing; said port being located near one of the longer ends of the dressing.
11. The vacuum overdressing of claim 10, further comprising: a sponge layer attached to the bottom side of the overdressing layer.
12. The vacuum overdressing of claim 11, wherein the sponge layer is integrally formed with the layer of overdressing.
13. The vacuum overdressing of claim 11, wherein the sponge layer is attached to the layer of overdressing by an adhesive.
14. The vacuum overdressing of claim 11, further comprising a layer of non-absorbent dressing attached to the sponge layer.
15. The vacuum overdressing of claim 10, further comprising a layer of non-absorbent dressing attached to the layer of overdressing.
16. The vacuum overdressing of claim 10 wherein the layer of overdressing is an adhesive film dressing.
17. The vacuum overdressing of claim 10 wherein the layer of overdressing is a hydrocolloid dressing.
18. The vacuum overdressing of claim 11, further comprising a second layer of overdressing between the first layer of overdressing and the sponge layer.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The foregoing aspects and many of the advantages of the disclosed embodiments will become more readily appreciated by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
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DETAILED DESCRIPTION
[0024] Complex surgical wounds are expensive and cause patients significant morbidity and, at times, death. Management of postoperative wounds and post-operative seromas encourage incision healing prior to the formation of complex wounds. Appropriate management of post-operative wounds after mesh placement may reduce the incidence of mesh infection. Mesh infection alone is costly and a source of morbidity and mortality. The present invention is particularly useful to manage high risk incisions before they become wounds and to promote healing of at-risk incisions.
[0025] Systems that applying a vacuum over a wound or incision to help drain fluid from the area to help promote healing and reduce the chance of infection are known. In order to apply known vacuum devices, a sealed area must be created in the desired area using various layers of dressing over the wound. Because various types of dressing are used and the whole area must be covered, creating of the sealed area is a time intensive process.
[0026] Known wound treatment systems that use negative pressure have a vacuum overlayer (i.e., a layer that has a port for connecting to a vacuum) that is square. Because they are not specifically shaped or designed for seroma management for surgical incisions, known vacuum overlayers impractical for post-operative incision treatment.
[0027] Known negative pressure systems that are marketed for use with incisions are single-use and do not allow a physician to monitor or inspect the incision or aspirate a seroma near an incision without removing and replacing the multiple layers of dressing that create a vacuum sealed area over the incision. Having a system that is specifically shaped for seroma management for incisions and that can reduce the time intensive procedure of replacing multiple layers of dressing will save time and cost.
[0028] High output seromas can output from between about 200 ml-500 ml of fluid in 24 hours. This type of volume will fill up the vacuum chambers of known portable vacuum pumps in less time than the vacuum treatment is desired. Removing and re-applying the multiple layers of dressing that created a sealed area over the incisions is a time intensive process for a surgeon or anyone else that treats wounds or seromas, e.g., another physician or a nurse. Having a seroma management system that can be used with high output seromas without the need to remove the sealed dressing to empty the vacuum chamber is desirable.
[0029] Finally, while managing the seroma under vacuum pressure, it can be desirable to treat or irrigate the area near the incision with saline or other medicated fluid from time to time. Having a system where the area can be rinsed without the need to remove the air sealed dressing will save time and cost.
[0030] The discussion will now turn to
[0031] As shown in
[0032] As shown in
[0033] As shown in
[0034] As shown in
[0035] The vacuum 28 creates negative pressure at a desired pressure. For example, standard pressures in would care range from about 100 mmHg to 200 mmHg, depending on the size of the incision or desired negative vacuum. Often, the desired initial negative pressure is about 125 mmHG. Preferably the pump is small enough to be portable so that the patient can use it for up to several days, even when the patient is mobile. Known disposable pumps create a fairly consistent pressure of around 125 mmHg. The vacuum 28 may be a manual pump. Alternatively, a battery powered pump device may also be used. A reservoir or container (not shown) for collecting the fluid is also integral with the vacuum 28. For known disposable vacuums, the pump is the container. When a negative pressure is applied by the vacuum, fluid from the seroma may be drained from the port in the dressing, through the tube to the collection reservoir in the pump 28.
[0036]
[0037] As shown in
[0038] In addition, the shape of the overdressing 40 allows a single layer of overdressing 40 to be used to seal an area around the incision 14. This helps reduce the time and effort of applying several other layers to seal the incision (e.g., layers 24 in
[0039] However, because the shape of the vacuum overdressing layer 40 covers the entire incision, other layers may be formed integrally with over dressing layer 40 to help protect or treat the incision. For example, a sponge layer (similar to layer 22 in
[0040] Other dressing layers can also be provided. For example, a second overdressing layer may be positioned between the sponge 22 and the layer 40. Additionally, a second non-absorbent dressing layer may be applied over the non-absorbent dressing layer that is applied over the wound.
[0041] As described herein, the vacuum 28 may be powered mechanically, by batteries or by AC electricity. In addition, the vacuum 28 may be disposable after a single use or a number of cycles for a given patient. The pump can also be adjustable to create the desired level of vacuum, ideally between about 100 and 200 mmHg, although lower or high vacuum levels may be desired for certain treatments.
[0042] In
[0043]
[0044] As shown in
[0045]
[0046] The deformed end of the tube 30 can be cut off to get a new clean, undeformed edge of the tube 30. The new edge can then be reattached to a valve 60 on a new pump 28 (or the same pump if it is drained and being re-used) so that the dressing does not have to be removed. Clipping the deformed end and using a new clean end helps maintain a good seal and allows the sealed overdressing to remain in place, thus avoiding the time intensive process of re-dressing and re-sealing the incision.
[0047]
[0048] When the vacuum is in use, the port 70 is sealed (not shown), e.g., with a cap, plug or similar structure, to prevent fluid from escaping from the pump 28. To drain fluid from the pump, the port 70 can be unsealed and connected to a biohazard bag or other receptacle, as shown in
[0049] Preferably, the tubing 72 and 76 is silicone tubing. Also, preferably tubing 72 is a smaller diameter than tubing 76. Pinch clamps 80 and 81 can also be provided to seal the tubing 72 and/or 76 when they are clamped, as desired to prevent fluid from flowing to or from the tubing or other components of the system.
[0050] To pull fluid from the vacuum 28 and into the bulb pump 74, clamp 80 is not clamped on (and does not seal) tube 72 and clamp 81 is clamped on (and seals) tube 76. In this configuration, when the bulb pump 74 is pumped, fluid flows from the vacuum 28, through tube 72 and into bulb pump 74.
[0051] To pump fluid into the receptacle 78, the clamps are changed so that clamp 80 is clamped on (and seals tube 72) and clamp 81 is not clamped on (and does not seal) tube 76. In this configuration, when the bulb 74 is pumped, fluid from the bulb 74 will flow through the tube 76 and into the container 78.
[0052]
[0053] In addition, to maintain the contents of the vacuum in a liquid state to facilitate evacuation into the bag, citrate 92 may be added to the chamber of the vacuum to keep it from coagulating. In addition, a congealer powder can be added to the biohazard bag to help convert the liquid to a congealed solid waste to reduce leakage and make it easier to seal.
[0054]
[0055] As shown in
[0056] After the overdressing layers 106, 108 and 110 are in place, the seroma can be drained with a needle at the three x locations 114 by inserting the needled through the layers 106, 108 and 110. The needle will puncture the seal created by the vacuum layer 106. However, after the seroma is drained and the needle is remove, layers 108 and 110 will re-seal, so that a seal is preserved under the entire dressing (layers 106, 108 and 110) and a vacuum can still be pulled by the pump through tube 112. This allows for aspiration of a seroma, without the time-consuming task of removing and re-applying one or more layers of vacuum dressing 106 in an airtight manner.
[0057] The self-sealing overdressing layer 108 is made of a moldable adhesive, that is sticky when warmed to body temperature, such as an adhesive layer sold under the trade name Eakin Cohesive. The seroma 104 is aspirated by inserting a needle through layers 110, 108, 106, 122 and 120, as well as the skin 100. After the seroma 104 has been aspirated, the needle is removed from all of the layers, and pressure can be applied to layer 108 to obliterate and seal the needle tract. Preferably the layer 110 is a clear adhesive layer in order to reinforce the defect created by needle tract over the site and to prevent the moldable layer 108 from becoming adherent to the patient's clothing or other objects in the environment, including dirt and debris.
[0058]
[0059]
[0060] A vacuum seal dressing layer 140 (similar to the vacuum seal layers 40 and 106 described above) is placed over an incision to form a sealed area around an incision. Other layers may be below the vacuum seal layer, e.g., a foam sponge layer (such as layer 122 described above) and a dressing layer (such as layer 120 described above).
[0061] Similar to the system described in
[0062] In addition, and similar to the system described in
[0063] When the vacuum is in use, the port 70 is sealed (not shown), e.g., with a cap, plug or similar structure, to prevent fluid from escaping from the pump 28. To drain fluid from the pump, the port 70 can be unsealed and connected to a biohazard bag or other receptacle. As described above, one end of tubing 72 can be connected to the port 70. The other end of the tubing 70 can be connected to a silicone bulb pump 74. The bulb can also be connected to an end of a second silicone tubing 76. The other end of the tubing 76 is connected, via a port 79, to a disposable biohazard bag 78. However any suitable container for collecting the fluid may be used. Alternatively, a container need not be connected, by fluid can be allowed to flow into another container or proper disposal area.
[0064] Preferably, the tubing 72 and 76 is silicone tubing. Also, preferably tubing 72 is a smaller diameter than tubing 76. Pinch clamps 80 and 81 can also be provided to seal the tubing 72 and/or 76 when they are clamped, as desired to prevent fluid from flowing to or from the tubing or other components of the system.
[0065] To pull fluid from the vacuum 28 and into the bulb pump 74, clamp 80 is not clamped on (and does not seal) tube 72 and clamp 81 is clamped on (and seals) tube 76. In this configuration, when the bulb pump 74 is pumped, fluid flows from the vacuum 28, through tube 72 and into bulb pump 74.
[0066] To pump fluid into the receptacle 78, the clamps are changed so that clamp 80 is clamped on (and seals tube 72) and clamp 81 is not clamped on (and does not seal) tube 76. In this configuration, when the bulb 74 is pumped, fluid from the bulb 74 will flow through the tube 76 and into the container 78.
[0067] In addition, in this system, the vacuum seal layer 140 can have a second port 142. The port can be used to inject fluid into the area over the incision to clean it. Prior to injecting the fluid, a pinch clamp can be used to seal the tube 30 to prevent the fluid from flowing out of the sealed area under the layer 140. A silicone tube 142 is attached to the port 10, which can be connected to a saline flush by way of an IV-lock device (or other connector) to allow the saline to be injected into the area around the incision. After the saline has been injected, the pinch clamp 142 can be applied to tube 144 to keep the saline in the area around the incision for a desired period of time. When the saline is desired to be removed, the pinch clamp 141 can be removed and the vacuum can apply negative pressure to drain the saline and other fluid from the area into the vacuum 28.
[0068]
[0069] When a vacuum sealed dressing is applied to an incision, or even after it is applied, the best location to drain a seroma with a needle, i.e., the location that will remove the most fluid, is not always known. The well 150 can be used over a vacuum dressing layer or area of a vacuum dressing layer that is not self-sealing and allows the needle to be inserted in a desired point on the sealed dressing, and, if needed, at multiple points on the sealed dressing.
[0070] The well 150 can be placed on top of a vacuum dressing layer 151 (
[0071] A needle can be inserted through the hole 158 and vacuum layer dressing 151 to drain the seroma. After the seroma has been drained, the needle is removed, and a layer of moldable self-sealing material 156 (similar to the self-sealing material layer 108 described above) can be placed inside the cut out. Then, a layer of film over dressing 154 is placed over the layer 152 and 154 to form a seal again. Pressure can be applied to the moldable self-sealing layer 156 prior to or after applying the film layer 154 in order to seal the hole 158. The ring provides support such that when pressure is applied to the layer 156, the layer 156 effectively seals the hole and the space in the cut-out.
[0072] Many different arrangements of the various components depicted, as well as components not shown, are possible without departing from the spirit and scope of the present disclosure. Embodiments of the present disclosure have been described with the intent to be illustrative rather than restrictive. Alternative embodiments will become apparent to those skilled in the art that do not depart from its scope. A skilled artisan may develop alternative means of implementing the aforementioned improvements without departing from the scope of the present disclosure.
[0073] It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations and are contemplated within the scope of the claims. Not all steps listed in the various figures need be carried out in the specific order described.