Patent Grant
12042361
Embodiments of the present invention relate generally to the treatment of wounds using negative pressure wound therapy and more specifically to wound treatment apparatuses including a fluidic connector for use therewith.
The treatment of open or chronic wounds that are too large to spontaneously close or otherwise fail to heal by means of applying negative pressure to the site of the wound is well known in the art. Negative pressure wound therapy (NPWT) systems currently known in the art commonly involve placing a cover that is impermeable or semi-permeable to fluids over the wound, using various means to seal the cover to the tissue of the patient surrounding the wound, and connecting a source of negative pressure (such as a vacuum pump) to the cover in a manner so that negative pressure is created and maintained under the cover. It is believed that such negative pressures promote wound healing by facilitating the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines bacteria. However, further improvements in NPWT are needed to fully realize the benefits of treatment.
Many different types of wound dressings are known for aiding in NPWT systems. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads or multi-layer wound dressings. One example of a multi-layer wound dressing is the PICO dressing, available from Smith & Nephew, which includes a superabsorbent layer beneath a backing layer to provide a canister-less system for treating a wound with NPWT. The wound dressing may be sealed to a suction port providing connection to a length of tubing, which may be used to pump fluid out of the dressing and/or to transmit negative pressure from a pump to the wound dressing.
The stiffness of certain suction ports in such close proximity to the wound site can adversely affect the healing process. Patient movement or pressure onto the wound dressing may bring the healing wound into contact with the inflexible suction port of the dressing. Such force can cause disturbance of a wound bed which can damage a wound site. This can potentially cause delays in healing of the wound site and discomfort for the patient.
It will also be appreciated that the tubing connected to the suction port is prone to obstruction. The tubing may become obstructed by movement of the patient, which may cause the tube to bend and form a kink or may place pressure onto the tubing, substantially or fully blocking the flow of fluid through the tubing. This can reduce or eliminate the negative pressure being transmitted to the wound site, and in embodiments employing a separate canister for fluid collection it can also result in accumulation of excess wound exudate at the wound site.
Further problems may arise when a suction port adhered to a top surface of a wound dressing is pulled away from the dressing. For example, if a tubing or conduit connected to the suction port is pulled in certain directions, the suction port may be peeled from the dressing. If the suction port is adhered to the dressing top surface by adhesive, such as an adhesive ring, when the suction port is compressed to the dressing top surface with the adhesive in between, this may cause localized peaks of adhesive. When a tubing or conduit is pulled to tug on the suction port, this may cause peeling of the suction port from the dressing. The localized peaks of adhesive may create areas of intense stress concentration which can lead to pin holing in the dressing after a small tug.
According to some embodiments there is provided a wound treatment apparatus comprising:
In some embodiments the reinforcement is configured to be positioned between the top surface of the cover layer and the lower surface of the fluidic connector. The lower surface of the fluidic connector may be configured to be adhered to the reinforcement. The reinforcement may be positioned between the top surface of the cover layer and the lower surface of the elongate conduit. In some embodiments the reinforcement may comprise a strip of adhesive tape. The strip of adhesive tape may be configured to be positioned between the sealing surface and an edge of the cover layer. In some embodiments the reinforcement may comprise a skirt configured to be positioned between the sealing surface and the top surface of the cover layer. The skirt may comprise an opening configured to be positioned over the aperture in the cover layer. In some embodiments the sealing surface is adhered to the top surface of the cover layer with a first adhesive, and the lower surface of the fluidic connector is adhered to the reinforcement with a second adhesive. The first adhesive may be an adhesive ring that surrounds the aperture in the cover layer, and the second adhesive may be one of a second adhesive ring surrounding the first adhesive ring and an adhesive layer on a lower surface of the elongate conduit. The reinforcement may be provided over the fluidic connector. The reinforcement provided over the fluidic connector may be an adhesive tape provided over the elongate conduit and adhered to the top surface of the cover layer on opposite sides of the elongate conduit. The reinforcement may be transparent. In some embodiments the sealing surface of the fluidic connector is provided at an enlarged distal end of the fluidic connector. In some embodiments the wound treatment apparatus may further comprise a spacer layer comprising a proximal end, an elongate middle portion and a distal end; a top layer constructed from a liquid impermeable material provided over the spacer layer; and a bottom layer constructed from a liquid impermeable material provided below the spacer layer. The top layer and the bottom layer may substantially enclose the spacer layer and one or more apertures in the bottom layer beneath the distal end of the spacer layer. The spacer layer may comprise a 3D fabric material. In some embodiments the fluidic connector further comprises a filter positioned across the opening in the sealing surface. In some embodiments the wound dressing may further comprise a wound contact layer and an absorbent layer for absorbing wound exudate. The absorbent layer may be positioned between the wound contact layer and the absorbent layer. The wound dressing may further comprises one or more transmission layers between the wound contact layer and the cover layer. The one or more transmission layers may comprise 3D fabric. In some embodiments the wound treatment apparatus may comprise a transmission layer beneath the absorbent layer.
According to some embodiments there is provided a wound treatment apparatus comprising:
In some embodiments the filter may be positioned between the sealing surface and the upper surface. The filter may be positioned between the upper surface and the cover layer. The filter may be positioned between the reinforcement layer and the cover layer. The filter may be positioned between the reinforcement layer and the cover layer. The sealing surface may be provided on a lower layer of the fluidic connector. The lower layer may comprise an opening that is positioned over the opening in the reinforcement layer, and the upper surface may be provided on an upper layer of the fluidic connector. The upper and lower layers may be adhered together. A spacer layer may be positioned between the upper and lower layers. In some embodiments the elongate conduit may comprise elongated portions of the upper layer, the spacer layer and the lower layer. The filter may be located between the spacer layer and the lower layer. The reinforcement layer may have an outer perimeter larger than an outer perimeter of the sealing surface. The reinforcement layer may comprise a generally circular ring. In some embodiments a first adhesive ring surrounding the opening in the reinforcement layer and surrounding the aperture in the cover layer may adhere the reinforcement layer to the cover layer, and a second adhesive ring surrounding the opening in the reinforcement layer may adhere the sealing surface to the reinforcement layer. The first adhesive ring may have a larger diameter than the second adhesive ring. The adhesive may adhere the sealing surface of the fluidic connector to both the reinforcement and to the top surface of the cover layer.
According to some embodiments there is provided an apparatus for providing negative pressure to a wound, the apparatus comprising:
Preferred embodiments disclosed herein relate to wound therapy for a human or animal body. Therefore, any reference to a wound herein can refer to a wound on a human or animal body, and any reference to a body herein can refer to a human or animal body. The term “wound” as used herein, in addition to having its broad ordinary meaning, includes any body part of a patient that may be treated using negative pressure. Wounds include, but are not limited to, open wounds, incisions, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like. Treatment of such wounds can be performed using negative pressure wound therapy, wherein a reduced or negative pressure can be applied to the wound to facilitate and promote healing of the wound. It will also be appreciated that the fluidic connector and methods as disclosed herein may be applied to other parts of the body, and are not necessarily limited to treatment of wounds.
Certain embodiments of this application related to a wound treatment apparatus employing a wound dressing and a fluidic connector, and to methods of using the same. Certain embodiments of this application relate to a fluidic connector and methods of using the same.
With reference initially to
As shown in
As illustrated in
Some embodiments of the wound contact layer 222 may also act as a carrier for an optional lower and upper adhesive layer (not shown). For example, a lower pressure sensitive adhesive may be provided on the lower surface 224 of the wound dressing 100 whilst an upper pressure sensitive adhesive layer may be provided on the upper surface 223 of the wound contact layer. The pressure sensitive adhesive, which may be a silicone, hot melt, hydrocolloid or acrylic based adhesive or other such adhesives, may be formed on both sides or optionally on a selected one or none of the sides of the wound contact layer. When a lower pressure sensitive adhesive layer is utilized may be helpful to adhere the wound dressing 100 to the skin around a wound site. In some embodiments, the wound contact layer may comprise perforated polyurethane film. The lower surface of the film may be provided with a silicone pressure sensitive adhesive and the upper surface may be provided with an acrylic pressure sensitive adhesive, which may help the dressing maintain its integrity. In some embodiments, a polyurethane film layer may be provided with an adhesive layer on both its upper surface and lower surface, and all three layers may be perforated together.
A layer 226 of porous material can be located above the wound contact layer 222. This porous layer, or transmission layer, 226 allows transmission of fluid including liquid and gas away from a wound site into upper layers of the wound dressing. In particular, the transmission layer 226 preferably ensures that an open air channel can be maintained to communicate negative pressure over the wound area even when the absorbent layer has absorbed substantial amounts of exudates. The layer 226 should preferably remain open under the typical pressures that will be applied during negative pressure wound therapy as described above, so that the whole wound site sees an equalized negative pressure. The layer 226 may be formed of a material having a three dimensional structure. For example, a knitted or woven spacer fabric (for example Baltex 7970 weft knitted polyester) or a non-woven fabric could be used.
In some embodiments, the transmission layer 226 comprises a 3D polyester spacer fabric layer including a top layer (that is to say, a layer distal from the wound-bed in use) which is a 84/144 textured polyester, and a bottom layer (that is to say, a layer which lies proximate to the wound bed in use) which is a 10 denier flat polyester and a third layer formed sandwiched between these two layers which is a region defined by a knitted polyester viscose, cellulose or the like monofilament fiber. Other materials and other linear mass densities of fiber could of course be used.
Whilst reference is made throughout this disclosure to a monofilament fiber it will be appreciated that a multistrand alternative could of course be utilized. The top spacer fabric thus has more filaments in a yarn used to form it than the number of filaments making up the yarn used to form the bottom spacer fabric layer.
This differential between filament counts in the spaced apart layers helps control moisture flow across the transmission layer. Particularly, by having a filament count greater in the top layer, that is to say, the top layer is made from a yarn having more filaments than the yarn used in the bottom layer, liquid tends to be wicked along the top layer more than the bottom layer. In use, this differential tends to draw liquid away from the wound bed and into a central region of the dressing where the absorbent layer 221 helps lock the liquid away or itself wicks the liquid onwards towards the cover layer where it can be transpired.
Preferably, to improve the liquid flow across the transmission layer 226 (that is to say perpendicular to the channel region formed between the top and bottom spacer layers, the 3D fabric may be treated with a dry cleaning agent (such as, but not limited to, Perchloro Ethylene) to help remove any manufacturing products such as mineral oils, fats and/or waxes used previously which might interfere with the hydrophilic capabilities of the transmission layer. In some embodiments, an additional manufacturing step can subsequently be carried in which the 3D spacer fabric is washed in a hydrophilic agent (such as, but not limited to, Feran Ice 30 g/l available from the Rudolph Group). This process step helps ensure that the surface tension on the materials is so low that liquid such as water can enter the fabric as soon as it contacts the 3D knit fabric. This also aids in controlling the flow of the liquid insult component of any exudates.
A layer 221 of absorbent material is provided above the transmission layer 226. The absorbent material, which comprise a foam or non-woven natural or synthetic material, and which may optionally comprise a super-absorbent material, forms a reservoir for fluid, particularly liquid, removed from the wound site. In some embodiments, the layer 10 may also aid in drawing fluids towards the backing layer 220.
The material of the absorbent layer 221 may also prevent liquid collected in the wound dressing 100 from flowing freely within the dressing, and preferably acts so as to contain any liquid collected within the dressing. The absorbent layer 221 also helps distribute fluid throughout the layer via a wicking action so that fluid is drawn from the wound site and stored throughout the absorbent layer. This helps prevent agglomeration in areas of the absorbent layer. The capacity of the absorbent material must be sufficient to manage the exudates flow rate of a wound when negative pressure is applied. Since in use the absorbent layer experiences negative pressures the material of the absorbent layer is chosen to absorb liquid under such circumstances. A number of materials exist that are able to absorb liquid when under negative pressure, for example superabsorber material. The absorbent layer 221 may typically be manufactured from ALLEVYN™ foam, Freudenberg 114-224-4 and/or Chem-Posite™ 11C-450. In some embodiments, the absorbent layer 221 may comprise a composite comprising superabsorbent powder, fibrous material such as cellulose, and bonding fibers. In a preferred embodiment, the composite is an airlaid, thermally-bonded composite.
In some embodiments, the absorbent layer 221 is a layer of non-woven cellulose fibers having super-absorbent material in the form of dry particles dispersed throughout. Use of the cellulose fibers introduces fast wicking elements which help quickly and evenly distribute liquid taken up by the dressing. The juxtaposition of multiple strand-like fibers leads to strong capillary action in the fibrous pad which helps distribute liquid. In this way, the super-absorbent material is efficiently supplied with liquid. The wicking action also assists in bringing liquid into contact with the upper cover layer to aid increase transpiration rates of the dressing.
An aperture, hole, or orifice 227 is preferably provided in the backing layer 220 to allow a negative pressure to be applied to the dressing 100. The fluidic connector 110 is preferably attached or sealed to the top of the backing layer 220 over the orifice 227 made into the dressing 100, and communicates negative pressure through the orifice 227. A length of tubing may be coupled at a first end to the fluidic connector 110 and at a second end to a pump unit (not shown) to allow fluids to be pumped out of the dressing. Where the fluidic connector is adhered to the top layer of the wound dressing, a length of tubing may be coupled at a first end of the fluidic connector such that the tubing, or conduit, extends away from the fluidic connector parallel or substantially to the top surface of the dressing. The fluidic connector 110 may be adhered and sealed to the backing layer 220 using an adhesive such as an acrylic, cyanoacrylate, epoxy, UV curable or hot melt adhesive. The fluidic connector 110 may be formed from a soft polymer, for example a polyethylene, a polyvinyl chloride, a silicone or polyurethane having a hardness of 30 to 90 on the Shore A scale. In some embodiments, the fluidic connector 110 may be made from a soft or conformable material.
Preferably the absorbent layer 221 includes at least one through hole 228 located so as to underlie the fluidic connector 110. The through hole 228 may in some embodiments be the same size as the opening 227 in the backing layer, or may be bigger or smaller. As illustrated in
The aperture or through-hole 228 is preferably provided in the absorbent layer 221 beneath the orifice 227 such that the orifice is connected directly to the transmission layer 226. This allows the negative pressure applied to the fluidic connector 110 to be communicated to the transmission layer 226 without passing through the absorbent layer 221. This ensures that the negative pressure applied to the wound site is not inhibited by the absorbent layer as it absorbs wound exudates. In other embodiments, no aperture may be provided in the absorbent layer 221, or alternatively a plurality of apertures underlying the orifice 227 may be provided. In further alternative embodiments, additional layers such as another transmission layer or an obscuring layer such as described in International Patent Publication WO2014020440 may be provided over the absorbent layer 221 and beneath the backing layer 220.
The backing layer 220 is preferably gas impermeable, but moisture vapor permeable, and can extend across the width of the wound dressing 100. The backing layer 220, which may for example be a polyurethane film (for example, Elastollan SP9109) having a pressure sensitive adhesive on one side, is impermeable to gas and this layer thus operates to cover the wound and to seal a wound cavity over which the wound dressing is placed. In this way an effective chamber is made between the backing layer 220 and a wound site where a negative pressure can be established. The backing layer 220 is preferably sealed to the wound contact layer 222 in a border region around the circumference of the dressing, ensuring that no air is drawn in through the border area, for example via adhesive or welding techniques. The backing layer 220 protects the wound from external bacterial contamination (bacterial barrier) and allows liquid from wound exudates to be transferred through the layer and evaporated from the film outer surface. The backing layer 220 preferably comprises two layers; a polyurethane film and an adhesive pattern spread onto the film. The polyurethane film is preferably moisture vapor permeable and may be manufactured from a material that has an increased water transmission rate when wet. In some embodiments the moisture vapor permeability of the backing layer increases when the backing layer becomes wet. The moisture vapor permeability of the wet backing layer may be up to about ten times more than the moisture vapor permeability of the dry backing layer.
The absorbent layer 221 may be of a greater area than the transmission layer 226, such that the absorbent layer overlaps the edges of the transmission layer 226, thereby ensuring that the transmission layer does not contact the backing layer 220. This provides an outer channel of the absorbent layer 221 that is in direct contact with the wound contact layer 222, which aids more rapid absorption of exudates to the absorbent layer. Furthermore, this outer channel ensures that no liquid is able to pool around the circumference of the wound cavity, which may otherwise seep through the seal around the perimeter of the dressing leading to the formation of leaks. As illustrated in
As shown in
In particular for embodiments with a single fluidic connector 110 and through hole, it may be preferable for the fluidic connector 110 and through hole to be located in an off-center position as illustrated in
Turning now to the fluidic connector 110, preferred embodiments comprise a sealing surface 216, a bridge 211 (corresponding to bridge 120 in
Some embodiments may further comprise an optional second fluid passage positioned above the first fluid passage 212. For example, some embodiments may provide for an air leak may be disposed at the proximal end of the top layer that is configured to provide an air path into the first fluid passage 212 and dressing 100 similar to the suction adapter 701 as shown in
Preferably, the fluid passage 212 is constructed from a compliant material that is flexible and that also permits fluid to pass through it if the spacer is kinked or folded over. Suitable materials for the fluid passage 212 include without limitation foams, including open-cell foams such as polyethylene or polyurethane foam, meshes, 3D knitted fabrics, non-woven materials, and fluid channels. In some embodiments, the fluid passage 212 may be constructed from materials similar to those described above in relation to the transmission layer 226. Advantageously, such materials used in the fluid passage 212 not only permit greater patient comfort, but may also provide greater kink resistance, such that the fluid passage 212 is still able to transfer fluid from the wound toward the source of negative pressure while being kinked or bent.
In some embodiments, the fluid passage 212 may be comprised of a wicking fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970®, or Gehring 879®) or a nonwoven fabric. These materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure and/or vented air to the wound site, and may also confer a degree of kinking or occlusion resistance to the fluid passage 212. In some embodiments, the wicking fabric may have a three-dimensional structure, which in some cases may aid in wicking fluid or transmitting negative pressure. In certain embodiments, including wicking fabrics, these materials remain open and capable of communicating negative pressure to a wound area under the typical pressures used in negative pressure therapy, for example between 40 to 150 mmHg. In some embodiments, the wicking fabric may comprise several layers of material stacked or layered over each other, which may in some cases be useful in preventing the fluid passage 212 from collapsing under the application of negative pressure. In other embodiments, the wicking fabric used in the fluid passage 212 may be between 1.5 mm and 6 mm; more preferably, the wicking fabric may be between 3 mm and 6 mm thick, and may be comprised of either one or several individual layers of wicking fabric. In other embodiments, the fluid passage 212 may be between 1.2-3 mm thick, and preferably thicker than 1.5 mm. Some embodiments, for example a suction adapter used with a dressing which retains liquid such as wound exudate, may employ hydrophobic layers in the fluid passage 212, and only gases may travel through the fluid passage 212. Additionally, and as described previously, the materials used in the system are preferably conformable and soft, which may help to avoid pressure ulcers and other complications which may result from a wound treatment system being pressed against the skin of a patient.
Preferably, the filter element 214 is impermeable to liquids, but permeable to gases, and is provided to act as a liquid barrier and to ensure that no liquids are able to escape from the wound dressing 100. The filter element 214 may also function as a bacterial barrier. Typically the pore size is 0.2 μm. Suitable materials for the filter material of the filter element 214 include 0.2 micron Gore™ expanded PTFE from the MMT range, PALL Versapore™ 200R, and Donaldson™ TX6628. Larger pore sizes can also be used but these may require a secondary filter layer to ensure full bioburden containment. As wound fluid contains lipids it is preferable, though not essential, to use an oleophobic filter membrane for example 1.0 micron MMT-332 prior to 0.2 micron MMT-323. This prevents the lipids from blocking the hydrophobic filter. The filter element can be attached or sealed to the port and/or the cover film over the orifice. For example, the filter element 214 may be molded into the fluidic connector 110, or may be adhered to one or both of the top of the cover layer and bottom of the suction adapter 110 using an adhesive such as, but not limited to, a UV cured adhesive.
It will be understood that other types of material could be used for the filter element 214. More generally a microporous membrane can be used which is a thin, flat sheet of polymeric material, this contains billions of microscopic pores. Depending upon the membrane chosen these pores can range in size from 0.01 to more than 10 micrometers. Microporous membranes are available in both hydrophilic (water filtering) and hydrophobic (water repellent) forms. In some embodiments of the invention, filter element 214 comprises a support layer and an acrylic co-polymer membrane formed on the support layer. Preferably the wound dressing 100 according to certain embodiments of the present invention uses microporous hydrophobic membranes (MHMs). Numerous polymers may be employed to form MHMs. For example, the MHMs may be formed from one or more of PTFE, polypropylene, PVDF and acrylic copolymer. All of these optional polymers can be treated in order to obtain specific surface characteristics that can be both hydrophobic and oleophobic. As such these will repel liquids with low surface tensions such as multi-vitamin infusions, lipids, surfactants, oils and organic solvents.
MHMs block liquids whilst allowing air to flow through the membranes. They are also highly efficient air filters eliminating potentially infectious aerosols and particles. A single piece of MHM is well known as an option to replace mechanical valves or vents. Incorporation of MHMs can thus reduce product assembly costs improving profits and costs/benefit ratio to a patient.
The filter element 214 may also include an odor absorbent material, for example activated charcoal, carbon fiber cloth or Vitec Carbotec-RT Q2003073 foam, or the like. For example, an odor absorbent material may form a layer of the filter element 214 or may be sandwiched between microporous hydrophobic membranes within the filter element. The filter element 214 thus enables gas to be exhausted through the orifice. Liquid, particulates and pathogens however are contained in the dressing.
The wound dressing 100 may comprise spacer elements 215 in conjunction with the fluidic connector 110 and the filter 214. With the addition of such spacer elements 215 the fluidic connector 110 and filter 214 may be supported out of direct contact with the absorbent layer 220 and/or the transmission layer 226. The absorbent layer 220 may also act as an additional spacer element to keep the filter 214 from contacting the transmission layer 226. Accordingly, with such a configuration contact of the filter 214 with the transmission layer 226 and wound fluids during use may thus be minimized.
In particular for embodiments with a single fluidic connector 110 and through hole, it may be preferable for the fluidic connector 110 and through hole to be located in an off-center position as illustrated in
After the skin surrounding the wound site 400 is dry, and with reference now to
With reference now to
Turning to
Treatment of the wound site 400 preferably continues until the wound has reached a desired level of healing. In some embodiments, it may be desirable to replace the dressing 100 after a certain time period has elapsed, or if the dressing is full of wound fluids. During such changes, the pump 150 may be kept, with just the dressing 100 being changed.
Further details of dressings and other apparatuses that may be used with the, fluidic connectors described herein include, but are not limited to, dressings described in International Patent Publication WO 2012020440 and WO2014020443, the entireties of which are hereby incorporated by reference.
The bottom layer 540 may comprise an elongate bridge portion 544, an enlarged (e.g., rounded or circular) sealing portion 545, and an orifice 541. In some embodiments a plurality of orifices may be provided in the bottom layer. Some embodiments of the rounded sealing portion 545 may comprise a layer of adhesive, for example a pressure sensitive adhesive, on the lower surface for use in sealing the fluidic connector 500 to a dressing. For example, the fluidic connector may be sealed to a cover layer of the dressing. The orifice 541 in the bottom layer 540 of the port 500 may be aligned with an orifice in the cover layer of the dressing in order to transmit negative pressure through the dressing and into a wound site.
The top layer 515 may be substantially the same shape as the bottom layer in that it comprises an elongate bridge 514 and an enlarged (e.g., rounded or circular) portion 545. The top layer 515 and the bottom layer 545 may be sealed together, for example by heat welding. In some embodiments, the bottom layer 545 may be substantially flat and the top layer 515 may be slightly larger than the bottom layer 545 in order to accommodate the height of the spacer layer 520 and seal to the bottom layer 545. In other embodiments, the top layer 515 and bottom layer 3145 may be substantially the same size, and the layers may be sealed together approximately at the middle of the height of the spacer layer 520. In some embodiments, the elongate bridge portions 544, 514 may have a length of 10 cm (or about 10 cm) or more, more preferably a length of 20 cm (or about 20 cm) or more and in some embodiments, may be about 69 cm (or 27 cm) long. Some embodiments of the entire fluidic connector, from a proximal-most edge of the top and bottom layers to a distal-most edge of the top and bottom layers, may be between 20 cm and 80 cm (or about 20 cm to about 80 cm) long, more preferably about 60 cm and 80 cm (or between about 60 cm and about 80 cm) long, for example about 70 cm long. In some embodiments, the elongate bridge portions may have a width of between 1 cm and 4 cm (or between about 1 cm and about 4 cm), and in one embodiment, is about 2.5 cm wide. The ratio of the length of the elongate bridge portions 544, 514 to their widths may in some embodiments exceed 6:1, and may more preferably exceed 8:1 or even 10:1. The diameter of the circular portion 545, 515 may be about 3.5 cm in some embodiments.
The bottom and top layers may comprise at least one layer of a flexible film, and in some embodiments may be transparent. Some embodiments of the bottom layer 540 and top layer 515 may be polyurethane, and may be liquid impermeable.
The fluidic connector 500 may comprise a spacer layer 520, such as the 3D fabric discussed above, positioned between the lower layer 540 and the top layer 510. The spacer layer 520 may be made of any suitable material, for example material resistant to collapsing in at least one direction, thereby enabling effective transmission of negative pressure therethrough. Instead of or in addition to the 3D fabric discussed above, some embodiments of the spacer layer 520 may comprise a fabric configured for lateral wicking of fluid, which may comprise viscose, polyester, polypropylene, cellulose, or a combination of some or all of these, and the material may be needle-punched. Some embodiments of the spacer layer 520 may comprise polyethylene in the range of 40-160 grams per square meter (gsm) (or about 40 to about 160 gsm), for example 80 (or about 80) gsm. Such materials may be constructed so as to resist compression under the levels of negative pressure commonly applied during negative pressure therapy.
The spacer layer 520 may comprise an elongate bridge portion 524, an enlarged (e.g., rounded or circular) portion 525, and may optionally include a fold 521. In some embodiments, the elongate bridge portion may have dimensions in the same ranges as the bridge portions of the upper and lower layers described above though slightly smaller, and in one embodiment is about 25.5 cm long and 1.5 cm wide. Similarly, the diameter of the circular portion 525 may be slightly smaller than the diameters of the enlarged ends 545, 515, and in one embodiment is about 2 cm. Some embodiments of the spacer layer 520 may have adhesive on one or both of its proximal and distal ends (e.g., one or more dabs of adhesive) in order to secure the spacer layer 520 to the top layer 510 and/or the bottom layer 540. Adhesive may also be provided along a portion or the entire length of the spacer layer. In other embodiments, the spacer layer 520 may be freely movable within the sealed chamber of the top and bottom layers.
The fold 521 of the spacer layer may make the end of the fluidic connector 500 softer and therefore more comfortable for a patient, and may also help prevent the conduit 550 from blockage. The fold 521 may further protect the end of the conduit 550 from being occluded by the top or bottom layers. The fold 521 may, in some embodiments, be between 1 cm and 3 cm (or between about 1 cm and about 3 cm) long, and in one embodiment is 2 cm (or about 2 cm) long. The spacer layer may be folded underneath itself that is toward the bottom layer 540, and in other embodiments may be folded upward toward the top layer 510. Other embodiments of the spacer layer 520 may contain no fold. A slot or channel 522 may extend perpendicularly away from the proximal end of the fold 521, and the conduit 550 may rest in the slot or channel 522. In some embodiments the slot 522 may extend through one layer of the fold, and in others it may extend through both layers of the fold. The slot 522 may, in some embodiments, be 1 cm (or about 1 cm) long. Some embodiments may instead employ a circular or elliptical hole in the fold 521. The hole may face proximally so that the conduit 550 may be inserted into the hole and rest between the folded layers of spacer fabric. In some embodiments, the conduit 550 may be adhered to the material of the fold 521, while in other embodiments it may not.
The fluidic connector 500 may have a filter element 530 located adjacent the orifice 541, and as illustrated is located between the lower layer 540 and the spacer layer 520. The filter element 530 may be positioned across the opening or orifice of the fluidic connector 500. The filter element 530 is impermeable to liquids, but permeable to gases. The filter element may be similar to the element described above with respect to
The proximal end of the fluidic connector 500 may be connected to the distal end of a conduit 550. The conduit 550 may comprise one or more circular ribs 551. The ribs 551 may be formed in the conduit 550 by grooves in a mold during the manufacturing of the conduit. During heat welding of the upper and lower layers 515, 545 melted material from those layers may flow around the ribs 551, advantageously providing a stronger connection between the conduit 550 and the layers. As a result, it may be more difficult to dislodge the conduit 550 out from between the layers during use of the fluidic connector 500.
The proximal end of the conduit 550 may be optionally attached to a coupling 560. The coupling 560 may be used to connect the fluidic connector 500 to a source of negative pressure, or in some embodiments to an extension conduit which may in turn be connected to a source of negative pressure. As explained in more detail below with respect to
The bottom layer 1740 may comprise an elongate bridge portion 1744, an enlarged (e.g., rounded or circular) sealing portion 1745, and an orifice 1741. In some embodiments a plurality of orifices may be provided in the bottom layer. Some embodiments of the rounded sealing portion 1745 may comprise a layer of adhesive, for example a pressure sensitive adhesive, on the lower surface for use in sealing the fluidic connector 1700 to a dressing. The orifice 1741 in the bottom layer 1740 of the port 1700 may be aligned with an orifice in the cover layer of a dressing in order to transmit negative pressure through the dressing and into a wound site. In some embodiments the wound dressing may be substantially identical to the dressing as described in International Patent Publication WO2013175306, which is incorporated by reference in its entirety.
The top layer 1715 may be substantially the same shape as the bottom layer in that it comprises an elongate bridge 1714 and an enlarged (e.g., rounded or circular) portion 1715. The top layer 1715 and the bottom layer 1745 may be sealed together, for example by heat welding. In some embodiments, the bottom layer 1745 may be substantially flat and the top layer 1715 may be slightly larger than the bottom layer 1745 in order to accommodate the height of the spacer layer 1720 and seal to the bottom layer 1745. In other embodiments, the top layer 1715 and bottom layer 1745 may be substantially the same size, and the layers may be sealed together approximately at the middle of the height of the spacer layer 1720. In some embodiments, the elongate bridge portions 1744, 1714 may have a length of 10 cm (or about 10 cm) or more, more preferably a length of 20 cm (or about 20 cm) or more and in some embodiments, may be about 27 cm long. In some embodiments, the elongate bridge portions may have a width of between 1 cm and 4 cm (or between about 1 cm and about 4 cm), and in one embodiment, is about 2.5 cm wide. The ratio of the length of the elongate bridge portions 1744, 1714 to their widths may in some embodiments exceed 6:1, and may more preferably exceed 8:1 or even 10:1. The diameter of the circular portion 1745, 1715 may be about 3.5 cm in some embodiments.
The bottom and top layers may comprise at least one layer of a flexible film, and in some embodiments may be transparent. Some embodiments of the bottom layer 1740 and top layer 1715 may be polyurethane, and may be liquid impermeable.
The fluidic connector 1700 may comprise a spacer layer 1720, such as the 3D fabric discussed above, positioned between the lower layer 1740 and the top layer 1710. The spacer layer 1720 may be made of any suitable material, for example material resistant to collapsing in at least one direction, thereby enabling effective transmission of negative pressure therethrough. The spacer layer 1720 may comprise an enlarged (e.g., rounded or circular) portion 1725, and may optionally include a fold 1721. In some embodiments, the elongate bridge portion may have dimensions in the same ranges as the bridge portions of the upper and lower layers described above though slightly smaller, and in one embodiment is about 25.5 cm long and 1.5 cm wide. Similarly, the diameter of the circular portion 1725 may be slightly smaller than the diameters of the enlarged ends 1745, 1715, and in one embodiment is about 2 cm. Some embodiments of the spacer layer 1720 may have adhesive on one or both of its proximal and distal ends (e.g., one or more dabs of adhesive) in order to secure the spacer layer 1720 to the top layer 1710 and/or the bottom layer 1740. Adhesive may also be provided along a portion or the entire length of the spacer layer. In other embodiments, the spacer layer 1720 may be freely movable within the sealed chamber of the top and bottom layers.
The fold 1721 of the spacer fabric may make the end of the fluidic connector 1700 softer and therefore more comfortable for a patient, and may also help prevent the conduit 1750 from blockage. The fold 1721 may further protect the end of the conduit 1750 from being occluded by the top or bottom layers. The fold 1721 may, in some embodiments, be between 1 cm and 3 cm (or between about 1 cm and about 3 cm) long, and in one embodiment is 2 cm (or about 2 cm) long. The spacer fabric may be folded underneath itself, that is toward the bottom layer 1740, and in other embodiments may be folded upward toward the top layer 1710. Other embodiments of the spacer layer 1720 may contain no fold. A slot or channel 3522 may extend perpendicularly away from the proximal end of the fold 1721, and the conduit 1750 may rest in the slot or channel 1722. In some embodiments the slot 1722 may extend through one layer of the fold, and in others it may extend through both layers of the fold. The slot 1722 may, in some embodiments, be 1 cm (or about 1 cm) long. Some embodiments may instead employ a circular or elliptical hole in the fold 1721. The hole may face proximally so that the conduit 1750 may be inserted into the hole and rest between the folded layers of spacer fabric. In some embodiments, the conduit 1750 may be adhered to the material of the fold 1721, while in other embodiments it may not.
The fluidic connector 1700 may have a filter element 1730 located adjacent the orifice 1741, and as illustrated is located between the lower layer 1740 and the spacer layer 1720. As illustrated, the filter element 1730 may have a round or disc shape. The filter element 1730 is impermeable to liquids, but permeable to gases. The filter element 1730 can act as a liquid barrier, to substantially prevent or inhibit liquids from escaping from the wound dressing, as well as an odor barrier. The filter element 1730 may also function as a bacterial barrier. In some embodiments, the pore size of the filter element 1730 can be approximately 0.2 μm. Suitable materials for the filter material of the filter element include 0.2 micron Gore™ expanded PTFE from the MMT range, PALL Versapore™ B200R, and Donaldson™ TX6628. The filter element 1730 thus enables gas to be exhausted through the orifice. Liquid, particulates and pathogens however are contained in the dressing. Larger pore sizes can also be used but these may require a secondary filter layer to ensure full bioburden containment. As wound fluid contains lipids it is preferable, though not essential, to use an oleophobic filter membrane for example 1.0 micron MMT-332 prior to 0.2 micron MMT-323. This prevents the lipids from blocking the hydrophobic filter. In some embodiments, the filter element 1730 may be adhered to one or both of top surface of the bottom layer 1740 and the bottom surface of the spacer layer 1720 using an adhesive such as, but not limited to, a UV cured adhesive. In other embodiments, the filter 1730 may be welded to the inside of the spacer layer 1720 and to the top surface of the bottom layer 1740. The filter may also be provided adjacent the orifice on a lower surface of the bottom layer 1740. Other possible details regarding the filter are disclosed in U.S. Patent Pub. No. 2011/0282309 which is incorporated by reference herein.
The proximal end of the fluidic connector 1700 may be connected to the distal end of a conduit 1750. The conduit 1750 may comprise one or more circular ribs 1751. The ribs 1751 may be formed in the conduit 1750 by grooves in a mold during the manufacturing of the conduit. During heat welding of the upper and lower layers 1715, 1745 melted material from those layers may flow around the ribs 1751, advantageously providing a stronger connection between the conduit 1750 and the layers. As a result, it may be more difficult to dislodge the conduit 1750 out from between the layers during use of the fluidic connector 1700.
The proximal end of the conduit 1750 may be optionally attached to a coupling 1760. The coupling 1760 may be used to connect the fluidic connector 1700 to a source of negative pressure, or in some embodiments to an extension conduit which may in turn be connected to a source of negative pressure. The distal end of the conduit 1750, which is inserted into the spacer layer 1720, may be shaped in such a way to reduce the possibility of occlusion.
As introduced above, problems may arise when a fluidic connector or suction port adhered to a top surface of a wound dressing is pulled away from the dressing. For example, a fluidic connector may be adhered to the top surface of a wound dressing via an applicator or sealing surface, as described herein above. The applicator may be adhered to the cover layer of the dressing by an adhesive, such as an adhesive ring. When the applicator is compressed to the dressing top surface with the adhesive in between, localized peaks of adhesive may form. Where the fluidic connector is adhered to the top layer of the wound dressing, an elongate conduit such as the bridge described above, or a length of tubing coupled to a proximal end of the fluidic connector, may extend away from the applicator in a direction parallel or substantially parallel with the top surface of the dressing. If the fluidic connector or elongate conduit is pulled in certain directions, the localized peaks of adhesive may create areas of intense stress concentration which can lead to pin holing in the dressing after a small tug, which can cause undesirable leaks. Additionally, in some instances the tubing or conduit coupled to the fluidic connector may be bent backwards 180° during use such that a small tug can cause peeling of the fluidic connector away from the dressing.
The reinforcement 1901 may comprise any suitable high strength flexible film, tape or fabric such that when adhered to the wound dressing 100, the fluidic connector 110 is able to withstand a pull force of about 15 N without creating pinholes in the top layer of the wound dressing 100. The reinforcement 1901 may comprise a polymer or plastic material such as polyurethane (PU), polyethylene terephthalate (PET), Nylon, or PVCI. The reinforcement 1901 may alternatively comprise polyethylene (PE) or polypropylene (PP) where an appropriate adhesive is used with the reinforcement. The reinforcement may comprise a polymer film or a woven or non-woven fabric material.
The reinforcement 1901 may further comprise an adhesive on the lower, wound-facing surface for use in sealing the reinforcement to a wound dressing. The adhesive may be, for example a pressure sensitive adhesive, or a UV curable adhesive such as Loctite 4011-SG adhesive. In certain embodiments the relative stiffness of the reinforcement 1901 compared to the top layer of the wound dressing 100 or sealing surface of the fluidic connector may allow for an even coating of adhesive to be applied to the reinforcement. An even coating of adhesive may not comprise sharp outcrop or peaks, and may be a substantially uniform coating of adhesive. The adhesive coating may cover substantially the entire lower surface of the reinforcement 1901. In other embodiments, a separate adhesive or glue layer may be applied to either the wound dressing 100 or the reinforcement 1901 prior to adhering the reinforcement 1901 to the wound dressing 100. Further, the elongate bridge 211 and/or the sealing surface 216 of the fluidic connector 110 may also comprise an adhesive for use in sealing the fluidic connector to the reinforcement 1901 and the wound dressing 100.
As shown in
As depicted in
With reference again to
The reinforcement 1901 as described above may serve to more evenly distribute the stresses applied to the top surface of a wound dressing when a fluidic connector adhered thereto is pulled away from the dressing. Rather than focusing areas of intense stress at localized peaks of adhesive, the reinforcement applies the pulling stress to a larger area of the top layer of the dressing. By distributing the pulling load over a larger area of the top layer, the risk of pin holing in the dressing after a small tug is greatly reduced.
As shown in
The reinforcement 2001 may comprise any suitable high strength non-porous flexible film, tape or fabric such that when adhered to the wound dressing 100, the fluidic connector 110 is able to withstand a pull force of about 15 N without creating pinholes in the top layer of the wound dressing 100. The reinforcement 2001 may comprise PU, PET, Nylon, or PVCI. The reinforcement 2001 may comprise PE or PP where an appropriate adhesive is used with the reinforcement.
The reinforcement 2001 may further comprise an adhesive on the lower, wound-facing surface for use in sealing the reinforcement to a wound dressing. The adhesive may be, for example a pressure sensitive adhesive, or a UV curable adhesive such as Loctite 4011-SG adhesive. In certain embodiments the relative stiffness of the reinforcement 2001 compared to the top layer of the wound dressing 100 may allow for an even coating of adhesive to be applied to the reinforcement. An even coating of adhesive may not comprise sharp outcrop or peaks. The adhesive coating may cover substantially the entire lower surface of the reinforcement 2001.
As shown in
In other embodiments, a separate adhesive or glue layer may be applied to either the wound dressing 100 or the reinforcement 2001 prior to adhering the reinforcement 2001 to the wound dressing 100. Further, the sealing surface 216 of the fluidic connector 110 may also comprise an adhesive for use in adhering the sealing surface 216 of the fluidic connector 110 to the reinforcement 2001 and optionally the wound dressing 2010.
As shown in
In certain embodiments the reinforcement skirt 2001 is adhered to the sealing surface 216 by a first ring of adhesive that is smaller than a second, larger ring of adhesive which may be applied to the wound-facing surface of the skirt 2001 and is used to adhere the skirt 2001 to the backing layer of the wound dressing 100. Because the spacer 520 may cause the lower layer 540 of the fluidic connector to not be perfectly flat, this first ring of adhesive between the sealing surface and the reinforcement skirt may be positioned directly below the enlarged end of the spacer element 520, while the second, larger ring of adhesive between the skirt and the wound dressing may be positioned beyond the enlarged end of the spacer element.
As depicted in
With reference again to
The reinforcement 2001 as described above may serve to more evenly distribute the stresses applied to the top layer of a wound dressing when a fluidic connector adhered thereto is pulled away from the dressing. Rather than focusing areas of intense stress at localized peaks of adhesive, the reinforcement applies the pulling stress to a larger area of the top layer of the dressing. By distributing the pulling load over a larger area of the top layer, the risk of pin holing in the dressing after a small tug is greatly reduced.
The reinforcement 2101 may comprise any suitable high strength flexible film, tape or fabric such that when adhered to the wound dressing 100, the fluidic connector 110 is able to withstand a pull force of about 15 N without creating pinholes in the top layer of the wound dressing 100. The reinforcement 2101 may comprise PU, PET, Nylon, or PVCI. The reinforcement 2101 may comprise PE or PP where an appropriate adhesive is used with the reinforcement. The reinforcement may comprise a polymer film or a woven or non-woven fabric material.
The reinforcement 2101 may further comprise an adhesive on the lower, wound-facing surface for use in sealing the reinforcement to a wound dressing. The adhesive may be, for example a pressure sensitive adhesive, or a UV curable adhesive such as Loctite 4011-SG adhesive. In certain embodiments the relative stiffness of the reinforcement 2101 compared to the top layer of the wound dressing 2110 may allow for an even coating of adhesive to be applied to the reinforcement. An even coating of adhesive may not comprise sharp outcrop or peaks. The adhesive coating may cover substantially the entire lower surface of the reinforcement 2101. Further, the sealing surface of the fluidic connector 2100 may also comprise an adhesive for use in sealing the sealing surface of fluidic connector to the wound dressing 2110 over an orifice therein. In some embodiments the adhesive on the lower surface of the reinforcement 2101 may be the same as the adhesive on the sealing surface 216 of the fluidic connector 110. In some embodiments separate adhesives may be used.
In use, as depicted in
The reinforcement 2101 as described above may serve to more evenly distribute the stresses applied to the top layer of a wound dressing when a fluidic connector adhered thereto is pulled away from the dressing. Rather than focusing areas of intense stress at localized peaks of adhesive, the reinforcement applies the pulling stress to a larger area of the top layer of the dressing. By distributing the pulling load over a larger area of the top layer, the risk of pin holing in the dressing after a small tug is greatly reduced.
In some other embodiments, the reinforcement may extend over the entire distal end of the applicator. The reinforcement may comprise a film layer or section of adhesive tape, for example a PU, PET, Nylon, or PVCI patch. In some embodiments the reinforcement may be rectangular, although it may be any other suitable shape. The reinforcement may be transparent. The reinforcement comprises an adhesive on the lower, wound-facing surface for use in sealing the reinforcement to the top surface of the top layer of the wound dressing and the top surface of the fluidic connector. In use, a fluidic connector, as described herein above, is adhered to the top layer of a wound dressing, which may be similar to the wound dressing 10 as described in International Patent Publication WO2013175306, which is hereby incorporated by reference in its entirety. The fluidic connector may be adhered to the top layer of the wound dressing over an orifice therein. The reinforcement may be adhered to the top surface of the fluidic connector and to the top surface of the top layer of the wound dressing. The reinforcement is sufficiently large so as to extend past the edges of the distal end of the fluidic connector to seal with the top layer of the wound dressing.
Turning now to
As shown in
In use, the compression plate presses the fluidic connector 110 to the top surface of the dressing 100 to thereby exert a compressive force on the adhesive bead 2201. The compressive force exerted by the compression plate 2220 causes the adhesive to flow perpendicularly to the axis of compression. As the adhesive flows outwardly, towards the edge of the compression plate 2220, the tapered outer edge 2222 prevents the adhesive from flowing past itself. In this manner, the tapered outer edge 2222 may act as a terminus for the flowing adhesive 2201 and thereby create a circular ring of adhesive. Thereafter the compression plate 2220 may cease to press the fluidic connector 2200 to the top surface of the dressing 100 and the adhesive may be cured. It will be appreciated that in some embodiments the adhesive may be cured, or begin to be cured before the compressive plate ceases to press the fluidic connector 110 to the top surface of the dressing 100.
The circular adhesive ring formed by the compression plate comprises a substantially uniform outer edge, and does not comprise localized peaks of adhesive. Therefore, when a fluidic connector or suction port adhered to a top surface of a wound dressing is pulled away from the dressing there are no localized peaks of adhesive to create areas of intense stress concentration, reducing the risk of pin holing in the dressing after a small tug.
Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.
Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof, including embodiments which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments herein, and may be defined by claims as presented herein or as presented in the future.
This application is a continuation of U.S. application Ser. No. 16/107,660, filed Aug. 21, 2018, now issued as U.S. Pat. No. 11,154,649, which is a continuation of U.S. application Ser. No. 14/715,527, filed May 18, 2015, now issued as U.S. Pat. No. 10,076,594, entitled FLUIDIC CONNECTOR FOR NEGATIVE PRESSURE WOUND THERAPY, the contents of which are hereby incorporated by reference in their entireties as if fully set forth herein.
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| Number | Date | Country | |
|---|---|---|---|
| 20220096727 A1 | Mar 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16107660 | Aug 2018 | US |
| Child | 17498332 | US | |
| Parent | 14715527 | May 2015 | US |
| Child | 16107660 | US |
