JP6808323B2 - Wound dressing sealant and its use - Google Patents

Description

The embodiments described herein are components, devices incorporating them, devices, kits, their use in wound care, and, for example, advanced wound management, in particular, but not exclusively, negative pressure wound therapy ( In TNP therapy), it relates to a method of treating a wound and a method of creating a major wound dressing for use in a wound dressing.

There are various types of wound dressings to support the healing process of a subject or animal in need of a healing process. These include various types of materials, such as gauze with overlapping drapes, which are generally provided in square or rectangular shape, in the form of assembled layers and in size or shape. Or foams, as well as their composites. Advanced wound management dressings address specific wound therapies with specially made coating components, and although not exclusively, TNP therapy dressings provide a means of transmitting negative pressure to the wound and negative pressure. It is provided as an independent component or as a composite dressing, incorporating a liquidtight drape that encloses.

As a first task, we use the existing selection of synthetic TNP dressings for specific wound and body topography, eg, the subject's leg beyond the available dressing dimensions. Proper covering for diabetic foot ulcers, where the length of the vein harvest wounds, or complex topography, makes the rectangular design inadequately fit to the exact body contours. I'm finding that I can't.

As a further challenge, we present that advanced wound treatment and in particular TNP therapy are therefore inapplicable to wounds that are probably most in need of this therapy, but rather rely on conventional wound care. I find that I have to.

Therefore, we define the need for improved dressings, more specifically, but not exclusively, synthetic TNP therapeutic dressings that show improved adaptability in wound care. There is.

International release WO2009 / 156709 U.S. Pat. No. 3,808,178 U.S. Pat. No. 3,646,155 U.S. Pat. No. 3,274,155 U.S. Pat. No. 4,714,739 U.S. Pat. No. 7,543,843 U.S. Pat. No. 5,397,848 U.S. Pat. No. 7,132,170 International release WO 2012/06979 No. International release WO 2012/06979 No. U.S. Pat. No. 5,153,231 US Application Publication US 2006/02170 No. 16 U.S. Pat. No. 3,928,629 U.S. Pat. No. 4,529,553 European Patent Application EP-0633830-A2 International application PCT / GB2012 / 000866 Publication of US application US2012 / 0116334 (US application No. 13 / 381,885) US Application Publication US 2011/0213287 (US Application No. 12 / 886,088) US Application Publication US 2011/0282309 (US Application No. 13 / 092,042) US Application Publication US2011 / 0028918 (US Application No. 12 / 744,277) Publication of US application US2011 / 0054421 (US application 12 / 744,218) International release WO 2011/000622 International release WO 2011/000621 International release WO2011 / 135285 International release WO2011 / 135286 U.S. Pat. No. 7,964,766 U.S. Pat. No. 7,615,036 US Provisional Patent Application No. 61 / 800,040 UK Patent Application GB102000 5.3 UK Patent Application GB1019997.4 UK Patent Application GB1104512.7 International application PCT / GB2011 / 000629 International release WO 00/74738 US Application Publication No. 2012/308780 International release WO2013 / 076450

B. G. Willoughby and K. W. Scott, Understanding cure with the scanning vibrating needle curemeter (scanning VNC), RTL / 2844, Rapra Technology Limited, Shawbury L. M. Lopez, A. B. Cosgrove, J. P. Hernandez-Ortiz, T. A. Osswald, Modeling the Vulcanization Reaction of Silicone Rubber, Polym. Eng. Sci., 2007, 47, 675-683 British Pharmacopoeia (BP), 1993, 14th Edition, A222, Annex XX Walter Noll, "Chemistry and Technology of Silicones", Academic Press, 1968, 2nd edition, on pages 1 to 9 http://www.chloraprep.co.uk http://www.medmix.ch/L-SYSTEM.html Y. Walid, Z. Al-Ani and R. Gray, Silicone impression materials and latex gloves. Is interaction fact or fallacy ?, Dent Update, 2012, 39, pp. 39-42 http://snakeclamp.com/ http://joby.com/gorillapod

The purpose of a particular embodiment is to at least alleviate the above problems. Specific embodiments disclosed herein relate to improved constructs, and their use in combination with dressings, which provide improved adaptability in wound care, preferably in TNP wound care. A dressing applied in combination with such a construct may be more difficult to apply around a wound, especially a long incision site or an irregularly shaped wound, a conventionally applied dressing. Can have advantages over. The dressing applied to such wounds using such constructs can be as effective as the dressings applied in the conventional way for wounds of more regular size or shape. Combining such a dressing with such a composition to coat the wound may allow the application of TNP therapy. Also disclosed are improved methods and systems for use of the constructs in combination with dressings, preferably in negative pressure wound therapy.

An object of a particular embodiment is to provide a means for making synthetic wound dressings more universally available for wounds of various shapes or sizes.

An object of a particular embodiment is to provide a distributable sealant construct for synthetic wound dressings that can be used more universally for wounds of various shapes or sizes.

An object of a particular embodiment includes such constructs for distribution to a synthetic wound dressing in an improved manner for more universal use for wounds of various sizes or shapes. To provide a device.

An object of a particular embodiment includes a synthetic dressing, preferably an advanced wound management dressing, more preferably a synthetic TNP therapeutic dressing, together with a sealant construct, adapted to be applied to the wound site. To provide a wound dressing kit.

An object of a particular embodiment is to provide a device in the form of a synthetic wound dressing that can be used more universally for wounds of various shapes and sizes.

An object of a particular embodiment is to provide a method of treating a wound by sealing a synthetic dressing that can be used more universally for wounds of various shapes or sizes.

In one embodiment, a distributable component for wound care is provided, the component is distributed to the wound dressing location, and the wound dressing is
A backing layer with an upper surface and a lower surface, also called a backing sheet with two surfaces, which defines an outer circumference configured to be positioned on the skin surrounding the wound site. Reliance layer and
Optional wound contact layer,
Provided directly or indirectly to the underside surface of the backing layer, configured to be positioned under the backing layer, located on one side of one side of the backing sheet, or wound contact With one or more transmission layers that are encapsulated between the backing layer and the wound contact layer if the layers are present.
With a port configured to transmit negative pressure through the backing layer to apply local negative pressure to the wound site
By removing a portion of the wound dressing in which the transmission layer is directly encapsulated, a major wound dressing with one or more exposed portions where a portion of the transmission layer is exposed is created.
The one or more exposed parts are the positions defined above and the distributed components seal the one or more exposed parts.

Wound care, in particular, having a major dressing or cell that communicates with a fluid (eg, gas) with a further dressing or cell that is used for wound care, more specifically for the treatment of the wound site. It is intended to create a major wound dressing that seals a more specifically trimmable dressing used in.

The components may be distributed within, above, or both of the exposed portions. This means that the distributed constituents impregnate and / or surround the exposed portion.

Preferably, the dispensed construct impregnates the exposed portion. This has the advantage of improved robustness, which allows the seal to form part of the dressing.

Alternatively, the distributed construct surrounds the exposed portion. This is more similar to a simple repair applied to the upper surface of the dressing. The choice of distribution by impregnation or encapsulation may be selected according to the nature of the dressing to be sealed, in particular its layered structure, more specifically the layered structure of its exposed portion. Optionally, the construct surrounds in addition to impregnating the seal portion, thereby providing a seal that functions on the inner surface of the transmission layer and the outer surface of the dressing. The composition may be distributed directly through the exposed surface of the exposed portion, or indirectly via a backing layer or backing sheet, or through any wound contact layer, thereby exposing. It may penetrate inside the portion.

Some embodiments may further include a device comprising a component, a device in the form of a dressing used with the component, a kit thereof, a therapeutic use and method. Some embodiments may further include a negative pressure source configured to provide negative pressure through the port. Some embodiments may further include retention strips or seal strips that are configured to hold the dressing in place or to seal the dressing to the skin surrounding the wound.

In another embodiment, the method of making a dressing on the wound or creating a major wound dressing used to treat the wound in another way
The backing layer, also called the backing sheet,
Optional wound contact layer,
A step of providing a wound dressing as defined above, comprising one or more transmission layers as defined above.
A step of removing a portion of the wound dressing to create a major wound dressing with one or more exposed areas.
Optionally, a step of positioning the primary wound dressing over the wound and sealing the primary wound dressing against the skin surrounding the wound,
A step of distributing a construct as defined above to a location that includes one or more exposed areas of the main wound dressing, thereby sealing the exposed areas.
Optionally, it comprises applying negative pressure to the wound through the backing layer of the main wound dressing.

The wound dressing seal on the skin may be before the main wound dressing is made and before the constituents are distributed, or after the main wound dressing is made and before the constituents are distributed, or It may be after that. Thus, the method may be a method relating to the manufacture of a dressing used to coat the wound, or a method relating to covering the wound. As used herein, the backing layer represents a gas impermeable membrane. Also referred to herein as a wound cover or drape. Some examples of suitable materials for the backing layer included a thin polyurethane film, which may optionally be coated with an adhesive. It is also possible to combine a large number of laminates to form a multi-layered backing layer, in which example the description of the upper and lower surfaces of the backing layer will be described above and below the complete backing layer. Interpreted to mean the side surface.

As used herein, the dressing also comprises one or more transmission layers and other layers (such as absorbent materials) that are located below the backing layer. For example, one or more transmission layers or other layers may be positioned or encapsulated between the backing layer and any wound contact layer, eg, sealed between them. The one or more transmission layers may then be positioned between the backing layer and the wound site (optionally with the wound contact layer) on which the dressing is configured to be located, eg, those. It may be sealed in between.

Transmission layers, such as those described herein, allow fluids such as air and optionally other gases and liquids to move away from the wound site into one or more upper layers of the wound dressing and into the port. Also, if there is a fluid vessel from there, and / or allow transmission into the negative pressure pump. The transmission layer may help maintain the open air channel in communication with negative pressure over the entire wound area, even when the dressing is dealing with a significant amount of exudate. The layer should remain open under the general pressure that would be applied during negative pressure wound therapy. Preferably, the transmission layer remains open over the entire area corresponding to the wound site, thereby ensuring that the negative pressure across the wound site is equalized. Alternatively, the transmission layer may include one or more specific air pathways that remain open, such as within and between the crosslinked portions of the wound dressing, as described in more detail below.

The transfer layer may include gaps, or may contain one or more materials that transmit the fluid, or may be a combination thereof. The transfer layer may incorporate other functional materials, provided that it can still transmit negative pressure, and preferably liquid fluid. In some embodiments, the transmission layer is capable of transmitting wound exudates and other compositions.

Some examples of suitable materials for the transfer layer include three-dimensional structures such as knitted or woven spacer fabrics (eg Baltex 7970 weft polyester), but foams (eg reticulated foams), non-retainable. Of course, other materials can be used, such as woven materials (eg, acquisition partitioning layers as described below). Alternatively, or in addition, the transmission layer may incorporate an absorbent material to absorb the liquid under applied negative pressure and pull it away from the wound.

Some embodiments described herein include a trimmable coating material having an additional coating portion or cell and a major coating portion or cell communicating with a fluid (eg, gas). As used herein, the primary dressing refers to a portion having a size or shape or profile or joint that is compatible with the wound or wound site to which the dressing is applied. Even if one or more additional parts or cells are removed to provide a dressing with a size or shape or profile or joint that will be compatible with the wound or wound site to which the dressing is applied Good. Preferably, a large surface area or elongated main covering is provided to cover a similarly large surface or elongated wound, but for example a portion or cell is such a large surface or elongated main covering. It may be retained to provide a covering area, or the part or cell may be removed to cover a wound with a correspondingly reduced surface area or reduced length. Preferably, a main covering is provided that is shaped to cover a wound of similar shape, or incorporates or adjacent a protrusion of a device or the like (eg, a pin) or a body part (such as a finger). , A shaped main part is provided for covering the wound, eg, one or more additional parts or cells may be adapted to provide a shaped covering, preferably. To coat a wound or wound site of similar contour, such as a wound located on a complex body topography, a contoured main covering is provided, eg, one or more additional parts or The cell may be adapted to provide a contoured covering material, preferably articulated to provide a covering material to a similarly articulated wound or wound site, such as a wound located at a joint. A main covering portion is provided, for example one or more additional portions or cells may be concatenated.

One or more major covering portions and additional portions or cells as described herein are one or more bridge moieties including one or more transmission layers as described above, in other words a backing layer. It may be connected by a cross-linked portion underneath or otherwise located on one side of one side of the backing sheet, the cross-linked portion configured to transmit negative pressure from the first portion through the cross-linked portion. It comprises at least one material layer to be made. In some embodiments, at least one material layer of the crosslinked portion has a dimension smaller than or different from the corresponding dimension of the first portion, or has a material structure different from that of the material structure, eg, one. Alternatively, one or more transmission layers with the plurality of cross-linked portions have a width narrower than the adjacent portion of the one or more transmission layers or the main covering portion, or one or more cross-linked portions. One or more transmission layers comprising have a lower height than adjacent portions of one or more transmission layers or below the main covering portion.

As used herein, the exposed portion of the transmission layer is not configured such that the backing layer contacts a surface such as a wound site to enclose and seal it, eg, the backing layer and any wound contact layer transmit. Represents a portion that does not enclose the layer. For example, there is no compartment for the transmission layer and the backing layer above it, thereby terminating the remaining transmission layer in an open-ended manner, or the backing layer may be partially absent. In addition, any wound contact layer may be partially absent, where the transmission layer terminates in an open-ended manner. It may be desirable to seal such exposed areas of the transfer layer (and exposed areas of other layers). As used herein, a seal represents a seal in a fluid-containing form, more preferably a negative pressure-containing form.

As used herein, fluids represent liquids and gases. However, "fluid" is not intended to include "vapor" and a suitable water vapor transmission (MVTR) is a dressing requirement conceived herein. The backing layer is impervious or substantially impermeable to fluids, including wound exudates. The backing layer may be airtight or substantially airtight, thereby maintaining negative pressure at the wound site to which the dressing is applied and sealed with the construct. Wound exudates and other fluids may be contained within the wound site and / or dressing and any collection means associated with them.

As used herein, a distributable component represents a component having a viscosity in the range of 5 to 300 Pa.s, preferably 10 to 100 Pa.s. Viscosity (η) is determined according to DIN EN ISO 3219: 1994, Annex B. For some embodiments, the viscosity is in the range of 20-80 Pa.s. The components may be combined and allowed to partially cure to a viscosity suitable for application, or properties such that an appropriate reduction in viscosity is achieved when subjected to shear forces during application. You may have. The composition may have fluidity such that it can be stretched within one or more transmission layers in one or more exposed areas by predominant negative pressure and subsequent curing. The construct flows, for example, at a distance of 25 mm or less, for example 1 mm to 25 mm. The cured sealant preferably retains some flow or compatibility, such as extensibility, so that it can adapt to the dynamic conditions encountered when it is on the skin.

As used herein, the TNP system is operated with any suitable negative pressure source, including but not limited to pumps, springs (SNaP), and any other functional equivalents. May be good.

As used herein, the wound dressing represents a synthetic wound dressing, preferably in particular wound exudate management (eg ALLEVYN Gentle Border, DURAFIBER, ALLEVYN Life), infection management (eg ACTICOAT, IODOSORB). ), Intravenous site care (eg IV3000), management of damaged skin around the wound, TNP (eg RENASYS F / AB, PICO, KCI Prevena, Kalypto Medical Inc NPD1000 NP Wound Therapy System), surgical drapes, etc. Advanced wound management dressings that are tailored to include specific wound healing measures, most preferably for TNP dressings, such as post-operative care (OPSITE), temporary bio-skin dressings (eg BIOBRANE). Represent.

It is a figure which shows one Embodiment of a wound treatment system. It is a figure which shows that one embodiment of a wound treatment system is used and applied on a patient. It is a figure which shows that one embodiment of a wound treatment system is used and applied on a patient. It is a figure which shows that one embodiment of a wound treatment system is used and applied on a patient. It is a figure which shows that one embodiment of a wound treatment system is used and applied on a patient. It is sectional drawing which shows one Embodiment of a wound dressing. It is sectional drawing which shows another embodiment of a wound dressing. It is sectional drawing which shows another embodiment of a wound dressing. It is an exploded view which shows one Embodiment of a wound dressing. It is sectional drawing which shows one Embodiment of a wound dressing. It is an exploded view which shows one Embodiment of a wound dressing. It is sectional drawing which shows one Embodiment of a wound dressing. A commercially available wound dressing that can be trimmed to seal, size, contour on complex tomography, or shape around a fixed device or repair a puncture to seal with the components of the invention. It is a figure which shows the embodiment of a material. A commercially available wound dressing that can be trimmed to seal, size, contour on complex tomography, or shape around a fixed device or repair a puncture to seal with the components of the invention. It is a figure which shows the embodiment of a material. A commercially available wound dressing that can be trimmed to seal, size, contour on complex tomography, or shape around a fixed device or repair a puncture to seal with the components of the invention. It is a figure which shows the embodiment of a material. A commercially available wound dressing that can be trimmed to seal, size, contour on complex tomography, or shape around a fixed device or repair a puncture to seal with the components of the invention. It is a figure which shows the embodiment of a material. It is a figure which shows the use and application and seal of the embodiment of FIGS. A1 to A4 on a patient. It is a figure which shows the use and application and seal of the embodiment of FIGS. A1 to A4 on a patient. A commercially available wound dressing that can be trimmed to seal, size, contour on complex tomography, or shape around a fixed device or repair a puncture to seal with the components of the invention. It is a figure which shows the embodiment of a material. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming coating material. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming coating material. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming dressing, and is also the figure which shows the seal of the embodiment of a wound dressing. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming dressing, and is also the figure which shows the seal of the embodiment of a wound dressing. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming dressing, and is also the figure which shows the seal of the embodiment of a wound dressing. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming coating material. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming coating material. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming coating material, and is also the figure which shows the novel nozzle head for an applicator. It is a figure which shows the relationship of the spacer nozzle of the applicator for component distribution with respect to the trimming coating material. It is a figure which shows one Embodiment of the wound dressing which can be trimmed at the bridge part. It is a figure which shows another embodiment of the wound dressing which can be trimmed at a bridge part. FIG. 5 shows the use and application and seal of embodiments of FIGS. 5A-5B onto a patient. FIG. 5 shows the use and application and seal of embodiments of FIGS. 5A-5B onto a patient. It is a figure which shows one Embodiment of the trimming wound dressing which includes a plurality of parts or cells. It is a figure which shows the use and application and seal of one Embodiment of FIG. 6 on a patient. FIG. 5 shows an embodiment of a trimmable T-shaped wound dressing comprising a plurality of portions having a plurality of port attachment sites. It is a figure which shows the use and application and seal of one Embodiment of FIG. 7 on a patient. It is a figure which shows one Embodiment of the trimming wound dressing which has a plurality of port attachment sites. It is a figure which shows the use and application and seal of one Embodiment of FIG. 8 on a patient. It is a figure which shows one Embodiment of a spacer layer material. It is a figure which shows one Embodiment of a spacer layer material. It is a figure which shows one Embodiment of the acquisition distribution layer material. It is a figure which shows one Embodiment of the acquisition distribution layer material. It is a figure which shows one Embodiment of the acquisition distribution layer material. It is a figure which shows one Embodiment of the acquisition distribution layer material. It is a figure which shows one Embodiment of the absorbent layer material. It is a figure which shows one Embodiment of the absorbent layer material. It is a figure which shows one Embodiment of the shielding layer material. It is a figure which shows one Embodiment of the shielding layer material. It is a figure which shows one Embodiment of the adhesive spread on the cover layer material. It is a figure which shows one Embodiment of the trimming possible covering material which has a crosslinked portion with reduced height. It is a figure which shows one Embodiment of the trimming possible covering material which has a crosslinked portion with reduced height. It is a figure which shows one Embodiment of the trimming wound dressing which includes a plurality of parts or cells. It is a figure which shows another embodiment of the acquisition partition layer material. It is a figure which shows another embodiment of the acquisition partition layer material. It is a figure which shows another embodiment of the acquisition partition layer material. It is a figure which shows another embodiment of the acquisition partition layer material. It is a figure which shows another embodiment of the acquisition partition layer material.

The embodiments disclosed herein relate to components, devices, devices, uses, kits, and methods of treating wounds with decompression, including pumps and wound dressing components and devices. If there are devices and components that include wound overlays and packing materials, they may be collectively referred to herein as dressings, unless otherwise indicated or implied. Throughout this specification, the terms sealant and composition are used interchangeably below unless otherwise indicated or implied.

It is understood to refer to wounds throughout this specification. The term wound is broadly interpreted, with open and closed wounds with lacerations, cuts, or punctures on the skin, or open and closed wounds where trauma causes contusion, or any other wound on the patient's skin. It should be understood to include those that benefit from superficial or other conditions or imperfections, or other decompression treatments. Thus, a wound is broadly defined as any area of injury in tissue that may or may not produce fluid. Examples of such wounds are abdominal wounds or other large or open wounds caused by surgery, trauma, thoracic incision, myocardial incision, or other conditions, dehiscence wounds, acute wounds, chronic wounds, subacute and fissures. Open wounds, traumatic wounds, flaps and skin grafts, lacerations, scratches, contusions, burns, diabetic ulcers, decubitus ulcers, stoma, surgical wounds, cosmetic wounds, trauma, and venous ulcers. However, it is not limited to them. Wounds are easily accessible and difficult to access, exposed and hidden wounds, large and small wounds, regular and irregularly shaped wounds, flat wounds and topographically. Irregular, uneven or complex wounds, more preferably the torso, limbs and ends (heel, sacral, shaft, inguinal, shoulder, neck, leg, foot, finger, knee, axillary, arm and forearm, It may include those that are on a site selected from (elbow, hand, etc.), or those that seal a fissure adjacent to or in close proximity to the wound site, selected from sacral space, fossa, etc.

The embodiments of the present disclosure are generally applicable for use in local negative pressure (“TNP”) therapy systems. TNP therapy is sometimes referred to as vacuum assisted closure VAC®, or negative pressure wound therapy (NPWT) using quasi-atmospheric pressure includes chronic wounds, open wounds, open wounds, and abdominal wounds. It can be applied to a wide range of wounds.

Simply put, TNP assists in the closure and healing of many forms of wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, and removing excess exudates, and bacterial loading ( And as a result, the risk of infection) can be reduced. In addition, treatment can reduce wound disturbance and lead to faster healing. The TNP treatment system may also assist in healing surgically sutured wounds by removing fluid and helping to stabilize the tissue in line with closure. It can be found that TNP therapy is used more beneficially in grafts and flaps where it is important to remove excess fluid and the grafts need to be brought into close contact with the tissue to ensure tissue viability. ..

During TNP therapy, a suction source such as a vacuum pump is used to create a negative pressure area. That is, it is a region where the experienced pressure is lower than the ambient pressure. The suction source is located above the perimeter of the wound and creates negative pressure through a dressing or drape that is sealed around or around it. Wound exudates and other potentially harmful substances are encapsulated under and extracted from the dressing or drape.

As used herein, a reduced or negative pressure level such as -XmmHg represents a pressure level below standard atmospheric pressure equivalent to 760 mmHg (or 1 atm, 29.93 Hg, 101.325 kPa, 14.696 psi, etc.). Therefore, the negative pressure value of -XmmHg reflects the absolute pressure of XmmHg less than 760mmHg, in other words the absolute pressure of (760-X) mmHg. In addition, negative pressures "lower" or "less than" XmmHg correspond to pressures closer to atmospheric pressure (eg, -40mmHg is lower than -60mmHg). Negative pressure "higher" or "greater than" XmmHg corresponds to pressure farther from atmospheric pressure (for example, -80mmHg is higher than -60mmHg).

The negative pressure range for some embodiments of the present disclosure can be about -80 mmHg, or about -20 mmHg to -200 mmHg. Note that these pressures are relative to standard ambient pressure. Therefore, -200mmHg would be about 560mmHg in real terms. In some embodiments, the pressure range can be from about -40 mmHg to -150 mmHg. Alternatively, pressure ranges below -75 mmHg, below -80 mmHg, or above -80 mmHg can be used. Also, in other embodiments, pressure ranges less than -75 mmHg can be used. Alternatively, a pressure range in excess of about -100 mmHg, or even 150 mmHg, can be supplied by a negative pressure device. In some embodiments of the wound closure devices described herein, increased wound contraction may be associated with increased tissue extension in the tissue surrounding the wound. This effect is added to the wound over time by varying the force applied to the tissue, eg, increasing the tensile force applied to the wound through embodiments of the wound closure device. It can be increased by varying the negative pressure applied. In some embodiments, the negative pressure fluctuates over time using, for example, sine waves, square waves, and / or synchronization with one or more patient physiological indicators (eg, heartbeat). You may let me. NPWTs without a canister (omitting a dedicated canister to house the wound exudate) have also been considered to use negative pressure values within the same range as conventional NPWTs. More preferably, it is -40 to -200 mmHg. More preferably, it is -40 to -140 mmHg.

The embodiment provides a dressing in a range of sizes and shapes suitable for irregularly shaped wounds and body topography, which is impractical for both manufacturers and users, such as veins adapted to individual height and leg length variability. Address the challenge of providing post-harvest wound dressings. The embodiments improve the adaptability of existing dressings and the adaptability of more recently introduced multisite dressings such as trilobes and four lobes. In some embodiments, it is possible to remove a portion of the dressing to create a major wound dressing that seals the desired size or shape or profile or joint, as well as one or more exposed parts thereof, to contain negative pressure. become.

One or more exposed areas as defined above are the result of removing a portion of the wound dressing, which is due to any conceivable means, such as cutting or tearing the wound dressing along the line of weakening. It may be a thing. The synthetic wound dressing may provide a boundary for anchoring around the wound, centered on the central wound contact area. A dressing as defined above has a footprint or surface area similar to that of the intervening transfer layer or other layer (ie, a rimless dressing), or a foot larger than the intercalated transfer layer. It may include a print or surface area (ie, rimmed dressing), a backing layer and a wound contact layer. One or more exposed areas as defined above, wherein the transmission layer is directly encapsulated, for example, by cutting into or cutting through the backing layer and the wound contact layer and the transmission layer between them. Obtained by removing a portion of the wound dressing as defined.

One or more parts of the wound dressing are sized so that they are positioned on top of the wound as defined above, such as an incision wound, an elongated leg wound, an arched incision wound, etc. May be removed. Similarly, one or more parts of the wound dressing may be located on a wound as defined above, such as a flap wound, or on a protruding device, such as a fixation device or a protruding body part, so that the primary wound dressing is located. Flexion, for example, to shape a portion, on a wound as defined above, for example to outline a major wound portion, as positioned on a complex body topography, or on a wound as defined above. It may be removed to join the main wound dressing over the joint.

Preferably, the dressing is skin compatible. Skin compatibility, as used herein, refers to a dressing and particularly a backing layer or a wound contact layer without trauma to the wearer and without substantial damage to the skin. It refers to being able to be applied or reapplied to the skin and removed from the skin. Skin-compatible materials include pressure-sensitive adhesives (PSA), generally acrylic, hydrocolloid, silicone, and silicone-based materials, as well as other adhesive or non-adhesive materials such as those listed below. Can be mentioned. Particularly well-known skin-compatible materials are silicone-containing or silicone-based, and it is conceivable that the skin-compatible material has properties equivalent to silicone or silicone-based materials.

Components and Methods for Distributing The components may be selected from cured and non-cured systems. Ideally, this is a material that does not substantially flow from its application site, but is shear thinned or shape compatible when loaded during application. The curing system may be selected from curable one-component or multi-component components such as silicone curing systems, and the silicone curing system may include one-part, two-part, or multi-part silicone systems, and may vary. Curing mechanism, epoxy curing system, cyanoacrylate curing system, polyurethane curing system, polymer system functionalized with silicone cross-linking functional group, polymer system functionalized with polyurethane curing functional group, elastomeric due to the presence of volatile solvent It may include a dry system such as a liquid, a spray polymer such as acrylic in a water or solvent base, a UV or a photocurable system.

The uncured system is selected from one-component or multi-component components such as jelly such as putty and petroleum jelly, grease such as silicone grease, gel such as hydrogel, organogel such as xerogel, paste, colloidal system such as hydrocolloid. May be good.

Preferably, the constructs distributed in positions as defined above form an elastomeric seal.

The curing time of the curable component is not a limitation. The cured composition is usefully at 23 ° C. for 0.05 minutes to 24 hours, for example 0.5 to 20 minutes, more preferably 0.5 to 18 minutes, more preferably 0.5 to 16 minutes, most preferably 12 minutes, most preferably 0.5. It has a curing time in the range of ~ 5 minutes. Curing time is manual kinetic, as is known in the art.

Numerous methods of monitoring the curing of liquid polymers, and especially RTV-2 silicones, are known in the art and these are BG Willoughby and KW Scott, Understanding cure with the scanning vibrating needle. curemeter (scanning VNC), RTL / 2844, Rapra Technology Limited, Shawbury), or differential scanning calorimetry (LM Lopez, AB Cosgrove, JP Hernandez-Ortiz, TA Osswald, Modeling the Vulcanization Reaction of Silicone Rubber, Polym. Eng. Sci From those that continuously monitor the entire complete curing profile of a material using equipment such as., 2007, 47, 675-683), for example, recording the time it takes to reach the gelation point, generally Can range from empirically determining a single point based on clear physical changes.

During the trials described in the examples, it was found that the transfer of uncured sealant from the application site to other surfaces was a clear disadvantage. For the purpose of defining a clear single point in the cure profile, cure time is understood to mean finger motility cure time. The finger motility cure time is defined herein as the cure time (at a specified temperature) where the material does not move to the skin (ie, fingertips) when touched lightly and briefly.

Since the cure profile is temperature dependent on the additional cured RTV silicone, it is important to perform comparisons of both measurements at the same temperature and report that temperature. In the guidance presented for surgical dressing test methods in the British Pharmacopoeia (BP), 1993, 14th Edition, A222, Annex XX, the temperature of the conditioned atmosphere is understood as 20 ° C ± 2 ° C. .. In the silicone industry, there are many cases where additional curing RTV-2 silicone curing parameters have been reported at a nominal temperature of 23 ° C, which is the viscosity (when measuring viscosity, DIN EN ISO 3219: 1994 , The preferred measurement temperature is described as 23.0 ° C ± 0.2 ° C), which is consistent with standard test methods for other temperature-dependent properties. Examples of this include: Potency reported by Wacker Silicones (at 23 ° C, Wacker Chemie AG, Munchen's Silpuran® 2455 A / B, version 1.3 technical datasheet and Silpuran® 2450 A / B, version 1.3 According to the technical data sheet of. Maximum operating time reported by Bluestar Silicones (at 23 ° C, according to Bluestar Silicones France SAS, Lyon's Silbione® Difference, Silicones for Healthcare Applications), and Momentive Performance Materials Inc. ., defined in Columbus Silicone Gels for Healthcare Applications, 152-053-00E-GL as the time it takes for the initial viscosity to double at 23 ° C). It should be noted that when considering the temperature of the material applied to the skin, the temperature of the skin is usually understood to be 32 ° C. In the clinical environment, the cured RTV-2 silicone is applied as a thin bead, layer, or membrane that comes into close contact with the skin, and it is assumed that the material quickly reaches thermal equilibrium with the skin.

In the literature, other discrete points along the treatment profile are customarily used, and noteworthy is the pot life. This usually indicates the maximum period during which mixed silicone processing, injection, diffusion, etc. can still be performed. If flow is an important requirement, pot life is usually the time it takes for the initial viscosity to double (Elastosil, RTV-2 silicone rubber 6020e / 06.06 treatment, Wacker Chemie AG, MQnchen), and half. Quoted as cure time, this is a good indicator when considering rubber (by definition, the material should not have any identifiable adhesion or adhesion once cured), in a manner similar to finger mobility. It may be evaluated.

Preferably, the composition, as defined above, is at 23 ° C. for 0.5-20 minutes, more preferably 0.5-18 minutes, more preferably 0.5-16 minutes, most preferably 12 minutes, most preferably 0.5-. It has a curing time in the range of 5 minutes. Curing time is finger motility as defined above.

Values at 32 ° C are particularly beneficial in this application, preferably curing times at 32 ° C are in the range of 0.5-10 minutes, more preferably 0.5-8 minutes, most preferably 0.5-7 minutes. ..

Adhesion Below, adhesion is measured as the maximum force required to separate the probe from the cured construct. However, for the purpose of determining semi-curing or low-adhesion time, controlled samples are subjected to finger-spaced touch and lift tests to achieve semi-curing or low-adhesion time. It was determined as the time during which the sample did not adhere and did not lift due to contact.

Preferably, the semi-curing time is in the range of 0.5-25 minutes, more preferably 0.5-22 minutes. Preferably, the composition has adhesion as defined above for a period of 0.5 to 22 minutes after binding, such as not adhering to items such as paper or clothing that come into contact with the composition. Finger stickiness is a relatively subjective assessment that can be obtained by touching the surface of the distributed constituents and determining their "adhesion". Descriptive terms such as high (H), low (L), and medium (M) can then be attributed as preliminary indicators.

Preferably, the construct intended for the outer seal of the exposed portion forms a substantially semi-cured seal for a period as defined above. Preferably, the construct intended for internal sealing within the crosslinked portion forms a substantially semi-cured to moderately adhesive seal.

Viscosity Preferably, as defined above, constructs with low viscosities in the range 11-14 Pa.s ^-1 are particularly advantageous when first dispensed.

The construct may be shear thinning, which exhibits a change in viscosity at, for example, the following shear rates to aid application.
Target Shear Rate (s ^-1 ) Viscosity (Example Range) mPa.s ^-1
1.0 250 (240-270)
2.50 80 (65-94)
5.00 55 (42-63)
10.00 40 (33-51)
25.00 20 (20-25)
50.00 15 (9-21)
100.00 10 (5-13)

The shear thinning constructs advantageously return to their resting viscosity and remain in place once the distribution or applicator forces have been removed.

Alternatively, the rapid initiation of curing stabilizes the composition in place. Preferably, the composition penetrates into the transfer layer and any additional layer up to a distance of 1 mm to 10 mm, eg, substantially 5 mm. Penetration should not exceed 25 mm.

Stretchability A dressing as defined above should be as close as possible to the skin, minimizing discomfort and maximizing its beneficial effects. WO2009 / 156709 discloses skin properties that should be approximated by dressings, especially those related to extensibility. Preferably, the composition cures to a seal, which approximates the extensibility of the dressing to be sealed and / or the extensibility of the wearer's skin. Preferably, the cured composition as a sample with a height of 1 mm is applied to the main coating, cross-linked parts, one or more trimmed parts, or their component layers below the maximum value corresponding to the backing sheet. Has comparable or higher extensibility. For example, in the case of a backing sheet, the load required to produce 20% elongation at an elongation rate of 300 mm / min is in the range of 1.4 kgf / cm width (kgfcm ^-1 ) or less, preferably 0.001 to 1.4 kgfcm ^-1 . range, preferably in the range of 0.001～14.0Kgfcm ^-2, more preferably 0.001～5.0Kfgcm ^-2 to cause elongation of 20%.

The extensibility of a typical spacer layer is approximately 0.08 kgfcm ^-1 (direction A) and 0.07 kgfcm ^-1 (direction B).

General superabsorbent layer (Laminate EU33 top film, Chemposite 11C / 450 airlaid superabsorbent pad, spacer layer Baltex 7970, and perforated silicone wound contact layer extensibility is approximately 0.59 kgfcm ^-1 (Direction A), 0.78 kgfcm ^-1 (Direction A).

Preferably, the extensibility of the seal as defined above is 0.04 to 3.00, more preferably 1.00 to 2.50.

Permanent strain The permanent strain of the cured seal encapsulated in the layer may be near zero. For seals encapsulated within the layer, the permanent strain is preferably in the range comparable to the Allevyn dressing.

In the case of a seal encapsulated in a tensile strength layer, the benefits of the composition obtained from the support of the dressing and the tensile strength value may be widely variable. For seals encapsulated in layers, the tensile strength is preferably in the range comparable to Allevyn dressings.

In the case of a seal encapsulated in a break elongation layer, the benefits of the composition obtained from the support of the dressing and the break elongation value may be widely variable. In the case of a seal encapsulated in a layer, the elongation at break is preferably in a range comparable to the spacer material commonly present in dressings. The breaking elongation of the spacer is 115%. Preferably, the elongation at break is in the range of 5-15%.

Compressibility Preferably, the composition forms a seal with a compressibility equal to or higher than the crosslinked layer. Further details are given herein with respect to the preferred compressibility of the crosslinked layer under negative pressure and the material of the crosslinked layer. Preferably, the seal does not project over the exposed portion of the seal, preferably the protruding seal is compressible. The compressibility is measured according to the penetrometry ASTM 82137, preferably in the range of 20-500 / 10 mm.

It will be clear that the viscosities of components A and B respectively are for the components as provided before mixing. Appropriately, the components are mixed to a distributable viscosity.

Preferably, the cured composition has a breaking elongation of 50% or more as defined below. Preferably, the cured composition has a tensile strength of 5 kgfcm ^-2 or greater, as defined below. Preferably, the permanent strain of the cured composition is in the range of 20% to 0%.

Preferably, the construct is a Silpuran construct as listed below, more preferably a Silpuran 2400, or a functional analog thereof, optionally resulting in an increase in viscosity and a decrease in cure time, viscosity and / or A curing time modifier is incorporated. Preferably, the composition has a translucent appearance after curing. Preferably, the constituents are distributed within the transmission layer by the method of the first embodiment disclosed herein (Fig. C1).

In the first embodiment, the constructs are distributed in positions as defined above, which positions are either substantially inside the transmission layer in the exposed portion as defined above, or are such. Accepted inside. In this embodiment, the construct needs to be dispensed from the outlet of a distribution device such as a static mixer, which outlet can be received within the transmission layer at an exposed portion as defined above. Suitably, the dispenser comprises a syringe or static mixer with a nozzle having an outlet. Preferably, the nozzle is located at a short distance within the exposed portion where the components are distributed, eg, a distance of 25 mm or less from the exposed portion, more preferably 2 mm to 20 mm, more preferably 3 mm to 18 mm, for example 5 mm to 12 mm. It can be accepted into the transmission layer in the exposed portion in such a way that it is in the range of. The composition may be distributed by injecting through the exposed partial surface or through the backing layer or sheet, for example through the backing layer or sheet. Distributing may be before or after trimming the dressing. Distributing by this means may be by puncturing the film in a single or multiple positions as described above. Preferably, the film is punctured using one or more elastically deformable needles, such as plastic needles, or using one or more needles with a limited penetration depth. Such needles minimize the risk of puncturing the skin. Alternatively, the injection can be performed prior to the placement of the dressing and the removal of the dressing handle, so that the sealant is constrained between the backing layer or sheet and the handle. Distributing may be before trimming the dressing to leave a sealed edge with or through the cured sealant. The construct may also be distributed to the intact skin and the exposed portion of the dressing located on it. The components so distributed flow into or are drawn into the dressing to reach the transmission layer, where sealing is performed.

The components so distributed are distributed deeper within the exposed portion at a distance from the surface. The construct is distributed as a band that returns to the surface of the exposed portion as the distribution device is withdrawn. The seal thus produced is more reliable and the passages within the exposed portion of the transmission layer are more comprehensively blocked. Such seals are less likely to show leaks when negative pressure is applied. Suitable nozzles for distribution devices include low aperture nozzles, needles and the like. The nozzle may be made of plastic. Such nozzles are disposable, do not pose a hazard, and do not pierce human skin. Such nozzles are currently available for use with pipette tips.

The constructs may be distributed by multipoint injection at intervals along the exposed surface, for example through the space between the spacer layer struts. The composition may flow laterally in one or both directions of distribution and forward and backward, to some extent in the first application, with less flow as the composition hardens or hardens. This may help provide a continuous lateral seal, which may increase the distribution interval along the surface of the exposed portion. The nozzle insertion distance within the exposed area can be such that the seal is confined in a short distance from the surface of the exposed area, or the composition can slightly overflow outside the exposed area and on the surrounding surface such as a slide or skin. May be selected as. The advantage of this embodiment is that the amount of constituents required for distribution is minimized. This then allows the use of lower volume dispensing devices, such as 5 ml or 10 ml or 15 ml or 25 ml syringes or static mixers. The back pressure faced during distribution from the static mixer increases with the volume of the mixer, which in turn leads to a decrease in viscosity that the static mixer can distribute. In general, it is advantageous for this embodiment to deliver the composition with the highest possible viscosity to ensure that the composition is confined within the exposed portion. An additional factor in the total back pressure or resistance faced during component distribution is the nozzle opening of the static mixer. In the case of this embodiment, it is desirable to distribute the construct from a nozzle with a small opening, which adds back pressure. The advantage of this embodiment, which allows the use of syringes or mixers of relatively small volumes, allows for greater freedom in operating nozzles with small openings.

Finally, the inventors have found that the seal produced by distributing the constructs inside the exposed portion according to this embodiment is very effective. As mentioned above, the dressing should be trimmed so that the exposed area overlaps the intact skin around the wound and not over the wound itself. For dressings that have an adhesive or sticky wound contact layer, such as the silicone contact layer as described above, the wound contact layer adheres to the skin around the wound and covers the exposed area and around the distributed seal. Seal the material to the skin. Preferably, the exposed portion has a depth of, for example, preferably 5 mm to 25 mm, more preferably 7 mm to 25 mm, such as 14 mm to 25 mm, depending on the boundary region at its two ends, as defined above. Or the boundaries are defined by the boundaries of the layers. The wound contact layer is perforated or otherwise porous to allow fluid transfer to and from the wound bed, thereby allowing the constituents to flow onto the skin in direct proximity to the internal seal. be able to. This can beneficially improve the seal between the wound contact layer and the skin. If it is not desirable to flush the composition against the skin in direct proximity to the inner seal, the composition is adequately viscous enough to limit the flow, or a wound contact layer is conceived. It may be non-porous or non-permeable in the region close to the exposed portion, eg, in the crosslinked or trimmable portion as defined above. The constituents may be distributed in positions as defined above in a dressing that does not have a shielding layer or has one or more windows in the shielding layer in a crosslinked portion or one or more trimmable portions. .. This allows visual control of nozzle insertion distance, amount to be distributed, and / or lateral flow within the exposed portion of the configuration to determine the appropriate distribution interval across the surface of the exposed portion. be able to. In the absence of a shielding layer, it is preferred that the construct incorporate the ADL as defined above as a transmission layer rather than a spacer layer, which may pose a risk of entry into the backing sheet.

In this embodiment, preferably the dressing does not contain an absorbent layer such as ADL in the crosslinked or trimmable portion.

In a further embodiment of the configuration for distribution to a position as defined above, the position comprises a backing layer or backing sheet adjacent to the exposed portion, whereby the configuration traverses the exposed portion. Flow and cover it. In some cases, the construct flows a short distance into the exposed area or is drawn in a short distance within the exposed area. It may be desirable to distribute or smooth the construct, eg, at the outer perimeter or end of the exposed portion close to the boundary region, for example, to slightly reverse along the perimeter or end. This has the advantage that the configuration is advanced a short distance on the outer periphery of the exposed portion to ensure an overall seal and to secure the seal in place. As the composition hardens or hardens, the viscosity generally increases and the flow ceases, thereby retaining the composition in or within the distribution position and forming an effective seal.

This further embodiment provides performance requirements for the components and the resulting seal, in addition to the performance requirements for the first embodiment of the seal and distribution mode. Specifically, the composition forms a continuous film distributed over the surface of the backing layer or sheet, crosslinks over the exposed portion of any additional layer and the exposed portion of the transmission layer, and on the skin surface. Needs to be crosslinked. Therefore, the composition must be sufficiently viscous and / or cohesive to form an intact film. Such films may be thin or suitable, from about the depth and / or thickness of the backing sheet to about the depth and / or thickness of the component layer in the dressing or its exposed portion, eg, 1 mm to 5 mm. Depth and / or thickness. If such a film breaks or breaks before the composition solidifies or cures, the seal will break. After solidification or curing of an intact film, the exposed nature of the seal and its ability to retain integrity across the interface between adjacent layers by being presented as a film. , Robustness requirements are added. These requirements tend to be greater for thin films. Preferably, therefore, the seal according to this further embodiment is characterized by tensile strength, permanent strain, and elongation at break, and optionally extensibility, to the extent defined above. In contrast, the seal produced by the first embodiment as described above is largely supported by the dressing fabric that encloses the seal, thereby satisfying the requirements for tensile strength, permanent strain, and elongation at break. Encapsulated in a coating material that is significantly lower and has lower extensibility, the extensibility requirement is significantly lower than in the further embodiments herein.

The seal according to this embodiment may be effective from the backing layer surface over the entire exposed portion. As will be apparent, the seal over the exposed portion alone is vulnerable to breakage at the interface between the backing sheet and the exposed portion and any intervening layer.

This further embodiment tends to be more effective when adapted in the context of a dressing that does not contain additional layers as defined above, thereby at the interface of one or more additional layers and transmission layers. Good resistance to the strain introduced by the separation in. If one or more additional layers are present, they may be beneficially fixed to each other and to the transmission layer at their interface by puncture, suturing, and other means as known in the art. Good.

A further embodiment further requires that the seal have a low profile and / or a compression ratio higher than or equal to that of the covering material surrounding it. This is an advantage in minimizing discomfort to the wearer due to the protruding ridges on the exposed portion of the dressing.

In one embodiment, the composition may include any polymer that follows a hydrosilylation reaction. One polymer (i) preferably contains an alkenyl group and the other (ii) preferably contains a Si—H moiety. The group of siloxane polymers is based on a structure containing alternating silicon and oxygen atoms with various organic moieties attached to the silicon. Curing can be defined as a process that reduces the flow of the elastomer. This change is generally caused by a binding reaction between polymer molecules. If the silicon hydride (Si-H) moiety is part of a polysiloxane, then the alkenyl group can be part of a siloxane polymer or part of a non-siloxane polymer. The position of the alkenyl functional group is not important and may be at the end of the molecular chain or at a position other than the end along the molecular chain.

The curing system is preferably one or more alkenyl group-containing polymers (i), one molecule, distributed between at least component A and at least component B and having at least one alkenyl group or alkenyl moiety per molecule. A catalyst (iii) for curing by adding one or more SiH-containing polymers (ii) and an alkenyl-containing polymer (i) to the SiH-containing polymer (ii), each having at least one Si-H unit. )including.

"Unit" as used herein refers to a group or part or part thereof. A "part", as referred to herein, is a group of atoms having two or more additional atoms arranged around it, i.e. having two or more unspecified valences.

As referred to herein, "group" refers to a group of atoms having an additional atom located on one side of it, i.e. having one unspecified valence. The Si-H unit in the present specification has the same meaning as the SiH unit.

Polymers (i) and (ii) as defined above are liquid phase polymers incorporating reactive groups that are crosslinked in the presence of a catalyst to form a copolymer, more preferably a cured elastomer. Suitably, component A comprises a catalyst with polymer (i) and component B optionally comprises polymer (ii) with the remaining polymer (i), if any. Appropriately, the polymer, catalyst, and any additional components are distributed in a manner that balances the volume and viscosity of both moieties. Preferably, the polymer (i) is an alkenylsiloxane-containing polymer.

Preferably, the moieties are combined and intimately mixed before or during distribution.

Appropriately, the components and moieties are mixed to give a distributable viscosity.

The polymers (i) and / or (ii) may be commercially available or obtained by known techniques. Suitably, polymers (i) and / or (ii) are selected independently of known novel homopolymerized and copolymerized polymers of the liquid phase, as well as their entangled systems and mixtures thereof. To. The constructs are then cured to form copolymers and may also contain confounding systems thereof and mixtures with other non-reactive polymers, if present in the constructs.

Copolymers are all derived from more than one monomer species, including alternating copolymers, periodic copolymers, statistical copolymers, random copolymers, block copolymers, linear copolymers, branched copolymers, star copolymers, graft copolymers, and pendant copolymers. Includes a mixture of. The confounding system includes an interpenetrating network (IPN) and a semi-interpenetrating network (SIPN). It is also true that these polymers can incorporate both organic and inorganic moieties.

Preferably, the polymers (i) and (ii) are silicones such as siloxane and modified siloxanes, polyurethanes (PUs) such as polyesters and polyether urethanes, and polyacetates such as elastomeric polyether polyesters, polyglycolic acids, ethyl vinyl acetates. , Polyacrylates, carboxyalkyl celluloses, carboxyalkyl chitosans, and polyacid derivatives of polysaccharides such as copolymers thereof, and mixtures such as copolymers, entanglements, and mixtures thereof.

The composition may utilize an additional curing reaction between the organohydrogensiloxane unit and the organoalkenylsiloxane unit. These units may be incorporated into a wide range of polymeric, copolymeric, confounding, and mixed polymers as defined above. Therefore, preferred siloxane polymers (i) and (ii) contain their respective units, more preferably polyorganosiloxanes. The polymer (i) is preferably a polydiorganosiloxane polymer containing an alkenyl-containing unit, and more preferably a polydiorganoalkenylsiloxane polymer. Preferably, the polymer (ii) is a polydiorganosiloxane polymer containing SiH units, more preferably a polydiorganohydrogensiloxane polymer.

Examples of organic-inorganic mixed polymer systems using both siloxanes and organic units have been found to be used in contact lenses, acrylate-functionalized siloxane copolymers (US 3,808,178), eg, organic polymers through siloxane bond formation. In silane graft technology for crossable HDPEs (US 3,646,155) where hybrid grafts are used to allow cross-linking, organic polymers are grafted onto polysiloxane chains, or siloxanes are placed on organic polymers. Hybrid grafts, hybrid block copolymers to be grafted, such as silicone polycarbonate block copolymers (US 3,274,155), and silicone and ethylene copolymers crosslinked with vinyl-containing silicone copolymers, which have been found to be used in textile coatings. Hybrid copolymers (US 2005/0100692).

IPN represents a particular classification of hybrid polymer systems, which use a combination of mechanical entanglement and cross-linking in which one polymer is cured around another. These are entangled with addition-curable silicones with platinum catalysts, such as silicone urethane IPNs and semi-IPNs, including silicone urethanes and silicone polyamides, which have been found for general use or specific applications in textile coatings. Polyamide resin (US 4,714,739, US 7,543,843), hydrophilic components immobilized in silicone polymers (US 5,397,848), which have been found to be used as contact lens materials, and applications in textile coatings. Included are silicone polymers (US 7,132,170) cured around a comparable adhesive non-reactive polymer for which has been found.

The polymer may also be selected from modified silicones (MS), which are found to be used as adhesives in catheter tubing and the like.

Preferred constructs include polydiorganosiloxane polymers (i) and / or (ii), and / or combinations of each of them with the polymers described above. Compositions in which the polymer comprises or consists essentially of polydiorganosiloxane polymers (i) and (ii) are, for example, in applications where low viscosity is an advantage, preferably in medical or dental applications, or in low toxicity or preferred biocompatibility. It has certain advantages in non-medical or non-dental applications that require compatibility.

Alternatively, or in addition, the polymers (i) and (ii) may be commercially available (such as Cavi-Care ™ AB) or variants thereof, as defined above, on liquid-tight exposed surfaces. Hereinafter, it is optimized for viscosity and hardening to give epidermis formation or "skinning").

Polymers (i) and (ii) contain alkenyl-containing units and organohydrogensiloxane units, respectively, placed along the length of the polymer chain and / or end cap units of the polymer chain, or a combination thereof. It may be included. The intrachain and end cap alkenyl units of the polymer (i) are preferably alkenyl groups or alkenyl, optionally substituted or selected from C _2-20 alkenyl containing one or more aryl groups or aryl moieties. Includes partial R ^Alk . The R ^Alk may contain terminal unsaturated or non-terminal unsaturated and may be of formula iI.
(iI) -R ^{Alk1 --CR Alk1} = CR ^Alk2 ₂
(Groups R ^Alk1 and R ^Alk2 are independently selected from H groups, C _1-20 alkyl groups, and C _5-20 aryl groups, and combinations thereof, and partial R ^Alk1 is a single bond, C _1-20. Selected from alkyl groups, C _5-20 aryl groups, and combinations thereof. One of the R ^Alks may be the moiety attached to the polymer chain. More preferably, each R ^Alk is a vinyl, allyl. , Propenyl-independently selected from terminal and non-terminal unsaturated butenyl groups, pentanyl groups, hexenyl groups, heptenyl groups, octenyl groups, nonenyl groups, and decenyl groups, most preferably vinyl and hexenyl groups. )

Preferably, the polymer (i) comprises a polydiorganosiloxane polymer or copolymer comprising an alkenyl-containing unit of formula (i-II).
(i-II) = Si-R ^Alk , more specifically of equations (i-III) and / or (i-IV).
(i-III) -O-Si R ¹ R ^Alk -O-
(i-IV) -O-Si R ¹ ₂ R ^Alk
(R ^Alk is as defined above, where one or more groups R ¹ are alkyl and aryl groups, more preferably C _1-20 alkyl groups and C _5-20 aryl groups and theirs. Organo groups appropriately independently selected from the combination, eg, methyl group, ethyl group, propyl group, butyl group, pentyl group, hexyl group, heptyl group, octyl group, nonyl group, and / or decyl group and moiety. Is)

More specifically, the polymer (i) is selected from the formulas iV and i-VI.
iV: P ⁱ -O-Si R ¹ R ^Alk -OP ⁱ
i-VI: P ⁱ -O-Si R ¹ ₂ R ^Alk
(P ⁱ refers to the rest of the polymer chain, which may incorporate the same or different units, R ¹ is as defined above)

The polymer (i) also exhibits at least two C _2- C ₆ alkenyl groups per molecule attached to silicon, eg, a polyorgano having a viscosity of 10-300 000 mPa.s, ie 0.01-300 Pa.s. It may contain a siloxane, whereby when combined with a component of additional component A in component A and optionally in addition to a component of additional component B in component B, component A and optionally component B , Viscous in the range as defined above, and in particular can be formed in at least two siloxyl units of the following equation:

(-Y is a C _{2 to} C ₆ alkenyl, preferably vinyl, such as a vinyl, allyl, or hexenyl group.
--R is an alkyl group having 1 to 8 carbon atoms including methyl, ethyl, propyl, etc., and a cycloalkyl group such as 3,3,3-trifluoropropyl group, cyclohexyl, cycloheptyl, and cyclooctyl groups, and A monovalent hydrocarbon group generally selected from aryl groups such as xylyl, trill, and phenyl, which does not have an unfavorable effect on the activity of the catalyst.
--d is 1 or 2, e is 0, 1, or 2, d + e = 1, 2, or 3)
Optionally, all other units are the units of the following averaging formula:

(R has the same meaning as above, f = 0, 1, 2, or 3)

Examples of polymer (i) include, for example, dimethylpolysiloxane containing a dimethylvinylsilyl end, a (methylvinyl) (dimethyl) polysiloxane copolymer containing a trimethylsilyl end, or (methylvinyl) (dimethyl) poly containing a dimethylvinylsilyl end. It is a siloxane copolymer.

An accepted practice in the art of representing a unit of silicone according to the number of oxygen atoms bonded to silicon is used herein. This convention uses the letters M, D, T, and Q (abbreviations for "mono," "di," "tri," and "quattro") to represent this number of oxygen atoms. This nomenclature for silicones is described, for example, in the study of Walter Noll, "Chemistry and Technology of Silicones", Academic Press, 1968, 2nd edition, on pages 1 to 9.

The polymer (i) may also be a silicone resin having at least two alkenyl groups, preferably vinyl groups. Comprising at least two different siloxane units, such silicone resin has the formula R ₃ SiO _1/2 of M siloxane units, D siloxane units of the formula R ₂ SiO _2/2, T siloxane units of the formula RSiO _3/2, and the formula Selected from the Qsiloxane units of SiO _4/2 , in the formula R represents a monovalent hydrocarbon group and, as a condition, at least one of these siloxane units is a T or Qsiloxane unit, M, D. And at least two of the Tsiloxane units contain alkenyl groups.

The silicone resin can be selected from the following groups.
Organopolysiloxane resin of formula MT ^Vi Q consisting essentially of:
(a) Trivalent siloxane unit T ^{Vi of} equation R'SiO _3/2 ,
(b) formula R ₃ of SiO _1/2 monovalent siloxane units M and,
(C) Tetravalent siloxane unit Q of Equation SiO4 / ₂
Organopolysiloxane resin of formula MD ^Vi Q consisting essentially of:
(a) Divalent siloxane unit D ^{Vi of} equation RR'SiO _2/2 ,
(b) formula R ₃ of SiO _1/2 monovalent siloxane units M and,
(C) _Tetravalent siloxane unit Q of Equation SiO _4/2
Organopolysiloxane resin of formula MDD ^Vi Q consisting essentially of:
(a) Divalent siloxane unit D ^{Vi of} equation RR'SiO _2/2 ,
(b) Formula divalent siloxane units D of R ₂ SiO _2/2,
(b) formula R ₃ of SiO _1/2 monovalent siloxane units M and,
(C) _Tetravalent siloxane unit Q of Equation SiO _4/2
Organopolysiloxane resin of formula M ^Vi Q consisting essentially of:
(a) Formula R'R ₂ SiO _1/2 monovalent siloxane units M ^Vi and,
(B) The tetravalent siloxane unit Q of Equation SiO _4/2 , and
Organopolysiloxane resin of formula M ^Vi T ^Vi Q, which consists essentially of:
(a) a compound of the formula R'R ₂ SiO _1/2 of monovalent siloxane units M ^Vi,
(b) Trivalent siloxane unit T ^{Vi of} Eq. R'SiO _3/2 , and
(C) _Tetravalent siloxane unit Q of Equation SiO _4/2
(R represents a monovalent hydrocarbon group such as methyl, and R'represents a vinyl group)

Such resins are well-known branched organopolysiloxane oligomers or polymers on the market. They are provided in the form of solutions, preferably in the form of siloxane solutions.

The intra-chain and end cap polyorganohydrogensiloxane units of the polymer (ii) are preferably selected from the formulas ii-I and ii-II.
ii-I: -O-Si R ² HO-
ii-II: -O-Si R ² ₂ H,
More preferably, the polymer (ii) is selected from formulas ii-III and ii-IV.
ii-III: P ⁱⁱ -O-Si R ² HOP ⁱⁱ
ii-IV: P ⁱⁱ -O-Si R ² ₂ H
(P ⁱⁱ represents the rest of the polymer chain which may incorporate the same or different units, and one or more groups R ² are from C _1-20 alkyl groups, C _5-20 allyl groups, and combinations thereof. (For example, an organogroup appropriately independently selected from a methyl group, an ethyl group, a propyl group, a butyl group, a pentyl group, a hexyl group, a heptyl group, an octyl group, a nonyl group, and / or a decyl group).

The polymer (ii) preferably incorporates one or more units ii-I and / or ii-II, and one or more units ii-V and / or iiVI, polyorganohydrogensiloxane-polydi. Includes organosiloxane copolymer.
ii-I: -O-Si R ² HO-
ii-II: -O-Si R ² ₂ H
ii-V: -O-Si R ² ₂ -O-
ii-VI: -O-Si R ² ₃
(R ² is as defined above, more preferably a copolymer incorporating a polyorganohydrogensiloxane end cap unit, i.e. a polymer chain terminated at group or group ii-VII).
ii-VII: ≡ Si-H, more specifically, those having the unit of formula ii-II: -O-Si R ² ₂ H as defined above. Most preferably, the polymer (ii) comprises a methylhydrogensiloxane-dimethylsiloxane copolymer.

The polymer (ii) also exhibits at least two hydrogen atoms per molecule attached to silicon, preferably at least three ≡SiH units, eg, 1-5000 mPa.s, ie as defined above. It may contain a polyorganosiloxane having a viscosity of 0.001-5 Pa.s below 300 Pa.S, whereby when combined with additional component B components in component B, component B is in the range as defined above. In particular, it can be formed in the syroxyl unit of the following equation.

(-X is an alkyl group with 1 to 8 carbon atoms such as methyl, ethyl, propyl, and a cycloalkyl group such as 3,3,3-trifluoropropyl group, cyclohexyl, cycloheptyl, and cyclooctyl groups. , And a monovalent hydrocarbon group generally selected from aryl groups such as xylyl, trill, and phenyl, which do not have an unfavorable effect on the activity of the catalyst.
--g = 1, or 2, preferably = 1, i = 0, 1, or 2, g + i = 1, 2, or 3)
Optionally, all other units are the units of the following average equation.

(X has the same meaning as above, j = 0, 1, 2, or 3)

An example of polymer (ii) is a copolymer of polymethylhydrosiloxane or methylhydrodimethylsiloxane.

If the polymers contain, for example, iIII, iIV, iII, and iiII plus other units, they will not react properly with the respective polymers under ambient temperature or sterile conditions.

Appropriately, the ratio of the silicon-bonded hydrogen atom provided by (ii) to the silicon-bonded alkenyl moiety provided by (i) is at least 0.5: 1, preferably 1: 1.

Preferably, embodiments of curable constructs follow a catalytic addition curing reaction according to the following scheme.

P ^{i --R Alk1 --CR Alk1} = CR ^Alk2 ₂ + P ⁱⁱ + SiHR ² R ^{2 / P} → [catalyst]
P ^{i --R Alk1 --CHR Alk1} CR ^Alk2 ₂ ^{--SiR 2} R ^{2 / P} P ^{i i}
More preferably

(Integer is like defined above, R ^{1 / P} is selected from P ⁱ and R ¹ as defined above, R ^{2 / P} is as defined above P ⁱⁱ and R ⁽ Selected from ² )

The polymers (i) and (ii) and the catalyst (iii) are at least one component A in such a way that they provide the respective components A and B that do not react separately under ambient temperature or sterilization conditions such as heat or radiation. And may be allocated to at least one component B. Allocation may also be determined according to volume and viscosity.

Polymers (i) and (ii) and catalysts (iii) either lack polymer (ii) from component A and polymer (i) from component B, or component B has a molar ratio of 2000 or greater (Si). It may be allocated to at least one component A and at least one component B in a manner that incorporates a trace amount of polymer (i) represented as -H units or parts) / (alkenyl units or parts). Such constructs may be sterilized with effective gamma rays or radiation doses, for example, as disclosed in WO 2012/069794, the contents of which are incorporated herein by reference.

At least one component A and at least one component B may be of substantially equal volume and viscosity, or of different volumes and / or viscosities. Component A or Component B may incorporate a suitable viscosity modifier or diluent that increases or decreases the volume and / or viscosity in total. Thereby, the volumes and viscosities of component A and component B having different volumes and viscosities may be matched to make mixing and distribution easier and closer. Suitable diluents are, for example, silicone oils available at any desired viscosity for thickening or thinning effects. Alternatively, or in addition, at least one component A and at least one component B are within 28 hours, as disclosed, for example, in WO 2012/069793, the contents of which are incorporated herein by reference. Sealed within each receptacle or on each support, which is thermally stable at temperatures above 121 ° C. for a period of time.

Thereby, the constituents may be extremely sterilized by being sterilized within their primary packaging, and this property may be characterized by a guaranteed sterilization level (SAL). SAL is specified in ISO 11139: 2006 as the possibility of a single viable microorganism in the sterilized item. The term SAL is a quantitative value in the form 10 ^-n , generally n = 3, 4, 5, or 6, preferably SAL = 10 ^-3 or 10 ^-6 .

The catalyst as defined above may be any catalyst effective for catalyzing the addition curing reaction, as defined above, more preferably as illustrated above. Suitable catalysts include, for example, platinum, rhodium, palladium, nickel, as disclosed in US5,153,231, US2006 / 0217016, US3,928,629, and US4,529,553, the contents of which are incorporated herein by reference. It is selected from any known form of the addition-curable hydrosilylation catalyst.

Platinum catalysts include silica such as silica gel or carbon such as powdered activated carbon, platinum chloride or hexachloroplatinic acid and their alcohol solutions, salts of platinum acid and hexachloroplatinic acid, and platinum / olefin, platinum / alkenyl siloxane, platinum / β. -Platinum chloroplatinate may be selected as deposited on a carrier, including platinum complexes such as diketone, platinum / phosphine. Hexachloroplatinic acid may be in hexahydrate or anhydrous form. Platinum complexes are optionally from hexachloroplatinic acid and its hexahydrate, or from platinum chloride, platinum dichloride, platinum trichloride, and complexes neutralized with divinyltetramethyldisiloxane, optionally dimethylvinylsiloxy end cap polydimethyl. It may be prepared by diluting with siloxane.

The palladium catalyst may be selected from palladium carbon, palladium chloride and the like.

The rhodium catalyst may be selected from rhodium chloride and one or more rhodium complexes having the general formula iii-I or iii-II.
(iii-I) RhX ₃ (SR ₂ ) ₃
(iii-II) Rh ₂ (CO) ₄ X ₂
(X represents a halogen atom, R represents an alkyl or allyl radical having 1 to 8 carbon atoms or a combination thereof, or Q is a divalent aliphatic hydrocarbon having 1 to 6 carbon atoms. It represents a radical, R 'an alkyl or allyl radical, or a combination thereof having 1 to 8 carbon atoms, or no more than one R per molecule,' is _{(CH 3) 3 Si (CH} 3) 3 Si represents a group, represents a R _'3 SiQ group. for example, rhodium chloride / di (n- butyl) sulfide sulfide complex, etc.)

Nickel catalysts are preferably from M2Ni (0) such as bis (1.5-cyclo-octadienyl) nickel (Ni (COD) ₂ ), as well as MNi ⁽⁰⁾ G (M is C _6-12 bidentate alkene cyclic hydrocarbons). A hydrogen ring, where G is selected from monodentate and bidentate phosphite groups with hydrogen atoms, with substituted or unsubstituted hydrocarbon radicals or mixtures thereof attached to the phosphite atom of the phosphite group). Zero-valent nickel selected from.

The composition may include a catalyst inhibitor. Suitable inhibitors are known in the art.
For example, the catalyst inhibitor is selected from polymethylvinylsiloxane cyclic compounds and acetylene alcohols, such as methylbutinol as disclosed in US5153231 which is similar to Cavi-Care or whose contents are incorporated herein by reference. May be done.

Preferably, the composition comprises an addition reaction retarder or a crosslink inhibitor.
The addition reaction retarder or cross-linking inhibitor may be, for example, the following compounds, i.e., polyorganosiloxanes substituted with at least one alkenyl, optionally cyclic, particularly preferably tetramethylvinyltetrasiloxane, and organic. It is selected from phosphines and phosfits, unsaturated amides, alkyl maleates, and acetylene alcohols.

These acetylene alcohols (see FR-A-1 528 and FR-A-2 372874) have the following formulas, among other preferred heat blockers for hydrosilylation reactions.
(R') (R'') C (OH) -C≡CH
(R'is a linear or branched alkyl radical, or phenyl radical, and R'' is a linear or branched alkyl radical, or phenyl radical. Radicals R', R'' and carbon for triple bonds. The atom α forms a ring in some cases, and the total number of carbon atoms contained in R'and R'' is at least 5, preferably 9 to 20).

Examples that may be mentioned include:
1-Etinyl-1-cyclohexanol
3-Methyl-1-dodecin-3-ol
3,7,11-trimethyl-1-dodecin-3-ol
1,1-diphenyl-2-propin-1-ol
3-Ethyl-6-Ethyl-1-Nonin-3-ol
2-Methyl-3-butyne-2-ol
3-Methyl-1-pentadesin-3-ol

These α-acetylene alcohols are commercially available products. Such retarders are present in a ratio of up to 3000 ppm to the total weight of the polyorganosiloxane in the silicone composition. Methylbutinol can be selected as in Cavi-Care.

The constituents may be non-foaming or (iv) selected from H donors, OH containing agents, H binders, such as, for example, as part of or during the curing reaction, gas or It may be effervescent, including a swelling or "foaming" agent selected from any agent that emits vapor.
Alcohols containing methanol, ethanol, n-propanol, isopropanol, n-butanol, 2-butanol, 3-butanol, n-hexanol, n-octanol, and benzyl alcohol. Particularly preferred are n-propanol, n-butanol, n-hexanol, and n-octanol.
Polyols such as 4-butanediol, 1,5-pentanediol, and diols containing 1,7-heptanediol Silanes or polysilanes with at least one silanol group, or
water.

After hydrosilylation, the composition forms a silicone elastomer that may foam or have gel properties. The foamed composition does not transmit air through the foam body and / or the foam surface and confine the cell, for example, by either chemical or mechanical means. The term "silicone gel" refers to a crosslinked silicone product characterized by a penetrance of, for example, 20/10 to 500/10 mm (measured by ASTM D 2137 Penetrance Measurement Method, rod and cone weight 62.5 g).

If the composition is prepared for a silicone gel, it may have at least one non-functionalized polyorganosiloxane, including:
^{a) M = (R 6)} 3 SiO 1/2 type terminal siloxyl units (or different R ⁶ radicals are identical, optionally substituted linear or branched C ₁ -C ₆ alkyl groups and / Or equivalent to a substituted or unsubstituted aryl group), and
^{b) D = (R 7)} 2 SiO 2/2 types of the same or different siloxyl units (R ⁷ radical corresponds to the same definition as R ⁶⁾

The physical properties of these gels are those of non-functionalized polyorganosiloxanes, well known in the art, by varying the levels of siloxyl units with Si-alkenyl and SiH functional groups, and if present. Adjusted according to application by varying the weight percent.

To improve the adhesiveness of the silicone gel, the composition is further monofunctional polyorganosiloxane with a single Si-alkenyl group per molecule, as taught by European patent application EP-1633830-A2. It may be included.

In addition, the composition may also contain an inorganic filler such as a reinforced or bulk filler. These fillers can be provided in the form of very finely divided products, the average particle diameter of which is less than 0.1 μm. These fillers include, in particular, fumed silica and precipitated silica, their specific surface areas generally in excess of 10 m ² / g and generally in the range of 20-300 m ² / g.

These fillers can also be provided in the form of coarsely divided products with an average particle diameter of more than 0.1 μm. In particular, examples of such fillers include quartz powder, calcium carbonate, diatom silica, calcined clay, rutile-type titanium oxide, iron oxide, zinc oxide, chromium oxide, zirconium oxide, or magnesium oxide, various forms of alumina ( Hydrated or non-hydrated), boron nitride, lithopone, or barium borate may be mentioned, and their specific surface area is generally less than 30 m ² / g.

The filler may have a hydrophobic surface, which may be obtained by treating the filler with, for example, a suitable silane, short chain siloxane, fatty acid, or resinous silicone material.

Fumed silica treated with hexamethyldisilazane may be considered, or vinyl "Q" reinforced resins may be used if translucency is maintained. The filler may be hydrophobic. Suitable materials and processes for making the surface of the filler hydrophobic have been described in the literature and are known to those of skill in the art. The filler can also be composed of a mixture of several types of fillers with different particle sizes.

The composition may include a thixotrope. The thixotrope gives the composition the property of becoming viscous during application and returning to a higher viscosity when it ceases to work after application. Tixotropes contain fillers such as silica and certain silicone-based materials.

Constituents prevent other auxiliaries, preservatives containing propyl gallate, bulking agents, rheology modifiers, adhesion promoters or adhesive weakeners, transpiration of the skin to which the composition is applied, thereby making the skin liquid. May contain additional components, including moisture permeability (MVP) or water vapor permeability (MVTR) accelerators, which evaporate and pass through but still serve as sealants and bacterial barriers. Appropriately, such additional components provide the composition with properties as defined above.

The construct may have any desired activity for the intended purpose, may include a pharmaceutical active ingredient (API), etc., or may contain an activator.

Antibacterial substances, biocidal agents, and bactericides include silver, especially nanocrystalline silver, as well as silver complexes and salts (ion silver, silver zeolite, silver oxide, silver nitrate, silver acetate, silver chloride, silver sulfaziazine, etc.), polyhexa Biguanides containing methylene biguanides, chlorhexidine digluconate and its acetates, acetic acid and chlorhexidine diacetate, manuka honey, peroxides (eg hydrogen peroxide), iodine (eg povidone iodine), sodium hypochlorite, copper, copper Derivatives containing complexes, zinc (eg, zinc oxide, zincpyrythion), gold, gold complexes, phosphoric acid, amines, amides, and sulfonamides (eg, hexatidine, proflavin, maphenide, nitroflazone, norfloxacin), antibiotics (eg, norfloxacin). It may be selected from gentamycin, bacitracin, rifampicin, alcohols and acids (eg, ethanol, phenoxyethanol, mupyrosine).

Nutrients, analgesics, and other pain management techniques appropriately include analgesics and anesthetics, anti-inflammatory drugs such as amesocaine, lignokine, non-steroidal anti-inflammatory drugs, hydrocortisone, paraffins that reduce adhesion to the skin, It may be selected from urea, which reduces skin dehydration, and a buffer component, which promotes skin healing.

Hemostatic agents include chitin, chitosan, kaolin, antifibrinogen solubilizers (amino acids, aminocaproic acid, tranexamic acid, aminomethylbenzoic acid, etc.), proteolytic enzyme inhibitors (aprotinin, α1-antitrypsin, C1-inhibitors, camostats). , Vitamin K and other hemostatic agents (vitamin K, phytomenadione, menadione), fibrinogen including human fibrinogen, topical hemostatic agents (absorbable gelatin sponge, cellulose oxide, tetragalacturonic acid hydroxymethyl ester, adrenaline, thrombin, collagen , Calcium alginate, epinephrine, etc.), blood coagulation factors (combination of coagulation factors IX, II, VII, and X, coagulation factor VIII, factor VIII inhibitor diversion activity, coagulation factor IX, coagulation factor VII, von Willebrand factor and coagulation It may be selected from a combination of factors VIII, coagulation factor XIII, eptacogalpha (activated), nonacogalpha, thrombin, and systemic hemostatic agents, etc.), ethanecilate, carbazochrome, batroxobin lomiprostim, elthrombopag.

Activators are superabsorbents, fragrance control agents, woven and non-woven fabrics, gelling fibers, growth factors, wound debridement (mechanical, autolytic, and enzymatic), absorbent coatings that affect cell growth. And may further include combinatorial materials including microstructures, cells, tissues (eg, autolysis), indicators, dyes and colorants and colored indicators, bleaching agents such as zinc oxide and titanium oxide.

The composition can be any pallet knife, syringe, static mixer, roll-on applicator, spray, wipe, brush, foam, sponge, non-woven fabric, partial or fully integrated into a dressing, or manual application. It may be in a form that can be distributed by a known method. Applicators that use sponges have been demonstrated at Chloraprep, http: /www.chloraprep.co.uk. For a two-part curing system that requires mixing, a static mixer such as a double-cylinder syringe with a mixing head may be used.

Therefore, preferably, the curable two-part construct is sealed within each receptacle or on a support suitable for collaborative distribution from a collaborative distribution device, preferably a double tube syringe. Provided as at least one component A and at least one component B sealed in each cylinder or cassette for static mixers such as, more preferably with a collaborative distribution device such as a static mixer. Will be done.

More preferably, a syringe with a nozzle that allows the material to be inserted into the exposed transmission layer, or a spreader tip that allows the material to spread over the entire edge of the cut transmission layer, or a combination thereof. Spreaders with protruding apertures may be used (eg, Double-Syringe Prefilled Delivery System (L-System) mated with static mixers and spreader tips), Medmix Systems Ag, http: // www. medmix.ch/L-SYSTEM.html).

For certain embodiments, there is a clear advantage to using an applicator with an integrated spreader. When the material is applied directly to the cut covering edges, especially in the case of extended cut edges, it is advantageous to manipulate the material to ensure optimal placement. The integrated spreader minimizes mutual contamination as the sealant is manipulated. Mutual contamination during operation includes contamination of the sealant by the amount of contaminated microorganisms, contamination of the sealant by foreign matter, contamination of the sealant by chemicals (such chemicals may have an effect on the sealant), and sealant by personnel or equipment. May be related to contamination. For other embodiments, it is advantageous to use an applicator without a spreader, for example to fill gaps in the body.

If the composition is a curing system, chemical contamination can adversely affect the curing process. For example, if the composition is platinum-catalyzed RTV-2 silicone, contact with gloves containing latex or nitrile may affect curing. The problem caused by the given example is documented in dental publications regarding the delay in coagulation when polyvinylsiloxane dental impression material is mixed with certain types of gloves (Y. Walid, Z. Al-Ani and). R. Gray, Silicone impression materials and latex gloves. Is interaction fact or fallacy ?, Dent Update, 2012, 39, pp. 39-42).

In medical institutions, therefore, the applicator integrated with the spreader overcomes the obstacle that clinicians cannot use gloved fingers (exposed to the chemical constituents of gloves) to manipulate the sealant. Overcomes the possibility of using ungloved fingers, thus eliminating contact with the patient with bare hands (this strategy is not only inappropriate for most medical institutions, but the hardened components are clinical (Tends to move to the fingertips to the doctor), and also overcomes the requirement for any other medical device or instrument to be contaminated with the cured composition.

Distributing may be by a syringe or static mixer with nozzle heads, as defined above and as defined below, with a combination of spreader tips and multiple nozzles, eg, The spreader has multiple protruding apertures. Preferably, the nozzle head comprises 3 to 6 nozzles, such as 2 to 10 nozzles, for example 3 or 5 nozzles. The nozzle preferably has a low aperture ratio because it distributes the sealant to the inner portion within the exposed portion of the transmission layer. For example, the spread of the nozzle head may match the width of the crosslinked portion to allow distribution with a single insertion. This embodiment of the dispenser for the components and the mode of distributing the components is by reducing the load and requirements on accuracy on the operator's side, improving the distribution position and the mechanical accuracy of continuous seal formation. Make a profit. Also, the back pressure in the syringe may be slightly reduced to allow the use of more viscous constructs. Substantial boundary areas as defined above may contribute to the integrity of the seal.

Preferably, the nozzle head has 2-4 nozzles, such as 2 or 3 nozzles, and is of a suitable width or moderate width for distribution within the exposed portion of the transmission layer on a curve, eg, the contour of the body. Has a head spread. The alternative multi-nozzle head is flexible or deformable in two positions and has curved, eg, body contours, distribution within the exposed portion of the transmission layer, and / or closed access. It makes it easy to distribute within. Such nozzle heads include flexible arms or restraining means through which a plurality of nozzles exit. The arm is joined to the main nozzle head, thereby being releasably joined to the static mixer, optionally via a flexible tube. The arm may be bent to fit the arc. The tube may be bent to fit as well to produce an angled nozzle. The tube may beneficially increase the angle of incidence for distribution.

Flexible arms are generally not elastic, i.e., retain the shape given for distribution until they are bent back to their original shape or different form. The flexible arm can be made of a deformable polymer or putty, etc., or can be a mechanically flexible or deformable arm (ie http://snakeclamp.com/ or http. //jobv.com/qorillapod).

Preferably, the dispenser has a low profile and can be contained within a virtual cone. This can advantageously be considered in the design of the dispenser, which allows for a shallow angle of incidence on the skin, allowing the nozzle to be inserted into the exposed portion of the transmission layer of the dressing adhered to the patient. Decide.

Preferably, the sealant is a TNP sealant that produces or improves a liquidtight, preferably airtight seal.

In one embodiment, the composition comprises an RTV-2 silicone such as Silpuran 2445 ™, which may be optionally modified to have a viscosity as defined above. Viscosity modification is as known in the art and, appropriately, incorporates a filler such as, for example, fumed silica, or optionally a translucent filler or resin or reinforced resin as defined above. By achieving the viscosity defined above, or by combining components A and B and pre-reacting to achieve the viscosity defined above before application. The increase in curing rate is as known in the art, for example, increasing the amount of catalyst, or decreasing the amount of catalyst inhibitor, if present.

Preparation Method A further aspect is the preparation of the constituents as defined above. Methods for preparing non-curable or curable constituents as defined above with one or more components are known in the art. Preferably, the method comprises loading the construct or parts thereof into an applicator or cassette thereof as defined above.

A further embodiment is a method of preparing a curable composition as defined above.
Polymers (i) and (ii) and catalysts (iii) as defined above can be combined and dispensed in a manner suitable for collaborative dispensing, for example from a double tube syringe. Includes the steps of forming at least one component A and at least one component B.

Sterilization Method A further aspect is the method of sterilizing a curable composition as defined above, in which one or more components are sealed, eg, on their respective thermally stable receptacles or supports. At least one component A and at least one component B are heated at a high temperature of 121 ° C. or higher for a period of up to 28 hours, or in the case of a two-part curable composition, the polymers (i) and (ii). ) And the catalyst (iii), the polymer (ii) is missing from component A and the polymer (i) is missing from component B, or the component B is in a molar ratio of 2000 or greater (Si-H units or moieties) / Effective sterile doses of gamma, x-ray, and when distributed to at least one component A and at least one component B, such as incorporating trace amounts of the polymer (i) represented as (alkenyl units or moieties). It involves heating by irradiating with a radiation source selected from the group consisting of electron beam radiation.

Device A further aspect is the form of a device suitable for use in the field of wound care, comprising a distribution device having one or more cylinders or cassettes, advancing means, and any mixing means, said one. The above cylinder or cassette comprises the components as defined above, and in the case of two or more parts of the structure, components A and B are contained in the respective cylinders or cassettes and the device contacts the respective parts. Have a means.

Preferably, any mixing means, contacting means, and / or advancing means are provided integrally with the device or separately from the device. The mixing means may be static or dynamic. The device may incorporate a dwell chamber for partial curing to a higher viscosity before the mixed components A and B are dispensed.

Preferably, the device is disposable with one or more integrated cylinders or cassettes.

Preferably, the device comprises an applicator for applying the construct, which comprises means of constructing the construct upon application, eg, an applicator with a nozzle or an integral spreader or a combination thereof. .. Preferably, the device comprises a nozzle head with a combination of a spreader tip and a plurality of nozzles, as defined above and as defined below, for example, the spreader has a plurality of protruding apertures. Preferably, the nozzle head comprises 3 to 6 nozzles, such as 2 to 10 nozzles, for example 3 or 5 nozzles. The nozzle preferably has a low aperture ratio because it distributes the sealant to the inner portion within the exposed portion of the transmission layer. For example, the spread of the nozzle head may match the width of the crosslinked portion and may be distributed and enabled with a single insertion. This embodiment of the dispenser for the components and the mode of distributing the components is by reducing the load and requirements on accuracy on the operator's side, improving the distribution position and the mechanical accuracy of continuous seal formation. Make a profit. Also, the back pressure in the syringe may be slightly reduced to allow the use of more viscous constructs. Essential boundary areas as defined above may contribute to the integrity of the seal.

Preferably, the nozzle head has 2-4 nozzles, such as 2 or 3 nozzles, and is of a suitable width or moderate width for distribution within the exposed portion of the transmission layer on a curve, eg, the contour of the body. Has a head spread. The alternative multi-nozzle head is flexible or deformable in two positions and has curved, eg, body contours, distribution within the exposed portion of the transmission layer, and / or closed access. It makes it easy to distribute within. Such nozzle heads include flexible arms or restraining means through which a plurality of nozzles exit. The arm is joined to the main nozzle head, thereby being releasably joined to the static mixer, optionally via a flexible tube. The arm may be bent to fit the arc. The tube may be bent to fit as well to produce an angled nozzle. The tube may beneficially increase the angle of incidence for distribution.

Flexible arms are generally not elastic, i.e., retain the shape given for distribution until they are bent back to their original shape or different form. The flexible arm can be made of a deformable polymer or putty, etc., or can be a mechanically flexible or deformable arm (ie http://snakeclamp.com/ or http. //jobv.com/qorillapod).

Preferably, the dispenser has a low profile and can be contained within a virtual cone. This can advantageously be considered in the design of the dispenser, which allows for a shallow angle of incidence on the skin, allowing the nozzle to be inserted into the exposed portion of the transmission layer of the dressing adhered to the patient. Decide.

In a further embodiment, a novel device as defined above is provided, comprising a nozzle head with a combination of a spreader tip and a plurality of nozzles, as defined above and as defined below. For example, a spreader has multiple protruding apertures. Preferably, the nozzle head comprises 3 to 6 nozzles, such as 2 to 10 nozzles, for example 3 or 5 nozzles. Further features are as described above.

If desired, these systems may be used with a suitable skin-compatible sealant on the outer circumference, as defined in PCTGB2012 / 000866.

The dressing as defined above may be any wound dressing, preferably a wound dressing having a Si wound contact surface, more preferably having an outer peripheral region as defined above. TNP dressing, optionally modified as such. Known TNP coatings include: Smith & Nephew's RENASYS-F / AB, abdominal covering kit, Smith & Nephew's disposable kit, Smith & Nephew's RENASYS-F / P, ported foam covering kit, Smith & Nephew's RENASYS-G, gauze covering kit , Smith & Nephew's PICO ™ Covering Kit, and KCI Kits for TNP, including the VAC ™ Granufoam Covering Kit. Additional dressings and methods for treating wounds using negative pressure are disclosed in the following applications incorporated herein by reference. US Application No. 13 / 381,885 filed on December 30, 2011 and published as US 2012/0116334, US Application No. 12 / 886,088 filed on September 20, 2010 and published as US 2011/0213287, US Application No. 13 / 092,042 filed on April 21, 2011 and published as US 2011/0282309, US Application No. 12 / 744,277 filed on September 20, 2010 and published as US 2011/0028918, And US Application Nos. 12 / 744,218 filed on September 20, 2010 and published as US2011 / 0054421, as well as WO2011 / 00622, WO 2011/000621, WO2011 / 135285, WO2011 / 135286, US7964766, and US7615036 ( All Smith & Nephew). Its contents are incorporated herein by reference.

A conventional TNP dressing is applied by placing a drape on it, the second surface of which is airtight. Such dressings can further include a tissue (wound) contact layer, a negative pressure distribution and transmission layer, and any wound exudate absorption layer, as defined above.

Preferably, the composition is distributed to a synthetic TNP dressing, such as a PICO ™ dressing. The synthetic dressing incorporates an integral airtight backing layer (also referred to herein as a wound cover or drape), which is one or more negative pressure transfer or distribution layers, tissue (wound) contact layers, wounds. It may be made of a gas impermeable membrane and an integral TNP treatment layer, such as an absorbent material layer such as a leachate absorption layer or an acquisition partitioning layer (ADL), any of which is optionally a superabsorbent polymer ( SAP) is included, the layer is located below the backing layer, and the backing layer or wound cover can optionally allow evaporation or liquid evaporation from the wound exudate, for example PICO ™ dressings. To do.

For example, one or more transmission layers or other layers may be positioned or encapsulated between the backing layer and any wound contact layer. One or more transmission layers may then be encapsulated between the backing layer (optionally with the wound contact layer) and the wound site on which the dressing is configured to be located, eg, they. It may be enclosed between. The synthetic coating may be supplied with a number of adhesive strips composed of drape material, or with a sealant as disclosed in PCT / GB2012 / 000866, the contents of which are incorporated herein by reference. The strip may be omitted depending on the seal.

Thus, the composition may be applied to any dressing that is desired to be cut, contoured or articulated to size or shape. Cutting is simply by removing the excess and retaining the required part, including the negative pressure port.

Preferably, the composition is distributed into a trimpable coating that has an additional coating or a main coating that communicates fluid (gas) with the cell. One or more additional parts or cells may be removed to provide a dressing with a size or shape or profile or joint that is compatible with the wound or wound site to which the dressing is applied. Preferably, the portion or cell may be retained to provide a large surface area or elongated covering material to a similarly large surface area or elongated wound, or the portion or cell may be reduced accordingly. It may be removed to coat a wound with a new surface area or reduced length, preferably one or more additional parts or cells to coat a wound of similar shape. Alternatively, it may be adapted to provide a shaped covering material, such as a fixed device (eg, a pin), or a covering material for a wound that incorporates or is adjacent to a protrusion of a body part (such as a finger). Contoured covering material, preferably because one or more additional parts or cells coat a wound or wound site of similar contour, such as a wound located on a complex body topography. May be adapted to provide, preferably one or more additional parts or cells are articulated to cover similarly articulated wounds or wound sites, such as wounds located at joints. May be done.

In one advantage, the composition is disclosed in US Provisional Patent Application No. 61 / 800,040 dated March 15, 2013, entitled "WOUND DRESSING AND METHOD OF TREATMENT", the contents of which are incorporated directly herein by reference. It may be used to seal a trimming dressing, as described above.

Trimmable dressings are preferably wound healing devices for treating wound sites.
A backing layer that has an upper surface and a lower surface and defines an outer circumference configured to be located on the skin surrounding the wound site.
A transmission layer configured to be positioned below the backing layer,
With one or more ports configured to transmit negative pressure through the backing layer to apply local negative pressure at the wound site
The device comprises a plurality of cells or areas separated by one or more trimmable portions. The one or more trimmable portions may be crosslinked portions as defined above.

In some embodiments, the plurality of cells form a plurality of repeated negative pressure treatment modules. In one embodiment, one or more of the modules can be removed and the removed one or more modules can be subsequently used to provide negative pressure to the wound site. In another embodiment, one or more modules can be removed and the remaining one or more modules can be subsequently used to provide negative pressure to the wound site. In a further embodiment, the trimpable portion has a maximum width of 50 mm (or about 50 mm), 40 mm (or about 40 mm), 30 mm (or about 30 mm), 20 mm (or about 20 mm), or even 15 mm (or about 15 mm). May have. In some embodiments, the trimpable portion may be 10 mm to 20 mm (or about 10 mm to about 20 mm). The trimmed portion may include one or more crosslinked portions having a narrower width compared to the width of adjacent cells or regions. For example, the crosslinked portion may have a maximum width of 1/8, 1/4, or 1/3 (or about 1/8, 1/4, or 1/3) of the width of the adjacent cell or region. Good. Multiple cells or regions may include an absorbent material, which is located between the transfer layer and the backing layer. One or more trimmable portions may include an absorbent material, which is positioned between the transfer layer and the backing layer. In other embodiments, no absorbent material is positioned between the transfer layer and the backing layer. Some embodiments may further include an acquisition distribution layer having a footprint similar to that of the transmission layer, the acquisition distribution layer being configured to be positioned above the transmission layer. The device is preferably as defined further below.

One or more exposed areas as defined above are the result of removing a portion of the wound dressing, which is due to any conceivable means, such as cutting or tearing the wound dressing along the line of weakening. It may be a thing. The synthetic wound dressing may provide a boundary for anchoring around the wound, centered on the central wound contact area. A dressing as defined above has a footprint or surface area similar to that of the intervening transfer layer or other layer (ie, a rimless dressing), or a foot larger than the intercalated transfer layer. It may include a print or surface area (ie, rimmed dressing), a backing layer and a wound contact layer. One or more exposed areas, as defined above, are directly encapsulated with the transmission layer or other layer, for example, by cutting into or cutting through the backing layer and the wound contact layer and the transmission layer between them. Obtained by removing a portion of the wound dressing as defined above.

The dressing embodiments described herein provide a dressing in a range of sizes or shapes suitable for irregularly shaped wounds and body topography, which is impractical for both manufacturers and users, eg, for individuals. Address the challenge of providing post-venous wound dressings that adapt to elongation and leg length variations. The embodiment improves the adaptability of existing dressings, including more recently introduced multisite dressings such as three-leaf and four-leaf. Depending on the particular embodiment, removing a portion of the dressing to create a major wound dressing that seals the desired size or shape or profile or joint, as well as one or more exposed parts thereof, to contain negative pressure. Becomes possible.

One or more parts of the wound dressing are sized so that they are positioned on top of the wound as defined above, such as an incision wound, an elongated leg wound, an arched incision wound, etc. May be removed. Similarly, one or more parts of the wound dressing should be located on the wound as defined above, such as a flap wound, and around a protruding device, such as a fixed device or a protruding body part, so that the primary wound dressing is located. To shape a portion, on a wound as defined above, eg, to outline a major wound dressing, to position on complex body topography, or, eg, on a wound as defined above. It may be removed to join the main wound dressing onto the flexing joint.

The wound healing device may be wrapped in a tape that can be cut along one or more crosslinked sites. Cutting along the crosslinked portion may cut adjacent cells.

Alternatively, the construct may be advantageously distributed to perform a dressing sealing to treat the wound site, the dressing.
A backing layer with upper and lower surfaces, or a backing sheet that defines the outer circumference configured to be located on the skin surrounding the wound site, as referred to above.
With a transmission layer that is located below the backing layer or configured to be located on one side of one side of the backing sheet,
It has a plurality of ports, which are separated on the backing layer and are configured to transmit negative pressure.

The wound treatment device may be configured to be wrapped in tape. Each of the ports may include an opening in a backing layer covered with an openable tab. The transmission layer may include one or more crosslinked portions having a width narrower than adjacent portions of the transmission layer. Negative pressure may be established at the wound site by any one of the ports, the rest of the ports may remain sealed, or may be removed with a compartment of dressing. Good. The wound treatment device may be used at any desired length by cutting between adjacent ports.

In the dressing described above, the wound treatment apparatus further comprises an optional wound contact layer, with one or more transmission layers positioned between the backing layer and the wound contact layer. The one or more transmission layers may be in direct or indirect contact with the lower surface of the backing layer. In some embodiments, the one or more transmission layers include a first layer that includes a spacer material configured to suck up the fluid vertically. The one or more transmission layers may further include a second layer, including an acquisition partition layer configured to suck up the fluid horizontally, the second layer being positioned above the first layer. .. One or both of the first layer and the second layer may be present in one or more crosslinked moieties. In other embodiments, one or more transmission layers include an acquired distribution material configured to suck up the fluid horizontally. In some embodiments, the port may include an opening in the backing layer. The port may include a port member attached to the backing layer above the opening in the backing layer. The port member may be sealed on the upper surface of the backing layer. Some embodiments may further include an absorbent material between the backing layer and the transmission layer, which has a footprint similar to one or more transmission layers. The absorbent material may or may not be present in one or more crosslinked moieties as defined above. Some embodiments of one or more transmission layers may further include an acquired partitioning layer between the backing layer and any wound contact layer, the transmission layer and / or the absorbent layer being an absorbent material. And / or has a footprint similar to the absorbent layer. One or more transmission layers may further include a spacer material configured to distribute negative pressure, the spacer material having a footprint similar to the acquisition distribution material, and the spacer material below the acquisition distribution material. It is configured to be positioned in. The acquisition partition layer or material may or may not be present in one or more crosslinked moieties as defined above. The acquired distribution material may be provided as a transfer material or layer.

The transmission layer (hereinafter, one or more layers) may have a rectangular shape having a longitudinal axis extending along its length. The transmission layer may include one or more crosslinked portions centered on the longitudinal axis. The transmission layer may include three or more crosslinked portions centered on the longitudinal axis. The one or more crosslinked portions may also be offset from the longitudinal axis. The one or more cross-linked portions may have a width of less than 1/3 of the adjacent portion of the transmission layer. The one or more cross-linked portions may have a width of less than 1/4 of the adjacent portion of the transmission layer. The one or more cross-linked portions may have a width of less than 1/8 of the adjacent portion of the transmission layer. As used herein, the narrower width represents a narrowing or neck or narrowing of the transmission layer relative to its adjacent portion. The transmission layer may have a T-shape with a cross-linked portion on each leg of the T. The transmission layer may have a T-shape with at least one cross-linked portion on each leg of the T. The transmission layer may include multiple cells, each separated by one or more crosslinked moieties. The transmission layer may comprise a plurality of cells, each of which is connected to at least one adjacent cell by one or more cross-linked moieties, preferably the bridge providing gas communication between the adjacent cells.

Some embodiments may further include a fluid connector configured to provide negative pressure to the port. Some embodiments may further comprise a negative pressure source configured to provide negative pressure through the port. Negative pressure may be established at the wound site by any one of the ports, or by multiple ports of the ports, and the rest of the ports may remain sealed, or It may be removed from a compartment of the covering material. Some embodiments may further comprise one or more separate or integral adhesive strips or seal strips. The strip retains and seals the backing layer against the skin surrounding the wound after the device has been cut along or across one or more crosslinks, i.e. between adjacent cells or ports. It is configured as follows. The strip may be composed of a backing layer material such as polyurethane or hydrocolloid, or a silicone-based material such as OPSITE FLEXIFIX or OPSITE FLEXIFIX Gentle.

In a further aspect, a novel device as defined above is provided. Therefore, a wound healing device for treating the wound site is provided, and the device
A backing layer that has an upper surface and a lower surface and defines an outer circumference configured to be located on the skin surrounding the wound site.
A transmission layer configured to be positioned below the backing layer,
With one or more ports configured to transmit negative pressure through the backing layer to apply local negative pressure at the wound site
The device comprises a plurality of cells or areas separated by one or more trimmable portions. The features are as defined above.

Each of the ports may include an opening in the backing layer covered with an openable tab, and negative pressure may be applied to the backing layer through at least one of the openings. Some embodiments may include multiple ports configured to transmit negative pressure through the backing layer, each port corresponding to a separate negative pressure treatment module. Some embodiments may further include a wound contact layer configured to be positioned below the transmission layer, further such that the wound contact layer seals against the backing layer around the perimeter. It is composed.

In some embodiments, the cells may be configured to be approximately the same size, approximately square, and grid. In other embodiments, the cells may be configured in a T shape. In other embodiments, the plurality of cells may be configured in a roll shape. In other embodiments, the cells may be configured in a linear arrangement. In some embodiments, the cells may each be configured with one or more ports. In other embodiments, at least two of the cells may be configured with one or more ports, respectively. The device may further include a negative pressure source connected to some or all of one or more ports. In some embodiments, the dressing may include an exposed portion of the transfer layer. The exposed area may be sealed with a sealant or adhesive material. The device is preferably further as defined above.

In some embodiments, at least one material layer of the first part is a reticulated open cell foam, woven fabric material, non-woven material, 3D knitted fabric, Baltex 7970 weft knitted polyester, acquired distribution material, DryWeb TDL2, SlimCore. Includes one or more transmission layers such as TL4. At least one material in the first part is, in addition to, or instead, an absorbent layer, such as a superabsorbent pad containing cellulose fibers and superabsorbable particles, MH460.101, ALLEVYN ™ foam, It can include Freudenberg 114-224-4, or Chem-Posite ™ 11C-450. In some embodiments, the crosslinked portion may be one or more of reticulated open cell foam, woven fabric material, non-woven material, 3D knitted fabric, Baltex 7970 weft knitted polyester, acquired distribution material, DryWeb TDL2, SlimCore TL4, etc. Includes at least one material layer. In some embodiments, at least one material layer of the crosslinked portion should transmit a negative pressure of at least -40 mmHg to a setpoint in the range of -60 to -200 mmHg, including an air leak of 50 cc / min. .. In some embodiments, at least one material layer of the crosslinked portion contains an air leak of 50 cc / min over a distance of about 20 mm ± 1 mm-at a set point of -200 mmHg, about -25 mmHg or less (ie by zero). You should experience a pressure difference (near). In other embodiments, at least one material layer of the crosslinked portion contains an air leak of 50 cc / min over a distance of about 20 mm ± 1 mm-at a set point of -200 mmHg, about -5 mmHg or less (ie by zero). You should experience a pressure difference (near). In some embodiments, the at least one material layer of the crosslinked moiety, in the uncompressed state, is at least 1 mm (or about 1 mm), at least 3 mm (or about 3 mm), at least 4 mm (or about 4 mm), or at least 5 mm (or at least 5 mm). Or about 5mm) and at least 1mm (or about 1mm), or at least 2mm (or about 2mm), at least 3mm (or about 3mm), at least 4mm (or about 4mm), or at least 5mm (or about 5mm) Has a width. In some embodiments, the at least one material layer of the crosslinked portion has a maximum height of 9 mm (or about 9 mm) in the uncompressed state because it is easier to reseal when cut. In some embodiments where the dressing is sealed with a sealant, at least one material layer can be elastic to compression, whereby the height of the sealed portion is non-compressed. It is substantially the same as the height of the sealed portion in the compressed state. In one embodiment, at least one material layer of the crosslinked moiety comprises a spacer material having a height of at least 2 mm (or about 2 mm) and a width of at least 1 mm (or about 1 mm). In one embodiment, at least one material layer of the crosslinked portion may experience a pressure difference of -8.9 (or about -8.9) mmHg when moistened, with a height of about 5 mm and a width of about 3 mm. Includes reticulated open cell foam with. In another embodiment, at least one material layer of the crosslinked moiety comprises an acquisition partition layer (eg, SlimCore TL4) having a height of about 2 mm and a width of about 4 mm. Such dimensions can represent the uncompressed dimensions of the material layer of the crosslinked portion. In one embodiment, at least one material layer of the crosslinked moiety is incompressible.

We have found that the compression ratio does not change or substantially does not change at the onset of negative pressure when the constructs are distributed to seal the coating in a manner as defined above. It is elastic or substantially elastic to the compression induced by the negative pressure, or receives a compression substantially similar to or lower than the seal of the construct at the onset of the negative pressure, ie, negative. In connection with exposed trimmed or bridged portions containing one or more layers of material, which have substantially equal or lower elasticity to the compression induced by pressure. We have found that we may provide advantageous seals. Especially in relation to the cured or solidified system, this relative compressibility is related to the cured elastomer or solidified seal. Preferably, the composition forms a seal that is substantially incompressible at the onset of negative pressure or is compressible to touch one or more layers of material, with less compression than the seal. .. Preferably, one or more trimmable or crosslinked moieties contain a material that is substantially elastic to the application of negative pressure, preferably one or more crosslinked moieties for application of negative pressure. On the other hand, it has a height that does not substantially change, and preferably has a reduction rate of 10% or less, more preferably 8%, and most preferably 5% when negative pressure is applied. This ensures a smooth surface for the dressing and minimizes the discomfort provided to the wearer when negative pressure is applied after the dressing is sealed, and also seals the dressing. If negative pressure is applied prior to the procedure and then temporarily interrupted, the seal remains intact and is guaranteed not to break.

In some embodiments, the crosslinked moiety comprises one or more layers that are the same as the first moiety. In other embodiments, the crosslinked moiety has fewer layers than the first moiety. In some embodiments, one or more layers of the crosslinked portion have a narrower width than one or more layers of the first portion. In some embodiments, one or more layers of the crosslinked portion have smaller dimensions than one or more layers of the first portion (eg, individual heights of one or more layers of the crosslinked portion or The combined height is lower than the height of one or more layers in the first part). In other embodiments, one or more layers of the crosslinked portion have the same width as one or more layers of the first portion. In some embodiments, the crosslinked portion connects the first portion to an adjacent portion having a layered structure and / or width similar to that of the first portion. In some embodiments, there are a plurality of cross-linked portions, where the first portion may be connected to a plurality of adjacent portions, or the plurality of adjacent portions may be connected to each other.

The kit and its components A further aspect comprises a dressing overlaid on the wound and the skin around it, which may be cut to the size or shape as defined above, along with the components as defined above. A kit used in the field of wound care.

Some kits include a vacuum pump.

For certain advantages, the kit, sealant composition, and / or dressing or wound cover may be extremely sterile. Techniques for sterilizing equipment such as dry heat, steam, and radiation are known. GB1020005.3, GB 1019997.4, and GB1104512.7 disclose extremely sterilizable bipartite components and methods for their sterilization. Methods include heat sterilization and radiation sterilization, especially gamma ray, electron beam, or X-ray radiation sterilization. Preferably, the sealant is extremely sterilizable or sterile, and prior to distribution, the first and second parts of the receptacle or support that are thermally stable are placed at a high temperature of 121 ° C. or higher within 28 hours. Irradiate the first and second parts with a dose that provides an effective sterilization assurance level, either by heating over a period of time or with a radiation source selected from the group consisting of gamma, X-ray, and electron beam radiation. It is sterilized by doing.

A further embodiment is a method of dispensing or releasing and curing a composition as defined above, comprising the step of distributing to a desired position at the curing temperature during the curing time.

The components may be manually mixed and distributed. Alternatively, any form of distribution device may be used, eg, the construct uses a collaborative distribution device that distributes collaboratively, eg, with a double tube syringe, eg, with a double tube syringe. It may be distributed by operating each cylinder or by loading and operating each of its cassettes.

A further embodiment is an elastomer containing a cured composition as defined above.

Usage A further aspect is the method of distributing the constituents as defined above.
Optionally, a step of combining components A and B of a curable component as defined above, thereby initiating curing, and
Including the step of distributing the components to positions as defined above,
After a suitable period, optionally an elastomeric seal is formed.

A further aspect is the method of sealing the wound care dressing, which
Steps to cut the dressing to fit size or shape,
With the step of placing the dressing over the wound and the skin around it,
Optionally, a step of combining components A and B of a curable component as defined above, thereby initiating curing, and
Including the step of distributing the components to positions as defined above,
After an appropriate period, an optionally elastomeric seal is formed on the cut covering edge.

Preferably, the construct operates each barrel of a syringe, eg, a collaborative distribution device as defined above, eg, a double cylinder syringe, eg, a double cylinder syringe. Distributing by letting or loading and operating each of its cassettes, preferably the syringe incorporates an integral means of constituting the distributed sealant, eg, an integral spreader head.

Treatment method A further aspect is a method of sealing the dressing or treating the wound site of a subject or animal in need of treatment.
As defined above, the step of applying the dressing to the wound site with a dressing and exposing a portion of it as defined above.
Includes steps to distribute the construct as defined above.

Preferably, the method is
Backing layer and
With a transmission layer located below the backing layer,
With the steps of providing a wound dressing as defined above,
With the step of removing a portion of the wound dressing to create a major wound dressing with one or more exposed areas,
Steps to position the main wound dressing over the wound,
A step of sealing the main wound dressing against the skin surrounding the wound and further sealing one or more exposed areas of the main wound dressing.
Includes the step of applying negative pressure to the wound through the backing layer of the main wound dressing.

In some embodiments of the method, the step of removing a portion of the wound dressing comprises cutting the wound dressing across at least one of one or more crosslinked portions. At least a portion of the wound dressing may be provided with a notched nick that facilitates removal of a portion of the wound dressing. The dressing may include multiple openings in the backing layer covered with releasable tabs, and negative pressure may be applied to the backing layer through one of the openings. The dressing may include multiple openings in the backing layer covered with releasable tabs, and negative pressure may be applied to the backing layer through two or more of the openings.

A portion of the wound dressing may be removed to size the primary wound dressing so that it is located above the incised wound. A portion of the wound dressing may be removed to size the major wound dressing so that it is positioned over the elongated leg wound. A portion of the wound dressing may be removed to size the major wound dressing so that it is positioned above the arched incision wound.

In another embodiment, a method of treating a wound is provided and the method is:
A wound dressing configured in a vertical or roll shape with multiple isolated openings in the backing layer, each covered with a backing layer, a transmission layer below the backing layer, and a releasable tab. Steps to provide and
Optionally, with the step of unwinding a portion of the wound dressing from the roll,
A step in which a portion of the wound dressing is removed from the length or roll and the removed portion comprises at least one opening in a backing layer covered with a releasable tab.
Steps to position the removed portion of the wound dressing over the wound,
Includes a step of applying negative pressure through at least one opening in the backing layer after removing the releasable tab.

Preferably, the step of distributing the sealant construct is by a device as defined above.

Preferably, the dressing is adhered onto the wound site using at least an adhesive on the underside of the dressing, or at least on the underside of the dressing.

Preferably, the method further comprises adjusting the position of the dressing before the composition is dispensed.

Preferably, the sealant is dispensed after covering the wound site with a dressing.

Preferably, the wound dressing is adapted to contain negative pressure, and the method further comprises applying negative pressure to the wound site using a negative pressure source connected to the wound site.

Preferably, the step of applying negative pressure is performed before and after dispensing the sealant.

Preferably, the step of applying negative pressure is by a portable negative pressure source that communicates fluidly with the wound dressing located above the wound site.

Preferably, the method comprises monitoring the negative pressure transmitted in the wound against the negative pressure generated.

Preferably, the dressing is an integral attachment to a liquid-tight backing layer, a functional wound healing layer and a negative pressure source, preferably using it to negative pressure through or under the backing layer. Is a combined TNP therapy dressing that incorporates a portable and / or periodic negative pressure source that is applied to the wound site. Preferably, an aperture is created on or under the drape to connect the wound site to the negative pressure source.

The wound packing material may be positioned to partially or completely fill the wound site.

The step of providing the sealant may be by distributing the sealant construct as defined above by a method as defined above.

The method may include monitoring the negative pressure transmitted against the negative pressure generated. It may be used to provide feedback to the user while applying the dressing. Generally, the NP is monitored at the pump or at the end of the port.

Preferably, a dressing is applied, the NP source is activated, a warning indicating NP loss is detected, the dressing is rubbed to close any site with NP loss, and a sealant is applied to the cut edges. To apply.

In one advantage, the step of providing the sealant is to dispense the sealant construct, which is a fluid that forms a material that, when dispensed, can make a substantially liquidtight seal.

Preferably, the method comprises combining at least two prepolymers to form a sealant.

Preferably, the dressing is part of a portable NPWT system. The leachate is managed in a portable canister or in a dressing. Negative pressure sources may be portable or intermittently connected. Preferably, the skin contact layer is an adhesive silicone gel, another adhesive, or a combination of an adhesive silicone gel with another adhesive.

Portable synthetic TNP dressings are commercially available and include, among others, Prevena (KCI), NPD1000 NP wound Therapy System (Kalypto Medical Inc), PICO (Smith & Nephew), for example in the literature. It is described more extensively in PCT / GB2011 / 000629, which is incorporated herein by reference.

When applying negative pressure with a pump, the dressing, in some embodiments, was partially crushed and wrinkled as a result of exhausting some or all of the air beneath the dressing. May show appearance. In some embodiments, the pump may be configured to detect any leaks in the dressing, such as at the interface between the dressing and the skin surrounding the wound site. If a leak is found, the leak is preferably improved before continuing treatment.

Treatment of the wound site preferably continues until the wound reaches the desired healing level. In some embodiments, it may be desirable to replace the dressing after a certain period of time or when the dressing is filled with wound fluid. During such replacement, the pump may be held only when the dressing is being replaced.

A further aspect provides the use of constructs, kits, or devices as defined above for dressing wounds, preferably for negative pressure wound healing dressings as defined above. To do. Sealant constructs, kits, and devices, in addition to providing vacuum seals for TNP applications, for example in sealing medical dressings, for example in controlling the appearance of wound exudates or the ingress of air or infection. , May be useful.

Such use is selected from chronic wounds, acute wounds, traumatic wounds, subacute and dehiscence wounds, ulcers (such as decubitus ulcers or diabetic ulcers), intermediate layer burns and flaps and grafts. Including. These include open wounds, wet wounds, granulation wounds, surgical wounds such as those by incision of the ulcer, and cancerous tissue such as perianal and perianal wounds. For ideal healing of such wounds, the wound should be closed on itself and prevent fluid from accumulating, while at the same time the tissue around the wound gradually contracts and the wound becomes It should be possible to shrink. Therefore, the wound filling material in NPWT functions as a kind of "stent" that supports the wound and keeps it open.

Sealant constructs, kits, or devices are particularly suitable for use in clean, sterile, or sterile applications. Preferably, the construct, kit, or device is sterilized as known in the art or as defined above and packaged within the barrier means. An additional barrier means provides a barrier against infection, whereby the component, kit, or device is a double packaged item, thereby removing the first layer of sterile sealed packaging. It makes it possible to expose receptacles or supports, adhesive strips, etc., such as cartridges for syringes or built into them, which are completely sterile inside and outside, to facilitate entry into a sterile environment. .. Components that omit additional barrier means will include a non-sterile outer surface of the receptacle or support and associated barrier means. If it is not possible to sterilize a component using standard conditions for medical devices as described above, it may not be possible to bring such component into a sterile field.

Sealants for medical dressings may be applied by any known or novel method. WO 00/74738 (Guyuron) discloses the use of silicone-based RTV-2 constructs to seal wounds, i.e. to minimize potential tubing. Therefore, the sealant may be used appropriately by pouring it over the wound and surrounding skin to allow it to harden.

A further aspect provides medical use of a kit, sealant, or device as defined above. The embodiment has one or more of the following advantages:
It becomes possible to easily seal the cut covering edge.
A seal around a three-dimensional dressing that follows complex body contours, improving the ability to remove or reduce leaks.
Custom sized, shaped, contoured and articulated dressing seals.
A dressing seal whose boundaries fit into the geometry of the body with a tight outer radius or otherwise deform to a high level.
Seals for systems where the covering material is significantly moved (eg, neck, shoulders, armpits, elbows, forearms, wrists, hands, groin, knees, ankles, heels, feet).

A number of specific embodiments suitable for conventional advanced wound dressings, conventional NPWT drapes / dressings, or PICO ™, and sealants as defined above are provided below. However, the overall references below should not be construed as limiting to the particular drawing or embodiment intended for illustration, but rather the ones described above to avoid improper duplication. Such explanations may be present in the sections below that are equivalent or more relevant to and are equally related to those described above.

FIG. 1 shows an embodiment of a TNP wound healing system 100 comprising a wound dressing 110 combined with a pump 150. As mentioned above, the wound dressing 110 can be any wound dressing disclosed herein, including but not limited to embodiments of the dressing, or any number disclosed herein. Can have any combination of features in the embodiment of the wound dressing. Here, the dressing 110 may be located above the wound as described above, and then the conduit 130 may be connected to the port 120, but in some embodiments the dressing 110 may be located on the port 120. It may include at least a portion of a conduit 130 pre-mounted on the. Preferably, the dressing 110 is provided as a single article in which all wound dressings (including port 120) are pre-attached and integrated into a single unit. The wound dressing 110 may then be connected to a negative pressure source such as a pump 150 via a conduit 130. The pump 150 can be miniaturized and portable, but larger conventional pumps may also be used with the dressing 110. In some embodiments, the pump 150 may be mounted on or adjacent to the dressing 110. A connector 140 may also be provided to allow the conduit 130 leading to the wound dressing 110 to be disconnected from the pump, which may be useful, for example, during the replacement of the dressing.

2A-2D show the use of one embodiment of the TNP wound healing system used to treat a patient's wound site. FIG. 2A shows the wound site 200, which has been cleaned and ready to be treated. Here, the healthy skin surrounding the wound site 200 is preferably cleaned and excess hair is removed or shaved. Wound site 200 is also irrigated with sterile saline as needed. Optionally, a skin protectant may be applied to the skin surrounding the wound site 200. If desired, a wound packing material such as foam or gauze may be placed at the wound site 200. This may be preferable when the wound site 200 is a deeper wound.

After the skin surrounding the wound site 200 has dried, and then with reference to FIG. 2B, the wound dressing 110 may be positioned and placed on the wound site 200. Preferably, the wound dressing 110 is placed with the wound contact layer 2102 on and / or in contact with the wound site 200. In some embodiments, an adhesive layer, which may optionally be protected by any stripping layer that is removed prior to placing the wound dressing 110 on the wound site 200, under the wound contact layer 2102. Provided on surface 2101. Preferably, the dressing 110 is positioned such that the port 2150 is in an elevated position with respect to the rest of the dressing 110 to prevent fluid from accumulating around the port. In some embodiments, the dressing 110 is positioned such that the port 2150 does not directly overlap the wound and is at or above the wound. The edges of the dressing 110 are preferably smoothed to avoid creases or creases to help ensure a seal suitable for TNP.

Next, referring to FIG. 2C, the dressing 110 is connected to the pump 150. The pump 150 is configured to apply negative pressure to the wound site via the dressing 110 and generally through the conduit. In some embodiments, and as described above in FIG. 1, a connector may be used to join the conduit from the dressing 110 to the pump 150. When applying negative pressure with the pump 150, the dressing 110, in some embodiments, is partially crushed as a result of exhausting some or all of the air beneath the dressing 110. May show a selfish appearance. In some embodiments, the pump 150 may also be configured to detect any leaks in the dressing 110, such as at the interface between the dressing 110 and the skin surrounding the wound site 200. Good. If a leak is found, the leak is preferably improved before continuing treatment.

Moving on to FIG. 2D, additional fixing strips 210 may also be mounted around the edges of the dressing 110. Such a fixation strip 210 may be advantageous in some situations to provide an additional seal in contact with the patient's skin surrounding the wound site 200. For example, the fixation strip 210 may provide an additional seal when the patient is more dynamic. In some cases, the fixed strip 210 may be used prior to running the pump 150, especially if the dressing 110 is placed over a hard-to-reach or hard-to-contour.

Treatment of the wound site 200 is preferably continued until the wound reaches the desired healing level. In some embodiments, it may be desirable to replace the dressing 110 after a certain period of time or when the dressing is filled with wound fluid. During such replacement, the pump 150 may be held only when the dressing 110 is being replaced.

3A-3C show cross sections of the wound dressing 2100, similar to the wound dressing of FIG. 1 according to one embodiment of the present disclosure. A top view of the wound dressing 2100 is shown in FIG. 1, and lines A-A show the location of the cross section shown in FIGS. 3A and 3B. The wound dressing 2100, or any number of wound dressings disclosed herein, or any number of wound dressings disclosed herein, including, but not limited to, the wound dressing 110. It can be any combination of features in the embodiment and can be located above the wound site to be treated. The dressing 2100 may be placed to form a sealed cavity over the wound site. In a preferred embodiment, the dressing 2100 comprises a backing layer 2140 and a wound contact layer 2102 to which it is attached, both of which will be described in more detail below. These two layers 2140, 2102 are preferably joined or sealed together to define an interior space or chamber. This interior space or chamber may be adapted to distribute or transmit negative pressure, store wound exudates and other fluids removed from the wound, and perform other functions described in more detail below. , May have additional structures. Examples of such a structure, which will be described later, include a transmission layer 2105 and an absorbent layer 2110.

As shown in FIGS. 3A-3C, the underside surface 2101 of the wound dressing 2100 may include any wound contact layer 2102. The wound contact layer 2102 is a polyurethane layer or polyethylene that has been perforated by, for example, a hot pin process, a laser ablation process, an ultrasonic process, or some other method, or otherwise permeable to liquids and gases. It can be a layer, or other flexible layer. The wound contact layer 2102 has a lower surface 2101 and an upper surface 2103. The perforation 2104 preferably comprises a through hole in the wound contact layer 2102 that allows fluid to flow through the layer 2102. The wound contact layer 2102 helps prevent internal growth of tissue into other materials of the wound dressing. Preferably, the perforation is small enough to meet this requirement, while it is still possible for fluid to flow through it. For example, perforations formed as slits or holes with a size of 0.025 mm to 1.2 mm are small enough to help prevent internal growth of tissue into the wound dressing, while wound exudates are on the dressing. It is still considered to be possible to influx. In some configurations, the wound contact layer 2102 may help maintain the integrity of the entire dressing 2100 and may also create an airtight seal around the absorbent pad to maintain negative pressure in the wound. ..

Some embodiments of Wound Contact Layer 2102 may also act as carriers for any lower and upper adhesive layers (not shown). For example, a lower pressure sensitive adhesive may be provided on the lower surface 2101 of the wound dressing 2100, or a pressure sensitive adhesive layer may be provided on the upper surface 2103 of the wound contact layer. Good. A pressure sensitive adhesive, which may be a silicone, hot melt, hydrocolloid, or acrylic adhesive, or other such adhesive, may be formed on both sides of the wound contact layer, or optionally of the wound contact layer. It may or may not be formed on one selected surface. If a low pressure pressure sensitive adhesive layer is utilized, it may be useful to adhere the wound dressing 2100 to the skin around the wound site. In some embodiments, the wound contact layer may include a perforated polyurethane film. A silicone pressure sensitive adhesive may be provided on the lower surface of the film and an acrylic pressure sensitive adhesive may be provided on the upper surface, which helps the dressing maintain its integrity. May be good. In some embodiments, the polyurethane film layer may have an adhesive layer on both its upper and lower surfaces, or all three layers may be perforated together.

The porous material layer 2105 can be located above the wound contact layer 2102. This porous layer, or transmission layer 2105, allows fluids, including liquids and gases, to be transmitted away from the wound site and into the upper layer of the wound dressing. In particular, the transmission layer 2105 preferably ensures that an open air channel that conveys negative pressure can be maintained over the wound area, even when the absorbent layer is absorbing a significant amount of exudate. Layer 2105 should preferably remain open under the general pressure that would be applied during negative pressure wound therapy as described above, thereby equalizing the entire wound site negative pressure. To experience. Layer 2105 may be made of material with three-dimensional structure. For example, knitted or woven spacer fabrics (eg Baltex 7970 weft polyester) or non-woven fabrics can be used.

The absorbent material layer 2110 is provided on top of the transfer layer 2105. Absorbent materials, including natural or synthetic materials of foam or non-woven fabric, and optionally including superabsorbent materials, form a reservoir of fluid, especially liquid, removed from the wound site. In some embodiments, layer 2100 may also assist in attracting fluid to backing layer 2140.

With reference to FIGS. 3A-3C, the masking or shielding layer 2107 can be located below at least a portion of the backing layer 2140. In some embodiments, the shielding layer 2107 has the same characteristics, materials, or the same features as any of the other embodiments of the shielding layer disclosed herein, including, but not limited to, having any viewing window or hole. It can have any of the other details. In addition, the shielding layer 2107 can be positioned adjacent to the backing layer or adjacent to any other coating layer desired. In some embodiments, the shielding layer 2107 can be adhered to or integrally formed with the backing layer. Preferably, the shielding layer 2107 is configured to have about the same size and shape for overlaying on the absorbent layer 2110. Therefore, in these embodiments, the shielding layer 2107 will have a smaller area than the backing layer 2140.

The material of the absorbent layer 2110 also prevents the liquid collected in the wound dressing 2100 from freely flowing through the dressing, preferably to contain any liquid collected in the absorbent layer 2110. It works. The absorbent layer 2110 also helps distribute the fluid throughout the layer via capillarity so that the fluid is drawn from the wound site and stored throughout the absorbent layer. This helps prevent agglutination within the range of the absorbent layer. The capacity of the absorbent material should be sufficient to control the exudate flow of the wound when negative pressure is applied. Since the absorbent layer experiences negative pressure during use, the material of the absorbent layer is selected to absorb the liquid under such circumstances. There are many materials that can absorb liquids under negative pressure, such as super-absorbent materials. The absorbent layer 2110 may generally be made from ALLEVYN ™ foam, Freudenberg 114-224-4, and / or Chem-Posite ™ 11C-450. In some embodiments, the absorbent layer 2110 may include synthetics containing superabsorbent powders, fibrous materials such as cellulose, and synthetics containing bound fibers. In a preferred embodiment, the compound is an air-laid heat-bonded compound.

An orifice 2145 is preferably provided on the backing layer 2140 so that negative pressure can be applied to the covering material 2100. The suction port 2150 is preferably mounted or sealed on top of the backing layer 2140 over an orifice 2145 formed in the covering material 2100 to transfer negative pressure through the orifice 2145. The long tube 2220 may be coupled to the suction port 2150 at the first end and to the pump unit (not shown) at the second end to allow fluid to be pumped out of the dressing. The port may be adhered and sealed to the backing layer 2140 using an adhesive such as acrylic, cyanoacrylate, epoxy, UV curable or hot melt adhesive. Port 2150 is made of a soft polymer, eg polyethylene, polyvinyl chloride, silicone, or polyurethane with a hardness of 30-90 on the Shore A scale. In some embodiments, the port 2150 may be made from a soft or shape compatible material, eg, using embodiments described below in FIGS. 3A-3B.

Preferably, the absorbent layer 2110 and the shielding layer 2107 include at least one through hole 2146 located underneath the port 2150 so as to overlap. Through hole 2146, which is shown here as being larger than the hole through the shielding layer 2107 and backing layer 2140, may be larger or smaller in some embodiments. Of course, the holes through these various layers 2107, 2140, and 2110 may be of different sizes relative to each other. A single through hole can be used to create an overlapping opening under port 2150, as shown in FIGS. 3A-3C. Alternatively, it will be appreciated that multiple openings can be used instead. In addition, if more than one port is utilized in accordance with certain embodiments of the present disclosure, one or more openings may be made in the absorption and shielding layers aligned with the respective ports. .. Although not required for certain embodiments of the present disclosure, the use of through holes in the superabsorbent layer provides a fluid flow path that remains unobstructed, especially when the absorbent layer 2100 is nearly saturated. Will be done.

The aperture or through hole 2146 is preferably provided to the absorbent layer 2110 and the shielding layer 2107 below the orifice 2145 so that the orifice is directly connected to the transmission layer 2105. This allows the negative pressure applied to port 2153 to be transmitted to the transfer layer 2105 without passing through the absorbent layer 2110. This ensures that the negative pressure applied to the wound site is not impeded by the absorbent layer as it absorbs the wound exudate. In other embodiments, the absorber layer 2110 and / or the shielding layer 2107 may not be provided with apertures, or may be provided with multiple apertures that overlap under an orifice 2145.

The backing layer 2140 is preferably gas impermeable but breathable and can extend across the width of the wound dressing 2100. The backing layer 2140, which may be, for example, a polyurethane film (eg, Elastollan SP9109) or a hydrocolloid film, has a pressure sensitive adhesive on one side, is gas impermeable, so this layer covers the wound and the wound. The dressing acts to seal the wound cavity located above it. In this way, an effective chamber is created between the backing layer 2140 and the wound site, where negative pressure can be established. The backing layer 2140 is preferably sealed against the wound contact layer 2102 in the boundary area 2200 around the perimeter of the dressing to ensure that air is not drawn through the boundary area, for example by adhesive or welding techniques. .. The backing layer 2140 protects the wound from external bacterial contamination (bacterial barrier) and allows liquid to transfer from the wound exudate through the layer and evaporate from the outer surface of the film. The backing layer 2140 preferably comprises two layers of a polyurethane or hydrocolloid film and an adhesive pattern diffused over the film. The film is preferably made from a material that is moisture permeable and increases its water permeability when moistened.

The absorbent layer 2110 may have an area larger than that of the transfer layer 2105 so that the absorbent layer overlaps the edge of the transfer layer 2105, whereby the transfer layer contacts the backing layer 2140. It is guaranteed not to do so. This provides an external channel 2115 of the absorbent layer 2110 in direct contact with the wound contact layer 2102, which helps the exudate to be absorbed into the absorbent layer more quickly. In addition, this external channel 2115 ensures that no liquid can collect around the wound cavity, otherwise the liquid will seep through the seal around the perimeter of the dressing and leak. May lead to formation.

As shown in FIG. 3A, one embodiment of the wound dressing 2100 comprises an aperture 2146 of absorbent layer 2110 placed below port 2150. In use, for example, when negative pressure is applied to the dressing 2100, the wound-facing portion of port 150 may therefore contact the transmission layer 2105, resulting in the absorbent layer 2110 being in the wound fluid. It can help transfer negative pressure to the wound site, even when it is full. Some embodiments may have a backing layer 2140 that is at least partially adhered to the transmission layer 2105. In some embodiments, the aperture 2146 is at least 1-2 mm larger than the wound-facing portion of port 2150, ie, the diameter of the orifice 2145.

The liquid impermeable but gas permeable filter element 2130 is provided to act as a barrier to the liquid and to ensure that the liquid cannot leak from the wound dressing. The filter element may also act as a bacterial barrier. Generally, the pore size is 0.2 μm. Suitable materials for the filter material of filter element 2130 include 0.2 micron Gore ™, Versapore ™ 200R, and Donaldson ™ TX6628 made of PTFE stretched from the MMT range. Larger pore sizes can also be used, but they may require an auxiliary filter layer to ensure sufficient bacterial load containment. Although not essential, it is preferable to use an oil repellent filter membrane, eg, 1.0 micron MMT-332 before 0.2 micron MMT-323, as the wound fluid contains lipids. This prevents lipids from blocking the hydrophobic filter. The filter element can be attached or sealed to the backing layer 2140 above the port and / or orifice 2145. For example, the filter element 2130 may be molded into the port 2150, or using an adhesive such as, but not limited to, a UV curable adhesive, both above the backing layer 2140 and below the port 2150. It may be adhered to.

FIG. 3B shows an embodiment of a wound dressing 2100 comprising spacer elements 2152, 2153 in conjunction with ports 2150 and filters 2130. By adding such spacer elements 2152, 2153, the ports 2150 and filter 2130 may be supported so that they do not come into direct contact with the absorbent layer 2110 and / or the transmission layer 2105. The absorbent layer 2110 may also act as an additional spacer element that keeps the filter 2130 out of contact with the transmission layer 2105. Therefore, such a configuration may minimize contact between the filter 2130 in use and the transmission layer 2105 and the wound fluid. Compared to the embodiment shown in FIG. 3A, the aperture 2146 through the absorbent layer 2110 and the shielding layer 2107 does not necessarily have to be as large as or larger than the port 2150, and thus simply. As long as the absorbent layer 2110 is saturated with wound fluid, it is large enough to maintain an air path from the port to the transmission layer 2105.

Next, referring to FIG. 3C, which shares many of the elements shown in FIGS. 3A-3C, the embodiments shown here include a backing layer 2140, a masking layer 2107, and an absorbent layer 2110, which are All have cuts or openings made through them that communicate directly with the transmission layer 2105 to form an orifice 2145. The suction port 2150 is preferably placed above it and communicates with the orifice 2145.

In particular, for embodiments with a single port 2150 and through hole, it may be preferable that the port 2150 and through hole be located in eccentric positions as shown in FIGS. 3A-3C and 1. This position allows the dressing 2100 to be positioned on the patient by allowing the port 2150 to be lifted relative to the rest of the dressing 2100. Contact between the port 2150 and filter 2130 and the wound fluid can cause the filter 2130 to occlude prematurely and prevent negative pressure from being transmitted to the wound site, but when positioned as described above, the fuport 2150 and It is possible to prevent the filter 2130 from coming into contact with the wound fluid.

FIG. 4A shows an exploded view of the dressing 3400 used in negative pressure wound therapy. Although this figure shows a dressing having a particular shape, the structure of the layers can be applied to any of the embodiments described below, including FIGS. 5A-8, which are also referred to herein by reference. It can be applied to any of the shapes and configurations of the dressing described in the patent application to be incorporated. The dressing 3400 comprises a release layer 3480, a wound contact layer 3460, a transmission layer 3450, an acquisition partitioning layer 3440, an absorbent layer 3430, a shielding layer 3420, and a backing layer 3410. The dressing 3400 may be connected to a port. At least the wound contact layer 3460, the transmission layer 3450, the absorbent layer 3430, the shielding layer 3420, and the backing layer 3410 have the properties as described for the particular embodiments described above, such as the embodiments of FIGS. 3A-3C. Alternatively, it may have the property described later.

The dressing 3400 may include a wound contact layer 3460 that seals the dressing 3400 against the healthy skin of the patient surrounding the wound area. Specific embodiments of the wound contact layer may include three layers: a polyurethane film layer, a lower adhesive layer, and an upper adhesive layer. The upper adhesive layer may help maintain the integrity of the dressing 3400, and the lower adhesive layer seals the dressing 3400 against the patient's healthy skin around the wound site. It may be used for. As mentioned above, in some embodiments relating to FIGS. 3A-3C, some embodiments of the polyurethane film layer may be perforated. Some embodiments of the polyurethane film layer and the upper and lower adhesive layers may be perforated together after the adhesive layer has been applied to the polyurethane film. In some embodiments, the pressure sensitive adhesive, which may be a silicone, hot melt, hydrocolloid or acrylic adhesive, or other such adhesive, is on both sides of the wound contact layer, or on one side of any choice. May be formed in. In certain embodiments, the upper adhesive layer may contain an acrylic adhesive and the lower adhesive layer may contain a silicone adhesive. In other embodiments, no adhesive may be provided for the wound contact layer 3460. In some embodiments, the wound contact layer 3460 may be transparent or translucent. The film layer of the wound contact layer 3460 may define an outer periphery having a rectangle or square. The peeling layer 3480 may be removably attached to the underside of the wound contact layer 3460 to cover, for example, the lower adhesive layer, or may be peeled off using a flap 3481. Some embodiments of the release layer 3480 may have a plurality of flaps extending along the length of the layer 3480.

Some embodiments of the dressing 3400 may include a spacer or transmission layer 3450. The transmission layer 3450 may include a porous material or 3D fabric configured to allow fluid to pass through it and enter the upper layer of the dressing 3400 away from the wound site. In particular, the transmission layer 3450 can ensure that the absorbent layer 3430 can maintain an open air channel to transmit negative pressure over the wound area, even if it is absorbing a significant amount of exudate. it can. The transmission layer 3450 should remain open under the general pressure that would be applied during negative pressure wound therapy as described above, thereby experiencing negative pressure equalizing the entire wound site. To do.

Some embodiments of Transfer Layer 3450 may be made of material with three-dimensional structure. For example, knitted or woven spacer fabrics (eg Baltex 7970 weft polyester) or non-woven fabrics can be used. In some embodiments, the transmission layer 3450 can have a 3D polyester spacer fabric layer. This layer consists of an upper layer, which is 84/144 patterned woven polyester, a lower layer, which can be 100 denier flat polyester, and a knitted polyester viscose, cellulose, etc., formed sandwiched between the two layers. It can have a third layer, which is a region defined by the monofilament fibers of. In use, this difference between the number of filaments in the separated layers helps to pull the liquid away from the wound bed and into the central region of the dressing 3400, where it is trapped by the absorbent layer 3430, or itself. Can suck the liquid towards the cover layer 3410, where it evaporates. Other materials are available, examples of such materials are described in US Patent Publication No. 2011/0282309, which is incorporated herein by reference and forms part of this disclosure. However, the transmission layer 3450 may be optional, for example, in embodiments of the dressing 3400 comprising the acquisition distribution layer 3440, as described below.

Some embodiments may comprise a wicking or acquisition partitioning layer (ADL) 3440 that horizontally sucks a fluid such as a wound exudate as it is absorbed upward through a layer of dressing 3400. Lateral wicking of the fluid may allow maximization of fluid distribution through the absorbent layer 3430, even allowing the absorbent layer 3430 to reach its full capacity. Good. This may advantageously improve breathability and effective delivery of negative pressure to the wound site. Some embodiments of ADL 3440 may include viscose, polyester, polypropylene, cellulose, or some or all combinations thereof, and the material may be needle punched. Some embodiments of ADL 3440 may contain polyethylene in the range of 40-150 grams (gsm) per square meter.

The dressing 3400 may further include an absorbent or superabsorbent layer 3430. The absorbent layer can be made from ALLEVYN ™ foam, Freudenberg 114-224-4, and / or Chem-Posite ™ 11C-450, or any other suitable material. In some embodiments, the absorbent layer 3430 can be a layer of non-woven cellulose fibers having a superabsorbent material in the form of dispersed dry particles throughout. The use of cellulosic fibers introduces high speed wicking that helps to quickly and evenly distribute the liquid taken up by the dressing. The juxtaposition of multiple strands leads to a strong capillary action in the fibrous pad, which helps to distribute the liquid.

For example, some embodiments of absorbent layer 3430 may include a layered structure of an upper layer of non-woven cellulose fibers and a layered structure of superabsorbent particles (SAP) and a lower layer of cellulose fibers containing 40-80% SAP. .. In some embodiments, the absorbent layer 3430 may be an airlaid material. The heat-sealing fibers can optionally be used to help hold the pad structures together. Some embodiments may combine cellulose fibers and air-laid materials and may further include up to 60% SAP. Some embodiments may contain 60% SAP and 40% cellulose. Other embodiments of the absorbent layer are 60% to 90% (or about 60% to about 90%) cellulose matrix and 10% to 40% (or about 10% to about 40%) superabsorbent particles. And may be included. For example, the absorbent layer may have about 20% superabsorbent material and about 80% cellulose fibers. It will be appreciated that instead of or in addition to using superabsorbent particles, superabsorbent fibers can be utilized according to some embodiments of the invention. An example of a suitable material is the product Chem-Posite ™ available from Emerging Technologies Inc (ETI) in the United States.

The superabsorbent particles / fibers can be, for example, a sodium polyacrylate or carbomethoxycellulose material, or any material capable of absorbing a liquid that is several times the weight of itself. In some embodiments, the material is capable of absorbing 0.9% W / W saline solution, which is more than five times its own weight. In some embodiments, the material is capable of absorbing 0.9% W / W saline solution, which is more than 15 times its own weight. In some embodiments, the material is capable of absorbing 0.9% W / W saline solution, which weighs more than 20 times its own weight. Preferably, the material is capable of absorbing 0.9% W / W saline, etc., which is more than 30 times its own weight. The absorbent layer 3430 can have one or more through holes 3431 located so as to overlap under the suction port.

Some embodiments of the present disclosure optionally also use a masking or shielding layer 3420, which helps reduce the appearance of the dressing 3400 during use due to the absorption of a small amount of leachate. Good. The shielding layer 3420 may be a colored portion of the absorbent material or may be a separate layer covering the absorbent material. The shielding layer 3420 may be one of various colors such as blue, orange, yellow, green, or any color suitable for hiding the presence of wound exudates in the dressing 3400. .. For example, the blue shielding layer 3420 may be a light blue color similar to the light blue commonly used in materials for medical outerwear, surgical gowns, and drapes. Some embodiments of the shielding layer 3420 may include a polypropylene spunbond material. In addition, some embodiments of the shielding layer 3420 may include hydrophobic additives or coatings. Other embodiments may include 60, 70, or 80 gsm thin fibrous sheets.

The shielding layer may include at least one viewing window 3422 configured to allow a visual determination of the saturation level of the absorbent layer. At least one viewing window 3422 may include at least one aperture made through a shielding layer. At least one viewing window 3422 may include at least one colorless area of the shielding layer. Some embodiments of the shielding layer may include a plurality of viewing windows or an array of viewing windows.

The masking ability of the shield layer 3420 should preferably be merely partial so that the clinician can access the required information by observing the diffusion of exudates over the surface of the dressing. The shielding layer 3420, even partially, due to the material properties by which the wound exudate can slightly alter the appearance of the dressing, or due to the presence of at least one viewing window 3422 in the material that completely shields. Good. The partial masking properties of the shield layer 3420 allow skilled clinicians to recognize different colors of the dressing due to exudates, blood, by-products, etc. and visually assess and monitor the degree of diffusion throughout the dressing. Will be possible. However, the color of the dressing changes from its clean state to a state containing exudates with only a slight change, so that the patient is less likely to notice any aesthetic differences. Reducing or eliminating the visual indicators of wound exudates from the patient has a beneficial effect on the patient's health and tends to reduce stress, for example.

The shielding layer 3420 may have one or more holes that overlap under the suction port. Some embodiments may have a Maltese cloth 3421 or other shaped cutout that overlaps under the suction port, the diameter of the Maltese cloth 3421 being greater than the diameter of the port. This allows the clinician to easily assess the amount of wound exudate absorbed in the lower layer of the port.

The dressing 3400 may also include a backing layer, or cover layer 3410, that extends across the width of the wound dressing. The cover layer 3410 is gas impermeable but may be moisture permeable. In some embodiments, polyurethane film (eg, Elastollan SP9109) or any other suitable material may be used. For example, certain embodiments may include translucent or transparent 30gsm EU33 film. The cover layer 3410 may have a pressure sensitive adhesive on the underside, thereby creating an enclosure that is substantially sealed over the wound where negative pressure may be established. The cover layer can protect the wound from external contamination as a bacterial barrier and may allow liquids from the wound exudate to migrate through the layer and evaporate from the outer surface of the film.

The cover layer 3410 can have an orifice 3411 located so as to overlap under the suction port. Orifice 3411 may allow negative pressure to be transmitted to the wound enclosure through cover layer 3410. The port may be adhered and sealed to the cover film using an adhesive such as acrylic, cyanoacrylate, epoxy, UV curable, or hot melt adhesive. Some embodiments may have multiple ports for distributing the fluid or multiple orifices for mounting other negative pressure sources or other mechanisms.

FIG. 4B shows a cross-sectional view of the wound dressing 3400 showing an embodiment of the relative thickness of the layers of the dressing 3400. In some embodiments, the wound contact layer 3460 may be flat and the top film layer 3410 may be contoured over the inner layer of the dressing 3400. The spacer layer 3450 may, in some embodiments, be half the thickness of the acquisition distribution layer 3440. In some embodiments, the absorbent layer 3430 may be approximately 1.5 times thicker than the spacer layer 3450. The shielding layer 3420 may be about half the thickness of the spacer layer 3450.

FIG. 4C shows another embodiment of the wound dressing 3900, where the various layers are shown in exploded views. Although this figure shows a dressing having one particular shape, the structure of the layer is incorporated herein by reference to any of the embodiments specified below, including FIGS. 5A-8. It can be applied to any of the shapes and configurations of the dressing described in the patent application. The wound dressing may include a release layer 3980, a wound contact layer 3960, a transmission layer 3950, an acquisition distribution layer 3940, an adhesive layer 3970, an absorbent layer 3930, a shielding layer 3920, and a backing layer 3910. At least the wound contact layer 3960, the transmission layer 3950, the absorbent layer 3930, the shielding layer 3920, and the backing layer 3910 have the properties as described for the particular embodiments described above, such as the embodiments of FIGS. 3A-3C. Alternatively, it may have properties as described below.

The dressing 3900 may be connected to port 3990 as shown in Figure 4D (shown without release layer 3980). At least the backing layer 3910, the shielding layer 3920, the absorbent layer 3930, and the acquisition partitioning layer 3940 may have an opening that overlaps under the port 3990, and the port 3990 is a three-dimensional fabric that overlaps over the opening. It may include a 3997 and a filter element 3995. The absorbent layer 3930 may be configured to absorb and retain exudates from the patient's wound. The absorbent layer 3930 will preferably be constructed from a material that has good absorbency under negative pressure. The adhesive layer 3970 may join the upper surface of the acquisition distribution layer 3940 to the lower surface of the absorbent layer 3930. In some embodiments of the trimpable dressing 3900, the layers remain together when the edges of the dressing are cut, and the other layers are together so that the layers do not separate vertically at the cut. They may be combined to provide consistency for layer alignment when the dressing is cut at one or more sides.

Figures A1 through A4 show trimming of TNP dressings in various ways. In Figure A1, the cut line is a simple cut to expose the internal transmission layer, in Figure A2 the hole that receives the fixation device or finger is cut, and in Figure A3 the dressing is curved. It is cut to allow contouring to body parts, and in Figure A4, the dressing is articulated to cover a movable joint such as the knee, in this case a transmission layer. Is cut out, but a certain amount of boundary area 2200 is retained to help retain and seal the dressing at its edges.

Figures A5 to A6 show that a trimmed dressing is applied and the sealant is dispensed with syringe A at the exposed transmission layer portion. In FIG. A7, the sealant is distributed through syringe A to perforation B of backing layer 2140.

FIG. B1 details the means by which the sealant is distributed by syringe A. The syringe has a nozzle aperture that allows the sealant to be distributed within the structure of the transfer layer in this case, and in Figure B2, the height or thickness of the transfer layer and the proper relationship between the cross section of the syringe nozzle and the aperture. Is shown.

Figures C1 to C3 show various modes of partitioning sealant C, FIG. C1 distributes to the interior of the transmission layer 2105 as shown in Figure B1, and C2 and C2a are the transmission layer 2105 and the wound. Cross-linking to the exposed skin surrounding 200, C3 cross-linking the transmission layer 2105 and the exposed portion of the retention strip attached to the skin surrounding the wound before the dressing is applied. The dressing is shown in exposed portion 2105 with a backing layer or sheet and a transmission layer which is a spacer layer. The dressing may include one or more additional layers (not shown) as defined above in the exposed portion 2105. The main covering portion or module of the covering pad may include an additional layer (eg, an absorbent layer above the transmission layer) not shown. FIG. C1 shows an embodiment of the seal and distribution mode of component C. In this embodiment, syringe A, such as a static mixer, is positioned such that the nozzle penetrates into exposed portion 2105. The nozzle of syringe A has a cross-sectional area suitable for being received within the exposed portion 2105 of the transmission layer. Component C is distributed inside exposed portion 2105. The nozzles of syringe A are inserted so as to penetrate a short distance within the exposed portion 2105 at intervals along the exposed surface, whereby component C is internally distributed as a seal within the exposed portion 2105. .. The composition may flow laterally in one or both directions of distribution and forward and backward, to some extent in the first application, with less flow as the composition hardens or hardens. This may help provide a continuous lateral seal, which may increase the distribution interval along the surface of exposed portion 2105. The nozzle insertion distance within the exposed portion 2105 is such that the seal is confined in a short distance from the surface of the exposed portion, or the component C overflows slightly outside the exposed portion and on the surrounding surface such as the preparation or skin 200. It may be selected so that it can be.

The advantage of this embodiment is that the amount of component C required for distribution is minimized. This then allows the use of lower volume syringes or static mixer A. The back pressure faced during distribution from the static mixer increases with the volume of the mixer, which in turn leads to a decrease in viscosity that the syringe or static mixer A can distribute. In general, it is advantageous for this embodiment to deliver the component C with the highest possible viscosity to ensure that the component C is confined within the exposed portion 2105. An additional factor in the total back pressure or resistance faced during the distribution of component C is the nozzle opening of syringe A. In the case of this embodiment, it is desirable to distribute the component C from a nozzle with a small opening, which adds back pressure. The advantage of this embodiment, which allows the use of a relatively small volume syringe or mixer A, allows for greater freedom in operating a nozzle with a small opening.

Finally, the inventors have found that the seal produced by distributing the constituent C inside the exposed portion 2105 according to this embodiment is very effective. As mentioned above, the dressing should be trimmed so that the exposed area overlaps the intact skin around the wound and not over the wound itself. For coatings with an adhesive or adhesive wound contact layer, such as the silicone contact layer as described above, the wound contact layer adheres to the skin 200 around the wound and of the exposed portion 2105 and the distributed seal C. Seal the covering material around the skin 200. The wound contact layer is perforated or otherwise porous to allow fluid transfer to and from the wound bed, thereby placing component C on the skin in direct proximity to the internal seal. Can be shed. This can beneficially improve the seal between the wound contact layer and the skin 200. If it is not desirable to flush the construct against the skin 200 in direct proximity to the inner seal, the construct C is appropriately viscous enough to limit the flow, or the wound contact layer is It may be non-porous or non-permeable in the region close to the conceived exposed portion, eg, in the crosslinked or trimmable portion as defined above.

FIG. B1 may be considered to indicate that the component C is distributed to a dressing having a shielding layer, thereby shielding the distributed seal, for one purpose. In contrast, the distributed seals are shown below the backing layer or sheet in Figure C1. This involves distributing the component C to a coating material that does not have a shielding layer, or to a coating material that has one or more windows in the shielding layer in the crosslinked portion or one or more trimmable portions. It shows that the nozzle insertion distance within the 2105, the volume of component C to be distributed, and the lateral flow that allows to determine the appropriate distribution interval across the surface of the exposed portion 2105 can be visually controlled. .. In the absence of a shielding layer, it is preferred that the construct incorporates ADL as a transfer layer as defined above rather than a spacer layer that may pose a risk of penetrating the backing sheet.

FIG. C2a shows an extension of FIG. C2 showing the sealant on the top film. The parts are referenced using the same reference numbers as in Figure C2. We have an advantage of a further embodiment of the seal and distribution mode that component C is distributed to a backing layer or backing sheet adjacent to exposed portion 2105, whereby component C is exposed to exposed portion 2105. It was found that it was to flow across and cover the exposed part 2105 as a whole. In some cases, component C flows a short distance into the exposed portion 2105 or is pulled in a short distance within the exposed portion 2105. It is desirable to distribute or smooth the construct C at the outer circumference of the exposed portion 2105 close to the boundary region 2200 as shown in FIG. C2a, and further to slightly revert along the outer circumference (not shown). is there. This has the advantage that the component C is advanced a short distance at the outer periphery of the exposed portion 2105 to secure the overall seal C and to secure the seal C in place. As the component C hardens or hardens, the viscosity generally increases and the flow ceases, thereby retaining the component C at or in distribution position 2105, forming a valid seal C.

This further embodiment provides performance requirements for component C and the resulting seal, in addition to the performance requirements for the first embodiment of the seal and distribution mode. Specifically, composition C forms a continuous film distributed over the entire surface of the backing layer or sheet and crosslinks over the exposed portion of any additional layer and the exposed portion 2105 of the transmission layer to skin Needs to be crosslinked on surface 200. Therefore, component C must be sufficiently viscous and / or cohesive to form an intact film. Such a film may be thin, or, as shown in FIGS. C2, C2a, and C3, for example, from the depth and / or thickness of the backing sheet, a component in the dressing or its exposed portion 2105. It may be of appropriate depth and / or thickness, up to the depth and / or thickness of the layer. If such a film breaks or breaks before solidification or curing of component C, the seal will break. After solidification or curing of an intact film, the exposed nature of the seal and its ability to retain integrity across the interface between adjacent layers by being presented as a film. , Robustness requirements are added. These requirements tend to be greater for thin films. Preferably, therefore, the seal according to this further embodiment is characterized by tensile strength, permanent strain, and elongation at break, and optionally extensibility, to the extent defined above. In contrast, the seal produced by the first embodiment as described above in FIG. C1 is largely supported by the dressing fabric that encapsulates the seal C, thereby causing tensile strength, permanent strain, and fracture. The stretch requirement is significantly lower and is encapsulated in a less stretchable coating, and the stretch requirement is significantly lower than in the further embodiments of FIGS. C2 and C3.

Figure C2a illustrates the need for a seal of this embodiment that is effective from the backing layer surface across the exposed portion 2105. As will be apparent, the seal over the exposed portion alone is vulnerable to breakage at the interface between the backing sheet and the exposed portion and any intervening layer.

The additional embodiments shown by FIGS. C2-C3 tend to be more effective when adapted in relation to a dressing that does not contain additional layers as defined above, thereby adding one or more. Good resistance to strain introduced by separation at the interface between layers and transfer layers. If one or more additional layers are present, they may be beneficially fixed to each other and to the transmission layer at their interface by puncture, suturing, and other means as known in the art. Good.

Further embodiments of FIGS. 2 and 3 further require that the seal C have a low profile and / or a compressibility higher than or equal to that of the covering material surrounding it. This is an advantage in minimizing discomfort to the wearer due to the protruding ridges on the exposed portion 2105 of the dressing.

In FIGS. C4 and C5, syringe A is shown which distributes the construct C to the exposed portion 2105 of the dressing transmission layer having the boundary region 2200. FIG. C6 shows a syringe A with a moderate spread of nozzle heads that distributes component C to the contoured exposed portion 2105 of the transmission layer. In Figure C7, a spreader tip combined with multiple nozzles that is shape compatible to distribute to the exposed area with contours and / or to the exposed area with blocked access. The nozzle head of syringe A with is shown. In Figure C8, the virtual cone shows the maximum dispenser A dimension that allows the shallow angle of incidence of the exposed portion 2105 with respect to the skin 200.

Figures C4 and C5 use a syringe or static mixer with a combination of a spreader tip and multiple nozzles as defined above (the spreader has multiple protruding apertures), the configuration of Figure C1. The distribution of component C according to the first embodiment of the seal and distribution mode of C is shown. The parts are referenced using the same reference numbers as in Figure C1. A dispenser (A) with a nozzle head with five nozzles with a small nozzle cross section is shown that delivers the sealant to an internal portion within the exposed portion 2105 of the transmission layer. The spread of the nozzle head matches the width of the cross-linked portion shown to allow distribution with a single insertion. Figure C4 shows that in the context of a relatively large dressing, component C is internally distributed to the internal portion of the exposed portion 2105 of the crosslinked portion. The main covering portion or module of the covering pad may include an additional layer (eg, an absorbent layer above the transmission layer) not shown. FIG. C5 shows distribution to the inner portion of the exposed portion 2105 of the crosslinked portion, for example, in the context of a dressing of any shape or configuration as defined above. This embodiment of the dispenser for the components and the mode of distributing the components reduces the load and requirements on accuracy on the operator's side, improves the mechanical accuracy of distribution and continuous seal formation. Benefit from. Also, the back pressure in the syringe may be slightly reduced to allow the use of more viscous constructs. Substantial boundary area 2200 is shown, which contributes to the integrity of the seal.

FIG. C6 shows a multi-nozzle head syringe A in which the full width or spread of the head is reasonably maintained to allow distribution of the transmission layer on a curve, eg, on the contours of the body, into the exposed portion 2105.

Figure C7 is flexible in two positions, facilitating distribution within the exposed portion 2105 of the transmission layer on the contour of the body, eg, and / or into position 2105 with closed access An alternative multi-nozzle head syringe A that is sex or deformable is shown. There is a flexible arm or restraint means (shown in gray) where four nozzles emerge from the arm. It is joined to the main body (with an integral static mixer) via four flexible tubes (also shown in gray).

The end of the drawing shows the nozzle end and the flexible arm showing how the arm can be bent to fit the arc. The tube may be similarly bent (not shown) to accommodate the production of angled nozzles, which beneficially increases the angle of incidence for distribution.

Flexible arms are generally not elastic, i.e., retain the shape given for distribution until they are bent back to their original shape or different form. The flexible arm can be made of a deformable polymer or putty, etc., or can be a mechanically flexible or deformable arm (ie http://snakeclamp.com/ or http. //joby.com/gorillapod).

Figure C8 shows a virtual cone containing Dispenser A. This can advantageously be considered in the design of dispenser A, which allows a shallow angle of incidence on the skin 200 so that the nozzle can be inserted into the exposed portion 2105 of the dressing transfer layer adhered to the patient 200. , Indicates the maximum dimensions.

5A and 5B show various embodiments of the wound dressing 500 that may be trimmed at the bridge portion 530. The dressing 500 is separated from the backing layer 510 and the absorbent layer and / or transmission layer formed on the main portion 520 by a gap 560 and connected by a bridge portion 530 to the port It may be equipped with a 550. In some embodiments, the main portion 520, additional portion 540, and bridge portion 530 include at least one transmission layer as described above between any wound contact layer and backing layer 510. In any or all of these compartments, the dressing 500 may further comprise any absorbent material as described above, located between the backing layer 510 and the transmission layer. In some embodiments, the absorbent layer may have a footprint similar to the transmission layer. In other embodiments, the absorbent layer may be located at the main portion 520 and at least one additional portion 540, but the absorbent layer may not be included at the bridge portion 530. As shown, the dressing has an elongated rectangular shape, but other shapes are conceivable. Since the absorbent layer preferably has a smaller footprint than the backing layer, the absorbent layer is completely surrounded by the backing layer. In some embodiments, it will be appreciated that the absorbent layer is an integral layer of material that extends across the main portion 520, additional portion 540, and bridge portion 530. Some embodiments may be manufactured without the port 550 and may include at least one range for mounting the port. For example, the port 550 may simply be a hole in the backing layer for mounting individual port members.

The dressing 500 may also include other layers as described above with respect to FIGS. 3A-4B. For example, the dressing 500 may include a wound contact layer that may be sealed to the backing layer 510, thereby creating an enclosed chamber for the absorbent layer and / or the transmission layer within the dressing. Will be done. The wound contact layer and backing layer may be sealed along the perimeter at a specific distance from the edge of the sealed perimeter to the edge of the absorbent layer. The wound contact layer and backing layer may also be sealed to each other through part or all of the range of the gap 560 between the inner layers.

The transfer or wicking layer may be provided to transmit negative pressure throughout the dressing and to pull the wound exudate away from the wound site and pull it into the upper layer of the dressing 500, as described above. Some embodiments of the transmission layer may include an acquisition distribution layer as described above with respect to FIG. 4A for lateral transmission of fluids such as wound exudates. In some embodiments, both the wicking layer and the acquisition partition layer may be used. The use of one or more of these layers may advantageously maintain the transfer of fluid through a narrow portion of the dressing, such as a bridge portion, which is partially under negative pressure. Alternatively, it may be kept from being completely crushed.

As shown in FIG. 5B, the absorbent layer and / or transmission layer may include a main portion 520 and a plurality of additional portions 540. The additional portion may be smaller than or the same size as the main portion 550. For example, when measured along the longitudinal length of the rectangular dressing, the length of the additional portion may be shorter than the length of the main portion, and each additional portion may have the same length. As shown, the main portion 520 is connected to the first additional portion 540 by one bridge portion 530 aligned along the central longitudinal axis of the covering material 500, and each additional portion is a similar bridge. Connects to the next additional part. The bridge portion may also be located off the central axis in FIGS. 5A and 5B, eg, on the side of the covering. In other embodiments, multiple bridges may be used to connect the parts of the dressing. For example, in one embodiment, two bridges may be used to connect the adjacent portions, the bridge being located at the side edge of the adjacent portion next to the sealed outer circumference. In another embodiment, two bridges, each located at a distance from the side edges of adjacent portions, may be used.

In some embodiments, the main portion 520 may have a pre-calculated minimum length, and some or all of the additional portion 540 may have a dressing for various lengths above the minimum length. It may have a length that can be removed for custom sizing. The main part length may be longer than the additional part length, or the main part may have the same length as the additional part. Such embodiments may be advantageous for long incisions, such as leg incisions made for venous collection. In one embodiment, the main portion 520 may be the minimum incision length or the minimum leg length, and the additional portion 540 may be included in the dressing to achieve a maximum incision length or a length less than or equal to the maximum leg length. Good. In use, the dressing may be trimmed according to the patient's incision length or leg length across the bridge portion, for example with a cutting line 570 described below. In some embodiments, additional ports or port attachment sites may be located in some or all of the additional parts to maintain a substantially even level of negative pressure throughout the relatively long dressing. Good.

The bridge portion 530 of FIGS. 5A and 5B creates a continuous pathway for delivering negative pressure over multiple sections of the dressing. The bridge portion 530 may have a width of less than 1/8, 1/4, or 1/3 of the width of the absorbent material and / or adjacent portion of the transfer layer. Wider bridge sections allow greater transmission of fluids such as negative pressure and wound exudates, while narrower bridge sections are advantageous for sealing dressings trimmed at bridge sections. Is. In addition, patient comfort may be improved if the bridge portion 530 is wide enough to cover the wound or incision. The dressing embodiments described herein may be balanced between these factors according to various objectives and / or considerations, and thus the width of the bridge portion 530 may vary. In some embodiments, the bridge portion 530 may be about 15 mm wide, while in other embodiments it is 10 mm to 20 mm (or about 10 mm to about 20 mm) wide, or thinner or thicker. May be good. In embodiments where a plurality of bridge portions are used, the bridge portions may all have a uniform width or may have different widths. In some embodiments, the bridge portion 530 may include a wound contact layer, a transmission layer (which may be one or both of the wicking layer and the acquisition partitioning layer described above with respect to FIG. 4A), and a backing layer. Good. Some embodiments of bridge portion 530 may further comprise an absorbent or superabsorbent layer. The layers within the bridge portion 530 may be continuous with the layers found in the dressing portion 520 or 540, or they may be discrete layers positioned side by side.

For coatings applied to non-planar surfaces, the bridge portion may also provide improved flexing of the coating, as it advantageously fits the non-planar surface. In addition, the bridge portion may enhance the lateral bending capacity of the dressing to cover a curved or arched incision. In some embodiments, the position and width of the bridge portion may be selected for both the connection of multiple trimmable portions and the flexibility of the dressing.

The dressing 500 may be trimmed at or across the bridge portion 530. The dressing may be trimmed at any portion, but for example, trimming the dressing at the bridge portion 530, perpendicular to the length of the dressing, results in a narrower exposed cross-sectional area and thus a tighter seal. It is simplified and therefore the area required for sealing after trimming can be reduced. In some embodiments, the gap 560 may have the same width as the distance from the sealed perimeter edge to the absorbent layer, whereby the dressing may have a trimming line 570 adjacent to the additional portion 540. When trimmed along, the sealed perimeter around one or more inner layers remains substantially unchanged. In some embodiments, this width may be about 2.5 cm, in other embodiments any width suitable for maintaining a seal between the backing layer and the wound contact layer. May be good. The dressing may be trimmed at positions other than the illustrated trimming line 570, which is included for illustration purposes only, eg, at the trimming line in the center of the bridge portion 530, or at a diagonal or curved trimming line. It will be understood that it is good.

In some embodiments, the absorbent layer and / or the other layer of the wound dressing may be pre-knurled for sizing. Other layers, such as the transmission layer or the acquisition distribution layer, may also be pre-knurled. The backing layer is uncut because the through holes can limit the ability of the backing layer to act as a bacterial barrier or sacrifice the ability of the dressing to maintain negative pressure. You may. Other embodiments may include a printed or indented pattern on some or all of the layers, indicating possible trimming lines.

After trimming, the dressing 500 may be sealed by an adhesive strip, by a piece of sealing drape, by another dressing, or by a sealant. In some embodiments, the retention strip may be applied at the interface between the covering edge and the skin. Retention strips may be applied to cover the boundaries of the trimmed dressing. In some embodiments, the retention strip may contain a pressure sensitive adhesive on the underside surface, and in other embodiments, it may be applied over the sealant. It will be appreciated that any other bonding method or mechanism may be used to seal the dressing. For example, the sealant may be applied using a device such as a syringe around the trimmed area to reseal the dressing chamber or to seal the dressing to the patient. Some embodiments of the dressing may be self-sealing.

5C and 5D show that a portion of the dressing was removed from the dressing of FIGS. 5A and 5C, thereby applying or applying the dressing to the wound site with sealant C distributed from syringe A. Shown is an exposed crosslinked portion of transmission layer 2105 that can be sealed later. In the case of Figure 5C, the dressing may simply be adapted to a particular ulcer size, and in the case of Figure 5D, the dressing is excellent for covering the wound after venous collection through the length of the subject's leg. It is adapted to.

FIG. 6 shows an embodiment of a trimmable wound dressing 600 comprising multiple portions or cells 620. The dressing 600 may include a sealed outer peripheral portion 610 of the backing layer and the wound contact layer, a plurality of cells 620, a plurality of bridges 630 connecting adjacent portions, and a port member 640. As mentioned above, the dressing 600 may be trimmed at the bridge portion and sealed along the trimming line. Each cell 620, along with any other layer, may include an absorbent material and / or a transfer layer as described above. The bridge portion 630 may include a wound contact layer, a transmission layer (which may be one or both of the wicking layer and the acquisition partitioning layer described above with respect to FIG. 4A), and a backing layer. Some embodiments of bridge portion 630 may further comprise an absorbent or superabsorbent layer. The layers within the bridge portion 630 may be continuous with the layers found in cell 620, or they may be discrete layers positioned side by side.

As shown, the covering material comprises a 4x4 array of cells 620. Other embodiments may include any suitable array of cells, or may be configured as N long roll rolls of cells. The cells may be connected by one or more narrow bridge portions 630 and separated by a gap 650. The backing layer and the wound contact layer may be sealed together over the entire gap. By trimming at the bridge portion 630, the integrity of the dressing may be maintained even when the dressing is significantly resized. For example, only one of the inner cells or inner cell groups is left, and the backing and wound contact layers are sealed over the entire area of the gap 650 to prevent the dressing layers from separating. It may be trimmed.

In some embodiments, the central cell of the dressing 600 may be removed. This may provide benefits, for example, when the dressing is used to coat a grafted or sutured skin flap. The dressing may be resized so that it is not substantially covered by the unsutured skin dressing. Therefore, the removed compartment will otherwise cover the flap's healthy skin. Covering healthy skin with a dressing poses potential problems, such as exposing the wound to bacteria on the surface of the flap and exposing the healthy skin of the flap to excess water. The dressing may also be appropriately resized to cover circular, curved, or other irregularly shaped sutures.

The port member 640 may be located on the corner cell of the dressing 600, as shown. However, in other embodiments, the ports may be located on different cells. Some embodiments may use multiple ports, each connected to a different cell. For example, a large dressing or a long roll dressing may have ports in the edge cells every N rows, such as every 4 or 5 rows. In some embodiments, one or more port attachment sites may be provided instead of the port member 640 shown.

FIG. 6II can remove a portion of the dressing from the dressing of FIG. 6 and thereby seal the dressing with the sealant C distributed from the syringe A before or after applying the dressing to the wound site. , Exposed multiple crosslinked portions of the transmission layer. It can be clearly seen that the use of cross-linked portions dramatically reduces the cross-sectional area of the transmission layer that must be sealed, thereby reducing the time to apply the dressing and the risk of leakage.

FIG. 7 shows an embodiment of a trimmable wound dressing 700 comprising a plurality of portions having a plurality of port attachment sites 760. Similar to the dressing 600 described above, the T-shaped dressing 700 has a backing layer and a wound contact layer with an outer circumference 710 sealed around a plurality of cells 720 containing an absorbent material, and / or a bridge portion. It has a transmission layer connected by a 730 and separated by a gap 740. The bridge portion 730 may include a wound contact layer, a transmission layer (which may be one or both of the wicking layer and the acquisition partitioning layer described above with respect to FIG. 4A), and a backing layer. Some embodiments of the bridge portion 730 may further comprise an absorbent or superabsorbent layer. The layers within the bridge portion 730 may be continuous with the layers found in cell 720, or they may be discrete layers positioned side by side. The wound contact layer and backing layer may also be sealed to each other through part or all of the range of gap 740. As mentioned above, the dressing 700 may be trimmed at the bridge portion and sealed along the trimming line. Although the dressing is shown as a T-shape, this is for illustration purposes only and the dressing may have various branched shapes. Each branch may include one or more cells connected by one or more bridge portions.

The dressing comprises a plurality of port attachment sites 760. Each mounting site 760 may be a hole in the backing layer or may be covered with a removable tab 760. The tabs may include a suitable backing material with an adhesive layer over a portion or all of the underside surface. Some embodiments may include a ring of adhesive sized to surround the hole 750 in the backing layer. The tab 760 may be removed so that the port may be attached to the backing layer over the hole 750 to transfer negative pressure into the dressing 700. In some embodiments, the port attachment may be fixed at only one port attachment site. In other embodiments, the port attachment may be anchored over multiple attachment sites as needed to transmit negative pressure throughout the covering. Some ports may have an adhesive on the underside surface for attachment to the dressing. Some embodiments of the dressing may include an adhesive layer for attaching the port.

FIG. 7II can remove a portion of the dressing from the dressing of FIG. 7 and thereby seal the dressing with sealant C distributed from syringe A before or after applying the dressing to the wound site. , The crosslinked portion of the transmission layer is exposed. This form of trimmable dressing has proved to be suitable when it is difficult to dress the wound, which may require some visual inspection and comparison with the wound composition, for example in the case of flap wounds. I understand.

FIG. 8 shows an embodiment of a trimmable wound dressing 800 with multiple port attachment sites 840. The dressing includes a backing layer and a wound contact layer having a sealed outer circumference 710, an absorbent layer 820, a spacer layer 830 below the absorbent layer, and a plurality of backing layers covered by tabs 850. Equipped with a hole 840. The spacer layer 830 may be one or both of the above-mentioned transmission layer and acquisition partition layer. In some embodiments, only one of the absorbent layer or the spacer layer is provided, the other may be optional.

The covering material 800 may be configured as a roll in which the port attachment site 840 is separated by a distance along the upper surface. In some embodiments, this distance may be uniform across all port attachment sites, and in other embodiments, the distance may vary. The dressing roll is custom sized by unwinding the length of the dressing, trimming the dressing, sealing the two sides, and attaching one or more ports to one or more port attachment sites. May be good. In some embodiments, the unused port attachment site 840 may remain sealed by the adhesive tab 850. In some embodiments, the spacer layer 830 and optionally the absorbent layer 820 are located between each port attachment site to facilitate sealing of the trimmed dressing, a bridge portion or multiple bridges. It may have a portion. It will be appreciated that any of the coatings described above may be configured as a trimpable roll in which the plurality of port attachment sites are rolled and spaced apart. For example, an elongated dressing configured as a roll may include narrower cross-linked portions separated along the length of the dressing between the port attachment sites, which facilitates trimming the dressing to the appropriate size. Good.

FIG. 8II can remove a portion of the dressing from the dressing of FIG. 8 and thereby seal the dressing before or after applying it to the wound site with sealant C distributed from syringe A. , Exposed multiple crosslinked portions of the transmission layer.

Such adaptable and resizable dressings may provide the advantage of reducing the inventory of dressings that need to be retained in hospitals or clinics. Rather than maintaining a large inventory of dressings of multiple shapes and sizes for any wound or incision site, the hospital or clinic can modify it to suit the needs of any patient, herein. You may only need one or more of the dressings described in. In addition, it may be advantageous in terms of manufacturing conditions to produce adaptable coatings.

Summary of Examples of Layered Materials Figures 9A and 9B may be used in any of the dressing embodiments described above, or in either the port or fluid connector of the embodiments described above. An embodiment of the material of the spacer layer, that is, the transmission layer is shown. The spacer or transfer material is preferably made of material with three-dimensional structure and may have upper and lower layers that include knitting patterns. For example, knitted or woven spacer fabrics (eg Baltex 7970 weft polyester) or non-woven fabrics can be used. The upper and lower fabric layers may include polyesters such as 84/144 patterned woven polyesters or flat denier polyesters. Of course, linear mass densities of other materials and fibers can be used. In some embodiments, the upper and lower fabric layers may have the same pattern and the same material, while in other embodiments they may have different patterns and / or different materials. The number of filaments of the yarn used to form the upper fabric layer to control the moisture flow across the transmission layer is greater than the number of filaments constituting the yarn used to form the lower fabric layer. You may. In particular, by increasing the number of filaments in the upper layer, that is, by making the upper layer from threads with more filaments than the threads used in the lower layer, the liquid is sucked up along the upper layer rather than the lower layer. Tend. FIG. 9A shows one possible knitting pattern for the upper or lower fabric layer.

As shown in the side view of FIG. 9B, there may be a plurality of filaments between the upper and lower fabric layers. The filament may include monofilament fibers or multi-strand fibers and may be knitted polyester viscose or cellulose. In some embodiments, most of the volume units of the filament may extend vertically (ie, perpendicular to the planes of the upper and lower layers), or substantially or entirely in the vertical direction. In another embodiment, 80% to 90% by volume (or about 80% to about 90% by volume) of the filament may extend vertically, or substantially or entirely vertically. .. In another embodiment, all or substantially all by volume of the filament may extend in the vertical direction or substantially or entirely in the vertical direction. In some embodiments, most of the filaments, 80% to 90% (or about 80% to about 90%) or more, or even all or substantially all of the filaments are upward and / from the lower fabric layer. Alternatively, it extends downward from the upper fabric layer, and in some embodiments, such filaments extend over a length of more than half the distance between the upper and lower fabric layers. In some embodiments, the majority of the filaments, 80% to 90% (or about 80% to about 90%) or more, or even all or substantially all of the filaments are parallel to the upper and lower fabric layers. In the direction perpendicular to the upper and lower fabric layers (vertical direction) than in the horizontal direction (horizontal direction), it extends over a longer distance. Such filament orientation may facilitate vertical wicking of the liquid through the spacer layer. In some embodiments, the ratio of the amount of fluid that is sucked up vertically across the spacer material to the amount of fluid that is sucked up laterally across the spacer material under negative pressure is 2: 1. It may be greater than or equal to, or about 2: 1 or greater, or in some embodiments, less than or equal to 10: 1 or greater, or greater than or equal to about 10: 1. Such filaments may also hold the upper and lower layers separated when exposed to compressive or negative pressure. Some embodiments of the spacer layer may have tensile strength that is substantially prevented from being avoided by the general force applied by human hands, thus realized in the form of a trimmable dressing. If so, it may be necessary to cut by other means such as cutting or slicing.

10A-10D are of acquisition partitioning layer (ADL) materials that may be used in any of the dressing embodiments described above and in any of the ports or fluid connectors described above. An embodiment is shown. It will be apparent to those skilled in the art of acquisition distribution layers that other ADL materials may be used to achieve similar effects.

FIG. 10A shows a backscattered scanning electron microscope (SEM) plan view of a sample portion of the gained partitioning layer material at 140x magnification. FIG. 10B shows a cross-sectional view of the SEM at a magnification of 250x. As shown in FIG. 10B, most of the fiber volume may extend horizontally (ie, parallel to the planes of the upper and lower surfaces of the material) or substantially or entirely horizontally. Good. In another embodiment, 80% to 90% (or about 80% to about 90%) or more of the fiber volume may extend horizontally or substantially or entirely horizontally. In another embodiment, all or substantially all of the fiber volume may extend horizontally, or substantially or entirely horizontally. In some embodiments, the majority of the fibers, 80% to 90% (or about 80% to about 90%) or more, or even all or substantially all of the fibers, are greater than the thickness of the ADL material. It extends to a distance (horizontal or lateral distance) perpendicular to the thickness of the ADL material. In some embodiments, the horizontal or lateral distance covered by such fibers is at least twice (or about twice), three times (or about three times), four times (or about four) the thickness of the ADL material. More than double), 5 times (or about 5 times) or more, or 10 times (or about 10 times) or more. Such fiber orientation may facilitate the lateral uptake of the fluid through the ADL material. This may allow fluids such as wound exudates to be more evenly distributed throughout the ADL material. In some embodiments, the ratio of the amount of fluid sucked up laterally across the ADL material to the amount of fluid sucked up vertically across the ADL material under negative pressure is greater than or equal to 2: 1 or about 2. 1 or more, or in some embodiments, 10: 1 or more, or 10: 1 or more.

FIG. 10C is a two-dimensional microscopic tomography cross-section of the compressed portion of a sample of ADL material that is approximately 9.2 mm long. FIG. 10D is a cross-sectional view of the compressed portion shown in FIG. 10C at a magnification of 130 times. Such compressions may occur in the material by applying pressure to the ADL material. Figures 10C and 10D further show the horizontal ADL fiber network.

11A and 11B show an embodiment of an absorbent material that may be used in any of the dressing embodiments described above. FIG. 11A shows a three-dimensional microscopic tomography cross-section of a sample of absorbent material showing a fiber composition interspersed with superabsorbent particles. Absorbent materials are, for example, those disclosed in U.S. Patent Publication No. 2012/308780, dated May 25, 2012, entitled "Absorbent Structure," which is incorporated herein by reference in its entirety. It may be either.

FIG. 11B is a schematic cross-sectional view of an embodiment of the absorbent material showing multiple layers within the absorbent material. The absorbent material may have a patterned layer 4210 on one side of the fiber net, which defines a bulk of the absorbent material and comprises layers 4220, 4240, and 4250. Superabsorbent particles 4230 may be dispersed throughout layers 4220, 4240, and 4250. The patterned layer 4210, also referred to as the "structural dispersion layer" in the above parts of the specification, may be configured to transmit the fluid laterally. Although shown as the bottom layer of the absorbent material, the patterned layer 4210 may be positioned as the top layer of the absorbent material in some embodiments, and in some embodiments the top of the absorbent material. It may be positioned as both the lower layer and the uppermost layer. The patterned layer 4210 may contain flat fibers with a width of 20 μm to 50 μm, or about 20 μm to about 50 μm. The patterned layer 4210 may contain one or two layers, or about one to about two layers of flat fibers, and the patterned layer 4210 may have an overall thickness of 0.04 mm, or about 0.04 mm. Good.

Bulks of absorbent material with layers 4220, 4240, and 4250 may have a thickness of 1.7 mm, or about 1.7 mm, or range from 0.5 mm to 5.0 mm, or about 0.5 mm to about 5.0 mm. May have a thickness of. The bulk of the absorbent material is a mixture of two fiber types arranged in a fibrous network, eg, cellulose fibers having a width of 20 μm to 50 μm, or about 20 μm to about 50 μm, and PE / PET described above for ADL materials. It may contain synthetic fibers. The superabsorbent particles 4230 may be irregularly shaped and vary in size, and may have a diameter of less than 1 mm, or about 1 mm. The superabsorbent particles 4230 may contain a sodium acrylate type material. A relatively small number of superabsorbent particles present on a portion of the top surface of the bulk of the absorbent material (the surface of layer 4250 opposite the patterned layer 4210), for example on the top surface having a thickness of about 0.1 mm. It may be.

Layer 4220 may be a liquid absorbing layer configured to pull liquid upwards through the material towards layers 4240 and 4250. Layer 4240 may be a storage layer configured to hold the absorbed liquid. Layer 4220 prevents (or substantially inhibits) the absorbed liquid from reversing downwards through the underlayer of the absorbent material (this phenomenon is commonly known as "back wetting"). In addition, it may be a liquid distribution layer configured to apply a "back suction" action to the liquid storage layer 4240.

The superabsorbent particles 4230 may be distributed primarily within the storage layer, may partially extend into the absorption layer 4220 and the liquid distribution layer 4250, or may be evenly (or substantially) throughout the layer. May be evenly distributed). Layers 4220, 4240, and 4250 may overlap with a portion of adjacent layers and may or may not be separable.

12A and 12B show an embodiment of a shielding layer material that may be used in any of the dressing embodiments described above. FIG. 12A shows a plan view of a shielding material showing a material with a fiber net having a repeating, regularly spaced cross-shaped diamond pattern. The diamond-shaped pattern may, in one embodiment, be 1.2 mm long x 1.0 mm wide and may have a thickness of about 0.04 mm, consisting of fibers that are denser with respect to the perimeter of the material. Good. The diamond-shaped pattern may increase the structural stability of the fiber mesh of the material, which serves, for example, as a "sticky" point. FIG. 12B shows a three-dimensional microscopic tomography perspective view of the compressed diamond pattern and surrounding uncompressed fibers.

Some embodiments of the shielding material may include a polypropylene spunbond material. In addition, some embodiments of the shielding material were designed to penetrate hydrophobic additives or coatings, such as the fibers of the shielding material, to make the material substantially waterproof and breathable. , Hydrophobic cleaning solution may be contained. Other embodiments may include 60, 70, or 80 gsm thin fiber sheets. The fibers of the shielding material may, in one embodiment, include a layer of polypropylene (PP) fibers having a smooth surface morphology, the PP fibers having a thickness of about 25 μm. In some embodiments, the shielding material may have a thickness of .045 mm or about .045 mm, or has a thickness in the range 0.02 mm to 0.5 mm, or about 0.02 mm to about 0.5 mm. You may.

FIG. 13 is an embodiment of an adhesive diffused over about 1 square centimeter of film material that may be used as a cover or backing layer in either the dressing embodiment described above or the fluid connector embodiment. Is shown. The adhesive on the film is coated with carbon powder to facilitate the diffusion of the adhesive. The adhesive may include, for example, an acrylate-based adhesive, such as a K5 adhesive, or may be placed in a cross pattern. In some embodiments, the adhesive may cover approximately 45.5% ± 1.3% of the film surface. The pattern or coverage of the adhesive may vary as long as the configuration is suitable for the desired moisture permeability.

I. Overview of additional cross-linked dressing embodiments Figure 14A (previously Figure 17A) shows that the number of layers present in the cross-linked portion 1620 of the coating is from the absorbent pad portion 1630 or auxiliary absorbent portion 1650 of the coating. The plan view of the trimming dressing 1600 is shown. FIG. 14B (previously FIG. 17B) shows a side view of the covering material 1600. Therefore, the total height of the dressing is reduced at the crosslinked portion 1620 relative to the absorbent pad portion. In some embodiments, the dressing can also be reduced in width at the crosslinked portion with respect to the absorbent pad portion. Covering material 1600 also includes port 1640 for delivering negative pressure.

The dressing 1600 includes a spacer layer 1662 in the absorbent pad portion 1630 and the auxiliary absorbent portion 1650. The ADL 1664 extends across the length of the dressing through the absorbent pad portion 1630, the auxiliary absorbent portion 1650, and the crosslinked portion 1620. ADL 1664 meets the test criteria specified above and is capable of transmitting negative pressure through the crosslinked portion 1620. In some implementations of the trimpable coating 1600, the ADL 1664 may be constructed from an ADL material that is easier to cut than the spacer material, or may be appropriately selected for the crosslinked portion 1620. In other embodiments, the spacer layer 1662 may extend across the length of the dressing in addition to or instead of ADL 1664.

In the absorbent pad portion 1630 and the auxiliary absorbent portion 1650, the coating material 1600 includes an absorbent layer 1666 and a masking layer 1668. In some embodiments, the masking layer 1668 may extend across the crosslinked portion 1620, providing a hole, window, perforation, or other visual indicator to indicate to the user where to cut the dressing. It may be included. For example, the perforations are arranged in a dashed or dotted line configuration along positions within the crosslinked portion 1620 to reveal the contrasting color of ADL 1664 below the masking layer 1668 and have potential for trimming the covering material 1600. The position may be indicated visually. This strategy can be extended to include design and symbol systems such as scissors symbols and / or dotted lines, or notches / chevrons on either side of the masking layer, lettering indicating the "cut here" position. it can. The inner layers 1662, 1664, 1666, 1668 are of the wound contact layer 1672 and the upper film layer 1674, which are sealed together around the outer circumference 1610, eg, around the outer circumference of about 2.5 cm in some embodiments. Positioned in between.

This layering increases flexibility at the cross-linking point while wearing the dressing, is easy to cut with scissors (or other means) while adapting and shaping the dressing to the wound site, and , Can provide the advantage of easy sealing of the cut portion. By reducing the height of the cross-linked portion, the gap that needs to be sealed is smaller. The cut or trimmed portion can be sealed using a sealant, a seal strip, a flexible adhesive drape, or other sealing means. In addition, the use of an upper layer, which is different from the crosslinked portion, for the absorbent pad portion provides a color-coded dressing, which allows the cutting position to be made apparent to the user. Such dressings can be trimmed according to specific patient needs and can be conveniently used for long incision wounds of varying length, eg, along with incisions made by abdominal wall plasty.

Then, with reference to FIG. 15 (previously FIG. 21), another embodiment of the trimpable dressing 2100 is shown. From bottom to top, the dressing includes any wound contact layer (not shown), a transmission layer and / or ADL above the wound contact layer, and multiple absorbable cells above the transmission layer and / or. May include a cover layer on top of the absorbent cell. As shown in FIG. 15, one embodiment of the dressing connects a boundary 2105, a nearly rectangular transmission layer 2110, a large number of absorbent cells 2115, ports 2120, and a dressing 2100 to a negative pressure source. Includes conduit 2125 and for. Boundary 2105 can include a cover layer as described above, which is, in one example, sealed against the healthy skin of the patient surrounding the wound, or a cover layer which is sealed against the wound contact layer as described above. Can include. This cover layer may extend over a plurality of absorbent cells 2115. Ports 2120 and conduits 2125 can be configured to transfer negative pressure from the negative pressure source to the covering material 2100 during use.

The transfer layer 2110 can extend across the entire central pad area and has adequate permeability to gas and liquid at minimum height and / or minimum width, any material or material described herein or. It can be its equivalent. A more comfortable pressure distribution over the patient's treatment site can be achieved by extending the transmission layer 2110 across the central pad area rather than simply locating it in the cross-linking area. Such pressure distribution can be considered both in terms of NPWT delivery and in terms of protecting brittle skin where swelling can occur at the pad edges (depending on the design of the dressing). Thus, the continuous transfer layer can, in some embodiments, minimize the number of pad edges (ie, use a continuous lower layer) to provide benefits for pressure distribution.

A large number of absorbent cells 2115 can be included on top of the transfer layer 2110 and can be any of the absorbent materials described herein, eg, with respect to FIGS. 3A-4D and 11A-11B. By cutting the dressing 2100 along the range of the transmission layer 2110 between adjacent cells 2115, the dressing 2100 can be adapted and sized to correspond to the shape of the patient's wound. The dressing 2100 can be sealed along the cut portion by one or more of resealing the cover layer and the wound contact layer through a sealant adhesive and sealing the strips of various embodiments.

Absorbent cells 2115 are shown as having a triangular shape, but may be circular, oval, square, rectangular, hexagonal, or other shaped cells. Further, the absorbent cell 2115 is shown as being a discrete portion of the absorbent material, but in other embodiments the absorbent cell 2115 can be connected by a crosslinked moiety.

II. Overview of Additional Layer Materials Figures 16A and 16B (formerly 22A and 22E) may be used in any of the coating material embodiments described above and in any of the port or fluid connector embodiments described above. Here is an example of a Libeltex DryWeb T28F that may be suitable for use as an Acquired Distributor Material (ADL) material that may be used in It will be apparent to those skilled in the art of acquisition partitioning layers, also known as "surge layers", that other ADL materials may be used to achieve a similar effect of laterally sucking fluid. Suitable ADL materials can allow full volume use. Such ADL layers may be composed of multiple fiber types and may be complex in structure and design.

FIG. 16A shows a backscattered scanning electron microscope (SEM) plan view of a sample portion of ADL material at 70x magnification. As shown by FIG. 16A, the ADL material sucks fluid laterally / horizontally through the ADL material, so it is at least partially horizontal (ie, parallel to the planes of the upper and lower surfaces of the material). ) Can contain a large number of non-woven fibers that are extended.

FIG. 16B shows an SEM cross section of the ADL material at 1550x magnification. In the illustrated embodiment, the ADL material may consist of a mixture of multiple fiber types. One may be a nearly cylindrical fiber. Another fiber may be a relatively flat fiber with a centrally located negative pressure space. Another fiber may be a multi-component fiber having at least one inner core fiber, in some embodiments three inner core fibers as shown in the sample shown, and an outer layer surrounding the inner core. ..

Figure 17A (formerly 23A), Figure 17B (23B), and Figure 17C (formerly 23D) show examples of Libeltex SlimCore TL4 that may be suitable for use as an acquisition partitioning layer material. FIG. 17A shows an SEM cross section of a sample portion of ADL material at 50x magnification. ADL materials can include upper layers 2305 and lower layers 2310 with different densities, bulkiness, and thickness. For example, the upper layer 2305 can include a denser, less bulky fibrous composition and, in some embodiments, can be about 730 μm thick. The lower layer 2310 can contain a lower density and bulky fibrous composition and can be about 1200 μm thick in some embodiments. FIG. 17B shows an SEM plan view of the sample portion of the upper layer 2305, which is denser at 70 times magnification, and FIG. 17C shows an SEM plan view of the sample portion of the lower layer 2310, which is bulkier at 70 times magnification. As shown by FIGS. 17A-17C, the upper and lower layers 2305 and 2310 of the ADL material suck fluid laterally / horizontally through the ADL material, so that it is at least partially horizontal (ie, above and below the material). It can contain different densities of numerous non-woven fibers that extend (parallel to the plane of the side surface).

As shown by FIGS. 17A-17C, the non-woven fibers of the various illustrated ADL materials should extend more horizontally than vertically to help draw fluid laterally through the material. Can be done. In some embodiments, most of the fiber volume may extend horizontally or substantially or entirely horizontally. In another embodiment, 80% to 90% (or about 80% to about 90%) or more of the fiber volume may extend horizontally, or substantially or entirely horizontally. In another embodiment, all or substantially all of the fiber volume may extend horizontally, or substantially or entirely horizontally. In some embodiments, 80% to 90% (or about 80% to about 90%) of the fibers, or even all or substantially all of the fibers, is the thickness of the ADL material longer than the thickness of the ADL material. It extends to a distance perpendicular to (horizontal or lateral distance). In some embodiments, the horizontal or lateral distance covered by such fibers is at least twice (or about twice), three times (or about three times), four times (or about four) the thickness of the ADL material. More than double), 5 times (or about 5 times) or more, or 10 times (or about 10 times) or more. Such fiber orientation may facilitate the lateral uptake of the fluid through the ADL material. This may allow fluids such as wound exudates to be more evenly distributed throughout the ADL material. In some embodiments, the ratio of the amount of fluid sucked up laterally across the ADL material to the amount of fluid sucked up vertically across the ADL material under negative pressure is greater than or equal to 2: 1 or about 2. 1 or more, or in some embodiments, 10: 1 or more, or about 10: 1 or more.

Features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are in any other aspect, embodiment, or embodiment described herein, unless non-conforming. It should be understood that it is applicable. All of the features disclosed herein (including any accompanying claims, summaries, and drawings), and / or all steps of any method or process disclosed herein are such features and / or Any combination may be combined, except for combinations in which at least some of the steps are mutually exclusive. The object of protection is not limited to the details in any of the above embodiments. Protected is any new of the features disclosed herein, including any accompanying claims, abstracts, and drawings, or any new combination thereof, or any disclosure herein. Any new method or process step, or any new combination thereof.

Although specific embodiments have been described, these embodiments are presented as examples only and are not intended to limit the scope of protection. In fact, the novel methods and systems disclosed herein may be embodied in various other forms. In addition, various omissions, substitutions, and changes may be made in the methods and forms of the system described herein. One of ordinary skill in the art will appreciate that in some embodiments, the actual steps taken in the illustrated and / or disclosed process may differ from those shown in the drawings. Depending on the embodiment, certain of the steps described above may be removed or others may be added. Moreover, the features and attributes of the particular embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure.

Although the present disclosure includes specific embodiments, examples, and applications, embodiments that do not provide all of the features and benefits described herein beyond those specifically disclosed. It will be appreciated by those skilled in the art to extend to other alternative embodiments and / or uses, including, and their obvious modifications and equivalents. Accordingly, the scope of this disclosure is not limited by the specific disclosure of preferred embodiments herein, but is defined by claims as presented herein or in the future. You may.

Throughout the description and claims herein, the terms "providing" and "including" and their variations mean "including but not limited to" other parts, additions, components. , Integers, or steps are not intended to be excluded (and they are not excluded). Throughout the description and claims herein, the singular includes the plural unless context requires the opposite. In particular, when indefinite articles are used, it should be understood that the plural and singular forms are conceived unless the context requires the opposite.

Features, integers, properties, compounds, chemical moieties, or groups described in connection with a particular aspect, embodiment, or example are any other aspect, embodiment described herein, unless non-conforming. It should be understood that it is applicable to the form or embodiment. All of the features disclosed herein (including any accompanying claims, summaries, and drawings), and / or all steps of any method or process disclosed herein are such features and / or Any combination may be combined, except for combinations in which at least some of the steps are mutually exclusive. The details of any of the embodiments described above should not be considered limiting unless expressly indicated. An embodiment is any novel of the features disclosed herein, including any accompanying claims, abstracts, and drawings, or any novel combination thereof, or any disclosure herein. It may be related to any new method or process step of the above, or any new combination thereof.

In this specification, either a period or a comma is used as the decimal point symbol.

The reader pays attention to all documents submitted at the same time as or prior to this specification in connection with this application and published with this specification, and all such documents. The contents are incorporated herein by reference.

(Examples) The following examples are given as non-limiting examples.
Constituents Commercially available RTV-2 Si constructs with two parts incorporating the literature values of the physical properties of i), ii), and iii) as defined above have a public literary value of the physical properties. It is available at.
P1 Cavi-Care ™ (Trademark), Ingredient A and Ingredient B Polymer, Product Code 4563 (Smith & Nephew). This is a commercially available open-cell foamed dressing that foams in the field. Guide curing time within 2 minutes.
P2 Mepiseal ™ (3 ml), Ingredient A and Ingredient B Polymers, reference number 283100 (Molnlycke). This is a commercially available distributable adhesive sealant intended to seal the wound exudate within the wound area so that it does not come into contact with intact skin. Guide curing time within 20 minutes.
P3 Elastosil SC870, component A and B polymers. This is a commercially available black foamable elastomer. Guide curing time within 90 minutes, (pot life 150 seconds, semi-curing time 10-15 minutes, density 0.35-0.4, shore hardness 8-12).
P4 Silpuran® 2445 A / B, Ingredients A and B Polymers, Reference Numbers 60063054 and 60063056 (both Wacker Chemie AG). This is a commercially available elastomer for casting as a prosthesis alignment, cushioning member, etc. Guide curing time within 25 minutes.
P5 Silpuran 2400/18 A / B (Wacker) is an add-curable RTV-2 silicone rubber that cures to a low hardness blue silicone. It has applications in flexible molding applications for prostheses. Guide curing time at 120 ° C for 1 hour.
P6 Silpuran 2111 A / B (Wacker) is a commercially available bipartite curable silicone composition that cures into a soft, sticky silicone adhesive. Suitable for use in wound dressings. Guide curing time at 120 ° C for 1 hour.
P7 Elastosil SC835, Ingredients A and B polymers. It is a commercially available reddish brown foaming elastomer. Guide curing time within 90 minutes (pot life 240 seconds, semi-curing time 10 to 15 minutes, density 0.4 to 0.45, shore hardness 20)
P8 Silbione RTV 4511 A / B (Bluestar), this commercially available composition is modified to reduce cure time and temperature when applied to or around the wound site.
P9 Silbione LSR 4301 A / B (Bluestar), this commercially available liquid silicone rubber composition would be unfavorable for application at or around the wound site.

Treatment A
A TNP coating (PICO ™ 15 × 20 cm) similar to that shown in Figure 1 was glued to an acrylic or glass or aluminum plate with the adhesive side down and shown in Figures 2B and 2C. Negative pressure was established by connecting to a pump as shown in. After it was established that a good seal had been formed, the pump was turned off and the end of the dressing opposite the pump was removed by slicing, as shown in Figure A1. By removing a portion of the dressing, the transmission layer and other inner layers were exposed, as shown in FIGS. 3A-3C.

The sealant construct was loaded into the cylinder of the static mixer and dispensed from it to cover the exposed edges of the dressing as shown in Figure CII, but with the upper surface of the dressing adjacent to the exposed edges and Both plates were heavily overlapped. After 90 minutes, the pump was turned on again to determine if a good seal was formed.

(Example 1) --Application of CaviCare to the covering edge A covering material was applied to the acrylic plate according to the above-mentioned treatment A. The composition was dispensed and cured within 2 minutes. In this application, the sealed coating leaked through the open cells of the foam, but due to the nature of the foam structure of this composition, it behaves differently under different conditions, eg, the cell is exposed to an external load. We have observed that crushing results in gas permeability and the composition is well optimized to achieve cell closure.
The distribution was acceptable.

(Example 2)-Application of Elastosil to the covering edge A coating was applied to the acrylic, glass, and aluminum plates according to procedure A as described above. Adhesion was better with glass than with acrylic and with aluminum than with glass. The composition was dispensed and cured, and after 90 minutes the pump was turned on. Leakage was significant in the case of dressings sealed and trimmed on acrylic plates, and at low levels when sealed on glass and aluminum plates, requiring intermittent pump activity. This was a factor of adhesion to the plate, not the dressing for which adhesion was acceptable. The cured sealant was difficult to remove from acrylic and glass substrates, but was easier to remove from aluminum.

(Example 3) --Application of Silpuran 2445 to the covering edge A covering material was applied to the glass plate according to the above-mentioned procedure A. The constituents were distributed and allowed to cure overnight. The sealed dressing works well, a very good seal is established and it is almost necessary to turn on the pump after the negative pressure is first established within the sealed and trimmed dressing. There wasn't.

Treatment B
It was applied to the glass plate according to the procedure described above for A, but the construct was injected directly into the exposed transfer (spacer) layer, as shown in Figures BI, BII, and CI.

(Example 4) --Direct injection of CaviCare into the exposed transmission layer Followed procedure B. The composition did not appear to penetrate the dressing and appeared to be hindered by a dense superabsorbent polymer (SAP) layer. Very poor seals were observed during pump operation, and continuous operation of the pump failed to achieve the required vacuum.

(Example 5) --Direct injection of Mepiseal into the exposed transmission layer Results similar to Example 4

(Example 6a) -SAP removed and direct injection of Elastosil SC 870 into the exposed transfer layer The composition was observed to penetrate approximately 1 cm into the transfer layer. It was observed that the upper surface of the backing layer lifted slightly during foaming and curing. It was a good seal, but too much of the constituents were present at the edges of the lifted dressing.

(Example 6b)-SAP removed and direct injection of Silpuran 2445 into the exposed transfer layer The dressing did not lift as in Example 6 and good sealing and vacuum were established immediately.

(Example 7) -SAP was removed and Mepiseal was directly injected into the exposed transfer layer. As in Example 6b, the dressing did not lift.

(Example 8) -SAP was removed and CaviCare was directly injected into the exposed transmission layer. As in Example 6b, the dressing did not lift, but the permeation was 1.5-2 cm due to foaming action. There was no vacuum due to the open cell structure.

CONCLUSIONS The gas-impermeable curable sealant dispensed to externally coat and / or impregnate the exposed transfer layer was surprisingly effective. The seal was perfect and both modes were visually effective.

Further samples
(Example 9) --The above-mentioned procedure A was performed on the following samples.
9.1 Stoma Paste-The paste block gave obedience to the covering edge and acted to stick. The seal was robust. Disadvantages included the risk of bacterial loading due to pre-application action and the seal height exceeding the coating height.
9.2 Adhesive Gel Strips-The strips are adhesive on both sides and a good seal was obtained by applying one side to the dressing. The disadvantage is that the exposed surface is sticky and the seal deteriorates within a few days when the strip loses its stickiness.
9.3 Shaving Gels-Non-foaming gels are low viscosity, with a sufficient amount of gel drawn into the transfer layer and the aqueous component of the gel filling the superabsorbent layer to create a negative pressure coating. Delivery was stopped.
9.4 germolene-The cream was low viscosity and was drawn into the transmission layer, crushing the seal and causing a negative pressure leak.
9.5 Savlon Spray-The spray acts by forming a liquid film on the skin, evaporating water and leaving a polymeric drug. In this example, the spray was unable to produce a film capable of cross-linking the interface between the absorbent and the transmission layer against the skin. Two discrete films were formed on the surface of the backing layer, one on the wound model representing the skin. No seal was formed.
9.6 Elastosil SC835 (Wacker)-A fairly high foam seal was formed in the exposed area and some components were pulled into the transmission layer to a depth of 1-2 mm. The seal adhered strongly to the wound model and looked robust.
9.7 Elastosil SC870 (Wacker)-A foam seal of considerable height, comparable to 9.6, was formed on the exposed area. However, this composition is more viscous to apply and the resulting seal is less elastic than the SC835.

A method as described in WO2013076450 was used, which incorporates the measurement content of the components by reference herein.

(Example 10.1) --Viscosity measurement Viscosity is a measure of the resistance of a fluid to deformation due to shear or tensile stress and is an indicator of the fluidity of a liquid, suspension, or slurry. The viscosity of the sample is measured using a rotary viscometer that simultaneously measures the shear rate and shear stress. Vaseline® originals, moisturizing shaving gels Nivea Men Originals, and Germolene disinfectant creams were independently tested on a conical flat rheometer using a 60 mm diameter 2 ° steel cone. Samples were tested over a shear rate range of 5-15 s ^-1 at 20 ° C. according to DIN EN ISO 3219, 1994, Annex B. Viscosity is calculated using shear stress at a shear rate of 10s ^-1 and is given in Pa.s units.

Calculation

result
The NB: RENASYS stoma strip paste was too viscous and sticky to allow a suitable sample structure with the width required for the instrument, so its viscosity could not be measured.

(Example 10.2) --Measurement of compression rate The compression rate was determined as a criterion for penetration by the plunger. A Setamatic Penetrometer with an auto-release, timing device, and standard 47.5g plunger was used. A hollow plastic cone with a stainless steel tip weighing 15 g was attached to the device. A convection time of 60 seconds was used. * Measurements were recorded in three ways (n = 3).

These values can be considered acceptable, subject to the desired performance requirements of the system.

(Example 10.3) Extensibility, permanent strain, tensile strength, elongation at break

(Example 11) --Extensibility test of spacer layer (transmission layer)
Baltex
Reference description
A spacer layer
B EU33 Top Film, Chemoposite 11C-450 Air Laid Superabsorbent Pad, Baltex Reference Number 7970, Batch Number T0061 Spacer Layer, and ALLEVYN Gentle Border Wound Contact Layer (Non-sterile and Handmade)
Method
SOP / QPM / 230 (1003423) Stretchability Results

Conclusion The spacer layer provided good (ie low) elongation. Once the material was incorporated into a dressing with a superabsorbent pad, extensibility was limited.

(Example 12) --Silpuran 2400
Silpuran was tested with treatments A and B described above. The following results were shown. This composition had a very long curing time and low viscosity and was expected to simply deviate from its pre-curing position. In practice, the construct demonstrated a surprisingly effective seal, but in Treatment B, it showed a dramatic performance difference depending on the distribution, depending on the presence or absence of the absorbent layer. The constructs gave excellent results when distributed according to Treatment B.

The Silpuran 2400 was then dispensed internally according to the procedure of the second embodiment shown in FIG. C1. The constituents were well retained within the transmission layer, requiring only a small amount of constituents. This makes it possible to use small volume syringes with the benefit of back pressure. It was important to use small diameter nozzles to minimize spillage and minimize skin contact components. Distributing was still ineffective when the method of treatment A was used on the hyperabsorbent layer, but was very effective when treatment B was used on a single transmission layer in the trimmed area. The transmission layer may be a spacer or ADL, but it is preferable to omit the shielding layer in order to monitor distribution and seal formation, and the transmission layer is preferably an ADL type layer or a combination of ADL and spacer. , The risk of the spacer layer puncturing the backing layer is minimized.

Composition: Silpuran 2400/20, Component A and Component B Polymer (Wacker)
Silpuran 2400
Ingredient A
Color Translucent Viscosity (Flat / Conical) DIN EN ISO 3219 1800m Pa.s
Density DIN EN ISO 2811, 1.00g / cm ³
Ingredient B
Color Translucent Viscosity (Flat / Conical) DIN EN ISO 3219 1800m Pa.s
Density DIN EN ISO 2811 1.00g / cm ³
Product data (catalytic A + B)
Mixing ratio A: B 1: 1
Color translucent pot life 21 minutes at 23 ° C Product data (curing)
Shore A hardness (ISO 868) 7
Shore 00 Hardness (ASTM 2240 / Type 00) 55
Tensile strength (ISO 37) 2.00N / mm2
Break elongation (ISO 37) 600%
Tear strength (ASTM D 624 B) 3.0 N / mm
Curing conditions: 10 minutes / 100 ° C

Run 8A
Followed the details of procedure A of the patent specification with the application of Silpuran 2400/20.
Dressing before application of Silpuran 2400/20
A torch / flash was used to inspect the reflection of the dressing silicone immediately after application of Silpuran 2400/20 and to ensure that there were no pinholes in the composition immediately after application.
Hardened composition (after 90 minutes, hardening above the finger movement point was confirmed).
The sealant was not effective because there was no hardened sealant across the cut surface.
The gap was demonstrated.

Run 8B
Following the details of procedure B of the patent specification with the application of Silpuran 2400/20.
Dressing before application of Silpuran 2400/20
Immediately after application of Silpuran 2400/20, the dressing cured composition (after 90 minutes, curing beyond the finger movement point was confirmed).
The sealant was effective when distributed directly to the transmission layer.
When the cured silicone was inside, the spacer layer was more elastic to compression than the unfilled spacer, but of the sealant compared to Run 8A, where the same sealant was applied across the cut surface. It was noted that the profile was less noticeable and (subjectively) the stiffness was significantly lower.

The following was observed. When sealing the interior space of the transmission layer, the sealant required was significantly less, whereas sealing over the cut end.

When the sealant was applied into the interior space of the transmission layer, it sealed over the cut ends, whereas the resulting finish was significantly cleaner. The silicone flowing over the wound model resulted from the fact that the nozzle aperture was not sufficient to penetrate deep into the spacer layer and therefore delivered the silicone near the edges of the cut transmission layer. .. A distribution nozzle with an external caliber small enough to penetrate the transfer layer can be inserted into the transfer layer (up to a selected distance) during distribution and can move the distance back from the transfer layer of the cured silicone. I was able to limit the amount.

The absence of a shielding or opaque layer above the bridge in Execution 8B (such as the absorbent layer present in Execution 8A) allowed the user to clearly see the sealant entering the bridge during distribution. This gives control over where the sealant is applied and allows the user to ensure that no air passages remain on the seal.

The low viscosity of Silpuran 2400/20 was an important advantage during partitioning. It seemed to flow well into the transmission layer and easily fit into the internal shape of the transmission layer. The low viscosity material will also have the additional advantage of reducing the back pressure generated by the distribution unit. This reduces the back pressure generated by the liquid moving through the resulting narrow orifice using a distribution nozzle with a narrow aperture (which penetrates the transmission layer as desired). In some cases, it can be particularly important. It is related to the force that the user needs to apply to the syringe plunger to drain the liquid to provide an example of the effect of back pressure on a dispenser with a double cylinder syringe with an integral mixer. Let's go.

(Example 13) Dispenser design A dispenser with a single nozzle penetrating the transmission layer can be an advantage. Dispensers with multiple nozzles can be an advantage, but the width of this head limits the injection of sealant into the dressing that follows the contours of the body. Therefore, the width of the mixing head must be balanced between ease of application (wider is better) and follow-up to body contours (narrower is better). Alternatively, the mixing head must be shape-fitting so that it can be moved and shaped (ideally, once moved, it stays in place), allowing the user to approximate the shape. Given that it enters the transmission layer at an acute angle to the skin, one must consider the play of the dispenser.

The results of the above examples are illustrated as follows.
Results of Example 6b Example 3 Silpuran 2445

Results of Example 10, Example 5, Execution 1a
Elastosil SC835, Wacker Silicones
Distribution Source Medmix Systems AG, Double-Cartridge Prefilled Delivery System (S-System), Dispenser 25ml 1: 1/2: 1 Medical Plane, Parts: DS 24-01-OOM; Cartridge 25ml, 1: 1, PP Natural, Medical, Parts: CS 025-01-32M; Piston A, 25ml, 4: 1, PE Natural, Silicon O-ring Medical, Parts: KSA 25-04-02SM; Mixer, DN6.5 × 16, 1: 1 / 2: 1, green, parts: MB 6.5-16-S; and cap, 1: 1/2: 1, PE natural, medical, parts: VB 200-SM.

Example 5, Execution 1b

Example 5, Execution 2
RENASYS Glue Gel Patch, 10cm x 7cm, Reference Number 66801082, Smith & Nephew

Example 5, Execution 3
RENASYS Stoma Strip Paste Suitable RENASYS-G gauze kit-derived ingredient, Smith & Nephew

Example 5, Execution 4
Vaseline® Original, 100ml, Natural Petroleum Jelly (Ingredient: Petroleum), Unilever

Example 5, Execution 5
Moisturizing shaving gel, Nivea Men, Originals, 200 ml pressurized container, Beiersdorf

Example 5, Execution 6
Germolene, antiseptic cream (phenol and chlorhexidine digluconate), 55 g tube, Bayer plc

Example 5, Execution 7
Savlon, spray plaster, sterile when applied, in 40 ml pressurized container, Novartis Consumer Health

Composition of Example 12: Silpuran 2400/20, Component A and Component B Polymer (Wacker)
Run 8A
Followed the details of procedure A of the patent specification with the application of Silpuran 2400/20.

Dressing before application of Silpuran 2400/20

Dressing immediately after application of Silpuran 2400/20

The sealant was not effective because there was no hardened sealant across the cut surface. The gap was demonstrated.

Run 8B
Following the details of procedure B of the patent specification with the application of Silpuran 2400/20.

Dressing before application of Silpuran 2400/20

Dressing immediately after application of Silpuran 2400/20

Cured composition (after 90 minutes, curing above the finger movement point was confirmed).

100 Wound Treatment System
110 Wound dressing
120 ports
130 conduit
140 connector
150 pump
200 Wound site
210 strips
500 dressing
510 backing layer
520 main part
530 Bridge part
540 additional part
550 ports
560 gap
570 cutting line
600 dressing
610 outer circumference
620 cells
630 bridge part
640 port member
650 gap
700 dressing
710 Outer circumference
720 cells
730 bridge part
740 gap
750 holes
760 tabs
800 dressing
820 Absorbent layer
830 spacer layer
840 holes
850 tabs
1600 dressing
1610 Outer circumference
1620 Bridged part
1630 Absorbent pad part
1640 port
1650 Auxiliary absorbent part
1662 Spacer layer
1664 ADL
1666 Absorbent layer
1668 Masking layer
1672 Wound contact layer
1674 Top film layer
2100 Wound dressing
2101 Lower surface
2102 Wound contact layer
2103 Upper surface
2104 Perforation
2105 Transmission layer
2107 Shielding layer
2110 Absorbent layer
2115 Absorbent cell
2120 port
2125 conduit
2130 filter element
2140 backing layer
2145 Orifice
2146 Through hole
2150 ports
2152 spacer element
2153 spacer element
2200 boundary area
2305 Upper layer
2310 Lower layer
3400 dressing
3410 Backing layer
3411 Orifice
3420 Shielding layer
3421 Malta Cross
3422 Viewing window
3430 Absorbent layer
3431 Through hole
3440 Acquisition distribution layer
3450 Transmission layer
3460 Wound contact layer
3480 release layer
3481 flap
3900 dressing
3910 Backing layer
3920 Shielding layer
3930 Absorbent layer
3940 Acquisition distribution layer
3950 transmission layer
3960 Wound contact layer
3970 Adhesive layer
3980 release layer
3990 port
3995 Filter element
3997 3D fabric
4210 Patterned layer
4220 layers
4230 Superabsorbent particles
4240 layers
4250 layers
A, B part
C composition

Claims (8)

A distributable sealant composition for wound care used with wound dressings .
The wound dressing
A backing layer having an upper surface and a lower surface, which defines an outer periphery configured to be positioned on the skin surrounding the wound site.
With any wound contact layer,
With one or more transmission layers provided directly or indirectly to the lower surface of the backing layer.
A port configured to transmit negative pressure through the backing layer for applying local negative pressure to the wound site.
A part of the transmission layer is exposed by trimming .
The distributable sealant construct is distributed in the exposed portion of the transmission layer so as to at least cover the exposed portion of the transmission layer and seal the exposed portion of the transmission layer to the external environment. ,
The sealant composition is a curing system and is
The cured sealant composition is fluid impermeable.
Sealant composition. The seal formed by the cured sealant construct has a compressibility in the range of 20-500 / 10 mm.
The sealant composition according to claim 1, wherein the seal has an extensibility of 1.00 to 2.50 kgf cm- ² . The sealant composition is a curing system and is
The curing system is a curable one-component or multi-component composition, for example, a one-component, two-component or multi-component silicone system, a silicone curing system containing various curing mechanisms, an epoxy curing system, a cyanoacrylate curing system, and a polyurethane. Curable systems, polymer systems functionalized with silicone crosslinked functional groups, polymer systems functionalized with polyurethane curable functional groups, dry systems such as fluids made elastomeric by the presence of volatile solvents, in water or solvent bases. The sealant composition according to claim 1 or 2 , selected from spray-type polymers such as acrylic, UV or photocurable systems. The sealant composition is Ru is selected from the cured silicone containing addition-curable RTV-2 silicone claim 1 or 2 sealant composition according. The sealant composition is a curing system distributed between at least one component A and at least one component B.
One or more alkenyl group-containing polymers (i), having at least one alkenyl group or alkenyl moiety per molecule,
One or more SiH-containing polymers (ii), with at least one Si—H unit per molecule, and
The sealant composition according to claim 1 or 2 , which comprises a catalyst (iii) for curing by adding an alkenyl group-containing polymer (i) to a SiH-containing polymer (ii) . The sealant composition has fluidity such that when the sealant composition is distributed to the transmission layer, the sealant composition can be stretched within the exposed portion of the transmission layer .
At least a portion, said sealant composition has penetrated into the transfer layer to a distance of from 1mm to 10mm when cured, sealant arrangement according to any one of claims 1 to 5 wherein the sealant composition Stuff. Constituents for use in sterile field or environmental medical applications as adhesive or adhesive sealants for negative pressure wound therapy, the cured sealant components, the sealant components on the wound dressings. Ru airtight der to be able to maintain the added negative pressure, the sealant composition according to any one of claims 1 to 6. A kit suitable for use in the field of wound wound care,
The distributable sealant construct according to claim 1, which covers the wound site and the skin around the wound site .
A component distribution device containing the sealant component and
Wound dressing
A backing layer having an upper surface and a lower surface, which defines an outer peripheral portion configured to be positioned on the skin surrounding the wound site.
With any wound contact layer,
With one or more transmission layers provided directly or indirectly to the lower surface of the backing layer.
A port configured to transmit negative pressure through the backing layer to apply local negative pressure to the wound site.
With a wound dressing and
A kit that includes.