Collapsible dressing for negative pressure wound treatment.
Abstract
Embodiments disclosed herein are directed to negative pressure treatment systems and wound dressing systems, apparatuses, and methods that may be used for the treatment of wounds. In particular, some embodiments are directed to improved wound dressings comprising an obscuring layer that may hide fluid contained therein and a stabilizing structure that may aid in wound closure.

Term
8.3 yearsleft in the term
Expires 20 January 2035.
- Priority
- Filed
- Granted
- Today
- Expires
15 claims: 11 independent, 4 dependent
- 1NOVEDAD DE LA INVENCIÓN REIVINDICACIONES 1. Un aparato de tratamiento de heridas con presión negativa, que comprende:un vendaje para heridas que comprende una capa de soporte y una estructura de estabilización posicionada por debajo de la capa de soporte, en donde la capa de soporte y la estructura de estabilización están configurados como una sola unidad para la colocación de manera simultánea sobre una herida, y en donde la estructura de estabilización se configura para la colocación sobre la piel que rodea la herida;un puerto para la comunicación de presión negativa al vendaje de heridas;y en donde la estructura de estabilización está configurada para plegarse significativamente más dentro de un plano horizontal que en un plano vertical para aplicar una fuerza horizontal a la piel que rodea la herida cuando el vendaje de heridas se coloca bajo presión negativa.
- 2El aparato de conformidad con la reivindicación 1, caracterizado además porque el vendaje para heridas comprende además una capa de contacto con la herida, en donde la estructura de estabilización está situada entre la capa de soporte y la capa de contacto con la herida.
- 3El aparato de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque el vendaje para heridas comprende además una capa de distribución de adquisición entre la estructura de estabilización y la capa de soporte.
- 4El aparato de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque el vendaje para heridas comprende además una capa absorbente entre la estructura de estabilización y la capa de soporte.
- 5El aparato de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque comprende un adhesivo configurado para fijar el vendaje para heridas a la piel que rodea la herida.
- 6El aparato de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque el vendaje para heridas está configurado para aliviar la tensión aplicada a las suturas aplicadas a la herida.
- 7El aparato de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque la capa de soporte es transparente o translúcida.
- 8El aparato de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque la estructura de estabilización es menor que el 20% tan gruesa como su ancho o su largo.
- 9Un aparato de tratamiento de heridas con presión negativa, que comprende:un vendaje para heridas que comprende una capa de soporte, una capa absorbente, y una estructura de estabilización posicionada por debajo de la capa absorbente, en donde la capa de soporte, capa absorbente, y la estructura de estabilización están configurados como una sola unidad para la colocación de manera simultánea sobre una herida, y en donde el estructura de estabilización está configurada para la colocación sobre la piel que rodea la herida;en donde la capa absorbente 5 comprende una pluralidad de orificios pasantes;en donde la estructura de estabilización está configurada para plegarse significativamente más dentro de un plano horizontal que en un plano vertical para aplicar una fuerza horizontal a la piel que rodea la herida cuando el vendaje de heridas se coloca bajo presión negativa.
- 10El aparato de conformidad con la reivindicación 9, caracterizado además 10 porque al menos parte de la pluralidad de orificios pasantes se rellena con un material de tapón para proporcionar la capa absorbente con una mayor rigidez vertical.
- 11El aparato de conformidad con la reivindicación 10, caracterizado además porque el material de tapón es transparente.
- 12El aparato de conformidad con cualquiera de las reivindicaciones 9 a 11, 15 caracterizado además porque la capa absorbente está configurada para plegarse significativamente más dentro de un plano horizontal que en un plano vertical.
- 13El aparato de conformidad con cualquiera de las reivindicaciones 9 a 12, caracterizado además porque comprende una capa de contacto con la herida debajo de la estructura de estabilización. 20
- 14El aparato de conformidad con cualquiera de las reivindicaciones 9 a 13, caracterizado además porque la capa de soporte es transparente.
- 15El aparato de conformidad con cualquiera de las reivindicaciones 9 a 14, caracterizado además porque comprende además material de tapón dentro de las celdas de la estructura de estabilización.
Independent claims15
259 paragraphs in 7 sections, as filed
(54) Title: FOLDABLE BANDAGE FOR THE TREATMENT OF WOUNDS WITH NEGATIVE PRESSURE. (54) Title: COLLAPSIBLE DRESSING FOR NEGATIVE PRESSURE WOUND TREATMENT.
(57) Summary
The modalities described in this document are directed to negative pressure treatment systems and wound dressing systems, apparatus and methods that can be used for wound treatment; in particular, some modalities are aimed at improving wound dressings that comprise a darkening layer that can hide the fluid contained therein and a stabilization structure that can aid in wound closure.
(57) Abstract
Embodiments disclosed herein are directed to negative pressure treatment systems and wound dressing systems, apparatuses, and methods that may be used for the treatment of wounds. In particular, some performances are directed to improved wound dressings comprising an obscuring layer that may hide fluid contained therein and a stabilizing structure that may aid in wound closure.
FOLDABLE BANDAGE FOR THE TREATMENT OF WOUNDS WITH NEGATIVE PRESSURE
CROSS REFERENCE TO RELATED REQUESTS
This application claims the benefit of US provisional application No. 61 / 929,870, filed on January 21, 2014, and titled COLLAPSIBLE DRESSING FOR NEGAT1VE PRESSURE WOUND TREATMENT. The contents of the aforementioned application are hereby incorporated by reference in their entirety as if set forth herein. The priority benefit of the previous application is claimed under the appropriate legal basis, including, without limitation, under 35 USC §119 (e).
FIELD OF THE INVENTION
The modalities described in this document relate to apparatus, systems, and methods for wound treatment, for example, by the use of dressings in combination with negative pressure wound therapy. The modalities herein may be particularly useful for the treatment of incisional wounds.
BACKGROUND OF THE INVENTION
Negative pressure wound therapy has become a common therapy for the treatment of certain types of wounds, often improving the speed of healing and at the same time removing exudates and other harmful substances from the wound site. In some cases, negative pressure wound therapy is applied to incision wounds, such as those resulting from surgical procedures. However, existing negative pressure wound treatment systems lack adequate mechanisms to apply closing force to the wound and / or support the sutures or other fixation means used to seal the incisional wound.
Furthermore, prior art bandages for use with negative pressure have been difficult to apply, particularly around curved or non-flat body surfaces. After application of negative pressure, exudate from the wound can be soaked in the bandage, which can be aesthetically unpleasant and potentially embarrassing in social situations.
BRIEF DESCRIPTION OF THE INVENTION
The modalities of the present invention refer to negative pressure wound treatment and closure devices, methods and systems that facilitate the closure and treatment of a wound. Devices, methods, and systems can be used simultaneously with negative pressure to remove fluids from the wound.
In some embodiments, a negative pressure wound treatment apparatus comprises:
a wound dressing comprising a support layer and a postcloned stabilization structure below the support layer, wherein the support layer and stabilization structure are configured as a single unit for simultaneous placement on a wound , and where the stabilization structure is configured for placement on the skin surrounding the wound;
a port for negative pressure communication to the wound dressing; and wherein the stabilization structure is configured to fold significantly more within a horizontal plane than in a vertical plane to apply horizontal force to the skin surrounding the wound when the wound dressing is placed under negative pressure.
In certain embodiments, the wound dressing further comprises a wound contact layer, in which the stabilization structure is located between the support layer and the wound contact layer.
In any of the modalities above or described elsewhere in this specification, the wound dressing further comprises an acquisition and distribution layer between the stabilization structure and the support layer.
In any of the embodiments above or described elsewhere in this specification, the wound dressing further comprises an absorbent layer between the stabilization structure and the support layer.
In any of the embodiments above or described elsewhere in this specification, the apparatus further comprises tissue anchors configured to attach the wound dressing to the skin surrounding the wound and / or to the stabilization structure.
In any of the embodiments above or described elsewhere in this specification, the apparatus further comprises an adhesive configured to attach the wound dressing to the skin surrounding the wound.
In any of the modalities above or described elsewhere in this specification, the wound dressing may be configured to relieve stress applied to sutures applied to the wound.
In any of the embodiments above or described elsewhere in this specification, the backing layer is transparent or translucent. In any of the modalities above or described elsewhere in this specification, the wound dressing further comprises a darkening layer between an absorbent layer and the support layer. In any of the embodiments above or described elsewhere in this specification, the stabilization structure may be less than 20% as thick as its width and length.
In some embodiments, a method of treating a wound with an apparatus as described herein in this section or elsewhere in the specification comprises:
placing the wound dressing on the wound with the stabilization structure placed on the skin surrounding the wound;
applying negative pressure to the wound through the port; and wherein the stabilizing structure applies a horizontal force to the skin surrounding the wound when placed under negative pressure.
In certain embodiments, a negative pressure wound treatment apparatus may comprise:
a wound dressing comprising a support layer, an absorbent layer, and a stabilization structure positioned below the absorbent layer, wherein the support layer, absorbent layer, and the stabilization structure are configured as a single unit for simultaneous placement on a wound, and wherein the stabilization structure is configured for placement on the skin surrounding the wound;
wherein the absorbent layer comprises a plurality of through holes; wherein the stabilization structure is configured to fold significantly more within a horizontal plane than in a vertical plane to apply horizontal force to the skin surrounding the wound when the wound dressing is placed under negative pressure.
In particular embodiments, at least part of the plurality of through holes can be filled with a plug material to provide the absorbent layer with increased vertical stiffness. The material of the plug can be transparent. In embodiments, the absorbent layer is configured to fold significantly more within a horizontal plane than in a vertical plane. Some embodiments may further comprise a wound contact layer below the stabilization structure. In certain embodiments, the backing layer may be transparent. In some embodiments, the plug material may be located within the cells of the stabilization structure.
Other non-limiting modalities of wound closure and / or treatment devices, stabilizer structures and associated apparatus are described below.
BRIEF DESCRIPTION OF THE DRAWINGS
Modes of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:
Figure 1 illustrates one embodiment of a wound treatment system.
Figures 2A to 2E illustrate the use and application of one embodiment of a wound treatment system to various wounds.
Figures 3A to 3B illustrate modalities of applying a wound dressing to an accidental wound.
Figures 4A to 4D illustrate different views of modalities of a stabilization structure that can be used in a wound dressing.
Figures 5A to 5E illustrate different views and photographs of modalities of a stabilization structure that can be used in a wound dressing.
Figures 6A to 6D illustrate additional embodiments of a stabilization structure.
Figures 7A to 7C illustrate one embodiment of a stabilizing structure made of felt foam.
Figures 8A to 8B are photographs of additional embodiments of stabilization structures comprising a porous wound filling material.
Figures 9A to 9B, 10, 11, 12, 13, and 14 illustrate additional embodiments of a stabilization structure.
Figures 15A to 15E are photographs of various modalities of the stabilization structures comprising Inserts arranged in their Interior.
Figures 16A to 16F illustrate various modes of Inserts that can be used in stabilization structures.
Figures 17A to 17F illustrate various views of one embodiment of a stabilization structure.
Figures 18A to 18D illustrate various views of one embodiment of a stabilization structure.
Figures 19A to 19E illustrate various views of one embodiment of a stabilization structure.
Figure 20 schematically illustrates one embodiment of a stabilization structure.
Figure 21A illustrates a top view of one embodiment of an oval shaped stabilizing structure.
Figure 21B illustrates a top view of one embodiment of an oval shaped stabilizing structure with foam.
Figures 22A through 22C illustrate various views of one embodiment of a stabilizing structure.
Figures 23A to 23G illustrate various views of one embodiment of a stabilizing structure.
Figure 24 illustrates one embodiment of an articulated stabilizing structure for closing a wound.
Figure 25 illustrates one embodiment of a fully flexible stabilization structure.
Figure 26 illustrates one embodiment of a stabilization structure for a wound.
Figure 27 illustrates one embodiment of a stabilization structure cut from a roll.
Figure 28 illustrates one embodiment of a stabilizing structure having an oval shape.
Figures 29A to 29F illustrate various views of one embodiment of a stabilization structure.
Figures 30A to 30D illustrate various views of one embodiment of a stabilization structure comprising openings for the passage of fluid.
Figures 31A to 31C illustrate various modalities of a stabilization structure.
Figures 32A to 32B illustrate various embodiments of a stabilization structure comprising windows.
Figures 33A to 33C are photographs of various modalities of a stabilization structure comprising foam inserts.
Figures 34A to 34B are photographs of various modalities of tissue anchors.
Figure 35 is an illustration of one embodiment of a wound dressing comprising a stabilizing structure.
FIG. 36 is an illustration of an exploded view of an embodiment of a wound dressing comprising a stabilizing structure.
Figure 37 is an illustration of one embodiment of a stabilization structure in combination with a cloth and wound contact layer.
FIG. 38 is an illustration of one embodiment of a wound dressing comprising an absorbent layer with through holes.
FIG. 39 is a top view illustration of one embodiment of a wound dressing comprising an absorbent layer with through holes.
DETAILED DESCRIPTION OF THE INVENTION
The modalities described in this document relate to apparatus and methods of treating a wound with reduced pressure, including the pump and components of wound dressings and apparatus. In general, the modalities that include the dressings described in this document can be used in combination with a negative pressure system that comprises a cloth or wound cover placed over the filling. A vacuum source, such as a pump, can be connected to the deck, for example, through one or more tubes connected to an opening or port made in, or below, the deck.
It will be appreciated that a wound is referred to throughout this specification. It is understood that the term wound should be constructed broadly and encompasses open and closed wounds where the skin is torn, cut, or punctured, or when trauma causes a contusion, or any other superficial or other condition or imperfection on a patient's skin or otherwise benefiting from a reduced pressure treatment. A wound is therefore broadly defined as any damaged area of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds, incisional wounds, whether as a result of surgery or other means, trauma, sternotomies, fasclotomies, or other conditions, dehiscent wounds, acute wounds, chronic wounds, subacute and dehiscent wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.
As used in this section or elsewhere in this specification, reduced or negative pressure levels, such as -X mmHg, represent pressure levels that are below standard atmospheric pressure, which corresponds to 760 mmHg (or 1 atm , 29.93 InHg, 101,325 kPa, 14,696 psl, etc.). Consequently, a negative pressure value of -X mmHg reflects the absolute pressure that is X mmHg below 760 mmHg or, in other words, an absolute pressure of (760-X) mmHg. Also, the negative pressure that is less or less than X mmHg corresponds to the pressure that is closest to atmospheric pressure (for example, -40 mmHg is less than -60 mmHg). The negative pressure that is more or greater than -X mmHg corresponds to the pressure that is furthest from atmospheric pressure (for example, -80 mmHg is more than -60 mmHg). Unless otherwise indicated, the term "approximately" is intended to represent a range of +/- 10% of the stated value.
The negative pressure range for some embodiments of the present disclosure may be about -80mmHg, or between about -10mmHg and -200mmHg. Note that these pressures are relative to normal ambient atmospheric pressure. Therefore -200 mmHg would be approximately 560 mmHg in practical terms. In some embodiments, the pressure range can be between approximately -40 mmHg and -150 mmHg. Alternatively, a pressure range of up to -75mmHg, down to -80mmHg or more than -80mmHg can be used. Also in other modalities a pressure range below -75 mmHg can be used. Alternatively, a pressure range of more than about -100mmHg, or even -150mmHg, can be supplied by the negative pressure apparatus. In some modalities, the negative pressure range can be as small as about -20 mmHg or about -25 mmHg, which can be helpful in reducing fistulas. In some modalities of wound closure devices and stabilizing structures described in this specification, increased wound contraction may lead to increased tissue expansion in the surrounding wound tissue. This effect can be increased by varying the force applied to the tissue, for example by varying the negative pressure applied to the wound over time, possibly in conjunction with an increase in the tensile forces applied to the wound by means of modalities of wound closure devices. In some embodiments, the negative pressure can be varied over time, for example, using a sine wave, square wave, and / or in synchronization with one or more of the patient's physiological indices (eg, heart beat). Examples of such applications where the additional description related to the preceding can be found include Application No. from Series 11 / 919,355, entitled Wound treatment apparatus and method, filed on October 26, 2007, published as US 2009/0306609; and US Patent No. 7,753,894, entitled Wound cleansing apparatus with stress, issued on July 13, 2010. Both applications are incorporated by reference in their entirety. Other requests that may contain teachings relevant for use with the modalities described in this section or elsewhere in this specification may include Request Serial No. 12 / 886,088, titled Systems And Methods For Using Negative Pressure Wound Therapy To Manage Open Abdominal Wounds, filed on September 20, 2010, published as US 2011/0213287; Application No. Serial No. 13 / 092,042, entitled Wound Dressing And Method Of Use, filed April 21, 2011, published as US 2011/0282309; and application Serial No. 13 / 365,615, entitled Negative
Pressure Wound Closure Device, filed on February 3, 2012, published as US 2012/0209227. Furthermore, any of the modalities described in this document can be used without the application of reduced or negative pressure.
International application PCT / GB2012 / 000587, entitled WOUND DRESSING AND METHOD OF TREATMENT and filed on July 12, 2012 and published as WO 2013/007973 A2 on January 17, 2013, is an application, incorporated herein and considered part of this specification, which addresses modalities, manufacturing methods, and components of wound dressings and wound treatment apparatus that can be used in combination or in addition to the modalities described herein. Furthermore, the modalities of wound dressings, wound treatment apparatus and methods described herein can also be used in combination with or in addition to those described in US Provisional Application No. of Series 61 / 650,904, filed on May 23, 2012, entitled APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY, International Application NO. PCT / IB2013 / 001469, filed May 22, 2013, titled APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY, US Provisional Application Serial No. 61 / 678,569, filed August 1, 2012 titled WOUND DRESSING AND METHOD OF TREATMENT, US Provisional Application No. 61,753,374, filed on January 16, 2013, entitled WOUND DRESSING AND METHOD OF TREATMENT, US Provisional Application Serial No. 61 / 753,878, filed on January 17, 2013, titled WOUND DRESSING AND METHOD OF TREATMENT, Provisional Application U.S. Serial No. 61 / 785,054, filed March 14, 2013, entitled WOUND DRESSING AND METHOD OF TREATMENT, and U.S. Provisional Application No. Serial No. 61 / 823,298, filed May 14, 2013, entitled WOUND DRESSING AND METHOD OF TREATMENT, which are incorporated by reference in this entire application. The modalities of wound dressings, apparatus and methods of wound treatment described herein can also be used in combination with or in addition to those described in Application No. from Series 13 / 092,042, filed on April 21, 2011, published as US2011 / 0282309, entitled WOUND DRESSING AND METHOD OF USE, and which is incorporated herein by reference in its entirety, including more details regarding wound dressing modalities, the components of wound dressings and principles, and the materials used for wound dressings.
Other modalities of wound dressings can be found in PCT Application PCT / IB2013 / 002060, entitled WOUND DRESSING AND METHOD OF TREATMENT, filed July 31, 2013, and is incorporated by reference in its entirety. PCT Application PCT / IB2013 / 002060 is also attached to this application as Appendix A. The various modalities of bandages described in Appendix A can be used in combination with any of the modalities described in this document this section or in the specification elsewhere.
It will be understood that throughout this specification some reference to modalities is made for an elongated or longitudinal strip or strips. It is understood that these terms must be interpreted broadly and refer in some ways to an elongated material that has two parallel or substantially parallel faces, where in cross section a thickness of the material, measured perpendicular to the faces is relatively smaller than a height of the material measured parallel to the faces. While in some embodiments the strips can be constructed from discrete lengths of material, in other embodiments the strips can simply refer to elongated portions of an overall structure that has two parallel or substantially parallel faces. The strips in some embodiments have a rectangular shape or faces that are generally rectangular in shape, where a length of the face is longer than the height of the face. In some modalities, the length of the face can be more than 2 times, 4 times, 6 times, 8 times or 10 times greater than the height of the face.
As used in this section or elsewhere in this specification, the term horizontal, when referring to a wound, indicates a direction or plane generally parallel to the skin surrounding the wound. The term vertical, when referring to a wound, generally refers to a direction that extends perpendicular to the horizontal plane. The term longitudinal, when referring to a wound, generally refers to a direction in the horizontal plane taken in a direction along which the wound is longest. The term lateral, when referring to a wound, generally refers to a direction in the horizontal plane perpendicular to the longitudinal direction. The terms horizontal, vertical, longitudinal and lateral can also be used to describe the stabilization structures and wound closure devices described throughout this specification. In describing these structures or devices, these terms should not be interpreted to require that the structures or devices necessarily be placed on a wound in a certain orientation, although in certain modalities it may be preferable to do so.
FIG. 1 illustrates one embodiment of a negative pressure wound treatment system 100 comprising a wound dressing 110 in combination with a pump 150. FIG. 1 depicts a representative wound dressing with a waist portion, however, many Bandage modalities have different shapes / sizes such as those described herein in this section or elsewhere in this specification, including Appendix A. Wound dressing 110 may be, without limitation, dressing modalities or combinations of features of any number of wound dressing modalities described herein in this section or elsewhere in this specification, including Appendix A. Here, bandage 110 can be placed over a wound as described above, and conduit 130 can then be connected to port 120, although in some embodiments bandage 101 may be provided with at least a portion of conduit 130 previously attached to port 120. Preferably, bandage 110 is provided as a single article with all wound dressing elements (optionally including port 120) pre-attached and Integrated into a single unit. Wound dressing 110 can then be connected, via line 130, to a negative pressure source such as pump 150. Pump 150 can be miniaturized and portable, although larger conventional pumps can also be used with the bandage 110. In some embodiments, pump 150 may be attached to or mounted on or adjacent to bandage 110. A connector 140 can also be provided to allow conduit 130 leading to wound dressing 110 to be disconnected from the pump, which may be useful, for example during dressing changes. The modalities of the bandage of Figure 1 are described in more detail with respect to Figures 35 to 36, which also provide additional details on the specific internal components of the bandage modality depicted in Figure 1.
In some embodiments, fluid can be transported from bandage 110 and stored in a fluid collection container (not shown). Some embodiments may require that fluid be retained within the dressing such as within an absorbent material. The absorbent material may further comprise a superabsorbent polymer or a more conventional absorbent material, such as cellulose.
Figures 2A to 2E illustrate the use of one embodiment of a negative pressure wound treatment system used to treat a wound site in a patient. More details about the internal modality components of the dressings of Figure 2C to 2E are described in Figures 35 to 36. Figure 2A shows a wound site 200 being cleaned and prepared for treatment. Here, the healthy skin surrounding wound area 200 is preferably cleaned and excess hair removed or shaved. Wound site 200 can also be irrigated with sterile saline, if necessary. Optionally, a skin protector can be applied to the skin surrounding the wound site 200. If necessary, a wound packing material, such as foam or gauze, can be placed at the wound site 200 . This may be preferable if wound site 200 is a deep wound. In embodiments, the wound may be any type of wound described in this document in this section or in the specification elsewhere.
FIG. 2B illustrates an incisional wound site 202 that can be irrigated and prepared as the wound site 200 described in relation to FIG. 2A. Typical incisional wounds are created by a scalpel or other means during surgery to allow clinical access to the underlying tissues and organs. Incisional wound 202 may be closed, whereby the wound has been closed by sutures 204 or by other means such as an adhesive, or the incision wound may be open, where the wound has not yet closed. As described above, a wound is referred to throughout this specification and such a wound can be created by a variety of means, including through Incision means. Therefore, it will be understood by a person skilled in the art, when the term wound is used in the description of modalities herein, this section and other parts of the specification, the term wound encompasses internal wounds such as those described in the figure 2B.
After the skin surrounding the wound site 200 is dry, and referring now to FIG. 2C, the wound dressing 110 may be postcloned or placed over the wound site 200 or 202. Preferably, the wound dressing 110 is placed over and / or in contact with wound site 200. In some embodiments, an adhesive layer is provided on the Bottom surface of the dressing 110, which may in some cases be protected by an optional release layer to be removed prior to placement of the wound dressing 110 on the wound site 200. Preferably, bandage 110 is positioned such that port 120 is in an elevated position relative to the rest of bandage 110 in order to avoid clumping of liquid around the port. In some embodiments, bandage 110 is positioned so that port 120 does not directly cover the wound, and is flush with or at a point higher than the wound. To help ensure a proper seal for negative pressure wound therapy, the edges of bandage 110 are preferably smoothed over the top to prevent kinks or kinks. Referring now to Figure 2D, bandage 110 is connected to pump 150. Pump 150 is configured to apply negative pressure to the wound area through bandage 110, and typically through a conduit. In some embodiments, and as described above in Figure 1, a connect can be used to connect the conduit from bandage 110 to pump 150. Upon application of negative pressure with pump 150, bandage 110 may, in some embodiments, partially fold and present a wrinkled appearance, as a result of evacuation of some or all of the air below bandage 110. In some embodiments, Pump 150 may be configured to detect if leaks are present in bandage 110, such as at the interface between bandage 110 and the skin surrounding wound site 200. IF a leak is found, such leaks are preferably remedied before continuing treatment.
Returning to FIG. 2E, additional fixation strips 210 may also be attached around the edges of bandage 110. Such fixation strips 210 may be advantageous in some situations in order to provide an additional seal against the patient's skin surrounding the wound site 200. For example, fixation strips 210 can provide additional sealing for when a patient is most mobile. In some cases, fixation strips 210 can be used prior to activation of pump 150, particularly if bandage 110 is placed over a hard-to-reach or contoured area.
Wound site treatment 200 preferably continues until the wound has reached a desired level of healing. In some embodiments, it may be desirable to replace bandage 110 after a certain period of time has elapsed, or if the bandage is filled with wound fluids. During these changes, pump 150 can be maintained, with only bandage 110 being changed.
Figures 3A to 3B illustrate schematic modalities of a schematic of a wound dressing 110, similar to the modalities of bandages depicted in Figures 1 to 2E and 35 to 36, placed on an individual wound 202 closed with sutures 204. As In Figures 1 to 2E, such a bandage may be connected to a negative pressure source configured to apply negative pressure to a wound. In certain embodiments, the wound dressing 110 may be folded in a plane perpendicular to the vertical direction, thereby applying a horizontal force 206 to the internal wound 202. In embodiments, the dressing 110 may be folded in any manner described herein. in this section or elsewhere in the specification, particularly as described in greater detail below in relation to Figures 4A to 33C and Figures 35 to 36. For example, the bandage can be folded significantly more in the horizontal plane than in the vertical plane. By bending significantly more in the horizontal plane, the bandage can apply horizontal force to the wound, avoiding the potentially damaging application of vertical forces.
As depicted in Figures 1 to 3B, in certain embodiments, the wound dressing may have a rectangular shape. When viewed from a two-dimensional top view, as in the schematic of Figures 3A to 3B, the wound dressing can be folded significantly longer than the shortest dimension as depicted in Figure 3A or it can be folded significantly further along the longest dimension as depicted in Figure 3B. By folding along the axis of sutures 204, the bandage can assist in wound closure by applying wound closure force 206, and also serves to relieve tension on sutures 204. In some In modalities, the bandages of Figures 3A to 3B can also be elongated on an axis perpendicular to the axis of closure.
In embodiments, the bandage can adhere to the skin surface through any adhesion or bonding mechanism described herein in this section or elsewhere in the specification. For example, the bandage can be adhered to the skin using an adhesive, such as cyanoacrylate adhesives. In some embodiments, the bandage may adhere to the skin through tissue anchors, such as those described herein in this section or in much greater detail elsewhere in the specification. Adhesion of the bandage to the surrounding skin can allow the bandage to apply lateral closing forces to the wound by removing the tissues surrounding the wound together, as described above.
Wound dressings such as wound dressing 110 described above and elsewhere in this specification may include as part of the wound dressing a wound closure device or stabilization structure that facilitates closure of the skin surrounding the wound. For example, a wound dressing comprising a backing layer may further comprise a wound closure device or stabilization structure, as described below, which is incorporated as a wound dressing layer and configured to be applied to the wound at the same time as the support layer. The inclusion of a wound closure device or stabilization structure can facilitate the application of horizontal force to the skin surrounding the wound when the wound dressing is applied to the wound and adheres to the skin surrounding the wound . The wound closure device or stabilization structure, which can be placed on the skin surrounding the wound and adhere directly or indirectly to it, can be folded under negative pressure more in a horizontal direction than in a vertical direction, applying this mode a horizontal force to the skin surrounding the wound.
In the following, modalities of various wound stabilization structures and closure devices for use in a wound dressing will be described. Any of these modalities can be incorporated into the bandages described herein, as will be further described with respect to Figures 35 to 36 below. The stabilization structures of Figures 4A to 33C can be suitably sized to fit within the footprint of the bandages of Figures 1 to 2E, or any of the bandage shapes / sizes described herein in this section or in the specification in another place. In alternative embodiments, any of the stabilization structures described below need not be provided as a single unit at the same time with other components of a wound dressing, but may be individually and separately applied to a wound, such as on the skin surrounding a wound. In such alternative modalities, other wound dressing components, such as any of the layers described with respect to Figures 35 to 36, can be applied separately to the wound, and the stabilization structure together with other wound dressing components form wound dressing. Other modalities of wound stabilization structures and closure devices, as well as the corresponding methods of manufacture and use, are described throughout the specification and in the claims of International Application No. PCT / US2013 / 050619, filed on July 16. 2013, and International Application No. PCT / US2013 / 050698, filed on July 16, 2013, all of which are incorporated by reference.
Stabilization structures of Figures 4A to 5E
Figures 4A to 4D illustrate different views of one embodiment of a stabilizing structure 1701. The stabilizing structure may be oriented in any direction when placed on a wound, but more preferably it will be oriented to preferably fold in a horizontal plane. The stabilization structure 1701 can be suitably sized to fit within the footprint of a wound dressing, so that the structure shown in Figures 4A to 4D may comprise only a portion of the stabilization structure used in the wound dressing, or in such a way that only a part of the structure shown in Figures 4A to 4D can be used in the wound dressing.
Here, stabilization structure 1701 comprises a first set of beams 1703 that are rigidly or semi-rigidly attached or attached to a second set of intersection beams 1705. These beams 1703, 1705 form a flat support structure 1702 that is preferably substantially rigid within a plane. Beams 1703, 1705 can be at right angles to each other (although other configurations, eg honeycombs are possible). Two or more flat support structures 1702 can be joined together to form stabilization structure 1701, and each flat support structure 1702 is preferably separated from each other by spring elements 1711 and 1713, which are described in more detail below. . The number of flat support structures 1702 used in the stabilization structure can be adapted in relation to the size of the wound. For example, there may be 2, 3, 4, 5, or more flat support structures 1702 arranged parallel or substantially parallel to each other. The spring elements 1711, 1713 are preferably arranged to allow compression of the stabilizing structure 1701 in one direction to bring the flat support structures 1702 closer together. In a preferred embodiment, stabilization structure 1701 can collapse to 40% or less of its original size, preferably 30% or less of its original size; more preferably, 20% or less of its original size; even more preferably, 10% or less of its original size. In some embodiments, stabilization structure 1701 may collapse to 5% or less of its original size.
The spring elements 1711, 1713 are preferably elastically flexible and biased to be elastically foldable along a direction perpendicular to the plane defined by the flat support structure 1702. In some embodiments, the elements 1711, 1713 may be non-elastic , and retain their shape when folded. In such embodiments, the spring elements or stabilizing structure can be constructed with a ratchet mechanism that maintains the spring elements 1711, 1713 in their folded configuration.
In a preferred embodiment, these spring elements 1711, 1713 may be V-shaped or U-shaped. Each spring element may comprise two elongated portions that bend relative to one another and form an obtuse angle (as shown in the figures). 4A to 4C), or an acute angle (as shown in Figure 5A). Spring elements 1711 preferably run in a plane parallel to beam 1705, and can be attached to beam 1703 or beam 1705. Similarly, spring elements 1713 preferably run in a plane parallel to that of beam 1703, and can be attached to beam 1703 or 1705. For both spring elements 1711, 1713, a preferred point of attachment is at the union between beams 1703 and 1705. Preferably, the spring elements 1711 are arranged in a first plurality of parallel planes, extending parallel to the direction of the beam 1705, and the spring elements 1713 are arranged in a second plurality of parallel planes that extend parallel to the direction of the beam 1703. Spring elements 1711 located between two adjacent flat support structures 1702 can be arranged in a repeating pattern within the first plurality of parallel planes. Spring elements 1713 located between two adjacent flat support structures 1702 may be arranged in a repeating pattern within the second plurality of parallel planes. In an embodiment as illustrated in Figures 4A and 4C, the adjacent spring elements 1711 and 1713 form a diamond shape. However, different models, arrangements and numbers of spring elements can be used. In some embodiments, the spring elements 1711, 1713 may have an elasticity constant ranging from 10 to 30 N / m, more preferably from 15 to 25 N / m, and even more preferably 23 N / m. In some preferred embodiments, the force required to compress seven spring elements by 15 mm is equal to 250 g. In some embodiments, the force required to compress the same seven springs by the same distance ranges from 180 to 230 g. In some modes, there are a total of four spring elements 1711, 1713 by 10 cm<sup>3</sup>. Of course, it will be recognized that factors such as spring constants and / or number of springs can be tailored to the particular type of tissue and wound closure desired, and that higher or lower spring constants or number of springs can be used.
Spacers 1707 and 1708 may be provided at the edges or along the outer faces of structure 1701, and may be configured to contact the skin surrounding a wound. In some embodiments, spacers 1707, 1708 may be extensions of beams 1703, 1705, or may be supplied separately. In some embodiments, spacers 1707, 1708 may be provided with hook or anchor elements configured to anchor tissue, such as skin tissues, placed in contact with them. Additionally or alternatively, hook or anchor elements attached to structure 1701 may be provided separately from or in place of spacers 1707, 1708. Preferably, the hook or anchor elements are configured such that they have a releasing force (once hooked into the tissue) that causes no or minimal pain to the patient while still allowing sufficient pulling force to be applied to it in order to allow the wound to close. Figures 5A to 5E illustrate different modality views of a stabilization structure 1201. This modality is similar in some respects and in function to the modality previously described in relation to Figures 4A to 4D, and share similar elements. The structure comprises beams 1203 and 1205 that form a flat support structure 1202 separated by spring elements 1211 and 1213. Spacers 1207 and 1208 can also be provided. Here, however, spring elements 1211 and 1213 are thicker and have portions that bend relative to one another at acute angles. Furthermore, compared to Figures 4A to 4D, structure 1201 has a larger volume and a greater number of spring elements 1211, 1213. As best illustrated in Figure 5D, spring elements 1211 form a repeating diamond pattern within a first plurality of parallel planes, with the diamond location being staggered between adjacent parallel planes. A corresponding pattern is used for spring elements 1213 with a second plurality of parallel planes. A similar configuration can be seen in Figures 4A to 4D.
Stabilization structures of Figures 6A to 14 and 25
Figures 6A through 6D illustrate additional embodiments of a stabilization structure 1100. Figure 6A shows a perspective view of one embodiment of a stabilization structure 1100. Here, stabilizing structure 1100 is preferably comprised of two or more interlocking strips (described in more detail below in relation to FIG. 6B) that extend in directions approximately perpendicular to each other, when they are in a substantially unfolded configuration . The stabilizing structure is preferably configured to collapse in one direction or along a foreground while remaining relatively rigid and resistant to folding in a direction perpendicular to the first direction or plane.
Figure 6B illustrates side views of a lower strip 1102 and an upper strip 1104 that can be used to make a stabilizing structure 1100, as the embodiment illustrated in Figure 6A. Each of the upper and lower strips 1102, 1104 are preferably configured to movably interlock with one another, for example through flanging grooves 1106 and 1108. One or more notches 1106 may be provided on an upper side of the bottom strip 1102, and similarly, one or more notches 1108 may be provided on a bottom side of the upper strip 1104. When assembled together, the one or more strips Top and Bottom 1102, 1104 may be positioned such that notches 1106, 1108 are aligned. Preferably, the upper strip and the lower strip 1102, 1104 are positioned at substantially perpendicular angles to each other, thereby allowing the notches 1106, 1108 to form a groove together in order to create a movably interlocking structure. In general, the number of notches 1106 in the Lower strip 1102 will be equal to the number of upper strips 1108 that will form the stabilization structure 1100, and vice versa. The notches 1106, 1108 are preferably formed with a width that allows the strips 1102, 1104 to pass from angles of approximately perpendicular to angles far from perpendicular (i.e. near parallel) to each other, thereby allowing the structure of stabilization 1100 articulates and folds along one direction or plane.
In a preferred embodiment, strips 1102, 1104 are constructed of a rigid or semi-rigid material, such as a polymer. Examples of suitable polymers include polyethylene, polypropylene, polyurethane, polyvinyl chloride, polystyrene, pollacrylate, methyl polymethacrylate, PEEK, silicone, polyurethane, polycarbonate, composite and laminate materials, or combinations thereof. In some embodiments, the material may include compressed crosslinked foam or felt. Of course, other materials such as cardboard or metal can be used. Preferably, the materials can be at least partially porous in order to allow fluid to flow through the material. In addition, such properties can aid in the distribution of negative pressure through the device and to the wound, and can aid in the removal of fluid from the wound dressing. Such materials may include, for example, low-density polypropylene, foam material, or foam material. The material used does not necessarily have to be strong along the length of the strips 1102, 1104, but preferably must be able to withstand the pressure applied to a top or bottom edge. Preferably, the material is capable of withstanding pressure from atmospheric pressure exerted on a curtain when up to 200 mmHg of negative pressure is applied to the wound. In some embodiments, the material can withstand a force of 34.4 kPa applied to a top or bottom edge.
In a preferred embodiment, each strip 1102, 1104 is 180mm long by 30mm high. The thickness of the strips 1102, 1104 can vary, for example, between 1.50 to 2.40 mm, although the thickness will be selected at least in part based on the ability of the material to resist the pressure applied along its edge. The thickness is preferably balanced between keeping the material thin enough to minimize the compressed thickness of the stabilization structure 1000, while maintaining the thickness of the material enough to avoid causing excessive localized pressure on the wound bed. The notches 1106, 1108 can measure approximately 15 mm in height, and the notches can be separated from each other by 18 mm. Although notches 1106, 1108 are shown with rounded bottoms, they can also be cut with square or triangular bottoms. In some embodiments, the rounded edges reduce the stresses on the strips 1102, 1104 in order to prevent fracture and crack propagation, and may also increase the elasticity of the stabilizing structure 1100.
It will be understood that the interlock strips 1102, 1104 may not necessarily be attached to one another through notches. Hinges or other devices could be used to provide the articulation or movable interlocking ability illustrated above. In some embodiments, the hinges can be constructed from thinner areas of the same material used to construct the strips 1102, 1104, and are configured to flex or bend to a predetermined position. The stabilizing structure 1100 could also be molded as a single piece such that the interlocking strips 1102, 1104 form a single unit.
Returning to FIG. 6A, the perspective view illustrates an example of a configuration of stabilizing structure 1100 with multiple upper and lower interlocking strips 1102, 1104 movably interlocked through multiple notches 1106, 1108. The intersections of two upper strips 1102 and two lower strips 1104 form a quadrilateral gap 1109. When the top and bottom strips 1102, 1104 are angled perpendicular to each other, space 1109 will be square or rectangular. However, as the stabilizing structure 1100 collapses along one direction or plane, the gap 1109 will be more diamond or parallelogram. The stabilizing structure 1100 will preferably comprise several spaces 1109, which form cells defined by the walls of the upper and lower strips and with openings at the upper and lower ends.
Figure 6C illustrates a top view of one embodiment of the stabilizing structure 1100, where a porous material 1110 has been placed in the quadrilateral-shaped boundary space 1109. Here, the porous material 1110 used is preferably soft and conformable so that be able to adapt to any changes in the configuration of the 1100 stabilization structure if it is folded. Preferably, the porous material is a foam, such as a polyurethane foam. This porous wound filler material can be molded around the stabilizing structure 1100 in order to fully encapsulate it. When used, the resulting stabilizing structure 1100 can be cut to size in order to fit a wound. Such porous material 1110 can be used to aid in the transmission of fluid or fluid wick effect from within a wound, and may also, when in contact with the wound (eg, when used in pressure therapy wound refusal), aid in wound healing.
FIG. 6D illustrates a perspective illustration of one embodiment of stabilization structure 1100 with a porous wound filler 1110 inserted into gaps 1109. In some embodiments, the additional porous material can also be used to encapsulate or surround the structure 1100. For example, a stocking or wrap may be fitted around structure 1100, and may, for example, be constructed from foam or gauze. When the stabilization structure 1100 is incorporated as part of a wound dressing placed on the skin surrounding a wound, the structure may be oriented to coincide with landmarks on the skin or the shape of the opening or incision in the skin.
Advantageously for some types of wounds, the stabilizing structure of Figure 6A can be elongated in a direction perpendicular to the main closing direction, but still within the horizontal plane. Such lengthening may be beneficial for wound healing as wound physiology may dictate that it should lengthen as it is closed.
In use, the stabilizing structure 1100 can be placed on a wound such that the upward-facing portion of structure 1100 is substantially rigid and resists folding in the vertical direction once negative pressure is applied to the wound (for example , once covered by a cloth as described above). A porous material such as a foam can be placed around, in, and / or to surround or encapsulate the stabilizing structure 1100. When negative pressure is applied, structure 1100 will then preferably collapse in the plane perpendicular to the vertical direction, aiding in wound closure.
Figures 7A to 7C illustrate embodiments of a stabilization structure 1100 similar to that described above in relation to Figures 6A to 6D. Here, the stabilizing structure 1100 is constructed from interlocking strips constructed from felt foam. The physical relationship between and the mechanism for the upper and lower locking strips 1102 and 1104 are substantially similar to what was discussed above, and will not be repeated here. Felt foam, however, is foam (eg, polyurethane foam) that has been heated and compressed. After this procedure, the foam will be stiffer and less compressible, while still remaining porous. Such a material can be advantageously used in a stabilizing structure 1100, since the material can be compressible in a plane defined by the upper and lower strips 1102, 1104, as shown in Figure 7B. However, the material is substantially rigid in the vertical direction, as illustrated in Figure 7C, when a weight has been placed on the foam without substantial buckling. Here, the foam can withstand approximately 6 kg of weight, and device modalities have been measured to withstand at least 20.6 kPa of applied pressure without collapsing. Furthermore, while such material is substantially rigid, the porous nature of the material allows the negative pressure that is transmitted to the wound and for wound exudate to be removed.
Figures 8A to 8B are photographs of additional modalities of stabilization structures. FIG. 8A illustrates one embodiment of a stabilizing structure 1301 that preferably folds along one direction. Here, stabilization structure 1301 comprises a porous material (eg, foam) into which one or more grooves 1303 have been cut. These grooves 1303 preferably extend longitudinally through the thickness of the stabilizing structure 1301. Accordingly, the void space will allow the stabilizing structure to preferably fold in one direction when a force is applied in a direction perpendicular to the grooves 1303. Because the gap is easier to compress than the rest of the foam, the width and thickness of the foam will preferably not (or minimally) be compressed compared to the resulting compression perpendicular to the length of the stabilization structure 1301 .
As illustrated in Figure 8B, the stabilization structure 1301 can also be provided with holes or cells 1305 in other configurations, such as diamond-shaped holes that form a lattice. This configuration allows compression along the length and width of the stabilization structure, due to compressible holes 1305, while the comparatively stiffer thickness of the foam resists compression to a greater extent.
In some embodiments, stabilization structures similar to those illustrated above in Figures 6A to 6D can be constructed as a single unit, for example by molding, rather than multiple parts. As with the modalities described above, stabilization structures are configured to form a series of one or more cells defined by one or more walls and forming a plane, with each cell having an upper and lower end with an opening that it extends through the upper and lower ends in a direction perpendicular to the plane. In some embodiments, the stabilizer structures may have cells that are square, diamond, oblong, oval, pellet, and / or parallelepiped, and the non-limiting examples thereof are illustrated elsewhere in the specification. While some modes can have cells that are all the same shape, cells can also be adapted to be larger, smaller, or differently than other cells in the structure. The shape and size of the cells can be adapted to the desired characteristics (for example, resistance and ease of folding) for wound closure and optimal healing.
The construction of a single unit stabilization structure can be advantageous in terms of ease of use and cost. For example, individual unit stabilization structures can be trimmed as needed to fit a wound site. The material used is preferably biocompatible, and even more preferably non-adherent to the wound area. Suitable materials are preferably chosen to be soft while still being strong enough to resist creasing in a vertical direction, and may include polymers, such as polyethylene, polypropylene, polyurethane, silicone (including siloxanes), ethyl vinyl acetate , and copolymers and mixtures thereof. The hardness of the material can affect the thickness of the resulting stabilizing structure, and can be selected based on the desired thickness of the components of the stabilizing structure (including hinges and other hinges thereof) and the capacity of the stabilizing structure. to resist the fold, for example, due to atmospheric pressure acting on a cloth placed on the stabilization structure. The suitable durometer hardnesses of materials used vary from about 30 shore to 120 shore (measured on the Shore A type scale durometer), preferably from about 40 shore to 60 shore, and even more preferably from about 42 shore. Generally, the chosen material is preferably softer (while still satisfactorily meeting other material requirements), as harder materials can provide reduced levels of closure as hardness increases.
Figures 9A to 9B illustrate one embodiment of a stabilizing structure 1100 configured to preferably fold only in a horizontal direction while remaining substantially rigid or unfolded when the force is applied in a vertical direction. Preferably, the stabilizer structure 1100 is constructed as a single unit, as illustrated in order to form one or more cells 1131. Here, two or more longitudinal strips 1120 (which form the cell walls) may have relatively straight configurations, and are connected to each other through one or more folding cross strips 1122. It will be appreciated that, in a single unit embodiment, the Strips are simply portions of the same material that may have been formed together to form the complete single unit structure. The collapsible cross strips 1122 may be angled or dented in order to increase the likelihood that they will sink in a direction generally parallel to their length. In this embodiment illustrated in this section or elsewhere in this specification, the foldable cross strip 1122 is more likely to fold at the apex of the angled part and at the joints to longitudinal strips 1120 when a force is applied to a direction approximately parallel to the overall length of the foldable cross strip 1122. In some embodiments, the collapsible cross strip is configured to fold into a part (which may be thinner) of longitudinal cross strip 1120.
In some configurations, one or both of the longitudinal strips 1120 and / or collapsible cross strips 1122 may comprise one or more notches placed along a length thereof. These notches promote fluid transfer through the structure, and aid in the distribution of negative pressure. In some embodiments, the notches can be used in conjunction with a porous material in order to improve fluid transfer. Relative to the longitudinal strips 1120, the collapsible cross strips 1122 may alternatively be located along the length of the longitudinal strips 1120, as best illustrated in Figure 9B, to form a configuration somewhat analogous to a lock used in brickwork. Of course, other configurations are possible. Furthermore, although this embodiment is illustrated as being formed as a single unit, those of skill in the art will recognize that this embodiment (and the others described below) can be constructed from multiple pieces attached or connected to one another.
FIG. 10 illustrates another embodiment of a stabilizing structure 1100, here comprising two or more longitudinal strips 1120 joined together through one or more transverse angled strips 1124 to form cells 1131. As with the embodiment illustrated elsewhere in the specification, the stabilizer structure 1100 is configured to fold when pushed in a direction perpendicular to the length of the longitudinal strips 1120, while remaining substantially rigid or unfolded when the Force is applied in a vertical direction. The angled cross strips 1124 are preferably joined to the longitudinal strips 1120 in order to form a non-perpendicular angle in order to promote the folding of the stabilizing structure 1100 in the direction perpendicular to the length of the longitudinal strips 1120. As is With Figures 9A to 9B, one or more notches may be formed on one or both longitudinal strips 1120 and / or angled cross strips 1124.
Figure 11 illustrates a single unit stabilization structure 1100 comprising one or more pairs of curved longitudinal strips 1126. Each Individual longitudinal strip 1126 can be formed as a corrugated strip (when viewed from a vertical orientation) which, when joined Face to face, they form one or more circular or ovoid cells 1127. As with the other stabilization structures illustrated in this section or elsewhere in this specification, this structure 1100 is configured to preferably fold along a plane or horizontal direction while remaining substantially rigid or unfolded when the Force is applied in a vertical direction. Although structure 1100 is illustrated here as formed from a single unit, the structure may be constructed from two or more curved longitudinal strips 1126 welded or joined together at the points shown. As with other modalities described in this section or elsewhere in this specification, one or more notches may be made in the walls in order to aid fluid transfer through structure 1100.
FIG. 12 illustrates a stabilization structure 1100 similar to that illustrated in FIG. 11. Here, however, the longitudinal zigzag strips 1128 are joined to form diamond-shaped cells (rather than circular or ovoid) 1129. It will be Of course appreciated that this embodiment can also be manufactured using substantially straight strips in a style similar to the modalities illustrated in Figures 6A to 6D.
Figure 13 illustrates a stabilizing structure 1100 comprising vertical segments 1130 joined at approximately perpendicular angles to form quadrilateral cells or square cells 1131. Preferably, vertical segments 1130 are square or rectangular in shape, with edgers 1132 They link the segments together in a flexible, mobile configuration. As with the other modalities described in this section or elsewhere in this specification, this stabilization structure 1100 can be manufactured as a single unit, and is preferably configured to collapse in a plane or horizontal direction while remaining substantially unfolded into one vertical direction.
FIG. 14 illustrates another stabilization structure 1100 similar to the embodiment illustrated above in FIG. 13. The vertical segments 1130 are preferably joined together to form one or more quadrilateral or square-shaped cells 1131. Here, without However, the vertical segments 1130 do not comprise a conical part 1132. However, one or more notches may be present on the bottom (wound facing side) of structure 1100, and they function as described in the above embodiments. Although this embodiment can be made from several vertical segments 1130, they are preferably molded as a single unit.
In some embodiments, the stabilizer structures described in this section or elsewhere in this specification may be fully molded from a single type of material, such as a plastic. In other embodiments, the stabilizer structures described in this section or elsewhere in this specification can be constructed through an overmolding procedure whereby the stiffer portions of the structure are molded first and the hinges or flexible portions are molded afterward. . In additional embodiments of the stabilization structure described in this section or elsewhere in this specification, a soft polymer is molded over the entire structure to soften the feel of the device. In other embodiments, the soft polymer could be molded only on the Bottom of the stabilization device, while in some embodiments the softer polymer could be molded on the top and / or sides of the device. In some embodiments, the soft polymer could be molded onto particular edges of the stabilization structure, such as those at the bottom, sides, and / or top. In certain embodiments, the soft polymer could be molded onto either side or combination of sides of the stabilization device. The soft polymer can act as a softened edge that surrounds the hard edges of the stabilization structure.
Figure 25 illustrates an embodiment of a stabilization structure 3800 similar to the structures described above. In this embodiment, the longitudinal strips 3802 and the transverse strips 3804 are formed from a single piece of material and form rows of flexible cells 3806 that are configured to fold in a horizontal plane. Because each of the longitudinal and transverse strips are formed from the same flexible material, applying a lateral force to the structure causes the cells to generally fold independently of each other. In other words, the folding of one or more cells in one row does not necessarily cause the folding of other cells in the same row.
Stabilization structures of Figures 15A to 21B
FIG. 15A is a photograph of one embodiment of a stabilization structure 2100 that can be placed over a wound and incorporated into a wound dressing. Here, the device comprises a plurality of cells 2102 provided side by side in a generally flat configuration. Preferably, the stabilizer structure 2100 is configured to fold in one direction along a plane 2101 defined by the width of the device, without significantly folding in a direction perpendicular to plane 2101. That is, when seen in the figure, the stabilization structure 2100 will collapse in the horizontal direction, but will not compress in the vertical direction. In some embodiments, the stabilizing structure folds in conjunction with tissue movement. Here, cells 2102 are preferably open at both ends in a direction perpendicular to plane 2101.
Each of cells 2102 is preferably formed with four walls 2104, each wall 2104 being joined to the next by a flexible joint 2106. Joints 2106 are preferably designed to be more flexible than walls 2104, and to promote the folding of the stabilization structure 2100 in the direction of the plane. Of course, it will be understood that other configurations are possible, and in some embodiments each cell 2102 can be defined by less than or more than four walls 2104, for example five or six wall walls, thus forming pentagonal or hexagonal cells. Cells 2102 may not necessarily be symmetrical, and may have a rectangular, diamond, rhomboid, trapezoidal, parallelepiped, oblong, oval, wafer, and other shape in addition to the square wall mode illustrated in this section or elsewhere. in this specification.
One or more of the walls 2104 defining the one or more cells 2102 may further comprise an insert 2115 arranged therein, and described in greater detail below in Figures 16A to 16F. Preferably, insert 2115 is constructed from a more rigid material than the material used to construct the rest of wall 2104. Some suitable materials may include metals such as titanium, stainless steel, and largely inert alloys (such as monel and hastelloy), and / or polymers such as polyurethane, silicone, rubber, isoprene, polyethylene, polypropylene, nylon, polyacrylate, polycarbonate, and PEEK. Some embodiments may also comprise composites, including resin fiber reinforced composites where the resin may be, for example, various types of epoxy resins. Suitable fibers can include glass, carbon, carbon nanotubes, graphene, and aramides (eg Kevlar). Preferably, the material chosen for Insert 2115 is not only sufficiently rigid, but also capable of adhering to the material used in wall 2104. For example, the Insert material is preferably capable of adhering to softer polymers such as silicone or polyurethanes used in wall 2104. Stiffer materials used in insert 2115 may provide additional kink resistance in the direction perpendicular to the plane of the stabilization structure 2100.
In some embodiments, one or more notches 2109 may be provided between multiple walls 2104, and which may further assist in allowing flexible joints 2106 to move. Without wishing to be bound by theory, notches 2109 can also assist in negative pressure distribution and fluid transmission along stabilization structure 2100 when negative pressure is applied, for example, in a clinical care setting. Some embodiments may also comprise holes in walls 2104 or joints 2106, or be constructed from porous materials.
Preferably, a cavity 2108 is provided within each wall 2104 for Insert 2110 to be disposed therein. Walls 2104 can be molded around each insert 2115. An Insert 2115 can also be Inserted into cavity 2108 after wall 2104 is manufactured. Although the modality illustrated here and in the subsequent Images shows a single Insert 2115 on each wall 2104, some modalities may be provided with one or more Inserts 2115 arranged inside.
Figure 15B illustrates one embodiment of a stabilization structure 2100 with many features similar to Figure 15A. Here, an Insert 2111 comprises structural differences compared to insert 2110, and is discussed in more detail below in relation to Figure 15E. When inserted or positioned within cavity 2108, one or more of walls 2104 may comprise a hole 2105 that communicates through at least one opening in insert 2111. In addition to any notches 2109, the one or more holes 2105 may allow for additional displacement of wound exudate and the distribution of negative pressure within stabilization structure 2100.
FIG. 15C illustrates one embodiment of a stabilization structure 2100 with characteristics similar to the other embodiments described above. In this embodiment, the stabilization structure 2100 comprises an Insert 2112 described in greater detail below in Figure 16F.
Similarly, FIG. 15D illustrates one embodiment of a stabilizing structure 2100 comprising an Insert 2113 described in greater detail below in FIG. 16D. FIG. 15E illustrates one embodiment of a stabilizing structure 2100 comprising an Insert 2114 described in greater detail in connection with FIG. 16A.
In the above modalities of stabilization structure 2100 comprising various inserts 2110, 2111, 2112, 2113, 2114, and 2115, of course, it will be understood that the modalities of stabilization structure 2100 need not contain only one type of insert. Similarly, each cell 2102 or wall 2104 may comprise one or more different types of inserts, or no inserts at all. Variation of the different inserts and other properties of cells 2102 and walls 2104 can thus allow stabilization structure 2100 to be tailored for the appropriate type of wound in order to effect optimal wound closure and / or treatment.
Figures 16A through 16F illustrate examples of different inserts that can be used as part of a stabilizing structure 2100. Preferably, these inserts can be placed, molded into, or formed as part of a wall 2104 in a stabilizing structure 2100 (by example, of the types illustrated above in Figures 15A to 15E). Various modifications can be made, as described below, that can improve or alter the characteristics of the inserts.
Turning now to Figure 16A, the embodiment of the insert 2114 illustrated here is approximately rectangular in shape, and is adapted to be inserted or formed into one or more of the walls 2104 of one embodiment of the stabilization structure 2100. In some embodiments, one or more of the inserts 2114 may have a height greater than the width, and the wall 2104 may have a height of at least about 1mm, at least about 5mm, at least about 10mm, at least about 15mm, at least about 20mm, at least about 25mm, at least about 30mm, at least about 35mm, at least about 40mm, at least about 50mm, at least about 75mm, at least about 100 mm, at least about 150 mm, at least about 200 mm, at least about 250 mm, at least about 300 mm, at least about 350 mm, at least about 400 mm, or more than 400 mm, in particular in extremely obese patients. Preferably, in average patients, heights can range from about 10mm to 40mm. These measures can be applied to any stabilization structure described in this section or in other parts of this specification.
In some embodiments of any stabilization structure described in this section or elsewhere in this specification, the width may be between approximately 1mm to 30mm, 2mm to 25mm, 4mm to 20mm, 6mm to 18mm. .8mm to 16mm or 10mm to 14mm, preferably about 10.8mm. These measures can be applied to any stabilization structure described in this section or in other parts of this specification.
Insert 2114 is preferably thin but with sufficient structural strength to resist bending, and in some embodiments of any stabilizing structure described in this section or elsewhere in this specification, the thickness may be at least about 0.01mm to 10mm, 0.2mm to 8mm, .4mm to 6mm, 4mm, 5mm to .75mm, 3mm or 1-2mm. These measures can be applied to any stabilization structure described in this section or in other parts of this specification. .
In some embodiments of any stabilization structure described in this section or elsewhere in this specification, multiple discrete stabilization structures can be stacked on top of each other to form a larger stabilization structure, to extend the height of the device from either the dimensions described in this section or elsewhere in this specification (Including the dimensions provided in the previous Inserts). Stacking multiple stabilizing structures can allow the clinician more flexibility in their treatment strategies.
Figure 16B illustrates an embodiment of insert 2110 with a generally rectangular configuration, but provided with two notches 2201 cut diagonally through an upper end of Insert 2100. Notches 2201 can facilitate removal of Insert 2100 from any notches 2109 that may be provided on walls 2104. In addition, notches 2201 may also assist in inserting insert 2100 into cavity 2108 of wall 2104. Notches 2201 may also be useful in combination with notches 2109 in defining more than one channel or other opening for fluid to be transmitted or transferred between and through each cell 2102. Notches 2201 can also help ensure that The entire stabilization structure is able to fold more easily.
FIG. 16C illustrates one embodiment of an insert 2115 provided with two notches 2201, as well as a horizontal lip 2203. Horizontal lip 2203 may assist in the insertion of insert 2115 into cavity 2108 of wall 2104, or may assist in fixation wall 2104 around insert 2115 when the wall is molded around it. The horizontal lip 2203 can be beneficial in effectively reducing most of the Insert at one end of the 2104 wall, and in conjunction with a softer material used in the 2104 wall, thereby increasing comfort due to the corresponding more wall material. In some embodiments, horizontal lip 2203 and / or notches 2201 may be present at both ends of insert 2115 or other inserts described in this section or elsewhere in this specification. In some embodiments, the horizontal lip 2203 is approximately half the thickness of the Global Insert 2115. For example, the insert 2115 may be between 0.5mm and 4mm thick, preferably 2mm. If the insert 2115 is 2mm thick, the thickness of the horizontal lip 2203 may be 1mm.
FIG. 16D illustrates one embodiment of insert 2113, and which is similar to the embodiment used in stabilization structure 2100 illustrated in FIG. 15D. This insert 2113 can comprise one or more openings 2205, which in some embodiments can communicate with one or more holes 2105 that can be formed through one or more walls 2104. In some embodiments, openings 2205 are arranged in a 2x3 pattern! Shined here, although other arrangements are possible. Notches 2201 may also be present.
FIG. 16E illustrates one embodiment of the insert 2111, which is similar to the embodiment used in the stabilization structure 2100 illustrated in FIG. 15B. Insert 2111 preferably comprises two notches 2201. A horizontal lip 2203 may also be provided. Preferably one or more openings 2205 may be formed therein. In some embodiments, one or more of openings 2205 can extend to the edge of insert 2111 as illustrated. In some embodiments, openings 2205 may be configured to have four openings arranged around a central opening, although other configurations are, of course, possible. In some embodiments, the reduced amount of Insert material at the locations of the openings may be advantageous in providing a greater amount of softer wall material at a point of articulation, where this may consequently increase flexibility. In a preferred embodiment, the Insert 2111 has a height of 25 mm and a width of 10.8 mm, with a thickness of 2 mm. The first set of openings may be centered approximately 5mm from the Bottom edge of Insert 2111, the center opening may then be centered approximately 11mm from the bottom, and the upper set of openings may be centered 17mm from the Bottom .
Figure 16F illustrates an embodiment of Insert 2112, which shares some similarities with the embodiment used in stabilization structure 2100 illustrated above in Figure 15C. Insert 2112 may preferably comprise one or more channels 2207 formed therein. Preferably, the one or more channels 2207 are arranged in a horizontal configuration across the width of Insert 2112. Although Insert 2112 is preferably configured, like several other modalities described in this section or elsewhere in this specification, to remain substantially uncompressed in the vertical direction, the inclusion of one or more horizontal channels 2207 may help to provide rigidity. additional in the direction of the plane defined by cells 2102. In such a case, the stiffness of the one or more walls 2104 can be improved, and therefore can control the compression of the stabilizing structure 2100 such that any bending or flexing occurs substantially only at the one or more joints 2106.
Figures 17A through 17F illustrate one embodiment of a stabilizing structure 3001 configured to be applied to a wound and may be incorporated into a wound dressing. Stabilization structure 3001 preferably comprises at least one top strip
3002 extending in a first direction (eg, along an x-axis) and at least one Bottom strip 3004 extending in a second direction (eg, along an y-axis perpendicular to the x-axis), these preferably being arranged in an arrangement comprising multiple strips 3002, 3004. The strips 3002, 3004 are preferably connected in a moveable latching configuration, preferably comprising a latching mechanism 3006. The strips 3002, 3004 are preferably arranged in an unfolded configuration where the strips 3002 and 3004 are arranged at approximately perpendicular angles to each other. This arrangement forms a close-up that the stabilizing structure 3001 preferably adopts. Preferably, stabilization structure 3001 is stiffer in the direction perpendicular to the plane (ie, in the vertical direction or along a z-axis), and therefore substantially resists compression or deformation in that direction.
To assist in wound closure, stabilization structure 3001 is preferably movable from the substantially unfolded configuration to a folded configuration, as illustrated in Figure 17F. This can be beneficial for wound closure and healing, as described above. In use, the negative pressure can apply a closing force through the edges of the wound that the stabilizing structure 3001 inserts into these. As structure 3001 is preferably configured to be substantially rigid in the vertical direction (i.e., perpendicular to the plane defined by structure 3001), the pressure resulting from atmospheric pressure exerted on structure 3001 through the cloth is focused substantially downward rather than outward, such that the wound edges are no longer pushed outward as in conventional negative pressure bandages.
Preferably, structure 3001 adopts a smaller area in the foreground as a result of moving to the compressed configuration. In some embodiments, the stabilizer structures described in this section or elsewhere in this specification are able to reduce their captured volume when it is in a folded configuration (i.e., the change in volume between an uncompressed and compressed stabilization structure) by at least 10%, preferably at least 15%, and even more preferably at least 25%.
Figures 17C to 17E illustrate close-ups of the latching mechanism 3006. It should be noted that although various parts of the latching mechanism 3006 may be referred to as being present in the upper strip 3002 or lower strip 3004, this description should not be considered as a limitation in terms of orientation, and the same locking mechanism 3006 can be constructed with the upper and lower strips 3002, 3004 reversed.
In a preferred embodiment, the locking mechanism 3006 preferably comprises two latches 3010 that extend downward from the top strip 3002.
Preferably, the latches 3010 are parallel to each other in order to be on opposite sides of a projection 3012 extending upward from the bottom strip 3004. The latches 3010 preferably comprise a lip or hook 3011 that can be self-securing by virtue of of an end 3013 located at the distal end of projection 3012. In a preferred configuration, the enlarged end 3013 is arranged such that all or a portion of the lip 3011 engages with the enlarged end 3013. The combination of the lip 3011 and the extended end 3012 can assist in preventing the top strip 3002 disengages in a vertical direction away from the bottom strip 3004. In some embodiments, the projection 3012 may rest on the bottom edge of the top strip 3002. In some embodiments, however, and as illustrated herein, a stabilization post 3014 may be present to locate the distal side of the projection 3012 and the extended end 3013.
Figures 18A through 18D illustrate one embodiment of a stabilizing structure 3201 mounted in a similar manner to the embodiment previously illustrated in Figures 17A through 17F. Here, the interlocking mechanism 3006 is comprised of four locks 3010 surrounding the projection 3012 and the enlarged end 3013 of the projection 3012. Preferably, the locks 3010 are arranged in a mutually orthogonal configuration, although different orientations are also contemplated. It will be understood that any number of locks 3010 can be used to secure the projection 3012, for example three or five locks 3010.
It will be appreciated that due to the addition of additional closures 3010 compared to the embodiment illustrated in Figures 17A through 17F, the embodiment illustrated here will have a compressed configuration that is slightly larger, as illustrated in Figure 18D. This can be useful in some situations; for example, some wounds may require a more gradual closure of the wound margins, and the modality described here may be well suited for this purpose.
Figures 19A through 19E illustrate one embodiment of a stabilizing structure 3301 comprising a locking mechanism 3006 arranged in a tubular conformation. In this embodiment, a cup-shaped member 3020 is preferably configured to receive the enlarged end 3013 of projection 3012. Projection 3012 may extend vertically from top strip 3002. Cup-shaped member 3020 is preferably cylindrical or tubular in shape, and may extend vertically from bottom strip 3004, although it will be understood that cup-shaped member 3020 and projection 3012 may be located on opposite strips.
Preferably, one or more grooves 3021 are formed in the cup-shaped member 3020 in order to allow some space to allow the projection 3012 to be received within the cup-shaped member. A lip or hook 3022 can also assist in securing the enlarged end 3013 of the projection 3012. A stabilization post 3014 may also be present to prevent the projection 3012 from extending too deeply into the cup-shaped member 3020.
Figure 19E illustrates a compressed view of one embodiment of stabilization structure 3301. Compared to Figure 17F, this embodiment has a slightly larger compressed configuration.
Figure 20 schematically illustrates one embodiment of a stabilization structure 5100 configured to be placed over a wound and to be incorporated into a wound dressing. Preferably, stabilization structure 5100 preferably comprises at least one, and more preferably at least two, long strips 5102 whose longitudinal length may be oriented along a longitudinal axis of a wound, or along a direction thereto. along which the closure is sought. Each of the one or more long strips 5102 are preferably substantially rigid and extend substantially along the entire length of a wound. In a preferred embodiment, long strip 5102 is continuous and has no breaks or hinges along its length. This is in contrast to certain other modalities described above.
One or more struts 5104 are preferably attached at one or more points along the strip 5102. Preferably, these struts 5104 are movably attached, for example through a hinge or flexible joint connection, so that they can folded in a direction perpendicular to a longitudinal length defined by the length of one or more long strips 5102. In some embodiments, struts 5104 may be angled at a non-perpendicular angle to long strip 5102 in order to more easily fold. In embodiments comprising two or more long strips 5102, struts 3404 may be articulating between two parallel long strips 5102.
It will be recognized that while these struts 5104 may be configured to fold along a direction perpendicular to the longitudinal length of the one or more long strips 5102, the struts 5104 are preferably rigid in a vertical direction (i.e. in the direction extending upward from a plane defined by the wound). As such, a combination of struts 5104 and long strips 5102 can thus form a stabilizing structure 5100 that is substantially rigid in a vertical direction while folding in a horizontal direction perpendicular to the longitudinal axis of long strips 5102 (i.e. , in the plane of the wound or the skin surrounding the wound).
Figure 21A illustrates a top view of one embodiment of stabilization structure 5100 cut into an oval shape. Preferably, the stabilization structure 5100 comprises a plurality of elongated strips 5102 whose longitudinal length may be oriented along a longitudinal axis of a wound, or along a direction along which closure is sought. Each of the plurality of elongated strips 5102 is preferably substantially rigid and can extend substantially along the entire length of a wound. A plurality of intervention elements are positioned between adjacent elongated strips 5102. These intervention members may be struts 5404 as described with respect to FIG. 20, preferably attached at one or more points to elongated strips 5402. The Intervention members may also be portions of elongated strips, as described with respect to Figures 18A through 19E above, extending perpendicular or at an angle to elongate strips 5102. The stabilization structure of Figure 21A may also comprise the modalities described with respect to Figures 15A to 16F.
Figure 21B illustrates a top view of one embodiment of a 5100 oval stabilization structure placed over a wound. This mode may have the same configuration as that described above with respect to Figure 21A. Additionally, 5106 foam can be inserted between and around the stabilizing structure.
Stabilization structures of Figures 22A to 24 and 26 to 27
In some embodiments, the folding of a stabilizing structure as described herein in this section or elsewhere in the specification may occur slowly, thereby applying increased longitudinal tension over a long period of time. In certain modalities, the folding and elongation of the structure can occur immediately after the application of negative pressure. In other modalities, the fold can occur in any case.
Figures 22A to 22C illustrate another embodiment of a stabilizing structure 3500. The stabilizing structure 3500 comprises a plurality of elongated strips 3502 arranged in parallel, and the longitudinal length of which can be aligned with the longitudinal axis of a wound. The stabilization structure further comprises a plurality of intervention members 3504 connected to the elongated strips 3502 by a plurality of joints 3506. As illustrated, the plurality of intervening members 3504 between adjacent elongated strips 3502 define a row of cells 3508 between each pair of adjacent elongated strips.
In some embodiments, the elongated strips 3502 are rigid. In certain embodiments, the elongated strips 3502 are semi-rigid. In particular embodiments, the elongated strips 3502 are flexible. In some embodiments, the elongated strips 3502 are compressible. As illustrated in Figures 22A through 22C, one embodiment comprises a plurality of strips that are rigid in a vertical dimension, but are also flexible and capable of flexing along their length.
In some modalities, Intervention 3504 members are rigid. In certain modalities the members of Intervention 3504 are semi-rigid. In particular modalities, the members of Intervention are flexible and / or compressible. As illustrated in Figures 22A to 22C, one embodiment comprises intervening the members in the form of equally spaced panels between adjacent strips, to define a plurality of cells with similar shapes (eg, diamond-shaped). In other modalities, Intervention members need not be equidistant. The Intervention members may be attached to the strips by gaskets 3506 in the form of a hinge (eg, a hinge or a more flexible piece of material between the strips and the Intervention members).
In some embodiments, the plurality of Intervention members 3504 are configured to float relative to the elongated strips 3502 and to collapse such that the elongated strips are allowed to fold relative to one another and are closer together. In some embodiments, gaskets 3506 are configured to float and fold in one direction. In certain embodiments, gaskets 3506 are configured to float and fold in both directions, comprising a total of 180 degrees of rotation with respect to elongated strips 3502. In certain embodiments, when the joints float, they float fully in order to rest the Intervention members 3504 against elongated strips 3502. In some embodiments, the joints do not fully buckle and the intervention members fail to rest against elongated strips 3502.
Preferably, in certain embodiments, by controlling the direction in which the plvotamlent occurs, the folded length of stabilization structure 3500 can be controlled. In particular embodiments, due to the stiffness of the elongated strips, the cells 3508 in a row between the adjacent elongated strips are configured to collapse together as the adjacent elongated strips 3502 are folded relative to each other. In some embodiments, one or more rows of cells 3508 between adjacent strips 3502 are configured to collapse in a first direction, and one or more rows of cells between adjacent strips 3502 are configured to collapse in a second direction opposite to the first direction. As illustrated in Figures 22A through 22C, the orientation of the cells in adjacent rows is alternated so that cells in a first row fold in a first direction, and cells in a next row fold in a second direction. opposite direction. Gaskets 3506 can be configured such that gaskets 3506 in adjacent rows fold in different directions.
By configuring the joints 3506 and / or cells of the stabilization structure to bend and fold in preferred directions, the length of the folded structure can be modified. The embodiment shown in Figures 22A through 22C will have a shorter folded length than a structure in which all rows of cells 3508 are configured to fold in the same direction. Thus, the folded length of the structure can be controlled depending on the orientation of the cells and the direction in which the intervention members fold between adjacent rows.
In Figures 22A through 22C, Intervention members 3504 in adjacent rows are generally aligned such that Intervention members connect to the elongated strips at approximately the same location on opposite sides of the strip and share the same joint site 3506. In other embodiments, the intervening members 3504 between a first elongated strip 3502 and a second elongated strip 3502 are offset relative to Intervention members 3504 between the second 3502 and adjacent third strip 3502. In these embodiments, Intervention members 3504 they are staggered in such a way that they do not share the same joint site 3506.
As shown in Figures 22A to 22C, the closed cell 3508 consisting of two intervention members and two sections of the elongated strips is a quadrilateral. In some preferred embodiments, the closed shape may be a square, rectangle, diamond, oblong, oval, and / or parallelepiped shape. In some embodiments, the closed shape is a rhomboid. In certain modalities, the closed form is a trapezoid.
In certain preferred embodiments, gasket 3506 can be configured to limit the Interval of movement of Intervention member 3504, and can be used to prevent Intervention members 3504 from becoming fully perpendicular to adjacent strips. Therefore, the hinge can be configured to pre-confligate Intervention members 3504 in a partially folded position. For example, a lip or other part of material in the joint can be used to limit the angular movement of the Intervention members. The lip or other part of the material can also prevent the joint from folding completely flat. In some embodiments, the joint may be configured to Prevent Intervention members from rotating 180 degrees along the plane formed by the strips.
In some embodiments, when the stabilizing structure 3500 is placed over a wound, the elongated strips 3502 are generally positioned parallel to the lateral edges of the wound. Preferably, the stabilization structure is configured such that the elongated strips are positioned parallel to the longitudinal axis of the wound. The straps can also be folded along their length and angled outwards. The stabilization structure can be cut to an appropriate size. In other embodiments, the elongated strips 3502 are positioned perpendicular to the edge of the wound, or cannot be oriented along any edge of the wound.
In the embodiments of Figures 22A through 22C, as well as in other embodiments of the stabilizing structures described in this section or elsewhere in this specification, the straps can be constructed from a material selected from the group consisting of saddle, rigid polyurethane plastic, semi-rigid plastics, flexible plastic materials, composites, block-compatible materials and foam. In some embodiments, the intervention members can be constructed from a material selected from the group consisting of silicone, polyurethane, rigid plastics, semi-rigid plastics, flexible plastics, composites, biocompatible materials, and foam. In some embodiments, the stabilization structure is surrounded by absorbent materials. In certain embodiments, the stabilization structure is surrounded by non-absorbent materials. In some embodiments, the material surrounding the stabilizing structure is foam. In particular embodiments, the spaces between the intervention members 3504 and the elongated strips 3502 are filled with foam.
Figures 23A to 23G illustrate an embodiment of a stabilizing structure 3600 that is similar to that described above in relation to Figures 22A to 22C. As illustrated in FIG. 23A, in some embodiments, stabilizing structure 3600 comprises a plurality of elongated strips 3602 connected by a plurality of engagement members 3604 at a plurality of joints 3606. As illustrated in Figures 23A through 23G, the plurality of intervening members comprise a plurality of bars 3604 connecting adjacent elongated strips and connected to the elongated strips at upper and lower joint locations. The plurality of joints in one embodiment comprises a plurality of pins 3606 connected to the bars and received in upper and lower vertical openings in strips 3602. Other types of gaskets are also contemplated, including ball gaskets. The bars are preferably at equal intervals in a row between the adjacent elongated strips, and may be offset or staggered in an adjacent row, such that in an adjacent row, the bars connect to the elongated strip at a location between the bars from the first row. In other embodiments, the intervening member may comprise a wire or other elongated structure configured to extend between adjacent elongated strips.
Preferably, as illustrated in the top view of Figure 23B and the front view of Figure 23C, in certain embodiments the pins cause the bars to protrude above the vertical top and vertical bottom of the elongated strips 3602 In other embodiments, the 3604 bars may be connected to the elongated strips so that they are flush with the vertical top and vertical bottom of the 3602 elongated strips. In other embodiments, the bars 3604 may be connected such that they lie below the vertical top of the elongated strips 3602 and above the vertical bottom of the elongated strip.
As illustrated in Figures 23A and 23C, seals 3606 may preferably comprise a plurality of stops 3608 configured to limit rotation of the bars relative to the strips. The stops can protrude vertically from the strips to limit the movement of the bars. For example, these stops can be used to prevent the bars from becoming fully perpendicular to the adjacent strips, and can be used to provide a preferential direction of collapse of the adjacent rows. As shown in Figure 23A, a first row can have angled bars in a first direction, and a second row can have angled bars in a second direction. In some forms of modality, there are two stops per bar on a given strip, to restrict movement in two directions. In other forms of embodiment, there is one stop or three or more stops per bar on a given strip.
Figures 23E to 23G illustrate stabilization structure 3600 in a folded configuration. Similar to the structures of Figures 23A through 23C and Figure 23B, Structure 3600 can be postcloned to collapse in a direction perpendicular to the longitudinal axis of the wound. As described above, the stabilization structure can be surrounded by or filled with an absorbent material such as a foam. In one embodiment, because the vertical space between the top and bottom bars of structure 3600 is open (as best shown in Figure 23C), elongated blocks of foam or other compressible material can be placed between adjacent strips to provide a desired compressibility as the structure folds.
Figure 24 illustrates an embodiment of a stabilizing structure 3700 that is similar to the structures described above in relation to Figures 22A to 22C and Figures 23A to 23G. In certain embodiments, the stabilizing structure 3700 can be folded in any manner described above. The elongated strip 3702 as illustrated is formed into two halves, and can be separated along line 3708. Intervention 3704 members may be in the form of panels as described above. The joints 3706 in the upper half of an elongated strip may comprise pins that are on opposite sides of the strip extending downward from the upper part of the upper half of the strip. The joints 3706 in the Lower half of an elongated strip may comprise pins that are on opposite sides of the strip extending upward from the Lower part of the Lower half of the strip. These pins can engage in vertical openings located at the four corners of the intervention member 3704. As the top and bottom halves come together, the pins can engage the panel openings. The upper and lower halves can be fixed by any number of mechanisms, such as with adhesive and mechanical connections.
In the embodiment of Figure 24, with the ability to separate the two halves of 3702 along line 3708, members 3704 can be easily removed or replaced. In some modalities, only some of Intervention 3704 members are removed. In certain embodiments, the alternating intervention members 3704 are removed. In certain preferred embodiments, the interventional members are preferentially removed to allow the stabilizing structure 3700 to collapse in a more appropriate controlled manner for a particular wound. For example, joints 3706 may have varying levels of resistance to rotation, allowing control over the crease of the structure by adding or removing intervention members 3704. In addition, stops such as those described in connection with FIG. 31A, may be incorporated into the structure or any other structure described in this section or elsewhere in this specification to further control collapse. In some embodiments, the intervention members are replaced or removed to maximize the folded length of the 3700 structure. In certain embodiments, the intervention members are replaced or removed to minimize the length of the folded structure 3700. In some embodiments, the intervention members are replaced or removed to achieve a desired length for the folded structure.
Figure 26 illustrates another embodiment of elongated strips 3900 that can be used to form a stabilizing structure. The first strip 3902 illustrated at the top of FIG. 26 may be an elongated strip having a plurality of spaced openings 3904 that extend along a central axis of the strip. The second strip 3906 illustrated at the bottom of FIG. 26 may have a plurality of spaced notches 3908 extending from the top and bottom edges of the second strip and separated by a middle portion. A plurality of the first strips 3902 and a plurality of the second strips 3906 can be mounted on a stabilization structure similar to that shown in Figures 6A, 6C and 6D, where the plurality of first strips 3902 are arranged in parallel with each other, and the plurality of second strips 3906 are arranged parallel to each other. The plurality of first strips 3902 and second strips 3906 are coupled to each other by the middle portions 3910 of the second strips positioned through the openings 3904 in the first strips, to position the plurality of first strips at an angle to the plurality of second strips. This structure is configured to collapse on a horizontal plane while remaining rigid on the vertical plane.
FIG. 27 illustrates an embodiment of a stabilization structure 4000 similar to the embodiment of FIG. 11 described above. A plurality of longitudinal strips 4002 can each be provided in the form of a corrugated strip which, when joined face to face, forms one or more circular or ovoid cells 4004. The entire structure can be folded into a substantially flat configuration, and can be contained within a 4006 roll. To use the stabilizing structure, a part of the structure can be unrolled and cut to a desired length. Preferably, as the stabilizing structure unwinds, it expands to its natural, unfolded configuration. It will be appreciated that other modalities of the stabilization structure, and not only modalities utilizing the corrugated strips of Figure 11, can be mounted in a rolled configuration.
Figure 28 illustrates another embodiment of a stabilization structure. In this embodiment, the stabilizing structure 4100 has an elongated shape, preferably an oval shape, where cells 4102 within the oval shape have a plurality of cells arranged in a plurality of concentric rings 4104. In the illustrated embodiment, a Central oval cell is surrounded by two oval shaped rings. Other modalities may include more than two oval shaped rings.
Stabilization structures of Figures 29A to 32B
Figures 29A to 29F illustrate modalities of a stabilizing structure 4200 that are similar to the modalities described above in relation to Figures 22A to 25. The stabilizing structure may comprise a plurality of elongated strips 4202 arranged in parallel, the longitudinal length of which may be aligned with the longitudinal axis when placed over a wound. The stabilization structure may further comprise a plurality of intervention members 4204 connected to elongated strips 4202 through joints 4206. In certain embodiments, the stabilization structure 4200 may be folded in any way described in this section or elsewhere. in this specification with or without the application of negative pressure. For example, the stabilizing structure can fold significantly more in one plane than in another plane. In some embodiments, the stabilization structure may be composed of any material that is described in this section or elsewhere in this specification, including: flexible plastic such as silicone, polyurethane, rigid plastics, such as polyvinyl chloride, semi-plastics. rigid, semi-flexible plastics, biocompatible materials, composites, metals, and foam.
The 4200 stabilizing structure and all the stabilizing structures and wound closure devices described in this section or elsewhere in this description can collapse on a variety of time scales in a dynamic manner. In certain modalities, most of the fold can occur within the first few minutes after applying negative pressure. However, after initial folding, the wound stabilization structure or closure device can continue to fold at a much slower rate, thereby applying increased longitudinal tension over a long period of time.
In some embodiments, the stabilizer structures described in this section or elsewhere in this specification may be placed over a wound over a period of time, and then removed or replaced with another stabilization structure. The stabilization structure can be individually removed and replaced, or a wound dressing incorporating the stabilization structure can be removed and replaced. For example, a stabilizing structure can be placed over a wound over a period of time, promoting wound closure by applying force to bring the edges closer together. After a period of time has passed, the stabilizing structure can be replaced by a stabilizing structure of a different size or folding capacity, for example a stabilizing structure of a smaller size or lower density. This procedure can be repeated over and over again. In some embodiments, the stabilization structure is configured to remain on the wound for at least about less than 1 hour, at least about 1 hour, at least about 2 hours, at least about 4 hours, at least about 6 hours, at least about 8 hours, at least about 12 hours, at least about 24 hours, at least about 2 days, at least about 4 days, at least about 6 days, at least about 1 week, at least about 2 weeks, at least about 3 weeks, or more than 3 weeks.
In certain modalities, up to 90% of the folding of the wound stabilization structure or closure device can occur within the first few minutes after the application of negative pressure, while the remaining 10% of the folding can take place slowly during a period of many minutes, hours, days, weeks or months. In other embodiments, up to about 80% of the fold, up to about 70%, up to about 60%, up to about 50%, up to about 40%, up to about 30%, up to about 20%, up to about 10%, or about 0 % of the crease will occur immediately within the first few minutes after applying negative pressure while the rest of the crease occurs at a much slower rate, as in the course of many minutes, hours, days, weeks or months. In other embodiments, the stabilization structure can be folded at a variable speed.
In some modalities, the entire fold occurs at a slower rate, while in other modalities the entire fold occurs almost immediately within the first few minutes. In additional modalities, the fold can occur at any speed and the speed can vary over time. In certain embodiments, the fold speed can be variably altered by adding and / or removing portions of the structure or by controlling the application of negative pressure and Irrigant fluid.
As illustrated in the perspective view of FIG. 29A and the top view of FIG. 29B, the intersection of intervention members 4204 and elongated strips 4202 can define a plurality of cells 4210. In certain embodiments, cells 4210 can be of any of the shapes and sizes described in this section or elsewhere in this specification, such as those described in relation to Figures 22A to 22C. For example, a cell can be in the shape of a square, a diamond, a rectangle, an oval, and / or a parallelepiped.
Joints 4206 are configured to allow intervention members 4204 to fold, similar to the joints described in Figures 22A to 22C and Figure 24. Joints 4206 can be configured to allow intervention members to fold in any way. as described in this section or elsewhere in this specification in relation to other embodiments, such as those described in relation to Figures 22A to 22C. For example, seals 4206 may be configured to allow or preferentially cause a first row of Intervention members 4204 to fold in one direction, while allowing or preferably causing an adjacent row to fold in another direction.
Elongated strips 4202 may alternatively comprise flex segments 4214 and support segments 4214. In a preferred embodiment, flex segments 4212 can be constructed from a flexible or semi-flexible material, such as silicone and / or polyurethane. However, any flexible or semi-flexible material may be suitable. Flex segments 4212 can flex in any direction, allowing the stabilizing structure to more easily fold in any direction, but particularly in the horizontal plane. In a preferred embodiment, the support segments 4214 can be constructed of a rigid or semi-rigid material such as polyvinyl chloride (PVC). However, any rigid or semi-rigid material may be suitable. In the illustrated embodiment, elongated strips 4202 comprise elongated strips of a first material, such as silicone and / or polyurethane, with a plurality of elongated inserts of a second, more rigid material 4214 embedded in the first material. Therefore, flex segments 4212 are the areas on elongated strips 4202 where the stiffest inserts are not located.
As illustrated in Figures 29A through 29D, support segments 4214 may be larger than flex segments 4212. In one embodiment, support segments 4214 may be approximately three times larger than flex segments 4212 (such how to span three cells 4210). In other forms of embodiment, the support segments 4214 may be the same size as the flex segments 4212. In additional embodiments, the flex segments 4212 may be larger than the support segments 4214. Alternatively, the lengths and widths of the individual segments of the elongated strips 4202 may be variable. For example, the height of the support segments 4214 can be reduced so that they do not extend from about the top to about the bottom of the stabilization structure 4200. In some embodiments, a smaller support segment could span approximately half the height of the elongated strip 4202. In certain embodiments, the support segment 4214 may be located at the top or the bottom portion of the elongated strip. Said modalities can be carried out by using an Insert of a second material that has a height smaller than the height of the first material that forms the elongated strip 4202.
In some embodiments, the support segment does not alternate with flex segment 4212 and instead, elongated strips 4202 are comprised entirely of support segments 4214 (eg, a silicone strip or other material with a stiffer insert). Embedded that extends from its full length, or just a stiffer material by itself.) Alternatively, the entire elongated strip 4202 may be comprised only of flex segments 4212 (eg, a strip made only of silicone or other more flexible material).
The elongated strips 4202 can be fabricated from a female mold which may further encompass the complete stabilization structure 4200. The support segments 4214 can be Inserted into the female mold, followed by an injection of a flexible polymer such as silicone and / or polyurethane for storage of support segments 4214 within the flexible polymer frame. The support segments 4214 can be inserted into the mold in any desired way or quantity, allowing for many potential variations of the stabilization device.
In additional embodiments, the support segments 4214 are insertable and / or removable from the elongated strips 4202, and can be Inserted and / or removed to alter the folding ability of the stabilization structure 4200. The support segments 4214 can be Inserted and / or removed from stabilization structure 4200 after it has been placed in a wound to variably control the folding of stabilization structure 4200. In such embodiments, the elongated strips 4202 can form pockets that are open on one side (eg, from the top) to allow insertion and removal of support segments 4214.
Figures 29C to 29D illustrate in greater detail an embodiment of an individual support segment 4214. The support member 4214 may be a flat, plate-like structure having a rectangular shape, with a length greater than its height, and two surfaces parallel. The support segment may comprise at least one notch 4220, preferably located at the top edge of the support segment. In another embodiment, the notch or notches may be located on the bottom or sides of the support segment. In additional modes, the first notch could have a corresponding Bottom notch. In certain embodiments, the notch could be configured to allow tear of the support segment in a transection line through the support segment. Notch or notches 4220 may advantageously provide flexibility to the structure. The 4220 notches can allow the stabilizing structure to flex more easily in the horizontal plane or in the vertical plane. Notches 4220 may further allow the stabilization structure to rotate in multiple planes. Notches 4220 can also improve fluid flow within stabilization structure 4200. In some embodiments, the support segment does not contain a notch and the uppermost edge is flat. Notch 4220 may be located elsewhere in the support segment, for example the Bottom edge or the sides. The shape of the notch may be a rounded triangle as in Figures 29C to 29D or any other similar shape.
Intervention members 4204 in some embodiments may comprise a first material 4216 with an Embedded Insert 4218 made of a stiffer material. An embodiment of the Embeddable Insert is illustrated in Figures 29E to 29F. In certain embodiments, Insert 4218 is placed within a female mold and a flexible polymer such as slllcona and / or polyurethane is injected around the Insert to bury Insert 4218 within a flexible polymer frame. Inserts 4218 can be inserted into the mold in any desired way or quantity, allowing for many potential variations of the stabilization device. In other embodiments, the first material 4216 may be in the form of a sleeve configured to receive Insert 4218. In addition, sleeve 4216 may be configured to allow removal of an Insert 4218, such as by providing an opening at the top. of the cuff. In a preferred embodiment, the first material 4216 is constructed of a flexible or semi-flexible material, such as slllcona and / or polyurethane. However, any flexible or semi-flexible material may be suitable. In a preferred embodiment, Insert 4218 is constructed of a rigid or semi-rigid material, such as polyvinyl chloride. However, any rigid or semi-rigid material may be suitable.
Figure 29E illustrates a front view of insert 4218, while Figure 29F illustrates a side view of Insert 4218. The Insert in one embodiment may be a flat, plate-like structure having a rectangular shape, with a height greater than its width, and two parallel surfaces. The Insert may comprise a 4222 dent. The dent is preferably located in the upper portion of the Insert, however, the dent 4222 can be placed on either side of the Insert, or at the Bottom. Dent 4222 can be configured in such a way that it helps to allow fluid to flow through the stabilizing structure by providing a flow path. The 4222 dent can improve the flexibility of the 4200 stabilization structure and be configured to allow more efficient folding of the 4200 stabilization structure.
In some embodiments, the stabilization structure 4200 of Figures 29A to 29B can be configured to Include perforations or removable sections that allow portions of the device to be separated from the rest of the device. For example, perforations can be incorporated into joints 4206 between various cells contained within stabilization structure 4200, allowing the removal of individual rows or cells to alter the shape of stabilization structure 4200. In some embodiments, such as described above in relation to Figures 29C to 29D, the sections can be separated along perforations or lines on the elongated strips corresponding to the notches 4220.
In some embodiments, inserts 4218 can be inserted into raw material 4216 in a variable number of intervening members 4204 to control the shape and crease of stabilizing structure 4200. In other embodiments, inserts 4218 can be inserted directly into the sleeves comprised of the first material 4216 within the intervention members 4204 to control the shape and folding of the stabilizing structure 4200.
For example, inserts 4218 may be present in at least about 5% of the intervention members, at least about 10% of the intervention members, at least about 15% of the intervention members, at least about 20% of the intervention members, at least about 25% of the intervention members, at least about 30% of the intervention members, at least about 35% of the intervention members, at least about 40% of the intervention members, at least about 45% of the intervention members, at least about 50% of the intervention members, at least about 55% of the intervention members, at least about 60% of the intervention members, at least about 65% of the intervention members, at least about 70% of the intervention members, at least about 75% of the intervention members, at least approximately 80% of the intervention members, at least approximately 85% of the intervention members, at least approximately 90% of the intervention members, at least approximately 95% of the intervention members, or approximately 100% of the intervention members.
In certain embodiments, a variable number of support segments 4214 can be buried within elongated strips 4202 to control the folding ability of stabilization structure 4200. In other embodiments, a variable number of support segments can be inserted into a bag. contained within elongated strips 4202 to control the folding ability of the stabilizing structure. For example, support segments 4214 may be present over at least about 5% of the total length of the elongated strips, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about
35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75% , at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the total length of the elongated strips.
In certain embodiments, inserts 4218 or support segments 4214 can be inserted and / or removed over time to variably control the fold of stabilization structure 4200. For example, although initially all available 4216 sleeves of the stabilization structure may contain an insert, after initial placement of the stabilization structure in a wound, additional 4218 inserts may be removed over time, thus causing the stabilization 4200 fold even more. The inserts can also be added to the stabilization structure after they are inserted into a wound, thereby decreasing the folding ability of the 4200 stabilization structure. Thus, the addition and / or removal of the 4216 inserts or 4214 support segments allows variable fold control of the 4200 stabilization structure. Similarly, support segments 4214 can be inserted and removed from the elongated strips over time to provide variable control over the fold of stabilization structure 4200.
In certain embodiments of the stabilization structures described in this section or elsewhere in this specification, such as in the 4200 stabilization structure as described in Figure 29A, the flexibility of the various sections of the stabilization structure is increased by thinning that section. For example, in certain embodiments, instead of using a flexible material for an elongated bending segment 4212 4202, instead of bending segment 4212 it may be constructed of a material similar to that used to construct support segment 4214. In this modality, since support segment 4212 is thicker than flex segment 4212 will not flex to the degree of flex that can be experienced by flex segment 4212. In certain embodiments, the complete stabilization structure 4200 can be constructed from a single rigid or semi-rigid material, but made to have different rigid and flexible portions by thinning out certain areas of the 4200 stabilization structure. In additional embodiments , 4206 gaskets can be thinned to allow greater flexibility compared to the surrounding sections. In certain embodiments, thinning a section of the stabilizing structure 4200 can allow the thinner portion to be more easily separated from the structure.
As described above and applicable to all stabilization structures or wound closure devices described in this section or elsewhere in the specification, a soft polymer could be molded onto the entire 4200 stabilization structure to soften the feel of the device, thus protecting the skin, organs and / or other tissues. In other embodiments, the soft polymer could be molded only over the bottom portion of the stabilization device 4200, while in some embodiments the softer polymer could be molded over the top and / or sides of the device. In some embodiments, the soft polymer could be molded onto particular edges of stabilizing structure 4200, such as those on the bottom, sides, and / or top. In certain embodiments, the soft polymer could be molded onto any side or combination of sides of the stabilization structure 4200. The soft polymer can act as a softened edge that surrounds the hard edges of the stabilization structure 4200.
Figures 30A through 30D illustrate multiple views of another embodiment of stabilization structure 4200, similar to the stabilization structures depicted in Figures 22A through 22C and 29A through 29E. As in the embodiment of the stabilization structure shown in Figures 29A to 29F, the stabilization structure 4200 comprises elongated strips 4202 and intervention members 4204. The elongated strips 4202 may comprise openings 4224 configured to allow fluid to pass through the elongated strips 4202. For the construction of openings, holes or other shapes can be drilled directly through the elongated strips 4202. In the illustrated embodiment and As further shown in Figures 30C and 30D, the elongated strips 4202 further comprise stiffer inserts 4214 as described above. In such embodiments, openings 4224 can be drilled through rigid inserts 4214 at locations on the strip where the inserts meet, as well as through flex segments 4212 where the inserts are not located. The openings can be configured to evenly distribute fluid throughout the stabilization device and / or direct fluid flow along a particular passage or direction. In other embodiments, the intervention members comprise openings, similar to the openings described in connection with the elongated strips.
Figures 31A to 31B illustrate modalities of a stabilization structure 4400, with functional and structural elements similar to the modalities of the stabilization structure depicted in Figures 29A to 29F. Similar to the other stabilization structures described above, stabilization structure 4400 comprises elongated strips 4402 and intervention members 4404. Elongated strip 4402 may be a single unit strip without different flex segments or support segments and further comprises notches 4414. In certain embodiments, elongated strip 4402 may be comprised entirely of rigid or semi-rigid materials, such as polyvinyl chloride . In other embodiments, the elongated strip 4402 may be comprised entirely of flexible or semi-flexible material, such as silicone and / or polyurethane. Similar to the modalities described in Figures 29A to 29F, the stabilization structure 4400 can be folded in any way described in this section or elsewhere in this specification within any time scale described in this section or elsewhere in this specification . Figure 31C depicts an embodiment of stabilization structure 4400 where elongated strips 4402 comprise notches 4414 and openings 4416 allow fluid passage.
Figures 32A to 32B illustrate modalities of the stabilization structure 4500 that are similar to the stabilization structures described above in connection with Figures 24 to 27. The stabilization structure 4500 comprises elongated strips 4502 and the Intervention members 4504. The members Intervention 4504 may further comprise windows 4506, configured to allow fluid passage. In some embodiments, all Intervention 4504 members may comprise windows 4506, however, in other modalities only the outermost Intervention members horizontally 4504 comprise windows 4506, while Interior Intervention members are similar to other modalities described in this section. or elsewhere in this specification.
In certain embodiments, at least about 5% of the intervention members comprise windows, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of Intervention members.
The elongated strip 4502 may further comprise a gap 4508, configured to allow the passage of fluid. The gap may extend almost the full length of the elongated strips 4502 or extend only a portion of the length of the elongated strip 4502.
Figure 32B illustrates one embodiment of a stabilizing structure 4500, where windows 4506 further comprise bars 4510. In certain embodiments, at least about 5% of the windows comprise bars, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35 %, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about
95%, or approximately 100% of the windows.
Figures 33A to 33C are photographs of modalities of stabilization structure 4200, similar to those modalities of a stabilization structure described in connection with Figures 29A to 32B, further comprising foam inserts 4800. Inserts 4800 may be constructed of any material described in this section or elsewhere in this specification, including flexible foams, semi-flexible foams, semi-rigid foams, and rigid foams and other porous or compressible materials. The stiffness of the 4800 Foam Inserts can be used to control the fold of the 4200 Stabilization Frame. For example, stiffer foams can prevent folding of stabilization structure 4200, while flexible foams can allow stabilization structure to fold more quickly and easily. Varying the flexibility / stiffness of the foams allows the structure to fold in any case as described in this section or elsewhere in this specification. In some embodiments, the overall density of the stabilizing structure and / or wound closure device can be altered by increasing or decreasing the amount of foam within the 4200 structure. By reducing the overall density, the structure will be more easily foldable. Therefore, the use of a lower density structure with less foam can allow for greater wound closure as the structure becomes more easily foldable. Conversely, using a higher density structure with more foam may be less collapsible. In other embodiments, the foam inserts comprise only a portion of the individual cells 4210.
In some embodiments, the foams may be configured to degrade or dissolve over time, thereby allowing the foam inserts to shore up the open stabilization structure initially, before later degrading or dissolving in a controlled manner to control the folding speed of the stabilization structure. In additional embodiments, the foam inserts can be impregnated with biologically active materials that can promote wound healing. For example, biologically active materials can be anti-inflammatory molecules, growth factors, or antimicrobials.
FIG. 33A is a photographic perspective view of stabilization structure 4200 in an open state whereby cells 4210 that do not contain foam do not fold. Figure 33B is a photograph of the upper part of the stabilization of structure 4200 where cells 4210 are in a folded state. FIG. 33C is a top view photograph of stabilization structure 4200 where some of the rows have alternate cells filled with foam inserts 4800 or without foam inserts 4210. In some embodiments, the foam inserts can be inserted into at least about 5% of the cells, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30% , at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the cells.
Foam or other porous material can surround the perimeter of the stabilizing structure or wound closure device. The stabilization structure or wound closure device can be configured to fold in any way as described in this section or elsewhere in this specification, for example by having a particular size and shape, or by comprising a certain volume of foam or other porous material within the cells of the structure. The stabilization structure or wound closure device can also be modified in any way described in this section or elsewhere in this specification in order to better adapt to the shape of the wound. After placement on the wound, the stabilization structure or wound closure device can be sealed by a fluid tight cloth. The fluid tight cloth may comprise a port configured for the application of negative pressure. A negative pressure source can then be connected to the port and negative pressure can be applied to the wound. The stabilization structure or wound closure device can be replaced over time by stabilization structures or wound closure devices of various shapes and sizes as desired to better promote wound healing.
The tissue anchors of Figures 34A to 34B
Figures 34A to 34B are modal photographs of an anchor layer 5700 comprising two types of fabric anchors 5702 and 5704. One or more anchor or anchor layers as described herein can be provided on any suitable surface of any structure of Stabilization described here to promote adherence to tissue. For example, one or more anchor or anchor layers can be provided on a skin facing surface of the stabilization structure. In certain embodiments, the fabric anchors 5702, 5704 may comprise anchors such as those produced by the Sailboat Industries, multiple lugs, and / or multiple hooks. Anchors such as those described in relation to Figures 34A to 34B or elsewhere in this specification can be used to hold or penetrate various tissues, such as skin tissues. Furthermore, the structure of the anchors can have various shapes depending on the fabric they are intended for penetration and fastening. For example, longer anchors can be used for weakly attached tissues, such as fat or connective tissue, while shorter anchors can be used for denser tissues such as muscle. Depending on the shape of the anchor, shorter anchors may be more desirable for softer fatty tissue, while longer anchors are used for denser tissue. Stiffer shank anchors can be used to penetrate denser tissues.
In some embodiments, the anchors may have bilateral tips that tend to fold after insertion into the tissue and yet expand when pulled in an opposite direction such that a certain pulling force can be applied to the tissue. The characteristics of the anchors or attachment mechanisms, and their resulting force profiles, can vary by a number of parameters, such as the length of the anchor, the shape of the attachment mechanisms, the structure of grip characteristics, the ) material (s) used for the bonding mechanisms, the relative flexibility / rigidity of the bonding mechanisms, and the spacing / density of the bonding mechanisms. Additional examples of suitable fabric anchors may include the Sailboat hook and loop configuration, barbs, hooks, nails, stakes, arrowheads, or any suitable shape. Similar to anchors, some surfaces can serve to hold tissue, such as skin tissue. For example, textured surfaces, such as rough sandpaper-like surfaces, or nano-textured surfaces that can facilitate tissue adhesion.
In embodiments, anchors 5702, 5704 may be suitable for fastening or adhering to the skin. Anchors can penetrate the outer layers of the skin, such as the stratum corneum and adhere. The anchors can be of various lengths for optimal skin penetration or attachment of other tissues. For example, the length of the anchors can be a maximum of approximately .Olmm, and a maximum of approximately .lmm, a maximum of approximately .2mm, a maximum of approximately .5 mm, a maximum of approximately 1 mm, a maximum of approximately 2 mm, maximum approximately 3 mm, maximum approximately 5 mm, maximum approximately 10 mm, maximum approximately 20 mm, maximum approximately 30 mm, at most about 40mm, at most about 50mm, at most about 75mm, at most about 100mm, or more than 100mm.
In some embodiments, the use of surface anchors can be used in combination with a surgical adhesive, providing a much stronger bond than the adhesive alone, and providing temporary adhesion while the adhesive is affixed. In some embodiments, the surgical adhesive can be added to the anchors themselves. In certain embodiments, the surgical adhesive can simply be applied between the anchors to coat at least a portion of the anchor layer. In additional embodiments, the anchors can be replaced with a surgical adhesive, and the surgical adhesive can act to anchor a device to the surrounding wound.
In certain embodiments, the anchors can be constructed from a variety of materials, including any of the materials described elsewhere in the specification, such as: synthetic or natural polymers, metals, ceramics, or other suitable materials. Anchors can be constructed from biodegradable materials such as biodegradable natural or synthetic polymers. Non-limiting examples of biodegradable synthetic polymers include: polyesters such as polylactic acid or polyglycolic acid, polyhydrides, and linear polymers with biodegradable linkages. In addition, the anchors can be constructed of biodegradable biological materials, such as autoloaded, allografted, and / or xenografted. In certain embodiments, the anchors can be constructed from any material described in this section or elsewhere in the specification. For example, anchors can be constructed from various polymers, such as silicone, or from metals such as stainless steel, aluminum alloys, or titanium alloys.
The bandages and wound systems of Figures 35 to 37
Figure 35 illustrates a cross-sectional view of a bandage 6000 for use in negative pressure wound therapy, similar to the bandages described in relation to Figures 1 to 3B. Although this figure illustrates a bandage having a particular shape, the construction of the layers can be applied to any of the modalities described here in this section or elsewhere in the specification. As this section or elsewhere in the specification will be described in greater detail here, in particular embodiments of the various components of the dressing may be optional. For example, the bandage may contain all of the layers and components described here in this section or elsewhere in the specification, or the bandage may contain only some of the layers.
In some embodiments, bandage 6000 comprises a release layer 6002, a wound contact layer 6004, a stabilization structure 6006, an acquisition distribution layer (ADL) 6008, an absorbent layer 6010, a darkening layer 6012 , and a support layer 6014. Bandage 6000 may be connected to port 6016, which is described in more detail in Appendix A. At least wound contact layer 6004, stabilization structure 6006, absorbent layer 6010, darkening layer 6012, and support layer 6014 may have properties described in greater detail in Appendix A, as well as or in instead of the properties described here in this section.
In certain modalities, the wound contact layer 6004, the absorbent layer
6010, blackout layer 6012, ADL layer 6008, and / or backing layer may be optional and may be incorporated or not incorporated into the bandage in any combination. As described in relation to Figures 1 to 2E, the bandage can be applied as a single unit comprising any of these optional elements and other elements such as the stabilizing structure. In certain embodiments and as previously described with respect to Figure 1, the wound dressings of Figures 35 to 36 can be provided as a single item with all selected optional wound dressing elements or combinations of elements, pre-connected and integrated into a single unit. In embodiments and as described in more detail below in relation to Figure 37, most optional elements can be removed and the stabilization structure can be placed directly on a closed wound and covered with a cloth or support layer.
It should be understood by a person skilled in the art that the shape of the bandages depicted in Figures 1 to 3B, 35 and 36 is not limiting. In other embodiments, the dressing may have a square shape, a lobed shape, an oval shape, a rounded shape, a diamond shape, a sacral shape, or any other shape suitable as desired for the treatment of a wound. Additional details regarding modalities of bandages with different shapes can be found in Appendix A.
It should further be understood by a person skilled in the art that the port and multi-layer design of the bandages described in Figures 1 to 3B and 35 is not limiting. In embodiments, the various layers of the bandage can be constructed from different materials, have different designs, or be attached to one another in various ways. Furthermore, the bandages depicted in Figures 1 to 3B and 35 may additionally comprise additional layers, structures and functions. Additional details on the many possible bandage modalities can be found in Appendix A.
Returning to Figure 35, in certain embodiments, the stabilization structure 6006 is similar to the stabilization structures described in connection with Figures 4A to 33C. As with the stabilization structures described above, the stabilization structure 6006 is configured to fold in any manner described here in this section or elsewhere in the specification. Furthermore, the stabilization structure 6006 may be constructed of any material or be of any design described here in this section or elsewhere in the specification, especially as it relates to the stabilization structures of Figures 4A to 33C. The stabilizing structure 6006 may be of any shape or size described here in this section or elsewhere in the specification, however, in some embodiments the height of the stabilizing structure is a maximum of 1mm, 3mm, 5mm, 10mm, 15mm, 20mm, 25mm, 30mm, 40mm, 50mm, or more than 50mm. An outer perimeter of stabilizing structure 6006 may be smaller or larger than the outer perimeter of the dressing layer placed above, for example, ADL 6010 and / or absorbent layer 6010. In some embodiments, the entire outer perimeter of stabilizing structure 6006 may be Inwardly spaced from the outer perimeter of the overlapping layer of 5mm, or about 5mm, or 2mm to 8mm, or about 2mm to about 8mm.
In certain embodiments, the foldability of the stabilization structure allows the dressing 6000 to fold in any manner described here in this section or elsewhere in the specification. As previously described in relation to Figures 3A to 3B, the bandage can be folded along different axes. As described above, the bandage can be folded over various time scales. In embodiments, the bandage can only partially fold, for example, a dimension of the bandage can be reduced by at least about 5%, 10%, 25%, 50%, 75%, or more.
In particular embodiments, the stabilization layer may further comprise tissue anchors, such as those described in connection with Figures 34A to 34B. In certain embodiments, the tissue anchors are only attached to discrete portions of the stabilization structure as needed. For example, tissue anchors may cover a maximum of approximately 5%, a maximum of approximately 10%, a maximum of approximately 20%, a maximum of approximately 30%, a maximum of approximately 50%, a maximum of approximately 75%, and a maximum of approximately 100 % of the exterior part of the stabilization structure. As previously described, tissue anchors may be particularly suitable for attachment to the skin. In some embodiments, the tissue anchors may be substituted or supplemented by an adhesive, such as those described here in this section or elsewhere in the specification.
In some embodiments, tissue anchors may be located on wound contact layer 6004 and / or support layer 6014. For example, tissue anchors may cover a maximum of approximately 5%, a maximum of approximately 10%, at most about 20%, at most about 30%, at most about 50%, at most about 75%, and at most about 100% of the wound contact layer and / or the support layer.
By placing the tissue anchors directly on the stabilization structure 6006, the stabilization structure can be attached directly to the skin, thus allowing the transmission of closing force from the stabilization structure directly to the skin and the wound. In particular embodiments, the tissue anchors attached to the stabilization structure penetrate through the wound contact layer into the skin. In some modalities of the dressing, the wound contact layer is removed, thereby allowing the tissue anchors or adhesives of the stabilization structure to interact directly with the surrounding skin. Some modalities may be required for the tissue anchors to be placed along the two edges of the bandage that runs parallel to the Incision to alleviate the tension in the tissue around the Incision. Additional examples of tissue anchors and stabilization structures can be found in patent application PCT / US2014 / 061627, filed on October 21, 2014 entitled NEGATIVE PRESSURE WOUND CLOSURE DEVICE, the entirety of which is incorporated herein by reference. .
Returning to Figure 35, bandage 6000 may optionally comprise a wound contact layer 6004 to seal bandage 6000 to the healthy skin of a patient surrounding an area of the wound. The wound contact layer can comprise three layers: a polyurethane film layer, a lower adhesive layer, and an upper adhesive layer. The upper adhesive layer can aid in maintaining the integrity of the bandage 6000, and the lower adhesive layer can be used to seal the bandage 6000 to the healthy skin of a patient around a wound site. The lower adhesive layer can also be used to seal bandage 6000 to tissue anchors. The polyurethane film layer can be perforated. Some embodiments of the polyurethane film layer and upper and lower adhesive layers may be perforated together after the adhesive layers have been applied to the polyurethane film. Pressure sensitive adhesives, such as sllicone, hot melt, hydrocolloid, or acrylic based adhesives or other adhesives, can be formed on both sides or, optionally, on a selected single side of the wound contact layer . In certain embodiments, the upper adhesive layer may comprise an acrylic pressure sensitive adhesive, and the lower adhesive layer may comprise a sllicone pressure sensitive adhesive. Alternatively, the wound contact layer 6004 cannot be provided with adhesive.
In some embodiments, the wound contact layer 6004 may be transparent or translucent. The film layer of the wound contact layer 6004 can define a perimeter with a rectangular shape or a square shape. A release layer 6002 can be detachably attached to the bottom of the wound contact layer 6004, for example by covering the bottom adhesive layer, and can be peeled using fins. Some embodiments of release layer 6002 may have a plurality of fins that extend along the length of layer 6002.
In alternative modalities, a transmission layer (not shown) can be included in the bandage. The transmission layer can be in multiple locations, such as: below the stabilization structure, between the stabilization structure and the wound contact layer, above the stabilization structure, between the stabilization structure and the acquisition distribution layer, or between any other component layers of the bandage. Some modes of the transmission layer may be formed of a material that has a three-dimensional structure. For example, a woven or spun spader fabric (such as Baltex 7970 weft spun polyester) or a non-woven fabric can be used. In some embodiments, the transmission layer may have a layer of 3D polyester spacer fabric. This layer may have an upper layer which is a 84/144 textured polyester, and a Lower layer which may be a 100 denier flat polyester and a third formed layer sandwiched between these two layers which is a region defined by a viscous spun polyester, cellulose or monofilament fiber type. In use, this differential between the count of filaments in the separated layers tends to draw fluid away from the wound bed and into a central gutter of the dressing 6000 where the absorbent layer 6010 helps to block the fluid away or absorbs it the liquid thereafter into cover layer 6014 where it can be transpired. Other materials may be used, and examples of such materials are described in US Patent Publication No. 2011/0282309, Incorporated by reference and is part of this description. However, the transmission layer is optional and more details regarding the transmission layer can be found in Appendix A.
Some modalities may comprise Acquisition or Absorption Distribution Layer (ADL) 6008 to horizontally absorb fluid such as wound exudate as it is absorbed upward through the layers of bandage 6000. Lateral fluid absorption may allow maximum fluid distribution through absorbent layer 6010 and can allow absorbent layer 6010 to reach its full holding capacity. This can advantageously increase moisture vapor penetration and efficient supply of negative pressure to the wound site. Some embodiments of ADL 6008 may comprise viscose, polyester, polypropylene, cellulose, or a combination of some or all of them, and the material may be needle punched. Some modalities of ADL 6008 may comprise polyethylene in the range of 40-150 grams per square meter (gsm). In some embodiments, the ADL 3440 may have a thickness of 1.2mm or approximately 1.2mm, or may have a thickness in the range of 0.5mm to 3.0mm, or approximately 0.5mm to approximately 3.0mm.
In certain embodiments, ADL 6008 or any suitable absorption layer can penetrate cells of the stabilization structure to absorb fluid from the wound. The cells can be partially or totally penetrated by the ADL 6008 or the suitable absorption layer depending on the density and / or compressibility of the ADL 6008 or suitable absorption layer. In some embodiments, the cells may contain both a superabsorbent and a suitable ADL 6008 or absorption layer.
As described above, bandage 6000 may comprise an absorbent or superabsorbent layer 6010. The absorbent layer may be made from foam
ALLEVYNTM, Freudenberg 114-224-4 and / or Chem-Posite ™ 11C-450, or any other suitable material. Alternatively, the layer may be formed from gauze. In some embodiments, the absorbent layer 6010 may be a layer of nonwoven cellulose fibers having superabsorbent material in the form of dry particles dispersed throughout. The use of cellulose fibers Introduces fast-absorbing elements that help quickly and uniformly distribute the liquid absorbed by the bandage. The juxtaposition of multiple strand-like fibers leads to strong capillary action on the fibrous pad that helps distribute fluid. In some embodiments, the absorbent layer 6010 may have a thickness of 1.7mm or about 1.7mm, or it may have a thickness in the range of 0.5mm to 3.0mm, or about 0.5mm to about 3.0mm.
For example, some embodiments of absorbent layer 6010 may comprise a layered construction of a top layer of nonwoven cellulose fibers, superabsorbent particles (SAP), and a bottom layer of cellulose fibers with 40 to 80% SAP. In some embodiments, the absorbent layer 6010 may be an air laid material. Heat fusible fibers can be used optionally to help keep the pad structure together. Some modalities may combine cellulose fibers and air laid materials, and may further comprise up to 60% SAP. Some modalities may comprise 60% SAP and 40% cellulose. Other modes of the absorbent layer may comprise between 60% and 90% (or between approximately 60% and approximately 90%) of the cellulose matrix and between 10% and 40% (or between approximately 10% and approximately 40%) of particles. superabsorbents. For example, the absorbent layer may have approximately 20% super absorbent material and approximately 80% cellulose fibers. It will be appreciated that instead of or in addition to using superabsorbent particles, superabsorbent fibers can be used in accordance with some embodiments of the present invention. An example of a suitable material is the Chem-PosIteTM 11C product available from Emerglng Technologies Inc (ET) in the USA.
The superabsorbent particles / fibers can be, for example, sodium pollacrylate or carbomethoxycellulose or the like materials or any material capable of absorbing many times its own weight in liquid. In some embodiments, the material can absorb more than five times its own weight of 0.9% W / W of saline, etc., more than 15 times its own weight, or more than 20 times its own weight. Preferably, the material is capable of absorbing more than 30 times its own weight of 0.9% W / W of saline, etc. The absorbent layer 6010 may have one or more through holes 6018 positioned to be the base of the suction port.
Some embodiments of the present disclosure may employ a masking or blackout layer 6012 to help reduce the unsightly appearance of a bandage 6000 during use due to absorption of exudate from the wound. Darkening layer 6012 can be a colored portion of the absorbent material, or it can be a separate layer that covers the absorbent material. Darkening layer 6012 can be one of a variety of colors such as blue, orange, yellow, green, or any suitable color to mask the presence of wound exudate in bandage 6000. For example, a blue darkening layer 6012. It can be a shade of blue similar to the shade of blue used for the material of medical gowns, disposable hospital clothing, and surgical drapes. Some embodiments of blackout layer 6012 may comprise polypropylene nonwoven. In addition, some embodiments of blackout layer 6012 may comprise a hydrophobic additive or coating. Other modalities may comprise a 60, 70, or 80 gsm thin fibrous sheet. In some embodiments, the darkening layer 6012 may be 0.045mm or about 0.045mm thick, or it may have a thickness in the range of 0.02mm to 0.5mm, or about 0.02mm to about 0.5mm.
Figure 36 depicts an exploded view of an embodiment of a bandage similar to the bandage embodiment of Figure 35, comprising a support layer 6110, a darkening layer 6120, an absorbent layer 6130, an ADL 6140, a structure stabilization 6150, and a wound contact layer 6160. Here, the 6100 dressing is square rather than rectangular. However, as described above, the bandage can take many forms, and many modalities of bandaging are described in more detail in Appendix A. In addition to the components described below, the modality illustrates the 6180 release layer, flap (s ) 6181, and through hole 6131.
Darkening layer 6120 may comprise at least one viewing window 6122 configured to allow a visual determination of the saturation level of the absorbent layer. The at least one viewing window 6122 may comprise at least one opening made through the blackout layer. The at least one viewing window 6122 may comprise at least one colorless region of the darkening layer. Some modes of the blackout layer may comprise a plurality of display windows or an array of display windows.
The masking capabilities of the darkening layer 6120 should preferably be only partial, to allow clinicians to access the information they need by observing the spread of exudate across the bandage surface. The nature of the partial masking of the 6120 darkening layer allows a skilled practitioner to perceive a different color caused by exudate, blood, by-products, etc., in the dressing allowing visual evaluation and monitoring of the extent of spread through the bandage. However, since the change in the color of the bandage from its clean state to a state with the exudate content is only a slight change, the patient is unlikely to notice any aesthetic difference. The reduction or elimination of a visual indicator of exudate from a patient's wound is likely to have a positive effect on their health, stress reduction, for example.
Darkening layer 6120 may have one or more through holes positioned such that it is the base of the suction port. Some modalities may have a 6121 malt cross or other formed cut underlying the suction port, where the diameter of the 6121 malt cross is greater than the diameter of the port. This can allow a doctor to easily assess the amount of wound exudate absorbed in the layers below the port. The darkening layer 6120 may have an outer perimeter that is greater than the dressing layer or layers provided thereunder, for example the absorbent layer 6130, ADL 6140 and / or the stabilizing structure 6150. In some embodiments, the outer perimeter The entire darkening layer 6120 is spaced 1mm, or approximately 1mm, or 0.5mm to 3mm, or approximately 0.5 to approximately 3mm, beyond the bandage layer or layers provided below them. The larger perimeter of the darkening layer 6120 can ensure that the underlying layers are adequately covered by visual darkening of the wound exudate. Additional details and experiments related to the darkening layer can be found in Appendix A.
Bandage 6100 may also comprise a support layer, or cover layer 6110 that extends across the width of the wound dressing. Cover layer 6110 may be gas impervious but permeable to wet vapor. Some embodiments may employ a polyurethane film (eg Elastollan SP9109) or any other suitable material. For example, certain embodiments may comprise translucent or transparent 30 gsm EU33 film. Cover layer 6110 may have a pressure sensitive adhesive on the underside, thereby creating a substantially sealed enclosure over the wound in which negative pressure can be established. The cover layer can protect the wound as a bacterial barrier from external contamination, and can allow fluid from wound exudates to be transferred through the layer and evaporated from the outer surface of the film.
Cover layer 6110 may have a hole 6111 located in order to be the base of the suction port. Orifice 6111 may allow transmission of negative pressure through cover layer 6110 into the wound enclosure. The port can be adhered and sealed to the cover film by an adhesive such as an acrylic, cyanoacrylate, epoxy, UV-curable or hot melt adhesive. Some embodiments may have a plurality of ports for joining multiple ports or other sources of negative pressure or other mechanisms for fluid distribution.
With respect to the relative thicknesses of the bandage layers 6100, in some embodiments the wound contact layer 6160 may be flat and the top film layer
6110 It can be contoured over the Inner layers of the 6100 bandage. The 6150 stabilization structure can be half the thickness of the ADL 6140 in some modalities. In additional embodiments, the stabilization structure 6150 can be as thick or thicker than the ADL 6140 layer. For example, the stabilization structure can be at least about 1.5 times thicker, 2 times as thick, 3 times thicker, 5 times thicker, or 10 times thicker or more. In some embodiments, the absorbent layer 6130 can be approximately 1.5 times thicker than the stabilization structure 6150. The darkening layer 6120 can be approximately half the thickness of the spacer layer 6150.
In some embodiments, the length or width of the stabilizing structure 6150 may be greater than the thickness. For example, the stabilizing structure 6150 may have a thickness that is at most approximately: 10% of the length or width, 20% of the length or width, 30% of the length or width, 40% of the length or width, 50% of the length or width, or more than 50%. In some embodiments, the relative dimensions of the stabilization structure 6150 may be the same as the relative dimensions of the stabilization structure modalities described elsewhere in the specification.
Figure 37 depicts an embodiment of the 6200 system for treating an incised wound 6202 comprising a wound contact layer 6204 such as those described herein in this section or elsewhere in the specification, a stabilization structure 6206 such such as those described here in this section or elsewhere in the specification, and a curtain 6208 such as those described here in this section or elsewhere in the specification. This system may further comprise a negative pressure source (not shown) in fluid communication with the wound. As described elsewhere in the specification, tissue anchors such as those described in relation to Figures 34A to 34B or adhesives can be used to adhere stabilizing structure 6206 to the skin surrounding the incised wound 6202.
In some embodiments, the gauze (not shown) can be placed under stabilization structure 6206 to prevent the formation of granulation tissue. Also, the gauze can be replaced by the foam and / or absorbent layers described here in this section or elsewhere in the specification. In some contexts, gauze can advantageously reduce granulation tissue formation when used in combination with stabilization structures such as those described herein in this section or elsewhere in the specification, particularly in relation to Figures 1 to 3B and Figures 35 to 37.
FIG. 38 depicts an embodiment of a bandage 7000, similar to embodiment 6000 depicted in FIG. 35 and described elsewhere in the specification. As in the bandage of Figure 35, the stabilization structure 6006 may be under the absorbent layer 6010 and below an optional acquisition distribution layer 6008, the absorbent layer optionally comprising superabsorbent material. Bandage 7000 may or may not have a masking layer, potentially allowing direct visualization of and through the absorbent layer. The absorbent layer 6010 may comprise multiple through holes 6020 that pass through the layer. Additional examples of through holes can be found in US Application No. 62/013989, filed June 18, 2014, entitled WOUND DRESSING AND METHOD OF TREATMENT, and US Application No. 62/085774, filed on December 1, 2014 entitled WOUND DRESSING AND METHOD OF TREATMENT. The aforementioned requests are incorporated by reference herein in their entirety.
In some embodiments, some or all of the through holes 6020 may comprise (i.e. be clogged or filled by) a plug material, eg, a soft, transparent, and optionally hydrophobic material (eg, silicone). The plug material is preferably made of a stiffer material than that of the absorbent layer. The plug material can provide the benefit of preventing lateral inflammation of superabsorbent particles in the absorbent layer 6010, which can cause the particles to spill out of the absorbent layer material 6010 at the cutting edges, thus filling (at least partially) through holes 6020. The transparency of the plug material provides visibility through the wound bed. As a result of the hydrophobic nature of some modalities of the cap material, the through holes 6020 will remain transparent at all times of use as colored wound exudate and other substances do not need to be drawn into the cap material as it is hydrophobic. . In embodiments comprising a blackout layer with viewing windows (not shown in Figure 38, but described elsewhere in the specification), the viewing windows may be aligned with the through holes through the absorbent layer to allow for the visualization through the bandage. As a further example, the through holes can be aligned with the cells of the stabilization structure 6006, allowing visualization all the way down into the wound, whether the ADL is transparent or not included. In certain embodiments, the ADL may comprise through holes that align with the through holes in the absorbent layer. However, such alignment may not be necessary as the stabilization structures described here in this section and elsewhere in the specification do not display it substantially dark in the vertical direction. In certain embodiments the cells of the stabilization structure may optionally also be filled or partially filled with the plug material.
As described above, some examples of plug material are non-absorbent, so they do not fill with exudate. In certain embodiments, larger through holes can be provided in bandage modalities that utilize the plug material as compared to bandage modalities without the cap material. In some embodiments, when the plugs are provided in through holes 6020 of the absorbent layer 6010 and optionally in the cells of the stabilization structure 6006, the cells of the stabilization structure 6006 may be of the same shape and dimension as the through holes. 6020 or vice versa. In other embodiments, when the plugs are provided in through holes 6020 of the absorbent layer 6010, no stabilizing structure 6006 is provided.
The through holes 6020 in the absorbent layer 6010 can form a repeating pattern across the area of the absorbent layer 6010 with the exception of the area of the absorbent layer 6010 including the larger through hole 6018 for port 6016. The repeating pattern It may be in the form of a grid or through hole arrangement 6020, although other patterns may be used. In some embodiments, through holes 6020 in absorbent layer 6010 may be 10 mm (or approximately 10 mm) or less apart. In certain embodiments, the through holes can be separated by at least about 0.5mm, 1mm, 2mm, 4mm, 5mm, 10mm, 15mm, 20mm, 30mm, 40mm, 50mm, 75mm, or more than 75 mm. In modalities, the diameter of the through holes can be at most about .05mm, 0.1mm, 0.2mm, 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 10mm, 15mm, 20mm, 30 mm or more than 30 mm. In embodiments, the through hole 6018 underlying port 6016 may be separated from the through hole repeating pattern 6020 in the absorbent layer and larger than through holes 6020, however, in some embodiments, the through hole repeating pattern 6020 it can continue through the entire area (or substantially the entire area) of the absorbent layer 6010 and the port can be placed over a selected one of the through holes in the array, or more than a selected group of adjacent through holes in the array.
Through holes 6020 can be cut or formed in some ways by punching, die-cutting, laser cutting or cutting of the sheet materials used to form absorbent layer 6010. However, the creation of openings, for example by drilling holes, has the disadvantages of resulting in the generation of waste and also the mechanical weakening of the material. By forming through grooves in a material, these grooves are capable of expanding to form openings in the extent of the material, increased visibility of the wound can be achieved without wasting significant material. In this way, it is also possible to achieve the extension of the groove to form a circular hole without mechanically weakening the material. Examples of such net cutting techniques are described in International Patent Publication No. PCT / US2007 / 079529, filed on September 26, 2007, titled NETWORK BANDAGE, all of which is incorporated herein by reference. In some embodiments, separate portions of plug material can be provided to the through holes in multiple layers (in this case, the absorbent layer 6010), for example as the holes are drilled or cut in the layer. In some embodiments, the layers can be stacked and hole punched or cut together and consequently a single portion of plug material can be provided by spreading through the multi-layer holes. In certain embodiments, as described above, the through holes in the absorbent layer can be filled with a plug material. The plug material may be stiffer than the surrounding absorbent material ( eg, silicone material), thereby creating pillars of the plug material within the absorbent layer. Due to the hydrophobicity and stiffness of the abutments, and under negative pressure the abutments can maintain their vertical stiffness while the absorbent layer compresses horizontally. Therefore, the absorbent layer will demonstrate anlsotropic fold, similar to the anlsotropic fold experienced by the stabilization structures described throughout the specification. During folding, the absorbent layer will compress horlzontally while maintaining vertical rigidity, thus causing the abutments to be pulled closer to each other. In certain embodiments, the absorbent layer may be constructed of a less dense nonwoven material, thereby allowing for greater crease in the absorbent layer. In other embodiments, the absorbent layer may be constructed from denser materials, reducing the amount of horizontal compression.
FIG. 39 depicts a top view of one embodiment of a wound dressing 7000 configured for visibility of improved tissue, similar to the wound dressing embodiment of FIG. 38. The wound dressing 7000 may be located at a wound site. or wound formation tissue site to be treated as described above. In some embodiments, the bandage 7000 comprises a cover layer attached to a tissue contact layer, for example any of the cover layer or tissue contact layer modalities described elsewhere in the specification. These two layers can be joined or sealed together around a perimeter 6022 in a way that defines an Interior space or chamber in which there can be a therapeutic negative pressure. This Interior space or chamber may Include absorbent layer 6010, which may be any of the absorbent materials described here in this section or elsewhere in the specification. A port 6016 and conduit 6026 can be attached to bandage 7000.
As described elsewhere in the specification, the absorbent layer 6010 may include a number of through holes 6020 arranged in a repeating pattern. Through Holes provide 6024 viscoal portals through the Inner Layers of the 7000 bandage. In some embodiments, the optional ADL (6008 in Figure 38) may not be Included, be transparent, or contain aligned through holes. In such modalities, since the stabilization structure (not shown in Figure 39) comprises a matrix with open vertical pathways, the viewing portals can provide a clear view through the bandage. As described above, some or all of the through holes in the absorbent layer may comprise a transparent plug material. Therefore, due to the transparency or translucency of the cover layer and tissue contact layer, in the modalities the viewing portals 6024 may allow visualization of the tissue under the wound dressing through the wound cover when the wound dressing is applied to a patient, for example by allowing a physician to assess the characteristics of and changes in the underlying tissue of the 7000 dressing.
The features, materials, characteristics or groups described in conjunction with a certain aspect, modality or example must be understood to be applicable to any other aspect, modality or example described in this section or in another part of this specification unless they are incompatible with the same. All the features described in this specification (including any of the accompanying claims, abstract and drawings), and / or all the steps of any method or procedure thus described, can be combined in any combination, except combinations where at least some of said features and / or steps are mutually exclusive. Protection is not limited to the details of any of the above modalities. Protection extends to any novel, or any new combination, of the features described in this specification (including any of the accompanying claims, abstract and drawings), or to any novel, or any novel combination, of the steps of any method or procedure thus described.
Although certain modalities have been described, these modalities have been presented by way of example only, and are not intended to limit the scope of protection. In fact, the novel methods and systems described in this section or elsewhere in this specification can be performed in a variety of other ways. Furthermore, various omissions, substitutions, and changes in the form of the methods and systems described in this section or elsewhere in this specification can be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the illustrated and / or described procedures may differ from those shown in the figures. Depending on the modality, some of the steps described above can be removed, others can be added. Furthermore, the characteristics and attributes of the specific modalities described above can be combined in different ways to form additional modalities, all of which fall within the scope of the present description.
Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those of skill in the art that the present disclosure extends beyond the embodiments specifically described to other alternative embodiments and / or obvious uses and modifications and their equivalents, Including modalities that do not provide all the features and benefits discussed in this section or elsewhere in this specification. Accordingly, the scope of the present disclosure is not intended to be limited by the specific descriptions of preferred embodiments in this section or elsewhere in this specification, and may be defined by the claims as presented in this section or elsewhere. part in this specification or as presented in the future.
Contents7
96 sheets
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23 members in 9 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 61929870 | United States of America | – | |
| 201461929870 | United States of America | P | |
| 2015050963 | European Patent Office (EPO) | W |
Members23
| Document | Office | Kind | |
|---|---|---|---|
| CA2937399A1 | Canada | A1 | |
| WO2015110410A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2015208299A1 | Australia | A1 | |
| MX2016009477AThis record | Mexico | A | |
| MX2016009477AThis record | Mexico | A | |
| EP3096728A1 | European Patent Office (EPO) | A1 | |
| CN106255481A | China | A | |
| US2017007751A1 | United States of America | A1 | |
| JP2017508501A | Japan | A | |
| RU2016133735A | Russian Federation | A | |
| RU2016133735A | Russian Federation | A | |
| US10201642B2 | United States of America | B2 | |
| US2019240385A1 | United States of America | A1 | |
| AU2015208299B2 | Australia | B2 | |
| CN106255481B | China | B | |
| CN110974539A | China | A | |
| JP6742908B2 | Japan | B2 | |
| EP3096728B1 | European Patent Office (EPO) | B1 | |
| US11344665B2 | United States of America | B2 | |
| EP4008299A1 | European Patent Office (EPO) | A1 | |
| US2022313893A1 | United States of America | A1 | |
| CA2937399C | Canada | C | |
| EP4008299B1 | European Patent Office (EPO) | B1 |
Numbers
- Publication
- 2016009477
- Application
- 9477
Titles2
- Spanish
- VENDAJE PLEGABLE PARA EL TRATAMIENTO DE HERIDAS CON PRESION NEGATIVA.
- English
- COLLAPSIBLE DRESSING FOR NEGATIVE PRESSURE WOUND TREATMENT.
Classification
- CPC, 10
- A61F13/0206
- A61M1/90
- A61F13/00059
- A61F13/0209
- A61F13/022
- A61F13/0223
- A61F2013/00182
- B32B3/12
- A61M1/91
- A61F13/05
- IPC, 2
- A61F13 02
- A61F13 00