Patent Application
20190183685
Clinical studies and practice have shown that providing a negative pressure in proximity to a tissue site promotes the growth of new tissues at the tissue site. The application of negative pressure is successful in treating wounds. This treatment (frequently referred to in the medical community as “negative pressure wound therapy (NPWT),” “reduced pressure therapy,” or “vacuum therapy”) provides a number of benefits, including faster healing and increased formulation of granulation tissue. Typically, reduced pressure is applied to tissues through a foam, a pad or other manifolding device, such as gauze. The manifolding device typically contains cells, pores or other openings that are capable of distributing reduced pressure to the tissue and channeling fluids that are drawn from the tissue. The porous pad often is incorporated into a dressing having other components that facilitate treatment.
Other know NPWT articles are discussed in U.S. Pat. Nos. 7,494,482; 8,057,447; 8,889,243 and 9,107,989.
In one aspect, the present disclosure provides an article, including a network of interconnected polymeric strands; wherein each of the interconnected polymeric strands has a first surface adapted to contact a tissue site; wherein at least one of the interconnected polymeric strand has a plurality of features extending from the first surface of the interconnected polymeric strands; wherein at least one of the interconnected polymeric strands is non-linear; and a plurality of openings between adjacent polymeric strands; wherein the article is a negative pressure wound therapy article.
In another aspect, the present disclosure provides a system, including the article of present disclosure and a reduced pressure source fluidly connected to the opening of the article to deliver the reduced pressure through the opening, between the features, and to the tissue site.
In another aspect, the present disclosure provides a method, including providing the article of present disclosure and positioning the article on a wound.
Various aspects and advantages of exemplary embodiments of the present disclosure have been summarized. The above Summary is not intended to describe each illustrated embodiment or every implementation of the present disclosure. Further features and advantages are disclosed in the embodiments that follow. The Drawings and the Detailed Description that follow more particularly exemplify certain embodiments using the principles disclosed herein.
The disclosure may be more completely understood in consideration of the following detailed description of various embodiments of the disclosure in connection with the accompanying figures, in which:
While the above-identified drawings, which may not be drawn to scale, set forth various embodiments of the present disclosure, other embodiments are also contemplated, as noted in the Detailed Description. In all cases, this disclosure describes the presently disclosed invention by way of representation of exemplary embodiments and not by express limitations. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of this disclosure.
Before any embodiments of the present disclosure are explained in detail, it is understood that the invention is not limited in its application to the details of use, construction, and the arrangement of components set forth in the following description. The invention is capable of other embodiments and of being practiced or of being carried out in various ways that will become apparent to a person of ordinary skill in the art upon reading the present disclosure. Also, it is understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. It is understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure.
As used in this Specification, the recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.8, 4, and 5, and the like).
Unless otherwise indicated, all numbers expressing quantities or ingredients, measurement of properties and so forth used in the Specification and embodiments are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached listing of embodiments can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings of the present disclosure. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claimed embodiments, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
The article of the present application is well suited to promote tissue growth at the tissue site yet prevent in-growth of new tissue into the article. The article of the present application can help to deliver a significant portion of microstrain to the wound site by the architecture of the article, for example, the surface morphology of the article and thus may allow for lower pressure settings for NPWT to be used (for example, −75 mmHg vs −125 mmHg). This may allow a longer battery life of the NPWT system and the use of smaller pumps for the NPWT.
Referring to
Referring more specifically to
In some embodiments, the article comprising interconnected polymeric strands has a thickness up to 2 mm, up to 1 mm, up to 500 micrometers, up to 250 micrometers, up to 100 micrometers, up to 75 micrometers, up to 50 micrometers, or up to 25 micrometers. In some embodiments, the article comprising interconnected polymeric strands has a thickness no less than 10 micrometers. In some embodiments, the article comprising interconnected polymeric strands has a thickness in a range from 10 micrometers to 2 mm, 10 micrometers to 1 mm, 10 micrometers to 750 micrometers, 10 micrometers to 500 micrometers, 10 micrometers to 250 micrometers, 10 micrometers to 100 micrometers, 10 micrometers to 75 micrometers, 10 micrometers to 50 micrometers, or 10 micrometers to 25 micrometers. In some embodiments, the article comprising interconnected polymeric strands has an average thickness in a range from 250 micrometers to 5 mm.
In some embodiments, at least one of the interconnected polymeric strands 12 may be non-linear. In some embodiments, at least 25% of the interconnected polymeric strands 12 may be non-linear. In some embodiments, at least 50% of the interconnected polymeric strands 12 may be non-linear. In some embodiments, at least 75% of the interconnected polymeric strands 12 may be non-linear. In some embodiments, essentially all the interconnected polymeric strands 12 may be non-linear. In some embodiments, all of the interconnected polymeric strands 12 may be non-linear. In some embodiments, the non-linear polymeric strand may have a shape of a curve. In some embodiments, the non-linear polymeric strand may have a shape of a sinusoidal curve. In some embodiments, the non-linear polymeric strand may have a shape of a sinusoidal curve. In other embodiments, at least one of the interconnected polymeric strands 12 may be linear. In some other embodiments, 25% to 75% of the interconnected polymeric strands 12 may be linear. In some other embodiments, 50% to 75% of the interconnected polymeric strands 12 may be linear. In certain embodiments, the network of interconnected polymeric strands may include alternating non-linear polymeric strands and linear polymeric strands, as shown in
In some embodiments, aspect ratio (a ratio of the length to the width) of the openings 14 may be greater than 1:1, 1.5:1, 2:1, 3:1 or 5:1. In some embodiments, aspect ratio (a ratio of the length to the width) of the openings 14 may be in a range from 1:1 to 100:1, 1:1 to 75:1, 1:1 to 50:1, 1:1 to 25:1, 2:1 to 100:1 2:1 to 75:1, 2:1 to 50:1, 2:1 to 25:1, or 2:1 to 10:1. The length, L1, of an opening 14 illustrated in
In some embodiments, openings 14 may have any suitable shape, for example, a shape selected from shapes of ellipse, oval, pointed oval (or lens), diamond, ½ ellipse, ½ oval, ½ lens, triangle, etc. In some embodiments, the openings of the mechanical fastening nets described herein have at least two pointed ends. In some embodiments, at least some of the openings are elongated with two pointed ends. In some embodiments, at least some of the openings are elongated with two opposed pointed ends. In some embodiments, at least some of the openings are ovals.
In some embodiments, the article described herein have a total open area for each of the first and second, generally opposed surfaces of not greater than 50 (in some embodiments, not greater than 45, 40, 35, 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.75, 0.5, 0.25, or even not greater than 0.1) percent of the total area of the respective surface. In some embodiments, for at least a majority of the openings of the article described herein, the maximum area of each opening is not greater than is 5 (in some embodiments, not greater than 2.5, 2, 1, 0.5, 0.1, 0.05, 0.01, 0.075, or even not greater than 0.005)mm2. Individual openings range from 0.005 mm2 to 5 m2. In some embodiments, the article according to the present disclosure have in a range from 50,000 to 6,000,000 (in some embodiments, 100,000 to 6,000,000, 500,000 to, 6,000,000, or even 1,000,000 to 6,000,000) openings/m2.
In some embodiments, the tensile strength of the article parallel to x direction is greater than the tensile strength of the article parallel to y direction. Therefore, the article is easier to be stretched in y direction than in x direction. In some embodiments, the tensile strength of the article parallel to x direction is at least 2.23 Mpa, at least 2.25 Mpa, at least 2.5 Mpa or at least 3.0 Mpa. In some embodiments, the tensile strength of the article parallel to x direction is up to 5.42 MPa, up to 5.3 MPa, up to 5.0 MPa, or up to 4.5 MPa. In some embodiments, the tensile strength of the article parallel to x direction is from 2.23 Mpa to 5.42 MPa., from 2.5 Mpa to 5.0 MPa or from 3.0 Mpa to 4.5 MPa. The Young's modulus of the article is up to 10.6 MPa, up to 10.0 MPa, up to 9.0 MPa, or up to 8.0 MPa. The Young's modulus of the article is at least 3.85 MPa, at least 4.0 MPa has a range from 3.85 MPa to 10.6 MPa in a direction parallel to x direction.
The shape, sizing, and spacing of the features 18 may vary depending upon the particular tissue site being treated, the type of material from which the features 18 and polymeric strands are made, and the amount of reduced pressure being applied to the tissue site. For example, for tissue sites that are highly exudating, it may be advantageous to position the protrusions farther apart or reduce the density of features on the first surface to maintain adequate distribution channels between the features 18. In one embodiment of the present invention, the shape, sizing and spacing of the features 18 is uniform for a particular article 10. In other embodiments, the shape, sizing, and spacing of the features 18 may be different. For example, features 18 having different cross-sectional shapes may be disposed on the first surface. Similarly, the sizing and spacing of the features 18 may vary to supply selected portions of the tissue site with different (more or less) reduced pressure and different flow rate for exudates withdrawn.
Referring more specifically to
In some embodiments, features 18 are oriented along the interconnected polymeric strands 12 as illustrated in
The presence and sizing of the features 18 allow the features 18 to distribute reduced pressure to the tissue site, but prevent new tissue that grows at the tissue site from attaching to the features 18 or growing into the spacing between features 18. While new tissue growth may wrap around some of the features 18, the new tissue is not capable of securing itself to the features 18 since the base of each features is anchored to the first surface 16.
In addition to distributing reduced pressure to the tissue site, the article 10 also serves to impart stresses and strains to the tissue site similar to those seen with cellular foam that traditionally has been used in reduced pressure systems. Other materials sometimes used in reduced pressure systems, such as gauze, do not have this effect on tissue. Unbound by the theory, the stresses and strains created by the article 10 are believed to cause micro-deformation of existing tissues and plays a significant role in the generation of new tissues at the tissue site. The amount of stress and strain imparted to a tissue site is determined by the amount of reduced pressure supplied to the tissue site and the surface morphology of the article that contacts the tissue site. As reduced pressure is applied, portions of the tissue site are pulled against the article 10, and more particularly against the features 18, which results in the development of stresses and strains within the tissue. In some embodiments, the article of the present disclosure can be a mechanical fastening net or a mechanical fastening sheet with features.
Referring to
The article 10 may further include a cellular foam or another material that is positioned adjacent to or attached to the surface of the interconnected polymeric strands opposite the features 18. The use of a cellular foam or other material increases the ability of the reduced pressure conduit 29 or the distribution adapter 35 to deliver and distribute reduced pressure to the article 10. The features 18 and interconnected polymeric strands serve as a barrier to new tissue growth entering pores of the cellular foam or other material.
In some embodiments, the interconnected polymeric strands 12 can include an elastomeric polymer. Elastomeric polymer can be any suitable elastomeric polymer, including but not limited to polyolefins and polyurethanes. In some embodiments, elastomeric polymer can be a medical grade material that is relatively impermeable to fluid flow. Alternatively, elastomeric polymer can be a semi-permeable material that allows select fluids or amounts of fluids to pass. In some embodiments, the interconnected polymeric strands 12 are formed from the same material as the features 18. In some embodiments, the interconnected polymeric strands 12 can be formed from a different material as the features 18. In some embodiments, the composition of interconnected polymeric strands 12 may be formed from different materials.
Some embodiments of the present wound-treatment methods can include positioning the article of present disclosure on a wound of a patient and applying a reduced pressure to the wound through the article (e.g., through the openings). Some embodiments further comprise: coupling a drape to skin adjacent the wound such that the drape covers the article and the wound, and forms a space between the drape and the wound. In some embodiments, positioning the article on the wound can include placing the article over the wound with the features on the first surface facing the wound. In some embodiments, applying the reduced pressure to the wound comprises activating a vacuum source (e.g., reduced pressure source 23 of
The following embodiments are intended to be illustrative of the present disclosure and not limiting.
a network of interconnected polymeric strands; wherein each of the interconnected polymeric strands has a first surface adapted to contact a tissue site; wherein at least one of the interconnected polymeric strand has a plurality of features extending from the first surface of the interconnected polymeric strands; wherein at least one of the interconnected polymeric strands is non-linear; and
a plurality of openings between adjacent interconnected polymeric strands;
wherein the article is a negative pressure wound therapy article.
the article of any one of embodiments 1 to 14; and
a reduced pressure source fluidly connected to the opening of the article to deliver the reduced pressure through the opening, between the features, and to the tissue site.
providing the article of any one of embodiments 1 to 14; and
positioning the article on a wound.
The following working examples are intended to be illustrative of the present disclosure and not limiting.
A polyolefin net was prepared using ENGAGE 8200 polyolefin elastomer (obtained from the Dow Chemical Company, Midland, Mich.) according to the methods described in United States Patent Application 2014/0234606 (Ausen), herein incorporated by reference in its entirety. The resulting net material had strand width ranges of about 0.42-0.83 mm, pore width ranges of about 0.15-0.57 mm, pore length ranges of about 1.5-2.1 mm, and a thickness range of about 0.75-1.24 mm. The net sample was embossed by stacking from top to bottom a steel plate, a square pattern polypropylene film that served as the mold (inner dimension of a square being approximately 0.5 mm), the polyolefin net sample, a release liner, and a second steel plate. The stack was placed in a Carver Auto Series NE Automatic Hydraulic Press (Model 3895.4NE1000, Carver Inc., Wabasha, Ind.) with the bottom platen of the press set at 21° C. and the top platen set at 121° C. The press was closed and the sample was held at a set force of 794 kg for two minutes, followed by a cool down period of four minutes to 65.5° C. The press was opened and the embossed sample was removed from the press. The resulting embossed article had a base thickness range of about 0.56-0.65 mm; strand width ranges of about 0.45-0.50 mm; openings with width ranges of about 0.13-0.37 mm and length ranges of about 0.87-1.10 mm; features with width at base of about 0.5 mm and height ranges of about 0.29-0.50 mm; and feature spacing ranges of about 0.77-0.94 mm.
A polyurethane net was prepared using IROGRAN A 60 E 4902 thermoplastic polyurethane (obtained from the Huntsman Corporation, The Woodlands, Tex.) according to the methods described in United States Patent Application 2014/0234606 (Ausen). The resulting net material had strand width ranges of about 0.29-0.46 mm, pore width ranges of about 0.20-0.37 mm, pore length ranges of about 1.8-3.0 mm, and a thickness range of about 0.66-0.73 mm. The net sample was embossed by stacking from top to bottom a steel plate, a square pattern polypropylene film that served as the mold (inner dimension of a square being approximately 0.5 mm), the polyolefin net sample, a release liner, and a second steel plate. The stack was placed in a Carver Auto Series NE Automatic Hydraulic Press (Model 3895.4NE1000, Carver Inc.) with the bottom platen of the press set at 176.6° C. and the top platen set at 21° C. The stack was warmed on the apparatus for two minutes. The press was then closed and the sample was held at a set force of 907 kg for two minutes, followed by a cool down period of five minutes to 93.3° C. The press was opened and the embossed sample was removed from the press. The resulting embossed article had a base thickness range of about 0.36-0.49 mm; strand width ranges of about 0.33-1.10 mm; openings with width ranges of about 0.25-0.58 mm and lengths of about 2.20 mm; features with width at base of about 0.5 mm and height ranges of about 0.27-0.42 mm; and feature spacing ranges of about 0.73-0.88 mm. A scanning electron microscope image of the article is shown in
The cell culture device having a lower base unit, a seal, an upper base unit, a cell culture insert for growing cell cultures, a sealing member, a guide tube, a support bracket, a vacuum conduit, a media conduit, a second seal and screw, was used. Fibroblasts were encapsulated in a fibrin gel matrix (clot) to simulate a component of the wound healing environment. The matrix was prepared by the following three step procedure. First, a layer of fibrin gel was prepared and applied to the internal surface of the permeable membrane (24 mm diameter with 1 micron pore size) in a MILLICELL hanging cell culture insert (obtained from EMD Millipore, Billerica, Mass.) by combining 1 mL of human fibrinogen (concentration of 9.8 mg per mL of porcine plasma) with 0.25 mL of thrombin (concentration of 500-1100 units per mL of porcine plasma) (human fibrinogen obtained from Sigma-Aldrich Corporation, St. Louis, Mo.; thrombin obtained from BioPharm Laboratories, Bluffdale, Utah; porcine plasma obtained from Lampire Biological Lab, Piphersville, Pa.). This layer was covered with a layer of about 50,000 fibroblasts (obtained from Invitrogen Corporation, Carlsbad, Calif.). The fibroblast layer was then covered with a third (or top layer) of fibrin gel prepared in the same manner as for the first layer. Following encapsulation in the gel, the fibroblasts were grown in an incubator at 37° C. for two days.
In the cell proliferation assay, the article of Example 1 was placed over the top layer of the matrix with the surface of the article containing the feature elements facing and in contact with the gel matrix. The opposite face of the article was covered with an 10 mm thick pad of GRANUFOAM polyurethane foam (V.A.C. Granufoam Dressing Medium, KCI Inc., San Antonio, Tex.). The combined article of Example 1 and GRANUFOAM cover pad formed the test dressing. Fibroblast Culture Medium 106 (obtained from Invitrogen Corporation) was continuously supplied to the gel matrix by means of a peristaltic pump. Negative pressure (−125 mm Hg) was applied to the device for 48 hours at 37° C. The device was then dismantled and the fibroblast sample was evaluated for cell proliferation using an XTT colorimetric assay kit (obtained from Invitrogen Corporation) with the absorbance measurements taken at 570 nm using a SpectraMax M5 plate reader (Molecular Devices, Sunnyvale, Calif.). The level of fibroblast cell proliferation for the example was compared to a control experiment. In the control experiment, the same procedure was used except no test dressing was added to the apparatus and negative pressure was not applied for the 48 hour test period. In Table 1, the mean percent increase in recorded absorbance for the example compared to the control is reported (3 replicates).
The same procedure as described as in Example 3 with the exception that a 10 mm thick multilayer sheet of gauze (non-stick gauze pads were obtained from Johnson and Johnson Company, New Brunswick, N.J.) was used as the test dressing. In Tables 1 and 2, the mean percent increase in recorded absorbance for Comparative Example A compared to the control is reported (3 replicates with Tables 1 and 2 being separate experiments).
The same procedure as described as in Example 3 was used with the exception that the article of Example 2 was combined with a GRANUFOAM pad to form the test dressing. The mean percent increase in recorded absorbance for Example 4 is reported (3 replicates) in Table 2.
The same procedure as described as in Example 3 was used with the exception that the non-embossed net used to prepare the article of Example 2 (instead of the embossed article) was combined with a GRANUFOAM pad to form the test dressing. The mean percent increase in recorded absorbance for Comparative Example B compared to the control is reported (3 replicates) in Table 2.
The polyolefin net described in Example 1 sample was embossed by stacking from top to bottom a steel plate, a square pattern polypropylene film that served as the mold (inner dimension of a square being approximately 0.5 mm), the polyolefin net sample, a release liner, and a second steel plate. The stack was placed in a Carver Auto Series NE Automatic Hydraulic Press (Model 3895.4NE1000, Carver Inc.) with the bottom platen of the press set at 21° C. and the top platen set at 107° C. The press was closed and the sample was held at a set force of 794 kg for two minutes, followed by a cool down period of two minutes to 65.5° C. The press was opened and the embossed sample was removed from the press. The resulting embossed article had a base thickness range of about 0.36-0.99 mm; strand width ranges of about 0.27-1.3 mm; openings with width ranges of about 0.10-1.10 mm and length ranges of about 2.50-2.70 mm; features with width at base of about 0.5 mm and height ranges of about 0.19-0.22 mm; and feature spacing ranges of about 0.70-0.77 mm.
The polyurethane net described in Example 2 was embossed by stacking from top to bottom a steel plate, a square pattern polypropylene film that served as the mold (inner dimension of a square being approximately 0.5 mm), the polyolefin net sample, a release liner, and a second steel plate. The stack was placed in a Carver Auto Series NE Automatic Hydraulic Press (Model 3895.4NE1000, Carver Inc.) with the bottom platen of the press set at 176.6° C. and the top platen set at 21° C. The stack was warmed on the apparatus for two minutes. The press was then closed and the sample was held at a set force of 907 kg for four minutes, followed by a cool down period of three minutes to 93.3° C. The press was opened and the embossed sample was removed from the press. The resulting embossed article had a base thickness range of about 0.41-0.52 mm; strand width ranges of about 0.37-0.96 mm; openings with width ranges of about 0.13-0.46 mm and length ranges of about 0.92-1.60 mm; features with width at base of about 0.5 mm and height ranges of about 0.21-0.40 mm; and feature spacing ranges of about 0.77-0.86 mm.
The mechanical properties of the embossed articles of Example 5 and Example 6 were determined by testing individual embossed article samples with an INSTRON Model 5943 Mechanical Testing Apparatus (INSTRON Corporation, Norwood, Mass.). The tests were conducted at ambient conditions using a 100 N load cell. Samples were held with pneumatic grips. The rate of grip separation was 50 mm/minute. Measurements of samples in the direction of the interconnected strands (x-direction of
All references and publications cited herein are expressly incorporated herein by reference in their entirety into this disclosure. Illustrative embodiments of this invention are discussed and reference has been made to possible variations within the scope of this invention. For example, features depicted in connection with one illustrative embodiment may be used in connection with other embodiments of the invention. These and other variations and modifications in the invention will be apparent to those skilled in the art without departing from the scope of the invention, and it should be understood that this invention is not limited to the illustrative embodiments set forth herein. Accordingly, the invention is to be limited only by the claims provided below and equivalents thereof.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/038939 | 6/23/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62354894 | Jun 2016 | US |
