CA2183993A1 - Scar treatment sheeting and method of manufacture - Google Patents
Scar treatment sheeting and method of manufactureInfo
- Publication number
- CA2183993A1 CA2183993A1 CA002183993A CA2183993A CA2183993A1 CA 2183993 A1 CA2183993 A1 CA 2183993A1 CA 002183993 A CA002183993 A CA 002183993A CA 2183993 A CA2183993 A CA 2183993A CA 2183993 A1 CA2183993 A1 CA 2183993A1
- Authority
- CA
- Canada
- Prior art keywords
- article
- layer
- shapes
- polydimethylsiloxane
- polymer network
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/225—Mixtures of macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
Abstract
Elastomeric sheeting materials are described which are formed from the process of creating a membrane comprising polymer network ("IPN") of polytetrafluoroethylene (PTFE") and polydimethylsiloxane ("PDMS") by causing a matrix of PDMS to be formed in situ with a matrix of PTFE (11) and causing surface of substantially pure PDMS to be formed on at least one side thereof (12), allowing PDMS compositions to vulcanize. The product of the process is suitable for the treatment of dermatologic scars.
Description
WO 9S/22997 . _I~L ~7 SCAR TREATMENT SHEETING AND METHOD OF MANUFACTURE
R'~ OF THE 1~ v 1. Piel~ of th~ InventiQ~
The present invention relates to the tre2tment of dermatologic scars, and more particularly co~.ornc scar treatment ~:hPetin~ and other articles, and a method of manufacture thereof.
R'~ OF THE 1~ v 1. Piel~ of th~ InventiQ~
The present invention relates to the tre2tment of dermatologic scars, and more particularly co~.ornc scar treatment ~:hPetin~ and other articles, and a method of manufacture thereof.
2. DescriDtion of the Prior ~rt Silicone chemistry has evolved since the early 1900' s into a wide variety of systems used for industrial as well as medical applications. ~edical grade s;l ;c~ nF~ are usually based on thl --et dimethyl systems, whereby the molecular formula may be represented as follows:
SUBSTITUTE SHEET (RULE 26) W0 9512299~ o 2183~93 5 ' ' CH3 CH3 CH3 CH3 I
-- si -- o -- si -- o -- si -- o -- si -- o --A crosslinking agent is used to create bonds between the hydrogen atoms on the methyl groups of adjacent molecules. These silicone formulations are often supplied as a two(2) part system, wherein one part contains a catalyst for vulcanization and the other part contains the base resin and crosslinking agent. By varying the amount of crosslinking agent, the crosslink density may be adjusted to achieve desired bulk or surface qualities of the vulcanized elastomer. Physical strength and durability tend to increase, while softness and coefficient of friction decrease with higher crosslink densities. Materials with a high crosslink density are relatively slick and tough, but have poor compliancy or " drapability~ . Silicones with low crosslink densities give a soft gel with a more adhesive or tacky" surface. These materials are more drapable, although they are inherently weak and tend to fragment easily with low levels of stress.
A number of U.S. Patents and other publications relate to the field of the invention, and are as f ollows:
SUBSTITUTE SHEET (RULE 26) W0 9512299~ o 2183~93 5 ' ' CH3 CH3 CH3 CH3 I
-- si -- o -- si -- o -- si -- o -- si -- o --A crosslinking agent is used to create bonds between the hydrogen atoms on the methyl groups of adjacent molecules. These silicone formulations are often supplied as a two(2) part system, wherein one part contains a catalyst for vulcanization and the other part contains the base resin and crosslinking agent. By varying the amount of crosslinking agent, the crosslink density may be adjusted to achieve desired bulk or surface qualities of the vulcanized elastomer. Physical strength and durability tend to increase, while softness and coefficient of friction decrease with higher crosslink densities. Materials with a high crosslink density are relatively slick and tough, but have poor compliancy or " drapability~ . Silicones with low crosslink densities give a soft gel with a more adhesive or tacky" surface. These materials are more drapable, although they are inherently weak and tend to fragment easily with low levels of stress.
A number of U.S. Patents and other publications relate to the field of the invention, and are as f ollows:
U . S . PATENT DOCUMENTS
4, 832, 009 5/23/89 D_llon 4 945 125 7/31/90 D_llon et al.
5 5 066 683 11~19/91 D_llon et al.
5,157,058 10/20/92 D_llon et al.
OTHER PUBLICATIONS
Sperling, InteL~ L~atin~r Polymer Networks and Related Mater1AlR, Plenum Press, New York, 1981, pp.
10 1-5.
Dillon, ME, Okunski, WJ, ~ Silon Non-Adherent Film Dressings on Autograft and Donor Sites', ~523a~, 1992, vol . 4, no . 5: 203-207 .
Dillon, ME, ~Silicone and Poly(tetrafluoroethylene~
Interpenetrating Polymer Networks: Brief History, Summary of Recent Developments, and DiCCI7CSi n7,7 0 Applications', Inter7~n~tratinn PolYmer IJ~L~L~.
Klempner et al. ed, ACS Books, New York, NY, 1991, pp. 393-404.
Perkins, et. al., ~Silicone Gel: A New Treatment for Burn Scars and Contractures", Burns, 1982, 9, pp.
201 .
Quinn, KJ, ~ Silicone Gel in Scar Treatment', Burns, 1987, 13, pp. 33-40.
This invention relates to the tlea, -nt of dermatologic scars associated with traumatic or surgical injuries by using silicone elastomer materials. In many cases, scar formation may be excessive, resulting in raised, textured or colored WO 95/2~99~ '7147 O
21~
surfaces. Scars can not only be disfiguring, but also limit range oP motion and functionality. Historically, the application of ~a6DuL~ to an affected area of the body has been used to minimize these effects, particularly regarding ~y~elLL.,~hic and keloidal scars.
~`.A ~ LS made of an elastic textile are used to achieve such p~LDULt:. This method of treatment eventually became a standard of care in many medical institutions, particularly burn treatment centers.
An Australian research group reported using silicone gel under ~el~UL~ gA ~I LS to evenly apply plessu t in anatomic depressions, over areas of flexure, and during ambulation (Perkins et al., 1982). Quinn (1987) later found that the efficacy of silicone for scar modification was unrelated to ~resDuL~:~ in that the silicone material itself had a beneficial effect on the cosmetic appearance and elasticity of scars. The exact biological -n; F~
of this effect is not well ul.~eLDLood.
In recent years, two (2) general types of silicone sheeting products have gained commercial acceptance in the marketplace for scar modification applications. One of the first types, Silastic (Dow Corning Corporation) consists of a soft polydimethylsiloxane ("PDMS~') gel material of approximately 0.125 inch (0.32 cm) in ~h~r~kn~ . The low modulus of elasticity is wo g~ 997 . ~ ~ 47 5~ 2183993 beneficial by providing surface tack, thus promoting skin contact on difficult anatomical areas or during - ~ I t . The PDMS composition is inherently weak, however, and endures only several days in practice before breaking apart because of mechanical agitation. The above mentioned product use6 a reinforcing scrim: ''ec~ into the body of the material to improve durability. This macroscopic mesh complicates the manufacturing process and may cause skin irritation if exposed during use.
Although durability is increased, these products still disintegrate from normal wear and tear within a matter of weeks. This is a limiting factor in the cost effectiveness of the product in that the treatment may last for several months, thus requiring numerous repurchases. Together, the scrim and thickness of the product ~ e drapability and comf ort f eatures .
The second type of ~ ial product, such as Sil~ egania Silicone, Ltd. ), consists of a relatively stiff silicone elastomer of approximately O . 03 inches ( O . 08 cm) in th ~ c- n~ . The increased modulus of elasticity provides for increased physical strength and durability, and the lack of a reinforcing scrim simplifies the manufacturing process. The material is relatively non-adherent, so adhesive tape is typically used to maintain the _ _ .
WO 95122997 rc o 218399~
position of the material on the body. Although this material may last for the duration of LLt aL 1, it does not conform well to anatomical areas and does not provide a high level of patient comfort. This i ~es patient compliancy and may limit the efricacy of the treatment.
Both types of products are relatively occlusive and i _- oble to moisture vapor, which further lo detracts from patient comfort. There are other silicone-based scar treatment materials which have been commercialized, each generally falling into one of the two categories above. Some of the important properties of the above two examples of commercial products are listed in Table VII.
Ve~i n 1 tions Moisture Vapor Transmission The rate at which water vapor Rate permeates through a material calculated gravimetrically and expressed in units of g/m2/day.
The test conditions are 50%
relative humidity, 98-F (37-C), with an air rlow of 650 cubic feet per minute over the sp~c i WO 95122991 ~ . == = = . - PCTIUS95/02147 Tensile Strength The load required to break a test specimen divided by the cross-sectional area of the specimen .
Modulus of Elasticity The tensile strength of a material at break divided by the elongation at break.
Coefficient of Friction The force, measured in pounds, required to initiate the slide of a 1 inch square (6.45 cm2) by 0.5 inch (1.27 cm) thick piece of high density polyethylene over a test specimen on a horizontal surface.
Drapability The distance the edge of a length of material bends when extended one inch beyond the surface of a ridged support with a corner radius of less than l/16th inch.
Woss/22~s7 2 1 8 3 9 9 3 p ~ ; A?147 nUllNARY OF Ti~E: lh~J~n Interpenetrating polymer n~L~ are defined as a blend of two or more polymers where each material forms a continuous network, each network interpenetrating the other (Sperling, 1981). An IPN is therefore a type of polymer/polymer composite. A true IPN comprises polymeric ingredients which are inrl,-r~ rl-~,tly crosslinked. Systems wherein only one component is crosslinked are called semi-IPNs or pseudo-IPNs, such as an IPN of a linear th~ ctic polymer and a thermoset elastomer. For the purposes of this discussion, the terms IPN, semi-IPN, and pseudo-IPN shall be used interrh;-n~ bly.
Because of the nature of composite materials, synergistic effects may be gained by carefully engineering the morphology and chemistry of the polymers in an IPN. My previous patents on this subject c'~~ Llclte increased strength may be gained without sacrificing other important properties, such as breathability. By using PDMS and polytetrafluoroethylene ("PTFE"), an IPN with a modulus of elasticity and surface chemistry sub6tantially comprised of PDMS may be produced while also possessing the strength and durability of PTFE. The resultant material is semipermeable in that it allows moisture vapor transmission while preventing liquid water break-through. This WOg~il22997 1`,I/~J.. 3' 17 technology has provided skin-like bandages and dressing materials for woundcare applications such 5 as burn tLq:a, L (Dillon et al ., 1992 , FDA 510 [k]
approval no. K912032).
I have unexpectedly discovered that an IPN of PDMS and PTFE may be used as the basis of an elastomeric sheet useful for scar treatment applications. The subject of this invention allows the opposing properties of strength and softness in silicones elastomers to be simultaneously achieved;
e.g. durability may be combined with drapability and surface tack. Furt~ , by causing one side of the structure to have a greater silicone content than the other, disparate surface properties may be imparted to each surface. The subject of the present invention represents an i lU~i~ t. over prior art in that the product:
1. is soft and compliant, 2. is strong and durable, 3. has a thinner profile, 4. has disparate surface properties , on each side, 5. is moisture vapor permeable, and 6. has greater com~ort features.
WO 95122997 . _ I / IJ ,, 17 o 21839~3 The manufacturing process lends itself to large-scale production in that continuous rolls of material may be made in virtually unlimited lengths.
This provides for rapid and cost effective conversion into die-cut shapes or self-wound rolls.
B~IEP DL_CAl~.lON OF THE DAAWING~
Fig. l is a view in cross section of a sheet c.,..a~L-.~Led in accordance with this invention;
Fig. 2 is a view in top plan of a face mask constructed in accordance with this invention;
Fig. 3 is a view in top plan of a sheet which includes holes adapted for applying l Leai -~-t to the webbed spaces between f ingers or toes;
Fig. 4 shows a sheet which has perforations to facilitate the transfer of body heat through the sheet to thereby promote patient comfort; and Fig . 5 shows a view in section of a " f inger cot" for application to the digits of the hand or other anatomical protrusions.
Dl~T~TTT!n DBv_AI~uN OF THE r~
Several ' ';- Ls of this invention are shown in the following illustrative examples and are not intended to be limiting. The following two-part silicone compositions were used in each example:
wo 95~997 PcrluS9S/02147 TABI,E I
Type: Catalyst/ Description:
Re~in Ratio Sllastic Silicone 1:10 High crosslink density, high 5 MDX4-4210 modulus of el~sticity, hiqh Doll Corn~n9 Corpor~t~on tensile strength, low c o~ff;riPr-t of friction Silastic Silicone 1:1 Low crosslink density, low Q7-2218 modulus of elasticlty, low Doll Corn~ng Corpor~t~on tensile strength, high coefficient of friction The following blend of PD2~S materials was prepnred using trichloroethane as a processing aid:
SUBSTITUTE SHEET IRULE 26) 7 2 1 8 3 9 9 3 1 2 1 ~ 7 0 . ~. . .:
TABLE II
PDNS Materlal Weight(g Percent Q7-Z218 Part 11 150.4 38.9 Q7-2218 Part B 150 . 4 38 . 9 MDX4-4210Pnrt ~ 21.8 5.6 Trichl~ ' ' 63 . 7 16 . 5 An IPN f ilm of PDHS and PTFE was produced in the form of a continuous roll 12 inches (30 cm) wide according to the methods described in U . S . Patent number 4,945,125, the disclosures of which are u" u. ~1 herein by reference. Approximately 0 . 9 g of PTFE (Te~ c Corporstion~ was used per linear foot of IPN f ilm produced . The IPN f ilm was measured to have a thirkno~s of 0.ûOl lnches (0.û025 cm). The properties of this material are glven in Table VII.
A second blend of PDMS materials was prepared as f ollows:
SUBSTITUTE SHEET (RULE 26) WO 9~i/22997 - ~ PCI~IJ595~02147 - TABLE III
PDMS Material Weight(g~ Percent Q7-2218 Part A 242.5 25.0 Q7--2218 Part B 242 . 5 25 . 0 MDX4-4210Part A 440,9 45,5 MDX4-4210Part B 44.1 4.5 A casting process was used to apply a 0. 01 inch (0. 025 cm) surface coating of the above PDMS
composition to one side of the IPN film. The casting process involved paCsing the ~ LLc~te through a reservoir of liquid PDMS prepolymer and using a doctoring roll to meter off a controlled amount of liquid as to leave a precise ~hiokn~:A of PDMS on the surface of the IPN ~ub:,LL~Ite. Numerous other methods of achieving such a coating will be apparent to those skilled in the art. The coated material was passed through a tunnel style oven as to initiate the curing process, then post cured in a closed oven for 3 hours at 158'F (70-C~ to achieve full vulcanization. Figure 1 shows a sectional view of the ~ ,LL..~ion of this example, with IPN layer 11 and PDMS coating 12. For WO 95/22997 1 .,~ 7 ' ' ': `'' comparative purposes, the same process was used to create 0. 01 inch tO. 025 cm) sheet of the same PDNS
material without the bottom layer of IPN f ilm . A paper release liner (H. P. Smith Company) was used as a temporary :~ub:7LLte from which the PDNS sheet was later removed. Some of the important physical characteristics of each material produced by this example are given in Table VII.
The following blend of PDMS materials was produced:
~ W09512~997 ~5 r.,~ 3,. 147 TABLE V
PDMS Material Weight(g Percen t Q7-2218 Part A 44.0 4.0 Q7-2218 Part ~ 44 . 0 4 . o MDX4 -4 2 l o Part A 3 2 0 . 0 2 9 . 1 MDX4-4210Part ~ 32.0 2.9 Trichloroethane 660, 0 60. 0 An IPN film of PDMS and PTFE was ~roduced in the form of a continuous roll 12 inches (30 cm) wide using the PDMS blend of Table V according to the methods previously described. Approximately 1. 3 g of PTFE
(Tetratec Corporation) was used per linear foot of IPN
film produced. The final IPN was measured to have a thickness of 0.002 inches (0.05 cm).
A second blend of PDMS materials were prepared as follows:
WO95/22997 .. 1/l 17 21839~3 0 TABLE VI
PDMS Material Weight(g Percent (g) Q7-2218 Part A 232 . 5 25 . O
5Q7-2218 Part B 232 . 5 25 . O
MDX4-4210 Part A 422.7 45.5 MDX4--4210Part B 42.3 4.5 The process outlined above was used to apply a a 0.036 lnch (0.091 cm) surface coating of the above PDMS blend to one side of the IPN f ilm . As with the previous example, the material wa6 passed through tunnel style oven as to initiate the curing process, then post-cured in a closed oven for 3 hours at 158F
(70- C). Again the same process was used to create O . 03 inch (O . 075 cm) sheet of the same PDMS material without the bottom layer of IPN f ilm . Some of the important physical characteristics of the materials ~, uduced by this example are given in Table VII .
The above samples are preferred embodiments of this invention. Other formulations and constructions will be apparent to thosc skilled in the art. For example, there are many other ~c~l ir/~n~ compositions that would be suitable for the subject of this invention, either in combination or in blends. Dow Corning Silastic- grades MDX4--4515, Q7--2213, Q7--2167, Q7--2168, Q7-2174, Q7--2245, Q7--4840, and Q7-4850 are suitable substitutes. FUrth :, various thi~knocc~c of IPN films and silicone coatings may be useful. The range of suitable IPN thickness is between 0.0005 inch (12.5 microns) and 0.02 inch (o.05 cm), and that for the PDMS is between 0. 005 inch (0 . 0125 cm) and 0 . 25 inch (0.64 cm). An important consideration is that the final cu-l~LL~l- Lion is not so thin as to have a tendency to wrinkle or otherwise be difficult to handle. The steps of creating a layered article may be reversed or even consolidated into one process.
In addition to various compositions, there are numerous shapes and sizes useful for the subject of this invention.
For example, the invention may be converted into sheets or rolls for final use. Other ~ Ls include face-mask designs as shown in top plan view in Figure 2 which shows a face mask 21 with cut op~nin~c 22 which ac_ '-te the features of the face. An WO 95/22997 1 ~,lltl.. -' ~147 . . `.
additional : _ ' i nt is shown in top plan view in Figure 3, wherein a sheet 31 includes holes 32 cut as to apply treatment to the web-spaces between f ingers and toes. Yet another : '; ~ is shown in Figure 4 where a sheet 41 has perforations 42 to facilitate the transfer of body heat through the sheet 41, thereby promoting patient comfort.
A particularly novel configuration of this invention is a ~ finger cot~ for application to the digits of the hand or other anatomical protrusions.
Figure 5 shows a sectional view of this: ;- L and shows a mandrill 51 covered by an inventive article 52.
This configuration may be achieved by~ conforming --or forming-- a PTFE/PDMS IPN article around the end of a suitable mandrill, (2) dipping the mandrill in a reservoir of uncured polysiloxane, (3) removing the mandrill from the reservoir, (4) allowing the residual surface coating of polysiloxane to vulcanize, (5) 20 removing the polysiloxane coated IPN article by peeling it off of the mandrill as it is turned in-side-out, and (6) (optionally) rolling the mouth of the shaped article outward and back to facilitate application by rolling the mouth of the product back down over the WO 95122997 PCT/[JS95~02l47 21839~
anatomical protrusion.
W0 95/22997 2 1 8 3 9 9 3 . ~ ., 5~7~47 0 ' :
s O r O
O Ul ~ ~ O ~ ~ O
P~ _ O ~ In ~~
~r ~ 'r ~ co O~
- o' d o o o' o' o - ,~
O~ o ~ , o fi ~ x 'O r~
S g o o o SUBSTITUTE SHEET (RULE 26)
5,157,058 10/20/92 D_llon et al.
OTHER PUBLICATIONS
Sperling, InteL~ L~atin~r Polymer Networks and Related Mater1AlR, Plenum Press, New York, 1981, pp.
10 1-5.
Dillon, ME, Okunski, WJ, ~ Silon Non-Adherent Film Dressings on Autograft and Donor Sites', ~523a~, 1992, vol . 4, no . 5: 203-207 .
Dillon, ME, ~Silicone and Poly(tetrafluoroethylene~
Interpenetrating Polymer Networks: Brief History, Summary of Recent Developments, and DiCCI7CSi n7,7 0 Applications', Inter7~n~tratinn PolYmer IJ~L~L~.
Klempner et al. ed, ACS Books, New York, NY, 1991, pp. 393-404.
Perkins, et. al., ~Silicone Gel: A New Treatment for Burn Scars and Contractures", Burns, 1982, 9, pp.
201 .
Quinn, KJ, ~ Silicone Gel in Scar Treatment', Burns, 1987, 13, pp. 33-40.
This invention relates to the tlea, -nt of dermatologic scars associated with traumatic or surgical injuries by using silicone elastomer materials. In many cases, scar formation may be excessive, resulting in raised, textured or colored WO 95/2~99~ '7147 O
21~
surfaces. Scars can not only be disfiguring, but also limit range oP motion and functionality. Historically, the application of ~a6DuL~ to an affected area of the body has been used to minimize these effects, particularly regarding ~y~elLL.,~hic and keloidal scars.
~`.A ~ LS made of an elastic textile are used to achieve such p~LDULt:. This method of treatment eventually became a standard of care in many medical institutions, particularly burn treatment centers.
An Australian research group reported using silicone gel under ~el~UL~ gA ~I LS to evenly apply plessu t in anatomic depressions, over areas of flexure, and during ambulation (Perkins et al., 1982). Quinn (1987) later found that the efficacy of silicone for scar modification was unrelated to ~resDuL~:~ in that the silicone material itself had a beneficial effect on the cosmetic appearance and elasticity of scars. The exact biological -n; F~
of this effect is not well ul.~eLDLood.
In recent years, two (2) general types of silicone sheeting products have gained commercial acceptance in the marketplace for scar modification applications. One of the first types, Silastic (Dow Corning Corporation) consists of a soft polydimethylsiloxane ("PDMS~') gel material of approximately 0.125 inch (0.32 cm) in ~h~r~kn~ . The low modulus of elasticity is wo g~ 997 . ~ ~ 47 5~ 2183993 beneficial by providing surface tack, thus promoting skin contact on difficult anatomical areas or during - ~ I t . The PDMS composition is inherently weak, however, and endures only several days in practice before breaking apart because of mechanical agitation. The above mentioned product use6 a reinforcing scrim: ''ec~ into the body of the material to improve durability. This macroscopic mesh complicates the manufacturing process and may cause skin irritation if exposed during use.
Although durability is increased, these products still disintegrate from normal wear and tear within a matter of weeks. This is a limiting factor in the cost effectiveness of the product in that the treatment may last for several months, thus requiring numerous repurchases. Together, the scrim and thickness of the product ~ e drapability and comf ort f eatures .
The second type of ~ ial product, such as Sil~ egania Silicone, Ltd. ), consists of a relatively stiff silicone elastomer of approximately O . 03 inches ( O . 08 cm) in th ~ c- n~ . The increased modulus of elasticity provides for increased physical strength and durability, and the lack of a reinforcing scrim simplifies the manufacturing process. The material is relatively non-adherent, so adhesive tape is typically used to maintain the _ _ .
WO 95122997 rc o 218399~
position of the material on the body. Although this material may last for the duration of LLt aL 1, it does not conform well to anatomical areas and does not provide a high level of patient comfort. This i ~es patient compliancy and may limit the efricacy of the treatment.
Both types of products are relatively occlusive and i _- oble to moisture vapor, which further lo detracts from patient comfort. There are other silicone-based scar treatment materials which have been commercialized, each generally falling into one of the two categories above. Some of the important properties of the above two examples of commercial products are listed in Table VII.
Ve~i n 1 tions Moisture Vapor Transmission The rate at which water vapor Rate permeates through a material calculated gravimetrically and expressed in units of g/m2/day.
The test conditions are 50%
relative humidity, 98-F (37-C), with an air rlow of 650 cubic feet per minute over the sp~c i WO 95122991 ~ . == = = . - PCTIUS95/02147 Tensile Strength The load required to break a test specimen divided by the cross-sectional area of the specimen .
Modulus of Elasticity The tensile strength of a material at break divided by the elongation at break.
Coefficient of Friction The force, measured in pounds, required to initiate the slide of a 1 inch square (6.45 cm2) by 0.5 inch (1.27 cm) thick piece of high density polyethylene over a test specimen on a horizontal surface.
Drapability The distance the edge of a length of material bends when extended one inch beyond the surface of a ridged support with a corner radius of less than l/16th inch.
Woss/22~s7 2 1 8 3 9 9 3 p ~ ; A?147 nUllNARY OF Ti~E: lh~J~n Interpenetrating polymer n~L~ are defined as a blend of two or more polymers where each material forms a continuous network, each network interpenetrating the other (Sperling, 1981). An IPN is therefore a type of polymer/polymer composite. A true IPN comprises polymeric ingredients which are inrl,-r~ rl-~,tly crosslinked. Systems wherein only one component is crosslinked are called semi-IPNs or pseudo-IPNs, such as an IPN of a linear th~ ctic polymer and a thermoset elastomer. For the purposes of this discussion, the terms IPN, semi-IPN, and pseudo-IPN shall be used interrh;-n~ bly.
Because of the nature of composite materials, synergistic effects may be gained by carefully engineering the morphology and chemistry of the polymers in an IPN. My previous patents on this subject c'~~ Llclte increased strength may be gained without sacrificing other important properties, such as breathability. By using PDMS and polytetrafluoroethylene ("PTFE"), an IPN with a modulus of elasticity and surface chemistry sub6tantially comprised of PDMS may be produced while also possessing the strength and durability of PTFE. The resultant material is semipermeable in that it allows moisture vapor transmission while preventing liquid water break-through. This WOg~il22997 1`,I/~J.. 3' 17 technology has provided skin-like bandages and dressing materials for woundcare applications such 5 as burn tLq:a, L (Dillon et al ., 1992 , FDA 510 [k]
approval no. K912032).
I have unexpectedly discovered that an IPN of PDMS and PTFE may be used as the basis of an elastomeric sheet useful for scar treatment applications. The subject of this invention allows the opposing properties of strength and softness in silicones elastomers to be simultaneously achieved;
e.g. durability may be combined with drapability and surface tack. Furt~ , by causing one side of the structure to have a greater silicone content than the other, disparate surface properties may be imparted to each surface. The subject of the present invention represents an i lU~i~ t. over prior art in that the product:
1. is soft and compliant, 2. is strong and durable, 3. has a thinner profile, 4. has disparate surface properties , on each side, 5. is moisture vapor permeable, and 6. has greater com~ort features.
WO 95122997 . _ I / IJ ,, 17 o 21839~3 The manufacturing process lends itself to large-scale production in that continuous rolls of material may be made in virtually unlimited lengths.
This provides for rapid and cost effective conversion into die-cut shapes or self-wound rolls.
B~IEP DL_CAl~.lON OF THE DAAWING~
Fig. l is a view in cross section of a sheet c.,..a~L-.~Led in accordance with this invention;
Fig. 2 is a view in top plan of a face mask constructed in accordance with this invention;
Fig. 3 is a view in top plan of a sheet which includes holes adapted for applying l Leai -~-t to the webbed spaces between f ingers or toes;
Fig. 4 shows a sheet which has perforations to facilitate the transfer of body heat through the sheet to thereby promote patient comfort; and Fig . 5 shows a view in section of a " f inger cot" for application to the digits of the hand or other anatomical protrusions.
Dl~T~TTT!n DBv_AI~uN OF THE r~
Several ' ';- Ls of this invention are shown in the following illustrative examples and are not intended to be limiting. The following two-part silicone compositions were used in each example:
wo 95~997 PcrluS9S/02147 TABI,E I
Type: Catalyst/ Description:
Re~in Ratio Sllastic Silicone 1:10 High crosslink density, high 5 MDX4-4210 modulus of el~sticity, hiqh Doll Corn~n9 Corpor~t~on tensile strength, low c o~ff;riPr-t of friction Silastic Silicone 1:1 Low crosslink density, low Q7-2218 modulus of elasticlty, low Doll Corn~ng Corpor~t~on tensile strength, high coefficient of friction The following blend of PD2~S materials was prepnred using trichloroethane as a processing aid:
SUBSTITUTE SHEET IRULE 26) 7 2 1 8 3 9 9 3 1 2 1 ~ 7 0 . ~. . .:
TABLE II
PDNS Materlal Weight(g Percent Q7-Z218 Part 11 150.4 38.9 Q7-2218 Part B 150 . 4 38 . 9 MDX4-4210Pnrt ~ 21.8 5.6 Trichl~ ' ' 63 . 7 16 . 5 An IPN f ilm of PDHS and PTFE was produced in the form of a continuous roll 12 inches (30 cm) wide according to the methods described in U . S . Patent number 4,945,125, the disclosures of which are u" u. ~1 herein by reference. Approximately 0 . 9 g of PTFE (Te~ c Corporstion~ was used per linear foot of IPN f ilm produced . The IPN f ilm was measured to have a thirkno~s of 0.ûOl lnches (0.û025 cm). The properties of this material are glven in Table VII.
A second blend of PDMS materials was prepared as f ollows:
SUBSTITUTE SHEET (RULE 26) WO 9~i/22997 - ~ PCI~IJ595~02147 - TABLE III
PDMS Material Weight(g~ Percent Q7-2218 Part A 242.5 25.0 Q7--2218 Part B 242 . 5 25 . 0 MDX4-4210Part A 440,9 45,5 MDX4-4210Part B 44.1 4.5 A casting process was used to apply a 0. 01 inch (0. 025 cm) surface coating of the above PDMS
composition to one side of the IPN film. The casting process involved paCsing the ~ LLc~te through a reservoir of liquid PDMS prepolymer and using a doctoring roll to meter off a controlled amount of liquid as to leave a precise ~hiokn~:A of PDMS on the surface of the IPN ~ub:,LL~Ite. Numerous other methods of achieving such a coating will be apparent to those skilled in the art. The coated material was passed through a tunnel style oven as to initiate the curing process, then post cured in a closed oven for 3 hours at 158'F (70-C~ to achieve full vulcanization. Figure 1 shows a sectional view of the ~ ,LL..~ion of this example, with IPN layer 11 and PDMS coating 12. For WO 95/22997 1 .,~ 7 ' ' ': `'' comparative purposes, the same process was used to create 0. 01 inch tO. 025 cm) sheet of the same PDNS
material without the bottom layer of IPN f ilm . A paper release liner (H. P. Smith Company) was used as a temporary :~ub:7LLte from which the PDNS sheet was later removed. Some of the important physical characteristics of each material produced by this example are given in Table VII.
The following blend of PDMS materials was produced:
~ W09512~997 ~5 r.,~ 3,. 147 TABLE V
PDMS Material Weight(g Percen t Q7-2218 Part A 44.0 4.0 Q7-2218 Part ~ 44 . 0 4 . o MDX4 -4 2 l o Part A 3 2 0 . 0 2 9 . 1 MDX4-4210Part ~ 32.0 2.9 Trichloroethane 660, 0 60. 0 An IPN film of PDMS and PTFE was ~roduced in the form of a continuous roll 12 inches (30 cm) wide using the PDMS blend of Table V according to the methods previously described. Approximately 1. 3 g of PTFE
(Tetratec Corporation) was used per linear foot of IPN
film produced. The final IPN was measured to have a thickness of 0.002 inches (0.05 cm).
A second blend of PDMS materials were prepared as follows:
WO95/22997 .. 1/l 17 21839~3 0 TABLE VI
PDMS Material Weight(g Percent (g) Q7-2218 Part A 232 . 5 25 . O
5Q7-2218 Part B 232 . 5 25 . O
MDX4-4210 Part A 422.7 45.5 MDX4--4210Part B 42.3 4.5 The process outlined above was used to apply a a 0.036 lnch (0.091 cm) surface coating of the above PDMS blend to one side of the IPN f ilm . As with the previous example, the material wa6 passed through tunnel style oven as to initiate the curing process, then post-cured in a closed oven for 3 hours at 158F
(70- C). Again the same process was used to create O . 03 inch (O . 075 cm) sheet of the same PDMS material without the bottom layer of IPN f ilm . Some of the important physical characteristics of the materials ~, uduced by this example are given in Table VII .
The above samples are preferred embodiments of this invention. Other formulations and constructions will be apparent to thosc skilled in the art. For example, there are many other ~c~l ir/~n~ compositions that would be suitable for the subject of this invention, either in combination or in blends. Dow Corning Silastic- grades MDX4--4515, Q7--2213, Q7--2167, Q7--2168, Q7-2174, Q7--2245, Q7--4840, and Q7-4850 are suitable substitutes. FUrth :, various thi~knocc~c of IPN films and silicone coatings may be useful. The range of suitable IPN thickness is between 0.0005 inch (12.5 microns) and 0.02 inch (o.05 cm), and that for the PDMS is between 0. 005 inch (0 . 0125 cm) and 0 . 25 inch (0.64 cm). An important consideration is that the final cu-l~LL~l- Lion is not so thin as to have a tendency to wrinkle or otherwise be difficult to handle. The steps of creating a layered article may be reversed or even consolidated into one process.
In addition to various compositions, there are numerous shapes and sizes useful for the subject of this invention.
For example, the invention may be converted into sheets or rolls for final use. Other ~ Ls include face-mask designs as shown in top plan view in Figure 2 which shows a face mask 21 with cut op~nin~c 22 which ac_ '-te the features of the face. An WO 95/22997 1 ~,lltl.. -' ~147 . . `.
additional : _ ' i nt is shown in top plan view in Figure 3, wherein a sheet 31 includes holes 32 cut as to apply treatment to the web-spaces between f ingers and toes. Yet another : '; ~ is shown in Figure 4 where a sheet 41 has perforations 42 to facilitate the transfer of body heat through the sheet 41, thereby promoting patient comfort.
A particularly novel configuration of this invention is a ~ finger cot~ for application to the digits of the hand or other anatomical protrusions.
Figure 5 shows a sectional view of this: ;- L and shows a mandrill 51 covered by an inventive article 52.
This configuration may be achieved by~ conforming --or forming-- a PTFE/PDMS IPN article around the end of a suitable mandrill, (2) dipping the mandrill in a reservoir of uncured polysiloxane, (3) removing the mandrill from the reservoir, (4) allowing the residual surface coating of polysiloxane to vulcanize, (5) 20 removing the polysiloxane coated IPN article by peeling it off of the mandrill as it is turned in-side-out, and (6) (optionally) rolling the mouth of the shaped article outward and back to facilitate application by rolling the mouth of the product back down over the WO 95122997 PCT/[JS95~02l47 21839~
anatomical protrusion.
W0 95/22997 2 1 8 3 9 9 3 . ~ ., 5~7~47 0 ' :
s O r O
O Ul ~ ~ O ~ ~ O
P~ _ O ~ In ~~
~r ~ 'r ~ co O~
- o' d o o o' o' o - ,~
O~ o ~ , o fi ~ x 'O r~
S g o o o SUBSTITUTE SHEET (RULE 26)
Claims (29)
1. A composite article for treating dermatologic scars, comprising a first layer of a crosslinked elastomer, and a second layer of a membranous film.
2. The article of Claim 1, wherein the membranous film is a semi-interpenetrating polymer network of polydimethylsiloxane and polytetrafluoroethylene.
3. The article of Claim 1, wherein the crosslinked elastomer is polydimethylsiloxane.
4. The article of Claim 1, wherein each layer has surface characteristics that are disparate from the other layer.
5. The article of Claim 1, having a minimum moisture vapor transmission rate of 51.9 g/m/day.
6. The article of Claim 1, having a minimum drapability of 0.88 inches.
7. The article of Claim 1, with a modulus of elasticity of less than or equal to 38.1 lbs/in.
8. The article of Claim 2, wherein each layer has surface characteristics that are disparate from the other layer.
9. The article of Claim 2, having a minimum moisture vapor transmission rate of 51.9 g/m/day.
10. The article of Claim 2, with a drapability of at least 0.88 inches.
11. The article of Claim 2, with a modulus of elasticity of less than or equal to 38.1 lbs/in.
12. The article of Claim 3, wherein each layer has surface characteristics that are disparate from the other layer.
13. The article of Claim 3, having a minimum moisture vapor transmission rate of 51.9 g/m/day.
14. The article of Claim 3, having a minimum drapability of 0.88 inches.
15. The article of Claim 3, with a modulus of elasticity of less than or equal to 38.1 lbs/in2.
16. The article of Claim 3, wherein the layer of polydimethylsiloxane is 0.01 inches thick.
17. The article of Claim 3, wherein the layer of polydimethylsiloxane is 0.03 inches thick.
18. The article of Claim 2, wherein the semi-interpenetrating polymer network is 0.001 inches thick.
19. The article of Claim 2, wherein the semi-interpenetrating polymer network is 0.002 inches thick.
20. A process which comprises the steps of (1) forming a membranous film, (2) causing a surface of substantially pure polysiloxane to be formed on at least one side thereof to form a composite structure, and (3) converting said structure into shapes for covering anatomical areas of the body.
21. The process of Claim 20, including applying said shapes to dermatologic scars.
22. The process of Claim 20, wherein the membranous film is an interpenetrating polymer network of polysiloxane and polytetrafluoroethylene.
23. The process of Claim 21, wherein the shapes have holes to accommodate fingers, toes or other anatomical protrusions of the body.
24. The process of Claim 21, wherein the shapes are configured in a face-mask fashion.
25. The process of Claim 21, wherein the shapes have perforations to promote heat transfer form the body.
26. The process of Claim 21, wherein the shapes are configured in the fashion of a finger cot.
27. A composite article for treating dermatologic scars comprising a first layer of a crosslinked elastomer, and a second layer of a membranous film, the membranous film being a semi-interpenetrating polymer network of polydimethylsiloxane and polytetrafluoroethylene, the crosslinked elastomer being polydimethylsiloxane, wherein each layer has surface characteristics that are disparate form the other layer, the layer of polydimethylsiloxane being 0.01 inches thick, and the semi-interpenetrating polymer network being 0.001 inches thick.
28. A process which comprises the steps of (1) forming a membranous film, (2) causing a surface of substantially pure polysiloxane to be formed on at least one side thereof to form a composite structure, and (3) converting said structure into shapes for covering anatomical areas of the body, said membranous film being an interpenetrating polymer network of polysiloxane and polytetrafluoroethylene, said shapes have holes to accommodate fingers, toes or other anatomical protrusions, and said shapes have perforations so as to promote heat transfer from the body.
29. The process of claim 28, wherein the shapes are configured in the fashion of a finger cot.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/200,152 US5656279A (en) | 1994-02-23 | 1994-02-23 | Semi-interpenetrating polymer network scar treatment sheeting, process of manufacture and useful articles thereof |
| US08/200,152 | 1994-02-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2183993A1 true CA2183993A1 (en) | 1995-08-31 |
Family
ID=22740548
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002183993A Abandoned CA2183993A1 (en) | 1994-02-23 | 1995-02-23 | Scar treatment sheeting and method of manufacture |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US5656279A (en) |
| EP (1) | EP0746341B1 (en) |
| JP (1) | JP3739394B2 (en) |
| AU (1) | AU1880195A (en) |
| CA (1) | CA2183993A1 (en) |
| DE (1) | DE69532990T2 (en) |
| DK (1) | DK0746341T3 (en) |
| WO (1) | WO1995022997A1 (en) |
Families Citing this family (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5656279A (en) * | 1994-02-23 | 1997-08-12 | Bio Med Sciences, Inc. | Semi-interpenetrating polymer network scar treatment sheeting, process of manufacture and useful articles thereof |
| US8084051B1 (en) * | 1995-11-13 | 2011-12-27 | Bio Med Sciences, Inc. | Therapeutic medical garments with silicone sheeting component for scar treatment, process of manufacture and use |
| GB9902808D0 (en) | 1998-05-06 | 1999-03-31 | Dow Corning Sa | Adhesive device |
| DE19829712A1 (en) * | 1998-07-03 | 2000-01-05 | Lohmann Therapie Syst Lts | Dressing for inhibiting scar tissue formation |
| US6465074B1 (en) * | 1999-08-25 | 2002-10-15 | Albany International Corp. | Base substrates for coated belts |
| IL150569A0 (en) * | 2000-01-03 | 2003-02-12 | Biomed Sciences Inc | Wound dressing and process for the manufacture thereof |
| DE10017530A1 (en) * | 2000-04-10 | 2001-10-18 | Suwelack Skin & Health Care Ag | Mask made of flexible carrier suitable for fluid absorption, care set containing this mask, process for the production of a mask and process for cosmetic treatment using this mask |
| US7297128B2 (en) * | 2000-08-21 | 2007-11-20 | Gelzone, Inc. | Arm suspension sleeve |
| US7303539B2 (en) * | 2000-08-21 | 2007-12-04 | Binder David M | Gel wrap providing musculo-skeletal support |
| US6963019B2 (en) * | 2000-08-21 | 2005-11-08 | Gelzone, Inc. | Flexible support for gel wraps |
| US6770086B1 (en) | 2000-11-02 | 2004-08-03 | Scimed Life Systems, Inc. | Stent covering formed of porous polytetraflouroethylene |
| DE10114382A1 (en) * | 2001-03-23 | 2002-09-26 | Beiersdorf Ag | Moisture-absorbing material used for plasters, medical fixings, wound coverings and bandages comprises adhesive matrix of silicon, gel former and optionally silicone resin |
| US20030001748A1 (en) * | 2001-04-30 | 2003-01-02 | Dalton Bruce T. | Apparatus and method of determining position by means of a flexible resistive circuit |
| US7026399B2 (en) * | 2002-09-27 | 2006-04-11 | Taylor Made Golf Company, Inc. | Golf ball incorporating a polymer network comprising silicone |
| US7230047B2 (en) | 2003-06-25 | 2007-06-12 | Henkel Corporation | Reformable compositions |
| US8101042B2 (en) | 2003-11-13 | 2012-01-24 | Dow Corning Corporation | Method for adhering silicone gels to plastics |
| US7087135B2 (en) * | 2003-11-14 | 2006-08-08 | Bio Med Sciences, Inc. | Process for the manufacture of interpenetrating polymer network sheeting and useful articles thereof |
| DE602005021767D1 (en) * | 2004-04-08 | 2010-07-22 | Dow Corning | SILICON HAUTKLEBEGELS |
| US9414970B2 (en) * | 2007-10-24 | 2016-08-16 | Bio Med Sciences, Inc. | Wrinkle reducing skin patch, process of manufacture and useful articles thereof |
| EP2313064A2 (en) * | 2008-07-15 | 2011-04-27 | BASF Catalysts LLC | Methods, systems and devices for administration of chlorine dioxide |
| US20100196512A1 (en) | 2009-02-04 | 2010-08-05 | Basf Catalyst Llc | Treatment of Non-Oral Biological Tissue with Chlorine Dioxide |
| US20120135225A1 (en) | 2009-08-18 | 2012-05-31 | Andre Colas | Multi-layer Transdermal Patch |
| WO2011094657A2 (en) | 2010-01-31 | 2011-08-04 | Basf Corporation | Additives for chlorine dioxide-containing compositions |
| EP2371237B1 (en) | 2010-03-31 | 2015-08-26 | MedSkin Solutions Dr. Suwelack AG | Face mask |
| US9226890B1 (en) | 2013-12-10 | 2016-01-05 | Englewood Lab, Llc | Polysilicone base for scar treatment |
| WO2016107897A1 (en) | 2014-12-30 | 2016-07-07 | Mactac Europe Sprl | Multi-layer adhesive tape to compress and contract a scar |
| DE202016104332U1 (en) | 2015-08-12 | 2016-08-17 | Hans Eichinger | Finger film dressing |
| US11174418B2 (en) * | 2016-06-27 | 2021-11-16 | William Marsh Rice University | Fluorine and hydrogen-based adhesive compositions and methods of making the same |
| USD879307S1 (en) | 2018-08-20 | 2020-03-24 | Generation Skin, LLC | Scar therapy patch |
| US20200323694A1 (en) * | 2019-04-09 | 2020-10-15 | Bio Med Sciences, Inc. | Layered apertured wound dressing, process of manufacture and useful articles thereof |
| CN114025748A (en) | 2019-07-09 | 2022-02-08 | 罗曼治疗系统股份公司 | Transdermal therapeutic system comprising an active agent-containing layer comprising a silicone-containing polymer and a skin contact layer comprising a silicone gel adhesive |
| EP3996693A1 (en) | 2019-07-09 | 2022-05-18 | LTS Lohmann Therapie-Systeme AG | Transdermal therapeutic system comprising an active agent-containing layer comprising an acrylic polymer and a skin contact layer comprising a silicone gel adhesive |
| DE202022106557U1 (en) | 2022-11-23 | 2022-12-02 | Elena Berkana | Mesh Face Mask |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4945125A (en) * | 1987-01-05 | 1990-07-31 | Tetratec Corporation | Process of producing a fibrillated semi-interpenetrating polymer network of polytetrafluoroethylene and silicone elastomer and shaped products thereof |
| US5066683A (en) * | 1987-01-05 | 1991-11-19 | Tetratec Corporation | Microporous waterproof and moisture vapor permeable structures, processes of manufacture and useful articles thereof |
| US5157058A (en) * | 1987-01-05 | 1992-10-20 | Tetratec Corporation | Microporous waterproof and moisture vapor permeable structures, processes of manufacture and useful articles thereof |
| US4983395A (en) * | 1987-11-12 | 1991-01-08 | Theratech Inc. | Device for administering an active agent to the skin or mucosa |
| US4832009A (en) * | 1987-12-23 | 1989-05-23 | Bio Med Sciences, Inc. | Semi-interpenetrating network polymer backsheet bandage |
| US5656279A (en) * | 1994-02-23 | 1997-08-12 | Bio Med Sciences, Inc. | Semi-interpenetrating polymer network scar treatment sheeting, process of manufacture and useful articles thereof |
-
1994
- 1994-02-23 US US08/200,152 patent/US5656279A/en not_active Expired - Lifetime
-
1995
- 1995-02-21 AU AU18801/95A patent/AU1880195A/en not_active Abandoned
- 1995-02-23 DK DK95911065T patent/DK0746341T3/en active
- 1995-02-23 EP EP95911065A patent/EP0746341B1/en not_active Expired - Lifetime
- 1995-02-23 DE DE69532990T patent/DE69532990T2/en not_active Expired - Lifetime
- 1995-02-23 JP JP52241395A patent/JP3739394B2/en not_active Expired - Lifetime
- 1995-02-23 WO PCT/US1995/002147 patent/WO1995022997A1/en active IP Right Grant
- 1995-02-23 CA CA002183993A patent/CA2183993A1/en not_active Abandoned
-
1997
- 1997-08-11 US US08/910,304 patent/US5980923A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| EP0746341B1 (en) | 2004-05-06 |
| DE69532990T2 (en) | 2009-09-17 |
| US5980923A (en) | 1999-11-09 |
| WO1995022997A1 (en) | 1995-08-31 |
| DE69532990D1 (en) | 2004-06-09 |
| US5656279A (en) | 1997-08-12 |
| EP0746341A1 (en) | 1996-12-11 |
| EP0746341A4 (en) | 1998-02-25 |
| DK0746341T3 (en) | 2004-09-06 |
| JP3739394B2 (en) | 2006-01-25 |
| AU1880195A (en) | 1995-09-11 |
| JPH10501431A (en) | 1998-02-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |