Composition I-II and products and uses thereof

Patent metadata

Field	Value
Publication number	US-11730876-B2
Application number	US-201916705056-A
Country	US
Kind code	B2
Filing date	Dec 5, 2019
Priority date	Nov 25, 2010
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

Abstract

A curable composition apportioned between at least one Part A and at least one Part B, the Parts sealed within barrier means preventing contamination, the at least one Part A comprising:(i) one or more alkenyl-group containing prepolymers having at least one alkenyl group or moiety per molecule,and the at least one Part B comprising:(ii) one or more SiH-containing prepolymers having at least one Si—H unit per molecule;the composition additionally comprising:(iii) a catalyst for curing by addition of alkenyl-containing prepolymer (i) to SiH-containing prepolymer (ii),wherein prepolymer (ii) is substantially absent from Part A and prepolymer (i) is substantially absent from Part B,methods for preparing the composition, methods for sterilisation thereof, medical and non-medical use thereof, a device incorporating the composition, and a precursor therefor including its sterilisable precursor composition, in particular a terminally sterilisable or terminally sterile composition for medical use, particularly in wound therapy, more particularly as a wound packing material which can be shaped and configured to the shape of a wound, most particularly for application in negative pressure wound therapy (NPWT).

First claim

The invention claimed is:

1. A curable composition apportioned between at least one Part A and at least one Part B, the composition comprising:
the at least one Part A comprising one or more alkenyl-group containing polymers having at least one, or at least two, alkenyl group or moiety per molecule,
the at least one Part B comprising one or more SiH-containing polymers having at least one, or at least two, Si—H unit or moiety per molecule,
a catalyst for curing by addition of an alkenyl-containing polymer to a SiH-containing polymer, and
a blowing agent configured to evolve gas as part of or during the curing reaction,
wherein the SiH-containing polymer is absent from Part A and the alkenyl-group containing polymer is absent from Part B or Part B incorporates a trace amount of the alkenyl-group containing polymer represented as a molar ratio (Si—H unit or moiety)/(alkenyl unit or moiety) of greater than or equal to 2000.

2. A method of preparing a composition as claimed in claim 1 , comprising combining the one or more alkenyl-group containing polymers, the one or more SiH-containing polymers, the catalyst, and the blowing agent to form the at the least one Part A and the at least one Part B.

3. A method of sterilizing a composition as claimed in claim 1 , comprising irradiating the composition Parts in a sterilizing dose or irradiating the at least one of Part A and the at least one Part B and sterilizing other one or more Parts by alternative means.

4. A method of preparing an elastomer comprising combining the at least one Part A and the at least one Part B of the composition as claimed in claim 1 with curing or crosslinking thereof.

5. An elastomer comprising the cured or crosslinked composition of claim 1 .

6. An elastomer as claimed in claim 5 , wherein the elastomer comprises a porous foam, adhesive, or sealant.

7. An elastomer as claimed in claim 5 , wherein the elastomer comprises a foamed cured wound filler, wound packing material, cavity foam dressing.

8. A composition dispensing device comprising a composition as claimed in claim 1 .

9. A device as claimed in claim 8 , further comprising a mixing head configured to receive two or more cartridges comprising Parts A and B.

10. A method for treating a wound site using a composition as claimed in claim 1 , the method comprising:
dispensing a terminally sterile foamable composition into at least a portion of the wound site, wherein the foamable composition forms a porous foam material configured to transmit negative pressure;
covering the wound site with a fluid-tight drape, the drape covering at least a portion of the dispensed terminally sterile composition;
forming a fluid-tight seal over the wound site; and
applying negative pressure to the wound site from a source of negative pressure.

11. The method of claim 10 , further comprising connecting the source of negative pressure by connecting a conduit to the wound site through or under the fluid-tight seal.

12. A NPWT kit comprising a fluid-tight wound dressing, a dispensible or releasable terminally sterile adhesive or sealant composition as claimed in claim 1 , and an attachment for a vacuum pump to supply negative pressure to the dressing.

13. A device for dispensing the composition as claimed in claim 1 , the device comprising a mixing head configured to receive two or more cartridges comprising Parts A and B.

14. A device of claim 13 , the device comprising a double barreled syringe configured for loading with 40 g of the polymers.

15. A method for treating a wound site using a composition as claimed in claim 1 , the method comprising:
dispensing a terminally sterile composition around at least a portion of the wound site, wherein the composition comprises a first part and a second part that when combined form a material configured to make a fluid-tight seal;
covering the wound site with a fluid-tight drape, the drape covering at least a portion of the dispensed terminally sterile composition;
forming a fluid-tight seal over the wound site; and
applying negative pressure to the wound site from a source of negative pressure.

16. The method of claim 15 , further comprising mixing the first and second parts of the terminally sterile foamable composition while dispensing the composition.

17. A method for treating a wound site using a composition as claimed in claim 1 , the method comprising:
applying a dressing to the wound site;
releasing a first part of a terminally sterile composition from a support about or around at least a portion of the wound site and exposing the first part;
exposing a second part of the terminally sterile composition supported on a fluid-tight drape;
covering the wound site with the drape, thereby contacting and adhering the exposed first and second parts and adhering the drape about or around the wound site;
forming a fluid-tight seal over the wound site; and
applying negative pressure to the wound site from a source of negative pressure.

Assignees

• Smith & Nephew
• Bluestar Silicones France

Inventors

• Phillips Marcus Damian
• Blanc Delphine

Classifications

• A61F13/05

  specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT] · CPC title

• A61M1/915 Primary

  Constructional details of the pressure distribution manifold · CPC title

• A61F13/0216

  Human Necessities · mapped topic

• A61L15/26

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof {(A61L15/225 takes precedence)} · CPC title

• A61L15/425

  Porous materials, e.g. foams or sponges · CPC title