SECUREMENT SYSTEM EMPLOYING POLYMERIC GEL

• US 20090137962A1
• Filed: 07/16/2008
• Published: 05/28/2009
• Est. Priority Date: 07/16/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: White, Larry, Nishtala, Vasu, Young, Robert, Bracken, Ronald L.
• Granted Patent: US 8,834,425 B2
• Time in Patent Office: Days
• US Class Current: 604/179
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/20 Elemental chlorine; Inorganic compounds releasing chlorine
• CPC Class Codes: A61K 33/40 Peroxides
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/0089 containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

A gel pad for use with a retainer for securing a medical article. The gel pad is formed from a soft, tacky elastomer. A first surface of the gel pad is placed in contact with a patient'"'"'s skin. A second surface that faces in an opposite direction away from the first surface receives the retainer. The retainer has a channel configured to retain at least a portion of the medical article. In some embodiments, a securement member is employed to affix the retainer relative to the patient. A securement system including the gel pad and retainer is further disclosed along with a method of securing a medical article to a patient.

Claims

1. A securement system for use with a medical article, comprising:

a gel pad for placing upon the skin of a patient; and

a retainer supported at least in part by the gel pad.

2. The securement system of claim 1, wherein the retainer includes a body member configured to retain at least a portion of the medical article within the body member so as to inhibit movement of the secured portion of the medical article relative to the retainer in at least one direction.

3. The securement system of claim 2, wherein the body member includes a longitudinal channel formed through the body member, the channel receiving the secured portion of the medical article.

4. The securement system of claim 3, wherein said retained portion extends entirely through said channel, said channel having a longitudinal access opening disposed on an underside of said body member to allow at least ingress of at least said retained portion of said medical article into the channel.

5. The securement system of claim 3 further comprising at least one abutment extending generally normal to a central axis of said channel and configured to inhibit longitudinal movement of the medical article relative to the retainer.

6. The securement system of claim 1, wherein the gel pad comprises a soft, tacky elastomer.

7. The securement system of claim 1, wherein the gel pad and the retainer form a unitary structure.

8. The securement system of claim 1, wherein the gel pad is formed by curing an organopolysiloxane composition.

9. The securement system of claim 8, wherein the organopolysiloxane composition comprises:

a vinyl-containing high viscosity organopolysiloxane or a blend of high viscosity vinyl-containing organopolysiloxanes;

a low viscosity organopolysiloxane or a blend of low viscosity organopolysiloxanes;

a reinforcing filler;

a platinum catalyst; and

a hydrogen containing polysiloxane copolymer.

10. The securement system of claim 9, wherein a molar ratio of hydrogen to vinyl radicals in the total composition is less than 1.2, such that after curing, the degree to which said tacky, reinforced polysiloxane elastomer is partially crosslinked is about 30 to about 90%.

11. The securement system of claim 8, wherein the organopolysiloxane composition has a hardness of about 5 to about 55 durometer units (Shore 00), a tackiness of about 0 to about 450 grams as determined by a polyken probe tack tester or about 0 to about 7.6 cm (about 0 to about 3 inches) as determined by a rolling ball tack tester and a tensile strength of about 0.14 to about 5.52 mega Pascals (about 20 to about 800 pounds/square inch), a minimum elongation of about 250 to about 1100 percent and a tear strength of about 0.8 to about 35.2 kN/m (about 5 to about 200 pound/square inch).

12. The securement system of claim 8, wherein the organopolysiloxane composition comprises, based upon 100 parts total composition:

to 90 parts of a vinyl-containing high viscosity organopolysiloxane or a blend of high viscosity vinyl-containing organopolysiloxanes having no more than 25 mole percent of phenyl radicals and having a viscosity of 2,000 to 1,000,000 centipoise at 25°

C. of the formula;

where R¹ is selected from the class consisting of alkenyl, alkyl and aryl radicals and R is a monovalent hydrocarbon radical, R² is selected from the class consisting of alkyl and aryl radicals, R⁴ and R⁵ are independently selected from the class consisting of alkyl and vinyl radicals;

x varies from zero to 3000; and

y varies from 0 to 300;

from 5 to 40 parts of a polymer selected from the class consisting of a low viscosity organopolysiloxane and a blend of low viscosity organopolysiloxanes having viscosity that varies from 20 to 5,000 centipoise at 25°

C. and having no more than 25 mole percent phenyl radicals of the formula

wherein R¹ and R⁶ are independently selected from the class consisting of alkenyl, alkyl and aryl radicals, R² and R are as previously defined, R³ is selected from the class consisting of alkyl, aryl and alkenyl radicals, w varies from 0 to 500, and z varies from 0 to 200;

from 10 to 70 parts of a reinforcing filler;

from 0.1 to 50 parts per million of platinum catalyst (as platinum metal) to the total composition; and

from 0.1 to 50 parts of a hydrogen containing polysiloxane copolymer, wherein the molar ratio of hydrogen to alkenyl radicals in the total uncured composition is less than 1.2, such that after curing, the degree to which the soft, tacky, reinforced polysiloxane elastomer is partially crosslinked is about 30 to about 90%.

13. The securement system of claim 1 further comprising a securement member, the securement member being configured to secure the retainer relative to said patient.

14. The securement system of claim 13, wherein the securement member is releasably attachable to the patient.

15. The securement system of claim 13, wherein at least a portion of the securement member is attached to the retainer.

16. The securement system of claim 13, wherein the securement member wraps over at least a portion of the gel pad.

17. The securement system of claim 13 further comprising a pair of mounting wings and a body member, at least a portion of the mounting wings being disposed between the body member and the gel pad at least when the retainer is secured to the patient.

18. The securement system of claim 17, wherein the securement member comprises a pair of straps, each strap being affixed to one of the pair of mounting wings.

19. The securement system of claim 18, wherein at least a portion of each strap is formed from Velcro®

material.

20. The securement system of claim 1 further comprising a mounting surface, at least a portion of the mounting surface being covered with an adhesive.

21. The securement system of claim 20, wherein the mounting surface is disposed on the gel pad.

22. The securement system of claim 20, wherein the mounting surface is disposed on the retainer.

23. The securement system of claim 1, wherein the retainer extends in a direction away from the patient'"'"'s body.

24. A method of securing a medical article to a patient, comprising:

providing a gel pad;

affixing a medical article to a retainer having a body member, the body member having a longitudinal channel formed through the body member, the channel being configured to retain at least a portion of the medical article within the body member; and

locating the retainer relative to the patient so that at least a portion of the gel pad is disposed between at least a portion of the retainer and the patient.

25. The method of claim 24, wherein the gel pad comprises an elastomer.

26. The method of claim 24 further comprising securing the retainer to the patient.

27. The method of claim 24 further comprising adhering the retainer to the gel pad.

28. The method of claim 24, wherein the gel pad is formed by curing an organopolysiloxane composition.

29. A cured organopolysiloxane composition for use with a securement device that secures a medical article to a patient, comprising:

a vinyl-containing high viscosity organopolysiloxane;

a low viscosity organopolysiloxane;

a reinforcing filler;

a platinum catalyst; and

a hydrogen containing polysiloxane copolymer.