Gaseous nitric oxide-sequestering products and processes of preparing same

Abstract

A process of preparing articles having gaseous NO sequestered therein is disclosed, as well as articles prepared thereby. Also disclosed are articles having gaseous NO sequestered therewithin and having reduced amount of oxygen-containing and/or nitrogen-containing reactive species. Also disclosed are processes of preparing packaged articles having a non-gas permeable package that comprises gaseous NO therein and packaged articles made therefrom. Also disclosed are charging devices which can be utilized in the above-described processes. The articles prepared by the above-described processes are preferably medical devices such as indwelling catheters, intubation devices and tampons. Tampons having sequestered therein gaseous NO, uses thereof and processes of preparing same are also disclosed.

Description

FIELD AND BACKGROUND OF THE INVENTION[0001]The present invention, in some embodiments thereof, relates to medical products and, more particularly, but not exclusively, to products having gaseous nitric oxide (NO) sequestered therein, to processes and systems for producing such products and to uses thereof.[0002]Infection is a constant risk to any healthy person, and poses even a higher risk to hospitalized patients. Infections which are a result of treatment in a hospital or a healthcare service unit are often termed nosocomial infections. The risk of infection is further increased when the natural infection barriers of skin or other epithelial surfaces are breached during a surgical procedure, and / or otherwise in cases where bacteria normally present on the skin or in the air is allowed to access the interior surfaces of the body.[0003]Nosocomial infections occur even when good hygiene and sterile technique is followed, although the incidence is reduced. Despite even the most rigor...

AI Technical Summary

Benefits of technology

[0108]According to some embodiments of the invention, the process further comprises, prior to the filling, reducing a pressure in the chamber.

Problems solved by technology

Infection is a constant risk to any healthy person, and poses even a higher risk to hospitalized patients.

The risk of infection is further increased when the natural infection barriers of skin or other epithelial surfaces are breached during a surgical procedure, and / or otherwise in cases where bacteria normally present on the skin or in the air is allowed to access the interior surfaces of the body.

While medical devices that comprise metal, glass or other heat-stable materials can be treated with steam (autoclave) or hot air, the use of various polymers and plastics in medical devices may render heat-dependent sterilization unsuitable.

However, regardless of the method of sterilization, the medical device is only sterile until it is exposed to a non-sterile environment.

Contamination may even occur in a surgical environment.

CAB carries with it a 2.8-fold increased risk of death and results in bacteremia in approximately 3% of patients, constituting a serious complication.

CAB is difficult to treat with current antimicrobial strategies because of the antibiotic resistance biofilm that forms from free-floating bacteria that adhere to the surface of catheters and colonize them.

Catheterization also disrupts the uroepithelial mucosa, exposing new binding sites for bacterial adhesins.

However, silver oxide catheters were not associated with a statistically significant reduction in CAB, and other meta-analyses have similarly concluded that silver oxide coated catheters are ineffective.

However, nitrofurans have been demonstrated to be ineffective against most strains of Pseudomonas aeruginosa, and they do not inhibit viruses or fungi.

Nitrofurazone catheters are also very expensive.

However, orally-administered azoles such as fluconazole may be associated with side effects, such as GI intolerance and headache, and sometimes rash and liver toxicity [Nyirjesy, 2008, supra].

However, women with chronic or persistent yeast infections (RVVC) are less likely to respond to shorter treatment regimens, and symptomatic relapse occurs in more than half of RVCC cases within a short time of treatment cessation.

Multiple-day treatment regimens are more effective in women prone to RVVC and in certain populations, but the inconvenience of these regimens may negatively impact treatment compliance and satisfaction, symptom control, and quality of life.

Furthermore, single-dose oral or intravaginal therapy is limited in its efficacy to the treatment of mild to moderate infections.

Oral azoles are also contraindicated during pregnancy, are ineffective in vaginitis caused by C. glabrata, and may be associated with side effects such as GI intolerance, headache, and more rarely, rash and liver toxicity.

High rates of recurrence and lack of symptom resolution indicate that the primary treatment of BV with antibiotics may not be completely effective.

In addition, antibiotic resistance becomes a potential issue facing continued antibiotic treatment of BV, as well as possible changes to the composition of the normal flora of the vagina.

Forty-two percent of women with recurrent vaginal infections have been reported to resort to alternative therapies, such as probiotics or homeopathy, dietary restriction of sugars and inclusion of yogurt, and hormonal manipulation with depot medroxyprogesterone and desensitization therapy, to prevent recurrences, yet, support for the efficacy of these methodologies are sparse and often lack methodological quality and / or sufficient data.

However, nitric oxide is rather complicated for use as a gas.

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