System for cell growth

Details System for cell growth System for cell growth

1998-10-13

2002-01-22

Buiz, Michael (Department: 3731)

Surgery

Controlled release therapeutic device or system

C435S176000

Reexamination Certificate

active

06340360

ABSTRACT:

BACKGROUND
Field of the Invention
The invention relates to methods and apparatus for control of cell growth, including angiogenesis, in porous implants, produced from ceramics, of the low density type from the general family described in Banas, et al,
Thermophysical and Mechanical Properties of the HTP Family of Rigid Ceramic Insulation Materials,
AIAA 20th Termophysics Conference, Jun. 19-21, 1985, Williamsburg, Va. (incorporated herein by reference), Creedon, et al.,
Strength and Composites,
SAMPE Quarterly, October and (incorporated herein by reference), U.S. Pat. No. 4,148,962, issued to Leiser, et al. on April 1979 (incorporated herein by reference). As an example of the general family, a thermal insulation material is produced by Lockheed Missiles & Space Company, Inc. of Sunnyvale, Calif., having the following properties, according to what is believed to be an Occupational Health and Safety Administration Material Data Sheet of Feb. 28, 1989, as follows:
I. PRODUCT IDENTIFICATION
Trade name (as labeled): HTP (High Thermal Performance) Material Chemical names, common names: Thermal insulation material.
Manufacturer's name: Lockheed Missiles & Space Company, Inc.
Address: 1111 Lockheed Way, Sunnyvale, Calif. 94089
Emergency phone:
(408) 742-7215
Refer questions to:
(6 .a.m.-5 p.m. PST)
Lockheed Missiles & Space
(408) 742-3536
Company, Inc.
(Off Hours)
Occupational Safety &
Business phone:
(408) 742-7215
Health Dept.
Org/4720 - 8/106
Date prepared: 1/89
II. HAZARDOUS INGREDIENT
Exposure Limits in Air
Chemical
Gas
Percent
AGGIH
Names
Numbers
(by vt.)
OSHA (PEL)
(TLV)
Other
Alumina
1344-28-1
10-50
5 mg/m
3
/
10 mg/m
3
Fiber
15 mg/m
3
(Total
(Respirable/
nuisance
Total dust)
dust)
Silica
60676-86-0
50-90
5 mg/m
3
/
10 mg/m
3
See
Fiber
15 mg/m
3
(Fibrous
Health
(Respirable/
Glass)
Effect
Total dust)
Silicon
409-21-2
1-3
5 mg/m
3
/
10 mg/m
3
Carbide
15 mg/m
3
(Total
(Respirable/
nuisance
Total dust)
dust)
Boron
10-043-115
1-5
5 mg/m
3
/
10 mg/m
3
Nitride
15 mg/m
3
(Total
(Respirable/
nuisance
Total dust)
dust)
III. PHYSICAL PROPERTIES
Vapor density (air=1): NA
Specific gravity: Varies
Solubility in water: Nil
Vapor pressure, mmHg at 20 degrees c: NA
Evaporation rate (butyl acetate=1): NA
Appearance and odor: Solid off-white blocks, no odor.
Softening point or range, degrees F: 2876
Boiling point or range, degrees F: NA
IV. FIRE AND EXPLOSION
Flash Point, degrees F: Nonflammable (will not support combustion)
Autoignition temperature, degrees F: NA
Flammable limits in air, volume %: NA
Fire extinguishing materials: NA
Special firefighting procedures: NA
Unusual fire and explosion hazards: NA
V. HEALTH HAZARD INFORMATION
Symptoms of Overexposure
Inhaled: Irritation or soreness in throat and nose. In extreme exposure some congestion may occur.
Contact with skin or eyes: Local irritation, rash.
Swallowed: Not a primary entry route.
Health Effects or Risks from Exposure
Acute: Mechanical irritant to skin, eyes, and upper respiratory system.
Chronic: Results of studies on the effect of silica fiber exposure causing malignant and non-malignant respiratory disease in man are controversial. Studies on laboratory animals fall in to two categories: animals which breathed high concentrations showed no disease, while some exposed through artificial means (e.g., implantation) have developed cancer. Recent U.S. and European studies of almost 27,000 production workers. (1930s to 1980s) found no significant increase in disease from fiber glass exposure. Even though the extensive human studies were judged inadequate for carcinogenicity, IARC has classified glass wool as possibly carcinogenic for humans, based on the artificially exposed animal studies. Fibrous glass is not considered a carcinogen by NTP and OSHA. As a conservative approach in the absence of conclusive knowledge indicating otherwise, we recommend treating this material as if it is a potential carcinogen. Handling procedures such as HEPA vacuum and local exhaust ventilation should be used to minimize exposure. See Special Handling Procedures.
Periodic air monitoring is recommended. The NIOSH recommended exposure limit for fibrous glass is 3 fibers/cc. The manufacturer of the silica fiber used in this product recommends an exposure limit of 1 fiber/cc.
First Aid
Skin: Wash thoroughly with soap and water.
Eyes: Flush thoroughly with water for 15 minutes.
Inhaled: Move person to fresh air at once. If person has stopped breathing, administered artificial respiration. Get immediate medical attention.
Suspected Cancer Agent
No.: This product's ingredients are not found in the lists below.
_X_ Yes:
———
Federal OSHA
———
NTP
_X_ IARC
Medical Conditions Aggravated by Exposure
Pre-existing upper respiratory conditions and lungs diseases may be aggravated.
VI. REACTIVITY DATA
Stability:
_X_ Stable
———
Unstable
Incompatibility (materials to avoid): Will react with hydrofluoric acide.
Hazardous decomposition products: NA
Hazardous polymerization:
———
May occur
_X_ Will not occur
Conditions to avoid: None
VII. SPILL LEAK AND DISPOSAL PROCEDURES
Spill response procedures: Wet down spills to control dust. Material is not considered a hazardous waste under 40 CFR. Dispose of all wastes in accordance with federal, state and local regulations.
VIII. SPECIAL HANDLING INFORMATION
Ventilation and engineering controls: Local exhaust ventilation should be used for grinding or other operations which generate dust. Hood exhaust should be fitted with a filter which will control 99% of fibers less than 1 micron in diameter.
Respiratory protection: For exposures up to 10 f/cc, use a NIOSH-approved twin cartridge air purifying respirator with high efficiency particulate air (HEPA) filters. For exposures up to 50 f/cc, use a NIOSH-approved full-face respirator with HEPA filters. Above these levels, use an air-supplied respirator.
Eye protection: Safety glasses with side shields should be worn if material is ground, cut, or otherwise disturbed using power tools.
Gloves: Any barrier material.
Other clothing and equipment: Wear loose fitting, long sleeved clothing; Wash exposed areas with soap and warm water after handling; Wash work clothes separately from other clothing; rinse water thoroughly.
Other handling and storage requirements: Protect against physical handling damage.
Protective measures during maintenance of contaminated equipment: Wear a respirator as prescribed in the Respiratory Protection section. Wear gloves and coveralls as appropriate to prevent skin contact.
IX. LABELING
Labeling: Fibrous glass-type materials. Treat as a potential carcinogen.
Acute: May cause skin, eye and respiratory tract irritation.
Chronic: Long term inhalation may cause serious respiratory disease. Handle wet and use respiratory protection.
Proper Shipping Name: Not regulated.
Also, a reusable surface insulation (HRSI) is described by a Lockheed Missles & Space Co. Fact Sheet released September, 1988, titled
Thermal Protection System
(incorporated herein by reference)
Cell Growth in Implants
Implants for drug delivery and infection control preferably interact with the organism in which they are implanted, the interaction being through the medium of tissue fluid and by cellular contact with the implant. The extent of angiogenesis and cellular growth within the implant and the distance through which materials from the implant must diffuse through the tissue fluid to reach the organism's circulatory system may have important effects on functioning of the implant. The latter parameter is especially applicable in the case of implants for drug delivery.
Applications for Drug Delivery Implants
Administration of one or more drugs to a patient at predetermined dosage rates is required for effective treatment and/or prevention of several infectious diseases, including, e.g., tuberculosis, malaria and certain sexually-transmitted diseases (STD's). Public health measures adopted to cope with these diseases rely heavily on administration of prophylactic and treatment drugs on an outpatient basis, but the rising incidence and prevalence of infec

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