PNEUMOTHORAX MEDICAL TREATMENT DEVICE

• US 20160008524A1
• Filed: 07/09/2014
• Published: 01/14/2016
• Est. Priority Date: 07/09/2014
• Status: Active Grant

• Current Assignee: Safeguard Medical Holdco, LLC
• Original Assignee: H&H Medical Corporation
• Inventors: HARDER, Paul, COAKLEY, Timothy, TYLER, James, SWEATMAN, Mark
• Granted Patent: US 9,919,082 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2210/101 Pleural cavity

Abstract

The invention provides for an improved medical device used to remove gas and liquid from the plural cavity between the lung and the chest wall in both stationary and mobile applications. The present invention generally comprises a hollow needle with a hollow closed end stylet slidably received in the needle. The stylet is spring-biased to extend out of the needle end as a safety tip but when pressured is moved to a retracted position to allow for insertion through the chest wall. The pressure needed to insert the needle/stylet combination through the chest wall is applied by a housing at the end of the needle which is contoured for easy grip. While not being applied to the chest wall, the stylet comprises a safety tip, which makes the device safe to handle and apply in stationary or mobile applications. Further, the housing includes a one-way valve is configured permit only the passage of air and bodily fluid out of the pleural cavity without a secondary structure needed. The present invention is useful in safely and effectively treating a variety of related conditions including pneumothorax (collapsed lung), tension pneumothorax (collapsed lung pressing on the heart), and pneumohemothorax (collapsed lung with air and bodily fluids in the pleural cavity).

Claims

1. A medical device for treating tension pneumothorax in a human patient, said device comprising:

a housing with an outlet;

a hollow needle with one end secured to said housing opposite said outlet and the other end extending from said housing,

a stylet having a hollow inner passage, said stylet slidably received in said needle and moveable between an extended position, in which a closed end of said stylet extends beyond the end of said needle, and a retracted position, in which the closed end of said stylet does not extend beyond said needle, said stylet including at least one aperture adjacent said closed end of the stylet and fluidly connected to the hollow inner passage;

a spring configured to bias said stylet towards said extended position; and

a one-way valve, located in said housing, and fluidly connected to said stylet aperture, said valve configured to only permit gas flow into the stylet through the aperture and out of said outlet.

2. The medical device of claim 1, wherein said housing is shaped to provide a gripping surface, said gripping surface of said housing configured to permit an operator to exert a force on said needle sufficient to penetrate a chest wall of said human patient.

3. The medical device of claim 1, further comprising visual indicator means, connected to said stylet, for providing a visual indication at said housing for indicating when the stylet is in the retracted state. b

4. The medical device of claim 1, further comprising means for fluidly connecting said one-way valve to any fluid fitting.

5. The medical device of claim 1, wherein said hollow needle and said stylet are comprised of stainless steel.

6. The medical device of claim 1, wherein the outside surface of said stylet and the inside surface of said hollow needle are configured to slide against one another when moving from the retracted and extended position.

7. The medical device of claim 1, wherein said stylet comprises two apertures adjacent said closed end of the stylet fluidly connected to the hollow inner passage

8. The medical device of claim 1, wherein the outer surface of said hollow needle is graduated or marked off in intervals.

9. The medical device of claim 1, further comprising a container, sterilized and vacuum sealed after said medical device is placed inside.

10. The medical device of claim 1, wherein said medical device is comprised of parts capable of resisting temperatures of sterilization.

11. The medical device of claim 1, wherein said housing is transparent.

12. The medical device of claim 1, wherein the outer diameter of the hollow needle is configured in sizes according to the Birmingham Wire Gauge.

13. The medical device of claim 1, wherein said housing is configured to rest upon the chest wall of the patient, to more easily secure said device to said patient.

14. The medical device of claim 1, wherein said housing is shaped to provide a gripping surface,

wherein said hollow needle and said stylet are comprised of stainless steel,

wherein the outside surface of said stylet and the inside surface of said hollow needle are configured to slide against one another when moving from the retracted and extended position.

further comprising means for fluidly connecting said one-way valve to any fluid fitting, and

comprising visual indicator means, connected to said stylet, for providing a visual indication at said housing for indicating when the fluid transfer mean is in the retracted state

15. A method for treating a tension pneumothorax in a human patient with a medical device comprising:

a housing with an outlet;

a hollow needle with one end secured to said housing opposite said outlet and the other end extending from said housing,

a stylet having a hollow inner passage, said stylet slidably received in said needle and moveable between an extended position, in which a closed end of said stylet extends beyond the end of said needle, and a retracted position, in which the closed end of said stylet does not extend beyond said needle, said stylet including at least one aperture adjacent said closed end of the stylet and fluidly connected to the hollow inner passage;

a spring configured to bias said stylet towards said extended position; and

a one-way valve, located in said housing, and fluidly connected to said stylet aperture, said valve configured to only permit gas flow into the stylet through the aperture and out of said outlet,

said method comprising;

applying a downward pressure to the closed end of said stylet to temporarily overcome said spring bias and move said stylet into said retracted position, and

continuing said application of pressure as said extended end of said hollow needle passes through the chest wall continuing only until said extended end enters the pleural cavity of said patient,

wherein gas flow is only permitted into the stylet through the aperture and out of said housing outlet

16. The method of claim 18 further comprising applying an atmospheric vacuum to said housing outlet.

17. A medical device for treating tension pneumothorax in a human patient, said device comprising:

a housing with an outlet;

a hollow needle with one end secured to said housing opposite said outlet and the other end extending from said housing,

a fluid transfer means for fluidly connecting the two ends of said hollow needle, said fluid transfer means slidably received in said needle and moveable between an extended position, in which a closed end of said fluid transfer means extends beyond the end of said needle, and a retracted position, in which the closed end of said fluid transfer means does not extend beyond said end of said needle (or needle end), and including at least one aperture adjacent to said closed end.

a means for biasing said fluid transfer means towards said extended position; and

a one-way valve means for fluidly connecting said fluid transfer means to said housing outlet for regulating air flow to only permit gas flow into the fluid transfer means through the aperture and out of said housing outlet.