Pneumothorax medical treatment device

• US 9,919,082 B2
• Filed: 07/09/2014
• Issued: 03/20/2018
• 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
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US14/326,711
• Publication Number:
  US 20160008524A1
• Time in Patent Office: 1,350 Days
• 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 including an outlet, an interior chamber in fluid communication with the outlet and a needle mount in an end of the housing opposite to the outlet,

a hollow needle including a proximal end and a distal end, the proximal end is seated in and secured to the needle mount of said housing, wherein the hollow needle extends from the housing to the distal end, the distal end is configured to penetrate a chest wall of the human patient and an exposed outer surface of the hollow needle is visible while the hollow needle is inserted into the chest wall,

a hollow stylet permanently within and coaxial to the hollow needle, wherein the hollow stylet includes a proximal end extending into the interior chamber, a distal portion having a closed end, and an internal passage within the hollow stylet extending from the distal portion to an outlet at the proximal end of the hollow stylet,

wherein the hollow stylet is slidably received in said hollow needle such that an outer surface of the hollow stylet slides against an inner surface of the hollow needle, and the hollow stylet slides between an extended position at which the closed end of the hollow stylet extends beyond the distal end of said hollow needle, and a retracted position at which the closed end of the hollow stylet is retracted within the hollow needle,

said hollow stylet including at least one aperture in the distal portion and forming an inlet to the internal passage within the hollow stylet,

a spring configured to bias said hollow stylet towards said extended position, wherein the spring is within the interior chamber of the housing, between the proximal end of the hollow stylet and the outlet to the housing, and does not overlap with the stylet, and

a spring support fixed to the proximal end of the stylet and including a passage with an inlet aligned with the proximal end of the stylet and an outlet at an end of the spring in the interior chamber of the housing, wherein the spring support overlaps with the spring and the stylet.

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 a visual indicator, connected to said stylet, configured to provide a visual indication at said housing indicating when the stylet is in the retracted state, wherein the visual indicator is fixed to the proximal end of the hollow stylet and supporting an end of the spring.

4. The medical device of claim 1, further comprising a one-way valve within the interior chamber of the housing and between the spring and the outlet to the housing, wherein the one-way valve permits gas to flow only from the proximal end of the hollow stylet, through the interior chamber of the housing and towards the outlet.

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

6. The medical device of claim 1, wherein the outer surface of said hollow stylet and the inner surface of said hollow needle are configured to slide against one another while the hollow stylet moves between the retracted and extended positions.

7. The medical device of claim 1, wherein said the at least one aperture in the distal portion of the hollow stylet comprises at least two apertures fluidly connected to the passage in the hollow stylet.

8. The medical device of claim 1, wherein the outer surface of said hollow needle is graduated or marked off in regular intervals from the housing to the distal end of the hollow needle.

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

10. The medical device of claim 1, wherein said medical device is comprised of parts configured to resist temperatures of sterilization.

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

12. The medical device of claim 1, wherein an outer diameter of the hollow needle is configured to conform to a size defined by 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 hollow stylet are comprised of stainless steel,

wherein the outer surface of said hollow stylet and the inner surface of said hollow needle are configured to slide against one another while the hollow stylet moves between the retracted and extended position, and

a visual indicator connected and fixed to said hollow stylet, supporting an end of the spring, and providing a visual indication at said housing indicating when the hollow stylet is in the retracted state.

15. The medical device of claim 1, wherein the spring support includes a stem extending away from the proximal end of the hollow stylet and extend into the spring.

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

a housing with an outlet, a mount, and an interior chamber between the outlet and the mount;

a hollow needle including a proximal end secured to the mount of the housing, and a shaft extending from said housing to a distal end, wherein the shaft has an exposed outer surface,

a hollow stylet including an open proximal end, a closed distal end and an interior passage extending from an opening adjacent the closed distal end to the open proximal end that is open to the interior chamber of the housing; and

said hollow stylet is slidably received in said hollow needle such that an outer surface of the hollow stylet slides against an inner surface of the hollow needle as the hollow stylet moves between an extended position at which the closed distal end of said hollow stylet extends beyond the distal end of said hollow needle, and a retracted position at which the closed distal end of said stylet is retracted within said hollow needle;

a spring configured to bias said hollow stylet towards said extended position, wherein the spring is within the interior chamber of the housing, between the proximal end of the hollow stylet and the outlet to the housing and does not overlap the hollow stylet; and

a spring support fixed to the proximal end of the stylet and including a passage with an inlet aligned with the proximal end of the stylet and an outlet at an end of the spring in the interior chamber of the housing, wherein the spring support overlaps with the spring and the stylet,

said method comprising;

while grasping the housing, 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,

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

monitoring a depth of the insertion of the hollow needle into the chest by visually inspecting the outer surface of the hollow needle.

17. The method of claim 16 further comprising applying a vacuum to said housing outlet.