Device for paracentesis and thoracentesis

• US 5,725,506 A
• Filed: 01/05/1996
• Issued: 03/10/1998
• Est. Priority Date: 01/05/1996
• Status: Expired due to Fees

• Current Assignee: Denver Biomaterials, Inc.
• Original Assignee: Denver Biomaterials, Inc.
• Inventors: Freeman, Shirley K., Vivian, Bonnie B., Skinkle, David
• Primary Examiner(s): Rimell, Sam
• Assistant Examiner(s): Yeh, Luke
• Application Number:
  US08/583,813
• Time in Patent Office: 795 Days
• Field of Search: 604/164, 604/165, 604/167, 604/169, 604/170, 604/247, 604/158, 128/753, 128/754, 128/752, 128/766
• US Class Current: 604/167.01
• 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 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A method and apparatus for removing fluid from the body of a patient, such as in paracentesis and thoracentesis, is provided. Fluid may be withdrawn via a needle assembly including a sharp introducing needle and a retractile blunt needle. The needle assembly may be withdrawn after the introduction of a drainage catheter, and a valve with multiple sealing points prevents body fluids from leaking from the device through the needle space and prevents communication between the atmosphere and the patient through the needle space. A second drainage port may be used after the needle is withdrawn.

Claims

1. An apparatus useful for fluid withdrawal,

a housing, the housing having a distal end and a proximal end and a chamber extending through the housing from the distal end to the proximal end;

a catheter extending from the distal end of the housing;

a needle assembly including at least one needle, the needle assembly removably extending through the housing chamber and the catheter;

a chamber valve that may be opened or closed, the valve being disposed between the needle assembly and the chamber, and the valve having at least two sealing points, so that the valve is open when the needle assembly extends through the chamber and the valve is closed when the needle assembly is withdrawn from the housing, the valve preventing fluid and gaseous communication through the chamber when it is closed;

a handle removably attached to the housing, the handle being connected to the needle assembly so that the needle assembly may be removed from the housing chamber by removing the handle form the housing;

wherein the needle assembly comprises;

an outer needle having a proximal end and a sharp distal end;

an inner needle having a proximal end and a blunt distal end, the inner needle being slidably contained within the outer needle; and

a biasing element engaged with the inner needle and the outer needle so that the distal end of the inner needle projects distal to the distal end of the outer needle when no force is applied to the distal end of the inner needle.

2. The apparatus of claim 1, wherein the housing has a fluid flow port in fluid communication with the housing chamber, the fluid flow port communicating with the chamber distal to the chamber valve.

3. The apparatus of claim 2, wherein the chamber valve includes a spring that applies sealing force to the chamber valve, and the spring applies force along the direction defined by the proximal and distal ends of the housing chamber.

4. The apparatus of claim 3, wherein the chamber valve further comprises:

a first plunger including a plunger head and a stem extending from the plunger head,

a second plunger including a second plunger head and a second stem extending away from the plunger head, the first plunger stem being hollow and being able to receive the second plunger stem; and

a spring interposed between the first and second plunger heads.

5. The apparatus of claim 4, wherein the housing chamber has a recessed section receiving the first and second plungers, the recessed portion being connected to the remainder of the chamber at two ramp sections, the plungers being bounded by the recessed portion of the chamber and the outer needle, so that when the needle assembly is removed from the chamber, the spring will force the plungers to slide away from each other and up the ramp section into the part of the chamber formerly occupied by the needle, so that the plunger heads will seal the chamber.

6. The apparatus of claim 5, wherein the first and second plunger heads are conically shaped and made of elastomeric material.

7. The apparatus of claim 6, further comprising:

an elastomeric gasket disposed within the chamber distal to the ramp sections, so that when the needle assembly is retracted from the handle and the plungers slide away from each other to seal the chamber, one of the plunger heads contacts a portion of the gasket.

8. The apparatus of claim 7, wherein the handle includes a Luer lock in fluid communication with needle assembly.

9. The apparatus of claim 8, wherein the fluid flow port is a Luer lock located distal to the elastomeric gasket.

10. The apparatus of claim 9, further comprising:

a valve proximate the fluid flow port that prevents fluid and gas flow through the port when the valve is closed and allows fluid flow through the port when the valve is open.

11. The apparatus of claim 10, wherein the valve proximate the fluid flow port is an elastomeric slit disk sealing washer.

12. The apparatus of claim 11, further comprising:

an indicator that indicates the position of the inner needle with respect to the outer needle, the indicator being attached to the inner needle and at least part of the indicator extending distal to the outer needle.

13. The apparatus of claim 12, wherein the handle may attach to the housing in a locked position, and the handle may not be withdrawn from the housing when the handle is in the locked position.

14. The apparatus of claim 13, wherein the handle is locked into the housing by a protrusion on the housing that may be fitted into a slot on the handle.

15. The apparatus of claim 13, wherein the handle is locked into the housing by a protrusion on the handle that may be fitted into a slot on the housing.

16. A method for fluid withdrawal, comprising:

(a) inserting the distal end of a fluid withdrawal apparatus into a body of fluid, the fluid withdrawal apparatus including a housing with a chamber extending therethrough, a catheter extending distal to the housing, a handle attached to the proximal end of the housing, and a needle extending from beyond the distal end of the catheter through the catheter and housing, and attaching to the handle;

(b) withdrawing fluid through the needle;

(c) removing the needle from the housing by detaching the handle from the housing;

(d) sealing the proximal end of the housing so as to prevent fluid and gaseous communication therethrough, the sealing being accomplished at least two sealing points.

17. The method of claim 16, wherein step (d) is accomplished automatically after completion of step (c).

18. The method of claim 17, further comprising the steps of:

(e) attaching a fluid removal container to a fluid removal port in the housing; and

(f) withdrawing fluid through the catheter and into the fluid removal container.

19. The method of claim 18, wherein step (e) is performed after step (c).