Apparatus for intraosseous infusion or aspiration

• US 5,817,052 A
• Filed: 12/26/1995
• Issued: 10/06/1998
• Est. Priority Date: 12/26/1995
• Status: Expired due to Term

• Current Assignee: PYNG Medical Corporation (Teleflex Incorporated)
• Original Assignee: PYNG Medical Corporation (Teleflex Incorporated)
• Inventors: Findlay, Judith M., Higgs, David, McMorran, William Eric, Johnson, David L., Jacobs, Michael W.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/578,042
• Time in Patent Office: 1,015 Days
• Field of Search: 604/51, 604/49, 604/27, 604/28, 604/264, 604/19, 604/21, 128/751, 128/753, 128/754
• US Class Current: 604/506
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/1691 for the sternum
• 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 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

An apparatus comprising three main assemblies, an applicator, an infusion/aspiration tube with a subcutaneous bone penetration means, and a strain relief protector. The apparatus enables a user in field or emergency environments to quickly, safely and reliably place an infusion/aspiration device in a patient'"'"'s bone, regardless of the thickness of skin and tissue over the bone, and to ensure it will remain in place throughout other emergency procedures and severe environmental conditions. The infusion/aspiration apparatus incorporates a bone stop to ensure precise location of the bone penetration means at the intended marrow depth in the patient'"'"'s bone. A method of intraosseous infusion or aspiration has a first step of locating the appropriate site on a suitable bone, a second step of inserting a bone penetration means device through the skin using an applicator, a third step of placing a fluid delivery port at a precise depth by mechanical location means which use the surface of the target bone as a reference point, a fourth step of removing the applicator, an optional fifth step of installing a strain relief protector, and a final step of attaching a source of fluids for infusion or of suction for aspiration.

Claims

1. A bone-installed apparatus for intraosseous fluid infusion or aspiration of bone marrow of a patient, comprising a fluid conduit having a distal end and a proximal end, the distal end of the fluid conduit being movable relative to the proximal end, the proximal end adapted to be installed in the bone of the patient.

2. An apparatus as claimed in claim 1 including a bone penetration means with a proximal end, and a distal end connected to the fluid conduit.

3. An apparatus as claimed in claim 1 wherein a proximal part of the fluid conduit is a bone penetration means and the bone penetration means has a lumen fluid transmission means therein extending from a proximal end to a distal end.

4. An apparatus as claimed in claim 3 wherein a part of the fluid conduit is a flexible tubing which is connected to the distal end of the lumen fluid transmission means of the bone penetration means.

5. An apparatus as claimed in claim 2 including an applicator means which detachably engages the bone penetration means and enables an administrator to cause the proximal end of the bone penetration means to penetrate part of a bone and part of underlying bone marrow of the patient.

6. An apparatus as claimed in claim 3 wherein the bone penetration means has a port in its proximal end connected to the lumen.

7. An apparatus as claimed in claim 2 wherein the proximal end of the bone penetration means is sharp.

8. An apparatus as claimed in claim 5 wherein a part of the fluid conduit is a flexible tubing.

9. An apparatus as claimed in claim 2 wherein the bone penetration means has a low profile and when installed subcutaneously in the patient, the distal end of the bone penetration means does not protrude above the skin of the patient.

10. An apparatus as claimed in claim 5 wherein the applicator means is a handle and an associated rigid stylet, which penetrates the interior of the fluid conduit, contacts the bone penetration means, and enables an administrator to cause the proximal end of the bone penetration means to penetrate through surface bone and into the underlying bone marrow of the patient.

11. An apparatus as claimed in claim 2 wherein the length of the fluid conduit is sufficient to permit a surplus of fluid conduit between the proximal end and the distal end so that the distal end of the fluid conduit can be moved without disturbing a proximal end of the fluid conduit which is connected to the distal end of the bone penetration means.

12. A bone-installed apparatus for intraosseous fluid infusion or aspiration of bone marrow of a patient, comprising:

(a) a fluid conduit having a distal end and a proximal end; and

(b a bone stop means, a proximal side of the bone stop means adapted to impinge against a surface of the bone when the proximal end of the fluid conduit is located in underlying bone marrow.

13. An apparatus as claimed in claim 12 including a bone penetration means with a proximal end and a distal end connected to the fluid conduit.

14. An apparatus as claimed in claim 13 including an applicator means which detachably engages the bone penetration means and enables an administrator to cause the proximal end of the bone penetration means to penetrate part of a bone and part of underlying bone marrow of the patient.

15. An apparatus as claimed in claim 14 wherein the bone stop means is located on a proximal end of the applicator means.

16. An apparatus as claimed in claim 14 wherein the bone stop means comprises a plurality of rods which protrude from a proximal end of the applicator means.

17. An apparatus as claimed in claim 16 wherein the rods encircle at least part of the distal end of the bone penetration means.

18. An apparatus as claimed in claim 14 wherein the applicator means is hollow, elongated and open at one end, a stylet having a distal end and a proximal end is located longitudinally within the hollow of the applicator means, the proximal end of the stylet protruding from the hollow through the open end, and the bone stop means is located on a proximal end of the applicator means adjacent to the open end.

19. An apparatus as claimed in claim 18 wherein the applicator means is bifurcated and open on each side to provide a first proximal part and a second proximal part, the stylet being accessible through the openings on each side between the first proximal part and the second proximal part, and from the open end of the hollow applicator means, the bone stop means comprising a pair of clusters of longitudinally extending rods, the first of the pair of rod clusters being located at the proximal end of the first proximal part and the second of the pair of rod clusters being located at the proximal end of the second proximal part.

20. An apparatus as claimed in claim 19 wherein proximal tips of the first proximal part and proximal tips of the second proximal part can be moved together to support lateral sides of the stylet.

21. An apparatus as claimed in claim 15 including a protective covering which removably fits over the bone stop means.

22. An apparatus as claimed in claim 16 including a sliding stop means which slidably fits on the plurality of rods, the sliding stop means having sharp, hollow proximal points which correspond in number and location with the number of rods, the hollow proximal points enabling the respective plurality of rods to slide through the corresponding hollow proximal points.

23. A low profile bone penetration apparatus for subcutaneous intraosseous fluid infusion into or aspiration of bone marrow of a patient comprising:

(a) a sharp proximal end for penetrating surface bone and a portion of underlying bone marrow of the patient;

(b) at least one port located on a side of the apparatus adjacent to the sharp proximal end;

(c) a surface for impinging against a bearing surface of a detachable applicator; and

(d) a hollow distal end connected internally with the port by a lumen which enables a fluid conveyance means to be detachably connected to the hollow distal end, the length between the hollow distal end and a reference point distal to the proximal end being less than the depth of tissue and skin overlying the bone of the patient so that the bone penetration apparatus adapted to impinge subcutaneously in the patient.

24. An apparatus as claimed in claim 23 wherein the port is located at the proximal end and connects with the lumen.

25. An apparatus as claimed in claim 23 wherein a plurality of ports is located in the sides of the penetration apparatus adjacent to the sharp proximal end and at a distance from the proximal end which is adjacent to bone marrow when the bone penetration apparatus resides subcutaneously in the patient, said side ports connecting with the lumen.

26. An apparatus comprising:

(a) a bone penetration means with a proximal end and a distal end and lumen fluid transmission means therein extending from the proximal end to the distal end;

(b) an applicator means which detachably engages the bone penetration means and enables an administrator to cause the proximal end of the bone penetration means to penetrate part of a bone and part of the underlying marrow of the patient; and

(c) a fluid conveyance means which is connected to the lumen fluid transmission means at the distal end of the bone penetration means.

27. An apparatus comprising:

(a) a bone penetration means with a proximal end and a distal end and lumen fluid transmission means therein extending from the proximal end to the distal end;

(b) an applicator means which detachably engages the bone penetration means and enables an administrator to cause the proximal end of the bone penetration means to penetrate part of a bone and part of the underlying marrow of the patient; and

(c) bone stop, means, a proximal side of the bone stop means adapted to impinge against the surface of the bone of the patient when the proximal end of the bone penetration means penetrates the surface bone and a part of the marrow of the patient.