Patch for locating a target zone for penetration

• US 20040220497A1
• Filed: 06/04/2004
• Published: 11/04/2004
• Est. Priority Date: 03/02/2000
• Status: Active Grant

• Current Assignee: PYNG Medical Corporation (Teleflex Incorporated)
• Original Assignee: PYNG Medical Corporation (Teleflex Incorporated)
• Inventors: Johnson, David L., Jacobs, Michael W., Krasnich, Misha, Findlay, Judith M.
• Granted Patent: US 7,347,840 B2
• Time in Patent Office: Days
• US Class Current: 600/562
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

This invention relates to an apparatus and method for infusing fluids to and aspirating tissue from an intraosseous site. The apparatus is comprised of an infusion tube coupled to an introducer with a release mechanism that removes the force exerted on the infusion tube once it has penetrated the bone a predetermined depth. As the introducer is withdrawn, the infusion tube remains in the bone. The ball release mechanism and other aspects of the apparatus can be modified to yield different penetration depths. The present invention also relates to a method and apparatus for locating the site of infusion and for relieving strain and stress on the infusion site. The template patch uses a key anatomical feature of the bone as a reference point to a target zone for infusion that is located a predetermined distance away from the feature. The template patch has a tube clamp and a covering that protect the infusion site from external forces.

Claims

1. An apparatus for positioning an object a predetermined distance within a hard shell of material covered by a layer of soft material, characterized by a pusher (5, 16) coupled to said object (21), said pusher (5,16) operative to receive force applied by a user and transfer the applied force to said object, a coupler (7) operative to removably couple said pusher to said object during positioning of said object, a position probe (31) coupled to said object operative to penetrate said layer of soft material and stop at said hard shell of material and a release mechanism operative to remove substantially all of the applied force transferred to said object once said object reaches a predetermined depth below an end of said position probe.

2. Apparatus according to claim 1, wherein said pusher includes an outer cylindrical sleeve (5) having a ball race (9), and a cap (16), and an inner cylindrical sleeve (6) having a plurality of ball holes (10), slidably coupled within said outer cylinder sleeve (5) by said coupler (7).

3. Apparatus according to claim 2, wherein said coupler is a plurality of balls (7) positionable in said ball holes (10) in said inner cylindrical sleeve (6), and in said ball race (9) in said outer cylindrical sleeve so as to couple said inner and outer cylindrical sleeves.

4. Apparatus according to claim 1, including a housing assembly (2), wherein said object is removably coupled to said housing (2), said release mechanism is a part of said housing assembly (2), and said pusher is a part of said housing assembly (2) to which a user applies force, and said release mechanism is operative to remove substantially all of the force applied to said object once a portion of said object has penetrated the predetermined depth in said hard shell of material.

5. Apparatus according to claim 4, wherein said hard shell of material is a bone cortical layer (40), said layer of soft material is skin and subcutaneous tissue (56, 57) overlying said bone cortical layer, and said housing assembly (2) is removably coupled to said object so that upon insertion into a patient, said object penetrates said bone cortical layer the predetermined distance and, upon withdrawal of said housing assembly (2), said object is left in the body of the patient.

6. Apparatus according to claim 5, wherein said object is an infusion tube (17) and said position probe (31) is a bone probe assembly (3) that includes a plurality of needles which abut and are stopped by said bone cortical layer, and a spring (13) that compresses and allows the infusion tube to advance beyond the position of the tips of said plurality of needles, said tips of said plurality of needles being positioned a predetermined distance from the position of said infusion tube within said bone cortical layer.

7. Apparatus according to claim 6, wherein said housing assembly (2) comprises:

(a) an outer sleeve (5) having a cylindrical shape and a ball race (9) in an interior surface thereof proximate to an open end thereof;

(b) an inner sleeve (6), having a cylindrical shape slidably insertable in said outer sleeve (5), and having a plurality of ball holes (10) circumferentially spaced about said inner sleeve (6);

(c) a plurality of balls (7) positionable to engage said ball race (9) of said outer sleeve (5) and to pass through corresponding ones of the ball holes (10) of said inner sleeve (6) thereby coupling said outer sleeve (5) to said inner sleeve (6);

(d) a spring assembly having a spring (13) situated between said bone probe assembly (3) and an end of said inner sleeve (6) remote from said bone probe assembly (3);

wherein said bone probe assembly (3) is slidable in said inner sleeve (6) and has an outer surface with a conical shape (29) that reduces in diameter towards an end of a part of the bone probe assembly that contacts the patient; and

wherein upon the application of force to said outer sleeve (5), said plurality of balls (7) couple said inner sleeve (6) to said outer sleeve (5) and cause said spring (13) to compress between said bone probe assembly (3) and an end of said inner sleeve (6) and said plurality of balls (7) to travel along said outer surface with a conical shape (29) of said bone probe assembly (3) to a reduced diameter of said bone probe until said infusion tube has penetrated said cortical layer (40) the predetermined depth and said outer sleeve (5) is released from said inner sleeve (6) by said balls (7) moving inward to the center until said outer sleeve (5) is no longer coupled to said inner sleeve (6).

8. Apparatus according to claim 7, including a coupling between said inner sleeve (6) and said bone probe assembly (3) which permits relative motion between said inner sleeve (6) and said bone probe assembly (3) to an extent slightly beyond that at which said release mechanism is activated.

9. Apparatus according to claim 8, wherein said coupling includes an elongated slot (11) in said inner sleeve (6) and a pin (28) engaging said slot in said bone probe assembly (3).

10. Apparatus according to claim 7, wherein said bone probe assembly (3) comprises a bone probe ring (4) having a conical surface portion (29) with a wider portion of said bone probe ring (4) at an end remote from said plurality of needles (31) and a narrower end adjacent to said plurality of needles (31), said plurality of needles (31) extending from said bone probe ring (4), said bone probe assembly (3) having a plurality of pins (28) protruding therefrom engageable with elongated pin slots (11) in said inner sleeve (6).

11. Apparatus according to claim 7, wherein said infusion tube (17) is for aspirating tissue from and infusing fluid into the bone marrow (55) and said infusion tube includes a bone portal (21) and a hollow flexible tube (18) affixed thereto.

12. Apparatus according to claim 11, wherein said bone probe assembly (3) has an axial opening therethrough to permit passage of said infusion tube (17) and including two elongated support sleeves (33) for slidable insertion of said infusion tube (17) between said support sleeves (33) through the axial opening of said bone probe assembly (3) so as to support said infusion tube (17) during the application of force thereto.

13. Apparatus according to claim 11, wherein said bone probe assembly (3) comprises a plurality of bevel-tipped needles (31) which protrude from the bone probe ring (4) parallel to an axis thereof.

14. Apparatus according to claim 13, wherein said needles (31) encircle the bone portal (21).

15. Apparatus according to claim 13, including a protective covering (32) which fits over said needles having a hard outer shell.

16. Apparatus according to claim 11, wherein said housing assembly (2) includes a rigid stylet (50) passing through said hollow flexible tube (18) and contacting said bone portal (21) wherein force applied to said outer sleeve (5) translates to said inner sleeve (6), to said stylet (50) and to said bone portal (21).

17. Apparatus according to claim 11, wherein said infusion tube (17) includes a tube connector (20) fastened to a distal end of said hollow flexible tube (18), said tube connector (20) connectable to an external connector tube to increase slack in said infusion tube (17), prevent stress on said infusion tube (17) and said bone portal (21) and facilitate the infusion of fluids into a patient.

18. Apparatus according to claim 7, wherein after movement of said balls (7) from said ball race (9), said spring (13) exerts a force on said bone probe assembly (3), causing the outer surface with a conical shape (29) around an exterior thereof to bias said balls outwardly against said outer sleeve (5) and functionally couple said bone probe assembly (3), said inner sleeve (6) and said outer sleeve (5) together.

19. Apparatus according to claim 16, wherein a bone penetrating end (62) of said bone portal (21) is tapered.

20. Apparatus according to claim 16, wherein said bone portal (21) is stainless steel.

21. Apparatus according to claim 16, wherein said bone portal (21) has a passageway along a length thereof open to a tip at one end and to an opposite end thereof.

22. Apparatus according to claim 16, including threads (22) formed in the passageway of said bone portal (21).

23. Apparatus according to claim 16, including a remover (23) wherein said remover (23) is an elongated rod having threads at one end which register with threads (22) in said passageway of said bone portal (21) so that upon application of an extraction force on said remover, said bone portal (21) is withdrawn from bone of a patient.

24. A patch (34) for locating a target zone for penetration having a patch base (47) positionable over skin (56) of a patient, characterized by having a curved finger engaging recess at a predetermined distance from a target aperture (37), said curved finger engaging recess allowing an administrator to engage said curved finger engaging recess with an administrator'"'"'s finger which is palpating a predetermined landmark on the patient, so that said target aperture (37) is positioned over a desired area of penetration of the bone of a patient.

26. A patch according to claim 24, including a tube clamp (39) on said patch base (47) operative to stabilize an infusion tube (17) and minimize stress on a hollow flexible tube (18) caused by external forces.

27. A patch according to claim 24, including a strip of fastening material (38) extending around a periphery of said patch base (47) and a covering having fastening material (45) engageable with said fastening material on said patch base (47) and, when so engaged, operative to protect said patch base (47) and a hollow flexible tube (18) from direct contact with external forces.

28. A patch according to claim 24, wherein said patch base (47) has an extended region outside of said fastening strip for clamping one of infusion tube and a hollow flexible tube fastenable to said infusion tube.

29. A patch according to claim 27, wherein said covering is a transparent dome (46).

30. A patch according to claim 24, including a tube clamp (39) and a connector tube (41) attached to said tube clamp designed to connect to the infusion tube to prevent stress on said infusion tube caused by external sources.

25. A patch according to claim 25, wherein said feature of bone is a sternal notch (36) and said target aperture (37) is positioned relative to said sternal notch so as to be over a desired area of penetration of the manubrium bone.