Stick-free syringe and associated methods

• US 5,554,130 A
• Filed: 05/17/1995
• Issued: 09/10/1996
• Est. Priority Date: 05/17/1995
• Status: Expired due to Fees

• Current Assignee: Creative Bio Tech, Inc.
• Original Assignee: Creative Bio Tech, Inc.
• Inventors: Monteith, John, Monteith, Mark, Sturtevant, Charles N. III, McDonald, James
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US08/443,597
• Time in Patent Office: 482 Days
• Field of Search: 604/110, 604/187, 604/192, 604/195, 604/198, 604/263, 128/763-765
• US Class Current: 604/198
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150656 semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 5/3271 with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• CPC Class Codes: A61M 5/3272 having projections following labyrinth paths

Abstract

A stick-free blood collection system includes elongated inner and outer sheaths and a syringe, including a needle and blood collection tube, mounted with the inner sheath. The inner sheath--and hence the syringe--are axially moveable within the outer sheath. The outer sheath has a small aperture at the distal end thereof to permit passage of the needle through the outer sheath and into the patient. The outer sheath also includes an angled flat portion at the distal end to mount the outer sheath onto the patient in a practical fashion whereby the needle can be telescopically injected into the patient. During operation, the outer sheath is mounted at an angle relative to the surface of the patient, and the needle enters the surface at that angle to draw blood therein. The inner and outer sheaths have mating interconnections which engage when a user twists the inner sheath relative to the outer sheath, thereby preventing axial displacement of one sheath relative to the other sheath. Via this twisting motion, a user of the invention secures the needle within the outer sheath so as to prevent inadvertent contact with the used needle. The interconnections also generate an audible "click" when becoming engaged, thereby indicating that the system is safely locked. An aiming slot provides for visual access of the needle along the elongated axis; and the slot and the interface section provide a target site to predict the entry point of the needle into the patient. A lip at the distal end of the inner sheath provides for convenient handling of the inner sheath and syringe, and provides for smooth control of the system during replacement of the blood collection tube, e.g., a vacu-chamber.

Claims

1. A sheath for controlling a hypodermic syringe, the syringe of the type which includes (i) a blood collection tube and (ii) a hypodermic needle for drawing blood from a patient and into the tube, comprising:

an elongated tubular safety holder forming an axial cavity between a distal end and a proximal end, the distal end forming an aperture with a diameter that is greater than the diameter of the needle and less than the diameter of the tube, the holder having means for slideably engaging the syringe within

the cavity and between a first position, wherein the needle protrudes through the aperture, and a second position, wherein the holder substantially encloses the needle, the holder further having a substantially flat portion at the distal end for mounting the holder onto the patient, the flat portion stabilizing contact between the sheath and the patient and forming an angle relative to the elongated axis of the sheath, thereby controlling the angle at which the needle draws blood from the patient, and

means for securing the syringe at the second position such that the syringe is substantially restricted from movement along the elongated axis of the holder.

4. A sheath according to claim 1, further comprising gripping means for gripping and controlling the syringe within the sheath, the gripping means providing physiological control of the syringe within, and along the elongated axis of, the sheath.

5. A sheath according to claim 1, wherein the holder is formed of a transparent medically-accepted material.

6. A sheath according to claim 1, wherein the holder is formed of material selected from the group consisting essentially of polyethylene and polycarbonite.

7. A sheath according to claim 1, wherein the holder further comprises a lip extending outwardly and substantially circumferentially about the holder at the proximal end thereof, the lip providing a human grip to grasp and control the sheath.

13. A sheath according to claim 1, further comprising an adhesive cover for selectively covering the means for securing the syringe at the second position, the adhesive cover protecting against a possible re-use of the sheath.

2. A sheath for controlling a hypodermic syringe, the syringe of the type which includes (i) a blood collection tube and (ii) a hypodermic needle for drawing blood from a patient and into the tube, comprising:

an elongated tubular safety holder forming an axial cavity between a distal end and a proximal end, the distal end forming an aperture with a diameter that is greater than the diameter of the needle and less than the diameter of the tube, the holder having means for slideably engaging the syringe within the cavity and between a first position, wherein the needle protrudes through the aperture, and a second position, wherein the holder substantially encloses the needle,

means for securing the syringe at the second position such that the syringe is substantially restricted from movement along the elongated axis of the holder, and

patient interface means, rigidly connected with the sheath, for mounting the distal end onto the patient, the patient interface means being non-interfering with axial movement of the syringe and having a substantially flat portion for stabilizing contact between the sheath and the patient, the flat portion forming an angle relative to the axial cavity of the sheath, thereby controlling the angle at which the needle enters the patient.

3. A sheath according to claim 2, wherein the angle is between approximately 10 and 80 degrees.

8. A sheath for controlling a hypodermic syringe, the syringe of the type which includes (i) a blood collection tube and (ii) a hypodermic needle for drawing blood from a patient and into the tube, comprising:

an elongated tubular safety holder forming an axial cavity between a distal end and a proximal end, the distal end forming an aperture with a diameter that is greater than the diameter of the needle and less than the diameter of the tube, the holder having means for slideably engaging the syringe within the cavity and between a first position, wherein the needle protrudes through the aperture, and a second position, wherein the holder substantially encloses the needle, and

means for securing the syringe at the second position such that the syringe is substantially restricted from movement along the elongated axis of the holder

and for selectively restricting axial movement of the syringe within the holder upon a rotational twist, about the elongated axis, of the holder relative to the syringe.

9. A sheath according to claim 8, wherein the rotational twist is between approximately 20 and 180 degrees.

10. A sheath according to claim 8, wherein the means for securing the syringe at the second position further comprises means for restricting the rotational movement about the elongated axis of the syringe relative to the holder.

11. A sheath according to claim 8, wherein the means for securing the syringe at the second position further comprises means for generating an audible sound once the syringe is engaged at the second position.

12. A sheath according to claim 8, wherein the rotational twist is approximately 90 degrees and wherein the angle is approximately 45 degrees.

14. A blood collection system for controlling and securing a hypodermic needle, comprising:

an tubular safety holder forming an axial cavity between a distal end and a proximal end,

a syringe including (i) blood collection tube and (ii) a hypodermic needle for drawing blood from a patient and into the tube, the syringe being telescopically disposed within the axial cavity,

means for slideably engaging the syringe within the cavity and between a first position, wherein the needle protrudes from the distal end, and a second position, wherein the holder substantially encloses the needle,

means for securing the syringe at the second position selectively such that the syringe is substantially restricted from movement along the elongated axis, and

patient interface means, rigidly connected with the holder, for mounting the distal end onto the patient, the patient interface means having a substantially flat portion for stabilizing contact between the sheath and the patient, the flat portion forming an angle relative to the elongated axis of the sheath, thereby controlling the angle at which the needle enters the patient.

15. A blood collection system according to claim 14, wherein the needle has a first diameter, and wherein the distal end forms an aperture having a second diameter that is greater than the first diameter such that the needle passes unrestricted through the aperture.

16. A system for controlling a hypodermic syringe, the syringe of the type which includes (i) a blood collection tube and (ii) a hypodermic needle for drawing blood from a patient and into the tube, comprising:

an elongated outer sheath forming an axial cavity between an outer distal end and an outer proximal end, the outer distal end forming an aperture with a diameter that is greater than the diameter of the needle and less than the diameter of the tube, and

an elongated inner sheath disposed telescopically within the outer sheath, the inner sheath having an inner distal end and an inner proximal end, and having first means at the inner distal end for mounting the needle rigidly to the inner sheath such that the needle extends outwardly away from the inner distal end and along the axial cavity, the inner sheath being moveable along the axial cavity and between a first position, wherein the needle protrudes through the aperture, and a second position, wherein the outer sheath substantially encloses the needle,

wherein the outer sheath further comprises a first mating interconnection, and the inner sheath further comprises a second mating interconnection, the first and second mating interconnections being interlocking at the second position upon the axial rotation of the inner sheath relative to the outer sheath, wherein the inner sheath is substantially immovable, relative to the outer sheath, along the axial cavity.

17. A system according to claim 16, further comprising patient interface means for mounting the outer distal end onto the patient, the patient interface means being non-interfering with axial movement of the needle and having a substantially flat portion for stabilizing contact between the sheath and the patient, the flat portion forming an angle relative to the axial cavity of the sheath, thereby controlling the angle at which the needle enters the patient.

18. A system according to claim 16, wherein the inner sheath further comprises a lip extending outwardly and substantially circumferentially about the inner sheath at the inner proximal end thereof, the lip providing a human grip to grasp and control the sheath.

19. A system according to claim 16, wherein the first and second mating interconnections generating, in combination, an audible sound when the interconnections become locked.

20. A system according to claim 16, further comprising an aiming slot in the distal outer sheath, the aiming slot providing visual access to the needle during travel between the first and second positions.

21. A system according to claim 20, wherein the patient interface section and the aiming slot form, in combination, a target site for which a user of the system predicts entry of the needle into the patient.

22. A method for controlling a hypodermic syringe, the syringe of the type which includes (i) a blood collection tube and (ii) a hypodermic needle for drawing blood from a patient and into the tube, comprising the steps of:

mounting the needle to an elongated inner sheath that is telescopically disposed within an elongated outer sheath, the outer sheath forming (i) an axial cavity between an outer distal end and an outer proximal end, and (ii) an aperture with a diameter that is greater than the diameter of the needle and less than the diameter of the tube, the inner sheath having an inner distal end and an inner proximal end, the needle being mounted such that the needle extends outwardly away from the inner distal end and along the axial cavity,

moving the inner sheath relative to the outer sheath and along the axial cavity between a first position, wherein the needle protrudes through the aperture, and a second position, wherein the outer sheath substantially encloses the needle, and locking the inner and outer sheaths together at the second position upon the axial rotation of the inner sheath relative to the outer sheath, wherein the inner sheath is substantially immovable, relative to the outer sheath, along the axial cavity.