CA2599945A1 - Catheter introducer with needle shield - Google Patents

Catheter introducer with needle shield Download PDF

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Publication number
CA2599945A1
CA2599945A1 CA002599945A CA2599945A CA2599945A1 CA 2599945 A1 CA2599945 A1 CA 2599945A1 CA 002599945 A CA002599945 A CA 002599945A CA 2599945 A CA2599945 A CA 2599945A CA 2599945 A1 CA2599945 A1 CA 2599945A1
Authority
CA
Canada
Prior art keywords
needle
catheter introducer
blocking object
assembly
introducer assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002599945A
Other languages
French (fr)
Other versions
CA2599945C (en
Inventor
Timothy J. Erskine
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Erskine Medical LLC
Original Assignee
Erskine Medical Llc
Timothy J. Erskine
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Erskine Medical Llc, Timothy J. Erskine filed Critical Erskine Medical Llc
Publication of CA2599945A1 publication Critical patent/CA2599945A1/en
Application granted granted Critical
Publication of CA2599945C publication Critical patent/CA2599945C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • A61M25/0625—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3269—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel guided by means not coaxially aligned with syringe barrel, e.g. channel-like member formed on exterior surface of syringe barrel for guiding a pushing rod connected to and displacing needle safety sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3273—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Abstract

A needle assembly with a needle shield is disclosed. The shield includes a lumen slidable on the needle, a holder and a needle blocking object which moves at least partially into the lumen in order to block distal movement of the needle. A spring biases the blocking object towards the needle axis.
Proximal movement of the needle relative to the shield is limited by a restraint in the form of a discontinuity on the needle which abuts the shield, a tether or a tube abutting the needle hub. When the needle shield moves from a non-shielding position to a shielding position, the needle blocking object moves at least partially into the lumen. The needle blocking object is radially and axially constrained in the shielding position. The holder also prevents radial, longitudinal and circumferential movement of the blocking object. In one embodiment, the needle blocking object is a ball. A catheter adapter and tube may be threaded over the needle. The needle blocking object may also lock the catheter adapter to the needle shield, allowing it to be released only when the needle is shielded.

Claims (50)

1. A catheter introducer assembly comprising:

a needle comprising a longitudinal axis, a proximal end, a sharp distal end and an outer surface;

a catheter assembly comprising a catheter adapter and a catheter tube coaxial with the needle;

a needle shield assembly comprising:

a shield housing comprising an internal lumen, the shield housing being slidable along the outer surface of the needle;

a holder;

a blocking object;

wherein the holder maintains the blocking object in contact with the outer surface of the needle when the needle shield assembly is in a first, non-shielding position;
and wherein in a second, shielding position, the holder allows the blocking object to further enter the internal lumen, thereby blocking distal movement of the needle;
a restraint associated with the needle shield assembly for preventing movement of the needle shield assembly off the sharp distal end of the needle.
2. The catheter introducer assembly of claim 1 wherein the holder comprises a spring imparting a force on the blocking object to bias the blocking object towards the outer surface of the needle in the first, non-shielding position.
3. The catheter introducer assembly of claim 1 wherein the blocking object has a blocking object axis and wherein, in the second, shielded position, the blocking object axis is offset from the longitudinal axis of the needle.
4. The catheter introducer assembly of claim 1 wherein the holder comprises an opening in the shield housing, the opening extending from an outer wall of the shield housing to the lumen of the shield housing.
5. The catheter introducer assembly of claim 1 wherein the holder constrains movement of the blocking object in a direction around the longitudinal axis of the needle.
6. The catheter introducer assembly of claim 1 wherein the holder constrains movement of the blocking object in a direction generally parallel to the longitudinal axis of the needle.
7. The catheter introducer assembly of claim 1 wherein, in the second, shielding position, the holder constrains movement of the blocking object in a direction radially outward of the longitudinal axis of the needle.
8. The catheter introducer assembly of claim 1 wherein the needle shield assembly further comprises a cap at least partially covering the shield housing.
9. The catheter introducer assembly of claim 8 wherein the cap is provided with a side hole, through which the blocking object protrudes in the first non-shielding position.
10. The catheter introducer assembly of claim 8 wherein the spring is a compression spring.
11. The catheter introducer assembly of claim 8 wherein the spring is a torsion spring.
12. The catheter introducer assembly of claim 8 wherein the spring is a leaf spring.
13. The catheter introducer assembly of claim 8 wherein the spring is a wave washer.
14. The catheter introducer assembly of claim 2 wherein the spring is generally parallel to the longitudinal axis of the needle.
15. The catheter introducer assembly of claim 2 wherein the spring is coaxial with the needle.
16. The catheter introducer assembly of claim 4 wherein the opening in the shield housing is configured to prevent the blocking object from fully entering the lumen.
17. The catheter introducer assembly of claim 1 wherein the restraint comprises a discontinuity on the surface of the needle and the needle shield assembly engages the discontinuity in the second, shielding position.
18. The catheter assembly of claim 1 farther comprising a needle hub wherein the restraint comprises a tether between the needle shield assembly and the hub.
19. The catheter assembly of claim 1 further wherein the restraint comprises a tube.
20. The catheter assembly of claim 1 wherein the blocking object is a ball.
21. The catheter assembly of claim 1 wherein the blocking object is a roller.
22. The catheter assembly of claim 1 wherein blocking object is non-spherical.
23. A catheter introducer assembly comprising:

a needle comprising a longitudinal axis, a proximal end, a sharp distal end and an outer surface;

a catheter assembly comprising a catheter adapter and a catheter tube coaxial with the needle, wherein the catheter adapter is provided with a detent;

a needle shield assembly comprising:

a shield housing comprising an internal lumen and slidable along the outer surface of the needle;

a holder;

a blocking object;

wherein in a first, non-shielding position the holder maintains the blocking object in contact with the outer surface of the needle and the blocking object engages with the detent;

and wherein in a second, shielding position, the holder allows the ball to enter the internal lumen at least partially, and disengage from the detent, thereby blocking distal movement of the needle and releasing the needle shield assembly from the catheter;

a restraint associated with the needle shield assembly for preventing movement of the needle shield assembly off the sharp distal end of the needle.
24. The catheter introducer assembly of claim 23 wherein the detent is provided on an inner surface of the catheter adapter.
25. The catheter introducer assembly of claim 23 wherein the needle shield fits at least partially within the catheter adapter.
26. The catheter introducer assembly of claim 23 wherein the holder comprises a spring which exerts a biasing force on the blocking object towards the outer surface of the needle.
27. The catheter introducer assembly of claim 23 wherein, in the non-shielding position, the needle exerts a force on the blocking object which maintains the blocking object in engagement with the detent.
28. The catheter introducer assembly of claim 23 wherein the spring lies generally parallel to the longitudinal axis of the needle.
29. The catheter introducer assembly of claim 23 wherein the spring is coaxial with the needle.
30. The catheter introducer assembly of claim 23 wherein the spring is a compression spring.
31. The catheter introducer assembly of claim 23 wherein the spring is a torsion spring.
32. The catheter introducer assembly of claim 23 wherein the spring is a leaf spring.
33. The catheter introducer assembly of claim 23 wherein the spring is a wave washer.
34. The catheter introducer assembly of claim 23 wherein the shield comprises an opening in the shield housing.
35. The catheter introducer assembly of claim 23 wherein the shield comprises an outer wall and the ball holder comprises an opening from the outer wall to the internal lumen.
36. The catheter introducer assembly of 23 wherein the detent is a depressed portion.
37. The catheter introducer assembly of 23 wherein the detent is a circumferential groove.
38. The catheter introducer assembly of 23 wherein the detent is a raised portion.
39. The catheter introducer assembly of claim 23 wherein the detent is a circumferential raised portion.
40. The catheter introducer assembly of 23 wherein the holder is configured to permit limited movement of the blocking object radially inwards towards the needle.
41. The catheter introducer assembly of 23 wherein the holder is configured to permit limited movement of the blocking object around the longitudinal axis of the needle.
42. The catheter introducer assembly of 23 wherein the holder is configured to permit limited movement of the blocking object generally parallel to the longitudinal axis of the needle.
43. The catheter introducer assembly of claim 23 wherein the spring constrains the blocking object in a radial direction relative to the longitudinal axis of the needle in the second shielding position.
44. The catheter introducer assembly of claim 23 wherein the housing comprises a wall which constrains the blocking object in a radial direction relative to the longitudinal axis of the needle in the second shielding position.
45. The catheter introducer assembly of claim 23 wherein the housing comprises a wall which constrains the blocking object in a direction generally parallel to the longitudinal axis of the needle in the second shielding position.
46. The catheter introducer assembly of claim 23 wherein the holder is configured to prevent the blocking object from fully entering the internal lumen in the shielding position.
47. The catheter introducer assembly of claim 23 wherein the blocking object has an axis and in the shielding position, the blocking object axis is offset from the longitudinal axis of the needle.
48. The catheter introducer assembly of claim 23 wherein the blocking object is a ball.
49. The catheter introducer assembly of claim 23 wherein the blocking object is a roller.
50. The catheter introducer assembly of claim 23 wherein the blocking object is non-spherical.
CA2599945A 2005-03-07 2006-03-06 Catheter introducer with needle shield Active CA2599945C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US65921305P 2005-03-07 2005-03-07
US65922605P 2005-03-07 2005-03-07
US65921705P 2005-03-07 2005-03-07
US60/659,226 2005-03-07
US60/659,217 2005-03-07
US60/659,213 2005-03-07
US71495405P 2005-09-07 2005-09-07
US60/714,954 2005-09-07
PCT/US2006/007911 WO2006096635A1 (en) 2005-03-07 2006-03-06 Catheter introducer with needle shield

Publications (2)

Publication Number Publication Date
CA2599945A1 true CA2599945A1 (en) 2006-09-14
CA2599945C CA2599945C (en) 2011-07-12

Family

ID=36953709

Family Applications (5)

Application Number Title Priority Date Filing Date
CA2599938A Active CA2599938C (en) 2005-03-07 2006-03-06 Method of making a needle shielding device
CA002599955A Abandoned CA2599955A1 (en) 2005-03-07 2006-03-06 Winged needle with needle shield
CA2599945A Active CA2599945C (en) 2005-03-07 2006-03-06 Catheter introducer with needle shield
CA2717845A Abandoned CA2717845A1 (en) 2005-03-07 2006-03-06 Method of making a needle shielding device
CA2599943A Active CA2599943C (en) 2005-03-07 2006-03-06 Needle shielding device

Family Applications Before (2)

Application Number Title Priority Date Filing Date
CA2599938A Active CA2599938C (en) 2005-03-07 2006-03-06 Method of making a needle shielding device
CA002599955A Abandoned CA2599955A1 (en) 2005-03-07 2006-03-06 Winged needle with needle shield

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA2717845A Abandoned CA2717845A1 (en) 2005-03-07 2006-03-06 Method of making a needle shielding device
CA2599943A Active CA2599943C (en) 2005-03-07 2006-03-06 Needle shielding device

Country Status (11)

Country Link
US (5) US8603041B2 (en)
EP (7) EP1861136B1 (en)
JP (6) JP4695184B2 (en)
CN (1) CN101862498A (en)
AU (5) AU2006220689B2 (en)
BR (3) BRPI0608413A2 (en)
CA (5) CA2599938C (en)
ES (5) ES2535983T3 (en)
HK (4) HK1115734A1 (en)
MX (4) MX2007010943A (en)
WO (4) WO2006096634A1 (en)

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