CA2798020A1 - Integrated vascular delivery system with safety needle - Google Patents

Integrated vascular delivery system with safety needle Download PDF

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Publication number
CA2798020A1
CA2798020A1 CA2798020A CA2798020A CA2798020A1 CA 2798020 A1 CA2798020 A1 CA 2798020A1 CA 2798020 A CA2798020 A CA 2798020A CA 2798020 A CA2798020 A CA 2798020A CA 2798020 A1 CA2798020 A1 CA 2798020A1
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CA
Canada
Prior art keywords
sheath
hub
needle
cndot
catheter
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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
CA2798020A
Other languages
French (fr)
Other versions
CA2798020C (en
Inventor
Adrienne R. Harris
Steven B. White
Elyse Kemmerer
Nathan Farrell
Henry J. H. Brown
Ronald D. Duis
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Tangent Medical Technologies Inc
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Tangent Medical Technologies Inc
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Publication date
Application filed by Tangent Medical Technologies Inc filed Critical Tangent Medical Technologies Inc
Priority claimed from US13/111,716 external-priority patent/US8814833B2/en
Priority claimed from US13/111,693 external-priority patent/US8771230B2/en
Publication of CA2798020A1 publication Critical patent/CA2798020A1/en
Application granted granted Critical
Publication of CA2798020C publication Critical patent/CA2798020C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61M25/0618—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
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • 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
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/02—Holding devices, e.g. 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0693—Flashback chambers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

An integrated vascular delivery system and safety needle including: a frame having a catheter hub providing a first anchoring point and that receives a catheter that transfers fluid at an insertion site, and a stabilization hub providing a second anchoring point; a fluidic channel coupled to the catheter; a housing; a needle insertable through the frame; and a sheath telescopically engaged with the housing. The sheath couples to the frame such that needle removal from the frame transitions the sheath from a retracted position, in which the sheath exposes the needle, to an extended position in which the sheath surrounds the needle. The frame operates in a folded configuration in which each hub couples to the housing and/or sheath and in an unfolded configuration in which the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

Claims (105)

We Claim:
1. An integrated vascular delivery system with safety needle comprising:
.cndot. a frame including:

.circle. a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site; and .circle. a stabilization hub providing a second anchoring point on the patient;

.circle. wherein the frame operates in a folded configuration and in an unfolded configuration;

.cndot. a fluidic channel that fluidically communicates with the catheter;
.cndot. a housing including a needle mount;

.cndot. a needle having a distal end insertable through the frame and a proximal end coupled to the needle mount; and .cndot. a sheath telescopically engaged with the housing, wherein the sheath is coupleable to the frame such that removal of the needle from the frame draws the sheath over the needle, thereby transitioning the sheath from a retracted position in which the sheath exposes the distal end of the needle to an extended position wherein the sheath substantially surrounds the distal end of the needle;

.cndot. wherein in the folded configuration of the frame, the catheter hub and stabilization hub each couples to at least one of the housing and sheath; and .cndot. wherein in the unfolded configuration of the frame, the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.
2. The system of Claim 1, wherein in the folded configuration of the frame, the stabilization hub couples to the housing.
3. The system of Claim 1, wherein the unfolded configuration of the frame, one of the first and second anchoring points is configured to be proximal to the insertion site and the other one of the first and second anchoring points is configured to be distal to the insertion site, relative to the patient.
4. The system of Claim 1, wherein in the unfolded configuration of the frame, the first anchoring point is configured to be substantially opposite the second anchoring point.
5. The system of Claim 1, further comprising two lateral members extending between the catheter hub and stabilization hub.
6. The system of Claim 5, wherein the first and second lateral members are substantially parallel with the catheter.
7. The system of Claim 5, wherein the fluidic channel is disposed within one of the lateral members.
8. The system of Claim 1, wherein the fluidic channel includes a turnabout portion in which fluid flows in a direction substantially opposite from that within the catheter.
9. The system of Claim 8, wherein the turnabout portion of the fluidic channel is fixed within at least one of the catheter hub and stabilization hub.
10. The system of Claim 1, further comprising a third hub providing a third anchoring point around the insertion site.
11. The system of Claim 1, wherein the catheter hub includes recesses and the sheath includes flexible jaws extending from a distal end of the sheath that mate with the recesses on the catheter hub.
12. The system of Claim 1, further comprising a slider longitudinally engaged with the sheath and the housing.
13. The system of Claim 12, wherein the slider includes a restraint that selectively engages the sheath, wherein:

.cndot. when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the frame; and .cndot. when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the medical device.
14. The system of Claim 13, wherein the restraint is coupled to the sheath when the sheath is in the retracted position, and the restraint is uncoupled from the sheath when the sheath is in the extended position.
15. The system of Claim 14, wherein the sheath includes flexible jaws extending from a distal end of the sheath and biased to couple to the frame, wherein the restraint of the sheath is coupleable to the flexible jaws.
16. The system of Claim 15, wherein the distal end of the sheath includes two split portions, each split portion including one of the flexible jaws and a slot, and wherein the restraint of the sheath includes two tabs, wherein:

.cndot. when the restraint is coupled to the sheath, each tab is engaged with a respective slot, thereby substantially fixing the flexible jaws relative to one another, and .cndot. wherein when the restraint is uncoupled from the sheath, each tab is disengaged from its respective slot, thereby substantially allowing movement of the flexible jaws relative to one another.
17. The system of Claim 12, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.
18. The system of Claim 17, wherein the slider includes a substantially planar portion and a substantially nonplanar sheath insert portion that is telescopically engaged within the sheath.
i9. The system of Claim 17, wherein the housing includes a housing stop that is configured to abut the proximal articulation of the slider when the sheath is in the extended position.
20. The system of Claim 19, wherein the housing stop includes a snap lock cantilevered arm and the proximal articulation of the slider is a laterally outward extending tab.
21. The system of Claim 17, wherein the sheath includes a sheath stop that is configured to abut the distal articulation of the slider when the sheath is in the extended position.
22. The system of Claim 21, wherein the sheath stop is an aperture defined in a side wall of the sheath and the distal articulation of the slider is an extension that catches in the aperture when the sheath is in the extended position.
23. The system of Claim 1, wherein the housing includes a setting to which the needle mount is coupled, and wherein sheath includes a longitudinal track that is substantially parallel to a longitudinal axis of the sheath and slidingly engaged with the setting.
24. The system of Claim 23, wherein the longitudinal track includes:

.cndot. a first track portion that slidingly engages the setting of the housing to allow the sheath to retract in a proximal direction into the housing up to a first limit; and .cndot. a second track portion, approximately parallel to and circumferentially offset from the first track portion that slidingly engages the setting to allow the sheath to retract in the proximal direction into the housing beyond the first limit and up to a second limit.
25. The system of Claim 24, wherein the second track portion further slidingly engages the setting to allow the sheath to extend in a distal direction towards the extended position of the sheath.
26. The system of Claim 23, wherein when the sheath is in the extended position, a proximal portion of the sheath abuts a stop in the housing, thereby preventing overextension of the sheath in a distal direction beyond the housing.
27. The system of Claim 26, further comprising a locking mechanism configured to lock the sheath in the extended position.
28. The system of Claim 27, wherein the locking mechanism includes a snap lock cantilevered arm, wherein the snap lock cantilevered arm abuts a proximal portion of the sheath against the setting.
29. The system of Claim 23, wherein the sheath includes a proximal sheath piece and a separate distal sheath piece coupled to the proximal sheath piece.
30. The system of Claim 1, wherein the sheath is coupleable to an internal surface of the catheter hub.
31. The system of Claim 1, wherein the sheath is coupleable to an external surface of the catheter hub.
32. The system of Claim 1, wherein the catheter hub includes a hub septum having a hub septum length, a primary seal, a secondary seal, and a hub septum cavity defined between the primary seal and secondary seal.
33. The system of Claim 32, wherein the hub septum includes a rigid core and an elastomeric plug surrounding at least a portion of the core, wherein the rigid core includes a wall defining an aperture and a plurality of members extending from the wall.
34. The system of Claim 33, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the hub septum length is greater than or equal to the notch extent distance.
35. The system of Claim 33, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, and the sheath includes a sheath septum having a sheath septum length, wherein the sum of the hub septum length and the sheath septum length is greater than or equal to the notch extent distance.
36. The system of Claim 1, further comprising a cap with a lumen that receives and covers the needle when the frame is in the folded configuration and the sheath is in the retracted position.
37. The system of Claim 36, wherein the cap includes a recess that receives and couples to at least one of the housing.
38. The system of Claim 36, wherein the cap includes a recess that receives and couples to the stabilization hub
39. The system of Claim 1, further comprising a cap that couples to the frame in the unfolded configuration and to at least one of the needle, sheath, and housing when the sheath is in the retracted position, wherein the cap includes a lumen that receives and covers the needle
40. An integrated vascular delivery system adapted to be placed on a patient, comprising:

.cndot. a frame including:

.circle. a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site;

.circle. a stabilization hub providing a second anchoring point on the patient; and .circle. a flexible lateral member extending between the catheter hub and stabilization hub; and .cndot. a fluidic channel that fluidically communicates with the catheter;

.cndot. wherein the frame operates in:

.circle. a folded configuration wherein the catheter and stabilization hubs are coupleable to one another; and .circle. an unfolded configuration wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.
41. The system of Claim 40, wherein one of the catheter hub and stabilization hub includes an extension with an aperture, wherein in the folded configuration of the frame, the aperture is aligned with the other one of the catheter hub and stabilization hub.
42. The system of Claim 41, wherein in the folded configuration of the frame, the needle is insertable through the extension and the catheter hub, thereby coupling the catheter hub and stabilization hub to one another.
43. The system of Claim 40, wherein in the folded configuration of the frame, the catheter hub and stabilization hub each couples to at least one of the housing and sheath, thereby indirectly coupling the catheter hub and stabilization hub to one another.
44. The system of Claim 40, further comprising a lateral member extending between the catheter hub and stabilization hub.
45. The system of Claim 44, further comprising a second lateral member.
46. The system of Claim 45, wherein the first and second lateral members are substantially parallel with the catheter.
47. The system of Claim 44, wherein the fluidic channel is disposed within the lateral member.
48. The system of Claim 40, wherein the fluidic channel includes a turnabout portion in which fluid flows in a direction different from that within the catheter.
49. The system of Claim 48, wherein the turnabout portion of the fluidic channel directions fluid flow in a direction substantially opposite from that within the catheter.
50. The system of Claim 48, wherein the turnabout portion of the fluidic channel is fixed within at least one of the catheter hub and stabilization hub.
51. The system of Claim 40, wherein the catheter hub includes a hub septum having a hub septum cavity and a hub septum length.
52. The system of Claim B12, wherein the hub septum includes a primary seal and a secondary seal, wherein the hub septum cavity is defined between the primary and secondary seals.
53. The system of Claim 52, wherein the septum includes a rigid core and an elastomeric plug surrounding at least a portion of the core.
54. The system of Claim 53, wherein the rigid core includes a wall defining an aperture, and a plurality of members extending from the wall.
55. The system of Claim 51, wherein the hub septum includes a spring clip disposed inside the hub septum cavity.
56. The system of Claim 51, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the hub septum length is greater than or equal to the notch extent distance.
57. The system of Claim 40, further comprising a third hub providing a third anchoring point around the insertion site.
58. The system of Claim 57, wherein the first, second, and third anchoring points are distributed approximately equally around the insertion site.
59. The system of Claim 40, further comprising a needle shield, coupled to at least one of the catheter hub and stabilization hub, that engages the distal end of the needle.
60. The system of Claim 59, wherein the needle shield is removably coupled to the catheter hub.
61. The system of Claim 59, wherein the needle shield is removably coupled to the stabilization hub.
62. The system of Claim 59, wherein the needle shield includes a spring clip that engages a distal portion of the needle.
63. The system of Claim 40, further comprising:
.cndot. a housing including a needle mount;

.cndot. a needle having a distal end insertable through the frame and a proximal end coupled to the needle mount;

.cndot. a sheath telescopically engaged with the housing and operating in:

.circle. a retracted position, wherein the sheath exposes the distal end of the needle; and .circle. an extended position, wherein the sheath substantially surrounds the distal end of the needle;

.cndot. wherein the sheath is coupleable to the frame such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position.
64. The system of Claim 63, wherein in the folded configuration of the frame, the catheter hub couples to the sheath and the stabilization hub couples to at least one of the sheath and the housing, thereby indirectly coupling the catheter hub and stabilization hub to one another.
65. The system of Claim 63, further including a slider longitudinally engaged with the sheath and the housing.
66. The system of Claim 65, wherein the restraint selectively engages the sheath, wherein:

.circle. when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the frame; and .circle. when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the frame.
67. The system of Claim 65, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.
68. The system of Claim 63, wherein the catheter hub includes a hub septum having a hub septum cavity and a hub septum length, the sheath includes a sheath septum having a sheath septum length, and the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the sum of the hub septum length and the sheath septum length is greater than or equal to the notch extent distance.
69. The system of Claim 68, wherein the hub septum length is less than the notch extent distance.
70. A system with a safety needle, comprising:
.cndot. a housing including a needle mount;

.cndot. a needle having a distal end insertable through a medical device and a proximal end coupled to the needle mount;

.cndot. a sheath telescopically engaged with the housing and circumferentially surrounding at least a portion of the needle, wherein the sheath operates in:

.circle. a retracted position, wherein the sheath exposes the distal end of the needle; and .circle. an extended position, wherein the sheath substantially surrounds the distal end of the needle;

.circle. wherein the sheath is coupleable to a medical device such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position; and .cndot. a slider, longitudinally engaged with at least one of the sheath and the housing and including a restraint that selectively engages the sheath, wherein:

.circle. when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the medical device; and .circle. when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the medical device.
71. The system of Claim 70, wherein the restraint is coupled to the sheath when the sheath is in the retracted position, and the restraint is uncoupled from the sheath when the sheath is in the extended position.
72. The system of Claim 70, wherein the housing includes an inner portion that is telescopically engaged within the sheath.
73. The system of Claim 72, wherein the sheath is telescopically engaged around the slider.
74. The system of Claim 73, wherein the housing includes at least one arch that forms an outer framework at least partially around the sheath and slider.
75. The system of Claim 70, wherein the needle has a lumen.
76. The system of Claim 70, wherein the sheath includes a holding tab extending laterally outward from a distal end of the sheath.
77. The system of Claim 70, wherein the slider includes a substantially planar portion and a substantially nonplanar sheath insert portion that is telescopically engaged within the sheath.
78. The system of Claim 77, wherein the housing, sheath, and slider are longitudinally movable relative to one another.
79. The system of Claim 70, wherein the sheath includes flexible jaws extending from a distal end of the sheath and biased to couple to the medical device.
80. The system of Claim 79, wherein the flexible jaws surround a portion of the medical device.
81. The system of Claim 8o, wherein the restraint of the sheath is coupleable to the flexible jaws.
82. The system of Claim 8i, wherein the distal end of the sheath includes two split portions, each split portion including one of the flexible jaws and a slot, and wherein the restraint of the sheath includes two tabs, wherein:

.cndot. when the restraint is coupled to the sheath, each tab is engaged with a respective slot, thereby substantially fixing the flexible jaws relative to one another, and .cndot. wherein when the restraint is uncoupled from the sheath, each tab is disengaged from its respective slot, thereby substantially allowing movement of the flexible jaws relative to one another.
83. The system of Claim 79, wherein when the restraint is engaged with the sheath the jaws are in a closed configuration and when the restraint is disengaged from the sheath jaws are in an open configuration.
84. The system of Claim 70, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.
85. The system of Claim 84, wherein the housing includes a housing stop that is configured to abut the proximal articulation of the slider when the sheath is in the extended position.
86. The system of Claim 85, wherein the housing stop includes a snap lock cantilevered arm.
87. The system of Claim 86 wherein the proximal articulation of the slider is a laterally outward extending tab.
88. The system of Claim 84, wherein the sheath includes a sheath stop that is configured to abut the distal articulation of the slider when the sheath is in the extended position.
89. The system of Claim 88, wherein the sheath stop is an aperture defined in a side wall of the sheath.
90. The system of Claim 89, wherein the distal articulation of the slider is an extension that catches in the aperture.
91. The system of Claim 70, wherein the sheath includes a sheath septum defining a sheath septum cavity and a sheath septum length.
92. The system of Claim 91, wherein when the sheath is in the extended position, the septum cavity surrounds the distal end of the needle.
93. The system of Claim 92, wherein the needle further includes a needle catch that secures the septum cavity over the distal end of the needle.
94. The system of Claim 92, wherein the septum cavity includes a spring clip that secures the septum cavity over the distal end of the needle.
95. The system of Claim 92, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch and the sheath septum length is greater than or equal to the notch extent distance.
96. The system of Claim70, further comprising a frame including:

.cndot. a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site; and .cndot. a stabilization hub providing a second anchoring point on the patient;

.cndot. wherein the frame operates in a folded configuration and in an unfolded configuration;

.cndot. a fluidic channel that fluidically communicates with the catheter;

.cndot. wherein in the folded configuration of the frame, the catheter hub and stabilization hub each couples to at least one of the housing and sheath; and wherein in the unfolded configuration of the frame, the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.
97. The system of Claim 96, wherein the unfolded configuration of the frame, one of the first and second anchoring points is configured to be proximal to the insertion site and the other one of the first and second anchoring points is configured to be distal to the insertion site, relative to the patient.
98. The system of Claim 96, wherein the catheter hub includes a hub septum having a hub septum cavity and a hub septum length, the sheath includes a sheath septum having a sheath septum length, and the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the sum of the hub septum length and the sheath septum length is greater than or equal to the notch extent distance.
99. The system of Claim 98, wherein the hub septum length is less than the notch extent distance.
100. A method for stabilizing a catheter around a catheter insertion site on a patient, comprising:

.cndot. providing a frame including a catheter hub, a catheter coupled to the catheter hub, and a stabilization hub;

.cndot. providing a safety needle system including a housing with a needle mount, a needle coupled to the needle mount, and a sheath telescopically engaged with the housing, wherein the sheath operates in a retracted position that exposes a distal end of the needle and an extended position that covers the distal end of the needle;

.cndot. folding the catheter hub and stabilization hub towards one another, thereby folding the frame into a folded configuration;

.cndot. coupling the sheath in the retracted position to the catheter hub;
.cndot. inserting the catheter into the patient at an insertion site;

.cndot. pulling the housing away from the catheter hub, thereby drawing the sheath into the extended position;

.cndot. uncoupling the extended sheath from the catheter hub and locking the sheath in the extended position;

.cndot. unfolding the frame such that the frame surrounds the insertion site in an unfolded configuration; and .cndot. securing the frame to the patient at a plurality of anchoring points distributed around the insertion site, thereby stabilizing the catheter relative to the insertion site.
101. The method of Claim 100, wherein folding the catheter hub and stabilization hub further includes coupling the catheter hub and the stabilization hub.
102. The method of Claim 101, wherein coupling the sheath and the stabilization hub includes coupling at least one of the sheath and housing to the stabilization hub.
103. The method of Claim 100, wherein securing the frame includes securing the frame at at least two anchoring points on substantially opposite sides of the insertion site.
104. The method of Claim 103, wherein securing the frame includes securing the one of the catheter hub and stabilization hub at a first anchoring point proximal to the insertion site, and securing the other of the catheter hub and stabilization hub at a second anchoring point distal to the insertion site.
105. A septum in a fluid delivery system adapted to be placed on a patient, comprising:

.cndot. a rigid core having a core wall defining an elongated aperture;

.cndot. two members extending approximately perpendicularly from the core wall, wherein the two members are separated and approximately parallel;

.cndot. a cylindrical elastomeric plug circumferentially surrounding the two members and having a distal face opposing the wall of the rigid core and a proximal face occluding the aperture of the core wall;

.cndot. wherein a diameter of the elastomeric plug is smaller than a diameter of the core wall, such that the core wall forms a flange;

.cndot. wherein the distal face of the elastomeric plug defines a primary seal and the proximal face of the elastomeric plug provides a secondary seal; and .cndot. wherein the two members, the primary seal, and the secondary seal cooperatively define a cavity.
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US34629210P 2010-05-19 2010-05-19
US61/346,292 2010-05-19
US35222010P 2010-06-07 2010-06-07
US61/352,220 2010-06-07
US35677610P 2010-06-21 2010-06-21
US61/356,776 2010-06-21
US40779710P 2010-10-28 2010-10-28
US40777710P 2010-10-28 2010-10-28
US61/407,797 2010-10-28
US61/407,777 2010-10-28
US41834910P 2010-11-30 2010-11-30
US41835410P 2010-11-30 2010-11-30
US41835210P 2010-11-30 2010-11-30
US41835810P 2010-11-30 2010-11-30
US61/418,349 2010-11-30
US61/418,358 2010-11-30
US61/418,352 2010-11-30
US61/418,354 2010-11-30
US201161438778P 2011-02-02 2011-02-02
US201161438774P 2011-02-02 2011-02-02
US201161438781P 2011-02-02 2011-02-02
US201161438782P 2011-02-02 2011-02-02
US61/438,778 2011-02-02
US61/438,782 2011-02-02
US61/438,781 2011-02-02
US61/438,774 2011-02-02
US201161442456P 2011-02-14 2011-02-14
US61/442,456 2011-02-14
US201161448132P 2011-03-01 2011-03-01
US201161448140P 2011-03-01 2011-03-01
US61/448,132 2011-03-01
US61/448,140 2011-03-01
US201161448318P 2011-03-02 2011-03-02
US61/448,318 2011-03-02
PCT/US2011/037230 WO2011146764A1 (en) 2010-05-19 2011-05-19 Integrated vascular delivery system with safety needle
US13/111,716 US8814833B2 (en) 2010-05-19 2011-05-19 Safety needle system operable with a medical device
US13/111,693 2011-05-19
US13/111,693 US8771230B2 (en) 2010-05-19 2011-05-19 Integrated vascular delivery system
US13/111,716 2011-05-19

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CN102892457B (en) 2014-07-30
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WO2011146764A1 (en) 2011-11-24
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JP5582594B2 (en) 2014-09-03
CN102892457A (en) 2013-01-23

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