Infusion apparatuses and methods of use

• US 8,147,455 B2
• Filed: 04/27/2006
• Issued: 04/03/2012
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Stats, Jason R., Hamatake, Bret, Rome, Sandra J., Shang, Walter H., Butts, David M.
• Primary Examiner(s): Sirmons, Kevin C.
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US11/380,621
• Publication Number:
  US 20060253076A1
• Time in Patent Office: 2,168 Days
• Field of Search: 604/93.01, 604/164.01, 604/164.02, 604/166.01, 604/167.01, 604/167.02, 604/288.01, 604/523, 604/164.07, 604/164.08, 604/165.01, 604/165.02, 604/167.06, 604/288.02, 604/288.04, 604/48, 604/500, 604/506, 604/513, 604/117, 604/164.04, 604/174, 604/177, 604/201, 604/256, 604/264, 604/272, 604/524, 604/533, 604/534, 604/535, 604/537, 604/538, 604/539, 604/890.1, 128/DIG.26
• US Class Current: 604/167.02
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• 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 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/3273 freely sliding on needle shaft without connection to syringe or needle

Abstract

An exemplary infusion system for accessing an implanted device is disclosed comprising an insertion assembly, a hub comprising a sealable path configured to receive at least a portion of the insertion assembly, a flexible catheter attached to the hub and configured to receive at least a portion of the insertion assembly, and an extension tube attached to the hub. The hub may comprise a manifold element configured to provide fluid communication between the flexible catheter and the extension tube. The hub may also comprise a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter. The extension tube may also be configured to receive at least a portion of the insertion assembly. Exemplary methods of providing a fluid communication path to an implanted device are also disclosed.

Claims

1. An infusion apparatus for providing access to an implanted device, comprising:

an insertion assembly;

a hub including a body comprising a sealable path extending from a first opening in a first end of the body to a second opening in a second end of the body, a septum disposed in the sealable path and compressed in the hub body;

a unitary manifold element positioned in the hub body, a first portion of the manifold element positioned in the sealable path retaining the septum and preventing movement of the septum along the sealable path toward the second opening;

a flexible catheter having a proximal end inserted into the second opening and attached to the hub;

an extension tube in fluid communication with the hub through a third opening, a passageway formed in the hub body between the third opening and the sealable path, the manifold element having a second portion positioned in the passageway fluidly connecting the extension tube to the flexible catheter; and

a cap element in the sealable path at an end of the manifold element first portion, the cap element preventing movement of the septum in a direction toward the first opening.

2. The infusion apparatus of claim 1, wherein the hub further comprises a plurality of wing structures.

3. The infusion apparatus of claim 1, wherein the insertion assembly comprises a slender pointed element and both the sealable path and the flexible catheter are configured to receive at least a portion of the slender pointed element.

4. The infusion apparatus of claim 3, wherein the extension tube is connected to a removable member, the removable member including a needle insertable through the third opening and a coupling structure mating with a recess in the hub body.

5. The infusion apparatus of claim 3, wherein the flexible catheter comprises at least one aperture defined proximate a distal end of the flexible catheter and the slender pointed element comprises at least one longitudinally extending indentation defined along the slender pointed element.

6. The infusion apparatus of claim 5, wherein a cross-sectional area defined between an exterior surface of the slender pointed element and an interior surface of the flexible catheter approximates the cross-sectional area of a hollow needle gauge.

7. The infusion apparatus of claim 3, wherein:

the flexible catheter comprises at least one aperture defined proximate a distal end of the flexible catheter; and

the slender pointed element is at least partially hollow and comprises at least one aperture defined within the slender pointed element for communicating fluid with the at least one aperture defined in the flexible catheter.

8. The infusion apparatus of claim 3, wherein at least a portion of the slender pointed element is retractable into a recess defined in the insertion assembly.

9. The infusion apparatus of claim 3, further comprising a safety clip configured to retain a pointed end of the slender pointed element within the safety clip when the slender pointed element is removed from the hub and to allow the pointed end of the slender pointed element to pass through the safety clip when the slender pointed element is inserted into the hub.

10. The infusion apparatus of claim 1, wherein the flexible catheter has a length that exceeds an anticipated insertion length such that, when the flexible catheter is fully inserted into a device implanted within a patient, a bendable portion of the flexible catheter extends from a skin surface of the patient.

11. The infusion apparatus of claim 10, further comprising a pad member including a receiving enclosure configured to retain at least a portion of the hub.

12. The infusion apparatus of claim 1, further comprising a reinforcing member at least partially imbedded within the flexible catheter.

13. The infusion apparatus of claim 1, wherein the extension tube is removably attached to the hub.

14. A hub for an infusion set, comprising:

a hub body including a first path extending along a first longitudinal axis from a first opening in a first end of the body to a second opening in a second opposite end of the body, and a second path extending along a second longitudinal axis generally perpendicular to the first longitudinal axis from a third opening to the first path;

a unitary manifold element positioned in the hub body extending into the first path and the second path, the manifold element defining a plenum in fluid communication with the first, second, and third openings;

a flexible catheter having a proximal end inserted through the second opening and positioned at least partially in the manifold element, an outer surface of the flexible catheter attached to an inner surface of the manifold element;

an extension tube having a distal end inserted through the third opening of the hub body, the manifold element providing fluid communication between the extension tube and the flexible catheter; and

a compressed septum positioned in the first path and retained between the unitary manifold element and a securement cap, the securement cap including an aperture in fluid communication with the first path.

15. The hub according to claim 14, wherein a distal end of the extension tube is positioned at least partially in the manifold element, an outer surface of the extension tube attached to an inner surface of the manifold element.

16. An infusion set, comprising:

the hub according to claim 14; and

an infusion assembly including a slender pointed element, the distal end of the slender pointed element extending beyond a distal end of the flexible catheter when the infusion assembly is coupled to the hub for insertion into an implanted port.