INFUSION APPARATUSES AND METHODS OF USE

• US 20060253076A1
• Filed: 04/27/2006
• Published: 11/09/2006
• 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: Foster, Reginald F., Stats, Jason R., Hamatake, Bret, Shang, Walter H., Butts, M. David, Rome, Guy, Farnworth, Charles L., Rome, Sandra J.
• Granted Patent: US 8,147,455 B2
• Time in Patent Office: Days
• US Class Current: 604/167.60
• 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 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;

wherein the hub is configured to provide fluid communication between the flexible catheter and the extension tube.

2. The infusion apparatus of claim 1, wherein the sealable path comprises a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter.

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

4. The infusion apparatus of claim 1, wherein the hub further comprises a manifold element structured to provide fluid communication between the flexible catheter and the extension tube.

5. 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.

6. The infusion apparatus of claim 5, wherein the extension tube is configured to receive at least a portion of the slender pointed element.

7. The infusion apparatus of claim 5, 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.

8. The infusion apparatus of claim 7, 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.

9. The infusion apparatus of claim 5, 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.

10. The infusion apparatus of claim 5, wherein at least a portion of the slender pointed element is retractable into a recess defined in the insertion assembly.

11. 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.

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

13. The infusion apparatus of claim 5, 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.

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

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

16. An infusion device for use with an implanted device, the infusion device comprising:

a slender pointed element comprising a pointed end;

a flexible catheter comprising a sealable path configured to receive at least a portion of the slender pointed element; and

an extension tube in fluid communication with the flexible catheter;

wherein the sealable path is structured to seal upon removal of the slender pointed element from the flexible catheter.

17. An infusion apparatus for accessing an implanted device, the infusion apparatus comprising:

an insertion assembly comprising a slender pointed element;

a hub comprising a sealable path configured to receive at least a portion of the slender pointed element;

a flexible catheter attached to the hub and configured to receive at least a portion of the slender pointed element; and

an extension tube attached to the hub;

wherein the hub comprises;

a manifold element structured to provide fluid communication between the flexible catheter and the extension tube; and

a septum configured to seal the sealable path upon removal of the slender pointed element from the flexible catheter.

18. A method of providing a fluid communication path to an implanted device, the method comprising:

positioning at least a portion of a slender pointed element within a flexible catheter;

penetrating a septum of an implanted device with the slender pointed element positioned within the flexible catheter;

positioning at least a portion of the flexible catheter within the implanted device;

removing the slender pointed element from the flexible catheter; and

retaining at least a portion of the flexible catheter within the implanted device.

19. The method of claim 18, further comprising:

providing a hub in fluid communication with the flexible catheter; and

removably attaching an extension tube to the hub to provide fluid communication between the flexible catheter and the extension tube.

20. The method of claim 19, further comprising sealing a sealable path defined in the hub upon removal of the slender pointed element from the flexible catheter.

21. The method of claim 19, further comprising positioning at least a portion of the slender pointed element within the extension tube.

22. The method of claim 18, further comprising retracting at least a portion of the slender pointed element into the flexible catheter.

23. The method of claim 18, further comprising:

providing a safety clip proximate a pointed end of the slender pointed element; and

retaining the pointed end of the slender pointed element within the safety clip upon removal of the slender pointed element from the flexible catheter.