Stabilization and guide apparatus for access to an implanted access port and related methods

• US 10,420,884 B2
• Filed: 03/05/2015
• Issued: 09/24/2019
• Est. Priority Date: 03/07/2014
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Howell, Glade H., VanderStek, Bradley J., Cox, Jeremy B., Whetstone, Laurie M., Shanmugham, Manikantan, Bown, Matthew W., Stats, Jason R., Sykes, Kenneth W.
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US14/639,706
• Publication Number:
  US 20150250944A1
• Time in Patent Office: 1,664 Days
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. In one embodiment, the insertion device comprises a body that includes a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion guides a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Claims

1. An insertion device for accessing an access port implanted under the skin of a patient with a needle assembly, the insertion device comprising:

a body including;

a stabilizing portion that stabilizes a position of the implanted access port when placed on the skin of the patient atop the implanted access port, the stabilizing portion defining an open-ended cavity having an outer perimeter circumscribing a portion of the implanted access port when the insertion device is placed on the skin of the patient atop the implanted access port, a portion of the needle assembly removably disposed in the open-ended cavity; and

a guide portion for guiding a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

2. The insertion device as defined in claim 1, wherein the stabilizing portion includes a lip around a bottom perimeter thereof.

3. The insertion device as defined in claim 1, wherein a plurality of finger cutouts are defined on the stabilizing portion, and wherein the outer perimeter defines a substantially round shape.

4. The insertion device as defined in claim 1, wherein the guide portion includes a needle guide.

5. The insertion device as defined in claim 1, wherein the guide portion includes a retainer component that releasably attaches to a needle hub of the needle assembly, the needle extending from the needle hub, the retainer component constraining movement of the needle in a distal and proximal direction along the predetermined path.

6. The insertion device as defined in claim 5, wherein the retainer component includes a projection that is slidably disposed within a slit that enables distal and proximal movement of the retainer component, the slit including a slit adjustment zone for adjusting a longitudinal length of the slit.

7. The insertion device as defined in claim 6, wherein the retainer component includes first and second articulating wings, each wing including a tooth that engages a portion of the needle hub to maintain releasable attachment of the retainer component with the needle hub.

8. The insertion device as defined in claim 7, wherein the guide portion further includes a channel in which the retainer component is slidably disposed, the channel including a parallel proximal portion and an outwardly tapered distal portion, wherein the first and second wings of the retainer component open when the retainer component is slid distally from the parallel proximal portion to the outwardly tapered distal portion, the distal sliding of the retainer component coinciding with the distal movement of the needle hub so as to enable the needle to pierce the septum of the implanted access port, the opening of the first and second wings causing the retainer component to release engagement with the needle hub.

9. The insertion device as defined in claim 7, wherein each of the first and second wings includes a pin, wherein the guide portion further includes first and second channels in which the pin of the respective first or second wing is slidably received, each of the first and second channels including a parallel proximal portion and an diverging distal portion, wherein the first and second wings of the retainer component open when the retainer component is slid distally, the opening of the first and second wings being caused by the distal movement of the first and second pins from the parallel proximal portion to the diverging distal portion of the first and second channels, the distal sliding of the retainer component coinciding with the distal movement of the needle hub so as to enable the needle to pierce the septum of the implanted access port, the opening of the first and second wings causing the retainer component to release engagement with the needle hub.

10. The insertion device as defined in claim 5, wherein the needle assembly includes a base that is slidably disposed on the needle, the base being the portion of the needle assembly removably disposed in the open-ended cavity.

11. The insertion device as defined in claim 10, wherein the body further includes a slot defined adjacent the open-ended cavity, the slot for enabling removal of the insertion device from the needle assembly when the needle has been inserted into the septum of the implanted access port.

12. An insertion device for accessing an access port implanted under the skin of a patient with a needle assembly, the insertion device comprising:

a body including;

a stabilizing portion defining an open-ended cavity having an outer perimeter circumscribing a portion of the implanted access port when the insertion device is placed on the skin of the patient atop the implanted access port, a portion of the implanted access port being received within the open-ended cavity, a portion of the needle assembly removably disposed in the open-ended cavity; and

a guide portion including a retainer component movably attached to the body and removably retaining a hub of the needle assembly, wherein the guide portion guides a needle of the needle assembly along a predetermined path through the open-ended cavity to transcutaneously pierce a septum of the implanted access port.

13. The insertion device as defined in claim 12, wherein the retainer component includes first and second articulating wings, each of the first and second articulating wings including a tooth that engages a portion of a needle hub of the needle assembly to maintain releasable attachment of the retainer component with the needle hub.

14. A needle insertion system for accessing an access port implanted under the skin of a patient, the system comprising:

a needle assembly including a base and a hub;

an insertion device, the needle assembly removably attached to the insertion device, the insertion device including;

a stabilizing portion that stabilizes a position of the implanted access port when placed on the skin of the patient atop the implanted access port, the stabilizing portion defining an open-ended cavity having an outer perimeter circumscribing a portion of the implanted access port when the insertion device is placed on the skin of the patient atop the implanted access port, the base removably disposed in the open-ended cavity; and

a guide portion for guiding a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

15. The needle insertion system as defined in claim 14, wherein the guide portion includes a retainer component that releasably attaches to the hub of the needle assembly and slides in a channel longitudinally defined on the insertion device.

16. The needle insertion system as defined in claim 15, wherein the guide portion is included with a body of the insertion device, the body including a plurality of articulating arms, a proximal end of each articulating arm removably attaching to a portion of the needle assembly, a distal end being attached to a portion of the body, wherein collapse of the articulating arms by user force guides the needle of the needle assembly to pierce the septum of the implanted access port.

17. The needle insertion system as defined in claim 15, wherein the guide portion is included with a body of the insertion device, the guide portion including a slide portion slidably disposed with the body, the slide portion releasably retaining the needle assembly, the insertion device further including a needle cover that is removably attached to a distal end of the body so as to protect a distal tip of the needle before use of the insertion device.

18. The needle insertion system as defined in claim 17, wherein the needle assembly is retained by the slide portion such that the distal tip of the needle is able to pivot about a longitudinal axis of the needle.

19. The needle insertion system as defined in claim 15, wherein the guide portion is at least partially defined by a body of the insertion device, the needle assembly being slidably disposed within a cavity defined by the body, the body further including a removable lower body portion, the lower body portion defining a lower body cavity, the lower body cavity defining the stabilizing portion.

20. The needle insertion system as defined in claim 19, wherein an antimicrobial barrier is disposed in one of the cavity and the lower body cavity of the lower body portion.

21. An insertion device for accessing an access port that is subcutaneously implanted in a body of a patient, the insertion device comprising:

a body defining a cavity for receiving therein at least a portion of the implanted access port and skin surface above the port, the body further defining;

a needle guide for guiding a needle for insertion into a septum of the implanted access port;

a slot for enabling removal of the insertion device past the needle after insertion into the septum of the implanted access port; and

at least one cutout for permitting deformation of the body so as enable removal of the insertion device past the needle after insertion into the septum of the implanted access port.

22. The insertion device as defined in claim 21, wherein the body further includes at least one cutout for enabling a user to grasp the skin surface covering the implanted access port while the insertion device is in place atop the implanted access port.

23. An insertion device for accessing an access port implanted under the skin of a patient with a needle assembly, the needle assembly including a needle extending from a hub, the insertion device comprising:

a body including;

a slit including a slit adjustment zone for adjusting a longitudinal length of the slit;

a stabilizing portion that stabilizes a position of the implanted access port when placed on the skin of the patient atop the implanted access port; and

a guide portion for guiding the needle along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port, the guide portion including a retainer component that releasably attaches to the hub, the retainer component including a projection slidably disposed within the slit to enable distal and proximal movement of the retainer component, the retainer component constraining distal and proximal movement of the needle along the predetermined path.

24. An insertion device for accessing an access port implanted under the skin of a patient with a needle assembly, the needle assembly including a needle extending from a hub and a base slidably disposed on the needle, the base removably attached to the insertion device, the insertion device comprising:

a body including;

a stabilizing portion that stabilizes a position of the implanted access port when placed on the skin of the patient atop the implanted access port, the stabilizing portion including a cavity and a slot in communication with the cavity, the slot enabling removal of the insertion device from the needle assembly following insertion of the needle into the implanted access port; and

a guide portion for guiding the needle along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port, the guide portion including a retainer component that releasably attaches to the hub, the retainer component constraining distal and proximal movement of the needle along the predetermined path.