Medical access port, systems and methods of use thereof

• US 10,369,345 B2
• Filed: 03/31/2015
• Issued: 08/06/2019
• Est. Priority Date: 03/31/2014
• Status: Active Grant

• Current Assignee: Versago Vascular Access, Inc.
• Original Assignee: Versago Vascular Access, Inc.
• Inventors: Tallarida, Steven J., Rodgers, Richard P., Butziger, John M.
• Primary Examiner(s): Farrar, Lauren P
• Application Number:
  US15/300,625
• Publication Number:
  US 20170182303A1
• Time in Patent Office: 1,589 Days
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2039/0235 having an additional inlet, e.g. for a guidewire or a catheter tube
• CPC Class Codes: A61M 2205/04 implanted
• 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 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• 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

A medical device comprising a subcutaneous access port having an access port body and at least one needle having a removable needle tip and a needle shaft defining a needle lumen; the at least one needle housed within the access port body, the at least one needle extendable and retractable relative to the access port body; and a needle shift mechanism operable such that the at least one needle is extendable from and retractable into the access port body at a plurality of positions of the access port body.

Claims

1. A method of treating a subject, comprising:

penetrating a first needle outwardly through skin of the subject from within the subject from a first needle first use position of an access port implanted within the subject such that the first needle is exposed outside the subject,

wherein the access port comprises an access port body containing the first needle and a needle shift mechanism, the needle shift mechanism movable within the access port body to move the at least one needle to a plurality of different use positions of the access port body, wherein the needle shift mechanism is rotatable around an axis of rotation, and the at least one needle is extendable and retractable along the axis of rotation; and

wherein penetrating the first needle outwardly through skin of the subject is performed while extending the at least one needle along the axis of rotation;

introducing a first fluid into the subject through the first needle;

withdrawing the first needle inwardly through the skin of the subject from outside the subject such that the first needle is concealed within the subject and within the access port body, wherein withdrawing the first needle inwardly though the skin of the subject is performed while retracting the at least one needle along the axis of rotation;

moving the first needle within the access port body from the first needle first use position to a first needle second use position by rotating the needle shift mechanism around the axis of rotation;

penetrating the first needle outwardly through the skin of the subject from within the subject from the first needle second use position of the access port implanted within the subject such that the first needle is exposed outside the subject, wherein penetrating the first needle outwardly through skin of the subject is performed while extending the at least one needle along the axis of rotation;

introducing a second fluid into the subject through the first needle and;

withdrawing the first needle inwardly through the skin of the subject from outside the subject such that the first needle is concealed within the subject and within the access port body,

wherein withdrawing the first needle inwardly though the skin of the subject is performed while retracting the at least one needle along the axis of rotation.

2. The method claim 1 wherein:

the first needle comprises a first needle removable needle tip and a first needle shaft, and

wherein the first needle removable needle tip is removably secured to the first needle shaft, and

wherein the first needle removable needle tip closes a lumen of the first needle shaft to passage of fluid when secured to the first needle shaft; and

further comprising

penetrating the first needle outwardly through the skin of the subject from within the subject from the first needle first use position of the access port implanted within the subject such that the first needle removable needle tip is exposed outside the subject.

3. The method claim 2 further comprising:

removing the first needle removable needle tip from the first needle shaft to access the lumen of the first needle shaft before introducing the first fluid into the subject through the first needle.

4. The method claim 3 further comprising:

replacing the first needle removable needle tip on the first needle shaft after introducing the first fluid into the subject through the first needle.

5. The method claim 4 wherein:

the first needle removable needle tip is replaced on the first needle shaft with the same removable needle tip removed from the shaft.

6. The method claim 4 wherein:

the first needle removable needle tip is replaced on the first needle shaft with a sterilized removable needle tip.

7. The method claim 4 further comprising:

penetrating the first needle outwardly through the skin of the subject from within the subject from the first needle second use position of the access port implanted within the subject such that the first needle removable needle tip is exposed outside the subject.

8. The method claim 7 further comprising:

removing the first needle removable needle tip from the first needle shaft to access the lumen of the first needle shaft before introducing the second fluid into the subject through the first needle.

9. The method claim 8 further comprising:

replacing the first needle removable needle tip on the first needle shaft after introducing the second fluid into the subject through the first needle.

10. The method claim 9 wherein:

the first needle removable needle tip is replaced on the first needle shaft with the same removable needle tip removed from the shaft.

11. The method claim 9 wherein:

the first needle removable needle tip is replaced on the first needle shaft with a sterilized removable needle tip.

12. The method claim 1 further comprising:

moving the first needle within the access port body from the first needle second use position to a first needle third use position.

13. A method of treating a subject, comprising:

penetrating a first needle outwardly through skin of the subject from within the subject from a first needle first use position of an access port implanted within the subject such that the first needle is exposed outside the subject,

wherein the access port comprises an access port body containing the first needle and a needle shift mechanism, the needle shift mechanism movable within the access port body to move the at least one needle to a plurality of different use positions of the access port body, wherein the needle shift mechanism is rotatable around an axis of rotation, and the at least one needle is extendable and retractable along the axis of rotation; and

wherein penetrating the first needle outwardly through skin of the subject is performed while extending the at least one needle along the axis of rotation;

removing a first fluid from the subject through the first needle;

withdrawing the first needle inwardly through the skin of the subject from outside the subject such that the first needle is concealed within the subject and within the access port body, wherein withdrawing the first needle inwardly though the skin of the subject is performed while retracting the at least one needle along the axis of rotation;

moving the first needle within the access port body from the first needle first use position to a first needle second use position by rotating the needle shift mechanism around the axis of rotation;

penetrating the first needle outwardly through the skin of the subject from within the subject from the first needle second use position of the access port implanted within the subject such that the first needle is exposed outside the subject, wherein penetrating the first needle outwardly through skin of the subject is performed while extending the at least one needle along the axis of rotation;

removing a second fluid from the subject through the first needle and;

withdrawing the first needle inwardly through the skin of the subject from outside the subject such that the first needle is concealed within the subject and within the access port body, wherein withdrawing the first needle inwardly though the skin of the subject is performed while retracting the at least one needle along the axis of rotation.

14. The method claim 13 wherein:

the first needle comprises a first needle removable needle tip and a first needle shaft, and

wherein the first needle removable needle tip is removably secured to the first needle shaft, and

wherein the first needle removable needle tip closes a lumen of the first needle shaft to passage of fluid when secured to the first needle shaft; and

further comprising

penetrating the first needle outwardly through the skin of the subject from within the subject from the first needle first use position of the access port implanted within the subject such that the first needle removable needle tip is exposed outside the subject.

15. The method claim 14 further comprising:

removing the first needle removable needle tip from the first needle shaft to access the lumen of the first needle shaft before removing the first fluid from the subject through the first needle.

16. The method claim 15 further comprising:

replacing the first needle removable needle tip on the first needle shaft after removing the first fluid from the subject through the first needle.

17. The method claim 16 wherein:

the first needle removable needle tip is replaced on the first needle shaft with the same removable needle tip removed from the shaft.

18. The method claim 16 wherein:

the first needle removable needle tip is replaced on the first needle shaft with a sterilized removable needle tip.

19. The method claim 16 further comprising:

penetrating the first needle outwardly through the skin of the subject from within the subject from the first needle second use position of the access port implanted within the subject such that the first needle removable needle tip is exposed outside the subject.

20. The method claim 19 further comprising:

removing the first needle removable needle tip from the first needle shaft to access the lumen of the first needle shaft before removing the second fluid from the subject through the first needle.

21. The method claim 20 further comprising:

replacing the first needle removable needle tip on the first needle shaft after removing the second fluid from the subject through the first needle.

22. The method claim 21 wherein:

the first needle removable needle tip is replaced on the first needle shaft with the same removable needle tip removed from the shaft.

23. The method claim 21 wherein:

the first needle removable needle tip is replaced on the first needle shaft with a sterilized removable needle tip.

24. The method claim 13 further comprising:

moving the first needle within the access port body from the first needle second use position to a first needle third use position.