Assemblies for identifying a power injectable access port

• US 10,625,065 B2
• Filed: 08/20/2018
• Issued: 04/21/2020
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Powers, Kelly B., Beasley, Jim C., Rome, Guy T.
• Primary Examiner(s): Hayman, Imani N
• Application Number:
  US16/105,725
• Publication Number:
  US 20190111243A1
• Time in Patent Office: 610 Days
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/325 Means obstructing the needle passage at distal end of a needle protection sleeve
• CPC Class Codes: A61M 2039/0009 Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
• CPC Class Codes: A61M 2039/0045 Radiopaque indicia
• CPC Class Codes: A61M 2039/0054 Multiple layers
• CPC Class Codes: A61M 2039/0063 Means for alignment of the septum, e.g. septum rim with alignment holes
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/0205 for injecting media
• 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 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61M 2039/0288 protectors, caps or covers therefor
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6054 : Magnetic identification systems
• CPC Class Codes: A61M 2205/6081 : Colour codes
• 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 5/007 : for contrast media
• 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
• CPC Class Codes: Y10T 428/139 : Open-ended, self-supporting conduit, cylinder, or tube-type article

Abstract

A method of using a power-injectable port includes obtaining the power-injectable access port, attaching a catheter to an outlet stem of the power-injectable access port, and implanting the power-injectable access port and the catheter into a patient. The method further includes identifying the power-injectable access port following the implanting, inserting a distal end of a needle through the septum and into the reservoir, and injecting contrast media through the needle at a rate of at least one milliliter per second. The power-injectable access port includes a housing, a septum, a reservoir, and an outlet stem in fluid communication with the reservoir. The power-injectable access port is rated for injection of contrast media at a flow rate of at least 1 milliliter per second. The power-injectable access port is structured for operation at a pressure in the reservoir of at least 35 psi.

Claims

1. A method of using a power-injectable access port, comprising:

obtaining the power-injectable access port,

the power-injectable access port comprising;

a housing;

a septum;

a reservoir; and

an outlet stem in fluid communication with the reservoir,

the power-injectable access port rated for injection of contrast media at a flow rate of at least 1 milliliter per second,

the power-injectable access port structured for operation at a pressure in the reservoir of at least 35 psi;

attaching a catheter to the outlet stem;

implanting the power-injectable access port and the catheter into a patient;

identifying the power-injectable access port following the implanting;

inserting a distal end of a needle through the septum and into the reservoir; and

injecting the contrast media through the needle at a rate of at least one milliliter per second.

2. The method according to claim 1, wherein the power-injectable access port further comprises a radiopaque feature, the identifying step including using X-ray to detect the radiopaque feature.

3. The method according to claim 2, wherein the radiopaque feature is provided by a radiopaque material in the septum.

4. The method according to claim 1, further comprising providing an identification feature separate from the power-injectable access port, the identifying step including visually perceiving the identification feature.

5. The method according to claim 4, wherein the injecting the contrast media includes using an infusion apparatus, and wherein the identification feature is provided on one or more components of the infusion apparatus.

6. The method according to claim 4, wherein the identification feature is provided on an element selected from the group consisting of a key chain, a bracelet, a wrist band, a sticker provided on a patient'"'"'s chart, a patient ID card, a label provided on packaging of the power-injectable access port, and combinations thereof.

7. The method according to claim 1, wherein the step of injecting the contrast media through the needle includes inducing a pressure within the reservoir in a range of about 37 psi to about 65 psi.

8. The method according to claim 1, wherein the needle is constructed to have a burst pressure of at least 100 psi.

9. The method according to claim 8, wherein the needle is constructed to have a burst pressure of at least 400 psi.

10. The method according to claim 1, wherein the power-injectable access port is rated for injection of contrast media at a flow rate of between 2 milliliters per second and 5 milliliters per second.

11. The method according to claim 1, wherein the step of identifying the power-injectable access port is performed prior to, and as a precondition for, the step of injecting the contrast media through the needle.

12. The method according to claim 11, wherein the power-injectable access port further comprises a radiopaque feature, the identifying step including using X-ray to detect the radiopaque feature.

13. The method according to claim 12, wherein the radiopaque feature is provided by a radiopaque material in the septum.

14. The method according to claim 11, further comprising providing an identification feature separate from the power-injectable access port, the identifying step including visually perceiving the identification feature.

15. The method according to claim 14, wherein the step of injecting the contrast media includes using an infusion apparatus, and wherein the identification feature is provided on one or more components of the infusion apparatus.

16. The method according to claim 14, wherein the identification feature is provided on an element selected from the group consisting of a key chain, a bracelet, a wrist band, a sticker provided on a patient'"'"'s chart, a patient ID card, a label provided on packaging of the power-injectable access port, and combinations thereof.

17. The method according to claim 11, wherein the step of injecting the contrast media through the needle includes inducing a pressure within the reservoir in a range of about 37 psi to about 65 psi.

18. The method according to claim 11, wherein the needle is constructed to have a burst pressure of at least 100 psi.

19. The method according to claim 18, wherein the needle is constructed to have a burst pressure of at least 400 psi.

20. The method according to claim 11, wherein the power-injectable access port is rated for injection of contrast media at a flow rate of between 2 milliliters per second and 5 milliliters per second.

21. The method according to claim 1, wherein as a result of the implanting step, an implanted power-injectable access port is inside of the patient, wherein the step of identifying the power-injectable access port following the implanting step comprises confirming that the implanted port is the power-injectable access port, and wherein the injecting step is performed subsequent to the confirming step.

22. The method according to claim 21, wherein the power-injectable access port further comprises a radiopaque feature, the identifying step including using X-ray to detect the radiopaque feature.

23. The method according to claim 22, wherein the radiopaque feature is provided by a radiopaque material in the septum.

24. The method according to claim 21, further comprising providing an identification feature separate from the power-injectable access port, the identifying step including visually perceiving the identification feature.

25. The method according to claim 24, wherein the step of injecting the contrast media includes using an infusion apparatus, and wherein the identification feature is provided on one or more components of the infusion apparatus.

26. The method according to claim 24, wherein the identification feature is provided on an element selected from the group consisting of a key chain, a bracelet, a wrist band, a sticker provided on a patient'"'"'s chart, a patient ID card, a label provided on packaging of the power-injectable access port, and combinations thereof.

27. The method according to claim 21, wherein the step of injecting the contrast media through the needle includes inducing a pressure within the reservoir in a range of about 37 psi to about 65 psi.

28. The method according to claim 21, wherein the needle is constructed to have a burst pressure of at least 100 psi.

29. The method according to claim 28, wherein the needle is constructed to have a burst pressure of at least 400 psi.

30. The method according to claim 21, wherein the power-injectable access port is rated for injection of contrast media at a flow rate of between 2 milliliters per second and 5 milliliters per second.

31. The method according to claim 1, wherein based on the step of identifying the power-injectable access port following the implanting step, the injecting step is performed.

32. The method according to claim 31, wherein the power-injectable access port further comprises a radiopaque feature, the identifying step including using X-ray to detect the radiopaque feature.

33. The method according to claim 32, wherein the radiopaque feature is provided by a radiopaque material in the septum.

34. The method according to claim 31, further comprising providing an identification feature separate from the power-injectable access port, the identifying step including visually perceiving the identification feature.

35. The method according to claim 34, wherein the step of injecting the contrast media includes using an infusion apparatus, and wherein the identification feature is provided on one or more components of the infusion apparatus.

36. The method according to claim 34, wherein the identification feature is provided on an element selected from the group consisting of a key chain, a bracelet, a wrist band, a sticker provided on a patient'"'"'s chart, a patient ID card, a label provided on packaging of the power-injectable access port, and combinations thereof.

37. The method according to claim 31, wherein the step of injecting the contrast media through the needle includes inducing a pressure within the reservoir in a range of about 37 psi to about 65 psi.

38. The method according to claim 31, wherein the needle is constructed to have a burst pressure of at least 100 psi.

39. The method according to claim 38, wherein the needle is constructed to have a burst pressure of at least 400 psi.

40. The method according to claim 31, wherein the power-injectable access port is rated for injection of contrast media at a flow rate of between 2 milliliters per second and 5 milliliters per second.