INFUSION APPARATUSES AND RELATED METHODS

• US 20060264898A1
• Filed: 04/25/2006
• Published: 11/23/2006
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Powers, Kelly B., Weir, Steven A., Stats, Jason R., Hamatake, Bret, Evans, John G., Hibdon, Dwight, Rome, Guy T., Gerondale, Jay D., Beasley, Jim C.
• Granted Patent: US 8,545,460 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 septum A61M2039/0036
• 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

Access ports for providing subcutaneous access to a patient are disclosed. Such access ports may include: at least one structural element configured for resisting deformation of the septum in response to a pressure developed within the reservoir. Further, an access port may be structured for accommodating: 1) a flow rate of at least about 1 milliliter per second; or 2) a pressure developed within the reservoir of at least about 35 psi. An infusion set is disclosed and may be structured for flowing a fluid at a flow rate of at least about 1 milliliter per second. Infusion tubing comprising a plurality of layers is disclosed. Methods of operating and flowing a fluid through an access port or an infusion set are disclosed. A method of identifying an access port for power injection is disclosed. Septums comprising at least one gel region are disclosed.

Claims

1. A method of flowing fluid through an access port, the method comprising:

providing a vascular access port; and

flowing a fluid through the access port at a rate of at least about 1 milliliter per second.

2. The method of claim 1, wherein flowing the fluid through the access port causes a pressure of at least about 35 psi within a reservoir of the access port.

3. The method of claim 2, wherein flowing the fluid through the access port causes a pressure of between about 37 psi and 65 psi within the reservoir of the access port.

4. The method of claim 1, wherein flowing the fluid through the access port comprises flowing the fluid through the access port at a rate of between about 2 milliliters per second and about 5 milliliters per second.

5. The method of claim 1, wherein flowing the fluid through the access port comprises flowing the fluid through the access port at a rate of at least about 5 milliliters per second.

6. The method of claim 1, further comprising limiting deformation of the septum in response to the pressure developed within the reservoir.

7. The method of claim 6, wherein limiting deformation of the septum comprises reinforcing the septum against deformation with at least one structural element.

8. The method of claim 1, wherein flowing the fluid through the access port comprises using a mechanical injector to flow the fluid through an infusion set in fluid communication with the access port.

9. The method of claim 8, wherein flowing the fluid through the infusion set causes a pressure of at least about 100 psi within at least a portion of the infusion set.

10. A method of flowing fluid through an infusion set, the method comprising:

providing an infusion set for operably coupling to a vascular access port; and

flowing a fluid through the infusion set at a rate of at least about 1 milliliter per second.

11. The method of claim 10, wherein flowing the fluid through the infusion set causes a pressure of at least about 100 psi within at least a portion of the infusion set.

12. The method of claim 10, wherein flowing the fluid through the infusion set comprises flowing the fluid through the infusion set at a rate of between about 2 milliliters per second and 5 milliliters per second.

13. The method of claim 10, wherein flowing the fluid through the infusion set comprises flowing the fluid through the infusion set at a rate of at least about 5 milliliters per second.

14. An access port for providing subcutaneous access to a patient, the access port comprising:

a housing defining an aperture for capturing a septum, the housing and septum defining a reservoir, the septum including a tenon region and wherein the housing of the access port defines a complimentary mortise region structured for accepting at least a portion of the tenon region of the septum.

15. The access port of claim 14, further comprising at least one structural element configured for limiting deformation of the septum in response to a pressure developed within the reservoir.

16. The access port of claim 14, wherein the access port includes at least one feature configured for identifying a maximum flow rate through the access port.

17. The access port of claim 14, wherein the access port is configured to accommodate a flow rate of at least 1 milliliter per second of a fluid.

18. An access port for providing subcutaneous access to a patient, the access port comprising:

a housing defining an aperture for capturing a septum, the housing and septum defining a reservoir, and

wherein the housing and septum are structured for accommodating a flow rate through the reservoir of at least about 1 milliliter per second.

19. The access port of claim 18, further comprising at least one structural element configured for resisting deformation of the septum in response to a pressure developed within the reservoir.

20. The access port of claim 18, wherein the septum includes a tenon region and the housing of the access port defines a complimentary mortise region structured for accepting at least a portion of the tenon region of the septum.

21. The access port of claim of 18, wherein the port is substantially implanted in the patient, the port being configured to be identified by palpation through the patient'"'"'s skin as a port capable of power injection.

22. An access port for providing subcutaneous access to a patient, the access port comprising:

a housing defining an aperture for capturing a septum, the housing and septum defining a reservoir, and

wherein the housing and septum are structured for accommodating a pressure developed within the reservoir of at least about 35 psi.

23. The access port of claim 22, further comprising at least one structural element configured for resisting deformation of the septum in response to a pressure developed within the reservoir.

24. The access port of claim 22, wherein the septum includes a tenon region and the housing of the access port defines a complimentary mortise region structured for accepting at least a portion of the tenon region of the septum.

25. The access port of claim 22, wherein the access port includes at least one feature configured for identifying a maximum flow rate through the access port.

26. An infusion set for use in subcutaneously accessing a patient, the infusion set comprising:

a tubing section defining a lumen;

a cannula in fluid communication with the lumen of the tubing section, wherein the cannula is configured for insertion through a septum of an access port; and

wherein the tubing section and cannula are structured for flowing a fluid at a flow rate of at least about 1 milliliter per second.

27. The infusion set of claim 26, wherein the tubing section comprises a plurality of layers and wherein at least two of the plurality of layers comprise different materials.

28. The infusion set of claim 26, wherein at least one of the plurality of layers is bonded to one or more adjacent layers of the plurality of layers.

29. The infusion set of claim 26, wherein at least one layer of the plurality of layers comprises a thermoplastic polyurethane.

30. The infusion set of claim 26, wherein each of the plurality of layers comprises a different material.

31. The infusion set of claim 26, further comprising at least one reinforcement element within at least one of the plurality of layers.

32. Infusion tubing for use in accessing a vascular system of a patient, the infusion tubing comprising:

a plurality of layers; and

wherein the tubing is structured for accommodating a fluid flow rate of at least about 1 milliliter per second.

33. The infusion tubing of claim 32, wherein at least one of the plurality of layers is bonded to one or more adjacent layers of the plurality of layers.

34. The infusion tubing of claim 32, wherein at least two of the plurality of layers comprise different materials.

35. The infusion tubing of claim 32, wherein at least one of the plurality of layers is bonded to one or more adjacent layers of the plurality of layers.

36. The infusion tubing of claim 32, wherein at least one layer of the plurality of layers comprises at least one of the following:

a thermoplastic polyurethane, PEEK, Polyimide, Ultem, PTFE, FEP, Pebax, PET, or silicone.

37. The infusion tubing of claim 32, further comprising at least one reinforcement element within at least one of the plurality of layers.

38. A method of identifying an access port as being suitable for power injection, the method comprising:

providing an access port including a septum; and

identifying the access port as being suitable for power injection.

39. The method of claim 38, further comprising perceiving at least one feature of the access port;

wherein perceiving the at least one feature of the access port comprises palpating the at least one feature of the access port or visually perceiving the at least one feature of the access port.

40. The method of claim 38, wherein identifying the access port as being suitable for power injection comprises visually perceiving information provided on at least one of a key chain, a bracelet, a wrist band, a sticker provided on a patient'"'"'s chart, a patient ID card, and a label provided on packaging of the access port.

41. Infusion tubing for use in accessing a vascular system of a patient, the infusion tubing comprising:

a plurality of layers; and

wherein at least one layer of the plurality of layers extends beyond at least another of the plurality of layers and is structured for forming a cannula for puncturing a septum of an access port.

42. An access port for providing subcutaneous access to a patient, comprising:

a housing configured for capturing a septum, the septum configured for inserting a cannula therethrough into a reservoir defined within the housing; and

at least one structural element configured for resisting deformation of the septum in response to a pressure developed within the reservoir.

43. The access port of claim 42, wherein the at least one structural element extends from a lower surface of the septum to the housing.

44. The access port of claim 43, wherein the at least one structural element comprises one or more extension legs of the septum.

45. The access port of claim 42, wherein the at least one structural element extends from an upper surface of the septum to the housing.

46. The access port of claim 42, wherein the at least one structural element includes at least one barb positioned at least partially within the septum.

47. The access port of claim 42, wherein the at least one structural element extends laterally through at least a portion of the septum.

48. The access port of claim 42, wherein the at least one structural element abuts or is proximate to at least a portion an upper surface of the septum.

49. The access port of claim 42, wherein the at least one structural element forms a pattern comprising at least one of the following:

a generally triangular pattern, a generally rectangular pattern, and a plurality of substantially parallel lines.

50. The access port of claim 42, wherein the at least one structural element is at least partially embedded within the septum and forms a closed plane figure.

51. The access port of claim 42, wherein the access port comprises at least one of titanium and plastic.

52. A method of operating an access port comprising:

providing a housing configured for capturing a septum, the septum configured for inserting a cannula therethrough into a reservoir defined within the housing;

developing a pressure within the reservoir of the housing; and

limiting deformation of the septum in response to the pressure developed within the reservoir.

53. The method of claim 52, wherein limiting deformation of the septum comprises nonperipherally coupling the septum to the housing.

54. The method of claim 52, wherein limiting deformation of the septum comprises providing at least one structural element configured to limit deformation of the septum in response to the pressure developed within the reservoir.

55. The method of claim 54, wherein providing a structural element comprises providing at least one laterally extending structural element.

56. The method of claim 52, wherein developing the pressure within the reservoir of the housing comprises flowing a fluid through the reservoir at a rate of at least about 1 milliliter per second.

57. An infusion set for use in subcutaneously accessing a patient, the infusion set comprising:

a tubing section defining a lumen;

a cannula in fluid communication with the lumen of the tubing section, wherein the cannula is configured for insertion through a septum of an access port; and

wherein the tubing section and cannula are structured for accommodating a pressure of at least about 400 psi.

58. The infusion set of claim 57, wherein the tubing section comprises a plurality of layers and wherein at least two of the plurality of layers comprise different materials.

59. The infusion set of claim 58, further comprising at least one reinforcement element within at least one of the plurality of layers.

60. The infusion set of claim 57, wherein the tubing section and cannula are structured for accommodating a pressure of about 600 psi.

61. A septum for assembly with a housing to form an access port for providing subcutaneous access to a patient, the septum comprising:

a body including an upper surface and a lower surface; and

at least one gel region positioned generally between the upper surface and the lower surface.

62. The septum of claim 61, wherein the at least one gel region comprises a silicone gel or a viscous liquid.

63. The septum of claim 61, further comprising a mesh extending through the at least one gel region.

64. A septum for assembly with a housing to form an access port for providing subcutaneous access to a patient, the septum comprising:

a body;

a layer formed over at least a portion of the body;

at least one gel region disposed at least partially between the layer and the body.

65. The septum of claim 64, wherein the at least one gel region comprises a silicone gel or a viscous liquid.