Medical device with adjustable tissue ingrowth cuff

• US 20110125129A1
• Filed: 10/07/2010
• Published: 05/26/2011
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: Mark A. Saab
• Original Assignee: Mark A. Saab
• Inventors: Saab, Mark A.
• Granted Patent: US 8,979,806 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• 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

Abstract

Methods and apparatus are disclosed for making and using adjustable epidermal tissue ingrowth cuff and catheter assemblies for transcutaneous placement to provide periodic or continuous external access for medical purposes to an interior body region of a patent who requires such medical treatment over an extended period of time.

Claims

1-55. -55. (canceled)

56. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet, further wherein said second hub wall portion is substantially perpendicular to the plane of the epidermal face;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(c) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter.

57. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected-to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a flange member adjacent to said epidermal face, said flange member having a central bore which is axially aligned with the epidermal face inlet, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(c) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter.

58. An apparatus according to claim 57 further comprising a hollow flange tube extending through the central bore of the flange member and the epidermal face inlet, said flange tube being bonded along its inner wall to the outer wall of a transcutaneous portion of said channel.

59. An apparatus according to claim 58 further wherein said flange member and flange tube consist essentially of a material which is compatible with the epidermis.

60. An apparatus according to claim 58 wherein at least the external surfaces of said flange member and flange tube comprise porous surfaces which promote tissue ingrowth on and around these surfaces.

61. An apparatus according to claim 60 wherein said porous surfaces comprise surface pores ranging in size between about 20-2000 microns.

62. An apparatus according to claim 58 further wherein said flange member and flange tube consist essentially of polyester.

63. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(c) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter;

further wherein at least a surface of the apparatus is treated to reduce the formation of thrombus on the apparatus.

64. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(c) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter, wherein said hub outlet connector fitting comprises a barbed distal end which is sized to receive the proximal end of the subcutaneous catheter; and

(d) a collar sized to fit concentrically around said hub outlet connector fitting in order to secure the proximal end of the subcutaneous catheter in the annular region-between said hub pullet connector fitting and said collar.

65. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(c) a hub outlet connector fitting at the distal end of said channel, further wherein the proximal end of said hub outlet connector fitting comprises external threads, to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter, wherein said hub outlet connector fitting comprises a barbed distal end which is sized to receive the proximal end of the subcutaneous catheter.

66. An apparatus according to claim 65 further comprising a collar sized to fit concentrically around said hub outlet connector fitting, said collar having internal threads at its proximal end sized to mate with the external threads of the hub outlet connector fitting.

67. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) an integral tube and skirt member, the tube portion being sized to fit through said epidermal face inlet and surround the outer wall of a transcutaneous portion of said channel while the skirt portion is sized to cover and seal an annular region between the outer wall of the tube portion and the perimeter of the epidermal face inlet;

(c) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(d) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter.

68. An apparatus according to claim 67 further wherein said integral tube and skirt member consists essentially of a material which is compatible with the epidermis and promotes tissue ingrowth.

69. An apparatus according to claim 67 further wherein at least the external surfaces of said integral tube and skirt member comprise porous surfaces which promote tissue ingrowth on and around these surfaces.

70. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, further comprising an epidermal face connector fitting projecting outwardly from said epidermal face and having a barbed end, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the-hub outlet;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted; and

,

(c) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter.

71. An apparatus according to claim 70 wherein a portion of said channel comprises a conduit assembly wherein a hollow tube portion of the assembly is sized to mate with a well section formed along the first hub wall portion and a conduit housed inside the tube portion is sized to engage the barbed end of the epidermal face connector fitting when the tube portion is mated into the well section.

72. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, _Ind into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet when said hub component is implanted, further wherein a portion of said channel comprises a conduit assembly which is joined to the hub component at the epidermal face; and

,

(c) a hub outlet connector fitting at the distal end of said channel to provide a connection to the trimmed-to-size proximal end of an implanted subcutaneous catheter.

73. An apparatus according to claim 72 wherein said conduit assembly is separately formed and is bonded to the epidermal face.

74. An apparatus according to claim 72 wherein said conduit assembly and said hub component are formed as a unitary construction.

75. An apparatus according to claim 72 wherein said conduit assembly further comprises a luer assembly.

76. An apparatus according to claim 72 wherein said conduit assembly further comprises a right-angle section.

77. A method for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to a proximal end of an implanted subcutaneous catheter after the proximal end is trimmed to size such that the distal tip of the subcutaneous catheter can be sited precisely at a desired internal body location, said method comprising the steps of:

(a) subcutaneously implanting a fluid connection assembly comprising a hub component having an epidermal face along the exterior of a first hub wall portion, an epidermal face inlet in said epidermal face extending into a hub interior region, a hub outlet from said hub interior region along a second hub wall portion, further wherein said second hub wall portion is substantially perpendicular to the plane of the epidermal face, and a hub passageway through the hub interior extending between the epidermal face inlet and the hub outlet;

(b) determining the distance from said hub outlet to the desired internal body location;

(c) providing at least a channel running seriatim from outside the body, through the epidermis, through said epidermal face inlet, and through said hub interior to said hub outlet and a hub outlet connector fitting at the distal end of said channel to provide a connection to a proximal end of an implanted subcutaneous catheter;

(d) trimming the proximal length of said subcutaneous catheter as needed to mate the proximal end of said catheter to said hub outlet connector fitting when the distal tip of said catheter is sited at the desired internal body location; and

,

(e) connecting the proximal end of said subcutaneous catheter to said hub outlet connector fitting.

78. A method according to claim 77 further wherein said epidermal face comprises a porous surface which promotes tissue ingrowth on said epidermal face.

79. A method according to claim 77 wherein said fluid connection assembly further comprises a flange member adjacent to said epidermal face, said flange member having a central bore which is axially aligned with the epidermal face inlet.

80. A method according to claim 79 wherein said fluid connection assembly further comprises a hollow flange tube extending through the central bore of the flange member and the epidermal face inlet, said flange tube being bonded along its inner wall to the outer wall of a transcutaneous portion of said channel.

81. A method according to claim 80 further wherein said flange member and flange tube consist essentially of a material which is compatible with the epidermis.

82. A method according to claim 81 wherein at least the external surfaces of said flange member and flange tube comprise porous surfaces which promote tissue ingrowth on and around these surfaces.

83. A method according to claim 82 wherein said porous surfaces comprise surface pores ranging in size between about 20-2000 microns.

84. A method according to claim 80 further wherein said flange member and flange tube consist essentially of polyester.

85. A method according to claim 77 further comprising the step of treating at least a surface of the fluid connection assembly to reduce the formation of thrombus on the assembly.

86. A method according to claim 77 further comprising the step of treating at least a surface of the fluid connection assembly to reduce microorganisms.

87. A method according to claim 77 wherein said hub outlet connector fitting comprises a barbed distal end which is sized to receive the proximal end of the subcutaneous catheter.

88. A method according to claim 87 further wherein said hub outlet connector fitting is slidably mounted in a slot in said second wall portion.

89. A method according to claim 87 further wherein said hub outlet connector fitting is fixed to said second wall portion.

90. A method according to claim 87 further comprising the step of sliding the proximal end of the subcutaneous catheter over the barbed distal end of the hub outlet connector fitting.

91. A method according to claim 90 further wherein the proximal end of said hub outlet connector fitting comprises external hub outlet threads.

92. A method according to claim 91 further comprising the steps of:

sliding a collar sized to just fit concentrically around the proximal end of the subcutaneous catheter, said collar having internal collar threads at its proximal end sized to mate with the external hub outlet threads of the hub outlet connector fitting, in a distal direction over the proximal end of the subcutaneous catheter prior to connecting the proximal end of the subcutaneous catheter over the barbed distal end of hub outlet connector fitting;

connecting the subcutaneous catheter to the hub outlet connector fitting;

sliding the collar in a proximal direction along the subcutaneous catheter until the collar threads engage the hub outlet threads with the proximal end of the subcutaneous catheter in the annular region between the hub outlet connector fitting and the collar; and

, rotating the collar so as to thread the collar threads onto the hub outlet threads to establish a fluid-tight connection between the channel and the subcutaneous catheter.

93. A method according to claim 92 wherein said hub outlet connector fitting is slidably mounted in a slot in said second wall portion, said method further comprising the steps of:

adjusting the position of the hub outlet connector fitting along said slot such that said channel is substantially perpendicularly aligned relative to the epidermal face inlet; and

, threading said collar threads onto the hub outlet threads so as to lock the hub outlet connector fitting in place along the slot with no freedom to rotate or translate along the slot.

94. A method according to claim 77 wherein said fluid connection assembly further comprises an integral tube and skirt member, the tube portion being sized to fit through said epidermal face inlet and surround the outer wall of a transcutaneous portion of said channel while the skirt portion is sized to cover and seal an annular region between the outer wall of the tube portion and the perimeter of the epidermal face inlet.

95. A method according to claim 94 further wherein said integral tube and skirt member consists essentially of a material which is compatible with the epidermis and promotes tissue ingrowth.

96. A method according to claim 94 further wherein at least the external surfaces of said integral tube and skirt member comprise porous surfaces which promote tissue ingrowth on and around these surfaces.

97. A method according to claim 77 wherein said fluid connection assembly further comprises an epidermal face connector fitting projecting outwardly from said epidermal face and having a barbed end.

98. A method according to claim 97 wherein a portion of said channel comprises a conduit assembly wherein a hollow tube portion of the conduit assembly is sized to mate with a well section formed along the first hub wall portion and a conduit housed inside the tube portion is sized to engage the barbed end of the epidermal face connector fitting when the tube portion is mated into the well section.

99. A method according to claim 77 wherein a portion of said channel comprises a conduit assembly which is joined to the hub component at the epidermal face.

100. A method according to claim 99 further comprising the steps of:

forming the conduit assembly separately from the fluid connection assembly; and

, bonding the fluid connection assembly at its distal end to the epidermal face.

101. A method according to claim 99 further comprising the step of forming said conduit assembly and said fluid connection assembly as a unitary construction.

102. A method according to claim 99 wherein said conduit assembly further comprises a luer assembly.

103. A method according to claim 99 wherein said conduit assembly further comprises a right-angle section.