Percutaneous access device

• US 4,897,081 A
• Filed: 02/17/1987
• Issued: 01/30/1990
• Est. Priority Date: 05/25/1984
• Status: Expired due to Fees

• Current Assignee: TMCA Foundation Incorporated
• Original Assignee: Thermedics, Inc. (Thermo Fisher Scientific Incorporated), TMCA Foundation Incorporated
• Inventors: Poirier, Victor L., Daly, Benedict D. T., Clay, Warren C.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/015,588
• Time in Patent Office: 1,078 Days
• Field of Search: 604/175-180, 604/95, 128/DIG. 26
• US Class Current: 604/175
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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 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: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10S 128/26 Cannula supporters

Abstract

Disclosed is a percutaneous access device (PAD) for long-term skin penetration and use as an access port in the body of a patient. The buttonlike device includes a flat skirt for subdermal anchoring of the PAD and a neck through which a tube may extend for transmission of materials to or from the body. A two-stage porous bed covering the skirt and at least a portion of the neck promotes formation of a tight, infection-free barrier between the percutaneous access device and adjacent tissues, stabilizing the device for long-term use. The first stage of the bed retards downgrowth of epidermal cells for a time sufficient for mature collagen to form in the second stage, thereby permitting the tight dermal/biomaterial interface or barrier to form at a location near the junction of the two stages.

Claims

1. In a percutaneous access deice including a button having a skirt and a neck integral with and substantially normal to said skirt, said neck and skirt being formed of a semirigid biocompatible material and having a bore therethrough to accommodate a tube, and a porous bed overlying and attached to at least a portion of said button, the improvement wherein said porous bed comprises a first stage extending along a portion of said skirt adjacent to said neck and along at least the lower portion of said neck and a second stage formed essentially of a biocompatible material and having pores of a size in the range of about 400-800 microns, said first stage having a total length along said neck and said skirt of at least 0.25 inches and being fabricated of layers of filaments of a diameter in the range of about 0.0004 to 0.015 inches and of a polyurethane material which is the reaction product of dicyclohexyl methane diisocyanate, polytetramethylene ether glycol, and 1,4 butane diol, said layers being formed into a structure having pores of a size in the range of about 50-125 microns, said percutaneous access device, upon implantation of the skirt in subcutaneous tissue adjacent to the dermis, promoting formation of a stable, tight, infection-free biologic seal between said device and adjoining tissue through the downgrowth of epidermal cells through the first stage and the formation of mature collagen in said second stage.

2. A percutaneous access device as in claim 1 wherein said second stage comprises layers of filaments of a polyurethane material formed as the reaction product of dicylohexyl methane diisocyanate, polytetramethylene ether glycol, and 1,4 butane diol.

3. A percutaneous access device implantable in humans for periods of up to a year or longer to permit access to the body through the skin comprising:

a main body including a substantially flat, disk-shaped skirt and a neck integral with and substantially normal to said skirt, said neck and skirt formed of a biocompatible polyurethane and including a bore therethrough to accommodate a tube;

to a lower

a first porous bed surrounding and attached portion of said neck and extending along a portion of the upper surface of said skirt adjacent to said neck, said first porous bed being formed of a polyurethane material which is the reaction product of dicyclohexyl methane diisocyanate, polytetramethylene ether glycol, and 1,4 butane diol and including a multiplicity of interconnected pores having a size in the range of about 50-125 microns so that upon implantation of the skirt just below the dermis, said pores permit downgrowth of epidermal cells through said bed at a controlled rate substantially without allowing wicking of body fluids upward to a point external to the body; and

a second porous bed forming a junction on said skirt with one end of said first bed, said second porous bed attached to and covering the portion of the skirt not overlain by said first bed and including pores of a size in the range of about 400-800 microns so as to permit infiltration of fibroblasts and formation of collagen in said pores;

said beds promoting the formation of a stable, tight, infection-free biologic seal between said beds and adjoining tissue.