Medical hub and method of using same

• US 9,737,699 B2
• Filed: 02/20/2015
• Issued: 08/22/2017
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: Mark A. Saab
• Original Assignee: Mark A. Saab
• Inventors: Saab, Mark A.
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US14/627,749
• Publication Number:
  US 20150190622A1
• Time in Patent Office: 914 Days
• 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. A transcutaneous component of a medical access assembly that comprises separate, connectable transcutaneous and subcutaneous components which, respectively, define transcutaneous and subcutaneous channels that, in combination, establish a complete long-term body access channel extending from a proximal location outside the skin, through the transcutaneous and subcutaneous components, to a distal internal location in a living body, the transcutaneous and subcutaneous components adapted for being subcutaneously connected at a subcutaneous connection location to join the respective transcutaneous and subcutaneous channels, wherein the transcutaneous component comprises a unibody construction that includes:

(a) a hub having at least first and second sides, and with integral skirt and tube members disposed along the first side of the hub, whereby the tube projects transcutaneously from an interior region of the hub, through the first side of the hub, to above the skin surface when the hub is implanted, and the skirt covers and seals the juncture between the first side of the hub and the tube;

(b) a hub passageway through the hub interior region providing a connection between the interior of the tube and an outlet connector at the second side of the hub, whereby a transcutaneous channel is defined that runs seriatim from outside the body, through the tube, through the hub passageway, to the outlet connector; and

,

(c) porous tissue ingrowth material that covers at least enough of the skirt and tube members to provide a substantially continuous porous tissue ingrowth surface between the skirt and the skin surface when the hub is implanted;

and further comprising;

a right-angle conduit member connected to the end of the tube that projects above the skin surface;

an extension tube with proximal and distal extension tube ends wherein the distal extension tube end is connected to the right-angle conduit member, and the proximal extension tube end is connected to a luer assembly; and

a catheter tube that runs at least through the interior of an extended transcutaneous channel defined by the components of the transcutaneous component assembly from the luer assembly at a proximal end of the extended transcutaneous channel to the outlet connector at a distal end of the extended transcutaneous channel.

2. The transcutaneous component according to claim 1 wherein the outlet connector comprises a barbed distal end sized to connect to a proximal end of the subcutaneous component.

3. The transcutaneous component according to claim 1 further comprising a collar sized to fit concentrically around the outlet connector to secure a proximal end of the subcutaneous component to the outlet connector.

4. The transcutaneous component according to claim 1 wherein the outlet connector includes an externally threaded portion with threads that engage corresponding internal threads of a lock collar such that rotation of the collar tightens a connection between a proximal end of the subcutaneous component and the outlet connector.

5. The transcutaneous component according to claim 1 wherein the outlet connector comprises a barbed distal end sized to connect to a proximal end of the subcutaneous component.

6. A medical access assembly comprising the transcutaneous component according to claim 1 connected to the subcutaneous component, wherein the outlet connector extends distally from the second side of the hub such that a channel connection location where the transcutaneous channel joins the subcutaneous channel is distal of the second side of the hub, and also wherein the longitudinal axes of the transcutaneous channel and the subcutaneous channel are substantially in alignment at the channel connection location.

7. A medical access assembly comprising the medical hub transcutaneous component according to claim 1 connected to the subcutaneous component, wherein the outlet connector projects distally from the second side of the hub such that a connection location between the transcutaneous channel and the subcutaneous component is distal of the second side of the hub, and also wherein the longitudinal axes of the transcutaneous channel and the subcutaneous component are substantially in alignment at and on either side of the connection location.

8. The transcutaneous component according to claim 1 wherein the outlet connector projects distally from the second side of the hub such that a channel connection location where the transcutaneous portion of the complete body access channel meets the subcutaneous portion of the complete body access channel is distal of the second side of the hub, and also wherein the longitudinal axes of the transcutaneous and subcutaneous portions of the complete body access channel are substantially in alignment at the channel connection location.

9. A method of using a medical access assembly, said method comprising the steps of:

(a) providing a unibody transcutaneous component of a medical access assembly that comprises separate, connectable transcutaneous and subcutaneous components which, respectively, define transcutaneous and subcutaneous channels that, in combination, establish a complete long-term body access channel extending from a proximal location outside the skin, through the transcutaneous and subcutaneous components, to a distal internal location in a living body such that a distal end of the subcutaneous component can be sited precisely at a desired treatment/diagnostic site, the transcutaneous and subcutaneous components adapted for being subcutaneously connected at a subcutaneous connection location to join the respective transcutaneous and subcutaneous channels, wherein the transcutaneous component comprises a unibody construction that includes;

(i) a hub having at least first and second sides, and with integral skirt and tube members disposed along the first side of the hub, whereby the tube projects transcutaneously from an interior region of the hub, through the first side of the hub, to above the skin surface when the hub is implanted, and the skirt covers and seals the juncture between the first side of the hub and the tube;

(ii) a hub passageway through the hub interior region providing a connection between the interior of the tube and an outlet connector at the second side of the hub, whereby a transcutaneous channel is defined that runs seriatim from outside the body, through the tube, through the hub passageway, to the outlet connector; and

,

(iii) porous tissue ingrowth material that covers at least enough of the skirt and tube members to provide a substantially continuous porous tissue ingrowth surface between the skirt and the skin surface when the hub is implanted;

(b) subcutaneously implanting the hub of the transcutaneous component such that the tube of the transcutaneous component projects transcutaneously from the first side of the hub to above the skin surface;

(c) determining a subcutaneous distance from the outlet connector of the implanted hub to a treatment/diagnostic site distal of the implanted hub;

(d) based on the subcutaneous distance determined in step (c), sizing the subcutaneous component to mate with the outlet connector when a distal end of the subcutaneous component is sited at the treatment/diagnostic site;

(e) connecting a proximal end of the subcutaneous component to the outlet connector at the subcutaneous connection location distal of the second side of the hub to form the complete body access channel; and

,

(f) accessing the treatment/diagnostic site via the body access channel, and

further wherein the body access channel is used to deliver a medical instrument to the treatment/diagnostic site.

10. The method according to claim 9 wherein the outlet connector comprises a barbed distal end sized to receive the proximal end of the subcutaneous component.

11. The method according to claim 9 wherein at least a portion of the subcutaneous component extends through a blood vessel.

12. The method according to claim 9 wherein a catheter tube that runs through the body access channel is used to deliver fluids to, or to withdraw fluids from, the treatment/diagnostic site.

13. The method according to claim 9 wherein the longitudinal axes of the transcutaneous and subcutaneous channels are substantially in alignment at the connection location.