Tunneled catheter with hemostasis mechanism

• US 9,308,351 B2
• Filed: 04/02/2014
• Issued: 04/12/2016
• Est. Priority Date: 05/28/2013
• Status: Active Grant

• Current Assignee: SMH Device Corp.
• Original Assignee: SMH Device Corp.
• Inventors: Honig, Shaun M.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Carpenter, William
• Application Number:
  US14/242,996
• Publication Number:
  US 20140358076A1
• Time in Patent Office: 741 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• 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 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A hemostasis component for an invasive medical device has an inflatable cylinder affixed to the medical device at a location aligned with an ingress point of a patient. An inflation source is in fluid communication with the inflatable cylinder and a flow control valve that is effective to regulate the flow of fluid from the inflation source to the inflatable cylinder is provided. The flexible cylinder is located on the proximal end of a tunneling catheter, where it exits the skin. A thin tube is provided to inflate the flexible cylinder. In the event of bleeding, the flexible cylinder is inflated for as long as is needed to achieve hemostasis, without having to place sutures. Inflation is a simple procedure that can be done by the patient, as opposed to having to place a suture, which must be performed by a physician or a physician'"'"'s delegate, under sterile conditions.

Claims

1. A tunneled catheter comprising:

a catheter for long term hemodialysis having a distal end and a proximal end, wherein an anchoring cuff and a hemostasis component are disposed on the proximal end;

a tunneling device affixed to a distal end of the catheter;

the hemostasis component is an inflatable, double cylinder disposed proximally and distally of the anchoring cuff and both cylinders are inflatable by a same inflation tube; and

said inflation tube connecting an inflation source with said hemostasis component and a flow control valve regulates flow of a fluid from said inflation source to said hemostasis component.

2. The tunneled catheter of claim 1 wherein a chemical compound is in a mixture with said fluid and said hemostasis component is porous to said mixture.

3. The tunneled catheter of claim 2 wherein said chemical compound is selected from the group consisting of thrombin, D-glucosamine-enriched fibers, bone wax, ostene, a ferric subsulfate solution, silver nitrate, aluminum chloride, mineral zeolite, gelatin, microfibrillar collagen, poly-N-acetyl glucosamine, kaolinite, a mixture of potassium ferrate salt and a hydrophilic polymer, epinephrine and fibrin sealant.

4. The tunneled catheter of claim 3 wherein said hemostasis component is formed from a flexible biocompatible material.

5. The tunneled catheter of claim 4 wherein said flexible biocompatible material is selected from the group consisting of silicone, polyethylene terephthalate and nylon.