Surgical skin incision device, percutaneous infection control kit and methods of use

• US 4,955,890 A
• Filed: 12/30/1987
• Issued: 09/11/1990
• Est. Priority Date: 01/16/1986
• Status: Expired due to Term

• Current Assignee: Vitaphore Corporation
• Original Assignee: Vitaphore Corporation
• Inventors: Yamamoto, Ronald K., Conston, Stanley R.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/139,505
• Time in Patent Office: 986 Days
• Field of Search: 128/305, 128/303 R, 128/311, 128/313, 128/309, 128/306, 606/108, 606/167, 604/175
• US Class Current: 606/108
• CPC Class Codes: A61B 17/32093 for skin incisions

Abstract

A surgical cutter device for producing a skin incision of controlled length and depth at a guidewire skin puncture location is described. The cutter is particularly useful for making incisions for the insertion of catheters. In addition, there is described a device which takes full advantage of such precisely formed skin incisions, comprising a subcutaneous cuff for sealing the entrance incision for a catheter and providing antimicrobial action at the sealed entrance, and an introducer for inserting the cuff subcutaneously along the associated catheter. A preferred method for using the cutter, cuff and introducer is also described.

Claims

1. An antimicrobial cuff and introducer device for depositing the cuff subcutaneously along a catheter at a guidewire puncture location, comprising:

(A) an anti-bacterial cuff assembly comprising (a) an anti-bacterial cuff formed of a generally tubular bio-degradable collagen matrix containing an antimicrobial agent and (b) an inner tube or sleeve of silicone elastomer material slidably supporting the antimicrobial cuff and having an inner diameter selected for applying radial compression to a catheter of selected size when inserted therein; and

(B) a cuff introducer comprising (a) a generally flat, generally rectangular handle having a groove along one edge thereof for releasably threading a guidewire and selected catheter therethrough; and

(b) an introducer tube extending from the handle and having (1) a bore therethrough aligned with and communicating with the groove for receiving a guidewire and selected catheter, and (2) an outer diameter selected for releasably mounting the antimicrobial cuff assembly thereon;

(C) whereby (a) threading a catheter through the groove and introducer tube and antimicrobial cuff assembly;

(b) threading the catheter, introducer tube and antimicrobial cuff assembly along the guidewire and placing the antimicrobial cuff subcutaneously and (c) retracting the introducer leaves the antimicrobial cuff assembly in place on the catheter, allowing tissue in-growth into the antimicrobial cuff, and (d) subsequent removal of the catheter removes the inner tube therewith.

2. A device according to claim 1 wherein said cuff has tissue in-growth properties.

3. A kit comprising an antimicrobial cuff and components for making a skin incision and subcutaneously inserting a catheter and said antimicrobial cuff along said catheter through said incision, comprising:

(A) a cutter device for making skin incisions at a guidewire puncture location, comprising;

(a) a generally flat rectangular handle having a front edge;

(b) a tapered introducer tube mounted to and extending forwardly from the front edge of the handle, the introducer tube having a front end and tapering to a smaller outer diameter at the front end;

(c) a longitudinal hole extending through the handle and introducer tube and having an inner diameter selected for providing a close slidable fit over a guidewire to maintain precise alignment of the cutter device on the guidewire; and

(d) at least a single blade mounted along the side of the tube, the blade (1) abutting the front edge of the handle so that the front edge acts as a stop to selectively limit the depth of cut provided by the cutter device, (2) terminating at a point spaced rearwardly of the front end of the introducer tube and (3) having a generally forward facing cutting edge extending generally radially relative to said tube and being of a selected width for providing a cut sized to closely receive a catheter and cuff inserted into the skin along the guidewire;

(B) an antimicrobial cuff assembly comprising (a) an anti-bacterial cuff formed of a generally tubular bio-degradable collagen matrix containing an antimicrobial agent and (b) an inner tube or sleeve of silicone elastomer material adhered to and supporting the antimicrobial cuff and having an inner diameter selected for applying radial compression to a catheter of selected size when inserted therein; and

(C) a cuff introducer comprising (a) a generally flat, generally rectangular handle having a groove along one edge thereof for releasably threading a guidewire and selected catheter therethrough; and

(b) an introducer tube extending from the handle and having (1) a bore therethrough aligned with and communicating with the groove for receiving a guidewire and selected catheter, and (2) an outer diameter selected for releasably mounting the antimicrobial cuff assembly thereon;

(C) whereby (a) threading a catheter through the groove and introducer tube and antimicrobial cuff assembly;

(b) threading the catheter, introducer tube and antimicrobial cuff assembly along the guidewire and placing the antimicrobial cuff subcutaneously and (c) retracting the introducer leaves the antimicrobial cuff assembly in place on the catheter, allowing tissue in-growth into the antimicrobial cuff, and (d) subsequent removal of the catheter removes the inner tube therewith.

4. A kit according to claim 3 wherein said cuff has tissue in-growth properties.

5. A method for placing an antimicrobial, sealing cuff subcutaneously on a catheter along a guidewire comprising:

providing (A) a cutter device for making skin incisions at a guidewire puncture location, comprising;

(a) a generally flat handle having a front edge or hilt;

(b) a tapered introducer tube mounted to and extending forwardly from the front edge of the handle, the introducer tube having a front end and tapering to a relatively small size at the front end;

(c) a longitudinal hole extending through the handle and introducer tube and having an inner diameter selected for providing a close slidable fit over a guidewire to maintain precise alignment of the cutter device on the guidewire; and

(d) at least a single blade mounted along the side of the tube, the blade (1) abutting the front edge of the handle so that the front edge acts as a stop to selectively limit the depth of cut provided by the cutter device, (2) terminating at a point spaced rearwardly of the front end of the introducer tube and (3) having a generally forward facing cutting edge extending generally radially relative to said tube and being of a selected width for providing a cut sized to closely receive a device such as a catheter or anti-bacterial cuff inserted into the skin along the guidewire;

threading the cutter over the guidewire and advancing the cuter against the skin thereby producing an incision of depth predetermined by the position of the hilt relative to the blade and length predetermined by the width of the blade, then withdrawing the cutter over the guidewire;

providing an antimicrobial cuff and introducer device for depositing the cuff subcutaneously along the catheter at the guidewire puncture location, comprising (B) an anti-bacterial cuff assembly comprising (a) an anti-bacterial cuff formed of a generally tubular bio-degradable collagen matrix containing an antimicrobial agent and (b) an inner tube or sleeve of silicone elastomer material slidably supporting the antimicrobial cuff and having an inner diameter selected for applying radial compression to a catheter of selected size when inserted therein; and

(C) a cuff introducer comprising (a) a generally flat, generally rectangular handle having a groove along one edge thereof for releasably threading a guidewire and selected catheter therethrough; and

(b) an introducer tube extending rom the handle and having (1) a bore therethrough aligned with and communicating with the groove for receiving a guidewire and selected catheter, and (2) an outer diameter selected for releasably mounting the antimicrobial cuff assembly thereon;

threading a catheter of selected size through the introducer groove and tube and cuff assembly, leaving the introducer above the skin entry point and advancing the catheter over the wire and through the introducer subcutaneously; and

advancing the cuff assembly subcutaneously to position the antimicrobial cuff beneath the skin.

6. The method of claim 5, further comprising the step of separating the introducer from the catheter and cuff by pivoting the catheter and introducer away from one another and withdrawing the introducer from the catheter and cuff.

7. A method according to claim 5 or 6 wherein said cuff has tissue in-growth properties.