Tunneler and method for implanting subcutaneous vascular access grafts

• US 5,306,240 A
• Filed: 01/21/1993
• Issued: 04/26/1994
• Est. Priority Date: 01/21/1993
• Status: Expired due to Term

• Current Assignee: Technology Holding Company II (Teleflex Incorporated)
• Original Assignee: Pilling Co.
• Inventors: Berry, William
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US08/007,245
• Time in Patent Office: 460 Days
• Field of Search: 606/108, 606/167, 606/185, 604/4, 604/8, 604/49, 604/51, 604/52, 604/53, 604/164, 604/170, 604/264, 604/272, 604/274
• US Class Current: 604/507
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/0905 extendable, e.g. mechanisms for extension

Abstract

An improved tunneler for placement of an arteriovenous graft in subcutaneous tissue of a patient, includes a shaft with opposite ends carrying a penetrating tip and a handle. The shaft is manually bendable but has sufficient rigidity for retaining a desired curvature when in use. The tip and handle are interchangeable. In implanting a graft, the shaft is passed through an incision near the distal end of a patient'"'"'s limb to a proximal incision, to form a first tunnel. With the shaft in place in the tunnel, the tip and handle are interchanged, and a graft is attached to the tip and pulled toward the proximal incision until its end is exposed. A second tunnel is then formed, again by passing the instrument through the distal incision toward the proximal incision. The tip and handle are again interchanged, and, with the tip attached to the other end of the graft, the graft is pulled into place to form a loop.

Claims

1. A method of implanting a subcutaneous graft for vascular access comprising the steps of:

forming a subcutaneous tunnel by pushing a tunnelling instrument, comprising a rod having a tunnelling tip at one end and a handle at its other end, through a first incision until said one end of the rod projects through a second incision remote from said first incision and said other end of the rod projects outwardly from the first incision;

removing the handle from said other end of the rod and attaching said handle to said one end of the rod;

attaching an end of the graft to the rod with said end of the graft being adjacent to said other end of the rod; and

pulling the graft through said subcutaneous tunnel, by moving the rod through said tunnel, in the direction from said first incision toward said second incision.

2. The method according to claim 1 further comprising the steps of:

removing the tunnelling tip from said one end of the rod;

attaching the tunneling tip to the other end of the rod in place of said handle; and

attaching said one end of the graft to said tunnelling tip.

3. The method according to claim 1 wherein, in said pulling step, the graft is moved through said tunnel until said one end of the graft projects from said second incision.

4. A method of implanting a subcutaneous, arterio-venous graft for vascular access comprising the steps of:

forming a first subcutaneous tunnel by pushing a tunnelling instrument, comprising a rod having a tunnelling tip at one end and a handle at its other end, through an incision adjacent to a patient'"'"'s hand toward the patient'"'"'s elbow until said one end of the rod projects through an incision near the patient'"'"'s elbow and said other end of the rod projects outwardly from the incision near the patient'"'"'s hand;

removing the tunnelling tip and handle from the rod, connecting the tunnelling tip to said other end of the rod and connecting the handle to said one end of the rod, whereby the positions of the handle and tip on said rod are interchanged;

attaching the graft to the tunnelling tip;

pulling the graft through said first subcutaneous tunnel, by moving the rod through said tunnel in the direction from the patient'"'"'s hand toward the patient'"'"'s elbow, until one end of the graft projects through said incision near the patient'"'"'s elbow and a length of the graft, having a free end, extends from said incision near the patient'"'"'s hand;

forming a second subcutaneous tunnel by pushing a tunnelling instrument, comprising a rod having a tunnelling tip at one end and a handle at its other end, with the tunnelling tip attached to the leading end thereof and the handle attached to the trailing end thereof, through said incision adjacent to the patient'"'"'s hand toward the patient'"'"'s elbow until said leading end projects through an incision near the patient'"'"'s elbow;

removing the tunnelling tip and handle from the last-mentioned rod and interchanging the positions of the handle and tip on the last-mentioned rod;

attaching said free end of the portion of said length of the graft to the tunnelling tip on the last-mentioned rod;

pulling said graft through said second subcutaneous tunnel, by moving the last-mentioned rod through said second tunnel in the direction from the patient'"'"'s hand toward the patient'"'"'s elbow, until said free end of the graft projects through the last-mentioned incision near the patient'"'"'s elbow, whereby the graft takes the form of a loop; and

connecting one end of said graft to an artery of the patient and connecting the other end of said graft to a vein of the patient.

5. A method for placing a loop access graft in the forearm of a patient with a tunneler, the tunneler having a shaft, and a tip and a handle interchangeable on opposite ends of the shaft, comprising the steps of:

incising lower and upper anterior regions of the forearm;

by manipulating the handle, introducing the tunneler into the lower incision until the tip is exposed at the upper incision to form a first tunnel;

interchanging the tip and handle on the shaft;

fastening one end of the graft to the tip;

by manipulating the handle, withdrawing the tunneler from the first tunnel until the one end of the graft is exposed at the upper incision; and

unfastening the one end of the graft from the tip.

6. A method according to claim 14 further comprising the steps of:

by manipulating the handle, introducing the tunneler into the lower incision until the tip is exposed at the upper incision to form a second tunnel;

interchanging the tip and handle on the shaft;

fastening the other end of the graft to the tip;

by manipulating the handle, withdrawing the tunneler from the second tunnel until the other end of the graft is exposed at the upper incision and a loop, formed in the graft by withdrawing the tunneler from the second tunnel, is pulled into the lower incision; and

anastomosing the respective ends of the graft to the radial artery and cephalic vein in the upper region of the forearm and closing the incisions.

7. A method for placing a loop access graft in between distal and proximal regions of a patient'"'"'s extremity with a tunneler, the tunneler having a shaft, and a tip and handle interchangeable on opposite ends of the shaft, comprising the steps of:

by manipulating the handle, introducing the tunneler into the distal region until the tip is exposed at the proximal region to form a first tunnel;

interchanging the tip and handle on the shaft;

attaching one end of the graft to the tip;

by manipulating the handle, withdrawing the tunneler from the first tunnel until the one end of the graft is exposed at the proximal region; and

detaching the graft from the tip.

8. A method according to claim 7 further comprising the steps of:

by manipulating the handle, introducing the tunneler into the distal region until the tip is exposed at the proximal to form a second tunnel;

interchanging the tip and handle on the shaft;

attaching the other end of the graft to the tip;

by manipulating the handle, withdrawing the tunneler from the second tunnel until the other end of the graft is exposed at the proximal end and the loop end is at the distal region; and

anastomosing the ends of the graft respectively to the adjacent artery and vein.