Subcutaneous lead guidance

• US 9,642,555 B2
• Filed: 07/15/2009
• Issued: 05/09/2017
• Est. Priority Date: 11/20/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonner, Matthew, Gardeski, Kenneth, Mehdizadeh, Bruce R., Christopherson, Roger, Neidert, Michael R.
• Primary Examiner(s): Cwern, Jonathan
• Application Number:
  US12/503,298
• Publication Number:
  US 20100125194A1
• Time in Patent Office: 2,855 Days
• Field of Search: 600424
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/067 using accelerometers or gyroscopes
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/026 where the straps are releasably secured, e.g. by hook and loop-type fastening devices
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

An apparatus for subcutaneous lead guidance includes a flexible guide strap, a navigation catheter and a tunneling tool. The guide strap includes an upper layer having a plurality of retainer formations and a substrate attachable on a patient'"'"'s skin extending between an incision and a target site. The navigation catheter is coupled to the upper layer via the retainer formations from a first end to a second end of the guide strap. The navigation catheter includes a plurality of position sensors for generating a subcutaneous navigation volume between the incision and the target site when the navigation catheter is coupled to a navigation system. The tunneling tool has a distal portion with a leading end and at least one position sensor on the distal portion for viewing digital representation of the distal portion in relation to the navigation volume on a display coupled to the navigation system.

Claims

1. An apparatus for subcutaneous lead guidance comprising:

a flexible guide strap having a first end and a second end, the guide strap adapted to be attachable on a patient'"'"'s skin to extend along a planned tunneling path between the first end positioned adjacent an incision and the second end positioned adjacent a target site;

a shielded flexible circuit and a plurality of induction coils attached to the guide strap to define the planned tunneling path from the incision to the target site;

a tunneling tool having a distal portion with a leading end and at least one position sensor on the distal portion; and

a feedback device coupled to the tunneling tool and the flexible circuit and configured to generate a first feedback signal as the leading end approaches the target site within the planned tunneling path and a second feedback signal different than the first feedback signal if the leading end veers off the planned tunneling path.

2. The apparatus of claim 1, further comprising a medical lead having a fixation member removably engageable with the leading end of the tunneling tool.

3. The apparatus of claim 1, wherein the generated navigation volume providing the subcutaneous path for the tunneling tool being dynamic in response to patient movement.

4. The apparatus of claim 1, wherein the digital representation of the distal portion in relation to the navigation volume on the display comprises a visual indication of the distal portion relative to an inner region of the navigation volume and an outer annular band of the navigation volume.

5. A method for subcutaneous lead guidance comprising:

attaching a first end of a substrate of a flexible guide strap on a patient'"'"'s skin adjacent to an incision site and a second end of the substrate over a target site, the guide strap including a shielded flexible circuit with a plurality of induction coils extending between the first end and the second end defining a planned tunneling path from the incision site to the target site;

guiding a tunneling tool subcutaneously through the incision to the target site without fluoroscopic assistance, the tunneling tool having at least one position sensor coupled to a distal portion of the tunneling tool;

and

enabling a feedback device coupled to the guide strap and the tunneling tool to measure a position signal from the position sensor and the induction coils and in response to the position signal generate a first feedback signal if the position sensor approaches the target site along the planned tunneling path and a second feedback signal different than the first feedback signal if the position sensor veers off the planned tunneling path to assist a user in advancing the leading end to the target site.

6. The method of claim 5, further comprising:

coupling a distal end of a medical lead to the leading end of the tunneling tool; and

guiding the distal end of the medical lead subcutaneously through the incision to the target site.

7. The method of claim 5, wherein the first feedback signal comprises a first audible frequency and the second feedback signal comprises a second audible frequency different than the first audible frequency.