SUBCUTANEOUS LEAD GUIDANCE

• US 20100125194A1
• Filed: 07/15/2009
• Published: 05/20/2010
• Est. Priority Date: 11/20/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Christopherson, Roger, Bonner, Matthew, Neidert, Michael R., Mehdizadeh, Bruce R., Gardeski, Kenneth
• Granted Patent: US 9,642,555 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• 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 including 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;

a navigation catheter coupled to the upper layer via the retainer formations from the first end to the second end of the guide strap, the navigation catheter including 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; and

a tunneling tool having 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.

2. The apparatus of claim 1, wherein the substrate comprises medical grade foam.

3. The apparatus of claim 1, wherein the upper layer comprises polyester material.

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

5. The apparatus of claim 1, wherein each retainer formation comprises a hoop having an opening and wherein the navigation catheter passes through each opening

6. A method for subcutaneous lead guidance comprising:

attaching a substrate of flexible guide strap on a patient'"'"'s skin between an incision and a target site, the guide strap having a plurality of hoops coupled to an upper layer of the guide strap;

passing a navigation catheter through the plurality of hoops, the navigation catheter having a plurality of position sensors;

operably coupling the navigation catheter to a navigation system;

generating a subcutaneous navigation volume between the incision and the target site;

viewing a digital representation of the subcutaneous navigation volume on a display of the navigation system;

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;

viewing a digital representation of the distal portion of the tunneling tool in relation to the navigation volume on the display; and

maintaining the leading end of the tunneling tool within the navigation volume.

7. The method of claim 6, further comprising providing a visual indication when the leading end of the tunneling tool veers outside the navigation volume.

8. The method of claim 7, wherein the visual indication includes change of color of digital representation of the leading end of the tunneling tool on the display.

9. The method of claim 6, further comprising providing an audible indication when the leading end of the tunneling tool veers outside the navigation volume.

10. The method of claim 6, further comprising:

coupling a distal end of 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.

11. The method of claim 6, wherein attaching a substrate of flexible guide strap on a patient'"'"'s skin between an incision and a target site includes attaching the guide strap between anterior and posterior position on the skin of the patient.

12. The method of claim 6, wherein attaching a substrate of a flexible guide strap on a patient'"'"'s skin between an incision and a target site includes

attaching a first guide strap between a lateral incision and an anterior position above an incision for an implantable device;

and

attaching a second guide strap between the lateral incision and a posterior target site.

13. The method of claim 12, wherein passing a navigation catheter through the plurality of hoops includes:

passing a first navigation catheter through a first plurality of hoops of the first guide strap; and

passing a second navigation catheter through a second plurality of hoops of the second guide strap.

14. An apparatus for subcutaneous lead guidance comprising:

a flexible guide strap having a first end and a second end, the guide strap attachable on a patient'"'"'s skin and extending between an incision and a target site;

a shielded flexible circuit and a plurality of induction coils attached to the guide strap and operably coupled to a connector for generating a subcutaneous navigation volume between the incision and the target site when the connector is operably coupled to a navigation system;

a tunneling tool having 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.

15. The apparatus of claim 14, further comprising a medical lead having a fixation member removably engageable with the leading end of the tunneling tool.

16. A method for subcutaneous lead guidance comprising:

attaching a substrate of a flexible guide strap on a patient'"'"'s skin between an incision and a target site, the guide strap including a shielded flexible circuit with plurality of induction coils;

operably coupling the induction coils to a navigation system;

generating a subcutaneous navigation volume between the incision and the target site;

viewing a digital representation of the subcutaneous navigation volume on a display of the navigation system;

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;

viewing a digital representation of the distal portion of the tunneling tool in relation to the navigation volume on the display; and

maintaining a leading end of the tunneling tool within the navigation volume.

17. The method of claim 16, further comprising:

coupling a distal end of 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.

18. A method for subcutaneous lead guidance comprising:

attaching a substrate of a flexible guide strap on a patient'"'"'s skin between an incision and a target site;

attaching a first electrode on a distal portion of a tunneling tool, the tunneling tool having a leading end;

attaching at least one second electrode on the guide strap at the target site;

operably coupling the first and second electrodes to an induction-based feedback system via electrical cable;

generating an alert signal indicative of the distance between the leading end of the tunneling tool and the target site; and

guiding the tunneling tool subcutaneously through the incision to the target site without fluoroscopic assistance based on the alert signal.

19. The method of claim 18, further comprising coupling a medical lead to the leading end of the tunneling tool.

20. The method of claim 18, wherein the alert signal includes an audible tone.

21. The method of claim 18, wherein the alert signal includes a visual alert.

22. The method of claim 18, wherein the alert signal includes an alert signal indicative of the leading end veering off a path defined by the guide strap.