Implantable medical device deployment within a vessel

• US 9,854,982 B2
• Filed: 05/29/2012
• Issued: 01/02/2018
• Est. Priority Date: 03/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Allan, James Calvin, Griswold, Erik C., Havel, William J., Waldhauser, Steven L., Wien, Kelly M., Yasger, Kendra, Beasley, Rudolph A., Schell, Jon D., Tran, Don H.
• Primary Examiner(s): TURCHEN, ROCHELLE DEANNA
• Application Number:
  US13/482,880
• Publication Number:
  US 20130253309A1
• Time in Patent Office: 2,044 Days
• Field of Search: 600407, 600420, 600423, 600424, 600431, 600434, 623 111, 623 112, 623 21
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 6/00 Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment instruments measuring radiation intensity for application in the field of nuclear medicine, e.g. in vivo counting, G01T1/161; apparatus for taking X-ray photographs G03B42/02
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

In one example, this disclosure is directed to a method for intravascular implantation of an implantable medical device comprising positioning a distal end of an elongated outer sheath forming an inner lumen adjacent a target site within a vasculature of a patient, and partially deploying an implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element. A portion of the expandable fixation element assumes an expanded position when the implantable medical device is partially deployed from the distal opening. The method including advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening, and monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when the size of the portion of the expandable fixation element corresponds to the size of the vasculature.

Claims

1. A method for intravascular implantation of an implantable medical device within a patient comprising:

positioning a distal end of an elongated outer sheath forming an inner lumen with a distal opening adjacent a target site within a vasculature of the patient;

partially deploying the implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element with a looped element expandable from a collapsed position to an expanded position, wherein, in the expanded position, the looped element is configured to simultaneously contact opposite sides of the interior of the vasculature to secure the implantable medical device within the vasculature, wherein at least a portion of the expandable fixation element assumes the expanded position when the implantable medical device is partially deployed from the distal opening;

advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening; and

monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when a size of the portion of the expandable fixation element corresponds to a size of the vasculature.

2. The method of claim 1, wherein monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection comprises using fluoroscopy to view at least one of the vasculature and the portion of the expandable fixation element while advancing the distal end of the outer sheath within the vasculature.

3. The method of claim 1, further comprising injecting a contrast dye within the vasculature while monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection.

4. The method of claim 1,

wherein the inner lumen is a first inner lumen,

wherein the outer sheath is part of an assembly including an elongated inner sheath within the first inner lumen, wherein positioning the distal end of the outer sheath adjacent the target site within the vasculature includes positioning a distal end of assembly adjacent the target site within the vasculature,

wherein the inner sheath forms a second inner lumen, wherein an outer diameter of the inner sheath is smaller than a diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen,

wherein the implantable medical device is carried within the second inner lumen at a distal end of the inner sheath,

wherein the inner sheath forms a slit at the distal end of the inner sheath, adjacent a distal opening of the second inner lumen, to facilitate deployment of the implantable medical device out of the distal opening of the first inner lumen of the outer sheath,

wherein partially deploying the implantable medical device from the distal opening comprises sliding the distal end of the inner sheath out of the first inner lumen to expose a portion of the inner sheath and at least a portion of the implantable medical device out of the distal end of the outer sheath.

5. The method of claim 4, wherein the distal end of the inner sheath is elastically deformed within the first inner lumen such that the distal end of the inner sheath uncurls to expose the implantable medical device when the distal end of the inner sheath passes out of the distal opening of the first inner lumen of the outer sheath.

6. The method of claim 4, wherein at least a portion of the expandable fixation element assumes the expanded position when the distal end of the inner sheath passes out of the distal opening of the first inner lumen of the outer sheath.

7. The method of claim 6, further comprising deploying the implantable medical device from the inner sheath by retracting the inner sheath into the outer sheath after the portion of the expandable fixation element assumes the expanded position such that the distal end of the outer sheath interacts with the expandable fixation element to slide the implantable medical device out of the second inner lumen.

8. The method of claim 4, the method further comprising retracting the inner sheath into the outer sheath to return the implantable medical device to the first inner lumen.

9. The method of claim 8, wherein retracting the implantable medical device by retracting the inner sheath into the outer sheath causes the portion of the expandable fixation element to resume the collapsed position within the second inner lumen.

10. The method of claim 1, further comprising positioning an elongated deployment receptacle within the inner lumen of the outer sheath,

wherein the deployment receptacle includes a deployment bay at a distal end of the deployment receptacle, wherein the deployment receptacle is slidable within the inner lumen of the outer sheath, wherein the deployment bay carries the implantable medical device and facilitates deployment of the implantable medical device out of the distal opening of the inner lumen of the outer sheath.

11. The method of claim 10, wherein the deployment receptacle further comprises a tether that is remotely controllable from a proximal end of the deployment receptacle to release the implantable medical device from the deployment bay, the method further comprising remotely controlling the tether to deploy the implantable medical device from the deployment bay.

12. The method of claim 11, wherein the tether includes a helical element, wherein remotely controlling the tether to deploy the implantable medical device from the deployment bay includes rotating the helical element such that the helical element releases the looped element of the implantable medical device.

13. The method of claim 12, wherein partially deploying the implantable medical device from the distal opening includes pushing the implantable medical device out of the deployment bay with the helical element while the helical element remains attached to the looped element of the implantable medical device.

14. The method of claim 12, wherein partially deploying the implantable medical device from the distal opening includes pushing the implantable medical device out of the deployment bay while the helical element remains attached to the looped element of the implantable medical device.

15. The method of claim 14, wherein the looped element of the implantable medical device is part of the expandable fixation element.

16. The method of claim 1, wherein the implantable medical device includes at least one sensor selected from a group consisting of:

a pressure sensor;

an electrocardiogram sensor;

a fluid flow sensor;

an oxygen sensor;

an accelerometer;

a glucose sensor;

a potassium sensor; and

a thermometer.

17. The method of claim 1, wherein the target site is within a pulmonary artery of the patient.

18. The method of claim 17, wherein the implantable medical device includes a pressure sensor.

19. The method of claim 1, wherein the implantable medical device includes a pressure sensor, the method further comprising:

monitoring pressure within the vasculature with the pressure sensor with the implantable medical device partially deployed from the distal opening to test the functionality of implantable medical device at that location; and

after verifying functionality of implantable medical device at that location, fully releasing the implantable medical device to deploy the implantable medical device within the vasculature.

20. The method of claim 19, further comprising receiving an indication of the monitored pressure from the implantable medical device with an external programmer.

21. The method of claim 1, wherein the looped element forms an aperture that allows blood flow through the vasculature.