Subxiphoid procedures and apparatus for placement of cardiac defibrillator and pacer

• US 20040143284A1
• Filed: 02/18/2003
• Published: 07/22/2004
• Est. Priority Date: 01/17/2003
• Status: Active Grant

• Current Assignee: Origin Medsystems Inc. (Boston Scientific Corporation)
• Original Assignee: Origin Medsystems Inc. (Boston Scientific Corporation)
• Inventors: Chin, Albert K.
• Granted Patent: US 7,288,096 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

Surgical procedure and surgical instruments include an electrode structure for insertion through tissue superiorly of a subxiphoid incision to a position posterior of an aspect of the sternum and anterior of the pericardium. The electrode structure may be expanded, for example, including an inflatable member to position a number of electrodes of the electrode structure in contact with the pericardium. Alternatively, an electrode structure on an insertion cannula may be retained in contact with the pericardium by the cannula positioned within the dissected tissue. Electrical conductors from the contacting electrodes are routed through the tract of dissected tissue toward the subxiphoid incision for attachment to a generator that is implanted in a subcutaneous pocket near the subxiphoid incision.

Claims

1. A surgical instrument comprising:

an electrode structure including a number of electrodes disposed on a surface thereof near a distal end of an elongated body; and

a slide element carried by the elongated body to facilitate placement of the electrode structure with the number of electrodes contacting the pericardium of a patient'"'"'s heart, the slide element being removable from the electrode structure following said placement of the electrode structure.

15. A surgical instrument according to claim 1 in which the electrode structure includes a number of electrodes disposed to substantially surround the elongated body near the distal end thereof, the elongated body including at least one lumen therein;

a number of insulated electrical conductor disposed within a lumen and connected to respective ones of the number of electrodes; and

an obturator slidably removable from within the elongated body for selectively stiffening the elongated body from within a lumen along at least a portion of the length of the body.

16. The surgical instrument according to claim 15 including at least a pair of electrodes substantially surrounding the elongated body;

and including at least a pair of electrical conductors, each connected to an electrode and disposed within a lumen of the elongated body; and

the obturator is disposed within the lumen for selective removal therefrom for increased flexibility of the elongated body.

2. A surgical instrument comprising:

an electrode structure including a number of electrodes on a surface thereof connected to a distal end of an elongated body;

a sheath slidably supported on the body and overlaying the electrode structure for confining the electrode structure within the sheath in a distal slide position, and for exposing the electrode structure with the sheath in a proximal slide position; and

a fluid passage in communication with the electrode structure for expanding dimensions of the electrode structure to facilitate contacting the number of electrodes to the pericardium of a patient'"'"'s heart.

3. The surgical instrument according to claim 2 in which the electrode structure includes anterior and posterior membranes sealed together to form a pressurizable region therebetween, with at least two electrodes disposed in spaced relationship on an outer surface of the posterior membrane for expansion away from the anterior membrane in response to pressurization of the region between membranes.

4. The surgical instrument according to claim 2 including a support shaft attached to the electrode structure that is detachable from the elongated body and that includes a tissue-dissecting tapered tip on a distal end of the support shaft.

5. The surgical instrument according to claim 2 including an electrical conductor connected to each of the number of electrodes and extending along the elongated body within the sheath.

6. The surgical instrument according to claim 4 including detachable mating connectors disposed on a distal end of the elongated body and on a proximal end of the support shaft for selectively connecting the shafts.

7. The surgical instrument according to claim 6 in which the mating connectors include a fluid passage therethrough for passing fluid under pressure through the elongated body to the pressurizable region between membranes of the electrode structure.

8. The surgical instrument according to claim 4 in which the elongated body and sheath slidable thereon are arcuately shaped in concave configuration with one portion of a generally U-shaped elongated body extending in alignment with another portion thereof slidably supporting the sheath thereon.

9. The surgical instrument of claim 8 including an indicator tip extending along the one portion of the body substantially in alignment with the tapered tip on the distal end of the support shaft.

10. An electrode structure for contacting the heart of a patient comprising:

an anterior membrane and a posterior membrane of flexible substantially inelastic materials sealed together with a pressurizable region therebetween;

a number of electrodes disposed in spaced relationship on an outer surface of the posterior membrane;

an electrical conductor connected to each of the number of electrodes; and

a fluid conduit in fluid communication with the pressurizable region for supplying fluid under pressure thereto to expand the spacing between the membranes.

11. The electrode structure according to claim 10 in which the fluid conduit includes a support shaft attached to at least one of the membranes and including a lumen therethrough in fluid communication with the pressurizable region between the membranes.

12. The electrode structure according to claim 11 in which the membranes are substantially circular and are sealed about the periphery to form the pressurizable region between the membranes within the periphery thereof.

13. The electrode structure according to claim 111 including a tapered tissue-dissecting tip disposed on a distal end of the support shaft, and on a proximal end thereof a detachable connector for supplying fluid under pressure to the pressurizable region.

14. The electrode structure according to claim 13 including on a portion of the outer surface of the posterior membrane not including the number of electrodes a material adapted for fibrous adhesion to a pericardium.

17. A surgical procedure for contacting electrodes supported on an electrode structure to the heart of a patient, the procedure comprising the steps for:

forming a subxiphoid incision on the patient;

dissecting tissue along a tract superiorly from the subxiphoid incision to a posterior aspect of the patient'"'"'s sternum near the patient'"'"'s heart for advancing the electrode structure through the subxiphoid incision and along the tract of dissected tissue to the posterior aspect of the patient'"'"'s sternum; and

positioning the electrode structure within the region posterior to the posterior aspect of the patient'"'"'s sternum and anterior to the patient'"'"'s heart to form contact therewith of a number of the electrodes of the electrode structure.

18. The surgical procedure according to claim 17 including:

expanding the electrode structure within said region to form the contact with the pericardium outside the patient'"'"'s heart by each of the number of electrodes.

19. The surgical procedure according to claim 17 in which the electrode structure includes an inflatable member and conductors extending from each of the number of electrodes, and further comprises the steps for:

inflating the member to contact the number of electrodes with the patient'"'"'s heart; and

routing the conductors along the tract of dissected tissue toward the subxiphoid incision.

20. The surgical procedure according to claim 17 including a generator for supplying signals to the number of electrodes, and further comprising the steps for:

connecting a conductor for each of the number of electrodes to receive signals from the generator; and

implanting the generator subcutaneously in the patient near the subxiphoid incision.

21. The surgical procedure according to claim 19 performed using an insertion instrument and further comprising the steps for:

confining the inflatable member within the insertion instrument in one configuration thereof;

inserting the insertion instrument in the one configuration through the subxiphoid incision and along the tract of dissected tissue to the posterior aspect of the patient'"'"'s sternum;

re-configuring the insertion instrument in another configuration to expose the inflatable member; and

disengaging the insertion instrument from the inflated member for removal of the insertion instrument through the subxiphoid incision.

22. The surgical procedure according to claim 17 including radiologically visualizing placement of the electrode structure advanced to the posterior aspect of the patient'"'"'s sternum through the subxiphoid incision and along the tract of dissected tissue.

23. The surgical procedure according to claim 21 in which the insertion instrument is generally U-shaped with one portion for insertion through the subxiphoid incision, and with another portion in substantial alignment with the one portion and spaced therefrom, and further comprising the steps for:

inserting the one portion through the subxiphoid incision to position the electrode structure at the posterior aspect of the patient'"'"'s sternum with said another portion extending outside the patient'"'"'s body superiorly from the subxiphoid incision substantially coextensively with the one portion inside the patient'"'"'s body.

24. The surgical procedure according to claim 23 further comprising the step for:

determining positioning indicia for said another portion of the insertion instrument on the outside of the patient'"'"'s body superiorly of the subxiphoid incision for selectively positioning the one portion of the insertion instrument within the patient'"'"'s body with reference to the positioning indicia.

25. The surgical procedure according to claim 17 performed with an electrode structure disposed near the distal end of an elongated flexible body, the procedure including the steps for:

selectively stiffening the elongated body for positioning the electrode structure; and

removing stiffening of the elongated body following positioning of the electrodes in contact with the patient'"'"'s heart.

26. The surgical procedure according to claim 25 in which the elongated body slidably carries a substantially rigid obturator;

and

removing stiffening includes removing the obturator carried by the elongated body.