APPARATUS AND SYSTEM FOR IMPLANTING AN AUTONOMOUS INTRACARDIAC CAPSULE

• US 20140031836A1
• Filed: 09/30/2013
• Published: 01/30/2014
• Est. Priority Date: 06/14/2010
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Ollivier, Jean-Franois
• Granted Patent: US 8,903,513 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

A system and method for implantation of an autonomous intracardiac capsule. The autonomous capsule includes a cylindrical body with an anchoring screw for penetrating a tissue wall, and at least one coupling finger radially projecting outwards. An implantation accessory includes a lead body and a helical guide, for guiding and driving by rotation the capsule. This helical guide is integral with the lead body, and its inner diameter is sufficient to contain that cylindrical body of the capsule therein. The helix direction of the helical guide is opposite to that of the anchoring screw such that continued rotational motion imparted on the lead body drives the anchoring screw into the target tissue and then emerges the capsule from the helical guide. The helical guide is resiliently compressible in axial direction, and its helix pitch is increased in the free distal end portion.

Claims

1. A system for implantation of a capsule in a wall of the heart cavity, comprising:

an autonomous capsule having a cylindrical body and at least one coupling finger secured to the cylindrical body and extending radially outward therefrom, wherein the cylindrical body comprises a projecting helical anchoring screw extending axially from one end of the cylindrical body, and wherein the anchoring screw comprises a plurality of coils having a helix direction; and

an implantation accessory having a proximal end and a distal end, the implantation accessory comprising a lead body and a helical guide extending axially from the lead body;

wherein the helical guide has an inner diameter that allows the capsule to be positioned within the inner diameter of the helical guide; and

wherein the helical guide comprises a plurality of coils having a second helix direction that is opposite to the first helix direction of the anchoring screw.

2. The system of claim 1, wherein the capsule comprises a distal end and a proximal end, a first coupling finger positioned towards the distal end and a second coupling finger positioned towards the proximal end.

3. The system of claim 1, wherein the helical guide is a projecting helix having pitch and axially extending along a length of the distal end of the lead body, and wherein the helix has an axis and is resiliently compressible in an axial direction.

4. The system of claim 3, wherein the pitch of the helix has a free distal end portion and said pitch is increased in the free distal end portion.

5. The system of claim 4, wherein the capsule comprises a distal end and a proximal end, a first coupling finger positioned toward the distal end and a second coupling finger positioned toward the proximal end, the first and second coupling fingers being spaced apart to provide a compression of the helix when the cylindrical body of the capsule is completely housed inside the helical guide.

6. The system of claim 3, wherein when the cylindrical body of the capsule is completely housed inside the helical guide, said system further comprises a soluble protective coating covering the capsule and its anchoring screw within the helical guide.

7. The system of claim 3, wherein the capsule further comprises a reset ramp extending from said at least one coupling finger, said ramp forming a portion of a helical thread with a helix direction opposite to that of the helical guide, and positioned to contact on the proximal side the free end of the helical guide.

8. The system of claim 1, wherein the distal end of the lead body comprises a hollow cylindrical tube extending axially and forming a housing for containing the capsule and having the helical guide, and means for deploying the anchoring screw comprising a pin-driven drive.

9. The system of claim 8, wherein the pitch of the helix has a free distal end portion and said pitch is increased in the free distal end portion.

10. The system of claim 9, wherein the capsule comprises a distal end and a proximal end, a first coupling finger positioned toward the distal end and a second coupling finger positioned toward the proximal end, the first and second coupling fingers being spaced apart to provide a compression of the helix when the cylindrical body of the capsule is completely housed inside the helical guide.

11. The system of claim 1, further comprising a flexible wire disposed in a lumen of the lead body, connecting the capsule to the proximal end of the lead body, said wire comprising near a point of attachment to the capsule a portion made of a resorbable material.

12. An autonomous intracardiac capsule, comprising:

a cylindrical body and at least one coupling finger secured to the cylindrical body and extending radially outward therefrom;

the cylindrical body having an outside diameter and at a distal end a projecting helical anchoring screw axially extending from the cylindrical body, to penetrate tissue of the wall of a cavity of the heart, the anchoring screw having a plurality of coils having a helix direction;

the cylindrical body configured to be received by a helical guide on an implantation accessory having a helix direction that is opposite to the helix direction of the anchoring screw, and the at least one coupling finger configured to engage with the helical guide.

13. The capsule of claim 12, further comprising the distal end and a proximal end, a first coupling finger positioned towards the distal end and a second coupling finger positioned towards the proximal end.

14. The capsule of claim 12, further comprising means for detecting depolarization potentials and/or delivering stimulation pulses coupled to at least one electrode carried by the capsule, including an electrode formed by a portion of the anchoring screw, and a transmitter/receiver means for wireless communication with a remote device.

15. The capsule of claim 12, wherein the plurality of coils of the helical anchoring screw further comprises a flexible transition portion and a distal portion of spaced apart coils, wherein the flexible transition portion is between the distal end of the cylindrical body and the spaced apart coils.

16. A method of implanting an autonomous capsule in a tissue wall, comprising:

providing a capsule for implantation by an implantation accessory,

wherein the capsule comprises a cylindrical body and at least one coupling finger secured to the cylindrical body and extending radially outward therefrom, wherein the cylindrical body comprises a projecting helical anchoring screw extending axially from one end of the cylindrical body, and wherein the anchoring screw comprises a plurality of coils having a helix direction;

wherein the implantation accessory comprises a lead body and a helical guide having a helix direction opposite of the helix direction of the anchoring screw;

preparing the capsule for implantation by engaging the at least one coupling finger of the capsule with the helical guide and positioning the cylindrical body within the helical guide, wherein the at least one coupling finger is positioned such that as the capsule is engaged with the helical guide the helix is compressed;

introducing the implantation accessory containing the capsule into a cavity of a body;

positioning the anchoring screw at the target tissue wall and engaging the anchoring screw with the target tissue by imparting rotational movement on the lead body;

once the anchoring screw has been engaged with the target tissue and the cylindrical body abuts the target tissue, continuing to impart rotational movement on the lead body, utilizing the opposite helix direction of the anchoring screw and the helical guide, to thereby rotate the helical guide about the cylindrical body to emerge the cylindrical body from the implantation accessory.

17. The method of claim 16, wherein the helical guide is a projecting helix having pitch and axially extending along a length of the distal end of the lead body.

18. The method of claim 16, wherein the distal end of the lead body comprises a hollow cylindrical tube extending axially and forming a housing for containing the capsule and having the helical guide, and means for deploying the anchoring screw comprising a pin-driven drive.

19. The method of claim 16, further comprising covering the anchoring screw and at least a distal portion of the implantation accessory with a soluble coating to protect the surrounding tissue during insertion into the body.

20. The method of claim 16, further comprising:

providing on the capsule a flexible wire extending from the capsule through the lead body of the implantation accessory and being accessible outside of the body.

21. The method of claim 20, further comprising determining whether repositioning of capsule is necessary, and if repositioning is necessary, pulling on the flexible wire to retrieve the capsule.

23. The method of claim 20, wherein the flexible wire further comprises a portion comprising resorbable material where the wire connects with the capsule.

22. The method of 18, further comprising removing the implantation accessory from the body.