Intracardiac medical device

• US 10,449,354 B2
• Filed: 04/22/2016
• Issued: 10/22/2019
• Est. Priority Date: 04/23/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Demmer, Wade M, Bonner, Matthew D, Grubac, Vladimir
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US15/136,709
• Publication Number:
  US 20160310726A1
• Time in Patent Office: 1,278 Days
• Field of Search: 607126
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

An elongated implantable medical device for delivering electrical stimulation pulses to a patient includes a housing having a housing proximal end and a housing distal end and an electrical conductor having a conductor proximal end and a conductor distal end. The conductor distal end extends from the housing proximal end. The housing has a first fixation force at a first implant site after being implanted in a patient'"'"'s body, and the conductor proximal end has a second fixation force at a second implant site after being implanted in a patient'"'"'s body. The second fixation force is different than the first fixation force.

Claims

1. An implantable medical device for delivering electrical stimulation pulses to a patient, comprising:

at least a first electrode and a second electrode;

a housing having a housing proximal end and a housing distal end and carrying at least the first electrode;

a pulse generator enclosed by the housing for producing electrical stimulation pulses delivered using at least one of the first electrode and the second electrode;

a sensing module enclosed by the housing for sensing cardiac electrical signals via at least one of the first electrode and the second electrode;

an electrical conductor having a conductor proximal end and a conductor distal end, the conductor distal end extending from the housing proximal end, the electrical conductor carrying at least the second electrode;

a first fixation member coupled to the housing distal end, the first fixation member being a first active fixation member and configured to have a first fixation force for anchoring the housing distal end at a first implant site after being implanted in a patient'"'"'s body; and

a second fixation member for anchoring the conductor proximal end at a second implant site after being implanted in a patient'"'"'s body spaced apart from the first implant site, the second fixation member located at the conductor proximal end, the second fixation member being a second active fixation member that is pre-configured relative to the first fixation force to have a second fixation force that is less than the first fixation force, such that the second fixation member dislodges prior to dislodgement of the first fixation member in response to strain on the electrical conductor, the strain being at least as strong as the second fixation force and less strong than the first fixation force,

wherein the second fixation member has a spring constant that allows the second fixation member to be deformed from a first, relaxed position to a second, deformed position under a force that is less than the first fixation force, the second deformed position allowing the second fixation member to be pulled free from the second implant site at the strain that is less strong than the first fixation force.

2. The device of claim 1, wherein the second fixation member is a helical fixation member and the first fixation member comprises a plurality of curved tines.

3. The device of claim 1, wherein the first fixation member has a perforating tip that pierces body tissue at the first implant site.

4. The device of claim 1, wherein the first fixation member is a helical fixation member and the second fixation member comprises a plurality of tines.

5. The device of claim 1, wherein the first fixation member is a first helical fixation member and the second fixation member is a second helical fixation member having the second fixation force less than the first fixation force due to the second fixation member having at least one of a shorter length, smaller pitch, lower spring constant, smaller outer diameter, lower material stiffness, or smaller wire diameter than the first helical fixation member.

6. The device of claim 1, wherein the housing comprises at least one of:

a coating covering at least a portion of an exterior of the housing, the coating comprising any one or more of a porous material, a roughened surface, or a hydrophobic material for promoting tissue encapsulation of the housing;

or

a longitudinal wall extending between the housing proximal end and the housing distal end, the longitudinal wall comprising a concavity for promoting a narrowing of a tissue encapsulation of the housing.

7. The device of claim 1, wherein the conductor proximal end comprises a coating comprising any one or more of a smooth surface, an anti-inflammatory agent, a non-porous material, or a hydrophilic material.

8. The device of claim 1, further comprising:

a third electrode carried by the housing, the first electrode and the third electrode being a first anode and cathode pair for sensing cardiac electrical signals and delivering electrical stimulation pulses at the first implant site,

a fourth electrode carried by the proximal conductor end, the second electrode and the fourth electrode being a second anode and cathode pair for sensing cardiac electrical signals and delivering electrical stimulation pulses at the second implant site spaced apart from the first implant site.

9. The device of claim 1, wherein the conductor proximal end further comprises an attachment member for coupling to a delivery tool.

10. The device of claim 1, wherein the first implant site is in a first heart chamber and the second implant site is in one of the first heart chamber and a second heart chamber, wherein the electrical conductor has a length extending the second electrode away from the housing proximal end to the second implant site.

11. The device of claim 1, wherein the first fixation member comprises a first plurality of curved tines, and wherein second fixation member comprises a second plurality of curved tines.

12. An intra-cardiac pacemaker for delivering electrical stimulation pulses to a heart of a patient, comprising:

a first pair of electrodes and a second pair of electrodes;

a housing having a housing proximal end and a housing distal end and carrying the first pair of electrodes;

a pulse generator enclosed by the housing for producing electrical stimulation pulses delivered using at least one of the first pair of electrodes and the second pair of electrodes;

a sensing module enclosed by the housing for sensing cardiac electrical signals via at least one of the first pair of electrodes and the second pair of electrodes;

an electrical conductor having a conductor proximal end and a conductor distal end, the conductor distal end extending from the housing proximal end, the electrical conductor proximal end carrying the second pair of electrodes;

a first fixation member coupled to the housing distal end, the first fixation member being a first active fixation member and configured to have a first fixation force for anchoring the housing distal end at a first implant site after being implanted in a patient'"'"'s body; and

a second fixation member for anchoring the conductor proximal end at a second implant site after being implanted in a patient'"'"'s body spaced apart from the first implant site, the second fixation member located at the conductor proximal end, the second fixation member being a second fixation member that is pre-configured relative to the first fixation force to have a second fixation force that is less than the first fixation force, such that the second fixation member dislodges prior to dislodgement of the first fixation member in response to strain on the electrical conductor, the strain being at least as strong as the second fixation force and less strong than the first fixation force,

wherein the second fixation member has a spring constant that allows the second fixation member to be deformed from a first, relaxed position to a second, deformed position under a force that is less than the first fixation force, the second deformed position allowing the second fixation member to be pulled free from the second implant site at the strain that is less strong than the first fixation force.

13. The device of claim 12, wherein the second fixation member is a helical fixation member and the first fixation member comprises a plurality of curved tines.

14. The device of claim 12, wherein the first fixation member has a perforating tip that pierces body tissue at the first implant site.

15. The device of claim 12, wherein the first fixation member is a helical fixation member and the second fixation member comprises a plurality of tines.

16. The device of claim 12, wherein the first fixation member is a first helical fixation member and the second fixation member is a second helical fixation member having the second fixation force less than the first fixation force due to the second fixation member having at least one of a shorter length, smaller pitch, lower spring constant, smaller outer diameter, lower material stiffness, or smaller wire diameter than the first helical fixation member.

17. The device of claim 12, wherein the housing comprises at least one of:

a coating covering at least a portion of an exterior of the housing, the coating comprising any one or more of a porous material, a roughened surface, or a hydrophobic material for promoting tissue encapsulation of the housing;

or

a longitudinal wall extending between the housing proximal end and the housing distal end, the longitudinal wall comprising a concavity for promoting a narrowing of a tissue encapsulation of the housing.

18. The device of claim 12, wherein the conductor proximal end comprises a coating comprising any or more one of a smooth surface, an anti-inflammatory agent, a non-porous material, or a hydrophilic material.

19. The device of claim 12, wherein the conductor proximal end further comprises an attachment member for coupling to a delivery tool.

20. The device of claim 12, wherein the first implant site is in a first heart chamber and the second implant site is in one of the first heart chamber and a second heart chamber, wherein the electrical conductor has a length extending the second electrode away from the housing proximal end to the second implant site.

21. The device of claim 12, wherein the first fixation member comprises a first plurality of curved tines, and wherein second fixation member comprises a second plurality of curved tines.

22. An implantable medical device for delivering electrical stimulation pulses to a patient, comprising:

at least a first electrode and a second electrode;

a housing having a housing proximal end and a housing distal end and carrying at least the first electrode;

a pulse generator enclosed by the housing for producing electrical stimulation pulses delivered using at least one of the first electrode and the second electrode;

a sensing module enclosed by the housing for sensing cardiac electrical signals via at least one of the first electrode and the second electrode;

an electrical conductor having a conductor proximal end and a conductor distal end, the conductor distal end extending from the housing proximal end, the electrical conductor carrying at least the second electrode;

a first fixation member coupled to the housing distal end, the first fixation member being a first active fixation member and having a first fixation force for anchoring the housing distal end at a first implant site after being implanted in a patient'"'"'s body,

the conductor proximal end having a second fixation member that is a second active fixation member having a second fixation force for anchoring the conductor proximal end at a second implant site after being implanted in a patient'"'"'s body spaced apart from the first implant site, the second fixation force different than the first fixation force such that one of the first fixation member and the second fixation member dislodges prior to dislodgement of the other of the first fixation member and the second fixation member in response to strain on the electrical conductor,

wherein the second fixation member is a helical fixation member and the first fixation member comprises a plurality of curved tines and the helical fixation member has a spring constant that allows the helical fixation member to be stretched from a first, normally relaxed position to a second, stretched position under a force that is less than the first fixation force, the second stretched position being elongated and narrowed compared to the first, normally relaxed position allowing the second fixation member to be pulled free from the second implant site at the force along the electrical conductor that is less than the second fixation force.