# US 2008/0077219 A1 · Intravascular electrophysiological system and methods

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- Number: US 2008/0077219 A1
- Document ID: US20080077219A1
- Status: Published application
- Kind: A1
- Application number: 11/980,006
- Filed: 2007-10-30
- Published: 2008-03-27
- Earliest claimed: 2003-06-04
- Assignees: Synecor LLC
- Inventors: Michael Williams; Terrance Ransbury; Richard Glenn; Daniel Fifer; Kevin Holbrook
- Web page: https://patentgrep.com/patent/US20080077219A1

## CPC

- A61N 1/057: {Anchoring means; Means for fixing the head inside the heart}
- A61N 1/37512: {Pacemakers}
- A61N 1/37516: {Intravascular implants}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 1/37205: {Microstimulators, e.g. implantable through a cannula}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The present application describes an intravascular implantable pacing and/or defibrillation system. The described system includes a pulse generator that is implantable within a blood vessel and proportioned to blood flow through the blood vessel, and at least one electrode attachable to the pulse generator. During implantation, the pulse generator is introduced into a patient's vasculature, advanced to a desired vessel and anchored in place within the vessel. The electrode or electrodes are placed within the heart or surrounding vessels as needed to deliver electrical pulses to the appropriate location.

## Claims

### Claim at position 1

1-63. (canceled)

### Claim 64

A method for retaining a medical device within a blood vessel, comprising the steps of:
providing an expandable retention device and an intravascular medical device;
positioning the medical device in a blood vessel;
placing at least a portion of the retention device in contact with the medical device;
with the retention device in the compressed position, positioning the retention device in the blood vessel; and
expanding the retention device to the expanded position to retain the medical device within the vessel.

### Claim 65 (depends on 64)

The method of claim 64, wherein the placing step includes coupling the medical device and the retention device prior to the positioning step.

### Claim 66 (depends on 64)

The method of claim 64, wherein the placing step includes coupling the medical device and the retention device after the positioning step.

### Claim 67 (depends on 64)

The method of claim 64, wherein the medical device and retention device are separated components, and wherein the placing and expanding steps include expanding the retention device into contact with the medical device within the vessel.

### Claim 68 (depends on 67)

The method of claim 67, wherein the placing and expanding steps include:
with the retention device in the compressed position, positioning the retention device in the vessel adjacent to the medical device; and
expanding the retention device to the expanded position to engage the medical device between an exterior surface of the retention device and a surface of the vessel.

### Claim 69 (depends on 64)

The method of claim 64, wherein the retention device is an expandable retention sleeve.

### Claim 70 (depends on 69)

The method of claim 69, wherein the retention sleeve substantially minimizes blood flow between the retention sleeve and the medical device.

### Claim 71 (depends on 69)

The method of claim 69, wherein the retention sleeve includes a tubular member having end sections and an intermediate section between the end sections, and wherein the method includes positioning the intermediate section adjacent to the device, and radially expanding at least a portion of the end sections into contact with the vessel.

### Claim 72 (depends on 64)

The method of claim 64, wherein the method includes the step of positioning the retention device in the compressed position within a positioning sheath, and wherein the expanding step includes releasing the retention device from the positioning sheath.

### Claim 73 (depends on 72)

The method of claim 72, wherein the expanding step includes causing the retention device to self-expand after being released from the positioning sheath.

### Claim 74 (depends on 64)

The method of claim 64, wherein the expanding step includes positioning an expansion device within the retention device and expanding the expansion device.

### Claim 75 (depends on 74)

The method of claim 74, wherein the expansion device is a balloon.

### Claim 76 (depends on 64)

The method of claim 64, wherein the medical device is a pulse generator.

### Claim 77 (depends on 64)

The method of claim 64, wherein the medical device is a lead.

### Claim 78 (depends on 64)

The method of claim 64, further including the steps of positioning a liner within the vessel and positioning the medical device within the liner, and wherein the expanding step include expanding the retention device within the liner to engage the medical device between the retention device and the liner.

### Claim 79 (depends on 64)

The method of claim 64, further including the step of promoting tissue growth into the structure of the retention device.

### Claim 80

A retention device for retaining a medical device within a blood vessel, comprising:
an expandable member positionable in contact with an intravascular medical device and proportioned for receipt within a vessel, at least a portion of the expandable member expandable to radially engage a vessel wall and to thereby retain the medical device within the vessel.

### Claim 81 (depends on 80)

The retention device of claim 80, wherein the expandable member is a radially expandable tubular member.

### Claim 82 (depends on 80)

The retention device of claim 80, wherein the expandable member includes a coupling connected to an intravascular medical device.

### Claim 83 (depends on 82)

The retention device of claim 82, wherein the coupling supports the medical device out of contact with the vessel wall.

### Claim 84 (depends on 82)

The retention device of claim 82, wherein the coupling supports the medical device in contact with the vessel wall.

### Claim 85 (depends on 81)

The retention device of claim 81, wherein the tubular member includes radially expandable end sections proportioned to radially engage a vessel wall.

### Claim 86 (depends on 81)

The retention device of claim 81, wherein the tubular member includes end sections and a conformable intermediate section between the end sections.

### Claim 87 (depends on 80)

The retention device of claim 80, wherein the expandable member includes a blood-impermeable barrier.

### Claim 88 (depends on 87)

The retention device of claim 87, wherein the barrier includes a non-thrombogenic surface.

### Claim 89 (depends on 88)

The retention device of claim 88, wherein the non-thrombogenic surface is configured to elute a non-thrombogenic or anti-platelet agent.

### Claim 90 (depends on 87)

The retention device of claim 87, wherein the barrier includes an anti-proliferative surface.

### Claim 91 (depends on 90)

The retention device of claim 90, wherein the anti-proliferative surface is configured to elute an anti-proliferative agent.

### Claim 92 (depends on 87)

The retention device of claim 87, wherein the barrier includes a surface configured to elute an immunosuppressive agent.

### Claim 93 (depends on 80)

The retention device of claim 80, wherein at least a portion of the expandable member includes a structural framework.

### Claim 94 (depends on 80)

The retention device of claim 80, further including a tubular vessel liner, wherein the tubular member is proportioned to be received within the vessel liner within a vessel, such that the retention device retains the medical device between the retention device and the liner.

### Claim 95 (depends on 80)

The retention device of claim 80, wherein the expandable member includes interstices for promoting tissue ingrowth.

### Claim 96

A method of delivering an electrical pulse to a heart, comprising the steps of:
positioning a first electrode within a blood vessel;
positioning a second electrode within the cardiovascular system; and
delivering an electrical pulse between the first and second electrodes.

### Claim 97 (depends on 96)

The method of claim 96, wherein the blood vessel is an artery.

### Claim 98 (depends on 96)

The method of claim 96, wherein the blood vessel is a vein.

### Claim 99 (depends on 98)

The method of claim 98, wherein the blood vessel is a subclavian vein.

### Claim 100 (depends on 98)

The method of claim 98, wherein the blood vessel is an inferior vena cava.

### Claim 101 (depends on 98)

The method of claim 98, wherein the blood vessel is a superior vena cava.

### Claim 102 (depends on 96)

The method of claim 96, wherein the step of positioning the second electrode includes positioning the second electrode in a blood vessel.

### Claim 103 (depends on 102)

The method of claim 102, wherein the second electrode is positioned in an artery.

### Claim 104 (depends on 103)

The method of claim 103, wherein the second electrode is positioned in a vein.

### Claim 105 (depends on 104)

The method of claim 104, wherein the second electrode is positioned in a subclavian vein.

### Claim 106 (depends on 104)

The method of claim 104, wherein the second electrode is positioned in an inferior vena cava.

### Claim 107 (depends on 104)

The method of claim 104, wherein the second electrode is positioned in a superior vena cava.

### Claim 108 (depends on 104)

The method of claim 104, wherein the second electrode is positioned in a middle cardiac vein.

### Claim 109 (depends on 104)

The method of claim 104, wherein the second electrode is positioned in a vessel selected from the group of vessels consisting of the pulmonary vein, hepatic vein, renal vein, axillary vein, lateral thoracic vein, internal thoracic vein and splenic vein.

### Claim 110 (depends on 96)

The method of claim 96, wherein the second electrode is positioned within a chamber of the heart.

### Claim 111 (depends on 110)

The method of claim 110, wherein the chamber is the right ventricle.

### Claim 112 (depends on 110)

The method of claim 110, wherein the chamber is the right atrium or left atrium.

### Claim 113 (depends on 110)

The method of claim 110, wherein the chamber is the left ventricle.

### Claim 114 (depends on 96)

The method of claim 96, wherein the second electrode is positioned within the coronary sinus of the heart.

### Claim 115 (depends on 96)

The method of claim 96, wherein the pulse is a defibrillation pulse.

### Claim 116 (depends on 96)

The method of claim 96, wherein the pulse is a cardioversion pulse.

### Claim 117 (depends on 96)

The method of claim 96, wherein the pulse is a pacing pulse.

### Claim 118 (depends on 96)

The method of claim 96, wherein the pulse is a cardiac resynchronization pulse.

### Claim 119 (depends on 96)

The method of claim 96, wherein the pulse delivers approximately 0.1-50 joules of energy.

### Claim 120 (depends on 119)

The method of claim 119, wherein the pulse delivers approximately 5-35 joules of energy.

### Claim at position 59

121-134. (canceled)