# US 7,610,105 B2 · Methods of using a guide wire stylet

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- Number: US 7,610,105 B2
- Document ID: US7610105B2
- Status: Granted
- Kind: B2
- Application number: 11/432,950
- Filed: 2006-05-12
- Published: 2006-09-14
- Granted: 2009-10-27
- Earliest claimed: 2003-09-30
- Assignees: Cardiac Pacemakers, Inc.
- Inventors: Bruce A. Tockman; Frank Vandeputte; Muralidharan Srivathsa; Randy Westlund
- Web page: https://patentgrep.com/patent/US7610105B2

## CPC

- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 2001/0585: {Coronary sinus electrodes}
- 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

Methods facilitate inserting a cardiac lead into a patient's vasculature. A cardiac lead system includes a cardiac lead having a lumen, and a guide member displaceable within the lumen. The guide member includes a guide wire extension that extends distal to the elongated body of the guide member. The guide wire extension is dimensioned to pass through an external distal opening of the cardiac lead lumen. Engagement of stop features or a stop mechanism of the cardiac lead system provides a push point for advancing the cardiac lead system through the patient's anatomy.

## Claims

### Claim 1

A method for advancing a cardiac lead system into a destination vessel, comprising:
providing a cardiac lead having a lumen extending from a proximal end of the lead to a distal external opening at a distal end of the lead, an electrode defining an exterior surface of the lead, and an electrical conductor;
providing a guide member displaceable within the cardiac lead lumen;
moving the guide member within the lumen of the cardiac lead so that a distal portion of the guide member extends beyond the distal external opening in the cardiac lead lumen;
engaging a first stop feature of the cardiac lead with a second stop feature of the guide member to provide a push point; and
advancing the distal external opening and the electrode of the cardiac lead into a destination vessel using force applied to the push point.

### Claim 2 (depends on 1)

The method of claim 1, wherein providing the cardiac lead having the lumen and the electrical conductor comprises providing the cardiac lead having a coiled electrical conductor, the coiled electrical conductor defining the lumen of the cardiac lead along at least a majority of the longitudinal length of the lumen.

### Claim 3 (depends on 2)

The method of claim 2, wherein engaging the first stop feature with the second stop feature comprises engaging a transition region of the cardiac lead, formed by a change in an inner diameter of the cardiac lead lumen defined by the coiled electrical conductor, with a transition region of the guide member, formed by a change in an outer diameter of the guide member.

### Claim 4 (depends on 2)

The method of claim 2, wherein:
providing the guide member comprises providing the guide member having a hollow elongated body and a guide wire displaceable within the hollow elongated body, the guide wire extendable beyond a distal end of the hollow elongated body; and
engaging the first stop feature with the second stop feature comprises engaging a transition region of the cardiac lead, formed by a change in an inner diameter of the cardiac lead lumen defined by the coiled electrical conductor, with the distal end of the hollow elongated body.

### Claim 5 (depends on 2)

The method of claim 2, wherein engaging the first stop feature with the second stop feature comprises engaging a transition region, formed by a change in an inner diameter lead lumen defined by the coiled electrical conductor, with a feature of the guide member, the feature of the guide member having a larger outer diameter relative to the outer diameter of the distal portion of the guide member.

### Claim 6 (depends on 2)

The method of claim 2, further comprising deflecting the distal portion of the guide member when the distal portion is distal of the distal external opening of the lumen.

### Claim 7 (depends on 6)

The method of claim 6, wherein:
providing the guide member comprises providing the guide member having a lumen and a moveable core displaceable within the guide member lumen; and
deflecting the distal portion of the guide member comprises advancing the moveable core into the distal portion of the guide member.

### Claim 8 (depends on 2)

The method of claim 2, wherein the cardiac lead lumen comprises a multi-diameter lumen defined by two longitudinal sections of the coiled electrical conductor having different inner diameters and a first diameter transitional region of the lumen between the two longitudinal sections, and the guide member comprises a multi-diameter guide member and a second diameter transitional region of the guide member, and wherein the first diameter transitional region serves as the first stop feature and the second diameter transitional region serves as the second stop feature to provide the push point.

### Claim 9 (depends on 2)

The method of claim 2, wherein;
the first stop feature is positioned near the distal end of the cardiac lead; and
the second stop feature is positioned near a distal end of the guide member.

### Claim 10 (depends on 1)

The method of claim 1, wherein:
providing the cardiac lead comprises providing the cardiac lead having a first set of mating features including one or more slots or depressions;
providing the guide member comprises providing the guide member having a second set of mating features compatible with the first set of mating features, the second set of mating features including one or more protrusions; and
the method further comprising engaging the first set of mating features with the second mating features to allow concurrent rotation of the guide member and the cardiac lead when rotational force is applied to one of the guide member or lead.

### Claim 11

A method for advancing a cardiac lead system into a destination vessel, comprising:
providing a cardiac lead having a lumen extending from a proximal end of the lead to a distal external opening at a distal end of the lead, an electrode defining an exterior surface of the lead, and an electrical conductor;
providing a guide member displaceable within the cardiac lead lumen;
moving the guide member within the cardiac lead lumen so that a distal portion of the guide member extends beyond the distal external opening in the cardiac lead lumen;
activating a stop mechanism, activation of the stop mechanism preventing further advancement of the guide member through the cardiac lead lumen; and
moving the distal external opening and the electrode of the cardiac lead and the distal portion of the guide member together in a destination vessel while the stop mechanism is activated.

### Claim 12 (depends on 11)

The method of claim 11, wherein providing the cardiac lead having the lumen and the electrical conductor comprises providing the cardiac lead having a coiled electrical conductor, the coiled electrical conductor defining the lumen of the cardiac lead along at least a majority of the longitudinal length of the lumen.

### Claim 13 (depends on 12)

The method of claim 12, wherein activating the stop mechanism comprises engaging a transition region of the lead, formed by a change in an inner diameter of the lumen defined by the coiled electrical conductor, with a feature of the guide member, the feature of the guide member having a larger outer diameter relative to the outer diameter of the distal portion of the guide member.

### Claim 14 (depends on 13)

The method of claim 13, wherein moving the distal external opening and the electrode of the lead and the distal portion of the guide member in the destination vessel further comprises applying axial force from the guide member to the lead through the engagement between the transition region of the lead and the feature of the guide member to advance the lead within the destination vessel.

### Claim 15 (depends on 11)

The method of claim 11, wherein activating the stop mechanism comprises inflating an inflation member, positioned on the guide member, within the cardiac lead lumen.

### Claim 16 (depends on 11)

The method of claim 11, wherein activating the stop mechanism allows concurrent rotation of the guide member and the cardiac lead such that rotation of one of the guide member and the lead rotates the other of the guide member and the lead.

### Claim 17 (depends on 11)

The method of claim 11, wherein activating the stop mechanism provides a push point for advancing the guide member and the cardiac lead together into the destination vessel by force applied to the push point.

### Claim 18 (depends on 11)

The method of claim 11, further comprising deflecting a distal portion of the guide member.

### Claim 19 (depends on 18)

The method of claim 18, wherein the distal portion of the guide member has a pre-formed shape.

### Claim 20 (depends on 11)

The method of claim 11, wherein:
providing the guide member comprises providing the guide member having a lumen and a moveable core displaceable within the guide member lumen; and
the method further comprising deflecting a distal portion of the guide member comprises deflecting a distal portion of the guide member by advancing the moveable core into the distal portion of the guide member.
