Steerable guide catheter with pre-shaped rotatable shaft

Claim 2

A guide catheter, comprising: an outer sheath comprising an open lumen, a pre-shaped distal end, a distal tip, a proximal end, and at least one longitudinally disposed pre-stress line extending from the proximal end to the distal tip of the outer sheath; an inner sheath comprising an open lumen, the inner sheath disposed within the open lumen of the outer sheath, the inner sheath axially rotatable and longitudinally translatable relative to the outer sheath, a distal end of the inner sheath conforming to a shape of the outer sheath when the inner sheath is retracted, and the distal end of the inner sheath assuming a pre-formed shape different from the shape of the outer sheath when the distal end of the inner sheath is extended beyond the distal end of the outer sheath; a steering tendon disposed along the outer sheath, a distal end of the steering tendon connected to the distal tip of the outer sheath; a guide handle connected to the proximal end of the outer sheath, the guide handle comprising at least one longitudinally disposed pre-stress line aligned with the at least one longitudinally disposed pre-stressed line of the outer sheath, and at least two elongated separation grips positioned at the proximal end of the guide handle aligned substantially parallel to the at least one longitudinally disposed pre-stress line of the guide handle, the guide catheter configured such that separation of the guide handle into at least two sections along the at least one longitudinally disposed pre-stress line of the guide handle initiates separation of the outer sheath along the at least one pre-stress line of the outer sheath; a steering mechanism comprising a lever pivotably disposed on the guide handle, the steering mechanism connected to a proximal end of the steering tendon and providing a pulling force on the steering tendon in response to pivoting of the lever to adjustably change a shape of the pre-shaped distal end of the outer sheath; at least one pressure sensing device connected to the distal end of the inner sheath; and at least one electrical conductor coupled to the at least one pressure sensing device, the at least one conductor disposed within the inner sheath.

Claim 3

A guide catheter according to claim 1 , wherein the lever of the steering mechanism comprises a steering handle.

Claim 4

A guide catheter according to claim 1 , wherein the inner sheath further comprises at least one longitudinally disposed pre-stress line extending from a proximal end to a distal tip of the inner sheath.

Claim 5

A guide catheter according to claim 1 , further comprising: at least one electrode on the distal end of the inner sheath; and at least one electrical conductor coupled to the at least one electrode, the at least one conductor disposed within the inner sheath.

Claim 6

A guide catheter according to claim 1 , further comprising: at least one electrode on the pre-shaped distal end of the outer sheath; and at least one electrical conductor coupled to the at least one electrode, the at least one conductor disposed within the outer sheath.

Claim 7

A guide catheter according to claim 1 , further comprising an occlusion device connected to the distal end of the inner sheath.

Claim 8

A guide catheter according to claim 1 , further comprising an occlusion device connected to the pre-shaped distal end of the outer sheath.

Claim 9

A guide catheter according to claim 1 , further comprising a retention mechanism provided on the guide handle to retain the steering lever at a fixed position.

Claim 10

A guide catheter according to claim 1 , wherein the pre-shaped distal end of the outer sheath further comprises: a substantially straight section at the distal tip of the outer sheath having a length of about 1 cm to about 5 cm; and a substantially circular curve proximally adjacent to the straight section, the circular curve having a bend radius ranging from about 0 degrees to about 180 degrees and a bend radius ranging from about 1 cm to about 7 cm.

Claim 11

A guide catheter according to claim 1 , wherein the pre-formed shape of the distal end of the inner sheath further comprises: a substantially straight section at the distal tip of the inner sheath having a length of about 0.5 cm to about 4.0 cm; and a substantially circular curve proximally adjacent to the straight section, the circular curve having a bend radius ranging from about 0 degrees to about 150 degrees and a bend radius ranging from about 1 cm to about 5 cm.

Claim 12

A guide catheter according to claim 1 , wherein the steering tendon is disposed on an outer surface of the outer sheath.

Claim 13

A guide catheter according to claim 1 , wherein the steering tendon is disposed within the open lumen of the outer sheath.

Claim 14

A guide catheter according to claim 1 , wherein the outer sheath further comprises a second lumen, the steering tendon disposed within the second lumen of the outer sheath.

Claim 15

The guide catheter according to claim 1 , wherein the retention mechanism comprises a locking arrangement configured to lock the steering lever at the fixed position.

Claim 16

The guide catheter according to claim 1 , wherein the retention mechanism comprises an arrangement configured to frictionally retain the steering lever at the fixed position.

Claim 17

A guide catheter, comprising: an outer sheath comprising an open lumen, a pre-shaped distal end, a distal tip, a proximal end, and at least one longitudinally disposed pre-stress line extending from the proximal end to the distal tip of the outer sheath; an inner sheath comprising an open lumen configured to receive a payload, the inner sheath disposed within the open lumen of the outer sheath, the inner sheath rotatable and longitudinally displaceable relative to the outer sheath, a distal end of the inner sheath conforming to a shape of the outer sheath when the inner sheath is retracted, and the distal end of the inner sheath assuming a pre-formed shape different from the shape of the outer sheath when the distal end of the inner sheath is extended beyond the distal end of the outer sheath; a steering member disposed along the outer sheath, a distal end of the steering member connected to the distal tip of the outer sheath; a guide handle connected to the proximal end of the outer sheath, the guide handle comprising at least one longitudinally disposed pre-stress line aligned with the at least one longitudinally disposed pre-stressed line of the outer sheath and at least two elongated separation grips positioned at the proximal end of the guide handle aligned substantially parallel to the at least one longitudinally disposed pre-stress line of the guide handle, the guide catheter configured such that separation of the guide handle into at least two sections along the at least one longitudinally disposed pre-stress line of the guide handle initiates separation of the outer sheath along the at least one pre-stress line of the outer sheath; a steering mechanism comprising a lever pivotably disposed on the guide handle, the steering mechanism connected to a proximal end of the steering tendon and from which a pulling force is developed on the steering tendon in response to pivoting of the lever to adjustably change a shape of the pre-shaped distal end of the outer sheath; at least one pressure sensing device connected to the pre-shaped distal end of the outer sheath; and at least one electrical conductor coupled to the at least one pressure sensing device, the at least one conductor disposed within the outer sheath.

Claim 18

A guide catheter, comprising: an outer sheath comprising an open lumen, a pre-shaped distal end, a distal tip, a proximal end, and at least one longitudinally disposed pre-stress line extending from the proximal end to the distal tip of the outer sheath; an inner sheath comprising an open lumen configured to receive a payload, the inner sheath disposed within the open lumen of the outer sheath, the inner sheath rotatable and longitudinally displaceable relative to the outer sheath, a distal end of the inner sheath conforming to a shape of the outer sheath when the inner sheath is retracted, and the distal end of the inner sheath assuming a pre-formed shape different from the shape of the outer sheath when the distal end of the inner sheath is extended beyond the distal end of the outer sheath; a steering member disposed along the outer sheath, a distal end of the steering member connected to the distal tip of the outer sheath; a guide handle connected to the proximal end of the outer sheath, the guide handle comprising at least one longitudinally disposed pre-stress line aligned with the at least one longitudinally disposed pre-stressed line of the outer sheath and at least two elongated separation grips positioned at the proximal end of the guide handle aligned substantially parallel to the at least one longitudinally disposed pre-stress line of the guide handle, the guide catheter configured such that separation of the guide handle into at least two sections along the at least one longitudinally disposed pre-stress line of the guide handle initiates separation of the outer sheath along the at least one pre-stress line of the outer sheath; a steering mechanism comprising a lever pivotably disposed on the guide handle, the steering mechanism connected to a proximal end of the steering tendon and from which a pulling force is developed on the steering tendon in response to pivoting of the lever to adjustably change a shape of the pre-shaped distal end of the outer sheath; at least one pressure sensing device connected to the pre-shaped distal end of the outer sheath; and at least one electrical conductor coupled to the at least one pressure sensing device, the at least one conductor disposed within the outer sheath.

Claim 19

The guide catheter of claim 16 , wherein the payload comprises a cardiac lead.

Claim 20

The guide catheter of claim 16 , wherein the payload comprises a cardiac lead configured for implantation with a coronary sinus or a branch vessel of the coronary sinus.

Claim 21

The guide catheter of claim 16 , wherein the payload comprises a pacing lead.

Claim 22

The guide catheter of claim 16 , wherein the payload comprises a defibrillation lead.

Claim 23

The guide catheter of claim 16 , wherein the payload comprises an injectable media.

Claim 24

The guide catheter of claim 16 , wherein the payload comprises a guide wire.

Claim 25

The guide catheter of claim 16 , wherein the payload comprises a guide wire and a cardiac lead having a lumen dimensioned to receive the guide wire, the lumen of the cardiac lead dimensioned to permit displacement of the cardiac lead over the guide wire.

Claim 26

The guide catheter of claim 16 , wherein the inner sheath further comprises at least one longitudinally disposed pre-stress line extending from a proximal end to a distal tip of the inner sheath.

Claim 27

The guide catheter of claim 16 , further comprising: at least one electrode on the distal end of the inner sheath; and at least one electrical conductor coupled to the at least one electrode, the at least one conductor disposed within the inner sheath.

Claim 28

The guide catheter of claim 16 , further comprising: at least one electrode on the pre-shaped distal end of the outer sheath; and at least one electrical conductor coupled to the at least one electrode, the at least one conductor disposed within the outer sheath.

Claim 29

The guide catheter of claim 16 , further comprising an occlusion device connected to the distal end of the inner sheath.

Claim 30

The guide catheter of claim 16 , further comprising an occlusion device connected to the pre-shaped distal end of the outer sheath.

Claim 31

The guide catheter of claim 16 , further comprising a retention mechanism provided on the guide handle to retain the steering lever at a fixed position.

Claim 32

The guide catheter of claim 16 , wherein: the pre-shaped distal end of the outer sheath further comprises: a substantially straight section at the distal tip of the outer sheath having a length of about 1 cm to about 5 cm; and a substantially circular curve proximally adjacent to the straight section, the circular curve having a bend radius ranging from about 0 degrees to about 180 degrees and a bend radius ranging from about 1 cm to about 7 cm; and the pre-formed shape of the distal end of the inner sheath further comprises: a substantially straight section at the distal tip of the inner sheath having a length of about 0.5 cm to about 4.0 cm; and a substantially circular curve proximally adjacent to the straight section, the circular curve having a bend radius ranging from about 0 degrees to about 150 degrees and a bend radius ranging from about 1 cm to about 5 cm.

Claim 33

The guide catheter of claim 16 , wherein the steering tendon is disposed on an outer surface of the outer sheath or within the open lumen of the outer sheath.

Claim 34

The guide catheter of claim 16 , wherein the outer sheath further comprises a second lumen, the steering tendon disposed within the second lumen of the outer sheath.

Claim 35

The guide catheter according to claim 16 , wherein the retention mechanism comprises a locking arrangement configured to lock the steering lever at the fixed position.

Claim 36

The guide catheter according to claim 16 , wherein the retention mechanism comprises an arrangement configured to frictionally retain the steering lever at the fixed position.