Medical introducer apparatus

Claim 2

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and at least a first passageway extending therethrough; a second introducer sheath having a distal end, a distal portion, a proximal end, and at least a first passageway extending therethrough, the first and second introducer sheaths configured to be longitudinally splittable; the first and second introducer sheaths further configured to co-extend into a bodily passage, whereby the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; wherein the first introducer sheath includes a preformed bend in a portion of said sheath that extends in said bodily passage.

Claim 3

The introducer apparatus of claim 1 wherein the second introducer sheath is coaxially disposed within the first passageway of the first introducer sheath.

Claim 4

The introducer apparatus of claim 2 wherein the curvature of the at least one preformed bend has a radius of 10 cm or tighter.

Claim 5

The introducer apparatus of claim 2 wherein the first introducer sheath includes a plurality of preformed bends.

Claim 6

The introducer apparatus of claim 4 wherein the plurality of preformed bends include a distal bend and proximal bend, the distal and proximal bends formed such that the first introducer sheath generally comprises a serpentine configuration.

Claim 7

The introducer apparatus of claim 2 having an overall length of at least 20 cm.

Claim 8

The introducer apparatus of claim 6 wherein the first introducer sheath has a length of at least 35 cm, and the second introducer sheath has a length of at least 45 cm.

Claim 9

The introducer apparatus of claim 7 wherein the first introducer sheath has a length of at least 45 cm, and the second introducer sheath has a length of at least 55 cm.

Claim 10

The introducer apparatus of claim 2 wherein the distal portion of the second introducer sheath includes a preformed bend.

Claim 11

The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer sheath further includes an expandable member located about the distal end of the at least one of first and second introducer sheaths.

Claim 12

The introducer apparatus of claim 10 wherein the expandable member includes one or more inflatable balloons adapted to at least partially occlude a bodily passage.

Claim 13

The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer sheath further includes at least one retention element adapted for preventing retrograde migration of the at least one of first and second introducer sheaths.

Claim 14

The introducer apparatus of claim 1 further includes at least one steerage member adapted for placement within at least one passageway of at least one of the first introducer sheath and the second introducer sheath.

Claim 15

The introducer apparatus of claim 13 wherein at least one of the at least one steerage member selected from a group consisting of a dilator and an obturator.

Claim 16

The introducer apparatus of claim 13 wherein at least one of the at least one coaxial steerage member comprises a remotely controllable steerable member.

Claim 17

The introducer apparatus of claim 1 wherein at leas one of the first introducer sheath and the second introducer includes a plurality of passageways.

Claim 18

The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer includes a valve adapted to reduce retrograde flow of bodily fluids from within at least the first passageway thereof.

Claim 19

The introducer apparatus of claim 17 wherein said valve is longitudinally splittable.

Claim 20

The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer includes at least one of a radiopaque marker placed thereon or a radiopaque agent incorporated therewithin.

Claim 21

The introducer apparatus of claim 1 , wherein each of said first and second introducer sheaths has a preformed bend.

Claim 22

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and a first passageway extending therethrough; a second introducer sheath having a distal end, a distal portion, a proximal end, and a passageway extending therethrough, the second introducer sheath sized and configured for placement within the passageway of the first introducer sheath such that the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; wherein the first and second introducer sheaths comprise a molecularly oriented, non-isotropic polymer material such that the first and second introducer sheaths can be longitudinally split along at least one predetermined split line and removed from the patient; wherein at least one of the first introducer sheath and the second introducer sheath includes a preformed bend in a portion of said sheath that extends in said bodily passage.

Claim 23

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and a first passageway extending therethrough; a second introducer sheath having a distal end, a distal portion, a proximal end, and a passageway extending therethrough, the second introducer sheath sized and configured for placement within the passageway of the first introducer sheath such that the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; wherein the first and second introducer sheaths comprise a molecularly oriented, non-isotropic polymer material such that the first and second introducer sheaths can be longitudinally split along at least one predetermined split line and removed from the patient; wherein at least one of the first introducer sheath and the second introducer sheath includes a preformed bend in a portion of said sheath that extends in said bodily passage.

Claim 24

The introducer apparatus of claim 21 wherein the polymer material comprises polytetrafluoroethylene.

Claim 25

The introducer apparatus of claim 21 wherein the first introducer sheath includes a plurality of preformed bends.

Claim 26

The introducer apparatus of claim 23 wherein the plurality of preformed bends includes a distal bend and proximal bend, the first introducer sheath being so configured that when the first introducer sheath is placed within the vascular system of a patient such that the distal end of the first introducer is generally located within the region including the right atrium and coronary sinus of the patient, the proximal bend being generally located within, and generally conforming to the curvature of the right subclavian and innominate veins of the patient, while the distal bend is at least partially located within the right atrium and configured such that the distal end of the first introducer sheath is oriented toward the ostium of the coronary sinus of the patient.

Claim 27

The introducer apparatus of claim 23 wherein the first introducer sheath has a length of at least 35 cm, and the second introducer sheath has a length of at least 45 cm.

Claim 28

The introducer apparatus of claim 25 wherein the first introducer sheath has a length of at least 45 cm, and the second introducer sheath has a length of at least 55 cm.

Claim 29

The introducer apparatus of claim 23 further includes at least one steerage member adapted for placement within the passageway of at least one of the first introducer sheath and the second introducer sheath.

Claim 30

The introducer sheath of claim 21 , wherein at least one of the first introducer sheath and the second introducer sheath includes a longitudinally splittable valve adapted to reduce retrograde flow of bodily fluids from within at least the first passageway thereof.

Claim 31

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and one or more passageways extending therethrough; a second introducer sheath having a distal end, a distal portion, a proximal end, and one or more passageways extending therethrough, the first and second introducer sheaths configured to be longitudinally splittable; the first and second introducer sheaths further configured to co-extend into a bodily passage, whereby the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; at least one steerage member adapted for placement within at least one of the one or more passageways of at least one of the first introducer sheath and the second introducer sheath, the at least one steerage member being so configured such that placement thereof within a selected one of the one or more passageways permits the at least one of the first introducer sheath and the second introducer sheath to assume a configuration having at least one curve extending therealong during passage thereof through a bodily passage.

Claim 32

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and one or more passageways extending therethrough; a second introducer sheath having a distal end, a distal portion, a proximal end, and one or more passageways extending therethrough, the first and second introducer sheaths configured to be longitudinally splittable; the first and second introducer sheaths further configured to co-extend into a bodily passage, whereby the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; at least one steerage member adapted for placement within at least one of the one or more passageways of at least one of the first introducer sheath and the second introducer sheath, the at least one steerage member being so configured such that placement thereof within a selected one of the one or more passageways permits the at least one of the first introducer sheath and the second introducer sheath to assume a configuration having at least one curve extending therealong during passage thereof through a bodily passage.

Claim 33

The introducer apparatus of claim 29 wherein at least one of the at least one steerage member includes one or more preformed bends.

Claim 34

The introducer apparatus of claim 29 wherein at least one of the at least one steerage member comprises a remotely controllable steerable member.

Claim 35

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and a first passageway extending therethrough, the first introducer measuring 45 to 55 cm in length and further having a proximal bend and a distal bend, the first introducer sheath being so configured that when the first introducer sheath is placed within the vascular system of a patient such that the distal end of the first introducer is located within the right atrium of the patient, the proximal bend is generally located within, and generally conforms along the curvature of the right subclavian and innominate veins of the patient, while the distal bend is at least partially located within the right atrium and configured such that the distal end of the first introducer sheath is oriented toward the ostium of the coronary sinus of the patient; a second introducer sheath having a distal end, a distal portion comprising a preformed curve, a proximal end, and a first passageway extending therethrough, the second introducer sheaths measuring 55 to 65 cm in length and further sized and configured for placement within the first passageway of the first introducer sheath such that the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; at least one steerage member adapted for placement within the first passage of at least one of the first introducer sheath and the second introducer sheath, the at least one steerage member so configured such that placement thereof within the first passage of at least one of the first introducer sheath and the second introducer sheath permits the at least one of the first and second introducer sheaths to assume a configuration having at least one curve extending therealong during passage thereof through a bodily passage; wherein the first and second introducer sheaths comprise molecularly oriented, non-isotropic polytetrafluoroethylene such that the first and second introducer sheaths can be longitudinally split along at least one predetermined split line and removed from the patient.

Claim 36

A medical introducer apparatus, comprising: a first introducer sheath having a distal end, a proximal end and a first passageway extending therethrough, the first introducer measuring 45 to 55 cm in length and further having a proximal bend and a distal bend, the first introducer sheath being so configured that when the first introducer sheath is placed within the vascular system of a patient such that the distal end of the first introducer is located within the right atrium of the patient, the proximal bend is generally located within, and generally conforms along the curvature of the right subclavian and innominate veins of the patient, while the distal bend is at least partially located within the right atrium and configured such that the distal end of the first introducer sheath is oriented toward the ostium of the coronary sinus of the patient; a second introducer sheath having a distal end, a distal portion comprising a preformed curve, a proximal end, and a first passageway extending therethrough, the second introducer sheaths measuring 55 to 65 cm in length and further sized and configured for placement within the first passageway of the first introducer sheath such that the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath; at least one steerage member adapted for placement within the first passage of at least one of the first introducer sheath and the second introducer sheath, the at least one steerage member so configured such that placement thereof within the first passage of at least one of the first introducer sheath and the second introducer sheath permits the at least one of the first and second introducer sheaths to assume a configuration having at least one curve extending therealong during passage thereof through a bodily passage; wherein the first and second introducer sheaths comprise molecularly oriented, non-isotropic polytetrafluoroethylene such that the first and second introducer sheaths can be longitudinally split along at least one predetermined split line and removed from the patient.

Claim 37

The introducer sheath of claim 29 , wherein at least one of the first introducer sheath and the second introducer sheath includes a longitudinally splittable valve adapted to reduce retrograde flow of bodily fluids from within at least the first passageway thereof.