Medical introducer apparatus
First Claim
1. 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.
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Accused Products
Abstract
An introducer apparatus (10) comprising a pair of co-extending splittable introducer sheaths (11), (12) is disclosed. The unique properties (pushability, torqueability, length, shape, etc.) of the individual introducer sheaths yields an introducer apparatus with the additional navigational flexibility to reach a remote target that whose access would be more difficult or impossible with a single introducer sheath. One embodiment include a coaxial pair of introducer sheaths made of made of molecularly oriented (non-isotropic) polytetrafluoroethylene PTFE which are used for placement of a pacemaker or defibrillator lead into the coronary sinus. In this embodiment, the first introducer sheath (11) is introduced over a wire guide into ostium of the coronary sinus, which represents the first target site. The outer introducer sheath includes preformed bends (20) to facilitate passage through the vasculature. A second introducer sheath (12), which includes a curved distal portion (17), is introduced through the first introducer where it extends from the distal end of the outer introducer sheath to access the second, ultimate target site, such as a coronary artery branching from the coronary sinus. After the pacemaker lead has been placed, both sheaths are split and removed from the patient.
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Citations
33 Claims
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1. A medical introducer apparatus, comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A medical introducer apparatus, comprising:
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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. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28)
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29. A medical introducer apparatus, comprising:
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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. - View Dependent Claims (30, 31, 33)
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32. A medical introducer apparatus, comprising:
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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.
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Specification