Introducer system having kink resistant splittable sheath
First Claim
1. An introducer system for use with a catheter or lead comprising:
- a sheath having a first end and a second end, said sheath being compatible for insertion within a body, said first end configured to insert said sheath within said body with said second end extending out of said body, said sheath having a central lumen configured to permit introduction of at least one lead or catheter therethrough;
a flexible kink resistant section located along said sheath;
means for permitting removal of said sheath from said lead or catheter disposed therethrough without requiring said sheath to be removed from an end of said lead or catheter disposed therethrough; and
a dilator having a first end and a second end, said first end of said dilator being tapered, said dilator configured to be disposed through said central lumen of said sheath.
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Accused Products
Abstract
This invention relates to a flexible kink resistant introducer system for introducing an elongated object into the venous system and especially for introducing a cardiac pacemaker lead. The introducer system features a sheath having a kink resistant section allowing the sheath to be bent in that region and still allow a lead to be introduced therethrough. The kink resistant section comprises a series of bellows or pleats. The bellows or pleats may further be arranged to form a screw about a portion of the sheath to thereby permit the sheath to be screwed into body tissue. The sheath preferably is constructed to readily tear in a longitudinal direction and thus permits the system to be removed from the venous system without having to withdraw the sheath over an end of the pacemaker lead.
414 Citations
37 Claims
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1. An introducer system for use with a catheter or lead comprising:
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a sheath having a first end and a second end, said sheath being compatible for insertion within a body, said first end configured to insert said sheath within said body with said second end extending out of said body, said sheath having a central lumen configured to permit introduction of at least one lead or catheter therethrough; a flexible kink resistant section located along said sheath; means for permitting removal of said sheath from said lead or catheter disposed therethrough without requiring said sheath to be removed from an end of said lead or catheter disposed therethrough; and a dilator having a first end and a second end, said first end of said dilator being tapered, said dilator configured to be disposed through said central lumen of said sheath. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 33)
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17. An introducer system for use with a catheter or lead comprising:
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a sheath having a first end and a second end, said sheath further having a proximal span, an intermediate span and a distal span, said proximal span and said distal span having approximately equal length, said first end having means for inserting said sheath within said body with said second end extending out of said body, said sheath having a central lumen configured to permit introduction of at least one lead or catheter therethrough; a flexible kink resistant section located along said intermediate span; means for permitting removal of said sheath from said lead or catheter disposed therethrough without requiring said sheath to be removed from an end of said lead or catheter disposed therethrough; and a dilator having a first end and a second end, said first end of said dilator being tapered, said dilator disposed through said central lumen of said sheath. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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34. A method of introducing a body implantable lead comprising the steps of:
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introducing a percutaneous needle having a central lumen through a patient'"'"'s skin and into said patient'"'"'s blood vessel; introducing a wire guide through said central lumen and into said patient'"'"'s blood vessel; providing a rigid dilator through a lumen of an introducer sheath having a kink resistant section; introducing said rigid dilator and introducer sheath into said patient'"'"'s blood vessel a first distance, wherein said introducer sheath is straight; withdrawing said rigid dilator from said lumen of said introducer sheath; introducing said introducers sheath from said first distance, wherein said rigid dilator and introducer sheath are straight, to a second distance within said patient'"'"'s blood vessel, wherein said introducer sheath is bent at along said kink resistant section; and introducing a body implantable lead through said introducer sheath into said patient'"'"'s blood vessel. - View Dependent Claims (35, 37)
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36. A method of introducing a body implantable lead comprising the steps of:
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introducing a percutaneous needle having a central lumen through a patient'"'"'s skin and into said patient'"'"'s blood vessel; introducing a wire guide through said central lumen and into said patient'"'"'s blood vessel; providing a rigid dilator through a lumen of an introducer sheath having a bellowed section; introducing said rigid dilator and introducer sheath into said patient'"'"'s blood vessel a first distance, wherein said introducer sheath is straight; withdrawing said rigid dilator from said lumen of said introducer sheath; introducing said introducer sheath from said first distance, wherein said rigid dilator and introducer sheath are straight, to a second distance into said patient'"'"'s blood vessel wherein said introducer sheath is bent along said bellowed section; introducing a body implantable lead through said introducer sheath into said patient'"'"'s blood vessel; and removing said introducer sheath from said patient'"'"'s blood vessel without removing said sheath from over an end of said lead.
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Specification