Introducer assembly and method therefor

Details Introducer assembly and method therefor Introducer assembly and method therefor

2001-03-06

2003-07-15

Lazarus, Ira S. (Department: 3749)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S164100, C604S174000, C604S263000

Reexamination Certificate

active

06592553

ABSTRACT:

TECHNICAL FIELD
The present application generally relates to assemblies including introducers and lead assemblies. Specifically, it relates to an introducer assembly and suture sleeve, and lead and a method therefor.
BACKGROUND
Introducer devices are employed for inserting catheters, guide wires, or other medical devices into patients. A typical procedure provides for insertion of a needle into the vasculature of a patient. After insertion of the needle, a guide wire is inserted through the needle, and the needle is removed. The dilator and sheath assembly is inserted over the guidewire, and the dilator may be removed leaving the sheath protruding from the patient's vein or artery. A diagnostic or therapeutic catheter (e.g., a central venous access catheter) or guide wire or other medical device, is then inserted through the sheath into the patient, for example, within the heart.
In some cases, the medical device is implanted through the subclavian vein which passes between the first rib and a clavicle. As a person's upper arm moves, the space between the first rib and clavicle decreases, which decreases the space for the medical instrument therein. This can result in the medical instrument becoming compressed, and potentially stressed cyclically due to arm movements, possibly resulting in reduced longevity of the medical instrument inserted therein.
Accordingly, what is needed is an introducer assembly which allows for instruments to be more easily affixed within a patient. What is also needed is an introducing assembly which simplifies the implantation process and enhances the longevity of the instrument.
SUMMARY
An introducing assembly is provided which includes an elongate tubular sheath having an external diameter. The sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath extends from a distal end to a proximal end, and a protector is slidably disposed over the external diameter of at least a portion of the elongate sheath.
Several options for the introducing assembly are as follows. For instance, in one option, a dilator is disposed through the sheath. In another option, the sheath is separable without disruption to an instrument disposed therethrough, for example, where the sheath includes at least one line of weakness therein.
Further options are as follows. For instance, the protector is flexible. In another option, the protector extends from a first end to a second end, and at least the first end is tapered, and/or the second end is tapered. In yet another option, the protector includes one or more grooves thereon. In yet another option, the protector includes a longitudinal slot therein. Optionally, the protector is defined in part by an outer circumference, and the protector includes a means for reducing the outer circumference of the protector.
In another embodiment, an introducing assembly includes an elongate tubular sheath having an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath extends from a distal end to a proximal end, and a protector is slidably disposed over the external diameter of at least a portion of the elongate sheath. The protector has a longitudinal slot therein.
Several options for the introducing assembly are as follows. For instance, in one option, the protector extends from a first end to a second, and the slot extends from the first end to the second end. In another option, the protector extends from a first end to a second end, and the first end and/or the second end have beveled edges.
A method is also provided herein. The method includes inserting an introducing assembly into a living body, the introducing assembly including an elongate tubular sheath heaving an external diameter, the sheath having a bore including an internal diameter sized to receive a dilator therethrough. The sheath extends from a distal end to a proximal end, and a protector is slidably received over the external diameter of the sheath. The dilator is removably disposed through the sheath. The method further includes inserting the dilator into a vein or artery of the living body, inserting the sheath into the vein or artery, removing the dilator from the sheath, disposing an instrument through the sheath and into the vein or artery, and sliding the protector over a portion of the instrument.
Several options for the method are as follows. For instance, the method further includes securing the protector to the living body. In another option, the method includes separating and removing the sheath without damage to the instrument. Optionally, the method further includes moving the protector to a position in a costoclavicular space.
In yet another embodiment, a method is provided which includes inserting an introducing assembly into a living body. The introducing assembly includes an elongate tubular sheath having an external diameter, the sheath having a bore including an internal diameter sized to receive a dilator therethrough. The sheath extends from a distal end to a proximal end, and the dilator is removably disposed through the sheath. The method further includes inserting the dilator into a vein or artery of the living body, inserting the sheath into the vein or artery, removing the dilator from the sheath, disposing an instrument through the sheath and into the vein or artery, and sliding a protector over a portion of the instrument and into a costoclavicular space.
Several options for the method are as follows. For instance, the method further includes slidably disposing the protector over the sheath. In another option, the method further includes slidably disposing the protector over the instrument prior to disposing the instrument through the sheath. Optionally, the method further includes securing the protector within the costoclavicular space.
Advantageously, the assembly assists in preventing damage to lead insulation and/or lead conductors, resulting in enhanced lead longevity. Since the lead does not require a suture sleeve to be pre-mounted thereon, the outer diameter can be made smaller and more nimble, further allowing for use of a smaller catheter.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.


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