US 5,396,902 A · Steerable stylet and manipulative handle assembly

Abstract

A steerable stylet and manipulative handle assembly for guiding a lead or a catheter to a desired location in a patient. The steerable stylet comprises an outer, elongated tubular member of a length sufficient to extend through the length of the lead or catheter from its proximal opening to the distal end thereof, a traction element or pull wire extending generally through the length of the tubular member and within its lumen except for a span in the distal portion thereof, and a manipulative handle coupled to the proximal ends of the tubular member and wire. Traction applied with one hand to the pull wire via the handle causes the distal portion of the tubular member to bend. Distal portion of the tubular member is provided with openings to allow the wire to exit and re-enter the lumen and facilitate bending of the tubular member. Distal portion of the tubular member which bends is preferably deformed, such as cut out or flattened or indented, to avoid kinking. A retainer surrounds the area proximate the openings and protects the exposed pull wire.

Drawings

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Drawings

Claims22

Dependent claims

A stylet and manipulative handle assembly controllable to form selected curvatures in a distal portion of a catheter or lead having a lumen extending therethrough, comprising:

an elongated tubular member having proximal and distal portions thereof and having an internal lumen said tubular member having a first side opening between said internal lumen and an external surface of said tubular member, and a second side opening, a span of said tubular member extending between said first side opening and said second side opening, said tubular member being deformed in cross-section along said span;
at least one traction element extending through said internal lumen, said traction element having a distal end and a proximal end, said distal end attached to said distal portion of said tubular member, said proximal end projecting from said proximal portion of said tubular member, said traction element extending through said first side opening and along said external surface of said tubular member;
and
a manipulative handle attached to said proximal portion of said tubular member and to said proximal end of said traction element for exerting tension on said traction element at said proximal end to form said tubular element to a desired degree of curvature depending upon the amount of tension and whereby said distal portion of said catheter or lead is similarly curved, wherein said manipulative handle comprises:
a longitudinal housing having a distal end thereof attached to said proximal portion of said tubular member and receiving said proximal end of said traction element therewithin;
a lever coupled for pivotal motion and adapted to be disposed transversely at least partially within said housing;
means for attaching said proximal end of said traction element to said lever;
and
a slide member coupled to said lever and adapted to slide upon said longitudinal housing for advancing and retracting a portion of said lever and thereby releasing and applying traction to said traction element to release or induce curvature in said distal portion of said elongated tubular member.

6 more elements

A stylet and manipulative handle assembly for insertion into a lumen of a hollow elongated catheter or lead body for imparting a curvature in a portion thereof, said stylet assembly comprising:

a two piece stylet adapted to be inserted into said lumen, said stylet comprising;
a tubular member having proximal and distal ends and proximal and distal portions, said proximal end having a proximal opening, at least one side opening in said distal portion;
a pull wire extending within said tubular member through said proximal opening therein and through said at least one side opening and extending along a span, said tubular member deformed by at least one longitudinal indentation in at least a portion of said span;
means for engaging said pull wire with said distal end of said tubular member and to mechanically couple said pull wire and said tubular member together;
and
a manipulative handle coupled to the proximal end of said tubular member and receiving said pull wire, said manipulative handle further comprising means for applying traction to said pull wire in said proximal direction to induce a curvature in said tubular member and in the adjacent elongated catheter or lead body.

3 more elements

A stylet and manipulative handle assembly for insertion into a lumen of a hollow catheter or lead body for imparting a curvature in a portion thereof, said stylet assembly comprising:

a stylet adapted to be inserted into said lumen, said stylet comprising;
a tubular member having proximal and distal ends and proximal and distal portions, said proximal end having a proximal opening, said tubular member having a first side opening and a second side opening;
a pull wire extending within said tubular member, said pull wire extending through said first opening along an exterior span of said tubular member and through said second side opening;
a retainer retaining said pull wire along said span so said pull wire will not contact said catheter or lead body;
means for engaging said pull wire with said distal end of said tubular member and to mechanically couple said pull wire and said tubular member together;
and
a manipulative handle coupled to the proximal end of said tubular member and receiving said pull wire, said manipulative handle further comprising means for applying traction to said pull wire in said proximal direction to induce a curvature in said tubular member and in the adjacent elongated catheter or lead body.

4 more elements

Dependencies are inferred from the claim text.

Description6,603 words

Summary2,716 words

#1. Field of the Invention

#The present invention relates to a wire guide or stylet assembly for the introduction of medical catheters or electrical leads to a desired site within a patient's body, and specifically to a steerable stylet assembly for imparting a desired dynamic curvature in the distal portion of a catheter or lead during its introduction in order to guide it through curvature in the patient's vascular system and to a desired site in the patient's cardiovascular system.

#2. Description of the Prior Art

Brief description of the drawings26 figures

#These and other objects, advantages and features of the invention will become more apparent and the invention will be more fully understood by reference to the drawings of the preferred embodiments thereof, wherein:

#FIG. 1 is a perspective view illustrating the steerable stylet and manipulative handle assembly of the present invention.

#FIG. 2 is a side elevation view of the manipulative handle assembly portion of the present invention depicting the slide member advanced distally to release traction to the pull wire and thus straightening the distal portion of the steerable stylet.

Detailed description3,261 words

#As described above, the steerable stylet and manipulative handle assembly of the present invention may be advantageously employed either for introducing an intravascular electrical sensing and/or stimulation lead, such as a transvenous or endocardial pacing or cardioversion lead, or a tubular catheter, such as a drug deliver, sensor-bearing, or lead removal catheter assembly. The specific leads or catheters are not within the scope of the present invention and, to the extent they are discussed, are only described in reference to their cooperation with the stylet and manipulative handle assembly of the present invention.

#Turning now to FIG. 1, it illustrates a perspective view of the steerable stylet and manipulative handle assembly 1 of the present invention assembled together and illustrating a certain degree of curvature imparted in the distal end thereof through retraction of pull wire 12 in relation to the elongated tubular member 10. The steerable stylet and manipulative handle assembly 1 comprises elongated tubular member 10 and pull wire 12 having proximal portion or section 14 and distal portion or section 16 with an elongated intermediate section extending therebetween (not specifically illustrated.) Distal section 16 possesses first and second apertures or openings 18, 20 separated apart span 15. As described hereafter, span 15 comprises a predetermined distance preferably in the range of 2.0 to 4.0 inches. This may further include the distal straight section extending between second opening 20 and distal tip or end 22. The radius of curvature to be imparted as pull wire 12 is retracted proximally is preferably between 0.50 and 1.5 inches although other dimensions can also be used.

#Pull wire 12 mechanically cooperates with distal tip or end 22 of tubular member 10 and extends within lumen 13 of tubular member 10, out second opening 20 and alongside tubular member 10 at span 15, whereupon it extends through first opening 18 and proximally through lumen 13 of tubular member 10 to proximal section 14. Pull wire 12 is only fixedly attached to tubular member 10 at distal end 22 and, in certain embodiments, it may extend distally from distal end 22 and terminate in an enlarged element having a diameter greater than the inside diameter of lumen 13.

Facts

Application

08/069,310Filed 28 May 1993 · continuation in part

Priority

3 Feb 1993

Granted

14 Mar 1995

Term ended

3 Feb 2013

Estimated · how

Pre-1995 term; greater of 17 years from grant or 20 years from filing when eligible. Maintenance-fee lapses, terminal disclaimers and statutory extensions have not been checked. The continuity chain may be incomplete; this is not an enforceability determination.

Classification4 codes

A61M 25/0138
Tip steering devices: having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
A61M 25/0136
Tip steering devices: handles therefor
A61M 25/0147
Tip steering devices: with movable mechanical means, e.g. pull wires
A61M
Devices for delivering substances into the body

Steerable stylet and manipulative handle assembly

Life of this patent

Steerable stylet and manipulative handle assembly

Life of this patent

Life of this patent

Abstract

Drawings

Drawings

Claims22

Description6,603 words

Drawings

Classification4 codes

Life of this patent

Description6,603 words