Stent delivery handle

Details Stent delivery handle Stent delivery handle

1999-04-09

2001-02-20

Nguyen, Anhtuan T. (Department: 3763)

Surgery

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

Treating material introduced into or removed from body...

C604S164120

Reexamination Certificate

active

06190360

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to catheter-based systems for treating a remote location within a patient, and more particularly to handles for stent delivery systems, electrophysiology devices and the like, which include a catheter and a retractable sheath thereon.
BACKGROUND
Devices having a retractable sheath associated with a catheter are used to treat a variety of conditions using endoluminal methods instead of open surgical procedures. For example, angioplasty and stent implantation procedures are often used to treat atherosclerotic disease or other occlusive conditions in blood vessels, such as the coronary and carotid arteries. During angioplasty, a catheter having an uninflated balloon on its distal end is percutaneously introduced into a patient's vasculature and advanced to a target treatment location, such as a stenosis within a blood vessel. Once the balloon is properly placed across the stenosis, the balloon is inflated to enlarge the lumen at the location. The balloon is then deflated, the inflation/deflation procedure may be repeated, and then the catheter is withdrawn from the patient's body.
Often in conjunction with angioplasty, a stent or other tubular prosthesis may be implanted within a stenosis to scaffold the location and prevent it from contracting or otherwise becoming obstructed again. The stent is generally placed upon a catheter in a contracted condition, possibly over a balloon, the catheter advanced to the target stenosis until the stent is placed across the location, and then the stent is deployed and substantially anchored at the location. The stent may be biased to expand to an enlarged condition and/or may be expanded with the aid of a balloon, as with plastically deformable stents, until the stent substantially engages the wall of the vessel. Once the stent is implanted, the delivery catheter is withdrawn from the patient.
Similarly for ablation procedures and the like, a catheter including an array of electrodes, for example, on an expandable basket assembly, may be provided. The device may be introduced into a body lumen, for example through the patient's vasculature into the heart, to treat conditions, such as heart arrhythmia.
With any of these systems, a sheath may be provided over the distal end of the catheter to protect the components on the distal end, such as a balloon, a stent or an array of electrodes. The sheath may be advanced distally over the proximal end of the catheter until it covers the distal end and its components, or the distal end of the catheter may be introduced into the sheath, and advanced until it is proximate the distal end of the sheath. Once the distal end of the catheter is properly positioned at a desired location within a body lumen, the sheath may be retracted to expose the distal end of the catheter. After treatment, the sheath may be advanced back over the distal end of the catheter, and the entire device withdrawn from the patient.
To cause the sheath to retract, the proximal end of the sheath outside the patient may simply be pulled while holding the catheter in a fixed position. This, however, may not provide very precise control of the retraction of the sheath. To provide improved control, handle devices have been proposed which include a wheel and screw mechanism. A wheel extending around the circumference of the handle is coupled to a screw mechanism engaging the sheath and the catheter. As the wheel is rotated about the longitudinal axis of the handle, the screw mechanism directs the sheath axially with respect to the catheter.
With such devices, however, it may be difficult to remember which direction, i.e., clockwise or counterclockwise, is appropriate either to retract or advance the sheath with respect to the catheter. This may be particularly important when immediate action is necessary because of a complication during a procedure. In addition, these screw-type devices may be complicated, including many parts which may be difficult to assemble and/or expensive to make.
Accordingly, there is a need for more intuitive, more simple and/or less expensive devices for controlling catheter-sheath systems.
SUMMARY OF THE INVENTION
The present invention is directed to a handle device for an endoluminal apparatus that includes an outer tubular member and an elongate inner member slidably received in the outer tubular member. The handle device may include as few as two pieces, namely a handle member and a control member slidably associated with one another. The handle member preferably has proximal and distal ends and proximal and distal portions defining a longitudinal axis therebetween, and having a lumen extending axially between the proximal and distal ends. In a preferred form, the proximal portion includes gripping elements, and the distal portion has a relatively narrow cylindrical shape.
The handle member may include a locking mechanism thereon having an open position for allowing an elongate member, such as a catheter, to be inserted into the lumen in the handle member, and a closed position for fixing the axial position of the elongate member with respect to the handle member. In a preferred form, the locking mechanism also provides a hemostatic seal on the proximal portion of the handle member.
The control member is slidably coupled to the handle member and includes a tubular portion aligned concentrically with the lumen in the handle member and a control portion slidably received on the distal portion of the handle member. The control portion is slidable axially with respect to the handle member between distal and proximal positions.
Preferably, the control portion of the control member has a tubular shape defining a passage into which the distal portion of the handle member is slidably received. A proximal seal may be provided on the control portion of the control member for slidably engaging the distal portion of the handle member to facilitate sealing of the passage. In addition, a distal seal may be provided on the distal portion of the handle member for slidably engaging the control portion of the control member to further seal the passage. One of the proximal and distal seals may include an air vent for releasing air from within the passage when the control portion is directed proximally.
A locking mechanism may be provided for substantially securing the control portion in one of its proximal and distal positions. In a preferred form, the locking mechanism is a removable pin extending into both the control portion and the handle member, which may, for example, substantially secure the control portion in its distal portion to prevent premature retraction of a sheath coupled to the handle device.
In addition, the handle device also preferably includes a rail extending axially along the distal portion of the handle member, and a guide member on the control portion engaging the rail for preventing rotation of the control portion relative to the handle member about the longitudinal axis. In a first preferred embodiment, the rail may be an axial groove formed in the distal portion of the handle member, and the guide member may be an extension element, such as a tab or screw, extending from the control portion into the groove. In another preferred embodiment, the rail may be a raised rail member extending axially along the distal portion of the handle member, which may be attached to or integrally formed as part of the distal portion. The guide member may include a thumb wheel rotatably mounted to the control portion of the control member, the wheel engaging the rail member for directing the control portion axially upon rotation of the wheel.
In a preferred embodiment, the tubular portion of the control member may be disposed in the lumen of the handle member, and the tubular portion may be coupled to the control portion such that the tubular portion is directed axially within the lumen when the control portion is directed axially. Preferably, the tubular portion of the control member is coupled to the control portion by one or more hubs extendin

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