Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
2001-07-27
2003-07-29
Lewis, Ralph A. (Department: 3732)
Surgery
Instruments
Means for inserting or removing conduit within body
Reexamination Certificate
active
06599296
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to intraluminal catheters and devices. More specifically, the present invention relates to a device for actuating an intraluminal device. Intraluminal catheters and devices are currently employed in a variety of medical procedures. These procedures often require manipulation (or actuation) of the intraluminal device by a mechanism located outside of the patient's body. This invention relates to such devices which may be employed in a number of such procedures.
Catheters have long been used in intraluminal procedures for various medical needs. They generally are made from elongated tubes which may be placed within various body lumens. A common use for catheters is the treatment of vascular diseases. In such treatment, a catheter is inserted into a body vessel such as an artery. The catheter is then advanced through the artery to the site of the disease where treatment is performed.
A wide variety of treatments are currently available using different devices and mechanism delivered with or within, such catheters. For example, a stent or graft may be delivered to the site of a diseased artery and deployed within the artery. Other treatments employ the expanding of balloons (as in angioplasty) or delivery of drugs to treat arteries. Importantly, the treatment at the intraluminal site typically requires the manipulation of the catheter system external to the patient's body. That is, a physician-operator must actuate the catheter system into performing the intraluminal treatment by the use of devices which remain outside the patient's body. These devices are connected to the catheter system and are able to perform the treatment at the intraluminal site.
Certain medical terms regarding the orientation of medical devices are useful for a complete understanding of these devices. The term “distal” typically refers to a direction away from the operator of the device. Thus, the distal end of the catheter is inserted into the body and advanced distally through the vascular system. The term “proximal” typically refers to a direction towards the operator of the device. Thus, the proximal end of the catheter remains outside of the body and the catheter is withdrawn proximally to be removed from the body. These terms will be used herein for consistency.
An example of a known intraluminal procedure is the delivery of a self-expanding stent to the site of a stenosis (the narrowing of an artery due to vascular disease). Self-expanding stents typically employ spring forces which expand the stent radially outward to contact the arterial wall and maintain the arterial lumen in an expanded state. Typically, such a stent is mounted onto a catheter, collapsed to a smaller diameter and contained within a sheath for delivery. For deployment, the physician-operator may retract the sheath to expose the stent to allow it to expand for treatment. This may be accomplished by using a variety of actuator mechanisms connected to the proximal end of the catheter.
The actuator mechanism may be as simple as a knob independently attached to the catheter sheath. As the physician-operator pulls the knob proximally, the sheath withdraws proximally. Such a direct connection usually allows the physician some amount of control over the intraluminal procedure. Therefore, a direct controlling mechanism for performing the intraluminal procedure may be a preferred aspect of a catheter system.
As in the example described above, some intraluminal procedures require the retraction of sheaths, wires and the like while the main catheter remains stationary. Some procedures also require the advancement of similar devices. Simple solutions have been developed, such as attaching a knob, pull, or lever to the device requiring advancement or withdrawal. This allows some direct control by the physician-operator within, of course, certain limits.
One limitation in the use of a direct control device has been the distance required for advancing or retracting the device. As the distance increases, direct control of the device may become awkward or cumbersome. That is, a physician-operator may find it difficult to manipulate the control device over several inches while maintaining the remainder of the catheter system stationary.
Solutions to this problem include the use of pistol-grip handles with ratchet triggers. When one squeezes the trigger, the catheter system is actuated a certain distance, whereas releasing the trigger does not cause any further actuation. Thus, the catheter system can be repeatedly actuated in a single direction by repeatedly squeezing and releasing the trigger. These devices, however, do not provide direct control of the procedure. The squeezing of the trigger usually does not impart movement in the intraluminal device in one-to-one correspondence. Thus, a triggering mechanism inherently replaces the direct control by the physician with a mechanical relaying of control.
What has been needed is a mechanical device which allows direct manipulation of an intraluminal medical device that requires a lengthy displacement. The present invention satisfies these and other needs.
SUMMARY OF THE INVENTION
The present invention relates to a device for actuation of an intraluminal catheter system. More precisely, the present invention consists of a ratcheting handle which enables the actuation of an intraluminal catheter system in a direct correlation of transmitted motion, even when a large relative motion is required. The present invention includes a stationary base, a slidable pull back trigger or handle, a ratcheting system and a connection to the catheter system to create an overall intraluminal catheter system.
The present invention may enable actuation of a variety of intraluminal catheter systems. These systems, in turn, provide a variety of treatments. Known intraluminal treatments include, among others, vessel occlusion, angioplasty and the implantation of stents and grafts. Stents are intraluminal prosthesis which are implanted to expand and maintain the patency of body vessels. Grafts are also intraluminal prosthesis which may be used to replace body vessels or to isolate diseased vessels from the flow of blood.
Intraluminal treatments typically require actuation of the catheter system for treatment. For instance, in the implantation of a self-expanding stent, a sheath may be required to be retracted to allow the delivered stent to expand. When a particularly long stent is to be implanted, the sheath may be required to be retracted a greater distance than a physician-operator feels comfortable retracting in a single motion. The present invention provides a device to retract a sheath the required distance without requiring excessive manipulation by the physician-operator.
The present invention is configured to allow direct manipulation of the catheter system without a mechanical interface. Direct manipulation of the catheter system usually allows the physician the maximum amount of control over the intraluminal procedure. Thus, in the example described above, in which a sheath is retracted, the device of the present invention enables the physician to perform the procedure at an intraluminal site with directly corresponding motions. That is, as the physician withdraws the slidable pull-back trigger along the base, the sheath is retracted a corresponding distance at the intraluminal site. Since this device is in-line with, and directly connected to, the catheter system, the physician's motions directly correspond to the motion of the sheath.
The present invention also permits the direct actuation of catheter systems when the required retraction or motion is greater than a physician may feel comfortable in performing in a single motion. Thus, in the example of the delivery of a long self-expanding stent, the present invention permits the direct manipulation of the retractable sheath albeit in multiple motions. In such a procedure the physician may withdraw the pull-back trigger the length of the base, which may only correspond to a portion of t
Gillick Matthew J.
Stout Christopher A.
Tarapata Christopher J.
Advanced Cardiovascular Systems Inc.
Fulwider Patton Lee & Utecht LLP
Lewis Ralph A.
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