Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
1993-03-22
2001-10-30
Bockelman, Mark (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S102020, C604S500000, C604S523000
Reexamination Certificate
active
06309379
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a new class of intravascular devices and in particular to an intravascular device such as a selective delivery sheath used for positioning multiple other intravascular devices such as catheters, ultrasonic imagers, guide wires, or other devices in the vascular system of a patient. The present invention also relates to an intravascular device such as a balloon catheter that incorporates the new selective delivery sheath construction technology or methods.
BACKGROUND OF THE INVENTION
In the above referred-to applications, a new type of intravascular devices was disclosed. The new type of intravascular devices provided for the selective positioning of multiple other intravascular devices into a distal vascular region.
Interventional cardiology and interventional radiology have developed rapidly in recent years. Interventional therapies such as balloon angioplasty and atherectomy are now regularly employed in the treatment of vascular disease or other conditions that occlude or reduce the lumen size of portions of the vascular system. Additional therapeutic technologies and treatments hold promise for providing further advancement against vascular diseases.
In addition, intravascular diagnostic techniques have been developed to measure or image the extent of an occlusion of a vessel, (e.g. stenosis). Such diagnostic techniques include ultrasonic imaging, fiber optic imaging, Doppler and other flow measurements, and so on.
The above noted therapies and diagnostic techniques have achieved acceptance because of their effectiveness as well as the fact that they can be performed through a minor surgical procedure that is relatively non-disruptive to the patient. Therapeutic and diagnostic procedures, such as those described above, rely on the positioning of a device into the vascular system of a patient via an incision at a location, such as the femoral artery, that is remote from the site of the stenosis. Because the aforementioned therapies and diagnostic procedures rely upon positioning a device in the affected area, an important defining factor limiting the effective deployment of any of these devices is how small the device can be made. It is often in vessels of small inner diameters or tortuous passageways that stenosis occurs. Thus, it is often preferable to make such therapeutic and diagnostic devices as small as possible to fit into remote coronary sites or other vessel locations where the vessel lumen inner diameters are very small.
In order to facilitate placement and positioning of such therapeutic or diagnostic devices into distal vessel sites, positioning devices, such as guide wires and guide catheters, may be used. Guide wires are used to obtain a position in a distal vessel site so that other intravascular devices, such as a therapeutic or diagnostic device, can be advanced over the guide wire to the distal vessel site. Guide wires may be considered to support and facilitate the other types of interventional devices. Numerous kinds of guide wires are available, including steerable types. Guide wires may also be used therapeutically to open a passageway through a blocked vessel.
It is sometimes necessary to exchange one intravascular device for another. For example, it is sometimes necessary to exchange one balloon catheter for another of a different size or exchange a balloon catheter for another therapeutic or diagnostic device, if it is determined to be needed. Also, it is sometimes necessary to exchange guide wires, for example, if the physician is unable to cross a stenosis with the original guide wire. It is also sometimes necessary to use two balloons during the same procedure. Although presently available guide wires, guide catheters, and balloon dilation catheters provide for a degree of exchangeability, presently available intravascular devices are not readily exchangeable with newer emerging technologies or devices.
Accordingly, it is an object of the present invention to provide a new intravascular device that facilitates use and placement of multiple other intravascular devices in a vessel of a patient.
SUMMARY OF THE INVENTION
According to a first aspect of the invention, there are provided an intravascular device, such as a sheath, and methods for use thereof for selective positioning of multiple other intravascular devices in a distal vascular region of the body of a patient. The multiple other intravascular devices include, for example, a first intravascular device of a first predetermined size and a second intravascular device of a second predetermined size. The intravascular sheath comprises a tubular body having proximal, intermediate, and distal sections and a lumen extending therethrough. The portion of the lumen in the distal section is adapted and dimensioned to be occupied by a single vascular device of the predetermined sizes. The portion of the lumen in the intermediate section is dimensioned and adapted to be occupied by the two intravascular devices of the predetermined sizes in an adjacent, or side-by-side, relationship. In operation, two intravascular devices can occupy positions in the lumen in the intermediate section of the sheath at the same time. One of the intravascular devices is advanced into the lumen in the distal section of the sheath, or beyond, and a procedure may be performed. The first intravascular device is withdrawn back into the intermediate section, and then the other of the intravascular devices is advanced into or beyond the distal section. This allows for multiple diagnostics, therapies, or other procedures to be performed alternatively in a distal vascular region of the patient's body in which the distal section of the sheath is positioned.
In yet a further aspect of the present invention, the sheath construction can be incorporated into a therapeutic or diagnostic device such as a balloon catheter. This enables other therapies to be selected and employed in conjunction with a balloon dilation. The present invention offers the advantage of exchanging multiple devices by withdrawing one or the other into the intermediate region, thus saving time and reducing trauma to the vessel.
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Sieben Wayne
Whalen Mark
Willard Lloyd K.
Bockelman Mark
Lyon & Lyon LLP
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