Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-12-01
2003-06-10
Bennett, Henry (Department: 3743)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S103010
Reexamination Certificate
active
06575932
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a local delivery device for the delivery of a therapeutic agent to a hollow tubular organ. More specifically the present invention relates to a multi-balloon catheter with an adjustable inter-balloon distance, adapted for delivery of a therapeutic agent to one or more variable lengths of a hollow organ segment.
BACKGROUND OF THE INVENTION
Vascular and lumenal catheters are widely used in medicine to treat a variety of vascular and lumenal diseases. In some instances, a catheter comprising an inflatable element such as a balloon is used to physically remove deposits on the interior of a tissue lumen. In other instances a catheter is used to deliver a therapeutic agent to a diseased portion of a tissue lumen. There are also catheters which combine inflatable elements and therapeutic agent delivery systems with the aim of treating diseased vessels.
Several recent catheter descriptions pertain to the use of dual-balloon catheters that when inflated define a sealed space suitable for the delivery of a drug or other therapeutic agent. In the catheter designs, the space between the two balloons is fixed. For example, U.S. Pat. No. 5,320,604 to Baxter-International Inc, discloses a single-lumen balloon catheter for embolectomy, dilation, occlusion and infusion of treatment fluids. The catheter shaft comprises a pair of expandable balloons spaced apart on the catheter. Located between the catheters is an infusion section comprising a perforation in fluid communication with the lumen of the catheter. Drugs or other treatment fluids may be delivered via the infusion section to the occluded region of the diseased tissue lumen. Analogous designs are provided for in U.S. Pat. No. 5,460,610 and U.S. Pat. No. 5,380,284. A three balloon catheter is disclosed in U.S. Pat. No. 5,176,638.
Similarly, U.S. Pat. No. 4,824,436 to Wolinsky describes a process for local administration of heparin and other agents to inhibit arterial smooth muscle cell proliferation using a catheter. The catheter contemplated in U.S. Pat. No. 4,824,436 comprises a proximal balloon and a distal balloon separated by a fixed distance. Located on the catheter, in between the two balloons is a perforation which is connected to an infusion lumen in the catheter. Heparin or other agents may be delivered through the catheter lumen to a vascular segment which has been occluded by inflation of both balloons. Also disclosed in the invention is the optional presence of a third balloon located in between the proximal and distal balloons referred to previously. The third balloon may be used to treat plaque deposits in vascular structures. After the middle balloon is deflated the proximal and distal balloons are expanded to create a chamber around the angioplasty site for the delivery therapeutic materials such as heparin. Following delivery of therapeutic material, the balloons are deflated and the catheter is removed. U.S. Pat. No. 5,662,609 relates to a catheter and a technique for treating diseased portions of tissue lumens by the introduction of at least one therapeutic agent at the diseased region. A catheter is positioned in a lumen such that a first and a second expansile member surrounds a diseased portion of tissue. Both expansile members are inflated to occlude the diseased region. A therapeutic agent is introduced into the occluded region of the diseased tissue lumen from a perfusion port located between the two expansile members. The catheter may also have other expansile members located in between, or outside of the first two expansile members. For example, a third expansile member may be provided between the first two expansile members. The inflation of the third member may function as an angioplasty balloon or other disruptive means. The devices disclosed in U.S. Pat. No. 4,824,436 and U.S. Pat. No. 5,662,609 require a plurality of lumens which increases the diameter of the catheter and therefore limits their use to hollow tubular organs of substantial cross section.
In U.S. Pat No. 5,817,113 to Heartport Inc, a drug delivery catheter which has a distal balloon and a proximal balloon separated by a few centimeters distance along the catheter shaft is disclosed. The catheter may have a single inflation lumen which connects to both balloons or separate inflation lumens. The catheter may also be provided with a flushing lumen which connects to a flushing port located on the catheter shaft for flushing of the site with saline to improve visibility of the structure. It is also disclosed that the catheter has a perfusion lumen for blood flow through the catheter. Drugs or other therapeutic molecules may be delivered via a lumen of the catheter to the drug delivery port on the catheter shaft located between the inflated balloons. U.S. Pat. No. 5,090,960, teaches the use of an offset two-catheter, two-balloon system. One catheter comprises a delivery port, and he other catheter a withdrawal port. One eccentric balloon is attached to each of the two catheters, and when inflated, these balloons push each of the catheters against the wall of the vessel. This catheter also provides openings on either side of the balloons, outside the isolated region, for the perfusion of blood through one of the catheters to ensure blood flow when the balloons are inflated.
U.S. Pat. No. 5,855,546 to Sci-Med Life Systems discloses a catheter device capable of simultaneous irradiation of blood vessels, angioplasty and drug infusion. The catheter is equipped with a helical perfusion balloon which when inflated defines a perfusion lumen which facilitates blood flow through the occluded artery portion. The catheter also comprises a lumen with perforations interspersed between the balloon windings to provide a confined volume for delivery of drugs to the vessel wall alone or in combination with radiation therapy.
U.S. Pat. No. 5,704,908 to Genetronics discloses an electroporation catheter for introducing molecules into cells at selected locations within a endoluminal structure. One embodiment comprises a pair of balloons spaced apart at a fixed distance on a guidewire. Each balloon comprises a separate electrode coating which in operation promotes electroporation of drugs or genes trapped or confined to the inter-balloon space into the cells of the endoluminal structure.
The above catheters provide for the delivery of a therapeutic agent to an isolated portion of a vascular segment, thereby permitting the treatment of the vessel lumen with one or a combination of therapeutic modalities, for instance, radiation, drugs, or genetic constructs. However, in all of these devices, the inter-balloon distance is fixed and the length of the vessel lumen which may be perfused with drugs is limited by the distance between the occluding balloons in the catheter structure.
U.S. Pat. No. 5,820,595 discloses an adjustable dual balloon catheter, however, there is no teaching that this catheter may be used as a local delivery device.
U.S. Pat. No. 5,919,163 relates to a dual balloon catheter with openings along the catheter stem located there between. The perforations along the catheter stem function to remove contaminated blood from the body. This catheter is used to isolate a region of interest and withdraw contaminated blood for further processing. The inter-balloon spacing of this catheter is adjustable, however the spacing is determined prior to insertion within the blood vessel. There is no teaching of drug delivery using this dual balloon catheter.
U.S. Pat. No. 5,342,306 discloses an adjustable dual balloon catheter, that comprises one perforation adjacent to a diffusable barrier that permits the supply of an agent within the isolated region between the two balloon portions. The one diffusion port is located at a fixed distance along the catheter, irrespective of the inter-balloon distance. With an increase in inter-balloon distance, the diffusion rate of any supplied agent within the isolated region would be low, requiring long insertion times for adequate diffusion of the medicament within the isolated re
Labinaz Marino
O'Brien Edward
Bennett Henry
Dagostino Sabrina
Heslin Rothenberg Farley & & Mesiti P.C.
Ottawa Heart Institute
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