Surgery – Means for introducing or removing material from body for... – With means for cutting – scarifying – or vibrating tissue
Reexamination Certificate
1998-04-07
2003-05-13
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
With means for cutting, scarifying, or vibrating tissue
Reexamination Certificate
active
06561998
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices and methods, and more specifically to transluminal devices, systems and methods which are useable to enlarge interstitial tracts (e.g., man made puncture tracts or small passageways) which extend between two (2) anatomical conduits (e.g., blood vessels) or otherwise through tissue(s) within a mammalian body.
BACKGROUND OF THE INVENTION
Applicant has devised several new medical procedures wherein passageway-forming catheters are advanced into anatomical conduits (e.g., blood vessels) and are used to create one or more interstitial passageways which extend outwardly, from the conduit in which the catheter is positioned, to another conduit or anatomical structure. Some of these procedures may be used to form flow-through passageways between the anatomical conduit (e.g., blood vessel) in which the passageway-forming catheter is positioned, and another anatomical conduit (e.g., another blood vessel) or a different location on the same anatomical conduit (e.g., a downstream site on the same blood vessel). Alternatively, these procedures may be used to form access passageways between the anatomical conduit (e.g., blood vessel, urethra, fallopian tube, etc.) and another anatomical structure (e.g., a tumor, organ, muscle, nerve, etc.).
In at least some of applicant's procedures, the interstitial passageway(s) are initially formed by advancing a tissue-penetrating element (e.g., a small diameter needle or a flow of tissue-penetrating energy) from the passageway-forming catheter, through the wall of the anatomical conduit in which the catheter is positioned, and into the target location. In some cases, the interstitial passageway which is formed by the initial passage of the tissue-penetration element from the passageway-forming catheter is of relatively small diameter-and must subsequently be enlarged (e.g., debulked, dilated, expanded, stretched) to accommodate the desired flow of biological fluid (e.g., blood) or passage of other substances/devices therethrough.
In particular, as described in applicant's earlier-filed U.S. patent applications Ser. Nos. 08/730,327 and 08/730,496, such enlargement of the initially formed interstitial passageway (e.g., penetration tract) may be particularly important when the procedure is being performed to by-pass an obstruction within a coronary artery. For example, in some of applicant's procedures, a primary interstitial passageway is formed between an obstructed coronary artery and an adjacent coronary vein, such that blood will flow from the obstructed artery into the adjacent coronary vein. In such applications, the arterial blood which enters the adjacent coronary vein through the primary interstitial passageway is allowed to retroperfuse the ischemic myocardium by retrograde flow through the coronary vein. In other of applicant's procedures, one or more secondary interstitial passageways are formed between the coronary vein into which the arterial blood has flowed and the obstructed artery (or some other coronary artery) to allow arterial blood which has entered the coronary vein to reenter the obstructed artery (or some other coronary artery), after having bypassed the arterial obstruction. Thus, in either of these interventional procedures, it is important that the primary and/or secondary interstitial passageway(s) remain patent and sufficiently large in diameter to support the continued flow of arterial blood to the myocardium. However, the task of enlarging the small diameter interstitial passageway(s) (e.g., puncture tracts) formed by the initial passage of the tissue-penetrating element presents numerous technical challenges.
The prior art has included a number of catheter-based devices which may be used to enlarge or remove obstructive matter from the lumen of a blood vessel or other anatomical conduit (e.g., a blood vessel). These devices include; atherectomy catheters, embolectomy catheters, balloon angioplasty catheters, laser ablation catheters, etc. However, these prior art lumen-enlarging/lumen-clearing devices have typically not been intended for use in small diameter puncture tracts which diverge at an angle from the conduit lumen in which the catheter is located, as is typically the case in applicant's above-summarized interventional procedures.
Accordingly, there exists a need for the design and development of a new device, system and method for enlarging interstitial penetration tracts (e.g., man-made punctures or small passageways) which extend between adjacent anatomical conduits (e.g., blood vessels) within a mammalian body.
SUMMARY OF THE INVENTION
The present invention provides devices which are useable in combination with each other (i.e., as a system) to enlarge an interstitial tract (e.g., a small diameter penetration tract through tissue) which extends from a blood vessel or other anatomical conduit of the body. The tract enlarging systems of the present invention generally fall into three (3) major classifications—1) debulking-type systems, 2) dilating-type systems, 3) slicing-type systems and 4) two-catheter systems.
In accordance with the invention, one debulking-type tract enlargement system (referred to herein as an “advanceable” debulker) generally comprises: a) an elongate, pliable, tubular sheath sized for insertion into the lumen of an anatomical conduit from which the interstitial tract extends, said sheath having a lumen which extends longitudinally therethrough; b) a counter-traction member which is advanceable, i.) through the lumen of the tubular sheath and ii.) at least partially through the interstitial tract, such that the countertraction member engages or becomes positioned in relation to tissue which lies adjacent the interstitial tract to thereafter exert proximally-directed force upon such tissue; and, c) a debulker'(e.g., a tissue removing apparatus or flow of energy) which is advanceable out of the lumen of the sheath in a distal direction (i.e., substantially opposite the proximally-directed force being exerted by the counter-traction member) to remove tissue from the area adjacent the tract.
Further in accordance with the invention, there is provided another debulking-type tract enlargement system (referred to herein as a “retractable” debulker) generally comprises: a) an elongate, pliable, tubular sheath sized for insertion into the lumen of an anatomical conduit from which the interstitial tract extends, said sheath having a lumen which extends longitudinally therethrough, and b) a pull-back debulker (e.g., a tissue-removing apparatus or flow of energy) which is i.) initially advanceable out of the lumen of the sheath in a distal direction so as to pass through the penetration tract which is to be enlarged, and ii.) thereafter retractable in the proximal direction so as to remove, tissue which lies adjacent the interstitial tract, thereby enlarging the interstitial tract.
Still further in accordance with the invention, there is provided a dilating-type tract enlargement system (referred to herein as a “dilating” system) which generally comprises: a) an elongate, pliable, tubular sheath sized for insertion into the lumen of an anatomical conduit from which the interstitial tract extends, said sheath having a lumen which extends longitudinally therethrough, and b) a dilator (e.g., an elongate member) having at least one tissue-dilating member (e.g., a tapered, frusto-conical member, balloon or radial deployable member(s)) formed thereon, such dilator being advanceable into the penetration tract which is to be enlarged, and is subsequently useable to dilate such penetration tract, thereby resulting in the desired enlargement thereof. A positioning surface may be formed on the dilator to abut against tissue which lies adjacent the passageway in a manner which will enable the operator to determine that the dilator has been advanced to its desired position and is properly located to allow the dilate the interstitial tract as desired.
Still further in accordance with the invention, there
Flaherty J. Christopher
Johnson Adrian E.
Makower Joshua
Roth Alex T.
Whitt Jason Brian
Buyan Robert D.
Lam Ann
Nguyen Anhtuan T.
Stout, Uxa Buyan & Mullins, LLP
TransVascular, Inc.
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