US 6,676,637 B1Granted

Single operator exchange fluid jet thrombectomy method

AssigneePossis Medical, Inc.

InventorsMichael J. Bonnette, Hieu V. Le, John Edward Morris, Stephen E. Weisel, Debra M. Kozak, Robert G. Dutcher

Life of this patent

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Abstract

A single operator exchange fluid jet thrombectomy method employing a single operator exchange fluid jet thrombectomy device having an outer catheter assembly and separable and exchangeable components in the form of an inner catheter assembly allowing functioning as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. The outer catheter assembly is common to any mode of usage and includes a guide catheter having a lumen through which a guidewire and the greater portion of a hypo-tube carrying a jet emanator and a flow director are passed and advanced. In the method, thrombus is dislodged, entrained, and broken into pieces by fluid jets and evacuated through the lumen of the guide catheter.

Claims14

Dependent claims

A method of removing undesired obstructing matter from a body vessel or cavity having an obstruction, the method comprising the steps of:

a. providing a guidewire and an outer assembly, the outer assembly having a proximal end and a distal end and including:
(1) a manifold situated at proximal end of the outer assembly, the manifold having a proximal end and a distal end;
(2) a first tube, the first tube connected to the manifold at the distal end of the manifold and having an interior annular surface and a distal end;
and,
(3) an externally located stationary hemostasis nut/stop at the proximal end of the manifold;
b. advancing the first tube distally in the body vessel or cavity until the distal end of the first tube is situated proximal to the obstruction of the body vessel or cavity;
c. advancing the provided guidewire through the first tube to the obstruction;
d. providing an inner assembly comprising a second tube having a proximal end and a distal end, with a jet emanator at the distal end of the second tube, a flow director including an expandable exhaust tube proximal to the jet emanator, and further having a high pressure connection assembly at the proximal end of the second tube;
e. advancing the inner assembly to a selected position within the first tube, such that the jet emanator is spaced apart from and extends past the distal end of the first tube, and the proximal end of the flow director remains proximal to the distal end of the first tube;
f. providing a high pressure fluid supply to the second tube causing:
(1) emanating of at least one jet of fluid from the jet emanator;
(2) entraining of undesired obstructing matter from the obstruction by the at least one jet of fluid;
(3) macerating of the undesired obstructing matter subsequent entrainment by the at least one jet of fluid;
and,
(4) transitting of the undesired obstructing matter following entrainment and maceration through the flow director and into the first tube for removal from the body vessel or cavity by the at least one jet of fluid;
and,
g. providing impingement of at least one jet upon the flow director to create sufficient stagnation pressure to both expand expandable exhaust tube of the flow director against the interior annular surface of the first tube and force evacuation of undesired obstructing matter subsequent entrainment and maceration through the flow director and first tube out of the body vessel or cavity with no requirement for additional suction.

14 more elements

A method of treating matter in a body vessel or cavity comprising the steps of:

a. providing an outer catheter having a proximal end and a distal end and at least a first lumen extending along its length and a stationary stop, and an inner assembly longer than the outer catheter and having a transitional stop and a jet emanator and a flow director which pass inside the first lumen of the outer catheter and can be exchanged for an alternate inner assembly, the flow director being adapted to substantially seal against the first lumen of the outer catheter , and a guidewire;
b. advancing the outer catheter until the distal end of the outer catheter is near the matter to be treated in the body vessel or cavity;
c. inserting the inner assembly into the outer catheter and advancing the inner assembly until at least a portion of the jet emanator and at least a portion of the flow director extend past the distal end of the outer catheter, utilizing the guidewire to facilitate advancement of the outer assembly or the inner assembly and utilizing the stationary stop and the transitional stop to determine the location of the inner assembly with respect to the outer assembly;
and,
d. providing pressurized fluid to the jet emanator causing emanation of at least one fluid jet from the jet emanator, entrainment and maceration of the matter to be treated in the body vessel or cavity, and flow of fluid and matter subsequent maceration through the flow director and into the first lumen of the outer catheter and creating a region of elevated pressure in at least a portion of the flow director.

2 more elements

A method of treating matter in a body vessel or cavity comprising the steps of:

a. providing an outer catheter having a proximal end and a distal end and at least a first lumen extending along its length, and an inner assembly longer than the outer catheter and haying a jet emanator and a flow director which pass inside the first lumen of the outer catheter the flow director being adapted to substantially seal against the first lumen of the outer catheter;
b. advancing the outer catheter until the distal end of the outer catheter is near the matter to be treated in the body vessel or cavity;
c. inserting the inner assembly into the outer catheter and advancing the inner assembly until at least a portion of the jet emanator and at least a portion of the flow director extend past the distal end of the outer catheters;
and,
d. providing pressurized fluid to the jet emanator causing emanation of at least one fluid jet from the jet emanator, entrainment and maceration of the matter to be treated in the body vessel or cavity, and flow of fluid and matter subsequent maceration through the flow director and into the first lumen of the outer catheter;
e. removing the inner assembly from the outer catheter;
f. providing an alternate inner assembly and introducing the alternate inner assembly into the outer catheter;
and,
g. using the alternate inner assembly to aid in treatment or diagnosis in the body vessel or cavity.

6 more elements

Dependencies are inferred from the claim text.

Facts

Application: 09/888,454Filed 25 Jun 2001 · continuation in part
Priority: 6 Feb 1998
Granted: 13 Jan 2004
Term ends: Not estimatedThe source records don’t support an estimate.

Classification6 codes

A61B 17/32037
Fluid jet cutting instruments: for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
A61B 2090/034
Abutting means, stops, e.g. abutting on tissue or skin: abutting on parts of the device itself
Y10T 83/0443
With preparatory or simultaneous ancillary treatment of work: by fluid application
Y10T 83/0453
With subsequent handling [i.e., of product]: by fluid application

Family

Application09/019,728Parent of this division · filed 6 Feb 1998
Application09/356,783Parent of this continuation-in-part · filed 16 Jul 1999
Application09/356,783Parent of this division
US 5,989,210 AParent of this division
US 6,676,637 B1This patent

From the US filing history. Foreign family members aren’t listed.