US-12616489-B2 - Systems and methods for removing undesirable material within a circulatory system during a surgical procedure

US12616489B2US 12616489 B2US12616489 B2US 12616489B2US-12616489-B2

Abstract

A method for capturing dislodged vegetative growth during a surgical procedure is provided. The method includes maneuvering, into a circulatory system, a first cannula having a distal end and an opposing proximal end, such that the first cannula is positioned to capture the vegetative growth en bloc. A second cannula is positioned in fluid communication with the first cannula, such that a distal end of the second cannula is situated in spaced relation to the distal end of the first cannula. A suction force is provided through the distal end of the first cannula so as to capture the vegetative growth. Fluid removed by the suction force is reinfused through the distal end of the second cannula. Subsequent to becoming dislodged, the vegetative growth is captured by the first cannula. A method for capturing a vegetative growth during removal of a pacemaker lead is also provided.

Inventors

Lishan Aklog
Michael J. Glennon

Assignees

ANGIODYNAMICS, INC.

Dates

Publication Date: 20260505
Application Date: 20250819

Claims (20)

1 . A method comprising: placing a first cannula at least partially within a vasculature; aspirating at least a portion of an undesirable material and blood from the vasculature through the first cannula and into a first container in fluid communication with the first cannula; coupling the first container to a filter assembly; coupling the filter assembly to a second container; flowing the aspirated undesirable material and the aspirated blood from the first container through a filter of the filter assembly, thereby filtering the aspirated undesirable material from the aspirated blood, to produce filtered blood in the second container, and wherein the aspirated undesirable material is capable of being viewed within the filter assembly; coupling the second container with a second cannula; and driving the filtered blood from the second container through the second cannula into the vasculature to reinfuse the filtered blood into the vasculature.
2 . The method of claim 1 , wherein the first container comprises a first reservoir configured to store the aspirated undesirable material and the aspirated blood, and the second container comprises a second reservoir configured to store the filtered blood.
3 . The method of claim 2 , wherein the first container and the second container each comprise a manually operated pump.
4 . The method of claim 3 , wherein the undesirable material is a pulmonary embolism.
5 . The method of claim 1 , wherein the filter assembly comprises an inlet configured to be in fluid communication with the first container and an outlet configured to be in fluid communication with the second container.
6 . The method of claim 1 , further comprising: placing the second cannula in a spaced relation to the first cannula within the vasculature.
7 . The method of claim 1 , wherein the filter comprises at least two filter screens each filter screen having a different pore size.
8 . The method of claim 1 , wherein the flowing of the aspirated undesirable material and the aspirated blood from the first container through the filter of the filter assembly and into the second container is performed until substantially all of the aspirated undesirable material has been filtered from the aspirated blood.
9 . The method of claim 1 , further comprising: determining to continue the flowing of the aspirated undesirable material and the aspirated blood from the first container through the filter of the filter assembly and into the second container until obtaining visual confirmation that substantially all of the aspirated undesirable material has been captured in the filter assembly.
10 . A method comprising: placing a first cannula at least partially within a vasculature; aspirating at least a portion of an undesirable material and blood from the vasculature through the first cannula and into a first container coupled to the first cannula; coupling the first container to a first filter assembly and coupling a second container to the first filter assembly; moving the aspirated undesirable material and the aspirated blood from the first container through a first filter of the first filter assembly into the second container, the first filter being configured to filter the aspirated undesirable material from the aspirated blood to produce filtered blood; coupling the second container to a second filter assembly; moving the filtered blood from the second container through a second filter of the second filter assembly, the second filter being configured to further filter the undesirable material from the filtered blood to produce a twice filtered blood; driving the twice filtered blood through a second cannula to reinfuse the twice filtered blood into the vasculature.
11 . The method of claim 10 , wherein the first cannula is a reinforced cannula, the undesirable material is a pulmonary embolism, and the vasculature comprises at least a part of the pulmonary system.
12 . The method of claim 10 , further comprising: viewing the aspirated undesirable material within the first filter assembly.
13 . The method of claim 12 , further comprising: continuing to move the aspirated undesirable material and the aspirated blood from the first container through the first filter of the first filter assembly and into the second container until obtaining visual confirmation that substantially all of the aspirated undesirable material has been captured in the first filter assembly.
14 . The method of claim 13 , wherein the first filter assembly comprises a first filter membrane having a first pore size and the second filter comprises a second filter membrane having a second pore size that is different from the first pore size.
15 . A method comprising: placing an aspiration cannula at least partially within a vasculature; aspirating at least a portion of an undesirable material and blood from the vasculature through the aspiration cannula and into a first container coupled to the aspiration cannula; coupling the first container in fluid communication with an inlet of a filter device, wherein the filter device comprises the inlet, an outlet and a filter membrane; fluidly coupling the outlet of the filter device with a second container; pulling the aspirated undesirable material and the aspirated blood from the first container through the filter membrane into the second container, the filter membrane being configured to filter substantially all of the aspirated undesirable material from the aspirated blood to produce filtered blood, viewing the filtered undesirable material entrapped within the filter device; fluidly coupling the second container with a reinfusion cannula; and reinfusing the filtered blood from the second container through the second cannula into the vasculature.
16 . The method of claim 15 , wherein the pulling of the aspirated undesirable material and the aspirated blood from the first container through the filter membrane into the second container is performed for a desired duration of time.
17 . The method of claim 15 , wherein the pulling of the aspirated undesirable material and the aspirated blood from the first container through the filter membrane into the second container is performed until the aspirated undesirable material has been confirmed removed by the viewing of the filtered undesirable material entrapped within the filter device.
18 . The method of claim 15 , wherein the aspiration cannula is reinforced and configured to optimize navigation of the aspiration cannula through the vasculature, and the undesirable material comprises a pulmonary embolism.
19 . The method of claim 17 , further comprising: placing the aspiration cannula coaxially over a guidewire.
20 . The method of claim 19 , wherein the aspiration cannula further comprises an expandable distal end defined by a funnel shape.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 19/013,019 filed on Jan. 8, 2025, which is a continuation of U.S. application Ser. No. 18/985,608 filed on Dec. 18, 2024, which is a continuation of U.S. application Ser. No. 18/942,929 filed on Nov. 11, 2024, which is a continuation of U.S. application Ser. No. 18/156,211 filed on Jan. 18, 2023, which is a continuation of U.S. patent application Ser. No. 16/458,529, filed Jul. 1, 2019 (now U.S. Pat. No. 11,589,880), which is a continuation of U.S. patent application Ser. No. 15/194,990, filed Jun. 28, 2016 (now U.S. Pat. No. 10,383,983), which is a continuation of U.S. patent application Ser. No. 14/250,486, filed Apr. 11, 2014 (now U.S. Pat. No. 9,402,938), which is a continuation of U.S. patent application Ser. No. 13/084,675, filed Apr. 12, 2011 (now U.S. Pat. No. 8,734,374), which is a continuation-in-part of U.S. patent application Ser. No. 12/187,121, filed Aug. 6, 2008 (now U.S. Pat. No. 8,075,510), which claims the benefit of U.S. Provisional Application No. 61/015,301, filed Dec. 20, 2007, all of which are hereby incorporated herein by reference in their entirety. TECHNICAL FIELD The present invention relates to systems and methods for removing undesirable materials from a site of interest within the circulatory system. More particularly, the present invention relates to systems and methods for removing substantially en bloc clots, thrombi, and emboli, among others, from within heart chambers, as well as medium to large vessels, while reinfusing fluid removed from the site of interest back into the patient to minimize fluid loss. BACKGROUND ART Many of the most common and deadly diseases afflicting mankind result from or in the presence of undesirable material, most notably blood clots, in the blood vessels and heart chambers. Examples of such diseases include myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, atrial fibrillation, infective endocarditis, etc. The treatment of some of these conditions, which involve smaller blood vessels, such as myocardial infarction and stroke, has been dramatically improved in recent years by targeted mechanical efforts to remove blood clots from the circulatory system. Other deadly conditions, which involve medium to large blood vessels or heart chambers, such as pulmonary embolism (½ million deaths per year) or deep venous thrombosis (2-3 million cases per year) have not benefited significantly from such an approach. Present treatment for such conditions with drugs or other interventions is not sufficiently effective. As a result, additional measures are needed to help save lives of patients suffering from these conditions. The circulatory system can be disrupted by the presence of undesirable material, most commonly blood clots, but also tumor, infective vegetations, and foreign bodies, etc. Blood clots can arise spontaneously within the blood vessel or heart chamber (thrombosis) or be carried through the circulation from a remote site and lodge in a blood vessel (thromboemboli). In the systemic circulation, this undesirable material can cause harm by obstructing a systemic artery or vein. Obstructing a systemic artery interferes with the delivery of oxygen-rich blood to organs and tissues (arterial ischemia) and can ultimately lead to tissue death or infarction. Obstructing a systemic vein interferes with the drainage of oxygen-poor blood and fluid from organs and tissues (venous congestion) resulting in swelling (edema) and can occasionally lead to tissue infarction. Many of the most common and deadly human diseases are caused by systemic arterial obstruction. The most common form of heart disease, such as myocardial infarction, results from thrombosis of a coronary artery following disruption of a cholesterol plaque. The most common causes of stroke include obstruction of a cerebral artery either from local thrombosis or thromboemboli, typically from the heart. Obstruction of the arteries to abdominal organs by thrombosis or thromboemboli can result in catastrophic organ injury, most commonly infarction of the small and large intestine. Obstruction of the arteries to the extremities by thrombosis or thromboemboli can result in gangrene. In the systemic venous circulation, undesirable material can also cause serious harm. Blood clots can develop in the large veins of the legs and pelvis, a common condition known as deep venous thrombosis (DVT). DVT arises most commonly when there is a propensity for stagnated blood (long-haul air travel, immobility) and clotting (cancer, recent surgery, especially orthopedic surgery). DVT causes harm by (1) obstructing drainage of venous blood from the legs leading to swelling, ulcers, pain and infection and (2) serving as a reservoir for blood clot to travel to other parts of the body including the heart, lungs (pulmonary embolism) and across a opening between the chambers of the heart (patent foram