US-12622714-B2 - Systems and methods for removing undesirable material within a circulatory system during a surgical procedure

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

20260512

Application Date

20251009

Claims (20)

1. 1 . A system for aspirating and filtering undesirable material from a vasculature, the system comprising: a cannula comprising a funnel shaped distal end and a lumen, the funnel shaped distal end comprising an expandable reinforcement structure and an impermeable membrane, the impermeable membrane being coupled to the expandable reinforcement structure; a pump configured to be operably coupled to the cannula, wherein the pump is configured to create a suction force sufficient to aspirate the undesirable material and blood through the cannula lumen, and the funnel distal end facilitates a vortex flow of the undesirable material and blood within the funnel shaped distal end to facilitate conforming the undesirable material into the cannula lumen; and a filter assembly configured to receive the aspirated undesirable material and blood, the filter assembly comprising an inlet, an outlet, a filter membrane, and a fluid path extending from the inlet through the filter membrane and to the outlet, wherein the filter membrane is configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the aspirated undesirable material from flowing along the fluid path from the inlet to the outlet, wherein the filter assembly includes a venting aperture configured to displace air from the filter assembly, the venting aperture being positioned above a fluid level of the filter assembly.
2. 2 . The system of claim 1 , further comprising an agitator positioned within the funnel shaped distal end to agitate the undesirable material within the funnel shaped distal end.
3. 3 . The system of claim 2 , wherein the funnel shaped distal end is configured to aspirate the undesirable material substantially en bloc.
4. 4 . The system of claim 2 , wherein: the expandable reinforcement structure is a polymer material; and the expandable reinforcement structure is balloon actuated; the expandable reinforcement structure comprises at least two strips; and the pump is an automated pump; the agitator is a balloon embolectomy catheter; the funnel shaped distal end further comprises a mechanism configured to deploy the expandable reinforcement structure; and the pump is configured to generate a drive force simultaneously with the suction force.
5. 5 . The system of claim 1 , wherein the filter assembly is configured to permit captured undesirable material to be visualized within the filter assembly.
6. 6 . The system of claim 1 , further comprising another pump, the another pump being a manually operated pump configured to flow the aspired blood and undesirable material along the fluid path within the filter assembly for a desired duration or until the filtered undesirable material has been visually confirmed within the filter assembly.
7. 7 . The system of claim 1 , wherein a diameter of the funnel shaped distal end is at least three times larger than a diameter of the cannula lumen.
8. 8 . The system of claim 1 , wherein: the expandable reinforcement structure further comprises a base and a distal most end; the impermeable membrane is configured to extend from the expandable reinforcement structure base to the expandable reinforcement structure distal most end; the funnel shaped distal end further comprises a radiopaque marker; and the impermeable membrane is coupled to either an inner surface of the expandable reinforcement structure, an outer surface of the expandable reinforcement structure, or both the inner surface and the outer surface of the expandable reinforcement structure.
9. 9 . The system of claim 1 , further comprising: a first container configured to receive the aspirated undesirable material and blood, the first container is configured to be operably coupled to the filter assembly; a second container configured to receive the aspirated blood that passed through the filter membrane, the second container is configured to be operably coupled to a reinfusion cannula configured to be placed in the vasculature; and another pump configured to be operably coupled to the reinfusion cannula and configured to generate a reinfusion force sufficient to drive the filtered blood through the reinfusion cannula into the vasculature.
10. 10 . The system of claim 9 , wherein the filter membrane further comprises a first filter material having a first pore size and a second filter material having a second pore size; the first pore size is different than the second pore size; and the first filter material and the second filter material are configured to minimize any occurrence of the aspirated undesirable material from flowing along the fluid path from the inlet to the outlet.
11. 11 . A system comprising: a cannula comprising an expandable funnel shaped distal end and a lumen, the expandable funnel shaped distal end comprising a reinforcement structure and an impermeable membrane, the impermeable membrane being coupled to the reinforcement structure, and the cannula being configured to be placed into a vasculature; a manually operated pump configured to be in fluid communication with the cannula, wherein the manually operated pump is configured to create a suction force sufficient to aspirate an undesirable material and blood through the cannula lumen; and a filter assembly configured to receive the aspirated undesirable material and blood, the filter assembly comprising an inlet, an outlet, a first filter membrane, a second filter membrane, and a fluid path extending from the inlet through the first and second filter membranes and to the outlet, wherein the second filter membrane is positioned downstream from the first filter membrane, and the first filter membrane comprises a first filter pore size and the second filter membrane comprises a second filter pore size, the first filter pore size being larger than the second filter pore size, wherein the first and second filter membranes are configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the undesirable material from flowing along the fluid path from the inlet to the outlet, and wherein the filter assembly is configured to permit the filtered undesirable material to be visualized therein.
12. 12 . The system of claim 11 , wherein: the expandable funnel shaped distal end is configured to transition from a compressed state to an expanded state; the cannula further comprises a cannula reinforcement element; the reinforcement structure is configured to withstand a negative pressure generated from the suction force and prevent the expandable funnel shaped distal end from unintentionally transitioning from the expanded state to the compressed state; and the cannula reinforcement element is configured to withstand the negative pressure generated from the suction force and prevent the cannula from collapsing.
13. 13 . The system of claim 11 , further comprising: a first container configured to receive the aspirated undesirable material and blood; a second container configured to receive the filtered blood that passed through the first and second filter membranes; and a reinfusion cannula configured to be operably coupled to the second container, placed in the vasculature, and reinfuse the filtered blood into the vasculature.
14. 14 . The system of claim 11 , wherein: the impermeable membrane is a continuous membrane extending from a base of the reinforcement structure to a distal most end of the reinforcement structure; and an inner surface of the expandable funnel shaped distal end is configured to enhance a laminar flow circumferentially along the inner surface to generate a vortex effect during the suction force.
15. 15 . The system of claim 14 , further comprising a fragmentor configured to fragment undesirable material entrapped within the expandable funnel shaped distal end and thereby enhance the suction force to aspirate the undesirable material substantially en bloc.
16. 16 . The system of claim 11 , wherein: the cannula is comprised of a pliable material and a reinforcement wire; and the cannula is configured to optimize maneuverability within the vasculature without kinking.
17. 17 . The system of claim 11 , wherein a combination of the first filter membrane and the second filter membrane is configured to result in an enhanced filtration such that substantially all of the undesirable material is filtered from the aspirated blood, thereby reducing the probability of substantially any of the undesirable material from exiting the outlet.
18. 18 . A system comprising: a cannula comprising a funnel shaped distal end and a lumen, the funnel shaped distal end comprising an expandable reinforcement structure and an impermeable membrane, the impermeable membrane being coupled to the expandable reinforcement structure; a pump configured to be operably coupled to the cannula, wherein the pump is configured to create a suction force sufficient to aspirate undesirable material and blood from a vasculature towards the cannula lumen; an agitator configured to engage with the undesirable material when positioned within the funnel shaped distal end; and a filter assembly configured to receive the aspirated undesirable material and blood, the filter assembly comprising an inlet, an outlet, a first filter membrane, a second filter membrane, and a fluid path extending from the inlet through the first and second filter membranes and to the outlet, wherein the first and second filter membranes are configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the undesirable material from flowing along the fluid path from the inlet to the outlet, wherein the second filter membrane is positioned downstream from the first filter membrane, and the first filter membrane comprises a first filter pore size and the second filter membrane comprises a second filter pore size, the first filter pore size being larger than the second filter pore size, and wherein the filter assembly further comprises a venting aperture for displacing air from the filter assembly.
19. 19 . The system of claim 18 , wherein the funnel shaped distal end and the agitator together are configured to generate a vortex effect when the suction force is applied by the pump.
20. 20 . The system of claim 18 , further comprising: a first container configured to receive the aspirated undesirable material from the cannula and operably couple to the filter assembly; a second container configured to operably couple to the filter assembly and receive the filtered blood; and a reinfusion cannula configured to operably couple to the second container, and the reinfusion cannula being configured to be placed in the vasculature, and flow the filtered blood into the vasculature.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 19/303,491 filed on Aug. 19, 2025, which 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 (