# US 10,307,242 B2 · Simultaneous rotating separator, irrigator microcatheter for thrombectomy and method of use

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- Number: US 10,307,242 B2
- Document ID: US10307242B2
- Status: Granted
- Kind: B2
- Application number: 16/125,691
- Filed: 2018-09-08
- Published: 2019-01-31
- Granted: 2019-06-04
- Earliest claimed: 2016-09-07
- Applicants: Daniel Ezra Walzman
- Inventors: Daniel Ezra Walzman
- Web page: https://patentgrep.com/patent/US10307242B2

## CPC

- A61F 2/013: {Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting}
- A61B 8/06: Measuring blood flow
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61B 17/32037: {for removing obstructions from inner organs or blood vessels, e.g. for atherectomy}
- A61B 17/3207: Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)}
- A61B 17/320758: {with a rotating cutting instrument, e.g. motor driven (A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002)}
- A61B 17/320783: {through side-hole, e.g. sliding or rotating cutter inside catheter}
- A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 2017/00876: {magnetic}
- A61B 2017/00955: {thermoplastic}
- A61B 2017/22039: {eccentric}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22079: {with suction of debris}
- A61B 2017/320716: {comprising means for preventing embolism by dislodged material}
- A61B 2017/320733: {with a flexible cutting or scraping element, e.g. with a whip-like distal filament member}
- A61B 2017/320775: {Morcellators, impeller or propeller like means}
- A61B 2090/3784: {both receiver and transmitter being in the instrument or receiver being also transmitter}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61F 2/011: {Instruments for their placement or removal}
- A61F 2002/018: {made from tubes or sheets of material, e.g. by etching or laser-cutting}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The described invention provides several aspects designed to help mechanically break up a clot inside vessels and/or remove a clot via aspiration simultaneously, and a method of using same. According to some embodiments, the devices are adapted to irrigate a blood vessel during thrombectomy; to macerate an obstruction during thrombectomy, to block blood flow in a blood vessel during aspiration of a thrombus; or to capture and remove distal emboli. With the described invention, when used to ameliorate arterial clots, irrigation and aspiration are performed simultaneously in conjunction with a balloon or occlusive catheter to reverse flow of the vessel. With the described invention, when used to ameliorate venous clots and most arteriovenous dialysis grafts, a filter-tipped aspirator is used downstream from the clot to capture and remove dislocated emboli. An optional embodiment protects the three Great Vessels of the heart, unlike the prior art.

## Claims

### Claim 1

An endovascular device for protecting the three great vessels of the aortic arch and the outflow to the descending aorta simultaneously by capturing and removing emboli comprising:
an aspiration catheter comprising a proximal end, a wall that comprises a circumference and that spans the proximal end to a distal end, wherein the wall of the aspiration catheter defines a luminal space, a first opening at the proximal end of the aspiration catheter, and a second opening at the distal end of the aspiration catheter;
a central tube disposed within the luminal space of the aspiration catheter, the central tube comprising a proximal end, a wall that comprises a circumference and that spans from the proximal end to a distal end, wherein the wall of said central tube defines a luminal space, a first opening at the proximal end of said central tube, and a second opening at the distal end of said central tube;
a retaining structure connected to the distal end of said central tube and extending in a direction from the distal end to the proximal end of said central tube, said retaining structure adapted to resist deformation, wherein a width of said retaining structure is less than a diameter of the luminal space defined by the aspiration catheter;
wherein said retaining structure has at least one bend;
at least one flared, semi-permeable filter adapted to allow passage of blood cells and serum and to capture emboli, said at least one semi-permeable filter directly attached to the distal end of the aspiration catheter,
wherein when said at least one semi-permeable filter is disposed between one or more said retaining structure and said central tube, said at least one semi-permeable filter is confined to a folded shape having a width less than the diameter of the luminal space defined by the aspiration catheter;
wherein when said at least one semi-permeable filter is not disposed between the one or more retaining structures, said at least one semi-permeable filter comprises a flared shape with a width greater than the diameter of the aspiration catheter, and is adapted to capture emboli and direct emboli toward the second opening of the aspiration catheter for removal through the luminal space of the aspiration catheter.

### Claim 2 (depends on 1)

The device of claim 1, wherein said at least one filter comprises a membrane with pores.

### Claim 3 (depends on 2)

The device of claim 2, wherein said pores are differentially sized, having approximately half at 1 μm-250 μm and half at 0.1 μm-5 mm.

### Claim 4 (depends on 1)

The device of claim 1, wherein said at least one filter is supported by rigid wires.

### Claim 5 (depends on 4)

The device of claim 4, wherein said wires are nitinol.

### Claim 6 (depends on 1)

The device of claim 1, wherein hydrogel is disposed upon the peripheral edges of said at least one filter.

### Claim 7 (depends on 1)

A method of using the endovascular device of claim 1 for protecting flow through the ascending aorta, comprising the steps of:
(a) inserting said device via a femoral artery,
(b) passing distal end of said device over the aortic arch,
(c) positioning said distal end of said device such that said at least one filter faces the aortic valve within the ascending aorta between the heart and innominate artery;
(d) deploying said filter by advancing said central tube;
(e) removing said central tube;
(f) allowing the lumen of said catheter to transmit additional interventional tools and devices through said filter without displacing said filter.

### Claim 8

An endovascular device for protecting output of the ascending aorta by capturing and removing emboli comprising:
a catheter comprising a proximal end, a wall that comprises a circumference and that spans the proximal end to a distal end, wherein the wall of said catheter defines a luminal space, a first opening at the proximal end of said catheter, and a second opening at the distal end of said catheter;
a central tube disposed within the luminal space of said catheter, the central tube comprising a proximal end, a wall that comprises a circumference and that spans from the proximal end to a distal end, wherein the wall of said central tube defines a luminal space, a first opening at the proximal end of said central tube, and a second opening at the distal end of said central tube;
a retaining structure connected to the distal end of said central tube and extending in a direction from the distal end to the proximal end of said central tube, said retaining structure adapted to resist deformation, wherein a width of said retaining structure is less than a diameter of the luminal space defined by the catheter;
at least one flared, semi-permeable filter adapted to allow passage of blood cells and serum and to capture emboli, said at least one semi-permeable filter directly attached to the distal end of the catheter,
wherein when said at least one semi-permeable filter is disposed between one or more said retaining structure and said central tube, said at least one semi-permeable filter is confined to a folded shape having a width less than the diameter of the luminal space defined by said catheter;
wherein when said at least one semi-permeable filter is not disposed between the one or more retaining structures, said at least one semi-permeable filter comprises a flared shape with a width greater than the diameter of said catheter, and is adapted to capture emboli and direct emboli toward the second opening of said catheter for optional removal through the luminal space of said catheter.

### Claim 9 (depends on 8)

The device of claim 8, wherein said at least one filter comprises a membrane with pores.

### Claim 10 (depends on 9)

The device of claim 9, wherein said pores are differentially sized, having approximately half at 1 μm-250 μm and half at 0.1 μm-5 mm.

### Claim 11 (depends on 8)

The device of claim 8, wherein said at least one filter is supported by rigid wires.

### Claim 12 (depends on 11)

The device of claim 11, wherein said wires are nitinol.

### Claim 13 (depends on 8)

The device of claim 8, wherein hydrogel is disposed upon the peripheral edges of said at least one filter.
