# US 12,178,468 B2 · Excisional devices and methods

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- Number: US 12,178,468 B2
- Document ID: US12178468B2
- Status: Granted
- Kind: B2
- Application number: 18/081,298
- Filed: 2022-12-14
- Published: 2023-12-21
- Granted: 2024-12-31
- Earliest claimed: 2019-04-04
- Assignees: TransMed7, LLC
- Applicants: TransMed7, LLC
- Inventors: James W Vetter; Paul A Vetter; Eugene H Vetter
- Web page: https://patentgrep.com/patent/US12178468B2

## CPC

- A61B 17/32075: {Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque}
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0066: {Optical coherence imaging}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/4839: {combined with drug delivery}
- 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 17/22031: {Gripping instruments, e.g. forceps, for removing or smashing calculi (A61B17/221 takes precedence)}
- A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)}
- 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}
- A61B 18/245: {for removing obstructions in blood vessels or calculi}
- A61B 2017/00061: {spectrum}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/22061: {for spreading elements apart}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2017/22071: {Steering}
- A61B 2017/22079: {with suction of debris}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61B 2017/320716: {comprising means for preventing embolism by dislodged material}
- A61B 2017/320766: {eccentric}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/00202: {rotating}
- A61B 2018/0041: {Removal of thrombosis}
- A61B 2018/00422: {Angioplasty}
- A61B 2018/00577: {Ablation}
- A61B 2018/00601: {Cutting}
- A61B 2018/00625: {Vaporization}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00785: {Reflected power}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/208: {with multiple treatment beams not sharing a common path, e.g. non-axial or parallel}
- A61B 2018/2211: {Plurality of fibres}
- A61B 2090/3735: {Optical coherence tomography [OCT]}
- A61B 2090/3784: {both receiver and transmitter being in the instrument or receiver being also transmitter}
- A61B 2217/005: with suction drainage system
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A platform device for material excision or removal from vascular structures for either handheld or stereotactic table or robotics platform use may comprise a work element or elements configured to selectively open and close at least one articulable beak or scoopula configured to penetrate and remove intra-vascular materials or obstructions or follow a central lumen of another device or over a wire in a longitudinal direction. Flush and vacuum tissue transport mechanisms may be incorporated as well as single or multiple arrays of image guidance elements, directional elements, ablation elements and other interventional assistance elements. A single tube or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks or scoopulas and provisions for simultaneous or differential beak or scoopula closing under their differential rotation may be incorporated.

## Claims

### Claim 1

A method, comprising:
advancing a device within a vasculature to a target region, the device comprising a scoopula comprising an open side portion, a first pair of rotatable first and second articulable beaks that partially extend into the open portion of the scoopula, at least one inflatable support element attached near a distal end of an outer surface of the scoopula and an expandable and collapsible cutting and imaging chamber disposed at a distal end of a central tube coaxially disposed between the first pair of rotatable first and second articulable beaks;
inflating the chamber and at least one inflatable support element such that the chamber is pressed against a surface of the vasculature distal to the target region;
imaging the vasculature using the chamber;
rotating the first pair of first and second articulable beaks; and
cutting tissue that comes into contact with the rotating first pair of first and second articulable beaks within the open side portion of the scoopula to a selectable depth that is at least partially dependent on the inflation of at least one of the chamber and of the at least one inflatable support element.

### Claim 2 (depends on 1)

The method of claim 1, wherein the chamber further comprises a plurality of curved blades disposed on a portion of an outer surface of the chamber that faces the first pair of first and second articulable beaks, and wherein the method further bringing the first pair of first and second articulable beaks into contact with the plurality of curved blades to part off tissue cut by the rotating first pair of first and second articulable beaks.

### Claim 3 (depends on 1)

The method of claim 1, wherein advancing is performed over a guidewire inserted within the vasculature.

### Claim 4 (depends on 1)

The method of claim 1, wherein the imaging is performed using optical coherence tomography.

### Claim 5 (depends on 1)

The method of claim 1, wherein the imaging is performed using ultrasound.

### Claim 6 (depends on 1)

The method of claim 1, wherein the device further comprises an independently operable second pair of first and second articulable beaks that is smaller than the first pair of first and second articulable beaks and wherein the chamber is further configured to define a central lumen that emerges at a distal end of the chamber, and wherein the method further comprises advancing the second pair of first and second articulable beaks through the central lumen past the distal end of the chamber.

### Claim 7 (depends on 6)

The method of claim 6, further comprising coring through tissue disposed distal to the chamber with the second pair of the first and second articulable beaks rotating in an open configuration and parting off the cored tissue by causing the second pair of the first and second articulable beaks to assume a closed configuration.

### Claim 8 (depends on 7)

The method of claim 7, further comprising stabilizing the coring and parting off of the tissue distal to the chamber by controlling inflation of the chamber and of the at least one inflatable support element.

### Claim 9 (depends on 7)

The method of claim 7, further comprising deflating the chamber and advancing the chamber within a cored path created by the second pair of the first and second articulable beaks.

### Claim 10 (depends on 9)

The method of claim 9, further comprising re-inflating the chamber within the cored path created by the second pair of the first and second articulable beaks.

### Claim 11 (depends on 1)

The method of claim 1, further comprising inflating an expandable cuff disposed proximal of the first pair of first and second articulable beaks.

### Claim 12 (depends on 1)

The method of claim 1, wherein the at least one inflatable support element comprises a first inflatable support element and a second inflatable support element spaced apart from the first inflatable support element to define a channel therebetween and wherein the method further comprises enabling fluid flow from a distal end of the device downstream past a proximal end of the device through the channel.

### Claim 13 (depends on 1)

The method of claim 1, further comprising selectably deforming the chamber against one side of a passageway by inflating the at least one inflatable support element to press against an opposing side of the passageway.