# US 11,992,195 B2 · Transfemoral transcaval liver access and devices

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- Number: US 11,992,195 B2
- Document ID: US11992195B2
- Status: Granted
- Kind: B2
- Application number: 18/045,092
- Filed: 2022-10-07
- Published: 2023-06-15
- Granted: 2024-05-28
- Earliest claimed: 2015-01-15
- Assignees: Montefiore Medical Center
- Applicants: Montefiore Medical Center
- Inventors: Jacob Cynamon; Deborah Eliana Cynamon; Yosef Golowa
- Web page: https://patentgrep.com/patent/US11992195B2

## CPC

- A61B 10/0233: {Pointed or sharp biopsy instruments}
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 2017/00946: {malleable}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Shaped liver biopsy sheaths and methods for transfemoral transcaval liver access are disclosed.

## Claims

### Claim 1

A method of obtaining a tissue sample from a liver of a patient, the method comprising:
inserting a hollow sheath through a femoral vein into a portion of the inferior vena cava (IVC) adjacent to the liver such that the hollow sheath has a tip portion positioned in the intrahepatic IVC with an opening directed toward a wall of the IVC; and
inserting the flexible biopsy needle through the hollow sheath, through the opening, through the wall of the IVC, and into the liver to obtain a tissue sample from the liver.

### Claim 2 (depends on 1)

The method of claim 1, wherein:
the method further comprises inserting an outer vascular sheath through the femoral vein into the IVC; and
after inserting the outer vascular sheath, inserting the hollow sheath through the femoral vein into the portion of the IVC adjacent via the outer vascular sheath.

### Claim 3 (depends on 1)

The method of claim 1, wherein the hollow sheath, at least when inserting the flexible biopsy needle through the hollow sheath, includes one or more bends at or proximate the tip portion such that an angle between the tip portion and a longitudinal axis of the hollow sheath directs the opening toward the wall of the IVC.

### Claim 4 (depends on 3)

The method of claim 3, wherein:
the one or more bends includes a first bend at a first location and a second bend at a second location farther from the tip portion than the first location; and
the first bend includes a radius of curvature that is lesser than a radius of curvature of the second bend.

### Claim 5 (depends on 3)

The method of claim 3, wherein the angle between the tip portion and the longitudinal axis of the hollow sheath is between 40 degrees and 80 degrees.

### Claim 6 (depends on 3)

The method of claim 3 wherein the angle between the tip portion and the longitudinal axis of the hollow sheath is between 50 degrees and 70 degrees.

### Claim 7 (depends on 3)

The method of claim 3, wherein inserting the hollow sheath includes shaping the hollow sheath in vivo such that the hollow sheath includes the one or more bends.

### Claim 8 (depends on 7)

The method of claim 7, wherein shaping the hollow sheath in vivo includes introducing the one or more bends into the hollow sheath using a mechanical handle located at an end of the hollow sheath that is positioned external to the patient.

### Claim 9 (depends on 3)

The method of claim 3, wherein the hollow sheath is preshaped to include the one or more bends prior to inserting the hollow sheath through the femoral vein into the portion of the IVC adjacent to the liver.

### Claim 10 (depends on 9)

The method of claim 9, wherein the one or more bends correspond to a metallic insert or stiffener of the hollow sheath that is precurved prior to inserting the hollow sheath through the femoral vein into the portion of the IVC adjacent to the liver.

### Claim 11 (depends on 1)

The method of claim 1, further comprising inserting a guidewire through the femoral vein into the IVC.

### Claim 12 (depends on 11)

The method of claim 11, wherein inserting the hollow sheath includes inserting, using the guidewire, the hollow sheath and a dilator positioned within the hollow sheath through the femoral vein and into the IVC.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
removing the dilator from within the hollow sheath;
inserting, through the hollow sheath, a selective catheter through the femoral vein; and
selecting a hepatic vein to measure hepatic venous pressure.

### Claim 14 (depends on 1)

The method of claim 1, further comprising obtaining the tissue sample from the liver using the flexible biopsy needle.

### Claim 15 (depends on 14)

The method of claim 14, wherein obtaining the tissue sample includes firing the flexible biopsy needle, wherein firing the flexible biopsy needle includes closing a biopsy sampling window of the flexible biopsy needle.

### Claim 16 (depends on 14)

The method of claim 14, wherein inserting the flexible biopsy needle and obtaining the tissue sample include inserting the flexible biopsy needle and obtaining the tissue sample using real-time imaging.

### Claim 17 (depends on 14)

The method of claim 14, wherein:
the tissue sample is a first tissue sample obtained at a first location in the liver; and
the method further comprises
after obtaining the first tissue sample, repositioning the flexible biopsy needle to a second location in the liver, and
obtaining, using the flexible biopsy needle, a second tissue sample from the second location in the liver.

### Claim 18 (depends on 1)

The method of claim 1, wherein inserting the hollow sheath includes inserting the hollow sheath through the femoral vein into the portion of the IVC without use of an outer vascular sheath in which the hollow sheath is positionable.

### Claim 19 (depends on 1)

The method of claim 1, wherein inserting the hollow sheath includes inserting the hollow sheath through the femoral vein into the portion of the IVC using real-time imaging.

### Claim 20 (depends on 1)

The method of claim 1, wherein inserting the flexible biopsy needle into the liver includes inserting the flexible biopsy needle directly into the liver via the IVC.
