# US 10,912,542 B2 · Catheter assembly with offset device for tissue sampling > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,912,542 B2 - Document ID: US10912542B2 - Status: Granted - Kind: B2 - Application number: 15/933,372 - Filed: 2018-03-22 - Published: 2019-09-19 - Granted: 2021-02-09 - Earliest claimed: 2018-03-14 - Assignees: Spiration, Inc. - Applicants: Spiration, Inc. - Inventors: Madeline C. Graham; Matthew E. Nickeson - Web page: https://patentgrep.com/patent/US10912542B2 ## CPC - A61B 10/0233: {Pointed or sharp biopsy instruments} - A61B 10/0283: {with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe (A61B10/025, A61B10/0266 take precedence)} - A61B 10/04: Endoscopic instruments, e.g. catheter-type instruments - A61B 2010/045: {Needles (pointed biopsy devices with vacuum aspiration A61B10/0283)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Disclosed embodiments include catheter assemblies, systems for sampling a targeted region of tissue, and methods of sampling a targeted region of tissue. In an illustrative, non-limiting embodiment, a catheter assembly includes: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; and a curved flexible needle disposable in the lumen and being extendable from the opening at the distal end of the catheter at an angle that diverges from an axis of the lumen. ## Claims ### Claim 1 A catheter assembly comprising: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; a curved flexible needle disposable in the lumen and being extendable from the opening at the distal end of the catheter at an angle that diverges from an axis of the lumen; and a straight stylet coaxially disposable within the curved flexible needle as the curved flexible needle is extended beyond the opening at the distal end of the catheter and to cause the curved flexible needle to conform to a shape of the straight stylet to limit the angle at which the curved flexible needle diverges from the axis of the lumen as the curved flexible needle is extended beyond the opening at the distal end of the catheter. ### Claim 2 (depends on 1) The catheter assembly of claim 1, wherein the curved flexible needle is configured to conform to a shape of the catheter while disposed within the lumen. ### Claim 3 (depends on 1) The catheter assembly of claim 1, wherein the curved flexible needle is made from a shape memory alloy. ### Claim 4 (depends on 1) The catheter assembly of claim 1, further comprising a ramp defined in the catheter at the distal end of the catheter, the ramp having a sloped surface that is divergent with the axis of the lumen and configured to deflect the flexible curved needle at an offset from the axis of the lumen. ### Claim 5 (depends on 4) The catheter assembly of claim 4, wherein the ramp defines the offset from the axis of the lumen in a range of around 5 degrees to around 25 degrees. ### Claim 6 (depends on 1) The catheter assembly of claim 1, wherein a degree to which the curved flexible needle conforms to the shape of the straight stylet is proportional to a distance the straight stylet extends toward a tip of the needle. ### Claim 7 (depends on 1) The catheter assembly of claim 1, wherein the straight stylet is further configured to be withdrawn from the lumen. ### Claim 8 A system for sampling a targeted region of tissue, the system comprising: a handle assembly; and a catheter assembly operably coupled to the handle assembly, the catheter assembly being configured to be insertable into a bodily lumen toward a targeted region of tissue to be sampled, the catheter assembly including: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; and a curved flexible needle disposable in the lumen and being extendable from the opening at the distal end of the catheter into a tissue including the targeted region of tissue to be sampled, wherein the curved flexible needle is extendable at an angle that diverges from an axis of the lumen; and a straight stylet coaxially disposable within the curved flexible needle as the curved flexible needle is extended beyond the opening at the distal end of the catheter and configured to cause the curved flexible needle to conform to a shape of the straight stylet to limit the angle at which the curved flexible needle diverges from the axis of the lumen as the curved flexible needle is extended beyond the opening at the distal end of the catheter. ### Claim 9 (depends on 8) The system of claim 8, further comprising a ramp defined in the catheter at the distal end of the catheter, the ramp having a sloped surface that is divergent with the axis of the lumen and configured to deflect the flexible curved needle at an offset from the axis of the lumen. ### Claim 10 (depends on 8) The system of claim 8, wherein the stylet is further configured to be withdrawn from the lumen with the handle assembly, the system further comprising: a vacuum device operatively couplable to the needle via the handle assembly with the stylet withdrawn from the lumen. ### Claim 11 (depends on 8) The system of claim 8, wherein the handle assembly is configured to torque the catheter. ### Claim 12 A method for sampling a targeted region of tissue, the method comprising: inserting a catheter in a bodily lumen toward a targeted region of tissue to be sampled; extending a curved flexible needle from a distal end of the catheter at an angle that diverges from an axis of the catheter toward the targeted region of tissue to be sampled; moving a straight stylet coaxially disposable within the curved flexible needle to a distance up to at least a tip of the curved flexible needle as the curved flexible needle is extended beyond the distal end of the catheter, wherein moving the straight stylet toward the tip of the curved needle causes the curved flexible needle to conform to a shape of the straight stylet to limit the angle at which the tip of the curved flexible needle diverges from the axis of the catheter; penetrating the tissue with the needle; and sampling the tissue. ### Claim 13 (depends on 12) The method of claim 12, further comprising controlling the angle at which the curved flexible needle diverges from the axis of the catheter by extending the curved flexible needle over a ramp defined in the catheter at the distal end of the catheter, the ramp having a sloped surface that is divergent with the axis of the catheter. ### Claim 14 (depends on 12) The method of claim 12, further comprising: after inserting the catheter in the bodily lumen toward the targeted region of tissue to be sampled and before extending the curved flexible needle from the distal end of the catheter at the angle that diverges from the axis of the catheter toward the targeted region of tissue to be sampled, torqueing the catheter such that the opening defined in the distal end of the catheter is oriented toward the targeted region of tissue to be sampled.