IP Library › Granted Patent US 12,251,129
Granted Patent B1
US 12,251,129 · App. 18/907,913 · Granted Mar 18, 2025

Transperineal biopsy guide with access needle support structure supporting an access needle at various vertical positions within a vertical opening of the guide

Inventor: Matthew J. Allaway (Cumberland, MD)
Assignee: Corbin Clinical Resources, LLC
A61B17/3403A61B8/0841A61B8/12A61B10/0241A61B10/04A61B90/39A61B2010/045A61B2017/00274A61B2017/00477A61B2017/3405A61B2017/3411A61B2017/3413A61B2018/00547A61B18/02A61B18/12A61B2090/3925A61B2090/3933A61B2090/3954A61B2090/3966
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Quick Facts
Patent No.
US 12,251,129
App. No.
18/907,913
Granted
Mar 18, 2025
Kind
B1
Abstract

A transperineal biopsy guide configured for use with an access needle and a transrectal imaging probe. The transperineal biopsy guide may include a mount attachable to the transrectal imaging probe and an upper assembly. The upper assembly may extend from the mount and may include a vertical opening, at least one distal member, and an access needle support structure. The access needle support structure is aligned with the vertical opening and supports the access needle at a plurality of discrete vertical positions within the vertical opening relative to the transrectal imaging probe. The access needle support structure is displaceable relative to the at least one distal member. And the at least one distal member limits distal displacement of the access needle support structure relative to the at least one distal member.

Claims (36)

1. A transperineal biopsy guide configured for use with an access needle and a transrectal imaging probe adjacent a patient's perineum, the access needle including a proximal end hub, a distal sharp end opposite the proximal end hub and a longitudinal axis extending between the proximal end hub and the distal sharp end, the access needle sized to receive a biopsy instrument therethrough, the transrectal imaging probe including a proximal end, a distal end and a longitudinal axis extending between the proximal end and the distal end, the transrectal imaging probe configured to provide imaging in an imaging plane of the transrectal imaging probe, the transperineal biopsy guide comprising:

a mount attachable to the transrectal imaging probe between the proximal and distal ends of the transrectal imaging probe; and

an upper assembly extending from the mount and including:

a vertical opening;

at least one distal member laterally bordering the vertical opening, the at least one distal member comprising a first distal member comprising a first distal-facing surface; and

an access needle support structure aligned with the vertical opening and configured to support the access needle at a plurality of discrete vertical positions within the vertical opening relative to the transrectal imaging probe when the mount is attached to the transrectal imaging probe and the access needle is supported by the access needle support structure,

wherein the access needle support structure is displaceable relative to the at least one distal member, and wherein the at least one distal member limits distal displacement of the access needle support structure relative to the at least one distal member.

2. The transperineal biopsy guide of claim 1 , wherein the at least one distal member further comprises a second distal member comprising a second distal-facing surface, the vertical opening being defined between the first distal member and the second distal member.

3. The transperineal biopsy guide of claim 2 , wherein the first distal member further comprises a first proximal-facing surface opposite the first distal-facing surface, and the second distal member further comprises a second proximal-facing surface opposite the second distal-facing surface, and wherein distal displacement of the access needle support structure relative to the at least one distal member is limited by the access needle support structure contacting the first proximal-facing surface and the second proximal facing surface.

4. The transperineal biopsy guide of claim 2 , wherein the first distal-facing surface and the second distal-facing surface are planar.

5. The transperineal biopsy guide of claim 2 , wherein the access needle support structure is displaceable proximally-distally relative to the first distal member and the second distal member.

6. The transperineal biopsy guide of claim 5 , wherein, in being displaceable proximally-distally relative to the first distal member and the second distal member, the access needle support structure is moveable into and out of the vertical opening.

7. The transperineal biopsy guide of claim 5 , wherein the access needle support structure is securable in a distal position relative to the first distal member and the second distal member.

8. The transperineal biopsy guide of claim 7 , wherein the first distal member further comprises a first proximal-facing surface opposite the first distal-facing surface, and the second distal member further comprises a second proximal-facing surface opposite the second distal-facing surface, and wherein, in being securable in the distal position, a first portion of the access needle support structure abuts or is adjacent the first proximal-facing surface and a second portion of the access needle support structure abuts or is adjacent the second proximal-facing surface.

9. The transperineal biopsy guide of claim 8 , wherein the upper assembly further includes a first ramped surface and a second ramped surface, the first ramped surface spaced apart from the first proximal-facing surface, the second ramped surface spaced apart from the second proximal-facing surface, and wherein, in being securable in the distal position, the first portion of the access needle support structure is positioned at least partially between the first proximal-facing surface and the first ramped surface and the second portion of the access needle support structure is positioned at least partially between the second proximal-facing surface and the second ramped surface.

10. The transperineal biopsy guide of claim 1 , wherein the vertical opening is in a fixed position relative to the transrectal imaging probe when the mount is attached to the transrectal imaging probe.

11. The transperineal biopsy guide of claim 1 , wherein the access needle support structure includes at least one passage through which the access needle extends to pass through the vertical opening.

12. The transperineal biopsy guide of claim 11 , wherein the at least one passage is configured to support the access needle at one of the pluralities of discrete vertical positions within the opening.

13. The transperineal biopsy guide of claim 12 , wherein the at least one passage comprises multiple passages stacked in an evenly spaced arrangement.

14. The transperineal biopsy guide of claim 1 , wherein at least a portion of the upper assembly is distally cantilevered relative to a portion of the mount that extends around the transrectal imaging probe when the mount is attached to the transrectal imaging probe.

15. The transperineal biopsy guide of claim 1 , wherein the access needle is configured to be supported at the plurality of discrete vertical positions within the vertical opening via a plurality of vertically dispersed evenly spaced-apart receiving structures of the upper assembly.

16. The transperineal biopsy guide of claim 15 , wherein the plurality of vertically dispersed evenly spaced-apart receiving structures is a plurality of vertically dispersed evenly spaced-apart passages of the access needle support structure, each of the plurality of vertically dispersed evenly spaced-apart passages configured to receive the access needle.

17. The transperineal biopsy guide of claim 1 , wherein the access needle support structure can be distally displaced relative to the at least one distal member to cause the access needle to at least one of enter, or become increasingly distally extended through, the vertical opening.

18. The transperineal biopsy guide of claim 17 , wherein the distal displacement of the access needle support structure relative to the at least one distal member causes the access needle to be at least one of positioned, or increasingly positioned, within the imaging plane when the access needle is supported by the access needle support structure and the mount is attached to the transrectal imaging probe.

19. The transperineal biopsy guide of claim 17 , wherein distally displacing the access needle support structure causes the access needle support structure to move into the vertical opening.

20. The transperineal biopsy guide of claim 17 , wherein the upper assembly further includes a stop feature and distally displacing the access needle support structure causes a portion of the access needle support structure to be engaged by the stop feature, thereby holding the access needle support structure in a distal position relative to the vertical opening.

21. The transperineal biopsy guide of claim 20 , wherein the stop feature is a fixed proximal distance from a proximal facing-surface of the at least one distal member.

22. The transperineal biopsy guide of claim 17 , wherein the upper assembly further includes a ramp feature having an apex, wherein distally displacing the access needle support structure causes a portion of the access needle support structure to ride up and over the ramp feature, wherein when the portion of the access needle support structure has distally passed the apex of the ramp feature, the access needle support structure is held by the ramp feature in the distal position of the access needle support structure relative to the distal-facing vertical opening.

23. The transperineal biopsy guide of claim 22 , wherein the ramp feature distally slopes upward until the apex, at which point the ramp distally slopes downward, the portion of the access needle support structure being distal the apex when the access needle support structure is held by the ramp feature in the distal position of the access needle support structure relative to the distal facing vertical opening.

24. The transperineal biopsy guide of claim 17 , wherein the upper assembly further includes spaced-apart lateral sidewalls defining a channel therebetween, the channel extending distal-proximal and aligning with the vertical opening, the access needle support structure having opposite lateral sides that displace along the lateral sidewalls when the access needle support structure is distally displaced relative to the at least one distal-facing surface.

25. The transperineal biopsy guide of claim 24 , wherein at least one of the spaced-apart lateral sidewalls and at least one of the opposite lateral sides have a complementary mechanically meshed interface with each other that allows the at least one of the opposite lateral sides to slide along the at least one of the spaced-apart lateral sidewalls.

26. The transperineal biopsy guide of claim 25 , wherein the complementary mechanically meshed interface includes a male linearly extending member slidably received within a female linearly extending recess.

27. The transperineal biopsy guide of claim 26 , wherein the male linearly extending member is part of the at least one of the opposite lateral sides, and the female linearly extending recess is defined in the at least one of the spaced-apart lateral sidewalls.

28. The transperineal biopsy guide of claim 1 , wherein, when the mount is attached to the transrectal imaging probe and the access needle is supported by the access needle support structure and passes through the vertical opening, at least a distal region of the access needle is positioned within the imaging plane.

29. The transperineal biopsy guide of claim 1 , further comprising the access needle.

30. The transperineal biopsy guide of claim 29 , wherein a proximal-facing side of the access needle support structure includes a recess aligned with a passage for receiving the access needle, the proximal end hub of the access needle and the recess including complementary surfaces that inhibit rotation of the access needle within the passage.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 10, 2026
From: CORBIN CLINICAL RESOURCES, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 075734/0844 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 10, 2026
From: CORBIN CLINICAL RESOURCES, LLC
To: CORBIN CLINICAL RESOURCES, INC.
Reel/Frame 075833/0246 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2024
From: ALLAWAY, MATTHEW J.
To: CORBIN CLINICAL RESOURCES, LLC
Reel/Frame 068848/0274 →
Continuity (10)
Continuation 18094534 · Jan 9, 2023
Continuation 17698641 · Mar 18, 2022
Continuation 17494962 · Oct 6, 2021
Continuation In Part 17314845 · May 7, 2021
Continuation In Part 16991150 · Aug 12, 2020
Continuation 16115180 · Aug 28, 2018
Continuation 14874104 · Oct 2, 2015
Continuation 14677286 · Apr 2, 2015
Continuation In Part 14677286 · Apr 2, 2015
Provisional Application 61974826 · Apr 3, 2014
References Cited (30)
US 4735215A · Goto et al. · 1988 [cited by applicant]
US 5161542A · Palestrant · 1992 [cited by applicant]
US 8057432B2 · Flagle et al. · 2011 [cited by applicant]
Eldred-Evans D., et al., “The Use of Transperineal Sector Biopsy as A First-Line Biopsy Strategy: A Multi-Institutional Analysis of Clinical Outcomes and Complications,” Urological Oncology, Exhibit 2015, Jun. 2016, 7 p… [cited by applicant]
EPO, Submission in Opposition Proceedings of EP3827779 Opponent: JA Kemp, Aug. 23, 2024, 100 pages. [cited by applicant]
Exhibit 2012 to Reply to Non-Final Office Action in Ex-Parte Re-Examination 90/019,257 dated Aug. 12, 2024, Expert Declaration of Dr. Rick Popert. [cited by applicant]
Exhibit 2013 to Reply to Non-Final Office Action in Ex-Parte Re-Exam 90/019,257 dated Aug. 12, 2024, CV of Dr. Rick Popert, MS (Lond). [cited by applicant]
Expert Declaration of Dr. Abhinav Sidana, dated Nov. 13, 2024, 42 pgs. [cited by applicant]
Expert Declaration of Dr. Abhinav Sidana, dated Dec. 9, 2024, 40 pgs. [cited by applicant]
Final Office Action in Re-Exam 90019257, dated Sep. 10, 2024, 34 pgs. [cited by applicant]
Gazelle G.S., et al., “Guided Percutaneous Biopsy of Intraabdominal Lesions,” American Journal of Roentgenology, Nov. 1, 1989, vol. 153, No. 5, pp. 929-935. [cited by applicant]
Hopper K.D., et al., “Multiple Fine-Needle Biopsies using a Coaxial Technique: Efficacy and a Comparison of Three Methods,” CardioVascular and Interventional Radiology, Sep. 1995, vol. 18, pp. 307-311. [cited by applicant]
Jones U.S., “Prostate Biopsy—Indications, Techniques and Complications,” Springer, 2008, 23 pages. [cited by applicant]
Kum F., et al., “Initial Outcomes of Local Anaesthetic Freehand Transperineal Prostate Biopsies in the Outpatient Setting,” Urological Oncology, Exhibit 2017, 2017, 26 pages. [cited by applicant]
MDL, “SemiCut,” MDL Catalog, Oct. 5, 2013, 1 page, Retrieved from the Internet: URL: https://pdf.medicalexpo.com/pdf/mdl/semicut/84369-100157.html. [cited by applicant]
Notice of Allowance, U.S. Appl. No. 18/908,020, dated Nov. 27, 2024, 7 pgs. [cited by applicant]
Office Action in Ex Parte Re-Exam 90019257, dated Oct. 28, 2024, 20 pgs. [cited by applicant]
Office Action in Ex Parte Re-Exam 90019335, dated Sep. 10, 2024, 26 pgs. [cited by applicant]
Office Action in Ex Parte Re-Exam 90019354, dated Aug. 14, 2024, 15 pgs. [cited by applicant]
Office Action in Ex Parte Re-Exam 90019372, dated Sep. 19, 2024, 31 pgs. [cited by applicant]
Parker S.H., et al., “Image-Directed Percutaneous Biopsies with a Biopsy Gun,” Radiology, Jun. 1, 1989, vol. 171, No. 03, pp. 663-669. [cited by applicant]
Reply to Final Office Action for Ex-Parte Reexamination 90019257 , dated Oct. 3, 2024, 16 pgs. [cited by applicant]
Reply to Non-Final Office Action for Ex-Parte Reexamination 90019335, dated Dec. 10, 2024, 66 pgs. [cited by applicant]
Reply to Non-Final Office Action for Ex-Parte Reexamination 90019354 , dated Nov. 14, 2024, 66 pgs. [cited by applicant]
Request for Ex Parte Reexamination of U.S. Pat. No. 11,547,436, dated Sep. 20, 2024, 74 pages. [cited by applicant]
Smith J.B., et al., “Transperineal Sector Prostate Biopsies: A Local Anesthetic Outpatient Technique,” Oncology, Exhibit 2016, 2014, 6 pages. [cited by applicant]
Stroman L., et al., “A Cross-section of UK Prostate Cancer Diagnostics During the Coronavirus Disease 2019 (Covid-19) Era—A Shifting Paradigm,” BJU International, Exhibit 2019, 2021, vol. 127, pp. 30-34. [cited by applicant]
Supplemental Response to Non-Final Office Action for Ex-Parte Reexamination 90/019,257, dated Aug. 12, 2024, 11 pages. [cited by applicant]
Tamhankar A.S., et al., “The Clinical and Financial Implications of a Decade of Prostate Biopsies in the NHS: Analysis of Hospital Episode Statistics Data 2008-2019,” BJU International, Exhibit 2018, 2020, 9 pages. [cited by applicant]
Vyas L., et al., “Indications, Results and Safety Profile of Transperineal Sector Biopsies (TPSB) Of the Prostate: A Single Centre Experience of 634 Cases,” NHS Foundation Trust, 2014, Exhibit 2014, 22 pages. [cited by applicant]