Source: https://patents.google.com/patent/US10052091B2/en
Timestamp: 2019-04-24 07:18:12+00:00

Document:
2013-01-17 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40568219&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US10052091(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
2016-01-14 Assigned to ARTHREX, INC. reassignment ARTHREX, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BURKHART, STEPHEN S., ELATTRACHE, NEIL S.
A method for securing soft tissue to bone which does not require the surgeon to tie suture knots to secure the tissue to the bone. Suture is passed through the tissue at desired points. A cannulated plug or screw is pre-loaded onto the distal end of a driver provided with an eyelet implant at its distal end. Suture attached to the tissue is passed through the eyelet of the implant located at the distal end of the driver. The distal end of the driver together with the eyelet implant is inserted into the bone. Tension is applied to the suture to position the tissue at the desired location relative to the bone. The screw or plug is advanced into the pilot hole by turning the interference screw or tapping the plug until the cannulated screw or plug securely engages and locks in the eyelet implant, so that the cannulated plug or screw with the engaged eyelet implant is flush with the bone. Once the screw or plug is fully inserted and the suture is secured in the bone, the driver is removed and any loose ends of the sutures protruding from the anchor site are then clipped short.
This is a divisional of U.S. application Ser. No. 13/182,893, filed Jul. 14, 2011, now U.S. Pat. No. 8,430,909, which is a continuation of U.S. application Ser. No. 12/022,868, filed Jan. 30, 2008, now U.S. Pat. No. 7,993,369, which is a continuation-in-part of U.S. application Ser. No. 10/405,707, filed Apr. 3, 2003, now U.S. Pat. No. 7,329,272, which is a continuation-in-part of U.S. application Ser. No. 09/886,280, filed Jun. 22, 2001, now U.S. Pat. No. 6,544,281, which claims the benefit of U.S. Provisional Application No. 60/213,263, filed Jun. 22, 2000.
FIGS. 15 and 15A are schematic views of the surgical site of FIG. 13 at a graft fixation stage subsequent to that shown in FIGS. 14 and 14A.
A significant advantage of the present invention is that the sutures attached to the graft or the graft itself can be securely attached to the bone without the need to tie knots. Additionally, the suture attached to the graft is secured both by the eyelet implant and by the interference device, along the bottom and sidewalls of the pilot hole between the bone and the screw or plug, conferring a much stronger fixation of the graft to the bone than is achievable with prior art procedures and devices. More importantly, the suture attached to the graft is allowed to freely slide though the aperture of the eyelet implant to allow precise advancement and guiding of the plug or screw into the blind hole or socket.
Referring to FIG. 13, an Arthrex SutureBridge ® medial row is completed as known in the art and the strands 80 (suture strands 80) are threaded through the titanium eyelet 455. As shown in FIGS. 14A, a protective cap 94 (or other device that prevents anchor deployment) is malleted to advance the PUSHLOCK® until the anchor contacts bone 93. The suture is then tensioned, as shown in FIG. 14. The protective cap 94 is subsequently removed (FIG. 15A) and the button 420 is malleted until mark (for example, a predefined laser line) is flush with the bone (FIG. 15). The ribbed, spiked configuration of plug or button 420 facilitates the insertion of the device 400 into the bone by simply exerting force upon the device, without the need to drill or form a hole in the bone.
wherein the driver includes a handle near the proximal end of the shaft, a portion of the handle being configured to be malleted to advance the implant in an insertion direction into bone without predrilling a hole in the bone and wherein the handle is manipulatable to advance the interference device in the insertion direction toward the implant into a suture securing position where the interference device secures the suture in the bone.
2. The system of claim 1, wherein the interference device is a screw.
3. The system of claim 1, wherein the interference device is a plug.
4. The system of claim 1, wherein the aperture of the implant has an eyelet configuration.
the implant is releasably attached to the inner shaft by a connector portion of the implant that fits within the distal end of the inner shaft.
the handle is manipulatable to cause the outer shaft to advance from the proximal position to the distal position to advance the interference device toward the implant.
7. The system of claim 1, wherein the driver is useable in a first mode for urging the implant into bone and in a second mode for urging the interference device into bone.
8. The system of claim 1, wherein the interference device wedges suture between the interference device and bone.
9. The system of claim 1, wherein the interference device wedges suture in place to secure the suture without tying any knots.
the spacing is determined between the proximal end of the conical portion and the interference device.
wherein a portion of the handle is configured to be malleted to advance the implant in the insertion direction into bone without predrilling a hole in the bone and the handle is manipulatable to advance the suture anchor in the insertion direction toward the implant into a suture securing position where the suture anchor secures the suture in the bone.
the suture anchor wedges suture in place relative to bone resulting from the driver causing the suture anchor to move away from the proximal end toward the aperture of the implant.
13. The surgical device of claim 11, wherein the suture anchor wedges suture between the suture anchor and bone.
14. The surgical device of claim 11, wherein the suture anchor comprises a screw.
15. The surgical device of claim 11, wherein the suture anchor comprises a plug.
16. The surgical device of claim 11, wherein the aperture of the implant has an eyelet configuration.
the implant is releasably attached to the inner shaft by a connector portion of the implant that fits within a tubing near the distal end of the inner shaft.
18. The surgical device of claim 11, wherein the shaft includes an outer shaft disposed around an inner shaft and movable between a proximal position and a distal position along the inner shaft, and wherein the suture anchor is loaded onto the inner shaft by inserting the inner shaft through a cannula of the suture anchor with the outer shaft retracted to the proximal position so that the proximal end of the loaded suture anchor abuts a distal end of the outer shaft.
19. The surgical device of claim 11, wherein the driver is useable in a first mode for urging the implant into bone and in a second mode for urging the suture anchor into bone.
the spacing is determined between the proximal end of the generally conical portion and the suture anchor.
"The Autocuff™ System," Opus Medical, 2003.
501(k) Summary of Safety and Effectiveness, By: Carol A. Weideman, Ph.D., six pages, Linvatek, Mar. 21, 1997.
501(k) Summary of Safety and Effectiveness, one page, DePuy, Inc., Feb. 6, 1997.
Applications of Polyetheretherketone in Trauma, Arthroscopy, and Cranial Defect Repair, By: Scott Lovald Ph.D., and Steven M. Kurtz, Ph.D., Chapter 15, PEEK Biomaterials Handbook. DOI: 10.1016/B978-1-4377-4463.7.10015-6, Copyright 2012 Elsevier Inc, pp. 243-259.
Arthrex Bio-Corkscrew Suture Anchor Brochure (2000) (Arthrex Exhibit 2014, Smith & Nephew v. Arthrex, Case IPR2017-00275).
Arthrex Corkscrew Rotator Cuff Repair Technique Guide (1998) (Arthrex Exhibit 2017, Smith & Nephew v. Arthrex, Case IPR2017-00275).
Arthrex Is Reaching New Heights in Rotator Cuff Repair, eight pages, Copyright Arthrex, Inc., 2007.
Arthroscopic Bankart Repair Using Suture Anchors, By: Eugene M. Wolf, MD, et al., Operative Techniques in Orthopaedics, vol. 1, No. 2 (Apr.), 191; pp. 184-191.
Arthroscopic Capsulolabral Repair Using Suture Anchors, By: Eugene M. Wolf, MD; from the Department of Orthopaedic Surgery, California Pacific Medical Center, San Francisco, California, vol. 24, No. 1, Jan. 1993; pp. 59-69.
Arthroscopic Management of Partial, Full-Thickness, and Complex Rotator Cuff Tears: Indications, Techniques, and Complications, By: Eric S. Millstein, M.D., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 19, No. 10 (Dec., Suppl 1), 2003: pp. 189-199.
Arthroscopic Rotator Cuff Repair: Suture Anchor Properties, Modes of Failure and Technical Considerations, By: Richard Ma, et al., Expert Rev. Med. Devices 8(3), 377-387 (2011).
Arthroscopic Rotator Cuff Surgery, A Practical Approach to Management, By: Jeffrey S. Abrams and Robert H. Bell, ISBN: 978-0-387-39340-7.
Barber, et al.; Suture Anchor Failure Strength-An In Vivo Study; Arthroscopy: The Journal of Arthroscopic and Related Surgery, 9(6):647-652; Published by Raven Press, Ltd., 1993 Arthroscopy Association of North America (S&N Exhibit 1023; S&N v Arthrex).
Barber, et al.; Suture Anchor Failure Strength—An In Vivo Study; Arthroscopy: The Journal of Arthroscopic and Related Surgery, 9(6):647-652; Published by Raven Press, Ltd., 1993 Arthroscopy Association of North America (S&N Exhibit 1023; S&N v Arthrex).
Barber, et al.; Suture Anchor Strength Revisited; Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 12, No. 1 Feb. 1996; pp. 32-38 (S&N Exhibit 1024; S&N v Arthrex).
Barber, et al.; Suture Anchors-Update 1999; Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 15, No. 7 Oct. 1999; pp. 719-725 (S&N Exhibit 1025; S&N v Arthrex).
Biodegradable Shoulder Anchors Have Unique Modes of Failure, By: F. Alan Barber, M.D., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 23, No. 3 Mar. 2007; pp. 316-320.
Biomechanical Analysis of Pullout Strengths of Rotator Cuff and Glenoid Anchors: 2011 Update, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 27, No. 7 Jul. 2011: pp. 895-905.
Biomechanical Stability of Knotless Suture Anchors Used in Rotator Cuff Repair in Healthy and Osteopenic Bone, By: Matthias F. Pietschmann, M.D, et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 26, No. 8 Aug. 2010: pp. 1035-1044.
Brian J. Cole, et al., "Arthroscopic Shoulder Stabilization With Suture Anchors; Technique, Technology, and Pitfalls," Clinical Orthopaedics and Related Research, vol. 390, Sep. 2001, pp. 17-30.
CanMed Orthopedi, "Artroskopi Katagorisindeki Videolar" http://www.canmedortopedi.com.tr/videolar.html.
Correspondence to Mr. Mark Ritchart, President and CEO, Opus Medical, Inc., from Celia Witten, M.D., Director, Division of General, Restorative and Neurological Devices, Department of Health & Human Services, dated Sep. 17, 2001; 3 pages (S&N Exhibit 1016; S&N v Arthrex).
Current Concept of Rotator Cuff Repair, By: Stephen S. Burkhart and Wesley M. Nottage, Chapter 4, pp. 81-88.
Cyclic Loading of Anchor-Based Rotator Cuff Repairs: Confirmation of the Tension Overload Phenomenon and Comparison of Suture Anchor Fixation With Transosseous Fixation, By: Stephen S. Burkhart, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 13, No. 6 Dec. 1997; pp. 720-724.
Declaration of Dr. Geoffrey B. Higgs dated Aug. 18, 2017 (Arthrex Exhibit 2037, Smith & Nephew v. Arthrex, Case IPR2017-00275).
Disclaimer in Patent Under 37 CFR 1.321(a), U.S. Pat. No. 9,179,907, dated Feb. 28, 2017 (Arthrex Exhibit 2001, Smith & Nephew v. Arthrex, Case IPR2017-00275).
Edward Yian, et al., "Arthroscopic Repair of Slap Lesions With a Bioknotless Suture Anchor," Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 20, No. 5 May-Jun. 2004: pp. 547-551.
Evaluation of a High Density Polyethylene Fixing System for Hydroxyapatite Ceramic Implants, By: Ichiro Ono, et al., Biomaterials 21 (2000) 143-151.
Excerpt of 1999 Oxford Dictionary (Arthrex Exhibit 2009, Smith & Nephew v. Arthrex, Case IPR2017-00275).
F. Alan Barber, et al., "Internal Fixation Strength of Suture Anchors-Updated 1997," Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 13, No. 3 Jun. 1997: pp. 355-362.
F. Alan Barber, et al., "Internal Fixation Strength of Suture Anchors—Updated 1997," Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 13, No. 3 Jun. 1997: pp. 355-362.
Failure of Suture Material at Suture Anchor Eyelets, By: Dominik C. Meyer, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 18, No. 9 Nov.-Dec. 2002; pp. 1013-1019.
Fatigue Testing of Suture Anchors, By: Stefan Rupp, MD, et al., The American Journal of Sports Medicine, vol. 30, No. 2, 2002, pp. 239-247.
Fixation Strength of Rotator Cuff Repairs With Suture Anchors and the Transosseous Suture Technique, By: David V. Craft, MD, et al., 1996 by Journal of Shoulder and Elbow Surgery Board of Trustees, pp. 32-40.
Full-Thickness Rotator Cuff Tears, A Biomechanical Comparison of Suture Versus Bone Anchor Techniques, By: Stephen C. Reed, et al., The American Journal of Sports Medicine, vol. 24, No. 1, pp. 46-48.
Hecker, et al.; Pull-out strength of suture anchors for rotator cuff and Bankart lesion repairs; The American Journal of Sports Medicine, vol. 21, No. 6, 1993 American Orthopaedic Society for Sports Medicine; pp. 874-879 (S&N Exhibit 1022; S&N v. Arthrex).
Internal Fixation Strength of Suture Anchors-Update 1997, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 13, No. 3, Jun. 1997; pp. 355-362.
Internal Fixation Strength of Suture Anchors—Update 1997, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 13, No. 3, Jun. 1997; pp. 355-362.
Knotless Suture Anchor, Arthroscopic Bankard Repair Without Tying Knots, by: Raymond Thal, MD, Clinical Orthopaedics and Related Research, No. 390, pp. 42-51.
Laurence D. Higgins, et al., "Athroscopic Bankart Repair, Operative Technique and Surgical Pitfalls," Management of the Unstable Shoulder: Arthroscopic Approaches for the Next Millennium, Clinics in Sports Medicine, vol. 19, No. 1, Jan. 2000.
Maria Apreleva, et al., "Rotator Cuff Tears: the Effect of the Reconstruction Method on Three-Dimensional Repair Site Area," Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 18, No. 5 May-Jun. 2002: pp. 519-526.
Matthias Zumstein, et al., "In vitro Comparison of Standard and Knotless Metal Suture Anchors," Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 20, No. 5 May-Jun. 2004: pp. 517-520.
Mechanical Strength of Repairs of the Rotator Cuff, By: Christian Gerber, et al., From the Hopital Cantonal, Fribourg, the University of Berne and the AO Research Institute, Davos, Switzerland, The Journal of Bone and Joint Surgery, vol. 76-B, No. 3, May 1994; pp. 371-380.
Meeks & Zilberfarb Orthopedis., "Patient Education" 2007. http://www.mzortho.com/pted-videos.htm.
Michael S. George, et al., "Suture Anchors in Arthroscopic Rotator Cuff Repair," Operative Techniques in Sports Medicine 12:210-214 @ 2004 Elsevier Inc.
Mitek Products, 510(k) Summary for K974345 dated Feb. 13, 1998, 5 pages (S&N Exhibit 1015; S&N v Arthrex).
Modification of the Bankart Reconstruction With a Suture Anchor, By: John C. Richmond, M.D., et al., The American Journal of Sports Medicine, vol. 19, No. 4, 1991 American Orthopaedic Society for Sports Medicine, pp. 343-346.
Partial Repair of Irreparable Rotator Cuff Tears, By: Stephen S. Burkhart, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, Arthroscopy, vol. 10, No. 4, 1994, pp. 363-370.
Peter J. Millett, et al., "Mattress Double Anchor Footprint Repair: a Novel, Arthroscopic Rotator Cuff Repair Technique," Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 20, No. 8 Oct. 2004: pp. 875-879.
Philip Bacilla, et al., "Arthroscopic Bankart Repair in a High Demand Patient Population," Arthroscope: The Journal of Arthroscopic and Related Surgery, vol. 13, No. 1 Feb. 1997, pp. 51-60.
Practical Orthopaedic Sports Medicine and Arthroscopy, By: Donald H. Johnson, MD, FRCS, et al., 2007 by Lippincott Williams & Wilkins, a Wolters Klewer business, Chapter 20: Thermal Treatment, Sutures, Knots and Bone Anchors, pp. 303-305.
Pull-Out Strength of Suture Anchors for Rotator Cuff and Bankart Lesion Repairs, By: Aaron T. Hecker, MS, et al., The American Journal of Sports Medicine, vol. 21, No. 6, @1993 American Orthopaedic Society for Sports Medicine, pp. 874-879.
Raymond Thal, "Knotless Suture Anchor-Arthroscopic Bankart Repair Without Tying Knots," Clinical Orthopaedics and Related Research, No. 390, pp. 42-51 @2001 Lippincott Willliams & Wilkins, Inc.
Raymond Thal, "Knotless Suture Anchor—Arthroscopic Bankart Repair Without Tying Knots," Clinical Orthopaedics and Related Research, No. 390, pp. 42-51 @2001 Lippincott Willliams & Wilkins, Inc.
Repairs of the Rotator Cuff, Correlation of Functional Results with Integrity of the Cuff, By: Douglas T. Harryman II, M.D., et al., from the Shoulder and Elbow Service, Department of Orthopaedics, University of Washington, Seattle; Copyright 1991 by The Journal of Bone and Joint Surgery, Incorporated, pp. 982-989.
Robert L. Waltrip, et al., "Rotator Cuff Repair; A Biomechanical Comparison of Three Techniques," The American Journal of Sports Medicine, pp. 493-497, http://ajs.sagepub.com.
Rudy Robbe, et al., "Knotless Suture-Based Anchors," Operative Techniques in Sports Medicine, 12:221-224 @ 2004 Elsevier Inc.
Slap Lesions in Association With Complete Tears of the Long Head of the Biceps Tendon: a Report of Two Cases, By: Stephen S. Burkhart, M.D., and David L. Fox, M.D., Arthroscopy: The Journal of Arthroscopic and Related Surgery 8(1):31-35, Published by Raven Press, Ltd. @1992 Arthroscopy Association of North America.
Smith & Nephew, Inc. et al. v Arthrex, Inc., Case IPR2017-00275, U.S. Pat. No. 9,179,907, Patent Owner Arthrex, Inc.'s Response Pursuant to 37 C.F.R. §42.120 dated Aug. 18, 2017.
Suture Anchor Failure Strength-an in vivo Study, By: F. Alan Barber, M.D., et al., Arthroscopy, vol. 9, No. 6, 1993.
Suture Anchor Failure Strength—an in vivo Study, By: F. Alan Barber, M.D., et al., Arthroscopy, vol. 9, No. 6, 1993.
Suture Anchor Materials, Eyelets, and Designs: Update 2008, By: F. Alan Barber, MD, et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 24, No. 8 Aug. 2008: pp. 859-867.
Suture Anchor Strength Revisited, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 12, No. 1 Feb. 1996; pp. 32-38.
Suture Anchors-Update 1999, By: F. Alan Barber, M.D. and Morley A. Herbert PhD., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 15, No. 7 Oct. 1999; pp. 719-725.
Suture Anchors—Update 1999, By: F. Alan Barber, M.D. and Morley A. Herbert PhD., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 15, No. 7 Oct. 1999; pp. 719-725.
Sutures and Suture Anchors: Update 2003, By: F. Alan Barber, M.D, et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 19, No. 9 Nov. 2003: pp. 985-990.
Sutures and Suture Anchors-Update 2006, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 22, No. 10 Oct. 2006; pp. 1063-1069.
Sutures and Suture Anchors—Update 2006, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 22, No. 10 Oct. 2006; pp. 1063-1069.
Technique of Arthroscopic Rotator Cuff Repair Using Implantable 4-MM Revo Suture Anchors, Suture Shuttle Relays, and No. 2 Nonabsorbable Mattress Sutures, By: Stephen J. Snyder, MD, The Rotator Cuff, Part II, vol. 28, No. 2, Apr. 1997, pp. 267-275.
The Autocuff System, Opus Medical, four pages, Copyright 2003, www.opusmedical.com.
The Deadman Theory of Suture Anchors: Observations Along a South Texas Fence Line, By: Stephen S. Burkhart, M.D., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 11, No. 1 Feb. 1995; pp. 119-123.
The Evolution of Suture Andchors in Arthroscopic Rotator Cuff Repair, By: Patrick J. Denard, M.D. and Stephen S. Burkhart, M.D., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 29, No. 9 Sep. 2013; pp. 1589-1595.
The in vivo Histology of an Absorbable Suture Anchor: a Preliminary Report, By; A. Alan Barber, M.D. and Michael A. Deck, M.D., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 11, No. 1 Feb. 1995; pp. 77-81.
The Ultimate Strength of Suture Anchors, By: F. Alan Barber, M.D., et al., Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 11, No. 1 Feb. 1995; pp. 21-28.
Transcript of Jul. 21, 2017, Deposition of Dr. David McAllister (Arthrex Exhibit 2022, Smith & Nephew v. Arthrex, Case IPR2017-00275).
United States Patent and Trademark Office, Before the Patent Trial and Appeal Board, Smith & Nephew, Inc. & Arthrocare Corporation v Arthrex, Inc., Case IPR2017-00275, U.S. Pat. No. 9,179,907; Patent Owner Arthrex, Inc.'s Preliminary Response Pursuant to 37 C.F.R. 42.107.
United States Patent and Trademark Office, Before the Patent Trial and Appeal Board, Smith & Nephew, Inc. & Arthrocare Corporation v Arthrex, Inc., Case No. IPR201700275, U.S. Pat. No. 9,179,907; Declaration of Dr. David R. McAllister dated Nov. 13, 2016, 127 pages (S&N Exhibit 1019; S&N v Arthrex).
United States Patent and Trademark Office, Before the Patent Trial and Appeal Board, Smith & Nephew, Inc. & Arthrocare Corporation v Arthrex, Inc., Case No. IPR201700275, U.S. Pat. No. 9,179,907; Petition for Inter Partes Review Under 35 U.S.C. §§ 311-19 and 37 C.F.R. § 42.1 et seq., dated Nov. 15, 2016, 75 pages.
US Patent and Trademark Office, Before the Patent Trial and Appeal Board, Case No. IPR2017-00275, U.S. Pat. No. 9,179,907B2, Smith & Nephew, Inc., et al. v Arthrex, Inc., Paper 7, Entered May 10, 2017, "Decision Granting Institution of Inter Partes Review, 37 C.F.R. § 42.108".

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