ART /2015-E. BioPlug 3.5 and 4.2. for use in reconstructive surgery. including DVD Anterior Instability

Size: px

Start display at page:

Download "ART /2015-E. BioPlug 3.5 and 4.2. for use in reconstructive surgery. including DVD Anterior Instability"

Osborn Hunt
5 years ago
Views:

1 ART /2015-E BioPlug 3.5 and 4.2 for use in reconstructive surgery including DVD Anterior Instability

BioPlug 3.5 and 4.2 for use in reconstructive surgery BioPlug 3.5 and 4.2 are resorbable suture anchors from KARL STORZ.

BioPlug 3.5 of 2.7 mm. The material is an amorphous stereocopolymer poly-(l-co-d,l-lactide) 70:30, which has already been used with great success in the Mega Fix -B and Mega Fix -P products.

The complete instrument set for use with the BioPlug is not only reusable but has also been produced in line with the accustomed KARL STORZ high quality standards, and thus meets even the toughest

2 BioPlug 3.5 and 4.2 for use in reconstructive surgery BioPlug 3.5 and 4.2 are resorbable suture anchors from KARL STORZ. These anchors are characterized, in particular, by their material, excellent fixation strength and their pullout resistance. BioPlug 4.2 has a drill hole of 3.7 mm, BioPlug 3.5 of 2.7 mm. The material is an amorphous stereocopolymer poly-(l-co-d,l-lactide) 70:30, which has already been used with great success in the Mega Fix -B and Mega Fix -P products. This special material, and thus the BioPlug 3.5 and 4.2, degrade (bio resorb) slowly and without any resorption reactions. It remains amorphous during the entire degradation process. The complete instrument set for use with the BioPlug is not only reusable but has also been produced in line with the accustomed KARL STORZ high quality standards, and thus meets even the toughest demands. The BioPlug 3.5 comes in a unique package already preloaded with the MegaFibre USP 2 thread. The MegaFibre is a non-absorbable suture composed of a unique, ultra-highmolecular-weight polyethylene fiber. It offers greater tensile strength than polyester and polyblend sutures as well as increased lubricity and superior knot break strength. The BioPlug 4.2 is supplied in sterile packaging and without thread. KARL STORZ is a partner of DVSE (German Association of Shoulder and Elbow Surgery) 2

Anatomic reconstruction of the labrum-capsule complex in the case of a Bankart lesion Diagram of a

Tear of the middle glenohumeral ligament (MGHL) and of the anterior part of the inferior glenohumeral

Mobilization of the labrum-capsule complex with a sharp raspatory.

3 Anatomic reconstruction of the labrum-capsule complex in the case of a Bankart lesion Diagram of a Bankart lesion. Tear of the middle glenohumeral ligament (MGHL) and of the anterior part of the inferior glenohumeral ligament (IGHL). Anterior-superior, anterior-inferior portal, positioned with the SPS system. Mobilization of the labrum-capsule complex with a sharp raspatory. Insertion of glenoid guide and drilling of implant site with drill TB (dia. 3.7 mm) for BioPlug 4.2 and drill TD (dia. 2.7 mm) for BioPlug 3.5. The implant site is drilled through the inferior cannula until the mark of the respective drill. 3

Removal of the inferior thread through the anterior-superior cannula.

guiding out of the carrier thread through the anterior-inferior cannula.

4 Insertion of the BioPlug 3.5 or 4.2 suture anchor through the inferior cannula. Removal of the inferior thread through the anterior-superior cannula. Penetration of the labrum-capsule complex with the suture hook and guiding out of the carrier thread through the anterior-inferior cannula. Extracorporeal knot tying with the anchor strand that has been pulled out previously. Pulling of the thread through the labrum-capsule complex. 4

labrum capsule complex with the carrier thread (as

5 Tying of an arthroscopic slip knot (e.g. outback). Insertion of the next BioPlug anchor and penetration of the labrum capsule complex with the carrier thread (as described above) Positioning of further BioPlug 3.5 or 4.2 anchor sutures. 5

How to use the package of the preloaded BioPlug 3.

shown in the picture. The blue triangle indicates where the BioPlug is located.

6 How to use the package of the preloaded BioPlug 3.5 Open the primery sterile pouch and take the package out Hold it like it is shown in the picture. The blue triangle indicates where the BioPlug is located. The black arrow indicates the direction for the inserter Push the inserter (28179 TK) into the BioPlug 3.5 with the groove (retaining area for the thread) facing sideways. Push the inserter all the way onto the BioPlug 3.5. The anchor has to be flush on the inserter 6

Secure the MegaFibre thread by using the thread clips at the side of the handle.

7 Hold the package and just lift the inserter upwards. By tearing the paper starp on top you start to unwind the MegaFibre. Secure the MegaFibre thread by using the thread clips at the side of the handle. All BioPlug anchors are resorbable push anchors. Do not twist the Inserter in order to release him. This could damage the anchor. Pull the Inserter straight back. 7

8 28229 DS DS High-Flow Arthroscope Sheath, with snap-in coupling mechanism, diameter 6.5 mm, working length 13.5 cm, two stopcocks, rotatable, for use with HOPKINS Telescopes 0, 30, 70 and Obturators BC/BT BC Obturator, blunt, for use with Arthroscope Sheaths DS/S, color code: green-red-yellow BT Obturator, semisharp, for use with Arthroscope Sheaths DS/S, color code: green-red-yellow D Gasket Attachment, with cone, including Gasket GU for use with all arthroscope sheaths GU Gasket, for single use, unsterile, single-packaged, for use with Gasket Attachment D BX Changing Rod, length 23 cm, for use with arthroscope sheaths with inner diameter 4 mm 8

2870411 BP* BioPlug, bioresorbable suture anchor, diameter 4.2 mm, length 11 mm, sterile, for single use, for use with Inserter 28179 TI 2870310 BP* BioPlug, bioresorbable suture anchor, diameter 3.

suture anchor BioPlug 2870511 BP, with lasermarking for the depth of the drill hole, diameter 3.

9 BP* BioPlug, bioresorbable suture anchor, diameter 4.2 mm, length 11 mm, sterile, for single use, for use with Inserter TI BP* BioPlug, bioresorbable suture anchor, diameter 3.5 mm, length 10 mm, with one MegaFibre USP 2 suture, sterile, for single use, for use with Inserter TK * not for sale in the United States TB Drill, for preparation of the tunnel for suture anchor BioPlug BP, with lasermarking for the depth of the drill hole, diameter 3.7 mm, length 15 cm TD Drill, for preparation of the tunnel for suture anchor BioPlug BP, with lasermarking for the depth of the drill hole, diameter 2.7 mm, length 15 cm TI Inserter, with lateral thread guide and thread clip at the handle, working length 18 cm, for use with BioPlug BP and BP TK Inserter, with lateral thread guide and thread clip at the handle, working length 18 cm, for use with BioPlug BP H Mallet, ergonomic handle, two plane faces, length 17 cm, color code: blue 9

28179 I Crochet Hook, working length 15 cm 28179 KP Knot

Suture Cutter, for cutting sutures up to size USP 2 including:

sutures size USP 2 28179 GG Glenoid Guide, working length 12.

10 28179 I Crochet Hook, working length 15 cm KP Knot Pusher, working length 18 cm NEW KP Knot Pusher and Suture Cutter, for cutting sutures up to size USP 2 including: Insert and Blade Handle SC Suture Cutter, for cutting sutures size USP GG Glenoid Guide, working length 12.5 cm, for use with BIOPLUG BP, BP and Drills TB/TD 10

28179 GH HALF PIPE long, working length 95 mm, for use with Obturator 28179 OB 28179 GK HALF PIPE short, working length 80 mm, for use with Obturator 28179 OB 28179 OB Obturator, for use with HALF

11 28179 GH HALF PIPE long, working length 95 mm, for use with Obturator OB GK HALF PIPE short, working length 80 mm, for use with Obturator OB OB Obturator, for use with HALF PIPE GH/GK SGN SILGRASP Suture Grasper, straight jaws, sheath diameter 3 mm, straight, handle with cleaning connector, working length 14 cm AGN SILGRASP Alligator Grasping Forceps, surgical, straight jaws, sheath diameter 3 mm, straight, handle with cleaning connector, working length 12 cm AGSN SILGRASP Alligator Grasper, surgical, with ratchet, straight jaws, sheath diameter 3 mm, straight, handle with cleaning connector, working length 12 cm PGN SILGRASP Foreign Body Grasping Forceps, aggressive, straight jaws, sheath diameter 3 mm, straight, handle with cleaning connector, working length 14 cm PGSN SILGRASP Foreign Body Grasper, aggressive, with ratchet, straight jaws, sheath diameter 3 mm, straight, handle with cleaning connector, working length 14 cm 11

12 28179 BB Elevator, width 4 mm, 15 curved upwards, working length 15 cm BC Elevator, width 4 mm, 30 curved upwards, working length 15 cm CB Glenoid Rasp, width 5.5 mm, curved upwards 30, working length 15 cm CC S.L.A.P. Rasp, width 5.5 mm, curved upwards 30, working length 15 cm 12

13 28180 CB Elevator, width 4 mm, curved downwards 15, also curved downwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm CC Elevator, width 4 mm, curved downwards 30, also curved downwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm DC Glenoid Rasp, width 4.5 mm, curved upwards 30, also curved upwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm CE S.L.A.P. Rasp, width 4.5 mm, curved downwards 30, also curved downwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm CF Elevator, width 4 mm, curved downwards 15, blade turned 180, also curved downwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm CJ Elevator, width 4 mm, curved downwards 30, blade turned 180, also curved downwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm CL Rasp, for use as Glenoid or S.L.A.P. rasps, doublesided, width 4.5 mm, curved downwards 30, also curved downwards in sheath, working length 15 cm, for use with cannulas inner diameter 8.25 mm 13

Recommended Sets 28179 EB 28179 EO 28179 EC 28179 EP 28179 FB 28179 FO 28179 FC

28179 SA/SB 28179 SC/SD 28179 DF Optional: The sets include Handle 28179 DH,

Transparent plastic cannulas for single use, sterile, package of 10, are

14 Recommended Sets EB EO EC EP FB FO FC FP Positioning Needle Obturator Guide Wire Dilator DG OG SA/SB SC/SD DF Optional: The sets include Handle DH, which makes it easier to introduce Dilator DL. Transparent plastic cannulas for single use, sterile, package of 10, are available as an alternative to reusable cannulas. Threaded Cannulas SA-SD for single use are supplied unsterile. 14

15 Portal Systems for Shoulder Arthroscopy SPS Secure Portal System E Basic Set for SPS Secure Portal System including: Positioning Needle Obturator Guide Wire, package of 6 Dilator Handle, for Dilator DL Valve Housing Set of Gaskets, unsterile, package of 10 A workable instrument set requires the following supplementary sets: 1. For inner diameter 6.1 mm, working length 7 cm EB Handle, with integrated dilator EO Obturator, diameter 4 mm, for use with Handle EB SA Cannula, with thread, transparent, for single use 2. For inner diameter 6.1 mm, working length 8.5 cm EC Handle, with integrated dilator EP Obturator, diameter 4 mm, for use with Handle EC SB Cannula, with thread, transparent, for single use 3. For inner diameter 8.25 mm, working length 7 cm FB Handle, with integrated dilator FO Obturator, diameter 4 mm, for use with Handle FB SC Cannula, with thread, transparent, for single use 4. For inner diameter 8.25 mm, working length 8.5 cm FC Handle, with integrated dilator FP Obturator, diameter 4 mm, for use with Handle FC SD Cannula, with thread, transparent, for single use Optional: GS Set of Gaskets, 10x 2 sealing caps, sterile, for use with Valve Housing DG/OG GU Set of Gaskets, 10x 2 sealing caps, unsterile, for use with Valve Housing DG/OG OG Valve Housing, without LUER-Lock, for use with Cannulas and Set of Gaskets GU/GS 15

16 Suture Instruments HG Handle, for use with monofilament threads size USP 2-0 to 2, for use with Suture Attachments PA PH, NA NG and Wheel Attachment HR HR Wheel Attachment, for use with monofilament threads size USP 2-0 to 2, for use with Handle HG and Wheel R R Wheel, for use with monofilament threads size USP 2-0 to 2, for use with Wheel Attachment HR BG BG Suture Catcher, with inserter, sterile, package of 10, for use with Suture Attachments PA PH and NA NG, Wheel Attachment HR and Handle HG PA PA Suture Attachment, distal tip curved upwards, straight, 5 mm in height, working length 15 cm, for use with Handle HG PB Suture Attachment, distal tip curved upwards, straight, 7 mm in height, working length 15 cm, for use with Handle HG PC Suture Attachment, distal tip curved upwards, straight, 8 mm in height, working length 15 cm, for use with Handle HG PD Suture Attachment, hook-shaped distal tip curved upwards, straight, 8 mm in height, working length 15 cm, for use with Handle HG 16

17 28179 PE/PF PE/PF PE Suture Attachment, hook-shaped distal tip curved upwards, straight, 8.7 mm in height, working length 15 cm, for use with Handle HG and not for use with Cannulas SS/SL/BS/BL PF Suture Attachment, hook-shaped distal tip curved upwards, straight, 10 mm in height, working length 15 cm, for use with Handle HG and not for use with Cannulas SS/SL/BS/BL PG Suture Attachment, distal tip angled 30 to right, straight, 8 mm in height, working length 15 cm, for use with Handle HG PH Suture Attachment, distal tip angled 30 to left, straight, 8 mm in height, working length 15 cm, for use with Handle HG R1 Cleaning Adaptor, for use with Suture Attachments PA PH and NA NG R2 Cleaning Adaptor, for use with Handle HG 17

18 Notes 18

19 DVD is missing? Please call KARL STORZ for your free copy! It is recommended to check the suitability of the product for the intended procedure prior to use. 19

20 KARL STORZ Endoscopy-America, Inc East Grand Avenue El Segundo, CA , USA Phone: Phone toll free: (US only) Fax: Fax toll free: (US only) KARL STORZ GmbH & Co. KG Mittelstraße 8, Tuttlingen, Germany Postbox 230, Tuttlingen, Germany Phone: +49 (0) Fax: +49 (0) ART /2015/EW-E

Corrigendum for Tender for Video assisted thoracoscopic surgery for the Department of General Surgery

Date: - 15 th December 2016 Corrigendum for Tender for Video assisted thoracoscopic surgery for the Department of General Surgery NIT Issue Date : 03 rd October, 2016 NIT No. : Admn/Tender/57/2016-AIIMS.JDH