Aesculap Spine T-Space PEEK. Transforaminal Lumbar Interbody Fusion System

Transcription

1 Aesculap Spine T-Space PEEK Transforaminal Lumbar Interbody Fusion System

2 Forword Growing socio-economic pressure in conjunction with the high incidence of spinal disorders and consequent conditions calls small ventral and dorsal access channels to the spine, innovative implants to reduce tissue trauma and novel percutaneous procedures. for optimized diagnostics and therapies. This issue becomes even more urgent in the light of an ageing population and poor financial resources in the healthcare system in the coming years. Therefore minimally invasive surgical procedures, being generally cost-efficient, significantly less invasive with fewer complications, and producing better outcomes, are of particular interest. The obvious approach is using combinations of different methods. Accordingly, the innovative S 4 Spinal System, the MLD retractor system and the T-Space-PEEK cage for intercorporal fusion form an interesting combination. In this way, mono- and bisegmental fusion surgeries at the lumbar spine can be performed after a relatively short learning curve. However, minimally invasive spine surgery as a mere marketing gimmick, and at any price, cannot be the prime objective. Minimally invasive spine surgery in 2005 relies on various retractor systems to create With best regards Dr. med. habil. U. Vieweg Head, Center for Spine Stabilization 2

3 Implant Design T-Space has been designed to fit the requirements of the minimal-invasive surgical technique using the transforaminal approach. Its banana-like form ensures a maximized contact area between vertebrae and implant while being slim enough to be inserted through the foramen. T-Space has a lordosis angle of 5 and is offered in two different lengths, 26 mm and 30 mm. It ranges from 7 mm to 17 mm in 2 mm height increments. Primary stability is achieved through the toothed surfaces. In combination with a posterior fixation device such as S 4 Spinal System immediate stability of the motion segment is ensured. Length Length Height Width 3

4 T-Space Implant PEEK The material used is biocompatible PEEK-OPTIMA, which was introduced by Invibio in PEEK stands for PolyEtherEtherKetone. PEEK-OPTIMA is manufactured under rigorous conditions for purity and strict adherence to quality guidelines, and is licensed by the FDA for use as a medical implant material. The intrinsic radioscopic transparency of the material gives it permeability on x-rays and CT scans, making it possible to view bone growth adjacent to the implant. This allows quick and simple assessment of the bone structure and progress towards bone fusion. The use of PEEK-OPTIMA as an orthopedic device material enjoys increased popularity in recent years due to the material s unique combination of characteristics. It s properties include radiolucency, high mechanical strength, biocompatibility and compatibility with standard sterilization methods. Fig.1: Fig.2: Tampered end for an easy implantation Rough teeth structure to avoid migration Fig.1 Fig. 2 4

5 To verify the position of our PEEKimplants on radioscopic images, we have enclosed 3 non-radiolucent pins which serve as location markers. Of particular interest is the modulus of elasticity of PEEK-OPTIMA of 3.6 GPa, which is similar to that of cortical bone. This specific stiffness encourages load Fig. 3 sharing between implant material and natural bone, thereby stimulating bone healing activity. The material provides excellent strength and rigidity. PEEK-OPTIMA also exhibits high fatigue resistance and a low wear factor. Extensive investigations into the biocompatibility of PEEK-OPTIMA have proven that the material is suitable for the use as a long-term implant. A toothed surface offers primary stability to avoid migration in all directions. Fig. 3: Tantalum marker for an easy identification 5

6 T-Space Instruments FJ658R Straight Osteotome It can be used in combination with a mallet/hammer to cut bone. The blade width is 8 mm. FJ647R to FJ657R Distractors The distractors can be used in combination with the T-handle to distract the disc space. A rotation clockwise will gradually increase the disc height while not harming the endplate. A rotation counter clockwise will shave disc material. It should be inserted horizontally and then rotated. They are available from 7 mm to 17 mm in 2 mm increments. FJ646R T-Handle for Distractors T-handle to be used with the distractors (see below). 6

7 FJ679R to FJ680R Bone Curettes The bone curette can be used to remove the disc material as well as the cartilaginous layer on the endplates. Both straight and angled curettes are available to access the entire disc space from a unilateral approach. A Left angled bone curette FJ679R B Right angled bone curette FJ680R A B FJ681R to FJ683R Curettes Left and right angled curettes are available to access the entire space from a unilateral approach. A Box curette FJ681R B Left angled curette FJ682R B Right angled curette FJ683R A B C 7

8 T-Space Instruments FJ685R to FJ686R Bone Rasps The rasps are used to roughen the endplates and generate bleeding prior to implant insertion. Both straight and angled curettes are available to access the entire disc space from a unilateral approach. A Left angled bone rasp FJ685R B Right angled bone rasp FJ686R A B FJ666R to FJ677R Insertion Instrument for Trials and T-Space Trial Implants The trial implants are used in combination with the slap hammer to determine the proper implant height. For this purpose the trials are connected with the insertion instrument. 8

9 FJ660R T-Space Insertion Instrument The insertion instrument is used together with the insertion guide to implant T-Space. The final positioning of the implant is achieved with the help of the impactor. FJ661R T-Space Insertion Guide The insertion guide is a helping tool to guide the implant to its position. FJ662R T-Space Impactor Straight The implant pusher is used along with the insertion guide for final placement of the implant. It is also available with an angled working end. 9

10 Headline bleibt wie gewohnt Surgical Technique Positioning of the patient and incision marking (Fig. 1-2) A minimally invasive approach requires the patient to be placed on a radiolucent table which allows for AP views of the various anatomic structures. Utilize C-arm images to determine the appropriate position of the longitudinal incisions (4 5 cm in length). The intended skin incision is marked paraspinally on the right respectively on the left. Fig. 1 Incision and Exposure and blunt dissection of the paraspinal muscles (Fig. 3-6) Slightly arcuate fascial incision 1,5 cm from the midline, seen from the surgeons perspective. This guarantees a firm hold of the speculum and counter retractor, facilitating the exposure of the individual segment. After division of the thoracolumbar fascia, blunt dissection of the paraspinal muscles is performed with the finger tip. The deep anatomical situation is palpated with the finger. Orientation on the position is thus provided. In accordance with the palpatory finding, a correction of the skin incision is now still possible, as the muscle retractor should be introduced as vertically as possible and in the direction of the interlaminar space. At the same time, the distance between the skin surface and the upper edge of the arch is determined using the index finger and thumb, so that the appropriate length of the muscle retractor can be selected. Conversely, T-Space may be introduced employing a traditional open approach if so dictated by the pathology. Fig. 3 Fig. 4 Fig. 5 Fig. 6 10

11 Surgical Technique Introduction of the Spine Classics (Fig. 7-8) The appropriate muscle retractor is introduced. Note: if the fascial incision is too long, the firm hold of the retractor, thus constant exposure of the operation site, is no longer secured. As a rule, the skin incision should be slightly longer than the fascial incision to ensure firm retractor hold and to avoid skin damage due to overextension. The muscle retractor is introduced with closed blades and with the handle in the longitudinal direction of the body. It is then turned 90 clockwise with the handle towards the assistant and afterwards expanded so that the operation site becomes visible. Fig. 7 Schematic representation of the introduced muscle retractor in a horizontal section roughly at the level of the intervertebral space. The musculature is pushed away by the width of the retractor blade, namely by about 18 mm, its vessel and nerve supply practically untouched. Fig. 8 Insertion of S 4 screws (Fig. 9) Insert Aesculap S 4 Spinal System pedicle screws using the standard technique. Fig. 9 11

12 Surgical Technique Removal of Facet Joint (Fig ) In most cases, a complete unilateral facetectomy should be considered on the side targeted for implant insertion. To expedite the procedure, resect the inferior articular process of the more proximal vertebrae at the level of the pedicle. Then resect the superior articular process of the more inferior level. Fig.10 Fig. 11 Incision of the disc and removal of disc material (Fig ) Using a scalpel, cut a small window into the annulus. Remove the incised annulus using rongeurs. Posterior osteophytes are often most easily removed using Kerrison rongeurs. Fig. 12 Fig

13 Surgical Technique Distraction (Fig. 14) To achieve the desired distraction, several sizes of T-Space distractors are available and should be used step-wise to prevent injury. Distract the disc space by inserting the distractor horizontally to gauge placement depth and then rotating clockwise by 90 degrees. Fig. 14 Clearance of the intervertebral space and final endplate preparation (Fig. 15) First use the provided bone curettes to complete the removal of the disc and cartilagenous endplate. Both straight and angled curettes are provided to access the entire disc space from a unilateral approach. Additional curettes may be used to complete discectomy. Then use the rasps to completely resect the cartilagenous endplates and expose bleeding bone. Great care should be exercised to preserve the bony endplate. Fig. 15 Determination of implant size using trial implants (Fig. 16) Using the slap hammer, insert a T-Space trial into the disc space which is equivalent in height to the prior level of distraction. When properly sized, the implant trial will require impaction to reach the most anterior aspect of the intervertebral space where the implant will ultimately reside. NOTE: To verify placement of the implant trial under fluoroscopy, temporarily disconnect the slap hammer by its quick release collar. Such verification is suggested to visualize the trial fit in highly lordotic segments like L5 / S1. Fig

14 Surgical Technique Implant insertion with the help of the insertion guide (Fig. 17) Position the T-Space Insertion Guide securely into the disc space to assist in the correct and final placement of the implant. Before inserting the PEEK implant it should be filled with bone which was gained from the resection of the facet joint. Alternatively biological materials, like Tricalciumphosphate could be used. Partially insert the T-Space implant into the disc space using the implant inserter. Fig.17 Final positioning of the implant using an impactor (Fig ) Impact the implant using a standard mallet and the impactor until 90 degrees of graft rotation is achieved. Final position of the implant is then verified by x-ray. Put bone graft around the T-Space implant! Fig. 18 Fig

15 Surgical Technique Application of rod and set screw (Fig ) Then insert rods into the tulips of the pedicle screws followed by the S 4 set screws. Apply compression to the pedicle screws to minimize gaps between the T-Space implant and the disc space. Then tighten the S 4 set screws using the standard technique as described in the S 4 Surgical Technique. Finally, remove the tabs of the S 4 Pedicle Screws. Fig. 20 Fig. 21 S 4 screw positioning on contra-lateral side (Fig ) Now apply the S 4 Spinal System on the contralateral side. Fig. 23 Fig

16 Product Information 16

17 Implant Length Length Height Width Article no. Angle Height Width Length FJ 687 P 5 7 mm 11 mm 26 mm FJ 689 P 5 9 mm 11 mm 26 mm FJ 691 P 5 11 mm 11 mm 26 mm FJ 693 P 5 13 mm 11 mm 26 mm FJ 695 P 5 15 mm 11 mm 26 mm FJ 697 P 5 17 mm 11 mm 26 mm FJ 317 P 5 7 mm 11 mm 30 mm FJ 319 P 5 9 mm 11 mm 30 mm FJ 321 P 5 11 mm 11 mm 30 mm FJ 323 P 5 13 mm 11 mm 30 mm FJ 325 P 5 15 mm 11 mm 30 mm FJ 327 P 5 17 mm 11 mm 30 mm T-Space PEEK All T-Space implants are single sterile packed. 17

18 T-Space PEEK FJ 641 P Tray for Preparation Instruments Article No. Description Recommmended Optional FJ 646 R T-Handle for distractors 1 FJ 647 R Distractor 7 mm 1 FJ 649 R Distractor 9 mm 1 FJ 651 R Distractor 11 mm 1 FJ 653 R Distractor 13 mm 1 FJ 655 R Distractor 15 mm 1 FJ 657 R Distractor 17 mm 1 FJ 051 R T-Space retractor S 1 FJ 052 R T-Space retractor M 1 FJ 053 R T-Space retractor L 1 FJ 054 R T-Space retractor XL 1 FJ 658 R Straight osteotome 8 mm 1 FJ 679 R Left angled bone curette 1 FJ 680 R Right angled bone curette 1 FJ 681 R Box curette 1 FJ 682 R Left angled curette 1 FJ 683 R Right angled curette 1 18

19 Instrumentation FJ 642 P Tray for Implantation Instruments Article No. Description Recommmended Optional FJ 685 R Left angled bone rasp 1 FJ 686 R Right angled bone rasp 1 FJ 666 R Inserter for trials 1 FJ 667 R T-Space trial 7 mm 1 FJ 669 R T-Space trial 9 mm 1 FJ 671 R T-Space trial 11 mm 1 FJ 673 R T-Space trial 13 mm 1 FJ 675 R T-Space trial 15 mm 1 FJ 677 R T-Space trial 17 mm 1 FJ 660 R T-Space insertion instrument 1 FJ 661 R T-Space insertion guide 1 FJ 662 R T-Space impactor straight 1 FJ 663 R T-Space impactor angled 1 FJ 664 R T-Space PEEK packing block 1 FF 913 R Tamper 3 mm 1 FJ 641 P Tray for preparation instruments 1 FJ 642 P Tray for implantation instruments 1 T-Space PEEK 19

20 All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form. In the case of misuse we retain the rights to recall our catalogues and pricelists and to take legal actions. Aesculap AG & Co. KG Am Aesculap-Platz Tuttlingen Germany Phone Fax Brochure No. O /2/1