The degenerative stenosis of the lumbar spinal canal is a pathologic disease which leads to the progressive closure
of the vertebral foramen and / or the conjugate foramen.
Lobster Project® is an implantable device for percutaneous interspinous distraction.
Lobster Project® is an implantable device for percutaneous interspinous distraction. It is implanted through a percutaneous surgical technique with a specific and dedicated instruments set; it’s indicated for patients with less severe stenosis mainly tied to soft tissues, soft stenosis, or in patients who are not candidates for a surgical interventions under general anesthesia.
The distance existing between the conservative techniques and the "open" surgery finalized to spinal fusion has been filled with Lobster®, the first dynamic percutaneous interspinous spacer, optionally removable after being implanted. The device is indicated in the treatment of degenerative lumbar canal stenosis, which causes dull ache or acute back pain, which may radiate to the lower limbs with weakness in the legs and loss of balance during walking (claudication neurological).
Through mini-invasive percutaneous technique, the Lobster® device allows the indirect decompression of the spinal canal; it determines the reduction of the freedom of movement in extension of the treated vertebral bodies while keeping the normal rotation capacity and spinal flexion axis. This allows the distension of the posterior portion of the column reducing the eventual disc protrusion and the thickness of the yellow ligaments. These effects increase the size of the spinal canal with reduction or resolution of the associated pain.
How it works
The Lobster® device is intended to stop the segmental extension and to distract the interspinous space between the lumbar spine vertebrae (L1-L5), maintaining the foraminal height, opening up the area of the spinal canal, reducing stress on the facet joints and relieving pressure on the posterior annulus of the intervertebral disc.
Lobster® is implanted through a minimally invasive surgical technique with a specific and dedicated instruments set.
The device consists of a fusiform body with a central saddle, and 4 "wings" that open and close, located at the end of the central body.
The central saddle is designed to be inserted between the two vertebral spinous processes, object of distraction, while long “wings", opened after the implant placement, prevent ventral and lateral migration of the device.
• Short surgical procedure under local anesthesia.
• Percutaneous Technique; small skin incision, less blood loss and reduced muscle trauma. Mini-invasive.
• Preserves anatomical structures.
• Limit Extension movements
• reduce stress on the facet joints
• maintain the foraminal height
• 6 sizes to accommodate different patient anatomies
• Instrument set allows to close the wings and possibly remove the device
• 3 different configurations of the device
*only on request
Lobster Project® is available in 2 different versions:
• Titanium (code LBT)
• Central body in titanium / PEEK coated (code LBS)
• Central body in titanium / Medical Silicone coated (Code LBN) *not yet available
All implants are delivered STERILE
• Central, lateral and foraminal lumbar spinal stenosis with leg, buttock or groin pain, which can be relieved during flexion.
• Soft disc protrusions with discogenic low back pain.
• Facet syndrome due to facet osteoarthritis.
• Degenerative spondylolisthesis up to grade I with hyperlordotic curve. • Degenerative Disc Disease (DDD) with retrolisthesis.
• Severe Osteoporosis.
• Conus/Cauda syndrome.
• Severe structural spinal stenosis lacking a dynamic component.
• Degenerative spondylolisthesis at index level of grade > I according to Meyerding.
• Scoliotic deformity at index level.
• DDD with fixed retrolisthesis.
• Sequestrated disc herniation.
• Spinous process and/or lamina dysplasia.
• Morbid obesity.
• Interspinous pain arising from Baastrup syndrome (“kissing spines”).
Lobster® instrument set is composed by all the necessary tools to insert the device percutaneously, with or without the use of dilators tubes.
The device has the unique feature of being eventually removed, even when the Lobster® is placed with opened wings, using the same holder tool.
|LOB-0102||Opening tube for implant holder|
|LOB-0103||Fixing shaft for implant holder|
|LOB-0104||Quick connect cannulated handle|
|LOB-0108||Batting Support for dilatation tube 03|
|LOB-0201||Dilatation Tube 01 with quick connect for handle|
|LOB-0202||Dilatation Tube 02|
|LOB-0203||Dilatation Tube 03 with 2 Tines|
|LOB-0204||Dilatation Tube 04|
|LOB-0205||Dilatation Tube 05|
|LOB-0308||Implant Probe 8 mm|
|LOB-0310||Implant Probe 10 mm|
|LOB-0312||Implant Probe 12 mm|
|LOB-0314||Implant Probe 14 mm|
|LOB-0316||Implant Probe 16 mm|
|Place the patient in a comfortable prone position.
It is necessary to obtain a neutral position of the physiological lumbar lordosis, so that the interspinous space is distracted in a natural way. Proceed with general or local anesthesia.
Identify and confirm the entry level with spinal needle
Percutaneous lateral surgical approach. Stabilizing anatomical structures are preserved:
Define landmarks in projection to the skin level, marking under fluoroscopy the spinous process of the inferior and superior level being treated. The entry point for the instruments is in the middle between these two points, on the posterior contour of the facet joint.
Make a longitudinal or transverse incision of approximately 2 cm at the previously defined entry level.
Guide wire introduction
Introduce guide wire (LOB-0105) through the incision.
Under lateral fluoroscopy, carefully advance the guide wire between the spinous processes, keeping it parallel to the coronal plane and centered between the two spinous processes until it reaches the interspinous ligament, which gives a slightly increased resistance.
Interspinous ligament perforation
Take the dilatation tube 01 (LOB-0201) and fit it on the quick connect cannulated handle (LOB-0104).
Dilatation tubes insertion
Do the same procedure with the dilatation tubes 04 (LOB-0204) to implant Lobster size 14.
To implant the size 16, also use the dilatation tube 05 (LOB-0205).
Implant size selection
|Choose the implant size with the probes starting from the smallest size (LOB-0308 – yellow handle) and insert it into the dilatation tube 03, gently pushing the trial implant through the ligament between the two spinous processes.|
Open the packaging
After establishing the correct size, open the sterile implant package chosen, selecting it among the 2 available versions :
- Lobster - Titanium / LBT
- Lobster - Titanium-Peek / LBS
Holder and Implant assembly
4. Before implanting the device, do a preliminary check by opening and closing it.
||Retract the dilatation tube 3 and begin the process of gradual and simultaneous opening of the fins, to fix the device.
Rotate counter-clockwise the opening tube (LOB-0102) to open the device, until the device opens completely.
The fins lock automatically when they reach their maximum opening, not going over. Do not force them further.
Implant release and end of the intervention
Turn counterclockwise the fixing shaft (LOB-0103) to remove the thread on the rod from the device; retract of 3 cm.
Retract the tube opening for implant holder (LOB-0102) of 3 cm taking care not to rotate it, and then retract the implant holder (LOB-0101).
Extract the dilation tube and suture the entrance hole.
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