Background technology:
The notion of lumbar spinal fusion comes from the 1950's, through years of development, has become one of important method of diseases such as treatment lumbar vertebra wound, Lumbar Intervertebral Disc Degeneration disease and interspace of lumbar vertebrae infection at present.The tradition lumbar spinal fusion by preceding road, the way of escape or side approach implantable bone tissue and/or built-in body (as all kinds of Invasive lumbar fusion devices) between vertebral body all have one of its inevitable shortcoming be exactly widely muscle peel off with long tractive and cause soft tissue injury.Though at present Wicresoft's lumbar spinal fusion has significantly reduced the shortcoming of traditional operation, it still inevitably causes to a certain degree damage and destruction to the other soft tissue of vertebra and spine structure.Studies show that pathological changes such as paravertebral muscles ischemia, contracture, innervation disappearance cause that the postoperative power of waist weakens, chronic back pain takes place, prolong recovery time etc., have influenced surgical effect and satisfaction greatly
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It fixedly is successful that way of escape pedicle nail internal fixation system, way of escape hook bar system, ala of ilium are put the way of escape waist sacral that rod, waist sacrum intercalated disc and the little joint screw of waist sacrum be used to after the Lumbar Fusion.But it is very high that way of escape internal fixation system requires biomechanics, because want can carry axial load and load very big bend loading, this mainly is because they are placed in from the relative position far away of rotating shaft.Based on the requirement of biomechanics, way of escape Lumbar Fusion internal fixation operation may cause residual motions between sections as a treatment means independently at lumbosacral joint, causes inside-fixture loosening or lost efficacy.
Lumbar Fusion all must be destroyed the integrity of fibrous ring by preceding road, the way of escape or side approach implantable bone tissue and/or built-in body, inevitably causes shakiness, though less invasive techniques can reduce wound, can not eliminate iatrogenic destruction.Because the essential fibrous ring of destroying of these operations.Biomechanics experiment is verified, and Nuclectomy operation or Minimally Invasive Surgery will obviously destroy the stability of motion segment.The tradition internal fixation method need excise vertebral pulp by cutting fibrous ring, and this surrounding tissue that must destroy a Stabilization is extensively approved.
Concentrate on advocating and to conduct through intervertebral disc and preceding rod structure of lumbar vertebra during heavy burden, have only sub-fraction to pass through little joint and rear pillar tissue, like this, method by internal fixation between vertebral body, particularly for lumbosacral joint, front pillar is fixing because the pressure that implant is subjected near rotating shaft, has the advantage on its biomechanics.In order to reduce destruction to the rock-steady structure of motion segment, make full use of the mechanics advantage of inside-fixture, by the capable L5-S1 intervertebral of sacrum anterior approach internal fixation, promptly at S1 vertebral body pedicle screw, arrive L5 vertebral body level by the L5-S1 intervertebral disc then, axially stride across intervertebral disc, being proved to be than simple way of escape internal fixation operation has advantage on the mechanics, has avoided the destruction of fibrous ring by the intervertebral disc multiple screws.Cragg reported first in 2003 new-type percutaneous waist sacral through the rumpbone anterior approach axially merge internal fixation system---the axial restraint rod, it has reduced the damage of operation to soft tissue and spine structure by approach tissue, the vertebra to greatest extent.This system successively was applied to clinical in the U.S. and Europe in 2004,2006, obtain clinical effectiveness preferably.This technology needn't be opened abdomen and appear, and can reduce the destruction of muscle, ligament, the most important thing is not destroy the fibrous ring and the stability of L5-S1 level.
The sacrum anterior approach not only for the single sections of L5-S1 fixedly fusion can accomplish, and can be used for 2 sections and merge, comprise L4-5, L5-S1.On biomechanics and minimizing complication, axial restraint merges and can have superiority than traditional method.Yet insufficient is that the clinical research data show, the axial restraint rod is than surrounding tissue---the vertebral body spongy bone has stronger rigidity, and the greatest differences of elastic modelling quantity certainly leads to stress shielding, causes the absorption of adjacent bone.This stress-shielding effect has caused the absorption of bone, follows built-in body and sink, and intervertebral height is lost, thereby faces essential this worst clinical effectiveness of revision procedure.Though the axial restraint rod is used to can reach the highest stability with the application of way of escape fixing joint recently, operation costs an arm and a leg, and operation is comparatively complicated, has prolonged operating time to a certain extent and has increased operation wound.
Summary of the invention:
In order to solve the stress-shielding effect of axial restraint rod, seek with a kind of can utilize sacrum anterior approach axial restraint realize intervertebral fusion and do not destroy fibrous ring and stability advantage, can overcome the stress-shielding effect that the built-in body of high rigidity produces again between vertebral body, can share load with the bone of new formation, stimulate the intensity of area of new bone, provide in early days the basis of mechanical fixation can finish biology fixed novel implant and using method be purpose of the present invention---a kind of interbody bone graft axial restraint system and using method promptly are provided, wound at spinal column, the degenerated illness, in the surgical intervention of degeneration illness and other unstable spine illness, the lumbar spinal fusion eligible patients is arranged by this internal fixation system of utilization, row sacrum anterior approach bone grafting axial restraint is realized intervertebral fusion and is not destroyed the lesion segment of fibrous ring, it is finished smoothly on the fixed operation technique of the interbody bone graft basis, simplify operation technique, reduce operation wound, thereby minimizing post-operative complication, shorten the hospital stays, reduce hospitalization cost, improve surgical effect and satisfaction.
Technical scheme of the present invention is interbody bone graft axial restraint system and using method, mainly comprises: 1 interbody bone graft axial restraint device and supporting banking pin thereof.2 is the matching used installing apparatus of interbody bone graft axial restraint fixed system.The using method of 3 interbody bone graft axial restraint systems
1 interbody bone graft holder and supporting banking pin thereof:
1) interbody bone graft axial restraint device: construction features: 1. hollow cylindrical, have from external threading, can being screwed in the vertebral body at cross like spanner.2. guide pinhole is arranged is the position that guide pin passes to anteriomedial.3. the rear portion has cross recessed, is complementary with cross like spanner.4. there is internal thread hole in rear portion central authorities, are complementary with the fixedly inner core of cross like spanner and the external screw thread of spacing ailhead.5. have around perforation circle and (or) slotted eye, can clog in broken bone goes into, also be area of new bone grow into passage.
2) banking pin: construction features: the nail body be bright finish and (or) band tapping screw thread, ailhead has the female thread of external screw thread and interbody bone graft axial restraint device rear portion central authorities to be complementary, the inner hexagon spanner of interior hexagonal groove and spacing ailhead is complementary; After the implantation interbody bone graft axial restraint device, plant bone mass and the series connection of upper vertebral body are fixed together the effect that restricted plant bone mass is subjected to displacement between last hypocentrum.Have interbody bone graft axial restraint device simultaneously and seal effect.
2 is the installing apparatus that the system support of interbody bone graft axial restraint is used.
1) perforate dilator is made up of inner core and sleeve, and the inner core far-end is an epiconus, and near-end has the attacking head consistent with sleeve outer diameter; Sleeve diameter and inner core external diameter are complementary, the consistent size of external diameter with the attacking head external diameter of inner core, distal taper is consistent with the epiconus of inner core far-end, be used to cut perforate behind skin and the subcutaneous tissue, before the rumpbone soft tissue of passivity split extension presacral space, through S1/S2 intercalated disc.
2) expanded casing: internal diameter and perforate dilator external diameter are complementary, and distal taper is consistent with the epiconus of inner core far-end, are used for the soft tissue of passivity split extension presacral space before the rumpbone, avoid damaging rectum, are the working column transition.
3) access sheath: the service aisle that is cage shape interbody bone graft holder operation technique, internal diameter and expanded casing external diameter are complementary, far-end is the inclined-plane, tapering is consistent with the epiconus of inner core far-end, be used for the soft tissue of passivity split extension presacral space before the rumpbone, the sharp side that reaches S1/S2 intercalated disc back bevel can be knocked in the S1/S2 intercalated disc, obtains the relative fixed position, near-end one side has the column handle, for later various operations keep relative fixed.
4) bone awl: comprise sleeve handle and inner core, the sleeve handle is that a cylindrical grooves is arranged in the middle of the T font handle portion, respectively there is a gap slot both sides at the bottom of the groove, cylindrical grooves and gap slot and cylindric interior core print and fixed block thereof are complementary, bone tapered sleeve tube internal diameter is consistent with the external diameter of inner core, and external diameter is consistent with the external diameter of perforate dilator inner core; Bone vertebra inner core body is the bright finish slender cylinder, far-end is the four sides vertebral body, head is that exasperate short cylinder base portion has two fixed blocks, fixed block size is consistent with the gap slot of sleeve handle, after inserting bone vertebra inner core in the bone tapered sleeve tube fully, the rotation head can be inserted two fixed blocks in the gap slot of sleeve handle, and it is as a whole that both are united two into one into.
5) guide pin
6) working column
7) get the bone trepan: form by trepan head and hollow connecting rod, the rectangle through hole is arranged in the middle of the trepan head far-end indentation, body, the right high left side of long rectangular edges low (nuance) in hole, not transfer of bone piece during with assurance dextrorotation, bone is conveniently got in the not transfer of bone piece when left-handed.Hollow connecting rod near-end is the rhizoma sparganic column for one section, as T type handle and (or) interface of electric drill.
8) vertebral pulp reamer has dentation reamer head, connecting rod and T type handgrip to constitute.
9) bone piece driver: jug and body are formed, and body is a hollow circular cylinder, and the internal diameter of external diameter and supporting working column is complementary, and internal diameter and guide pin external diameter are complementary, and far-end is near plant bone mass, and near-end has scale and links to each other with handle; Handle is thicker hollow circular cylinder, and external diameter is greater than access sheath, and internal diameter and guide pin external diameter are complementary, and distal shaft section will links to each other, and near-end is a strike portion, is plant bone mass is squeezed into interpyramidal stress point (Fig. 5).
10) bone piece extractor: be the spongy bone screw tap of the M3.5 of T type handle.During use the screw tap head is gone into along the bone piece central duct vertebra in the trepan head that withdraws from guide pin, slightly firmly can take out the bone piece in the trepan head after entering fully.
11) cross like spanner: by cross like spanner and fixedly inner core form.Cross like spanner is the T type, and body is a hollow circular cylinder, and the internal diameter of external diameter and supporting working column is complementary, internal diameter and guide pin external diameter are complementary, far-end is an external screw thread, be complementary with the cross of cage shape interbody bone graft retainer back central authorities is recessed, near-end with walk crosswise handle and join; Fixedly the inner core body is a hollow circular cylinder, the internal diameter of external diameter and cross like spanner is complementary, internal diameter and fixedly the inner core external diameter be complementary, far-end is an external screw thread, be complementary with the internal thread hole of cage shape interbody bone graft retainer back central authorities, near-end exasperate brachymedial hollow round column body, convenient rotation is the interbody bone graft holder fixedly.
12) inner hexagon spanner: be the T type, head hexahedron size is complementary with the interior hexagonal groove of spacing ailhead, is used to screw in banking pin.
The using method of bone converged fixed system between 3 vertebral bodys:
1) set up service aisle: the other incision apart from anus 5~10cm place is about 2~3cm skin and subcutaneous tissue on the coccyx right side, pass fascia at the bottom of the basin with the perforate dilator, part withdraws from inner core tailing edge presacral space and under the guiding of X line perforate dilator head is sent to zone, center, S1/S2 gap, and the epiconus of inner core far-end is knocked in the S1/S2 gap.Expanded casing screwed in gently along perforate dilator outer wall reach center zone, S1/S2 gap.Access sheath screwed in gently along the expanded casing outer wall reach center zone, S1/S2 gap, the sharp side on the inclined-plane of access sheath can be knocked in the S2 bone, obtain the relative fixed position.Take out the inner core of perforate dilator, insert the bone awl, under the guiding of X line, bone bored month 1cm in the S1 vertebral body.Take out bone awl inner core, insert guide pin, under the guiding of X line, guide pin is pierced the central authorities of the soleplate of upper vertebral body.Take out perforate dilator sleeve and expanded casing respectively, insert the working column of corresponding specification along the access sheath inwall.
2) implement axially to get bone, interbody space bone grafting and fixing
Insert the trepan of corresponding specification in working column along guide pin, dextrorotation enters the soleplate of upper vertebral body, withdraws from trepan after the counter-rotating and takes guide pin, saw bone piece and part vertebral pulp well simultaneously in the lump out of.The passage that stays is inserted the working column of corresponding specification.With the vertebral pulp reamer and (or) vertebral pulp pincers by working column L5/S and (or) clear up nucleus pulposus in the L4/L5 gap.With guide pin, the packaged piece to the marrow of the external bone that trims driver, through working column with the bone piece that trims send to L5/S and (or) central authorities of the soleplate of the upper vertebral body in L4/L5 gap, withdraw from bone piece driver and unnecessary working column after the compacting, stay guide pin.The cage shape interbody bone graft holder of suitable size is installed on the cross like spanner, and the interbody bone graft holder length is with reference to the scale of bone piece driver near-end, and diameter gets final product than the big 2cm of trepan external diameter.Bone piece below after sending to the interbody bone graft holder in fact by working column along guide pin with cross like spanner screws in clockwise until forming compaction state at the bone piece, reaches the bone fixation piece in interpyramidal purpose.Unclamp the fixedly inner core of cross like spanner successively, take out cross like spanner and fixing inner core thereof, take out guide pin, can send into banking pin through working column with inner hexagon spanner as the case of lumbar instability reaches interbody bone graft retainer back central authorities internal thread hole is arranged, screw in clockwise and can guarantee that until screwing the bone fixation piece displacement all around can not take place between vertebral body, also have the effect of sealing.Take out inner hexagon spanner, working column and access sheath successively, closed wound.
The specific embodiment:
Embodiment 1:
As shown in Figure 1: interbody bone graft axial restraint system comprises that interbody bone graft axial restraint device (1.1), banking pin (1.2) and supporting special equipment get bone trepan and bone piece driver.Method is: the bone trepan is ready-made to be got the plant bone mass (1.4) that bone bone grafting passage (1.3) will be delivered to interbody space by bone piece driver and is fixed on the next interbody space (1.5) firmly interbody bone graft axial restraint device (1.1) with getting through S1/S2 by the sacrum anterior approach; Banking pin (1.2) enters from the duct of interbody bone graft axial restraint device (1.1) rear portion central authorities, pass plant bone mass and reach in the upper vertebral body (1.6), interbody bone graft axial restraint device (1.1), plant bone mass (1.4) and upper vertebral body (1.6) series connection are fixed together.
Embodiment 2:
As shown in Figure 2: interbody bone graft axial restraint device is a hollow cylindrical, has from external threading (2.1).It is characterized in that it is the position that guide pin also passes that anteriomedial has guide pinhole (2.2), be cascaded by the plant bone mass of guide pin with the top, guarantee when screwing before the quadrate bone piece be not shifted.There is cross recessed (2.3) at the rear portion, is complementary with cross like spanner, and there is internal thread hole (2.4) in rear portion central authorities, is complementary with the fixedly inner core of cross like spanner and the external screw thread of spacing ailhead.Have all around perforation circle and (or) slotted eye (2.5), can clog in broken bone goes into, also be area of new bone grow into passage.
Embodiment 3:
As shown in Figure 3: banking pin, the nail body be bright finish and (or) band tapping screw thread (3.1), ailhead (3.2) has the external screw thread (3.3) and the female thread of interbody bone graft axial restraint device rear portion central authorities to be complementary, and ailhead (3.2) central authorities have the interior hexagonal groove (3.4) and the inner hexagon spanner of spacing ailhead to be complementary; Interbody bone graft axial restraint device plant bone mass and the series connection of upper vertebral body can be fixed together.The effect that restricted plant bone mass is subjected to displacement between last hypocentrum.Have simultaneously interbody bone graft axial restraint device is sealed effect.
Embodiment 4:
As shown in Figure 4: get the bone trepan, be made up of trepan head (4.1) and hollow connecting rod (4.2), rectangular opening (4,4) is arranged in the middle of trepan head (4.1) the far-end indentation (4.3), body, there is 2-3 heel teeth (4.5) on the long rectangle the right in hole.Not transfer of bone piece in the time of can guaranteeing dextrorotation, bone is conveniently got in the not transfer of bone piece when left-handed.Getting the bone trepan and be not only the bone instrument of getting, also is the instrument of setting up interbody bone graft, carrying out the axial restraint passage.
Embodiment 5:
As shown in Figure 5: bone piece driver (Fig. 5) is made up of body (5.1) and handle (5.2), body is a hollow circular cylinder, and the internal diameter of external diameter and supporting working column is complementary, and internal diameter and guide pin external diameter are complementary, far-end is near plant bone mass, and near-end has scale and links to each other with handle; Handle is thicker hollow circular cylinder, and external diameter is greater than access sheath, and internal diameter and guide pin external diameter are complementary, and distal shaft section will links to each other, and near-end is a strike portion, is the stress point of plant bone mass being squeezed into interbody space.
Embodiment 6:
As shown in Figure 6: through the sacrum anterior approach, with guide pin (6.1.1) and working column (6.1.2) after operation path is set up in leading edge center in S1/S2 gap, with getting the bone trepan along guide pin dextrorotation, go in ring and cut S1 leading edge center part vertebral body,, withdraw from trepan after the counter-rotating and take guide pin, saw bone piece and part vertebral pulp well simultaneously in the lump out of up to the soleplate that enters upper vertebral body (6.1.3) through claims 1 described interbody space (1.5).The cavity that stays becomes claims 1 (4) described interbody bone graft, carries out the axial restraint passage.The bone piece that external rest and reorganization are good by guide pin with described bone piece driver (5) string of claims 5 together, along working column and trepan get behind the bone in cavity that the S1 vertebral body stays claims 1 described plant bone mass (1.4) that trims sent to claims 1 described L5/S and (or) central authorities of the soleplate of the upper vertebral body (1.6) of L4/L5 gap (1.5), withdraw from bone piece driver and unnecessary working column after the compacting, stay guide pin (6.2).Claims 1 described interbody bone graft axial restraint device (1.1) is installed on the cross like spanner (6.3.1), along guide pin claims 1 described interbody bone graft holder (1.1) is sent to bone piece below after the compacting by working column with cross like spanner, screw in clockwise until with bone piece compacting (6.3).With inner hexagon spanner claims 1 described banking pin (1.2) is installed, through working column with claims 1 described banking pin (1.2) send to claims 1 described interbody bone graft holder (1.1) rear portion central authorities as internal thread hole (2.4) as described in claims 2, screw-in reaches in claims 1 described upper vertebral body (1.6) until passing claims 1 described plant bone mass (1.4) through claims 2 described guide pinholes (2.2) clockwise, with claims 1 described interbody bone graft axial restraint device (1.1), plant bone mass (1.4) and upper vertebral body (1.6) series connection are fixed together.Can guarantee that the bone fixation piece displacement all around can not take place between vertebral body, the effect (6.4) of sealing is also arranged.