CN100344263C

CN100344263C - Vertebration filler

Info

Publication number: CN100344263C
Application number: CNB031379915A
Authority: CN
Inventors: 林智一; 林冠谷
Original assignee: INTERVIDEO Inc
Current assignee: Spirit Spine Co ltd
Priority date: 2003-06-02
Filing date: 2003-06-02
Publication date: 2007-10-24
Anticipated expiration: 2023-06-02
Also published as: CN1552290A

Abstract

The present invention relates to vertebration filler and a system, particularly to a flexible non-airtight vertebration filler and a system for filling and supporting a vertebral body or for filling and supporting between two vertebral bodies. The vertebration filler / system comprises a filling member, a containing part, a filling opening and medical slurry solidified after being injected; substantially, the vertebration filler / system is reduced first and is implanted in a vertebral body or between two vertebral bodies. The present invention is characterized in that the filling member comprises one or a plurality of flexible non-airtight walls with through holes whose diameter is substantially not greater than 0.1mm; the medical slurry pushes the walls to expand; substantially, the filling member is fixedly connected in the vertebral body or between two vertebral bodies after the medical slurry is injected and solidified.

Description

A kind of vertebra filling device

Technical field

The invention relates to a kind of vertebra filling device and system, be meant a kind of flexible non-airtight vertebra filling device and system that is applied to a vertebral body or intervertebral filling support especially.

Background technology

Traditional medicine is aspect all types of treatment for lesions of vertebra, as USP5549679,5571189, United States Patent (USP)s such as 6375682B1, and other discusses osteoporosis, reduction therapy is supported in the filling that vertebra subsides etc., artificial intervertebral disc implanted treatment after intervertebral disc disorder takes out etc. all has its shortcoming, osteoporosis for example, the reduction therapy method is supported in the filling that vertebra subsides, normally bore and hammer in the vertebral body of a vertebral segments with an operation trocar (trocar), form wear again behind the tubulose channel into one or a plural number calcium phosphate pipe (be Gypsum Fibrosum, or other artificial bone fills pipe), these calcium phosphate are pushed in the vertebral body of this joint, but this method causes implant to flee easily everywhere, and the implant of overflow has the danger that is urged to nerve on the contrary.

And for example on the therapy of the implanted treatment of artificial intervertebral disk or other vertebral body pathological changes, in the past in expansion, implant support or filling etc., if not use the balloon expansion technique of U.S. Kyphon company, as USP5972015, outside the patent such as USP6066154 or USP6248110B1, implant general intervertebral supporting restorer exactly, as artificial intervertebral disk (Disk), but the balloon expansion technique of Kyphon company only resets for this vertebral body of subsiding or intervertebral being propped up the top, be packed into artificial orthopaedics implants such as calcium phosphate before afterwards also must be for another example as described, meaning promptly can produce the problem that implant is as the aforementioned fled again, and in the artificial intervertebral disk aspect, be generally metallic article and be solid shape, intervertebral Area of bearing that can't be realistic fully, support angle or other demand or the like problem.

Summary of the invention

A purpose of the present invention is to provide a kind of vertebra filling device.

Another object of the present invention with a kind of vertebra filling device that comprises a filling member and pulpous state doctor material is provided.

Another purpose of the present invention is to provide a kind of this doctor's material to be modulated into pulpous state earlier, and is filled in vertebra filling device in this filling member with injection.

A further object of the present invention is to provide a kind of this filling member earlier reduced, recharges to be pushed restorative vertebra filling device after this pulpous state is cured material.

An also purpose of the present invention with the plurality of through holes that provides on a kind of this filling member, its aperture is not more than 0.1 millimeter vertebra filling device in fact.

A still purpose of the present invention is to provide a kind of vertebra fill system, includes a filling member, an implantation tool and pulpous state doctor material.

A kind of vertebra filling device of the present invention, it comprises:

One filling member, it includes a holding part and an inlet in fact, in the first in fact reduced and implanted vertebra vertebral body of this filling member; And

One pulpous state doctor material, it is essentially injection and is filled in this filling member after fixing;

It is characterized in that: this filling member include in fact one or plural mask the flexible non-air hermetic leg of plurality of through holes is arranged, the aperture of these through holes is not more than 0.1 millimeter in fact, these legs are in fact by integrally formed or adjacent this holding part and this inlet of being connected into, this pulpous state doctor material then is filled in this holding part through this inlet injection in fact, and push these legs and expand, this filling member is essentially fixedly connected in this vertebral body after this pulpous state doctor material injects curing.

A kind of vertebra filling device of the present invention again, it comprises:

One filling member, it includes a holding part and an inlet in fact, and this filling member is the intervertebral of reduced and implanted two vertebral segments in fact earlier; And

It is characterized in that: this filling member include in fact one or plural mask the flexible non-air hermetic leg of plurality of through holes is arranged, the aperture of these through holes is not more than 0.1 millimeter in fact, these legs are in fact by integrally formed or adjacent this holding part and this inlet of being connected into, this pulpous state doctor material then is filled in this holding part through this notes population injection in fact, and push these legs and expand, this filling member is essentially fixedly connected in this intervertebral after this pulpous state doctor material injects curing.

Above-mentioned vertebra filling device, wherein respectively this flexible non-air hermetic leg can be respectively single level and/or the folded deformable leg of plural layer second phase in fact.

Above-mentioned vertebra filling device, the through-hole aperture on these legs wherein, on average (mm is preferable millimeter), is beneficial to grow into fixed from the body bone cells to be not more than 0.1 millimeter in fact.

Above-mentioned vertebra filling device, wherein the leg of this filling member can be bio-compatibility or biosynthesis (biosynthetic material) in fact, and can be made into the material of non-air-tightness and flexible container, as titanium gauze or catgut mesh grid etc., and the scrotiform that can be one of the forming, bag shape, sphere, or with these leg peripheries rectangle or the cylindricality after adjacent.

Above-mentioned vertebra filling device, but wherein this filling member in fact shuffling go into a ray video picture material, as metal wire, this metal wire makes that in fact this filling member can be in ray video picture image system, in X-ray machine, show that it is the position in this vertebra vertebral body or the intervertebral.

Above-mentioned vertebra filling device, the through-hole aperture of these legs wherein, when being essentially on average near 0.1 millimeter, these legs should adopt more than 2 layers or 2 layers stacked mutually for preferable, generally speaking, this pulpous state doctor material has high stickiness (viscosity), or the solid constituent granule is when thick (for example PMMA), get final product with stacked 2 layers, when its low stickiness or solid constituent granule are thin, should adopt more than 3 layers or 3 layers stackedly mutually, these legs are the stacked number of plies that adopts mutually, then decides according to the granular size of the stickiness of this pulpous state doctor material or solid constituent.

Above-mentioned vertebra filling device, wherein this pulpous state doctor material can be installed on an injection tube or other in fact in advance similarly can be ccontaining and produce in the electronic/non-electrical devices of squeeze force, and by as push this injection tube, be filled in this filling member and this pulpous state doctor material pushed.

Above-mentioned vertebra filling device, this flexible non-air hermetic leg wherein, come down to single level or mutually stacked braiding, soft or plasticity (flexible) leg of plural layer, the deformable leg that has plurality of through holes and form with simple layer or plural layer phase poststack, if and these legs are plural layer when mutually stacked, its plurality of through holes (mesh) is not necessarily to be a straight line to arrange (as Fig. 3 b).

Above-mentioned vertebra filling device, wherein this pulpous state doctor material can be one or a plurality of powdery, aqueous, gluey or other form in fact, after doctor's material of single kind or plural kind and solution (as: water) mix, form the semi-solid preparation material of pulpous state, and its with curable be preferable, such as bone cement (bone cement), for example polymethyl methacrylate (PMMA, poly methyl methacrylate), hydroxyapatite (HA, hydroxy apatite); Bone substituent (bone substitute), for example Gypsum Fibrosum, calcium phosphate, calcium sulfate series.

Another kind of vertebra fill system of the present invention, it comprises:

One filling member, it includes a holding part and an inlet in fact, and this filling member is in fact earlier in the reduced and implanted vertebra vertebral body or the intervertebral of two vertebral segments;

One implantation tool, it is connected with this filling member is movable in fact; And

One pulpous state doctor material, it is placed in fact earlier in this implantation tool, and injection is filled in this filling member after fixing again;

It is characterized in that: this filling member include in fact one or plural mask the flexible non-air hermetic leg of plurality of through holes is arranged, the aperture of these through holes is not more than 0.1 millimeter in fact, these legs are in fact by integrally formed or adjacent this holding part and this inlet of being connected into, this pulpous state doctor material is filled in this holding part through this inlet injection in fact, and push these legs and expand, this filling member in this pulpous state doctor material inject solidify after, be essentially secure bond in this vertebral body or this intervertebral.

Above-mentioned vertebra fill system, wherein this implantation tool in fact further includes a filling pipe and an injection tube, this filling pipe is essentially a hollow tube, one end is movable in fact to be connected to a fixed with this filling member inlet, the other end conducting that then is connected with this injection tube in fact, this injection tube in fact then includes a ccontaining tube and a push rod, and this ccontaining tube can be cured material by ccontaining this pulpous state, and enters in this filling pipe with movable this pulpous state doctor material of back and forth pushing of this push rod.

Above-mentioned vertebra fill system, wherein the leg of this filling member can be bio-compatibility or biosynthesis (biosynthetic material) in fact, and can be made into the material of non-air-tightness and flexible container, as titanium gauze or catgut mesh grid etc., and the scrotiform that can be one of the forming, bag shape, sphere, or with these leg peripheries rectangle or the cylindricality after adjacent.

Defined forward and backward among the present invention, left and right etc., generally speaking be in a human action, direction when this vertebra filling device of user hand-held enters this preparation operating area is preceding or forward, otherwise then or backward for the back towards user or the direction that withdraws from this vertebra filling device, and be a left side with the direction of user left arm, the direction of right arm be the right side.

Description of drawings

Fig. 1 is the present invention's one vertebra filling device/vertebra fill system preferred embodiment sketch map (representative graph).

Fig. 2 separates sketch map for the each several part of this vertebra filling device/vertebra fill system.

Fig. 3 a and Fig. 3 b are the single level or the folded flexible non-air hermetic leg cross-sectional schematic of plural layer second phase of a filling member.

Fig. 4 a and Fig. 4 b are a plurality of enforcement aspect sketch maps of this filling member.

When Fig. 5 a to Fig. 5 d is this vertebra fill system actual operation, is implanted to and also fills the sketch map that doctor's material forms support function in the vertebra vertebral body.

Fig. 6 is implanted between a vertebral segments for this filling member, and forms the sketch map that intervertebral disc supports after filling doctor's material.

Reference numeral:

10. vertebra filling device/vertebra fill system

20. filling member 30. doctor's materials

40. conduit 50. injection tubes

3-3. hatching

21. flexible non-air hermetic leg 22. holding parts

23. inlet 24. is folded into the tubing string shape

25. kidney shape 211. through holes

231. screw thread 251. legs

41. the conduit one end 42. conduit other ends

43. external screw teeth 44. sleeve pipes

51. ccontaining tube 52. push rods

511. the ccontaining end of ccontaining tube link 512. ccontaining tubes

70. between vertebra vertebral body 71. vertebral segments

The specific embodiment

For further specifying the present invention, cooperate graphic explanation embodiment as follows with preferred embodiment now:

Among Fig. 1, the present invention's one vertebra filling device or vertebra fill system preferred embodiment 10, wherein 20 is a filling member, 21 is the leg of this filling

member

20, and 22 is the one holding part, and 23 is the one inlet, 30 is one to be modulated into doctor's material of pulpous state, 40 is a conduit, and 50 is an injection tube, and 3-3 is a hatching of this filling member 20.

Among Fig. 2, this filling member 20 comes down to flexible non-air hermetic leg 21 integrally formed forming, this leg 21 can impact style (or otherwise, as weave shaping) form the holding part 22 (icon is for strutting the compression leg before the expansion) of a hollow, and the open opening then roll extrusion of part (or incorporating into own forces) of a side is shrunk to an inlet 23, and be provided with one or a plurality of screw thread 231 in the inner surface of this inlet 23, or this leg 21 can be a Web materials in fact, as titanium metal net or biological material mesh grid etc., or be equipped with plurality of through holes 211 on its surface, the aperture of these through holes is not more than 0.1 millimeter (Fig. 3 a in fact, shown in b two figure, as computer braiding or laser perforation), make gas or liquid can pass these through holes 211, solid constituent then can't pass through these through holes 211 in fact, and this filling member 20 is after being shaped, because of its leg 21 is that the soft of flexible deformable or plasticity material are made, so after being shaped, can be compressed again and be made its reduced volume, and after also portion is packed into material, even make this leg 21 big original form (as shown in Figures 1 and 2) of recovering to rise within it because of being subjected to pushing of this material.

This doctor's material 30 can be in fact one or a plurality of powdery, aqueous, gluey or other form originally, the composite slurry half decorating film matter of doctor's material of single kind or plural kind and solution (as: water), and this pulpous state doctor material 30 can be placed in this injection tube 50, again should doctor material 30 is that to cure material be preferable to leave standstill doctor's material curable behind the certain hour or artificial skelecton.

This conduit 40 is the tubular body of a microscler hollow, one end 41 can connect this filling member 20,42 of the other ends can be connected with this injection tube 50, after this conduit 40 connects two ends 41,42 respectively, can make this injection tube 50, conduit 40 and the 20 mutual conductings of this filling member; The end 41 that this conduit 40 is connected with this filling member 20, be provided with one or a plurality of external screw teeth 43 in fact, this external screw teeth 43 can be screwed with the screw thread 231 of these filling member 20 inlets 23, and because of this conduit 40 is a microscler body, user can be gripped on this conduit 40, this filling member 20 is advanced into specific or other optional position between a vertebral segments, the other end 42 that is connected with this injection tube 50 of this conduit 40 again, can adopt the made tubular body of any material, but when considering the convenient and/or injection of user not the recipient to restriction, so be preferable to adopt soft conduit.

This injection tube 50 can use general or the bigger commercially available syringe cylinder of caliber, it includes ccontaining tube 51 and one push rod 52, this ccontaining tube 51 is a hollow tube, one end 511 dwindles the movable conducting that is connected with the other end 42 of this conduit 40, the other end 512 is that caliber can be cured material 30 by ccontaining this pulpous state than big and hollow, 52 of this push rods just can be installed the other end 512 that enters this ccontaining tube 51 and form closed state, this push rod 52 is also movable back and forth in this ccontaining tube 51, pushes this doctor's material 30 and enters in this filling member 20 via this conduit 40.

Among these Fig. 3,3-3 is a hatching (as Fig. 1) of this filling member 20, its be for single level or plural layer second phase stacked, formed one flexible non-air hermetic leg 21 cutaway views, this flexible non-air hermetic leg 21 flexible, be to be the soft made meaning of moulding material that maybe can repeat, but not air-tightness i.e. as shown in the figure Tong Guo gas or liquid then, but solid constituent then can't pass through in fact, for example (Fig. 3 a) less than the particle diameter of this solid constituent in through hole 211 apertures of this leg 21, or because of repeating stacked its through hole 211 non-being located along the same line (Fig. 3 b) that make, slow respectively this gas of resistance, the speed that fluid molecule passes through, and stop that in fact solid constituent passes through, realize that filling is ccontaining and can push this leg again.

Fig. 4 a and Fig. 4 b implement the aspect for example of two in the aspect for this filling member; Among Fig. 4 a, these filling member 20 former being compressed are folded into a tubing string shape 24, and link also conducting on this conduit 40, and be sheathed on this conduit 40 and this filling member 20 (the do not fill full before) outside with a sleeve pipe 44, to guarantee, can not stop distort (as Fig. 4 a left side) because of preceding having when in the cone of this filling member 20 implanted vertebral segments or during intervertebral; This filling member 20 can be by integrally formed one-tenth one spheroid, oval spheroid, American football shape body, coniform body etc. again, and can after filling this doctor's material 30 of injection (Fig. 4 a right side is the kenel after having injected filling), revert to aforesaid shape by being compressed folded state.

Among Fig. 4 b, second example 25 of this filling member 20, respectively one of this leg 251 or a plurality of periphery be connected, form a kidney shape body or with reference to designed body of human body natural's intervertebral disc shape etc., make this filling member 20 if when being applied to a disc replacement, the intervertebral disc state that can more meet the human body natural, and this filling member 20 can be made material according to it, made as titanium material net, and working as its movable binding conducting one conduit 40, and when prepare implanting between a vertebral segments, because of intensity enough can be by warpage, and its outside must not add a sleeve pipe again.

Fig. 5 a to Fig. 5 d is that the use sketch map in the vertebral body is implanted in an operation of this vertebra fill system preferred embodiment 10; Among Fig. 5 a, combination has this vertebra filling device 10 of this conduit 40 and this filling member 20, under the coating of this sleeve pipe 44, serve as guiding and force application means with this conduit 40, sleeve pipe 44 earlier, filling member after this reduced volume 20 planted or be inserted into position 70 in the predetermined vertebral segments vertebral body, the additional advantage of this operation method and device institute then is the wound that can reduce to perform the operation (the material soft or hard of looking this filling member 20 determines whether this sleeve pipe 44 adds, among the figure also not shown this sleeve pipe 44).

By this conduit 40 and this injection tube 50, this sleeve pipe 44 is being withdrawed from gradually down, the pulpous state doctor material 30 that this modulated is finished is pushed in this filling

member

20,20 of this filling members are because of being subjected to pushing of this pulpous state doctor's material 30, make its leg 21 gradually diastole return to original body/volume conditions, even make this pulpous state doctor material 30 parts overflow outside the leg 21 of this filling member 20, and cause the slightly expansible state of this filling member 20 because continue to push.

Among Fig. 5 b, a period of time to be left standstill makes this pulpous state doctor material 30 present steady statue, as after condensing or solidifying (curing), rotating this conduit 40 breaks away from itself and this filling member 20, and this conduit 40 withdrawed from position 70 in this vertebral segments vertebral body, and after sewing up this surgical wound, be placed in this doctor's material 30 (as PMMA, HA etc.) in this filling member 20, can (be elder generation's implantation one right filling member 20 among the figure, and prepare to implant another left filling member 20) because of curing is supported in this vertebral body 70.

Among Fig. 5 c, sometimes because of special requirement, and must implant the filling member 25 of a kidney shape in this vertebral body 70, reset to reach this vertebra that subsides supported.

Fig. 5 d is the profile of aforementioned these Fig. 5 then, is this filling

member

20 or 25 shown in the figure in this vertebral body 70, with the situation of this vertebral segments vertebral body support.

Among Fig. 6, the filling member 25 of this kidney shape (purpose is for more meeting the shape of human body natural's intervertebral disc), also implantable between a vertebral segments 71, operation method is also for after being packed into 30 injections of this pulpous state doctor material in this filling member 25, this filling member 25 is filled satisfy, and be a synthetical vertebra intervertebral disc device in 71 of this vertebral segments.

Claims

1. vertebra filling device, it comprises:

One filling member, it includes a holding part and an inlet, in this reduced and implanted vertebra vertebral body of filling member elder generation; And

One pulpous state doctor material, it is filled in this filling member after fixing for injection;

It is characterized in that: this filling member include one or plural mask the flexible non-air hermetic leg of plurality of through holes is arranged, the aperture of these through holes is not more than 0.1 millimeter, these legs are by integrally formed or adjacent this holding part and this inlet of being connected into, this pulpous state doctor material then is filled in this holding part through this inlet injection, and push these legs and expand, this filling member in this pulpous state doctor material inject solidify after, for fixedly connected in this vertebral body.

2. vertebra filling device, it comprises:

One filling member, it includes a holding part and an inlet, and this filling member is the intervertebral of reduced and implanted two vertebral segments earlier; And

It is characterized in that: this filling member include one or plural mask the flexible non-air hermetic leg of plurality of through holes is arranged, the aperture of these through holes is not more than 0.1 millimeter, these legs are by integrally formed or adjacent this holding part and this inlet of being connected into, this pulpous state doctor material then is filled in this holding part through this inlet injection, and push these legs and expand, this filling member in this pulpous state doctor material inject solidify after, for fixedly connected in this intervertebral.

3. vertebra filling device as claimed in claim 1 or 2, wherein respectively this flexible non-air hermetic leg is single level or the folded deformable leg of plural layer second phase.

4. vertebra filling device as claimed in claim 1 or 2, the wherein scrotiform that is one of the forming of this leg, bag shape or sphere, or the adjacent back of these leg peripheries rectangle or the cylindricality that form.

5. vertebra filling device as claimed in claim 1 or 2, wherein this pulpous state doctor material is constituted the bone cement of group family and water-soluble liquid-phase mixing by polymethyl methacrylate, hydroxyapatite and is constituted.

6. vertebra filling device as claimed in claim 1 or 2, wherein this pulpous state doctor material is constituted the bone substituent of group family and water-soluble liquid-phase mixing by Gypsum Fibrosum, calcium phosphate, calcium sulfate and is constituted.

7. vertebra fill system, it comprises:

One filling member, it includes a holding part and an inlet, and this filling member is earlier in reduced and implanted vertebra vertebral body or the intervertebral of two vertebral segments;

One implantation tool, itself and this filling member is movable is connected; And

One pulpous state doctor material, it is placed in earlier in this implantation tool, and injection is filled in this filling member after fixing again;

It is characterized in that: this filling member include one or plural mask the flexible non-air hermetic leg of plurality of through holes is arranged, the aperture of these through holes is not more than 0.1 millimeter, these legs are by integrally formed or adjacent this holding part and this inlet of being connected into, this pulpous state doctor material is filled in this holding part through this inlet injection, and push these legs and expand, this filling member in this pulpous state doctor material inject solidify after, for secure bond in this vertebral body or this intervertebral.

Vertebra fill system as claimed in claim 7, wherein this implantation tool further includes a filling pipe and an injection tube, this irritates the Guan Weiyi hollow tube, one end is movable to be connected to a fixed with this filling member inlet, the other end conducting that then is connected with this injection tube, this injection tube then includes a ccontaining tube and a push rod, and ccontaining this pulpous state of this ccontaining tube is cured material, and enters in this filling pipe with movable this pulpous state doctor material of back and forth pushing of this push rod.

Vertebra fill system as claimed in claim 7, the wherein scrotiform that is one of the forming of the leg of this filling member, bag shape or sphere, or the adjacent back of these leg peripheries rectangle or the cylindricality that form.