CN107920846A

CN107920846A - Expansible Invasive lumbar fusion device equipment, system and its manufacture method with hinges

Info

Publication number: CN107920846A
Application number: CN201580082740.7A
Authority: CN
Inventors: 摩根·帕卡德·洛里奥
Original assignee: 摩根·帕卡德·洛里奥
Current assignee: EIT Emerging Implant Technologies GmbH
Priority date: 2015-08-30
Filing date: 2015-08-30
Publication date: 2018-04-17
Also published as: WO2017039596A1; KR20180072675A; AU2015408035A1; EP3344170A4; BR112018003590A2; EP3344170A1; JP2018528844A; AU2015408035B2

Abstract

A kind of expansible Invasive lumbar fusion device with hinges manufactured using 3D printing.The Invasive lumbar fusion device is configured to never expanded configuration and expands to expanded configuration.The Invasive lumbar fusion device can include development system, such as variable-volume pouch or expansion cable, so as to the Invasive lumbar fusion device applying power, so that the Invasive lumbar fusion device be unfolded.

Description

Expansible Invasive lumbar fusion device equipment, system and its manufacture method with hinges

Cross reference to related applications

This application involves：Entitled " the INTERVERTEBRAL DEVICE AND that September in 2011 is submitted on the 29th The U.S. Patent Application No. 13/248,747 of METHODS OF USE [intervertebral device and application method] ", it requires the U.S. interim The priority of application number 61/389,986；On 2 20th, 2015 entitled " the INTERVERTEBRAL CAGE submitted APPARATUS AND SYSTEM AND METHODS OF USING THE SAME [Invasive lumbar fusion device equipment and system and its make With method] " U.S. Patent Application No. 14/422,750, it is the PCT Application No. PCT/ that August in 2013 is submitted on the 23rd Thenational phase applications of the US2013/056500 under 35U.S.C. § 371, PCT Application No. PCT/US2013/056500 requirements The U.S. Provisional Application No. 61/693,738 and the U.S. Provisional Application submitted on March 12nd, 2013 that August in 2012 is submitted on the 27th Number 61/778,271 priority；And on 2 26th, 2014 entitled " the VERTICALLY EXPANDABLE submitted INTERVERTEBRAL CAGE, DEPLOYMENT DEVICES, AND METHODS OF USING THE SAME [can expand vertically Invasive lumbar fusion device, expanding unit and its application method of exhibition] " PCT Application No. PCT/US2014/018772, it requires 2013 The priority for the U.S. Provisional Application No. 61/778,220 submitted on March 12, the full contents of all applications explicitly by Quote and be incorporated herein.

Technical field

Present invention relates in general to a kind of expansible Invasive lumbar fusion device or implant used in spinal fusion surgery, more Particularly relate to the equipment, system and method for manufacturing the expansible Invasive lumbar fusion device using 3D printing method.

Background technology

Vertebra is the single irregular bone for forming backbone.The mankind generally have three tridecyne vertebras, including merge to be formed Five pieces of vertebras (other vertebras are by disc separation) of rumpbone and four pieces of pygostyles for forming coccyx.Upper three regions include surplus Remaining 24 pieces, and the region according to occupied by them is grouped into title：Cervical vertebra (7 pieces of vertebras), thoracic vertebrae (12 pieces of vertebras) and Under lumbar vertebrae (5 pieces of vertebras).This quantity increases extra vertebra in a region sometimes, or this quantity in a region may be used It can reduce, defect is usually made up by the extra vertebra in another region.However, the quantity of neck bone seldom increases or subtracts It is small.

Typical vertebra is made of two essential parts：Before (anterior/front) section, it is centrum；And rear portion-vertebra (nerve) bends, it surrounds taper hole.Vertebral arch is formed by a pair of of pedicle of vertebral arch and a pair of of lamina, and supports seven projections：Four passes Section is prominent, two transverse process and a spinous process, the latter are also referred to as neural spine.

When vertebra with joint is connected each other when, these bodies form strong column for supporting head part and trunk, and these bore Hole forms pipeline for protection spinal muscle marrow (spinal cord), and between each pair vertebra is then two apertures, i.e. intervertebral foramen, on every side One, it is used for transmission spinal nerve and blood vessel.

Device assembly is merged stablize vertebra using conventional spinal in spinal fusion surgery.Spinal fusion typically with Device assembly is merged by adjacent vertebrae is spaced apart and is merged purposes.Spinal fusion techniques, which include removal, makes vertebra separated Disk material and bone is struck in disk area.These fusion device assemblies are generally hollow and include opening in its sidepiece To provide path for bone uptake.These fusion devices are usually formed by titanium and have different shapes and sizes.

Current intervertebral or interbody fusion cage is designed using 3 main principles；The anatomy limitation of operation method, Bone collection volume is optimized to promote bone grafting to merge and optimize contact of the device with endplate with resistance It is heavy.Present fusion device is generally static, because they can not change shape or volume, thus they are by anatomical structure and skill Art limits, and therefore they do not provide optimal bone collection volume or surface contact.

Many conventional spinals merge the parallel stretching that device assembly uses opposing vertebra before implant is placed.However, not It is that all vertebras are all parallel opposite.Normal and healthy backbone, which has, is referred to as lordotic natural torsion portion.Because this is curved Pars convoluta, opposing vertebra are positioned such that their soleplate is in not parallel alignment, this depends on the position in backbone.

A kind of Invasive lumbar fusion device or implant are needed, it can be extended to change shape and/or volume, there is provided optimal bone moves Implant product or surface contact, so as to which desirable lordosis is maintained or realized between opposing vertebra.The present invention attempts to solve These problems and other problems.

The content of the invention

The some embodiments of the application are related to expansible Invasive lumbar fusion device and production and preparation method thereof some embodiments and relate to And may be configured to be positioned at the Invasive lumbar fusion device being positioned between two pieces of vertebras and definitely between two endplates, The including but not limited to specific Invasive lumbar fusion device of patient.

The side of expansible Invasive lumbar fusion device is manufactured by increasing material manufacturing (also referred to as 3D printing) there is disclosed herein one kind Method.The expansible Invasive lumbar fusion device can be molded into single single piece and successively construct from bottom to up, so that this A little components are entirely connected by hinges.

In one aspect of the invention, it is a kind of to be used for manufacture for can print using 3D between being placed on adjacent vertebrae The method of the expansible Invasive lumbar fusion device with hinges of material, this method include：It is expansible that this is provided to 3D printer The 3D data of Invasive lumbar fusion device, the expansible Invasive lumbar fusion device include detour (circuitous) main body, which has The multiple side segments being rotatably attached by Integral type movable hinge, these Integral type movable hinges are configured to make the detour Main body never expanded configuration is converted to flexure or deformation during expanded configuration；And it can print material using one or more 3D Material prints this multiple side segment and these Integral type movable hinges of the detour main body.

In certain embodiments, one or more 3D materials are selected from the group being made of the following：Thermoplastic Property plastics, photopolymer, metal dust, eutectic metal, titanium alloy, and combinations thereof.In certain embodiments, one kind or more Kind 3D materials are selected from the group being made of the following：Examples of natural biocompatible materials, synthesising biological compatibility material, Biocompatible metal material, adaptive material, 4D printed materials, and combinations thereof.In certain embodiments, the one or more 3D materials are selected from the group being made of the following：Polyether-ketone (PEK)；Polyetherimide (PEI), such as Ultem；It is super High molecular weight polyethylene (UHMPE)；Polyphenylene；Polyether-ether-ketone (PEEK), including memory PEEK materials, such as PEEK Altera；And combinations thereof.In certain embodiments, the 3D of the relative flexibility, which can print material, includes nonmetallic materials, and should The 3D of relative stiffness, which can print material, includes metal material.

In certain embodiments, which includes external coating, which is from the group being made of the following Middle selection：Plasma spray, hydroxyapatite coating layer, biological agent, antibiotic, medicine or gene therapy, nanometer technology Platform, and combinations thereof.

In certain embodiments, the 3D that these Integral type movable hinges include relative flexibility can print material, and these sides The 3D that segment includes relative stiffness can print material.

In certain embodiments, which is the predefined data of standard fusion device size.In certain embodiments, should 3D data are 3D imaging datas, and this method further comprises：The adjacent vertebrae of patient is imaged before operation to generate 3D imaging datas.

In certain embodiments, these hinges include being configured to permit the localization of the detour main body to bend or become The narrowed portion of the detour main body of shape and/or to the notch in the detour main body.

In certain embodiments, which arranges proximally and distally on the contrary including laterally axis, and The near-end is distally in largest interval with this under the non-expanded configuration, and the near-end distally exists with this under the expanded configuration Together closer to the expansible Invasive lumbar fusion device is configured between adjacent vertebrae flatly expand to this from the non-expanded configuration Expanded configuration.

In certain embodiments, which includes top panel and bottom panel, the top panel and the bottom faces Each free Integral type movable hinge of plate is rotatably attached on one or more side segments, the expansible Invasive lumbar fusion device by with It is set between adjacent vertebrae from the non-expanded configuration and vertically expands to the expanded configuration.

In certain embodiments, which further comprises variable-volume pouch, and the variable-volume is small Bag can be positioned in the internal volume of the Invasive lumbar fusion device.

In certain embodiments, which further comprises cable is unfolded, which is connected to In the detour main body and it is configured for the detour main body applying power to make the detour main body from the non-expanded configuration It is converted to the expanded configuration.

In certain embodiments, which further comprises expansion instrument, which is connected to In the detour main body and it is configured for the detour main body applying power to make the detour main body from the non-expanded configuration It is converted to the expanded configuration.

In certain embodiments, the expansible Invasive lumbar fusion device be configured to be positioned between the soleplate of two pieces of vertebras and It is further configured to never expanded configuration and is converted to expanded configuration, so as to causes the size and shape of the expansible Invasive lumbar fusion device What shape changed and increased the expansible Invasive lumbar fusion device changes internal volume.

In another aspect of the present invention, it is a kind of to be used to manufacture and using the use for being used to be placed between adjacent vertebrae The method that 3D can print the specific expansible Invasive lumbar fusion device of the patient with hinges of material, this method include：Operating The preceding adjacent vertebrae to the patient is imaged to generate 3D imaging datas；The 3D data are supplied to 3D printer；Use One or more 3D can print the expansible Invasive lumbar fusion device of file printing, which includes detour main body, should Detour main body has the multiple side segments being rotatably attached by Integral type movable hinge, these Integral type movable hinges are configured Into the flexure during making the detour main body never expanded configuration be converted to expanded configuration or deform；Can by this in a manner of surgery Extension Invasive lumbar fusion device is positioned between these adjacent vertebraes；And make the expansible Invasive lumbar fusion device these adjacent vertebraes it Between from the non-expanded configuration expand to the expanded configuration.

In certain embodiments, one or more 3D materials are selected from the group being made of the following：Thermoplasticity Plastics；Photopolymer；Metal dust；Eutectic metal；Titanium alloy；Examples of natural biocompatible materials；Synthesising biological compatibility material Material；Biocompatible metal material；Adaptive material；4D printed materials；Polyether-ketone (PEK)；Polyetherimide (PEI), such as Ultem；Ultra-high molecular weight polyethylene (UHMPE)；Polyphenylene；Polyether-ether-ketone (PEEK), including memory PEEK materials, such as As PEEK Altera；And combinations thereof.

It is a kind of to be used for expansion for be beaten using 3D between being placed on adjacent vertebrae in further aspect of the invention The system of the expansible Invasive lumbar fusion device with hinges of material is printed, which includes：Expansible Invasive lumbar fusion device, this can Extension Invasive lumbar fusion device can print material by one or more 3D and be made, which is configured to never extend Configuration is converted to expanded configuration, has proximally and distally, which includes detour main body, detour main body tool There are the multiple side segments being rotatably attached by Integral type movable hinge, these Integral type movable hinges are configured to make this circuitous Return during main body is converted to the expanded configuration from the non-expanded configuration and bend or deform；And variable-volume pouch, this can Variable volume pouch can be positioned in the Invasive lumbar fusion device, which is configured for making the expansible intervertebral fusion Device is moved to the expanded configuration from the non-expanded configuration.

Brief description of the drawings

With reference to attached drawing, book and appended claims, the foregoing and other feature of present disclosure will become more according to the following instructions Add clear.Understand that these attached drawings depict only some embodiments according to present disclosure and be not construed as limiting it Scope, more precisely and will describe present disclosure in detail by using these attached drawings.

Figure 1A is the perspective view of one embodiment of the Invasive lumbar fusion device in non-expanding location.

Figure 1B is the top view of one embodiment of the Invasive lumbar fusion device in non-expanded configuration.

Fig. 2A is the perspective view of one embodiment of the Invasive lumbar fusion device in expanded configuration.

Fig. 2 B are the top views of one embodiment of the Invasive lumbar fusion device in expanded configuration.

Fig. 3 is the flow chart of 3D model Method of printings.

Fig. 4 A are the perspective views of one embodiment of the variable-volume pouch in non-expanded configuration.

Fig. 4 B are the perspective views of one embodiment of the variable-volume pouch in expanded configuration.

Fig. 5 A are the Invasive lumbar fusion device equipment for including Invasive lumbar fusion device and variable-volume pouch in non-expanded configuration The perspective view of one embodiment.

Fig. 5 B are the side views of one embodiment of connector.

Fig. 6 A are one of the Invasive lumbar fusion device equipment for including Invasive lumbar fusion device and variable-volume pouch in expanded configuration The perspective view of a embodiment.

Fig. 6 B are the top-sectional views of one embodiment of the Invasive lumbar fusion device equipment in expanded configuration.

Fig. 7 is one of the Invasive lumbar fusion device equipment for including variable-volume pouch and Invasive lumbar fusion device in expanded configuration The perspective view of embodiment, the Invasive lumbar fusion device have lateral crevasse.

Fig. 8 is the schematic diagram of one embodiment of development system.

Fig. 9 is a reality of the Invasive lumbar fusion device equipment for including Invasive lumbar fusion device and cable being unfolded in non-expanded configuration Apply the perspective view of example.

Figure 10 A are a realities of the Invasive lumbar fusion device equipment for including Invasive lumbar fusion device and cable being unfolded in expanded configuration Apply the perspective view of example.

Figure 10 B are a realities of the Invasive lumbar fusion device equipment for including Invasive lumbar fusion device and cable being unfolded in expanded configuration Apply the top view of example.

Figure 11 is the intervertebral fusion for including variable-volume pouch, expansion cable and Invasive lumbar fusion device in expanded configuration The perspective view of one embodiment of device equipment, the Invasive lumbar fusion device have lateral crevasse.

Figure 12 is the stream shown for using Invasive lumbar fusion device and/or one embodiment of the process of Invasive lumbar fusion device equipment Cheng Tu.

Figure 13 is to show a kind of variable-volume pouch and intervertebral fusion used as a part for Invasive lumbar fusion device equipment The flow chart of one embodiment of the method for device.

Figure 14 is show a kind of method using the Invasive lumbar fusion device equipment for including Invasive lumbar fusion device and cable being unfolded one The flow chart of a embodiment.

Figure 15 A are the perspectives of one embodiment of the Invasive lumbar fusion device equipment with distal side aperture in non-expanding location Figure.

Figure 15 B are the section views along the section A-A shown in Figure 15 A of one embodiment of Invasive lumbar fusion device equipment.

Figure 15 C are that the section along section B-B as shown in fig. 15b of one embodiment of Invasive lumbar fusion device equipment regards Figure, it shows the slit on the aperture of distal side.

Figure 16 A can be used for Invasive lumbar fusion device equipment never expanded position being transformed into the implanting instrument of expanded position The fragmentary sectional view of one embodiment.

Figure 16 B are the amplifications of the distal end of one embodiment of the implanting instrument in the section A-A focused on as shown in Figure 16 A View.

Figure 16 C be from the view in terms of the distal end of one embodiment of the implanting instrument with connector, tusk and axis, It shows the distal end of Invasive lumbar fusion device equipment.

Figure 17 is one embodiment and an implementation of implanting instrument for the Invasive lumbar fusion device equipment with distal side aperture The section view of example before proceeding.

Figure 18 is the perspective view of the one embodiment that can extend Invasive lumbar fusion device vertically.

Figure 19 A are that the Invasive lumbar fusion device of Figure 18 is in the side front view of first position.

Figure 19 B are that the Invasive lumbar fusion device of Figure 18 is in the side front view of the second place.

Figure 19 C are that the Invasive lumbar fusion device of Figure 18 is in the side front view of the third place.

Embodiment

Word " nearside " and " distal side " are applied to the specific end for indicating the component of present invention described herein.Near-end is The end nearer from medical professional when component is implanted of finger.Distal end be finger when component is implanted from The end of medical professional farther out.

Although provided herein is a kind of some details of expansible Invasive lumbar fusion device, can be found in the following into The details of one step：Entitled " the Intervertebral Device and Methods of Use submitted on April 5th, 2012 The US publication 2012/0083887 of [intervertebral device and application method] "；On April 5th, 2012 submits entitled " the US publication 2012/0083889 of Intervertebral Device and Methods of Use "；And 2014 Entitled " Vertically Expandable the Intervertebral Cage, Deployment that October 2 announced The international publication number WO2014/158619 of Devices, And Methods Of Using The Same ", all of which is with it It is incorporated herein in full by quoting.

The application discloses one kind and can be expanded by increasing material manufacturing (also referred to as 3 D-printing or 3D printing) come what is manufactured Open up Invasive lumbar fusion device.3D printing is can be deposited by printer sample loading mode in the various types of of powder, liquid or particle form The high speed increases material manufacturing technology of material.The layer of deposition can successively cure, or alternately, deposit, can make for particle Exfoliated particles agent is fixed together in granule bed with intermediate adhesion step, and then can for example using laser or Multiple layers are solidified togather by photocuring.

As used herein, 3D printing includes the printing technique of many types, such as increasing material manufacturing, quick manufacture, layering Manufacture, rapid prototyping manufacturing, laser sintered, electron beam melting (EBM) etc..3D printing further includes adaptive material and 4D printing. In certain embodiments, 4D prints the length to the Invasive lumbar fusion device printed using increasing material manufacturing, width and height addition time. By adding the time, Invasive lumbar fusion device can become adaptability, change structure：Self-evolution structure.

A use of feature of 3D printing technique is to recognize：Expansible Invasive lumbar fusion device be not necessarily limited by it is conventionally manufactured about Those that beam, such as conventional mechanical are processed or casting method is forced.The 3D printing technique of expansible Invasive lumbar fusion device can make With different materials, including thermoplastic, photopolymer, metal dust, eutectic metal, titanium alloy and other materials.

The 3D printing technique of expansible Invasive lumbar fusion device can use different materials, including thermoplastic, photo polymerization Thing, metal dust, eutectic metal, titanium alloy and other materials.Because expansible Invasive lumbar fusion device will be implanted in vivo, Preferred material is biocompatible materials, such as examples of natural biocompatible materials, synthesising biological compatibility material, metal biofacies Capacitive material, adaptive material and/or any other desirable biocompatible materials.Implant can be by the following system Into：Polyether-ketone (PEK)；Polyetherimide (PEI), such as Ultem；Ultra-high molecular weight polyethylene (UHMPE)；Polyphenylene；It is poly- Ether-ether -one (PEEK), including memory PEEK materials, such as PEEK Altera；Or any other desirable bio-compatible Property material.3D printing technique can also include mixing material and design, i.e. PEEK and titanium.

In certain embodiments, expansible Invasive lumbar fusion device can be manufactured using 3D printing technique, wherein with opposite Highdensity metal material is deposited in the polymeric substrates with relative low density.In certain embodiments, expansible intervertebral Fusion device can be manufactured so that side segment can print material by the 3D of relative stiffness and be made and Integral type movable hinge is by phase Material is can print to flexible 3D to be made.Other combinations can include for the metal of side segment and Integral type movable hinge, gather Any combinations of compound, ceramics or compound.In certain embodiments, expansible Invasive lumbar fusion device can use conventionally manufactured work The combination of skill and 3D printing technique manufactures.

Invasive lumbar fusion device can also include external coating, for example, plasma spray coating, hydroxyapatite coating layer, biological agent, Antibiotic, medicine or gene therapy, nanometer technology platform etc..Coating can be the part of 3D printing technique or secondly be applied in Or it is incorporated into implant.

The 3D printing technique of expansible Invasive lumbar fusion device can also relate to patient specifically and/or patient is engineered implantation Thing.By this kind of system, expansible Invasive lumbar fusion device can obtain non-according to before operation from the patient of experience surgical operation Invasive imaging data designs, and is manufactured using this anatomic information to adapt to the individual dissection structure of patient.Pass through So do, it is not necessary to store the deposit fusion device of a variety of sizes before the surgery as currently being done so that save the time and Money.

Invasive lumbar fusion device described herein can be " space is unknowable " in the sense：It can be used for a variety of ridges Column integration technology, including anterior lumbar interbody fusion (ALIF), posterior lumbar intervertebral fusion (PLIF), transforaminal lumbar Intervertebral fusion (TLIF), outside lumbar vertebrae intervertebral fusion (XLIF) or the spinal fusion techniques in any direction applied, including Through bone spinal fusion techniques.

Present invention relates in general to interbody spinal fusion implant, and more particularly to be configured for recover simultaneously Two pieces of adjacent vertebraes of backbone are maintained to be in the Invasive lumbar fusion device of correct anatomic angle relation.Invasive lumbar fusion device is arranged to It is positioned at non-expanded configuration between the soleplate of two pieces of vertebras, and then expands to expanded configuration, so as to causes intervertebral fusion The size and dimension of device changes.Invasive lumbar fusion device helps to merge opposing vertebra while maintains lordosis.

Figure 1A and 1B and Fig. 2A and 2B shows one embodiment of expansible Invasive lumbar fusion device 100.Invasive lumbar fusion device 100 It may be configured to be positioned between two pieces of vertebras, and be definitely positioned between the soleplate of two pieces of vertebras, for making phase To spinal fusion.Invasive lumbar fusion device 100 can be positioned with such as Figure 1A and 1B discribed non-expanded configuration, and can be with such as Fig. 2A and 2B discribed expanded configurations position.In certain embodiments, and as Figure 1A and 1B and 2A and 2B describe, The change of the never expanded configuration of Invasive lumbar fusion device 100 to expanded configuration can cause the size and dimension of Invasive lumbar fusion device 100 to change Become.

Invasive lumbar fusion device 100 can include the detour main body 102 for limiting periphery and internal volume.Main body 102 can by with It is set to and is positioned in two pieces of vertebras therebetween for contacting Invasive lumbar fusion device 100, and/or power is determined from Invasive lumbar fusion device 100 One piece in the vertebra of position therebetween is delivered to another piece that Invasive lumbar fusion device is positioned in vertebra therebetween.Main body 102 can To include the various shapes and sizes of the size between approximate two pieces of vertebras, and can be by various material systems Into.

As seen in Figure 1A and 1B and Fig. 2A and 2B, the embodiment of main body 102 can include segment 116, these sections Section is connected to by monoblock type flexible connector or hinges 118 can change inner volume 126 to be formed each other.Hinges 118 need not to be true hinge, because they be able to need not bend many times, but can only be enough robusts never to extend Configuration bends to expanded configuration once.

In certain embodiments, on the inner surface for the neighbouring internal volume 126 that hinges 118 can be located at main body 102, And in certain embodiments, hinges 118 can be located on the outer surface of main body 102.In certain embodiments, moveable hinge Chain 118 can be configured for curved part including main body 102.In certain embodiments, hinges 118 can be Discrete elements, because bending is probably to localize in one or several positions in main body 102, and in some implementations In example, hinges 118 can be with right and wrong discrete elements, because bending may not be localization, but in the whole of main body 102 Or occur on big part.In some embodiments of wherein hinges 118 including discrete elements, flexible connector can be with Shape, feature, material property or any other aspect including concentrated stress and/or deformation.Such as Figure 1A and 1B and 2A and 2B Definitely described, in certain embodiments, hinges 118 can include the narrowed portion of main body 102 and/or to main body Notch in 102, to allow the Deformation Localization of main body 102 when the never expanded configuration of main body 102 is moved to expanded configuration.

Main body 102 can have near-end 110 and distal end 112.In certain embodiments, near-end 110 and/or distal end 112 can To be the integral part of main body 102, and it can partly limit the internal volume of main body 102.In certain embodiments, and As finding, the near-end 110 of main body 102 can include nearside aperture 124 in fig. 2.In certain embodiments, for example, proximal aperture Mouth 124 can extend through the near-end 110 of main body 102 and extend in the internal volume 126 of main body 102.Advantageously, wherein Nearside aperture 124 extends through the near-end 110 of main body 102 and extends in the embodiment in the internal volume 126 of main body 102, Nearside aperture 124 can provide the portion in the internally positioned volume 126 for leading to internal volume 126 and/or Invasive lumbar fusion device equipment The path of part or feature.Near-end 110 can include various shapes and sizes.Similarly, nearside aperture 124 can include Various shapes and sizes.

The distal end 112 of main body 102 is configured for promoting Invasive lumbar fusion device 100 being inserted between the vertebrae. In some embodiments, for example, the distal end 112 of main body 102 can include tapered and/or pointed shape, to promote main body 102 It is inserted between vertebra.Advantageously, this tapered and/or pointed shape to the distal end of main body 102 can promote to realize vertebra Between be sufficiently separated, and/or can make the main body 102 of Invasive lumbar fusion device 100 being inserted into the space between vertebra and want The insertion force asked minimizes.

As finding, the longitudinal axis 104 of main body 102 can prolong between the near-end 110 of main body and distal end 112 in figure ia Stretch.As further finding, main body 102 can include top 120 and bottom 122 in figure ia.In certain embodiments, top 120 and bottom 122 can each be arranged to be positioned in the interaction of one of vertebra therebetween with Invasive lumbar fusion device 100, And definitely it is used for an interaction being positioned in Invasive lumbar fusion device 100 in the soleplate of one of vertebra therebetween.Such as Equally finding, main body 102 can limit perpendicularly to the longitudinal axis 104 and in the top 120 of main body 102 and bottoms in figure ia The vertical axis 108 extended between 122.As further finding, main body 102 can limit perpendicularly to the longitudinal axis in figure ia The lateral axes 106 of both 104 and vertical axis 108 extension.

As seen in Figure 1A and 1B and 2A and 2B, the combination of segment 116 and hinges 118 allows Invasive lumbar fusion device 100 main body 102 is unfolded, and the expansion reduces near-end 110 and distal end the distance between 112 and increases such as laterally axis The width of main body 102 measured by 106.

Segment 116 and hinges 118 can include various shapes and sizes.In certain embodiments, for example, The shapes and sizes of segment 116 and/or hinges 118 can be by the desirable size, desirable of Invasive lumbar fusion device 100 Expansion power, the gained shape of desirable extension, desirable non-expanded configuration, and/or other several Considerations determine.

Main body 102 can be manufactured using known increasing material manufacturing or 3D printing method.For example, main body 102 can be by giving birth to Thing compatibility material constructs layer by layer, from bottom to up, so that segment 116 is entirely connected by hinges 118.Main body 102 can be fabricated at not separated main body in the case of the single single piece that can not dismantle.The single-piece can pass through 3D printing Technique manufactures.Similar building technology increasing material manufacturing is known with following title：Increasing material manufacturing, quick manufacture, layering Manufacture, rapid prototyping manufacturing, laser sintered, electron beam melting (EBM) etc..These building technology are all former using similar operation Reason：Excitation beam is scanned on material bath to solidify the exact pattern of material, so that each layer is formed, it is whole until completing Untill component.M of the present invention

In certain embodiments, Invasive lumbar fusion device 100 may be configured so that when Invasive lumbar fusion device 100 never extends structure When type is moved to expanded configuration, the size of Invasive lumbar fusion device 100 along one in axis 104,106,108 discussed above, Two or three change.

Fig. 3 shows one embodiment of 3D printing process flow chart.Data used in manufacture fusion device can use The predefined data of fusion device size, or the imaging data obtained using the patient from experience surgical operation.Data can be From software program, the geometric representation for the data format generation 3D physical models which is supported with 3D printer, and And geometric representation is sent to 3D printer to create 3D physical models.

3D printer needs the geometric representation of object, and geometry required in 3D physical models is made to build. The typical geometric representation of object can include one of following form or its combination：Row 3D points of the whole main body of object, Defined position and material information at wherein each 3D points；A group 3D for limiting shape of the object on each plane of delineation takes turns It is wide；Or the surface model being made of triangle or polygon, or sketch the contours the surface patch of the main body of object.

The 3D physical models of fusion device can have one or more parts and an one or more colors, and can be by One or more materials are made.The transfer process of the geometric representation understood from input image data collection to 3D printer can take Certainly in or independently of image mode or any other image information.The process may be implemented as computer, computer disposal Software program on the controller board of plate or 3D printer.It may be implemented as but is not limited to：With process instruction and parameter Procedure script file, there is process instruction and parameter binary executable, dynamic link storehouse (DLL), using journey Sequence plug-in unit or print apparatus driver.Print data program can locally load on 3D printer computer or resident On the remote server connected by computer network.

Once receiving data, 3D printer just prints fusion device, and then fusion device can be sent to operating room To be implanted in patient's body.

Variable-volume pouch

Some embodiments of Invasive lumbar fusion device equipment can include variable-volume pouch.Fig. 4 A are depicted at not extending shape The perspective view of one embodiment of the variable-volume pouch 400 of state, and Fig. 4 B are depicted at the variable-volume of extended mode One embodiment of pouch 400.Variable-volume pouch 400 can be arranged to small in variable-volume in response to receiving material Extended in the interior section of bag 400.In certain embodiments, variable-volume pouch 400 is configured for variable Volume pouch 400 resists compression stress when being filled with material.One example of variable-volume pouch is from the limited public affairs of Spineology Obtained by departmentDeployable implant system.Although provided herein is the one of variable-volume pouch 400 and application method A little details, but further details can be found in the following：Entitled " the Expandable that March 1 nineteen ninety-five announces Fabric Implant For Stabilizing the Spinal Motion Segment [are used to make spinal motion segment steady Fixed expansible fabric implant] " U.S. Patent number 5,549,679；And entitled " the use that on November 5th, 1996 announces In make spinal motion segment stablize expansible fabric implant " U.S. Patent number 5,571,189, both of which is led to its full text Cross to quote and be incorporated herein.

Variable-volume pouch can include various shapes and sizes.In certain embodiments, for example, variable-volume Pouch 400 allows variable when can be shaped so as in the interior section that material is added to variable-volume pouch 400 Volume pouch 400 extends.In certain embodiments, for example, variable-volume pouch can be almost spherical, it is avette, elongated , it is cylindrical, rectangle, or there is any other desirable shape.It is variable in the discribed embodiment of Fig. 4 A and 4B The only approximate balloon of volume pouch 400.As equally finding, variable-volume pouch 400 include first end in figures 4 a and 4b Portion 402 and the second end 404 being reversed in position with first end 402.Such as finding in figures 4 a and 4b, variable-volume pouch 400 further comprise the single opening 406 at first end 402.

In certain embodiments, variable-volume pouch 400 can include the optional sealing for being configured to permit opening 406 And/or the feature of closing.These features can include for example, one or some tether panels, one or some drawstrings, one or Several connectors are configured to permit the sealing of opening 406 and/or any other machinery the or other feature of closure.

Variable-volume pouch 400 can include various materials.In certain embodiments, variable-volume pouch can be with Comprising natural material, synthetic material, artificial material, polymer, composite material, elastic material, non-elastic material and/or it is any its His desirable material.In certain embodiments, and as Fig. 4 A and 4B describe, variable-volume pouch 400 can be included and knitted Producing material material.Advantageously, weaving material can allow variable-volume pouch 400 to expand to desirable largest amount.

Variable-volume pouch 400 can include various sizes.In certain embodiments, variable-volume pouch 400 It can be sized to allow to be placed between two pieces of vertebras.Definitely, in certain embodiments, variable-volume pouch 400 can be sized to coordinate between two pieces of vertebras and definitely to coordinate between the soleplate of two pieces of vertebras.

Invasive lumbar fusion device equipment

Fig. 5 A depict the perspective view of one embodiment of Invasive lumbar fusion device equipment 500.Invasive lumbar fusion device equipment 500 includes Invasive lumbar fusion device 100 and the variable-volume pouch 400 in the internal volume 126 of Invasive lumbar fusion device 100.In some embodiments In, variable-volume pouch 400 can be attached in all or part of Invasive lumbar fusion device 100.In certain embodiments, example Such as, variable-volume pouch 400 can be inserted into the internal volume 126 of Invasive lumbar fusion device 100, so that variable-volume is small Bag 400 the second end 404 is adjacent to the distal end 112 of Invasive lumbar fusion device 100 and first end 402 is adjacent to Invasive lumbar fusion device 100 Near-end 110., can in wherein first end 402 in some advantageous embodiments of the near-end 110 of Invasive lumbar fusion device 100 The opening 406 of variable volume pouch 400 is positioned adjacent to the nearside aperture 124 of the main body 102 of Invasive lumbar fusion device 100.Therefore, exist In some embodiments, variable-volume pouch 400 can be inserted into the main body 102 of Invasive lumbar fusion device 100 by nearside aperture 124 Internal volume 126 in.In such an embodiment, in variable-volume pouch 400 main body is inserted into via nearside aperture 124 After in 102 internal volume 126, variable-volume pouch 400 can be attached to Invasive lumbar fusion device 100 partially or completely In main body 102.In certain embodiments, variable-volume pouch 400 can be attached in the main body 102 of Invasive lumbar fusion device 100, So so that the extension of variable-volume pouch 400 can cause the main body 102 of Invasive lumbar fusion device 100 to be unfolded, and in some realities Apply in example, attaching in the main body 102 of variable-volume pouch 400 to Invasive lumbar fusion device 100 can cause variable-volume pouch 400 Extended when the main body 102 of Invasive lumbar fusion device 100 extends.

In certain embodiments, Invasive lumbar fusion device equipment 500 may further include connector 502.Connector 502 can by with It is set to for being sealingly fitted in nearside aperture 124 to seal nearside aperture, by the first end of variable-volume pouch 400 402 are fixed on the near-end 110 of Invasive lumbar fusion device 100, and seal the opening 406 of variable-volume pouch.In some embodiments In, connector 502 can be further configured to the expansion for promoting Invasive lumbar fusion device 100.Connector 502 can include various each The shapes and sizes of sample, and can be made of various materials, these materials include intervertebral fusion can for example be made The all material of device 100.

In certain embodiments, connector 502 can include proximal shaft 504 and distal head 506.Proximal shaft 504 can wrap Include various shapes and sizes.In certain embodiments, proximal shaft 504 can be sized near to seal with shape Side opening mouth 124, and can definitely be sized with shape into having larger size compared with nearside aperture 124.One In a little embodiments, there is proximal shaft 504 configuration of the size of bigger compared with the size in nearside aperture 124 can promote connector 502 are maintained in nearside aperture 124.

In certain embodiments, distal head 506 can include various shapes and sizes.In some embodiments In, distal head 506 can be cone shape, have distal base 508 and in the side of proximal shaft 504 upwardly toward vertex Extension.Distal head 506 can be shaped, in certain embodiments, to promote that Invasive lumbar fusion device 100 is unfolded.

Fig. 6 A are depicted at one embodiment of the Invasive lumbar fusion device equipment 500 of expanded configuration, wherein Invasive lumbar fusion device 100 main body 102 extends and wherein variable-volume pouch 400 is in its expanded configuration.Such as finding in fig. 6, in its expansion The internal volume 126 of Invasive lumbar fusion device 100 is filled and/or be substantially filled with to the variable-volume pouch 400 of exhibition configuration.

Fig. 6 B are the sectional top views of the Invasive lumbar fusion device equipment 500 in expanded configuration.Such as finding in fig. 6b, connector 502 proximal shaft 504 is located in the nearside aperture 124 of the main body 102 of Invasive lumbar fusion device 100.Such as same finding in fig. 6b, insert The proximal shaft 504 of plug has extended the diameter in nearside aperture 124, and is therefore fixed in nearside aperture 124.As equally Finding in fig. 6b, connector 502 are positioned in nearside aperture 124, so that the first end of variable-volume pouch 400 402 part is located between proximal shaft 504 and the wall in nearside aperture, so that fixed variable-volume pouch 400.

The distal head 506 that Fig. 6 B further illustrate connector 502 extends to the internal volume 126 of Invasive lumbar fusion device 100 In.Such as finding, distal head 506 are just engaging the part of main body 102 in fig. 6b, so that the main body 102 of Invasive lumbar fusion device 100 Biased towards expanded configuration.

In some embodiments of Invasive lumbar fusion device equipment 500 using connector 502 are wherein combined, variable-volume pouch 400 It can be inserted into by nearside aperture 124 in Invasive lumbar fusion device 100 and be positioned such that the of variable-volume pouch 400 One end 402 and opening 406 are adjacent to nearside aperture 124.In certain embodiments, variable-volume pouch 400 can be by least portion It is attached on Invasive lumbar fusion device 100 with dividing.Be inserted into Invasive lumbar fusion device 100 in variable-volume pouch 400, be positioned and After being attached at least in part on Invasive lumbar fusion device 100 if desired, variable-volume pouch can be filled and/or Invasive lumbar fusion device 100 can be expanded.

Fig. 7 depicts the alternate embodiment of Invasive lumbar fusion device equipment 500.Definitely, Fig. 7 depicts Invasive lumbar fusion device equipment In 500 one embodiment, the Invasive lumbar fusion device equipment be included in be shown at extended mode in the diagram can variation Product pouch 400 and the Invasive lumbar fusion device 300 for including lateral crevasse 302 for being shown at its complete expanded configuration.Such as exist Seen in fig. 7, Invasive lumbar fusion device 300 not only extended on the lateral 106 that such as laterally axis 106 measures, but also such as edge And extended on the vertical direction of the measurement of vertical axis 108.Such as finding in the figure 7, variable-volume pouch 400 be substantially filled with and/ Or the internal volume 126 of filling Invasive lumbar fusion device 300.

Development system

Some embodiments are related to for being inserted into and being unfolded Invasive lumbar fusion device equipment 500 and/or Invasive lumbar fusion device 100,300 System and device (being described further on Figure 11).Fig. 8 depicts one embodiment of insertion development system 800.Such as exist Seen in fig. 8, development system 800 can include expansion instrument 802.Expansion instrument 802 is configured for promoting intervertebral The insertion of fusion device equipment 500 and/or Invasive lumbar fusion device 100,300 and Invasive lumbar fusion device equipment 500 and/or intervertebral is controlled to melt The expansion of clutch 100,300.

Expansion instrument 802 can include various shapes and sizes, and can include various features. In some embodiments, for example, expansion instrument 802 can be mechanical device, electromechanical assembly and/or electric device.In some implementations Example in, for example, expansion instrument 802 can be manual operation, can be electrical control, and/or can be using it is any its What his desirable control technology controlled.As depicted in fig. 8, expansion instrument 802 includes control interface 804.Control interface 804 can To be configured to permit user's control expansion instrument 802 and Invasive lumbar fusion device equipment 500 and/or Invasive lumbar fusion device 100,300 Insertion and/or expansion.In certain embodiments, for example, control interface can include being configured for receiving user's input And using that input come realize Invasive lumbar fusion device equipment 500 and/or Invasive lumbar fusion device 100,300 expansion any feature, System, and/or module.As depicted in fig. 8, control interface 804 can include being configured for one to expansion cable 806 The simplified manual control of end applying power.

In certain embodiments, expansion instrument 802 can combine other features and be used for being inserted into Invasive lumbar fusion device 100,300. In this kind of embodiment, expansion instrument 802 can be used together with stiff shaft.In one embodiment, stiff shaft can include The near-end being attached on expansion instrument 802, and it is configured for the distal end engaged with Invasive lumbar fusion device 100,300. In some embodiments, it is configured for engaging with Invasive lumbar fusion device 100,300 and is located at these of the far-end of stiff shaft One or several skewers that feature can include being configured for the part of engagement Invasive lumbar fusion device 100,300 (do not show Go out).In certain embodiments, it is configured for that optionally Invasive lumbar fusion device 100,300 is attached on expansion instrument 802 Feature can allow any bar along and/or in the axis 104,106,108 of Invasive lumbar fusion device 100,300 manipulate and Mobile Invasive lumbar fusion device 100,300.

In certain embodiments, stiff shaft may be configured to allow expansion cable 806 passing to vertebra from expansion instrument 802 Between fusion device 100,300.In certain embodiments, cable 806 is unfolded can be along stiff shaft and/or through stiff shaft from expansion Instrument 802 passes to Invasive lumbar fusion device 100,300.Expansion cable 806 passes to Invasive lumbar fusion device 100,300 from expansion instrument 802 can To be promoted by one or several passages in stiff shaft.In certain embodiments, these rigid crossings can be located at firm On the outer surface of property axis, and/or in stiff shaft.In certain embodiments, passage can extend the whole length of stiff shaft, And/or extend along the part of stiff shaft.

Wherein expansion instrument 802 be only used for expansion Invasive lumbar fusion device 100,300 some embodiments in, one and/or Multiple separated insertion instruments can be used for being inserted into Invasive lumbar fusion device 100,300.This insertion instrument and/or implanting instrument some Embodiment can be found in the US publication 2012/0083887 that on April 5th, 2012 announces, and this application is passed through with its full text Quote and be incorporated herein.

Expansion cable 806 is configured for power being delivered to Invasive lumbar fusion device equipment 500 from expansion instrument 802 And/or Invasive lumbar fusion device 100,300.In certain embodiments, expansion cable 806 is configured for promoting intervertebral fusion Device equipment 500 and/or Invasive lumbar fusion device 100,300 and/or expansion, so as to promote to maintain Invasive lumbar fusion device equipment 500 and/or Invasive lumbar fusion device 100,300 is in expanded configuration.In certain embodiments, expansion cable 806 can be arranged to be used as mark Note, and definitely, may be used as position for indicating Invasive lumbar fusion device 100,300 and/or definite Invasive lumbar fusion device 100, 300 marks that are whether expanded and having spread over which kind of degree.In certain embodiments, for example, expansion cable 806 can be with Feature including regular intervals, these features can be by allowing to determine expansion cable 806 in Invasive lumbar fusion device 100,300 Length and allow to determine which kind of degree whether Invasive lumbar fusion device 100,300 extend and/or expand to because in certain embodiments The expansion of Invasive lumbar fusion device 100,300 can change the size of Invasive lumbar fusion device 100,300, so determining expansion cable 806 Length in the part in Invasive lumbar fusion device can promote to determine whether Invasive lumbar fusion device 100,300 extends and/or what is expanded to Kind degree.

Expansion cable 806 can include various shapes and sizes, and various materials can be by being made. The all or part of expansion instrument can be manufactured by 3D printing.In certain embodiments, cable 806, which is unfolded, can include appointing What shapes and sizes, and can by can apply and bear to be unfolded Invasive lumbar fusion device equipment 500 and/or Invasive lumbar fusion device 100, Any material of power necessary to 300 is made.

As depicted in fig. 8, expansion cable 806 includes first end 808 and the second end 810.In certain embodiments, One end 808 can include attachment features 812.Attachment features 812 can be arranged to allow expansion cable 806 being attached to In a part for Invasive lumbar fusion device 100,300 and/or prevent expansion cable 806 relative to Invasive lumbar fusion device 100,300 at one Or any feature that several designated parties move up.

Attachment features 812 can include various shapes and sizes, and can be made of various materials. In one embodiment, for example, attachment features 812 can include allowing attachment features 812 to engage Invasive lumbar fusion device 100,300 Therefore a part simultaneously limits shape and/or size of the expansion cable 806 relative to the movement of Invasive lumbar fusion device 100,300.Such as exist Definitely finding in Fig. 8, in certain embodiments, attachment features can include at the first end 808 of expansion cable 806 Spherical characteristic.

In certain embodiments, expansion cable 806 can include breakaway poing (not shown).In certain embodiments, it is broken Point can be unfolded cable 806 be configured for when more than force threshold disconnect, be broken, and/or separated part.One In a little embodiments, the force threshold of breakaway poing, which can be less than, will cause other parts and/or feature (cable 806 such as, to be unfolded Attachment features 812 and/or lock-in feature 814) fracture or failure force threshold.In certain embodiments, breakaway poing can be determined For example it is being unfolded between lock-in feature 814 and the second end 810 of cable 806 position.Advantageously, because power higher than force threshold Application causes expansion cable 806 to be broken at breakaway poing, so this positioning of breakaway poing can be eliminated in Invasive lumbar fusion device 100th, the needs of the 300 expanded expansion cables 806 of cutting afterwards.

As equally finding, the second end 810 of expansion cable 806 may be coupled to one of expansion instrument 802 in fig. 8 On point.Such as further finding in fig. 8, in certain embodiments, expansion cable 806 further comprises lock-in feature 814, the lock Determining feature can be for example at any position along expansion cable, and in certain embodiments, positioned at expansion cable 806 Attachment features 812 and the second end 810 between.Lock-in feature 814 may be configured to allow user by Invasive lumbar fusion device 100th, 300 lock and/or be fixed under expanded configuration.In certain embodiments, lock-in feature 814 can include being configured to use In the part interaction with Invasive lumbar fusion device 100,300 and therefore prevent Invasive lumbar fusion device 100,300 in Invasive lumbar fusion device 100th, the 300 expanded size and/or shape for returning to non-expanded configuration afterwards.

In certain embodiments, for example, the distance between attachment features 812 and lock-in feature 814 can change.Definitely Ground, for example, the distance between attachment features 812 and lock-in feature 814 can the size based on Invasive lumbar fusion device 100,300, exhibitions Open distance, and/or any other desirable parameter that cable 806 must move before the expansion of Invasive lumbar fusion device 100,300 Change.

Fig. 9,10A and 10B depict the perspective view of one embodiment of Invasive lumbar fusion device equipment 900.Definitely, Fig. 9 is retouched One embodiment of the Invasive lumbar fusion device equipment 900 in non-expanded configuration is painted, and Figure 10 A and 10B are depicted at expanding Open up the perspective view of one embodiment of the Invasive lumbar fusion device equipment 900 of configuration.As seen in Fig. 9,10A and 10B, intervertebral fusion Device 100 can be arranged to be used together with cable 806 is unfolded.In certain embodiments, for example, Invasive lumbar fusion device 100 can With one or several openings of the part including being configured for receiving, guide, and/or hold expansion cable and/or One or several passages.These openings can include various shapes and sizes, and can be located at Invasive lumbar fusion device Any desirable part on.In certain embodiments, the size and shape of opening can be by feature (example that opening is accommodated Such as picture, expansion cable 806, attachment features 812, and/or lock-in feature 814) size and shape determine.Definitely, for example, vertebra Between the main body 102 that can include neighbouring Invasive lumbar fusion device 100 of fusion device 100 one or several distal sides that position of distal end 112 Opening 902, and the first proximal open 906 and/or the second proximal open of the positioning of near-end 110 of neighbouring Invasive lumbar fusion device 100 908。

Distal openings 902, the first proximal open 906 and the second proximal open 908 are configured for reception exhibition Open a part for cable 806.In certain embodiments, for example, distal openings 902, the first proximal open 906 and/or second are near Side opening 908 is all or the part that cable 806 enters and leaves Invasive lumbar fusion device 100 is unfolded in some of can guide. In some embodiments, these openings 902,906,908 may be coupled to all or part of one through Invasive lumbar fusion device 100 Or on several passages.Therefore, in certain embodiments, expansion cable can enter intervertebral by the first proximal open 906 In fusion device 100, and through Invasive lumbar fusion device 100 all or part of after, expansion cable 806 and then can be via Another opening (such as, 902 and/or second proximal open 908 of distal openings) leaves the passage in Invasive lumbar fusion device 100.

Such as further finding in fig.9, in certain embodiments, expansion cable 806 can be to pass through Invasive lumbar fusion device 100 The internal volume 126 of main body 102.Definitely, in certain embodiments, all or part of cable 806, which is unfolded, to be merged Distal openings 902 are extended to from the first proximal open 906 and/or distally opening 902 extends to the beside the inner surface of device 100 Two proximal opens 908.

In certain embodiments, single Invasive lumbar fusion device 100,300 can be combined and use more expansion cables 806.One In a little embodiments, the quantity of cable 806, which is unfolded, to be determined by desirable expansion type.Therefore, in certain embodiments, may be used To realize more complicated expansion campaign using more expansion cables 806.

Figure 11 depicts one embodiment using more expansion cables.Definitely, Figure 11 depicts Invasive lumbar fusion device and sets Standby 1100 another embodiment.Such as finding, Invasive lumbar fusion device equipment 1100 include Invasive lumbar fusion device 300 in fig. 11, should Invasive lumbar fusion device includes the main body 102 with near-end 110 and distal end 112.Main body 102 limit along the center of main body 102 and The longitudinal axis 104 extended between near-end 110 and distal end 112.The main body 102 of Invasive lumbar fusion device 300 further comprises by activity Multiple segments 116 that hinge 118 links, limit internal volume 126 and top 120 and the bottom 122 of main body, and be limited to Between top 120 and bottom 122 and it is perpendicularly to the longitudinal axis 104 extension vertical axis 108.The master of Invasive lumbar fusion device 300 Body 102 further limits the lateral axes 106 of both perpendicularly to the longitudinal axis 104 and vertical axis 108 extension.

As equally finding, the main body 102 of Invasive lumbar fusion device 300 include lateral crevasse 302 in fig. 11.Lateral crevasse 302 It may be configured to the extension for allowing the main body 102 of Invasive lumbar fusion device 300.In certain embodiments, for example, lateral crevasse 302 All or part of for the main body 102 that may be configured to allow Invasive lumbar fusion device 300 is perpendicular to the direction of lateral crevasse 302 Upper extension.Lateral crevasse 302 includes first end 304 and the second end 306.The first end 304 of lateral crevasse 302 is neighbouring main The distal end 112 of body 102 positions, and the second end 306 of lateral crevasse 302 is located approximately in the middle part of main body 102.Laterally Main body 102 is divided into top section 308 and base section 310 by crack 302 at least in part.Advantageously, lateral crevasse 302 is passed through Main body 102 is divided into top section 308 and base section 310 allows the main body 102 of Invasive lumbar fusion device 300 to extend.In some realities Apply in example, for example, this extension of the main body 102 of Invasive lumbar fusion device 300 can be perpendicular to lateral crevasse 302, and at some In embodiment, this extension of main body 102 can be not orthogonal to lateral crevasse 302.The top section 308 of main body 102 and bottom Part 310 allows main body 102 to be extended up by the extension of lateral crevasse 302 in the side parallel to lateral axes 106.

As further finding, Invasive lumbar fusion device 300 further comprise the first proximal open of lower part 1102, lower part in fig. 11 Second proximal open 1104, the first proximal open of top 1106, the second proximal open of top 1108, lower distal opening 1110, And top distal openings 1112.

As equally finding, Invasive lumbar fusion device equipment 1100 include two expansion cables 806 in fig. 11.Figure 11 is discribed One in expansion cable 806 is inserted into by the first proximal open of lower part 1102 and then passes through variable-volume pouch 400, At the variable-volume pouch, which is left by one 1110 at least one lower distal opening, afterwards again Through the variable-volume pouch and reach the second proximal open of lower part 1104.This path of cable 806 is unfolded by variable-volume A part for pouch 400 is fixed on Invasive lumbar fusion device 300, and is definitely fixed to the base section of Invasive lumbar fusion device 300 On 310.

Through the first proximal open of top 1106 and then such as same finding in fig. 11, another expansion cable 806 At least one 1112 in the distal openings of top are reached through variable-volume pouch, again pass through variable-volume pouch afterwards simultaneously Reach the second proximal open of top 1108.Similar to the expansion cable 806 through lower openings 1102,1104,1110, through upper A part for variable-volume pouch 400 is fixed to Invasive lumbar fusion device 300 by the expansion cable 806 of portion's opening 1106,1108,1112 On, and definitely on the top section 308 fixed to Invasive lumbar fusion device 300.Advantageously, variable-volume pouch 400 arrives top Fixation on part 308 and base section 310 allows the interior section by filling variable-volume pouch 400, variable to use Volume pouch 400 Invasive lumbar fusion device 300 is vertically unfolded at least in part relative to vertical axis 108.

Although Figure 11 depict wherein using two expansion cable 806 embodiments and show opening 1102,1104, 1106th, 1108,1110,1112 specific location, those skilled in the art will recognize that, Invasive lumbar fusion device 300 can be combined Using any amount of expansion cable 806, and the diversified position of opening can be used.

Use the method for Invasive lumbar fusion device equipment

Figure 12 is the process shown for using Invasive lumbar fusion device 100,300 and/or Invasive lumbar fusion device equipment 500,1100 The flow chart of 1200 one embodiment.The process since square frame 1210, wherein for example by remove fibrous ring a part, Empty core and then remove cartilage endplate and come preparing intervertebral disc space.

After intervertebral disc space is got out, process 1200 proceeds to square frame 1212, wherein by Invasive lumbar fusion device 100,300 It is placed into intervertebral disc space.In one embodiment, Invasive lumbar fusion device 100,300 is made to be rotated simultaneously around its longitudinal axis 104 Place it in intervertebral disc space, so that the vertical axis 108 of the main body 102 of Invasive lumbar fusion device 100,300 parallel to Endplate.

Process 1200 proceeds to square frame 1214, wherein making Invasive lumbar fusion device 100,300 around its longitudinal axis 104 rotation 90 Degree.After Invasive lumbar fusion device 100,300 is rotated, top 120 and bottom 122 contact endplate.Intervertebral fusion wherein The distance between top 120 and bottom 122 of the main body 102 of device 100,300 are more than such as parallel to measured by lateral axes 106 In some embodiments of the width of the main body 102 of Invasive lumbar fusion device 100,300, main body 102 is along 90 degree of its longitudinal axis 104 The height of rotation increase intervertebral disc space.

Making Invasive lumbar fusion device 100,300, process 1200 proceeds to square frame after its longitudinal axis 104 is rotated by 90 ° 1216, wherein making the extension of Invasive lumbar fusion device 100,300 be limited to increase by main body 102 and in certain embodiments by being formed The internal volume 126 that the segment 116 of main body 102 and hinges 118 limit.In certain embodiments, Invasive lumbar fusion device 100, 300 extension can briefly carry out (as Figure 14 describes) such as step 1406.

In certain embodiments, extend main body 102, untill main body 102 reaches expanded configuration.For example wherein tying Expansion instrument 802 is closed using in some embodiments of Invasive lumbar fusion device 100,300, the actuating of expansion instrument 802 can cause vertebra Between fusion device 100,300 expansion, and therefore cause Invasive lumbar fusion device 100,300 extension and Invasive lumbar fusion device 100, The extension of 300 internal volume 126.Invasive lumbar fusion device 100,300 is included by memory material (such as, PEEK wherein AlteraTM in some embodiments of main body 102 made of), Invasive lumbar fusion device 100,300 can by trigger memory material with So that the second place that Invasive lumbar fusion device 100,300 never extends transforms to the first position of extension to extend.In some implementations In example, triggering can be temperature-induced, stress induced, electric and/or mechanical induction, chemical induction, and/or pass through What any other trigger mechanism carried out.In particular embodiments, triggering can be in the threshold more than Invasive lumbar fusion device 100,300 It is induced during value temperature or when surmounting the stress threshold of Invasive lumbar fusion device 100,300.

After intervertebral device extension is made to increase the internal volume 126 limited by main body 102, process 1200 is at some May be advanced to square frame 1218 in embodiment, wherein intervertebral device is locked using locking mechanism (cable 806 such as, is unfolded) Under expanded configuration.The step of although process 1200 can include square frame 1218 in certain embodiments, this square frame can Square frame 1220 may be advanced to omission and process 1200.

Process 1200 may then advance to square frame 1220, wherein filling Invasive lumbar fusion device 100,300 with bone grafting material Main body 102 internal volume 126, to allow the bone fusion between adjacent vertebrae.In certain embodiments, can be via position Fill the master of Invasive lumbar fusion device 100,300 in nearside aperture 124 in the near-end 110 of the main body 102 of Invasive lumbar fusion device 100,300 The internal volume 126 of body 102.

Those skilled in the art will recognize that the step of aforementioned process, can be performed by same order or different order. Those skilled in the art will be further appreciated that, process 1200 can include with it is outlined above compared with those more or more Few step.

Figure 13 is the flow chart for showing one embodiment for the process 1300 using Invasive lumbar fusion device equipment 500. In some embodiments, the part of process 1300 can perform before Invasive lumbar fusion device equipment 500 is inserted into interbody space, And in certain embodiments, the part of process 1300 can be held after Invasive lumbar fusion device equipment is inserted into interbody space OK.

Process 1300 is since square frame 1302, wherein variable-volume pouch 400 is inserted into Invasive lumbar fusion device 100,300 In.In certain embodiments, for example, variable-volume pouch 400 is inserted into Invasive lumbar fusion device 100,300 can use it is various The instrument of various kinds and technology perform.In certain embodiments, for example, can be via the main body 102 of Invasive lumbar fusion device 100,300 Near-end 110 in nearside aperture 124 variable-volume pouch is inserted into Invasive lumbar fusion device 100,300.In some embodiments In, variable-volume pouch 400 can be inserted into via the nearside aperture 124 in the near-end 110 of Invasive lumbar fusion device 100,300 Into the internal volume 126 of Invasive lumbar fusion device 100,300.In certain embodiments, variable-volume pouch 400 can be inserted in advance Enter into Invasive lumbar fusion device 100,300, and process 1300 can be since the square frame outside square frame 1302.

After variable-volume pouch 400 is inserted into Invasive lumbar fusion device 100,300, process 1300 and then advance To square frame 1304, wherein the opening 406 of variable-volume pouch 400 to be positioned adjacent to the proximal aperture of Invasive lumbar fusion device 100,300 Mouth 124.In certain embodiments, the opening 406 of variable-volume pouch 400 is positioned adjacent to Invasive lumbar fusion device 100,300 Nearside aperture 124 can for example be accomplished by the following way：The second end 404 of variable-volume pouch 400 is inserted through closely Side opening mouth 124, is inserted through nearside aperture 124 by the first end 402 of variable-volume pouch 400 afterwards.Inserted by following this Enter operation, and the second end 404 of variable-volume pouch 400 is therefore inserted through nearside aperture 124, variable-volume first The opening 406 at the first end 402 of variable-volume pouch 400 of pouch 400 can easily be positioned adjacent to vertebra Between fusion device 100,300 nearside aperture 124.Wherein variable-volume pouch 400 be previously inserted to Invasive lumbar fusion device 100, In some embodiments in 300, process 1300 can be since square frame 1304.In certain embodiments, variable-volume pouch 400 Opening 406 can be pre-positioned into the nearside aperture 124 of neighbouring Invasive lumbar fusion device 100,300, and process 1300 can be with Square frame outside square frame 1304.

The opening 406 of variable-volume pouch 400 is being positioned adjacent to the nearside aperture of Invasive lumbar fusion device 100,300 After 124, process 1300 proceeds to square frame 1306, wherein variable-volume pouch 400 is attached to Invasive lumbar fusion device 100,300 On.In certain embodiments, for example, variable-volume pouch 400 can be attached to whole or the portion of Invasive lumbar fusion device 100,300 On point, and definitely, in all or part for the main body 102 for being attached to Invasive lumbar fusion device 100,300.In some embodiments In, for example, variable-volume pouch 400 can be attached to intervertebral fusion along the part of the restriction internal volume 126 of main body 102 In the main body 102 of device 100,300.Definitely, the part of variable-volume pouch 400 can be attached to the section for forming main body 102 In section 116 and hinges 118.

In certain embodiments, the feature being located in the main body 102 of Invasive lumbar fusion device 100,300 can be utilized (such as, One or several fasteners, one or several hooks, one or several buckle, one or several adhesion areas, and/or Any other institute in any one of main body 102 of variable-volume pouch 400 and Invasive lumbar fusion device 100,300 or both Desired feature) variable-volume pouch 400 is attached in the main body 102 of Invasive lumbar fusion device 100,300.In some embodiments In, for example, can by be not variable-volume pouch 400 or Invasive lumbar fusion device 100,300 main body 102 integral part In addition variable-volume pouch 400 is attached on Invasive lumbar fusion device 100,300 by feature.In certain embodiments, these features can With including such as one or some expansion cable 806.In certain embodiments, for example, can will expansion cable 806 merge with Just variable-volume pouch 400 is attached on Invasive lumbar fusion device 100,300.In particular embodiments, cable can will be unfolded Line 806 is inserted through a part (such as, main body 102) for Invasive lumbar fusion device 100,300, is inserted through variable-volume pouch 400 part, and then again insertable into the part through Invasive lumbar fusion device 100,300.In certain embodiments, exhibition is made Cable 806 is opened through the part of Invasive lumbar fusion device 100,300 and passes through the part of variable-volume pouch 400 can be by variable-volume Pouch 400 is fixed on Invasive lumbar fusion device 100,300.

In certain embodiments, variable-volume pouch 400 can be connected to vertebra along the whole periphery of internal volume 126 Between on fusion device 100,300, and in certain embodiments, variable-volume pouch 400 can be connected to vertebra at discrete point Between on fusion device 100,300.In certain embodiments, can be in 1 point, 2 points, 3 points, 4 points, 5 points, 6 points, 8 A point, 10 points, 20 points, connect at 50 points or at any other or the point of middle quantity by variable-volume pouch 400 It is connected on Invasive lumbar fusion device 100.Be previously inserted into Invasive lumbar fusion device 100,300 in wherein variable-volume pouch 400 and The opening 406 of wherein variable-volume pouch 400 has been positioned adjacent to the nearside aperture 124 of Invasive lumbar fusion device 100,300 In some embodiments, process 1300 can be since square frame 1306.In certain embodiments, variable-volume pouch 400 can be by It is attached in advance on Invasive lumbar fusion device 100,300, and process 1300 can be since the square frame outside square frame 1306.Wherein The assembling of Invasive lumbar fusion device equipment 500 with the use of Invasive lumbar fusion device equipment 500 some embodiments separated in time, mistake Journey 1300 can terminate in square frame 1306.

Process 1300 wherein Invasive lumbar fusion device equipment 500 assembling in time adjacent to Invasive lumbar fusion device equipment 500 Some embodiments used in, after variable-volume pouch 400 is attached on Invasive lumbar fusion device 100,300, process 1300 may be advanced to square frame 1308, wherein extending Invasive lumbar fusion device 100,300.In certain embodiments, square frame 1308 can To be for preparing the process of interbody space and for before being inserted into the process of Invasive lumbar fusion device equipment 500.At some In embodiment, these processes can include some or all of steps of the discribed processes 1200 of such as Figure 12.

In certain embodiments, Invasive lumbar fusion device 100,300 can use any desirable expansion technique and/or expansion Device extends.In particular embodiments, for example, Invasive lumbar fusion device, which can use, includes expansion instrument 802 and expansion cable The development system 800 of line 806 extends.In certain embodiments, the expansion of Invasive lumbar fusion device 100,300 can cause intervertebral to melt Clutch 100,300 as surveyed along one or more in longitudinal axis 104, lateral axes 106, and/or vertical axis 108 The size of amount changes.

After Invasive lumbar fusion device 100,300 is extended, process 1300 proceeds to square frame 1310, wherein filling variable-volume Pouch 400.In certain embodiments, for example, variable-volume can be filled via the opening 406 at variable-volume pouch 400 Pouch 400.In certain embodiments, can via variable-volume pouch 400 opening 406 and positioned at Invasive lumbar fusion device 100, Variable-volume pouch is filled in nearside aperture 126 in 300 near-end 110.In certain embodiments, such as gaseous state material can be used Material, liquid material, and/or solid-state material fill variable-volume pouch.In certain embodiments, can be filled out with graft materials Variable-volume pouch 400 is filled, which can include such as solid-state material and definitely include polylith solid-state material. In some embodiments, these materials can include the osteocomma and/or bone piece, and/or any biocompatible materials of bone.

In certain embodiments, variable-volume pouch 400 can be filled with the membrane material of desirable amount.In some realities Apply in example, the desirable amount of membrane material can be desirable when its extended mode is in based on variable-volume pouch 400 Size.Therefore, in certain embodiments, the desirable size of the extended mode of variable-volume pouch 400 can determine membrane material The amount of material.After variable-volume pouch 400 is had been filled with, it can take steps to packing material maintaining variable-volume In pouch 400.In certain embodiments, these steps can include such as sealed opening 406, closing opening 406, clog opening 406 or any other action that will prevent membrane material from emptying from variable-volume pouch 400.

Figure 14 is an implementation for showing the process 1400 for preparing and/or using Invasive lumbar fusion device equipment 900,1100 The flow chart of example, the Invasive lumbar fusion device equipment can have or can not have variable-volume pouch 400.In some embodiments In, process 1400 can perform before Invasive lumbar fusion device equipment 900,1100 is inserted into interbody space, and at some In embodiment, process 1400 can perform after Invasive lumbar fusion device equipment is inserted into interbody space.

Process 1400 is since square frame 1402, wherein expansion cable 806 is inserted through the near of Invasive lumbar fusion device 100,300 End 110.In certain embodiments, for example, by the way that expansion cable 806 is inserted through the first proximal open 906,1104,1108 Expansion cable 806 is inserted through to the near-end 110 of Invasive lumbar fusion device 100,300.In certain embodiments, it is inserted through The expansion cable 806 of one proximal open 906,1104,1108 passes through the near-end 110 of Invasive lumbar fusion device 100,300 and enters intervertebral In the internal volume 126 of fusion device 100,300.In certain embodiments, it is inserted into the first proximal open 906,1104,1108 In expansion cable 806 enter passage in and through Invasive lumbar fusion device 100,300 all or part.In certain embodiments, Expansion cable 806 can be previously inserted near-end 110 through Invasive lumbar fusion device 100,300, and process 1400 can be from side Square frame outside frame 1402 starts.In certain embodiments, without will expansion cable 806 be inserted through Invasive lumbar fusion device 100, 300 near-end 110, but be simply attached or be attached at the near-end 110 of Invasive lumbar fusion device 100,300 or near it.

After expansion cable 806 is inserted through the near-end 110 of Invasive lumbar fusion device 100,300 or is attached to it, mistake Journey 1300 is moved to square frame 1304, and expansion cable 806 is inserted through to the distal end 112 of Invasive lumbar fusion device 100,300.One , can be by the way that expansion cable 806 to be inserted into distal openings 902,1110,1112 and/or be inserted through this in a little embodiments Distal openings are inserted into cable 806 is unfolded in the distal end 112 of Invasive lumbar fusion device 100,300.Expansion cable 806 is worn wherein Cross the near-end 1110 of Invasive lumbar fusion device 100,300 and enter in some embodiments in internal volume 126, can be from internal volume 126 are inserted into distal end 112 via distal openings 902,1110,1112 by cable 806 is unfolded.Wherein be unfolded cable 806 from First proximal open 906,1104,1108, can be by through travelling across intervertebral fusion through in some embodiments of passage The passage of the distal end of device is inserted through the distal end 1112 of Invasive lumbar fusion device 100,300 by cable 806 is unfolded.Cable is unfolded wherein Line 806 is previously inserted through in some embodiments of the near-end 110 of Invasive lumbar fusion device 100,300, and process 1400 can be with Since square frame 1404.In certain embodiments, expansion cable 806 can be previously inserted through Invasive lumbar fusion device 100,300 Distal end 112, and process 1400 can be since the square frame outside square frame 1404.Wherein Invasive lumbar fusion device equipment 900, 1100 assembling with the use of Invasive lumbar fusion device equipment 900,1100 some embodiments separated in time, process 1400 can To terminate at square frame 1404.

In certain embodiments, after expansion cable 806 is inserted through the distal end 112 of Invasive lumbar fusion device 100,300, Expansion cable 806 can be made to return to the near-end 110 of Invasive lumbar fusion device 100,300.In certain embodiments, by the way that cable will be unfolded Line 806 is inserted into the second distal openings 902,1110,1112 and/or is inserted through second distal openings, and cable 806 is unfolded It may return to the distal end 110 of Invasive lumbar fusion device 100,300.The second distal openings are had been inserted into expansion cable 806 902nd, in 1110,1112 and/or be inserted through after second distal openings, expansion cable 806 through Invasive lumbar fusion device 100, 300 distal end 112 simultaneously enters in the internal volume 126 of Invasive lumbar fusion device 100,300.In certain embodiments, it is inserted into remote Expansion cable 806 in side opening 902,1110,1112 enters whole or the portion in passage and through Invasive lumbar fusion device 100,300 Point.

, can be by the way that cable will be unfolded after near-end 110 of the expansion cable 806 back to Invasive lumbar fusion device 100,300 806 are inserted through the second proximal open 908,1102,1106 is inserted through Invasive lumbar fusion device 100,300 by cable 806 is unfolded Near-end 110.In certain embodiments, the expansion cable 806 of the second proximal open 908,1102,1106 is inserted through from vertebra Between fusion device 100,300 internal volume 126 spread out of and through Invasive lumbar fusion device 100,300 near-end 110.In some embodiments In, expansion cable 806 can be previously inserted near-end 110 through Invasive lumbar fusion device 100,300.In certain embodiments, nothing The near-end 110 of Invasive lumbar fusion device 100,300 need to be inserted through by cable 806 is unfolded, but simply can be attached or be attached in vertebra Between fusion device 100,300 near-end 110 at or its near.

, can after expansion cable 806 is inserted through the near-end 110 of Invasive lumbar fusion device 100,300 or is attached to it With will expansion cable 806 be connected on expansion instrument 802, the expansion instrument then can be used for be unfolded Invasive lumbar fusion device 100, 300。

Set in time adjacent to Invasive lumbar fusion device in the assembling of the wherein Invasive lumbar fusion device equipment 900,1100 of process 1400 In standby 900,1100 some embodiments used, process 1400 proceeds to square frame 1406, wherein by via expansion cable 806 Apply force to extend Invasive lumbar fusion device 100,300 to Invasive lumbar fusion device 100,300.Via expansion cable 806 to intervertebral fusion The power that device 100,300 applies can use various instruments and/or technology to generate.It is in such as wherein expansion cable 806 In some embodiments of the part of insertion system 800 including expansion instrument 802, it can be tensed by using control interface 804 Expansion cable 806 comes via expansion cable 806 to Invasive lumbar fusion device 100,300 applying powers.In certain embodiments, and when through During from expansion cable 806 to Invasive lumbar fusion device 100,300 applying power, feedback is provided a user via expansion instrument 802 to permit Family allowable understands the state of expansion.Definitely, in certain embodiments, expansion instrument 802 is configured for user There is provided and indicate to Invasive lumbar fusion device 100,300 applying powers will further cause that Invasive lumbar fusion device 100,300 is locked in extension structure Feedback under type.In certain embodiments, for example, this feedback can include instruction Invasive lumbar fusion device 100,300 approach lockings And/or the audible of expanded configuration, vision and/or haptic signal.In certain embodiments, square frame 1406 can be for preparing The process of interbody space and for being inserted into before the process of Invasive lumbar fusion device equipment 900,1100.In certain embodiments, These processes can include some or all of steps of the discribed processes 1200 of such as Figure 12.

By extending Invasive lumbar fusion device 100,300 to Invasive lumbar fusion device 100,300 applying powers via expansion cable 806 Afterwards, process 1400 proceeds to square frame 1408, wherein Invasive lumbar fusion device 100,300 is locked under expanded configuration.Open up wherein Open in some embodiments that cable 806 includes lock-in feature 814, can be by using the lock-in feature 814 on expansion cable 806 Invasive lumbar fusion device 100,300 is locked under expanded configuration.It is special using locking how Invasive lumbar fusion device 100,300 can be combined In the specific embodiment that Invasive lumbar fusion device 100,300 is locked under expanded configuration by sign 814, lock-in feature can include With the size of bigger and/or the component of diameter compared with the diameter of cable 806 is unfolded.Making, expansion cable 806 from second is near When the retraction of side opening 908,1104,1108 is to be unfolded Invasive lumbar fusion device 100,300, lock-in feature 814 can move through vertebra Between fusion device 100,300 near-end 110 and leave the second proximal open 908,1104,1108.Lock-in feature 814 is used wherein Invasive lumbar fusion device 100,300 is locked in some embodiments in extension and/or locked configuration, the second proximal open 908, 1104th, 1108 it may be configured to allow lock-in feature 814 through the near-end 110 of Invasive lumbar fusion device 100,300 and leave second Proximal open 908,1104,1108, but prevent lock-in feature 814 to be retracted back through the second proximal open 908,1104,1108 and return Into the near-end 110 of Invasive lumbar fusion device 100,300.Therefore, in certain embodiments, once via the second proximal open 908th, 1104,1108 the near-end 110 of lock-in feature from Invasive lumbar fusion device 100,300 is recalled, lock-in feature can be with second The part of proximal open 908,1104,1108 is engaged so as to which Invasive lumbar fusion device 100,300 is fixed on locking and/or expanded configuration Under.In certain embodiments, after Invasive lumbar fusion device 100,300 is locked under expanded configuration, power threshold can be exceeded It is worth, and cable 806 is unfolded to be broken at breakaway poing.In certain embodiments, it is in lock in Invasive lumbar fusion device 100,300 After under fixed and/or expanded configuration, it can will be filled via nearside aperture 124 and/or graft materials are inserted into Invasive lumbar fusion device 100th, in the internal volume 126 of 300 main body 102.

Those skilled in the art will recognize that process 1300 and 1400 can be included with outlined above compared with those More or less steps.Those skilled in the art will be further appreciated that, the step of process 1300 and 1400 outlined above Suddenly it can be performed by any desirable order, and sub-step or subprocess can be included.Those skilled in the art will be into One step is recognized, the ad hoc approach that Invasive lumbar fusion device 100,300 is locked under expanded configuration is not limited to enumerate herein specific Embodiment, but Invasive lumbar fusion device 100,300 can be locked in extension and/or lock using diversified technology and device Determine in configuration.Those skilled in the art will be further appreciated that the discribed process in Figure 12,13 and 14 can combine, And therefore Invasive lumbar fusion device 100,300 both can be used together with variable-volume pouch 400 and expansion cable 806.

Figure 15 A-15C are the diagrams of one embodiment of Invasive lumbar fusion device equipment 1500, which has Positioned at the distal side aperture 1502 of the far-end of main body 102.With reference to figure 15A (it is the perspective view of Invasive lumbar fusion device equipment 1500), Distal side aperture 1502 is centered on longitudinal axis 104, although in alternative embodiments, aperture 1502 can be inclined with axis 104 From.In the shown embodiment, distal side aperture 1502 have compared with the diameter in nearside aperture 124 less diameter, and along Its inner surface merges coupling mechanism.In certain embodiments, coupling mechanism takes the form of bayonet attachment.Such as Figure 15 B, (it is Section view of the Invasive lumbar fusion device equipment 1500 along section A-A (in Figure 15 A show)) shown in, distal side aperture can have Two or more slits 1504, two or more slits are configured for receiving implanting instrument 1600 (relative to figure 16A-16C is described further) distal end on two or more pins 1618.

In the shown embodiment, slit 1504 is " L-shaped " slit along the inner surface formation in distal side aperture, so that The near-end in the Part I of slit distally aperture 1502 is extended between the near-end in aperture 1502 and distal end towards distal side Position.As Figure 15 C (it be Invasive lumbar fusion device equipment 1500 along the section view of section B-B (in Figure 15 B show)) are more clear Show to Chu, the Part II of slit 1504 is radially extended then along the inner periphery of the inner surface in distal side aperture.Radially extend Can be about 45 degree to about 135 degree around longitudinal axis 104.In the shown embodiment, circumferentially extending can be about 90 degree. In some embodiments, less or more slit 1504 can be used.In addition, in certain embodiments, slit 1504 can be by It is positioned so that the Part I of slit 1504 is centered in the plane formed by axis 104 and 108.This can be advantageouslyed allow for Using the pin 1618 of bigger, so that localized stresses and strain when reducing expanding unit.

In other embodiments, the slit 1504 in distal side aperture 1502 does not have Part II, so that Part I Entirely the near-end from aperture 1502 extends to the distal end in aperture 1502, so as to allow pin 1618 fully to extend there through. In this kind of embodiment, the pin 1618 of implanting instrument can alternatively for engage and adjacent Invasive lumbar fusion device equipment 1500 it is remote Side 1505.In other embodiment again, distal side aperture 1502 has the diameter of the diameter equal to or more than nearside aperture 124. Moreover, it is contemplated that in other embodiments, implanted device and main body 102 can be coupled using other kinds of coupling mechanism, Such as, but not limited to pressure cooperation, interference engagement, frictional fit, screw thread and other coupling mechanisms as known in the art.

With reference to figure 15B, the near-end 110 of main body 102 has notch 1506, these notch are configured for receiving Figure 16 A- The mating section 1608 of implanting instrument 1600 shown in 16C.In the shown embodiment, two notch 1506 are along near-end 110 Neighboring positions.In other embodiments, notch 1506 can be used and be not limited to along the outer of the near-end 110 of main body 102 Place on periphery.

Figure 16 A-16C can be used for Invasive lumbar fusion device equipment 1500 described herein or other fusion device equipment never Expanded position is transformed into the diagram of one embodiment of the implanting instrument 1600 of expanded position.With reference to figure 16A, (it is implanting instrument The partial section of 1600 one embodiment), implanting instrument 1600 has to be extended between the near-end of instrument 1600 and distal end And it is centered in the outer tube 1602 on tube chamber axis 1604.It is connector 1606 in the far-end of outer tube 1602, should Connector is configured for the near-end 110 of contact main body 102.Such as Figure 16 C (it is the view of the distal end of implanting instrument 1600) It is shown more clearly that, in one embodiment, connector 1606 has the size of the near-end 110 equal to or more than main body 102 Size, so that any contact is advantageously distributed on the whole surface region of near-end 110 by connector 1606. In some embodiments, connector 1606 has two 1608 (such as dentations of mating section protruded from connector 1606 towards distal side Thing), in the notch 1506 on near-end 110 that the two mating sections are configured to need to be inserted into main body 102 and engage this A little notch.In other embodiments, connector 1606 can have less or more mating section 1608, this depends on main body The amount of notch 1506 on 102 near-end 110.Once engagement, mating section 1608 is configured to for by the rotation of main body 102 Turn the rotation with outer tube 1602 directly to connect, so as to provide during implant surgery to the user of implanting instrument 1600 The rotating of main body 102 is directly controlled.

What it is in the proximal end of outer tube 1602 is shank 1610, which is configured for by the use of implanting instrument 1600 Hold at family.Shank 1610 is attached directly on outer tube 1602, so that the rotation of shank 1610 also causes outer tube 1602 rotation.In this way, the user of implanting instrument 1600 can control the rotation of main body 102 advantageous by shank 1610.Plant Entering instrument 1600 also has the inner shaft 1612 to center around tube chamber axis 1604, which can in outer tube 1602 Enough slideably translations can slideably rotate again.In the shown embodiment, inner shaft 1612 is attached directly to control structure On part 1614, so that the rotation and translation of control member 1614 makes 1612 rotation and translation of inner shaft.In this embodiment, Control member 1614 is fully received in the aperture 1616 in shank.In other embodiments, aperture be sized with Just inner shaft 1612 is only received, so that control member 1614 is maintained at outside shank.Control member 1614 can have auxiliary Help elevated convex ridge, protuberance, texture, grasping part or other mechanisms of user's rotation and translation control member 1614 of device.

In certain embodiments, it is pin 1618 in the far-end of axis, these pins and is located at Invasive lumbar fusion device equipment The coupling mechanism in 1504 form of slit on 1500 distal side aperture 1502 is corresponding.Because axis 1612 is in outer tube 1602 It can slideably translate and can slideably rotate, so axis 1612 can not only be translated but also be rotated to just engage remote " L-shaped " slit 1504 of side opening mouth 1502, simultaneously because mating section 1608 engages with notch 1506 and via outer tube 1602 Apply reaction force to main body 102.

Figure 17 shows a kind of method, in this way, can be using implanting instrument 1600 come by intervertebral described herein Fusion device equipment 1500 and any other this kind equipment never expanded position are converted to expanded position.In the shown embodiment, make With the axis 1612 with pin 1618 and the Invasive lumbar fusion device equipment 1500 with the distal side aperture 1502 containing slit 1504. During first step, by implanting instrument 1600 towards the near-end of the Invasive lumbar fusion device equipment 1500 in non-expanded configuration 110 promote, so that connector 1606 is placed adjacent to the near-end 110 of main body 102 and is in contact with it.It is advanced at this Cheng Zhong, mating section 1608 are inserted into notch 1506 and engage these notch at the same time, thus by the rotation of main body 102 with The rotatable communication of outer tube 1602 gets up.

During second step, axis 1612 is slidably then advanced through outer tube 1602 towards distal side and is advanced to vertebra Between in fusion device equipment 1500.Axis is advanced through nearside aperture 124 first, then passes through internal volume 126, and finally put It is set to the trailing edge in neighbouring distal side aperture 1502 and is in contact with it.In this embodiment, because distal side aperture 1502 has and axis The corresponding slit 1504 of pin 1618 of 1612 far-end, so axis 1612 can be by following the profile quilt of slit 1504 It is propelled further into distal side aperture 1502.Then can be with rotation axis 1612, so that axis 1612 connects with distal side aperture 1502 Close.In this bonding station, axis 1612 and main body 102 are connected, so that the translation of axis 1612 causes main body 1502 translation.Retouched herein it should be noted that being used only for describing a kind of expansion labeled as " first " and " second " by above step The Invasive lumbar fusion device equipment 1500 and the method for other fusion device equipment stated.In other embodiments, this can anti-mistake along show Come, so that second step is completed before first step.

There is the implementation of the slit 1504 along the whole length extension in distal side aperture 1502 in Invasive lumbar fusion device equipment 1500 In example, axis is fully advanced through distal side aperture 1502.When pin 1618 is located at the distal side of the distal face 1505 of main body 102 When, rotate and axis 1612 of retracting is so that pin 1618 abuts distal face 1505.

In addition, above-mentioned steps can be held before Invasive lumbar fusion device equipment 1500 is inserted into interbody space or afterwards OK.In wherein above-mentioned steps in the embodiment performed before being inserted into interbody space, implanting instrument 1600 can be used Device is delivered in the space., can be with the embodiment performed after wherein above-mentioned steps are being inserted into interbody space Device is delivered in the space using separated instrument.

During third step, after axis 1612 is engaged with distal side aperture 1502, at holding shaft 1612 While appropriate place, in a distal direction to 110 applying power of near-end of main body 102.Proximally 110 power applied are due to edge The deformation of hinges 118 and cause the never expanded position of main body 102 to be transformed into expanded position.In alternative embodiments, exist While outer tube 1602 is kept in appropriate place, in a proximal direction to the distal end of main body 102 at distal side aperture 1502 Applying power, so as to which the never expanded position of main body 102 is transformed into expanding location.

During final step, rotation axis 1612 is to take off pin 1618 and " L-shaped " slit in distal side aperture 1502 From engagement.Then axis 1612 is slidably retracted from Invasive lumbar fusion device equipment 1500, so that axis 1612 is moved from main body 102 Remove.Then connector 1606 can be retracted, so that mating section 1608 is removed from notch 1506.Then can be by work Tool is removed from interbody space and the body of patient.

Vertical expansible Invasive lumbar fusion device

Figure 18 is the diagram of one embodiment of the Invasive lumbar fusion device 1800 in expanded configuration.Invasive lumbar fusion device 1800 has There are both front panel 1802 and detour main body 1805.Under expanded configuration, front panel 1802 is configured in the form of pillar Structural support is provided for fusion device 1800.In one embodiment, front panel 1802 is included away from top edge 1812 and bottom sides Front panel 1802 is subdivided into top section 1816a and bottom by the hinges 1810 that edge 1814 equidistantly positions, the hinges Section 1816b.In other embodiments, hinges 1810 can be placed with from top edge 1812 or from bottom margin 1814 closer to this depends on desirable geometry under non-expanded configuration and expanded configuration.In addition, in other embodiment again In, a hinges are can comprise more than on front panel 1802.

In certain embodiments, top section 1816a and bottom section 1816b is rotatably attached at hinge 110 To form the separative element of front panel 102.In those embodiments, top section 1816a and bottom section 1816b's revolves Turning attachment can be by allowing the material of elastic deformation to realize, the hinge or front panel that are such as formed via the thickness of reduction 1802 along hinges 1810 hinges, which is configured to permit along hinges 1810 and deforms.

In one embodiment (all as shown in figure 18 those), front panel 1802 has substantially on front panel 1802 Aperture 1818 placed in the middle.In other embodiments, front panel 1802, which has, is located at top section 1816a and bottom section 1816b Multiple apertures on both.Aperture 1818 may be configured to allow the distal part of implanted device to pass through Invasive lumbar fusion device 1800 Rear end 1808 enter through aperture 1818, so that the distal part of implanted device is located at the distal side of front panel 1802. On top section 1816a and bottom section 1816b in the embodiment with multiple apertures, these apertures may be configured to permit Perhaps seal wire is inserted through by the rear end 1808 of Invasive lumbar fusion device 1800 by the first aperture and is returned it to by the second aperture Rear end 1808.Implanted device or seal wire can be used for applying power so as to which the never expanded configuration of Invasive lumbar fusion device 1800 is transformed into expansion Open up configuration.

, can will be in the internally placed volume of inflatable apparatus such as inflatable bladder as another example.It can fill Device of air can be inflated, so that inflatable apparatus increases in internal volume in volume.Inflatable apparatus can connect Touch the part of Invasive lumbar fusion device 1800, so that power is applied on Invasive lumbar fusion device so as to which fusion device 1800 is unfolded.It is this kind of Method and apparatus are described in more detail in U.S. Patent Application No. 14/422,750, and the entire disclosure of which is by quoting It is incorporated herein.

In the shown embodiment, top section 1816a and bottom section 1816b generally has rectangular shape, in spite of Aperture 1818.In this configuration kind, top edge 1812 and the generally keeping parallelism of bottom margin 1814.In other embodiment In, top section and bottom section are not rectangular shapes, but wedge-type shape, so that top edge 1812 and bottom Edge 1814 is not parallel.These embodiments can be inclined on two surfaces for needing to support and different height is required When use.Other shapes can include quadrangle, such as, but not limited to square, rectangle, parallelogram and trapezoidal.Shape It can also include with more than part-ellipticals such as the polygons of four edges, semicircles and as can be as this area Any other shape that technical staff selects.

It should be apparent to a person skilled in the art that the panel of Invasive lumbar fusion device 1800 can by using hinges and with phase Proximal surface plate forms integral unit, or can separate with adjacent cells and be rotatably attached via above-mentioned attachment means.At this In some embodiments of device, while use both hinges and other attachment means.This permissible assembling after fabrication should Device and potentially provide cost savings.In other embodiments, hinges are used throughout whole device.

Operation

As discussed above, the panel of Invasive lumbar fusion device 1800 and section are rotatably attached to adjacent via hinges On panel and section.In this way, the separated panel of Invasive lumbar fusion device 1800 never expanded configuration can rotate to expanded configuration.Figure 19A-19C is from the view in terms of the left side of Invasive lumbar fusion device 1800, shows that Invasive lumbar fusion device 1800 is never extended structure by one kind Type is transformed into the non-limiting method of expanded configuration.Show three kinds of separated configurations：Non- expanded configuration (is shown in fig. 19 a Go out), neutral configuration (showing in fig. 19b) and expanded configuration (being shown in Figure 19 C).

With reference to figure 19A, when in non-expanded configuration, front panel 1802 is collapsed, so that top section 1816a The side of wedge shape is formed with bottom section 1816b, wherein hinges 1810 form the tip of wedge shape.In other embodiments, side Panel is inwardly collapsed.In the shown embodiment, hinges 1810 stretch out in a distal direction, so as to Invasive lumbar fusion device 1800 provide wedge-type shapes or tapered front end 1806.During implant surgery, since front panel 1802 is intervertebral fusion Device 1800 enters operative site and the initial part of vertebral interspace, so wedge-type shape or tapered configuration promotes in implantation hand Invasive lumbar fusion device 1800 is inserted into patient's body during art.First, because wedge-type shape, fusion device 1800 is pushed away in user When entering in the space formed by two endplates, auxiliary user makes fusion device 1800 placed in the middle in the space.Second, due to Invasive lumbar fusion device 1800 is under non-expanded configuration in the height reduced, part (such as top panel 1850 of fusion device 1800 And/or bottom panel 1860) in the surgical procedure by contact plate, so as to hindering the possibility of propulsion of fusion device 1800 to subtract It is small.

In certain embodiments, the conversion of the device never expanded configuration to expanded configuration can be by trailing edge 1808 Front panel 1802 applies force to perform on direction.This can by pull front panel 1802 and meanwhile suppress the device parallel to Any translation (that is, by applying such as reaction force on top plate 1850 and bottom plate 1860) in the plane of endplate is come real It is existing.Both rotatable attachments due to the power on front panel 1802 and top section 1816a and bottom section 1816b, activity Hinge 1810 is pulled towards rear end 1808.This movement increase is formed between top section 1816a and bottom section 1816b Angle, so as to cause the vertical extension of fusion device 1800.

It should be noted that fusion device 1800 can also use other methods to open.For example, can be alternatively towards front end 1806 place power in detour main body 1805, while suppress front panel 1802 or more properly hinges 1810 in equidirectional Upper translation.In another example, can alternatively the side collapsed with side panel in the opposite direction on to side panel apply Power.Therefore, if inwardly internal volume 1890 is collapsed, then can be on the direction away from internal volume 1890 each Apply separated power on side panel.If it is outwardly away from internal volume 1890 to collapse, then can be towards internal volume 1890 Direction on apply separated power on each side panel.In another example, can be applied to the lower surface of top panel Add upward vertical force, and downward vertical force can be applied to the top surface of bottom panel, to start transfer process.To Never during expanded configuration is transformed into expanded configuration, some or all of above method can combine fusion device 100 Together.

Modification, modification and combination

Those skilled in the art, which can be readily apparent that, changes the difference of the implementation described in present disclosure, and In the case where not departing from the spirit or scope of present disclosure, the General Principle limited herein can be applied to other implementations. In addition, any step described herein can perform simultaneously or by from such as order different the step of sequence herein.This Outside, as being understood that, the feature and attribute of specific embodiment disclosed herein can be combined differently to be formed separately Outer embodiment, all of which fall in the range of present disclosure.Therefore, present disclosure is not intended to be limited to realization shown herein Mode, and be intended to reach the consistent of widest range with feature with regard to principle disclosed herein.

Conditional statement used herein, such as especially " can (can) ", " can (could) ", " may (might) ", " can (may) ", " such as " etc., otherwise understood unless otherwise expressly stated or under the background used, otherwise led to Often it is intended to pass on：Some embodiments include and other embodiment does not include some features, key element and/or state.Therefore, this bar Part language is not generally intended to imply：Those features, key element and/or state are all that one or more embodiments are wanted anyway Ask, or that one or more embodiment is inputted or prompt either with or without user all necessarily including any specific for determining Whether include or will perform the logic of these features, key element and/or state in embodiment.

Claims

1. it is a kind of be used to manufacturing be used to be placed between adjacent vertebrae using 3D can print material there are hinges can The method of Invasive lumbar fusion device is extended, this method includes：

The 3D data of the expansible Invasive lumbar fusion device are provided to 3D printer, which includes detour main body, The detour main body has multiple side segments for being rotatably attached by Integral type movable hinge, these Integral type movable hinges by with It is set to during the detour main body never expanded configuration is converted to expanded configuration and bends or deform；And

This multiple side segment of the file printing detour main body are can print using one or more 3D and these Integral type movables are cut with scissors Chain.

2. the method for claim 1, wherein one or more 3D materials are selected from the group being made of the following Select：Thermoplastic, photopolymer, metal dust, eutectic metal, titanium alloy, and combinations thereof.

3. the method for claim 1, wherein one or more 3D materials are selected from the group being made of the following Select：Examples of natural biocompatible materials, synthesising biological compatibility material, biocompatible metal material, adaptive material, 4D are beaten Print material, and combinations thereof.

4. the method for claim 1, wherein one or more 3D materials are selected from the group being made of the following Select：Polyether-ketone (PEK)；Polyetherimide (PEI), such as Ultem；Ultra-high molecular weight polyethylene (UHMPE)；Polyphenylene； Polyether-ether-ketone (PEEK), including memory PEEK materials, such as PEEK Altera；And combinations thereof.

5. the method for claim 1, wherein the Invasive lumbar fusion device includes external coating, which is from by following Selected in the group of item composition：Plasma spray coating, hydroxyapatite coating layer, biological agent, antibiotic, medicine or gene are treated Method, nanometer technology platform, and combinations thereof.

6. the 3D that the method for claim 1, wherein these Integral type movable hinges include relative flexibility can print material Material, and the 3D that these side segments include relative stiffness can print material.

7. the method for claim 1, wherein the 3D of the relative flexibility, which can print material, includes nonmetallic materials, and is somebody's turn to do The 3D of relative stiffness, which can print material, includes metal material.

8. the method for claim 1, wherein the 3D data are the predefined datas of standard fusion device size.

9. the method for claim 1, wherein the 3D data are 3D imaging datas, this method further comprises：Operating The preceding adjacent vertebrae to patient is imaged to generate 3D imaging datas.

10. method as claimed in claim 5, wherein, which is that 3D can print material.

11. the method for claim 1, wherein these hinges include being configured to permit the office of the detour main body Portion is bent or the narrowed portion of the detour main body of deformation and/or to the notch in the detour main body.

12. the method for claim 1, wherein the detour main body includes the near-end that laterally axis is arranged on the contrary And distal end, and the near-end is distally in largest interval with this under the non-expanded configuration, and this is near under the expanded configuration End with this distal end together with closer to the expansible Invasive lumbar fusion device is configured between adjacent vertebrae from the non-expanded configuration water Level land expands to the expanded configuration.

13. the method as described in claim 1, further comprises：Top panel and bottom panel are printed, wherein, the top surface Plate and each free Integral type movable hinge of the bottom panel are rotatably attached on one or more side segments, the expansible vertebra Between fusion device be configured between adjacent vertebrae vertically expand to the expanded configuration from the non-expanded configuration.

, should 14. the method for claim 1, wherein the expansible Invasive lumbar fusion device further comprises variable-volume pouch Variable-volume pouch can be positioned in the internal volume of the Invasive lumbar fusion device.

15. the method for claim 1, wherein the expansible Invasive lumbar fusion device further comprises cable, the expansion is unfolded Cable be connected in the detour main body and be configured for the detour main body applying power so as to make the detour main body from this Non- expanded configuration is converted to the expanded configuration.

16. the method for claim 1, wherein the expansible Invasive lumbar fusion device further comprises expansion instrument, the expansion Instrument be connected in the detour main body and be configured for the detour main body applying power so as to make the detour main body from this Non- expanded configuration is converted to the expanded configuration.

17. the method for claim 1, wherein the expansible Invasive lumbar fusion device is configured to be positioned at two pieces of vertebras Between soleplate and it is further configured to be converted to expanded configuration for never expanded configuration, so as to cause the expansible intervertebral What the size and dimension of fusion device changed and increased the expansible Invasive lumbar fusion device changes internal volume.

18. a kind of be used to can print material manufacture using 3D and have hinges using being used to be placed between adjacent vertebrae The specific expansible Invasive lumbar fusion device of patient method, this method includes：

The adjacent vertebrae of the patient is imaged before operation to generate 3D imaging datas；

The 3D data are supplied to 3D printer；

The expansible Invasive lumbar fusion device of file printing is can print using one or more 3D, which includes detour Main body, the detour main body have the multiple side segments being rotatably attached by Integral type movable hinge, these Integral type movables hinge Chain is configured to bend or deform during making the detour main body never expanded configuration be converted to expanded configuration；And

The expansible Invasive lumbar fusion device is positioned between these adjacent vertebraes in a manner of surgery；And

The expansible Invasive lumbar fusion device is set to expand to the expanded configuration from the non-expanded configuration between these adjacent vertebraes.

19. the method for claim 1, wherein one or more 3D materials are from the group being made of the following Selection：Thermoplastic；Photopolymer；Metal dust；Eutectic metal；Titanium alloy；Examples of natural biocompatible materials；Synthesis Biocompatible materials；Biocompatible metal material；Polyether-ketone (PEK)；Polyetherimide (PEI), such as Ultem；Superelevation Molecular weight polyethylene (UHMPE)；Polyphenylene；Polyether-ether-ketone (PEEK), including memory PEEK materials, such as PEEK Altera；And combinations thereof.

20. it is a kind of be used to be unfolded to be used to be placed between adjacent vertebrae using 3D can print material there are hinges can The system of Invasive lumbar fusion device is extended, which includes：

Expansible Invasive lumbar fusion device, the expansible Invasive lumbar fusion device can print material by one or more 3D and be made, this is expansible Invasive lumbar fusion device is configured to never expanded configuration and is converted to expanded configuration, has proximally and distally, the expansible intervertebral fusion Device includes detour main body, which has the multiple side segments being rotatably attached by Integral type movable hinge, these are whole Body formula hinges are configured to bend during making the detour main body be converted to the expanded configuration from the non-expanded configuration Or deformation；And

Variable-volume pouch, the variable-volume pouch can be positioned in the Invasive lumbar fusion device, which is configured to For making the expansible Invasive lumbar fusion device be moved to the expanded configuration from the non-expanded configuration.