CN101528110A - Percutaneous access and visualization of the spine - Google Patents

Percutaneous access and visualization of the spine Download PDF

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Publication number
CN101528110A
CN101528110A CN200680054506.4A CN200680054506A CN101528110A CN 101528110 A CN101528110 A CN 101528110A CN 200680054506 A CN200680054506 A CN 200680054506A CN 101528110 A CN101528110 A CN 101528110A
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China
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silk thread
visualizer
strut
tissue
distal part
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CN200680054506.4A
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D·H·基姆
S·金
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Leland Stanford Junior University
Spine View Inc
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Leland Stanford Junior University
Spine View Inc
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Priority claimed from PCT/US2006/008758 external-priority patent/WO2007106081A2/en
Publication of CN101528110A publication Critical patent/CN101528110A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The present invention discloses devices, systems and methods are provided for the percutaneous access and visualization of the spine for the purposes of diagnosing and/or treating a target area of the spine or the surrounding tissue.

Description

The percutaneous of spinal column enters and observes
Technical field
The present invention relates to percutaneous and enter the part of (percutaneous access) and observation spinal column to be used to diagnose and/or treat the target position district or the surrounding tissue of spinal column.
Background technology
Spinal column is formed by a plurality of vertebral bodys 20 that separated by intervertebral disc 10, and intervertebral disc 10 is main as the mechanical damping structure between the vertebra, allows the controlled motion (flexing, stretching, extension, lateral thrust and axially rotation) in vertebral levels simultaneously.Figure 1A is the back side view of two vertebral bodys 20 separating by intervertebral disc 10.Intervertebral disc 10 is the cushion pads with top and bottom end plate 12, and above-mentioned end plate 12 is in abutting connection with the bone surface of each adjacent vertebral 20.From this rear portion advantage point, owing to the layout of intervertebral disc 10 with respect to vertebral structure such as spinous process 60, the next zygapophysial joints (inferior facet joint) 64, upper zygapophysial joints 66 and pedicle of vertebral arch (pedicle) 67, it is very difficult to enter intervertebral disc 10.
Figure 1B passes the crown position (coronal view) that healthy disc 10 and surrounding structure are got.Each end plate 12 (seeing Figure 1A) comprises thin cartilage, and described cartilage covers the hard cortical bone of skim, and this cortical bone is attached on the spongy multivessel reticulated bone of vertebral body 20.Intervertebral disc 10 comprises vertebral pulp 30 (" nuclear ")---a kind of gelling material that is used as the buffer structure of compression stress.Encloses core 30 be fibrous ring 40 (" ring ").Ring 40 comprises the fibrous layer or the thin slice of a plurality of concentric collagen fiber, is called flaggy (lamellae).When spinal column by compression and make in succession vertebra 20 combine, resist reversing of spinal column and when helping nuclear to absorb compression stress, ring 40 restriction nuclears 30 expand.The nerve fiber 80 of fibrous ring 40 adjacent rings, spinal nerves root 82, epidural space 65, spinal dura mater 70, spinal pia mater or canalis spinalis 72 and epidural venous plexus 81.
Fig. 1 C illustrates the exemplary injury 50 of intervertebral disc 10.In this sketch map, damage 50 is intervertebral disc 52 that give prominence to or prolapsus.This situation may be the result of the serious or unexpected wound of spinal column, perhaps is that non-traumatosis is managed as degenerative ridge disease, may cause protuberance or fracture in one or more intervertebral disc.Because degeneration or damage are endorsed the dehydration that can become, thereby have been become less liquid and mucilage.Endorse with outside protuberance, cause that simultaneously the mechanical stiffness of spinal motion segment reduces, this may cause instability.
Ring 40 is the thinnest at rear side along the general direction of spinous process 60, therefore examines 30 and upward gives prominence to over there usually.Damage is normally on the proceeds posterolateral rather than directly carrying out in the wings, because the vertical central authorities (sagittal midline) of the vertical ligament in rear at the rear of ring have strengthened fibrous ring.Term " rear " and " in the wings " meaning are meant the cardinal principle rear of intervertebral disc and the orientation 43 of proceeds posterolateral, distinguish with the orientation, the place ahead (substantially in zone 41) with intervertebral disc.
As shown in Figure 1B, the orientation, rear of fibrous ring 40 be subjected to pain/Sensory nerve fibre 80, veutro and/or dorsal part nerve root 82 and other delicate tissue (delicate tissue)---include but not limited to spinal dura mater 70---domination.Like this, the posterior injury of intervertebral disc often has influence on wherein one or more of these nerves.The pressure that causes on these nerves usually causes lower limb (lowerextremities), upper limb or neck area pain, weakness and/or numb.In addition, in case injured, just limited the healing ability that encircles.Usually, healing takes place along with the growth of thin fibrous film in skin.Yet ring will never be got back to its green strength.In many cases, ring will never be closed, subjects to again outstanding or nuclear leakage especially thereby become.
Except traditional lie up, the physiotherapy, adjustment physical exertion kimonos analgesic, thereby increasing treatment attempts to repair injured intervertebral disc to avoid the injured intervertebral disc of surgical resection.Be included in the open surgery method of utilizing muscle excision or percutaneous process under the situation of not observing is used to enter and penetrate intervertebral disc 10 in the therapeutic device and the technology of interior many routines under fluoroscopic guidance a part.
A kind of such treatment is the intervertebral disc decompression, comprises excision or reduction at least a portion nuclear, thereby reduces and reduce the pressure on ring and the adjacent nerve.Worked out the aggressive that some technology and apparatus further alleviate this treatment.Once this technology is automatic percutaneous lumbar diskectomy (APLD), and it is used endoscope and helps observe, so that cutting nuclear tissue and vacuum are removed loose jelly.Yet, under the APLD situation, the surgeon can not observe nerve root itself (because character of the technology of beginning), and therefore can not determine whether the nuclear fragmentation of excision is the problem source, can not locate and excise any material that has surpassed disc range and entered canalis spinalis.Another kind of technology to the intervertebral disc decompression is micro-excision, and as what its name hinted, micro-excision comprises the use microscope, and described microscope has amplified operative region and good illumination is provided.Yet the shortcoming of this technology is near pathology such as the side latent narrow (recessedstenosis) can not discerning owing to the limited visual field.
Except the excision disc material, other treatment comprises the enhancing intervertebral disc, and implantation instrument in described intervertebral disc is so that treat, postpone or prevent disc degeneration.Enhancing relates to enhancing of (1) ring and the enhancing of (2) nuclear, and above-mentioned ring strengthens ring that comprises the outstanding intervertebral disc of reparation, supporting damage and/or the ring that sealing is torn, and in above-mentioned nuclear strengthens other material is added in the nuclear.
Usually, these conventional systems rely on visual observation to come near intervertebral disc, and therefore lack real-time, airborne (on-board) observation ability of any kind of.Even the application visualizer, the ability of the object outside its directapath of its observation also is restricted, even and under such situation, also without any depth preception to distinguish local pathology.Although can before using visualizer, form the space earlier,, form described space and but can only or must carry out blindly with external guidance if percutaneous carries out.
Be used to implement the effective instrument of above-mentioned operation and technology except lacking, as what seen from the rear advantage point of Figure 1A, because it is with respect to vertebral structure such as spinous process 60, the next zygapophysial joints 64, the layout of upper zygapophysial joints 66 and pedicle of vertebral arch 67 makes and enters intervertebral disc 10 difficulty more.Although when bony structures can be passed through, have other anatomical structures (as fat, conjunctive tissue, lymph, tremulous pulse, vein, blood and spinal nerves root) along access path and/or in the epidural space, they have limited, and the insertion epidural spatially anyly enters, observes, insertion, motion and the observation ability of diagnosis or therapy equipment.In addition, promptly enable to arrive the target position space, also still have the danger that damages nerve root, dural sac or other organizational structure all the time.
In a word, the many conventional process (even be considered to less invasive those) that are used for the treatment of spinal column can not provide AT direct observation.As a result, the working space that is used to observe is restricted, and can not observe near target site place or its, diagnose and treat local pathology, and have the danger of soft tissue injury.
Therefore, need to form to no wound the percutaneous method and apparatus of working space in tissue, described method and apparatus can provide the percutaneous direct observation and can make therapeutic scheme the best.Especially, required is the technology and the system of aggressive minimum, and they provide direct observation and diagnosis or repair in the spinal column or the ability of the target site at spinal column place, and makes simultaneously the damage minimum of anatomical structure and tissue on every side.In addition, also need a kind of method and apparatus, described method and apparatus makes the doctor can enter patient's epidural space, the zone in the cleaning space effectively, so that strengthen observation property and utilize observation ability to diagnose and treat spinal injury.
Summary of the invention
The invention provides the device, the system and method that are used to enter and observe intravital target site.They are very limited with observation space for entering, enter difficulty and exist and largely make the spine regions of patient's pain or injured danger particularly useful.Therefore, described device can be used for any process relevant with spinal column with system, includes but not limited to repair outstanding intervertebral disc, repairs the ring torn, gives pressures of examining and making cuts, implants ring or examine intensifier, implant electrode etc.
One aspect of the present invention is that the AT space of contiguous target site and/or contiguous visualizer far-end forms and/or is used for forming the path or distance is come for the user provides the perspective visual field between visualizer and target site, so that assess local pathology best and be provided for implementing treating or the working space of diagnostic task or process.In use, the various embodiment of subject apparatus and system use mechanism and parts manipulation of tissue on side direction, distally and/or the nearside of the far-end of device or system.Tissue manipulation is included in structural various effect as used herein, includes but not limited to move, promotes, cuts open, compresses, displacement etc.These operate under the situation of the present invention and finish by various mechanisms.In certain embodiments, use mechanical component such as framework, strut, silk thread (wire), hook spare, ring etc., and in further embodiments, use expandable material such as inflatable air bag and with gel-filled barrier film.
New feature, parts and the device of realizing these inventive aspects usually but not necessarily be combined into a part that enters with induction system or device, described system or device can also comprise known feature, parts and device, comprising but be not limited to sleeve pipe, the trocar, conduit, seal wire, endoscope and be used to cut open, remove, cut, melt (ablate), puncture, sew up, nail is solid, cut short (clip), flushing, suction, injectable drug and stem cell etc., apply energy, the power tool of detection, placement electrode etc.
Also disclose and be used to enter and observe intravital target site, be used for manipulation of tissue and be used to use the method for device of the present invention and system.
For a person skilled in the art, these and other feature of the present invention, purpose and advantage will become apparent during the details of the present invention of explanation below reading more fully.
Description of drawings
When reading following detailed description in conjunction with the accompanying drawings, can understand the present invention best.Should emphasize that by convention, each feature not to scale (NTS) of accompanying drawing illustrates.On the contrary, for clarity sake, the size of each feature is at random enlarged or is dwindled.In order to help to understand, when feasible () utilizes identical label represent the like that has in the accompanying drawing.Accompanying drawing comprises:
Figure 1A is two basivertebral back side view; Figure 1B is the healthy disc and the crown position of anatomy of spine on every side; Fig. 1 C is the crown position of the intervertebral disc given prominence to;
Fig. 2 A-2D shows the different views of the embodiment of access to plant of the present invention, and wherein, described access to plant uses with preformed wire frame formula operating means of the present invention, and operating means is so that expansion and unfolded state illustrate;
Fig. 3 A and 3B are to use the longitudinal sectional view of the access to plant of the operating means that includes the combination of preform wire frame/air bag of the present invention, and wherein operating means is to launch and unfolded state illustrates;
Fig. 4 A and 4B are to use the longitudinal sectional view of access to plant of the silk thread formula operating means of free form of the present invention, and wherein operating means is to launch and unfolded state illustrates;
Fig. 5 A-5C shows the different views of the access to plant that uses the silk thread operating means with preformed spiral or coiling (coil) configuration, and wherein operating means is so that expansion and unfolded state illustrate;
Fig. 6 A and 6B show not expansion and the unfolded state that becomes whole another coiling formula manipulation device of the present invention with access to plant of the present invention respectively;
Fig. 7 A and 7B show not expansion and the unfolded state that becomes whole another ring type manipulation device of the present invention with access to plant of the present invention respectively;
What Fig. 8 A and 8B showed method of the present invention respectively becomes the not expansion and the unfolded state of whole balloon-type tissue manipulation device with access to plant; Fig. 8 C, 8D and 8E show the side view and the end-view of described operating means; Fig. 8 F shows the side view of the varied slightly of operating means;
Fig. 9 A-9D shows other gasbag-type of the present invention and enters modification with operating means; Fig. 9 E shows a kind of occupation mode of air bag operating means of the present invention;
Figure 10 A-10D shows the operating means based on gel of the present invention and is in the different phase of launching and using;
Figure 11 A-11C shows the different embodiment of proximal tissue shift unit of the present invention; With
The proximal tissue shift unit that Figure 12 A-12C shows the manipulation device of using Fig. 8 A-8E and Figure 11 A is implemented the different views of the embodiment of the method for the treatment of in spine regions by lateral approach in the wings.
The specific embodiment
Device of the present invention and apparatus are primarily aimed at and enter and observe the intravital target site of body, special very limited for entering with observation space, enter difficulty and exist and largely make the spine regions of patient's pain or traumatogenic danger useful.In conjunction with spinal column, the explanation of the exemplary application under intervertebral disc situation the present invention more specifically.Adaptable other exemplary application of subject apparatus and uses thereof includes but not limited to the application of heart, nerve, blood vessel, intestinal, reproductive system and others, wherein, the surgery target site relates to the organ and the soft tissue structure of the fragility that enters difficult especially or trouble.
Subject apparatus and apparatus can with other known devices and system be used in combination or as the parts of described device and system.For example, the U.S. Patent application No.11/078 that on March 11st, 2005 submitted to, agent's identifier of submitting on February 23rd, 691 and 2006 is the U.S. Patent application of No.SPVW-001CIP, and---the two title is " PercutaneousEndoscopic Access Tools for the Spinal Epidural Space and RelatedMethods of Treatment " and all is included in herein as a reference---discloses and is used to enter, observe, diagnosis and/or treatment intervertebral disc interior or the target site at intervertebral disc place or the different apparatuses of interior other tissue site of body, described apparatus can integrally or partly be used with the present invention.
An importance of the present invention is that path or the no wound of the distance ground between vicinity target site and/or contiguous scopic far-end and/or visualizer and the target site forms the space, so that have an X-rayed the visual field to evaluate local pathology best and the working space of implementing treatment or diagnostic work or process is provided for user provides.New feature, parts and the device of realizing these invention aspects usually but not necessarily be integrated into a part that enters with induction system or device, described system or device can also comprise known feature, parts and device, comprising but be not limited to sleeve pipe, the trocar, conduit, seal wire, endoscope and be used to cut, pierce through, sew up, follow closely consolidate, cut short, inject, the power tool of removal etc.Therefore, term used herein " access to plant ", " entering system ", " conveyer device ", " induction system " etc. can comprise feature, parts and the device of one or more known parts commonly used in the invention field and device and theme invention.
The following describes different exemplary embodiment of the present invention.Without limitation with reference to these embodiment.They are provided as and illustrate applicable widely aspect of the present invention.Under situation without departing from the spirit and scope of the present invention, can make various changes and replaceable equivalent to described invention.In addition, can make multiple modification so that concrete condition, material, material composition, process, process stage or step are adapted to purpose of the present invention, spirit or scope.All such modifications all should be considered in the scope of the claim advocated at this paper.
Fig. 2 A-2D shows an embodiment of access to plant 100 of the present invention.Access to plant 100 is included in a pair of operation path 102,104 of the far-end opening of device 100, wherein, passage, is the observation panels that are used to carry visualizer, imaging and/or illuminace component 106 such as path 10 2, so that the direct observation ability to be provided.In an alternative embodiment, to hold a plurality of parts different with single observation panel, and each parts can have and is used to throw light on, observe, analyze the dedicated port of anatomical environment on every side.Although observation panel 102 is towards the distally or eyes front, (not shown) can be used one or more lateral port on the other hand.Passing operation path can also be provided with and organize classified sensor or their function equivalent device.In addition, device 100 can turn to, so that further increase its directivity and range of observation.
Tissue manipulation tool of the present invention 114 with proximal shaft 112 is arranged in another operation path 104 of device 100, and can pass described operation path 104 and carry.Instrument 114 has an open frame structure 108, and this frame structure 108 has the strut that forms the flower base of a fruit or cochlear, and wherein concave side is towards interior that is towards visualizer 106.The shape of framework 108 (annular, shaped form, spiral type etc.), configuration of surface and general outline are chosen to make impacts minimum when framework/strut contacts with anatomical structure, above-mentioned anatomical structure comprises nerve, muscle and spinal dura mater except that other.Wire frame/strut is made by the adaptive material of flexibility such as NITINOL (Nitinol) or non-rigid polymer, thereby framework/strut can be compressed into the shape of dwindling, carry (seeing Fig. 2 C) in the path 10 4 to be used to passing path 10 4 or to be hidden in, and when coming out from path 10 4 or advancing, be returned to expansible configuration (seeing Fig. 2 D) then in the distally.In addition, framework 108 can be configured to expansion in advance or be launched into any suitable configuration.For example, shown in the convex side of framework 108 when being in complete deployed condition, on the side direction of the wall of device 100, extend a little, make any obstacle minimum in the visualizer sight line simultaneously.This extend laterally help adjoin " pusher " or opposing framework be provided when connecing anatomical structure maximum working space is provided to intrinsic deflection with near visualizer 106.
When being in complete deployed condition following time, framing component 108 has limit an arcual transverse section (illustrating best) in Fig. 2 B of the end-view of generator, arc and span that described arc is basically parallel to the excircle of apparatus main body 100 are not more than about 270 °, more typically from about 110 ° to less than about 180 °.Like this, framework 108 can have radial dimension in the about 10mm scope of about 4mm-(from its central axis to its excircle) when expanding, the maximum linear extending range is apart from the about 15mm of the far-end of access to plant, but can be shorter, wideer and longer according to current application.Although favourable with comparing of can accomplishing than small frame bigger arcuate span when moving the organizing of big quality or volume, bigger framework may need more strut and therefore hinder observation by visualizer 106.Device 114 can be configured such that frame structure 108 can rotate or rotate (as shown in Fig. 2 B) path 10 4 in, thereby the dimensional requirement (with required strut number) that has reduced framework also can allow wideer range of observation.In addition or selectively, the mechanically deflection or turn to of axle 112 and/or instrument 114 forms with further enhancing observation and space.
Alternatively, can on all or part of open spaces between the strut, be extended with Web materials 110, so as to provide other surface area be used to be shifted, the tissue in promotion or mobile observation instrument 106 distally.Preferably, Web materials 110 is transparent so that do not hinder observation.Suitable one-tenth net materials includes but not limited to polyurethane, silicones and polyester.
Device 100 can have one or more other operation paths to be used to carry any other diagnosis or treatment tool or therapeutic agent (agent), and they can separate with operation tool 114 or collaborative the use.Other instrument of device 100 conveyings or the example of therapeutic agent be can pass and pick off, flushing machine, aspirating mechanism, treatment (energy) conveying (such as RF energy, ablation energy etc.), drug conveying, implant conveying, cutting mechanism etc. included but not limited to.
Fig. 3 A and 3B show another embodiment of the manipulation device of using with access to plant 100 and visualizer 106.This manipulation device comprises an inflatable or expandable air bag 120, and described air bag 120 is fixed on the wire frame 118, and is communicated with an inflation/expansion (gas or liquid) chamber 122.As about the described operating means of Fig. 2 A-2D, wire frame 118 is soft and compressible, and can be configured in advance can take any desirable shape, profile and profile when being in swelling state.Therefore, partly relevant with the compliance of bag material, when unrestricted and when being inflated, air bag 120 is taked the general shape of wire frame 118, as shown in Fig. 3 B.In stowed position, as shown in Figure 3A, air bag keeps venting till wire frame 118 is launched.Bag material is preferably transparent, to allow outside its scope of observation.
Although above-mentioned manipulation device provides a kind of preformed compressible/expandable frame, framework does not need preformed shape.For example, the operating means 136 of Fig. 4 A and 4B comprises that one can pass the silk thread of the free form of operation path 104 conveyings.One end 134 of silk thread 136 anchors to access to plant 100 at anchor site 138 places, for example in chamber 104 or on the outer surface of device.From anchored end 134, silk thread 136 distally ground extends, and under deployed condition not as Fig. 4 A be shown in crooked or fold apart from anchor site 138 1 apart from 136a place self so that do not extend the far-end of device 100.This configuration provides a low profile front end that flushes when the beginning percutaneous inserts device 100.Although anchor site 138 can be in any position along the length in access to plant 100 or chamber 104, the far-end of the approaching more device of anchor point, silk thread 136 are perhaps short more.Make the total length minimum of silk thread reduce the danger of being entangled with or blocking up.
When not launching, remaining wire length is similar in path 10 4 extends, and comes out in the proximal end of device 100, and at described near-end, the free end (not shown) of silk thread can be used for operation.More specifically, free end can be operable to and optionally make silk thread 136 pass chamber 104 to advance and withdraw, as shown in Fig. 4 B.When launching operating means, the length of silk thread 136 advances out from chamber 104, thereby forms the annular frame of a flexibility, and the size of described annular frame can easily be regulated by selected advancing/retractile action.
The rotation orientation of access to plant 100 also can be conditioned, so that visualizer 106 is positioned to be positioned at more or less " the cover umbrella " that is limited by unfolded silk thread 136.Optionally operate the working space that silk thread and access to plant main body enable to form sufficient size, visualizer 106 and/or other power tool (not shown) can advance in the above-mentioned working space, so that implement current diagnosis or treatment task.For example, silk thread 136 can be on distal direction increment type expand, this is formed for conveying space that device 100 is entered, the further manipulation of tissue of information evaluation that provides with visualizer 106 and install 100 and/or the progressive degree of other apparatus.Repeating various operations, visual assessment and instrument in case of necessity advances, so that enter predetermined target site, near target site, form operation and observation space and assess local pathology, to determine concrete mechanism to be taked, that is, pending treatment type (such as excision, ring increase, energy to be applied etc.), the type of diagnosis to be performed etc.
Fig. 5 A-5C shows the operating means 140 of another kind with the wire type of access to plant 100 uses.Although silk thread 140 has preformed shape, the unfixing or grappling in its two ends.Similar with the operating means of any wire type disclosed herein, make with superelastic metal alloy or flexible polymer, silk thread 140 has the preformed spiral or the coiling configuration that can expand into when it launches, as shown in Fig. 5 B and 5C, and when being limited in mouthfuls 104, stretch basically as shown in Fig. 5 A.Resulting coiling configuration have a winding density/gap with enough strong and have flexible so that there is formation space in tissue, wound ground.Coil diameter is enough big, promptly greater than the diameter of visualizer 106, and usually greater than the diameter of access to plant 100, so that allow fully to observe and/or enter the zone in its far-end 142 distally.Expand or during deployed condition when being in, coil diameter can be constant or along the length variations of silk thread.In a kind of modification, as shown in the figure, expansible spiral has the diameter that is tapered or reduces to the near-end (not shown) from far-end 142.
Although above-mentioned manipulation device is the parts that are relatively independent of the access to plant that is used for carrying them, in some invention modification, operating means can structurally become integral body with the access to plant main body.The embodiment of this monoblock type apparatus is described now.
Under the situation of the embodiment shown in Fig. 6 A/6B and the 7A/7B, but carry the tissue manipulation member of an expanded radially in the distal part of the axle of access to plant at least.Under not unfolded state, shown in Fig. 6 A and 7A, control member flushes with the outer surface of access to plant.Under deployed condition, shown in Fig. 6 B and 7B, control member radially stretches from access to plant, moves into into the tissue displacement of 360 ° of the far-ends of device or cuts open so that make.
The access to plant 150 of Fig. 6 A and 6B provides tissue manipulation member 156, it comprise around the distal basin of axle 152 around or the silk thread or the band that twine.Access to plant 150 can provide any amount of channel lumens 160, to be used to carry visualizer 158 and any other treatment or diagnostic tool or therapeutic agent.Band 156 has tightly a plurality of windings or the band section 154 of twining around axle 152, so that be provided at finished product that member 156 flushes along the outer surface of axle before launching so that pass tissue conveying.Band 156 can stretch (promptly reeling) any suitable distance along the axle nearside, but has only the utmost point distal part of axle to be capped usually.The expanded radially of band section 156 is by loosening in the clamping of the proximal end of band or realizing by heating under situation about making with temperature-sensitive superelastic material.Like this, band section around and be orthogonal to the distal part of (inclination is arranged when wishing slightly) axle 152 substantially.The far-end of axle 152 is fixed or anchored to the utmost point far-end 162 of band 156, so that keep the radially control of degrees of expansion.
The access to plant 170 of Fig. 7 A and 7B provides the tissue manipulation member 176 that is positioned at the distally, and it comprises a plurality of axially extended band sections, strut or stay 174, forms by the slit in the tubular material that forms control member 176 178.Strut 174 is parallel to the longitudinal axis of access to plant 170 and places.As in any theme access to plant, assembly axis 172 can provide any amount of channel lumens 184, to be used to carry visualizer 182 and any other treatment or diagnostic tool or therapeutic agent.Member 176 can extend any suitable distance along axle in nearside ground, but has only the utmost point distal part of axle 172 to be capped usually.The far-end of axle 172 is fixed or anchored to the far-end 180 of control member 176 or its each band section 174.By being moved relative to each other, control member 176 and axle 172 realize being with the expanded radially of section 174.This can be by only at shifting axle on the proximal direction 172, mobile member 176 or the two is moved in the opposite direction realize on distal direction only.Selectively, if make, then the band section is expanded by heating with temperature-sensitive superelastic material.Stay is expanded diametrically and on far-end, and still be parallel to access to plant 170, as shown in Fig. 7 B.The band section of complete expansion forms ring separately, and the set of these rings is configured as the annular shape with center channel, and visualizer 182 has the clog-free visual field by described center channel.Therefore, when making soft tissue leave axle 172 far-end to move, promote or cut open, form the path that ground, distally extends, so that working space and the fluoroscopic observation by visualizer 182 are provided.
Fig. 8 A-8F shows another monoblock type of the present invention and enters system 190, and it uses balloon-type tissue manipulation device 194.System 190 comprises passes integral type visualizer or the photographing unit 196 that main shaft 192 extends.Manipulation balloon 194 be combined in the inflation/expansion mechanism (not shown) fluid of axle in 192 and be communicated with.Air bag 194 has a loop configurations, and described loop configurations is fixed around the far-end of axle 192, so that the operation via alignment of its centre bore or opening 198 and axle 192.Shown in the side view of the amplification of Fig. 8 C and 8D and the end-view, when air bag 194 inflations, the sight line of visualizer 196 keeps opening wide and is accessible as best.According to the compliance of used bag material, the exterior contour of air bag can change.In addition, single air bag can be made by a plurality of parts with different compliances.Have at material under the situation of big compliance, inflatable air bag has and the air bag 194 more similar profiles shown in Fig. 8 C.Under the situation of the material of less compliance, air bag has and the air bag 200 more similar profiles shown in Fig. 8 F.Which kind of configuration no matter, air bag be moving tissue and go out an operation passage/space clearly all, but the strut of the mechanical swelling of the tissue manipulation member of its mode and Fig. 7 A and 7B is similar.
Fig. 9 A-9E shows the modification of other balloon-type tissue manipulation/access to plant.The apparatus 230 of Fig. 9 A is endoscopies, and it has a chamber/inflation inlet, to be used to carrying visualizer 234 and the control member 236 that comprises transparent gasbag is expanded.Air bag 236 is mounted to the distal openings that covers chamber 232, and therefore can be at the far-end of internal admission and encirclement visualizer 234.Airbag inflation is many more, then visualizer 234 can be in tissue distally ground extend far more, and needn't make spools 232 to be advanced further in the body.Under this configuration situation, visualizer will never be exposed to in-vivo element, unless be hopeful (this will illustrate in greater detail about Fig. 9 E below) in addition.
The apparatus 240 of Fig. 9 B comprises dual lumen shaft 242.Except being used to carry visualizer 238 and the delivery of scope/balloon inflation lumen 244 to the double duty of transparent gasbag inflation, axle 242 comprises at least one second operation path 246, to be used to carry other treatment and/or diagnostic tool and therapeutic agent.In use, visualizer 238 is preferred near expansible air bag maintenance, so that accurate only cutting open carried out with air bag.When cutting open when finishing and forming enough operations/observation space, when wishing, air bag 248 can be removed.However, axle 242 can axially rotate when needed, to regulate the position of tissue manipulation member 248 and operation path 242.
The apparatus 250 of Fig. 9 C has structure and similar as mentioned above dual lumen shaft 252; Yet balloon manipulation member 257 is extended into and covers the two opening of passage 256,258.Like this, by air bag 257 form bigger, more at the working space of centralized positioning.Compare bigger different being with foregoing access to plant, manipulate when middle, pass directly contact tissue of instrument that operation path 252 carries and therapeutic agent when air bag 257 is in.Therefore, the feature of this embodiment comprises the ability that makes air bag 257 break or break.This normally makes incremental displacement of tissue and visualizer 254 is carried out during at the target site of arrive being scheduled to after advancing by air bag 257.After the local pathology of having assessed the target site place, when be sure oing to treat, air bag 257 is broken, so that the direct assessment to target site to be provided.Can be by using visualizer 254, using and pass therapeutic device that operation path 252 carries or by air bag 257 excessive expansions/inflation realization is broken.The example of the fracture mechanism of instrument 270 forms has been shown in Fig. 9 E, and this instrument 270 is used as the inflatable chamber of air bag 272, and can be used for carrying other instrument.Instrument 270 has a sharper distal tip 274, so that puncture balloon 272 easily.
Although still available visualizer is observed after destroying air bag, under the situation of can " blindly " to the treatment of target site carrying out, can not need visualizer.For example, be under the situation of delivering therapeutic agents in target, expansion fluid can be a therapeutic agent itself, at this moment, therapeutic agent both had been used to make airbag inflation to form working space, be used for then again making the air bag excessive expansion so that it breaks, thereby therapeutic agent was released at the target site place.
Fig. 9 D shows the another modification of the access to plant 260 with integrated balloon-type manipulation member 266.Axle 262 provides the single chamber that is used to admit visualizer 264 and makes air bag 266 expansion/inflation; Yet visualizer 264 can not advance to outside the distal tip of axle 262 here.On the contrary, transparent tip 268 is set above axocoel, it comprises side mouth 265, and air bag 266 passes described side mouth 265 and expands.Tip 268 can be with most advanced and sophisticated and sharp, to work to be similar to the trocar when being formed for making axle 262 progressive paths/working space.Other instrument that tip 268 can also be used to making air bag 266 to break and need directly contact with target site to be used to carry.
Figure 10 A-10D shows another access to plant 210 of the present invention, and it has utilized a kind of transparent gel-like material 214, and this gel-like material keeps to be used for tissue manipulation by transparent submissive barrier film 218.Gel and barrier film the two all respectively by biocompatible materials such as hydrogel and polyurethane manufacturing.Originally gel 214 is contained in the distal part in the chamber that is used for carrying visualizer 216.In other modification, can use the pusher mechanism (not shown) with gel-filled intracavity so that ground, gel rubber material distally advances; In this case, can use one or more being arranged for to carry other operation path 212 of diagnosis and/or therapeutic device or therapeutic agent to carry visualizer.Under the situation of whichever embodiment, can pad or other sealing member (not shown) be set at the gel intracavity and reflux from the near-end in chamber to prevent gel.In barrier film 218 sealing with cover under the situation of distal openings in chamber, gel 214 remains in the boundary in chamber, shown in Figure 10 A.
When delivering into device 210, the far-end of device be positioned to apart from tissue target site 220 about 2mm in about 10mm scope than short distance the time, advance to visualizer or propeller 216 distally, thereby gel 214 released from the chamber.Barrier film 218 is also enough soft and durable, so that stretch to hold the gel of extruding, as shown in Figure 10 B at far-end.Along with visualizer 216 advances, gel continues to extrude from device, and barrier film continues to stretch to hold the gel volume of extruding, and connects tissue 220 up to adjoining with gel-filled barrier film, as shown in Figure 10 C.Because the resistance of 220 pairs of barrier films 218 of organizational structure, gel 214 lateral expansions of holding back also make fluid and other structure displacement, and to limit an observation space that enlarges, the far-end of visualizer 216 may be advanced in the described observation space, as shown in Figure 10 D.Formed observation space provides the required perspectivity of local pathology that is used for fully assessment and analyzes contiguous target site 220 for the user.When other apparatus need directly contact with tissue, the instrument that can be passed operation path 212 conveyings with gel-filled barrier film itself promoted or is operable to leave the path, and therefore continues to be provided for the transparent visual field of visualizer 216.When process is finished, be retracted in the nearside of visualizer 216 and form negative pressure on the gel, and it is sucked back in the scope lumen.Selectively, barrier film can make gel overflow, thereby observation space is transformed into working space thus otherwise by using power tool to pierce through.Under the situation of a kind of modification in back, gel can comprise that antibiotic or therapeutic agent are to help the target site healing.
Except distally ground with laterally form the space at the guiding or the tip far away of access to plant, conveyer device, visualizer or other apparatus, the present invention also provides and has been used for nearside ground in the formation space of device end of guiding/far.Be used for the various tissue manipulation mechanism that proximal space forms and parts can use separately or be used in combination with being used for those mechanisms and parts that side direction and distal space form, perhaps otherwise become integral body with them.Figure 11 A-11C shows to be attached to and enters/embodiment of this class proximal tissue manipulation machinery in carrier pipe or the sleeve pipe, they can comprise a plurality of passages that are used to carry visualizer and treatment and diagnostor and therapeutic agent, perhaps can otherwise be used as these parts or interior pipe or sleeve pipe and can pass the overcoat of wherein carrying.For arbitrary embodiment, when using in vivo, proximal tissue manipulation members can only be used for being shifted or cut tissue open and/or can be used for forming traction to access to plant.
The access to plant 220 of Figure 11 A is used one, two or more plurality of wire members or hook spare 224, described hook spare can be laterally from the remote extension of access to plant 220.The knob 222 that expansion can be for example be positioned at the access to plant proximal end by rotation is activated, and described knob 222 is attached to and pushes away/draw silk thread or the analog that is contained in the access to plant.When launching, hook spare is driven in the contiguous tissue.Hook spare can be used to nearside ground pulling tissue and leave the far-end of access to plant 220 then, so that can observe better or enter better with power tool with visualizer.
The proximal tissue manipulation parts of the access to plant 230 of Figure 11 B are inflatable/expandable air bags 234, and described air bag 234 is positioned on the nearside a little of far-end of device and can expands on its side direction.Air bag 234 becomes fluid to be communicated with the inflation/expansion chamber of installing in 230.Equally, the access to plant 240 of Figure 11 C is used a plurality of air bags 244 so that in far-end 240 nearside ground manipulation of tissue.The gasbag-type embodiment can use similarly with above-mentioned hook-type embodiment, and reason is that the nearside translation of access to plant, i.e. pulling can cause and further cut and/or provide traction open.
Referring now to Figure 12 A-12C and from rear or proceeds posterolateral near the situation of intervertebral disc under explanation illustrative methods of the present invention.Access to plant 250 comprises sleeve pipe 252, and the trocar 254 of band clear tip passes above-mentioned sleeve pipe 252 and carries, and is used for forming the percutaneous import of passing the patient back, as shown in Figure 12 A.Can use cryptoscope to help realize this step.One very the visualizer 256 of minor diameter (external diameter is less than about 1mm) pass sleeve pipe 252 and carry.When access to plant pierces through skin, fat and muscle and when it finally enters vertebral column canal space 270, the clear tip 254 of the trocar allows to observe, and as shown in Figure 12B, visualizer 256 has been guaranteed accurate layout therein.This some place in process can take out the trocar from sleeve pipe.Visualizer can be removed equally, but it can be retained in the sleeve pipe, if help remaining process and can otherwise not hinder the operation path that is used for by other apparatus to use.If sleeve pipe 252 is configured for tissue manipulation, then the duration of process, be retained in the back.Selectively, sleeve pipe 252 is if conventional sleeve pipe then can only be used for realizing entering in the target site near zone and being used for carrying independent space to form device or sleeve pipe, example device 260 as shown in Figure 12B.
Device 260 (or installing 250) comprise a delivery of scope passage (and other operation path), and be equipped with distal/lateral and proximal space form mechanism the two, one of them is used although may have only the two.In order to realize traction and/or to form initial space, just in time on the nearside of device 260 far-ends, proximal tissue manipulation mechanism 262 (taking the form of the hook spare formula device of Figure 11 A here) is deployed in the tissue.By promoting actuation element 266 hook spare 262 is launched, described actuation element 266 is installed to around the knob 264 of sleeve pipe 260 with being positioned at nearside.By turning knob 264 working tension on hook spare 262, cause them to be pulled rearward at the tissue that engages.Like this, sleeve pipe 260 is stabilized, the tissue of contiguous boot proximal end is unloaded a little, so that help by launching the other tissue manipulation that distal/lateral tissue manipulation mechanism 272 (taking the form of the gasbag-type device of Fig. 8 A-8E here) provide, as shown in Figure 12 C.Inflatable air bag 272 makes fatty tissue, spinal dura mater 274 and nerve root 276 displacements in the vertebral column canal space 270, forms space 280 thus.Remote organization's displacement can be advanced on ground, distally visualizer 278 in observation space 280, pass observation space 280 and observe local pathology.When this zone of assessment, can determine optimized treatment course of action.For example, observe the disc annulus 282 of tearing, as shown in Figure 12 C.Can select necessary instrument 265,268 (such as blade, aspirating mechanism, flushing machine etc.) and make it pass different operation path (not illustrating separately) to be deployed in the working space 280.The ring repair process can be observed by visualizer 278.When finishing reparation, removal equipment, recovery organization operation/space forms device, and takes out access to plant from the patient back.
Except method as herein described or part, the present invention includes and with subject apparatus or to pass through method and/or the effect that other means are implemented.Each method can all comprise provides the suitable device or the step of system.This preparation can be implemented by the end user.In other words, " provide " that (such as induction system) only requires that the end user obtains, enters, approaching, location, be provided with, activate, increase power (powerup) or do in order to device essential in the subject methods to be provided with other mode.Method cited herein can be implemented by feasible in logic any order of enumerating incident and by the incident order of enumerating.
The details that each illustrative aspects of the present invention has been described above and has selected and make about material.As for other details of the present invention, can understand in conjunction with above-mentioned patent and publication and those skilled in the art those aspects known usually or that understand.With regard to other effect of common or logical application, like this equally about the aspect based on method of the present invention.
In addition, although with reference to several embodiment that randomly comprise different characteristic the present invention has been described, the present invention is not limited to be described or to be illustrated as with respect to contemplated those of various modification of the present invention.Under the situation that does not depart from true spirit of the present invention and scope, can make various changes to foregoing invention, and can replace being equal to scheme (no matter be that this paper enumerates or for not comprising for simplicity).In addition, the place providing numerical range should be appreciated that, each intermediate value between the upper and lower bound of scope and any other setting value or intermediate value in set point all are included in the scope of the present invention.
Any optional feature of also imagining described invention modification all can be individually or is suggested and advocates with any one or a plurality of combining in the feature described herein.About singular item, comprise the probability that has a plurality of identical items.More specifically, in this paper and the appended claims all singulative " ", " described " and " being somebody's turn to do " comprise that plural number refers to object, except as otherwise noted.In other words, in above-mentioned description and appended claims, to use permission " at least one " theme article of object.Should also be noted that claims may be formulated as has got rid of any optional element.Therefore, this statement is intended to as the basis of using " only ", " only " and suchlike exclusiveness term (with advocating that quoting of element combines) or using " bearing " to limit.
Under the situation of not using this exclusiveness term, term in claims " comprises " can allow to comprise any other element---no matter be to have enumerated the element of giving determined number in the claim, still increase the character that a feature can be considered to change the element described in the claim.Except this paper clearly limit, all technology used herein and scientific and technical terminology all should be endowed the implication of common sense as far as possible widely, and keep the effectiveness of claim simultaneously.
The embodiment and/or the subject specification that are provided is provided range of the present invention, but only limited by the speech range of claim.

Claims (19)

1. system that is used to enter target site in the body, described system comprises:
Sleeve pipe, described sleeve pipe has at least one chamber;
Visualizer, described visualizer can pass described at least one casing cavity and carry; With
At least one strut, described strut can launch from telescopic distal part, wherein, launches described at least one strut and form a space in the tissue of contiguous telescopic distal part, and described space helps by scopic observation.
2. the system as claimed in claim 1 is characterized in that, described at least one strut launches on the distally of telescopic distal part.
3. the system as claimed in claim 1 is characterized in that, described at least one strut launches on the side direction of telescopic distal part.
4. the system as claimed in claim 1 is characterized in that, each strut limits a ring upon deployment.
5. the system as claimed in claim 1, described at least one strut limit a spiral or coiling configuration upon deployment.
6. the system as claimed in claim 1 is characterized in that, described at least one strut limits a framework upon deployment.
7. the system as claimed in claim 1 also comprises a plurality of struts, and wherein said strut limits one upon deployment and has the loop configurations of central opening, passes described central opening, and visualizer has the uncrossed visual field.
8. system that is used to enter target site in the body, described system comprises:
Sleeve pipe, described sleeve pipe has at least one chamber;
Visualizer, described visualizer can pass described at least one casing cavity and carry; With
Silk thread, described silk thread can launch from telescopic distal part, wherein, launches silk thread and form a space in the tissue of contiguous telescopic distal part, and described space helps by scopic observation.
9. system as claimed in claim 8 is characterized in that described silk thread launches on the distally of telescopic distal part.
10. system as claimed in claim 8 is characterized in that described silk thread launches on the side direction of telescopic distal part.
11. system as claimed in claim 8 is characterized in that, described silk thread limits a ring upon deployment.
12. system as claimed in claim 8 is characterized in that, the size adjustable of described ring.
13. system as claimed in claim 8 is characterized in that, described silk thread limits a spiral or coiling configuration upon deployment.
14. system as claimed in claim 8 is characterized in that, described silk thread limits a framework upon deployment.
15. system as claimed in claim 8 is characterized in that, described framework is positioned substantially on the side direction of scopic far-end.
16. system as claimed in claim 8 is characterized in that, the far-end of described silk thread is freely.
17. system as claimed in claim 16 is characterized in that, the far-end of described silk thread is fixed on the sleeve pipe.
18. system as claimed in claim 8 is characterized in that, at least one end of described silk thread is fixed on the sleeve pipe.
19. system as claimed in claim 8 is characterized in that, described silk thread comprises NITNOL.
CN200680054506.4A 2006-03-10 2006-03-10 Percutaneous access and visualization of the spine Pending CN101528110A (en)

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EP1993428A4 (en) 2010-04-14

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