Source: https://patents.google.com/patent/CN102458273A/en
Timestamp: 2018-03-17 07:15:00
Document Index: 186982873

Matched Legal Cases: ['Application No. 61', 'application No. 61', 'application No. 61', 'application No. 61', 'application No. 14', 'application No. 61', 'art 502']

CN102458273A - Tissue modification devices and methods - Google Patents
CN102458273A
CN102458273A CN 201080026422 CN201080026422A CN102458273A CN 102458273 A CN102458273 A CN 102458273A CN 201080026422 CN201080026422 CN 201080026422 CN 201080026422 A CN201080026422 A CN 201080026422A CN 102458273 A CN102458273 A CN 102458273A
CN 201080026422
CN102458273B (en )
内斯托·C·坎托纳
杰弗瑞·L·布雷施
罗伊·勒奎德勒奎德
罗伯特·加拉贝迪安
罗纳德·勒奎德勒奎德
迈克尔·P·瓦蕾斯
巴克萨诺公司
组织改变装置和方法 Tissue modification device and method
[0002] 本专利申请要求下述申请的优先权：2009年5月4日提交的标题为“TISSUE MODIFICATION DEVICES”的美国临时申请号61/175，323 ；2009年10月23日提交的标题为"SPINAL BONE CUTTING DEVICES AND METHODS”的美国临时申请号61/254，638 ；和2009 年12月10日提交的标题为“SPINAL BONE CUTTING DEVICES AND METHODS”的美国临时申请号61/285， 188。 [0002] This patent application claims priority to the following applications: The title May 4, 2009 entitled "TISSUE MODIFICATION DEVICES" U.S. Provisional Application No. 61 / 175,323; Title October 23, 2009 filed "SPINAL BONE CUTTING DEVICES aND METHODS" US provisional application No. 61 / 254,638; and the title December 10, 2009 entitled "SPINAL BONE CUTTING DEVICES aND METHODS" US provisional application No. 61/285, 188.
[0003] 本专利申请也是2009年7月1日提交的标题为“ACCESS AND TISSUE MODIFICATION SYSTEMS AND METHODS”的美国专利申请系列号12/496，094的部分继续申请，所述美国专利申请系列号12/496，094要求2008年7月1日提交的标题为“INNER SPINOUS DISTRACTION ACCESS AND DECOMPRESSION SYSTEM”的美国临时申请号61/077，441 的权益。 [0003] This patent application is also the title July 1, 2009 entitled "ACCESS AND TISSUE MODIFICATION SYSTEMS AND METHODS" part of US Patent Application Serial No. 12 / 496,094 a continuation application, the US Patent Application Serial No. 12 title / 496,094 claims the July 1 entitled "INNER sPINOUS DISTRACTION ACCESS AND DECOMPRESSION SYSTEM" benefit of US provisional application No. 61 / 077,441 of.
[0004] 本专利申请也是2009年7月14日提交的标题为“TISSUE MODIFICATION DEVICES” 的PCT申请系列号PCT/US09/50492的部分继续申请，所述PCT申请系列号PCT/US09/50492 要求下述申请的优先权：2008年7月14日提交的美国临时申请号61/080，647 ;2008年7 月17日提交的美国临时申请号61/081，685 ；和2009年3月26日提交的美国临时专利申请61/163，699。 Part [0004] The present patent application is also a title July 14, 2009 entitled "TISSUE MODIFICATION DEVICES" PCT Application Serial No. PCT / US09 / 50492 a continuation application, the PCT Application Serial No. PCT / US09 / 50492 claim the said priority application: US provisional application No. 14 July 2008, filed 61 / 080,647; US provisional application No. 61 2008, filed July 17 / 081,685; and March 26, 2009 filed US provisional Patent application 61 / 163,699.
[0005] 通过引用方式并入 [0005] incorporated by reference
[0006] 在本说明书中提及的所有出版物和专利申请都以全文引用方式并入本文中，其程度如同具体地且单个地说明每篇单独的出版物或专利申请通过引用方式并入。 [0006] All publications and patent applications mentioned in this specification are herein incorporated by reference in its entirety, the same extent as if individually described and particularly if each individual publication or patent application is incorporated by reference.
[0007] 本文描述了用于以使对周围组织、尤其是脊神经和脉管系统的潜在损伤最小化的方式切割脊椎骨和软组织的系统、装置和使用它们的方法。 [0007] Described herein is used to make the surrounding tissues, especially the potential damage to the spinal nerves and vasculature in a manner to minimize the cutting of the spine and the soft tissue system, apparatus, and methods of using them. 本文所述的方法、装置和系统可以用作脊椎外科手术的一部分，所述脊椎外科手术涉及脊椎骨或关节的完全或部分去除， 例如椎板切除术、椎板切开术、椎骨关节面切除术、椎弓根切除术等。 The methods described herein, apparatus and system for spinal surgery may be used as part of a spinal surgery involving complete or partial removal of the joint or the vertebra, for example, laminectomy, laminotomy, resection of vertebral articular surface pedicle resection and so on.
[0008] 外科手术可能需要在紧密靠近一条或多条神经的位置操作一个或多个医疗装置， 这可能具有损伤神经组织的风险。 [0008] The surgical operation may require one or more medical devices in close proximity to the location of one or more nerves, which may have a risk of damage to nerve tissue. 例如，可以使用医疗装置来切割、提取、缝合、凝结或以其它方式操作组织，包括接近或邻近神经组织的组织。 For example, the medical device may be used to cut, extraction, suture, coagulate or otherwise manipulate tissue, including nerve tissue near or adjacent tissue. 脊柱减压是一类可以用于去除触碰脊神经的组织的手术。 Spinal Decompression is a type of surgery can be used to remove tissue touch of the spinal nerve. 如果在精确地去除骨或骨的一部分的同时，能够以避开或保护附近的结构（诸如神经）的方式切割或操作组织（和尤其是骨），将是有益的。 If at the same time precisely removing a portion of bone or bone, it is possible to avoid or near the protective structure (such as neural) operation of cutting or tissue way (and especially bone), it would be beneficial.
[0009] 例如，穿孔腰椎椎体间融合（“TLIF” )手术是稳定脊椎椎骨和椎盘或椎骨之间的减震器的外科技术。 [0009] For example, the perforations between lumbar interbody fusion ( "TLIF") surgery is a surgical technique of a shock absorber between the vertebrae and the disc stabilizing the spine or vertebrae. 在该手术中，腰椎融合手术会在毗邻的椎骨之间建立牢固的结构（骨和/或椎体间装置），消除骨之间的任何移动。 In this surgery, lumbar fusion surgery creates a robust structure (bone and / or interbody device) between adjacent vertebrae, to eliminate any movement between the bone. 该外科手术的目的是，减少疼痛和神经刺激。 The purpose of the surgery is to reduce the pain and nerve stimulation. 该手术通常包括去除大量脊椎骨，例如，通过切开患者的背部，并去除小关节以建立开口，该开口中可以插入隔离件或椎体间笼，并用骨移植材料填充。 The procedure generally includes removing a large number of vertebrae, e.g., by cutting the patient's back, and removing the facet joint to create an opening, the opening can be inserted between the vertebral spacer or cage, and filled with bone graft material. 椎体间装置如笼或隔离件通常是8mm宽至15mm宽。 Interbody cage or spacer means, such as typically 8mm to 15mm wide width. 然后可以使用椎弓根螺钉和杆或板来融合椎骨。 You may then be used pedicle screw and rod or plate to fuse the vertebrae.
[0010] 通常进行椎板切除术作为TLIF手术的一部分，以便提供插入隔离件或笼的空间。 [0010] Generally laminectomy was performed as part of TLIF procedure, in order to provide space to insert the spacer or cage. 诸如后路腰椎间融合（PLIF)手术等其它类似手术也涉及从脊柱切掉和去除一部分骨，诸如去除下关节突（IAP)的一部分。 Such as posterior lumbar fusion between other similar procedures (the PLIF) surgery, and also relates to a portion of the cut portion of the bone is removed, such as removal of the inferior articular process (IAP) from the spinal column. 这些相对较大的骨部分的去除可能是困难的，且可能需要穿过大量其它健康组织进行切割。 These relatively large portion of the bone removal may be difficult and may require a large number of otherwise healthy tissue through the cut. 另外，穿过骨进行切割的工作可能损伤附近的组织，包括神经组织，诸如与要改变的背柱区域中的脊柱紧密结合的神经根。 Further, through the bone cutting work may damage nearby tissue, including nerve tissue, such as nerve roots bind tightly to the column to change the dorsal region of the spine. 对在骨和其它组织中产生多个切口（它们通常依次进行）的需要，可能加剧上述手术和其它这样的外科手术的风险和困难。 Generating a plurality of cutouts in need of bone and other tissues (which are typically sequentially performed), risks and difficulties may exacerbate the above-described operation, and other such surgical procedure.
[0011] 另外，必须困难地进行手术（诸如涉及切除脊椎骨的那些）来到达目的区域，且进行的外科手术可能必然地需要在狭窄的且弯曲的路径中移动。 [0011] Further, the operation must be carried out with difficulty (such as those involving removal of the vertebrae) to reach the surgical target region, and may be carried out necessarily need to be moved in a narrow and curved path. 因而，特别感兴趣的是，提供这样的装置：其是非常小型的（low profile)，或适合与现有的小型外科装置和系统一起使用。 Thus, of particular interest it is to provide such a device: it is very small (low profile), or suitable for use with conventional systems and minor surgical means. 还有益的是，提供这样的装置：其能够在组织的不同位置（例如，骨）同时产生多个切 It is also advantageous to provide this means: capable of generating a plurality of different locations simultaneously cut tissue (e.g., bone)
[0012] 本文描述了可以解决上述许多问题且满足确定需要的装置、系统和方法。 [0012] described herein can solve many of the above problems and satisfies the apparatus, a system and method for determining required. 发明内容 SUMMARY
[0013] 本文描述了用于切割预定的脊柱区域的装置、系统和方法。 [0013] Described herein are devices, systems and methods for cutting a predetermined area of ​​the spine.
[0014] 一般而言，本文所述的方法包括，制作2个穿过脊柱骨的切口（例如，穿过脊柱的根、椎板或其它骨区域）。 [0014] In general, methods described herein include, making two incisions (e.g., through the root of the spine, or other bone lamina area) through the spine. 可以同时地（例如，使用这样的装置，其具有2个可以并行设置的切割元件）或先后地制作所述切口。 It may be simultaneously (e.g., using such a device, which has two cutting elements may be arranged in parallel) or sequentially to produce the cut. 所述方法通常从围绕靶骨区域递送导丝开始。 The method generally begins at the bone surrounding the target area to deliver the guidewire. 所述导丝从第一位置进入体内，绕过靶骨，在第二位置离开身体。 The guide wire into the body from a first position, bypasses the target bone, leaving the body in the second position. 使用一个或多个针、插管等（它们可以随着导丝插入而引导导丝），可以定位导丝。 Using one or more needles, cannulas and the like (which may be guided with the guide wire into a guide wire), may be positioned guidewire. 该方法描述在许多专利中，这些专利在上面通过引用方式并入。 This method is described in many patents, which are incorporated by reference above. 导丝的远端端部可以是尖锐的，因而随着从近端端部推动导丝，它可以穿透组织。 The distal end of the guidewire may be sharp, so as to promote the guidewire from the proximal end, it can penetrate tissue. 导丝的近端端部可以适合牢固地（且可移去地）连接至切割装置的远端端部，诸如切割线锯。 The proximal end of the guidewire can be suitably fixedly (and removably) connected to the distal end of the cutting means, such as cutting wire saw.
[0015] 围绕要切割的靶骨穿过导丝以后，可以使用电极或其它神经定位装置（如在上文中以全文并入的一些参考文献中所述）来确认神经（例如，脊神经）没有位于导丝和要切割的骨之间，否则会损伤神经。 [0015] around the target to be cut through the bone after the guide wire, the electrode may be used or other neurological positioning means (e.g., several references in incorporated in the above) to confirm the nerve (e.g., the spinal nerve) is not located between the guide wire and bone to be cut, otherwise it will damage nerves. 例如，经由导丝联接部件，可以将条带形神经定位装置（具有相对扁平的且柔性的特性）的远端端部联接至导丝的远端端部，并围绕骨拉入位置，然后通过将电流施加于神经定位装置表面上的电极来进行刺激，以证实神经不存在。 For example the distal end, through the guide wire coupling member may be strip-shaped neural positioning means (having a relatively flat and flexible properties) coupled to the distal end of the guidewire, and pulled into position around the bone, then by applying current to the electrodes positioned on a surface of the device to stimulate the nerve, to confirm the absence of nerves. 如果神经存在于靶骨和神经定位装置之间，可以取出导丝并重新定位，然后重复检测过程。 If the target is present between the nerve and the nerve bone positioning means, the guide wire may be removed and repositioned, and then repeat the measurement process. 可以使用其它神经定位方法或装置，包括视觉检测/神经位置确认、通过电阻抗测量来检测、超声寸。 Positioning method may be used, or other neurological apparatus, including a visual detection / confirmation neural position is detected by electrical impedance measurements, ultrasound inch.
[0016] 一旦将导丝定位在用于切割骨的切割元件要经过的理想路径，通过使用导丝把它拉入位置，可以定位保护元件（例如，盖、罩等）。 [0016] Once the guidewire is positioned over the path of the cutting element to cut through the bone is used, by using a guide wire to pull it into position, the protective element can be positioned (e.g., lid, cover, etc.). 在一些变体中，将神经定位装置构造成罩或盖。 In some variations, the nerve location device configured to cap or cover. 例如，罩或盖可以是扁平的、薄的且柔性的长形的（例如，带状的）物体，其可以使用导丝定位。 For example, the cover or lid may be flat, flexible, thin and elongate (e.g., belt-like) object, the guidewire positioning may be used. 所述保护元件可以包括导丝的通道或路径。 The protective member may include a channel or path of the guidewire. 在一些变体中，在将保护元件的远端端部联接至导丝以后，使用导丝，可以将保护元件拉（例如，向远侧拉）入位置，然后可以向近端推动导丝，使得导丝的近端端部向后伸出患者，并可以联接第二元件（例如，切割元件），同时保护装置的远端端部保持就位。 In some variations, the distal end portion of the protective element coupled to the guidewire later, using a guide wire can be pulled protective element (e.g., pull distally) in position, the guidewire may then be pushed proximally, such that guidewire proximal end rearwardly projecting the patient, and may be coupled to a second element (e.g., cutting element), while protecting the distal end of the device held in place. 在一些变体中，可以使第二导丝沿着相同或平行的路径穿过组织，以定位其它元件，诸如切割元件。 In some variations, the second guidewire may be passed through the tissue along the same path or parallel to the other positioning elements, such as a cutting element. 在保护元件中/上的通道可以辅助该操作。 In the protective element on the channel / may assist in this operation. 或者，在一些变体中，所述保护元件可以定位在导丝外面，而不是联接至远端端部。 Alternatively, in some variations, the protective element may be positioned outside of the guide wire, rather than coupled to the distal end portion.
[0017] 一旦围绕要切割的靶骨的路径已被确定（和在一些变体中，被保护），然后可以如下定位诸如线锯等切割工具：将切割工具联接至导丝末端，并牵拉导丝，以拉动切割工具(例如，线锯）就位。 [0017] Once the target bone to be cut around the path has been determined (and in some variations, is protected), may then be positioned below the cutting tool, such as a wire saw or the like: the cutting tool is coupled to the guidewire tip, and pulling the guide wire, to pull the cutting tool (e.g., a wire saw) into place. 所述切割工具最佳地是薄的、柔性的切割工具，其可以双手使用，例如， 通过牵拉装置的近端端部和远端端部两者来切割骨。 The best cutting tool is a thin, flexible cutting tool, which can be used with both hands, for example, to cut the bone by both the proximal and distal ends of the pulling means. 切割装置的实例包括往复式切割装置，它们的一些实例在下文描述。 Examples of a reciprocating cutting device comprises a cutting means, several examples of which are described below. 切割元件可以是磨蚀的（例如，具有磨蚀表面）。 The cutting element may be an abrasive (e.g., abrasive surface). 切割元件可以是线锯，诸如季格利（Gigli)锯，如本领域已知的，其适用于本文所述的用途。 The cutting element may be a wire saw, such as quaternary Gurley (Gigli) saws, known in the art as, suitable for use as described herein. 切割元件不限于机械切割器。 The cutting element is not limited to a mechanical cutter. 其它切割元件可以包括电切割元件、热量（热）切割装置等。 Other cutting element may include an electrical cutting element, heat (thermal) cutting means and the like.
[0018] 在一些变体中，不使用单独的导丝，但是切割元件起导丝的作用。 [0018] In some variations, no separate guide wire, but the cutting element acts as a guidewire. 例如，切割元件可以包括集成在远端端部的导丝。 For example, the cutting element may include an integrated guidewire distal end. 在一些变体中，可以将导丝适配为切割元件。 In some variations, the guide wire can be adapted to the cutting element.
[0019] 一旦围绕靶组织实现定位，可以用手抓紧或用辅助装置抓紧切割元件的端部，并可以致动切割元件（例如，通过手工往复）来切割骨。 [0019] Once positioned around the target tissue to achieve, by hand or gripping portion gripping an end of the cutting element with the auxiliary device, and that the movable cutting element (e.g., by manually reciprocating) to cut the bone. 切割骨通常是指，彻底切穿骨。 Generally refers to cutting the bone, completely cutting through the bone. 在将切割元件联接至导丝的变体中，通过在导丝的远端端部牵拉，可以使切割元件往复运动。 Coupling the guidewire to the variant of the cutting element by the distal end of the guidewire is pulled, the cutting element can be reciprocated.
[0020] 从患者外侧，可以进行导丝的手工往复。 [0020] from the outside of the patient, the guidewire may be manually reciprocate. 牵拉和/或往复的方向可以基于希望的切割方向。 Pulling and / or directions of the reciprocation may be based on a desired cutting direction. 例如，当希望在侧面切割骨（例如，上关节突或SAP)使得切口相对于脊柱在侧向的方向延伸时，牵拉从患者伸出的切割元件的近端端部和远端端部（或连接到切割元件上的导丝或其它丝的一部分，所述部分从患者伸出，并可以被抓紧以操纵装置），通过在通常侧向的方向以角点牵拉2个端部，施加力向量。 For example, the side surface cut bone when it is desired (e.g., a facet or SAP) such that the cut with respect to the extending direction of the spine at the side of the proximal portion and a distal end portion of the cutting element projecting from the patient pulls ( or to a portion of the guidewire or other member on the cutting wire, extending from the portion of the patient, and to manipulate the gripping means may be), by pulling the two end corner portion in a direction generally laterally applying force vector. 一般而言，使用本文所述的柔性丝系统的切割方向，由从两端牵拉柔性切割元件的端部所产生的力向量决定。 Generally, the cutting direction using the flexible wire system described herein, the force vector pulling the end portion of the flexible cutting element from both ends of the produce. 牵拉力可以是交替的， 例如，使切割元件抵靠着组织往复运动。 A pulling force may be alternating, e.g., tissue against the cutting element to reciprocate.
[0021] 在一些变体中，随着切割元件抵靠着脊柱往复运动，可以使用辅助或引导元件来帮助定位切割元件。 [0021] In some variations, as the cutting element to reciprocate against the spine, the guide element may be used to assist or help position the cutting element. 例如，辅助装置或引导器可以推动切割元件抵靠着组织，帮助控制切割方向。 For example, the auxiliary device may push or guide the cutting member against the tissue, to help control the cutting direction.
[0022] 本文所述的方法可以包括这样的装置，其构造成允许同时切割两个或更多个骨区域。 The methods described herein [0022] may include a device configured to allow two or more simultaneously cut bone region. 例如，用于切割骨的装置可以包括2个平行的切割元件，它们被预定的隔离件或间距隔开。 For example, means for cutting a bone may comprise two parallel cutting elements, which are spaced apart a predetermined spacing or spacer. 切割元件的远端和近端端部区域是相连的，所以使装置的端部往复运动会造成两个切割元件的往复运动。 A distal end and a proximal end region of the cutting element are connected, so that the end portion of the reciprocating means causing reciprocation Games two cutting elements. 如所述的，切割元件通常是柔性的，且可以连接，使得它们保持被预定的间距隔开，甚至当接触骨时或在定位过程中。 As described, the cutting element is generally flexible, and can be connected, so that they remain separated by a predetermined distance, even when in contact with the bone or in the location process. 例如，2个平行的切割元件可以被下述距离隔开：约4-16mm，或约6_14mm，或约8_15mm。 For example, two parallel cutting elements may be spaced apart from the following: about 4-16mm, or about 6_14mm, or about 8_15mm. 2个（或在一些变体中，超过2个)切割元件通常沿着装置的长轴（长度）设置。 2 (or in some variants, more than 2) disposed generally along the long axis of the cutting element (length) of the device. 在一些变体中，所述切割元件可以是大致平行的或实际上平行的。 In some variations, the cutting element may be substantially parallel or practically parallel. 在一些变体中，所述切割元件是不平行的，例如，切割表面可以相对于彼此稍微成角度，且所述装置可以构造成，使得切割边缘之间的距离可以变化或改变。 In some variations, the cutting element is non-parallel, e.g., with respect to the cutting surface may be at a slight angle to each other, and the device may be configured so that the distance between the cutting edges may be varied or changed.
[0023] 在先后地（而不是平行地）制作两个或更多个切口来去除骨的一部分的变体中， 所述方法可以包括，切割骨的第一部分，然后移动切割元件到第二切口的起点，无需从组织取出切割元件。 [0023] In in succession (not in parallel) two or more notches made to remove a portion of the bone variant, the method may include cutting a first portion of the bone, and then move the cutting member to the second notch starting point, without removing the tissue from the cutting element. 因而，可以制作用于去除骨的切口的两侧，无需取出切割元件。 Thus, both sides can be made for removing the cut bone, without having to remove the cutting element. 无需从身体取出柔性切割元件（例如，丝）就可以完全切掉一段骨，是本文所述的方法的一个优点。 Removed from the body without the flexible cutting element (e.g., wire) can be completely cut off section of the bone, is an advantage of the process described herein. [0024] 当如上所述先后制作2个切口时，可以使用额外的定位装置来推、拉或以其它方式引导切割元件的中间（例如，围绕骨成环的区域）进入围绕骨的位置，在希望的第二切割位置处。 [0024] When production has two notches as described above, additional positioning means to push, pull, or otherwise intermediate guiding the cutting element (e.g., a ring surrounding the bone area) into the position around the bone, in the second cut at the desired location. 例如，可以使用线锯来从侧面切割SAP，然后，在彻底切穿SAP以后，通过推动它或滑动它到第二位置，可以使在组织中的切割元件的弯曲部分移动就位。 For example, a wire saw to cut from the side of SAP, then, after completely cutting through the SAP, which by pushing or sliding it to the second position, the curved portion can move the cutting element in place in the tissue. 在下文提供了一个这样的实施例。 Below provides one such embodiment. 定位装置可以是刚性的或坚硬的部件，其具有构造成推或抓切割元件的环的远端端部。 Positioning device may be rigid or stiff member having a distal end portion of the ring is configured to push or grip the cutting element. 由于被切割的骨将被取出，在一些变体中，所述手术包括下述步骤：切穿组织以暴露骨。 Because bone is cut to be removed, in some variations, the procedure comprising the steps of: cutting through the tissue to expose the bone. 可以将一个或多个探针插入该切口，并用于如下定位丝：使用操纵装置，一旦它根据需要已经围绕组织成环；或定位探针，以围绕要切割的骨穿过导丝。 One or more probes may be inserted into the incision and positioning the wire used in the following: the use of actuating means, once it has been necessary, tissue surrounding the ring; or a probe positioned to surround a bone to be cut through the wire.
[0025] 尽管可以形成进入骨中的开口来去除被切掉的骨区域，可能有益的是，从单独的(甚至微创的）接近点围绕靶骨穿过导丝。 [0025] Although the opening may be formed into the bone region of the bone removed is cut away, it may be beneficial, from a separate guide wire through the access point (or even less invasive) around the target bone. 因而，为了去除骨而进入组织中的切口可以保持相对较小（例如，足够大到刚好取出被切掉的骨），同时可以在线锯将要往复运动的方向穿过组织形成线锯的单独路径。 Accordingly, in order to remove the bone tissue into the incision can be kept relatively small (e.g., just large enough to remove the bone is cut off), while the direction of the wire saw can be formed through tissue reciprocating saw wire separate paths. 在其它变体中，可以基本上“开放地”进行手术，暴露出骨区域，并允许操纵必要的导丝和/或切割元件的端部，以在希望的角度进行切割，并去除骨。 In other variations, it may be substantially "open to" surgery to expose the bone region, and allow manipulation of the guidewire necessary and / or an end portion of the cutting element to the desired angle of cut and remove bone.
[0026] 在一些变体中，本文所述的方法适用于切割脊椎骨关节面（spinal facet)区域(例如，在上关节突的一侧切割），具体地，以允许插入诸如笼或隔离件等装置。 [0026] In some variations, the methods described herein is suitable for cutting the articular surface of the backbone (spinal facet) region (e.g., at a side of the cut articular processes), in particular, to allow insertion member such as a cage or the like separator device. 下文描述了一个手术的一个具体实施例，和可以用于进行手术的装置的变体，以及包括这样的装置的系统。 The following describes a procedure of a specific embodiment and variants thereof may be used for the surgical device, and a system comprising such apparatus. 在一些变体中，本文所述的方法和装置适用于切割骨，以进行截骨术。 In certain variations, the methods and apparatus described herein is suitable for cutting bone, for osteotomy. 例如，在脊柱侧凸减轻外科手术中，去除骨的一部分，以辅助脊柱的矫直。 For example, to alleviate scoliosis surgery, removing a portion of the bone to assist in straightening the spine. 在一些变体中，本文所述的方法和装置适用于切割棘突或横突或骨的任意其它合适的部分。 In some variations, the methods and apparatus described herein for cutting the spinous processes or other suitable portion of any transverse or bone.
[0027] 本文还描述了改进的用于改变组织的装置及其使用方法。 [0027] Also described herein is an improved apparatus and method of use for changing the tissue. 这些装置可以被包括为用于改变组织的系统的一部分。 These means may be included as part of the system for changing the tissue. 本文所述的组织改变装置通常包括长形柔性元件和与该柔性元件联接的组织改变元件。 The tissue modification device described herein generally comprises an elongate flexible element and the coupling element and the flexible element organization change. 所述柔性元件可以包括扩展机构，其使柔性元件的至少一部分从第一宽度扩展为第二宽度。 The flexible member may include an extension mechanism which at least a portion of the flexible element from a first width to a second width extension. 组织改变装置可以包括这些特征中的一个或多个特征的任 Tissue modification device may include one or more of any of these features are
思组合。 Thinking combination.
[0028] 本文所述的改变组织的方法可以包括下述步骤中的一个或多个步骤：插入具有第一宽度的长形柔性元件；使柔性元件前进，直到柔性元件的一部分邻近靶组织；至少扩展邻近靶组织的柔性元件部分至第二宽度；以及用柔性元件改变靶组织。 [0028] The method described herein altered tissue may comprise the steps of one or more steps of: inserting an elongated flexible member having a first width; the flexible element is advanced until a portion of the target tissue adjacent to the flexible element; at least target tissue adjacent the extended portion of the flexible member to a second width; and changing the target tissue with a flexible element.
[0029] 或者，所述的改变组织的方法可以包括下述步骤中的一个或多个步骤：在第一位置处，将第一长形柔性元件插入患者中；使第一柔性元件前进，直到柔性元件的一部分邻近靶组织；在所述第一位置处，将第二长形柔性元件插入患者中，其与第一柔性元件保持一定距离；以及用柔性元件改变靶组织。 [0029] Alternatively, the method of changing the tissue may comprise the steps of one or more of the steps: at a first location, the first elongated flexible element is inserted into the patient; the first flexible member forward until a portion of the flexible member adjacent the target tissue; at the first position, the second flexible elongate member inserted into a patient, with the first flexible member to maintain a certain distance; and changing the target tissue with a flexible element.
[0030] 本文所述的任意装置可以用作组织减压（例如，脊椎减压）方法的一部分，以改变组织如软组织（例如，黄韧带等）和硬组织（例如，骨）。 [0030] any of the devices described herein may be used as part of a method of tissue (e.g., spinal decompression) under reduced pressure, to alter the tissue such as soft tissue (e.g., yellow ligament, etc.) and hard tissues (e.g., bone). 具体地，这些装置可以用作椎孔内的脊椎减压技术的一部分。 Specifically, these means may be used as part of the vertebral spine hole art under reduced pressure.
[0031] 本文所述的装置可以用作基于引导的接近和减压系统的一部分，包括以前在下述专利申请和临时专利申请（它们各自以全文引用方式并入本文）中的任一个中描述的那些：美国专利申请系列号11/250，332，标题为“DEVICES AND METHODS FOR SELECTIVE SURGICAL REMOVAL OF TISSUE”（10/15/2005 提交），美国专利申请系列号11/251，199， 标题为“DEVICES AND METHODS FOR TISSUE ACCESS”（10/15/2005)，美国专利申请系列号11/375，265，标题为“METHODS AND APPARATUS FOR TISSUE MODIFICATION” (3/13/2006 提交），美国专利申请系列号11/405,848，标题为“MECHANICAL TISSUE MODIFICATION DEVICES AND METHODS” (4/17/2006 提交），美国专利申请系列号11/429，377，标题为“FLEXIBLE TISSUE RASP” (5/4/2006 提交），美国专利申请系列号11/538，345， 标题为“ARTICULATING TISSUE CUTTING DEVICE” (10/3/2006 提交），美国专利申请系列号11/687,548，� [0031] The devices described herein may be used as part of a system under reduced pressure and close, previously comprising the following patent applications and provisional patent applications (each of which is incorporated herein by reference in its entirety) described in any one of the guide based those: US Patent application Serial No. 11 / 250,332, entitled "DEVICES AND METHODS FOR SELECTIVE SURGICAL REMOVAL OF TISSUE" (10/15/2005 submission), US Patent application Serial No. 11 / 251,199, entitled "DEVICES AND METHODS FOR TISSUE ACCESS "(10/15/2005), US Patent application Serial No. 11 / 375,265, entitled" METHODS AND APPARATUS FOR TISSUE MODIFICATION "(3/13/2006 submission), US Patent application Serial No. 11 / 405,848, entitled "MECHANICAL TISSUE MODIFICATION DEVICES AND METHODS" (4/17/2006 submission), US Patent application Serial No. 11 / 429,377, entitled "FLEXIBLE TISSUE RASP" (5/4/2006 submission), United States Patent application Serial No. 11 / 538,345, entitled "ARTICULATING TISSUE CUTTING DEVICE" (10/3/2006 submission), US Patent application Serial No. 11 / 687,548, �题为“TISSUE REMOVAL WITH AT LEAST PARTIALLY FLEXIBLE DEVICES”（3/16/2007 提交），美国专利申请系列号11/687，558，标题为“FLEXIBLE TISSUE REMOVAL DEVICES AND METHODS”（3/16/2007 提交），美国专利申请系列号11/870，370， 标题为"PERCUTANEOUS SPINAL STENOSIS TREATMENT” (10/10/2007 提交），和美国专利申请系列号12/127，535，标题为“GUIDEWIRE EXCHANGE SYSTEMS TO TREAT SPINAL STENOSIS” (5/27/2008 提交)。 Entitled "TISSUE REMOVAL WITH AT LEAST PARTIALLY FLEXIBLE DEVICES" (3/16/2007 submission), US Patent Application Serial No. 11 / 687,558, entitled "FLEXIBLE TISSUE REMOVAL DEVICES AND METHODS" (3/16/2007 submission) US Patent application Serial No. 11 / 870,370, entitled "PERCUTANEOUS SPINAL STENOSIS TREATMENT" (10/10/2007 submission), and US Patent application Serial No. 12 / 127,535, entitled "GUIDEWIRE EXCHANGE SYSTEMS tO TREAT SPINAL STENOSIS "(5/27/2008 submission).
[0032] 具体地，本文所述的装置可以用作基于导丝的系统，所述系统构造成，使得所述装置可以被牵拉就位和/或被拉紧从而推压组织，并从而改变组织。 [0032] In particular, the apparatus described herein may be used as a guidewire-based system, the system is configured such that the device can be pulled into place and / or pressed thereby tensioning tissue, and thereby changing organization. 该构型可以称作双手系统，因为可以拉紧或牵拉两个端部（例如，装置的近端端部和远端端部）来改变组织。 This system configuration may be referred to hands, since the pulling or tensioning the two ends (e.g., a proximal portion and a distal end portion of the device) to change the organization. 通过组织的去除或光滑处理，可以改变组织，且通过牵拉本文所述的装置穿过组织，使得工作表面（例如，在横档上的刀片）接触一个或多个组织表面，也可以改变组织。 By smoothing or removing tissue, tissue can be changed, and through the tissue by pulling apparatus described herein, such that the working surface (e.g., the crosspiece blade) in contact with the one or more tissue surfaces, tissue may also be varied .
[0033] 本文还描述了用于递送组织改变装置的递送装置，所述组织改变装置用于从患者去除组织。 [0033] Also described herein is a delivery device for delivering the tissue modification device, the tissue modification device for removal of tissue from a patient. 在一些实施方案中，所述装置包括条带形柔性长形主体，所述主体具有由第一边缘和第二边缘限定的宽度。 In some embodiments, the device comprises a strip-shaped flexible elongate body, said body having a defined width of the first and second edges. 在一些实施方案中，第一边缘和第二边缘是基本上平行的。 In some embodiments, the first and second edges are substantially parallel. 所述装置还可以包括第一通道和第二通道，所述第一通道构造成接收第一长形切割部件，沿着长形主体的长度的一部分设置，朝向长形主体的第一边缘定位，所述第二通道构造成接收第二长形切割部件，沿着长形主体的长度的一部分设置，朝向长形主体的第二边缘定位。 The apparatus may further comprise a first and second channels, the first channel configured to receive a first elongate cutting member, disposed along a portion of the length of the elongate body, the elongate body toward a first edge location, the second channel configured to receive a second elongate cutting member, disposed along a portion of the length of the elongate body, the elongate body toward the second edge is positioned. 在一些实施方案中，所述装置还可以包括导丝联接器，其在长形主体的远端端部区域处。 In some embodiments, the apparatus may further comprise a guidewire coupling, at an end portion thereof at a distal end region of the elongate body.
[0034] 在一些实施方案中，第一柔性长形切割部件被设置在第一通道内，和/或第二柔性长形切割部件被设置在第二通道内。 [0034] In some embodiments, the first elongate flexible cutting member is disposed within the first channel, and / or the second flexible elongate cutting member is disposed in the second passage.
[0035] 本文还描述了用于递送组织改变装置的方法，所述组织改变装置用于从患者去除组织。 [0035] Also described herein is a method for delivering the tissue modification device, the tissue modification device for removal of tissue from a patient. 在一些实施方案中，所述方法包括下述步骤：在第一位置处，将长形柔性罩插入患者中；使罩前进，直到罩的一部分邻近靶组织；穿过罩插入第一长形柔性切割元件，直到第一切割元件的一部分邻近靶组织；穿过罩插入第二长形柔性切割元件，其相距第一切割元件一定距离，且与第一切割元件基本上平行，直到第二切割元件的一部分邻近靶组织；以及用柔性元件改变组织。 In some embodiments, the method comprises the steps of: at a first location, the elongated flexible housing inserted into a patient; the cover advanced until a portion of the target tissue adjacent the shroud; inserted through a first elongate flexible cover the cutting element, adjacent to the target tissue until a portion of the first cutting element; through the cover inserted into the second elongated flexible cutting member, which first cutting element spaced a distance from, and substantially parallel to the first cutting element, the cutting element until the second adjacent the portion of the target tissue; and changing tissue flexible member.
[0036] 在一些实施方案中，所述方法包括下述步骤：插入第一长形柔性切割元件，直到第一切割元件的一部分邻近靶组织；使长形柔性罩在患者中前进，其中所述罩的一部分在第一长形柔性切割元件上面前进；穿过罩插入第二长形柔性切割元件，其相距第一切割元件一定距离，且与第一切割元件基本上平行，直到第二切割元件的一部分邻近靶组织；以及用柔性元件改变组织。 [0036] In some embodiments, the method comprises the steps of: inserting a first elongated flexible cutting element, adjacent to the target tissue until a portion of the first cutting element; that the elongated flexible housing proceeds in a patient, wherein said advancing a first portion of the cover is elongated flexible cutting element thereon; inserting the cover through the second elongated flexible cutting member, which first cutting element spaced a distance from, and substantially parallel to the first cutting element, the cutting element until the second adjacent the portion of the target tissue; and changing tissue flexible member. 在一些实施方案中，所述方法另外包括下述步骤：从患者取出罩，同时使切割元件在患者内保持就位。 In some embodiments, the method further comprising the step of: the cover removed from a patient, while the cutting element is held in place within the patient.
[0037] 在一些实施方案中，具有用于在患者中切割组织的组织改变区域的双手控制的组织改变装置包括一对沿着组织改变区域的长度延伸的柔性长形切割部件。 [0037] In some embodiments, a tissue in a patient having a tissue cutting tissue changes hands control region changing means comprises a length extending along a region of tissue changes of the flexible elongate cutting member couple. 每个长形切割部件可以具有厚度，且每个长形切割部件可以构造成在组织中切割分离的槽至大于切割部件厚度的深度。 Each elongate member may have a thickness of cut, and each of the elongate member may be configured as a cutting depth of the grooves cut in the tissue isolated to greater than the thickness of the cutting member. 在一些实施方案中，所述装置包括在装置的组织改变区域远侧的导丝联接器。 In some embodiments, the device comprises changing a distal region of guidewire coupling device in the tissue. 所述导丝联接器可以构造成联接到导丝上，例如，在导丝的近端端部处，且通过牵拉在装置上或连接至装置的近端手柄，和牵拉联接至装置的远端端部的导丝，可以致动组织改变区域。 Coupling the guidewire may be configured to be coupled to the guidewire, e.g., at the end to end at a portion near the guide wire and the device or by pulling on a handle connected to the proximal end of the device, and coupled to the pulling device the distal end portion of the guide wire may be actuated tissue change region. 在一些实施方案中，所述组织改变区域构造成由近端手柄和远端手柄致动。 In some embodiments, the tissue change region is configured to be actuated by a handle proximal end and a distal end of the handle. 在一些实施方案中，所述导丝联接器构造成，使得所述装置可移去地连接至导丝的近端端部区域，因而通过牵拉导丝，可以拉动组织改变区域就位，而导丝的近端端部区域被导丝联接器保持相对于装置静止。 In some embodiments, the guide wire coupling is configured such that removably connected to the proximal end region of the guide wire means, thereby pulling the guide wire through, tissue can be pulled into position change region, and the proximal region of the guidewire is held guidewire device is stationary relative to the coupling. 或者，在一些实施方案中，所述装置包括在组织改变装置的远端端部处的柔性引导器，其中所述引导器构造成，使得通过牵拉引导器，可以拉动组织改变区域就位。 Alternatively, in some embodiments, the tissue modifier means comprises a flexible distal end portion of the guide device, wherein the guide is configured such that by pulling the guide, tissue can be pulled into position change region.
[0038] 在一些实施方案中，至少一个切割部件包括切割丝，而在一些实施方案中，至少一个切割部件包括季格利丝或长形丝，所述长形丝具有沿着该丝的长度的螺旋形切割边缘。 [0038] In some embodiments, the at least one cutting element comprises a cutting wire, and in some embodiments, the at least one cutting element comprises a quaternary Geli Si or elongated filaments, said elongated filaments having a filament along the length of the the helical cutting edge. 在一些实施方案中，至少一个切割部件包括长形缆索，所述长形缆索具有沿着缆索的长度分布的刀刃。 In some embodiments, the at least one cutting member comprises an elongate cable, said cable having elongated cutting edges distributed along the length of the cable.
[0039] 在一些实施方案中，所述装置包括联接至组织改变区域的长形切割部件上的隔离件，其中所述隔离件形成合适的尺寸，并构造成将切割部件暂时保持为彼此相距一定距离。 [0039] In some embodiments, the tissue modification device comprises a spacer member coupled to the elongated cutting member on the region, wherein said spacer member is formed of a suitable size, and a cutting member configured to temporarily hold a certain distance from each other distance. 在一些实施方案中，所述隔离件包括长形柔性的、条带形的基质，且在一些实施方案中，所述隔离件包括联接器，所述联接器朝向隔离件的外缘区域，并构造成将切割部件暂时固定至隔离件的外缘区域。 In some embodiments, the spacer comprises an elongate flexible strip-shaped substrate, and in some embodiments, the spacer comprises a coupling member, the coupling member toward the peripheral region of the separator, and a cutting member configured to temporarily fix the spacer to the peripheral region. 在一些实施方案中，所述隔离件形成合适的尺寸，并构造成沿着长形切割部件的长度滑动。 In some embodiments, the spacer member is formed of a suitable size, and is configured to slide along the length of the elongate cutting member.
[0040] 在一些实施方案中，所述装置另外包括多个柔性连接的横档，其中每个横档至少部分地跨装置的宽度延伸。 [0040] In some embodiments, the apparatus further comprises a flexible connecting a plurality of rungs, wherein the width of each rung at least partially across the device extends. 在一些实施方案中，所述横档是在装置的组织改变区域的近端和远端。 In some embodiments, the crosspiece is changed at the proximal and distal region of the apparatus tissue. 在一些实施方案中，所述装置另外包括连接件，所述连接件连接邻近的横档。 In some embodiments, the device further comprises a connecting member, said connecting member connecting adjacent rungs. 在一些实施方案中，所述连接件可以包括至少一条缆索，且在一些实施方案中，所述缆索可以形成第一长形切割部件和第二长形切割部件。 In some embodiments, the connector may comprise at least one cable, and in some embodiments, the cable may be formed of a first elongate cutting member and a second elongate cutting member.
[0041] 一般而言，用于在患者中切割组织的双手控制的组织改变装置可以包括一对柔性的长形切割部件和隔离件，所述切割部件沿着装置的长形长度延伸，所述隔离件可以定位在切割部件之间。 [0041] In general, hand control for tissue cutting tissue in a patient changing means may comprise a pair of flexible elongate cutting member and the spacer member, said elongated cutting member extends along the length of the device, the spacers may be positioned between the cutting member. 在一些实施方案中，所述隔离件形成合适的尺寸，并构造成以两种模式之一操作：第一模式，其中所述隔离件被联接至切割部件，使得其保持2个切割部件中的每一个的一部分彼此相距一定距离；和第二模式，其中隔离件的至少一部分移动离开切割部件， 以允许切割部件更深入地切入组织。 In some embodiments, the spacer member is formed of a suitable size, and configured in one of two modes: a first mode wherein said spacer member is coupled to the cutting member, so that it remains in the cutting member 2 a portion of each distance from each other; and a second mode, wherein moving at least a portion of the cutting member away from the spacer, to allow the cutting member to cut deeper tissue. 在第一模式，所述隔离件可以在与切割部件相同的平面内，而在第二模式，所述隔离件可以移动到平面以外。 In the first mode, the spacer may be in the same plane as the cutting member, and a second mode, the isolation member can move beyond the plane.
[0042] 在一些实施方案中，所述长形切割部件彼此基本上平行。 [0042] In some embodiments, the elongated cutting member are substantially parallel to each other. 在一些实施方案中，处于第二模式的隔离件定位在切割部件平面以外。 In some embodiments, the spacer is positioned in the second mode than in the plane of the cutting member. 所述装置可以包括导丝联接器，其在组织改变装置的远端端部区域处。 The device may comprise a guidewire coupling, at the distal end region of the apparatus in which tissue changes. 在一些实施方案中，处于第二模式的隔离件被定位成，使得切割部件中的每一个可以切入组织中的深度大于切割部件的厚度。 In some embodiments, the spacer is positioned in the second mode such that each cutting member can cut a thickness greater than the depth of the cut tissue member. 在一些实施方案中，所述隔离件另外包括联接器，所述联接器构造成，当所述隔离件处于第一模式时，将隔离件联接至切割部件上。 In some embodiments, the spacer member further comprises a coupler, the coupler is configured to, when the spacer is in the first mode, the spacer member is coupled to the cutting member. 在一些实施方案中，随着切割部件切穿联接器，所述隔离件从第一模式转换为第二模式。 In some embodiments, as the cutting means cuts through the coupling, the spacer member from a first mode to a second mode. 在一些实施方案中，随着联接器沿着长形切割部件的长度滑动，所述隔离件从第一模式转换为第二模式。 In some embodiments, the coupling with the cutting along the length of the elongate slide member, said spacer member from a first mode to a second mode. 可以使用任意适当数目的隔离件。 You may use any suitable number of spacers. 相同的装置可以使用不同类型 The same apparatus can use different types
10或构型的隔离件。 10 or the configuration of the spacer.
[0043] 在一些实施方案中，所述联接器可以是可变形材料，其形成合适的尺寸，并构造成，随着可变形材料变形和隔离件的一部分相对于切割部件运动，所述隔离件从第一模式转换为第二模式。 [0043] In some embodiments, the coupling may be a deformable material, which forms a suitable size, and configured to, with a portion of deformable material and the spacer element for movement of the cutting member, said spacer member switching from the first mode to the second mode. 在一些实施方案中，所述装置另外包括弹簧，其中所述弹簧构造成，随着所述隔离件从第一模式转换为第二模式而伸展。 In some embodiments, the device further comprises a spring, wherein said spring is configured to, as the spacer member from a first mode to a second mode to stretch. 在一些实施方案中，切割部件形成合适的尺寸，并构造成，在所述隔离件处于第一模式时，在组织中切入第一深度，并在所述隔离件处于第二模式时，在组织中切入第二更大的深度。 In some embodiments, the cutting member is formed of a suitable size, and configured to, when the spacer member is in the first mode, the first depth of cut in the tissue, and when the spacer member is in the second mode, the tissue the second cut in greater depth. 在一些实施方案中，切割部件构造成由近端手柄和远端手柄致动。 In some embodiments, the cutting member configured to be actuated by a handle proximal end and a distal end of the handle. 切割部件可以往复运动，例如，它们可以被远端手柄拉向远端，并被近端手柄拉向近端。 Cutting member can be reciprocated, for example, they may be pulled toward the distal end of the handle distal end, and a proximal handle is pulled proximally.
[0044] 一般而言，改变组织的方法可以包括下述步骤：使长形柔性组织改变装置至少部分地围绕靶组织穿过；通过从装置的至少一个末端牵拉组织改变装置，使装置的组织改变区域抵靠着靶组织运动；并使用一对沿着组织改变区域的长形长度延伸的柔性长形切割部件，在组织中切割2个分离的长形槽。 [0044] Generally, the tissue changes following method may include steps of: changing elongated flexible tissue surrounding the device at least partially through the target tissue; by changing at least one end of the pulling means from the organization means that the organization means change region against the target tissue motion; and a flexible elongate cutting member of one pair change region along the length of tissue extending elongate cut two separate elongated slots in the tissue. 例如，所述长形切割部件可以具有厚度（例如，约0. Olcm至约5cm)，且长形槽中的每一个可以切入的深度大于切割部件的厚度。 For example, cutting the elongate member may have a thickness (e.g., from about 0. Olcm to about 5cm), and the depth of each groove can be cut into the elongated cutting member is larger than the thickness. 在一些实施方案中，所述长形槽各自具有大于Icm的深度。 ] In some embodiments, the elongated groove having a depth greater than each of Icm. 在一些实施方案中，所述长形槽各自具有大于2cm的深度。 In some embodiments, the elongated grooves each have a depth of greater than 2cm. 在一些实施方案中，所述长形槽彼此基本上平行。 In some embodiments, the elongated slot substantially parallel to each other.
[0045] 如所述的，所述槽通常是分离的，并彼此隔开。 [0045] As described, the grooves are usually separated and spaced apart from each other. 在一些变体中，随着装置继续切入组织（例如，骨），所述槽可以连通或汇合。 In some variations, as the device continues to cut tissue (e.g., bone), or the groove may be in communication confluent. 可以预定槽之间的间距（例如，4mm、5mm、6mm、 7mm、8mm、9mm、10mm、11mm、12mm、13mm、14mm、15mm、16mm、17mm、18mm 等)，这可以对应着切割装置上的切割元件之间的间距。 The spacing between the grooves can be predetermined (e.g., 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, etc.), which may correspond to the cutting means the spacing between the cutting elements.
[0046] 在一些实施方案中，所述方法另外包括取出靶组织的步骤。 [0046] In some embodiments, the method further comprises the step of extraction target tissue. 所述靶组织可以包括小关节的至少一部分。 The target tissue may comprise at least a portion of a facet joint. 在一些实施方案中，使组织改变装置至少部分地围绕靶组织穿过的步骤包括：使导丝至少部分地围绕靶组织穿过，并使用导丝围绕靶组织牵拉柔性组织改变装置。 In some embodiments, the tissue modification device at least partially through the step of surrounding the target tissue comprising: a guide wire at least partially through the tissue surrounding the target, and the target tissue using the guide wire is pulled around the flexible tissue modification device. 在一些实施方案中，切割步骤包括下述步骤：使用一对柔性长形切割部件，在组织中切割槽至第一深度，将所述柔性长形切割部件用隔离件保持为彼此相距一定距离，并用这对柔性长形切割部件，在组织中切割槽至第二更大的深度。 In some embodiments, the cutting step comprising the steps of: using a pair of flexible elongate cutting member, cutting the groove to a first depth in the tissue, cutting the flexible elongate member holding the spacer at a distance from one another, and a pair of flexible elongated cutting member, cutting grooves in the tissue to a second greater depth.
[0047] 在切割槽至第二更大的深度之前，隔离件可以相对于切割部件移动。 [0047] prior to cutting the groove to a second greater depth, the spacer can be moved relative to the cutting member. 在一些实施方案中，所述方法包括下述步骤：随着隔离件运动离开切割部件，用隔离件收集切割的组织。 In some embodiments, the method comprises the steps of: moving tissue away from the cutting element as the spacer member for collecting cut with spacers. 使组织改变装置抵靠着组织运动的步骤可以包括：向组织改变装置的近端端部和远端端部两者施加张力，以驱动组织改变装置同时或先后抵靠着组织运动（例如，使它往复运动）° Changing means against the tissue motion may include the step of organization: both the proximal and distal ends of the device applies tension to the tissue change, to change the drive means simultaneously or sequentially tissue against tissue motion (e.g., so that it reciprocation) °
[0048] 在一些实施方案中，所述方法包括下述步骤：在切割槽的同时，用切割部件中的至少一个切穿联接器，其中所述联接器将隔离件联接至切割部件上。 [0048] In some embodiments, said method comprising the steps of: simultaneously cut grooves, with at least one cut in the cutting member through coupling, wherein the coupling member is coupled to the spacer on the cutting member. 在一些实施方案中，所述方法包括下述步骤：在组织中切割槽的同时，使至少一个切割部件脱离联接器，其中所述联接器将隔离件联接至切割部件上。 In some embodiments, the method comprises the following steps: simultaneous cutting of grooves in the tissue, at least one cutting member from the coupling, wherein the coupling member is coupled to the spacer on the cutting member. 在一些实施方案中，切割步骤另外包括：通过用远端手柄向远侧牵拉组织改变区域，并通过用近端手柄向近侧牵拉组织改变区域，使装置的组织改变区域抵靠着靶组织往复运动。 In some embodiments, the cutting step further comprises: change region with the distal end of the handle by distally pulling tissue, and by changing the area of ​​tissue is pulled proximally with a proximal handle, so that changing means against the region of the target tissue organization reciprocating motion.
附图说明[0049] 图1A-1D图解了可以用于实现本文所述方法的元件；这些元件中的一些或全部(图IA的导丝，图IC的神经定位装置，图IB的柔性线锯，和图ID的平行线锯）可以形成用于切割组织的系统。 BRIEF DESCRIPTION [0049] Figures 1A-1D illustrate elements may be used to implement the methods described herein; some of these elements or all (FIG. IA guidewire, positioning means neural FIG IC, the flexible wire saw of FIG. IB and FIG saw ID parallel lines) may form a system for cutting tissue.
[0050] 图2-3D显示了切割丝的不同实施方案。 [0050] FIG. 2-3D show different embodiments of the cutting wire.
[0051] 图4图解了具有切割丝的组织改变装置。 [0051] FIG. 4 illustrates the organization changing means having a cutting wire.
[0052] 图5图解了切割关节面的侧面部分的方法。 [0052] FIG 5 illustrates a method of cutting the side portions of the articular surface.
[0053] 图6A图解了切割关节面的侧面部分的方法的变体。 [0053] FIG. 6A illustrates a variant of the method of cutting the side portions of the articular surface.
[0054] 图6B图解了切割关节面的方法的一个步骤。 [0054] FIG 6B illustrates a step of a method for cutting the articular surface.
[0055] 图7-11图解了具有一对长形切割部件的组织改变装置的变体。 [0055] Figures 7-11 illustrates a variant of the tissue cutting member having an elongate pair changing device.
[0056] 图12-14B图解了具有成形的丝的组织改变装置。 [0056] FIG. 12-14B illustrate a forming tissue having a yarn changing device.
[0057] 图15显示了具有一对长形切割部件的组织改变装置的另一变体。 [0057] Figure 15 shows another variant having an elongated tissue cutting member of the pair changing means.
[0058] 图16A-18D图解了具有隔离件的组织改变装置。 [0058] FIGS. 16A-18D illustrate a spacer member having a tissue changing means.
[0059] 图19A-19B图解了具有U-形横截面的组织改变装置的横档的一个变体。 [0059] FIGS. 19A-19B illustrate a variation of U- shaped cross-section having a tissue rungs changing device.
[0060] 图20A-20B图解了具有U-形横截面的组织改变装置的横档的另一变体。 [0060] FIGS. 20A-20B illustrate a further variant of tissue having a U- shaped cross section changing device of the rung.
[0061] 图21A-29图解了本文所述的切割装置和切割装置区域的其它变体。 [0061] FIGS. 21A-29 illustrate a cutting apparatus described herein, and other variants of the cutting device region.
[0062] 图30A图解了包括2个锯骨元件的小关节改变装置的一个变体的横截面。 [0062] FIG 30A illustrates a bone saw includes two facet joint elements to change the cross section of a variant of the apparatus.
[0063] 图30B图解了具有可断裂的隔离件的装置的一部分的横截面。 [0063] FIG 30B illustrates a cross section of the spacer means having a breakable part of.
[0064] 图30C显示了构造成执行椎骨关节面切除术的小关节改变装置的一个变体的俯视图。 [0064] FIG 30C shows a vertebral articular surface configured to perform resection of a plan view of a facet joint variant device is changed.
[0065] 图31A-31E图解了关节治疗装置的变体。 [0065] FIGS. 31A-31E illustrate a variant of the joint treatment device. 在图31A中，所述治疗装置包括前和后关节摩擦表面（articulating surface)，其可以横跨关节表面拉动，以使它们粗糙不平；图31B-31D显示了关节治疗装置的不同横截面，图31E图解了关节治疗装置的另一变体。 In FIG 31A, the treatment device comprises a front and a rear joint friction surface (articulating surface), which can be pulled across the articular surface to make them rough; FIGS. 31B-31D show a cross-section of the joint of different treatment device, FIG. 31E illustrates another variant of the joint treatment device. 这些关节治疗装置中的任一个可以是小关节治疗装置。 The apparatus of any of these joints may be a small joint therapeutic treatment device.
[0066] 图32图解了包括上关节突和下关节突的小关节。 [0066] FIG 32 illustrates a projection comprising upper and lower facet articular facet joint.
[0067] 图33-35图解了所述组织改变装置的的多个变体。 [0067] Figures 33-35 illustrate a variant of the plurality of tissue modification device.
[0068] 图36图解了所述扩展机构的一个变体。 [0068] FIG. 36 illustrates a variant of the extension mechanism.
[0069] 图37-41D图解了所述扩展机构的其它变体。 [0069] FIG 37-41D illustrate other variants of the extension mechanism.
[0070] 图42图解了具有所述罩的组织改变装置的一个变体。 [0070] FIG. 42 illustrates a variant of the changing means having a tissue cover.
[0071] 图43图解了所述的用于改变组织的装置和方法的另一变体。 [0071] FIG. 43 illustrates another variant of a method and apparatus for changing the tissue.
[0072] 图44图解了本文所述的递送装置。 [0072] FIG. 44 illustrates a delivery device as described herein.
[0073] 本文描述了用于切割脊椎组织，诸如骨和/或软组织，尤其是背柱中的脊椎骨的装置、系统和方法，其中使用柔性切割元件，所述柔性切割元件可以围绕骨穿过。 [0073] Described herein are for cutting spinal tissue, such as bone and / or soft tissue, especially a device, system and method for the dorsal column of the spine, where the use of a flexible cutting element, said flexible cutting element can pass around the bone. 在一些实施方案中，这些装置、方法和系统可以用于在组织中切割2个基本上平行的切口，不需要在切割之间取出切割元件。 In some embodiments, the devices, methods and systems may be used in two substantially parallel cut incision in tissue, it does not need to remove the cutting element between the cutting. 本文所述的方法、装置和系统可以用作脊椎外科手术的一部分，所述脊椎外科手术涉及脊椎骨或关节的完全或部分去除，诸如椎板切除术、椎板切开术、椎骨关节面切除术、椎弓根切除术等。 The methods described herein, apparatus and system for spinal surgery may be used as part of a spinal surgery involving complete or partial removal of the joint or the vertebra, such as laminectomy, laminotomy, resection of vertebral articular surface pedicle resection and so on.
[0074] 图1A-1D图解了可以用作所述切割骨的系统的一部分的不同元件。 [0074] Figures 1A-1D illustrate different elements may be used as part of the bone cutting system. 图IA显示了导丝100，其适合联接至另一装置的远端端部，使得使用导丝可以拉动装置就位。 FIG IA shows a guidewire 100, which is adapted to be coupled to a distal end portion of another device, such that the guidewire may pull the device into place. 导丝的远端端部101可以是尖锐的，且近端端部可以包括联接关节102 (例如，球或其它膨大的区域， 其可以被联接部件抓住）。 The distal end of the guidewire 101 may be sharp and may include a proximal end 102 coupled to a joint (e.g., a ball or other enlargement of the area which can be gripped by the coupling member).
[0075] 图IB显示了长形切割部件的一个变体，诸如切割丝103，其具有用于切割诸如软组织（例如韧带）和/或骨等组织的磨蚀表面。 [0075] FIG IB shows a variant of the elongate cutting member, such as cutting wire 103, having a cut tissue such as soft abrasive surface (e.g., ligament) tissue and / or bone. 这样的锯丝（例如，传统的季格利锯）可以适合与导丝一起使用。 Such a wire (e.g., a conventional quaternary saw Gurley) can be adapted for use with a guidewire. 例如，锯的远端端部可以包括导丝联接器104。 For example, the distal end portion of the saw may include a guidewire coupler 104. 在一些变体中，所述丝是薄的或扁平的。 In some variants, the wire is thin or flat. 可以使用任意适当的锯或切割元件，包括通过往复运动或通过施加能量来切割的那些。 You may use any suitable saw or cutting elements, including those that reciprocates or cut by application of energy.
[0076] 图IC图解了柔性条带形神经定位装置105的一个变体。 [0076] FIG IC illustrates a flexible strip-shaped variant of the positioning device 105 nerve. 该装置的远端端部106 是基本上扁平的（从该图不明显），且具有扁平侧面，所述侧面具有沿着表面的一个或多个电极107，用于刺激神经或神经组织（如果附近存在的话）。 The distal end of the device 106 is substantially flat (not obvious from the FIG.), And has a flat side, a side surface 107 having, for stimulating a nerve or neural tissue along the surface of the one or more electrodes (if it exists in the vicinity).
[0077] 图ID图解了骨锯装置的另一变体，所述装置具有2个平行的切割丝108，它们被予页定的距离(例如，4mm、5mm、6mm、7mm、8mm、9mm、10mm、11mm、12mm、13mm、14mm、15mm、16mm、 17mm、18mm等）隔开。 [0077] FIG ID illustrates another variant of a bone saw device, said device having two parallel cutting wire 108, which are predetermined page predetermined distance (e.g., 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, etc.) are separated. 装置的远端端部可以构造成，用于联接导丝100。 The distal end of the device may be configured, for coupling the guidewire 100. 或者，所述装置可以具有在该装置的远端端部处的整体柔性引导区域109，使得该装置不需要任何额外的导丝/联接器。 Alternatively, the device may have the entire region of the flexible distal end of the guide of the device 109, so that the device does not require any additional guidewire / coupler. 例如，显示了具有弯曲形状的柔性引导区域109，以证实柔性引导区域109的至少一部分可以是柔性的。 For example, the flexible display having a curved shape guide area 109 to confirm that at least a part of the flexible guide area 109 may be flexible. 远端部分优选地在至少一个方向是柔性的，使得它可以围绕靶组织缠绕，同时具有足够的柱强度（column strength)，使得远端端部可以无压曲地穿透组织。 The distal end portion is preferably at least one direction is flexible, so that it can be wound around the target tissue, while having sufficient column strength (column strength), so that the distal end can penetrate tissue without buckling manner. 在一些实施方案中，远端端部可以具有尖锐的远端尖部，其构造成穿透和/或刺穿组织。 In some embodiments, the distal end portion may have a sharp distal tip configured to penetrate and / or puncture tissue. 在不同的实施方案中，柔性引导区域109可以具有一个或多个圆形的、卵圆形的、椭圆形的、扁平的、拱形扁平的、矩形的、正方形的、三角形的、对称的或不对称的横截面形状。 In various embodiments, the flexible region 109 may have a guide or a plurality of circular, oval, elliptical, flat, arched flat, rectangular, square, triangular, symmetric or asymmetrical cross-sectional shape. 远端柔性引导区域109可以是逐渐变细的，以促进它进入或穿过狭小的间隙，以及穿过患者皮肤上的小切口。 The distal region of the flexible boot 109 may be tapered to facilitate it into or through the narrow gap, and through a small incision in the patient's skin. 远端柔性引导区域109可以足够长，穿过患者上的第一切口，在靶组织和非靶组织之间延伸，并从患者上的第二切口出来。 The flexible distal region 109 may be long enough to guide through the first incision in the patient, extending between the non-target tissue and the target tissue, and the second cut out on the patient. 在一些实施方案中，远端端部可以具有大于或等于3英寸的长度，使得它可以在刺激区域的近端端部附近从患者伸出，在这里它可以被使用者和/或远端手柄抓紧。 In some embodiments, the distal end portion may have a length greater than or equal to 3 inches, such that it can extend from the proximal portion in the vicinity of the patient stimulation zone, where it can be user and / or the distal end of handle pay close attention. 在一些替代性的实施方案中，远端端部可以具有大于或等于10英寸的长度，而在一些其它替代性的实施方案中，远端端部可以具有大于或等于16 英寸的长度。 In some alternative embodiments, the distal end portion may have a length greater than or equal to 10 inches, while in other alternative embodiments, the distal end portion may have a length greater than or equal to 16 inches. 或者，远端柔性引导区域109可以足够长，穿过第一切口，在靶组织和非靶组织之间延伸，到达患者内的锚定位置。 Alternatively, the distal region of the flexible boot 109 may be long enough, through the first slit, extending between the target and non-target tissue, reaches the anchor position within the patient.
[0078] 本文所述的切割丝108可以是切割丝的几种变体之一。 [0078] As used herein the cutting wire 108 may be one of several variants of the cutting wire. 在一些实施方案中，切割丝可以具有例如在5-50/1000英寸范围内的外径。 In some embodiments, the cutting wire may have an outer diameter of, for example, in 5-50 / 1000 of an inch. 单条线锯可以包括多条丝，所述丝以不同的螺距彼此缠绕。 The wire saw can include a single plurality of filaments, said filaments entangled with each other at different pitches. 如图2所示，具有第一直径的丝202可以围绕具有第二直径的丝201 缠绕。 2, the wire 202 having a first diameter may be wound around the wire 201 having a second diameter. 如所示的，第一直径可以小于第二直径。 As shown, the first diameter may be smaller than the second diameter. 图2图解了季格利切割丝的一个实施例。 Figure 2 illustrates a quarter Gurley cutting wire embodiments. 或者，如图3A-3D所示，组织改变装置的切割丝可以是几个替代实施方案之一。 Alternatively, as shown in FIG. 3A-3D, changing tissue cutting wire apparatus may be one of several alternative embodiments. 例如，如图3A所示，切割丝可以是常规季格利丝的第二实施方案。 For example, as shown in FIG. 3A, the cutting wire may be a second embodiment of a conventional quarter Geli Si. 季格利丝通常由围绕具有第二直径的第二丝缠绕的具有第一直径的第一丝制成。 Quaternary Geli Si generally has a first wire made of a first diameter of a wire wound around a second having a second diameter. 通常，第二直径大于第一直径，或者，它们可以具有基本上相同的直径，如图3A所示。 Typically, the second diameter greater than the first diameter, or they may have substantially the same diameter, shown in Figure 3A. 在一些实施方案中，第一组第一丝和第二丝可以围绕第二组第一丝和第二丝缠绕。 Embodiment] In some embodiments, a first set of first filaments and second filaments may be wound around a second set of first filaments and second filaments. 或者，如图3B所示，切割丝可以包括单条丝，其被机器加工成包括沿着丝长度的螺旋形或螺旋状切割边缘。 Alternatively, 3B, may comprise a single cutting wire filaments, which is machined to include a length of wire along a spiral or helical cutting edges. 通过沿着丝的长度切割螺旋状或螺旋形沟，可以机械加工该丝。 By cutting a spiral groove or spiral along the length of the wire, the wire can be machined. 如图3C和3D所示，通过缠绕丝束，可以形成切割丝。 Shown in Figure 3C and 3D, by winding strands, cut wire may be formed. 例如，如图3D 的横截面所示，切割丝可以包括3x3构造。 For example, the cross-section shown in FIG. 3D, may include a cutting wire 3x3 configuration. 在该实施方案中，3条丝首先围绕彼此缠绕，以建立第一束丝。 In this embodiment, the first wire 3 is wound around each other to establish a first beam filament. 然后，再使3组这样的3丝束围绕彼此缠绕。 Then, three groups such that the strands 3 wound around each other. 如图3C的横截面所示，不是在开始将3条丝缠绕在一起，而是可以将6条丝缠绕在一起，以建立丝束，然后可以将3组6丝束缠绕在一起，以形成3x6构型。 Shown, not in the start winding the yarn cross-section 3 in FIG. 3C together, but the wire 6 may be wound together, in order to establish a tow, can then be wound together tows 6 3 group, to form a 3x6 configuration. 可以像可形成7丝组、但是留出一条丝的空位一样，形成每个6丝组。 7 may be formed like fiber group, but leaving a vacancy as wire, wire 6 forming each group.
[0079] 如图4所示，组织改变装置400包括组织改变部分401、远端端部402和近端端部403。 [0079] As shown, the tissue modification device 400 includes a tissue 4 changing portion 401, a distal end 402 and proximal end 403. 组织改变部分可以包括线锯，其构造成切穿骨和/或软组织。 Tissue changing section may include a wire saw, which is configured to cut through bone and / or soft tissue. 远端端部402可以包括导丝联接器。 The distal end portion of guidewire 402 may include a coupler. 近端端部403可以具有比柔性组织改变区域401更高的刚性。 The proximal portion 403 may have a greater change than the flexible region 401 of rigid tissue. 近端端部可以联接至近端手柄上，所述手柄用于抓紧、定位组织改变装置和/或使其往复运动。 It may be coupled to the proximal end of the proximal end of a handle for grasping, positioning tissue modification device and / or to reciprocate it.
[0080] 在操作中，上述装置可以用作切割骨的系统的一部分，如图5-6B所示。 [0080] In operation, the apparatus may be used as part of a bone cutting system, as shown in FIG. 5-6B. 在该实施例中，从侧面切割关节面，这可以用作例如TLIF手术的一部分。 In this embodiment, the articular surface of the lateral piercer, which may be used as part of, for example, TLIF procedure. 图5显示了该方法的概要。 Figure 5 shows an overview of the process. 在该实施例中，先后制作2个穿过骨的切口。 In this embodiment, it has produced two incisions through the bone. 为了在该手术中根据需要切割小关节，首先围绕/抵靠着要切割的上关节突（SAP) 500，部分地定位导丝。 In order to cut the required facet joint surgery, first around / to be cut against the articular process (SAP) 500, partially positioned guidewire. 可以使用一个或多个探针或插管来定位导丝，使得导丝从第一位置（A)侧向进入，穿过孔并绕过SAP 500，在第二位置(A'）离开脊柱（并离开患者）。 One or more probes may be used to position the cannula or guide wire, such that the guide wire from a first position (A) into the side, through the hole and around SAP 500, a second position (A ') away from the spine ( and away from the patient). 一旦定位好导丝，可以用它拉入神经定位装置，以证实神经(脊神经或神经根）没有在要切割的骨和导丝路径之间。 Once positioned guidewire good, it can be pulled into the nerve locating means to confirm no difference between nerve (nerve or spinal nerve root) in the bone to be cut and the guide wire path. 确认神经没有在骨和路径之间以后，可以拉动切割元件（例如，线锯1B)就位，使得线锯的远端端部和近端端部两者离开患者，并可以向上牵拉（以向后的方向）并在侧向做往复运动，以切割在图5中用虚线501指示的SAP。 After the nerve is not confirmed between the bone and the path, the cutting element may be pulled (e.g., wire saw 1B) in place, so that both the distal end and a proximal end of the wire saw away from the patient, and can be pulled upward (in rearward direction), and reciprocates in the lateral direction, to cut SAP dashed line 501 in FIG. 5 indicated.
[0081] 一旦已经用锯切掉SAP，然后可以定位锯用于第二次切割，穿过椎板。 [0081] Once it has been sawn off by SAP, it may then be positioned for a second saw cutting through the lamina. 任选地，在这次切割之前，和在线锯移动到该位置之前，通过用骨钳或其它装置切刻或咬下一部分椎板502，可以准备椎板（例如形成椎板切开术）。 Before Optionally, prior to the cutting, the saw line and moved to the position, by treatment with a bone forceps or other device or bite notching part 502 of the lamina, the lamina may be prepared (for example, a laminotomy). 例如，在图5中，画虚线的区域显示了可以咬掉以在椎板中形成部分窗的区域502。 For example, in Figure 5, the broken line drawing shows the area to be bitten off portion of the window region 502 is formed in the lamina. 这样做以后，切割元件（线锯）向头侧方向（图5的向下方向）运动，使得丝的端部在向头侧方向延伸（并跨过中央的脊椎轴）。 By doing so, the cutting element (wire saw) (downward direction in FIG. 5) to the head movement direction, so that the end portion of the wire extends in the cephalad direction (and across the center axis of the spine). 因而，锯B的一个末端存在于在椎板中形成的刻痕或窗中，另一末端B'沿着孔运动。 Thus, one end of the saw or B present in the score window formed in the vertebral plate, the other end B 'movement along the bore. 如果需要，可以再次使用神经定位装置来确认从该位置不会切到神经，例如，通过向近端收缩导丝、取出切割元件和连接神经定位装置。 If desired, the positioning device can be used again to confirm the nerve from a position without cutting the nerve, e.g., by shrinking the guide wire proximally, remove the cutting element and the positioning means connected nerves. 最后，可以使切割元件往复运动，以沿着虚线503切穿椎板的突出区域（pars region)。 Finally, the cutting element may be reciprocated to cut through lamina protruding region along the dashed line 503 (pars region). 此后，可以取出骨的切掉部分，并根据需要进行其它手术。 Thereafter, the cut portion of bone can be removed, and other procedures as necessary.
[0082] 在包括2条平行丝的实施方案中，可以在单个步骤中切割关节面或靶组织缝。 [0082] In the two filament embodiment includes parallel, the articular surface may be cut or slit target tissue in a single step. 例如，为了进行椎骨关节面切除术，可以将装置刚好布置在尾根的向头侧。 For example, in order to perform resection of the articular surface of the vertebrae, the device may be arranged just cephalad to the base of the tail. 可以使平行的丝保持希望的宽度，或可以扩展所述丝至希望的宽度。 It can be made parallel to the wire holding desired width, or may extend the filaments to a desired width. 希望的宽度可以在6mm-15mm范围内，取决于例如要在椎骨之间插入的椎体间装置。 Desired width may be in the range of 6mm-15mm, depending, for example to be inserted between the vertebrae means between the vertebral bodies. 在一些变体中，可以扩展头侧丝至希望的宽度。 In some variations, the head-side wire to be extended the width desired. 然后可以使装置跨过要切割的组织往复运动，以去除小关节宽度的至少一部分。 The device can then be cut across the tissue to be reciprocated to remove at least a portion of the width of the facet joint. 通过交替地牵拉装置的近端端部（例如近端手柄）和牵拉装置的远端端部（例如远端手柄和/或导丝），可以使所述装置往复运动。 The distal end portion (e.g., the distal end of the handle and / or guide wire) proximal end (e.g., the proximal end of the handle) by alternately pulling means and pulling means, the apparatus can be made to reciprocate. 在牵拉一个末端的同时，也牵拉另一末端，以维持跨装置的张力。 In the drawing one end, while also pulling the other end, in order to maintain tension across the device.
[0083] 图6A和6B图解了上述步骤的备选视图。 [0083] FIGS. 6A and 6B illustrate an alternate view of the above-described steps. 例如，图6A显示了下述步骤：切穿SAP 600(虚线601)，咬掉椎板/在椎板中形成窗602，在尾侧方向（箭头603)移动切割元件，并切割突出物（pars)(虚线604)。 For example, FIG. 6A shows the step of: cutting through the SAP 600 (dashed line 601), bite lamina / window 602 is formed in the lamina, the caudal direction (arrow 603) to move the cutting element and the cutting projection (Pars ) (dashed line 604). 图6B显示了脊柱的横截面视图，其指示SAP的切割。 6B shows a cross-sectional view of the spinal column, which indicates SAP cutting. 如所示的，穿过孔并围绕SAP(未显示）定位切割丝600。 As shown, through the holes and around the SAP (not shown) of cutting wire 600 is positioned. 使丝往复运动，并在箭头的方向牵拉， 以切穿SAP。 Reciprocates the yarn and pulling in the direction of the arrows, to cut through SAP.
[0084] 如上所述，在本文所述的任意小关节手术中，可以切掉关节面的全部或一部分(例如，上和/或下棘突）。 [0084] As described above, in any facet joint surgery described herein, all or a portion may be cut out of the articular surface (e.g., upper and / or lower spinous process). 例如，融合或准备小关节的手术可以包括椎骨关节面切除术，尤其是TLIF(穿孔腰椎椎体间融合术）手术。 For example, to prepare fusion surgery or vertebral facet joint may include a resection of the articular surface, in particular TLIF (between perforations lumbar interbody fusion) operation. 所述手术可以包括小关节治疗装置，其构造成锯穿骨。 The surgical treatment apparatus may include a facet joint, which is configured to cut through bone. 例如，所述装置可以包括一个或多个缆索型锯，所述锯包括远端端部，其构造成联接至如上所述的牵拉丝。 For example, the apparatus may comprise one or more cables type saw, said saw comprising a distal end configured to be coupled to a pull wire described above. 如所述的，可以使用一个或多个探针来将牵拉丝置于小关节下。 As described, one or more probes may be used to pull wire placed under the facet joint. 然后可以在双手控制下，牵拉小关节改变装置。 May then be under control of hands, facet joint puller changing means. 向背侧牵拉小关节改变装置（例如，通过远端/近端往复运动），会导致整个小关节的去除。 Changing means to pull back side facet joint (e.g., through a distal / proximal reciprocation), it will lead to the removal of the entire facet joint. 该方法可以比现有方法更快，所述现有方法包括用骨钳型装置缓慢地啃咬。 This method can be faster than existing methods, the conventional method comprises a bone clamp means gradually bite.
[0085] 具有2个长形切割部件的组织改变装置 [0085] having two elongated tissue cutting member changing means
[0086] 在本文所述的用于在患者中切割组织的装置、系统和方法的一些实施方案中，装置的组织改变区域包括一对柔性长形切割部件，它们沿着组织改变区域的长度延伸。 [0086] In some embodiments of the apparatus described herein for cutting tissue in a patient, the system and method, the tissue area changing means comprises a pair of flexible elongate cutting member, which extends the length of the area along tissue changes . 每个长形切割部件可以构造成，在组织中切割单独的槽至大于切割部件厚度的深度。 Each elongate member may be configured to cut, cut a single groove in the tissue to a depth greater than the thickness of the cutting member.
[0087] 在第一实施方案中，所述组织改变装置（例如，骨锯）可以包括直接地联接至缆索上的切割边缘，如图7所示，所述缆索701可以包括切割元件703，诸如珠子、刀片、丝或其它合适的切割元件。 [0087] In a first embodiment, the tissue modification device (e.g., a bone saw) may comprise a directly coupled to the cable on the cutting edge, shown in Figure 7, the cable 701 may include a cutting element 703, such as beads, blade, wire or other suitable cutting element. 在一些实施方案中，所述切割元件可以固定在丝上，或通过其它合适的方法进行连接。 In some embodiments, the cutting element may be fixed to the wire, or connected by other suitable methods. 使用能量，诸如热或射频能量，可以使切割缆索切割组织。 Using energy, such as heat or radio frequency energy, the cable may be cut the cutting tissue. 所述能量的作用可以是烘干和/或收缩组织，而不是切割它。 The effect of energy may be dried and / or contraction of tissue, rather than cutting it. 如图7所示，装置的一部分可以包括切割缆索701，而装置的另一部分包括隔离件或横档702，它们穿在缆索上（在隔离件上具有或没有切割边缘）。 , A portion of the device shown in Figure 7 may include a cutting cable 701, while another portion of the apparatus includes a spacer member or rail 702, through which (with or without a cutting edge on a separator) on the cable. 切割缆索和穿有隔离件的缆索可以是相同的或不同的缆索。 And cutting the cable with a cable through the spacer may be the same or different cables.
[0088] 如图8所示，组织改变装置800包括组织改变部分801、远端端部802和近端端部803。 [0088] As shown, the tissue modification device 800 includes a tissue 8 changing portion 801, a distal end 802 and proximal end 803. 组织改变部分可以包括2个平行的线锯805，其构造成切穿骨和/或软组织。 Tissue changing section may include two parallel wire saw 805, which is configured to cut through bone and / or soft tissue. 远端端部802可以包括导丝联接器。 The distal end portion of guidewire 802 may include a coupler. 近端端部803可以具有比柔性组织改变区域801更高的刚性。 The proximal portion 803 may have an area greater than 801 to change the rigidity of the flexible tissue. 近端端部可以联接至近端手柄上，所述手柄用于抓紧、定位组织改变装置和/或使其往复运动。 It may be coupled to the proximal end of the proximal end of a handle for grasping, positioning tissue modification device and / or to reciprocate it. 近端端部803可以包括近端连接件元件804，其将近端端部803联接至平行的线锯805。 Proximal end 803 may include a proximal end of the wire saw 805 connector element 804, which is nearly to the end to end portion 803 is coupled in parallel. 在一些实施方案中，所述组织改变部分801可以包括单条线锯，其在一个末端联接至远端端部，贯穿近端连接件元件804，并在第二末端处联接至远端端部。 In some embodiments, the tissue modification portion 801 may comprise a single wire saw, which is coupled to a distal end portion at one end, through the proximal end of the connector element 804, and coupled to the distal end portion at the second end. 切割丝可以构造成，穿过近端连接件元件滑动，且可相对于近端端部803运动。 Cutting wire may be configured to slide through the proximal connector element and movable relative to the proximal end 803 movement. 图9显示了定位在脊柱内的组织改变装置。 Figure 9 shows the tissue modification device is positioned within the spinal column. 如所示的，被围绕着定位装置的脊柱的表面可以是凹凸不平的。 As shown, the surface of the spinal column is surrounded by positioning means may be uneven. 在一些情况下，所述装置不会以平衡的方式接触脊柱表面，或者不会紧靠在要切割的表面上。 In some cases, the device will not balance the contact surface of the spine, or without abutting on the surface to be cut. 如图9 和10所示，近端连接件元件（分别标记为904和1004)确保切割丝可以穿过连接件元件滑动和重新定位，使得切割丝的平行部分均可紧靠在要切割的组织上。 9 and 10, the proximal end of the connector elements (904 and 1004 are labeled) ensure that the cutting element can pass through the wire and the connecting member slidably repositioned so that parallel portions of the cutting wire can be cut in the tissue against on.
[0089] 在一个替代实施方案中，如图11所示，组织改变装置可以包括滑轮1101。 [0089] In an alternative embodiment, shown in Figure 11, the tissue modification device 1101 may comprise a pulley. 所述滑轮联接至切割丝1102，且可以定位在组织改变装置的近端端部和/或远端端部。 The pulley 1102 is coupled to the cutting wire, and may be positioned at the proximal and / or distal end of the tissue modification device. 所述滑轮可以构造成重新定位切割丝，使得切割丝的平行部分均可以紧靠在要切割的组织上。 The pulley may be configured to reposition the cutting wire, so that the parallel portion of the cutting wire can be abutted against the tissue to be cut.
[0090] 如图12所示，组织改变装置1200包括组织改变部分1201、远端端部1202和近端端部1203。 [0090] 12, 1200 includes a tissue organization changing means changing portion 1201, distal end 1202 and proximal end 1203. 所述组织改变部分可以包括2个平行的线锯1205，它们构造成切穿骨和/或软组织。 The tissue may comprise changing section 2 parallel wire saw 1205 that are configured to cut through bone and / or soft tissue. 远端端部1202可以包括导丝联接器。 The distal end portion 1202 may include a guidewire coupling. 所述导丝联接器可以联接至导丝（其可以联接至远端手柄），且可以用于抓紧、定位组织改变装置和/或使其往复运动。 The guide wire may be coupled to the coupling wire (which may be coupled to the distal end of the handle), and may be used for grasping, positioning tissue modification device and / or to reciprocate it. 近端端部1203 可以具有比柔性组织改变区域1201更高的刚性。 1203 may have a proximal end portion 1201 changes the region higher than the flexible organization rigidity. 近端端部可以联接至近端手柄上，所述手柄用于抓紧、定位组织改变装置和/或使其往复运动。 It may be coupled to the proximal end of the proximal end of a handle for grasping, positioning tissue modification device and / or to reciprocate it. 近端端部1203可以包括近端连接件元件1204A，其将近端端部1203联接至平行的线锯，远端端部1202可以包括远端连接件元件1204B，其将远端端部1202联接至平行的线锯。 The proximal end 1203 may include a wire saw proximal connector element 1204A, which nearly end to end 1203 is coupled to the parallel portion, the distal end of the distal end portion 1202 may include a connector element 1204B, which is coupled to the distal end portion 1202 a line parallel to the saw. 在一些实施方案中，所述组织改变部分1201可以包括单条线锯，其贯穿近端连接件元件1204A和远端连接件元件1204B。 In some embodiments, the tissue modification section 1201 may comprise a single wire saw, through which the proximal and distal connector member connector elements 1204A 1204B. 切割丝可以构造成，穿过连接件元件滑动。 Cutting wire may be configured to slide through the connector element. 如所示的，连接件元件构造成保持切割丝彼此分开。 The construction elements, connecting member shown separated from each other to hold the cutting wire. 在一些变体中，使所述丝保持大于希望的最小宽度的间隔距离，使得如果在装置的定位和/ 或往复运动过程中，切割丝1205确实发生一些接近（例如，由于脊柱的几何学和/或解剖学），所述丝仍将至少间隔希望的最小宽度。 In some variations, the filament separation distance is greater than a desired minimum width, such that if the positioning means and / or reciprocation, 1205 something close cutting wire does occur (e.g., due to the geometry of the spine and / or anatomical), said filaments remain spaced at least a minimum desired width. 在一些变体中，所述连接件元件由柔性材料或形状记忆材料（诸如镍钛记忆合金）制成。 In some variations, the connector element is made of a flexible material or a shape memory material (such as Nitinol). 在该变体中，如果连接件受到压迫，使得连接件的腿部分彼此更近，所述连接件腿会被偏压分开，并恢复它们的最初构型。 In this variant, if the connecting member is pressed by such connecting member leg portions closer to each other, said connecting member legs will be biased apart, and recover their original configuration. [0091 ] 在一个替代变体中，如图13A和13B所示，组织改变装置1300包括组织改变部分1301、远端端部1302和近端端部1303。 [0091] In an alternative variant, 13A and 13B, the tissue modification device 1300 comprises a tissue change portion 1301, distal end 1302 and proximal end 1303. 所述组织改变部分可以包括2个平行的线锯，它们构造成切穿骨和/或软组织。 The tissue may comprise changing section 2 parallel wire saw, which is configured to cut through bone and / or soft tissue. 远端端部1302可以包括导丝联接器。 The distal end portion 1302 may include a guidewire coupling. 所述导丝联接器可以联接至导丝（其可以联接至远端手柄），且可以用于抓紧、定位组织改变装置和/或使其往复运动。 The guide wire may be coupled to the coupling wire (which may be coupled to the distal end of the handle), and may be used for grasping, positioning tissue modification device and / or to reciprocate it. 近端端部1303可以具有比柔性组织改变区域1301更高的刚性。 1303 may have a proximal end portion 1301 changes the region higher than the flexible organization rigidity. 近端端部可以联接至近端手柄上，所述手柄用于抓紧、定位组织改变装置和/或使其往复运动。 It may be coupled to the proximal end of the proximal end of a handle for grasping, positioning tissue modification device and / or to reciprocate it. 在一些变体中，切割丝由柔性材料或形状记忆材料（诸如镍钛记忆合金）制成。 In some variations, the cutting wire is made of a flexible material or shape memory material (such as Nitinol). 如图13A所示，处于它们的平衡或偏压构型的丝保持相距第一距离A。 13A, it is in their balance or bias configuration wire holding first distance A. 距离A比希望的最小宽度更宽。 A minimum width wider than the desired distance. 在该变体中，如果切割丝受到压迫，使得切割丝彼此更近，切割丝会被偏压分开，并将恢复它们的最初的、更宽的构型。 In this variant, if the cutting wire are oppressed, closer to each other such that the cutting wire, cutting wire are biased apart, and restore their original, wider configuration. 如所述的，所述丝保持大于希望的最小宽度的间隔距离，使得如果确实发生一些接近，所述丝仍将至少间隔希望的最小宽度。 As said, the minimum wire width greater than holding a desired spacing distance, if it occurs that some of the close spacing of the wire will at least a minimum desired width. 在操作中，可以将导丝联接至远端端部1302，使得通过导丝和装置的近端端部，可以交替牵拉组织改变装置。 In operation, the guide wire may be coupled to the distal end portion 1302, such that the proximal end of the guidewire and apparatus, may be alternately pulling tissue modification device. 如图13B所示，随着装置被牵拉和往复运动，所述丝可能随着组织改变部分1301被拉长而向彼此接近，到达宽度B。 13B, as the device is pulled and reciprocates, the wire may change as the tissue is elongated portion 1301 to close to each other and reach a width B. 宽度B优选地至少像希望的最小宽度一样宽。 As wide as the minimum width B is preferably at least as desired. 在一些变体中，所述装置可以另外包括长度限制元件1304。 In some variations, the device may further comprise length limiting element 1304. 如图13A所示，所述长度限制元件是柔性的，且不会被拉紧。 As shown in FIG. 13A, the flexible element is a length limit, and is not tensioned. 在图13B中，随着装置置被牵拉和往复运动，组织改变部分1301仅被拉长至长度限制元件1304 的长度。 In FIG 13B, as the device is pulled and set reciprocated tissue changing section 1301 is only stretched to a length of the restriction element 1304. 长度限制元件1304构造成，使得组织改变部分1301不会被拉长到使宽度B过小。 The length of the limiting element 1304 is configured so that the tissue is not changing section 1301 to a stretched width B is too small. 宽度B优选地至少像希望的最小宽度一样宽。 As wide as the minimum width B is preferably at least as desired. 或者，在一些变体中，宽度C优选地至少像希望的最小宽度一样宽。 Alternatively, in some variations, the width C is preferably at least as wide as the minimum width desired.
[0092] 在一些实施方案中，如图14A和14B所示，切割丝可以具有这样的横截面，其构造成在正交方向限制柔性，并从而限制丝的接近。 [0092] In some embodiments, as shown in FIG 14A and 14B, the cutting wire may have a cross-section, configured to limit flexibility in the orthogonal direction, and thus limiting the wire close. 如图14B所示，更宽的基本上矩形的横截面对显示的正交载荷更不敏感。 14B, a substantially wider face of rectangular cross section perpendicular to the display less sensitive to load.
[0093] 具有隔离件的组织改变装置 [0093] The spacer member having a tissue changing means
[0094] 在一些实施方案中，切割装置的组织改变区域包括一对沿着组织改变区域的长度延伸的柔性长形切割部件，且也包括隔离件。 [0094] In some embodiments, the tissue cutting device comprises a length change region extending along a region of tissue changes of the flexible elongate cutting member pair and also including spacers. 每个长形切割部件可以构造成在组织中切割分离的槽的深度大于切割部件的厚度。 Each elongate member may be configured to cut the thickness of the cutting depth in the tissue slot is greater than the separation of the cutting member. 隔离件通常可以跨2个切割部件之间的宽度，使它们保持相距某种预定的（或可调节的）距离。 Spacer member generally across the width between the two cutting means, keeping them apart some predetermined (or adjustable) distance. 由于隔离件通常不会切割组织，它们可以构造成，使得它们基本上不会抑制切割丝或切割边缘对组织的切割。 Since the spacer does not usually cut tissue, they can be configured such that they do not substantially inhibit the cutting wire to a cutting edge or cutting tissue. 隔离件可以形成合适的尺寸，并构造成以如下两种模式之一操作：第一模式，其中所述隔离件被联接至切割部件， 使得其保持2个切割部件中的每一个的一部分彼此相距一定距离；和第二模式，其中所述隔离件的至少一部分移动离开切割部件，以允许切割部件更深入地切入组织。 Spacer member may be formed of a suitable size, and configured to operate in one of two modes: a first mode wherein said spacer member is coupled to the cutting member, such that a portion of the holding member 2 of each of the cut apart from each other a distance; and a second mode, wherein moving at least a portion of said spacer member away from the cutting element to allow the cutting member to cut deeper tissue.
[0095] 再参照图9，在一些实施方案中，脊柱的凹凸不平的或弯曲的表面可能造成长形切割部件901接近例如弯部的顶点和/或小关节的前部。 [0095] Referring again to FIG. 9, in some embodiments, the uneven surface of the spine or curved cutting may cause the elongate member 901 close e.g. vertex and / or the front portion of the curved portion of the facet joint. 如果丝接近至足够的程度，被装置切割和/或去除的组织的宽度可能不会像特定操作所希望的或需要的那样宽。 If the wire close to a sufficient degree, by the width of the device for cutting and / or removal of tissue specific operation may not be as desired or required as wide. 例如，如果丝彼此太近，它们可能不会围绕小关节切割，也就不可能去掉整个小关节。 For example, if the wire is too close to each other, they may not cut around the small joints, it is impossible to remove the entire facet joint. 在这些情况下， 提供另外包括隔离件的组织改变装置可能是有利的，如下面所详细描述的。 In these cases, further comprising providing a spacer tissue modification device may be advantageous, as described in detail below.
[0096] 图15显示了平行的线锯的另一变体，其中平行的丝1500和1501保持相距最小的距离。 [0096] Figure 15 shows a further variant of parallel wire saw, wherein the parallel wires 1500 and 1501 to maintain a minimum distance apart. 因而，尽管装置是柔性的，希望使切割丝之间的距离（和因而被切掉的骨块的宽度） 保持相距预定的长度。 Thus, although the device is flexible, it is desirable that the distance (and thus the width of the bone cut away) is held between the cutting wire at a predetermined length. 在图15中，一个或多个隔离件1502可以使切割丝保持分开。 In Figure 15, one or more isolation elements 1502 may be kept separate so that the cutting wire. 可以在往复运动过程中去掉隔离件（例如，通过脱离，或通过从装置的一侧分离），或它们可以是可扩展的（但不是非常可压缩的），使得它们可能在扩展的同时允许切割区域咬入骨中。 Spacers can be removed reciprocation (e.g., through the escape, or by separating from the side of the device), or they may be extensible (but not very compressible) so that they may be cut while being expanded to allow regional bite into the bone.
[0097] 图16A-18D图解了组织改变装置1600的一个替代实施方案，其具有一对柔性长形切割部件1601和隔离件1602。 [0097] FIGS. 16A-18D illustrate an alternative embodiment of a tissue modification device 1600, which has a flexible elongated one pair of cutting member 1601 and spacer member 1602. 如图16A所示，组织改变装置包括具有组织改变区域的远端端部和近端端部1605，在一些实施方案中，所述近端端部具有近端手柄1604。 16A, the tissue modification device comprising a distal end and a proximal end portion 1605 has a region of tissue changes, in some embodiments, the proximal portion having a proximal handle 1604. 远端组织改变区域包括一对柔性长形切割部件1601和隔离件1602。 Change region distal tissue cutting member comprises a flexible elongated one pair of spacers 1601 and 1602. 如所示的，导丝联接器1608可以是在组织改变装置的远端端部。 As shown, guidewire 1608 may be coupled to a distal end portion of the tissue of the changing means. 导丝联接器可以构造成连接至导丝（例如，导丝的近端端部），所以在导丝已经固定在装置上以后，通过牵拉导丝，可以至少部分地操纵装置（例如往复运动）。 Coupling the guidewire may be configured to be connected to a guide wire (e.g., a guidewire proximal end), so that after the guide wire has been fixed to the apparatus, by pulling the guide wire may be at least partially actuating device (e.g. a reciprocating motion ). 如图16A所示和如图16B更详细地所示，隔离件1602可以另外包括被动限制器1609，其联接至隔离件的外缘。 As shown in FIG. 16A and 16B shown in FIGS. More specifically, the spacer 1602 may additionally comprises a passive limiter 1609, which is coupled to the outer edge of the spacer. 如所示的，这些限制器的一部分联接至切割部件1601。 As shown, the coupling portion of the cutting member 1601 to the limiter. 这些限制器可用于保持切割丝朝向装置的外缘，和/或防止丝接近。 The limiter means for holding an outer edge toward the cutting wire and / or wire prevents close. 如所示的，限制器可以不排满装置的组织改变区域的整个长度。 As shown, the limiter may not be filled tissue discharge apparatus change the entire length of the region. 这可能是合乎需要的，使得一部分切割丝1601被暴露。 This may be desirable, such that a portion of the cutting wire 1601 is exposed. 在组织改变装置抵靠着组织的最初往复运动过程中，这些暴露的丝可能提供切割作用。 In the initial tissue modification device against the tissue during reciprocation of these filaments may be exposed to provide cutting action. 随着装置被跨着组织前后拉动（即往复运动），切割丝1601的暴露部分开始切穿骨和/或软组织。 As the device is pulled back and forth across the tissue (i.e., reciprocated), the exposed portion 1601 of the cutting wire cutting through the start bone and / or soft tissue. 在一些实施方案中，在装置跨组织往复运动的同时，抵靠着组织“向上”（向患者的背部）牵拉所述装置。 In some embodiments, while the device reciprocates across the tissue, tissue against the "up" (to the patient's back) the pulling means. 由于该向上的压力，切割丝开始切入组织，并在组织中建立槽。 Due to the upward pressure, start cutting wire to cut tissue, and establishing in the tissue slot. 随着在组织中形成最初的槽，切割丝向组织中移动得更深，切割丝最终脱离限制器1609。 With the formation of the first groove, the tissue cutting wire moves deeper into the tissue, the final cutting wire from the limiter 1609. 在一些实施方案中，所述限制器由弹性材料或其它可变形材料制成，使得限制器的上唇（在图17B 中标记为1707)可以变形，以允许切割丝被拉出限制器。 In some embodiments, the stopper is made of elastomeric material or other deformable material, such that the upper lip limiter (labeled as 1707 in FIG. 17B) may be deformed to allow the stopper to be pulled out cutting wire. 或者，切割丝可以切穿或折断限制器的一部分（例如，上唇）。 Alternatively, a portion of the cutting wire can be cut through or break limiter (e.g., upper lip).
[0098] 返回图16A，所述组织改变装置另外包括弹簧1603。 [0098] Back to Figure 16A, the tissue modification device 1603 further comprises a spring. 该弹簧可用于将罩1602联接至组织改变装置的近端端部1605。 The spring 1602 may be used to couple the cover to the proximal end of the tissue modification device 1605. 随着切割丝1601切入组织和隔离件1602离开切割丝， 弹簧1603会伸长，并允许隔离件的近端端部（在图18A-18C中标记为1802)向装置的远端端部运动，使得隔离件的远端端部可以弯曲，并移动离开切割丝1601。 As the cutting wire to cut tissue and spacer member 1601 away from the cutting wire 1602, the spring 1603 will stretch and allow the proximal end of the spacer member (FIGS. 18A-18C labeled as 1802) motion to the distal end of the apparatus, such that the distal end portion of the spacer may be bent, and is moved away from cutting wire 1601. 另外，如图16A所示， 组织改变装置可以任选地包括横档1607。 Further, as shown in FIG 16A tissue modification device may optionally comprise a ledge 1607. 这些横档可以沿着装置长度穿在丝上。 These rungs may be threaded onto the filament along the length of the device. 所述横档可以定位在装置的组织改变区域的远侧和/或近侧。 The rungs may be positioned in the tissue distal region of the device is changed and / or proximally. 在一些实施方案中，所述隔离件可以连接至横档，所述横档定位在组织改变区域的远侧。 In some embodiments, the spacer may be attached to the ledge, said ledge positioned distally of the tissue change region.
[0099] 图17A和17B详细图解了上述的被动限制器1700。 [0099] Figures 17A and 17B illustrate in detail the above passive limiter 1700. 如图17A所示，所述限制器包括上唇部分，所述上唇部分联接至切割丝，并使该切割丝暂时保持就位，与其它切割丝相距一定距离。 As shown in FIG. 17A comprises a limiter upper lip portion, the lip portion is coupled to the cutting wire, and the cutting wire is temporarily held in place, a distance from the other cutting wires. 上唇限定了通道1703，在该通道中可以暂时容纳切割丝。 Upper lip defines a channel 1703, in the channel can be temporarily accommodated cutting wire. 限制器还包括基座部分， 它的的功能是将限制器1700联接至组织改变装置的隔离件。 Limiter further includes a base portion, its function is to change the limiter 1700 is coupled to the tissue of the spacer means. 如图17B所示，限制器的基座部分1702可以限定通道1704。 17B, ​​the base portion 1702 may define a channel stopper 1704. 该通道可以形成合适的尺寸，并构造成接收隔离件的外缘。 The channel may be formed of a suitable size, and is configured to receive the outer edge of the spacer. 如图16B所示，所述隔离件可以包括2个被动限制器，各自联接至隔离件的每个边缘。 16B, the spacer member may comprise two passive limiter, coupled to each of the edges of each spacer member. 在一些实施方案中，所述限制器可以挤出或模铸，然后可以使用粘合剂、紫外线胶、或任意其它合适的联接机构，联接至隔离件上。 In some embodiments, the limiter can be extruded or molded, and then using an adhesive, UV adhesive, or any other suitable coupling mechanism, coupled to the spacer member. 或者，所述限制器可以直接地包裹模制（over-mold)在隔离件上。 Alternatively, the restrictor may be directly wrapped molding (over-mold) on the spacer member.
[0100] 图18A-18D详细图解了组织改变装置的一个实施方案的组件。 [0100] FIGS. 18A-18D illustrate in detail the components of one embodiment of a tissue modification device. 如图18A所示，所述组织改变装置包括隔离件1800和至少一个限制器1801，所述限制器1801联接至所述隔离件的外缘。 18A, the spacer member includes a tissue modification device 1800 and 1801 the at least one restrictor, the restrictor 1801 is coupled to an outer edge of said spacer. 所述隔离件包括远端部分1800和近端部分1802，所述远端部分定位在装置的组织改变区域内，邻近切割丝（在图18B-18D中标记为1803)。 The spacer member includes a distal portion 1800 and a proximal portion 1802, the distal portion is positioned within the change area, adjacent to the cutting wire (labeled 1803 in FIG. 18B-18D) in the tissue of the apparatus. 在该实施方案中，隔离件1800的远端端部固定在装置的远端端部，且近端端部1802经由弹簧可移动地联接至装置的近端端部（在图18C和18D中标记为1808)。 In this embodiment, the distal end portion of the spacer 1800 is fixed to the distal end of the device, and the proximal end portion 1802 is movably coupled to the proximal end (labeled in FIG. 18C and 18D via a spring means 1808). 在一些实施方案中，所述装置的组织改变区域的长度可以在Icm至几英寸的范围内。 In some embodiments, the change in length of the region of tissue means may be in the range of several inches to Icm. 组织改变区域优选地足够长，以例如抵靠着小关节往复运动和切穿小关节。 Tissue change region is preferably sufficiently long, for example, against the facet joint reciprocation and cut through the facet joint. 在一些实施方案中，更长的组织改变区域可以具有增加切割丝的疲劳寿命的额外益处，这归因于跨更长的丝分布切割载荷。 In some embodiments, longer tissue change region may have additional benefit of increasing the fatigue life of the cutting wire, due to the longer cross-wire cutting load distribution. 或者，也希望设计组织改变区域，使得它不会长至使切割丝向彼此接近，并不利地影响装置的有效性。 Alternatively, it is desirable to design altered tissue region, so that it does not grow to the cutting wire close to each other, and adversely affect the effectiveness of the device.
[0101] 如图18B所示，所述装置另外包括切割丝1803。 [0101] As shown in FIG. 18B, the apparatus 1803 further comprises a cutting wire. 如所示的，切割丝（至少最初） 邻近限制器1801定位。 As shown, the cutting wire (at least initially) is positioned adjacent the stopper 1801. 在该实施方案中，所述装置还可以包括朝向装置的远端端部的缆索1804和朝向装置的近端端部的缆索1805。 In this embodiment, the apparatus may further comprise a cable proximal end 1805 of the distal end of the apparatus facing towards the cable and the device 1804. 如所示的，在该实施方案中，切割丝1803和缆索1804和缆索1805都是一条连续的缆索，其从近端端部连接至远端端部，穿过在装置的远端端部处的导丝联接器1806，回到近端端部。 As shown, in this embodiment, the cutting wire cables 1803 and 1804 and the cable 1805 is a continuous cable, which is connected from the proximal end to the distal end portion through the distal end of the device the guide wire coupler 1806, back to the proximal end. 在一些实施方案中，缆索的切割丝部分可以包括刀片或其它合适的切割边缘。 In some embodiments, the cable cutting wire portion may include a blade or other suitable cutting edge. 在一些实施方案中，可以从缆索的非切割部分（1804和1805) 用砂磨出（sand down)切割边缘或以其它方式去除切割边缘。 In some embodiments, the sand can be used (sand down) cutting edges or otherwise remove from the non-cutting portion of the cutting edge (1804 and 1805) of the cable. 或者，缆索1804和缆索1805 可以是联接至切割丝1803的不同缆索或不同材料。 Alternatively, the cable 1804 and cable 1805 may be coupled to the cutting wires of different materials or different cable 1803. 此外，单条连续缆索可以不一路缠绕贯穿装置的远端端部。 Furthermore, a single continuous cable may not penetrate all the way to the distal end of the winding apparatus. 或者，单独的缆索可以穿过装置的远端端部（图18D中的横档1809) 成环，且远端端部可以用单独的联接机构联接至装置的组织改变区域。 Alternatively, a separate cable may pass through the distal end portion (FIG. 18D ledge 1809) of the ring-forming apparatus, and the distal end portion of the device can be coupled to the tissue change region with a separate coupling means. 或者，在装置的远端端部或近端端部中可以不存在缆索。 Alternatively, the cable may not be present at the distal end or the proximal end of the device.
[0102] 如图18C所述，所述装置可以包括近端端部1807和弹簧1808。 [0102] The FIG. 18C, a device may comprise a proximal portion 1807 and the spring 1808. 如上所述，弹簧1808可用于将隔离件1802的近端端部可移动地联接至装置1807的近端端部，使得隔离件可以相对于切割丝1803运动。 As described above, the spring 1808 may be used to the proximal end of the spacer 1802 may be movably coupled to the proximal end portion 1807 of the apparatus, so that the spacer member relative to the cutting wire 1803 movement. 如图18D所示，在一些实施方案中，所述装置可以另外包括远端横档1809和远端横档1810。 As shown in FIG 18D, in some embodiments, the apparatus may further include a distal ledge 1809 and a distal ledge 1810. 这些横档可用于给装置添加结构，同时维持薄度和柔性。 These rungs may be used to add to the structure of the apparatus, while maintaining the thinness and flexibility.
[0103] 在一些实施方案中，如图19A所示，隔离件可以具有“U”形（例如圆形的或正方形拆分的U-形）。 [0103] In some embodiments, as shown in FIG. 19A, the spacer may have a "U" shape (e.g. circular or square-shaped U- resolved). 所述隔离件可以包括2个腿部分1901和基座部分1902。 The spacer member may comprise two leg portions 1901 and base portion 1902. 所述腿部分可以垂直于所述基座部分，或可以以任意其它合适的方式构造。 The leg portion may be perpendicular to the base portion, or may be constructed in any other suitable manner. 所述腿部分可以是基本上直的。 The leg portion may be substantially straight. 或可以具有弯曲的构型。 Or may have a curved configuration. 隔离件可以限定开口1904，缆索1905或其它连接件可以从所述开 The partition may define an opening 1904, 1905, or other cable connectors can start from the
18口中穿过。 18 through the mouth. 在一些实施方案中，所述隔离件可以包括切割边缘1903。 In some embodiments, the spacer 1903 may include a cutting edge. 切割边缘可以联接至隔离件的腿部分，在开口1904的上方。 The cutting edge may be coupled to the leg portion of the spacer member, in the opening 1904 above. 如图19B所示的，U-形隔离件可用于随着切割边缘切穿组织，允许隔离件的腿穿过组织1908，诸如韧带和骨，使得隔离件的基座部分不会抓住组织或以其它方式妨碍组织的切割。 Shown in FIG. 19B, U- shaped spacer member may be used as the cutting edge to cut through tissue, allowing the leg separator 1908 through tissue, such as ligaments and bone, so that the spacer does not base portion or catch tissue otherwise interfere cutting tissue. 如所示的，许多U-形隔离件可以联接至缆索上，以形成改变装置。 As shown, many U- shaped spacer member may be coupled to the cable, to form changing means. 在一些实施方案中，次要隔离件1906可以联接至2个邻近的U-形隔离件之间的缆索上。 In some embodiments, the secondary spacer member 1906 may be coupled to the cable between the two adjacent U- shaped spacer. 次要隔离件1906可以包括切割边缘1907。 Secondary spacer member 1906 may include a cutting edge 1907.
[0104] 在一些实施方案中，所述腿部分可以是柔性的。 [0104] In some embodiments, the leg portion may be flexible. 如图20A-B所示，U-形隔离件的腿部分2001可以由可扩展的或可伸展的材料制成，使得随着切割边缘2002切穿组织，切割边缘和腿部分可以进一步延伸进入组织（图20B)，而基座部分2002保留在组织的表面上， 且不会抓住组织或以其它方式妨碍组织的切割。 As shown in FIG. 20A-B, the leg portions of the U- shaped spacer element 2001 may be made of a stretchable or extensible material, such as a cutting edge 2002 cut through the tissue, the cutting edge and the leg portion may extend further into the tissue (FIG. 20B), the base portion 2002 remains on the surface of the tissue, and does not catch or otherwise hinder tissue cutting tissue.
[0105] 在一些实施方案中，所述装置另外包括护套，在装置被导入患者中时，所述护套会覆盖切割边缘。 [0105] In some embodiments, the apparatus further comprises a sheath, when the device is introduced into a patient, the sheath can cover the cutting edge. 一旦已经将装置导入，可以去除护套。 Once it has been introduced into the device, the sheath may be removed. 在一些实施方案中，所述护套另外起取出切割的组织的作用。 In some embodiments, the sheath further serves to remove the cut tissue.
[0106] 在一些实施方案中，如图21A-21C所示，隔离件元件2101可以可移去地联接至组织改变装置的切割丝2102。 [0106] In some embodiments, as shown in FIG. 21A-21C, the spacer element 2101 may be removably coupled to the tissue modification device 2102 of the cutting wire. 通过滑动元件2103和/或脱离元件2104的组合，可以使隔离件元件联接至切割丝。 By combining the sliding element 2103 and / or 2104 of the disengagement element, the spacer element can be coupled to the cutting wire. 隔离件可以是柔性的、刚性的或半刚性的。 Spacer member may be flexible, rigid or semi-rigid. 优选地，隔离件在垂直于隔离件宽度的方向具有足够的刚性，以防止切割丝彼此接近至小于理想的宽度。 Preferably, the spacer member having sufficient rigidity in the vertical width direction of the separator member to prevent the cutting wire width close to each other less than desirable. 例如，理想的宽度可以是8-15mm，即椎体间装置的宽度和/或小关节的宽度或厚度。 For example, the width may be preferably 8-15mm, i.e., width and / or width or thickness of the facet joint interbody device. 隔离件2101可以在纵向是柔性的，并沿着它的宽度具有更低的柔性。 Spacer member 2101 may be flexible in the longitudinal direction, and has a lower flexibility along its width. 在一些实施方案中，如图21B和21C 所示，隔离件可以由有机硅材料或其它合适的聚合物制成。 In some embodiments, as shown in FIG. 21B and 21C, the spacer may be made of a silicone material or other suitable polymer. 在使用时，隔离件最初可以被下述元件联接至切割丝：朝向隔离件端部的滑动元件2103，和朝向隔离件中心的脱离元件2104，如图21A和21B所示。 In use, the separator can be initially coupled to the cutting wire of the following elements: the sliding element toward the end portion of the spacer member 2103, and 2104 from the element towards the center of the spacer, as shown in FIGS. 21A and 21B. 脱离元件可以滑动地连接或固定至切割丝上。 Detachment member slidably connected or fixed to the cutting wire. 隔离件构造成， 当在患者内定位丝时，和在组织改变装置抵靠着组织最初的往复运动过程中，维持切割丝之间的距离。 Spacer configured to, when the wire is positioned within the patient, and a tissue modification device against the first reciprocation tissue, maintain the distance between the cutting wire. 随着装置被跨着组织前后拉动（即往复运动），切割丝2102的暴露部分开始切穿骨和/或软组织。 As the device is pulled back and forth across the tissue (i.e., reciprocated), the exposed portion 2102 of the cutting wire cutting through the start bone and / or soft tissue. 在一些实施方案中，在装置跨组织往复运动的同时，抵靠着组织“向上”（向患者的背部）牵拉所述装置。 In some embodiments, while the device reciprocates across the tissue, tissue against the "up" (to the patient's back) the pulling means. 由于该向上的压力，切割丝开始切入组织，并在组织中建立槽。 Due to the upward pressure, start cutting wire to cut tissue, and establishing in the tissue slot. 随着切割丝切割组织，它们还会切穿脱离元件2104，使得隔离件从脱离元件释放出来，如图21C所示。 As the cutting wire cutting tissue, they also cut through the disengagement element 2104, so that the spacer member is released from the disengagement element shown in FIG 21C. 如全文所描述的，切割槽的另一益处是，通过把切割元件埋入在组织中建立的槽内，神经和血管结构（即非_靶组织）会有限地暴露于切割丝。 As another benefit of the cut groove described throughout is established through the cutting element is embedded in the tissue slot, neural and vascular structures (i.e., non-target tissue _) will be limited to the exposed cutting wire. 或者，脱离元件可以独立地释放切割丝，不需要被切割丝切断。 Alternatively, the elements may be independently released from the cutting wire, cut wire need not be cut off. 一旦隔离件被脱离元件释放，隔离件可以被允许在滑动元件2103处沿着切割丝滑动。 Once the separator member is released from the element, the spacer element may be allowed to slide along the sliding element cutting wire 2103. 该特征是合乎需要的，以便允许隔离件的端部沿着丝的长度向彼此滑动，使得隔离件的中心运动离开切割丝，如图21C所示。 This feature is desirable to allow the end portion of the spacer member slides towards each other along the length of the wire, so that the movement of the central member away from the cutting wire separator, shown in Figure 21C. 这允许切割丝更深地切入组织，隔离件不会妨碍或阻止丝一路切穿组织。 This allows the cutting wire cut deeper into tissue, the spacer does not interfere with or prevent the wire cut all the way through the tissue. 另外，隔离件可以构造成捕集或负载在隔离件和切割丝之间建立的距离内切割的和/或去除的组织。 Further, the spacer may be configured to trap or cut distance between the spacer and load cutting wire to establish and / or removal of tissue.
[0107] 图22A-22B图解了在切割丝之间的隔离件的一个替代变体的侧视图。 [0107] FIGS. 22A-22B illustrate a side view of an alternative variant between the cutting wire spacer. 如所示的， 隔离件2201经由滑动联接器2203和固定联接器2204联接至切割丝（仅显示了单根丝2202)。 As shown, via a sliding spacer 2201 and the coupler 2203 coupled fixedly coupled to the cutting wire 2204 (only a single filament 2202). 滑动联接器的位置相距固定联接器可以是距离y。 The coupling position of the slider apart from the fixed coupling can be y. 或者，两个联接器可以可滑动地联接至切割丝2202。 Alternatively, the two couplings can be slidably coupled to the cutting wire 2202. 随着切割丝跨组织往复运动，切割丝开始切入组织，在组织中建立槽。 With the cutting wire cross-organizational reciprocating cutting wire began to cut into the organization, established grooves in the organization. 随着切割丝更深地进入组织，隔离件沿着组织的外表面滑动（基本上在切入组织中的槽之间和/或以下）。 As the cutting wire deeper into the tissue, the spacer member slidable along an outer surface of the tissue (cut substantially in the grooves between the tissue and / or less). 隔离件因此必须与切割丝分开，使得切割丝可以继续更深地切割槽并移动进组织，而不受隔离件的限制。 Spacer member must be separated from the cutting wire, so that the cutting wire can continue to move deeper into the tissue and cutting the groove, without being limited by the spacer. 隔离件的滑动末端2203向隔离件的固定末端2204滑动，使得距离Y减小为Y'，并使得隔离件的中心和切割丝之间的距离X增加，如图22B所示。 End of the sliding spacer 2203 is fixed to the end of the sliding spacer 2204, so as to reduce the distance Y Y ', and such that the distance X between the center of the spacer and the cutting wire is increased, shown in Figure 22B.
[0108] 如图23A-23C所示，刚性的（或半刚性的）隔离件2301可以经由至少一个柔性部分2302联接至切割丝2304。 [0108] As shown in FIG. 23A-23C, a rigid (or semi-rigid) spacer member 2301 may be coupled 2302 to a cutting wire 2304 via at least one flexible portion. 柔性部分2302可以通过联接元件2303固定至切割丝。 The flexible section 2302 may be coupled by wire to the cutting element 2303 is fixed. 联接元件2303可以将柔性部分2302固定至切割丝2304，但是或者，可以可滑动地将柔性部分联接至切割丝。 The coupling element 2303 may be secured to the cutting portion 2302 of the flexible wire 2304, but alternatively, may be slidably coupled to the flexible portion of the cutting wire. 如上所述，刚性的隔离件被构造成将切割丝保持在理想的宽度。 As described above, a rigid spacer member is configured to cut the wire held in the desired width. 在定位装置时，和在开始最初的切割时，隔离件会使丝保持分开。 When the positioning means, and at the beginning of the first cut, the wire will remain separate spacer. 如分别在图23B和23C中的横截面视图和轴向视图所示的，随着切割丝2304更深地切入骨2305 (或其它组织），组织（具体地， 组织区段2307)会阻止隔离件进入由切割丝2304形成的槽2306中。 The cross-sectional view, respectively, and FIGS. 23B and 23C in the axial direction in the view shown, as the cutting wire cut deeper into the bone 2304 2305 (or other tissue), tissue (specifically, the tissue section 2307) will prevent the spacer member 2306 by the cutting wire into the groove 2304 formed. 隔离件因此“突然”离开和/或远离切割丝2304，由此拉直柔性部分2302。 Thus spacer "sudden" departure and / or away from the cutting wire 2304, thereby straightening the flexible portion 2302. 如图23C所示，随着切割丝更深地切入靶组织，隔离件保留在靶组织外面。 23C, as the cutting wire cut deeper into the target tissue, the spacer member remains outside the target tissue. 例如，组织区段2307可以包括小关节。 For example, tissue sections 2307 may include a facet joint. 随着切割丝往复运动并向上移动进入组织，最终组织的区段2307会从组织2305的其它部分彻底切掉。 As the cutting wire to reciprocate and move into the tissue, the final tissue section 2307 will be completely cut off from the other portions of tissue 2305.
[0109] 图24A图解了组织改变装置的俯视图，图24B图解了相同组织改变装置的后视图。 [0109] FIG 24A illustrates a plan view of a tissue modification device, FIG. 24B illustrates a rear view of the same tissue modification device. 显示的装置可以插入脊柱中并绕过小关节，例如，使得装置的顶部部分（图24A)面向靶组织（例如小关节），装置的底部部分（图24B)面向非靶组织（例如神经组织或血管组织）。 The display device may be inserted into and around the spine facet joint, for example, such that the top portion of the device (FIG. 24A) facing the target tissue (e.g., small joints), a bottom portion (FIG. 24B) means for non-target tissue (e.g., neural tissue or vascular tissue). 如图24A和24B所示，刚性的（或半刚性的）隔离件2401可以经由至少一个柔性部分2402 联接至切割丝2404。 As shown in FIGS. 24A and 24B, a rigid (or semi-rigid) spacer member 2401 may be coupled 2402 to a cutting wire 2404 via at least one flexible portion. 如所示的，柔性部分可以沿着组织改变装置的长度延伸，使得隔离件2401可以联接至柔性部分的背侧，如图24B所示。 As shown, the flexible portion may extend along the length of the device is changed tissue, so that the spacer 2401 may be coupled to the back side of the flexible portion, as shown in FIG. 24B. 在该变体中，柔性部分在位置2403处被固定至组织改变装置。 In this variant, the flexible portion 2403 at a position changing means is secured to the tissue. 如上所述，隔离件被构造成将切割丝保持在理想的宽度。 As described above, the spacer is configured to maintain the cutting wire at a desired width. 在定位装置时，和在开始最初的切割时，隔离件会使丝保持分开。 When the positioning means, and at the beginning of the first cut, the wire will remain separate spacer. 在该变体中，隔离件2401通过脱离元件2415联接至切割丝2404。 In this variant, the spacer element 2401 through 2415 from 2404 coupled to the cutting wire. 如上所述，脱离元件可以可滑动地连接或固定至切割丝上。 As described above, from the elements may be slidably connected to or fixed to the cutting wire. 随着装置被跨着组织前后拉动（即往复运动），切割丝2404会开始切穿骨和/或软组织。 As the device is pulled back and forth across the tissue (i.e., reciprocated), 2404 will begin cutting wire cutting through bone and / or soft tissue. 在一些实施方案中，在装置跨组织往复运动的同时，靠着组织“向上”（装置的上侧朝向患者的背部）牵拉所述装置。 In some embodiments, while the device reciprocates across the tissue, against the (upper side of the device toward the back of the patient) tissue "up" pulling the device. 由于该向上的压力，切割丝开始切入组织，并在组织中建立槽。 Due to the upward pressure, start cutting wire to cut tissue, and establishing in the tissue slot. 随着切割丝切割组织，它们还会切穿脱离元件2415，使得隔离件从脱离元件释放出来， As the cutting wire cutting tissue, they also cut through the disengagement element 2415, so that the spacer member is released from the disengagement element,
[0110] 在一个替代变体中，如图25所示，隔离件2501可以包括仅单个柔性部分2502。 [0110] In an alternative variant, shown in Figure 25, spacer 2501 may include only a single flexible portion 2502. 在该变体中，隔离件可以在第一末端2508处联接至切割丝2504，而柔性部分在第二末端2509 处联接至切割丝2504。 In this variant, the spacer element 2508 may be coupled to a first end of the cutting wire 2504, and the flexible portion at the second end 2509 is coupled to the cutting wire 2504. 如所示的，隔离件2501优选地在第一平面（跨装置的宽度，即在纸面中）是刚性的，使得它会阻止切割丝的接近。 As shown, spacer member 2501 is preferably in a first plane (across the width of the device, i.e. in the plane of the paper) is rigid, such that it will prevent access to the cutting wire. 隔离件可以在第二平面（沿着装置的长度） 和/或在第三个平面（跨装置的厚度，即相对于该图的上侧和下侧）是柔性的。 Spacer element can be in a second plane (along the length of the device) and / or in a third plane (across the thickness of the device, i.e. with respect to the upper and lower sides in the figure) is flexible.
[0111] 在另一替代实施方案中，如图26A-26C所示的刚性的或半-刚性的隔离件2601可移去地联接至切割丝2604。 [0111] In another alternative embodiment, illustrated in Figure 26A-26C shown a rigid or semi - rigid spacer member 2601 is removably coupled to the cutting wire 2604. 如图26A的横截面视图所示，随着切割丝2604更深地切入骨2605 (或其它组织)，组织2605会阻止隔离件进入由切割丝2604形成的槽2606中。 As shown in the cross-sectional view of FIG. 26A, as the cutting wire cut deeper into the bone 2604 2605 (or other tissue), tissue prevents the spacer 2605 enters the groove 2606 formed by the cutting wire in 2604. 隔离件因此“突然”离开和远离在组织2605内的切割丝2604，。 Thus spacer "sudden" away tissue and away from the cutting wire inside 26,052,604 ,. 如图26A所示，随着切割丝2604， 更深地切入靶组织，隔离件2601保留在靶组织外面。 26A, as the cutting wire 2604, cut deeper into the target tissue, the spacer retention element 2601 out of the target tissue. 在一些变体中，切割丝2604能够在隔离件的槽2612内滑动。 In some variations, the cutting wire 2604 can slide in the groove of the spacer 2612. 在该变体中，隔离件可以是静止的（即不做往复运动），而丝做往复运动。 In this variant, the spacer element may be stationary (i.e., not reciprocate), while the wire reciprocates. 隔离件的材料可以是模铸的聚合物，或者是挤压的聚合物。 Separator material may be a molded polymer, or extruded polymer. 材料的弹性性质会促进切割丝的装载和释放。 The elastic properties of the material and promotes release of the loading of the cutting wire. [0112] 在另一替代变体中，如图27A的横截面所示，不是“突然”离开切割丝2704，而是将隔离件2701构造成滑脱切割丝。 [0112] In another alternative variant, the cross-section shown in Figure 27A, instead of "sudden" away from the cutting wire 2704, but the spacer 2701 is configured to slip cutting wire. 在一些变体中，可以不从组织改变装置彻底去除隔离件， 而是从一部分切割丝去除，以允许切割丝2704的至少一部分切入和/或切穿组织。 In some variations, the tissue modification device may not be completely removed from the separator, but a portion is removed from the cutting wire, to allow at least a portion of the cutting wire 2704 cut and / or cut through the tissue. 在一些实施方案中，所述隔离件可以聚束bunch，并沿着切割丝折叠起来（fold up)，而不是彻底滑脱。 In some embodiments, the spacer may bunching Bunch, and folded along a cutting wire (fold up), instead of slipping off completely. 如图27A所示，隔离件可以另外包括联接元件2710，其构造成可移去地将隔离件联接至切割丝2704。 As shown, spacer 27A may further include a coupling element 2710, which is configured to be removably coupled to the cutting wire spacer 2704. 联接元件2710可以以任意合适的方式折迭、焊接或联接至切割丝。 The coupling element 2710 may be folded in any suitable manner, is coupled to the welding or cutting wire. 在一些变体中，可以用非切割缆索替代切割丝，且联接元件2710可以包括切割边缘（未显示）。 In some variations, the cutting wire may be replaced with non-cutting the cable, and the coupling member 2710 may include a cutting edge (not shown).
[0113] 图27B图解了（在横截面中）隔离件2705的一个替代实施方案。 [0113] FIG 27B illustrates an alternative embodiment of a spacer (in cross section) member 2705. 例如，如图27B 所示，所述隔离件可以包括切割脊2707。 For example, as shown in FIG 27B, the spacer member may include a cutting ridge 2707. 这些切割脊可以伸出，使得它们具有大于切割丝2706的直径的高度。 These ridges may extend the cutting, so that they have a height greater than the diameter of the cutting wire 2706. 切割脊可用于将切割丝保持为彼此相距一定距离，并阻止切割丝2706 接近。 Cutting ridge cutting wire may be used to maintain a distance from one another, and to prevent the cutting wire 2706 close. 将隔离件构造成，当在患者内定位丝时，和在组织改变装置靠着组织最初的往复运动过程中，维持切割丝之间的距离。 The spacer is configured such that when the wire is positioned within the patient, and a tissue modification device against the first reciprocation tissue, maintain the distance between the cutting wire. 随着装置被跨着组织前后拉动（即往复运动），切割脊开始切穿骨和/或软组织。 As the device is pulled back and forth across the tissue (i.e., reciprocated), Start cutting ridges cut through bone and / or soft tissue. 在一些实施方案中，在装置跨组织往复运动的同时，靠着组织“向上”（向患者的背部）牵拉所述装置。 In some embodiments, while the device reciprocates across the tissue, tissue against the "up" (to the patient's back) the pulling means. 由于该向上的压力，切割脊开始切入组织，并在组织中建立槽。 Due to the upward pressure, start cutting ridges cut into the organization, and the establishment of the slot in the organization. 可以在沿着装置的长度分开的位置，定位切割脊。 It may be in a separate location along the length of the device, positioning of the cutting ridge. 因此，由于最初的槽的形成， 最终，切割丝可以落入槽中，并随着隔离件移动离开切割丝，继续更深地切入槽。 Thus, since the first groove, finally, you can fall into the groove cutting wire, and with the spacer member is moved away from cutting wire, cut deeper into the groove continues.
[0114] 在任意上述变体中，隔离件可以另外构造成起罩的作用，所述罩用于在使用组织改变装置在患者内切割和/或改变组织时，防止非靶组织（诸如神经或动脉）受到损伤。 [0114] In any of the above variant, the spacer may be additionally configured to act from the cover, and a cover for use in a device for cutting tissue changed in a patient and / or altered tissue, to prevent non-target tissue (such as neural or artery) damage. 在一些实施方案中，所述隔离件和/或罩可以包括电极，且可以构造成检测神经结构，如结合图IC所述的。 In some embodiments, the spacer member and / or the cover may include an electrode, and may be configured to detect a neural structure, such as the IC in conjunction with FIG. 替换地或额外地，所述隔离件和/或罩可以构造成递送药物、止血剂或其它合适的药剂。 Alternatively or additionally, the spacer and / or the cover may be configured to deliver a drug, a hemostatic agent or other suitable agent. 在一些实施方案中，所述隔离件和/或罩可以是逐渐变细的。 In some embodiments, the spacer member and / or cover may be tapered. 例如，远端端部可以比近端端部更窄，使得使用者可以牵拉装置就位。 For example, the distal end portion may be narrower than the proximal end, such that a user may pull the device into place. 隔离件的逐渐变细的性质会确保，夕卜科医师可以在开始往复运动之前根据需要的程度牵拉装置，从而在把它们拉入组织中以前最佳地分离丝。 Properties of the tapered spacer ensures, Xi Boke physician may pull means to the extent required before starting the reciprocating motion, thereby turning them into tissue before pulling optimally separated filaments. 例如，为了执行根至根椎骨关节面切除术，使用者可以拉入装置，直到装置的每个侧面抵靠在根上。 For example, in order to perform root resection of the articular surface vertebrae, the user may pull the device until each of the sides of the device against the root.
[0115] 在一些实施方案中，所述装置可以构造成辅助粘附力的释放。 [0115] In some embodiments, the device may be configured to release assist adhesion. 例如，小关节囊或骨可以粘附至孔中的硬脑膜、神经或血管元件上。 For example, the facet joint capsule or bone hole may be adhered to the dural nerve or vascular elements. 为了促进外科医师或使用者的释放这些潜在粘附力的能力，并确保关节面不含有这些易受伤害的组织，下述的装置之一可能是有帮助的。 To facilitate the surgeon or the user's ability to release the potential of adhesion and to ensure that the articular surface did not contain these vulnerable tissue, one of the following devices may be helpful.
[0116] 在一些实施方案中，所述隔离件是如图28所示的滑块元件2801。 [0116] In some embodiments, the spacer 2801 is a slider element 28 shown in FIG. 滑块元件2801 联接至缆索2811，所述缆索可以联接至致动器（未显示），所述致动器位于装置的近端部分2812上，在一些实例中，在近端手柄处或附近。 The slider element 2801 is coupled to the cable 2811, the cable may be coupled to an actuator (not shown), the proximal portion of the actuator 2812 is located in the actuator means, in some examples, at or near the proximal end of the handle. 随着组织改变装置2800插入患者中并定位在患者内，朝向装置的组织改变部分的中心定位滑块，例如朝向切割丝2804的中心。 As the center apparatus 2800 is inserted into the patient and positioned within a patient, organizing means changes toward the centrally located portion of the slider, for example towards the cutting wire 2804 tissue changes. 如所示的，滑块的定位位置与切割丝的远端端部相距距离A，与切割丝的近端端部相距距离B。 As shown, the distal end portion of the cutting location of the slider a distance filaments A, and the proximal end of the cutting wire at a distance B. 使用者可以将远端部分（距离A)定位在靶组织附近。 User may distal portion (distance A) is positioned near the target tissue. 滑块2801可以限制往复运动的初始行程长度基本上为长度A。 Slider 2801 may limit the initial stroke length of reciprocation of a length substantially A. 更短的行程长度可以在往复运动过程中提供对丝的更大控制和/或更少的接近倾向。 Shorter stroke length may provide greater control over the wire and / or less tendency to approach the reciprocation. 一旦使用者已经用切割丝2804开始切割，和/或一旦切割丝已经在靶组织中形成初始槽，滑块可以向近端滑动，以使行程长度从长度A增加至等于或小于B的长度。 Once the user has begun to cut with the cutting wire 2804, and / or once the primary groove cutting wire has been formed in the target tissue, the slider can be slid proximally, so that the length of the stroke length is increased from A to B is equal to or less than the length. [0117] 如图四所示，在一个替代变体中，滑块四01可以具有分叉的构型。 [0117] shown in Figure IV, in an alternative variant, the slider 01 may have four bifurcated configuration. 处于该构型的滑块是刚性的，至少跨装置的宽度，以防止丝四04在往复运动过程中接近。 The configuration of the slider is rigid, at least across the width of the device, to prevent the wire 04 close to four reciprocation. 所述滑块可以分叉，使得分叉的部分可以插入由切割丝建立的槽中。 The slide may be bifurcated, such bifurcated portion may be inserted into the groove created by the cutting wire. 如上所述，所述滑块可以联接至致动 As described above, the slider may be coupled to an actuator
[0118] 图30A图解了小关节改变装置的一个变体的横截面，所述装置包括2个锯骨元件3002,3002'0所述2个锯元件（它们可以是包括刀片的缆索或表面）可以被隔离件3005 隔开。 [0118] FIG 30A illustrates a cross section of a small joint changes variant of the apparatus, the device comprising two saw elements of the saw 3002,3002'0 two bone elements (which may be a cable or a blade surface) 3005 may be separated by spacers. 图30C显示了小关节改变装置的一个变体的俯视图，所述装置构造成执行椎骨关节面切除术。 Figure 30C shows a plan view of a facet joint changes variant device, the apparatus is configured to perform the resection plane vertebral joint. 装置的远端端部构造成与牵拉丝联接，如上所述。 The distal end of the device is configured to be coupled with the pull wire, as described above. 装置的组织接触部分可以包括2个彼此分开的平行切割表面（它们可以是缆索）3002、3002'。 Tissue contacting portion of the device may comprise two separate cutting surfaces parallel to each other (which may be a cable) 3002,3002 '. 这2个分开的切割表面可以允许同时在小关节中做出2个切口，允许去除小关节的一部分。 This two separate cutting surfaces can be made simultaneously allow two notches in the facet joint, to allow removal of a portion of the facet joint. 该形式的小关节改变装置还可以包括一个或多个隔离件3005。 This form of the facet joint may also comprise means to change one or more spacers 3005. 隔离件可以防止切割表面彼此扩展或收缩，特别当切割表面是缆索时。 Spacer element can be prevented from cutting surface expansion or contraction of one another, especially when the cutting surface is a cable. 在一些变体中，这些隔离件可以是可去除的或分开的，使得随着小关节改变装置切割小关节，随着装置抵靠着骨的往复运动而施加的压力可以造成隔离件的分离、断裂或去除。 In some variations, these spacers may be removable or separate means such as a cutting facet joint facet joint changes, as the device abuts against the pressure applied to the reciprocating motion of the bone and may result in separation of the spacer member, broken or removed. 图30B图解了具有可断裂的（例如，脆弱的）隔离件3005的装置的一部分的横截面。 FIG 30B illustrates a cross-section of a portion of the device having a breakable (e.g., fragile) spacer 3005.
[0119] ♦会目■輕M _ ■棘- [0119] ♦ M will project light ■ _ ■ spine -
[0120] 其它小关节改变装置（包括在图31A-31E中所示的那些）可以包括单个组织改变表面，因而不需要隔离件。 [0120] Other means facet joint changes (including those shown in FIGS. 31A-31E) may comprise a single surface of the tissue changes, and therefore do not need a spacer. 在用于进行椎骨关节面切除术的方法的一个变体中，首先在关节中和/或围绕关节插入用于引导导丝/牵拉丝的具有插管的探针。 In a variant of the method the probes for performing vertebral resection of the articular surface, first in the joint and / or around the joint for inserting guide wire / pull wire having a cannula. 图32A图解了小关节3205，其包括在下椎骨3209和上椎骨3207之间的上关节突（SAP)和下关节突（IAP)。 FIG 32A illustrates a facet joint 3205, which includes an upper facet (the SAP) between 3209 and 3207 the lower vertebra and a lower vertebra articular process (IAP). 导丝/牵拉丝可以穿过小关节、围绕小关节或邻近小关节，如线3203通常指示的。 Guidewire / pull wire may pass through the small joints, small joints or around the adjacent facet joint, generally indicated by line 3203. 在一些变体中，穿过小关节的路径从上关节突（SAP)的顶部的上方经过。 In some variations, the path passes through a small joint from above the top articular process (the SAP) of. 在一些变体中，穿过小关节的路径从SAP的下面经过，接近SAP的尖部。 In some variations, the path through the small joints from below through the SAP, SAP near the tip portion. 通过撑开棘突，可以辅助围绕或穿过小关节的导丝的放置。 By distraction of the spinous process and to be placed auxiliary small guide wire around or through the joint. 因而，在一些变体中，可以在进行手术之前，撑开棘突。 Thus, in some variations, can be performed prior to surgery, distraction of the spinous process.
[0121] 一旦使用探针定位导丝，则可以取出探针。 [0121] Once the probe is positioned using a guide wire, the probe can be removed. 如上所述，探针可以包括一个或多个(同心的）插管，包括具有不同曲率的插管，从而可以围绕关节引导导丝，并指向适当的出口位点。 As described above, the probe may comprise one or more (concentric) cannula includes a cannula having different curvatures, such that the guide wire can be guided around the joint, and the exit point to the appropriate site. 然后可以穿过插管推动导丝或牵拉丝，并离开患者。 You can then push the guidewire through the cannula or pull wire, and away from the patient. 然后可以将远端手柄连接至导丝的远端端部，以辅助从远端端部操纵导丝/牵拉丝。 Then the distal end of the handle may be connected to the distal end of the guidewire to aid in manipulation of the guidewire from the distal end / pull wire.
[0122] 接着，通过将关节治疗装置的远端端部（或末端区域）联接至导丝/牵拉丝的近端端部，可以在关节中或围绕关节牵拉治疗装置就位。 [0122] Next, the distal end portion (or the end region) is coupled to the joint treatment device proximal end of the guidewire / pull wire may be in the joints or joints around pulling treatment device in place. 在一些变体中，所述治疗装置包括一个或多个表面，所述表面构造成磨损、刮擦或以其它方式去除骨，以执行椎骨关节面切除术。 In some variations, the therapeutic device comprises one or more surfaces, said surface configured to abrasion, scratching or otherwise remove bone to perform surgery vertebral articular surface. 例如，图31A-31E图解了治疗装置的变体。 For example, FIGS. 31A-31E illustrate a variant of the treatment device. 在图31A中，所述治疗装置包括前和后形成关节表面，它们可以被拉过关节表面，以将它们弄粗糙和/或从关节去除骨。 In FIG 31A, the treatment means comprise articulating surface forming the front and rear, which can be pulled over the articular surface, in order to get them rough and / or removal of bone from the joint. 在该实施例中，装置的远端端部包括导丝的连接位点/连接件位点。 In this embodiment, the distal end of the device includes a guide wire attachment site / site connector. 近端端部也包括长形部件，且可以具有近端手柄。 The proximal end of the elongate member also includes, and may have a proximal handle. 在一些变体中，粗糙化表面是可扩展的，使得它可以以收缩的或压缩的形式被拉入关节中（保护非靶组织），且一旦进入关节中，它可以扩展成治疗形式。 In some variations, the roughened surface is extensible, so that it can be contracted or compressed form drawn into joints (to protect non-target tissue), and once into the joint, which can be expanded into a therapeutic form. 例如，所述装置可以是可充气的；充气可以扩展装置，使得接触表面可以被推靠在关节表面上。 For example, the apparatus may be inflatable; inflatable device can be extended, so that the contact surface may be pushed against the articular surface. 一旦就位，通过用双手向远端和向近端（例如，前后）牵拉，可以在关节内或围绕关节移动装置，以刮擦或以其它方式改变关节，从而去除骨。 Once in place, by pulling proximally and distally (e.g., front) with both hands, or it may be in the joints around the joints mobile device to scraping or otherwise alter the joint, so as to remove the bone. [0123] 图31B-31D图解了所述的关节治疗装置的替代横截面。 [0123] FIGS. 31B-31D illustrate alternative cross-section of the joint treatment device. 例如，在图31B中，所述装置是基本上扁平的，具有上表面和下表面。 For example, in FIG 31B, the device is substantially flat, having an upper surface and a lower surface. 如所述的，该装置可以是可充气的/可扩展的， 以增加（或减少）上表面和下表面之间的空间，或“硬化”植入物（一旦其扩展）。 As described, the apparatus may be inflatable / expandable to increase (or decrease) the space between the upper and lower surfaces, or "hardening" of the implant (once its extension). 图31C 显示了具有椭圆形横截面的装置，图31D显示了具有圆形横截面的装置。 FIG 31C shows an oval cross-section of the apparatus, FIG. 31D shows a device having a circular cross-section. 在所有这些变体中，所述装置包括“齿”或突出物，它们构造成去除或改变骨或其它组织。 In all these variants, the apparatus comprising "teeth" or projections which are configured to remove or alter bone or other tissue. 在一些变体中，所述装置构造成磨损、切割和/或去除关节的软骨。 In some variations, the device is configured to abrasion, cutting and / or removal of articular cartilage. 在一些变体中，所述装置构造成磨损软骨，而基本上不切割或去除骨。 In some variations, the device is configured cartilage wear, while not substantially cutting or removing bone. 在一些变体中，装置表面构造成磨损、切割和/或去除关节的骨，和/或一起去除整个关节。 In some variations, the device surface is configured to wear, cutting and / or removal of bones and joints, and / or removal of the entire joint together.
[0124] 通过使它前后运动（向近端和向远端），通过双手往复运动，可以致动装置。 [0124] By making it moves back and forth (distally and proximally), reciprocation of both hands, may be actuated means. 在一些变体，例如在图31E中所示的那个变体中，例如，所述装置也可以或备选地，在它在关节中或围绕关节就位以后，通过在轴向旋转它来致动。 In some variations, for example, in the variant shown in FIG. 31E, for example, the device may also or alternatively, after it is in place in the joint or joints around by rotating it axially to actuate move.
[0125] 可扩展的组织改变装置和方法 [0125] Scalable tissue modification device and method
[0126] 本文所述的组织改变装置的一些变体包括：具有第一宽度和第二宽度的长形柔性元件，和联接至该柔性元件上的组织改变元件。 [0126] The tissue modification device described herein, some variations comprising: an elongate flexible member having a first width and a second width, and organizational change of the flexible element coupled to the element. 所述柔性元件可以包括扩展机构，其使柔性元件的至少一部分从第一宽度扩展成第二宽度。 The expansion mechanism may include a flexible member, the flexible elements which extend from at least a portion of a first width to a second width. 在下面更详细地描述和解释了这些特征中的每一个特征。 It describes and explains each of these features in more detail below.
[0127] 如图33所示，在一些实施方案中，所述组织改变装置包括具有第一宽度（未显示） 和第二宽度（显示出）的长形柔性元件3301。 [0127] As shown, in some embodiments, the changing means 33 comprises a tissue having a first width (not shown) and a second width (shown) of the elongated flexible member 3301. 所述柔性元件具有轴向长度、宽度（第一宽度和第二宽度）和厚度。 Said flexible member having an axial length, a width (first width and the second width) and thickness. 如所示的，轴向长度大于宽度，且宽度大于厚度。 As shown, an axial length greater than the width, and a width greater than the thickness. 在一些实施方案中，第一宽度可以基本上等于或小于厚度，且第二宽度可以大于厚度。 In some embodiments, the first width may be substantially equal to or less than the thickness and width may be greater than the second thickness. 第一宽度通常小于第二宽度。 The first width is generally less than the second width. 柔性元件优选地形成合适的尺寸，并构造成，使得它可以以第一宽度插入患者中， 然后扩展至第二宽度，以便改变靶组织。 The flexible element is preferably formed of a suitable size, and configured so that it can be inserted into a patient to a first width, and then expanded to a second width in order to change the target tissue. 例如，柔性元件可以扩展至第二宽度，以便环绕小关节，使得元件3302处于小关节的第一侧面（诸如上关节突（SAP))，元件3303处于小关节的第二侧面（诸如下关节突（IAP))。 For example the second side, the flexible element can be extended to a second width, so as to surround the small joints, such that the first side elements 3302 in the small joints (facet (the SAP) such as a), in the facet joint element 3303 (such as the inferior articular processes (IAP)). 在一些变体中，所述装置会改变或去除基本上等于或大于柔性元件的第二宽度的靶组织宽度。 In some variations, the device change or remove or substantially equal to the width of the target tissue is greater than a second width of the flexible element. 在一个具体实施例中，第一宽度可以是2-15mm，使得所述装置可以安装在患者脊柱的椎板间窗内。 In one particular embodiment, the first width may be 2-15 mm, so that the device may be mounted in a patient's spine lamina window. 第二宽度可以是5-20mm，使得所述装置可以改变5-20mm宽的组织宽度，诸如患者脊柱的小关节。 The second width may be 5-20mm, so that the device can change the width of 5-20mm wide organization, such as the small joints of the patient's spine. 在一些变体中，装置的第二宽度可以是在8-15mm范围内，使得使用者然后可以穿过在邻近的椎骨体之间的位置建立的开口， 插入椎体间装置诸如笼。 In some variations, the second width of the device may be in the range 8-15mm, so that the user may then pass through an opening in a position between adjacent vertebral bodies created, insert the interbody device such as a cage. 柔性元件可以调节至多个第二宽度。 The flexible member may be adjusted to a plurality of second width. 例如，柔性元件可以在第一宽度插入患者中，然后前进，使得它邻近靶组织，例如环绕小关节。 For example, the flexible element can be inserted into the patient in a first width, and then forward, so that it is adjacent to the target tissue, for example around the facet joint. 然后可以扩展柔性元件， 直到它接触邻近的根或其它合适的解剖结构，且可以不再扩展。 The flexible member may then be expanded until it contacts the adjacent roots, or other suitable anatomical structures, and can no longer be extended.
[0128] 柔性元件3301可以包括2个柔性长形缆索3302和3303，它们可以从第一宽度扩展至第二宽度。 [0128] The flexible element 3301 may comprise two elongated flexible cables 3302 and 3303, which may be extended from a first width to the second width. 所述丝可以构造成，使得对于柔性元件的第一宽度，所述丝彼此邻近，和/ 或基本上沿着它们的长度触碰。 The filaments may be configured such that a first width of the flexible element, the filaments adjacent to each other, and / or substantially touching along their length. 然后可以使所述丝彼此分开，如图33所示，使得柔性元件具有第二宽度。 The wire may then be separated from each other, as shown in FIG. 33, so that the flexible element has a second width. 缆索可以从装置的近端端部至装置的远端端部基本上彼此邻近地延伸。 Extends substantially adjacent to each other in the distal end of the cable means from the proximal end to a can device. 缆索的至少一部分是柔性的。 At least a portion of the cable is flexible. 可以使用任意适当的缆索，包括金属的或聚合的缆索。 You may use any suitable cable, comprising a metal or polymeric cables. 缆索可以是单丝的，或由多丝形成。 The cable may be monofilament or multifilament form. 如在该实施例中所示，缆索朝向装置的远端端部的部分可以通过铰链或以其它方式联接至联接元件3304。 As shown in this embodiment, the cable portion toward the distal end of the apparatus by a hinge or may be coupled to the coupling member 3304 in other ways. 联接元件3304可以构造成接收导丝或牵拉丝的末端，使得通过牵拉丝，可牵拉和/或定位柔性元件。 The coupling element 3304 may be configured as a receiving end of a guidewire or pull wire, so that the pull wire through, can be pulled and / or positioning the flexible member. [0129] 在图33中，装置的柔性元件3301连接至装置的近端端部3305，所述近端端部可以是更低柔性的，且可以包括手柄或手柄的连接区。 [0129] In FIG. 33, the flexible element 3301 is connected to the apparatus 3305 means proximal portion, the proximal portion may be less flexible, and may include a handle or grip connection area. 柔性缆索和近端端部和/或手柄之间的该接口可以是关节或铰链或任意其它合适的联接机构。 The interface between the flexible cable and the proximal end and / or handle may be a hinge or a joint or any other suitable coupling mechanism. 在近端端部附近的近端关节可以是球关节，在一些实施方案中，其允许装置的手柄和/或近端部分相对于装置的组织改变区域和/或柔性元件进行旋转。 In the vicinity of the proximal end of the proximal portion of the joint may be a ball joint, in some embodiments, which allow the handle means and / or the proximal portion of the device changes relative to the tissue region and / or a flexible element to rotate. 因而，可以沿着组织改变装置的长轴旋转近端手柄，但是基本上不扭曲装置的组织改变区域。 Accordingly, it is possible to change the long axis proximal end of the handle means along the tissue, but does not substantially distort organizing means change region. 在图33中显示的变体还可以包括在装置的近端端部3305 附近的近端连接区域，手柄与该连接区域相连。 Variant shown in FIG. 33 may further include a connection region 3305 near the proximal end of the proximal portion of the device, a handle connected to the connection region. 该连接区域可以是相对坚硬的（或非柔性的），或它也可以是柔性的。 The connection region may be relatively rigid (or flexible), or it may be flexible.
[0130] 在一些实施方案中，如下所述，柔性元件可以包括气球或其它合适的柔性元件。 [0130] In some embodiments, as described below, the flexible element may comprise a balloon or other suitable flexible member. 在一些实施方案中，如图34所示，柔性元件可以包括缆索环，而不是2条单独的缆索。 In some embodiments, shown in Figure 34, the flexible member may include a cable loop, instead of two separate cables. 缆索环3401可以从第一宽度扩展至第二宽度。 Cable loop 3401 may extend from a first width to the second width. 缆索环可以构造成，使得对于柔性元件的第一宽度， 环的2个侧面部分彼此邻近，和/或基本上沿着它们的长度触碰。 Cable loop may be configured such that a first width of the flexible element, the two side portions of the ring adjacent to each other and / or substantially touching along their length. 然后可以使环的2个侧面部分彼此分开，如图34所示，使得柔性元件具有第二宽度。 2 may then be separated from each other side portion of the ring, as shown in Figure 34, so that the flexible element has a second width. 所述装置可以另外包括滑轮3402或其它合适的齿轮或轮，如图34所示，缆索环可以围绕它缠绕。 The apparatus may further comprise a pulley 3402 or other suitable gear or wheel 34, the cable loop may be wound around it. 滑轮可用于使缆索环从第一宽度扩展至第二宽度，和/或可用于辅助缆索环的往复运动以切割组织，如下所述。 Pulley cable loop may be used to extend from a first width to a second width, and / or may be used to reciprocate the auxiliary cable loop to cut tissue, as described below.
[0131] 组织改变装置包括联接至柔性元件的组织改变元件。 [0131] tissue modification device comprises a flexible member coupled to a tissue change element. 在第一实施方案中，柔性元件包括至少一条丝，其构造成切割组织或以其它方式改变组织。 In a first embodiment, the flexible element comprising at least one filament which is configured to cut tissue or otherwise alter tissue. 所述丝可以是织构的或涂布的，使得它适用于切割组织。 The filaments may be textured or coated so that it is suitable for cutting tissue. 如图33所示，所述装置另外包括至少一个切割边缘3306，其联接至柔性元件3301的至少一部分。 As shown in FIG. 33, the apparatus further comprises at least one cutting edge 3306, which is coupled to at least a portion of the flexible member 3301. 在一些实施方案中，切割边缘压接在缆索上。 In some embodiments, the cutting edge crimped on the cable. 组织改变装置可以包括直接联接至缆索上的切割边缘，它可以包括穿在缆索上的套圈或珠子，所述缆索上固定有或集成有切割边缘，或所述装置可以包括以任意合适的方式联接至柔性元件上的任意其它合适的切割边缘。 Tissue may comprise changing means directly coupled to the cutting edge on the cable, which may include wear on the cable the collar or bead, said cable is fixed on or integrated with a cutting edge, or the device may comprise any suitable manner coupled to any other suitable flexible element on the cutting edge. 柔性元件可以包括切割元件，诸如珠子、刀片、丝或其它合适的切割元件。 A cutting element may comprise a flexible element, such as a bead, a blade, wire or other suitable cutting element. 如图33所示，装置的一部分可以包括切割缆索，同时装置的一部分包括穿在缆索上的横档（在横档上有或没有切割边缘）。 , A portion of the apparatus shown in FIG. 33 may include a cable cut, wear on the cable portion comprising the crosspiece (with or without the crosspiece at the cutting edge) while the apparatus. 通过抵靠着靶组织移动改变元件，组织改变装置可以改变或切割组织。 Changing element by abutting against the moving target tissue, tissue modification device may be altered or cut tissue. 在一些变体中，装置抵靠着靶组织往复运动。 In some variations, the means to reciprocate against the target tissue. 在一个替代实施方案中，柔性元件的第一缆索在第一方向抵靠着靶组织运动，第二缆索在第二方向抵靠着靶组织运动，然后每个缆索抵靠着靶组织往复运动。 In an alternative embodiment, a first flexible cable member against movement in a first direction against the target tissue, the second cable against the target tissue motion in a second direction, and each cable to reciprocate against the target tissue. 或者，在包括缆索环的柔性元件的情况下，所述环可以抵靠着靶组织旋转或被驱动，如图34所示。 Alternatively, in the case where the flexible member comprises a cable loop, said ring may be against the target tissue or driven rotation, shown in Figure 34.
[0132] 在一个替代实施方案中，使用能量，诸如热或射频能量，组织改变元件可以改变组织。 [0132] In an alternative embodiment, the use of energy, such as heat or radio frequency energy, the tissue modification device can alter tissue. 所述能量可用于烘干和/或收缩组织。 The energy can be used for drying and / or tissue shrinkage. 或者，所述能量可用于切割组织。 Alternatively, the energy can be used to cut tissue. 如图35所示，柔性元件可以另外包括切割环3500，其功能是切割、烘干和/或收缩靶组织。 As shown in FIG. 35, the flexible element 3500 may additionally comprise a cutting ring, whose function is cutting, drying and / or contraction of the target tissue. 在一些实施方案中，所述柔性元件联接至加热元件或其它能量源。 In some embodiments, the flexible member is coupled to the heating element or other energy source.
[0133] 在一些实施方案中，所述组织改变装置包括扩展机构，其使柔性元件的至少一部分从第一宽度扩展为第二宽度。 [0133] In some embodiments, the tissue modification device includes an extension means that at least a portion of the flexible member extend from a first width to a second width. 在第一实施方案中，如图36所示，柔性元件包括2条丝3601 和3602，它们可从第一宽度（A)扩展为第二宽度（B)。 In a first embodiment, shown in Figure 36, the flexible element comprises two wires 3601 and 3602, which may be extended from a first width (A) of a second width (B). 在一些实施方案中，所述扩展机构的其它功能是，使柔性元件保持就位，即，使它们保持间隔距离（第二宽度），并防止它们接近，特别当用所述装置改变组织时。 In some embodiments, the other function of the expansion mechanism is held in place by the flexible member, i.e., keeping them spaced distance (second width), and to prevent them from approaching, particularly if the tissue is changed by the device.
[0134] 在第一变体中，如图36所示，扩展机构3603联接在2条丝3601和3602之间，并 [0134] In the first variant shown in Figure 36, expansion mechanism 3603 is coupled between the two wires 3601 and 3602, and
随着扩展机构沿着丝的长度移动，将丝从第一宽度分离为第二宽度。 With the expansion mechanism along the longitudinal wire, the wire is separated from the first width to the second width. 扩展机构可以是三角形，或以其它方式构造成以与拉链或ZIP-LOCK袋滑动机构类似的方式起作用。 Expansion mechanism may be triangular, or otherwise configured to the fastener or ZIP-LOCK bags slide mechanism functions in a similar manner. 或者，如图37所示，扩展元件可以是扩展杆3703。 Alternatively, as shown in FIG. 37, the extension member 3703 may be an extension bar. 一旦丝就位（即，插入患者中和/或邻近靶组织）， 该杆可以插入2条丝或缆索之间，且可以形成合适的尺寸，并构造成使柔性元件从第一宽度（A)扩展至第二宽度（B)。 Once the wire in place (i.e., inserted into a patient and / or adjacent the target tissue), the rod may be inserted between two wires or cables, and the suitable size can be formed, and the flexible element is configured from a first width (A) extends to a second width (B).
[0135] 在一个替代实施方案中，如图38所示，扩展机构包括第一元件3801和第二元件3804，所述第一元件在第一位置联接至2条丝3802和3803，所述第二元件在第二远端位置联接至这2条丝。 [0135] In an alternative embodiment, shown in Figure 38, the extension mechanism includes a first member 3801 and second member 3804, the first element is coupled to the two wires 3802 and 3803 in the first position, the second this element is coupled to the two wires in the two second distal position. 当所述丝间隔第一宽度时，所述装置可以插入患者中，然后通过使第一元件3801向第二元件3804移动，如图38所示，丝从第一宽度扩展至第二宽度。 When the distance between the first filament width, the device may be inserted into a patient, and then through the first member moves the second member to 38,013,804, 38, the wire extended from the first width to the second width.
[0136] 如图39和40所示，扩展机构可以包括框架3900，其可从第一宽度（未显示）扩展为第二宽度。 [0136] 39 and 40, the expansion mechanism may include a frame 3900, which may be from a first width (not shown) extended second width. 所述框架可以是形状记忆材料（诸如镍钛记忆合金）或任意其它形状记忆的、形状改变的或超弹性的材料。 The frame may be a shape memory material (such as Nitinol), or any other shape memory or superelastic shape change of the material. 所述框架可以包括至少2个框架部分（诸如丝3901和3902)，其可从第一宽度扩展为第二宽度。 The frame may comprise at least two frame portions (such as wire 3901 and 3902), which is expandable from a first width to a second width. 在第一实施方案中，如图39所示，所述框架可以另外包括网孔3903或联接至框架部分之间的框架上的其它材料。 In a first embodiment, shown in Figure 39, the frame 3903 may further comprise a mesh or other material between the upper frame coupled to the frame portion. 网孔可用于捕获和/或去除切割的或改变的靶组织。 Mesh can be used to capture and / or removal of the target tissue cutting or altered. 诸如小关节。 Such as facet joint. 在一些实施方案中，所述框架可以不是完全环绕网孔材料，例如，所述框架可以包括远端端部和近端端部。 In some embodiments, the frame may not completely surround the mesh material, for example, the frame may comprise a distal end and a proximal end. 每个端部具有可扩展的叉结构。 Each end portion has a fork structure may be extended.
[0137] 如图40所示，框架可以另外包括联接至框架4000上的套筒4001。 [0137] As shown in FIG. 40, the frame 4001 can additionally include a sleeve 4000 is coupled to the frame. 所述套筒可以具有基本上等于柔性元件的第一宽度的宽度，使得框架可以插入套筒中，并保持第一宽度。 The sleeve may have a width substantially equal to the first width of the flexible element so that the frame can be inserted into the sleeve, and holds the first width. 然后可以向后牵拉套筒（显示在图40中，在向后牵拉的位置），以允许框架分离。 The sleeve may then be pulled rearwardly (shown in FIG. 40, in a position rearward drawing), to allow the frame separated. 当在改变组织后取出装置时，在一些实施方案中，框架可以构造成随着框架收缩（如箭头4003所示）而抓住改变的靶组织4002，并用框架将组织向后拉到套筒4001中，以便容易地取出组 When the tissue retrieval device after the change, in some embodiments, the frame may be configured as the shrinkage frame (as shown by arrow 4003) to change the target tissue 4002 to seize and pull the tissue by the frame rearwardly of the sleeve 4001 in order to easily remove the group
[0138] 如图41Α和41Β所示，在一些实施方案中，所述扩展机构是气球4100。 [0138] FIG 41Α 41Β and, in some embodiments, the expansion means is a balloon 4100. 处于该构型的装置可以具有切割刀片4101，其联接至气球的侧面部分，使得刀片可以切割组织的宽度基本上等于处于它的充气的或扩展的构型的气球的宽度。 Means in this configuration 4101 may have a cutting blade, which is coupled to the side portion of the balloon, so that the width of the blade can cut tissue in a width substantially equal to its inflated or expanded configuration of the balloon. 在该实施方案中，所述气球可以另外包括钩4102，其构造成例如捕获软组织（例如韧带）。 In this embodiment, the balloon 4102 may further include a hook, which is configured to capture, for example, a soft tissue (e.g. ligaments).
[0139] 如图41C和41D所示，所述扩展机构可以是致动器4103(图41Β)或致动器4104(图41C)。 As shown in [0139] FIG. 41C and 41D, the extension mechanism may be an actuator 4103 (FIG. 41 [beta]) or actuator 4104 (FIG. 41C). 在第一变体中，如图41C所示，致动器4103是弹簧或活塞，其扩展和收缩， 以使柔性元件4105从第一宽度移动至第二宽度（显示出）。 In a first variant, shown in FIG. 41C, the actuator 4103 is a spring or a piston which expands and contracts, so that the flexible member 4105 from a first width to a second width (shown). 在第二变体中，如图41D所示， 致动器是丝4104，其由形状记忆材料（诸如镍钛记忆合金）或任意其它形状记忆的、形状改变的或超弹性的材料制成。 In a second variant, shown in FIG. 41D, the actuator is a wire 4104, which is a shape memory material (such as Nitinol), or any other shape memory made of superelastic or shape change of the material. 如所示的，所述丝可以联接至柔性元件4105，且是可扩展的，因而它可以使柔性元件从第一宽度移动至第二宽度（显示出）。 As shown, the filaments may be coupled to a flexible member 4105, and is extensible, so that it enables the flexible element from a first width to a second width (shown).
[0140] 如图42所示，所述装置可以包括联接至柔性元件的罩4200。 [0140] shown in Figure 42, the apparatus may include a cover member coupled to a flexible 4200. 所述罩可以联接至柔性元件4201，使得当柔性元件邻近靶组织时，所述罩会保护邻近的非靶组织，诸如神经组织，和/或可以收集由所述装置切割和/或改变的组织。 The cover 4201 may be coupled to a flexible member, such that when the flexible element adjacent the target tissue, the cover will protect the adjacent non-target tissue, such as neural tissue, and / or may be collected by said cutting means and / or altered tissue . 在一些实施方案中，所述柔性元件的功能是，在基本上静止的罩内或上面，向远端和向近端滑动。 In some embodiments, the function of the flexible member, or above, the sliding proximally and distally within a substantially stationary housing. 在一些实施方案中，所述罩可用于接触和/或啮合由所述装置切割和/或改变的组织（例如，小关节），并取出所述组织。 In some embodiments, the cap may be used for contacting and / or engaged by the tissue cutting and / or altered (e.g., facet joint) of the device, and remove the tissue. 在一些实施方案中，如图42所示，柔性元件包括2条丝4202和4203，它们联接至罩上， 并保持为彼此相距一定距离。 In some embodiments, shown in Figure 42, the flexible element comprises two wires 4202 and 4203, which are coupled to the cover, and is kept at a distance from one another. 所述罩联接在柔性元件的下表面附近，且形成合适的尺寸，并构造成，通过防止缆索在改变组织时彼此接近，维持柔性元件的宽度。 The cover is coupled in the vicinity of the lower surface of the flexible member, and an appropriate size is formed, and configured to, by preventing the cable close to each other when changing the tissue, to maintain the width of the flexible member. [0141] 在一些实施方案中，所述装置可以包括跟踪元件。 [0141] In some embodiments, the apparatus may comprise a tracking element. 例如，跟踪元件可以设置在装置的远端端部，使得随着装置插入患者中和/或在患者内移动，可以跟踪装置的尖部。 For example, the tracking element may be provided at the distal end of the device, such that the tip is inserted into the patient with the device and / or move within the patient, the device can be tracked. 或者， 所述装置可以包括多个沿着装置的长度设置的跟踪元件，或多个沿着装置的长度的一部分(例如沿着装置的切割区域）设置的跟踪元件。 Alternatively, the device may comprise a plurality of track elements arranged along the length of the device, or along a portion of the length of the apparatus a plurality of tracking elements (e.g., along the dicing region of the device) provided. 在一些实施方案中，所述跟踪元件是通过成像系统可检测出的材料。 In some embodiments, the tracking element is detected by the imaging system material. 合适的跟踪元件的一些实例包括通过超声系统可检测出的发生回波的材料或物质（即构造成形成发生回波的表面），和通过放射显影系统（诸如荧光镜）可检测出的不透射线的材料。 Some examples of suitable trace elements include an echogenic material or a substance detectable by the ultrasound system (i.e., configured to form echogenic surface), and by autoradiography system (such as fluoroscopy) can be detected radiopaque material line. 或者，跟踪元件可以构造成通过MRI或红外线系统可检测出。 Alternatively, the tracking element may be configured by an infrared system or MRI detectable. 在一些实施方案中，所述跟踪元件优选地是线圈，其构造成通过电磁跟踪或导航系统进行检测。 In some embodiments, the tracking coil element is preferably configured to be detected by electromagnetic tracking or navigation system. 例如，本文所述的装置可以包括跟踪系统，诸如AXIEM™电磁跟踪技术，例如， StealthMation ®AXIEM™(Medtronic Navigation, Louisville, CO. USA)。 For example, devices described herein may include a tracking system, such as electromagnetic tracking AXIEM ™ technology, e.g., StealthMation ®AXIEM ™ (Medtronic Navigation, Louisville, CO. USA). 在一些实施方案中，所述装置构造成在患者的靶解剖结构附近产生电磁场，其可以被跟踪，以三角定位具有跟踪元件的装置。 In some embodiments, the device is configured to generate an electromagnetic field in the vicinity of the target in the patient's anatomy, which may be tracked, the tracking means having a triangular positioning element.
[0142] 如上所述，本文所述的任意装置可以包括导丝联接器。 [0142] As described above, any of the devices described herein can include a guidewire coupling. 导丝联接器构造成连接至导丝（例如，导丝的一个末端），使得在导丝已经固定至装置上以后，通过牵拉导丝，可以至少部分地操纵装置。 Guide wire configured to be connected to the coupling wire (e.g., a tip of a guidewire), so that the guide wire has been secured to the apparatus after the guide wire by pulling, may be at least partially actuating device. 例如，在一些变体中，导丝可以从身体外面的第一位置插入体内，然后围绕靶组织（例如，围绕椎孔）穿过，并从第二位置离开身体。 For example, in some variations, the guide wire can be inserted into the body from a first position outside the body, and then passes through around the target tissue (e.g., surrounding the vertebral foramen), and a second position away from the body. 然后可以将导丝的远端端部联接至组织改变装置（诸如图33中所示的装置），并拉入身体中，直到装置的组织改变区域（例如，包括组织改变元件3306的装置部分）被定位在靶组织对面。 Then the distal end of the guidewire is coupled to the tissue may be changed (such as the device shown in FIG. 33) means, and pulled into the body, until the tissue area varying means (e.g., including tissue modification device section element 3306) It is positioned opposite the target tissue. 在一些变体中，使用的导丝包括尖部区域，其被扩大，且可以接合导丝联接器。 In some variations, the guide wire includes a tip region for use, which is enlarged, and the coupler may engage the guidewire. 例如，所述导丝可以具有含有凸缘或球的近端端部。 For example, the guidewire may have a proximal end comprising a flange or balls. 该扩大的区域可以构造成安装进导丝联接器上的开口中，使得可以从患者外侧向远端牵拉导丝。 The enlarged area may be configured to be mounted on a guide wire into the opening in the coupling, such that the guide wire can be pulled from outside the patient to the distal end. 在一些变体中，装置的远端端部可以完全缩回，使得它可以被抓紧和操纵。 In some variations, the distal end of the device may be fully retracted, and the grip that it can be manipulated. 在其它变体中，组织改变装置的远端端部保持联接至导丝，且所述导丝可以被抓紧，以操纵组织改变装置的远端端部。 In other variations, the tissue distal end coupled to the varying means holding the guidewire, and the guidewire may be grasped to manipulate the distal end of the tissue modification device. 可以将手柄连接至导丝上。 The handle may be attached to the guidewire. 如所述的，在操作中， 所述装置被推压在靶组织上，且可以在向近端/向远端方向移动，以改变（例如，切割）靶组织。 As described, in operation, the device is pressed against the target tissue, may be moved proximally and / distal direction, to change (e.g., cut) the target tissue. 例如，可以牵拉组织改变装置的近端端部和远端端部两者，以将装置推压在靶组织上，且可以比其它手柄更大程度地交替牵拉每个端部，以使装置在靶组织上滑动，允许切割边缘切割和改变靶组织。 For example, tissue can be pulled both the proximal and distal ends of the device changes to the device pressed against the target tissue, and may be alternately pulling each end of the handle to a greater extent than the other, so that slide means on the target tissue, allowing the cutting edge to cut and change the target tissue.
[0143] 例如，导丝联接器可以包括开口和/或通道，以接收在导丝的近端端部处的扩大的区域或颈区域。 [0143] For example, the guidewire may include a coupling opening and / or channels, to expand the area or region of the neck at the proximal end received in a guidewire. 该构型可以类似于“拖车栓钩”构型，所述构型描述在很多之前以引用方式并入的参考文献中。 This configuration may be similar to "trailer hitch" configuration, the configuration described in numerous prior references are incorporated by reference.
[0144] 本文所述的改变组织的方法通常包括一个或多个下述步骤：插入具有第一宽度的长形柔性元件；使柔性元件前进，直到柔性元件的一部分邻近靶组织；至少扩展邻近靶组织的柔性元件部分至第二宽度；以及用柔性元件改变靶组织。 [0144] The method described herein altered tissue typically comprises one or more of the following steps: inserting an elongate flexible element having a first width; the flexible element is advanced until a portion of the flexible member adjacent to the target tissue; extended at least adjacent the target the width of the flexible member to the second tissue section; and changing the target tissue with a flexible element. 改变组织的方法可以包括这些步骤中的一个或多个的任意组合。 Changing the organization of these methods may include any combination of one or more of the steps of. 在下面更详细地描述和解释了这些步骤中的每一个步 Described in more detail below and illustrated in each of these steps in step
[0145] 插入的作用是使装置就位。 [0145] The insertion of the device into place role. 所述插入步骤可以另外包括：将装置插入患者中，更具体地，插入例如患者的脊柱中。 The insert may further comprise the step of: inserting the device into the patient, more specifically, for example, inserted into the patient's spine. 在一些变体中，可以穿过患者脊柱的椎板间窗而插入装置。 In some variations, the device may be inserted through the patient's spinal lamina window. 在该变体中，柔性元件优选地构造成第一宽度。 In this variant, the flexible element is preferably configured as a first width. 所述第一宽度可以等于或小于由2个相邻的椎板限定的空间（即椎板间窗）。 The first width may be equal to or less than the two adjacent laminae defining a space (i.e., interlaminar window). 一旦插入，可以使装置前进就位。 Once inserted, the device can be forward position. 可以移动装置，直到它邻近靶组织。 Movable means until it is adjacent the target tissue. 在一些实施方案中，所述前进步骤另外包括下述步骤：至少部分地围绕靶组织穿过导丝，并使用导丝围绕靶组织牵拉装置，使得柔性元件和/或切割元件邻近靶组织。 In some embodiments, the advancing step further comprises the steps of: at least partially surrounds the target tissue through the guide wire, drawing the target tissue using the apparatus about the guide wire, such that the flexible member and / or cutting element adjacent the target tissue. 在一些实施方案中，所述导丝在装置的远端部分处联接至导丝联接器。 In some embodiments, the guidewire coupled to a guidewire at a distal end portion of the coupling device. 当柔性元件构造成第一宽度时，可以进行所述插入和前进步骤。 When the flexible element is configured as a first width, and may be the inserting step forward. 这允许装置更小和更容易操作，使得它可以穿过和围绕紧密的解剖空间和位置进行安装。 Smaller and apparatus which allows easier operation, such that it can be mounted around and through tight spatial and anatomical location.
[0146] 一旦在患者内正确地定位好装置，可能希望使柔性元件从第一宽度扩展至第二宽度。 [0146] Once properly positioned within a patient means good, the flexible member may be desirable to extend from a first width to the second width. 扩展的宽度（第二宽度）比第一宽度更宽，并允许联接至柔性元件上的切割元件改变更宽的和/或更大的靶组织的部分或区域。 Extension width (second width) is wider than the first width, and allows coupling to the cutting element on the flexible element changes wider and / or target tissue or region of a larger portion. 在一些实施方案中，所述第二宽度可以基本上等于（或稍微小于）小关节的宽度、患者脊柱的神经孔的宽度、和/或椎体间融合装置的宽度。 In some embodiments, the second width may be substantially equal to (or slightly less than) width, the neural foramen of the patient's spine facet joint, the width of the device and / or spinal fusion. 在一些实施方案中，所述第二宽度可以基本上等于（或稍微小于）从第一根至邻近根的距离。 In some embodiments, the second width may be substantially equal to (or slightly less than) the first distance from the root to adjacent the root. 一旦扩展装置后，可以使用更宽的装置以改变靶组织。 Once the extension device, the device may be used in a wider change the target tissue.
[0147] 在一些实施方案中，所述改变步骤另外包括：跨靶组织移动柔性元件。 [0147] In some embodiments, the changing step further comprises: moving the flexible member across the target tissue. 可以穿过靶组织或在靶组织上移动柔性元件。 You can move through the target tissue or target tissue in the flexible member. 柔性元件也可以跨靶组织往复运动或前后运动，以便改变靶组织区域。 The flexible member may be reciprocated across the target tissue or back and forth movement, in order to change the target tissue region. 改变元件可以在远端位置和近端位置之间往复运动。 Changing element can reciprocate between a distal position and a proximal position. 可以如下使装置往复运动：通过在装置的近端端部和远端端部两者施加张力，以抵靠着靶组织驱动柔性元件和/或组织改变元件。 Means to reciprocate can be made as follows: By applying tension in both the proximal and distal ends of the device to the target tissue against the flexible drive element and / or tissue changing element.
[0148] 在一些实施方案中，改变靶组织可以包括：切割一定宽度的组织，诸如小关节，其具有与柔性元件的第二宽度基本上相等的宽度。 [0148] In some embodiments, the target tissue may change comprising: a cutting width of a certain tissue, such as the facet joint, having a flexible element with a second width substantially equal width. 如图43所示，或者，所述的改变组织的方法可以包括下述步骤中的一个或多个步骤：在第一位置处，将第一长形柔性元件4300插入患者中；使第一柔性元件前进，直到柔性元件的一部分邻近靶组织；在所述第一位置处，将第二长形柔性元件4301插入患者中，其与第一柔性元件相距一定距离；以及用柔性元件改变靶组织。 43, or the method of changing the tissue may comprise the steps of one or more of the steps: at a first location, the first elongated flexible member 4300 is inserted into the patient; the first flexible element is advanced until a portion of the flexible member adjacent to the target tissue; at the first position, the second elongated flexible member 4301 is inserted into a patient, which is a distance from the first flexible member; and changing the target tissue with a flexible element. 改变组织的方法可以包括这些步骤中的一个或多个的任意组合。 Changing the organization of these methods may include any combination of one or more of the steps of. 在下面更详细地描述和解释了这些步骤中的每一个步骤。 It describes and explains each of these steps in more detail below.
[0149] 在一些实施方案中，插入第二柔性元件步骤另外包括：相距第一柔性元件一定距离，插入第二柔性元件，其中所述距离基本上等于小关节的宽度。 [0149] In some embodiments, the step of inserting the second flexible member further comprises: a first flexible member a certain distance apart, inserting the second flexible member, wherein said distance is substantially equal to the width of the facet joint. 或者，插入第二柔性元件步骤可以另外包括：相距第一柔性元件一定距离，插入第二柔性元件，其中所述距离基本上等于椎体间融合装置的宽度。 Alternatively, the flexible element is inserted into the second step may further comprise: a first flexible member a certain distance apart, inserting the second flexible member, wherein said distance is substantially equal to the width of the interbody fusion device. 一旦插入，2个柔性元件可以联接至远端手柄4302和/或近端手柄4303。 Once inserted, the flexible member 2 can be coupled to the distal end of handle 4302 and / or the proximal handle 4303. 所述方法可以另外包括下述步骤：将第一柔性元件的远端端部联接至远端手柄，然后将第二柔性元件的远端端部联接至远端手柄。 The method may further comprise the steps of: coupling a distal end of the first flexible member to the distal end of the handle, and the distal end of the second coupling of the flexible member to the distal end of the handle.
[0150] 这些步骤具有下述益处，即可以穿过紧密的解剖位点和位置，插入单个柔性元件， 并容易地独立地操作。 [0150] These steps has the benefit that may pass through the anatomical site and close positions, inserting a single flexible element, and to easily operate independently. 通过随后以与第一柔性元件成一定角度或距离插入第二柔性元件(其也是可以容易地独立地操作），使得柔性元件的组织改变部分彼此邻近和间隔一定距离（例如基本上等于小关节的宽度或椎体间融合装置的宽度的距离），且可以改变基本上等于该距离的组织部分。 Followed by a second flexible member and the first flexible member is inserted at an angle or distance (which also can be easily operated independently), the flexible member such that the tissue portions adjacent to each other and changing a distance (e.g., substantially equal to the facet joint the width of the width or distance interbody fusion devices), and may be varied substantially equal to the distance of the tissue portion. 在一些实施方案中，所述2个柔性元件的功能是，切割一条靶组织，其具有基本上等于柔性元件之间的距离的宽度。 In some embodiments, the flexible element 2 functions to cut a target tissue, which is substantially equal to the distance between the flexible element width.
[0151] 递送装置和方法 [0151] delivery apparatus and methods
[0152] 图44图解了用于递送组织改变装置的递送装置的一个实施方案，所述组织改变装置用于从患者去除组织。 [0152] FIG. 44 illustrates an embodiment of a delivery device for delivering tissue changing device, the tissue modification device for removing tissue from a patient. 在一些实施方案中，所述装置包括条带形柔性长形主体4401，所述主体具有由第一边缘4402和第二边缘4403限定的宽度。 In some embodiments, the device comprises a strip-shaped flexible elongate body 4401, the body having an edge defined by a first edge 4402 and second width 4403. 在一些实施方案中，第一边缘和第二边缘是基本上平行的。 In some embodiments, the first and second edges are substantially parallel. 所述装置还可以包括第一通道和第二通道，所述第一通道沿着长形主体的长度的一部分设置，朝向长形主体的第一边缘定位，所述第二通道沿着长形主体的长度的一部分设置，朝向长形主体的第二边缘定位。 The apparatus may further comprise a first and second channels, the first channel disposed along a portion of the length of the elongate body, the elongate body toward a first edge location, the second channel along the elongate body a portion of the length of the elongate body toward the second edge is positioned. 如所示的，所述通道可以由元件4404和4405制成。 As shown, the channel element may be made of 4404 and 4405. 或者，制备的通道包括单个管状元件（未显示）。 Alternatively, the prepared channel member comprising a single tubular (not shown). 所述通道形成合适的尺寸，并构造成接收2个长形切割部件4406。 The passage forming an appropriate size, and configured to receive two elongated cutting member 4406. 在一些实施方案中，所述装置还可以包括导丝联接器（未显示），其在长形主体4401的远端端部区域处。 In some embodiments, the apparatus may further include a coupling guide wire (not shown), which end region of the distal end of elongate body 4401.
[0153] 本文还描述了用于递送组织改变装置的方法，所述组织改变装置用于从患者去除组织。 [0153] Also described herein is a method for delivering the tissue modification device, the tissue modification device for removal of tissue from a patient. 在一些实施方案中，所述方法包括下述步骤：在第一位置处，将长形柔性罩4401插入患者中；使罩前进，直到罩的一部分邻近靶组织；穿过罩插入第一长形柔性切割元件4406， 直到第一切割元件的一部分邻近靶组织；穿过罩插入第二长形柔性切割元件4406，其相距第一切割元件一定距离，且与第一切割元件基本上平行，直到第二切割元件的一部分邻近靶组织；以及用柔性元件改变组织。 In some embodiments, the method comprises the steps of: at a first location, the elongated flexible cover 4401 is inserted into the patient; the cover advanced until a portion of the target tissue adjacent the shroud; first inserted through the elongated housing flexible cutting element 4406, until a portion of the target tissue adjacent the first cutting element; through the cover inserted into the second elongated flexible cutting member 4406, a first cutting element which is spaced a distance from, and substantially parallel to the first cutting element, until two adjacent portion of the target tissue cutting element; and changing a flexible element with the tissue.
[0154] 在一些实施方案中，所述方法包括下述步骤：插入第一长形柔性切割元件4406， 直到第一切割元件的一部分邻近靶组织；使长形柔性罩4401在患者中前进，其中所述罩的一部分在第一长形柔性切割元件上面前进；穿过罩插入第二长形柔性切割元件4406，其相距第一切割元件一定距离，且与第一切割元件基本上平行，直到第二切割元件的一部分邻近靶组织；以及用柔性元件改变组织。 [0154] In some embodiments, the method comprises the steps of: inserting a first elongated flexible cutting member 4406, until a portion of the target tissue adjacent the first cutting element; that the elongated flexible cover 4401 proceeds in a patient, wherein the forward part of the cover of the first elongate flexible cutting element thereon; inserting the cover through the second elongated flexible cutting member 4406, a first cutting element which is spaced a distance from, and substantially parallel to the first cutting element, until two adjacent portion of the target tissue cutting element; and changing a flexible element with the tissue. 在一些实施方案中，所述方法另外包括下述步骤：从患者取出罩4401，同时使切割元件在患者内保持就位。 In some embodiments, the method further comprising the step of: the cover 4401 removed from the patient, while the cutting element is held in place within the patient.
[0155] 本文提供了组织改变装置和系统的不同实施方案，以及制备和使用组织改变装置和系统的方法。 [0155] Provided herein are methods of various embodiments of tissue modification devices and systems, as well as preparation and use of tissue modification devices and systems. 一般而言，本文所述的柔性的组织改变装置构造成从患者去除组织。 Generally the flexible tissue herein varying means is configured to remove tissue from the patient. 具体地，这些组织改变装置可以构造成执行组织去除，诸如椎骨关节面切除术。 Specifically, the tissue modification device can be configured to perform tissue removal, such as a vertebral joint resection plane. 这些装置通常包括柔性长形主体，其从近端向远端（近端/远端）延伸，并构造成插入患者中，使得它围绕靶组织（诸如脊柱的小关节）延伸，所以通过向装置的任一个末端施加张力，可以抵靠着靶组织牵拉它。 These devices generally include a flexible elongate body extending distally from the proximal end (proximal / distal), and configured to be inserted into a patient, so that it surrounds the target tissue (such as the small joints of the spine) extends through the apparatus so that any tension applied to one end of, the target tissue can be pulled against it. 因而，所述装置可以延伸进入或穿过椎孔，和/或围绕脊椎小关节。 Thus, the device may extend into or through the vertebral foramen, and / or around the facet joint.
[0156] 尽管许多下面的描述和附图通常集中于在脊柱中的外科手术，在替代实施方案中，本发明的装置、系统和方法可以用于患者身体中的许多其它解剖学位置中的任一处。 Although many of the following description and the accompanying drawings in surgery typically focused on the spine, and in alternate embodiments, apparatus, systems and methods of the invention may be used in any of many other anatomical location in the body of the patient [0156] one place. 例如，在一些实施方案中，本发明的柔性组织改变装置可以用于下述部位的微创手术：肩、肘、 腕、手、髋、膝、足、踝、其它关节或体内的其它解剖学位置。 For example, in some embodiments, the present invention is the flexible tissue changing means may be used for the following parts of the minimally invasive surgery: the shoulder, elbow, wrist, hand, hip, knee, foot, ankle, or other anatomical joints other vivo position. 类似地，尽管一些实施方案可以用于去除或以其它方式改变脊柱中的黄韧带和/或骨，以治疗椎管狭窄，在替代实施方案中，可以改变其它组织来治疗许多其它病症中的任一种。 Similarly, although some embodiments may be used to remove or otherwise modify the ligamentum flavum in the spine and / or bone to treat spinal stenosis, in an alternative embodiment, it may be changed to any other tissue to treat many other disorders one kind. 例如，在不同的实施方案中，治疗的组织可以包括但不限于：韧带、腱、骨、肿瘤、囊肿、软骨、疤痕、骨赘、炎性组织等。 For example, in various embodiments, the tissue treatment may include but are not limited to: ligaments, tendons, bone, tumors, cysts, cartilage, scars, osteophytes, inflammatory tissue and the like. 在一些实施方案中，非靶组织可以包括神经组织和/或神经血管组织，或者在其它实施方案中，非靶组织可以包括许多其它组织和/或结构中的任一种。 In some embodiments, the non-target tissue may include nervous tissue and / or neurovascular tissue, or in other embodiments, non-target tissue may include many other tissues and / or any structure. 因而，本文所述的不同实施方案可以用于在体内的许多解剖学位置中的任一处，改变许多不同组织中的任一种，以治疗许多不同病症中的任一种。 Thus, various embodiments described herein may be used at any of a number of anatomical location inside a body, changing any of a number of different tissues, for the treatment of any of a number of different disorders.
[0157] 本文包括的实施例和图解，作为例证且非限制性地，显示了可以实践所述主题的具体实施方案。 [0157] Examples included herein and illustrated embodiments, by way of illustration and not limitation, embodiment shows a specific embodiment of the subject matter may be practiced. 可以利用其它实施方案并从它们衍生出其它实施方案，从而可以做出结构的和逻辑的置换和变化，而不脱离本公开内容的范围。 Other embodiments may be utilized and derived from the other embodiments thereof, variations and substitutions can be made and the logical structure, without departing from the scope of the present disclosure. 可以在本文中用术语“发明”单个地或共同地提及本发明的主题的这样的实施方案，这仅仅为了方便，无意自发地限制本申请的范围为任何单一发明或发明构思（如果实际上公开了超过一个）。 May be used herein, the term "invention" referred to individually or collectively subject of the present invention such an embodiment, this is merely for convenience and are not intended to limit the scope of the present disclosure spontaneously to any single invention or inventive concept (if in fact the It discloses more than one). 因而，尽管本文已经例证和描述了具体实施方案，但适用于实现相同目的的任何方案可以用于替换显示的具体实施方案。 Accordingly, although illustrated and described herein have been described particular embodiments, but applicable to any achieve the same purpose may be used in alternative particular embodiments shown. 本公开内容意图覆盖不同实施方案的任意和所有改变或变体。 The present disclosure is intended to cover any and all adaptations or variations of various embodiments. 通过回顾上面的描述，本领域技术人员会明白上述实施方案的组合，和本文没有具体描述的其它实施方案。 By reviewing the above description, one skilled in the art will understand that combinations of the above embodiments, and other embodiments not herein specifically described.
1. 一种双手控制的组织改变装置，其具有用于在患者中切割组织的组织改变区域，所述组织改变区域包括：一对柔性长形切割部件，其沿着所述组织改变区域的长度延伸，其中每个长形切割部件具有一定的厚度，且每个长形切割部件构造成在组织中切割分离的槽至大于所述切割部件的厚度的深度。 A hand control tissue changing means, in a tissue of a patient having a tissue cutting area is changed, changing the tissue region comprising: a pair of flexible elongate cutting member, which changes along the length of the region of tissue extends, wherein each of the elongate cutting member has a certain thickness, and each elongated groove cutting member configured to cut tissue isolated to a depth greater than the thickness of the cutting member.
2.根据权利要求1所述的装置，其另外包括在所述装置的组织改变区域远侧的导丝联接器。 2. The apparatus according to claim 1, which further comprises changing a distal region of the guidewire coupling device in the tissue.
3.根据权利要求2所述的装置，其中所述导丝联接器构造成联接至导丝，且其中所述组织改变区域构造成由近端手柄和导丝致动。 3. The apparatus according to claim 2, wherein said guide wire coupler configured to be coupled to the guide wire, and wherein the tissue change region is configured to be actuated by a handle and the proximal end of the guidewire.
4.根据权利要求1所述的装置，其中所述组织改变区域构造成由近端手柄和远端手柄致动。 4. The apparatus according to claim 1, wherein the tissue change region is configured to be actuated by a handle proximal end and a distal end of the handle.
5.根据权利要求2所述的装置，其中所述导丝联接器构造成，使得所述装置可移去地连接至导丝的近端端部区域，因而通过牵拉导丝，能够拉动组织改变区域就位，而所述导丝的近端端部区域被导丝联接器保持相对于所述装置静止。 5. The apparatus according to claim 2, wherein said guide wire coupler configured so that removably connected to the proximal end region of said guidewire device, thereby pulling the guide wire through, to pull tissue change region in place, while the proximal region of the guidewire is held stationary with respect to said guide wire means coupling.
6.根据权利要求1所述的装置，其另外包括在组织改变装置的远端端部处的柔性引导器，其中所述引导器构造成，使得通过牵拉引导器，能够拉动组织改变区域就位。 6. The apparatus according to claim 1, further comprising a flexible guide tissue modifier at the distal end of the device, wherein the guide is configured such that by pulling the guide, it is possible to pull the tissue change region bit.
7.根据权利要求1所述的装置，其中至少一个切割部件包括切割丝。 7. The device according to claim 1, wherein the at least one cutting element comprises a cutting wire.
8.根据权利要求1所述的装置，其中至少一个切割部件包括季格利丝。 8. The apparatus according to claim 1, wherein the at least one cutting element comprises a quaternary Geli Si.
9.根据权利要求1所述的装置，其中至少一个切割部件包括长形丝，所述长形丝具有沿着该丝的长度的螺旋形切割边缘。 9. The apparatus according to claim 1, wherein the at least one cutting member comprises an elongate wire, the elongate wire having a helical cut along the length of the wire edge.
10.根据权利要求1所述的装置，其中至少一个切割部件包括长形缆索，所述长形缆索具有沿着所述缆索的长度分布的刀刃。 10. The apparatus according to claim 1, wherein the at least one cutting member comprises an elongate cable, said cable having elongated cutting edges distributed along the length of the cable.
11.根据权利要求1所述的装置，其另外包括联接至所述组织改变区域的长形切割部件上的隔离件，其中所述隔离件形成合适的尺寸并构造成将各切割部件暂时保持为彼此相距一定距离。 11. The apparatus according to claim 1, further comprising a separator coupled to the tissue changes elongate member region cutting member, wherein said spacer member is formed of suitable size and configured to temporarily keep the respective cutting member distance from each other.
12.根据权利要求11所述的装置，其中所述隔离件包括长形柔性的、条带形基质。 12. The apparatus according to claim 11, wherein said spacer member comprises an elongated flexible strip-shaped substrate.
13.根据权利要求12所述的装置，其中所述隔离件另外包括联接器，所述联接器朝向所述隔离件的外缘区域，并构造成将切割部件暂时固定至所述隔离件的外缘区域。 13. The external apparatus as claimed in claim 12, wherein said spacer member further comprises a coupling, said coupling region of the outer edge of the spacer member, and a cutting member configured to temporarily fix the spacer edge region.
14.根据权利要求11所述的装置，其中所述隔离件形成合适的尺寸并构造成沿着所述长形切割部件的长度滑动。 14. The apparatus according to claim 11, wherein said spacer member is formed of suitable size and configured to slide along the length of the elongate cutting member.
15.根据权利要求1所述的装置，其另外包括多个柔性连接的横档，其中每个横档至少部分地跨所述装置的宽度延伸。 15. The apparatus according to claim 1, further comprising a plurality of flexible connection of rungs, wherein the width of each cross-profile is at least partially extends across the device.
16.根据权利要求15所述的装置，其中所述横档是在所述装置的组织改变区域的近端禾口远端。 16. The apparatus according to claim 15, wherein said crosspiece is changed Wo proximal port distal region of the device in the tissue.
17.根据权利要求15所述的装置，其另外包括连接件，所述连接件连接邻近的横档。 17. The apparatus according to claim 15, which further comprises a connecting member, said connecting member connecting adjacent rungs.
18.根据权利要求17所述的装置，其中所述连接件包括至少一条缆索。 18. The apparatus according to claim 17, wherein said connecting member comprises at least one cable.
19.根据权利要求18所述的装置，其中所述缆索包括第一长形切割部件和第二长形切割部件。 19. The apparatus according to claim 18, wherein said cable comprises a first elongate member and a second elongate cutting member cutting.
20. 一种长形的双手控制的组织改变装置，其用于在患者中切割组织，所述装置包括：一对柔性的长形切割部件，所述一对柔性的长形切割部件沿着所述装置的长形长度延伸；和隔离件，其中所述隔离件形成合适的尺寸并构造成以如下两种模式之一操作：第一模式，其中所述隔离件被联接至所述切割部件，使得其保持2个切割部件中的每一个的一部分彼此相距一定距离；和第二模式，其中所述隔离件的至少一部分移动离开切割部件，以允许切割部件更深入地切入组织。 20. An elongated tissue hand control changing means for cutting tissue in a patient, the apparatus comprising: a pair of flexible elongate cutting member of the pair of flexible elongate cutting member along a the length of said elongated means extends; and a spacer, wherein said spacer member is formed to an appropriate size and configured in one of two modes: a first mode wherein said spacer member is coupled to the cutting member, such that it holds a part of each of the two cutting member in distance from each other; and a second mode, wherein moving at least a portion of said spacer member away from the cutting element to allow the cutting member to cut deeper tissue.
21.根据权利要求20所述的装置，其中所述长形切割部件彼此基本上平行。 21. The apparatus according to claim 20, wherein the elongated cutting member are substantially parallel to each other.
22.根据权利要求20所述的装置，其中处于第二模式的隔离件位于所述切割部件的平面以外。 22. The apparatus according to claim 20, wherein the second mode is outside the plane of the spacer member positioned cutting member.
23.根据权利要求20所述的装置，其另外包括导丝联接器，所述导丝联接器位于所述组织改变装置的远端端部区域处。 23. The apparatus according to claim 20, which further comprises a guidewire coupling, the guide wire coupling the tissue located at the distal end region changing means.
24.根据权利要求20所述的装置，其中处于第二模式的隔离件被设置成，使得所述切割部件中的每一个能够切入组织中的深度大于所述切割部件的厚度。 24. The apparatus according to claim 20, wherein the spacer member is in the second mode is arranged such that each of the cutting member can cut the tissue thickness greater than the depth of the cutting member.
25.根据权利要求20所述的装置，其中所述隔离件另外包括联接器，所述联接器构造成，当所述隔离件处于第一模式时，将隔离件联接至切割部件上。 25. The apparatus according to claim 20, wherein said spacer member further comprises a coupler, the coupler is configured to, when the spacer is in the first mode, the spacer member is coupled to the cutting member.
26.根据权利要求25所述的装置，其中随着所述切割部件切穿联接器，所述隔离件从第一模式转换为第二模式。 26. The apparatus according to claim 25, wherein as the cut through the cutting member coupling the spacer member from a first mode to a second mode.
27.根据权利要求25所述的装置，其中随着联接器沿着所述长形切割部件的长度滑动，所述隔离件从第一模式转换为第二模式。 27. The apparatus according to claim 25, wherein as the coupling along the length of the elongate cutting member slides, said separator member from a first mode to a second mode.
28.根据权利要求25所述的装置，其中所述联接器包括可变形材料，所述可变形材料形成合适的尺寸并构造成，随着可变形材料变形和隔离件的一部分相对于切割部件运动， 所述隔离件从第一模式转换为第二模式。 28. The apparatus according to claim 25, wherein said coupler comprises a deformable material, the deformable material to form a suitable sized and configured, as a portion of deformable material and the spacer element for movement of the cutting member the spacer member from a first mode to a second mode.
29.根据权利要求20所述的装置，其另外包括弹簧，其中所述弹簧构造成，随着所述隔离件从第一模式转换为第二模式而伸展。 29. The apparatus according to claim 20, further comprising a spring, wherein said spring is configured to, as the spacer member from a first mode to a second mode to stretch.
30.根据权利要求20所述的装置，其中所述切割部件形成合适的尺寸并构造成，在所述隔离件处于第一模式时，在组织中切入第一深度，并在所述隔离件处于第二模式时，在组织中切入第二更大的深度。 30. The apparatus according to claim 20, wherein said cutting member is formed of suitable size and configured to, when the spacer member is in the first mode, the first depth of cut in the tissue, and in the spacer member when the second mode, the second cut into greater depth in the organization.
31.根据权利要求20所述的装置，其中所述切割部件构造成由近端手柄和远端手柄致动。 31. The apparatus according to claim 20, wherein said cutting member is configured to grip a proximal end and a distal handle actuator.
32.根据权利要求20所述的装置，其中所述切割部件构造成往复运动，其中所述切割部件构造成被远端手柄拉向远端，并构造成被近端手柄拉向近端。 32. The apparatus according to claim 20, wherein said cutting member is configured to reciprocate, wherein said cutting member is configured to be pulled toward the distal end of the distal end of the handle, and configured to be pulled toward the proximal end of the handle.
33. 一种改变组织的方法，所述方法包括：使长形柔性的组织改变装置至少部分地围绕靶组织穿过；通过从所述装置的至少一个末端牵拉所述组织改变装置，使所述装置的组织改变区域抵靠着靶组织运动；和使用一对沿着所述组织改变区域的长形长度延伸的柔性长形切割部件，在组织中切割2个分离的长形槽，其中所述长形切割部件具有厚度，且所述长形槽的每一个切入的深度大于切割部件的厚度。 33. A method of modifying tissue, the method comprising: an elongated flexible tissue modification device through the at least partially surrounds the target tissue; from at least one end by means of said drawing means changes said tissue, so that the said apparatus tissue change region against the target tissue motion; and a flexible elongate member with a pair of cut varies along the length of the tissue region extending elongate cut two separate elongated slots in the tissue, wherein said elongated cutting member having a thickness, and the depth of each of the cutting grooves is greater than the thickness of the elongated cutting member.
34.根据权利要求33所述的方法，其中所述长形槽各自具有大于Icm的深度。 34. The method according to claim 33, wherein said elongated slots each have a depth of greater than Icm.
35.根据权利要求33所述的方法，其中所述长形槽各自具有大于2cm的深度。 35. The method according to claim 33, wherein said elongated slots each have a depth of greater than 2cm.
36.根据权利要求33所述的方法，其中所述长形槽彼此基本上平行。 36. The method according to claim 33, wherein said elongated slot substantially parallel to each other.
37.根据权利要求33所述的方法，所述方法另外包括取出靶组织。 37. The method according to claim 33, the method further comprises withdrawing the target tissue.
38.根据权利要求33所述的方法，其中所述靶组织包括小关节的至少一部分。 38. The method according to claim 33, wherein the target tissue comprises at least a portion of a facet joint.
39.根据权利要求33所述的方法，其中所述使组织改变装置至少部分地围绕靶组织穿过的步骤包括：使导丝至少部分地围绕靶组织穿过，并使用导丝围绕靶组织牵拉柔性组织改变装置。 39. The method of claim 33, wherein said changing means tissue at least partially surrounding the step of passing the target tissue comprising: a guide wire at least partially through the tissue surrounding the target, using the target tissue retractor around guidewire pull the flexible tissue modification device.
40.根据权利要求33所述的方法，其中所述切割步骤包括：使用一对柔性长形切割部件，在组织中切割所述槽至第一深度，将所述柔性长形切割部件用隔离件保持为彼此相距一定距离；和用所述一对柔性长形切割部件在组织中切割所述槽至第二更大的深度。 40. The method according to claim 33, wherein said cutting step comprises: using a pair of flexible elongate cutting member, cutting tissue to a first depth of said grooves, the flexible elongate member with a cut separator is kept at a distance from each other; and a flexible elongate cutting member of the pair of cutting tissue in the slot to a second greater depth.
41.根据权利要求40所述的方法，所述方法另外包括：在切割所述槽至第二更大的深度之前，相对于所述切割部件移动所述隔离件。 41. The method according to claim 40, the method further comprising: prior to cutting the groove to a second greater depth, with respect to the cutting movement of the spacer member.
42.根据权利要求41所述的方法，所述方法另外包括：随着所述隔离件移动离开所述切割部件，用所述隔离件收集切割的组织。 42. The method of claim 41, the method further comprising: with said spacer member is moved away from the cutting means, with cutting the tissue collector isolation member.
43.根据权利要求33所述的方法，其中所述使组织改变装置抵靠着组织运动的步骤包括：向所述组织改变装置的近端端部和远端端部两者施加张力，以抵靠着组织驱动所述组织改变装置。 43. The method according to claim 33, wherein the tissue against the changing means comprises the step of moving tissue: both the proximal and distal ends of the device applies tension to the tissue changes to abut tissue against the tissue modification device driver.
44.根据权利要求33所述的方法，所述方法另外包括：在切割槽的同时，用所述切割部件中的至少一个切穿联接器，其中所述联接器将隔离件联接至所述切割部件上。 44. The method according to claim 33, the method further comprising: simultaneously cutting groove, the cutting member with at least one cut through coupling, wherein the coupling member is coupled to the spacer the cutting member.
45.根据权利要求33所述的方法，所述方法另外包括：在组织中切割槽的同时，使所述切割部件中的至少一个脱离联接器，其中所述联接器将隔离件联接至所述切割部件上。 45. The method according to claim 33, the method further comprising: simultaneous cutting of grooves in the tissue from at least one coupling member of the cutting, wherein said coupling member is coupled to the isolating cutting member.
46.根据权利要求33所述的方法，其中所述切割步骤另外包括：通过用远端手柄向远侧牵拉所述组织改变区域，并通过用近端手柄向近侧牵拉所述组织改变区域，使所述装置的所述组织改变区域抵靠着靶组织往复运动。 46. ​​The method according to claim 33, wherein said cutting step further comprises: pulling distally through the tissue with the distal end of the handle to change the area, and the tissue is changed by pulling proximally with the proximal end of the handle region, the region changing means of the tissue against the target tissue to reciprocate.
CN 201080026422 2009-05-04 2010-05-04 Tissue modification devices and methods CN102458273B (en)
US17532309 true 2009-05-04 2009-05-04
US61/175,323 2009-05-04
US25463809 true 2009-10-23 2009-10-23
US61/254,638 2009-10-23
US28518809 true 2009-12-10 2009-12-10
US61/285,188 2009-12-10
PCT/US2010/033508 WO2010129525A3 (en) 2009-05-04 2010-05-04 Tissue modification devices and methods
CN102458273A true true CN102458273A (en) 2012-05-16
CN102458273B CN102458273B (en) 2014-08-27
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CN 201080026422 CN102458273B (en) 2009-05-04 2010-05-04 Tissue modification devices and methods
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