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Publication numberCN105163689 A
Publication typeApplication
Application numberCN 201480015307
PCT numberPCT/US2014/021266
Publication date16 Dec 2015
Filing date6 Mar 2014
Priority date14 Mar 2013
Also published asEP2967898A1, EP2967898B1, US9585761, US20140277465, US20170119535, WO2014158982A1
Publication number201480015307.7, CN 105163689 A, CN 105163689A, CN 201480015307, CN-A-105163689, CN105163689 A, CN105163689A, CN201480015307, CN201480015307.7, PCT/2014/21266, PCT/US/14/021266, PCT/US/14/21266, PCT/US/2014/021266, PCT/US/2014/21266, PCT/US14/021266, PCT/US14/21266, PCT/US14021266, PCT/US1421266, PCT/US2014/021266, PCT/US2014/21266, PCT/US2014021266, PCT/US201421266
InventorsJ.泰森, J.里希特, M.维泽尔曼, B.昆特, S.A.米勒
Applicant德普伊新特斯产品公司
Export CitationBiBTeX, EndNote, RefMan
External Links: SIPO, Espacenet
Angulated rings and bonded foils for use with balloons for fusion and dynamic stabilization
CN 105163689 A
Abstract
The present invention provides an inflatable and implantable balloon (10) for treatment of degenerative disc disease, bones, lesions, spinal deformities and spinal motion segment instabilities. The balloon is comprised of adjustable and expandable volumes (10A,10B,10C). The present inventionalso discloses methods of forming, inserting, expanding, and implanting the multi-volume balloon (10) for proper placement and stabilization of the spinal lesion or disease. Still further disclosed are kits for aligning and stabilizing elements of the spine.
Claims(25)  translated from Chinese
1.一种多空间球囊,所述多空间球囊用于治疗椎间盘退变疾病、椎体骨质缺损、以及脊柱运动节段不稳的临床后果,所述多空间球囊包括多个单空间,每个单空间彼此直接或间接连接,其中穿孔部位位于至少两个所述单空间之间,并且其中每个单空间各自可调节和可膨胀使得(a)每个单空间可包含不同量的内容物,并且(b)多个单空间中的每一个可包含相对于另一个单空间相同或不同量和类型的内容物。 A multi-space balloon, the balloon for the treatment of multiple spatial degenerative disc disease, vertebral bone defect, and clinical consequences unstable spinal motion segment, the balloon includes a plurality of multi-space space, every single space directly or indirectly connected to each other, wherein the puncture site is located between two of said at least a single space, and wherein each respective single space adjustable and expandable so that (a) every single space may contain different amounts contents, and (b) each of the plurality of single spaces may comprise a single space with respect to another identical or different amounts and types of content.
2.根据权利要求1所述的多空间球囊,其中所述穿孔部位包含导丝。 2. The multiplexer according to claim 1 wherein the balloon space, wherein the guide wire comprises perforated portions.
3.根据权利要求1所述的多空间球囊,其中所述单空间为至少二片薄片在所述穿孔部位结合在一起形成的隔室,其中所述结合选自:超声焊接、使用光源的热焊接、使用热源的热焊接、压焊、型锻、连接、胶粘和缝合。 3. The multi cannula was claim, wherein said space is at least two single sheet bonded to the perforated portions together to form a compartment, wherein the combination is selected from: ultrasonic welding, using a light source heat welding, using a heat source of heat welding, pressure welding, swaging, connections, gluing and stitching.
4.根据权利要求1所述的多空间球囊,其中所述材料选自:薄片、网、管、硅橡胶、弹性橡胶、聚醚醚酮(或PEEK)、聚醚酮酮(或PEKK)、聚乙烯(或PE)、对苯二甲酸(或PET)、聚氨酯(或PU)、热塑性聚氨酯(或TPU)和聚碳酸酯聚氨酯(或PCU)。 4. A multiplexer according to claim 1, wherein the space balloon, wherein the material is selected from: sheets, nets, tubes, silicone rubber, elastic rubber, polyether ether ketone (or PEEK), polyether ketone ketone (or of PEKK) , PE (PE), terephthalic acid (or PET), polyurethane (or PU), thermoplastic polyurethane (or TPU) and polycarbonate polyurethane (or PCU).
5.一种球囊,所述球囊用于治疗椎间盘退变疾病、椎体骨质缺损、以及脊柱运动节段不稳的临床后果,所述球囊包括结合在一起以形成球囊的至少二片材料,其中所述材料包含标记,其中所述标记可结合在一起以在所述球囊中形成至少两个隔室。 A balloon, the balloon for the treatment of disc disease, vertebral bone defect, and clinical consequences of unstable spinal motion segment degeneration, including the balloon bonded together to form at least a balloon two material, wherein said material comprises a label, wherein the marker may be joined together to form at least two compartments in the balloon.
6.根据权利要求5所述的球囊,其中所述球囊由至少三片结合在一起的材料形成。 6. The balloon according to claim 5, wherein the balloon material is comprised of at least three are formed together.
7.根据权利要求5所述的球囊,其中所述材料选自:薄片、网、织物、管、硅橡胶、弹性橡胶、聚醚醚酮(或PEEK)、聚醚酮酮(或PEKK)、聚乙烯(或PE)、对苯二甲酸(或PET)、聚氨酯(或PU)、热塑性聚氨酯(或TPU)和聚碳酸酯聚氨酯(或PCU)。 7. A balloon according to claim 5, wherein said material is selected from: a sheet, net, fabric, tubes, silicone rubber, elastic rubber, polyether ether ketone (or PEEK), polyether ketone ketone (or of PEKK) , PE (PE), terephthalic acid (or PET), polyurethane (or PU), thermoplastic polyurethane (or TPU) and polycarbonate polyurethane (or PCU).
8.根据权利要求5所述的球囊,其中所述至少两个隔室各自可调节和可膨胀使得(a)每个隔室可包含不同体积的内容物,并且(b)隔室中的每个可包含相对于另一个隔室相同或不同体积的内容物。 8. A balloon according to claim 5, wherein each of said at least two compartments can be adjusted such that expandable and (a) each of the compartments may contain different volumes of contents, and (b) in the compartment each may contain another compartment with respect to the same or different volumes of contents.
9.根据权利要求5所述的方法,其中所述材料包括电路板,所述电路板包含印刷的黑色标记,其中所述标记在暴露在发热光下时结合在一起。 9. The method according to claim 5, wherein said material comprises a circuit board, said printed circuit board comprises a black marker, wherein the marker is exposed to the combined heat when light.
10.一种调整单空间球囊角度以创建多空间球囊的方法,所述方法包括: 提供单空间球囊; 提供至少一个环,其中所述环具有两端,并且所述环的两端设置成预定角度; 将所述单空间球囊插入所述环中; 将包含所述单空间球囊的环插入脊柱腔中,其中所述腔选自椎间盘间隙和椎体中间隙;以及使所述单空间球囊膨胀,其中所述单空间球囊在所述环内的膨胀形成多空间球囊,其中所述环的预定角度决定所述多空间球囊的每个空间的成角。 10. A method of adjusting the angle of a single space balloon to create more space balloon, the method comprising: providing a single space balloon; providing at least one ring, wherein the ring has two ends, and both ends of the ring disposed at a predetermined angle; said cannula was inserted into the single ring; single space comprising the balloon ring into spinal cavity, wherein said cavity is selected from the intervertebral disc space and vertebral body clearance; and so that the said single space balloon is inflated, wherein the balloon is inflated in a single space formed within the ring-space balloon, wherein said predetermined angle is decided angled ring each of said multiple spatial space balloon.
11.根据权利要求10所述的方法,所述方法还包括决定通过膨胀和形成所述多空间球囊对所述脊柱进行校正。 11. The method according to claim 10, wherein the method further comprises the decision by the expansion and the formation of the multi-space balloon on the spine is corrected.
12.根据权利要求10所述的方法,所述方法还包括将所述环结合至所述多空间球囊,其中所述结合选自:超声焊接、使用光源的热焊接、使用热源的热焊接、压焊、型锻、连接、胶粘和缝合。 12. The method according to claim 10, wherein the method further comprises the multi-ring binding to the space balloon, wherein the combination is selected from: ultrasonic welding, heat welding light source is used, the heat welding using a heat source , pressure welding, swaging, connections, gluing and stitching.
13.一种脊柱校准和稳定方法,所述方法包括: 将包含多空间球囊的球囊导管插入脊柱腔中,其中所述多空间球囊位于所述球囊导管的远端处,其中所述腔选自椎间盘间隙和椎体中间隙; 通过插入流体来膨胀所述多空间球囊的第一空间,其中所述第一空间的膨胀恢复至所述脊柱的高度;以及通过插入固化材料来膨胀所述多空间球囊的第二空间,其中插入后所述固化材料硬化以维持通过所述第一空间的膨胀而创建的高度恢复。 13. A spinal stabilization and calibration, the method comprising: containing multiple cannula was inserted into the spine of a balloon catheter lumen, wherein the multi-balloon space at the distal end of the balloon catheter, wherein said cavity is selected from the vertebral body and intervertebral disc space gap; space by inserting a first fluid to inflate the balloon more space, wherein the first expansion space to restore the height of the spine; and by inserting curable material expanding said second balloon more space space, wherein said curable material to harden after insertion to maintain a high degree of recovery by the expansion of the first space created.
14.根据权利要求13所述的方法,其中所述流体选自:水、盐溶液、对比剂溶液和凝胶。 14. The method according to claim 13, wherein said fluid is selected from: water, saline, contrast media solutions and gels.
15.根据权利要求13所述的方法,其中所述固化材料选自:聚合物、结晶固体、弹性体和玻璃。 15. The method according to claim 13, wherein the curable material is selected from: polymers, crystalline solid, elastomers and glass.
16.根据权利要求13所述的方法,其中所述多空间球囊包含穿孔部位,并且所述穿孔部位包含导丝以促进拆除所述多空间球囊的至少一个空间。 16. The method according to claim 13, wherein the balloon comprises multiple perforations space portion, and the perforated portion comprises at least a guidewire to facilitate removal of said multiple spatial space balloon.
17.根据权利要求16所述的方法,还包括: 在将所述多空间球囊的第二空间充胀后,沿着所述穿孔部位撕开以移除所述第一空间; 从所述脊柱的腔收缩并且移除所述第一空间;以及保持所述多空间球囊的第二空间,所述多空间球囊包含所述硬化的聚合物以维持通过所述第一空间的膨胀而创建的高度恢复。 17. The method according to claim 16, further comprising: after the second space in the multi-space balloon is inflated, tearing along the perforated portions to remove said first space; from the spinal shrinkage cavity and removing the first space; and a second space holding said multi-space balloon, the space balloon contains the hardened multi-polymer is maintained by the expansion of said first space and create height restoration.
18.根据权利要求13所述的方法,其中所述第一空间和第二空间膨胀至不同高度。 18. The method according to claim 13, wherein said first and second spaces expanded to different heights.
19.根据权利要求18所述的方法,其中所述第一空间的膨胀也提供缓冲效应,并且其中所述第一空间膨胀至比所述第二空间高的高度。 19. The method according to claim 18, wherein the first expansion space also provides cushioning effect, and wherein the first space is expanded to higher than the height of the second space.
20.一种用于将球囊插入患者的腔中的方法,所述方法包括: 将所述球囊卷成管状形状; 将所述球囊插入所述患者的腔中,其中所述腔在所述球囊插入前被清洗;以及一旦在所述腔内就展开所述球囊。 20. A balloon into a patient's chamber method, said method comprising: said balloon rolled into a tubular shape; balloon inserted into the cavity of said patient, wherein said cavity before the balloon is inserted to be cleaned; and once in the chamber to expand the balloon.
21.根据权利要求20所述的方法,其中所述球囊具有在将所述球囊卷成所述管状形状之前选择的形状。 21. The method according to claim 20, wherein said balloon has a tubular shape prior to the selection of the shape of the rolled balloon.
22.根据权利要求20所述的方法,其中所述球囊围绕导丝卷成管状形状。 22. The method according to claim 20, wherein said balloon around a guidewire rolled into a tubular shape.
23.根据权利要求20所述的方法,其中所述球囊通过盖套插入所述腔中。 23. The method according to claim 20, wherein said balloon is inserted through the sleeve cap cavity.
24.根据权利要求20所述的方法,所述方法还包括在所述球囊插入所述腔中后将所述球囊充胀,其中将所述球囊充胀恢复所述腔的适当结构。 Suitable structure 24. The method according to claim 20, the method further comprising the balloon inserted into the cavity after the balloon is inflated, wherein the balloon is inflated to restore the chamber .
25.一种用于校准和稳定骨的套件,所述套件包括: 至少一个单空间球囊;以及至少一个环,其中每个环具有两端,所述环的端设置成预定角度,所述单空间球囊被插入所述环中,其中将包含所述环的单空间球囊充胀来创建多空间球囊,并且所述环的预定角度确定所述多空间球囊的每个空间的成角。 25. A kit for calibration and stabilization of the bone, said kit comprising: at least one single-balloon space; and at least one ring, wherein each ring having two ends, the ends of the ring set to a predetermined angle, the single-space balloon is inserted into the ring, each of which will contain a single space of the ring space balloon inflated balloon to create more space, and the predetermined angle of the ring is determined in the multi-space balloon angled.
Description  translated from Chinese
与融合和动态稳定球囊一起使用的成角环和结合薄片 Angled ring and the fusion and dynamic stabilization combined use with balloon sheet

技术领域 TECHNICAL FIELD

[0001] 本技术领域整体涉及用于治疗椎间盘退变疾病、骨损、脊柱畸形、以及脊柱运动节段不稳的多种可充胀和可植入球囊,更具体地,涉及多种可调球囊以及将可调球囊用在椎间盘间隙、椎体、棘突间、或任何脊椎元素内以便恢复脊柱的原始结构的方法。 [0001] The technical field relates generally used for the treatment of degenerative disc disease, bone loss, spinal deformity, and spinal motion segment instability and a variety of implantable inflatable balloon, and more particularly, to a variety of available adjust the balloon and the balloon with an adjustable gap between the disc, vertebral body, spinous process, or by any means within the spine element to restore the original structure of the spine.

背景技术 Background technique

[0002] 可膨胀医疗装置,例如球囊,通常用于扩张和疏通阻塞或变窄的动脉(血管成形术)。 [0002] The expandable medical device, such as a balloon, is typically used to expand and clear clogged or narrowed arteries (angioplasty). 最近,球囊常常用于血管成形术以外的手术环境,因为植入物能引入手术部位并且具有缩小的剖面以最小化对周围组织、神经、和血管的损伤。 Recently, frequently used in balloon angioplasty surgical environment outside of the implant can be introduced as the surgical site and has a reduced cross-section to minimize the surrounding tissue, nerves, and blood vessel damage.

[0003] 在椎骨重建的环境中,球囊可能尤为有用。 [0003] In the vertebral reconstruction environment, the balloon may be particularly useful. 椎骨重建手术,包括诸如椎体后凸成形术或椎体支架术等经皮手术,用于校正断裂椎骨、脊柱畸形、或脊柱不稳,而诸如开腹手术脊柱融合术等椎间手术用于校正退变或突出椎间盘造成的椎间盘高度损失。 Vertebra reconstructive surgery, including such as kyphoplasty or vertebral stenting and other percutaneous surgery for correcting vertebral fracture, spinal deformity, or spinal instability, such as open surgery and spine surgery for interbody fusion, etc. correction disc degeneration or herniated disc caused by loss of altitude. 现在尚不知道使用球囊的经皮手术通常用于脊柱融合和椎间盘置换手术。 It is not yet known to use balloon percutaneous spinal fusion surgery is usually used and disc replacement surgery. 尽管包含巨大开放性伤口和随后的手术创伤,传统的脊柱融合手术常常对恢复适当的椎间距有效,并且因此减轻对神经的压迫和随之而来的疼痛。 Despite containing a huge open wound and subsequent surgical trauma, traditional spinal fusion surgery often to restore proper vertebral spacing effective, and thus relieve pressure on the nerve and consequent pain.

[0004] 当两个椎体融合在一起时,当前使用的融合手术出现了问题,因为最后两个融合的椎体之间缺少一个椎间盘使相邻椎间盘超负荷,这加剧了这些相邻椎间盘的退变。 [0004] When the two vertebrae together, the current use of fusion surgery there is a problem, because of the lack of integration between the last two vertebrae adjacent a disc so that the disc overload, which exacerbates these adjacent disc degeneration. 一种治疗方案是椎间盘置换,诸如人工椎间盘。 Disc replacement is a treatment program, such as artificial disc. 这种手术也用于椎间盘退变或突出的患者。 This procedure is also used in patients with disc degeneration or prominent. 与人工椎间盘相关的一个问题是椎体在不同的位置可能需要不同的支撑。 One problem associated with the artificial disc is the vertebral body may require different support in different locations. 由于通常发生在考虑进行手术之前的多年脊柱损伤,损伤的椎间盘上的压力分布可不再统一。 Because usually occurs in the years before considering surgery spinal injury, the pressure distribution on the disc injury can no longer unified. 因此,人工椎间盘可不向椎体提供必要的支撑。 Thus, the artificial disc may not provide the necessary support to the vertebral body.

[0005] 与使用植入物相关的另一个问题是诸如椎间盘退变疾病(DDD)等疾病为动态疾病:椎间盘逐渐地退变并且出现多种症状,因此存在多种治疗方案。 [0005] Another problem associated with the use of an implant such as a disc degeneration disease (DDD) is a dynamic disease and other diseases: disc degeneration and progressively more symptoms appeared, so there are several treatment options. 椎间盘退变是老化过程中的正常部分,对于正常人而言可能不是问题。 Disc degeneration is a normal part of the aging process, for the normal person may not be a problem. 然而,对于患有DDD的个人,退变的椎间盘能带来严重慢性疼痛,并且如果不治疗,将导致慢性虚弱病状。 However, for individuals with DDD, degenerative discs can bring severe chronic pain, and if left untreated, would lead to chronic weak condition. 对于一些患者,DDD能够不进行手术治疗,但是如果非手术治疗方案不成功,通常建议手术。 For some patients, DDD can not be treated with surgery, but if the non-surgical treatment is not successful, surgery is usually recommended. 患者选择手术方案取决于椎间盘退变阶段,例如,早期、中期、或晚期退变阶段。 Patients choose surgery program depends on the stage of intervertebral disc degeneration, for example, early, middle or late stages of degeneration. 外科手术的一些例子包括:椎间盘切除术、椎体切除术、融合术、动态稳定术、椎间盘关节成形术(也称为人工椎间盘置换术(ADR))、以及椎管减压术。 Some examples include surgery: discectomy, corpectomy, fusion, dynamic stabilization surgery, intervertebral disc arthroplasty (also called artificial disc replacement (ADR)), as well as spinal decompression. 一旦传统外科手术,诸如融合术,用于治疗DDD,对于患者来说增加再手术以治疗DDD相关其他问题的几率。 Once the traditional surgery, such as fusion, for the treatment of DDD, reoperation increase for patients with other issues related to the treatment of DDD chance. 这个问题的一个解决方案是提供允许患者保持移动性并且保持运动范围以最小化再手术需要的一种DDD治疗方法。 A solution to this problem is to provide mobility and allow patients to maintain range of motion in order to maintain a minimum one kind DDD treatment of the required reoperation.

[0006] 如相关领域技术人员将容易理解的,存在对新的和创新的针对病变和损伤骨以及椎间盘治疗的可膨胀医用植入物和插入装置的持续需要。 [0006] As the relevant skill in the art will readily appreciate, there is a continuing need for new and innovative for disease and damage bone and intervertebral disc treatment expandable medical implant and insertion device. 更具体地,存在对多种可膨胀医用植入物的需要以为骨腔和/或椎间盘间隙内定位提供最大支撑和便利。 More specifically, there is a variety of expandable medical implant requires that the bone cavity and / or locate the disc space to provide maximum support and convenience.

发明内容 SUMMARY

[0007] 为了满足这些和其他需要,并且考虑到其目的,本发明公开内容提供了一种多空间球囊以治疗椎间盘退变疾病、椎体骨质缺损、脊柱运动节段不稳的临床后果。 [0007] In order to meet these and other needs, and in view of its object, the present disclosure provides a multi-space balloon to treat degenerative disc disease, vertebral bone defects, spinal motion segment instability clinical consequences . 球囊具有多个单空间。 The balloon having a plurality of single space. 每个单空间直接或间接地彼此连接,并且至少两个单空间之间包含有一个穿孔部位。 Each single space directly or indirectly connected to each other, and at least one perforated portion includes a single space between the two. 每个单空间单独可调节和可膨胀使得(a)每个单空间能包含不同体积的内容物;并且(b)多个单空间中的每一个能包含相对于另一个单空间相同或不同量和类型的内容物。 Each single spatial individually adjustable and expandable such that (a) each unit space can contain different volumes of contents; and (b) each of the plurality of single space can contain a single space with respect to another identical or different amounts and the type of contents.

[0008] 另一个实施例的球囊具有结合在一起形成球囊的至少二片材料。 [0008] Another embodiment of the balloon of the balloon is formed having a combination of at least two materials. 球囊材料包含标记;标记能结合在一起以在球囊上形成至少两个隔室。 Balloon material comprises a tag; tag can be combined together to form at least two on the balloon compartments.

[0009] 本发明也提供了治疗椎间盘退变疾病、椎体骨质缺损、脊柱运动节段不稳的临床后果的若干方法。 [0009] The present invention also provides a method of treating degenerative disc disease, vertebral bone defects, several methods of spinal motion segment instability clinical consequences. 在一个实施例中,该方法涉及调整单空间球囊的角度以创建多空间球囊。 In one embodiment, the method involves a single space to adjust the angle of the balloon to create more space balloon. 更具体地,该方法包括提供单空间球囊和至少一个环的步骤。 More specifically, the method includes providing a single space balloon and steps at least one ring. 该环具有两端,并且环的两端设置成预定的角度。 The ring has two ends, and both ends of the ring is set to a predetermined angle. 将单空间球囊插入环中。 The single-space balloon inserted into the ring. 将包含单空间球囊的环插入脊柱腔中,其中该腔为椎间盘间隙或椎体。 The ring contains a single space balloon is inserted into the spinal cavity, wherein the cavity of the intervertebral disc space or vertebral bodies. 膨胀该单空间球囊,其中单空间球囊在环内的膨胀形成多空间球囊,其中环的预定角度决定多空间球囊的每个空间的成角。 The single balloon expandable space, in which a single space balloon is inflated within the ring formed more space balloon, wherein the predetermined angle is determined angled ring of each space more space balloon.

[0010] 另一个实施例的方法涉及校准和稳定脊柱。 [0010] Another embodiment relates to calibrate and stabilize the spine. 该方法包括将包含多空间球囊的球囊导管插入脊柱腔的步骤,其中多空间球囊位于该球囊导管的远端处,该腔为椎间盘间隙或椎体。 The method comprises the steps comprising multiple balloon catheter cannula was inserted into the spinal cavity, wherein the multi-balloon space at the distal end of the balloon catheter, the lumen of the disc space or vertebral body. 通过插入流体膨胀该多空间球囊的第一空间,其中第一空间的膨胀恢复至脊柱的高度。 Expanding the balloon by inserting multiple spatial fluid in the first space, wherein a first expansion space is restored to the height of the spine. 通过插入固化材料膨胀该多空间球囊的第二空间,其中插入后该固化材料硬化以维持通过第一空间的膨胀而创建的高度恢复。 Expansion of the multi-space balloon is inserted through the second curable material space, which is inserted after the cured material to harden in order to maintain a high degree of recovery by the expansion of the first space created.

[0011] 又一个实施例的方法涉及将球囊插入患者的一个腔。 [0011] Yet another embodiment of the method relates to a balloon inserted into the cavity of the patient. 该方法包括将球囊卷成管状形状的步骤。 The method includes a balloon rolled into a tube shape steps. 然后将球囊插入患者的腔中,其中该腔在球囊插入前被清洗。 The balloon is then inserted into a patient's cavity, wherein the cavity is cleaned before balloon insertion. 一旦在腔内,展开球囊。 Once in the cavity, expand the balloon.

[0012] 本申请也提供了若干套件,其用于骨校准和稳定。 [0012] The present application also provides a number of kits for use in bone alignment and stability. 在一个实施例中,套件具有至少一个单空间球囊和至少一个环。 In one embodiment, a kit having at least one single-space balloon and at least one ring. 每个环具有两端。 Each ring has two ends. 环的两端设置成预定角度。 Set both ends of the ring at a predetermined angle. 当单空间球囊被插入环中时,将包含环的单空间球囊充胀来创建一个多空间球囊。 When the balloon is inserted into the space of a single ring, the ring contains a single space balloon is inflated to create a multi-space balloon. 环的预定角度确定多空间球囊的每个空间的成角。 Angled at a predetermined angle ring is determined more space balloon of each space.

[0013] 应当理解,以上一般性描述和以下详细描述对于本发明实施例均为示例性而非限制性。 [0013] It should be understood that both the foregoing general description and the following detailed description of the present invention are exemplary and not limiting embodiment.

附图说明 BRIEF DESCRIPTION

[0014] 在结合附图阅读时,能最好地理解以上发明内容以及以下对示例性实施例的详细说明。 [0014] when read with the accompanying drawings, can best be understood and the following detailed description of the contents of the exemplary embodiments of the invention above. 需要强调的是,根据惯例,附图的各种特征结构未按比例绘制。 It is emphasized that, according to established practice, the various features of the structure of the drawings are not to scale. 相反,为了清晰起见,各种特征结构的尺寸随意放大或缩小。 Instead, for clarity, the dimensions of various features of arbitrary configuration zoom in or out. 包括在附图中的是如下图形: Including in the drawings is a graphical follows:

[0015] 图1A、1B、1C、1D、1E、1F、1G、1H、11、1J、和IK示出根据一个实施例的用于从单空间球囊形成多空间球囊的套件的透视图; Perspective kit according to one embodiment for forming a multi-space balloon from a single space of the balloon of FIG. [0015] FIG. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 11,1J, and IK shown ;

[0016] 图2A和2B示出根据另一个实施例的单或多空间球囊的透视图; [0016] Figures 2A and 2B show a perspective view of a single balloon or multiple space according to another embodiment;

[0017] 图3示出根据另一个实施例的单或多空间球囊的透视图; [0017] Figure 3 shows a perspective view of the mono- or space to another embodiment of the balloon of FIG;

[0018] 图4A和4B是根据另一个实施例的多空间球囊的透视图;以及 [0018] FIG. 4A and 4B is a perspective view of a multi space balloon according to another embodiment; and

[0019] 图5A和5B是根据另一个实施例的多空间球囊的透视图。 [0019] FIG. 5A and 5B is a perspective view of the multi-space balloon of another embodiment of FIG.

具体实施方式 detailed description

[0020] 下列描述中所使用的某些术语仅为了方便起见且并非限制性的。 [0020] Some of the following terms used in the description for convenience only and are not restrictive. 词汇“右”、“左”、“下”和“上”指定附图中的方向,以此作为参照。 The word "right", "left", "lower" and "upper" specified directions in the drawings as a reference. 词汇“向内”和“向外”分别是指朝向和远离所述多空间球囊的几何中心的方向。 Words "inwardly" and "outwardly" will refer to directions toward and away from the geometric center of the multi-space of the balloon. 词汇“前”、“后”、“上”、“下”以及相关的词汇或短语指定人体中的优选位置和取向,以此作为参照而非旨在进行限制。 The term "front", "rear", "lower" and related words or phrases in body designated preferred position and orientation "on" as a reference and is not intended to be limiting. 所述术语包括以上列举的词汇、其派生词以及具有类似含义的词汇。 The terminology includes the above-listed words, derivatives thereof and words of similar import.

[0021] 能通过恢复至椎间盘的高度或通过稳定椎体治疗椎间盘退变疾病、椎体骨质缺损、以及脊柱运动节段不稳的临床后果。 [0021] through to restore disc height or treatment by stabilizing the vertebral disc degeneration disease, vertebral bone defect, and clinical consequences unstable spinal motion segment. 治疗针对脊柱内的病灶区“腔”。 Treatment for lesions in the spine, "cavity." 腔可包括以前由椎间盘占据的间隙、椎体内的间隙、或以上二者。 Chamber may include a gap previously occupied by a disc, a gap within the vertebral body, or both. 球囊收回椎间盘间隙(即,球囊作为椎间盘垫片)和椎间盘本身;球囊定制以为恢复患者结构提供理想形状。 Balloon recover disc space (ie, the balloon as disc pads) and the disc itself; thought balloon customizable patient recovery structure provides the ideal shape. 球囊维持椎间盘垫片的减震作用,保护相邻节段。 Balloon damping effect to maintain the disc pads to protect the adjacent segment. 在一些实施例中,球囊能协助融合任意两个体,优选地,椎体。 In some embodiments, the balloon can assist in fusion of any two bodies, preferably the vertebral body.

[0022] 在一些实施例中,球囊是多空间球囊。 [0022] In some embodiments, the balloon is a balloon-Space. 多空间球囊稳定和融合椎体的方式的一个益处是外科医生或护理者能调整和指定多空间球囊的各个空间以提供脊柱腔内的最大稳定性,例如,由于更好的负载分布和用于优化脊椎再校准的推拿改善方案提升了稳定性,减少下陷风险。 Space balloon and more stable way vertebral fusion is a benefit of the physician or caregiver can adjust and specify each space more space balloon cavity to provide maximum stability of the spine, for example, due to better load distribution and massage is used to optimize the spine recalibration improvement program to enhance stability and reduce the risk of subsidence. 例如,如果退变的椎间盘导致椎体沿着患者身体左侧向下倾斜,支撑那个区域的多空间球囊的单个空间不需要与患者身体右侧的多空间球囊的单个空间一样充胀。 For example, if the result of vertebral disc degeneration along the left side of the patient's body downward, supporting a single space single space more space in that area of the balloon does not need much space to the right of the body of the patient as the balloon is inflated. 多空间球囊的实施例提供了来自多空间球囊的个性化、可变、以及可调空间支撑。 Example multi-space balloon provides a personalized space balloon from multiple, variable and adjustable space support. 另外,单空间球囊,例如,可在椎体中心(骨最脆弱的部分)提供支撑。 In addition, single-space balloon, for example, can provide support in the center of the vertebral body (bone most vulnerable part). 多空间球囊根据个性化提供支撑,但是能针对椎骨外围边缘支撑该骨最牢固的地方。 Multi-space balloon to provide support according to individual, but capable of supporting the most secure place for bone vertebrae peripheral edge.

[0023] 在其他实施例中,球囊,单空间球囊或多空间球囊,由结合或焊接在一起的至少二张薄片或网组成。 [0023] In other embodiments, the balloon, the space balloon or balloon single space, or by a combination of at least two welded together sheet or web components. 金属薄片或网可由金属、聚合物、或以下所讨论的任何其他材料制成。 It is made of metal foil or mesh, polymer, or any other material made discussed below. 结合过程或焊接过程可通过任何方法完成,诸如:超声焊接、使用热源或光源的热焊接、压焊(例如,通过使用夹子、钳子、卡盘、或热缩管)、型锻、连接、胶粘、以及缝合。 Binding process or the welding process can be completed by any method, such as: ultrasonic welding, using a heat source or sources of heat welding, pressure welding (for example, through the use of clamps, pliers, chuck, or heat shrink tubing), swaging, connection, plastic sticky, and suture. 术语“结合的”和“焊接的”在本文可互换使用。 The term "binding" and "welding" are used interchangeably herein. 使用诸如这些结合在一起的材料的益处是它提高球囊形状的灵活性。 Use of these materials together such benefits as the shape is that it improves the flexibility of the balloon. 在一些实施例中,球囊可由具有不同厚度的薄片和网状材料的组合组成。 In some embodiments, the balloon may have a combination of different composition and thickness of the sheet web material. 这种结构提供比现有技术中的球囊更优越的膨胀度、负载力、初次固定/相邻加强的渗透性、以及降解性。 This arrangement provides a degree of swelling than the prior art balloon superior loading capacity, primary fixation / permeability adjacent strengthening, and degradation.

[0024] 球囊可用于治疗具有足够大以容纳球囊的内部伤口或腔的任何骨或椎间盘。 [0024] The balloon may be used to treat large enough to accommodate a balloon having an internal cavity or a wound or any bone disc. 使用实施例的装置和方法进行解剖复位的合适候选物的骨的非限制性例子包括椎体、长骨髓腔、跟骨、以及胫骨平台。 Using the apparatus and method of this embodiment be suitable candidates for anatomic reduction of non-limiting examples include vertebral bone, long bone marrow cavity, calcaneal and tibial plateau. 可设计和改装球囊以容纳特定骨或椎间盘结构以及不同腔形,球囊可在这些或其他合适的大骨中制造。 Balloon can be designed and adapted to accommodate a particular bone or disc-shaped structure and the different chambers, the balloon can be manufactured in these or other suitable large bone.

[0025] 球囊的材料基于球囊的预期目的而选择。 [0025] Based on the intended purpose of the balloon material selected balloon. 例如,如果球囊空间中的一个用于通过占据椎间盘间隙举起椎体,或提供缓冲/减震效应,材料可更有弹性以允许需要时改变体积。 For example, if the balloon space for a lift vertebral disc space occupied by, or provide a buffer / damping effect, the material can be more flexible to allow for the time required to change the volume. 球囊也可由刚性或非弹性材料制成,例如,薄片或涂有保护材料的薄片。 The balloon may also be a rigid non-elastic material, e.g., a sheet or a sheet coated with a protective material. 球囊可为厚壁的,以在较长一段时间内(例如,超过举起椎体或椎间盘的时间内)容纳流体。 The thick-walled balloon to a longer period of time (e.g., over a time within the vertebral body or disc lift) containing fluid. 可设计和构造多空间球囊以安装并且在较长一段时间内保持在骨腔中。 It can be designed and constructed more space balloon to install and maintain a long period of time in the bone cavity. 为了提供膨胀性和/或稳定性,球囊可由任何合适材料制造,例如,薄片、网、硅橡胶、弹性橡胶、聚醚醚酮(或PEEK)、聚醚酮酮(或PEKK)、聚乙烯(或PE)、聚氨酯(或HJ)、聚碳酸酯聚氨酯(或PCU)、对苯二甲酸(或PET)、热塑性聚氨酯(或TPU)等。 In order to provide expansion and / or stability of the balloon may be of any suitable material, e.g., a sheet, a net, a silicone rubber, elastic rubber, polyether ether ketone (or PEEK), polyether ketone ketone (or of PEKK), polyethylene (or PE), polyurethane (or HJ), polycarbonate polyurethane (or PCU), terephthalic acid (or PET), thermoplastic polyurethane (or TPU) and the like. 优选多变聚合物集中的任何一种。 Preferably any volatile polymer concentration. 作临时使用的球囊材料可包括聚酰胺(或PA)及其共聚物,例如聚乙酰胺(或PEBA,Pebax),允许合适的球囊材料合规性调整。 For temporary use of the balloon material may include polyamide (or PA) and copolymers thereof, such as polyetherimide (or PEBA, Pebax), allow appropriate adjustment of the balloon material compliance. 在一些实施例中,球囊可为包含印刷的黑色标记的电路板,其中标记在暴露在发热光下时结合在一起;光仅被标记(或黑线)吸收,局部发热并且因此在那个部位结合,否则光被传输穿过基本上透明的球囊。 In some embodiments, the balloon may contain a black mark printed circuit board, wherein the marker is exposed to light when combined with heat; light only are marked (or black line) absorption, localized heating and thus that part binding, otherwise the light is transmitted through the substantially transparent balloon. 由更柔软更具弹性的物质制作的球囊更适合于校正负载分布,而更坚硬的球囊更适合于校准和间隙维持。 By a softer and more flexible material more suitable for making balloon correct load distribution, while the more rigid balloon is more suited to calibrate and maintain the gap. 在另一个实施例中,球囊可为生物可吸收的。 In another embodiment, the balloon may be bioabsorbable. 生物可吸收球囊材料可包括聚乳酸、镁合金成分等。 Bioabsorbable balloon material may comprise polylactic acid, magnesium alloy ingredients.

[0026] —旦填充,球囊允许留在椎间盘间隙或骨内一段规定时间或可能地无限期。 [0026] - Once filled, the balloon allowed to remain for a specified period of time or possibly indefinitely within the disc space or bone. 球囊留在骨内的持续时间可取决于所治疗骨的具体情况以及治疗所寻求的特定目标。 Balloon remain in the bone may depend on the duration of the specific circumstances of a particular target bone treatment and sought to be treated. 当球囊植入很短一段时间时,球囊作为一种器械,创建间隙或举起椎体,因此允许沿着脊柱轴线的负载承载和/或共担。 When the balloon implanted in a very short period of time, the balloon as an instrument to create a gap or lift the vertebral body, thus allowing the load carrying along the axis of the spine and / or sharing. 另选地,当球囊留在患者体内较长一段时间时,球囊用作植入物。 Alternatively, when the balloon remain in the patient a longer period of time, the balloon is used as an implant. 球囊可留在腔内一段规定时间包括(例如)一个小时、一天、若干天、数周、数月、或数年、或甚至可永久留在骨内。 Balloon remain in the chamber for a specified period of time include (for example) one hour, one day, several days, weeks, months, or years, or even permanent stay in the bone.

[0027] 球囊内容物材料可为以下多种材料中的任意一种或组合:流体,例如,水、盐溶液、溶液、不透射线对比剂溶液;弹力型内容,例如,(尤其是基于硅胶的)弹性体、水凝胶、硅酮;刚性内容,例如,聚甲基丙烯酸甲酯(PMMA)、基于羟基磷灰石的材料、基于磷酸钙的材料,以及其他骨水泥;颗粒,例如,流体中的骨、聚合物、骨碎片;以及生物可吸收材料。 [0027] The contents of the balloon material may be a variety of the following materials or a combination of any one of: a fluid, e.g., water, salt solutions, solutions, radiopaque contrast solution line; elastic type content, e.g., (particularly those based on ) silicone elastomer, hydrogel, silicone; rigid content, e.g., polymethyl methacrylate (PMMA), a material based on hydroxyl apatite, calcium phosphate-based materials, cement and other bone; particles, e.g. , fluid bone, polymers, bone fragments; and bioresorbable material. 骨水泥可提供一种刚性构造或为弹性的;刚性和弹性都可通过诸如聚合作用或结晶反应等化学反应在合适部位实现。 Bone cement can be configured to provide a rigid or flexible; rigidity and elasticity can be crystallized such as by polymerization reaction or a chemical reaction in a suitable site implementation. 也可使用固化材料提供刚性构造,例如:聚合物、结晶固体、弹性体、以及玻璃。 Curable materials may also be used to provide a rigid structure, for example: a polymer, a crystalline solid, an elastomer, and glass. 水相流体(诸如盐溶液、对比剂、二者混合等)以及弹性体提供减震垫。 Aqueous phase liquid (such as saline, contrast agents, both mixed, etc.) and provide elastomer cushioning. 该装置提供的减震垫旨在恢复与球囊相邻的任何变弱/损伤的结构,以及保护与球囊相邻的任何完整/健康结构。 Any structure weakened / damage the device provides cushioning aimed at restoring the adjacent balloon and the balloon adjacent to the protection and complete any / health structure. 当前使用的将两个椎体融合在一起的装置的一个问题是最后融合的椎体在附近椎间盘中产生相同的问题,因为融合体通过使附近椎间盘超负载补偿椎间盘的缺失。 One problem the two vertebrae fused together devices currently in use is the final fused vertebrae same problem occurs in the vicinity of the intervertebral disc, because the disc fusion by near ultra Missing load compensation disc. 相反,球囊的实施例通过生成缓冲垫以及恢复相邻椎体提供减震效应。 In contrast, the embodiment of the balloon providing cushioning effect by generating and recovery cushion adjacent vertebral bodies.

[0028] 在一个另选实施例中,球囊的一些隔室可提供减震垫,并且其他隔室提供刚性构造。 [0028] In an alternative embodiment, some of the compartments of the balloon may provide cushioning, and the other compartment providing a rigid structure. 在该实施例中,减震隔室可填充比刚性隔室更多量的内容物。 In this embodiment, the damping compartment can be filled with a larger amount than the rigid compartment contents. 例如,如果腔经历了压力突然上升并且被压缩,填充量较大的减震隔室吸收压力上升的冲击,填充量较小的刚性隔室防止该腔的高度下降至刚性隔室的高度之下。 For example, if the chamber has experienced a sudden increase in pressure and compressed, filled with a large amount of damping compartment to absorb impact pressure rise, less populated rigid compartment to prevent the height of the chamber is lowered to the height of the rigid compartment under .

[0029]内容物材料也可为二种成分的混合物,例如具有固化剂的骨碎片。 [0029] The content material may also be a mixture of two kinds of components, such as bone fragments with a curing agent. 流体是可行的,但是不推荐,因为流体使密封装置和阀门均变得重要。 Fluid is possible, but not recommended, because the sealing means and the fluid valves are becoming important. 如果球囊将填充流体以及被植入较长一段时间,推荐厚壁球囊。 If fluid fills the balloon to be implanted and a longer period of time, the recommended thick-walled balloon. 根据一个实施例的密封或结合创建了防漏封闭,以防止球囊的内容物泄漏出来。 According to one embodiment of the seal or combination creates a leakproof closure to prevent leakage of the contents out of the balloon. 一个实施例包含将流体插入球囊内,其中膨胀球囊用作将椎体举起至需要高度的器械。 One embodiment includes a balloon is inserted into a fluid, wherein the inflatable balloon is used to lift the required height of the vertebral body of the instrument. 然后从球囊中移除流体(即,缩小球囊),并且从患者体内移除球囊(即,取回球囊)。 The balloon is then removed from the fluid (i.e., reduced balloon), and the balloon is removed from the patient (i.e., retrieve the balloon). 一旦恢复高度,假设所创间隙没有塌陷,骨水泥、保持架、或任何其他装置可以插入以占据球囊创建的间隙。 Once the recovery height, assuming that there is no gap created by the collapse of the bone cement, cage, or any other device can be inserted in order to occupy the space created by the balloon.

[0030] 在一些实施例中,内容物材料能在体温以上温度(约98.6 T )加热以便它更快硬化(约140 0F - 160 0F );施加热加速内容物材料的硬化。 [0030] In some embodiments, content material can be heated at a temperature above body temperature (about 98.6 T) so that it is faster curing (about 140 0F - 160 0F); applying heat to accelerate the hardening of the material contents. 加热内容物材料而不是整个球囊或甚至球囊壁。 Heating the material rather than the entire contents of the balloon, or even a balloon wall. 可以选择性加热的优选内容物材料的例子包括PMMA。 Selectively heating the contents of the preferred materials include PMMA. 可以选择性地将热施加于球囊不同体积的内容物材料。 Selectively applying heat to the contents of the different volumes of the balloon material. 可以将热探针附加至该装置加速化学反应以硬化球囊内容物。 Thermal probe can be attached to the device in order to speed up chemical reactions harden balloon contents. 可以在将多空间球囊插入患者体内之后施加热。 Heat can be applied after the multi-space balloon inserted into the patient. 优点是一旦球囊被填充,它能留在患者体内。 Advantage is that once the balloon is filled, it will stay in the patient. 内容物材料硬化,仅仅通过体温或通过施加额外的热以硬化球囊内的内容物;这消除材料从球囊泄漏的担心,因为材料为硬化的材料,尤其在球囊将留在体内较长一段时间的情况下。 The contents of the material is cured only by temperature or by applying additional heat to the contents harden inside the balloon; this eliminates the worry about material leaking from the balloon, because the material is hardened material, especially in the balloon will stay in the body longer period of time under the circumstances. 由于(如果长期植入)球囊自身潜在的机械退变或裂开,球囊内容必须生物相容。 Because (if long-term implant) balloon own potential mechanical degeneration or split, the balloon content must be biocompatible. 另选地,加热整个球囊,因为内容物硬化时热可能改变不了球囊壁。 Alternatively, heat the entire balloon, because the contents were not likely to change when the hardening heat the balloon wall.

[0031 ] 在准确压力和体积控制下提供内容物材料。 [0031] offers accurate material under pressure and volume control. 在一个优选实施例中,将球囊充胀以直接抵靠将恢复的骨。 In a preferred embodiment, the balloon is inflated to restore directly against the bone. 这将使安装的球囊迫使损伤骨进入减少骨折以及恢复损伤骨构造的结构。 This will force the installation of a balloon into the damaged bone fracture reduction and recovery of structural damage bone structure.

[0032] 根据一个实施例的方法包括基于患者椎间盘退变阶段或基于退变进度定制球囊内容物。 [0032] The method according to one embodiment comprises a balloon degeneration custom content based on the progress of the patient or on the stage disc degeneration. 在退变早期阶段,优选的内容物材料为盐溶液、水凝胶、弹性体(或弹性体水泥)、或硅胶类材料。 In the early stages of degeneration, the preferred material for the contents of the saline solution, a hydrogel, elastomer (or elastomer cement), or silicone-based material. 在退变早期阶段,该方法提供治疗节段稳定以及相邻节段保护。 In the early stages of degeneration, the method provides a stable therapeutic segments and adjacent segments protection. 在椎间盘退变中级阶段,优选内容物材料包括骨水泥;刚性混合材料,例如,基于羟基磷灰石的材料和基于磷酸钙的材料;以及颗粒材料。 In the intermediate stage disc degeneration, preferably contents materials include bone cement; mixed rigid material, for example, a material based on hydroxyapatite and calcium phosphate-based materials; and particulate material. 在退变中级阶段,该方法提供刚性构造以允许发生骨融合。 In the intermediate stage of degeneration, the method provides a rigid structure to allow bone fusion. 在椎间盘退变晚期阶段,优选内容物材料包括骨水泥和刚性混合材料,例如,基于羟基磷灰石的材料和基于磷酸钙的材料。 In the late stages of disc degeneration, preferably contents materials include bone cement mixing and rigid material, for example, a material based on hydroxyapatite and calcium phosphate-based material. 在退变晚期阶段,该方法提供了完全覆盖椎体终板的一种刚性填充,并且由于针对椎体终板的渗透性,允许填充物渗透终板进入椎体导致首次稳定和加强。 In the later stages of degeneration, the method provides a rigid filled completely covered endplate, and because for the endplate permeability, allowing the filler penetration into the vertebral body endplate cause the first stable and strengthened. 由于椎间盘从早期至中期至晚期退变阶段的退变进度,可能很难决定必要的内容物。 Since the disc from the early to mid to late degeneration degeneration progress stage, it may be difficult to determine the necessary contents. 该方法的一个目的是将球囊内容物与疾病或椎间盘退变的进度相匹配。 It is an object of this method is the balloon contents and the disc degeneration disease or progress to match. 可移除并且用与疾病进程一致的不同填充物替换球囊中的内容物材料。 Alternatively the balloon may be removed and the contents of the material is consistent with the disease process in different fillers.

[0033] 另外,球囊外表面可涂上涂层或纹理以帮助球囊与周围骨物质更加融合或促进患者接纳球囊。 [0033] In addition, the outer surface of the balloon can be coated or textured coating to help the balloon with the surrounding bone substance fusion or promote more patients receiving balloon. 选择球囊材料、涂层和纹理也可帮助防止身体对球囊的排斥。 Select balloon materials, coatings and textures can also help to prevent the body's rejection of the balloon. 同样地,球囊外表面可涂上涂层或纹理以帮助球囊变得更防穿刺和撕裂。 Similarly, the outer surface of the balloon can be coated or textured coating to help prevent puncture the balloon more and tear. 球囊内表面可同样地涂上纹理或涂层以提高球囊性能。 The inner surface of the balloon may be coated with the same texture or coating to improve the performance of the balloon. 例如,球囊内表面可涂上涂层或纹理以增加球囊壁和内部材料之间的粘性,或另选地,如果(例如)球囊壁材料和内容物原本物理或化学不相容,以防止球囊壁与内容物材料之间的接触。 For example, coating the inner surface of the balloon can be coated or textured to increase the viscosity and the inner balloon wall between materials, or alternatively, if (for example) the balloon wall material and the contents of the original physical or chemical incompatibility, to prevent contact with the contents of the balloon wall material.

[0034] 将球囊插入已经准备允许球囊放置在椎间盘间隙中或损伤骨附近的骨腔或椎间盘间隙。 [0034] The balloon has been prepared to allow the insertion of balloon placed in the intervertebral disc space or bone cavity or bone damage near the intervertebral disc space. 在一些实施例中,在安装球囊之前,可清除或将骨内和治疗区域中的松质骨组织和骨髓从该区域中压缩出来。 In some embodiments, prior to installation of the balloon, or to clear the bone and the treatment area of cancellous bone and marrow tissue compression from this area. 可通过转移或重新定位松质骨和骨髓至骨内非治疗区域,或通过使用铰刀或某其他装置从骨内移除材料,来完成治疗区域清理。 By transfer or reposition the bone and bone marrow to a non-treatment area, or removing material from the bone by using a reamer or some other means to complete the treatment area to clean. 在间隙在球囊插入前清理的实施例中,需要更少阻力以展开或膨胀或另外安装球囊。 Balloon inserted in the gap before cleaning embodiment, requiring less resistance to expand or inflate a balloon or another installation. 另选地,在椎间盘间隙,可以执行椎间盘切除术以移除椎间盘。 Alternatively, the disc space, you can perform a discectomy to remove the disc. 这些方法在融合促进装置在球囊之后插入的实施例中尤为有用。 In these methods, after fusion promoter apparatus particularly useful embodiment, the balloon is inserted. 在一些实施例中,球囊是插入以促进融合的装置。 In some embodiments, the balloon is inserted into the device in order to facilitate integration.

[0035] 另外,可冲洗或抽吸骨腔或椎间盘间隙以允许球囊植入并且以创建适合骨生长的环境。 [0035] In addition, flushing or aspiration of bone cavity or an intervertebral disc space to allow the balloon implant and bone to create a suitable environment for the growth. 优选地,抽吸将足够移除将恢复区域内的松质骨或椎间盘材料。 Preferably, the suction will be enough to restore the removed cancellous bone or disc material within the region. 更优选地,将通过这种方式抽吸超过满安装球囊范围约2mm至4mm的区域。 More preferably, the suction region over the full range of installation balloon from about 2mm to 4mm in this way. 可证明,清理腔的治疗区域附近或之内的基本所有骨髓对于恢复骨并且将球囊作为假体装置并入留在腔中尤为有用。 Provable, substantially all of the bone near the treatment area of the cleaning chamber or within the restoration of bone and the prosthetic device incorporated balloon remain in the chamber is particularly useful. 当球囊在腔内充胀时,预清理腔内材料提供了更低阻力。 When the balloon is inflated in the cavity, the cavity precleaning material provides lower resistance. 授予Weikel的名称为“Tools and methodsfor creating cavities in bone”的美国专利N0.6,679,886 (其内容以引用方式并入本文)描述了在骨中造腔方法。 U.S. Patent N0.6,679,886 (the contents of which are incorporated by reference herein) granted Weikel name is "Tools and methodsfor creating cavities in bone" describes the method of making the cavity in the bone. 在另一个实施例中,椎间盘或椎间盘间隙不需要在将球囊放置在椎间盘间隙中之前清理掉。 In another embodiment, the disc or disc space is not required before the balloon is placed in the intervertebral disc space cleared away. 在该实施例中,导丝,优选预弯导丝,将球囊引导至椎间盘间隙并且在损伤部位内膨胀球囊,压缩球囊周围的任何组织或骨。 In this embodiment, the guide wire, preferably pre-bent guide wire, balloon guide to the intervertebral disc space and expandable balloon within the lesion, the balloon to compress any tissue or bone around.

[0036] 本领域的一个挑战是椎间盘后路在手术期间具有有限的通道,尤其在外科医生使用工具全部是直形工具的情况下。 A challenge [0036] Those skilled in the posterior intervertebral disc during surgery has limited channels, in particular the use of tools in all surgeons at Straight Tool situation. 外科医生必须顺利绕过拐角并且在接近整个椎间盘和将任何装置放置在椎间盘的正确位置时经历一段困难时期。 The surgeon must be smoothly rounded the corner and nearly the entire disc in the correct location and any device is placed on the disc when going through a difficult period. 因此,该方法包含引入处于收缩状态具有缩小外形的球囊然后一旦球囊被输送至需要位置则将球囊充胀的步骤。 Thus, the method comprises introducing in a contracted state of reduced profile when the balloon is then conveyed to a desired position the balloon will be inflated balloon having a step. 这一问题的又一个解决方法通过插入处于收缩状态具有小直径设备的装置来实现;因此,外科医生能使用后路插入球囊并且避免前路的限制。 This problem has a solution in a contracted state apparatus by inserting a small diameter device has to achieve; therefore, the surgeon can use to insert a balloon and avoid posterior limit of the road.

[0037] 在一些实施例中,可通过将球囊(例如,简单的球形球囊)插入患者腔内预造一个腔。 [0037] In some embodiments, the balloon can be obtained by (e.g., a simple spherical balloon) inserted into a patient made a pre-chamber cavity. 在该实施例中,将球囊插入患者体内,膨胀球囊,从而创建上述腔,并且移除球囊。 In this embodiment, the balloon into the patient, inflate the balloon, thereby creating said cavity, and the balloon is removed. 然后根据该实施例的球囊被插入预造腔,并且能插入、展开、膨胀、和/或另外安装进入患者腔内。 Then inserted pre-made cavity balloon according to this embodiment, and can be inserted, expand, expand, and / or to install into a patient cavity. 球囊在预造腔中比它将在充满组织、软骨、骨等的腔中遇到的阻力更小。 In the pre-made balloon cavity filled than it encountered in tissue, cartilage, bone cavity less resistance.

[0038] 注意,球囊通路的铺使用通过3mm至1mm直径导管的后微创手术(MIS)方式,甚至使用仅仅Imm至4_的后经皮方式。 [0038] Note that the balloon passage shop through the use of 3mm to 1mm in diameter conduit after minimally invasive surgery (MIS) mode, even using only Imm to 4_ after percutaneous manner. 通过后路插入的装置的大小受神经根之间的间距限制。 The size of the device inserted through the posterior limit of the spacing between the affected nerve root. 因此,球囊从椎间隙或腔内膨胀以减少对神经根的潜在创伤并且仍允许椎间盘间隙高度的恢复。 Thus, the balloon from the disc space or cavity is expanded to reduce the potential trauma to the nerve root and still allow the disc space height recovery. 另选地,因为球囊是在收缩状态时被引入,外科医生能使用侧路、前侧路、或前路引入球囊,工具为最小直径,因此降低了干扰敏感性软组织(诸如神经)的风险。 Alternatively, since the balloon is in the retracted state is introduced, the surgeon can use the road side, the front side of the road, or anterior balloon is introduced, the minimum diameter of the tool, thus reducing the interference susceptibility of soft tissue (such as a nerve) of risk.

[0039] 在一些方法中,球囊能在患者体外被卷成管状形状;选择球囊形状,或在球囊被卷成管状形状之前,球囊被结合成其形状,连接至球囊导管的其他组件,并且通过在球囊表面附上盖套保持在那个卷曲状态。 [0039] In some methods, the patient's body in the balloon can be rolled into a tube shape; choose the shape of balloon, or balloon prior to being rolled into a tubular shape, are combined into a balloon shape, the balloon catheter is connected to the other components, and the surface of the balloon by attaching the cover sleeve held in the crimped state. 然后球囊通过工作套筒或其他管状导管被插入体内,一旦在患者体内或合适腔内就展开。 Then the balloon is inserted into the body through the work of other tubular sleeve or catheter, once in the patient or a suitable cavity to expand. 另选地,球囊能围绕患者体外的导丝卷起,一旦在患者体内或合适腔内就展开。 Alternatively, the balloon can rotate around the patient's body guide wire rolled up, once in a patient or a suitable cavity to expand. 这种方法允许球囊凭借小外形和管状形状被插入,然后展开成扁平形状,因为球囊还没有充胀。 This method allows the balloon with a small form factor and are inserted into a tubular shape, and then expand into a flat shape, because the balloon has not been inflated. 卷起的球囊能根据上述任何方法插入预造或清理的腔内,以在其展开或膨胀时遇见更小阻力。 Rolled balloon cavity according to any of the above methods to insert a pre-made or cleaned to time in its expanded or expanded to meet less resistance. 然后通过患者适当结构恢复所需的任何内容物将球囊或球囊的各个隔室充胀。 Then recover anything was needed by the patient to the appropriate structure of each compartment or balloon inflated balloon.

[0040] 图1是用于从单空间球囊形成多空间球囊的一种套件的透视图。 [0040] FIG. 1 is a perspective view of a kit from a single space balloon formed more space balloon. 在套件中提供了单空间球囊2以及至少一个环5。 It provides a single space balloon 2 and at least one ring 5 in the kit. 优选地,套件包括几何特征不同的多个环5。 Preferably, the kit includes a plurality of different geometric features ring 5. 图1A示出示例性环5在其右端具有角度7并且在其左端具有角度9。 Figure 1A illustrates an exemplary loop having a right angle at its 5 7 and 9 at an angle at its left end. 环5的角度7和角度9确定多空间球囊的各空间的取向和角度;各空间采用环5的成角。 Angle and angle ring 5 7 9 determine much space balloon orientation and angle of each space; each space using angled ring 5. 环5的角度7和角度9能设置成预定角度。 5 and 7 the angle of the angle ring 9 can be set to a predetermined angle. “预定的”是指预先确定的,因此在将环5插入单空间球囊2之前,预定角度必须是确定的,例如,选定的或至少已知的。 "Prescribed" means determined in advance, so before the second ring 5 is inserted into a single space balloon, must be determined by a predetermined angle, for example, selected or at least known. 如图1B、图1C、图1G、图11、和图1K所示,一种多空间球囊10具有带角度7和角度9的环5。 FIG. 1B,. 1C, 1G, 11, and as shown in Figure 1K, a balloon 10 having a multi-angled space and angle of the rings 9 7 5. 一旦环5被插入单空间球囊2,即创建多空间球囊10。 Once the ring 5 is inserted into the balloon 2 single space, that create more space balloon 10.

[0041] 在一个实施例中,一旦单空间球囊2膨胀并且多空间球囊10形成,则可调节环5。 [0041] In one embodiment, when two single balloon expansion space and more space balloon 10 is formed, the ring 5 can be adjusted. 在另一个实施例中,一旦安装并且多空间球囊10形成,则环5不移动。 In another embodiment, once installed and more space balloon 10 is formed, the ring 5 does not move. 在又一个实施例中,提供套件时环5预先安装在单空间球囊2上。 In yet another embodiment, the provision of kits ring 5 pre-installed on a single space balloon 2.

[0042] 如图1B和IC所示,多空间球囊10由两个空间,空间1A和空间1B组成。 [0042] As shown in FIG. 1B IC, multi-space balloon 10 by two space space space 1A and 1B composition. 空间1A和空间1B的内容量取决于环5沿着单空间球囊2的长度、角度7、以及角度9的位置。 1A and 1B space space depends on the amount of content along a single space balloon ring 5 2 lengths, angles 7, 9 and position angle. 外科医生能在手术前或期间决定多空间球囊10中所需的空间量。 The surgeon can determine the amount of space required more space balloon 10 prior to or during surgery. 可调节环5以改变多空间球囊10的空间1A和空间1B的角度和容量。 Adjustable ring 5 to change the space and more space balloon 10 1A and 1B, angles and space capacity. 根据该实施例,可在单空间球囊2上放置一个以上的环5以创建两个以上的空间。 According to this embodiment, in a single space to place a balloon over the ring 5 to create two more space on the 2. 如图1A所示,可选择环5和角度7和9的大小以满足特定患者和应用的需要。 1A, the size and angle of 5 selectable ring 7 and 9 to meet the needs of a particular patient and applications. 可基于环的数量改变形成多空间球囊10的空间的数量。 Number of rings can be based on the number of space-Space balloon 10 changes shape. 图1E是具有三个空间1AUOB^ 1C的多空间球囊10 ;图1I和IG是各自具有五个和六个空间的多空间球囊10。 Fig. 1E is a three spatial 1AUOB ^ 1C multi-space balloon 10; Fig. 1I and IG are five and six each have a space of more than 10 space balloon.

[0043] 图1B、图1C、图1E、图1G、和图1I是多空间球囊10的透视图。 [0043] FIG. 1B, FIG. 1C, 1E, Fig. 1G, and FIG. 1I is a perspective view of FIG. 10 multi-space balloon. 如图1B、图1C、图1E、图1G、和图1I所示,多空间球囊10具有闭合端15和密封端17。 FIG. 1B,. 1C, 1E, FIG. 1G, and 1I, the multi-space having a closed end 15 of balloon 10 and sealed end 17. 闭合端15在外科医生和/或插入器械远侧,防止内容物从多空间球囊10中释放。 Closed end 15 surgeons and / or distal insertion device to prevent the contents of multiple spatial released from the balloon 10 in. 密封端17在外科医生和/或插入器械近侧。 Sealed end 17 surgeons and / or proximal insertion instrument. 将单空间球囊2充胀,通过将充胀端18和诸如注射器(例如,高压注射器,其具有在多空间球囊10被充胀时进行体积读取的压力计)等插入装置连接,并创建多空间球囊10。 The single-space balloon 2 inflated by inflation and end 18 such as a syringe (for example, high-pressure injector, which has more space when the balloon 10 is inflated volume were read pressure gauge) and other insertion device connections, and Create more space balloon 10. 用于通过充胀端18将多空间球囊10充胀的内容物取决于患者的具体需要,并且如上所述可包括非刚性或刚性内容物。 Terminal 18 for inflation through the balloon 10 is inflated more space is required depends on the specific contents of the patient, as described above, and may include a non-rigid or rigid content. 诸如多空间球囊10等临时植入物在多空间球囊10充胀后填充盐溶液、水溶液、或其他非刚性内容物。 Such as multi-space balloon 10 other temporary implants after more than 10 space balloon is inflated filling salt solution, aqueous solutions, or other non-rigid contents. 然后将球囊充胀端18与插入器械和密封端17断开,密封端17通过使用阀密封多空间球囊10的近端而创建,例如,以防止内容物从多空间球囊10内释放。 The balloon is then inflated end 18 and sealed end of the insertion instrument 17 is disconnected, the sealed end 17 by use of the valve seal the proximal end of the balloon 10 is more space created, for example, to prevent the contents from the release of more space inside the balloon 10 . 诸如多空间球囊10等永久植入物填充硬化的骨水泥,例如PMMA或其他刚性内容物。 Such as multi-space balloon 10 and other permanent implant filled with hardened cement, such as PMMA or other rigid contents. 然后将球囊10的充胀端18与插入器械和密封端17断开,密封端17通过将多空间球囊10近端与插入器械切断或断开而创建。 The balloon is then inflated end 18 of the insertion device 10 and the end seal 17 is disconnected, the sealed end 17 by the multi-space balloon 10 and the proximal end of the insertion instrument off or disconnect and create.

[0044] 图1D、图1F、和图1H是具有不同数量的环5以在球囊充胀后创建不同数量的多空间球囊10的空间的单空间球囊2的透视图。 [0044] FIG. 1D, Fig. 1F, and 1H is a ring 5 with a different number of different amounts of space to create more space balloon 10 after the balloon inflated balloon perspective view of a single space. 2. 插入器械连接至充胀端18近侧。 The insertion device 18 is connected to the proximal end of the inflatable. 在将内容物插入单空间球囊2中以防止内容释放之前,远侧闭合端15是闭合的。 Before you insert the contents of a single space balloon 2 to prevent the contents of the release, closed distal end 15 is closed. 将内容物插入单空间球囊2中以创建多空间球囊10。 The contents were inserted into a single space balloon 2 to create more space balloon 10. 环5的角度7和角度9为多空间球囊10提供不同形状。 Multi-space balloon 10 to provide different shapes and angles of the ring 5 7 9 angle.

[0045] 充胀图1D所示的单空间球囊2导致多空间球囊10具有肾脏或香蕉形状,如图1E所示。 [0045] FIG. 1D inflatable balloon shown in a single space 2 lead balloon 10 having multiple spatial kidney or banana shape, as shown in Fig 1E. 在另一个实施例中,充胀图1F所示的单空间球囊2导致多空间球囊10具有蛇状形式,如图1G所示。 In another embodiment, the inflatable balloon shown in FIG. 1F single space in lead-Space 2 has a serpentine form balloon 10, as shown in FIG 1G. 在又一个实施例中,图1H所示单空间球囊2由限制单空间球囊2的盖套19所覆盖。 In yet another embodiment, Fig. 1H single space balloon covered in Figure 2 by a single space restrictions balloon cover 2 sets of 19. 由于内容物通过充胀端18插入单空间球囊2 (图1H所示),盖套19起初限制单空间球囊2的膨胀。 Since the end of the contents through the inflatable balloon 18 is inserted into a single space 2 (as shown in Fig. 1H), the cover sleeve 19 initially limit 2 single space balloon is inflated. 单空间球囊2的闭合端15随着在远端退出盖套19而打开。 Single-space balloon along with the closed end 2 of 15 at the distal end cover 19 and withdraw the cover open. 随着单空间球囊2退出盖套19,它不再受盖套19的限制,如图1I所示多空间球囊10形成,具有扭曲构造。 With the single exit cover 2 sets of space balloon 19, it is no longer limited by the cap sleeve 19, as shown in Figure 1I more space balloon 10 is formed, it has a twisted structure.

[0046] 在一些实施例中,环5由诸如不锈钢或钛等能作为标记物的金属制成。 [0046] In some embodiments, the ring 5 such as stainless steel or titanium metal, etc. can be used as markers. 在另一个实施例中,环5由诸如钴铬合金等作为X射线标记物的材料制成。 In another embodiment, the ring 5 is made of cobalt-chromium alloy, such as materials made of X-ray marker. 在另一个实施例中,环5由聚合物制成,使该环与磁共振成象(MRI)技术更加相容。 In another embodiment, the ring 5 is made of a polymer, so that the ring with the magnetic resonance imaging (MRI) technology is more compatible. 也可用PEEK制作环5。 It can also be produced PEEK ring 5. PEEK为半晶状热塑性的,具有很好的保持至高温的机械和抗化学腐蚀性能。 PEEK semi-crystalline thermoplastic, has good holding to high mechanical and chemical resistance. 因此,PEEK被视为用于许多医用植入物应用的先进生物材料。 Thus, PEEK is considered used in many medical implant applications of advanced biomaterials.

[0047] 环5可包括单向阀,即允许流体仅仅朝一个方向而不是相反方向流动的阀。 [0047] ring 5 may comprise a one-way valve that allows fluid only in one direction and not in the opposite direction of the flow valve. 也可将简单的膜用作单向阀。 The film can also be used as a simple one-way valve. 可在技术人员技能范围内选择具体的单向阀,以满足特定患者和应用的需要。 You can select a specific one-way valve within the skill range of skills to meet the needs of a particular patient and applications.

[0048] 为了进一步缩小球囊直径,球囊能通过焊接、胶粘、缝合、或任何其他本领域已知结合方法附接到环5。 [0048] In order to further reduce the diameter of the balloon, the balloon by welding, gluing, stitching, or any other combination of methods known in the art is attached to the ring 5. 如图1J所示,环5在结合部位12和结合部位14被结合到多空间球囊10。 FIG. 1J, the ring 5 binding sites 12 and 14 are bonded to the binding site more space balloon 10. 在另选实施例中,如图1K所示,单空间球囊2和单空间球囊3在结合部位12和结合部位14被结合到环5。 In an alternative embodiment, as shown in FIG. 1K, single-space balloon 2 and 3 in a single space balloon binding sites 12 and 14 binding sites are incorporated into the ring 5.

[0049] 图2A是根据另一个实施例的一种单或多空间球囊的俯视图,图2B是其侧视图。 [0049] Figure 2A is a space balloon in accordance with one or more single plan view of another embodiment, FIG. 2B is a side view thereof. 图2A示出相互堆叠的二层未切割薄片20。 2A shows a two-story stacked on each other uncut sheet 20. 在图2A中,二层未切割薄片20为矩形,但是未切割薄片20的形状可为任何形状,例如,圆形、三角形、正方形、或椭圆形。 In Figure 2A, the second floor uncut sheet 20 is rectangular, but the shape of the uncut sheet 20 may be of any shape, e.g., circular, triangular, square, or oval. 二层未切割薄片20刻有标记24。 Layer uncut sheet 20 engraved marker 24. 标记24的交叉点能创建遍布未切割薄片20的各个空间26、28、30。 Intersection mark 24 can create various spaces around the uncut sheet 20. 26,28,30. 通过将二层未切割薄片20结合在一起,球囊22从未切割薄片20中被创建。 By Layer uncut sheet 20 together, the balloon 22 never cut sheet 20 is created. 能通过本领域已知方法将这些层结合在一起,例如,焊接、加热、胶粘、缝合、摩擦、激光束技术、具有附加吸收介质的激光束技术、以及能量束方法。 By methods known in the art these layers together, e.g., welding, heating, gluing, stitching, friction, laser beam technology, laser beam technology with additional absorption medium, and an energy beam method. 球囊22可从未切割薄片20中以需要填充患者腔中的任何形状裁剪出来。 Balloon 22 may never need to cut the sheet 20 to fill the cavity of a patient any shape cut out. 如上文所讨论的,球囊22的边缘结合在一起。 As discussed above, the edges of the balloon 22 together. 在一些实施例中,球囊22在类似台式打印机的装置中生产。 In some embodiments, the balloon 22 production apparatus similar desktop printer. 未切割薄片20可由聚合物或金属制成。 Uncut sheet 20 may be made of a metal or a polymer. 在一些实施例中,未切割薄片20可由网状材料制成,这些材料可由允许渗透的聚合物或金属制成。 In some embodiments, the uncut sheet 20 may be made of mesh material, which may allow the penetration of the polymer material or metal. 金属可由金属薄膜构成,优选地,由诸如镍钛诺等形状记忆合金制成。 Metal may be a thin metal film, preferably by such as nitinol shape memory alloy. 在另一个实施例中,未切割薄片20可为包含印刷的黑色标记的电路板,其中标记在暴露在发热光下时结合在一起;光仅被标记(或黑线)吸收,局部发热并且因此在那个部位结合,否则光被传输穿过基本上透明的薄片。 In another embodiment, an uncut sheet 20 may comprise a black mark printed circuit board, wherein the marker is exposed to light when combined with heat; light only are marked (or black line) absorption, and thus local heat in the binding site, or the light is transmitted through the substantially transparent sheet.

[0050] 该实施例可定制以填充患者的腔。 [0050] This embodiment can be customized to fill the cavity of the patient. 能可选地填充或不填充标记24创建的未切割薄片20或球囊22的隔室,这取决于患者的具体需要。 May optionally padding has been marked uncut sheet 24 or 20 of the balloon 22 to create the compartment, depending on the particular needs of the patient. 这为填充哪个隔室、不填充哪个隔室、为隔室中的每个提供什么内容物提供不同分布和无限可能。 This is what filled compartment, which compartment is not filled, and provide different possibilities for the distribution of each compartment to provide any contents.

[0051] 隔室可填充不同材料,具体取决于患者需要。 [0051] compartments can be filled with different materials, depending on patient needs. 例如,一些隔室(例如,隔室26和30)可填充水、盐溶液、对比剂溶液、或相似类型的物质,以提供缓冲或减震效应(“缓冲隔室”)。 For example, some of the compartments (e.g., the compartments 26 and 30) can be filled with water, salt solutions, contrast solution, or a similar type of material to provide a cushioning or shock-absorbing effect ( "buffer compartment"). 其他隔室(例如,隔室28)可填充诸如聚合物或骨水泥等硬性材料以提供支撑和高度并且作为制动器(“支撑隔室”)。 Other compartments (for example, compartment 28) can be filled with a polymer or other hard material such as bone cement to provide support and as a brake and height ( "supporting compartment"). 在该实施例中,缓冲隔室可比支撑隔室包含更多材料,以便如果腔经历突然压力,缓冲隔室提供抑制冲击的柔性,支撑隔室则作为制动器防止球囊22的高度缩减至支撑隔室的高度之下。 In this embodiment, the cushioning compartment than the support material contains more compartments, so that if the pressure chamber is a sudden, the buffer compartment provided for suppressing the rush of a flexible, supporting compartment as a stopper to prevent the height of the balloon 22 to the reduced-supporting the height of the chamber below. 一旦球囊22插入患者的腔内,即能填充隔室。 Once the balloon 22 is inserted into the cavity of the patient, which can fill the compartment.

[0052] 在另一个实施例中,距离球囊22的边缘最近的隔室能为支撑隔室,如上文所讨论的,在球囊内部的隔室能为缓冲隔室。 [0052] In another embodiment, the balloon 22 from the edge of the nearest compartment able to support the compartment, as discussed above, the balloon inside the compartment can buffer compartment. 在该实施例中,支撑隔室(如上文所讨论的)提供支撑和高度,但也作为填充缓冲隔室的制动器或界限。 In this embodiment, the supporting compartment provided (as discussed above) support and height, but also as a brake or limit fill the buffer compartment. 支撑隔室不限于球囊22的边缘,而能作为填充缓冲隔室的界限以任何模式布置在球囊上。 Supporting compartment is not limited to the edges of the balloon 22, and can define the limits of the buffer filling compartments arranged in any pattern on the balloon.

[0053] 在一些实施例中,隔室内容物可随着时间改变。 [0053] In some embodiments, the contents of the compartments may change over time. 以前为空的隔室能在以后被填充,或过去为缓冲隔室的隔室能移除其内容物,填充硬性材料,转化为支撑隔室。 Previously empty compartment can be filled in later, or the last compartment the buffer compartment can remove its contents, rigid filler material into the supporting compartment.

[0054] 图2B为另选实施例的侧视图。 [0054] FIG. 2B is a side view of an alternative embodiment. 在图2B中,未切割薄片20的标记24过去没有创建各个隔室,而是在球囊22被结合后,创建单空间球囊40。 In Fig. 2B, an uncut sheet 24 in the past did not create a mark each compartment 20, but after the balloon 22 are combined to create a single space balloon 40. 结合42为未切割薄片20被沿着球囊22轮廓的形状结合的部位。 42 is combined with uncut sheet is bonded along the shape of the balloon 22 profile portion 20.

[0055] 可在生产或插入患者体内之前或手术期间结合这些层未切割薄片20,允许手术期间定制植入物的形状和大小。 [0055] can be produced prior to or inserted into the patient during surgery or a combination of these layers uncut sheet 20 to allow the implant during surgery to customize the shape and size of the object. 在该实施例中,患者可进行术前评估以决定需要填充腔的球囊22的大小。 In this embodiment, the patient may be required to determine the preoperative evaluation of the size of the balloon-filled chamber 22. 在一些实施例中,未切割薄片20或球囊22可围绕导丝或插入器械卷曲并且引导至患者的腔。 In some embodiments, an uncut sheet 20 or 22 is rotatable about a balloon or a guide wire to guide the insertion device and crimped to the patient cavity. 在该实施例中,球囊22在插入前没有充胀。 In this embodiment, the balloon 22 before inserting not inflated. 这允许球囊以小外形插入。 This allows the balloon to insert a small form factor. 然后在腔内未切割薄片20或球囊22展开;球囊22则可由未切割薄片20结合而成。 Then in the cavity 20 or uncut sheet 22 to expand the balloon; balloon 22 may be 20 by the combination of uncut sheets. 然后外科医生决定将填充的各个隔室,或另选地,可膨胀整个球囊40,以提供可选的提升能力和恢复高度,具体取决于患者的需要。 The surgeon then decided to fill each compartment, or alternatively, the entire inflatable balloon 40 to provide an optional lifting capacity and a high degree of recovery, depending on the needs of patients.

[0056]患者的解剖情况以及填充未切割薄片20的隔室的不同可能性提供单独为每个患者创建的一组三维形状的球囊。 [0056] patient's anatomy and the different possibilities uncut sheet filled compartment 20 is provided separately for the three-dimensional shape of a balloon created for each patient.

[0057] 图3是根据另一个实施例的单或多空间球囊的透视图。 [0057] FIG. 3 is a perspective based on single or multi-space balloon to another embodiment of FIG. 多结合球囊50通过将三或更多张薄片56A、56B、56C沿着结合部位52结合在一起而创建。 More and balloon 50 by three or more sheets of sheet 56A, 56B, 56C along the binding site 52 together and create. 在一些实施例中,多结合球囊50在类似台式打印机的装置中生产。 In some embodiments, the multi-production and balloon 50 in an apparatus similar to a desktop printer. 可通过本领域已知方法将这些层结合在一起,例如,加热、胶粘、缝合、摩擦、压力、激光束技术、具有附加吸收介质的激光束技术、超声波技术、以及能量束方法。 By methods known in the art these layers together, e.g., heating, gluing, stitching, friction, pressure, laser beam technology, an additional absorbing medium having a laser beam technique, ultrasonic technique, and an energy beam method. 多结合球囊50提供一组三维随形球囊,不限于单空间的椭圆或球形或单结合球囊的形状。 More and balloon 50 provided with a set of three-dimensional shaped balloon is not limited to a single space or spherical or elliptical shape single binding balloon. 多结合球囊50的薄片56A、56B、56C可具有创建各个隔室的标记54,如结合上面的图2A和图2B所述。 Multi combination of balloon sheet 56A 50, 56B, 56C may have to create each compartment marked 54, as above in connection with FIG. 2A and FIG 2B. 可选择性地填充隔室以创建如上所述的唯一的解剖形状和一致性。 Selectively filling the compartments as described above to create unique anatomical shape and consistency. 可填充或不填充每个隔室;填充的隔室可填充为患者提供缓冲或支撑效应的材料。 You can fill or fill each compartment; filling compartment can be filled with cushioning material provided to patients or support effects. 在一些实施例中,隔室能以类似迷宫的式样填充,例如,位于与球囊平面平行的第二平面。 In some embodiments, the compartments can be filled maze-like pattern, e.g., in a second plane parallel to the plane of the balloon.

[0058] 图4A、图4B、图5A、和图5B是根据另外实施例的一种多空间球囊的透视图。 [0058] Figures 4A, 4B, the Figures 5A, and 5B is a perspective view of a multi-spatial Another embodiment of the balloon. 这些附图示出具有提升空间82和填充空间84的多空间球囊80。 These figures have shown improvement and filling the space 82 84 80 Multi-space balloon. 在一些实施例中,提升空间82和填充空间84的位置可以颠倒。 In some embodiments, the headroom and 82 to fill the space 84 can be reversed. 多空间球囊80可包括一个以上的提升空间82和一个以上的填充空间84以获得所需高度和稳定性。 Balloon 80 may include more space than a space 82 and a lifting of filled space 84 above to obtain the desired height and stability. 根据该实施例,提升空间82填充诸如盐溶液等易于移除的物质。 According to this embodiment, the material 82 to enhance the filling space such as ease of removal of the brines. 填充提升空间82以创建高度(例如,重建椎间盘间隙的高度)或提升骨腔中的任何断裂。 82 filled room for improvement to create height (for example, the reconstruction of the intervertebral disc space height) or promotion of any broken bone cavity. 一旦实现所需高度,移除提升空间82内的内容物。 Once achieved the desired height, remove the contents of room for improvement within 82. 然后将内容物注入填充空间84以维持提升空间82所创建的空间。 The contents were then injected into the filling space 84 to maintain the space 82 created room for improvement. 插入填充空间84的优选内容包括那些将使填充空间84变得刚性的内容物,诸如,聚合物或骨水泥。 Insert content filling space 84 preferably include those that will fill the space 84 becomes rigid contents, such as a polymer or cement.

[0059] 不同的提升空间82和填充空间84组合提供明显优势。 [0059] 82 different offers significant advantages to enhance the space and fills the space 84 combinations. 一个优势是更好的负载分布。 One advantage is a better load distribution. 另一个优势是当提升和重建椎间盘间隙时更好的控制。 Another advantage is better when the lifting control and reconstruction of the intervertebral disc space. 总之,两个具有不同功能的不同体积的组合比使用一个空间实现二种功能(这原本就需要权衡取舍)更好。 In short, the combination of two different volumes having different functions than using two kinds of functions to achieve a space (which inherently require tradeoffs) better.

[0060] 图4B示出由结合部位88隔开的提升空间82和填充空间84,结合部位由结合在一起的二张薄片创建。 [0060] FIG. 4B shows the binding sites 88 and 82 are separated room for improvement filling space 84, binding site created by the combination of the two sheets. 可通过本领域已知方法将这些薄片层结合在一起,例如,加热、胶粘、摩擦、激光束技术、具有附加吸收介质的激光束技术、超声波技术、以及能量束方法。 These methods known in the art sheet layer is bonded together, for example, heating, gluing, friction, laser beam technology, with additional absorption medium laser beam technology, ultrasound technology, and energy beam method. 图4B中的多空间球囊80由薄片材料形成。 Figure 4B multiple spatial balloon 80 is formed of sheet material. 薄片材料为外科医生提供随形球囊。 The sheet material is provided with a balloon shaped as a surgeon. 在其他实施例中,多空间球囊80由网状材料形成。 In other embodiments, the balloon 80 is formed by a multi-space mesh material.

[0061] 图5A示出包含由穿孔90隔开的提升空间82和填充空间84的多空间球囊80。 [0061] Figure 5A shows contain perforations 90 separated by a space 82 and lifting filling space 84 of the balloon 80 and more space. 穿孔90提供了控制裂口,其用于在预定断裂点隔开提升空间82和填充空间84。 Perforation 90 provides a control gap, which is used at a predetermined breaking point 82 spaced room for improvement and filling space 84.

[0062] 图5B也包含穿孔90以容纳提升空间82和填充空间84之间的控制裂口。 [0062] FIG. 5B also includes perforations 90 to accommodate the lift control gap 84 between the space 82 and fill the space. 如图5B所示的多空间球囊80还包含附接到多空间球囊80的导丝92。 Multi-space shown in Figure 5B further includes a balloon 80 attached to the guidewire 80 much space 92 of the balloon. 导丝92提供对将多空间球囊80插入和放置在骨腔中的控制。 Guidewire 92 provides more space for the balloon 80 is inserted and placed in the bone cavity control. 可通过撕开穿孔90移除导丝92。 It can be removed by tearing the perforation 90 guidewire 92. 在一些实施例中,导丝92可包括传感器或光源。 In some embodiments, guidewire 92 may include a sensor or a light source.

[0063] 在另选实施例中,填充空间84和提升空间82的位置可以颠倒。 [0063] In an alternative embodiment, the filling space 84 and space 82 to enhance the position may be reversed. 图5A和图5B所示多空间球囊80的任何内腔可为提升空间或填充空间。 5A and 5B shown more space balloon lumen 80 may be any room for improvement or fill the space. 哪种空间是填充空间84和提升空间82可能不是预定的。 What kind of space is filling space 84 and 82 may not be room for improvement predetermined. 多空间球囊80的所有空间可填充上文所讨论的任何内容物。 All space-Space balloon 80 may be filled any content discussed above.

[0064] 提升空间82为骨融合在腔中创建其他间隙并且能被移除,但是不一定非从多空间球囊80中移除。 [0064] 82 for the improvement of bone fusion to create additional space in the chamber and can be removed, but not necessarily more than 80 removed from the space balloon. 在另选实施例中,提升空间82可填充以创建间隙。 In an alternative embodiment, the room for improvement to create a gap 82 may be filled. 随后,填充空间84可填充上文所讨论的任何内容物,提升空间82可为空。 Then, fill the space 84 may be filled with the contents of any of the above discussion, the room for improvement 82 may be empty. 在以后的任何时间点,提升空间82可填充不同内容以为患者提供支撑或缓冲,或通过撕开穿孔90移除,具体取决于患者需要。 At any later point in time, to enhance the space 82 may be filled with different content that provide patients with support or cushioning, or by tearing perforation 90 is removed, depending on patient needs.

[0065] 尽管本发明参考某些优选实施例来描述,应当了解,本发明范围不限于这些实施例。 [0065] Although the present invention with reference to certain preferred embodiments thereof, it should be understood that the scope of the present invention is not limited to these embodiments. 球囊能被改装或扩大以适应球囊构成材料或制作工艺的详细制作方法。 The balloon can be modified or expanded to accommodate the detailed method of making balloon constituent material or production process. 相似地,多空间球囊的单空间的数量和间隙可改变以更好地适应腔。 Similarly, the number of multi-space and space balloon single space can be changed to better suit the cavity. 不同的球囊材料和表面涂层或不同材料的外层或表面涂层也可应用于球囊以促进安装时球囊外形更小。 Different balloon materials and surface coatings, or outer layer or surface coating may be applied to different materials of the balloon to facilitate a smaller balloon shape during installation. 以上实施例也能修改以便一个实施例的一些特征结构与另一个实施例的特征结构一起使用。 The above embodiment can be modified to a characteristic structure of some of the features of the structure of an example of another embodiment for use with the embodiment. 然而,本领域技术人员可以发现,这些优选实施例的变型符合本发明的精神,其范围由下文所阐述的权利要求所限定。 However, those skilled in the art may find variations of those preferred embodiments consistent with the spirit of the present invention, the scope of the rights set forth by the following requirements are defined. 也应明确指出的是,使用以上公开的各种球囊的方法步骤不局限于任何特定顺序。 It should also be clearly noted that the various steps of the method of using the balloon disclosed above is not limited to any particular order.

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