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Publication numberCN1533260 A
Publication typeApplication
Application numberCN 02814372
PCT numberPCT/US2002/022382
Publication date29 Sep 2004
Filing date11 Jul 2002
Priority date26 Oct 1998
Also published asCA2452508A1, CA2452508C, CN100515358C, DE60206274D1, DE60206274T2, EP1406548A1, EP1406548B1, US7052498, US7601152, US7670339, US20030130660, US20060064094, US20060084998, WO2003007830A1
Publication number02814372.8, CN 02814372, CN 1533260 A, CN 1533260A, CN-A-1533260, CN02814372, CN02814372.8, CN1533260 A, CN1533260A, PCT/2002/22382, PCT/US/2/022382, PCT/US/2/22382, PCT/US/2002/022382, PCT/US/2002/22382, PCT/US2/022382, PCT/US2/22382, PCT/US2002/022382, PCT/US2002/22382, PCT/US2002022382, PCT/US200222382, PCT/US2022382, PCT/US222382
Inventors马克M利维, 马克・M・利维, 伊兰格林伯格, 格林伯格
Applicant扩展整形外科公司
Export CitationBiBTeX, EndNote, RefMan
External Links: SIPO, Espacenet
Expandable orthopedic device
CN 1533260 A
Abstract  translated from Chinese
一种用于稳定骨骼的装置,包括一管状体(502),具有第一末端区(504)和第二末端区(506),两个末端区之间限定一纵轴;多个定位片(510),从第一末端区(504)伸展出,定位片包括有与第一末端区相连接的第一末端(510a),和与第一末端区相远离设置的第二末端(510c),第二末端能被控制地从通常的轴向折叠状态转变为完全横向膨胀状态;多个支撑臂(520),与定位片相连接,并且有一致动器(512)连接在支撑臂上,致动器(512)可相对细长体(502)轴向移动,从而使支撑臂控制定位片的第二末端(506)从折叠状态转变为膨胀状态。 An apparatus for stabilizing bone, comprising a tubular body (502) having a first end region (504) and a second end region (506) defining a longitudinal axis between two end regions; a plurality of positioning pieces ( 510), from the first end region (504) extending out of the positioning plate includes a first end (510a), and a second terminal region is connected to the first end region of the phase away from the set of the second end (510c), The second end can be controlled to change from the normal state is completely folded transversely axially expanded state; a plurality of support arms (520), and the positioning piece is connected, and has an actuator (512) connected to the support arm, caused by The second end of the actuator (512) movable relative elongate body (502) axial movement, so that the support arm to control the positioning plate (506) transition from a collapsed state to an expanded state. 可选地,此装置包括另一组定位片,从管状体的第二末端区(506)延伸出,或者是位于管状体的中间区域(530)。 Alternatively, the device includes another set of positioning piece extending from the second end region of the tubular body (506) out of, or is located in the middle region of the tubular body (530).
Claims(28)  translated from Chinese
1.一种用于稳定骨骼的装置,包括:一细长体,具有第一和第二末端区,所述两个末端区之间限定一纵轴;多个定位片,从所述第一末端区延伸出,所述定位片包括有与所述第一末端区相连接的第一末端,和远离所述第一末端区布置的第二末端,所述定位片的第二末端可被控制地从一通常的轴向折叠状态转变到一完全横向膨胀状态;多个支撑臂,与所述定位片相连接;以及一致动器,与所述支撑臂相连接,所述制动器可相对所述细长体轴向移动,从而使所述支撑臂控制所述定位片的第二末端从所述折叠状态转变到所述膨胀状态。 A device for stabilizing bone, comprising: an elongated body having a first end and a second zone defining a longitudinal axis between the two end regions; a plurality of positioning pieces, from the first terminal region extends, said positioning sheet comprises a first end, and said first end region remote from the first end region is connected to a second end of the arrangement, the second end of the positioning plate can be controlled converted from a generally axial collapsed state to a completely laterally expanded state; a plurality of support arms, and connected to said positioning sheet; and an actuator connected to said support arm, said brake with respect to said axial movement of the elongate member, thereby controlling the positioning of said support arm second end piece of the transition from the collapsed state to the expanded state.
2.根据权利要求1所述的装置,其中所述细长体包括一管轴,并且其中所述致动器包括一与所述支撑臂相连的轴环,所述轴环可以相对所述管轴轴向移动,从而控制所述定位片的第二末端相对所述纵轴完全横向向外以限定所述膨胀状态。 2. The apparatus according to claim 1, wherein the elongate body comprises a tubular shaft, and wherein said actuator comprises a collar coupled to said support arm, said collar relative to said tube may be axial movement of the shaft, thereby controlling the second end of the positioning plate relative to the longitudinal axis laterally outwardly to define the fully expanded state.
3.根据权利要求2所述的装置,其中所述致动器还包括一与所述轴环和细长体相连的细长构件,所述细长构件相对于所述轴环和细长体运动,以轴向控制所述轴环,从而控制中间区完全向外横向膨胀。 3. The apparatus according to claim 2, wherein said actuator further comprises an elongate member and the collar and the elongate body coupled to the elongate member relative to the collar and the elongate body campaign to control the axial collar, thereby controlling the intermediate area is completely outward lateral expansion.
4.根据权利要求3所述的装置,其中所述支撑臂在所述折叠状态下是基本上直的,并且包括有与所述轴环相连的第一末端及与相应定位片相连的第二末端,并且其中所述细长构件与所述轴环相连,从而,所述细长构件的轴向移动能引起所述轴环轴向移动,从而控制所述定位片的第一末端和支撑臂彼此朝向对方,并且使所述定位片和支撑臂完全横向向外弯曲。 The second device according to claim 3, wherein said support arm in the folded state are substantially straight and includes a first end connected to said collar and connected to the respective positioning piece end, and wherein said elongated member is connected to said collar, whereby axial movement of said elongated member to cause axial movement of the collar, so as to control the positioning of the first end piece and the support arm toward each other, and so that the orientation film and the supporting arm completely laterally outwardly bent.
5.根据权利要求3所述的装置,其中所述细长构件包括一管状构件,所述管状构件至少部分地延伸穿过所述管轴。 5. The apparatus according to claim 3, wherein the elongate member comprises a tubular member, said tubular member extending at least partially through the tube axis.
6.根据权利要求3所述的装置,还包括有一近端延伸部分,向近端延伸至超出所述定位片,所述近端延伸部分包括一个或多个孔眼,用来容纳横向穿过其中的固定装置。 6. The apparatus according to claim 3, further comprising a proximal end portion, extending proximally beyond said positioning sheet to the proximal extension comprising one or more apertures for receiving therethrough transversely fixtures.
7.根据权利要求1所述的装置,其中所述支撑臂连接到所述定位片的一中间部。 7. The apparatus according to claim 1, wherein said support arm is connected to an intermediate portion of the positioning sheet.
8.根据权利要求1所述的装置,还包括多个从所述第二末端区延伸出来的定位片,所述定位片在通常的轴向折叠构形与充分横向膨胀构形之间具有可膨胀性。 8. The apparatus according to claim 1, further comprising a plurality of extending out from the second end region of the positioning sheet, the sheet positioned between generally axial collapsed configuration and the fully expanded configuration having a transverse expansion.
9.根据权利要求8所述的装置,其中在所述第二末端区上的定位片通过支撑臂与所述致动器相连接。 9. The apparatus according to claim 8, wherein in said second end region of the sheet by positioning the support arm and the actuator is connected.
10.根据权利要求9所述的装置,其中所述细长体包括一含有管腔的管轴,其中所述致动器包括有一可旋转地容纳于所述管轴管腔中的细长构件,而且近端和远端处的轴环通过螺纹配合连接到所述细长构件,所述近端和远端轴环分别连接到所述管轴近端端部区和远端端部区上的支撑臂上。 10. The apparatus according to claim 9, wherein the elongate body comprises a tubular shaft comprising a lumen, wherein the actuator includes a rotatably received in the lumen of the tube axis of the elongate member , and the collar at the proximal end and a distal end connected to said elongated member by a threaded fit, the proximal and distal ends respectively connected to the collar of the tube axis and the proximal end region on the distal end regions The support arm.
11.根据权利要求10所述的装置,其中所述细长构件包括有螺纹旋向相反的近端和远端螺纹部,为了和所述细长构件的近端与远端螺纹区旋转配合,所述近端和远端轴环也分别包括螺纹区。 11. The apparatus according to claim 10, wherein the elongate member comprises a threaded proximal end and a distal end opposite the threaded portion, and the proximal and distal to the threaded area of the elongate member with the rotation, The proximal and distal collars were also comprises a threaded area.
12.根据权利要求1所述的装置,其中所述细长体包括一管轴,所述管轴包括一管腔,并且所述管腔内包括一第一螺纹部,其中所述致动器包括一细长构件,所述细长构件位于所述管腔中,并包括一第二螺纹部,用来与所述第一螺纹部滑动配合,通过旋转所述细长构件可使所述细长构件相对于所述管轴体轴向移动。 12. The apparatus according to claim 1, wherein the elongate body comprises a tubular shaft, said tubular shaft includes a lumen and said lumen includes a first threaded portion, wherein said actuator comprising an elongate member, said elongate member is in the lumen, and includes a second threaded portion for engagement with said first threaded portion sliding fit, by rotating the elongated member allows the fine member relative to the long axis of the tube body to move axially.
13.根据权利要求1所述的装置,其中所述细长体包括一管状体,并且其中所述定位片是通过在所述管状体的第一末端区切出纵向的狭槽来形成。 13. The apparatus according to claim 1, wherein the elongate body comprises a tubular body, and wherein said positioning sheet is cut through a longitudinal slot in the first end region of the tubular body is formed.
14.根据权利要求13所述的装置,其中所述支撑臂是部分切除所述各个定位片的一部分形成的,因而所述支撑臂限定了与所述各个定位片保持相连的第一末端,以及与所述致动器相连接的第二末端。 14. The apparatus according to claim 13, wherein said support arm is formed in a portion of the cut portion of each positioning piece, so that said support arm defining a first end of the respective positioning piece holding and connected, and and said actuator is connected to a second end.
15.根据权利要求13所述的装置,还包括有多个中间定位片,该定位片形成于所述细长体上的所述第一和第二末端区之间的中间位置上,所述中间定位片具有从所述轴向折叠状态转变到所述完全横向膨胀状态的可膨胀性。 15. The apparatus according to claim 13, further comprising positioning a plurality of intermediate sheets, the positioning piece is formed at an intermediate position on said elongate body first and second ends of the zone between the positioning an intermediate sheet having a transition from the axial collapsed state to the expanded state may be completely laterally expandable.
16.根据权利要求15所述的装置,其中所述中间定位片包括有从其中延伸出来的支撑臂,所述支撑臂连接到所述致动器上来控制所述中间定位片从所述折叠状态转变到所述膨胀状态。 16. The apparatus according to claim 15, wherein said intermediate sheet comprises positioning which extends out from the support arm, the support arm is connected up to the control of the actuator from said intermediate sheet positioned folded state transition to the expanded state.
17.根据权利要求1所述的装置,其中所述细长体包括一在所述第一和第二末端区之间的中间区,其中所述多个定位片包括第一组定位片,并且所述多个支撑臂包括有与所述第一组定位片相连的第一组支撑臂,该装置还包括有:第二组定位片,从所述细长体中间区延伸出,所述定位片能可被控制地从通常的一轴向折叠状态膨胀变换到一完全膨胀状态;以及第二组支撑臂,与所述第二组定位片相连;其中所述致动器与所述支撑臂相连接,所述致动器可以相对所述细长体轴向移动,从而使得所述第一和第二组支撑臂控制所述第一和第二组定位片在所述折叠状态和膨胀状态间变换。 17. The apparatus according to claim 1, wherein the elongate body includes an intermediate region in the region between the first and second ends, wherein said plurality of positioning sheet comprises a first set of positioning piece, and said plurality of support arms comprises a first set of said positioning piece coupled to a first set of support arms, the apparatus further comprising: a second set of positioning sheet from said intermediate region extending elongate body, said positioning sheet can be controlled from a generally axial collapsed state to an expanded fully expanded state change; and a second set of support arms, connected to said second set of positioning sheet; wherein said actuator and said support arm connected to the actuator may cause axial movement relative to the elongate body such that the first and second set of support arms control said first and second set of tabs on the collapsed state and expanded state between transitions.
18.根据权利要求17所述的装置,其中所述细长体包括有一管轴,所述管轴包括一延伸于所述近端区和远端区之间的管腔,并且其中所述致动器包括:一细长构件,容纳于所述管腔内;以及第一和第二轴环,连接到所述细长构件并分别与所述第一和第二组支撑臂相连,其中所述细长构件相对所述管轴的转动能引起所述第一和第二轴环轴向移动,从而使得所述第一和第二组支撑臂控制所述定位片在所述折叠状态和膨胀状态间变换。 18. The apparatus according to claim 17, wherein the elongate body comprises a tubular shaft, the shaft comprises a tube extending between said proximal region and the distal region of the lumen, and wherein said actuator the actuator comprising: an elongate member received within the lumen; and a first and a second collar connected to the elongate member and connected to said first and second set of support arms, respectively, wherein said elongated member rotating relative to the tube axis to cause the first and second collar to move axially, such that said first and second sets of support arms to control the positioning of the sheet in the folded state and expanded between state transitions.
19.根据权利要求18所述的装置,其中所述第二组定位片从所述管轴的远端端部区向远端延伸。 19. The apparatus according to claim 18, wherein said second set of positioning piece extending from the distal end region of the tube axis toward the distal end.
20.根据权利要求19所述的装置,其中所述细长构件包括螺纹旋向相反的第一和第二螺纹区,而且其中所述第一和第二轴环分别通过螺纹连接到所述第一和第二螺纹区。 20. The apparatus according to claim 19, wherein the elongate member comprises a threaded opposite first and second threaded region, and wherein said first and second shafts are respectively connected to the first ring threadably first and second threaded area.
21.根据权利要求17所述的装置,其中所述第二组定位片位于所述细长体的中间区。 21. The apparatus according to claim 17, wherein said second set of positioning of the sheet in the middle region of the elongate member.
22.一种稳定骨骼装置的制作方法,包括:准备一包括第一和第二末端区的细长管状体,且两个末端区之间限定一纵轴;在所述第一末端区形成定位片,所述定位片具有与所述管状体的第一末端区保持连接的第一末端以及相对于所述第一末端轴向布置的第二末端,所述第二末端能相对所述管状体自由移动;在所述定位片上形成支撑臂,所述支撑臂具有能相对所述定位片自由移动的第一末端和保持连接在所述定位片上的第二末端;并且把所述支撑臂的第一末端与一致动器相连,所述致动器能相对所述管状体轴向移动,以控制所述定位片的第二末端相对所述纵轴横向向外膨胀。 22. A bone stabilizing device manufacturing method, comprising: preparing an elongate tubular body comprises a first and a second end region, and between the two end regions defining a longitudinal axis; formed positioned at the first end region sheet, said sheet having a first end and positioning the first end region of the tubular body and remains connected with the first end to the second end axially disposed, said second end of said tubular body can be relatively freedom of movement; forming a support arm on the orientation film, the support arm has a second end of the sheet can be positioned freely movable relative to the first end and stay connected on the orientation film; and the first arm of said support One end is connected with the actuator, the actuator can be moved axially with respect to said tubular body, to control a second end of the positioning plate relative to said longitudinal axis laterally outwardly expanded.
23.根据权利要求22所述的方法,其中所述形成定位片的步骤包括在所述第一末端区生成纵向狭槽。 Step 23. The method of claim 22, wherein said positioning sheet forming comprises generating longitudinal slot in said first end region.
24.根据权利要求22所述的方法,其中所述形成支撑臂的步骤包括部分切除相应定位片的一部分。 24. The method according to claim 22, the step portion of the support arm comprises positioning the respective partial hepatectomy wherein said sheet is formed.
25.根据权利要求22所述的方法,其中所述致动器包括一细长构件和一第一轴环,而且其中所述连接步骤包括:将所述细长构件插入到所述管状体的一轴向管腔中;将所述第一轴环拧上所述细长构件,直到所述轴环接近所述支撑臂的第一末端;以及将所述支撑臂的第一末端与所述第一轴环相连接。 25. The method according to claim 22, wherein said actuator comprises an elongate member and a first collar, and wherein said connecting step comprises: said elongated member is inserted into the tubular body an axial lumen; tighten the upper ring of the first elongate shaft member, until said collar proximate the first end of the support arm; and a first end of said support arm and said The first collar connected.
26.根据权利要求25所述的方法,其中所述管状体包括一在所述管腔内的螺纹部分,而且其中所述插入细长构件的步骤中包括将所述细长构件的螺纹部分拧入所述管状体的螺纹部分。 26. The method according to claim 25, wherein said tubular body comprises a threaded portion of said lumen, and wherein the step of inserting the elongate member comprises a threaded portion of the elongated member is screwed into the threaded portion of the tubular body.
27.根据权利要求26所述的方法,还包括至少在所述管状体的第二末端区和中间部二者之一上形成所述定位片和支撑臂。 27. The method according to claim 26, further comprising forming at least said positioning plate and said support arm in the second end region of the tubular body and the intermediate portion of one of both.
28.根据权利要求27所述的方法,还包括:将一第二轴环穿拧上所述细长构件,直到所述第二轴环贴近位于所述管状体的第二末端区上的支撑臂;以及将位于所述第二末端区的支撑臂连接到所述第二轴环上。 28. The method according to claim 27, further comprising: said elongate member is screwed through a second collar, said second collar until close to the second end of the support area is located on said tubular body arm; and said second end region located on the support arm is connected to said second collar.
Description  translated from Chinese
可膨胀的矫形装置 Inflatable orthopedic device

本申请是下列相关申请的接续,即1999年10月22日提交、申请序列号为09/426,563的美国专利申请,并于2001年7月17日作为美国专利第6,261,289号公告,其要求申请日为1998年10月26日的第60/105,593号美国临时申请、和2000年10月19日提交并于2001年4月26日以公布号WO 01/28443公开的第PCT/IL00/00666号PCT申请的优先权,其内容结合于此作为参考。 This application is a continuation of the following related applications, namely October 22, 1999 to submit, Application Serial No. 09 / 426,563, U.S. Patent Application, and on July 17, 2001 as US Patent No. 6,261,289 bulletin, which requires the filing date as No. 60 / 105,593 US Provisional Application October 26, 1998, and and 19 October 2000 and submitted to the April 26, 2001 in Publication No. WO 01/28443 discloses the No. PCT / IL00 / 00666 PCT Application priority, which is incorporated herein by reference.

发明领域本发明涉及用于骨折外科治疗和病态骨骼预防性治疗的矫形装置,特别是可膨胀的髓内装置,以及制作和使用这些装置的方法。 Field of the Invention The present invention relates to surgical treatment and pathological bone fractures prophylactic treatment of orthopedic devices, especially expandable intramedullary device, and methods of making and using these devices.

背景技术 Background

肢部骨骼的骨折一直是用内部固定装置来治疗,比如位于骨骼表面的金属板、钉入骨折的骨骼髓管中的钉子、和/或把骨折的骨骼的两端固定在一起的螺丝钉。 Limb bone fracture internal fixation devices have been used to treat, for example, a metal plate located on the surface of the bone, driven into the medullary canal of the bone fracture nail, and / or put together the two ends of the fracture of the bone screws. 这些内部固定装置可以为骨折的骨骼提供适当的结构刚性和/或稳定性,而不会损及某些所希望的用来刺激骨骼细胞的应变(the strain desired to stimulate bone cells)。 These internal fixation devices may provide adequate structural rigidity and / or stability of bone fractures, without compromising certain desirable to stimulate bone cell strain (the strain desired to stimulate bone cells).

一种髓内固定法是用于治疗长骨骨折的传统疗法,采用髓内钉固定住骨折,而不会影响到骨膜。 One kind of intramedullary fixation for the treatment of long bone fractures of traditional therapy, the use of intramedullary nailing live fracture, without affecting the periosteum. 这种方法可以以封闭方式实现,骨折的骨骼在恢复的过程中可以得到官能性的使用(包括承受重量)。 This method can be achieved with a closed fracture of the bones in the recovery process can be functional use (including bear weight). 每种骨骼插入髓内钉的手术方法略有不同,对此在整形外科文献中有充分的描述。 Each bone intramedullary nail inserted slightly different surgical methods, which have fully described in the orthopedic literature.

传统的髓内固定方法涉及到一些问题,包括旋转稳定性不足,某些骨折类型中折裂处塌陷,和/或不需要的钉子留滞。 The traditional intramedullary fixation method involves a number of issues, including inadequate rotational stability, some type of fracture at the collapse of the fracture, and / or unwanted nail lag. 此外,尽管实际的骨骼形状通常包括某种程度的弯曲,但是用于修复骨折的髓内钉通常却是直的。 In addition, although the actual shape of the bone typically includes some degree of bending, but to repair fractures the intramedullary nail is generally straight. 而且,髓内固定法放入的联锁螺钉可能会碰到髓内钉,造成一些问题。 Moreover, interlocking intramedullary fixation screws into the nail may hit, causing some problems. 特别是,用于长骨的传统的髓内固定钉会包括一个刚性结构(中空的或是实心的),刚性结构的端部用横向穿过骨壁面和钉子自身的额外螺丝钉固定。 In particular, the traditional nail for intramedullary fixation of long bones will include a rigid structure (hollow or solid), the ends of the rigid structure through the bone with a lateral wall and nail their extra screws. 这个额外的步骤通常使手术时间更长而且更复杂,并且会需要额外的皮肤切口和/或更长时间地使用图象增强器(X射线)。 This extra step is usually to make longer and more complex operation, and will need additional skin incisions and / or more prolonged use of an image intensifier (X-rays). 此外,由于这些螺钉,在骨端之间会出现不希望的裂隙,这些螺钉是一直留在其中的,除非在新的手术中取出。 In addition, since the screws between the ends of the bones in undesirable cracks occur, these screws are remained in them, unless removed in the new operation. 同时,合成结构在某些情况下太僵硬,缺少所希望的弹性。 Meanwhile, the resultant structure is too rigid in some cases, lack the desired flexibility. 在被污染的骨折中,尽管努力清理骨折处,金属性的髓内钉仍可能通过整条髓管扩散污染,并可能导致骨骼感染。 In contaminated fractures, despite efforts to clean up the fracture, metallic nail may still medullary canal through the entire diffusion pollution, and may lead to bone infection.

髓内固定法的最新进展已在尝试解决这些问题中的有些问题。 Latest Development of intramedullary fixation has been trying to address these issues in some problems. 例如,Beyar在PCT公开文献No.WO98/38918中提出了三种结构设计:(1)在髓管中膨胀的固体金属片;(2)由末端周向连接的肋条构成的网状结构;以及(3)插入髓管便会膨胀的气囊结构。 For example, Beyar proposed in PCT Publication No.WO98 / 38918 in the design of three structures: (1) a solid metal sheet is expanded in the medullary canal; (2) from the end of the net-like structure of ribs circumferentially connected configuration; and (3) will be inserted into the medullary canal expandable balloon structure. 然而前两种结构在骨骼干骺端中不能提供稳固支撑。 But in the last two structures in the metaphyseal bone can not provide firm support. 特别是,这些结构不能在它们的末端膨胀,因为所述结构的总膨胀受到髓管的骨干部分的周缘的限制。 In particular, these structures can not be expanded at their ends, because the total expansion of the structures is limited portion of the periphery of the medullary canal of the backbone. 气囊结构的效用也有限制,因为一旦插入且膨胀,其体积就被固定,当它膨胀时会影响骨骼的血液供应,妨碍再生或恢复,和/或不能通过调整来改变其在髓管中的形状。 Utility airbag structure is also limited, because once inserted and expanded, the volume is fixed, when it expands affects the blood supply of bone, prevent regeneration or recovery, and / or can be adjusted to change its shape in the medullary canal of .

Vicenzi在美国专利No.5,281,225中披露了一种包括多个通过一个柄部连接在一起的可变形的弹性杆的结构。 Vicenzi discloses a structure comprising a plurality of connected together by an elastically deformable shank rod in the US Patent No.5,281,225. 当插入骨折骨骼的髓管时,杆末梢端部向外膨胀进入到髓管的末端,以将Vicenzi结构固定在骨骼内。 When inserted into the medullary canal of a fractured bone, the distal end portion of the rod into the end of the outward expansion of the medullary canal, to Vicenzi structure is fixed within the bone. 然而,这是一种被动装置,它刚一展开就自动膨胀,而且不能可控制地膨胀。 However, this is a passive device, it just opened it automatically expands control and can not be expanded. 另外,上述Vicenzi结构不能在髓管中膨胀,因而与髓管壁面不能多点接触。 Further, the structure can not Vicenzi medullary canal expansion, and therefore can not multi-point contact with the wall surface marrow. 结果,Vicenzi结构不能确保沿着断裂骨骼的横截面和旋转面的结构稳定性。 The results, Vicenzi structure can not ensure a cross-section along the broken bones and the rotating surface of the structural stability.

因此,可以认为能够提供和/或确保骨折的骨骼稳定性的髓内装置是有效的。 Therefore, it is considered capable of providing and / or to ensure the stability of bone fractures intramedullary device is effective.

发明概述本发明涉及用于外科治疗骨折和预防性治疗病态骨骼的矫形装置,尤其是可膨胀的髓内装置,以及制造和植入它们的方法。 SUMMARY The present invention relates to surgical treatment of bone fractures and prophylactic treatment of morbid orthopedic devices, especially expandable intramedullary devices, and methods for their manufacture and implantation.

根据本发明的一个方面,用于稳定骨骼的装置包括一个细长体,具有第一末端区和第二末端区,两个末端区之间限定一个纵轴。 According to one aspect of the present invention, the means for stabilizing bone includes an elongate body having a first end region and a second end region, defines a longitudinal axis between two end regions. 多个定位片(spline),从第一末端区伸展出来,这些定位片包括连接到细长体的第一末端区的第一末端,和与第一末端区相离的第二末端,定位片的第二末端能可控制地从通常的轴向折叠状态转变到完全横向膨胀状态。 A plurality of positioning pieces (spline), extending out from the first end zone, which includes a first end positioning piece elongate body connected to the first end region, a second end, the first end of the positioning plate and away from one region of The second end of the shift can be controlled from the normal axial transverse folded state to a fully expanded state. 多个支撑臂,与定位片相连接,以及一个致动器,连接在支撑臂上,致动器可以相对于细长体轴向移动,从而使得支撑臂控制定位片的第二末端从折叠状态变为膨胀状态。 A plurality of support arms, and connected to positioning piece, and an actuator connected to the support arm, the actuator may move axially relative to the elongate body, so that the support arms control orientation film of the second end from the folded state into an expanded state.

在一个实施例中,该细长体是一个管轴,具有延伸在近端端部区和远端端部区之间的管腔,该致动器包括一个被容纳到管腔中的细长构件,并且最好是通过匹配的螺纹区,滑动连接到管轴。 In one embodiment, the elongate body is a pipe shaft having a lumen extending between the proximal end region and the distal end region, which comprises an actuator accommodated in the elongated lumen member, and preferably by matching the threaded region, slidably connected to the tube axis. 一个轴环连接到细长构件和支撑臂上。 A collar connected to the elongated member and the support arm. 最好是,细长构件包括有一个螺纹区,在螺纹区上拧上该轴环,从而细长构件相对于管轴的转动引起轴环的轴向移动,从而使得支撑臂控制定位片在折叠和膨胀状态间变化。 Preferably, the elongate member comprises a threaded zone, screwed on the threaded zone of the collar, so that the elongate member is rotated relative to the tube axis causes the collar to move axially, so that the support arm to control positioning piece folding and an expanded state between changes.

根据本发明的另一方面,用于稳定骨骼的装置包括有一个细长体和一个中间区,细长体有第一末端区和第二末端区,这两个末端区限定了位于其间的一个纵轴,中间区是在第一和第二末端区之间。 According to another aspect of the present invention, apparatus for stabilizing bone includes an elongate body and an intermediate region, the elongate body having a first end region and a second end region, the two-terminal region defining therebetween a a longitudinal axis, an intermediate region between the first and second end zone. 第一组定位片从第一末端区延伸出来,这些定位片能可被控制地从一种通常的轴向折叠状态转变为一种完全横向膨胀状态。 The first set of positioning tab extending from the first end zone out, these orientation film can be controlled to change from a generally axial collapsed state to an expanded state completely laterally. 第二组定位片从细长体上远离近端端部区域的一个区域延伸出来,这些定位片能可被控制地从通常的一种轴向折叠状态转变为一种横向膨胀状态。 The second set of positioning pieces away from the proximal end of the elongate body region extending from an area, these orientation film can be controlled to change from the normal state of an axially folded state as a lateral expansion.

第一和第二组支撑臂分别与第一和第二组定位片相连接,并且有一个致动器连接到这些支撑臂。 The first and second set of support arms are connected to the first and second sets of positioning piece, and there is an actuator connected to the support arm. 致动器可相对细长体轴向移动,从而使得第一和第二组支撑臂控制定位片在折叠和膨胀状态间变化。 The actuator may move axially relative to the elongate body, so that the first and second set of support arms control positioned between the folded sheet changes and expanded state.

最好是,该细长体是一个管轴,包括有一个延伸于近端端部区和远端端部区之间的管腔,并且该致动器包括一个容纳于管腔中的细长构件。 Preferably, the elongate member is a tube axis, includes a portion extending between the proximal region and distal end regions of the lumen, and the actuator includes an elongated lumen housed in member. 第一和第二轴环分别连接到细长构件并连接到第一、第二组支撑臂。 The first and second collar are connected to the elongate member and connected to the first, the second set of support arms. 细长构件相对于管轴的转动,引起第一、第二轴环的轴向移动,从而使得第一、第二组支撑臂控制定位片在折叠和膨胀状态间变化。 The elongated member with respect to the axis of rotation of the tube, causing the first and second axial movement of the collar, so that the first and second set of support arms control and positioned between the folded sheet in the expanded state changes.

在一个实施例中,第二组定位片从管轴的远端端部区域向远端延伸。 In one embodiment, the second set of positioning piece extending from the distal end region of the tube to the distal end of the shaft. 该细长构件可以包括螺纹旋向相反的第一和第二螺纹区。 The elongate member may comprise a threaded opposite first and second threaded region. 第一和第二轴环分别与第一和第二螺纹区通过螺纹相连接。 The first and second collar with the first and second threaded region are connected by threads. 由于反向螺纹设置,细长构件的转动会使轴环向反方向移动。 Since the reverse thread setting, turn the collar will elongate member to move in the opposite direction. 因此,朝第一个方向转动细长构件会使轴环相互离开从而使定位片膨胀,而朝相反方向转动细长构件会使轴环相互靠近从而使定位片折叠。 Thus, towards the first elongate member is rotated in one direction causes the collar away from each other so that the locating tab expansion, but in the opposite direction of rotation of the elongate member causes the collar positioned close to each other so that the sheet is folded.

在一个可选的实施例中,第二组定位片可以被置于管轴的中间区。 In an alternative embodiment, the second set of positioning pieces can be placed in the middle area of the tube axis. 在一个进一步的可选实施例中,除了上面所描述的之外,可以沿着管轴设置额外的一套定位片。 In a further alternative embodiment, except as described above, you can set additional set of positioning pieces along the tube axis. 因此,一个单独的致动器可以用于膨胀单个装置上的多组定位片。 Thus, a single actuator may be used for multi-group orientation film on the expansion of a single device. 这些定位片可以有不同的形状和/或长度,从而使得所述装置可以植入一个既定形状的骨腔内。 The orientation film can have different shapes and / or lengths, so that the device may be implanted in the bone cavity of a predetermined shape.

可选地,根据本发明的一个装置可以具有一个轴向延伸部分,比如,从装置的近端端部向近端延伸到超出定位片。 Alternatively, a device according to the invention may have an axially extending portion, for example, from the proximal end of the device extends beyond the proximal end positioning piece. 例如,细长构件可以向近端延伸到管轴的第一末端上的定位片之外,或者管轴本身可以包括一个延伸部分。 For example, the elongate member may extend proximally beyond the first end of the tube sheet positioned on the shaft, the shaft or the tube itself may include an extension. 在轴向延伸部分中可以有一些孔眼,钉子、螺丝钉、或者其它固定元件穿过这些孔眼可以提供额外的横向支撑。 Axially extending portion may have some perforations, nails, screws, or other fixed elements through these apertures can provide additional lateral support. 进一步可选地,指示元件可从该装置向近端延伸,或者在植入后细长构件可以被延伸以促进装置的定位。 Further alternatively, the indicating element may extend proximally from the device, or after implantation of the elongate member may be extended to facilitate the positioning device.

根据本发明的又一方面,提出了一种稳定骨骼装置的制造方法。 According to yet another aspect of the present invention proposed a method for manufacturing bone stabilizing device. 提供一个包括有第一和第二末端区的细长管轴,这两个末端区之间限定一条纵轴。 Providing an elongate tube comprising a first shaft and a second end region, defines a longitudinal axis between two end regions. 形成的定位片具有保持连接在管状体第一末端区的第一末端和相对于第一末端轴向布置的第二末端,第二末端能相对于管状体自由移动。 Positioning piece is formed having a tubular body holding a first end connected to the first end region and a second end with respect to a first end axially arranged, with respect to the second end of the tubular body can move freely. 更佳地,该定位片通过在第一末端区切出纵向狭槽而形成。 More preferably, the positioning piece by cutting in the first end region of the longitudinal slot is formed. 支撑臂在定位片中形成,支撑臂具有可相对定位片自由移动的第一末端和保持连接在定位片上的第二末端。 Positioning the film formed in the support arm, the support arm having a first end piece can move freely relative positioning and holding a second end connected to the positioning tablets. 更佳地,支撑臂是由各自定位片的局部切除部分形成。 More preferably, the support arm is a partially cut-sheet formed by the respective positioning.

该支撑臂的第一末端可以与一个致动器相连接,该致动器可以相对于管轴轴向移动,用于使支撑臂相对纵轴横向向外弯曲,从而控制定位片的第二末端横向朝外。 A first end of the support arm can be connected with an actuator, causing the second end of the actuator shaft can move axially relative to the tube, the support arm for laterally bent outwardly relative to the longitudinal axis, thereby controlling the positioning plate laterally outward. 在一个优选实施例中,该制动器包括有一个细长构件和一个第一轴环。 In a preferred embodiment, the brake comprising an elongate member and a first collar. 细长构件被插入到管轴中的轴向管腔中,并且将第一轴环拧到细长构件上直到轴环靠近支撑臂的第一末端。 The elongated member is inserted into the axial lumen of the tube axis, and the first collar threaded onto the elongate member until the collar near the first end of the support arm. 然后将支撑臂的第一末端与第一轴环相连接。 Then the first end of the support arm is connected with the first collar.

在一个优选的实施例中,管轴包括有一个位于管腔中的内螺纹部分,并且细长构件也包括一个匹配的螺纹区,这个配套的螺纹区与管轴的螺纹部分可滑动地啮合。 In a preferred embodiment, the tube shaft includes a threaded portion located within the lumen, and the elongate member also includes a matching threaded region, the threaded region matching threaded portion of the tube is slidably engaged with the shaft. 因此,除细长构件的受控旋转外,细长构件相对于管轴的轴向移动会被限制。 Thus, in addition to the controlled rotation of the elongate member, the elongate member is axially movable relative to the tube axis is restricted.

可选地,第二组(或另外组)的定位片和支撑臂在管轴的其它区域形成,比如,在管轴的第二末端区或者中间区上的一个区域形成。 Alternatively, the second group (or another group) positioning piece and support arms in other regions of the tube axis is formed, for example, an area on the second end zone or intermediate zone tube axis formation. 在这种情况下,可以将一个第二轴环拧到细长构件上直到第二轴环靠近第二组支撑臂,并且第二组支撑臂和第二轴环相连接。 In this case, a second collar may be threaded onto the elongate member until the second collar adjacent the second set of support arms, and a second set of support arms and a second collar connected.

根据本发明所述的装置,可以采用传统步骤插入一个先前形成的入口中,例如,将定位片折叠后插入诸如股骨骨骼的髓管中。 Apparatus according to the present invention can be inserted into the entrance of a traditional step previously formed, for example, the sheet is folded inserted after positioning the femur bone marrow, such as a tube. 最好是,采用传统方法首先将一条引线穿过入口进入骨骼的髓管中,并且延伸到骨骼的远端段。 Preferably, the first by a conventional method to lead through the entrance into a medullary canal of the bone, and extending to the distal end of the bone segment. 然后可以将该装置沿着引线插入到髓管中。 The device can then be inserted into the medullary canal along the wire. 在插入所述装置之后,引线就可以取出。 After insertion of the device, the lead can be removed.

该装置一旦完全插入到髓管中,致动器就被启动,例如,将一个工具插入到入口中使得定位片膨胀到膨胀状态,以使得定位片可以与内部的骨骼或其它组织充分接合,从而使该装置相对骨骼充分固定。 Once the device is fully inserted into the medullary canal, the actuator can be started, for example, a tool is inserted into the inlet such that the positioning sheet expanded to an expanded state, so that the sheet may be positioned to fully engage the internal bone or other tissue, and thus so that the device relative to the bone fully fixed. 因此,该装置可以防止植入此装置的骨折骨骼片断轴向移动、弯曲、和/或彼此相对转动。 Thus, the apparatus may be implanted in a fractured bone fragment prevents axial movement of the device, bending, and / or relative rotation to each other. 可选地,如果希望增加稳定性,可以采用超出定位片的延伸部分和固定装置,例如,螺丝钉或髓内钉等,可横向植入骨骼中,并穿过延伸部分中的孔眼来进一步固定骨骼片断。 Alternatively, if you want to increase the stability, and the fixing portion can extend beyond the positioning plate means, e.g., screws or intramedullary nail, the bone can be implanted laterally, and extending through the aperture portion to further secure the bone clips.

在骨折愈合后,该装置可用传统的处理方法取出。 After healing, the device removed by conventional treatment methods. 在该取出过程中,引入一个工具来启动制动器并控制定位片在从骨骼取出前回到折叠状态。 In the take-out process, the introduction of a tool to initiate and control the positioning piece brake before removing from the bones back to the folded state.

本发明的其它目的和特征结合附图通过下面的描述将显得非常清楚。 Other objects and features of the present invention are described below with reference to very, very clear.

附图简要说明图1-3分别是一根股骨、一根胫骨和一根肱骨的剖面侧视图。 Brief Description of the Figures 1-3 are a femur, a tibia and a sectional side view of the humerus.

图4A和4B分别是根据本发明的髓内装置的第一实施例透视图,定位片分别处于折叠状态和膨胀状态。 4A and 4B are a perspective view of a first embodiment of the intramedullary device according to the invention, the positioning pieces are in a folded state and an expanded state.

图5A和5B分别是图4A和4B中装置的一个末端的透视图,分别示出了定位片在末端的折叠状态和膨胀状态。 5A and 5B are a perspective view of one end of the apparatus of FIGS. 4A and 4B, respectively showing a positioning piece in the folded state and an expanded state ends.

图6A和6B是一个包括了被图4A和4B中所述装置稳定了的骨折的股骨剖视图。 6A and 6B is a cross-sectional view includes Figures 4A and 4B are a means to stabilize the fracture of the femur.

图7A和7B是根据本发明的髓内装置的第二实施例的透视图,定位片分别处于折叠状态和膨胀状态。 7A and 7B is a perspective view of an embodiment of the present invention, the intramedullary device according to a second, positioning pieces are in a folded state and an expanded state.

图8A和8B分别是图7A和7B中装置的一个末端的透视图,分别示出定位片在末端的折叠状态和膨胀状态。 8A and 8B are a perspective view of one end of the apparatus of FIG. 7A and 7B, respectively positioning piece shown in the folded state and an expanded state ends.

图9A和9B是一个包括了被根据本发明的髓内装置的第三实施例固定了的骨折的股骨剖视图。 9A and 9B are a cross-sectional view comprising a fixed according to a third embodiment of the apparatus of the present invention, the intramedullary femoral fractures.

图10A、10B、11A、和11B是一个包括了被根据本发明的髓内装置的其它可选实施例固定了的骨折的股骨剖视图。 Figure 10A, 10B, 11A, and 11B is a cross-sectional view is included in the intramedullary device according to another alternative embodiment of the present invention, the fixation of the fracture of the femur.

图12是根据本发明的髓内装置的第四优选实施例的透视图,其定位片处于膨胀状态。 12 is a perspective view of an intramedullary device according to a fourth preferred embodiment of the present invention, the orientation film in an expanded state.

图13A和13B是图12中的装置的一个末端的透视图,示出定位片分别处于折叠状态和膨胀状态。 13A and 13B is a perspective view of one end of the apparatus of FIG. 12, showing the positioning pieces are in a folded state and an expanded state.

图14A和14B是图12和13中的装置的横截面侧视图,示出定位片分别处于折叠状态和膨胀状态。 14A and 14B are 12 and 13 in a cross-sectional view of the apparatus, showing the positioning pieces are in a folded state and an expanded state.

图15A-15D是透视图,示出根据本发明的在一个管体中形成定位片的方法。 FIG. 15A-15D is a perspective view showing the method of forming the orientation film in a tubular body according to the present invention.

图16是根据本发明的髓内装置的一可选实施例的透视图。 16 is a perspective view of an embodiment according to the intramedullary device of the present invention an alternative.

实施例的详细说明本发明可用于修复各种骨折的骨骼,如股骨、胫骨、或肱骨。 Detailed description of embodiments of the present invention can be used to repair fractures of various bones such as the femur, tibia or humerus. 这些骨骼的相关特性将参考图1-3作为背景描述。 These bone-related characteristics of the background as described with reference to Figures 1-3. 特别是参考图1,一块股骨100可以被分为六个解剖区:骨干或中间骨体102、近端的干骺端104、远端的干骺端106、近端的骨骺或头部108、远端的骨骺110、和股骨颈112。 In particular with reference to Figure 1, a femur 100 can be divided into six anatomical region: bone shaft or the intermediate body 102, proximal metaphysis 104, distal metaphysis 106, proximal epiphysis or head 108, distal epiphysis 110, 112 and the femoral neck. 股骨100是由一层坚固皮层114和髓腔116构成。 100 is composed of a layer of solid femoral cortex 114 and 116 constitute canal. 根据发明的目的,髓腔116包括一条髓管118,髓管穿过骨体102的中心和近端与远端的干骺端区域120和122、以及近端和远端的骨骺区124和126。 According to the purpose of the invention, the medullary cavity 116 includes a medullary canal 118, 102 through the bone medullary canal of the center and the proximal and distal metaphyseal areas 120 and 122, and the proximal and distal epiphysis regions 124 and 126 .

具体参考图2,一块胫骨140可以分为五个解剖部分:骨干或中间骨体142、近端的干骺端144、远端的干骺端146、近端的骨骺148、和远端的骨骺150。 With specific reference to Figure 2, a tibia 140 can be divided into five anatomical portions: bone shaft or intermediate member 142, proximal metaphysis 144, distal metaphysis 146, proximal epiphysis 148, and distal epiphysis 150. 如同该股骨100,胫骨140也由一层坚固皮层152和一个髓腔154构成。 100 as the femur, tibia 140 by a layer of hard skin 152 and 154 constitute a canal. 为便于说明的目的,髓腔154包括一根髓管156,髓管穿过骨体142的中心、近端与远端干骺端区域158和160、以及近端和远端的骨骺区域162和164。 To facilitate the purpose described medullary cavity 154 includes a medullary canal 156, the medullary canal through the central body 142 of the bone, the proximal and distal metaphyseal areas 158 and 160, and proximal and distal epiphyseal areas 162 and 164.

参见图3,一根肱骨170如同胫骨140一样可分为五个解剖区:骨干或中间骨体172、近端的干骺端或者颈174、远端的干骺端176、近端的骨骺或头部178、和远端的骨骺180。 Referring to Figure 3, a humerus 170 as a tibial 140 can be divided into five different anatomic zones: 172 backbone or middle bone, the proximal metaphyseal or neck 174, 176 metaphyseal distal, proximal epiphysis or head 178, 180 and distal epiphysis. 如同该股骨100和胫骨140,肱骨170由一层坚固的皮层182和一条髓腔184构成。 As the femur and tibia 100 140 170 by the humeral cortical layer of solid 182 and 184 constitute a canal. 为便于说明,髓腔184包括一条髓管186,髓管穿过骨干172的中心、近端和远端干骺端区域188和190、以及近端和远端的骨骺区域192和194。 For purposes of illustration, the canal 184 includes a medullary canal 186, the medullary canal through the center of the backbone 172, the proximal and distal metaphyseal regions 188 and 190, and the proximal and distal epiphysis regions 192 and 194.

应该强调的是股骨100、胫骨140、和肱骨170表示的是可以使用本发明装置的典型骨骼。 It should be emphasized that the femur 100 and tibia 140, and humerus 170 shows a device of the invention can be used in a typical bone. 除了股骨100、胫骨140、及肱骨170,本发明还可用于修复其它的骨折的骨骼,不偏离本发明所述的范围。 In addition to the femur 100, tibia 140, and humerus 170, the present invention may also be used to repair fractures of other bones, without departing from the scope of the present invention.

尽管股骨100、胫骨140、和肱骨170的髓管沿这些骨骼的骨干具有均匀的周缘,然而这些髓管还与更大的干骺端区域及骨骺区域相连通。 Despite the femur 100, tibia 140, and humerus 170 tube marrow bones along the backbone of a uniform circumferential edge, but these are also associated with greater medullary canal of the metaphyseal region and epiphyseal region communicating. 因而,由于这些髓腔末端的周缘大于中部的周缘,所以股骨100、胫骨140、及肱骨170的髓腔从整体来看,其周缘是变化的。 Thus, since the peripheral edge of the canal at the end of the middle edge is greater than the circumference, so the femur 100 and tibia 140, and humerus 170 canal Overall, its periphery is changing. 本发明的髓内装置是可逆式膨胀,比如,采用一个事先设定好的形状,使其适合骨髓腔的内部形状。 Intramedullary device of the present invention is a reversible expansion, for example, using a pre-configured shape to fit the shape of the internal cavity of the bone marrow. 运用本发明的髓内装置,可以旋转地锁住骨折骨的骨段,并且同时使得其它骨面得到足够的稳定性而不需用螺钉。 The use of intramedullary device of the present invention, can be rotated to lock the bone fracture bone segment, and at the same time make other facial required to get enough stability without screws. 如果需要螺钉,它们将和髓内装置一起使用。 If you need screws, they will be used with the intramedullary device. 该装置的侵害性极小,可以通过一个单独的切口作为入口植入。 The minimal invasive devices, through a single incision as entry implantation. 根据要固定的骨骼不同,必须采用不同长度及不同类型的髓内装置。 Depending on the bone to be fixed, they must be of different lengths and types of the intramedullary device. 这种髓内装置可以适用于各种骨骼周缘。 Such intramedullary device can be applied to a variety of bone peripheral edge.

所述髓内装置的应用方法与传统的用于骨骼如股骨、胫骨和肱骨的髓内钉的应用方法很相似,同时使骨折紧密复位后以及插入控制所需的X射线减少到最小。 The application method and the traditional intramedullary device such as the femur, tibia and humerus nail application method is very similar to the bone, but the fracture tightly controlled reset and insert the required X-rays is reduced to a minimum. 通过采用插入突破钉(Rush-type nails)的标准方法,髓内装置还可以应用于尺骨和桡骨。 By using a standard method for inserting a breakthrough nail (Rush-type nails), the intramedullary device can also be applied to the radius and ulna. 对于带有开放骨骺的不成熟的骨骼,该髓内装置可以通过在近端骺之下和在远端骺之上的入口插入,并且固定区域不包括所述端骺。 For the immature skeleton with open epiphysis, the intramedullary device can be below the proximal epiphysis and epiphyseal entrance on the far end is inserted and secured area does not include the end of the epiphysis. 长的髓内装置可被用在诸如包括有股骨和胫骨的膝盖并合的病例中。 Long intramedullary device can be used in it includes the femur and tibia in the knee, such as merging the cases. 短的髓内装置可用于诸如跖骨和掌骨的骨折。 Short intramedullary devices can be used, such as metatarsal and metacarpal fractures.

这种髓内方法,连同髓内装置的最小侵害特性,通常还可使骨折骨骼的骨膜不被触及。 This interlocking method, along with minimally invasive intramedullary device characteristics, usually also make a fractured bone periosteum not be touched. 除此之外,该髓内装置在不损害稳定性的条件下可以更轻,而且由于含有更少的金属使得在X射线下可以看得更清楚,并且和潜在用于配合增强治疗的其它类型的外部生物力学刺激的使用相适应。 In addition, the intramedullary device without damaging the stability can be lighter, but also because it contains less metal so that X-rays can be seen more clearly, and the potential for cooperation and to enhance other types of treatment The use of external biomechanical stimuli to adapt. 运用某些合金,这些构成髓内装置的材料可以保持无磁性,可以避免干扰最先进的图象技术,如MRI(磁共振成像)。 The use of certain alloys, these materials intramedullary device may remain non-magnetic to avoid interference of the most advanced imaging techniques, such as MRI (magnetic resonance imaging).

图4和图5示出髓内装置200的第一优选实施例,其包括一个管轴202,和近端端部与远端端部204,206,在这两个末端之间限定了一条纵轴208。 Figures 4 and 5 show a first preferred embodiment of the intramedullary device 200, which comprises a tube shaft 202, and a proximal end and a distal end portion 204, 206, between the two ends defining a longitudinal axis 208. 管轴202是一根具有一个环状的或其它形状的截面的普通管状体。 Tube shaft 202 is a generally cylindrical body having a circular cross section or of other shapes. 该管状体有一个实心的管壁,或者为了促进流体的流动穿过、为了使重量最小化、为了提供所需的柔性、和/或为了使管轴202能膨胀,在其上设有栅格或其它式样的孔眼(未示出)。 The tubular body has a solid wall, or in order to promote the flow of fluid through, in order to minimize weight, in order to provide the required flexibility, and / or to the tube shaft 202 can be expanded, with a grid on which or other patterns of perforations (not shown). 在一个可选实施例中,管轴202可以包括多个轴向刺片元件,这些元件通过一个网状体或其它互连结构相互连接,类似于申请序列号为No.09/426,563中所描述和示出的实施例,其结合于此供参考。 In an alternative embodiment, the tube shaft 202 may include a plurality of axial spines sheet elements which are interconnected by a mesh body or other interconnect structures, similar to Application Serial No. No.09 / 426,563 described and illustrated embodiment, which is incorporated herein by reference.

如图所示,多个定位片210从管轴202近端端部204伸出,并且最好是从管轴202的近端端部204和远端端部206都伸出。 As shown, a plurality of positioning pieces 210 from the proximal end of the tube 204 shaft 202 extends, and is preferably from the proximal end of the tube shaft 204 and the distal end portion 206 are projected 202. 定位片210在通常轴向折叠的状态(如图4A和5A所示)和完全横向膨胀的状态(如图4B和5B所示)之间膨胀。 Positioning piece 210 is generally axial expansion between the folded state (FIG. 4A and 5A) and completely laterally expanded state (Fig. 4B and 5B). 定位片210可以是如图所示的完全扁平的条带,也可以是圆线、细丝或其它能呈现出折叠和膨胀状态的结构。 Positioning tab 210 may be completely flat band strip as shown, or may be round wire, the other filaments can be folded and expanded state showing a structure or.

如图5A和5B清楚所示,每一个定位片210都包括有一个与管轴202相连接的第一末端区210a,和一个与轴环212相连接的第二末端区210b。 5A and 5B clearly shown, each positioning tab 210 has a first end region comprises a shaft 202 connected to the tube 210a, 210b and a second end region 212 with the collar connected. 定位片210的末端区210a和210b可通过诸如铰链等(未示出)分别连接到管轴202和轴环212上。 Location blade tip area 210 210a and 210b by such hinge (not shown) are connected to the tube axis 202 and a collar 212. 可选地,末端区210a和210b可与管轴202和/或212整体构成,并且足够柔软可以弯曲,以适应在折叠状态和膨胀状态之间运动。 Alternatively, the end zone 210a and 210b may form the tube shaft 202 and / or 212 as a whole, and flexible enough to be bent to fit between a collapsed state and an expanded state movement. 因此,例如,管轴202、定位片210、和轴环212可以由单节管体构成,定位片其材料适于用本领域普通技术人员所知的传统方法进行切除以形成定位片210。 Thus, for example, the tube axis 202, positioning pieces 210, and the collar 212 may be formed from a single tube, positioning pieces of the material is suitable for use traditional methods to those of ordinary skill in the art will be cut to form a positioning piece 210.

每一个定位片210还包括有一个中间区或弯折区210c,弯折区可以相对纵轴208向外充分地横向伸展,以限定膨胀状态。 Each positioning tab 210 further includes an intermediate zone or bent zone 210c, the bent region can sufficiently outwardly relative to the longitudinal axis 208 extending transversely to define the expanded state. 参见图5A所示,在折叠状态中,定位片210的第一和第二末端区210a、210b通常相互毗连排列,并且充分平行于纵轴208延伸。 Referring to FIG. 5A, in the folded state, a first orientation film 210 and second end regions 210a, 210b are arranged adjacent to each other normally, and extending substantially parallel to the longitudinal axis 208. 最好是,轴环212的直径充分小于管轴202的直径,从而轴环212在折叠状态时可放置在定位片210中。 Preferably, the diameter of the collar 212 is substantially smaller than the diameter of the tube axis 202, thereby collar 212 in the folded state can be placed in the positioning piece 210. 因此,在折叠状态下,中间区域210c通常和管轴202的横截面是同延的(coextensive)。 Accordingly, in the folded state, the intermediate region 210c and the tube axis is usually cross-section 202 is coextensive (coextensive).

参见图5B所示,在膨胀状态下,轴环212轴向位移,即远离管轴202。 Referring to Figure 5B, in the expanded state, the axial displacement of the collar 212, i.e., away from the axis of the tube 202. 这一动作使第二末端区210b位移,因此引起定位片210的中间区210c充分向外横向移动。 This action causes the displacement of the second end region 210b, thereby causing the intermediate section 210 of the positioning piece 210c fully outward laterally. 因此,在膨胀状态中,定位片210限定了一个完全大于管轴202直径的直径。 Thus, in the expanded state, the positioning piece 210 defines a diameter greater than the full diameter of the tube shaft 202.

如图6A和6B所示,在一个可选实施例中,定位片210'可以包括有在折叠状态下处于完全直线形的第一和第二末端区210a'、210b'和中间区210c'(图6A)。 6A and 6B, in an alternative embodiment, the positioning pieces 210 'may include in the folded state is completely linear first and second end regions 210a', 210b 'and the intermediate region 210c' ( Figure 6A). 第一末端区210a'与管轴202相连接,第二末端区210b'与轴环212相连接。 First end region 210a 'is connected to the tube axis 202, a second end region 210b' and the collar 212 are connected. 轴环212可以轴向移动,即朝管轴202移动,从而引起中间区210c'弯曲且向外充分地横向移动,直到达到膨胀状态为止(图6B)。 The collar 212 can be moved axially, i.e. towards the axis of the tube 202 to move, thereby causing the intermediate region 210c 'and bent laterally outwardly sufficiently to move up until the expanded state (FIG. 6B). 定位片210'可以包括有凹痕或薄弱区域(未示出),以提供枢接结构等,确保定位片按预先规定好的方式弯曲,也就是使得中间区210c'向外充分地横向移动。 Positioning pieces 210 'may include indentations or areas of weakness (not shown), to provide a pivoting structure, etc., to ensure good positioning piece according to a predetermined curved, i.e. so that the intermediate region 210c' is sufficiently moved laterally outwardly.

为了实现轴环212的可控移动,从而使定位片210可选择性膨胀和折叠,轴环212被连接在一个致动器上(未示出)。 In order to achieve a controlled movement of the collar 212, so that the orientation film 210 is selectively expanded and folded, collar 212 is connected to an actuator (not shown). 该致动器通常配置于管轴202中,在一优选实施例中,该制动器包括有一个细长控制件214(在图6B中可看到局部)和一个位于管轴202中的致动轴环(未示出)。 The actuator is generally disposed in the tube axis 202, in a preferred embodiment, the brake control member comprises an elongated 214 (in FIG. 6B can be seen locally) and a shaft 202 located in the tube actuation shaft ring (not shown). 控制件214可以是一个实心杆或管状件,它有一个与轴环212相连的外部末端216和一个位于管轴202内的内部末端(未示出)。 The control member 214 may be a solid rod or tubular member having an outer end 212 connected to the collar 216 and an inner end 202 located within the tube axis (not shown). 内部末端可以有一个螺纹区用于和致动轴环(未示出)上的匹配螺纹区紧密配合。 You can have a threaded inner end zone for and actuating collar (not shown) on the mating threads district close fit. 随着致动轴环在管轴202中转动,控制件214在管轴202中轴向移动,从而移动与定位片210相连接的轴环212。 With the actuating collar 202 in the tube axis of rotation, the control shaft 202 in the tube 214 moves axially, thereby moving and positioning piece 210 is connected to the collar 212. 这样,致动器通过轴环212与定位片210相连接,以在折叠和膨胀状态之间选择性地膨胀定位片210。 Thus, the actuator ring 212 by a shaft connected to the positioning piece 210, between the collapsed to the expanded state and the sheet 210 is selectively positioned expanded.

可选地,致动器可以是一个控制线(未示出),它连接到轴环212上并可以拉动,例如在管轴202中轴向拉动,来移动轴环212。 Alternatively, the actuator may be a control line (not shown), which is connected to the collar 212 and can pull, for example, 202 in the tube axis in the axial pull to move the collar 212. 在这个可选实施例中,定位片210将会偏向为折叠状态和膨胀状态中的一种状态,这种状态可以通过拉动控制线来获得,例如通过一个插入管轴202中的工具。 In this alternative embodiment, the orientation film 210 will be biased into a collapsed state and an expanded state state, this state can be obtained by pulling the control line, for example, by an insertion tube axis 202 tools. 致动器还可以采用本领域普通技术人员所知的变通方式,如机械的、液压的或者气动的致动器等。 The actuator may also be used by those of ordinary skill in the art flexible way, such as actuators, such as hydraulic or pneumatic machinery.

参见图6A和6B,装置200可以用在一根骨折的股骨100,例如,一个带有复合骨折128的骨折股骨的髓管118中。 Referring to Figure 6A medullary canal and 6B, device 200 may be used in a fracture of the femur 100, e.g., a complex fracture with a fracture of the femur 128 118. 可选地,该装置200还可以用在除股骨100以外的其它骨骼中,诸如前文所述的那些骨骼。 Alternatively, the device 200 can also be used in other bones other than the femur 100, such as those previously described skeleton. 首先,该装置200在定位片210折叠时可通过一个预先制成的入口130插入到髓管118中,如图6A所示。 First, the apparatus 200 when the positioning tab 210 is folded by a pre-formed inlet 130 into the medullary canal 118, shown in Figure 6A. 如果控制件214是管状的,一根引线或其它的细长元件(未示出)将首先导入髓管118中,装置200可以沿引线推进,即穿过控制件214的内腔(未示出)以便于装置200的定位。 If the control member 214 is tubular, a lead or other elongated element (not shown) is introduced into the medullary canal of the first 118, the device 200 can advance along the wire that passes through the lumen 214 of the control member (not shown ) to facilitate positioning the apparatus 200.

一旦装置200被完全插入到髓管118中,引线(如果使用了的话)就可以取出,然后从入口130引入一个工具(未示出)进入管轴202中用以接合并驱动装置200中的致动器。 Once the device 200 is fully inserted into the medullary canal 118, the lead (if any) can be removed, and then introduce a tool from the inlet 130 (not shown) into the tube axis 202 engage and drive means for causing 200 actuator. 例如,该工具可以是一个具有与致动轴环接合的旋转头的驱动工具。 For example, the tool may be a tool having a drive shaft and the actuation ring engages the rotating head. 该驱动工具可以采用手动、气动、和/或电动驱动来使致动轴环转动,从而使控制件214在管轴202中轴向移动,这样,移动轴环212直到在近端端部204上的定位片210膨胀为止。 The driving tool can be used manually, pneumatic and / or electric drive to make the actuation shaft ring is rotated, so that the control member 214 moves axially in the tube axis 202, so that the ring 212 until the proximal end of the movable shaft 204 The positioning tab 210 expansion so far. 膨胀的定位片210有足够的柔韧性和/或弹性以与近端的干骺端区120相适应。 Expanded orientation film 210 has sufficient flexibility and / or resiliency to the proximal metaphyseal region 120 to adapt. 因此,借助多个接触点,定位片210可以与最近的干骺端区120的壁面紧密地接合。 Thus, with a plurality of contact points, positioning tab 210 may be tightly engaged with the wall nearest the metaphyseal region 120. 这样可以在轴向和/或可扭转地固定所述装置200,进而固定骨折骨骼段。 This allows the axial and / or torsional securing the device 200, thereby fixing the fractured bone segments.

最好是,当在近端端部204上的定位片210膨胀时,在远端端部206上的定位片210同时膨胀。 Preferably, when the proximal end 204 of the positioning pieces 210 expands on the distal end 206 of the positioning piece 210 while expansion. 可选地,在远端端部206上的定位片210可以通过一个单独的制动器独立地膨胀,例如,使用一个与近端端部204所描述的相似的设备和方法。 Alternatively, the distal end 206 of the positioning piece 210 can be independently expanded by a separate brake, for example, using a method similar to the proximal end of the device and 204 described above. 在一个进一步可选实施例中,可以用一种仅包括一组定位片的髓内装置,类似于图10A-11B中所示的实施例。 In a further alternative embodiment, it may include only an intramedullary device with a set of positioning sheet, the embodiment shown in FIG. 10A-11B is similar.

在一个进一步可选实施例中,如果需要,与近端的一组定位片210相邻的轴环212可以从定位片210处进一步向近端延伸,而且在轴环中会有一个或者更多的洞(未示出)。 In a further alternative embodiment, if desired, with a set of proximal positioning piece 210 adjacent to the collar embodiment 212 may further extend proximally from the positioning piece 210, and the collar will be in one or more hole (not shown). 螺钉、钉子、或其它的固定装置(同样未示出)可以横向插入骨骼和穿过这些洞,以进一步提高装置200的稳定性。 Screws, nails or other fastening means (also not shown) may be inserted transversely through the bone and the holes, to further enhance the stability of device 200. 同样地,除此之外或者替代近端的轴环212上的这些装置,与远端的一组定位片210相邻的轴环212可从定位片210向远端进一步延伸并可包括一个或更多的洞来容纳通过其中的其它固定装置。 Similarly, in addition to these devices or collar 212 on alternative proximal end and a distal end of a set piece 210 positioned adjacent to the collar 212 may extend further from the positioning piece 210 may include one or distally more holes to accommodate other securing devices therethrough.

在骨折愈合后,装置200可以通过入口130取出。 After healing, the device 200 can be removed through the inlet 130. 入口130会被新生骨骼(未示出)所覆盖,并可以通过一个小的皮肤切口露出。 Entrance 130 will be new bone (not shown) covered and can be a small skin incision exposed. 任选地,装置200可以包括一个从近端端部204延伸的指示元件(未示出)。 Optionally, apparatus 200 may include an indicating element 204 extends from the proximal end (not shown). 如果是这样,该指示元件可以突出或者嵌入新生骨骼的表面。 If so, the indicating element may be protruding or embedded in the surface of the new bone. 将指示元件周围的新生骨骼去除,暴露出入口130。 Indicating new bone around the components removed, exposing the entrance 130. 一旦确定位置,装置200将通过朝与膨胀定位片元件210相反的方向转动致动轴环来折叠。 Once the location of the device 200 toward the expansion by positioning piece element 210 in the opposite direction to the rotation of the actuation collar fold. 然后,装置200可从髓管118中抽出,使入口130和覆盖组织得以痊愈。 Then, the device 200 can be withdrawn from the medullary canal 118, the inlet 130 and cover organizations to heal.

可选地,装置200可以全部或部分地由一种可被生物体完全吸收的材料构成,这样,在一些病例中,无需为取出装置200进行二次手术,或者仅仅是该装置200的一部分需要取出。 Alternatively, apparatus 200 may all be formed of a partially or organism may be constructed entirely absorbable material, so that in some cases, no need to take out a second operation unit 200, or just a part of the apparatus 200 need take out.

参见图7和图8,示出髓内装置300的第二实施例,其包括一个管轴302、近端与远端端部304、306,该两个末端之间限定了一纵轴308。 Referring to Figures 7 and 8, there is shown a second embodiment of the intramedullary device 300, which comprises a shaft tube 302, proximal and distal ends 304,306 defining a longitudinal axis 308 between the two ends. 管轴302是一个普通的管状体,例如,有一个与上述装置200的管轴210相似的圆形或其它形状的横截面。 Tube axis 302 is an ordinary tubular body, for example, there is a tube axis 210 of the apparatus 200 is similar to the circular cross-section or other shapes.

如图所示,多个定位片310从管轴302的近端端部304延伸,最好是从管轴302的近端端部304和远端端部306都延伸出来。 As shown, a plurality of positioning pieces 310 from the proximal end of the tube shaft 304 extends 302, preferably from the proximal end of the tube shaft 304 and the distal end 302 of the 306 are extending. 定位片310在通常的轴向折叠状态(如图7A和8A中所示)和完全横向膨胀状态(如图7B和8B所示)之间膨胀。 Positioning piece 310 is generally axial collapsed state (as shown in FIG. 7A and 8A) and a fully expanded transverse expanded state (FIG. 7B and 8B) between. 定位片310可以是完全扁平的条带、细丝或其它能呈现出折叠和膨胀状态的结构。 Orientation film 310 may be completely flat strip, other filaments can exhibit the structure collapsed and expanded state or.

参见图7A和7B所示,每一个定位片310都包括一个与管轴302相连接的第一末端区310a,和一个进入到管轴302第一末端区310a的第二末端区310b。 7A and 7B, each positioning piece 310 includes a first end region 302 connected to the tube axis 310a, and an axis of the tube 302 into the first end region of the second end region 310a 310b. 定位片310的第二末端区310b与管轴302内的一个致动器相连接。 Positioning a second end region 310 of the sheet 310b with an actuator 302 is connected to the inner tube axis. 定位片310的第一末端区310a与管轴302通过诸如枢接结构(未示出)相连接,或者类似于前述实施例,与管轴302整体构成。 Positioning the first end region 310 of the sheet 310a is connected to the tube shaft 302 through a pivot structure such as a (not shown), or similar to the foregoing embodiment, the tube shaft 302 integrally constituted.

每一个定位片310还包括有一个中间区或弯折区310c,弯折区310c可以相对纵轴308充分地横向向外伸展,以限定膨胀状态。 Each positioning piece 310 further comprises an intermediate zone or bent zone 310c, 310c can be folded region transversely relative to the longitudinal axis 308 extending outwardly sufficiently, to define the expanded state. 参见图8A所示,在折叠状态中,定位片310的第一和第二末端区310a、310b通常相互毗连排列,并且充分平行于纵轴308延伸,例如,中间区310c通常和管轴302的横截面是同延的。 Referring to Figure 8A, in the folded state, a first orientation film 310 and the second end region 310a, 310b are arranged adjacent to each other generally, and extending substantially parallel to the longitudinal axis 308, e.g., an intermediate region 310c of the shaft 302 and the tube generally the cross-section is coextensive. 参见图8B所示,在膨胀状态下,定位片310的中间区310c充分向外横向移动。 See Fig. 8B, in the expanded state, the intermediate region 310 of the positioning piece 310c sufficiently to move laterally outwardly. 因此,在膨胀状态中,定位片310限定了一个完全大于管轴302直径的直径。 Thus, in the expanded state, the positioning piece 310 defines a diameter greater than the tube shaft 302 completely diameter.

为了控制定位片310的膨胀和折叠,一般在管轴302中放置一个致动器(未示出)。 In order to control the orientation film 310 is expanded and folded, generally placed in the tube axis 302 an actuator (not shown). 在一个优选的实施例中,制动器可以包括一个与第二末端区310b相连接的可在管轴302中移动的轴环(未示出)。 In a preferred embodiment, the brake may include a movable collar 302 of the tube axis and a second end region 310b is connected (not shown). 该轴环可在管轴302中可控制地轴向移动,例如,与前面所述相类似地采用一个带螺纹的轴环和/或杆装置。 The collar 302 in the tube axis can be controlled to move axially, e.g., similarly to the previously described using a threaded collar and / or the rod means. 这样,致动器连接到定位片310上,以在折叠和膨胀状态间选择性地膨胀定位片310。 Thus, the actuator is connected to the positioning piece 310 to an expanded state between the folded and selective expansion of the positioning piece 310.

在一个实施例中,定位片310偏置于呈现其膨胀状态,且轴环可以轴向移动,例如,远离定位片310,以拉动第二末端区310b,并折叠定位片310至它们的折叠状态。 In one embodiment, the positioning piece 310 biased to assume its expanded state, and the collar can be moved axially, e.g., away from the positioning piece 310, to pull the second end regions 310b, and the positioning piece 310 is folded to their collapsed condition . 当轴环在反方向轴向移动时,即朝向定位片310移动,定位片310可以自由膨胀至膨胀状态。 When the collar is axially moved in the opposite direction, that is, moving toward the positioning piece 310, the positioning piece 310 is free to expand to the expanded state.

与前面所述的实施例相似,在使用过程中,装置300可以用于骨折骨骼(未示出)的髓管中。 Previously described embodiment is similar during use, the apparatus 300 can be used for a fractured bone (not shown) in the medullary canal. 在定位片310折叠时,装置300可以通过预先形成的入口插入到髓管中。 When positioning the folded sheet 310, the apparatus 300 can be inserted into the medullary canal through the inlet formed in advance. 一旦装置300完全插入到髓管中,一个工具(未示出)可通过入口被导入到管轴302中,接合并驱动装置300中的致动器,也即在近端端部304将定位片310膨胀至其膨胀状态。 Once the device 300 is fully inserted into the medullary canal, a tool (not shown) may be introduced through the inlet to the tube shaft 302, engages the drive means of the actuator 300, i.e. at the proximal end of the positioning piece 304 310 expanded to its expanded state. 膨胀的定位片310有足够的柔韧性和/或弹性以与近端的干骺端区相适应,和/或借助多个接触点充分紧密地与近端干骺端区的骨壁相接合。 Expanded orientation film 310 has sufficient flexibility and / or resiliency to the proximal metaphyseal region to adapt, and / or by a plurality of contact points sufficiently closely to the wall of the proximal metaphyseal region of the bone engagement.

在一个实施例中,当近端端部304的定位片310膨胀时,远端端部306上的定位片310同时膨胀。 In one embodiment, when the positioning piece proximal end 304 310 expansion, positioning the distal end portion of sheet 310 306, while expansion. 可选地,远端端部306上的定位片310可以通过一个单独的制动器独立地膨胀,例如,用一个与所述的远端端部304类似的工具和方法。 Alternatively, the distal end portion of the positioning piece 306 310 can be independently expanded by a separate brake, for example, with the distal end of one of the 304 similar tools and methods. 在一个进一步可选的实施例中,髓内装置可以是仅包括单独一组的定位片,与图10A-11B中所示的实施例相似。 In a further alternative embodiment, the intramedullary device may include only a single set of positioning sheet, similar to the embodiment shown in FIG. 10A-11B.

在骨折愈合后,类似于前述实施例,可以取出装置300。 After fracture healing, similar to the previous embodiment, the apparatus 300 can be removed. 在取出过程中,与膨胀定位片310的方法相似,通常将一个工具引入管轴302中以接合致动器来折叠定位片310。 In the removal process, and method of expansion positioning piece 310 is similar, usually a tool to introduce the tube axis 302 to engage the actuator to fold the orientation film 310. 在一个进一步可选的实施例中,类似于前述实施例,装置300可以包括一个指示元件(未示出)用于帮助取出装置300,和/或装置300至少是部分地由一种生物完全吸收材料构成。 In a further alternative embodiment, similar to the previous embodiment, the apparatus 300 may comprise an indicating element (not shown) is used to help remove the device 300, and / or device 300 is at least partially absorbed by an organism entirely material.

参见图9A和9B,示出另一种髓内装置400的实施例,同以上所述的实施例相似,该装置包括一个管轴402、和近端端部404及远端端部406,该两个末端之间限定了一条纵轴408。 Referring to FIG. 9A and 9B, showing another embodiment of the intramedullary device 400, with similar to the embodiment described above, the apparatus comprising a tube shaft 402, and a proximal end 404 and a distal end portion 406, the defining a longitudinal axis 408 between the two ends. 如图所示,多个定位片410从管轴402的近端端部404伸出,最好是从管轴的近端端部404及远端端部406都延伸出来。 As shown, a plurality of positioning pieces 410 from the proximal end 404 of the tube shaft 402 extends, preferably from a distal end 404 and the proximal end of the tube shaft 406 are extending. 定位片410在通常的轴向折叠状态(未示出)和完全横向膨胀状态(如图9B所示)之间膨胀。 410 in the conventional axial expansion between the folded state (not shown) and completely laterally expanded state (FIG. 9B) positioning piece. 定位片410可以是完全扁平的条带、细丝、或其它具有一个连接到管轴402上的第一末端410a和一个自由末端410b的结构。 Orientation film 410 may be completely flat strip, filaments, or other having a first end connected to the tube axis 410a 402 and on a free end 410b of the structure. 更佳地,定位片410偏向于呈现其膨胀状态,但是定位片410可被其上的套筒412约束在折叠状态,其操作与上述的可移动的轴环相似。 More preferably, the positioning pieces 410 tend to assume its expanded state, but the sheet 410 may be positioned on the sleeve 412 in the folded state constraint, the operation of said movable collar is similar.

在使用中,装置400可以用于诸如带有复合骨折128的骨折股骨100的髓管118中。 In use, the apparatus 400 can be used, such as complex fractures medullary canal 128 of femur fractures with 100 of 118. 可选地,类似于上述实施例,装置400也可以放入除股骨100以外的其它骨骼中。 Alternatively, similarly to the above embodiments, apparatus 400 may be placed in other bones other than the femur 100 in addition. 如图9A所示,在定位片410折叠时,装置400可以通过预先形成的入口130插入到髓管118中。 9A, when the positioning piece 410 is folded, the apparatus 400 can be inserted into the medullary canal 118 through the inlet 130 formed in advance. 一旦装置400被完全插入到髓管118中,套筒412可轴向引导来露出和释放定位片410。 Once the device 400 is fully inserted into the medullary canal 118, the sleeve 412 may be directed axially to expose and release the positioning piece 410. 更佳地,定位片410向膨胀状态自动膨胀,而且具有足够的柔韧性和/或弹性来与近端的干骺端区域120相适应和/或与近端的干骺端区域120的骨壁牢固接合。 More preferably, the positioning piece 410 is automatically expanded to an expanded state, and has sufficient flexibility and / or elasticity of the proximal metaphyseal region 120 compatible bone wall and / or the proximal metaphyseal region 120 firmly bonded.

在骨折愈合后,类似于上述的实施例,可以取出装置400。 After fracture healing, similar to the embodiment described above, the apparatus 400 can be removed. 在这一取出过程中,类似于膨胀定位片410的方法,引入一个工具来引导套筒412重新套在定位片410上。 In this removal process, a method similar to the expansion orientation film 410, the introduction of a tool to guide sleeve 412 re-sets the orientation film 410. 在一个进一步可选的实施例中,该装置400可以包括一个指示元件(未示出)以帮助取出所述装置400。 In a further alternative embodiment, the apparatus 400 may comprise an indicator element (not shown) to assist in removing the device 400.

在此所述的任一装置至少是部分地包括一种生物可吸收材料,一种形状记忆合金或聚合物,如镍钛合金,或其它弹性材料如不锈钢或钛合金等。 Means herein any of said at least partially comprises a bioabsorbable material, a shape memory alloy or polymer, such as Nitinol, or other resilient material such as stainless steel or titanium alloy. 此外,类似于图10A至11B所示的实施例,髓内装置可以包括单独一组定位片,这些定位片可用于稳定骨折,例如,在诸如股骨或肱骨的骨颈或其它末端之中或者与之邻近的骨折,或者在髋骨中的骨折。 Further, the embodiment, as shown in the intramedullary device 10A to 11B similar to Figure may include a separate set of positioning sheet, which can be used to stabilize the fracture orientation film, for example, in the neck or other bone such as the femur or humerus terminal among or with The adjacent fractures, or fractures in the hip.

参见图12-14B,示出根据本发明的另一个优选实施例的髓内装置500。 Referring to Figure 12-14B, intramedullary device 500 is shown according to another preferred embodiment of the present invention. 通常,装置500包括一个管轴502,一个或多个轴环512,和一个细长控制件522。 Generally, the apparatus 500 includes a tube axis 502, one or more collars 512, and an elongate control member 522. 管轴502包括近端端部504和远端端部506,该两个末端之间限定了一条纵轴508。 Tube shaft 502 includes a proximal end and a distal end 504 506 508 defines a longitudinal axis between the two ends. 管轴502是一个普通的管状体,例如,具有一个环形的或其它形状的横截面(例如,椭圆形、正方形、凹槽形等等),并且限定了一个在近端端部504与远端端部506之间延伸的管腔507。 Tube axis 502 is an ordinary tubular body, for example, or having an annular cross section (e.g., oval, square, fluted, etc.) other shape, and defines a proximal end 504 and the distal end a lumen extending between the ends 506 507. 管体508可以有一个实心管壁,或者举例来说,为了促进该处流体从中流动,为了把重量降至最小,为了提供期望的柔韧性,和/或为了允许管轴502膨胀,在其上设有栅格或是其它样式的洞(未示出)。 The tube 508 may have a solid wall, or for example, where in order to promote the flow of fluid therethrough, in order to minimize weight, in order to provide the desired flexibility, and / or 502 in order to allow expansion of the tube axis, on which with a grid or other pattern holes (not shown). 在一个可选的实施例中,管轴502可以包括有多个轴向刺片构件,这些刺片构件通过一个网件或者其它相互连接的结构互相连接,如序列号为No.09/426,563的申请中所描述,可将其结合进以上内容供参考。 In an alternative embodiment, the axis of the tube 502 may include a plurality of axial spines sheet member, the sheet member through a stab or other network interconnecting member interconnecting structure, such as Serial No. No.09 / 426,563 of as described in the application, it may be incorporated into the above reference.

如图所示,多个定位片510从管轴502的近端端部504延伸出,最好是从管轴的近端端部504及远端端部506都延伸出来。 As shown, a plurality of positioning pieces 510 from the proximal end of the tube shaft 504 extends 502, preferably from the proximal end 504 and distal end 506 are extended from the tube axis. 为了在通常的轴向折叠状态(如图13A和14A中所示)和完全横向膨胀状态(如图13B和14B所示)之间膨胀定位片510,多个支撑臂520连接到定位片510上。 In order to generally axial collapsed state (shown in FIG. 13A and 14A) and completely laterally expanded state (shown in FIG. 13B and 14B) expanded orientation film 510, a plurality of support arms 520 connected to the positioning piece 510 . 最好是,如同下面进一步解释的,定位片510和支撑臂520由一个单独的条带状材料形成。 Preferably, as explained further below, the positioning piece 510 and support arm 520 by a separate strip material. 可选地,它们可以是单独的构件,通过诸如焊接、粘结、粘附和其它类似的方法相互连接。 Alternatively, they may be separate members, and the like by methods such as welding, bonding, adhering to each other. 进一步可选择地,定位片510和/或支撑臂520可以是完全圆形的线、细丝、或其它可以呈现折叠与膨胀状态的结构。 Further alternatively, the positioning pieces 510 and / or support arm 520 may be completely circular lines, filaments, or other expanded state may be presented with a folded configuration.

参见图13A-14B所示,每个定位片510包括一个与管轴502相连接的第一末端区510a和远离管轴502的第二自由末端区510c。 Referring to FIG. 13A-14B, the first end region of each orientation film 510 includes a shaft 502 connected to the tube 510a and 502 away from the tube axis of the second free end zone 510c. 最好是,第二末端区510c在折叠状态下处于基本上轴向远离管轴502的位置。 Preferably, the second end region 510c in the folded state is located substantially axially away from the shaft 502 of the tube. 各个支撑臂520均包括一个与轴环512相连接的第一末端520a和一个与相应的定位片510相连接的第二末端520c。 Each support arm 520 includes a first end 520a of the collar 512 and a second end connected to 520c with a respective positioning piece 510 is connected. 虽然可选择地,支撑臂520的第二末端可以连接到定位片510的中间区510b(未示出),但最好是,支撑臂520的第二末端520c连接到定位片510的自由末端区510c。 Although Alternatively, support arm second end 520 may be connected to the intermediate section 510 of the positioning piece 510b (not shown), but preferably, the second end of the support arm 520c 520 is connected to the free end of the positioning piece 510 Zone 510c.

更佳地,所述定位片510的第一末端区510a与管轴502是整体构成的,同时支撑臂520的第二末端520c与相应的定位片510的第一末端区510a也是整体构成的。 More preferably, the positioning piece 510 with a first end region 510a to the tube axis 502 is integrally formed, while the second end of the support arm 520 of the respective positioning piece 520c and the first end 510 of the zone 510a is integrally formed. 定位片510和支撑臂520的中间区510b、520b有充分的柔韧性来弯曲,以满足在折叠状态和膨胀状态之间的运动需要,如同下面进一步所解释的。 Positioning pieces 510 and the intermediate region 520 of support arm 510b, 520b has sufficient flexibility to bend to meet the need for movement between the collapsed state and the expanded state, as explained further below. 例如,管轴502、定位片510、和支撑臂520由一单节管材切除适当材料所形成,如同下面进一步所解释的。 For example, the tube shaft 502, a positioning piece 510, and the support arm 520 by a single cut tube formed of a suitable material, as explained further below. 可选地,定位片510的第一末端区510a可以是通过诸如焊接、枢接、或是销钉(未示出)连接到管轴502的独立条带,和/或支撑臂520的第二末端520c可通过焊接、枢接、或是销钉(未示出)连接到定位片510的第二末端区510c。 Alternatively, positioning the first end region 510 of sheet 510a may be connected to the tube axis by 502 independent bands such as welding, pivoting, or pin (not shown), and / or support arm second end 520 520c by welding, pivot or pin (not shown) connected to the positioning piece 510 of the second end region 510c.

参见图14A和14B,控制件522可以是一个具有近端端部524和远端端部526的实心杆或者管状构件。 Referring to Figure 14A and 14B, the control member 522 may be a portion 524 having a proximal end and a distal end portion of the tubular member or a solid rod 526. 控制件522具有能使其容纳在管轴502的管腔507中的直径或者其它横截面。 Control member 522 has enable it to accommodate the tube axis 507 502 lumen diameter or other cross-section. 更可取的是,如图所示,控制件522包括有一个或者更多的螺纹区,诸如近端螺纹区528a、中间螺纹区528b和远端螺纹区528c。 More preferably, as shown, the control member 522 includes one or more threaded area, such as a proximal threaded region 528a, intermediate threaded region 528b, and distal threaded region 528c. 尤为可取地,近端螺纹区528a和远端螺纹区528c有着旋向互相相反的螺纹,这将在后面进一步解释。 Especially Preferably, the proximal and distal threaded region 528a has a screw threaded region 528c opposite to each other threads, which will be explained further below.

管轴502可以包括有一个位于管腔507中的内部环形区530,环形区限定了一个内表面532,其具有和杆522的中间螺纹区528b相似的螺纹。 The tube 502 may include a shaft lumen 507 is located in the inner annular region 530, the annular region defining an inner surface 532, and a rod 522 having an intermediate threaded region 528b similar thread. 最好是环形区530与控制件522具有相同的直径,从而除了在杆522绕着轴508旋转时,内表面532上的螺纹可以与中间螺纹区528b啮合以防止杆522的轴向移动。 Preferably the control member 530 and the annular region 522 have the same diameter, so that in addition to the lever 522 about the shaft 508 rotates, the threaded inner surface 532 may be engaged with the intermediate threaded region 528b to prevent axial movement of the rod 522. 环形部分530可以从管轴502中加工出,或者是一个环形套,该套被插入到管腔507中并通过诸如焊接、粘结或是其它类似方法,固定在中间区。 Annular portion 530 can be machined from the tube axis 502, or an annular sleeve, the sleeve is inserted into and through the lumen 507 such as welding, bonding or other similar methods, it is fixed in the intermediate region.

类似地,轴环512也有带螺纹的内表面与控制件522的近端和远端螺纹区528a、528c相啮合。 Similarly, the collar 512 also has an inner surface of a threaded proximal end and a distal end and control threaded area 522 528a, 528c meshed. 更好地,为了分别与近端螺纹区528a和远端螺纹区528c配合,近端的轴环512a有一个与远端轴环512b旋向相反的内螺纹。 Better, in order to, respectively, the proximal and distal threaded region 528a threaded region 528c with the proximal end of the collar 512a has a distal collar 512b rotating in the opposite internal thread. 此外,轴环512有一个外径,使得轴环512在管轴502的近端端部504和远端端部506处滑移入管腔507中。 In addition, the collar 512 has an outer diameter, so that the collar 512 at the proximal end of the tube axis and a distal end 504 506 502 507 slip into the lumen. 如下文进一步所阐述,轴环512可以包括用于容纳支撑臂520的第一末端520a的狭槽或者凹穴(未示出)。 As further set forth, the collar 512 may include a support arm 520 for receiving a first end 520a of the slot or recess (not shown).

参见图15A-15D,示出一种将定位片510和支撑臂520作为管轴502的整体件进行制作的优选方法。 Referring to FIG. 15A-15D, shows a positioning piece 510 and support arm 520 as a whole tube axis 502 will be the preferred method of making the. 如同这里所描述的,尽管只示出了一个末端,如果需要,可以理解定位片510和支撑臂520可以在两个末端形成。 As described herein, even though only one terminal is shown, if desired, it is appreciated that the positioning pieces 510 and the support arm 520 may be formed at both ends. 此外,应该指出的是制造管轴502步骤的顺序并不重要,可以接任意顺序完成。 In addition, the order of manufacturing steps of the tube axis 502 is not critical, can then be completed in any order indicated.

首先,如图15A所示,提供一个细长管600,最好是具有圆柱(或其它)外形的细长管,定位片将其切到与最终的管轴502和位于管轴502的一个末端(或两末端)的定位片510结合长度相符的长度(未示出)。 First, as shown in FIG. 15A, there is provided an elongated tube 600, preferably having a cylindrical (or other) shape of the elongated tube, positioning a sheet to be cut to the final end of the shaft 502 and the tube 502 is located in the tube axis (or both ends) of the positioning piece 510 matches the combined length of the length (not shown). 该管子由各种具有足够的结构整体性的生物相容材料构成,优先选用不锈钢或钛。 The tube made of sufficient structural integrity of various biocompatible materials, preferred stainless steel or titanium. 如图15B所示,第一狭槽602可以构造在管子600的末端604中,它平行于轴606在纵向充分延伸,从而在毗邻的狭槽602之间限定了定位片510。 15B, a first slot 602 may be configured at the end of the tube 604 600, 606 parallel to the axis extending in the longitudinal direction sufficiently so that the slots 602 between adjacent sheet 510 defining the positioning. 第一狭槽602可通过激光切割、机械切割等来形成。 The first slot 602 by laser cutting, mechanical cutting or the like. 如果需要,由第一狭槽602限定的纵向边缘可以是圆的、纵倾的、或作过其它改进的以防止相邻的定位片510在诸如从折叠状态下膨胀或者是收回至折叠状态时互相钩住。 If desired, the longitudinal edges defined by the first slot 602 may be circular, trim, or made other modifications to prevent adjacent positioning piece 510, such as during the expansion from the collapsed state to the collapsed or retracted state hook each other.

再看图15C,多对第二狭槽608在相邻的第一狭槽602之间制出,它平行于轴606充分延伸,但不完全延伸至管子600的末端601。 Referring again to Figure 15C, pairs of second slots 608 between adjacent first slots 602 made out, it fully extends parallel to the axis 606, but not fully extend to the end of the tube 601 600. 第二狭槽608的末端可以与圆周方向狭槽610连接,从而限定支撑臂520。 End of the second slot 608 of slot 610 can be connected to the circumferential direction, thereby defining a support arm 520. 因此,每一个定位片510都由一对窄杆511限定,窄杆在对应的支撑臂520两侧从管轴502延伸,并在自由末端510c终止。 Thus, each sheet 510 by a pair of positioning rods 511 defining narrow, narrow bar 520 on both sides of the respective support arm 502 extending from the tube axis, and terminates at the free end 510c. 如图所示,支撑臂520可以比定位片510更长,相对于定位片510可以提供更大的柔韧性,或者可选地,支撑臂520通常与定位片510一样长或者较短。 As shown, the support arm 520 may be longer than the positioning pieces 510, 510 relative to the positioning sheet can provide greater flexibility, or alternatively, the support arm 520 is generally the same length and the positioning piece 510 or shorter. 如该本领域中技术人员所熟知的,定位片510和支撑臂520的相对宽度和长度很容易被确定,以提供一个期望的折叠和膨胀程度,并且能够轻松折叠和膨胀。 As those skilled in the art known, positioning pieces 510 and the support arm 520 relative width and length can be easily determined to provide a desired degree of folding and expansion, and can be easily folded and expanded.

可选地,如图15D所示,定位片510的自由末端510c被加工来产生啮合元件的组织,例如带凹口的尖头513。 Alternatively, as shown in FIG. 15D, the free end 510 of the positioning piece 510c is processed to produce tissue engaging member, e.g., notched tip 513. 可选地或另外地,自由末端510c可以被折弯或弯曲,例如放射状向外(未示出),以在植入过程中加强与骨骼或其它组织的结合。 Alternatively or additionally, the free ends 510c may be bent or curved, e.g., radially outward (not shown), to enhance the process of implantation in combination with bone or other tissue. 此外,一个或者更多的槽口612在每一个支撑臂520的第一末端520a中形成,来限定用于把支撑臂520固定到轴环512(未示出)的接头614。 In addition, one or more slots 612 in each of the first support arm 520a 520 formed in the end, to define for the support arm 520 is fixed to the collar 512 (not shown) of the connector 614. 在一个进一步可选的实施例中,该定位片510和支撑臂520在单独的管套上形成,该管套通过诸如焊接、摩擦配合、螺纹啮合、粘合等等,连接到管轴的一个或者两个末端(未示出)。 In a further alternative embodiment, the positioning pieces 510 and the support arm 520 is formed in a separate sleeve tube, the tube sleeve, such as by welding, friction fit, threaded engagement, adhesive, etc., is connected to a tube axis or both ends (not shown).

回到图14A和14B,一旦定位片510和支撑臂520形成在或连接在管轴502的一个或者两个末端504、506上,轴环512可以被插入到管腔507中,并且支撑臂520的第一末端520a可以连接到对应的轴环512。 Returning to Figure 14A and 14B, once the positioning piece 510 and the support arm 520 is formed on or attached to the tube shaft 502 on one or both ends 504, 506, the collar 512 may be inserted into the lumen 507, and support arms 520 The first end 520a may be connected to a corresponding collar 512. 该轴环512可以包括狭槽或凹部(未示出)以容纳相应的支撑臂520的接头614。 The collar 512 may include a slot or recess (not shown) to receive a respective support arm 520 of connector 614. 此外或可选地,该支撑臂520的第一末端520a可以粘合或焊接在轴环512上。 Additionally or alternatively, the support arm first end 520a 520 may be glued or welded to the collar 512.

更佳地,轴环512可以拧到控制件522上并进入管轴502中。 More preferably, the collar 512 can be screwed onto the control member 522 and into the tube axis 502. 控制件522可以插入到管轴502的管腔507中,并穿过环形区530螺接直到其近端端部524和远端端部526布置在管轴502的近端端部504和远端端部506中。 The control member 522 may be inserted into the lumen of the tube shaft 507 502, and through the annular region 530 is screwed until its proximal end 524 and distal end portion 526 is disposed in the tube axis 502 of the proximal end 504 and a distal end ends 506. 轴环512可以拧到近端端部524(和/或远端端部526)上,直到轴环512进入管腔507且与支撑臂520的第一末端520a贴近布置。 The collar 512 can be screwed to the proximal end 524 (and / or distal end portion 526), and until the collar 512 into the lumen 507 and the first end of the support arm 520a 520 the close arrangement. 如上所述,将支撑臂520连接到轴环512。 As described above, the support arm 520 is connected to the collar 512.

起初,该装置500的定位片510处于其折叠状态,如图13A所示。 Initially, the positioning means 500 of the sheet 510 in its folded state, shown in Figure 13A. 在折叠状态下,定位片510和支撑臂520互相邻接放置以至于它们完全沿纵轴508平行伸展。 In the folded state, the orientation film 510 and the support arm 520 is placed adjacent to each other so that they are fully parallel extending along a longitudinal axis 508. 为了膨胀定位片510,可用一个工具(未示出)来使控制件522向预定方向旋转。 To locate the expansion piece 510, can be used a tool (not shown) of the control member 522 is rotated in the predetermined direction. 例如,如图14A和14B所示,可以提供一个槽534或其它带有键的元件,诸如一个从控制元件522延伸出的凸耳(未示出),来与该工具相接合。 For example, as shown in FIG. 14A and 14B, a groove 534 may be provided with keys or other elements, such as one from the control member 522 extending lugs (not shown), to close contact with the tool. 由于近端螺纹区528a和远端螺纹区528c上的螺纹旋向相反,随着控制元件522的旋转两个轴环512都从管腔507中向外移动。 Since the threaded proximal threaded region 528a and a distal threaded region 528c on the contrary, as the controlling rotating element 522 are two of the collar 512 to move outward from the lumen 507. 换句话说,近端轴环512a向近端移动,而远端轴环512b向远端移动。 In other words, the proximal end of the collar 512a move proximally, while the distal collar 512b moves distally.

轴环512的这种移动引起支撑臂520的第一末端520a向外轴向移动(即靠近位于近端端部504上的支撑臂520)。 This movement of the collar 512 to cause the support arm 520 of the first end 520a axially outward movement (ie, located near the proximal end of the support arm 520 504). 因此,如果在管轴502的近端端部504和远端端部506上都设有定位片510,近端和远端支撑臂520的第一末端520a将彼此远离。 Therefore, if the proximal end 504 and a distal end 506 of the tube shaft 502 are provided with a positioning piece 510, a proximal end and a distal end of the support arm 520 away from each other to a first end 520a. 由于支撑臂520的第二末端520c与定位片510相连接,这将引起支撑臂520的中间区520b弯折并控制定位片510径向向外,直到定位片510相对纵向轴508充分朝向横向以限定该膨胀状态,如图12所示。 Since the support arm 520c and a second end connected to the positioning piece 510 520, which will cause the intermediate section 520 of the supporting arm 520b bend and control the positioning pieces 510 radially outward until relative to the longitudinal axis positioning pieces 510 508 fully toward transverse direction define the expanded state, as shown in Figure 12.

在骨骼中使用该装置500来治疗骨折与上述实施例相似。 The apparatus used in treating bone fractures 500 similar to the above-described embodiment. 如图13A所示,装置500可通过一个预先形成的入口插入到骨骼的髓管中,例如定位片在股骨(未示出)中带有折叠的定位片510。 13A, the inlet means 500 through a preformed tube is inserted into the bone marrow, for example in a femoral positioning piece (not shown) with the positioning piece 510 is folded. 最好是,首先,采用传统方法通过入口将一根引线或其它元件(未示出)插入到骨骼的髓管中并延伸至远端骨段。 Preferably, the first inlet by a conventional method by a lead or other elements (not shown) inserted into the medullary canal of the bone and extends to the distal bone segment. 接着,将该装置500沿着引线移进到髓管中,例如,通过插入引线穿过控制元件522中的内腔。 Subsequently, the device 500 is moved into the lead along the medullary canal, for example, by inserting a lead through the lumen of the control member 522. 在插入装置500后,可再将引线取出。 After inserting the device 500, may then lead removed.

如图13B所示,一旦装置500完全插入进髓管中,就可通过旋转控制元件522,使定位片510膨胀至该膨胀状态。 As shown in Figure 13B, once the device 500 is fully inserted into the medullary canal, can be controlled by rotating the element 522, the positioning piece 510 is expanded to the expanded state. 最好是,定位片510膨胀后能充分与内骨骼或其它组织接合,从而使得装置500相对于骨骼充分固定。 Preferably, to fully engage with the inner bone or other tissue swelling after positioning pieces 510, so that the device 500 relative to the bone fully fixed. 因此,装置500能防止那些内部植入有装置500的骨片彼此间轴向移动、弯折、和/或旋转。 Accordingly, the apparatus 500 can be prevented that the internal bone fragments implanted device 500 to each other to move axially, bending, and / or rotation. 可选地,如果需要额外的稳定性,可用一个近端延伸部分(未示出)向近端方向延伸到近端端部504上的定位片510之外。 Alternatively, if additional stability, it can be used a proximal extension (not shown) extending proximally beyond the proximal end of the positioning piece 510 504. 例如,管轴502可以包括有一个轴向延伸部分(未示出),这个轴向延伸部分向近端方向延伸到超出定位片510(可能需要去除定位片510中的一个或多个定位片以容纳该延伸部分),或者可选地,控制元件522可以向近端方向延伸至超出定位片510。 For example, the tube 502 may include a shaft axially extending portion (not shown), the axially extending portion extends beyond the proximal direction positioning piece 510 (which may require removal of the positioning piece 510 with one or more positioning pieces receiving the extension), or alternatively, the control element 522 may extend beyond the proximal direction to the positioning piece 510. 多个孔眼(未示出)穿过近端延伸部分,并且螺钉、钉子、或其它固定装置通过这些洞插入,例如横向穿过骨骼和近端延伸部分,以进一步保护骨骼段。 A plurality of perforations (not shown) extending through the proximal end portion, and screws, nails or other fixing means inserted through these holes, e.g., transversely through the bone and a proximal portion extending to further protect the bone segment.

控制元件522上带有螺纹的一个优点就是它能使装置500的一个末端上的定位片510比另外一端上的定位片510膨胀到一个更大的尺寸。 Threaded advantage is that it enables the control element positioning pieces 510 522 500 on one end than the other end positioning piece 510 on expansion to a larger size. 与其仅仅旋转控制元件522使定位片510的每一组膨胀至彼此完全相等,不如在控制元件522上施加一个轴向力,使得控制元件522轴向移动穿过管轴502。 Only its rotation control element 522 so that the positioning of the expanded sheet 510 to each set completely equal to each other, as to exert an axial force on the control member 522, so that the control member 522 to move axially through the tube shaft 502. 由此,使一个轴环512完全保持固定,而另一个轴环512更进一步向外移动,而不是使轴环512都相对管轴502移动。 Thus, to make a collar 512 completely remains fixed, while the other collar 512 to move further outward, instead of making the collar 512 are moved relative to the tube shaft 502.

当骨折愈合后,就可取出装置500,类似于上述的实施例。 After healing, you can remove the device 500, similar to the embodiments described above. 在该取出过程中,可引入一个工具来控制定位片510返回折叠状态,这与膨胀定位片510的方法相似。 In the removal process, it can introduce a tool to control the positioning pieces 510 return folded, similar to the method of expansion of the positioning piece 510. 在一个进一步可选的实施例中,该装置500可以包括一个指示物元件(未示出)以便于固定和/或取出装置500。 In a further alternative embodiment, the apparatus 500 may comprise a indicator element (not shown) so that the fixed and / or removing means 500.

回到图16,图中示出了一个髓内装置700的一个可选实施例,该装置包括一第一组定位片710,它位于管轴702的一个末端704上,与前面所述的实施例相似。 Returning to Figure 16, there is shown an intramedullary device 700 an alternative embodiment, the apparatus comprises a first set of positioning pieces 710, 704 which is located on one end of the tube shaft 702, with the foregoing embodiments Cases similar. 此外,装置700还包括一第二组定位片740,它位于管轴702的两个末端704和706之间的中间位置。 In addition, the apparatus 700 further includes a second set of positioning piece 740, which is located in the middle of the tube axis of the two ends 702 and 706 704 between. 第二组定位片740包括支撑臂750,定位片和支撑臂都可以直接在管轴702的管壁形成,类似于末端704所形成的结构。 Positioning a second sheet group 740 includes a support arm 750, the positioning plate and the support arm can be directly formed wall tube axis 702, similar to the structure formed by the end 704. 可将一个轴环(未示出)插入到管轴702中,例如,类似于前面的实施例,将轴环拧在一个杆或其它的控制元件(同样未示出)上,直到轴环最接近第二组定位片740。 You can place a collar (not shown) is inserted into the tube axis 702, for example, similar to the previous embodiments, the collar screwed on a rod or other control device (also not shown) until the collar of the most positioned close to the second set of 740 pieces. 然后支撑臂750可以连到该轴环上,从而杆的转动可以使轴环轴向移动,并且与前述实施例相似,使第二组定位片740膨胀。 Then the support arm 750 can be connected to the collar so that rotation of the rod so that the collar can move axially, similar to the foregoing embodiment and Examples, the positioning piece 740 of the second set of expansion. 可选地,在管轴702上可以有多个孔眼(未示出)。 Alternatively, the tube axis 702 may have a plurality of perforations (not shown). 螺钉、钉子、或其它固定装置可通过这些洞插入,例如,横向穿过骨骼和管轴,以进一步固定骨骼段,类似于上述实施例。 Screws, nails or other fixing means can be inserted through these holes, e.g., transversely through the bone and the tube axis, in order to further secure the segments of bone, similar to the above-described embodiments.

尽管图中只示出了一组中间定位片740,但可以理解用类似的方法沿着管轴可以设置任意组的定位片。 Although the figure shows only a set of intermediate positioning pieces 740, but can be understood in a similar way along the tube axis can be set to any group orientation film. 因此,当装置700植入一根长骨时,装置700可以膨胀并沿着骨骼长度在多个位置与骨骼相接合。 Therefore, when a long bone implant device 700, device 700 can be expanded and in multiple locations along the length of the bone and the bone engagement. 此外,尽管在图示中第一组定位片710和第二组定位片740有相同的长度,但可以理解也可以设置不同长度的定位片。 In addition, although in the illustrated orientation film 710 in the first group and a second group positioning piece 740 have the same length, it will be understood that different lengths may be provided positioning piece. 例如,中间组定位片可以做得比末端上的那些定位片短,比如,以使当末端的定位片组在诸如骨骼末端的扩大区域膨胀时,同时使中间组定位片能在骨骼狭窄区域中膨胀。 For example, the intermediate group orientation film can do better than those on the short end of the orientation film, for example, so that when the end of the positioning piece set at the ends of bones, such as the expansion of regional expansion, while the middle group orientation film can bones confined areas expansion.

在一个更进一步的可选实施例中,本发明所述的装置可用作骨髓内初步固定杆假体段的基础。 In a further alternative embodiment, the apparatus of the present invention may be used as the initial bone marrow stem base fixed prosthesis segment. 例如,可将一个转接器(未示出)连接所述装置,比如,一个圆形部件、插口或其它联接元件(未示出)等假体人造关节表面连接到该定位片组近端或远端的管轴上。 For example, an adapter (not shown) of the device, for example, a circular part, a spigot or other coupling element (not shown) surface of an artificial joint prosthesis is connected to the proximal end of the positioning piece group or the distal end of the tube axis. 可选地,假体可以直接固定在该定位片组上。 Alternatively, the prosthesis can be directly fixed to the positioning piece group. 因此,除稳定骨折骨骼之外,该装置还可用于关节置换过程,或者说,不是仅仅稳定骨折骨骼,而是将其用于关节置换过程。 Therefore, in addition to stabilizing fractured bone outside of the device it can be used for joint replacement procedure, or that not only stabilize the fractured bone, but the process will be used for joint replacement.

尽管本发明已经参照附图和优选实施例进行了说明,但显然,对于本领域的技术人员来说,在不背离本发明的精神和范围的前提下,可以对本发明作出各种更改和变化。 Although the present invention has been described with reference to the accompanying drawings and preferred embodiments, it is clear that for the skilled artisan, without departing from the spirit and scope of the invention premise, you can make various modifications and variations of the present invention. 因此,本发明的各种更改、变化由所附的权利要求书及其等同物的内容涵盖。 Accordingly, the present invention various changes, changes by the appended claims and their equivalents covers.

Referenced by
Citing PatentFiling datePublication dateApplicantTitle
CN104665908A *15 May 20143 Jun 2015财团法人金属工业研究发展中心Marrow inner fixing device
CN104665908B *15 May 201412 Apr 2017财团法人金属工业研究发展中心骨髓内固定装置
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Classifications
International ClassificationA61B17/00, A61B17/74, A61B17/78, A61B17/72, A61B17/56, A61B17/58
Cooperative ClassificationA61B17/7266, A61B2017/00867, A61B17/746, A61B17/7291, A61B17/744
European ClassificationA61B17/74D2, A61B17/74D4, A61B17/72E6B
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