JP2003204969A - Medical installation tool - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an installation tool that helps efficiently and effectively arrange an object, an artificial intervertebral disk for example, between adjacent vertebras. <P>SOLUTION: The installation tool 10 has a pair of facing levers 12 and 14 as a main portion. Each of the levers has a proximal handle 12B and a distal handle 12A. A fulcrum means 16 is provided between the two levers to ensure that the tool is correctly operated. The installation tool has a pusher block 18, too. The pusher block is arranged between the two levers and can selectively move between an initial position in which it is located on the distal side of the fulcrum means and a final position in which it is adjacent to the distal end of the lever. The pusher block has a proximal end 96, a distal end 97 and a bore 98. A pusher rod 20 facilitating the movement of the pusher block has a distal end 20A and a proximal handle end 20B extending into the bore of the pusher block. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

DESCRIPTION OF RELATED APPLICATION This application relates to US patent application Ser. No. 09 / 566,514 filed May 8, 2000 (Title of Invention: Medical Inst.
Allation Tool), a continuation-in-part application, the content of which is hereby incorporated by reference.

[0002]

FIELD OF THE INVENTION The present invention relates to tools for inserting prostheses into the body, and more particularly to tools for inserting prostheses, such as artificial discs and cages, into the intervertebral space.

[0003]

2. Description of the Related Art Spinal surgery has many problems because the long-term health and mobility of a patient (movement of the body) are often influenced by the surgeon's skill and accuracy. One form of spinal surgery requires the removal of the natural disc tissue located between adjacent vertebral bodies.
Techniques are known for replacing damaged natural disc tissue with interbody cages or fixation devices, or disc prostheses.

When inserting an article, such as an artificial disc prosthesis, the surgeon is presented with several challenges.
Adjacent vertebral bodies collapse and abut each other once the natural disc tissue is removed. These vertebral bodies need to be separated to a sufficient extent to allow placement of the prosthesis. However, if the vertebral bodies are separated or distracted to a certain extent, additional damage may occur.
Also, the disc prosthesis must be properly positioned between adjacent vertebral bodies. Over- or under-insertion of the prosthesis can result in pain, postural problems and / or mobility or limited freedom of movement.

Dedicated tools have been developed that facilitate the placement of instruments such as disc prostheses between adjacent vertebral bodies of the patient's spinal column. Among the known tools for performing such procedures are spinal distractors and insertion instruments that are separate from each other. It has been found that distracting the vertebral body with a separate tool to insert a disc prosthesis or graft can be cumbersome. In addition, some distractors cause overdistraction of the vertebral bodies when used.

Exemplary devices for attaching prostheses and / or grafts are disclosed in US Pat. Nos. 5,431,658 and 5,505,732. US Pat. No. 5,431,658 discloses a device that facilitates insertion of a bone graft between two adjacent vertebrae. The disclosed tool has two flat tong-like guides that distract the vertebrae, with a screw type inserter pushing the graft between the distracted vertebrae. US Pat. No. 5,505,732 discloses a device and method for inserting a spinal implant. The intervertebral space is distracted first, and then a hollow sleeve with teeth at one end is driven into the vertebra located adjacent to the disc space.
A drill is then passed through the hollow sleeve to remove the disc and bone in preparation for receiving the spinal implant and then insert the spinal implant into the sleeve.

[0007]

[Patent Document 1] US Pat. No. 5,431,658

[Patent Document 2] US Pat. No. 5,505,732

[0008]

Despite existing tools and techniques, objects, such as intervertebral disc prostheses, are properly and comfortably placed between adjacent vertebral bodies while minimizing the risk of further trauma to the patient. There remains a need to provide an instrument that facilitates insertion.

[0009]

SUMMARY OF THE INVENTION The present invention is a prosthesis,
For example, a device is provided to help safely and effectively implant an artificial spinal disc and cage within a patient. The installation tool of the present invention has as a main part a pair of opposed levers, each lever having a proximal handle portion and a distal portion. A fulcrum means is provided between the two levers to allow the correct operation of the tool.
The tool further comprises a pusher block which is arranged between the two levers and which is located at an initial location distal to the fulcrum means and adjacent to the distal end of the lever. It can move selectively to the final location where it is located. The pusher block has a proximal end, a distal end and a bore extending at least partially therethrough. A pusher rod that facilitates movement of the pusher block has a distal end extending into the bore of the pusher block and a proximal handle end.

The pusher rod and / or pusher block are adapted to be coupled to a variety of prosthetic devices. In one embodiment, the bore may comprise a blind bore and the distal end of the pusher rod may mate with the blind bore of the pusher block. Thus, the pusher block may have a distally facing surface with surface features adapted to mate or mate with complementary surface features on the prosthesis. In another embodiment, the bore may extend completely through the pusher block so that the distal end of the pusher rod can pass through the bore of the pusher block. Thus, the pusher rod may have a distal tip that can be coupled to the prosthesis.

In yet another embodiment, the pusher rod may have a first male threaded distal portion and a second male threaded distal portion. The second distal portion is located proximal to the first distal portion and has a diameter greater than the diameter of the first distal portion. The pusher block bore may have a threaded proximal opening, a distal opening and a chamber formed therebetween. The proximal opening is threaded with the second distal portion of the pusher rod so that the second proximal portion of the pusher rod can be threaded into the proximal opening and positioned within the chamber. The diameter of the pusher block distal opening is less than the diameter of the pusher block proximal opening to prevent the second threaded portion of the pusher rod from penetrating the pusher block distal opening. is necessary. The threaded second distal portion is preferably free to rotate within the chamber of the pusher block. The threaded first distal portion of the pusher rod has a distal tip that extends through the distal opening of the pusher block and is adapted to be coupled to a prosthesis.

In another feature of the invention, the bore extends completely through the pusher block, with the distal tip of the pusher rod extending through the bore of the pusher block. The distal tip of the pusher rod is further adapted to couple to a grasping element releasably engageable with the prosthesis. The grasping element may have an elongated proximal portion having a bore and a distal portion releasably engageable with the prosthesis. The proximal portion has an outer circumference adapted to fit into a bore at the distal end of the pusher block. The distal portion of the grasping element may have opposing first and second parts movable between a first open position and a second closed position capable of engaging the prosthesis. In use, the distal end of the pusher rod is screwed into the bore of the gripping element. When the pusher rod is rotated in the first direction, the elongated proximal portion of the gripping element moves proximally within the bore of the pusher block to move the first and second parts.
Is adapted to be moved to the second closed position. When the pusher rod is rotated in a second, opposite direction, the elongated proximal portion of the grasping element moves distally out of the bore of the pusher block to first open the first and second parts. It is designed to be moved to a position. First part and second
The component of may have at least one surface feature engageable with the prosthesis, but this is optional.

In yet another embodiment, there is a pair of opposed levers, fulcrum means provided between the levers to allow pivoting movement of the levers, and a plurality of prosthesis mounting assemblies. A medical device mounting kit is provided. Each prosthesis mounting assembly is slidably mounted between the levers and is movable between a first proximal position and a second distal position.
Each prosthesis mounting assembly may be provided with a handle portion that allows the prosthesis mounting assembly to move between a first proximal position and a second distal position. Each prosthesis attachment assembly further includes a distal prosthesis handling element adapted to position the prosthesis between adjacent bone tissues.

In one embodiment, one of the prosthesis mounting assemblies is slidably provided between a pusher block having a proximal end, a proximal end and a bore extending therethrough and a lever. And has a pusher rod extending through the bore of the pusher block and a gripping element releasably engageable with the prosthesis. In another embodiment, one of the prosthesis attachment assemblies comprises a pusher rod with a proximal handle portion and a distal portion having a distal tip adapted to securely engage the prosthesis. ing. A pusher block may be provided having a bore extending therethrough adapted to receive the distal portion of the pusher rod. In yet another embodiment, one of the prosthesis attachment assemblies may include a pusher rod with a male threaded first distal portion and an male threaded second distal portion. The second distal portion has a diameter greater than the diameter of the first distal portion and is located proximal to the first proximal portion. The prosthesis mounting assembly includes a threaded proximal opening for threadingly engaging a second distal portion of the pusher rod and a distal opening having a diameter less than a diameter of the second distal portion of the pusher rod. The bore provided further comprises a pusher block extending completely therethrough. A chamber having a diameter greater than the diameter of the second distal portion of the pusher rod is provided between the first opening and the second opening. In other features, one of the prosthesis attachment assemblies includes a pusher block with a bore extending therethrough, a pusher rod extending through the bore of the pusher block, and a distal tip of the pusher rod for coupling. A proximal portion and a distal portion adapted to couple to the prosthesis.

The mounting tool of the present invention can be used as follows. Once the damaged natural disc tissue is removed from the patient and the area is prepared to receive an artificial prosthesis, such as an artificial disc,
The artificial disc is inserted between the levers of the mounting tool so that the posterior side of the disc abuts the distal end of the pusher block. The distal tips of the levers are then positioned between the vertebral bodies so that the outwardly facing surface of each lever contacts the opposing vertebral bodies. Once this position is achieved and the pusher rod is advanced distally, the pusher block and artificial disc will likewise move distally along the inner surface of the lever. As the artificial disc and pusher rod move distally or anteriorly, the levers move away from each other, thereby causing a vertical separation of adjacent vertebral bodies. In order to achieve the correct position of the artificial disc, the distally facing surface of the pusher block needs to contact the vertebral body. Once such contact is achieved between the distal-facing surface of the pusher block and the vertebral body,
The artificial disc is properly positioned. Thus, the tool allows for proper positioning of the artificial disc between the vertebral bodies while minimizing distraction of the vertebrae without over or under insertion of the artificial disc. To remove the tool, a slap hammer or similar device may be used to exert a proximally directed force on the tool and withdraw the blade tip without removing the implant.

The subject matter of the present invention will be fully understood upon reading the following detailed description with reference to the accompanying drawings.

[0017]

DETAILED DESCRIPTION OF THE INVENTION The present invention provides a mounting tool that helps efficiently and effectively position an article, such as an artificial disc, between adjacent vertebral bodies. The mounting tool can be provided as a kit with modular components that allow the surgeon to choose from a variety of components to assemble the mounting tool optimized for the intended application. Although the present invention will be described primarily as used to attach artificial discs between adjacent vertebral bodies, the present attachment tools will place other elements between the vertebral bodies or elsewhere within the patient's body. Can be used to position. Exemplary elements that can be placed between the vertebral bodies include, but are not limited to, interbody cages, fixation devices, spacers, grafts, and the like.

As shown in FIGS. 1-5, the installation tool 10 of the present invention has opposed levers 12, 14 which are respectively distal portions 12A, 14A and proximal handle portions 12B, 14B. have. Levers 12 and 1
A fulcrum means 16 and a pusher block 18 are provided between the four, and the pusher block is arranged on the distal side of the fulcrum means 16. The pusher block 18 has a bore extending at least partially from the initial location located distal to the fulcrum means 16 to the final location located adjacent the distal end of the lever. Can move selectively. A pusher rod 20 that facilitates selective movement of the pusher block has a proximal handle end 20B and a distal end 20A extending into the pusher block bore. Although not an essential part of the present invention, a prosthesis, for example, an artificial intervertebral disc 24,
Located between the levers on the distal side of the.

Preferably, the levers 12 and 14 are elongated elements that are mirror images of each other. There is no upper or lower (top) in the absolute sense of the tool 10. This is because any surface can be used as the "top or top" surface. However, for ease of reference, the lever may be described herein with respect to the orientation shown. For example, the lever 12 and its components may be referred to as the top side, upper or upper lever, and the lever 14 may be referred to as the bottom side, lower or lower lever.

With further reference to FIGS. 1-5, the lever 1
2, 14 are the distal ends 12A, 14A and the proximal end 12
B and 14B. The proximal end 12B of each lever,
14B is preferably shaped to facilitate gripping and handling of the tool. The proximal end of each lever is
It should consist of about half the length of each lever. In one embodiment, the shoulder 26 marks the end of the proximal portion of the tool and the beginning of the distal portion of the tool. As shown in FIGS. 1 and 3, the proximal portion of each lever preferably has a width (W _p ) that is greater than the width (W _d ) of the distal portion of each lever.

The proximal portion 12B of each lever is a fulcrum means 1
It may have a recessed area 28 for receiving 6. As shown in FIGS. 1 and 8, the recessed area 28 is formed by the lever 12B,
14B in the form of a substantially rectangular notch on both sides. This recessed area 28 allows the lever to comfortably house the fulcrum means 16 as described below. The recessed area 28 is preferably formed slightly proximal of the shoulder 26. In one embodiment, the recessed area 2
8 is about 10 mm to 100 mm from shoulder 26
It begins at the proximal side. The recessed area 28 is typically about 1
It has a length in the range of 0 mm to 40 mm and is recessed by about 1 mm to 40 mm.

The proximal region of each lever 12B, 14B has a bore 30A, 30B adapted to receive a bolt 32.
The bolt also allows control of the spacing between the levers, thus allowing the pusher block to accurately engage the metal portion of the artificial disc. As shown in FIG. 8, the bolt 32 has a shaft 35 with a head 34 and a threaded region 36.
Internal threads 36 are preferably formed within bore 30A.

The distal portion 12A, 14A of each lever includes side surfaces 46, 48, outwardly facing surfaces 38, 40 (shown in FIG. 8 as top and bottom, respectively) and the artificial disc during the mounting procedure. It has inwardly facing surfaces 42, 44 on which 24 can rest. The outward and inward facing surfaces of the lever are preferably substantially smooth. However, the inwardly facing surfaces 42,44
May have surface features that can mate with complementary surface features formed on the implant. For example, each lever 1
2 and 14 are formed on inwardly facing surfaces 42 and 44 and are correspondingly slidably accommodated in rails or tracks (not shown) in grooves or channels formed in the implant. ). As a result of surface features formed on the inwardly facing surfaces 42,44 of the levers 12,14, the width (W _d ) of the distal portion of each lever is the width (W _p ) of the proximal portion of each lever. ) Is substantially the same as or larger than this.

Distal portions 12A, 14 of levers 12, 14
A is a blade tip 5 formed at the distal end of the lever
It is better to further have 0A and 50B. The blade tips are sized and shaped to facilitate placement between the vertebral bodies 201, 202. The outwardly facing surfaces 52A, 52B of the blade tips may be configured to have beveled or rounded surfaces. In one embodiment shown in FIG. 4, the blade tip 12 _c
C, 14 _c C may be substantially curved or beveled in an up or down direction to facilitate placement of blade tips 12 _c C, 14 _c C between adjacent vertebrae. . In the illustrated embodiment, the distal tip of the rod 20 _c, the blade tip 50A which distal portion of the rod 20 _c is bent,
It has a spring 2 which allows it to bend or conform to the shape of 50B. The proximal end 4 of the spring 2 may be screwed or otherwise attached to the distal end of the rod 20 _c , with the end 6 of the spring 4 being the proximal end of the pusher block 18 _c. It is good to attach to.
Preferably, the pusher block 18 _c includes a protrusion adapted to extend into the pusher block 18 _c a bore provided in the spring 4 so as to bond the spring 4.

The thickness of the lever, measured at the blade tip when the tool is closed as shown in FIG. 1, is determined by the fulcrum means between the outwardly facing surfaces 38, 40 when the tool is in the closed position. It should be much smaller than the thickness of the lever measured near. Preferably, the thickness measured at the blade tip is about 0.5 mm to 2 mm. The portion of each lever 12A, 14A located adjacent the proximal end of the blade tip 50A, 50B may have a stop surface 54. The substantially vertically oriented and distally oriented stop surface 54 is adapted to abut the vertebral body during a surgical procedure in which elements such as artificial discs are mounted between adjacent vertebral bodies. There is. Stop surface 54 can take a variety of forms. In one embodiment, shown in FIGS. 2 and 12A-14, the stop surface has a profile that is substantially concave when viewed in a vertical plane.

As shown in FIGS. 8 and 9, the lever 12,
The side surfaces of the distal portions 12A, 14A of 14 may have rails 56, 58 located opposite each other with a recessed track 60 provided therebetween. By forming such a recessed track 60 in the distal sidewalls of the levers 12,14, these elements have a profile that is substantially I-shaped or T-shaped as shown in FIGS. The rails 56, 58 and track 60 should be effective in facilitating smooth yet efficient movement of the pusher block, as described below.

Those of ordinary skill in the art will appreciate that the lever may vary in size and shape. However, generally speaking, the overall length of the lever is 200 mm to 400 mm and the proximal portions 12B, 14B (from the proximal end to the shoulder 26) are about 100 mm to 300 mm in length and the distal portion 12A. , 14A (from the shoulder 26 to the tip of the blade) has a length of about 100 mm to 300 mm.

In one embodiment shown in FIGS. 1-3 and 8, the fulcrum means 16 is a substantially block-shaped body with substantially vertical sidewalls 62. The upper surface 64 and the lower surface 66 of the fulcrum means 16 have recesses or grooves 68, which are each constituted by bottom walls 70, 72 and opposing inner side walls 74. The core section 78 is the bottom wall 7
It is located between 0.72. The core section 78 preferably has a central bore 80 through which the pusher rod can pass. In the illustrated embodiment, each bottom wall 7
0 and 72 have mounting posts 82. As shown in FIG. 8, a biasing element 84 ', such as a coil spring, may be fitted into each of the mounting posts 82, and the mounting posts may be located within the bores 31A, 31B of the levers 12,14.

The fulcrum means 16 allow the substantially intermediate portions of the lever to be separated, while the proximal handle portions 12B, 14B are closed together so that the distal portions 12A, 14A can be opened or separated from each other. Can take virtually any size and shape. Generally, the height of the vertical sidewalls 62 is about 20 mm to 70 mm and the core section 78
The height (shown in FIG. 9) is approximately 5 mm to 30 mm. The length of the core section 78 may be about 5 mm to 40 mm.

Those skilled in the art will further appreciate that the fulcrum means can take on various other shapes, sizes and mounting configurations. The embodiments described above are intended to show an exemplary fulcrum means design and mounting scheme.

The bolt 32 can be used to adjust the height / spacing of the lever, as described above. Bore 30
One of the A and 30B has an internal thread 37 that is screwed onto the threaded portion 36 of the bolt 32. Tightening or loosening the bolts results in the spacing between the levers /
The distance will increase or decrease.

Pusher block 18 is preferably in the form of a substantially block-like object with vertical sidewalls 84 defining an upper recess 86 and a lower recess 88, as shown in FIG. , Each recess is constituted by a bottom wall 90 and side walls 92 facing each other and facing inward. Each inwardly facing sidewall 92 is preferably fit within a recessed track 60 formed in the distal portion 12A, 14A of the lever.

[0033] In another embodiment shown in FIG. 10, the side wall 92 'is oriented in the inward of the pusher block 18 _a, has a rail 95 extending from the proximal end of the pusher block 18 _a to distal end ing. Each rail 95 corresponds to each lever 1
It forms a groove or track 97 'that can be fitted with 2, 14 rails 56 or 58. Pusher block 18 _a
Rails 95 and tracks 97 'on the top and bottom sides limit the movement of the levers 12, 14 relative to each other. Movement in use, to the proximal side of the pusher block 18 _a is moved toward the closed position the blade tip 50A, the 50B,
The proximal portions of the levers 12 and 14 are provided with the recess 68 of the fulcrum means 16.
(Fig. 8) It is effective to store it completely. Once the pusher block 18 is positioned just distal to the fulcrum means 16, the levers 12, 14 are effectively locked in the closed position.

Referring back to FIG. 9, the core section 91 of the pusher block 18 includes an upper bottom wall 90 and a lower bottom wall 90.
Located between and, the core section has a proximally facing wall 96 and a distally facing wall 97. In one embodiment, the height of the core section 91 is lower than the height of the prosthesis to be attached and thus the lever 1
The inwardly facing surfaces 42,44 of 2,14 allow access to the prosthesis. As a modified example, as shown in FIG. 11, in the core section 91, the prosthesis 24 _b is provided in each lever 1.
It may have a height h _c slightly greater than the height of the prosthesis 24 _b so as to prevent contact with the inwardly facing surfaces 42, 44 of 2 _b , 14 _b . Thus, the prosthesis 24 _b, when coupled to the pusher block 18 _b or pusher rod 20 _b, spaced from the lever 12 _b, 14 _b. The distally facing wall of pusher block 18 may have a shape that matches the shape of the prosthesis. In the illustrated embodiment, several pusher blocks 18, 18 _a , 18 _b may be provided, each pusher block having a different size and / or shape optimized for use with a particular prosthesis or patient. have.

As mentioned above, the pusher rod 20 may be used to actuate the pusher block 18. Pusher rod 20 is preferably an elongated cylindrical member having a proximal end 20B and a distal end 20A. This rod is located at the proximal end 12B, 14B of the lever 12, 14.
Positioned in relation to each other and extend into or through the bore 80 of the fulcrum means 16. The rod 20 is preferably coupled to the pusher block 18 such that the back and forth movement of the pusher rod directly moves the pusher block. Alternatively, pusher block 18 may have a bore extending completely therethrough such that a rod 20 may be provided through the bore for direct coupling to a prosthesis or to a connector element. Of course, this connector element couples to the prosthesis.

The pusher rod 20 includes the levers 12, 14
It may have stop features that prevent it from being removed from the recess formed in the pusher block, but this is optional. As shown in FIGS. 4 and 5, the rods 20, 20 _c abut the opening of the fulcrum means 16 on the proximal side of the bore 80, thereby causing the levers 12, 14 to move.
And a stop surface 17 for blocking proximal movement of the fulcrum means 16. The stop surface 17 may be formed by varying the diameter of the pusher rods 20, 20 _c so that the proximal part of the rod is
It has a diameter greater than the distal portion of 0,20 _c and greater than the bore of pusher block 18. Alternatively, the stop surface 17 may be formed of an annular flange or similar protruding structure.

The pusher block 18 and pusher rod 20 may include various features, such as connector elements, that connect the block 18 to the rod 20 or the rod 20 and / or the block 18 to the prosthesis 24. As a non-limiting example, FIG. 9 illustrates an embodiment in which the proximally facing wall of pusher block 18 has a blind bore 98 with internal threads 100. Screw thread
It is adapted to mate with complementary threads 102 formed on the distal end 20A of pusher rod 20, which allows pusher rod 20 to securely engage pusher block 18. The distally facing wall 97 of the pusher block may have a recessed region 104 adapted to mate with the artificial disc 24. As shown, the recessed region 104 is sized and shaped to allow an artificial disc to fit loosely therein. One of ordinary skill in the art will appreciate that the recessed area should have dimensions slightly larger than the dimensions of the disc to avoid friction fits that may prevent the prosthetic disc from spontaneously disengaging from the tool. . FIG. 17 is a diagram illustrating one embodiment of a recessed region 104 with a generally arcuate shaped contact wall 106. Preferably the contact wall 10
6 is substantially concave and is suitable for maintaining contact over a substantial surface area of the generally curved (convex) posterior surface of the artificial disc 24.

FIGS. 11 and 23-24B show another embodiment of a connector element coupling the pusher rod 20 _b to the pusher block 18 _b and optionally the prosthesis 24 _b . 24A and FIG.
As shown in (B), pusher block 18 _b has a bore 401 with a proximal opening 406, a distal opening 405 and a chamber 408 extending therebetween. Proximal opening 406 and distal opening 405 each preferably have substantially the same diameter and chamber 40.
It has a diameter smaller than the diameter of 8. FIG. 24 (B)
As shown, the proximal opening 406 has a threaded region 403 that mates with and mates with a threaded region 411 formed on the rod _20b (FIG. 23).
However, proximal opening 406, various engagement elements that fit forms a relationship with a groove formed on the rod 20 _b, may have, for example, O-ring. Distal opening 405
Is not threaded and is thus effective in preventing the threaded portion of rod 20 _{b from} being screwed into distal opening 405. The proximal opening 406 also may also include a tapered portion 409 abuts forms the correspondence between the tapered portion 410 formed on the rod 20 _b.

FIG. 23 shows FIGS. 24 (A) and 24 (B).
FIG. 9 shows a pusher rod 20 _b suitable for use in the embodiment of pusher block 18 _b shown in FIG. The pusher rod 20 _b has a distal tip 413 and a connector segment 4 extending proximally from the distal tip 413.
12 and the distal end 4 integral with the connector segment 412
18 and an annular flange 411 with a proximal end 416 coupled to the rod 20. Proximal end 416 and distal end 418 may be tapered to facilitate rod 20 _b in and out of pusher block 18. The distal tip of the rod 20 _b 413 may have to bind to the prosthesis, thus may have an engagement element. As shown in FIG. 23, the distal tip 413 is threaded at 415 for mating engagement with threads formed in a bore in the prosthesis. .

In use, rod 20 _b is inserted into proximal opening 406 of pusher block 18. Distal tip 41
3 and the connector segments 412, it is preferable to insert into the bore until the threaded annular flange 411 engages the pusher block 18 _b of the threaded region 403. The flange 411 may then be turned and thus screwed into the bore 403 to position the flange 411 within the chamber 408. Further moved distally the rod 20 _b,
Would be a large portion of the distal tip 413 and connector rod 412 is inserted into the distal opening 405 of the pusher block 18 _b. However, if the distal opening 405 were unthreaded and there were dimensional differences, this would prevent the annular flange 411 from exiting the chamber. Once the annular flange 411 is placed in the chamber, the rod _20b is free to rotate. Then, by rotating the rod 20 _b, it can be removed securely engaged to the prosthesis, or a rod from the prosthesis. In the illustrated embodiment, the threads provided on the annular flange 411 have a distal tip 413.
Is oriented in the opposite direction to the threads 415 provided on the. This prevents rod 20 _{b from} unthreading and disengaging from proximal opening 406.
_b can be removed from the prosthesis.

Those skilled in the art will appreciate that annular flange 411 and distal tip 413 can employ various engagement elements other than threads. For example, other locking elements may include snap-fit engagement means, friction engagement means, bayonet locks, luer locks, or any other type of connector.

FIG. 21 illustrates another embodiment of a connector element coupling pusher block 18 _d to prosthesis 600. A gripping element or gripper 500 for gripping the prosthesis 600 is provided as shown. The grip 500 includes a proximal portion 502 and a distal portion 50.
Have four. Proximal portion 502 has an elongated, substantially cylindrical cross-section with an outer diameter d, and further has a bore 506 extending therethrough along the instrument longitudinal axis l. The bore 506 defines the distal end 20A of the rod 20.
And may have an internal thread for threadably receiving the threaded distal end 20A of the rod 20. One of ordinary skill in the art will appreciate that various alternative engagement mechanisms may be used to couple the grip 500 to the rod 20. The outer diameter d of the cylindrical proximal portion 502 is
It bores 80 _d of the proximal portion 502 the pusher block 18 _d
It is necessary that the smaller than the diameter of the bore 80 _d to be inserted into. The proximal portion 502 is preferably the distal portion 5
It has a tapered region 505 that increases toward 04.

The distal portion 504 of the gripper 500 is oriented to extend in a direction substantially transverse to the instrument's longitudinal axis 1 which is the first wing-shaped component 508. And a second wing-shaped component 509, each of which is arranged on the opposite side of the longitudinal axis l, spaced apart from each other by a gap 513. First part 508 and second part 509
Have proximally extending portions 510, 511 that are not attached to each other and that connect to the proximal portion 502. The portions 510 and 511 extending to the proximal side are the proximal portions 5.
It tapers inward toward 02. As a result, the gripper 500 has a gradual increase in diameter d towards its distal portion 504. In the exemplary embodiment, gap 513
Thus, the first component 508 and the second component 509 can be pinched together.

The first part 508 and the second part 509 each have distally directed walls 520,521. The walls 520, 521 may have a shape that matches the shape of the prosthesis, and these walls preferably fit around a substantially cylindrical or disc-shaped prosthesis 600 as shown. It is slightly concave. Each component 508, 509 may have a protruding element 515, 516 on a distally facing wall 520, 521 capable of engaging the prosthesis 600. Protruding element 5
15, 516 may be, for example, triangular, diamond-shaped, or hook-shaped members that may engage prosthesis 600 when placed within openings 518 formed in prosthesis 600.

[0045] In use, insert the gripper 500 into the bore 80 _d in the pusher block 18 _d, which binds to the rod 20. The protruding elements 515, 516 are inserted into the openings 518 formed in the prosthesis 600, which causes the rod 20 to rotate, which engages the gripper 500, thereby causing the gripper 5 to rotate.
Move 00 proximally. Pulling the jaws 500 in the proximal direction by the rod 20, the tapered portion of the gripper 500 is drawn into bore 80 _d, combining thereby knob with the first part 508 and the second part 509. As a result, the protruding elements 515, 516 grip and hold the prosthesis 600. The prosthesis 600 may then be positioned between adjacent vertebrae, once positioned, the rod 20 may be rotated in the opposite direction to grasp the gripper 50.
It is better to release 0 so that the first part 508 and the second part 509 can return to their separated state, thus releasing the prosthesis 600.

In the illustrated embodiment, pusher block 1
8 _d has a pusher block 18 _d recessed areas 19 are formed on each of the side walls of that can be inserted gripper 500 into the bore 80 _d. The first part 508 and the second part 509 fit within the recessed area 19 when coupled to the pusher block 18 _d . Rod 20 preferably has a stop surface to prevent further insertion of the pusher block 18 _d of rod 20 into bore _d in (not shown). The stop surface needs to be positioned so that the distal portion of rod 20 can extend through bore 80 _d to engage grip 500.

The insertion depth of the cage 600 between the vertebral bodies is determined by the length of the grip 500 and the depth of the recessed portion 19. For example, the length of the grip 500 and the depth of the recessed region 19 may be substantially the same so that the distal end of the pusher block is aligned with the distal end of the grip. In use, the pusher block and the distal end of the grasper are aligned with the outer edges of adjacent vertebrae. As a result, the implanted disc is substantially aligned with the outer edges of adjacent vertebrae. Alternatively, the grip 500 may have a length that is greater than the depth of the recessed portion 19 so that the insertion depth of the disc substantially depends on the difference between the length of the grip 500 and the depth of the recessed portion 19. Try to be equal.

14 and 15 show the installation tool 10 '.
Is the proximal handle portion 12B ', 1 of the lever 12', 14 '
4B 'is a diagram showing a modified embodiment having a locking mechanism 108 provided in 4B'. FIG. A locking mechanism, which may consist of a latch and a groove, only secures the proximal handle portion of the lever in the desired position, which prevents complete separation of these elements. FIG. 14 shows the tool 10 'in a position where the proximal portions 12B', 14B 'of the levers are in their open or non-actuated position. Lock mechanism 108
Prevents further opening or separation of 12B ', 14B' of the proximal portion of the lever. However, as shown in FIG. 15, the locking mechanism is still in the handle 12B ',
The 14B's can be activated or closed together.
The purpose is to use a tool and attach a prosthesis, such as an artificial disc 24. Lock mechanism 108
One advantage is that the intervertebral disc is less likely to accidentally disengage from the tool during the pre-operative attachment operation of the tool.

In FIG. 18, the mounting tool 300 has the lever 3
Proximal or handle portion 312B, 314B of 12,314
4 illustrates an embodiment of the present invention having a plurality of protrusions 302, 304 formed thereon. Preferably, the protrusion 302,
304 is formed on the side surface of the handle portion. In the illustrated embodiment, two protrusions are formed on each of upper lever 312 and lower lever 314. Although shown as having a substantially cylindrical shape, the protrusions 302,
304 can be of virtually any shape. For example, referring back to FIG.
The proximal ends 12B, 14B of the may be T-shaped. The T-shaped handle or protrusion may help facilitate distraction of the blade tips 350A, 350B with a tool such as a slap hammer 800 or a slap fork (shown in FIG. 22). The slap hammer 800 is disposed around the levers 12 and 14 and slides proximally to exert a proximally directed force on the T-shaped handle or protrusion 3.
Add to 02,304. T-shaped handle or protrusion 302,
The range of dimensional variation of 304 may be wide. However, in general, a T-shaped handle or protrusion 3
02 and 304 are approximately 3 from the side surface of the levers 312 and 314.
Only a distance of 50 mm is projected.

Although T-shaped protrusions and handles 302, 304 are shown, it will be understood by those skilled in the art that the handles can take a variety of forms that allow the slap hammer to be used with the instrument. See.

With reference to FIGS. 18-20 (B), the installation tool 300 includes a blade tip length (ie, the distance between the distal end 306 of the blade tips 350A, 350B and the stop surface 354). Further features may be provided to allow selective adjustment of). In such an embodiment,
Each distal portion 312A, 314A of the lever has a stop member component 307 and a blade member component 308, which are longitudinally separable from each other. Parts 30
The separability of 7 and 308 allows the blade tip length to be adjusted by changing the relative positions of the components 307 and 308.

As shown in FIGS. 18 and 19, the tool 3
00 has a connection box 309 which accommodates the components 307 and 308 and fixes them. Connection box 30
The part 307 </ b> A of the stop member 307 as a component that fits with the inner surface of the cover 320 of FIG. Similarly, the abutting inner surface of the cover 320 of the connection box 309 also has the groove 310 and the protrusion 311. As further shown, the cover 320 includes a suitable fastener, such as screws 32.
It is fixed to the levers 312 and 314 by 2. A biasing element, such as a compression spring (not shown) is preferably such that the cover 320 and the groove and 310 of the stop member part 307 and the ridges 311 fit together and remain fixedly secured to each other. Used to bias the connection box to the position. As shown in FIG. 19, a suitable marker 32
5 for indicating the position of the stop member 307 as a part with respect to the blade member as a part.
It is good to be provided on 7. Although FIG. 19 only shows the configuration of lever 12 in detail, it will be appreciated that the same configuration is used for lever 14.

The result of such selective adjustment is shown in FIGS. 20 (A) and 20 (B), in which the blade tip length is larger than that in FIG. 20 (B). (A) is larger.

FIGS. 1 and 12A to 13B.
Show in sequence the use of tool 10 for attachment of artificial disc 24. First, the tool is assembled as shown in FIG. 1 and the posterior surface 27 of the disc with pusher block 18 positioned in its initial position such that its proximally facing wall 96 reaches shoulder 26. Is placed against the wall 97 facing the distal side of the pusher block. With the handles 12B, 14B in the open position and the blade tips 50A, 50B closed, the blade tips are squeezed between adjacent vertebral bodies 201, 202 so that at least the anterior portions of the vertebral bodies are slightly To separate. The blade tips 50A, 50B are fully inserted between the vertebral bodies as shown in FIG. 12A to allow the vertebral stop surface 54 to abut the posterior side 204 of the vertebral bodies 201, 202. There is a need. Next, pusher rod 20 is pushed forward to move pusher block 18 and artificial disc 24 distally. Also, pusher block 1
8 and the artificial disc 24 are moved anteriorly or distally to further separate the blade tips 50A, 50B and thus FIG.
The vertebral bodies 201 and 202 are further separated as shown in FIG. The pusher block 18 and artificial disc 24 are then advanced until the disc is properly attached between adjacent vertebral bodies as shown in FIG. 13A. 12 (B) and 13 (A) show that the constant separation of the vertebral bodies only occurs to the extent necessary to insert the disc. Excessive distraction or separation of the vertebral body
It does not occur because vertebral body separation is caused by the height of the pusher block.

The mounting tool of the present invention may be provided as a kit having modular components that allow the surgeon to assemble the mounting tool optimized for the intended use by choosing from a variety of components. . The kit preferably comprises several different rods, pusher blocks and connector elements,
For example, it has a gripper 500, each of which is adapted for use with a particular implant. For example, the kit has 3
It may have a pusher block of a type, each pusher block adapted to mate with a particular prosthesis. As shown in FIG. 21, pusher block 18 _d may be used in combination with grasping tool 500 to insert a cage-type separating prosthesis. As a modified example, FIG.
A pusher block 18 for inserting an artificial disc may be provided, as shown in FIG. Those of ordinary skill in the art will appreciate that the mounting tool may have various components with various combinations of features. Further, these components can be adapted for particular types of prostheses or other components.

Those skilled in the art will appreciate other features and advantages of the invention based on the above-described embodiments. Therefore, the scope of the present invention is defined based on the description of the claims rather than the matters specifically shown and described. The entire contents of all technical documents cited herein are hereby incorporated as part of the present specification.

Specific embodiments of the present invention are as follows. (1) The medical instrument installation tool according to claim 1, wherein the bore is a blind bore, and the distal end portion of the pusher rod is fitted with the blind bore of the pusher block. (2) Each lever has a surface feature located between its proximal and distal ends that slides with complementary shaped surface features formed on the prosthesis. The medical device installation tool according to claim 1, wherein the medical device installation tool can be freely fitted. (3) The bore extends completely through the pusher block and the distal end of the pusher rod has a distal tip that penetrates the bore of the pusher block and is adapted to be coupled to a prosthesis. The medical device attachment tool according to claim 1, wherein (4) The pusher block has a height such that the lever can be separated from the prosthesis so that the lever is spaced from the prosthesis when the pusher rod is coupled to the prosthesis. The medical device attachment tool according to aspect (3). (5) The pusher rod has an externally threaded first distal portion and an externally threaded second distal portion, the second distal portion having a diameter greater than the diameter of the first distal portion. Have
The medical device mounting tool according to embodiment (3), wherein the medical device mounting tool is arranged on the proximal side of the first distal portion.

(6) The pusher block bore has a threaded proximal opening for threadingly engaging the second distal portion of the pusher rod, the distal opening of the pusher block being the second portion of the pusher rod. A diameter smaller than the diameter of the distal portion of the chamber, the chamber being provided between the first opening and the second opening, the chamber having a diameter of the second distal portion of the pusher rod. A medical device installation tool according to embodiment (5), characterized in that it has a larger diameter. (7) The medical device installation tool according to the embodiment (6), wherein the pusher rod can freely rotate when the second distal portion is arranged in the chamber of the pusher block. (8) An embodiment (6) characterized in that the externally threaded first distal portion of the pusher rod is threaded in a direction opposite to the direction of the threads of the externally threaded second distal portion. ) The medical device mounting tool described. (9) The bore extends completely through the pusher block, the distal tip of the pusher rod is adapted to penetrate through the bore of the pusher block, and the distal tip of the pusher rod is further attached to the prosthesis. A medical device installation tool according to claim 1, adapted to be coupled to a releasably engageable gripping element. (10) The bore extends completely through the pusher block, the distal tip of the pusher rod is adapted to extend through the bore of the pusher block, and the distal tip of the pusher rod further secures the prosthesis. The medical device installation tool of claim 1, wherein the medical device installation tool is adapted to engage.

(11) The grasping element has an elongate proximal portion having a bore formed therein and a distal portion releasably engageable with the prosthesis, the proximal portion being in the bore at the distal end of the pusher block. The medical device attaching tool according to the embodiment (9), which has an outer peripheral portion adapted to be fitted. (12) The distal portion of the grasping element has opposing first and second parts movable between a first open position and a second closed position capable of engaging the prosthesis. The medical device attaching tool according to the embodiment (11), characterized in that (13) The distal end of the pusher rod is threadedly engaged with the bore of the grasping element, and when the pusher rod is rotated in the first direction, the elongated proximal portion of the grasping element is proximal within the bore of the pusher block. To move the first part and the second part to the second closed position, while
Rotating the pusher rod in the second direction causes the elongate proximal portion of the grasping element to move distally out of the bore of the pusher block to bring the first and second parts into the first open position. A medical device installation tool according to embodiment (12), which is adapted to be moved. (14) The medical device installation tool according to embodiment (13), wherein each of the first part and the second part has at least one surface feature engageable with the prosthesis. (15) The pusher block has an upper concave portion and a lower concave portion, and each concave portion is adapted to seat one lever, and the upper concave portion and the lower concave portion each have a substantially horizontal bottom wall. Have opposing substantially vertical walls, each of which extends between the proximal and distal ends of the pusher block and is capable of retaining a lever. The medical device installation tool according to claim 1, further comprising a rail.

(16) The instrument mounting tool according to claim 1, wherein the handle portion of each lever is substantially T-shaped. (17) The medical instrument attaching tool according to claim 1, wherein the pusher rod has a stop member capable of limiting the forward movement of the pusher rod through the opening of the fulcrum means. (18) The medical instrument installation tool according to claim 1, wherein the distal portion of each lever has a curved tip portion. (19) One of the prosthesis mounting assemblies includes a pusher block having a proximal end, a proximal end and a bore extending therethrough, and slidably disposed between the levers. 3. The medical device mounting kit according to claim 2, comprising a pusher rod penetrating the bore of the block and a gripping element releasably engageable with the prosthesis. (20) The gripping element is between an elongated proximal portion adapted to fit in a bore at the proximal end of the pusher block and a first open position and a second closed position capable of engaging the prosthesis. 20. The medical device attachment kit of embodiment (19) having opposing first parts movable and distal parts having second parts.

(21) When the distal end of the pusher rod is screwed into the bore of the gripping element and the pusher rod is rotated in the first direction, the elongated proximal portion of the gripping element is within the bore of the pusher block. To the proximal side to move the first part and the second
Of the gripper element is adapted to move to a second closed position, whereas rotation of the pusher rod in a second direction causes the elongated proximal portion of the gripping element to move distally of the pusher block. A medical device mounting kit according to embodiment (20), characterized in that it is adapted to move out of the bore to move the first part and the second part to the first open position. (22) One of the prosthesis mounting assemblies has a pusher rod with a proximal handle portion and a distal portion having a distal tip adapted to securely engage the prosthesis. The medical device attachment kit according to claim 2, wherein (23) The prosthesis mounting assembly further comprises a pusher block with a proximal end, a distal end and a bore extending therethrough, the distal portion of the pusher rod passing through the bore of the pusher block. An embodiment (2
2) The medical device attachment kit described above. (24) One of the prosthesis attachment assemblies has a male threaded first distal portion and a diameter greater than the diameters of the first distal portion and is close to the first proximal portion. A pusher rod having a male threaded second distal portion disposed distally, a threaded proximal opening threaded with the second distal portion of the pusher rod and a second pusher rod portion. A pusher block having a distal opening having a diameter smaller than the diameter of the distal portion extends completely therethrough and is provided between the first opening and the second opening. And a chamber having a diameter greater than the diameter of the second distal portion of the pusher rod. (25) The medical device attachment kit according to the embodiment (24), wherein the pusher rod is free to rotate when the second distal portion is placed in the chamber of the pusher block.

(26) The medical device attaching kit according to the embodiment (25), wherein the first distal portion of the pusher rod is adapted to be firmly engaged with the prosthesis. (27) One of the prosthesis attachment assemblies comprises a proximal end, a proximal end and a bore extending therethrough,
A pusher block slidably provided between the levers, a pusher rod having a proximal handle portion and a distal portion extending through the bore of the pusher block, and adapted to be coupled to the distal tip of the pusher rod. A plurality of connector elements having a proximal portion and a distal portion adapted to be coupled to a prosthesis.

[0063]

The tool of the present invention for attaching a medical device, for example, an artificial intervertebral disc as a prosthesis, has an artificial structure due to the characteristic structure of the pair of levers, fulcrum means and pusher block as described in claim 1. The intervertebral disc can be easily and properly inserted between adjacent vertebral bodies. More specifically, the pusher block of the installation tool of the present invention is located between two levers and is located at an initial location distal to the fulcrum means and adjacent the distal end of the lever. The artificial intervertebral disc can be efficiently and effectively arranged between the adjacent vertebral bodies because the artificial intervertebral disc can be selectively moved between the adjacent vertebral bodies. Advantageously, a pusher rod is provided which, in association with the pusher block, facilitates movement of the pusher block. Furthermore, the mounting tool of the present invention can be provided as a kit with modular components that allow the surgeon to assemble a mounting tool that is optimized for the intended use by choosing from a variety of components. It is convenient. The structure of such a kit is described in claim 2.

[Brief description of drawings]

FIG. 1 is a perspective view of a mounting tool of the present invention.

2 is a side view of the tool shown in FIG. 1. FIG.

3 is a plan view of the tool shown in FIG. 1. FIG.

FIG. 4 is a perspective view of an installation tool with a curved distal blade tip as another embodiment of the present invention.

FIG. 5 is a side view of another embodiment of the installation tool of the present invention.

6 is a cross-sectional view taken along the line 4-4 of the tool shown in FIG.

FIG. 7 is a sectional view of the tool shown in FIG. 2 taken along the line 5-5.

FIG. 8 is an exploded view of the proximal portion of the tool shown in FIG.

FIG. 9 is an exploded view of a portion of the tool shown in FIG.

10 is an exploded view of another embodiment of the pusher block of the tool shown in FIGS. 1-5. FIG.

FIG. 11 is a side view of a portion of yet another embodiment of a medical attachment tool.

12 (A) and (B) are views showing a part of the sequence of operations of the attachment tool of the present invention during the attachment of the artificial disc.

13 (A) and 13 (B) are views showing a part of the sequence of operations of the attachment tool of the present invention during the attachment of the artificial disc.

FIG. 14 is a side view of one embodiment of the installation tool of the present invention in an initial unlocked position.

15 is a side view of the installation tool of FIG. 14 in a final locked position.

16 is a cross-sectional view taken along the line 11-11 of the tool shown in FIG.

FIG. 17 is a perspective view of a pusher block used in the tool of the present invention.

FIG. 18 is a perspective view of another embodiment of a mounting tool of the present invention.

FIG. 19 is an exploded perspective view of a portion of the installation tool shown in FIG.

20A and 20B are side views of a portion of the distal end of the installation tool of FIG. 18 in a first position and a second position, respectively.

FIG. 21 is a side perspective exploded view of one embodiment of a connector element used in a medical installation tool.

FIG. 22 is an exploded perspective view of a slap hammer device used in the medical installation tool of the present invention.

FIG. 23 is a side view of a portion of the pusher rod used in the medical installation tool of the present invention.

24 (A) is a cross-sectional side view of the pusher block component of the medical installation tool shown in FIG. 11 (B).
FIG. 25 is a plan view of the proximal end portion of the pusher block shown in FIG.

[Explanation of symbols]

10 Installation tool 12,14 lever 14A distal portion 14B proximal part 16 fulcrum means 18 pusher block 20 pusher rod 20A distal end 20B proximal end 24 Artificial intervertebral disc 26 shoulder 38,40 outward facing surface 42,44 inward facing surface 54 Stop surface 56,58 rails 60 Recessed orbit 98 bore

   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Robert Dee Fraser             5064 South Auss, Australia             Tolalia, Mayrtle Bank, Fit             Sher Street 31 (72) Inventor Alexander Grinberg             United States, 02466 Massachusetts             Commonwealth Abe, Newton, New Zealand             New 2265 (72) Inventor John Daniel Malone             United States, 02864 Road Island             Unit 1927, Cumberland, Do State,             Abbott Run Valley Road 50 (72) Inventor Bradley More             United States, 02806 Road Island             Ferry Lane, Barrington, Do State             100 (72) Inventor Michael Jay O'Neill             United States, 02668 Massachusetts             West Barnstable, Ron             Bird Avenue 121 (72) Mark Boomer, Inventor             United States, 02144 Massachusetts             Apartment Nan, Summerville, Tutu             Bar 2, Liberty Avenue 110 F-term (reference) 4C060 LL13 MM24

Claims (2)

[Claims] 1. A medical device installation tool comprising a pair of opposed levers, each having a proximal handle portion and a distal portion, and an opening extending therethrough between the two levers. A fulcrum means having a portion and a proximal end, a distal end and an at least partially extending bore located distal to the fulcrum means provided between the two levers. A pusher block slidably movable between an initial location and a final location located adjacent the distal end of the lever, and a pusher rod with a proximal handle end and a distal end. And a pusher rod slidably mounted through the fulcrum means, the distal end of the pusher rod extending into the bore of the pusher block. 2. A medical device mounting kit, comprising a pair of opposed levers each having a proximal handle portion and a distal portion, and pivoting between the opposed levers. Fulcrum means for movement and a plurality slidably provided between the levers for movement between a first proximal position and a second distal position A prosthesis mounting assembly, each prosthesis mounting assembly having a handle portion and a prosthesis capable of moving the prosthesis mounting assembly between a first proximal position and a second distal position. A medical instrument attachment kit having a distal prosthesis handling element adapted to be positioned between adjacent bone tissues.