CN107303199B

CN107303199B - Bone fixation device

Info

Publication number: CN107303199B
Application number: CN201610238162.8A
Authority: CN
Inventors: 许世雄
Original assignee: Spirit Spine Holdings Corp Inc
Current assignee: Spirit Spine Holdings Corp Inc
Priority date: 2016-04-18
Filing date: 2016-04-18
Publication date: 2019-12-24
Anticipated expiration: 2036-04-18
Also published as: CN107303199A

Abstract

A bone fixation device comprises an extrusion unit, an expansion structure, a coating unit and an anti-retreat unit. The extrusion unit includes first, the second extruded piece, when the second extruded piece moved toward the direction of the distal end of first extruded piece, the extending structure was first, the second extruded piece extrudees and expandes, first side hole is aimed at the second side hole, make first, the second shaft hole is by first, the second side hole communicates with each other with the space of extending structure, the cladding unit is propped open by the extending structure, first extruded piece is by preventing moving back the unit and selectively restricting the second extruded piece, make the unable direction rectilinear movement toward the proximal end of first extruded piece of second extruded piece, make this extending structure keep at the state of expanding. Therefore, the invention can prevent the expansion structure from contracting by the anti-retreat unit, so as to expand the coating unit.

Description

Bone fixation device

Technical Field

The present invention relates to a bone fixation device, and more particularly, to a bone fixation device having a covering unit and an unfolding structure, which can be unfolded by a mechanical force to open a bone.

Background

In the operation of injecting or inserting medical filler into bone, the following types of common techniques are available:

the first prior art uses existing mechanical reaming devices (e.g., U.S. Pat. nos. 20110196494, 20110184447, 20100076426, 20070067034, 20060009689, 20050143827, 20220052623, 6354995, 6676665) to ream a bone to create a space within the bone, and after reaming, the reaming device is removed, then placed in a sheathing unit, and then subjected to surgery to pour or insert medical filler. Such prior art has the following disadvantages: the crushed spongy bone fragments of the existing mechanical reaming device often fall into the mechanical reaming device, so that the mechanical reaming device is blocked, the reamed cell assembly cannot be withdrawn (recovered to a contracted state), and the whole mechanical reaming device is blocked at a reaming part and cannot be taken out.

The second type of prior art uses the existing filling type reaming device (for example, us patent 5972015, 6066154, 6235043, 6423083, 6607544, 6623505, 6663647, 6716216) to ream the bone, create a space in the bone, remove the reaming device after reaming, then put in the covering unit, and perform the operation of pouring or inserting medical filler. Because most of the filling type hole expanding devices put an air balloon into a skeleton, liquid (such as water) is filled into the air balloon (various air balloons are used according to different requirements) by utilizing high pressure, so that the air balloon is expanded to push cancellous bone in the skeleton, and the hole expanding purpose is achieved; however, this device/method has a number of disadvantages, such as: the balloon must be connected to a nozzle (nozzle), so that when liquid is injected under high pressure, the balloon may fall off the nozzle, and even the balloon may break.

The third type of prior art is to directly place the covering unit into the skeleton and fill the medical filler without pre-reaming, and to achieve the effect of opening the skeleton by using the pressure of the medical filler when filling the covering unit. Such sheathing units, when impregnated with medical filler, have the efficacy of both reaming devices and bone fixation devices (e.g., taiwan patent publication nos. I321467, I392474; U.S. patent No. 6248110), or even abandon the sheathing unit and directly utilize an infusion device to infuse the medical filler into the surgical site to enhance the fixation of the surgical site (e.g., U.S. patent No. 5514137). Such prior art has the following disadvantages: because the hole expansion is not carried out firstly, the range of the perfusion can not be accurately controlled, so that the direction of the perfusion finished product can be different from the original expected condition of a doctor; in addition, even after the medical filler is filled, the coating unit is found not to completely support the skeleton, or the medical filler flows around the skeleton and flows out of the skeleton, or even the concentration of the slurry medical filler is too dilute or the particle size is too small, so that the skeleton cannot be smoothly supported when the medical filler is filled, and the original effect is greatly reduced.

A fourth type of prior art utilizes existing mechanical reaming devices as bone fixation devices (e.g., U.S. patents 20120071977, 20110046739, 20100069913, 20100217335, 20090234398, 20090005821), where the mechanical reaming device is implanted into a bone and the bone is distracted, a medical filler is infused to cover the mechanical reaming device, and the mechanical reaming device and the medical filler are left in the body after infusion. These prior art techniques, without the coating unit, have two very serious problems:

firstly, the method comprises the following steps: the flow direction of the medical filler cannot be effectively controlled, so that the medical filler can flow around the bone and even flow out of the bone; and

secondly, the method comprises the following steps: prior to, during or before the medical filler is injected, the mechanical reaming device is under the influence of external force when in an expanded state, and then contracts inside the bone. Once slightly contracted, the existing mechanical reaming devices will have a reduced effect on distraction. In the severe case, the patient is even completely retracted to the contracted state, so that the mechanical reaming device in the prior art can completely lose the effect of opening the bone.

In order to solve the two problems of the fourth prior art, the applicant has proposed a bone fixation device (taiwan patent publication No. I503097) which utilizes a covering unit to cover the deployment structure of the deployment device, so as to effectively prevent crushed cancellous bone fragments from falling into the deployment device during reaming, and to allow the deployment structure of the deployment device to expand and contract within the bone to perform reaming. In addition, when the medical filler is filled, the device can effectively control the filling range of the medical filler, the medical filler is prevented from mixing in a skeleton, and after the filling is finished, the medical filler can completely cover the unfolding structure of the unfolding device, so that the possibility that the unfolding structure of the unfolding device is contracted is avoided. However, the structure of the expanded structure of the device for deploying the bone fixation device is simple, and the expanded structure of the device cannot be adjusted correspondingly according to different patient conditions because the bone hardness and the bone collapse mode of each patient are not completely the same. Furthermore, in the implementation process, it is found that: when the bone fixing device is used on a patient with high bone hardness, the stretching effect is not as expected.

Therefore, the applicant has further developed a bone fixation device (taiwan patent publication No. 201536248) in which a plurality of expansion structures are disposed on the expansion units, so that the strength of the expansion units can be increased, the expansion units can support a hard bone, and the length and arrangement of the expansion structures can be adjusted to cope with various bone collapse conditions, which is more excellent than taiwan patent publication No. I503097.

Disclosure of Invention

The applicant has not felt the satisfaction of developing a technology sufficient to overcome the problems of the prior art, and thus has continued the development of bone fixation device with the spirit of increasing refinement, and has finally developed a new generation of bone fixation device superior to the applicant's previous generation bone fixation device.

An object of the present invention is to provide a bone fixation device, wherein an extrusion unit extrudes a deployment structure to deploy the deployment structure, and after the deployment structure is deployed, a retraction prevention unit can prevent the deployment structure from slightly contracting or completely retracting to a contracted state when the deployment structure is in the deployed state under the influence of an external force, so that a covering unit is kept in a state of being propped by the deployment structure before the medical filler is filled, during the filling process or before the medical filler is completely filled but is not completely solidified, thereby maintaining the effect of the bone fixation device of the present invention in propping open the bone.

Another object of the present invention is to provide a bone fixation device, in which the screw-type anti-retraction unit can control the expansion and retraction of the expansion structure by the first and second pressing members in a screw manner, so that the expansion structure can be smoothly expanded and retracted in the bone to expand the hole, thereby adjusting the hole expansion direction or the hole expansion range, and further preventing the expansion structure from being slightly retracted or completely retracted to the retracted state when the expansion structure is affected by an external force.

Another object of the present invention is to provide a bone fixation device, wherein when the single-row block barb type anti-receding units are staggered, the first and second extrusion members can control the expansion and contraction of the expanded structure, so that the expanded structure can be smoothly expanded in the bone for reaming; when the single-row block barb type anti-withdrawal units are in contraposition engagement, the unfolding structure can be prevented from slightly contracting or completely withdrawing to the contracted state when being influenced by external force in the unfolded state.

It is still another object of the present invention to provide a bone fixation device, which has a stronger strength against an external force when a plurality of rows of block-shaped barb-type withdrawal prevention units are engaged in alignment, and further has an effect of preventing a deployed structure from being slightly contracted or completely withdrawn to a contracted state when the deployed structure is affected by the external force in the deployed state.

It is still another object of the present invention to provide a bone fixation device, in which the annular barb type withdrawal prevention unit restricts the first and second pressing members from unidirectionally controlling the deployment of the deployment structure, thereby preventing the deployment structure from being slightly contracted or completely withdrawn to the contracted state when the deployment structure is influenced by an external force.

Another object of the present invention is to provide a bone fixation device, wherein when the deployment structure is in the deployment state, the medical filler is sequentially filled in the range covered by the covering unit through the second shaft hole of the second extrusion piece, the second side hole of the second extrusion piece, the first side hole of the first extrusion piece and the gap of the deployment structure.

It is still another object of the present invention to provide a bone fixation device in which first and second side holes extending in staggered directions maintain at least a partial alignment with each other regardless of rotation of first and second extrusions to allow medical filler to pass through the respective first and second side holes.

Another object of the present invention is to provide a bone fixation device, wherein the wrapping unit is used to wrap the expanded structure, so that the crushed cancellous bone fragments are effectively prevented from falling into the extrusion unit and the expanded structure when the bone fixation device is used for reaming in an operation, and thus the expanded structure can be smoothly expanded and contracted in a bone to perform reaming, so as to adjust the reaming direction or the reaming range.

It is still another object of the present invention to provide a bone fixation device, in which the covering unit can effectively control the filling range of the medical filler, thereby preventing the medical filler from flowing into the bone.

It is another object of the present invention to provide a bone fixation device in which a small amount or part of medical filler is oozed out of the pores of the sheathing unit to be integrated with the trabecular bone.

In order to achieve the above-mentioned objectives, the present invention provides a bone fixation device, which includes a pressing unit, a spreading structure, a covering unit, and a fall-back prevention unit.

The extrusion unit comprises a first extrusion piece and a second extrusion piece, wherein the first extrusion piece is provided with a far end and a near end and forms a first shaft hole and at least one first side hole, the first shaft hole penetrates through the near end of the first extrusion piece, the first side hole is communicated with the first shaft hole, the second extrusion piece is movably arranged on the first extrusion piece and is provided with a far end and a near end and forms a second shaft hole and at least one second side hole, and the second shaft hole penetrates through the far end and the near end of the second extrusion piece and is communicated with the first shaft hole and the second side hole.

The unfolding structure is provided with a far end and a near end and forms a plurality of gaps, the far end and the near end of the unfolding structure are respectively arranged on the first extrusion piece and the second extrusion piece, when the second extrusion piece moves towards the far end of the first extrusion piece, the unfolding structure is extruded by the first extrusion piece and the second extrusion piece to be unfolded outwards to an unfolding state, the first side hole is aligned with the second side hole, and the first shaft hole and the second shaft hole are communicated with the gaps of the unfolding structure through the first side hole and the second side hole.

The coating unit is provided with a far end and a near end, the far end and the near end of the coating unit are respectively arranged on the first extrusion piece and the second extrusion piece, and the coating unit coats the unfolding structure, wherein when the unfolding structure is unfolded to the unfolding state, the coating unit is unfolded by the unfolding structure.

The anti-retreat unit is arranged on the extrusion unit, wherein when the unfolding structure is unfolded to the unfolding state, the first extrusion piece selectively limits the second extrusion piece through the anti-retreat unit, so that the second extrusion piece can not move linearly in the direction of the near end of the first extrusion piece, and the unfolding structure is kept in the unfolding state.

Preferably, the anti-moving unit comprises a first anti-moving structure and a second anti-moving structure, the first anti-moving structure is disposed on the first extrusion member, the second anti-moving structure is disposed on the second extrusion member, wherein when the unfolding structure is unfolded to the unfolding state, the first extrusion member selectively limits the second anti-moving structure by the first anti-moving structure to selectively limit the second extrusion member, so that the second extrusion member cannot move linearly in the direction of the proximal end of the first extrusion member, and the unfolding structure is kept in the unfolding state.

Preferably, the first anti-retreat structure is arranged on the inner wall surface of the first shaft hole, the second anti-retreat structure is arranged on the outer wall surface of the second extrusion piece, and the second extrusion piece is arranged in the first shaft hole.

Preferably, the second extrusion member includes a sleeve, a fixing ring and a rod body, the sleeve includes a small diameter section, a sawtooth section and a large diameter section and forms a sleeve shaft hole penetrating through both ends thereof, the proximal end of the unfolding structure is disposed at the small diameter section of the sleeve, the fixing ring is disposed at the sawtooth section of the sleeve and fixes the proximal end of the wrapping unit, the rod body includes a small diameter section and a large diameter section, the small diameter section of the rod body has a distal end and a proximal end, the large diameter section of the rod body has a distal end and a proximal end, the proximal end of the small diameter section of the rod body is combined with the distal end of the large diameter section of the rod body, the small diameter section of the rod body penetrates the sleeve and forms the second side hole, the outer diameter of the large diameter section of the rod body is equal to the outer diameter of the large diameter section of the sleeve, so that the distal end of the large diameter section of the rod body abuts against the large diameter section of the sleeve, the rod body forms the second shaft hole, the second shaft hole penetrates the distal end of the small diameter section of the rod body and the proximal end of the large, the second anti-retreat structure is arranged on the outer wall surface of the small-diameter section of the rod body.

Preferably, the first anti-back-off structure is an internal thread and the second anti-back-off structure is an external thread.

Preferably, the first anti-retreat structure is arranged on the outer wall surface of the first extrusion piece, the first extrusion piece is arranged in the second shaft hole, and the second anti-retreat structure is arranged on the inner wall surface of the second shaft hole.

Preferably, the second extrusion member includes a sleeve, a fixing ring and a rod, the sleeve includes a small diameter section, a sawtooth section and a large diameter section and forms a sleeve shaft hole penetrating through two ends thereof, the proximal end of the unfolding structure is arranged on the small-diameter section of the sleeve, the fixing ring is arranged on the sawtooth section of the sleeve and fixes the proximal end of the cladding unit, the rod body comprises a small-diameter section and a large-diameter section, the small-diameter section of the rod body is provided with a far end and a near end, the large diameter section of the rod body is provided with a far end and a near end, the near end of the small diameter section of the rod body is combined with the far end of the large diameter section of the rod body, the small-diameter section of the rod body penetrates through the shaft hole of the sleeve and forms the second side hole, the outer diameter of the large-diameter section of the rod body is equal to that of the large-diameter section of the sleeve, so that the far end of the large-diameter section of the rod body is abutted against the large-diameter section of the sleeve, the rod body forms the second shaft hole, and the second shaft hole penetrates through the far end of the small-diameter section of the rod body and the near end of the large-diameter section of the rod body.

Preferably, the second shaft hole includes a small diameter section, a polygonal hole section and a threaded section, the small diameter section of the second shaft hole penetrates through the small diameter section of the rod body, the polygonal hole section is located in the large diameter section of the rod body and penetrates through the proximal end of the large diameter section of the rod body, and the threaded section of the second shaft hole is located in the large diameter section of the rod body and is communicated between the small diameter section of the second shaft hole and the polygonal hole section.

Preferably, the bone fixation device further comprises an assisting and deploying unit, wherein the assisting and deploying unit comprises a shell, a manipulating piece, an auxiliary tube and a conduit. The housing has a distal end and a proximal end. The operating member is disposed at the proximal end of the housing. The auxiliary tube is movably arranged on the shell, is provided with a far end and a near end, and forms an insertion hole penetrating through the far end and the near end, the near end of the auxiliary tube is arranged on the control piece, and the far end of the auxiliary tube is polygonal and is embedded in the polygonal hole section of the second shaft hole. The catheter is arranged in the jack of the auxiliary tube and is provided with a far end and a near end, and the far end of the catheter protrudes out of the far end of the auxiliary tube and is screwed in the thread section of the second shaft hole.

Preferably, the deployment assisting unit further comprises a sleeve having a distal end and a proximal end, and forming a through hole penetrating the distal end and the proximal end, the portion of the auxiliary tube exposed out of the housing penetrates the through hole of the sleeve, and the distal end of the auxiliary tube protrudes out of the distal end of the sleeve.

Preferably, the bone fixation device further comprises an injection unit, wherein the injection unit comprises a body, a pushing piece, an extension tube, a sleeve and a conduit. The body has a distal end and a proximal end and contains medical filler therein. The pushing piece is arranged at the near end of the body. The extension tube is provided with a far end and a near end and forms a flow passage, the near end of the extension tube is arranged at the far end of the body, and the flow passage of the extension tube is communicated with the interior of the body. The sleeve has a distal end and a proximal end, and a through hole is formed through the distal end and the proximal end. The catheter is provided with a far end and a near end, the catheter is arranged in the through hole of the sleeve in a penetrating mode, the far end of the catheter protrudes out of the far end of the sleeve and is screwed in the threaded section of the second shaft hole, the near end of the catheter protrudes out of the near end of the sleeve and is arranged at the far end of the extension pipe, and the interior of the catheter is communicated with the flow channel of the extension pipe.

Preferably, the first anti-back-off structure is an external thread and the second anti-back-off structure is an internal thread.

Preferably, the first anti-backup structure includes a plurality of first blocky barbs that are axially arranged in one or more rows, and the second anti-backup structure includes a plurality of second blocky barbs that are axially arranged in one or more rows.

Preferably, the first anti-backup structure includes a plurality of first annular barbs that are axially spaced apart, and the second anti-backup structure includes a plurality of second annular barbs that are axially spaced apart.

Preferably, the first side hole extends around the axis of the first extrusion part towards the proximal end of the first extrusion part to form an inclined hole shape, the second side hole extends around the axis of the second extrusion part towards the distal end of the second extrusion part to form an inclined hole shape, and the extending directions of the first side hole and the second side hole are different.

Preferably, the first side hole is long and extends in a direction parallel to the axis of the first extrusion piece, and the second side hole is long and extends in a direction parallel to the axis of the second extrusion piece.

Preferably, the first extrusion forms a plurality of first side apertures axially aligned in at least one row and in the form of circular apertures, the second extrusion forms a plurality of second side apertures axially aligned in at least one row and in the form of circular apertures.

The anti-retraction unit can prevent the unfolding structure from slightly retracting or completely retracting to the retracted state under the influence of external force when the unfolding structure is in the unfolding state, so that the coating unit is always kept in the state of being stretched by the unfolding structure before the medical filler is filled or in the filling process or before the medical filler is completely filled but is not completely solidified, and the effect of stretching the bone by the bone fixing device is maintained.

Drawings

Fig. 1a is a perspective view of a first embodiment of the bone fixation device of the present invention.

Fig. 1b is an exploded view of a first embodiment of the bone fixation device of the present invention.

Fig. 1c is a cross-sectional view of a first embodiment of the bone fixation device of the present invention.

Fig. 1d is a schematic illustration of the expanded state of the first four-piece lantern-like expanded configuration of the first embodiment of the bone fixation device of the present invention.

Fig. 1e is a cross-sectional view of the expanded state of the first four-piece lantern-like expanded configuration of the first embodiment of the bone fixation device of the present invention.

Fig. 2a is a schematic view of a second four-piece lantern-like deployed configuration in a collapsed state of the first embodiment of the bone fixation device of the present invention.

Fig. 2b is a schematic illustration of the expanded state of a second four-piece lantern-like expanded configuration of the first embodiment of the bone fixation device of the present invention.

Fig. 2c is a schematic view of the collapsed state of the two-piece lantern-like expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2d is a schematic illustration of the expanded state of the two-piece lantern-like expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2e is a schematic view of the contracted state of the strip-like expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2f is a schematic view of the expanded state of the strip-like expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2g is a schematic view of the expanded state of the gourd shaped strip expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 3a is a schematic view of the first embodiment of the bone fixation device of the present invention further including an assisting deployment unit.

Fig. 3b is a schematic view of a first embodiment of the bone fixation device of the present invention positioned on a vertebra.

Fig. 3c is a schematic view of the first embodiment of the bone fixation device of the present invention controlling the deployment of the deployed configuration.

Fig. 3d is a schematic view of a first embodiment of the bone fixation device of the present invention infused with a medical filler.

Fig. 3e is a schematic view of the first embodiment of the bone fixation device of the present invention with the compression unit, the deployment structure, the covering unit, and the deployment and retraction unit left in the vertebrae after completion of the medical filler infusion.

Fig. 4a is a cross-sectional view of a second embodiment of the bone fixation device of the present invention.

Fig. 4b is a cross-sectional view of a third embodiment of the bone fixation device of the present invention.

Fig. 4c is a side view of a third embodiment of the bone fixation device of the present invention.

Fig. 5a is a perspective view of a fourth embodiment of the bone fixation device of the present invention.

Fig. 5b is a cross-sectional view of a fourth embodiment of the bone fixation device of the present invention.

Fig. 5c is a schematic view of the deployment assistance unit of the fourth embodiment of the bone fixation device of the present invention in combination with a second expression member.

Fig. 5d is a schematic view of the deployment assistance unit of the fourth embodiment of the bone fixation device of the present invention urging the second expression member in a linear advancement.

Fig. 5e is an exploded view of a fifth embodiment of the bone fixation device of the present invention.

Fig. 5f is an exploded view of a sixth embodiment of the bone fixation device of the present invention.

Wherein the reference numerals are as follows:

10 extrusion unit

11 first extrusion

111 distal end

113 near end

115 first shaft hole

117. 117 ', 117' first side hole

13 second extrusion

131 second axle hole

1311 minor diameter section

1313 multiple angle hole section

1315 thread segment

132. 132 ', 132' second side hole

133 sleeve

1331 minor diameter segment

1333 sawtooth segment

1335 major diameter section

1337 Sleeve shaft hole

134 fixed ring

135 bar body

1351 small diameter section

1353 large diameter section

20. 20 ', 20' expanded structure

21. 21' distal end

22. 22' proximal end

23. 23 ', 23' clearance

24. 24 ', 24' sheet body

25 ', 25' slotted hole

26 ', 26' strip

30 cladding Unit

31 distal end

33 proximal end

40 anti-back unit

41. 41 ', 41' first anti-back structure

411' first block barb

411' first annular barb

43. 43 ', 43' second anti-back structure

431' second Block barb

431' second annular barb

50 snap ring

60 assist deployment unit

61 casing

611 distal end

613 near end

62 operating element

63 casing tube

631 distal end

633 proximal end

635 through hole

64 auxiliary tube

641 far end

645 plug hole

65 catheter

651 distal end

653 near the end

70 injection unit

71 body

72 pushing member

73 extension pipe

100 vertebrae

200 medical filler

Detailed Description

The following embodiments of the present invention will be described in more detail with reference to the drawings and the accompanying drawings, so that those skilled in the art can implement the invention after studying the specification.

Referring to fig. 1a to 1c, fig. 1a is a perspective view of a first embodiment of a bone fixation device of the present invention, fig. 1b is an exploded view of the first embodiment of the bone fixation device of the present invention, and fig. 1c is a cross-sectional view of the first embodiment of the bone fixation device of the present invention. The present invention provides a bone fixation device, which comprises an extrusion unit 10, a deployment structure 20, a covering unit 30 and an anti-retreat unit 40.

The pressing unit 10 includes a first pressing member 11 and a second pressing member 13. The first extrusion 11 has a distal end 111 and a proximal end 113, and defines a first axial bore 115 and at least one first side bore 117, the first axial bore 115 passing through the proximal end 113 of the first extrusion 11, the first side bore 117 communicating with the first axial bore 115. Preferably, the first extrusion 11 is cylindrical. Wherein, the first side hole 117 is long hole-shaped and extends in parallel with the axis of the first presser 11. The second extrusion 13 is movably disposed on the first extrusion 11, has a distal end and a proximal end, and defines a second axial bore 131 and at least one second lateral bore 132. A second shaft bore 131 extends through the distal and proximal ends of the second extrusion 13 and communicates with the first shaft bore 115 and the second side bore 132. More specifically, the second extrusion 13 includes a sleeve 133, a fixing ring 134 and a rod 135. The sleeve 133 includes a small diameter section 1331, a saw tooth section 1333 and a large diameter section 1335 and forms a sleeve shaft hole 1337 through both ends thereof. The fixing ring 134 is provided to the serrated section 1333 of the sleeve 133. The shaft 135 includes a small diameter portion 1351 and a large diameter portion 1353, the small diameter portion 1351 of the shaft 135 has a distal end and a proximal end, the large diameter portion 1353 of the shaft 135 has a distal end and a proximal end, the proximal end of the small diameter portion 1351 of the shaft 135 is coupled to the distal end of the large diameter portion 1353 of the shaft 135, the small diameter portion 1351 of the shaft 135 has an outer diameter smaller than that of the sleeve shaft hole 1337, the large diameter portion 1353 of the shaft 135 has an outer diameter equal to that of the large diameter portion 1335 of the sleeve 133, the small diameter portion 1351 of the shaft 135 sequentially passes through the sleeve shaft hole 1337 and the first shaft hole 115, the distal end of the large diameter portion 1353 of the shaft 135 abuts against the large diameter portion 1335 of the sleeve 133, so that the distal end of the small diameter portion 1351 of the shaft 135 is defined as the distal end of the second extrusion 13, the proximal end of the large diameter portion 1353 of the shaft 135 is defined as the proximal end of the second extrusion 13, the shaft 135 forms the second shaft hole 131, and the second shaft hole 131 passes through the distal end of the, the small diameter section 1351 of the rod body 135 forms a second side hole 132, and the second side hole 132 is long and extends parallel to the axis of the second extrusion 13. The second shaft hole 131 includes a small diameter section 1311, a polygonal hole section 1313 and a threaded section 1315, the small diameter section 1311 of the second shaft hole 131 penetrates through the small diameter section 1351 of the rod 135, the polygonal hole section 1313 is located in the large diameter section 1353 of the rod 135 and penetrates through the proximal end of the large diameter section 1353 of the rod 135, and the threaded section 1315 of the second shaft hole 131 is located in the large diameter section 1353 of the rod 135 and is communicated between the small diameter section 1311 and the polygonal hole section 1313 of the second shaft hole 131, as shown in fig. 1 c. Preferably, the polygonal hole 1313 of the second shaft hole 131 is hexagonal, as shown in fig. 1a and 1 b.

The expanded structure 20 has a distal end 21 and a distal end 22, and a plurality of voids 23 are formed. The distal end 21 and the proximal end 22 of the deployment structure 20 are provided on the first and second extrusions 11, 13, respectively. More specifically, the distal end 21 of the expanded structure 20 is fixed to the outer wall surface of the first extrusion 11 near the distal end 111 of the first extrusion 11, and the proximal end 22 of the expanded structure 20 is fixed to the small-diameter section 1331 of the sleeve 133 of the second extrusion 13. The fixing means for fixing the distal end 21 and the proximal end 22 of the expandable structure 20 to the first and second pressing members 11, 13 is conventional and therefore not described in detail herein. Referring to fig. 1a, the expandable structure 20 includes four sheets 24, and when the expandable structure 20 is contracted, an elongated gap 23 is formed between each two sheets 24, and each sheet 24 is slightly bent outward at portions near the distal end 21 and the proximal end 22 of the expandable structure 20. Referring to fig. 1d and fig. 1e, fig. 1d is a schematic view showing an unfolded state of a first four-piece lantern-shaped unfolded structure of a first embodiment of the bone fixation device of the present invention, and fig. 1e is a cross-sectional view showing an unfolded state of a first four-piece lantern-shaped unfolded structure of a first embodiment of the bone fixation device of the present invention. When the unfolding structure 20 is unfolded, the sheet bodies 24 are bent outwards and unfolded, and each sheet body 24 has two bending parts, so that the unfolded unfolding structure 20 has a lantern shape, and is called a first four-sheet lantern-shaped unfolding structure. When the second pressing member 13 moves towards the distal end 111 of the first pressing member 11, the unfolding structure 20 is pressed by the first and second pressing members 11, 13 to unfold outwards to an unfolded state, the first side hole 117 is aligned with the second side hole 132, so that the first and second shaft holes 115, 131 are communicated with the gap 23 of the unfolding structure 20 through the first and second side holes 117, 132, as shown in fig. 1d and 1 e. As the second extrusion 13 moves in the direction of the proximal end 113 of the first extrusion 11, the deployed structure 20 is released by the first and second extrusions 11, 13 to contract inwardly to a contracted state, as shown in FIGS. 1a and 1 c.

Referring to fig. 2a, fig. 2a is a schematic view of a second four-piece lantern-like deployed structure of the first embodiment of the bone fixation device of the present invention in a collapsed state. The difference between the second four-piece lantern-shaped unfolding structure and the first four-piece lantern-shaped unfolding structure is that, when the unfolding structure 20 'is in a contracted state, the pieces 24' are smooth from end to end without any bending part, so that the gap 23 'between every two pieces 24' is in a slit shape, and each gap 23 'is formed with two slot holes 25', and the width of each slot hole 25 'is greater than that of the corresponding gap 23'. The two slots 25 'just divide the corresponding gap 23' into three sections. Referring to fig. 2b, fig. 2b is a schematic view of a second four-piece lantern-shaped unfolded structure of the first embodiment of the bone fixation device of the present invention in an unfolded state. When the extended structure 20 ' is extended, the blade 24 ' is bent at a location closer to the slot 25 ' of the distal end 21 ' of the extended structure 20 ', such that the second four-piece lantern-like extended structure has a lantern-like appearance that is different from the first four-piece lantern-like extended structure. Referring to fig. 2c, fig. 2c is a schematic view of the two-piece lantern-like deployed structure of the bone fixation device in a collapsed state according to the first embodiment of the present invention. The development structure 20 "comprises two sheets 24", each gap 23 "is formed with a slotted hole 25", the width of the slotted hole 25 "is greater than the width of the corresponding gap 23". The two slots 25 "are located approximately one third of the two spaces 23" near the distal end of the stent 20 ". Referring to fig. 2d, fig. 2d is a schematic view of the expanded state of the two-piece lantern-shaped expanded structure of the first embodiment of the bone fixation device of the present invention. When the unfolding structure 20 "is unfolded, the two sheets 24" are bent at the two slots 25 "to make the unfolded unfolding structure 20" have a lantern shape, so the unfolding structure is called a two-sheet lantern-shaped unfolding structure. Referring to fig. 2e, fig. 2e is a schematic view of the first embodiment of the bone fixation device of the present invention in a contracted state in a strip-like expanded configuration. Deployment structure 20 "'includes four bars 26"'. Referring to fig. 2f, fig. 2f is a schematic view of the expanded state of the strip-shaped expanded structure of the first embodiment of the bone fixation device of the present invention. The bars 26 "'are curved outwardly when the deployment structure 20"' is deployed. Referring to fig. 2g, fig. 2g is a schematic view of the unfolded state of the gourd shaped bar-shaped unfolded structure of the first embodiment of the bone fixing device of the present invention. The four bars 26 "" of the expanded structure 20 "" are made of memory metal, so that the expanded structure 20 "" is the same as the bar-shaped expanded structure 20 '"of fig. 2e when it is contracted, and when the expanded structure 20" "is expanded, the bars 26'" are bent into a gourd shape, so that it is called a gourd-shaped bar-shaped expanded structure. In short, the shape of the unfolding structure is not limited to that disclosed in the specification and the drawings of the present invention, and any unfolding structure with any shape can be unfolded and folded within the scope of the present invention, which is described in the first place.

The covering unit 30 has a distal end 31 and a proximal end 33, the distal end 31 and the proximal end 33 of the covering unit 30 are respectively disposed on the first and second extrusions 11 and 13, and the covering unit 30 covers the unfolding structure 20. The distal end 31 of the covering unit 30 is fixed on the outer wall surface of the distal end 111 of the first extrusion 11 by a retaining ring 50, for details, see taiwan patent publication No. I321467, which is not repeated herein. The proximal end 33 of the covering unit 30 is fixed to the sawtooth section 1333 of the sleeve 133 by the fixing ring 134, for details, see taiwan patent publication No. I419672, which is not repeated herein. However, the means for fixing the distal end 31 and the proximal end 33 of the covering unit 30 to the first and second pressing members 11, 13 is not limited thereto, and any means capable of fixing the distal end 31 and the proximal end 33 of the covering unit 30 to the first and second pressing members 11, 13 is within the scope of the present invention, as will be described in the foregoing. The coating unit 30 may be any conventional coating unit, and for details, refer to page 6 (paragraph 0034) of taiwan patent publication No. 201536248, which is not described herein. For the material of the covering unit 30, please refer to paragraphs [ 0035 ] and [ 0037 ] on pages 6-7 of the specification of taiwan patent publication No. 201536248, which are not described herein. Wherein, when the unfolding structure 20 is unfolded to the unfolded state, the wrapping unit 30 is unfolded by the unfolding structure 20, as shown in fig. 1 e. The covering unit 30 may have any conventional shape such as a cylindrical shape, a conical shape, a spherical shape, a quasi-spherical shape, a gourd-shaped shape, a square shape, and a quasi-square shape when it is expanded.

The anti-retreat unit 40 is provided to the pressing unit 10, wherein when the unfolding structure 20 is unfolded to the unfolding state, the first pressing member 11 selectively restricts the second pressing member 13 by the anti-retreat unit 40, so that the second pressing member 13 cannot move linearly in the direction of the proximal end 113 of the first pressing member 11, and the unfolding structure 20 is kept in the unfolding state. Preferably, the anti-receding unit 40 includes a first anti-receding structure 41 and a second anti-receding structure 43. The first retreat preventing structure 41 is provided to the first presser 11, and the second retreat preventing structure 43 is provided to the second presser 13. When the unfolding structure 20 is unfolded to the unfolding state, the first extrusion 11 selectively restricts the second anti-backing structure 43 through the first anti-backing structure 41 and selectively restricts the second extrusion 13, so that the second extrusion 13 cannot move linearly in the direction of the proximal end 113 of the first extrusion 11, and the unfolding structure 20 is kept in the unfolding state. Preferably, the first anti-receding structure 41 is disposed on the inner wall surface of the first shaft hole 115 and is an internal thread, and the second anti-receding structure 43 is disposed on the outer wall surface of the small-diameter section 1351 of the rod body 135 of the second extrusion member 13 and is an external thread, so that the small-diameter section 1351 of the rod body 135 of the second extrusion member 13 is screwed into the first shaft hole 115.

In other embodiments, the first anti-back-off structure 41 may be disposed on the outer wall surface of the first extrusion 11 and is a male screw, and the second anti-back-off structure 43 may be disposed on the inner wall surface of the small-diameter section 1311 of the second shaft hole 131 of the second extrusion 13 and is a female screw, so that the first extrusion 11 is screwed on the small-diameter section 1311 of the second shaft hole 131.

Referring to fig. 3a, fig. 3a is a schematic view of a bone fixation device according to a first embodiment of the present invention further including an assisting deployment unit. The bone fixation device of the present invention further comprises a deployment assisting unit 60. The deployment assisting unit 60 includes a housing 61, a manipulating member 62, a sleeve 63, an auxiliary tube 64 and a guide tube 65. The housing 61 has a distal end 611 and a proximal end 613. The operating member 62 is provided at the proximal end 613 of the housing 61. The sleeve 63 has a distal end 631 and a proximal end 633, and forms a through hole 635 through the distal end 631 and the proximal end 633. The auxiliary tube 64 is movably disposed in the housing 61, has a distal end 641 and a proximal end, and forms a receptacle 645 extending through the distal end 641 and the proximal end. The proximal end of the auxiliary tube 64 is provided to the operating member 62. The portion of the auxiliary tube 64 exposed out of the housing 61 is inserted into the through hole 635 of the sleeve 63. The distal end 641 of the auxiliary tube 64 protrudes from the distal end 631 of the sleeve 63, is polygonal, and is embedded in the polygonal hole 1313 of the second shaft hole 131. The guide tube 65 is disposed in the receptacle 645 of the auxiliary tube 64 and has a distal end 651 and a proximal end 653. The distal end 651 of the guide tube 65 protrudes from the distal end 641 of the auxiliary tube 64 and is threadedly received in the threaded section 1315 of the second shaft bore 131. Preferably, the proximal end 653 of the catheter tube 65 is threadably coupled to the secondary tube 64

Referring to fig. 3d, fig. 3d is a schematic view of the bone fixation device according to the first embodiment of the present invention with a medical filler poured therein. The bone fixation device of the present invention further comprises an injection unit 70. The injection unit 70 includes a body 71, a pushing member 72, an extension pipe 73, the sleeve 63 and the conduit 65. The body 71 has a distal end and a proximal end, and contains the medical filler 200 therein. The medical filler may be any conventional medical filler, and the detailed content thereof is referred to in pages 7-8 [ 0041 ] of the specification of taiwan patent publication No. 201536248, which is not described herein again. A pushing member 72 is provided at the proximal end of the body 71. The extension tube 73 has a distal end and a proximal end and forms a flow passage. The proximal end of the extension tube 73 is disposed at the distal end of the body 71, and the flow passage of the extension tube 73 communicates with the interior of the body 71. The difference between the sleeve 63 of the injection unit 70 and the sleeve 63 of the deployment assisting unit and the catheter 65 of the injection unit 70 and the catheter 65 of the deployment assisting unit is that the proximal end of the catheter 65 protrudes from the proximal end of the sleeve 63 and is disposed at the distal end of the extension tube 73, and the interior of the catheter 65 is communicated with the flow passage of the extension tube 73. Preferably, the proximal end of the catheter 65 is threadably coupled to the distal end of the extension tube 73.

The manner of use of the first embodiment of the bone fixation device of the present invention as applied to vertebrae will be described below. Referring to fig. 3b to 3e, fig. 3b is a schematic view showing the first embodiment of the bone fixation device of the present invention placed on a vertebra, fig. 3c is a schematic view showing the first embodiment of the bone fixation device of the present invention controlling the deployment of the deployment structure, fig. 3d is a schematic view showing the first embodiment of the bone fixation device of the present invention perfusing a medical filler, and fig. 3e is a schematic view showing the first embodiment of the bone fixation device of the present invention leaving the pressing unit, the deployment structure, the covering unit and the release unit in the vertebra after the completion of the perfusion of the medical filler. First, the combination of the pressing unit 10, the deploying structure 20, the covering unit 30 and the anti-retreat unit 40 is placed in the vertebra 100 through the assisting deploying unit 60, as shown in fig. 3 b. Referring to fig. 3c, the operating member 62 of the assisted deployment unit 60 is rotated to drive the auxiliary tube 64 of the assisted deployment unit 60 and the guide tube 65 to rotate together, and the guide tube 65 drives the second extrusion 13 to rotate relative to the first extrusion 11, so that the second extrusion 13 is screwed to the first extrusion 11 by the second anti-retreat structure 43 and moves toward the distal end 111 of the first extrusion 11. During the movement of the second extrusion 13 in the direction of the distal end 111 of the first extrusion 11, since the first extrusion 11 has been positioned at the deepest position of the vertebra 100, the second extrusion 13 can press the deployment structure 20 together with the first extrusion 11 to be deployed outward to the deployed state, and the sheathing unit 30 is expanded by the deployment structure 20. The second side hole 132 of the small diameter section 1351 of the rod 135 is aligned with the first side hole 117 of the first extrusion 11, so that the first side hole 117 communicates between the second side hole 132 and the gap 23 of the unfolding structure 20. Then, the housing 61, the manipulating member 62 and the auxiliary tube 64 of the deployment assisting unit 60 are removed, and the sleeve 63 and the guide tube 65 are retained. The proximal end of the catheter 65 is threaded onto the distal end of the extension tube 73. The medical filler 200 inside the body 71 is extruded by the extruding member 72, and passes through the extension pipe 73 of the injection unit 70, the guide pipe 65, the second shaft hole 131 of the second extruding member 13, the second side hole 132 of the second extruding member 13, and the first side hole 117 of the first extruding member 11 in this order, and finally gradually fills the range covered by the covering unit 30 after passing through the gap 23 of the deployment structure 20. After the medical filler 200 is solidified, the injection unit 70 is removed, whereby the combination of the pressing unit 10, the deployment structure 20, the sheathing unit 30, and the recession prevention unit 40 of the bone fixation device of the present invention can effectively prop up the vertebra 100, as shown in fig. 3 e.

Wherein, in the using process, because the anti-receding unit 40 is in a screw type (the first anti-receding structure 41 is an internal screw thread and the second anti-receding structure 43 is an external screw thread, or the first anti-receding structure 41 is an external screw thread and the second anti-receding structure 43 is an internal screw thread), the first and second extrusion pieces 11, 13 can control the unfolding and the shrinking of the unfolding structure 20 in a screw manner, accordingly, if the unfolding structure 20 is to be shrunk to the shrinking state from the unfolding state to adjust the unfolding degree of the unfolding structure 20, the second extrusion member 13 can be rotated by the auxiliary expanding unit 60, so that the second extrusion member 13 is screwed on the first anti-receding structure 41 through the second anti-receding structure 43 and moves towards the proximal end 113 of the first extrusion member 11 while rotating, thereby achieving the purpose of adjusting the expanding degree of the expanding structure 20, and enabling the expanding structure 20 to be smoothly expanded and contracted in the vertebra for reaming, thereby adjusting the reaming direction or the reaming range.

Furthermore, during the expansion of the expanded structure 20, a portion of the cancellous bone fragments are crushed, and at this time, the covering unit 30 can effectively prevent the crushed cancellous bone fragments from falling into the pressing unit 10 and the expanded structure 20, so that the expanded structure 20 can be smoothly expanded and contracted in the vertebra 100 for reaming, thereby adjusting the reaming direction or the reaming range.

In addition, the coating unit 30 can effectively control the perfusion range of the medical filler 200, and avoid the medical filler 200 from mixing in the skeleton.

Also, a small amount or part of the medical filler 200 may be oozed out of the pores of the sheathing unit 30 to be integrated with the trabecular bone.

Most importantly, before, during or before the medical filler 200 is poured or completely poured but not completely solidified, since the anti-retreat unit 40 is of a screw type (the first anti-retreat structure 41 is an internal screw and the second anti-retreat structure 43 is an external screw, or the first anti-retreat structure 41 is an external screw and the second anti-retreat structure 43 is an internal screw), the first and second pressing members 11, 13 can be used for controlling the unfolding and the contraction of the unfolding structure 20 in a screw manner. Accordingly, when the expansion structure 20 is influenced by external force to inwardly extrude the first and second extrusion members 11, 13 in the expanded state, the first extrusion member 11 restricts the second anti-retreat structure 43 by the first anti-retreat structure 41 to restrict the second extrusion member 13, so that the second extrusion member 13 cannot move linearly in the direction of the proximal end 113 of the first extrusion member 11, the expansion structure 20 is maintained in the expanded state, and the effect of preventing the expansion structure 20 from slightly contracting or completely retreating to the contracted state is achieved, the expansion structure 20 can expand the covering device 40 all the time, the covering unit 30 is maintained in the state of being expanded by the expansion structure 20 before the medical filler 200 is poured or in the process of being poured or before being completely solidified, and the effect of the combination of the extrusion unit 10, the expansion structure 20, the covering unit 30 and the anti-retreat unit 40 of the bone fixation device of the present invention to support the vertebra 100 is maintained, but also can be maintained until the medical filler 200 is completely solidified. Once the medical filler 200 is solidified, the deployed structure 20 is completely fixed by the solidified medical filler 200 without any possibility of contraction, achieving the effect of supporting the vertebra 100.

Referring to fig. 4a, fig. 4a is a cross-sectional view of a second embodiment of a bone fixation device of the present invention. The second embodiment of the present invention is substantially identical in construction and use to the first embodiment described above, except that the first extrusion 11 defines a plurality of first side apertures 117 'axially aligned in at least one row and in the form of circular holes, and the second extrusion 13 defines a plurality of second side apertures 132' axially aligned in at least one row and in the form of circular holes.

Referring to fig. 4b and 4c, fig. 4b is a cross-sectional view of a third embodiment of the bone fixation device of the present invention, and fig. 4c is a side view of the third embodiment of the bone fixation device of the present invention. The third embodiment of the present invention is constructed and used in substantially the same manner as the first embodiment described above, except that the first extrusion 11 is formed with two first side holes 117 "extending in an oblique hole shape around the axis of the first extrusion 11 in the direction of the proximal end 113 of the first extrusion 11, and the second extrusion 13 is formed with two second side holes 132" extending in an oblique hole shape around the axis of the second extrusion 13 in the direction of the distal end of the second extrusion 13. Wherein, the extending directions of the first and second side holes 117 '', 132 '' are different. In this embodiment, the two first side holes 117 'are located on the same side of the first extrusion 11 and arranged in a row, and the two second side holes 132' are located on the same side of the second extrusion 13 and arranged in a row. In other embodiments, the distance between the first side holes 117 'can be greater or less than the distance shown in fig. 4b and 4c, and the distance between the second side holes 132' can be greater or less than the distance shown in fig. 4b and 4 c. In other embodiments, the first extrusion 11 may form only a single first side hole 117 'and the second extrusion 13 may form only a single second side hole 132'. In other embodiments, the first extrusion 11 may also form more than two first side holes 117 'with inclined holes, the second extrusion 13 may also form more than two second side holes 132' with inclined holes, and the first side holes 117 'and the second side holes 132' may be randomly arranged. An advantage of such an embodiment is that the first and second side apertures 117 ', 132' having alternating directions of extension maintain at least a partial alignment with one another regardless of the rotation of the first and second extrusions 11, 13 to allow the medical filler 200 to pass through the first and second side apertures 117 ', 132' where they correspond.

Referring to fig. 5a and 5b, fig. 5a is a perspective view of a fourth embodiment of the bone fixation device of the present invention, and fig. 5b is a cross-sectional view of the fourth embodiment of the bone fixation device of the present invention. The fourth embodiment of the present invention is generally identical in construction to the first embodiment described above, except that the first anti-backup structure 41 ' is not an internal thread but includes a plurality of first block barbs 411 ' arranged axially in a row, and the second anti-backup structure 43 ' is not an external thread but includes a plurality of second block barbs 431 ' arranged axially in a row, 431 '. Referring to fig. 5c and 5d, fig. 5c is a schematic view showing the deployment assisting unit of the fourth embodiment of the bone fixation device of the present invention combined with the second pressing member, and fig. 5d is a schematic view showing the deployment assisting unit of the fourth embodiment of the bone fixation device of the present invention pushing the second pressing member in a linear advancing manner. In use, the fourth embodiment of the present invention differs from the first embodiment described above in that, since the anti-retreat unit of the fourth embodiment is of the single-row barb block type, that is, the plurality of second block barbs 431 ' of the second anti-retreat structure 43 ' in the single-row arrangement and the plurality of first block barbs 411 ' of the first anti-retreat structure 41 ' in the single-row arrangement are similar in structure to ratchet teeth, the fourth embodiment can be engaged or misaligned with the second block barbs 431 ' by rotating the second pressing member 13. When the first and second block barbs 411 ', 431' are engaged, the operating member 62 of the assisting deployment unit 60 is pushed to advance the auxiliary tube 64 and the guide tube 65 of the assisting deployment unit 60 together in the direction of the distal end 111 of the first extrusion 11, and the guide tube 65 pushes the second extrusion 13 to linearly move in one direction in the direction of the distal end 111 of the first extrusion 11. To adjust the degree of expansion of the stent 20 by contracting the stent 20 of the fourth embodiment from the expanded state to the contracted state, the second pressing member 13 is rotated by the assisting deployment unit 60 to displace the second block barb 431 ' from the first block barb 411 ' and disengage the first block barb 411 ', whereby the second pressing member 13 can be moved straight directly in the direction of the proximal end 113 of the first pressing member 11 to adjust the degree of expansion of the stent 20, and the stent 20 can be expanded smoothly in the vertebra for reaming. When the deployment structure 20 is subjected to an external force in the deployed state to inwardly press the first and second pressing members 11, 13, the first block barbs 411 'catch the second block barbs 431', thereby preventing the deployment structure 20 from slightly contracting or from completely retracting to the contracted state.

Referring to fig. 5e, fig. 5e is an exploded view of a fifth embodiment of the bone fixation device of the present invention. The fifth embodiment of the present invention is substantially the same in construction and use as the fourth embodiment described above, except that the first block barbs 411 'are axially arranged in two rows, as are the second block barbs 431'. This embodiment is advantageous in that the second row of first block barbs 411 'hook over the second row of second block barbs 431' with greater strength against external forces than the fourth embodiment, and further prevents the deployed structure 20 from contracting slightly or even retracting completely to the retracted state when the deployed state is affected by external forces.

Referring to fig. 5f, fig. 5f is an exploded view of a sixth embodiment of the bone fixation device of the present invention. The sixth embodiment of the present invention is substantially the same in structure and use as the fourth embodiment described above, except that the first anti-backup structure 41 'includes a plurality of first annular barbs 411', said first annular barbs 411 'being axially spaced apart, and the second anti-backup structure 43' includes a plurality of second annular barbs 431 ', said second annular barbs 431' being axially spaced apart. This embodiment is advantageous in that the first and second pressers 11, 13 are restricted from unidirectionally controlling the deployment of the deployment structure 20 to prevent the deployment structure 20 from being slightly contracted or completely withdrawn to the contracted state when the deployed state is affected by an external force.

The foregoing is illustrative of the preferred embodiment of the present invention and is not to be construed as limiting thereof, since any modification or variation thereof within the spirit of the invention is intended to be covered thereby.

Claims

1. A bone fixation device, comprising:

the extrusion unit comprises a first extrusion piece and a second extrusion piece, wherein the first extrusion piece is provided with a far end and a near end and is provided with a first shaft hole and at least one first side hole;

the unfolding structure is provided with a far end and a near end and forms a plurality of gaps, the far end and the near end of the unfolding structure are respectively arranged on the first extrusion piece and the second extrusion piece, when the second extrusion piece moves towards the far end of the first extrusion piece, the unfolding structure is extruded by the first extrusion piece and the second extrusion piece to be unfolded outwards to an unfolding state, the first side hole is aligned with the second side hole, and the first shaft hole and the second shaft hole are communicated with the gaps of the unfolding structure through the first side hole and the second side hole;

the coating unit is provided with a far end and a near end, the far end and the near end of the coating unit are respectively arranged on the first extrusion piece and the second extrusion piece, and the coating unit coats the unfolding structure, wherein when the unfolding structure is unfolded to an unfolding state, the coating unit is unfolded by the unfolding structure; and

and the anti-retreat unit is arranged on the extrusion unit, wherein when the unfolding structure is unfolded to the unfolding state, the first extrusion piece selectively limits the second extrusion piece through the anti-retreat unit, so that the second extrusion piece cannot move linearly in the direction of the near end of the first extrusion piece, and the unfolding structure is kept in the unfolding state.

2. The bone fixation device of claim 1, wherein the anti-back-out unit comprises a first anti-back-out structure and a second anti-back-out structure, the first anti-back-out structure is disposed on the first extrusion piece, the second anti-back-out structure is disposed on the second extrusion piece, wherein when the expansion structure is expanded to the expansion state, the first extrusion piece selectively restricts the second anti-back-out structure by the first anti-back-out structure to selectively restrict the second extrusion piece, so that the second extrusion piece cannot move linearly in the direction of the proximal end of the first extrusion piece, and the expansion structure is maintained in the expansion state.

3. The bone fixation device of claim 2, wherein the first anti-back-out feature is provided on an inner wall surface of the first shaft hole, the second anti-back-out feature is provided on an outer wall surface of the second extrusion and the second extrusion is provided in the first shaft hole.

4. The bone fixation device of claim 3, wherein the second extrusion comprises a sleeve, a fixing ring, and a rod, the sleeve comprises a small diameter section, a sawtooth section, and a large diameter section and forms a sleeve axial hole penetrating both ends of the sleeve, the proximal end of the expanded structure is disposed at the small diameter section of the sleeve, the fixing ring is disposed at the sawtooth section of the sleeve and fixes the proximal end of the wrapping unit, the rod comprises a small diameter section and a large diameter section, the small diameter section of the rod has a distal end and a proximal end, the large diameter section of the rod has a distal end and a proximal end, the proximal end of the small diameter section of the rod is combined with the distal end of the large diameter section of the rod, the small diameter section of the rod passes through the sleeve axial hole and forms the second lateral hole, the outer diameter of the large diameter section of the rod is equal to the outer diameter of the large diameter section of the sleeve, so that the distal end of the large diameter section of the rod abuts against the large diameter section of the sleeve, the rod body forms the second shaft hole, the second shaft hole penetrates through the far end of the small-diameter section of the rod body and the near end of the large-diameter section of the rod body, and the second anti-retreat structure is arranged on the outer wall surface of the small-diameter section of the rod body.

5. The bone fixation device of claim 3, wherein the first anti-back-out feature is an internal thread and the second anti-back-out feature is an external thread.

6. The bone fixation device of claim 2, wherein the first anti-backup feature is provided on an outer wall surface of the first extrusion and the first extrusion is provided in the second axial bore, and the second anti-backup feature is provided on an inner wall surface of the second axial bore.

7. The bone fixation device of claim 6, wherein the second extrusion comprises a sleeve, a fixing ring, and a rod, the sleeve comprises a small diameter section, a sawtooth section, and a large diameter section and forms a sleeve axial hole penetrating both ends of the sleeve, the proximal end of the expanded structure is disposed at the small diameter section of the sleeve, the fixing ring is disposed at the sawtooth section of the sleeve and fixes the proximal end of the wrapping unit, the rod comprises a small diameter section and a large diameter section, the small diameter section of the rod has a distal end and a proximal end, the large diameter section of the rod has a distal end and a proximal end, the proximal end of the small diameter section of the rod is combined with the distal end of the large diameter section of the rod, the small diameter section of the rod passes through the sleeve axial hole and forms the second lateral hole, the outer diameter of the large diameter section of the rod is equal to the outer diameter of the large diameter section of the sleeve, so that the distal end of the large diameter section of the rod abuts against the large diameter section of the sleeve, the rod body forms the second shaft hole, and the second shaft hole penetrates through the far end of the small-diameter section of the rod body and the near end of the large-diameter section of the rod body.

8. The bone fixation device of claim 4 or 7, wherein the second axial bore comprises a small diameter section, a polygonal bore section and a threaded section, the small diameter section of the second axial bore extends through the small diameter section of the rod body, the polygonal bore section is located in the large diameter section of the rod body and extends through the proximal end of the large diameter section of the rod body, and the threaded section of the second axial bore is located in the large diameter section of the rod body and is communicated between the small diameter section of the second axial bore and the polygonal bore section.

9. The bone fixation device of claim 8, further comprising an assisting deployment unit, the assisting deployment unit comprising:

a housing having a distal end and a proximal end;

the operating piece is arranged at the near end of the shell;

the auxiliary tube is movably arranged in the shell, is provided with a far end and a near end, and forms an insertion hole penetrating through the far end and the near end; and

the catheter is arranged in the jack of the auxiliary tube and is provided with a far end and a near end, and the far end of the catheter protrudes out of the far end of the auxiliary tube and is screwed in the thread section of the second shaft hole.

10. The bone fixation device of claim 9, wherein the deployment assisting unit further comprises a sleeve having a distal end and a proximal end, and defining a through hole passing through the distal end and the proximal end, wherein the portion of the auxiliary tube exposed out of the housing passes through the through hole of the sleeve, and the distal end of the auxiliary tube protrudes out of the distal end of the sleeve.

11. The bone fixation device of claim 8, further comprising an injection unit, the injection unit comprising:

a body having a distal end and a proximal end and containing medical filler therein;

the pushing piece is arranged at the near end of the body;

the extension tube is provided with a far end and a near end and forms a flow passage, the near end of the extension tube is arranged at the far end of the body, and the flow passage of the extension tube is communicated with the interior of the body;

a sleeve having a distal end and a proximal end and defining a through hole therethrough; and

the guide tube is provided with a far end and a near end, the guide tube is arranged in the through hole of the sleeve in a penetrating mode, the far end of the guide tube protrudes out of the far end of the sleeve and is screwed in the threaded section of the second shaft hole, the near end of the guide tube protrudes out of the near end of the sleeve and is arranged at the far end of the extension tube, and the interior of the guide tube is communicated with the flow channel of the extension tube.

12. The bone fixation device of claim 6, wherein the first anti-back-out feature is external threads and the second anti-back-out feature is internal threads.

13. The bone fixation device of claim 3 or 6, wherein the first anti-backup structure comprises a plurality of first blocky barbs axially arranged in one or more rows, and the second anti-backup structure comprises a plurality of second blocky barbs axially arranged in one or more rows.

14. The bone fixation device as recited in claim 3 or 6, wherein the first anti-backup feature comprises a plurality of first annular barbs that are axially spaced apart, and the second anti-backup feature comprises a plurality of second annular barbs that are axially spaced apart.

15. The bone fixation device of claim 1, wherein the first side aperture extends diagonally around an axis of the first extrusion in a direction toward a proximal end of the first extrusion, and the second side aperture extends diagonally around an axis of the second extrusion in a direction toward a distal end of the second extrusion, wherein the first and second side apertures extend in different directions.

16. The bone fixation device of claim 1, wherein the first side hole is elongated and extends parallel to an axis of the first extrusion, and the second side hole is elongated and extends parallel to an axis of the second extrusion.

17. The bone fixation device of claim 1, wherein the first extrusion defines a plurality of first side apertures axially aligned in at least one row and in the shape of circular holes, and the second extrusion defines a plurality of second side apertures axially aligned in at least one row and in the shape of circular holes.