CN107303199B - bone fixation device - Google Patents

Abstract

A bone fixation device includes an extruding unit, an unfolding structure, a covering unit and an anti-retraction unit. The extruding unit includes first and second extruding parts. When the second extruding part moves toward the direction of the distal end of the first extruding part, the expanded structure is extruded by the first and second extruding parts to expand. The first extruding part The side hole is aligned with the second side hole, so that the first and second shaft holes communicate with the gap of the unfolded structure through the first and second side holes, the cladding unit is stretched by the unfolded structure, and the first extruded part is The retracting unit selectively restricts the second extruding part, so that the second extruding part cannot move linearly toward the proximal end of the first extruding part, so that the expanded structure remains in an expanded state. In this way, the present invention can prevent the expansion structure from shrinking by the anti-retraction unit, so that the covering unit can be expanded.

Description

bone fixation device

technical field

The invention relates to a bone fixation device, in particular to a bone fixation device which has a covering unit and an unfolding structure, and can be deployed by mechanical force to spread out the bone.

Background technique

In the operation of pouring or inserting medical fillers into the bone, the common existing technologies are as follows:

The first type of prior art is to utilize existing mechanical reaming devices (such as U.S. Patents 20110196494, 20110184447, 20100076426, 20070067034, 20060009689, 20050143827, 20220052623, 6354995, 6676665) to produce a reaming hole in the bone. Space, after the reaming is completed, the reaming device is taken out, and then put into the coating unit, and then the operation of pouring or inserting medical fillers is performed. This type of prior art has the following shortcoming: the cancellous bone (cancellous bone) fragments crushed by the existing mechanical reaming device during reaming often fall in the mechanical reaming device, making the mechanical reaming device The device is stuck, so that the reaming components cannot be retracted (restored to the contracted state), causing the entire mechanical reaming device to be stuck in the reaming part and cannot be taken out.

The second type of prior art is to use existing filling-type reaming devices (such as US patents 5,972,015, 6,066,154, 6,235,043, 6,423,083, 6,607,544, 6,623,505, 6,663,647, and 6,716,216) to ream the bone to generate a space in the bone. After the reaming is completed, the reaming device is taken out, and then put into the coating unit, and then the operation of pouring or inserting medical fillers is performed. Since the filling type reaming device mostly puts a balloon into the bone, uses high pressure to pour liquid (such as water) into the balloon (according to different needs, use a variety of balloons), so that the balloon expands to push the bone. Squeeze the cancellous bone in the bone to achieve the purpose of reaming; however, this device/method has many disadvantages, for example: the balloon must be connected with the nozzle (nozzle), so when the liquid is injected under high pressure, it may cause The phenomenon that the balloon falls off from the filling nozzle, and even the balloon may burst.

The third type of existing technology is to directly put the cladding unit into the bone and perfuse the medical filler without pre-expanding the hole, and use the pressure of the medical filler to perfuse the cladding unit to achieve the expansion of the bone Effect. This kind of cladding unit has the effect of reaming device and bone fixation device (such as China Taiwan Patent Publication No. I321467, I392474; U.S. Patent 6248110) when pouring into medical filler, or even abandons cladding unit, directly uses a The perfusion device perfuses the medical filler into the surgical site to enhance the fixation of the surgical site (eg US Patent No. 5,514,137). This type of prior art has the following disadvantages: because the hole is not reamed first, the scope during perfusion cannot be accurately controlled, so that the direction after perfusion may be different from the doctor's original expectation; in addition, it may even occur during perfusion. After the medical filling, it was found that the cladding unit did not fully support the bone, or the medical filling flowed around in the bone, flowed out of the bone, or even the concentration of the slurry medical filling was too thin or the particle size If it is too small, it will not be able to open the bone smoothly when filling the medical filler, thus greatly reducing the original effect.

The fourth type of prior art is to use the existing mechanical reaming device as a bone fixation device (such as US patents 20120071977, 20110046739, 20100069913, 20100217335, 20090234398, 20090005821), and the mechanical reaming device is implanted into the bone, and After the bone is stretched, the perfusion of the medical filling is carried out, so that the medical filling covers the mechanical reaming device, and after the perfusion is completed, the mechanical reaming device and the medical filling are left in the human body together. This type of prior art can produce two kinds of very serious problems because there is no cladding unit:

First: the flow direction of the medical filling cannot be effectively controlled, so that the medical filling may flow around in the bone, and may even flow out of the bone; and

Second: Before the medical filler is perfused, during the perfusion process, or before it is fully perfused but not completely solidified, the existing mechanical reaming device will be affected by external force when it is in the unfolded state, and then shrink inside the bone situation. Once the existing mechanical reaming device shrinks slightly, it will reduce the effect of distracting the bone. In severe cases, it may even return to the retracted state completely. In this way, the existing mechanical reaming device will completely lose the effect of opening the bone.

In order to solve the two problems caused by the fourth type of prior art, the applicant once proposed a bone fixation device (China Taiwan Patent Publication No. I503097), which uses a covering unit to cover the deployment structure of the deployment device, effectively expanding the bone fixation device. Prevent the crushed cancellous bone fragments from falling into the expansion device during the hole, so that the expansion structure of the expansion device can expand and contract in the bone to expand the hole. In addition, when the medical filler is infused, the device can effectively control the perfusion range of the medical filler to prevent the medical filler from running around in the bone. After the perfusion is completed, the medical filler can completely cover the deployment of the expansion device. structure, to avoid the possibility of contraction of the expanded structure of the expanded device. However, the deployment structure of the deployment device of this type of bone fixation device is relatively simple. Since the bone hardness and bone collapse mode of each patient are not completely the same, the deployment structure of this deployment device cannot be used for different patients. Adjust accordingly. Furthermore, it was found during implementation that when this type of bone fixation device is used on patients with relatively high bone hardness, its distraction effect is not as expected.

Therefore, the applicant further developed a bone fixation device (Taiwan Patent Publication No. 201536248), which can not only increase the strength of the deployment unit by setting multiple deployment structures on the deployment unit, but also enable the deployment unit to support the hardness of the bone A harder bone can cope with various bone collapse situations by adjusting the length and arrangement of each unfolded structure, and the effect is better than that of Taiwan Patent Publication No. I503097.

Contents of the invention

The applicant is not complacent because it has developed a technology that can overcome the problems of the previous technology, so it upholds the spirit of excellence and continues to work hard on the production and development of bone fixation devices, and finally develops a bone fixation device that is better than the applicant's previous second-generation bone fixation device. A new generation of better bone fixation devices.

An object of the present invention is to provide a bone fixation device. The extrusion unit squeezes the unfolded structure to make it unfold. After the unfolded structure is unfolded, the anti-retreat unit can prevent the unfolded structure from being slightly contracted or completely retracted when it is affected by an external force in the unfolded state. Contracted state, so that the covering unit is kept in the state of being stretched by the unfolded structure before the medical filler is perfused, during the process of perfusion, or before it is completely perfused but not completely solidified, and the bone fixation device of the present invention is maintained to stretch the bone Effect.

Another object of the present invention is to provide a bone fixation device. The threaded anti-retraction unit can be used by the first and second extruding parts to control the expansion and contraction of the expanded structure in a spiral manner, so that the expanded structure can be smoothly placed in the bone. Expanding and shrinking to carry out hole reaming to adjust the direction of reaming or the size of the reaming range, and also prevent the expanded structure from shrinking slightly or completely returning to the contracted state when the expanded state is affected by external force.

Another object of the present invention is to provide a bone fixation device, when the anti-retraction units of single-row block-shaped barbs are staggered, the first and second extruding parts can be used to control the expansion and contraction of the expanded structure, so that the expanded structure can It can be smoothly deployed in the bone for reaming; when the single row of block-shaped barb-type anti-retraction units are aligned and engaged, it can prevent the expanded structure from shrinking slightly or completely returning to the contracted state when it is affected by external forces in the deployed state .

Another object of the present invention is to provide a bone fixation device. When the multiple rows of block-shaped barb-type anti-retraction units can be engaged in alignment, the strength against external force is stronger, and it can prevent the expanded structure from being subjected to external force in the expanded state. Efficacy of shrinking slightly or fully retreating to a contracted state upon impact.

Another object of the present invention is to provide a bone fixation device. The ring-shaped barb anti-retraction unit can limit the first and second extruded parts to control the expansion of the expansion structure in one direction, so as to prevent the expansion structure from being affected by external forces in the expanded state. Efficacy of contracting slightly or fully returning to the contracted state.

Another object of the present invention is to provide a bone fixation device. When the unfolded structure is in the unfolded state, the medical filler passes through the second shaft hole of the second extruded part, the second side hole of the second extruded part, the second The first side hole of an extruded part and the void of the unfolded structure are then gradually filled with the area covered by the covering unit.

Yet another object of the present invention is to provide a bone fixation device. The first and second side holes with staggered extension directions can keep at least part of them aligned with each other no matter how the first and second extrusion parts rotate, so that medical filling Objects pass through the corresponding places of the first and second side holes.

Another object of the present invention is to provide a bone fixation device, which uses a coating unit to cover the unfolded structure, so that the bone fixation device can effectively prevent crushed cancellous bone fragments from falling on the extrusion unit and In the expanded structure, the expanded structure can be smoothly expanded and contracted in the bone for reaming, so as to adjust the direction of reaming or the size of the reaming range.

Another object of the present invention is to provide a bone fixation device, the coating unit can effectively control the perfusion range of the medical filler, and prevent the medical filler from running around in the bone.

Another object of the present invention is to provide a bone fixation device, in which a small amount or part of the medical filler will seep out from the pores of the covering unit to integrate with the trabecular bone.

In order to achieve the aforesaid purpose, the present invention provides a bone fixation device, which includes a pressing unit, an unfolding structure, a wrapping unit and an anti-retraction unit.

The extruding unit includes a first extruding part and a second extruding part, the first extruding part has a distal end and a proximal end, and forms a first shaft hole and at least one first side hole, the The first shaft hole runs through the proximal end of the first extrusion part, the first side hole communicates with the first shaft hole, the second extrusion part is movably arranged on the first extrusion part, and has a distal end and a proximal end, and form a second shaft hole and at least one second side hole, the second shaft hole runs through the distal end and the proximal end of the second extrusion and is connected with the first shaft hole and the second side hole The holes are connected.

The expanded structure has a distal end and a proximal end and forms a plurality of gaps, the distal end and the proximal end of the expanded structure are respectively arranged on the first and second extruding parts, wherein, when the second extruding part goes to When the direction of the distal end of the first extruding part moves, the expanded structure is extruded by the first and second extruded parts to expand outward to an expanded state, and the first side hole is aligned with the second side hole , making the first and second shaft holes communicate with the gap of the expanded structure through the first and second side holes.

The covering unit has a distal end and a proximal end, the distal end and the proximal end of the covering unit are respectively arranged on the first and second extruded parts and the covering unit covers the expanded structure, wherein, when the When the unfolding structure is unfolded to the unfolded state, the covering unit is stretched by the unfolding structure.

The anti-retraction unit is arranged on the extruding unit, wherein, when the expansion structure is deployed to the unfolded state, the first extruding member selectively restricts the second extruding member by the anti-retreating unit, so that the The second extruding part cannot linearly move toward the proximal end of the first extruding part, so that the expanded structure remains in an expanded state.

Preferably, the anti-retreat unit includes a first anti-retreat structure and a second anti-retreat structure, the first anti-retreat structure is arranged on the first extruded part, and the second anti-retreat structure is arranged on the second extrusion A compression member, wherein, when the expansion structure is deployed to the expanded state, the first extrusion member selectively restricts the second extrusion by the first anti-retraction structure selectively restricting the second anti-retraction structure The pressing part prevents the second extruding part from moving linearly toward the proximal end of the first extruding part, so that the expanded structure remains in an expanded state.

Preferably, the first anti-retreat structure is arranged on the inner wall of the first shaft hole, the second anti-retreat structure is arranged on the outer wall of the second extruded part and the second extruded part is arranged on the first shaft hole.

Preferably, the second extruded part includes a sleeve, a fixed 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 passing through its two ends, The proximal end of the deployment structure is arranged on the small diameter section of the sleeve, the fixing ring is arranged on the serrated section of the sleeve and fixes the proximal end of the covering unit, the rod body includes a small diameter section and a large diameter section, the 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, and the rod body The small-diameter section of the rod body passes 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 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 touches Leaning against the large-diameter section of the sleeve, the rod body forms the second shaft hole, the second shaft hole runs through the distal end of the small-diameter section of the rod body and the proximal end of the large-diameter section of the rod body, and the second anti-retraction structure It is arranged on the outer wall surface of the small-diameter section of the rod body.

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

Preferably, the first anti-retreat structure is arranged on the outer wall of the first extruded part and the first extruded part is arranged on the second shaft hole, and the second anti-retreat structure is arranged on the second shaft hole inner wall.

Preferably, the second extruded part includes a sleeve, a fixed 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 passing through its two ends, The proximal end of the deployment structure is arranged on the small diameter section of the sleeve, the fixing ring is arranged on the serrated section of the sleeve and fixes the proximal end of the covering unit, the rod body includes a small diameter section and a large diameter section, the 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, and the rod body The small-diameter section of the rod body passes 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 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 touches Leaning against the large-diameter section of the sleeve, the rod body forms the second shaft hole, and the second shaft hole passes through the distal end of the small-diameter section of the rod body and the proximal end of the large-diameter section of the rod body.

Preferably, the second shaft hole includes a small-diameter section, a multi-angle hole section and a threaded section, the small-diameter section of the second shaft hole runs through the small-diameter section of the rod body, and the multi-angle hole section is located at the large-diameter section of the rod body And through the proximal end of the large-diameter section of the rod body, the threaded section of the second shaft hole is located in the large-diameter section of the rod body and communicates between the small-diameter section of the second shaft hole and the polygonal hole section.

Preferably, the bone fixation device further includes an assisting deployment unit, and the assisting deployment unit includes a casing, a manipulation member, an auxiliary tube and a guide tube. The housing has a distal end and a proximal end. The manipulating member is arranged at the proximal end of the housing. The auxiliary tube is movably arranged on the casing, has a far end and a proximal end, and forms an insertion hole passing through the far end and the proximal end, the proximal end of the auxiliary tube is arranged on the operating member, and the far end of the auxiliary tube is The end is polygonal and embedded in the polygonal hole section of the second shaft hole. The catheter is arranged in the insertion hole of the auxiliary pipe and has a far end and a proximal end. The far end of the catheter protrudes from the far end of the auxiliary pipe and is screwed on the threaded section of the second shaft hole.

Preferably, the deployment assisting unit further includes a sleeve, the sleeve has a distal end and a proximal end, and forms a through hole passing through the distal end and the proximal end, and the auxiliary tube is exposed through a part of the casing. A through hole of the sleeve is provided, and the distal end of the auxiliary tube protrudes from the distal end of the sleeve.

Preferably, the bone fixation device further includes an injection unit, and the injection unit includes a body, a pushing member, an extension tube, a cannula and a catheter. The main body has a far end and a near end, and a medical filler is installed inside. The pushing piece is arranged at the proximal end of the body. The extension tube has a far end and a near end, and forms a flow channel. The near end of the extension tube is arranged at the far end of the main body, and the flow channel of the extension tube communicates with the inside of the main body. The sleeve has a distal end and a proximal end, and forms a through hole passing through the distal end and the proximal end. The catheter has a distal end and a proximal end, the catheter is passed through the through hole of the sleeve, the distal end of the catheter protrudes from the distal end of the sleeve, and is screwed on the threaded section of the second shaft hole, The proximal end of the conduit protrudes from the proximal end of the sleeve and is arranged on the distal end of the extension tube, and the inside of the conduit communicates with the flow channel of the extension tube.

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

Preferably, the first anti-retreat structure includes a plurality of first block-shaped barbs, and the first block-shaped barbs are axially arranged in one or more rows, and the second anti-retreat structure includes a plurality of second block-shaped barbs barbs, and the second barbs are axially arranged in one or more rows.

Preferably, the first anti-backward structure includes a plurality of first annular barbs, and the first annular barbs are axially arranged at intervals, and the second anti-backward structure includes a plurality of second annular barbs, The second annular barbs are axially spaced apart.

Preferably, the first side hole extends around the axis of the first extruded part toward the proximal end of the first extruded part in the shape of an oblique hole, and the second side hole surrounds the second extruded part The axis extends toward the distal end of the second extruded part to form an oblique hole, wherein the extending directions of the first and second side holes are different.

Preferably, the first side hole is in the shape of a long hole and its extending direction is parallel to the axis of the first extruded part, and the second side hole is in the shape of a long hole and its extending direction is parallel to the axis of the second extruding part.

Preferably, the first extruded part forms a plurality of first side holes, the first side holes are axially arranged in at least one row and is in the shape of a round hole, and the second extruded part forms a plurality of second side holes holes, and the second side holes are axially arranged in at least one row and are in the shape of round holes.

The effect of the present invention is that the anti-retraction unit can prevent the expanded structure from shrinking slightly or completely returning to the contracted state when it is affected by an external force in the expanded state, so that the covering unit can be filled before, during or completely filled with the medical filler. Before it is completely solidified, it remains in the state of being stretched by the unfolded structure, maintaining the effect of the bone fixation device of the present invention to stretch the bone.

Description of drawings

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

Figure 1 b 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 diagram of the deployed state of the first four-piece lantern-shaped deployed structure of the first embodiment of the bone fixation device of the present invention.

Fig. 1e is a cross-sectional view of the deployed state of the first four-piece lantern-shaped deployed structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2a is a schematic diagram of the contracted state of the second four-piece lantern-shaped expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2b is a schematic diagram of the deployed state of the second four-piece lantern-shaped deployed structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2c is a schematic diagram of the contracted state of the two-piece lantern-shaped expanded structure of the first embodiment of the bone fixation device of the present invention.

Fig. 2d is a schematic diagram of the deployed state of the two-piece lantern-shaped deployed structure of the first embodiment of the bone fixation device of the present invention.

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

Fig. 2f is a schematic diagram of the deployed state of the strip-shaped deployed structure of the first embodiment of the bone fixation device of the present invention.

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

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

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

Fig. 3c is a schematic diagram of the first embodiment of the bone fixation device of the present invention controlling the deployment of the deployment structure.

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

Fig. 3e is a schematic diagram of the first embodiment of the bone fixation device of the present invention, after the medical filler is perfused, the extrusion unit, the deployment structure, the covering unit and the retreating unit are placed in the vertebrae.

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 diagram of a fourth embodiment of the bone fixation device of the present invention, in which the assisting deployment unit is combined with the second extruding part.

Fig. 5d is a schematic diagram of the assisting deployment unit of the fourth embodiment of the bone fixation device of the present invention pushing the second extruding member in a straight forward manner.

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 the sixth embodiment of the bone fixation device of the present invention.

Wherein, the reference signs are explained as follows:

10 extrusion unit

11 First extrusion

111 remote

113 proximal

115 First shaft hole

117, 117’, 117” First Side Hole

13 Second extrusion

131 Second shaft hole

1311 Small Path Section

1313 multi-angle hole segment

1315 threaded segment

132, 132’, 132” second side hole

133 sleeve

1331 Small Path Section

1333 Sawtooth segment

1335 large diameter section

1337 Sleeve shaft hole

134 retaining ring

135 rod body

1351 Small Path Section

1353 large diameter section

20, 20’, 20”, 20”’, 20”” Expanded structure

21, 21’ distal

22, 22' Proximal

23, 23’, 23” Clearance

24, 24’, 24” disc body

25’, 25” slotted holes

26”’, 26”” Bars

30 cladding units

31 remote

33 proximal

40 anti-back unit

41, 41’, 41” The first anti-retraction structure

411’ first block barb

411” 1st Ring Barb

43, 43’, 43” second anti-retraction structure

431’ Second block barb

431” Second Ring Barb

50 Buckle

60 Assisted Unfolding Units

61 housing

611 remote

613 proximal

62 controls

63 casing

631 remote

633 near end

635 through holes

64 Auxiliary tube

641 remote

645 jack

65 conduit

651 remote

653 proximal

70 injection unit

71 Ontology

72 pushing pieces

73 extension tube

100 vertebrae

200 Medical Filling

Detailed ways

The implementation of the present invention will be described in more detail below with reference to the drawings and reference numerals, so that those skilled in the art can implement it after studying this specification.

Please refer to Figure 1a to Figure 1c, Figure 1a is a perspective view of the first embodiment of the bone fixation device of the present invention, Figure 1b is an exploded view of the first embodiment of the bone fixation device of the present invention, Figure 1c is a bone fixation device of the present invention Sectional view of a first embodiment of the fixation device. The present invention provides a bone fixation device, which includes an extrusion unit 10 , an unfolding structure 20 , a covering unit 30 and an anti-retraction unit 40 .

The extrusion unit 10 includes a first extrusion part 11 and a second extrusion part 13 . The first extrusion part 11 has a distal end 111 and a proximal end 113, and forms a first shaft hole 115 and at least one first side hole 117, the first shaft hole 115 runs through the proximal end 113 of the first extrusion part 11 , the first side hole 117 communicates with the first shaft hole 115 . Preferably, the first extruded part 11 is cylindrical. Wherein, the first side hole 117 is in the shape of a long hole and extends in a direction parallel to the axis of the first extruded part 11 . The second extrusion part 13 is movably disposed on the first extrusion part 11 , has a distal end and a proximal end, and forms a second shaft hole 131 and at least one second side hole 132 . The second shaft hole 131 passes through the distal end and the proximal end of the second extruding member 13 and communicates with the first shaft hole 115 and the second side hole 132 . More specifically, the second extrusion part 13 includes a sleeve 133 , a fixing ring 134 and a rod 135 . The sleeve 133 includes a small-diameter section 1331 , a serrated section 1333 and a large-diameter section 1335 and forms a sleeve shaft hole 1337 passing through two ends thereof. The fixing ring 134 is disposed on the sawtooth section 1333 of the sleeve 133 . The rod body 135 includes a small diameter section 1351 and a large diameter section 1353, the small diameter section 1351 of the rod body 135 has a distal end and a proximal end, the large diameter section 1353 of the rod body 135 has a distal end and a proximal end, and the small diameter section of the rod body 135 The proximal end of 1351 is combined with the distal end of the large-diameter section 1353 of the rod body 135, the outer diameter of the small-diameter section 1351 of the rod body 135 is smaller than the diameter of the sleeve shaft hole 1337, and the outer diameter of the large-diameter section 1353 of the rod body 135 is equal to that of the sleeve 133. The outer diameter of the large-diameter section 1335, the small-diameter section 1351 of the rod body 135 passes through the sleeve shaft hole 1337 and the first shaft hole 115 in sequence, and the distal end of the large-diameter section 1353 of the rod body 135 is against the large-diameter section of the sleeve 133 1335, so the distal end of the small-diameter section 1351 of the rod body 135 is defined as the distal end of the second extruded part 13, and the proximal end of the large-diameter section 1353 of the rod body 135 is defined as the proximal end of the second extruded part 13, and the rod body 135 Form the second shaft hole 131, the second shaft hole 131 runs through the distal end of the small-diameter section 1351 of the rod body 135 and the proximal end of the large-diameter section 1353 of the rod body 135, the small-diameter section 1351 of the rod body 135 forms a second side hole 132, and the second side The hole 132 is in the shape of a long hole and extends in a direction parallel to the axis of the second extruded part 13 . Wherein, the second shaft hole 131 includes a small-diameter section 1311, a multi-angle hole section 1313 and a thread section 1315, the small-diameter section 1311 of the second shaft hole 131 runs through the small-diameter section 1351 of the rod body 135, and the multi-angle hole section 1313 is located at the bottom of the rod body 135. The large-diameter section 1353 runs through the proximal end of the large-diameter section 1353 of the rod body 135. The threaded section 1315 of the second shaft hole 131 is located in the large-diameter section 1353 of the rod body 135 and communicates with the small-diameter section 1311 of the second shaft hole 131 and the polygon. Between hole segments 1313, as shown in Figure 1c. Preferably, the polygonal hole segment 1313 of the second shaft hole 131 is in the shape of a hexagonal hole, as shown in FIG. 1a and FIG. 1b .

The deployment structure 20 has a distal end 21 and a distal end 22 and forms a plurality of gaps 23 . The distal end 21 and the proximal end 22 of the deployment structure 20 are respectively disposed on the first and second extrusion parts 11 , 13 . More specifically, the distal end 21 of the expanded structure 20 is fixed on the outer wall of the first extruded part 11 close to the distal end 111 of the first extruded part 11, and the proximal end 22 of the expanded structure 20 is fixed on the second extruded part 13. The small diameter section 1331 of the sleeve 133. Wherein, the means for fixing the distal end 21 and the proximal end 22 of the unfolded structure 20 to the first and second extruded parts 11 and 13 are existing, so details will not be described here. Referring to Fig. 1a, the expanded structure 20 includes four pieces 24. When the expanded structure 20 shrinks, an elongated space 23 is formed between each two pieces 24, and each piece 24 is near the distal end 21 of the expanded structure 20. And the portion of the proximal end 22 is slightly bent outwards. Please refer to Fig. 1d and Fig. 1e. Fig. 1d is a schematic diagram of the expanded state of the first four-piece lantern-shaped unfolded structure of the first embodiment of the bone fixation device of the present invention, and Fig. 1e is the first embodiment of the bone fixation device of the present invention. A cross-sectional view of the unfolded state of the first four-piece lantern-shaped unfolded structure of an embodiment. When the unfolding structure 20 is unfolded, the sheet body 24 is bent and unfolded outward, and each sheet body 24 has two bending places, so that the appearance of the unfolding structure 20 after unfolding presents a lantern shape, so it is called the first A four-piece lantern-like unfolded structure. Wherein, when the second extruding member 13 moves toward the direction of the distal end 111 of the first extruding member 11, the expanded structure 20 is extruded by the first and second extruding members 11, 13 to expand outward to an expanded state , the first side hole 117 is aligned with the second side hole 132, so that the first and second shaft holes 115, 131 communicate with the gap 23 of the unfolded structure 20 through the first and second side holes 117, 132, as shown in Figure 1d and Figure 1e shows. When the second extruding member 13 moves toward the proximal end 113 of the first extruding member 11, the expanded structure 20 is released by the first and second extruding members 11, 13 and contracts inwardly to a contracted state, as shown in FIG. 1a and Figure 1c.

Please refer to FIG. 2 a . FIG. 2 a is a schematic diagram of a contracted state of the second four-piece lantern-shaped expanded structure of the first embodiment of the bone fixation device of the present invention. The difference between the second four-piece lantern-shaped unfolded structure and the first four-piece lantern-shaped unfolded structure is that when the unfolded structure 20' is in a contracted state, the pieces 24' are smooth from the beginning to the end without any bends. Therefore, the gap 23' between each two pieces 24' is in the shape of a slit, and two slots 25' are formed on each gap 23', and the width of each slot 25' is larger than the corresponding gap 23' width. The two slots 25' just divide the corresponding gap 23' into three sections. Please refer to FIG. 2 b . FIG. 2 b is a schematic diagram of the expanded state of the second four-piece lantern-shaped expanded structure of the first embodiment of the bone fixation device of the present invention. When the unfolded structure 20' is unfolded, the sheet body 24' is bent at the slot 25' closer to the distal end 21' of the unfolded structure 20', so that the appearance of the second four-piece lantern-shaped unfolded structure appears A lantern shape that is different from the first four-piece lantern-shaped unfolded structure. Please refer to FIG. 2c . FIG. 2c is a schematic diagram of the contracted state of the two-piece lantern-shaped expanded structure of the first embodiment of the bone fixation device of the present invention. The unfolded structure 20" includes two pieces 24", and a slot 25" is formed in each gap 23", and the width of the slot 25" is larger than the width of the corresponding gap 23". The position of the two slots 25" is roughly located at the third of the distal end of the two gaps 23" close to the unfolded structure 20". Please refer to Fig. 2d, Fig. 2d is the first embodiment of the bone fixation device of the present invention The schematic diagram of the unfolded state of the two-piece lantern-shaped unfolded structure. When the unfolded structure 20 "is unfolded, the two pieces 24" are bent at the two slots 25", so that the unfolded structure 20" has a lantern appearance Shape, so it is called a two-piece lantern-shaped expansion structure. Please refer to Fig. 2e, Fig. 2e is a schematic diagram of the contracted state of the strip-shaped expansion structure of the first embodiment of the bone fixation device of the present invention. The expansion structure 20"' includes Four strips 26"'. Please refer to FIG. 2f, which 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. When the expanded structure 20"' is expanded, the The strip 26"' is bent outward in an arc shape. Please refer to FIG. 2g, which is a schematic diagram of the expanded state of the gourd-shaped strip-shaped expanded structure of the first embodiment of the bone fixation device of the present invention. This expanded structure The four strips 26"" of 20"" are made of memory-type metal, so when the expanded structure 20"" shrinks, it is the same as the strip-shaped expanded structure 20"' in Figure 2e. When the structure 20"" is unfolded, the strip 26''" will bend into a gourd shape, so it is called a gourd-shaped strip-shaped unfolded structure. In short, the shape of the unfolded structure is not limited to what is disclosed in the description and drawings of the present invention, and any shape of the unfolded structure that can be expanded and contracted is included in the scope of the present invention, which will be described first.

The cladding unit 30 has a distal end 31 and a proximal end 33, the distal end 31 and the proximal end 33 of the cladding unit 30 are respectively arranged on the first and second extrusion parts 11, 13 and the cladding unit 30 is clad and expanded. Structure 20. Wherein, the distal end 31 of the cladding unit 30 is fixed on the outer wall of the distal end 111 of the first extruded part 11 by a buckle 50 . For details, please refer to China Taiwan Patent Publication No. I321467, which will not be repeated here. Wherein, the proximal end 33 of the cladding unit 30 is fixed on the sawtooth section 1333 of the sleeve 133 by the fixing ring 134 . For details, please refer to China Taiwan Patent Publication No. I419672, which will not be repeated here. However, the means for fixing the distal end 31 and the proximal end 33 of the covering unit 30 to the first and second extruded parts 11, 13 are not limited thereto, any The means for fixing 33 on the first and second extruded parts 11, 13 are all included in the scope of the present invention, and will be described first. The cladding unit 30 can be any existing cladding unit. For details, please refer to paragraph [0034] on page 6 of the specification of Taiwan Patent Publication No. 201536248, which will not be repeated here. As for the material of the cladding unit 30 , please refer to paragraphs [0035]-[0037] on pages 6-7 of the specification of Taiwan Patent Publication No. 201536248, which will not be repeated here. Wherein, when the unfolding structure 20 is unfolded to the unfolded state, the cladding unit 30 is stretched by the unfolding structure 20 , as shown in FIG. 1 e . Wherein, when the cladding unit 30 is stretched, it can be any existing shape such as cylindrical, conical, spherical, ball-like, gourd-like, square, or square-like.

The anti-retraction unit 40 is arranged on the extruding unit 10, wherein when the expansion structure 20 is deployed to the unfolded state, the first extruding member 11 selectively restricts the second extruding member 13 by the anti-retreating unit 40, so that the second extruding member 13 The element 13 cannot move linearly toward the proximal end 113 of the first extruding element 11 , so that the unfolding structure 20 remains in the unfolded state. Preferably, the anti-retreat unit 40 includes a first anti-retreat structure 41 and a second anti-retreat structure 43 . The first retreat preventing structure 41 is disposed on the first extruded part 11 , and the second retreat preventing structure 43 is disposed on the second extruded part 13 . Wherein, when the unfolding structure 20 is deployed to the unfolded state, the first extruding member 11 selectively restrains the second extruding member 13 through the first retreat preventing structure 41 selectively restricting the second retreat preventing structure 43 , The second extruding part 13 cannot move linearly toward the proximal end 113 of the first extruding part 11, so that the unfolding structure 20 remains in the unfolded state. Preferably, the first anti-retraction structure 41 is provided on the inner wall of the first shaft hole 115 and is an internal thread, and the second anti-retraction structure 43 is provided on the outer wall of the small-diameter section 1351 of the rod body 135 of the second extruded part 13 and is It is an external thread, whereby the small-diameter section 1351 of the rod body 135 of the second extruded part 13 is screwed into the first shaft hole 115 .

In other embodiments, the first anti-retraction structure 41 can also be provided on the outer wall of the first extruded part 11 and be an external thread, and the second anti-retreat structure 43 can also be provided on the second shaft of the second extruded part 13 The inner wall surface of the small-diameter section 1311 of the hole 131 is an internal thread, whereby the first extruded part 11 is screwed on the small-diameter section 1311 of the second shaft hole 131 .

Please refer to FIG. 3 a . FIG. 3 a is a schematic diagram of the first embodiment of the bone fixation device of the present invention further including an assisting deployment unit. The bone fixation device of the present invention further includes an assisting deployment unit 60 . The assisting deployment unit 60 includes a casing 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 manipulation member 62 is disposed 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 passing through the distal end 631 and the proximal end 633 . The auxiliary tube 64 is movably disposed on the casing 61 , has a distal end 641 and a proximal end, and forms an insertion hole 645 passing through the distal end 641 and the proximal end. The proximal end of the auxiliary tube 64 is disposed on the manipulation member 62 . A portion of the auxiliary tube 64 exposed from the casing 61 is passed through 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 , has a polygonal shape, and is embedded in the polygonal hole segment 1313 of the second shaft hole 131 . The catheter 65 is disposed at the insertion hole 645 of the auxiliary tube 64 and has a distal end 651 and a proximal end 653 . The distal end 651 of the catheter 65 protrudes from the distal end 641 of the auxiliary tube 64 and is screwed on the threaded section 1315 of the second shaft hole 131 . Preferably, the proximal end 653 of the catheter 65 is screwed together with the auxiliary tube 64

Please refer to Fig. 3d, Fig. 3d is a schematic diagram of the first embodiment of the bone fixation device of the present invention perfused with a medical filler. The bone fixation device of the present invention further includes an injection unit 70 . The injection unit 70 includes a body 71 , a pushing member 72 , an extension tube 73 , the cannula 63 and the guide tube 65 . The body 71 has a distal end and a proximal end, and a medical filler 200 is installed inside. Wherein, the medical filler can be any existing medical filler. For details, please refer to paragraph [0041] on pages 7-8 of the specification of Taiwan Patent Publication No. 201536248, which will not be repeated here. The pushing member 72 is disposed at a proximal end of the body 71 . The extension tube 73 has a distal end and a proximal end, and forms a flow channel. The proximal end of the extension tube 73 is disposed at the distal end of the body 71 , and the flow path of the extension tube 73 communicates with the inside of the body 71 . Wherein, the sleeve tube 63 of the injection unit 70 is the same component as the sleeve tube 63 of the assisting deployment unit, and the catheter 65 of the injection unit 70 is the same member as the catheter 65 of the assisting deployment unit. The difference is that the proximal end of the catheter 65 protrudes beyond the The proximal end of the sleeve 63 is arranged on the distal end of the extension tube 73 , and the inside of the conduit 65 communicates with the flow channel of the extension tube 73 . Preferably, the proximal end of the catheter 65 is screwed to the distal end of the extension tube 73 .

The application of the first embodiment of the bone fixation device of the present invention to vertebrae will be described below. Please refer to FIG. 3b to FIG. 3e. FIG. 3b is a schematic diagram of the first embodiment of the bone fixation device of the present invention placed on a vertebra, and FIG. 3d is a schematic diagram of the first embodiment of the bone fixation device of the present invention perfused with medical fillers, and Fig. 3e is a schematic diagram of the first embodiment of the bone fixation device of the present invention after the filling of the medical filler is completed, the extrusion unit, the unfolding structure, the package Schematic diagram of overlying unit and setback unit indwelling in the vertebrae. Firstly, the combination of the extrusion unit 10 , the deployment structure 20 , the covering unit 30 and the anti-retraction unit 40 is placed in the vertebra 100 by assisting the deployment unit 60 , as shown in FIG. 3 b . Please refer to Fig. 3c, rotate the manipulator 62 of the assisting deployment unit 60 to drive the auxiliary tube 64 and the conduit 65 of the assisting deployment unit 60 to rotate together, and the conduit 65 drives the second extruding member 13 to rotate relative to the first extruding member 11 In order to make the second extruding part 13 move toward the direction of the distal end 111 of the first extruding part 11 by the second anti-retraction structure 43 being screwed on the first anti-retreating structure 41 . During the movement of the second extruding part 13 toward the distal end 111 of the first extruding part 11, since the first extruding part 11 has been positioned at the deepest part of the vertebra 100, the second extruding part 13 can cooperate with the first extruding part 11. An extruding member 11 presses the expansion structure 20 to expand outward to the expanded state, and the covering unit 30 is stretched by the expansion structure 20 . The second side hole 132 of the small-diameter section 1351 of the rod body 135 is aligned with the first side hole 117 of the first extruded part 11 , so that the first side hole 117 communicates between the second side hole 132 and the gap 23 of the unfolded structure 20 . Next, the shell 61 , the manipulator 62 and the auxiliary tube 64 of the assisting deployment unit 60 are removed, and the sleeve 63 and the catheter 65 are kept. The proximal end of the catheter 65 is threaded onto the distal end of the extension tube 73 . The medical filler 200 inside the main body 71 is extruded by the pusher 72, and passes through the extension tube 73 of the injection unit 70, the conduit 65, the second shaft hole 131 of the second extrusion member 13, the second extrusion The second side hole 132 of the component 13 and the first side hole 117 of the first extruded part 11 finally pass through the gap 23 of the unfolding structure 20 and then gradually fill the area covered by the covering unit 30 . After the medical filler 200 is solidified, the injection unit 70 is removed, whereby the combination of the extrusion unit 10, the deployment structure 20, the covering unit 30 and the anti-retraction unit 40 of the bone fixation device of the present invention can effectively prop up Vertebrae 100, as shown in Figure 3e.

Wherein, in the process of use, since the anti-retreat unit 40 is threaded (the first anti-retreat structure 41 is an internal thread and the second anti-retreat structure 43 is an external thread, or the first anti-retreat structure 41 is an external thread and the second The anti-retraction structure 43 is an internal thread), which can be used by the first and second extrusion parts 11 and 13 to control the expansion and contraction of the expansion structure 20 in a spiral manner. Accordingly, if the expansion structure 20 is to be contracted from the expanded state to the contracted state , to adjust the degree of expansion of the expansion structure 20, the second extrusion component 13 can be screwed to the first anti-retraction structure 41 through the second anti-retraction structure 43 by assisting the expansion unit 60 to rotate the second extrusion component 13 While rotating, it moves towards the proximal end 113 of the first extruding member 11 to achieve the purpose of adjusting the degree of expansion of the expansion structure 20, so that the expansion structure 20 can be smoothly expanded and contracted in the vertebrae for hole reaming and adjustment. The direction of reaming or the size of the reaming range.

Furthermore, during the unfolding process of the unfolding structure 20, some cancellous bone fragments will be crushed. At this time, the covering unit 30 can effectively prevent the crushed cancellous bone fragments from falling into the extrusion unit 10 and the unfolding structure 20. In this way, the expansion structure 20 can be smoothly expanded and contracted in the vertebra 100 to perform hole reaming, so as to adjust the direction of the hole reaming or the size of the reaming range.

In addition, the covering unit 30 can effectively control the perfusion range of the medical filler 200 to prevent the medical filler 200 from running around in the bone.

Also, a small amount or part of the medical filler 200 will seep out from the pores of the covering unit 30 to integrate with the trabecular bone.

Most importantly, before the medical filler 200 is poured, during the pouring process, or before it is completely poured but not yet completely solidified, since the anti-retreat unit 40 is threaded (the first anti-retreat structure 41 is an internal thread and the second anti-retreat The structure 43 is an external thread, or the first anti-retraction structure 41 is an external thread and the second anti-retraction structure 43 is an internal thread), which can be used for the first and second extrusion parts 11, 13 to control the expansion of the expansion structure 20 in a spiral manner and shrinkage. Accordingly, when the expansion structure 20 is affected by an external force in the expanded state and presses the first and second extrusion parts 11 and 13 inwardly, the first extrusion part 11 restricts the second anti-retraction structure 41 by the first anti-retraction structure 41 . The second extruding part 13 can be restrained by retracting the structure 43, so that the second extruding part 13 cannot move linearly toward the proximal end 113 of the first extruding part 11, so that the unfolding structure 20 remains in the unfolded state, so as to prevent the expansion The effect of the structure 20 shrinking slightly or completely returning to the contracted state, the unfolding structure 20 can stretch the covering device 40 all the way, so that the covering unit 30 can be filled before, during or completely filled with the medical filler 200 However, before it is completely solidified, it remains in the state of being stretched by the unfolded structure 20, maintaining the combination of the extrusion unit 10, the unfolded structure 20, the covering unit 30 and the anti-retraction unit 40 of the bone fixation device of the present invention to support the vertebra 100 The effect can be maintained until the medical filler 200 is completely solidified. Once the medical filler 200 is solidified, the expanded structure 20 is completely fixed by the solidified medical filler 200 without any possibility of contraction, so as to achieve the effect of propping up the vertebra 100 .

Please refer to FIG. 4a, which is a cross-sectional view of a second embodiment of the bone fixation device of the present invention. The structure and usage of the second embodiment of the present invention are substantially the same as those of the first embodiment, the difference is that the first extruded part 11 forms a plurality of first side holes 117 ′, and the first side holes 117 ′ are axially Arranged in at least one row and in the shape of circular holes, the second extruded part 13 forms a plurality of second side holes 132 ′, and the second side holes 132 ′ are axially arranged in at least one row and in the shape of circular holes.

Please refer to FIG. 4b and FIG. 4c. FIG. 4b is a cross-sectional view of the 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 structure and usage of the third embodiment of the present invention are substantially the same as those of the first embodiment, the difference is that the first extruded part 11 forms two first side holes 117 ″, and the two first side holes 117 ″ surround the first side hole 117 ″. The axis of an extruded part 11 extends toward the proximal end 113 of the first extruded part 11 to form an oblique hole, and the second extruded part 13 forms two second side holes 132 ", and the two second side holes 132 ” extends around the axis of the second extruded member 13 toward the distal end of the second extruded member 13 and is in the shape of a slanted hole. Wherein, the extension 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 extruded part 11 and arranged in a row , the two second side holes 132'' are located on the same side of the second extruded part 13 and arranged in a row. In other embodiments, the distance between the two first side holes 117'' can be compared to that shown in Figure 4b and Figure 4c The distance shown is larger or smaller, and the distance between the two second side holes 132'' can be larger or smaller than the distance shown in Figure 4b and Figure 4c. In other embodiments, the first extrusion part 11 is also Only a single first side hole 117 ″ in the shape of an oblique hole may be formed, and the second extruded part 13 may also only form a single second side hole 132 ″ in the shape of an oblique hole. In other embodiments, the first One extruded part 11 can also form more than two first side holes 117'' in the shape of oblique holes, and the second extruded part 13 can also form more than two second side holes 132'' in the shape of oblique holes , and the first side holes 117'' and the second side holes 132'' can be arranged arbitrarily. The advantage of this type of embodiment is that no matter how the first and second extruded parts 11, 13 rotate, the extending direction The staggered first and second side holes 117 ″, 132 ″ can be kept at least partially aligned with each other, so that the medical filler 200 can pass through the corresponding places of the first and second side holes 117 ″, 132 ″.

Please refer to FIG. 5a and FIG. 5b. FIG. 5a is a perspective view of the 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 structure of the fourth embodiment of the present invention is substantially the same as that of the aforementioned first embodiment, the difference is that the first anti-retraction structure 41' is not an internal thread but includes a plurality of first block-shaped barbs 411', the first block The barbs 411' are axially arranged in a row, and the second anti-retraction structure 43' is not an external thread but includes a plurality of second block-shaped barbs 431', and the second block-shaped barbs 431' are arranged axially in a row. Please refer to Fig. 5c and Fig. 5d, Fig. 5c is a schematic diagram of the assisting deployment unit combined with the second extruding part of the fourth embodiment of the bone fixation device of the present invention, and Fig. 5d is a schematic diagram of the fourth embodiment of the bone fixation device of the present invention Schematic illustration of the assisted deployment unit pushing the second extrusion in a straight forward motion. In use, the difference between the fourth embodiment of the present invention and the aforementioned first embodiment is that, since the anti-retreat unit of the fourth embodiment is a single-row block barb type, that is to say, it presents a single-row arrangement of the second The plurality of second block-shaped barbs 431' of the anti-retraction structure 43' and the plurality of first block-shaped barbs 411' of the first anti-retraction structure 41' arranged in a single row are similar to ratchets in structure, so the first In the fourth embodiment, the second block-shaped barb 431 ′ can be engaged with or staggered with the first block-shaped barb 411 ′ by rotating the second extruding member 13 . When the first and second block-shaped barbs 411', 431' are engaged, the manipulator 62 of the assisting deployment unit 60 is pushed to drive the auxiliary tube 64 and the conduit 65 of the assisting deployment unit 60 to the first extruding part together. 11 advances in the direction of the distal end 111 of the first extrusion part 11 , and the catheter 65 pushes the second extruding part 13 to move linearly in one direction in the direction of the distal end 111 of the first extruding part 11 . If the expansion structure 20 of the fourth embodiment is to be contracted from the expanded state to the contracted state to adjust the expansion degree of the expansion structure 20, the second extrusion part 13 can be rotated by assisting the expansion unit 60 to make the second block The barb 431 ′ is staggered from the first barb 411 ′ and separated from the first barb 411 ′, so that the second extruded part 13 can directly approach the first extruded part 11 The direction of the end 113 is moved in a straight line to achieve the purpose of adjusting the degree of expansion of the expansion structure 20, so that the expansion structure 20 can be smoothly expanded in the vertebrae for hole reaming. When the unfolding structure 20 is affected by an external force and presses the first and second extrusion parts 11 and 13 inwardly, the first block-shaped barb 411 ′ hooks the second block-shaped barb 431 ′, The effect of preventing the expanded structure 20 from shrinking slightly or completely returning to the contracted state is achieved.

Please refer to FIG. 5e , which is an exploded view of a fifth embodiment of the bone fixation device of the present invention. The structure and usage of the fifth embodiment of the present invention are substantially the same as those of the fourth embodiment, the difference is that the first block-shaped barbs 411 ′ are axially arranged in two rows, and the second block-shaped barbs 431' are also axially arranged in two rows. The advantage of this embodiment is that, compared with the fourth embodiment, when the two rows of first block-shaped barbs 411' catch the two rows of second block-shaped barbs 431', the strength against external force is stronger, and it is more able to prevent unfolding. The structure 20 shrinks slightly when the expanded state is affected by an external force, or even completely returns to the contracted state.

Please refer to FIG. 5f, which is an exploded view of a sixth embodiment of the bone fixation device of the present invention. The structure and usage of the sixth embodiment of the present invention are substantially the same as those of the fourth embodiment, the difference is that the first anti-retraction structure 41'' includes a plurality of first ring-shaped barbs 411'', and the first ring The barbs 411 ″ are axially arranged at intervals, and the second anti-retraction structure 43 ″ includes a plurality of second annular barbs 431 ″, and the second annular barbs 431 ″ are arranged at intervals in the axial direction. The advantage of this embodiment is that it can limit the first and second extruding members 11, 13 to unidirectionally control the expansion of the expansion structure 20, so as to prevent the expansion structure 20 from contracting slightly or completely returning to the contracted state when the expanded state is affected by an external force .

The above descriptions are only preferred embodiments for explaining the present invention, and are not intended to limit the present invention in any form. Therefore, any modification or change of the present invention made under the same creative spirit will be accepted. Still should be included in the category that the present invention intends to protect.

Claims (17)

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.