Osteo-implant

This application claims the priority benefit of Taiwan application serial no. 105143553, filed on Dec. 28, 2016. The entirety of the above-mentioned patent application is hereby incorporated by reference herein and made a part of this specification.

The technical field relates to an implant, and in particular, to an osteo-implant.

When a bone screw or an artificial dental implant is planted in an organism, pressure may be imposed on a surrounding tissue, causing different influences. In recent years, parameterization is used to design the bone screw or the artificial dental implant, and in combination with the finite element method, the optimized bone screw or artificial dental implant is desired to be obtained. As the optimized design may be obtained only if all the possible parameters are designed with this method, and in this process, too much time is spent. However, a bone condition and a bite force of an alveolar bone of different patients are all not the same, an unfit bone screw or artificial dental implant may largely reduce the bone integration ratio, and then derives a higher rate of surgical failure, and further increases the patients' burden.

If, in a mode of matching the human bone growth, a bone screw or an artificial dental implant, which may be directly applied to all sizes, bones or bite forces of the alveolar bone, is designed, the abundant time needed by a parameterization design may be avoided, and the bone screw or the artificial dental implant fitting the patient is obtained, which may enhance the bone integration ratio effectively, to improve the success rate of tooth implantation surgery, and further reduce the patient's burden.

An osteo-implant of the present disclosure has a fixing segment and an implant end. The fixing segment is provided with a thread and at least one bone healing chamber. The bone healing chamber is located at a thread root of the thread. The bone healing chamber is a chamber inwardly depressed from a surface of the fixing segment. The fixing segment has a central axis. In the same segment of the fixing segment, an area of a section, which is parallel to and passes through the central axis, of the at least one bone healing chamber closer to the implant end is smaller.

Based on the above, a section area of a bone healing chamber of the osteo-implant of the present disclosure decreases gradually towards the implant end. This design may accelerate a bone healing rate.

In order to make the above features and advantages of the present disclosure more comprehensible, detailed description is given below with embodiments and with reference to the accompanying drawings.

FIG. 1A is a three-dimensional view of an osteo-implant in accordance with an embodiment of the present disclosure and a local section enlarge view thereof;

FIG. 1B is a local sectional view of the osteo-implant of FIG. 1A ;

FIG. 2A is a three-dimensional view of an osteo-implant in accordance with an embodiment of the present disclosure and a local section enlarged view thereof;

FIG. 2B is a local sectional view of the osteo-implant of FIG. 2A ;

FIG. 3A is a three-dimensional view of an osteo-implant in accordance with another embodiment of the present disclosure;

FIG. 3B is a local enlarged view of the osteo-implant of FIG. 3A ;

FIG. 4A is a local enlarged view of an osteo-implant in accordance with a yet another embodiment of the present disclosure;

FIG. 4B is a local sectional view of the osteo-implant of FIG. 4A ;

FIG. 5 and FIG. 6 are slice photos of an osteo-implant after an animal test in accordance with an embodiment of the present disclosure;

FIG. 7 is a three-dimensional view of an osteo-implant in accordance with another embodiment of the present disclosure and a local section enlarged view thereof; and

FIG. 8 is a three-dimensional view of an osteo-implant in accordance with a yet another embodiment of the present disclosure and a local section enlarged view thereof.

Bone growth requires a proper stress, and an excessive one and an insufficient one both have bad influences. When an osteo-implant is implanted into a bone tissue, the bone tissue may produce different reactions according to different forces. When the bone bears a relatively less force, part of a trabecular bone and an inner compact bone may be removed to decrease the bone strength. When the bone bears a slightly greater force, the bone strength may be promoted. When the force borne by the bone is greater and slightly exceeds the load, the bone may be recovered healthily. When the force borne by the bone exceeds the load far, the bone may be destroyed and cannot be repaired. According to the above principles, the inventor analyzes and calculates whether each space unit fits the bone growth. A space unit fitting the bone growth may be set as a chamber left for the bone growth, and a space unit not fitting the bone growth is then set to be occupied by the osteo-implant. By the above design process, a proper shape of the osteo-implant is finally obtained. A space occupied by the material of the osteo-implant is included, for ensuring enough supporting strength, and also includes at least one bone healing chamber for recovery and growth of the bone tissue. Therefore, the inventor acquires a proper shape of the osteo-implant combining a bone ingrowth proportion and a surrounding healthy bone proportion. Several embodiments of the osteo-implant of the present disclosure are described with reference to the drawings in the following.

FIG. 1A is a three-dimensional view of an osteo-implant in accordance with an embodiment of the present disclosure and a local section enlarge view thereof. Referring to FIG. 1A , the osteo-implant 100 of this embodiment has a fixing segment 110 and an implant end 120 . The fixing segment 110 is provided with a thread 112 and at least one bone healing chamber 114 . The bone healing chamber 114 is located at a thread root 112 A of the thread 112 . The thread 112 of this embodiment is a ridge structure of single strip, inclined to surround a surface 116 of the fixing segment 110 , to enable the fixing segment 110 to be tightly bonded with the bone. However, in other embodiments, the thread may be a ridge structure of multiple strips, inclined to surround the surface of the fixing segment and parallel to each other, the thread may also be multiple closed ring-like ridge structures surrounding the surface of the fixing segment, or the thread may also be other structures that may tightly bond the fixing segment with the bone. The bone healing chamber 114 of this embodiment is in the form of a single strip, and is located at the thread root 112 A of the thread 112 in a way of being parallel to the thread 112 and inclined to surround the surface 116 of the fixing segment 110 . However, in other embodiments, there may also be multiple bone healing chambers 114 . In addition, the bone healing chambers 114 , after being added up, is, for example, substantially similar to, for example, the bone healing chamber 114 of FIG. 1A , but the bone healing chambers 114 may be separated from each other.

The bone healing chamber 114 is a chamber inwardly depressed from the surface 116 of the fixing segment 110 . For example, in a separation manner, the fixing segment 110 may be divided into a columnar body 110 A and the thread 112 . The surface of the columnar body 110 A is the surface 116 of the fixing segment 110 , the thread 112 surrounds the surface 116 of the columnar body 110 , and the thread root 112 A is also located on the surface of the columnar body 110 A. If the bone healing chamber 114 has not been formed, the original position of the surface 116 of the columnar body 110 A may be indicated by a dash line of FIG. 1A . A chamber formed by depressing from the position indicated by the dash line of FIG. 1A to the interior of the osteo-implant 100 is the bone healing chamber 114 . Compared with a conventional osteo-implant with a thread, the osteo-implant 100 of this embodiment has the bone healing chamber 114 depressed at the thread root 112 A of the thread 112 .

The fixing segment 110 has a central axis L 12 , and the central axis L 12 is parallel to the Y axis in FIG. 1A and extends along the axial direction of the columnar body 110 A. If the bone healing chamber 114 is sliced by a section parallel to and passing through the central axis L 12 , many sections of the bone healing chamber 114 may be obtained. In the same segment of the fixing segment 110 , an area of a section of the bone healing chamber 114 closer to the implant end 120 is smaller. From another perspective, the volume of a segment of the bone healing chamber 114 closer to the implant end 120 is smaller. In this embodiment, the same segment indicates that the radius of the fixing segment 110 in the segment does not change drastically. For example, a section 114 A of the bone healing chamber is farthest from the implant end 120 , a section 114 C of the bone healing chamber is closest to the implant end 120 , and the position of a section 114 B of the bone healing chamber is between the section 114 A of the bone healing chamber and the section 114 C of the bone healing chamber. Therefore, the area of the section 114 A of the bone healing chamber is greater than that of the section 114 B of the bone healing chamber, while the area of the section 114 B of the bone healing chamber is greater than that of the section 114 C of the bone healing chamber. As shown by the following Table 1, seven sections of the bone healing chamber 114 in FIG. 1A are numbered from being far from the implant end 120 to being close to the implant end 120 , which are sequentially numbered R 1 -R 7 . If the area of the section 114 A of the bone healing chamber 114 numbered R 1 is 100%, it can be found that the area of the section of the bone healing chamber 114 is indeed smaller when the section is closer to the implant end 120 . The area of the section 114 C of the bone healing chamber which is closest to the implant end 120 and numbered R 7 is merely 59.2% of the area of the section 114 A of the bone healing chamber numbered R 1 .

It is found after experiments that the osteo-implant 100 of this embodiment can combine a bone ingrowth proportion and a surrounding healthy bone proportion, accelerate recovery and reduce surgical failure rates, and then reduce the burden of patients. The improvements of the osteo-implant of the present disclosure in the effect of prompting bone healing as compared with the known art are described in the following with experiment examples.

FIG. 1B is a local sectional view of the osteo-implant of FIG. 1A . Referring to FIG. 1A and FIG. 1B , the fixing segment 110 of the osteo-implant 100 of this embodiment takes a solid design as an example, which may give stronger rigidity to the osteo-implant 100 , but the present disclosure is not limited thereto. Referring to FIG. 1A again, the fixing segment 110 of this embodiment has a central axis L 12 , and the central axis L 12 is parallel to the Y axis in FIG. 1A and extends along the axial direction of the columnar body 110 A. If the bone healing chamber 114 is sliced by a section parallel to and passing through the central axis L 12 , it is obtained that contours of multiple sections of the bone healing chamber 114 each have a vertex angle on a side close to the central axis L 12 . The vertex angle closer to the implant end 120 is greater. For example, when the bone healing chamber 114 is sliced by taking an XY plane as a section through the central axis L 12 , the contour of the section 114 A of the bone healing chamber on the section has a vertex angle A 12 on one side close to the central axis L 12 . Similarly, the section 114 B of the bone healing chamber has a vertex angle A 22 , and the section 114 C of the bone healing chamber has a vertex angle A 32 . The vertex angle A 32 of the section 114 C of the bone healing chamber is greater than the vertex angle A 22 of the section 114 B of the bone healing chamber, and the vertex angle A 22 of the section 114 B of the bone healing chamber is greater than the vertex angle A 12 of the section 114 A of the bone healing chamber. It is found after experiments that, when the vertex angles of the sections of the bone healing chamber 114 are arranged as above, it is possible to combine the bone ingrowth proportion and the surrounding healthy bone proportion, accelerate recovery and reduce surgical failure rates, and then reduce the burden of patients. In addition, the vertex angle of the section of the bone healing chamber 114 farthest from the implant end 120 is an acute angle, that is, the vertex angle A 12 of the section 114 A of the bone healing chamber is an acute angle. The vertex angle of the section of the bone healing chamber 114 closest to the implant end 120 is an obtuse angle, that is, the vertex angle A 32 of the section 114 C of the bone healing chamber is an obtuse angle. In an embodiment, the vertex angle of the section of the bone healing chamber 114 may be between 15° to 160°.

From another perspective, the vertex angle of each section of the bone healing chamber 114 of this embodiment consists of a first edge and a second edge. Multiple angles of the first edges and the central axis L 12 decrease in a range of 5° to 45° in a direction from being away from the implant end 120 towards being close to the implant end 120 . Multiple angles of the second second edges and the central axis L 12 decrease in a range of 5° to 120° in a direction from being away from the implant end 120 towards being close to the implant end 120 . Specifically, the vertex angle Al 2 of the section 114 A of the bone healing chamber 114 consists of a first edge E 12 and a second edge E 14 , the vertex angle A 22 of the section 114 B of the bone healing chamber 114 consists of a first edge E 22 and a second edge E 24 , and the vertex angle A 32 of the section 114 C of the bone healing chamber 114 consists of a first edge E 32 and a second edge E 34 .

In FIG. 1A , to ease the description about angles between the central axis L 12 and two sides of the vertex angle, the central axis L 12 is translated to pass through the position of each vertex of vertex angle. In two sides of each vertex angle, one side closer to the positive Y axis direction (i.e., the direction of the central axis L 12 away from the implant end 120 ) is the first edge, and the other side is taken as the second edge. An included angle A 14 between the first edge E 12 of the vertex angle Al 2 of the section 114 A of the bone healing chamber 114 and the central axis L 12 refers to an angle in the case of anticlockwise rotation from the first edge E 12 to the central axis L 12 . An included angle A 24 between the first edge E 22 of the vertex angle A 22 of the section 114 B of the bone healing chamber 114 and the central axis L 12 refers to an angle in the case of anticlockwise rotation from the first edge E 22 to the central axis L 12 . An included angle A 34 between the first edge E 32 of the vertex angle A 32 of the section 114 C of the bone healing chamber 114 and the central axis L 12 refers to an angle in the case of anticlockwise rotation from the first edge E 32 to the central axis L 12 . The included angle A 14 between the first edge E 12 and the central axis L 12 is greater than the included angle A 24 between the first edge E 22 and the central axis L 12 , and the included angle A 24 between the first edge E 22 and the central axis L 12 is greater than the included angle A 34 between the first edge E 32 and the central axis L 12 . In an embodiment, the included angle A 14 between the first edge E 12 and the central axis L 12 is 45° , and the included angle A 34 between the first edge E 32 and the central axis L 12 is 5° . In addition, multiple included angles (including, but not limited to, the included angles A 14 , A 24 , and A 34 ) between the first edges (including, but not limited to, the first edges E 12 , E 22 and E 32 ) and the central axis L 12 may range from 5° to 45° .

An included angle A 16 between the second edge E 14 of the vertex angle A 12 of the section 114 A of the bone healing chamber 114 and the central axis L 12 refers to an angle in the case of clockwise rotation from the second sidesecond edge E 14 to the central axis L 12 . An included angle A 26 between the second edge E 24 of the vertex angle A 22 of the section 114 B of the bone healing chamber 114 and the central axis L 12 refers to an angle in the case of clockwise rotation from the second edge E 24 to the central axis L 12 . An included angle A 36 between the second edge E 34 of the vertex angle A 32 of the section 114 C of the bone healing chamber 114 and the central axis L 12 refers to an angle in the case of clockwise rotation from the second edge E 34 to the central axis L 12 . The included angle A 16 between the second edge E 14 and the central axis L 12 is greater than the included angle A 26 between the second edge E 24 and the central axis L 12 , and the included angle A 26 between the second edge E 24 and the central axis L 12 is greater than the included angle A 36 between the second edge E 34 and the central axis L 12 . In an embodiment, the included angle A 16 between the second edge E 14 and the central axis L 12 is 120° , and the included angle A 36 between the second edge E 34 and the central axis L 12 is 15° . In addition, multiple included angles (including, but not limited to, the included angles A 16 , A 26 , and A 36 ) between the second edges (including, but not limited to, the second edges E 14 , E 24 and E 34 ) and the central axis L 12 may range from 15° to 120° .

The osteo-implant 100 of this embodiment may manufacture an integrally formed structure by an additive manufacturing method, for example, a 3D printing technology, but the present disclosure is not limited thereto.

FIG. 2A is a three-dimensional view of an osteo-implant in accordance with an embodiment of the present disclosure and a local section enlarged view thereof, and FIG. 2B is a local sectional view of the osteo-implant of FIG. 2A . Referring to FIG. 2A and FIG. 2B , the fixing segment 210 of the osteo-implant of this embodiment comprises a first segment 210 A and a second segment 210 B which is located between the first segment 210 A and an implant end 220 . The first segment 210 A is solid and the second segment 210 B is hollow. An outer wall of the second segment 210 B has a thickness of above 100 μm, which can maintain proper strength. The volume of the hollow part of the second segment 210 B, for example, may account for below 60% of the entire volume of the second segment 210 B, but the present disclosure is limited thereto. As described in the previous embodiment, in the same segment of the fixing segment 210 , the area of the section of the bone healing chamber 114 closer to the implant end 220 is smaller. As shown by the following Table 2, seven sections of the bone healing chamber 214 in FIG. 2A are numbered from being away from the implant end 220 to being closed to the implant end 220 , sequentially numbered R 1 -R 7 . If the area of the section 214 A of the bone healing chamber 214 numbered R 1 is 100%, it can be found that the area of the first section 210 A of the bone healing chamber 214 of this embodiment is smaller when the section is closer to the implant end 220 . In addition, the area of the second section 210 B of the bone healing chamber 214 of this embodiment is also smaller when the section is closer to the implant end 220 . However, the area of the section of the bone healing chamber 214 which is closest to the implant end 220 in the first segment 210 A and numbered R 3 is less than the area of the section of the bone healing chamber 214 which is farthest from the implant end 220 in the second segment 210 B and numbered R 4 . In an embodiment, the area of the section of the bone healing chamber 214 numbered R 4 is also greater than the area of the section of the bone healing chamber 214 which is farthest from the implant end 220 in the first segment 210 A and numbered R 1 , the hollow second segment 210 B may provide an environment suitable for the growth of the bone tissue, so that the area of the section of the bone healing chamber 214 of the second segment 210 B is relatively bigger.

FIG. 3A is a three-dimensional view of an osteo-implant in accordance with another embodiment of the present disclosure; FIG. 3B is a local enlarged view of the osteo-implant of FIG. 3A . The osteo-implant 300 of FIG. 3A is similar to the osteo-implant 200 of FIG. 2A , and the similarity is not repeated here. A first segment 310 A of the osteo-implant of FIG. 3A is solid, and a second segment 310 B of the osteo-implant 300 is hollow and has a central chamber C 30 as shown by the dash line. The bone healing chamber 314 is at least partially connected to the central chamber C 30 , for example, a part of the second segment 310 B of the bone healing chamber 314 located in the osteo-implant 300 is in communication with the central chamber C 30 . In this embodiment, the bone healing chamber 314 of the second segment 310 B has multiple pores P 30 , to be in communication with the central chamber C 30 . In an embodiment, the section area of a single pore P 30 is between 2500 μm 2 and 90000 μm 2 , but the present disclosure is not limited thereto. As shown in the following Table 3 , seven sections of the bone healing chamber 314 of FIG. 3A is numbered from being away from the implant end 320 to being close to the implant end 320 , sequentially numbered R 1 -R 7 . The area of the section of the bone healing chamber 314 numbered R 1 is 100%, and it can be found that the area of the section, closer to the implant end 320 , of the bone healing chamber 314 of the first segment 310 A of the fixing segment 310 of this embodiment is smaller. In addition, the area of the section, closer to the implant end 320 , of the bone healing chamber 314 of the second segment 310 B of the fixing segment 310 is also smaller. However, the area of the section of the bone healing chamber 314 which is closest to the implant 320 and numbered R 3 in the sections of the bone healing chamber 314 of the first segment 310 A is smaller than the area of the section of the bone healing chamber 314 which is farthest from the implant 320 and numbered R 4 in the sections of the bone healing chamber 314 of the second segment 310 B. The design that the bone healing chamber 314 is in communication with the central chamber C 30 may increase the bone ingrowth proportion.

FIG. 4A is a local enlarged view of an osteo-implant in accordance with a yet another embodiment of the present disclosure, and FIG. 4B is a local section view of the osteo-implant of FIG. 4A . The osteo-implant 400 of FIG. 4A is similar to the osteo-implant 300 of FIG. 3A , and the similarity is not repeated here. A fixing segment 410 of the osteo-implant 400 of this embodiment comprises a first segment 410 A and a second segment 410 B, and the second 410 B is located between the first segment 410 A and the implant end 420 . The first segment 410 A and the second segment 410 B are both hollow, but the radius of the first segment 410 A is different from that of the second segment 410 B. In an embodiment, the radius of the second segment 410 B is 30%-99% of the radius of the first segment 410 A. The areas of the sections of the bone healing chamber 414 still conform to the decreasing rule to gradually decrease from being away from the implant end 420 to being close to the implant end 420 , and the lowest layer has hardly any chamber. In addition, a part of the bone healing chamber 414 is in communication with a central chamber C 40 via a pore P 40 .

FIG. 5 and FIG. 6 are slice photos of an osteo-implant after an animal test in accordance with an embodiment of the present disclosure. The design of the osteo-implant of FIG. 5 and FIG. 6 is substantially similar to that of the osteo-implant of FIG. 4A . The inventor implants an osteo-implant of an experiment example of the present disclosure into an animal body, and observes a situation where the osteo-implant prompts generation of bone tissues. In the first month, traces of new bones are attached to the surface of the osteo-implant of this embodiment, and meanwhile, traces of bones enter the central chamber. In the second month, it is visible that the new bones grow around the osteo-implant and in the bone healing chamber, to increase stability thereof, as the horizontal section of FIG. 5 and the vertical section of FIG. 6 . The interior and the surface of the osteo-implant of this embodiment are both covered by new bones, and new bone tissues fit closely to the surface of the osteo-implant. In one month of the implant, the bone mass density (BMD) of the conventional osteo-implant is 0.88±0.48, while the BMD of the osteo-implant of the experiment example can reach 1.14±0.48. The bone volume ratio (BV/TV) of the conventional osteo-implant is about 66.79%, while the BV/TV of the osteo-implant of the experiment example can reach 85.15%. The bone surface density of the conventional osteo-implant is about 6.47/unit area, while the bone surface density of the osteo-implant of the experiment example can reach 7.25/unit area. In addition, the performance of the experiment that uses the osteo-implant of the experiment example in a torsion test after two-month implant is superior to the experiment that uses the conventional osteo-implant. Thus, it can prove that the osteo-implant of the present disclosure has a good bone healing rate.

The osteo-implants of the above embodiments are applied to gums, but the present disclosure is not limited thereto.

FIG. 7 is a three-dimensional view of an osteo-implant in accordance with another embodiment of the present disclosure and a local section enlarged view thereof. Referring to FIG. 7 , the osteo-implant 500 of this embodiment is similar to the osteo-implant 100 of FIG. 1A , and the similarities are not repeated herein. The osteo-implant 500 of FIG. 7 is applied to pedicle screw fixation, and areas of sections of a bone healing chamber 514 of a fixing segment 510 are also smaller when the sections are closer to an implant end 520 . As shown by the following Table 4, thirteen sections of the bone healing chamber 514 in FIG. 7 are numbered from being away from the implant end 520 to being close to the implant end 520 , sequentially numbered R 1 -R 13 . If the area of the section of the bone healing chamber 514 numbered R 1 is 100%, it can be found that the areas of the sections of the bone healing chamber 514 are smaller when the sections are closer to the implant end 520 .

FIG. 8 is a three-dimensional view of an osteo-implant in accordance with a yet another embodiment of the present disclosure and a local section enlarged view thereof. Referring to FIG. 8 , the osteo-implant 600 of this embodiment is similar to the osteo-implant 100 of FIG. 1A , and the similarities are not repeated herein. The osteo-implant 600 of FIG. 8 is applied to hip joints, and threads of a fixing segment 610 are multiple closed ring-like ridge structures around the surface of the fixing segment 610 , enabling the fixing segment 610 to have multiple bone healing chambers 614 . The closer sections of the multiple bone healing chambers 614 are to the implant end 620 , the smaller the areas thereof are. In FIG. 8 , the original position of the surface 116 of the columnar body of the fixing segment 610 is indicated with dotted lines, chambers inwardly depressed towards the interior of the osteo-implant 600 from the position indicated with dotted lines are bone healing chambers 614 , and areas of sections of the multiple bone healing chambers 614 are also calculated according to the rule. As shown by the following Table 5, six bone healing chambers 614 in FIG. 8 are numbered from being away from the implant end 620 to being close to the implant end 620 , sequentially numbered R 1 -R 6 . If the area of the section of the bone healing chambers 614 numbered R 1 is 100%, it can be found that the areas of the sections of the bone healing chambers 614 are smaller when the sections are closer to the implant end 620 .

In summary, the osteo-implant of the present disclosure has at least one bone healing chamber at a thread root, and areas of sections of the bone healing chambers on the same section gradually decrease towards the implant end. Such a design not only can adjust overall rigidity of the osteo-implant, but also increases the bone integration ratio and accelerates the bone healing speed.

Although the present disclosure has been disclosed as above with embodiments, the embodiments are not used to limit the present disclosure. Any person of ordinary skill in the art can make some changes and modifications without departing from the spirit and scope of the present disclosure, and thus the protection scope of the present disclosure is as defined by the appended claims.