SUPPORTING MEMBER AND SUPPORTING MEMBER ASSEMBLY FOR IMPLANTATION INTO OR BETWEEN SUBJECTS BONES, AND TEMPLATE PLUG AND TAMPER CORRESPONDING TO THE SAME
20210186707 · 2021-06-24
Inventors
Cpc classification
A61F2002/4627
HUMAN NECESSITIES
A61F2002/30331
HUMAN NECESSITIES
A61F2002/30772
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
A61F2002/30616
HUMAN NECESSITIES
A61F2002/448
HUMAN NECESSITIES
A61F2/2846
HUMAN NECESSITIES
A61F2002/4631
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2002/4625
HUMAN NECESSITIES
A61F2002/30329
HUMAN NECESSITIES
A61F2002/4435
HUMAN NECESSITIES
A61B17/8852
HUMAN NECESSITIES
A61F2002/4485
HUMAN NECESSITIES
A61F2002/30471
HUMAN NECESSITIES
A61F2002/4681
HUMAN NECESSITIES
International classification
Abstract
The present invention provides a supporting member and a supporting member assembly including the same to be implanted into or between a subject's bones, and a template plug and a tamper corresponding to the supporting member. The supporting member comprises a main body; a first connecting portion and a second connecting portion formed on the upper and lower sides of the main body respectively and forming a dovetail joint with each other; and a guiding structure formed at a side of the main body and including guiding holes as well as a buffer groove for mating with an external template plug. The supporting members of the invention can be sequentially implanted and connected into a bone or between two connected bones, and improve the defect of the conventional one-size giant implants injuring the surrounding nerves.
Claims
1. A supporting member for implantation into or between a subject's bones, comprising: a main body having two opposite sides defined respectively as an upper side and a lower side; a first connecting portion formed at the upper side of the main body and shaped as a male or female part of a dovetail joint; a second connecting portion formed at the lower side of the main body and corresponding in shape to the first connecting portion; and a guiding structure formed at a side of the main body and configured to mate with an external template plug; wherein the first connecting portion of the supporting member is connectable with the second connecting portion of another said supporting member to form a said dovetail joint.
2. The supporting member of claim 1, wherein the first connecting portion is a dovetail block and the second connecting portion is a dovetail groove in order to prevent two vertically connected said supporting members from separating from each other after connecting in a sliding manner.
3. The supporting member of claim 2, wherein a front side of the first connecting portion further includes a first positioning portion, a front side of the second connecting portion further includes a second positioning portion, and the second positioning portion corresponds in shape and position to the first positioning portion; wherein, the first positioning portion is a positioning block and the second positioning portion is a positioning hole so that the supporting members with such structures are able to position and fasten to each other.
4. The supporting member of claim 1, wherein a front side of the main body has a U-shaped groove structure that can be compressed or deformed to facilitate fastening between supporting members and return to an original shape elastically to prevent the supporting members from separating from each other.
5. The supporting member of claim 1, wherein the guiding structure includes a plurality of guiding holes and/or buffer grooves.
6. The supporting member of claim 5, wherein the guiding holes and the buffer grooves have various designs with progressive deviation or difference in terms of angle, position, size, or shape.
7. The supporting member of claim 1, wherein the main body is one or a plurality of reticulated structures.
8. The supporting member of claim 7, wherein the reticulated structure can be filled with a bone-filling material or bone cement.
9. The supporting member of claim 1, wherein the bone is a vertebra.
10. The supporting member of claim 1, wherein a material of the supporting member includes metal, plastic, or a mixture thereof.
11. A template plug configured to guide the supporting member of claim 1 into or between a subject's bones, which includes a plurality of connecting pins, an extension portion, and a grip portion, wherein the extension portion has one end connected to the plural connecting pins and an opposite end connected to the grip portion, and the extension portion and/or the grip portion has: a third connecting portion, which is formed on an upper side of the extension portion and/or the grip portion, and is a dovetail projection; a fourth connecting portion, which is formed on a lower side of the extension portion and/or the grip portion, and corresponds to the third connecting portion; wherein, the plural connecting pins can be correspondingly engaged with the guiding structure of the supporting member.
12. The template plug of claim 11, wherein the template plug further includes a plurality of connecting pins and buffer bases.
13. The template plug of claim 12, wherein the template plug has two connecting pins that correspond in design to but are slightly different from the guiding structure in terms of angle, position, shape, or size.
14. The template plug of claim 11, wherein the third connecting portion of the template plug can correspond to the second connecting portion of the supporting member and the fourth connecting portion can correspond to the first connecting portion of the supporting member so that the template plug can be pushed along and coupled with the supporting member in a sliding manner.
15. A tamper, which can correspondingly match the supporting member of claim 1 or the template plug of claim 11, the tamper includes a slender shaft and a grip portion connected to the slender shaft; wherein, an upper side of the slender shaft and/or the grip portion further includes a fifth connecting portion corresponding to the second connecting portion, and a lower side of the slender shaft and/or the grip portion further includes a sixth connecting portion corresponding to the first connecting portion.
16. A supporting member assembly to be implanted into or between a subject's bones, which includes a plurality of supporting members of claim 1, wherein the first connecting portion of each supporting member forms a dovetail joint with the second connecting portion of another said supporting member in order to connect the plural supporting members sequentially.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0045] The details and technical solution of the present invention are hereunder described with reference to accompanying drawings. For illustrative sake, the accompanying drawings are not drawn to scale. The accompanying drawings and the scale thereof are not restrictive of the present invention.
[0046] The use of “comprise/include” means not excluding the presence or addition of one or more other components, steps, operations, and/or elements to the described components, steps, operations, and/or elements. As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context dictates otherwise.
[0047] Hereinafter, the present invention will be further described with detailed descriptions and embodiments. However, it should be understood that these embodiments are only used to help understand the invention more easily, not to limit the scope of the invention.
[0048] The present invention is designed not only for implantation into or between human bones, but also for use in other vertebrates such as amphibians, reptiles, birds, and mammals. Furthermore, the invention can be used in or between any suitable bones, preferably but not limited to vertebrae. In one preferred embodiment, the bone to which the invention is applied is a vertebra.
[0049] Generally speaking, a conventional bone implant cannot be minimally invasive and adequately supportive at the same time. To solve the clinical problems associated with bone fracture effectively, the present invention aims to provide a supporting member, a supporting member assembly, a template plug for guiding the supporting member into a subject's bone or between two connected bones, and a tamper for assisting the required implantation operation. A detailed description of some embodiments of the invention is given below.
[Embodiments 1 to 4]—Supporting Member
[0050] Please refer to
[0051] The supporting members 100 according to embodiments 1 to 4 are configured to be implanted into or between a subject's bones and each include a main body 11, a first connecting portion 12, a second connecting portion 13, and a guiding structure 14. The main body 11 has an upper side and a lower side, which is the opposite side of the upper side. In embodiment 3, referring to
[0052] The first connecting portion 12 is formed on the upper side of the main body 11 and is shaped as the male part of a dovetail joint. The second connecting portion 13 is formed in the lower side of the main body 11 and corresponds in shape to the first connecting portion 12. The first connecting portion 12 of a supporting member 100 can be connected to the second connecting portion 13 of another supporting member 100 to form a dovetail joint. As used herein, the term “male (or female) part of a dovetail joint” refers to a trapezoidal structure protruding from (or sunken into) the main body 11, and the term “dovetail joint” refers to a joint formed by such a protruding trapezoidal structure engaged with, fastened to, connected in a sliding manner to, or otherwise secured in a matching sunken trapezoidal structure. In one preferred embodiment, the first connecting portion is a dovetail block, the second connecting portion is a dovetail groove, and the first connecting portion of a supporting member with such connecting portions can form a dovetail joint with the second connecting portion of another such supporting member, as shown in
[0053] In some embodiments, the first connecting portion further includes a first positioning portion, and the second connecting portion further includes a second positioning portion corresponding in shape and position to the first positioning portion. For example, the first positioning portion may be a protruding structure while the second positioning portion is a recessed structure corresponding in shape to the protruding structure, or the first positioning portion may be a recessed structure while the second positioning portion is a protruding structure corresponding in shape to the recessed structure. The foregoing designs of the positioning portions are advantageous in that the first positioning portion and the second positioning portion can be fastened to each other to prevent two connected supporting members from getting loose with respect to each other. In one preferred embodiment, the first positioning portion is a projection, and the second positioning portion is a recess. In embodiment 3 as well as embodiment 1, the front side of the first connecting portion 12 of the supporting member 100 is provided with a terminal positioning bump (i.e., the first positioning portion 121), and the bump can enter, in a sliding manner, a positioning hole (i.e., the second positioning portion 131) of the next implanted supporting member 100 to prevent the two supporting members 100 from sliding with respect to and separating from each other in either the forward or the rearward direction. In embodiment 4 as well as embodiment 2, the front side of the first connecting portion 12 of the supporting member 100 is provided with a terminal positioning block (i.e., the first positioning portion 121), and the block can enter, in a sliding manner, a positioning groove (i.e., the second positioning portion 131) of the next implanted supporting member 100 to prevent the two supporting members 100 from sliding with respect to and separating from each other in either the forward or the rearward direction. In one preferred embodiment, the main body 11 has a U-shaped groove structure 151 as shown in
[0054] The guiding structure 14 is formed at one side of the main body 11 and is configured to mate with an external template plug. The guiding structure 14 may be, for example but not limited to, the guiding holes 141 shown in
[0055] In one preferred embodiment, the material of the supporting member of the present invention includes a biocompatible material such as a biocompatible metal, a biocompatible plastic, or a mixture thereof. Suitable metals include but are not limited to magnesium alloys, tantalum alloys (e.g., TaC and TaN), titanium alloys (e.g., GUMMETAL®), nickel-titanium alloys, nickel-titanium-copper alloys, cobalt-chromium alloys (e.g., Elgiloy®, a non-magnetic cobalt-based hardenable cobalt-chromium-nickel superalloy), cobalt-chromium-nickel alloys (e.g., Phynox®), chromium-tungsten-nickel alloys (e.g., L605), cobalt-chromium-vanadium alloys, cobalt-nickel-chromium-molybdenum alloys (e.g., MP35N and MP20N), stainless steel (e.g., 316, 316L, and 304), and metallic glass. Suitable plastics include polymers, copolymers, composite materials, and mixtures of the above, such as but not limited to styrene-based elastomers, olefinic elastomers, polyolefinic elastomers, polyurethane-based thermoplastic elastomers, polyamides, polybutadienes, polyisobutylene, poly(styrene-butadiene-styrene), poly(2-chloro-1,3-butadiene), silicones, thermoplastic polyurethanes (TPU), polyurethanes (PU), polysiloxanes (e.g., polydimethylsiloxane (PDMS) and hard polydimethylsiloxane (h-PDMS)), poly(methyl methacrylate) (PMMA), polyetheretherketone (PEEK), ultra-high-molecular-weight polyethylenes (UHMWPE), and silicon rubber. In a more preferred embodiment, the material of the supporting member of the invention includes a titanium alloy. The foregoing embodiments are advantageous in that a plurality of supporting members may, depending on their material properties, be sequentially implanted into a bone or between two connected bones, fastened together, and vertically or horizontally stacked until the resulting supporting member assembly has the desired height/width and supporting strength.
[0056] The dimensions of the supporting member of the present invention are preferably determined according to the size of the space of the target implantation site and the size of the incision to be made for the implantation operation. For example, if the target implantation site is in a vertebra, the supporting member may have a relatively slender design to minimize the hole drilled into the vertebra and thereby protect the surrounding nerves and blood vessels from injury. That is to say, the supporting member of the invention can be adjusted and modified as needed. The invention imposes no limitation on the dimensions of the supporting member.
[Embodiment 5]—Supporting Member Assembly
[0057] Please refer to
[0058] The supporting member assembly 200 according to embodiment 5 is configured to be implanted into or between a subject's bones and includes the plural supporting members stated above, with the first connecting portion of each supporting member (except for the uppermost supporting member 25) forming a dovetail joint with the second connecting portion of the adjacent supporting member. As shown in
[0059] In one preferred embodiment, the supporting member assembly includes two to seven supporting members. In a more preferred embodiment, the supporting member assembly includes three to five supporting members. In the embodiment shown in
[0060] A plurality of supporting members of the present invention can be fastened together in a modular manner while being implanted into a bone or between two connected bones so as to form a vertical or horizontal stack of the desired height or width and with the desired supporting strength. The resulting supporting member assembly can push outward the end plate(s) to be treated, thereby expanding a fractured bone or providing interosseous fixation. The invention allows a plurality of supporting members to be connected in the tiny limited space in a bone or between two connected bones in order to stabilize the bone or firmly secure the connected bones. The number of the supporting members required to be implanted depends on the height of the bone to be restored or the distance between the two connected bones to be secured. Theoretically, the supporting member assembly can be made larger by adding as many supporting members as needed, until the bone to be restored or the space between the two connected bones to be secured is completely filled by the assembly. Thus, the invention overcomes the aforementioned drawback of the conventional one-size implants, i.e., failure to “be a single micro-unit before implantation into or between a subject's bones and connect with other similar micro-units sequentially implanted into or between the bones to form a larger yet complete block”. The invention also solves such problems of the conventional one-size implants as the likelihood of their rupturing the affected bone structure (e.g., a pedicle) or injuring the surrounding nerves (e.g., the spinal cord or spinal nerves), blood vessels (e.g., the abdominal aorta or the vertebral arteries), or other important tissues (e.g., the ureters) during implantation, and of their providing inadequate support due to an expediently smaller-than-required size.
[0061] To put together a plurality of supporting members of the present invention, two template plugs according to the invention can be sequentially mated to the guiding structures of the supporting members in order to guide each supporting member into a subject's bone or between two connected bones, connect each two successively implanted supporting members in a sliding manner, and fasten each two successively implanted supporting members together vertically. During the process, each template plug is removed from the supporting member it is mated to, after the other template plug has put the next supporting member in place. The implantation and connection process are detailed below with reference to
[0062] The supporting members 311 of the present invention are configured to work with a working assembly in order to be implanted. The supporting members 311 and the working assembly are herein referred to collectively as an implantation system 300.
[0063] The working assembly matches the supporting members 311 and is configured to implant the supporting members 311 into or between a subject's bones. The working assembly includes one or a combination of devices selected from the group consisting of an introducer (not shown), a reamer (not shown), a working cannula 33, a tamper (not shown), and a template plug 32.
[0064] The introducer includes an introducing portion, an extension portion, and a grip portion. The extension portion has one end connected to the introducing portion and the opposite end connected to the grip portion. The end of the introducing portion that is not connected to the extension portion is pointed and sharp. In one preferred embodiment, the introducing portion and the extension portion of the introducer may be solid or hollow. The introducer is configured to make a hole into a vertebra and gradually enlarge the hole so that the working cannula can be put into the hole. In fact, the introducer refers to any one of a series of solid or hollow introducers that have a needle-shaped introducing portion and vary in size so as to drill and enlarge a hole in a vertebra in a successive and gradual manner, lest a large hole drilled into the vertebra in one go injure the surrounding nerves or blood vessels.
[0065] The reamer includes a reaming portion, an extension portion, and a grip portion. The extension portion has one end connected to the reaming portion and the opposite end connected to the grip portion. The reaming portion is a sharp spiral structure with which the reamer can move or pull out bone debris. The sharp spiral structure of the reamer can be driven to a specific position in a bone and ream out bone debris for physiological examination.
[0066] The working cannula 33 includes a hollow tube and a grip portion. The hollow tube allows insertion by the introducing portion and the extension portion of the introducer, the slender shaft of the tamper, and the two connecting pins and the extension portion of the template plug 32. The hollow tubular structure of the working cannula 33 not only can accommodate the largest of the introducers used to gradually enlarge the hole drilled into a vertebra, but also serves as a passage for the reamer, the tamper, the template plug 32, and the supporting members 311 to be implanted, thereby limiting the working position of the implantation system 300.
[0067] Some examples of the tamper and of the template plug 32 will be detailed below with reference to embodiments 6 to 8.
[Embodiments 6 and 7]—Template Plug
[0068] Please refer to
[0069] The template plugs 400 according to embodiments 6 and 7 are both configured to guide the supporting member of the present invention into or between a subject's bones. Each template plug 400 includes a connecting pin 41, an extension portion 42, and a grip portion 43, wherein the extension portion 42 has one end connected to the connecting pin 41 and the opposite end connected to the grip portion 43.
[0070] The connecting pin 41 serves to mate with the guiding structure of a supporting member of the present invention and is therefore configured to match the guiding structure in, for example, position, structure, and/or number. As stated above, the guiding structure of a supporting member of the invention may include guiding holes and a buffer groove, both formed in one side of the main body of the supporting member, wherein the number of the guiding holes may be two, three, four, five, etc. It is therefore preferable that there are as many connecting pins as the guiding holes, i.e., two, three, four, or five connecting pins corresponding to two, three, four, or five guiding holes respectively. Take embodiments 1 to 4 for example. The supporting member in each of embodiments 1 to 4 has two guiding holes, and in order to mate with the two guiding holes, the template plug 400 in each of embodiments 6 and 7 has two connecting pins 41. In embodiment 7, referring to
[0071] To prevent a plurality of template plugs 400 that are used together from shifting in position during supporting member implantation, each template plug 400 may further include a coupling and positioning structure 44, i.e., a third connecting portion 441 and a fourth connecting portion 442. The third connecting portion 441 is located at an upper side of the extension portion 42 and the grip portion 43, while the fourth connecting portion 442 is located at a lower side of the extension portion 42 and the grip portion 43. For example, the third connecting portion 441 is a dovetail projection corresponding to the dovetail recess, or second connecting portion, of a supporting member of the present invention and can therefore be pushed into, advanced, and coupled with the dovetail recess of the supporting member in a sliding manner, and the fourth connecting portion 442 is a dovetail recess corresponding to the dovetail projection, or first connecting portion, of the supporting member and can therefore be pushed along, advanced, and coupled with the dovetail projection of the supporting member in a sliding manner. As another example, a template plug of the invention may have the same upper connecting portion (e.g., dovetail block) and lower connecting portion (e.g., dovetail groove) as a supporting member of the invention so as to connect with another template plug of the same configuration.
[0072] Referring to
[0073] In short, after the “second” template plug holding the “second” supporting member is moved along the “first” template plug and fastens the “second” supporting member to the “first” supporting member, the “first” template plug can be removed from the “second” template plug. By the same token, more than two supporting members can be sequentially introduced into and connected in a bone or between two connected bones.
[Embodiment 8]—Tamper
[0074] Please refer to
[0075] The tamper 500 is configured to match the supporting member of the present invention and includes a slender shaft 51 and a grip portion 52 connected to the slender shaft 51. The tamper 500 serves to restore a fractured bone and press down a supporting member that has just been implanted.
[0076] As shown in the enlarged views of
[0077] The structure of the slender shaft 51 is preferably similar to but flatter than that of the supporting member of the present invention, and the dimensions of the slender shaft 51 may vary to meet practical needs. In fact, a plurality of tampers 500 whose slender shafts 51 vary in size may be used sequentially, in an ascending order of the shaft sizes, to either gradually push upward the top side of a collapsed fractured vertebra in order to restore the height of the vertebra, or press down a supporting member that has just been implanted so as to make room for the next supporting member to be implanted.
[0078] Please refer to
[0079] As shown in
[0080] The present invention allows the supporting member 611 to be implanted into a subject's bone or between two connected bones, followed sequentially by more supporting members, which are connected to the supporting member 611 and to one another right in the bone or between the connected bones to form a supporting member assembly 61 (see
[0081] In summary of the above, the present invention provides a supporting member that is configured as a micro-unit and whose small size allows not only implantation into a bone or between two connected bones, but also connection with other such members in the bone or between the connected bones so as to form a supporting member assembly, making possible a minimally invasive, small-incision surgical operation. In addition, the invention provides an introducer that can make and gradually enlarge a hole into a bone to enable the placement of a working cannula into the hole; a reamer for moving or pulling out bone debris; a tamper for restoring a fractured bone and pushing a previously implanted supporting member; and a template plug that can be used to introduce a supporting member into a bone or between two connected bones, connect this supporting member to its immediate predecessor in a sliding manner, and fasten the two supporting members together vertically, before the template plug is removed from the supporting members. The invention further provides a supporting member assembly that is formed by sequentially implanting and connecting a plurality of supporting members into a bone or between two connected bones so as to push outward the end plate(s) to be treated and thereby expand the fractured collapsed bone(s). This supporting member assembly is an improvement over the one-size implants used in the conventional implantation techniques on the grounds that an existing one-size implant cannot “be a single micro-unit before implantation into or between a subject's bones and connect with other similar micro-units sequentially implanted into or between the bones to form a larger yet complete block”. Furthermore, unlike the traditional one-size implants, the supporting member assembly of the invention will not rupture the affected bone structure (e.g., a pedicle) or injure the surrounding nerves (e.g., the spinal cord or spinal nerves), blood vessels (e.g., the abdominal aorta or the vertebral arteries), or other important tissues (e.g., the ureters) during implantation, or provide inadequate support due to an expediently smaller-than-required size.
[0082] The above is the detailed description of the present invention. However, the above is merely the preferred embodiment of the present invention and cannot be the limitation to the implement scope of the present invention, which means the variation and modification according to the present invention may still fall into the scope of the invention.