CN109893188B - Degradable tendon anastomat - Google Patents
Degradable tendon anastomat Download PDFInfo
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- CN109893188B CN109893188B CN201910317101.4A CN201910317101A CN109893188B CN 109893188 B CN109893188 B CN 109893188B CN 201910317101 A CN201910317101 A CN 201910317101A CN 109893188 B CN109893188 B CN 109893188B
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- anastomat
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- 210000002435 tendon Anatomy 0.000 title claims abstract description 97
- 230000007246 mechanism Effects 0.000 claims abstract description 12
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 20
- 229910052751 metal Inorganic materials 0.000 claims description 20
- 229910052725 zinc Inorganic materials 0.000 claims description 20
- 239000011701 zinc Substances 0.000 claims description 20
- 239000002184 metal Substances 0.000 claims description 19
- 229910001297 Zn alloy Inorganic materials 0.000 claims description 8
- 229910000881 Cu alloy Inorganic materials 0.000 claims description 6
- TVZPLCNGKSPOJA-UHFFFAOYSA-N copper zinc Chemical compound [Cu].[Zn] TVZPLCNGKSPOJA-UHFFFAOYSA-N 0.000 claims description 4
- 229910000882 Ca alloy Inorganic materials 0.000 claims description 3
- VVZJQVZLLAFNFB-UHFFFAOYSA-N [Sr].[Zn].[Li] Chemical compound [Sr].[Zn].[Li] VVZJQVZLLAFNFB-UHFFFAOYSA-N 0.000 claims description 3
- ISZIYIIDGMIKEV-UHFFFAOYSA-N [Zn].[Li].[Ca] Chemical compound [Zn].[Li].[Ca] ISZIYIIDGMIKEV-UHFFFAOYSA-N 0.000 claims description 3
- WJZHMLNIAZSFDO-UHFFFAOYSA-N manganese zinc Chemical compound [Mn].[Zn] WJZHMLNIAZSFDO-UHFFFAOYSA-N 0.000 claims description 3
- 229910001316 Ag alloy Inorganic materials 0.000 claims description 2
- 229910000861 Mg alloy Inorganic materials 0.000 claims description 2
- 229910000914 Mn alloy Inorganic materials 0.000 claims description 2
- SGNOAYMDWRPWMS-UHFFFAOYSA-N [Cu].[Zn].[Li] Chemical compound [Cu].[Zn].[Li] SGNOAYMDWRPWMS-UHFFFAOYSA-N 0.000 claims description 2
- GCOWTRMQPXDRQQ-UHFFFAOYSA-N [Mg].[Cu].[Zn] Chemical compound [Mg].[Cu].[Zn] GCOWTRMQPXDRQQ-UHFFFAOYSA-N 0.000 claims description 2
- PGTXKIZLOWULDJ-UHFFFAOYSA-N [Mg].[Zn] Chemical compound [Mg].[Zn] PGTXKIZLOWULDJ-UHFFFAOYSA-N 0.000 claims description 2
- XVYHFPMIBWTTLH-UHFFFAOYSA-N [Zn].[Mg].[Ca] Chemical compound [Zn].[Mg].[Ca] XVYHFPMIBWTTLH-UHFFFAOYSA-N 0.000 claims description 2
- BSWGGJHLVUUXTL-UHFFFAOYSA-N silver zinc Chemical compound [Zn].[Ag] BSWGGJHLVUUXTL-UHFFFAOYSA-N 0.000 claims description 2
- 230000006378 damage Effects 0.000 abstract description 7
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- 239000011777 magnesium Substances 0.000 description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 5
- 229910002056 binary alloy Inorganic materials 0.000 description 5
- 230000035876 healing Effects 0.000 description 5
- 229910052749 magnesium Inorganic materials 0.000 description 5
- 239000011572 manganese Substances 0.000 description 5
- 229910002058 ternary alloy Inorganic materials 0.000 description 5
- 102000008186 Collagen Human genes 0.000 description 4
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- 239000010949 copper Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 210000000426 patellar ligament Anatomy 0.000 description 4
- WHXSMMKQMYFTQS-UHFFFAOYSA-N Lithium Chemical compound [Li] WHXSMMKQMYFTQS-UHFFFAOYSA-N 0.000 description 3
- 230000003872 anastomosis Effects 0.000 description 3
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- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 2
- 229910052692 Dysprosium Inorganic materials 0.000 description 2
- 229910052688 Gadolinium Inorganic materials 0.000 description 2
- 239000012981 Hank's balanced salt solution Substances 0.000 description 2
- PWHULOQIROXLJO-UHFFFAOYSA-N Manganese Chemical compound [Mn] PWHULOQIROXLJO-UHFFFAOYSA-N 0.000 description 2
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- KBQHZAAAGSGFKK-UHFFFAOYSA-N dysprosium atom Chemical compound [Dy] KBQHZAAAGSGFKK-UHFFFAOYSA-N 0.000 description 2
- UIWYJDYFSGRHKR-UHFFFAOYSA-N gadolinium atom Chemical compound [Gd] UIWYJDYFSGRHKR-UHFFFAOYSA-N 0.000 description 2
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- 229910052712 strontium Inorganic materials 0.000 description 2
- CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 description 2
- 230000004580 weight loss Effects 0.000 description 2
- 229910052727 yttrium Inorganic materials 0.000 description 2
- VWQVUPCCIRVNHF-UHFFFAOYSA-N yttrium atom Chemical compound [Y] VWQVUPCCIRVNHF-UHFFFAOYSA-N 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 241001391944 Commicarpus scandens Species 0.000 description 1
- JPVYNHNXODAKFH-UHFFFAOYSA-N Cu2+ Chemical compound [Cu+2] JPVYNHNXODAKFH-UHFFFAOYSA-N 0.000 description 1
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- 229910007921 Li-Ca Inorganic materials 0.000 description 1
- 229910008414 Li-Sr Inorganic materials 0.000 description 1
- 229910008298 Li—Ca Inorganic materials 0.000 description 1
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 1
- 229910001278 Sr alloy Inorganic materials 0.000 description 1
- 229910001069 Ti alloy Inorganic materials 0.000 description 1
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 description 1
- 229910007565 Zn—Cu Inorganic materials 0.000 description 1
- WCULPSIYAQDUJW-UHFFFAOYSA-N [Li].[Sr] Chemical compound [Li].[Sr] WCULPSIYAQDUJW-UHFFFAOYSA-N 0.000 description 1
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- WPBNNNQJVZRUHP-UHFFFAOYSA-L manganese(2+);methyl n-[[2-(methoxycarbonylcarbamothioylamino)phenyl]carbamothioyl]carbamate;n-[2-(sulfidocarbothioylamino)ethyl]carbamodithioate Chemical compound [Mn+2].[S-]C(=S)NCCNC([S-])=S.COC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OC WPBNNNQJVZRUHP-UHFFFAOYSA-L 0.000 description 1
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Substances [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 1
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Abstract
The invention discloses a degradable tendon anastomat. The device comprises positioning rods and locking pieces, wherein the number of the positioning rods is at least two, locking holes are formed in two ends of each positioning rod and can be used for the locking pieces to pass through, and locking mechanisms are arranged on the locking pieces and used for locking the relative positions between the positioning rods and the locking pieces; the locking mechanism is a plurality of protrusions that pass through the locking hole in one direction and are caught by the edge of the locking hole in the opposite direction. The tendon anastomat is made of degradable metal materials, and can be completely absorbed by human body finally. The tendon anastomat can keep the broken ends of the tendons in contact without suturing, reduces secondary damage to the broken ends, and can also effectively solve the problems of postoperative adhesion, tendon function decline and the like.
Description
Technical Field
The invention relates to a degradable tendon anastomat, in particular to a zinc-based degradable tendon anastomat.
Background
Tendon injury is the most common injury, the most preferred treatment method for patients with tendon injury in clinic at present is suture repair, and a plurality of tendon suturing methods are commonly used in clinic at present, wherein the tendon suturing methods comprise a Kessler method, a Kleinert method and an under-body fluid method, and the traditional 8-shaped suturing method are improved and improved based on the methods. However, the traditional sewing method is high in tension, so that the condition of suture fracture or broken end dislocation is easy to occur; and tendon adhesion often occurs after tendon suturing, which results in poor postoperative function recovery and affects tendon function.
In various tendon repair technologies in clinic, needle threads are inserted and sewed in different modes to directly draw up broken ends of tendons, the sewing direction is mainly the longitudinal direction (the long axis direction of the tendon), and different sewing methods are to add oblique, transverse and lasso needle methods on the basis of the longitudinal direction. All the repairing methods are sutured within 5-8 mm of the tendon end. This needle and line repair technique has two fatal weaknesses: 1. tendons are composed of tenocytes and collagen, the latter building up into bundles, groups, and further tendons. Collagen fibers in the tendon, bundles and groups of the collagen fibers are longitudinally arranged, and a certain gap exists between the collagen fibers and the bundles, so that the force of longitudinal traction is easy to break; 2. in the tendon healing process, 5-8 mm of broken ends of the tendons can swell, engorge and soften, and the suture is very easy to cut off the softened tissue, so that the anastomotic stoma is cracked and broken. Thus, 3 weeks of post-tenodesis braking are clinically required.
To improve this situation, chinese patent document with publication No. CN101991445a provides a central tendon anastomat, which is composed of a body, two sutures and two suture needles, wherein the body is a long strip structure made of degradable biological material, the middle section is in the shape of an elliptic cylinder, the two ends are in the shape of an elliptic cone, one ends of the two sutures are respectively connected with the two ends of the body, and the other ends of the two sutures are respectively connected with the tails of the two suture needles. The central tendon anastomat is used for stitching two broken ends of the tendon on one tendon anastomat, and simultaneously the tension direction of the suture can be made to be a transverse drawing, so that the stress point of the tendon after stitching is located at the broken end of the tendon by more than 8 mm. However, the anastomat still needs to be sutured when in use, secondary damage is caused to the broken end of the tendon, and the force exerted by the body is still longitudinal force, so that the anastomat is still easy to open.
In order to strengthen the strength of absorbable suture, chinese patent document publication No. CN206285291U provides a magnesium-based metal tendon anastomosis device, and designs two structures of U-shape and V-shape, the device has a simple structure and is not complicated to operate, but the anastomosis principle still makes tendons longitudinally stressed, and the problem of easy opening cannot be avoided. In addition, once the positions of the two anastomat needles are selected, fine adjustment cannot be performed, and the best anastomosis effect is difficult to ensure. In addition, the ultimate tensile strength of the degradable magnesium-based metal is more than 200-300MPa, and correspondingly, the ultimate tensile strength of the titanium alloy implant which is commonly used in clinic at present is between 500MPa and 1000MPa, and the elongation is about 20 percent, so that the magnesium-based metal still cannot meet the requirements of orthopaedics endophytes.
Zinc is a trace element necessary for human body, 90% of zinc is stored in muscle and bone, is one of the most important elements in protein synthesis and energy metabolism, and participates in a great deal of physiological reaction processes such as human cell development and growth, gene expression, immune system and nervous system. In the research process of degradable zinc-based metal, the zinc-based metal has good biocompatibility and safety, excellent mechanical property, ultimate tensile strength up to 680MPa and elongation of 10% -80%, and can meet the basic requirements of preparing orthopaedics endophyte in theory. In addition, zinc also has a promoting effect on tendon growth. Thus, these suggest that we use zinc-based metals in the design of tendon anastomat.
Disclosure of Invention
In view of the above problems in the prior art, an object of the present invention is to provide a degradable tendon anastomat which tendon suture is not required, damage to tendon ends can be reduced, adhesion after suture can be effectively reduced, and mechanical properties are excellent.
In order to achieve the above purpose, the invention provides a degradable tendon anastomat, which comprises at least two positioning rods and locking pieces, wherein the two ends of each positioning rod are provided with locking holes for the locking pieces to pass through, and the locking pieces are provided with locking mechanisms for locking the relative positions between the positioning rods and the locking pieces. The tendon anastomat is made of degradable metal materials, and can be completely absorbed by human body finally.
The positioning rods can transversely penetrate through tendons, for example, two positioning rods can respectively penetrate through tendons at two sides close to tendon fracture positions, and the relative positions of the tendons at two sides are locked through locking pieces by locking holes at two ends of the positioning rods, so that the tendons at two sides fracture mutually contact, and the tendon fracture positions can be anastomosed without suturing.
Thus, for better penetration of the tendon, the positioning rod is preferably a cylindrical rod with a pointed tip, which shape is not unique, and an elliptic cylinder, a square cylinder with rounded corners are possible in addition to the cylindrical shape.
The number of the positioning rods can be 2-6, preferably 4, according to the requirement, because the fixing force of the 4 positioning rods is relatively large, the tensioning degree is convenient to adjust, and the number of the 4 positioning rods is not larger than that of the tendons.
Further, the locking mechanism is a plurality of protrusions that pass through the locking hole in one direction and are caught by the edge of the locking hole in the opposite direction. The locking principle described above is similar to the strapping principle commonly used in life.
Preferably, the locking element is a degradable thread with projections, particularly preferably a degradable wire.
In a preferred embodiment of the invention, the locking element has two axially symmetrical projections on the main shaft, all projections having outwardly extending oblique contours, and all the oblique contours extending at least sectionally or all in the same direction along the main shaft of the locking element, and the distance from the furthest end of the oblique contours to the main shaft of the locking element being slightly greater than the distance from the edge of the locking hole to the main shaft of the locking element. As used herein, "slightly larger" is a condition that the locking element is allowed to pass through the locking aperture in one direction and be caught by the edge of the locking aperture in the other direction.
The shape of the projections may be triangular, trapezoidal, etc., but it is most preferable to make the projections in the shape of straight barbs directly in terms of ease of manufacture.
Further, the number of the locking members may be one or two or more. In a preferred embodiment of the present invention, the locking member is a degradable metal wire with paired linear barbs, and two sections of linear barbs (i.e. with opposite inclined directions) open towards each other are respectively disposed inwards from two ends of the main shaft of the locking member, and can pass through the locking holes on two sides respectively after being bent in a U shape, and finally, the two ends of the metal wire are pulled together to form a knot or not. In another preferred embodiment of the present invention, the locking member is a pair of linear barbed degradable wires in two separate strips, and the ends of the wires are designed to be blocked and cannot pass through the locking holes, and the front ends of the wires can be respectively tensioned, knotted or not knotted after passing through the locking holes on two sides.
The invention can change the size of the tendon anastomat according to the tendon injury of different parts, including the length and the diameter of the positioning rods and the number of the positioning rods at two sides of the tendon fracture.
Further, the length of the positioning rod is preferably 2-4cm, the diameter is preferably 2-3mm, the diameter of the locking hole is preferably 1.5-2mm, and the diameter of the main shaft of the locking member is preferably 1-1.5mm.
The positioning rod in the invention needs to have the functions of firm positioning, no movement and no deformation, so the positioning rod is preferably made of a degradable metal material with high strength.
Preferably, the degradable tendon anastomat is made of zinc-based material; the zinc-based material is pure zinc or zinc alloy with the mass fraction of zinc reaching more than 90 percent.
Further, single or multiple metal elements may be added to the zinc alloy, and the added elements include, but are not limited to: magnesium Mg, copper Cu, silver Ag, lithium Li, manganese Mn, strontium Sr, calcium Ca, yttrium Y, gadolinium G and dysprosium Dy; wherein the mass ratio of each element in the alloy is not more than 5%, and the total mass fraction of each element is not more than 10%; further, the mass fraction of each of the silver, lithium, manganese, strontium, yttrium, gadolinium and dysprosium elements is not more than 1%, more preferably not more than 0.6%.
In a preferred embodiment of the present invention, the zinc alloy is a binary zinc-based alloy such as zinc-magnesium alloy, zinc-copper alloy, zinc-manganese alloy, zinc-silver alloy, etc.; in another preferred embodiment of the present invention, the zinc alloy is a ternary zinc-based alloy, such as zinc-magnesium-calcium alloy, zinc-lithium-copper alloy, zinc-lithium-calcium alloy, zinc-lithium-strontium alloy, zinc-magnesium-copper alloy, and the like.
In a preferred embodiment of the invention, the zinc alloy is a binary alloy, for example, a zinc-copper binary alloy, wherein the copper-containing mass fraction is 1% -3%, further preferably 1.5% -2.5%; alternatively, a zinc-manganese binary alloy in which the mass fraction of manganese is 0.1 to 0.6%, more preferably 0.3 to 0.5%.
In another preferred embodiment of the invention, the zinc alloy is a lithium-containing ternary alloy, such as a zinc-lithium-calcium ternary alloy or a zinc-lithium-strontium ternary alloy, wherein the sum of the mass fractions of lithium-calcium or lithium-strontium is not more than 1.5%.
The invention has the following beneficial technical effects:
(1) The tendon anastomat adopts the positioning rod and the locking piece to fix the positions of two ends of the fractured tendon, so that the fractured tendon ends can be kept in contact without suturing, secondary damage to the fractured tendon ends is reduced, and the problems of adhesion after operation, tendon function decline and the like can be effectively solved;
(2) The invention uses the ribbon principle to position and lock the two ends of the broken tendon, and the designed anastomat has simple structure and easy manufacture;
(3) The positioning rod is used for transversely fixing the tendons, namely, the transverse supporting force is applied to the tendons, so that the tendons can be prevented from being broken by longitudinal pulling force;
(4) Compared with degradable magnesium-based metal, the degradable zinc-based metal can provide higher tensile strength, meet the basic requirements of orthopaedics internal plants, and can maintain mechanical stability in early stage;
(5) The zinc ions, magnesium ions, copper ions and the like which are gradually degraded and released in the degradable zinc-based alloy can provide antibacterial and bone and other biological functions, and further enhance the superiority of the zinc-based metal orthopaedics application.
The conception, specific structure, and technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, features, and effects of the present invention.
Drawings
FIG. 1 is a schematic view of a preferred embodiment of a tendon anastomat according to the present invention;
FIG. 2 is a schematic view of a tendon anastomat according to another preferred embodiment of the present invention;
FIG. 3 is a schematic view of the overall structure of the locking element of the embodiment of FIG. 1;
FIG. 4 is a schematic view showing different structures of the protrusions of the locking member in the tendon anastomat of the present invention, wherein a is a straight line, b is a triangle, and c is a trapezoid;
in the attached drawings, 1, a positioning rod; 2. a locking hole; 3. a locking member; 4. a locking mechanism; 5. tendons; 6. the key is blocked.
Detailed Description
Example 1
A preferred structure of the degradable tendon anastomat of the invention is shown in figure 1, the tendon anastomat comprises four positioning rods 1 and a locking piece 3, the two ends of the positioning rods 1 are provided with locking holes 2, the locking piece 3 is a long degradable metal wire and is provided with locking mechanisms 4 which are arranged in pairs, the locking mechanisms 4 are linear protrusions (barbs) which extend outwards in an inclined mode, the distance from the farthest end of the linear protrusion to the metal wire is slightly larger than the distance from the edge of the locking hole 2 to the metal wire, therefore, the locking hole 2 can be penetrated by the locking piece 3, and only along the inclined direction of the linear protrusion can be penetrated by the locking hole 2, and the opposite direction can not be penetrated but can be locked. This principle is similar to the ribbon principle commonly used in life. As can be seen from fig. 1 and 3, the linear protrusion in this embodiment is divided into two sections, and the inclined openings are inward from both ends of the wire to positions along the wire to the middle portion thereof, respectively.
As can be seen from fig. 1, the positioning rod 1 is in operation transversely penetrating through the tendon, so that the main body of the positioning rod 1 is cylindrical, and one end of the positioning rod is provided with a pointed end, so that the positioning rod can conveniently penetrate into the tendon. Besides cylindrical, elliptical cylindrical, square cylindrical designs with rounded corners are also possible. The number of the positioning rods in the embodiment is 4, but in practical cases, the number of 2-6 positioning rods is common, and two sides of the fracture can be selected to be positioned by adopting different numbers of positioning rods according to the situation of the fracture position of the tendon.
When the tendon anastomat in fig. 1 is installed, the positioner 1 can be inserted into and pass through the positions, which are needed to be positioned, of two sides of a broken tendon, the locking holes 2 at the two ends are exposed, then one end of the locking mechanism 4 passes through the tendon beside the positioner 1, the direction barbs are not required to be pulled into the tendon so as to avoid great damage to the tendon, the two ends of the locking mechanism 4 respectively pass through the locking holes 2 of all the positioners at the side, finally, the two ends of the locking mechanism 4 are tensioned according to the needs along the arrow direction in the figure, the two ends of the broken tendon are contacted with each other, and the two ends of the broken tendon can be knotted or not knotted after the positions are determined, so that the tendon anastomat is only locked. The embodiment has the advantages that the tendon can be tensioned by pulling one metal wire, and the two sides are easy to be symmetrical.
In view of the fact that penetration of the locking member 4 into the tendon causes a certain injury to the tendon, another preferred embodiment of the present invention is provided in fig. 2, in which two separate locking members 3 are used, which can pass through the locking holes 2 on both sides of the tendon, respectively, and the end of the locking member 3 has a locking key 6, which can be locked on the locking holes 2, for fixing the end of the locking member 3, but this embodiment has a disadvantage in that the degree of tightening of both sides is difficult to control exactly the same, and both sides are easily asymmetric.
In addition to the linear projections described above, triangular and trapezoidal projection shapes are shown in fig. 4, but any other shape is possible that satisfies the principles of the present invention.
The invention can change the size of the tendon anastomat according to the tendon injury of different parts, including the length, the diameter and the like of the positioning rod. The length of the positioning rod 1 is preferably 2-4cm, the diameter is preferably 2-3mm, the diameter of the locking hole 2 is preferably 1.5-2mm, and the diameter of the main shaft of the locking element 3 is preferably 1-1.5mm.
Example 2 degradable anastomat for Achilles tendon fracture healing
A Zn-Mn binary alloy is selected, a locating rod with the diameter of 2mm and the length of 3cm is prepared by Zn-0.4Mn (Mn wt0.4%, ultimate tensile strength UTS=260 MPa, yield strength YS=160 MPa, and elongation percentage > 40%), round holes with the diameter of 1.5mm are respectively prepared at the positions 3mm away from the two ends of the locating rod to serve as locking holes, and a full-length barb metal wire with the diameter of 1.25mm is prepared by Zn-0.4Mn alloy.
When the device is used, the device is cut and exposed, the broken ends of the Achilles tendon are positioned, then 3 positioning rods are sequentially arranged along the broken ends to two sides respectively, the distance is kept to be about 5mm, then the barbed wires sequentially penetrate through round holes reserved at the two ends of the positioning rod 1 along the direction indicated by an arrow in fig. 1, and after the barbed wires penetrate through all the positioning rods, the locking wires are gradually tensioned until the broken ends of the tendons at the two sides are contacted with each other.
Example 3 degradable anastomat for patellar tendon fracture healing
A Zn-Cu binary alloy is selected, a locating rod with the diameter of 3mm and the length of 3cm is prepared by Zn-2Cu (Cu wt2%, UTS=270 MPa, YS=230 MPa and the elongation rate is more than 40%), round holes with the diameter of 2mm are respectively prepared at the positions 3mm away from the two ends of the locating rod to be used as locking holes, and a full-length barb metal wire with the diameter of 1.5mm is prepared by Zn-2Cu alloy.
When the knee joint center incision is used, the patellar tendon broken ends are exposed and positioned, then 4 positioning rods are sequentially arranged along the broken ends to two sides respectively, the distance is kept about 5mm, then barb wires sequentially penetrate through round holes reserved at two ends of the positioning rod 1 along the direction indicated by an arrow in fig. 1, and after penetrating through all the positioning rods, the locking wires are gradually tensioned until the tendon broken ends at two sides are in contact with each other.
Example 4 degradable anastomat for Achilles tendon fracture healing
A Zn-Li-Sr ternary alloy is selected, a locating rod with the diameter of 2mm and the length of 3cm is prepared by Zn-0.4Li-0.1Sr (Li wt0.4%, sr wt0.1%, UTS=505 MPa, YS=372 MPa and elongation percentage > 50%), a round hole with the diameter of 1.5mm is prepared at the position 3mm away from the two ends of the locating rod and is used as a locking hole, and a full-length barb metal wire with the diameter of 1.25mm is prepared by Zn-0.4Li-0.1Sr alloy.
When the device is used, the device is cut and exposed, the broken ends of the Achilles tendon are positioned, then 3 positioning rods are sequentially arranged along the broken ends to two sides respectively, the distance is kept to be about 5mm, then the barbed wires sequentially penetrate through round holes reserved at the two ends of the positioning rods along the direction indicated by an arrow in fig. 1, and after the barbed wires penetrate through all the positioning rods, the locking wires are gradually tensioned until the broken ends of the tendons at the two sides are contacted with each other.
Example 5 degradable anastomat for patellar tendon fracture healing
A Zn-Li-Ca ternary alloy is selected, a locating rod with the diameter of 3mm and the length of 3cm is prepared by Zn-0.4Li-0.1Ca (Li wt0.4%, ca wt0.1%, UTS=500 MPa, YS=430 MPa and elongation percentage > 15%), a round hole with the diameter of 2mm is prepared at the position 3mm away from the two ends of the locating rod and is used as a locking hole, and a full-length barb wire with the diameter of 1.5mm is prepared by Zn-0.4Li-0.1Ca alloy.
When the knee joint center incision is used, the patellar tendon broken ends are exposed and positioned, then 4 positioning rods are sequentially arranged along the broken ends to two sides respectively, the distance is kept about 5mm, then the barb wires sequentially penetrate through round holes reserved at two ends of the positioning rods along the direction indicated by an arrow in fig. 1, and after penetrating through all the positioning rods, the locking wires are gradually tensioned until the tendon broken ends at two sides are in contact with each other.
Example 6
The electrochemical performance and corrosion performance of the zinc-based alloy selected by the invention are tested according to the following standard flow:
(1) Electrochemical testing
The tests were carried out in Hank's solution at room temperature using an electrochemical workstation (Autolab, metrohm, switzerland). A three electrode system employing a platinum electrode-Saturated Calomel Electrode (SCE) was used for electrochemical testing. Open circuit potential (Open-circuit potential, OCP) monitoring was performed for 5400 seconds for each sample. Electrochemical impedance spectroscopy (Electrochemical impedance spectroscopy, EIS) was tested at a frequency of 10mV, measured at a frequency of 10 5 To 10 -2 Under Hz conditions. Then potentiodynamic polarization test (Potentiodynamic polarization test) was carried out at a rate of 1mV/s with a test area of 0.2826cm 2 (phi 6 mm). At least five measurements were made per sample set. Analysis of corrosion parameters of the negative and positive portions of the polarization curve by the Linear fit and Tafel extrapolation method, including Open Circuit Potential (OCP), corrosion potential (E corr ) And corrosion current density (i) corr )。
1.2 soaking experiments
The soaking experiments were performed in Hank's solution at 37 ℃. The pH of the solution was recorded by a pH meter (Mettler FiveEasy pH FE K) at various time points during the soaking. After removal of corrosion products, the weight loss of the samples was measured on an electronic balance (XS 105, METTLER toledo) with a measurement sensitivity of 0.1mg, five measurements were made on average per group. The in vitro corrosion rate was calculated according to the following formula: c=Δm/ρat, where C is the corrosion rate in mm/year, Δm is the weight loss, ρ is the density of the material, a is the initial immersion surface area, and t is the implantation time.
The results of some of the tests are shown in Table 1.
TABLE 1 electrochemical parameters of pure Zinc and Zinc alloys in SBF solution (37.+ -. 0.2 ℃ C.)
Note that: the numbers in brackets are standard deviations
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.
Claims (10)
1. The degradable tendon anastomat is characterized by comprising positioning rods and locking pieces, wherein the number of the positioning rods is at least two, locking holes are formed in two ends of each positioning rod and can be used for the locking pieces to pass through, and locking mechanisms are arranged on the locking pieces and used for locking the relative positions between the positioning rods and the locking pieces.
2. The degradable tendon anastomat of claim 1, wherein the positioning rod is a cylindrical rod with a pointed tip.
3. The degradable tendon anastomat of claim 1, wherein the locking mechanism is a protrusion, the number of protrusions being plural, being able to pass through the locking hole in one direction and be caught by an edge of the locking hole in the opposite direction.
4. A degradable tendon anastomat as claimed in claim 1 or 3, wherein the locking element is a degradable thread with projections.
5. A degradable tendon anastomat as in claim 3, wherein the locking element has two axially symmetrical protrusions on the main shaft, all of the protrusions having outwardly extending inclined contours, all of the inclined contours extending at least sectionally or all in the same direction along the main shaft of the locking element, and the distance from the furthest end of the inclined contours to the main shaft being slightly greater than the distance from the edge of the locking hole to the main shaft.
6. The degradable tendon anastomat of claim 3, wherein the protrusions are triangular, trapezoidal or linear in shape.
7. A degradable tendon anastomat as claimed in claim 1 or 3, wherein the locking member is a degradable metal wire with paired linear barbs, and two sections of linear barbs which are open towards each other are respectively arranged inwards from two ends of the locking member spindle.
8. A degradable tendon anastomat as claimed in claim 1 or 3, which is made of pure zinc or zinc alloy with a mass fraction of zinc of more than 90%.
9. The degradable tendon anastomat of claim 8, wherein the degradable tendon anastomat is made of zinc-magnesium alloy, zinc-copper alloy, zinc-silver alloy or zinc-manganese alloy.
10. The degradable tendon anastomat of claim 8, wherein the degradable tendon anastomat is made of zinc-magnesium-calcium alloy, zinc-lithium-copper alloy, zinc-lithium-calcium, zinc-lithium-strontium or zinc-magnesium-copper alloy.
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| US5916224A (en) * | 1997-07-09 | 1999-06-29 | The United States Of America As Represented By The Secretary Of The Army | Tendon repair clip implant |
| CN206285291U (en) * | 2016-07-19 | 2017-06-30 | 上海交通大学医学院附属第九人民医院 | A kind of magnesium-base metal tendon anastomosis device |
| CN210095810U (en) * | 2019-04-19 | 2020-02-21 | 上海交通大学医学院附属第九人民医院 | Degradable tendon anastomat |
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| US6984241B2 (en) * | 1996-09-13 | 2006-01-10 | Tendon Technology, Ltd. | Apparatus and methods for tendon or ligament repair |
| US9119906B2 (en) * | 2008-09-24 | 2015-09-01 | Integran Technologies, Inc. | In-vivo biodegradable medical implant |
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| US5916224A (en) * | 1997-07-09 | 1999-06-29 | The United States Of America As Represented By The Secretary Of The Army | Tendon repair clip implant |
| CN206285291U (en) * | 2016-07-19 | 2017-06-30 | 上海交通大学医学院附属第九人民医院 | A kind of magnesium-base metal tendon anastomosis device |
| CN210095810U (en) * | 2019-04-19 | 2020-02-21 | 上海交通大学医学院附属第九人民医院 | Degradable tendon anastomat |
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