CN109893188A - A kind of degradable type tendon stapler - Google Patents

A kind of degradable type tendon stapler Download PDF

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Publication number
CN109893188A
CN109893188A CN201910317101.4A CN201910317101A CN109893188A CN 109893188 A CN109893188 A CN 109893188A CN 201910317101 A CN201910317101 A CN 201910317101A CN 109893188 A CN109893188 A CN 109893188A
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degradable
locking piece
tendon
zinc
locating rod
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CN201910317101.4A
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CN109893188B (en
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贾博
曲新华
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Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
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Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
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Abstract

The invention discloses a kind of degradable type tendon staplers.Including locating rod and locking piece, wherein the quantity at least two of locating rod, the both ends of the locating rod all have lock hole, pass through for the locking piece, have locking mechanism on the locking piece, for locking the relative position between locating rod and locking piece;The locking mechanism is protrusion, the quantity of the protrusion be it is multiple, the lock hole can be passed through in one direction, and blocked in the opposite direction by the edge of the lock hole.The type tendon stapler is made of degradable metal material, can finally be fully absorbed by human body.The problems such as type tendon stapler of the invention can be such that the tendon broken ends of fractured bone is kept in contact without carrying out suture, reduce the secondary damage to the broken ends of fractured bone, can also be effectively relieved post-operation adhesion, tendon function reduction.

Description

A kind of degradable type tendon stapler
Technical field
The present invention relates to a kind of degradable type tendon stapler more particularly to a kind of degradable type tendon staplers of zinc-base.
Background technique
Tendon injury is most commonly seen damage, at this stage clinically for the treatment method of patient's first choice of tendon injury That suture is repaired, clinically common tendon suture method has much at present, wherein it is more commonly used including Kessler method, Kleinert method, saliva laxative remedy and traditional " 8 " word sewing, other methods are mostly the improvement and improvement on the basis of the method. However since traditional suturing method receiving tension is larger, easily there is the case where suture breaks or broken ends of fractured bone dislocation;And tendon suture It often will appear adhesion of tendon afterwards, and then postoperative function caused to restore poor, influence tendon function.
Clinically it is disconnected to be all that needlework directly draw tendon over to one's side by the interspersed suture of different modes for various tendon repair technologies End, suture direction are based on longitudinal direction (tendon long axis direction), and different sewing methods is exactly to add on the basis of longitudinal direction Oblique, transverse direction, the skill of handling needles of lasso.And all restorative procedures are all sewn within 5~8mm of the tendon broken ends of fractured bone.This needle There are two deadly defects for line recovery technique: 1, tendon is to constitute collagenous fibres by Tenocyte cell and collagen, and the latter is accumulated into Beam, group, further constitute tendon.Collagenous fibres and its beam, group in tendon are all in longitudinal arrangement, there is a fixed gap therebetween, The strength thus longitudinally pulled, which is easy to draw, slits;2,5~8mm of tendon broken ends of fractured bone meeting swelling, hyperemia, softening in healing process of tendon, Suture easily cuts the tissue of this softening open, and causes previous anastomotic to be split, draws and slit.Therefore, tendon shift is clinically required It brakes 3 weeks afterwards.
In order to improve this case, the Chinese patent document of Publication No. CN101991445A provides a kind of center type flesh Tendon matching device, it is made of body portion, two sutures and two sewing needles, and body portion is long made of degradable biological material Strip structure, middle section are the cylindroid bodily form, and both ends are the elliptic cone bodily form, one end of two sutures both ends with body portion respectively It is connected, the other end of two sutures is connected with the tail portion of two sewing needles respectively.The central type tendon stapler is by tendon two The broken ends of fractured bone is sewn on a type tendon stapler, while suture tension direction row can be made to draw over to one's side, allow suture after tendon by Force is located at tendon broken ends of fractured bone 8mm with remote.But the stapler still needs to suture when in use, still can cause to the tendon broken ends of fractured bone Secondary damage, and the power granted of body portion is in fact or longitudinal force, is still easy to draw to slit.
In order to reinforce the intensity of absorbable suture, the Chinese patent document of Publication No. CN206285291U provides one Kind magnesium-base metal tendon anastomosis device, and two kinds of structures of U-shaped and V-arrangement are devised, the apparatus structure is simple, operates also not multiple Miscellaneous, but it coincide, principle, which is still, makes tendon longitudinal stress, still not can avoid and is easy to draw open-minded problem.And it is above two Stapler can not be finely adjusted once selected the pricked position of syringe needle, it is more difficult to guarantee best match result.In addition, degradable magnesium The ultimate tensile strength multidigit of Base Metal is in this section 200-300MPa, and corresponding, clinically used titanium alloy is planted now Enter object, ultimate tensile strength is between 500MPa-1000MPa, and elongation percentage is 20% or so, it is seen that magnesium-base metal is still unable to satisfy The requirement of orthopedic implant.
Zn-ef ficiency is the essential trace elements of the human body, and it is albumen that the Zn-ef ficiency of human body 90%, which is stored in muscle and bone, One of most important element, the growth of participant's somatocyte development, gene expression, immune system in matter synthesis and energy metabolism With a large amount of physiological reaction processes such as nervous system.In the research process to degradable zinc-base metal, it has been found that zinc-base metal There are good biocompatibility and safety, and excellent in mechanical performance, ultimate tensile strength reaches as high as 680MPa, extends Rate 10%-80%, to sum up theoretically zinc-base metal can achieve the basic demand for preparing orthopedic implant.In addition to this, zinc Also there is facilitation for the growth of tendon.Therefore, these prompt us that zinc-base metal is used in the design of type tendon stapler.
Summary of the invention
In view of the above-mentioned problems in the prior art, the object of the present invention is to provide one kind without suturing tendon, can The damage to the tendon broken ends of fractured bone is reduced, and can effectively mitigate suture posterior synechia, the degradable type tendon stapler of good mechanical performance.
To achieve the above object, the present invention provides a kind of degradable type tendon stapler, including locating rod and locking piece, The quantity at least two of middle locating rod, the both ends of the locating rod all have lock hole, pass through for the locking piece, described There is locking mechanism, for locking the relative position between locating rod and locking piece on locking piece.The type tendon stapler is by can Degradation metal material is made, and can finally be fully absorbed by human body.
The locating rod can be horizontally through tendon, and two locating rods can be such as each passed through to the both sides at rupture of tendon Tendon, and the relative position of both sides tendon is locked by the lock hole at locating rod both ends by locking piece, the flesh for being broken both sides Tendon contacts with each other, and there is no need to suture to coincide at rupture of tendon.
Therefore, in order to preferably pass through tendon, the locating rod preferably has acuminous cylindrical bar, and the shape is not only One, than cylinders, elliptical cylinder-shape, the square column type with fillet are all feasible.
The quantity of the locating rod can select 2-6 a as needed, and preferably 4, because of the fixed force phase of 4 locating rods To larger, and convenient for adjusting to degrees of tensions, and 4 quantity is unlikely to the biggish damage of tendon generation.
Further, the locking mechanism is protrusion, the quantity of the protrusion be it is multiple, can pass through in one direction described in Lock hole, and blocked in the opposite direction by the edge of the lock hole.Locking principle above-mentioned is similar in life and commonly uses Band principle.
Preferably, the locking piece is the degradable silk thread with protrusion, particularly preferably degradable metal wire.
In the preferred embodiment of the present invention, the locking piece has axially symmetric convex two-by-two on main shaft It rises, all protrusions all have outwardly extending angle wheel profile, and all angle wheel profiles are in the master along the locking piece At least piecewise or all extend towards identical direction on axis, and the distalmost end of the angle wheel profile is to locking piece master The distance of axis is slightly larger than the edge of the lock hole to the distance of locking piece main shaft." being slightly larger than " described herein is that must expire The foot locking piece can be locked the condition that bore edges block by lock hole in one direction in the other directions.
The shape of the protrusion can be triangle, trapezoidal etc., but from the ease of production for, be directly made into straight The protrusion of linear reversed acanthoid is most preferred.
Further, the locking piece can be one be also possible to it is two or more.In a kind of preferred implementation of the invention In mode, the locking piece is the degradable metal wire for having pairs of linear hangnail, and from the both ends of locking piece main shaft Two sections of linear hangnails being open in opposite directions (having opposite inclined direction) is set respectively inwards, it can be two after U-shaped bending End is each passed through the lock hole of two sides, finally tenses at the both ends of wire together, knots or does not knot and all may be used.Of the invention In another preferred embodiment, the locking piece is separated two degradable metal wires for having pairs of linear hangnail, And the end of wire all has stuck design, can not pass through lock hole, after their front end is each passed through the lock hole of two sides, It tenses respectively again, knots or do not knot and all may be used.
The present invention can change the size of type tendon stapler according to the tendon injury of different parts, length including locating rod, The quantity of diameter and the disconnected place's both sides locating rod of tendon.
Further, the length of the locating rod is preferably 2-4cm, and diameter is preferably 2-3mm, and the diameter of the lock hole is excellent It is selected as 1.5-2mm, the diameter of the locking piece main shaft is preferably 1-1.5mm.
Locating rod needs in the present invention, which play the role of fixedlying positioning, not to be moved, is indeformable, therefore it is preferably by strong Higher degradable metal material is spent to be made.
Preferably, the degradable type tendon stapler is made of Zr-based materials;The Zr-based materials are for pure zinc or containing zinc Mass fraction reaches 90% or more kirsite.
Further, single or Determination of multiple metal elements can be added in above-mentioned kirsite, addible element includes but is not limited to: Magnesium Mg, copper Cu, silver Ag, lithium Li, manganese Mn, strontium Sr, calcium Ca, yttrium Y, gadolinium G, dysprosium Dy;Wherein the quality of every kind of element in the alloy accounts for Than being no more than 5%, and the total mass fraction of each element is no more than 10%;Further, wherein silver, lithium, manganese, strontium, yttrium, gadolinium, dysprosium The respective mass fraction of element is no more than 1%, more preferably less than 0.6%.
In the preferred embodiment of the present invention, the kirsite is binary zinc-containing alloy, such as zinc magnesium alloy, zinc-copper Alloy, manganese alloy, zinc-silver alloy etc.;In another preferred embodiment of the invention, the kirsite is ternary zinc Alloy, such as zinc-magnesium calcium alloy, zinc lithium-copper alloy, zinc lithium calcium alloy, zinc lithium strontium alloy, zinc-magnesium copper alloy.
In better embodiment of the invention, the kirsite is bianry alloy, for example, zinc-copper bianry alloy, wherein The mass fraction of cupric is 1%-3%, further preferably 1.5%-2.5%;Alternatively, zinc-manganese bianry alloy, the wherein matter of manganese Amount score is 0.1-0.6%, further preferably 0.3-0.5%.
In another better embodiment of the invention, the kirsite is ternary alloy three-partalloy containing lithium, such as zinc lithium calcium ternary Alloy or zinc lithium strontium ternary alloy three-partalloy, wherein the sum of mass fraction of lithium calcium or lithium strontium is not more than 1.5%.
The present invention has following advantageous effects:
(1) type tendon stapler of the invention fixes the position at the tendon both ends of fracture, nothing using locating rod and locking piece Need to carry out suture can be such that the tendon broken ends of fractured bone is kept in contact, and reduce the secondary damage to the broken ends of fractured bone, post-operation adhesion can also be effectively relieved, The problems such as tendon function reduction;
(2) present invention has used for reference band principle to position and lock the tendon both ends of fracture, the stapler structure letter of design It is single, it is easy production;
(3) locating rod of the invention is laterally to fix tendon, that is, gives the support force of tendon transverse direction, can avoid longitudinal draw Power, which draws tendon, slits;
(4) compared with degradable magnesium Base Metal, degradable zinc-base metal can provide higher tensile strength, meet in orthopaedics The basic demand of plant can maintain mechanical stability in early stage;
(5) gradually degrade in degradable zinc-containing alloy release zinc ion, magnesium ion, copper ion etc. can provide antibacterial, promote The biological functions such as skeletonization further enhance the superiority of zinc-base metal orthopaedics application.
It is described further below with reference to technical effect of the attached drawing to design of the invention, specific structure and generation, with It is fully understood from the purpose of the present invention, feature and effect.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of a preferred embodiment of type tendon stapler of the present invention;
Fig. 2 is the structural schematic diagram of the another preferred embodiment of type tendon stapler of the present invention;
Fig. 3 is the overall structure diagram of locking piece in Fig. 1 embodiment;
Fig. 4 is the schematic diagram of locking piece protrusion different structure in type tendon stapler of the present invention, and a is linear, and b is triangle Shape, c are trapezoidal;
In attached drawing, 1, locating rod;2, lock hole;3, locking piece;4, locking mechanism;5, tendon;6, stuck key.
Specific embodiment
Embodiment 1
A kind of preferred construction of degradable type tendon stapler of the invention is as shown in Figure 1, the type tendon stapler includes four Locating rod 1 and a locking piece 3, the both ends of locating rod 1 all have lock hole 2, and locking piece 3 is the degradable metal of a root long Silk, has the locking mechanism 4 that arranges in pairs thereon, and locking mechanism 4 is the linear projection (hangnail) for being inclined outwardly extension, and institute The distance for stating distalmost end to the wire of extension relief straight lines is slightly larger than the edge of lock hole 2 to the distance of wire, therefore locks Determine hole 2 to pass through for locking piece 3, and only just may pass through lock hole 2 along the inclined direction of linear projection, opposite direction is It can not pass through, can be locked instead.The principle is similar to common band principle in life.By Fig. 1 and Fig. 3 it is found that this reality It applies the linear projection in example and is divided into two sections, respectively along the position of wire to intermediate portion since the both ends of wire Place is set, beveled is all inside.
As shown in Figure 1, the locating rod 1 is horizontally through tendon at work, therefore, the main structure of locating rod 1 For cylinder, one end has tip, can facilitate piercing tendon.Than cylinders, elliptical cylinder-shape, the square column with fillet The design of shape is also all feasible.Locating rod quantity in the present embodiment is 4, but 2-6 locating rod in a practical situation Quantity is all common, and breaking part both sides can be selected to use the positioning of different number according to the situation of rupture of tendon Bar positions.
Locator 1 first can be inserted through the disconnected place both sides of tendon during installation and need to position by the type tendon stapler in Fig. 1 Position, expose the lock hole 2 at both ends, then one end of locking mechanism 4 passed through to again the tendon on the side of locator 1, paid attention to not Direction hangnail is pulled in tendon, in order to avoid causing biggish damage to tendon, then the both ends of locking mechanism 4 are each passed through this The lock hole 2 of all locators in side tenses the both ends of locking mechanism 4 as needed, makes to break finally along the direction of arrow in figure The tendon both ends split contact with each other, and can knot or not knot after determining position, as long as locking.The advantages of present embodiment, exists As long as in drawing an one metal wire that can tense tendon, and two sides are easy symmetrically.
Certain damage can be generated to tendon in view of locking piece 4 penetrates in tendon, therefore, provide this hair in Fig. 2 again Bright another preferred embodiment uses two separated locking pieces 3 in the embodiment, they can be each passed through tendon two sides Lock hole 2, and the end of locking piece 3 has stuck key 6, can be stuck on lock hole 2, for the end of fixedly locked part 3, But the shortcomings that embodiment, is, the degree that two sides tense is more difficult to control just the same, is easy to produce anisopleual.
Triangle and trapezoidal convex shape are also shown other than above-mentioned linear projection, in Fig. 4, except this with Outside, other any shapes for meeting the principle of the invention are all feasible.
The present invention can change the size of type tendon stapler according to the tendon injury of different parts, length including locating rod, Diameter etc..The length of locating rod 1 is preferably 2-4cm, and diameter is preferably 2-3mm, and the diameter of lock hole 2 is preferably 1.5-2mm, lock The diameter for determining 3 main shaft of part is preferably 1-1.5mm.
Embodiment 2 is used for the degradable stapler of rupture of Achilles tendon healing
Zn-Mn system bianry alloy is selected, (Mn wt0.4%, ultimate tensile strength UTS=260MPa, is bent with Zn-0.4Mn Take intensity YS=160MPa, elongation percentage > 40%) locating rod of diameter 2mm, length 3cm is prepared, and in away from locating rod both ends 3mm Locate the circular hole of one diameter 1.5mm of each preparation and prepares overall length hangnail wire, diameter as lock hole, and with Zn-0.4Mn alloy For 1.25mm.
Appear in use, cutting, position the heel string broken ends of fractured bone, is then respectively successively placed in 3 locating rods to both sides along the broken ends of fractured bone, keeps Spacing 5mm or so, then by hangnail wire, direction shown in arrow sequentially passes through the reserved circular hole in 1 both ends of locating rod along Fig. 1, After passing through whole locating rods, gradually Strain lock determines wire, until the tendon broken ends of fractured bone on both sides contacts with each other.
Embodiment 3 is used for the degradable stapler of rupture of patellar tendon healing
Zn-Cu system bianry alloy is selected, with Zn-2Cu (Cu wt2%, UTS=270MPa, YS=230MPa, elongation percentage > 40%) locating rod of diameter 3mm, length 3cm are prepared, and each circular hole for preparing a diameter 2mm at away from locating rod both ends 3mm Overall length hangnail wire, diameter 1.5mm are prepared as lock hole, and with Zn-2Cu alloy.
In use, knee joint median incision, appears the positioning kneecap tendon broken ends of fractured bone, 4 are respectively successively then placed in both sides along the broken ends of fractured bone Locating rod keeps spacing 5mm or so, and then by hangnail wire, direction shown in arrow sequentially passes through 1 both ends of locating rod along Fig. 1 Reserved circular hole, after passing through whole locating rods, gradually Strain lock determines wire, until the tendon broken ends of fractured bone on both sides contacts with each other.
Embodiment 4 is used for the degradable stapler of rupture of Achilles tendon healing
Zn-Li-Sr system ternary alloy three-partalloy is selected, with Zn-0.4Li-0.1Sr (Li wt0.4%, Sr wt0.1%, UTS= 505MPa, YS=372MPa, elongation percentage > 50%) locating rod of diameter 2mm, length 3cm is prepared, and in away from locating rod both ends The circular hole of one diameter 1.5mm of each preparation prepares overall length hangnail gold as lock hole, and with Zn-0.4Li-0.1Sr alloy at 3mm Belong to silk, diameter 1.25mm.
Appear in use, cutting, position the heel string broken ends of fractured bone, is then respectively successively placed in 3 locating rods to both sides along the broken ends of fractured bone, keeps Spacing 5mm or so, then by hangnail wire, direction shown in arrow sequentially passes through the reserved circular hole in locating rod both ends along Fig. 1, After passing through whole locating rods, gradually Strain lock determines wire, until the tendon broken ends of fractured bone on both sides contacts with each other.
Embodiment 5 is used for the degradable stapler of rupture of patellar tendon healing
Zn-Li-Ca system ternary alloy three-partalloy is selected, with Zn-0.4Li-0.1Ca (Li wt0.4%, Ca wt0.1%, UTS= 500MPa, YS=430MPa, elongation percentage > 15%) locating rod of diameter 3mm, length 3cm is prepared, and in away from locating rod both ends The circular hole of one diameter 2mm of each preparation prepares overall length hangnail metal as lock hole, and with Zn-0.4Li-0.1Ca alloy at 3mm Silk, diameter 1.5mm.
In use, knee joint median incision, appears the positioning kneecap tendon broken ends of fractured bone, 4 are respectively successively then placed in both sides along the broken ends of fractured bone Locating rod keeps spacing 5mm or so, and then by hangnail wire, direction shown in arrow sequentially passes through locating rod both ends along Fig. 1 Reserved circular hole, after passing through whole locating rods, gradually Strain lock determines wire, until the tendon broken ends of fractured bone on both sides contacts with each other.
Embodiment 6
Its chemical property and corrosive nature are tested according to following normal process to zinc-containing alloy selected by the present invention:
(1) electro-chemical test
At room temperature using electrochemical workstation (Autolab, Metrohm, Switzerland), Hank ' s solution In tested.Electro-chemical test is used for using the three-electrode system of platinum electrode-saturated calomel electrode (SCE).To each sample Carry out open circuit potential (Open-circuit potential, OCP) monitoring in 5400 seconds.Electrochemical impedance spectroscopy (Electrochemical impedance spectroscopy, EIS) test is in 10mV, measurement frequency 105To 10-2Hz Under conditions of carry out.Potentiodynamic polarization test (Potentiodynamic polarization is then carried out with the rate of 1mV/s ), test test area 0.2826cm2(φ6mm).Each sample group at least carries out five measurements.By Linear fit and Tafel extrapolation method analyzes the cathode of polarization curve and the corrosion parameter of anode portion, including open circuit potential (OCP), corrosion potential (Ecorr) and corrosion electric current density (icorr)。
1.2 immersion test
Immersion test carries out in 37 DEG C of Hank ' s solution.Pass through pH meter (Mettler during immersion in different time points FiveEasy pH FE20K) recording solution pH value.After removing corrosion product, in electronic balance (XS105, METTLER TOLERDO the weight that sample is measured on) is lost, and measurement sensitivity 0.1mg, every group averagely carries out five measurements.According to following Formula calculates external corrosion rate: C=Δ m/ ρ At, wherein C is the corrosion rate as unit of mm/, and Δ m is weight loss, ρ is the density of material, and A is the surface area initially impregnated, and t is Implantation Time.
The results are shown in Table 1 for partial test.
The electrochemical parameter (37 ± 0.2 DEG C) of pure zinc and kirsite in 1 SBF solution of table
Note: the number in bracket is standard deviation
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that those skilled in the art without It needs creative work according to the present invention can conceive and makes many modifications and variations.Therefore, all technologies in the art Personnel are available by logical analysis, reasoning, or a limited experiment on the basis of existing technology under this invention's idea Technical solution, all should be within the scope of protection determined by the claims.

Claims (10)

1. a kind of degradable type tendon stapler, which is characterized in that including locating rod and locking piece, wherein the quantity of the locating rod At least two, the both ends of the locating rod all have lock hole, pass through for the locking piece, have lock on the locking piece Mechanism is determined, for locking the relative position between the locating rod and the locking piece.
2. degradable type tendon stapler as described in claim 1, which is characterized in that the locating rod is to have acuminous cylinder Shape bar.
3. degradable type tendon stapler as described in claim 1, which is characterized in that the locking mechanism is protrusion, described convex The quantity risen be it is multiple, the lock hole can be passed through in one direction, and in the opposite direction by the side of the lock hole Edge blocks.
4. degradable type tendon stapler as claimed in claim 1 or 3, which is characterized in that the locking piece is with protrusion Degradable silk thread.
5. degradable type tendon stapler as claimed in claim 3, which is characterized in that the locking piece has two-by-two on main shaft Axially symmetric protrusion, all protrusions all have outwardly extending angle wheel profile, and all angle wheel profiles exist At least piecewise or all extend towards identical direction, and the slope profile along the main shaft of the locking piece The distance of the distalmost end of line to the main shaft is slightly larger than the edge of the lock hole to the distance of the main shaft.
6. degradable type tendon stapler as claimed in claim 3, which is characterized in that the shape of the protrusion is triangle, ladder Shape or linear.
7. degradable type tendon stapler as claimed in claim 1 or 3, which is characterized in that the locking piece be one at To the degradable metal wire of linear hangnail, and two sections are arranged respectively inwards from the both ends of the locking piece main shaft and is open in opposite directions Linear hangnail.
8. degradable type tendon stapler as claimed in claim 1 or 3, which is characterized in that the degradable girdle device is by pure zinc Or the mass fraction containing zinc reaches 90% or more kirsite and is made.
9. degradable type tendon stapler as claimed in claim 8, which is characterized in that the degradable girdle device is closed by zinc-magnesium Gold, pltine, zinc-silver alloy or manganese alloy are made.
10. degradable type tendon stapler as claimed in claim 8, which is characterized in that the degradable girdle device is by zinc-magnesium calcium Alloy, zinc lithium-copper alloy, zinc lithium calcium, zinc lithium strontium or zinc-magnesium copper alloy are made.
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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
US20100076556A1 (en) * 2008-09-24 2010-03-25 Intergran technologies, Inc. In-vivo biodegradable medical 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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Title
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