CN109758269A - Prosthese and prosthetic appliance for shoulder joint - Google Patents
Prosthese and prosthetic appliance for shoulder joint Download PDFInfo
- Publication number
- CN109758269A CN109758269A CN201910147605.6A CN201910147605A CN109758269A CN 109758269 A CN109758269 A CN 109758269A CN 201910147605 A CN201910147605 A CN 201910147605A CN 109758269 A CN109758269 A CN 109758269A
- Authority
- CN
- China
- Prior art keywords
- prosthese
- shoulder joint
- sacculus
- shoulder
- development
- Prior art date
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- Pending
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/40—Joints for shoulders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
Abstract
The present invention provides a kind of prostheses and prosthetic appliance for shoulder joint, by the way that prosthese is placed between acromion and humerus head, the rotator cuff of tearing can directly be completely cut off, prevent the bony structure of rotator cuff wound and acromion from generating shock, to relieve pain, undergo reconstruction shoulder-upper arm distance simultaneously, increases the arm of force lifted in shoulder joint, to improve shoulder mobility ability at once.Prosthetic appliance of the invention includes transportation system and prosthese, and the transportation system is used for prosthesis delivery to shoulder joint chamber, so that the prosthese is accommodated between acromion and humerus head, to maintain and/or increase the distance between acromion and humerus head.Prosthese of the invention is the structure of expansible contraction, prosthese can be wherein fixed in shoulder joint chamber by first surface and/or second surface, the resistance to of prosthese can also be enhanced by multilayered structure and puncture performance, the state after development structure observation Using prosthesis can also be passed through.
Description
Technical field
The present invention relates to the field of medical instrument technology, in particular to a kind of prosthese and prosthetic appliance for shoulder joint.
Background technique
Rotator cuff be by supraspinatus, infraspinous muscle, subscapular muscle, teres minor tendon before humerus head, the sleeve that upper, rear is formed
Nesting tendon complex structure has stability, the performance normal activities function such as joint abduction and rotation of maintenance shoulder joint
Vital effect.Rotator cuff tear is common person in middle and old age's shoulder joint illness, is mostly degeneration tendon injury, shows
Prominent symptom is that shoulder arthralgia and joint motion are limited.Rotator cuff prosthesis becomes presently the most effective method, but counterweight
(huge) rotator cuff tear is spent, current operation means or can not directly be repaired, or occurs to tear again after repairing by force, is performed the operation
Effect is still poor.
Therefore, it is necessary to develop a kind of novel prosthese, improve the therapeutic effect of rotator cuff reparation.
Summary of the invention
The purpose of the present invention is to provide a kind of prostheses and prosthetic appliance for shoulder joint, by the way that prosthese is placed in shoulder
It between peak and humerus head, can directly completely cut off the rotator cuff of tearing, prevent the bony structure of rotator cuff wound and acromion from generating shock, from
And relieve pain, while the shoulder that undergoes reconstruction-upper arm distance, increase the arm of force lifted in shoulder joint, to improve shoulder mobility energy at once
Power.Prosthese of the invention is suitable for treatment rotator cuff tear and other shoulder tendon injuries, and can be used for assisting various shoulder joints
Section operation helps to improve the postoperative mechanical condition of shoulder joint.
To achieve the above object, the present invention provides a kind of prosthese for shoulder joint, is the structure of expansible contraction.Its
In, in one embodiment, the prosthese for shoulder joint has the first surface and second surface being oppositely arranged, when the use
After the prosthese expansion of shoulder joint, the first surface is recessed inwardly or plane, and the second surface outwardly protrudes.In another reality
It applies in example, the prosthese for shoulder joint is at least double-layer structure.In another embodiment, the prosthese for shoulder joint
On be provided with development structure, the development structure is made of metal developing material.
Optionally, the cross section semicircular in shape or crescent of the prosthese for shoulder joint after expansion.
Optionally, after the prosthese expansion for shoulder joint, the first surface and the second surface are one
The radius of curvature of cambered surface, the cambered surface is not less than 1.0cm.
Optionally, the radius of curvature of the first surface is not less than 1.5cm, and the radius of curvature of the second surface is not less than
3.0cm。
Optionally, the length range of the prosthese for shoulder joint after expansion is 2.0~8.0cm, and width range is
2.0~8.0cm, altitude range are 0.4~2.5cm.
Optionally, each layer of the prosthese for shoulder joint is answering for one or both of membrane structure and braiding structure
It closes.
Optionally, the internal layer of the prosthese for shoulder joint is membrane structure.
Optionally, the strength of materials of the outer layer of the prosthese for shoulder joint is higher than the prosthese for shoulder joint
The strength of materials of internal layer.
Optionally, in the prosthese for shoulder joint two layers of arbitrary neighborhood by hot-melt adhesive paste or by binder company
It connects, alternatively, the prosthese for shoulder joint is formed by multi-layer co-extruded blow molding processing.
Optionally, the development structure setting is in the prosthese for shoulder joint, alternatively, the development structure setting
In the outer surface of the prosthese for shoulder joint.
Optionally, the development structure is a development coating, and metal developing material vapor deposits or be sprayed on the use
In forming the development coating on the outer surface of the prosthese of shoulder joint.
Optionally, metal developing material hot insert forms the development structure on the prosthese for shoulder joint.
Optionally, the development structure is multiple, is arranged along the edge of the prosthese for shoulder joint.
Optionally, the development structure is dotted or arc-shaped flaky.
Optionally, the development structure is multiple, and equidistantly distributed is in the prosthese for shoulder joint.
Optionally, the development structure is strip, and the length direction of the development structure is described for shoulder joint
Prosthese length direction.
To achieve the above object, the present invention also provides a kind of prosthetic appliances, including described in transportation system and any of the above-described
Prosthese;Wherein, the transportation system is used for the prosthesis delivery for being used for shoulder joint to predetermined position.
Optionally, the transportation system includes delivery conduit and drive rod;The inside of the prosthese for shoulder joint is set
It is equipped with sealing element, while the proximal end of the prosthese for shoulder joint is provided with interconnecting piece, the interconnecting piece has and is used for shoulder
The hollow channel being connected to inside the prosthese in joint;Wherein:
The distal end of the delivery conduit is for detachably connected with the interconnecting piece, to be used for shoulder joint described in push
Prosthese;The drive rod is movably inserted into the delivery conduit and passes through the interconnecting piece and connect with the sealing element, described
Drive rod is for driving the sealing element to be at least partially into the hollow channel, so that sealing element closure is described hollow logical
Road.
Optionally, the region that the drive rod is connected with the sealing element is weakness zone, the pole of the weakness zone
The ultimate strength that intensity is less than the sealing element and the drive rod is limited, so that the drive rod is under external force in described thin
It is broken at weak-strong test, and separates the drive rod mutually with the sealing element.
Compared with prior art, have below provided by the present invention for the prosthese of shoulder joint and prosthetic appliance beneficial to effect
Fruit;
The first, after prosthese of the invention is placed in shoulder joint chamber, shoulder can be prevented by expanding the rotator cuff that directly isolation is torn
The bony structure of wound and acromion of tucking inside the sleeve generates shock, to relieve pain, while undergo reconstruction between acromion and humerus head away from
From increasing the arm of force lifted in shoulder joint, improve shoulder mobility ability, and prosthese of the invention is especially suitable for treatment
Rotator cuff tear and other shoulder tendon injuries, and can be used for assisting various Shoulder surgeries, help to improve shoulder joint art
Mechanical condition afterwards.Also, prosthese of the invention is after expansion, and first surface, which is recessed inwardly, can coat humerus cephalic par, and/
Or second surface outwardly protrudes can be bonded acromion end, in this way can effective fixed fae body, avoid postoperative prosthese from being displaced
Even fall off.Meanwhile prosthese of the invention is fixed without foreign components (being such as anchored fixed device), only passes through self-forming
Surface and corresponding bone structure carry out cooperation and can realize that positioning is fixed, be not only simple in structure, and wound is also small, be conducive to
Improve surgical result.
The second, prosthese of the invention is at least double-layer structure, enhances the puncture resistance energy of prosthese, can effectively prevent prosthese
It is worn out after being implanted into human body by the spur in shoulder joint chamber, and during arm motion, humerus head can also be reduced to prosthese
Caused by wear, it is ensured that the postoperative reliability used of prosthese.
It is additionally provided with development structure in third, prosthese of the invention, is conducive to doctor and passes through X-ray to hurtless measure after surgery
Check state of the prosthese in shoulder joint, avoid it is postoperative checked by way of operating on, to avoid causing two to patient
Secondary injury improves the effect of operative treatment.
Detailed description of the invention
Fig. 1 is the schematic diagram being placed in prosthese between acromion and humerus of one embodiment of the invention;
Fig. 2 a is the perspective view of the prosthese of one embodiment of the invention;
Fig. 2 b is the main view of prosthese shown in Fig. 2 a;
Fig. 2 c is that the prosthese of one embodiment of the invention forms the schematic diagram being curved concave inward before structure;
Fig. 2 d is the sectional view of the inner cavity of the prosthese of one embodiment of the present invention;
Fig. 3 a is the schematic diagram that the first development structure of arc is arranged on the prosthese of one embodiment of the invention;
Fig. 3 b is the schematic diagram that the second development structure of strip is arranged on the prosthese of one embodiment of the invention;
Fig. 4 is the schematic diagram that wave-shaped trench is provided on the prosthese of one embodiment of the invention.
Fig. 5 a and Fig. 5 b are the schematic diagram that prosthese realizes sealing in the prosthetic appliance of one embodiment of the invention respectively;
Fig. 5 c is the schematic diagram that prosthese is mutually separated with transportation system in the prosthetic appliance of one embodiment of the invention.
10- rotator cuff sacculus;10 '-balloon structures;11- first surface;12- second surface;13- internal layer;14- outer layer;15-
First development structure;The development structure of 16- second;17- groove;18- interconnecting piece;19- sealing element;20- acromion;30- humerus head;
40- transportation system;41- delivery conduit;42- drive rod.
Specific embodiment
To keep the purpose of the present invention, advantages and features clearer, the present invention is made below in conjunction with attached drawing further detailed
Explanation.It should be noted that attached drawing is all made of very simplified form and using non-accurate ratio, only to convenient, apparent
The purpose of the ground aid illustration embodiment of the present invention.
In the following description, a large amount of concrete details are given so as to provide a more thorough understanding of the present invention.So
And it is obvious to the skilled person that the present invention may not need one or more of these details and be able to
Implement.In other examples, in order to avoid confusion with the present invention, for some technical characteristics well known in the art not into
Row description.
As used in the specification and the appended claims, term " first ", " second " are used for description purposes only,
It is not understood to indicate or imply relative importance or implicitly indicates the quantity of indicated technical characteristic.It limits as a result,
There is the feature of " first ", " second " to can explicitly or implicitly include one or more of the features.It is retouched in of the invention
In stating, unless otherwise indicated, the meaning of " plurality " is two or more.In addition, in the following description, for the ease of retouching
It states, also uses " proximal end " and " distal end ";" proximal end " refers to that, apart from the closer one end of transportation system operator, " distal end " is span
From the farther away one end of transportation system operator.
Core of the invention thought is to provide a kind of prosthese for shoulder joint, for being delivered to human body shoulder joint
Shoulder joint chamber (is placed between acromion and humerus head), to maintain and/or increase the distance between acromion and humerus head, thus directly
The rotator cuff for completely cutting off tearing is prevented the bony structure of rotator cuff wound and acromion from generating shock, is relieved pain with this, undergone reconstruction simultaneously
The distance between acromion and humerus head increase the arm of force lifted in shoulder joint, improve shoulder mobility ability.The prosthese of the present embodiment
It suitable for treatment rotator cuff tear and other shoulder tendon injuries, and can be used for assisting various Shoulder surgeries, help to change
The kind postoperative mechanical condition of shoulder joint, improves therapeutic effect.
In the present invention, the prosthese for shoulder joint is the structure of expansible contraction.
In one embodiment, the prosthese for shoulder joint has the first surface and second surface being oppositely arranged, institute
First surface is stated for being arranged towards humerus head, the second surface is used to be arranged towards acromion.And shoulder joint is used for when described
Prosthese after the expansion of shoulder joint chamber, the first surface is recessed inwardly or for plane, and the preferably described first surface is an indent
Face, the second surface outwardly protrude, preferably an arcuate surface.Here, the first surface is formed to the inner recess of prosthese
Inner concave prevents prostheses migration to wrap up humerus cephalic par, and the second surface forms evagination to the external protrusion of prosthese
Face further prevents prostheses migration so as to be bonded with acromion, and fixed effect is more preferable." being recessed inwardly " refers to first
It is recessed in entire surface to the direction close to prosthese central point, without considering whether its surface is smooth;" outwardly convex " is
Refer to second surface on the whole to the direction protrusion far from prosthese central point, without considering whether its surface is smooth;" the indent
Face ", which refers to, does section by any point on first surface, and section is located at the inside of first surface;" arcuate surface " refer to through
It crosses any point on second surface and does section, section is located at the outside of second surface.
In another embodiment, it is contemplated that prosthese needs bear biggish power in shoulder joint chamber, and shoulder joint is mobile
Also abrasion is had, is easy to puncture prosthese, for this purpose, the prosthese for shoulder joint is more preferably at least double-layer structure, is done so not
Only the intensity of prosthese is good, and the resistance to performance that punctures of prosthese might as well.
In another embodiment, development structure is provided on the prosthese for shoulder joint, the development structure is by gold
Belong to developing material to be made.And then the information such as postoperative shape, the position that prosthese is observed under X-ray can be facilitated by structure of developing, with
This is avoided postoperative carry out second operation, and reduction is injured caused by patient.
Next the prosthese for shoulder joint of the invention is further described in conjunction with figure and specific embodiment.
Fig. 1 is the schematic diagram being placed in prosthese between acromion and humerus of one embodiment of the invention.As shown in Figure 1, described
Prosthese is specially rotator cuff sacculus 10, and in actual operation, the rotator cuff sacculus 10 is implanted between acromion 20 and humerus head 30, is used
To maintain and/or increase the distance between acromion 20 and humerus head 30.In addition, the rotator cuff sacculus 10 has inner cavity, it is described interior
Chamber is used to be passed through the gas or liquid of full rotator cuff sacculus 10, wherein water, physiological saline, simulated body fluid or contrast agent etc. may be selected
Full rotator cuff sacculus 10.The material of the rotator cuff sacculus 10 can be biodegradable medical macromolecular materials, or
Not biodegradable medical macromolecular materials.If 10 non-degradable of rotator cuff sacculus, will be stayed in vivo as long-term implant
It sets, and subsequent needs to carry out second operation taking-up., whereas if rotator cuff sacculus 10 is degradable, then rotator cuff sacculus 10 is planted for a long time
It is final that biodegrade realization noresidue occurs after entering human body, avoid second operation from taking out, the injury caused by patient in this way is small.
In the embodiment of the present invention, not biodegradable medical macromolecular materials can be selected from polyesters, polyamide, polyvinyl chloride, nylon
One of elastomer and polyurethanes elastic rubber or multiple combinations;Biodegradable medical macromolecular materials can be selected from
Polylactic acid, polycaprolactone, polylactide-caprolactone copolymer, polypeptide, polyaminoacid, poly- 3- hydroxyalkanoate, chitin and
One of PBS (poly butylene succinate) or multiple combinations.
Fig. 2 a is the perspective view of the prosthese of one embodiment of the invention, and Fig. 2 b is the main view of prosthese shown in Fig. 2 a.Such as figure
It shown in 2a and Fig. 2 b, and combines for Fig. 1, the rotator cuff sacculus 10 has the first surface 11 and second surface being oppositely arranged
12, the first surface 11 is used for towards humerus head 30, and the second surface 12 is used for towards acromion 20.The embodiment of the present invention
In, at least one of the first surface 11 and second surface 12 the consolidating in shoulder joint chamber for realizing rotator cuff sacculus 10
It is fixed, prevent rotator cuff sacculus 10 to be displaced.Specifically, the first surface 11 can be recessed inwardly and coat the end of humerus head 30
Portion;Alternatively, the second surface 12 can outwardly protrude and be bonded the end of acromion 20;Or the first surface 11 is inwardly
It is recessed when coating the end of humerus head 30, the second surface 12 also outwardly protrudes the end of fitting acromion 20 simultaneously;These
Mode can fix rotator cuff sacculus 10, prevent rotator cuff sacculus 10 from sliding in shoulder joint chamber, and rotator cuff sacculus 10 is not necessarily to
Foreign components (being such as anchored fixed device) are fixed, and are only cooperated just by the surface of self-forming with corresponding bone structure
Self-retaining can be achieved, be not only simple in structure, and wound is also small, be conducive to improve surgical result.
In one embodiment, the rotator cuff sacculus 10 after expansion can be ball-crown body (not shown), that is, the rotator cuff sacculus
10 cross section semicircular in shape, at this point, first surface 11 is plane, and second surface 12 is arc surface.In other embodiments,
The rotator cuff sacculus 10 after expansion can be also peltate (a and Fig. 2 b referring to fig. 2), also that is, the cross section of the rotator cuff sacculus 10 is in
It is crescent, at this point, first surface 11 and second surface 12 are arc surface.However, first surface 11 and second surface 12 are unlimited
In for arc surface, it is also possible to non-arc surface, including class cambered surface.It will be appreciated that the shape and size of the first surface 11 are main
It is arranged according to the shape and size of patient's humerus head, so that first surface 11 can match with humerus cephalic par, certainly
The shape and size of the second surface 12 are also mainly configured according to the shape and size of patient's acromion, make second surface 12
It can be sufficiently bonded with acromion end, fixed effect is more preferable.
Further, when the first surface 11 is the cambered surface of indent, the radius of curvature of the first surface 11 is optional
For not less than 1.0cm, further, when the first surface 11 is arc surface, radius of curvature is chosen as being not less than
1.5cm.In addition, the radius of curvature of the second surface 12 is also chosen as not when the second surface 12 is the cambered surface of evagination
Less than 1.0cm, such as when second surface 12 is arc surface, radius of curvature is optional to be not less than 3.0cm.In these radius of curvature models
In enclosing, the rotator cuff sacculus 10 of the present embodiment can satisfy the demand of different Skeletal sizes, ages substantially.And in a demonstration
In the embodiment of property, after expansion, length range is chosen as 2.0~8.0cm to the rotator cuff sacculus 10, and width range is chosen as
2.0~8.0cm, altitude range are chosen as 0.4~2.5cm, whole after rotator cuff sacculus 10 can be made to expand in these size ranges
The rotator cuff that body size meets different crowd repairs needs.
Further, the rotator cuff sacculus 10 after expansion preferably matches with shoulder joint chamber, makes sacculus so on the whole
It can be bonded and fill shoulder joint chamber, be slid after surgery to more efficiently prevent from rotator cuff sacculus 10, therefore, sacculus is in shoulder
After the full expansion of articular cavity, rotator cuff sacculus 10 can sufficiently be bonded acromion 20, coronoid process, ligamentum coracoacromiale, the upper arm around shoulder joint chamber
The institutional frameworks such as bone 30, tendon of supraspinatus muscle, and realize that positioning is fixed with first surface 11 therein and/or second surface 12, from
And sacculus is effectively prevented from after surgery in reconditioning, it is slipped with shoulder mobility.Therefore, rotator cuff sacculus 10 of the invention
After expansion, meet the physiology configuration for the shoulder joint chamber that human body is formed by acromion, humerus head and oversleeve sample tendon complex, Gu
It is good to determine effect.
The preparation method of the rotator cuff sacculus 10 is not especially limited, and can be blow molding, is also possible to other moldings
Mode.Here, it is preferred that blow molding, processing cost is low, and processing effect is good.Blow molding process includes extrusion-blown modling and injection molding blow molding etc.
Mode.With in a unrestricted preparation method, preparation process be may is that
Balloon material is heated by screw rod and is squeezed out first, obtains the sacculus initial configuration of a tubulose, later, sacculus is initial
Structure be put into blow mold heated, sizing of pressurizeing, finally obtain the rotator cuff sacculus 10 of required shape.Wherein, preferred screw rod
Diameter≤50mm reduces cost, while the heating temperature of blow mold is preferred to reduce loss of the process to balloon material
Same or similar with the fusing point of balloon material, if the heating temperature of blow mold can be set as 140 DEG C~180 DEG C, doing so can be mentioned
The bonding strength for rising sacculus edge, avoids leaking.It, can be primary by blow mold in sacculus forming process in the present invention
Shown in the rotator cuff sacculus 10 or Fig. 2 c of shape needed for sizing obtains, by newly-designed blow mold to initial sacculus knot
Structure 10 ' carries out secondary sizing and obtains the rotator cuff sacculus 10 of required shape.
Further, the rotator cuff sacculus 10 be preferably two layers or more structure, but including and be not limited to two layers.When rotator cuff ball
When capsule 10 is multilayer, the intensity of sacculus can be significantly increased, so that sacculus is withstood more force in shoulder joint chamber, while can also
The puncture resistance ability for enhancing sacculus, prevents sacculus from being punctured after being implanted into human body by the spur in shoulder joint chamber, and can also enhance
The repellence of humerus head abrasion sacculus in arm active procedure, therefore resistance to the puncturing property and wear resistance of multilayer sacculus are good.Such as
Shown in Fig. 2 d, it is internal layer 13 and outer layer 14 respectively, between outer layer 14 and internal layer 13 that the rotator cuff sacculus 10, which is specially double-layer structure,
It can be connected, can also be connected by binder by heat fusing, or be integrally formed by multi-layer co-extruded blow molding mode.If shoulder
Sacculus 10 of tucking inside the sleeve selects degradation material, and outer layer 14 is preferably connect by heat fusing mode with internal layer 13 or multi-layer co-extruded is blow molded into
Type, such outer layer 14 are combined effect good with internal layer 13.Also, the material of internal layer 13 and outer layer 14 can be identical or not identical, and
Layers of material can be it is degradable or nondegradable, but the wall thickness of outer layer 14 and internal layer 13 can according to actual clinical demand into
Row setting, that is not required by the present invention.In addition, in multi-layer co-extruded blow molding process, the preferred material melting point of each layer of sacculus
It is same or similar, help to enhance the bonding strength between each layer.The present invention is not especially limited the thickness of each layer of sacculus, can
Each layer is selected to account for the percentage of sacculus overall thickness not less than 5%.In an exemplary embodiment, the rotator cuff sacculus 10 is two layers
Structure, wherein the material of internal layer 13 selects polylactide-polycaprolactone co-polymer, optionally, polylactide and polycaprolactone
Content ratio is 7:3, and in addition the material of outer layer 14 is also polylactide-polycaprolactone co-polymer, and for polylactide and is gathered in oneself
The content ratio of ester is 5:5, while internal layer 13 can be identical with the thickness of outer layer 14.
In the embodiment of the present invention, each layer of the rotator cuff sacculus 10 can be formed by film preparation, can also be woven by braided wires
It forms, wherein film has preferable sealing function, can prevent the full liquid leakage of balloon interior, and plural layers can also
Enhance the puncture resistance ability of sacculus.Certainly, for single layer sacculus, braiding structure can also effectively promote sacculus intensity,
Enhance the puncture resistance energy of sacculus.Preferably, the internal layer of the rotator cuff sacculus is membrane structure, and the structure of other layers does not limit especially
System, can be membrane structure, be also possible to the compound of braiding structure or braiding structure and membrane structure.It is furthermore preferred that the shoulder
The strength of materials of the outer layer of sleeve sacculus 10 is higher than the strength of materials of internal layer, and the strength of materials is not limited to modulus of shearing, tensile strength etc..
It is furthermore preferred that each layer choosing of the rotator cuff sacculus is from biodegradable material, and all layers of degradation time is configured as not
Together, as from inside to outside, each layer is successively degraded, and can preferably be controlled the degradation rate of sacculus in this way, be realized better therapeutic effect.
Further, the rotator cuff sacculus 10 further preferably has developability, is on the one hand conducive in art by X-ray examination
Situations such as implantation position well-formedness of the rotator cuff sacculus 10 in shoulder joint chamber, full expansion state, on the other hand patient after surgery
Rehabilitation during, making doctor that can check rotator cuff sacculus 10 by X-ray hurtless measure, whether breakage is let out in shoulder joint chamber
Whether correct, sacculus deformation situation of dew, balloon position etc., avoids passing through the invasive Operations Research sacculus state of surgery, to avoid
It is postoperative that secondary injury is caused to patient.In the embodiment of the present invention, it is provided in the outer surface of the rotator cuff sacculus 10 or cavity wall aobvious
Shadow structure, the development structure are made of developing materials such as metal, metal oxide or metal salts, and developing material can be selected from
BaSO4、Bi2O3、(BiO)2CO3, one of developing materials such as BiOCl, W, WC, Mg, Fe, Nd, Zn and Zr or multiple combinations.It is special
Not, when sacculus selects biodegradable medical macromolecular materials, the development structure selects magnesium-based, zinc-base and iron-based etc.
One of biological medical degradable metal material or multiple combinations.Optionally, the development structure is in dotted, blocky or piece
Shape, the present invention do not limit the form of development structure particularly.Preferably, the development structure is multiple.
In some embodiments, for multiple development structures preferably along the edge distribution of rotator cuff sacculus 10, benefit is to grasp
Author is under X-ray by development observation analysis balloon profile, the expanded state of multiple development structures.In some embodiments, more
A development preferred equidistantly distributed of structure is tied under X-ray by multiple developments on the outer surface of rotator cuff sacculus convenient for operator
The development observation analysis sacculus bending deformation state of structure, expanded state etc..
As shown in Figure 3a, multiple first development structures 15, and multiple first can be set on the outer surface of rotator cuff sacculus 10
Structure 15 of developing such as can be distributed at four angles of sacculus along the edge distribution of rotator cuff sacculus 10, and the first development structure
15 be preferably dotted or arc-shaped flaky.Again as shown in Figure 3b, multiple second can also be arranged on the outer surface of rotator cuff sacculus 10
Develop structure 16, multiple second development, 16 equidistantly distributeds of structure, and the second development structure 16 preferably strip, and second
The length direction for structure 16 of developing is the length direction (i.e. axis direction) of rotator cuff sacculus 10, at this point, can be convenient for operator in X-ray
Under by second development structure 16 development observation analysis sacculus bending deformation state and expanded state.And when practical application,
Multiple first development structures 15 and multiple second development structures 16 can be set simultaneously on sacculus, and arranged in the foregoing manner, from
And obtain corresponding development effect.In the embodiment of the present invention, the first development structure 15 can be hot in sacculus forming process
It is embedded in the wall of rotator cuff sacculus 10, the second development structure 16 is in a manner of being vapor-deposited or spray on sacculus outer surface
Form development coating.It is wherein vapor-deposited or is sprayed the development structure that can realize low thickness on sacculus, avoids development structure
The expansion and folding of rigidity effects sacculus, and the damage to sacculus can also be reduced, avoid the intensity for influencing sacculus.In addition, hot
Inlaying is that prefabricated development structure is embedded in the balloon wall under heated condition on the sacculus of heating, then cooling and fixed
And realize, development structure can also be inlayed in the wall of multilayer sacculus certainly.The advantages of hot insert embedding mode is simple process, but not
It can avoid ground balloon wall is caused to damage, reduce the intensity of sacculus, degradable sacculus is especially corresponded to, during hot insert is embedding
Heating can accelerate sacculus to degrade, and reduce balloon material molecular weight and intensity.
Further, the rotator cuff sacculus 10 further preferably carries drug, as sacculus at least partly outer surface on be arranged
There is drug, drug here can be used for promoting to damage tendon and restore or relieve the pain analgesia etc., to promote the tendon growth of tearing extensive
Multiple or mitigation patient pain.Such as diclofenac diethylamine, fentanyl, Etorphine alpha-2 receptor agonist beauty can be selected in the drug
Hold in the palm miaow pyridine, droperidol, rely on amidine ester, Vecuronium Bromide ethocaine, tetracaine hydrochloride, lidocaine hydrochloride with
And other have one of drug of growth factor or the analgesic effect that relieves the pain for promoting tendon growth recovery or multiple combinations.?
In some embodiments, the drug is applied directly on at least partly outer surface of sacculus;In some embodiments, such as Fig. 4 institute
Show, groove 17 is provided on the outer surface of sacculus, and drug is just accommodated in groove 17.Drug is carried by groove 17, it can
Increase drug load, preferably realizes drug therapy, but the shape of groove 17, size can be according to the drugloading rates of clinical demand
It is adjusted, in addition, the shape of groove 17 is also not limited to shape shown in Fig. 4, when practical application, the shape of groove 17, width
Degree, depth etc. can be adjusted according to actual demands such as diffusion rates after drug dose, medicament contact blood vessel.This hair embodiment
In, the groove 17 can be linear, be also possible to shaped form, or can also be the combination of curve and straight line, wherein bent
Line style may be designed to waveform, and groove 17 can also be multiple, and multiple grooves 17 can be spaced setting, is also possible to intersection and sets
It sets, the specific arrangement present invention is not construed as limiting, and groove 17 can be processed by the modes such as laser ablation or mold thermoforming
It realizes.
With continued reference to Fig. 2 a and Fig. 2 b, the proximal end of the rotator cuff sacculus 10 has interconnecting piece 18, and the interconnecting piece 18 has
The hollow channel being connected to balloon interior, and in actual use, the interconnecting piece 18 be used for it is detachably connected with transportation system,
And sacculus is pushed by transportation system, realize the implantation of sacculus.Specifically, in surgical procedure, pass through transportation system first
The rotator cuff sacculus 10 of folded state is established into percutaneous puncture channel by the percutaneous passage of shoulder joint mirror or individually and is sent into shoulder joint
Chamber, and folded state includes compressive state;Later, behind the position for determining rotator cuff sacculus 10, transportation system by outer injectors, fill
The full liquid that device or other full devices provide that is full of is sent into rotator cuff sacculus 10, keeps rotator cuff sacculus 10 full and realizes expansion (this
In the process, expanded state, bending state of sacculus etc. can be observed by the developing performance of sacculus), and after sacculus is full, then into
One step closes rotator cuff sacculus 10;Finally, transportation system is separated with rotator cuff sacculus 10 and withdraws from human body.
Subsequently refering to Fig. 5 a to Fig. 5 c, the embodiment of the present invention also provides a kind of transportation system 40, the transportation system 40 packet
Delivery conduit 41 is included, the distal end of the delivery conduit 41 is for detachably connected with interconnecting piece 18, and delivery conduit 41 is interior
Chamber is connected with the inner cavity of sacculus.It, can be by full liquid by delivery conduit 41 after delivery conduit 41 is connect with interconnecting piece 18
It is sent directly into rotator cuff sacculus 10 and realizes the full of sacculus, and sacculus can also be pushed by delivery conduit 41, realize sacculus in vivo
Release.The connection type of delivery conduit 41 and interconnecting piece 18 can be snap-on, buckle, screw thread etc. and be detachably connected.
Preferably, the rotator cuff sacculus 10 further includes sealing element 19, which is arranged in the inner cavity of rotator cuff sacculus 10
In, and after rotator cuff sacculus 10 fills expansion in vivo, the sealing element 19 prevents full liquid for blocking the interconnecting piece 18
Body outflow.Optionally, the sealing element 19 is check valve made of high molecular material, and check valve can be set in interconnecting piece 18
In hollow channel, may also be arranged at the import or export of hollow channel, and the material of check valve can be it is biodegradable or
It is not biodegradable.Optionally, the sealing element 19 is also possible to be at least partially inserted into the interconnecting piece 18 under outer power drive
And it is tightly connected with interconnecting piece 18.
Preferably, the transportation system 40 further includes drive rod 42, and the drive rod 42 is movably inserted into delivery conduit
41 and pass through the interconnecting piece 18 and the sealing element 19 it is separably attached.As shown in Figure 5 a, expand when rotator cuff sacculus 10 is full
Zhang Hou, the drive rod 42 is for driving the sealing element 19 to be at least partially into the hollow channel, so that the sealing element
19 block the hollow channel.Here, the sealing element 19 can be enclosed in the inside of rotator cuff sacculus 10 in advance, and then operator can be
Proximal end pulls drive rod 42, so that sealing element 19 is entered interconnecting piece 18 and realizes sealing, interconnecting piece 18 here can lead to sealing element 19
Interference fit, which is realized, to be tightly connected, and such mode is easy to operate, and sealing effect might as well.
Preferably, the region that the drive rod 42 is connected with sealing element 19 is configured to weakness zone, the weak area
The ultimate strength in domain is less than the ultimate strength of the sealing element 19 and drive rod 42, so that the drive rod 42 and sealing element 19 exist
It is broken at the weakness zone under external force, to make sealing element 19 separate with drive rod 42, as shown in Figure 5 b.Finally,
As shown in Figure 5 c, after rotator cuff sacculus 10 fills expansion in vivo and realizes sealing, by drive rod 42 and delivery conduit 41 along
Arrow direction withdraws from human body together.
The last embodiment of the present invention also provides a kind of prosthetic appliance, is used for Shoulder surgery comprising 40 He of transportation system
Rotator cuff sacculus 10, the transportation system 40 are used to the rotator cuff sacculus 10 being delivered to shoulder joint chamber, accommodate rotator cuff sacculus 10
Between acromion 20 and humerus head 30, to maintain and/or increase the distance between acromion 20 and humerus head 30.
Present pre-ferred embodiments as described above, but be not limited to the above embodiments disclosed range, it is any in the application
Made transformation, within the scope of the present invention within scope of disclosure.
To sum up, after rotator cuff sacculus of the invention is placed in shoulder joint chamber, can be prevented by expanding the rotator cuff that directly isolation is torn
Only the bony structure of rotator cuff wound and acromion generates shock, to relieve pain, while undergoing reconstruction between acromion and humerus head
Distance, increase the arm of force lifted in shoulder joint, improve shoulder mobility ability, and prosthese of the invention especially suitable for
Rotator cuff tear and other shoulder tendon injuries are treated, and can be used for assisting various Shoulder surgeries, help to improve shoulder joint
Save postoperative mechanical condition.Also, rotator cuff sacculus of the invention is after expansion, and first surface, which is recessed inwardly, can coat humerus head
End and/or second surface, which outwardly protrude, can be bonded acromion end, can effectively fix rotator cuff sacculus in this way, avoid postoperative
Rotator cuff sacculus is displaced or even falls off.Meanwhile rotator cuff sacculus of the invention is without foreign components (being such as anchored fixed device)
It is fixed, only carrying out cooperation with corresponding bone structure by the surface of self-forming can realize that positioning is fixed, not only structure letter
It is single, and wound is also small, is conducive to improve surgical result.
Rotator cuff sacculus of the invention is at least double-layer structure, enhances the puncture resistance energy of rotator cuff sacculus, can effectively prevent
Rotator cuff sacculus is worn out after being implanted into human body by the spur in shoulder joint chamber, and during arm motion, can also reduce humerus
Head is worn caused by rotator cuff sacculus, it is ensured that the postoperative reliability used of rotator cuff sacculus.
It is additionally provided with development structure on rotator cuff sacculus of the invention, is conducive to doctor and passes through X-ray to hurtless measure after surgery
Check state of the rotator cuff sacculus in shoulder joint, avoid it is postoperative checked by way of operating on, to avoid making patient
At secondary injury, the effect of operative treatment is improved.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hair
Any change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claims
Range.
Claims (25)
1. a kind of prosthese for shoulder joint is the structure of expansible contraction, which is characterized in that the prosthese for shoulder joint
With the first surface and second surface being oppositely arranged, and after the prosthese expansion for shoulder joint, the first surface
It is recessed inwardly or for plane, the second surface is outwardly protruded.
2. the prosthese according to claim 1 for shoulder joint, which is characterized in that described after expansion is for shoulder joint
The cross section semicircular in shape or crescent of prosthese.
3. the prosthese according to claim 1 or 2 for shoulder joint, which is characterized in that when the vacation for shoulder joint
After body expansion, the first surface and the second surface are a cambered surface, and the radius of curvature of the cambered surface is not less than 1.0cm.
4. the prosthese according to claim 3 for shoulder joint, which is characterized in that the radius of curvature of the first surface is not
Less than 1.5cm, the radius of curvature of the second surface is not less than 3.0cm.
5. the prosthese according to claim 1 or 2 for shoulder joint, which is characterized in that described for shoulder joint after expansion
The length range of the prosthese of section is 2.0~8.0cm, and width range is 2.0~8.0cm, and altitude range is 0.4~2.5cm.
6. the prosthese according to claim 1 or 2 for shoulder joint, which is characterized in that the prosthese for shoulder joint
At least double-layer structure.
7. the prosthese according to claim 1 or 2 for shoulder joint, which is characterized in that the prosthese for shoulder joint
On be provided with development structure, the development structure is made of metal developing material.
8. a kind of prosthese for shoulder joint is the structure of expansible contraction, which is characterized in that the prosthese for shoulder joint
At least double-layer structure.
9. the prosthese according to claim 8 for shoulder joint, which is characterized in that the prosthese for shoulder joint it is each
Layer is the compound of one or both of membrane structure and braiding structure.
10. the prosthese according to claim 9 for shoulder joint, which is characterized in that the prosthese for shoulder joint
Internal layer is membrane structure.
11. the prosthese according to claim 8 for shoulder joint, which is characterized in that the prosthese for shoulder joint
The strength of materials of outer layer is higher than the strength of materials of the internal layer of the prosthese for shoulder joint.
12. being used for the prosthese of shoulder joint according to any one of claim 8-11, which is characterized in that described to be used for shoulder joint
It is connected by hot-melt adhesive paste or by binder for two layers of arbitrary neighborhood in the prosthese of section, alternatively, the prosthese for shoulder joint
It is processed and is formed by multi-layer co-extruded blow molding.
13. being used for the prosthese of shoulder joint according to any one of claim 8-11, which is characterized in that described to be used for shoulder joint
Development structure is provided on the prosthese of section, the development structure is made of metal developing material.
14. a kind of prosthese for shoulder joint is the structure of expansible contraction, which is characterized in that the vacation for shoulder joint
Development structure is provided on body, the development structure is made of metal developing material.
15. the prosthese according to claim 14 for shoulder joint, which is characterized in that the development structure setting is described
For in the prosthese of shoulder joint, alternatively, the development structure setting is in the outer surface of the prosthese for shoulder joint.
16. the prosthese according to claim 15 for shoulder joint, which is characterized in that the development structure is that a development applies
Layer, and metal developing material vapor is deposited or is sprayed on and forms the development painting on the outer surface for the prosthese of shoulder joint
Layer.
17. the prosthese according to claim 15 for shoulder joint, which is characterized in that metal developing material hot insert is embedded in institute
It states and forms the development structure in the prosthese for shoulder joint.
18. the prosthese according to claim 14 for shoulder joint, which is characterized in that the development structure is multiple, edge
The edge arrangement of the prosthese for shoulder joint.
19. the prosthese according to claim 18 for shoulder joint, which is characterized in that the development structure is dotted or arc
Shape sheet.
20. the prosthese according to claim 14 for shoulder joint, which is characterized in that the development structure be it is multiple, etc.
Spacing is distributed in the prosthese for being used for shoulder joint.
21. the prosthese according to claim 20 for shoulder joint, which is characterized in that the development structure is strip,
And the length direction of the development structure is the length direction of the prosthese for shoulder joint.
22. the prosthese of shoulder joint is used for described in any one of 4-21 according to claim 1, which is characterized in that described to be used for shoulder
The prosthese in joint is at least double-layer structure;
The prosthese for shoulder joint has the first surface and second surface being oppositely arranged, and for shoulder joint described in
After prosthese expansion, the first surface is recessed inwardly or plane, and the second surface outwardly protrudes.
23. a kind of prosthetic appliance, which is characterized in that including transportation system;And such as use of any of claims 1-7
In the prosthese of shoulder joint, perhaps as described in any one of claim 8-13 for the prosthese of shoulder joint or as right is wanted
Seek the prosthese that shoulder joint is used for described in any one of 14-22;Wherein, the transportation system is used for the shoulder joint that is used for
Prosthesis delivery is to predetermined position.
24. prosthetic appliance according to claim 23, which is characterized in that the transportation system includes delivery conduit and driving
Bar;The prosthese for shoulder joint is internally provided with sealing element, while the proximal end setting of the prosthese for shoulder joint
There is interconnecting piece, the interconnecting piece has the hollow channel being connected to prosthese inside;Wherein:
The distal end of the delivery conduit is for detachably connected with the interconnecting piece, to push the vacation for being used for shoulder joint
Body;The drive rod is movably inserted into the delivery conduit and passes through the interconnecting piece and connect with the sealing element, the drive
Lever is for driving the sealing element to be at least partially into the hollow channel, so that sealing element closure is described hollow logical
Road.
25. prosthetic appliance according to claim 24, which is characterized in that the drive rod is connected with the sealing element
Region is weakness zone, and the ultimate strength of the weakness zone is less than the ultimate strength of the sealing element and the drive rod, with
It is broken the drive rod at the weakness zone under external force, and makes the drive rod and the sealing element phase point
From.
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CN201910147605.6A CN109758269A (en) | 2019-02-27 | 2019-02-27 | Prosthese and prosthetic appliance for shoulder joint |
PCT/CN2020/076240 WO2020173401A1 (en) | 2019-02-27 | 2020-02-21 | Prosthesis for shoulder joint and prosthesis device |
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CN201910147605.6A CN109758269A (en) | 2019-02-27 | 2019-02-27 | Prosthese and prosthetic appliance for shoulder joint |
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Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110974489A (en) * | 2019-10-11 | 2020-04-10 | 杭州锐健马斯汀医疗器材有限公司 | Special-shaped balloon capable of relieving injury of human tissues and other tissues and preparation method thereof |
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CN111759532A (en) * | 2020-07-07 | 2020-10-13 | 复旦大学附属华山医院 | Do not rely on sacculus under shoulder peak of cyst wall leakproofness for long-term use |
WO2023029734A1 (en) * | 2021-09-01 | 2023-03-09 | 上海竞捷医疗科技有限公司 | Repair device for joint tissue |
WO2023029761A1 (en) * | 2021-09-01 | 2023-03-09 | 上海竞捷医疗科技有限公司 | Prosthesis protection device and rotator cuff prosthesis system |
WO2023029735A1 (en) * | 2021-09-01 | 2023-03-09 | 上海竞捷医疗科技有限公司 | Repair apparatus for shoulder joint, and prosthetic system |
WO2023029732A1 (en) * | 2021-09-01 | 2023-03-09 | 上海竞捷医疗科技有限公司 | Conveying apparatus and prosthesis system |
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