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Cruciate ligament regenerative implant and its preparation method and application

A cruciate ligament, regenerative technology, applied in ligaments, medical science, prosthesis, etc., can solve problems such as long operation time, limited supply of grafts, and limited sources

Active Publication Date: 2020-08-11
SHANGHAI P & P BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Disadvantages: 1) Remove the east wall to make up the west wall, and the graft supply site will cause permanent dysfunction; 2) The operation time is long and the damage caused to the patient is large; 3) It is difficult for the patient to accept; 4) When multiple ligaments are damaged, Graft supply is limited
[0011] Disadvantages: 1) the spread of infectious diseases; 2) the country currently has no officially approved products for marketing; 3) low mechanical strength; 4) limited sources
[0014] Disadvantages: 1) No ligament tissue regeneration; 2) No tendon-bone healing formation; 3) The joint stability is poor as the implantation time prolongs; 4) The incidence of joint aseptic inflammation (such as synovitis, etc.) is high; 5) At present, only the French LARS ligament is used clinically, and the promotion rate is not high
Unfortunately, prior art 1 and prior art 2 have no corresponding animal experiment examples to illustrate it

Method used

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  • Cruciate ligament regenerative implant and its preparation method and application
  • Cruciate ligament regenerative implant and its preparation method and application
  • Cruciate ligament regenerative implant and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Example 1: Combination of mechanical support structures and determination of maximum tensile force

[0064] Construct mechanical support structures 1-4 as follows:

[0065] Take 90 sutures of 500mm long USP7-0PDSII (diameter: 0.07mm) and weave them to form a diameter of 0.66mm and a cross-sectional area of ​​0.35mm 2 The mechanical support structure 1;

[0066] Take 80mm long USP7-0 PDSII (diameter: 0.07mm) sutures 10, after weaving, the diameter is 0.22mm, and the cross-sectional area is 0.04mm 2 Mechanical support structure 2;

[0067] Take 1 USP2-0PDSII suture with a length of 100mm, and form a diameter (mean value) of 0.34mm and a cross-sectional area of ​​0.09mm 2 Mechanical support structure 3;

[0068] Take a 350mm long USP2-0PDSII (diameter: 0.34) to form a diameter of 0.34mm and a cross-sectional area of ​​0.09mm 2 Mechanical support structure4.

[0069]Fix 6 pieces of each of the above mechanical support structures 1-4 on a mechanical analyzer (Instron 5...

Embodiment 2

[0073] Example 2 Combination of Regeneron and Measurement Results of Tensile Strength

[0074] Construct Regeneron 1-4 as follows:

[0075] Regeneron-1: Take 90 sutures of 50mm long USP7-0PDSII (diameter: 0.07mm), after weaving, the diameter is 0.66mm, and the cross-sectional area is 0.35mm 2 The mechanical support structure; take the electrospun support material (length: 100mm) with a thickness of 0.2-0.25mm to wrap the mechanical support structure layer by layer, so that the final diameter is 1.00mm, of which: the cross-sectional area of ​​the regenerated element is 0.79mm 2 , the regenerative cross-sectional area is 0.44mm 2 , the regeneration ratio is: 56%;

[0076] Regeneron-2: Take 10 80mm long USP7-0PDSII (diameter: 0.07mm) sutures to form a diameter of 0.22mm and a cross-sectional area of ​​0.04mm 2 The mechanical support structure; take the electrospun support material (length: 100mm) with a thickness of 0.2-0.25mm to wrap the mechanical support structure layer by ...

Embodiment 3

[0088] Example 3 Combination of Regeneron Sets and Measurement of Mechanical Strength

[0089] Regeneron sets 1-4 (i.e. cruciate ligament regenerative implants) were constructed as follows:

[0090] Regeneron set-1: Take a total of 20 regeneron-1 prepared in Example 2, and combine them into bundles to form a diameter of 4mm, and the cross-sectional area of ​​the regeneron set is 16mm 2 The regenerator set-1;

[0091] Regeneron Set-2: Take a total of 25 Regeneron-2 prepared in Example 2, and combine them into bundles to form a diameter of 10mm, and the cross-sectional area of ​​the Regeneron Set is 79mm 2 Regeneron set-2;

[0092] Regeneron set-3: Take 20 pieces of Regeneron-3 prepared in Example 2, combine them into bundles, form a diameter of 9mm, and the cross-sectional area of ​​the regeneron set is 60mm 2 Regeneron set-3;

[0093] Regeneron set-4: Take a total of 62 regeneron-4 prepared in Example 2, combine them into bundles, form a diameter of 5mm, and regeneron set ...

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Abstract

Disclosed are a cruciate ligament regenerative implant and a preparation method therefor and the application thereof. A surgical suture-like structure made of a degradable polymer material is used as a starting mechanical support structure; a membrane-like structure made of a composite electrospun scaffold material is used as a tissue remoulding and regenerating core structure closely wound around the starting mechanical support structure, thereby constituting a ligament regeneration element; and several of these ligament regeneration elements constitute a ligament regeneration element set so as to obtain a ligament regenerative implant. Results of an experiment on goats prove that after the implant is implanted into the body, the implant is fully degraded within 52 weeks, induces the formation of an autologous ligament tissue in the knee joint cavity, and induces tendon-bone healing at the tunnel interface of the tibia and the femur; and within 2 months after implantation, the maximum tension of the regenerative ligament is at 20-60% of a normal ligament tissue.

Description

technical field [0001] The invention relates to a regenerative implant for treating rupture of the cruciate ligament of the knee joint, a preparation method and application thereof. Background technique [0002] 1 Cruciate ligament injuries and treatment options [0003] 1.1 Cruciate ligament injury [0004] The cruciate ligament is located in the knee joint and connects the femur to the tibia, maintaining the stability of the knee joint. The incidence of cruciate ligament rupture: the general population in the United States is about 1 / 3000, while football players are 60 / 100,000; active athletes in my country are 0.43%. [0005] 1.2 Clinical treatment of cruciate ligament injury: The best treatment option is surgical reconstruction. Graft materials that can be used include: autologous tissue (such as hamstring tendon, autologous patellar tendon, etc.), allogeneic tissue and synthetic material grafts. The pros and cons of the various grafts are as follows: [0006] 1.2.1...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/08
CPCA61F2/0811A61F2002/0817A61F2002/0847A61F2002/0882A61F2210/0004A61F2240/001
Inventor 何红兵苏岭杨莉
Owner SHANGHAI P & P BIOTECH
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