CN107928837B

CN107928837B - Partially absorbable patch for rotator cuff repair and method of manufacture

Info

Publication number: CN107928837B
Application number: CN201710994442.6A
Authority: CN
Inventors: 陈晓; 季杰; 赖卫国
Original assignee: Shanghai Ligetai Biotechnology Co ltd
Current assignee: Shanghai Ligetai Biotechnology Co ltd
Priority date: 2017-10-23
Filing date: 2017-10-23
Publication date: 2023-06-13
Anticipated expiration: 2037-10-23
Also published as: CN107928837A

Abstract

The invention provides a part of absorbable patch for rotator cuff repair, which comprises a braiding body and a coating; the braid comprises a support base layer comprising one or more braid elements; the coating is arranged on one or all of the two end surfaces of the support base layer along the thickness extending direction; the support base layer is made of non-degradable materials, and the coating is made of degradable materials; the coating is sprayed on the support base layer. Correspondingly, the invention also provides a manufacturing method of the partially absorbable patch for rotator cuff repair. The invention has higher initial fixing strength, can simultaneously ensure that the rotator cuff and the humerus head are tightly combined, and reduces the gap; and along with the gradual degradation of collagen, the connective tissue of the human body gradually grows into micropores of the patch to form an integral structure, so that the healing of the rotator cuff is quickened.

Description

Partially absorbable patch for rotator cuff repair and method of manufacture

Technical Field

The invention relates to the field of medical instruments, in particular to a partially absorbable patch for rotator cuff repair and a manufacturing method thereof.

Background

The rotator cuff injury is common injury of the rotator joints, the patient often has shoulder pain after a certain trauma, the movement is limited, and the main symptoms of the rotator cuff injury are as follows: pain on the outside of the shoulder, and can radiate to the neck, upper arm; pain is aggravated when the shoulder abducts or performs whiplash movements in which the shoulder rotates from the outside to the inside rapidly; when the shoulder is outward-rotating, outward-expanding and anti-blocking, obvious pain also occurs to the shoulder; when the rotator cuff injury time is long, deltoid atrophy is also caused. In normal population, rotator cuff injury accounts for 5% -40% of shoulder joint diseases, and in population over 60 years old accounts for 17% -41%.

The current clinical rotator cuff injury repair technology comprises a single-row and double-row anchor with wires and an osteosynthesis technology. With the improvement of repair instruments and the improvement of repair technologies, a great deal of rotator cuff injuries can be sutured with tendons and bones, but partial rotator cuffs can not be repaired due to huge tearing and tissue contracture, so that some technologies for repairing rotator cuffs by tendon transfer technology are clinically presented, wherein the most common technologies are pectoral large muscle transfer technology and latissimus dorsi transfer technology. However, when the patient's shoulder joint has an unstable anterior superior or a large rotator cuff injury, the effect is not ideal in terms of pain or function. Although the rotator cuff repair technique has been significantly advanced, there is still a 38% -94% post-operative re-tear rate, particularly with a low degree of tendon-bone healing of degenerative rotator cuff injuries.

Ideal rotator cuff repair: the initial fixing strength is higher, and the initial strength of the rotator cuff is achieved; the gap between the rotator cuff and the humeral head is as small as possible; the mechanical stability can be maintained after repeated activities; the mechanical stability can be kept when cyclic load is loaded; the biological environment of the "healing site" is optimized.

Disclosure of Invention

In view of the shortcomings of the prior art, it is an object of the present invention to provide a partially absorbable patch for rotator cuff repair and method of manufacture.

The invention provides a part of absorbable patch for rotator cuff repair, which comprises a braiding body and a coating; the braid comprises a support base layer comprising one or more braid elements;

the coating is arranged on one or all of the two end surfaces of the support base layer along the thickness extending direction;

the support base layer is made of non-degradable materials, and the coating is made of degradable materials; the coating is sprayed on the support base layer.

Preferably, a plurality of knitting units of the same layer in the thickness extending direction in the knitting body are sequentially connected to form a knitting layer;

the woven fabric comprises a plurality of woven layers, wherein the woven layers are sequentially stacked in the thickness extension direction of the woven body;

the two adjacent braiding layers can slide relatively and enable the braiding bodies to be switched between an initial state and an unfolding state:

in the initial state, a plurality of braiding layers are stacked in a flush way, a plurality of braiding units are arranged in a matrix on the cross section of a braiding body, and the width of the braiding body is minimum;

in the unfolded state, the plurality of braiding layers are staggered and stacked, and on the cross section of the braiding body, the plurality of braiding units are arranged in a parallelogram shape, so that the width of the braiding body is enlarged.

Preferably, the braid further comprises an elastic cord;

the elastic rope is connected with two adjacent braiding units of the braiding body in the thickness extending direction in the initial state;

in the unfolded state, the elastic cord is in a stretched state.

Preferably, two ends of the braiding body along the width extension direction are respectively provided with a first traction piece and a second traction piece;

in the thickness extending direction of the braiding parts, the first traction part and the second traction part are respectively connected to the two outermost braiding layers.

Preferably, the traction piece is integrally formed with or fixedly connected with the braiding part;

the traction piece comprises traction ropes, one or more traction ropes are arranged on any one of two sides in the width direction of the braiding, and the traction ropes on the same side are connected to the same braiding layer; the other ends of the two ends of the traction ropes in the axial direction, which are opposite to the end connected with the braiding bodies, form free ends, and the free ends of the traction ropes are mutually separated, partially connected or fully connected; or alternatively, the process may be performed,

the traction piece is a braiding unit protruding out along the width extension direction of the braiding body.

Preferably, the cross-sectional shape of the knitting unit is arc-shaped; in the initial state, the cross section of the braiding part is in a folded shape.

Preferably, the adhesive further comprises an elastic coating; the whole or part of the braiding body is covered by the elastic covering film;

the elastic coating film generates elastic deformation along with the transition of the braiding body between an initial state and an unfolding state.

Preferably, the plurality of woven elements in a single woven layer are integrally formed, sequentially bonded or sequentially stitched.

Preferably, the coating material is collagen;

the supporting base layer is made of polymer porous fabric and is made of any one or more of the following materials:

-polyester;

-polypropylene;

-polyvinylidene fluoride monofilament or multifilament;

expanded polytetrafluoroethylene yarn.

The invention also provides a manufacturing method of the partially absorbable patch for rotator cuff repair, which comprises the following steps:

step A: obtaining a polymer porous fabric by warp knitting yarns made of non-degradable material;

and (B) step (B): cutting the polymer porous fabric by laser, ultrasonic waves or a hot knife to obtain a support base layer;

step C: and spraying collagen fibers on the support base layer through electrostatic spinning or ultrasonic spraying to form a coating.

Compared with the prior art, the invention has the following beneficial effects:

1. the invention has higher initial fixing strength, can simultaneously ensure that the rotator cuff and the humerus head are tightly combined, and reduces the gap; and along with the gradual degradation of collagen, the connective tissue of the human body gradually grows into micropores of the patch to form an integral structure, so that the healing of the rotator cuff is quickened.

2. The support base layer has excellent mechanical strength and good flexibility, and can well assist tissue remodeling.

3. The coating is natural active protein, has low immunogenicity, good biocompatibility and histocompatibility, and is nontoxic to cells and organisms, and does not or less cause inflammation and immune rejection reaction.

4. The braiding bodies adopted by the invention have smaller diameter of the circumcircle in the initial state, and are convenient to pass through the incision; through stretching, the expansion can be performed step by step, and the requirements of different expansion areas are met.

5. The invention can solve the problem of higher re-tearing rate in the prior operation and the problem that the operation cannot be effectively repaired due to huge tearing, and has great clinical significance.

Drawings

Other features, objects and advantages of the present invention will become more apparent upon reading of the detailed description of non-limiting embodiments, given with reference to the accompanying drawings in which:

FIG. 1 is a schematic diagram of a braid structure;

FIG. 2 is a schematic diagram of a weave unit material construction;

FIG. 3 is a schematic view of the structure of the initial state of the braid;

FIG. 4 is a schematic view of a preliminary developed structure of a woven body subjected to stretching;

FIG. 5 is a schematic view of a further developed structure of the braid under tension;

fig. 6 is a schematic diagram of a woven structure coated with an elastic coating.

The figure shows:

Detailed Description

The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the present invention, but are not intended to limit the invention in any way. It should be noted that variations and modifications could be made by those skilled in the art without departing from the inventive concept. These are all within the scope of the present invention.

In the description of the present invention, it should be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.

As shown in fig. 1 and 2, in an embodiment, the partially absorbable patch for rotator cuff repair provided by the present invention comprises a woven body 1 and a coating 3; the woven body 1 comprises a support base layer 2, the support base layer 2 comprises one or more woven units 100, and the coating 3 is arranged on two end surfaces of the support base layer 2 along the thickness extending direction. The supporting base layer 2 is a non-degradable polymer porous fabric, plays a role in mechanical supporting, provides mechanical strength, and is made of any one or more of the following materials: polyester, polypropylene, polyvinylidene fluoride monofilament or multifilament, expanded polytetrafluoroethylene yarns. The porous polymer fabric is woven by warp knitting, and then cut into a specific shape by laser, ultrasonic or a hot knife; the support base layer 2 has excellent mechanical strength and good flexibility, and can well assist tissue remodeling. The upper and lower coating layers 3 are made of collagen, which is a natural active protein, has low immunogenicity, good biocompatibility and histocompatibility, and is nontoxic to cells and organisms, and does not or less cause inflammation and immune rejection. The collagen fiber is sprayed on the support base layer 2 through electrostatic spinning or ultrasonic spraying to form the coating 3, so that the woven body 1 has excellent tissue compatibility and accelerates tissue growth. In the preferred embodiment, the braid 1 comprises only one braiding unit 100, that is, the braid 1 is integrally formed, and the surface area is adjusted by folding and unfolding during use to meet the use requirements under different conditions, but the structure is inconvenient to operate when passing through a small incision. Preferably, the coating 3 may be located only on one of the two end surfaces of the support base layer 2 along the thickness extending direction, so as to reduce the processing difficulty of the woven body 1, but correspondingly reduce the therapeutic effect.

In the embodiment, as shown in fig. 3 to 5, the braid 1 includes a plurality of braid units 100, and the plurality of braid units 100 of the same layer in the thickness extension direction in the braid 1 are sequentially connected to form the braid 10, and the plurality of braid units 100 in the braid 10 are integrally formed, sequentially bonded, or sequentially sewn. The two braiding layers 10 are stacked in turn in the thickness extension direction of the braiding body 1, and two adjacent braiding layers 10 can slide relatively and enable the braiding body 1 to be switched between an initial state and an unfolding state: as shown in fig. 3, in the initial state, the plurality of braid 10 are stacked in a flush manner, and the plurality of braid units 100 are arranged in a matrix shape in the cross section of the braid 1, so that the width of the braid 1 is minimum; as shown in fig. 4 and 5, in the developed state, the plurality of braid 10 are stacked in a staggered manner, and the plurality of braid elements 100 are arranged in a parallelogram shape in the cross section of the braid 1, so that the width of the braid 1 is increased. The braid 1 further comprises an elastic rope 4, wherein the elastic rope 4 is connected with two adjacent braiding units 100 of the braid 1 in the initial state along the thickness extending direction, and the two adjacent braiding layers 10 are pulled and bonded; when the braiding layers 10 are staggered from each other, the elasticity is also stretched, so that the braiding body 1 maintains the stability of the whole structure under the action of the partial force in the thickness extending direction. The two ends of the braiding part 1 along the width extension direction are respectively provided with a first traction piece 51 and a second traction piece 52, the first traction piece 51 and the second traction piece 52 are respectively connected to the two outermost braiding layers 10 along the thickness extension direction of the braiding part 1, the traction pieces can be traction ropes or braiding units 100 protruding in the width direction, one or more traction ropes are arranged on any one of two sides along the width direction of the braiding part 1, and the traction ropes on the same side are connected to the same braiding layer 10; the other end of the traction rope opposite to the end connected with the braiding 1 forms a free end in the axial direction, the free ends of the traction ropes are mutually separated, partially connected or fully connected, and the traction piece is arranged to help a doctor adjust the surface area of the braiding 1 in the use process. In addition, as shown in fig. 6, the periphery of the braiding unit 1 is further covered with an elastic covering film 6, the elastic covering film 6 covers the upper end face and the lower end face of the braiding unit 1, and two ends of the elastic covering film 6 are respectively and tightly connected with two ends of the braiding unit 1 along the width direction, preferably, the elastic covering film 6 covers the braiding unit 1 along the circumferential direction and is respectively and tightly connected with the braiding unit 100 at the leftmost upper corner and the braiding unit 100 at the rightmost lower corner, so that when the area of the braiding unit 1 changes, the elastic covering film 6 is also pulled and unfolded, thereby being beneficial to clamping the braiding unit 1 from the upper direction and the lower direction. Preferably, the cross-sectional shape of the knitting unit 100 is arc, in the initial state, the cross-sectional shape of the knitting body 1 is in a folded tile shape, the concave part of the arc-shaped knitting unit 100 forms a containing groove, and the knitting unit 100 of the previous layer is just contained, so that the function of fixing in the width extending direction can be achieved, and the stability of the knitting body 1 in the unfolded state is increased; further, the curved structure of the knitting unit 100 allows both ends to deform toward the middle when receiving a component force in the width direction, and thus the overall structure of the knitting unit 100 is more compact.

Working principle: before implantation, the braiding 1 is in a folded shape, as shown in fig. 3, and the largest circumcircle diameter of the braiding 1 is smaller due to the folded shape, so that the braiding can easily pass through a small incision. After the braid 1 passes through the small incision, the braid 10 can be spread step by pulling the pulling member as shown in fig. 4. As shown in fig. 5, pulling on the traction member can further expand the braid 10, meeting the needs of different areas of expansion of the practitioner. The two adjacent braiding layers 10 are kept in fit under the action of the elastic rope 4, the elastic coating film 6 on the periphery of the braiding body 1 is elastically deformed along with the expansion of the braiding body 1, the braiding body 1 is clamped in the up-down direction under the action of resilience force, and the smoothness of the upper surface and the lower surface of the braiding body 1 is ensured.

The invention also provides a manufacturing method of the partially absorbable patch for rotator cuff repair, which comprises the following steps: step A: obtaining a polymer porous fabric by warp knitting yarns made of non-degradable material; and (B) step (B): cutting the polymer porous fabric by laser, ultrasonic waves or a hot knife to obtain a support base layer 2; step C: the coating 3 is formed by spraying collagen fibers onto the support base layer 2 by electrospinning or ultrasonic spraying.

The foregoing describes specific embodiments of the present invention. It is to be understood that the invention is not limited to the particular embodiments described above, and that various changes and modifications may be made by one skilled in the art within the scope of the claims without affecting the spirit of the invention. The embodiments of the present application and features in the embodiments may be combined with each other arbitrarily without conflict.

Claims

1. A partially absorbable patch for rotator cuff repair comprising a woven fabric and a coating; the braid comprises a support base layer comprising one or more braid elements;

the support base layer is made of non-degradable materials, and the coating is made of degradable materials; the coating is sprayed on the supporting base layer;

a plurality of braiding units of the same layer in the braiding body along the thickness extending direction are sequentially connected to form a braiding layer;

2. A partially absorbable patch for rotator cuff repair according to claim 1, wherein said knit further comprises an elastic strand;

in the unfolded state, the elastic cord is in a stretched state.

3. A partially absorbable patch for rotator cuff repair according to claim 2, wherein the woven body is provided with two traction members, a first traction member and a second traction member, at both ends in the width extension direction, respectively;

4. A partially absorbable patch for rotator cuff repair according to claim 3, wherein said traction member is integrally formed with or fixedly attached to the woven body;

5. A partially absorbable patch for rotator cuff repair according to claim 2, wherein said knit unit is arcuate in cross-sectional shape; in the initial state, the cross section of the braiding part is in a folded shape.

6. A partially absorbable patch for rotator cuff repair according to claim 1, further comprising an elastic cover; the whole or part of the braiding body is covered by the elastic covering film;

7. A partially absorbable patch for rotator cuff repair according to claim 1, wherein multiple woven elements in a single woven layer are integrally formed, sequentially bonded or sequentially stitched.

8. A partially absorbable patch for rotator cuff repair according to claim 1, wherein said coating material is collagen;

-polyester;

-polypropylene;

-polyvinylidene fluoride monofilament or multifilament;

expanded polytetrafluoroethylene yarn.

9. A method of manufacturing a partially absorbable patch for rotator cuff repair comprising the steps of:

step C: spraying collagen fibers on the support base layer through electrostatic spinning or ultrasonic spraying to form a coating;

the support base layer comprises one or more woven elements;