Method for manufacturing bioinductive patch

This application claims the benefit of U.S. Provisional Application No. 62/586,651, filed Nov. 15, 2017, the entire disclosure of which is incorporated by reference herein.

The disclosure relates to a method for manufacturing a patch, more particular to a method for manufacturing a bioinductive patch.

Rotator cuff tear is one of the most common tendon disorders, which is often caused by chronic wear and tear with degeneration of the tendon. Rotator cuff tear can also occur in people who repeatedly perform overhead motions in their jobs or sports. According to statistics, approximately 13% of the population at an age greater than 50 suffers from rotator cuff tear, and over half of the population at an age greater than 80 is diagnosed with a rotator cuff tendon injury.

Treatment of the rotator cuff tear often includes surgical repair, but the rate of failure to gain or maintain healing has been reported to be as high as over 90%. This has been substantially attributed to the inadequate capacity of rotator cuff to heal once damaged. Scaffolds have been developed to improve rotator cuff-bone healing and rotator cuff regeneration, but not possess durable biological characteristics and ideal healing rate.

In accordance with one aspect of the present disclosure, a bioinductive patch includes a patch body and a button. The patch body has an inner space. The button is disposed in the inner space of the patch body.

In accordance with another aspect of the present disclosure, a method for manufacturing a bioinductive patch includes step in which a patch body having an inner space is provided. The method continues with step in which a button is disposed in the inner space of the patch body.

Aspects of the present disclosure are understood from the following detailed description when read with the accompanying figures. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion.

FIG. 1 is a perspective view of a bioinductive patch in accordance with some embodiments of the present disclosure.

FIG. 2 is a cross-sectional view of a bioinductive patch in accordance with some embodiments of the present disclosure.

FIG. 3 illustrates a cross-sectional view of a bioinductive patch for reattaching a biological tissue to a hard tissue in accordance with some embodiments of the present disclosure.

FIG. 4 is a perspective view of a button in accordance with some embodiments of the present disclosure.

FIG. 5 is a cross-sectional view of a button in accordance with some embodiments of the present disclosure.

FIG. 6 is a top view of a button in accordance with some embodiments of the present disclosure.

FIG. 7 is a bottom view of a button in accordance with some embodiments of the present disclosure.

FIG. 8 illustrates a cross-sectional view of a bioinductive patch with a force sensor for reattaching a biological tissue to a hard tissue in accordance with some embodiments of the present disclosure.

FIG. 9 is a flow diagram illustrating a method for manufacturing a bioinductive patch in accordance with some embodiments of the present disclosure.

FIG. 10A illustrates a schematic view of a patch body corresponding to the step 901 of FIG. 9 .

FIG. 10B illustrates a schematic view of a button disposed in the patch body corresponding to the step 902 of FIG. 9 .

It is to be understood that the following disclosure provides many different embodiments or examples, for implementing different features of various embodiments. Specific examples of components and arrangements are described below to simplify the present disclosure. The present disclosure may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein; rather, these embodiments are provided so that this description will be thorough and complete, and will fully convey the present disclosure to those of ordinary skill in the art. It will be apparent, however, that one or more embodiments may be practiced without these specific details.

In addition, the present disclosure may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed.

It will be understood that when an element is referred to as being “on” another element, it can be directly on the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly on” another element, there are no intervening elements present.

It will be understood that singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms; such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

Referring to FIGS. 1-3 , a bioinductive patch 10 is designed to be placed on a biological tissue 20 . In some embodiments, the biological tissue 20 is a soft tissue such as rotator cuff. In some embodiments, the biological tissue 20 can also be a hard tissue such as the bone chip. In some embodiments, the bioinductive patch 10 is used to help detatched biological tissue 20 (as rotator cuff) heal onto a hard tissue 30 (as humerus).

The bioinductive patch 10 includes a patch body 11 and a button 12 . The patch body 11 is made of bioabsorbable material. In some embodiments, the bioabsorbable material is decellularized collagen or amniotic membrane which can provide an environment that promotes the biological tissue 20 healing and regeneration.

The patch body 11 has an inner space 11 S and an opening 11 P. The inner space 11 S is in communication with the opening 11 P. In the present embodiment, the patch body 11 is in envelope shape.

The button 12 is disposed in the inner space 11 S of the patch body 11 through the opening 11 P.

Referring to FIGS. 2, 4 and 5 , the button 12 has a top surface 12 A, a bottom surface 12 B, a central portion 121 , two side curved portions 122 , and two suture holes 123 .

The top surface 12 A contacts the patch body 11 . In the present embodiment, the top surface 12 A is an arc surface to match the geometry of the hard tissue.

Referring to FIGS. 3 and 6 , in order to enhance the elasticity of the button 12 , the button 12 can have a plurality of top cavities 124 formed on the top surface 12 A. In some embodiments, the top cavities 124 can be disposed with at least one growth factor 124 G. The growth factor 124 G can be bonded and retained to the patch body 11 .

Referring to FIGS. 2, 4 and 5 again, the bottom surface 12 B contacts the patch body 11 . In the present embodiment, the bottom surface 12 B includes a level plane LP and two inclined planes IP. The level plane LP is located at the central portion 121 . The two inclined planes IP are located at two sides of the level plane LP, respectively.

Referring to FIGS. 3 and 7 , in order to enhance the elasticity of the button 12 , the button 12 can have a plurality of bottom cavities 125 formed on the bottom surface 12 B. In some embodiments, the bottom cavities 125 can be disposed with at least one growth factor 125 G. The growth factor 125 G can bond to the patch body 11 and be retained inside the cavities.

Referring to FIG. 5 again, the central portion 121 has a center maximum thickness MT to increase overall stiffness and avoid breakage.

The two side curved portions 122 are connected to two sides of the central portion 121 , respectively. In the present embodiment, the center maximum thickness MT of the central portion 121 is greater than or equal to a thickness T of the side curved portion 122 to ensure that the button 12 can have a sufficient bending strength.

Referring to FIGS. 2, 3 and 5 again, the two suture holes 123 are formed at the two side curved portions 122 , respectively. At least one suture 14 can penetrate the two suture holes 123 to press the button 12 and the patch body 11 on the biological tissue 20 . In the present embodiment, the at least one suture 14 is secured to suture anchors 15 or the tunnel inside the hard tissue 30 , and the suture anchors 15 are configured to fix on the hard tissue 30 .

Referring to FIGS. 3 and 8 , a force sensor 13 can be disposed on the button 12 to detect a force variation between the button 12 and the biological tissue 20 . The force sensor 13 can be pressure sensor, shear force sensor or tensile force sensor. Accordingly, the force variation can be pressure variation, shear force variation or tensile force variation.

In the present embodiment, the button 12 has a bottom recession 126 dented from the bottom surface 12 B and located at the central portion 121 . The force sensor 13 is disposed in the bottom recession 126 . Preferably, the force sensor 13 does not protrude from the bottom recession 126 . In some embodiments, the bottom recession 126 can be filled with a sealing material 127 to seal the force sensor 13 .

To improve the accuracy of the detected force variation, the force sensor 13 is located between the two suture holes 123 .

According to above configurations, the bioinductive patch 10 of the present invention can effectively improve biological tissue-hard tissue healing and possess durable biological characteristics.

Referring to FIG. 9 , a method 900 includes step 901 in which a patch body is provided, wherein the patch body has an inner space.

In FIG. 10A , a patch body 11 is provided. The patch body 11 is made of decellularized material. In some embodiments, the material is decellularized bioinductive collagen or amniotic membrane which can provide an environment that promotes the biological tissue healing and regeneration.

The patch body 11 has an inner space 11 S and an opening 11 P. The inner space 11 S is in communication with the opening 11 P. In the present embodiment, the patch body 11 is in envelope shape.

Referring to FIG. 9 again, the method 900 continues with step 902 in which a button is disposed in the inner space of the patch body.

In FIG. 10B , a button 12 is disposed in the inner space 11 S of the patch body 11 through the opening 11 P, to form the bioinductive patch 10 .

Referring to FIGS. 2, 4 and 5 again, the button 12 has a top surface 12 A, a bottom surface 12 B, a central portion 121 , two side curved portions 122 , and two suture holes 123 .

The top surface 12 A contacts the patch body 11 . In the present embodiment, the top surface 12 A is an arc surface to match the geometry of the hard tissue.

Referring to FIGS. 3 and 6 again, in order to enhance the elasticity of the button 12 , the button 12 can have a plurality of top cavities 124 formed on the top surface 12 A. In some embodiments, the top cavities 124 can be disposed with at least one growth factor 124 G. The growth factor 124 G can be bonded and retained to the patch body 11 .

Referring to FIGS. 2, 4 and 5 again, the bottom surface 12 B contacts the patch body 11 . In the present embodiment, the bottom surface 12 B includes a level plane LP and two inclined planes IP. The level plane LP is located at the central portion 121 . The two inclined planes IP are located at two sides of the level plane LP, respectively.

Referring to FIGS. 3 and 7 again, in order to enhance the elasticity of the button 12 , the button 12 can have a plurality of bottom cavities 125 formed on the bottom surface 12 B. In some embodiments, the bottom cavities 125 can be disposed with at least one growth factor 125 G. The growth factor 125 G can bond to the patch body 11 and be retained inside the cavities.

Referring to FIG. 5 again, the central portion 121 has a center maximum thickness MT to increase overall stiffness and avoid breakage.

The two side curved portions 122 are connected to two sides of the central portion 121 , respectively. In the present embodiment, the center maximum thickness MT of the central portion 121 is greater than or equal to a thickness T of the side curved portion 122 to ensure that the button 12 can have a sufficient bending strength.

Referring to FIGS. 2, 3 and 5 again, the two suture holes 123 are formed at the two side curved portions 122 , respectively. At least one suture 14 can penetrate the two suture holes 123 to press the button 12 and the patch body 11 on the biological tissue 20 . In the present embodiment, the at least one suture 14 is secured to suture anchors 15 or the tunnel inside the hard tissue 30 , and the suture anchors 15 are configured to fix on the hard tissue 30 .

Referring to FIGS. 3 and 8 again, a force sensor 13 can be disposed on the button 12 to detect a force variation between the button 12 and the biological tissue 20 . The force sensor 13 can be pressure sensor, shear force sensor or tensile force sensor. Accordingly, the force variation can be pressure variation, shear force variation or tensile force variation.

In the present embodiment, the button 12 has a bottom recession 126 dented from the bottom surface 12 B and located at the central portion 121 . The force sensor 13 is disposed in the bottom recession 126 . Preferably, the force sensor 13 does not protrude from the bottom recession 126 . In some embodiments, the bottom recession 126 can be filled with a sealing material 127 to seal the force sensor 13 .

To improve the accuracy of the detected force variation, the force sensor 13 is located between the two suture holes 123 .

The above method of the present invention includes only two steps, which has the advantages of short manufacture period and low manufacturing cost.

Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, and composition of matter, means, methods and steps described in the specification. As those skilled in the art will readily appreciate form the present disclosure, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed, that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized in accordance with some embodiments of the present disclosure.

Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, and compositions of matter, means, methods or steps. In addition, each claim constitutes a separate embodiment, and the combination of various claims and embodiments are within the scope of the invention.