Patent Application
20190099520
The present disclosure relates to tissue treatment devices, more particularly to tissue matrices combined with elongated synthetic elements to provide structural reinforcement, and to methods for treatment of anatomic defects with tissue treatment devices and to methods for making tissue treatment devices.
Various tissue-derived products are used to regenerate, repair, or otherwise treat diseased or damaged tissues and organs. Such products can include tissue grafts and/or processed tissues (e.g., acellular tissue matrices from skin, intestine, or other tissues, with or without cell seeding). Such products generally have properties determined by the tissue source (i.e., tissue type and animal from which it originated) and the processing parameters used to produce the tissue products. Since tissue products are often used for surgical applications and/or tissue replacement or augmentation, the products should support tissue growth and regeneration and provide mechanical support to the defect in the implantation site.
In order to provide adequate support, tissue treatment devices must have sufficient strength to withstand the forces placed upon an implantation site. In addition, such devices must be properly secured to surrounding tissue and oriented to properly distribute applied forces to the devices without causing trauma to the implantation site.
Although effective for many indications, current tissue matrix products may develop laxity under prolonged loading. In addition, tissue matrices with different mechanical properties, e.g., higher strength (e.g., tensile, burst, tear) and/or reduced elongatability or higher elastic moduli may be desirable for some applications. Accordingly, the present disclosure provides improved tissue treatment products having synthetic elements within tissue matrices.
The present disclosure provides improved devices for treating anatomic defects. According to various embodiments, a device for treatment of an anatomic defect includes a flexible sheet of acellular tissue matrix having a first top surface and a second bottom surface. The device further includes one or more elongated synthetic elements, wherein when the flexible sheet of acellular tissue matrix lies flat, the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within the flexible sheet.
According to various embodiments, a device for treatment of an anatomic defect is provided. The device can be a flexible sheet of acellular tissue matrix having a first top surface and a second bottom surface. The device further includes one or more elongated synthetic elements extending through the flexible sheet such that the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within one or more portions of the flexible sheet. In addition, the one or more elongated synthetic elements are exposed on one or more portions of the first top surface of the device.
The present disclosure includes improved methods of producing a device for treatment of an anatomic defect. According to various embodiments, a method of producing a device for treatment of an anatomic defect includes selecting a flexible sheet of acellular tissue matrix having a first top surface and a second bottom surface. The method further includes inserting one or more elongated synthetic elements through at least a portion of an interior of the sheet of acellular tissue matrix such that when the flexible sheet of acellular tissue matrix lies flat, the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within the flexible sheet.
According to various embodiments, a method of producing a device for treatment of an anatomic defect includes selecting a flexible sheet of acellular tissue matrix having a first top surface and a second bottom surface. The method further includes inserting one or more elongated synthetic elements through at least a portion of an interior of the sheet of acellular tissue matrix such that the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within one or more portions of the flexible sheet, and are exposed on one or more portions of the first top surface of the flexible sheet.
The present disclosure includes also improved methods of treatment. According to various embodiments, the method includes selecting a treatment device and securing the treatment device within a selected anatomical site. The treatment device includes a flexible sheet of acellular tissue matrix having a first top surface and a second bottom surface and one or more synthetic elements, wherein when the flexible sheet of acellular tissue matrix lies flat, the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within the flexible sheet.
According to various embodiments, the method includes selecting a treatment device that includes a flexible sheet of acellular tissue matrix having a first top surface and a second bottom surface and one or more synthetic elements, such that the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within one or more portions of the flexible sheet and are exposed on one or more portions of the first top surface of the flexible sheet. The method further includes securing the flexible sheet of acellular tissue matrix and the one or more elongated synthetic elements within a selected anatomical site.
Reference will now be made in detail to certain exemplary embodiments according to the present disclosure, certain examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of “or” means “and/or” unless stated otherwise. Furthermore, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Any range described herein will be understood to include the endpoints and all values between the endpoints.
The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in this application, including but not limited to patents, patent applications, articles, books, and treatises, are hereby expressly incorporated by reference in their entirety for any purpose.
Various human and animal tissues can be used to produce products for treating patients. For example, various tissue products for regeneration, repair, augmentation, reinforcement, and/or treatment of human tissues that have been damaged or lost due to various diseases and/or structural damage (e.g., from trauma, surgery, atrophy, and/or long-term wear and degeneration) have been produced. Such products can include, for example, acellular tissue matrices, tissue allografts or xenografts, and/or reconstituted tissues (i.e., at least partially decellularized tissues that have been seeded with cells to produce viable materials).
A variety of tissue products have been produced for treating soft and hard tissues. For example, ALLODERM® and STRATTICE™ (LIFECELL CORPORATION, Branchburg, N.J.) are two dermal acellular tissue matrices made from human and porcine dermis, respectively. Although such materials are very useful for treating certain types of conditions, materials having different biological and mechanical properties may be desirable for certain applications. For example, ALLODERM® and STRATTICE™ have been used to assist in treatment of structural defects and/or to provide support to tissues (e.g., for abdominal walls or in breast reconstruction), and their strength and biological properties make them well-suited for such uses. Although effective for many applications, changes to such tissue matrices can make them even better for certain uses, including additional complex abdominal wall repairs, high load applications, or other complex anatomic defects.
Accordingly, disclosed herein are tissue matrix products that can include embedded synthetic elements. The synthetic elements can reinforce the tissue matrix to provide improved structural features useful for a variety of applications. The reinforced tissue matrix can be configured to distribute at least a portion of forces to synthetic elements within the reinforced tissue matrix, thereby improving treatment for some load-bearing applications. The synthetic elements are embedded within at least a portion of the tissue matrix material, thereby reducing or preventing direct contact with tissues to prevent undesirable immunologic responses that can lead to scarring, adhesion to the synthetic elements, or undesirable immunologic response.
The tissue matrix 110 is illustrated as a two-dimensional view of a flexible sheet of material. Accordingly, it should be appreciated that the flexible sheet will have a length and width, and a thickness. The length, width, and thickness can be selected based on the desired surgical indication, e.g., to provide a sufficient surface area (measured in terms of the length and width) and structural stability (e.g., based on strength, tensile properties, suture retention, burst strength, etc.). The flexible sheet 110 may range in width between 10 cm and 30 cm, between 10 cm and 25 cm, between 20 cm and 25 cm, or any ranges in between. In addition the flexible sheet 110 may range in length between 10 cm and 30 cm, between 15 cm and 30 cm, or between 20 cm and 25 cm, or any ranges in between. For dermal tissue matrix materials, the thickness can vary, but may be between, for example, 0.75 mm to 4 mm, 0.75 mm to 1.25 mm, or 1.05 mm to 1.55 mm.
The tissue matrix 110 may be composed of a variety of suitable materials. For example, in some embodiments, the tissue matrix 110 is produced from tissue derived from dermal, fascia, adipose, pericardial tissue, dura, umbilical cord tissue, placental tissue, cardiac valve tissue, ligament tissue, tendon tissue, arterial tissue, venous tissue, neural connective tissue, urinary bladder tissue, ureter tissue, dermal tissue, muscle, and intestinal tissue. The tissue may be selected from human or porcine tissue sources.
In some embodiments, the tissue matrix 110 is an acellular tissue matrix. In further embodiments, the tissue matrix 110 is dermal acellular tissue matrix. In further embodiments, the dermal acellular tissue may be selected from human or porcine tissue sources.
In addition, if extracellular matrix materials are used, the materials can be further processed to control desired properties, including porosity, mechanical properties (strength, compressibility, elasticity), and/or biological properties (e.g., enzyme susceptibility, in vivo degradation rate, and/or ability to support in growth and tissue regeneration for intended treatment sites). Such processing can include micronizing, re-suspension, cross-linking, defatting, decellularizing, and/or lyophilizing. Exemplary processing techniques are described further below.
As noted above, the device 100 further includes one or more elongated synthetic elements 120. The elongated synthetic elements 120 may be composed of any material capable of withstanding the various mechanical demands exerted upon the treatment device 100 in the implantation site. The various mechanical demands may include, but are not limited to, compressive strength, durability, elasticity, flexibility, impact resistance, shear modulus, shear strength, stiffness, tensile strength, and Young's modulus. For example, if the treatment device 100 is implanted over a midline incision of the abdomen, the elongated synthetic elements 120 can be capable of withstanding at least a primary force exerted upon the midline.
In some embodiments, the elongated synthetic elements 120 are non-resorbable. Treatment devices 100 including non-resorbable elongated synthetic elements 120 can be permanently left in an implantation site. Non-resorbable materials would be desirable in certain embodiments because resorbable materials lose strength over time as the body absorbs the material. In some embodiments, resorbable elongated synthetic elements 120 are desirable to create non-permanent treatment devices 100.
The elongated synthetic elements 120 may be composed of polymeric materials. In some embodiments, the elongated synthetic elements 120 comprise at least one of at least one of polypropylene, polytetrafluoroethylene, polyester, terephthalate, polyglycolide, or poly-4-hydroxybutyrate. In some embodiments, the elongated synthetic elements 120 may be composed of non-resorbable polymeric materials.
Each elongated synthetic element 120 has a flexible three-dimensional structure comprising a length dimension, a width dimension, and a height dimension. In some embodiments, the length is at least about one hundred times larger than the height and width. In some embodiments, the length is at least about five hundred times larger than the height and width. In some embodiments, the length is at least about one thousand times larger than the height and width. In some embodiments, the length is at least about two thousand times larger than the height and width.
In some embodiments, the elongated synthetic elements 120 pass through and protrude from at least one end of the tissue matrix 110. In some embodiments, the elongated synthetic elements 120 are surrounded by the tissue matrix material of the tissue matrix 110. The elongated synthetic elements 120 may be inserted through the tissue matrix 110 and cut or tied at each end of the tissue matrix 110. In some embodiments, the tissue matrix 110 is formed around the elongated synthetic elements 120. In further embodiments, the elongated synthetic elements 120 do not protrude out of the tissue matrix 110.
The elongated synthetic elements 120 may be oriented within the tissue matrix 110 according to an intended use of the treatment device 100 or according to the preference or a surgeon, physician, nurse, or other medical professional. The elongated synthetic elements 120 may be substantially parallel to the outer surfaces of the flexible sheet. In some embodiments, the elongated synthetic elements 120 may be at an angle relative to the first top surface 112 and the second bottom surface 114 of the tissue matrix 110. In some embodiments, the elongated synthetic elements 120 are substantially parallel with one another. In some embodiments, the elongated synthetic elements 120 may be evenly distributed throughout the flexible sheet. In some embodiments, a first group of elongated synthetic elements within the tissue matrix 110 extends perpendicularly to a second group of elongated synthetic elements within the tissue matrix 110, as depicted in
In some embodiments, the elongated synthetic elements 120 are sutures. The sutures may be monofilament, braided, braided and coated, or a combination thereof. In some embodiments, the sutures are non-resorbable.
The treatment device 100 further includes at least one fixation element 130 configured to attach the treatment device 100 to tissue. The fixation elements 130 may be barbs, flaps, tacks, tabs, hooks, adhesive-covered elements, or a combination thereof. In some embodiments, the fixation elements 130 are barbed sutures.
The fixation elements 130 may be composed of biocompatible materials. In some embodiments, the fixation elements 130 are composed of the same material as the elongated synthetic elements 120. In some embodiments, the fixation elements 130 are composed of synthetic materials. In some embodiments, the fixation elements 130 are non-resorbable. In some embodiments, the fixation elements 130 comprise at least one of polypropylene, polytetrafluoroethylene, polyester, terephthalate, polyglycolide, or poly-4-hydroxybutyrate.
The fixation elements 130 may be separate components of the treatment device 100 or may be extensions of the elongated synthetic elements 120. For example, the elongated synthetic elements 120 may extend outward from one or more surfaces of the tissue matrix 110 to form the fixation elements 130. As a further example, each fixation element 130 is a continuous extension of an elongated synthetic element 120. In other words, a treatment device 100 may include at least one unitary synthetic element of one elongated synthetic element 120 with a fixation element 130 on one or both ends of the elongated synthetic element 120. In this example, the elongated synthetic elements 120 and fixation elements 130 may be sutures.
In some embodiments, the fixation elements 130 are attached to the elongated synthetic elements 120. The fixation elements 130 may be attached to one or both exposed ends of each elongated synthetic element 120. In some embodiments, fixation elements 130 are attached to some, but not all of the elongated synthetic elements 120. The fixation elements 130 may be attached to the elongated synthetic elements 120 either before or after the elongated synthetic elements 120 are inserted through the tissue matrix 110, or the tissue matrix 110 is formed around the elongated synthetic elements 120. In some embodiments, during insertion, the fixation elements 130 pierce through the tissue matrix 110 to allow for insertion of the elongated synthetic elements 120.
The treatment device 100 may be produced in various shapes and sizes. For example, the treatment device 100 may be shaped to conform to an implantation site, fill an implantation site, surround an implantation site, or cover an implantation site. Although described as a sheet, the tissue matrix 110 could be in the form of a cylinder, box, sphere, or irregular shape.
A treatment device 100 shaped as a sheet may be used to surround or cover an implantation site. For example, the sheet may be wrapped around a tendon or ligament. The sheet may also cover an incision produced by surgery or other trauma. The sheet may cover any anatomical defect. In some embodiments, the sheet is oriented to withstand loads that will be forced upon the implantation site.
A treatment device 100 shaped as a cylinder may be used to surround or fill an implantation site. For example, the cylinder may be placed around a reconstructed implantation site such as a tendon or ligament. The cylinder may also be placed around an organ. In some embodiments, the cylinder fills in a cylindrical implantation site.
A treatment device 100 shaped as a box may be used to fill an implantation site. For example, the box may be used to fill an implantation site that features an area where tissue was removed by surgery or trauma.
A treatment device 100 shaped as a sphere or an irregular shape may be used to fill or conform to an implantation site. For example, one or more spheres may be inserted into an anatomical defect to fill the defect. The one or more spheres may be mixed with one or more irregularly shaped devices.
The treatment device 100 may be placed at any orientation in or around an implantation site. However, certain orientations of the treatment device 100, specifically the orientations of the elongated synthetic elements 120 within the tissue matrix 110, are more effective at receiving forces upon the implantation site. In some embodiments, elongated synthetic elements 120 oriented substantially perpendicular to a tendon, ligament, incision, or other traumatized tissue receive and protect the traumatized tissue from a greater force than elongated synthetic elements 120 oriented substantially parallel to the traumatized tissue. In some embodiments, the treatment device 100 is oriented such that a majority of the elongated synthetic elements 120 within the tissue matrix 110 are substantially perpendicular to the traumatized tissue of an implantation site. The orientation of the elongated synthetic elements 120 may also be determined by an expressed preference of a user of the treatment device 100.
As a non-limiting example, the treatment device 100 may be implanted along a midline incision of an abdomen after surgery. The treatment device 100 is implanted such that the elongated synthetic elements 120 are oriented substantially perpendicular to the incision. In a perpendicular orientation, the elongated synthetic elements 120 will receive a minority, a majority, or all of the force directed to the area of the incision. Once the treatment device 100 is correctly oriented, the treatment device 100 is sutured to the implantation site with the fixation elements 130.
Examples of various combinations of materials are described below. It will be understood that some of the materials listed can be interchanged in the various embodiments without departing from the intended scope of the invention.
The treatment device 100 can be modified to include a second group of elongated synthetic elements.
As shown, the treatment device 200 includes a tissue matrix 210, a first group of elongated synthetic elements 220, and a second group of elongated synthetic elements 225. In these embodiments, the first group of elongated synthetic elements 220 is aligned perpendicularly to the second group of elongated synthetic elements 225. The second group of elongated synthetic elements 225 may include fixation elements 235 as described above.
The treatment device can be modified to expose the one or more elongated synthetic elements on one or more portions of the top surface of the tissue matrix.
The elongated synthetic elements 320 may be oriented within the tissue matrix 310 according to an intended use of the treatment device 300 or according to the preference or a surgeon, physician, nurse, or other medical professional. In some embodiments, the one or more synthetic elements 320 extend through the tissue matrix 310 such that at least one or more of the elongated synthetic elements 322 extend substantially parallel to the first top surface 312 and the second bottom surface 314 of one or more portions of the tissue matrix 310, and are exposed on one or more portions of the first top surface 312 of the tissue matrix 310. At least one or more elongated synthetic elements 320 may extend through the tissue matrix 310 as described above with respect to
After selecting the tissue matrix, one or more elongated synthetic elements may be inserted through at least a portion of an interior of the tissue matrix. In some embodiments, the one or more elongated synthetic elements are passed through a flexible sheet of tissue matrix such that when the flexible sheet of acellular tissue matrix lies flat, the one or more synthetic elements extend substantially parallel to the first top surface and the second bottom surface within the flexible sheet. In some embodiments, the one or more elongated synthetic elements are inserted through at least a portion of an interior of the sheet of acellular tissue matrix such that the one or more synthetic elements partially extend substantially parallel to the first top surface and the second bottom surface within the flexible sheet, and are partially exposed on the first top surface of the flexible sheet. In some embodiments, the one or more elongated synthetic elements are inserted such that they are substantially parallel with one another.
In some embodiments, the selected tissue matrix is formed around the one or more elongated synthetic elements. In some embodiments, the tissue matrix is formed around a first group of elongated synthetic elements and a second group of synthetic elements is inserted through the formed tissue matrix.
The devices described above further include one or more fixation elements. The fixation elements may extend from the one or more elongated synthetic elements or may be attached to the one or more elongated synthetic elements after the one or more elongated synthetic elements are joined with the tissue matrix. In some embodiments, the fixation elements are utilized to pierce through the tissue matrix and insert the one or more elongated synthetic elements through the tissue matrix.
In some embodiments, one or more elongated synthetic elements 520 partially extend substantially parallel to the first top surface and the second bottom surface within the treatment device 510 and are partially exposed on the first top surface of the treatment device 510. The treatment device 510 is secured within the surgical site 500 such that the bottom surface is adjacent to the exposed connective and/or muscular tissue 545 within the surgical site 500 and the top surface faces away from the exposed connective and/or muscular tissue 545 within the surgical site 500. Orienting the device 510 so that the top surface including exposed elongated synthetic elements faces away from the connective and/or muscle tissue 545 prevents adhesion between the exposed elongated synthetic elements and the exposed connective and/or muscular tissue 545 within the surgical site 500.
This application claims priority to U.S. Provisional Patent Application 62/567,376, which was filed on Oct. 3, 2017, and which is incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62567376 | Oct 2017 | US |
