Cook Biotech, Inc.

Tepha, Inc.

Cook Medical Technologies LLC

Other

Oregon Health & Science University

Cook Incorporated

Bhavin Shah

Umesh H Patel

Said Rizk

Simon F Williams

David P Martin

Amit Ganatra

Chad S McAlexander

Michael C Hiles

Fabio Felix

Matthew Bernasconi

F Joseph Obermiller

Skander Limem

Chad E Johnson

Rhonda Peck

Ryan Dempsey

Katie L Harrigan

Benjamin Patrick Kline

Thomas A Osborne

Brian L Bates

Steven Charlebois

Keith Milner

Clay D Fette

Dusan Pavcnik

John A Kaufman

Jeffrey A Miller

Lal Ninan

Matthew Dubois

Ryan Bernstein

Mark Duncan

Christopher Nelson

Nathan Newman

Paul J Hall

Jeremy Metz

Michelle Chutka

Loran Solorio

Steven Cohen

Joel A Virkler

Likang Chin

Krista Gearhart

Joseph W Zubik

Diana Gail Reynolds

David Tapia

Eric J Rodenberg

Chad S Mcalexander

Mary Beth Wade

A polymeric material fiber includes a polymeric material which is a homopolymer of caprolactone or a copolymer of at least 90% by weight of caprolactone and one or more additional monomers. An implantable mesh includes this fiber alone or combined with one or more additional fiber materials. Methods for treating patients involve implanting the fiber material, for example incorporated in a mesh.

Polycaprolactone-based fibers and implants including same

In certain aspects, the present disclosure provides devices for loading a surgical bolster material. In accordance with some forms, the device includes a tray defining a guide channel for receipt of a bolster material. The guide channel may be configured to align and/or direct the device onto which the bolster material is to be loaded onto the bolster material.

System and methods for supplying surgical staple line reinforcement

Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications.

Methods of orienting multifilament yarn and monofilaments of poly-4-hydroxybutyrate and copolymers thereof

Described are medical devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.

Medical devices and methods useful for applying bolster material

Expandable absorbable implants have been developed that are suitable for breast reconstruction following mastectomy. The implants can be implanted in the vicinity of a tissue expander, for example, by suturing to the detached edge of the pectoralis major muscle to function as a pectoralis extender, and used to form a sling for a tissue expander. The implants, which permit tissue-ingrowth and slowly degrade, can be expanded in the breast using a tissue expander in order to form a pocket for a permanent breast implant. After expansion, the tissue expander can be removed and replaced with a permanent breast implant. The expandable implants help reduce patient discomfort resulting from tissue expansion, and avoid the need to use allografts or xenografts to create the pocket for the tissue expander. The expandable absorbable implant preferably comprises poly-4-hydroxybutyrate or copolymer thereof.

Expandable absorbable implants for breast reconstruction and augmentation

Methods to produce laminates including layers of constructs made from P4HB and copolymers thereof have been developed. These laminates may be used as medical implants, or further processed to make medical implants. The laminates are produced at a temperature equal to or greater than the softening points of the P4HB or copolymers thereof. The layers may include oriented forms of the constructs. Orientation can be preserved during lamination so that the laminate is also oriented, when the laminates are formed at temperatures less than the de-orientation temperatures of the layers. The laminate layers may include, for example, films, textiles, including woven, knitted, braided and non-woven textiles, foams, thermoforms, and fibers. The laminates preferably include one or more oriented P4HB films.

Medical implants including laminates of poly-4-hydroxybutyrate and copolymers thereof

The present invention provides, in certain aspects, medical graft products that incorporate multiple drug depots in and/or on the products. One such product is a sheet graft construct, for example for tissue support that includes a sheet graft material with a plurality of drug depots. The drug depots can be hardened deposits formed directly onto the sheet graft material and/or can be capable of eluting a drug for a minimum of 72 hours.

Drug eluting graft constructs and methods

Calendered surgical meshes comprising polyhydroxyalkanoate polymers have been developed. These meshes, preferably made from poly-4-hydroxybutyrate or copolymer thereof, have a thickness that is between 50 to 99% of the thickness of the mesh prior to calendering, and a burst strength that is not less than 20% of the burst strength of the mesh prior to calendering. The thinner calendered meshes are particularly suitable for surgical applications where a thinner profile mesh with high burst strength is required, and where it is advantageous to have a mesh with a smooth surface. The meshes may be partially or fully resorbable, and are particularly suitable for use in the treatment of pelvic organ prolapse.

Calendered surgical meshes comprising polyhydroxyalkanoates

Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications, including mesh sutures.

Methods of manufacturing mesh sutures from poly-4-hydroxybutyrate and copolymers thereof

Methods to produce perforated collagen coated meshes for use as implants have been developed. The method involves positioning needles through the pores of the mesh, coating the mesh with a collagen solution, freezing the coated mesh, removing the needles from the frozen coated mesh, drying the collagen coated mesh, and optionally cross-linking the coated mesh. The method allows perforated collagen coated meshes to be prepared with variable thickness, and without damage to the surface of the mesh. The perforations of the collagen coated meshes may be designed to prevent the formation of fluid pockets when the coated meshes are implanted, and to permit rapid incorporation into host tissue. The perforated collagen coated meshes may be used for soft tissue repair, regeneration or remodeling including, for example, hernia repair, mastopexy, treatment of urinary incontinence, pelvic floor reconstruction, and ligament and tendon repair.

Methods to produce perforated collagen coated surgical meshes

Described are medical products including an adhesive containing a polypeptide component such as gelatin and a tackiness-providing polyhydroxy compound, such as at least one compound selected from the group consisting of glycerin and fructose. Such medical products can find use as a bolster material for use in conjunction with a surgical fastening device such as a stapler. Other medical applications utilizing a medical product of the invention include tissue repair and pharmaceutical delivery to a desired location. Related methods of manufacture and use are also described.

Absorbable adhesives and their formulation for use in medical applications

Growing community of inventors

West Lafayette, IN, United States of America

Bhavin Shah