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EP-4384082-B1 - SYSTEMS, KITS, AND METHODS FOR COATING SUTURES WITH MEDICINAL COMPOUNDS IMMEDIATELY PRIOR TO SUTURE IMPLANTATION

EP4384082B1EP 4384082 B1EP4384082 B1EP 4384082B1EP-4384082-B1

Inventors

  • SCALZO, JR., Howard
  • POKROPINSKI, JR., Henry
  • KRIKSUNOV, LEO

Dates

Publication Date
20260506
Application Date
20220802

Claims (14)

  1. A suturing system, comprising: An elongated flexible suture (10) having a connecting end attached to a needle (100) and an opposing free end (10a), said suture co-packaged with a pierceable container (200) containing a medicant solution, characterized in that said pierceable container further contains a sponge (55) wetted with said medicant solution.
  2. The suturing system of claim 1, wherein said suture is absorbable, non-absorbable, monofilament, braid, barbed, or combinations thereof.
  3. The suturing system of claim 1, wherein said medicant is anti-microbial or anti-bacterial agent.
  4. The suturing system of claim 3, wherein said medicant comprises chlorhexidine, polyhexamethylene biguanide, octenidine, silver particles, silver salts, triclosan, and combinations thereof.
  5. The suturing system of claim 1, wherein said pierceable container comprises a pierceable septum (212).
  6. The suturing system of claim 3, wherein said medicant solution comprises a rapidly evaporating solvent, optionally wherein said solvent is ethanol.
  7. The suturing system of claim 1, wherein said suture is a coreless braid having a hollow core.
  8. The suturing system of claim 1, wherein said suture is a monofilament suture, having surface features configured to increase uptake of said medicant solution by said suture, optionally wherein said surface features comprise grooves, apertures, cavities, surface roughening features, and combinations thereof.
  9. The suturing system of claim 1, wherein said suture comprises a coating configured to increase uptake of said medicant solution by said suture.
  10. The suturing system of claim 1, wherein said suture comprises a coating reactive with any of ingredients of said medicant solution increasing uptake of said medicant by said suture.
  11. The suturing system of claim 1, wherein said container contains a first medicant a first combination of medicants in said medicant solution, and said suture is pre-coated by a second medicant, said second medicant can be the same or different from said first medicant or said first combination of medicants.
  12. A method of coating the suture of the suturing system of claim 1, comprising the steps of: 1) Providing a suturing system according to claim 1; 2) Gripping the needle manually or with a suture gripper; 3) Piercing said pierceable container with said needle; 4) Entering said pierceable container with said needle and pulling said needle through said pierceable container; 5) Exiting said pierceable container with said needle in a different spot; 6) Pulling said suture through said pierceable container behind said needle, thus exposing said suture to said medicant solution inside said pierceable container; 7) Removing all suture from said pierceable container thus forming suture wetted with said medicant solution and retaining at least some medicant on said suture; and Optionally allowing at least a portion of said solution to evaporate.
  13. The method of claim 12, wherein pulling said suture through said pierceable container behind said needle, results in removing an excess of said medicant solution from said suture as said suture exits said pierceable container through interaction of said suture with a wall of said pierceable container or with a pierceable septum closing said pierceable container.
  14. The methods of any one of claims 12 to 13 comprising sterilizing said suture and said container separately, optionally wherein said suture and said pierceable container are sterilized by a different sterilization technique.

Description

FIELD The field of art to which this invention relates is absorbable or non-absorbable medical devices, such as monofilament sutures or multifilament such as braided sutures, more specifically surgical sutures configured for coating or impregnating with beneficial agents or medicants immediately prior to the suture installation into the tissue. BACKGROUND Surgical sutures and attached surgical needles are well known in the art for use in a variety of conventional surgical procedures. For example, such sutures may be used to approximate tissue about incisions or lacerations in epidermal layers and underlying fascia layers, join blood vessel ends, attach tissue to medical devices such as heart valves, repair body organs, repair connective tissue, etc. Conventional surgical sutures may be made from known biocompatible materials, particularly synthetic and natural biocompatible polymeric materials, which may be non-absorbable or absorbable. Examples of synthetic non-absorbable polymeric materials useful to manufacture non-absorbable sutures include polyesters, polyolefins, polyvinylidene fluorides and polyamides. Further examples of non-absorbable materials are polyethylene, polypropylene, nylon, and similar polymers. Examples of synthetic absorbable polymeric materials useful to manufacture absorbable sutures include polymers and copolymers made from lactones such as the lactides, glycolide, p-dioxanone, epsilon-caprolactone, and trimethylene carbonate. The term absorbable is meant to be a generic term, which may also include implantable devices that bioabsorbable, resorbable, bioresorbable, degradable or biodegradable in the living body or tissue. The term non-absorbable is meant for implantable devices that are permanently installed in the living body or tissue. Sutures are preferred by surgeons for use in many surgical procedures because of several advantages and properties possessed by such sutures. Absorbable sutures must be capable of providing the desired tensile strength in vivo for a sufficient period of time to allow for effective tissue healing. Wound healing is dependent on the nature of the specific tissue as well as the healing characteristics of the individual undergoing the surgical procedure. For example, poorly vascularized tissue is likely to heal more slowly than highly vascularized tissue; likewise, diabetic patients and the elderly tend to heal more slowly as well. There are thus opportunities to provide suture materials that can match the healing characteristics of a variety of wounds. Any implant, such as a suture, appears as a foreign body to the patient's immune system. In addition, it is known that implantable medical devices, including sutures, may provide a platform for the attachment of bacteria and the subsequent formation of bacterial biofilms. It was found beneficial for sutures to have antimicrobial properties. Surgical sutures are designed to have the requisite physical characteristics to assure desirable and efficacious in vivo behavior. Absorbable sutures need to retain appropriate tensile strength during the required healing period; this is typically characterized as breaking strength retention (BSR). In order to obtain the required design properties, it is necessary to provide absorbable polymers and manufacturing processes that will yield absorbable sutures with the required properties. Likewise, the retention of mechanical properties, including, e.g. tensile strength and knot strength, post-implantation, is often a very important and critical feature of an absorbable medical device. The device must retain mechanical integrity until the tissue has healed sufficiently. In some bodily tissues, healing occurs more slowly, requiring an extended retention of mechanical integrity. As mentioned earlier, this is often associated with tissue that has poor vascularization. Likewise, there are other situations in which a given patient may be prone to poor healing, e.g., the diabetic patient. U.S. Patent No. 8997978 "Medical device package" discloses a medical device package comprising: a medical device; at least one solid self-contained agent in a form selected from the group consisting of capsule, tablet, pellet, and pressed powders; a container having an area configured for receiving the medical device, and the at least one solid self-contained agent; and a port for permitting the sterile passage of a contact material between the outside of the container and the at least one solid self-contained agent. U.S. Patent Publication No. 2009/0209031A1 "MEDICAL DEVICE PACKAGE" discloses a package for a medical device, the package capable of sustaining viable cells, the package comprising: a first container configured to receive a medical device and to sustain at least one viable cell; a fluid port in communication with the first container for allowing sterile passage of an agent to the medical device and for maintaining cell viability. U.S. Patent Publication No. 2007/0170080A1 "Medical