WO2016144598A1 - Implant pour l'adhérence de couches de tissu - Google Patents

Implant pour l'adhérence de couches de tissu Download PDF

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Publication number
WO2016144598A1
WO2016144598A1 PCT/US2016/020152 US2016020152W WO2016144598A1 WO 2016144598 A1 WO2016144598 A1 WO 2016144598A1 US 2016020152 W US2016020152 W US 2016020152W WO 2016144598 A1 WO2016144598 A1 WO 2016144598A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
projections
surgical implant
surgical
tissue
Prior art date
Application number
PCT/US2016/020152
Other languages
English (en)
Inventor
Sergei KALSOW
Original Assignee
Montefiore Medical Center
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Montefiore Medical Center filed Critical Montefiore Medical Center
Publication of WO2016144598A1 publication Critical patent/WO2016144598A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body

Definitions

  • Plastic surgery involves reconstruction and improvement of structure and function.
  • the human body has a complex topography, and a plastic surgeon needs to have the technical ability to recreate it.
  • the topography is commonly described by terms such as crests, folds, grooves, prominences, creases, indentations, etc. All of these are basically elevations or depressions of various shapes.
  • a plastic surgeon has a lot of tools in his arsenal to create elevations. He can use fillers, implants, fat injections, etc. However, making depressions, especially precise linear grooves, is tedious and problematic. There is no good way to make grooves. For example, in making an infra-mammary crease after breast reconstruction, a surgeon faces difficulties trying to put in stitches to pull tissues together while at the same time trying to obtain exposure.
  • the present invention addresses the need for improved surgical implants and methods.
  • the present invention provides a device that expands the surgeon's technical ability to create grooves and fill voids between tissues. As such, the surgical procedures become simpler, cheaper, more accurate, and more efficient.
  • the present invention provides surgical implants for promoting adhesion of tissue layers, where the implants comprise a longitudinal body, one or more clusters of projections extending from the body of the implant, and a hook on the end of the projection that is distal to the body of the implant.
  • the invention also provides methods of promoting adhesion of two tissue layers comprising placing the surgical implants between the two layers and applying external pressure on the tissue at the site of the surgical implant to cause the hooks on the ends of the projections to pierce the two tissue layers and hold them together.
  • FIG. 1A Example of the surgical implant, showing the longitudinal body, plurality of clusters of projections extending in different directions from the body of the implant, and hooks at the ends of the projections distal from the body of the implant.
  • FIG. IB Detail of the surgical implant shown in Fig. 1 showing examples of longitudinal body (a), a projection (b), a hook (c), and a cluster of projections (brackets).
  • FIG. 2 Prophetic example of binding two tissue layers together using an example of the implant of the present invention.
  • Top A single cluster of projections is shown between two tissue layers (layer 1 and layer 2).
  • Bottom After application of external pressure (illustrated by downward pointing arrow), e.g., using a finger or surgical instrument, the hooks on the ends of the projections pierce the tissue and hold the two layers together.
  • Fig. 3 Prophetic example of using a finger to apply external pressure to cause the hooks on the ends of the projections to pierce two tissue layers and hold the layers together.
  • Fig. 4 Prophetic example of a linear adhesion created between two tissue layers using an implant of the present invention.
  • FIG. 5 Prophetic example of using an implant of the present invention to eliminate dead space between tissues.
  • the top portion of the figure illustrates implants positioned in the dead space between tissue layers.
  • the bottom portion of the figure illustrates the use of the implant to bind the tissue layers and eliminate dead space.
  • FIG. 6 Prophetic example of using an implant of the present invention to create topographical linear grooves during reconstructive surgery.
  • the arrow points toward the groove.
  • FIG. 7 Prophetic example of using an implant of the present invention for inframmamary fold creation (indicated by arrow) during breast reconstruction.
  • FIG. 8 Prophetic example of using an implant of the present invention to create a supratarsal crease (indicated by arrow) during blepharoplasty.
  • FIG. 9 Prophetic example of using an implant of the present invention to create abdominal cube etchings during abdominal operations.
  • the arrow points to one of the etchings.
  • Fig 10. Prophetic example of using an implant of the present invention for approximation of soft tissue repair, such as muscle repair, following an injury.
  • Fig. 11. Prophetic example of using an implant of the present invention for obliteration of dead space in soft tissue operations.
  • the upper part of the figure illustrates a tumor mass in the tissue.
  • the lower portion of the figure illustrates the use of the implant to eliminate dead space after tumor excision.
  • FIG. 12 Prophetic example of using an implant of the present invention to create naturally looking indentations during a facelift.
  • FIG. 13 Comparison of an example of the present invention with a barbed suture device. Right: The present surgical implant holds tissues together by forces perpendicular to the tissue layers. Left: The barbed suture holds tissue in place by forces parallel to the tissue layers. Forces indicated by arrows.
  • the present invention provides a surgical implant for promoting adhesion of tissue layers, the implant comprising
  • one or more clusters of projections extending from the body of the implant, and a hook on the end of the projection that is distal to the body of the implant.
  • the surgical implant can be made from or include one or more polymers, such as, for example, polymethylmethacrylate, polyethylene and/or polypropylene.
  • the polymer or polymers can be biodegradable polymers such as, for example, polyglycolic acid and/or poly L lactic acid.
  • the surgical implant can be made from or include one or more metals, such as, for example, vitallium and/or nitinol.
  • the body of the implant can be provided in different lengths,
  • the body can be, for example, 1 cm to 100 cm in length. Preferred lengths include 10-50 cm and 40 cm. The lengths can be further cut to a desired size in a surgical setting depending upon the surgical requirments.
  • the body can also be provided in different diameters.
  • the body can be, for example, 0.1 mm to 5 mm in diameter. Preferred diameters include 0.5 to 1.5 mm and 1.0 mm.
  • the ends of the body can be, e.g., sharp or dull.
  • the body can be straight or forked with two or more branches.
  • the projections which extend from the body of the implant, are grouped in clusters.
  • the implant can be provided with different spacings between clusters.
  • the distance between clusters can be, for example, 0.1 mm to 2 cm.
  • Preferred distances between clusters include 3-5 mm and 4 mm.
  • the proj ections can extend at different angles from the body of the implant.
  • the angle between the projections and the body can be, for example, from 30 degrees to 150 degrees. Preferred angles include 75 degrees to 105 degrees and 90 degrees (i.e., at a right angle to the body of the implant).
  • the clusters can consist of a different number of projections.
  • the number of projections in a cluster can vary, for example, from 2 to 12.
  • Preferred clusters include 4-6 projections.
  • the projections can be provided in different lengths.
  • the projections along the body can be the same length or different lengths.
  • the projections in a cluster can be the same length or different lengths.
  • the length of individual projections can vary between, for example, 1 mm to 6 cm.
  • Preferred lengths of the projections include 2-5 mm.
  • the projections can be provided in different diameters.
  • the diameter of the projections can be, for example, 0.1 to 5 mm.
  • Preferred diameters of the projections include 0.5 to 1.5 mm and 1 mm.
  • the projections can be tapered along their length or constant in diameter.
  • the projections can be straight or forked with two or more branches.
  • the projections extend from the body of the implant in different directions.
  • the projections can extend at different angles with respect to other projections.
  • Projections can extend from the body, for example, at an angle of 10 degrees to 350 degrees with respect to other projections.
  • Each projection begins at the body and ends as a hook, a barb, an arrowhead shape, or another shape suitable for attaching to tissue.
  • the projections can include one or more additional hooks (or barbs, arrowhead shapes, or another shape suitable for attaching to tissue) along the length of the projection between the body and the hook at the end of the projection. Apart from the one or more hooks, the projections themselves are smooth.
  • Each hook (or barb, arrowhead shape, or another shape suitable for attaching to tissue) has a sharp end. It is made to pierce through tissue and catch on the tissue so as not pull out. Its anatomy is variable but the function is the same: to pierce and catch tissue. It can have a single projection that does this, or circular or multiple projections.
  • the invention also provides a method of promoting adhesion of two tissue layers comprising placing any of the surgical implants disclosed herein between the two layers and applying external pressure on the tissue at the site of the surgical implant to cause the hooks on the ends of the projections to pierce the two tissue layers and hold them together.
  • the external pressure can be applied, for example, by using a finger or by a surgical instrument.
  • the force is applied perpendicular to the tissue layers.
  • the method has a number of advantageous uses including, but not limited to, eliminating dead space between tissues, creating a topographical linear groove in the tissue, inframmamary fold creation during breast reconstruction, creating a supratarsal crease during blepharoplasty, creating abdominal cube etchings during abdominal operations, creating naturally looking indentations during a facelift, approximation of soft tissue repair following an injury, obliteration of dead space in a soft tissue operation, where the soft tissue can be, for example, muscle, and elimation of dead space following removal of a tumor mass.
  • the invention is a type of suture, absorbable or permanent, which is placed between layers of tissue during surgery, and is then fixed into place with external pressure. It has projections with multiple small hooks pointing in different directions (Fig. 1A and IB). These hooks bind tissues. When fixed, it joins the two layers in a linear fashion. As such it can be used to eliminate dead space or to make topographical creases, such as the inframammary fold during breast reconstruction or a crisp and precise supratarsal crease during a blepharoplasty.
  • the surgical implant device is an alloplastic implant. It is comprises a longitudinal body with multiple hook projections that are capable of securing two layers from all sides (Fig. 2). Upon placement between soft tissue layers, external pressure can be applied, e.g., either with a finger or a surgical instrument to cause the hooks to pierce the tissues (partial thickness) and secure them in place (Fig. 3). The result is a linear adhesion created between the two layers (Fig. 4).
  • the surgical implant can be used to eliminate dead space (Fig. 5). It can also be used to create topographical linear grooves (Fig. 6). The arrow points to the creation of a natural appearing crease or groove. Additional advantageous features of the invention are elaborated below.
  • the surgical implant can be manufactured in different sizes to allow for various applications. Just like sutures are manufactured in different sizes, the present surgical implant will have different sizes also. A surgeon would choose the size and length based on indication. The length could be further trimmed as needed.
  • Additional prophetic applications include, e.g., inframmamary fold creation during breast reconstruction (Fig. 7), supratarsal crease during blepharoplasty (Fig. 8), abdominal cube etching during abdominal operations (Fig. 9), approximation of soft tissue repair such as muscle during injuries (Fig. 10), obliteration of dead space in various soft tissue operations (Fig. 11), and creation of naturally looking indentations during a facelift (Fig. 12).
  • Barbed sutures are made to be driven through tissues using needles at edges of the cut tissue.
  • the present surgical implant is placed between layers and is secured in place with pressure.
  • the barbed suture devices cannot be placed in the middle of the tissue layers and as such are not useful in making grooves.
  • the present surgical implant is made to be placed in the middle of layers and to make crisp depressions.
  • the present surgical implant is not attached to needles and is not driven through tissue with needles but pierces the tissue with pressure.
  • barbed sutures hold tissue in place by parallel forces (on the suture)
  • the present surgical implant holds tissue together by perpendicular forces (on the hooks) (Fig 13).

Abstract

L'invention concerne des implants chirurgicaux et des procédés pour activer l'adhérence de couches de tissu, les implants comprenant un corps longitudinal, un ou plusieurs groupes d'éléments saillants s'étendant depuis le corps de l'implant, et un crochet sur l'extrémité de l'élément saillant qui est distal par rapport au corps de l'implant ; l'application d'une pression externe sur le tissu au niveau du site de l'implant chirurgical a pour effet que les crochets sur les extrémités des éléments saillants percent les couches de tissu et les retiennent ensemble.
PCT/US2016/020152 2015-03-10 2016-03-01 Implant pour l'adhérence de couches de tissu WO2016144598A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562130642P 2015-03-10 2015-03-10
US62/130,642 2015-03-10

Publications (1)

Publication Number Publication Date
WO2016144598A1 true WO2016144598A1 (fr) 2016-09-15

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Family Applications (1)

Application Number Title Priority Date Filing Date
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WO (1) WO2016144598A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4259959A (en) * 1978-12-20 1981-04-07 Walker Wesley W Suturing element
US20030149447A1 (en) * 2002-02-01 2003-08-07 Morency Steven David Barbed surgical suture
US20030153947A1 (en) * 2002-02-14 2003-08-14 Tomoaki Koseki Sternum suture material and its manufacturing method
US20060135995A1 (en) * 2002-09-30 2006-06-22 Ruff Gregory L Barbed Suture in Combination with Surgical Needle
US20070224237A1 (en) * 2006-03-24 2007-09-27 Julia Hwang Barbed sutures having a therapeutic agent thereon
US20110022086A1 (en) * 2007-10-31 2011-01-27 Angiotech Pharmaceuticals, Inc. Combining synthetic, natural polymers and recombinant polymers to form monofilament and multifilament self-retaining sutures
US8679157B2 (en) * 2006-09-06 2014-03-25 Covidien Lp Bioactive substance in a barbed suture

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4259959A (en) * 1978-12-20 1981-04-07 Walker Wesley W Suturing element
US20030149447A1 (en) * 2002-02-01 2003-08-07 Morency Steven David Barbed surgical suture
US20030153947A1 (en) * 2002-02-14 2003-08-14 Tomoaki Koseki Sternum suture material and its manufacturing method
US20060135995A1 (en) * 2002-09-30 2006-06-22 Ruff Gregory L Barbed Suture in Combination with Surgical Needle
US20070224237A1 (en) * 2006-03-24 2007-09-27 Julia Hwang Barbed sutures having a therapeutic agent thereon
US8679157B2 (en) * 2006-09-06 2014-03-25 Covidien Lp Bioactive substance in a barbed suture
US20110022086A1 (en) * 2007-10-31 2011-01-27 Angiotech Pharmaceuticals, Inc. Combining synthetic, natural polymers and recombinant polymers to form monofilament and multifilament self-retaining sutures

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