EP2051657A2 - Dispositif de réparation de tissu - Google Patents

Dispositif de réparation de tissu

Info

Publication number
EP2051657A2
EP2051657A2 EP07789016A EP07789016A EP2051657A2 EP 2051657 A2 EP2051657 A2 EP 2051657A2 EP 07789016 A EP07789016 A EP 07789016A EP 07789016 A EP07789016 A EP 07789016A EP 2051657 A2 EP2051657 A2 EP 2051657A2
Authority
EP
European Patent Office
Prior art keywords
tissue repair
repair device
tissue
filiform
micrometres
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP07789016A
Other languages
German (de)
English (en)
Inventor
James Browning
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coloplast AS
Original Assignee
MPathy Medical Devices Ltd
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 MPathy Medical Devices Ltd filed Critical MPathy Medical Devices Ltd
Publication of EP2051657A2 publication Critical patent/EP2051657A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings

Definitions

  • Distortion includes undesired twisting, pulling, elongation or tearing of the tissue repair device, as observed by the naked eye.
  • the tissue repair device can be provided with a width and thickness such that, in use, the device can be moved through soft tissue during placement of the device and in the first two to three postoperative days with a force less than or equal to 50 N, less than or equal to 40 N, less than or equal to 30 N or less than or equal to 25 N.
  • the force required to move a tissue repair device may be determined using a suitable tissue model or tissue surrogate model, and a force gauge. Applying a constant rate of movement to a device to be tested, the device can be moved through the tissue model or tissue surrogate model and the force generated determined.
  • the coating can be applied as a film to the device.
  • a film can contain polymers and / or compolymers of lactides, glycolides, caprolactone, triimethylene carbonate, or the like.
  • At least one filament preferably a di-filament
  • At least a second projection or second plurality of projections can be provided on the device wherein said second projection(s) extend outwardly from the body of the device at an angle greater than 90 9 .
  • the at least second or second plurality of projections can be positioned at a predetermined portion or portions of the device.
  • the shaped projection may be triangular wherein the base of the triangular shaped projection is provided such that it extends perpendicularly from the longitudinal axis of the device.
  • the base of the triangular shaped projection can be wider than the width of the tissue repair device at that point, but the thickness of the triangular shaped projection can be the same as the device.
  • the lateral projections from the device will provide for unidirectional movement of the device.
  • the interstices may be in the range of 50 ⁇ m to 75 ⁇ m in cross-sectional width.
  • Pores or slits provided on the surface of the filiform may extend through the filiform or alternatively extend into a central portion of the filiform.
  • a microgroove can be of width between 0.5 ⁇ m to 7 ⁇ m and of depth 0.25 ⁇ m to 7 ⁇ m. More preferably a microgroove can be 5 ⁇ m in width and 5 ⁇ m in depth. Suitably a plurality of microgrooves may be aligned such that they are substantially parallel with each other.
  • an absorbable material can comprise natural proteins and or natural biopolymers.
  • the material may be formed from filaments comprising polyester polymers, polypropylene polymers and the like, copolymers, or blends thereof.
  • Bioactive substances include, but are not limited to, enzymes, proteins, peptides, either naturally occurring, recombinant or synthetic, pharmacological agent including, but not limited to; growth factors and wound healing agents.
  • the bioactive substance may stimulate cell growth, promote healing and/or tissue repair.
  • the bioactive substance may be platelet rich plasma, cartilage-derived morphogenic proteins, recombinant human growth factors, chitosan, silver compounds and the like and combinations thereof.
  • Bioactive substance can be applied to the device during or post manufacture of the device.
  • tissue ingrowth into the tissue repair device may be accelerated.
  • At least one tissue repair device of the first aspect of the invention may further comprise a support portion, conjoined to the tissue repair device.
  • the support portion can be of greater width than the tissue repair device and need not have the same structural characteristics.
  • the mesh may comprise spaces between the . strands of around 1 to 10mm.
  • a mesh with strands spaced apart by 1 to 10mm is advantageous as the overall mass of the support portion of the tissue repair device may be reduced.
  • the strands can be spaced apart to form spaces between the strands in the range 1.8 to 2 mm.
  • a support may be fixed to a tissue repair device by the projection.
  • Such a terminal expanded portion may be smoothed at a surface such that, for example, a filament or filaments of the filiform of the tissue repair device and/or the support portion do not project from the device or support or the filament(s) do not unravel.
  • the kit may comprise at least one button for fixation of the tissue repair device at the skin.
  • the tissue repair device of such embodiments can be held in position at the skin by the button or suture.
  • the kit may comprise a collar device wherein the collar device includes a depression arranged to receive the button wherein said collar device has a passage extending therethrough, which can accommodate a portion of the tissue repair device.
  • the tissue repair device can be used to attach medical devices for example, but not limited to a prosthesis or implant, to tissue, tissue to tissue, or a first medical device, for example a prosthesis or implant to a second medical device.
  • a method of connecting a first fixing point to a second fixing point comprising:
  • tissue repair device comprising a filiform having a longitudinal axis and a transverse width wherein at least part of said filiform comprises interstices on a surface of the filiform wherein said interstices have a cross-sectional width in the range of 50 micrometres to 200 micrometres and a force of at least 30 N can be exerted along the longitudinal axis of the device without distortion of the device;
  • the method can comprise the step of adjusting the position of the device within the body.
  • the position of the tissue repair device held between the first and second fixing points can be adjusted within 72 hours following insertion of the device into a body.
  • the step of adjusting can occur after 2 hours following insertion of the device into the body, after 4 hours following insertion of the device into the body, after 8 hours following insertion of the device into the body, after 16 hours following insertion of the device into the body, after 24 hours following insertion of the device into the body.
  • a first and second tissue repair device comprising a filiform having a longitudinal axis and transverse width wherein at least part of said filiform comprises interstices on a surface of the filiform wherein said interstices have a cross-sectional width in the range of 50 micrometres to 200 micrometres and a force of at least 30 N can be exerted along the longitudinal axis of the device without distortion of the device and a support portion interposed between said first and second devices, wherein said support portion is conjoined to one end of each of the first and second devices,
  • Suitably embodiments of the device and methods of the invention can be used for treatment of prolapse, in particular uterovaginal prolapse.
  • Suitably embodiments of the device and methods of the invention can be used for treatment of male urinary incontinence.
  • Suitably embodiments of the device and methods of the invention can used for treatment of rectoanal sphincter disorders.
  • an implant can be provided wherein the implant comprises a short segment of a mesh support portion 4 interposed between a first tissue repair device of the present invention 6 and a second tissue repair device of the present invention 8.
  • the implant is described in detail below in relation to its use to support the urethra to treat urinary incontinence, the skilled person will understand that implants including the features described could be used to support any suitable anatomical structure or defined tissue, for example, but not limited to repair a pelvic floor, for treatment of cystoceles and rectoceles and prolapse conditions.
  • the support portion 4 of the implant 2 is positioned under the urethra.
  • the support portion 4 is around 4 - 8 cm in length and 0.5 cm to 1.2 cm in width.
  • tissue repair devices are substantially ovoid in cross section. This is advantageous, as it minimises the likelihood of damage to surrounding tissue by the device during insertion, post-operative adjustment and beyond.
  • devices of other cross sections may be used provided that the surface of the device allows its movement within the patient during implantation and for around two days post implantation without trauma to the tissues surrounding the device.
  • Figure 4 shows an implant comprising non-absorbable and absorbable sections.
  • the non-absorbable section from the midpoint of the mesh support portion and the tissue repair device (sections a and b) is around 4 to 14cm and the absorbable portion of the tissue repair device, made from an absorbable polymer, (section c) is around 2 to 25cm.
  • Figure 5 shows an implant as described implanted in the body using a retropubic procedure.
  • Figure 6 shows an implant as described implanted in the body using an obturator foramen procedure.
  • a needle introducer such as a Nottingham needle
  • a first device is attached is inserted through the incision, over to the first obturator foramen and passed through the obturator foramen close to the inferior pubic ramus, through the obturator muscle, and through the perineal skin over a patient's first obturator foramen.
  • tissue repair devices In the treatment of prolapse, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more tissue repair devices can be conjoined to a support portion.
  • the support portion may be a mesh as described herein and as shown in Figure 7 and in close up in Figure 3.
  • tissue repair devices to a support portion, as illustrated in Figure 7, can be advantageous as they can each be used to provide an additive amount of support to the support portion.
  • the tensile strength required by each tissue repair device can therefore be reduced.
  • the multiple tissue repair devices conjoined to a support portion are inserted by
  • a first tissue repair device into pelvic paravaginal fibro-fatty tissue, for example the retropubic space, para rectal space, or ischiorectal fossa, and fixing the same into structural tissue or exiting these spaces, through the skin, outside the body
  • a second tissue repair device into pelvic parvaginal fibro-fatty tissue, for example the retropubic space, para rectal space, or ischiorectal fossa, and fixing the same into structural tissue or exiting these spaces, through the skin, outside the body
  • tissue repair devices such in the tissue to obtain suitable placement and tension.
  • Adjustment may be made for around two to three days following insertion of the devices in the body.
  • ends of the tissue repair device not conjoined to the mesh tape for example the first end 52 of the first tissue repair device 50, can be tapered to a point. This can be advantageous to attach the tissue repair device to a needle introducer to allow insertion of the tissue repair device in the body.
  • the first tissue repair device is formed from two filaments 55 which have been intertwined, using a warp knit, such that the filaments provide strands 56 with interstices 57 in the range 50 micrometres to 200 micrometres.
  • the strands 56 of intertwined filaments 55 are then further intertwined together such that multiple strands are joined together wherein the spaces 58 between the strands are in the range of 50 micrometres to 200 micrometres.
  • the multiple strands joined together as described provide a filiform having a longitudinal axis (L) between the first end 52 and the second end 54 and a transverse width (W), perpendicular to the longitudinal axis of about 3 mm.
  • the thickness of the device cannot be seen, but this is in the range of 20 to 35 micrometres.
  • This thickness of device allows fibroblasts which enter into the interstices between the filaments and the spaces between the strands to extend across the thickness of the device from a first surface to a second surface to hold the device in place in the tissue.
  • the tensioning of the intertwining of the strands is reduced such that the spaces between the strands begin to increase such that the spaces between strands formed by the filaments have a cross-sectional width in the range 1 mm to 10 mm (a) at the support portion of mesh tape 60.
  • a projection can be triangular shaped 82 wherein the base 84 of the triangular shaped projection is provided such that it extends perpendicularly from the longitudinal axis of the device 50.
  • the base of the triangular shaped projection is wider than the width of the tissue repair device at that point, but the thickness of the triangular shaped projection is the same as the device.
  • the lateral projections from the device will provide for unidirectional movement of the device.

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de réparation de tissu à utiliser dans des procédés chirurgicaux. Le dispositif de réparation de tissu comprend un élément filiforme ayant un axe longitudinal et une largeur transversale, une force d'au moins 30 N pouvant être exercée le long de l'axe longitudinal du dispositif sans déformation du dispositif, et au moins une partie de l'élément filiforme précité comprenant des interstices sur une surface de l'élément filiforme, les interstices ayant une largeur en coupe transversale dans la plage de 50 micromètres à 200 micromètres. Dans des procédés chirurgicaux, des caractéristiques du dispositif peuvent fournir le mouvement de lubrification du dispositif dans le tissu environnant pendant un laps de temps allant jusqu'à 72 heures, fournissant l'ajustement du dispositif et le positionnement du dispositif dans le corps après sa mise en place initiale. Ensuite, une traction du dispositif sur le tissu environnant peut être obtenue puisque les caractéristiques du dispositif amènent le dispositif à agir comme un échafaudage pour la croissance de tissu dans et autour de la structure du dispositif.
EP07789016A 2006-07-11 2007-07-11 Dispositif de réparation de tissu Withdrawn EP2051657A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0613653A GB0613653D0 (en) 2006-07-11 2006-07-11 Tissue regeneration repair device
PCT/GB2007/002589 WO2008007086A2 (fr) 2006-07-11 2007-07-11 Dispositif de réparation de tissu

Publications (1)

Publication Number Publication Date
EP2051657A2 true EP2051657A2 (fr) 2009-04-29

Family

ID=36926741

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07789016A Withdrawn EP2051657A2 (fr) 2006-07-11 2007-07-11 Dispositif de réparation de tissu

Country Status (3)

Country Link
EP (1) EP2051657A2 (fr)
GB (1) GB0613653D0 (fr)
WO (1) WO2008007086A2 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2811218B1 (fr) 2000-07-05 2003-02-28 Patrice Suslian Dispositif implantable destine a corriger l'incontinence urinaire
US8167785B2 (en) 2000-10-12 2012-05-01 Coloplast A/S Urethral support system
US20060205995A1 (en) 2000-10-12 2006-09-14 Gyne Ideas Limited Apparatus and method for treating female urinary incontinence
GB0025068D0 (en) 2000-10-12 2000-11-29 Browning Healthcare Ltd Apparatus and method for treating female urinary incontinence
GB0108088D0 (en) 2001-03-30 2001-05-23 Browning Healthcare Ltd Surgical implant
AU2003269934A1 (en) 2002-08-02 2004-02-23 C.R. Bard, Inc. Self anchoring sling and introducer system
GB0307082D0 (en) 2003-03-27 2003-04-30 Gyne Ideas Ltd Drug delivery device and method
GB0411360D0 (en) 2004-05-21 2004-06-23 Mpathy Medical Devices Ltd Implant

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5569273A (en) * 1995-07-13 1996-10-29 C. R. Bard, Inc. Surgical mesh fabric
US6042592A (en) * 1997-08-04 2000-03-28 Meadox Medicals, Inc. Thin soft tissue support mesh
US20020042658A1 (en) * 2000-10-10 2002-04-11 Tyagi Narendra S. Hernia repair mesh prosthesis, and method of using same
DE10107521A1 (de) * 2001-02-17 2002-09-05 Inst Textil & Faserforschung Zugstabiles elastisches Band
GB0108088D0 (en) * 2001-03-30 2001-05-23 Browning Healthcare Ltd Surgical implant
US6755781B2 (en) * 2001-07-27 2004-06-29 Scimed Life Systems, Inc. Medical slings
EP1653880B1 (fr) * 2003-08-14 2009-04-29 Boston Scientific Limited Echarpe medicale

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2008007086A3 *

Also Published As

Publication number Publication date
WO2008007086A3 (fr) 2008-03-06
GB0613653D0 (en) 2006-08-16
WO2008007086A2 (fr) 2008-01-17

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