WO2017172688A1 - Appareil et procédé pour coupler un tissu mou à un os - Google Patents

Appareil et procédé pour coupler un tissu mou à un os Download PDF

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Publication number
WO2017172688A1
WO2017172688A1 PCT/US2017/024431 US2017024431W WO2017172688A1 WO 2017172688 A1 WO2017172688 A1 WO 2017172688A1 US 2017024431 W US2017024431 W US 2017024431W WO 2017172688 A1 WO2017172688 A1 WO 2017172688A1
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WO
WIPO (PCT)
Prior art keywords
suture
construct
bone
tails
passage
Prior art date
Application number
PCT/US2017/024431
Other languages
English (en)
Inventor
Brett Sanders
Original Assignee
Brett Sanders
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 Brett Sanders filed Critical Brett Sanders
Publication of WO2017172688A1 publication Critical patent/WO2017172688A1/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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • 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
    • A61B2017/0618—Sutures elastic, e.g. stretchable
    • 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
    • A61B2017/06185—Sutures hollow or tubular
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone

Definitions

  • the present disclosure relates to an apparatus and method for coupling soft tissue to bone, such as repairing a torn rotator cuff or other tendons.
  • Arthoscopic procedures are commonly employed to secure soft tissue to bone.
  • the present invention pertains to an apparatus and method for reattaching tendon to bone through the use of transosseous tunnel arthroscopically without the requirement of special hardware fasteners, such as hard suture anchors and hard suture buttons, as required by prior art techniques as disclosed in US Patent Nos. 7,601,165; 7,658,751; 8,118,836; 8,608,777 and 8,672,968. It is accordingly an object of the present teachings to provide an alternative apparatus and method for coupling soft tissue to bone with flexible suture elements without the additional requirement of suture anchoring hardware.
  • a flexible member for coupling tissue which, in its most basic embodiment, is comprised of a collapsible self- locking flexible construct which has a through passage defined therethrough from a first end thereof to a second end thereof, and includes leads or suture tails respectively secured to and extending from the first and second ends of the construct.
  • the collapsible self-locking flexible construct is actuated by applying opposed tensile load to the suture tails, thereby placing the construct under tensile load, which collapses the construct from a first open profile to a second closed engaging profile for locking suture elements received in the through passage of the construct.
  • a flexible suture shuttle is received in and passes through the through passage of the construct with opposite ends of the suture shuttle exposed beyond the first and second ends of the construct for engaging and shuttling suture elements through said through passage from either end.
  • the collapsible self-locking construct in one embodiment may be constructed as a braided body. However, constructs of different construction are usable as taught in the prior art. Padding, in the form of tape or various suture configurations, may be secured to one or more of the suture tails at regions where they engage the soft tissue.
  • the flexible suture shuttle in one embodiment may be provided by an endless loop of suture. Other flexible suture shuttle devices may be substituted which also provide a means to temporarily attach other suture elements to either end of the suture shuttle in order to draw them through the through passage of the collapsible self-locking flexible construct in either direction. Soft tissue is coupled to bone with this flexible member by providing a through passage or bore through bone to which the soft tissue or tendon is to be attached.
  • the construct is positioned within the bone bore with the suture tails of the construct respectively exposed from opposite ends of the bone bore. Thereafter free ends of the exposed suture tails may be respectively passed through the tissue to be coupled and on through the through passage of the construct from opposite ends of the construct and out opposite ends of the bone bore with the sequential use of multiple suture shuttles.
  • the free ends of the suture tails which extend from opposite ends of the bone bore are simultaneously pulled, thereby placing the construct under tensile load and collapsing the construct to lock portions of the suture tails, and any additional suture elements, contained in the through passage of the construct to thereby couple the tissue to the bone without the required use of any suture anchor or suture button hardware.
  • two adjacent through bone bores may be provided in the bone with two of the afore-described flexible members respectively positioned or received in the bone bores. Tissue is then secured to the bone in the same manner.
  • the free ends of the respective suture tails may be passed through the through passage of an opposite one of the collapsible self-locking flexible constructs. This permits the crossing of suture elements between the respective bone bores in order to provide a more secure coupling of the soft tissue to the bone by the suture elements which are engaging the tissue to be attached.
  • Hard protective collar elements may be positioned in one or more of the openings of the bone bore or bone bores in order to prevent migration of or cutting of the bone by the suture elements exiting the bone bores.
  • one or more cinch rings may be positioned around the suture elements exiting one or more of the bone bores and the cinch rings are crushed to lock the suture elements in position. Friction in the construct provides fixation in addition to suture knots or other external fixation constructs.
  • FIG. 1 illustrates a plan view of the basic flexible member for coupling tissue
  • FIGS. 2 though 5 are sequential illustrations showing how the basic flexible member of FIG. 1 is applied to affix a rotator cuff tendon to a humeral head using the present flexible member;
  • FIG. 6 illustrates an enlarged sagittal view of the upper portion of a humerus with a rotator cuff tendon affixed to the humerus head using the flexible member illustrated in FIGS. 1 through 5; and [0012]
  • FIG. 7 illustrates an enlarged sagittal view of the upper portion of a humerus with a rotator cuff tendon affixed to the humerus using multiples of the present flexible member.
  • the flexible member 10 for coupling tissue includes the collapsible suture self-locking flexible construct 11 which is made of a braided body having a tubular configuration constructed of polyethylene or other suitable fibers and which defines a longitudinally formed through passage 12 having a lead aperture 13 shown at the left side of construct 11 and a trailing aperture 14 at the right side of the construct 1 1.
  • the figure illustrates the left side of the braided body construct 11 being cut away to disclose the interior passage 12 and the suture shuttle 15 consisting of an endless loop of flexible suture passing therethrough, with its opposite ends 16 and 17 completely exposed from opposite ends of construct 11.
  • Braided construct 11 is constructed and braided whereby when leading lead or suture tail 18 and trailing lead or suture tail 19 are pulled outwardly and simultaneously in opposite directions, the braided construct 11 constricts about the parallel portions of the suture elements contained within the longitudinal passage 12, since the leading and trailing suture tails 18 and 19 are respectively connected to fibers of opposite twist and extension within the braided construct 11.
  • the constriction of braided construct 11 reduces the diameter of the longitudinal passage 12 thus forming a mechanical interface between the exterior surface of the fibers of opposite direction, extension and wind in construct 1 1 whereby the construct 1 1 collapses and the interior surface of the longitudinal passage 12 constricts in tight locking engagement with any suture elements, such as sutures or leads, passing therethrough.
  • the braided construct 11 functions in a similar manner as the well known toy which is generally referred to as the Chinese finger lock of trap.
  • the right side end of braided construct 11 is secured to a C-shaped steel cinch ring 20 which services two functions.
  • the metal cinch ring 20 first of all has portions 20' in the form of a C-shaped sleeve which serves as a stop that engages the cortex of the bone to prevent bone cut through the bone by sutures or leads passing through construct 11 , and secondly serves as a clamping ring which may be clinched shut as by a pair of plyers to tightly clamp and retain any sutures or leads passing therethough in order to ensure locking capabilities of the construct 11.
  • FIGS. 2 through 5 Other locking mechanisms can also be utilized in place of cinch ring 20, such as a screw placed inside an end aperture of construct 1 1, or a knot mechanism.
  • multiple collapsible braided constructs 11 can be used in conjunction with each other and locked together in a "daisy chain", as will be illustrated hereinafter with reference to FIG. 7.
  • FIGS. 2 through 5 Reference will now be made sequentially to FIGS. 2 through 5 in order to illustrate how the flexible member 10 is singularly applied to bone structure in order to secure soft tissue to bone.
  • humeral head 30 is schematically illustrated together with torn rotator cuff tendons 31 wherein the tendons of the cuff have been torn away from connection with head 30, the task being the re-attachment of torn rotator cuff tendons 31 to humeral head 30 by utilizing the flexible member 10.
  • Bone bore 32 is first created through head 30 in any desired conventional manner and an endless transosseous suture loop, which provides first suture shuttle 33, is transosseously passed through bone bore 32 whereby opposite ends 34 and 35 thereof are exposed as illustrated.
  • suture tail 18, together with end 16 of endless loop suture shuttle 15 are passed through open loop end 35 of suture shuttle 33 as illustrated in FIG. 2.
  • end 34 of suture shuttle 33 is pulled firmly in the direction of arrow 36 to thereby pull the opposite end 35 with the suture tail 18 and suture shuttle end 16 entirely through bone bore 32, thereby completely positioning construct 1 1 within bone bore 32 as illustrated in FIG. 3.
  • Suture shuttle end 16, together with suture tail 18 are completely drawn through bone bore 32 and are thereby exposed at the opposite ends of bone bore 32 as illustrated in FIG. 3.
  • suture tail 18 and end 16 of suture shuttle 15 are also passed through a puncture passage or passages made through the free end of rotator cuff tendons 31 as is also illustrated in FIG. 3.
  • the split metal cinch ring 20 rests against the cortex of bone head 30 with its sleeve portion 20' received in the opening of bone bore 32, thereby acting as a stop, and additionally preventing any leads or sutures exiting through ring 20 from cutting into the cortex of bone head 30.
  • cinch ring 20 need not be provided with sleeve portion 20' if so desired.
  • trailing suture tail 19 is passed through the open loop end 16 of suture shuttle 15.
  • suture shuttle 15 is grasped and pulled continuously in the direction of arrow 40 to thereby pull suture tail 19 all the way through the central through passage 12 of construct 11 together with the captured end of suture tail 19 and captured suture loop end 35 of suture shuttle 33 to thereby obtain the result and configuration illustrated in FIG. 4 wherein suture tail 19, after being entirely passed through construct 11 , is tightly snugged or pulled as indicated by arrow 41 in FIG. 4 to snugly secure the free end of rotator cuff tendons 31 to head 30 as illustrated,
  • suture tail 18 is then passed downwardly through the open loop end 35 of suture shuttle 33 as illustrated in FIG. 4. Thereafter the free end 34 of suture shuttle 33 is then firmly grasped and pulled as indicated by arrow 43 to thereby entirely pull suture shuttle 33 through the central through passage 12 of construct 1 1 together with the captured suture tail 18 and the capture loop end 16 of suture shuttle 15, thereby ultimately obtaining the configuration illustrated in FIG. 5 wherein both suture tails 18 and 19 snugly secure the free end of rotator cuff tendons 31 to head 30.
  • suture tails 18 and 19 are simultaneously pulled under tension as indicated by arrows 46 and 47 which not only tightly snugs up the suture tails 18 and 19 to securely secure the free end of cuff tendons 31 to head 30, but in addition, cause the braided body of construct 11 to stretch out and collapse the construct and thereby constrict and automatically cause longitudinal through passage 12 to constrict about suture tails 18 and 19 and suture shuttle 15 (referred to in combination as suture elements) confined therein, whereby they are mechanically retained and locked therein against possible reversal of movement of suture tails 18 and 19, thereby permanently securing the free end of rotator cuff tendons 31 to bone head 30.
  • suture elements referred to in combination as suture elements
  • Suture shuttle 15 may be removed, if desired, before collapsing construct 11.
  • metal cinch ring 20 is additionally compressed by plyers about suture tails 18 and 19 and the suture lines of suture shuttle 33, if remaining, to lock them against possible movement.
  • the free ends of suture tails 18 and 19, and the free ends of suture shuttle 33 may then be cut or additionally tied and knotted as desired.
  • FIG. 6 The completed procedure is illustrated in FIG. 6.
  • the collapsible self-locking flexible construct 1 1 of flexible member 12 has been collapsed to its second closed engaging profile for locking the suture elements received in through passage 12 by applying opposed tensile load to the suture tails 18 and 19.
  • cinch ring 20 has been crimped or crushed to insure that the suture elements are retained in position.
  • the remaining free ends of suture tails 18 and 19 and suture shuttle 15 may either be cut or tied off.
  • the entire procedure can be readily carried out arthoscopically through a cannula.
  • one or more of the suture tails 18 and 19 may be applied with padding 45, such as tape or various suture configurations, where they engage the outer surface of cuff tendons 31.
  • suture leads 18 and 19 have a tape-like cross sectional area to prevent cut-through on the cuff tendons 31.
  • multiple of the flexible members 10 may be utilized in a "daisy chain" configuration to more securely attach tendons 31 to the bone 30. This is illustrated in FIG. 7, wherein elements of the two flexible members 10 are indicated with the same reference numerals, but with prime marks to distinguish parts of the separate assemblies.
  • the free ends of the exposed suture tails 18 and 19 and 18' and 19' are respectively passed through tissue in the form of tendons 31 (note that multiple puncture apertures through tendons 31 may be utilized as indicated) and then on through selected ones of the through passages of the two constructs from opposite ends of the constructs. However, in this instance the free ends of the respective suture tails 18 and 19 and 18' and 19' are also passed through the through passage of an opposite one of the collapsible self-locking flexible constructs confined within the respective bone bores 32 and 32'.
  • suture elements here the suture tails 18 and 19 and 18' and 19', between the respective bone bores 32 and 32' in order to provide a more secure coupling of the soft tissue tendons 31 to the bone 30 by the suture element portions which are engaging the tissue tendons 31 to be attached.
  • the suture shuttles 15 and 33 may take on configurations other than endless suture loops. Any elongated flexible suture shuttle may be substituted as long as it has means to secure suture elements to opposite ends thereof.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un élément flexible est utilisé pour coupler un tissu et comprend une construction flexible auto-bloquante pliable qui a un passage traversant s'étendant à travers celle-ci, s'étendant d'une première extrémité à une seconde extrémité de celle-ci, et comprend en outre des queues de suture fixées respectivement aux première et seconde extrémités de la construction et s'étendant à partir de celles-ci. La construction est construite de telle sorte que l'application d'une charge de traction opposée aux queues de suture replie la construction d'un premier profil ouvert à un second profil fermé de mise en prise pour verrouiller des éléments de suture reçus dans le passage traversant. Une navette de suture flexible est reçue dans le passage traversant de la construction et passe à travers celui-ci, les extrémités opposées de la navette étant exposées au-delà des première et seconde extrémités de la construction, pour mettre en prise et transporter des éléments de suture à travers le passage traversant de la construction depuis une première ou une seconde extrémité de la construction.
PCT/US2017/024431 2016-03-29 2017-03-28 Appareil et procédé pour coupler un tissu mou à un os WO2017172688A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662314499P 2016-03-29 2016-03-29
US62/314,499 2016-03-29

Publications (1)

Publication Number Publication Date
WO2017172688A1 true WO2017172688A1 (fr) 2017-10-05

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019079306A1 (fr) * 2017-10-19 2019-04-25 Smith & Nephew, Inc. Systèmes de réparation sans nœud de tissu
WO2023215033A1 (fr) * 2021-12-16 2023-11-09 Christopher Ninh Ensemble suture en boucle continue et techniques chirurgicales associées

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7601165B2 (en) * 2006-09-29 2009-10-13 Biomet Sports Medicine, Llc Method and apparatus for forming a self-locking adjustable suture loop
US20140236195A1 (en) * 2006-07-31 2014-08-21 Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College Soft Tissue Fixation Device
US20140257346A1 (en) * 2013-03-11 2014-09-11 Depuy Mitek, Llc Implant Having Adjustable Filament Coils

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140236195A1 (en) * 2006-07-31 2014-08-21 Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College Soft Tissue Fixation Device
US7601165B2 (en) * 2006-09-29 2009-10-13 Biomet Sports Medicine, Llc Method and apparatus for forming a self-locking adjustable suture loop
US20140257346A1 (en) * 2013-03-11 2014-09-11 Depuy Mitek, Llc Implant Having Adjustable Filament Coils

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019079306A1 (fr) * 2017-10-19 2019-04-25 Smith & Nephew, Inc. Systèmes de réparation sans nœud de tissu
WO2023215033A1 (fr) * 2021-12-16 2023-11-09 Christopher Ninh Ensemble suture en boucle continue et techniques chirurgicales associées

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