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WO2015073859A1 - Instrument chirurgical pour manipuler et faire passer un fil de suture - Google Patents

Instrument chirurgical pour manipuler et faire passer un fil de suture Download PDF

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Publication number
WO2015073859A1
WO2015073859A1 PCT/US2014/065758 US2014065758W WO2015073859A1 WO 2015073859 A1 WO2015073859 A1 WO 2015073859A1 US 2014065758 W US2014065758 W US 2014065758W WO 2015073859 A1 WO2015073859 A1 WO 2015073859A1
Authority
WO
WIPO (PCT)
Prior art keywords
suture
inner member
needle
lumen
distal section
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.)
Ceased
Application number
PCT/US2014/065758
Other languages
English (en)
Inventor
Seth A. Foerster
Thomas Weisel
Roger Pisarnwongs
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.)
Arthrocare Corp
Original Assignee
Arthrocare Corp
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
Priority claimed from US14/193,069 external-priority patent/US10265062B2/en
Application filed by Arthrocare Corp filed Critical Arthrocare Corp
Priority to AU2014348417A priority Critical patent/AU2014348417A1/en
Priority to EP14812043.9A priority patent/EP3091908A1/fr
Priority to RU2016133736A priority patent/RU2016133736A/ru
Publication of WO2015073859A1 publication Critical patent/WO2015073859A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483—Hand-held instruments for holding sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods 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
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods 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
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06009—Means for attaching suture to needle having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods 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
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip

Definitions

  • the prcseo t invention relates to a surgical instrument that can manipulate and pass suture through tissue.
  • Endoscopic surgery involves the performance of surgical, procedures through small openings and under visualization using an endoscope.
  • Access to a target tissue is normally provided through one or more portals formed directly in the patient's body or through one or more cannulas inserted into the patient's bod through small incisions.
  • a desired surgical procedure is carried out b a surgeon through the use of elongated instruments inserted through these cannulas.
  • Various endoscopic instruments have been developed to pass and retrieve suture through tissue, in some instances, retrieval of suture is accomplished by simply grasping it with regular forceps or other graspers having a suture capturing aperture formed, at the distal tip when the forceps jaws are closed.
  • Some suture retrievers include simple loops which extend from the tip of an elongated tube and which can be closed upon a suture passed through the loop.
  • U.S. Pat, No. 5,250,054 to Li discloses a suture retriever in the form of a knot tying device having an elongated inner rod slidably situated within an elongated outer sleeve. The distal end of the inner rod is provided with a pre-formed bend and the tip has a crochet-type hook to retrieve suture. This device, however, requires a separate needle to suture tissue.
  • U.S. Pal. No. 5,312,432 to Trott describes an endoscopic suturing needle having an elongated tubular housing having a needie at the distal tip and a trigger mechanism to advance and retract the needle relative to the housing.
  • the needie is pointed and flat and has a recess provided at a predetermined distance proximal to the needle tip.
  • the recess provides an opening to. capture suture material therein. This allows the needle to either push or pull suture through selected tissue. .Repeated manipulation of the suture can thus create the desired surgical stitch.
  • suture needle/retrieval devices have suture snares which are situated on or in line with the needle body . Consequently, the device must be manipulated close enough to the suture to guide the suture into a suture recei ing recess so the recess can be closed to retain the suture, hi an endoscopic procedure positioning the suture in. such close proximity to the recess can be difficult.
  • U.S. Pat. No. 5,499,995 to Garroau discloses a suture retrieve and method for manipulating suture during endoscopic surgical procedures.
  • the suture retriever has an elongated housing provided with a. solid needle tip and a lateral opening simaied proximal the needle tip.
  • a suture engaging hook is extendable through the lateral opening and awa from the axis of the housing in order to snare a suture.
  • the hook is situated at the distal end of an elongated flexible support which is pre-formed in order to enable the hook to be laterally displaced from the axis of the needle tip when the support is moved distally relati ve to the lateral opening.
  • the latter is retracted proximally in order to place and hold the suture adjacent the lateral opening.
  • hooks such as a full circle hook
  • ts that such hooks tend to increase the size of the device profile penetrating the tissue, making endoscopic surgical procedures more challenging.
  • Adding hinged ja mechanisms make it harder to work in the tight needle bends required to reach certain anatomical areas such as the inferior labium.
  • Adding such hooks at the distal end also increases the probability of inadvertently snaring tissue, and being prevented from releasing the tissue, which may damage the tissue and/or the device.
  • an endoscopic suturing instrument for manipulating suture through tissue which overcomes the above described shortcomings is still desirable.
  • A, suture manipulating instrument passes suture through tissue.
  • the instrument comprises a handle mechanism and a working distal end.
  • the working distal end comprises a needle and a preformed inner member extending therethrough.
  • the handle mechanism can be used to manipulate the needle and wire in a manner which would allo the wire to grasp and .manipulate suture by pinning and/or trapping the suture against the needle.
  • a suture instrument for manipulating and passing suture through a tissue comprises a handle; an elongate tubular shaft extending from the handle, and a needle extending from the distal section o the tubular shaft.
  • the needle comprises an outer body defining a. lumen extending therethrough, a tissue penetrating distal tip, and a laterally disposed slot along the body and in communication with said lumen.
  • the slot may extend alon the body of the needle from, a first location proximal the distal tip to the distal tip.
  • the distal tip may be hollow beveled structure.
  • the instrument may further comprise an elongate inner member such as but not limited to a. wire member.
  • the elongate inner member is movably disposed within the lumen of the needle. The inner member moves from a retracted configuration in which at least a portion of the distal section of the inner member is situated within the slot of the needle, and an extended configuration in which the distal section of the inner member extend from, the slot of the needle.
  • the distal section of the inner member preferably has a preformed shape which the distal section assumes when the inner member is i the extended configuration and the distal section is unconstrained by the lumen of the needle and wherein the preformed shape comprises a first bend which directs the distal section of the inner member at a first angle laterally away from a needle axis.
  • the distal section of the inner member and the slot of the needle cooperate together to clamp a suture disposed therebetween when the inner member is in the retracted configuration.
  • the structure of the inner member may vary widely, in one embodiment,, the inner member is branchless. In another embodiment the preformed shape of the distal section of the inner member is hook-less.
  • the diameter of the inner diameter may be constant or vary aiong die length.
  • the inner member comprises a thin flat elongate body.
  • the body may be formed from a fiat sheet of .material which is cut to shape.
  • the inner member may comprise one or more bends along its length, hi one embodiment the first bend assumes a first angle of at least 43 degrees with respect to the needle axis when the inner member is unconstrained.
  • die inner member comprises a discrete second bend distal to the first bend.
  • the second bend direct a length of the distal section of the inner member at a second angle with the needle axis, and the second angle being less than the first angle.
  • the inner wire member comprises a discrete third bend distal to the second bend.
  • the inner member comprises two dog-leg bends which collectively form, a box-hook type shape.
  • the shape of the needle may also vary.
  • the body of the needle comprises a side wall, and a suture holding section in the side wall for locating the suture when clamped between the needle and the inner member.
  • the suture holding section may comprise a recess in the side wall.
  • the recess comprises a distal surface, a base, and a proximal surface which, when the inner member is in the retracted configuration, collectively hold the suture therebetween.
  • the distal surface forms a distal ramp and the distal ramp forms art angle between 20 and 65 degrees with the needle axis.
  • the base of the suture holding section lias a length greater than 0,3 mm.
  • the recess has a depth greater than 0.3 mm.
  • the proximai surface forms a proximal ramp and the proximal ramp forms an angle greater than 90 degrees with the needle axis.
  • the suture holding section comprises an undercut in at least one of the proximai and distal surfaces.
  • the slot former comprises a wire relief section proximal the suture holding section.
  • the inner member comprises a wire bundle.
  • the inner member comprises a trapping feature
  • the trapping feature is one selected from the group consisting of a hold, ferrel, cleat, clamp, wedge, and bulb
  • the suture instrument comprises a le ver movably disposed in said handle and linked to the inner member to manipulate the inner member from the retracted configuration to the extended configuration.
  • the shape of the distal section of the needle is curved. In one embodiment the shape of the d istal section of the needle is crescent shaped.
  • the distal tip of the needle comprises an open cavity for receiving a tip section of the inner member when the inner member is retracted.
  • a suture insnumem for manipulating and passing suture through a tissue comprises: a handle; an elongate tubular shaft extending from the handle; and a needle extending from the distal section of the tubular shaft.
  • the needle comprises an outer body defining a lumen extending therethrough, a tissue penetrating distal tip, and a slot along the body and in communication with said lumen; and an elongate inner member movably disposed within said, lumen of said needle.
  • the inner member and needle cooperate together to move between a plurality of configurations including: i) a closed configuration in which at least a portion of the distal section of the inner member is situated within the slot of the needle to clamp the suture therebetween; i t.) an open configuration in which the distal section of the inner member extends from the slot of the needle and defines a suture capture zone between the inner member and the needle; and iii) an intermediate configuration- in which the inner member and the needle loosely encircle a section of suture such that the suture is sSidabiy held therebetween.
  • the distal section of the inner member has a hook-less preformed shape which the inner member assumes when the inner member is in the open configuration.
  • the inner member preformed shape comprises a plurality of discrete bends.
  • the needle comprises a crescent shape.
  • the slot comprises a plurality of sections, and said plurality of sections include a proximaliy disposed wire relief section, and. a suture holding section distal to the wire relief section.
  • a suture instrument for manipulating and passing suture through a tissue includes a handle; an elongate tubular shaft extending from the handle.
  • the tubular shaft comprises a distal section; a needle extending from the distal section of the tubular shaft.
  • the needle comprises an outer body defining a lumen extending therethrough, a tissue penetrating distal tip, and a laterally disposed slot along the body and in communication with the lumen.
  • An elongate inner member is movably disposed within the lumen of the needle, and t he inner member is .movable from a first retracted configuration in which, at least a portion of the distal section of the inner member is situated wi thin the slot of the needle, a second retracted configuration in which the entire distal section of the inner member is situated within the lumen of the needle, and an extended configuration in which the distai section of the inner member extends from, the slot of the needle.
  • the distal section, of the inner member lias a preformed shape which the distal section assumes when the inne member is in the e tended configuration and the distal section is unconstrained by the lumen of the needle.
  • the preformed shape comprises a first bend which directs the distal section of the inner member at a first angle laterally away from a needle axis, the needle axis extending through fee needle towards the distal tip of the needle; and the distal section of the inner member and the slot of the needle cooperate together to: (a) clamp a suture disposed therebetween when the inner member is in the first retracted configuration (b) strip the suture from, the inner member when the inner member is moved into the second retracted position subsequent to clamping the suture, and (e) eject the suture from the slot when the inner member is in the extended configuration.
  • the bod of the needle comprises a side wall, and a suture h olding section in the side wall for locating the suture when clamped between the needle and the inner member.
  • the suture holding section may include a recess in the side wall
  • the recess has a distal surface, a base, and a proximal surface which, when, the inner member is in. the retracted configuration, collectively hold the suture therebetween.
  • the distai surface blocks the suture from entering the lumen as the inner member is moved from the first retracted configuration, to the second retracted configuration, in embodiments the distal surface comprises a deformed tab.
  • the lumen contains a feature to strip the suture.
  • the lumen may comprise a detent blocking the suture from entering the lumen as the inner member is moved from the first retracted configuration to the second retracted configuration, or a protrusion, adapted to retard the suture from further movement in the proximal direction as the inner
  • a method of endoscopicaUy manipulating and passing suture through tissue comprises the steps of; piercing the tissue at a first location with a needle to place the needle in proximity to the suture to be retrieved; extending an elongate inner member from a lateral slot in the needle thereby creating a suture capture zone between the inner member and the needle; positioning the suture capture zone around the suture; manipulating a distal tip section of the inner member into the lateral slot of the needle while the suture is within the suture capture zone, thereby clamping the suture between the inner member and the .needle such that the suture is compressed between the inner member and the needle; and removing the needle from the tissue to retrieve the suture through the tissue.
  • clamping step is carried out by retracting the inner member through the needie.
  • the inner member is further retracted within the needle lumen, drawing a length of suture into the needle lumen.
  • the suture is subsequently ejected from the needle lumen to form a suture loop.
  • a suture push surface on the inner member enhances grabbing, pushing, and ejecting the suture.
  • the suture push surface may comprise a notch or asperity.
  • An example of an asperity is a texture elemen or burr.
  • the method further comprises piercing the tissue at a second location with the needie while the needie is carrying the suture to place the suture through the tissue, the step of piercing the tissue at a second location being performed prior to the step of piercin the tissue at a first location, '
  • the method further comprising extending the elongate inner member from the lumen in the needie thereby unclamping the suture from the inner member and the needle; and removing the needie from the tissue, thereby leaving the suture extending through the tissue.
  • the extending step is performed by extending a distal tip of the inner member in a first direction making a first angl with a needle axis of the needle and a second direction making a second angle with the needle axis, and wherein the second angle is less than the first angle.
  • the inner member is a preformed wire and comprises a plurality of discrete bends.
  • tissue to be sutured is a shoulder labrum.
  • Figure i is a perspec ti ve view of a -suture manipulating instrument holding a suture
  • Figures 2-3 are perspective and cross sectional views respectively of the working end of a suture manipulatin instrument in a retracted configuration
  • Figures 4-5 are perspective and cross sectional views respecti vely of the working end of a suture manipulating instrument in an extended configuration
  • Figures 6-7 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in a suture grasping configuration
  • Figures 8- 18 are illustrations of a surgical instrument manipulating and passing suture through tissue:
  • Figures 1 a- 1 b are perspec ti v views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively;
  • Figures 20a-20b are perspective views of the working end of another suture manipulating instrument in an extended configuration arid a suture grasping configuration respectively;
  • Figures 21a-2lb are perspective views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively;
  • Figures 22a-22d are partial side views of suture manipulating instruments- having various needle slot configurations
  • Figures 23a ⁇ 23c are partial side views of suture manipulating instruments having various wire configurations
  • Figures 24a-24b are side and cross sectional vie ws respectively of the working end of a suture manipulating instrument in a retracted configuration
  • Figure 25 is a cross sectional view of the working end of another suture manipulating instrument, in an extended configuration
  • Figure 26 is a perspective view of the working end of another suture manipulating instrument an extended configuration
  • Figures 27a-27b are perspective and side views respectively of the working end of another suture manipulating instrument in an extended configuration
  • Figures 27e-27d are side and cross sectional views respectively of the working end of the suture manipulating instrument shown in Figures 2?a-2"h in a suture grasping configuration;
  • Figures 28a-28b are side views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively ;
  • Figure 28c is an enlarged cross sectional view of the suture instrume t holding the suture shown in Figure 28b;
  • Figures 29a ⁇ 29h are side and perspective views respectively of the working end of another needle distal section and inner member in an extended configuration
  • Figures 30a-b are side and perspecti ve vie ws respecti vel of the working end of another needle distal section and inner member in an extended configuration
  • Figure 30c is a side vie of the working end of another needle distal section and inner member in an extended configuration
  • Figure 3 la is a side vie of the working end of another needle distal section and inner member in an extended configuration having a proximal undercut;
  • Figure 31b is a side view of the workins end of another needle distal section and inner member in an extended configuration having a distal undercut;
  • Figure 31c is a perspective view of the working end of another needle distal section and inner member in an extended configuration having a distal undercut;
  • Figures 32a-32b are perspective and side views respectively of the working end of another needle distal section and inner member in a retracted configuration
  • Figure 32c is a cross sectional vie of the needle distal section and inner member shown in Figure 32b;
  • Figures 33a-b are top and cross sectional views respectively of the working end of another needle distal section and inner member in an extended configuration
  • Figure 33c is a cross sectional view of the needle distal section and inner member shown in Figure 33b shown in a retracted configuration
  • Figure 34a is a perspective vie of the working end of another needle distal section and inner member shown in a retracted configuration
  • Figures 34h-34c are various cross sectional views of the needle distal section and inner member shown hi Figure 34a;
  • Figure 35a is a perspective view of the working end of another needle distal section and inner member shown in a retracted configuration
  • Figures 35b-35c are various cross sectional views of the needle distal section and inner • member shown in Figure 35a;
  • f igure 35d is an enlarged view of a distal portion of the needle and inner shown in Figure 35c;
  • Figure 36 a is a perspective view of the working end of another needle distal section and inner member shown in a retracted configuration
  • Figures 36b-36c are various cross sectional views of the needle distal section and inner member shown in Figure 36a;
  • Figures 37-38 are perspective and cross sectional views respectively of die working end o f a. suture manipulating instrument in a su ture grasping configuration
  • Figures 39-40 are perspective and cross sectional views respectively of the needle distal section and inner member shown in Figure 37, in a retracted configuration
  • Figure 41 is a perspective view of the needle distal section, suture, aad timer meaiber in an extended configuration
  • Figures 42a ⁇ 42b are side aad perspecti e view respectively of variou needle distal sections in retracted configurations
  • Figures 43-44 are perspective and cross sectional views respectively of another needle distal section and. inner member shown in an extended configuration
  • Figure 45 is a perspective view of the needle distal section, suture, and inner member of Figures 43-44, shown in an extended configuration
  • Figures 46a ⁇ 46b are side and perspective views respectively of various needle distal sections and inner members shown in extended configurations;
  • Figure 47 is a perspective view of another needle distal section, suture, and inner member shown in an extended configuration
  • Figures 48-49 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in a suture grasping configuration
  • Figure 50 is a side view of the working end of the suture manipulating instrument shown in Figures 48-49, in a further retracted configuration;
  • Figure 5la is a cross sectional view of the needle distal section, suture, and inner member shown in Figure 50, pushing the suture distally;
  • Figure 51 b is an enlarged view of the inner member gripping into the suture
  • Figure 51 c is a perspective view of the needle distal section, suture, and inner member shown in Figure 50, in an extended configuration
  • Figure 52 is an illustration of a surgical instrument manipulating passing suture through tissue
  • Figures 53-54 are side views of other needle distal sections and inner members in extended configurations
  • Figure 55 is a side view of another needle distal section and inner member shows in an extended configuration
  • Figures 56a-56b are side and front views respectively of the inner member shown in Figure 5 ;
  • Figure 57 is a side view of another needle distal section and inner member shown in an extended configuration
  • Figures 58a-58b are side and front views respectively of the inner member shown in the needle of Figure 57;
  • Figure 59a is a side view of another needle distal section and inner member shown in an extended configuration
  • Figure 59b is a side view of the inner member shown in the needle of Figure 59a;
  • Figures 60a-60b are side and front views respectively of another needle distal section and inner member in extended configurations:
  • Figures 6 c-60d are side and front views respectively of the inner member shown in the needle of Figures 59a-59h;
  • Figure 60e is a side view of another inner member having an elongate distal section:
  • Figure 60f is a side view of another inner member having a dog leg shaped distal section
  • Figures 6l a-61c are cross sectional views of the needle distal section and inner member shown in Figures 59a-59b, cooperating together to grab and dra a suture into the lumen of the needle;
  • Figure 62 is a side view of another needle distal section and inner wire member in an extended configuration.
  • FIG. L A surgical instrument .100 for manipulating and passing suture is shown in Figure L
  • the instrument 100 comprises a handle 1 ? a lever, slide, or button 2, an elongate shaft 3, and a working end 4, Slide 2 controls the suturing manipulating mechanism at the working end 4, as will described herein.
  • the instrument may be used to pass and/or retrieve suture through tissue in a wide variety of applications including, for example, labrum or rotator cuff repair,
  • FIG. 2 A detailed view of one possi ble configuration, of the working end 4 is shown in Figures 2 and 3.
  • the working end 4 is shown having a needle 5 and an inner member 6 (shown in a retracted state).
  • the needle 5 has a laterally disposed suture slot 7 and a needle point or tissue penetrating distal tip 8.
  • Needle point 8 may be formed variously, such as. for example, a bevel 9 as shown in Figure 2.
  • the suture slot 7 is preferably configured in such a manner to facilitate suture grasping when suture is pinned or damped between the inner member 6 and the walls of the needle 5.
  • the suture slot 7 has a distal ramp 7a, a vertical wail 7b, and a wire relief slot 7c, As discussed herein, features 7a and 7b can have different configurations of vertical and/or ramp walls. Additionally, the needle point 8 can be used to facilitate tissue puncturing.
  • Figures 4 and 5 show inner member 6 in an extended or deployed state with a suture 1.0 lying within the suture slot 7 of needle 5, in the embodiment shown, a single proximal bend 1.1 is preformed in the inner member 6 proximal to the inner member tip 12.
  • the inner member may be formed in such a manner that causes its tip 1.2 to move away from the needle 5 as the inner member 6 is deployed. This action creates space (e.g., a suture capture zone) between the inner member 6 and needle 5 to allow the suture 10 to slide in between the inner member 6 and needle 5.
  • Inner member is shown in this embodiment as a wire member. However, the inner member may be fabricated from other materials and. take other forms. For example, inner member may be a metal o alloy filament, braid, or wire bundle comprising one or more elements. A preferred material is super elastic materials such as itinol.
  • the inner wire 6 is retracted once the suture 1 is properl positioned between the inner wire 6 and needle 5. interaction between the proximal bend 1.3 on inner wire 6 and the suture slot 7 results in the inner wire tip 12 being displaced toward the needle axis and subsequently traps the suture 1.0, Figures and 7 show the inner wire 6 in the retracted state with a suture 1.0 clamped or pinned across the suture slot 7. In this embodiment the suture 10 is forced into a circuitous or tortuous path 13 between the inner wire 6 and the suture slot 7 which increases the hold on the suture 10.
  • Figures $ to 13 show one possible method of using the current embodiment to pass suture from one side of tissue 14 to the other.
  • tissue include without limitation !abral tissue.
  • Figure 8 shows the instrument with the inner member 6 in the extended or deployed state and in position to grab suture.
  • the device is then manipulated to position the suture 10 between the inner wire 6 and the suture slot 7 as shown in Figure 9.
  • a section of the suture 6 rests in a recess or suture capture zone 7d formed in the walls ?e, 7f of the needle 5.
  • the inner wire 6 is then retracted thereby clamping, pinning or trapping the suture 10 between the inner wire 6 and the needle 5 as sho wn in Figure 1 .
  • Figure 1 i shows piercing the tissue using the needle tip 8, thereby carrying the suture through the tissue.
  • the inner wire 6 is then deployed to release the suture 10, retracted, and then the instrument is pulled back out of the tissue 14 as shown in Figures 12 and 1 . Consequently, a section of suture is Seft extending through the tissue.
  • Figures 14 to 18 show on possible method of using the current embodiment to retrieve the suture that had previously been passed in order to form a stitch. Once the suture 1 has been passed through the tissue 54 the instrument is used to pierce the tissue 14 at second location, different from the first location.
  • Figure 15 shows the inner wire 6 deployed in order to create spacing between the inner wire 6 and suture slot 7.
  • the device is manipulated in order to position the suture 10 between the inner wir 6 and the needle 5.
  • the inner member 6 is then retracted to secure the suture 10.
  • Figure 17 shows the distal working section of the needle 5 pulled back out of the tissue 14 creating a stitch in the tissue.
  • Figure 18 shows the inner member in an extended position thereby releasing the suture 10 from the instrument.
  • the working end 4 of the needle 5 can be formed into a variety of profiles including, but not limited to those illustrated in Figures 19 to 21 ,
  • Figures 19a- 1 b show needle 5' having a relatively sharp upwards facing turn. This "U " version is shown at about 9ff , Figure 1 a shows inner wire 6' in a deployed or extended slate. And Figure 19b shows inner member 6' in a retracted suture clamping slate.
  • Figures 20a-2Ob show another needle shape, in particular, the embodiment shown in Figures 20a-20b i a 45 * "Left" version, inner member 6" is shown extended in Figure 20a, and retracted in Figure 20b.
  • the inner member is shown extended in Figure 21 a, and retracted in Figure 2.1b.
  • the suture slot 7 can be configured into a variety of profiles including, but not limited to those illustrated in Figures 22a to 22d.
  • Figure 22a shows a suture slot 7 in the body of a needle 5.
  • the slot 7 comprises a pluralit of sections or regions.
  • the suture slot 7 shown in Figure 22a includes a wire relief area 15 (also shown, for example, in Figure 34a and indicated by reference numeral 15') and a suture holding area 16,
  • Suture holding area 16 comprises a proximal ramp. 16a, a base 1 b, and a distal surface 16c.
  • Proximal ramp 16a is shown having an angle (a) with needle axis (Al).
  • Angle (a) is shown having an angle of about 135 degrees, however, the angle (a) ma vary.
  • angle (a) is equal to or greater than 90 degrees, and more preferably ranges from 90 - 1 35 degrees.
  • Proximal ramp may be vertical.
  • Figure 22b shows another suture slot 7" wife a rectangular profile and flat bottom or base
  • Figure 22c shows a suture slot 7" with a distal ramp 18 and without a proximal slot or wire relief region.
  • Distal ramp 1 S is shown ha ving an angle ⁇ ) with needle axis (Al ).
  • Angle ⁇ ) is shown having an angle of about 30 degrees, however, the angle ( ⁇ ) may vary.
  • angle ( ⁇ ) is less than 90 degrees, and more preferably from 2.0-65 degrees.
  • slot ? may include both distal and proximal ramps.
  • FIG. 22d shows an a needle 5 comprising an inner member 6 extending from an opening 19.
  • a suture (not shown) may be clamped or planed between the inner wire member 6 arid the bevel opening 19.
  • Bevel opening 19 does not include a suture holding region, or recess in its side wails as shown in other em o iments described herein.
  • the distal end of the inner member can be configured into a variety of profiles including, but not limited to those illustrated in Figures 23a ⁇ 23c.
  • Figure 23a shows the inner member as a single wire having a single tooth 20 proximal to the tip of the inner wire.
  • Figure 23b shows the inner wire with multiple teeth 21 proximal to the tip of the wire.
  • the teeth pattern can be added to improve hold strength on the suture.
  • Other options to improve grip on the suture include, but are not limited to surface treatments of the wire that may add or remove material to roughen the surface of the wire.
  • the height of the teeth may range from 0.1 -0,5 mm depending on the size of the inner member.
  • Figure 23c shows another possible configuration for the working end of the inner wire in which the wire has two or more bends at the working end.
  • the wire is configured with a first bend 1 1 and a second bend 22.
  • First bend is shown being proximal to second bend 22.
  • the first, bend is proximal to the tip of the inner wire 6 by a first distance ranging from 2-7 mm
  • the second bend is proximal to the tip of the inner wire 6 by a second distance ranging from 0.5 - 3 mm
  • First and second bends are shown forming angles (h and 3 ⁇ 4 with the needle axis AL respectively, 3 ⁇ 4 is less than i.h . 0j preferably ranges from 30-90 degrees. 3 ⁇ 4 . preferably ranges from 0-45 degrees.
  • This configuration of the instrument can be used to produce a gap, space or clearance 23 between tbe inner wire, suture, and needle to allow the suture to slide while still being trapped in the working end for suture manipulation as shown in Figures 24a-24b.
  • the inner member is sufficiently flexible such that further retraction of tbe needle further clamps the suture within the slot such that the suture may not slide.
  • Tbe instrument in such embodiments comprises an extended configuration, a suture lock or clamping configuration, and an intermediate suture sliding configuration as shown in Figures 24a-24b.
  • a working distal section of an inner member including three bends, 27a, 27b, and 27c.
  • the 3 r ⁇ i bend 27c being positioned near or at the distal tip.
  • Wire member also Includes a straight portion 28,
  • Tbe implementation of multiple bends may be used to facilitate suture sliding.
  • the working end of the inner wire and ie needle slot could constrain die suture 1.0 while providing a clearance 29 and 30, respectively, necessary to allow the suture 10 to slide.
  • a suture instrument is operable in a plurality of configurations including .1 ) a deployed or extended configuration in which the inner member extends from the needle creating a space between the inner member and needle, 2) an intermediate or suture sliding position in which the inner .member is retracted to a degree such that the suture is slidabiy held across the needle slot, and 3) a pinned or suture clamped configuration in which, the inner member s more fully retracted such that the suture is compressed into the slot and in a tortuous manner to firmly grasp the su ture and prevent the suture from sliding.
  • adding multiple bends to the inner member serves to facilitate in deployment or retraction when implemented with various needle shapes
  • the needle can be constructed from a variety of materials or combinations of materials, including but not limited to metals such as stainless steel and titanium, plastics such as polycarbonate and PEEK, or shape memor or super elastic Nitinol.
  • the inner wire can be constructed from a variety of materials or combinations of materials, including but not limited to metals such as stainless steel and titanium, or plastics such as polycarbonate and PEEK.
  • the preferred embodiment is shape memory or superelastie itinoL
  • the working end of the needle and inner member preferable has circular cross-sections, though other cross-sectional shapes might also be employed. Other shape include but are not limited to square, rectangular and ovalized cross-sections.
  • the cross-sectional area o the inner member may be constant or var along its length.
  • the inner member can be round, at the proximal end and flat at the distal, end.
  • the inner member may start off at one diameter and taper down to a lower diameter.
  • Figure 25, tor example shows an embodiment of the invention comprising an inner member 24 having a proximal section or first diameter section 24a, a second or reduced diameter section 24b, and a third, most distal section having an. enlarged diameter 24c.
  • the diameter of the inner member ranges from 0.75-2 mm. in embodiments, the ratio of the diameter of section 24a to section 24 b ranges from 25-75%.
  • the inner member can be a single wire or filament. Additionally, the inner member may comprise a wire bundle including two or more wires as shown in Figure 26.
  • wires 25 and 26 may be used to -perform the same function as a single larger wire member, implementing multiple wires would allow the wife to translate more easily through die needle while maintaining die rigidity necessary io retain suture.
  • the wires can be attached or detached at die ends or along the length of the wire by adhesives, bonds, fusing, and other attachment techni ues known to those of skill in the art.
  • Figures 29a-b show a needle body distal section 31 comprising a single slit 32 which would allow the inner wire to deploy from the needle.
  • Single slit 32 preferably, but not necessarily, is wide enough to allow suture to engage with the inner wire and needle in a similar manner to that illustrated in Figures 6 and 7,
  • Single slit 32 differs from, some of the needle configurations described herein in that a suture holding region or recess in the needle walls is absent in the single slit (e.g., single slit lacks the suture holding region 16 of Figure 22a).
  • Figures 30a- 0b show a working end of the needle body 34 comprising a single cutoff 33a with a shoulder 33b. This configuration would allow relief for the inner wire while still providing a constraining path for the suture (see, e.g.. Figures 6 io 7). Additionally, as shown in Figure 30c, the cutoff may have serrations 35, a roughened surface via for example a surface treatment, or another grip feature in order to provide added sutur retention force.
  • Figures 3.1a ⁇ 3 l c illustrate additional possibl configurations for the suture slot at the working end of the needle in which a. hook or undercut may be used to facilitate suture retention and or manipulation.
  • Figure 31a shows a suture slot with a proximal hook/undercut 36.
  • the undercut 36 is formed in the wall of the needle body.
  • Inner member is shown having two bends in this embodiment.
  • Figure 31b shows a suture slot comprising a distal hook/undercut 37.
  • Inner member is shown having three bends in this embodiment.
  • the needle may comprise a hollow or solid tip or end.
  • Figure 31c shows a suture slot with a distal hook/und.ereut 37 and a solid needle tip 38,
  • the solid tip may facilitate tissue penetration.
  • the solid tip may also work in conjunction with the inner wire to form clearance for suture sliding with or without multiple bends at the working end of the inner wire.
  • the solid tip can be formed by a variety of methods including bat not limited to filling in the needle tip with a solder or epoxy,
  • a plastic rod can be bonded or mechanically attached within the inner diameter of the needle to form the solid tip.
  • a metal rod can also be welded, bonded or mechanically attached within the inner diameter of the needle to form the solid tip.
  • the inner member shown in Figure 31c ncludes two bends. However, as described herein the inner member ma have one or more bends depending on the desirability of suture clamping force, and whether an intermediate suture sliding position is desired.
  • Figures 32a-32e illustrate another embodiment of a distal section of a needle 100 and inner member 1 10 in a retracted configuration.
  • the distal section of the needle comprises a needle body 132 having a gently curved crescent shaped profile, a sharpened distal tip 1 20. and a lumen 134 extending therethrough.
  • the inner member 1 10 is operable to move from a retracted position to a deployed or extended position from, the needle body.
  • a suture not shown may be clamped or grasped between the inner member and needle when the inner mem er is in the retracted position.
  • the embodiment shown in Figures 32a-32c includes a suture slot 130,
  • the suture slot 130 comprises a plurality of sections including a wire relief section 142, and a suture holding section 144,
  • the inner member 1 10 is shown in a retracted position, and has an inner member tip portion disposed within slot 130.
  • suture holdin section 144 is shown as a recess in the side walls or bod of the needle 1 0.
  • Suture holding section 144 comprises a proximal shoulder or surface 146, a base or trough section 148, and a distal ramp 150.
  • the dimension and angles and of the features are preferabl in the range as described herein such as hut not limited to the embodiments shown in Figure 22.
  • the suture holding region 544 serve to clamp the suture when the inner member is retracted.
  • the degree of clamping may be bolstered by modifying the design including for example, material selection, increasing the width of the trough 148, increasin the number of bend angles present in the inner member, or increasing the degree of the bend angles of the inner member.
  • suture release form the instrument may be facilitated by, amongst other things, decreasing the distal ramp angle so as to allow the suture to slide more freely out of the virtual jaw grip formed between the needle and the inner member.
  • Many features of the described embodiments may be modified to achieve a desired design, result or application, and such modifications are intended to be part of the invention.
  • the invention is intended only to be limited as set forth in the appended claims.
  • Figures 33-36 illustrate various constraining features to further hold the imier member, trapping the suture, when the suture instrument is in the retracted suture-clamping configuration.
  • Figures 33a-33b illustrate a distal needle section 200 including a needle body 202, a tissue penetrating distal tip 204, a lumen 206 extending therethrough, and a suture slot 208.
  • Inner member 212 is shown ha v ing a plurality of bends and in a deployed configuration, inner member extends away from the needle body. As described herein, spacing the inner member away from the needle body as shown in Figures 33a-33b serves to create a space within which the suture (not shown) may be inserted or placed.
  • Figure 33e shows inner member 212 in a retracted configuration.
  • Distal section of the inner member is substantially disposed within the suture slot 208 and in particular, a distal tip or end 214 of the inner member is rotated or manipulated until it is fit within hole or aperture 216 in the needle body 202,
  • Figures 34a-34c show another needle distal section and inner member in a retracted configuration.
  • the embodiment shown in Figures 34a-34c differs from that shown m Figures 33a-33c in that the embodiment shown, in Figures 34a-34e includes a ferrel type constraining feature.
  • ferrel 224 comprises a cylindrical body having a cavity to receive the tip of the inner member 222.
  • Ferrel 224 may be bonded or otherwise affixed within the slot 226 of the needle section.
  • the ferrule 224 is attached to the wire 222 and is pulled into the tube such that the ferrule restricts the wire from being pulled perpendicular to the needle axis by having a larger diameter than the width of the narrowed portion (or neck 225 ⁇ of the suture slot 226.
  • Figures 35a-35d show another needle distal section 230 and inner member 232 in a retracted configuration.
  • the embodimen shown in Figures 35a-35d differs from that shown above in that the embodiment shown in Figures 35a-35d includes a cleat type constraining feature 234.
  • Cleat 234 includes an abutment surface or lip which snugly holds the distal end of the inner member when the inner member is retracted.
  • Figures 36a ⁇ 36c show another needle distal section 240 and inner member 242 in a retracted configuration.
  • the embodiment shown in Figure 36a-36c differ from that shown above in mat the embodiment shown in Figures 36a ⁇ 36c includes a bulbous constraining feature 244,
  • the inner member 242 terminates in a rounded spherical shape 244, The bulb snugly fits within the needle slot (e.g., by interference fit).
  • Bulb 244 may be bonded or otherwise affixed to inner member, or may he formed as part of the inner member.
  • the above described constraining features serve to further or redundantly secure inner member within the slot to prevent deployment of the inner member, and to preveiit inadvertent release of the suture.
  • embodiments of the invention facilitate suture release from the instrument after the suture has been clamped.
  • inner member 312 e.g., a preformed wire holds suture 314 in place by pinching t against needle 316.
  • inner member 312 is moved distaily. This unciaxnps the pinching force on the suture 314.
  • the suture can remain in the suture recess or slot 18 of the needle 316, making it difficult to release the suture when performing an arthroscopic, procedure .
  • the suture is released from the inner member despite the bias to remain in slot 318.
  • inner member 312 is shown being retracted in the proximal direction and, as the inner member 312 is retracted, it rides over (and clears) the suture 314. Consequently, the suture remains within suture recess 318 and is not dragged into inner lumen 313. In a sense, the suture 314 is stripped from the inner member 312.
  • inner member 312 is pushed distaily, thus ejecting the suture 314 out of the suture recess 3 i 8.
  • Figures 42a ⁇ 42b show additional features serving to prevent the suture 314 from being- drawn or sucked into the inner lumen tube 320.
  • a detent 322 is placed in the floor of the needle 16.
  • tabs 32.4 are deformed near the proximal portion of the opening 326.
  • the features shown Figures 42a-42b serve to ship the suture 314 off inner member 312 as the inner member is pulled proximally into the inner lumen 320. The suture may then be more easily released or ejected from the instrument.
  • a snipping means such as a tab or detent may be disposed at one or more locations along the needle i umea.
  • the feature may extend up to a full diameter of the inner lumen. Additionally, the feature may extend abou t the entire circumference. Or, the feature may be limited to an arcuate segment,
  • a protrusion to strip the suture may be positioned within the lumen, or at the entrance of the Iumea.
  • the suture may thus be stripped from the inner member inside die lumen or outside the iumen.
  • Figures 43-44 arc perspective and cross sectional views respectively of the working end of another needle distal section 410 and inner member 41 2 shown in an. extended configuration. More specifically. Figures 43-44 show a perspective and cross-sectional view of an inner member 4 2 that has been deployed more dista!iy than the embodiments shown in Figures 37- 42. As described herein, extending the inner member pushes the suture 416 out of the suture recess 14. Figure 45 shows the suture 416 having been pushed out of the suture slot 414 by the distaliy deployed inner member 412.
  • Figures 46a-46b show embodiments of an instrument, including features serving to facilitate the suture eject (or push-out) method described .herein.
  • Figure 46a shows inner member 412 having a notch 418, Notch 41 S aids in 'grabbing' the suture as the inner member 412 is being deployed distally.
  • Figure 46b shows another feature to facilitate ejecting or pushing out the suture as the inner member is pushed distally.
  • Figure 46b shows a sleeve 420 coaxiaUy surrounding th inner member 12 thus creating a shoulder to catch the suture (not shown).
  • a pushing suture means may extend a full or partial diameter, and be located at one or more places along the wire,
  • Figure 47 is a perspective view of the working ead of another needle distal section 510 and inne member 514 in an extended, configuration.
  • the inner member 514 has been, extended, deploying suture 512.
  • the needle 510 and recess 5.1 may be the same shape as described herein except that the inner member 514 (shown as a wire) has a grasping ring 51.6 located neat' the distal end of the inner member.
  • Figures 48-49 are perspective and. cross sectional views respectively of the working end of the needle 510 shown is a suture grasping configuration.
  • the inner member 514 is shown pinching the suture 512 to hold it in. the suture slot 51 .
  • the suture may he subsequently drawn into the inner lumen 520 of needle 510 by -further retracting the inner member 514 to a second or more proximal location.
  • Figure 50 is a cross sectional view of the needle distal section shown in Figures 48-49, shown with the inner member in a further retracted configuration.
  • inner member 514 has been pulled, proximalfy into the inner (umen 520, dragging the suture 512 into the inner lumen with the aid of the grasping ring 516.
  • Figure 51a is a cross sectional view of the working end of the needle distal section, suture, and inner member 514 wherein the inner member is shown being moved disially within the lumen 520, and urging the suture in the direction (A).
  • Figure 51b shows an enlarged view of a gripping feature 516 acting on the suture 512.
  • the gripping features 516 partiall press,, compress, cut into, capture and/or pierce the suture
  • the gripping features may have serrations or corners that, the suture fibers stick to, hang up on, or become entangled. These gripping features reliably serve to maneuver the suture 512 proxhna!ty and disrally and to eject the suture from the inner lumen 5:20.
  • Such gripping features may vary widely and include serrations, corners, notches, rings or other structures and geometries.
  • Figure 51c is a perspective view of the working end of the needle distal section, suture, and inner member shown in Figure 50, in an extended or deployed configuration. In part.ieu.lar. Figure 51 c shows the suture 522 having been pushed out of the inner lumen 520 by grasping feature (and or pushing means) 516 located on inner member 514.
  • Figure 51 c also shows suture having a relatively large suture loop 522,
  • the suture loop 522 is approximately equal to the length of suture (3 ⁇ 4) pulled into the inner lumen 520.
  • This relatively large loop 522 is advantageous in arthroscopic surgery because it may be more easily grabbed by a surgeon than a smaller loop.
  • Figure 52 shows suture passer 510 penetrating through tissue 524 and carrying the suture
  • the size of the loop created by the instrument may be selectively set during a procedure, or predetermined.
  • the handle may include a lever as described herein and have a lever path or slot in the handle for the lever to move.
  • the lever may be coupled to the inner member such that the length of travel through the lumen during the retraction step coincides with, the length of travel of the lever.
  • the handle and lever may be marked to indicate the loop-size increments.
  • the handle, lever and inner member may include hard stops and a limited range of motio to prevent undesirable-sized loops.
  • a lever path may be shaped to limit the length that the lever may travel (e.g. a 0,3 t 0.5 inch ami in some embodiments about 0.4 inch long rectangular slot).
  • An exemplary range for the length of the large loops (Lj.) described herein are 0.3 to 0.5 inches, and more preferabl between about 0.4 fetches.
  • Figure 53 shows a trough or detent 534 for catching and manipulating the suture in the proximal and distal direction.
  • the protruding surfaces may be formed by two rings affixed to the shaft and spaced apart, a small distance to form the trough.
  • Figure 54 shows a cut or notch 544.
  • These features interact with, namely, grab, draw, and push the suture.
  • Many variations of the grasping feature and means are intended to be included as part of the invention unless specifically excluded by the appended claims.
  • rings may extend partially around the circumference of the inner member.
  • Protrusions, detents, cuts e.g. a spiral cut
  • the feature may comprise frictional means such as a surface roughening, asperity, burr, or frictional material which presents greater frictional force on the suture than on the wall of the inner lumen.
  • frictional means such as a surface roughening, asperity, burr, or frictional material which presents greater frictional force on the suture than on the wall of the inner lumen.
  • Figure 55 shows another structure adapted to grasp and draw the suture into the needle.
  • the inner member comprises a dogleg distal section.
  • the dogleg tip serves to assist in drawing the suture into the lumen during the retraction step of the procedure described above.
  • Figures 56 " a-56h are side and front views respectively of the inner member shown in Figure 55.
  • the inner member 552 is shown comprising an elongate section 554, terminating at a first bend 556,
  • a non limiting exemplary range for the length of the elongate section 554 is between 8 and.9 inches.
  • a non limiting exemplary range for the first angle of is between 70 and 85 degrees, and mor preferably between 75 and 80 degrees.
  • the dogleg is characterised by a lateral extending leg portion 558 and a second bend 560.
  • An exemplary range for the length of the leg portion 558 is between 0.2 and 0,3 inches.
  • the second bend angle may range from 80-90 degrees, and preferably from 85-89 degrees.
  • the length of the tip segment 562 may range from 0.5 to 0.7 inches. Additionally, the diameter of the inner member may range from 0.015 to 0.025 inches.
  • Figure 57 is a side view of another embodiment showing inner member 570 in an extended configuration.
  • the inner member 570 comprises a crochet shaped distal section 572.
  • the crochet tip serves to assist in drawing the suture into the lumen, during the retraction step (as well as pushing the suture out of the lumen) during a procedure as described above.
  • Figures 58a--58b are sid and front views respectively of the inner member 570 shown in Figure 57.
  • An elongate shaft extends to a first bend 571.
  • a lateral segment extends from the first bend to second bend 573.
  • a third bend 574 forms the crochet-shaped end portion.
  • Many of the dimensions may be similar to that described above in connection with Figures 56a-56b except thai the crochet tip extends and forms- a smooth rounded semi circle.
  • the semi circle shape is advantageous over full circle hook because a full circle hook can have a tendency to fail to release the suture, and fail to smoothly fit within an arthroscopic needle,
  • a Bon-l nitmg exemplary inner radius 574 and outer radius 576 for the crochet tip is approximately 0.0! 5 and 0.040 inches respectively.
  • a non-limiting exemplary height 578 ranges from 0.2 to 0,3 inches.
  • Figure 59a is a side view of the working end of another suture passing instrument showing inner member 580 in an extended configuration.
  • Hie inner member comprises a box shaped distal section 582.
  • the box shaped tip serves to assist drawing the suture into the lumen during the retraction step (as wei! as pushing the suture out of the lumen).
  • Figure 59b is a side view of the inner member shown in Figure 59a, An elongate shaft extends to a. first bend (A). A lateral segment extends from the first bend to second bend (B), Second bend extends to a third bead (C). A base region forming the bottom of the box extends to fourth bead (D).
  • FIG. 59a-59b Many of the dimensions ⁇ e.g., shaft outer diameter jODj) shown in Figures 59a-59b may be similar to that described above in connection with Figures 58a-58b except that the box shaped tip 582 comprises a pair of dog-leg or right angles to make a box-like shape instead of a rounded semi-circle or crochet end.
  • a non-Kmiting exemplary depth 584 of box is approximately 0.04 to 0.06 inches respectively.
  • a non-limiting exemplary height 586 ranges from 0,2 to 0.3 inches.
  • Figures 60a-60b are side and front views respectively of the working end of another embodiment showing inner member 594 shown in a deployed or extended configuration.
  • the inner member 594 comprises an open trapezoidal-shaped (or parallelogram-shaped) suture grasping cavity 596.
  • the grasping region may be defined by a pair of side walls separated b a width (W.) and having a depth (D).
  • W. width
  • D depth
  • the side walls are shown at different angles from one another. However, the side walls or portions of the side walls may be parallel or close to parallel with one another. Additionally, as shown, the shape or curvature of each of the side walls may vary and may be different from, one another.
  • the distal most side wall has a greater curvature than the more proximal side wall.
  • the grasping space 596 serves to move the suture within the needle as will be described in more detail herein.
  • the inner member 594 shown in Figures 60a-60d may be made from a flat sheet.
  • the inner member 594 is shown having a thickness (ti) in the range from 0.01 to 0.03 inches, and more preferably about 0.02 inches, its sides may be flat.
  • the height (H) may range from 0.25 to 0.35 inches.
  • Such an inner member may be machined to size, or otherwise formed by removing or cutting away material from a flat sheet.
  • Exemplary materials include stainless steel, spring steel or Nitinol. No shape setting is required. The shapes may be cut using well know conventional machining techniques (such as EDM) or otherwise formed. Additionally, in certain embodiments, thin sheets may be stacked together and machined to shape as a batch.
  • the Hat inner member 594 has varying stiffness along its length.
  • the stiffness may be adjusted b varying the cross section, effective diameter or thickness of the member along its length.
  • the tip section 596 comprises a stiffness sufficient to grasp the suture whereas the elongate straight base sections are relatively more flexible to allow for these sections to eiasticai! deform while advanced through the curves of the needle lumen in the distal section of the needle.
  • the inner member's varying cross sectional size allows for only elastic deformation in certain portions of the inner member (e.g., proximal sections) while allowing other portions of the inner member (e.g., the distal tip) to be relatively stiff, hi certain embodiments, the proximal section is narrower or thinner than the distal tip section.
  • the distal tip section has a larger cross section than the proximal section in embodiments. Even when the distal section is placed under stress, it will not deform and can hold onto the suture.
  • the inner member comprises a "flat wire” design, and has a larger distal cross section than the proximal section.
  • the invention is not so limited and other cross sectional shapes may be employed.
  • the flat cross section can enable about two times or more the torsional stability of the inner member within the tieedle lumen than a round cross section while retaining substantially the same elastic deformation and flexibility of the inner member.
  • torsional stability ft is meant the ability to maneuver between obstacles such as suture and tissue without plastically deforming, buckling, or twisting.
  • the inventors have found that being able to vary the cross section of the inner member has enabled a three to four times greater functionality in suture retention,
  • the cross section along the inner member varies.
  • the cross section is relatively small along the proxiraal section.
  • the smaller cross section allows for elastic deformation of the inner member as it is advanced through the needle lumen.
  • the cross section of the inner member is larger towards the distal tip.
  • the larger cross sectio at the distal tip provid.es enhanced stiffness to grab and pull the suture.
  • an inner wire having a uniforra-sized cross section may be robust enough to sufficiently grasp a suture but is undesirably susceptible to plastic deformation due to the influence of curves in the needle lumen.
  • the inner member is less likely to elastieaily deform and more likely to plastically deform due to the influence of the needle lumen. This effect is magnified in more tortuous versions of the needle tip such as the instruments shown in Figures 19 and 20
  • the distal tip section will lack the stiffness to grab the sutures and may ultimately plastically deform such that consistent suture grasping is difficult
  • a varying cross section is a preferred embodiment.
  • the invention is only intended to he limited as recited in the appended claims, and in embodiments, the inner member wire has a cross section that is uniform along its length.
  • Figure 60c also shows an atruamatie nose tip 596.
  • a tip may be machined or otherwise formed on the tip of the hook.
  • a pointed nose tip enables easie maneuvering of the instrument.
  • a smooth pointed nose tip may serve to separate sutures extending from an anchor such that at least one of many suture tails may be selected, and captured.
  • a suture bundle may be more conveniently approached and separated, with a nose tip as shown in Figure 60c.
  • Figure 60e shows a side view of another flat inner member 602 comprising an elongate box-shaped hook 604, in particular, the length, of the base portion Wj ranges from 0.02 to 0, 2 inches. Additionally, the proximal, section of the wire has thickness (tj) of 0, 1.5 to 0,045 inches (and in one embodiment tj is about 0.02 inches). Thickness (3 ⁇ 4) tapers to a smaller dimension towards the distal portion and is limited by the ID of the needle. In embodiments, the thickness (tj) is such that the inner member fits smiggly in. the ID of the needle.
  • Figure 60f shows a aide view of another flat inner member 612 comprising an. elongate dog leg-shaped hook 614.
  • the length of the hook portion H ranges from 0.02 to 0.12 inches, and preferably is about 0.04 - 0,05 inches.
  • Radius I (R;) is about 0.08 inches (consequently forming an angle (iheta) ranging from about 45-90 degrees, and more preferably between about 45-60 degrees. Radius 2 ⁇ 3 ⁇ 4) is about 0.01 - 0.02 inches.
  • the proximal section of the wire has thickness (h) of 0.005 to 0.045 inches (and in one embodiment tj is about 0.02 inches).
  • Thickness i3 ⁇ 4) tapers to a smaller dimension ( ) towards the distal portion and is limited by the ID of the needle, in certain embodiments, the thickness (3 ⁇ 4) is such that the inner member fits straggly in the ID of the needle, in the structure shown in Figure 60f, (u) is about 0.05- 0.2 inches. Thickness (is) is about the same as (t»). Thickness (3 ⁇ 4) is shown being larger than (tj) and in embodiments, ranges from 0.005 - 0,2 inches. As mentioned herein, the dimensions (e.g. , angles, lengths., and thickness') of the embodiments may vary and be interchangeable with the dimensions of another embodiment except where such dimensions or features are mutually exclusive.
  • Figures 6 la-6lc are cross sectional views of the needle distal section 592 and inner w re member 594 shown in Figures 60a-60b, cooperating together to grab and draw a suture 600 into the needle lumen 598.
  • the inner member 94 ha been exteiided, creating a suture capture zone, The instrument is manipulated such that the suture 600 is positioned between the needle slot 593 and the inner member 594,
  • Figure 61b is a cross sectional view of the needle distal section 592 shown in a suture grasping configuration.
  • the inner member 594 is shown pinching the suture 600 to hold, it in the suture slot 593,
  • Figure 61c is a cross sectional view of the needle distal section 592 shown in a further retracted configuration.
  • inner member 594 has been pulled proxinially into the inner lumen 598, dragging the suture 600 into the inner lumen with the aid of the grasping feature 596.
  • a suture loop may be formed which is approximately equal to the length of suture pulled into the inner lumen 598. This relatively large loop is advantageous in arthroscopic surgery because it may be more easily grabbed by a. surgeon than a smaller loop.
  • a method comprises the following steps: a) grasping the suture, b) drawing the suture into the lumen, and c) ejecting the suture from the instrument.
  • suture grasping and drawing forces may be compared to a suture pull out force.
  • pull out force it is meant a maximum force applied to the suture until, the suture is pulled out from the target material or instrument.
  • Nitinol Wire 2.8 2.8 Relatively low memeiout One Ring force. Highly navigable through needle lumen without plastic deformation.
  • the structures described above in the table operated to effectively navigate through an arthroscopic needle without any plastic deformation, grasp and pull the suture into the lumen with the forces listed above, and subsequently ejec t the suture from the needle to varying degrees of success.
  • the flat Nitinol wire with a trapezoid-shaped distal tip section showed a marked increase in suture pull out strength without any sacrifice in the ability to eject a suture, or suffer from plastic deformation.
  • This data supports a conclusion that embodiments described herein (a) provide desirable suture pull out strength, (b) are easily navigable through the needle lumen without plastically deforming, and (c) predictably eject or release the suture from the instrument.
  • the described inner wires advantageously display a combination of stiffness at one region for firmly grasping the suture tail, but also a flexibility at other regions so as to avoid plastic deformation.
  • embodiments of the invention described herein provide excellent suture pull out strength- and suture ejection because of a combination of unique characteristics including but not limited to the cross sectional shape of the inner wire, the variation in cross section along its length, the number of bends along its length, the angle of the bends, and the shape of the suture capture zone.
  • Figure 62 shows a side view of another needle distal section 710 and inner wire member combined in an extended configuration.
  • the needle distal section 712 differs om the embodiment shown in Figures 61a-6Se in that the slot, profile is different.
  • the needle wall shown in Figure 62 includes a discrete cut out or recess whereas the slot profile shown in Figures 6ta-6lc has a shoulder or step design.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Instrument de manipulation de fil de suture destiné à faire passer et à récupérer un fil de suture à travers un tissu, comprenant un mécanisme de poignée, une tige allongée s'étendant depuis la poignée, et une extrémité distale de travail. L'extrémité distale de travail comprend un corps d'aiguille, une lumière définie par le corps d'aiguille, un embout distal de pénétration de tissu, et une fente latérale. Un élément interne préformé est disposé de manière à pouvoir se déplacer à l'intérieur de la lumière de l'aiguille. Le mécanisme de poignée sert à faire sortir le fil métallique de la fente latérale de l'aiguille, et à rétracter le fil métallique dans la fente latérale, ce qui permet à l'extrémité de travail de l'instrument de saisir et de manipuler le fil de suture en fixant et/ou en piégeant le fil de suture contre l'aiguille. Dans des modes de réalisation, l'élément interne est encore plus rétracté dans la lumière de l'aiguille, tirant ainsi une longueur de fil de suture dans la lumière de l'aiguille. Le fil de suture est ensuite éjecté de la lumière de l'aiguille pour former une boucle de fil de suture.
PCT/US2014/065758 2013-11-15 2014-11-14 Instrument chirurgical pour manipuler et faire passer un fil de suture Ceased WO2015073859A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2014348417A AU2014348417A1 (en) 2013-11-15 2014-11-14 Surgical instrument for manipulating and passing suture
EP14812043.9A EP3091908A1 (fr) 2013-11-15 2014-11-14 Instrument chirurgical pour manipuler et faire passer un fil de suture
RU2016133736A RU2016133736A (ru) 2013-11-15 2014-11-14 Хирургический инструмент для управления шовным материалом и его проведения

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361905064P 2013-11-15 2013-11-15
US61/905,064 2013-11-15
US14/193,069 US10265062B2 (en) 2012-02-07 2014-02-28 Surgical instrument for manipulating and passing suture
US14/193,069 2014-02-28

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WO2015073859A1 true WO2015073859A1 (fr) 2015-05-21

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AU (1) AU2014348417A1 (fr)
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WO (1) WO2015073859A1 (fr)

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Publication number Priority date Publication date Assignee Title
US20240016490A1 (en) * 2020-10-28 2024-01-18 Smith & Nephew, Inc. Surgical instrument for manipulating and passing suture

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011008607A1 (fr) * 2009-07-15 2011-01-20 Pivot Medical, Inc. Méthode et appareil de traitement de l'articulation de la hanche, notamment au moyen d'un nouvel instrument de passage de suture, et instrument associé
WO2012034131A2 (fr) * 2010-09-10 2012-03-15 Pivot Medical, Inc. Procédé et appareil permettant de passer un point de suture à travers un tissu
WO2013082072A1 (fr) * 2011-12-02 2013-06-06 Ethicon, Inc. Dispositif d'insertion médical et procédé d'utilisation
WO2013119592A1 (fr) * 2012-02-07 2013-08-15 Arthrocare Corporation Instrument chirurgical pour manipuler et passer une suture
US20140222033A1 (en) * 2012-02-07 2014-08-07 Arthrocare Corporation Surgical instrument for manipulating and passing suture

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011008607A1 (fr) * 2009-07-15 2011-01-20 Pivot Medical, Inc. Méthode et appareil de traitement de l'articulation de la hanche, notamment au moyen d'un nouvel instrument de passage de suture, et instrument associé
WO2012034131A2 (fr) * 2010-09-10 2012-03-15 Pivot Medical, Inc. Procédé et appareil permettant de passer un point de suture à travers un tissu
WO2013082072A1 (fr) * 2011-12-02 2013-06-06 Ethicon, Inc. Dispositif d'insertion médical et procédé d'utilisation
WO2013119592A1 (fr) * 2012-02-07 2013-08-15 Arthrocare Corporation Instrument chirurgical pour manipuler et passer une suture
US20140222033A1 (en) * 2012-02-07 2014-08-07 Arthrocare Corporation Surgical instrument for manipulating and passing suture

Also Published As

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RU2016133736A (ru) 2018-02-22
AU2014348417A1 (en) 2016-09-29
EP3091908A1 (fr) 2016-11-16
RU2016133736A3 (fr) 2018-06-13

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